Harmony Biosciences Holdings, Inc 8-K, filed Nov 4, 2026
Harmony Biosciences Holdings, Inc. (HRMY)
About this 8-K
Harmony Biosciences Holdings, Inc filed this 8-K on November 4, 2026.
Harmony Biosciences reported WAKIX net revenue of $268.9 million for the quarter ended September 30, 2026 and reiterated 2026 guidance of $1.0 billion to $1.04 billion. BP-205 preliminary results were favorable, and Peter Anastasiou will become CEO on January 1, 2027. AI summary
Items reported
- Item 2.02: Financial results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 4, 2026, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On November 4, 2026, the Company posted an investor presentation to its website at ttps://ir.harmonybiosciences.com (the “Investor Presentation”). A copy of the Investor Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others.
The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Investor Presentation, although it may do so from time to time. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. In addition, the exhibit furnished herewith contains statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibit. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information in the Investor Presentation that is required to be disclosed solely by reason of Regulation FD.
This Current Report on Form 8-K and its contents (including Exhibits 99.1 and 99.2) are furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form 8-K constitute “forward-looking statements” within the meaning of the federal securities laws. These statements are based on management’s current opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results. These forward looking statements are only predictions, not historical fact, and involve certain risks and uncertainties, as well as assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, it is very difficult to predict the impact of known factors, and, of course, it is impossible to anticipate all factors that could affect actual results. There are many risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein including the risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (“SEC,”) on February 24, 2026, as well as other factors described from time to time in the Company’s filings with the SEC. Such forward-looking statements are made only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update or revise any forward-looking statement because of new information, future events or otherwise, except as otherwise required by law. If it does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit | | |
No. | | Description |
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99.1* | | Press release issued by the Company, dated November 4, 2026. |
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99.2* | | |
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104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* | This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| HARMONY BIOSCIENCES HOLDINGS, INC. | |
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Date: November 4, 2026 | By: | /s/ Stephen Mollichella |
| | Stephen Mollichella |
| | Senior Vice President, Controller and Interim Principal Financial Officer |
Harmony Biosciences Reports Q3 Financial Results
On Track to Achieve More Than $1 Billion WAKIX Net
Revenue and Announces Strong Multiple-Ascending Dose Data for Its Orexin Agonist BP-205, Supporting Potential Best-in-Class Profile
WAKIX ® Net Revenue in Q3 of $269 Million; Driven by Strong Demand with 400 Net Patient Adds in the Quarter; Reiterates Full Year Guidance of $1.0B to $1.04B
Repeated Once-Daily Dosing with BP-205 in Multiple-Ascending Dose Study Reinforces Favorable Safety, Tolerability and Pharmacokinetic Profile Observed in Single-Ascending Dose Study
Results from Phase 1b Study in Sleep-Deprived Healthy Volunteers for BP-205 Remain on Track for Q1 2027; Phase 2 Studies in Multiple CNS Indications Expected to Initiate by Mid-2027
Pitolisant GR NDA Under FDA Review, PDUFA Date April 1, 2027; Pitolisant HD Phase 3 Topline Data in 2027, Target PDUFA Date in 2028
Multi-Layered IP Strategy Across Active Legal Proceedings Reinforces Confidence in WAKIX Exclusivity to March 2030
Peter Anastasiou to Succeed Jeffrey Dayno, MD, as President and Chief Executive Officer Effective January 1, 2027
Conference Call and Webcast Today at 8:30 a.m. ET
PLYMOUTH MEETING, Pa., November 4, 2026 /Globe Newswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported third quarter 2026 financial results and preliminary data from its multiple-ascending dose (MAD) clinical study for its potential best-in-class orexin agonist BP-205. WAKIX® (pitolisant) delivered third quarter net revenue of $269 million, driven by strong demand of 400 net patient adds, and the Company remains on track to achieve full-year WAKIX net revenue guidance of $1.0 billion to $1.04 billion.
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The encouraging preliminary results from the MAD study with BP-205, following 14 days of repeated once-daily dosing, reinforce the favorable safety, tolerability and pharmacokinetic profile observed in the single-ascending dose (SAD) portion of the study. No liver or visual adverse events were reported, and no clinically significant cardiovascular events or EKG abnormalities were recorded. Harmony remains on track to report Phase 1b data in sleep-deprived healthy volunteers in the first quarter of 2027, followed by the initiation of Phase 2 studies across multiple CNS indications by mid-2027.
