Amarin Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Go-to-Market Strategy in
European Expansion Strategy On Track with Reimbursement Negotiations and Launch Preparations for VAZKEPA Underway in Multiple Markets
Plans for Regulatory Filings for Approval of VASCEPA in Several Additional Countries in 2022
Company to Host Conference Call Today at
“2021 was a year of significant progress, during which we laid the foundation to support our long-term growth strategy including greater geographic reach for VASCEPA®, expanded operations and pipeline diversification, including a fixed-dose combination portfolio,” stated
“In the
“2022 is slated to be a year of execution for Amarin. We are fully dedicated to maximizing our asset, VASCEPA/VAZKEPA, intend to build on our important cardiovascular outcomes data and progress on our diversification strategy including further development of our fixed-dose combination portfolio. Underlying these initiatives is our commitment to operational excellence including flexible and profitable investments in growth, while maintaining a strong balance sheet. We will continue to enhance our leadership team and board with the right talent to support the company’s next steps. The achievement of these objectives is our highest priority as we seek to attain our bold vision to stop heart disease from being the leading cause of death, worldwide.”
The Go-To-Market strategy is demonstrating progress across all three initiatives:
Continued to Expand Provider Engagement
- Enhanced awareness and use of VASCEPA with optimized sales force and expanded reach to approximately 150,000 healthcare providers.
- Continue evaluating all resources and encouraging pay-for-performance partnerships, such as BlinkRx, elements of Omnichannel and other initiatives
Managed Care Access Remains a Focus
- In
December 2021 , Amarin had approximately 40% of total commercial and Medicare Part D lives on a weighted average basis with VASCEPA as the exclusive IP product. Additional anticipated decisions could positively impact our exclusive coverage level in 2022 beyond the 40%. - Improved access for VASCEPA for 25% of all commercial lives.
Optimizing Fulfillment of VASCEPA Prescriptions for Cardiovascular (CV) Risk Reduction
- Launched new VASCEPA campaign focused on prior myocardial infarction and stroke patients at a heightened risk of a subsequent event to generate immediate growth acceleration.
- Partnered with BlinkRx to support fulfillment process across the continuum of care, to ensure patients can start and remain on VASCEPA.
- Received market approval of VAZKEPA by the
European Commission (EC) and theUK Medicines and Healthcare products regulatory agency (MHRA) as the first and only treatment to reduced CV risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics. - Submitted market access and reimbursement dossiers in ten European countries (namely
Germany ,UK ,Italy ,France ,Spain ,Denmark ,Sweden ,Finland ,Norway , andthe Netherlands ) ahead of plan. - Clinical and Health Technology Assessments processes and reimbursement discussions are progressing in all targeted markets.
- Launched VAZKEPA in
Germany despite resurging COVID-19 disruptions. Progressing commercial launch plans of VAZKEPA in up to six countries as expected, with preparations underway in several key markets. - Actively negotiating partnerships to bring VAZKEPA to Central and Eastern European markets via marketing and distribution agreements with partners who have established infrastructure in such markets
International
- Expects regulatory filings, approvals and potential launches of VASCEPA, via partners, in up to six new countries, including
Australia ,New Zealand , and certainAsia-Pacific markets in 2022.- Received acceptances of VASCEPA for regulatory review in
Australia andIsrael , and has embarked on initiatives to engage a commercial partner to market/distribute the product in this region.
- Received acceptances of VASCEPA for regulatory review in
The National Medical Products Administration , or NMPA, has accepted for review the new drug application for VASCEPA submitted by Edding, Amarin’s partner inChina .- Expects final decisions from the NMPA in Mainland China and from the regulatory authority in
Hong Kong in the second half of 2022.
- Expects final decisions from the NMPA in Mainland China and from the regulatory authority in
- Expanded VASCEPA commercialization in several Middle Eastern countries including
Lebanon ,UAE , andQatar through partners. - Continued execution of international expansion strategy that features plans to bring the CV reduction benefits of VASCEPA/VAZKEPA to approximately 20 additional countries over the course of the next three years through a series of distribution agreements and partnerships1.
- Amarin’s partner in
Canada , HLS Therapeutics, announced a co-promotional agreement for VASCEPA with Pfizer inCanada .
Financial Update
Total net revenue for the full year ended
Amarin recognized licensing and royalty revenue of approximately
Cost of goods sold for the full year ended
Selling, general and administrative expenses for the full year ended
Research and development expenses for the full year ended
Under
Excluding non-cash stock-based compensation expense and restructuring expense, non-GAAP adjusted net income was
As of
As of
Strengthening our Leadership Team and Board of Directors
Amarin expanded its leadership team with the addition of four new executive members.
