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BAUSCH HEALTH COMPANIES INC. – 10-Q – Management's Discussion and Analysis of Financial Condition and Results of Operations
INTRODUCTION
Unless the context otherwise indicates, as used in this "Management's Discussion and Analysis of Financial Condition and Results of Operations," the terms "we," "us," "our," "the Company," "Bausch Health ," and similar terms refer toBausch Health Companies Inc. and its subsidiaries, taken together. This "Management's Discussion and Analysis of Financial Condition and Results of Operations" should be read in conjunction with the unaudited interim Consolidated Financial Statements and the related notes (the "Financial Statements") included elsewhere in this Quarterly Report on Form 10-Q for the quarterly period endedSeptember 30, 2022 (this "Form 10-Q"). The matters discussed in "Management's Discussion and Analysis of Financial Condition and Results of Operations" contain certain forward-looking statements within the meaning of Section 27A of The Securities Act of 1933, as amended, and Section 21E of The Securities Exchange Act of 1934, as amended, and that may be forward-looking information within the meaning of applicable Canadian securities laws (collectively "Forward-Looking Statements"). See "Forward-Looking Statements" at the end of this Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. Our accompanying unaudited interim Consolidated Financial Statements as ofSeptember 30, 2022 and for the three and nine months endedSeptember 30, 2022 and 2021 have been prepared in accordance with accounting principles generally accepted inthe United States of America ("U.S. GAAP") and the rules and regulations of theUnited States Securities and Exchange Commission (the "SEC") for interim financial statements, and should be read in conjunction with our Consolidated Financial Statements for the year endedDecember 31, 2021 , which were included in our Annual Report on Form 10-K filed onFebruary 23, 2022 . In our opinion, the unaudited interim Consolidated Financial Statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for a fair statement of the financial condition, results of operations and cash flows for the periods indicated. Additional company information is available on SEDAR at www.sedar.com and on theSEC website at www.sec.gov. All currency amounts are expressed inU.S. dollars, unless otherwise noted. Certain defined terms used herein have the meaning ascribed to them in the Financial Statements.
OVERVIEW
We are a global company whose mission is to improve people's lives with our
health care products. We develop, manufacture and market, primarily in the
therapeutic areas of gastroenterology ("GI") and dermatology, and eye health, a
broad range of: (i) branded pharmaceuticals, (ii) generic and branded generic
pharmaceuticals, (iii) over-the-counter ("OTC") products and (iv) medical
devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and
aesthetics devices), which are marketed directly or indirectly in approximately
100 countries.
Our portfolio of products falls into five operating and reportable segments: (i)
Salix, (ii) International (formerly International Rx), (iii) Solta Medical , (iv)
Diversified Products and (v) Bausch + Lomb. These segments are discussed in
detail in Note 19, "SEGMENT INFORMATION" to our unaudited Consolidated Financial
Statements. The following is a brief description of the Company's segments:
•The Salix segment consists of sales in the U.S. of GI products. Sales of the
Xifaxan® product line represented 80% of the Salix segment's revenues for each
of the three and nine month periods ended September 30, 2022 .
•The International segment consists of sales, with the exception of sales of
Bausch + Lomb products and Solta aesthetic medical devices, outside the U.S. and
Puerto Rico of branded pharmaceutical products, branded generic pharmaceutical
products and OTC products.
•The Solta Medical segment consists of global sales of Solta aesthetic medical
devices.
•The Diversified Products segment consists of sales in the
pharmaceutical products in the areas of neurology and certain other therapeutic
classes, (ii) generic products, (iii)
products and (iv) dentistry products.
•The Bausch + Lomb segment consists of global sales of Bausch + Lomb Vision
Care,
During the first quarter of 2022, the Company changed its segment structure. The new segment structure resulted in a change to the Company's former Ortho Dermatologics segment whereby its medical dermatology business (Ortho Dermatologics ) is now managed by the Chief Operating Decision Maker ("CODM") as part of the Diversified Products segment and theSolta Medical business is now managed by the CODM as its own operating and reportable segment. Prior period presentation of segment revenues and segment profits has been recast to conform to the current reporting structure. 50 --------------------------------------------------------------------------------
Our Focus on Value
In 2016, we implemented a multi-year plan designed to transform and bring out value in our Company. The multi-year plan increased our focus on, among other factors, our: product portfolio, infrastructure, geographic footprint, capital structure and risk management. Since that time, we have been executing and continue to execute on our commitments to transform the Company and generate value. As discussed below, under the multi-year plan, we have taken actions that among other things included: (i) divesting non-core assets, (ii) making strategic investments in our core businesses and (iii) making measurable progress in improving our capital structure. These measures gave us operating flexibility and put us in a strong position to unlock the additional value to be found in our specific businesses. We believe that these and other actions we have taken to transform our Company, have helped to focus our operations, and improve our capital structure. These positive actions also presented us with an opportunity to unlock potential value across our portfolio of assets by separating our pharmaceutical and eye health businesses. Although management believes the B+L Separation (as defined below) will bring out additional value, there can be no assurance that it will be successful in doing so.
Separation of the Bausch + Lomb Eye Health Business
OnAugust 6, 2020 , we announced our plan to separate our eye health business consisting of our Bausch + Lomb Global Vision Care (formerlyVision Care/Consumer Health ),Global Surgical and Global Ophthalmic Pharmaceuticals businesses into an independent publicly traded entity, Bausch + Lomb Corporation ("Bausch + Lomb") from the remainder ofBausch Health Companies Inc. (the "B+L Separation"). DuringMay 2022 , a wholly owned subsidiary of the Company (the "Selling Shareholder") sold shares of Bausch + Lomb pursuant to the initial public offering ("IPO") of Bausch + Lomb (the "B+L IPO"). The underwriters partially exercised the over-allotment option granted by the Selling Shareholder. The Company indirectly holds 310,449,643 common shares of Bausch + Lomb, which represents approximately 89% of Bausch + Lomb's outstanding common shares. We continue to believe that completing the B+L Separation makes strategic sense. The completion of the B+L Separation is subject to the achievement of targeted debt leverage ratios and the receipt of applicable shareholder and other necessary approvals. We continue to evaluate all factors and considerations related to the B+L Separation, including the effect of the Norwich Legal Decision (see "Xifaxan® Paragraph IV Proceedings" of Note 18, "LEGAL PROCEEDINGS" to our unaudited interim Consolidated Financial Statements) on the B+L Separation.
The B+L Separation, if consummated, will result in two separate, independent
companies:
•Bausch Pharma - a diversified pharmaceutical company with leading positions in gastroenterology, hepatology, dermatology, neurology and international pharmaceuticals, and aesthetic medical devices. The remaining pharmaceutical entity will comprise a diversified portfolio of our leading durable brands across the Salix, International, dentistry, neurology, medical dermatology and generics, and aesthetic medical devices businesses; and
•Bausch + Lomb - a fully integrated, "pure play" eye health company built on the
iconic Bausch + Lomb brand and long history of innovation.
We believe the B+L Separation has created two highly attractive but dissimilar businesses. As independent entities, management believes that each company will be better positioned to individually focus on its core businesses to drive additional growth, more effectively allocate capital and better manage its respective capital needs. Further, the B+L Separation will allow us and the market to compare the operating results of each entity with other "pure play" peer companies. Although management believes the B+L Separation will unlock value, there can be no assurance that it will be successful in doing so. At the time of our announcement of the B+L Separation, we emphasized that it is important that the post-separation entities be well capitalized, with appropriate leverage and with access to additional capital, if and when needed, to provide each entity with the ability to independently allocate capital to areas that will strengthen their own competitive positions in their respective lines of business and position each entity for sustainable growth. Therefore, we see the appropriate capitalization and leverage of these businesses post-separation as a key to maximizing value across our portfolio of assets and, as such, it is a primary objective of our plan of separation. We believe the B+L Separation, if consummated, provides us with an attractive opportunity for liquidity to support the appropriate capitalization and leverage of the Bausch + Lomb entity and the remainder ofBausch Health , which we refer to as "Bausch Pharma" and which will assume a new name upon completion of the B+L Separation. Management will continue to thoughtfully evaluate all factors in connection with the B+L Separation. For additional details on the B+L Separation, see "Separation of the Bausch + Lomb Eye Health Business" in Note 2, "SIGNIFICANT ACCOUNTING POLICIES" to our unaudited interim Consolidated Financial Statements. 51 -------------------------------------------------------------------------------- See Item 1A. "Risk Factors - Risk Relating to the B+L Separation and the Solta IPO" of our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSEC and the CSA onFebruary 23, 2022 , for additional risks relating to the B+L Separation.
Focus on Core Businesses
To position ourselves to unlock the value we see in our individual businesses, we have sought to right-size our portfolio of assets and provide financial flexibility. In line with this focus on our core businesses, we have: (i) made measurable progress in effectively managing our capital structure, (ii) directed capital allocation to drive growth within these core businesses, (iii) divested assets to improve our capital structure and simplify our business, (iv) resolved certain of the Company's legacy litigation matters originating back to 2015 and prior, (v) increased our efforts to improve patient access and (vi) continued to invest in sustainable growth drivers to position us for long-term growth. We believe that these and other actions we have taken to transform our Company, have helped focus our operations, unlocked value across our product portfolios, improved our capital structure and mitigated certain risks associated with legacy litigation matters. We believe that these measures, along with our continued commitment to improving people's lives through our health products, help position us to unlock potential value across our portfolio of assets by separating our eye health and pharmaceutical businesses. Although management believes the B+L Separation will unlock additional value, there can be no assurance that it will be successful in doing so.
Effectively Managing Our Capital Structure
In connection with the B+L Separation, we have emphasized that it is important that the post-separation entities be well capitalized, with appropriate leverage and access to additional capital, if and when needed, to provide each entity with the ability to independently allocate capital to areas that will strengthen their own competitive positions in their respective lines of business and position each entity for sustainable growth. Therefore, we see the appropriate capitalization and leverage of these entities post-separation as a key to bringing out the maximum value across our portfolio of assets and, as such, it is a primary objective of our plan of separation.
Managing Our Capital Structure 2016 through 2021
In 2016, our executive team committed to improving our Company's capital structure and, since that time, we have been executing and continue to execute on that commitment. As a result of a series of debt repayments and transactions since making that commitment, the Company positioned itself to execute on the B+L IPO, while at the same time progressing toward providing the appropriate capitalization and leverage of the Company to effect the B+L Separation. Excluding the impact of the$1,210 million financing of the Securities Class Action Settlement (as defined in Note 18, "LEGAL PROCEEDINGS" in the accompanying unaudited interim Consolidated Financial Statements), we repaid (net of additional borrowings) approximately$10,000 million of long-term debt during the periodJanuary 1, 2016 throughDecember 31, 2021 using the net cash proceeds from divestitures of non-core assets, cash on hand and cash from operations, including from our focus on working capital management. See "U.S. Securities Litigation - Opt -Out Litigation" of Note 18, "LEGAL PROCEEDINGS" for additional details.
Managing Our Capital Structure in 2022
During 2022, we continue to effectively manage our capital structure by: (i) executing on our plan for the B+L Separation, including using the net proceeds from the B+L IPO which closed onMay 10, 2022 , to make repayments of debt, (ii) reducing our debt through open market repurchases, (iii) extending the maturities of debt through refinancing and (iv) completing an exchange offer which reduced the outstanding principal balance of our debt by$2,469 million by exchanging$5,594 million of aggregate principal value of existing unsecured senior notes (the "Existing Unsecured Senior Notes") for newly issued secured notes with an aggregate principal balance of$3,125 million (the "Exchange Offer"). As a result of these actions, described in additional detail below, during the nine months endedSeptember 30, 2022 , we have reduced the aggregate principal amount of our debt obligations by approximately$3,300 million as follows:
The B+L IPO, 2022 Notes Issuance and Credit Agreement Refinancing - In
connection with the B+L IPO, we completed a series of transactions in support of
our commitment to improve our liquidity, reduce our leverage and better
capitalize the two business entities post-separation. These transactions
included:
•OnFebruary 10, 2022 , the Company issued (the "2022 Notes Issuance")$1,000 million aggregate principal amount of 6.125% Senior Secured Notes dueFebruary 2027 (the "February 2027 Secured Notes"). 52 --------------------------------------------------------------------------------
•On
•The B+L IPO closed, with aggregate net proceeds (including from the partial
exercise of the over-allotment option by the underwriters), after deducting
underwriting commissions, of approximately
•The Company entered into the 2022 Amended Credit Agreement as defined and discussed in further detail below, under "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt". The 2022 Amended Credit Agreement consists of new term loans of$2,500 million and a revolving credit facility of$975 million . •Bausch + Lomb entered into the B+L Credit Agreement, as defined and discussed in further detail below under "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt". The B+L Credit Agreement provides for a five-year term loan facility in an initial principal amount of$2,500 million and also provides for a five-year revolving credit facility of$500 million . The net proceeds from these transactions, along with cash on hand, allowed us to: (i) repay certain amounts outstanding under our then existingJune 2025 Term Loan B Facility andNovember 2025 Term Loan B Facility (each as defined and discussed in further detail below under "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt"), (ii) replace our existing revolving credit facility which was due to mature in 2023, with revolving credit facilities that mature in 2027, (iii) redeem in full all of our then outstanding 6.125% Senior Unsecured Notes due 2025 (the "April 2025 Unsecured Notes") and (iv) replace our then remaining amounts outstanding under ourJune 2025 Term Loan B Facility andNovember 2025 Term Loan B Facility with term loan facilities that expire in 2027. Early Extinguishment of Debt - DuringJune 2022 , through a series of transactions we repurchased and retired, outstanding senior unsecured notes with an aggregate par value of$481 million in the open market for approximately$300 million using: (i) the net proceeds from the partial exercise of the over-allotment option in the B+L IPO by the underwriters, after deducting underwriting commissions, (ii) amounts available under our revolving credit facility and (iii) cash on hand. As a result of these transactions, we recognized a gain on the extinguishment of debt of approximately$176 million , net of write-offs of debt premiums, discounts and deferred issuance costs, representing the differences between the amounts paid to retire the senior unsecured notes and their carrying value. Exchange Offer - As discussed in further detail below under "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt", we made the strategic decision based on the fair value of our Senior Unsecured Notes to undertake the Exchange Offer inSeptember 2022 . We exchanged certain validly tendered existing senior unsecured notes, with an aggregate outstanding principal balance of approximately$5,594 million with maturities of 2025 through 2031 for newly issued senior secured notes, with an aggregate principal balance of approximately$3,125 million with maturities of 2028 and 2030. After fees and expenses, the Exchange Offer reduced the principal balances of our outstanding debt obligations by$2,469 million and extended the maturities of approximately$2,400 million of principal balances coming due during the years 2025 through 2027 to the years 2028 and 2030. We also recorded a net gain of$570 million as the future undiscounted cash flows of certain New Secured Notes were less than the net carrying value of the Existing Unsecured Senior Notes which were exchanged. As a result of: (i) the 2022 Notes Issuance and Credit Agreement Refinancing (as defined below under "-Senior Secured Credit Facilities under the 2022 Amended Credit Agreement"), (ii) the early extinguishment of debt, (iii) the Exchange Offer and (iv) other debt repayments (net of additional borrowings under our Revolving Credit Facility) we reduced the principal balances of our contractual debt obligations in 2022 by approximately$3,300 million . The contractual principal amount of our debt obligations as ofSeptember 30, 2022 andDecember 31, 2021 were as follows: September 30, December 31, (in millions) 2022 2021 Revolving Credit Facility$ 450 $ 285 Term Loan Facilities 2,469 3,823 B+L Term Loan Facility 2,494 - Senior Secured Notes 7,975 3,850 Senior Unsecured Notes 6,174 14,900 Other 12 12 Total long-term debt and other 19,574 22,870 Unamortized premiums, discounts and issuance costs 1,641 (216) Total long-term debt and other, net of premiums, discounts and issuance costs$ 21,215 $ 22,654 53
-------------------------------------------------------------------------------- These transactions also had the effect of reducing our cash debt service requirements over the next five years thereby providing us with additional flexibility as it relates to liquidity to operate. Prior to these transactions, our aggregate principal contractual debt repayment requirements through the year 2026 were approximately$5,425 million . As a result of these transactions, as ofSeptember 30, 2022 , we have reduced our estimated debt service requirements of principal and interest over the 12 months period endingSeptember 30, 2023 by approximately$65 million and reduced our aggregate principal contractual debt repayment requirements through the year 2026 to approximately$4,100 million . Maturities of our principal balances of debt obligations as ofSeptember 30, 2022 andDecember 31, 2021 , were as follows: (in millions) September 30, 2022 December 31, 2021 Remainder of 2022 $ 38 $ - 2023 150 285 2024 150 - 2025 2,859 9,723 2026 898 1,500 2027 6,926 2,250 2028 - 2031 8,553 9,112 Total debt obligations $ 19,574 $ 22,870 The following table presents the contractual principal and interest payments of the New Secured Notes. Contractual interest payments will be allocated to the reduction of the recorded premium and interest expense as presented below. Additionally, the amount of interest which reduces the premium will be reported as a Financing activity in the Consolidated Statement of Cash Flows. Remainder of (in millions) 2022 2023 2024 2025 2026 2027 Thereafter Total Principal Payments: 11.00% First Lien Secured Notes $ - $ -
$ - $ - $ - $ -
$ 1,774 14.00% Second Lien Secured Notes - - - - - - 352 352 9.00% Intermediate Holdco Secured Notes - - - - - - 999 999 - - - - - - 3,125 3,125 Interest Payments: 11.00% First Lien Secured Notes - 195 195 195 195 195 196 1,171 14.00% Second Lien Secured Notes - 52 49 49 49 49 148 396 9.00% Intermediate Holdco Secured Notes - 75 90 90 90 90 45 480 - 322 334 334 334 334 389 2,047 $ -$ 322 $ 334 $ 334 $ 334 $ 334 $ 3,514 $ 5,172 Interest payments recorded as: Interest expense $ -$ 43 $ 38 $ 36 $ 34 $ 32 $ 29 $ 212 Premium reduction - 279 296 298 300 302 360 1,835 $ -$ 322 $ 334 $ 334 $ 334 $ 334 $ 389 $ 2,047
We believe these transactions improve our overall capitalization and leverage.
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated Financial Statements and "Liquidity and Capital Resources: Long-term Debt" below for additional discussion of these matters. Cash requirements for future debt repayments including interest can be found in "Management's Discussion and Analysis - Off-Balance Sheet Arrangements and Contractual Obligations."
Continue to Manage our Capital Structure
We continue to monitor our capital structure and to evaluate other opportunities
to simplify our business and improve our capital structure, to give us the
ability to better focus on our core businesses and prepare us for
post-separation. Also, the Company regularly evaluates market conditions, its
liquidity profile and various financing alternatives for opportunities to
enhance its capital structure. If the Company determines that conditions are
favorable, the Company may refinance, repurchase or exchange existing debt or
issue additional debt, equity or equity-linked securities.
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Direct Capital Allocation to Drive Growth Within Our Core Businesses
Our capital allocation is driven by our long-term growth strategies. We have made strategic investments in our core businesses in order to support recent revenue growth and prepare for additional growth opportunities which we plan to capitalize on for our core businesses. We have been aggressively allocating resources to our core businesses globally through: (i) R&D investment, (ii) strategic licensing agreements and (iii) strategic investments in our infrastructure. We believe that the outcome of this process will allow us to better drive value in our product portfolio and generate operational efficiencies.
We search for new product opportunities through internal development and
strategic licensing agreements, that, if successful, will allow us to leverage
our commercial footprint, particularly our sales force, and supplement our
existing product portfolio and address specific unmet needs in the market.
Our internal R&D organization focuses on the development of products through clinical trials. As ofDecember 31, 2021 , approximately 1,300 dedicated R&D and quality assurance employees in 25 R&D facilities were involved in our R&D efforts internally.
As of
pipeline. Certain core internal R&D projects that have received a significant
portion of our R&D investment in current and prior periods are listed below.
Gastrointestinal
•Rifaximin - Top line results from a Phase 2 study for the treatment of overt hepatic encephalopathy with a new formulation (SSD IR) of rifaximin showed a treatment benefit. Patients receiving 40 mg twice daily showed a statistically significant separation from placebo. The top line results from this Phase 2 study and other clinical data of SSD in cirrhotic patients will help inform further research on potential new indications for rifaximin. A Phase 3 study has commenced (RED-C) with patients actively enrolling for the prevention of the first episode of Overt Hepatic Encephalopathy. •Rifaximin - Rifaximin recently received orphan drug designation for sickle cell disease. A phase 2 study with novel dosage formulation is currently enrolling patients for the treatment of sickle cell disease.
•Rifaximin - Development of a fit for purpose Patient Reported Outcomes tool for
small intestinal bacterial overgrowth, or "SIBO", is continuing in 2022.
•Rifaximin - We have entered into an agreement withCedars Sinai Medical Center to evaluate a new formulation of rifaximin for the treatment of IBS-D. Two preclinical studies have been completed. A Clinical Proof of Concept study that was paused due to COVID-19 pandemic related factors, has recommenced and is fully enrolled. Based on recent FDA comments datedFebruary 10, 2022 , the program was being assessed and related timelines reviewed and upon further review of the applicable timelines, the Company expects to terminate this program. •Envive™ - InOctober 2020 , we launched, on a limited basis, a probiotic supplement that was developed to address gastrointestinal disturbances. InApril 2021 , we expanded the launch to additional territories in theU.S.
•Amiselimod (S1P modulator) - We commenced a Phase 2 study during the first half
of 2021 to evaluate Amiselimod (S1P modulator) for the treatment of mild to
moderate ulcerative colitis.
Dermatology
•Arazlo® (tazarotene) Lotion, 0.045% - InJune 2020 , we launched this acne product containing lower concentration of tazarotene in a lotion form to help reduce irritation while maintaining efficacy.
•Internal Development Project ("IDP") 120 - An acne product with a fixed
combination of mutually incompatible ingredients: benzoyl peroxide and
tretinoin. Phase 3 clinical studies have been completed and met the primary
endpoints. We are currently evaluating next steps for this project.
•IDP-126 - An acne product with a fixed combination of benzoyl peroxide, clindamycin phosphate and adapalene. Phase 3 clinical studies initiated inDecember 2019 were paused due to COVID-19 pandemic related factors, but resumed inJune 2020 . Both Phase 3 studies have been completed and have met their primary endpoints. A comparative bridging safety and efficacy study was delayed until 2021 due to COVID-19. The bridging study has completed enrollment inJuly 2022 . We anticipate filing a New Drug Application ("NDA") in the fourth quarter of 2022. 55
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•Clear + Brilliant® Touch - Next generation Clear + Brilliant® laser that is designed to deliver a customized and more comprehensive treatment protocol by providing patients of all ages and skin types the benefits of two wavelengths. This product was launched in theU.S. inMarch 2021 .