Additionally, as announced on October 12, 2026, Peter Anastasiou, Senior Executive Vice President and Chief Operating Officer, will become President and Chief Executive Officer effective January 1, 2027, succeeding Jeffrey Dayno, MD, who will retire on December 31, 2026. This planned leadership transition does not change Harmony's previously communicated strategic priorities or the expected timing of key commercial and pipeline milestones.
“As I prepare to transition the President and CEO role to Peter on January 1, I believe Harmony is operating from a position of strength, with a durable and growing WAKIX franchise, the financial flexibility to invest in innovation, conviction to pursue strategic business development opportunities, and a pipeline led by BP-205 that has the potential to generate significant long-term value,” said Jeffrey Dayno, MD, President and Chief Executive Officer of Harmony Biosciences. “I am proud of the talented team and passionate organization we have built, which position Harmony for continued success in delivering innovative treatments to patients and sustained value for our shareholders.”
Key Drivers of Value Creation
Continued WAKIX Growth in an Evolving Market
Third Quarter 2026 Net Product Revenue for WAKIX
| ● | WAKIX net revenue for the quarter ended September 30, 2026, was $268.9 million, driven by strong patient demand: |
| o | Estimated average number of patients grew by 400 to 9,350 in Q3, continuing strong recent performance with 5 of the last 6 quarters achieving more than 400 patient additions |
| o | Executed expansion of field sales, remote sales, field reimbursement and patient outreach teams with all roles hired, trained and fully deployed in Q2 |
| ● | Growth continues to be demand driven: WAKIX is the only non-scheduled treatment option for excessive daytime sleepiness and cataplexy in adult and pediatric patients |
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| with narcolepsy type 1 and 2, supported by more than seven years of clinical experience and coverage for more than 80% of covered lives |
| ● | Significant market opportunity remains: approximately 170,000 people in the U.S. are living with narcolepsy, fewer than 50% are diagnosed, and brand penetration is approximately 20% |
On Track to Achieve 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 Billion
Advance Robust, Self-Funded Pipeline
BP-205 (Orexin-2 receptor agonist)
BP-205 MAD Study Design and Preliminary Results
| ● | 14-day double-blind, randomized, placebo-controlled study that evaluated once-daily doses of BP-205 at 0.1 mg, 0.6 mg, 1 mg, and 3 mg across six cohorts (4 male and 2 female); a total of 94 healthy volunteers participated in this study |
| ● | BP-205 was rapidly absorbed, with a mean T(max) of approximately 60 minutes (range 30 to 90 minutes) supportive of the potential for rapid onset of efficacy |
| ● | The mean effective half-life (T1/2) after 14-day repeat dosing was observed to be approximately 29 hours; no clinically meaningful change compared to the half-life in the SAD study and supportive of once-daily dosing |
| ● | BP-205 was generally well tolerated across all doses evaluated: headache was the most common adverse event occurring in approximately 25% of participants |
| ● | On-target adverse events of insomnia were reported in less than 20% of participants at all doses evaluated, were mild in severity and did not lead to discontinuation |
| ● | On-target adverse events of urinary frequency and urgency were reported in less than 20% of participants at the 1mg and 3mg doses only; these events were mild in severity and did not lead to discontinuation |
| ● | No liver or visual adverse events were reported, and no clinically significant cardiovascular events or EKG abnormalities were recorded |
| ● | There were no serious or severe adverse events |
| ● | The complete MAD study results will be presented at an upcoming medical meeting |
| ● | Next steps in BP-205 development: |
| o | Phase 1b study in sleep-deprived healthy volunteers initiated in Q3 in the US; data expected in Q1 2027 |
| o | Expect to initiate Phase 2 studies to evaluate multiple CNS indications by mid-2027 |
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| ● | Poster presented by Bioprojet at the SLEEP EU 2026 meeting showed an in-vivo synergistic effect of orexin and histamine on wakefulness in a narcoleptic mouse model; this suggests concomitant use of an orexin-2 agonist and pitolisant as a potential therapeutic approach for patients with central disorders of hypersomnolence |
| ● | BP-205, Harmony’s investigational OX2R agonist, was discovered by Teijin Pharma and is being developed in partnership with Bioprojet |
Pitolisant GR (gastro-resistant) Tablets: On track to launch in 1H 2027
| ● | NDA accepted by the FDA with PDUFA date of April 1, 2027 |
| o | Enables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation |
| ● | Utility patents filed to extend pitolisant franchise into the 2040s |
Pitolisant HD (high dose): Opportunity to extend the pitolisant franchise with differentiated labeling
| ● | Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (IH) (ONSTRIDE 2): |
| o | Topline data expected in 2027 and anticipated PDUFA date in 2028 |
| o | Enhanced formulation with optimized PK profile, enteric coating and higher dose to drive greater efficacy |
| o | Pursuing differentiated labeling: fatigue in narcolepsy and sleep inertia in IH |
| ● | Utility patents filed to extend pitolisant franchise into the 2040s |
WAKIX (pitolisant): Phase 3 trial in Prader-Willi syndrome (PWS) (TEMPO)
| ● | Topline data expected in mid-2027 and anticipated PDUFA date in 2028 |
| ● | On track for pediatric exclusivity: completion of TEMPO study fulfills the second and last requirement agreed with FDA for WAKIX pediatric exclusivity, which would provide for an additional six months of regulatory exclusivity for WAKIX |
Exploring amorphous form of pitolisant to pursue broader CNS indications
| ● | This opportunity is based on our exclusive license to Novitium’s issued amorphous pitolisant patent with protection until 2042 |
| ● | Continued efforts to optimize formulation and new modes of delivery |
EPX-100 (clemizole hydrochloride)
| ● | Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies: |
| o | Lennox-Gastaut syndrome (LGS) – the LIGHTHOUSE Study |
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| o | Dravet syndrome (DS) – the ARGUS Study |
| ● | Topline data expected in mid-2027 and anticipated PDUFA date in 2028 |
| ● | Updated 18-month data from the open-label extension part of the ARGUS study to be presented at the American Epilepsy Society (AES) Annual Meeting in December 2026 |
Emphasis on Business Development
| ● | Two categories of opportunity: |
| o | Assets that can add near-term revenue in 2028 to 2032 to support our self-funded model |
| o | Innovative pipeline assets that drive long-term value creation (e.g., BP-205) |
| ● | Therapeutic areas of interest include Sleep Disorders, Epilepsy, Rare/Orphan CNS, and broader CNS indications |
| ● | Supported by a strong balance sheet and clear conviction to execute on strategic business development opportunities |
Protect the Pitolisant Franchise
| ● | Multi-layered strategy: Harmony is asserting its pitolisant IP in active legal proceedings, with each case covering different components of our multi-layered IP strategy: |
| o | Polymorph and method of use ('197 and '947): The bench trial in the AET ANDA litigation closing arguments were held on October 22, 2026; ruling is expected around the time of the 30-month stay (February 2027) |
| o | Amorphous form ('920): Harmony Biosciences and Novitium filed a lawsuit alleging patent infringement in April against AET Pharma US and its marketing partner Sandoz; the licensed Novitium patent provides protection to 2042. A scheduling conference was held on October 21. The amorphous '920 patent trial has not yet been scheduled, but would be expected to be scheduled for some time in 2029. |
| o | Yesterday, November 3, the judge scheduled a preliminary injunction hearing on January 26, 2027, with an expected decision by February 14, 2027 when the 30-month stay expires. This schedule is identical to the preliminary injunction schedule Harmony proposed to the judge on October 26 |
| ● | In Q1 this year, we obtained the exclusive rights to a patent covering methods of making amorphous pitolisant hydrochloride from our licensee MSN Labs. That patent was issued by the PTO in Q3. The patent strengthens our patent portfolio and protects our development efforts for a new amorphous pitolisant hydrochloride product |
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| ● | Together with settlements with 6 of the 7 ANDA filers, these actions reinforce Harmony's confidence in WAKIX exclusivity to March 2030 (inclusive of 6 months of pediatric exclusivity) |
Third Quarter 2026 Financial Results
Harmony Biosciences reported WAKIX net revenue of $268.9 million for the quarter ended September 30, 2026, compared to $239.5 million for the quarter ended September 30, 2025, representing a 12% increase over the same period. This performance reflects continued strong demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.), disciplined commercial execution across the franchise and the product's broad clinical utility. Based on our results for the first nine months of 2026, WAKIX remains on track to achieve full-year net revenue of $1.0 billion to $1.04 billion.
Cost of product sold was $80.7 million in the third quarter of 2026, or 30% as a percentage of WAKIX net revenue, as compared to $59.7 million, or 25%, for the same quarter in 2025, representing a 35% increase. The increase in cost of product sold as a percentage of net product revenue was primarily driven by new royalties related to the Novitium license agreement.
Net income for the third quarter was $48.2 million, or $0.81 per diluted share, compared to $50.9 million, or $0.87 per diluted share, for the same quarter in 2025. The decline in earnings was primarily driven by an increase in milestone charges and the new MSN royalty charges during the third quarter of 2026 as compared to the same quarter in 2025.
