Q2 2024 Vanda Pharmaceuticals Inc Earnings Call

Thank you for standing by. My name is Meg and I will be your conference operator today.

Operator: At this time, I would like to welcome everyone to the Q2 2024 Vanda Pharmaceuticals Inc. Earnings Conference Call. All lines have been placed on mute to prevent any background noise.

Speaker Change: At this time, I would like to welcome everyone to the Q2 2024 Vanda Pharmaceuticals Inc Earnings Conference Call.

Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to rephrase your question, press star one again. Thank you. I would now like to turn the conference over to Mr. Kevin Moran, Vanda's Chief Financial Officer. You may begin.

Speaker Change: All lines have been placed on mute to prevent any background noise.

Speaker Change: After the speaker's remarks, there will be a question and answer session.

Speaker Change: If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad.

Speaker Change: If you would like to redraw your question, press star one again. Thank you. I would now like to turn the conference over to Mr. Kevin Moran, Vanda's Chief Financial Officer. You may begin.

Kevin Patrick Moran: Thank you, Meg. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' second quarter 2024 performance. Our second quarter 2024 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website. Joining me on today's call is Dr. Mihael Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board, and Tim Williams, our General Counsel.

Kevin Patrick Moran: Thank you, Meg. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' second quarter 2024 performance.

Kevin Patrick Moran: Our second quarter of 2024 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com.

Speaker Change: In addition, we are providing live and archived versions of this conference call on our website. Joining me on today's call is Dr. Mihael Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board, and Tim Williams, our General Counsel.

Kevin Patrick Moran: Following my introductory remarks, Mahalos will update you on our ongoing activities, and I will then comment on our financial results before we open the lines for your questions. Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainty.

Speaker Change: Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions.

Speaker Change: Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainties.

Kevin Patrick Moran: These risks are described 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 our most recent annual report on Form 10-K, as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K, and other filings with the SEC, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other filings.

Speaker Change: These risks are described in the Cautionary Note regarding forward-looking statements.

Speaker Change: Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations

Speaker Change: Sections of our most recent annual report on Form 10-K , as updated by our subsequent quarterly reports on Form 10-Q , current reports on Form 8-K, and other filings with the SEC, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other filings.

Kevin Patrick Moran: The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events, or otherwise, except as required by law. With that said, I would now like to turn the call over to our CEO, Dr. Mihael Polymeropoulos.

Speaker Change: The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events, or otherwise, except as required by law. With that said, I would now like to turn the call over to our CEO , Dr. Mihael Polymeropoulos.

Mihael H. Polymeropoulos: Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's second quarter 2024 results. The beginning of the quarter was marked with a significant milestone, the FDA approval of FNAP for the treatment of bipolar 1 disorder. This approval expands the commercial potential of FANAP and lays down the foundation for our psychiatric portfolio. As a result of this development, we focused our operational efforts on expanding and strengthening our commercial organization to better position us to maximize the commercial value of the asset.

Speaker Change: Thank you very much, Kevin, and good afternoon, everyone.

Speaker Change: Thank you for joining us to discuss Vanda's second quarter 2024 results.

Speaker Change: The beginning of the quarter was marked with a significant milestone of the FDA approval of FNAP for the treatment of Bipolar 1 disorder.

Speaker Change: This approval expands the commercial potential of FANAP and lays down the foundation for our psychiatry portfolio.

Speaker Change: As a result of this development, we focused our operational efforts in expanding and strengthening our commercial organization to better position us to maximize the commercial value of the asset.

Mihael H. Polymeropoulos: In a short period of time, we have increased by three times the size of our sales force, significantly expanded our FNAP speaker program, and begun engaging with prescribers. In addition, we're building our marketing campaign, and we expect to reach full operational capacity in the fourth quarter of this year. In addition to these commercial efforts, the clinical development of the psychiatry portfolio, with a new drug application filing expected in early 2025 for milsapiridone, an active metabolite of FANAPT, for the treatment of bipolar disorder and schizophrenia.

Speaker Change: In a short period of time, we have increased by three times the size of our sales force, significantly expanded our FNAP speakers program, and began engaging with prescribers.

Speaker Change: In addition, we're building our marketing campaign and we expect to reach full operational capacity in the fourth quarter of this year.

Speaker Change: In addition to these commercial efforts, the clinical development of the psychiatry portfolio is advancing.

Speaker Change: with a new drug application filing expected in early 2025 for milsapiridone, an active metabolite of FANAPT, for the treatment of bipolar disorder and schizophrenia.

Mihael H. Polymeropoulos: We're also preparing to initiate the clinical program in major depression with Milsa Peridon in the fourth quarter of this year. The long-acting injectable program of alloperidone is continuing, with the expected initiation of the phase 3 study for the maintenance of treatment in schizophrenia later this year.

Speaker Change: We are also preparing to initiate the clinical program in major depression with milsapiridone in the fourth quarter of this year.

Speaker Change: The long-acting injectable program of alloperidone is continuing with the expected initiation of the Phase III study for the maintenance of treatment in schizophrenia later this year.

Mihael H. Polymeropoulos: We're excited with the prospects of our psychiatry franchise, which we expect to provide significant value to patients and provide Vanda with significant revenue growth well into the future. With the acquisition of Ponvori from Janssen and the full transfer of ownership to Vanda, we have also focused on building a commercial organization to promote Ponvori in the treatment of multiple sclerosis. We are now close to completing the hiring of a new specialty sales force and initiating patient support and marketing activities in the near future.

Speaker Change: We're excited with the prospects of our psychiatry franchise that we expect to provide significant value to patients and provide Vanda with significant revenue growth well into the future.

Speaker Change: With the acquisition of Ponvori from Janssen and the full transfer of ownership to Vanda, we have also focused in building a commercial organization to promote Ponvori in the treatment of multiple sclerosis.

Speaker Change: We're now close to completing the hiring of a new specialty sales force and initiating patient support and marketing activities in the near future.

