Q2 2024 Supernus Pharmaceuticals Inc Earnings Call
Okay.
Unknown Executive: Good afternoon and welcome to the Supernus Pharmaceuticals Second Quarter, 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session.
Speaker Change: Good afternoon, and welcome to the Super Nice Pharmaceuticals second quarter 2024 Financial result conference call.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: Later, we will conduct a question and answer session and instructions will follow at that time as a reminder, this conference call is being recorded.
Unknown Executive: Instructions will follow at that time. As a reminder, this conference call is being recorded.
Peter Vozzo: I would now like to turn the conference over to Peter Vozzo of ICR Westwick, Investor Relations representative for Supernus Pharmaceuticals. You may begin now.
Peter Bozzo: I would now like to turn the conference over to Peter Bozzo of ICR Westwick Investor Relations Representative force. It permits pharmaceuticals, you may begin now.
Unknown Executive: Thank you, Corinne.
Peter Bozzo: Thank you Karen good afternoon, everyone and thank you for joining us today for British Pharmaceuticals second quarter 2000, <unk> financial results conference call today. After the close of the market. The company issued a press release announcing these results.
Unknown Executive: Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' second quarter 2024 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results.
Peter Vozzo: On the call with me today, our Supernus' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Deck. The base call is being made available via the Investor Relations section of the company's website at IR.supernus.com.
On the call with me today are surprises Chief Executive Officer, Jack is our Chief Financial Officer.
Peter Bozzo: <unk> is being made available via the Investor Relations section of the company's website at IR.
Unknown Executive: During the course of this call, the management may make certain forward-looking statements regarding future events in the company's future performance. These forward-looking statements reflect the current perspective on existing trends in information. Any such forward-looking statements are not guaranteed with future performance and involve risks and uncertainties, including those noted in the risk factor section of the company's latest FTP filings. Actual results may get materially from those projected in these forward-looking statements.
Peter Bozzo: During the course of this call management.
Certain forward looking statements regarding future events and the company's future performance. These forward looking.
Peter Bozzo: Statements reflect.
Current perspective on existing trends and information and as such forward looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the risk factors section of the company's needs.
Peter Bozzo: E filings.
Peter Bozzo: Actual results may differ materially from those projected in these forward looking statements for the benefit of those of you who may be listening to the replay. This call is being held and recorded on August six 2024. Since then the company may have.
Unknown Executive: For the benefit of those of you who may be listening to the replay, this call is being held and recorded on August 6, 2024. Since then, the company may have made additional announcements related to the topics discussed. These reference to companies' most recent pressure releases and current filings to the FTP.
Peter Bozzo: Made additional announcements related topics discussed please reference the company's most recent press releases and filings.
Unknown Executive: Supernus declined any obligations to update these forward-looking statements except as required by the total security laws announcing the call of the jack.
Peter Bozzo: So price declines any obligation to update these forward looking statements, except as required by law.
Peter Bozzo: Securities laws.
Peter Bozzo: Now I'll turn the call to Jeff.
Peter Vozzo: Thank you, Peter.
Thank you Peter and good afternoon, everyone and thanks for taking the time to join us on today's call.
Jack Khattar: Good afternoon, everyone, and thanks for taking the time to join us on today's call. In the second quarter of 2024, we delivered strong net sales growth from our key growth drivers, Calgary and Low-Covery, and continued to advance our product pipeline, including SBN 817 for treatment-resistant schedules and SBN 820 for depression. Total branding use, excluding pretend the XOR and OX Stellar XOR increased 32% in the second quarter. Driving this growth was Calgary's strong performance, with 26% growth in prescriptions, as reported by IQVIA, and 92% growth in net sales. Prescriptions reached an all-time quarterly high of 184,342, and net sales were 59 million dollars.
Jeff: In the second quarter when he bought it for me.
Jeff: Strong net sales growth from our key growth drivers Cambrian recovery. Thank you.
Speaker Change: Need to advance our product pipeline, including SPN 8174 treatment resistance seizures and SPN 824.
Jeff: Sure.
Jeff: Total revenues, excluding <unk> increased 32% in the second quarter.
Jeff: Driving this growth was categories strong performance with 26% growth in prescriptions as reported by IQ here and 92% growth in net sales.
<unk> reached an all time quarterly high of 184342 net sales were $59 million.
Jack Khattar: In the first six months of 2024, Tellview prescriptions grew by 28% compared to the same period last year, and net sales were 105 million, representing an 84% growth over the same period last year. Growth in net sales of Calgary in the second quarter of 2024 benefited from both prescription growth and growth net improvements compared to the same period last year. Growth net deductions during the second quarter of this year were below our target range of 50 or 55%. We saw more favorable product returns trend with initial loan patches experiencing lower return rates than assumed and continued lower co-paid deductions in the quarter.
Jeff: In the first six months of 'twenty 'twenty four Calgary prescriptions grew by 28% compared to the same period last year and net sales were $105 million, representing an 84% growth over the same period last year.
Jeff: Gross and net sales of Calgary in the second quarter of 2024.
Jeff: Both prescription growth and gross to net improvement compared to the same period last year.
Jeff: Gross connect deductions during the second quarter of this year were below our target range of 50% to 55% we.
Jeff: We saw a more favorable product returns trend with initial launch batches experiencing lower return rates and assume and continued lower co pay deductions in the quarter as a result for the remainder of 2024, we expect the gross to net for category to be in the 45% to 50% range.
Jack Khattar: As a result for the remainder of 2024, we expect the growth to net for Calgary to be in the 45-50% range with fluctuations that we would typically expect on a quarterly basis. During the second quarter, Calgary also expanded its base of prescribers, ending the quarter with approximately 28,326 prescribers, up from 27,138 in the first quarter of this year. As you recall earlier this year, we saw a significant increase in sample distribution by physicians to patients to help them through their out-of-pocket expenses in the first quarter. This negatively impacted our prescriptions in the first quarter by the reverse in the second quarter as patients started transitioning from their samples to re-hilling the prescriptions.
Jeff: With fluctuations that you would typically expect on a quarterly basis.
Jeff: During the second quarter Calgary also expanded its base of prescribers ending the quarter with approximately 28326 prescriptions prescribers up from 27138 in the first quarter on the SKU.
Unknown Executive: Prescriptions from adult patients now account for approximately 32% of Calgary's total prescriptions.
Jeff: Restrictions from adult patients now accounts for approximately 32% of Caribees total prescriptions.