Bausch + Lomb
•SiHy Daily - A silicone hydrogel daily disposable contact lens designed to provide clear vision throughout the day. InSeptember 2018 , we launchedSiHy Daily inJapan under the branded name AQUALOX™ ONE DAY. InAugust 2020 , we launchedSiHy Daily in theU.S. under the branded name Bausch + Lomb INFUSE® SiHy Daily Disposable contact lens. In the fourth quarter of 2020,SiHy Daily was launched inAustralia ,Hong Kong andCanada under the branded name Bausch + Lomb Ultra® ONE DAY.SiHy Daily has also received regulatory approval inChina ,New Zealand ,Japan ,South Korea ,Europe ,Singapore andMalaysia , where it will be branded as Bausch + Lomb Ultra® ONE DAY, and in the second quarter of 2021, we launchedSiHy Daily inSouth Korea andSingapore as Bausch + Lomb Ultra® ONE DAY. •LUMIFY® (brimonidine tartrate ophthalmic solution, 0.025%) - An OTC eye drop developed as an ocular redness reliever. We launched this product in theU.S. inMay 2018 and inCanada inJune 2022 . Currently, we have several new line formulations under development. The first Phase 3 study in support of these line extensions has initiated. Additional studies have commenced duringOctober 2022 . •New Ophthalmic Viscosurgical Device ("OVD") product - A formulation to protect corneal endothelium during phacoemulsification process during a cataract surgery and to help chamber maintenance and lubrication during IOL delivery. A clinical study report was completed for the cohesive OVD product (StableVisc™) during the second quarter of 2022. FDA approval is expected in the fourth quarter of 2022 and launch is expected in the first quarter of 2023. In addition, inMarch 2021 , we received Premarket Approval from the FDA for Clearvisc™ dispersive OVD, which we launched in theU.S. inJune 2021 . •Bausch + Lomb is expanding its portfolio of premium IOLs built on the enVista® platform with Monofocal Plus, EDOF and Trifocal optical designs for presbyopia correction. Bausch + Lomb expects that they will be commercialized together with a new preloaded inserter with two options: non-Toric, as well as Toric for astigmatism patients. Bausch + Lomb anticipates launching Monofocal Plus, Trifocal and EDOF optical designs for presbyopia in theU.S. in 2023, 2024 and 2025/2026, respectively. •Renu® Advanced Multi-Purpose Solution ("MPS") - Contains a triple disinfectant system that kills 99.9% of germs tested, and has a dual surfactant system that provides up to 20 hours of moisture. Renu® Advanced MPS is FDA cleared with indications for use to condition, clean, remove protein, disinfect, rinse and store soft contact lenses including those composed of silicone hydrogels. Prior to 2022, Renu® Advanced MPS was launched inIndia ,Mexico ,Korea ,Turkey andGreece and gained regulatory approvals inIndonesia ,Malaysia ,Singapore , theEuropean Union ,Belarus andChina . In 2022, Renu® Advanced MPS was launched inTaiwan ,Czech Republic ,Israel ,Poland ,Slovakia ,China ,Argentina , Columbia,Ecuador andPeru . We anticipate launches inSlovenia , other parts ofEurope and the Nordic regions.
Strategic Licensing Agreements
To supplement our internal R&D initiatives and to build-out and refresh our
product portfolio, we also search for opportunities to augment our pipeline
through arrangements that allow us to gain access to unique products and
investigational treatments, by strategically aligning ourselves with other
innovative product solutions.
In the normal course of business, the Company will enter into select licensing and collaborative agreements for the commercialization and/or development of unique products. These products are sometimes investigational treatments in early stage development that target unique conditions. The ultimate outcome, including whether the product will be: (i) fully developed, (ii) approved by the FDA or other regulators, (iii) covered by third-party payors or (iv) profitable for distribution, is highly uncertain. Under certain agreements, the Company may be required to make payments contingent upon the achievement of specific developmental, regulatory, or commercial milestones. InOctober 2019 , we acquired an exclusive license from Clearside Biomedical, Inc. ("Clearside") for the commercialization and development of Xipere® (triamcinolone acetonide suprachoroidal injectable suspension) in theU.S. andCanada . Xipere® is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside's proprietary SCS Microinjector®. InOctober 2021 , the FDA approved Xipere® for suprachoroidal use for the treatment of macular edema associated with uveitis. We launched Xipere® in theU.S. in the first quarter of 2022. 56 -------------------------------------------------------------------------------- InApril 2019 , we entered into an exclusive licensing agreement withMitsubishi Tanabe Pharma Corporation to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate receptor that plays a role in autoimmune diseases, such as inflammatory bowel disease and ulcerative colitis. We have completed a thorough QTC study, which evaluated the cardiac safety profile of the compound. Topline results were positive and we commenced a Phase 2 study in the first half of 2021.
Divest Assets to Improve Our Capital Structure and Simplify Our Business
In order to better focus on our core businesses, we continue to evaluate opportunities to simplify our operations and improve our capital structure, including divesting non-core assets in order to narrow the Company's activities to our core businesses where we believe we have an existing and sustainable competitive edge and the ability to generate operational efficiencies. To date, we received approximately$4,100 million in net proceeds from these divestitures, which includes the sale ofAmoun Pharmaceutical Company S.A.E . ("Amoun") discussed below. OnJuly 26, 2021 , we completed the sale of Amoun for total gross consideration of approximately$740 million , subject to certain adjustments (the "Amoun Sale"). Amoun manufactures, markets and distributes branded generics of human and animal health products. The Amoun business was part of the International segment (previously included within the former Bausch + Lomb/International segment). Revenues associated with Amoun were$157 million for the period ofJanuary 1, 2021 throughJuly 26, 2021 . OnJuly 30, 2021 andAugust 3, 2021 , the Company made aggregate payments of$600 million , to repay$469 million of itsJune 2025 Term Loan B Facility and$131 million of itsNovember 2025 Term Loan B Facility (each as defined below), using the proceeds from the Amoun Sale and cash on hand. We will continue to consider further dispositions of various assets in line with this strategy. While we anticipate that any future divestiture activities will be on non-core assets, we will consider dispositions in core areas that we believe represent attractive opportunities for the Company. See Note 4, "LICENSING AGREEMENTS AND DIVESTITURE" to our unaudited interim Consolidated Financial Statements for additional information.
Resolved Legacy Legal Matters
In 2020 and 2021, we resolved certain of the Company's legacy legal matters originating back to 2015 and prior, including settling theU.S. Securities Litigation (see "U.S. Securities Litigation - Opt -Out Litigation" of Note 18, "LEGAL PROCEEDINGS"). The Securities Class Action Settlement resolves the most significant of the Company's remaining legacy legal matters and eliminates a material uncertainty regarding the Company.
Improve Patient Access
Improving patient access to our products, as well as making them more
affordable, is a key element of our business strategy.
Patient Access and Pricing Committee - OurPatient Access and Pricing Committee is responsible for setting, changing and monitoring the pricing of our products and evaluating contract arrangements that determine the placement of our products on drug formularies.The Patient Access and Pricing Committee considers new to market product pricing, price changes and their impact across channels on patient accessibility and affordability. Since its inception in 2016, thePatient Access and Pricing Committee has limited the average annual price increase for our branded prescription pharmaceutical products to single digits. Future pricing changes and programs could affect the average realized pricing for our products and may have a significant impact on our revenues and profits.Bausch Health Patient Assistance Program - In the face of the COVID-19 pandemic, some people have financial obstacles that keep them from obtaining and continuing their prescribed treatments. We are committed to supporting patients who have lost employment health benefits due to the COVID-19 pandemic, and because it is essential that our patients continue their prescribed treatments, we are proud to offer certain of our prescription medicines through ourBausch Health Patient Assistance Program . The purpose of theBausch Health Patient Assistance Program is to provide eligible unemployed patients in theU.S. , who meet stated qualifications and have lost their health insurance due to the COVID-19 pandemic, with certain of our prescription products where their financial circumstances or insurance status would otherwise interfere with their ability to access such products. If approved, patients receive theirBausch Health prescription product(s) at no cost to them for up to one year, and may be able to reapply to the program annually if they continue to meet eligibility requirements and have a valid prescription. Cash-pay Prescription Program - InFebruary 2019 , we launched Dermatology.com, a cash-pay product acquisition program offering certain brandedOrtho Dermatologics products directly to patients. InMarch 2020 , the name Dermatology.com was removed as the cash-pay product program name, with the name Dermatology.com limited to only online usage, including future digital teledermatology and e-commerce offerings. The cash-pay program is designed to address the affordability and availability of certain branded dermatology products, when insurers and pharmacy benefit 57 --------------------------------------------------------------------------------
managers are no longer offering those branded prescription pharmaceutical
products under their designated pharmacy benefit offerings.
Walgreens Fulfillment Arrangements - In the beginning of 2016, we launched a brand fulfillment arrangement withWalgreen Co. ("Walgreens"). Under the terms of the brand fulfillment arrangement, as amended inJuly 2019 , we made certain dermatology and ophthalmology products available to eligible patients through patient access and co-pay assistance programs at WalgreensU.S. retail pharmacy locations, as well as participating independent retail pharmacies.
Invest in Sustainable Growth Drivers to Position us for Long-Term Growth
We are constantly challenged by the changing dynamics of our industry to
innovate and bring new products to market. We have divested certain businesses
where we saw limited growth opportunities, so that we can be more aggressive in
redirecting our R&D spend and other corporate investments to innovate within our
core businesses where we believe we can be most profitable and where we aim to
be an industry leader.
We believe that we have a well-established product portfolio that is diversified
within our core businesses and provides a sustainable revenue stream to fund our
operations. However, our future success is also dependent upon our ability to
continually refresh our pipeline, to provide a rotation of product launches that
meet new and changing demands and replace other products that have lost
momentum. We believe we have a robust pipeline that not only provides for the
next generation of our existing products, but is also poised to bring new
products to market.
Leveraging our Salix Infrastructure - We strongly believe in our GI product
portfolio and we have implemented initiatives, including increasing our
marketing presence and identifying additional opportunities outside our existing
GI portfolio, to further capitalize on the value of the infrastructure we have
built around these products to extend our market share.
In the first quarter of 2017, we hired approximately 250 trained and experienced
sales force representatives and managers to create, bolster and sustain deep
relationships with primary care physicians ("PCP"). With approximately 70% of
IBS-D patients initially presenting symptoms to a PCP, we continue to believe
that the dedicated PCP sales force is well positioned to reach more patients in
need of IBS-D treatment.
Our sales force has been successful in delivering consistent growth in demand
for our GI products, demonstrated by our growth in Salix revenues of 32% when
comparing 2021 to 2017. We continue to seek ways to bring out further value
through leveraging our existing sales force including the following
opportunities:
Trulance® Acquisition - In March 2019 , we completed the acquisition of certain
assets of Synergy Pharmaceuticals Inc. ("Synergy"), whereby we acquired the
worldwide rights to the Trulance® product, a once-daily tablet for adults with
chronic idiopathic constipation, or CIC and irritable bowel syndrome with
constipation, or IBS-C. We believe that the Trulance® product complements our
existing Salix products and allows us to effectively leverage our existing GI
sales force. In order to drive growth of the Trulance® product, we have
increased the number of sales force representatives for the Trulance® product.
We believe this has been successful as Trulance® revenues were $77 million and
$74 million for the nine months ended September 30, 2022 and 2021, respectively.
Licensing Arrangement - As previously discussed, in April 2019 , we entered into
a licensing agreement to develop and commercialize MT-1303 (amiselimod), a
late-stage oral compound that targets the sphingosine 1-phosphate receptor that
plays a role in autoimmune diseases, such as inflammatory bowel disease and
ulcerative colitis. This license presents a unique developmental opportunity to
address unmet needs of individuals suffering with certain GI and liver diseases
and, if developed and approval is obtained from the FDA, will allow us to
further utilize our existing sales force and infrastructure to extend our market
share in the future and create value.
Investment in Next Generation Formulations - Revenues from our Xifaxan® product
line increased approximately 11%, 2% and 22% in 2021, 2020 and 2019,
respectively. For the nine months ended September 30, 2022 and 2021, Xifaxan®
product revenues were $1,216 million and $1,194 million , respectively, an
increase of $22 million or 2%. In order to extend growth in Xifaxan®, we
continue to directly invest in next generation formulations of Xifaxan® and
rifaximin, the principal semi-synthetic antibiotic used in our Xifaxan® product.
We believe that the acquisition and licensing opportunities discussed above will
be accretive to our business by providing us access to products and
investigational compounds that are a natural pairing to our Xifaxan® business,
allowing us to effectively leverage our existing infrastructure and sales force.
We believe these opportunities, coupled with our investment in next generation
formulations, will allow our GI franchise to continue to further extend market
share.
Investment in Our Solta Aesthetic Medical Device Business - Next generation
Thermage FLX®, a fourth-generation non-invasive treatment option using a radio
frequency platform designed to optimize key functional characteristics and
improve patient outcomes, has been on sale since 2017 in the U.S. , Hong Kong ,
Japan , Korea , Taiwan , Philippines ,
58
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Singapore , Indonesia , Malaysia , China , Thailand , Vietnam , Australia and various
parts of Europe as part of our Solta aesthetic medical devices portfolio. We
plan to continue to expand into other regions, paced by country-specific
regulatory registrations. Next generation Thermage FLX® revenues were
$154 million and $142 million for the years 2021 and 2020, respectively.
Consistent with our business strategy to continually update and improve our
technology, in 2021, we launched, in the U.S. , our next generation Clear +
Brilliant® Touch system which is designed to deliver a customized and more
comprehensive treatment protocol by providing patients of all ages and skin
types the benefits of two wavelengths. The launch of our next generation Clear +
Brilliant® Touch system in the U.S. is expected to serve as a foundation for
future launches in Asia and Europe .
Reposition the Ortho Dermatologics Business to Generate Additional Value - Our
Ortho Dermatologics business continues to work towards improving the treatment
options for medical dermatology patients needing topical acne and psoriasis
products. We continue to explore additional strategic e-commerce and partnership
expansion opportunities which can enable increased accessibility for patients
and we continue to invest in our on-market products and evaluate various
opportunities for our key medical dermatology pipeline products.
In support of the complete dermatology portfolio, we continue to take a number
of actions that we believe will help our efforts to stabilize our dermatology
business. These actions include: (i) building on our legacy brands to improve
and meet today's physician relevance and customer service, (ii) making key
investments in our core medical device and dermatological products portfolios,
(iii) optimizing our go to market strategy by building on our relationships with
prescribers of our products to balance our sales portfolio with the business'
profitability, (iv) refocusing our operational and promotional resources and (v)
improving patient access to our Ortho Dermatologics products through our
cash-pay prescription program previously discussed. In addition, we made
significant investments to build out our psoriasis and acne portfolios as
follows:
Psoriasis - In response to the increasing number of reported cases of psoriasis
in the U.S. , we launched Duobrii® in June 2019 and launched Bryhali® in November
2018 , which align well with our topical portfolio of psoriasis treatments.
Although we continue to support a diverse portfolio of topical and injectable
biologics, in order to provide a diverse choice of psoriasis treatments to
doctors and patients, we believe some patients prefer topical products as an
alternative to injectable biologics.
Acne - In support of our established acne product portfolio, we have developed
and launched several products, which include Arazlo® (tazarotene) Lotion
(launched in the U.S. in June 2020 ), Altreno® (launched in the U.S. in October
2018 ), the first lotion (rather than a gel or cream) product containing
tretinoin for the treatment of acne, and Retin-A Micro® 0.06% (launched in the
U.S. in January 2018 ). As previously discussed, we also have a unique acne
project in our pipeline (IDP-126) that, if approved by the FDA, we believe will
further innovate and advance the treatment of acne.
Invest in our Bausch + Lomb Business - As a fully integrated eye health business
with a legacy of over 165 years, Bausch + Lomb has an established line of
contact lenses, intraocular lenses and other medical devices, surgical systems
and devices, vitamin and mineral supplements, lens care products, prescription
eye-medications and other consumer products that positions us to compete in all
areas of the eye health market. As part of our global Bausch + Lomb business
strategy, we continually look for key trends in the eye health market to meet
changing consumer/patient needs and identify areas for investment to extend our
market share through new launches and effective pricing.
For instance, there is an increasing rate of myopia, and importantly, myopia is
a potential risk factor for glaucoma, macular degeneration and retinal
detachment. We continue to see increased demand for new eye health products that
address conditions brought on by factors such as increased screen time, lack of
outdoor activities and academic pressures, as well as conditions brought on by
an aging population (for example, as more and more baby-boomers in the U.S. are
reaching the age of 65). To extend our market share in eye health, we
continually seek to identify new products tailored to address these key trends
for development internally with our own R&D team to generate organic growth.
Recent product launches include Biotrue® ONEday daily disposable contact lenses,
the next generation of Bausch + Lomb ULTRA® contact lenses, SiHy Daily contact
lenses (branded as AQUALOX™ ONE DAY in Japan , Bausch + Lomb INFUSE® SiHy Daily
Disposable in the U.S. and Bausch + Lomb Ultra® ONE DAY in Australia , Hong Kong ,
Canada and South Korea and Singapore ), Lumify® (an eye redness treatment),
Vyzulta® (a pressure lowering eye drop for patients with angle glaucoma or
ocular hypertension), Ocuvite® Eye Performance (vitamins to protect the eye from
stressors such as sunlight and blue light emitted from digital devices) and
SimplifEYE® (preloaded intraocular lens injector platform for enVista
intraocular lens).
We also license selective molecules or technology in leveraging our own R&D
expertise through development, as well as seek out external product development
opportunities. As previously discussed, we acquired a global exclusive license
for a myopia control contact lens design developed by BHVI, which we plan to
pair with our leading contact lens technologies to develop potential contact
lens treatments designed to slow the progression of myopia in children, and
exclusive licenses for the commercialization and development in the U.S. and
Canada of: (i) a microdose formulation of atropine ophthalmic solution, which is
being investigated for the reduction of pediatric myopia progression in children
ages 3-12; (ii) Xipere®
59
-------------------------------------------------------------------------------- which was approved by the FDA inOctober 2021 and launched in the first quarter of 2022, and is the first treatment available in theU.S. that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis; and (iii) NOV03, an investigational drug with a novel mechanism of action to treat DED associated with MGD which has demonstrated statistically significant topline data in two Phase 3 studies. We also acquired theU.S. rights to EM-100, which was launched inFebruary 2021 as Alaway® Preservative-Free and is the first OTC preservative-free formulation eye drop for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, and dander in adults and children 3 years of age and older. We believe investments in these investigational treatments, if approved by the FDA, will complement, and help build upon our strong portfolio of integrated eye health products. As previously discussed, we have also made strategic investments in our infrastructure, the most significant of which were at ourWaterford facility inIreland to meet the forecasted demand for our Biotrue® ONEday lenses, ourRochester facility inNew York to address the expected global demand for our Bausch + Lomb ULTRA® contact lens and ourLynchburg facility inVirginia to be our main point of distribution for medical devices in theU.S. During late 2018, we began investing in additional expansion projects at theWaterford andRochester facilities in order to address the expected global demand for ourSiHy Daily disposable contact lenses, which we launched inJapan inSeptember 2018 , under the branded name AQUALOX™ ONE DAY, in theU.S. inAugust 2020 , under the branded name Bausch + Lomb INFUSE® SiHy Daily Disposable contact lens, and inAustralia ,Hong Kong andCanada in the fourth quarter of 2020 and inSouth Korea andSingapore in the second quarter of 2021, under the branded name Bausch + Lomb Ultra® ONE DAY.
We believe our recent product launches, licensing arrangements and the
investments in our
growth potential we see in our Bausch + Lomb products and our eye health
business and that these investments will position us to further extend our
market share in the eye health market.
Business Trends
In addition to the actions previously outlined, the events described below have
affected and may affect our business trends. The matters discussed in this
section contain forward-looking statements. Please see "Forward-Looking
Statements" at the end of Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations for additional information.
Russia-Ukraine War
InFebruary 2022 ,Russia invadedUkraine . As military activity and sanctions againstRussia ,Belarus and specific areas ofUkraine have continued, the war has increasingly affected economic and global financial markets and exacerbated ongoing economic challenges, including issues such as rising inflation and global supply-chain disruption. Our revenues attributable toRussia for the nine months endedSeptember 30, 2022 and 2021 were$122 million and$106 million , respectively. Our revenues attributable toUkraine for the nine months endedSeptember 30, 2022 and 2021 were$7 million and$9 million , respectively. Our revenues attributable toBelarus for the nine months endedSeptember 30, 2022 and 2021 were$6 million in each period. As the geopolitical situation inEastern Europe continues to intensify, political events and sanctions are continually changing, and we continue to assess the impact that theRussia -Ukraine war has had and will have on our businesses. These impacts may include but are not limited to: (i) interruptions or stoppage of production, (ii) damage or loss of inventories, (iii) supply-chain and product distribution disruptions inEastern Europe , (iv) volatility in commodity prices and currencies, (v) disruption in banking systems and capital markets, (vi) reductions in sales and earnings of business in affected areas, (vii) increased costs and (viii) cyberattacks. To date, these challenges have not yet had a material impact on our operations; however, we anticipate that the ongoing conflict in this region and the sanctions and other actions by the global community in response will continue to hinder our ability to conduct business with customers and vendors in this region. For example, we expect to experience further disruption and delays in the supply of our products to our customers inRussia ,Belarus andUkraine . We may also experience further decreased demand for our products in these countries as a result of the conflict and invasion. In addition, we expect to experience difficulties in collecting receivables from such customers. If we continue to be hampered in our ability to conduct business with new or existing customers and vendors in this region, our business, and operations, including our revenues, profitability and cash flows, could be adversely impacted. Furthermore, if the sanctions and other retaliatory measures imposed by the global community change, we may be required to cease or suspend our operations in the region or, should the conflict worsen, we may voluntarily elect to do so. We cannot provide assurance that current sanctions or potential future changes in these sanctions or other measures will not have a material impact on our operations inRussia ,Belarus andUkraine . The disruption to or suspension of our business and operations inRussia ,Belarus andUkraine may have a material adverse impact on our business, financial condition, cash flows and results of operations. We will continue to monitor the impacts of theRussia -Ukraine war on macroeconomic conditions and continually assess the effect these matters may have on our businesses. 60 --------------------------------------------------------------------------------
Impacts of COVID-19 Pandemic
The unprecedented nature of the COVID-19 pandemic has had, and continues to have, an adverse impact on the global economy. The COVID-19 pandemic and the reactions of governments, private sector participants and the public in an effort to contain the spread of the COVID-19 virus and/or address its impacts have had significant direct and indirect effects on businesses and commerce. This includes, but is not limited to, disruption to supply chains, employee base and transactional activity, facilities closures and production suspensions. Our revenues were most negatively impacted during our second quarter of 2020 by certain social restrictions and other precautionary measures taken in response to the COVID-19 pandemic. However, as governments began lifting social restrictions, allowing offices of certain health care providers to reopen and certain surgeries and elective medical procedures to proceed, the negative trend in the revenues of certain businesses began to level off and stabilize prior to our third quarter of 2020. After the launch of effective vaccines inDecember 2020 , infection rates began to decline, signaling the beginning of a recovery from the COVID-19 pandemic. Our revenues gradually returned to pre-pandemic levels for many of our businesses and geographies throughout 2021. However, in some regions, includingChina (as further described below), we continue to experience negative impacts of the COVID-19 pandemic on our business in those regions. The rates of recovery for each business will vary by geography and will be dependent upon, among other things, the availability and effectiveness of vaccines for the COVID-19 virus and variant and subvariant strains thereof, government responses, rates of economic recovery, precautionary measures taken by patients and customers, the rate at which remaining social restrictions are lifted and, once lifted, the presumption that social restrictions will not be materially reenacted in the event of a resurgence of the virus or variant and subvariant strains thereof and other actions taken in response to the COVID-19 pandemic. The outbreak of the omicron variant inChina in 2022 resulted in government enforced lockdowns and other social restrictions, which impacted our ability to conduct business as usual in certain regions inChina , particularlyShanghai . The lockdowns inChina have impacted the demand for certain products, particularly our consumer, vision care and Solta products, as shelter in place orders limit the demand and need for the use of contact lenses and related products as well as for aesthetic medical treatments. Our revenues inChina for the nine months endedSeptember 30, 2022 and 2021 were$293 million and$350 million , respectively, a decrease of$57 million and, in part, reflects the impact of the surge of the omicron variant inChina . Additionally, government enforced lockdowns have caused certain businesses to suspend operations, creating distribution and other logistic issues for the distribution of our products and the sourcing for a limited number of raw materials. Through the date of this filing, we have dealt with these issues inChina with only a minimal impact on our manufacturing and distribution processes. However, as the impacts of global reaction to the COVID-19 pandemic remains a fluid situation, we continue to monitor the impacts on our businesses of the COVID-19 virus and variant and subvariant strains thereof in order to timely address new issues if and when they arise. For a further discussion of these and other COVID-19 related risks, see Item 1A. "Risk Factors - Risk Relating to COVID-19" of our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSEC and the CSA onFebruary 23, 2022 . Inflation Reduction Act OnAugust 16, 2022 ,President Biden signed the Inflation Reduction Act into law, which includes implementation of a new alternative minimum tax, an excise tax on stock buybacks and significant tax incentives for energy and climate initiatives, among other provisions. The corporate alternative minimum tax ("CAMT") imposes a minimum tax on the adjusted financial statement income ("AFSI") for "applicable corporations" with average annual AFSI over a three-year period in excess of$1 billion . A corporation that is a member of a foreign-parented multinational group, as defined, must include the AFSI (with certain modifications) of all members of the group in applying the$1 billion test, but would only be subject to CAMT if the three-year average AFSI of itsU.S. members, US trades or business of foreign group members that are not subsidiaries ofU.S. members, and foreign subsidiaries ofU.S. members exceeds$100 million . We currently do not believe this will have a significant impact on our tax results, but will continue to evaluate the law and its provisions.
