On February 17, 2026, Commodore Capital disclosed in a U.S. Securities and Exchange Commission (SEC) filing that it sold all 2,338,287 shares of Agios Pharmaceuticals (NASDAQ:AGIO) in the fourth quarter, an estimated $93.86 million transaction. What happened According to a filing with the Securities and Exchange Commission dated February 17, 2026, Commodore Capital sold all 2,338,287 shares of Agios Pharmaceuticals in the fourth quarter. The position’s quarter-end value decreased by $93.86 million as a r ...

On February 17, 2026, Rock Springs Capital Management LP disclosed in an SEC filing that it sold 159,379 shares of Agios Pharmaceuticals (NASDAQ:AGIO) in the fourth quarter, an estimated $5.59 million transaction based on quarterly average pricing. What happened According to its SEC filing dated February 17, 2026, Rock Springs Capital Management sold 159,379 shares of Agios Pharmaceuticals in the fourth quarter. The estimated transaction value was $5.59 million, based on the average closing price for the ...

Financial Performance - Agios Pharmaceuticals reported a loss of $1.85 per share in Q4 2025, which is narrower than the Zacks Consensus Estimate of a loss of $1.97 and compared to a loss of $1.74 per share in the same quarter last year [1][10] - Total revenues for Q4 2025 were $20 million, exceeding the Zacks Consensus Estimate of $10 million [1] - For the full year 2025, total revenues reached $54 million, reflecting a 48% year-over-year increase [10] Product Performance - The lead drug, mitapivat, is marketed as Pyrukynd and Aqvesme, with Pyrukynd approved for treating hemolytic anemia in adults with pyruvate kinase deficiency and Aqvesme for anemia in adults with alpha- or beta-thalassemia [2] - Pyrukynd generated $16 million in product revenues in the U.S., marking a 49% year-over-year increase and a 24% sequential increase [5] - Aqvesme was launched in the U.S. in December 2025 and is reported to have a strong start [3] Market Developments - Outside the U.S., mitapivat continues to be marketed as Pyrukynd for both PK deficiency and thalassemia indications, with a positive opinion from the European Medicines Agency for label expansion in thalassemia [4] - Agios recorded $4 million in revenues from Pyrukynd in the ex-U.S. market, primarily due to inventory stocking as the market transitioned to commercial supply [8] Research and Development - Research and development expenses increased by approximately 6.4% year-over-year to $88.1 million in Q4 2025, driven by higher costs related to pipeline development [9] - The company is developing mitapivat for sickle cell disease (SCD) and plans to engage with the FDA in Q1 2026 before filing for approval [11][13] - Agios is also developing another candidate, tebapivat, for SCD, with patient enrollment completed and top-line results expected in the second half of 2026 [13] Stock Performance - Over the past year, Agios' stock has decreased by 15.7%, while the industry has seen an increase of 17.9% [4]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Performance - The company reported a net loss of $412.8 million for the year ended December 31, 2025, following a net income of $673.7 million in 2024, primarily due to the sale of Vorasidenib Royalty Rights[457]. - As of December 31, 2025, the company had an accumulated deficit of $561.7 million, indicating ongoing financial challenges[457]. - Total product revenue for 2025 reached $54.03 million, an increase of $17.5 million compared to 2024, driven by a $12.8 million increase in U.S. product revenue and a $4.7 million increase in rest of world product revenue[511]. - U.S. product revenue in 2025 was $49.17 million, up from $36.40 million in 2024, primarily due to increased volume associated with PYRUKYND®[511]. - Rest of world product revenue increased to $4.86 million in 2025 from $0.10 million in 2024, attributed to increased volume associated with the Avanzanite Agreement[511]. - Total revenue for 2024 was $36.50 million, an increase of $9.7 million compared to 2023, mainly due to increased U.S. product revenue from PYRUKYND®[512]. - Cash used in operating activities was $373.0 million in 2025, slightly improved from $389.8 million in 2024, with cash received from interest income at $59.0 million and product revenues at $50.5 million[527]. - Cash provided by investing activities was $377.2 million in 2025, primarily due to higher proceeds from maturities