Amarin Reports Third Quarter 2018 Financial Results and Provides Update on Operations
Activities Underway to Support Planned Commercial Expansion
Management to Host Conference Call at
- R&D progress: The Vascepa® (icosapent ethyl) cardiovascular outcomes study, REDUCE-IT™, reported topline results on
September 24, 2018. REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance (p<0.001), in major adverse cardiovascular events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo. Additional details regarding these important results are scheduled for presentation on November 10th at the 2018 Scientific Sessions of the American Heart Association(AHA) in Chicago, Illinois.
- Commercial expansion: Through hiring and internal promotion, in late September,
Amarinexpanded its sales management team and accelerated actions to expand its U.S. direct sales force from approximately 150 to approximately 400 sales representatives. The company is on-track for having these new representatives hired and trained before the start of 2019 while in parallel working to expand other Vascepa related promotional activities, market education programs and further increase Vascepa supply capacity.
- Q3 revenue and prescription growth: Recognized
$55.0 millionin net product revenue from U.S. sales of Vascepa in Q3 2018 compared to $47.1 millionin Q3 2017, an increase of 17%. Increased normalized prescriptions for Vascepa in the U.S. by 19% and 22% compared to Q3 2017 based on data from Symphony Health Solutions and IQVIA, respectively. Amarindoes not believe that these results for the quarter ended September 30, 2018 were impacted by announcement in the last week of September 2018 of the topline results of the REDUCE-IT study.
- Capital resources: As of September 30, 2018,
Amarinreported $81.9 millionin cash, $47.6 millionin net accounts receivable, $25.7 millionin other receivables and $43.7 millionin inventory.
- Debt eliminated: Pursuant to a debt exchange announced on October 19, 2018, effective November 2, 2018, the company will no longer have any debt obligation with a fixed maturity date and will no longer have interest payments associated with such debt. The company’s royalty-like obligation remains to be paid at a rate of 10% of Vascepa revenues until the aggregate remaining obligation of
$94.1 millionis satisfied.
“The landmark results of the REDUCE-IT study present an important opportunity to improve the practice of medicine with respect to preventative cardiovascular care. We believe that these outcomes study results position Vascepa to address a significant unmet medical need and could be considered the most significant breakthrough in preventative cardiovascular care since the advent of statin therapy decades ago. We are very excited about the potential for Vascepa to help millions of patients and we are acting accordingly to expand on our established commercial foundation, including existing broad managed care coverage and extensive key opinion leader support,” stated
REDUCE-IT Cardiovascular Outcomes Study
As previously announced, the REDUCE-IT outcomes study was designed to assess the putative cardiovascular effects of the prescription drug Vascepa at 4 grams/day in lowering the risk of cardiovascular events beyond LDL (“bad”) cholesterol management in patients with cardiovascular risk factors including elevated triglycerides. While the study enrolled patients with elevated triglyceride levels (≥135 mg/dL, median baseline 216 mg/dL), REDUCE-IT was a cardiovascular outcomes study and not a lipid-focused study.
Various prior therapies have sought to address the residual cardiovascular risk beyond bad cholesterol management and have failed, including CETP inhibitors, fibrates, nicotinic acid and omega-3 mixtures. Many of these therapies lower triglyceride levels but failed to demonstrate cardiovascular risk reduction in studied populations. The molecular structure and clinical effects and profile of Vascepa are unique.
Data supporting the unique effects of Vascepa was accentuated during Q3 2018 when the report of the successful topline results of the REDUCE-IT cardiovascular outcomes study with Vascepa were announced shortly after cardiovascular outcomes study results were reported for prescription drug Lovaza® (named Omacor in
Vascepa, as a single molecule active ingredient drug, does not contain DHA and has been shown in prior studies to not increase bad cholesterol in relevant patient populations. Patients in the REDUCE-IT study were enrolled with baseline median LDL cholesterol of 75 mg/dL controlled by statin therapy. In addition, omega-3 molecules are fragile and highly prone to oxidation (spoilage typically evidenced by a fishy smell) or other forms of degradation that can impact their effect and safety. Vascepa is manufactured through a stringent and complex
Until the AHA presentation, as agreed with AHA,
- Efficacy: Approximately 25% relative risk reduction, demonstrated to a high degree of statistical significance (p<0.001), in the primary endpoint composite of the first occurrence of MACE, including cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. This result was supported by robust demonstrations of efficacy across multiple secondary endpoints. No further information regarding the secondary endpoint results will be provided until the AHA presentation.
- Safety: Vascepa was well tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current
FDA-approved labeling. The proportions of patients experiencing adverse events and serious adverse events in REDUCE-IT were similar between the active and placebo treatment groups. Median follow-up time in REDUCE-IT was 4.9 years.
The REDUCE-IT cardiovascular outcomes study started in 2011. Prior to knowing the results of this important study,
At the start of 2018, preparing for REDUCE-IT success,
Net product revenue for the three months ended September 30, 2018 and 2017 was
During the third quarter, based on data from Symphony Health Solutions and
Net pricing of Vascepa in the third quarter of 2018 was relatively consistent with the prior year and channel inventory levels remain in the ordinary range.
Licensing revenue during the three months ended September 30, 2018 and 2017 was
Cost of goods sold during the nine months ended September 30, 2018 and 2017 was
Selling, general and administrative (SG&A) expense for the nine months ended September 30, 2018 and 2017 was
Research and development (R&D) expense for the nine months ended September 30, 2018 and 2017 was
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 September 30, 2018, the company had
As of September 30, 2018,
Conference Call and Webcast Information
Amarin will host a conference call at 7:30 a.m. ET today, November 1, 2018. The call will be webcast live with slides and accessible through the investor relations section of the company’s website at www.amarincorp.com. The call can also be heard via telephone by dialing 877-407-8033. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010 (inside
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.
