US Market News
1月前
Harmony Biosciences Reports Q1 Financial Results and Confirms 2026 Net Revenue Guidance of Over $1 Billion; Reinforces 2026 Strategic PrioritiesMay 7, 2026 7:30 AM
Business Wire WAKIX® Net Revenue Grew 17% to $215.4 Million for First Quarter 2026; On Track for Full Year 2026 Net Revenues over $1 Billion Continue to Vigorously Protect WAKIX IP into 2030; Filed Suit Against AET Pharma/Sandoz Regarding Infringement of Amorphous Pitolisant Patent Lifecycle Management Advancing with Pitolisant GR on Track for NDA Filing 2Q26, Pitolisant HD Phase 3 Data in 2027, and Recently Acquired Novel Amorphous Form of Pitolisant to Pursue Broader CNS Indications Potential Best-in-Class Orexin-2 Agonist with BP-205; Phase 1 Clinical PK Data On Track for Mid-2026 Renewed Focus on Business Development Opportunities with Emphasis on Revenue Potential in the 2028 to 2032 Timeframe Expansion of the Leadership Team with the Addition of New COO and CFO to Support Scale and Next Phase of Growth Conference Call and Webcast Today at 8:30 a.m. ET Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q1 2026 revenue of $215.4 million, delivering 17% year-over-year growth for WAKIX®. Performance during the quarter reflected continued strong demand, offset by market access headwinds observed every Q1, which were more pronounced this year. This follows the strongest three consecutive quarters in franchise history, and the Company reinforced 2026 full year revenue guidance. The Company also outlined progress across four strategic priorities that it believes underpin long-term shareholder value. “Harmony is well positioned for long-term growth, and we are focused on four key pillars to drive value creation. First, protect the pitolisant franchise to ensure durability into the 2030s, supported by multi-layered intellectual property. Second, continued growth of the pitolisant franchise in an evolving market by advancing new formulations and differentiated approaches to solidify our leadership in the sleep/wake market. Third, drive value from our pipeline, led by BP-205, which has the potential to be a highly differentiated and best-in-class orexin-2 agonist across multiple indications. And fourth, a renewed emphasis on business development with a goal to transact on opportunities with revenue potential in the 2028–2032 timeframe,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “Executing on these four pillars positions us well to deliver innovative treatments for patients and generate long-term value for shareholders.” Key Pillars of Value Creation: Protect the Pitolisant Franchise ANDA Settlements: 3 additional ANDA settlements were reached in Q1, bringing the total settlements to 6 of the 7 ANDA filers Acquired New IP: Acquired exclusive license to an issued patent out to 2042 for a novel amorphous form of pitolisant, providing Harmony with new development opportunities in broader CNS patient populations Strong IP Protection/Exclusivity: Harmony’s pitolisant IP estate is multi-layered (formulations, methods of use, next-gen applications) and supports WAKIX exclusivity into 2030 (inclusive of 6-months of pediatric exclusivity), with potential protection of the franchise into the 2040s via additional patents/applications Filed Lawsuit: Harmony Biosciences and Novitium filed a patent infringement lawsuit in April against AET Pharma US and Sandoz, alleging infringement of patents covering an amorphous form of pitolisant hydrochloride Continued Pitolisant Franchise Growth in an Evolving Market First Quarter 2026 Net Product Revenue for WAKIX Net product revenue for the quarter ended March 31, 2026, was $215.4 million, compared to $184.7 million for the same period in 2025 Average number of patients in Q1 was 8,500; exited the quarter with 8,600 average patients On track to achieve >$1 Billion in narcolepsy net sales in 2026 Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026 Received FDA approval of pediatric cataplexy indication on February 13th Commercial team initiated full promotional efforts immediately upon approval Pitolisant in Prader-Willi syndrome (PWS) Phase 3 topline data readout expected in 2H 2026 Supports Pediatric Exclusivity for WAKIX: Fulfills a key regulatory requirement for six months of additional regulatory exclusivity, extending exclusivity to March 2030 Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s NDA submission on track for Q2 2026; anticipated PDUFA date in Q1 2027 Approximately 80-90% of patients with narcolepsy experience GI symptoms as part of their disease Pitolisant GR is designed with enteric coating meant to reduce the potential for GI side effects in patients prone to GI symptoms Enables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation Utility patents filed to extend franchise into the 