Harmony Biosciences Holdings, Inc. (HRMY): Business Model Canvas [Dec-2025 Updated]

You're digging into a biotech that bucks the trend: Harmony Biosciences is a profitable, self-funding operation, which, frankly, is rare. Their Q3 2025 numbers confirm this, showing a company guiding for net revenue between $845 million and $865 million this year, all anchored by WAKIX. But the real strategic play, the one that matters for the long haul, is how they are using that significant cash pile-over $778.4 million as of Q3-to aggressively build out a multi-franchise neuroscience pipeline. I've mapped out the nine essential components of this business model below so you can see exactly how they are turning a single successful drug into a sustainable, multi-asset platform.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Key Partnerships

You're looking at how Harmony Biosciences Holdings, Inc. builds value through its external relationships, which is critical since its primary revenue driver, WAKIX, relies on a foundational license. These alliances are the backbone for both current success and future pipeline expansion.

Exclusive U.S. license for WAKIX (pitolisant) from Bioprojet

Harmony Biosciences Holdings, Inc. operates under an exclusive license agreement with Bioprojet, based in France, for the development, manufacture, and commercialization of pitolisant, marketed as WAKIX, within the United States and its territories. This partnership is foundational, as WAKIX is Harmony Biosciences Holdings, Inc.'s only currently marketed product. The initial 2017 License and Commercialization Agreement (LCA) involved significant upfront and milestone payments to Bioprojet. Harmony Biosciences Holdings, Inc. has successfully navigated the required milestones, leading to substantial revenue generation from WAKIX as of late 2025.

Here's a look at the key financial commitments made to Bioprojet related to the WAKIX license:

The commercial success of WAKIX directly reflects on these partnership terms. For instance, WAKIX net revenue for the first quarter of 2025 reached $184.7 million, marking a 20% growth year-over-year. By the second quarter of 2025, net product revenue hit $200.5 million. This momentum continued into the third quarter, with WAKIX generating $239.5M in revenue, a 29% increase year-over-year, driven by approximately 500 new patients added that quarter. Harmony Biosciences Holdings, Inc. recently raised its full-year 2025 net revenue guidance to between $845 million and $865 million. The company is actively working to extend market exclusivity beyond the anticipated Q1 2030 loss of exclusivity, potentially to Q3 2030, through new formulations like Pitolisant Gastro-Resistant (GR) and high-dose (HD) versions. The utility patents filed for these formulations offer potential patent protection until 2044. That's a smart move to protect that revenue stream.

Research collaboration with CiRC Biosciences for refractory epilepsy

Harmony Biosciences Holdings, Inc. established a research collaboration with CiRC Biosciences to develop novel regenerative cellular therapies targeting serious, refractory neurological disorders. This partnership specifically targets refractory epilepsy and treatment-resistant narcolepsy. The upfront investment to start this collaboration was $15 million, paid to CiRC upon closing the agreement in 2025. This deal structure includes options for Harmony Biosciences Holdings, Inc. to acquire exclusive licenses for each program developed.

The financial terms for securing the license options are structured as follows:

• Option to acquire an exclusive license for each program (refractory epilepsy and treatment-resistant narcolepsy) after establishing preclinical in vivo proof of concept.
• Aggregate of $10 million in milestone and option fee payments for each program.
• Customary future milestones and royalties based on continued development and commercialization.

The refractory epilepsy pipeline asset stemming from this work, EPX-200 (lorcaserin hydrochloride), is currently in the IND-enabling stage as of late 2025. The related program for Fragile X Syndrome (FXS), ZYN002, had its Phase 3 RECONNECT study recruitment completed, with topline data anticipated in Q3 2025. The company also plans to initiate a Phase 3 registrational trial in 22q deletion syndrome in Q4 2025, further leveraging its epilepsy/neurobehavioral franchise expertise.

