VNDA Vanda Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Tradipitant - ODYSSEY VLY-686-3501
Pneumonia associated with COVID-19
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
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sNDA Filing
sNDA Filing
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Refusal-to-file letter issued by the FDA for sNDA filing - March 13, 2020. sNDA to be refiled.
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Tradipitant
Motion sickness
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Phase 3
Phase 3
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Phase 3 new enrolment on hold due to COVID-19.
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Tradipitant - EPIONE 2
Atopic dermatitis
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Phase 3
Phase 3
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Phase 3 enrolment commenced October 2019. On hold due to COVID-19.
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|
Fanapt
Bipolar Disorder
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Phase 2
Phase 2
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Phase 3 trial on hold due to COVID-19.
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|
HETLIOZ (tasimelteon)
Delayed sleep phase disorder (DSPD)
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Phase 2
Phase 2
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Phase 3 trial on hold due to COVID-19.
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Tradipitant - EPIONE 1
Atopic dermatitis
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Phase 3
Phase 3
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Phase 3 trial did not meet primary endpoint - February 25, 2020.
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HETLIOZ (tasimelteon)
Jet Lag Disorder
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CRL
CRL
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CRL issued August 19, 2019.
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Tradipitant
Gastroparesis
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Phase 3
Phase 3
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Phase 3 trial initiated 2Q 2019.
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Fanapt
Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.
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Approved
Approved
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Approved May 26, 2016.
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HETLIOZ (tasimelteon)
Insomnia
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Approved
Approved
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Approved January 31, 2014.
|
Latest News
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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
[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-virtual-2020-stockholder-meeting-301065031.htmlSOURCE Vanda Pharmaceuticals Inc.
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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
[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-wins-motion-to-dismiss-false-claims-act-lawsuit-301063123.htmlSOURCE Vanda Pharmaceuticals Inc.
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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
- 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. https://www.fda.gov/media/137564/download.
- Fact Sheet for Patients And Parents/Caregivers, Emergency Use Authorization (EUA) of Remdesivir For Coronavirus Disease 2019 (COVID-19). White Oak, Md: U.S. Food and Drug Administration (FDA), May 2020. https://www.fda.gov/media/137565/download.
- Taichman DB, Backus J, Baethge C, et al. Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. Ann Intern Med 2016;164:505-6.
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.
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-ceos-proposal-on-clinical-trial-data-sharing-covid-19-and-remdesivir-301062757.htmlSOURCE Vanda Pharmaceuticals Inc.
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WASHINGTON, May 13, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that following the completion of a Type A Meeting with the U.S. Food and Drug Administration (FDA) on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ® (tasimelteon) for the treatment of Smith-Magenis Syndrome (SMS). As previously disclosed, Vanda received a Refusal to File letter from the FDA on March 12, 2020. The Type A Meeting resolved the outstanding issues regarding the filing of the application. Vanda plans to resubmit as soon as possible, seeking approval of the solid capsule formulation of HETLIOZ® for the treatment of adults with SMS, and the liquid formulation of HETLIOZ ® for the treatment of children with SMS*.
"We are very pleased with the outcome of the Type A Meeting," said Dr. Mihael H. Polymeropoulos, President and CEO of Vanda. "This meeting was a great example of collaboration with the agency and we appreciate FDA's thoughtful work in helping us advance the progress of our application and bring this potentially important treatment closer to use by patients with SMS."
In December 2018, Vanda reported results of the largest placebo controlled study ever conducted in patients with SMS, with HETLIOZ® patients seeing significant improvements in sleep. SMS is a developmental disorder that is frequently caused by a small deletion of human chromosome 17p.1, 2 In some cases, SMS is caused by a point mutation in the RAI1 gene, which resides in the deleted region. SMS is estimated to affect 1 in 15,000-25,000 individuals.3 Patients with SMS present with a number of physical, mental and behavioral issues. The most common symptom of SMS is a severe sleep disorder, which results in significant disruption in the lives of patients and their families.
