What is the market's earnings forecast for Harmony next quarter?

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

What is Harmony's gross profit margin?

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

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

Did Harmony beat or miss consensus estimates last quarter?

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

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

- **Blockbuster Achievement**: WAKIX set to reach $1 billion in 2026, with Q4 2025 revenue up 21% YoY to $243.8 million.
- **Pediatric Expansion**: FDA approval for pediatric cataplexy (≥6 years) adds 5% of narcolepsy market, with teams prepped for rapid uptake.
- **IP Defense Success**: 6/7 generic filers settled, delaying potential generic entry to March 2030 (if pediatric exclusivity granted).
- **Pipeline Momentum**: Pitolisant GR NDA submission in Q2 2026, and new CNS formulation for fatigue with 2042 patent protection.
- **Financial Resilience**: $882.5 million cash balance supports R&D and commercial expansion, with no debt.

**【CEO Summary Section】**
- **Revenue Milestone**: Q4 2025 net product revenue of $243.8 million, up 21% YoY, with full-year revenue of $868.5 million. 2026 guidance for WAKIX to reach $1 billion to $1.04 billion, achieving blockbuster status.
- **Patient Growth**: 8,500 average patients on WAKIX, with 400+ new patients added per quarter for three consecutive quarters. Expansion into pediatric narcolepsy with FDA approval for cataplexy in patients ≥6 years.
- **IP Strategy**: Settled with 6 of 7 generic filers, delaying potential generic entry to March 2030 (if pediatric exclusivity granted). Ongoing litigation defense for core IP.
- **Pipeline Expansion**: Pitolisant GR (bioequivalent to WAKIX) NDA submission in Q2 2026, targeting PDUFA in Q1 2027. New CNS formulation for fatigue (e.g., multiple sclerosis) with patent protection until 2042.

**【CFO Financial Commentary】**
- **Financial Performance**: Q4 2025 non-GAAP net income of $33.4 million ($0.57 per share), driven by strong cash generation ($348.2 million in 2025). Cash balance of $882.5 million supports R&D and commercial expansion.
- **Expense Management**: Q4 operating expenses $136.7 million, up 50% YoY due to R&D investments, litigation costs, and commercial growth. 2026 R&D spend expected to increase with 5 Phase III trials.
- **Balance Sheet Strength**: Self-funding biotech with no debt, positioning for business development and pipeline expansion.

**【Q&A Highlights】**
- **EPX-100 (Dravet Syndrome)**: 50% median seizure reduction in 50% of patients, with favorable safety profile (no special monitoring required). PDUFA target 2028.
- **Orexin-2 Receptor Agonist**: Phase I PK data expected mid-2026, targeting fatigue in broader CNS indications. Competitive with Takeda's pipeline but leveraging unique histaminergic mechanism.
- **Sales Force Expansion**: 20% increase in field teams (e.g., +50% in field reimbursement) to support WAKIX growth, with GR launch preparation beginning 2026.
- **IP Risk Mitigation**: 6/7 generic filers settled, reducing generic entry risk. Pediatric exclusivity extension (if granted) delays LOE to March 2030.


Harmony Biosciences Holdings, Inc.(HRMY)-20260224-2025 Q4 Earnings call transcript

- **Revenue Growth Surpasses Expectations**: Q3 2025 net revenue of $239.5 million (+29% YoY), with 500 new patients quarterly added, raising full-year guidance to $845-$865 million.
- **WAKIX Blockbuster Trajectory**: On track for $1 billion+ annual revenue in narcolepsy by 2026, driven by 8,100 average patients and stable NT1/NT2 split.
- **Pipeline Momentum**: Pitolisant HD Phase III trials on track for Q4 2025 initiation, GR formulation showing 100% tolerability in dosing study.
- **Financial Strength**: $778 million cash balance, non-GAAP EPS of $1.08, and confidence in 5 Phase III programs by year-end.
- **Strategic Focus**: CEO emphasizes CNS innovation and M&A potential, with pipeline investments supporting long-term growth.