Harmony’s operating expenses include the following:
| ● | Research and Development expenses were $71.7 million in the third quarter of 2026, as compared to $55.0 million for the same quarter in 2025, representing a 30% increase; this was primarily driven by a $25.0 million charge related to a milestone achieved for the MSN license agreement, partially offset by a $15.0 million charge related to a clinical milestone achieved for ZYN002 in the prior year period; |
| ● | Sales and Marketing expenses were $34.7 million in the third quarter of 2026, as compared to $29.5 million for the same quarter in 2025, representing an 18% increase, primarily driven by the expansion of our field-based teams; |
| ● | General and Administrative expenses were $27.7 million in the third quarter of 2026, as compared to $29.8 million for the same quarter in 2025, representing a 7% decrease; primarily driven by a decline in stock-based compensation expense; and |
| ● | Total Operating expenses were $134.0 million in the third quarter of 2026, as compared to $114.3 million for the same quarter in 2025, representing a 17% increase. |
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As of September 30, 2026, Harmony had cash, cash equivalents and investments of $1,051.6 million, compared to $882.5 million as of December 31, 2025.
Capital Allocation Priorities
| ● | Invest in R&D pipeline, especially BP-205 development plan |
| ● | Success-based R&D milestone payments |
| ● | Strategic business development to expand pipeline and diversify commercial portfolio |
2026 WAKIX Net Revenue Guidance
Reiterated full year guidance of $1.0 billion to $1.04 billion.
Conference Call Today at 8:30 a.m. ET
Harmony is hosting its third 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 call, please dial 800-347-6865 (domestic) or 203-518-9757 (international or alternate), and reference passcode HRMYQ326.
About Harmony Biosciences
Harmony Biosciences is developing and commercializing innovative medicines for both rare and broad CNS disorders, and we are becoming an enduring leader in neuroscience. Our first medicine, WAKIX® (pitolisant), is the first and only FDA-approved non-scheduled treatment for excessive daytime sleepiness or cataplexy in patients 6 years of age and older with narcolepsy. Its launch ranks among the most successful in the history of orphan drugs. Building on our success and profitability, we are continuing to advance our novel clinical-stage pipeline, led by BP-205, an investigational orexin-2 receptor agonist with best-in-class potential across a broad range of CNS disorders. With a strong balance sheet, we have the capacity and conviction to pursue strategic business development opportunities. Harmony is guided by an unwavering commitment to patients and driven to create long-term value for shareholders. For more information, 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, the potential profile of our product candidates, our planned and ongoing clinical trials and expected timing of data readouts, anticipated regulatory milestones
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and product launches, our future results of operations and financial position, our intellectual property, pending litigation and regulatory exclusivity, our planned leadership transition, market opportunity, business strategy, business development, products, prospective products, product approvals, and the plans and objectives of management for future operations. 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 GR 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.
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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 September 30, | | Nine Months Ended September 30, | ||||||||
| | 2026 | | 2025 | | 2026 | | 2025 | ||||
Net product revenue | | $ | 268,917 | | $ | 239,455 | | $ | 745,584 | | $ | 624,677 |
Cost of product sold | |
| 80,686 | |
| 59,650 | |
| 188,396 | |
| 129,797 |
Gross profit | |
| 188,231 | |
| 179,805 | |
| 557,188 | |
| 494,880 |
Operating expenses: | |
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Research and development | |
| 71,663 | |
| 54,962 | |
| 187,642 | |
| 139,661 |
Sales and marketing | |
| 34,721 | |
| 29,549 | |
| 100,535 | |
| 90,333 |
General and administrative | |
| 27,650 | |
| 29,807 | |
