- Vanda Pharmaceuticals reported robust revenues of $47.7 million for the third quarter of 2024, marking a significant increase of 23% over the $38.8 million reported in the same quarter of 2023, demonstrating strong demand for its innovative therapy offerings.
- The company’s financial guidance for the Full Year 2024 has been revised, with the midpoint of both revenue and cash projections being raised, reflecting confidence in their product pipeline and market performance.
- The launch of Fanapt® for the treatment of bipolar I disorder saw new patient starts surge by over 90% in Q3 2024 compared to Q3 2023, highlighting the medication’s favorable reception among healthcare providers and patients.
- Vanda anticipates the initiation of a long-acting injectable program for Fanapt® in the fourth quarter of 2024, which is expected to enhance patient compliance and broaden the treatment options available for bipolar disorder.
- The New Drug Application (NDA) for milsaperidone, aimed at treating schizophrenia and bipolar I disorder, is expected to be submitted in early 2025, with a Phase III program for major depressive disorder anticipated to start by the end of 2024, expanding Vanda’s psychiatric product offerings.
- Following its recent acquisition, the commercial launch of PONVORY® for the treatment of multiple sclerosis commenced in Q3 2024, with efforts to educate prescribers and drive patient adoption currently underway.
- Investigational New Drug (IND) applications for PONVORY® targeting psoriasis and ulcerative colitis are expected to be submitted in the fourth quarter of 2024, which will help diversify the therapeutic applications of this important drug.
- Vanda plans to submit an NDA for tradipitant, a drug designed for motion sickness, in the fourth quarter of 2024, capitalizing on positive results from clinical studies demonstrating its efficacy in preventing nausea and vomiting related to motion.
WASHINGTON, Nov. 6, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) has announced compelling financial and operational results for the third quarter ended September 30, 2024, showcasing their growth trajectory.
In a statement, Mihael H. Polymeropoulos, M.D., President, CEO, and Chairman of the Board at Vanda, expressed satisfaction with the promising market response to the recent launch of Fanapt for bipolar I disorder, underscoring the strength of their clinical data and strategic execution. He projected continuous growth, particularly with the commercial debut of PONVORY for multiple sclerosis, which aims to increase both physician awareness and patient outreach. Polymeropoulos emphasized the strategic diversity that Fanapt, milsaperidone, and Fanapt LAI collectively bring to Vanda’s psychiatry portfolio for sustained revenue development over the years ahead.
On the research and development side, Vanda is committed to advancing its New Drug Applications for tradipitant as a motion sickness treatment and milsaperidone’s applications for schizophrenia and bipolar I disorder. Furthermore, IND filings for PONVORY in ulcerative colitis and psoriasis are anticipated to conclude within this quarter.
Financial Highlights
Third Quarter of 2024
- Total net product sales from Vanda’s trio of products—Fanapt®, HETLIOZ®, and PONVORY®—reached $47.7 million during Q3 2024, an impressive 23% surge compared to the previous year’s earnings of $38.8 million.
- Notably, Fanapt® accounted for $23.9 million in net product sales during the third quarter, reflecting a 12% uptick from $21.3 million in Q3 2023.
- HETLIOZ® contributed $17.9 million to net sales during Q3 2024, a slight increase of 2% from $17.5 million the same quarter last year, showing consistent demand for this treatment.
- PONVORY® recorded $5.9 million in net product sales for Q3 2024, down 32% from the second quarter of 2024’s $8.6 million, following its transition from Actelion Pharmaceuticals, which was finalized on December 7, 2023.
- Despite these sales figures, Vanda reported a net loss of $5.3 million for Q3 2024, contrasting with a net income of $0.1 million in the third quarter of 2023, attributed to increased operational expenditures involved in strategic growth initiatives.
- As of September 30, 2024, Vanda’s cash, cash equivalents, and marketable securities totaled $376.3 million, showing an $11.4 million decrease from the $387.7 million recorded at the end of the previous quarter, excluding a pending payment from Janssen expected to contribute to the fourth-quarter results.
Key Operational Highlights
Psychiatry Portfolio
- Vanda has successfully initiated the commercial launch of Fanapt® targeting the acute treatment of bipolar I disorder in adults, benefiting from an expanded sales force and intensive marketing programs that have catalyzed an approximately 90% increase in new patient prescriptions compared to the same quarter last year.
- The company is gearing up for the submission of a New Drug Application (NDA) for milsaperidone, an active metabolite of Fanapt®, focused on schizophrenia and acute bipolar I disorder treatment, which is targeted for early 2025.
- Plans for a Phase III initiative for Fanapt® long-acting injectable (LAI) formulation are on track to commence in the fourth quarter of 2024, enhancing treatment adherence for patients with bipolar disorder.
HETLIOZ® (tasimelteon)
- Vanda is advancing HETLIOZ LQ® for pediatric insomnia, responding to a significant unmet need in treating sleep disturbances among children, which affects an estimated 20-40% of this population.
