Harmony Biosciences Holdings, Inc.

Previous wording

This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, products, prospective products, product approvals, research and development costs, anticipated timing and likelihood of success of clinical trials, expected timing of the release of clinical trial data, the plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these items or similar expressions.

Current wording

This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, liquidity and capital resources, including the sufficiency of our cash, cash equivalents and investments to fund our operations, business strategy, including business development activities, our commercial products, including expected sales of, and market opportunity for, WAKIX; our product candidates and their potential benefits and differentiation; the development and expansion of our pipeline, product approvals and the timing and outcome of regulatory submissions and reviews, including target PDUFA dates; research and development and other costs and expenses, anticipated timing and likelihood of success of clinical trials, the expected timing of the release of clinical trial data, the plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these items or similar expressions.

Previous wording

At Harmony, we are cultivating a differentiated neuroscience company, rooted in innovation and driven by a commitment to addressing the unmet needs of patients living with neurological diseases. To date, we have focused on rare neurological diseases with a growing portfolio now spanning sleep/wake and rare epilepsy, and we are harnessing scientific insights and pioneering approaches to advance meaningful treatments that help patients thrive. Our operations are conducted by our wholly owned subsidiaries, Harmony Biosciences, LLC and Harmony Biosciences Management, Inc.

Current wording

At Harmony, we are cultivating a differentiated neuroscience company, rooted in innovation and driven by a commitment to addressing the unmet needs of patients living with neurological diseases. To date, we have focused on rare neurological diseases with a growing portfolio now spanning sleep/wake and rare epilepsy, and we are harnessing scientific insights and pioneering approaches as we move forward to advance meaningful treatments that help patients thrive in both rare and broad diseases. Our operations are conducted by our wholly owned subsidiaries, Harmony Biosciences, LLC and Harmony Biosciences Management, Inc.

Previous wording

Our pitolisant franchise is anchored by WAKIX, an oral, once-daily therapy licensed from Bioprojet Société Civile de Recherche (“Bioprojet”) for the treatment of narcolepsy. WAKIX is approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of excessive daytime sleepiness (“EDS”) and cataplexy in patients six years and older with narcolepsy. WAKIX is a first-in-class molecule with a novel mechanism of action (“MOA”) and is the only selective H 3 receptor antagonist/inverse agonist approved by the FDA. Additionally, it is the first-and-only FDA-approved treatment that is not scheduled as a controlled substance by the United States Drug Enforcement Administration (the “DEA”).

Current wording

Our pitolisant franchise is anchored by WAKIX, an oral, once-daily therapy licensed from Bioprojet Société Civile de Recherche (“Bioprojet”) for the treatment of narcolepsy. WAKIX is approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of excessive daytime sleepiness (“EDS”) and cataplexy in patients six years and older with narcolepsy. WAKIX is a first-in-class molecule with a novel mechanism of action (“MOA”) and is the only selective H 3 receptor antagonist/inverse agonist approved by the FDA. Additionally, it is the first-and-only FDA-approved treatment for patients with narcolepsy that is not scheduled as a controlled substance by the United States Drug Enforcement Administration (the “DEA”).

Previous wording

We are focusing development efforts on other rare neurological diseases in which EDS is a prominent symptom, including Prader-Willi Syndrome (“PWS”), and remain committed to obtaining pediatric exclusivity for WAKIX. In 2024, we initiated the PWS Phase 3 registrational trial, the TEMPO study, in support of these efforts. We anticipate topline data from the TEMPO study in mid-2027.

Current wording

We are focusing development efforts on other rare neurological diseases in which EDS is a prominent symptom, including Prader-Willi Syndrome (“PWS”), and remain committed to obtaining pediatric exclusivity for

Previous wording

We are developing two new formulations of pitolisant through a license agreement with Bioprojet: Pitolisant GR and Pitolisant HD. Pitolisant GR is designed with an enteric coating meant to reduce the potential for gastrointestinal side effects in patients prone to gastrointestinal symptoms, and to enable patients to initiate treatment at a therapeutic dose without titration, which we believe is an important clinical differentiation. In June 2026, we submitted a New Drug Application (“NDA”) for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act (“PDUFA”) date of April 1, 2027. Pitolisant HD is an enhanced formulation of pitolisant with an optimized pharmacokinetic (“PK”) profile, enteric coating and higher dosing to drive greater efficacy. It is designed to provide differentiated labeling for fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia (“IH”). Pitolisant HD is currently in a Phase 3 registrational trial in narcolepsy, ONSTRIDE1, and a Phase 3 registrational trial in IH, ONSTRIDE2. We expect topline data in 2027 and anticipate a target PDUFA date in 2028. Utility patents for both Pitolisant GR and Pitolisant HD have been filed to extend the pitolisant franchise into the 2040s.