| 88,207 | |
| 94,974 |
Total operating expenses | |
| 134,034 | |
| 114,318 | |
| 376,384 | |
| 324,968 |
Operating income | |
| 54,197 | |
| 65,487 | |
| 180,804 | |
| 169,912 |
Other expense, net | |
| (316) | |
| (106) | |
| (496) | |
| (575) |
Interest expense | | | (3,060) | | | (3,621) | | | (9,364) | |
| (11,103) |
Interest income | |
| 8,428 | |
| 5,730 | |
| 21,257 | |
| 16,070 |
Income before income taxes | |
| 59,249 | |
| 67,490 | |
| 192,201 | |
| 174,304 |
Income tax expense | |
| (11,053) | |
| (16,625) | |
| (36,086) | |
| (38,103) |
Net income | | $ | 48,196 | | $ | 50,865 | | $ | 156,115 | | $ | 136,201 |
Unrealized (loss) income on investments | |
| (1,213) | |
| 118 | |
| (2,286) | |
| 291 |
Comprehensive income | | $ | 46,983 | | $ | 50,983 | | $ | 153,829 | | $ | 136,492 |
EARNINGS PER SHARE: | |
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Basic | | $ | 0.83 | | $ | 0.88 | | $ | 2.68 | | $ | 2.36 |
Diluted | | $ | 0.81 | | $ | 0.87 | | $ | 2.63 | | $ | 2.32 |
Weighted average number of shares of common stock - basic | |
| 58,409,880 | |
| 57,550,902 | |
| 58,271,509 | |
| 57,655,272 |
Weighted average number of shares of common stock - diluted | |
| 59,679,319 | |
| 58,717,910 | |
| 59,272,602 | |
| 58,738,361 |
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| | September 30, | | December 31, | ||
| | 2026 | | 2025 | ||
ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents | | $ | 647,099 | | $ | 752,502 |
Investments, short-term | | | 124,039 | | | 22,838 |
Trade receivables, net | |
| 127,739 | |
| 96,787 |
Inventory, net | |
| 5,871 | |
| 5,357 |
Prepaid expenses | |
| 18,101 | |
| 16,014 |
Other current assets | |
| 11,981 | |
| 13,516 |
Total current assets | |
| 934,830 | |
| 907,014 |
NONCURRENT ASSETS: | |
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Investments, long-term | | | 280,467 | | | 107,127 |
Intangible assets, net | |
| 71,535 | |
| 89,418 |
Deferred tax asset | | | 161,365 | | | 149,699 |
Other noncurrent assets | |
| 30,048 | |
| 18,373 |
Total noncurrent assets | |
| 543,415 | |
| 364,617 |
TOTAL ASSETS | | $ | 1,478,245 | | $ | 1,271,631 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
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CURRENT LIABILITIES: | |
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Trade payables | | $ | 26,919 | | $ | 17,693 |
Accrued compensation | |
| 14,886 | |
| 18,443 |
Accrued expenses | |
| 208,062 | |
| 191,039 |
Current portion of long-term debt | | | 20,000 | | | 20,000 |
Other current liabilities | |
| 1,675 | |
| 4,957 |
Total current liabilities | |
| 271,542 | |
| 252,132 |
NONCURRENT LIABILITIES: | |
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Long-term debt, net | |
| 129,104 | |
| 143,663 |
Other noncurrent liabilities | |
| 5,367 | |
| 5,618 |
Total noncurrent liabilities | |
| 134,471 | |
| 149,281 |
TOTAL LIABILITIES | |
| 406,013 | |
| 401,413 |
COMMITMENTS AND CONTINGENCIES (Note 13) | |
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STOCKHOLDERS’ EQUITY: | |
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Common stock—$0.00001 par value; 500,000,000 shares authorized at September 30, 2026 and December 31, 2025, respectively; 58,720,081 and 57,726,170 shares issued and outstanding at September 30, 2026, and December 31, 2025, respectively | |
| 1 | |
| 1 |
Additional paid in capital | |
| 757,153 | |
| 708,968 |
Accumulated other comprehensive (loss) income | | | (1,940) | | | 346 |
Retained earnings | |
| 317,018 | |
| 160,903 |
TOTAL STOCKHOLDERS’ EQUITY | |
| 1,072,232 | |
| 870,218 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 1,478,245 | | $ | 1,271,631 |
Harmony Biosciences Investor Contact:
Brennan Doyle
484-566-3685
bdoyle@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
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| Copyright © 2026 Harmony Biosciences. All rights reserved. Q3 2026 Financial Results and Business Update November 4, 2026 |
