Vanda Pharmaceuticals Inc. (VNDA): Business Model Canvas [Dec-2025 Updated]

You're looking at Vanda Pharmaceuticals Inc., trying to figure out if their focused bet on CNS and rare disease drugs is paying off, and frankly, it's a tightrope walk. Their current structure is built around commercializing Fanapt, HETLIOZ, and PONVORY, all while managing significant R&D costs and defending intellectual property, all supported by a cash position of $293.8 million as of September 30, 2025. It's a classic specialty pharma pivot: defend the cash cows while pushing near-term pipeline milestones, but that expansion shows up in high Selling, General & Administrative expenses, hitting $64.6 million in Q2 2025. I've broken down their entire Business Model Canvas below, showing you exactly where the money is going and what value they are delivering to prescribers and patients-you'll want to see the details on their key partnerships and the revenue breakdown from Q3 2025.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Key Partnerships

You're looking at the critical external relationships Vanda Pharmaceuticals Inc. relies on to get its products to market and manage its intellectual property defense. These partnerships are the backbone for commercial reach and legal security, so let's look at the hard numbers we have as of late 2025.

Collaborative framework with the U.S. Food and Drug Administration (FDA) for regulatory dispute resolution

Vanda Pharmaceuticals Inc. formalized a key working relationship with the U.S. Food and Drug Administration (FDA) to address ongoing regulatory matters. This framework was agreed upon on October 1, 2025.

• The agreement specifically targets disputes concerning HETLIOZ (tasimelteon) and tradipitant.
• A concrete action under this framework involves the FDA conducting an expedited re-review of the partial clinical hold on tradipitant for motion sickness, with a target date of November 26, 2025.

Third-party manufacturers for drug supply and production

Vanda Pharmaceuticals Inc. depends on external entities for the physical production of its medicines. While specific contract values aren't public for all, the nature of the supply chain is categorized under specific industry codes.

Exclusive commercialization partners in international markets like Probiomed (Mexico) and Megapharm (Israel)

For markets outside the U.S., Vanda Pharmaceuticals Inc. utilizes established local partners to handle commercialization efforts. Specific revenue contributions from these partners for 2025 are not publicly itemized in the latest reports, but the overall HETLIOZ performance gives context to the market these partners operate in.

• Partnering for international market access includes entities such as Probiomed (Mexico) and Megapharm (Israel).
• HETLIOZ net product sales for the first nine months of 2025 totaled $55.0 million.
• HETLIOZ net product sales for the third quarter of 2025 were $18.0 million.

Licensing agreements with generic manufacturers like MSN Pharmaceuticals to manage patent litigation

Managing patent risk is a significant partnership function, exemplified by the settlement with MSN Pharmaceuticals Inc. and Impax Laboratories LLC regarding generic HETLIOZ. This agreement secures a defined entry date for generic competition.

The settlement resolved litigation over a product that represented a major share of Vanda Pharmaceuticals Inc.'s revenue stream at the time of the 2022 agreement. The company's overall 2025 revenue guidance is between $210 million and $230 million.

Contracts with the U.S. Department of Veterans Affairs (VA) for HETLIOZ supply

Direct supply contracts with federal entities like the Department of Veterans Affairs (VA) represent a stable, albeit smaller, revenue component. The contract for HETLIOZ - BULK was active for the 2025 fiscal year period.

The VA contract is classified under Product or Service Code 6505: DRUGS AND BIOLOGICALS. Vanda Pharmaceuticals Inc.'s year-end 2025 cash guidance is set between $260 million and $290 million.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Key Activities

Commercialization and marketing of Fanapt, HETLIOZ, and PONVORY

Vanda Pharmaceuticals Inc.'s commercial activity in late 2025 was heavily weighted toward Fanapt growth, while managing HETLIOZ against generic pressure and advancing PONVORY market penetration.

For the third quarter of 2025, total net product sales from Fanapt, HETLIOZ, and PONVORY reached $56.3 million, marking an 18% increase compared to $47.7 million in the third quarter of 2024.

The breakdown of Q3 2025 net product sales was:

Fanapt total prescriptions (TRx) increased by 35% year-over-year in the third quarter of 2025. For the first nine months of 2025, total revenues were $158.9 million, a 9% increase over the first nine months of 2024.

