Financial Data and Key Metrics Changes - Total revenues for Q1 2020 were $58 million, a 22% increase compared to $47.7 million in Q1 2019 [23] - Net income for Q1 2020 was $500,000 compared to a net loss of $600,000 in Q1 2019 [28] - Operating expenses in Q1 2020 were $58.1 million, up from $49.8 million in Q1 2019, driven by higher R&D and commercial expenses [28] Business Line Data and Key Metrics Changes - HETLIOZ net product sales were $35.3 million, a 22% increase from $29 million in Q1 2019 [23] - Fanapt net product sales were $22.7 million, a 21% increase from $18.8 million in Q1 2019 [27] - HETLIOZ sales decreased by 8% compared to $38.6 million in Q4 2019, while Fanapt sales were approximately flat compared to $22.3 million in Q4 2019 [25][27] Market Data and Key Metrics Changes - The specialty pharmacy channel held less than two weeks of inventory as of March 31, 2020, which was lower compared to Q4 2019 [26] - Wholesalers increased inventory on hand for Fanapt compared to Q4 2019, with a value change of approximately $200,000 [27] Company Strategy and Development Direction - The company is focused on innovating to improve patient lives and adapting sales strategies to remote models due to COVID-19 [6][10] - Vanda is pursuing new indications for HETLIOZ and has paused new clinical trial screenings while continuing treatment for existing participants [14][15] - The company is also exploring the role of Tradipitant in treating COVID-19, leveraging its expertise in the neurokinin-1 receptor system [17][37] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the company's commercial performance despite disruptions caused by the COVID-19 pandemic [11] - The company is continuously evaluating the impact of COVID-19 on its operations and will provide updates as necessary [29] - Vanda has a strong capital position with over $312 million on its balance sheet, positioning it well to pursue business strategies amid the pandemic [30] Other Important Information - The company is conducting studies related to COVID-19, including the ODYSSEY study for ARDS and the CALYPSO study on genetic variations in COVID-19 patients [17][20] - Vanda has established research partnerships to identify small molecule inhibitors for COVID-19 [21] Q&A Session Summary Question: Update on sNDA for SMS - The FDA issued a refusal to file for the sNDA, requesting additional manufacturing information and a bridge study on clinical pharmacology [33] Question: Impact of COVID on OpEx - Management does not expect a material impact on OpEx but acknowledges potential decreases in existing operating expenses due to the pandemic [34][35] Question: Rationale for Tradipitant as a COVID-19 therapy - The neurokinin-1 receptor system is involved in respiratory responses, and preclinical work suggests that Tradipitant may help modulate inflammatory responses in COVID-19 [37] Question: Oral vs. Inhaled dosing for COVID-19 study - The company has experience with oral formulations, and prior animal studies indicate that the drug can effectively reach lung tissue [41][43] Question: Enrollment for the COVID-19 trial - The company is in discussions to expand the study to additional sites as infection rates decline in New York [44]