Mihael H. Polymeropoulos: We believe that PUNVORI provides a useful and competitive option among disease-modifying treatment modalities for patients with multiple sclerosis. We're confident that increasing awareness among prescribers and patients will be able to further drive utilization and allow for a return to revenue growth in the near future. We're also working towards initiating clinical programs in psoriasis and ulcerative colitis, where Ponvori can become a significant treatment option as a once-a-day oral medication with a quick onset of action, as well as quick reversibility of its immune regulatory effects.

Speaker Change: We believe that Punvori provides a useful and competitive option among the disease-modifying treatment modalities for patients with multiple sclerosis.

Speaker Change: We're confident that increasing awareness among prescribers and patients will be able to further drive utilization and allow for a return to revenue growth in the near future.

Speaker Change: We're also working towards initiating clinical programs

Speaker Change: in psoriasis and ulcerative colitis where Ponvori can become a significant treatment option as a once a day oral medication with quick onset of action as well as quick reversibility of its immune regulatory effect.

Mihael H. Polymeropoulos: Our third commercial product, Hetlio's Oral Capsules for Non-24-Hour Sleep-Wake Disorder, continues to face revenue erosion due to the introduction of genetic products. Nonetheless, space and loyalty to our quality product have allowed us to maintain a significant market share in the space and population.

Speaker Change: Our third commercial product, Hetlio's Oral Capsules for Non-24-Hour Sleep-Wake Disorder, continues to face revenue erosion due to the introduction of genetic products.

Speaker Change: Nonetheless, patient loyalty to our quality product has allowed us to maintain a significant market share in this patient population.

Mihael H. Polymeropoulos: Hetlios-LQ, approved for children with Smith-McGinnis syndrome, is not affected by genetic competition and continues to serve the Smith-McGinnis syndrome community. We have recently applied for marketing authorization in the EMA for both Hetlios and Hetlios-LQ for Smith-McGannis syndrome. Headless is currently approved for non-24 in the European Union and is actively commercialized in Germany.

Speaker Change: Hetlios LQ, approved for children with Smith-McGinnis syndrome, is not affected by genetics competition and continues to serve the Smith-McGinnis syndrome community.

Speaker Change: We have recently applied for marketing authorization in the EMA for both Hetlios and Hetlios LQ for Smith-McGinnis syndrome.

Speaker Change: Hetlios is currently approved for non-24 in the European Union and is actively commercialized in Germany.

Mihael H. Polymeropoulos: Ketlius is not facing generic competition in the EU at this time. In addition to our commercial efforts, HETVUS is under development for delayed sleep-wake phase disorder, and HETVUS-LQ is under development for the treatment of pediatric insomnia. Both disorders currently have no FDA-approved treatments and represent a significant unmet medical need. I will turn to our portfolio of assets under development and offer some highlights.

Speaker Change: Hetlios is not facing generic competition in the EU at this time.

Speaker Change: In addition to our commercial efforts, HETLUS is under development for delayed sleep-wake phase disorder, and HETLUS-LQ is under development for the treatment of pediatric insomnia.

Speaker Change: Both disorders have currently no FDA approved treatments and represent a significant unmet medical need.

Speaker Change: I will turn to our portfolio of assets under development and offer some highlights.

Mihael H. Polymeropoulos: The new drug application for tridipetan for the treatment of syndromes of gastroparesis remains under review by the FDA with a PDUFA target action date of September 18, 2024. We continue to believe that the evidence provided in the NDA, including from qualified experts, constitutes both substantial evidence of efficacy and sufficient safety information to support the approval of tradiptin to treat the symptoms of gastroparesis. We believe that the agency should convene an advisory committee to assist in reviewing this application with experts in the field, given the novelty of the mechanism of action pursued for this indication and the lack of approval of any drug in this indication for over 40 years.

Speaker Change: The new drug application for tridipetan for the treatment of syndromes of gastroparesis remains under review by the FDA with a PDUFA target action date of September 18, 2024.

Speaker Change: We continue to believe that the evidence provided in the NDA, including from qualified experts,

Speaker Change: constitutes both substantial evidence of efficacy

Speaker Change: sufficient safety information to support the approval of tradiptin to treat the symptoms of gastroparesis.

Speaker Change: We believe that the agency should convene an advisory committee to assist in reviewing this application with experts in the field.

Speaker Change: given the novelty of the mechanism of action pursued for this indication and the lack of approval of any drug in this indication in over 40 years.

Mihael H. Polymeropoulos: However, despite our repeated requests for an advisory committee meeting to consider the NDA, the FDA has yet to grant one. At a late-cycle meeting held in June, the FDA stated that it would take into consideration our request for an advisory committee meeting. We have followed up on this request several times, but have yet to receive a response.

Speaker Change: However, despite our repeated requests for an advisory committee meeting to consider the NDA, the FDA has yet to grant one.

Speaker Change: In a late cycle meeting held in June , the FDA stated that it would take into consideration our request for an advisory committee meeting. We have followed up on this request several times but have yet to receive a response.

Mihael H. Polymeropoulos: On May 31st, we received a discipline review letter in which, among other comments, the FDA provided a preliminary notice that they had identified deficiencies that preclude discussion of labeling and post-marketing requirements and commitments, but that their comments do not reflect a final decision on the information reviewed and should not be construed as such. We requested clarification from the FDA as to whether we should expect labeling communication prior to the PDUFA date, but the FDA has yet to respond.

Speaker Change: On May 31st, we received a Discipline Review Letter in which, among other comments, the FDA provided a preliminary notice that they had identified deficiencies.

Speaker Change: that preclude discussion of labeling and post-marketing requirements and commitments.

Speaker Change: but that their comments do not reflect a final decision on the information reviewed and should not be construed to do so.

Speaker Change: We requested clarification from the FDA as to whether we should expect labeling communication prior to the PDUFA date, but the FDA has yet to respond.

Mihael H. Polymeropoulos: Nonetheless, we remain confident in the body of evidence we have presented, and we await clarity on next steps by the FDA. On tridipetam again, in the second quarter, we reported positive results for our second phase 3 study, emotion sickness, completing, therefore, our clinical efficacy package with two positive phase 3 studies and supporting positive phase two studies. The studies were conducted under real-world conditions in the coastal waters of the United States.

Speaker Change: Nonetheless, we remain confident in the body of evidence we have presented and we await clarity on next steps by the FDA.

