TREACE MEDICAL CONCEPTS, INC. – 10-Q – Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed financial statements and related notes thereto included in this Quarterly Report on Form 10-Q (the "Quarterly Report") and our audited financial statements and related notes thereto for the year endedDecember 31, 2022 , included in our Annual Report on Form 10-K filed with theU.S. Securities and Exchange Commission onMarch 8, 2023 (our "Annual Report"). This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in our Annual Report under "Part I, Item 1A-Risk Factors" and in the section titled "Risk Factors" included elsewhere in this Quarterly Report on Form 10-Q. Please also see the section of this Quarterly Report titled "Special Note Regarding Forward-Looking Statements."
Overview
We are a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. We have pioneered our proprietary Lapiplasty® 3D Bunion Correction System-a combination of instruments, implants and surgical methods designed to surgically correct all three planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. Although bunions are deformities typically caused by an unstable joint in the middle of the foot that leads to a three-dimensional ("3D") misalignment in the foot's anatomical structure, the majority of traditional surgical approaches focus on correcting the deformity from a two-dimensional ("2D") perspective and therefore fail to address the root cause of the disorder. To effectively restore the normal anatomy of bunion patients and improve clinical outcomes, we believe addressing the root cause of the bunion is critical and have developed the Lapiplasty System to correct the deformity across all three anatomic dimensions. Our mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty System as the standard of care. In 2021, we expanded our offerings with the Adductoplasty® Midfoot Correction System, designed for reproducible correction of the midfoot to provide further support to hallux valgus patients. We were formed in 2013 and since receiving 510(k) clearance for the Lapiplasty System inMarch 2015 , we have sold more than 70,000 Lapiplasty Procedure Kits inthe United States . We market and sell our Lapiplasty Systems to physicians, surgeons, ambulatory surgery centers and hospitals. The Lapiplasty Procedure can be performed in either hospital outpatient or ambulatory surgery centers settings, and utilizes existing, well-established reimbursement codes. We currently market and sell the Lapiplasty System through a combination of a direct employee sales force and independent sales agencies across 191 territories inthe United States . As ofMarch 31, 2023 , we had 167 direct sales representatives and 24 independent sales agencies. In the three months endedMarch 31, 2023 , employee sales representatives generated approximately 79% of revenues while approximately 21% of revenues came through independent sales agencies. OnFebruary 10, 2023 , we completed a follow-on public offering of 5,476,190 shares of our common stock, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of$21.00 per share. This offering resulted in net proceeds of$107.5 million after deducting underwriting discounts and commissions of$6.9 million and offering expenses of$0.6 million , adding additional funds to our liquidity. As ofMarch 31, 2023 , we had cash and cash equivalents of$29.6 million and marketable securities available-for-sale of$141.0 million to fund operations, an accumulated deficit of$98.2 million , and$54.0 million of principal outstanding under our term loan and revolving loan agreements.
COVID-19 Impact
The COVID-19 pandemic has had intermittent impacts on our business, operations and financial results and condition. The COVID-19 pandemic and the related reduction in elective procedures and limited hospital staffing and capacity due to the governmental "shelter-in-place" requirement slowed our revenue growth in 2020 and 2021. While it is difficult to determine with certainty, we believe that the COVID-19 pandemic did not have a significant impact on our 2022 or first quarter 2023 operations and financial results. There is still uncertainty around the potential impacts related to COVID-19, especially if governments and hospitals respond as they did in 2020 and 2021 if potentially more contagious and virulent variants of the virus emerge. We cannot assure you that we will not experience additional negative impacts associated with COVID-19 in the future, which could be significant. 16 --------------------------------------------------------------------------------
Economic Environment
There is uncertainty in the macro-economic environment. Inflationary pressures, rising interest rates, reduced consumer confidence and ongoing supply chain challenges may result in higher costs and longer lead times from suppliers and potentially reduced demand for our Lapiplasty Procedure Kits. General economic conditions may also negatively impact demand for elective surgeries. While we continuously work with suppliers to mitigate higher costs and longer lead times and continue to invest in our direct sales channel, patient education initiatives, clinical evidence and product innovations to build demand for our products, we expect these macro-economic challenges to continue throughout 2023, which may impact our results of operations. Key Business Metrics We regularly review a number of operating and financial metrics, including the number of Lapiplasty Procedure Kits sold, blended average revenue per Lapiplasty Procedure Kits sold, the number of active surgeons using the Lapiplasty System and the surgeon utilization rate, to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plans and make strategic decisions. The number of Lapiplasty Procedure Kits sold during the three months endedMarch 31, 2023 increased by 1,480 or 28% over the same period of 2022. The blended average sales price per Lapiplasty Procedure Kits sold was$6,244 during