Vanda Pharmaceuticals Inc. narrowed its full-year 2025 total revenue guidance for these products to between $210 million and $230 million.

Research and development (R&D) for pipeline candidates (e.g., Bysanti, tradipitant, imsidolimab)

R&D spending reflects active development across the pipeline, including the advancement of Bysanti, tradipitant, and imsidolimab. Research and development costs for the second quarter of 2025 were $21.99 million, a 32% increase compared to Q2 2024. For the first nine months of 2025, R&D expenses totaled $80.265 million, up from $54.591 million for the same period in 2024.

Key pipeline activities include:

• Bysanti (milsaperidone) Phase III for major depressive disorder (MDD) is enrolling, with results expected in 2026.
• The Fanapt Long Acting Injectable (LAI) Phase III program is currently enrolling patients.
• The clinical study of tradipitant for the prevention of vomiting induced by a GLP-1 analog has completed, with results expected in the fourth quarter of 2025.

Regulatory affairs management for multiple PDUFA dates in late 2025/early 2026

Management's key activity centers on navigating several critical Prescription Drug User Fee Act (PDUFA) target action dates.

Upcoming regulatory milestones as of late 2025:

• Tradipitant NDA for motion sickness: PDUFA target action date of December 30, 2025. Formal labeling discussions have commenced.
• Bysanti NDA for bipolar I disorder and schizophrenia: PDUFA target action date of February 21, 2026.
• HETLIOZ Supplemental NDA (sNDA) for jet lag disorder re-review expected by January 7, 2026.
• Imsidolimab Biologics License Application (BLA) for generalized pustular psoriasis (GPP) is expected to be submitted in the fourth quarter of 2025.

Expanding commercial infrastructure and direct-to-consumer (DTC) brand campaigns

Commercial infrastructure expansion is evidenced by sales force growth and increased Selling, General, and Administrative (SG&A) expenses. The Fanapt sales force expanded to approximately 300 reps by mid-2025.

SG&A expenses for the first six months of 2025 were $114.7 million, compared to $69.559 million for the same period in 2024. For Q3 2025, operating expenses were $87.5 million, up from $58.7 million a year earlier, mainly due to higher SG&A and R&D.

The direct-to-consumer campaign, launched in the first quarter of 2025, continued to drive gains in brand awareness for Fanapt and PONVORY.

Intellectual property defense and patent lifecycle management

Vanda Pharmaceuticals Inc. is actively managing patent life to secure future revenue streams for its key assets.

Patent exclusivity timelines include:

• Bysanti patent protection is targeted into the 2040s.
• Pending patent applications for the Fanapt LAI formulation could extend exclusivity into the 2040s.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Key Resources

You're looking at the core assets Vanda Pharmaceuticals Inc. is using to drive its business right now, late in 2025. These aren't just line items; they are the tangible and intangible things the company relies on to create value.

Commercial Products

Vanda Pharmaceuticals Inc. has three key commercial products supporting its current operations: Fanapt, HETLIOZ, and PONVORY. Fanapt, in particular, is showing strong growth momentum, largely due to the expanded sales force and its launch for Bipolar I disorder in April 2024.

Here's a look at the net product sales performance through the third quarter of 2025:

The total net product sales for the first nine months of 2025 reached $158.9 million, which was a 9% increase compared to the same period in 2024. Still, HETLIOZ sales face ongoing generic competition, which management notes could lead to future declines.

Financial Assets

Liquidity remains a core resource. As of September 30, 2025, Vanda Pharmaceuticals Inc. reported cash, cash equivalents, and marketable securities totaling $293.8 million. This figure represents a decrease of $31.8 million compared to June 30, 2025, reflecting investments in R&D and commercial activities. The company also noted it has no debt as of the third quarter of 2025.

Intellectual Property

Protecting the revenue streams from existing products is critical. Vanda Pharmaceuticals Inc. holds intellectual property protecting HETLIOZ until at least February 2035, based on specific US drug patents for highly purified pharmaceutical grade tasimelteon. While some sources estimate a generic launch around February 21, 2041, based on the combination of all patents and exclusivities, the February 2035 date is a concrete patent protection point you should track.

