Vanda Pharmaceuticals Inc.
10/30/2025 | Press release | Distributed by Public on 10/30/2025 05:23
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
| ITEM 2 | Management's Discussion and Analysis of Financial Condition and Results of Operations |
Overview
Vanda Pharmaceuticals Inc. (we, our, us or Vanda) is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients.
We strive to advance novel approaches to bring important new medicines to market through responsible innovation. We are committed to the use of technologies that support sound science, including genetics and genomics, in drug discovery, clinical trials and the commercial positioning of our products.
Our commercial portfolio is currently comprised of three products: Fanapt®for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ®for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome (SMS) and PONVORY®for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. HETLIOZ®is the first product approved by the United States Food and Drug Administration (FDA) for patients with Non-24 and for patients with SMS. In addition, we have a number of drugs and/or additional indications for current products in development, including:
•Fanapt®(iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia;
•BysantiTM(milsaperidone), the active metabolite of Fanapt®, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia and major depressive disorder (MDD);
•HETLIOZ®(tasimelteon) for the treatment of jet lag disorder, insomnia, pediatric insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24;
•PONVORY®(ponesimod) for the treatment of psoriasis and ulcerative colitis;
•Tradipitant (VLY-686), a small molecule neurokinin-1 (NK-1) receptor antagonist, for the treatment of gastroparesis, motion sickness and atopic dermatitis;
•Imsidolimab, an IL-36R antagonist, for the treatment of generalized pustular psoriasis (GPP);
•VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of onychomycosis and hematologic malignancies and with potential use as a treatment for several oncology indications;
•Portfolio of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activators and inhibitors, including VSJ-110 for the treatment of dry eye and ocular inflammation and VPO-227 for the treatment of secretory diarrhea disorders, including cholera;
•VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist, for the treatment of social/performance anxiety and psychiatric disorders; and
•Antisense oligonucleotide (ASO) molecules, including VCA-894A for the treatment of Charcot-Marie-Tooth Disease, Type 2S (CMT2S), caused by cryptic slice site variants within the IGHMBP2 gene and VGT-1849A for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy.
Operational Highlights
Key Operational Highlights - Commercial
•Fanapt®experienced significant growth, with total prescriptions (TRx) increasing by 35% and Fanapt®net product sales increasing by 31% in the third quarter of 2025 as compared to the third quarter of 2024.
•During the first nine months of 2025, our direct-to-consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for our company and our products, Fanapt®and PONVORY®. We maintained strategic investments in our commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches.
Key Operational Highlights - Regulatory & Clinical Development
•A clinical study of tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy®(semaglutide), is now complete. Results are expected in the fourth quarter of 2025.
•On October 1, 2025, we announced that we had agreed on a collaborative framework with the FDA for the resolution of certain disputes regarding HETLIOZ®and tradipitant. Pursuant to the agreement:
◦The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of our New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
◦The FDA will conduct an expedited re-review of our supplemental New Drug Application (sNDA) for HETLIOZ®for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder.
•Bysanti™ NDA for bipolar I disorder and schizophrenia is under review by the FDA with a PDUFA target action date of February 21, 2026.
•Tradipitant NDA for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025.
•A Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for MDD is enrolling patients and results are expected in 2026.
•Imsidolimab Biologics License Application (BLA) in GPP expected to be submitted to the FDA in the fourth quarter of 2025.
•The Phase III study of the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention is enrolling patients.
•A clinical study of the long acting injectable formulation of iloperidone in people with treatment-resistant hypertension is ongoing and we plan to begin enrolling patients soon.
Since we began operations, we have devoted substantially all of our resources to the in-licensing, clinical development and commercialization of our products. Our ability to generate meaningful product sales and achieve profitability largely depends on our level of success in commercializing Fanapt®in the United States (U.S.), HETLIOZ®in the U.S. and Europe and PONVORY®in the U.S. and Canada, on our ability, alone or with others, to complete the development of our products, and to obtain the regulatory approvals for and to manufacture, market and sell our products. The results of our operations will vary significantly from year-to-year and quarter-to-quarter and depend on a number of factors, including risks related to our business, risks related to our industry, and other risks that are detailed in Part I, Item 1A, Risk Factors, of our annual report on Form 10-K (Annual Report) for the year ended December 31, 2024 and Item 1A, Risk Factors, of any Quarterly Report filed subsequent to our Annual Report.
Critical Accounting Policies and Estimates
The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no significant changes in our critical accounting policies including estimates, assumptions and judgments from those described in Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations, included in the Annual Report. A summary of our significant accounting policies appears in the notes to our audited consolidated financial statements included in the Annual Report. However, we believe that the following accounting policies are important to understanding and evaluating our reported financial results as they involve the most significant judgments and estimates used in the preparation of our condensed consolidated financial statements, and we have accordingly included them in this discussion.