Global Minimum Corporate Tax Rate
OnOctober 8, 2021 , theOrganisation for Economic Co-operation and Development ("OECD")/G20 inclusive framework on Base Erosion and Profit Shifting (the "Inclusive Framework") published a statement updating and finalizing the key components of a two-pillar plan on global tax reform originally agreed onJuly 1, 2021 , and a timetable for implementation by 2023. The timetable for implementation has since been extended to 2024. The Inclusive Framework plan has now been agreed to by 141OECD members, including several countries which did not agree to the initial plan. Under pillar one, a portion of the residual profits of multinational businesses with global turnover above €20 billion and a profit margin above 10% will be allocated to market countries where such allocated profits would be taxed. Under pillar two, the Inclusive Framework has agreed on a global minimum corporate tax rate of 15% for companies with revenue above €750 million, calculated on a country-by-country basis. OnOctober 30, 2021 , theG20 formally endorsed the new global minimum 61 -------------------------------------------------------------------------------- corporate tax rate rules. The Inclusive Framework agreement must now be implemented by the OECD Members who have agreed to the plan, effective in 2024. OnDecember 20, 2021 , theOECD published model rules to implement the pillar two rules, which are generally consistent with the agreement reached by the Inclusive Framework inOctober 2021 . Some further guidance on the plan and the related rules has been published, with additional guidance expected to be published in 2023. We will continue to monitor the implementation of the Inclusive Framework agreement by the countries in which we operate. While we are unable to predict when and how the Inclusive Framework agreement will be enacted into law in these countries, and it is possible that the implementation of the Inclusive Framework agreement, including the global minimum corporate tax rate could have a material effect on our liability for corporate taxes and our consolidated effective tax rate.
Health Care Reform
TheU.S. federal and state governments continue to propose and pass legislation designed to regulate the health care industry. InMarch 2010 , the Patient Protection and Affordable Care Act (the "ACA") was enacted in theU.S. The ACA contains several provisions that impact our business, including: (i) an increase in the minimum Medicaid rebate to states participating in the Medicaid program, (ii) the extension of the Medicaid rebates to Managed Care Organizations that dispense drugs to Medicaid beneficiaries, (iii) the expansion of the 340(B)Public Health Services drug pricing program, which provides outpatient drugs at reduced rates, to include additional hospitals, clinics and health care centers and (iv) a fee payable to the federal government based on our prior-calendar-year share relative to other companies of branded prescription drug sales to specified government programs. In addition, in 2013, federal subsidies began to be phased in for brand-name prescription drugs filled in the Medicare Part D coverage gap. The ACA also included provisions designed to increase the number of Americans covered by health insurance. In 2014, the ACA's private health insurance exchanges began to operate. The ACA also allows states to expand Medicaid coverage with most of the expansion's cost paid for by the federal government. For 2021 and 2020, we incurred costs of$13 million and$21 million , respectively, related to the annual fee assessed on prescription drug manufacturers and importers that sell branded prescription drugs to specifiedU.S. government programs (e.g., Medicare and Medicaid). For 2021 and 2020, we also incurred costs of$94 million and$131 million , respectively, on Medicare Part D utilization incurred by beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the "donut hole"). In 2018, we faced uncertainties due to federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the ACA. However, we believe there is low likelihood of repeal of the ACA, given the failure of theSenate's multiple attempts to repeal various combinations of ACA provisions and the change in theU.S. Presidential administration. There is no assurance that any replacement or administrative modifications of the ACA will not adversely affect our business and financial results, particularly if the replacing legislation reduces incentives for employer-sponsored insurance coverage, and we cannot predict how future federal or state legislative or administrative changes relating to the reform will affect our business. In 2019, theU.S. Department of Health and Human Services announced a preliminary plan to allow for the importation of certain lower-cost drugs fromCanada . The preliminary plan excludes insulin, biological drugs, controlled substances and intravenous drugs. The preliminary plan relies on individual states to develop proposals for safe importation of those drugs fromCanada and submit those proposals to the federal government for approval. Although the preliminary plan has some support from the prior administration, at this time, studies to evaluate the related costs and benefits, evaluate the reasonableness of the logistics, and measure the public reaction of such a plan have not been performed. While we do not believe this will have a significant impact on our future cash flows, we cannot provide assurance as to the effect or impact of such a plan. In 2019, theGovernment of Canada (Health Canada ) published in theCanada Gazette the new pricing regulation for patented drugs. These regulations were scheduled to become effective onJuly 1, 2021 , but have been delayed untilJuly 1, 2022 . The new regulations will, among other things, change the mechanics of establishing the pricing for products submitted for approval afterAugust 21, 2019 and the number and composition of reference countries used to determine if a drug's price is excessive. While we do not believe this will have a significant impact on our future cash flows, as additional facts materialize, we cannot provide assurance as to the ultimate content, timing, effect or impact of such regulations. InJuly 2020 , formerU.S. PresidentDonald Trump signed four Executive Orders related to drug pricing, including orders addressing: (i) Part D rebate reform, (ii) the provision of deeply discounted insulin and/or an EpiPen to patients of Federally Qualified Health Centers, (iii) drug importation fromCanada and (iv) most favored nation pricing for Medicare. InNovember 2020 , formerU.S. PresidentDonald Trump announced the Most Favored Nation Model for Medicare Part B Payment which was to be implemented by theCenters for Medicare & Medicaid Services Innovation onJanuary 1, 2021 ; however, it has not been implemented, as it is currently being challenged in court. It is also uncertain whether the Biden administration intends to reverse these measures or adopt similar policy initiatives. 62
-------------------------------------------------------------------------------- InDecember 2020 , as part of a series of drug pricing-related rules issued by theTrump Administration , theCenter for Medicare & Medicaid Services issued a Final Rule that makes significant modifications to the Medicaid Drug Rebate Program regulations in several areas, including with respect to the definition of key terms "line extension" and "new formulation" and best price reporting relating to certain value-based purchasing arrangements (which took effect onJanuary 1, 2022 ) and the price reporting treatment of manufacturer-sponsored patient benefit programs (which take effect onJanuary 1, 2023 ).
In
One of the provisions included within the American Rescue Plan Act of 2021
eliminated the Maximum Rebate Amount for
Multiple Source drugs in the Medicaid Drug Rebate Program. We are currently
reviewing this legislation, the impact of which is uncertain at this time.
Adoption of legislation at the federal or state level could materially affect demand for, or pricing of, our products. Additionally,U.S. PresidentJoseph Biden and several members of the currentU.S. Congress have indicated that lowering drug prices is a legislative and political priority. Other legislative efforts relating to drug pricing have been enacted and others have been proposed at theU.S. federal and state levels. For instance, certain states have enacted legislation related to prescription drug pricing transparency. Several states have passed importation legislation andFlorida is working with theU.S. government to implement an importation program fromCanada . We also anticipate thatCongress , state legislatures and third-party payors may continue to review and assess alternative health care delivery and payment systems and may in the future propose and adopt legislation or policy changes or implementations affecting additional fundamental changes in the health care delivery system. We continually review newly enacted and proposedU.S. federal and state legislation, as well as proposed rulemaking and guidance published by theDepartment of Health and Human Services and the FDA; however, at this time, it is unclear the effect these matters may have on our businesses.
Certain of our products face the expiration of their patent or regulatory
exclusivity in 2022 or in later years, following which we anticipate generic
competition of these products. In addition, in certain cases, as a result of
negotiated settlements of some of our patent infringement proceedings against
generic competitors, we have granted licenses to such generic companies, which
will permit them to enter the market with their generic products prior to the
expiration of our applicable patent or regulatory exclusivity. Finally, for
certain of our products that lost patent or regulatory exclusivity in prior
years, we anticipate that generic competitors may launch in 2022 or in later
years. Following a loss of exclusivity ("LOE") of and/or generic competition for
a product, we would anticipate that product sales for such product would
decrease significantly shortly following the LOE or entry of a generic
competitor. Where we have the rights, we may elect to launch an authorized
generic ("AG") of such product (either ourselves or through a third-party) prior
to, upon or following generic entry, which may mitigate the anticipated decrease
in product sales; however, even with launch of an authorized generic, the
decline in product sales of such product would still be expected to be
significant, and the effect on our future revenues could be material.
A number of our products already face generic competition. Prior to and during
2021, in the U.S. , these products include, among others, Ammonul®, Apriso®,
Benzaclin®, Bepreve®, Bupap®, Cuprimine®, Demser®, Edecrin®, Elidel®, Glumetza®,
Istalol®, Isuprel®, Locoid® Lotion, Lotemax® Gel, Lotemax® Suspension,
Mephyton®, Migranal®, MoviPrep®, Nitropress®, Solodyn®, Syprine®, Timoptic® in
Ocudose®, Uceris® Tablet, Virazole®, Wellbutrin XL®, Xenazine®, Zegerid® and
Zovirax® cream. In Canada , these products include, among others, Glumetza®,
Wellbutrin® XL and Zovirax® ointment.
2021 LOE Branded Products - Branded products that began facing generic
competition in the U.S. during 2021 included Lotemax® Gel, Bepreve®, Clindagel®
and certain other products. These products accounted for less than 1% of our
total revenues in 2020. We believe the entry into the market of generic
competition generally would have an adverse impact on the volume and/or pricing
of the affected products, however we are unable to predict the magnitude or
timing of this impact.
2022 through 2026 LOE Branded Products - Based on current patent expiration
dates, settlement agreements and/or competitive information, we have identified
branded products that we believe could begin facing potential LOE and/or generic
competition in the U.S. during the years 2022 through 2026. These products and
year of expected LOE include, but are not limited to, Noritate® (2022),
Targretin® Gel (2022), Xerese® (2022) and certain other products that are
subject to settlement agreements which could impact their exclusivity during the
years 2022 through 2026. In aggregate, these products accounted for 2% of our
total revenues in 2021. These dates may change based on, among other things,
successful challenge to our patents, settlement of existing or future patent
litigation and at-risk generic launches. We believe the entry into the market of
generic competition generally would have an adverse impact on the volume and/or
pricing of the affected products, however we are unable to predict the magnitude
or timing of this impact.
63
-------------------------------------------------------------------------------- In addition, for a number of our products (including Xifaxan® 200mg and 550mg, Bryhali®, Duobrii®, Trulance®, Lumify® and Relistor® Injection in theU.S. and Jublia® inCanada ), we have commenced (or anticipate commencing) and have (or may have) ongoing infringement proceedings against potential generic competitors in theU.S. andCanada . If we are not successful in these proceedings, we may face increased generic competition for these products. Xifaxan® 550mg Patent Litigation (Norwich) - OnMarch 26, 2020 , the Company and its licensor,Alfasigma , filed suit againstNorwich Pharmaceuticals Inc. ("Norwich"), alleging infringement by Norwich of one or more claims of the 23 Xifaxan® patents by Norwich's filing of its ANDA for Xifaxan® (rifaximin) 550 mg tablets. OnNovember 13, 2020 , an additional three patents alleged to be infringed by Norwich were added to the suit. Xifaxan® 550mg is protected by 26 patents covering the composition of matter and the use of Xifaxan® listed in theFDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. Trial in this matter was held inMarch 2022 . The court issued a final judgment onAugust 10, 2022 finding that theU.S. Patents protecting the use of Xifaxan® (rifaximin) 550 mg tablets for the reduction in risk of hepatic encephalopathy ("HE") recurrence valid and infringed and theU.S. Patents protecting the composition, and use of Xifaxan® for treating IBS-D invalid (the "Norwich Legal Decision"). The Company appealed the Norwich Legal Decision to theU.S. Court of Appeals for the Federal Circuit onAugust 16, 2022 . The Company remains confident in the strength of the Xifaxan® patents and intends to vigorously defend its intellectual property. See Note 18, "LEGAL PROCEEDINGS" to our unaudited interim Consolidated Financial Statements elsewhere in this Form 10-Q, as well as Note 20, "LEGAL PROCEEDINGS" of our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSEC and the CSA onFebruary 23, 2022 for further details regarding certain infringement proceedings. The risks of generic competition are a fact of the health care industry and are not specific to our operations or product portfolio. These risks are not avoidable, but we believe they are manageable. To manage these risks, our leadership team continually evaluates the impact that generic competition may have on future profitability and operations. In addition to aggressively defending the Company's patents and other intellectual property, our leadership team makes operational and investment decisions regarding these products and businesses at risk, not the least of which are decisions regarding our pipeline. Our leadership team actively manages the Company's pipeline in order to identify innovative and realizable projects aligned with our core businesses that are expected to provide incremental and sustainable revenues and growth into the future. We believe that our current pipeline is strong enough to meet these objectives and provide future sources of revenues, in our core businesses, sufficient enough to sustain our growth and corporate health as other products in our established portfolio face generic competition and lose momentum. We believe that we have a well-established product portfolio that is diversified within our core businesses. We also believe that we have a robust pipeline that not only provides for the next generation of our existing products, but also brings new solutions into the market.
See Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended
additional information on our competition risks.
Regulatory Matters
In the normal course of business, our products, devices and facilities are the subject of ongoing oversight and review by regulatory and governmental agencies, including general, for cause and pre-approval inspections by the relevant competent authorities where we have business operations. InAugust 2022 , we received a non-compliant rating fromHealth Canada related to our pharmaceutical manufacturing facility inLaval, Quebec . This rating was received without any restrictive conditions on plant operations so the production of important treatments for Canadians and for export continues without interruption. Through the date of this filing, all of our global operations and facilities have the relevant operational good manufacturing practices certificates and all Company products and operating sites are in good compliance standing with all relevant notified bodies and global health authorities. Further, all sites under FDA jurisdiction are rated as either No Action Indicated (where there was no Form 483 observation) or Voluntary Action Indicated ("VAI") (where there was a Form 483 with one or more observations). In the case of VAI inspection outcomes, the FDA has accepted our responses to the issues cited, which will be verified when the agency makes its next inspection of those specific facilities. 64 --------------------------------------------------------------------------------
FINANCIAL PERFORMANCE HIGHLIGHTS
The following table provides selected unaudited financial information for the
three and nine months ended
Three Months Ended September 30, Nine Months Ended September 30,
(in millions, except per share data) 2022 2021 Change 2022 2021 Change
Revenues $ 2,046 $ 2,111 $ (65) $ 5,931 $ 6,238 $ (307)
Operating income $ 244 $ 574
Income (loss) before income taxes
$ 223 $ 228 $ (1,045) $ 1,273 Net income (loss) attributable to Bausch Health Companies Inc.$ 399 $ 188 $ 211 $ 185 $ (1,017) $ 1,202 Basic$ 1.10 $ 0.52 $ 0.58 $ 0.51 $ (2.84) $ 3.35 Diluted$ 1.10 $ 0.52 $ 0.58 $ 0.51 $ (2.84) $ 3.35 Financial Performance
Summary of the Three Months Ended
Months Ended
Revenues for the three months endedSeptember 30, 2022 and 2021 were$2,046 million and$2,111 million , respectively, a decrease of$65 million , or 3%. The decrease was primarily due to: (i) the unfavorable impact of foreign currencies, primarily inEurope andAsia , (ii) the impact of our divestiture related to Amoun onJuly 26, 2021 , (iii) a decline in revenues in our Diversified Products segment partially offset by: (a) growth in revenue in Salix segment driven by improved net pricing and (b) an increase in net volumes and net pricing in our Bausch + Lomb and International segments. Operating income for the three months endedSeptember 30, 2022 and 2021 was$244 million and$574 million , respectively, a decrease in our operating results of$330 million and reflects, among other factors: •a decrease in contribution (Product sales revenue less Cost of goods sold, excluding amortization and impairments of intangible assets) of$66 million primarily due to: (i) the decrease in revenues as previously discussed and (ii) higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs;
•an increase in selling, general and administrative ("SG&A") of
primarily attributable to higher selling expenses related to freight and
administrative expenses partially offset by the favorable impact of foreign
currencies;
•an increase in R&D expenses of$12 million primarily attributable to lower R&D spend in 2021, as certain R&D activities and clinical trials which were suspended in response to the COVID-19 pandemic in 2020 and did not normalize until later in 2021;
•a decrease in Amortization of intangible assets of
attributable to fully amortized intangible assets no longer being amortized in
2022;
•an increase in
ended
goodwill of the
•a decrease in Asset impairments, including loss on assets held for sale of$17 million primarily attributable to higher impairments to certain products during the three monthsSeptember 30, 2021 ; and •an unfavorable change in Other expense (income), net of$187 million , primarily attributable to higher adjustments related to the insurance recoveries related to certain litigation matters partially offset by the loss on the completion of the Amoun sale during the three months endedSeptember 30, 2021 . Operating income for the three months endedSeptember 30, 2022 and 2021 was$244 million and$574 million , and included non-cash charges for Depreciation and amortization of intangible assets of$335 million and$382 million ,Goodwill impairments of$119 million and$0 , Asset impairments, including loss on assets held for sale, of$1 million and$18 million and Share-based compensation of$33 million and$33 million , respectively. Income before income taxes for the three months endedSeptember 30, 2022 and 2021 was$439 million and$216 million , respectively, an increase of$223 million . The increase in our Income before income taxes is primarily attributable to the favorable change in Gain (loss) on extinguishment of debt of$582 million driven by the impact of the 65 -------------------------------------------------------------------------------- Exchange Offer partially offset by: (i) the decrease in our operating results of$330 million , as previously discussed, and (ii) an increase in Interest expense of$34 million . Net income attributable toBausch Health for the three months endedSeptember 30, 2022 and 2021 was$399 million and$188 million , respectively, an increase in our results of$211 million . The increase in our results was primarily due to the increase in our Income before income taxes of$223 million , as previously discussed, partially offset by an unfavorable change in income taxes of$11 million .
Summary of the Nine Months Ended
Ended
Revenues for the nine months endedSeptember 30, 2022 and 2021 were$5,931 million and$6,238 million , respectively, a decrease of$307 million , or 5%. The decrease was primarily due to: (i) the unfavorable impact of foreign currencies, (ii) the impact of our divestiture of Amoun onJuly 26, 2021 and (iii) a decrease in volumes primarily attributable to our Diversified Products and Salix segments partially offset by an increase in volumes in our Bausch + Lomb and International segments. These decreases were partially offset by an increase in net realized pricing, primarily in our Salix, Bausch + Lomb and International segments. Operating income for the nine months endedSeptember 30, 2022 and 2021 was$690 million and$83 million , respectively, an increase in our operating results of$607 million and reflects, among other factors: •a decrease in contribution of$245 million primarily due to: (i) the decrease in revenues as previously discussed and (ii) higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs; •an increase in SG&A of$15 million primarily attributable to: (i) higher advertising and promotion expenses, (ii) higher freight and administrative expenses and (iii) higher compensation expenses partially offset by: (i) the favorable impact of foreign currencies and (ii) the impact of our divestiture of Amoun onJuly 26, 2021 ; •an increase in R&D of$39 million primarily attributable to lower R&D spend in 2021, as certain R&D activities and clinical trials which were suspended in response to the COVID-19 pandemic in 2020 and did not normalize until later in 2021; •a decrease in Amortization of intangible assets of$153 million primarily attributable to fully amortized intangible assets no longer being amortized in 2022; •a decrease inGoodwill impairments of$267 million as we recognized impairments associated with ourOrtho Dermatologics reporting unit of$202 million and$469 million for the nine months endedSeptember 30, 2022 and 2021, respectively; •a decrease in Asset impairments, including loss on assets held for sale of$198 million , primarily attributable to adjustments to the loss on assets held for sale in connection with the Amoun Sale during 2021; •an increase in Restructuring, integration, separation and IPO costs of$29 million primarily attributable to an increase in separation costs and IPO costs associated with the B+L Separation, the B+L IPO completed onMay 10, 2022 and the Solta IPO which was suspended inJune 2022 ; and •a favorable change in Other expense (income), net of$323 million primarily attributable to: (i) to higher adjustments related to the settlements of certain litigation matters during the nine months endedSeptember 30, 2021 and (ii) the loss on the completion of the Amoun Sale during the three months endedSeptember 30, 2021 , partially offset by insurance recoveries related to certain litigation matters during the three months endedSeptember 30, 2021 . Operating income for the nine months endedSeptember 30, 2022 and 2021 was$690 million and$83 million , respectively, and included non-cash charges for Depreciation and amortization of intangible assets of$1,034 million and$1,189 million , Asset impairments, including loss on assets held for sale of$15 million and$213 million ,Goodwill impairments of$202 million and$469 million and Share-based compensation of$91 million and$95 million , respectively. Income before income taxes for the nine months endedSeptember 30, 2022 was$228 million as compared to Loss before income taxes of$1,045 million for the nine months endedSeptember 30, 2021 , an increase in our results of$1,273 million . The increase in our results is primarily attributable to: (i) the favorable change in Gain (loss) on extinguishment of debt of$745 million primarily driven by the Exchange Offer and (ii) the increase in our operating results of$607 million , as previously discussed, partially offset by: (i) an increase in Interest expense of$74 million and (ii) the unfavorable net change in Foreign exchange and other of$7 million . Net income attributable toBausch Health for the nine months endedSeptember 30, 2022 was$185 million as compared to Net loss attributable toBausch Health of$1,017 million for the nine months endedSeptember 30, 2021 , an increase in our results of$1,202 million . The increase in our results was primarily due to the increase in our Income before 66 --------------------------------------------------------------------------------
income taxes of
unfavorable change in our provision for income taxes of
RESULTS OF OPERATIONS
Our unaudited operating results for the three and nine months ended
30, 2022
Three Months Ended September 30, Nine Months Ended September 30,
(in millions) 2022 2021 Change 2022 2021 Change
Revenues
Product sales $ 2,026 $ 2,088 $ (62) $ 5,871 $ 6,167 $ (296)
Other revenues 20 23 (3) 60 71 (11)
2,046 2,111 (65) 5,931 6,238 (307)
Expenses
Cost of goods sold (excluding
amortization and impairments of
intangible assets) 578 574 4 1,691 1,742 (51)
Cost of other revenues 6 8 (2) 21 26 (5)
Selling, general and administrative 661 653 8 1,959 1,944 15
Research and development 133 121 12 387 348 39
Amortization of intangible assets 290 338 (48) 902 1,055 (153)
Goodwill impairments 119 - 119 202 469 (267)
Asset impairments, including loss on
assets held for sale 1 18 (17) 15 213 (198)
Restructuring, integration, separation
and IPO costs 10 8 2 58 29 29
Other expense, net 4 (183) 187 6 329 (323)
1,802 1,537 265 5,241 6,155 (914)
Operating income 244 574 (330) 690 83 607
Interest income 3 2 1 8 6 2
Interest expense (385) (351) (34) (1,157) (1,083) (74)
Gain (loss) on extinguishment of debt 570 (12) 582 683 (62) 745
Foreign exchange and other 7 3 4 4 11 (7)
Income (loss) before income taxes 439 216 223 228 (1,045) 1,273
(Provision for) benefit from income taxes (36) (25) (11) (30) 36 (66)
Net income (loss) 403 191 212 198 (1,009) 1,207
Net income attributable to noncontrolling
interest (4) (3) (1) (13) (8) (5)
Net income (loss) attributable to Bausch
Health Companies Inc. $ 399 $ 188
Three Months Ended
Revenues
The Company's revenues are primarily generated from product sales, principally in the therapeutic areas of GI, dermatology and eye health, that consist of: (i) branded pharmaceuticals, (ii) generic and branded generic pharmaceuticals, (iii) OTC products and (iv) medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetic medical devices). Other revenues include alliance and service revenue from the licensing and co-promotion of products and contract service revenue primarily in the areas of dermatology and topical medication. Our revenues were$2,046 million and$2,111 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$65 million , or 3%. The decrease was due to: (i) the unfavorable impact of foreign currencies of$82 million , primarily inEurope andAsia , (ii) the impact of divestitures and discontinuations of$26 million , primarily attributable to our divestiture of Amoun onJuly 26, 2021 and (iii) a decrease in volumes of$5 million primarily due to decreases in our Diversified Products and Salix segments, partially offset by increases in volumes in our Bausch + Lomb and International segments. These decreases were partially offset by an increase in net realized pricing of$48 million , primarily in our Salix and Bausch + Lomb segments.