Current wording

We are developing two new formulations of pitolisant through a license agreement with Bioprojet: Pitolisant GR and Pitolisant HD. Pitolisant GR is designed with an enteric coating meant to reduce the potential for gastrointestinal side effects in patients prone to gastrointestinal symptoms, and to enable patients to initiate treatment at a therapeutic dose without titration, which we believe is an important clinical differentiation. In June 2026, we submitted a New Drug Application (“NDA”) for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act (“PDUFA”) date of April 1, 2027. Pitolisant HD is an enhanced formulation of pitolisant with an optimized pharmacokinetic (“PK”) profile, enteric coating, and higher dosing to drive greater efficacy, and enables patients to initiate treatment at a therapeutic dose without titration. It is designed to provide differentiated labeling for fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia (“IH”). Pitolisant HD is currently in a Phase 3 registrational trial in narcolepsy, ONSTRIDE1, and a Phase 3 registrational trial in IH, ONSTRIDE2. We expect topline data in 2027 and anticipate a target PDUFA date in 2028. Utility patents for both Pitolisant GR and Pitolisant HD have been filed to extend the pitolisant franchise into the 2040s.

Previous wording

BP-205 is built on a novel chemical scaffold with the potential for best-in-class therapy due to its high potency. We intend to develop BP-205 for the treatment of multiple central nervous system (“CNS”) indications outside of sleep/wake. We filed an investigational medicinal product dossier (“IMPD”) with the EMA and began first-in-human studies in the fourth quarter of 2025. The topline data from the single ascending dose (“SAD”) study are encouraging and supportive of a potential best-in-class profile for an orexin 2 receptor agonist. In July 2026, we submitted an Investigational New Drug application (“IND”) to the FDA, which is now open, and are preparing to initiate a Phase 1b study in sleep-deprived healthy volunteers.

Current wording

BP-205 is built on a novel chemical scaffold with the potential for best-in-class therapy due to its high potency. We intend to develop BP-205 for the treatment of multiple CNS indications. We filed an investigational medicinal product dossier (“IMPD”) with the EMA and began first-in-human studies in the fourth quarter of 2025. The topline data from the single ascending dose (“SAD”) study are encouraging and supportive of a potential best-in-class profile for an orexin 2 receptor agonist. In July 2026, we submitted an Investigational New Drug application (“IND”) to the FDA, which is now open. During the third quarter of 2026, we initiated a Phase 1b study in sleep-deprived healthy volunteers. The BP-205 Phase 1 preliminary clinical PK data from the multiple ascending dose (“MAD”) study continue to be supportive of a potential best-in-class profile.

Previous wording

In January 2026, we entered into a license agreement (the “Novitium License Agreement”) with Novitium Pharma LLC (“Novitium”), which includes an exclusive license to additional intellectual property that will expand our patent estate, as well as a co-exclusive license, under which we intend to develop a new formulation of pitolisant in broad CNS indications outside of sleep/wake.

Current wording

In January 2026, we entered into a license agreement (the “Novitium License Agreement”) with Novitium Pharma LLC (“Novitium”), which includes an exclusive license to additional intellectual property that will expand our patent estate, as well as a co-exclusive license, under which we intend to develop an amorphous formulation of pitolisant in broad CNS indications outside of sleep/wake.

Previous wording

In February 2026, we entered into a license agreement (the “MSN License Agreement”) with MSN Laboratories Private Limited (“MSN”), which includes an exclusive, royalty-bearing license, with the right to grant sublicenses, to additional intellectual property, including pending licensed patents, under which we intend to develop a new formulation of pitolisant in broad CNS indications outside of sleep/wake.

Current wording

In February 2026, we entered into a license agreement (the “MSN License Agreement”) with MSN Laboratories Private Limited (“MSN”), which includes an exclusive, royalty-bearing license, with the right to grant sublicenses, to additional intellectual property, including licensed patents, under which we intend to develop an amorphous formulation of pitolisant in broad CNS indications outside of sleep/wake. In September 2026, the pending licensed patents were approved by the United States Patent and Trademark Office

Previous wording

In July 2026, we submitted an IND for BP-205 to the FDA, which is now open, and are preparing to initiate a Phase 1b study in sleep-deprived healthy volunteers in the third quarter of 2026, with topline data expected in early 2027. In August 2026, we announced Phase 1 clinical PK data from the SAD study for BP-205, which demonstrated favorable PK, safety, and tolerability profiles. Topline data from the Phase 1 multiple ascending dose study is expected in the fourth quarter of 2026. In addition, we plan to initiate Phase 2 trials for BP-205 in mid-2027 to evaluate multiple CNS indications.

Current wording

In July 2026, we submitted an IND for BP-205 to the FDA, which is now open, and initiated a Phase 1b study in sleep-deprived healthy volunteers in the third quarter of 2026, with topline data expected in the first quarter of 2027. In August 2026, we announced Phase 1 clinical PK data from the SAD study for BP-205, which demonstrated favorable PK, safety, and tolerability profiles. In November 2026, we announced topline data from the Phase 1 MAD study, which reinforced the favorable safety, tolerability and PK profile observed in the SAD portion of the study, with no liver or visual adverse events reported and no clinically significant cardiovascular events or electrocardiogram abnormalities recorded. In addition, we plan to initiate Phase 2 trials for BP-205 in mid-2027 to evaluate multiple CNS indications.