Strategic alliances with academic and research institutions for pipeline development

Beyond the direct licensing and specific research collaborations, Harmony Biosciences Holdings, Inc. utilizes strategic alliances, often rooted in academic or specialized research platforms, to fuel its pipeline. For example, the development of EPX-100 (clemizole hydrochloride), targeting Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), was based on a proprietary phenotype-based zebrafish drug screening platform. This platform uses scn1Lab mutant zebrafish models to screen compounds that modulate Nav1.1 in the central nervous system, which directly replicates the genetic etiology of DS.

Key pipeline assets linked to these research foundations include:

• EPX-100 (clemizole hydrochloride): Phase 3 ARGUS (DS) and LIGHTHOUSE (LGS) registrational trials are ongoing, with topline data anticipated in 2026 from both studies.
• BP1.15205 (Orexin-2 receptor agonist): The first-in-human study was set to commence in the second half of 2025, with clinical data expected in 2026. This asset is positioned as a potential best-in-class molecule based on preclinical data presented at SLEEP 2025.

Harmony Biosciences Holdings, Inc. has a stated goal to launch new products or indications each year, meaning these foundational research partnerships are essential for providing the next wave of assets beyond WAKIX. Finance: draft 13-week cash view by Friday.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Key Activities

You're looking at the core engine driving Harmony Biosciences Holdings, Inc. (HRMY) right now-the day-to-day work that turns pipeline potential into revenue. It's a focused set of activities centered on maximizing the current product and aggressively building out the next wave of potential blockbusters. Here's the breakdown of what the team is actively doing as of late 2025.

Commercialization and sales of WAKIX (pitolisant) in the U.S.

The primary activity is driving the commercial success of WAKIX (pitolisant) for narcolepsy. This means ensuring the sales force is effective in reaching the diagnosed U.S. narcolepsy market, which is estimated at approximately 80,000 patients. The momentum is strong; in the third quarter of 2025, Harmony Biosciences Holdings, Inc. reported net product revenue of $239.5 million, marking a 29% year-over-year growth for the WAKIX franchise.

This growth is fueled by patient uptake. The average number of patients on WAKIX reached approximately 8,100 in Q3 2025, following the highest quarterly increase on record of approximately 500 new average patients during that quarter. Based on this performance, Harmony Biosciences Holdings, Inc. recently raised its full-year 2025 net revenue guidance to a range of $845-$865 million. To support this, the company maintained a significant cash position, holding $778.4 million in cash, cash equivalents, and investments as of September 30, 2025. WAKIX is approved for excessive daytime sleepiness (EDS) and cataplexy in adults, and EDS in pediatric patients aged six years of age and older with narcolepsy.

Extensive Research and Development (R&D) for next-generation pitolisant (HD, GR)

Harmony Biosciences Holdings, Inc. is heavily investing in extending the life and reach of the pitolisant molecule through next-generation formulations. This R&D focus requires substantial financial commitment; for instance, Research and Development expenses hit $55.0 million in the third quarter of 2025.

Key development tracks include:

• The Pitolisant GR (gastro-resistant) formulation, which had its pivotal bioequivalence study readout anticipated in the third quarter of 2025.
• The Pitolisant HD (high-dose) formulation, where the company is on track to initiate a Phase 3 registrational trial for idiopathic hypersomnia (IH) in the fourth quarter of 2025.

The company is building a strong intellectual property moat, with preliminary IP filed out to 2044 for the pitolisant franchise.

Advancing late-stage pipeline assets like EPX-100 and BP1.15205

Beyond pitolisant, the key activity involves advancing assets acquired through strategic moves into rare epilepsies and novel sleep mechanisms. Harmony Biosciences Holdings, Inc. anticipates having up to six Phase 3 clinical development programs by the end of 2025, with the pipeline having the potential to generate over $3 billion in net revenue.

You can track the progress of these late-stage assets here:

The advancement of BP1.15205 into clinical development is a major focus, as it is an investigational, potentially best-in-class OX2R agonist.

Managing regulatory filings, including sNDA for pitolisant in idiopathic hypersomnia

Managing the regulatory pathway for new indications is a critical, high-stakes activity. Harmony Biosciences Holdings, Inc. faced a setback when the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter in February 2025 for the initial supplemental New Drug Application (sNDA) for pitolisant in idiopathic hypersomnia (IH).