Revenue from net product sales. We account for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. We recognize revenue when control of the product is transferred to the customer in an amount that reflects the consideration we expect to be entitled to in exchange for those product sales, which is typically once the product physically arrives at the customer. Sales tax, value-added taxes and usage-based taxes are excluded from revenues.
Fanapt®is available in the U.S. for distribution through a limited number of wholesalers and is available in retail pharmacies. HETLIOZ®is available in the U.S. for distribution through a limited number of specialty pharmacies and is not available in retail pharmacies. PONVORY®is available in the U.S. for distribution primarily through a limited number of specialty distributors and specialty pharmacies. We invoice and record revenue when our customers, wholesalers, specialty pharmacies and specialty distributors, receive product from the third-party logistics warehouse, which is the point at which control is transferred to the customer. Revenues and accounts receivable are concentrated with these customers. Outside the U.S., we have a distribution agreement for the commercialization of Fanapt®in Israel and sell HETLIOZ®in Germany. Receivables are carried at transaction price, net of allowance for credit losses. Allowance for credit losses is measured using historical loss rates based on the aging of receivables and incorporating current conditions and forward-looking estimates.
The transaction price is determined based upon the consideration to which we will be entitled in exchange for transferring product to the customer. Our product sales are recorded net of applicable product revenue allowances for which reserves are established and include discounts, rebates, chargebacks, service fees, co-pay assistance and product returns that are applicable for various government and commercial payors. Where appropriate, our estimates of variable consideration included in the transaction price consider a range of possible outcomes. Allowances for rebates, chargebacks and co-pay assistance are based upon the insurance benefits of the end customer, which are estimated using historical activity and, where available, actual and pending prescriptions for which we have validated the insurance benefits. Variable consideration may be constrained and is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the respective underlying contracts. If actual results in the future vary from our estimates, we adjust our estimate in the period identified, which would affect net product sales in the period such variances become known. During the nine months ended September 30, 2025 and 2024, we constrained the variable consideration for HETLIOZ®net product sales. The constrained revenue relates to the uncertainties of payor utilization, patient demand and chargeback and rebate amounts, including Medicaid, related to the elevated levels of inventory on hand at the specialty pharmacies.
Reserves for variable consideration are classified as product revenue allowances on the Condensed Consolidated Balance Sheets, with the exception of prompt-pay discounts, which are classified as reductions of accounts receivable. The reserve for product returns for which the product may not be returned for a period of greater than one year from the balance sheet date is included as a component of other non-current liabilities in the Condensed Consolidated Balance Sheets. Uncertainties related to variable consideration are generally resolved in the quarter subsequent to period end, with the exception of Medicaid rebates, which are dependent upon the timing of when states submit reimbursement claims, Medicare inflationary rebates, which are billed on an annual basis beginning in 2025, and product returns that are resolved during the product expiry period specified in the customer contract. Due to increased inventory stocking of HETLIOZ®at specialty pharmacy customers in 2025 and 2024, the time it takes to resolve these uncertainties could be longer than we have experienced prior to the entrance of generic competition. We currently record sales allowances for the following:
•Prompt-pay:Wholesalers, specialty pharmacies and specialty distributors, our direct customers, are generally offered discounts for prompt payment. We expect that these direct customers will earn prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized.
•Rebates:Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program as well as contracted rebate programs with other payors, including the Medicare Part D inflationary rebate effective October 1, 2022. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid and Medicare. The allowances for rebates are based on statutory or contracted discount rates and estimated patient utilization.
•Chargebacks:Chargebacks are discounts that occur when contracted indirect customers purchase directly from wholesalers, specialty pharmacies and specialty distributors. Contracted indirect customers, which currently consist primarily of Public Health Service institutions and federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The wholesaler, specialty pharmacy or specialty distributor, in turn, charges back the difference between the price initially paid by the wholesaler, specialty pharmacy or specialty distributor and the discounted price paid to the wholesaler, specialty pharmacy or specialty distributor by the contracted customer.
•Medicare Part D rebates:Prior to January 1, 2025, the Medicare Part D prescription drug benefit required manufacturers to fund approximately 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients for applicable drugs. We account for the Medicare Part D coverage gap using a point of sale model. Estimates for expected Medicare Part D rebates are based, in part, on historical activity and, where available, actual and pending prescriptions when we have validated the insurance benefits. Beginning January 1, 2025, the Medicare Part D coverage gap discount program was replaced with a new discounting program under the Inflation Reduction Act of 2022. The Medicare Part D benefit redesign is expected to result in higher discounts for our
Medicare payor segment relative to the previous Medicare Part D prescription drug coverage gap discount program. Under the redesigned Medicare Part D program, applicable drugs dispensed to applicable beneficiaries will be subject to manufacturer discounts of 10% during the initial coverage phase and 20% during the catastrophic coverage phase. Under the Medicare Part D benefit redesign, we are a specified manufacturer whose applicable drugs for applicable beneficiaries who are Low Income Subsidy eligible under section 1860D-14(a) of the Social Security Act will be subject to lower applicable discounts during the phase-in period.
