Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $102.6 million, a 5% increase compared to $97.9 million for the same period in 2024, primarily driven by growth in Fanapt revenue due to the bipolar commercial launch [15][16] - Net loss for the first six months of 2025 was $56.7 million, compared to a net loss of $8.7 million for the same period in 2024, with operating expenses increasing to $182.2 million from $117.3 million [20][27] - Cash and cash equivalents as of June 30, 2025, were $325.6 million, a decrease of $49.1 million compared to December 31, 2024 [21] Business Line Data and Key Metrics Changes - Fanapt net product sales for the first six months of 2025 were $52.8 million, a 21% increase compared to $43.7 million in the same period in 2024, attributed to increased volume [16][22] - HETLIOZ net product sales were $37.1 million for the first six months of 2025, a 4% decrease compared to $38.8 million in the same period in 2024, due to a decrease in volume [16][19] - POMVORY net product sales were $12.7 million for the first six months of 2025, an 18% decrease compared to $15.4 million in the same period in 2024, attributed to a decrease in volume and price [19] Market Data and Key Metrics Changes - Fanapt revenue increased by 27% compared to the same period in the prior year, driven by the launch of the bipolar I indication, with total prescriptions increasing by approximately 24% compared to 2024 [7][22] - HETLIOZ continues to retain the majority of market share despite generic competition for over two and a half years [17] - POMVORY new patient prescriptions grew to a record high since the initiation of Vanda's commercial launch [30] Company Strategy and Development Direction - The company is focused on expanding its sales force and increasing prescriber awareness for Fanapt and POMVORY, with plans to grow the sales force to approximately 50 representatives for POMVORY [29][30] - Vanda is preparing for the potential launch of Bisanti, with commercial product preparedness expected by the end of Q2 2026 [38] - The company aims to achieve total revenue from Fanapt, HETLIOZ, and POMVORY of between $210 million and $250 million by year-end 2025, indicating significant growth potential [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing commercial efforts for Fanapt and POMVORY, noting significant growth indicators and a strong market response [28][29] - The company anticipates variability in HETLIOZ revenue due to continued generic competition and inventory stocking changes at specialty pharmacy customers [18][19] - Management highlighted the importance of ongoing investments in R&D and commercial strategies to facilitate future revenue growth [34] Other Important Information - The NDA for Bisanti for the acute treatment of bipolar I disorder was accepted for filing by the FDA, with a PDUFA target action date of February 21, 2026 [9][10] - The company is also pursuing regulatory updates for Tradipitant, with a target filing date for motion sickness set for December 30, 2025 [11][52] Q&A Session Summary Question: Outlook for Bisanti commercialization - Management expects to be ready for launch by the end of Q2 2026 if approved, with minimal additional commercial operation spend needed [38] Question: Nature of dispute related to POMVORY - The dispute relates to a gross to net item, with approximately $3 million recognized for the three months ended December 31, 2024, under dispute [42] Question: Progress on Tradipitant - Tradipitant for motion sickness is under review, with potential market entry as early as January 1, 2026, if approved [52] Question: Interactions with the FDA regarding Bisanti - Regulatory review is ongoing with no major issues reported, and the company is encouraged by the progress [58] Question: Margins and Medicaid impact for Bisanti - Medicaid typically accounts for 30% to 40% of unit volume, with significant rebates impacting net revenue calculations [60][62]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 (Exact name of registrant as specified in its charter) Delaware 03-0491827 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2200 Pennsylvania Avenue NW, Suite 300E Washington, DC 20037 (202) 734-3400 (Registrant's t ...