The response to this has been to pivot the IH strategy, which is a defintely important move:

• The company is focusing its IH efforts on the Pitolisant HD formulation, which is believed to have a more significant opportunity due to its optimized profile.
• The planned Phase 3 registrational trial for Pitolisant HD in IH is on track to start in the fourth quarter of 2025.
• The target Prescription Drug User Fee Act (PDUFA) date for this new trial is set for 2028.

This regulatory navigation directly impacts the timeline for accessing the IH market opportunity.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Key Resources

You're looking at the core assets Harmony Biosciences Holdings, Inc. is using to drive its business right now, late in 2025. It's a mix of proprietary science, serious capital, and a focused sales engine.

WAKIX (pitolisant) drug asset and its intellectual property form the bedrock. Harmony has aggressively defended this asset, securing a settlement with Lupin Limited that licenses generic entry no earlier than January 2030, or potentially July 2030 with pediatric exclusivity. Furthermore, next-generation formulations like Pitolisant HD are protected by utility patents extending exclusivity out to 2044. This IP moat is a massive resource for long-term revenue stability.

The financial strength is clear, with Harmony ending Q3 2025 in a very comfortable spot. This capital provides the flexibility to fund late-stage programs and pursue business development. It's a self-funding biotech profile, which is rare.

The late-stage, multi-franchise neuroscience pipeline represents future value creation, moving beyond the core WAKIX narcolepsy indication. Harmony is on track to initiate Phase 3 trials for pitolisant HD in both narcolepsy and idiopathic hypersomnia in Q4 2025. The company has positioned itself for up to five Phase 3 programs by the end of 2025.

• Pitolisant Gastro-Resistant (GR) topline data expected in Q4 2025.
• EPX-100 Dravet Syndrome (DS) Phase 3 topline data expected in 2026.
• BP1.15205 (Orexin 2 Agonist) on track to dose first subject in Q4 2025.

For the specialized commercial sales force, the resource is the established infrastructure built around WAKIX. As of Q1 2025, the company was calling on approximately 9,000 HCPs (Health Care Professionals), with about 5,000 of those not using an oxybate REMS program. This existing footprint is critical for launching new indications like pitolisant HD.

Here's a look at the commercial investment supporting this resource base, based on early 2025 spending:

The ability to generate $239.5 million in net product revenue in Q3 2025, driven by approximately 8,100 average patients on WAKIX, shows this commercial engine is running hot. That execution fuels the entire resource base.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Value Propositions

You're looking at the core value Harmony Biosciences Holdings, Inc. delivers to the market, which is built on a foundation of unique product positioning and a clear pipeline strategy. The numbers show a company executing on its primary asset while aggressively building out its future franchises.

WAKIX: Only FDA-approved, non-scheduled treatment for narcolepsy

The primary value proposition centers on WAKIX (pitolisant) being the only FDA-approved treatment for narcolepsy that is not a controlled substance by the U.S. Drug Enforcement Administration. This non-scheduled status is a significant differentiator for prescribers managing patients who need wake-promoting therapy without the associated regulatory or abuse-potential concerns of stimulants.

The commercial traction supports this unique positioning. For the third quarter of 2025, WAKIX franchise net revenue hit approximately $239 million, marking a 29% year-over-year growth rate. Management has since raised the full-year 2025 net revenue guidance to a range of $845 million to $865 million. Honestly, the goal is clear: WAKIX is on track to achieve $1 billion plus in annual revenue from narcolepsy alone, well before its loss of exclusivity in 2030.

Addresses excessive daytime sleepiness and cataplexy in narcolepsy patients

WAKIX provides therapeutic value by treating both cardinal symptoms of narcolepsy. The drug was initially approved for excessive daytime sleepiness (EDS) in adults in 2019, followed by approval for cataplexy in adults in 2020. Furthermore, in June 2024, approval extended to pediatric patients aged 6 years and older for EDS, making it the first non-scheduled treatment option for that age group. The growth in patient base reflects this broad utility.

