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US-Based Biopharma 'In Full Reset Mode,' Analyst Says
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An H.C. Wainwright & Co. report notes that Agios Pharmaceuticals "is rapidly rebooting and has made critical progress on various fronts."

In a July 30 research note, H.C. Wainwright & Co. analyst Michael King reported the highlights of Agios Pharmaceuticals Inc.'s (AGIO:NASDAQ) Q2/21, as it continued transforming into a rare-disease company.

Agios is advancing mitapivat in pyruvate kinase deficiency, thalassemia and sickle cell disease and pushing forward on its earlier research and development (R&D) pipeline.

"The company is rapidly rebooting and has made critical progress on various fronts," King noted.

During Q2/21, Agios filed a new drug application with the U.S. Food & Drug Administration and the European Medicines Agency.

The biopharma announced and presented Phase 3 data from its ACTIVATE and ACTIVATE-T clinical trials of mitapivat in pyruvate kinase deficiency at the annual European Hematology Association (EHA) meeting. The biopharma also presented the safety and efficacy data of mitapivat in thalassemia, which were positive, at the EHA meeting.

Agios also launched two programs, a share repurchase program of $1.2 billion and myAgios, a patient support service that aims to more efficiently identify patients who qualify for any of its clinical trials, thereby ensuring more expedient enrollment.

As for Agios' Q2/21 financials, King noted the biopharma posted a net loss of $86.2 million, in line with H.C. Wainwright's estimated $86.3 million. Spending, however, was modestly higher than expected in terms of R&D expense as well as selling, general and administrative (SG&A) expense. On R&D, Agios spent $62.0 million, higher than H.C. Wainwright's projection of $55.7 million. For SG&A costs, Agios paid $31.4 million versus H.C. Wainwright's forecast of $29.2 million.

H.C. Wainwright does not view Agios "as an earnings-driven story; rather it is based on the commercial and clinical advancement of mitapivat for the treatment of hemoglobinopathies," King commented.

After adjusting its model on Agios based on the new data, H.C. Wainwright reiterated its Buy rating but increased its target price on the biopharma to $93 per share, from $88. In comparison, Agios is currently trading at about $46.40 per share.

Three catalysts are on the horizon for this Massachusetts-based biopharma: starting the ENERGIZE and ENERGIZE-T Phase 3 clinical trials in thalassemia patients with distinct transfusion dependency, commencing a Phase 2/3 trial for mitapivat in sickle cell disease and holding an investor day in Q4/21, during which Agios will provide an update on its progress with mitapivat and its R&D pipeline programs.


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Disclosures from H.C. Wainwright & Co., Agios Pharmaceuticals, Inc., July 30, 2021

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Michael G. King, Jr. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Agios Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of June 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Agios Pharmaceuticals, Inc.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did not receive compensation from Agios Pharmaceuticals, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Agios Pharmaceuticals, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

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