The changes in our segment revenues and segment profits for the three months
ended
subsequent section " - Reportable Segment Revenues and Profits".
67 --------------------------------------------------------------------------------
Cash Discounts and Allowances, Chargebacks and Distribution Fees
As is customary in the pharmaceutical industry, gross product sales are subject
to a variety of deductions in arriving at net product sales. Provisions for
these deductions are recognized concurrently with the recognition of gross
product sales. These provisions include cash discounts and allowances,
chargebacks, and distribution fees, which are paid or credited to direct
customers, as well as rebates and returns, which can be paid or credited to
direct and indirect customers. As more fully discussed in Note 3, "REVENUE
RECOGNITION" to our unaudited interim Consolidated Financial Statements, the
Company continually monitors the provisions for these deductions and evaluates
the estimates used as additional information becomes available. Price
appreciation credits are generated when we increase a product's wholesaler
acquisition cost ("WAC") under our contracts with certain wholesalers. Under
such contracts, we are entitled to credits from such wholesalers for the impact
of that WAC increase on inventory on hand at the wholesalers. In wholesaler
contracts, such credits are offset against the total distribution service fees
we pay on all of our products to each such wholesaler. In addition, some payor
contracts require discounting if a price increase or series of price increases
in a contract period exceeds a negotiated threshold. Provision balances relating
to amounts payable to direct customers are netted against trade receivables and
balances relating to indirect customers are included in accrued liabilities.
We actively manage these offerings, focusing on the incremental costs of our
patient assistance programs, the level of discounting to non-retail accounts and
identifying opportunities to minimize product returns. We also concentrate on
managing our relationships with our payors and wholesalers, reviewing the ranges
of our offerings and being disciplined as to the amount and type of incentives
we negotiate. Provisions recorded to reduce gross product sales to net product
sales and revenues for the three months ended September 30, 2022 and 2021 were
as follows:
Three Months Ended
2022 2021 (in millions) Amount Pct. Amount Pct. Gross product sales$ 3,460 100.0 %$ 3,437 100.0 % Provisions to reduce gross product sales to net product sales Discounts and allowances 149 4.3 % 166 4.8 % Returns 24 0.7 % 17 0.5 % Rebates 676 19.5 % 615 17.9 % Chargebacks 528 15.3 % 494 14.4 % Distribution fees 57 1.6 % 57 1.6 % Total provisions 1,434 41.4 % 1,349 39.2 % Net product sales 2,026 58.6 % 2,088 60.8 % Other revenues 20 23 Revenues$ 2,046 $ 2,111 Cash discounts and allowances, returns, rebates, chargebacks and distribution fees as a percentage of gross product sales were 41.4% and 39.2% for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of 2.2 percentage points and includes: •discounts and allowances as a percentage of gross product sales were lower primarily driven by higher discounts in 2021 for Glumetza® AG partially offset by: (i) higher gross sales for Xifaxan® and (ii) the impact of higher gross product sales and discount rates for certain generics; •returns were higher, however as a percentage of gross product sales remain below 1% primarily due to the Company's continued focus on maximizing operational efficiencies and actions to reduce product returns, including, but not limited to: (i) monitoring and reducing customer inventory levels, (ii) instituting disciplined pricing policies and (iii) improving contracting. These actions have had the effect of improving the sales return experience; •rebates as a percentage of gross product sales were higher primarily due to an increase in gross product sales and higher rebate rates for certain branded products such as Xifaxan®, Jublia®, Trulance® and Aplenzin®, partially offset by lower gross product sales and lower rebate rates for certain branded products such as Retin-A® Microsphere .06% and Retin-A® Microsphere .08% and Diastat® due to lower gross sales; 68
-------------------------------------------------------------------------------- •chargebacks as a percentage of gross product sales were higher primarily due to higher gross product sales and chargeback rates for certain branded products such as Glumetza® SLX and certain generic products such as Ofloxacin, Dorzolamide and Nifediac due to increased gross product sales and higher chargeback rates as a result of the impact of increased generic competition on pricing. These increases were partially offset by: (i) lower gross sales of certain generic products such as Apriso® AG and (ii) lower gross product sales and lower chargeback rates for certain branded products such as Xifaxan 200® and our neurology products Mysoline® and Atavin®; and •distribution service fees as a percentage of gross product sales were unchanged. Price appreciation credits are offset against distribution service fees when due to wholesalers. There were no price appreciation credits for the three months endedSeptember 30, 2022 and 2021.
Expenses
Cost of Goods Sold (excluding amortization and impairments of intangible assets)
Cost of goods sold primarily includes: manufacturing and packaging; the cost of products we purchase from third parties; royalty payments we make to third parties; depreciation of manufacturing facilities and equipment; and lower of cost or market adjustments to inventories. Cost of goods sold typically vary between periods as a result of product mix, volume, royalties, changes in foreign currency and inflation. Cost of goods sold excludes the amortization and impairments of intangible assets. Cost of goods sold was$578 million and$574 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$4 million , or 1%. The increase was primarily driven by: (i) the impact of the divestiture of Amoun onJuly 26, 2021 , (ii) the decrease in volumes previously discussed and (iii) the favorable impact of foreign currencies. These increases were partially offset by higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs. Cost of goods sold as a percentage of product sales revenue were 28.5% and 27.5% for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of 1.0 percentage points. Cost of goods sold as a percentage of product sales revenue was unfavorably impacted by higher manufacturing variances as previously discussed, partially offset by the increase in net realized pricing, as previously discussed.
Selling, General and Administrative Expenses
SG&A expenses primarily include: employee compensation associated with sales and marketing, finance, legal, information technology, human resources and other administrative functions; certain outside legal fees and consultancy costs; product promotion expenses; overhead and occupancy costs; depreciation of corporate facilities and equipment; and other general and administrative costs. The Company has also incurred, and expects to continue to incur with respect to the B+L Separation, separation-related and IPO-related costs which are incremental costs indirectly related to the B+L Separation and the suspended Solta IPO including, but are not limited to: (i) IT infrastructure and software licensing costs, (ii) rebranding costs and (iii) costs associated with facility relocation and/or modification. SG&A expenses were$661 million and$653 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$8 million , or 1%. The increase was primarily attributable to higher selling expenses related to freight and administrative expenses partially offset by the favorable impact of foreign currencies
Research and Development Expenses
Included in Research and development are costs related to our product development and quality assurance programs. Expenses related to product development include: employee compensation costs; overhead and occupancy costs; depreciation of research and development facilities and equipment; clinical trial costs; clinical manufacturing and scale-up costs; and other third-party development costs. Quality assurance are the costs incurred to meet evolving customer and regulatory standards and include: employee compensation costs; overhead and occupancy costs; amortization of software; and other third-party costs. R&D expenses were$133 million and$121 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$12 million , or 10%. R&D expenses as a percentage of Product sales were approximately 7% and 6% for the three months endedSeptember 30, 2022 and 2021, respectively. The increase was primarily attributable to: (i) lower R&D spend in 2021, as certain R&D activities and clinical trials which were suspended in response to the COVID-19 pandemic in 2020 and did not normalize until later in 2021, as discussed below, and (ii) higher spend on certain Solta and Bausch + Lomb projects. In 2020, due to the COVID-19 pandemic, certain of our R&D activities were limited and others, including new patient enrollments in clinical trials, were temporarily paused, as most trial sites were not able to accept new patients due to 69
-------------------------------------------------------------------------------- government-mandated shutdowns. During our third quarter of 2020, many of these trial sites began to reopen. During 2021, the pace of new patient enrollments and the increase in these activities and related R&D spend gradually increased until they approached a normalized spend rate toward the end of 2021. As of the date of this filing, we have not had to make material changes to our development timelines and the pause in our clinical trials has not had a material impact on our operating results; however, a resurgence of COVID-19 could result in unanticipated delays in our ability to conduct new patient enrollments and create other delays which could have a significant adverse effect on our future operating results.
Amortization of Intangible Assets
Intangible assets with finite lives are amortized using the straight-line method over their estimated useful lives, generally 2 to 20 years. Management continually assesses the useful lives related to the Company's long-lived assets to reflect the most current assumptions. Amortization of intangible assets was$290 million and$338 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$48 million . The decrease was primarily attributable to fully amortized intangible assets no longer being amortized in 2022.
See Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim
Consolidated Financial Statements for further details related to our intangible
assets.
Goodwill ImpairmentsGoodwill is not amortized but is tested for impairment at least annually onOctober 1st at the reporting unit level. A reporting unit is the same as, or one level below, an operating segment. The Company performs its annual impairment test by first assessing qualitative factors. Where the qualitative assessment suggests that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, a quantitative fair value test is performed for that reporting unit.
During the third quarter of 2022, we continued to monitor the market conditions impacting theOrtho Dermatologics reporting unit. As a result of an impairment to the goodwill of theOrtho Dermatologics reporting unit recognized in second quarter of 2022, the reporting unit had no headroom as calculated onJune 30, 2022 . We considered the increases in interest rates, higher than expected inflation in theU.S. and other macroeconomic factors which would impact the key assumptions used to value theOrtho Dermatologics reporting unit atJune 30, 2022 (the last time goodwill of theOrtho Dermatologics reporting unit was tested). We believed these facts and circumstances suggest the fair value of theOrtho Dermatologics reporting unit could be less than its carrying amount, and therefore a quantitative fair value test was performed for the reporting unit. The quantitative fair value test utilized the Company's most recent cash flow projections as revised in the third quarter of 2022 which reflect current market conditions and current trends in business performance. The Company updated revenue assumptions for a certain product and other products reaching LOE and updated its assumptions regarding selling, advertising and promotion investments. The Company also increased the discount rate used in the valuation of the reporting unit from 10.0% utilized in theJune 30, 2022 testing to 10.5% utilized in theSeptember 30, 2022 testing which reflects the increases in market interest rates. The Company has not changed its long-term growth rate assumption of 1%. Based on the quantitative fair value test, the carrying value of theOrtho Dermatologics reporting unit exceeded its fair value atSeptember 30, 2022 , and we recognized a goodwill impairment of$119 million .
Salix
On
other matters, that certain
Xifaxan® for treating IBS-D were invalid. On
appealed this decision and intends to vigorously defend its Xifaxan®
intellectual property. See "Xifaxan® Paragraph IV Proceedings" of Note 18,
"LEGAL PROCEEDINGS" for details of this litigation matter and the Company's
response.
70 -------------------------------------------------------------------------------- Xifaxan® revenues were$1,216 million and$1,194 million for the nine months endedSeptember 30, 2022 and 2021, respectively, representing approximately 80% of the revenues of the Salix reporting unit. The ultimate outcome of the Norwich Legal Decision and other potential future related developments, including a competitor's ability to launch a successful generic version to Xifaxan®, could impact the timing and extent of future revenues and cash flows associated with Xifaxan®. As such, the Company believes that the uncertainty of the possible outcomes of the Norwich Legal Decision and the potential impact on Xifaxan® revenues are indicators that the Salix reporting unit's fair value could be less than its carrying amount, and therefore a quantitative fair value test was performed for the reporting unit. The Company performed its quantitative fair value test using a probability-weighted discounted cash flow analysis, with a base case representing the Company's most recent cash flow projections as revised in the third quarter of 2022, as well as different scenarios representing a range of different outcomes which address, among other things, the range of possible outcomes of the Norwich Legal Decision and the timing of when a competitor or competitors could be able to successfully launch a generic version of Xifaxan®, if they are able to launch one at all. The forecasted cash flows under each set of outcomes were discounted utilizing a long-term growth rate of 2.5% and discount rates of 9.75% and 10.00%. The Company assigned a probability weighting to each scenario reflecting its best estimate of likelihood of the outcome resulting in each scenario, and calculated a weighted average of the valuations derived from the discounted cash flows under each scenario using this probability weighting. As ofSeptember 30, 2022 , the carrying value of the Salix reporting unit was less than its fair value as determined by the Company's probability-weighted discount valuation model and therefore no impairment was recorded as ofSeptember 30, 2022 . However, as the Company's probability-weighted discount valuation includes scenarios under which the Company does not retain market exclusivity for Xifaxan® throughJanuary 2028 , these probability-weighted fair values of the Salix reporting unit exceeded its carrying value by less than 5%.
It is possible that the Norwich Legal Decision and other potential future
developments may adversely impact the estimated fair value of the Salix segment
in one or more future periods. Any such impairment could be material to the
Company's results of operations in the period in which it were to occur.
Other Reporting Units
No other events occurred or circumstances changed during the three months endedSeptember 30, 2022 that would indicate that the fair value of any reporting unit, other than theOrtho Dermatologics and Salix reporting units, might be below its carrying value.
See Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim
Consolidated Financial Statements for further details related to our goodwill.
Asset Impairments, Including Loss on Assets Held for Sale
Long-lived assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Impairment charges associated with these assets are included in Asset impairments in the Consolidated Statement of Operations. The Company continues to monitor the recoverability of its finite-lived intangible assets and tests the intangible assets for impairment if indicators of impairment are present. Asset impairments, including loss on assets held for sale were$1 million and$18 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$17 million . Asset impairments, including loss on assets held for sale for the three months endedSeptember 30, 2022 of$1 million was related to the discontinuance of a specific product. Asset impairments, including loss on assets held for sale for the three months endedSeptember 30, 2021 of$18 million include: (i) impairments of$9 million due to decreases in forecasted sales of a certain product line in our Diversified Products segment and (ii) impairments of$9 million , in aggregate, related to the discontinuance of certain product lines. Xifaxan® intangible assets included in the unaudited Consolidated Balance Sheets have a carrying value of$2,828 million and an estimated remaining useful life of 63 months as ofSeptember 30, 2022 . The Company determined that the Norwich Legal Decision constituted an event requiring assessment of the Xifaxan® intangible assets for potential impairment. The Company performed this assessment using the same probability-weighted undiscounted cash flow analysis it used in assessing the goodwill of the Salix reporting unit for impairment discussed above. This assessment resulted in no impairment of the carrying value of the Xifaxan® intangible assets as ofSeptember 30, 2022 . The Company also determined 71
--------------------------------------------------------------------------------
that no change to the remaining useful lives of its Xifaxan® intangible assets
was required as of
It is possible that the Norwich Legal Decision and other potential future related developments: (i) may adversely impact the estimated future cash flows associated with these products, which could result in an impairment of the value of these intangible assets in one or more future periods and (ii) may result in shortened useful lives of the Xifaxan® intangible assets, which would increase amortization expense in future periods.
See Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim
Consolidated Financial Statements for further details related to our intangible
assets.
Restructuring, Integration, Separation and IPO Costs
Restructuring, integration, separation and IPO costs were$10 million and$8 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$2 million .
Restructuring and Integration Costs
The Company evaluates opportunities to improve its operating results and implement cost savings programs to streamline its operations and eliminate redundant processes and expenses. Restructuring and integration costs are expenses associated with the implementation of these cost savings programs and include expenses associated with: (i) reducing headcount, (ii) eliminating real estate costs associated with unused or under-utilized facilities and (iii) implementing contribution margin improvement and other cost reduction initiatives. Restructuring and integration costs were$3 million for the three months endedSeptember 30, 2022 and 2021, in each period. The Company continues to evaluate opportunities to streamline its operations and identify additional cost savings globally. Although a specific plan does not exist at this time, the Company may identify and take additional exit and cost-rationalization restructuring actions in the future, the costs of which could be material.
Separation and IPO Costs
The Company has incurred, and expects to continue to incur costs associated with activities relating to the B+L Separation. The Company also incurred costs associated with activities relating to the Solta IPO, which was suspended inJune 2022 . These B+L Separation and Solta IPO activities include: (i) separating the Bausch + Lomb andSolta Medical businesses from the remainder of the Company, (ii) completing the B+L IPO and preparing for the suspended Solta IPO and (iii) the actions necessary for Bausch + Lomb to become an independent publicly traded entity. Separation and IPO costs are incremental costs directly related to the ongoing B+L Separation and the suspended Solta IPO and include, but are not limited to: (i) legal, audit and advisory fees, (ii) talent acquisition costs and (iii) costs associated with establishing a new board of directors and related board committees for the Bausch + Lomb andSolta Medical entities. Separation and IPO costs were$7 million and$5 million for the three months endedSeptember 30, 2022 and 2021, respectively. The extent and timing of future charges of these costs to complete the B+L Separation cannot be reasonably estimated at this time and could be material.
See Note 5, "RESTRUCTURING, INTEGRATION, SEPARATION AND IPO COSTS" to our
unaudited interim Consolidated Financial Statements for further details
regarding these actions.
Other expense, net
Other expense, net for the three months endedSeptember 30, 2022 and 2021 consists of the following: Three Months Ended September 30, (in millions) 2022 2021 Litigation and other matters $ -$ (212) Acquisition-related contingent consideration 4 8 (Gain) loss on sale of assets, net - 21$ 4 $ (183) Litigation and other matters for the three months endedSeptember 30, 2021 , included insurance recoveries of$213 million related to a certain litigation. Loss on sale of assets for the three months endedSeptember 30, 2021 , included a loss of$26 million upon completion of the Amoun Sale as discussed in Note 4, "LICENSING AGREEMENTS AND DIVESTITURE" to our unaudited interim Consolidated Financial Statements. 72
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Non-Operating Income and Expense
Interest Expense
Interest expense primarily consists of interest payments due, amortization of debt premiums, discounts and deferred issuance costs on indebtedness under our credit facilities and notes and, during 2021, the amortization of amounts excluded from the assessment of hedge effectiveness over the term of the Company's cross-currency swaps. InNovember 2021 , we entered into a transaction to unwind our cross-currency swaps. InJuly 2022 , Bausch +Lomb entered into new cross-currency swaps with aggregate notional amounts of$1,000 million . Interest expense was$385 million and$351 million , and included non-cash amortization and write-offs of debt premiums, discounts and deferred issuance costs of$22 million and$17 million , for the three months endedSeptember 30, 2022 and 2021, respectively. Interest expense for the three months endedSeptember 30, 2022 increased$34 million , or 10%, as compared to the three months endedSeptember 30, 2021 , primarily attributable to the higher interest rates partially offset by the impact of lower outstanding debt balances. The weighted average stated rate of interest as ofSeptember 30, 2022 and 2021 was 7.24% and 5.91%, respectively. The increase in the weighted average stated rate of interest of 133 bps is primarily attributable to the New Secured Notes. Due to the accounting treatment for the New Secured Notes, interest expense in the Company's financial statements in future periods will not be representative of the weighted average stated rate of interest.
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated
Financial Statements and the section titled "- Liquidity and Capital Resources -
Liquidity and Debt - Long-term Debt" for further details.
Gain (Loss) on Extinguishment of Debt
Gain (loss) on extinguishment of debt represents the differences between the amounts paid to settle extinguished debts and the carrying value of the related extinguished debt. The gain on extinguishment of debt was$570 million for the three months endedSeptember 30, 2022 was attributable to the Exchange Offer, as compared to a loss on extinguishment of debt of$12 million for the three months endedSeptember 30, 2021 . The Exchange Offer is discussed in further detail under "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt" below. The Company continues to take steps to seek to improve its operating results to ensure continual compliance with its financial maintenance covenants and take other actions to reduce its debt levels to align with the Company's long-term strategy. The Company may consider taking other actions, including divesting other businesses, refinancing debt and issuing equity or equity-linked securities including secondary offerings of the common shares of Bausch + Lomb, as deemed appropriate, to provide additional coverage in complying with the financial maintenance covenant and meeting its debt service obligations. The loss on extinguishment of debt of$12 million for the three months endedSeptember 30, 2021 is primarily associated with debt repayments made during the three months endedSeptember 30, 2021 and represents the differences between the amounts paid to settle the extinguished debt and its carrying value.
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated
Financial Statements for further details.
Foreign Exchange and Other
Foreign exchange and other primarily includes: (i) translation gains/losses on intercompany loans and third-party liabilities and (ii) the gain/loss due to foreign currency exchange contracts. Foreign exchange and other was a gain of$7 million and$3 million for the three months endedSeptember 30, 2022 and 2021, respectively, a favorable net change of$4 million .
Income Taxes
Provision for income taxes was
ended
Our effective income tax rate for the three months endedSeptember 30, 2022 differs from the statutory Canadian income tax rate primarily due to: (i) the tax provision generated from our annualized mix of earnings by jurisdiction, (ii) the recording of valuation allowance on entities for which no tax benefit of losses is expected and (iii) the discrete treatment of certain tax matters, primarily related to: (a) changes in uncertain tax positions, (b) adjustments for book to income tax return provisions and (c) changes to the tax deduction for stock compensation. Our effective income tax rate for the three months endedSeptember 30, 2021 differs from the statutory Canadian income tax rate primarily due to: (i) the tax benefit generated from our annualized mix of earnings by jurisdiction, (ii) the recording of valuation allowance on entities for which no tax benefit of losses is expected and (iii) the discrete treatment of 73 --------------------------------------------------------------------------------
certain tax matters, primarily related to: (a) changes in uncertain tax
positions, (b) adjustments for book to income tax return provisions and (c) tax
deduction for stock compensation.
See Note 16, "INCOME TAXES" to our unaudited interim Consolidated Financial
Statements for further details.
Reportable Segment Revenues and Profits
The following is a brief description of the Company's segments:
•The Salix segment consists of sales in the
Xifaxan® product line represented approximately 80% of the Salix segment's
revenues for the three and nine months ended
•The International segment consists of sales, with the exception of sales of Bausch + Lomb products and Solta aesthetic medical devices, outside theU.S. andPuerto Rico of branded pharmaceutical products, branded generic pharmaceutical products and OTC products.
•The Solta Medical segment consists of global sales of Solta aesthetic medical
devices.
•The Diversified Products segment consists of sales in the
pharmaceutical products in the areas of neurology and certain other therapeutic
classes, (ii) generic products, (iii)
products and (iv) dentistry products.
•The Bausch + Lomb segment consists of global sales of Bausch + Lomb Vision
Care,
Segment profit is based on operating income after the elimination of intercompany transactions, including between Bausch + Lomb and other segments. Certain costs, such as Amortization of intangible assets, Asset impairments,Goodwill impairments, Restructuring, integration, separation and IPO costs and Other (income) expense, net, are not included in the measure of segment profit, as management excludes these items in assessing segment financial performance. See Note 19, "SEGMENT INFORMATION" to our unaudited interim Consolidated Financial Statements for a reconciliation of segment profit to Income (loss) before income taxes. The following table presents segment revenues, segment revenues as a percentage of total revenues, and the period-over-period changes in segment revenues for the three months endedSeptember 30, 2022 and 2021. The following table also presents segment profits, segment profits as a percentage of segment revenues and the period-over-period changes in segment profits for the three months endedSeptember 30, 2022 and 2021.