Specialized Sales Force

The commercial engine is powered by a growing team. The specialized sales force for Vanda Pharmaceuticals Inc. was expanded to approximately 300 representatives by mid-2025. This expansion was heavily focused on Fanapt, with the dedicated sales force growing from about 50 representatives in Q1 2024 to approximately 250 currently, aiming for that 300-rep mark to support sequential prescription growth.

Late-Stage Clinical Pipeline Assets

Future value is tied up in the pipeline assets moving through late-stage development. These represent potential new revenue streams contingent on regulatory success:

• Bysanti (milsaperidone): NDA under review for acute bipolar I disorder and schizophrenia, with a PDUFA target action date expected on February 21, 2026.
• Tradipitant: NDA for motion sickness has a PDUFA target action date of December 30, 2025. Results from the Phase 2 study on prevention of vomiting in GLP-1 analog patients are expected in Q4 2025.
• Imsidolimab: A Biologics License Application (BLA) for Generalized Pustular Psoriasis (GPP) is anticipated to be submitted to the FDA by year-end 2025.

Finance: draft 13-week cash view by Friday.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Value Propositions

You're looking at the core things Vanda Pharmaceuticals Inc. (VNDA) offers to its customers-the distinct benefits its approved drugs and pipeline candidates bring to patients and the market. It's all about solving real, tough problems in psychiatry and neurology.

Fanapt is a key value driver, offering treatment for schizophrenia and bipolar I disorder. The commercial momentum is clear; for the third quarter of 2025, Fanapt net product sales hit $31.2 million, which is a 31% jump compared to the third quarter of 2024. That growth is fueled by strong adoption, with total prescriptions (TRx) increasing by 35% year-over-year in Q3 2025. For the first nine months of 2025, Fanapt sales reached $84.1 million, up 24% from the prior year period. Plus, Vanda is pushing for broader use, as the New Drug Application (NDA) for Bysanti (milsaperidone) for bipolar I disorder and schizophrenia has an FDA target action date of February 21, 2026.

HETLIOZ provides a unique value proposition as a treatment for Non-24-Hour Sleep-Wake Disorder (Non-24) in blind adults. This addresses a very specific, often overlooked, patient population. While facing generic competition, HETLIOZ delivered Q3 2025 net product sales of $18.0 million, showing a slight 1% increase year-over-year. For the first nine months of 2025, sales were $55.0 million, a small 3% dip from the same period in 2024. Vanda is also pursuing expansion, with the FDA re-reviewing the supplemental NDA for jet lag disorder by January 7, 2026.

The pipeline offers significant optionality, especially with near-term regulatory milestones. The NDA for tradipitant for motion sickness has a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. This is potentially huge; tradipitant could be the first new pharmacologic treatment for motion sickness in over 40 years. Furthermore, the FDA lifted a partial clinical hold on a tradipitant study on December 4, 2025, allowing clinical investigations to continue. Also, the Biologics License Application (BLA) for imsidolimab for generalized pustular psoriasis is expected to be submitted in Q4 2025.

Vanda Pharmaceuticals Inc. focuses on addressing high unmet medical needs across psychiatry and neurology. This focus is what underpins the value of their portfolio, moving beyond crowded markets. The company's total net product sales from its three commercialized products reached $56.3 million in the third quarter of 2025, an 18% year-over-year increase. For the first nine months of 2025, total net product sales were $158.9 million. The company has narrowed its full-year 2025 revenue guidance to between $210 million and $230 million.

PONVORY provides an oral therapy option for relapsing multiple sclerosis (MS). While facing year-over-year pressure, sequential growth shows traction. Q3 2025 net product sales were $7.0 million, a 20% increase from Q3 2024. In the second quarter of 2025, sales were $7.1 million, marking a 26% sequential increase. The company is investing here, having expanded its PONVORY sales force to approximately 40 representatives as of Q1 2025.

Here's a quick look at the recent product sales performance:

The pipeline progression itself is a value proposition, signaling future revenue potential and addressing more unmet needs. Vanda's employee count surpassed 400 in Q1 2025, a 22-year high, indicating increased operational capacity to support these assets.