Speaker Change: On tradipitin again, in the second quarter, we reported on positive results for our second phase 3 study in motion sickness.

Speaker Change: Completing, therefore, our clinical efficacy package with two positive Phase III studies and supporting positive Phase II studies.

Speaker Change: The studies were conducted under real-world conditions in the coastal water of the United States.

Kevin Patrick Moran: We plan to seek FDA approval for its use in the prevention of vomiting in motion sickness later this year. With that, I'll now turn the call back to Kevin Moran to discuss our financial results. Thank you, Mihael.

Speaker Change: We plan to seek FDA approval for tridipydine in the prevention of vomiting in motion sickness later this year.

Speaker Change: With that, I'll turn now the call back to Kevin Moran to discuss our financial results. Kevin.

Kevin Patrick Moran: I will begin by summarizing our financial results for the first six months of 2024 before turning to discuss the second quarter of 2024. Total revenues for the first six months of 2024 were $97.9 million, a 10% decrease compared to $108.6 million for the same period in 2023. This decrease was primarily due to the launch of generic versions of Hetlios, which we have discussed in some detail, partially offset by the introduction of Ponvori revenue following our acquisition of the product in December of 2023.

Kevin Patrick Moran: Thank you, Myles. I will begin by summarizing our financial results for the first six months of 2024 before turning to discuss the second quarter of 2024.

Kevin Patrick Moran: Total revenues for the first six months of 2024 were $97.9 million, a 10% decrease compared to $108.6 million for the same period in 2023.

Kevin Patrick Moran: This decrease was primarily due to the launch of generic versions of Hetlios, which we have discussed in some detail, partially offset by the introduction of Pomvori revenue following our acquisition of the product in December of 2023.

Kevin Patrick Moran: FNAP net product sales were $43.7 million for the first six months of 2024, a 7% decrease compared to $47 million for the same period in 2023. This decrease in net product sales relative to the first six months of 2023 was attributable to a decrease in volume, turning to Hetlios. Hetlio's net product sales were $38.8 million for the first six months of 2024, a 37% decrease compared to $61.6 million for the same period in 2023. The decrease in net product sales relative to the first six months of 2023 was attributable to a decrease in volume, partially offset by an increase in price net of deduction.

Kevin Patrick Moran: FNAF net product sales were $43.7 million for the first six months of 2024, a 7% decrease compared to $47 million in the same period in 2023. This decrease to net product sales relative to the first six months of 2023 was attributable to a decrease in volume.

Kevin Patrick Moran: Turning to HETLios.

Kevin Patrick Moran: Hetlio's net product sales were $38.8 million for the first six months of 2024, a 37% decrease compared to $61.6 million in the same period in 2023.

Kevin Patrick Moran: The decrease to net product sales relative to the first six months of 2023 was attributable to a decrease in volume partially offset by an increase in price net of deductions.

Kevin Patrick Moran: Hetlios Net Product Sales, as reported for the first quarter of 2023, reflected higher unit sales as compared to recent prior periods. The higher unit sales during the first quarter of 2023 resulted in a significant increase in inventory stocking at specialty pharmacy customers at March 31st, 2023. During the remainder of 2023, although there was continued destocking at specialty pharmacy customers, inventory levels at December 31st, 2023 remained elevated relative to inventory levels prior to the entrance of generic competition and continued to remain elevated at March 31st, 2024 and June 30th, 2024.

Kevin Patrick Moran: Hetlio's net product sales, as reported for the first quarter of 2023, reflected higher unit sales as compared to recent prior periods.

Kevin Patrick Moran: The higher unit sales during the first quarter of 2023 resulted in a significant increase of inventory stocking at specialty pharmacy customers at March 31st, 2023.

Kevin Patrick Moran: During the remainder of 2023, although there was continued de-stocking of specialty pharmacy customers,

Kevin Patrick Moran: Inventory levels at December 31st, 2023 remained elevated relative to inventory levels prior to the entrance of generic competition and continue to remain elevated at March 31st, 2024 and June 30th, 2024.

Kevin Patrick Moran: Going forward, Hetlios Net Product Sales may reflect lower unit sales as a result of the reduction of elevated inventory levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, Hetlios Net product sales will likely decline in future periods, potentially significantly, as a result of continued generic competition in the U.S. Ponvori net product sales were $15.4 million for the first six months of 2024. As a reminder, we completed the acquisition of the U.S. and Canadian rights to Ponvori in December of 2023.

Kevin Patrick Moran: Going forward, Hetlios Net Product Sales may reflect lower unit sales as a result of the reduction of elevated inventory levels at Specialty Pharmacy customers, or may be variable depending on when Specialty Pharmacy customers need to purchase again.

Kevin Patrick Moran: Further, Helios Net product sales will likely decline in future periods, potentially significantly, related to continued generic competition in the U.S.

Kevin Patrick Moran: and finally turning to Ponvori.

Kevin Patrick Moran: Pinvori Net Product Sales were $15.4 million for the first six months of 2024.

Kevin Patrick Moran: As a reminder, we completed the acquisition of the U.S. and Canadian rights to Ponbori in December of 2023. As such, this represents the second full quarter of Ponbori revenue recognition at Vanda, and a positive step in diversifying our product mix with innovative and value-generating products.

Kevin Patrick Moran: As such, this represents the second full quarter of Ponvori revenue recognition at Vanda and a positive step in diversifying our product mix with innovative and value-generating products. For the first six months of 2024, Vanda recorded a net loss of $8.7 million compared to a net income of $4.8 million for the same period in 2023. The net loss for the first six months of 2024 included an income tax benefit of $1.5 million as compared to an income tax provision of $3.3 million for the same period in 2023.

Kevin Patrick Moran: For the first six months of 2024, Vanda recorded a net loss of $8.7 million compared to net income of $4.8 million for the same period in 2023. The net loss for the first six months of 2024 included an income tax benefit of $1.5 million as compared to an income tax provision of $3.3 million for the same period in 2023.

