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    Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

    5/7/25 4:01:00 PM ET
    $VNDA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $VNDA alert in real time by email
    • Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024
    • Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024
    • Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026
    • Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025
    • Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025

    WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the first quarter ended March 31, 2025.

    "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and development pipeline. The addition of imsidolimab alongside Ponvory establishes an anti-inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees, who for the first time surpassed 400 in number, a 22-year high."

    Financial Highlights

    • Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.0 million in the first quarter of 2025, a 5% increase compared to $47.5 million in the first quarter of 2024.
    • Fanapt® net product sales were $23.5 million in the first quarter of 2025, a 14% increase compared to $20.6 million in the first quarter of 2024.
    • HETLIOZ® net product sales were $20.9 million in the first quarter of 2025, a 4% increase compared to $20.1 million in the first quarter of 2024.
    • PONVORY® net product sales were $5.6 million in the first quarter of 2025, a decrease of 18% compared to $6.8 million in the first quarter of 2024.
    • Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of $15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities.
    • Cash, cash equivalents and marketable securities (Cash) was $340.9 million as of March 31, 2025, representing a decrease to Cash of $33.7 million compared to December 31, 2024. The decrease to Cash reflects the payment of $15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab.

    Key Operational Highlights – Commercial

    Fanapt® (iloperidone)

    • Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period.

    Fanapt® TRx and NBRx

    • Fanapt® total prescriptions (TRx) for the week of April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives.

    HETLIOZ® (tasimelteon)

    • Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2

    PONVORY® (ponesimod)

    • Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives.

    Key Operational Highlights – Regulatory & Clinical Development

    Key Regulatory Milestones

    • Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
    • Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the European Medicines Agency (EMA) in Q4 2024.
    • HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024.
    • Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026.
    • Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025.

    Key Clinical Highlights

    Fanapt® (iloperidone)

    • Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing.
    • Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon.

    Bysanti™ (milsaperidone)

    • The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s.
    • Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona.
    • The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026.

    HETLIOZ® (tasimelteon)

    • HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing.
    • Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA.

    PONVORY® (ponesimod)

    • 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.

    Tradipitant

    • The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025.
    • In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025.

    Imsidolimab

    • In February 2025, Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A 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. Vanda expects to initiate the Phase III program in 2025.
    • The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (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.

    GAAP Financial Results

    Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. Diluted net loss per share was $0.50 in the first quarter of 2025 compared to diluted net loss per share of $0.07 in the first quarter of 2024.

    2025 Financial Guidance

    Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025:

    Full Year 2025

    Financial Objectives

    Full Year 2025

    Guidance             

    Total revenues

     

    $210 to $250 million

    Year-end 2025 Cash

     

    $280 to $320 million

     

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, May 7, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9941754. A replay of the call will be available on Wednesday, May 7, 2025, beginning at 8:30 PM ET and will be accessible until Wednesday, May 14, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 9941754.

    The conference call will be broadcast simultaneously on Vanda's website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days.

    References

    1. IQVIA Prescription Data
    2. Based on blended data analysis

    About Vanda Pharmaceuticals Inc.

    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. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; Vanda's ability to obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in 2025; Vanda's ability to obtain EMA approval of the MAAs for Fanapt® and HETLIOZ® and HETLIOZ LQ®, Vanda's ability to begin enrolling patients in the Fanapt® LAI study within the specified timeframe; Vanda's ability to complete the Phase III clinical study for Bysanti™ for MDD and receive results in 2026; Vanda's ability to complete the clinical trial of tradipitant for the prevention of vomiting induced by Wegovy and receive results in the third quarter of 2025; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; and Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

    All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except for share and per share amounts)

    (unaudited)







    Three Months Ended



    March 31

    2025



    March 31

    2024

    Revenues:







    Fanapt® net product sales

    $             23,545



    $             20,579

    HETLIOZ® net product sales

    20,872



    20,053

    PONVORY® net product sales

    5,624



    6,830

    Total revenues

    50,041



    47,462

    Operating expenses:







    Cost of goods sold excluding amortization

    3,521



    3,440

    Research and development

    35,712



    21,154

    Selling, general and administrative

    50,084



    30,085

    Intangible asset amortization

    1,752



    2,018

    Total operating expenses

    91,069



    56,697

    Loss from operations

    (41,028)



    (9,235)

    Other income, net

    3,660



    4,571

    Loss before income taxes

    (37,368)



    (4,664)