• Fanapt new patient starts (NBRx) increased by nearly threefold in Q1 2025 compared to Q1 2024.
• Tradipitant NDA PDUFA date is set for December 30, 2025.
• Bysanti NDA PDUFA date is set for February 21, 2026.
• Year-end 2025 cash guidance is projected between $260 million and $290 million.
• The company is strategically investing in commercial infrastructure, including targeted sponsorships.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Customer Relationships

You're building out the customer relationship strategy for Vanda Pharmaceuticals Inc. (VNDA) as we head into late 2025. This is all about how the company connects with the people who write the prescriptions and the patients who take the drugs. It's a high-touch approach, which you'd expect for specialty pharma.

Dedicated Specialty Sales Force for Direct Engagement with Prescribers

Vanda Pharmaceuticals Inc. has been aggressively scaling its direct engagement with prescribers, especially psychiatrists and neurologists, to support its commercial products like Fanapt. This isn't a small team; they've been building capacity to drive face-to-face interactions.

Here's the quick math on the sales force expansion supporting Fanapt, which launched for bipolar I disorder in April 2024:

The focus is definitely on driving prescription volume. Fanapt new-to-brand prescriptions (NBRx) increased by 147% in the third quarter of 2025 compared to the third quarter of 2024. This growth trajectory is directly tied to the expanded commercial capacity. They also use a broad speakers program to educate prescribers on Fanapt's profile. It's defintely a resource-intensive relationship strategy.

Direct-to-Consumer (DTC) Advertising Campaigns to Drive Brand Awareness

Vanda Pharmaceuticals Inc. is using DTC efforts to build brand awareness, which helps drive patients to ask their doctors about the products. This is a significant investment area, especially as they push for growth across their portfolio.

The DTC relationship-building efforts include:

• A broad direct-to-consumer brand awareness campaign that started in the first quarter of 2025.
• Elevating brand awareness for key products, specifically Fanapt and PONVORY.
• Maintaining strategic investments in commercial infrastructure, including increased brand visibility through targeted sponsorships.

While Vanda's specific 2025 DTC spend isn't itemized, the overall pharma industry is projected to spend approximately $10 billion globally on DTC advertising in 2025. Vanda's campaign is clearly a factor in the increased SG&A expenses noted in their operating costs.

Patient Access and Support Programs for High-Cost Specialty Drugs

For specialty drugs, the relationship extends past the prescription to ensuring the patient can actually start and stay on therapy. Vanda Pharmaceuticals Inc. supports this through established access programs for their commercialized products.

You can see this structure in their publicly available product information:

• HETLIOZAccess®: This is the company's Expanded Access Program for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults.
• Fanapt PAP: The company provides access to the Fanapt Patient Assistance Program (PAP) Enrollment Form.

These programs are critical for managing the patient journey, especially with high-cost therapies where insurance hurdles can be significant. Management has explicitly stated a focus on increasing access and affordability for patients.

Managed Care and Payer Relations to Ensure Formulary Access and Reimbursement

Securing favorable formulary placement with payers is a non-negotiable part of the specialty pharma customer relationship, as it directly impacts net revenue and patient access. Vanda Pharmaceuticals Inc. is actively managing this dynamic, particularly with recent legislative changes.

The key financial consideration here relates to the impact of government policy on their net realized prices:

Management has noted that the Medicare benefit redesign under the Inflation Reduction Act is anticipated to impact gross-to-net adjustments, which directly affects the net revenue captured from payers for both Fanapt and HETLIOZ.

The company's 2025 revenue guidance narrowing reflects this variability, which often stems from payer dynamics and inventory fluctuations. Finance: draft 13-week cash view by Friday.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Channels

Vanda Pharmaceuticals Inc. utilizes a multi-pronged channel strategy to bring its commercial products, including Fanapt®, HETLIOZ®, and PONVORY®, to market as of late 2025.

Specialty pharmacies and distributors for product fulfillment

The fulfillment channel for Vanda Pharmaceuticals Inc. products involves reliance on established specialty pharmacy and distributor networks. Performance in this channel is subject to inventory dynamics, as evidenced by HETLIOZ® net product sales of $18.0 million in the third quarter of 2025, which was impacted by inventory shifts at these partners. The U.S. specialty drug spending market, which these channels serve, was valued at approximately $129 billion in 2024, with forecasts implying nearly 40% annual growth. Vanda Pharmaceuticals Inc.'s total net product sales for the third quarter of 2025 reached $56.3 million.