Here's the quick math on patient adoption through Q3 2025:

What this estimate hides is the sustained demand across different patient segments, but the trend shows accelerating adoption, which is what you want to see in a flagship product.

Pipeline: Potential first-approved therapies for rare neurological disorders

Harmony Biosciences Holdings, Inc. is leveraging its expertise to expand beyond narcolepsy into other rare neurological disorders, aiming to deliver potentially first-approved therapies. This pipeline diversification is key to long-term value creation.

• Fragile X Syndrome (FXS): The ZYN002 Phase 3 RECONNECT study is targeting topline data readout in Q3 2025. This represents an opportunity to treat approximately 80,000 patients in the US with what could be the first-and-only approved drug for FXS, with Harmony holding global rights.
• Dravet Syndrome (DS) & Lennox-Gastaut Syndrome (LGS): The EPX-100 program has Phase 3 registrational trials ongoing (ARGUS for DS, LIGHTHOUSE for LGS), with topline data anticipated in 2026.
• 22q Deletion Syndrome: The company planned to initiate a Phase 3 registrational trial in Q4 2025.

Next-gen formulations (HD, GR) for improved efficacy and patient convenience

To extend the life cycle of the core pitolisant molecule, Harmony is advancing next-generation formulations designed for improved patient convenience and potentially broader indications. These life-cycle management programs are designed to extend franchise growth well into the mid-2040s, supported by utility patents filed through 2044.

The progress on these formulations is concrete:

• Pitolisant HD (High-Dose): Phase III registrational trials in both narcolepsy and idiopathic hypersomnia (IH) are on track to initiate in Q4 2025, with target PDUFA dates set for 2028. The HD formulation targets enhanced efficacy for EDS and a differentiated label for fatigue in narcolepsy.
• Pitolisant GR (Gastro-Resistant): This formulation recently reported positive pivotal bioequivalence results, confirming equivalence to existing WAKIX tablets. This supports an expected New Drug Application (NDA) filing in early 2026, with a potential review decision in the first quarter of 2027. The GR topline data readout was anticipated in Q4 2025.

The company's financial position supports this development, reporting cash, cash equivalents, and investments of $778.4 million as of September 30, 2025. Finance: draft 13-week cash view by Friday.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Customer Relationships

You're looking at how Harmony Biosciences Holdings, Inc. supports the specialists and patients who rely on their therapies, especially for rare neurological conditions. The relationship strategy centers on deep support for access and education, which is critical when dealing with specialized treatments like WAKIX®.

High-touch patient support programs for specialty drug access and adherence

Harmony Biosciences Holdings, Inc. focuses on ensuring patients can access and stay on therapy. This is key since the U.S. narcolepsy market opportunity is estimated at approximately 80,000 diagnosed patients. The patient base for WAKIX® is growing steadily; the average number of patients on the drug increased to approximately 7,200 for the first quarter of 2025, exiting that quarter with about 7,300 patients. By the third quarter of 2025, the company reported its highest ever quarterly increase in the average number of patients, adding approximately 500 patients during that period alone. This high-touch approach also extends to new populations, as Harmony Biosciences expanded the availability of pitolisant therapy for pediatric narcolepsy patients across specialty sleep centers in October 2025. The company is projecting full year 2025 net product revenue for WAKIX® to fall between $820 million and $860 million.

The commitment to patient support is reflected in the company's overall structure, with total employees reported at 268 as of September 30, 2025.

Dedicated medical science liaisons (MSLs) for specialist education

Education for specialists is driven by the complexity of the science and the pipeline advancement. Harmony Biosciences Holdings, Inc. is pushing several late-stage programs that require deep scientific exchange with key opinion leaders. For instance, they anticipated topline data readout from the Phase 3 registrational trial with ZYN002 in Fragile X syndrome in the third quarter of 2025. Furthermore, they planned to initiate Phase 3 registrational trials with the next-generation Pitolisant HD formulation in both narcolepsy and idiopathic hypersomnia in the fourth quarter of 2025. The company is nurturing a future full of therapeutic possibilities, aiming to introduce at least one new product or indication annually through 2028.

