Q1 2022 Vanda Pharmaceuticals Inc Earnings Call
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Ladies and gentlemen, this is the operator today's conference is scheduled to begin momentarily until that time your lines will again be placed on hold.
For your patience.
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Ladies and gentlemen, thank you for standing by and welcome to the quarter, One 2020 to Vanda Pharmaceuticals earnings Conference call. At this time, all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
A question. During this session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero.
I'd now like to turn the call over to your speaker today, Kevin Moran Ventas, Chief Financial Officer, Sir you may begin.
Thank you Margaret.
Good afternoon, and thank you for joining us to discuss <unk> pharmaceuticals first quarter 2022 performance.
Our first quarter 2022 results were released this afternoon and are available on the SEC Edgar system and on our website Www Dot Vanda pharma dot com.
In addition, you are providing live and archived versions of this conference call on our website.
Joining me on today's call is Dr. <unk>, Polymeropoulos, our president Chief Executive Officer, and channel or the board.
Additionally, we have Tim Williams, our general counsel and Gunther <unk>, our senior Vice President of business development and R&D Committee member.
Following my introductory remarks, I'll also update you on our ongoing activities.
He 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 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 2021.
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.
We encourage all investors to read these reports and our other filings.
The information we provide on this call is provided only as of today and we undertake no obligation to update or revise publicly any forward looking statements. We may make on this call I'm kind 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. Mark <unk>.
Thank you very much Kevin and good afternoon, everyone.
Thank you for joining us today to discuss <unk> first quarter 2022 results.
We believe 2022 is going to be an exciting year for the company as we strengthen our commercial efforts and those bands are clinical pipeline.
Turning first to commercial performance.
On head count.
Talented with payers denials, we sighted patients with non 24%. However, we are progressing our efforts with commercial payers and Medicare and Medicaid to support basins and increased reimbursement approval rates.
Since 2021 over 15 states could revise their Medicaid.
Or is it some criteria.
Dominated in the fix and that certainly is coverage on the base of these studies for the treatment of non 24.
At the same time, we see increase in the adoption of coverage for basins with nighttime sleep disturbances in <unk> syndrome or SMS.
We will continue to move this effort forward and are committed to working with all parties to improve coverage for patients.
<unk> for the indication of nighttime sleep disturbances, we're seeing continued interest by patients and caregivers attributed to direct to consumer campaigns.
We increase awareness around <unk> and our ongoing work with advocacy organizations such as prisms.
Other educational initiatives for SMS are underway.
As previously noted many patients with SMS remain undiagnosed and are currently treated preventive neurodevelopmental disorders.
Our genetics work.
Identified that among patients with autism.
Is an increase in prevalence of the IAEA.
One deletions and loss of function mutations.
Is that some patients diagnosed with autism may also have SMS.
We're evaluating opportunities to engage with the autism community and elevate awareness of <unk>. Among this population as well.
On patent exclusivity, particularly as the product is currently covered by a number of patents listed in the Fda's Orange book with expirations through 2035.
January 2020 to Vanda settled et cetera, as patent litigation against the <unk> pharmaceuticals defendant.
2022, the under trial for the consolidated lawsuit against the remaining defendants was held.
A decision is expected from the court by December 2022.
The four patents that remaining there should have expiration dates between 2033 and 2035.
We remain confident in this patent and look forward to the court's decision.
On the clinical pipeline, we have a number of late stage programs underway.
First I would like to offer an update on our most advanced program with the dividend.
In February Vanda reported results of the phase three study of <unk> in Gastroparesis and initial exploratory analysis.
We have now completed a pooled analysis of two studies of the dividend and Gastroparesis consisting of a total of 342 patients and examine relevant clinical endpoints.
We believe these studies adequately well controlled and the result support substantial evidence of efficacy with the dividend.
I refer you to the.
<unk> figures and tables present and they are included in today's press release.
These large meta analysis shows the dividend to be superior to placebo in key clinical parameters, including.
Improvement in those here the primary endpoint parameter.
Percent nausea free days.
The patient global impression scale chains.
The overall benefit score.
The Gastroparesis Cardinal symptom index score.
An open label study of safety portrait in Gastroparesis is ongoing with.