Direct sales force targeting high-volume prescribers

The direct sales force is a key driver for the growth of Fanapt®, particularly following its launch for the acute treatment of Bipolar I disorder. The sales force dedicated to Fanapt® expanded significantly, reaching approximately 300 representatives by the second quarter of 2025, up from approximately 50 representatives in the first quarter of 2024. This investment in personnel directly correlates with prescription growth; face-to-face calls in the third quarter of 2025 were more than 20% higher than in the second quarter of 2025, and more than twice the volume seen in the third quarter of 2024. Fanapt® total prescriptions (TRx) increased by 35% year-over-year in Q3 2025, with new patient starts (NBRx) up 147% year-over-year.

• Sales force size expansion: from 50 reps (Q1 2024) to ~300 reps (Q3 2025).
• Fanapt® new patient starts (NBRx) growth in Q3 2025: 147% year-over-year.
• Face-to-face calls in Q3 2025: more than twice the volume of Q3 2024.

Government channels, including the U.S. Department of Veterans Affairs (VA) contracts

Vanda Pharmaceuticals Inc. engages with government channels, though specific revenue figures from U.S. Department of Veterans Affairs (VA) contracts are not explicitly detailed in the latest reports. The company noted that Medicare policy changes stemming from the Inflation Reduction Act (IRA) will negatively impact gross-to-net revenue figures for both Fanapt® and HETLIOZ® in the Medicare segment throughout 2025. The company is pursuing a collaborative framework with the FDA for the re-review of the HETLIOZ® jet lag supplemental New Drug Application (sNDA) by January 7, 2026.

Digital and traditional media for direct-to-consumer brand visibility

Vanda Pharmaceuticals Inc. maintained strategic investments in commercial infrastructure, including increased brand visibility through targeted sponsorships and a broad direct-to-consumer (DTC) brand awareness campaign that launched in the first quarter of 2025 and continued through the third quarter of 2025. This DTC effort is intended to support long-term market leadership and future commercial launches. The overall U.S. pharmaceutical DTC advertising market is projected to spend approximately $10 billion in 2025. The company has a full-year 2025 total revenue guidance reaffirmed between $210 million and $230 million.

Finance: draft 13-week cash view by Friday.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Customer Segments

Vanda Pharmaceuticals Inc. (VNDA) focuses its customer segments on specific patient populations across psychiatry and neurology, supported by a targeted healthcare professional outreach strategy.

The primary commercialized segments are:

• Patients with Schizophrenia and Bipolar I Disorder (Fanapt, with Bysanti pending FDA action on February 21, 2026)
• Totally blind adults with Non-24-Hour Sleep-Wake Disorder (HETLIOZ)
• Patients with Relapsing Multiple Sclerosis (PONVORY)

The relative importance of these segments, based on net product sales for the first nine months of 2025, is detailed below:

For the third quarter of 2025, total net product sales reached $56.3 million, with Fanapt sales increasing by 31% year-over-year, supported by a 35% growth in total prescriptions (TRx) for that quarter.

Patients with Schizophrenia and Bipolar I Disorder (Fanapt)

This segment is characterized by significant commercial momentum, especially following the launch for Bipolar I disorder in the third quarter of 2024.

• Fanapt total prescriptions (TRx) for the week of April 25, 2025, surpassed 2,000.
• New to brand prescriptions (NBRx) increased nearly threefold in the first quarter of 2025 compared to the first quarter of 2024.
• The potential patient pool for schizophrenia spectrum disorders is estimated to impact about 3.7 million U.S. adults ages 18-65, representing 1.2% of that population.
• Bipolar I Disorder has an estimated annual prevalence of 1.5% among U.S. adults.

Totally blind adults with Non-24-Hour Sleep-Wake Disorder (HETLIOZ)

This segment represents a niche but established market for Vanda Pharmaceuticals Inc. (VNDA), though sales showed a slight decline in the first nine months of 2025 compared to the prior year.

• HETLIOZ net product sales for the first nine months of 2025 were $55.0 million.
• The company is pursuing re-review of its supplemental New Drug Application (sNDA) for the jet lag disorder indication by January 7, 2026.

Patients with Relapsing Multiple Sclerosis (PONVORY)

PONVORY was launched for this segment in the third quarter of 2024.

• The overall U.S. Multiple Sclerosis (MS) population is estimated to be nearly 1 million people.
• Relapsing-remitting MS (RRMS) accounts for 85% to 90% of MS patients in the early stages of the disease.
• PONVORY net product sales for the first nine months of 2025 were $19.8 million.