•Service fees:We receive sales order management, data and distribution services from certain customers, for which we are assessed fees. These fees are based on contracted terms and are known amounts. We accrue service fees at the time of revenue recognition, resulting in a reduction of product sales and the recognition of an accrued liability, unless it is a payment for a distinct good or service from the customer in which case the fair value of those distinct goods or services are recorded as selling, general and administrative expense.
•Co-pay assistance:Patients who have commercial insurance and meet certain eligibility requirements may receive co-pay assistance. Co-pay assistance utilization is based on information provided by our third-party administrator.
•Product returns:We generally offer direct customers a limited right to return as contractually defined with our customers. We consider several factors in the estimation process, including expiration dates of product shipped to customers, inventory levels within the distribution channel, product shelf life, historical return activity, including activity for product sold for which the return period has past, prescription trends and other relevant factors. We do not expect returned products to be resalable. There was no right of return asset as of September 30, 2025 or December 31, 2024.
The following table summarizes sales discounts and allowance activity as of and for the nine months ended September 30, 2025:
| (in thousands) | Rebates & Chargebacks |
Discounts, Returns and Other |
Total | ||||||||||||||
|
Balances at December 31, 2024
|
$ | 49,939 | $ | 12,391 | $ | 62,330 | |||||||||||
| Provision related to current period sales | 75,398 | 32,778 | 108,176 | ||||||||||||||
| Adjustments for prior period sales | (5,252) | (586) | (5,838) | ||||||||||||||
| Credits/payments made | (62,176) | (29,856) | (92,032) | ||||||||||||||
|
Balances at September 30, 2025
|
$ | 57,909 | $ | 14,727 | $ | 72,636 | |||||||||||
The provision of $75.4 million for rebates and chargebacks for the nine months ended September 30, 2025 and its ending balance at September 30, 2025 primarily represents Medicaid rebates applicable to sales of Fanapt®and, to a lesser extent, HETLIOZ®. The provision of $32.8 million for discounts, returns and other for the nine months ended September 30, 2025 primarily represents wholesaler distribution fees applicable to sales of Fanapt®and estimated product returns of Fanapt®, and co-pay assistance costs and prompt-pay discounts applicable to the sales of all of our commercial products.
Stock-based compensation. Compensation costs for all stock-based awards to employees and directors are measured based on the grant date fair value of those awards and recognized over the period during which the employee or director is required to perform service in exchange for the award. We use the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The determination of the fair value of stock options on the date of grant using an option pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include the expected stock price volatility over the expected term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rate and expected dividends. Expected volatility rates are based on the historical volatility of our publicly traded common stock and other factors. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. We have never paid cash dividends to our stockholders and do not plan to pay dividends in the foreseeable future. As stock-based compensation expense recognized in the Condensed Consolidated Statements of Operations is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Research and development expenses. Research and development expenses consist primarily of fees for services provided by third parties in connection with the clinical trials, costs of contract manufacturing services for clinical trial use, milestone payments made under licensing agreements prior to regulatory approval, costs of materials used in clinical trials and research and development, costs for regulatory consultants and filings, depreciation of capital resources used to develop products, related facilities costs, and salaries, other employee-related costs and stock-based compensation for research and development personnel. We expense research and development costs as they are incurred for products in the development stage, including
manufacturing costs and milestone payments made under license agreements prior to FDA approval. Upon and subsequent to FDA approval, manufacturing and milestone payments made under license agreements are capitalized. Milestone payments are accrued when it is deemed probable that the milestone event will be achieved. Costs related to the acquisition of intellectual property are expensed as incurred if the underlying technology is developed in connection with our research and development efforts and has no alternative future use.
Clinical trials are inherently complex, often involve multiple service providers and can include payments made to investigator physicians at study sites. Because billing for services often lags delivery of service by a substantial amount of time, we are often required to estimate a significant portion of our accrued clinical expenses. Our assessments include, but are not limited to: (i) an evaluation by the project manager of the work that has been completed during the period, (ii) measurement of progress prepared internally and/or provided by the third-party service provider, (iii) analyses of data that justify the progress, and (iv) management's judgment. In the event that we do not identify certain costs that have begun to be incurred or we under- or over-estimate the level of services performed or the costs of such services, our reported expenses for such period would be too low or too high.
Intangible assets and impairment of long-lived assets. Our intangible assets consist of capitalized license costs for products approved by the FDA or costs to acquire already commercialized products. We amortize our intangible assets on a straight-line basis over the estimated useful economic life of the related product patents. We assess the impairment of intangible assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors we consider important that could trigger an impairment review include significant underperformance relative to expected historical or projected future operating results, a significant adverse change in legal or regulatory factors that could affect the value or patent life, including our ability to defend and enforce patent claims and other intellectual property rights and significant negative industry or economic trends. When we determine that the carrying value of our intangible assets may not be recoverable based upon the existence of one or more of the indicators of impairment, we measure any impairment based on the amount that carrying value exceeds fair value.