Jeff: Switching now to recovery net sales increased to $32 million in the second quarter of 2024, representing a healthy increase of 10% over the same period in 2023, and reflecting recovery from some of the negative factors as the brand space in the first quarter of 2024.
Speaker Change: As you'll recall earlier this year, we saw a significant increase in sample distribution by physicians to patients to help them through their out of pocket expenses in the first quarter. This negatively impacted our prescriptions in the first quarter, but reversed in the second quarter as patients started transitioning.
Jeff: Their samples to refilling their prescriptions.
Jack Khattar: Switching our legacy products of Stellar XR net sales for the second quarter, $24.3 million, compared to $24 million in the second quarter of last year. And for 30XR, the second quarter net sales was $17 million, down by 12% from the same quarter last year. For the first six months of 20XR, net sales of 30XR were down 39%. We expect further erosion in 30XR sales and the entry of Stellar XR genetics later this year. Given the trends in the first half of 2024, we now anticipate combined net sales of 10XR and NX Stellar XR in 2024 to be in the range of $135 million to $145 million.
Jeff: Switching to our legacy products socks pellet XR net sales for the second quarter of 2024 were $30 million compared to $24 million in the second quarter of last year.
Jeff: And for Trokendi XR second quarter, net sales were $17 million down by 12% from the same quarter last year.
Jeff: For the first six months.
Jeff: Net sales of Trokendi XR were down 39%.
Jeff: We expect further erosion in Trokendi XR sales and the NCO stellar XR generics later this year given.
Jeff: Given the trends in the first half of 'twenty 'twenty four we now anticipate combined net sales of Trokendi, XR <unk> XR and <unk>.
Jeff: 'twenty 'twenty four to be in the range of $135 million to 145 million.
Jack Khattar: Regarding SBNH 30 release, admitted the NDA last week and expected to run from the FDA in a few weeks. Whether this submission will be considered as a class one requiring a two months review or a class two requiring a six months review. We remain committed to Parkinson's patients who need this potential new treatment option.
Jeff: Regarding SPN 830 release submitted the NDA last week and expect to learn from the FDA in a few weeks whether this submission will be considered as a class one requiring a two months review or class II, requiring six months review.
Jeff: We remain committed to Parkinson's patients, who need this potential new treatment option.
Jack Khattar: Moving on to our CNS pipeline of novel product candidates, we have exciting catalysts coming up in the next six to twelve months. For 820, the company expects to provide data from its face-to-be study in adults with treatment-resistant depression in the first half of 2025. Three quarters of the targeted number of patients are now enrolled in the study. Also, enrollment in the phase two open label study in patients with major depression disorder is ongoing, and pipeline results from that study are expected by the end of this year. In May 2024, we announced data from the planned interim analysis of our exploratory open label Phase Two A study of SBN 817 for treatment resistance seizures.
Jeff: Moving onto our CNS pipeline of novel product candidates, we have exciting catalysts coming up in the next six to 12 months.
Jeff: Or H 'twenty the company expects to provide data from its phase <unk> study in adults with treatment resistant depression, and the first fab 25.
Jeff: Leap orders of the targeted number of patients are now enrolled in the study.
Jeff: Also enrollment in the phase two open label study in patients with major depressive disorder is ongoing and top line results from that study are expected by the end of this year.
Jeff: In May 2024, we announced data from the planned interim analysis of our exploratory open label Phase Iia study of SPN 8174 treatment resistance seizures. The interim analysis was based on 41 enrolled subjects of which 19 completed the maintenance period at a time.
Jack Khattar: The interim analysis was based on 41 in the old subjects, of which 19 completed the maintenance period and of time. We continue to expect pipeline results for the full study in the second half of this year. In addition, the phase 2D randomized double-blind placebo control study with SBN 817 and patients with treatment resistant focal seizures is expected to start by the end of 2024. Also, we plan to initiate a Phase 1 single dose study of SBN 443 in healthy adults following submission of an IND. SBN 443 is our news stimulant-like product candidate for AD to be and other CNS disorders.
Jeff: We continue to expect top line results for the full study in the second half of this year.
Jeff: In addition, a phase II randomized double blind placebo controlled study with SPN eight one.
Jeff: Patients with treatment resistant focal seizures is expected to spud by the end of 2024.
Jeff: Also we plan to initiate a phase one single dose study of SPM 443 in healthy adults following submission of an IND.
Jeff: D.
Jeff: <unk> or <unk>, our newest stimulant like product candidates for ADHD and other CNS disorders.
Jack Khattar: Finally, we remain active in corporate development, looking for strategic opportunities to further strengthen our future growth and need of your position and CNS.
Jeff: We remain active in corporate development looking for strategic opportunities to partner.
Jeff: And our future growth and leadership position in CNS with that I will now turn the call over to Deb.
Tim Deck: With that, I will now turn the call over to them.
Tim Deck: Thank you, Jack. Good afternoon, everyone. As I review our second quarter of 2024 results, please refer to today's press release and 10 few that were filed earlier today. So, revenue for the second quarter of 2024 was 168.3 million compared to 135.5 million in the same quarter last year. So, revenue, the second quarter of 2024 was comprised of net product sales of 162.5 million and royalty licensing and other revenues of 5.8 million. The increase in net product sales was primarily due to the increase in net product sales or growth products. Calvary Hendo-Covery as well as Oxceler XR.
Deb: Thank you Jack good afternoon, everyone.
Deb: As I review, our second quarter 2024 results. Please refer to today's press release and 10-Q that were filed earlier today.
Deb: Total revenue for the second quarter of 2024 was $168 3 million compared to $135 5 million in the same quarter last year.
Jeff: Total revenue in the second quarter of 2024 was comprised of net product sales of $162 5 million and royalty licensing and other revenues of $5 $8 million.
Jeff: The increase in net product sales was primarily due to the increase in net product sales of our growth products.
Speaker Change: Calgary hand go Cauvery as well as our stellar XR.
Tim Deck: Excluding net product sales of Corkendi XR and Oxceler XR, total revenues for the second quarter of 2024 increased 32% compared to the same quarter last year. For the second quarter of 2024, combined R&D and SGA expenses were 112.1 million, as compared to 111.2 million for the same quarter last year. This slight increase was primarily due to R&D spend associated clinical programs for SBN 817 and SBN 820 as we continue to progress our pipeline. Operating earnings on a GAAP basis for the second quarter of 2024 was 22.6 million, as compared to an operating loss of 17.6 million for the same quarter last year.
Jeff: Excluding net product sales of Trokendi, XR and accelerates our total revenues for the second quarter of 2024 increased 32% compared to the same quarter last year.