Previous wording

As of June 30, 2026, we have continued to see growth in the number of unique healthcare professionals (“HCP”) prescribing WAKIX since it became available in November 2019. There are approximately 9,000 HCPs who treat patients living with narcolepsy, with approximately 4,000 enrolled in oxybate risk-evaluation and mitigation strategies (“REMS”) programs. The average number of patients on WAKIX for the three months ended June 30, 2026, was approximately 8,950. Additionally, as of June 30, 2026, we have secured formulary access for more than 80% of all insured lives (Commercial, Medicare and Medicaid) in the United States.

Current wording

As of September 30, 2026, we have continued to see growth in the number of unique healthcare professionals (“HCP”) prescribing WAKIX since it became available in November 2019. There are approximately 9,000 HCPs who treat patients living with narcolepsy, with approximately 4,000 enrolled in oxybate risk-evaluation and mitigation strategies (“REMS”) programs. The average number of patients on WAKIX for the three months ended September 30, 2026, was approximately 9,350. Additionally, as of September 30, 2026, we have maintained formulary access for more than 80% of all insured lives (Commercial, Medicare and Medicaid) in the United States.

Previous wording

Theshelf life of WAKIX is four years from the date of manufacture, with the earliest expiration of current inventory expected to be May 2027. We regularly review our inventory levels and expect write-offs from time to time. We will continue to assess inventory levels in future periods as demand for WAKIX and the rate of inventory turnover evolves. We currently have adequate supply of WAKIX to cover demand into the fourth quarter of 2028, with additional API on-hand inventory to support at least 24 months beyond this time frame.

Current wording

Theshelf life of WAKIX is four years from the date of manufacture, with the earliest expiration of current inventory expected to be August 2027. We regularly review our inventory levels and expect write-offs from time to time. We will continue to assess inventory levels in future periods as demand for WAKIX and the rate of inventory turnover evolves. We currently have adequate supply of WAKIX tablets to cover demand into the fourth quarter of 2028, with additional API on-hand inventory to support at least 18 months beyond this time frame.

Previous wording

Research and development expenses primarily include development programs for potential new indications for pitolisant in patients with PWS, and the development of our product candidates EPX-100, Pitolisant GR, Pitolisant HD, and BP-205. We also incur research and development expenses related to our team of Medical Science Liaisons (“MSLs”) who interact with key opinion leaders, with a focus on the science, the role of histamine in sleep-wake state stability and the novel mechanism of action of pitolisant. In addition, our MSLs support our market access team with the presentation of clinical data to payors upon request and our clinical development team to identify potential clinical trial sites. Research and development costs are expensed as incurred. We have significantly increased our research and development efforts as we advance our clinical programs and add product candidates to expand our pipeline. Research and development expenses also include:

Current wording

Research and development expenses primarily include development programs for potential new indications for pitolisant in patients with PWS, and the development of our product candidates EPX-100, Pitolisant GR, Pitolisant HD, BP-205 and an amorphous form of pitolisant. We also incur research and development expenses related to our team of Medical Science Liaisons (“MSLs”) who interact with key opinion leaders, with a focus on the science, the role of histamine in sleep-wake state stability and the novel mechanism of action of pitolisant. In addition, our MSLs support our market access team with the presentation of clinical data to payors upon request and our clinical development team to identify potential clinical trial sites. Research and development costs are expensed as incurred. We have significantly increased our research and development efforts as we advance our clinical programs and add product candidates to expand our pipeline. Research and development expenses also include:

Previous wording

Product candidates in later stages of clinical development generally have higher development costs in the current period than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, milestone payments, and the cost of submitting an NDA to the FDA (and/or other regulatory authorities). We expect our research and development expenses to be significant as we advance our current clinical development programs and prepare to seek regulatory approval for Pitolisant GR, complete the Phase 3 clinical trials for additional indications for pitolisant, EPX-100 and Pitolisant HD, and advance the development of BP-205 and CBS105 toward new indications.

Current wording

Product candidates in later stages of clinical development generally have higher development costs in the current period than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, milestone payments, and the cost of submitting an NDA to the FDA (and/or other regulatory authorities). We expect our research and development expenses to be significant as we advance our current clinical development programs and seek regulatory approval for Pitolisant GR, complete the Phase 3 clinical trials for additional indications for pitolisant, EPX-100 and Pitolisant HD, and advance the development of BP-205, a new formulation of pitolisant and CBS-105 toward new indications.

Previous wording

We anticipate that our general and administrative expenses will increase in the future to support our continued commercialization efforts and ongoing and future potential research and development activities. These increases will likely be driven by costs associated with the hiring of additional personnel and fees paid to outside consultants, lawyers and accountants, among other expenses. Additionally, we anticipate increased costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the SEC, insurance and investor relations costs. If any of our current or future indication expansion programs or new product candidates obtain U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.

