WASHINGTON, Feb. 13, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2024.
"Strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hetlioz and Ponvory. The Fanapt long acting injectable program, the NDA for Bysanti for bipolar disorder and schizophrenia along with its development for major depressive disorder have the potential to drive future growth in our psychiatry portfolio for many years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Tradipitant's NDA for motion sickness was filed with a potential approval this year, while we are pursuing approval in gastroparesis and the development of tradipitant to improve tolerability of GLP-1 analog Wegovy. Our anti-inflammatory portfolio, anchored by Ponvory, was strengthened with the addition of imsidolimab from Anaptys, an IL-36 receptor inhibitor for the treatment of generalized pustular psoriasis. We plan to file a BLA later this year while we are exploring registration in Europe and Japan as well as the development of this novel drug for other inflammatory disorders with an unopposed action of the IL-36 system. In 2024 we returned to revenue growth driven by the commercial launches in bipolar disorder and multiple sclerosis and advanced our development pipeline with a number of products at or near marketing applications. All this was achieved by the hard work, ingenuity and efficiency of our organization and its wonderful people."
Financial Highlights
Fourth Quarter of 2024
Full Year 2024
Key Operational Highlights
Fanapt® (iloperidone)
Bysanti™ (milsaperidone)
HETLIOZ® (tasimelteon)
PONVORY® (ponesimod)
Tradipitant
Imsidolimab
Early-Stage Program Highlights
Key Regulatory Milestones
GAAP Financial Results
Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023. Diluted net loss per share was $0.08 in the fourth quarter of 2024 compared to diluted net loss per share of $0.04 in the fourth quarter of 2023.
Net loss was $18.9 million for the full year 2024 compared to net income of $2.5 million for the full year 2023. Diluted net loss per share was $0.33 for the full year 2024 compared to diluted net income per share of $0.04 for the full year 2023.
2025 Financial Guidance and 2030 Revenue Targets
Vanda expects to achieve the following financial objectives in 2025:
Full Year 2025 Financial Objectives | Full Year 2025 Guidance |
Total revenues | $210 to $250 million |
Vanda is providing 2030 revenue targets. For the psychiatry portfolio alone, Vanda is targeting annual revenue in excess of $750 million in 2030, assuming the potential approval of Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia in early 2026, the potential approval of Bysanti™ for the treatment of MDD, and the potential approval of Fanapt® LAI. Vanda is also targeting total annual revenue in excess of $1 billion in 2030.
Conference Call
Vanda has scheduled a conference call for today, Thursday, February 13, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 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 2881765. A replay of the call will be available on Thursday, February 13, 2025, beginning at 8:30 PM ET and will be accessible until Thursday, February 20, 2025 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 2881765.
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
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, the guidance provided under "2025 Financial Guidance and 2030 Revenue Targets" above and the related implied growth of Vanda's business, and statements regarding Vanda's plans for pursuit of FDA approval of BysantiTM for the treatments of acute bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines; Vanda's expectations with respect to the growth opportunities for its psychiatry frachise; Vanda's consideration of foreign regulatory approval for imsidolimab and its potential development for other inflammatory disorders; Vanda's clinical development plans and expected timelines for Fanapt® LAI, BysantiTM 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 commercial and therapeutic potential for BysantiTM; the potential to extend patent exclusivity for BysantiTM into the 2040s; the anticipated timing of the initiation and completion of technology transfer activities and the preparation of regulatory filings in the US and EU for imsidolimab; and the prevalence of PV 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 psychiatry portfolio and overall business; the results of Vanda's review of foreign regulatory opportunities for imsidolmab; Vanda's ability to identify additional indications for imsidolimab; Vanda's ability to complete and submit to the FDA the NDA for BysantiTM for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025; Vanda's ability to complete and submit the BLA for imsidolimab for the treatment of GPP in 2025; Vanda's ability to complete the Phase III clinical study for BysantiTM for MDD and receive results in 2026; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; Vanda's ability to complete the clinical development of, obtain regulatory approval for, and successfully commercialize, BysantiTM for the treatments of acute bipolar I disorder, schizophrenia and MDD; Vanda's ability to satisfy the conditions necessary to extend BysantiTM's patent exclusivity into the 2040s; Vanda's ability to initiate and complete the technology transfer activities and prepare the BLA and MAA for imsidolimab in the specified timeframes; and the accuracy of the estimate regarding the prevalence of PV. 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 U.S. Securities and Exchange Commission, which are available at www.sec.gov.