Unknown Executive: For the second quarter of 2024, combined R&D and SG&A expenses were $112.1 million, as compared to $111.2 million for the same quarter last year. This slight increase was primarily due to R&D spend associated with clinical programs for SBN 817 and SBN 820 as we continue to progress our pipeline.
Jeff: For the second quarter of 2020 for combined R&D and SG&A expenses of $112 1 million as compared to $111 2 million for the same quarter last year.
Jeff: The slight increase was primarily due to R&D spend associated with the clinical programs for SPN 817 in SPN eight 'twenty as we continue to progress our pipeline.
Unknown Executive: Operating earnings on a gap basis for the second quarter of 2024 was $22.6 million, as compared to an operating loss of $17.6 million for the same quarter last year, income tax expense in the second quarter of 2024 was $6.4 million. Gap net earnings was $19.9 million for the second quarter of 2024, or $0.36 per diluted share, compared to a gap net loss of $831,000 or $0.02 loss for diluted share in the same quarter last year, on a non-GAAP basis, which excludes amortization and intangibles, share-based compensation, contingent consideration and appreciation, adjusted operating earnings for the second quarter of 2024 was $45.5 million compared to $10 million in the same quarter last year.
Jeff: Operating earnings on a GAAP basis for the second quarter of 2024 was $22 6 million as compared to an operating loss of $17 6 million for the same quarter last year.
Tim Deck: Income tax expense in the second quarter of 2024 was $6.4 million. Gap net earnings was 19.9 million in the second quarter of 2024, or 36 cents per diluted share, compared to a gap net loss of 831,000, or 2 cents loss per diluted share in the same quarter last year. On a non-gap basis, which excludes amortization in tangibles, share-based compensation, contingent consideration, and depreciation adjusted to operating earnings for the second quarter of 2024 was 45.5 million compared to 10 million in the same quarter last year. So revenues for the six months ended June 30, 2024, were 312 million compared to 289.3 million in the same period last year.
Jeff: Income tax expense in the second quarter of 2024 or $6 4 million.
Jeff: GAAP net earnings was $19 9 million for the second quarter of 2024 or 36 cents per diluted share.
Jeff: Compared to a GAAP net loss of 831000 or two cents loss per diluted share in the same quarter last year.
Jeff: On a non-GAAP basis, which excludes amortization of intangibles and share based compensation contingent consideration and depreciation adjusted operating earnings for the second quarter of 2024 was $45 5 million compared to $10 million in the same quarter last year.
Unknown Executive: Total revenues for the six months ended June 30, 2024 were $312 million, compared to $289.3 million in the same period last year, and $16.1 million or $0.29 per diluted share in the same period last year. That is a 67% increase in adjusted operating earnings compared to the same period last year. As of June 30, 2024, the company had approximately $347.2 million in cash, cash equivalents, and current and long-term marketable securities, compared to $271.5 million as of December 31, 2023.
Jeff: Total revenues for the six months ended June 32024, or $312 million compared to $289 3 million in the same period last year.
Tim Deck: Total revenues were comprised of net product sales of $301 million, and royalties, licensing, and other revenue of $11 million. Compared to second quarter 2024 results, the 12% increase in net product sales was primarily due to the increase in net product sales of Calgary, GoCovery, and Xteler XR. Excluding net product sales or pretending XR and Xteler XR, total revenues for the six months ended June 30th, 2024 increased 22% compared to the same period last year. Combined R&D and SBA expenses for the six months ended June 30th, 2024 were 223.5 million, as compared to 218 million for the same period last year.
Jeff: Total revenues were comprised of net product sales of $301 million.
Jeff: Royalties licensing and other revenue of $11 million.
Jeff: Compared to second quarter 2024 results, a 12% increase in net product sales was primarily due to the increase in net product sales of Calgary go coffee and <unk> XR.
Jeff: Excluding net product sales for Trokendi XR <unk> XR total revenues for the six months ended June 32024 increased 22% compared to the same period last year.
Jeff: Combined R&D and SG&A expenses for the six months ended June 32024, or $223 5 million as compared to $218 million.
Jeff: For the same period last year.
Tim Deck: Again, this increase was primarily due to R&D expenses associated with clinical programs for SBN 817 and SBN 820 as we continue to progress our pipeline. Operating earnings on a GAAP basis for the six months ended June 30th, 2024, were 19.4 million as compared to an operating loss of 12.4 million for the same period last year. That is a $31.8 million increase in operating earnings compared to the same period last year. For the six months ended June 30th, 2024, we were putting income tax expenses 6.5 million. Gap net earnings were 20 million for the six months ended June 30th, 2024, or 36 cents per diluted share.
Jeff: Again this increase was primarily due to R&D expenses associated with clinical programs for SPN 817, <unk> 'twenty as we continue to progress our pipeline.
Jeff: Operating earnings on a GAAP basis for the six months ended June 32024, or $19 4 million as compared to an operating loss of $12 4 million for the same period last year.
Jeff: That is a $31 million increase in operating earnings compared to the same period last year.
Jeff: For the six months ended June 32024, we reported income tax expense of $6 5 million.
Jeff: GAAP net earnings were $20 million for the six months ended June 32024, or 36 per diluted share.
Tim Deck: Compared to 16.1 million or 29 cents per diluted share in the same period last year. On a non-gap basis, which again excludes amortization and tangibles, share-based comp, contingent consideration, and depreciation, adjusted operating earnings were 67.7 million compared to 40.5 million in the same period last year. That is a 67% increase in adjusted operating earnings compared to the same period last year. As of June 30th, 2024, the company had approximately 347.2 million in cash, cash equivalents, and current and long-term marketable securities. Compared to 271.5 million as of December 31st, 2023, this increase was primarily due to cash generated from operations.
Jeff: Third to $16 1 million or 29 cents per diluted share in the same period last year.
Jeff: On a non-GAAP basis, which again excludes amortization of intangibles and share based comp contingent consideration.
Jeff: <unk> adjusted operating earnings were $67 7 million compared to $40 5 million in the same period last year.
Jeff: That's a 67% increase in adjusted operating earnings compared to the same period last year.
Jeff: As of June 32024, the company had approximately $347 2 million in cash cash equivalents and current and long term marketable securities.
Jeff: Third to $271 5 million as of December 31, 2023.