Current wording

We anticipate that our general and administrative expenses will increase in the future to support our continued commercialization efforts and ongoing and future potential research and development activities. These increases will likely be driven by costs associated with the hiring of additional personnel and fees paid to outside consultants, lawyers and accountants, among other expenses. Additionally, we face costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the SEC, insurance and investor relations costs. If any of our current or future indication expansion programs or new product candidates obtain U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.

Previous wording

We are party to a right-of-use agreement with Paragon whereby we have access to and the right to use certain office space leased by Paragon in Chicago, Illinois. We paid rental fees to Paragon of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively.

Current wording

We are party to a right-of-use agreement with Paragon whereby we have access to and the right to use certain office space leased by Paragon in Chicago, Illinois. We paid fees of $0.1 million and $0.2 million to Paragon related to rent and consulting fees for the three and nine months ended September 30, 2026, respectively.

Previous wording

Net product revenue increased by $60.8 million, or 30.3%, for the three months ended June 30, 2026, and increased by $91.4 million, or 23.7%, for the six months ended June 30, 2026, compared to the same periods in 2025. The increase for the three months ended June 30, 2026, was primarily due to a 26.5% increase in the number of units shipped and the impact of a 7% price increase partially offset by higher rebates of approximately 4.0%. The increase for the six months ended June 30, 2026, was primarily due to a 19.4% increase in the number of units shipped and the impact of a 7% price increase partially offset by higher rebates of approximately 3.8%. The price increase occurred in January 2026.

Current wording

Net product revenue increased by $29.5 million, or 12.3%, for the three months ended September 30, 2026, and increased by $120.9 million, or 19.4%, for the nine months ended September 30, 2026, compared to the same periods in 2025. The increase for the three months ended September 30, 2026, was primarily due to a 7.5% increase in the number of units shipped and the impact of a 7% price increase partially offset by higher rebates of approximately 2.0%. The increase for the nine months ended September 30, 2026, was primarily due to a 14.9% increase in the number of units shipped and the impact of a 7% price increase partially offset by higher rebates of approximately 3.2%. The price increase occurred in January 2026.

Previous wording

Cost of product sold increased by $25.0 million, or 65.6%, for the three months ended June 30, 2026, and increased by $37.6 million, or 53.5%, for the six months ended June 30, 2026, compared to the same periods in 2025. Cost of product sold as a percentage of net product revenue was 24.2% and 22.6% for the three and six months ended June 30, 2026, respectively, compared to 19.0% and 18.2% for the three and six months ended June 30, 2025, respectively. The increase in cost of product sold was primarily due to higher royalties as a result of the increase in net product revenue of WAKIX. The increase in the cost of product sold as a percentage of net revenue was driven by new royalties related to the Novitium License Agreement.

Current wording

Cost of product sold increased by $21.0 million, or 35.3%, for the three months ended September 30, 2026, and increased by $58.6 million, or 45.1%, for the nine months ended September 30, 2026, compared to the same periods in 2025. Cost of product sold as a percentage of net product revenue was 30.0% and 25.3% for the three and nine months ended September 30, 2026, respectively, compared to 24.9% and 20.8% for the three and nine months ended September 30, 2025, respectively. The increase in cost of product sold was primarily due to higher royalties as a result of the increase in net product revenue of WAKIX and new royalties related to the Novitium License Agreement. The increase in the cost of product sold as a percentage of net revenue was driven by new royalties related to the Novitium License Agreement.

Previous wording

Research and development expenses decreased by $3.6 million, or 7.1%, for the three months ended June 30, 2026, and increased by $31.3 million, or 36.9%, for the six months ended June 30, 2026, compared to the same periods in 2025. The decrease for the three months ended June 30, 2026, was primarily driven by a$15.0 million IPR&D charge related to the CiRC Agreement that occurred during the three months ended June 30, 2025, a $4.4 million decrease related to the phase out of the ZYN002 program in FXS, and a $1.7 million decrease in clinical development associated with pitolisant offset by a combined $16.4 million increase in research and development expenses for BP-205, EPX-100, and Pitolisant GR and HD as we progressed clinical trials and manufacturing, a $0.3 million increase in personnel costs associated with higher headcount, and a $0.4 million increase in stock compensation.

Current wording

Research and development expenses increased by $16.7 million, or 30.4%, for the three months ended September 30, 2026, and increased by $48.0 million, or 34.4%, for the nine months ended September 30, 2026, compared to the same periods in 2025. The increase for the three months ended September 30, 2026, was primarily driven by a$25.0 million IPR&D charge related to a patent milestone associated with the MSN License Agreement that was achieved during the three months ended September 30, 2026, a combined $14.4 million increase in research and development expenses for BP-205, EPX-100, and Pitolisant GR and HD as we progressed clinical trials and manufacturing, and a $0.1 million increase in stock compensation offset by a $15.0 million clinical milestone related to ZYN002 achieved during the three months ended September 30, 2025, a $5.8 million decrease related to the phase out of the ZYN002 program in FXS, and a $2.1 million decrease in clinical development associated with pitolisant.