the three months endedMarch 31, 2023 , a 13% increase over the same period of 2022. We define the blended average sales price as revenue divided by Lapiplasty Procedure Kits sold that includes the revenue for ancillary products sold from our expanding product line. The number of active surgeons as ofMarch 31, 2023 was 2,499, an increase of 31.5% from the prior year. We define the number of active surgeons as the number of surgeons that performed at least one procedure using the Lapiplasty System in the trailing twelve-month period. The surgeon utilization rate for the three months endedMarch 31, 2023 increased by 3.2% over the same period of 2022, to an average of 10.5 Lapiplasty Procedure Kits per active surgeon. We believe that the number of Lapiplasty Procedure Kits sold, blended average revenue per Lapiplasty Procedure Kits sold, number of active surgeons using the Lapiplasty System and the surgeon utilization rate are useful indicators of our ability to drive adoption of the Lapiplasty System and generate revenue and are helpful in tracking the progress of our business. While we believe these metrics are representative of our current business, we anticipate these metrics may be substituted for additional or different metrics as our business grows.
Factors Affecting Our Business
We believe that our financial performance has been and in the foreseeable future, will continue to depend on many factors, including COVID-19 and other macro-economic conditions as described above, those described below, those referenced in the section titled "Special Note Regarding Forward-Looking Statements" and those set forth in our Annual Report in the section titled "Part I, Item 1A-Risk Factors" and in the section titled "Risk Factors" included elsewhere in this Quarterly Report.
Adoption of the Lapiplasty System
The growth of our business depends on our ability to gain broader acceptance of the Lapiplasty System by successfully marketing and distributing the Lapiplasty System and ancillary products. We currently have approval at over 2,000 facilities acrossthe United States and plan to continue to increase access by convincing more surgeons and facility administrators that our products are alternatives to traditional products used in bunion surgical procedures. While surgeon adoption of the Lapiplasty Procedure remains critical to driving procedure growth, hospital and ambulatory surgery center facility approvals are necessary for both existing and future surgeon customers to access our products. To facilitate greater access to our products and drive future sales growth, we intend to continue educating hospitals and facility administrators on the differentiated benefits associated with the Lapiplasty System, supported by our robust portfolio of clinical data. If we are unable to successfully continue to commercialize our Lapiplasty System, we may not be able to generate sufficient revenue to achieve or sustain profitability. In the near term, we expect we will continue to operate at a loss, and we anticipate we will finance our operations principally through offerings of our capital stock and by incurring debt. 17 --------------------------------------------------------------------------------
Investments in Innovation and Growth
We expect to continue to focus on long-term revenue growth through investments in our business. In sales and marketing, we are dedicating meaningful resources to expand our sales force and management team inthe United States , as well as our patient focused outreach and education campaigns. We are hiring additional employee sales representatives and employee field sales management to strategically access more regions with high densities of prospective patients and by focusing the efforts of our independent sales channel on our products. In research and development, our team and ourSurgeon Advisory Board are continually working on next-generation innovations of the Lapiplasty System and related products. In addition to expanding our Lapiplasty offerings with products like the Lapiplasty Mini-Incision and Micro-Lapiplasty Minimally Invasive Systems, we are continually exploring opportunities to advance our core Lapiplasty System instrumentation and implants to further improve surgical efficiency, enhance reproducibility of outcomes and speed surgical recovery for patients. In 2022, we introduced (i) the 3-n-1™ Guide, which combines three separate instruments and three procedure steps into one instrument and step, (ii) the S4A™ plating system, which features advanced 3D contours designed to accommodate variations in patient anatomy, and (iii) the SpeedRelease™ Instrument, which is a single-use instrument designed to make a challenging soft tissue release performed in the majority of Lapiplasty cases easier to perform and more reproducible for the surgeon. We are also pursuing the development and potential commercialization, if cleared, of new products to address ancillary surgical procedures performed routinely in connection with the Lapiplasty Procedure. For example, to help address midfoot deformities that can occur in up to 30% of bunion patients, we developed and, inSeptember 2021 , announced the commercial launch of the Adductoplasty System. The Adductoplasty System brings together our implants and instrumentation to provide a comprehensive system designed for reproducible realignment, stabilization, and fusion of the midfoot and thus, provides surgeons with a precision, instrumented approach to treat both the bunion and coexisting midfoot deformities. Moreover, in our general and administrative functions, we expect to continue to hire personnel and expand our infrastructure to both drive and support our anticipated growth and operations as a public company. Accordingly, in the near term, we expect these activities to increase our net losses, but in the longer term we anticipate they will positively impact our business and results of operations.
