What is Agios's latest dividend and current dividend yield?

What does Agios do and what are its main business segments?

What guidance did Agios's management provide for the next earnings period?

What factors drove the changes in Agios's revenue and profit?

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What were the key takeaways from Agios's earnings call?

What is the revenue and EPS growth rate for Agios year over year?

- **Revenue Growth**: Q4 2025 U.S. PK deficiency revenue of $16 million, up 86% YoY, with 2026 guidance of $45-50 million.
- **Thalassemia Launch Momentum**: 44 AQVESME prescriptions in first 5 weeks, targeting 10-12 week treatment initiation timeline.
- **Pipeline Catalysts**: Phase II Tebapivat data in sickle cell disease (H2 2026) and MDS (H1 2026), plus AG-236/AG-181 early-stage trials.
- **Financial Strength**: $1.2 billion cash balance supports disciplined spending and growth initiatives.
- **Strategic Focus**: Maximize U.S. thalassemia launch while advancing PK activators into high-value indications.

**【CEO Summary Section】**
- Agios reported Q4 2025 revenue of $20 million for PYRUKYND, with full-year revenue reaching $54 million, reflecting 86% YoY growth in Q4 U.S. sales.
- The U.S. launch of AQVESME for thalassemia began in December 2025, with 44 prescriptions written in the first 5 weeks, targeting transfusion-dependent and symptomatic non-transfusion-dependent patients.
- Strategic priorities include maximizing the AQVESME launch, advancing PK activators (mitapivat and Tebapivat) into sickle cell disease and MDS, and advancing early-stage pipeline programs AG-236 and AG-181.
- The company ended 2025 with $1.2 billion in cash, supporting near-term growth and pipeline development.

**【CFO Financial Commentary】**
- Q4 2025 GAAP net loss was $10.3 million, with Non-GAAP operating expenses of $139.7 million, reflecting disciplined cost management.
- U.S. PK deficiency revenue guidance for 2026 is $45-50 million, driven by AQVESME adoption.
- Operating expenses are expected to remain flat in 2026, with investments focused on the AQVESME launch and strategic pipeline opportunities.
- Cash reserves of $1.2 billion provide flexibility for commercial expansion and R&D.

**【Chief Commercial Officer Highlights】**
- AQVESME REMS certification process is streamlined, with no significant barriers reported by prescribers.
- Treatment initiation timeline is 10-12 weeks post-prescription due to insurance authorization and baseline liver testing requirements.
- Early launch metrics show geographic diversity in prescribers and patient profiles aligning with target demographics.
- Global commercial partnerships in Europe and GCC regions aim to expand access beyond the U.S.

**【Chief Medical Officer Highlights】**
- Phase II Tebapivat trial in sickle cell disease completed enrollment, with top-line data expected in H2 2026.
- Phase IIb Tebapivat trial in MDS targeting transfusion independence, with top-line data anticipated in H1 2026.
- Early-stage programs AG-236 (siRNA for polycythemia vera) and AG-181 (PKU stabilizer) progressing toward Phase I/II trials.
- Pre-sNDA meeting with FDA for mitapivat in sickle cell disease scheduled for Q1 2026 to discuss regulatory path.

**【Q&A Highlights】**
- **AQVESME Launch Dynamics**: 10-12 week lag from prescription to treatment initiation due to insurance and liver testing; Q1 2026 revenue will reflect early prescriber activity.
- **Sickle Cell Disease Strategy**: Tebapivat Phase II trial focuses on higher potency PK activation; potential for accelerated approval if data support clinical benefit.
- **Financial Outlook**: Path to profitability via U.S. thalassemia and PK deficiency revenue, with gated investments in sickle cell disease.
- **Global Expansion**: GCC partnerships aim to replicate U.S. launch success in regions with high unmet need.


Agios Pharmaceuticals, Inc. (AGIO) Q4 2025 Earnings Call Transcript

- **Thalassemia Regulatory Progress**: PDUFA date extended to December 7, 2025; Saudi Arabia approval and European CHMP positive opinion.
- **Sickle Cell Disease Milestone**: Phase III RISE UP trial results expected by year-end.
- **Financial Strength**: $1.3 billion cash balance supports U.S. launches and pipeline expansion.
- **Pipeline Momentum**: Tebapivat Phase IIb trial enrollment complete; AG-181 and AG-236 in early-stage development.
- **Commercial Readiness**: Global partnerships and U.S. REMS-compliant launch preparation.

**【CEO Summary Section】**
- Extended PDUFA date for thalassemia to December 7, 2025, with FDA requesting a REMS program.
- Received Saudi Arabia approval for PYRUKYND in thalassemia and positive CHMP opinion for European market.
- Anticipate top-line results from the Phase III RISE UP trial in sickle cell disease by year-end.
- Completed enrollment in the Phase IIb trial of Tebapivat for lower-risk MDS, with data expected early 2026.