*Vanda's resubmission will be in the form of a supplemental New Drug Application for the solid capsule formulation of HETLIOZ® for the treatment of adults with SMS (the sNDA) and a New Drug Application for the liquid formulation of HETLIOZ ® for the treatment of children with SMS (the NDA). Originally, Vanda submitted an sNDA covering both formulations, but the FDA requested that Vanda separate that application into an sNDA and an NDA for the different formulations.
References:
1 Williams, SR, Zies, D, Mullegama, SV, Grotewiel, MS, & Elsea, SH. 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. 2012; 90(1537–6605), 941–949.
2 Gropman, AL, Duncan, WC, & Smith, AC. Neurologic and developmental features of the Smith-Magenis syndrome (del 17p11.2). Pediatr Neurol. 2006; 34(0887–8994), 337–350.
3 Greenberg F, Guzzetta V, Montes de Oca-Luna R et al: Molecular analysis of the Smith –Magenis syndrome: a possible contiguous gene syndrome associated with del(17)(p11.2). Am J Hum Genet. 1991; 49:1207 – 1218.
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.
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]CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited to statements regarding Vanda's HETLIOZ® program for the treatment of SMS and plans to resubmit the sNDA and the NDA related to such program, 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 the preparation of and submit the sNDA and the NDA; the FDA's acceptance and review of such filings; Vanda's ability to obtain FDA approval of HETLIOZ® for the treatment of SMS in adults and children; and other factors that are 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.
SOURCE Vanda Pharmaceuticals Inc.
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WASHINGTON, May 6, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2020.
"Our strong financial performance in the first quarter well positions Vanda to continue to innovate and serve our patients, even during this deadly pandemic," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.
Key Financial and Corporate Highlights
- Total revenues from HETLIOZ® and Fanapt® were $58.0 million in the first quarter of 2020, a 22% increase compared to $47.7 million in the first quarter of 2019.
- HETLIOZ® net product sales were $35.3 million in the first quarter of 2020, a 22% increase compared to $29.0 million in the first quarter of 2019.
- Fanapt® net product sales were $22.7 million in the first quarter of 2020, a 21% increase compared to $18.8 million in the first quarter of 2019.
- Cash, cash equivalents and marketable securities (Cash) were $312.3 million as of March 31, 2020, representing an increase to Cash of $44.5 million compared to March 31, 2019.
- Net income was $0.5 million for the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019.
Key Product and Pipeline Highlights
Vanda is working proactively across its business and research units to protect employees and customers, and to maintain business continuity as a result of the COVID-19 pandemic.
Products
Vanda is encouraged by the strong performance of its commercial products during the first quarter of 2020, driving 22% year-over-year growth. Vanda is implementing marketing and sales strategies aimed at overcoming the disruptions caused by the pandemic. Vanda remains committed to continue innovating and bringing value to patients and prescribers, while advancing and strengthening the awareness and use of its products.
Pipeline
The COVID-19 pandemic has impacted clinical research globally, including Vanda's previously reported clinical trials. New recruitment for the tradipitant atopic dermatitis, gastroparesis and motion sickness programs, as well as the HETLIOZ® delayed sleep phase disorder study and Fanapt® bipolar disorder and long acting injectable studies, is currently on hold.
Tradipitant
- The ongoing atopic dermatitis and gastroparesis studies have been adapted in accordance with U.S. Food and Drug Administration (FDA) guidance to protect the health and safety of currently enrolled patients and healthcare providers.
- The results of the recent atopic dermatitis (EPIONE), gastroparesis (VLY686-2301) and motion sickness (Motion Sifnos) studies have all been submitted to peer-review publications.
- See below for details on Vanda's clinical study, ODYSSEY VLY-686-3501, for the treatment of patients with COVID-19 Acute Respiratory Distress Syndrome (ARDS).
HETLIOZ® (tasimelteon)
- Discussions with the FDA are ongoing regarding the supplemental New Drug Applications for HETLIOZ® in the treatments of jet lag disorder and Smith-Magenis Syndrome.
COVID-19 Therapeutic Program
Vanda initiated the following activities aimed at combating COVID-19:
- Vanda announced the initiation of ODYSSEY VLY-686-3501, a Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant for the treatment of patients with COVID-19 ARDS. Results of this study are expected in the third quarter of 2020.
