Amarin Reports Record Fourth Quarter and Full Year 2018 Financial Results and Provides Update on Operations
Record Revenue of
REDUCE-IT™ sNDA Submission Remains on Schedule to be Filed Before the End of Q1 2019
Management to Host Conference Call at
Key
- Unprecedented positive clinical trial: Results of the REDUCE-IT™ cardiovascular outcomes study of Vascepa® demonstrated, compared to placebo, a 25% reduction in major adverse cardiovascular events, with a number needed to treat of 21, and including a 20% reduction in cardiovascular death.1 These results are the largest shown as an add-on to statin therapy by any therapy in any studied patient population. This important result, recognized by the Journal Watch Cardiology section of
The New England Journal of Medicine as the top story of 2018, positions Vascepa to potentially help millions of patients.
- Revenue growth: Net total revenue, the majority of which was recorded prior to REDUCE-IT results, reached a record level of
$229.2 million in 2018, including net total revenue of$77.3 million in the fourth quarter of 2018. The results represent increases of approximately 27% and 44% for full year and fourth quarter of 2018 over the corresponding periods of 2017, respectively, primarily reflecting Vascepa prescription growth.
- Commercialization evolution:
Amarin began its transition from a U.S. sales presence with a relatively small specialty sales team reliant on a co-promotion partner promoting Vascepa based on biomarker data to a broader direct sales model with more sales representatives, more physician targets and promotion which includes reference to cardiovascular outcomes study results. Further promotional expansion, particularly consumer-based promotion, is anticipated following label expansion for Vascepa based on the REDUCE-IT study results.
- Strengthened balance sheet: At
December 31, 2018 ,Amarin had$249.2 million of cash and cash equivalents.
“The tremendous progress
Guidance Reaffirmed
- sNDA Submission: Based on the unprecedented results from the REDUCE-IT cardiovascular outcomes study,
Amarin intends to submit a supplemental new drug application (sNDA) to theU.S. Food and Drug Administration (FDA ) seeking labeling for Vascepa which reflects the cardiovascular risk reduction results demonstrated in this landmark study.Amarin remains on-track to submit this sNDA before the end of the first quarter of 2019 (i.e. before the end ofMarch 2019 ) with a normal 10-month regulatory review period assumed prior to a PDUFA date. While priority review for this sNDA is not currently assumed, after the sNDA is submitted, consistent withFDA practices,Amarin will seek to clarify whether priority review by theFDA is possible for this important submission. Amarin’s sNDA will consist of over 200,000 pages of data, all of which is undergoing extensive medical, statistical and quality review.
- 2019 Revenue: Net total revenue for 2019 is anticipated to increase by more than 50% over 2018 to approximately
$350 million , mostly from U.S. sales of Vascepa.Amarin believes that continued quarterly variability in revenues is likely. This guidance assumes that the timing of the expanded label for Vascepa whichAmarin is seeking, subject toFDA approval, will not be available until late 2019 or early 2020 such that the expanded label has little or no impact on revenue growth in 2019.
Prescription Growth
Normalized prescriptions for Vascepa (prescription of 120 grams of Vascepa representing a one-month supply) increased by 25% and 27% in 2018 compared to 2017 based on data from
Sales Force Expansion
Prior to topline results from the REDUCE-IT study which became available in
Scientific Publication
During 2018,
Results from Amarin’s earlier phase 3 studies of Vascepa, the MARINE and ANCHOR studies, resulted in multiple years of scientific publications. Similarly,
In early 2019, we already witnessed additional publication of scientific study of the mechanism of action of Vascepa and the acceptance of various scientific posters for presentation at the upcoming
Financial Update
Net product revenue for the years ended
In addition,
Cost of goods sold for the three months ended
Selling, general and administrative expenses for the years ended
Research and development expenses for the years ended
Under U.S. GAAP,
Under U.S. GAAP,
Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net loss was
Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net loss was
As of
As of
Conference Call and Webcast Information
The conference call can be heard live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within
Use of Non-GAAP Adjusted Financial Information
Included in this press release are non-GAAP adjusted financial information as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure most directly comparable to each non-GAAP adjusted financial measure used or discussed, and a reconciliation of the differences between each non-GAAP adjusted financial measure and the comparable GAAP financial measure, is included in this press release after the condensed consolidated financial statements.
Non-GAAP adjusted net loss was derived by taking GAAP net loss and adjusting it for non-cash stock-based compensation 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
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.4
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease. 5, 6, 7, 8
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as
Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA -1088. - Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
Forward-Looking Statements
This press release contains forward-looking statements, including expectations regarding planned scientific presentation, publication, regulatory review and related timing thereof, including plans to submit an sNDA before the end of
Availability of Other Information About Amarin
Investors and others should note that
References
1 Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM, for the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
2
3
4 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.
5 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
6 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.