Unknown Executive: This increase was primarily due to cash generated from operations. For full year 2024, the company raised its financial guidance for total revenue and gap and non-gap operating earnings, while reiterating combined R&D and SG&A expenses and non-GAAP operating earnings to range from $100 million to $125 million. Please refer to the audience press release issued prior to this call that identifies the various ranges of reconciling items between GAP and non-GAP. With that, I will now turn the call back over to the operator for Q&A.
Jeff: This increase was primarily due to cash generated from operations.
Tim Deck: It should be noted that we have generated approximately 200 million cash from operations in the past 18 months. Because of that, the company has a strong balance sheet with no debt, with significant financial flexibility for potential M&A and other growth opportunities.
Jeff: It should be noted that we have generated approximately 200 million in cash from operations in the past 18 months.
Jeff: Because of that the company has a strong balance sheet with no debt with significant financial flexibility for potential M&A and other growth opportunities.
Tim Deck: Answering the guidance. For full year 2024, the company raises its financial guidance for total revenue and GAAP and non-GAAP operating earnings while reiterating combined R&D and SBA expenses. As a result, we expect total revenue to range from 600 million to 625 million, up from the previous range of 580 to 620 million, compared to net product sales, royalties, licensing, and other revenue. For the full year 2024, we expect combined R&D and SBA expenses to range from 430 million to 460 million. Overall, we've spent four-year 2024 gap operating earnings to range from grade-even to 20 million, and nine gap operating earnings to range from 100 million to 125 million.
Jeff: Now turning to guidance.
Jeff: For full year 2024, the company raises its financial guidance for total revenue and GAAP and non-GAAP operating earnings.
Jeff: Reiterating combined R&D and SG&A expenses.
Jeff: As a result.
Jeff: We expect total revenue to range from $600 million to $625 million.
Jeff: Up from the previous range of $580 million to $620 million comprised of net product sales royalties licensing and other revenue.
Jeff: For the full year 2024, we expect combined R&D and SG&A expenses to range from $430 million to $460 million.
Jeff: Overall, we expect full year 2024, GAAP operating earnings to range from breakeven to $20 million.
Jeff: non-GAAP operating earnings to range from $100 million to a 125 million.
Tim Deck: Please refer to the artist's press release issue prior to this call that identifies the various ranges of reconciled items between GAAP and non-GAAP.
Jeff: Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP.
Tim Deck: With that, I will now turn the call back over to the operator for Q&A. Thank you.
Speaker Change: With that I will now turn the call back over to the operator for Q&A.
Speaker Change: Thank you.
Unknown Executive: At this time, we will now conduct a question-to-answer session. To ask a question, you need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster.
Operator: At this time, we will now conduct a question and answer session. To ask a question, you need to press star, 1, 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star, 1, 1 again. Please stand by while we compile the Q&A roster.
Speaker Change: At this time, we will now conduct a question and answer session to ask a question.
Unknown Participant: It makes sense. Thanks.
Speaker Change: Press Star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again, please standby, while we compile the Q&A roster.
Andrew Tsai: Next question comes from Andrew Tsai of Jefferies. Your line is now open.
Speaker Change: Our question comes from Andrew Tsai of Jefferies. Your line is now open.
Andrew Tsai: Hi, good afternoon. Congrats on a nice quarter. Thanks for taking my questions.
Andrew Tsai: Hi, good afternoon, congrats on a nice quarter. Thanks for taking my questions. The first one.
Andrew Tsai: The first one is on FBM 830, the April Marketing Pump. Congrats on the recent meeting that just wanted to gauge your level of confidence. It will be approved this time. It's kind of interesting since we know the competitor also received a CR recently. So maybe talk about your level of confidence about this. Thanks. Yeah, sure. A couple of things. I mean, the first time we got a CRL. I try to give the example that probably was, you know, few pages. This time we got the CRL that was maybe half a page, you know, give or take, just to make an example of the number of issues we're dealing with.
April Martin: On SPN 830, the April Martin of congrats on resubmitting that just wanted to gauge your level of confidence.
Speaker Change: It will be approved this time, it's kind of interesting since we know the competitor also receive a CR recently.
Speaker Change: So maybe talk about your level of confidence about this.
Speaker Change: Yes sure.
Speaker Change: So a couple of things I mean, the first time, we've got our CRM.
Speaker Change: Try to give the example that probably was.
Speaker Change: Few pages. This spine, we got the <unk> as it was maybe it hasnt page.
Speaker Change: Take adjustments make an example of a number of issues we are dealing with certainly.
Jack Khattar: So certainly, with this resubmission, the number of issues we're dealing with was much, you know, lower number of items and issues that we have to address. The second thing is we did have a meeting with the FDA, you know, before the resubmission to make sure we have the fullest, you know, level of confidence before we resubmit. So we feel pretty good about the filing right now and our chances of getting approved. Of course, as I mentioned in our remarks, what we still not sure about is whether it will be a class one or class three resubmission, but hopefully we'll have that piece of information in the next few weeks when they have Behave accepts the filing and assigns it to do for the review.
Speaker Change: With this resubmission the number of issues were dealing with was much.
Speaker Change: Lower number of items and issues that we had to address.
Unknown Participant: And shifting to 8.1.7, we're going to have the full Phase 2a data cut later this year. Can you remind us, I think 19 of 41 patients completed the maintenance period. How many more patients do you think will be completing that maintenance period? And how many more specifically at the 3 to 4 mg dose, the high doses?
Andrew Tsai: Makes sense.
Andrew Tsai: Thanks. And shifting to 817, we're going to have the full Phase 2A data cut later this year. Can you remind us, I think, 19 of 41 patients completed the maintenance period. How many more patients do you think will be completing that maintenance period, and how many more specifically at the 3 to 4 milligram dose, the high doses? Yeah, at that time, in May, when we reported the interim results, in addition to the 19, we had about 7 or 8, if I remember the number correctly, patients were still in the study at various stages. So we would expect, you know, when we report the full results to have, you know, at least another, maybe I don't know, 5, 6 depending on how many discontinued or how many stay in all the stages of the study.
Speaker Change: But to directly of patients in the study at various stages.
Speaker Change: So we would expect.
Speaker Change: We report the full.
Speaker Change: Results.
Speaker Change: At least another maybe I don't know five six depending on how many discontinue on how many stay at this.
Speaker Change: The stages of the study, but we certainly have that it did a handful of people. In addition to the 19 that we will report on.
Jack Khattar: We should have it, you know. It did handful of people in addition to the 19 that we will report on.
