Amarin Reports First Quarter 2017 Financial Results and Provides Update on Operations
Prescription Growth Up > 50%; Outcomes Study Beyond 80% Complete
Re-affirms Guidance on Full Year Net Product Revenues of between
Management to Host Conference Call at
U.S.revenue growth: Recognized $34.3 millionin net product revenue from Vascepa® (icosapent ethyl) sales in Q1 2017 compared to $25.3 millionin Q1 2016, an increase of 36%. U.S.prescription growth: Increased normalized prescriptions for Vascepa by 52% and 58% compared to Q1 2016 based on data from Symphony Health Solutionsand IMS Health, respectively.
- International development:
Chinaregulatory authorities approved the Vascepa clinical trial application (CTA) from Amarin's partner, Eddingpharm, paving the way for Eddingpharmto commence a clinical trial of Vascepa in Chinabefore the end of 2017.
- R&D progress: Our REDUCE-IT cardiovascular outcomes study, designed to provide data to support a significantly expanded market opportunity for Vascepa, is progressing as planned. Our statistical models indicate that in
March 2017, the study reached the onset of approximately 80% of the target aggregate number of primary cardiovascular events. The onset of the target final primary cardiovascular event will likely be reached near the end of 2017 in this 8,175 patient study that commenced in 2011.
- Cash flow: Net cash outflow from operations during Q1 2017 was less than
$1.5 million, excluding costs for R&D, interest and royalty. The company aims to be net cash flow positive on this basis for the full year with continued quarterly variability.
- Cash balance: As of
March 31, 2017, Amarin had a cash balance of $96.1 millioncompared to $98.3 millionat December 31, 2016. The March 31st cash balance includes approximately $13.7 millionin net cash proceeds from the January 2017redemption of debt and simultaneous issuance of $30.0 millionface value of new debt long-term.
"Historically, Q1 has been our most challenging quarter for revenue growth due to seasonal factors. We are pleased that both revenues and prescriptions for Vascepa grew significantly in Q1, as prescription growth exceeded our internal projections. We are on-track to achieve our full year 2017 product revenue guidance of
Increases in New and Recurring Prescriptions Drive Steady Commercial Growth
During the first quarter, Amarin again experienced substantial prescription growth and continued increase in Vascepa market share, particularly among detailed physicians. Overall, approximately 150,000 patients received prescriptions for Vascepa during the quarter, with new prescriptions growing to approximately 5% of the non-statin lipid modifying market and approaching 30% of the prescription omega-3 market. Strong Vascepa growth is driven by positive physician experience in conjunction with our focused message delivery, compelling efficacy and safety data, and improved managed care coverage.
Estimated normalized total Vascepa prescriptions, based on data from
During the first quarter of 2017, overall wholesaler inventory levels decreased from year-end 2016 levels calculated based on estimated days of Vascepa sales on hand. Consequently, we estimate that this decrease in wholesaler inventory levels adversely impacted net product revenue by approximately
REDUCE-IT Cardiovascular Outcomes Study
The REDUCE-IT cardiovascular outcomes trial continues to progress on schedule. Amarin anticipates the onset of the final primary cardiovascular event to occur near the end of 2017, with report of top-line results and publications in 2018. The projected timing of available data from which we can report top-line results should be easier to estimate after the interim look which, as discussed below, is scheduled to complete in Q3 2017. We currently estimate that we will report results of REDUCE-IT in mid-2018, assuming the study goes to completion. These estimates reflect our assumptions of the necessary time needed to collect vital data from all patients in the study, compile the results, and subject the results to scrutiny of the independent review committees and the REDUCE-IT operational team.
The 8,175-patient outcomes study is evaluating whether treatment with Vascepa reduces cardiovascular events in patients who despite stabilized statin therapy, have elevated triglyceride levels and other cardiovascular risk factors. The results of this important trial, if successful, could lead to improved medical care for tens of millions of patients. Amarin is positioned to be the first company to complete an outcomes study in the population of patients being studied in REDUCE-IT.
The primary endpoint of this global, double-blind study is the time to the first occurrence of a composite of major adverse cardiovascular events (MACE). Results will be compared between the Vascepa and placebo groups. The study is being conducted under a Special Protocol Assessment (SPA) agreement with the
Preparations are underway for a second pre-specified interim efficacy and safety analysis of REDUCE-IT by the independent
Amarin will remain blinded to results of the REDUCE-IT study until after the study is stopped and the database is locked at either the 80% interim analysis or at the final analysis.
International Development of Vascepa
Our international initiatives are progressing
positively. Our partner for
Net product revenue for the three months ended
In addition, Amarin recognized licensing revenue of
Cost of goods sold for the three months ended
Selling, general and administrative (SG&A) expenses in the three months ended
Research and development expenses in the three months ended
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, May 3, 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. The call can also be heard 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
- 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 FDA at 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 for continued event rates, interim data review, results and related timing and announcements with respect to Amarin's REDUCE-IT cardiovascular outcomes study; expectations related to the interim and 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||$||96,076||$||98,251|
|Accounts receivable, net||29,450||19,985|
|Prepaid and other current assets||4,785||6,983|
|Total current assets||154,790||146,326|
|Property, plant and equipment, net||69||78|
|Deferred tax assets||11,082||11,082|
|Other long-term assets||652||741|
|Intangible asset, net||8,610||8,772|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accrued expenses and other current liabilities||44,434||37,720|
|Current portion of exchangeable senior notes, net of discount||192||15,351|
|Current portion of long-term debt from royalty-bearing instrument||17,004||15,944|
|Deferred revenue, current||1,197||1,172|
|Total current liabilities||77,944||76,249|
|Exchangeable senior notes, net of discount||28,831||—|
|Long-term debt from royalty-bearing instrument||82,405||85,155|
|Deferred revenue, long-term||13,625||13,943|
|Other long-term liabilities||1,167||710|
|Additional paid-in capital||967,073||964,914|
|Total stockholders' deficit||(28,769||)||(9,058||)|
|TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT||$||175,203||$||166,999|
|CONSOLIDATED STATEMENTS OF OPERATIONS DATA|
|Three Months Ended |
|(in thousands, except per share amounts)|
|Product revenue, net||$||34,344||$||25,307|
|Total revenue, net||34,637||25,543|
|Less: Cost of goods sold||8,198||6,896|
|Selling, general and administrative (1)||34,171||28,020|
|Research and development (1)||10,823||13,730|
|Total operating expenses||44,994||41,750|
|Loss on change in fair value of derivative liabilities (2)||—||(1,250||)|
|Interest expense, net||(2,381||)||(5,586||)|
|Other expense, net||(5||)||(121||)|
|Loss from operations before taxes||(20,941||)||(30,060||)|
|Benefit from income taxes||—||289|
|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 a warrant derivative liability, long-term debt derivative liabilities, and a preferred stock purchase option derivative liability.|
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. SternTrout Group In U.S.: +1 (646) 378-2992 firstname.lastname@example.org
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