Direct-to-physician engagement via a specialized commercial team

The commercial engagement strategy targets healthcare providers directly. During the second quarter of 2025, Harmony Biosciences Holdings, Inc.'s commercial efforts reached approximately 9,000 healthcare providers. A significant portion of this outreach focuses on prescribers outside of existing treatment paradigms, specifically reaching about 5,000 of those HCPs who do not participate in an oxybate REMS program. The investment in this direct engagement is substantial, with Sales and Marketing expenses reported at $30.7 million in the first quarter of 2025 and $29.5 million in the third quarter of 2025.

Here's a quick look at the key commercial and patient metrics as of the latest reported periods in 2025:

The company's strategy clearly ties commercial execution to patient outcomes, supported by broad payer coverage and how they support patients over time.

• Expanded WAKIX therapy availability to pediatric narcolepsy patients in October 2025.
• Anticipated topline data for ZYN002 (Fragile X Syndrome) in Q3 2025.
• Planned initiation of Pitolisant HD Phase 3 trials in narcolepsy and IH in Q4 2025.
• Utility patents filed for next-gen pitolisant formulations with potential protection until 2044.

Finance: review Q3 2025 Sales & Marketing spend against HCP reach to determine cost-per-touch effectiveness by end of year.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Channels

You're looking at how Harmony Biosciences Holdings, Inc. gets its product, WAKIX, to the patient and communicates with the market as of late 2025. The channels are all about precision delivery and clear, timely communication, which makes sense for a rare disease focus.

Specialty pharmacy network for drug distribution and patient services.

The distribution channel relies on a carefully managed specialty pharmacy network to handle the complexity of WAKIX (pitolisant) tablets and ensure patient support services are in place. This channel is critical for supporting the growing patient base, which reached an average of 8,100 patients in the third quarter of 2025. The success of this channel directly translates to the reported net product revenue of approximately $239.0 million for the third quarter of 2025. Harmony Biosciences Holdings, Inc. is clearly focused on a channel that can manage the logistics for a drug contributing to a raised full-year 2025 revenue guidance of $845-$865 million. In the broader industry context, manufacturers often select a limited or exclusive dispensing network for specialty drugs, which requires close management of these partners to maintain patient access and service quality.

The scale of the distribution effort can be seen in the quarterly patient additions:

• Highest ever quarterly increase in average number of patients: approximately 500 for Q3 2025.
• Average number of patients on WAKIX in Q3 2025: 8,100.
• Net product revenue for the nine months ended September 30, 2025: $639.5 million (calculated from Q3 $239.5M and nine-month $576.1M from 2024, using the provided Q3 data for context, though the exact nine-month 2025 revenue is not explicitly stated as a sum, the Q3 result is the most concrete recent figure).

Dedicated commercial sales force targeting sleep disorder specialists and neurologists.

The commercial reach is executed by a dedicated sales force focused on prescribers in the relevant therapeutic areas. While the exact size of the sales force isn't public, the overall organization size gives you a sense of the infrastructure supporting this channel. Harmony Biosciences Holdings, Inc. reported a total employee count of 268 as of late 2025. This team drives the prescription volume that resulted in a 29% year-over-year revenue growth for the WAKIX franchise in Q3 2025. The sales effort is geared toward specialists who treat narcolepsy, the primary indication for WAKIX.

Here's a look at the financial scale underpinning the commercial operations:

Investor relations and public relations for market communication.

Market communication is managed through formal investor relations and public relations activities, which are essential for a publicly traded company with a market capitalization around $1.64 billion (as of October 31, 2025) or approximately $1.69 billion (as of November 4, 2025). These channels ensure timely disclosure of operational and financial milestones to the investment community.

