Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results
- Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024
- Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024
-
Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of
February 21, 2026 -
Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of
December 30, 2025 - Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025
"Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said
Financial Highlights
- Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were
$50.0 million in the first quarter of 2025, a 5% increase compared to$47.5 million in the first quarter of 2024. - Fanapt® net product sales were
$23.5 million in the first quarter of 2025, a 14% increase compared to$20.6 million in the first quarter of 2024. - HETLIOZ® net product sales were
$20.9 million in the first quarter of 2025, a 4% increase compared to$20.1 million in the first quarter of 2024. - PONVORY® net product sales were
$5.6 million in the first quarter of 2025, a decrease of 18% compared to$6.8 million in the first quarter of 2024. - Net loss was
$29.5 million in the first quarter of 2025 compared to net loss of$4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of$15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities. - Cash, cash equivalents and marketable securities (Cash) was
$340.9 million as ofMarch 31, 2025 , representing a decrease to Cash of$33.7 million compared toDecember 31, 2024 . The decrease to Cash reflects the payment of$15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab.
Key Operational Highlights – Commercial
Fanapt® (iloperidone)
- Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period.
- Fanapt® total prescriptions (TRx) for the week of
April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives.
HETLIOZ® (tasimelteon)
- Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2
PONVORY® (ponesimod)
- Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In
April 2025 , new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives.
Key Operational Highlights – Regulatory & Clinical Development
Key Regulatory Milestones
- Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the
U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date ofDecember 30, 2025 . - Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the
European Medicines Agency (EMA) in Q4 2024. - HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024.
- Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of
February 21, 2026 . - Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025.
Key Clinical Highlights
Fanapt® (iloperidone)
- Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing.
- Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon.
Bysanti™ (milsaperidone)
- The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of
February 21, 2026 . Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s. - Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025
American Society of Clinical Psychopharmacology annual meeting inScottsdale, Arizona . - The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026.
HETLIOZ® (tasimelteon)
- HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing.
- Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA.
PONVORY® (ponesimod)
- Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024.
Tradipitant
- The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of
December 30, 2025 . - In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025.
Imsidolimab
- In
February 2025 , Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A BLA for GPP is expected to be submitted to the FDA in 2025.
Early-Stage Program Highlights
- VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate the Phase III program in 2025.
- The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025.
GAAP Financial Results
Net loss was
2025 Financial Guidance
Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025:
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Full Year 2025 Financial Objectives |
Full Year 2025 Guidance |
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Total revenues
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Year-end 2025 Cash
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Conference Call
Vanda has scheduled a conference call for today,
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
- IQVIA Prescription Data
- Based on blended data analysis
About
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
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s 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 continue to grow its business; Vanda's ability to obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; 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.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except for share and per share amounts) (unaudited) |
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Three Months Ended |
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Revenues: |
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Fanapt® net product sales |
$ 23,545 |
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$ 20,579 |
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HETLIOZ® net product sales |
20,872 |
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20,053 |
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PONVORY® net product sales |
5,624 |
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6,830 |
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Total revenues |
50,041 |
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47,462 |
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Operating expenses: |
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Cost of goods sold excluding amortization |
3,521 |
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3,440 |
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Research and development |
35,712 |
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21,154 |
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Selling, general and administrative |
50,084 |
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30,085 |
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Intangible asset amortization |
1,752 |
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2,018 |
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Total operating expenses |
91,069 |
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56,697 |
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Loss from operations |
(41,028) |
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(9,235) |
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Other income, net |
3,660 |
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4,571 |
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Loss before income taxes |
(37,368) |
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(4,664) |
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Benefit for income taxes |
(7,874) |
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(518) |
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Net loss |
$ (29,494) |
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$ (4,146) |
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Net loss per share, basic |
$ (0.50) |
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$ (0.07) |
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Net loss per share, diluted |
$ (0.50) |
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$ (0.07) |
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Weighted average shares outstanding, basic |
58,527,775 |
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57,760,940 |
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Weighted average shares outstanding, diluted |
58,527,775 |
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57,760,940 |
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CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ 111,796 |
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$ 102,316 |
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Marketable securities |
229,112 |
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272,327 |
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Accounts receivable, net |
44,603 |
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47,101 |
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Inventory |
1,923 |
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1,726 |
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Prepaid expenses and other current assets |
20,476 |
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15,420 |
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Total current assets |
407,910 |
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438,890 |
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Property and equipment, net |
2,439 |
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2,132 |
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Operating lease right-of-use assets |
5,208 |
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5,602 |
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Finance lease right-of-use assets |
4,828 |
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4,943 |
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Intangible assets, net |
112,344 |
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114,096 |
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Deferred tax assets |
89,147 |
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81,440 |
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Non-current inventory and other |
10,060 |
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9,101 |
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Total assets |
$ 631,936 |
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$ 656,204 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
$ 45,279 |
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$ 39,086 |
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Product revenue allowances |
58,644 |
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60,895 |
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Total current liabilities |
103,923 |
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99,981 |
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Operating lease non-current liabilities |
4,404 |
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4,944 |
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Finance lease non-current liabilities |
2,947 |
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3,146 |
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Other non-current liabilities |
9,245 |
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9,587 |
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Total liabilities |
120,519 |
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117,658 |
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Stockholders' equity: |
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Common stock |
59 |
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58 |
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Additional paid-in capital |
714,761 |
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712,706 |
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Accumulated other comprehensive income |
383 |
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74 |
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Accumulated deficit |
(203,786) |
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(174,292) |
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Total stockholders' equity |
511,417 |
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538,546 |
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Total liabilities and stockholders' equity |
$ 631,936 |
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$ 656,204 |
Corporate Contact:
Senior Vice President, Chief Financial Officer and Treasurer
202-734-3400
pr@vandapharma.com
Collected Strategies
VANDA-CS@collectedstrategies.com
Follow us on X @vandapharma
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