1. WASHINGTON, Sept. 7, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that Vanda's management will participate at the Citi 16th Annual BioPharma Virtual Conference taking place between September 8 and September 10, 2021. Vanda management will host investor meetings. Vanda has updated its corporate presentation, which may be accessed on Vanda's website, www.vandapharma.com, by clicking on the Investors tab and following the Corporate Presentation link.

    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…

    WASHINGTON, Sept. 7, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that Vanda's management will participate at the Citi 16th Annual BioPharma Virtual Conference taking place between September 8 and September 10, 2021. Vanda management will host investor meetings. Vanda has updated its corporate presentation, which may be accessed on Vanda's website, www.vandapharma.com, by clicking on the Investors tab and following the Corporate Presentation link.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    (202) 734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    (202) 734-3400

    pr@vandapharma.com

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    SOURCE Vanda Pharmaceuticals Inc.

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  2. WASHINGTON, Aug. 3, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that enrollment has closed in the ODYSSEY study comparing tradipitant and placebo in hospitalized COVID-19 pneumonia patients.

    Enrollment was closed because the study met the pre-defined futility criteria, indicating that the study was unlikely to succeed in its pre-specified primary endpoint. The study was designed to determine whether tradipitant plus standard of care is superior to placebo plus standard of care in treating hospitalized patients with COVID-19 pneumonia who required supplemental oxygen support. The primary endpoint of the study is the difference between treatment and placebo on time to 2-point improvement on a 7-point…

    WASHINGTON, Aug. 3, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that enrollment has closed in the ODYSSEY study comparing tradipitant and placebo in hospitalized COVID-19 pneumonia patients.

    Enrollment was closed because the study met the pre-defined futility criteria, indicating that the study was unlikely to succeed in its pre-specified primary endpoint. The study was designed to determine whether tradipitant plus standard of care is superior to placebo plus standard of care in treating hospitalized patients with COVID-19 pneumonia who required supplemental oxygen support. The primary endpoint of the study is the difference between treatment and placebo on time to 2-point improvement on a 7-point ordinal scale. Treatment duration was 14 days and evaluation for the primary endpoint was at Day 28. Additional secondary endpoints include other changes in clinical and laboratory status.

    An independent data and safety monitoring board (DSMB) met to assess the planned interim analysis results. The DSMB determined that the study is unlikely to show a significant difference between treatment arms at the pre-specified primary endpoint and recommended termination of the study for futility. The DSMB also determined that there are no safety concerns that contributed to its recommendation. The ODYSSEY study was initiated in April 2020 with an enrollment goal of 324 patients of which 153 have enrolled to date.

    Separately, Vanda will continue the genetics component of the study with the goal of identifying genetic susceptibility factors contributing to the incidence of severe pneumonia among patients infected with the SARS-CoV-2 virus. In pursuit of that goal, Vanda has recently reported in the Journal of Global Antimicrobial Resistance on loss of function mutations in the IFNAR2 gene associated with COVID-19 severe infection susceptibility.1

    For more information on the trial visit clinicaltrials.gov and search NCT04326426.

    References

    1. Smieszek, S.P., Polymeropoulos, V.M., Xiao, C., Polymeropoulos, C.M., Polymeropoulos, M.H. (2021). Loss-of-function mutations in IFNAR2 in COVID-19 severe infection susceptibility. Journal of Global Antimicrobial Resistance, S2213-7165(21)00156-9. Advance online publication. https://doi.org/10.1016/j.jgar.2021.06.005

    About Tradipitant

    Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, COVID-19 pneumonia, motion sickness and atopic dermatitis. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to statements regarding Vanda's genetic analysis of SARS-CoV-2 virus patients, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, new information learned in in further analysis of ODYSSEY study data, and Vanda's ability to complete the genetics component of the study. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2020, 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.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

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    SOURCE Vanda Pharmaceuticals Inc.

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  3. WASHINGTON, July 28, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2021.

    "Vanda had another outstanding quarter of commercial revenue growth as we resumed activity across a number of our clinical programs. Our tradipitant in gastroparesis program is nearing completion, bringing us closer to a much-needed new treatment option for patients with gastroparesis and a potentially transformational commercial opportunity for Vanda," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

    Financial Highlights  

    Second Quarter of 2021

    • Total net product sales from HETLIOZ® and Fanapt® were $67.9 million in the…

    WASHINGTON, July 28, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2021.

    "Vanda had another outstanding quarter of commercial revenue growth as we resumed activity across a number of our clinical programs. Our tradipitant in gastroparesis program is nearing completion, bringing us closer to a much-needed new treatment option for patients with gastroparesis and a potentially transformational commercial opportunity for Vanda," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

    Financial Highlights  

    Second Quarter of 2021

    • Total net product sales from HETLIOZ® and Fanapt® were $67.9 million in the second quarter of 2021, a 9% increase compared to $62.2 million in the second quarter of 2020.
    • HETLIOZ® net product sales were $44.5 million in the second quarter of 2021, a 7% increase compared to $41.6 million in the second quarter of 2020.
    • Fanapt® net product sales were $23.4 million in the second quarter of 2021, a 13% increase compared to $20.6 million in the second quarter of 2020.
    • Income before taxes was $12.6 million in the second quarter of 2021 compared to $11.1 million in the second quarter of 2020.

    First Six Months of 2021

    • Total net product sales from HETLIOZ® and Fanapt® were $130.6 million in the first six months of 2021, a 9% increase compared to $120.2 million in the first six months of 2020.
    • HETLIOZ® net product sales were $83.9 million in the first six months of 2021, a 9% increase compared to $76.9 million in the first six months of 2020.
    • Fanapt® net product sales were $46.7 million in the first six months of 2021, an 8% increase compared to $43.3 million in the first six months of 2020.
    • Income before taxes was $23.0 million in the first six months of 2021 compared to $12.3 million in the first six months of 2020.
    • Cash, cash equivalents and marketable securities (Cash) was $396.5 million as of June 30, 2021, representing an increase to Cash of $56.6 million compared to June 30, 2020.

    Key Operational Highlights

    Tradipitant

    • The Phase III clinical study of tradipitant in gastroparesis is nearing completion with 95% of the target 200 patients already enrolled. Results are expected by the end of 2021.

    HETLIOZ® (tasimelteon)

    • A Phase III clinical study of HETLIOZ® in delayed sleep phase disorder (DSPD) is currently enrolling patients.

    Fanapt® (iloperidone)

    • A Phase III clinical study of Fanapt® in bipolar disorder is currently enrolling patients.
    • A clinical pharmacology study of the long acting injectable (LAI) formulation of Fanapt® is ongoing.

    Key Publications

    • The article "Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension" was published in July 2021 in Genetics in Medicine.1

    GAAP Financial Results

    Income before taxes was $12.6 million in the second quarter of 2021 compared to $11.1 million in the second quarter of 2020. Net income was $9.7 million in the second quarter of 2021 compared to net income of $8.7 million in the second quarter of 2020. Diluted net income per share was $0.17 in the second quarter of 2021 compared to diluted net income per share of $0.16 in the second quarter of 2020.

    Income before taxes was $23.0 million in the first six months of 2021 compared to $12.3 million in the first six months of 2020. Net income was $18.3 million in the first six months of 2021 compared to net income of $9.2 million in the first six months of 2020. Diluted net income per share was $0.32 in the first six months of 2021 compared to diluted net income per share of $0.17 in the first six months of 2020.

    2021 Financial Guidance

    Vanda expects to achieve the following financial objectives in 2021:

    Full Year 2021

    Financial Objectives

    Full Year 2021

    Guidance

    Total revenues

    $270 to $300 million

    HETLIOZ® net product sales

    $180 to $200 million

    Fanapt® net product sales

    $90 to $100 million

    Year-end 2021 Cash

    Greater than $400 million

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, July 28, 2021, at 4:30 PM ET. During the call, Vanda's management will discuss the second quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5298904. A replay of the call will be available on Wednesday, July 28, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, August 4, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5298904.

    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. Polymeropoulos, C.M., Brooks, J., Czeisler, E.L., Fisher, M.A., Gibson, M.M., Kite, K., Smieszek, S.P., Xiao, C., Elsea, S.H., Birznieks, G., Polymeropoulos, M.H. (2021). Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension. Genetics in Medicine. https://doi.org/10.1038/s41436-021-01282-y

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2021 Financial Guidance" above and statements regarding the clinical development and regulatory timelines and commercial potential for tradipitant 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 assumptions regarding its ability to continue to grow its business in the U.S., Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis, the prevalence of gastroparesis and Vanda's ability to successfully commercialize tradipitant. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2020, 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



    Six Months Ended



    June 30

    2021



    June 30

    2020



    June 30

    2021



    June 30

    2020

    Revenues:















    HETLIOZ® net product sales

    $

    44,509





    $

    41,561





    $

    83,852





    $

    76,897



    Fanapt® net product sales

    23,390





    20,646





    46,716





    43,310



    Total revenues

    67,899





    62,207





    130,568





    120,207



    Operating expenses:















    Cost of goods sold excluding amortization

    6,566





    5,847





    12,596





    11,054



    Research and development

    20,248





    12,903





    36,379





    28,430



    Selling, general and administrative

    28,347





    33,917





    58,144





    70,938



    Intangible asset amortization

    369





    369





    739





    739



    Total operating expenses

    55,530





    53,036





    107,858





    111,161



    Income from operations

    12,369





    9,171





    22,710





    9,046



    Other income

    235





    1,918





    322





    3,284



    Income before income taxes

    12,604





    11,089





    23,032





    12,330



    Provision for income taxes

    2,951





    2,375





    4,729





    3,130



    Net income

    $

    9,653





    $

    8,714





    $

    18,303





    $

    9,200



    Net income per share, basic

    $

    0.17





    $

    0.16





    $

    0.33





    $

    0.17



    Net income per share, diluted

    $

    0.17





    $

    0.16





    $

    0.32





    $

    0.17



    Weighted average shares outstanding, basic

    55,582,916





    54,501,308





    55,365,558





    54,153,812



    Weighted average shares outstanding, diluted

    56,903,340





    55,081,397





    56,705,419





    54,975,771





     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    June 30

    2021



    December 31

    2020

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    57,242





    $

    61,031



    Marketable securities

    339,251





    306,709



    Accounts receivable, net

    37,090





    30,036



    Inventory

    1,055





    1,280



    Prepaid expenses and other current assets

    12,014





    10,089



    Total current assets

    446,652





    409,145



    Property and equipment, net

    3,631





    4,136



    Operating lease right-of-use assets

    9,898





    10,459



    Intangible assets, net

    20,820





    21,559



    Deferred tax assets

    78,641





    81,516



    Non-current inventory and other

    8,003





    6,641



    Total assets

    $

    567,645





    $

    533,456



    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    31,788





    $

    31,509



    Product revenue allowances

    40,201





    34,427



    Total current liabilities

    71,989





    65,936



    Operating lease non-current liabilities

    10,740





    11,497



    Other non-current liabilities

    3,696





    2,757



    Total liabilities

    86,425





    80,190



    Stockholders' equity:







    Common stock

    56





    55



    Additional paid-in capital

    660,086





    650,300



    Accumulated other comprehensive income

    103





    239



    Accumulated deficit

    (179,025)





    (197,328)



    Total stockholders' equity

    481,220





    453,266



    Total liabilities and stockholders' equity

    $

    567,645





    $

    533,456



     

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

     



     

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  4. NEW YORK, July 23, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire P.C. announces the proposed settlement of the derivative action captioned In re Vanda Pharmaceuticals Inc. Derivative Litigation, Case No. 1:19-cv-04293-FB-LB in the United States District Court for the Eastern District of New York.

    If you were a stockholder of Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) as of July 19, 2021 and continue to own such shares, please click HERE to read the Notice to Current Vanda Stockholders, which contains important information regarding your rights.

    Please reach out to counsel for Plaintiffs with any questions or concerns at:

    Counsel for Plaintiffs:
    Gregory M. Nespole
    Daniel Tepper
    LEVI & KORSINSKY, LLP
    55 Broadway, 10th Floor
    New York NY 10006…

    NEW YORK, July 23, 2021 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire P.C. announces the proposed settlement of the derivative action captioned In re Vanda Pharmaceuticals Inc. Derivative Litigation, Case No. 1:19-cv-04293-FB-LB in the United States District Court for the Eastern District of New York.

    If you were a stockholder of Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) as of July 19, 2021 and continue to own such shares, please click HERE to read the Notice to Current Vanda Stockholders, which contains important information regarding your rights.

    Please reach out to counsel for Plaintiffs with any questions or concerns at:

    Counsel for Plaintiffs:

    Gregory M. Nespole

    Daniel Tepper

    LEVI & KORSINSKY, LLP

    55 Broadway, 10th Floor

    New York NY 10006

    Fax: (212) 363-7171

    W. Scott Holleman

    Garam Choe

    BRAGAR EAGEL & SQUIRE, P.C.

    810 Seventh Avenue, Suite 620

    New York, NY 10019

    Fax: (212) 486-0462



    Primary Logo

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  5. WASHINGTON, July 21, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the second quarter 2021 on Wednesday, July 28, 2021, after the market closes.

    Vanda will host a conference call at 4:30 PM ET on Wednesday, July 28, 2021, during which management will discuss the second quarter 2021 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5298904.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary…

    WASHINGTON, July 21, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the second quarter 2021 on Wednesday, July 28, 2021, after the market closes.

    Vanda will host a conference call at 4:30 PM ET on Wednesday, July 28, 2021, during which management will discuss the second quarter 2021 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5298904.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

    A replay of the call will be available on Wednesday, July 28, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, August 4, 2021, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5298904.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

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  6. WASHINGTON, May 12, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that Vanda's management will participate at the following investor conferences:

    Bank of America Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 11:00 AM ET.

    Oppenheimer Virtual Rare & Orphan Disease Summit on Friday, May 21, 2021 at 2:05 PM ET.

    Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 1:00 PM ET.

