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 pipeline.
"The company is rapidly rebooting and has made critical progress on various fronts," King wrote and listed some of its recent accomplishments.
During Q2/21, Agios filed a new drug application with the U.S. Food & Drug Administration and the European Medicines Agency for mitapivat for treatment of adults with pyruvate kinase deficiency.
The biopharma announced and presented, at the annual European Hematology Association (EMA) meeting, Phase 3 data from its ACTIVATE and ACTIVATE-T clinical trials of mitapivat in pyruvate kinase deficiency. The biopharma also presented at the EMA safety and efficacy data of mitapivat in thalassemia, which were positive.
Agios also launched two programs. One, myAgios, a patient support service, aims to more efficiently identify patients who qualify for any of its clinical trials, thereby ensuring more expedient enrollment. The second program is a share repurchase program of $1.2 billion.
As for Agios' Q2/21 financials, King noted the biopharma posted a net loss of $86.2 million ($86.2M), in line with H.C. Wainwright's estimated $86.3M. Spending, however, was modestly higher than expected in terms of research and development (R&D) expense and selling, general and administrative (SG&A) expense. On R&D, Agios spent $62.0M; H.C. Wainwright projected it to be $55.7M. For SG&A costs, Agios paid $31.4M versus H.C. Wainwright's forecast of $29.2M.
"We do 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 but increased its target price on the biopharma to $93 per share from $88. In comparison, Agios is currently trading at about $49.84 per share.
Three catalysts are on the horizon for this Massachusetts-based biopharma. One is starting the ENERGIZE and ENERGIZE-T Phase 3 clinical trials in thalassemia patients with distinct transfusion dependency. Another is commencing a Phase 2/3 trial for mitapivat in sickle cell disease. The third is holding an investor day in Q4/21, during which Agios will provide a update on its progress with mitapivat and its R&D pipeline programs.
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