Laurent Abuaf , Senior Vice President, President EuropeJason Marks , Chief Legal Officer and Corporate SecretaryAlan Wills , Executive Vice President, Corporate Business DevelopmentLisa DeFrancesco , Senior Vice President Investor Relations and Corporate Affairs
The Company also enhanced its board of directors with the appointment of Per Wold-Olsen, who joined the Amarin Board of Directors on
2022 Financial Outlook
Given the uncertainty primarily related to the continued global impact of COVID-19 as well as the uncertainty resulting from the impact of generic availability in the
As noted above,
Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations, including European launch activities.
Conference Call and Webcast Information:
Amarin will host a conference call on
Use of Non-GAAP Adjusted Financial Information
Included in this press release are non-GAAP adjusted financial information as defined by
Non-GAAP adjusted net income was derived by taking GAAP net loss and adjusting it for non-cash stock-based compensation expense and restructuring expense. Management uses these non-GAAP adjusted financial measures for internal reporting and forecasting purposes, when publicly providing its business outlook, to evaluate the company’s performance and to evaluate and compensate the company’s executives. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations.
While management believes that these non-GAAP adjusted financial measures provide useful supplemental information to investors regarding the underlying performance of the company’s business operations, investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the company’s results of operations as determined in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in the future.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world. In
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.ii Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins. iii,iv,v
About REDUCE-IT
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the
Indications and Limitation of Use (in
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT
| VASCEPA | Placebo | VASCEPA vs Placebo |
|||
| N = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
Incidence Rate (per 100 patient years) |
||
| Primary composite endpoint | |||||
| Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE) | 705 (17.2) |
4.3 | 901 (22.0) |
5.7 | 0.75 (0.68, 0.83) |
| Key secondary composite endpoint | |||||
| Cardiovascular death, myocardial infarction, stroke (3-point MACE) | 459 (11.2) |
2.7 | 606 (14.8) |
3.7 | 0.74 (0.65, 0.83) |
| Other secondary endpoints | |||||
| Fatal or non-fatal myocardial infarction | 250 (6.1) |
1.5 | 355 (8.7) |
2.1 | 0.69 (0.58, 0.81) |
| Emergent or urgent coronary revascularization | 216 (5.3) |
1.3 | 321 (7.8) |
1.9 | 0.65 (0.55, 0.78) |
| Cardiovascular death [1] | 174 (4.3) |
1.0 | 213 (5.2) |
1.2 | 0.80 (0.66, 0.98) |
| Hospitalization for unstable angina [2] | 108 (2.6) |
0.6 | 157 (3.8) |
0.9 | 0.68 (0.53, 0.87) |
| Fatal or non-fatal stroke | 98 (2.4) |
0.6 | 134 (3.3) |
0.8 | 0.72 (0.55, 0.93) |
| [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. |
|||||
FULL
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the world-wide market potential for VASCEPA; expectations regarding financial metrics and performance such as prescription growth, revenue growth, operating expenses, inventory purchases, and managed care coverage for VASCEPA, including the impact of the COVID-19 pandemic, the disappointing outcome of patent litigation and the launch of generic competition on these metrics; beliefs that Amarin is well positioned to deliver on its goals to grow VASCEPA in the
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs,
Amarin Contact Information
Investor Inquiries:
[email protected] (investor inquiries)
| CONSOLIDATED BALANCE SHEET DATA | ||||||||
| ( |
||||||||
| Unaudited * | ||||||||
| (in thousands) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 219,454 | $ | 186,964 | ||||
| Restricted cash | 3,918 | 3,915 | ||||||
| Short-term investments | 234,674 | 313,969 | ||||||
| Accounts receivable, net | 163,653 | 154,574 | ||||||
| Inventory | 234,676 | 188,864 | ||||||
| Prepaid and other current assets | 22,352 | 30,947 | ||||||
| Total current assets | 878,727 | 879,233 | ||||||
| Property, plant and equipment, net | 1,425 | 2,016 | ||||||
| Long-term investments | 34,996 | 62,469 | ||||||
| Long-term inventory | 121,254 | — | ||||||
| Operating lease right-of-use asset | 7,660 | 8,054 | ||||||
| Other long-term assets | 456 | 432 | ||||||
| Intangible asset, net | 23,547 | 13,817 | ||||||
| TOTAL ASSETS | $ | 1,068,065 | $ | 966,021 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 114,922 | $ | 105,876 | ||||
| Accrued expenses and other current liabilities | 253,111 | 198,641 | ||||||