| Forward-Looking Statements This presentation 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, the potential profile of our product candidates, our planned and ongoing clinical trials and expected timing of data readouts, anticipated regulatory milestones and product launches, our future results of operations and financial position, our intellectual property, pending litigation and regulatory exclusivity, our planned leadership transition, market opportunity, business strategy, business development, products, prospective products, product approvals, and the plans and objectives of management for future operations. 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 GR 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. 2 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. |
| Multi-layered IP strategy across active legal proceedings reinforces confidence in WAKIX exclusivity to March 2030 PROTECT THE PITOLISANT FRANCHISE 5 Phase 3 registrational trials in 5 distinct rare CNS indications Led by BP-205, a potentially best-in-class OX2R agonist ADVANCE B P - 205 AND THE NEXT WAVE OF INNOVATION Continued WAKIX growth in an evolving market On track to achieve more than $1B full year net revenue GROW THE WAKIX ® FRANCHISE GROWING ADVANCING TRANSACTING PROTECTING Strong balance sheet and clear conviction to execute on strategic business development opportunities EXECUTING AGAINST FOUR VALUE CREATION PRIORITIES EMPHASIS ON BUSINESS DEVELOPMENT 3 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. |
| TWO KEY HIGHLIGHTS FOR THIS QUARTER STRONG COMMERCIAL QUARTER $269M • Third quarter net product revenue for WAKIX • 40% CAGR over past 5 years • 400 Net Patient Adds, 9,350 Average Patients POTENTIAL BEST-IN-CLASS OX2R BP-205 • Favorable multiple-ascending dose (MAD) data: 14 days of once-daily dosing reinforce the safety, tolerability and PK profile observed in the SAD study • Most potent of OX2R agonists currently in the clinic • Phase 1b sleep-deprived healthy volunteer data expected Q1 2027; Phase 2 studies in multiple CNS indications expected to initiate by mid-2027 Value Inflection: On Track For More Than $1B WAKIX Net Revenue & Multiple BP-205 Data Catalysts Ahead GROWING ADVANCING 4 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. |
| Multi-layered IP strategy across active legal proceedings reinforces confidence in WAKIX exclusivity to March 2030 PROTECT THE PITOLISANT FRANCHISE 5 Phase 3 registrational trials in 5 distinct rare CNS indications Led by BP-205, a potentially best-in-class OX2R agonist ADVANCE B P - 205 AND THE NEXT WAVE OF INNOVATION Continued WAKIX growth in an evolving market On track to achieve more than $1B full year net revenue GROW THE WAKIX ® FRANCHISE GROWING ADVANCING TRANSACTING PROTECTING Strong balance sheet and clear conviction to execute on strategic business development opportunities EXECUTING AGAINST FOUR VALUE CREATION PRIORITIES EMPHASIS ON BUSINESS DEVELOPMENT 5 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. |
| WAKIX® Differentiation and Strong Execution Drive Performance 6 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. KEY TAKEAWAY Average Patients on WAKIX Continued Demand-Driven Growth in Q3 '26 • $269M net revenue in Q3 '26 • 400 net patient adds, 9,350 average patients • 400+ net patient adds in 5 of the last 6 quarters BROAD PAYER ACCESS EXPANDED TEAM DIFFERENTIATED PRODUCT |
| Growth Opportunity Across the Narcolepsy Market • ~170K total narcolepsy patients • <50% diagnosed patients • ~20% brand penetration in polypharmacy market People Living With Narcolepsy in the U.S.1 80,000 90,000 ~170,000 Diagnosed Narcolepsy Patients Undiagnosed Narcolepsy Population KEY TAKEAWAY LARGE MARKET OPPORTUNITY 7 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. Significant Growth Opportunity Remains for WAKIX and Next-Gen Pitolisant Formulations 1. https://narcolepsynetwork.org/ accessed Feb 2024 |
| Reiterating 2026 WAKIX Net Revenue Guidance 8 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. $1.00B-$1.04B 2026 NET REVENUE GUIDANCE WAKIX Net Revenue Growth 2020–2025 $160 $305 $438 $582 $715 $869 $1B+ $0 $200 $400 $600 $800 $1,000 2020 2021 2022 2023 2024 2025 2026 Guidance Net Revenue ($M) On Track to Achieve $1B+ in Net Sales |
| Advancing BP-205 and a Catalyst-Rich Pipeline for Long-Term Growth 9 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING Research collaboration with CiRC Biosciences. Innovative Clinical-Stage Pipeline With Multiple Catalysts 2026–2028 BP-205 (Orexin-2 Receptor Agonist) Multiple CNS Indications Pitolisant Pitolisant Gastro-Resistant (GR) in Narcolepsy Prader-Willi Syndrome (PWS) Pitolisant High-Dose (HD) in Narcolepsy Pitolisant High-Dose (HD) in Idiopathic Hypersomnia Pitolisant Amorphous Form CBS105 Treatment-Resistant Narcolepsy EPX-100 (Clemizole Hydrochloride) Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS) CBS104 Refractory Epilepsy |