Three Months Ended
2022 2021 Change (in millions) Amount Pct. Amount Pct. Amount Pct. Segment Revenues Salix$ 544 27 %$ 527 24 %$ 17 3 % International 250 12 % 271 13 % (21) (8) % Solta Medical 72 4 % 74 4 % (2) (3) % Diversified Products 238 12 % 290 14 % (52) (18) % Bausch + Lomb 942 45 % 949 45 % (7) (1) % Total revenues$ 2,046 100 %$ 2,111 100 %$ (65) (3) % Segment Profits / Segment Profit Margins Salix$ 391 72 %$ 377 72 %$ 14 4 % International 85 34 % 92 34 % (7) (8) % Solta Medical 33 46 % 40 54 % (7) (18) % Diversified Products 151 63 % 185 64 % (34) (18) % Bausch + Lomb 226 24 % 247 26 % (21) (9) % Total segment profits$ 886 43 %$ 941 45 %$ (55) (6) %
Organic Revenues and Organic Growth Rates (non-GAAP)
74 -------------------------------------------------------------------------------- Organic revenue and organic revenue change are non-GAAP measures. Non-GAAP measures are not standardized measures under the financial reporting framework used to prepare the Company's financial statements and might not be comparable to similar financial measures disclosed by other issuers. Organic revenue (non-GAAP) and change in organic revenue (non-GAAP), are defined as GAAP Revenue and change in GAAP revenue (the most directly comparable GAAP financial measures), adjusted for changes in foreign currency exchange rates (if applicable) and excluding the impact of recent acquisitions, divestitures and discontinuations, as defined below. Organic revenue (non-GAAP) is impacted by changes in product volumes and price. The price component is made up of two key drivers: (i) changes in product gross selling price and (ii) changes in sales deductions. The Company uses organic revenue (non-GAAP) and change in organic revenue (non-GAAP) to assess performance of its reportable segments, and the Company in total. The Company believes that providing these measures is useful to investors as they provide a supplemental period-to-period comparison.
The adjustments to GAAP Revenue and changes in GAAP revenue to determine organic
revenue (non-GAAP) and changes in organic revenue (non-GAAP) are as follows:
Foreign currency exchange rates: Although changes in foreign currency exchange rates are part of our business, they are not within management's control. Changes in foreign currency exchange rates, however, can mask positive or negative trends in the business. The impact of changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. Acquisitions, divestitures and discontinuations: In order to present period-over-period organic revenue (non-GAAP) growth/change on a comparable basis, revenues associated with acquisitions, divestitures and discontinuations are adjusted to include only revenues from those businesses and assets owned during both periods. Accordingly, organic revenue and organic growth/change exclude from the current period, revenues attributable to each acquisition for twelve months subsequent to the day of acquisition, as there are no revenues from those businesses and assets included in the comparable prior period. Organic revenue and change in organic revenue exclude from the prior period, all revenues attributable to each divestiture and discontinuance during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period. There were no acquisitions during the twelve month period endedSeptember 30, 2022 . The following table presents a reconciliation of GAAP revenues to organic revenues (non-GAAP) and the period-over-period changes in organic revenue (non-GAAP) for the three months endedSeptember 30, 2022 and 2021 by segment. Three Months Ended September 30, 2022 Three Months Ended September 30, 2021 Change in Revenue Revenue Organic Revenue (Non-GAAP) as Changes in Organic Revenue as Divestitures Organic Revenue (in millions) Reported Exchange Rates (Non-GAAP) Reported and Discontinuations (Non-GAAP) Amount Pct. Salix$ 544 $ - $ 544$ 527 $ - $ 527 $ 17 3 % International 250 22 272 271 (23) 248 24 10 %Solta Medical 72 5 77 74 - 74 3 4 % Diversified Products 238 - 238 290 (2) 288 (50) (17) % Bausch + Lomb 942 55 997 949 (1) 948 49 5 % Total$ 2,046 $ 82$ 2,128 $ 2,111 $ (26)$ 2,085 $ 43 2 % Salix Segment: Salix Segment Revenue The Salix segment includes our Xifaxan® product line. Revenues from our Xifaxan® product line accounted for approximately 80% of the Salix segment revenues for the three months endedSeptember 30, 2022 and 2021, in each period. No other single product group represents 10% or more of the Salix segment product sales. Salix segment revenue for the three months endedSeptember 30, 2022 and 2021 was$544 million and$527 million , respectively, an increase of$17 million , or 3%. The increase is primarily driven by an increase in net realized pricing of$29 million , primarily driven by Xifaxan®, partially offset by a decrease in volumes of$12 million primarily attributable to unfavorable inventory balancing of Xifaxan® by certain wholesalers.
Salix Segment Profit
The Salix segment profit for the three months endedSeptember 30, 2022 and 2021 was$391 million and$377 million , respectively, an increase of$14 million , or 4%. The increase was primarily driven by an increase in contribution primarily attributable to the increase in revenues, as previously discussed. 75 --------------------------------------------------------------------------------
International Segment:
International Segment Revenue
The International segment has a diversified product line with no single product group representing 10% or more of its product sales. The International segment revenue was$250 million and$271 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$21 million , or 8%. The decrease was primarily attributable to: (i) the impact of divestitures and discontinuations of$23 million , primarily attributable to our divestiture of Amoun onJuly 26, 2021 and (ii) the unfavorable impact of foreign currencies of$22 million , primarily inEurope . These decreases were partially offset by increases in: (i) volumes of$16 million and (ii) net realized pricing of$8 million . International Segment Profit The International segment profit for the three months endedSeptember 30, 2022 and 2021 was$85 million and$92 million , respectively, a decrease of$7 million , or 8%. The decrease was primarily attributable to: (i) our divestiture of Amoun onJuly 26, 2021 and (ii) lower contribution primarily attributable to the unfavorable impact of foreign currencies and by higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs. Solta Medical Segment: Solta Medical Segment Revenue TheSolta Medical segment includes the Thermage® product line, which accounted for approximately 81% of the Solta segment revenues for the three months endedSeptember 30, 2022 . No other single product group represents 10% or more of the Solta segment revenues. TheSolta Medical segment revenue for the three months endedSeptember 30, 2022 and 2021 was$72 million and$74 million , respectively, a decrease of$2 million , or 3%. The decrease was primarily attributable to the unfavorable impact of foreign currencies of$5 million partially offset by an increase in net realized pricing of$3 million .
Solta Medical Segment Profit
TheSolta Medical segment profit for the three months endedSeptember 30, 2022 and 2021 was$33 million and$40 million , respectively, a decrease of$7 million , or 18%. The decrease was attributable to: (i) the decrease in contribution primarily driven by higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs, (ii) an increase in R&D and (iii) the unfavorable impact of foreign currencies.
Diversified Products Segment:
Diversified Products Segment Revenue
The Diversified Products segment revenue for the three months endedSeptember 30, 2022 and 2021 was$238 million and$290 million , respectively, a decrease of$52 million , or 18%. The decrease was primarily driven by: (i) a decrease in volume of$34 million , primarily attributable to our Neurology and Generics businesses and (ii) a decrease in net realized pricing of$16 million , primarily in our Generics business.
Diversified Products Segment Profit
The Diversified Products segment profit for the three months endedSeptember 30, 2022 and 2021 was$151 million and$185 million , respectively, a decrease of$34 million , or 18%. The decrease was primarily driven by the decrease in contribution attributable to the net decrease in revenues, as previously discussed, partially offset by lower general and administrative expenses.
Bausch + Lomb Segment:
Bausch + Lomb Segment Revenue
The Bausch + Lomb segment has a diversified product line with no single product group representing 10% or more of its product sales. The Bausch + Lomb segment revenue was$942 million and$949 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$7 million , or 1%. The decrease was attributable to (i) the unfavorable impact of foreign currencies across the Bausch + Lomb international businesses of$55 million primarily inEurope andAsia and (ii) the impact of divestitures and discontinuations of$1 million , related to the discontinuation of certain products. These decreases were partially offset by increases in: (i) volumes of$25 million and (ii) net realized pricing of$24 million primarily within the Vision Care business. The increase in volume was due to: (i) new launches within the international contact lens business, (ii) increased demand of consumables and IOLs within the Surgical business and (iii) increased demand and new launches within theOphthalmic Pharmaceuticals business. Bausch + Lomb Segment Profit 76
-------------------------------------------------------------------------------- The Bausch + Lomb segment profit for the three months endedSeptember 30, 2022 and 2021 was$226 million and$247 million , respectively, a decrease of$21 million , or 9%. The decrease was primarily attributable to: (i) a decrease in contribution primarily driven by: (a) the decrease in revenues as previously discussed and (b) higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of Daily SiHy lenses and (ii) higher R&D expense.
Nine Months Ended
30, 2021
Revenues Our revenue was$5,931 million and$6,238 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$307 million , or 5%. The decrease was due to: (i) the unfavorable impact of foreign currencies of$186 million primarily inEurope andAsia , (ii) the impact of divestitures and discontinuations of$172 million , primarily attributable to our divestiture of Amoun onJuly 26, 2021 and (iii) a decrease in volumes of$79 million primarily in our Diversified, Salix and Solta segments partially offset by an increase in volumes in our Bausch + Lomb and International segments. These decreases were partially offset by an increase in net realized pricing of$130 million .
The changes in our segment revenues and segment profits for the nine months
ended
subsequent section " - Reportable Segment Revenues and Profits".
Cash Discounts and Allowances, Chargebacks and Distribution Fees
Provisions recorded to reduce gross product sales to net product sales and
revenues for the nine months ended
Nine Months Ended
2022 2021 (in millions) Amount Pct. Amount Pct. Gross product sales$ 10,015 100.0 %$ 10,229 100.0 % Provisions to reduce gross product sales to net product sales Discounts and allowances 427 4.3 % 472 4.6 % Returns 84 0.8 % 94 0.9 % Rebates 1,912 19.1 % 1,842 18.0 % Chargebacks 1,556 15.5 % 1,487 14.6 % Distribution fees 165 1.6 % 167 1.6 % Total provisions 4,144 41.4 % 4,062 39.7 % Net product sales 5,871 58.6 % 6,167 60.3 % Other revenues 60 71 Revenues$ 5,931 $ 6,238 Cash discounts and allowances, returns, rebates, chargebacks and distribution fees as a percentage of gross product sales were 41.4% and 39.7% for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of 1.7 percentage points and includes: •discounts and allowances as a percentage of gross product sales were lower primarily due to lower gross product sales for certain generic products, such as Glumetza® AG, Timoptic® AG, Apriso® AG and Migranal® AG; •returns as a percentage of gross product sales were lower primarily due to: (i) the result of the Company's improving return experience and (ii) the favorable year over year impact due to the recall of certain Bausch + Lomb consumer products as a result of a quality issue at a third-party supplier during the three months endedJune 30, 2021 , as discussed below. Over the last several years, the Company has increased its focus on maximizing operational efficiencies and continues to take actions to reduce product returns, including, but not limited to: (i) monitoring and reducing customer inventory levels, (ii) instituting disciplined pricing policies and (iii) improving contracting. These actions have had the effect of improving the sales return experience primarily for certain of our branded products such as Xifaxan®,Trulance® and Relistor®. These factors driving our lower return experience were partially offset by charges in our International segment of approximately$11 million during the three months endedJune 30, 2022 , to reflect a change in estimated future returns in one market, driven by lower estimated demand following the easing of local COVID-19 lockdown restrictions and a change of distributors; 77 -------------------------------------------------------------------------------- •rebates as a percentage of gross product sales were higher primarily due the impact of an increase in gross product sales of certain branded products with higher rebate rates, such as Jublia®, Aplenzin®, Arazlo® and Trulance®, partially offset by lower gross product sales and lower rebate rates for certain branded products such as Wellbutrin®, Retin-A® Microsphere .06% and Retin-A® Microsphere .08% and the generic product Glumetza® AG; •chargebacks as a percentage of gross product sales were higher primarily due to higher chargeback rates for certain products such as Glumetza® SLX, Ofloxacin and Xifaxan®, partially offset by lower chargeback rates and gross product sales for certain generic products such as Glumetza® AG and Targretin® AG and certain branded products such as Mysoline® and Ativan®; and
•distribution service fees as a percentage of gross product sales were
unchanged. Price appreciation credits were
ended
Expenses
Cost of Goods Sold (excluding amortization and impairments of intangible assets)
Cost of goods sold was$1,691 million and$1,742 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$51 million , or 3%. The decrease was primarily driven by: (i) the impact of the divestiture of Amoun onJuly 26, 2021 , (ii) the net decrease in volumes, as previously discussed, and (iii) the favorable impact of foreign currencies. These decreases were partially offset by higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs, partially offset by the impact of manufacturing variances incurred in 2021 related to a quality issue at a third-party supplier, as discussed below. In 2021,Bausch + Lomb Incorporated ("B&L Inc. ") was notified by a third-party supplier of sterilization services for its lens care solution bottles and caps at itsMilan, Italy facility, of inconsistencies in the sterilization data versus certificates of conformance previously submitted toB&L Inc. by that supplier. Based onB&L Inc.'s internal Health and Safety Analysis, it was determined that this issue did not affect the safety or performance of any of its products and was limited to a specific number of lots for certain Consumer products within our Bausch + Lomb segment. However, out of an abundance of caution and working with the appropriate notified body and responsible health authorities,B&L Inc. has contained and/or recalled down to the consumer level the limited number of affected lots of products resulting in$8 million of manufacturing variances and$6 million of returns during the nine months endedSeptember 30, 2021 . Further, althoughB&L Inc.'s Greenville, South Carolina facility increased production to support some of the demand in the near term, due to the limited availability of qualified materials, production at theMilan facility could not keep up with demand which negatively impacted sales for the affected products in this region during the nine months endedSeptember 30, 2021 . During the third quarter of 2021,B&L Inc. had removed this supplier from its Approved Supplier List and qualified another sterilization supplier, who, along with an existing secondary supplier, will provide bottle sterilization, thereby allowing theMilan facility to return to full production capacity. Cost of goods sold as a percentage of product sales revenue was 28.8% and 28.2% for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of 0.6 percentage points. Costs of goods sold as a percentage of Product sales revenue was unfavorably impacted by higher manufacturing variances as previously discussed, partially offset by the increase in net realized pricing, as previously discussed.
Selling, General and Administrative Expenses
SG&A expenses were$1,959 million and$1,944 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$15 million , or 1%. The increase was primarily attributable to higher selling expenses related to freight and administrative expenses partially offset by: (i) the impact of our divestiture of Amoun onJuly 26, 2021 and (ii) the favorable impact of foreign currencies. Research and Development R&D expenses were$387 million and$348 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$39 million , or 11%. R&D expenses as a percentage of Product sales were approximately 7% and 6% for the nine months endedSeptember 30, 2022 and 2021, respectively. The increase was primarily due to: (i) the result of lower R&D spend in early 2021 as certain R&D activities and clinical trials which were suspended in response to the COVID-19 pandemic in 2020 and did not normalize until later in 2021, as previously discussed, and (ii) higher spend on certain Solta and Bausch + Lomb projects. 78
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Amortization of Intangible Assets
Amortization of intangible assets was$902 million and$1,055 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$153 million , or 15%. The decrease was primarily attributable to fully amortized intangible assets no longer being amortized in 2022.
See Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim
Consolidated Financial Statements for further details related to our intangible
assets.
Goodwill ImpairmentsGoodwill impairments were$202 million for the nine months endedSeptember 30, 2022 , related to ourOrtho Dermatologics unit as previously discussed, and for the nine months endedSeptember 30, 2021 were$469 million .
2022
During the second quarter of 2022, increases in interest rates and, to a lesser extent, higher than expected inflation in theU.S. and other macroeconomic factors impacted key assumptions used to value theOrtho Dermatologics reporting unit atMarch 31, 2022 (the last time goodwill of theOrtho Dermatologics reporting unit was tested). Given the limited headroom of theOrtho Dermatologics reporting unit as calculated onMarch 31, 2022 , we believed that these facts and circumstances suggested the fair value of theOrtho Dermatologics reporting unit could be less than its carrying amount, and therefore a quantitative fair value test was performed for the reporting unit. Based on the quantitative fair value test, the carrying value of theOrtho Dermatologics reporting unit exceeded its fair value atJune 30, 2022 , and we recognized a goodwill impairment of$83 million . As previously discussed, during the third quarter of 2022 we continued to monitor the market conditions impacting theOrtho Dermatologics reporting unit and determined that facts and circumstances suggest the fair value of theOrtho Dermatologics reporting unit could be less than its carrying amount, and therefore a quantitative fair value test was performed for the reporting unit. Based on the quantitative fair value test, the carrying value of theOrtho Dermatologics reporting unit exceeded its fair value atSeptember 30, 2022 , and we recognized a goodwill impairment of$119 million .
Salix
As previously discussed, the ultimate outcome of the Norwich Legal Decision (see "Xifaxan® Paragraph IV Proceedings" of Note 18, "LEGAL PROCEEDINGS" for details of this litigation matter and the Company's response) and other potential future developments, including a competitor's ability to launch a successful generic version to Xifaxan®, could impact the timing and extent of future revenues and cash flows associated with Xifaxan®. As such, the Company believes that the uncertainty of the possible outcomes of the Norwich Legal Decision and the potential impact on Xifaxan® revenues are indicators that the Salix reporting unit's fair value could be less than its carrying amount, and therefore a quantitative fair value test was performed for the reporting unit. As ofSeptember 30, 2022 , the carrying value of the Salix reporting unit was less than its fair value as determined by the Company's probability-weighted discount valuation model and therefore no impairment was recorded. However, as the Company's probability-weighted discount valuation includes scenarios under which the Company does not retain market exclusivity for Xifaxan® throughJanuary 2028 , these probability-weighted fair values of the Salix reporting unit exceeded its carrying value by less than 5%.
It is possible that the Norwich Legal Decision and other potential future
developments may adversely impact the estimated fair value of the Salix segment
in one or more future periods. Any such impairment could be material to the
Company's results of operations in the period in which it were to occur.
2021
During the three months endedMarch 31, 2021 , management identified launches of certainOrtho Dermatologics products which were not going to achieve their trajectories as forecasted once the social restrictions associated with the COVID-19 pandemic began to ease in theU.S. and offices of health care professionals could reopen. In addition, insurance coverage pressures within theU.S. continued to persist limiting patient access to topical acne and psoriasis products. In light of these developments, during the first quarter of 2021, the Company began taking steps to: (i) redirect its R&D spend to eliminate projects it had identified as high cost and high risk, (ii) redirect a portion of its marketing and product development outside theU.S. to geographies where there is better patient access and (iii) reduce its cost structure to be more competitive. As a result, during the three months endedMarch 31, 2021 , the Company revised its long-term forecasts for theOrtho Dermatologics reporting unit. Management believed that these events were indicators that there is less headroom as ofMarch 31, 2021 as compared to the headroom calculated on the date goodwill was last tested for impairment (October 1, 2020 ). Therefore, a quantitative fair value test for theOrtho Dermatologics reporting unit was performed. The quantitative fair value 79 -------------------------------------------------------------------------------- test utilized the Company's most recent cash flow projections as revised in the first quarter of 2021 to reflect the business changes previously discussed, including a range of potential outcomes, along with a long-term growth rate of 1.0% and a range of discount rates between 9.0% and 10.0%. Based on the quantitative fair value test, the carrying value of theOrtho Dermatologics reporting unit exceeded its fair value atMarch 31, 2021 , and the Company recognized a goodwill impairment of$469 million .
See Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim
Consolidated Financial Statements for further details related to our goodwill.
Asset Impairments, Including Loss on Assets Held for Sale
Asset impairments, including loss on assets held for sale were$15 million and$213 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$198 million . Asset impairments, including loss on assets held for sale for the nine months endedSeptember 30, 2022 includes: (i) impairments of$10 million , in aggregate, due to decreases in forecasted sales of certain product lines and (ii) impairments of$5 million , in aggregate, related to the discontinuance of certain product lines. Asset impairments, including loss on assets held for sale for the nine months endedSeptember 30, 2021 include: (i) impairments of$105 million , in aggregate, due to decreases in forecasted sales of certain product lines, (ii) adjustments of$88 million to the loss on assets held for sale in connection with the Amoun Sale and (iii) impairments of$20 million , in aggregate, related to the discontinuance of certain product lines.
See Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim
Consolidated Financial Statements for further details related to our intangible
assets.
Restructuring, Integration, Separation and IPO Costs
Restructuring, integration, separation and IPO costs were$58 million and$29 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$29 million .
Restructuring and Integration Costs
Restructuring and integration costs were$28 million and$9 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$19 million . The Company continues to evaluate opportunities to streamline its operations and identify additional cost savings globally. Although a specific plan does not exist at this time, the Company may identify and take additional exit and cost-rationalization restructuring actions in the future, the costs of which could be material. Separation and IPO Costs Separation and IPO costs were$30 million and$20 million for the nine months endedSeptember 30, 2022 and 2021, respectively. The extent and timing of future charges of these costs to complete the B+L Separation cannot be reasonably estimated at this time and could be material.
See Note 5, "RESTRUCTURING, INTEGRATION, SEPARATION AND IPO COSTS" to our
unaudited interim Consolidated Financial Statements for further details
regarding these actions.
Other Expense (Income), Net
Other expense (income), net for the nine months ended
2021 consists of the following:
Nine Months Ended
September 30,
(in millions) 2022 2021
Litigation and other matters $ 7 $ 320
Acquisition-related contingent consideration 2
8
Gain on sale of assets, net (3)
(2)
Acquired in-process research and development costs 1 3
Other, Net (1) -
$ 6 $ 329
Litigation and other matters for the nine months ended September 30, 2021 ,
included charges for adjustments related to the Glumetza Antitrust Litigation,
partially offset by insurance recoveries of $213 million related to certain
litigation matters. See Note 18, "LEGAL PROCEEDINGS" to our unaudited interim
Consolidated Financial Statements for further details.
80
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Non-Operating Income and Expense
Interest Expense
Interest expense was$1,157 million and$1,083 million and included non-cash amortization and write-offs of debt premiums, discounts and deferred issuance costs of$86 million and$42 million for the nine months endedSeptember 30, 2022 and 2021, respectively. Interest expense increased$74 million , or 7%, primarily due to higher interest rates partially offset by lower outstanding principal balances. The weighted average stated rate of interest as ofSeptember 30, 2022 and 2021 was 7.24% and 5.91%, respectively. The increase in the weighted average stated rate of interest of 133 bps is primarily attributable to the New Secured Notes. Due to the accounting treatment for the New Secured Notes, interest expense in the Company's financial statements in future periods will not be representative of the weighted average stated rate of interest.
Gain (Loss) on Extinguishment of Debt
The gain on extinguishment of debt was
million
The gain on extinguishment of debt for the nine months endedSeptember 30, 2022 includes: (i) the gain associated with the Exchange Offer of$570 million and (ii) the gains associated with the early retirement of certain senior unsecured notes of$176 million discussed below, partially offset by$63 million of losses associated with the refinancing and modification to certain debt obligations completed in connection with the B+L IPO, as discussed in further detail below, under "- Liquidity and Capital Resources - Liquidity and Debt" and represents the differences between the amounts paid to settle the extinguished debt and its carrying value. DuringJune 2022 , through a series of transactions we repurchased and retired, outstanding senior unsecured notes with an aggregate par value of$481 million in the open market for approximately$300 million using: (i) the net proceeds from the partial exercise of the over-allotment option in the B+L IPO by the underwriters, after deducting underwriting commissions, (ii) amounts available under our revolving credit facility and (iii) cash on hand. The senior unsecured notes retired had maturities ofJanuary 2028 throughFebruary 2031 and had a weighted average interest rate of approximately 5.35%. As a result of these transactions, we recognized a gain on the extinguishment of debt of approximately$176 million , net of write offs of debt premiums, discounts and deferred issuance costs, representing the differences between the amounts paid to retire the senior unsecured notes and their carrying value. The loss on extinguishment of debt of$62 million for the nine months endedSeptember 30, 2021 is primarily associated with refinancing transactions during the nine months endedSeptember 30, 2021 and represents the differences between the amounts paid to settle the extinguished debt and its carrying value.
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated
Financial Statements for further details.
Foreign Exchange and Other
Foreign exchange and other was a gain of$4 million and$11 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an unfavorable net change of$7 million primarily due to: (i) translation gains/losses on intercompany loans and third-party liabilities and (ii) the gain/loss due to foreign currency exchange contracts.
