Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results
-- 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 in cash and cash equivalents
WASHINGTON, Feb. 7, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2023.
"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 in the fourth quarter of 2023, a 30% decrease
compared to $64.5 million in the fourth quarter of 2022, and a 17%
increase compared to $38.8 million in the third quarter of 2023.
-- HETLIOZ(®) net product sales were $21.1 million in the fourth quarter
of 2023, a 47% decrease compared to $40.1 million in the fourth quarter
of 2022, and a 20% increase compared to $17.5 million in the third
quarter of 2023. The decrease relative to the fourth quarter of 2022 was
the result of the at-risk launch of generic versions of HETLIOZ(®) in
the U.S.
-- Fanapt(®) net product sales were $22.6 million in the fourth quarter of
2023, a 7% decrease compared to $24.4 million in the fourth quarter of
2022, and a 6% increase compared to $21.3 million in the third quarter
of 2023.
-- PONVORY(®) net product sales were $1.6 million in the fourth quarter of
2023. These net product sales reflect the revenue generated during the
period between the product acquisition date of December 7, 2023 and
December 31, 2023.
-- 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, and net income of
$0.1 million in the third quarter of 2023.
-- Cash, cash equivalents and marketable securities (Cash) was $388.3
million as of December 31, 2023, representing a decrease to Cash of
$101.6 million compared to September 30, 2023. During the period, Vanda
completed the acquisition of PONVORY(®) from Actelion Pharmaceuticals
Ltd. (Janssen), a Johnson & Johnson Company, for $100.0 million.
Full Year 2023
-- Total net product sales from HETLIOZ(®), Fanapt(®) and PONVORY(®)
were $192.6 million for the full year 2023, a 24% decrease compared to
$254.4 million for the full year 2022.
-- HETLIOZ(®) net product sales were $100.2 million for the full year
2023, a 37% decrease compared to $159.7 million for the full year 2022.
The decrease was the result of the at-risk launch of generic versions of
HETLIOZ(®) in the U.S.
-- Fanapt(®) net product sales were $90.9 million for the full year 2023,
a 4% decrease compared to $94.7 million for the full year 2022.
-- PONVORY(®) net product sales were $1.6 million for the full year 2023.
These net product sales reflect the revenue generated during the period
between the product acquisition date of December 7, 2023 and December
31, 2023.
-- Net income was $2.5 million for the full year 2023 compared to net
income of $6.3 million for the full year 2022.
-- Cash, cash equivalents and marketable securities (Cash) was $388.3
million as of December 31, 2023, representing a decrease to Cash of
$78.6 million, or 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 the U.S. District
Court for the District 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 the U.S. Court of
Appeals for the Federal Circuit in Vanda's HETLIOZ(®) Abbreviated New
Drug Application (ANDA) litigation against Teva Pharmaceuticals USA,
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 the U.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 in December 2023 and the
transition is ongoing. PONVORY(®) is a once-daily oral selective
sphingosine-1-phosphate receptor 1 modulator, approved by the FDA and
Health Canada to treat adults with relapsing forms of multiple
sclerosis, and is a potential therapeutic candidate for the treatment of
a diverse group of inflammatory/autoimmune disorders ranging from
psoriasis to ulcerative colitis.
-- 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 the U.S. government's motion to dismiss Vanda's
claims against the U.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 the U.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 $2.4 million in the fourth quarter of 2023 compared to net income of $6.9 million in the fourth quarter of 2022. Diluted net loss per share was $0.04 in the fourth quarter of 2023 compared to diluted net income per share of $0.12 in the fourth quarter of 2022.
Net income was $2.5 million for the full year 2023 compared to net income of $6.3 million for the full year 2022. Diluted net income per share was $0.04 for the full year 2023 compared to diluted net income per share of $0.11 for the full year 2022.
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
1. 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
2. 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
3. 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 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
2023 2022 2023 2022
Revenues:
HETLIOZ
(R)
net product sales $21,072 $40,101 $100,167 $159,655
Fanapt
(R)
net product sales 22,599 24,381 90,873 94,727
PONVORY
(R)
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
2023 2022
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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