7 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
8 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com (investor inquiries)
PR@amarincorp.com (media inquiries)
Solebury Trout
In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
CONSOLIDATED BALANCE SHEET DATA | ||||||||
(U.S. GAAP) | ||||||||
Unaudited* | ||||||||
December 31, 2018 | December 31, 2017 | |||||||
(in thousands) | ||||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 249,227 | $ | 73,637 | ||||
Restricted cash | 1,500 | 600 | ||||||
Accounts receivable, net | 66,523 | 45,318 | ||||||
Inventory | 57,802 | 30,260 | ||||||
Prepaid and other current assets | 2,945 | 3,455 | ||||||
Total current assets | 377,997 | 153,270 | ||||||
Property, plant and equipment, net | 63 | 28 | ||||||
Other long-term assets | 174 | 174 | ||||||
Intangible asset, net | 7,480 | 8,126 | ||||||
TOTAL ASSETS | $ | 385,714 | $ | 161,598 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 37,632 | $ | 25,155 | ||||
Accrued expenses and other current liabilities | 84,171 | 58,902 | ||||||
Current portion of exchangeable senior notes, net of discount | — | 481 | ||||||
Current portion of long-term debt from royalty-bearing instrument | 34,240 | 22,348 | ||||||
Deferred revenue, current | 1,220 | 1,644 | ||||||
Total current liabilities | 157,263 | 108,530 | ||||||
Long-Term Liabilities: | ||||||||
Exchangeable senior notes, net of discount | — | 28,992 | ||||||
Long-term debt from royalty-bearing instrument | 46,108 | 70,834 | ||||||
Deferred revenue, long-term | 19,490 | 17,192 | ||||||
Other long-term liabilities | 10,523 | 1,150 | ||||||
Total liabilities | 233,384 | 226,698 | ||||||
Stockholders’ Equity (Deficit): | ||||||||
Preferred Stock | 21,850 | 24,364 | ||||||
Common stock | 246,663 | 208,768 | ||||||
Additional paid-in capital | 1,282,762 | 977,866 | ||||||
Treasury stock | (10,413 | ) | (4,229 | ) | ||||
Accumulated deficit | (1,388,532 | ) | (1,271,869 | ) | ||||
Total stockholders’ equity (deficit) | 152,330 | (65,100 | ) | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | 385,714 | $ | 161,598 | ||||
* Unaudited as standalone schedule; copied from consolidated financial statements. | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS DATA | |||||||||||||||||
(U.S. GAAP) | |||||||||||||||||
Unaudited | Unaudited* | ||||||||||||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||||||||||||
(in thousands, except per share amounts) | (in thousands, except per share amounts) | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Product revenue, net | $ | 77,085 | $ | 53,482 | $ | 228,371 | $ | 179,825 | |||||||||
Licensing revenue | 245 | 384 | 843 | 1,279 | |||||||||||||
Total revenue, net | 77,330 | 53,866 | 229,214 | 181,104 | |||||||||||||
Less: Cost of goods sold | 17,509 | 13,432 | 54,543 | 44,952 | |||||||||||||
Gross margin | 59,821 | 40,434 | 174,671 | 136,152 | |||||||||||||
Operating expenses: | |||||||||||||||||
Selling, general and administrative (1) | 79,686 | 35,639 | 226,996 | 134,549 | |||||||||||||
Research and development (1) | 11,906 | 11,947 | 55,900 | 47,158 | |||||||||||||
Total operating expenses | 91,592 | 47,586 | 282,896 | 181,707 | |||||||||||||
Operating loss | (31,771 | ) | (7,152 | ) | (108,225 | ) | (45,555 | ) | |||||||||
Interest expense, net | (1,611 | ) | (2,240 | ) | (7,798 | ) | (9,337 | ) | |||||||||
Other (expense) income, net | (192 | ) | (26 | ) | (326 | ) | 74 | ||||||||||
Loss from operations before taxes | (33,574 | ) | (9,418 | ) | (116,349 | ) | (54,818 | ) | |||||||||
Provision for income taxes (2) | (96 | ) | (13,047 | ) | (96 | ) | (13,047 | ) | |||||||||
Net loss | $ | (33,670 | ) | $ | (22,465 | ) | $ | (116,445 | ) | $ | (67,865 | ) | |||||
Loss per share: | |||||||||||||||||
Basic | $ | (0.11 | ) | $ | (0.08 | ) | $ | (0.39 | ) | $ | (0.25 | ) | |||||
Diluted | $ | (0.11 | ) | $ | (0.08 | ) | $ | (0.39 | ) | $ | (0.25 | ) | |||||
Weighted average shares outstanding: | |||||||||||||||||
Basic | 314,183 | 270,906 | 297,237 | 270,652 | |||||||||||||
Diluted | 314,183 | 270,906 | 297,237 | 270,652 | |||||||||||||
* Unaudited as standalone schedule; copied from consolidated financial statements. | |||||||||||||||||
(1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were $211,088 and $122,711 for 2018 and 2017, respectively, and research and development expenses were $53,002 and $45,036, respectively, for the same periods. Excluding non-cash stock-based compensation as well as co-promotion fees paid to the company's U.S. co-promotion partner, selling, general and administrative expenses were $164,267 and $100,204 for 2018 and 2017, respectively. | |||||||||||||||||
(2) Included in the provision for the year ended December 31, 2017 is non-cash tax expense related to increases in our valuation allowance against deferred tax assets. | |||||||||||||||||
RECONCILIATION OF NON-GAAP NET LOSS | |||||||||||||||||
Unaudited | |||||||||||||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||||||||||||
(in thousands, except per share amounts) | (in thousands, except per share amounts) | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Net loss for EPS1 - GAAP | $ | (33,670 | ) | $ | (22,465 | ) | $ | (116,445 | ) | $ | (67,865 | ) | |||||
Non-cash stock-based compensation expense | 4,775 | 3,489 | 18,806 | 13,960 | |||||||||||||
Adjusted net loss for EPS1 - non-GAAP | $ | (28,895 | ) | $ | (18,976 | ) | $ | (97,639 | ) | $ | (53,905 | ) | |||||
1basic and diluted | |||||||||||||||||
Loss per share: | |||||||||||||||||
Basic and diluted - non-GAAP | $ | (0.09 | ) | $ | (0.07 | ) | $ | (0.33 | ) | $ | (0.20 | ) | |||||
Weighted average shares: | |||||||||||||||||
Basic and diluted | 314,183 | 270,906 | 297,237 | 270,652 | |||||||||||||
Source: Amarin Corporation plc