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 | Twelve Months Ended | ||||||
December 31 | December 31 | December 31 | December 31 | ||||
Revenues: | |||||||
Fanapt® net product sales | $ 26,649 | $ 22,599 | $ 94,297 | $ 90,873 | |||
HETLIOZ® net product sales | 20,044 | 21,072 | 76,675 | 100,167 | |||
PONVORY® net product sales | 6,492 | 1,600 | 27,800 | 1,600 | |||
Total revenues | 53,185 | 45,271 | 198,772 | 192,640 | |||
Operating expenses: | |||||||
Cost of goods sold excluding amortization | 2,590 | 3,460 | 11,314 | 14,796 | |||
Research and development | 19,840 | 24,339 | 74,431 | 76,823 | |||
Selling, general and administrative | 39,282 | 23,613 | 146,414 | 112,883 | |||
Intangible asset amortization | 1,752 | 953 | 7,273 | 2,090 | |||
Total operating expenses | 63,464 | 52,365 | 239,432 | 206,592 | |||
Loss from operations | (10,279) | (7,094) | (40,660) | (13,952) | |||
Other income, net | 3,782 | 5,433 | 17,739 | 20,291 | |||
Income (loss) before income taxes | (6,497) | (1,661) | (22,921) | 6,339 | |||
Provision (benefit) for income taxes | (1,585) | 739 | (4,021) | 3,830 | |||
Net income (loss) | $ (4,912) | $ (2,400) | $ (18,900) | $ 2,509 | |||
Net income (loss) per share, basic | $ (0.08) | $ (0.04) | $ (0.33) | $ 0.04 | |||
Net income (loss) per share, diluted | $ (0.08) | $ (0.04) | $ (0.33) | $ 0.04 | |||
Weighted average shares outstanding, basic | 58,308,487 | 57,532,309 | 58,149,087 | 57,380,975 | |||
Weighted average shares outstanding, diluted | 58,308,487 | 57,532,309 | 58,149,087 | 57,557,911 | |||
VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) | |||
December 31 | December 31 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 102,316 | $ 135,821 | |
Marketable securities | 272,327 | 252,443 | |
Accounts receivable, net | 47,101 | 34,155 | |
Inventory | 1,726 | 1,357 | |
Prepaid expenses and other current assets | 15,420 | 9,170 | |
Total current assets | 438,890 | 432,946 | |
Property and equipment, net | 2,132 | 2,037 | |
Operating lease right-of-use assets | 5,602 | 7,103 | |
Finance lease right-of-use assets | 4,943 | — | |
Intangible assets, net | 114,096 | 121,369 | |
Deferred tax assets | 81,440 | 75,000 | |
Non-current inventory and other | 9,101 | 9,985 | |
Total assets | $ 656,204 | $ 648,440 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 39,086 | $ 38,460 | |
Product revenue allowances | 60,895 | 49,237 | |
Total current liabilities | 99,981 | 87,697 | |
Operating lease non-current liabilities | 4,944 | 7,006 | |
Finance lease non-current liabilities | 3,146 | — | |
Other non-current liabilities | 9,587 | 8,827 | |
Total liabilities | 117,658 | 103,530 | |
Stockholders' equity: | |||
Common stock | 58 | 58 | |
Additional paid-in capital | 712,706 | 700,274 | |
Accumulated other comprehensive income (loss) | 74 | (30) | |
Accumulated deficit | (174,292) | (155,392) | |
Total stockholders' equity | 538,546 | 544,910 | |
Total liabilities and stockholders' equity | $ 656,204 | $ 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
Follow us on X @vandapharma
| Last Trade: | US$4.86 |
| Daily Change: | -0.09 -1.72 |
| Daily Volume: | 153,469 |
| Market Cap: | US$283.100M |
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