and sales of marketable securities[530]. - The cash, cash equivalents, and marketable securities balance was $1.2 billion at December 31, 2025, providing a strong liquidity position[525]. - The company had cash, cash equivalents, and marketable securities of $1.5 billion as of December 31, 2024, indicating a decrease of $300 million year-over-year[545]. Product Development and Approvals - The lead product candidate, mitapivat, is approved in the U.S. and Saudi Arabia for treating hemolytic anemias, with a marketing authorization application submitted to the EMA in December 2024[446][447]. - The company plans to submit a U.S. marketing application for mitapivat in sickle cell disease in Q1 2026[448]. - Vorasidenib received FDA approval in August 2024, leading to a $200 million milestone payment recognized in the financial statements for the year ended December 31, 2024[454]. - In December 2025, the FDA approved mitapivat as AQVESME™ for anemia in adults with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia, marking it as the only FDA-approved treatment for both conditions[467]. - The company is evaluating mitapivat for pediatric patients with PK deficiency and has received orphan drug designations for thalassemia and SCD from the FDA and EMA[471]. - A pre-sNDA meeting with the FDA is scheduled for Q1 2026 to discuss a U.S. marketing application for mitapivat in SCD[470]. - The company has full ownership rights to PYRUKYND® and AQVESME™ and plans to fund future development and commercialization costs[472]. - The company achieved clinical proof-of-concept in the phase 2a trial of tebapivat, with 40% of patients with low transfusion burden achieving transfusion independence[486]. - The phase 2b portion of the tebapivat trial is set to initiate in Q3 2024, with enrollment completed by September 2025 and topline data expected in the first half of 2026[486]. - The company initiated a phase 1 clinical trial of AG-181 in healthy volunteers in Q1 2024, with plans for a phase 1b trial in patients with PKU in H1 2026[487]. - AG-236, targeting PV, has completed IND filing with the FDA and initiated a phase 1 clinical trial in July 2025, with topline data expected in H1 2026[488]. Clinical Trial Results - The phase 3 trial for mitapivat in SCD showed that 40.6% of patients achieved a hemoglobin response, compared to 2.9% in the placebo group, with a statistically significant p-value of <0.0001[476]. - The annualized rate of sickle cell pain crises (SCPCs) was 2.62 in the mitapivat arm versus 3.05 in the placebo arm, although this reduction did not achieve statistical significance[476]. - In the ACTIVATE-kidsT study, 28.1% of patients in the mitapivat arm achieved a transfusion reduction response, compared to 11.8% in the placebo arm[479]. - The ACTIVATE-kids study reported that 31.6% of patients in the mitapivat arm achieved a hemoglobin response, while 0% in the placebo arm, with a confidence interval of 10.8% to 52.7%[480]. Research and Development Expenses - Research and development expenses are expected to increase as product candidate development progresses, with significant uncertainties regarding costs and timelines[463][464]. - Selling, general and administrative expenses are anticipated to increase to support ongoing research and commercialization activities, including hiring additional personnel[490]. - Total operating expenses increased by $63.9 million in 2025 compared to 2024, primarily due to a $38.2 million rise in research and development expenses and a $23.5 million increase in selling, general and administrative expenses[513]. - Research and development expenses totaled $339.5 million in 2025, up from $301.3 million in 2024, driven by a $28.0 million increase in direct expenses and a $10.2 million increase in indirect expenses[515]. - The total research and development expenses for 2024 were $301.3 million, reflecting a $5.8 million increase from 2023, primarily due to higher indirect expenses[516]. Strategic Agreements and Future Plans - The company entered into a license agreement with Alnylam for AG-236, a potential treatment for polycythemia vera, with an upfront payment of $17.5 million recognized in R&D expenses[450][451]. - The company has established distribution agreements for PYRUKYND® in the Gulf Council Countries and the European Economic Area, expanding its market reach[459]. - A distribution agreement was established with NewBridge