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Vanda Pharmaceuticals Inc (VNDA) Q4 2020 Earnings Call Transcript

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VNDA earnings call for the period ending December 31, 2020.

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Vanda Pharmaceuticals Inc (VNDA 1.83%)
Q4 2020 Earnings Call
Feb 10, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the Q4 2020 Vanda Pharmaceuticals Inc. Earnings Conference Call. [Operator Instructions]

I would now like to turn the conference over to your host, Kevin Moran, Vanda's Chief Financial Officer. Thank you. Please go ahead.

Kevin Moran -- Senior Vice President, Chief Financial Officer and Treasurer

Thank you, Seidi. Good afternoon and thank you for joining us to discuss Vanda Pharmaceuticals fourth quarter and full year 2020 performance. Our fourth quarter and full year 2020 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website.

Joining me on today's call is Dr. Mihael Polymeropoulos, our President and CEO. Following my introductory remarks, Mihael will update on our ongoing activities, I will then comment on our financial results before opening the lines for your questions.

Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, assumptions and uncertainties. These risks are described 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, which are available on the SEC's EDGAR system and on our website.

Additional factors may be set forth in those sections of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, to be filed with the SEC in the first quarter of 2021. We encourage all investors to read these reports and our other SEC filings. The information we provide on this call is provided only as of today, and we undertake no obligations to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events or otherwise, except as required by law.

With that said, I would now like to turn the call over to our CEO, Dr. Mihael Polymeropoulos.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Thank you, Kevin. Good afternoon everyone and thank you very much for joining us. We are pleased with our financial performance as we navigated the pandemic this last year and continued to drive strong growth during the year in line with our original forecast in February of 2020. Full year revenue for both products was $248.2 million, a 9% increase compared to 2019. Despite a slowdown in late spring since then we have seen a significant increase in HETLIOZ scripts as the business has recovered and adapted to the new ways of promotion.

This demand fueled HETLIOZ growth in the fourth quarter and led us with positive momentum into 2021. HETLIOZ fourth quarter revenue was $44.2 million, a sequential growth of 11%. Our forecast for 2021 is HETLIOZ revenue of $180 million to $200 million, a projected year-over-year growth of 12% to 24%. Fanapt revenue in Q4 saw a 5% increase compared to the fourth quarter of 2019. And in December, we launched a direct-to-consumer campaign with national television advertisement. While it is early in the campaign, the lead indicators of website visits and searches saw significant increase as compared to before the initiation of the campaign.

In parallel, awareness for our Fanapt brand is entering the national stage. We remain optimistic that awareness would lead to new starts that will hopefully translate to an increase in the number of patients on Fanapt during 2021. As we announced in December 1 of 2020, the FDA approved oral capsule and liquid formulations of HETLIOZ for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome for adults and children, respectively. HETLIOZ is the first FDA approved medication for patients with SMS.

SMS is a neurodevelopmental disorder caused by a genetic mutation of chromosome 17, which is a microdeletion in 90% of the patients and a point mutation in the RAI gene, which is included in the microdeletion region in 10% of the patients. SMS affects one in 15,000 to 25,000 births, with an estimated U.S. prevalence of approximately 15,000 patients. The most common and most disruptive clinical expression is a sleep disorder that impacts the function of patients and consequently their families. Vanda has been working over the years in collaboration with the patient advocacy organization, PRISMS to develop HETLIOZ for SMS and bring it to patients.

We are continuing our collaboration following the approval and expand our efforts to increase awareness of the disorder and of HETLIOZ to the broader SMS patient population. [Indecipherable] beginning of the commercial launch of the HETLIOZ capsule formulation for adult patients with SMS were encouraged by the early response. Specifically, more than 100 patient families have now been engaged and are at different stages of discussing the treatment option with their physicians. Well, more than 20 have already received prescriptions.

At this time, however, it's difficult to estimate the growth trajectory for the adoption of HETLIOZ by SMS patients as we deploy different strategies to reach and inform the community of approximately 15,000 SMS patients of the therapeutic option that HETLIOZ brings.

