What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-02-14 compared with 2024-02-08 · 158 added, 145 removed, 224 unchanged (57% of the section changed)

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Vanda Pharmaceuticals Inc.

(we, our 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, 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, 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), Fanapt ® for the treatment of schizophrenia and PONVORY ® , which we acquired the U.S.

and Canadian rights to on December 7, 2023, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults.

HETLIOZ ® is the first product approved by the U.S.

Food and Drug Administration (FDA) for patients with Non-24 and for patients with SMS.

In addition, we have a number of drugs in development, including:

• HETLIOZ ® (tasimelteon) for the treatment of jet lag disorder, insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24;

• Fanapt ® (iloperidone) for the treatment of bipolar I disorder and a long acting injectable (LAI) formulation for the treatment of schizophrenia;

• PONVORY (ponesimod) for the treatment of inflammatory/autoimmune disorders, including but not limited to ulcerative colitis, psoriasis, Crohn's disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata;

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 indications for current products in development, including:

• Fanapt ® (iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia;

• Bysanti TM (milsaperidone), the active metabolite of Fanapt ® (iloperidone), 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;

• VHX-896, the active metabolite of iloperidone;

• 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;

• VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of onychomycosis, hematologic malignancies and with potential use as a treatment for several oncology indications;

• VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist, for the treatment of social/performance anxiety and psychiatric disorders;

• 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 IGHMBP2.

• 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

• The supplemental New Drug Application (sNDA) for HETLIOZ ® in the treatment of insomnia is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of March 4, 2024.

We announced that on February 4, 2024, we received a notification from the FDA stating that the FDA had identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.

No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review.

On February 6, 2024, we filed suit in the U.S.

District Court for the District of Columbia (D.C.

District Court) challenging the FDA’s conduct in reviewing the insomnia sNDA.

We are asking the D.C.

District Court to compel the FDA to adhere to the legally mandated 180-day review period for sNDAs and to declare as unlawful and void the regulations the FDA relies upon to issue complete response letters.

• We are also continuing to pursue FDA approval for HETLIOZ ® in the treatment of jet lag disorder.

We announced in January 2024 that the D.C.

District Court granted our motion for summary judgment on our claim against the FDA for unlawfully delaying a hearing on the approvability of our sNDA for HETLIOZ ® in the treatment of jet lag disorder.

District Court ordered the FDA to either finally resolve our jet lag sNDA or commence a hearing on the sNDA on or before March 5, 2024.

• In January 2024, we filed a petition for a writ of certiorari with the U.S.

Supreme Court to review the decision of the U.S.

Court of Appeals for the Federal Circuit (Federal Circuit) in our HETLIOZ ® Abbreviated New Drug Application (ANDA) litigation against Teva Pharmaceuticals USA, Inc.

(Teva), Apotex Inc.

and Apotex Corp.

(collectively, Apotex).

Teva and Apotex have waived their opportunity to respond to our petition, which is now ripe for decision by the U.S.

Supreme Court.

• The article “Efficacy and Safety of Iloperidone in Bipolar Mania:

A Double-Blind, Placebo-Controlled Study” was published in January 2024 in the Journal of Clinical Psychiatry.

The findings of this pivotal study have been submitted to the FDA as part of our sNDA for Fanapt ® in the treatment of bipolar I disorder in adults.

• The sNDA for Fanapt ® in the treatment of bipolar I disorder in adults is under review by the FDA with a PDUFA target action date of April 2, 2024.

• We completed the acquisition of the U.S.

and Canadian rights to PONVORY ® from Janssen for $100.0 million in December 2023 and the transition is ongoing.

PONVORY ® is a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator, approved by the FDA and Health Canada to treat adults with relapsing forms of multiple sclerosis, and is a potential therapeutic candidate for the treatment of a diverse group of inflammatory/autoimmune disorders ranging from psoriasis to ulcerative colitis.

• We announced in January 2024 that the U.S.

Patent and Trademark Office (USPTO) had issued a notice of allowance for its PONVORY ® patent application, 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinstating treatment after missed doses.

When issued, the patent is anticipated to expire on October 10, 2042.