**【CFO Financial Commentary】**
- Q3 2025 net revenue: $12.9 million (44% YoY increase, 3% QoQ growth).
- R&D expenses: $86.8 million (14% YoY increase) due to clinical trial costs.
- SG&A expenses: $41.3 million (7% YoY increase) for launch preparation.
- Cash balance: $1.3 billion, supporting U.S. launches and pipeline advancement.

**【CCO Commercial Highlights】**
- 262 patients enrolled in PK deficiency program, 149 on therapy (5% QoQ increase).
- Global partnerships with NewBridge (GCC) and Avanzanite (Europe) for capital-efficient launches.
- U.S. launch readiness despite REMS, with high-touch patient services infrastructure.

**【CMO R&D Updates】**
- PYRUKYND approved in Saudi Arabia and awaiting U.S. PDUFA decision; CHMP positive opinion for Europe.
- Tebapivat Phase IIb trial completed enrollment; AG-181 and AG-236 in early-stage trials.
- RISE UP trial on track for year-end top-line results.

**【Q&A Highlights】**
- REMS program details under review; no impact on European or Saudi launches expected.
- BD strategy focuses on rare diseases with best-in-class potential; no timing linked to RISE UP results.
- Liver monitoring requirements consistent across geographies; no additional hepatocellular injury events observed.


Agios Pharmaceuticals, Inc. (AGIO) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 net revenue of $12.5M (+45% YoY, +44% QoQ) driven by PKD demand and specialty pharmacy expansion.
- **Pipeline Momentum**: PYRUKYND Phase III thalassemia readout pending FDA decision (PDUFA 9/7/25); RISE UP sickle cell Phase III data expected Q4 2025.
- **Financial Strength**: $1.3B cash balance supports disciplined investment in U.S. launches and pipeline expansion.
- **Commercial Readiness**: 40-person U.S. sales force prepared for thalassemia launch; GCC and Europe partnerships enable ex-U.S. commercialization.
- **R&D Progress**: Tebapivat Phase II in MDS and AG-236 Phase I in polycythemia vera on track; no safety profile changes reported.


**【CEO Opening Remarks】**
- 2025 is a breakout year with a multibillion-dollar opportunity for PYRUKYND in thalassemia and sickle cell disease.
- Key near-term catalysts include FDA PDUFA date (September 7) for thalassemia, Phase III RISE UP trial readout for sickle cell disease, and tebapivat Phase IIb data in MDS.
- Cash position of $1.3 billion supports disciplined investment in commercialization and pipeline expansion.

**【CFO Financial Commentary】**
- Q2 2025 net revenue: $12.5 million (45% YoY growth, 44% QoQ growth) driven by PKD demand and specialty pharmacy processing.
- R&D expenses: $91.9 million (includes $10M milestone payment to Alnylam for AG-236).
- SG&A expenses: $45.9 million (10% YoY increase for thalassemia launch preparation).
- Full-year 2025 net revenue expected to show modest growth due to PKD demand variability and potential thalassemia launch timing.

**【Commercial Highlights (Tsveta Milanova)】**
- 248 patients enrolled in PYRUKYND (6% QoQ increase), 142 on active treatment (4% QoQ increase).
- U.S. launch readiness for thalassemia: 40-person sales force, payer engagement, and disease education programs.
- GCC partnership with NewBridge Pharmaceuticals for Saudi Arabia/UAE launches; Europe partnership with Avanzanite Bioscience for ex-U.S. commercialization.

**【R&D Updates (Sarah Gheuens)】**
- PYRUKYND Phase III ENERGIZE/ENERGIZE-T trials show statistically significant hemoglobin improvement and transfusion reduction in thalassemia.
- RISE UP Phase II data support Phase III trial design for sickle cell disease (primary endpoints: hemoglobin response and pain crisis reduction).
- Tebapivat Phase II trial in MDS and AG-236 Phase I trial in polycythemia vera progressing on track.

**【Q&A Highlights】**
- **Safety Profile**: No new safety signals reported; hepatocellular injury monitoring protocols remain consistent across trials.
- **Thalassemia Launch Timing**: Q4 2025 revenues expected to be minimal due to PDUFA timing; full launch impact in 2026.
- **Pediatric Thalassemia**: Regulatory filing contingent on adult trial data; pediatric trials planned post-approval.
- **PKU Pipeline**: AG-181 Phase I trial progressing; no changes to development plans despite recent competitor approvals.
- **Commercial Spend**: SG&A expenses to increase modestly post-approval for U.S. launch execution.