    Benefit for income taxes

    (7,874)



    (518)

    Net loss

    $            (29,494)



    $              (4,146)

    Net loss per share, basic

    $                (0.50)



    $                (0.07)

    Net loss per share, diluted

    $                (0.50)



    $                (0.07)

    Weighted average shares outstanding, basic

    58,527,775



    57,760,940

    Weighted average shares outstanding, diluted

    58,527,775



    57,760,940

     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)











    March 31

    2025



    December 31

    2024

    ASSETS







    Current assets:







    Cash and cash equivalents

    $              111,796



    $              102,316

    Marketable securities

    229,112



    272,327

    Accounts receivable, net

    44,603



    47,101

    Inventory

    1,923



    1,726

    Prepaid expenses and other current assets

    20,476



    15,420

    Total current assets

    407,910



    438,890

    Property and equipment, net

    2,439



    2,132

    Operating lease right-of-use assets

    5,208



    5,602

    Finance lease right-of-use assets

    4,828



    4,943

    Intangible assets, net

    112,344



    114,096

    Deferred tax assets

    89,147



    81,440

    Non-current inventory and other

    10,060



    9,101

    Total assets

    $              631,936



    $              656,204

    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued liabilities

    $                45,279



    $                39,086

    Product revenue allowances

    58,644



    60,895

    Total current liabilities

    103,923



    99,981

    Operating lease non-current liabilities

    4,404



    4,944

    Finance lease non-current liabilities

    2,947



    3,146

    Other non-current liabilities

    9,245



    9,587

    Total liabilities

    120,519



    117,658

    Stockholders' equity:







    Common stock

    59



    58

    Additional paid-in capital

    714,761



    712,706

    Accumulated other comprehensive income

    383



    74

    Accumulated deficit

    (203,786)



    (174,292)

    Total stockholders' equity

    511,417



    538,546

    Total liabilities and stockholders' equity

    $              631,936



    $              656,204

     

    Corporate Contact:

    Kevin Moran

    Senior Vice President, Chief Financial Officer and Treasurer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    [email protected] 

    Jim Golden / Jack Kelleher / Dan Moore

    Collected Strategies

    [email protected] 

    Follow us on X @vandapharma

    Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.)

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-first-quarter-2025-financial-results-302449115.html

    SOURCE Vanda Pharmaceuticals Inc.

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    • President and CEO Polymeropoulos Mihael Hristos bought $50,150 worth of shares (10,000 units at $5.01), increasing direct ownership by 0.44% to 2,295,731 units (SEC Form 4)

      4 - Vanda Pharmaceuticals Inc. (0001347178) (Issuer)

      3/6/25 5:53:21 PM ET
      $VNDA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • President and CEO Polymeropoulos Mihael Hristos bought $50,200 worth of shares (10,000 units at $5.02), increasing direct ownership by 0.44% to 2,285,731 units (SEC Form 4)

      4 - Vanda Pharmaceuticals Inc. (0001347178) (Issuer)

      3/5/25 5:19:35 PM ET
      $VNDA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • President and CEO Polymeropoulos Mihael Hristos covered exercise/tax liability with 95,999 shares and bought $47,050 worth of shares (10,000 units at $4.71), decreasing direct ownership by 4% to 2,275,731 units (SEC Form 4)

      4 - Vanda Pharmaceuticals Inc. (0001347178) (Issuer)

      3/4/25 4:45:52 PM ET
      $VNDA
      Biotechnology: Pharmaceutical Preparations
      Health Care

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    • Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

      Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. "Vanda has entered a new g

      5/7/25 4:01:00 PM ET
      $VNDA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Vanda Pharmaceuticals to Announce First Quarter 2025 Financial Results on May 7, 2025

      Conference Call and Webcast to Follow WASHINGTON, May 2, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the first quarter 2025 on Wednesday, May 7, 2025, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, May 7, 2025, during which management will discuss the first quarter 2025 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 9941754. The conference

      5/2/25 8:46:00 AM ET
      $VNDA
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results

      Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023Full year 2025 revenue expected to grow to $210 to $250 millionPsychiatry portfolio revenue expected to grow to greater than $750 million in 2030Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024Tradipitant NDA for motion sickness submitted in Q4 2024Imsidolimab BLA in generalized pustular

      2/13/25 4:01:00 PM ET
      $VNDA
      Biotechnology: Pharmaceutical Preparations
      Health Care