Seasonality
We have experienced and expect to continue to experience seasonality in our business, with higher sales volumes in the fourth calendar quarter, historically accounting for approximately 35% to 40% of full year revenues, and lower sales volumes in subsequent first calendar quarter. Our sales volumes in the fourth quarter tend to be higher as many patients elect to have surgery after meeting their annual deductible and having time to recover over the winter holidays. Our sales volumes in subsequent first calendar quarters also tend to be lower as a result of adverse weather and by resetting annual patient healthcare insurance plan deductibles, both of which may cause patients to delay elective procedures. The orthopaedic industry traditionally experiences lower sales volumes in the third quarter than throughout the rest of the year as elective procedures generally decline during the summer months. Although we follow orthopaedic industry trends generally, to date our third quarter sales volumes have not been lower than other quarters, but we may experience relatively lower sales volumes during third quarters in the future.
Coverage and Reimbursement
Hospitals, ambulatory surgery centers and surgeons that purchase or use our products generally rely on third-party payors to reimburse for all or part of the costs and fees associated with procedures using our products. As a result, sales of our products depend, in part, on the extent to which the procedures using our products are covered by third-party payors, including government programs such as Medicare and Medicaid, private insurance plans and managed care programs. Based on historical claims data from 2017, approximately 63% of Lapidus cases and 60% of all bunion surgical cases were paid by private payors. Medicare payment rates to hospital outpatient departments are set under the Medicare hospital outpatient prospective payment system, which groups clinically similar hospital outpatient procedures and services with similar costs to ambulatory payment classifications ("APCs"). Each APC is assigned a single lump sum payment rate, which includes payment for the primary procedure as well as any integral, ancillary, and adjunctive services. The primary CPT codes for the Lapiplasty Procedure, CPT 28297 and CPT 28740, are grouped together under APC 5114. For Lapiplasty Procedures in which fusion is performed on multiple tarsometatarsal joints, CPT 28730 applies and is classified under APC 5115. 18 --------------------------------------------------------------------------------
Components of Our Results of Operations
Revenue
We currently derive significant amounts of our revenue from the sale of our proprietary Lapiplasty System, and to a lesser extent from the Adductoplasty System, which we introduced in the third quarter of 2021, as well as our ancillary products. The Lapiplasty and Adductoplasty Systems are comprised of single-use implant kits and reusable instrument trays. We sell the Lapiplasty and Adductoplasty Systems to physicians, surgeons, hospitals, and ambulatory surgery centers inthe United States through a network of employee sales representatives and independent sales agencies. Our primary product is the Lapiplasty System, which is an instrumented, reproducible approach to 3D bunion correction that helps patients rapidly return to weight-bearing in a post-operative boot. We also offer other advanced instrumentation and implants for use in the Lapiplasty and Adductoplasty Procedures or other ancillary procedures performed in high frequency with bunion surgery. No single customer accounted for 10% or more of our revenue during the three months endedMarch 31, 2023 . We expect our revenue to increase in absolute dollars in the foreseeable future as we expand our sales territories, new accounts and trained physician base and as existing physician customers perform more Lapiplasty Procedures, though it may fluctuate from quarter to quarter due to a variety of factors, including seasonality and the macro-economic environment.