Kevin Patrick Moran: Operating expenses for the first six months of 2024 were $117.3 million, compared to $109.4 million for the same period in 2023. The $7.9 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Phenaptin Bipolar Disorder and Ponvorium Multiple Sclerosis and legal and other corporate activities, as well as higher intangible asset amortization expense due to the amortization recorded on the Ponvorium intangible asset.

Kevin Patrick Moran: Operating expenses for the first six months of 2024 were $117.3 million compared to $109.4 million for the same period in 2023.

Kevin Patrick Moran: The $7.9 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Phenaptin Bipolar Disorder and Ponvoria Multiple Sclerosis and legal and other corporate activities, as well as higher intangible asset amortization expense due to the amortization recorded on the Ponvoria Intangible Asset.

Kevin Patrick Moran: During the first half of 2024, we commenced a host of activities in anticipation of our commercial launches of Phenaptin Pomvori, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. SG&A expenses may increase in future periods as a result of the ongoing commercial launches of FANAPTA and POMVORI, which were initiated in the third quarter of 2024. Vanda's cash, cash equivalents, and marketable securities, referred to as cash, as of June 30, 2024, were $387.7 million, representing a decrease of $0.6 million compared to December 31, 2023 and a decrease of $6.5 million compared to March 31, 2024.

Kevin Patrick Moran: During the first half of 2024, we commenced a host of activities in anticipation of our commercial launches of Phenaptin Pomvori, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs.

Kevin Patrick Moran: SG&A expenses may increase in future periods as a result of the ongoing commercial launches of FNAP and Pomvori, which were initiated in the third quarter of 2024.

Kevin Patrick Moran: Vanda's cash, cash equivalents, and marketable securities, referred to as cash, as of June 30, 2024, were $387.7 million, representing a decrease of $0.6 million compared to December 31, 2023, and a decrease of $6.5 million compared to March 31, 2024.

Kevin Patrick Moran: The change in cash during the second quarter of 2024, as compared to the first quarter of 2024, was driven by the timing of cash in from customers for revenue and related payments of rebates to payers as compared to recent prior periods. Turning now to our quarterly results.

Kevin Patrick Moran: The change in cash during the second quarter of 2024, as compared to the first quarter of 2024, was driven by the timing of cash in from customers for revenue and related payments of rebates to payers as compared to recent prior periods.

Kevin Patrick Moran: Total revenues for the second quarter of 2024 were $50.5 million, a 10 percent increase compared to $46.1 million for the second quarter of 2023 and a 6 percent increase compared to $47.5 million in the first quarter of 2024. The increase as compared to the second quarter of 2023 was primarily due to the introduction of Pomvori revenue following our acquisition of the product in December 2023, partially offset by decreased Hetlios revenue due to the launch of generic versions of Hetlios.

Speaker Change: Turning now to our quarterly results.

Speaker Change: Total revenues for the second quarter of 2024 were $50.5 million, a 10% increase compared to $46.1 million for the second quarter of 2023, and a 6% increase compared to $47.5 million in the first quarter of 2024.

Speaker Change: The increase as compared to the second quarter of 2023 was primarily due to the introduction of POMBORI revenue following our acquisition of the product in December 2023, partially offset by decreased HETLIAS revenue due to the launch of generic versions of HETLIAS.

Kevin Patrick Moran: FNAP net product sales were $23.2 million for the second quarter of 2024, a 4% decrease compared to $24.1 million in the second quarter of 2023. FNAP net product sales in the second quarter of 2024 increased by 12% as compared to $20.6 million in the first quarter of 2024. The increase in net product sales relative to the first quarter of 2024 was attributable to an increase in volume. FNAP prescriptions in the second quarter of 2024, as reported by Equivia Exponent, increased by approximately 2% compared to the first quarter of 2024. Turning to Hathio's,

Speaker Change: FNAP net product sales were $23.2 million for the second quarter of 2024, a 4% decrease compared to $24.1 million in the second quarter of 2023.

Speaker Change: The net product sales in the second quarter of 2024 increased by 12% as compared to $20.6 million in the first quarter of 2024. The increase to net product sales relative to the first quarter of 2024 was attributable to an increase in volume.

Speaker Change: FNAP prescriptions in the second quarter of 2024, as reported by Equiva Exponent, increased by approximately 2% compared to the first quarter of 2024.

Kevin Patrick Moran: Hetlios net product sales were $18.7 million for the second quarter of 2024, a 15% decrease compared to $22 million in the second quarter of 2023. The decrease in net product sales relative to the second quarter of 2023 was attributable to a decrease in price net of deduction. Hetlio's net product sales in the second quarter decreased by 7% as compared to $20.1 million in the first quarter of 2024. The decrease in net product sales relative to the first quarter of 2024 was attributable to a decrease in volume partially offset by an increase in price net of deduction. And finally, turning to the POMP Board.

Speaker Change: Turning to HETLios.

Speaker Change: Hetlio's net product sales were $18.7 million for the second quarter of 2024, a 15% decrease compared to $22 million in the second quarter of 2023. The decrease to net product sales relative to the second quarter of 2023 was attributable to a decrease in price net of deductions.

Speaker Change: Hetlios net product sales in the second quarter decreased by 7% as compared to $20.1 million in the first quarter of 2024. The decrease in net product sales relative to the first quarter of 2024 was attributable to a decrease in volume, partially offset by an increase in price net of deductions.

Kevin Patrick Moran: Pombori net product sales were $8.6 million for the second quarter of 2024, an increase of 26% compared to $6.8 million in the first quarter of 2024. The increase in net product sales was attributable to an increase in price net of deductions, partially offset by a decrease in volume. As a reminder, we completed the acquisition of the U.S. and Canadian rights to Ponvoree in December of 2023. For the second quarter of 2024, Vanda recorded a net loss of $4.5 million compared to a net income of $1.5 million for the second quarter of 2023. The net loss for the second quarter of 2024 included an income tax benefit of $1 million as compared to an income tax provision of $1.1 million for the second quarter of 2023.

Speaker Change: And finally, turning to POM-40.

Speaker Change: Pombori Net Product Sales were $8.6 million for the second quarter of 2024, an increase of 26% compared to $6.8 million in the first quarter of 2024.

