8-K
AGIOS PHARMACEUTICALS, INC. (AGIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 12, 2020
Agios Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-36014 | 26-0662915 |
|---|---|---|
| (State or Other Jurisdiction<br> <br>of Incorporation) | (Commission<br> <br>File Number) | (IRS Employer<br> <br>Identification No.) |
| 88 Sidney Street, Cambridge, MA | 02139 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (617) 649-8600
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br> <br>symbol(s) | Name of each exchange<br> <br>on which registered |
|---|---|---|
| Common Stock, Par Value $0.001 per share | AGIO | Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
|---|
Although it has not finalized its full financial results for the fourth quarter and fiscal year ended December 31, 2019, Agios Pharmaceuticals, Inc. (the “Company”) announced on January 12, 2020, that it expects to report that it had approximately $717.8 million of cash, cash equivalents and marketable securities as of December 31, 2019.
The information contained in Item 2.02 of this Form 8-K is unaudited and preliminary, and does not present all information necessary for an understanding of the Company’s financial condition as of December 31, 2019 and its results of operations for the three months and year ended December 31, 2019. The audit of the Company’s consolidated financial statements for the year ended December 31, 2019 is ongoing and could result in changes to the information set forth above.
The information in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
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On January 12, 2020, the Company issued a press release outlining its key 2020 initiatives for its malignant hematology, solid tumors and rare genetic disease programs and its strategic vision for 2025, which will be discussed at the Company’s presentation at the 38th Annual J.P. Morgan Healthcare Conference on January 13, 2020. The full text of the press release issued in connection with this announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Forward Looking Statements
This Current Report on Form 8-K and the exhibits attached hereto contain forward-looking statements of the Company that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K and the exhibits attached hereto, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” “vision” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the Company’s estimates regarding its balance of cash, cash equivalents and marketable securities for the year ended December 31, 2019; the Company’s strategic vision for 2025; its key milestones for 2020; its financial guidance regarding the period in which it will have capital available to fund its operations; and other expectations regarding its business, plans, prospects and strategies. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes due to a number of important factors, including those Risk Factors discussed in the Company’s public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of the date hereof, and the Company 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.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit <br>No. | Description | |
|---|---|---|
| 99.1 | Press release issued January 12, 2020. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AGIOS PHARMACEUTICALS, INC. | ||
|---|---|---|
| Date: January 13, 2020 | By: | /s/ Jacqualyn A. Fouse |
| Jacqualyn A. Fouse, Ph.D.<br> <br>Chief Executive Officer |
EX-99.1
Exhibit 99.1
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 aBroad Research Pipeline –
– Broadening Opportunities for PKR Activation: Topline Data from Pivotal Studies of Mitapivatin 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 Filingfor Cholangiocarcinoma Expected by Year-end 2020 –
– Financial Highlights Include2020 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 38^th^ 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
The “Agios 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:
| • | 4 marketed medicines discovered and developed at Agios |
|---|---|
| • | Approvals in 8+ indications spanning hematologic malignancies, solid tumors and rare genetic diseases<br> |
| --- | --- |
| • | 6+ molecules in the clinic generated by the company’s internal research discovery engine<br> |
|---|---|
| • | Cash-flow positive within the six-year timeframe<br> |
| --- | --- |
ANTICIPATED 2020 KEY MILESTONES
Agios announced today that it expects to achieve the following key milestones in 2020:
Hematologic Malignancies
| • | Deliver full-year U.S. revenue for TIBSOVO^®^ of $105-115 million |
|---|---|
| • | Receive European Medicines Agency CHMP opinion for<br>TIBSOVO^®^ in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by year-end |
| --- | --- |
| • | Complete enrollment of Phase 3 AGILE trial of TIBSOVO^®^<br>in combination with azacitidine in adult patients with previously untreated IDH1 mutant AML by year-end |
| --- | --- |
| • | Complete enrollment of the relapsed or refractory myelodysplastic syndrome arm of the TIBSOVO^®^ Phase 1 study of IDH1 mutant advanced hematologic malignancies by year-end |
| --- | --- |
Solid Tumors
| • | File supplemental new drug application (sNDA) for<br>TIBSOVO^®^ in previously treated IDH1 mutant cholangiocarcinoma by year-end |
|---|
Rare Genetic Diseases
| • | Announce topline data for ACTIVATE and ACTIVATE-T pivotal trials for<br>mitapivat in adults with pyruvate kinase (PK) deficiency by year-end |
|---|---|
| • | Submit updated data from the Phase 2 study of mitapivat in thalassemia for presentation at the European<br>Hematology Association (EHA) Congress and finalize pivotal development strategy by year-end |
| --- | --- |
| • | Achieve proof of concept for mitapivat in sickle cell disease by mid-2020<br> |
| --- | --- |
| • | Receive investigational new drug (IND) clearance for AG-946, a next<br>generation PKR activator, and initiate first-in-human study in healthy volunteers in the first half of 2020 |
| --- | --- |
Research
| • | Achieve at least one new development candidate by year-end<br> |
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RECENT MILESTONES
The company also provided an update on the following 2019 key milestones:
| • | Completed enrollment of ACTIVATE-T, a<br>single-arm trial evaluating mitapivat in regularly transfused adults with PK deficiency |
|---|---|
| • | Expect to complete enrollment in ACTIVATE, a 1:1 randomized, placebo-controlled trial in adult PK deficiency<br>patients who do not receive regular transfusions, in the first quarter of 2020 |
| --- | --- |
| • | Initiated the registration-enabling Phase 3 INDIGO study of vorasidenib in patients with Grade 2 non-enhancing glioma with an IDH mutation |
|---|
2019 Year-EndCash and Guidance
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 38^th^ Annual J.P. Morgan Healthcare Conference
Agios will webcast its corporate presentation and break out session from the 38^th^ 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.
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), 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.
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Contacts
Investors:
Holly Manning, 617-844-6630
Associate Director, Investor Relations
Holly.Manning@agios.com
Media:
Jessica Rennekamp, 857-209-3286
Associate Director, Corporate Communications
Jessica.Rennekamp@agios.com