2040s Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated labeling Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (IH) (ONSTRIDE 2) Topline data expected in 2027; anticipated PDUFA date in 2028 Enhanced formulation with optimized PK profile, enteric coating and higher dose to drive greater efficacy Differentiated labeling: fatigue in narcolepsy and sleep inertia in IH Utility patents filed to expand franchise into the 2040s Exploring novel amorphous form of pitolisant to pursue broader CNS indications This opportunity is based on the exclusive license to Novitium’s issued amorphous pitolisant patent with protection until 2042 Current efforts focused on formulation optimization and new modes of delivery in preparation for Phase 1 PK study Drive Value from our Robust Pipeline Orexin-2 receptor agonist BP-205 (BP1.15205) BP-205 is Harmony’s lead OX2R agonist, built upon a novel chemical scaffold, with the potential for best-in-class therapy: The most potent OX2R agonist currently in clinical development The high potency enables the potential for significantly lower dosing than current OX2R assets under development Potential for once-daily dosing across NT1, NT2 and IH (supported by favorable preclinical PK profile) High selectivity for OX2R over OX1R and across 150 other receptors of interest Potential for favorable safety/tolerability profile (supported by preclinical safety pharmacology and toxicology data) Phase 1 SAD/MAD clinical study ongoing in Europe; on track for clinical PK, safety, and tolerability data from SAD phase in mid-2026 U.S. IND submission planned for mid-2026 Plan to initiate Phase 1b study in sleep-deprived healthy volunteers in 2H 2026 Exploring use outside of sleep/wake, including cognition, ADHD, mood, and fatigue EPX-100 (clemizole hydrochloride) One of the most advanced development programs in the 5HT2 (serotonin) agonist class Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies: Lennox-Gastaut syndrome (LGS) – the LIGHTHOUSE Study Dravet syndrome (DS) – the ARGUS Study Encore safety and effectiveness data from the open-label extension study in DS that showed clinically meaningful reduction in seizures and a favorable safety and tolerability profile was presented at AAN meeting in April 2026 Both trials are currently enrolling in North America, Europe, China and India Topline data anticipated in 1H 2027 and potential PDUFA date in 2028 Renewed Emphasis on Business Development Focused on opportunities with revenue potential in 2028–2032 Prioritizing assets in Phase 3, in-registration, or on-market Therapeutic areas of interest include Sleep/Wake, Epilepsy, Rare/Orphan CNS, and CNS adjacencies beyond rare disease Supported by a strong balance sheet and clear conviction to execute on strategic business development opportunities Strong liquidity position of $870.5 million in cash, cash equivalents, and investments as of March 31, 2026 Personnel Updates Appointed Peter Anastasiou as Chief Operating Officer (effective April 2, 2026) and Glenn Reicin as Chief Financial Officer (effective April 14, 2026), supporting continued focus on strategic growth First Quarter 2026 Financial Results Harmony Biosciences reported net product revenue of $215.4 million for the quarter ended March 31, 2026, compared to $184.7 million for the same period in 2025, representing 17% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.) and the product's broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time. Cost of product sold was $44.5 million in the first quarter of 2026, or 20.7% as a percentage of net product revenue, as compared to $32.0 million, or 17.3%, for the same quarter in 2025, representing a 39% increase. The increase in cost of product sold as a percentage of net product revenue was driven by new royalties related to the Novitium license agreement. Net income for the quarter was $32.5 million, or $0.55 per diluted share, compared to $45.6 million, or $0.78 per diluted share, in Q1 2025. The decline in earnings was entirely driven by the licensing agreements entered into during Q1 2026. Harmony’s operating expenses include the following: Research and Development expenses were $69.4 million in the first quarter of 2026, as compared to $34.5 million for the same quarter in 2025, representing a 101% increase; the increase was primarily driven by $32.0 million in expenses related to up-front payments for license agreements that were entered into during Q1 2026, providing new development opportunities, which had an after-tax impact to earnings of $0.45 per share Sales and Marketing expenses were $31.7 million in the first quarter of 2026, as compared to $30.7 million for the same quarter in 2025, representing a 3% increase General and Administrative expenses were $32.5 million in the first quarter of 2026, as compared to $31.2 million for the same quarter in 2025, representing a 4% increase Total Operating Expenses were $133.6 million in the first quarter of 2026, as compared to $96.5 million for the same quarter in 2025, representing a 38% increase As of March 31, 2026, Harmony had cash, cash equivalents and investments of $870.5 million, compared to $882.5 million as of December 31, 2025. The reduction was primarily due to up-front payments for license agreements and payment of ANDA settlements during Q1 2026. 