VNDA Vanda Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Tradipitant
Gastroparesis
|
Phase 3
Phase 3
|
Phase 3 enrollment to be completed 1H 2021.
|
|
VSJ-110
Allergic Conjunctivitis
|
Phase 2
Phase 2
|
Phase 2 trial planned.
|
|
Fanapt
Maintenance treatment of schizophrenia in adults
|
Approved
Approved
|
Approved May 26, 2016.
|
|
HETLIOZ (tasimelteon)
Delayed sleep phase disorder (DSPD)
|
Phase 2
Phase 2
|
Phase 3 trial to be initiated 1Q 2021.
|
|
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 - 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.
|
|
Tradipitant
Motion sickness
|
Phase 3
Phase 3
|
Phase 3 new enrolment on hold due to COVID-19.
|
|
Fanapt
Bipolar Disorder
|
Phase 2
Phase 2
|
Phase 3 trial 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
-
View Full Article Hide Full Article
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
- 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
- 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
2020December 31
2019December 31
2020December 31
2019Revenues:
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
2020December 31
2019ASSETS
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
[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-reports-fourth-quarter-and-full-year-2020-financial-results-301226341.htmlSOURCE Vanda Pharmaceuticals Inc.
-
View Full Article Hide Full Article
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
[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-to-announce-fourth-quarter-and-full-year-2020-financial-results-on-february-10-2021-301220624.htmlSOURCE Vanda Pharmaceuticals Inc.
-
View Full Article Hide Full Article
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:
- 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.
- 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.
- 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
[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/fda-approves-hetlioz-tasimelteon-for-the-treatment-of-nighttime-sleep-disturbances-in-smith-magenis-syndrome-301183162.htmlSOURCE Vanda Pharmaceuticals Inc.
-
View Full Article Hide Full Article
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
- 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
- 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
- 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
- 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
[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-reports-third-quarter-2020-financial-results-301162148.htmlSOURCE Vanda Pharmaceuticals Inc.
-
View Full Article Hide Full Article
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
- 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
- Pedram, H., Reza, D. (2019, September). Vernal keratoconjunctivitis. UpToDate. https://www.uptodate.com/contents/vernal-keratoconjunctivitis.
- 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
[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-receives-fda-approval-to-proceed-with-investigational-new-drug-vsj-110-for-allergic-conjunctivitis-301159858.htmlSOURCE Vanda Pharmaceuticals Inc.