Revenue Performance - Q4 2024 total revenues reached $53.2 million, representing a 17% increase compared to Q4 2023[5] - Full year 2024 total revenues were $198.8 million, a 3% increase from $192.6 million in 2023[10] - Fanapt net product sales for Q4 2024 were $26.6 million, an 18% increase compared to Q4 2023[6] - HETLIOZ net product sales decreased by 23% to $76.7 million for the full year 2024 due to generic competition[10] - Full year 2025 revenue is expected to grow to between $210 million and $250 million[5] - Psychiatry portfolio revenue is projected to exceed $750 million by 2030[5] - Fanapt® net product sales increased to $26,649,000 in Q4 2024 from $22,599,000 in Q4 2023, representing a growth of 9.1%[26] - HETLIOZ® net product sales decreased to $20,044,000 in Q4 2024 from $21,072,000 in Q4 2023, a decline of 4.9%[26] - PONVORY® net product sales surged to $6,492,000 in Q4 2024 from $1,600,000 in Q4 2023, marking a significant increase of 304.5%[26] - Total revenues for Q4 2024 reached $53,185,000, up from $45,271,000 in Q4 2023, reflecting a growth of 17.5%[26] Expenses and Losses - Operating expenses for Q4 2024 totaled $63,464,000, compared to $52,365,000 in Q4 2023, an increase of 21.2%[26] - Vanda's net loss for Q4 2024 was $4.9 million, compared to a net loss of $2.4 million in Q4 2023[14] - Net loss for Q4 2024 was $4,912,000, compared to a net loss of $2,400,000 in Q4 2023, indicating a worsening of 104.2%[26] Cash and Assets - Cash and cash equivalents totaled $374.6 million as of December 31, 2024, a decrease of $1.6 million from the previous quarter[10] - Cash and cash equivalents decreased to $102,316,000 as of December 31, 2024, down from $135,821,000 as of December 31, 2023[28] - Total assets increased to $656,204,000 as of December 31, 2024, compared to $648,440,000 as of December 31, 2023[28] - Stockholders' equity decreased to $538,546,000 as of December 31, 2024, down from $544,910,000 as of December 31, 2023[28] - The company reported a total accumulated deficit of $174,292,000 as of December 31, 2024, compared to $155,392,000 as of December 31, 2023[28] Future Plans - Vanda submitted a New Drug Application (NDA) for Bysanti for bipolar disorder and schizophrenia expected in Q1 2025[5] - The company plans to submit a Biologics License Application (BLA) for imsidolimab in 2025 for generalized pustular psoriasis[11]

Core Insights - Vanda Pharmaceuticals reported strong revenue growth driven by its psychiatry portfolio, particularly Fanapt, Hetlioz, and Ponvory, with expectations for continued growth in 2025 and beyond [2][5][14] - The company has several key product applications pending, including Bysanti for bipolar disorder and schizophrenia, and Tradipitant for motion sickness, which are expected to contribute to future revenue growth [2][5][9] Financial Highlights - Q4 2024 total revenues reached $53.2 million, a 17% increase compared to Q4 2023 [5][6] - Full year 2024 total revenues were $198.8 million, a 3% increase compared to 2023 [5][6] - Fanapt net product sales in Q4 2024 were $26.6 million, an 18% increase from Q4 2023 [5][6] - The company expects full year 2025 revenues to grow to between $210 million and $250 million [5][14] Operational Highlights - Vanda's psychiatry portfolio is projected to exceed $750 million in revenue by 2030 [5][14] - The company initiated a Phase III program for the long-acting injectable formulation of Fanapt in Q4 2024 [11] - Vanda's acquisition of Ponvory was completed on December 7, 2023, and its commercial launch began in Q3 2024 [6][11] Key Regulatory Milestones - The NDA for Tradipitant for motion sickness was submitted in Q4 2024, with potential approval expected in 2025 [11][12] - Bysanti's NDA for bipolar disorder and schizophrenia is expected to be submitted in Q1 2025 [5][11] - The MAA for HETLIOZ for Smith-Magenis syndrome was submitted in Q4 2024 [5][11] Cash Position - As of December 31, 2024, Vanda had cash, cash equivalents, and marketable securities totaling $374.6 million, a decrease of $1.6 million from the previous quarter [6][11]

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 [5]. Upcoming Financial Results - Vanda will release its fourth quarter and full year 2024 financial results on February 13, 2025, after market close [1]. - A conference call will be held on the same day at 4:30 PM ET to discuss the financial results and other corporate activities [2]. Conference Call Details - Participants can join the conference call by dialing 1-800-715-9871 for domestic calls or 1-646-307-1963 for international calls, using passcode 2881765 [2]. - The conference call will be broadcast simultaneously and archived on Vanda's website, with investors advised to register at least 15 minutes early [3]. Replay Information - A replay of the conference call will be available starting at 8:30 PM ET on February 13, 2025, until February 20, 2025, at 11:59 PM ET [4]. - The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers, with the same passcode [4].