2026 Net Product Revenue Guidance Reiterated 2026 WAKIX Net Revenue Guidance of $1.0 Billion – $1.04 Billion Conference Call Today at 8:30 a.m. ET Harmony is hosting its first quarter 2026 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern time. The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial: (888) 596-4144 (domestic) or (646) 968-2525 (international, alternate); reference passcode 6626692. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2026 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; plans to submit an NDA for Pitolisant GR; plans to submit an IND for BP-205; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100, Pitolisant GT and BP-205; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 24, 2026 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(In thousands, except share and per share data) Three Months Ended March 31, 2026 2025 Net product revenue $ 215,387 $ 184,733 Cost of product sold 44,512 31,994 Gross profit 170,875 152,739 Operating expenses: Research and development 69,383 34,540 Sales and marketing 31,694 30,711 General and administrative 32,507 31,243 Total operating expenses 133,584 96,494 Operating income 37,291 56,245 Other (expense) income, net (127 ) (276 ) Interest expense (3,234 ) (3,836 ) Interest income 5,757 5,044 Income before income taxes 39,687 57,177 Income tax expense (7,199 ) (11,617 ) Net income $ 32,488 $ 45,560 Unrealized (loss) income on investments (759 ) 179 Comprehensive income $ 31,729 $ 45,739 EARNINGS PER SHARE: Basic $ 0.56 $ 0.79 Diluted $ 0.55 $ 0.78 Weighted average number of shares of common stock - basic 57,819,060 57,309,938 Weighted average number of shares of common stock - diluted 58,776,297 58,524,566 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data) March 31, December 31, 2026 2025 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 589,398 $ 752,502 Investments, short-term 51,520 22,838 Trade receivables, net 108,222 96,787 Inventory, net 5,281 5,357 Prepaid expenses 16,801 16,014 Other current assets 7,595 13,516 Total current assets 778,817 907,014 NONCURRENT ASSETS: Investments, long-term 229,555 107,127 Intangible assets, net 83,457 89,418 Deferred tax asset 153,562 149,699 Other noncurrent assets 26,433 18,373 Total noncurrent assets 493,007 364,617 TOTAL ASSETS $ 1,271,824 $ 1,271,631 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $ 28,600 $ 17,693 Accrued compensation 6,726 18,443 Accrued expenses 150,107 191,039 Current portion of long-term debt 20,000 20,000 Other current liabilities 11,907 4,957 Total current liabilities 217,340 252,132 NONCURRENT LIABILITIES: Long-term debt, net 138,814 143,663 Other noncurrent liabilities 5,321 5,618 Total noncurrent liabilities 144,135 149,281 TOTAL LIABILITIES 361,475 401,413 COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS’ EQUITY: Common stock—$0.00001 par value; 500,000,000 shares authorized at March 31, 2026, and December 31, 2025, respectively; 57,867,389 and 57,726,170 shares issued and outstanding at March 31, 2026, and December 31, 2025, respectively 1 1 Additional paid in capital 717,370 708,968 Accumulated other comprehensive (loss) income (413 ) 346 Retained earnings 193,391 160,903 TOTAL STOCKHOLDERS’ EQUITY 910,349 870,218 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,271,824 $ 1,271,631 View source version on businesswire.com: https://www.businesswire.com/news/home/20260507035953/en/ Harmony Biosciences Investor Contact:
Brennan Doyle
484-566-3685
bdoyle@harmonybiosciences.com Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com Original: Harmony Biosciences Reports Q1 Financial Results and Confirms 2026 Net Revenue Guidance of Over $1 Billion; Reinforces 2026 Strategic Priorities
US Market News
2月前
Harmony Biosciences Appoints Glenn Reicin as Chief Financial OfficerApril 14, 2026 8:05 AM
Business Wire
COMPANY REITERATES ITS 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION IN WAKIX SALES
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the appointment of Glenn Reicin as Chief Financial Officer, effective immediately, supporting Harmony’s continued focus on strategic growth, financial strength, and long-term value creation. Harmony is also reiterating its 2026 net product revenue guidance of $1.0 to $1.04 billion.