Agios Pharmaceuticals, Inc. (AGIO) Q2 2025 Earnings Call Transcript

- **Financial Strength**: $1.4B cash enables independent execution of pipeline through 2026 launches.
- **Thalassemia Milestone**: FDA PDUFA date set for September 7, 2025; no advisory committee planned.
- **Sickle Cell Expansion**: Dual PK activator strategy (mitapivat, tebapivat) to address unmet need post-Oxbryta withdrawal.
- **Commercial Readiness**: Expanded U.S. sales team and disease education campaigns position for thalassemia launch Q4 2025.
- **Pipeline Momentum**: Phase 2 tebapivat study for sickle cell to begin mid-2025; AG-236 IND filing expected mid-2025.

**【CEO Opening Remarks】**
- Agios maintains a strong financial position with $1.4B cash on hand, enabling independent execution of pipeline programs.
- PYRUKYND (mitapivat) is on track for U.S. thalassemia approval in September 2025 and sickle cell disease launch in 2026, targeting a multibillion-dollar opportunity.
- 2025 priorities include maximizing PYRUKYND franchise, advancing mid-stage programs (tebapivat, AG-236), and disciplined capital allocation.

**【CMO Clinical Updates】**
- **Thalassemia**: Positive Phase 3 results for mitapivat in both transfusion-dependent and non-transfusion-dependent patients. FDA review ongoing with no advisory committee planned; PDUFA date set for September 7, 2025.
- **Sickle Cell Disease**: Phase 3 RISE UP study (mitapivat) enrolling over 200 patients; top-line data expected late 2025. Phase 2 tebapivat study for sickle cell to begin mid-2025 with 56-patient enrollment.
- **MDS**: Phase 2b tebapivat study in low-risk MDS on track for year-end enrollment; data readout expected early 2026.

**【CCO Commercial Strategy】**
- U.S. thalassemia launch preparation includes: 
  - Disease state education campaigns in multiple languages (Cantonese, Mandarin, Arabic)
  - Expanded sales team (double size of PK deficiency team)
  - Payer engagement through pre-approval information exchanges
- 6,000 adult thalassemia patients in the U.S.; initial launch focus on 65% of transfusion-dependent and symptomatic non-transfusion-dependent patients.
- PYRUKYND revenue in Q1 2025: $8.7M (6% YoY growth, 19% QoQ decline due to Q4 2024 stocking)

**【CFO Financial Highlights】**
- Q1 2025 financials: 
  - Revenue: $8.7M (6% YoY growth)
  - R&D expenses: $72.7M (+$4.1M YoY due to clinical trial costs)
  - SG&A expenses: $41.5M (+$10.5M YoY for commercial expansion)
- Cash balance: $1.4B, sufficient to fund pipeline through 2026 launches without external financing.

**【Q&A Key Takeaways】**
- **FDA Engagement**: No advisory committee planned for thalassemia; regulatory review progressing as expected.
- **Sickle Cell Dynamics**: Oxbryta withdrawal strengthens unmet need; Agios plans to leverage two distinct PK activators (mitapivat, tebapivat) for broad patient reach.
- **Ex-U.S. Strategy**: Partnering with Newbridge in Gulf Region; Europe to follow similar revenue-sharing model.
- **Pipeline Expansion**: New Chief Corporate Development Officer (Krishnan Viswanadhan) to enhance BD capabilities while prioritizing internal pipeline advancement.


Agios Pharmaceuticals, Inc. (AGIO) Q1 2025 Earnings Call Transcript

- **2025 Breakout Year**: Potential thalassemia launch in Q4 2025 and SCD filing in 2026 could create $3B+ total addressable market.
- **Clinical Momentum**: 100% Phase 3 enrollment in SCD, positive pediatric PKD data, and Tebapivat MDS enrollment on track.
- **Financial Strength**: $1.5B cash balance supports independent execution; 2024 Pyrukynd revenue grew 51% to $10.7M.
- **Thalassemia Opportunity**: 4,000 targeted US patients with no approved therapies; 65% of market addressable at launch.
- **Dual PK Activator Strategy**: Mitapivat and Tebapivat position Agios to capture >50% SCD market share.

**【CEO Summary Section】**
- Agios achieved significant clinical and commercial progress in 2024, including the filing for Pyrukynd in thalassemia and completion of Phase 3 enrollment for sickle cell disease (SCD). 
- 2025 priorities: (1) Maximize Pyrukynd franchise with potential thalassemia launch in September 2025 and SCD filing in 2026; (2) Advance mid-stage pipeline (Tebapivat in MDS/SCD, AG-236 for PV); (3) Maintain financial independence with $1.5B cash balance.

