Vanda Pharmaceuticals Reports First Quarter 2024 Financial Results
Vanda Pharmaceuticals reported their first quarter 2024 financial results with revenues of $47.5 million, a 5% increase from the previous quarter. The company achieved various milestones, including FDA approval for Fanapt® in bipolar I disorder, with commercial launch expected in Q3 2024. Additionally, they anticipate submitting the NDA for Milsaperidone in schizophrenia and bipolar disorder in early 2025. Vanda also expects to launch PONVORY® for multiple sclerosis in Q3 2024 and has ongoing clinical trials for Tradipitant for various conditions. Financially, total net product sales decreased by 24% compared to the first quarter of 2023. Net loss was $4.1 million, and cash reserves increased to $394.1 million. Despite challenges, Vanda remains optimistic about future growth.
Vanda achieved FDA approval for Fanapt® in bipolar I disorder, expanding their addressable patient population. They expect to submit the NDA for Milsaperidone in early-2025, potentially extending exclusivity into the 2040s. The launch of PONVORY® for multiple sclerosis in Q3 2024 and ongoing clinical trials for Tradipitant demonstrate significant progress in their pipeline. Vanda's focus on commercializing treatments for unmet medical needs and expanding their product portfolio shows promise for future growth.
Total net product sales decreased by 24% compared to the first quarter of 2023, with a net loss of $4.1 million in Q1 2024. While cash reserves increased to $394.1 million, challenges in the U.S. market due to generic competition impacted financial performance. Uncertainties surrounding HETLIOZ® and upcoming commercial launches hindered Vanda's ability to provide financial guidance for 2024. The company faces patent litigation challenges and competitive pressures in the market.
Insights
Vanda Pharmaceuticals' first quarter financial results reflect a mixed performance, with a modest revenue uptick from the prior quarter but a significant year-over-year decline. This requires a closer examination of the underlying causes. While the quarterly revenue increase suggests a positive trajectory, the sharp annual decrease raises concerns about the company's market position and competitive dynamics, especially considering the reported 49% decrease in HETLIOZ® net product sales due to generic competition.
The cash position appears robust, providing a cushion for future investments and operational flexibility. However, the net loss reported indicates that profitability challenges persist. The anticipated commercial launches and new FDA approvals may offer growth potential, but these developments also come with execution risks and require substantial investment in marketing and sales force expansion. Investors should monitor the effectiveness of these commercial strategies and the impact of generic competition on the company's flagship products.
The pharmaceutical landscape is heavily influenced by patent cliffs and the introduction of generics, as evidenced by the decline in HETLIOZ® sales. Yet, Vanda's pipeline, including tradipitant for gastroparesis and new indications for Fanapt®, suggests potential for growth. The approval of Fanapt® for acute bipolar I disorder and the strategic focus on a long-acting injectable version could bolster its standing in the psychiatry market.
In the long run, Vanda's investment in early-stage programs and expansion into additional indications like psoriasis could diversify revenue streams. However, these initiatives also expose the company to regulatory and developmental risks. The mixed financial results paired with upcoming PDUFA dates and NDA submissions make it a critical period for the company, where successful product launches and regulatory outcomes can significantly shift investor sentiment.
Patent exclusivity is a pivotal driver of pharmaceutical companies' valuations. Vanda's efforts to extend the patent life of their products, such as Fanapt® and their LAI formulation, suggest a strategic use of IP to protect revenue streams. The mentions of pending patent applications that could extend exclusivity into the 2040s are promising for long-term investors looking for sustainability in Vanda's market exclusivity.
However, the recent Supreme Court denial to review the patent litigation decision against Teva and Apotex, which held certain HETLIOZ® claims invalid, is a setback. This underlines the volatility and unpredictability inherent in reliance on patent protections in the biotech sector. Investors should consider the potential impact of such litigation outcomes on the company's market exclusivity and financial health.
- Revenues for Q1 2024 were
$47.5 million 5% compared to Q4 2023 - Cash increase of
$5.9 million $394.1 million - Fanapt® approved for the acute treatment of bipolar I disorder; commercial launch expected in Q3 2024
- Milsaperidone NDA for schizophrenia and bipolar disorder expected to be submitted in early-2025
- PONVORY® commercial launch expected in Q3 2024
- Tradipitant NDA review for gastroparesis ongoing, PDUFA date of September 18, 2024
- Tradipitant second Phase III motion sickness study results expected in Q2 2024; NDA expected to be submitted in Q4 2024
"We are very proud of our accomplishments in the first quarter of 2024, which were achieved with a small but efficient organization that is enthusiastic to continue developing and commercializing treatments for people who need them," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We expect several significant milestones in the coming months, including the launch of Fanapt in acute bipolar I disorder, the launch of Ponvory in multiple sclerosis, the potential approval of tradipitant in gastroparesis, the phase III results of tradipitant in motion sickness, the upcoming NDA filings of milsaperidone in psychiatric disorders and of tradipitant in motion sickness and the initiation of clinical programs in depression, psoriasis, ulcerative colitis and pediatric insomnia. We are confident that our robust revenue, strong cash position and efficient operations position us well for significant growth and value creation in the years to come."