Mr. Reicin is a seasoned biopharmaceutical executive with extensive experience across publicly traded and privately held companies, guiding them through key growth inflection points. With his experience as a sell-side analyst, investor and biotech CFO, he brings a strong track record of success in strategic planning, capital markets, fundraising, and financial reporting. Most recently, Mr. Reicin served as Chief Financial Officer at Eccogene, where he led the buildout of the company’s financial infrastructure to make the company IPO ready and support its long-term growth strategy.
Previously, Mr. Reicin served as Chief Financial Officer and Chief Operating Officer at Alladapt Immunotherapeutics, where he oversaw fundraising efforts, the buildout of strong clinical and manufacturing operations, and led the company through multiple financing initiatives. He started his career as a research analyst at Morgan Stanley where he was a top-ranked analyst for 15 consecutive years. He also spent four years as the Managing Director of Skyline Ventures. Throughout his career, Mr. Reicin has demonstrated a strong aptitude for strategic planning and capital allocation and has positioned organizations for sustained growth and value creation.
As Chief Financial Officer and a member of the Executive Team, Mr. Reicin will play a pivotal role in helping to drive the execution of Harmony’s key strategic priorities. He will oversee Harmony’s finance organization, including financial planning and analysis, accounting, treasury, investor relations, and risk management.
“I am excited to welcome Glenn to Harmony and his appointment comes at a pivotal moment in the evolution of the company, as we look to leverage our strong balance sheet to grow the enterprise and drive long-term value creation,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “Glenn’s experience leading organizations through periods of growth and transformation will be instrumental as we look to execute on our strategy with a focus on bringing innovative treatments to patients with unmet medical needs and creating even greater value for our shareholders.”
“I also want to thank Sandip Kapadia for his leadership and many contributions to Harmony,” Dayno continued. “Sandip has been a trusted partner during an important period for the company, helping to strengthen our financial profile and support our growth strategy. We are grateful for his service and wish him continued success throughout his career.”
“I am excited to join Harmony and see significant potential ahead,” said Mr. Reicin. “Harmony’s strong leadership team, along with its solid financial profile, outstanding commercial operations, and keen focus on building out its pipeline, present an exciting opportunity for continued growth and significant shareholder value creation.”
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260414988782/en/
Harmony Biosciences Investor Contact:
Brennan Doyle
484-566-3685
bdoyle@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
Original: Harmony Biosciences Appoints Glenn Reicin as Chief Financial Officer
US Market News
4月前
Harmony Biosciences Reports Strong 2025 Financial Results and Reiterates 2026 Net Revenue Guidance of Over $1 BillionFebruary 24, 2026 7:30 AM
Business Wire
WAKIX 2025 Net Revenue of $868.5 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy
Recently Completed Settlements with 3 Additional Generic Filers Toward Goal of Securing WAKIX Franchise
Pitolisant GR NDA Submission on Track for Q2 2026; Extends the Pitolisant Franchise into the 2040s
Exploring New Opportunities to Broaden the Pitolisant Franchise Beyond Orphan/Rare into Larger CNS Indications
Potential Best-In-Class Orexin-2 Agonist (BP1.15205) Phase 1 Trial Ongoing; Clinical Data Expected in Mid-2026
Conference Call and Webcast Today at 8:30 a.m. ET
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings with reported revenue of $243.8 million for Q4 2025, representing 21% year-over-year revenue growth for WAKIX®. For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength as evidenced by six consecutive years of revenue growth and profitability. The company enters the year with significant momentum, reinforcing its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.
“WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026, reflecting the strength and durability of the pitolisant franchise. Based on this commercial success and our strong momentum, we see even greater opportunity for pitolisant going forward,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “The next-generation formulations of pitolisant are designed to grow our leadership in sleep-wake, extend the lifecycle of pitolisant into the 2040’s, expand into additional orphan/rare indications, and now broaden our reach beyond orphan/rare into larger CNS patient populations. Our robust late-stage pipeline, including five ongoing Phase 3 registrational trials across five distinct CNS indications, positions Harmony for multiple near-term catalysts and meaningful long-term value creation.”
