Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results
- Vanda added PONVORY® to their portfolio alongside Fanapt® and HETLIOZ®.
- They advanced their clinical development pipeline with three NDA and sNDA submissions for insomnia, bipolar disorder, and gastroparesis.
- - Total net product sales from HETLIOZ®, Fanapt®, and PONVORY® decreased by 24% in 2023 compared to 2022.
- - Net loss was $2.4 million in the fourth quarter of 2023 compared to net income of $6.9 million in the fourth quarter of 2022.
Insights
The reported net income decrease for Vanda Pharmaceuticals from $6.3 million in full year 2022 to $2.5 million in full year 2023 indicates a contraction in profitability, which is a critical metric for investors. The 24% decline in annual revenue and the 30% decrease in Q4 sales year-over-year primarily due to generic competition for HETLIOZ® could be concerning for future revenue streams. Additionally, the cash reserves reduction by $78.6 million year-over-year, although partially due to the strategic acquisition of PONVORY®, might raise questions about the company's liquidity and financial resilience, especially without 2024 financial guidance due to ongoing patent litigation uncertainties.
The acquisition of PONVORY® could be a strategic move for Vanda, diversifying their portfolio with a treatment for relapsing forms of multiple sclerosis, an area with significant patient need. However, the initial sales post-acquisition appear modest at $1.6 million. The market will be watching the ongoing transition and integration of PONVORY® closely, as well as the potential impact of the newly allowed patent which could provide long-term market protection until 2042. The clinical development pipeline advancements, including the sNDA submissions and NDA acceptance for tradipitant, are positive indicators of Vanda's commitment to innovation and could be pivotal for future growth.
The legal challenges Vanda faces, including the lawsuit against the FDA over the review process for the insomnia sNDA and the ongoing HETLIOZ® patent litigation, introduce a significant element of uncertainty. The outcomes of these legal proceedings could have material implications for the company's market exclusivity and regulatory trajectory. The notice of allowance for the PONVORY® patent and the favorable summary judgment against the FDA regarding the jet lag sNDA could be seen as positive legal developments, potentially strengthening Vanda's intellectual property position and regulatory standing.
- Full year 2023 revenues were
$192.6 million - PONVORY® acquisition completed in Q4 2023 and transition ongoing
- 3 FDA PDUFA target action dates in 2024
- Ended 2023 with approximately
$388 million
"Despite significant external commercial and regulatory challenges, last year was a landmark year for Vanda, as we supported our commercial programs and, through a transformational deal, we added PONVORY® to our portfolio alongside Fanapt® and HETLIOZ®," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "At the same time, we advanced our clinical development pipeline with three NDA and sNDA submissions for insomnia, bipolar disorder and gastroparesis. Looking forward to this year, we are committed to advancing our clinical development pipeline and strengthening our commercial presence with a portfolio of innovative products serving unmet patient needs."
Financial Highlights
Fourth Quarter of 2023
- Total net product sales from HETLIOZ®, Fanapt® and PONVORY® were
$45.3 million 30% decrease compared to$64.5 million 17% increase compared to$38.8 million - HETLIOZ® net product sales were
$21.1 million 47% decrease compared to$40.1 million 20% increase compared to$17.5 million U.S. - Fanapt® net product sales were
$22.6 million 7% decrease compared to$24.4 million 6% increase compared to$21.3 million - PONVORY® net product sales were
$1.6 million - Net loss was
$2.4 million $6.9 million $0.1 million - Cash, cash equivalents and marketable securities (Cash) was
$388.3 million $101.6 million $100.0 million
Full Year 2023
- Total net product sales from HETLIOZ®, Fanapt® and PONVORY® were
$192.6 million 24% decrease compared to$254.4 million - HETLIOZ® net product sales were
$100.2 million 37% decrease compared to$159.7 million U.S. - Fanapt® net product sales were
$90.9 million 4% decrease compared to$94.7 million - PONVORY® net product sales were
$1.6 million - Net income was
$2.5 million $6.3 million - Cash, cash equivalents and marketable securities (Cash) was
$388.3 million $78.6 million 17% , compared to December 31, 2022. During the period, Vanda completed the acquisition of PONVORY® from Janssen for$100.0 million
Key Operational Highlights
HETLIOZ® (tasimelteon)
- The supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of insomnia is under review by the
U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of March 4, 2024. Vanda announced that on February 4, 2024, it received a notification from the FDA stating that the FDA had identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. On February 6, 2024, Vanda filed suit in theU.S. District Court for theDistrict of Columbia (D.C. District Court) challenging the FDA's conduct in reviewing the insomnia sNDA. Vanda is asking the D.C. District Court to compel the FDA to adhere to the legally mandated 180-day review period for sNDAs and to declare as unlawful and void the regulations the FDA relies upon to issue complete response letters. - Vanda is also continuing to pursue FDA approval for HETLIOZ® in the treatment of jet lag disorder. Vanda announced in January 2024 that the D.C. District Court granted Vanda's motion for summary judgment on its claim against the FDA for unlawfully delaying a hearing on the approvability of Vanda's sNDA for HETLIOZ® in the treatment of jet lag disorder. The D.C. District Court ordered the FDA to either finally resolve Vanda's jet lag sNDA or commence a hearing on the sNDA on or before March 5, 2024.
