AGIO Agios Pharmaceuticals Inc.

40.55
-0.53  -1%
Previous Close 41.08
Open 41.03
52 Week Low 27.774
52 Week High 56.745
Market Cap $2,802,413,906
Shares 69,110,084
Float 44,627,535
Enterprise Value $2,104,354,385
Volume 432,982
Av. Daily Volume 638,390
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Upcoming Catalysts

Drug Stage Catalyst Date
AG-120 Ivosidenib (ClarIDHy)
IDH1 mutant positive cholangiocarcinoma - cancer
Phase 3
Phase 3
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AG-348 - Mitapivat (ASH)
Sickle cell disease.
Phase 2
Phase 2
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AG-348 (ACTIVATE-T)
Pyruvate kinase deficiency
Phase 3
Phase 3
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AG-348 - Mitapivat (ACTIVATE)
Pyruvate Kinase Deficiency
Phase 3
Phase 3
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AG-270
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
AG-946
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial to commence 3Q 2020.
Enasidenib (AG-221) - IDHENTIFY
Refractory Acute myeloid leukemia (AML) - cancer
Phase 3
Phase 3
Global Phase 3 study for AG-221 initiated October 2015. Continues to enroll as of January 2018.
AG-348 - Mitapivat
Thalassemia
Phase 2
Phase 2
Phase 2 updated data at EHA June 12, 2020. Primary endpoint defined as a ≥1.0 g/dL increase in Hb concentration from baseline at 1 or more assessments between week 4 and week 12 was met by 12 of 13 (92.3%) patients.
Vorasidenib (AG-881)
IDHm low-grade glioma
Phase 1
Phase 1
Phase 1 presentation at ASCO May 29, 2020. Median Progression-free Survival of 31.4 months.
AG-120 and VIDAZA - AGILE
Frontline Acute myeloid leukemia (AML) harboring an IDH1 mutation - cancer
Phase 3
Phase 3
Phase 3 enrolment to be completed 2021.
Vorasidenib (AG-881)
Glioma
Phase 3
Phase 3
Phase 3 enrolment has slowed as a result of COVID-19.
Ivosidenib and azacitidine ( Vidaza)
Newly diagnosed AML with an IDH1 mutation
Phase 1
Phase 1
Phase 1 updated data at ASH December 9, 2019 noted complete response (CR) rate of 61% and a CR + CR with partial hematologic recovery (CRh) rate of 70%.
Enasidenib or ivosidenib with VIDAZA
Frontline AML with IDH1 or IDH2 mutation
Phase 1/2
Phase 1/2
Phase 1 updated data February 25, 2019 noted ORR of 78%, 57% CR rate, and 12-month Survival Rate of 82%.
Ivosidenib
IDH1 mutant newly diagnosed AML ineligible for standard therapies
Phase 1
Phase 1
Phase 1 updated data at ASCO June 3, 2019. 30% CR rate.
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
Approved
Approved
Approval announced August 1, 2017.
Ivosidenib
Frontline AML with IDH1 mutation
Approved
Approved
FDA Approval announced May 2, 2019.
Ivosidenib
IDH1m Relapsed/Refractory AML - cancer
Approved
Approved
FDA Approval announced July 20, 2018.

Latest News

  1. CAMBRIDGE, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the company is scheduled to present at the virtual Canaccord 40th Annual Growth Conference on Thursday, August 13, 2020 at 1:00 p.m. ET.

    A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

    About Agios
    Agios is focused on discovering and developing novel investigational medicines to treat malignant hematology, solid tumors and rare…

    CAMBRIDGE, Mass., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the company is scheduled to present at the virtual Canaccord 40th Annual Growth Conference on Thursday, August 13, 2020 at 1:00 p.m. ET.

    A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

    About Agios

    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.

