The Covid-19 pandemic derailed and delayed plans for many biotech companies, but D.C.’s Vanda Pharmaceuticals Inc. closed 2020 with record-breaking revenue — a tradition it’s looking to keep up in the year ahead.
The District drugmaker closed the year with $248.2 million in revenue, 9% more than its $227.2 million total the year prior. Its biggest revenue-generator, non-24-hour sleep-wake disorder treatment Hetlioz, accounted for $160.7 million — 12% more than in 2019. And schizophrenia drug Fanapt represented $87.5 million in 2020 revenue, 4% more than in 2019. The company reported $23.3 million in net income for the year and closed December with $367.7 million in cash, cash equivalents and marketable securities.
“2020 was an exceptional year for Vanda and we’re optimistic about the positive momentum we bring into 2021,” Dr. Mihael Polymeropoulos, president and CEO of Vanda, said on a fourth-quarter earnings call Wednesday.
Vanda’s stock climbed after its earnings dropped, reaching a high of $19.25 Thursday morning and trading up nearly 21% to $18.63 per share by early afternoon.
Raising the bar
That’s after a spring slowdown driven by the pandemic, which was followed by “a significant increase in new Hetlioz scripts as the business has recovered and adapted to the new ways of promotion,” Polymeropoulos said on the call.
Vanda (NASDAQ: VNDA) took in $67.7 million in fourth-quarter revenue: Hetlioz was responsible for $44.2 million — a 14% increase from 2019 — in revenue; Fanapt brought in $23.5 million in revenue, up 5% from 2019.
The D.C. biotech expects that to grow this year, after launching a direct-to-consumer TV ad campaign in December, Polymeropoulos said. “We remain optimistic that awareness will lead to new starts that will hopefully translate to an increase in the number of patients on Fanapt during 2021.”
Vanda is aiming to maintain that momentum and reach between $270 million and $300 million in revenue this year, and to close 2021 with more than $400 million in cash.
Its recent regulatory approval will help. In December, the Food and Drug Administration approved Hetlioz as a treatment for nighttime sleep disturbances in Smith-Magenis Syndrome — making it the first treatment for patients with the rare developmental disorder. It affects roughly 15,000 people nationwide and causes intellectual disability, delayed speech, sleep disturbances and behavioral problems.
Vanda is now in the initial stages of its commercial launch and is “encouraged by the early response,” Polymeropoulos said on Wednesday’s call. The company reports that more than 20 SMS patients have prescriptions for Hetlioz and about 100 families are discussing the treatment option with their doctors.
“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,” Polymeropoulos said.
More on deck
Heading deeper into 2021, Vanda is working to finalize clinical programs for Hetlioz in delayed sleep phase disorder, and in insomnia in autism spectrum disorder. And it’s advancing programs involving Fanapt in bipolar disorder and Parkinson’s disease psychosis, and in a long-acting injectable form in schizophrenia.
Vanda is simultaneously moving forward with multiple programs for drug candidate tradipitant. That includes motion sickness, for which its late-stage trial is temporarily paused, and coronavirus patients with pneumonia, for which it’s still recruiting and expects an interim analysis in the first half of this year. If it’s found to be successful, Polymeropoulos said, “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.”
Vanda is also testing tradipitant in a chronic gastrointestinal disease called gastroparesis. That phase 3 clinical trial is about 65% enrolled and on track to complete enrollment in the first half of 2021 and report results later this year. Vanda said it expects to file its new drug application with the FDA after that.
But about a year ago, Vanda lost a lawsuit it had filed with the regulatory agency for imposing a partial clinical hold and requiring the biotech to perform chronic toxicity studies in dogs before conducting human studies longer than 90 days for tradipitant in gastroparesis. Polymeropoulos said Wednesday the company will not be completing that study as it moves toward filing its application.
“Vanda has explained the reasons that we believe this study not to be necessary in this context, and we’re continuing actively to discuss this appeal with the FDA. We believe that regardless of the context of this study, the NDA filing can proceed,” Polymeropoulos said.
“The company believes that the preclinical and clinical package will be complete for substantial review at the time of submission,” he said on the call, “and we believe that the FDA would be amenable point of view to file this application and complete their review.”