**【CEO Summary Section】**
- Reported Q3 2025 net revenue of $239.5 million, up 29% YoY, with 500 average new patients added quarterly, exceeding prior guidance.
- Raised full-year revenue guidance to $845-$865 million, targeting $1 billion+ annual revenue for WAKIX in narcolepsy by 2026.
- Highlighted robust pipeline progress, including IND submission for pitolisant HD and Phase III trials for narcolepsy and idiopathic hypersomnia (IH).

**【CCO Update】**
- WAKIX achieved 8,100 average patients on therapy, with 500 new quarterly adds, driven by improved sales execution, payer coverage, and patient support.
- Emphasized differentiation of WAKIX as the only nonscheduled treatment, with 45% NT1 and 55% NT2 patient split remaining stable.
- Discussed life cycle management strategies for pitolisant GR (fast-to-market, no titration) and HD (enhanced efficacy, fatigue indication).

**【CMO Pipeline Update】**
- Pitolisant HD Phase III trials for narcolepsy and IH on track to initiate Q4 2025, targeting PDUFA dates in 2028.
- Pitolisant GR dosing study showed 100% tolerability at 17.8mg, with 98% tolerating 35.6mg, supporting Q1 2027 BE study readout.
- Orexin-2 agonist (BP1.15205) Phase I study set to begin Q4 2025, leveraging preclinical data showing efficacy at low doses.

**【CFO Financials】**
- Q3 2025 non-GAAP net income of $63.5 million ($1.08 EPS), up 11% YoY, with cash balance of $778 million.
- Raised 2025 revenue guidance to $845-$865 million, driven by WAKIX demand and pipeline investments.
- Projected 5 Phase III programs by year-end, including $4 million milestone for orexin-2 Phase I.

**【Q&A Highlights】**
- **Sustainability of Growth**: CCO cited strong fundamentals, execution, and pipeline confidence for continued patient adds beyond 2026.
- **Orexin Competition**: CCO emphasized WAKIX's position as a polytherapy backbone, with historical resilience to new entrants.
- **Pipeline Strategy**: CEO reaffirmed focus on CNS innovation, with $778M cash balance for strategic M&A and pipeline expansion.
- **Pitolisant HD Feedback**: Early physician and payer interest in HD's differentiated efficacy and no-titration profile.
- **Fragile X Update**: Ongoing data review for ZYN002, with potential implications for 22q deletion syndrome trial reactivation.


Harmony Biosciences Holdings, Inc. (HRMY) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 2025 net revenue $200.5 million (+16% YoY), WAKIX on track for $1 billion+ in narcolepsy by 2030.
- **Pipeline Catalysts**: ZYN002 Phase III Fragile X readout Q3 2025, high-dose pitolisant Phase III Q4 2025, and orexin-2 first-in-human 2026.
- **Financial Strength**: $670 million cash, reaffirmed $820-$860 million 2025 guidance, and 126% YoY net income growth.
- **Strategic Expansion**: 8 assets across 13 programs, Circ Biosciences cell therapy collaboration, and 6 Phase III trials by year-end.

**【CEO Summary Section】**
- Q2 2025 net revenue of $200.5 million, up 16% YoY, driven by WAKIX's 400 new average patients quarterly.
- WAKIX on track for $1 billion+ annual revenue in narcolepsy by 2030, with 80,000 diagnosed patients in the U.S.
- Pipeline expansion includes ZYN002 Phase III for Fragile X (Q3 readout), high-dose and gastro-resistant pitolisant formulations, and epilepsy treatments (EPX100 in Phase III).
- Strategic collaboration with Circ Biosciences for cell therapies targeting refractory epilepsy and narcolepsy.

**【CFO Financial Commentary】**
- Non-GAAP net income $53.8 million ($0.92 EPS), up 126% YoY, with $79 million cash flow from operations.
- Reaffirmed 2025 revenue guidance of $820-$860 million, supported by WAKIX's 6-year growth streak.
- R&D investment for late-stage pipeline, including $15 million Circ collaboration charge and $29 million ZYN002 milestones.