    The Bank of America, Oppenheimer, and Jefferies conferences may be accessed live on Vanda's corporate website, www.vandapharma.com.  Investors should click on the Investors tab and follow the links under Recent Events.  Investors are advised to go to the conference websites at least 15 minutes…

    WASHINGTON, May 12, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that Vanda's management will participate at the following investor conferences:

    Bank of America Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 11:00 AM ET.

    Oppenheimer Virtual Rare & Orphan Disease Summit on Friday, May 21, 2021 at 2:05 PM ET.

    Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 1:00 PM ET.

    The Bank of America, Oppenheimer, and Jefferies conferences may be accessed live on Vanda's corporate website, www.vandapharma.com.  Investors should click on the Investors tab and follow the links under Recent Events.  Investors are advised to go to the conference websites at least 15 minutes early to register, download, and install any necessary software or presentations. Links to the archived conferences will be available on Vanda's website for a period of approximately 30 days.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    (202) 734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    (202) 734-3400

    pr@vandapharma.com

     

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  7. WASHINGTON, May 5, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the first quarter ended March 31, 2021.

    "Despite seasonal and global challenges, we recorded another quarter of strong revenue across our commercial portfolio coupled with the launch of HETLIOZ® in the new indication of nighttime sleep disturbances in patients with Smith-Magenis Syndrome," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "In our clinical programs, we have made significant progress, reaching 85% randomization in our Phase III tradipitant study in gastroparesis and initiating a new clinical program for HETLIOZ® in delayed sleep phase disorder."

    Financial Highlights  

    • Total…

    WASHINGTON, May 5, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the first quarter ended March 31, 2021.

    "Despite seasonal and global challenges, we recorded another quarter of strong revenue across our commercial portfolio coupled with the launch of HETLIOZ® in the new indication of nighttime sleep disturbances in patients with Smith-Magenis Syndrome," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "In our clinical programs, we have made significant progress, reaching 85% randomization in our Phase III tradipitant study in gastroparesis and initiating a new clinical program for HETLIOZ® in delayed sleep phase disorder."

    Financial Highlights  

    • Total net product sales from HETLIOZ® and Fanapt® were $62.7 million in the first quarter of 2021, an 8% increase compared to $58.0 million in the first quarter of 2020.
    • HETLIOZ® net product sales were $39.3 million in the first quarter of 2021, an 11% increase compared to $35.3 million in the first quarter of 2020.
    • Fanapt® net product sales were $23.3 million in the first quarter of 2021, a 3% increase compared to $22.7 million in the first quarter of 2020.
    • Income before taxes was $10.4 million in the first quarter of 2021 compared to $1.2 million in the first quarter of 2020.
    • Cash, cash equivalents and marketable securities (Cash) was $378.2 million as of March 31, 2021, representing an increase to Cash of $65.8 million compared to March 31, 2020.

    Key Operational Highlights

    Tradipitant

    • The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study has a target enrollment of 200 randomized patients and is expected to complete enrollment in the second quarter of 2021, with a New Drug Application (NDA) filing expected in late 2021 or early 2022.

    HETLIOZ® (tasimelteon)

    • In December 2020, the U.S. Food and Drug Administration (FDA) approved HETLIOZ® capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).1 HETLIOZ® capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQ liquid formulation, for children with SMS, became available in the first quarter of 2021.
    • A Phase III clinical study of HETLIOZ® in delayed sleep phase disorder (DSPD) was initiated in the first quarter of 2021.

    Fanapt® (iloperidone)

    • A Phase III clinical study of Fanapt® in bipolar disorder resumed during the first quarter of 2021 after pausing in 2020 due to the COVID-19 pandemic.
    • Development of the long acting injectable (LAI) formulation of Fanapt® is ongoing.
    • A clinical development program of Fanapt® in Parkinson's disease psychosis (PDP) was initiated in the first quarter of 2021.

    GAAP Financial Results

    Income before taxes was $10.4 million in the first quarter of 2021 compared to $1.2 million in the first quarter of 2020. Net income was $8.7 million in the first quarter of 2021 compared to net income of $0.5 million in the first quarter of 2020. Diluted net income per share was $0.15 in the first quarter of 2021 compared to diluted net income per share of $0.01 in the first quarter of 2020.

    2021 Financial Guidance

    Vanda expects to achieve the following financial objectives in 2021:

    Full Year 2021

    Financial Objectives

    Full Year 2021

    Guidance

    Total revenues

    $270 to $300 million

    HETLIOZ® net product sales

    $180 to $200 million

    Fanapt® net product sales

    $90 to $100 million

    Year-end 2021 Cash

    Greater than $400 million

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, May 5, 2021, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5709209. A replay of the call will be available on Wednesday, May 5, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, May 12, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5709209.

    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. Refer to Company press release titled "FDA Approves HETLIOZ® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome" issued on December 1, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14306/pdf

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2021 Financial Guidance" above and statements regarding the clinical development and regulatory timelines for tradipitant 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 assumptions regarding its ability to continue to grow its business in the U.S. and Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2020, 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

    2021



    March 31

    2020

    Revenues:







    HETLIOZ® net product sales

    $

    39,343





    $

    35,336



    Fanapt® net product sales

    23,326





    22,664



    Total revenues

    62,669





    58,000



    Operating expenses:







    Cost of goods sold excluding amortization

    6,030





    5,207



    Research and development

    16,131





    15,527



    Selling, general and administrative

    29,797





    37,021



    Intangible asset amortization

    370





    370



    Total operating expenses

    52,328





    58,125



    Income (loss) from operations

    10,341





    (125)



    Other income

    87





    1,366



    Income before income taxes

    10,428





    1,241



    Provision for income taxes

    1,778





    755



    Net income

    $

    8,650





    $

    486



    Net income per share, basic

    $

    0.16





    $

    0.01



    Net income per share, diluted

    $

    0.15





    $

    0.01



    Weighted average shares outstanding, basic

    55,145,789





    53,806,317



    Weighted average shares outstanding, diluted

    56,505,087





    54,870,146



     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    March 31

    2021



    December 31

    2020

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    72,132





    $

    61,031



    Marketable securities

    306,030





    306,709



    Accounts receivable, net

    31,474





    30,036



    Inventory

    1,361





    1,280



    Prepaid expenses and other current assets

    10,227





    10,089



    Total current assets

    421,224





    409,145



    Property and equipment, net

    3,840





    4,136



    Operating lease right-of-use assets

    10,194





    10,459



    Intangible assets, net

    21,189





    21,559



    Deferred tax assets

    80,355





    81,516



    Non-current inventory and other

    6,389





    6,641



    Total assets

    $

    543,191





    $

    533,456



    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    26,105





    $

    31,509



    Product revenue allowances

    35,679





    34,427



    Total current liabilities

    61,784





    65,936



    Operating lease non-current liabilities

    11,125





    11,497



    Other non-current liabilities

    2,655





    2,757



    Total liabilities

    75,564





    80,190



    Stockholders' equity:







    Common stock

    56





    55



    Additional paid-in capital

    656,057





    650,300



    Accumulated other comprehensive income

    192





    239



    Accumulated deficit

    (188,678)





    (197,328)



    Total stockholders' equity

    467,627





    453,266



    Total liabilities and stockholders' equity

    $

    543,191





    $

    533,456



    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-first-quarter-2021-financial-results-301284901.html

    SOURCE Vanda Pharmaceuticals Inc.

    View Full Article Hide Full Article
  8. WASHINGTON, April 20, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the first quarter 2021 on Wednesday, May 5, 2021, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, May 5, 2021, during which management will discuss the first quarter 2021 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5709209.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary…

    WASHINGTON, April 20, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the first quarter 2021 on Wednesday, May 5, 2021, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, May 5, 2021, during which management will discuss the first quarter 2021 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5709209.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

    A replay of the call will be available on Wednesday, May 5, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, May 12, 2021, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5709209.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-first-quarter-2021-financial-results-on-may-5-2021-301273128.html

    SOURCE Vanda Pharmaceuticals Inc.

    View Full Article Hide Full Article
  9. WASHINGTON, Feb. 10, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2020.

    "I am very proud of the significant accomplishments we realized during this challenging year," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "As we look forward to the new year, it is worth noting some of our significant accomplishments from 2020: Vanda achieved record commercial revenue despite extraordinary difficulty in the field, which we believe is a testament to the value our products bring to patients; HETLIOZ® received FDA approval for nighttime sleep disturbances in patients with Smith-Magenis Syndrome; our tradipitant…

    WASHINGTON, Feb. 10, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2020.

    "I am very proud of the significant accomplishments we realized during this challenging year," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "As we look forward to the new year, it is worth noting some of our significant accomplishments from 2020: Vanda achieved record commercial revenue despite extraordinary difficulty in the field, which we believe is a testament to the value our products bring to patients; HETLIOZ® received FDA approval for nighttime sleep disturbances in patients with Smith-Magenis Syndrome; our tradipitant gastroparesis Phase III study continued recruitment; the FDA approved individual Expanded Access to tradipitant for multiple gastroparesis patients; we launched the tradipitant study for COVID-19 pneumonia; the FDA approved the Investigational New Drug application for VSJ-110 in allergic conjunctivitis; the United States Supreme Court affirmed the patent ruling on Fanapt®; and our research and development efforts advanced the clinical programs for our commercial assets as well as those in our pipeline. We look forward to another great year of accomplishments, including further revenue growth, the commercial launch of HETLIOZ® in patients with Smith-Magenis Syndrome, and the results of the tradipitant Phase III study in gastroparesis, to highlight a few."

    Key Financial and Corporate Highlights 

    Fourth Quarter of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $67.7 million in the fourth quarter of 2020, an 11% increase compared to $60.9 million in the fourth quarter of 2019.
    • HETLIOZ® net product sales were $44.2 million in the fourth quarter of 2020, a 14% increase compared to $38.6 million in the fourth quarter of 2019.
    • Fanapt® net product sales were $23.5 million in the fourth quarter of 2020, a 5% increase compared to $22.3 million in the fourth quarter of 2019.
    • Income before taxes was $10.9 million in the fourth quarter of 2020 compared to $5.8 million in the fourth quarter of 2019.

    Full Year 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $248.2 million for the full year 2020, a 9% increase compared to $227.2 million for the full year 2019.
    • HETLIOZ® net product sales were $160.7 million for the full year 2020, a 12% increase compared to $143.0 million for the full year 2019.
    • Fanapt® net product sales were $87.5 million for the full year 2020, a 4% increase compared to $84.2 million for the full year 2019.
    • Income before taxes was $31.7 million for the full year 2020 compared to $29.0 million for the full year 2019.
    • Cash, cash equivalents and marketable securities (Cash) was $367.7 million as of December 31, 2020, representing an increase to Cash of $55.6 million compared to December 31, 2019.

    Key Product and Pipeline Highlights

    Products

    Vanda is encouraged by the strength of its commercial performance during the fourth quarter of 2020. Vanda continues to implement marketing and sales strategies aimed at supporting growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the Fanapt® for schizophrenia direct-to-consumer campaign, which was launched in 2020. Vanda is continuing its activities to support and facilitate the treatment of individuals in the U.S. living with Smith-Magenis Syndrome (SMS), and is committed to its awareness campaign and the support of patients suffering with Non-24-Hour Sleep-Wake Disorder.

    Pipeline

    Tradipitant

    • The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study has a target enrollment of 200 randomized patients and is expected to complete enrollment in the first half of 2021, with a New Drug Application (NDA) filing projected in the second half of 2021.
    • The COVID-19 pneumonia Phase III clinical study (ODYSSEY VLY-686-3501) is ongoing.

    HETLIOZ® (tasimelteon)

    • In December 2020, the U.S. Food and Drug Administration (FDA) approved HETLIOZ® capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in SMS.1 HETLIOZ® capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021. SMS is estimated to affect 1/15,000-25,000 births in the U.S.2 HETLIOZ® is the first and only FDA approved medication for patients with SMS.
    • A Phase III clinical study for HETLIOZ® in delayed sleep phase disorder (DSPD) is expected to be initiated in the first quarter of 2021.
    • A clinical development program for HETLIOZ® in autism spectrum disorder (ASD) is expected to be initiated in the first quarter of 2021.

    Fanapt® (iloperidone)

    • Development of the long acting injectable (LAI) formulation of Fanapt® is ongoing.
    • A clinical program for Fanapt® in Parkinson's disease psychosis (PDP) is expected to begin in the first quarter of 2021.

    GAAP Financial Results

    Income before taxes was $10.9 million in the fourth quarter of 2020 compared to $5.8 million in the fourth quarter of 2019. Net income was $8.2 million in the fourth quarter of 2020 compared to net income of $4.2 million in the fourth quarter of 2019. Diluted net income per share was $0.15 in the fourth quarter of 2020 compared to diluted net income per share of $0.08 in the fourth quarter of 2019.

    Income before taxes was $31.7 million for the full year 2020 compared to $29.0 million for the full year 2019. Net income was $23.3 million for the full year 2020 compared to net income of $115.6 million for the full year 2019. The full year 2019 net income of $115.6 million and the 2019 income tax benefit of $86.5 million include the favorable impact of the release of Vanda's deferred tax asset valuation allowance.

    Diluted net income per share was $0.42 for the full year 2020 compared to diluted net income per share of $2.11 for the full year 2019.

    2021 Financial Guidance

    Vanda expects to achieve the following financial objectives in 2021:

    Full Year 2021

    Financial Objectives

    Full Year 2021

    Guidance

    Total revenues

    $270 to $300 million

    HETLIOZ® net product sales

    $180 to $200 million

    Fanapt® net product sales

    $90 to $100 million

    Year-end 2021 Cash

    Greater than $400 million

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, February 10, 2021, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 3557867. A replay of the call will be available on Wednesday, February 10, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, February 17, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 3557867.

    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. Refer to Company press release titled "FDA Approves HETLIOZ® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome" issued on December 1, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14306/pdf
    2. Orphanet ORPHA number 819.

