Full Press Release Details
Agios Announces Agios 2025 Strategic Vision and Highlights 2020 Milestones
In 2025, Company Expects to Have 4 Marketed Products in at Least 8 Indications, at Least 6 Molecules in Clinical Development and a
Broad Research Pipeline
Broadening Opportunities for PKR Activation: Topline Data from Pivotal Studies of Mitapivat
in PK Deficiency Expected by Year-end 2020 and Clinical Data for PKR Activation in Thalassemia and Sickle Cell Disease Expected Mid-Year 2020
Expanding Utility of IDH Inhibition: Registration-enabling Phase 1 Expansion Underway for TIBSOVO in MDS; Phase 3 INDIGO Study of Vorasidenib in Low-Grade Glioma Enrolling; TIBSOVO sNDA Filing
for Cholangiocarcinoma Expected by Year-end 2020
Financial Highlights Include
2020 TIBSOVO Net U.S. Revenue Guidance of $105 115 Million and Cash Runway Through at Least the End of 2021
SAN FRANCISCO, January 12, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today announced its Agios 2025 six-year strategic vision focused on creating and commercializing differentiated medicines to treat hematologic malignancies, solid tumors and rare genetic diseases. Under this plan, by the end of 2025, the company
expects to have four marketed products across at least eight indications, at least six molecules in clinical development and be cash-flow positive. Agios will present at the 38th Annual J.P.
Morgan Healthcare Conference in San Francisco on Monday, January 13 at 7:30 a.m. PT (10:30 a.m. ET), and a live webcast will be available at investor.agios.com.
We are entering an exciting new chapter for Agios as we advance our first rare genetic disease program across three opportunities in PK deficiency,
thalassemia and sickle cell disease and continue our work to expand the benefit of IDH inhibitors to solid tumors as well as to additional indications in hematologic malignancies, said Jackie Fouse, Ph.D., chief executive officer of Agios.
We will realize our 2025 vision by continuing to leverage our unmatched expertise in cellular metabolism, early translational research and our passionately patient-focused team, the same attributes that enabled us to discover, develop and
market two targeted oncology medications in just 10 years. With both near- and long-term value drivers, Agios enters 2020 with strong momentum that will continue as we work toward achieving our 2025 strategic vision.
AGIOS 2025 STRATEGIC VISION
2025 strategic vision delineates the company s view for growth over the next six years with established and expanding franchises focused on treating hematologic malignancies, solid tumors and rare genetic diseases. As part of this vision,
Agios expects to achieve the following milestones by the end of 2025:
ANTICIPATED 2020 KEY MILESTONES
Agios announced today that it expects to achieve the following key milestones in 2020:
Hematologic Malignancies
Rare Genetic Diseases
also provided an update on the following 2019 key milestones:
Agios ended 2019 with approximately $718 million of cash, cash equivalents and marketable securities. The company expects that
its cash, cash equivalents and marketable securities as of December 31, 2019, together with anticipated product and royalty revenue, interest income and expense reimbursements under our collaboration agreements, but excluding any additional
program-specific milestone payments, will enable the company to fund its planned operating expenses and capital expenditure requirements through at least the end of 2021.
Presentation at 38th Annual J.P. Morgan Healthcare Conference
Agios will webcast its corporate presentation and break out session from the 38th Annual J.P. Morgan
Healthcare Conference in San Francisco on Monday, January 13, 2020 at 7:30 a.m. PT (10:30 a.m. ET). A live webcast of the presentation can be accessed under Events & Presentations in the Investors section of the
company s website at agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.
Agios is focused on discovering and
developing novel investigational medicines to treat malignant hematology, solid tumors and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across these
three therapeutic areas, Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or 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 its and its collaborator s preclinical, clinical and commercial advancement of its drug development programs including TIBSOVO (ivosidenib), IDHIFA (enasidenib), mitapivat, vorasidenib, AG-270 and AG-636; the potential benefits of Agios product candidates; Agios s strategic vision and goals for 2025; its key milestones for 2020; its estimates regarding its balance of cash, cash equivalents and
marketable securities for the year ended December 31, 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, 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. 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 the U.S. FDA, the EMA or other
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; 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.
Holly Manning, 617-844-6630
Associate Director, Investor Relations
Jessica Rennekamp, 857-209-3286
Associate Director, Corporate Communications