AGIO Q2 Earnings Lag, Stock Down on Missing Pediatric Study Goal

Core Insights - Agios Pharmaceuticals reported a wider loss of $1.69 per share in Q2 2024 compared to the Zacks Consensus Estimate of a loss of $1.58 and a loss of $1.51 in the same quarter last year [1] - Revenues for the quarter were $8.6 million, missing the Zacks Consensus Estimate of $9.4 million, but up from $6.7 million in the year-ago quarter [1] Financial Performance - Revenues were entirely from product sales of Pyrukynd, which saw a 5% sequential increase due to higher patient demand, with 128 patients on therapy, a 7% increase from Q1 2024 [2] - Research and development expenses rose 12% year over year to $77.4 million, primarily due to costs associated with the siRNA TMPRSS6 program [2] - Selling, general and administrative expenses increased 17% year over year to $35.5 million, driven by preparations for a potential launch of Pyrukynd in thalassemia [3] - As of June 30, 2024, cash and marketable securities totaled $645.3 million, down from $714.3 million as of March 31, 2024 [3] Pipeline Developments - The phase III ACTIVATE-KidsT study for Pyrukynd in children did not meet the primary endpoint, leading to a 4.1% drop in shares [4] - Despite the study miss, management noted that 28.1% of patients in the mitapivat arm achieved the primary endpoint compared to 11.8% in the placebo arm, indicating clinically meaningful results [6] - Agios is also evaluating Pyrukynd in other studies for thalassemia and sickle cell disease, with plans for FDA label expansion by the end of 2024 [7][8] - A deal with Royalty Pharma for royalty rights on vorasidenib could yield an upfront payment of $905 million upon FDA approval [8] Market Performance - Year-to-date, Agios shares have surged 99.8%, significantly outperforming the industry growth of 3.9% [4]