Fourth Quarter and Full Year 2025 Net Product Revenue for WAKIX
Net product revenue for the quarter ended December 31, 2025, was $243.8 million, compared to $201.3 million for the same period in 2024
Average number of patients on WAKIX increased by ~400 patients to ~8,500 patients in Q4 2025; representing the third consecutive quarter of ~400+ patient adds
Net product revenue for the full year ended December 31, 2025, was $868.5 million, compared to $714.7 million for the full year ended December 31, 2024, representing ~22% growth year on year
Pitolisant Franchise Strategy
WAKIX: On track to achieve blockbuster status in narcolepsy
Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026
Received FDA approval of pediatric cataplexy indication on February 13th
Commercial team triggered full promotional efforts immediately upon approval
Pitolisant in Prader-Willi syndrome (PWS)
Phase 3 topline data readout in 2H 2026
Supports Pediatric Exclusivity for WAKIX: Fulfills the last regulatory requirement for six months of additional regulatory exclusivity on top of the longest patent for WAKIX
ANDA Litigation Update
Recently completed settlements with 3 additional generic filers bringing the total to six of the seven ANDA filers
The settling parties will receive licenses to launch their generic products no earlier than March 2030 if Harmony is granted pediatric exclusivity, which it is on track to obtain
Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s
NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027
Approximately 80-90% of patients with narcolepsy experience GI symptoms; pitolisant GR is designed to minimize the worsening of these symptoms
Ability to initiate treatment at therapeutic dose with no titration
Utility patents filed to extend franchise into the 2040s
Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated rare indications
Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2)
Topline data in 2027; anticipated PDUFA date in 2028
Enhanced formulation with optimized PK profile, GR coating and higher dose to drive greater efficacy
Differentiated indications: fatigue in narcolepsy and sleep inertia in IH
Utility patents filed to expand franchise into the 2040s
Exploring new pitolisant formulation to pursue broader indications in CNS patient populations in which fatigue is a prominent symptom
Mechanism-based approach supported by clinical data for pitolisant in fatigue
Currently planning MS fatigue as the lead indication; follow on indications under consideration include fatigue in Parkinson's disease and post-stroke fatigue
Current efforts focused on formulation optimization and new modes of delivery towards a phase 1 PK study
Licensed IP with patent protection until 2042
Robust Pipeline
Orexin-2 receptor agonist (BP1.15205)
Phase 1 clinical study ongoing; anticipates clinical PK data in mid-2026
Potential best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity, safety and efficacy data, and potential for once-a-day dosing
EPX-100 (clemizole hydrochloride)
One of the most advanced development programs in the 5HT2 (serotonin) agonist class
Enrollment ongoing for Phase 3 registrational trial in Dravet syndrome (ARGUS Study) with topline data anticipated in 1H 2027
Safety and effectiveness data from the open-label extension study in DS was presented at AES meeting in December 2025
Enrollment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 1H 2027
Fourth Quarter 2025 Financial Results
Harmony Biosciences reported net product revenue of $243.8 million for the quarter ended December 31, 2025, compared to $201.3 million for the same period in 2024, representing 22% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.) and the product's broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time.
On a GAAP basis, net income for the quarter was $22.5 million, or $0.38 per diluted share, compared to $49.5 million, or $0.85 per diluted share, in Q4 2024. Non-GAAP adjusted net income, which we believe better reflects our core business performance, was $33.4 million ($0.57 per diluted share) for the fourth quarter of 2025 versus $64.2 million ($1.10 per diluted share) for the comparable 2024 period.
Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
Harmony’s operating expenses include the following:
Research and Development expenses were $49.9 million in the fourth quarter of 2025, as compared to $34.7 million for the same quarter in 2024, representing a 44% increase;
Sales and Marketing expenses were $29.2 million in the fourth quarter of 2025, as compared to $27.6 million for the same quarter in 2024, representing a 6% increase;
General and Administrative expenses were $57.6 million in the fourth quarter of 2025, as compared to $28.9 million for the same quarter in 2024, representing a 99% increase; and
Total Operating Expenses were $136.7 million in the fourth quarter of 2025, as compared to $91.1 million for the same quarter in 2024, representing a 50% increase.
Full Year 2025 Financial Results
Net product revenues for the year ended December 31, 2025, were $868.5 million, compared to $714.7 million for the same period in 2024. The 22% growth versus the same period in 2024 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the U.S.) and the broad clinical utility of WAKIX across the approximately 9,000 HCPs that we call on (about 5,000 of whom do not participate in an oxybate REMS program).