Income taxes.We assess the need for a valuation allowance against our deferred tax assets each quarter through the review of all available positive and negative evidence. Deferred tax assets are reduced by a tax valuation allowance when, in the opinion of management, it is more likely than not that some portion of the deferred tax assets will not be realized. The analysis is highly dependent upon historical and projected pretax income. In 2024, we generated our first full year pretax loss since 2017, largely due to expenditures on the commercial launches of Fanapt®in bipolar I disorder and PONVORY®in RMS. Projected taxable income includes significant assumptions related to revenue, which could be affected by the success of the commercial launches of Fanapt®in bipolar I disorder and PONVORY®in RMS and HETLIOZ®generic competition, commercial and research and development activities, and our ability to obtain regulatory approval from the FDA for products or new indications in development, among other factors. As of September 30, 2025, after considering all available positive and negative evidence, we concluded, consistent with prior periods, that it was more likely than not that substantially all of our deferred tax assets in the U.S. are realizable in future periods. We maintain a valuation allowance against certain state net deferred tax assets. If our results are not in line with our projections or if our projections change, or if there are meaningful changes to our business operations, the conclusion about the appropriateness of the valuation allowance could change in a future period. An increase in the valuation allowance would result in a non-cash income tax expense during the period of change. Any such adjustment could have a material impact on our results of operations.
Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement.
Recent Accounting Pronouncements
See Note 2, Summary of Significant Accounting Policies,to the condensed consolidated financial statements included in Part I of this Quarterly Report for information on recent accounting pronouncements.
Results of Operations
We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including our and our partners' ability to continue to successfully commercialize our products, including activities related to Fanapt®for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, which was approved in April 2024, and PONVORY®for the treatment of RMS, the impact of the Medicare Part D benefit redesign effective January 1, 2025 under the
Inflation Reduction Act of 2022, any possible payments made or received pursuant to license agreements, progress of our research and development efforts, the timing and outcome of clinical trials and related possible regulatory approvals and the status of existing and future potential litigation involving our products and intellectual property. See Note 14, Legal Matters, to the condensed consolidated financial statements included in Part I of this Quarterly Report for information on material legal matters.
Three months ended September 30, 2025 compared to three months ended September 30, 2024
Revenues. Total revenues increased by $8.6 million, or 18%, to $56.3 million for the three months ended September 30, 2025 compared to $47.7 million for the three months ended September 30, 2024. Revenues may decline in future periods, potentially significantly, as a result of the Medicare Part D program benefit redesign. Revenue from net product sales was as follows:
| Three Months Ended | |||||||||||||||||||||||
| (in thousands) |
September 30, 2025 |
September 30, 2024 |
Net Change |
Percent | |||||||||||||||||||
|
Fanapt®net product sales
|
$ | 31,245 | $ | 23,919 | $ | 7,326 | 31 | % | |||||||||||||||
|
HETLIOZ®net product sales
|
17,978 | 17,870 | 108 | 1 | % | ||||||||||||||||||
|
PONVORY®net product sales
|
7,035 | 5,862 | 1,173 | 20 | % | ||||||||||||||||||
| Total net product sales | $ | 56,258 | $ | 47,651 | $ | 8,607 | 18 | % | |||||||||||||||
Fanapt®net product sales increased by $7.3 million, or 31%, to $31.2 million for the three months ended September 30, 2025 compared to $23.9 million for the three months ended September 30, 2024. The increase to net product sales was attributable to an increase in volume, partially offset by a decrease in price net of deductions. We initiated the commercial launch of Fanapt®for bipolar I disorder in adults in the third quarter of 2024.
HETLIOZ®net product sales increased by $0.1 million, or 1%, to $18.0 million for the three months ended September 30, 2025 compared to $17.9 million for the three months ended September 30, 2024. The increase to net product sales was attributable to an increase in volume, partially offset by a decrease in price net of deductions. Our HETLIOZ®net product sales as reported for the three months ended March 31, 2023 reflected higher unit sales as compared to recent prior periods. The higher unit sales during the three months ended March 31, 2023 resulted in a significant increase of inventory stocking at specialty pharmacy customers at March 31, 2023. During the remainder of 2023, although there was continued destocking at specialty pharmacy customers, inventory levels remained elevated relative to inventory levels prior to the entrance of generic competition and remained elevated throughout 2024 and 2025. Going forward, HETLIOZ®net product sales may reflect lower unit sales as a result of the reduction of elevated levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, HETLIOZ®net product sales may decline in future periods, potentially significantly, related to continued generic competition in the U.S. We constrained HETLIOZ®net product sales for the three months ended September 30, 2025 and 2024 to an amount not probable of significant revenue reversal. The amount of revenue recognized during the three months ended September 30, 2025 and 2024 related to changes in estimates on revenue constrained during prior periods was $1.2 million and $0.8 million, respectively. HETLIOZ®net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration related to inventory stocking by specialty pharmacy customers are resolved.