Upon issuance, we intend to list this patent in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

• The article “The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial” was published in January 2024 in the Clinical Gastroenterology and Hepatology Journal .

The findings of this pivotal study as well as a previously reported positive placebo-controlled study in diabetic and idiopathic gastroparesis have been submitted to the FDA as part of our New Drug Application (NDA) for tradipitant in the treatment of symptoms of gastroparesis in adults.

• In December 2023, we announced that the NDA for tradipitant for the treatment of symptoms of gastroparesis was accepted for filing and is under review by the FDA with a PDUFA target action date of September 18, 2024.

• The second Phase III study of tradipitant in the treatment of motion sickness is over 50% enrolled.

In May 2023, we previously announced positive results from its first Phase III study of tradipitant in the treatment of motion sickness.

We plan to pursue FDA approval upon completion of the clinical development program.

Early-Stage Programs

• In January 2024, we announced that the FDA had approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment.

• In January 2024, we announced that the FDA had also approved the IND to evaluate VTR-297 for the treatment of onychomycosis, a fungal infection of the nail.

• Fanapt ® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder.

We initiated the commercial launch of Fanapt ® in this indication in the third quarter of 2024.

In the fourth quarter of 2024, as compared to the fourth quarter of 2023, new patient starts, as reflected by new to brand prescriptions (NBRx), increased by over 160% and Fanapt ® net product sales increased by 18%.

• We initiated a Phase III program for the long acting injectable (LAI) formulation of Fanapt ® in the fourth quarter of 2024.

• We plan to initiate a study of the Fanapt ® LAI as a once-a-month injectable for the treatment of hypertension to address both treatment resistance and treatment compliance.

• We submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the fourth quarter of 2024 for Fanapt ® for bipolar I disorder and schizophrenia.

• We expect to submit a New Drug Application (NDA) for Bysanti™ to the FDA for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025.

Exclusivity, including pending patent applications, could extend into the 2040s.

• We initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for MDD in the fourth quarter of 2024.

Results are expected in 2026.

• We have initiated clinical programs for HETLIOZ ® in pediatric insomnia and DSPD and these programs are ongoing.

• Our MAA for HETLIOZ ® and HETLIOZ LQ ® for SMS is pending with the EMA.

• We initiated the commercial launch of PONVORY ® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024.

• Investigational New Drug (IND) applications for PONVORY ® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024.

• The NDA for tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of 2024.

• We initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide), in the fourth quarter of 2024.

• We have accepted the opportunity for a hearing with the FDA on the approvability of the NDA for tradipitant for the treatment of symptoms of gastroparesis.

• In February 2025, we announced that we entered into an exclusive, global license agreement with AnaptysBio, Inc.

(Anaptys) for the development and commercialization of imsidolimab (IL-36R antagonist mAb).

We expect to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for GPP for the US and EU.

The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025.

Early-Stage Program Highlights

• VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations.

We expect to initiate a Phase III program in 2025.

• The IND application for VCA-894A in the treatment of CMT2S, an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024.

Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication.

The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025.

• In December 2024, we announced that the FDA has granted Orphan Drug Designation for VGT-1849A, a selective ASO-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans.

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 HETLIOZ ® and Fanapt ® in the U.S.

Our ability to generate meaningful product sales and achieve profitability largely depends on our level of success in commercializing Fanapt ® and 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.

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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.

HETLIOZ ® is available in the U.S.

for distribution through a limited number of specialty pharmacies and is not available in retail pharmacies.

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 specialty pharmacies.

We invoice and record revenue when customers, specialty pharmacies and wholesalers, receive product from the third-party logistics warehouse, which is the point at which control is transferred to the customer.

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 sell HETLIOZ ® in Germany and have a distribution agreement for the commercialization of Fanapt ® in Israel.

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.

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During the year ended December 31, 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, and other reserves related to transactions that resulted in elevated levels of inventory at specialty pharmacy customers during 2023.

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 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 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, and product returns that are resolved during the product expiry period specified in the customer contract.

Due to transactions that resulted in increased inventory stocking at specialty pharmacy customers of HETLIOZ ® in 2023, the time it takes to resolve these uncertainties is expected to be longer than we have historically experienced.