**【CMO Clinical Updates】**
- **Pediatric PKD**: Mitapivat met primary endpoint in non-transfused patients (31.6% vs 0% response), supporting broader PKD label expansion.
- **Thalassemia**: ENERGIZE studies showed durable hemoglobin improvement and reduced transfusion burden, with FDA PDUFA date set for September 7, 2025.
- **SCD**: Phase 3 RISE UP study enrollment complete (200+ patients), targeting 2025 readout and 2026 launch.
- **Tebapivat**: Phase 2b MDS enrollment on track for 2025 completion; Phase 2 SCD initiation planned for mid-2025.

**【CCO Commercial Readiness】**
- Thalassemia launch preparation: doubled sales force to ~40 reps, disease state education campaign, and payer engagement.
- ~65% of US thalassemia patients (4,000 adults) initially targeted; 2/3 of US thalassemia patients lack approved therapies.
- Gulf region: Saudi Arabia prioritized for ex-US launch, leveraging NewBridge partnership.

**【CFO Financial Highlights】**
- Q4 2024 Pyrukynd revenue: $10.7M (51% YoY growth), driven by PKD launch momentum.
- R&D expenses: $82.8M (6% YoY increase) due to workforce expansion.
- SG&A expenses: $51.7M (46% YoY increase) for commercial readiness.
- Cash balance: $1.5B, sufficient for near-term launches and pipeline advancement.

**【Key Q&A Takeaways】**
- **Safety Monitoring**: Mitapivat liver safety profile stable; monthly ALT monitoring added to SCD trial OLE phase.
- **Peak Sales Potential**: Thalassemia could generate $1B+ annual revenue; SCD peak sales >$2B with dual PK activator strategy.
- **Pediatric Development**: PKD pediatric data informs future thalassemia/SCD trials, reducing regulatory uncertainty.
- **FDA Panel**: No panel requested; existing data suffices for thalassemia filing.
- **International Timing**: EU and Gulf approvals expected post-US launch, with commercialization lag due to reimbursement processes.

Actual												-0.59	-1.31	-1.43	-1.41	26.95	-1.41	-1.48	-1.74	-1.74	-1.68	-1.49	0.68	-1.47	-1.51	-1.64	-1.71	-1.45	-1.69	16.22	-1.44	-1.55	-1.93	-1.78	-1.86
Forecast												-1.6657	-1.3637	-1.3592	-1.3072	-1.2926	-1.3255	-1.567	-1.6645	-1.74	-1.7467	-1.7643	-1.3689	-1.7011	-1.5613	-1.7025	-1.6478	-1.6478	-1.6017	15.2158	-1.6908	-1.7706	-1.8075	-1.8965	-1.9537
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+64.58%	+3.94%	-5.21%	-7.86%	+2184.95%	-6.37%	+5.55%	-4.54%	0.00%	+3.82%	+15.55%	+149.67%	+13.59%	+3.29%	+3.67%	-3.77%	+12.00%	-5.51%	+6.60%	+14.83%	+12.46%	-6.78%	+6.14%	+4.80%

Actual	--	--	--	--	--	--	--	--	--	--	--	87.10M	37.35M	34.71M	44.05M	0	0	0	0	832.00K	5.58M	3.52M	4.31M	5.60M	6.70M	7.40M	7.10M	8.20M	8.60M	9.00M	10.70M	8.70M	12.50M	12.90M	19.97M
Forecast	--	--	--	--	--	--	--	--	--	--	--	31.12M	37.14M	38.12M	39.86M	47.23M	2.49M	2.55M	614.70K	2.71M	2.91M	5.27M	4.54M	5.24M	6.46M	7.53M	7.92M	8.37M	9.34M	9.44M	9.37M	9.68M	9.52M	10.67M	12.09M
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+179.85%	+0.56%	-8.97%	+10.50%	-100.00%	-100.00%	-100.00%	-100.00%	-69.32%	+92.12%	-33.26%	-4.97%	+6.81%	+3.67%	-1.67%	-10.37%	-2.01%	-7.96%	-4.64%	+14.15%	-10.13%	+31.35%	+20.95%	+65.14%

AGIO

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AGIO Q4 2025 Earnings

Earnings Call

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AGIO

AGIO fundamentals

AGIO Q4 2025 Earnings

Earnings Call

AGIO Earnings Call Summary for Q4/20258:00 AM on Feb 12, 2026

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AGIO Earnings Call Summary for Q2/20258:00 AM on Jul 31, 2025

AGIO Earnings Call Summary for Q1/20258:00 AM on May 1, 2025

AGIO Earnings Call Summary for Q4/20248:00 AM on Feb 13, 2025

You can ask Aime