    Contacts

    Investors:

    Holly Manning, 617-844-6630

    Director, Investor Relations

    Media:

    Jessica Rennekamp, 857-209-3286

    Associate Director, Corporate Communications

    Primary Logo

    View Full Article Hide Full Article
  2. – Second Quarter TIBSOVO® Net Revenue of $27.6 Million; Company Reiterates 2020 TIBSOVO® Net U.S. Revenue Guidance of $105–115 Million –

    – Significant Clinical Progress for First-in-Class PKR Activator Mitapivat: Established Proof-of-Concept in Sickle Cell Disease; Presented Phase 2 Data in α- and β-Thalassemia; Pivotal Programs to be Initiated in 2021 –

    – $255 Million Sale of IDHIFA® Royalty Extends Cash Runway, Inclusive of Thalassemia and Sickle Cell Disease Pivotal Development, through the End of 2022 –

    CAMBRIDGE, Mass., July 30, 2020 (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…

    – Second Quarter TIBSOVO® Net Revenue of $27.6 Million; Company Reiterates 2020 TIBSOVO® Net U.S. Revenue Guidance of $105–115 Million –

    – Significant Clinical Progress for First-in-Class PKR Activator Mitapivat: Established Proof-of-Concept in Sickle Cell Disease; Presented Phase 2 Data in α- and β-Thalassemia; Pivotal Programs to be Initiated in 2021 –

    – $255 Million Sale of IDHIFA® Royalty Extends Cash Runway, Inclusive of Thalassemia and Sickle Cell Disease Pivotal Development, through the End of 2022 –

    CAMBRIDGE, Mass., July 30, 2020 (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 second quarter ended June 30, 2020.

    "The second quarter was a productive and important time at Agios, as we accomplished several key 2020 objectives across our three focus areas of malignant hematology, solid tumors and rare genetic diseases. In particular, we made significant progress on our mitapivat clinical programs, including achieving proof-of-concept in sickle cell disease and planning for our pivotal development programs in both thalassemia and sickle cell disease," said Jackie Fouse, Ph.D., chief executive officer at Agios. "For the remainder of 2020, we are focused on the completion of our pivotal trials ACTIVATE and ACTIVATE-T for mitapivat in pyruvate kinase deficiency and securing regulatory feedback on the pivotal programs in both thalassemia and sickle cell disease to enable their initiation next year, the submission of a supplemental new drug application for TIBSOVO® in cholangiocarcinoma in the first quarter of 2021, driving enrollment in our ongoing clinical trials and continued strong commercial execution."

    SECOND QUARTER 2020 HIGHLIGHTS

    Rare Genetic Diseases

    • Established clinical proof-of-concept for mitapivat in sickle cell disease based on a preliminary analysis of data on eight patients from the Phase 1 study being conducted in collaboration with the National Institutes of Health (NIH). Seven of eight (88%) evaluable patients experienced a hemoglobin increase, with five of eight patients (63%) achieving a hemoglobin increase of ≥1.0 g/dL from baseline. Additionally, the data showed improvements in associated markers of sickling as well as a safety profile consistent with previously reported mitapivat data or expected in the context of sickle cell disease.
    • Presented data on 13 patients from the Phase 2 study of mitapivat in non-transfusion-dependent α- and β-thalassemia at the European Hematology Association (EHA) Annual Congress in June. Treatment with mitapivat induced a hemoglobin increase of ≥1.0 g/dL in 12 of 13 (92%) evaluable patients, including four of four (100%) α-thalassemia patients. Additionally, the data showed improvements in associated markers of hemolysis and erythropoiesis as well as a safety profile consistent with previously reported mitapivat data.
    • Received Orphan Drug Designation from the Food and Drug Administration (FDA) for mitapivat in thalassemia.

    Hematologic Malignancies and Solid Tumors

    • TIBSOVO® net sales of $27.6 million, an increase of 22% from the first quarter of 2020; expanded total number of unique prescribers by 15% from the first quarter of 2020.
    • Published data from the Phase 3 ClarIDHy study of TIBSOVO® in The Lancet Oncology. As a result of this publication, the National Comprehensive Cancer Network (NCCN) guidelines were updated to recommend treatment with TIBSOVO® for patients with advanced IDH1-mutant cholangiocarcinoma.
    • Presented updated data from the Phase 1 dose-escalation study of vorasidenib in IDH-mutant non-enhancing glioma at the American Society of Clinical Oncology (ASCO) Annual Meeting in May. In the study, vorasidenib demonstrated prolonged disease control and encouraging preliminary activity, as well as a favorable safety profile consistent with previously reported data.

    Corporate

    • Completed a $255 million purchase agreement with Royalty Pharma for IDHIFA® (enasidenib) royalty rights and outstanding regulatory milestone payments.

