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Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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Vanda Pharmaceuticals Inc. (VNDA) announced financial and operational results for the fourth quarter and full year ended December 31, 2023. Despite significant challenges, they supported their commercial programs and 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, and are committed to advancing their clinical development pipeline and strengthening their commercial presence with innovative products.
Positive
  • 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.
Negative
  • - 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.

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 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
2023


December 31
2022


December 31
2023


December 31
2022

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
2023


December 31
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 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-fourth-quarter-and-full-year-2023-financial-results-302056697.html

SOURCE Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc.'s full year 2023 revenues were $192.6 million.

Total net product sales from HETLIOZ®, Fanapt®, and PONVORY® were $45.3 million in the fourth quarter of 2023.

Vanda Pharmaceuticals Inc.'s cash and cash equivalents was $388.3 million as of December 31, 2023.

PONVORY® net product sales were $1.6 million in the fourth quarter of 2023.

Vanda Pharmaceuticals Inc.'s net loss was $2.4 million in the fourth quarter of 2023.
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vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.