Income Taxes
Provision for income taxes was$30 million as compared to a Benefit from income taxes of$36 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an unfavorable change of$66 million . Our effective income tax rate for the nine months endedSeptember 30, 2022 differs from the statutory Canadian income tax rate primarily due to: (i) the tax provision generated from our annualized mix of earnings by jurisdiction, (ii) the recording of valuation allowance on entities for which no tax benefit of losses is expected and (iii) the discrete treatment of certain tax matters, primarily related to: (a) a net income tax benefit associated with certain legal settlements, (b) changes in uncertain tax positions, (c) tax provision related to potential and recognized withholding tax on intercompany dividends, (d) adjustments to book to income tax provisions and (e) adjustments to the tax deduction for stock compensation. Our effective income tax rate for the nine months endedSeptember 30, 2021 differs from the statutory Canadian income tax rate primarily due to: (i) the tax benefit generated from our annualized mix of earnings by jurisdiction, (ii) the recording of valuation allowance on entities for which no tax benefit of losses is expected and (iii) the discrete treatment of certain tax matters, primarily related to: (a) net income tax benefit associated with certain legal settlements, (b) tax provision 81 -------------------------------------------------------------------------------- related to potential and recognized withholding tax on intercompany dividends, (c) changes in uncertain tax positions, (d) adjustments for book to income tax return provisions and (e) a tax deduction for stock compensation.
See Note 16, "INCOME TAXES" to our unaudited interim Consolidated Financial
Statements for further details.
Reportable Segment Revenues and Profits
The following table presents segment revenues, segment revenues as a percentage of total revenues, and the year-over-year changes in segment revenues for the nine months endedSeptember 30, 2022 and 2021. The following table also presents segment profits, segment profits as a percentage of segment revenues and the year-over-year changes in segment profits for the nine months endedSeptember 30, 2022 and 2021.
Nine Months Ended
2022 2021 Change (in millions) Amount Pct. Amount Pct. Amount Pct. Segment Revenues Salix$ 1,509 25 %$ 1,515 24 %$ (6) < 1% International 727 12 % 890 14 % (163) (18) % Solta Medical 201 3 % 219 4 % (18) (8) % Diversified Products 722 13 % 850 14 % (128) (15) % Bausch + Lomb 2,772 47 % 2,764 44 % 8 <1% Total revenues$ 5,931 100 %$ 6,238 100 %$ (307) (5) % Segment Profits / Segment Profit Margins Salix$ 1,067 71 %$ 1,074 71 %$ (7) < 1% International 242 33 % 304 34 % (62) (20) % Solta Medical 88 44 % 120 55 % (32) (27) % Diversified Products 450 62 % 547 64 % (97) (18) % Bausch + Lomb 640 23 % 699 25 % (59) (8) % Total segment profits$ 2,487 42 %$ 2,744 44 %$ (257) (9) % The following table presents organic revenue (non-GAAP) and the year-over-year changes in organic revenue (non-GAAP) for the nine months endedSeptember 30, 2022 and 2021 by segment. Organic revenues (non-GAAP) and organic growth (non-GAAP) rates are defined in the previous section titled "Reportable Segment Revenues and Profits". Nine Months Ended September 30, 2022 Nine Months Ended September 30, 2021 Change in Revenue Revenue Organic Revenue (Non-GAAP) as Changes in Organic Revenue as Divestitures Organic Revenue (in millions) Reported Exchange Rates (Non-GAAP) Reported and Discontinuations (Non-GAAP) Amount Pct. Salix$ 1,509 $ -$ 1,509 $ 1,515 $ -$ 1,515 $ (6) - % International 727 49 776 890 (163) 727 49 7 %Solta Medical 201 7 208 219 - 219 (11) (5) % Diversified Products 722 - 722 850 (2) 848 (126) (15) % Bausch + Lomb 2,772 130 2,902 2,764 (7) 2,757 145 5 % Total$ 5,931 $ 186 $ 6,117 $ 6,238 $ (172)$ 6,066 $ 51 1 % Salix Segment: Salix Segment Revenue The Salix segment includes the Xifaxan® product line. Revenues from our Xifaxan® product line accounted for approximately 80% of the Salix segment revenues for the nine months endedSeptember 30, 2022 and 2021, in each period. No other single product group represents 10% or more of the Salix segment product sales. The Salix segment revenue for the nine months endedSeptember 30, 2022 and 2021 was$1,509 million and$1,515 million , respectively, a decrease of$6 million , or < 1%. The decrease was primarily driven by decreases in volume of$85 million , primarily attributable to: (i) unfavorable inventory balancing of Xifaxan® by certain wholesalers and (ii) the impact of generic competition as certain 82
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products, such as Apriso® which lost exclusivity, partially offset by an
increase in net realized pricing of
Xifaxan® product line.
Salix Segment Profit The Salix segment profit for the nine months endedSeptember 30, 2022 and 2021 was$1,067 million and$1,074 million , respectively, a decrease of$7 million , or < 1%. The decrease was primarily driven by: (i) a decrease in contribution primarily attributable to the net decrease in revenues, as previously discussed, and (ii) higher selling, advertising and promotion expenses primarily associated with Xifaxan®, partially offset by lower litigation costs.
International Segment:
International Segment Revenue
The International segment has a diversified product line with no single product group representing 10% or more of its product sales. The International segment revenue was$727 million and$890 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$163 million , or 18%. The decrease was primarily attributable to: (i) the impact of divestitures and discontinuations of$163 million , primarily attributable to our divestiture of Amoun onJuly 26, 2021 and (ii) the unfavorable impact of foreign currencies of$49 million , primarily inEurope . These decreases were partially offset by: (i) an increase in net realized pricing of$24 million and (ii) an increase in volumes of$25 million . The increase in volumes is primarily attributable toEurope and was partially offset by charges for approximately$13 million of returns in connection with a change in certain distribution agreements representing a change in estimated future returns in one market, driven by lower estimated demand following the easing of local COVID-19 lockdown restrictions as well as a change of distributors.
International Segment Profit
The International segment profit for the nine months endedSeptember 30, 2022 and 2021 was$242 million and$304 million , respectively, a decrease of$62 million , or 20%. The decrease was primarily driven by the decrease in contribution primarily attributable to: (i) our divestiture of Amoun onJuly 26, 2021 , (ii) the unfavorable impact of foreign currencies and (iii) higher manufacturing variances, driven by inflationary pressures related to certain manufacturing costs. Solta Medical Segment: Solta Medical Segment Revenue TheSolta Medical segment includes the Thermage® product line, which accounted for approximately 76% of the Solta segment revenues for the nine months endedSeptember 30, 2022 . No other single product group represents 10% or more of the Solta segment revenues. TheSolta Medical segment revenue for the nine months endedSeptember 30, 2022 and 2021 was$201 million and$219 million , respectively, a decrease of$18 million , or 8%. The decrease was primarily attributable to: (i) a decrease in volumes of$24 million , primarily driven by the impact of the COVID-19 pandemic related shutdowns inChina and (ii) the unfavorable impact of foreign currencies of$7 million , partially offset by an increase in net realized pricing of$13 million .
Solta Medical Segment Profit
TheSolta Medical segment profit for the nine months endedSeptember 30, 2022 and 2021 was$88 million and$120 million , respectively, a decrease of$32 million , or 27%. The decrease is attributable to lower contribution primarily driven by an increase in R&D and the unfavorable impact of foreign currencies.
Diversified Products Segment:
Diversified Products Segment Revenue
The Diversified Products segment revenue for the nine months endedSeptember 30, 2022 and 2021 was$722 million and$850 million , respectively, a decrease of$128 million , or 15%. The decrease was primarily driven by: (i) a decrease in net realized pricing of$18 million and (ii) a decrease in volumes of$108 million . The decrease in volumes was primarily attributable to our Neurology and Generics businesses, including: (i) decreases in several products attributable to the non-recurring pandemic related government mail order programs in 2021 and (ii) the impacts of more generic competitors.
Diversified Products Segment Profit
The Diversified Products segment profit for the nine months endedSeptember 30, 2022 and 2021 was$450 million and$547 million , respectively, a decrease of$97 million , or 18% and was primarily driven by the decrease in revenues, as previously discussed. 83 --------------------------------------------------------------------------------
Bausch + Lomb Segment:
Bausch + Lomb Segment Revenue
The Bausch + Lomb segment revenue was$2,772 million and$2,764 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$8 million , or < 1%. The increase was primarily attributable to: (i) an increase in volumes across each of the Bausch + Lomb businesses of$113 million and (ii) an increase in net realized pricing of$32 million . The increase in volumes was primarily driven by: (i) the consumer eye care business, driven by: (a) increased demand for Lumify®, Biotrue® and PreserVision® and (b) the non-recurrence of a third-party supplier quality issue on the prior year revenues of certain consumer eye care products, as previously discussed, (ii) increased demand of consumables and intraocular lenses within the Surgical business and (iii) increased demand and new launches within theOphthalmic Pharmaceuticals business. These increases in volumes were partially offset by the impact of the COVID-19 pandemic during the first half of the year on the contact lens business inChina . The increases in revenue were partially offset by: (i) the unfavorable impact of foreign currencies across all international businesses of$130 million , primarily inEurope andAsia and (ii) the impact of divestitures and discontinuations of$7 million , related to the discontinuation of certain products. Bausch + Lomb Segment Profit The Bausch + Lomb segment profit for the nine months endedSeptember 30, 2022 and 2021 was$640 million and$699 million , respectively, a decrease of$59 million , or 8%. The decrease was primarily driven by: (i) higher selling expenses, primarily due to freight and (ii) higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of Daily SiHy lenses and, partially offset by the non-recurrence of prior year charges related to a quality issue at a third-party supplier, as previously discussed. These decreases were partially offset by the increase in revenues, as previously discussed.
LIQUIDITY AND CAPITAL RESOURCES
Cash Flows
Nine Months Ended September 30,
(in millions) 2022 2021 Change
Net income (loss) $ 198
Adjustments to reconcile net income (loss) to net cash
provided by operating activities
(1,027) 2,322 (3,349)
Cash (used in) provided by operating activities before
changes in operating assets and liabilities
(829) 1,313 (2,142) Changes in operating assets and liabilities (374) 89 (463) Net cash (used in) provided by operating activities (1,203) 1,402 (2,605) Net cash (used in) provided by investing activities (167) 489 (656) Net cash used in financing activities (198) (1,788) 1,590
Effect of exchange rate changes on cash, cash equivalents
and other
(54) (15) (39)
Net (decrease) increase in cash, cash equivalents,
restricted cash and other settlement deposits
(1,622) 88 (1,710) Cash, cash equivalents, restricted cash and other settlement deposits, beginning of period 2,119 1,816 303 Cash, cash equivalents, restricted cash and other settlement deposits, end of period$ 497 $ 1,904 $ (1,407) Operating Activities Net cash used in operating activities was$1,203 million for the nine months endedSeptember 30, 2022 , as compared to net cash provided by operating activities of$1,402 million for the nine months endedSeptember 30, 2021 , a decrease of$2,605 million . The decrease was attributable to: (i) the decrease in Cash provided by operating activities before changes in operating assets and liabilities and (ii) Changes in operating assets and liabilities. Cash used in operating activities before changes in operating assets and liabilities was$829 million for the nine months endedSeptember 30, 2022 as compared to cash provided by operating activities before changes in operating assets and liabilities of$1,313 million for the nine months endedSeptember 30, 2021 , a decrease of$2,142 million . The decrease is primarily attributable to: (i) payments of accrued legal settlements related to the Securities Class Action Settlement, the Glumetza Antitrust Litigation and a RICO class action matter paid during 2022, (ii) changes in business performance, (iii) the impact of our divestiture of Amoun onJuly 26, 2021 and (iv) an increase in payments for separation-related costs and IPO-related costs in 2022 as compared to 2021. 84 -------------------------------------------------------------------------------- As ofDecember 31, 2021 , Restricted cash and other settlement deposits included$1,210 million of payments into an escrow fund under the terms of Securities Class Action Settlement, which was subject to one objector's appeal of the final court approval of the agreement. The period to file a petition for an appeal with theU.S. Supreme Court expired onAugust 10, 2022 and the objector did not file such a petition. The expiration of this deadline means the Securities Class Action Settlement has become "final", as no more appeals can be filed. As a result, the Company's rights in the funds previously paid into the escrow account were extinguished in accordance with the terms of the Securities Class Action Settlement. Changes in operating assets and liabilities resulted in a net decrease in cash of$374 million for the nine months endedSeptember 30, 2022 , as compared to a net increase of$89 million for the nine months endedSeptember 30, 2021 , a decrease of$463 million . During the nine months endedSeptember 30, 2022 , Changes in operating assets and liabilities were negatively impacted by: (i) an increase in inventories of$194 million , (ii) the timing of other payments in the ordinary course of business of$154 million , driven in part by the impact of the interest payments made onSeptember 30, 2022 associated with the notes tendered in the Exchange Offer and (iii) increases in trade receivables of$26 million . During the nine months endedSeptember 30, 2021 , Changes in operating assets and liabilities was positively impacted by: (i) the timing of other payments in the ordinary course of business of$314 million and (ii) an increase in accrued interest due to timing of payments of$14 million and was partially offset by: (i) an increase in trade receivables of$177 million and (ii) an increase in inventories of$62 million .
Investing Activities
Net cash used in investing activities was$167 million for the nine months endedSeptember 30, 2022 and was primarily driven by Purchases of property, plant and equipment of$152 million . Net cash provided by investing activities was$489 million for the nine months endedSeptember 30, 2021 and was primarily driven by partial: (i) Proceeds from sale of assets and businesses, net of costs to sell of$669 million , which was primarily attributable to the Amoun sale and (ii) Interest settlements from cross-currency swaps of$23 million partially offset by Purchases of property, plant and equipment of$191 million .
Financing Activities
Net cash used in financing activities was$198 million for the nine months endedSeptember 30, 2022 and was primarily driven by: (i) the issuance of long-term debt, net of discounts, of$6,481 million related to theFebruary 2027 Secured Notes, 2027 Term Loan B Facility, draws on the 2027 Revolving Credit Facility and the B+L Term Loan Facility and (ii) net proceeds from the B+L IPO of$675 million , partially offset by the repayment of long-term debt of$7,224 million related to: (i) the repayment of the outstanding balance under our 2023 Revolving Credit Facility, (ii) the repayment of the outstanding balance of our 6.125% Senior Unsecured Notes, (iii) the repayment of the outstanding balances under our 2025 Term Loan B Facilities and (iv) the repurchase and retirement of certain outstanding senior unsecured notes in the open market with an aggregate par value of$481 million for approximately$300 million . Net cash used in financing activities was$1,788 million for the nine months endedSeptember 30, 2021 and was primarily driven by the repayments of debt of$3,200 million which consisted of: (i)$1,600 million of 7.00% Senior Secured Notes due 2024 as part of the 2021 Refinancing Transactions and (ii) the aggregate prepayments of$1,600 million using cash on hand, cash generated from operations and the net proceeds from the Amoun Sale. Issuance of long-term debt, net of discounts of$1,576 million primarily includes the proceeds of$1,580 million from the issuance of$1,600 million in principal amount of 4.875% Senior Secured Notes dueJune 2028 .
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated
Financial Statements for additional information regarding the financing
activities described above.
Liquidity and Debt Future Sources of Liquidity Our primary sources of liquidity are our cash and cash equivalents, cash collected from customers, funds as available from our revolving credit facility, issuances of long-term debt and issuances of equity and equity-linked securities. We believe these sources will be sufficient to meet our current liquidity needs for at least the twelve months following the issuance of this Form 10-Q. The Company regularly evaluates market conditions, its liquidity profile, and various financing alternatives for opportunities to enhance its capital structure. If opportunities are favorable, the Company may refinance, repurchase or exchange existing debt or issue equity or equity-linked securities. Cash, cash equivalents and restricted cash and other settlements as presented in the Consolidated Balance Sheet as ofSeptember 30, 2022 includes$297 million of cash, cash equivalents and restricted cash held by legal entities of Bausch + 85 -------------------------------------------------------------------------------- Lomb. Cash held by Bausch + Lomb legal entities and any future cash from the operations, investing and financing activities of Bausch + Lomb, is expected to be retained by Bausch + Lomb entities and are generally not available to support the operations, investing and financing activities of other legal entities, includingBausch Health unless paid as a dividend which would be determined by the Board of Directors of Bausch + Lomb and paid pro rata to Bausch + Lomb's shareholders. Long-term Debt Long-term debt, net of unamortized premiums, discounts and issuance costs was$21,215 million and$22,654 million as ofSeptember 30, 2022 andDecember 31, 2021 , respectively. Aggregate contractual principal amounts due under our debt obligations were$19,574 million and$22,870 million as ofSeptember 30, 2022 andDecember 31, 2021 , respectively, a decrease of$3,296 million . OnSeptember 30, 2022 , we closed the Exchange Offer, pursuant to which existing unsecured senior notes as set forth in the table below (collectively, the "Existing Unsecured Senior Notes") with an aggregate outstanding principal balance of$5,594 million were exchanged for$3,125 million in aggregate principal balance of New Secured Notes (as defined below). The Exchange Offer reduced our then aggregate outstanding principal debt balance by$2,469 million . In accordance withU.S. GAAP, we recognized a portion of this reduction as a gain of$570 million , net of third-party fees and the write-off of the unamortized debt discounts and issuance costs related to the Existing Unsecured Senior Notes. In accordance withU.S. GAAP, we were required to record the balance of the reduction in our debt balance,$1,835 million , as a premium on the New Secured Notes. This premium will be reduced as we make interest payments on the New Secured Notes in the amounts as presented in the previously provided table under the caption "Exchange Offer". Due to the accounting treatment for the New Secured Notes, interest expense in the Company's financial statements in future periods will not be representative of their stated rates of interest.
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated
Financial Statements for further details on the accounting for the Exchange
Offer.
The secured notes issued in the Exchange Offer consist of: (i)$1,774 million in aggregate principal amount of new 11.00% First Lien Secured Notes due 2028 (the "11.00% First Lien Secured Notes") issued by the Company, (ii)$352 million in aggregate principal amount of new 14.00% Second Lien Secured Notes due 2030 (the "14.00% Second Lien Secured Notes", and, together with the 11.00% First Lien Secured Notes, the "New BHC Secured Notes") issued by the Company and (iii)$999 million in aggregate principal amount of new 9.00% Senior Secured Notes due 2028 (the "9.00% Intermediate Holdco Secured Notes", and, together with the New BHC Secured Notes, the "New Secured Notes") issued by 1375209B.C. Ltd. ("Intermediate Holdco"), an existing wholly-owned unrestricted subsidiary of the Company that holds 38.6% of the issued and outstanding common shares of Bausch + Lomb. The aggregate principal amounts of the Existing Unsecured Senior Notes that were validly tendered and accepted by the Company in the Exchange Offer are set forth below: Total Aggregate Percentage of Outstanding Principal Amount Existing Notes Validly (in millions) Validly Tendered Tendered
9.00% Senior Notes due 2025 $ 541 36 %
9.25% Senior Notes due 2026 752 50 %
8.50% Senior Notes due 2027 1,099 63 %
7.00% Senior Notes due 2028 540 72 %
5.00% Senior Notes due 2028 710 60 %
7.25% Senior Notes due 2029 373 50 %
6.25% Senior Notes due 2029 540 38 %
5.00% Senior Notes due 2029 371 44 %
5.25% Senior Notes due 2030 332 28 %
5.25% Senior Notes due 2031 336 37 %
Total $ 5,594
86
-------------------------------------------------------------------------------- The Exchange Offer reduced the principal balances of our outstanding debt obligations by$2,469 million . The Exchange Offer also had the effect of extending the maturities of approximately$2,400 million of aggregate principal balances of senior notes coming due during the years 2025 through 2027 out to the years 2028 and 2030. Additionally, we have reduced our estimated debt service requirements of principal and interest over the 12 months endingSeptember 30, 2023 by approximately$65 million . In addition to the Exchange Offer, we made debt repayments and completed refinancing transactions during the nine months endedSeptember 30, 2022 that reduced our outstanding debt obligations and extended certain maturities of our remaining debt obligations as previously discussed under "- Liquidity and Capital Resources - Cash Flows - Financing Activities".
Senior Secured Credit Facilities
Senior Secured Credit Facilities under the 2018 Restated Credit Agreement
OnJune 1, 2018 , the Company and certain of its subsidiaries as guarantors entered into the "Senior Secured Credit Facilities" under the Company's Fourth Amended and Restated Credit and Guaranty Agreement, as amended by the First Incremental Amendment to the Restated Credit Agreement, dated as ofNovember 27, 2018 (the "2018 Restated Credit Agreement") with a syndicate of financial institutions and investors as lenders. Prior to the 2022 Amended Credit Agreement (as defined below), the 2018 Restated Credit Agreement provided for a revolving credit facility of$1,225 million , maturing on the earlier ofJune 1, 2023 and the date that is 91 calendar days prior to the scheduled maturity of indebtedness for borrowed money of the Company andBausch Health Americas, Inc. ("BHA") in an aggregate principal amount in excess of$1,000 million (the "2023 Revolving Credit Facility") and term loan facilities of original principal amounts of$4,565 million and$1,500 million , maturing inJune 2025 (the "June 2025 Term Loan B Facility") andNovember 2025 (the "November 2025 Term Loan B Facility"), respectively.