Financial Highlights
- Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were
$47.5 million 24% decrease compared to$62.5 million 5% increase compared to$45.3 million - Fanapt® net product sales were
$20.6 million 10% decrease compared to$22.9 million 9% decrease compared to$22.6 million - HETLIOZ® net product sales were
$20.1 million 49% decrease compared to$39.6 million 5% decrease compared to$21.1 million U.S. - PONVORY® net product sales were
$6.8 million - Net loss was
$4.1 million $3.3 million $2.4 million - Cash, cash equivalents and marketable securities (Cash) was
$394.1 million $5.9 million
Key Operational Highlights
Psychiatry Portfolio
- Fanapt® (iloperidone): Vanda announced in April 2024 that the
U.S. Food and Drug Administration (FDA) approved Fanapt® as a first line treatment of acute bipolar I disorder in adults. This approval of Fanapt® for acute bipolar I disorder significantly expands the addressable patient population. Patent exclusivity is expected to last at least through late 2027. Vanda is initiating a host of commercial activities, including the expansion of its existing sales force, a prescriber awareness program and a comprehensive marketing program. - Milsaperidone: Vanda expects to submit a New Drug Application (NDA) for milsaperidone (also known as VHX-896 and P-88), the active metabolite of Fanapt®, in schizophrenia and acute bipolar I disorder to the FDA in early-2025. If approved, there are pending patent applications that, if issued, could extend exclusivity into the 2040s.
- Fanapt® LAI: Vanda expects to initiate a Phase III program for the long acting injectable (LAI) formulation of Fanapt® by the end of 2024. Fanapt® LAI could reach the U.S. market after 2026 and there are pending patent applications that, if issued, could extend exclusivity into the 2040s.
- Vanda is currently planning clinical programs to test the efficacy of Fanapt® and milsaperidone in the treatment of depressive symptoms which, if successful, will significantly expand the addressable patient population.
HETLIOZ® (tasimelteon)
- Vanda is currently planning to initiate a HETLIOZ LQ® program in pediatric insomnia. Although exact estimates of prevalence of insomnia in children are difficult to quantify, it is estimated that 20
-40% of children experience significant sleep problems.1,2 There are currently no approved treatments for pediatric insomnia. If ultimately approved for marketing, the addressable patient population for HETLIOZ LQ® would be significantly expanded and market exclusivity would be expected to last into the 2040s. - Vanda announced in March 2024 that it received a complete response letter (CRL) from the FDA related to the supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of insomnia. Vanda is reviewing the CRL and evaluating its next steps. In addition to insomnia, Vanda continues to pursue FDA approval of HETLIOZ® in the treatment of jet lag disorder where the final agency rejection of our application is being challenged in the
U.S. Court of Appeals for the D.C. Circuit. - Vanda announced in April 2024 that the
U.S. Supreme Court denied its petition for a writ of certiorari to review the decision of theU.S. Court of Appeals for the Federal Circuit in Vanda's HETLIOZ® Abbreviated New Drug Application litigation against Teva PharmaceuticalsUSA , Inc. (Teva), Apotex Inc. and Apotex Corp (together, Apotex). The lower court decision held that certain claims of Vanda'sU.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 were invalid. Vanda's suit assertingU.S. Patent No. 11,285,129 will be infringed by Teva's and Apotex's generic versions of HETLIOZ® is currently pending in theU.S. District Court for the District ofDelaware .
PONVORY® (ponesimod)
- Vanda expects to complete the transition of PONVORY® from Janssen and commercially launch the product for multiple sclerosis in the third quarter of 2024. Vanda is initiating a host of commercial activities including the creation of a specialty sales force, a prescriber awareness program and a comprehensive marketing program. Currently approved as a once-a-day oral treatment for people with multiple sclerosis, PONVORY® has a differentiated profile from other drugs in the class with high specificity and rapid reversibility, making for a versatile use to address the needs of people with multiple sclerosis and exclusivity is expected to last into the 2040s.