Pharmaceuticals for the commercialization of PYRUKYND® in the GCC region[472]. - The company anticipates increased expenses related to the commercialization of PYRUKYND® and AQVESME™, as well as potential future marketing approvals for other product candidates[535]. - The company may need to pay up to an additional $120 million in potential development and regulatory milestones under a license agreement with Alnylam, contingent upon future events[544]. - The company may pursue opportunistic debt offerings and equity or equity-linked offerings to raise additional capital, which could dilute existing stockholders' ownership[537]. - The company’s future capital requirements will depend on various factors, including the success of its commercialization activities and the ability to establish collaborations on favorable terms[540]. Risk Factors - The company is exposed to interest rate risk due to its investments primarily in short-term marketable securities, which could fall in value if market interest rates increase[545]. - The company is subject to fluctuations in foreign currency exchange rates due to contracts with CROs and CMOs located in Asia and Europe, but currently does not hedge this risk[546]. - The company has significant contractual obligations totaling $42.7 million for operating leases, with $18.5 million due within one year[541]. - The company has no off-balance sheet arrangements as defined under applicable SEC rules, indicating a straightforward financial position[539].

Financial Data and Key Metrics Changes - In Q4 2025, PYRUKYND generated $20 million in net revenue, an 86% increase year-over-year and a 55% sequential increase from $13 million in Q3 2025 [7][10] - Full-year 2025 revenue for PYRUKND reached $54 million, reflecting robust year-on-year growth [7][10] - The company ended 2025 with approximately $1.2 billion in cash, providing flexibility for future investments [8][11] Business Line Data and Key Metrics Changes - U.S. revenue for PYRUKND in Q4 was $16 million, driven by commercial focus in PK deficiency and favorable growth adjustments [10] - Ex-U.S. revenue was $4 million in Q4, primarily due to inventory stocking ahead of demand [11] - Cost of sales for Q4 was $1.9 million, while R&D expenses were $88.1 million, reflecting an increase associated with advancing the pipeline [11] Market Data and Key Metrics Changes - The U.S. launch of ACTIVASE for thalassemia is underway, with expectations for U.S. PK deficiency revenues in 2026 to be between $45-$50 million [10] - The company anticipates a sequential decline in ex-U.S. revenues into Q1 2026 [11] Company Strategy and Development Direction - The company outlined its 2026 strategic priorities, focusing on executing the launch of Pyrukynd, expanding the PK activation franchise, advancing early-stage pipeline programs, and maintaining financial discipline [5][6] - The company aims to leverage its existing commercial presence in thalassemia and PK deficiency to achieve profitability [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early market response to ACTIVASE, noting strong engagement from physicians and patients [16] - The company is preparing for a pre-sNDA meeting with the FDA regarding mitapivat for sickle cell disease, which is a critical step in defining the regulatory path [25][44] Other Important Information - The company has completed enrollment in the phase II sickle cell disease trial of tebapivat, with top-line results expected in the second half of 2026 [8][20] - The company is committed to financial discipline, anticipating operating expenses in 2026 to be roughly flat compared to 2025 [12] Q&A Session Summary Question: On the ACTIVASE launch and prescription updates - Management noted that early demand for ACTIVASE is encouraging, with 44 prescriptions written by REMS-certified physicians in the first five weeks of launch [31] - It is expected that prescriptions will grow ahead of revenues due to a 10-12 week conversion time from prescription to treatment initiation [31][32] Question: On sickle cell and tebapivat expectations - Management indicated that the phase II tebapivat trial is a dose-finding trial, and they are excited about the potential hemoglobin response based on previous data [35][36] Question: On payer dynamics and SG&A changes - The payer mix for thalassemia is similar to PK deficiency, with most patients under commercial payers, and initial market access is expected to occur through medical exceptions [93] - SG&A expenses will need to scale up for sickle cell, but the existing infrastructure from PK deficiency and thalassemia will be leveraged [95]