Speaker Change: The increase in net product sales was attributable to an increase in price net of deductions, partially offset by a decrease in volume. As a reminder, we completed the acquisition of the U.S. and Canadian Rights Pond Vory in December of 2023.

Vander: For the second quarter of 2024, Vanda recorded a net loss of $4.5 million, compared to a net income of $1.5 million for the second quarter of 2023. The net loss for the second quarter of 2024 included an income tax benefit of $1 million, as compared to an income tax provision of $1.1 million for the second quarter of 2023.

Kevin Patrick Moran: Operating expenses in the second quarter of 2024 were $60.6 million, compared to $48.9 million in the second quarter of 2023. The $11.7 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of FNAF and POMPORY, as well as legal and other corporate activities. Operating expenses in the second quarter of 2024 increased by $3.9 million as compared to $56.7 million in the first quarter of 2024.

Vander: Operating expenses in the second quarter of 2024 were $60.6 million compared to $48.9 million in the second quarter of 2023.

Vander: The $11.7 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Phanaptom Pomvori and legal and other corporate activities.

Vander: Operating expenses in the second quarter of 2024 increased by $3.9 million as compared to $56.7 million in the first quarter of 2024.

Kevin Patrick Moran: This increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of FNAP and Pombori, and legal and other corporate activities, partially offset by a decrease in R&D spend related to lower expenses on the Tridipinant Development Program. During the first half of 2024, we commenced a host of activities in anticipation of our commercial launches of Fanaptin Bipolar Disorder and Pumboria Multiple Sclerosis, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs.

Vander: This increase is primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of FNAP and POMBORI, and legal and other corporate activities, partially offset by a decrease in R&D spend related to lower expenses on the Tridipinant Development Program.

Vander: During the first half of 2024, we commenced a host of activities in anticipation of our commercial launches of Phenaptin Bipolar Disorder and Pumboria Multiple Sclerosis, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs.

Kevin Patrick Moran: SG&E expenses may increase in future periods as a result of the ongoing commercial launches of Phenaptin pump worry, which were initiated in the third quarter of 2024. With regard to the launches of Phenaptin Bipolar Disorder and Pomborin Multiple Sclerosis, as I mentioned, the launches were initiated in the third quarter, and we expect our full commercial infrastructure to be in place by the end of this year, with the impact of these commercial efforts expected to begin to impact revenue later this year. We have already seen tremendous progress in our commercial activities.

Vander: SG&E expenses may increase in future periods as a result of the ongoing commercial launches of Phenaptin pump worry, which again were initiated in the third quarter of 2024.

Vander: With regards to the launches of Phenaptin Bipolar Disorder and Pomphorium Multiple Sclerosis, as I mentioned, the launches were initiated in the third quarter and we expect our full commercial infrastructure to be in place by the end of this year, with the impact of these commercial efforts expected to begin to impact revenue later this year.

Kevin Patrick Moran: As Mahalis mentioned, our overall sales force size as of today is approximately three times larger as compared to the end of the first quarter of 2024. Additionally, the number of FNAP prescriber awareness programs scheduled to be completed in the third quarter of 2024 is more than three times larger than the number of programs completed in the second quarter of 2024. The expansion has allowed us to significantly increase our reach and frequency with prescribers, and early indicators of new FNAP starts per IQIBIA data appear positive.

Vander: We have already seen tremendous progress on our commercial activities. As Mahalis mentioned, our overall sales force size as of today is approximately three times larger as compared to the end of the first quarter of 2024.

Mahalis: The number of FNAP prescriber awareness programs scheduled to be completed in the third quarter of 2024 is more than three times larger than the number of programs completed in the second quarter of 2024.

Mahalis: The expansion has allowed us to significantly increase our reach and frequency with prescribers, and early indicators of new FNAP starts per IQIVIA data appear positive.

Kevin Patrick Moran: Turning now to our financial guide, Vanda reinstates financial guidance and expects to achieve the following financial objectives in 2024. Total net product sales from FNAP, Tetlios, and Pombori of between $180 and $210 million. Year-end 2024 cash of between $360 million and $390 million. To note, Hetlio's net product sales will likely decline in future periods, potentially significantly, related to the continued generic competition in the U.S. Additionally, the company constrained Hetlio's net product sales for the year ended December 31st, 2023, and the first six months of 2024 to an amount not probable of a significant revenue reversal. As a result, Hetlio's net product With that, I'll now turn the call back to Mihael.

Mahalis: Turning now to our financial guidance.

Mahalis: Vanda reinstates financial guidance and expects to achieve the following financial objectives in 2024. Total net product sales from FNAP, Tetlios, and Pombori of between $180 million and $210 million. Year-end 2024 cash of between $360 million and $390 million.

Mahalis: To note, Hetlio's net product sales will likely decline in future periods, potentially significantly, related to the continued generic competition in the U.S.

Mahalis: Additionally, the company constrained Hetlio's net product sales for the year ended December 31st, 2023 and the first six months of 2024 to an amount not probable of significant revenue reversal.

Mihael H. Polymeropoulos: As a result, Hetlios Net Product Sales could experience variability in future periods, as the remaining uncertainties associated with variable consideration are resolved. With that, I'll now turn the call back to Mihael.

Mihael H. Polymeropoulos: Thank you very much, Kevin. At this point, we will be happy to answer your questions.

Mihael H. Polymeropoulos: Thank you very much, Kevin. At this point, we will be happy to answer your questions.

Operator: Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to redraw your question, simply press star 1 again. If you are called upon to ask a question and you're listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. And your first question comes from the line of Charles Duncan with Cancer Fitzgerald. Please go ahead.

Speaker Change: Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to redraw your question, simply press star 1 again.

Speaker Change: If you are called upon to ask a question and you're listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.

Speaker Change: And your first question comes from the line of Charles Duncan with Cancer Fits Jerome. Please go ahead.

Charles Cliff Duncan: Hi, Mihael and team, congrats on a good quarter's progress and really appreciate you reinstating the financial guidance for the second half of the year and all the color that you provided in the remarks. I have a couple of questions, FNAP, and then I'll hop back in the queue. But with regard to FNAP, I know that the launch just started this year or this quarter, but I guess I'm wondering, is there any feedback that you can share with regard to prescriber perspective following the recent label expansion? I think Kevin alluded to this recently in terms of new patient starts, but any perspectives that you can give with regard to prescribing for FNAP with that new label?