Jack Khattar: So that's that. Will complete the initial portion of the study. Just to clarify, the second portion was the extension, which we talked about back in May, where we are going to test a couple strategies. One of them is adding an antibiotic where, you know, we try to address the nausea and so forth. So that portion of the study has already started, but we won't have data in the fourth quarter or before year end of this year. Just to clarify that the two different pieces of the study.
Speaker Change: So thats that will complete the initial portion of the study just to clarify the second portion was the extension, which we talked about back in May where we are going to.
Speaker Change: Thats coupled strategies one of them is adding an anti emetic, where we tried to address the <unk> and so forth. So that portion of the study.
Speaker Change: Has already started but we won't have data in the fourth quarter or before year end.
Speaker Change: For this year just to clarify that.
Speaker Change: Two different pieces of the study.
Andrew Tsai: The initial one, which we will report on, but the extension which we added in May, we will not have the data to report on. Okay.
Speaker Change: The initial one which we will report on but the extension, which we added in May we will not have the data to report on that.
Unknown Participant: Okay. And the last one is on A20, the depression asset, you're having pulsatile data in 40 patients with MDD later this year. Can you just remind us how long the study is and what kind of Madras or Hamdi efficacy benefit you want to see at the end of the study? What would be positive data to you and why? Thank you. Yeah, I mean, this is a short study. I think it's about 10
Speaker Change: Okay. Okay, and then last one is on <unk>, the depression asset Youre, having pulsatile data in 40 patients with MDT. Later this year can you just remind us how long the study is and what kind of Madras are hamdi efficacy benefit you want to see.
Andrew Tsai: And then last one is on A-20, the depression asset you're having pulsatile data in 40 patients with MDD later this year. Can you just remind us how long this study is and what kind of mattress or handy efficacy benefit you want to see at the end of the study? What would be positive data to you and why? Thank you. Yeah, I mean, this is a strong study. I think it's about 10 days' treatment, so it's not a very long study. It is open label about 40 patients. So we're targeting. So we think we have a very good chance.
Speaker Change: At the end of the study.
Speaker Change: The positive data to you and why thank you.
Unknown Participant: Yeah, I mean, this is a short study. I think it's about 10 days of treatment. So it's not a very long study. It is open label, about 40 patients that we're targeting. So we think we have a very good chance we will be able to record before year end.
Ed: Yes. This is Ed.
Ed: Study.
Unknown Participant: And as far as, I mean, the number of or the reduction in the scales and what would we expect? Of course, the larger the better, especially that it is open label. So we would hope to see certainly a large improvement on mattress versus if it were a placebo.
Andrew Tsai: We will be able to report before year end. And as far as the number of the reduction in the scales and what would we expect? Of course, the larger, the better, especially that it is open label. So we would hope to see certainly a large improvement on mattress versus if it were placebo control. Thanks again.
David Amsellem: Thank you. Our next question comes from David Anselam of Piper Sandler.
David Amsellem: Your line is now open. Thanks. A couple of questions on Calbury. So, with the back to school season coming up, help us understand your expectations for acceleration in volumes, particularly with the different gross to net framework that you've been talking about. And also in the context of, I believe last week, last back to school season, the Rx growth was, or acceleration was a bit muted. So help us understand how you're thinking about this year's back to school season. That's number one. And then number two is the, how much of the growth, you know, through the back half of the year, is the year-on-year growth is, is volumes.
David Amsellem: And how much of it is improvement in gross to net? And just help us better understand how we should be thinking about Calbury.
Ed: How we should be thinking about.
Speaker Change: Calgary is in other words, what I guess I'm trying to get at is.
Jack Khattar: In other words, what I guess I'm trying to get at is, is Calbury a volume growth product going forward, or is a lot of the growth that's being captured really just a function of improved economic scientists and then applied a bit, applied to this year, but also how are you thinking about the product beyond this year. Thanks. Yeah, I mean, there's an overall comment on the prescription growth of Calbury. I mean, as we mentioned in the first half, we provide about 28%. So we continue to expect to have robust growth in restrictions versus last year.
Ed: Is calgary.
Speaker Change: A volume growth product going forward or is a lot of the growth. That's being captured is it really just a function of improved economics. So that's just an implied apply to this year, but also how you're thinking about the <unk>.
Speaker Change: Product beyond this year. Thanks.
Unknown Executive: Yeah, I mean, as an overall comment on the prescription growth of Galbraith, I mean, as we mentioned in the first half We grew by about 28%, so we continue to expect to have robust growth in prescriptions versus last year. As far as specifically the back-to-school seasons, you're absolutely right.
Ed: Yes.
Speaker Change: As an overall comment on the.
Ed: Descriptions.
Speaker Change: I mean, as we mentioned in the first half.
Ed: We grew by about 28%. So we continue to expect robust growth in prescriptions versus last year.
Jack Khattar: As far as specifically the back to school seasons, you're absolutely right. Last year, overall, the market, the ADHD market, there was a much softer back-to-school season than normally we would see. And actually looking at the year-to-date ADHD market growth this year so far, it's up 8% in 2024 year-to-date in the first half of this year versus 2023. And if you might remember, the ADHD market grew only by 3% in 2023 in total. So this year already is showing a recovery in the market and the overall market in general, at least in the first half of 2024, at a much higher growth rate than last year.
Ed: As far as specifically the back to school seasons, you are absolutely right last year overall the market. The ADHD market there wasn't much software back to school season than normally we would see.
Unknown Executive: Last year, overall, the market, the ADHD market, there was a much softer back-to-school season than normally we would see. And actually, looking at year-to-date ADHD market growth, this year, so far, it's up 8% in 2024, year-to-date, in the first half of this year, versus 2023. And if you might remember, the ADHD market grew only by 3% in 2023 in total. So this year already is showing a recovery in the market, in the overall market in general, at least in the first half of 2024, you know, at a much higher growth rate than last year.
Ed: And actually looking at year to date ADHD market growth.
Ed: This year, so far and it's up 8% in 2000 2040 years to date in the first half of this year.
Ed: Versus 2023.
Ed: And if you might remember the ADHD market grew only by 3% in 2023 in total so this year already is showing.
Jack Khattar: So I'm hoping that the back to school season would be back to what normal growth would be versus what happened in 2023. I mean, in 2023, we actually saw some decline actually in the ADHD market with the measurement that we talked about it back then, which was June through September. It was not necessarily a calendar quarter to get a better feel for what happened in the back to school. While the recovery continued to grow last year and it grew by about 19% in the back to school season. So I'm hoping that the market does better.