PONVORY®net product sales increased by $1.2 million, or 20%, to $7.0 million for the three months ended September 30, 2025 compared to $5.9 million for the three months ended September 30, 2024. The increase in net product sales was attributable to an increase in volume. We initiated the commercial launch of PONVORY®in RMS in the third quarter of 2024.
Cost of goods sold.Cost of goods sold increased by $0.4 million, or 16%, to $3.0 million for the three months ended September 30, 2025 compared to $2.6 million for the three months ended September 30, 2024. Cost of goods sold includes third-party manufacturing costs of product sold, third-party royalty costs and distribution and other costs. Third-party royalty costs were 6% of Fanapt®net product sales and 5% of HETLIOZ®net product sales in Germany. Third-party royalty costs on HETLIOZ®net product sales in the U.S. decreased from 10% to 5% in December 2022 and ended in April 2024. Third-party royalty costs on HETLIOZ®net product sales in Germany will end in October 2026. There are no third-party royalty costs on net sales of PONVORY®. We evaluate the risk of excess inventory and product expiry by evaluating current and future product demand relative to product shelf life and build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, patient usage, and generic competition. Our inventory balance consisted of $1.7 million of Fanapt®product, $8.0 million of HETLIOZ®product and $0.3 million of PONVORY®product as of September 30, 2025.
Research and development expenses.Research and development expenses increased by $5.8 million, or 34%, to $22.6 million for the three months ended September 30, 2025 compared to $16.8 million for the three months ended September 30, 2024. The increase was primarily due to an increase in expenses across many different development programs, including our Fanapt®development program.
The following table summarizes the costs of our product development initiatives for the three months ended September 30, 2025 and 2024:
| Three Months Ended | |||||||||||
| (in thousands) |
September 30, 2025 |
September 30, 2024 |
|||||||||
| Direct project costs (1) | |||||||||||
|
Fanapt®
|
$ | 3,767 | $ | 1,876 | |||||||
|
BysantiTM
|
2,977 | 2,864 | |||||||||
|
HETLIOZ®
|
2,751 | 2,840 | |||||||||
|
PONVORY®
|
2,514 | 1,027 | |||||||||
| Tradipitant | 3,119 | 4,392 | |||||||||
|
Imsidolimab
|
966 | - | |||||||||
| VTR-297 | 978 | 712 | |||||||||
| CFTR | 2,165 | 806 | |||||||||
| VQW-765 | 1,112 | 194 | |||||||||
| Other | 569 | 318 | |||||||||
| Total direct project costs | 20,918 | 15,029 | |||||||||
| Indirect project costs (1) | |||||||||||
| Stock-based compensation | 458 | 703 | |||||||||
| Other indirect overhead | 1,187 | 1,044 | |||||||||
| Total indirect project costs | 1,645 | 1,747 | |||||||||
| Total research and development expense | $ | 22,563 | $ | 16,776 | |||||||
(1)We record direct costs, including personnel costs and related benefits, on a project-by-project basis. Many of our research and development costs are not attributable to any individual project because we share resources across several development projects. We record indirect costs that support a number of our research and development activities in the aggregate, including stock-based compensation.
We expect to incur significant research and development expenses as we continue to develop our products and continue our efforts to expand our product pipeline.
Selling, general and administrative expenses.Selling, general and administrative expenses increased by $22.7 million, or 60%, to $60.3 million for the three months ended September 30, 2025 compared to $37.6 million for the three months ended September 30, 2024. The increase in selling, general and administrative expenses was primarily the result of an increase in spending on commercial activities related to our commercial launches of Fanapt®in bipolar disorder and PONVORY®in RMS. During 2024, we commenced a host of commercial activities as part of our commercial launches of Fanapt®in bipolar disorder and PONVORY®in RMS, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. A direct-to-consumer campaign that started in the first quarter of 2025 continued in the second and third quarters of 2025, elevating brand awareness of the company and the key products Fanapt®and PONVORY®. Selling, general and administrative expenses may increase in future periods as a result of the ongoing commercial launches.
Intangible asset amortization. Intangible asset amortization was $1.8 million each for the three months ended September 30, 2025 and 2024.
Other income. Other income was $2.9 million for the three months ended September 30, 2025 compared to $4.8 million for the three months ended September 30, 2024. Other income primarily consists of investment income on our marketable securities.
Benefit for income taxes.An income tax benefit of $5.8 million and $0.9 million was recorded for the three months ended September 30, 2025 and 2024, respectively. The income tax benefit for each of the three months ended September 30, 2025 and 2024 was primarily driven by the estimated effective tax rate for the year as well as discrete income tax expense of $0.1 million and $0.2 million, respectively.