Charles Duncan: Hi Mihalis and team. Congrats on a good quarter progress and really appreciate you reinstating the financial guidance for the second half of the year and all the color that you provided in the in the remarks.

Speaker Change: I have a couple of questions on FNAP, and then I'll hop back in the queue. But with regard to FNAP,

Speaker Change: I know that the launch just started this year, or this quarter, but I guess I'm wondering, is there any feedback that you can share with regard to prescriber perspective following the recent label expansion?

Speaker Change: I think Kevin alluded to this recently in terms of new patient starts, but any perspectives that you can give with regard to prescribing for FNAP with that new label?

Mihael H. Polymeropoulos: Yes, maybe I'll start, and I'll have Kevin follow up on that. Thank you very much for joining us, Charles.

Speaker Change: Yes, maybe I'll start and I have Kevin follow up on that. Thank you very much for joining us.

Mihael H. Polymeropoulos: First of all, something environmental about this market: despite the fact that there are a number of antipsychotics approved for this type of indication, there's still a significant medical need for people who don't respond well to or do not tolerate well other drugs, and Shands, this market is promotionally sensitive. But there is competition in the market for share of voice, and therefore it requires significant investment, which we began making, to increase awareness. It is important to note that while schizophrenia is a very significant indication, the bipolar space of indications with Bipolar I Disorder is actually far more frequent and encountered in prescriber offices outside necessarily of psychiatry.

Speaker Change: First of all, something environmental about this market, it is that despite the fact that there are a number of antipsychotics

Speaker Change: approved for this type of indication. There's still a significant and met medical need for people who don't respond well or do not tolerate well other drugs.

Speaker Change: and Shands, this market is promotionally sensitive.

Shams: But there is competition in the market for share of voice and therefore it requires significant investment which we began making to increase awareness.

Shams: It is important to note

Shams: that, well, schizophrenia is a very significant indication.

Shams: The Bipolar Space of Indications

Shams: with Bipolar I Disorder is actually far more frequent and encountered in prescriber offices outside necessarily of psychiatry.

Mihael H. Polymeropoulos: And therefore, it presents a much larger opportunity. We are receiving, of course, anecdotal evidence of excitement about learning more about the data, and very significant participation of prescribers and new prescribers into our speaker program. And what we've noted are the early signs based on IQVIA data; we are referring to the trend on the NVRX, which is, you know, it is a metric of new starts, not refills, but new starts. And there, we see positive results compared to prior quarters and positive results compared to last year as a whole. It is early, and as you know, it takes some time to get the sales force out, create awareness, get the new starters, and get the refills. But typically, NVRXs are followed by NRXs and TRXs.

Shams: and therefore it presents a much larger opportunity.

Shams: We are receiving, of course, anecdotal evidence of excitement of learning more about the data, very significant participation of prescribers and new prescribers into our speakers program.

Shams: And what we noted is the early signs based on IQVIA data, we are referring to the trend on the NBRX, which as you know, it is a metric of new starts, not refills, but new starts.

Shams: We see positive results compared to prior quarters and positive results compared to last year as a whole.

Shams: It is early, and as you know, it takes some time.

Shams: to get the sales force out, create the awareness, get the new starts, get the refills. But typically NBRXs are followed by NRXs, NTRXs.

Mihael H. Polymeropoulos: But we want to make sure that everybody understands this is the quarter we're going to be first with the full sales force out. Our expansion continues, and our full marketing operations are not going to be in full swing until the fourth quarter of next year. So we're enthusiastic about the prospects of revenue growth, but we want to caution that it may take a few months before we get clear signs of the effect of our efforts.

Shams: But we want to make sure that everybody understands this is the quarter we're going to be first with the full sales force out.

Shams: Our expansion continues.

Shams: And our full marketing operations are not going to be in full swing, but in the fourth quarter of 2020.

Shams: next year. So we're enthusiastic about the prospects of revenue growth.

Shams: But we want to caution that it may take a few months before we get the clear signs of the effect of our efforts.

Charles Cliff Duncan: That makes good sense to us. And then I wondered if you could provide a perspective on the possibility that there could be another new entrant in terms of class to psychosis treatment, and that is with the muscarinic modulators with the possible approval of the candidate called CAR-XT this fall. Are you, I mean, I'm sure you're prepared for that, but what would be the response from your messaging in the face of that increased competition, or do you believe that the label is sufficiently differentiated and FNAP stands on its own to continue to gain share?

Speaker Change: That makes good sense to us. And then I wondered if you could provide a perspective on the possibility

Speaker Change: that there could be another new entrant in terms of class.

Speaker Change: to psychosis treatment, and that is with the muscarinic modulators with the possible approval of the candidate called CAR-XT.

Speaker Change: this fall. Are you, I mean, I'm sure you're prepared for that, but what would be the response from your messaging?

Speaker Change: In the face of that increased competition, or do you believe that the label is sufficiently differentiated and FNAP stands on its own to continue to gain share?

Mihael H. Polymeropoulos: Yeah, of course, we're looking at the competitive space, and we're becoming more and more familiar with this new class of drugs. And first of all, I would say it is terrific that, you know, after many years, folks are working on new mechanisms of action to address medical needs. So first, I would say we welcome more enthusiasm in the space and more attention to treat these difficult disorders. And I think a success of that drug will highlight the remaining medical need in space.

Speaker Change: Yeah, of course we're looking at the competitive space and we're becoming more and more familiar with this new class of drugs and, first of all, I would say it is terrific.

Speaker Change: that, you know, after many years folks are working on new mechanisms of action to address the mathematical needs. So first, I would say we welcome more enthusiasm in the space.

Speaker Change: and more attention to treat these difficult disorders. And I think a success of that drug will underscore the remaining medical need in the space.