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2021 Financial Guidance" above and statements regarding Vanda's revenue expectations for 2021, the commercial launch of HETLIOZ® for the treatment of patients with SMS, Vanda's marketing and sales strategies, the expected availability of the HETLIOZ LQTM liquid formulation and the clinical development and regulatory timelines for tradipitant, HETLIOZ® and Fanapt®, 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 assumptions regarding its ability to continue to grow its business in the U.S., the ability of Vanda's third-party manufacturer to timely provide Vanda with a supply of the HETLIOZ LQTM liquid formulation, and Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis and COVID-19 pneumonia, HETLIOZ® in the treatment of DSPD and ASD, Fanapt® LAI in the treatment of schizophrenia, and Fanapt® in the treatment of PDP. Therefore, no assurance can be given that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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



    Twelve Months Ended



    December 31

    2020



    December 31

    2019



    December 31

    2020



    December 31

    2019

    Revenues:















    HETLIOZ® net product sales

    $

    44,171





    $

    38,599





    $

    160,686





    $

    142,980



    Fanapt® net product sales

    23,482





    22,331





    87,482





    84,208



    Total revenues

    67,653





    60,930





    248,168





    227,188



    Operating expenses:















    Cost of goods sold excluding amortization

    6,412





    6,225





    23,364





    24,488



    Research and development

    14,849





    13,074





    55,577





    48,649



    Selling, general and administrative

    35,571





    37,018





    140,510





    129,736



    Intangible asset amortization

    370





    370





    1,478





    1,505



    Total operating expenses

    57,202





    56,687





    220,929





    204,378



    Income from operations

    10,451





    4,243





    27,239





    22,810



    Other income

    473





    1,567





    4,416





    6,218



    Income before income taxes

    10,924





    5,810





    31,655





    29,028



    Provision (benefit) for income taxes

    2,734





    1,594





    8,318





    (86,525)



    Net income

    $

    8,190





    $

    4,216





    $

    23,337





    $

    115,553



    Net income per share, basic

    $

    0.15





    $

    0.08





    $

    0.43





    $

    2.17



    Net income per share, diluted

    $

    0.15





    $

    0.08





    $

    0.42





    $

    2.11



    Weighted average shares outstanding, basic

    54,731,042





    53,389,950





    54,427,683





    53,137,562



    Weighted average shares outstanding, diluted

    55,596,697





    54,973,952





    55,190,802





    54,847,060



     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    December 31

    2020



    December 31

    2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    61,031





    $

    45,072



    Marketable securities

    306,709





    267,057



    Accounts receivable, net

    30,036





    26,367



    Inventory

    1,280





    1,140



    Prepaid expenses and other current assets

    10,089





    14,500



    Total current assets

    409,145





    354,136



    Property and equipment, net

    4,136





    3,864



    Operating lease right-of-use assets

    10,459





    11,180



    Intangible assets, net

    21,559





    23,037



    Deferred tax assets

    81,516





    87,680



    Non-current inventory and other

    6,641





    3,851



    Total assets

    $

    533,456





    $

    483,748



    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    31,509





    $

    27,590



    Product revenue allowances

    34,427





    31,915



    Total current liabilities

    65,936





    59,505



    Operating lease non-current liabilities

    11,497





    12,455



    Other non-current liabilities

    2,757





    843



    Total liabilities

    80,190





    72,803



    Stockholders' equity:







    Common stock

    55





    54



    Additional paid-in capital

    650,300





    631,307



    Accumulated other comprehensive income

    239





    249



    Accumulated deficit

    (197,328)





    (220,665)



    Total stockholders' equity

    453,266





    410,945



    Total liabilities and stockholders' equity

    $

    533,456





    $

    483,748



     

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-fourth-quarter-and-full-year-2020-financial-results-301226341.html

    SOURCE Vanda Pharmaceuticals Inc.

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  10. WASHINGTON, Feb. 2, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the fourth quarter and full year 2020 on Wednesday, February 10, 2021, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, February 10, 2021, during which management will discuss the fourth quarter and full year 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 3557867.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register…

    WASHINGTON, Feb. 2, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the fourth quarter and full year 2020 on Wednesday, February 10, 2021, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, February 10, 2021, during which management will discuss the fourth quarter and full year 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 3557867.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

    A replay of the call will be available on Wednesday, February 10, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, February 17, 2021, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 3557867.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-fourth-quarter-and-full-year-2020-financial-results-on-february-10-2021-301220624.html

    SOURCE Vanda Pharmaceuticals Inc.

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  11. WASHINGTON, Dec. 1, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ® (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). SMS is a rare neurodevelopmental disorder, a defining feature of which is an "inverted" circadian rhythm, making it extremely difficult for patients with SMS to sleep during the night. HETLIOZ® is the first FDA-approved medication for patients with SMS.

    "The FDA approval of HETLIOZ® for the treatment of nighttime sleep disturbances in SMS would not have been accomplished without the heroic…

    WASHINGTON, Dec. 1, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ® (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). SMS is a rare neurodevelopmental disorder, a defining feature of which is an "inverted" circadian rhythm, making it extremely difficult for patients with SMS to sleep during the night. HETLIOZ® is the first FDA-approved medication for patients with SMS.

    "The FDA approval of HETLIOZ® for the treatment of nighttime sleep disturbances in SMS would not have been accomplished without the heroic efforts of SMS patients and the efforts of their families and advocates supporting the recruitment, design, and conduct of the study," said Mihael H. Polymeropoulos M.D., Vanda's President and CEO. "We remain committed to providing this much needed therapy to patients with SMS."

    The approval of HETLIOZ® for the treatment of nighttime sleep disturbances in SMS was based on a single placebo-controlled efficacy study in this rare disorder, which studied both adults with SMS taking the HETLIOZ® capsule and children with SMS taking the liquid formulation. The safety profile of HETLIOZ® in this study was similar to those seen in HETLIOZ® studies previously conducted for the treatment of Non-24-Hour Sleep-Wake Disorder, and was similar between adults and children with SMS.

    "We are very excited to see HETLIOZ®, the first ever treatment approved for people with SMS, addressing the significant problem of sleep disturbances and we are happy to see this treatment used in our community," said Maggie Miller, Co-Founder and Vice President of PRISMS (Parents and Researchers Interested in Smith-Magenis Syndrome).  "We thank Vanda and the FDA for partnering to help our community and we look forward to continued partnership to bring this important therapy to families with SMS."

    HETLIOZ® capsules, for adults with SMS, will be immediately available and the HETLIOZ LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021.

    About Smith-Magenis Syndrome

    Smith-Magenis Syndrome (SMS) is a developmental disorder that is caused by a small deletion of human chromosome 17p 1,2. In more rare cases SMS is caused by a point mutation in the RAI1 gene which resides in the deleted region. SMS is estimated to affect 1/15,000-25,000 births in the U.S.3  SMS is usually not inherited but rather is due to a de-novo deletion. Patients with SMS present with a number of physical, mental and behavioral problems. The most common symptom of SMS is a severe sleep disorder associated with significant disruption in the lives of patients and their families. 

    References:

    1. Williams, S. R., Zies, D., Mullegama, S. V, Grotewiel, M. S., & Elsea, S. H. (2012). Smith-Magenis syndrome results in disruption of CLOCK gene transcription and reveals an integral role for RAI1 in the maintenance of circadian rhythmicity. Am.J Hum.Genet., 90(1537–6605), 941–949.
    2. Gropman, A. L., Duncan, W. C., & Smith, A. C. (2006). Neurologic and developmental features of the Smith-Magenis syndrome (del 17p11.2). Pediatr.Neurol., 34(0887–8994), 337–350. 
    3. Orphanet ORPHA number 819.

    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 Twitter @vandapharma.

    About HETLIOZ®

    HETLIOZ® (tasimelteon) is a melatonin receptor agonist. HETLIOZ® has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency. For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this release, including, but not limited to statements regarding Vanda's ability to make HETLIOZ® available to patients with nighttime sleep disturbances in SMS, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, market acceptance of HETLIOZ® as a treatment of SMS in adults and children, Vanda's dependence on third-party manufacturers to manufacture HETLIOZ® in sufficient quantities and quality, and Vanda's sales and marketing infrastructure. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Cision View original content:http://www.prnewswire.com/news-releases/fda-approves-hetlioz-tasimelteon-for-the-treatment-of-nighttime-sleep-disturbances-in-smith-magenis-syndrome-301183162.html

    SOURCE Vanda Pharmaceuticals Inc.

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  12. WASHINGTON, Oct. 28, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the third quarter ended September 30, 2020.

    "Vanda continued to deliver strong commercial performance in the third quarter, despite the ongoing COVID-19 pandemic, while at the same time we advanced our robust clinical development pipeline," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights 

    Third Quarter of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $60.3 million in the third quarter of 2020, a 1% increase compared to $59.5 million in the third quarter of 2019.
    • HETLIOZ® net product sales were $39.6 million in the third quarter of…

    WASHINGTON, Oct. 28, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced financial and operational results for the third quarter ended September 30, 2020.

    "Vanda continued to deliver strong commercial performance in the third quarter, despite the ongoing COVID-19 pandemic, while at the same time we advanced our robust clinical development pipeline," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights 

    Third Quarter of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $60.3 million in the third quarter of 2020, a 1% increase compared to $59.5 million in the third quarter of 2019.
    • HETLIOZ® net product sales were $39.6 million in the third quarter of 2020, a 5% increase compared to $37.6 million in the third quarter of 2019.
    • Fanapt® net product sales were $20.7 million in the third quarter of 2020, a 6% decrease compared to $21.9 million in the third quarter of 2019.
    • Income before taxes was $8.4 million in the third quarter of 2020 compared to $12.3 million in the third quarter of 2019.

    First Nine Months of 2020

    • Total net product sales from HETLIOZ® and Fanapt® were $180.5 million in the first nine months of 2020, a 9% increase compared to $166.3 million in the same period in 2019.
    • HETLIOZ® net product sales were $116.5 million in the first nine months of 2020, a 12% increase compared to $104.4 million in the same period in 2019.
    • Fanapt® net product sales were $64.0 million in the first nine months of 2020, a 3% increase compared to $61.9 million in the same period in 2019.
    • Income before taxes was $20.7 million in the first nine months of 2020 compared to $23.2 million in the same period in 2019.
    • Cash, cash equivalents and marketable securities (Cash) were $348.5 million as of September 30, 2020, representing an increase to Cash of $48.9 million compared to September 30, 2019.

    Key Product and Pipeline Highlights

    Products

    Vanda is encouraged by the strength of its commercial performance during the third quarter of 2020 despite the COVID-19 pandemic. Vanda continues to implement marketing and sales strategies aimed at supporting continued growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the Fanapt® for schizophrenia direct-to-consumer campaign, which was launched at the end of the second quarter of 2020.

    Pipeline

    The COVID-19 pandemic has impacted clinical research globally, including some of Vanda's previously reported clinical trials. The tradipitant gastroparesis program has resumed patient enrollment, while randomization for the tradipitant motion sickness and atopic dermatitis programs, as well as the Fanapt® bipolar disorder and long acting injectable studies, is currently on hold.

    Tradipitant

    • The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study reached 50% enrollment towards a target of 200 randomized patients and is expected to complete enrollment in the first half of 2021 with a New Drug Application (NDA) filing projected for later that year.
    • Interim analysis from the Phase III clinical study (ODYSSEY VLY-686-3501) shows that tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia.1 Vanda continues to recruit patients for this study.

    HETLIOZ® (tasimelteon)

    • The Smith-Magenis Syndrome (SMS) marketing authorization applications were accepted by the U.S. Food and Drug Administration (FDA) for priority review with a Prescription Drug User Fee Act (PDUFA-VI) target action date of December 1, 2020.2

    VSJ-110 (previously known as CFTRact-K267)

    • The Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 for the treatment of allergic conjunctivitis was approved by the FDA.3

    Key Publications

    • The article "Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study" was published in the September 2020 issue of Frontiers in Neurology.4

    GAAP Financial Results

    Income before taxes was $8.4 million in the third quarter of 2020 compared to $12.3 million in the third quarter of 2019. Net income was $5.9 million in the third quarter of 2020, compared to net income of $100.4 million in the third quarter of 2019. Diluted net income per share was $0.11 in the third quarter of 2020, compared to diluted net income per share of $1.84 in the third quarter of 2019.

    Income before taxes was $20.7 million in the first nine months of 2020 compared to $23.2 million in the same period in 2019. Net income was $15.1 million in the first nine months of 2020, compared to net income of $111.3 million in the same period in 2019. Diluted net income per share was $0.28 in the first nine months of 2020, compared to diluted net income per share of $2.03 in the same period in 2019.

    The income tax benefit of $88.1 million reflected in the financial results for both the third quarter of 2019 and the first nine months of 2019 includes the favorable impact of the release of Vanda's deferred tax asset valuation allowance.

    2020 Financial Guidance

    Vanda will continue to assess the impact of the evolving pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance previously communicated by Vanda is shown below.

    Full Year 2020

    Financial Objectives

    Full Year 2020

    Guidance

    Total revenues

    $240 to $260 million

    HETLIOZ® net product sales

    $155 to $165 million

    Fanapt® net product sales

    $85 to $95 million

    Year-end 2020 Cash

    Greater than $340 million

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, October 28, 2020, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 8971955. A replay of the call will be available on Wednesday, October 28, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, November 4, 2020 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 8971955.