Nine months ended September 30, 2025 compared to nine months ended September 30, 2024
Revenues. Total revenues increased by $13.3 million, or 9%, to $158.9 million for the nine months ended September 30, 2025 compared to $145.6 million for the nine months ended September 30, 2024. Revenues were as follows:
| Nine Months Ended | |||||||||||||||||||||||
| (in thousands) |
September 30, 2025 |
September 30, 2024 |
Net Change |
Percent | |||||||||||||||||||
|
Fanapt®net product sales
|
$ | 84,084 | $ | 67,648 | $ | 16,436 | 24 | % | |||||||||||||||
|
HETLIOZ®net product sales
|
55,042 | 56,631 | (1,589) | (3) | % | ||||||||||||||||||
|
PONVORY®net product sales
|
19,763 | 21,308 | (1,545) | (7) | % | ||||||||||||||||||
| Total net product sales | $ | 158,889 | $ | 145,587 | $ | 13,302 | 9 | % | |||||||||||||||
Fanapt®net product sales increased by $16.4 million, or 24%, to $84.1 million for the nine months ended September 30, 2025 compared to $67.6 million for the nine months ended September 30, 2024. The increase to net product sales was attributable to an increase in volume, partially offset by a decrease in price net of deductions. We initiated the commercial launch of Fanapt®for bipolar I disorder in adults in the third quarter of 2024.
HETLIOZ®net product sales decreased by $1.6 million, or 3%, to $55.0 million for the nine months ended September 30, 2025 compared to $56.6 million for the nine months ended September 30, 2024. The decrease to net product sales was attributable to a decrease in volume. Our HETLIOZ®net product sales as reported for the three months ended March 31, 2023 reflected higher unit sales as compared to recent prior periods. The higher unit sales during the three months ended March 31, 2023 resulted in a significant increase of inventory stocking at specialty pharmacy customers at March 31, 2023. During the remainder of 2023, although there was continued destocking at specialty pharmacy customers, inventory levels remained elevated relative to inventory levels prior to the entrance of generic competition and remained elevated throughout 2024 and 2025. Going forward, HETLIOZ®net product sales may reflect lower unit sales as a result of the reduction of elevated levels at specialty pharmacy customers or may be variable depending upon when specialty pharmacy customers need to purchase again. Further, HETLIOZ®net product sales may decline in future periods, potentially significantly, related to continued generic competition in the U.S. The Company constrained HETLIOZ®net product sales for the nine months ended September 30, 2025 and 2024 to an amount not probable of significant revenue reversal. The amount of revenue recognized during the nine months ended September 30, 2025 and 2024 related to changes in estimates on revenue constrained during prior periods was $0.8 million and $1.4 million, respectively. HETLIOZ®net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration related to inventory stocking by specialty pharmacy customers are resolved.
PONVORY®net product sales decreased by $1.5 million, or 7%, to $19.8 million for the nine months ended September 30, 2025 compared to $21.3 million for the nine months ended September 30, 2024. The decrease in net product sales was attributable to a decrease in price net of deductions. We initiated the commercial launch of PONVORY®in RMS in the third quarter of 2024. An amount of variable consideration related to PONVORY®net product sales is subject to dispute, of which approximately $3.0 million was recognized for the three months ended December 31, 2024.
Cost of goods sold.Cost of goods sold increased by $0.5 million, or 6%, to $9.2 million for the nine months ended September 30, 2025 compared to $8.7 million for the nine months ended September 30, 2024. Cost of goods sold includes third-party manufacturing costs of product sold, third-party royalty costs and distribution and other costs. Third-party royalty costs were 6% of Fanapt®net product sales and 5% of HETLIOZ®net product sales in Germany. Third-party royalty costs on HETLIOZ®net product sales in the U.S. decreased from 10% to 5% in December 2022 and ended in April 2024. Third-party royalty costs on HETLIOZ®net product sales in Germany will end in October 2026. There are no third-party royalty costs on net sales of PONVORY®. We evaluate the risk of excess inventory and product expiry by evaluating current and future product demand relative to product shelf life and build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, patient usage, and generic competition. Our inventory balance consisted of $1.7 million of Fanapt®product, $8.0 million of HETLIOZ®product and $0.3 million of PONVORY®product as of September 30, 2025.
Research and development expenses.Research and development expenses increased by $25.7 million, or 47%, to $80.3 million for the nine months ended September 30, 2025 compared to $54.6 million for the nine months ended September 30, 2024. The increase in research and development expenses was primarily due to an upfront payment to AnaptysBio, Inc. for the exclusive, global license to develop, manufacture, and commercialize imsidolimab and drug supply as well as an increase in expenses for our Fanapt®and BysantiTMdevelopment programs, partially offset by a decrease in expenses for our tradipitant development program.