Mihael H. Polymeropoulos: In terms of differentiation, we have to wait and see the profile, but I would say a strong factor in differentiating FANAP, not only from new entrants but also from the drugs in the market, is the tolerability profile. That is well understood; it is not a new entrant. The drug has been in the market for about 15 years since the first approval. So, there's a lot of experience and familiarity. So, we're looking at FNAP as a well-known friend that now has a new utility, and for new entrants, we welcome them all, and we welcome more education of psychiatrists and other specialties around these markets and drugs.

Speaker Change: In terms of differentiation, we have to wait and see the profile.

Speaker Change: But I would say a strong factor in differentiating FNAP not only from new entrants but also the drugs in the market is the tolerability profile.

Speaker Change: that is well understood. It is not a new entrant. The drug has been in the market for about 15 years since the first approval, so there is a lot of experience and familiarity.

Speaker Change: So we're looking at FNAPT as a well-known friend.

Speaker Change: that now has a new utility and for new entrants we welcome them all and we welcome more education of psychiatrists and other specialties around these markets and drugs.

Charles Cliff Duncan: One last question in terms of the pipeline with regard to tridipetan. When you think about gastroparesis versus motion sickness, do you think gastroparesis is a nice-to-have or a need-to-have in terms of your view of where Vanda can be in a year with regard to commercial opportunities, or is motion sickness perhaps a little bit more consistent with some of your marketing efforts thus far? You mentioned filing later this year. Does that depend on what the agency has provided you with or will provide you with regard to a response to gastroparesis? Thank you.

Speaker Change: One last question in terms of the pipeline with regard to Tredipitan. When you think about gastroparesis versus motion sickness,

Speaker Change: Do you think gastroparesis is a nice-to-have or a need-to-have in terms of your...

Speaker Change: Vanda can be in a year with regard to commercial opportunities.

Speaker Change: or is motion sickness perhaps a little bit more consistent with some of your marketing efforts thus far?

Speaker Change: and you mentioned filing later on this year, does that depend on what the agency has provided you or will provide you with regard to a response on gastroparesis? Thank you.

Mihael H. Polymeropoulos: Yeah, I'll take the two parts of the question separately. We believe that tradiptin has a useful effect in treating symptoms of gastroparesis, which is a significant and mathematical need. And the testimony to that does not come just from our clinical trial results, all of which have been published, but also, and this is personally exciting to me, the dozens of patients who have come over the years to request and be granted expanded access.

Speaker Change: Yeah, I'll take separately the two parts of the question. We believe that tridiptine has a useful effect in treating symptoms of gastroparesis.

Speaker Change: which is a significant and medical need and the testimony of that does not come just from our clinical trial results all of them have been published

Speaker Change: but also by what is personally exciting to me, the dozens of patients who have come over the years to request and be granted expanded access.

Mihael H. Polymeropoulos: We just celebrated our first patient, four years on the drug, you know, with her testimony of the drug changing her life. So if you see it from the patient's perspective, I think it is very important that Rediptant makes it to the Herbamentarium of Drugs for Gastroparesis. But given the diversification of revenue that the company has and the deep, diversified, and staged pipeline, we can tolerate a delay in approval, which I guess that's the signal we can interpret now.

Speaker Change: We just celebrated our first patient.

Speaker Change: four years on the drug, you know, with her testimony of the drug changing her life. So, if you see it from the patient need, I think it is very important that Rediptant makes it to the armamentarium of drugs for gastroparesis.

Speaker Change: But given the diversification of revenue that the company has,

Speaker Change: and the Deep and Diversified States Pipeline, we can tolerate a delay in approval, which I guess that's the signal we can interpret now.

Mihael H. Polymeropoulos: When it comes to motion sickness, the motion sickness filing, and motion sickness approval, it is unlikely that it depends on anything we learn from the FDA. The FDA will likely point to their questions around the strength of efficacy, and they will point back to long-term preclinical safety additional data they may need. There's no question about efficacy that the drug prevents vomiting in the setting of motion sickness, and that's something that we have extensively discussed and agreed upon with the FDA in end-of-phase 2 and pre-NDA meetings.

Speaker Change: When it comes to motion sickness...

Speaker Change: The motion sickness filing and motion sickness approval, it is unlikely it depends on anything we learn from the FDA.

Speaker Change: The FDA will likely point to their questions around the strength of efficacy, and they will point back to long-term preclinical safety additional data they may need.

Speaker Change: However, when it comes to motion sickness...

Speaker Change: There's no question about efficacy that the drug prevents vomiting in the setting of motion sickness. And that's something that we have extensively discussed and agreed upon with the FDA in end-of-phase 2 and pre-MDA meetings.

Mihael H. Polymeropoulos: And when it comes to safety, we think we're going to have a complete package, both preclinical and clinical, given the incidental and not chronic use of this drug. So we feel very confident that our package will be complete. Very helpful. I think in the queue we have more.

Speaker Change: And when it comes to safety, we think we're going to have a complete package, both preclinical and clinical, given the incidental and not chronic use of this drug. So we feel very confident that our package will be complete.

Charles Cliff Duncan: Very helpful. I'll have that in the queue. I have more questions, but maybe I'll give someone else a shot.

Speaker Change: Very helpful. I'll type in the queue, have more questions, but maybe give someone else a shot.

Operator: Again, if you would like to ask a question, press star 1 on your telephone keypad. Your next question comes from the line of Andrew Chai from Jefferies. Please go ahead.

Speaker Change: Again, if you would like to ask a question, press star one on your telephone keypad.

Andrew Chai: Hi, thanks. Good afternoon.

Speaker Change: Your next question comes from the line of Andrew Chai from Jefferies. Please go ahead.

Operator: Thanks for taking my questions. The revenue guidance range is pretty wide, a $30 million range, despite us being two quarters in. So what exactly is your revenue guidance assuming for the type of quarterly sales growth for both Ponvori and FNAP in the second half of 2024? What gets you to the high end of the guidance? Thanks.

Andrew Chai: Hi. Thanks. Good afternoon. Thanks for taking my questions.

Andrew Chai: The revenue guidance range is pretty wide, $30 million range, despite us being two quarters in. So what exactly is your revenue guidance assuming for the type of quarterly...

Speaker Change: Sales growth for both Ponvori and FNAP in second half 2024. What gets you to the high end of the guidance? Thanks

Kevin Patrick Moran: I'll let Kevin take that. Hey Andrew.