I'll turn now to tradipitant, the Phase III study in gastroparesis is ongoing with over 65% enrolled, on track to complete enrollment in the first half and report results later in 2021. As we have previously communicated, we believe that the current Phase III study can be the last efficacy study required for NDA filing. The response to our television ad for the gastroparesis study has been overwhelming with more than 3,000 patients that have shown interest since late December, a testament to the significant unmet need for this disorder.

In collaboration with the FDA, almost all the patients that we have requested expanded access to tradipitant for gastroparesis has now been approved for a period of six months. And the first completer of the six months period has now been approved for a total of 12 months. The estimated prevalence of gastroparesis in the U.S. is over 5 million patients, the majority of whom remain undiagnosed. The only FDA-approved treatment for gastroparesis is metoclopramide approved in 1979 which due to its potential of severe side effects carries a black-box warning and limitations of use of no more than three months.

Based on IQVIA data, there are over 3 million prescriptions for oral metoclopramide annually. Given the highly limited treatment options and the safety and tolerability profile of metoclopramide, we believe that a new therapy could achieve significant market share and can represent a substantial revenue opportunity for Vanda.

Other Phase III tradipitant programs in motion sickness remain on pause until conditions allow us to resume and complete the pivotal Phase III study for this disorder. The Odyssey study of tradipitant in severely ill COVID-19 pneumonia patients is ongoing and continue to recruit patients following the first interim analysis in the summer. As scheduled, interim analysis is expected to be completed in the first half of 2021. If the detailed analysis results are confirmed, the effects of tradipitant may be of significant clinical benefit for patients as well as for public health by decreasing the amount of resources employed in the treatment of patients with COVID-19 pneumonia and improving outcomes.

Clinical programs for HETLIOZ in delayed sleep phase disorder or DSPD and insomnia in autism spectrum disorder are in the process of finalization and begin to recruit patients this year. Clinical development project programs for Fanapt include bipolar disorder, Parkinson's disease psychosis and the long-acting injectable formulation in schizophrenia, all of them are in various stages of preparation and execution. The full week Phase III study of bipolar I disorder include sites in both the United States and Europe. We have received approval for the ex-U.S. countries, including Russia and the Ukraine. With these approvals, we plan to begin randomized patients in the U.S. and Europe shortly.

On Fanapt for Parkinson's disease psychosis, we're planning two studies, a Phase II open label study of two cohorts followed by a larger, randomized, placebo-controlled Phase III study. Both studies will evaluate the efficacy of Fanapt in the treatment of psychosis in Parkinson's disease. 20% to 40% of people with Parkinson's disease are reported to experience varying degrees of psychosis. There are almost 1 million people in the U.S. with Parkinson's disease. With only one approved treatment for Parkinson's disease psychosis and the significant burden that exists the condition has on the patients and the caregivers, this remains an important unmet medical need.

The Phase II cohort of 24 patient open label study has now received approval to proceed by the FDA and is expected to commence this quarter. Our Cystic Fibrosis Transmembrane Conductance Regulator, CFTR, activator VSJ-110 is in development for the treatment of allergic conjunctivitis. The results from this Phase II study are expected in the first half of the year and will help us guide further development of VSJ-110 to treat a variety of ocular inflammatory conditions, including dry eye disorder. For our CFTR inhibitor, BPO-27, we have initiated a study at a leading cholera lab at Harvard University. This study is evaluating the ability of BPO-27 to block cholera mortality using live vibrio strains in mice.

To conclude, 2020 was an exceptional year for Vanda and we are optimistic about the positive momentum we bring into 2021. The approval of HETLIOZ for nighttime sleep disturbances in SMS patients provides an opportunity to continue our innovative and successful approach to identifying and treating patients with orphan disorders. We look forward to the results of our tradipitant gastroparesis study and are expecting NDA filing for this disorder later in the year.

I will now turn the call back to Kevin to discuss our financial results for the year and after that I will be happy to address any questions you may have. Kevin?