Key communication events in late 2025 included:

• Third Quarter 2025 Financial Results Conference Call: November 4, 2025, at 8:30 a.m. Eastern time.
• Stock Price (October 31, 2025): $28.57.
• 2025 Revenue Guidance Range: $845 million to $865 million.
• Webcast availability for investor calls: https://ir.harmonybiosciences.com/.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Customer Segments

You're looking at the core audience Harmony Biosciences Holdings, Inc. (HRMY) targets with its therapies, primarily WAKIX (pitolisant). The focus is clearly on the narcolepsy market, but the company is actively building out its presence in other rare neurological spaces.

The primary segment is U.S. patients diagnosed with narcolepsy. The total addressable population is substantial, with estimates pointing to approximately 80,000 diagnosed patients in the U.S.. Harmony Biosciences Holdings, Inc. is capturing a growing share of this population with WAKIX. As of the third quarter of 2025, the average number of patients on WAKIX reached 8,100. This represented a quarterly increase of about 500 average patients, the highest quarterly addition since launch. The company projects WAKIX will achieve $1 billion plus in annual revenue in narcolepsy alone, well ahead of its loss of exclusivity in 2030.

The second key segment involves the prescribing physicians. These are the specialists who manage narcolepsy and related disorders. Harmony Biosciences Holdings, Inc. focuses its commercial efforts on this group, calling on approximately 9,000 Healthcare Professionals (HCPs). A specific point of differentiation is that about 5,000 of these HCPs do not participate in an oxybate REMS (Risk Evaluation and Mitigation Strategy) program, highlighting a segment where WAKIX's non-scheduled status offers a clear advantage. The primary prescribers are sleep specialists and neurologists.

The third segment targets patients with rare neurological diseases. Harmony Biosciences Holdings, Inc. is actively expanding into these areas through its pipeline. For instance, pitolisant is being developed for excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH), with Phase III registrational trials on track for initiation in the fourth quarter of 2025 and a PDUFA target in 2028. Furthermore, the company is pursuing ZYN002 for Fragile X syndrome (FXS), a condition impacting approximately 80,000 U.S. families.

Here's a quick look at the patient and revenue metrics driving this segment focus as of late 2025:

The company's commercial execution is supported by strong access; payer coverage for WAKIX is reported at >80% of lives.

You should note the specific indications driving the current patient base:

• WAKIX for excessive daytime sleepiness (EDS) or cataplexy in adult narcolepsy patients.
• WAKIX for EDS in pediatric narcolepsy patients aged 6 years and older.
• Pipeline focus on IH and FXS for future patient acquisition.

Finance: draft 13-week cash view by Friday incorporating Q3 revenue run-rate.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Cost Structure

You're looking at where Harmony Biosciences Holdings, Inc. is spending its money to keep WAKIX growing and to push its pipeline forward. Honestly, for a company this size, the cost structure is heavily weighted toward commercial execution and future development.

Significant investment in Research and Development (R&D) for pipeline expansion

Research and Development spending is clearly a major cost driver as Harmony Biosciences Holdings, Inc. advances its late-stage pipeline. You see this investment reflected in the figures from the third quarter of 2025. R&D expenses hit $55.0 million for Q3 2025, which was a massive 117% increase compared to the same quarter in 2024, which saw R&D at $25.4 million.

This R&D spend isn't just routine; it's funding significant pipeline advancement. Management expects to have five ongoing Phase III registrational programs by the end of 2025, including starting two Phase III studies for the Pitolacin HD programs. Also, they expected a milestone payment of $4,000,000 for the initiation of a Phase I trial in their orexin-two agonist program.

The Q3 2025 R&D figure was specifically impacted by a $15.0 million IPR&D charge related to a clinical milestone achieved for ZYN002. The company is positioning itself for future revenue by investing heavily now.

Selling, General, and Administrative (SG&A) costs for WAKIX commercialization

Commercializing WAKIX requires substantial SG&A investment to reach prescribers and patients. For the third quarter of 2025, the combined SG&A components show the ongoing cost of supporting the flagship product. It's a significant, but controlled, expense category.

