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– Commercial Organization Launch Ready Ahead of June 21, 2019 PDUFA Action Date for Single Agent TIBSOVO® for IDH1m Newly Diagnosed AML –
– Updated Data from Phase 1 Studies of TIBSOVO ® in Newly Diagnosed AML and First Data from Perioperative Study of TIBSOVO ® and Vorasidenib Accepted for Presentation at ASCO –
– Broad Clinical Development Plan for Mitapivat Progressing with Pyruvate Kinase Deficiency Pivotal Studies Enrolling, First Patient Dosed in Phase 2 Thalassemia Study and NIH-Sponsored Sickle Cell Study to Initiate in 2019 –
– $9.1M First Quarter Net Revenue for TIBSOVO ® ; March 31, 2019 Cash, Cash Equivalents and Marketable Securities was $707.8M; Provides Runway Through at Least the End of 2020 –
CAMBRIDGE, Mass., May 02, 2019 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today reported business highlights and financial results for the first quarter ended March 31, 2019.
“We continued to deliver significant progress across our oncology and rare genetic disease programs during the first quarter. Importantly, our U.S. commercial team is driving TIBSOVO® toward solid performance for its first full year on the market, and we are on track to achieve our internal forecast,” said Jackie Fouse, Ph.D., chief executive officer at Agios. “We made progress on expansion opportunities for TIBSOVO® across the frontline AML setting. FDA accepted our sNDA in newly diagnosed AML, the HOVON/AMLSG Phase 3 intensive chemotherapy combination study initiated, and we received Breakthrough Therapy Designation for the combination of TIBSOVO® and azacitadine. We also advanced our mitapivat program. Our two pivotal trials in pyruvate kinase deficiency remain on track to complete enrollment this year, we have dosed the first patient in our Phase 2 thalassemia study, and we now expect a NIH-sponsored study in sickle cell disease to initiate this year.”
FIRST QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS
KEY UPCOMING MILESTONES
The company plans to achieve the following key milestones in the remainder of 2019:
Rare Genetic Diseases:
ANTICIPATED 2019 DATA PRESENTATIONS
FIRST QUARTER 2019 FINANCIAL RESULTS
Revenue: Total revenue for the first quarter of 2019 was $30.2 million, which includes $17.9 million in collaboration revenue and $2.2 million in royalty revenue from net global sales of IDHIFA® under our collaboration agreement with Celgene, and $9.1 million of net product revenue from U.S. sales of TIBSOVO®. This compares to revenue of $8.8 million for the first quarter of 2018, which included $7.3 million in collaboration revenue and $1.4 million in royalty revenue from net global sales of IDHIFA® under our collaboration agreement with Celgene.
Cost of Sales: We began U.S. sales of TIBSOVO® in the third quarter of 2018. Cost of sales were $0.3 million for the first quarter of 2019.
Research and Development (R&D) Expenses: R&D expenses were $95.6 million for the first quarter of 2019 compared to $78.2 million for the first quarter of 2018. The increase in R&D expense was primarily attributable to clinical trial activity related to TIBSOVO® frontline trials, the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia, and start-up activities for AG-636.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $31.8 million for the first quarter of 2019 compared to $24.6 million for the first quarter of 2018. The increase in SG&A expense was primarily attributable to costs to support commercialization of TIBSOVO® and personnel costs related to increased headcount.
Net Loss: Net loss was $93.1 million for the first quarter of 2019 compared to $90.8 million for the first quarter of 2018.
Cash Position and Guidance: Cash, cash equivalents and marketable securities as of March 31, 2019 were $707.8 million compared to $805.4 million as of December 31, 2018. The net decrease of $97.6 million in cash position was primarily driven by net expenditures to fund operations, including a onetime cash expense of $19.2 million for bonus payouts during the first quarter. The company expects that its cash, cash equivalents and marketable securities as of March 31, 2019, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.
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 2019 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 referring to conference ID 9573049. 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 cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism and adjacent areas of biology. In addition to an active research and discovery pipeline across both therapeutic areas, Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics. For more information, please visit the company's website at www.agios.com.
About Agios/Celgene Collaboration
IDHIFA® (enasidenib) and AG-270 are part of our collaboration with Celgene Corporation. Under the terms of our 2010 collaboration agreement focused on cancer metabolism, Celgene has worldwide development and commercialization rights for IDHIFA®. Agios continues to conduct certain clinical development activities within the IDHIFA® development program and is eligible to receive reimbursement for those development activities and up to $80 million in remaining milestone payments, and royalties on any net sales. Celgene and Agios are currently co-commercializing IDHIFA® in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts. AG-270 is part of a 2016 global research collaboration agreement with Celgene focused on metabolic immuno-oncology. Celgene has the option to participate in a worldwide 50/50 cost and profit share with Agios, under which Agios is eligible for up to $169 million in clinical and regulatory milestone payments for the program.
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 its and its collaborator’s preclinical, clinical and commercial advancement of its drug development programs including TIBSOVO® (ivosidenib), IDHIFA® (enasidenib), vorasidenib, mitapivat, AG-270 and AG-636; the potential benefits of Agios' product candidates; its key milestones for 2019; its plans regarding future data presentations; its financial guidance regarding the period in which it will have capital available to fund its operations; and the potential benefit of its strategic plans and focus. The words “anticipate,” “expect,” “hope,” “milestone,” “plan,” “potential,” “possible,” “strategy,” “will,” 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. For example, there can be no guarantee that any product candidate Agios or its collaborators is developing will successfully commence or complete necessary preclinical and clinical development phases, or that development of any of Agios' product candidates will successfully continue. There can be no guarantee that any positive developments in Agios' business will result in stock price appreciation. 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: 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 regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios' ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios' ability to maintain key collaborations, such as its agreements with Celgene and CStone Pharmaceuticals; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in Agios’ public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and marketable securities||$||707,791||$||805,421|
|Accounts receivable, net||4,355||5,076|
|Collaboration receivable – related party||2,319||2,462|
|Royalty receivable – related party||2,200||2,234|
|Deferred revenue – related party||77,128||92,519|
Condensed Consolidated Statements of Operations Data
(in thousands, except share and per share data)
|Three Months Ended March 31,|
|Product revenue, net||$||9,138||$||-|
|Collaboration revenue – related party||17,919||7,345|
|Collaboration revenue – other||970||-|
|Royalty revenue – related party||2,200||1,417|
|Cost and expenses:|
|Cost of sales||334||-|
|Research and development, net||95,585||78,224|
|Selling, general and administrative||31,791||24,550|
|Total cost and expenses||127,710||102,774|
|Loss from operations||(97,483)||(94,012)|
|Net loss per share – basic and diluted||$||(1.59)||$||(1.63)|
|Weighted-average number of common shares used in computing net loss per share – basic and diluted||58,453,918||55,694,603|
Investor & Media Contact:
Holly Manning, 617-844-6630
Associate Director, Investor Relations