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 expected to be 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 at specialty pharmacy customers of HETLIOZ ® in 2024 and 2023, the time it takes to resolve these uncertainties could be longer than we have historically experienced.

We currently record sales allowances for the following:

• Prompt-pay:

Specialty pharmacies and wholesalers are generally offered discounts for prompt payment.

We expect that the specialty pharmacies and wholesalers will earn prompt payment discounts and, therefore, deduct the full amount of these discounts from total product sales when revenues are recognized.

Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program as well as contracted rebate programs with other payors, including the new Medicare Part D inflationary rebate effective October 1, 2022.

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.

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.

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• Chargebacks:

Chargebacks are discounts that occur when contracted indirect customers purchase directly from specialty pharmacies and wholesalers.

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 specialty pharmacy or wholesaler, in turn, charges back the difference between the price initially paid by the specialty pharmacy or wholesaler and the discounted price paid to the specialty pharmacy or wholesaler by the contracted customer.

• Medicare Part D coverage gap:

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:

The Medicare Part D prescription drug benefit requires 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 coverage gap 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 will be replaced with a new discounting program under the Inflation Reduction Act.

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 current 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.

Manufacturers may be eligible for phase-in of discounts, such as for applicable beneficiaries who are Low Income Subsidy (LIS) eligible under section 1860D-14(a) of the Social Security Act.

We are a specified manufacturer whose applicable drugs for applicable beneficiaries who are LIS eligible will be subject to lower applicable discounts during the phase-in period.

• Service fees:

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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 goods to be resalable.

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 December 31, 2024 or 2023.

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Balances at December 31, 2024 $ 49,939 $ 12,391 $ 62,330

The provision for rebates and chargebacks of $85.9 million and $92.1 million for the years ended December 31, 2023 and 2022, respectively, and their ending balances at December 31, 2023 and 2022, primarily represent Medicaid rebates applicable to sales of Fanapt ® and, to a lesser extent, Medicaid rebates applicable to sales of HETLIOZ ® .

The provision for discounts, returns and other of $28.5 million and $30.6 million for the years ended December 31, 2023 and 2022, 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 both HETLIOZ ® and Fanapt ® .

The provision for rebates and chargebacks of $82.2 million and $85.9 million for the years ended December 31, 2024 and 2023, respectively, and their ending balances at December 31, 2024 and 2023, primarily represent Medicaid rebates.

The provision for discounts, returns and other of $33.4 million and $28.5 million for the years ended December 31, 2024 and 2023, 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.

The ending balances of discounts, returns and other as of December 31, 2024 and 2023 primarily represent estimated product returns of Fanapt ® and wholesaler distribution fees applicable to sales of Fanapt ® .

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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 often are required to estimate a significant portion of our accrued clinical expenses.

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:

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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.

As a result of the unfavorable events and subsequent developments in the fourth quarter of 2022 and second quarter of 2023 related to the HETLIOZ ® patent litigation (see Note 17, Legal Matters , to the consolidated financial statements included in Part II, Item 8 of this Annual Report) we performed impairment reviews for our HETLIOZ ® asset group and determined, based upon our review of undiscounted cash flows, that the carrying value of our HETLIOZ ® asset group, inclusive of the intangible asset, is recoverable.

Accordingly, we did not record an intangible asset impairment charge during the years ended December 31, 2023 and 2022.

As a result of the unfavorable events and subsequent developments in the 2022 and 2023 related to the HETLIOZ ® patent litigation (see Note 18, Legal Matters , to the consolidated financial statements included in Part II, Item 8 of this Annual Report) we performed impairment reviews for our HETLIOZ ® asset group in those years and determined, based upon our review of undiscounted cash flows, that the carrying value of our HETLIOZ ® asset group, inclusive of the intangible asset, is recoverable.

Accordingly, we have not recorded an intangible asset impairment charge in any period.

The litigation and subsequent developments do not affect the sale of HETLIOZ ® in the E.U.

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Income taxes.

We assess the need for a valuation allowance against our deferred tax asset each quarter through the review of all available positive and negative evidence.

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 taxable income.

Projected taxable income includes significant assumptions related to revenue, commercial expenses and research and development activities, which could be affected by the HETLIOZ ® generic competition and our ability to obtain regulatory approval from the FDA for products or new indications in development, among other factors.