Kevin Moran -- Senior Vice President, Chief Financial Officer and Treasurer

Thank you, Mihael. I'll begin by summarizing our full year 2020 financial results before turning to discuss the fourth quarter of 2020. Total revenues for the full year 2020 were $248.2 million, a 9% increase compared to $227.2 million for 2019. HETLIOZ net product sales of $160.7 million were the primary contributor and driver of our 2020 revenues and so 12% growth compared to 2019. The year-over-year growth of the HETLIOZ business was driven by a combination of unit demand and net price favorability. Fanapt net product sales of $87.5 million for the full year 2020 reflects 4% growth compared to 2019.

For the full year 2020 Vanda recorded net income of $23.3 million compared to net income of $115.6 million for 2019. Net income for the full year 2020 included an income tax provision of $8.3 million as compared to an income tax benefit of $86.5 million for 2019. As a reminder, the income tax benefit of $86.5 million reflecting the financial results for the full year 2019 includes the favorable impact of the release of Vanda's deferred tax asset valuation allowance, which occurred in the third quarter of 2019. Vanda's cash, cash equivalents and marketable securities referred to as cash as of December 31, 2020 was $367.7 million representing an increase of $55.6 million compared to December 31, 2019.

Turning now to our quarterly results, total revenues for the fourth quarter of 2020 were $67.7 million, an 11% increase compared to $60.9 million for the fourth quarter of 2019. HETLIOZ net product sales were $44.2 million for the fourth quarter of 2020, a 14% increase compared to $38.6 million in the fourth quarter of 2019. As of December 31, 2020, the specialty pharmacy channel held under 2.5 weeks of inventory on hand as calculated based on trailing demand and reflects an increase in value of $200,000 when compared to September 30, 2020. The specialty pharmacy inventory on hand at the end of the fourth quarter of 2020 was higher when compared to the fourth quarter of 2019. The value of this inventory change was approximately $2.5 million.

Fanapt net product sales were $23.5 million for the fourth quarter of 2020, a 5% increase compared to $22.3 million in the fourth quarter of 2019. As of December 31, 2020 wholesalers had lower inventory on hand calculated based on trailing demand when compared to September 30, 2020. The value of this inventory change was approximately 200,000. The wholesaler inventory on hand at the end of the fourth quarter of 2020 was higher when compared to the fourth quarter of 2019. The value of this inventory change was approximately $500,000.

Fanapt prescriptions in the fourth quarter of 2020, as reported by IQVIA Xponent, decreased by less than 1% compared to the third quarter of 2020. The performance of the Fanapt business during the last three quarters of 2020 was impacted by the pandemic and the related disruption of patient visits with their physicians and restrictions on physical access of our sales force to healthcare providers. Based on IQVIA reported data for 2020, other branded drugs in the atypical antipsychotic class also appear to have negatively impacted by the pandemic.

For the fourth quarter of 2020, Vanda recorded net income of $8.2 million compared to net income of $4.2 million for the fourth quarter of 2019. Net income for the fourth quarter of 2020 included an income tax provision of $2.7 million as compared to an income tax provision of $1.6 million in the same period in 2019.

Operating expenses in the fourth quarter of 2020 were $57.2 million compared to $56.7 million in the fourth quarter of 2019. The $500,000 increase was primarily due to a combination of higher R&D expenses related to our late-stage clinical programs, partially offset by lower legal and corporate expenses. Operating expenses in the fourth quarter of 2020 increased by $4.6 million as compared to $52.6 million in the third quarter of 2020. The increase is primarily due to a combination of higher R&D expenses related to our late-stage clinical programs, higher commercial expenses related to Fanapt marketing efforts, partially offset by lower legal and corporate expenses.

Vanda expects to achieve the following financial objectives in 2021. Net product sales from both HETLIOZ and Fanapt of between $270 million and $300 million; HETLIOZ net product sales of between $180 million and $200 million; Fanapt net product sales of between $90 million and $100 million; year-end 2021 cash of greater than $400 million. Of note, our HETLIOZ net product sales guidance is based on our currently approved FDA indications for non-24 and nighttime sleep disturbances in SMS. We expect first quarter 2021 HETLIOZ revenue to be impacted by the annual Medicare manufacturer contribution and the annual payer disruption linked to new plan years, plan changes and reauthorizations, which we have seen in prior years.