    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. Refer to Company press release titled "Vanda Pharmaceuticals' Interim Analysis from ODYSSEY Study Shows Tradipitant may Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia" issued on August 18, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14256/pdf
    2. Refer to Company press release titled "FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome" issued on August 3, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14226/pdf
    3. Refer to Company press release titled "Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VSJ-110 for Allergic Conjunctivitis" issued on October 26, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14286/pdf
    4. Polymeropoulos, V.M., Czeisler, M.E., Gibson, M.M., Anderson, A.A., Miglo, J., Wang, J., Xiao, C., Polymeropoulos, C.M., Birznieks, G., & Polymeropoulos, M. H. (2020). Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. Frontiers in Neurology, 11, p. 563373. https://doi.org/10.3389/fneur.2020.563373

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2020 Financial Guidance" above and statements regarding Vanda's marketing and sales strategies, recruitment for the gastroparesis and ODYSSEY studies, the interim analysis from the ODYSSEY study and clinical development and regulatory timelines for tradipitant and HETLIOZ® are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions 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 assumptions regarding its ability to continue to grow its business in the U.S.; Vanda's ability to minimize the disruption caused by, and maintain business continuity during, the global COVID-19 pandemic and related market volatility; the duration and severity of the global COVID-19 pandemic, including prevailing economic conditions and general uncertainties relating thereto that may be unknown and unforeseeable; Vanda's ability to enroll patients in and complete its gastroparesis and ODYSSEY studies; Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis, motion sickness, atopic dermatitis and COVID-19 pneumonia; Vanda's ability to successfully resume the clinical programs that are currently on hold; and the FDA's ability to complete its review of the HETLIOZ® applications for the treatment of SMS on time and make the determination that HETLIOZ® is safe and effective in the treatment of SMS in adults and children. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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



    Nine Months Ended



    September 30

    2020



    September 30

    2019



    September 30

    2020



    September 30

    2019

    Revenues:















    HETLIOZ® net product sales

    $

    39,618





    $

    37,589





    $

    116,515





    $

    104,381



    Fanapt® net product sales

    20,690





    21,896





    64,000





    61,877



    Total revenues

    60,308





    59,485





    180,515





    166,258



    Operating expenses:















    Cost of goods sold excluding amortization

    5,898





    6,782





    16,952





    18,263



    Research and development

    12,298





    11,347





    40,728





    35,575



    Selling, general and administrative

    34,001





    30,221





    104,939





    92,718



    Intangible asset amortization

    369





    376





    1,108





    1,135



    Total operating expenses

    52,566





    48,726





    163,727





    147,691



    Income from operations

    7,742





    10,759





    16,788





    18,567



    Other income

    659





    1,517





    3,943





    4,651



    Income before income taxes

    8,401





    12,276





    20,731





    23,218



    Provision (benefit) for income taxes

    2,454





    (88,147)





    5,584





    (88,119)



    Net income

    $

    5,947





    $

    100,423





    $

    15,147





    $

    111,337



    Net income per share, basic

    $

    0.11





    $

    1.88





    $

    0.28





    $

    2.10



    Net income per share, diluted

    $

    0.11





    $

    1.84





    $

    0.28





    $

    2.03



    Weighted average shares outstanding, basic

    54,666,128





    53,297,298





    54,325,832





    53,052,521



    Weighted average shares outstanding, diluted

    55,209,032





    54,541,625





    55,054,772





    54,803,851



     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    September 30

    2020



    December 31

    2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    56,973





    $

    45,072



    Marketable securities

    291,575





    267,057



    Accounts receivable, net

    28,033





    26,367



    Inventory

    1,322





    1,140



    Prepaid expenses and other current assets

    11,631





    14,500



    Total current assets

    389,534





    354,136



    Property and equipment, net

    3,921





    3,864



    Operating lease right-of-use assets

    10,306





    11,180



    Intangible assets, net

    21,929





    23,037



    Deferred tax assets

    83,858





    87,680



    Non-current inventory and other

    6,357





    3,851



    Total assets

    $

    515,905





    $

    483,748



    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    29,086





    $

    27,590



    Product revenue allowances

    32,273





    31,915



    Total current liabilities

    61,359





    59,505



    Operating lease non-current liabilities

    11,559





    12,455



    Other non-current liabilities

    2,415





    843



    Total liabilities

    75,333





    72,803



    Stockholders' equity:







    Common stock

    55





    54



    Additional paid-in capital

    645,656





    631,307



    Accumulated other comprehensive income

    379





    249



    Accumulated deficit

    (205,518)





    (220,665)



    Total stockholders' equity

    440,572





    410,945



    Total liabilities and stockholders' equity

    $

    515,905





    $

    483,748



    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2020-financial-results-301162148.html

    SOURCE Vanda Pharmaceuticals Inc.

    View Full Article Hide Full Article
  13. WASHINGTON, Oct. 26, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 (previously known as CFTRact-K267) for the treatment of allergic conjunctivitis.

    "This is an exciting milestone in the course of our collaboration with University of California, San Francisco (UCSF) and Dr. Alan Verkman towards the development of human therapeutics targeting the Cystic Fibrosis Transmembrane Conductance Regulator," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.  "Initiation of the clinical program for VSJ-110…

    WASHINGTON, Oct. 26, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 (previously known as CFTRact-K267) for the treatment of allergic conjunctivitis.

    "This is an exciting milestone in the course of our collaboration with University of California, San Francisco (UCSF) and Dr. Alan Verkman towards the development of human therapeutics targeting the Cystic Fibrosis Transmembrane Conductance Regulator," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.  "Initiation of the clinical program for VSJ-110 marks the beginning of Vanda's development of therapeutics in ophthalmology exploring the compound's novel dual anti-inflammatory and prosecretory mechanism of action."

    The initial Phase II study in human volunteers will evaluate the acute anti-inflammatory effects of VSJ-110 in an ocular allergic challenge model, and will evaluate the prosecretory effects using standard tear production assessments.

    The results from this Phase II study will help guide further development of VSJ-110 to treat a variety of ocular inflammatory conditions, including dry eye, which has an estimated worldwide prevalence of 5-20%, with about 16 million affected individuals in the United States.1 Other potential indications include chronic inflammatory eye conditions, such as atopic keratoconjunctivitis, which remain poorly addressed with current treatment options.2

    "Studies in experimental animal models already provide in vivo evidence for the efficacy of CFTRact-K267 (VSJ-110) in stimulating chloride secretion and reversing corneal epithelial injury in dry eye," said Alan Verkman, M.D., Ph.D., Professor of Medicine at UCSF.

    "It is exciting to see Vanda pursue a unique and novel therapeutic mechanism of action to address common inflammatory eye conditions that impact such a significant number of patients," said Julie Schallhorn, M.D., M.S., Assistant Professor of Ophthalmology at UCSF. "The mechanism of action of VSJ-110, that could address both the aqueous deficiency and inflammatory components of dry eye disease, has the potential to revolutionize how we care for dry eye patients."

    Vanda plans to initiate enrollment in the Phase II study by the end of 2020 and anticipates results of this study in 2021.

    About VSJ-11

    VSJ-110 is a small molecule nanomolar potency CFTR activator. VSJ-110 has shown efficacy in a dry eye model3 and exhibited anti-inflammatory properties in both in vitro and in vivo assays.

    Vanda entered into a license agreement with UCSF in 2017, under which Vanda acquired an exclusive worldwide license from UCSF to develop and commercialize a portfolio of CFTR activators and inhibitors, including VSJ-110. CFTR activators and inhibitors may have broad applicability in addressing a number of disorders, including chronic dry eye, constipation, polycystic kidney disease, cholestasis, and secretory diarrheas.

    References

    1. Stapleton, F., Alves, M., Bunya, V. Y., Jalbert, I., Lekhanont, K., Malet, F., Na, K. S., Schaumberg, D., Uchino, M., Vehof, J., Viso, E., Vitale, S., & Jones, L. (2017). TFOS DEWS II Epidemiology Report. The ocular surface, 15(3), 334–365. https://doi.org/10.1016/j.jtos.2017.05.003
    2. Pedram, H., Reza, D. (2019, September). Vernal keratoconjunctivitis. UpToDate. https://www.uptodate.com/contents/vernal-keratoconjunctivitis.
    3. Chen, X., Lee, S., Zhang, T., Duan, T., Pasricha, N. D., Schallhorn, J. M., Levin, M. H., Koprivica, V., & Verkman, A. S. (2020). Nanomolar Potency Aminophenyltriazine CFTR Activator Reverses Corneal Epithelial Injury in a Mouse Model of Dry Eye. Journal of ocular pharmacology and therapeutics: the official journal of the Association for Ocular Pharmacology and Therapeutics, 36(3), 147–153. https://doi.org/10.1089/jop.2019.0087

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to statements regarding the VSJ-110 clinical development program, the timeline and anticipated findings of the VSJ-110 Phase II study, the potential for VSJ-110 to be a safe and effective treatment for patients with allergic conjunctivitis, dry eye and atopic keratoconjunctivitis, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions 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 enroll patients for, and successfully conduct, the VSJ-110 Phase II study for the treatment of allergic conjunctivitis in the midst of the global COVID-19 pandemic; Vanda's ability to enroll patients for, and successfully conduct, studies of VSJ-110 in additional indications; Vanda's ability to complete the clinical development of and obtain regulatory approval of VSJ-110 for the treatment of allergic conjunctivitis and additional indications. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

     

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-receives-fda-approval-to-proceed-with-investigational-new-drug-vsj-110-for-allergic-conjunctivitis-301159858.html

    SOURCE Vanda Pharmaceuticals Inc.

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  14. WASHINGTON, Oct. 21, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the third quarter 2020 on Wednesday, October 28, 2020, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, October 28, 2020, during which management will discuss the third quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 8971955.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any…

    WASHINGTON, Oct. 21, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the third quarter 2020 on Wednesday, October 28, 2020, after the market closes.  

    Vanda will host a conference call at 4:30 PM ET on Wednesday, October 28, 2020, during which management will discuss the third quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 8971955.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

    A replay of the call will be available on Wednesday, October 28, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, November 4, 2020, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 8971955.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-third-quarter-2020-financial-results-on-october-28-2020-301157388.html

    SOURCE Vanda Pharmaceuticals Inc.

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  15. Appointment Adds Two Additional Independent, Highly Qualified, Diverse Directors

    Spectrum Brands Holdings, Inc. (NYSE:SPB, "Spectrum Brands" or the "Company"))), a leading global branded consumer products and home essentials company focused on driving innovation and providing exceptional customer service, today announced the appointments of Gautam Patel and Anne S. Ward to its Board of Directors, each an independent, highly qualified, and diverse background candidate.

    "We are very pleased to welcome Gautam and Anne as our new independent directors. They join our team during an exciting time as a home essentials company. We look forward to drawing on Gautam's extensive knowledge in mergers and acquisitions, financings, and investments across…

    Appointment Adds Two Additional Independent, Highly Qualified, Diverse Directors

    Spectrum Brands Holdings, Inc. (NYSE:SPB, "Spectrum Brands" or the "Company"))), a leading global branded consumer products and home essentials company focused on driving innovation and providing exceptional customer service, today announced the appointments of Gautam Patel and Anne S. Ward to its Board of Directors, each an independent, highly qualified, and diverse background candidate.

    "We are very pleased to welcome Gautam and Anne as our new independent directors. They join our team during an exciting time as a home essentials company. We look forward to drawing on Gautam's extensive knowledge in mergers and acquisitions, financings, and investments across a broad range of sectors and Anne's extensive knowledge in personal care and home essential products across a broad range of consumer brands. Their backgrounds and experiences complement and enhance the skillset of our Board and provide additional resources to our management team. Their additions to our Board also reflect the dialogue we had with our shareholders and our commitment to having a highly skilled Board with a significant variety of expertise and experiences and diversity across race, gender, and ethnicity," said David Maura, Chairman and Chief Executive Offer of Spectrum Brands.

    In addition, as part of the Company's shareholder engagement program and its commitment to improved corporate governance, the Board also adopted a Board Diversity Policy. A copy of this policy can be found on the Company's website at www.spectrumbrands.com under "Investor Relations-Corporate Governance Documents".

    Mr. Gautam Patel, age 48, serves as Managing Director of Tarsadia Investments, a private investment firm based in Newport Beach, California, which he joined in 2012. In that role, Mr. Patel has led a team of investment professionals to identify, evaluate, and execute principal control equity investments across sectors including life sciences, financial services, and technology. Prior to joining Tarsadia in 2012, Mr. Patel served as Managing Director at Lazard, where he led financial and strategic advisory efforts in sectors including transportation and logistics, private equity, and healthcare. Mr. Patel joined Lazard as an associate in 1999, after graduating from business school. From 1994 to 1997, Mr. Patel was an Analyst at Donaldson, Lufkin & Jenrette, where he worked on mergers and acquisitions as well as high-yield and equity financings. Mr. Patel is currently a Board Member of Amneal Pharmaceuticals (NYSE:AMRX) as well as several private companies including Kashiv Biosciences, Asana Biosciences, Prolong Pharmaceuticals, LERETA and AIONX Antimicrobial Technologies. Mr. Patel also serves on the board of Casita Maria Center for Arts and Education, a New York based non-profit organization which aims to empower children through arts based education. Mr. Patel received a B.A. from Claremont McKenna College, a B.S. from Harvey Mudd College, an MSc from the London School of Economics and an MBA from the University of Chicago.

    Ms. Anne Ward, age 48, currently serves as the Chief Executive Officer of CURiO Brands, a privately-held consumer goods company that manufactures and sells a portfolio of personal care and home fragrance brands. She joined the company in April 2012 as the CEO of Thymes and subsequently led a merger with DPM Fragrance to form CURiO. Prior to CURiO, Ms. Ward founded The FORWARD Group, a consulting firm focused on developing growth strategies for mid-sized companies and key executives, and served as its CEO from July 2010 until April 2012. From October 2007 until July 2010, Ms. Ward was the President and Chief Operating Officer of Johnson Publishing Company where she led the Ebony, Jet and Fashion Fair Cosmetics business units. Prior to her role at Johnson Publishing Company, Ms. Ward served as an Assistant Vice President of marketing for The Coca-Cola Company from September 2006 until September 2007 leading growth strategies for Coca-Cola, Sprite, Dasani and other key brands. Ms. Ward also held several positions of increasing responsibility within manufacturing and brand management at Procter & Gamble between May 1994 and August 2006. She led well-established, global brands including Pampers and Clairol as well as consumer growth strategies for the Beauty division. Ms. Ward currently serves as a Board Member of Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA). She holds a B.S. in Mechanical Engineering and Material Science from Duke University and an M.B.A. from Duke University's Fuqua School of Business.

    About Spectrum Brands Holdings, Inc.