| Current deferred revenue | 2,649 | 2,926 | ||||||
| Total current liabilities | 370,682 | 307,443 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term deferred revenue | 14,060 | 15,706 | ||||||
| Long-term operating lease liability | 8,576 | 9,153 | ||||||
| Other long-term liabilities | 7,648 | 6,214 | ||||||
| Total liabilities | 400,966 | 338,516 | ||||||
| Stockholders’ Equity: | ||||||||
| Common stock | 294,027 | 290,115 | ||||||
| Additional paid-in capital | 1,855,246 | 1,817,649 | ||||||
| (60,726 | ) | (51,082 | ) | |||||
| Accumulated deficit | (1,421,448 | ) | (1,429,177 | ) | ||||
| Total stockholders’ equity | 667,099 | 627,505 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 1,068,065 | $ | 966,021 | ||||
| * Unaudited as a standalone schedule; copied from consolidated financial statements | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||||||||||||||||||
| ( |
||||||||||||||||||
| Unaudited * | ||||||||||||||||||
| Three Months Ended |
Year Ended |
|||||||||||||||||
| (in thousands, except per share amounts) |
(in thousands, except per share amounts) | |||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||
| Product revenue, net | $ | 143,722 | $ | 165,907 | $ | 580,320 | $ | 607,025 | ||||||||||
| Licensing and royalty revenue | 769 | 1,344 | 2,867 | 7,035 | ||||||||||||||
| Total revenue, net | 144,491 | 167,251 | 583,187 | 614,060 | ||||||||||||||
| Less: Cost of goods sold | 30,635 | 34,769 | 121,327 | 131,444 | ||||||||||||||
| Gross margin | 113,856 | 132,482 | 461,860 | 482,616 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Selling, general and administrative (1) | 92,368 | 116,816 | 408,334 | 463,312 | ||||||||||||||
| Research and development (1) | 5,753 | 8,508 | 29,307 | 38,959 | ||||||||||||||
| Restructuring | (398 | ) | — | 13,717 | — | |||||||||||||
| Total operating expenses | 97,723 | 125,324 | 451,358 | 502,271 | ||||||||||||||
| Operating income (loss) | 16,133 | 7,158 | 10,502 | (19,655 | ) | |||||||||||||
| Interest income | 195 | 551 | 1,220 | 4,901 | ||||||||||||||
| Interest expense | (23 | ) | (163 | ) | (129 | ) | (2,605 | ) | ||||||||||
| Other income (expense), net | 88 | 54 | (302 | ) | 104 | |||||||||||||
| Income (loss) from operations before taxes | 16,393 | 7,600 | 11,291 | (17,255 | ) | |||||||||||||
| Provision for income taxes | (1,695 | ) | (2,674 | ) | (3,562 | ) | (745 | ) | ||||||||||
| Net income (loss) | 14,698 | 4,926 | 7,729 | (18,000 | ) | |||||||||||||
| Earnings (loss) per share | ||||||||||||||||||
| Basic | $ | 0.04 | $ | 0.01 | $ | 0.02 | $ | (0.05 | ) | |||||||||
| Diluted | $ | 0.04 | $ | 0.01 | $ | 0.02 | $ | (0.05 | ) | |||||||||
| Weighted average shares outstanding: | ||||||||||||||||||
| Basic | 397,049 | 390,661 | 395,992 | 381,759 | ||||||||||||||
| Diluted | 401,768 | 398,963 | 402,480 | 381,759 | ||||||||||||||
| * Unaudited as a standalone schedule; copied from consolidated financial statements | ||||||||||||||||||
| (1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were |
||||||||||||||||||
| RECONCILIATION OF NON-GAAP NET INCOME | |||||||||||||||||
| Unaudited | |||||||||||||||||
| Three months ended |
Year Ended |
||||||||||||||||
| (in thousands, except per share amounts) | (in thousands, except per share amounts) | ||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Net income (loss) for EPS - GAAP | 14,698 | 4,926 | 7,729 | (18,000 | ) | ||||||||||||
| Stock-based compensation expense | 9,796 | 11,508 | 36,632 | 45,814 | |||||||||||||
| Restructuring expense | (398 | ) | — | 13,717 | - | ||||||||||||
| Adjusted net income for EPS - non-GAAP | $ | 24,096 | $ | 16,434 | $ | 58,078 | $ | 27,814 | |||||||||
| basic and diluted | |||||||||||||||||
| Earnings per share: | |||||||||||||||||
| Basic - non-GAAP | $ | 0.06 | $ | 0.04 | $ | 0.15 | $ | 0.07 | |||||||||
| Diluted - non-GAAP | $ | 0.06 | $ | 0.04 | $ | 0.14 | $ | 0.07 | |||||||||
| Weighted average shares: | |||||||||||||||||
| Basic | 397,049 | 390,661 | 395,992 | 381,759 | |||||||||||||
| Diluted | 403,752 | 398,963 | 403,980 | 401,195 | |||||||||||||
i
ii Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343
iii Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145
iv Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740
v Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563
vi Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
vii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
1 The company is pursuing expansion into these various additional markets and the status of regulatory and/or patent approval will vary between market to market.
Source:
Philippines Embedded Finance Markets Report 20222-2029: 50+ KPIs on Embedded Lending, Insurance, Payment, and Wealth Segments – ResearchAndMarkets.com
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