    KEY UPCOMING MILESTONES

    Rare Genetic Diseases

    • Report data from ACTIVATE and ACTIVATE-T, the company's two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency, between the end of 2020 and mid-2021.
    • Finalize robust pivotal development plan for mitapivat in thalassemia, including both α-and β-thalassemia, as well as transfusion dependent and non-transfusion dependent patient populations, by the end of 2020.
    • Initiate first-in-human study in healthy volunteers for AG-946, a next-generation PKR activator, in Q3 2020.

    Hematologic Malignancies and Solid Tumors

    • Deliver full-year 2020 U.S. revenue for TIBSOVO® of $105-115 million.
    • Receive European Medicines Agency CHMP opinion for TIBSOVO® in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by the end of 2020.
    • Report mature overall survival data from ClarIDHy Phase 3 study in Q3 2020; if data are supportive, file supplemental new drug application (sNDA) for TIBSOVO® in previously treated IDH1-mutant cholangiocarcinoma in Q1 2021.

    Research

    • Achieve at least one new development candidate by year-end 2020.

    SECOND QUARTER 2020 FINANCIAL RESULTS

    Revenue: Total revenue for the second quarter of 2020 was $37.3 million, which includes $27.6 million of net product revenue from sales of TIBSOVO®, $6.4 million in collaboration revenue and $3.3 million in royalty revenue from net global sales of IDHIFA® under our collaboration agreement with Celgene, now a wholly owned subsidiary of Bristol Myers Squibb. This compares to revenue of $26.2 million for the second quarter of 2019. TIBSOVO® net product revenue increased 101% from the same period last year.

    Cost of Sales: Cost of sales were $0.7 million for the second quarter of 2020 compared to $0.3 million for the second quarter of 2019.

    Research and Development (R&D) Expenses: R&D expenses were $90.9 million for the second quarter of 2020 compared to $107.4 million for the second quarter of 2019. The decrease in R&D expense was primarily attributable to milestone payments related to AG-636 and an undisclosed early-stage research program in the second quarter of 2019, winding down the ClarIDHy Phase 3 study of TIBSOVO® and HOVON startup expenses incurred in the second quarter of 2019, and lower spend across ongoing TIBSOVO® clinical studies as a result of slowed enrollment and reduced activities due to the COVID-19 pandemic.

    Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $36.0 million for the second quarter of 2020 compared to $32.4 million for the second quarter of 2019. The increase in SG&A expense was primarily attributable to the initial gated infrastructure build of the company's European operations offset by reduced travel and industry engagement given restrictions in place to combat the COVID-19 pandemic.

    Net Loss: Net loss was $90.5 million for the second quarter of 2020 compared to $109.9 million for the second quarter of 2019.

    Cash Position and Guidance: Cash, cash equivalents and marketable securities as of June 30, 2020 were $794 million, including the amount received under the Royalty Pharma agreement, compared to $624 million as of June 30, 2019. The company expects that its cash, cash equivalents and marketable securities as of June 30, 2020, together with anticipated product 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, including its pivotal development programs for mitapivat in thalassemia and sickle cell disease, through the end of 2022.

    CONFERENCE CALL INFORMATION

    Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss its second quarter 2020 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 2955575. 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.

    About the Agios/Celgene Collaboration

    In 2010, Agios and Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, entered into a collaboration agreement focused on cancer metabolism. Under the terms of the agreement, Celgene has worldwide development and commercialization rights for IDHIFA® (enasidenib). Celgene and Agios are currently co-commercializing IDHIFA® in the U.S., and Agios continues to conduct certain clinical development activities within the IDHIFA® development program. Agios is eligible to receive a $25 million payment upon achievement of a specified ex-U.S. commercial milestone event, as well as reimbursement for costs incurred for its co-commercialization efforts and development activities.

    About Agios

    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 tablets), IDHIFA® (enasidenib), mitapivat, vorasidenib, AG-270, and AG-946; the potential benefits of Agios' product candidates; its key milestones and guidance for 2020; 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 benefits 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, without limitation: risks and uncertainties related to 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 current or future approved products, and launching, marketing and selling current or 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 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.