- In January 2024, Vanda filed a petition for a writ of certiorari with the
U.S. Supreme Court to review the decision of theU.S. Court of Appeals for the Federal Circuit in Vanda's HETLIOZ® Abbreviated New Drug Application (ANDA) litigation against Teva PharmaceuticalsUSA , Inc. (Teva), Apotex Inc. and Apotex Corp. (collectively, Apotex). Teva and Apotex have waived their opportunity to respond to Vanda's petition, which is now ripe for decision by theU.S. Supreme Court.
Fanapt® (iloperidone)
- The article "Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study" was published in January 2024 in the Journal of Clinical Psychiatry.1 The findings of this pivotal study have been submitted to the FDA as part of Vanda's sNDA for Fanapt® in the treatment of bipolar I disorder in adults.
- The sNDA for Fanapt® in the treatment of bipolar I disorder in adults is under review by the FDA with a PDUFA target action date of April 2, 2024.
PONVORY® (ponesimod)
- Vanda completed the acquisition of the
U.S. and Canadian rights to PONVORY® from Janssen for$100.0 million - Vanda announced in January 2024 that the
U.S. Patent and Trademark Office (USPTO) had issued a notice of allowance for its PONVORY® patent application, 17/962,968, covering methods for reducing clinical management events before or during the treatment of multiple sclerosis and methods for reinstating treatment after missed doses. When issued, the patent is anticipated to expire on October 10, 2042. Upon issuance, Vanda intends to list this patent in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
Tradipitant
- The article "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" was published in January 2024 in the Clinical Gastroenterology and Hepatology Journal.2 The findings of this pivotal study as well as a previously reported positive placebo-controlled study in diabetic and idiopathic gastroparesis have been submitted to the FDA as part of Vanda's New Drug Application (NDA) for tradipitant in the treatment of symptoms of gastroparesis in adults.3
- In December 2023, Vanda announced that the NDA for tradipitant for the treatment of symptoms of gastroparesis was accepted for filing and is under review by the FDA with a PDUFA target action date of September 18, 2024.
- The second Phase III study of tradipitant in the treatment of motion sickness is over
50% enrolled. In May 2023, Vanda previously announced positive results from its first Phase III study of tradipitant in the treatment of motion sickness. Vanda plans to pursue FDA approval upon completion of the clinical development program.
Early-Stage Programs
- In January 2024, Vanda announced that the FDA had approved the Investigational New Drug (IND) application to evaluate VCA-894A for 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.
- In January 2024, Vanda announced that the FDA had also approved the IND to evaluate VTR-297 for the treatment of onychomycosis, a fungal infection of the nail.
Other Legal Updates
- Vanda announced in January 2024 that
the United States Court of Federal Claims denied in part theU.S. government's motion to dismiss Vanda's claims against theU.S. for the FDA's uncompensated taking of Vanda's trade secrets and confidential information, thereby allowing Vanda's lawsuit to proceed. Vanda is seeking compensation from theU.S. for the takings it contends occurred through the FDA's improper communication and disclosure of trade secrets and confidential information to certain generic drug manufacturers. Vanda now intends to engage in discovery to support its claims.
GAAP Financial Results
Net loss was
Net income was
2024 Financial Guidance
Given uncertainties surrounding the U.S. market for HETLIOZ® for the treatment of Non-24 as a result of the ongoing HETLIOZ® patent litigation and the at-risk launch of generic versions of HETLIOZ®, Vanda is unable to provide 2024 financial guidance at this time.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, February 7, 2024, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2023 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 8053170. A replay of the call will be available on Wednesday, February 7, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, February 14, 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 8053170.