GAAP net income for the year ended December 31, 2025, was $158.7 million, or $2.71 earnings per diluted share, compared to GAAP net income of $145.6 million, or $2.51 earnings per diluted share, for the same period in 2024. Non-GAAP adjusted net income was $211.0 million, or $3.60 earnings per diluted share, for the year ended December 31, 2025, compared to Non-GAAP adjusted net income of $196.7 million, or $3.40 per diluted share, for the same period in 2024.
Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
Harmony’s operating expenses included the following:
Research and Development expenses were $189.6 million for the year ended December 31, 2025, as compared to $145.8 million for the prior year, representing a 30% increase.
Sales and Marketing expenses were $119.5 million for the year ended December 31, 2025, as compared to $110.9 million for the prior year, representing a 8% increase;
General and Administrative expenses were $152.5 million for the year ended December 31, 2025, as compared to $110.4 million for the prior year, representing a 38% increase; and
Total Operating Expenses were $461.6 million for the year ended December 31, 2025, as compared to $367.1 million for the prior year, representing a 26% increase.
As of December 31, 2025, Harmony had cash, cash equivalents and investments of $882.5 million, compared to $576.1 million as of December 31, 2024.
2026 Net Product Revenue Guidance
Reiterated 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04B
Conference Call Today at 8:30 a.m. ET
We are hosting our fourth quarter 2025 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern time. The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/.
To participate in the live call by phone, dial 800-274-8461 (domestic) or 203-518-9814 (international), and reference passcode HRMYQ425.
Non-GAAP Financial Measures
In addition to our GAAP results, we present certain Non-GAAP measures including Non-GAAP adjusted net income and Non-GAAP adjusted net income per share, which we believe provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate Non-GAAP adjusted net income and Non-GAAP adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. We use these Non-GAAP measurements as an aid in monitoring our financial performance from quarter-to-quarter and year-to-year and benchmarking against comparable companies. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our Non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our Non-GAAP financial measures.
About WAKIX® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.
Indications and Usage
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.
Important Safety Information
Contraindications
WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment.
Warnings and Precautions
WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.
The risk of QT prolongation may be greater in patients with higher concentrations of pitolisant (e.g., patients with hepatic or renal impairment). Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD).
Adverse Reactions
In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program.
Drug Interactions
Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half.
Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required.
H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists.
WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment.
Use in Specific Populations
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.
The safety and effectiveness of WAKIX have not been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients less than 6 years of age with narcolepsy.
WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.
WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR
US Market News
4月前
Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric NarcolepsyFebruary 17, 2026 8:05 AM
Business Wire
Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy.
“We are excited to achieve this important milestone for pediatric narcolepsy patients who experience cataplexy,” said Kumar Budur, M.D., M.S., Chief Medical and Scientific Officer of Harmony Biosciences. “With this approval, clinicians now have the option to prescribe WAKIX to treat excessive daytime sleepiness, cataplexy, or both, in patients 6 years and older with narcolepsy.”
WAKIX was approved by the FDA in August 2019 for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy, with approval expanded to include cataplexy in adult patients in October 2020. The FDA approved WAKIX for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy in June 2024.
“WAKIX is now the first-and-only FDA-approved treatment option for both pediatric and adult narcolepsy patients with or without cataplexy that is not scheduled as a controlled substance, an important distinction that supports its clinical utility,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “We continue to advance our efforts toward obtaining pediatric exclusivity for WAKIX, which, if granted, would add an additional six months of regulatory exclusivity for this growing franchise. Our sights are now set on further growing, extending and expanding the value of pitolisant through additional indications with our next-generation formulations, which have utility patents filed out to 2044.”
About WAKIX® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.
Indications and Usage
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.
Important Safety Information
Contraindications
WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment.
Warnings and Precautions
WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.
The risk of QT prolongation may be greater in patients with higher concentrations of pitolisant (e.g., patients with hepatic or renal impairment). Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD).
Adverse Reactions
In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program.
Drug Interactions
Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half.
Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required.
H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists.
WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment.
Use in Specific Populations
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.
The safety and effectiveness of WAKIX have not been established for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients less than 6 years of age with narcolepsy.
WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.
WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR
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