     
    Consolidated Balance Sheet Data
    (in thousands)
    (Unaudited)
     June 30, 2020 December 31, 2019
    Cash, cash equivalents, and marketable securities$794,413  $717,806 
    Accounts receivable, net 12,023   8,952 
    Collaboration receivable – related party 2,537   1,539 
    Royalty receivable – related party 1,650   2,900 
    Inventory 11,231   7,331 
    Total assets 976,141   890,741 
    Deferred revenue – related party    61,513 
    Stockholders' equity 558,465   640,528 
            



    Consolidated Statements of Operations Data
    (in thousands, except share and per share data)
    (Unaudited)
     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Product revenue, net$27,581  $13,727  $50,255  $22,865 
    Collaboration revenue – related party 5,735   8,979   65,832   26,898 
    Collaboration revenue – other692  812  1,685   1,782 
    Royalty revenue – related party3,339  2,703  6,673   4,903 
    Total revenue37,347  26,221  124,445   56,448 
    Cost and expenses:       
    Cost of sales675  303  1,208   637 
    Research and development90,917  107,389  182,173   202,974 
    Selling, general and administrative35,951  32,390  74,452   64,181 
    Total cost and expenses127,543  140,082  257,833   267,792 
    Loss from operations(90,196) (113,861) (133,388)  (211,344)
    Interest income, net1,769  3,990  4,705   8,395 
    Non-cash interest expense for the sale of future revenue(2,051)   (2,051)   
    Net loss$(90,478) $(109,871) $(130,734) $(202,949)
    Net loss per share – basic and diluted$(1.31) $(1.87) $(1.90) $(3.46)
    Weighted-average number of common shares used in computing net loss per share – basic and diluted68,958,091  58,722,244  68,784,109   58,589,167 
                 

    Contacts

    Investors:

    Holly Manning, 617-844-6630

    Director, Investor Relations

    Media:

    Jessica Rennekamp, 857-209-3286

    Associate Director, Corporate Communications

    Primary Logo

    View Full Article Hide Full Article
  3. CAMBRIDGE, Mass., July 16, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the company will host a conference call and live webcast on Thursday, July 30, 2020 at 8:00 a.m. ET to report its second quarter 2020 financial results and other business highlights.

    A live webcast can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 2955575. The webcast will be archived and made available for replay on the company's website…

    CAMBRIDGE, Mass., July 16, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the company will host a conference call and live webcast on Thursday, July 30, 2020 at 8:00 a.m. ET to report its second quarter 2020 financial results and other business highlights.

    A live webcast can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 2955575. The webcast will be archived and made available for replay on the company's website beginning approximately two hours after the event.

    About Agios

    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.

    Contacts

    Investors:

    Holly Manning, 617-844-6630

    Director, Investor Relations

    Media:

    Jessica Rennekamp, 857-209-3286

    Associate Director, Corporate Communications

    Primary Logo

    View Full Article Hide Full Article
  4. CAMBRIDGE, Mass., June 17, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the company is scheduled to present at the BMO 2020 Prescriptions for Success Healthcare Virtual Conference on Tuesday, June 23, 2020 at 9:00 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 www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

    About Agios
    Agios is focused on discovering and developing novel investigational medicines to treat malignant hematology, solid tumors…

    CAMBRIDGE, Mass., June 17, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the company is scheduled to present at the BMO 2020 Prescriptions for Success Healthcare Virtual Conference on Tuesday, June 23, 2020 at 9:00 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 www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

    About Agios

    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.

    Contacts

    Investors:

    Holly Manning, 617-844-6630

    Director, Investor Relations

    Media:

    Jessica Rennekamp, 857-209-3286

    Associate Director, Corporate Communications

    Primary Logo

    View Full Article Hide Full Article
  5. – Royalty Pharma Acquires Rights to Agios' Royalty on IDHIFA® Worldwide Net Sales and Outstanding Regulatory Milestone Payments –

    CAMBRIDGE, Mass. and NEW YORK, June 12, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, and Royalty Pharma today announced that Agios has sold its tiered, sales-based royalty rights on worldwide net sales of Bristol Myers Squibb's IDHIFA® (enasidenib), as well as its rights to receive up to $55 million in outstanding regulatory milestone payments from Bristol Myers Squibb, to Royalty Pharma for $255 million. Agios will continue to co-promote IDHIFA® and receive reimbursement from Bristol Myers Squibb for…

