Charcot-Marie-Tooth disease type 2S

Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023 Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025 HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024 Tradipitant NDA for motion sickness submitted in Q4 2024 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 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 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $53.2 million in the fourth quarter of 2024, a 17% increase compared to $45.3 million in the fourth quarter of 2023 and a 12% increase compared to $47.7 million in the third quarter of 2024. Fanapt® net product sales were $26.6 million in the fourth quarter of 2024, an 18% increase compared to $22.6 million in the fourth quarter of 2023 and an 11% increase compared to $23.9 million in the third quarter of 2024. HETLIOZ® net product sales were $20.0 million in the fourth quarter of 2024, a 5% decrease compared to $21.1 million in the fourth quarter of 2023 and a 12% increase compared to $17.9 million in the third quarter of 2024. PONVORY® net product sales were $6.5 million in the fourth quarter of 2024, an increase of 11% compared to $5.9 million in the third quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. 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 and net loss of $5.3 million in the third quarter of 2024. Cash, cash equivalents and marketable securities (Cash) was $374.6 million as of December 31, 2024, representing a decrease to Cash of $1.6 million compared to September 30, 2024. Full Year 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $198.8 million for the full year 2024, a 3% increase compared to $192.6 million for the full year 2023. Fanapt® net product sales were $94.3 million for the full year 2024, a 4% increase compared to $90.9 million for the full year 2023. HETLIOZ® net product sales were $76.7 million for the full year 2024, a 23% decrease compared to $100.2 million for the full year 2023. The decrease relative to the full year 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $27.8 million for the full year 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 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. Cash was $374.6 million as of December 31, 2024, representing a decrease to Cash of $13.6 million compared to December 31, 2023. Key Operational Highlights Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the fourth quarter of 2024, as compared to the fourth quarter of 2023, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by over 160% and Fanapt® net product sales increased by 18%. Vanda initiated a Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the fourth quarter of 2024. Vanda plans to initiate a study of the Fanapt® LAI as a once-a-month injectable for the treatment of hypertension to address both treatment resistance and treatment compliance. Vanda submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the fourth quarter of 2024 for Fanapt® for bipolar I disorder and schizophrenia. Bysanti™ (milsaperidone) Vanda expects to submit a New Drug Application (NDA) for Bysanti™ to the U.S. Food and Drug Administration (FDA) for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025. Exclusivity, including pending patent applications, could extend into the 2040s. Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026. HETLIOZ® (tasimelteon) Vanda has initiated clinical programs for HETLIOZ® in pediatric insomnia and delayed sleep phase disorder (DSPD) and these programs are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome (SMS) is pending with the EMA. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of 2024. Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide), in the fourth quarter of 2024. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the NDA for tradipitant for the treatment of symptoms of gastroparesis. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab (IL-36R antagonist mAb). Vanda expects to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for generalized pustular psoriasis (GPP) for the US and EU. The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate a Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. In December 2024, Vanda announced that the FDA has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans. Key Regulatory Milestones Tradipitant NDA for motion sickness submitted in Q4 2024. Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025. Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025. 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: 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, . 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 IQVIA Prescription Data 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 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 . 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. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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WASHINGTON, Dec. 20, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2000 Americans.1 PV is a chronic myeloproliferative disorder characterized by aberrant hematopoiesis of myeloid lineage with exuberant red cell production and increased release of pro-inflammatory cytokines. More than 95% of PV patients harbor the JAK2 V617F gain-of-function mutation leading to aberrant JAK2 production.2 Inhibiting JAK2 acts to suppress hematopoiesis, consequently reducing red blood cell, neutrophil, platelet, and lymphocyte production. JAK2 inhibitors have been shown to be efficacious in treating various JAK-dependent hematologic malignancies, including the treatment of PV. By selective reduction of JAK2 levels, the ASO VGT-1849A has the potential to reduce JAK2V617F-driven pathogenic signaling, ultimately suppressing the malignant proliferation and survival of hematopoietic cells. Currently available small