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Amarin (AMRN) Q3 Earnings Beat, Sales Hurt by Vascepa Generics

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Amarin Corporation Plc (AMRN - Free Report) reported adjusted earnings of 2 cents per American depositary share in third-quarter 2022, beating both the Zacks Consensus Estimate and our model estimates, both of which are pegged at a loss of 2 cents per share. The company recorded adjusted earnings of 3 cents per share in the year-ago quarter.

Revenues, primarily from its cardiovascular drug, Vascepa, were down 37% year over year to approximately $89.9 million in the reported quarter. Quarterly revenues beat the Zacks Consensus Estimate at $89 million but missed our model estimate pegged at $93 million. Sales were hurt due to rising generic competition in the United States and lower net prices in certain countries.

The company continues to avoid revenue guidance for 2022 due to the uncertainty related to the COVID-19 pandemic and generic competition for its sole marketed drug, Vascepa, in the United States, and challenges in achieving market access reimbursement for Vazkepa in Europe.

Following the earnings announcement, shares of Amarin declined 3.39% on Oct 27. The stock has declined 65.5% so far this year compared with the industry’s 23.3% fall.

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Quarter in Details

Product revenues, entirely from Vascepa, were down 37% year over year, at $89.2 million. Although Vascepa sales beat the Zacks Consensus Estimate of $88 million, it missed our model estimates of $92.3 million.

U. S product revenues in the third quarter were $87.9 million due to lower volumes amid rising generic competition for Vascepa’s reduction of triglyceride levels indication. The drug’s sales in the United States beat our model estimate of $85.9 million for the quarter.

The company stated that a new generic version of Vascepa entered the U.S. market during the first quarter, taking the total to three generic versions as of Sep 30, 2022. Vascepa sales were also hurt due to the restructuring initiatives announced by the company in June, which dented the sales and marketing efforts and commercial footprint of Amarin in the United States.

International product revenues were $1.3 million and product revenues in the European market reached $0.7 million.

Licensing and royalty revenues were $0.7 million in the third quarter compared with $0.6 million in the year-ago period.  However, the licensing and royalty revenues missed our estimate of $0.8 million. The royalty revenues were generated from sales of Vascepa recorded by its partners in Canada, China and the Middle East.

The company ended the quarter with $306 million in cash and investments, compared with $324.6 million as of Jun 30, 2022.

In June 2022, Amarin implemented a comprehensive cost and organizational restructuring plan addressing the rising generic competition for Vascepa in the United States. In the third quarter, the company started to witness the benefits of the restructuring program. Amarin continues to expect to reduce its total operational expenditure over the next 12 months by approximately $100 million. This will enable Amarin to maintain a positive contribution margin in the United States while continuing to invest in its imminent European market launches and global expansion.

Amarin also announced initiatives to streamline operating expenditures, including reductions and reallocations in overall selling, general and administrative (SG&A) expenses and research and development (R&D) strategies. The company is using a more focused, stepwise approach for its fixed-dose combination (FDC) program in its pipeline.

Thus, the SG&A expenses in the third quarter were down 43% year over year, at $58.7 million. Moreover, the research and development (R&D) expenses were also down by 26% year over year at $5.8 million. The decline in SG&A and R&D expenses can be attributed to the implementation of the restructuring plan. However, lower SG&A expenses were partially offset by the investments in Europe to support commercial operations.

Vascepa Updates

Amarin launched Vazkepa (U.S. tradename Vascepa) in Germany in September 2021. However, the company has not been able to reach a viable agreement on the reimbursement price of Vazkepa in Germany. Amarin announced a discontinuation of its German operations of Vazkepa in August 2022. As a result, the company incurred a total of $4.4 million in restructuring changes, all of which were cash expenditures incurred during the third quarter of 2022.

In July, Amarin received a final reimbursement decision from the U.K.’s National Institute for Health and Care Excellence (NICE) for Vazkepa in England and Wales. Amarin also received its first reimbursement in Sweden back in March, which followed the individual reimbursement in Denmark achieved in mid-February. Amarin is already on the market and in the commercial launch stage in the U.K. and Sweden.  

Amarin obtained an individual reimbursement for Vazkepa in Austria, with a process underway for national reimbursement. Amarin also received a positive reimbursement assessment from the French National Authority of Health (HAS) and is in the process of price negotiations. The company recently received its final positive national reimbursement in Northern Ireland and Finland at a price in line with U.K. pricing.

Amarin Corporation PLC Price, Consensus and EPS Surprise

 

Amarin Corporation PLC Price, Consensus and EPS Surprise

Amarin Corporation PLC price-consensus-eps-surprise-chart | Amarin Corporation PLC Quote

 

Zacks Rank and Other Stocks to Consider

Amarin currently sports a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks in the same sector are Codiak BioSciences , Eton Pharmaceuticals (ETON - Free Report) and Puma Biotechnology (PBYI - Free Report) , each sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank  stocks here.

Codiak’s loss estimates for 2022 have remained steady at $1.81 in the past 30 days. Shares of Codiak have declined 93.8% year to date. Earnings of CDAK beat earnings estimates in three of the last four quarters, while missing the same in one, witnessing a surprise of 35.40%, on average.

Eton Pharmaceuticals’ loss estimates for 2022 have remained steady at 44 cents in the past 30 days. Shares of ETON have declined 40.1% year to date. Earnings of Eton missed earnings estimates in all of the last four quarters, the negative earnings surprise being 138.48%, on average

Puma Biotechnology’s loss estimates for 2022 have remained steady at 6 cents in the past 30 days. Shares of PBYI have declined 26.7% year to date. Earnings of PBYI beat earnings estimates in three of the trailing four quarters and missed the same in one, with a surprise of 201.37%, on average.


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