| BP-205: Multiple-Ascending Dose (MAD) Phase 1 Study in Healthy Volunteers 10 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, HEALTHY PARTICIPANTS 14 days of repeated once-daily dosing DOSES EVALUATED BP-205 0.1 mg, 0.6 mg, 1 mg and 3 mg once daily in 94 healthy volunteers BUILDS ON THE SINGLE-ASCENDING DOSE (SAD) STUDY SAD study evaluated single doses of 0.2 mg to 6.0 mg in 72 healthy volunteers PRELIMINARY RESULTS Complete MAD study results to be presented at an upcoming medical meeting BP-205 MAD Study Design |
| BP-205: Multiple-Ascending Dose (MAD) Phase 1 Study Data Highlights 11 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. PRELIMINARY DATA AFTER 14 DAYS OF DAILY DOSING (0.1 TO 3 MG): • Rapid absorption with a mean Tmax of ~60 minutes (range 30 to 90 minutes) o Supports potential for rapid onset of efficacy • Mean effective T1/2 of ~29 hours after 14 days of dosing o No clinically meaningful change vs. SAD; supports once-daily dosing • Dose-related exposure and target engagement AEs o Potential to deliver efficacy at low clinical doses • Generally well tolerated across all doses evaluated o No serious or severe TEAEs o No liver or visual AEs; no clinically significant cardiovascular events or EKG abnormalities o Most common AE was headache (~25% of participants) • On-target AEs were mild and did not lead to discontinuation o Insomnia in <20% of participants, observed at all doses o Urinary frequency/urgency in <20% of participants, at 1 and 3 mg only Supports an Emerging Best-in-Class Profile |
| BP-205 Development Plan 12 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. Q3 2026: ENCOURAGING SINGLE-ASCENDING DOSE (SAD) DATA Q4 2026: FAVORABLE PRELIMINARY PHASE 1 MAD RESULTS Q1 2027: PHASE 1B DATA IN SLEEP-DEPRIVED HEALTHY VOLUNTEERS MID-2027: TO INITIATE PHASE 2 STUDIES IN MULTIPLE CNS INDICATIONS Multiple Phase 2 Studies Expected by Mid-2027 |
| Combination of BP-205 and Pitolisant: Synergistic Wake-Promoting Effects • In-vivo data in the narcoleptic mice model showed synergistic wake-promoting effects with BP-205 (OX2R agonist) and pitolisant (histaminergic) MoA • Pitolisant on top of BP-205 drove maximal histamine release (+205%) vs BP-205 (+94%) or pitolisant (+173%) alone • Combining an OX2R agonist with histaminergic MoA (e.g., pitolisant) could be a new therapeutic approach for patients with narcolepsy and other central disorders of hypersomnolence Poster Presented by Bioprojet at SLEEP EU 2026 KEY TAKEAWAY PRECLINICAL DATA 13 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. Potential New Therapeutic Approach in Central Disorders of Hypersomnolence Source: Missaire M, et al. Sleep Europe 2026, Maastricht, October 20-23, 2026. Preclinical data. |
| Next-Generation Pitolisant Programs 14 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. PITOLISANT GR – NDA UNDER FDA REVIEW; ON TRACK TO LAUNCH IN 1H 2027 PDUFA date April 1, 2027 PITOLISANT HD – ONGOING PHASE 3 REGISTRATIONAL STUDIES IN NARCOLEPSY AND IH TLD expected in 2027; Anticipated PDUFA in 2028 UTILITY PATENTS FILED FOR BOTH GR AND HD Potential to extend the pitolisant franchise into the 2040s PITOLISANT PHASE 3 STUDY IN PWS (TEMPO): ON TRACK FOR PEDIATRIC EXCLUSIVITY TLD expected in mid-2027; Anticipated PDUFA in 2028 AMORPHOUS FORM OF PITOLISANT • Licensed Novitium patent provides protection to 2042 • Formulation optimization and new modes of delivery ongoing Positioned to Extend Pitolisant Franchise Into 2040s |
| EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 15 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION ONGOING PHASE 3 TRIALS IN LENNOX-GASTAUT SYNDROME & DRAVET SYNDROME TLD expected mid-2027; Anticipated PDUFA dates in 2028 18-MONTH ARGUS OPEN-LABEL EXTENSION DATA Updated data to be presented at AES Annual Meeting in December 2026 SAFETY: POTENTIAL TO OFFER A UNIQUE RISK/BENEFIT PROPOSITION No additional laboratory or special safety monitoring BID DOSING REGIMEN Convenient for patients and caregivers Phase 3 Topline Data Expected Mid-2027 |