Cost of Goods Sold
Cost of goods sold consists primarily of manufacturing costs for the purchase of our Lapiplasty and Adductoplasty Systems and other products from third-party manufacturers. Direct costs from our third-party manufacturers include costs for materials plus the markup for the assembly of the components. Cost of goods sold also includes royalties, allocated overhead for indirect labor, certain direct costs such as those incurred for shipping our products and personnel costs. We expense all provisions for excess and obsolete inventories as cost of goods sold. We record adjustments to our inventory valuation for estimated excess, obsolete and non-sellable inventories based on assumptions about future demand, past usage, changes to manufacturing processes and overall market conditions. We expect our cost of goods sold to increase in absolute dollars in the foreseeable future to the extent more of our products are sold, though it may fluctuate from quarter to quarter. Gross Profit and Gross Margin We calculate gross profit as revenue less cost of goods sold, and gross margin as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily average selling prices, production, and ordering volumes, change in mix of customers, third-party manufacturing costs and cost-reduction strategies. We expect our gross profit to increase in the foreseeable future as our revenue grows, though our gross margin may fluctuate from quarter to quarter due to changes in average selling prices as we introduce new products, and as we adopt new manufacturing processes and technologies. Operating Expenses Sales and Marketing Sales and marketing expenses consist primarily of compensation for personnel, including salaries, bonuses, benefits, sales commissions and share-based compensation, related to selling and marketing functions, surgical instrument expense, physician education programs, training, shipping costs related to sending products to our sales representatives, travel expenses, marketing initiatives including our direct-to-patient outreach program and advertising, market research and analysis and conferences and trade shows. We expect sales and marketing expenses to continue to increase in absolute dollars in the foreseeable future as we continue to invest in our direct sales force and expand our marketing efforts, and as we continue to expand our sales and marketing infrastructure to both drive and support anticipated sales growth, though it may fluctuate from quarter to quarter. 19 --------------------------------------------------------------------------------
Research and Development
Research and development ("R&D") expenses consist primarily of engineering, product development, clinical studies to develop and support our products, regulatory expenses, and other costs associated with products and technologies that are in development. These expenses include compensation for personnel, including salaries, bonuses, benefits and share-based compensation, supplies, consulting, prototyping, testing, materials, travel expenses, depreciation, and an allocation of facility overhead expenses. We expect R&D expenses to continue to increase in absolute dollars in the foreseeable future as we continue to hire personnel and invest in next-generation innovations of the Lapiplasty System and related products, though it may fluctuate from quarter to quarter due to a variety of factors, including the level and timing of our new product development efforts, as well as our clinical development, clinical trial and other related activities. General and Administrative General and administrative expenses consist primarily of compensation for personnel, including salaries, bonuses, benefits, and share-based compensation, related to finance, information technology ("IT"), legal and human resource functions, as well as professional services fees (including legal, audit and tax fees), insurance costs, general corporate expenses, rent expenses and allocated facilities-related expenses. We expect general and administrative expenses to continue to increase in absolute dollars in the foreseeable future as we hire personnel and expand our infrastructure to drive and support the anticipated growth in our organization. Moreover, we have incurred, and expect to continue to incur, additional general and administrative expenses associated with operating as a public company, including legal, accounting, insurance, compliance with the rules and regulations of theSEC and those of any stock exchange on which our securities are traded, investor relations and other administrative and professional services expenses.
Interest income
Interest income consists of interest received on our money market funds and
marketable securities.
Interest Expense
Interest expense consists of interest incurred and amortization of debt discount
and issuance costs related to outstanding borrowings during the reported
periods.