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
- Torres R, Czeisler EL, Chadwick SR, et al. Efficacy and safety of iloperidone in bipolar mania: a double-blind, placebo-controlled study. J Clin Psychiatry. https://doi.org/10.4088/JCP.23m14966
- Carlin, J. L., Polymeropoulos, C., Camilleri, M., Lembo, A., Fisher, M., Kupersmith, C., Madonick, D., Moszczynski, P., Smieszek, S., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. (2024). The efficacy of tradipitant in patients with diabetic and idiopathic gastroparesis in phase III randomized placebo-controlled clinical trial. Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2024.01.005
- Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H. P., & Polymeropoulos, M. H. (2021). Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology, 160(1), 76–87.e4. https://doi.org/10.1053/j.gastro.2020.07.029
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 HETLIOZ® in the treatments of insomnia and jet lag disorder, Fanapt® in the treatment of bipolar I in adults and tradipitant in the treatment of symptoms of gastroparesis and the treatment of motion sickness, Vanda's expectations regarding the timing of the FDA's decisions with respect to the sNDAs for HETLIOZ® and Fanapt® and the NDA for tradipitant, the potential for PONVORY® to treat a diverse group of inflammatory/autoimmune disorders, the USPTO's plans to issue the new PONVORY® patent, the anticipated life of the patent and Vanda's intentions to list the patent in the Orange Book 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 Fanapt® and the NDA for tradipitant, the FDA's ability to meet the PDUFA target action dates for the sNDAs for HETLIOZ® and Fanapt® and the NDA for tradipitant, the FDA's assessment of the sufficiency of the data packages included in Vanda's regulatory submissions for HETLIOZ®, Fanapt® and tradipitant, Vanda's ability to complete the clinical program for tradipitant in the treatment of motion sickness, the results of any clinical trials conducted for PONVORY® in the treatment of other inflammatory/autoimmune disorders and Vanda's ability to obtain regulatory approval of PONVORY® for any such additional indications, the payment by Vanda to the USPTO of all fees required prior to the issuance of the new PONVORY® patent, the ultimate issuance of the patent by the USPTO and Vanda's ability to protect its intellectual property rights and defend the new PONVORY® patent against any attempt to invalidate it. 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 | Twelve Months Ended | ||||||
December 31 | December 31 | December 31 | December 31 | ||||
Revenues: | |||||||
HETLIOZ® net product sales | $ 21,072 | $ 40,101 | $ 100,167 | $ 159,655 | |||
Fanapt® net product sales | 22,599 | 24,381 | 90,873 | 94,727 | |||
PONVORY® net product sales | 1,600 | — | 1,600 | — | |||
Total revenues | 45,271 | 64,482 | 192,640 | 254,382 | |||
Operating expenses: | |||||||
Cost of goods sold excluding amortization | 3,460 | 6,238 | 14,796 | 24,282 | |||
Research and development | 24,339 | 18,454 | 76,823 | 85,770 | |||
Selling, general and administrative | 23,613 | 32,782 | 112,883 | 136,485 | |||
Intangible asset amortization | 953 | 379 | 2,090 | 1,516 | |||
Total operating expenses | 52,365 | 57,853 | 206,592 | 248,053 | |||
Income (loss) from operations | (7,094) | 6,629 | (13,952) | 6,329 | |||
Other income | 5,433 | 2,984 | 20,291 | 4,971 | |||
Income (loss) before income taxes | (1,661) | 9,613 | 6,339 | 11,300 | |||
Provision for income taxes | 739 | 2,752 | 3,830 | 5,025 | |||
Net income (loss) | $ (2,400) | $ 6,861 | $ 2,509 | $ 6,275 | |||
Net income (loss) per share, basic | $ (0.04) | $ 0.12 | $ 0.04 | $ 0.11 | |||
Net income (loss) per share, diluted | $ (0.04) | $ 0.12 | $ 0.04 | $ 0.11 | |||
Weighted average shares outstanding, basic | 57,532,309 | 56,651,984 | 57,380,975 | 56,461,877 | |||
Weighted average shares outstanding, diluted | 57,532,309 | 57,188,551 | 57,557,911 | 56,983,171 | |||
VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) | |||
December 31 | December 31 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 135,821 | $ 135,029 | |
Marketable securities | 252,443 | 331,830 | |
Accounts receivable, net | 34,155 | 33,512 | |
Inventory | 1,357 | 1,194 | |
Prepaid expenses and other current assets | 9,170 | 17,727 | |
Total current assets | 432,946 | 519,292 | |
Property and equipment, net | 2,037 | 2,573 | |
Operating lease right-of-use assets | 7,103 | 8,400 | |
Intangible assets, net | 121,369 | 18,565 | |
Deferred tax assets | 75,000 | 74,039 | |
Non-current inventory and other | 9,985 | 11,378 | |
Total assets | $ 648,440 | $ 634,247 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 38,460 | $ 45,551 | |
Product revenue allowances | 49,237 | 45,885 | |
Total current liabilities | 87,697 | 91,436 | |
Operating lease non-current liabilities | 7,006 | 8,813 | |
Other non-current liabilities | 8,827 | 6,800 | |
Total liabilities | 103,530 | 107,049 | |
Stockholders' equity: | |||
Common stock | 58 | 57 | |
Additional paid-in capital | 700,274 | 686,235 | |
Accumulated other comprehensive loss | (30) | (1,193) | |
Accumulated deficit | (155,392) | (157,901) | |
Total stockholders' equity | 544,910 | 527,198 | |
Total liabilities and stockholders' equity | $ 648,440 | $ 634,247 | |
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.
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