Financial Data and Key Metrics Changes - In Q4 2025, Agios Pharmaceuticals reported net revenue of $20 million from PYRUKYND, an increase of 86% year-over-year and a sequential increase of 55% compared to $13 million in Q3 2025 [10][11] - Full-year 2025 revenue for PYRUKYND reached $54 million, reflecting robust year-on-year growth [7][10] - The company ended Q4 2025 with approximately $1.2 billion in cash, cash equivalents, and marketable securities, providing flexibility for future investments [8][11] Business Line Data and Key Metrics Changes - U.S. revenue for PYRUKYND in Q4 was $16 million, driven by commercial focus in PK deficiency and favorable growth adjustments [10][11] - Ex-U.S. revenue was $4 million in Q4, primarily reflecting inventory stocking ahead of demand from PK deficiency patients in Europe [11] - The company anticipates U.S. PK deficiency revenues to be in the range of $45-$50 million in 2026 [10] Market Data and Key Metrics Changes - The ACTIVASE launch for thalassemia in the U.S. is underway, with strong early demand and 44 prescriptions written by REMS-certified physicians as of January 30 [15][41] - The company has received approval for mitapivat for thalassemia in two regions, with plans for commercialization in Europe and the GCC [18][19] Company Strategy and Development Direction - Agios has outlined its 2026 strategic priorities, focusing on executing the ACTIVASE launch, expanding the PK activation franchise, advancing early-stage pipeline programs, and maintaining financial discipline [5][6] - The company aims to leverage its existing commercial presence in thalassemia and PK deficiency to achieve profitability [12][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early market response to ACTIVASE, noting that physicians view its profile as addressing significant gaps in current treatment options for thalassemia [16][18] - The company anticipates a pivotal year ahead with multiple catalysts, including the pre-sNDA meeting for mitapivat and phase 2 data for tebapivat [25][26] Other Important Information - The company is committed to financial discipline, with operating expenses in 2026 expected to be roughly flat compared to 2025 [12] - Agios is focused on maximizing the launch of ACTIVASE while continuing to advance its pipeline programs [8][25] Q&A Session Summary Question: Can you provide insights on the ACTIVASE launch and prescription updates? - Management noted that early demand is encouraging, with 44 prescriptions written in the first five weeks of launch, and expects prescriptions to grow ahead of revenues due to a 10-12 week conversion time to treatment initiation [31][41] Question: What are the expectations for the phase 2 data in sickle cell disease? - Management indicated that the phase 2 tebapivat trial is a dose-finding study, and they are excited about the potential hemoglobin response based on previous data [35][36] Question: Can you discuss the payer dynamics for ACTIVASE? - The payer mix is similar to PK deficiency, with most patients under commercial payers, and initial access will occur through medical exceptions [93] Question: What is the rationale for higher dosing in lower-risk MDS? - Higher doses are being tested in MDS due to faster metabolism in patients compared to sickle cell disease, which is modeled after healthy volunteers [101] Question: How does the REMS program for thalassemia impact sickle cell disease? - Management believes that the experience gained from the thalassemia REMS program will provide a solid foundation for executing a similar program if needed for sickle cell disease [104]