- The firm continues to advocate for FDA approval of HETLIOZ® for jet lag disorder and insomnia, contesting a previous rejection through litigation in the U.S. Court of Appeals and actively engaging with the FDA regarding its insomnia application.
- Patents for HETLIOZ® are currently being defended against generic manufacturers in court, with a trial set for early 2026.
- Vanda anticipates decisions from the European Medicines Agency regarding its Marketing Authorization Applications for HETLIOZ® by early 2025.
PONVORY® (ponesimod)
- The strategic launch of PONVORY® for relapsing forms of multiple sclerosis took place in Q3 2024, supported by a dedicated specialty sales force equipped with cutting-edge tools to facilitate provider engagement.
- IND applications for PONVORY® in the management of psoriasis and ulcerative colitis are expected to be filed shortly in Q4 2024, potentially expanding the therapeutic reach of this medicine.
Tradipitant
- The FDA declined Vanda’s NDA for tradipitant aimed at treating gastroparesis symptoms in September 2024; however, the company remains committed to pursuing regulatory approval while maintaining an expanded access program currently serving impacted patients.
- A motion sickness NDA for tradipitant is on track for submission in Q4 2024, showcasing data from three successful clinical trials demonstrating its effectiveness at preventing motion-induced nausea.
- Vanda plans to launch a clinical study of tradipitant aimed at preventing vomiting related to GLP-1 analogs (such as semaglutide) in Q4 2024, further exploring its therapeutic applications.
Early-Stage Programs
- Research continues on VSJ-110, targeting dry eye disorder, with promising early results indicating improvement in symptoms as demonstrated in ongoing proof of concept studies.
- VPO-227, a CFTR inhibitor for cholera treatment, has received clearance to advance into Phase I trials in Bangladesh, marking a significant step in addressing this public health challenge.
- The Phase I clinical study for VCA-894A, targeting Charcot-Marie-Tooth disease type 2S, is expected to begin patient enrollment shortly.
- The Phase I study for VTR-297, designed to treat onychomycosis (a nail fungal infection), was initiated in April 2024, with full enrollment underway and results anticipated by year-end.
- VQW-765 is currently in clinical trials addressing acute performance anxiety in social situations, broadening Vanda’s neurological treatment offerings.
GAAP Financial Results
For the third quarter of 2024, Vanda registered a net loss of $5.3 million, a shift from a net income of $0.1 million in the same quarter the prior year, resulting in a diluted net loss per share of $0.09 compared to a break-even share performance in Q3 2023.
In the first nine months of 2024, the net loss reached $14 million, as opposed to a net income of $4.9 million during the same period in 2023, leading to a diluted loss per share of $0.24 versus a gain of $0.09 in the previous year.
2024 Financial Guidance
Vanda is updating its financial roadmap for 2024, announcing more optimistic financial objectives:
Conference Call
Vanda has scheduled a conference call today, Wednesday, November 6, 2024, at 4:30 PM ET. During this call, the management team will delve into third-quarter financial results along with corporate activities. Investors can join the call at 1-800-715-9871 (domestic) or internationally at 1-646-307-1963 and will need the passcode 2555000. A playback of the call will be made available the same evening at 8:30 PM ET and will remain accessible until November 13, 2024, at 11:59 PM ET. The replay can be accessed at 1-800-770-2030 for domestic participants or 1-609-800-9909 for international listeners, using the same passcode.
The conference call will also be streamed live on Vanda’s official website, www.vandapharma.com. Investors are advised to log on to the website at least 15 minutes prior to the call for registration, software downloads, and installation. Additionally, an archived version of the call will be accessible on Vanda’s website for 30 days following the event.
About Vanda Pharmaceuticals Inc.
Vanda is a prominent biopharmaceutical company committed to developing and commercializing innovative therapies aimed at addressing significant unmet medical needs, thereby enhancing patient lives around the globe. For more insights about Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow them on X @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Statements made in this release, including the financial guidance and prospects for product development and regulatory submissions, are considered forward-looking statements subject to risks and uncertainties that could result in actual outcomes differing from expectations. Vanda encourages considerations of various factors detailed in its SEC filings which can be accessed at www.sec.gov.
And 1-646-982-0462 for international participants, using the same passcode.
This financial disclosure provides a comprehensive overview of Vanda Pharmaceuticals’ performance and strategic initiatives for Q3 2024. Key takeaways include a slight increase in net sales due to consistent demand for HETLIOZ and a significant drop in PONVORY’s sales following its transition. The company faces a net loss due to heightened operational costs associated with growth strategies, leading to a revision of their financial guidance for the year.
In terms of operational highlights, Vanda’s focus on launching new products and advancing its pipeline, particularly for psychiatry and neurology, remains strong. They are actively pursuing new approvals and enhancing their offerings while also exploring treatments for additional conditions.
Investors are encouraged to engage in the upcoming conference call for further insights from the management team on the company’s prospects and strategic direction.