- Positive results from a Phase II clinical study for PONVORY® in the treatment of psoriasis were previously published in Lancet where PONVORY® demonstrated significant effects in both induction and maintenance of response.3 Vanda expects to file an Investigational New Drug (IND) application with the FDA for PONVORY® in the treatment of psoriasis. Vanda expects to initiate a Phase III study for PONVORY® in the treatment of psoriasis by the end of 2024. If ultimately approved for marketing, PONVORY® would be the first oral sphingosine-1-phosphate (S1P) analog approved for the treatment of psoriasis and would significantly expand the addressable patient population of PONVORY®, with over 8 million people diagnosed with psoriasis in the
U.S. 4 - Vanda expects to file an IND application with the FDA for PONVORY® in the treatment of ulcerative colitis. Vanda expects to initiate a Phase III study for PONVORY® in the treatment of ulcerative colitis by the end of 2024. If ultimately approved for marketing, PONVORY® would follow other oral sphingosine-1-phosphate (S1P) analogs approved for the treatment of ulcerative colitis and would significantly expand the addressable patient population of PONVORY®, with an estimated prevalence in the
U.S. of approximately 2 million individuals.5
Tradipitant
- The NDA for tradipitant for the treatment of symptoms of gastroparesis is under review by the FDA with a PDUFA target action date of September 18, 2024. Gastroparesis is a significant unmet medical need with the last treatment option approved over 40 years ago and an estimated prevalence in the
U.S. of over 6 million individuals.6 - The second Phase III clinical study of tradipitant in the treatment of motion sickness is fully enrolled and results are expected in the second quarter of 2024. The efficacy of tradipitant in the treatment of motion sickness has previously been demonstrated in two clinical studies in which tradipitant was effective in preventing vomiting associated with motion. Vanda expects to submit an NDA for the treatment of motion sickness to the FDA in the fourth quarter of 2024. An eventual NDA approval of tradipitant in the treatment of motion sickness would significantly expand the addressable patient population, with approximately
30% of theU.S. population reported to suffer from motion sickness under ordinary travel conditions that include sea, air and land.7
Early-Stage Programs
- The Phase II study of VSJ-110 for the treatment of dry eye is ongoing and more than
50% enrolled. - The Phase I clinical study for VCA-894A in the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, expects to enroll the patient in mid-2024.
- The Phase I clinical study of VTR-297 for the treatment of onychomycosis, a fungal infection of the nail, was initiated in April 2024.
- VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for treatment of acute performance anxiety in social situations.
GAAP Financial Results
Net loss was
2024 Financial Guidance
Given continuing uncertainties surrounding the U.S. market for HETLIOZ® for the treatment of Non-24 as a result of continued generic competition in the
Conference Call
Vanda has scheduled a conference call for today, Wednesday, May 8, 2024, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2594340. A replay of the call will be available on Wednesday, May 8, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, May 15, 2024 at 11:59 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 2594340.
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
- Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, Liao D, Bixler EO. Prevalence of insomnia symptoms in a general population sample of young children and preadolescents: gender effects. Sleep Med. 2014 Jan;15(1):91-5. doi: 10.1016/j.sleep.2013.08.787. Epub 2013 Oct 16. PMID: 24333223; PMCID: PMC3912735.
- Fricke-Oerkermann L, Plück J, Schredl M, Heinz K, Mitschke A, Wiater A, Lehmkuhl G. Prevalence and course of sleep problems in childhood. Sleep. 2007 Oct;30(10):1371-7. doi: 10.1093/sleep/30.10.1371. PMID: 17969471; PMCID: PMC2266270.
- Vaclavkova A, Chimenti S, Arenberger P, Holló P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D. Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Dec 6;384(9959):2036-45. doi: 10.1016/S0140-6736(14)60803-5. Epub 2014 Aug 10. PMID: 25127208.
- Datamonitor Healthcare – Psoriasis Patient-Based Market Forecast published March 2023.
- Datamonitor Healthcare – Ulcerative Colitis Patient-Based Market Forecast published March 2023.
- Rey et al J Neurogastroenterol Motil, Jan 2012.