Sales Performance - HETLIOZ® generated net sales of $143.0 million in the U.S. for the treatment of Non-24 Sleep-Wake Disorder in 2019[22]. - Fanapt® achieved net sales of $84.2 million in the U.S. for the treatment of schizophrenia in 2019[22]. Product Development and Pipeline - The company aims to maximize the commercial success of HETLIOZ® and Fanapt® while pursuing clinical development and regulatory approval for new products like tradipitant[21]. - The company has a diverse pipeline including tradipitant for atopic dermatitis and VTR-297 for hematologic malignancies[20]. - HETLIOZ® is the first FDA-approved treatment for Non-24, a disorder affecting approximately 80,000 blind individuals in the U.S.[27]. - The Phase II clinical study of tradipitant for gastroparesis met its primary endpoint, showing significant improvement in nausea scores and nausea-free days[46]. - Enrollment in the Phase III study of tradipitant in gastroparesis is ongoing, with no expected material impact from the FDA's partial clinical hold[50]. - Tradipitant was effective in treating motion sickness in a Phase II clinical study, with a higher percentage of participants in the placebo arm experiencing vomiting compared to the tradipitant arm[53]. - The company plans to file an NDA with the FDA for tradipitant in motion sickness in 2020[55]. - VTR-297, a small molecule HDAC inhibitor, is in clinical study for relapsed and/or refractory hematologic malignancies, with enrollment ongoing[56]. - The FDA accepted an IND application for VQW-765, which is being evaluated for psychiatric disorders[57]. Regulatory and Patent Information - The company has received orphan drug designation for HETLIOZ® in Non-24, providing potential financial and regulatory incentives[26]. - The NCE patent for HETLIOZ® expires in December 2022 in the U.S., with additional method of use patents expiring between 2033 and 2035[77]. - The NCE patent for tradipitant expires in April 2023, with an extension possible in the U.S. until June 2024 under Hatch-Waxman[84]. - The company has filed numerous patent applications for its products, including pending applications for VTR-297 and CFTR activators and inhibitors, addressing high unmet medical needs[87]. - The company has received an exclusive worldwide license for VQW-765, with the NCE patent expiring in 2023 in the U.S. and other markets[86]. - HETLIOZ® is protected by multiple patents, including new chemical entity and method of treatment patents, with a total of 10 patents listed in the Orange Book[76]. - Fanapt® remains protected by medicinal patents despite the expiration of its NCE patents, with 9 method of treatment patents listed[76]. Manufacturing and Supply Chain - The company relies on third-party manufacturers for drug production and distribution, with agreements in place with Patheon Pharmaceuticals for HETLIOZ® and Fanapt®[92][94]. - The manufacturing agreement for HETLIOZ® requires the company to order at least 80% of the expected yearly production from Patheon, while the agreement for Fanapt® mandates at least 70%[95][96]. Market Competition and Challenges - The pharmaceutical industry is highly competitive, with established companies having greater resources and emerging companies targeting similar markets[99]. - HETLIOZ® faces no FDA-approved direct competitors, while Fanapt® competes with several atypical antipsychotics[100]. - The FDA provides periods of regulatory exclusivity, offering three to five years of protection from new competition for approved drugs[102]. - The Orphan Drug Act allows for a seven-year exclusive marketing period for drugs treating rare diseases, providing additional benefits such as tax credits[103]. - Third-party payors increasingly challenge product pricing and may limit coverage to specific products on an approved list[130]. - Companies may need to conduct expensive pharmacoeconomic studies to demonstrate medical necessity and cost-effectiveness for reimbursement[131]. Financial Obligations and Agreements - The company is obligated to pay a 6% royalty on Fanapt® net sales in the U.S. through November 2026, with no further royalties payable after that date[64]. - The company has paid $1.2 million in upfront fees and development milestones for CFTR activators and inhibitors, with remaining milestones totaling $45.2 million, including $12.2 million for development and $33.0 million for regulatory approval and sales[70]. - The company has paid $3.0 million to Eli Lilly for tradipitant, including a $2.0 million milestone payment for Phase III study enrollment[65]. - The company has paid $37.5 million in upfront fees and milestone obligations to Bristol-Myers Squibb for the HETLIOZ® license agreement[61]. - The company entered into a license agreement with UCSF in March 2017, acquiring an exclusive worldwide license for CFTR activators and inhibitors, with total payments to UCSF amounting to $1.2 million to date, including a $1.0 million upfront fee[70]. Employee and Organizational Information - The company had 284 full-time employees as of December 31, 2019, an increase from 270 employees in the previous year[140]. - Vanda Pharmaceuticals was incorporated in 2003 and is headquartered in Washington, D.C.[19]. Strategic Focus and Goals - The company is focused on commercializing HETLIOZ® for Non-24-Hour Sleep-Wake Disorder and increasing market awareness[13]. - The company is actively seeking to identify or obtain rights to new products to expand its portfolio[14]. - The company aims to maximize the commercial success of HETLIOZ® and Fanapt® while pursuing strategic partnerships to enhance capabilities[21]. - The company is committed to securing regulatory data package protection and other proprietary rights as part of its business strategy[72].