molecule inhibitors targeting the JAK2 protein kinase, such as Jakafi®, Inrebic®, Ojjaara®, and Vonjo®, lack sole selectivity for the target protein, which can result in off target effects. The adverse side effects that may occur from JAK inhibition emphasize the importance of selectively targeting JAK2 while avoiding inhibition of other JAK family members. By specifically targeting JAK2, Vanda seeks to reduce the risk of infection and toxic effects that are seen with inhibitors also blocking JAK1, JAK3, TYK2, or other kinases outside of the JAK family. If approved, VGT-1849A could offer targeted efficacy with an improved safety profile and convenient dosing. "This orphan designation for VGT-1849A is an important milestone in precision medicine-based therapeutics in the space of hematological malignancies. This milestone marks the second precision medicine therapeutic for Vanda following the development of VCA-894A for Charcot-Marie-Tooth3 that is expected to begin clinical testing in the coming months," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. VGT-1849A is a novel ASO treatment candidate for PV and other JAK2-driven hematologic malignancies. By selectively targeting JAK2, VGT-1849A reduces downstream signaling and JAK2V617F-driven autonomous cell proliferation, without any off-target kinase effects. The ability of VGT-1849A to reduce JAK2 activity may alleviate the disease burden that patients with PV face with a favorable safety profile, resulting in a higher quality of life for patients. Orphan Drug Designation is granted by the FDA to investigational therapies addressing rare medical conditions and provides benefits to drug developers. References: Grunwald, M. R.; Stein, B. L.; Boccia, R. V.; Oh, S. T.; Paranagama, D.; Parasuraman, S.; Colucci, P.; Mesa, R. Clinical and Disease Characteristics From REVEAL at Time of Enrollment (Baseline): Prospective Observational Study of Patients With Polycythemia Vera in the United States. Clin Lymphoma Myeloma Leuk 2018, 18 (12), 788-795.e2. . P. Gou, W. Zhang, and S. Giraudier, "Insights into the Potential Mechanisms of JAK2V617F Somatic Mutation Contributing Distinct Phenotypes in Myeloproliferative Neoplasms," Myeloproliferative Neoplasms. Int. J. Mol. Sci, vol. 2022, p. 1013, 2022, S. Smieszek, C. Tyner, A. Kaden, C. Johnson, C. Polymeropoulos, G. Birznieks, M. Polymeropoulos. Potential treatment for CMT2S caused by IGHMBP2 cryptic splice variant, with ASO based therapeutic [abstract]. Mov Disord. 2023; 38 (suppl 1). . 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 and follow us on X @vandapharma. About VGT-1849A VGT-1849A is an antisense oligonucleotide (ASO) that selectively targets JAK2, reducing increased activity of JAK2 that may cause hematologic malignancies. ASOs have broad applicability in addressing a number of disorders caused by genetic variants. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this press release, including, but not limited to statements regarding the estimated prevalence of PV, the potential therapeutic effects of VGT-1849A, the timing of the initiation of clinical testing of VCA-894A and the potential benefits of VGT-1849A, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the accuracy of the reporting and diagnosis of PV cases, the ability of VGT-1849A to safely and effectively treat PV, Vanda's ability to begin clinical testing of VCA-894A during the specified timeframe and Vanda's ability to successfully complete the clinical development of, and obtain regulatory approval for, VGT-1849A in the treatment of PV. There can be no assurance that the actual 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. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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 . 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. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges Fanapt® launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 Fanapt® long acting injectable program expected to be initiated in Q4 2024 Milsaperidone NDA for schizophrenia and bipolar I disorder expected to be submitted in early 2025; initiation of major depressive disorder program expected in Q4 2024 PONVORY® commercial launch for multiple sclerosis initiated in Q3 2024 PONVORY® IND applications for psoriasis and ulcerative colitis expected to be submitted in Q4 2024 Tradipitant NDA for motion sickness expected to be submitted in Q4 2024 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 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $47.7 million in the third quarter of 2024, a 23% increase compared to $38.8 million in the third quarter of 2023. Fanapt® net product sales were $23.9 million in the third quarter of 2024, a 12% increase compared to $21.3 million in the third quarter of 2023. HETLIOZ® net product sales were $17.9 million in the third quarter of 2024, a 2% increase compared to $17.5 million in the third quarter of 2023. PONVORY® net product sales were $5.9 million in the third quarter of 2024, a decrease of 32% compared to $8.6 million in the second quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. 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. Cash, cash equivalents and marketable securities (Cash) was $376.3 million as of September 30, 2024, representing a decrease to Cash of $11.4 million compared to June 30, 2024. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. First Nine Months of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $145.6 million in the first nine months of 2024, a 1% decrease compared to $147.4 million in the first nine months of 2023. Fanapt® net product sales were $67.6 million in the first nine months of 2024, a 1% decrease compared to $68.3 million in the first nine months of 2023. HETLIOZ® net product sales were $56.6 million in the first nine months of 2024, a 28% decrease compared to $79.1 million in the first nine months of 2023. The decrease relative to the first nine months of 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $21.3 million in the first nine months of 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 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. Cash was $376.3 million as of September 30, 2024, representing a decrease to Cash of $12.0 million compared to December 31, 2023. The Cash balance of $376.3 million as of September 30, 2024 does not include a payment from Janssen for $8.1 million primarily related to second quarter 2024 PONVORY® revenue receivables, which was received in the fourth quarter of 2024. Key Operational Highlights Psychiatry Portfolio Fanapt® (iloperidone): Vanda initiated the commercial launch of Fanapt® for the acute treatment of bipolar I disorder in adults in the third quarter of 2024, which included the expansion of its existing sales force and the introduction of prescriber awareness and comprehensive marketing programs. Several lead indicators suggest a strong initial market response including new patient starts as reflected by new to brand prescriptions (NBRx),1 increasing by over 90% in the third quarter of 2024 as compared to the third quarter of 2023. Milsaperidone: Vanda expects to submit a New Drug Application (NDA) for milsaperidone (also known as VHX-896 and P-88), the active metabolite of Fanapt®, for the treatments of schizophrenia and acute bipolar I disorder to the U.S. Food and Drug Administration (FDA) in early 2025. Vanda expects to initiate a Phase III program for milsaperidone for major depressive disorder (MDD) by the end of 2024. Iloperidone long acting injectable (LAI): Vanda expects to initiate a Phase III program for the LAI formulation of Fanapt® in the fourth quarter of 2024. HETLIOZ® (tasimelteon) Vanda has initiated a HETLIOZ LQ® program in pediatric insomnia. Although the prevalence of insomnia in children is difficult to determine, it is estimated that 20-40% of children experience significant sleep problems.2,3 There are currently no approved treatments for pediatric insomnia. Vanda continues to pursue FDA approval for HETLIOZ® for the treatments of jet lag disorder and insomnia. Vanda is challenging the FDA's rejection of Vanda's supplemental New Drug Application (sNDA) for the treatment of jet lag disorder in the U.S. Court of Appeals for the D.C. Circuit. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the insomnia sNDA. Vanda's litigation asserting HETLIOZ® Patent No. 11,285,129 against generic manufacturers is currently pending in the U.S. District Court for the District of Delaware. A jury trial has been scheduled for the first quarter of 2026. European Medicines Agency action on Vanda's Marketing Authorization Application for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome is expected in the first quarter of 2025. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024, which included the deployment of a specialty sales force. Vanda expects Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis to be completed in the fourth quarter of 2024. Tradipitant Gastroparesis NDA: In September 2024, the FDA declined to approve Vanda's NDA for tradipitant for the treatment of symptoms of gastroparesis. Vanda plans to continue to pursue the marketing authorization for tradipitant and support the expanded access program that is currently serving several dozen patients with gastroparesis. Motion Sickness NDA: Vanda expects to submit an NDA for tradipitant for the treatment of motion sickness to the FDA in the fourth quarter of 2024. The NDA for the treatment of motion sickness is expected to include the positive results of three placebo controlled clinical studies where tradipitant was effective in preventing vomiting associated with motion. Vanda plans to initiate a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog (semaglutide) in the fourth quarter of 2024. Early-Stage Programs Vanda plans to proceed with studies of VSJ-110, a CFTR activator, for the treatment of dry eye disorder. An ongoing proof of concept study indicates an effect in improving the signs (fluorescein corneal staining) of dry eye disease. VPO-227, a CFTR inhibitor for the treatment of cholera, has received approval to proceed in a Phase I study in Bangladesh, a country where the treatment of cholera remains a significant and unmet need. Vanda plans to initiate this study by the end of 2024. The Phase I clinical study for 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, expects to enroll the patient by the end of 2024. The Phase I clinical study for VTR-297 for the treatment of onychomycosis, a fungal infection of the nail, was initiated in April 2024. The study is fully enrolled, and results are expected by the end of 2024. VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. 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: 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, . 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 IQVIA Prescription Data Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, Liao D, Bixler EO. Prevalence of insomnia symptoms in a general population sample of young children and preadolescents: gender effects. Sleep Med. 2014 Jan;15(1):91-5. doi: 10.1016/j.sleep.2013.08.787. Epub 2013 Oct 16. PMID: 24333223; PMCID: PMC3912735. Fricke-Oerkermann L, Plück J, Schredl M, Heinz K, Mitschke A, Wiater A, Lehmkuhl G. Prevalence and course of sleep problems in childhood. Sleep. 2007 Oct;30(10):1371-7. doi: 10.1093/sleep/30.10.1371. PMID: 17969471; PMCID: PMC2266270. 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 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 . 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. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc. 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