- Vanda also announced the initiation of the CALYPSO genetics study to evaluate the role of human and viral genetic variations in COVID-19 infection and disease severity.
- Vanda and the University of Illinois at Chicago (UIC) announced a research partnership to identify small molecule inhibitors of cathepsin-L, a host enzyme required for viral processing.
GAAP Financial Results
Net income was $0.5 million for the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019. Diluted net income per share was $0.01 in the first quarter of 2020, compared to a diluted net loss per share of $0.01 in the first quarter of 2019.
2020 Financial Guidance
Vanda will continue to assess the impact of the rapidly evolving COVID-19 pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance communicated by Vanda as of February 25, 2020 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 $320 million
Conference Call
Vanda has scheduled a conference call for today, Wednesday, May 6, 2020, at 4:30 PM ET. During the call, Vanda's management will discuss the first 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 2583625. A replay of the call will be available on Wednesday, May 6, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, May 13, 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 2583625.
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.
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.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided under "2020 Financial Guidance" above and statements regarding Vanda's ODYSSEY study, its collaboration with the UIC and its clinical development programs for tradipitant, HETLIOZ® and Fanapt®, 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 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; the ability of Vanda and the UIC to identify small molecule inhibitors of cathepsin-L; Vanda's ability to enroll patients in and complete its ODYSSEY study; a failure of tradipitant to be demonstrably safe and effective in the treatment of COVID-19 ARDS; Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of COVID-19 ARDS, atopic dermatitis, gastroparesis and motion sickness; Vanda's ability to successfully resume the clinical programs that are currently on hold; and other factors that are 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, which is on file with the SEC and available on the SEC's website at www.sec.gov. Additional factors may be described in those sections of Vanda's quarterly report on Form 10-Q for the quarter ended March 31, 2020, to be filed with the SEC in the second quarter of 2020. 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.
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except for share and per share amounts)
(unaudited)
Three Months Ended
March 31
March 31
2020
2019
Revenues:
HETLIOZ®product sales, net
$
35,336
$
28,957
Fanapt®product sales, net
22,664
18,756
Total revenues
58,000
47,713
Operating expenses:
Cost of goods sold excluding amortization
5,207
5,113
Research and development
15,527
13,278
Selling, general and administrative
37,021
31,029
Intangible asset amortization
370
380
Total operating expenses
58,125
49,800
Loss from operations
(125)
(2,087)
Other income
1,366
1,485
Income (loss) before income taxes
1,241
(602)
Provision for income taxes
755
10
Net income (loss)
$
486
$
(612)
Net income (loss) per share, basic
$
0.01
$
(0.01)
Net income (loss) per share, diluted
$
0.01
$
(0.01)
Weighted average shares outstanding, basic
53,806,317
52,752,774
Weighted average shares outstanding, diluted
54,870,146
52,752,774
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
March 31
2020December 31
2019ASSETS
Current assets:
Cash and cash equivalents
$
64,950
$
45,072
Marketable securities
247,376
267,057
Accounts receivable, net
29,272
26,367
Inventory
1,320
1,140
Prepaid expenses and other current assets
17,828
14,500
Total current assets
360,746
354,136
Property and equipment, net
3,877
3,864
Operating lease right-of-use assets
10,875
11,180
Intangible assets, net
22,667
23,037
Deferred tax assets
86,641
87,680
Non-current inventory and other
3,719
3,851
Total assets
$
488,525
$
483,748
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
26,045
$
27,590
Product revenue allowances
33,177
31,915
Total current liabilities
59,222
59,505
Operating lease non-current liabilities
12,139
12,455
Other non-current liabilities
778
843
Total liabilities
72,139
72,803
Stockholders' equity:
Common stock
54
54
Additional paid-in capital
635,730
631,307
Accumulated other comprehensive income
781
249
Accumulated deficit
(220,179)
(220,665)
Total stockholders' equity
416,386
410,945
Total liabilities and stockholders' equity
$
488,525
$
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]
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