Previous wording

The increase for the six months ended June 30, 2026, was primarily driven bya combined $24.7 million increase in research and development expenses for BP-205, EPX-100, and Pitolisant GR and HD as we progressed clinical trials and manufacturing, a $17.0 million increase in IPR&D charges related to the Novitium License Agreement ($15.0 million) and MSN License Agreement ($17.0 million) entered into during the six months ended June 30, 2026, offset by the CiRC Agreement ($15.0 million) entered into during the six months ended June 30, 2025, a $1.1 million increase in personnel costs associated with higher headcount, a $0.5 million increase in stock compensation associated with new equity awards, and a $1.0 million increase in other research and development expenses offset by a $11.3 million decrease related to the phase out of the ZYN002 program in FXS and a $1.7 million decrease in clinical development associated with pitolisant.

Current wording

The increase for the nine months ended September 30, 2026, was primarily driven bya combined $39.1 million increase in research and development expenses for BP-205, EPX-100, and Pitolisant GR and HD as we progressed clinical trials and manufacturing, a $27.0 million increase in IPR&D charges composed of upfront license fees related to the Novitium License Agreement ($15.0 million) and the MSN License Agreement ($17.0 million) and a patent milestone associated with the MSN License Agreement ($25.0 million), all of which occurred during the nine months ended September 30, 2026, offset by a ZYN002 clinical milestone ($15.0 million) and entrance into the CiRC Agreement ($15.0 million), both of which occurred during the nine months ended September 30, 2025, a $0.9 million increase in personnel costs associated with higher headcount, a $0.6 million increase in stock compensation associated with new equity awards, and a $1.4 million increase in other research and development expenses offset by a $17.1 million decrease related to the phase out of the ZYN002 program in FXS and a $3.8 million decrease in clinical development associated with pitolisant.

Previous wording

Sales and marketing expenses increased by $4.0 million, or 13.5%, for the three months ended June 30, 2026, and increased by $5.0 million, or 8.3%, for the six months ended June 30, 2026, compared to the same periods in 2025. The increase for the three months ended June 30, 2026, was primarily due to a $2.0 million increase in patient engagement and marketing activities, a $1.6 million increase in personnel costs, a $0.2 million increase in travel expenses and a $0.2 million increase in stock compensation expense. The increase for the six months ended June 30, 2026, was primarily due to a $4.5 increase in patient engagement and marketing activities and a $2.1 million increase in personnel costs offset by a $0.8 million decrease in stock compensation expense and a $0.8 million decrease in travel expenses. The increase in patient engagement and marketing activities was driven by our continued growth of WAKIX and the increase in personnel costs was driven primarily by higher headcount as a result of our sales force expansion.

Current wording

Sales and marketing expenses increased by $5.2 million, or 17.5%, for the three months ended September 30, 2026, and increased by $10.2 million, or 11.3%, for the nine months ended September 30, 2026, compared to the same periods in 2025. The increase for the three months ended September 30, 2026, was primarily due to a $2.2 million increase in patient engagement and marketing activities, a $2.2 million increase in personnel costs, a $0.5 million increase in travel expenses and a $0.2 million increase in stock compensation expense. The increase for the nine months ended September 30, 2026, was primarily due to a $6.4 million

Previous wording

General and administrative expenses decreased by $5.9 million, or 17.3%, for the three months ended June 30, 2026, and decreased by $4.6 million, or 7.1%, for the six months ended June 30, 2026, compared to the same periods in 2025. The decrease for the three months ended June 30, 2026, was primarily due to a $5.1 million decrease in legal and professional fees and a $2.4 million decrease in stock compensation offset by a $1.6 million increase in personnel costs. The decrease for the six months ended June 30, 2026, was primarily due to a $2.8 million decrease in legal and professional fees and a $3.7 million decrease in stock compensation offset by a $1.9 million increase in personnel costs. The decrease in legal and professional fees for both comparable periods was primarily driven by expenses incurred due to ANDA settlements and lower ANDA litigation during the three and six months ended June 30, 2025. The increase in personnel costs for both comparable periods was primarily driven by higher headcount during the three and six months ended June 30, 2026.