| Emphasis on Business Development 16 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. TWO CATEGORIES OF OPPORTUNITY • Assets that can add near-term revenue in 2028 to 2032 to support our self-funded model • Innovative pipeline assets that drive long-term value creation (e.g., BP-205) LEVERAGE CORE COMPETENCIES THERAPEUTIC AREAS OF INTEREST • Sleep Disorders • Epilepsy • Rare/Orphan CNS • Broader CNS indications AGNOSTIC TO DEAL TYPE • M&A, licensing, etc. STRONG BALANCE SHEET WITH ~ $1.05B IN CASH Capacity & Conviction to Transact |
| Protect the Pitolisant Franchise 17 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. WAKIX EXCLUSIVITY TO MARCH 2030, WITH PEDIATRIC EXCLUSIVITY STRONG IP PROTECTS WAKIX TO MARCH 2030, INCLUSIVE OF PEDIATRIC EXCLUSIVITY • Asserting pitolisant IP in active legal proceedings, each covering a different aspect SETTLEMENTS WITH 6 OF 7 ANDA FILERS ANDA CASE: DEFENDING POLYMORPH ‘197 AND METHOD OF USE ‘947 PATENTS • ANDA litigation closing arguments held on October 22, 2026; ruling expected around the end of the 30-month stay (February 2027) AMORPHOUS ‘920 PATENT INFRINGEMENT • Harmony and Novitium filed patent infringement lawsuit in April against AET Pharma US and its marketing partner Sandoz; licensed Novitium patent provides protection to 2042 • Trial for '920 patent case not scheduled yet; likely to be scheduled for some time in 2029 • Preliminary injunction hearing scheduled for January 26, 2027; ruling expected by February 14, ahead of the 30-month stay |
| $0.87 $0.81 Q3 2025 Q3 2026 $2.32 $2.63 9M 2025 9M 2026 Financial Summary Q3 2026 18 • Continued sales growth in Q3 supported by strong underlying demand for WAKIX. • Reiterating full year WAKIX net revenue guidance of $1.0B - $1.04B for 2026. • Cash generation of $89M in Q3, sustaining our strong balance sheet. • We intend to deploy cash to drive our BP-205 development plans, as well as to transact on potential business development opportunities. $239.5 $268.9 Q3 2025 Q3 2026 $778.4 $882.5 $870.5 $962.5 $1,051.6 Q3 2025 Q4 2025 Q1 2026 Q2 2026 Q3 2026 Three Months Ended September 30, 2026 (In millions, USD) Net Product Revenue Diluted Earnings per Share Cash, Cash Equivalents & Investments +12% +$89M Three Months Ended September 30, 2026 $624.7 $745.6 9M 2025 9M 2026 Nine Months Ended September 30, 2026 +19% -7% Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. Nine Months Ended September 30, 2026 +13% |
| Financial Summary Q3 2026 19 • Cost of Product Sold increase due to new royalties related to Novitium License Agreement signed in Q1 2026. • R&D Expense: • Q3 increase primarily due to $25.0M charge for MSN license milestone. • Partially offset by $15.0M charge for ZYN002 milestone in prior year quarter. • Sales & Marketing Expenses increase primarily due to expansion of our field-based team. • G&A Expense decrease primarily due to lower stock-based compensation. Totals may not foot due to rounding Three Months Ended September 30, % Change Nine Months Ended September 30, % Change 2026 2025 2026 2025 Net Product Revenue $268.9 $239.5 12% $745.6 $624.7 19% Cost of Product Sold 80.7 59.7 35% 188.4 129.8 45% Total Operating Expenses $134.0 $114.3 17% $376.4 $325.0 16% R&D Expense 71.7 55.0 30% 187.7 139.7 34% Sales & Marketing Expense 34.7 29.5 18% 100.5 90.3 11% G&AExpense 27.7 29.8 -7% 88.2 95.0 -7% Net Income $48.2 $50.9 -5% $156.1 $136.2 15% Cash, cash equivalents & investments $1,051.6 $778.4 35% (In millions, USD) Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. |
| Multi-layered IP strategy across active legal proceedings reinforces confidence in WAKIX exclusivity to March 2030 PROTECT THE PITOLISANT FRANCHISE 5 Phase 3 registrational trials in 5 distinct rare CNS indications Led by BP-205, a potentially best-in-class OX2R agonist ADVANCE B P - 205 AND THE NEXT WAVE OF INNOVATION Continued WAKIX growth in an evolving market On track to achieve more than $1B full year net revenue GROW THE WAKIX ® FRANCHISE GROWING ADVANCING TRANSACTING PROTECTING Strong balance sheet and clear conviction to execute on strategic business development opportunities EXECUTING AGAINST FOUR VALUE CREATION PRIORITIES EMPHASIS ON BUSINESS DEVELOPMENT 20 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. |
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| company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com |