Results of Operations
Comparison of the three months ended
The following table summarizes our results of operations for the periods
presented below ($ in thousands):
Three Months Ended March 31, Change 2023 2022 Amount % Revenue$ 42,195 $ 29,047 $ 13,148 45.3% Cost of goods sold 8,039 5,130 2,909 56.7% Gross profit 34,156 23,917 10,239 42.8% Operating expenses Sales and marketing 33,655 22,299 11,356 50.9% Research and development 3,412 3,052 360 11.8% General and administrative 10,865 6,662 4,203 63.1% Total operating expenses 47,932 32,013 15,919 49.7% Loss from operations (13,776 ) (8,096 ) (5,680 ) 70.2% Interest income 1,479 9 1,470 * Interest expense (1,285 ) (951 ) (334 ) 35.1% Other income, net 128 2 126 * Other non-operating income (expense), net 322 (940 ) 1,262 (134.3)% Net loss$ (13,454 ) $ (9,036 ) $ (4,418 ) 48.9% 20
--------------------------------------------------------------------------------
Comparison of the three months ended
Revenue. Revenue increased by$13.1 million , or 45.3%, for the three months endedMarch 31, 2023 as compared to the same period in 2022. The increase in the number of Lapiplasty Procedure Kits sold was 28% and 51% for the three months endedMarch 31, 2023 and 2022, respectively. The increase in the volume of Lapiplasty Procedure Kits sold resulted in 52% and 79% of the revenue growth from the three months endedMarch 31, 2023 and 2022, respectively, as compared to the same period in 2022 and 2021, respectively. In the three months endedMarch 31, 2023 , the remaining revenue growth was primarily a result of increased adoption of our newer technologies and selling more ancillary products used in bunion cases resulting in a 13% increase in average blended revenue per case compared to the prior year. Cost of Goods Sold, Gross Profit and Gross Margin. Cost of goods sold increased by$2.9 million , or 56.7%, for the three months endedMarch 31, 2023 as compared to the same period in 2022. The increase in cost of goods sold was primarily due to a$1.7 million increase in direct costs of goods sold and a$0.2 million increase in royalty expense resulting from increased sales, a$0.7 million increase in overhead expenses resulting from increased headcount and a$0.2 million increase in reserves for inventory provision and obsolescence. During the three months endedMarch 31, 2023 , gross profit increased by$10.2 million , or 42.8%, as compared to the same period in 2022, due to increased sales. Gross profit margin for the three months endedMarch 31, 2023 decreased from 82.3% to 80.9%, as compared to the same period of 2022, primarily due to an increase in payroll costs and an increase in inventory and obsolescence provisions, partially offset by lower royalty rates on newer products. Sales and Marketing Expenses. Sales and marketing expenses increased by$11.4 million , or 50.9%, for the three months endedMarch 31, 2023 as compared to the same period in 2022. Sales and marketing expenses increased as a result of an increase of$4.8 million in payroll and related expenses from increased headcount of sales personnel, an increase of$3.8 million primarily for higher commissions from increased sales by our employee sales representatives and independent sales agencies, an increase of$2.0 million in advertising and marketing-related expenses primarily due to higher advertising spending for direct to consumer campaigns and sales meeting costs, an increase of$0.4 million in surgical instrument expense of surgical instruments and an increase of$0.6 million in health care professional training and clinical-related expenses. Research and Development Expenses. R&D expenses increased by$0.4 million , or 11.8%, for the three months endedMarch 31, 2023 as compared to the same period in 2022. The increase in R&D expenses was primarily due to an increase of$0.1 million in clinical expenses resulting primarily from increased purchases of materials used in our prototypes and a$0.1 million increase in general business expenses. General and Administrative Expenses. General and administrative expenses increased by$4.2 million , or 63.1%, for the three months endedMarch 31, 2023 as compared to the same period in 2022. The increase in general and administrative expenses was primarily due to an increase of$2.3 million in payroll and related costs as we increased headcount to support our growing business, an increase of$0.7 million in rent expense and occupancy costs related to moving into our new headquarters in the third quarter of 2022 and an increase of$1.6 million in professional services primarily related to an increase of$1.8 million in legal expenses, slightly offset by a decrease in other professional services. Interest income. Interest income increased by$1.5 million , for the three months endedMarch 31, 2023 as compared to the same period of 2022. The increase in interest income was due to higher cash balances invested in marketable securities during the first quarter of 2023 due to our equity offering and higher interest rates in the three months endedMarch 31, 2023 , as compared to the same period of 2022. Interest Expense. Interest expense increased by$0.3 million , or 35.1%, for the three months endedMarch 31, 2023 as compared to the same period of 2022. The increase in interest expense was due to higher debt balances as a result of the debt refinancing in the second quarter of 2022 slightly offset by lower interest rates on our outstanding debt in the three months endedMarch 31, 2023 , as compared to the same period of 2022. 21 --------------------------------------------------------------------------------