The analysis is highly dependent upon historical and projected pretax income.

In 2024, we generated our first 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.

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.

As of December 31, 2024, 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, 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.

Recent Accounting Pronouncements

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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 recently acquired PONVORY ® , 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.

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

acquired rights to PONVORY ® in the U.S.

and Canada in December 2023, 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.

For HETLIOZ ® , the FDA has approved ANDAs for Teva and Apotex, both of which have since launched their generic versions of HETLIOZ ® at risk in the U.S.

In December 2022, the U.S.

District Court for the District of Delaware (Delaware District Court) ruled in favor of Teva and Apotex in our patent litigation relating to their filing of ANDAs for generic versions of HETLIOZ ® in the U.S., and in May 2023, a three-judge panel of the Federal Circuit affirmed this ruling.

In August 2023, the Federal Circuit denied our request for a rehearing.

In January 2024, we filed a petition for a writ of certiorari with the U.S Supreme Court to review the Federal Circuit’s decision.

The Federal Circuit affirmed this ruling, and the U.S.

Supreme Court denied our petition for a writ of certiorari in April 2024.

The FDA has also approved the ANDA for MSN Pharmaceuticals, Inc.

and MSN Laboratories Private Limited (MSN).

The license agreement that we entered into when we settled our patent litigation with MSN (MSN/Impax License Agreement) grants MSN and Impax Laboratories LLC (Impax) a non-exclusive license to manufacture and commercialize MSN’s generic version of HETLIOZ ® in the U.S.

effective as of March 13, 2035, unless prior to that date we obtain pediatric exclusivity for HETLIOZ ® , in which case the license will be effective as of July 27, 2035, or earlier under certain limited circumstances.

In January 2023, MSN and its commercial partner, Amneal Pharmaceuticals, Inc., informed us of their belief that such circumstances had occurred and have since launched their generic version.

In April 2024, we filed litigation against MSN, Impax, and Amneal alleging fraudulent inducement of the license agreement.

See Note 18, Legal Matters , to the consolidated financial statements in Part II, Item 8 of this Annual Report.

The FDA has approved ANDAs for Teva and Apotex, both of which have since launched their generic versions of HETLIOZ ® at risk in the U.S.

The FDA has also

approved the ANDA for MSN Pharmaceuticals, Inc.

and MSN Laboratories Private Limited (MSN), and HETLIOZ ® could face even more competition from other generic companies in the U.S.

HETLIOZ ® could face even more competition from other generic companies in the U.S.

in the near term in light of the patent litigation rulings against us.

The license agreement that we entered into when we settled our litigation with MSN (MSN/Impax License Agreement) grants MSN and Impax Laboratories LLC (Impax) a non-exclusive license to manufacture and commercialize MSN’s generic version of HETLIOZ ® in the U.S.

effective as of March 13, 2035, unless prior to that date we obtain pediatric exclusivity for HETLIOZ ® , in which case the license will be effective as of July 27, 2035.

The MSN/Impax License Agreement also provides that MSN and Impax may launch a generic version of HETLIOZ ® earlier under certain limited circumstances.

In January 2023, MSN and its commercial partner, Amneal Pharmaceuticals, Inc., informed us of their belief that such circumstances had occurred and have since launched their generic version.

We disagree with this position and intend to aggressively defend our legal rights to exclusivity for HETLIOZ ® .

There is no guarantee, however, that we will be successful in our efforts.

Sales of generic versions of HETLIOZ ® have resulted in and could continue to result in a reduction in the demand for HETLIOZ ® and/or the price at which we can sell it and/or create volatility in net product sales in future periods, which could have a material impact on our revenues and results of operations.

In addition, sales of generic versions of HETLIOZ ® have resulted in and could continue to result in a reduction in the demand for HETLIOZ ® and/or the price at which we can sell it and/or create volatility in net product sales in future periods, which could have a material impact on our revenues and results of operations.

On September 18, 2024, the FDA declined to approve our NDA of tradipitant for the treatment of symptoms in gastroparesis, providing us with a Complete Response Letter (CRL).

We will continue to pursue the marketing authorization for tradipitant and will continue to support the expanded access program that is currently serving several dozen patients with gastroparesis.