The following table summarizes the costs of our product development initiatives for the nine months ended September 30, 2025 and 2024:
| Nine Months Ended | |||||||||||
| (in thousands) |
September 30, 2025 |
September 30, 2024 |
|||||||||
| Direct project costs (1) | |||||||||||
|
Fanapt®
|
$ | 11,002 | $ | 5,848 | |||||||
|
BysantiTM
|
9,376 | 4,390 | |||||||||
|
HETLIOZ®
|
9,665 | 7,271 | |||||||||
|
PONVORY®
|
6,404 | 4,052 | |||||||||
| Tradipitant | 11,134 | 18,609 | |||||||||
|
Imsidolimab
|
15,336 | - | |||||||||
| VTR-297 | 2,561 | 1,985 | |||||||||
| CFTR | 5,552 | 4,927 | |||||||||
| VQW-765 | 1,762 | 564 | |||||||||
| Other | 1,419 | 1,154 | |||||||||
| Total direct project costs | 74,211 | 48,800 | |||||||||
| Indirect project costs (1) | |||||||||||
| Stock-based compensation | 1,819 | 2,241 | |||||||||
| Other indirect overhead | 4,235 | 3,550 | |||||||||
| Total indirect project costs | 6,054 | 5,791 | |||||||||
| Total research and development expense | $ | 80,265 | $ | 54,591 | |||||||
(1)We record direct costs, including personnel costs and related benefits, on a project-by-project basis. Many of our research and development costs are not attributable to any individual project because we share resources across several development projects. We record indirect costs that support a number of our research and development activities in the aggregate, including stock-based compensation.
We expect to incur significant research and development expenses as we continue to develop our products and continue our efforts to expand our product pipeline.
Selling, general and administrative expenses.Selling, general and administrative expenses increased by $67.8 million, or 63%, to $175.0 million for the nine months ended September 30, 2025 compared to $107.1 million for the nine months ended September 30, 2024. The increase in selling, general and administrative expenses was primarily the result of an increase in spending on commercial activities related to our commercial launches of Fanapt®in bipolar disorder and PONVORY®in relapsing forms of MS. During 2024, we commenced a host of commercial activities as part of our commercial launches of Fanapt®in bipolar disorder and PONVORY®in RMS, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. A direct-to-consumer campaign that started in the first quarter of 2025 continued in the second and third quarters of 2025, elevating brand awareness of the company and the key products Fanapt®and PONVORY®. Selling, general and administrative expenses may increase in future periods as a result of the ongoing commercial launches.
Intangible asset amortization. Intangible asset amortization was $5.3 million and $5.5 million for the nine months ended September 30, 2025 and 2024, respectively.
Other income. Other income was $10.2 million for the nine months ended September 30, 2025 compared to $14.0 million for the nine months ended September 30, 2024. Other income primarily consists of investment income on our marketable securities.
Benefit for income taxes.We recorded an income tax benefit of $21.4 million and $2.4 million for the nine months ended September 30, 2025 and 2024, respectively. The income tax benefit for the nine months ended September 30, 2025 and 2024 was primarily driven by the estimated effective tax rate for the year, as well as discrete income tax expense of $0.9 million and $1.0 million, respectively.
Liquidity and Capital Resources
As of September 30, 2025, our total cash and cash equivalents and marketable securities were $293.8 million compared to $374.6 million at December 31, 2024. Our cash and cash equivalents are deposits in operating accounts and highly liquid investments with an original maturity of 90 days or less at date of purchase and consist of investments in money market funds with commercial banks and financial institutions and commercial paper of high-quality corporate issuers. Our marketable securities consist of investments in government sponsored and corporate enterprises and commercial paper.
Our liquidity resources as of September 30, 2025 and December 31, 2024 are summarized as follows:
| (in thousands) |
September 30, 2025 |
December 31, 2024 | |||||||||
| Cash and cash equivalents | $ | 70,022 | $ | 102,316 | |||||||
| Marketable securities: | |||||||||||
| U.S. Treasury and government agencies | 179,586 | 227,830 | |||||||||
| Corporate debt | 44,144 | 44,497 | |||||||||
| Total marketable securities | 223,730 | 272,327 | |||||||||
| Total cash, cash equivalents and marketable securities | $ | 293,752 | $ | 374,643 | |||||||
As of September 30, 2025, we maintained all of our cash, cash equivalents and marketable securities in two financial institutions. Deposits held with these institutions may exceed the amount of insurance provided on such deposits, but we do not anticipate any losses with respect to such deposits.
In the normal course of our business, we regularly enter into agreements with third-party vendors under fee service arrangements which generally may be terminated on 90 days' notice without incurring additional charges, other than charges for work completed or materials procured but not paid for through the effective date of termination and other costs incurred by our contractors in closing out work in progress as of the effective date of termination. Our non-cancellable purchase commitments for agreements with a remaining non-cancellable term longer than one year from September 30, 2025 primarily relate to commitments for data services and marketing activities. Various other long-term agreements entered into for services with other third-party vendors, such as inventory purchase commitments, are cancellable in nature or contain variable commitment terms within the agreement that are within our control. We also have long-term contractual obligations related to our leases and license agreements.