Andrew Chai: Hey, Andrew. Yeah, so as we mentioned, obviously, with the launch of FNAP and Pumbori happening now in the third quarter and as you mentioned, you know, two quarters in, the trajectory of the launches and how quickly we begin to see results that, you know, if we start to see results, you know, fairly quickly, we think that we could end up at the top end of the range, whereas if it takes a little bit longer time for those results to translate into revenue, you know, it could come later in the year and therefore be closer to the, you know, the middle of the range or somewhere else in the range.

Kevin Patrick Moran: I'll let Kevin take that. Hey, Andrew. Yeah, so as we mentioned, obviously, with the launch of FNAF and Pumbori happening now in the third quarter, and as you mentioned, you know,

David C.: two quarters in, the trajectory of the launches, and how quickly we begin to see results. If we start to see results fairly quickly, we think that we could end up at the top end of the range, whereas if it takes a little bit longer time for those results to translate into revenue, it could come later in the year, and therefore be closer to the middle of the range or somewhere else in the range.

Kevin Patrick Moran: And in terms of the cash guidance, it seems like there will be some expected cash burn year-over-year exiting 2024. But as we exit 2024 and head into 2025, do you think you can be cash flow positive, or should we be expecting increased investments in the launches and pipeline growth to more than offset the revenues you bring in?

Speaker Change: And in terms of the cash guidance, seems like there will be some expected cash burn year-over-year exiting 2024. But as we exit 2024 and head into 2025, do you think you can be cash flow positive, or should we be expecting increased investments in the launches and pipeline growth to more than offset the revenues you bring in?

Kevin Patrick Moran: Yeah. So first, our communicated guidance is that we'll end the year between 360 and 390. The high end of that range would be slightly cash flow positive, very slight. And the, you know, the bottom end of the range would be, you know, a burn in the neighborhood of 25 to 30 million. And therefore, the midpoint, right, is obviously a smaller number than that.

Speaker Change: Yeah, so first on the cash guidance for this year is, you know, our communicated guidances that will end the year between 360 and 390, the high end of that range would be slight cash flow positive, very slight, and, you know, the bottom end of the range would be, you know, a burn in the neighborhood of 25 to 30 million, and therefore the midpoint rate is obviously a smaller number than that. If we end up at the top point of our revenue range, then we could even see, you know, to be right around the cash break-even number or maybe a little bit better, a little bit worse, right? So that's just for the trajectory of this year. Obviously, we haven't provided guidance for next year, so you can only kind of speak to in the context of what we've communicated, but if we begin to see revenue growth as we hope for and anticipate on these two products, and we continue to make the investments that we've articulated.

Kevin Patrick Moran: If we end up at the top point of our revenue range, then we could even see, you know, to be right around the cash break-even number or maybe a little bit better, a little bit worse, right? So that's just for the trajectory of this year. Obviously, we haven't provided guidance for next year, so you can only kind of speak to them in the context of what we've communicated. But if we begin to see revenue growth as we hope for and anticipate on these two products, and we continue to make the investments that we've articulated, you know, next year, we could see revenue growth that could necessitate additional investments, or we could see it be, you know, kind of efficiently converted into positive VPS.

Speaker Change: [inaudible]

Andrew Chai: Thanks. And for Tridivitant, let's just say it was approved later in September. Can you guys talk about your launch strategy?

Speaker Change: Okay, thanks. And for Tridipitant, let's just say it was approved later in September . Can you guys talk about your launch strategy?

Mihael H. Polymeropoulos: Yeah, absolutely. We actually have had, you know, quite a bit of time to work out our launch plan. And we feel well prepared; of course, we depend on the labeling, with the messaging, we understand the target population well, and we have cultivated extensive relationships with key opinion leaders. So we understand the size of a sales force, we understand the effort and size of the speaker program. And, of course, we have early plans of what a direct-to-consumer campaign can do in this indication.

Andrew Chai: And the last question is, Salesforce is 3x larger than earlier in the year. How many sales reps did you have earlier in the year? So we can do the math here.

Speaker Change: Yeah, absolutely. We actually have had, you know, quite a bit of time.

Speaker Change: to work our launch plan and we feel well prepared. Of course we depend on the labeling.

Speaker Change: With the messaging, we understand well the target population.

Speaker Change: We have cultivated extensive...

Speaker Change: relationships with key opinion leaders.

Speaker Change: So, we understand the size of a sales force. We understand the effort and size of speakers' program, and of course, we have early plans of what a direct-to-consumer campaign can do in this indication.

Speaker Change: I see.

Speaker Change: And the last question is, Salesforce is 3x larger than earlier in the year. How many sales reps did you have earlier in the year, so we can do the math here? Yes, the sales reps in the early part of the year were in the neighborhood of about 50, and so with it being 3 times larger, we're a little north of 150.

Mihael H. Polymeropoulos: Yes, the sales reps in the early part of the year were in the neighborhood of about 50, and so with it being three times larger, we're a little north of 150.

Andrew Chai: Perfect. Okay, thank you. Congratulations on the quarter. Thanks, Andrew.

Speaker Change: Perfect. Okay, thank you. Congrats on the quarter.

Andrew Chai: Thanks, Andrew. Thanks, Andrew.

Operator: Again, if you would like to ask a question, press star 1 on your telephone keypad. We have no more questions in queue. I will now turn the conference back over to Vanda Management for closing remarks. Please go ahead. Thank you very much.

Speaker Change: Again, if you would like to ask a question, press star 1 on your telephone keypad.

Speaker Change: We have no more questions in queue. I will now turn the conference back over to Vanda Management for closing remarks. Please go ahead.

Mihael H. Polymeropoulos: Thank you very much for joining us on our second quarter 2024 call, and we hope to see you again soon. This concludes the conference call. You may now disconnect.

Vanda Management: Thank you very much for joining on our second quarter 2024 call, and we hope to see you again soon.

Speaker Change: This concludes the conference call. You may now disconnect.

Operator: Thank you for watching!

Speaker Change: The following is a work of fiction. Any resemblance to persons, living or dead, is coincidental and unintentional.