**【Q&A Highlights】**
- ZYN002 Phase III RECONNECT study: 60-70% of Fragile X patients have full methylation; statistically powered to replicate 50% responder rate from Phase II.
- WAKIX resilience: 80% payer coverage, 4,000 REMS-enrolled prescribers, and 7,600 average patients Q2.
- Orexin-2 program (BP1.5205) shows best-in-class potency, targeting narcolepsy, idiopathic hypersomnia, and sleep inertia.
- Cell therapy collaboration: allogeneic, cryopreserved fibroblast-derived cells for epilepsy and narcolepsy, with IND expected in 2026.

Harmony Biosciences Holdings, Inc. (HRMY) Q2 2025 Earnings Call Transcript

- **Q1 2025 Revenue Growth**: $184.7 million (+20% YoY), reaffirming $820-$860 million full-year guidance.
- **Pipeline Momentum**: 6 Phase 3 trials by end-2025, including ZYN002 Fragile X readout Q3 2025.
- **Pitolisant HD Expansion**: Phase 3 trials Q4 2025, utility patents to 2044 for narcolepsy and hypersomnia.
- **Financial Strength**: $610 million cash, non-GAAP net income $60.4 million (+19% YoY).
- **Market Differentiation**: WAKIX as only non-scheduled narcolepsy treatment, no generic oxybate impact.

**【CEO Summary Section】**
- Q1 2025 net revenue reached $184.7 million, up 20% YoY, driven by WAKIX's sixth-year growth in narcolepsy.
- Reaffirmed $820-$860 million full-year guidance, targeting $1 billion+ in narcolepsy by 2030.
- Late-stage pipeline includes 8 assets across 13 programs, with 6 Phase 3 trials expected by end-2025.
- ZYN002 Phase 3 in Fragile X Syndrome (RECONNECT study) on track for Q3 2025 readout.
- Pitolisant HD (high-dose pitolisant) Phase 3 trials in narcolepsy and idiopathic hypersomnia set to begin Q4 2025.
- U.S.-based manufacturing for pitolisant HD and secondary U.S. WAKIX site mitigate supply chain risks.

**【CFO Financial Update】**
- Q1 2025 non-GAAP net income: $60.4 million ($1.03/diluted share), up 19% YoY.
- Cash balance: $610.2 million, supporting pipeline expansion and commercial growth.
- R&D expenses expected to rise with Phase 3 trials, including $29 million in 2025 milestones.
- Operating expenses: $96.6 million (up 28% YoY), driven by pipeline investments.

**【Pipeline Highlights】**
- **ZYN002 (Fragile X):** Phase 3 powered >90% for primary endpoint (social avoidance). Top-line data Q3 2025.
- **Pitolisant HD:** Optimized PK profile for fatigue and sleep inertia; PDUFA 2028, utility patents to 2044.
- **BP1.15205 (orexin agonist):** Preclinical data show >10x potency vs. competitors; IND filing mid-2025.
- **EPX-100 (epilepsy):** Phase 3 trials in Dravet and Lennox-Gastaut syndromes actively enrolling.

**【Commercial Strategy】**
- WAKIX maintains 80%+ payer coverage, no generic oxybate impact on demand.
- 7,300 patients on therapy at Q1 end, sequential growth driven by referrals and adherence.
- Pitolisant HD and GR formulations aim to extend franchise to 2044 via fatigue and GI comorbidity targeting.
- ZYN002 Phase 3 in 22q deletion syndrome set to begin 2025, addressing 80,000+ patients in U.S./EU.

Harmony Biosciences (HRMY)-6 May 25-2025 Q1 Earnings call transcript

- **Revenue Growth**: 23% YoY to $714.7 million, driven by WAKIX's narcolepsy sales.
- **Pipeline Potential**: $3+ billion from three rare neurology franchises.
- **2025 Catalysts**: ZYN002 Fragile X Phase 3 data (Q3), pitolisant HD trials (Q4), and epilepsy franchise expansion.
- **Financial Strength**: $576 million cash; 2025 net revenue guidance $820-860 million.
- **Strategic Moves**: Generic settlement extending exclusivity, orexin-2 receptor agonist IND in 2025.