Financial Data and Key Metrics Changes - Total revenues for the full year of 2019 were $227.2 million, an 18% increase compared to $193.1 million for 2018 [28] - Net income for 2019 was $115.6 million compared to $25.2 million for 2018, with a significant income tax benefit of $86.5 million [30] - Cash, cash equivalents, and marketable securities as of December 31, 2019, were $312.1 million, representing an increase of $54.8 million during 2019 [30] Business Line Data and Key Metrics Changes - HETLIOZ product sales for 2019 were $143 million, reflecting a 23% growth compared to 2018 [29] - Fanapt product sales for 2019 were $84.2 million, showing a 9% growth compared to 2018 [29] - In Q4 2019, HETLIOZ net product sales were $38.6 million, a 19% increase compared to $32.4 million in Q4 2018 [31] - Fanapt net product sales in Q4 2019 were $22.3 million, reflecting an 8% increase compared to $20.6 million in Q4 2018 [33] Market Data and Key Metrics Changes - The specialty pharmacy channel held less than two weeks of inventory as of December 31, 2019, with a slight increase in inventory compared to Q3 2019 [32] - Fanapt prescriptions decreased by approximately 3% in Q4 2019 compared to Q4 2018 [34] Company Strategy and Development Direction - The company plans to achieve net product sales from both HETLIOZ and Fanapt between $240 million and $260 million in 2020 [36] - HETLIOZ net product sales guidance for 2020 is between $155 million and $165 million, while Fanapt is expected to generate between $85 million and $95 million [36] - The company aims to advance commercialization efforts for HETLIOZ in the U.S. and Germany, and expand into new EU markets [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to build on growth and innovation efforts in 2020 [8] - The company anticipates that the first quarter of 2020 HETLIOZ revenue will be impacted by seasonal factors and annual payer disruptions [36] - Management expects R&D and SG&A operating expenses to rise in 2020 due to increased commercial activities and clinical programs [37] Other Important Information - The EPIONE study of tradipitant for atopic dermatitis did not meet its primary endpoint but showed significant antipruritic effects in mild patients [12][14] - The company is conducting EPIONE II and plans to reassess the study design based on the results of EPIONE [23] - The company is also advancing its pipeline products, including tradipitant for gastroparesis and motion sickness [24] Q&A Session Summary Question: What is the realistic outcome for the EPIONE study results? - Management indicated that while the primary endpoint was not met, tradipitant showed strong effects in mild atopic dermatitis patients, and the ongoing EPIONE II study could be adapted to focus on this population [47][49] Question: What updates can be provided regarding the FDA interactions? - Management confirmed ongoing discussions with the FDA regarding the necessity of additional toxicology studies and expressed optimism about identifying suitable solutions [55] Question: What is the current hypothesis on why tradipitant is effective in mild patients? - Management explained that mild atopic dermatitis may represent a distinct endotype, and the drug's mechanism may be more effective in this population due to lower levels of inflammatory mediators [76][80] Question: What is the unmet need for delayed sleep phase disorder (DSPD)? - Management noted that DSPD affects a significant portion of the population, particularly adolescents, and current treatments are limited, highlighting the potential for HETLIOZ in this area [82] Question: Will there be changes in corporate strategy following Jim Kelly's departure? - Management assured that there would be no immediate changes in corporate strategy and expressed gratitude for Jim Kelly's contributions [85]

| --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|--------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | CORPORATE | | | | | | | | | | | | | | | | | | 2019 | | | | | | | | | | PRESENTATION | November 2019 Forward-Looking Statements Various statements in this presentation, including, but not limited to, Vanda's financial guidance for 2019, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that ...

Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) Q3 2019 Earnings Conference Call November 6, 2019 4:30 PM ET Company Participants Jim Kelly – Executive Vice President and Chief Financial Officer Mihales Polymeropoulos – President and Chief Executive Officer Tim Williams – General Counsel Conference Call Participants Roger Song – Jefferies Joel Beatty – Citi Jason Butler – JMP Securities Derek Archila – Stifel Operator Ladies and gentlemen, thank you for standing by, and welcome to the Third Quarter 2019 Vanda Pha ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34186 VANDA PHARMACEUTICALS INC. (Exact name of registrant as specified in its charter) Securities regist ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34186 VANDA PHARMACEUTICALS INC. (Exact name of registrant as specified in its charter) Delaware (State or oth ...

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Q2 2019 Earnings Conference Call July 31, 2019 4:30 PM ET Company Participants James Kelly - Chief Financial Officer Mihael Polymeropoulos - President and Chief Executive Officer Conference Call Participants Roy Buchanan - JMP Securities LLC Chris Howerton - Jefferies Group LLC Joel Beatty - Citigroup Inc. Derek Archila - Stifel Financial Corp. Operator Good day, ladies and gentlemen, and welcome to Vanda Pharmaceuticals’ Second Quarter 2019 Earnings Conference call. ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34186 VANDA PHARMACEUTICALS INC. (Exact name of registrant as specified in its charter) (State or other juris ...

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Q1 2019 Results Earnings Conference Call May 1, 2019 4:30 AM ET Company Participants Jim Kelly - Executive Vice President, Chief Financial Officer, Treasurer Mihael Polymeropoulos - President and Chief Executive Officer Conference Call Participants Chris Howerton - Jefferies Joel Beatty - Citi Derek Archila - Stifel Esther Rajavelu - Oppenheimer Operator Good day ladies and gentlemen and welcome to the Vanda Pharmaceuticals' first quarter 2019 earnings conference cal ...