Financial Data and Key Metrics Changes - In Q4 2025, Agios Pharmaceuticals reported worldwide PYRUKYND revenue of $20 million, an increase of 86% compared to Q4 2024, and a sequential increase of 55% from $13 million in Q3 2025 [9][10] - Full-year 2025 revenue for PYRUKYND reached $54 million, reflecting robust year-on-year growth [5][9] - The company ended Q4 2025 with approximately $1.2 billion in cash, cash equivalents, and marketable securities, providing flexibility for future investments [6][10] Business Line Data and Key Metrics Changes - U.S. fourth quarter revenues for PYRUKYND were $16 million, driven by commercial focus in PK deficiency and favorable growth adjustments [9] - Ex-U.S. revenue was $4 million in Q4, primarily reflecting inventory stocking ahead of demand [10] - Cost of sales for Q4 was $1.9 million, R&D expenses were $88.1 million, and SG&A expenses were $51.6 million, roughly flat year-on-year [10] Market Data and Key Metrics Changes - The ACTIVASE launch for thalassemia in the U.S. is underway, with expectations for U.S. PK deficiency revenues in 2026 to be in the range of $45-$50 million [9][10] - The company anticipates a sequential decline in ex-U.S. revenues into Q1 2026 due to inventory adjustments [10] Company Strategy and Development Direction - The company outlined its 2026 strategic priorities, focusing on executing the ACTIVASE launch, expanding the PK activation franchise, advancing early-stage pipeline programs, and maintaining financial discipline [4][5] - Agios aims to leverage its capital-efficient global commercial model to focus investments on the U.S. market, which presents the most significant revenue opportunity [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early demand for ACTIVASE, noting strong engagement from physicians and a healthy breadth of early prescribers [14][40] - The company sees a clear path to profitability through its existing commercial presence in thalassemia and PK deficiency, with operating expenses expected to remain flat in 2026 [11][68] Other Important Information - The company received FDA approval for ACTIVASE on December 23, 2025, and the U.S. launch is underway with positive early feedback from physicians [18][19] - Enrollment in the phase II sickle cell disease trial of tebapivat is complete, with top-line results expected in the second half of 2026 [6][20] Q&A Session Summary Question: How does the ACTIVASE launch translate to treatment initiation and revenue recognition? - Management indicated that prescriptions are expected to grow ahead of revenues due to a 10-12 week conversion time from prescription to treatment initiation [29][30] Question: What are the expectations for the phase II data in sickle cell disease? - Management expressed excitement about the trial, noting that it is a dose-finding study aimed at exploring hemoglobin response [34][35] Question: What is the payer mix for ACTIVASE and how does it affect revenue? - The payer mix is similar to PK deficiency, with most patients under commercial payers, and initial market access will occur through medical exceptions [90] Question: What is the rationale for higher dosing in lower-risk MDS compared to sickle cell disease? - Higher doses in MDS are due to faster metabolism in MDS patients, while sickle cell patients metabolize the drug similarly to healthy volunteers [98] Question: What is the expected timeline for profitability? - Management has not provided specific timing but indicated that thalassemia presents a meaningful opportunity for profitability [68][70]

分组1 - Agios Pharmaceuticals reported a quarterly loss of $1.85 per share, which was better than the Zacks Consensus Estimate of a loss of $1.97, representing an earnings surprise of +6.25% [1] - The company posted revenues of $19.97 million for the quarter ended December 2025, exceeding the Zacks Consensus Estimate by 94.14%, compared to revenues of $10.73 million a year ago [2] - Over the last four quarters, Agios Pharmaceuticals has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] 分组2 - The stock has gained about 1.8% since the beginning of the year, outperforming the S&P 500's gain of 1.4% [3] - The current consensus EPS estimate for the coming quarter is -$1.80 on revenues of $12.52 million, and for the current fiscal year, it is -$6.77 on revenues of $79 million [7] - The Medical - Biomedical and Genetics industry, to which Agios Pharmaceuticals belongs, is currently in the top 36% of Zacks industries, indicating a favorable outlook [8]

Q4 and FY 2025 Financial Results and Business Highlights Conference call for investors and analysts 12 February 2026 4 2026 strategic priorities – driving long-term value creation | Execute high-impact launch for AQVESME | | --- | | (mitapivat) in thalassemia | | Potential to expand PK activation franchise into | | sickle cell disease and LR-MDS | | Unlock future value in hematology and other rare | | disease by advancing early-stage pipeline | | Ensure long-term sustainability through disciplined | | capit ...