The REDUCE-IT cardiovascular outcomes study commenced in 2011, enrolled and followed 8,179 randomized patients, and was conducted based on a special protocol assessment agreement with
REDUCE-IT is the first global cardiovascular outcomes study to prospectively evaluate the effect of Vascepa, or any therapy, 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 TGs between 150-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention cohort). The design of the REDUCE-IT cardiovascular outcomes study was published in March 2017 in Clinical Cardiology1 and can be found in the R&D section on the company’s website at www.amarincorp.com.
The REDUCE-IT hypothesis tested whether additional cardiovascular risk reduction beyond LDL-C controlled with statin therapy could be achieved in high risk patients with the putative cardioprotective effects of Vascepa 4 grams/day. Independent of REDUCE-IT,
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
FDAat 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
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
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. 9, 10, 11, 12
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 in early 2019 seeking an expanded indication for Vascepa in
Availability of Other Information About Amarin
Investors and others should note that
1 Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif J-C, Ketchum SB, Doyle RT Jr,
2 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.
3 Borow KM, Nelson JR, Mason RP. Biologic plausibility, cellular effects, and molecular mechanisms of eicosapentaenoic acid (
4 Nelson JR, Wani O, May HT, et al. Potential benefits of eicosapentaenoic acid on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.
5 Mason RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acid improves endothelial function and nitric oxide bioavailability in a manner that is enhanced in combination with a statin. Biomed Pharmacother. 2018;103:1231-1237.
6 Takamura M, Kurokawa K, Ootsuji H, et al. Long-term administration of eicosapentaenoic acid improves post-myocardial infarction cardiac remodeling in mice by regulating macrophage polarization.
9 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
10 Toth PP, Granowitz C, Hull M, et al. High triglycerides increase cardiovascular events, medical costs, and resource utilization in a real-world analysis of statin-treated patients with high cardiovascular risk and well-controlled low-density lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl 1):A15187.
11 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
12 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
In U.S.: +1 (646) 378-2992
In U.S.: +1 (646) 280-5210
|CONSOLIDATED BALANCE SHEET DATA|
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||81,892||$||73,637|
|Accounts receivable, net||47,648||45,318|
|Prepaid and other current assets||2,935||3,455|
|Total current assets||202,402||153,270|
|Property, plant and equipment, net||69||28|
|Other long-term assets||174||174|
|Intangible asset, net||7,642||8,126|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Accrued expenses and other current liabilities||93,899||58,902|
|Current portion of exchangeable senior notes, net of discount||219||481|
|Current portion of long-term debt from royalty-bearing instrument||30,130||22,348|
|Deferred revenue, current||1,220||1,644|
|Total current liabilities||151,642||108,530|
|Exchangeable senior notes, net of discount||29,159||28,992|
|Long-term debt from royalty-bearing instrument||53,924||70,834|
|Deferred revenue, long-term||19,736||17,192|
|Other long-term liabilities||8,652||1,150|
|Additional paid-in capital||1,057,408||977,866|
|Total stockholders’ deficit||(52,826||)||(65,100||)|
|TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT||$||210,287||$||161,598|
|CONSOLIDATED STATEMENTS OF OPERATIONS DATA|
|Three months ended September 30,||Nine months ended September 30,|
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Product revenue, net||$||54,973||$||47,051||$||151,286||$||126,343|
|Total revenue, net||55,323||47,360||151,884||127,238|
|Less: Cost of goods sold||13,541||11,921||37,035||31,520|
|Selling, general and administrative (1)||49,960||33,194||147,310||98,910|
|Research and development (1)||14,072||10,694||43,993||35,211|
|Total operating expenses||64,032||43,888||191,303||134,121|
|Interest expense, net||(2,163||)||(2,401||)||(6,188||)||(7,097||)|
|Other (expense) income, net||(58||)||25||(134||)||100|
|Loss from operations before taxes||(24,471||)||(10,825||)||(82,776||)||(45,400||)|
|(Provision for) benefit from income taxes||—||—||—||—|
|Loss per share:|
|Weighted average shares:|
|(1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were $44,357 and $30,223 for the three months ended September 30, 2018 and 2017, respectively, and research and development expenses were $13,024 and $10,170, 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 $33,200 and $24,295 for the three months ended September 30, 2018 and 2017, respectively.|
|RECONCILIATION OF NON-GAAP NET LOSS|
|Three months ended September 30,
||Nine months ended September 30,|
|(in thousands, except per share amounts)
||(in thousands, except per share amounts)|
|Net loss for EPS1 - GAAP||$||(24,471||)||$||(10,825||)||$||(82,776||)||$||(45,400||)|
|Non-cash stock-based compensation expense||6,651||3,495||14,032||10,471|
|Adjusted net loss for EPS1 - non-GAAP||$||(17,820||)||$||(7,330||)||$||(68,744||)||$||(34,929||)|
|1basic and diluted|
|Loss per share:|
|Basic and diluted - non-GAAP||$||(0.06||)||$||(0.03||)||$||(0.24||)||$||(0.13||)|
|Weighted average shares:|
|Basic and diluted||295,595||270,803||291,526||270,566|
Source: Amarin Corporation plc