WASHINGTON, Nov. 6, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2024.
“We are very pleased with the lead indicators of the initial market response to our commercial launch of Fanapt in bipolar I disorder, a testament to the strong clinical evidence and the strength of our commercial strategy, and we look forward to continuous growth in the coming quarters. In parallel, we have launched Ponvory for multiple sclerosis and we are looking forward to increased prescriber and patient awareness in the near future. We expect Fanapt, milsaperidone and Fanapt LAI to form a diverse and expanding psychiatry franchise for years to come,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “On the research and development front, we are focused on completing in the coming months our New Drug Applications for tradipitant in motion sickness and for milsaperidone in schizophrenia and bipolar I disorder. IND filings are expected to be completed for Ponvory in ulcerative colitis and psoriasis later this quarter. We are committed to growing our revenue from our existing products and continuing to diversify our sources of revenue through indication expansion and new product development.”
Financial Highlights
Third Quarter of 2024
First Nine Months of 2024
Key Operational Highlights
Psychiatry Portfolio
HETLIOZ® (tasimelteon)
PONVORY® (ponesimod)
Tradipitant
Early-Stage Programs
GAAP Financial Results
Net loss was $5.3 million in the third quarter of 2024 compared to net income of $0.1 million in the third quarter of 2023. Diluted net loss per share was $0.09 in the third quarter of 2024 compared to diluted net income per share of $0.00 in the third quarter of 2023.
Net loss was $14.0 million in the first nine months of 2024 compared to net income of $4.9 million in the first nine months of 2023. Diluted net loss per share was $0.24 in the first nine months of 2024 compared to diluted net income per share of $0.09 in the first nine months of 2023.
2024 Financial Guidance
Vanda is updating its 2024 financial guidance and expects to achieve the following financial objectives in 2024:
Full Year 2024
Financial Objectives
Prior Full Year 2024
Guidance
Revised Full Year 2024
Guidance
Total revenues
$180 to $210 million
$190 to $210 million
Year-end 2024 Cash
$360 to $390 million
$370 to $390 million
Conference Call
Vanda has scheduled a conference call for today, Wednesday, November 6, 2024, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 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 2555000. A replay of the call will be available on Wednesday, November 6, 2024, beginning at 8:30 PM ET and will be accessible until Wednesday, November 13, 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 2555000.
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 “2024 Financial Guidance” above, and statements regarding Vanda’s plans to strengthen and grow its business and diversify its sources of revenue; Vanda’s plans for pursuit of FDA approval of milsaperidone for the treatments of schizophrenia and acute bipolar I disorder, tradipitant for the treatments of motion sickness and gastroparesis, and HETLIOZ® for the treatments of jet lag disorder and insomnia; European Medicines Agency action on the Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome; Vanda’s clinical development plans for milsaperidone for the treatment of MDD, the LAI formulation of Fanapt®, PONVORY® for the treatments of psoriasis and ulcerative colitis, tradipitant for the prevention of vomiting induced by a GLP-1 analog, VSJ-110 for the treatment of dry eye, VPO-227 for the treatment of cholera, VCA-894A for the treatment of CMT2S, VTR-297 for the treatment of onychomycosis and VQW-765 for the treatment of acute performance anxiety in social situations; the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I in adults; the prevalence of pediatric sleep disorders; the regulatory status of Vanda’s Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for SMS in Europe and its NDA for tradipitant for the treatment of symptoms of gastroparesis in the U.S.; and Vanda’s plans to continue to support the tradipitant expanded access program for gastroparesis patients 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 correct the deficiencies identified by the FDA in the CRL with respect to the NDA for tradipitant for the treatment of symptoms of gastroparesis; Vanda’s ability to complete and submit to the FDA the NDAs for tradipitant for the treatment of motion sickness and milsaperidone for the treatments of schizophrenia and acute bipolar I disorder within the specified timeframes; the FDA’s assessment of the sufficiency of the data packages to be included in the NDAs for tradipitant and milsaperidone; Vanda’s ability to correct the deficiencies identified by the FDA in the Complete Response Letter (CRL) with respect to the sNDA for HETLIOZ® for the treatment of insomnia; the outcome in the U.S. Court of Appeals of Vanda’s challenge to the FDA’s rejection of its sNDA for HETLIOZ® for the treatment of jet lag disorder; the accuracy of the lead indicators regarding the initial market response to the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults; Vanda’s ability to initiate the Phase III programs for milsaperidone for MDD and the LAI formulation of Fanapt® by the end of 2024; the accuracy of the estimates regarding the prevalence of pediatric sleep disorders; Vanda’s ability to file the INDs for PONVORY® for the treatments of psoriasis and ulcerative colitis by the end of 2024; Vanda’s ability to initiate the Phase I study for VPO-227 for the treatment of cholera by the end of 2024; Vanda’s ability to enroll the patient for the Phase I study for VCA-894A for the treatment of CMT2S by the end of 2024; and Vanda’s ability to complete the Phase I study of VTR-297 for the treatment of onychomycosis by the end of 2024. 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
Nine Months Ended
September 30
2024
September 30
2023
September 30
2024
September 30
2023
Revenues:
Fanapt® net product sales
$ 23,919
$ 21,315
$ 67,648
$ 68,274
HETLIOZ® net product sales
17,870
17,500
56,631
79,095
PONVORY® net product sales
5,862
—
21,308
—
Total revenues
47,651
38,815
145,587
147,369
Operating expenses:
Cost of goods sold excluding amortization
2,551
3,063
8,724
11,336
Research and development
16,776
16,600
54,591
52,484
Selling, general and administrative
37,573
24,767
107,132
89,270
Intangible asset amortization
1,751
380
5,521
1,137
Total operating expenses
58,651
44,810
175,968
154,227
Loss from operations
(11,000)
(5,995)
(30,381)
(6,858)
Other income
4,756
5,875
13,957
14,858
Income (loss) before income taxes
(6,244)
(120)
(16,424)
8,000
Provision (benefit) for income taxes
(920)
(257)
(2,436)
3,091
Net income (loss)
$ (5,324)
$ 137
$ (13,988)
$ 4,909
Net income (loss) per share, basic
$ (0.09)
$ 0.00
$ (0.24)
$ 0.09
Net income (loss) per share, diluted
$ (0.09)
$ 0.00
$ (0.24)
$ 0.09
Weighted average shares outstanding, basic
58,261,961
57,519,031
58,095,566
57,329,969
Weighted average shares outstanding, diluted
58,261,961
57,595,344
58,095,566
57,512,225
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
September 30
2024
December 31
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 100,497
$ 135,821
Marketable securities
275,764
252,443
Accounts receivable, net
42,753
34,155
Inventory
1,614
1,357
Prepaid expenses and other current assets
11,759
9,170
Total current assets
432,387
432,946
Property and equipment, net
2,178
2,037
Operating lease right-of-use assets
6,016
7,103
Intangible assets, net
115,848
121,369
Deferred tax assets
79,363
75,000
Non-current inventory and other
9,323
9,985
Total assets
$ 645,115
$ 648,440
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$ 39,304
$ 38,460
Product revenue allowances
49,786
49,237
Total current liabilities
89,090
87,697
Operating lease non-current liabilities
5,486
7,006
Other non-current liabilities
9,316
8,827
Total liabilities
103,892
103,530
Stockholders’ equity:
Common stock
58
58
Additional paid-in capital
709,843
700,274
Accumulated other comprehensive income (loss)
702
(30)
Accumulated deficit
(169,380)
(155,392)
Total stockholders’ equity
541,223
544,910
Total liabilities and stockholders’ equity
$ 645,115
$ 648,440
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.