Financial Performance - Fanapt Q2 2025 net product sales increased by 27% to $29.3 million compared to Q2 2024[6] - Total net product sales from Fanapt, HETLIOZ, and PONVORY were $52.6 million in Q2 2025, a 4% increase compared to $50.5 million in Q2 2024[7] - Net loss was $27.2 million in Q2 2025, compared to a net loss of $4.5 million in Q2 2024[9] - Vanda expects total revenues for 2025 to be between $210 million and $250 million[11] - HETLIOZ net product sales were $16.2 million in Q2 2025, a 13% decrease compared to $18.7 million in Q2 2024[7] - PONVORY net product sales were $7.1 million in Q2 2025, an 18% decrease compared to $8.6 million in Q2 2024[7] - Fanapt experienced a 24% increase in total prescriptions (TRx) in Q2 2025 compared to Q2 2024[13] Assets and Liabilities - Cash, cash equivalents, and marketable securities were $325.6 million as of June 30, 2025, a decrease of $15.4 million compared to March 31, 2025[7] - Total assets decreased from $656,204 million in December 2024 to $624,746 million in June 2025, a decline of approximately 4.5%[22] - Total current assets fell from $438,890 million to $394,921 million, representing a decrease of about 10%[22] - Total liabilities increased from $117,658 million to $138,417 million, an increase of approximately 17.6%[22] - Total stockholders' equity decreased from $538,546 million to $486,329 million, a decline of about 9.7%[22] - Accounts payable and accrued liabilities rose significantly from $39,086 million to $57,119 million, an increase of approximately 46.2%[22] - Cash and cash equivalents decreased from $102,316 million to $80,983 million, a decline of approximately 20.7%[22] - Inventory increased from $1,726 million to $2,169 million, representing an increase of about 25.7%[22] - Deferred tax assets rose from $81,440 million to $97,143 million, an increase of approximately 19.2%[22] - Accumulated deficit increased from $(174,292) million to $(230,993) million, reflecting a worsening of approximately 32.5%[22] Regulatory Updates - Bysanti NDA for bipolar I disorder and schizophrenia has a PDUFA target action date of February 21, 2026[6] - Tradipitant NDA for motion sickness has a PDUFA target action date of December 30, 2025[6]

Core Insights - Vanda Pharmaceuticals reported a significant increase in Fanapt revenue, driven by expanded sales efforts and a direct-to-consumer brand awareness campaign, with expectations for continued growth in upcoming quarters [2][6] - The company anticipates important regulatory and clinical milestones that could enhance its commercial portfolio and advance its clinical pipeline [2] Financial Highlights - In Q2 2025, net product sales from Fanapt® reached $29.3 million, a 27% increase from $23.2 million in Q2 2024 [6][7] - Total net product sales from Fanapt®, HETLIOZ®, and PONVORY® were $52.6 million in Q2 2025, a 4% increase compared to $50.5 million in Q2 2024 [7] - The net loss for Q2 2025 was $27.2 million, compared to a net loss of $4.5 million in Q2 2024 [9] - Cash and cash equivalents stood at $325.6 million as of June 30, 2025, reflecting a decrease of $15.4 million from March 31, 2025 [7] Operational Highlights - Bysanti™ NDA for bipolar I disorder and schizophrenia is under FDA review with a PDUFA target action date of February 21, 2026 [6][8] - Tradipitant NDA for motion sickness is also under review, with a PDUFA target action date of December 30, 2025 [6][14] - Fanapt® experienced a 24% increase in total prescriptions (TRx) in Q2 2025 compared to Q2 2024 [7] Financial Guidance - Vanda expects total revenues for the full year 2025 to be between $210 million and $250 million, with year-end cash projected to be between $280 million and $320 million [11]

Company Announcement - Vanda Pharmaceuticals Inc. will release its second quarter 2025 results on July 31, 2025, before the market opens [1] - A conference call will be held at 8:00 AM ET on the same day to discuss the financial results and corporate activities [2] - The conference call will be available for live broadcast and archived on Vanda's website [3] Replay Information - A replay of the conference call will be accessible starting at 11:00 AM ET on July 31, 2025, until August 7, 2025, at 11:59 PM ET [4] - Specific call-in numbers for domestic and international callers are provided for the replay [4] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [5]

Group 1 - Vanda Pharmaceuticals Inc. will participate in the ASCP Annual Meeting from May 27 to May 30, 2025, presenting pharmacokinetic results of Milsaperidone and Iloperidone [1] - The presentation will include a poster titled "Pharmacokinetic Results of Single-Dose and Multiple-Dose Bioequivalence Studies of Milsaperidone and Iloperidone Immediate-Release Oral Tablets" [1] Group 2 - Bysanti™ is a new atypical antipsychotic drug that, if approved, could be available for sale in the US in 2026 [2] - Bysanti™ is expected to interact with various neurotransmitter receptors, including alpha-adrenergic, serotonin, and dopamine receptors [2] - Patent exclusivity for Bysanti™ could extend into the 2040s [2] Group 3 - Vanda Pharmaceuticals Inc. is focused on developing and commercializing innovative therapies to meet high unmet medical needs [3]

Company Overview - Vanda Pharmaceuticals Inc. is a leading global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs and improve patient lives [2]. Upcoming Events - The company will participate in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025 in New York City on May 21, 2025 [1].

