Amarin Reports Second Quarter 2017 Financial Results and Provides Update on Operations
Record-High Net Product Revenue of
Increasing Guidance on Full Year Net Product Revenue to
Management to Host Conference Call at
- Product revenue growth: Recognized
$44.9 millionin U.S.net product revenue from Vascepa® (icosapent ethyl) sales in Q2 2017 compared to $32.8 millionin Q2 2016, an increase of 37%.
U.S.prescription growth: Increased normalized prescriptions for Vascepa by 50% and 52% compared to Q2 2016 based on data from Symphony Health Solutionsand IMS Health, respectively.
- R&D progress: Landmark long-term cardiovascular outcomes study, REDUCE-IT, nearing completion with results expected to be reported in Q2 or Q3 of 2018.
- Cash flow: Net cash flow was modestly positive from operations during three and six months ended
June 30, 2017, excluding cash flow related to R&D and finance (i.e., excluding cash inflows/outflows from debt-related transactions reported in Q1 2017, interest and royalty).
- Cash balance: As of
June 30, 2017, Amarin had a cash balance of $85.5 million.
"We believe evidence continues to mount supporting the potential success of the REDUCE-IT cardiovascular outcomes study and that Amarin is at the forefront of what could become a new era in preventative cardiovascular care. We have also seen increased interest in addressing residual cardiovascular risk beyond controlling LDL-cholesterol, and a greater focus on finding treatments that can help address this risk," stated
Substantial commercial growth continues
Our commercial team again drove new and recurring Vascepa prescription growth in the second quarter of 2017. This growth, which was aided by expanded managed care coverage at the start of 2017, reflects further productivity improvement from our
Estimated normalized total Vascepa prescriptions, based on data from
REDUCE-IT trial status
The REDUCE-IT cardiovascular outcomes trial continues to progress towards reported results in Q2 or Q3 of 2018, assuming the trial is not stopped early. Based on historical event rates, Amarin anticipates the study reaching in early 2018 the onset of 100% of the targeted cumulative total of 1,612 primary major adverse cardiovascular events (MACE). Reaching this events target will be followed by final patient visits to clinical sites, accumulation of final data, including on any primary or other categories of MACE that have been documented and adjudicated, and final efficacy and safety data review by the independent review committees and the REDUCE-IT operational team. After Amarin is unblinded and learns the results of the study, the results will be publicly communicated. Amarin believes that the results of this landmark trial, if successful, could lead to improved preventative medical care for tens of millions of patients and could contribute to significantly lower costs for treating these patients.
REDUCE-IT is the first prospectively conducted, multi-national, double-blinded study to evaluate the effects of treating patients who despite well-controlled LDL-cholesterol have high triglycerides and other risk factors associated with cardiovascular disease. This 8,175-patient study, which commenced in late 2011, has accumulated over 30,000 years of study of treated patients. Amarin seeks to determine whether the potentially broad clinical effects of an intentionally high daily dose (4 grams per day) of Vascepa translate into fewer cardiovascular events for at-risk patients. If successful in demonstrating positive cardiovascular outcomes results, Amarin believes that Vascepa is well-positioned to be prescribed for treatment of at-risk patients due to the efficacy, tolerability, ease of administration and affordable price of Vascepa.
Later in the current quarter (Q3 2017), Amarin anticipates receiving the recommendation of the independent data monitoring committee (DMC) regarding its pre-scheduled interim efficacy and safety analysis. In this analysis, the DMC will review data available from the preparations triggered by the onset of approximately 80% of targeted primary MACE. As is typical in cardiovascular outcomes studies, Amarin expects the DMC to recommend that this important study should continue to completion which, as planned, is expected to provide a more robust result based on the larger number of MACE at the end of the trial. The thresholds for early trial stoppage due to overwhelming efficacy are intentionally high with respect to both quantitative and qualitative measures. Amarin is operating with the expectation that the trial will continue to completion.
Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study as well as to any interim p-values and other statistical information until after the study is ready to be stopped and the database is locked, either at the interim analysis or at the final analysis.
Net product revenue for the three months ended
year-to-date results and anticipated trends, Amarin is increasing its guidance estimate for total 2017 net product revenue to
Licensing revenue, which relates to agreements for the commercialization of Vascepa outside
Our gross margin on product sales for the three and six months
Selling, general and administrative expense for the six months ended
Research and development expense for the six months ended
Under GAAP, Amarin reported a net loss of
Under GAAP, Amarin
reported a net loss of
Amarin reported cash and cash equivalents of
Conference call and webcast information
Amarin will host a conference call at 8:00 a.m. ET today, August 2, 2017. The call will be webcast live with slides and accessible through the investor relations section of the
company's website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within
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
FDA-Approved Indication and Usage
- 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
This press release contains forward-looking statements, including expectations regarding revenue growth, spending levels and cash flow as well as REDUCE-IT related expectations for continued event rates, interim data review, results and related timing and announcements; 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 we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
|CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||85,464||$||98,251|
|Accounts receivable, net||37,475||19,985|
|Prepaid and other current assets||2,076||6,983|
|Total current assets||150,429||146,326|
|Property, plant and equipment, net||52||78|
|Deferred tax assets||11,082||11,082|
|Other long-term assets||173||741|
|Intangible asset, net||8,449||8,772|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accrued expenses and other current liabilities||49,102||37,720|
|Current portion of exchangeable senior notes, net of discount||455||15,351|
|Current portion of long-term debt from royalty-bearing instrument||18,833||15,944|
|Deferred revenue, current||1,447||1,172|
|Total current liabilities||86,292||76,249|
|Exchangeable senior notes, net of discount||28,884||—|
|Long-term debt from royalty-bearing instrument||79,283||85,155|
|Deferred revenue, long-term||13,332||13,943|
|Other long-term liabilities||1,158||710|
|Additional paid-in capital||970,797||964,914|
|Total stockholders' deficit||(38,764||)||(9,058||)|
|TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT||$||170,185||$||166,999|
|CONSOLIDATED STATEMENTS OF OPERATIONS DATA|
months ended ||Six months ended |
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Product revenue, net||$||44,948||$||32,815||$||79,292||$||58,122|
|Total revenue, net||45,241||33,111||79,878||58,654|
|Less: Cost of goods sold||11,401||8,861||19,599||15,757|
|Selling, general and administrative (1)||31,545||26,066||65,716||54,086|
|Research and development (1)||13,694||12,578||24,517||26,308|
|Total operating expenses||45,239||38,644||90,233||80,394|
|Gain on change in fair value of derivative liabilities (2)||—||5,810||—||4,560|
|Interest expense, net||(2,315||)||(5,616||)||(4,696||)||(11,202||)|
|Other income (expense), net||80||(182||)||75||(303||)|
|Loss from operations before taxes||(13,634||)||(14,382||)||(34,575||)||(44,442||)|
|Benefit from income taxes||—||1,028||—||1,317|
|Loss per share:|
|Weighted average shares:|
|(1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were |
|(2) Non-cash gains and losses result from changes in the fair value of long-term debt derivative liabilities.|
Amarin contact information: Investor Relations:
Elisabeth SchwartzInvestor Relations and Corporate Communications Amarin Corporation plcIn U.S.: +1 (908) 719-1315 email@example.com Lee M. Stern Trout GroupIn U.S.: +1 (646) 378-2992 firstname.lastname@example.org Media Inquiries: Ovidio Torres Finn PartnersIn U.S.: +1 (312) 329-3911 Ovidio.email@example.com
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