Unknown Executive: So I'm hoping, you know, that the back to school season would be back to what normal growth would be versus what happened in 2023. I mean, in 2023, we actually, you know, saw some decline, actually, in the ADHD market, with the measurement that we talked about it back then, which was June through September, you know, was not necessarily a calendar quarter to get a better feel for what happened in the back to school while recovery continued to grow last year, and it grew by about 19% in the back to school season.
Unknown Executive: So I'm hoping that the market does better. And, of course, that means we will also do better than we did last year as far as growth is concerned. But the short answer, I mean, to your question is, the growth in calories is not just an improvement in gross net, certainly; we continue to have robust growth. I mean, we're already in year four as far as the launch of this product, and we're still delivering 20% plus growth in prescriptions.
Jack Khattar: And of course, that means we will also do better than we did last year as far as growth. But the short answer and a dear question is, the growth in Calvary is not just improvement in growth. And that certainly we continue to have robust growth. I mean, we're already in year 4 as far as the launch of this product. And we're still delivering 20% plus growth in restrictions.
Unknown Executive: And from a penetration perspective, we still have a lot of room to go here, as far as the potential of this product and its penetration in the market, adult and pediatric at the same time. Hopefully that touches on all the questions.
David Amsellem: And from a penetration perspective, we still have a lot of room to go here as far as the potential of this product and its penetration in the market, adult and pediatric at the same time. Yeah, and if I just make sneak in a quick follow up, the gross to net, I mean, it's, you know, getting below 50%, I mean, which is, you know, better than what you had cited as a target in the past. I mean, is that 45% to 50%, you know, and just to be clear, that's your view of steady state gross to net over the long term for the product? Or, and maybe I'll ask it differently, is there room for, you know, even further improvement?
Unknown Participant: Yeah, and if I just make sneaking a quick follow up, the gross net, I mean, it's, it's, you know, getting below 50%, I mean, which is you know, better than what you had cited as a target in the past. I mean, is that 45 to 50%? You know, and just to be clear, that that's your view of steady state gross net Over the long term for for the product or and maybe I'll ask it differently. Is there room for, you know, even further improvement?
Speaker Change: Ah is a target in the past I mean is that 45% to 50%.
Speaker Change: And just to be clear that that's your view of steady state gross to net.
Speaker Change: Over the long term for the product or and maybe I'll ask it differently is there room for even further improvement.
Jack Khattar: Yeah, I mean, what I heard in my prepared remarks, which was the actual return, just to explain it a little bit more. Typically, when you first launch a product, you know, you make an assumption on how much of these initial batches that you ship out, you know, how much of those could potentially come back at some point from a return perspective. And you book it; you know, you enter, you know, in your books, as far as potential liability, a crewals would have you on these returns. And then, as time goes on, these batches will either be consumed or they expire because time goes on and they have a certain fixed expiration date.
Speaker Change: Yes.
Speaker Change: When I spoke to in my prepared remarks, which was the original three times just explain that a little bit more typically when you first launch a product you make an assumption on <unk>.
Speaker Change: Much of these initial batches that you ship.
Speaker Change: How much of those could potentially come back at some point from a return perspective.
Unknown Executive: And you book it, you know, you enter it in your books as far as potential liability, accruals, what have you on these returns. And then, as time goes on, these batches will either be consumed, or they expire because time goes on, and they have a certain fixed expiration date. So as they approach or go beyond the expiration date, basically, they're not going to be returned anymore.
Speaker Change: That you booked it.
Speaker Change: You entered.
Speaker Change: Books as far as potential liability accruals what have you on lease returns and then as time goes on these batches.
Speaker Change: We'll either be consumed or they expire because time goes on and they have a certain fixed exploration date, so as they approach or go beyond the expiration date basically that I'm not going to be returned anymore, but if you do have much lower experienced from a return perspective versus the initial assumption.
Jack Khattar: So, as they approach or go beyond the expiration date, basically, they're not going to be returned anymore. Or if you do have much lower experience from a return perspective versus the initial assumption, that's one you can, you know, take back some of that. So these are things that could potentially continue that way. I mean, there is a possibility we continue to benefit from that trend in the next quarter or so. So it may not be at one time, but we can only see that when we get the data, you know, every quarter. And therefore, to back to your question on an ongoing basis, with the target be 45 to 50, I sure hope so.
Unknown Executive: Or if you do have much lower experience from a return perspective versus the initial assumption, that's when you can, you know, take back some of that. So these are things that could potentially continue that way. I mean, there is a possibility we continue to benefit from that trend in the next quarter or so. So it may not be at one time, but we can only see that when we get the data, you know, every quarter.
Speaker Change: You can take back some of that.
Speaker Change: So these are.
Speaker Change: These are the things that could potentially continue that way.
Unknown Executive: And therefore, back to your question: on an ongoing basis, would the target be 45 to 50? I sure hope so. I mean, I sure hope that next quarter gives us even more confidence. And in that case, we will, you know, emphasize or confirm that that probably is our long-term target versus the 50 to 55 percent. Okay, that's helpful. Thank you.
David Amsellem: I mean, I should hope that next quarter gives us even more confidence. And in that case, we will, you know, we will emphasize or confirm that that probably is our long term target versus the 50 to 55%. Okay, that's helpful. Thank you.
Stacy Ku: Our next question comes from Stacy Kuh of TD Cohen. Your line is now open.
Operator: Our next question comes from Stacy Ku of TD Cohen, your line is now open.
Stacy Ku: wonderful. Thanks so much for taking our questions. What a great quarter for Calgary and just so solid that value for the prescription. So we have a few follow-ups. Just for Q1, can you just talk a little bit more about what you're trying to do to grab share in the back-to-school season? So just to clarify, you said the next quarter or so you could see a benefit in gross NETs, but do you think any of these back-to-school plans could impact gross NETs in Q3?
Stacy Ku: Wonderful.
Stacy Ku: Thanks so much for taking our questions. Let a great quarter for Calgary and just follow that value for prescription. So we have a few follow-ups.
Stacy Ku: Just for Q1, can you just talk a little bit more about what approach you're trying to do to grab share in the back of school season? So just to clarify, you said the next quarter or so, you could see a benefit in grossenets. But do you think any of these back to school plans could impact the grossenets in Q3?
Stacy Ku: So this is the first question. And then to ask the question a little bit differently, how do you think about your comfort with the 200 and 220 million consensus rates for Calgary that you've kind of commented on in the past? Could this be exceeded as we think about just the solid gross NET improvements? And then last question is on the adult growth. Talked about the 32% split, but is this driving the NET pricing? Are you seeing kind of encouraging growth? And how should we think about the remainder of the year as you think about really trying to drive that adult launch as well? Thank you so much.