Senior Secured Credit Facilities under the 2022 Amended Credit Agreement
OnMay 10, 2022 , the Company and certain of its subsidiaries as guarantors entered into a Second Amendment (the "Second Amendment") to the Fourth Amended and Restated Credit and Guaranty Agreement (as amended by the Second Amendment, the "2022 Amended Credit Agreement"). The 2022 Amended Credit Agreement provides for a new term loan facility with an aggregate principal amount of$2,500 million (the "2027 Term Loan B Facility") maturing onFebruary 1, 2027 and a new revolving credit facility of$975 million (the "2027 Revolving Credit Facility") that will mature on the earlier ofFebruary 1, 2027 and the date that is 91 calendar days prior to the scheduled maturity of indebtedness for borrowed money of the Company and BHA in an aggregate principal amount in excess of$1,000 million . Borrowings under the 2027 Revolving Credit Facility can be made inU.S. dollars, Canadian dollars or Euros. After giving effect to the Second Amendment, the 2023 Revolving Credit Facility,June 2025 Term Loan B Facility andNovember 2025 Term Loan B Facility were refinanced (such refinancing, the "Credit Agreement Refinancing"), along with certain of the Company's existing senior notes, using net proceeds from the borrowings under the 2027 Term Loan B Facility, the B+L IPO and the B+L Debt Financing (as defined below) and available cash on hand. As ofSeptember 30, 2022 , the Company had drawn$450 million on the 2027 Revolving Credit Facility. Borrowings under the 2027 Term Loan B Facility bear interest at a rate per annum equal to, at the Company's option, either: (a) a forward-looking term rate determined by reference to the financing rate for borrowingU.S. dollars overnight collateralized byU.S. Treasury securities ("term SOFR rate") for the interest period relevant to such borrowing or (b) a base rate determined by reference to the highest of: (i) the prime rate (as defined in the 2022 Amended Credit Agreement), (ii) the federal funds effective rate plus 1/2 of 1.00% and (iii) the term SOFR rate for a period of one month plus 1.00% (or if such rate shall not be ascertainable, 1.50%) (provided, however that the term SOFR rate with respect to the 2027 Term Loan B Facility shall at no time be less than 0.50% per annum), in each case, plus an applicable margin. Borrowings under the 2027 Revolving Credit Facility in: (i)U.S. dollars bear interest at a rate per annum equal to, at the Company's option, either: (a) the term SOFR rate (subject to a floor of 0.00% per annum) or (b) aU.S. dollar base rate, (ii) Canadian dollars bear interest at a rate per annum equal to, at the Company's option, either: (a) a Canadian dollar offer rate or (b) a Canadian dollar prime and (iii) euros bear interest at a rate per annum equal to a term benchmark rate determined by reference to the cost of funds for euro deposits ("EURIBOR") for the interest period relevant to such borrowing (subject to a floor of 0.00% per annum), in each case, plus an applicable margin. Term SOFR rate loans are subject to a credit spread adjustment ranging from 0.10%-0.25%.The applicable interest rate margin for borrowings under the 2027 Term Loan B Facility is 5.25% for term SOFR rate loans and 4.25% forU.S. dollar base rate loans. The applicable interest rate margin for borrowings under the 2027 Revolving Credit Facility ranges from 4.75% to 5.25% for term SOFR rate loans, BA rate loans and EURIBOR loans and 3.75% to 4.25% forU.S. dollar base rate loans and Canadian prime rate loans. In addition, the Company is required to pay commitment fees of 0.25%-0.50% per annum with respect to the unutilized commitments under the 2027 Revolving Credit Facility, payable quarterly in arrears. The Company also is required to pay: (i) 87 -------------------------------------------------------------------------------- letter of credit fees on the maximum amount available to be drawn under all outstanding letters of credit in an amount equal to the applicable margin on term SOFR rate borrowings under the 2027 Revolving Credit Facility on a per annum basis, payable quarterly in arrears, (ii) customary fronting fees for the issuance of letters of credit and (iii) agency fees. Subject to certain exceptions and customary baskets set forth in the 2022 Amended Credit Agreement, the Company is required to make mandatory prepayments of the loans under the Senior Secured Credit Facilities under certain circumstances, including from: (i) 100% of the net cash proceeds of insurance and condemnation proceeds for property or asset losses (subject to reinvestment rights and net proceeds thresholds), (ii) 100% of the net cash proceeds from the incurrence of debt (other than permitted debt as described in the 2022 Amended Credit Agreement), (iii) 50% of Excess Cash Flow (as defined in the 2022 Amended Credit Agreement) subject to decrease based on leverage ratios and subject to a threshold amount and (iv) 100% of net cash proceeds from asset sales (subject to reinvestment rights and net proceeds thresholds). These mandatory prepayments may be used to satisfy future amortization. The amortization rate for the 2027 Term Loan B Facility is 5.00% per annum, or$125 million , payable in quarterly installments beginning onSeptember 30, 2022 . The Company may direct that prepayments be applied to such amortization payments in order of maturity. As ofSeptember 30, 2022 , the remaining mandatory quarterly amortization payments for the 2027 Term Loan B Facility were$531 million throughDecember 2026 . The 2022 Amended Credit Agreement permits the incurrence of incremental credit facility borrowings up to the greater of$1,000 million and 40% of Consolidated Adjusted EBITDA (non-GAAP) (as defined in the 2022 Amended Credit Agreement), subject to customary terms and conditions, as well as the incurrence of additional incremental credit facility borrowings subject to, in the case of secured debt, a secured leverage ratio of not greater than 3.50:1.00, and, in the case of unsecured debt, either a total leverage ratio of not greater than 6.50:1.00 or an interest coverage ratio of not less than 2.00:1.00. The 2022 Amended Credit Agreement provides that Bausch + Lomb shall initially be a "restricted" subsidiary subject to the terms of the 2022 Amended Credit Agreement covenants, but does not require Bausch + Lomb to guarantee the obligations under the 2022 Amended Credit Agreement. The 2022 Amended Credit Agreement permits the Company to designate Bausch + Lomb as an "unrestricted" subsidiary under the 2022 Amended Credit Agreement and no longer subject to the terms of the covenants thereunder provided that no event of default is continuing or will result from such designation and the total leverage ratio of Remainco (as defined in the 2022 Amended Credit Agreement) will not be greater than 7.60:1.00 on a pro forma basis. The Credit Agreement Refinancing contains provisions designed to facilitate the B+L Separation.
Senior Secured Credit Facilities under the B+L Credit Agreement
OnMay 10, 2022 , Bausch + Lomb entered into a credit agreement (the "B+L Credit Agreement", and the credit facilities thereunder, the "B+L Credit Facilities") providing for a term loan of$2,500 million with a five-year term to maturity (the "B+L Term Facility") and a five-year revolving credit facility of$500 million (the "B+L Revolving Credit Facility" and such financing, the "B+L Debt Financing"). The B+L Credit Facilities are secured by substantially all of the assets of Bausch + Lomb and its material, wholly-owned Canadian,U.S. , Dutch and Irish subsidiaries, subject to certain exceptions. The term loan is denominated inU.S. dollars, and borrowings under the revolving credit facility will be made available inU.S. dollars, euros, pounds sterling and Canadian dollars. As ofSeptember 30, 2022 , the principal amount outstanding under the B+L Term Facility was$2,494 million and$2,442 million net of issuance costs. The B+L Revolving Credit Facility remained undrawn. Borrowings under the B+L Revolving Credit Facility in: (i)U.S. dollars bear interest at a rate per annum equal to, at Bausch + Lomb's option, either: (a) a term Secured Overnight Financing Rate ("SOFR")-based rate or (b) aU.S. dollar base rate, (ii) Canadian dollars bear interest at a rate per annum equal to, at Bausch + Lomb's option, either: (a) Canadian Dollar Offered Rate ("CDOR") or (b) a Canadian dollar prime rate, (iii) euros bear interest at a rate per annum equal to EURIBOR and (iv) pounds sterling bear interest at a rate per annum equal to Sterling Overnight Index Average ("SONIA") (provided, however, that the term SOFR-based rate, CDOR, EURIBOR and SONIA shall be no less than 0.00% per annum at any time and theU.S. dollar base rate and the Canadian dollar prime rate shall be no less than 1.00% per annum at any time), in each case, plus an applicable margin. Term SOFR-based loans are subject to a credit spread adjustment of 0.10%. The applicable interest rate margins for borrowings under the B+L Revolving Credit Facility are: (i) between 0.75% to 1.75% with respect toU.S. dollar base rate or Canadian dollar prime rate borrowings and between 1.75% to 2.75% with respect to term SOFR, EURIBOR, SONIA or CDOR borrowings based on Bausch + Lomb's total net leverage ratio and (ii) after: (x) Bausch + Lomb's senior unsecured non-credit-enhanced long term indebtedness for borrowed money receives an investment grade rating from at least two of S&P, Moody's and Fitch and (y) the B+L Term Facility has been repaid in full in cash (the "IG Trigger"), between 0.015% to 0.475% with respect toU.S. dollar base rate or Canadian dollar prime rate borrowings and between 1.015% to 1.475% with respect to SOFR, EURIBOR, SONIA or CDOR borrowings based on 88 -------------------------------------------------------------------------------- Bausch + Lomb's debt rating. In addition, Bausch + Lomb is required to pay commitment fees of 0.25% per annum in respect of the unutilized commitments under the B+L Revolving Credit Facility, payable quarterly in arrears until the IG Trigger and a facility fee between 0.110% to 0.275% of the total revolving commitments, whether used or unused, based on Bausch + Lomb's debt rating and payable quarterly in arrears. Bausch + Lomb is also required to pay letter of credit fees on the maximum amount available to be drawn under all outstanding letters of credit in an amount equal to the applicable margin on SOFR borrowings under the B+L Revolving Credit Facility on a per annum basis, payable quarterly in arrears, as well as customary fronting fees for the issuance of letters of credit and agency fees. Borrowings under the B+L Term Facility bear interest at a rate per annum equal to, at Bausch + Lomb's option, either (i) a term SOFR-based rate plus an applicable margin of 3.25% or (ii) a US dollar base rate plus an applicable margin of 2.25% (provided, however, that the term SOFR-based rate shall be no less than 0.50% per annum at any time and theU.S. dollar base rate shall not be lower than 1.50% per annum at any time). Term SOFR-based loans are subject to a credit spread adjustment of 0.10%. Subject to certain exceptions and customary baskets set forth in the B+L Credit Agreement, Bausch + Lomb is required to make mandatory prepayments of the loans under the B+L Term Facility under certain circumstances, including from: (i) 100% of the net cash proceeds of insurance and condemnation proceeds for property or asset losses (subject to reinvestment rights, decrease based on leverage ratios and net proceeds threshold), (ii) 100% of the net cash proceeds from the incurrence of debt (other than permitted debt as described in the B+L Credit Agreement), (iii) 50% of Excess Cash Flow (as defined in the B+L Credit Agreement) subject to decrease based on leverage ratios and subject to a threshold amount and (iv) 100% of net cash proceeds from asset sales (subject to reinvestment rights, decrease based on leverage ratios and net proceeds threshold). These mandatory prepayments may be used to satisfy future amortization. The amortization rate for the B+L Term Facility is 1.00% per annum and the first installment is payable onSeptember 30, 2022 . Bausch + Lomb may direct that prepayments be applied to such amortization payments in order of maturity. Provided, however, that the term SOFR-based rate shall be no less than 0.50% per annum at any time and theU.S. dollar base rate shall not be lower than 1.50% per annum at any time. Term SOFR-based loans are subject to a credit spread adjustment of 0.10%.
Senior Secured Notes
The Senior Secured Notes (as defined in Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated Financial Statements) are guaranteed by each of the Company's subsidiaries that is a guarantor under the 2022 Amended Credit Agreement and existing Senior Unsecured Notes (together, the "Note Guarantors"). The Senior Secured Notes and the guarantees related thereto are senior obligations and are secured, subject to permitted liens and certain other exceptions, by the same first priority liens that secure the Company's obligations under the 2022 Amended Credit Agreement under the terms of the indentures governing the Senior Secured Notes. The Senior Secured Notes and the guarantees rank equally in right of repayment with all of the Company's and Note Guarantors' respective existing and future unsubordinated indebtedness and senior to the Company's and Note Guarantors' respective future subordinated indebtedness. The Senior Secured Notes and the guarantees related thereto are effectively pari passu with the Company's and the Note Guarantors' respective existing and future indebtedness secured by a first priority lien on the collateral securing the Senior Secured Notes and effectively senior to the Company's and the Note Guarantors' respective existing and future indebtedness that is unsecured, including the existing Senior Unsecured Notes, or that is secured by junior liens, in each case to the extent of the value of the collateral. In addition, the Senior Secured Notes are structurally subordinated to: (i) all liabilities of any of the Company's subsidiaries that do not guarantee the Senior Secured Notes and (ii) any of the Company's debt that is secured by assets that are not collateral. Upon the occurrence of a change in control (as defined in the indentures governing the Senior Secured Notes), unless the Company has exercised its right to redeem all of the notes of a series, holders of the Senior Secured Notes may require the Company to repurchase such holder's notes, in whole or in part, at a purchase price equal to 101% of the principal amount thereof plus accrued and unpaid interest. New BHC Secured Notes The 11.00% First Lien Secured Notes mature onSeptember 30, 2028 , and accrue interest at 11.00% per year, payable semi-annually in arrears on eachMarch 30 andSeptember 30 . The 11.00% First Lien Secured Notes are redeemable, in whole or in part, at any time at a price equal to 100% of the principal amount thereof, plus accrued and unpaid interest to, but not including the date of redemption plus a "make-whole" premium as described in the 11.00% First Lien Secured Notes indenture.
The 14.00% Second Lien Secured Notes mature on
interest at 14.00% per year, payable semi-annually in arrears on each
and
89 -------------------------------------------------------------------------------- whole or in part, at any time on or afterOctober 15, 2025 at the applicable redemption prices set forth in the 14.00% Second Lien Secured Notes indenture. In addition, some or all of the 14.00% Second Lien Secured Notes may be redeemed prior toOctober 15, 2025 at a price equal to 100% of the principal amount thereof, plus accrued and unpaid interest to, but not including, the date of redemption plus a "make-whole" premium as described in the 14.00% Second Lien Secured Notes indenture. At any time prior toOctober 15, 2025 , up to 40% of the aggregate principal amount of the 14.00% Second Lien Secured Notes may be redeemed with the net proceeds of certain equity offerings at the redemption price set forth in the 14.00% Second Lien Secured Notes indenture.
9.00% Intermediate Holdco Secured Notes
The 9.00% Intermediate Holdco Secured Notes mature on
accrue interest at 9.00% per year, payable semi-annually in arrears on each
redeemable at the option of Intermediate Holdco, in whole or in part, at any
time, at the redemption prices set forth in the 9.00% Intermediate Holdco
Secured Notes indenture.
The 9.00% Intermediate Holdco Secured Notes are general senior secured obligations of Intermediate Holdco and secured by first priority liens (subject to permitted liens and certain other exceptions) on substantially all of the assets of Intermediate Holdco, which as ofSeptember 30, 2022 were comprised of 38.6% of the issued and outstanding common shares of Bausch + Lomb Corporation. The 9.00% Intermediate Holdco Secured Notes and Intermediate Holdco's other obligations under the indenture governing such notes are not obligations or responsibilities of, or guaranteed by, the Company, Bausch + Lomb or any of their respective affiliates or subsidiaries (other than the issuer IntermediateHoldco ). The sole recourse of the holders of the 9.00% Intermediate Holdco Secured Notes under the 9.00% Intermediate Holdco Secured Notes and the indenture governing such notes is limited to Intermediate Holdco and its assets. The aggregate principal amount of our Senior Secured Notes and 9.00% Intermediate Holdco Secured Notes as ofSeptember 30, 2022 andDecember 31, 2021 was$7,975 million and$3,850 million , respectively, an increase of$4,125 million . The increase is attributable to: (i) the issuance of the New BHC Secured Notes and the issuance of the 9.00% Intermediate Holdco Secured Notes in connection with the Exchange Offer as previously discussed and (ii) the issuance of theFebruary 2027 Secured Notes as previously discussed.
Senior Unsecured Notes
The Senior Unsecured Notes (as defined in Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated Financial Statements) issued by the Company are the Company's senior unsecured obligations and are jointly and severally guaranteed on a senior unsecured basis by each of its subsidiaries that is a guarantor under the 2022 Amended Credit Agreement. The Senior Unsecured Notes issued by BHA are senior unsecured obligations of BHA and are jointly and severally guaranteed on a senior unsecured basis by the Company and each of its subsidiaries (other than BHA) that is a guarantor under the 2022 Amended Credit Agreement. Future subsidiaries of the Company and BHA, if any, may be required to guarantee the Senior Unsecured Notes. In connection with the closing of the B+L IPO, the discharge of theApril 2025 Unsecured Notes Indenture and the related release under the 2022 Amended Credit Agreement described above, the guarantees and related security provided by Bausch + Lomb and its subsidiaries in respect of the existing senior notes of the Company and BHA were released. On a non-consolidated basis, the non-guarantor subsidiaries had total assets of$12,266 million and total liabilities of$5,338 million as ofSeptember 30, 2022 , and revenues of$3,044 million and operating income of$50 million for the nine months endedSeptember 30, 2022 . If the Company experiences a change in control, the Company may be required to make an offer to repurchase each series of Senior Unsecured Notes, in whole or in part, at a purchase price equal to 101% of the aggregate principal amount of the Senior Unsecured Notes repurchased, plus accrued and unpaid interest. The aggregate principal amount of our Senior Unsecured Notes as ofSeptember 30, 2022 andDecember 31, 2021 was$6,175 million and$14,900 million , respectively, a decrease of$8,725 million , attributable to: (i) Existing Unsecured Notes of$5,594 million validly tendered and accepted in connection with the Exchange Offer, (ii) the redemption in full of$2,650 million ofApril 2025 Unsecured Notes and (iii) the repurchase and retirement of certain outstanding Senior Unsecured Notes in the open market with an aggregate par value of approximately$481 million for$300 million .
Availability Under Revolving Credit Facilities
As of the date of this filing,
outstanding borrowings,
and approximately
Revolving Credit Facility.
As of the date of this filing,
borrowings,
million
the
90
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payment of a dividend, which would be determined by the Board of Directors of
Bausch + Lomb and paid pro rata to Bausch + Lomb's shareholders, proceeds from
the B+L Revolving Credit Facility are not available to fund the operations,
investing and financing activities of Bausch Health .
Covenant Compliance
Any inability to comply with the covenants under the terms of our 2022 Amended Credit Agreement, B+L Credit Agreement, Senior Secured Notes indentures or Senior Unsecured Notes indentures could lead to a default or an event of default for which we may need to seek relief from our lenders and noteholders in order to waive the associated default or event of default and avoid a potential acceleration of the related indebtedness or cross-default or cross-acceleration to other debt. There can be no assurance that we would be able to obtain such relief on commercially reasonable terms or otherwise and we may be required to incur significant additional costs. In addition, the lenders under our 2022 Amended Credit Agreement and B+L Credit Agreement, holders of our Senior Secured Notes and holders of our Senior Unsecured Notes may impose additional operating and financial restrictions on us as a condition to granting any such waiver. As ofSeptember 30, 2022 , the Company was in compliance with its financial maintenance covenant related to its outstanding debt. The Company, based on its current forecast, expects to remain in compliance with the financial maintenance covenant and meet its debt service obligations for at least the twelve months following the date of issuance of this Form 10-Q. The Company continues to take steps to seek to improve its operating results to ensure continual compliance with its financial maintenance covenant and take other actions to reduce its debt levels to align with the Company's long-term strategy. The Company may consider taking other actions, including divesting other businesses, refinancing debt and issuing equity or equity-linked securities including secondary offerings of the common shares of Bausch + Lomb, as deemed appropriate, to provide additional coverage in complying with the financial maintenance covenant and meeting its debt service obligations.
Weighted Average Interest Rate
The accounting for the Exchange Offer results in the New Secured Notes being carried at a premium relative to their principal amount and will result in no interest expense to be recorded in our financial statements for a significant portion of the New Secured Notes. Therefore, interest expense recorded in our consolidated financial statements will differ significantly from the contractual interest rates of the New Secured Notes. The weighted average interest rate of our debt as reported in our financial statements and the weighted average stated interest rate was 5.67% and 7.24%, respectively, as ofSeptember 30, 2022 . The weighted average stated rate of interest of the Company's outstanding debt as ofDecember 31, 2021 was 5.88%. The increase in the weighted average stated rate of interest of 136 bps is due to the issuance of the New Secured Notes in connection with the Exchange Offer.
See Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated
Financial Statements for further details.
Focus on Capitalization of the Post-separation Entities
In connection with the B+L Separation, we have emphasized that it is important
that the post-separation entities be well-capitalized, with appropriate leverage
and with access to additional capital, if and when needed, to provide each
entity with the ability to independently allocate capital to areas that will
strengthen their own competitive positions in their respective lines of business
and position each entity for sustainable growth. Therefore, we see the
appropriate capitalization and leverage of these businesses post-separation as a
key to bringing out the maximum value across our portfolio of assets and it
continues to be a primary objective of our plan of separation.
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Credit Ratings
As ofNovember 3, 2022 , the credit ratings and outlook from Moody's,Standard & Poor's ("S&P's") and Fitch for certain outstanding obligations of the Company were as follows: Bausch Health Companies Inc. Bausch + Lomb Corporation Senior Senior Secured Unsecured Senior SecuredRating Agency Corporate Rating Rating Rating Outlook Corporate Rating Rating Outlook Moody's Caa2 Caa1 Ca Negative B1 NegativeStandard & Poor's CCC+ B- CCC Stable CCC+ CCC+ Positive Fitch CCC B CC No Outlook B- BB- Rating Watch EvolvingBausch Health Companies Inc. - OnSeptember 30, 2022 , Moody's downgraded all ratings to: a corporate rating of Caa2, a senior secured rating of Caa1 and a senior unsecured rating of Ca. OnOctober 4, 2022 , S&P lowered its senior secured rating to B-. OnOctober 6, 2022 , Fitch downgraded all ratings to: a corporate rating of CCC, a senior secured rating of B and a senior unsecured rating of CC. These downgrades were a result of the Exchange Offer (see Note 10, "FINANCING ARRANGEMENTS" to our unaudited interim Consolidated Financial Statements). Bausch + Lomb Corporation - Bausch + Lomb is a restricted subsidiary under the 2022 Amended Credit Agreement and related indentures and will remain a restricted subsidiary untilBausch Health designates Bausch + Lomb as "unrestricted", which is expected to occur at or prior to the distribution anticipated under the proposed B+L Separation. We expect Bausch + Lomb's credit ratings could be capped to those of the Company, until we designate Bausch + Lomb as "unrestricted". InOctober 2022 , S&P changed its outlook assigned to Bausch + Lomb from developing to positive. InOctober 2022 , Fitch lowered its rating two notches to a B- corporate rating as well as lowered the senior secured rating two notches to BB-. These downgrades were made simultaneously with the downgrades to the credit ratings ofBausch Health , Bausch + Lomb's parent company.
Any downgrade in our corporate credit ratings or other credit ratings may
increase our cost of borrowing and may negatively impact our ability to raise
additional debt capital.
OFF-BALANCE SHEET ARRANGEMENTS AND CONTRACTUAL OBLIGATIONS
We have no off-balance sheet arrangements that have a material current effect or
that are reasonably likely to have a material effect on our results of
operations, financial condition, capital expenditures, liquidity or capital
resources.
A substantial portion of our cash requirements for the remainder of 2022 are for debt service. Our other future cash requirements relate to working capital, capital expenditures, business development transactions (contingent consideration), restructuring, integration and separation costs, benefit obligations and litigation settlements. In addition, we may use cash to enter into licensing arrangements and/or to make strategic acquisitions. We regularly consider licensing and acquisition opportunities within our core therapeutic areas, some of which could be sizable.
In addition to our working capital requirements, as of
expect our primary cash requirements during the remainder of 2022 to include:
•Debt repayments-Based on our debt portfolio as ofNovember 3, 2022 , we anticipate making mandatory amortization payments of approximately$38 million and interest payments of approximately$284 million during the periodOctober 1, 2022 throughDecember 31, 2022 . As discussed below, we have and in the future may also elect to make additional principal payments under certain circumstances. Further, in the ordinary course of business, we may borrow and repay additional amounts under our credit facilities using cash on hand, cash from operations and cash provided from the sale of common stock and additional debt financings in connection with the B+L Separation; •IT Infrastructure Investment-We expect to make payments of approximately$11 million for licensing, maintenance and capitalizable costs associated with our IT infrastructure improvement projects during the periodOctober 1, 2022 throughDecember 31, 2022 ;
•Capital expenditures-We expect to make payments of approximately
for property, plant and equipment during the period
•Contingent consideration payments-We expect to make contingent consideration and other development/approval/sales-based milestone payments of approximately$12 million during the periodOctober 1, 2022 throughDecember 31, 2022 ; 92 -------------------------------------------------------------------------------- •Restructuring and integration payments-We expect to make payments of$3 million during the periodOctober 1, 2022 throughDecember 31, 2022 for employee separation costs and lease termination obligations associated with restructuring and integration actions we have taken throughSeptember 30, 2022 ; and
•Benefit obligations-We expect to make aggregate payments under our pension and
postretirement obligations of
through
Future Costs of B+L Separation
The Company has incurred costs associated with activities to complete the B+L Separation and the suspended Solta IPO and will continue to incur costs associated with the B+L Separation. These activities include the costs of: (i) separating Bausch + Lomb and theSolta Medical businesses from the remainder of the Company and (ii) registering Bausch + Lomb as an independent publicly traded entity. Separation and IPO costs are incremental costs directly related to the B+L Separation and Solta IPO and include, but are not limited to: (i) legal, audit and advisory fees, (ii) talent acquisition costs and (iii) costs associated with establishing new boards of directors and related board committees for Bausch + Lomb. The Company has also incurred, and will incur, separation-related and IPO-related costs which are incremental costs indirectly related to the B+L Separation. These costs include, but are not limited to: (i) IT infrastructure and software licensing costs, (ii) rebranding costs and (iii) costs associated with facility relocation and/or modification. The extent and timing of future charges for these costs cannot be reasonably estimated at this time and could be material. Litigation Payments In the ordinary course of business, the Company is involved in litigation, claims, government inquiries, investigations, charges and proceedings. During 2022, we made$1,572 million in payments of accrued legal settlements including payments related to the Securities Class Action Settlement, the Glumetza Antitrust Litigation and a RICO class action matter. As ofSeptember 30, 2022 , the Company's Consolidated Balance Sheet includes accrued loss contingencies of$323 million related to matters which are both probable and reasonably estimable, however, a reliable estimate of the period in which the remaining loss contingencies will be payable, if ever, cannot be made. Our ability to successfully defend the Company against pending and future litigation may impact future cash flows.