    Spectrum Brands Holdings, a member of the Russell 1000 Index, is a leading supplier of residential locksets, residential builders' hardware, plumbing, shaving and grooming products, personal care products, small household appliances, specialty pet supplies, lawn and garden and home pest control products, and personal insect repellents. Helping to meet the needs of consumers worldwide, Spectrum Brands offers a broad portfolio of market-leading, well-known and widely trusted brands including Kwikset®, Weiser®, Baldwin®, National Hardware®, Pfister®, Remington®, George Foreman®, Russell Hobbs®, Black+Decker®, Tetra®, Marineland®, Nature's Miracle®, Dingo®, 8-in-1®, FURminator®, IAMS® and Eukanuba® (Europe only), Digest-eeze™, Healthy-Hide®, Littermaid®, Spectracide®, Cutter®, Repel®, Hot Shot®, Black Flag® and Liquid Fence®. For more information, please visit www.spectrumbrands.com. Spectrum Brands – A Home Essentials Company.

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  16. WASHINGTON, Aug. 31, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today provided an update on its development program for tradipitant.

    • Enrollment in Vanda's Phase III clinical study (VP-VLY-686-3303) in gastroparesis is expected to be completed in the first half of 2021
    • The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology1
    • A new gastroparesis therapy could present a significant commercial opportunity, with an estimated 6 million people in the U.S. suffering from gastroparesis
    • Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with…

    WASHINGTON, Aug. 31, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today provided an update on its development program for tradipitant.

    • Enrollment in Vanda's Phase III clinical study (VP-VLY-686-3303) in gastroparesis is expected to be completed in the first half of 2021
    • The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology1
    • A new gastroparesis therapy could present a significant commercial opportunity, with an estimated 6 million people in the U.S. suffering from gastroparesis
    • Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia2
    • Vanda is pursuing multiple short-term and long-term indications for tradipitant, including treatment of gastroparesis, COVID-19 pneumonia, motion sickness, and atopic dermatitis

    Clinical progress of tradipitant in gastroparesis

    Tradipitant is advancing in a Phase III study for the treatment of both diabetic and idiopathic gastroparesis.  This study is 30% enrolled at a target of 200 randomized patients, and is expected to complete enrollment in the first half of 2021.  The previous Phase II study showed significant improvement in nausea, the key symptom of gastroparesis, as well as significant improvement in the number of nausea-free days, in patients treated with 85 mg of tradipitant twice a day for 4 weeks.  The Phase III study is a 12-week study of similar design to the Phase II study in both target population and endpoints. 

    The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in Gastroenterology.  A preprint is available online here.  The article describes the results of Vanda's Phase II double-blind trial of 152 adults with gastroparesis at 47 sites in the U.S. from November 2016 through December 2018.  Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (p=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; p=.0160). Patients with nausea and vomiting at baseline (n=101) had an even greater decrease in nausea when given tradipitant (reduction of 1.4) compared with those given placebo (reduction of 0.4) (p<.0001), as well as an increase in nausea-free days at week 4 (32.3% improvement on tradipitant vs 7.6% on placebo; p=.0003). The average nausea score was 1 or less at week 4 in 32.9% of patients given tradipitant compared with 11.8% of patients given placebo (p=.0013). A greater than 1-point improvement in the gastroparesis cardinal symptom index score was observed in 46.6% of patients given tradipitant compared with 23.5% of patients given placebo (p=.0053). 

    In July 2020, the U.S. Food and Drug Administration (FDA) approved the use of tradipitant for up to 6 months with an option of renewal for an individual patient who requested expanded access.  Since then, other patients who experienced a unique benefit in tradipitant studies have requested expanded access and their applications are currently under review by the FDA. Although this expanded access program is not intended primarily for data collection, Vanda will collect safety data from this cohort of expanded access patients and include this data in its New Drug Application (NDA) for gastroparesis.

    Preclinical and safety data for tradipitant

    A robust package of preclinical work for tradipitant has been completed, including a 2-year carcinogenicity study, depicted in Figure 1.  Figure 1 also includes a summary of the human studies through Phase II. 

    The results from these animal and human studies demonstrate tradipitant's extensive animal and human testing, and well-established safety profile. No significant safety signals were observed in these studies that would be both predictive of clinical safety and would preclude all further clinical development.  In the human studies, tradipitant was well tolerated in individuals who received daily doses of tradipitant ranging from less than 50 mg/day to over 170 mg/day. 

    Vanda believes this entire preclinical package is adequate to support NDA filings for the short-term indications being pursued.  The FDA has communicated, however, that for treating patients beyond 12 weeks, it is requiring Vanda to conduct what it considers to be a standard 9-month non-rodent chronic toxicity study, which currently limits Vanda's ability to collect safety data in humans for more than 12 weeks.

    The FDA-required study design necessitates the sacrifice of dozens of animals and Vanda has disputed the necessity of a 9-month non-rodent chronic toxicity study.  Vanda has taken a public position that unnecessary lethal animal studies should not be conducted, especially in dogs, as such studies are not scientifically justified and would not be consistent with Vanda's scientific and ethical principles, which are shared by many Americans.  Vanda is working with the FDA to resolve this disagreement.

    Despite the disagreement with the FDA, the preclinical package has allowed Vanda to continue to conduct all the efficacy studies necessary for NDA filing.  The lack of long-term (>12 weeks in humans) safety data would likely impact the FDA's willingness to approve tradipitant for a chronic indication.  However, because long-term safety data is not normally a requirement for short-term indications, and with a preclinical profile that has not precluded clinical development, Vanda believes the package is complete for any NDA filing to treat patients for 12 weeks or less.  In gastroparesis, for example, the FDA has communicated to Vanda that it is considering an indication for the short-term relief of nausea in gastroparesis.  While this short-term indication is not preferred, Vanda would consider accepting this limited indication while continuing to pursue a chronic indication.  The chronic treatment of itch in atopic dermatitis would be expected to have a similar issue in review as gastroparesis.

    The indications of motion sickness and the acute respiratory distress (pneumonia) associated with COVID-19 are both short-term indications covering either short-term travel, in the case of motion sickness, or a week to several weeks course of treatment in the case of COVID-19 pneumonia.  At this time, the COVID-19 pneumonia program is recruiting patients in the Phase III ODYSSEY study.  Preparations for the motion sickness study have resumed and the study will commence when local restrictions related to the global COVID-19 pandemic are lifted.  Recruiting in the atopic dermatitis study remains on hold.

    Potential market opportunity for gastroparesis

    Gastroparesis is a severe, significantly underdiagnosed disease with increased morbidity and mortality, representing a significant unmet medical need.  The only FDA approved treatment currently available is metoclopramide, which carries a label restriction of up to 3 months treatment because of increased risk of Parkinson's-like symptoms that can be permanent.  Off label treatments include erythromycin, botulinum toxin injections and gastric stimulators, none of which provide a significant benefit.  Anti-nausea agents, including ondansetron, are also used as needed, although with incomplete relief. 

    As a result of this lack of effective therapeutic options, patients with gastroparesis experience a significant adverse impact on their social and occupational functioning in addition to physical symptoms.  Given the magnitude of improvements seen in the Phase II study, tradipitant has the potential to become the first line option for the treatment of gastroparesis.  As a result of underdiagnosis, it is difficult to estimate with any precision the number of patients that could be treated with tradipitant.  IQVIA reports more than 300,000 monthly metoclopramide prescriptions, the equivalent of 300,000 patients treated with this drug, which is primarily used in the treatment of gastroparesis.  However, the concentrated base of gastroenterology specialists and the development of new and easy to use diagnostics, such as a recently approved breath test that can be performed at home, along with Vanda's significant experience with patient-based marketing and direct-to-consumer awareness campaigns, could represent a large commercial opportunity for Vanda. 

    Potential timeline and estimated milestones for tradipitant in gastroparesis

    • Q3 2020, Expanded Access individual patient program
    • First Half 2021, Enrollment completion of the Phase III study
    • Second Half 2021, NDA submission for tradipitant in gastroparesis
    • Second Half 2022, Commercial launch of tradipitant for the treatment of gastroparesis, if approved

    About Tradipitant

    Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company.  Tradipitant is currently in clinical development for gastroparesis, COVID-19 pneumonia, motion sickness and atopic dermatitis.  The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

    References

    1 Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H., & Polymeropoulos, M. H. (2020). Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Gastroenterology. Advance online publication. https://doi.org/10.1053/j.gastro.2020.07.029

    2 Refer to Company press release titled "Vanda Pharmaceuticals' Interim Analysis from ODYSSEY Study Shows Tradipitant may Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia" issued on August 18, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14256/pdf

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to statements regarding the completion of Vanda's Phase III study of tradipitant for the treatment of gastroparesis, the potential commercial opportunity for tradipitant, the ability of tradipitant to be a first line treatment option for patients with gastroparesis, the adequacy of Vanda's safety data and Vanda's pursuit of both long-term and short-term indications for gastroparesis, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions 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 complete enrollment for its Phase III study of tradipitant for the treatment of gastroparesis, Vanda's ability to complete the clinical development of, submit NDAs for and obtain regulatory approval of tradipitant in the treatment of gastroparesis, motion sickness and atopic dermatitis, Vanda's ability to resolve its disagreement with the FDA regarding the conduct of a 9-month non-rodent chronic toxicity study, and the FDA's assessment of the adequacy of Vanda's safety and efficacy data. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-provides-update-on-tradipitant-development-program-301121338.html

    SOURCE Vanda Pharmaceuticals Inc.

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  17. WASHINGTON, Aug. 18, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today reported that interim analysis showed tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study.

    • Interim analysis of the ODYSSEY study showed that a 14 day tradipitant treatment accelerated clinical improvement by day 7 (HR=2.55, p=0.0375)
    • Tradipitant numerically improved median time to clinical improvement by day 28 (HR=1.55, p=0.2254)
    • Similar overall rates of improvement and mortality were observed for the two treatment arms at day 28

    The interim analysis of the ODYSSEY study demonstrated that hospitalized patients with COVID-19 pneumonia improved sooner when treated with tradipitant as compared to…

    WASHINGTON, Aug. 18, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today reported that interim analysis showed tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study.

    • Interim analysis of the ODYSSEY study showed that a 14 day tradipitant treatment accelerated clinical improvement by day 7 (HR=2.55, p=0.0375)
    • Tradipitant numerically improved median time to clinical improvement by day 28 (HR=1.55, p=0.2254)
    • Similar overall rates of improvement and mortality were observed for the two treatment arms at day 28

    The interim analysis of the ODYSSEY study demonstrated that hospitalized patients with COVID-19 pneumonia improved sooner when treated with tradipitant as compared to placebo. This finding was based on a preliminary analysis of the first 60 patients enrolled in the ODYSSEY study of tradipitant in COVID-19 pneumonia. ODYSSEY is an ongoing Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor (NK-1R) antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection, which was initiated in April 2020. The study is expected to enroll 300 patients, and as of July 15, 2020, 60 patients had enrolled and completed the study. Because this is the first study of tradipitant for this indication and given the increased rate of mortality seen with COVID-19 pneumonia, an interim analysis was planned to better assess the efficacy and safety of tradipitant in this population of COVID-19 patients.

    In the ODYSSEY study, clinical status was assessed on a 7 point scale ranging from death, to mechanical ventilation, various levels of oxygen requirements, to hospital discharge. Clinical improvement was defined as at least a 2 point improvement in the 7 point ordinal scale.

    • Interim analysis in the first 60 enrolled patients showed that similar percentages of patients improved between the two treatment arms, 57% for tradipitant and 50% for placebo. The mortality rate was also similar between the treatment groups with 14.2% for tradipitant and 16.6% for placebo.
    • In the time to improvement analysis, after 7 days of treatment, patients treated with tradipitant recovered earlier than those receiving placebo, which was statistically significant (HR=2.55, p=0.0375). This benefit was generally consistent among patients of varying degree of severity at baseline. At day 28 of the study, tradipitant showed a numerical benefit over placebo with an earlier median time to recovery (HR=1.55, p=0.2254, median time to improvement 10 days for tradipitant and 28 days for placebo).

    This early analysis suggests that tradipitant may act by accelerating the time to clinical improvement for patients with severe COVID-19 pneumonia. If confirmed, this effect may be of significant clinical benefit for patients as well as for public health by decreasing the amount of resources employed in the treatment of patients with COVID-19 pneumonia. Although preliminary, the interim results from this randomized controlled study of tradipitant in COVID-19 pneumonia are encouraging. A larger sample size would be required to definitively determine whether tradipitant offers a therapeutic benefit in hospitalized patients with COVID-19 pneumonia by accelerating time to clinical improvement. The results from this interim analysis will be submitted for publication in a peer reviewed journal.

    The hypothesized mechanism of action of tradipitant as an anti-inflammatory agent in COVID-19 pneumonia potentially would be complementary to antiviral treatments. Ongoing efforts in the development of COVID-19 therapeutics require coordination and cooperation between parties if they are to result in the discovery of useful therapeutics. Vanda looks forward to collaborating with U.S. government agencies and hospitals across the country to confirm these findings expediently. If these results are confirmed, tradipitant could become part of the standard of care, either alone or in combination with antivirals, for patients with COVID-19 pneumonia. 

    "These results, albeit preliminary, are exciting, offering the promise of a significant contribution in the treatment of COVID-19 and the prospect of making tradipitant part of the standard of care in accelerating recovery for patients with COVID-19 pneumonia," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda.

    Vanda has scaled up the commercial manufacturing of tradipitant and significant supplies are expected to be available in the coming months. As the results today may suggest that tradipitant's effects in accelerating recovery may not be restricted to just COVID-19 pneumonia, Vanda also plans to evaluate a clinical program to assess the efficacy of tradipitant in the treatment of seasonal influenza pneumonia.