Stacy Ku: So this is the first question. And then to ask the question a little bit differently, how do you think about your comfort with the 220 million consensus rates for Calgary that you've kind of commented on in the past? Could this be exceeded as we think about this, the solid grossenets improvements?
Stacy Ku: And then last question is on the adult growth. Talked about 30% split. But is this driving the net pricing? Are you seeing kind of encouraging growth? And how should we think about the remainder of the year as you think about really trying to drive that adult launch as well?
Jack Khattar: Thank you so much. Yeah, on the first question, the back-to-school programs, it's fairly intense as far as the level of support that we will be going out with and the momentum that we will be building and hard-building actually as we speak right now in preparation for the back-to-school season. So we will put a lot of investment and effort behind the season, given the importance of the season for the whole year for the brand in general. At the same time, we're not neglecting the adult portion of the business, of course, in Q3, but the top priority is cleaning children and pediatric because of the back-to-school.
Speaker Change: In general at the same time, we're not in.
Speaker Change: Collecting the adult side again, a portion of their business of course in Q3, but the top priority.
Speaker Change: Clearly.
Speaker Change: Children in pediatrics because of the back to school.
Jack Khattar: As far as the annual sort of speech-soft guidance or whichever way you want to describe it, the 200-220, I mean, cleaning the first six months with 101 or 4.5 or 105, double that is 2.10 and of course, you've got to add some growth to it so clearly, we feel comfortable with that range. Is it going to be a little bit closer to the range? Hopefully, again, it all depends on the back-to-school season, which was a lot of what we've been talking about today. If the back-to-school season has really strong this year and not soft like it was last year, maybe we will be closer to the upper end of that range on Calvary.
Speaker Change: As far as the.
Unknown Executive: annual, you know, so to speak, soft guidance or whichever way you want to describe it, the 200 to 220. I mean, clearly in the first six months, we did 104.5 or 105.
Speaker Change: Annual.
Speaker Change: So to speak soft guidance, but whichever way you want.
Speaker Change: Describe the 200 to 220 are included in the first six months, we did 100 $104 five or 105.
Speaker Change: Double that has 210 and of course, you've got to add some growth to it. So clearly we feel comfortable with that range is it going to be a little bit closer to the upper range of hopefully again it all depends on the back to school season, which was a lot of what we've been talking about today of the back to school season is really strong this year and not <unk>.
Speaker Change: <unk> like it was last year maybe.
Speaker Change: Maybe we will be closer to the upper end.
Speaker Change: And of that range on caliber.
Jack Khattar: And then finally, in the first, in this past quarter, in the second quarter, to give you an idea about our adult prescriptions or business, grew by about 26%. The pediatric grew by about 22% to 23%. So we had put some more emphasis on the adult patient population in the second quarter as time. So we are experiencing a little bit more growth in adult, but again, on a quarter-to-quarter basis, as I mentioned earlier or in previous calls, sometimes we on purpose shift the emphasis one quarter versus another depending on the seasonality and the importance of that specific patient population.
Speaker Change: And then finally I mean in the first.
Speaker Change: And this past quarter in the second quarter to give you an idea.
Stacy Ku: Incredibly helpful.
Stacy Ku: Thank you.
Annabel Samimy: Our next question comes from Annabelle Samimi of Stifel.
Annabel Samimy: Your line is now open. Hi, thanks for taking my question, and great quarter on Calvary. I just want to put a finer point on the adult versus pediatric. To what extent is the adult population driving some of maybe the improved pricing? Obviously, they have higher doses, so potentially higher price point. And given that that's where a good chunk of the growth was and some of your efforts had been lying in that area, can you maybe share some of the feedback that you're getting from the adult population?
Annabel Samimy: Is this an area that you can continue to push back from the adults in terms of whether they're favoring a stimulant versus a non-stimulant? They're still transitioning with lower doses than you expected, et cetera, et cetera. I just try and understand why, with the growth that you have, why it's still sitting at 32% of your total prescriptions and also with the efforts that you're making last quarter, thanks. Yeah, regarding the price points and so forth. I'll just give you a couple of numbers. I mean, these are more gross numbers, but for the adult, I mean, we estimate the average blended cost of prescription is around $600, $615.
Unknown Executive: Yeah, regarding the price points and so forth, I'll just give you a couple of numbers. I mean, these are more gross numbers, but for the adult, we estimate the average blended cost of the prescription is around $600, $615. By comparison, it's around $525 for pediatrics. So there is about a 15, 17% difference between the price for a prescription for a pediatric versus an adult prescription, and that actually is, is obviously a result of the size of the prescription. So, with adults, you normally have 50 to 52 tablets per prescription or capsules per prescription. You know, with children, it's more around 44, or 45 capsules per prescription. So these are some of the metrics.
Jack Khattar: By comparison, it's around $525 for pediatric. So there is about 15 and 17% difference between the price for prescription pediatric versus adult. And that actually is obviously a result of the size of the prescription. So with adults, you normally have 50 to 52 tablets for prescription or capsules for prescription. You know, with pediatric. It's more around the 44 or 45. Capsules for prescription. So these are some of the metrics.
Jack Khattar: Obviously, it does change over time, quarter to quarter, but that's where we are right now as far as the, you know, pediatric versus adult. As far as the feedback on the adult patient population, I mean, very consistent, fairly consistent with the pediatric about the product, its performance, clinical benefits, all of the above power ability and safety. I mean, very, very consistent across all patient populations with both of them, you know, showing the growth and acceptance of the product. And by no means have we are even anywhere close to saturate, you know, the saturation as far as our penetration rates, I mean, our market share and adult is very low.
Patrick: Patrick versus adult.
Unknown Executive: Obviously, it does change over time, quarter to quarter, but that's where we are right now as far as the, you know, pediatric versus adult. As far as the feedback on the adult patient population, I mean, very consistent, fairly consistent with the pediatric about the product, its performance, clinical benefits, all of the above, the tolerability and safety, I mean, very, very consistent across all patient populations with both of them, you know, showing the growth and acceptance of the product.
Speaker Change: As far as the feedback on the adult patient population I mean, very consistent fairly consistent with the pediatric above.
Speaker Change: About the product and its performance clinical benefits all of the above.
Speaker Change: The power ability and safety I mean, very very consistent across all patient populations with both of them showing the growth and acceptance of the product.
