On November 2, 2022 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the third quarter ended September 30, 2022 (Press release, Vanda Pharmaceuticals, NOV 2, 2022, View Source [SID1234622836]).

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"We continue to focus on strong commercial execution, the advancement of our clinical pipeline and our upcoming regulatory milestones of the submissions of an NDA for tradipitant in gastroparesis and an sNDA for HETLIOZ in insomnia," said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. "With stable, mature revenue, efficient operations and strong cash on hand, we are well positioned to deliver long-term growth."

Financial Highlights

Third Quarter of 2022

Total net product sales from HETLIOZ and Fanapt were $65.3 million in the third quarter of 2022, a 7% decrease compared to $70.1 million in the third quarter of 2021.
HETLIOZ net product sales were $41.3 million in the third quarter of 2022, a 9% decrease compared to $45.6 million in the third quarter of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24.
Fanapt net product sales were $24.0 million in the third quarter of 2022, a 2% decrease compared to $24.5 million in the third quarter of 2021.
Net income was $3.3 million in the third quarter of 2022 compared to $7.8 million in the third quarter of 2021.
Cash, cash equivalents and marketable securities (Cash) was $454.8 million as of September 30, 2022, representing an increase to Cash of $13.9 million, or 3%, compared to June 30, 2022.
First Nine Months of 2022

Total net product sales from HETLIOZ and Fanapt were $189.9 million in the first nine months of 2022, a 5% decrease compared to $200.7 million in the first nine months of 2021.
HETLIOZ net product sales were $119.6 million in the first nine months of 2022, an 8% decrease compared to $129.5 million in the first nine months of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24.
Fanapt net product sales were $70.3 million in the first nine months of 2022, a 1% decrease compared to $71.2 million in the first nine months of 2021.
Net loss was $0.6 million in the first nine months of 2022 compared to net income of $26.1 million in the first nine months of 2021.
Cash, cash equivalents and marketable securities (Cash) was $454.8 million as of September 30, 2022, representing an increase to Cash of $48.8 million, or 12%, compared to September 30, 2021.
Key Operational Highlights

HETLIOZ (tasimelteon)

Vanda is preparing for the submission of a supplemental New Drug Application (sNDA) for HETLIOZ in the treatment of insomnia. Vanda expects to submit this sNDA to the U.S. Food and Drug Administration (FDA) by the end of 2022.
Tradipitant

Vanda is continuing to conduct an open-label safety study for tradipitant in gastroparesis and continues to receive requests from patients seeking access to tradipitant through the Expanded Access program that has multiple patients who have taken tradipitant for more than a year.
Vanda is preparing for the submission of a New Drug Application (NDA) for tradipitant in the short-term treatment of nausea in gastroparesis. Vanda expects to submit this NDA to the FDA in the first half of 2023.
The Phase III study of tradipitant in the treatment of motion sickness is approximately 40% enrolled. Results are expected by mid-2023.
Fanapt (iloperidone)

Enrollment of the Phase III clinical study of Fanapt in acute manic episodes in patients with bipolar I disorder is fully enrolled. The study is a placebo controlled four-week evaluation of approximately 400 patients at sites in the U.S. and Europe. Results are expected by the end of 2022.
Early-Stage Programs

The Phase II clinical study of a single-dose treatment of VQW-765 to alleviate social/performance anxiety is fully enrolled. Results are expected by the end of 2022.
In September 2022, Vanda and OliPass Corporation (OliPass) announced a research and development agreement to jointly develop a set of antisense oligonucleotide (ASO) molecules based on OliPass’ proprietary modified peptide nucleic acids. Vanda has already identified two ASO targets that have been validated in cell lines that model two disease targets, one rare orphan and the other applicable to a broad set of immuno-oncological conditions.
In October 2022, Vanda announced that the FDA has granted Orphan Drug Designation for VPO-227 (formerly BPO-27) for the treatment of cholera. Vanda expects to submit an Investigational New Drug (IND) application to the FDA for VPO-227 in 2023.
Legal and Regulatory Updates

The decision for the consolidated HETLIOZ patent lawsuit against Abbreviated New Drug Application (ANDA) defendants is expected from the court by the end of 2022.
Vanda’s lawsuit against the Centers for Medicare & Medicaid Services (CMS) is currently pending and challenges a CMS rule that subjects certain of Vanda’s products to enhanced rebates. Vanda believes the rule is unlawful and contrary to the intent of Congress when it passed the Affordable Care Act.
Vanda filed a lawsuit against the FDA on September 13, 2022 demanding that the FDA immediately publish in the Federal Register a notice of opportunity for a hearing on Vanda’s sNDA for HETLIOZ in the treatment of Jet Lag Disorder. The FDA then published the notice in the Federal Register on October 11, 2022. Vanda intends to continue pursuing FDA approval of the sNDA for HETLIOZ in the treatment of Jet Lag Disorder.
GAAP Financial Results

Net income was $3.3 million in the third quarter of 2022 compared to net income of $7.8 million in the third quarter of 2021. Diluted net income per share was $0.06 in the third quarter of 2022 compared to diluted net income per share of $0.14 in the third quarter of 2021.

Net loss was $0.6 million in the first nine months of 2022 compared to net income of $26.1 million in the first nine months of 2021. Diluted net loss per share was $0.01 in the first nine months of 2022 compared to diluted net income per share of $0.46 in the first nine months of 2021.

2022 Financial Guidance

Vanda is updating its 2022 financial guidance and expects to achieve the following financial objectives in 2022:

Conference Call

Vanda has scheduled a conference call for today, Wednesday, November 2, 2022, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 2022 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 5456289. A replay of the call will be available on Wednesday, November 2, 2022, beginning at 8:30 PM ET and will be accessible until Wednesday, November 9, 2022 at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 5456289.

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.