Current wording

General and administrative expenses decreased by $2.2 million, or 7.2%, for the three months ended September 30, 2026, and decreased by $6.8 million, or 7.1%, for the nine months ended September 30, 2026, compared to the same periods in 2025. The decrease for the three months ended September 30, 2026, was primarily due to a $1.3 million decrease in legal and professional fees and a $3.0 million decrease in stock compensation partially offset by a $1.3 million increase in personnel costs. The decrease for the nine months ended September 30, 2026, was primarily due to a $4.6 million decrease in legal and professional fees and a $6.7 million decrease in stock compensation partially offset by a $3.2 million increase in personnel costs. The decrease in legal and professional fees during the three months ended September 30, 2026, was primarily due to lower Abbreviated New Drug Application (“ANDA”) litigation expenses compared to the prior year period. The decrease in legal and professional fees during the nine months ended September 30, 2026, was primarily due to fewer ANDA settlements and lower litigation expenses compared to the prior year period. The increase in personnel costs for both comparable periods was primarily driven by higher headcount and severance during the three and nine months ended September 30, 2026.

Previous wording

Interest expense decreased by $0.6 million, or 15.8%, for the three months ended June 30, 2026, and decreased by $1.2, or 15.7%, for the six months ended June 30, 2026, compared to the same periods in 2025. The decrease for the three and six months ended June 30, 2026, was primarily due to lower average outstanding debt balances and lower interest rates compared to the same periods in the prior year.

Current wording

Interest expense decreased by $0.6 million, or 15.5%, for the three months ended September 30, 2026, and decreased by $1.7 million, or 15.7%, for the nine months ended September 30, 2026, compared to the same periods in 2025. The decrease for the three and nine months ended September 30, 2026, was primarily due to lower average outstanding debt balances and lower interest rates compared to the same periods in the prior year.

Previous wording

Interest income increased by $1.8 million, or 33.5%, for the three months ended June 30, 2026, and increased by $2.5 million, or 24.1%, for the six months ended June 30, 2026, compared to the same periods in 2025. The increase for the three and six months ended June 30, 2026, was primarily a result of having higher invested balances compared to the prior year.

Current wording

Interest income increased by $2.7 million, or 47.1%, for the three months ended September 30, 2026, and increased by $5.2 million, or 32.3%, for the nine months ended September 30, 2026, compared to the same periods in 2025. The increase for the three and nine months ended September 30, 2026, was primarily a result of having higher invested balances compared to the prior year.

Previous wording

Income tax expense was $17.8 million, representing a 19.1% effective tax rate, for the three months ended June 30, 2026, compared to $9.9 million, representing a 19.9% effective tax rate, for the three months ended June 30, 2025. Income tax expense was $25.0 million, representing an 18.8% effective tax rate, for the six months ended June 30, 2026, compared to $21.5 million, representing a 20.1% effective tax rate, for the six months ended June 30, 2025. The decrease in our effective tax rate for both comparable periods was primarily driven by an increase in the benefits from research and development and orphan drug credits. The effective tax rate of 19.1% for the three months ended June 30, 2026, included 1.6% in state income taxes offset by a 4.1% benefit from credits. The effective tax rate of 18.8% for the six months ended June 30, 2026, included 1.5% in state income taxes offset by a 4.1% benefit from credits.

Current wording

Income tax expense was $11.1 million, representing an 18.7% effective tax rate, for the three months ended September 30, 2026, compared to $16.6 million, representing a 24.6% effective tax rate, for the three months ended September 30, 2025. Income tax expense was $36.1 million, representing an 18.8% effective tax rate, for the nine months ended September 30, 2026, compared to $38.1 million, representing a 21.9% effective tax rate, for the nine months ended September 30, 2025. The decrease in our effective tax rate for both comparable periods was primarily driven by an increase in the benefits from research and development and orphan drug credits. The effective tax rate of 18.7% for the three months ended September 30, 2026, included 2.8% in state income taxes offset by a 6.7% benefit from credits. The effective tax rate of 18.8% for the nine months ended September 30, 2026, included 1.9% in state income taxes offset by a 4.9% benefit from credits.

Previous wording

As of June 30, 2026, we had cash, cash equivalents, and investments of $962.5 million, outstanding debt of $155.0 million and retained earnings of $268.8 million.

Current wording

As of September 30, 2026, we had cash, cash equivalents, and investments of $1,052.0 million, outstanding debt of $150.0 million and retained earnings of $317.0 million.

Previous wording

In October 2023, our Board of Directors approved a share repurchase program (the “October 2023 Repurchase Program”) providing for the repurchase of shares of common stock in an aggregate amount of up to $200,000, excluding commissions and transaction fees. The October 2023 Repurchase Program may be suspended, terminated, or modified at any time for any reason. During the three and six months ended June 30, 2026, no shares of common stock were repurchased by the Company under the October 2023 Repurchase Program. As of June 30, 2026, the remaining amount of common stock authorized for repurchases was $150.0 million.

Current wording

In October 2023, our Board of Directors approved a share repurchase program (the “October 2023 Repurchase Program”) providing for the repurchase of shares of common stock in an aggregate amount of up to $200.0 million, excluding commissions and transaction fees. The October 2023 Repurchase Program may be suspended, terminated, or modified at any time for any reason. During the three and nine months ended September 30, 2026, no shares of common stock were repurchased by the Company under the October 2023 Repurchase Program. As of September 30, 2026, the remaining amount of common stock authorized for repurchases was $150.0 million.