- Turner M, Griffin MJ. Motion sickness in public road transport: passenger behavior and susceptibility. Ergonomics. 1999: 42: 444-461.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, statements regarding the advancement of Vanda's clinical development pipeline and strengthening of its commercial presence, Vanda's plans for pursuit of FDA approval of tradipitant in the treatment of symptoms of gastroparesis and the treatment of motion sickness, HETLIOZ® in the treatments of insomnia and jet lag disorder, Vanda's expectations regarding the timing of the FDA's decisions with respect to the sNDAs for HETLIOZ® and the NDA for tradipitant, Vanda's plans for a LAI formulation of Fanapt®, the timing of a submission of an NDA for milsaperidone, the potential for PONVORY® to treat psoriasis and ulcerative colitis, the planned patient enrollment for a clinical study for VCA-894A, the planned launch of PONVORY® in the US and the ongoing launch of Fanapt® in acute bipolar I disorder, the planned clinical programs to test Fanapt® and milsaperidone in depressive symptoms and the planned Hetlioz LQ® program in pediatric insomnia are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to complete the clinical development of the products in its pipeline and obtain regulatory approval and market acceptance of these products, Vanda's ability to obtain FDA approval of the sNDAs for HETLIOZ® and the NDA for tradipitant, the FDA's ability to meet the PDUFA target action date for the NDA for tradipitant, the FDA's assessment of the sufficiency of the data packages included in Vanda's regulatory submissions for HETLIOZ® and tradipitant, Vanda's ability to obtain approval for milsaperidone in the treatment of schizophrenia and acute bipolar I disorder, the results of any clinical trials conducted for PONVORY® in the treatment of other inflammatory/autoimmune disorders, Vanda's ability to obtain regulatory approval of HETLIOZ® and PONVORY® for any additional indications, Vanda's ability to complete the clinical program for tradipitant in the treatment of motion sickness, the planned clinical programs to test Fanapt® and milsaperidone in depressive symptoms and Vanda's ability to execute the planned launch of PONVORY® in the US and ongoing launch of Fanapt®. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified 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 Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except for share and per share amounts) (unaudited) | |||
Three Months Ended | |||
March 31 | March 31 | ||
Revenues: | |||
Fanapt® net product sales | $ 20,579 | $ 22,882 | |
HETLIOZ® net product sales | 20,053 | 39,616 | |
PONVORY® net product sales | 6,830 | — | |
Total revenues | 47,462 | 62,498 | |
Operating expenses: | |||
Cost of goods sold excluding amortization | 3,440 | 4,774 | |
Research and development | 21,154 | 19,237 | |
Selling, general and administrative | 30,085 | 36,104 | |
Intangible asset amortization | 2,018 | 379 | |
Total operating expenses | 56,697 | 60,494 | |
Income (loss) from operations | (9,235) | 2,004 | |
Other income | 4,571 | 3,524 | |
Income (loss) before income taxes | (4,664) | 5,528 | |
Provision (benefit) for income taxes | (518) | 2,276 | |
Net income (loss) | $ (4,146) | $ 3,252 | |
Net income (loss) per share, basic | $ (0.07) | $ 0.06 | |
Net income (loss) per share, diluted | $ (0.07) | $ 0.06 | |
Weighted average shares outstanding, basic | 57,760,940 | 57,011,396 | |
Weighted average shares outstanding, diluted | 57,760,940 | 57,400,152 | |
VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) | |||
March 31 | December 31 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 125,158 | $ 135,821 | |
Marketable securities | 268,984 | 252,443 | |
Accounts receivable, net | 36,713 | 34,155 | |
Inventory | 1,505 | 1,357 | |
Prepaid expenses and other current assets | 7,065 | 9,170 | |
Total current assets | 439,425 | 432,946 | |
Property and equipment, net | 2,306 | 2,037 | |
Operating lease right-of-use assets | 6,742 | 7,103 | |
Intangible assets, net | 119,351 | 121,369 | |
Deferred tax assets | 75,341 | 75,000 | |
Non-current inventory and other | 9,517 | 9,985 | |
Total assets | $ 652,682 | $ 648,440 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 37,773 | $ 38,460 | |
Product revenue allowances | 55,569 | 49,237 | |
Total current liabilities | 93,342 | 87,697 | |
Operating lease non-current liabilities | 6,514 | 7,006 | |
Other non-current liabilities | 8,831 | 8,827 | |
Total liabilities | 108,687 | 103,530 | |
Stockholders' equity: | |||
Common stock | 58 | 58 | |
Additional paid-in capital | 703,858 | 700,274 | |
Accumulated other comprehensive loss | (383) | (30) | |
Accumulated deficit | (159,538) | (155,392) | |
Total stockholders' equity | 543,995 | 544,910 | |
Total liabilities and stockholders' equity | $ 652,682 | $ 648,440 | |
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-first-quarter-2024-financial-results-302140408.html
SOURCE Vanda Pharmaceuticals Inc.
FAQ
What were Vanda Pharmaceuticals' revenues for Q1 2024?
What treatment was Fanapt® approved for in Q1 2024?
When is the commercial launch of Ponvory expected?
What NDA submission is planned for early-2025 by Vanda?
What is the expected PDUFA date for Tradipitant?