Liquidity and Capital Resources
Overview
Before our IPO, our primary sources of capital were private placements of common stock and convertible preferred stock, debt financing agreements and revenue from the sale of our products. InApril 2021 , we received net proceeds of$107.6 million from our IPO. InApril 2022 , we entered a new five-year$150.0 million loan arrangement, consisting of up to$120.0 million in term loans and up to$30.0 million in a revolving loan facility with entities affiliated with MidCap. On the closing date inApril 2022 , we borrowed$50.0 million under the term loan and$4.0 million under the revolving loan facility. The term loan proceeds were partly used to repay our term loan obligation with CRG and an early termination fee to SVB amounting to$34.1 million , including principal of$30.0 million , interest of$0.4 million and fees of$3.7 million . There was no outstanding principal at termination of the SVB revolving loan facility. OnFebruary 10, 2023 , we completed a follow-on public offering of 5,476,190 shares of our common stock, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of$21.00 per share. This offering resulted in net proceeds of$107.5 million after deducting underwriting discounts and commissions of$6.9 million and offering expenses of$0.6 million . As ofMarch 31, 2023 , we had cash and cash equivalents of$29.6 million and marketable securities of$141.0 million available for sale, an accumulated deficit of$98.2 million and$54.0 million principal outstanding under the term and revolving loans with MidCap. We believe that our existing cash and cash equivalents, marketable securities and available debt borrowings and expected revenues will be sufficient to meet our capital requirements and fund our operations for at least twelve months from the issuance of our condensed financial statements. We may be required or decide to raise additional financing to support further growth of our operations.
Funding Requirements
We use our cash to fund our operations, which primarily include the costs of manufacturing our Lapiplasty and Adductoplasty Systems and ancillary products, as well as our sales and marketing and R&D expenses and related personnel costs. We expect our sales and marketing expenses to increase for the foreseeable future as we continue to invest in our direct sales force and expand our marketing efforts, and as we continue to expand our sales and marketing infrastructure to both drive and support anticipated sales growth. We also expect R&D expenses to increase for the foreseeable future as we continue to hire personnel and invest in next-generation innovations of the Lapiplasty System and related products. In addition, we expect our general and administrative expenses to increase for the foreseeable future as we hire personnel and expand our infrastructure to both drive and support the anticipated growth in our organization. We will also incur additional expenses as a result of operating as a public company. From time to time, we may also consider additional investments in technologies, assets, and businesses to expand or enhance our product offerings. The timing and amount of our operating expenditures will depend on many factors, including:
•
the scope and timing of our investment in our commercial infrastructure and
sales force;
•
the costs of our ongoing commercialization activities including product sales,
marketing, manufacturing, and distribution;
•
the scope of our marketing efforts, including the degree to which we utilize
direct to consumer campaigns;
•
the degree and rate of market acceptance of the Lapiplasty and Adductoplasty
Systems and our ancillary products;
•
the costs of filing, prosecuting, defending, and enforcing any patent claims and
other intellectual property rights, including enforcing our intellectual
property rights against infringing products or technologies or enforcing
contractual rights against parties breaching agreements with us;
•
our need to implement additional infrastructure and internal systems;
•
the research and development activities we intend to undertake in order to
improve the Lapiplasty System and to develop or acquire additional products;
•
the investments we make in acquiring other technologies, assets, or businesses
to expand our product portfolio;
•
the success or emergence of new competing technologies or other adverse market
developments;
•
any product liability or other lawsuits related to our products;
•
the expenses needed to attract and retain skilled personnel;
22 --------------------------------------------------------------------------------
•
the costs associated with being a public company;
•
the impact of the COVID-19 pandemic, hospital staffing shortages, delays of
elective procedures; and
•
inflation, interest rate changes, banking sector instability, and other general
economic conditions on our operations and business.
Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. We have based this estimate on assumptions that may prove to be wrong or that may change in the future, and we could utilize our available capital resources sooner than we expect. We may seek to raise any necessary additional capital through public or private equity offerings or debt financings, credit or loan facilities or a combination of one or more of these or other funding sources. Additional funds may not be available to us on acceptable terms or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, we could be forced to delay, limit, reduce or terminate our product development programs, commercialization efforts, sales and marketing initiatives, or other operations. If we raise additional funds by issuing equity securities, our stockholders will suffer dilution, and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.
Cash Flows
The following table sets forth the primary sources and uses of cash and cash
equivalents for the period presented below (in thousands):
Three Months
Ended
2023
2022
Net cash (used in) provided by: Operating activities$ (17,259 ) $ (7,241 ) Investing activities (80,480 ) (1,481 ) Financing activities 107,879 1,372
Net increase (decrease) in cash and cash equivalents
$ (7,350 )
Net cash used in operating activities for the three months endedMarch 31, 2023 was$17.3 million , consisting primarily of a net loss of$13.5 million , adjusted for non-cash charges of$4.0 million and an increase in net operating assets. The non-cash charges consist primarily of share-based compensation expense of$2.7 million , depreciation and amortization expense of$0.9 million and non-cash lease expense of$0.6 million . The increase in net operating assets was primarily due to a decrease in accounts payable and accrued liabilities of$7.7 million during the first quarter due to timing of payments, an increase of$3.2 million in inventories for added safety stock to meet demand for new products and to avoid potential supply chain issues and a$1.0 million increase in prepaid expenses and other current assets, which were partially offset by a$3.8 million decrease in accounts receivable from collections of higher sales in the fourth quarter of 2022. Net cash used in operating activities for the three months endedMarch 31, 2022 was$7.2 million , consisting primarily of a net loss of$9.0 million , which was partially offset by non-cash charges of$1.8 million . The non-cash charges primarily consisted of depreciation and amortization expense of$0.3 million and share-based compensation of$1.4 million .
Net cash used in investing activities was$80.5 million for the three months endedMarch 31, 2023 , consisting primarily of$99.6 million in purchases of marketable securities available for sale and$1.5 million in purchases of property and equipment, partially offset by$20.5 million in maturities of marketable securities available for sale. The purchases of marketable securities were the result of cash invested from our public offering of common stock during the three months endedMarch 31, 2023 . The purchases in property and equipment were$0.6 million in capitalized surgical instruments for our reusable instrument trays and$0.9 for new equipment purchased to support the growth of our business. 23 --------------------------------------------------------------------------------
Net cash used in investing activities was
ended
instruments for our reusable instrument trays.
Net Cash Provided by Financing Activities
Net cash provided in financing activities was$107.9 million for the three months endedMarch 31, 2023 , consisting primarily of$107.5 million of net cash proceeds from our public offering of common stock and$0.4 million from exercise of stock options. Net cash provided in financing activities was$1.4 million for the three months endedMarch 31, 2022 , consisting primarily of proceeds from exercise of stock options.
Surgeon Advisory Board Royalty Agreements
We recognized royalty expense of$1.6 million and$1.4 million for the three months endedMarch 31, 2023 and 2022, respectively. For the three months endedMarch 31, 2023 and 2022, the aggregate royalty rate was 3.9% and 4.8%, respectively. Each of the royalty agreements with our surgeon advisory board members prohibits the payment of royalties on products sold to entities and/or individuals with whom any of the surgeon advisors is affiliated.
Operating Lease
We have commitments for future payments related to our real estate leases located inPonte Vedra, Florida . We entered into a 10-year lease inFebruary 2022 for our new corporate headquarters location. Lease payments comprise the base rent stated in the lease plus operating costs which include taxes, insurance, and common area maintenance. The remaining lease obligation was$25.4 million under these leases as ofMarch 31, 2023 .
Critical Accounting Policies and Estimates
Management's discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles. The preparation of these condensed financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses, and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. Our critical accounting policies and estimates are described in "Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Estimates" in our Annual Report. There had been no material changes to these accounting policies during the three months endedMarch 31, 2023 .
Recently Issued Accounting Pronouncements
Refer to Note 3, "Recent Accounting Pronouncements", to our condensed financial statements included elsewhere in this Quarterly Report for accounting pronouncements adopted as of this Quarterly Report. There have been no newly issued accounting pronouncements impacting the Company's unaudited interim financial statements.
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