On November 3, 2021 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the third quarter ended September 30, 2021 (Press release, Vanda Pharmaceuticals, NOV 3, 2021, View Source [SID1234594279]).

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"Vanda is approaching another pivotal moment in its 18-year history with the upcoming completion of the Phase III study of tradipitant in gastroparesis and anticipated results by the end of this year. We believe that tradipitant has the potential to become the first new product in 40 years for the treatment of gastroparesis, a serious and debilitating disorder that severely impacts the lives of many people. Additionally, the launch of HETLIOZ and HETLIOZ LQ for nighttime sleep disturbances in people with Smith-Magenis Syndrome is progressing well as we are beginning our broad awareness campaign. Across all of our programs, patient access to innovative treatments remains a key goal of Vanda. We are currently working to address the escalating reimbursement delays for HETLIOZ, which are especially impacting Non-24 patients with light perception, and we are confident in our ability to drive positive outcomes for patients. I am proud of the Vanda team for continuing to advance Vanda’s innovation objectives and creating value for patients and all of the company’s stakeholders," said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board.

Financial Highlights

Third Quarter of 2021

Total net product sales from HETLIOZ and Fanapt were $70.1 million in the third quarter of 2021, a 16% increase compared to $60.3 million in the third quarter of 2020.
HETLIOZ net product sales were $45.6 million in the third quarter of 2021, a 15% increase compared to $39.6 million in the third quarter of 2020.
Fanapt net product sales were $24.5 million in the third quarter of 2021, an 18% increase compared to $20.7 million in the third quarter of 2020.
Income before taxes was $10.7 million in the third quarter of 2021 compared to $8.4 million in the third quarter of 2020.
First Nine Months of 2021

Total net product sales from HETLIOZ and Fanapt were $200.7 million in the first nine months of 2021, an 11% increase compared to $180.5 million in the first nine months of 2020.
HETLIOZ net product sales were $129.5 million in the first nine months of 2021, an 11% increase compared to $116.5 million in the first nine months of 2020.
Fanapt net product sales were $71.2 million in the first nine months of 2021, an 11% increase compared to $64.0 million in the first nine months of 2020.
Income before taxes was $33.8 million in the first nine months of 2021 compared to $20.7 million in the first nine months of 2020.
Cash, cash equivalents and marketable securities (Cash) was $406.0 million as of September 30, 2021, representing an increase to Cash of $57.4 million compared to September 30, 2020.

Key Operational Highlights

Tradipitant

Enrollment of the randomized portion of the Phase III clinical study of tradipitant in gastroparesis is complete. The randomized portion of the study is a 12-week study of approximately 200 patients with idiopathic or diabetic gastroparesis. Results are expected by the end of 2021. Enrollment of the open label portion of the study is ongoing with more than 250 patients enrolled.
HETLIOZ (tasimelteon)

Reimbursement challenges with HETLIOZ prescriptions for patients with Non-24 have increased significantly. While Vanda is working to address these challenges and is confident in its ability to successfully navigate the current environment, Vanda is revising its HETLIOZ net product sales guidance to $170 to $190 million from the prior HETLIOZ net product sales guidance of $180 to $200 million.
In December 2020, the FDA approved HETLIOZ capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).1 To date, more than 90 patients with SMS have been prescribed HETLIOZ or HETLIOZ LQ and a broad awareness campaign is expected to begin during the fourth quarter of 2021.
A Phase III clinical study of HETLIOZ in delayed sleep phase disorder (DSPD) is currently enrolling patients. The study has a 28-day randomized evaluation period and plans to enroll approximately 300 patients. DSPD is likely the most prevalent circadian-rhythm sleep disorder, affecting approximately 1% of the population, and there is no FDA approved treatment at this time.2
Fanapt (iloperidone)

A Phase III clinical study of Fanapt in acute bipolar mania disorder is currently enrolling. The study is a placebo controlled four-week evaluation of approximately 400 patients at sites in the U.S. and Europe.
A repeat-dose clinical pharmacology study of the long acting injectable (LAI) formulation of Fanapt is ongoing. A Phase III study of the LAI formulation for the treatment of acute schizophrenia is planned to follow the pharmacology study.
Evaluation of P88, the active metabolite of iloperidone, has been initiated. P88 has the potential to improve the clinical profile of Fanapt and create sustained, long-term value in the treatment of psychiatric disorders.
GAAP Financial Results

Income before taxes was $10.7 million in the third quarter of 2021 compared to $8.4 million in the third quarter of 2020. Net income was $7.8 million in the third quarter of 2021 compared to net income of $5.9 million in the third quarter of 2020. Diluted net income per share was $0.14 in the third quarter of 2021 compared to diluted net income per share of $0.11 in the third quarter of 2020.

Income before taxes was $33.8 million in the first nine months of 2021 compared to $20.7 million in the first nine months of 2020. Net income was $26.1 million in the first nine months of 2021 compared to net income of $15.1 million in the first nine months of 2020. Diluted net income per share was $0.46 in the first nine months of 2021 compared to diluted net income per share of $0.28 in the first nine months of 2020.

2021 Financial Guidance

Vanda is updating its 2021 financial guidance and expects to achieve the following financial objectives in 2021:

Conference Call

Vanda has scheduled a conference call for today, Wednesday, November 3, 2021, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5961858. A replay of the call will be available on Wednesday, November 3, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, November 10, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5961858.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

References

Refer to Company press release titled "FDA Approves HETLIOZ (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome" issued on December 1, 2020. View Source
P.J. Murphy, Delayed Sleep-Phase Type, Encyclopedia of Sleep, Academic Press, 2013, Pages 22-25, ISBN 9780123786111, View Source