Previous wording

In July 2022, we entered into the 2022 LCA with Bioprojet whereby we obtained exclusive rights to manufacture, develop and commercialize one or more new products based on pitolisant in the United States and Latin America, with the potential to add additional indications and formulations upon the agreement of both parties. We paid an initial, non-refundable $30.0 million licensing fee in October 2022 and additional payments of up to $155.0 million are potentially due under the 2022 LCA upon the achievement of certain future development and sales-based milestones. In addition, certain payments will become due upon the achievement of development milestones for new indications and formulations as agreed upon by both parties. The 2022 LCA also includes a fixed trademark royalty and a tiered royalty based on net sales of any new products commercialized, which will be payable to Bioprojet on a quarterly basis.

Current wording

parties. We paid an initial, non-refundable $30.0 million licensing fee in October 2022 and additional payments of up to $155.0 million are potentially due under the 2022 LCA upon the achievement of certain future development and sales-based milestones. In addition, certain payments will become due upon the achievement of development milestones for new indications and formulations as agreed upon by both parties. The 2022 LCA also includes a fixed trademark royalty and a tiered royalty based on net sales of any new products commercialized, which will be payable to Bioprojet on a quarterly basis.

Previous wording

In January 2026, we entered into the Novitium License Agreement with Novitium, which includes an exclusive license to additional intellectual property that will expand our patent estate, as well as a co-exclusive license, under which we intend to develop a new formulation of pitolisant in broad CNS indications outside of sleep/wake. Pursuant to the Novitium License Agreement, we paid an upfront license fee of $15.0 million, which was recognized as an IPR&D charge recorded in research and development within the unaudited condensed consolidated statements of operations and comprehensive income for the six months ended June 30, 2026, and will also be obligated to pay up to $10.0 million upon the achievement of certain development milestones, as well as low single-digit royalties on net sales of pitolisant based products.

Current wording

In January 2026, we entered into the Novitium License Agreement with Novitium, which includes an exclusive license to additional intellectual property that will expand our patent estate, as well as a co-exclusive license, under which we intend to develop an amorphous formulation of pitolisant in broad CNS indications outside of sleep/wake. Pursuant to the Novitium License Agreement, we paid an upfront license fee of $15.0 million, which was recognized as an IPR&D charge recorded in research and development within the unaudited condensed consolidated statements of operations and comprehensive income for the nine months ended September 30, 2026, and will also be obligated to pay $10.0 million upon the achievement of certain development milestones, as well as low single-digit royalties on net sales of current and future pitolisant based products.

Previous wording

On February 25, 2026 (the “MSN Effective Date”), we entered into the MSN License Agreement with MSN, which includes an exclusive, royalty-bearing license, with the right to grant sublicenses, to additional intellectual property, including pending licensed patents, under which we intend to develop a new formulation of pitolisant in broad CNS indications outside of sleep/wake. Pursuant to the MSN License Agreement, we paid an upfront license fee of $17.0 million, which was recognized as an IPR&D charge recorded in research and development within the unaudited condensed consolidated statements of operations and comprehensive income for the six months ended June 30, 2026. In addition, we will be obligated to pay $25.0 million upon approval of the pending licensed patents by the United States Patent and Trademark Office (“USPTO”), which amount we must deposit into an escrow account within nine months from the MSN Effective Date, and which will be returned us if approval by the USPTO does not occur by November 25, 2027. In addition, we will be obligated to pay low single-digit royalties on net sales of future products that include a new formulation of pitolisant.

Current wording

In February 2026, we entered into the MSN License Agreement with MSN, which includes an exclusive, royalty-bearing license, with the right to grant sublicenses, to additional intellectual property, including licensed patents, under which we intend to develop an amorphous formulation of pitolisant in broad CNS indications outside of sleep/wake. Pursuant to the MSN License Agreement, we paid an upfront license fee of $17.0 million, which was recognized as an IPR&D charge recorded in research and development within the unaudited condensed consolidated statements of operations and comprehensive income for the nine months ended September 30, 2026. In September 2026, a milestone was achieved upon approval of MSN’s pending licensed patents by the USPTO which triggered a $25.0 million payment, which was recognized as an IPR&D charge recorded in research and development in the unaudited condensed consolidated statements of operations and comprehensive income for the three and nine months ended September 30, 2026. The milestone payment is expected to be paid in the fourth quarter of 2026. In addition, we will be obligated to pay low single-digit royalties on net sales of future products that include a new formulation of pitolisant, if covered by a patent provided under the MSN License Agreement.