    Table 1.  Baseline Demographic Summary. Intention-to-Treat Population

























    Characteristic

    Tradipitant 



    Placebo



    Total

     Statistic

    (N= 28)



    (N= 30) 



    (N= 58)

























    Age (years)

    71.0 (62.5 - 77.5)



    66.5 (58.0 - 72.0)



    68.5 (61.0 - 77.0)













    Sex, n (%)











     Male

    20 ( 71.4)



    20 ( 66.7)



    40 ( 69.0)

     Female

    8 ( 28.6)



    10 ( 33.3)



    18 ( 31.0)













    Any Comorbidities, n (%)

    27 ( 96.4)



    28 ( 93.3)



    55 ( 94.8)

     Hypertension

    11 ( 39.3)



    15 ( 50.0)



    26 ( 44.8)

     Diabetes

    8 ( 28.6)



    7 ( 23.3)



    15 ( 25.9)

     Coronary Heart Disease

    1 (  3.6)



    4 ( 13.3)



    5 (  8.6)

     Asthma

    1 (  3.6)



    4 ( 13.3)



    5 (  8.6)













    7 Point Ordinal Scale at Baseline, n (%)











     2 - Hospitalized on mechanical ventilation or ECMO

    4 ( 14.3)



    2 (  6.7)



    6 ( 10.3)

     3 - Hospitalized on non-invasive ventilation or high-flow oxygen supplement

    13 ( 46.4)



    12 ( 40.0)



    25 ( 43.1)

     4 - Hospitalized requiring supplemental oxygen

    9 ( 32.1)



    16 ( 53.3)



    25 ( 43.1)

     5 - Hospitalized not requiring supplemental oxygen, requiring continued medical care

    2 (  7.1)



    0 (  0.0)



    2 (  3.4)













    Time from Hospitalization to Starting Study Treatment, Days 

    4.0 (2.0 - 6.5)



    6.0 (2.0 - 12.0)



    4.0 (2.0 - 9.0)

     Early (<=10 Days from Hospitalization)

    23 ( 82.1)



    22 ( 73.3)



    45 ( 77.6)

     Late (>10 Days from Hospitalization)

    5 ( 17.9)



    8 ( 26.7)



    13 ( 22.4)













    Highest Oxygen Therapy Support , n (%)











     Room Air

    1 (  3.6)



    0 (  0.0)



    1 (  1.7)

     Nasal Cannula (NC)

    5 ( 17.9)



    6 ( 20.0)



    11 ( 19.0)

     Non Rebreather (NRB)

    1 (  3.6)



    2 (  6.7)



    3 (  5.2)

     High Flow Nasal Cannula (HFNC)

    6 ( 21.4)



    9 ( 30.0)



    15 ( 25.9)

     CPAP Mask

    0 (  0.0)



    2 (  6.7)



    2 (  3.4)

     BiPAP Mask

    1 (  3.6)



    1 (  3.3)



    2 (  3.4)

     Mechanical Ventilation

    14 ( 50.0)



    10 ( 33.3)



    24 ( 41.4)





    % = 100 x n/N. Data are median (IQR).



     

    Table 2.  Outcomes Overall and According to Score on the Ordinal Scale at Day 7. Intention-to-Treat Population







     Overall*









    Ordinal Score at Baseline*























    4







    3







    2



    Tradipitant



    Placebo



    Tradipitant



    Placebo



    Tradipitant



    Placebo



    Tradipitant



    Placebo



    (N= 28)



    (N= 30)



    (N=  9)



    (N= 16)



    (N= 13)



    (N= 12)



    (N=  4)



    (N=  2)





    Responder as Improvement of 2 or More Points





















       No. of responders

    13



    7



    6



    6



    2



    1



    3



    0

       Median time to responder

    . (4-NE)



    . (NE-NE)



    4 (3-NE)



    . (4-NE)



    . (5-NE)



    . (NE-NE)



    4 (2-NE)



    . (NE-NE)

         (95% CI) — days































       Hazard ratio (95% CI)**

    2.55 (1.02-6.42 [0.0461])



     2.23 (0.71-6.98 [0.1673])



    2.19 (0.20-24.18 [0.5225])



    NE (0.00-NE [0.9983])

































    Mortality































       Hazard ratio (95% CI)†

    2.65 (0.24-29.29 [0.4255])



     3.14 (0.20-50.23 [0.4186])



    . (NE - NE [NE])



    NE (0.00-NE [0.9985])

       No. of deaths by day 7

    2



    1



    1



    1



    0



    0



    1



    0

       KM estimate — %

    9.8



    3.8



    25.0



    8.3



    0.0



    0.0



    25.0



    0.0

         (95% CI)

    (2.5-33.8)



    (0.6-24.3)



    (3.9-87.2)



    (1.2-46.1)



    (0.0-0.0)



    (0.0-0.0)



    (3.9-87.2)



    (0.0-0.0)

































    Ordinal Score at Day 7 Days — no. (%)‡





















      Patients with baseline

    28



    30



    9



    16



    13



    12



    4



    2

      and day 7 score data































    1

    2 (7.1)



    1 (3.3)



    1 (11.1)



    1 (6.3)



    0 (0.0)



    0 (0.0)



    1 (25.0)



    0 (0.0)

    2

    9 (32.1)



    8 (26.7)



    0 (0.0)



    2 (12.5)



    8 (61.5)



    4 (33.3)



    1 (25.0)



    2 (100.0)

    3

    4 (14.3)



    5 (16.7)



    1 (11.1)



    1 (6.3)



    3 (23.1)



    4 (33.3)



    0 (0.0)



    0 (0.0)

    4

    2 (7.1)



    9 (30.0)



    1 (11.1)



    6 (37.5)



    0 (0.0)



    3 (25.0)



    1 (25.0)



    0 (0.0)

    5

    2 (7.1)



    0 (0.0)



    0 (0.0)



    0 (0.0)



    1 (7.7)



    0 (0.0)



    1 (25.0)



    0 (0.0)

    7

    9 (32.1)



    7 (23.3)



    6 (66.7)



    6 (37.5)



    1 (7.7)



    1 (8.3)



    0 (0.0)



    0 (0.0)

      Odds ratio (95% CI)

    1.05 (0.42-2.63 [0.9149])



    0.40 (0.08-2.02 [0.2692])



    2.69 (0.60-12.18 [0.1980])



    0.43 (0.02-11.53 [0.6180])







    *

    P values and confidence intervals have not been adjusted for multiple comparisons. NE denotes not possible to estimate.

    **

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios bigger than 1 indicate a benefit for tradipitant.

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios less than 1 indicate a benefit for tradipitant.

    Odds ratios and P values were calculated with the use of a proportional odds model. Odds ratio values greater than 1 indicate a benefit for tradipitant.

     

    Table 3.  Outcomes Overall and According to Score on the Ordinal Scale at Day 28. Intention-to-Treat Population







    Overall*                                     



    Ordinal Score at Baseline*























    4







    3







    2



    Tradipitant  



    Placebo   



    Tradipitant 



    Placebo   



    Tradipitant 



    Placebo   



    Tradipitant 



    Placebo



    (N= 28)    



    (N= 30)  



    (N=  9) 



    (N= 16)   



    (N= 13)   



    (N= 12)  



    (N=  4)   



    (N=  2)





    Responder as Improvement of 2 or More Points



















       No. of responders       

    16



    15



    7



    11



    4



    4



    3



    0

       Median time to responder

    10 (4-NE)  



    27 (8-NE) 



    4 (3-NE)   



    9 (4-NE)   



    27 (5-NE) 



    . (7-NE)   



    4 (2-NE)   



    . (NE-NE)

           (95% CI) — days































       Hazard ratio (95% CI)** 

    1.55 (0.76-3.14 [0.2267]) 



    1.59 (0.61-4.15 [0.3396]) 



    1.08 (0.27-4.35 [0.9086]) 



    NE (0.00-  [0.9983])

































    Mortality































       Hazard ratio (95% CI)†  

    1.03 (0.28-3.85 [0.9610]) 



    1.24 (0.13-11.99 [0.8543]) 



    0.95 (0.06-15.26 [0.9731])



    1.84 (0.15-22.52 [0.6328])

       No. of deaths by day 28 

    4



    5



    1



    3



    1



    1



    2



    1

       KM estimate — %         

    20.4



    25.9



    25.0



    35.8



    9.1



    11.1



    50.0



    50.0

           (95% CI)              

    (8.2-45.7)  



    (11.5-52.2)



    (3.9-87.2) 



    (12.4-77.5) 



    (1.3-49.2)  



    (1.6-56.7) 



    (15.5-94.2) 



    (9.0-99.4)

































    Ordinal Score at Day 28 Days — no. (%)‡



















      Patients with baseline  

    28



    30



    9



    16



    13



    12



    4



    2

      and day 28 score data































    1

    4 (14.3)



    5 (16.7)



    1 (11.1)



    3 (18.8)



    1 (7.7)



    1 (8.3)



    2 (50.0)



    1 (50.0)

    2

    8 (28.6)



    5 (16.7)



    0 (0.0)



    1 (6.3)



    8 (61.5)



    3 (25.0)



    0 (0.0)



    1 (50.0)

    3

    1 (3.6)



    2 (6.7)



    1 (11.1)



    0 (0.0)



    0 (0.0)



    2 (16.7)



    0 (0.0)



    0 (0.0)

    4

    0 (0.0)



    3 (10.0)



    0 (0.0)



    1 (6.3)



    0 (0.0)



    2 (16.7)



    0 (0.0)



    0 (0.0)

    7

    15 (53.6)



    15 (50.0)



    7 (77.8)



    11 (68.8)



    4 (30.8)



    4 (33.3)



    2 (50.0)



    0 (0.0)

      Odds ratio (95% CI)     

    1.01 (0.38-2.67 [0.9795]) 



    0.62 (0.09-4.02 [0.6119])



    2.21 (0.50-9.71 [0.2941])



    0.43 (0.02-12.22 [0.6242])







    *

    P values and confidence intervals have not been adjusted for multiple comparisons. NE denotes not possible to estimate.

    **

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios bigger than 1 indicate a benefit for tradipitant.

    Hazard ratios was calculated from the Cox model; P values for hazard ratios were calculated with the log-rank test. Hazard ratios less than 1 indicate a benefit for tradipitant.

    Odds ratios and P values were calculated with the use of a proportional odds model. Odds ratio values greater than 1 indicate a benefit for tradipitant.

     

     

    About Tradipitant

    Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, motion sickness and atopic dermatitis. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to statements regarding the potential for tradipitant to be a safe and effective treatment for COVID-19 pneumonia and seasonal influenza pneumonia and Vanda's ability to make tradipitant available to patients for the treatment of COVID-19 pneumonia and seasonal influenza pneumonia are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions 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 fully enroll and complete the ODYSSEY study and Vanda's ability to complete the development of, and obtain regulatory approval for, tradipitant for the treatment of COVID-19 pneumonia and seasonal influenza pneumonia. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

     

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    SOURCE Vanda Pharmaceuticals Inc.

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  18. WASHINGTON, Aug. 5, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2020.

    "We are very proud of the achievements of our team, especially the record commercial performance, even in the face of the challenges presented by the pandemic. We are also very excited with the progress of the HETLIOZ® SMS applications as we get closer to providing a therapeutic solution to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights  

    • Total revenues from HETLIOZ® and Fanapt® were $62.2 million in the second quarter of 2020, a 5% increase compared to $59.1 million in the second quarter…

    WASHINGTON, Aug. 5, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2020.

    "We are very proud of the achievements of our team, especially the record commercial performance, even in the face of the challenges presented by the pandemic. We are also very excited with the progress of the HETLIOZ® SMS applications as we get closer to providing a therapeutic solution to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.

    Key Financial and Corporate Highlights  

    • Total revenues from HETLIOZ® and Fanapt® were $62.2 million in the second quarter of 2020, a 5% increase compared to $59.1 million in the second quarter of 2019.
    • HETLIOZ® net product sales were $41.6 million in the second quarter of 2020, a 10% increase compared to $37.8 million in the second quarter of 2019.
    • Fanapt® net product sales were $20.6 million in the second quarter of 2020, a 3% decrease compared to $21.2 million in the second quarter of 2019.
    • Cash, cash equivalents and marketable securities (Cash) were $339.8 million as of June 30, 2020, representing an increase to Cash of $47.2 million compared to June 30, 2019.
    • Net income was $8.7 million in the second quarter of 2020 compared to net income of $11.5 million in the second quarter of 2019.

    Key Product and Pipeline Highlights

    Products

    Vanda is encouraged by its record commercial performance during the second quarter of 2020. Vanda continues to implement marketing and sales strategies aimed at supporting continued growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the launch of a Fanapt® for schizophrenia direct-to-consumer campaign at the end of the second quarter of 2020.

    Pipeline

    The COVID-19 pandemic has impacted clinical research globally, including Vanda's previously reported clinical trials. The tradipitant gastroparesis and motion sickness programs have resumed, while recruitment for the tradipitant atopic dermatitis program, as well as the HETLIOZ® delayed sleep phase disorder study and Fanapt® bipolar disorder and long acting injectable studies, is currently on hold.

    Tradipitant

    • An Individual Patient Expanded Access protocol (VP-VLY-686-3303) for tradipitant in gastroparesis was approved by the U.S. Food and Drug Administration (FDA) and the patient was enrolled in July 2020. Under this protocol, this patient will receive tradipitant treatment for a period of up to six months, which may be extended upon review by the FDA.
    • The gastroparesis Phase III clinical study (VP-VLY-686-3301) resumed recruitment. Enrollment in this 200-person study is expected to be completed in the first half of 2021 with a New Drug Application (NDA) filing projected for later that year.
    • The protocol for the pivotal Phase III motion sickness study was discussed with the FDA at the end of Phase II meeting, and the FDA agrees with the adequacy of the program design to support an application. Preparations for this study have begun with the boat trip portion of the study expected to commence as soon as local restrictions are lifted.
    • Patient enrollment in the Phase III clinical study (ODYSSEY VLY-686-3501) of tradipitant in COVID-19 Acute Respiratory Distress Syndrome (ARDS) is ongoing and an interim analysis will be conducted to determine next steps.