In regards to the launch of HETLIOZ in sleep disturbances in SMS, following the FDA approval on December the 2020, we've engaged with over 100 patients from our SMS registry and they are currently at different stages of discussing treatment options with their physicians. More than 20 patients have already received prescriptions for HETLIOZ and are working through the insurance reimbursement process. We expect the launch of HETLIOZ in SMS to have a progressive impact on our HETLIOZ net product sales through 2021.

We do not anticipate differentiating our HETLIOZ net product sales between non-24 and SMS or providing incremental progress update to this level of detail. We expect both R&D and SG&A operating expenses to rise in 2021 as compared to 2020 spending levels, however, this expectation continues to be highly dependent on developments in the pandemic and the extent to which it continues to impact our R&D and commercial activities. The primary contributors to the expected 2021 growth in spend include R&D activities related to our late-stage clinical programs for tradipitant, Fanapt and HETLIOZ and commercial programs for Fanapt and HETLIOZ. We expect to continue our trend of adding to our cash balance, while advancing our portfolio of investments in support of patients.

I'll now turn the call back to Mihael.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Thank you very much, Kevin. At this time, we'll be happy to answer any questions you may have.

Questions and Answers:

Operator

[Operator Instructions] For our first question, it's from Chris Howerton from Jefferies. Chris, your line is open.

Chris Howerton -- Jefferies -- Analyst

Great. Thank you very much. Congratulations on the quarter and thanks for taking the questions. So, I guess, the first one from me would be on the expanded access program for tradipitant in gastroparesis. I don't know if I missed it or if you didn't say, could you provide some information in terms of how many patients have been rolled over to that program would be the first question.

And then second question would be also on tradipitant in gastroparesis, one of the questions that I've heard from investors is what's the risk of getting a refuse to file letter, even if you basically have at a high level, an agreement with the FDA regarding kind of what the shape of the submission package might look like in the absence of a long-term toxicology study. So, that would be question two.

And then, I guess, question three is with respect to Fanapt in PDP. I find that very intriguing given that I do follow Acadia, so the competitor in this space. And so I guess how is it that you see Fanapt differentiating and certainly with respect to kind of the other atypicals that had been tried in that space? Thanks.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Yeah. Thank you, Chris. I will start off with Expanded Access program. We're not giving a specific number, it's only a few patients and these are patients that all of them had experience with tradipitant either in the randomized portion open label portion of the current study or prior studies. What is remarkable, however, is that the FDA paid a lot of attention as they always do for Expanded Access to each individual patient. They were interviewed, their doctors provided a lot of material and so did the company on behalf of these patients, any information we had on their clinical responses.

And after this very thorough and quite lengthy view, now all patients that had applied for Expanded Access are almost all have so far been approved. And as I said, the initial duration of approval has been for each patients is six months and for one of these patients have completed the six-month portion, now they are extended another six months with the opportunity for approval. So, it is very clear that these patients recognize unique benefit that they can actually [Phonetic] see it for many of the treatment we experienced in the past. And certainly they put together a convincing thesis for the FDA who is appreciating that indeed, tradipitant for these individual patients is the only drug that provides substantial relief of their symptoms.

I want to also to point out that an Expanded Access program is not one that actively the company or any company is advertising. Expanded Access reserved for drugs that are not approved by patients and their physicians are requesting as the last resort. So, with that, again, I underscore this is not an advertised program and that is why it is mostly patients that could come from the clinical studies. Of course, we're collecting longitudinal data for these patients and this data will also be submitted to the FDA as part of the New Drug Application review.

The second question you asked is what is our conviction of the FDA filing or application upon submission. We actually feel very confident that we would be providing a complete package both from the clinical, but also the preclinical information that will allow substantial review. Of course, it is well discussed by the company and known that a discussion with the FDA on the requirement of yet an additional nine-month drug study is ongoing. This study has not been completed, Vanda has explained the reasons that we believe this study not to be necessary in this context.

And we are continuing actively to discuss this appeal with the FDA. We believe that regardless of the conduct of this study, the NDA filing can preceded that means not only we submit by the FDA files and one of the circumstances that the FDA may consider is to limit the duration of treatment to the three-month duration with the clinical trials now are allowed to. But it is our hope and it will make the argument that this would not be necessary and certainly will provide arguments against that and at the right time of the NDA filing additional data and solutions toward that. So, in summary, the company believes that the preclinical and clinical package will be complete for substantial review at the time of submission. And we believe that the FDA would be amenable point of view to file this application and complete their review.

