About Us | ScientistVNDA Vanda Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
Tradipitant
Gastroparesis
|
Phase 3
Phase 3
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Tradipitant - ODYSSEY VLY-686-3501
Pneumonia associated with COVID-19
|
Phase 3
Phase 3
|
Phase 3 data August 18, 2020 noted statistically significant improvement by Day 7. However, improvement was not statistically significant at Day 28. Announced August 3, 2021 that enrollment will be closed due to futility.
|
|
FANAPT (iloperidone)
Bipolar Disorder
|
Phase 3
Phase 3
|
Phase 3 trial currently enrolling patients as of July 2021.
|
|
HETLIOZ (tasimelteon)
Delayed sleep phase disorder (DSPD)
|
Phase 3
Phase 3
|
Phase 3 trial currently enrolling as of July 2021.
|
|
FANAPT (iloperidone)
Maintenance treatment of schizophrenia in adults
|
Approved
Approved
|
Approved May 26, 2016.
|
|
VSJ-110
Allergic Conjunctivitis
|
Phase 2
Phase 2
|
Phase 2 trial planned.
|
|
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
|
Approved
Approved
|
FDA approval announced December 1, 2020.
|
|
Tradipitant - EPIONE 2
Atopic dermatitis
|
Phase 3
Phase 3
|
Phase 3 enrolment commenced October 2019. On hold due to COVID-19.
|
|
Tradipitant
Motion sickness
|
Phase 3
Phase 3
|
Phase 3 new enrolment on hold due to COVID-19.
|
|
Tradipitant - EPIONE 1
Atopic dermatitis
|
Phase 3
Phase 3
|
Phase 3 trial did not meet primary endpoint - February 25, 2020.
|
|
HETLIOZ (tasimelteon)
Jet Lag Disorder
|
CRL
CRL
|
CRL issued August 19, 2019.
|
|
HETLIOZ (tasimelteon)
Insomnia
|
Approved
Approved
|
Approved January 31, 2014.
|
Latest News
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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
- 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
[email protected]Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
[email protected]
View original content:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-closes-enrollment-in-the-odyssey-study-comparing-tradipitant-and-placebo-in-hospitalized-covid-19-pneumonia-patients-301346549.htmlSOURCE Vanda Pharmaceuticals Inc.
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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
- 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
2021June 30
2020June 30
2021June 30
2020Revenues:
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
2021December 31
2020ASSETS
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
[email protected]Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
[email protected]
View original content:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2021-financial-results-301343567.htmlSOURCE Vanda Pharmaceuticals Inc.
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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) 363-7171W. Scott Holleman
Garam Choe
BRAGAR EAGEL & SQUIRE, P.C.
810 Seventh Avenue, Suite 620
New York, NY 10019
Fax: (212) 486-0462
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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
[email protected]Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
[email protected]
View original content:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-to-announce-second-quarter-2021-financial-results-on-july-28-2021-301338914.htmlSOURCE Vanda Pharmaceuticals Inc.
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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
[email protected]Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
(202) 734-3400
[email protected]
View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-participation-at-upcoming-2021-investor-conferences-301290225.htmlSOURCE Vanda Pharmaceuticals Inc.