Financial Performance - Total revenues for the three months ended March 31, 2025, were $50,041,000, an increase from $47,462,000 in the same period of 2024, representing a growth of 3.3%[15] - Net loss for the first quarter of 2025 was $29,494,000, compared to a net loss of $4,146,000 in the first quarter of 2024, indicating a significant increase in losses[15] - Comprehensive loss for the three months ended March 31, 2025, was $29,185,000, compared to a comprehensive loss of $4,499,000 in the same period of 2024[17] - For the three months ended March 31, 2025, Vanda Pharmaceuticals reported total net product sales of $50,041,000, an increase from $47,462,000 in the same period of 2024, representing a growth of 3.3%[32] - Total operating expenses for the same period were $91,069,000, a significant increase of 60.7% from $56,697,000 in the prior year[15] - The net loss for the three months ended March 31, 2025, was $29,494,000, compared to a net loss of $4,146,000 for the same period in 2024, indicating a substantial increase in losses[15] Expenses - Research and development expenses rose to $35,712,000 in Q1 2025, up from $21,154,000 in Q1 2024, reflecting a 68.7% increase[15] - Selling, general and administrative expenses increased to $50,084,000 in Q1 2025, compared to $30,085,000 in Q1 2024, marking a 66.6% rise[15] - Stock-based compensation expense for the three months ended March 31, 2025, totaled $2.97 million, down from $3.58 million in the same period in 2024, representing a decrease of 17.0%[67] Cash and Assets - Cash and cash equivalents as of March 31, 2025, were $111,796,000, up from $102,316,000 at the end of 2024, showing an increase of 9.5%[14] - Total assets decreased to $631,936,000 as of March 31, 2025, from $656,204,000 at the end of 2024, a decline of 3.7%[14] - Total cash provided by (used in) operating activities for the three months ended March 31, 2025, was $(33,147,000), compared to $7,569,000 in 2024, indicating a significant cash outflow[21] - The company’s total cash, cash equivalents, and restricted cash at the end of March 31, 2025, were $112,265,000, down from $125,627,000 at the end of March 31, 2024, a decrease of 10.7%[31] Product Sales - HETLIOZ net product sales for the three months ended March 31, 2025, were $20,872,000, slightly up from $20,053,000 in 2024, showing an increase of 4.1%[32] - Fanapt net product sales increased to $23,545,000 for the three months ended March 31, 2025, compared to $20,579,000 in 2024, marking a growth of 9.5%[32] - PONVORY net product sales decreased to $5,624,000 in the first quarter of 2025 from $6,830,000 in the same quarter of 2024, a decline of 17.6%[32] Legal Proceedings - The Company filed a lawsuit against the FDA in September 2023, challenging the approval of MSN's ANDA for its generic version of HETLIOZ capsules, claiming the approval data is faulty[78] - In December 2024, the Company filed a lawsuit against Teva and Apotex, asserting that their generic versions of HETLIOZ infringe U.S. Patent No. 11,918,556[79] - The Company has ongoing litigation regarding multiple patents related to HETLIOZ LQ, with a trial scheduled to begin on June 15, 2026[79] - The Company filed a lawsuit in May 2022 against the FDA for denying Fast Track designation for tradipitant, which was ruled against in August 2023[81] - The Company has a pending lawsuit against the FDA regarding its sNDA for HETLIOZ in the treatment of insomnia, with a hearing scheduled for May 2025[83] Shareholder Information - The weighted average shares outstanding for basic calculations increased to 58,527,775 in Q1 2025 from 57,760,940 in Q1 2024[15] - As of March 31, 2025, there are 7,846,424 shares subject to outstanding options and RSUs under the 2006 and 2016 Equity Incentive Plans[57] - The Company has $2.2 million of unrecognized compensation costs related to unvested service option awards expected to be recognized over a weighted average period of 0.8 years[60] Tax and Regulatory Matters - The company recorded an income tax benefit of $7.9 million for the three months ended March 31, 2025, compared to $0.5 million in 2024, indicating a significant increase in tax benefits[68] - The company maintained a valuation allowance against certain state net deferred tax assets, indicating ongoing assessments of deferred tax asset realizability[69] Market Strategy and Innovation - The Company has a diverse pipeline of products in development, including formulations for schizophrenia and various sleep disorders, indicating ongoing innovation and market expansion efforts[27] - The Company is actively pursuing market expansion and commercialization strategies for its products, including HETLIOZ and PONVORY, amidst competitive pressures[9] - The company is actively developing additional indications for its current products and has a pipeline of new drugs targeting various medical conditions[27]