Other than as disclosed in Note 8, Commitments and Contingencies, to the condensed consolidated financial statements included in Part I of this Quarterly Report, there have been no material changes to our long-term contractual obligations as disclosed in Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report. For further information regarding our long-term non-cancellable purchase commitments, leases and license agreements, see Note 8, Commitments and Contingencies.
We do not have any off-balance sheet arrangements.
Based on our current operating plans, which include costs and expenses in connection with our U.S. commercial activities, continued clinical development of tradipitant, BysantiTMand our other products, pursuit of regulatory approval of tradipitant, BysantiTMand imsidolimab, pursuit of further regulatory approvals for our currently approved products and payments due upon achievement of milestones under our license agreements, we believe that our cash, cash equivalents and marketable securities and cash received from product sales will be sufficient for at least the next 12 months. Our future cash requirements and the adequacy of our available funds will depend on many factors, primarily including a regulatory approval of tradipitant, BysantiTMand imsidolimab, our ability to generate revenue, the scope and costs of our commercial, manufacturing and process development activities, the magnitude of our discovery, preclinical and clinical development programs, and potential costs to acquire or license the rights to additional products.
We may need or desire to obtain additional capital to finance our operations through debt, equity or alternative financing arrangements. We may also seek capital through collaborations or partnerships with other companies. The issuance of debt could require us to grant liens on certain of our assets that may limit our flexibility and debt securities may be convertible into common stock. If we raise additional capital by issuing equity securities, the terms and prices for these financings may be much more favorable to the new investors than the terms obtained by our existing stockholders. These financings may also significantly dilute the ownership of our existing stockholders. If we are unable to obtain additional financing, we may be required to reduce the scope of our future activities, which could harm our business, financial condition and operating results. There can be no assurance that any additional financing required in the future will be available on acceptable terms, if at all.
Cash Flow
The following table summarizes our net cash flows from operating, investing and financing activities for the nine months ended September 30, 2025 and 2024:
| Nine Months Ended | |||||||||||||||||
| (in thousands) |
September 30, 2025 |
September 30, 2024 |
Net Change |
||||||||||||||
| Net cash provided by (used in): | |||||||||||||||||
| Operating activities: | |||||||||||||||||
|
Net loss
|
$ | (79,287) | $ | (13,988) | $ | (65,299) | |||||||||||
| Non-cash charges | (6,020) | 7,324 | (13,344) | ||||||||||||||
| Net change in operating assets and liabilities | 5,282 | (7,276) | 12,558 | ||||||||||||||
| Operating activities | (80,025) | (13,940) | (66,085) | ||||||||||||||
| Investing activities: | |||||||||||||||||
|
Asset acquisition
|
- | (4,229) | 4,229 | ||||||||||||||
| Purchases of property and equipment | (896) | (276) | (620) | ||||||||||||||
| Net purchases, sales and maturities of marketable securities | 50,890 | (16,918) | 67,808 | ||||||||||||||
| Investing activities | 49,994 | (21,423) | 71,417 | ||||||||||||||
| Financing activities: | |||||||||||||||||
|
Principal payments on finance leases
|
(1,351) | - | (1,351) | ||||||||||||||
| Tax obligations paid in connection with settlement of restricted stock units | (915) | - | (915) | ||||||||||||||
| Financing activities | (2,266) | - | (2,266) | ||||||||||||||
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash
|
3 | 39 | (36) | ||||||||||||||
| Net change in cash, cash equivalents and restricted cash | $ | (32,294) | $ | (35,324) | $ | 3,030 | |||||||||||
Operating Activities:Cash flows used in operating activities during the nine months ended September 30, 2025 were $80.0 million, a decrease of $66.1 million compared to $13.9 million during the nine months ended September 30, 2024. The decrease primarily reflects a decrease of $65.3 million in net income, non-cash charges, including the change in deferred income taxes, as well as the net change in operating assets and liabilities. Our net loss for the nine months ended September 30, 2025 includes expenses associated with the $15.0 million payment related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab. The decrease in net change in operating assets and liabilities is primarily due to timing of payments for product revenue allowances and receipt of cash for accounts receivable.
Investing Activities:Cash flows provided by investing activities during the nine months ended September 30, 2025 were $50.0 million, an increase of $71.4 million compared to $21.4 million cash used in investing activities during the nine months ended September 30, 2024. The change in investing activities primarily reflects the timing of reinvestment of available cash and cash equivalents and maturities of the investments in our portfolio of marketable securities. Additionally, the $4.2 million asset acquisition cash flow during the nine months ended September 30, 2024 relates to the payment of the remaining consideration for the PONVORY®acquisition that was accrued as of December 31, 2023.
Financing Activities: Financing activities include principal payments for our finance lease liabilities and tax obligations paid in connection with settlement of restricted stock units. Cash flows used in financing activities during the nine months ended September 30, 2025 were $2.3 million. There were no financing cash flows for the nine months ended September 30, 2024.
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