    – Royalty Pharma Acquires Rights to Agios' Royalty on IDHIFA® Worldwide Net Sales and Outstanding Regulatory Milestone Payments –

    CAMBRIDGE, Mass. and NEW YORK, June 12, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, and Royalty Pharma today announced that Agios has sold its tiered, sales-based royalty rights on worldwide net sales of Bristol Myers Squibb's IDHIFA® (enasidenib), as well as its rights to receive up to $55 million in outstanding regulatory milestone payments from Bristol Myers Squibb, to Royalty Pharma for $255 million. Agios will continue to co-promote IDHIFA® and receive reimbursement from Bristol Myers Squibb for this co-promotion under its 2010 collaboration agreement with Celgene, a wholly owned subsidiary of Bristol Myers Squibb. Agios also retains the right to receive a $25 million payment upon achievement of a specified ex-U.S. commercial milestone event. IDHIFA® is an oral, targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

    "It is an exciting time at Agios with multiple ongoing mid- and late-stage trials in each of our core therapeutic focus areas that we believe have the potential to make a meaningful difference in patients' lives. This non-dilutive funding provides us with additional financial flexibility as we continue to invest in advancing our robust clinical pipeline, including mitapivat across three rare disease indications and our IDH inhibitors in solid tumors and novel combination approaches for AML," said Jackie Fouse, Ph.D., chief executive officer of Agios. "Royalty Pharma, a pioneer in this space, is an industry leader in identifying promising late-stage and commercial therapies, and we are pleased with their recognition of IDH inhibition as an important therapeutic approach for hematologic malignancies."

    "IDHIFA® is an innovative, targeted treatment that has benefited numerous AML patients who may otherwise have had few other treatment options," said Pablo Legorreta, founder and chief executive officer of Royalty Pharma. "We are delighted to partner with Agios, a biotechnology company that stands out for its strong scientific foundation and a track record of successful development of multiple innovative targeted therapies. The proceeds that Agios will receive today will help further their mission and fund their exciting pipeline that will drive the next phase of the company's growth."

    Cowen served as financing advisor to Agios and Wilmer Hale served as legal advisor to Agios. Goodwin Procter LLP, Dechert LLP and Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbH acted as legal advisors to Royalty Pharma on the transaction.

    About the Agios/Celgene IDH Program

    In 2010, Agios and Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, entered into a collaboration agreement focused on cancer metabolism. Under the terms of the agreement, Celgene has worldwide development and commercialization rights for IDHIFA® (enasidenib). Celgene and Agios are currently co-commercializing IDHIFA® in the U.S., and Agios continues to conduct certain clinical development activities within the IDHIFA® development program. Agios is eligible to receive a $25 million payment upon achievement of a specified ex-U.S. commercial milestone event, as well as reimbursement for costs incurred for its co-commercialization efforts and development activities.

    About Agios

    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.

    About Royalty Pharma

    Founded in 1996, Royalty Pharma is the industry leader in acquiring pharmaceutical royalties. Royalty Pharma funds innovation in life sciences both directly and indirectly: directly when it partners with life sciences companies to co-develop and co-fund products in late-stage clinical trials, and indirectly when it acquires existing royalty interests from the original innovators (academic institutions, research hospitals, foundations and inventors). The company's portfolio includes royalty interests in over 45 products including AbbVie and J&J's Imbruvica, Astellas and Pfizer's Xtandi, Biogen's Tysabri, Gilead's HIV franchise, Merck's Januvia, Novartis' Promacta, and Vertex's Kalydeco, Symdeko and Trikafta. Royalty Pharma is also a leading investor in pre-approval royalties, having since 2012 invested over $6.1 billion in royalties on development-stage product candidates. For more information, visit www.royaltypharma.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' use of proceeds from the transaction with Royalty Pharma, developments regarding Agios' collaboration agreement with Celgene and Agios' strategic plans and prospects. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" 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, without limitation: risks and uncertainties related to 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 current or future approved products, and launching, marketing and selling current or 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 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.

    Agios Contacts

    Investors:

    Holly Manning, 617-844-6630

    Director, Investor Relations



    Media:

    Jessica Rennekamp, 857-209-3286

    Associate Director, Corporate Communications



    Royalty Pharma Contact

    Media and Investor Inquiries:

    212-883-0200

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