Core Viewpoint - Vanda Pharmaceuticals is challenging the FDA's rejection of its New Drug Application (NDA) for tradipitant, a treatment for gastroparesis, citing procedural violations and insufficient consideration of evidence [4][5][6][17]. Company Overview - Vanda Pharmaceuticals Inc. is focused on developing innovative therapies to address unmet medical needs, particularly in the field of gastroparesis, a condition with no new drug approvals in over 40 years [18]. Drug Development and Clinical Trials - Tradipitant, a neurokinin 1 receptor antagonist, has been studied for nearly a decade, with over 1,000 patients treated, including ongoing treatment through an expanded access program [3][4]. - The company conducted two placebo-controlled studies and one open-label study to assess the efficacy and safety of tradipitant [3]. FDA Review Process - The FDA rejected Vanda's NDA in September 2024, claiming that substantial evidence of efficacy was not established [4]. - Vanda argues that the FDA did not adhere to legal requirements, delaying the review process by six months and failing to provide a hearing opportunity as mandated [5][6]. Efficacy Evidence - In Study 1, tradipitant significantly improved nausea severity compared to placebo (p value = 0.0099) [9]. - Study 2 showed no statistically significant difference between tradipitant and placebo (p value = 0.7411) [10]. - Vanda conducted additional analyses suggesting tradipitant's superiority over placebo, which the FDA disputed [11]. Regulatory Standards - Vanda contends that the FDA's interpretation of the "substantial evidence" standard is overly stringent, requiring two well-controlled studies with significant results, which is not consistent with statutory language [15][16]. - The company emphasizes that the substantial evidence standard is relatively low and should allow for the approval of effective drugs, especially for conditions like gastroparesis [14][16]. Next Steps - Vanda has accepted the FDA's offer for a hearing regarding the NDA, which must commence within 120 days [17].

Core Message - Vanda Pharmaceuticals Inc has issued a letter to FDA Commissioner Robert M Califf MD highlighting concerns over the FDA's review process for its New Drug Application (NDA) for tradipitant a treatment for gastroparesis [1][2][3] FDA Review Process - Vanda submitted an NDA for tradipitant for the treatment of gastroparesis on September 18 2023 and received a Complete Response Letter (CRL) from the FDA on September 18 2024 [2][4] - The CRL was criticized by Vanda for lacking reasoned explanations and failing to engage with the evidence presented including voluminous evidence from experts [4] - Vanda expressed surprise at the disregard for facts evidence and basic scientific principles in the CRL which they argue does not reflect a legitimate regulatory review [4] FDA Advisory Committees - FDA denied Vanda's request to convene an Advisory Committee to consider the tradipitant application [5] - The number of Advisory Committee meetings convened by the FDA has drastically declined from 55% of drug applications in 2010 to 6% in 2021 [5] - FDA Commissioner Robert Califf has stated a preference for less voting by advisory committees and expressed skepticism about the value of votes which Vanda argues contributes to a lack of public scrutiny of FDA decisions [5] Communication and Accountability - Vanda wrote to Dr Nikolov expressing concerns about the CRL but received no acknowledgment or response three months later [4] - Vanda criticizes the FDA's opacity in decision-making and oversight which they argue fosters a culture of obfuscation and close-mindedness [3][4] - Vanda emphasizes the need for FDA policies practices and culture to align with scientific evidence and the law [6] Company Background - Vanda Pharmaceuticals Inc is a global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs [9]

Company Overview - Vanda Pharmaceuticals Inc (VNDA) generates revenue from three commercial products: Fanapt, Hetlioz, and Ponvory [1] - Fanapt is approved in the US for schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder [1] - Hetlioz is approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome [1] - Ponvory is an oral treatment for relapsing forms of multiple sclerosis, with US and Canada rights acquired from Actelion Pharmaceuticals Limited (a JNJ subsidiary) in December 2023 [2] Stock Performance - VNDA shares gained 13.9% in the past year, outperforming the industry's 16% decline [3] Pipeline Development - Vanda has a promising pipeline targeting neuroscience, immunology, and oncology indications [4] - Two pipeline candidates, tradipitant (for motion sickness-induced vomiting) and milsaperidone (for schizophrenia and acute bipolar I disorder), are expected to have FDA regulatory filings submitted shortly [4] - VGT-1849A, a novel antisense oligonucleotide (ASO)-based JAK2 inhibitor, received FDA Orphan Drug designation for treating polycythemia vera (PV) and other JAK2-driven hematologic malignancies [5][7] Financial Outlook - Vanda currently holds a Zacks Rank 1 (Strong Buy) [8] - Estimates for Vanda's 2025 loss per share have narrowed from 53 cents to 35 cents in the past 60 days [8] Industry Comparison - Other top-ranked biotech stocks include Puma Biotechnology Inc (PBYI) and Castle Biosciences Inc (CSTL), both with Zacks Rank 1 [9] - PBYI's 2025 EPS estimates increased from 42 cents to 54 cents in the past 60 days, despite a 38.8% share price decline over the past year [9] - CSTL's 2025 loss per share estimates narrowed from $1.88 to $1.84 in the past 60 days, with shares surging 30.9% over the past year [10] - PBYI beat earnings estimates in three of the trailing four quarters, with an average surprise of 32.78% [10] - CSTL beat earnings estimates in all four trailing quarters, with an average surprise of 172.72% [10]

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA ) is a net-net with an upcoming Q4 earnings report. I think the report has the potential to send the company's share price much higher. These two pieces of information set up a trade thatAnalyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for ...

WASHINGTON, Nov. 12, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the following upcoming investor conferences in November 2024:The Stifel 2024 Healthcare Conference on Tuesday, November 19, 2024. A corporate presentation is scheduled for 9:45 a.m. Eastern Time.The Jefferies 2024 London Healthcare Conference on Thursday, November 21, 2024. A fireside chat is scheduled for 11:30 a.m. Greenwich Mean Time (6:30 a.m. Eastern Time).The ...

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 September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |---------------------------------------------------------------------------------------------------|---------------------------------------------------- ...

Exhibit 99.1 Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results • Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 • Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges ® • Fanapt launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 • Fanapt long acting injectable program expected to be initiated in Q4 2024 ® • Milsaperidone NDA for schizophrenia and bipolar I disorde ...