Unknown Executive: And by no means we have, we are even anywhere close to saturate, you know, to saturation as far as our penetration rates. I mean, our market share in adult is very low, and we have a, you know, we have a huge, huge opportunity here for us to continue to push the product. And again, as long as the product continues to perform, you know, we see no reason for it to slow down and try to get a much higher market share penetration within the adult sector.
Speaker Change: And by no means we have we are even anywhere close to saturate the saturation as far as our penetration rates I mean, our market share in adult is very low and we have a we have.
Jack Khattar: And we have a, you know, we have a huge, huge opportunity here for us to continue to push the product. And again, as long as the product continues to perform, you know, we see no reason for it to slow down and try to, you know, get a much higher market share penetration within the adult segment.
Patrick: A huge huge opportunity here for us to continue to push the product and again as long as the product continues to perform we see no reason for it to slow down.
Speaker Change: And try to get a much higher market share penetration within the adult segment.
Jack Khattar: Got it. And maybe you can just share what your expectations are for the level of penetration you might have in that adult population. And you're, you know, either for the year or for the long-term outlook, is this still going to be a 32% type of, well, I mean, is it going to account still for about 32% of your prescriptions? Or do you expect that number to continue to go up through the year? Yeah, we do expect it to go up eventually, whether through this year or next quarter or whatever, but more on a long-term basis, definitely we would expect, and we certainly will be working pretty hard, you know, to get that portion to be a bigger part of the mix.
Speaker Change: Got it and maybe you can just share what your expectations are.
Speaker Change: For the level of penetration you might have in that adult population and your you know either for the year or for the long term outlook.
Speaker Change: Still going to be a 30, 32% type of.
Unknown Executive: Well, I mean, is it going to still account for about 32% of your prescriptions, or do you expect that number to continue to go up through the year?
Speaker Change: Well I mean is it going to account for about 32% of your prescriptions or do you expect that number to continue to go up through the year.
Unknown Executive: Yeah, I mean, we do expect it to go up eventually, whether through this year or next quarter or the quarter after, but more on a long term basis, definitely we would expect and we certainly will be working pretty hard, you know, to get that portion to be a bigger, you know, part of the mix. So will Calgary end up being a 40% adult and 60% pediatric where the market is pretty much 67% adult and 33%, you know, pediatric.
Speaker Change: Yes.
Jack Khattar: So will tell me end up being a 40% adult and 60% pediatric where the market is pretty much 67% adult and 33% you know, pediatric probably, I mean, we are a non stimulant anyway in general. So you are going to have some bias of the business being a little bit more pediatric than adult in general, generally speaking. But certainly, you know, we are pushing pretty hard to get that 32% much higher as being part of the mix. And, you know, as far as the adult in general, as I mentioned earlier, I mean the satisfaction, the performance, everything is very similar to what we're seeing with the pediatrics.
Unknown Executive: Probably, I mean, we are a non-stimulant anyway, in general, so you are going to have some bias against the business being a little bit more pediatric than adult in general, generally speaking. But certainly, you know, we are pushing pretty hard to get that 32% much higher as being part of the mix. And, you know, as far as adults in general, as I mentioned earlier, I mean, the satisfaction, the performance, everything is very similar to what we're seeing with pediatrics.
Unknown Executive: So we see no reason why we shouldn't be able, you know, to continue to grow within the adult market. At this point, our market share within the adult market is around 0.3% in pediatrics. We're in the 2%, you know, give or take. So we, you know, we continue to look for the whole brand Calgary. You might remember we talked about somewhere between 4-5% market share or could be as high as 10% market share of the total ADHD market. So we clearly have a long way to go here with Calgary. Okay.
Jack Khattar: So we see no reason why we shouldn't be able, you know, to continue to grow within the adult market. At this point, our market share within the adult market is around 0.3%. In pediatrics, we are in the 2%, give or take.
Jack Khattar: So we, you know, we continue to look for the whole brand calibrate. You might remember we talked about somewhere between 4% or 5% market share or could be as high as 10% market share of the total age of the market. So we clearly have a long way to go here with health.
Unknown Participant: Okay, if I can just ask a quick question on SPN 830. I guess this has happened several times now through the review process. Are there any indications from FDA on the breadth of the population that might be included in the label? I'm not sure if you ever got to that point where you got to label discussions, but is FDA considering a broader label, or is it still mostly in the severe camp? Thanks.
Annabel Samimy: Okay. And if I can just ask a quick question on SPN 830, I guess this is several times now through the review process. Are there any indications from the FDA on the breadth of the population that might be included in the label? I'm not sure if you ever got to that point where you got to label discussions, but is FDA considering a broader label or is it still mostly in the severe camp? Thanks.
Jack Khattar: Yeah, I mean, at this point, it is really premature for us to make any comment on that because we haven't gotten that far as far as discussions. So we really don't know at this point.
Unknown Executive: Yeah, I mean, at this point, it's really premature for us to make any comment on that because we haven't gotten that far as far as discussions go, so we really don't know at this point.
Unknown Executive: Okay. Great.
Unknown Executive: Thank you.
Jack Khattar: This concludes the question and answer session.
Jack Khattar: This concludes the question and answer session. I would now like to turn it back to Jack Khattar for closing remarks.
Jack Khattar: I would now like to turn it back to Jack Khattar for closing remarks. Including our call this afternoon. We thank you for joining us to learn about our strong performance and the second quarter and the first step of this year. The company continues to execute remarkably well through a multi transition and the loss of exclusivity on two of its legacy products. The company has generated strong positive cash flows behind the strength of its portfolio, particularly our growth products and the efficiency of its operations. In addition, we are excited about our progress on the pipeline across several programs. These programs will be generating significant data over the next six to twelve months.
Jack Khattar: In concluding our call this afternoon, we thank you for joining us to learn about our strong performance in the second quarter and first half of this year. The company continues to execute remarkably well through a multi-year transition and the loss of exclusivity on two of its legacy products. The company has generated strong positive cash flows behind the strength of its portfolio, particularly our growth products and the efficiency of its operations. In addition, we are excited about our progress on the pipeline across several programs. These programs will be generating significant data over the next 6 to 12 months. Thanks again for joining us this afternoon. We look forward to updating you on our next call.
Jack Khattar: Thanks again for joining us this afternoon. We'll forward updating you on our next call.
Unknown Executive: Thank you for your participation in today's conference. This does conclude our program.
Operator: Thank you for your participation in today's conference. This does conclude our program. You may now disconnect.
Unknown Executive: You may now disconnect.