Healthcare professionals, including psychiatrists and neurologists

These professionals are the key channel customers who prescribe Vanda Pharmaceuticals Inc. (VNDA)'s products. The company has actively invested in its commercial infrastructure to reach them.

• The psychiatry sales force was expanded to approximately 300 representatives.
• The sales force dedicated to PONVORY for multiple sclerosis was expanded to approximately 40 representatives.
• Face-to-face calls increased by more than 20% in the third quarter of 2025 compared to the second quarter of 2025.

Future: Patients with Generalized Pustular Psoriasis (GPP) and Motion Sickness

These represent high-potential future segments contingent on regulatory success.

• Motion sickness patients are targeted with Tradipitant, which has a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
• GPP patients are targeted with Imsidolimab, with the Biologics License Application (BLA) expected to be submitted in the fourth quarter of 2025.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Cost Structure

The Cost Structure for Vanda Pharmaceuticals Inc. is heavily weighted toward commercialization and pipeline advancement as of late 2025.

High Selling, General & Administrative (SG&A) expenses are a primary cost driver, reflecting the ongoing expansion of commercial activities for key products.

Significant Research and Development (R&D) costs support the advancement of the clinical pipeline, including late-stage assets.

Total operating expenses for the second quarter of 2025 reached $91.1 million, an increase of $30.5 million compared to the $60.6 million reported in the second quarter of 2024.

Manufacturing and supply chain costs (Cost of Goods Sold) are implied by the product sales performance and margin structure.

Legal and regulatory costs are embedded within operating expenses, particularly R&D, tied to specific development and dispute activities.

• R&D expenses included costs related to the exclusive global license agreement with Anaptys for Imsidolimab.
• Regulatory milestones included the PDUFA target action date of December 30, 2025, for Tradipitant.
• Regulatory milestones included the PDUFA target action date of February 21, 2026, for Bysanti (milsaperidone).

Costs associated with the expanded sales force and DTC marketing are major components of the elevated SG&A.

• The sales force size was reported at 300 reps.
• A direct to consumer campaign started in the first quarter of 2025 and continued through the second quarter of 2025.

For the first six months of 2025, the jump in SG&A and R&D spend combined was $64.8 million compared to the same period in 2024.

Vanda Pharmaceuticals Inc. (VNDA) - Canvas Business Model: Revenue Streams

You're looking at the core income drivers for Vanda Pharmaceuticals Inc. as of late 2025. The revenue streams are primarily built upon the sales of their commercialized products, with significant focus on the growth trajectory of their newest launch.

The primary revenue source comes from net product sales across the portfolio. For the third quarter of 2025, total net product sales reached $56.3 million. This performance is being used to project the full-year expectation.

Here is the breakdown of the key product sales for the third quarter of 2025:

The performance of Fanapt is a major focus, showing a 31% increase in net product sales compared to the third quarter of 2024. HETLIOZ sales remained relatively stable year-over-year for the quarter, while PONVORY also showed growth compared to the prior year period.

Management has updated the full-year 2025 financial outlook based on these trends and ongoing commercial investments. The current expectation for total revenue from Fanapt, HETLIOZ, and PONVORY for the full year 2025 is set between $210 million and $230 million. This guidance was narrowed from a previous range, reflecting strong Fanapt growth but also HETLIOZ variability and increased investments.

Beyond current product sales, Vanda Pharmaceuticals Inc. has significant potential for future revenue generation tied to its pipeline assets. These streams would materialize upon successful regulatory milestones or through strategic agreements:

• Potential milestone payments from the FDA decision on the tradipitant New Drug Application (NDA) for motion sickness, with a target action date of December 30, 2025.
• Future revenue from the Bysanti NDA for bipolar I disorder and schizophrenia, which has a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026.
• Possible licensing or milestone revenue following the anticipated fourth quarter 2025 submission of the imsidolimab Biologics License Application (BLA) for generalized pustular psoriasis.
• Contingent revenue related to the re-review of the supplemental NDA for HETLIOZ for jet lag disorder by January 7, 2026.

These pipeline events represent contingent, non-product revenue streams that could materially impact future financial performance, though they are not factored into the current product sales guidance.