The third part of your question was something that we are also very excited. The Fanapt Parkinson's disease psychosis and as many begin to now and you are right, Acadia has done a lot of good work not only bring a drug to the market for this indication, but also creating awareness among patients and their physicians for Parkinson's disease psychosis which can be devastating in the face of an already debilitating disorder. We believe that Fanapt profile may actually be quite competitive for two reasons. One, Fanapt is a well-established antipsychotic, the trip [Phonetic] psychosis associated with schizophrenia and of course we have experience to treat the patients for over 10 years now.

But also what we known about Fanapt is that it's receptor binding profile and it is clinical profile as a result suggest a very mild effect on extra pyramidal symptoms. These are the Parkinson's like symptoms that many antipsychotics produce as the side effect. And you see with the approved drug, NUPLAZID, of course, they are neutral in creating the Parkinson's disease symptoms, EPS, but it would believe Fanapt can do so as well. And of course, you always need more than one solution for any disorder the exact clinical profile and other competitive advantages or Fanapt will remain to be seen in the clinical program. But we believe we will have a place in the treatment of Parkinson's disease psychosis. We believe the profile with a 10-year experience of tolerability of Fanapt will be very important, and we believe we'll have a very good commercial standing for the treatment of PDP.

Chris Howerton -- Jefferies -- Analyst

Okay. Well, that's very, very helpful. I appreciate the answers, Mihael. And I guess I have other questions, but I'll hop back in the line and see and defer to my colleagues.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Sure, of course. Thanks, Chris.

Operator

For our next question, we have Joel Beatty from Citi. Joel, your line is open.

Joel Beatty -- Citi -- Analyst

Hi. Thanks for taking the questions and congrats on the progress. First questions are on HETLIOZ [Indecipherable], what do you see as the biggest driver for HETLIOZ sales for 2021 and that will impact whether you hit the lower end or higher end of the range. And I guess I'm curious to hear if it will be more related to the resolution of the impact of COVID or more related to ramping up the existing indication or Smith-Magenis. So, that's question one.

And then question two would be, what -- now that you've gotten, a couple of months ago, the approval for Smith-Magenis for HETLIOZ, what is the potential look like for adding on additional indications in future label expansions? Thanks.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Yeah. Thank you very much, Joel. So, first on the components of the revenue forecast of HETLIOZ. As you know, in 2020, we continue to show growth in the use of HETLIOZ in Non-24 patients and remind our audience that we have just entered year seven since launch. And as many people know it is extraordinary to continue to grow revenue and your patient base in any of the indications seven years after launch, which actually is another testament to the number of patients that are potentially under there -- out there untreated.

So, for this year the forecast drives from a continued small growth on the Non-24 patients, but also the addition of SMS patients, of course, toward in the later part of the year. As we identified these patients they meet with their physicians and they go through the slow progress that we have seen with payer responses. So, a component will be the growth in Non-24 and a growing component with trajectory it's hard to fully predict right now is the addition, steady addition of SMS patients but creating the bulk of the annual revenue toward the end of the year.

You asked about additional indications, what we've learned from the Non-24 experience, the SMS experience and also the extensive program that we run in Phase advance related with just like bottom is that HETLIOZ has the significant potential in disorders where there is an aberration of the circadian rhythm. And as I mentioned in the script, we're evaluating now two disorders and work actually is -- the clinical work has already started in one of them that is delayed sleep phase disorder.

As many know this is a more common disorder, which affects a significant percentage of people at the adolescent or early adulthood that still remains a common disorder in -- relatively common disorder in adults. The issue with the DSPD and the core issue is difficulty falling to sleep at a desired time with common expression where patients initiate sleep in the early morning hours. Once you fall asleep, you remain asleep for the duration of time that you need.