Year ended December 31, 2024 compared to year ended December 31, 2023

Total revenues decreased by $61.7 million, or 24%, to $192.6 million for the year ended December 31, 2023 compared to $254.4 million for the year ended December 31, 2022.

Total revenues increased by $6.1 million, or 3%, to $198.8 million for the year ended December 31, 2024 compared to $192.6 million for the year ended December 31, 2023.

The impact of the Medicare Part D benefit redesign under the Inflation Reduction Act of 2022, which begins January 1, 2025, is uncertain and will affect all of our products.

Revenues may decline in future periods, potentially significantly, as a result of the Medicare Part D program benefit redesign.

Revenue from net product sales were as follows:

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Change Percent

HETLIOZ ® net product sales

$ 100,167 $ 159,655 $ (59,488) (37) %

Fanapt ® net product sales

$ 94,297 $ 90,873 $ 3,424 4 %

HETLIOZ ® net product sales

76,675 100,167 (23,492) (23) %

PONVORY ® net product sales

1,600 — 1,600 N/A

27,800 1,600 26,200 1638 %

Total net product sales $ 198,772 $ 192,640 $ 6,132 3 %

Fanapt ® net product sales increased by $3.4 million, or 4%, to $94.3 million for the year ended December 31, 2024 compared to $90.9 million for the year ended December 31, 2023.

The increase to net product sales was attributable to an increase in price net of deductions and volume.

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 $23.5 million, or 23%, to $76.7 million for the year ended December 31, 2024 compared to $100.2 million for the year ended December 31, 2023.

The decrease to net product sales was attributable to a decrease in price net of deductions and a decrease in volume.

Our HETLIOZ ® net product sales as reported for the three months ended March 31, 2023 reflected transactions that resulted in higher unit sales as compared to recent prior periods and a significant increase of inventory stocking at specialty pharmacy customers during 2023 and at December 31, 2023.

HETLIOZ ® net product sales during 2023 reflect lower unit sales as a result of generic competition.

HETLIOZ ® net product sales may continue to reflect lower unit sales as a result of continued reduction of the elevated inventory levels at specialty pharmacy customers.

The decrease to net product sales was attributable to a decrease in volume, partially offset by an increase in price, net of deductions, including the impact of changes in constrained revenue.

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.

Going forward, HETLIOZ ® net product sales may reflect lower unit sales as a result of reduction of the elevated inventory levels at specialty pharmacy customers or

may be variable depending upon when specialty pharmacy customers need to purchase again.

Further, HETLIOZ ® net product sales will likely decline in future periods, potentially significantly, related to continued generic competition in the U.S.

Additionally, we constrained HETLIOZ ® net product sales for the year ended December 31, 2023 to an amount not probable of significant revenue reversal.

HETLIOZ ® net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration related to transactions in the early part of 2023 are resolved.

Fanapt ® net product sales decreased by $3.9 million to $90.9 million for the year ended December 31, 2023 compared to $94.7 million for the year ended December 31, 2022.

The decrease to net product sales was attributable to a decrease in volume.

In December 2023, we purchased the right to market and sell PONVORY ® in the U.S.

and Canadian markets from Actelion Pharmaceuticals Ltd.

We constrained HETLIOZ ® net product sales for the years ended December 31, 2024 and 2023 to an amount not probable of significant revenue reversal.

The amount of revenue recognized during the year ended December 31, 2024 related to change in estimates on revenue constrained during 2023 was $1.3 million.

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.

In December 2023, we completed the acquisition of the U.S.

and Canadian rights to PONVORY ® from Actelion Pharmaceuticals Ltd.

(Janssen), a Johnson & Johnson Company.

PONVORY ® net product sales were $1.6 million for the year ended December 31, 2023, which reflects sales during the post-acquisition period.

PONVORY ® net product sales were $27.8 million for the year ended December 31, 2024 and $1.6 million for the year ended December 31, 2023, which reflects sales during the post-acquisition period.

We initiated the commercial launch of PONVORY ® in RMS in the third quarter of 2024.

During the fourth quarter of 2024, we recognized approximately $3.0 million of variable consideration that may be subject to dispute but that we believe is not probable of significant revenue reversal.