Group 1 - Vanda Pharmaceuticals reported a quarterly loss of $0.50 per share, which was better than the Zacks Consensus Estimate of a loss of $0.55, and compared to a loss of $0.07 per share a year ago, indicating an earnings surprise of 9.09% [1] - The company posted revenues of $50.04 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 6.47%, and this represents an increase from year-ago revenues of $47.46 million [2] - Vanda has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] Group 2 - The stock has underperformed the market, losing about 8.8% since the beginning of the year, compared to the S&P 500's decline of 4.7% [3] - The current consensus EPS estimate for the coming quarter is -$0.18 on revenues of $55.25 million, and for the current fiscal year, it is -$1.12 on revenues of $225 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the top 35% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $50 million, a 5% increase from $47.5 million in Q1 2024, primarily due to growth in Fanapt revenue from the bipolar commercial launch [18][19] - Net loss for Q1 2025 was $29.5 million, compared to a net loss of $4.1 million in Q1 2024, reflecting increased expenses related to commercial activities and a $15 million payment for a licensing agreement [23][24] - Operating expenses in Q1 2025 were $91.1 million, up from $56.7 million in Q1 2024, driven by higher R&D and SG&A expenses [25] Business Line Data and Key Metrics Changes - Fanapt net product sales were $23.5 million in Q1 2025, a 14% increase from $20.6 million in Q1 2024, with total prescriptions increasing by approximately 14% [19][9] - HETLIOZ net product sales were $20.9 million in Q1 2025, a 4% increase from $20.1 million in Q1 2024, despite ongoing generic competition [20] - PONVORY net product sales were $5.6 million in Q1 2025, an 18% decrease from $6.8 million in Q1 2024, attributed to a decrease in volume [21] Market Data and Key Metrics Changes - Fanapt reached a milestone of 2,000 weekly prescriptions by the week of April 25, 2025, making it one of the fastest-growing atypical antipsychotics [9][26] - HETLIOZ continues to retain the largest market share despite generic competition for over two years [20] - The company expanded its psychiatry sales force to approximately 300 representatives, enhancing its market reach [27] Company Strategy and Development Direction - Vanda is in a new growth phase with multiple commercialized products and a robust pipeline, including recent NDA filings for Tradipitant and Vicente [7][8] - The company is focusing on expanding its commercial infrastructure and anticipates significant revenue growth from its product launches in 2025 and beyond [26][30] - Vanda expects to have six products commercially available by 2026, indicating a strong pipeline and market potential [29][30] Management's Comments on Operating Environment and Future Outlook - Management highlighted the strong market response to the commercial launch of Fanapt, with significant increases in new patient starts and total prescriptions [26][27] - The company anticipates variability in HETLIOZ revenue due to ongoing generic competition and inventory stocking changes [20][30] - Management reiterated its revenue guidance for 2025, expecting total revenues from key products to be between $210 million and $250 million, reflecting a growth of 626% compared to 2024 [30][31] Other Important Information - The company has initiated direct-to-consumer campaigns for both Fanapt and PONVORY, receiving positive feedback and increasing brand awareness [46] - Vanda is actively working through D120 questions from the EMA regarding its marketing applications for Fanapt and HETLIOZ [51] Q&A Session Summary Question: What kind of placebo adjusted change on MADRS or HAM D would be desired for a competitive profile for milseperidone? - Management indicated that they have not prespecified the margin, noting variability in major depression studies [35] Question: Can you provide details on the Phase III social anxiety study design? - Management stated that the study is set to begin in Q3 and referred to previously conducted studies for design details [36] Question: What is the latest strategy for tradipitant for gastroparesis? - Management explained the complexity of the FDA review process and that a new filing is not required at this time [39][41] Question: How long will the direct-to-consumer campaign run and how is its effectiveness measured? - Management confirmed the campaign's focus on bipolar disorder and PONVORY, noting positive feedback and increased awareness [45][46] Question: What is the market opportunity for Bisanti in major depressive disorder? - Management acknowledged that Bisanti would compete directly with CAPLYTA, emphasizing its once-daily dosing advantage [58] Question: When might the long-acting injectable formulations of Bisanti enter the clinic? - Management indicated that the long-acting injectable for Fanapt is initiating Phase III studies, while Bisanti is still in the formulation phase [61]