Core Insights - Vanda Pharmaceuticals reported a GAAP net loss of $27.2 million for Q2 2025, attributed to increased operating costs despite a 4.0% rise in GAAP revenue to $52.6 million, which fell short of analyst expectations [1][2] Financial Performance - GAAP revenue for Q2 2025 was $52.6 million, a 4.2% increase from $50.5 million in Q2 2024, but below the estimate of $54.8 million [2] - EPS (GAAP) was ($0.46), a significant decline of 475% from ($0.08) in Q2 2024 [2] - Fanapt® net product sales increased by 26.3% to $29.3 million, while HETLIOZ® and PONVORY® saw declines of 13.4% and 17.4%, respectively [2][5][6] Product Overview - Vanda Pharmaceuticals focuses on therapies for neurological and rare disorders, with key products including Fanapt®, HETLIOZ®, and PONVORY® [3] - The company is investing in direct-to-consumer marketing for Fanapt® and exploring new indications to enhance its market position [4] Cost Structure - Selling, general, and administrative costs (SG&A) reached $64.6 million, a 63.5% increase from Q2 2024, driven by larger sales teams and marketing expenditures [7] - Research and development costs rose by 32% to $21.99 million, reflecting investments in pipeline projects [7] Cash Position - Vanda ended Q2 2025 with $325.6 million in cash and equivalents, a decrease of $15.4 million from the previous quarter [8] - The company anticipates finishing fiscal 2025 with cash between $280 million and $320 million [8] Pipeline Developments - Bysanti™ has a PDUFA target action date of February 21, 2026, and is currently undergoing a pivotal Phase III trial for major depressive disorder [9][10] - Regulatory submissions for Imsidolimab and ongoing expansions for Fanapt® are planned for 2025 [11][12] Future Outlook - Vanda expects total revenues for fiscal 2025 to be between $210 million and $250 million, with continued growth anticipated for Fanapt® [14] - The company has flagged potential revenue declines for HETLIOZ® and uncertainties for other products due to market competition [14]

Core Insights - Vanda Pharmaceuticals reported a quarterly loss of $0.46 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.34, marking a surprise of -35.29% [1] - The company generated revenues of $52.59 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 4.38% [2] - Vanda has surpassed consensus EPS estimates three times over the last four quarters, indicating some volatility in earnings expectations [2] Financial Performance - The loss per share of $0.46 compares unfavorably to a loss of $0.08 per share a year ago, highlighting a significant decline in performance [1] - Year-over-year revenue increased from $50.47 million to $52.59 million, showing growth despite missing estimates [2] - The current consensus EPS estimate for the upcoming quarter is -$0.32, with expected revenues of $59.5 million, while the estimate for the current fiscal year is -$1.49 on revenues of $227.5 million [7] Market Position - Vanda shares have underperformed the market, losing about 2.5% since the beginning of the year, compared to the S&P 500's gain of 8.2% [3] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the bottom 41% of over 250 Zacks industries, suggesting a challenging environment for companies in this sector [8] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6]

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 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]