So, the potential of HETLIOZ to be a useful agent is high given the technical understanding that HETLIOZ has already shown the ability to phase advance. We have not yet tested delayed sleep phase disorder patients, but this work is starting right now and a clinical observation study, open-label studies ongoing. The second indication that is very interesting is the insomnia in patients with autism. And then, again, well, the mechanism is not very well understood, there is insomnia of -- sleep initiation is one of the most common complaints for patients with autism disorder with about 80% of them reporting it and requiring treatment. There it is believed that the circadian, the regulation may cause this difficulty with sleep latency. So, that's a program that is in the late stages of our protocol design and discussions with the FDA for initiation of clinical work, hopefully in the first half of this year.

Joel Beatty -- Citi -- Analyst

Great. Thanks for those great details. So, if I can finish up by asking two questions about tradipitant, one would be, what do you think you need to show an efficacy for FDA to be agreeable to approval, would it be a kind of standard 0.05 P value on the primary endpoint or is it a higher bar than that given, I think, originally an additional Phase III study was planned, that's no longer planned. And then the second question is regarding the nine month non-rodent animal studies, I know those haven't been completed, but has they been started or is there any way to start those before getting clarity from whether FDA will accept the filing or not or if you're granted to refuse the file with that begin a 9-month study at that time. Thanks.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Yeah, I'll start with the last one. No, we are not conducting these studies now. We've been very clear with the FDA that this is not a study that we'll undertake. And this objection is fundamental that Vanda does not believe in that unnecessary animal studies, especially in dogs should be conducted. And we're not alone thinking that, there is an entire movement of not conducting unnecessary animal studies. And part of this movement is the FDA themselves and they are making a lot of progress, trying to understand alternative technologies that can be used. Those that the FDA understands, the limitations of these studies that may not provide the information that is necessary for safe drugs.

So, I would say, over the last couple of years Vanda has developed a sophistication around the utility of starting other studies as well as alternative studies I will not be discussing today, but studies that Vanda is conducting and will be providing information to the FDA for their review as well.

The other part of your question was about study outcomes and expectations. So, just to remind everybody that we have discussed that Vanda prior to initiation of this Phase III study met with the FDA at the end of Phase III meeting and discussed the protocol design and the program forward. So, we have an agreement with the FDA that this study with the FDA accepted design that we're following and the endpoints that we're studying and the population that includes both idiopathic and diabetic gastroparesis patients will be sufficient if successful as the pivotal registration on the study.

And just a little more detail what the primary endpoint is improvement in the symptom of nausea in patients with gastroparesis while at the same time the scale that measures all symptoms of gastroparesis along with global Impression scale has been characterized. And we're looking this study to refine the design as a 4-week screening leading to a 12-week treatment and we will be looking at the effects of the drug in the latter part of the exposure weeks 11, 12 and also at weeks three and four as we've done in the prior 4-week study. So, we feel very confident that if successful this study will be the only study required.

Joel Beatty -- Citi -- Analyst

Thanks again for all of those helpful details. And maybe just one last point of clarification on the last point, all that sort of -- it sounds like you have a fairly expensive agreement with FDA. But as that -- does that mean a P value of around 0.05 is part of approval?

Mihael H. Polymeropoulos -- President and Chief Executive Officer

That has not been a point of discussion, but FDA guidance determines the thresholds as a statistically significant in a predetermined endpoint is a value of less than 0.05. So, there is no additional discussion on that and we expect that we will be held to the same standard. And just to remind this audience here that Vanda has certainly met and exceeded that statistical significance in the smaller Phase II study with similar endpoints.

Joel Beatty -- Citi -- Analyst

Great. Thank you very much.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Thank you, Joel.

Operator

[Operator Instructions] I am showing no further questions at this time, I would like to turn the conference back to Vanda management for the closing remarks.

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Hi. Thank you, operator, and thank you very much all of you for joining us, and we'll see you in future calls. Looking forward to an exciting here both on the commercial and clinical front. Thank you very much.

Operator

[Operator Closing Remarks]

Duration: 43 minutes

Call participants:

Kevin Moran -- Senior Vice President, Chief Financial Officer and Treasurer

Mihael H. Polymeropoulos -- President and Chief Executive Officer

Chris Howerton -- Jefferies -- Analyst

Joel Beatty -- Citi -- Analyst

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