Agios Reports Business Highlights and First Quarter 2021 Financial Results
– Data from ACTIVATE and ACTIVATE-T Phase 3 Studies of Mitapivat in Pyruvate Kinase (PK) Deficiency and Phase 2 Study of Mitapivat in Thalassemia Accepted for Presentation at EHA 2021
– Company Expects to File for Regulatory Approval for Mitapivat for the Treatment of Adults with PK Deficiency in the
– Sale of Oncology Portfolio to Servier Closed on
“With the recent closing of the sale of our oncology business, we are excited to embrace a focused future in genetically defined diseases,” said
FIRST QUARTER 2021 & RECENT HIGHLIGHTS
- Closed the sale of commercial, clinical and research-stage oncology portfolio to
Servier Pharmaceuticals, LLC, on March 31, 2021.
- Initiated the repurchase of up to
$1.2 billionof outstanding shares, as authorized by the board of directors, and entered into a definitive agreement with Bristol-Myers Squibb Company (BMS) to repurchase 7,121,658 shares of Agios common stock held by BMS and its affiliates for an aggregate purchase price of $344.5 million, or $48.38per share. Agios expects to execute a meaningful portion of the planned repurchases by year-end through a combination of 10b5-1 plans and open market purchases.
- Supported several educational and patient-focused initiatives, including the sponsorship of a health literacy program for sickle cell disease and the launch of a collaboration with 23andMe that led to addition of the very first PK deficiency carrier status report.
KEY UPCOMING MILESTONES
- Finalize global regulatory filings for mitapivat in adults with PK deficiency; submit new drug application (NDA) in the
U.S.in the second quarter of 2021 and marketing authorization application (MAA) in the EU in mid-2021.
- Initiate two Phase 3 studies of mitapivat, ENERGIZE and ENERGIZE-T, in not regularly transfused and regularly transfused adults with thalassemia in the second half of 2021.
- Initiate Phase 2/3 study of mitapivat in sickle cell disease by year-end.
- Prioritize new indications for pyruvate kinase R (PKR) and pyruvate kinase M2 (PKM2) activator clinical development by year-end.
- Present data from the following clinical studies for presentation at the EHA Virtual Congress, hosted June 9-17, 2021:
- Phase 3 ACTIVATE study of mitapivat in adults with PK deficiency who do not receive regular transfusions
- Phase 3 ACTIVATE-T study of mitapivat in adults with PK deficiency who receive regular transfusions
- Phase 2 study of mitapivat in adults with α- and β-thalassemia who do not receive regular transfusions
- Submit data from ongoing clinical studies of mitapivat in sickle cell disease for presentation at medical meetings in 2021.
- Present data from the Phase 1 study of AG-946, the company's next-generation PKR activator, in healthy volunteers by year-end.
FIRST QUARTER 2021 FINANCIAL RESULTS
Research and Development (R&D) Expenses: R&D expenses for continuing operations were $57.7 million for the first quarter of 2021 compared to $55.4 million for the first quarter of 2020. The year-over-year increase in R&D was driven primarily by start-up costs associated with the Phase 3 studies of mitapivat in thalassemia and sickle cell disease.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for continuing operations were $33.6 million for the first quarter of 2021 compared to $31.7 million for the first quarter of 2020. The year-over-year increase in SG&A expenses was primarily attributable to one-time workforce expense.
Discontinued Operations: Due to the sale of the oncology business during the first quarter of 2021, we have reclassified the results of the oncology business as discontinued operations, including total revenue of
Net Income: Net income was $1.9 billion for the first quarter of 2021 compared to a net loss of $40.3 million for the first quarter of 2020.
Cash Position and Guidance: Cash, cash equivalents and marketable securities as of March 31, 2021 were $2.4 billion compared to $613.1 million as of March 31, 2020. The company expects that its cash, cash equivalents and marketable securities as of
CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss first quarter 2021 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 4497151. The live webcast can be accessed under “Events & Presentations” in the Investors section of the company's website at www.agios.com. The archived webcast will be available on the company's website beginning approximately two hours after the event.
Agios is focused on discovering and developing novel investigational medicines to treat genetically defined diseases through scientific leadership in the field of cellular metabolism. The company’s most advanced drug candidate is a first-in-class pyruvate kinase R (PKR) activator, mitapivat, that is currently being evaluated for the treatment of three distinct hemolytic anemias. In addition to its active late-stage clinical pipeline, Agios has multiple novel, investigational therapies in clinical and preclinical development. For more information, please visit the company’s website at www.agios.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Agios’ plans, strategies and expectations for the preclinical, clinical and commercial advancement of its drug development programs, including mitapivat; the potential benefits of Agios’ products and product candidates; Agios’ key milestones and guidance for 2021; its financial guidance regarding the period in which it will have capital available to fund its operations; expectations regarding the return of capital to shareholders following the sale of Agios’ oncology business; and the potential benefits of Agios’ strategic plans and focus. The words “anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,” “potential,” “possible,” “strategy,” “will,” “vision,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including, without limitation risks and uncertainties related to: the failure of Agios to receive milestone or royalty payments related to the sale of its oncology business, the uncertainty of the timing of any receipt of any such payments, and the uncertainty of the results and effectiveness of the use of proceeds from the transaction; the impact of the COVID-19 pandemic to Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of future approved products, and launching, marketing and selling future approved products; Agios’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the
Senior Director, Investor Relations
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and marketable securities||$||2,357,201||$||670,537|
|Assets held for discontinued operations||-||50,460|
|Liabilities held for discontinued operations||-||299,728|
|Consolidated Statements of Operations Data|
|(in thousands, except share and per share data)|
|Cost and expenses:|
|Research and development||$||57,667||$||55,358|
|Selling, general and administrative||$||33,550||$||31,672|
|Total cost and expenses||$||91,217||$||87,030|
|Loss from operations||$||(91,217||)||$||(87,030||)|
|Interest income, net||$||340||$||2,936|
|Net loss from continuing operations||$||(90,877||)||$||(84,094||)|
|Net income from discontinued operations, net of tax||$||1,965,202||$||43,838|
|Net Income (loss)||$||1,874,325||$||(40,256||)|
|Net (loss) from continuing operations per share - basic and diluted||$||(1.31||)||$||(1.23||)|
|Net income from discontinued operations per share - basic and diluted||$||28.26||$||0.64|
|Net income (loss) per share - basic and diluted||$||26.95||$||(0.59||)|
|Weighted-average number of common shares used in computing net income (loss) per share – basic and diluted||69,543,510||68,608,279|
Source: Agios Pharmaceuticals, Inc.