    HETLIOZ® (tasimelteon)

    • The Smith-Magenis Syndrome (SMS) marketing authorization applications were accepted by the FDA for priority review with a Prescription Drug User Fee Act (PDUFA-VI) target action date of December 1, 2020.1
    • The FDA appeals process related to the sNDA for HETLIOZ® for the treatment of jet lag disorder is ongoing.

    Key Publications

    • The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in the July 2020 issue of Gastroenterology.2
    • The article "Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial" was published in the July 2020 issue of Frontiers in Neurology.3

    GAAP Financial Results

    Net income was $8.7 million in the second quarter of 2020, compared to net income of $11.5 million in the second quarter of 2019. Diluted net income per share was $0.16 in the second quarter of 2020, compared to diluted net income per share of $0.21 in the second quarter of 2019.

    2020 Financial Guidance

    Vanda will continue to assess the impact of the evolving pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance previously communicated by Vanda is shown below. In addition, Vanda provides an update to Year-end 2020 Cash.

    Full Year 2020

    Financial Objectives

     

    Full Year 2020

    Guidance

                           

     

    Total revenues

     

    $240 to $260 million

     

    HETLIOZ® net product sales

     

    $155 to $165 million

     

    Fanapt® net product sales

     

    $85 to $95 million

    Year-end 2020 Cash

     

    Greater than $340 million as compared to prior

    guidance of greater than $320 million

    Conference Call

    Vanda has scheduled a conference call for today, Wednesday, August 5, 2020, at 4:30 PM ET. During the call, Vanda's management will discuss the second quarter 2020 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 49854840.

    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 Refer to Company press release titled "FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome" issued on August 3, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14226/pdf

    2 Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H., & Polymeropoulos, M. H. (2020). Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Gastroenterology. Advance online publication. https://doi.org/10.1053/j.gastro.2020.07.029

    3 Polymeropoulos, C. M., Mohrman, M. A., Keefe, M. S., Brzezynski, J. L., Wang, J., Prokosch, L. S., Polymeropoulos, V. M., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. (2020). Efficacy of tasimelteon (Hetlioz®) in the treatment of jet lag disorder evaluated in an 8-h phase advance model; a multicenter, randomized, double-blind, placebo-controlled trial. Frontiers in Neurology, 11, 611. https://doi.org/10.3389/fneur.2020.00611

    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 Twitter @vandapharma.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this press release, including, but not limited to, the guidance provided under "2020 Financial Guidance" above and statements regarding Vanda's ability to make HETLIOZ® available to patients with SMS, Vanda's marketing and sales strategies, the Individual Patient Expanded Access protocol for tradipitant, recruitment for the gastroparesis, motion sickness and ODYSSEY studies and clinical development and regulatory timelines for tradipitant and HETLIOZ® are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions 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 assumptions regarding its ability to continue to grow its business in the U.S.; Vanda's ability to minimize the disruption caused by, and maintain business continuity during, the global COVID-19 pandemic and related market volatility; the duration and severity of the global COVID-19 pandemic, including prevailing economic conditions and general uncertainties relating thereto that may be unknown and unforeseeable; Vanda's ability to enroll patients in and complete its gastroparesis, motion sickness and ODYSSEY studies; Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis, motion sickness, atopic dermatitis and COVID-19 ARDS; Vanda's ability to successfully resume the clinical programs that are currently on hold and the FDA's ability to complete its review of the HETLIOZ® applications for the treatment of SMS on time and make the determination that HETLIOZ® is safe and effective in the treatment of SMS in adults and children. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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



    Six Months Ended



    June 30

    2020



    June 30

    2019



    June 30

    2020



    June 30

    2019

    Revenues:















    HETLIOZ® net product sales

    $

    41,561





    $

    37,835





    $

    76,897





    $

    66,792



    Fanapt® net product sales

    20,646





    21,225





    43,310





    39,981



    Total revenues

    62,207





    59,060





    120,207





    106,773



    Operating expenses:















    Cost of goods sold excluding amortization

    5,847





    6,368





    11,054





    11,481



    Research and development

    12,903





    10,950





    28,430





    24,228



    Selling, general and administrative

    33,917





    31,468





    70,938





    62,497



    Intangible asset amortization

    369





    379





    739





    759



    Total operating expenses

    53,036





    49,165





    111,161





    98,965



    Income from operations

    9,171





    9,895





    9,046





    7,808



    Other income

    1,918





    1,649





    3,284





    3,134



    Income before income taxes

    11,089





    11,544





    12,330





    10,942



    Provision for income taxes

    2,375





    18





    3,130





    28



    Net income

    $

    8,714





    $

    11,526





    $

    9,200





    $

    10,914





    Net income per share, basic

    $

    0.16





    $

    0.22





    $

    0.17





    $

    0.21



    Net income per share, diluted

    $

    0.16





    $

    0.21





    $

    0.17





    $

    0.20





    Weighted average shares outstanding, basic

    54,501,308





    53,101,499





    54,153,812





    52,928,101



    Weighted average shares outstanding, diluted

    55,081,397





    54,579,982





    54,975,771





    54,932,932



     

     

    VANDA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (unaudited)





    June 30,

    2020



    December 31,

    2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    95,305





    $

    45,072



    Marketable securities

    244,544





    267,057



    Accounts receivable, net

    24,587





    26,367



    Inventory

    1,384





    1,140



    Prepaid expenses and other current assets

    15,041





    14,500



    Total current assets

    380,861





    354,136



    Property and equipment, net

    3,744





    3,864



    Operating lease right-of-use assets

    10,601





    11,180



    Intangible assets, net

    22,298





    23,037



    Deferred tax assets

    85,558





    87,680



    Non-current inventory and other

    3,569





    3,851



    Total assets

    $

    506,631





    $

    483,748





    LIABILITIES AND STOCKHOLDERS' EQUITY

     







    Current liabilities:







    Accounts payable and accrued liabilities

    $

    28,398





    $

    27,590



    Product revenue allowances

    33,194





    31,915



    Total current liabilities

    61,592





    59,505



    Operating lease non-current liabilities

    11,720





    12,455



    Other non-current liabilities

    1,735





    843



    Total liabilities

    75,047





    72,803



    Stockholders' equity:







    Common stock

    55





    54



    Additional paid-in capital

    642,398





    631,307



    Accumulated other comprehensive income

    596





    249



    Accumulated deficit

    (211,465)





    (220,665)



    Total stockholders' equity

    431,584





    410,945



    Total liabilities and stockholders' equity

    $

    506,631





    $

    483,748



     

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2020-financial-results-301106946.html

    SOURCE Vanda Pharmaceuticals Inc.

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  19. WASHINGTON, Aug. 3, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS). The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS). The FDA has set December 1, 2020 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA-VI).

    "The FDA filing of the HETLIOZ® applications for priority review marks a major milestone and brings us closer to providing a critical…

    WASHINGTON, Aug. 3, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's applications for Smith-Magenis Syndrome (SMS). The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS). The FDA has set December 1, 2020 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA-VI).

    "The FDA filing of the HETLIOZ® applications for priority review marks a major milestone and brings us closer to providing a critical therapy to patients with SMS," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. Currently, there are no approved treatments for patients with SMS, a rare orphan disorder affecting approximately 15,000 people in the U.S.

    About Smith-Magenis Syndrome

    Smith-Magenis Syndrome (SMS) is a developmental disorder that is caused by a small deletion of human chromosome 17p 1,2. In more rare cases SMS is caused by a point mutation in the RAI1 gene which resides in the deleted region. SMS is estimated to affect 1/15,000-25,000 births in the U.S.3  SMS is usually not inherited but rather is due to a de-novo deletion. Patients with SMS present with a number of physical, mental and behavioral problems. The most common symptom of SMS is a severe sleep disorder associated with significant disruption in the lives of patients and their families. 

    References:

    1. Williams, S. R., Zies, D., Mullegama, S. V, Grotewiel, M. S., & Elsea, S. H. (2012). Smith-Magenis syndrome results in disruption of CLOCK gene transcription and reveals an integral role for RAI1 in the maintenance of circadian rhythmicity. Am.J Hum.Genet., 90(1537–6605), 941–949.
    2. Gropman, A. L., Duncan, W. C., & Smith, A. C. (2006). Neurologic and developmental features of the Smith-Magenis syndrome (del 17p11.2). Pediatr.Neurol., 34(0887–8994), 337–350. 
    3. Orphanet ORPHA number 819.

    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 Twitter @vandapharma.

    About HETLIOZ®

    HETLIOZ® (tasimelteon) is a melatonin receptor agonist. HETLIOZ® has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency. For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.

    HETLIOZ® IS NOT CURRENTLY APPROVED BY ANY REGULATORY AUTHORITY FOR THE TREATMENT OF SMS.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this release, including, but not limited to statements regarding the target completion date of the FDA's review of the sNDA and NDA for HETLIOZ® and Vanda's ability to make HETLIOZ® available to patients with SMS, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the ability of the FDA to complete its review of the applications on time and make the determination that HETLIOZ® is safe and effective in the treatment of SMS in adults and children. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2019, 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.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

     

    Cision View original content:http://www.prnewswire.com/news-releases/fda-accepts-and-grants-priority-review-of-vandas-applications-for-hetlioz-tasimelteon-in-the-treatment-of-smith-magenis-syndrome-301104479.html

    SOURCE Vanda Pharmaceuticals Inc.

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  20. WASHINGTON, July 29, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the second quarter 2020 on Wednesday, August 5, 2020, after the market closes.

    Vanda will host a conference call at 4:30 PM ET on Wednesday, August 5, 2020, during which management will discuss the second quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 49854840.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary…

    WASHINGTON, July 29, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced it will release results for the second quarter 2020 on Wednesday, August 5, 2020, after the market closes.

    Vanda will host a conference call at 4:30 PM ET on Wednesday, August 5, 2020, during which management will discuss the second quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 49854840.

    The conference call will be broadcast simultaneously and archived on Vanda's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-second-quarter-2020-financial-results-on-august-5-2020-301102555.html

    SOURCE Vanda Pharmaceuticals Inc.

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  21. WASHINGTON, July 13, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) announced today that the U.S. Food and Drug Administration (FDA) has authorized a single patient in an Individual Patient Expanded Access protocol (VP-VLY-686-3303).  This patient had previously participated in a randomized study of tradipitant in gastroparesis for 12 weeks.  The patient and treating physician requested expanded access to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient's gastroparesis symptoms.

    The FDA's Division of Gastroenterology has authorized expanded access to tradipitant for this patient for an additional 6 months under this protocol…

    WASHINGTON, July 13, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) announced today that the U.S. Food and Drug Administration (FDA) has authorized a single patient in an Individual Patient Expanded Access protocol (VP-VLY-686-3303).  This patient had previously participated in a randomized study of tradipitant in gastroparesis for 12 weeks.  The patient and treating physician requested expanded access to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient's gastroparesis symptoms.

    The FDA's Division of Gastroenterology has authorized expanded access to tradipitant for this patient for an additional 6 months under this protocol with the potential to renew upon written request containing additional safety information collected during those 6 months.

    The 12-week randomized placebo-controlled Phase III study of tradipitant in patients with gastroparesis that this patient originally participated in is ongoing.  In December 2018, Vanda reported results of a Phase II study of tradipitant in gastroparesis where tradipitant was shown to be effective at reducing nausea and other cardinal symptoms of gastroparesis and well tolerated.

    About Tradipitant

    Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, motion sickness and atopic dermatitis.  The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration. The partial clinical hold does not apply to the individual-patient protocol described above.

    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 Twitter @vandapharma.

    Corporate Contact:

    AJ Jones II

    Chief Corporate Affairs and Communications Officer

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com 

    Elizabeth Van Every

    Head of Corporate Affairs

    Vanda Pharmaceuticals Inc.

    202-734-3400

    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/fda-grants-authorization-for-individual-patient-expanded-access-protocol-for-the-use-of-tradipitant-for-gastroparesis-301092427.html

    SOURCE Vanda Pharmaceuticals Inc.

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  22. WASHINGTON, May 26, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (NASDAQ:VNDA), announced today that Vanda will hold its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") in a virtual-only format due to public health concerns related to the COVID-19 pandemic and to protect the health and well-being of its stockholders, directors, employees and the public. As previously announced, the 2020 Annual Meeting will be held on June 11, 2020, at 9:00 a.m. Eastern Time.

    Stockholders will not be able to attend the 2020 Annual Meeting in-person at a physical location. However, the virtual 2020 Annual Meeting will provide stockholders of record as of the close of business on April 17, 2020 the ability to vote their shares and submit…

    WASHINGTON, May 26, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (NASDAQ:VNDA), announced today that Vanda will hold its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") in a virtual-only format due to public health concerns related to the COVID-19 pandemic and to protect the health and well-being of its stockholders, directors, employees and the public. As previously announced, the 2020 Annual Meeting will be held on June 11, 2020, at 9:00 a.m. Eastern Time.

    Stockholders will not be able to attend the 2020 Annual Meeting in-person at a physical location. However, the virtual 2020 Annual Meeting will provide stockholders of record as of the close of business on April 17, 2020 the ability to vote their shares and submit questions during the meeting via the virtual meeting interface.

    If you have already submitted a proxy to vote your shares, your shares will be voted at the 2020 Annual Meeting according to your instructions and you do not need to vote your shares at the 2020 Annual Meeting. Stockholders are encouraged to vote in advance of the 2020 Annual Meeting by telephone, through the Internet or by returning the proxy card or voting instruction card previously received with their proxy materials (as described more fully in Vanda's proxy statement made available to stockholders on April 22, 2020 (the "Proxy Statement") and available Vanda's website at www.vandapharma.com and www.proxyvote.com).

    If you are a stockholder of record, to gain access to the virtual Meeting go to www.virtualshareholdermeeting.com/VNDA2020. To be admitted to the 2020 Annual Meeting webcast at the website provided above, you will need the 16-digit control number included on your proxy card or Notice of Internet  Availability of Proxy Materials (the "Notice"). Beneficial owners of shares held in street name will need to follow the instructions provided by the broker, bank or other nominee that holds their shares (as described more fully in the Proxy Statement and available Vanda's website at www.vandapharma.com and www.proxyvote.com). Only one stockholder per 16-digit control number can access the virtual 2020 Annual Meeting at the website set forth above. Vanda encourages stockholders to log-in to this website and access the webcast before the virtual 2020 Annual Meeting start time.

