On April 28, 2021 Alkermes plc (Nasdaq: ALKS) reported financial results for the first quarter of 2021 (Press release, Alkermes, APR 28, 2021, View Source [SID1234578653]).
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"Our first quarter results reflect solid execution against our strategy to grow revenues and actively manage our cost structure. As the country begins to see signs of recovery from the pandemic, we believe we are well-positioned to efficiently manage our business and to achieve our long-term profitability targets," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are reiterating our financial expectations for 2021, as we continue to position VIVITROL and ARISTADA for long-term growth, prepare for the anticipated launch of LYBALVI, advance the clinical development program for nemvaleukin and invest in our neuroscience and oncology development pipeline."
Quarter Ended March 31, 2021 Financial Results
Revenues
Total revenues for the quarter were $251.4 million. This compared to $246.2 million for the same period in the prior year.
Net sales of proprietary products for the quarter were $130.0 million, compared to $129.7 million for the same period in the prior year.
Net sales of VIVITROL were $74.5 million, compared to $78.8 million for the same period in the prior year, representing a decrease of approximately 5%, primarily due to COVID-19-related disruptions.
Net sales of ARISTADAi were $55.4 million, compared to $51.0 million for the same period in the prior year, representing an increase of approximately 9%.
Manufacturing and royalty revenues for the quarter were $119.8 million, compared to $116.3 million for the same period in the prior year.
Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $75.7 million, compared to $82.2 million for the same period in the prior year.
Manufacturing and royalty revenues from VUMERITY were $13.4 million, compared to $1.7 million for the same period in the prior year.
Costs and Expenses
Total operating expenses for the quarter were $267.9 million, compared to $283.6 million for the same period in the prior year.
Cost of Goods Manufactured and Sold were $41.0 million, compared to $47.2 million for the same period in the prior year.
Research and Development (R&D) expenses were $92.3 million, compared to $93.3 million for the same period in the prior year.
Selling, General and Administrative (SG&A) expenses were $125.2 million, compared to $133.4 million for the same period in the prior year.
Profitability
Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $22.4 million for the quarter, or a basic and diluted GAAP loss per share of $0.14. This compared to GAAP net loss of $38.7 million, or a basic and diluted GAAP loss per share of $0.24, for the same period in the prior year.
Non-GAAP net income was $17.8 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.11. This compared to non-GAAP net income of $1.7 million, or a non-GAAP basic and diluted earnings per share of $0.01 for the same period in the prior year.
Balance Sheet
At March 31, 2021, the company recorded cash, cash equivalents and total investments of $627.4 million, compared to $659.8 million at Dec. 31, 2020, driven primarily by the company’s operating results and changes in working capital. The company’s total debt outstanding as of March 31, 2021 was $297.7 million, following the March 2021 refinancing of the company’s term loan, which extended its maturity date to March 2026.
Financial Expectations for 2021
Alkermes reiterates its financial expectations for 2021, and the assumptions underlying such expectations, as set forth in its press release dated Feb. 11, 2021.
"We are intensely focused on increasing Alkermes’ value through the combination of scientific and business excellence. The first few months of 2021 were highlighted by important advancements in our nemvaleukin immuno-oncology program, including receipt of orphan drug designation for mucosal melanoma, initiation of ARTISTRY-6, a phase 2 trial to further evaluate nemvaleukin’s monotherapy utility in melanoma, entry into a clinical trial and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) in platinum-resistant ovarian cancer, and achievement of the first partial response in platinum-resistant ovarian cancer in the ARTISTRY-2 subcutaneous dosing study. At our recent Investor Day, we also introduced new assets from our pipeline, including our CoREST-selective HDAC inhibitor program, our orexin 2 receptor agonist program and our platform of engineered cytokines, including our tumor-targeted, split IL-12 fusion protein," said Richard Pops, Chief Executive Officer of Alkermes. "Coupled with expected growth of our commercial portfolio, including the potential launch of LYBALVI and growth of VUMERITY, and a focus on efficiency, cost management and strong governance, we have the potential to drive significant growth and value creation in 2021 and beyond."
Recent Events:
Nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230)
In March 2021, nemvaleukin, the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, was granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).
In April 2021, the company entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin in combination with KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer. The study is planned to initiate in the second half of 2021.
In April 2021, the company initiated ARTISTRY-6, a global phase 2 study evaluating the anti-tumor activity, safety and tolerability of intravenous nemvaleukin monotherapy in patients with mucosal melanoma. The study also includes a cohort of patients with advanced cutaneous melanoma who will receive subcutaneous (SC) nemvaleukin with intent to establish monotherapy proof-of-concept with SC dosing.
Psychiatry
In April 2021, the company presented new research from its psychiatry portfolio at the 2021 Congress of the Schizophrenia International Research Society (SIRS), which took place virtually April 17-21, 2021. The company’s presentations included new exploratory analyses from its phase 3 ENLIGHTEN-2 study of LYBALVI.
Corporate
In March 2021, Alkermes held a virtual Investor Day to discuss the company’s research and development strategy and portfolio, including updates from its nemvaleukin development program and introduction of new preclinical neuroscience and immuno-oncology programs. The company also provided an update on the implementation of its Value Enhancement Plan announced in December 2020.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 28, 2021, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, April 28, 2021, through Wednesday, May 5, 2021, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13718854.