Cost of goods sold.

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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 5% of HETLIOZ ® net product sales in Germany and 6% of Fanapt ® net product sales.

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 are expected to end in the second quarter of 2024.

decreased from 10% to 5% in December 2022 and ended in April 2024.

There were 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 $7.2 million and $8.0 million of HETLIOZ ® product and $3.0 million and $3.4 million of Fanapt ® product as of December 31, 2023 and 2022, respectively.

Our inventory balance consisted of $2.0 million of Fanapt ® product, $7.3 million of HETLIOZ ® product and $0.2 million of PONVORY ® product as of December 31, 2024.

Our inventory balance consisted of $3.0 million of Fanapt ® product and $7.2 million of HETLIOZ ® product as of December 31, 2023.

Research and development expenses.

Research and development expenses decreased by $2.4 million, or 3%, to $74.4 million for the year ended December 31, 2024 compared to $76.8 million for the year ended December 31, 2023.

The decrease was primarily due to a decrease in clinical trial expenses associated with our Fanapt ® development program, partially offset by an increase in our tradipitant and VHX-896 development programs.

Expenses for our other development programs, which include expenses incurred on product discovery such as ASO, included a $3.0 million upfront fee expensed in the third quarter of 2022 in consideration for entering into a research and development agreement.

The decrease was primarily due to a decrease associated with our Fanapt ® , tradipitant and other development programs, which include expenses incurred on product discovery such as ASO, partially offset by an increase in expenses associated with our PONVORY ® and CFTR development programs.

The following table summarizes the costs of our product development initiatives for the years ended December 31, 2024 and 2023.

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$ 9,401 $ 11,306

11,306 26,931

Milsaperidone

Tradipitant 23,608 32,781

VTR-297 1,595 1,814

CFTR 6,344 1,490

VTR-297 2,642 1,595

VQW-765 743 988

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(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.

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.

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Selling, general and administrative expenses.

Selling, general and administrative expenses decreased by $23.6 million, or 17%, to $112.9 million for the year ended December 31, 2023 compared to $136.5 million for the year ended December 31, 2022.

The decrease in selling, general and administrative expenses was primarily the result of a decrease in spending on marketing, sales and commercial support activities for our commercial products.

Selling, general and administrative expenses increased by $33.5 million, or 30%, to $146.4 million for the year ended December 31, 2024 compared to $112.9 million for the year ended December 31, 2023.

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, as well as legal and other corporate activities.

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.

Selling, general and administrative expenses may increase in future periods as a result of these ongoing commercial launches, which were initiated in the third quarter of 2024.

Intangible asset amortization .

Intangible asset amortization was $7.3 million for the year ended December 31, 2024 compared to $2.1 million for the year ended December 31, 2023.

Amortization expense increased in 2023 due to amortization on the intangible asset from the recently acquired rights to PONVORY ® in the U.S.

Other income .

Other income was $20.3 million for the year ended December 31, 2023 compared to $5.0 million for the year ended December 31, 2022.

Other income primarily consists of investment income on our marketable securities, which increased in 2023 as a result of higher yields on our marketable securities.

Amortization expense increased in 2024 due to amortization on the intangible asset from the rights to PONVORY ® in the U.S.

and Canada which were acquired in December 2023.

Other income, net .

Other income, net was $17.7 million for the year ended December 31, 2024 compared to $20.3 million for the year ended December 31, 2023.

Other income primarily consists of investment income on our marketable securities.

Provision for income taxes.

A provision for income taxes of $3.8 million and $5.0 million was recorded for the years ended December 31, 2023 and 2022, respectively.

We recorded an income tax benefit of $4.0 million and provision for income taxes of $3.8 million for the years ended December 31, 2024 and 2023, respectively.

Our income tax expense or benefit is determined by applying the statutory tax rates in jurisdictions where we operate to each period’s income before income taxes.

Adjustments are made for permanent differences in taxability or deductibility of pretax items as well as for other items, such as tax credits that are generated on our research and development activities.

Adjustments are made for permanent differences in taxability or deductibility of pretax items as well as for other items, such as tax credits that are generated from our research and development activities.