Previous wording

The following table sets forth a summary of our cash flows for the six months ended June 30, 2026, and 2025:

Current wording

The following table sets forth a summary of our cash flows for the nine months ended September 30, 2026, and 2025:

Previous wording

Net cash provided by operating activities for the six months ended June 30, 2026, primarily consisted of net income of $107.9 million adjusted for non-cash items of $19.9 million related to stock-based compensation expense, $32.0 million related to acquired IPR&D, $11.9 million related to intangible amortization and depreciation, offset by $7.1 million related to deferred tax assets. Net working capital excluding cash increased by $45.4 million, primarily driven by increases in accounts receivable due to higher net product revenue in the current period and a decrease in accrued expenses primarily from lower accrued royalties and legal and professional feels offset by an increase in accounts payable due to the timing of payments.

Current wording

Net cash provided by operating activities for the nine months ended September 30, 2026, primarily consisted of net income of $156.1 million adjusted for non-cash items of $28.0 million related to stock-based compensation expense, $57.0 million related to acquired IPR&D, $17.9 million related to intangible amortization and depreciation, offset by $11.7 million related to deferred tax assets. Net working capital excluding cash increased by $51.3 million, primarily driven by increases in accounts receivable due to higher net product revenue in the current period and a decrease in accounts payable due to the timing of payments offset by higher accrued expenses including accrued royalties and accrued milestone payments.

Previous wording

Net cash provided by operating activities for the six months ended June 30, 2025, primarily consisted of net income of $85.3 million adjusted for non-cash items of $23.8 million related to stock-based compensation expense, $15.0 million related to acquired IPR&D and $11.9 million related to intangible amortization and depreciation, partially offset by $10.8 million related to deferred tax assets. Net working capital excluding cash increased by $12.4 million, primarily driven by increases in accounts receivable due to higher net product revenue in the current period and an increase in accounts payable due to the timing of payments.

Current wording

and depreciation, offset by $14.7 million related to deferred tax assets. Net working capital excluding cash decreased by $17.8 million, primarily driven by increases in accounts receivable due to higher net product revenue in the current period, offset by an increase in accounts payable due to the timing of payments and an increase in accrued expenses primarily from higher accrued rebates.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2026, was $315.1 million, which was primarily attributable to $331.5 million in purchases of debt securities and $32.0 million in upfront license fees related to new license agreements, offset by $48.4 million from maturities of investments.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2026, was $307.5 million, which was primarily attributable to $369.9 million in purchases of debt securities and $32.0 million in upfront license fees related to new license agreements, offset by $94.5 million from maturities of investments.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2025, was $17.2 million, which was primarily attributable to $43.0 million in purchases of debt securities, a $15.0 million upfront fee paid to CiRC and $0.1 million in purchases of property and equipment, partially offset by $40.9 million from maturities of investments.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025, was $22.0 million, which was primarily attributable to $67.3 million in purchases of debt securities, a $15.0 million upfront fee paid to CiRC and $0.2 million in purchases of property and equipment, partially offset by $60.5 million from maturities of investments.

Previous wording

Net cash used in financing activities for the six months ended June 30, 2026, was $7.8 million, which primarily consisted of $10.0 million in principal payments associated with the TLA Credit Agreement and $3.6 million of employee withholding tax payments related to stock-based awards, partially offset by $5.9 million in proceeds from the exercise of stock options.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026, was $5.2 million, which primarily consisted of $23.8 million in proceeds from the exercise of stock options, partially offset by $15.0 million in principal payments associated with the TLA Credit Agreement and $3.6 million of employee withholding tax payments related to stock-based awards.

Previous wording

Net cash used in financing activities for the six months ended June 30, 2025, was $3.0 million, which primarily consisted of $7.5 million in principal payments associated with the TLA Credit Agreement and $2.3 million of employee withholding tax payments related to stock-based awards, partially offset by $6.8 million in proceeds from the exercise of stock options.

Current wording

Net cash used in financing activities for the nine months ended September 30, 2025, was $6.0 million, which primarily consisted of $11.3 million in principal payments associated with the TLA Credit Agreement and $2.3 million of employee withholding tax payments related to stock-based awards, partially offset by $7.6 million in proceeds from the exercise of stock options.

Previous wording

Product revenue is recorded at the product’s list price and is reduced from the product’s list price at the time of recognition for variable consideration that is offered within contracts between us and our customers, payors, and other indirect customers relating to the sale of WAKIX. Components of variable consideration include government (as detailed below) and commercial contracts, commercial co-payment assistance program, and distribution service fees. These deductions are based on the amounts earned, or to be claimed on the related sales, and are classified as a current liability or reduction of receivables in our condensed consolidated balance sheet.

Current wording

Product revenue is recorded at the product’s list price and is reduced from the product’s list price at the time of recognition for variable consideration that is offered within contracts between us and our customers, payors, and other indirect customers relating to the sale of WAKIX. Components of variable consideration include government (as detailed below) and commercial contracts, commercial co-payment assistance program, and distribution service fees. These deductions are based on the amounts earned, or to be claimed

Previous wording

The following table provides a summary of activity and ending balances of our sales allowances and accruals for the six months ended June 30, 2026 (in thousands):

Current wording

The following table provides a summary of activity and ending balances of our sales allowances and accruals for the nine months ended September 30, 2026 (in thousands):