Here's a quick look at the components for Q3 2025, based on the reported figures:

To give you more context on the operational spend, here's how the total operating expenses looked in the preceding quarter:

• Total Operating Expenses in Q3 2025 were $114.3 million.
• Total Operating Expenses in Q2 2025 were $114.2 million.
• Total Operating Expenses in Q2 2025 represented a 4.3% decrease versus Q2 2024.

Milestone payments for in-licensed assets, like the $15 million for CiRC collaboration

Harmony Biosciences Holdings, Inc. uses upfront payments and milestone obligations to secure access to promising assets. The CiRC Agreement, entered into in June 2025, is a clear example of this strategy in action.

The upfront fee paid to CiRC Biosciences, Inc. under this research collaboration, option and license agreement was $15.0 million. This payment was made in the second quarter of 2025.

It's worth noting that another significant, non-cash charge impacting R&D in Q3 2025 was also $15.0 million, tied to a ZYN002 clinical milestone. This shows how milestone-based payments, whether cash or non-cash accounting charges, are a key part of the cost structure when advancing partnered assets.

Manufacturing and distribution costs for WAKIX

Specific line-item data for 'Manufacturing and distribution costs' for WAKIX isn't explicitly broken out in the high-level Q3 2025 summaries you have access to. However, these costs are embedded within the overall Cost of Goods Sold (COGS) and operating expenses necessary to support the growing commercial base.

The cost to deliver WAKIX is managed alongside the commercialization efforts, which saw Sales and Marketing expenses at $29.5 million in Q3 2025. The company is focused on scaling production to meet demand, as the average patient count reached a record 8,100 in Q3 2025, up by approximately 500 patients from the prior quarter.

The company's ability to generate strong cash flow-increasing by $106 million in Q3 2025 to reach $778 million in cash, cash equivalents, and investments-suggests that manufacturing and distribution costs are being effectively managed relative to the growing net product revenue, which was $239.5 million in Q3 2025.

Finance: draft 13-week cash view by Friday.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Harmony Biosciences Holdings, Inc.'s current financial performance, which is heavily concentrated on one key asset right now. The revenue streams are straightforward, built almost entirely on prescription drug sales, with future potential layered on top.

Net product revenue from sales of WAKIX (pitolisant) in the U.S. is the foundation. This is the money coming in from WAKIX for treating excessive daytime sleepiness and cataplexy in narcolepsy patients. The growth here is what dictates the near-term outlook for Harmony Biosciences Holdings, Inc. For instance, in the third quarter of 2025, the WAKIX franchise delivered net revenue of approximately $239 million. That figure compares to $186 million for the same period in 2024, showing a year-over-year growth of 29%.

Here's a quick look at how the primary revenue driver performed in Q3 2025, which informs the full-year expectation:

The company's confidence in this trajectory led to an upward revision of the Full-year 2025 net revenue guidance. The current projection sits in the range of $845 million to $865 million, adjusted from the prior range of $820 million to $860 million. Honestly, you watch that guidance range closely; it's the clearest signal of commercial execution.

Harmony Biosciences Holdings, Inc. is also building out secondary revenue potential, though these are not the primary drivers today:

• Potential future milestone and royalty revenue from out-licensing: This is secondary, tied to agreements for products outside the U.S. or for specific indications where Harmony has partnered.
• Future product sales from pipeline launches: This represents significant upside. The pipeline is designed to deliver new product or indication approvals annually through 2028.

The pipeline is where the long-term revenue story develops beyond WAKIX monotherapy in narcolepsy. You should track these specific pipeline developments as they represent future revenue streams:

• Pitolisant HD for narcolepsy (launch of pivotal Phase 3 trial anticipated in Q4 2025).
• EPX-100 for Lennox-Gastaut syndrome (LGS) (pivotal Phase 3 trial initiated in Q4 2024).
• BP1.15205 (an Orexin/OX2R agonist).

The long-term vision, as stated by management, is building a company with the potential to deliver over $3 billion in net revenue going forward, leveraging these pipeline assets alongside WAKIX.

Finance: draft 13-week cash view by Friday.