We continue to receive requests from patients interested in gaining access to a dividend through the expanded access program.
Multiple patients in the expanded access program has been taken to a dividend now for more than a year with the longest having been ultra deep some core over 18 months.
Sanjay has now scheduled a pre NDA meeting with the FDA to discuss the planned new drug application submission quarterly dividend in the short term.
We spent of nausea in Gastroparesis and is committed to delivering this much needed treatment for patients.
In addition, the phase III study in the prevention of motion sickness has resumed enrollment and is already over 15% as well.
The prior phase two study with redeploying the motion sickness observed the significantly lower incidence of vomiting in patients treated with the dividend.
Compared to placebo treated patients.
We expect enrollment to be complete by the end of 2022.
Enrollment is also ongoing in the clinical development programs of <unk> for the treatment of delayed sleep phase disorder.
And for symptoms of autism spectrum disorder.
Finally, our phase II clinical study of Fanapt in acute Medicare episodes in patients with bipolar disorder is progressing and is now over 75% enrolled we.
We expect to complete enrollment by the end of 2022.
To conclude we expect 2022 to be a year with significant milestones as we advance the number of clinical programs towards new indications on that note I will turn now the call over to Kevin to discuss the first quarter of 2022 financials Kevin.
Thank you miles.
I'll begin by summarizing our first quarter 2022 financial results.
Revenues for the first quarter of 2022 were $60 2 million, a 4% decrease compared to $62 7 million for the first quarter of 2021.
<unk> net product sales were $37 million for the first quarter of 2022 compared to $39 3 million in the first quarter of 2021.
Consistent with prior years and expectations. The first quarter 2022 U S revenue was impacted by the annual Medicare manufacturer contribution and the annual payer disruption linked to new plan years plan changes and re authorizations, which you've seen in prior years.
Additionally, the first quarter of 2022 reflects the continued and significant increase reimbursement challenges from payers to fill prescriptions for patients with non 24.
Turning to <unk>.
Fanapt net product sales in the first quarter of 2022 or $23 $2 million essentially flat as compared to $23 3 million in the first quarter of 2021.
Snap net product sales in the first quarter of 2022 decreased by 3% as compared to $24 million in the fourth quarter of 2021.
<unk> prescriptions in the first quarter of 2022 as reported by equity exposure decreased by approximately 2% compared to the fourth quarter of 2021.
This decrease is consistent with the performance of Fanapt, we've seen in the first quarter of prior years.
For the first quarter of 2020 to Vanda recorded a net loss of $6 4 million compared to net income of $8 7 million for the first quarter of 2021.
The net loss for the first quarter of 2022 included an income tax benefit of $1 1 million as compared to an income tax provision of $1 8 million for the same period in 2021.
Operating expenses in the first quarter of 2022, or $67 9 million compared to $52 3 million in the first quarter of 2021.
The $15 5 million increase was primarily driven by higher expenses associated with the support of the heaviest franchise legal support related to ongoing litigation awareness DTC campaigns and other corporate expenses as well as higher R&D expenses related to the late stage for in App development program.
Operating expenses in the first quarter of 2022, or $8 5 million higher as compared to $59 4 million in the fourth quarter of 2021.
This increase was primarily attributable to higher expenses associated with support of the heaviest franchise legal support related to ongoing litigation and other corporate expenses.
We ended cash cash equivalents and marketable securities referred to as cash as of March 31, 2022 were $435 2 million, representing an increase of $57 million compared to March 31, 2021, and an increase of $2 4 million compared to December 31 2021.
Vanda expects to achieve the following financial objectives in 2022.
Net product sales from both <unk> and fanapt of between $240 and $280 million.
<unk> net product sales of between $150 and $180 million.
Fanapt net product sales of between 90 and $100 million.
Year end 2022 cash of greater than $440 million.
With that I'll now turn the call back to the house.
Thank you very much Kevin.
At this point, we'll be happy to answer any questions you may have.
As a reminder to ask a question you will need to press star one on your telephone to withdraw. Your question question about key please John Melo the compile the Q&A roster.
There are no questions at this time.
Please continue vanda management for closing remarks.
Yes. Thank you very much and thank you all for joining us.
We'll talk to you in the near future. Thank.
Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you everyone for participating you may now disconnect.
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