    Below are additional details on how stockholders can participate in the 2020 Annual Meeting:

    • Access the meeting platform beginning at 8:45 a.m. Eastern Time on June 11, 2020.
    • Once admitted, stockholders of record may submit questions or votes during the Meeting by following the instructions that will be available on the meeting website.
    • To attend the meeting, you will need the 16-digit control number located on your proxy card or Notice.

    A complete list of stockholders entitled to vote at the 2020 Annual Meeting will be open to the examination of any stockholder during the meeting by following the instructions on the 2020 Annual Meeting website once they enter the virtual meeting.

    If you encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number (800) 586-1548 (US) or (303) 562-9288 (Outside the US). This number will also be posted on the 2020 Annual Meeting log-in page. Technical support will be available beginning at 8:45 a.m. Eastern Time on June 11, 2020 and will remain available until the meeting has ended.  Digital copies of the Proxy Statement and Vanda's annual report on Form 10-K for the year ended December 31, 2019 are available at www.proxyvote.com. These materials also are available on Vanda's website at www.vandapharma.com.

    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 Vanda's Twitter and LinkedIn.

    CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

    Various statements in this release relating to the 2020 Annual Meeting may be "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors relating to Vanda's ability to complete the virtual 2020 Annual Meeting include, among others, logistical and administrative issues arising with the hosting of a virtual stockholder meeting, imposition of restrictive governmental regulations implemented to address public health concerns, or operational delays or difficulties because of COVID-19 (or uncertainty regarding the same) and other factors described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020, which are on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Vanda's annual report on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

    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 release is provided only as of the date of this 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.

    Corporate Contact:

    AJ Jones II
    Chief Corporate Affairs and Communications Officer
    Vanda Pharmaceuticals Inc.
    202-734-3400
    pr@vandapharma.com

    Elizabeth Van Every
    Head of Corporate Affairs
    Vanda Pharmaceuticals Inc.
    202-734-3400
    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-virtual-2020-stockholder-meeting-301065031.html

    SOURCE Vanda Pharmaceuticals Inc.

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  23. WASHINGTON, May 20, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the Federal District Court in Washington D.C. granted Vanda's motion to dismiss a False Claims Act lawsuit filed against the company.

    On May 19, 2020, Judge Amit P. Mehta granted Vanda's motion to dismiss the lawsuit, concluding that the relator's allegations fail to state a viable claim under the False Claims Act. At the relator's request, the Court will allow an amended complaint in which the relator may attempt to remedy pleading deficiencies. If the relator does replead, Vanda anticipates filing a renewed motion to dismiss. 

    About Vanda Pharmaceuticals Inc.

    Vanda is a leading global biopharmaceutical company focused on the development…

    WASHINGTON, May 20, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the Federal District Court in Washington D.C. granted Vanda's motion to dismiss a False Claims Act lawsuit filed against the company.

    On May 19, 2020, Judge Amit P. Mehta granted Vanda's motion to dismiss the lawsuit, concluding that the relator's allegations fail to state a viable claim under the False Claims Act. At the relator's request, the Court will allow an amended complaint in which the relator may attempt to remedy pleading deficiencies. If the relator does replead, Vanda anticipates filing a renewed motion to dismiss. 

    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 Vanda's Twitter and LinkedIn.

    About the False Claims Act lawsuit

    In early 2017, a former Vanda employee filed a lawsuit alleging violations of the False Claims Act. That action is captioned United States ex rel. Gardner v. Vanda Pharmaceuticals Inc., No. 17-464 (D.D.C.). After a nearly two year investigation, the U.S. Department of Justice announced in January 2019 that it declined to intervene in the lawsuit, following which Vanda moved to dismiss the lawsuit.

    Corporate Contact:
    AJ Jones II
    Chief Corporate Affairs and Communications Officer
    Vanda Pharmaceuticals Inc.
    202-734-3400
    pr@vandapharma.com

    Elizabeth Van Every
    Head of Corporate Affairs
    Vanda Pharmaceuticals Inc.
    202-734-3400
    pr@vandapharma.com

    Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-wins-motion-to-dismiss-false-claims-act-lawsuit-301063123.html

    SOURCE Vanda Pharmaceuticals Inc.

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  24. WASHINGTON, May 20, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today released a letter (below) from Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals, proposing an approach to Clinical Trial Data Sharing in order to facilitate discovery and clinical utility of COVID-19 therapeutics. Vanda is also involved in the development of therapeutic solutions for COVID-19 and currently in Phase III studies with tradipitant for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

    Clinical Trial Data Sharing, COVID-19 and Remdesivir

    Mihael H. Polymeropoulos, M.D.

    The COVID-19 pandemic has created an urgent need for scientific solutions to this deadly virus.  The pandemic…

    WASHINGTON, May 20, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today released a letter (below) from Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals, proposing an approach to Clinical Trial Data Sharing in order to facilitate discovery and clinical utility of COVID-19 therapeutics. Vanda is also involved in the development of therapeutic solutions for COVID-19 and currently in Phase III studies with tradipitant for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

    Clinical Trial Data Sharing, COVID-19 and Remdesivir

    Mihael H. Polymeropoulos, M.D.

    The COVID-19 pandemic has created an urgent need for scientific solutions to this deadly virus.  The pandemic surprised the world with a new strain of coronavirus never encountered before, which, like its predecessor, has the capacity to infect humans with severe and deadly consequences.  While this pandemic has stunned the world's populations, we are more prepared than ever to respond with a rich scientific armamentarium of tools that can be deployed in the war against this new virus resulting from the extraordinary advances in medical discoveries and treatments in the twenty years since the first full sequencing of the human genome.

    While the reaction to the 1918 world epidemic was mostly one of quarantine and restrictions in movement, the world today can do better.  In 1918, the world did not know the identity of the organism that was killing so many, nor did it know what a virus was, as viruses had not yet been discovered.  Now equipped with the knowledge of over a century of research and tremendous advances in science and therapeutics, we stand in front of this challenge well equipped and ready to respond.  In many ways, our response has been similar to the 1918 epidemic, with mitigation measures that include closing of public places and reducing opportunities for contact, while monitoring the curves of new cases and mortality rates.  Vaccines and therapeutics are on the drawing board but how and when they may be of value is uncertain.  The urgency and mobilization of the scientific community across the globe is impressive.  The collective scientific understanding of the workings of the virus, the clinical course of the infection and the therapeutic approaches are mounting on a daily basis. 

    Although this is great news, the pandemic has imposed an extremely demanding pace on the timetable for the pursuit of scientific answers and solutions.  The ability of developing therapeutic solutions does not just depend on the availability of research tools and ideas.  The ideas must leverage scientific tools and then they must be tested.  Testing of potential therapeutics happens in human volunteers that have been infected with the COVID-19 virus.  One of these programs is the development of antivirals that are intended to slow down or block replication of the virus. 

    The U.S. National Institute for Allergy and Infectious Diseases (NIAID) and Gilead Sciences brought forward the testing of one of these antivirals, remdesivir, a nucleoside analog that induces errors in the copying machinery of the virus, thereby slowing down replication.  Remdesivir has been recently studied in two types of programs, a placebo-controlled study and an open label program.  The NIAID remdesivir placebo-controlled study was concluded and topline results were reported on April 29, 2020.  The topline results were communicated during a brief meeting at the White House by the Director of NIAID and advisor to the President, Dr. Anthony Fauci.  The communication was verbal, short, and conveyed that the study had shown that remdesivir reduced hospital stay by 4 days for remdesivir treated patients as compared to placebo, but it did not significantly reduce mortality.  No other data were presented in any other scientific or media forum.  Dr. Fauci acknowledged that his preference would have been to present this data at a scientific meeting but that the situation required a more immediate communication and that the data would be submitted for a peer review publication in the near future.  Two days later, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) approval of remdesivir in treating patients with severe COVID-19 infection.1  The prescribing information presented by the FDA included the same summary information that was reported at the White House two days earlier, but no additional information on the efficacy trial was given.2  Similarly, the FDA in its cover letter suggested that it had reviewed the topline data and based on that deemed it appropriate to issue an EUA. 

    The paucity of information around this critical therapeutic development for COVID-19 is troubling.  The NIH, the FDA and Gilead Sciences could simply provide the raw data from the clinical trials to the public immediately.  Such a concept of sharing of clinical trial data is not new, instead, it is highly encouraged by the scientific community and data sharing disclosures are now required by most scientific journals according to the recommendations of the International Committee of Medical Journal Editors.3  The reason for sharing of clinical data includes allowing the scientific community to independently form their own conclusions from their own analyses, develop new insights from the data, and accelerate discoveries in the field by not having to repeat the same experiments.  In the case of remdesivir and COVID-19, this degree of data sharing is even more urgent given the finite amount of time within which a study can be conducted in the face of a declining number of new cases.  There are a number of questions that could be answered by the existing remdesivir NIAID study that remain unanswered by the complete unavailability of the data.  For example: Is there a subgroup of patients that performed better than others? Is this subgroup of a certain characteristic, such as age, sex, race, genetic makeup, time since infection, severity of disease, viral load, medication, underlying condition?  And there are many others to be answered.

    The FDA has authorized remdesivir for all people with severe COVID-19 infection, but there may not be enough supply for all eligible patients at this time.  How are doctors supposed to choose who should receive it?  The prevailing rationale, which would suggest that it be administered to the most severely ill first, may be misguided and not supported by the data.  What if analysis of the existing data showed that remdesivir works better when given to less severe patients or very early after the infection?  In this example, providing the currently limited supply of remdesivir to severe patients may be wasteful and may deprive patients who could benefit from it instead.  Another reason for sharing the raw data is that there is no other large dataset of patients with COVID-19 infection and thus there is not a good guide how to optimally design any therapeutic programs.  The question of whether viral load is associated with response is also of critical importance.  Imagine a scenario where the drug's effect was dependent not on disease severity but rather on viral load, so that severely ill patients with low viral load respond to the drug, but severely ill patients with high viral load do not.  What if some patients have zero viral load but nonetheless have a severe infection, would they be candidates for treatment?  Even in a more complex scenario, what if patients had no decrease in viral load but the infectivity of the virus post remdesivir treatment was decreased? What is the cause of mortality and how does it differ between remdesivir and placebo?

    Unfortunately, so far there has been little to no discussion about data transparency and data availability for remdesivir.  Dr. Fauci's statement that the results will be submitted for peer review is not enough.  On the face of it, it appears that this is consistent with the well-established approach to validate scientific findings.  During this process, a scientific report is submitted to a journal and the editorial board appoints two or more reviewers to independently critique the paper and advise whether the conclusions are supported by the data presented.  This process is well-intentioned, and has served us well, but in and of itself it is grossly inadequate for the task in hand.  The American public is comforted that expert scientists opine on the validity of a potential treatment but they would likely prefer that the data are also fully and transparently available to the public for inspection and analysis for both verifying and learning. 

    Reliance upon just the ordinary peer review of scientific reports is not sufficient in this case.  Dr. Fauci's suggestion that worries about "leaks" or "ethical concerns" prompted this style of announcement is not an acceptable explanation either.  Most of the American public is not concerned with the reasons that compelled the verbal announcement of the results from a White House office on April 29.  The American public is interested in seeing the data and having the data available for all to examine and learn from.  The speed of the FDA decision in issuing an EUA for remdesivir needs to be commended but the absence of any available detailed information is of great concern.  The EUA was granted based on the information presented to the FDA.  The data which the FDA used to make its decision must become immediately available to the public.  If the FDA deems that it needs more information to grant a full approval, it can request this information in due course.  Until then, the FDA should provide to the public the information that the FDA scientists used to make its decision.

    If the NIAID, the FDA and Gilead Sciences decided to follow this recommendation and share the data, could they do it quickly?  The process that the NIAID scientists used to analyze the available data is as follows:  anonymized patient data are collected throughout the study, they are tabulated as raw data, and then certain parameters are derived.  These data are stored in standard format files which are of two types, the RAW and the DERIVED data files.  These exact files that the NIAID analyzed and which Gilead Sciences filed with the FDA, can be shared with minimal effort and within minutes after the leaders of the NIAID, the FDA and Gilead Sciences decide to share.  In summary, there is no technical hurdle for the immediate release of the underlying remdesivir clinical study data.  Concerns about credit and intellectual property can easily and expediently be addressed without imposing any delay on the release of this data.

    We are experiencing a historic health crisis where success is dependent on a community coming together and overcoming a tremendous challenge to humanity.  Open source sharing of information has always accelerated solutions to problems, and I am confident that it will work here as well.  In the scientific community, open source mentality and data sharing has served humanity well, especially recently with the Human Genome project, where genetic data were made immediately available to the scientific community for the betterment of human health.  This is the time to show that pharmaceutical companies and government agencies put patients first.  If indeed the interest of patients is front and center, which it should be, then the NIAID, Gilead Sciences and the FDA will release ALL data from the remdesivir studies without delay.

    More than ever, the American public is dependent on the competencies of its leaders, in the government and science alike.  Trust in the system is conditional and temporary and is based upon transparency and truthfulness.  The American public will not, and should not, blindly trust the expert.  The American public should not have to wait for a handful of scientists, no matter how brilliant, to review the information and give their approval.  The American public is entitled to unconditional access to all such data so that all people, and not just a few, can judge the course of affairs and make decisions.  In the midst of this difficult moment for humanity, an unconditional data sharing movement may become a silver lining and the rainbow promise past the storm.  The American public, scientists, and non-scientists, bonded by sharing and trust, will overcome this new challenge. Let us remove from the vocabulary of our democracy the "trust me I am an expert" mentality and replace it with "transparency for all."

    References

    1. Hinton D. U.S. Food and Drug Administration letter to Gilead Sciences, Emergency Use Authorization for remdesivir. White Oak, Md.: U.S. Food and Drug Administration, May 2020.