Amarin Reports First Quarter 2018 Financial Results and Provides Update on Operations
REDUCE-IT Study On-Track for Reporting Top-Line Results by the End of Q3 2018
Management to Host Conference Call at
- R&D progress: The REDUCE-IT cardiovascular outcomes study, designed to provide data to support a significantly expanded market opportunity for Vascepa® (icosapent ethyl), is estimated to have reached the 100% mark for onset of the 1,612 target primary major adverse cardiovascular events (MACE) specified in the study design. Amarin anticipates that MACE from the study will be adjudicated through Q2 2018, consistent with the company's objective of reporting top-line results from this important study before the end of Q3 2018.
U.S.revenue growth: Recognized $43.8 millionin net product revenue from Vascepa sales in Q1 2018 compared to $34.3 millionin Q1 2017, an increase of 27%. U.S.prescription growth: Increased normalized prescriptions for Vascepa by 25% and 27% compared to Q1 2017 based on data from Symphony Health Solutionsand IQVIA, respectively.
- International development: Announced the first international approval for Vascepa with the regulatory approval of Vascepa in
Lebanon. The clinical trial of Vascepa for approval in Chinais in process.
- Cash balance: As of
March 31, 2018, Amarin had a cash balance of $129.0 million, which includes approximately $70.0 millionin net cash proceeds from the equity offering announced in February 2018, compared to $73.6 millionat December 31, 2017.
"There is tremendous energy and excitement within Amarin currently as we approach the
results of the REDUCE-IT study and prepare for targeted future growth," stated
REDUCE-IT Cardiovascular Outcomes Study
REDUCE-IT is designed to determine if intervention with 4 grams/day of prescription pure EPA Vascepa will lower rates of major adverse cardiovascular events in statin-treated patients with persistent hypertriglyceridemia and other cardiovascular risk factors. Motivated by the vision of Amarin and its scientific collaborators in identifying a large unmet medical need in this important patient population, and facilitated by the differentiation of Vascepa from earlier generation triglyceride-lowering therapies, this is the first ever prospective study of this population with any therapy.
The primary endpoint of this global, double-blind study is the time to the first occurrence of a composite of primary major adverse cardiovascular events (MACE). Results will be compared between the Vascepa and placebo groups. The study was designed to accumulate 1,612 MACE at which level the study was robustly designed to have 90% power to detect a 15% relative risk reduction in MACE between the Vascepa and placebo arms of the study. The study is being conducted under a Special Protocol Assessment
(SPA) agreement with the
As previously reported, Amarin estimates that the onset of approximately 1,612 MACE has occurred. In
Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked. Final patient visits will be followed by completing data entry for the more than 35,000 patient years of study in REDUCE-IT, and typical database quality control measures, known as cleaning. In parallel, adjudication will be completed for all MACE which occurred during the study, including adjudication for certain events which, per protocol, cannot be finally adjudicated until patients complete their final site visit and results are available from certain non-invasive diagnostic testing conducted during such site visits. These steps will be followed by the database lock and final efficacy and safety analyses, including analysis of the trial's primary endpoint of first MACE events in the study, and the analyses of more than thirty pre-defined secondary and tertiary endpoints. Winding down a study of this magnitude to completion typically takes many months. The company believes that it is on track to achieve its objective of reporting top-line results from this important study before the end of Q3 2018.
Net product revenue for the three months ended
During the first quarter, based on data from
The company recognized licensing revenue of
Cost of goods sold for the three months ended
Selling, general and administrative expenses in the three months ended
Research and development expenses in the three months ended
Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net loss was
Amarin reported cash and cash equivalents of
Amarin's partner in the
Conference call and webcast information
Amarin will host a conference call at 7:30 a.m. ET today, May 2, 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
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.
Amarin's clinical development program for Vascepa includes a trial known as the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride-lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (150-499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study are anticipated to also be diagnosed with type 2 diabetes. As reported previously, Amarin expects to announce top-line results of this important study before the end of Q3 2018. The REDUCE-IT trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex
- 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
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- 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.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the
FDAat 1-800- FDA-1088.
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. 3, 4, 5, 6
Leading clinical investigations seeking to address cardiovascular risk reduction beyond lowering LDL-C focus on interrupting the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting other lipid, lipoprotein and inflammation biomarkers and cellular functions thought to be related to atherosclerosis and cardiovascular events.
This press release contains forward-looking statements, including expectations regarding adjudication of MACE events, results and related timing and announcements with respect to Amarin's REDUCE-IT cardiovascular outcomes study; expectations related to the final outcomes of the REDUCE-IT study and the anticipated successful completion of the REDUCE-IT study; and statements regarding the potential and therapeutic benefits of Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in filings with 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,
3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
4 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.
5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease.
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 (212) 583-2791
|CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||129,049||$||73,637|
|Accounts receivable, net||39,180||45,318|
|Prepaid and other current assets||3,618||3,455|
|Total current assets||207,551||153,270|
|Property, plant and equipment, net||20||28|
|Other long-term assets||174||174|
|Intangible asset, net||7,964||8,126|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accrued expenses and other current liabilities||61,311||58,902|
|Current portion of exchangeable senior notes, net of discount||219||481|
|Current portion of long-term debt from royalty-bearing instrument||24,370||22,348|
|Deferred revenue, current||1,453||1,644|
|Total current liabilities||119,230||108,530|
|Exchangeable senior notes, net of discount||29,047||28,992|
|Long-term debt from royalty-bearing instrument||65,480||70,834|
|Deferred revenue, long-term||17,459||17,192|
|Other long-term liabilities||1,150||1,150|
|Additional paid-in capital||1,036,697||977,866|
|Total stockholders' deficit||(16,657||)||(65,100||)|
|TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT||$||215,709||$||161,598|
|CONSOLIDATED STATEMENTS OF OPERATIONS DATA|
|Three months ended |
|(in thousands, except per share amounts)|
|Product revenue, net||$||43,777||$||34,344|
|Total revenue, net||43,919||34,637|
|Less: Cost of goods sold||10,648||8,198|
|Selling, general and administrative (1)||43,407||34,171|
|Research and development (1)||11,762||10,823|
|Total operating expenses||55,169||44,994|
|Interest expense, net||(2,252||)||(2,381||)|
|Other income (expense), net||55||(5||)|
|Loss from operations before taxes||(24,095||)||(20,941||)|
|(Provision for) benefit from income taxes||—||—|
|Loss per share:|
|Weighted average shares outstanding:|
|(1||)||Excluding non-cash stock-based compensation, selling, general and administrative expenses were |
|RECONCILIATION OF NON-GAAP NET LOSS|
|Three months ended |
|(in thousands, except per share amounts)|
|Net loss for EPS1 - GAAP||$||(24,095||)||$||(20,941||)|
|Non-cash stock-based compensation expense||3,762||3,351|
|Adjusted net loss for EPS1 - non-GAAP||$||(20,333||)||$||(17,590||)|
|1basic and diluted|
|Loss per share:|
|Basic and diluted - non-GAAP||$||(0.07||)||$||(0.07||)|
|Weighted average shares:|
|Basic and diluted||285,207||270,163|
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