**【CEO Summary Section】**
- 2024 revenue reached $714.7 million (23% YoY growth), driven by WAKIX's narcolepsy sales.
- Announced first generic settlement with Novagen Pharma, extending exclusivity to 2030.
- Pipeline poised for $3+ billion in net revenue, with three rare neurology franchises targeting $1-2 billion each.
- 2025 focus: ZYN002 Fragile X Phase 3 data, pitolisant HD trials, and epilepsy franchise expansion.

**【Chief Commercial Officer (Jeffrey Dierks)】**
- Q4 2024 net revenue: $201.3 million (20% YoY growth); full-year: $714.7 million (23% YoY).
- WAKIX average patients: 7,100 (300 QoQ increase); 50% penetration of 5,000+ prescribers.
- 2025 net revenue guidance: $820-860 million, targeting $1 billion+ in narcolepsy.
- Pitolisant HD and GR programs to extend franchise to mid-2040s.

**【Chief Medical Officer (Kumar Budur)】**
- ZYN002 Phase 3 (RECONNECT) targeting Fragile X social avoidance; top-line data Q3 2025.
- Pitolisant HD Phase 3 trials for narcolepsy (excessive sleepiness, fatigue) and IH (sleep inertia) starting Q4 2025.
- Orexin-2 receptor agonist (BP1.15205) in preclinical; IND submission mid-2025.
- Epilepsy franchise: EPX-100 Phase 3 trials in Dravet and LGS; top-line data 2026.

**【Chief Financial Officer (Sandip Kapadia)】**
- 2024 non-GAAP net income: $63 million ($1.08 EPS); cash: $576 million.
- 2025 R&D investments: $29 million in milestones for ZYN002 and ERECTIN.
- Operating expenses: $91.1 million Q4 (7% YoY growth) due to pipeline expansion.

**【Q&A Highlights】**
- **ZYN002 Trial Design**: RECONNECT focuses on complete methylation patients; open-label extension rollover rate >80%.
- **Pitolisant HD Success Factors**: Dose-response data, optimized PK, and IH-specific endpoints (sleep inertia).
- **Patent Strategy**: Vigorous defense of IP; Novagen settlement reinforces exclusivity.
- **Orexin Agonist Safety**: No evidence of Alzheimer's risk; preclinical data supports safety profile.

Actual	-0.14	0	0.13	0.24	-0.17	0.38	0.51	0.39	1.44	0.79	0.48	0.56	0.63	0.45	0.67	0.2	0.79	0.85	0.78	0.68	0.87	0.38
Forecast	-0.0467	0.0767	-0.0267	0.1767	0.28	0.3567	0.2929	0.45	0.1038	0.5843	0.4713	0.6088	0.6656	0.722	0.6043	-0.0017	0.6649	0.734	0.6065	0.7045	0.8111	0.9037
Surprise	-199.79%	-100.00%	+586.89%	+35.82%	-160.71%	+6.53%	+74.12%	-13.33%	+1287.28%	+35.20%	+1.85%	-8.02%	-5.35%	-37.67%	+10.87%	+11864.71%	+18.81%	+15.80%	+28.61%	-3.48%	+7.26%	-57.95%

HRMY

HRMY fundamentals

HRMY Q4 2025 Earnings

Earnings Call

You can ask Aime

HRMY

HRMY fundamentals

HRMY Q4 2025 Earnings

Earnings Call

HRMY Earnings Call Summary for Q4/20258:30 AM on Feb 24, 2026

HRMY Earnings Call Summary for Q3/20258:30 AM on Nov 4, 2025

HRMY Earnings Call Summary for Q2/20258:30 AM on Aug 5, 2025

HRMY Earnings Call Summary for Q1/20258:30 AM on May 6, 2025

HRMY Earnings Call Summary for Q4/20248:30 AM on Feb 25, 2025

You can ask Aime