See Note 18, "LEGAL PROCEEDINGS" to our unaudited interim Consolidated Financial
Statements for further details.
Future Cost Savings Programs
We continue to evaluate opportunities to improve our operating results and may initiate additional cost savings programs to streamline our operations and eliminate redundant processes and expenses. These cost savings programs may include, but are not limited to: (i) reducing headcount, (ii) eliminating real estate costs associated with unused or under-utilized facilities and (iii) implementing contribution margin improvement and other cost reduction initiatives. The expenses associated with the implementation of these cost savings programs could be material and may impact our cash flows.
Future Licensing Payments
In the ordinary course of business, the Company may enter into select licensing and collaborative agreements for the commercialization and/or development of unique products primarily in theU.S. andCanada . In connection with these agreements, the Company may pay an upfront fee to secure the agreement. See Note 4, "LICENSING AGREEMENTS AND DIVESTITURE" to our unaudited interim Consolidated Financial Statements. Payments associated with the upfront fee for these agreements cannot be reasonably estimated at this time and could be material.
Unrecognized Tax Benefits
As of
remainder of 2022, however a reliable estimate of the period in which the
remaining uncertain tax positions will be payable, if ever, cannot be made.
Future Repurchases of Debt
The Company regularly evaluates market conditions, its liquidity profile, and various financing alternatives for opportunities to enhance its capital structure. If opportunities are favorable, we may, from time to time, purchase outstanding debt for cash in open market purchases or privately negotiated transactions. Such repurchases or exchanges, if any, will depend on prevailing market conditions, future liquidity requirements, contractual restrictions and other factors.
There have been no other material changes to the contractual obligations
disclosed in Item 7. "Management's Discussion and Analysis of Financial
Condition and Results of Operations - Off-Balance Sheet Arrangements and
Contractual Obligations" included in our Annual Report on Form 10-K for the year
ended
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OUTSTANDING SHARE DATA
Our common shares trade on the
Exchange
AtOctober 28, 2022 , we had 361,868,131 issued and outstanding common shares. In addition, as ofOctober 28, 2022 , we had outstanding 10,742,236 stock options and 9,032,437 time-based restricted share units that each represent the right of a holder to receive one of the Company's common shares, and 1,473,152 performance-based restricted share units that represent the right of a holder to receive a number of the Company's common shares up to a specified maximum. A maximum of 1,103,782 common shares could be issued upon vesting of the performance-based restricted share units outstanding.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Critical accounting policies and estimates are those policies and estimates that are most important and material to the preparation of our Consolidated Financial Statements, and which require management's most subjective and complex judgment due to the need to select policies from among alternatives available, and to make estimates about matters that are inherently uncertain. Management has reassessed the critical accounting policies and estimates as disclosed in Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Estimates" included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSEC and the CSA onFebruary 23, 2022 , and determined that there were no significant changes in our critical accounting policies and estimates during the nine months endedSeptember 30, 2022 , except for: (i) estimates and assumptions regarding the nature, timing and extent that the COVID-19 pandemic had on the Company's operations and cash flows as discussed in Note 2, "SIGNIFICANT ACCOUNTING POLICIES" to our unaudited interim Consolidated Financial Statements, (ii) the impact that the current year segment and reporting unit realignments had on the Company's allocation of goodwill, (iii) the assumptions utilized in the assessment of our Xifaxan® intangible assets and Salix goodwill for impairment, particularly those related to the range of possible outcomes of the Norwich Legal Decision and related developments, the potential timing of one or more generic versions of Xifaxan® being approved and introduced to the U.S. market, and the related estimated probability of each outcome, as discussed in Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim Consolidated Financial Statements and (iv) the estimates associated with the fair value ofOrtho Dermatologics reporting unit in testing goodwill for impairment as discussed in Note 8, "INTANGIBLE ASSETS AND GOODWILL" to our unaudited interim Consolidated Financial Statements. NEW ACCOUNTING STANDARDS None. FORWARD-LOOKING STATEMENTS Caution regarding forward-looking information and statements and "Safe-Harbor" statements under theU.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws: To the extent any statements made in this Form 10-Q contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information within the meaning defined under applicable Canadian securities laws (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things: our business strategy, business plans and prospects and forecasts and changes thereto; product pipeline, prospective products and product approvals, expected launches of new products, product development and future performance and results of current and anticipated products; anticipated revenues for our products; expected research and development ("R&D") and marketing spend; our expected primary cash and working capital requirements for this fiscal year and beyond; the Company's plans for continued improvement in operational efficiency and the anticipated impact of such plans; our liquidity and our ability to satisfy our debt maturities as they become due; our ability to reduce debt levels; our ability to comply with the financial and other covenants contained in the 2022 Amended Credit Agreement and senior notes indentures; the ability of our subsidiary, Bausch + Lomb, to comply with the financial and other covenants contained in the B+L Credit Agreement; the impact of our distribution, fulfillment and other third-party arrangements; proposed pricing actions; exposure to foreign currency exchange rate changes and interest rate changes; the outcome of contingencies, such as litigation, subpoenas, investigations, reviews, audits and regulatory proceedings; the anticipated impact of the adoption of new accounting standards; general market conditions; our expectations regarding our financial performance, including revenues, expenses, gross margins and income taxes; our impairment assessments, including the assumptions used therein and the results thereof; the anticipated impact of the evolving COVID-19 pandemic and related responses from governments and private sector participants on the Company, its supply chain, third-party suppliers, project development timelines, costs, revenues, margins, liquidity and financial condition, the anticipated 94
-------------------------------------------------------------------------------- timing, speed and magnitude of recovery from these COVID-19 pandemic related impacts and the Company's planned actions and responses to this pandemic; the anticipated impact from the ongoing conflict betweenRussia andUkraine ; and the Company's plan to separate its eye health business, including the structure and timing of completing such separation transaction. Forward-looking statements can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "estimate", "plan", "continue", "will", "may", "could", "would", "should", "target", "potential", "opportunity", "designed", "create", "predict", "project", "forecast", "seek", "strive", "ongoing", "decrease" or "increase" and variations or other similar expressions. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements may not be appropriate for other purposes. All of the statements in this Form 10-Q that contain forward-looking statements are qualified by these cautionary statements. These statements are based upon the current expectations and beliefs of management. Although we believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making such forward-looking statements, including, but not limited to, factors and assumptions regarding the items previously outlined, those factors, risks and uncertainties outlined below and the assumption that none of these factors, risks and uncertainties will cause actual results or events to differ materially from those described in such forward-looking statements. Actual results may differ materially from those expressed or implied in such statements. Important factors, risks and uncertainties that could cause actual results to differ materially from these expectations include, among other things, the following: •the risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, the fear of that pandemic, the availability and effectiveness of vaccines for COVID-19 (including with respect to current or future variants and subvariants), COVID-19 vaccine immunization rates, the emergence of variant and subvariant strains of COVID-19, the resurgence of the COVID-19 virus and variant and subvariant strains thereof (including, but not limited to, the recent resurgence of COVID-19 cases) and any resulting reinstitution of lockdowns and other restrictions, the evolving reaction of governments, private sector participants and the public to that pandemic, and the potential effects and economic impact of the pandemic and the reaction to it, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a significant adverse impact on the Company, including, but not limited to, its supply chain, third-party suppliers, project development timelines, employee base, liquidity, stock price, financial condition, costs (which may increase) and revenue and margins (both of which may decrease); •the challenges the Company faces as a result of the closing of the B+L IPO, including the transitional services being provided by and to Bausch + Lomb, any potential, actual or perceived conflict of interest of some of our directors and officers because of their equity ownership in Bausch + Lomb and/or because they also serve as directors or officers of Bausch + Lomb and our ability to timely consolidate the financial results of the Bausch + Lomb business; •with respect to the Company's proposed B+L Separation, the risks and uncertainties include, but are not limited to, the expected benefits and costs of the B+L Separation, the expected timing of completion of the B+L Separation and its terms, the Company's ability to complete the B+L Separation considering the various conditions to the completion of the B+L Separation (some of which are outside the Company's control, including conditions related to regulatory matters and applicable shareholder and stock exchange approvals), that market or other conditions are no longer favorable to completing the B+L Separation, that the previously announced planned Solta IPO has been suspended, that the Norwich Legal Decision (see "Xifaxan® Paragraph IV Proceedings" of Note 18, "LEGAL PROCEEDINGS" to our unaudited interim Consolidated Financial Statements) may affect the timing of, or our ability to complete the B+L Separation, that applicable shareholder, stock exchange, regulatory or other approvals are not obtained on the terms or timelines anticipated or at all, business disruption during the pendency of, or following, the B+L Separation, diversion of management time on separation transaction-related issues, retention of existing management team members, the reaction of customers and other parties to the separation transaction, the qualification of the separation transaction as a tax-free transaction for Canadian and/orU.S. federal income tax purposes (including whether or not an advance ruling from theCanada Revenue Agency and/or the Internal Revenue Service will be sought or obtained), the ability of the Company and the separated entity to satisfy the conditions required to maintain the tax-free status of the B+L Separation (some of which are beyond their control), limitations on the Company's ability to sell a portion of the Company's interest in Bausch + Lomb in order to maintain the tax-free status of the B+L Separation (including due to dilution from B+L's issuance of share-based compensation awards), other potential tax or other liabilities that may arise as a result of the B+L Separation, the potential dissynergy costs resulting from the B+L Separation, the impact of the B+L Separation on relationships with customers, suppliers, employees and other business counterparties, general economic conditions, conditions in the markets the Company is engaged in, behavior of customers, suppliers and competitors, technological developments, as well as legal and regulatory rules affecting the Company's business. In particular, the Company can offer no 95 --------------------------------------------------------------------------------
assurance that any B+L Separation will occur at all, or that any such
transaction will occur on the timelines anticipated by the Company;
•ongoing litigation and potential additional litigation, claims, challenges and/or regulatory investigations challenging or otherwise relating to the B+L IPO and the B+L Separation and the costs, expenses, use of resources, diversion of management time and efforts, liability and damages that may result therefrom; •the expense, timing and outcome of legal and governmental proceedings, investigations and information requests relating to, among other matters, our past distribution, marketing, pricing, disclosure and accounting practices (including with respect to our former relationship withPhilidor Rx Services, LLC ("Philidor")), including a number of pending non-class securities litigations (including certain pending opt-out actions in theU.S. related to the previously settled securities class action and certain opt-out actions inCanada relating to the previously settled class action inCanada ), certain pending lawsuits and other claims, investigations or proceedings that may be initiated or that may be asserted; •potential additional litigation and regulatory investigations (and any costs, expenses, use of resources, diversion of management time and efforts, liability and damages that may result therefrom), negative publicity and reputational harm on our Company, products and business that may result from the past and ongoing public scrutiny of our past distribution, marketing, pricing, disclosure and accounting practices and from our former relationship with Philidor; •the past and ongoing scrutiny of our legacy business practices, including with respect to pricing, and any pricing controls or price adjustments that may be sought or imposed on our products as a result thereof; •pricing decisions that we have implemented, or may in the future elect to implement, such as the Patient Access and Pricing Committee's historic practice of limiting the average annual price increase for our branded prescription pharmaceutical products to single digits, or any future pricing actions we may take this fiscal year or beyond following review by our Patient Access and Pricing Committee (which is responsible for the pricing of our drugs); •legislative or policy efforts, including those that may be introduced and passed by theU.S. Congress , designed to reduce patient out-of-pocket costs for medicines, which could result in new mandatory rebates and discounts or other pricing restrictions, controls or regulations (including mandatory price reductions); •ongoing oversight and review of our products and facilities by regulatory and governmental agencies, including periodic audits by theU.S. Food and Drug Administration (the "FDA") and equivalent agencies outside of theU.S. and the results thereof;
•actions by the FDA or other regulatory authorities with respect to our products
or facilities;
•compliance with the legal and regulatory requirements of our marketed products;
•our substantial debt (and potential additional future indebtedness) and current
and future debt service obligations, our ability to reduce our outstanding debt
levels and the resulting impact on our financial condition, cash flows and
results of operations;
•our ability to comply with the financial and other covenants contained in our
senior notes indentures, the 2027 Revolving Credit Facility, the 2022 Amended
Credit Agreement, the B+L Credit Agreement and other current or future credit
and/or debt agreements, including the ability of Bausch + Lomb to comply with
its covenants and obligations under the B+L Credit Agreement, restrictions and
prohibitions such covenants impose or may impose on the way we conduct our
business, including prohibitions on incurring additional debt if certain
financial covenants are not met, limitations on the amount of additional
obligations we are able to incur pursuant to other covenants, our ability to
draw under our 2027 Revolving Credit Facility, Bausch + Lomb's ability to draw
down under the revolving credit facility under the B+L Credit Agreement and
restrictions on our ability to make certain investments and other restricted
payments;
•any default under the terms of our senior notes indentures or the 2022 Amended
Credit Agreement (and other current or future credit and/or debt agreements) and
our ability, if any, to cure or obtain waivers of such default;
•any downgrade by rating agencies in our credit ratings, which may impact, among
other things, our ability to raise debt and the cost of capital for additional
debt issuances;
96
-------------------------------------------------------------------------------- •any reductions in, or changes in the assumptions used in, our forecasts for this fiscal year or beyond, including as a result of the impacts of the COVID-19 pandemic on our business and operations, which could lead to, among other things: (i) a failure to meet the financial and/or other covenants contained in the 2022 Amended Credit Agreement, senior notes indentures and/or the B+L Credit Agreement (and other current or future credit and/or debt agreements) and/or (ii) impairment in the goodwill associated with certain of our reporting units or impairment charges related to certain of our products or other intangible assets, which impairments could be material; •changes in the assumptions used in connection with our impairment analyses or assessments, which would lead to a change in such impairment analyses and assessments and which could result in an impairment in the goodwill associated with any of our reporting units or impairment charges related to certain of our products or other intangible assets; •the uncertainties associated with the acquisition and launch of new products, assets and businesses, including, but not limited to, our ability to provide the time, resources, expertise and funds required for the commercial launch of new products, the acceptance and demand for new products, and the impact of competitive products and pricing, which could lead to material impairment charges;
•our ability or inability to extend the profitable life of our products,
including through line extensions and other life-cycle programs;
•our ability to retain, motivate and recruit directors, executives and other
key employees;
•our ability to implement effective succession planning for our executives and
key employees;
•factors impacting our ability to stabilize and reposition ourOrtho Dermatologics business to generate additional value, including the success of recently launched products and the approval of pipeline products (and the timing of such approvals); •factors impacting our ability to achieve anticipated revenues for our products, including changes in anticipated marketing spend on such products and launch of competing products;
•factors impacting our ability to achieve anticipated market acceptance for our
products, including acceptance of the pricing, effectiveness of promotional
efforts, reputation of our products and launch of competing products;
•the challenges and difficulties associated with managing a large complex
business, which has, in the past, grown rapidly;
•our ability to compete against companies that are larger and have greater
financial, technical and human resources than we do, as well as other
competitive factors, such as technological advances achieved, patents obtained
and new products introduced by our competitors;
•our ability to effectively operate and grow our businesses in light of the
challenges that the Company has faced and market conditions, including with
respect to its substantial debt, pending investigations and legal proceedings,
scrutiny of our past pricing and other practices, limitations on the way we
conduct business imposed by the covenants contained in our 2022 Amended Credit
Agreement, the B+L Credit Agreement, our senior notes indentures and the
agreements governing our other indebtedness, and the impacts of the COVID-19
pandemic;
•the extent to which our products are reimbursed by government authorities,
pharmacy benefit managers ("PBMs") and other third-party payors; the impact our
distribution, pricing and other practices may have on the decisions of such
government authorities, PBMs and other third-party payors to reimburse our
products; the impact of obtaining or maintaining such reimbursement on the price
and sales of our products; and the launch and implementation of any new
pharma-care or dental-care program or related spending by the Canadian federal
government;
•the inclusion of our products on formularies or our ability to achieve
favorable formulary status, as well as the impact on the price and sales of our
products in connection therewith;
•the consolidation of wholesalers, retail drug chains and other customer groups
and the impact of such industry consolidation on our business;
•our ability to maintain strong relationships with physicians and other
healthcare professionals;
•our eligibility for benefits under tax treaties and the availability of low
effective tax rates for the business profits of certain of our subsidiaries;
97 --------------------------------------------------------------------------------
•the implementation of the Organisation for Economic Co-operation and
Development Inclusive Framework on Base Erosion and Profit Shifting, including
the global minimum corporate tax rate, by the countries in which we operate;
•the outcome of any audits by taxation authorities, which outcomes may differ
from the estimates and assumptions that we may use in determining our
consolidated tax provisions and accruals;
•the actions of our third-party partners or service providers of research, development, manufacturing, marketing, distribution or other services, including their compliance with applicable laws and contracts, which actions may be beyond our control or influence, and the impact of such actions on our Company; •the risks associated with the international scope of our operations, including our presence in emerging markets and the challenges we face when entering and operating in new and different geographic markets (including the challenges created by new and different regulatory regimes in such countries and the need to comply with applicable anti-bribery and economic sanctions laws and regulations); •adverse global economic conditions, including rates of inflation, and credit markets and foreign currency exchange uncertainty and volatility in certain of the countries in which we do business;
•the trade conflict between the
•the impact of the ongoing conflict betweenRussia andUkraine and the export controls, sanctions and other restrictive actions that have been or may be imposed by theU.S. ,Canada and other countries against governmental and other entities inRussia ,Belarus and parts ofUkraine ;
•the impact of
potential changes to other trade agreements;
•our ability to obtain, maintain and license sufficient intellectual property rights over our products and enforce and defend against challenges to such intellectual property (such as in connection with the filing byNorwich Pharmaceuticals Inc. ("Norwich") of its Abbreviated New Drug Application ("ANDA") for Xifaxan® (rifaximin) 550 mg tablets and the Company's related lawsuit filed against Norwich in connection therewith) and the impact of the Norwich Legal Decision on, among other things, our business results, financial results, and the B+L Separation; •our ability to successfully appeal the decision of theU.S. District Court for the District ofDelaware in the Company's lawsuit against Norwich in connection with Norwich's ANDA and challenge Norwich's ability to achieve a modified ANDA that avoids the August 10, 2022 final judgement by the District Court and omits the Xifaxan® hepatic encephalopathy ("HE") indication and HE safety data; •the fact that a substantial amount of our revenues are derived from the Xifaxan® product line, and that we may be materially impacted by the entry of a generic rifaximin product earlier than January 2028, including the risk of a competitor launching a generic rifaximin at risk prior to a final unappealable decision; •the introduction of generic, biosimilar or other competitors of our branded products and other products, including the introduction of products that compete against our products that do not have patent or data exclusivity rights; •our ability to identify, finance, acquire, close and integrate acquisition targets successfully and on a timely basis and the difficulties, challenges, time and resources associated with the integration of acquired companies, businesses and products; •any divestitures of our assets or businesses and our ability to successfully complete any such divestitures on commercially reasonable terms and on a timely basis, or at all, and the impact of any such divestitures on our Company, including the reduction in the size or scope of our business or market share, loss of revenue, any loss on sale, including any resultant impairments of goodwill or other assets, or any adverse tax consequences suffered as a result of any such divestitures; •the expense, timing and outcome of pending or future legal and governmental proceedings, arbitrations, investigations, subpoenas, tax and other regulatory audits, examinations, reviews and regulatory proceedings against us or relating to us and settlements thereof;
•our ability to negotiate the terms of or obtain court approval for the
settlement of certain legal and regulatory proceedings;
•our ability to obtain components, raw materials or finished products supplied
by third parties (some of which may be single-sourced) and other manufacturing
and related supply difficulties, interruptions and delays;
98
--------------------------------------------------------------------------------
•the disruption of delivery of our products and the routine flow of manufactured
goods;
•economic factors over which the Company has no control, including changes in inflation, interest rates, foreign currency rates, and the potential effect of such factors on revenues, expenses and resulting margins;
•interest rate risks associated with our floating rate debt borrowings;
•our ability to effectively distribute our products and the effectiveness and
success of our distribution arrangements;
•our ability to effectively promote our own products and those of our
co-promotion partners;
•the success of our fulfillment arrangements withWalgreen Co. , including market acceptance of, or market reaction to, such arrangements (including by customers, doctors, patients, PBMs, third-party payors and governmental agencies), and the continued compliance of such arrangements with applicable laws;
•our ability to secure and maintain third-party research, development,
manufacturing, licensing, marketing or distribution arrangements;
•the risk that our products could cause, or be alleged to cause, personal injury and adverse effects, leading to potential lawsuits, product liability claims and damages and/or recalls or withdrawals of products from the market;
•the mandatory or voluntary recall or withdrawal of our products from the market
and the costs associated therewith;
•the availability of, and our ability to obtain and maintain, adequate insurance coverage and/or our ability to cover or insure against the total amount of the claims and liabilities we face, whether through third-party insurance or self-insurance;
•our indemnity agreements, which may result in an obligation to indemnify or
reimburse the relevant counterparty, which amounts may be material;
•the difficulty in predicting the expense, timing and outcome within our legal
and regulatory environment, including with respect to approvals by the FDA,
countries, legal and regulatory proceedings and settlements thereof, the
protection afforded by our patents and other intellectual and proprietary
property, successful generic challenges to our products and infringement or
alleged infringement of the intellectual property of others;
•the results of continuing safety and efficacy studies by industry and
government agencies;
•the success of preclinical and clinical trials for our drug development pipeline or delays in clinical trials that adversely impact the timely commercialization of our pipeline products, as well as other factors impacting the commercial success of our products, which could lead to material impairment charges;
•uncertainties around the successful improvement and modification of our
existing products and development of new products, which may require significant
expenditures and efforts;
•the results of management reviews of our research and development portfolio (including following the receipt of clinical results or feedback from the FDA or other regulatory authorities), which could result in terminations of specific projects which, in turn, could lead to material impairment charges;
•the seasonality of sales of certain of our products;
•declines in the pricing and sales volume of certain of our products that are
distributed or marketed by third parties, over which we have no or limited
control;
•compliance by the Company or our third-party partners and service providers (over whom we may have limited influence), or the failure of our Company or these third parties to comply, with health care "fraud and abuse" laws and other extensive regulation of our marketing, promotional and business practices (including with respect to pricing), worldwide anti-bribery laws (including theU.S. Foreign Corrupt Practices Act and the Canadian Corruption of Foreign Public Officials Act), worldwide economic sanctions and/or export laws, worldwide environmental laws and regulation and privacy and security regulations; •the impacts of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 and potential amendment thereof and other legislative and regulatory health care reforms in the countries in which we operate, including with respect to recent government inquiries on pricing; 99 --------------------------------------------------------------------------------
•the impact of any changes in or reforms to the legislation, laws, rules,
regulation and guidance that apply to the Company and its businesses and
products or the enactment of any new or proposed legislation, laws, rules,
regulations or guidance that will impact or apply to the Company or its
businesses or products;
•the impact of changes in federal laws and policy that may be undertaken under
the current administration;
•illegal distribution or sale of counterfeit versions of our products;
•any plans for the Company's aesthetic medical business;
•interruptions, breakdowns or breaches in our information technology systems;
and
•risks in Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on February 23, 2022, risks under Item 1A. "Risk Factors" of Part II of this Form 10-Q and risks detailed from time to time in our other filings with theU.S. Securities and Exchange Commission ("SEC") and the Canadian Securities Administrators (the "CSA"), as well as our ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on February 23, 2022, under Item 1A. "Risk Factors", under Item 1A. "Risk Factors" of Part II of this Form 10-Q and in the Company's other filings with theSEC and the CSA. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. These forward-looking statements speak only as of the date made. We undertake no obligation to update or revise any of these forward-looking statements to reflect events or circumstances after the date of this Form 10-Q or to reflect actual outcomes, except as required by law. We caution that, as it is not possible to predict or identify all relevant factors that may impact forward-looking statements, the foregoing list of important factors that may affect future results is not exhaustive and should not be considered a complete statement of all potential risks and uncertainties.
ENACT HOLDINGS, INC. – 10-Q – MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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