See Note 15, Income Taxes, to the consolidated financial statements in Part II, Item 8 of this Annual Report for additional information.

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As of December 31, 2024, our total cash and cash equivalents and marketable securities were $374.6 million compared to $388.3 million at December 31, 2023.

Cash decreased in 2023 primarily due to our acquisition of the U.S.

and Canadian rights for PONVORY ® in December 2023.

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.

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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 longer than one year are not material.

Various other long-term agreements entered into for services with other third-party vendors, such as inventory purchase arrangements, 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 operating leases and license agreements.

Our non-cancellable purchase commitments for agreements longer than one year primarily relate to commitments for data services.

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.

See Note 8, Leases , and Note 11, Commitments and Contingencies , respectively, to the consolidated financial statements in Part II, Item 8 of this Annual Report for more information about these commitments.

We do not have any off-balance sheet arrangements.

Based on our current operating plans, which include costs and expenses in connection with our continued clinical development of tradipitant and our other products, pursuit of regulatory approval of tradipitant, U.S.

commercial activities for HETLIOZ ® , Fanapt ® and PONVORY ® , pursuit of regulatory approval of HETLIOZ ® and Fanapt ® in other regions and in other indications, 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.

Based on our current operating plans, which include costs and expenses in connection with our U.S.

commercial activities, continued clinical development of tradipitant and our other products, pursuit of regulatory approval of tradipitant, 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 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.

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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 also may significantly dilute the ownership of 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.

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Operating activities:

Net income $ 2,509 $ 6,275 $ (3,766)

Net income (loss)

$ (18,900) $ 2,509 $ (21,409)

Non-cash charges 9,701 11,039 (1,338)

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Financing activities:

Proceeds from the exercise of stock options — 734 (734)

Principal payments on finance leases

(155) — (155)

Financing activities (155) — (155)

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Operating Activities.

Cash flows provided by operating activities during the year ended December 31, 2023 were $12.8 million, a decrease of $19.2 million compared to $32.0 million during the year ended December 31, 2022.

The decrease reflects a decrease of $3.8 million in net income, a decrease of $8.6 million in non-cash charges primarily due to additional amortization of discounts on our marketable securities, and a decrease of $6.8 million from the net change in operating assets and liabilities.

Cash flows used in operating activities during the year ended December 31, 2024 were $15.8 million, a decrease of $28.6 million compared to cash provided by operating activities of $12.8 million during the year ended December 31, 2023.

The decrease reflects a decrease of $21.4 million in net income, a decrease of $1.3 million in non-cash charges primarily due to an increase in deferred income taxes, partially offset by higher intangible asset amortization due to the PONVORY ® acquisition, and a decrease of $5.8 million from the net change in operating assets and liabilities.

The decrease from net change in operating assets and liabilities includes an increase in accounts receivable, product revenue allowances, and prepaid expenses due to timing.

Investing Activities.

Cash flows used in investing activities during the year ended December 31, 2023 were $12.1 million, a decrease in cash of $62.0 million compared to cash provided by investing activities of $49.9 million during the year ended December 31, 2022.

The change in investing activities reflects the timing of net reinvestment of available cash and cash equivalents in our portfolio of marketable securities and the acquisition of the U.S.

and Canadian rights to PONVORY ® in 2023.

Cash flows used in investing activities during the year ended December 31, 2024 were $17.4 million, a decrease in cash of $5.4 million compared to $12.1 million during the year ended December 31, 2023.

Financing Activities.

Financing activities include proceeds from exercises of stock options.

Financing activities include principal payments for our finance lease liabilities and exercise of stock options.

Cash flows provided by financing activities during the year ended December 31, 2024 were $0.2 million.

There were no exercises of stock options during the year ended December 31, 2023.

There were no principal payments on finance leases during the year ended December 31, 2023 or exercises of stock options during the years ended December 31, 2024 and 2023.

QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK

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We are also exposed to unfavorable fluctuations of the U.S.

dollar, which is our reporting currency, against the currencies of

our operating subsidiaries when their respective financial statements are translated into U.S.

dollar, which is our reporting currency, against the currencies of our operating subsidiaries when their respective financial statements are translated into U.S.

dollars for inclusion in our consolidated financial statements.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis