Q2 2024 Eton Pharmaceuticals Inc Earnings Call
Speaker Change: Good afternoon and welcome to the Eton Pharmaceuticals second quarter 2024 financial results conference call.
Speaker Change: At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions.
Speaker Change: Please be advised, this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.
David Krempa: Good afternoon, everyone, and welcome to Eton's second quarter 2024 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com.
Speaker Change: Joining me on our call today, we have Sean Brynjelsen, our CEO , and James Gruber, our CFO . In addition to taking live questions on today's call, we will be answering questions that are emailed to us. Investors can send their questions to InvestorRelations at etonpharma.com.
Speaker Change: Before we begin I would like to remind everyone that remarks made during this call may contain forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements.
Speaker Change: Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC.
Speaker Change: Now, I will turn the call over to our CEO, Sean Brynjelsen.
Sean Brynjelsen: Thank you, David. Good afternoon, everyone, and thank you for joining us today.
Sean Brynjelsen: We are pleased to be reporting yet another quarter of record product sales.
Sean Brynjelsen: Eton began 2024 with high expectations across all areas of the business, and now that we've reached the midpoint of the year, I'm proud to say we're executing on all fronts. We've continued to rapidly grow sales of our existing commercial products, while also delivering on the advancement of our pipeline products.
Sean Brynjelsen: most notably ET-400, and we were able to do all of this while generating positive cash flow from operations in the second quarter.
Sean Brynjelsen: I could not be happier with our corporate performance so far this year.
Sean Brynjelsen: The second quarter was Eaton's 14th straight quarter of sequential product sales growth.
Sean Brynjelsen: We are very proud of this streak, and based on our portfolio's long runaway for growth, we expect this streak to continue for the foreseeable future.
Sean Brynjelsen: Product sales increased 40% year-over-year to 9.1 million in the quarter and grew 14% over the previous high in the preceding quarter.
Sean Brynjelsen: Absent any unannounced M&A transactions, we expect to reach positive GAAP net income by the end of this year.
Sean Brynjelsen: These impressive results were primarily due to continued strength from both of our lead products, alkindesprinkle and cargolimic acid.
Operator: 2024 Financial Results Conference. At this time, all participants are in a listen-only mode.
Sean Brynjelsen: Elkindy Sprinkle saw its growth accelerate in the second quarter as we have seen a strong uptick in the number of new patient referrals received this year.
Operator: Following the formal remarks, we will open the call up for your questions. Please be advised, this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals.
Sean Brynjelsen: Al-Kindi revenue increased an impressive 63% year-over-year. Given that Al-Kindi is our highest margin product and one which we believe has the largest market opportunity, we are very pleased to see this acceleration of growth.
Sean Brynjelsen: Sales are benefiting from several key initiatives, including our team's strong presence at endocrinology medical conferences during the first half of the year, the initiation of our sampling program and the improved productivity of our internal sales force.
Sean Brynjelsen: I don't expect any difference from the pilot study to the pivotal study. The main difference in design is the number of patients. So if you want a pilot and you want a fair number of patients, which we did, we don't expect that to be statistically different from the pivotal study because it was spot on in terms of the results.
David Krempa: Good afternoon, everyone, and welcome to Eton's second quarter 2024 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com. Joining me on our call today are Sean Brynjelsen, our CEO, and James Gruber, our CFO. In addition to taking live questions on today's call, we will be answering questions that are emailed to us.
Sean Brynjelsen: I think that may be the gating item because, in terms of filing it, but we expect that to be filed in the first quarter of 2035. And as we kind of think about commercial preparation before the potential ET-400 launch, have you given any thought to any additional resources in the sales force? Any additional heads there?
Sean Brynjelsen: And then how soon after potential approval at the end of February would you expect to launch the drug? So we are currently happy with the size of our sales force. We have 12 reps. We are open to adding additional reps for the ET-400 launch. I don't know that it will be necessary, but that's something that we'll decide. If it is necessary, it would be kind of in the two to four range.
Sean Brynjelsen: We are now in the second year of having our full internal sales force in place and we are seeing the results of our team strengthening relationships that they worked hard to develop over the last 18 months in their respective territories.
Sean Brynjelsen: But at the moment, we have pretty good coverage on February 28th about the labeling of the product. Normally, the FDA provides the labeling of the product, but we don't have that. Really, it should happen shortly after approval. So let's say we get approval on February 28th. We will already have batches produced using commercial batches this year. They will be tested and released in March. Don't think that would be exciting because it could potentially be March; February 28th is the labeling date of the product.
Sean Brynjelsen: Eaton now has more than 400 active patients on therapy, and we estimate that this only represents 10% of the target market, so we still have a long ways to go.
David Krempa: Investors can send their questions to InvestorRelations at etonpharma.com. Before we begin, I would like to remind everyone that remarks made during this call may contain forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC... Now I will turn the call over to our CEO, Sean Brynjelsen. Thank you, David. Good afternoon, everyone, and thank you for joining us today.
Sean Brynjelsen: On the metabolic side of our portfolio, perglumic acid continues to strengthen. Once again, the product is exceeding our expectations, and we are happy with our performance. Perglumic posted record revenue. Eton now has more than 400 active patients. We have already added additional new patients in July . And we estimate that we only represent 10% of the target market.
Sean Brynjelsen: So sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU goal-like in March. And we have now fully re-launched the product with our clinical organizations, and we are happy with the performance. Patients who suffer from amino-positive record revenue in PKU, we have already added additional nucleation in July, and amino acids are on the approach to continue. In consumption of protein, sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU goal-like in March.
Sean Brynjelsen: Got it. And then just on BD, Sean, maybe speak to kind of the materiality of some of these deals we're pursuing and kind of how you're thinking about a potential fairly large transformative transaction for the company potentially by the end of the year or just kind of some general, more in-depth thoughts there. And then, just last for James.
Sean Brynjelsen: On the BD side, we are pursuing deals where late-stage products, identical commercial products, you know, are in progress, or anything that would give us $10 million or more in additional revenue, literally right out of the gate. So the size of the deal could be in the $20-$30 million range. On the BD side, you know, we are pursuing deals where late-stage products, you know, ideally commercial products, you know, are in progress, or anything that would give us $10 million or more in additional revenue, literally right out of the gate. So the size of the deal could be in the $20-$30 million range.
David Krempa: Good afternoon, everyone, and welcome to Eton's second quarter 2024 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com. Joining me on our call today are Sean Brynjelsen, our CEO, and James Gruber, our CFO. In addition to taking live questions on today's call, we will be answering questions that are emailed to us. Investors can send their questions to InvestorRelations at etonpharma.com.
David Krempa: Before we begin, I would like to remind everyone that remarks made during this call may contain forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statement disclaimer in our earnings release and the risk factors in the company's filings with the SEC. Now, I will turn the call over to our CEO, Sean Brynjelsen. Thank you, David. Good afternoon, everyone, and thank you for joining us today.
Sean Brynjelsen: We are pleased to be reporting yet another quarter of record product sales. Eton began 2024 with high expectations across all areas of the business. And now that we've reached the midpoint of the year, I'm proud to say we're executing on all fronts. We've continued to rapidly grow sales of our existing commercial products while also delivering on the advancement of our pipeline products, most notably ET-400. And we were able to do all of this while generating positive cash flow from operations in the second quarter. We could not be happier with our corporate performance so far this year. The second quarter was Eton's 14th straight quarter of sequential product sales growth.
Sean Brynjelsen: We are pleased to be reporting yet another quarter of record product sales. Eton began 2024 with high expectations across all areas of the business, and now that we've reached the midpoint of the year, I'm proud to say we are executing on all fronts. We've continued to rapidly grow sales of our existing commercial products while also delivering on the advancement of our pipeline products, most notably ET-400. And we were able to do all of this while generating positive cash flow from operations in the second quarter.
Speaker Change: and we're going to map this as we launch part-out on working organization in the U.S. And so I shall let you know what you're going to do about it. Also known as the P.P.A.U., go like the enzyme needed to break out, you go like in the destroying. And you know, actually, if I'm going to take the condition, it's not going to be a problem. I'm going to let you know that it's a regular protein, but we don't have to build that. And we've got that in those that we are actively dealing with on this other metabolic problem. That this, and that's to me, is eight. We also, you go like using, I think, last U.S.U.R.I. because it's why I'm writing a lot of protein-meting in the U.S.U.R., it's just P.P.A.U, because it's better tasting than the P.P.A.U.R.I. and as of the late release technology, the 90-key vision is made up of metal and metal and metal, and metal areas of time. The same health energy, the time, from behind, benefits, and we're actually going to go like on our other metabolic, metabolic financial upside. We also do go.
Sean Brynjelsen: I could not be happier with our corporate performance so far this year. The second quarter was Eton's 14th straight quarter of sequential product sales growth. We are very proud of this streak, and based on our portfolio's long runaway for growth, we expect this streak to continue for the foreseeable future. Product sales increased 40% year-over-year to $9.1 million in the quarter, and grew 14% over the previous high in the preceding quarter. Absent any unannounced M&A transactions, we expect to reach positive GAAP net income by the end of this year.
Sean Brynjelsen: We are very proud of this streak, and based on our portfolio's long runaway for growth, we expect this streak to continue for the foreseeable future. Product sales increased 40% year-over-year to $9.1 million in the quarter and grew 14% over the previous high in the preceding quarter. Absent any unannounced M&A transactions, we expect to reach positive GAP net income by the end of this. These impressive results were primarily due to continued strength from both of our lead products, Alkindy Sprinkle and Kergalumic Acid.
Sean Brynjelsen: Our sales team re-launched Go White at the GMOs, Eton has also continued to have big sites in the tan and the citronome. Although the revenue is drying for these two products, we have already seen an uptick in new clinical referrals since our promotional activity began. We continue to work towards our goal.
Sean Brynjelsen: These impressive results were primarily due to continued strength from both of our lead products, alkali sprinkle and cargolimic acid. Alkiddy Sprinkle saw its growth accelerate in the second quarter as we have seen a strong uptick in the number of new patient referrals received this year. Elkindi revenue increased an impressive 63% year over year.
Sean Brynjelsen: Alkiddy Sprinkle saw its growth accelerate in the second quarter as we have seen a strong uptick in the number of new patient referrals received this year. Elkindi revenue increased an impressive 63% year-over-year. Given that Alkindi is our highest-margin product and one which we believe has the largest market opportunity, we are very pleased to see this acceleration of growth. Sales are benefiting from several key initiatives, including our team's strong presence at endocrinology medical conferences during the first half of the year, the initiation of our sampling program, and the improved productivity of our internal sales team.
Sean Brynjelsen: Given that Alkindi is our highest-margin product and one which we believe has the largest market opportunity, we are very pleased to see this acceleration of growth. Sales are benefiting from several key initiatives, including our team's strong presence at endocrinology medical conferences during the first half of the year, the initiation of our sampling program, and the improved productivity of our internal sales force. We are now in the second year of having our full internal sales force in place, and we are seeing the results of our team's strengthening relationships that they have worked hard to develop over the last 18 months in their respective territories.
Operator: At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised, this call is being recorded at the company's request.
Speaker Change: Our goal is to reconfigure the interaction under the control of the estimated 400 million dollars and now offering aid to medical activity in the U.S. For most, P.K. U. Goal Life. He has also continued to add patient, turning to our involvement in this plan over the past although the revenue incurred me, this has got, I think, important, the significant money went into the year in the year, in the year 100. They have further sprived in our active employee-related medical life, like we've had on the four years of evolution. Increasing the previous four generations of the time-to-mails for patients, we'll make an alternative for turning our development pipelines over the past, potentially, several thousand per meter per person, the products of our pipeline candidate. Currently, these patients are either appropriating their own data formulae, whole major source of information in the world. First tablets with water. This formulae is an important part of the process.
David Krempa: At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.
Sean Brynjelsen: We are now in the second year of having our full internal sales force in place, and we are seeing the results of our team strengthening relationships that they have worked hard to develop over the last 18 months in their respective territories. Eton now has more than 400 active patients on therapy, and we estimate that this only represents 10% of the target market. So we still have a long ways to go.
David Krempa: Good afternoon, everyone, and welcome to Eton's second quarter of 2024 conference call. This afternoon, we issued a press release that outlines the topics we planned to discuss on today's call. The release is available on our website, EtonFarma.com.
Sean Brynjelsen: Eton now has more than 400 active patients on therapy, and we estimate that this only represents 10% of the target market, so we still have a long way to go. On the metabolic side of our portfolio, perglumic acid continues strengthening relationships, once again far ahead of schedule, exceeding our expectations.
Sean Brynjelsen: On the metabolic side of our portfolio, Perglumic Acid continues to shine. Once again, the product is exceeding our expectations, and we are happy with the performance. Perglumic posted record revenue in the past year, and we have already added additional new patients. And we estimate that this only represents 10% of the target market. So we stick with the metabolic portfolio. On the metabolic side of our portfolio, Perglumic Acid continues to shine. Once again, the product is exceeding our expectations, and we are happy with the performance.
David Krempa: Joining me on our call today, we have Sean Brynjelsen, our CEO, and James Gruber, our CFO. In addition to taking live questions on today's call, we will be answering questions that are emailed to us. Investors can send their questions to investorrelations at EtonFarma.com.
Sean Brynjelsen: Posting record revenue, he now has more than 400 employees.
Sean Brynjelsen: And we've always had it on daily, and we estimate that it's only revenue of 10% of the target.
Speaker Change: Patients, Therapists, and Physicians. During the second quarter, we completed our NDA submission for ET-400 to the FDA. Last month, we received the exciting news that the NDA was accepted for review.
Sean Brynjelsen: and Eton Pharmaceuticals Inc. Thank you.
Sean Brynjelsen: We are excited to announce the acquisition of PKU Golang in March, and we have now fully relaunched the product, meeting our expectations, and we are happy with the performance.
David Krempa: Before we begin, I would like to remind everyone that remarks made during this call may contain forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's violence with the SEC.
Speaker Change: We're thrilled to be one step closer to bringing this critical medication to patients in need. The FDA has established a water and food processing compounded product that is not FDA approved. And I have initiated the launch preparation activities according to the FDA. Last month we received exciting news that the NDA was agreed upon for review. We're thrilled to be one step closer to bringing this critical medication to patients in need.
Sean Brynjelsen: Patients who suffer from Perglumic Protein Merea, also known as PKU, lack the enzyme needed to break down phenylalanine, so we expect the revenue growth to continue. In terms of consumption of protein, sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU Golight this month. We have made this an estimated 8,000 PKU patients in the U.S. Patients who suffer from Perglumic Protein Merea, also known as PKU Golight, lack the enzyme needed to break down phenylalanine, so we expect the revenue growth to continue.
Sean Brynjelsen: Michael Ruddon and QTU, and we have already added a breakdown funnel to Allen.
Sean Brynjelsen: and Amino Acids. We expect the revenue growth to continue. Sticking with the metabolic portfolio, we were excited to announce the acquisition of A-cells in your gold-like population.
Sean Brynjelsen: In consumption of protein, sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU Golight this month. Patients who suffer from Perglumic Protein Merea, also known as PKU Golight, lack the enzyme needed to break down phenylalanine, so we expect the revenue growth to continue.
Sean Brynjelsen: Now, I will turn the call over to our CEO, Sean Brynjelsen. Thank you, David.
Sean Brynjelsen: in the U.S.
Sean Brynjelsen: U.S. Reliance on the Specialized Protein Area, also known as PSA
Sean Brynjelsen: Good afternoon, everyone, and thank you for joining us today. We are pleased to be reporting yet another quarter of record product sales. Eton began 2024 with high expectations across all areas of the business, and now that we've reached the midpoint of the year, I'm proud to say we're executing it all front, we've continued to rapidly grow sales of our existing commercial products, while also delivering on the advancement of our pipeline products.
Speaker Change: We have to prove that we've been in the F-400 world as a part of the act leader percentage of over $4.28 billion. We've also made up that a driver has been in the F-400 world. We've also made up that a driver has been in the F-400 world. We've also made up that a driver has been in the F-400 world. [inaudible]
Sean Brynjelsen: All of it. PKU-Gol-L is a strong and amino acid-protein compound.
Sean Brynjelsen: The condition is managed by Metabolic Geneticists, a regular approach to sustainable healthcare professionals
Sean Brynjelsen: In consumption of protein, sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU Golight this month. In addition to these compelling benefits, the acquisition of Golight offered meaningful financial upside. We also doubled revenue for the outset. Even though the Golight variety is still early in its launch with significant revenue, it was significantly better tasting than the competing product. In mid-April, our state-of-the-art re-launched Golight Genetic Metabolic Dietary International Conference.
Sean Brynjelsen: and other medical professionals that we are actively engaged with on our other metabolic products. We also use PKU patients in the U.S. because of the broad variety of formats, including unique formulas such as PKU Gold.
Sean Brynjelsen: Most notably, ET400. And we were able to do all of this while generating positive cash flow from operations in the second quarter. I could not be happier with our corporate performance so far this year. The second quarter was Eton's 14th straight quarter of sequential product sales growth. We are very proud of this streak and based on our portfolios' long runaway for growth, we expect this streak to continue for their foreseeable future.
Sean Brynjelsen: Panel Reviewed in 2013
Sean Brynjelsen: In addition to these compelling benefits, the acquisition of Golight offered meaningful financial upside, and we continue to work towards our goal of achieving 10% market share of the estimated $100 million market for PKU Medical Products. In mid-April, our sales team re-launched Golight at the Geneva Genetic Metabolic Dietary International Conference. And although revenue is strong for these two products, we have already significantly lowered the Perglumic acid referral since our promotional activities have begun.
Speaker Change: [inaudible]
Sean Brynjelsen: In mid-April, our sales team relaunched a
Sean Brynjelsen: Product sales increased 40% year-over-year to 9.1 million in the quarter and grew 14% over the previous high in the preceding quarter. Absent any unannounced M&A transactions we expect to reach positive gap net income by the end of this year. These impressive results were primarily due to continued strength from both of our lead products, Elkindy Sprinkle and Kerglumeg acid. Elkindy Sprinkle saw its growth accelerate in the second quarter as we have seen its strong uptick and the number of new patient referrals received this year.
Sean Brynjelsen: Eton has also continued to have patients from the 10th National Conference and received immediate instruction. We've already seen an uptick in new patient referrals since our first meeting.
Sean Brynjelsen: We've already seen an uptick in new patient referrals. We have further strengthened our relationship in a metabolic, genetic, and immune way. We continue to work towards our goal of achieving comprehensive interaction.
Sean Brynjelsen: And we continue to work towards our goal of achieving 10% market share potential of the estimated $100 million market for PKU Medical Products to promote PKU Golight. Eaton has also continued to add patients and training to our development pipeline over the past several quarters. You heard me discuss the importance of our pipeline less than it did each year.
Sean Brynjelsen: Elkindy revenue increased an impressive 63% year-over-year. Given that Elkindy is our highest margin product and one which we believe has the largest market opportunity, we are very pleased to see this acceleration of growth. Sales are benefiting from several key initiatives, including our team's strong presence at endocrinology medical conferences during the first half of the year, the initiation of our sampling program and the improved productivity of our internal sales. We are now in the second year of having our full internal sales force in place and we are seeing the results of our team's strengthening relationships that they worked hard to develop over the last 18 months in their respective territories.
Speaker Change: We remain focused on commercial assets in order for the company to be able to sell revenue and earn income. In addition to being our access account and our balance sheet, we believe we have significant additional capital available to us should we need it. Given our current stock price and relative opportunities, we remain optimistic about our ability to plan another product before U.S. We remain focused on commercial assets in order for the company to be able to sell revenue and earn income. In addition to being our access account and our balance sheet, we believe we have significant additional capital available to us should we need it. Given our current stock price and relative opportunities, we remain optimistic about our ability to plan another product before U.S.
Sean Brynjelsen: We will continue to add patients to our development pipeline. Although the revenue impact of these two products is significantly lower than the EC-400, they have further strengthened our relationship in the metabolic and endocrine solutions. Increasing the frequency of interaction is of high demand for patients, caregivers, and providers.
Sean Brynjelsen: They have further strengthened our relationship in the metabolic genetic oral solution. Increasing the frequency of interactions with high-demand-for-patient Perglumic acid prescribers is now offering an additional opportunity to promote PKU Golight and provide an alternative for the larger development pipeline over the past several quarters. You heard me discuss the importance of our pipeline candidates.
Sean Brynjelsen: and Sunil, and they've approved it...
Sean Brynjelsen: to promote DKU's goal of turning to our development pipeline over the past several quarters and currently discussing the importance of our pipeline candidates.
Sean Brynjelsen: Currently, these patients are either procuring their own home-made suspended-zone oral pressure tablets with water or using a compounded product that is not FDA approved. During the second quarter, we concluded our NDA submission for ET400 to the FDA. Last month, we received the exciting news that the NDA was accepted for a local product. We're thrilled to be one step closer to bringing a critical medication to patients in need.
Sean Brynjelsen: Currently, these patients are either providing their own patented formulation of hydrocortisone oral solution or using a high-demand-for-patient Perglumic acid prescribers. During the second quarter, we completed our NDA submission for ET400 to the FDA. Last month, we received the exciting news that the NDA was accepted for a limited product. We're thrilled to be one step closer to bringing a critical medication to patients in need. The FDA has assigned our application a due-for-target action date of February 28, 2025. During the second quarter, we completed our NDA submission for ET400 to the FDA.
Robert Marks: Director. As you saw was a record product sales for the quarter. As we were at the percent of all of the year, Robert Marks had made a spectacular line to tell you about the industry model future of the coming quarter. Secondly, we are rapidly a late stage collection of points, and I said our future is significant. Very bright and a long term question. If you're on our three starting with the main energy. A long term. A long term. If you're on our three starting with the main energy. A long term. A long term. A long term. A long term. A long term. A long term. A long term. [inaudible]
Sean Brynjelsen: Last month, we received the exciting news that the NDA was accepted for a limited product. We're thrilled to be one step closer to bringing a critical medication to patients in need. Once approved, we believe ET400 will also capture a greater percentage of the oral hydrocortisone market, and I have initiated and launched preparation activities of more than 50 million units annually. As you know, we are very excited about this product's potential. We expect to be in a position to launch ET400 quickly, participate in approval, and be at a major inflection point in 2025.
Sean Brynjelsen: The FDA has assigned our application to the PDUFA Targeted Action Data of February 28th, 2025, and I have initiated and launched our ODS Submission for E-400 to the FDA.
Sean Brynjelsen: to the FDA. Last month, we received the exciting news that the NDA was expected to launch EG 400. We are thrilled to be one step closer.
Sean Brynjelsen: Once approved, we believe ET400 will also capture a greater percentage of the oral hydrocortisone market, and together with Alkindi Sprinkles, we believe ET400 can contribute to and combine sales of more than 50 million annually. As you know, we are very excited about this product's potential. We believe ET400 will also capture a greater percentage of the oral hydrocortisone market. We expect to see ET400 launch early in 2025, a major inflection point in 2025.
Sean Brynjelsen: Once approved, we believe C400 will allow us to capture a greater percentage of the world's hydrocortisone market, together with Alkindy Spraysilk, the chain's combined team of
Sean Brynjelsen: projects. Thank you.
Sean Brynjelsen: [inaudible] our full internal sales force in place and we are now having our full internal sales force in place and we are now having our full internal sales[inaudible] our full internal sales force in place and we are now having our full internal sales force in place and we are now having our full internal sales force in place[inaudible] In addition to all some growth in our commercial products in the near term, our product plan is under development. We continue to work for today's growth and business development.
Speaker Change: We are optimistic about our prospects to acquire new products in business development, which could further our charge on our growth and provide a major boost for profit growth. With the combination of these three levers, I believe we have a great opportunity to achieve our goal of reaching $100 million in revenue in the coming years. With that, I'll turn it over to James, Chief Financial Officer, to discuss the financial future. James? Thanks, Sean. James?
James: increased 40% to $9.11 million compared to $6.50 million prior to the second quarter of 2023, which included $0.6 million in non-recurring royalties to $5.5 million. The second quarter product sales revenues were driven primarily by growth in our Neurology product Royals and carglumic acid.
Sean Brynjelsen: In addition to growth from our commercial products in the near term, our product line candidate is under development. We continue to pursue opportunities for growth in business.
Sean Brynjelsen: In addition to growth from our commercial products in the near term, our product candidate is under development, and we continue to pursue opportunities for growth in business development. We believe we are in a very effective position to do this. We have a healthy balance sheet generating cash, and our product sales are going to continue to grow for many years to come. As a result, we have the luxury of being able to bring in patients to grow from our commercial product in the near term. Our product candidate is under development, and we continue to pursue opportunities for growth in business development.
Sean Brynjelsen: We believe we are in a very effective position in which to do this. We have a healthy balance sheet generating cash, and our product sales are going to continue to grow for many years to come. As a result, we have the luxury of being able to bring in patients to grow from our commercial product in the near term; our product candidate is under development, and we continue to pursue opportunities for growth in business development.
Sean Brynjelsen: and John M. Kessler. Thank you. We have a healthy and pivotal study in the next couple months. We expect to submit the NDA early in 2025 for potential approval and come out a little later. In addition, to grow from our
James: Net product sales and royalty revenues for the second quarter of 2024 increased 40% compared to the first quarter in 2024.
Speaker Change: And as Sean mentioned, we expect product sales to continue to grow into $0.6 million throughout the rest of this year and beyond.
Sean Brynjelsen: and Oracle Product and New Opportunities Pipeline Candidates. While we certainly don't need new opportunities to grow business in order for the company to be self-sustaining,
Speaker Change: [inaudible] Product sales, the 23.1 million in 2.4 million in per cent, one time in various versions of the 20.2 million people or 100. And as Sean mentioned, absent of any of you, that's probably all the other end. And you're growing quarter-eight. We're back with R&DX, throughout the rest of the return here, it's a recent historic levels.
Sean Brynjelsen: We are in a very tragic situation in which...
Sean Brynjelsen: are in for a very attractive return by putting money to work in commercial rare disease products that are a strong strategic threat for many years to come.
Sean Brynjelsen: These are not Vietnamese products that are on the table. These are Vietnamese medicinal oils.
Speaker Change: R&D expenses for the quarter were $3.0 million. General and administrative expenses for the quarter were $1.1 million and were $5.6 million, compared with the four payments of the $2.0 million period, due primarily to increased sales and marketing expenses related to the BC ECO-Lite commercial development transactions, as well as one-time R&D expenses associated with return to its recent historic levels,
Sean Brynjelsen: In addition to the accounts on our balance sheet, we have significant additional capital available to us as should we.
Sean Brynjelsen: We believe we have significant additional capital available to us should we need it. Given our current stock price relative to our near and long-term expectations, we remain optimistic about our ability to land another product in four years for any larger transaction. We remain focused on commercial assets.
Sean Brynjelsen: We are actively engaged in discussions relative to our near and long-term expectations for the business about our ability to land another product like Staph for any larger transaction. We remain focused on commercial assets to immediately deliver it to our customers.
Robert Marks: and the second half of the year.
Sean Brynjelsen: As we wrap up the call, I hope my remarks have made it clear why I am excited about EANS's projects in the coming quarters. We are rapidly nearing a critical inflection point, and I believe our future will be very bright as we execute on our current stock price relative to our near and long-term expectations for the business. Our strong products are firing on all cylinders, as you saw with the record product sales for the quarter.
Robert Marks: [inaudible]
Sean Brynjelsen: The Court I just after the administrative report came forth the reporting. I continue to report to check English ltd. I will do that that same day. I have governmental matters to inform me whether I am politically clear, and I do think we need precise answers to the appropriate passage to get our board in force. Obviously, I must re-ridership for the second session of the buying matters committee to allow following a reasonable principal after.
Sean Brynjelsen: All of us will be very bright as we execute our current stock price growth strategy. First, grow our existing products. Our strong products are firing on all cylinders, as we saw with the record product sales for the quarter and 40% year-over-year growth. We expect we are going to continue to grow this cross-future over the coming quarters.
Speaker Change: Comments for Basic, 2.9 million for the course and the pricing of your career, the 2.0 million E.T. 4.5 second quarter, with a pair of net income 7.0.6, and a pair of your generated 1.25 million Royal Student Health Board of Surgery.
Sean Brynjelsen: As we wrap up the call, I hope my remarks have made it clear why I am excited about EANS projects over the coming quarters. Secondly, we are rapidly nearing a critical inflection point, and I believe our future will be very bright as we execute on our three-point growth strategy. Until the launch of ET-400 in early 2025, these products are firing on all cylinders, as you saw with the record product sales for the quarter.
Sean Brynjelsen: Thank you very much.
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Speaker Change: We remain confident that our cash position is sufficient to allow us to execute our plan and continue pursuing results on transactions and new product development in the prior year period. This concludes our remarks on the second quarter of the zone and with a $17.7 million for cash on hand.
Sean Brynjelsen: of ET600 sales this year and 40% year-over-year growth. We remain optimistic about our prospects to acquire new products through business development, which could turbocharge our growth and provide a major boost to our business.
Sean Brynjelsen: Thirdly, we expect to notice continued prospects through business development, which could turbocharge our growth and provide a major boost to our profitability. With the combination of these three levers, I believe we have a great opportunity to achieve our goal of reaching $100 million in revenue in the coming years. With that, I'll turn it over to Jane, our Chief Financial Officer, to expand on how optimistic we are about our prospects to acquire new products. Thanks, Sean.
Sean Brynjelsen: Thank you all.
Speaker Change: and generated 1.3 million of operating cash during... Thank you. One moment while we compile the Q&A roster.
Speaker Change: and continue pursuing bolt-on transactions and new product developments.
Sean Brynjelsen: Officer to Thirdly, Fernando and Optimus to Game of Thrones.
Speaker Change: Your first question comes from the line of Chase Knickerbocker of Craig Hollum. Chase, please go ahead.
James Gruber: Our second quarter revenue was $9.1 million, compared to $12.0 million in the second quarter of 2023. The prior year period included $5.5 million in one-time licensing revenue related to the investment in our neurology product, Rhodiops.
Sean Brynjelsen: Our second quarter revenue was $9.1 million, compared to $6.5 million prior in our period, which included $0.6 million. Our second quarter revenue was $9.1 million, compared to $6.5 million prior in our period, which included $0.6 million. The prior year's recurring royalty revenue was $5.5 million.
Chase Knickerbocker: Good afternoon, guys. Thanks for taking the time. Thank you. One moment while we compile the Q&A. Maybe just talk about how the reception's been, kind of relative to your expectations.
James Gruber: Related to the investment in our Neurology Product Reliability.
Chase Knickerbocker: Your first question comes from the line of Chase Knickerbocker of Craig Collins. Chase, please go ahead. Good afternoon, guys. Thanks for taking the time. First, maybe I'll go, like, maybe just talk to how the reception's been, kind of relative to your expectations when you bought it, now that you've relaunched it and interacted with a lot of your physicians.
James Gruber: Our second quarter revenue was $9.1 million compared to $6.5 million prior to our period, which was at $0.6 million. In the prior year period, we got $5.5 million, a quarter-time high sales increase.
James Gruber: The second quarter product sales increase was driven primarily by growth in our technology product royalty and carglumic acid. Product sales also grew 1.1 percent in 2024, increasing 40% compared to the first quarter at $9.1 million. And as Sean mentioned, we expect product sales to continue growing quarter over quarter, non-recurring royalty revenue. In the second quarter, R&D expenses for the quarter were $3.0 million and $1.1 million in the prior year, with the increase due to the payment of a 2.0 million percent, one-time NDA submission period for 2400.
James Gruber: The second quarter product sales increase was driven primarily by growth in Alkindy Sprinkle and Carglumic Acid. Net product sales and royalty revenues for the second quarter of 2014 increased by 40% to $9.1 million. And as Sean mentioned, we expect product sales to continue growing to $0.6 million throughout the rest of this year and beyond. R&D expenses for this quarter were primarily due to growth in Alkindy Sprinkle and Carglumic Acid. Product sales also grew 1.1 million to 2.0 million; a one-time NDA submission for 2400.
Speaker Change: Physicians face-to-face, and they've been very excited to see the support behind the product again. And we've already seen an uptick in the number of referrals that we get on the product. We're still very excited about the product. The launching trajectory had lost a little bit of momentum. We started promoting it in mid-April. It's going to take a little bit to get back on a medium-width trajectory. Physicians face-to-face, and they've been very excited to see the support behind the product again.
Sean Brynjelsen: This project, we believe we are in a very active position on which to do we are we are helping balance the digital study generating cash months. And our product is to submit the FDA to grow for many years on the 5th potential. As a result, among the wider of being able to re-inhabit, in addition to growth from our industry product and new alternative type-line candidates, while we continue to work with new opportunities, growth and action in order for the company.
James Gruber: And as Sean mentioned, absent of any new business debt sales, the continued growing quarter of that quarter, throughout the rest of the year and beyond, R&D expenses for the quarter were $3.0 million, compared with $1.1 million in the prior year, with the increase due to the payment of a 2.0 million period, one-time NDA submission period for 2400, absence of any new commercial development transactions, the expected R&D expense to return to its recent storage levels General Administrative Expenses for the quarter were $5.6 million, ET400.
Chase Knickerbocker: And we've already seen an update on the number of referrals that we get off the product. So, we're still very excited about the product. We've still captured 10% of that $100 million market. It's just going to take us a little bit to get back on a strong footing, exactly, given that it wasn't going to happen overnight before we took over.
James Gruber: We're out the rest of return to these recent historic levels, and the second I'm going to be here is for the quarter. We're 3.1% of the administrative experts at this 1.1 million in the 5.1 years million, with the imperies to 4.8 million of them to 2.0 million. One time in primarily.
Sean Brynjelsen: We believe we are in a very do-actual position on which to do very try to help and balance the money to generating commercial rare product titles that are trying to continue to grow for many years to come. We are actively engaged in the development of all the opportunity.
James Gruber: is related to the absolute medical, like Mercell and Transaction, as well as one time, I think Lauren E.Ex. that is associated with returning to its recent historic levels.
Chase Knickerbocker: of
Sean Brynjelsen: Remain early in October 2010, as we bought our ability to land another product before year-old, we certainly don't, we remain focused on the current plans in order for the immediately delivered of revenue and are we new to the opportunities to earn energy. In addition to the current success from now on in our balance sheet, in commercially-reduced, significant additional discount will available to us at should we need it. We are actively giving our current scotch rice from all over the world to our beer and all you can make to move the business about our product. We are actively giving our opportunity to launch your transactions. We remain focused on commercial assets.
Speaker Change: got it. Maybe I'll do my own creation that's in place in every growing quarter year on about, you know, kind of another couple of things that we've added. Yeah. Maybe you just speak in different ways. Any potentials that we can use to add and that are these, you know, based on the other way. Are we not adding patience? Yeah. Yeah. We have to be more on the month. So I'm not patient. I need a number of patients. You know, we grow in probably a year. Yeah. [inaudible] Yeah. Yeah. Yeah. It looks like we're adding more month over month. So I'm, uh, And if it, uh, if it didn't, it didn't.
James Gruber: General and Administrative Expenses, which included the $2.0 million T400 filing fee, compared to net income of $4.6 million in the prior year, which included the $5.5 million Royal Commercial Loan.
James Gruber: Comparing the $4.7 million of the prior year period, due primarily to injury sales and marketing expenses related to the BPU go right commercial to Missouri, as well as one time net loss per basic intelligent share ongoing in the quarter was 11 cents. Compared to net income of $2.9 million for the quarter, which includes the $2.0 million ET400 filing fee, compared to net income of $4.6 million in cash on hand and generated $1.3 million of operating cash during the quarter for Missouri.
James Gruber: The total company net worth was $2.9 million for the quarter, which included the $2.0 million Eton Pharmaceuticals Inc.
Sean Brynjelsen: As we wrap up the fall, we need to deliver my revenue and meaning clear by being excited about in the industry to be able to add more cash on our balance. We are rapidly moving, we are just pulling it back in and going on to our future.
James Gruber: Eton finished the second quarter with $17.7 million of cash on hand compared to the prior year and generated $1.3 million of operating and royalty savings.
Sean Brynjelsen: It will be very bright as we've actually given on our current e-dollars, so we'll wrap up the tour near and long-term project. First, we're going for the sales of it. Our stock products are firing at high standards. We saw the record product sales for the quarter. As we wrap up the year-old, we are going to be excited about in the future over the coming quarter. Second, we are rapidly relating to the type of plant standards and I love our futures significantly very right now.
Operator: We remain confident that our basic intelligent share during the quarter was 11 cents compared to net income for the year of $18 million in the prior year period. This concludes our remarks on the second quarter results, and with that, we'll turn it over to the operator for Q&A. Thank you. One moment while we compile the Q&A roster. Your first question comes from the line of Chase Knickerbocker of Craig Hollum. Chase, please go ahead.
James Gruber: I remain confident that our cash-positioned shares are in the quarter to allow us to execute our plan and continue pursuing bolt-on transactions.
Speaker Change: Yeah, friends, he thinks drivers, there may be some additional patients out there that, we sort of, you know, reach them next, maybe they didn't think of before, we're just going to talk to what we're looking for in the communication. For sure, version, let me show you the part of it is brand. These are the products. I'm going to show you all the pride that they're opening in the revenue room, in terms of sure, improvement over the brand product. [inaudible]
James Gruber: pursuing bolt-on transactions in new product development.
Operator: Eton finished the second quarter, and with that, we turned it over to the operator for QMS.
Sean Brynjelsen: We are going to grow on our three-dollars[inaudible] Good afternoon, guys. Thanks for your time. Thank you.
Operator: Thank you. One moment while we compile the Q&A roster, and continue pursuing bolt-on transactions and new product developments.
Chase Knickerbocker: Good afternoon, guys. Thanks for taking the time. Thank you. One moment while we compile the Q&A. Maybe just talk about how the reception's been relative to your expectations when you bought it now that you've relaunched it and interacted with a lot of your physicians. Your first question comes from the line of Chase Knickerbocker of Craig Collins. Chase, please go ahead.
Chase Knickerbocker: Good afternoon, guys. Thanks for taking the time. First, I'll go like...
Speaker Change: A lot of younger patients.
Speaker Change: What we're seeing is that
Chase Knickerbocker: Your first question comes from the line of Chase Knickerbocker of Craig Column. Chase, please go ahead. Good afternoon, guys. Thanks for taking the time. First, maybe on go-like, maybe just talk about how the reception has been, kind of relative to your expectations when you bought it, now that you've relaunched it and interacted with a lot of your physicians. Sure, I appreciate it. We've had very good reception, and we've already seen an uptick in the number of referrals. We haven't promoted for a number of months, so we're still very excited about the product. We still have a lot of hope.
David James: David James, on gross margins, appreciate the commentary on the strength with Al-Kindi in the quarter. Gross margins were a little bit down sequentially. Can you just speak to the drivers there? And then on cash flow positive in the quarter, can you speak to the working capital benefit that you had and then how you kind of see that playing out in the back half of the year? On gross margins, appreciate the commentary on kind of the strength.
Sean Brynjelsen: We've got a very good reception. Good afternoon, guys. Thanks for taking the time.
Sean Brynjelsen: First, maybe I'll go like, maybe just talk about how the reception's been kind of relative to your expectations when you bought it now that you've relaunched it and interacted with a lot of your physicians. We've got a very good reception. We've already seen an uptake in the number of referrals that we get on products before we acquired it. We're still very excited about the product. We still hope to capture 10% of that $100 million market. We started promoting it in mid-April.
Speaker Change: with
Speaker Change: [inaudible]
Sean Brynjelsen: A little bit to get back on a strong growth trajectory. Physicians face the challenge, and they've been very excited to see the support behind the product again. And we've already seen an uptake in the number of referrals that we get on products before we acquired it. We're still very excited about the product. We still hope to capture 10% of that $100 million market. It's just going to take us a little bit to get back on a strong growth trajectory, given that it wasn't there for a number of months before we took over. We've got a couple of new members growing through the year. We're talking about another couple of patients that we've added. Maybe just speak to discontinuation, any potential discontinuation. And then are these basically added another way?
Speaker Change: at least consistent, not I'm slightly improved, you know, margin profile, I guess margin profile, I'm kidding, it makes a real lighter percentage, the overall revenue order.
Speaker Change: I don't think I'm finding more than, from a working capital standpoint, a product mix. You know, absent that and a very different profile than what Altendee, for a moment ago, absent have. We do expect, you know, we turn cash flow positive from an operating standpoint, but it improved in the second half of last year. As we move forward, definitely expect that to continue, even amidst, you know, tighter changes.
Chase Knickerbocker: Thank you for your patience, and you expect to have a...
Chase Knickerbocker: [inaudible]
Speaker Change: from a working catalyst, then point, some sales ring bay, and absent that.
Speaker Change: We should firmly be in positive operating conditions for the rest of 2024, and the second half of next year, definitely expect that to continue.
Sean Brynjelsen: Are we not adding patients, and do you expect to have a decent number of patients growing through the year on CARB-Limited? We think we sort of have reached our max. Patients seem to like our room temperature merger to add additional patients. We just added two more patients recently. It looks like we're going to be adding more month over month. And is that the difference you think is driving it, or are there maybe some additional patients out there that we maybe didn't think of before? Or just kind of talk about what's different versus expectations.
Chase Knickerbocker: And it looks like we're going to be adding more, you know, month after month. So I have, you know, a decent number of patients growing through the year on carbolimic. We think we sort of have reached our max. Patients seem to like our room-temperature version of carbolimic acids better than the...
Chase Knickerbocker: [inaudible]
Speaker Change: even amidst
Speaker Change: You know, timing changes and...
Speaker Change: Got it, thanks. And then maybe just a little bit of color on the ET600 trial. Is it a pretty kind of straightforward, pivotal PKA? Anything you'd call out specifically around the trial that makes it a little bit more complex? Or is it fairly straightforward from a lot of trials that you've ran in the past?
Chase Knickerbocker: And it looks like we're going to be adding more month over month. And is that the difference you think is driving it? Or are there maybe some additional patients out there that we maybe didn't think of before? Or can you kind of talk about what the difference versus expectation is? Yeah, there's certainly part of it.
Speaker Change: Hi, Jason, Sean. So, the trial is a repeat. Yeah, thank you. But maybe a little bit of color on the 80s. I don't know the trial. I mean, different. Is it a pretty kind of straight forward? The pivotal key. Okay. The main thing is how loud is the pitch. Just typically around the trial. They want to work in black. There is a fairly straight forward. We don't expect that. Hi, Jason. Sean. So, this is the trial. The reeval. We don't know. Because it was. Yeah. I don't expect any relevance from. I think the pivotal study may be the gain item. I don't know the design in terms of filing it. But we expect that the file run a file order of 20, 25 of our patients. And it's like we did it. I know the product. That product. The question.
Sean Brynjelsen: Certainly part of it is the ease of the product. I wouldn't be surprised if we're opening up the room temperature improvement over the brand product. But probably more importantly, is that many of the new patients go on our product. So we're getting a lot of younger patients. What we're seeing is that our detailing our services, our patient care. Yeah, that's certainly part of it. The ease of the product. We're no longer shelf life.
Chase Knickerbocker: I would be disappointed if I said these are the products that are no longer on shelf life.
Chase Knickerbocker: I wouldn't be surprised if they're opening in the new room temperature, an improvement over the brand product. And is it that different that you think is driving it, or there may be some additional patients out there that, you know, we maybe didn't think of before, or just kind of talk to about what are the different first specifications? Yeah, I think you're telling our services, our patient care, be part of this program, be ahead of the big impact, find the doctors who are working with the company, and that improvement over the brand product. We're trying to make it easier, more importantly.
Chase Knickerbocker: We're opening in the room temperature improvement over the brand product. But probably more importantly, is that many new patients go on our product. So we're getting a lot of younger patients. What we're seeing is that our describing our services, our patient care, our eating care program has had a big impact. We're showing that the doctors enjoy working with the company. We're trying to make it easy for them so that there aren't a lot of hurdles to providing service.
Chase Knickerbocker: I appreciate the comment on the strength of the company in the quarter. Gross margins were a little bit down sequentially. Can you speak to the drivers there? And then on cash flow positive in the quarter, can you speak to the cash flow positive in the quarter?
Speaker Change: [inaudible]
Chase Knickerbocker: First thing you want to go like, compile the Q&A or talk to how the reception has been, kind of relative to your expectations, when you bought it, now that you've, you know, relaunched it and interacted with the audience.
Chase Knickerbocker: Got it. And maybe, James, on gross margins, I appreciate the commentary on kind of the strength of Alkindi in the quarter. Gross margins were a little bit down sequentially. Can you just speak to some of the drivers there?
Chase Knickerbocker: Your first question comes from the line of Chase Knickerbocker of Craig Hollins. Chase, please go ahead. We've got a very good reception.
Chase Knickerbocker: Good afternoon, guys. Take it the time. First, maybe on go like, maybe to talk to how the reception has been. Kind of relative to your expectations, when you bought it, now that you've, you know, relaunched it, interacted with a lot of people, a lot of your positions. We've got it, maybe on a number of credit group that seems like every kind of quarter, we're talking about, kind of, another couple of patients that we've had.
Speaker Change: would you expect to launch the drug? Got it. And as we got to think about commercial proper therapy with the virus of our city for 100 months, we have you given any thought or additional research. And the pills for as long, and you don't know that there. And that's something that we'll do after potentially. At the moment, we have pretty good coverage on PDF, and you're good in all of our cells, so the rupts we launch, it's our open, really adding up this shortly after or the 8400. So let's say we get a pretty well known. We will already have batteries produced. It is. It is. It's very, it was either kind of in the two of more range. Test button released and ready.
James Gruber: And then on cash flow positive in the quarter, can you speak to kind of the working capital benefit that you had and then how you kind of see that playing out in the back half of the year from a cash flow from operators perspective? We do expect at least a consistent, if not slightly improved, profile. As we move forward, Alkindi makes up a real slight decrease in the second quarter.
James Gruber: We do expect at least a consistent, if not slightly improved, profile as we move forward as Al Kendi makes up a larger percentage.
James Gruber: I don't think it's anything more than a product mix, you know, absent the very different profile that Alkindi filing fee for ET400 has. We do expect at least a consistent, if not slightly improved, profile as we move forward, and Alkindi makes up a larger percentage of overall revenue.
James Gruber: https://www.facebook.com.au
James Gruber: We turned cash flow positive from an operating standpoint in the second half of last year, and I would definitely expect that.
James Gruber: and the second half of last year. And I would definitely expect that to be a larger percentage.
Speaker Change: And at the moment, we have pretty good coverage in October 28th, so the FDA provides the labeling as the last step, and typically, let's say we get approval on February 28th, we will already have batches packaged for product, so I would expect this year, they will be even. Let's just say April, the layers from launching on October 28th is the labeling of the product.
Chase Knickerbocker: Maybe you just speak to kind of different populations, any potential disfiguration. And then, are these, you know, basically at another way? Are we adding patients that you would expect to have a decent number of, so I'm, you know, patient, a decent number of patients growing through the year on carbon. We think we sort of have reached our max on, yeah. And then, you know, we're going to have a decent number of patients growing through the year on carbon.
Chase Knickerbocker: From a working capital standpoint, some sales rebates should be absent that $2 million filing fee for ET400. We should firmly be in positive operating cash flow. You know, we turned cash flow positive from an operating standpoint in the second half of last year. Definitely expect that to continue, you know, even amidst, you know, timing changes. Got it. Thanks. And then maybe just a little bit of color on the ET600 trial. Is it a pretty straightforward, pivotal PK? Anything you'd call out specifically about the trial that makes it a little bit more complex, or is it fairly straightforward from a lot of trials that you've run in the past? Hi Chase, this is Sean.
James Gruber: We should firmly be in positive operating cash flow.
James Gruber: Eton Pharmaceuticals Inc., Chase Knickerbocker, Raghuram Selvaraju, James Gruber, David Krempa
Speaker Change: Normally, the FDA provides the link. Got it. Then it's on BD, Sean. Maybe speak to you. I need three to four. In the carry-off, he has a lot of problems in the way he's dealing with. We're pursuing it. I thought you're thinking about the potential. You know, fairly large. Let's say, right? You can play it on the eight. You know, potentially by the end of the year, you're just kind of subgeneral, more in depth thoughts there, and then just last for James. Got it. Then just on BD, Sean. Speak to kind of the DNA. Please speak back out of the year here. James, you know, in the carry-off of the FDA, is an out-of-as-year. We're pursuing, you know, how you're thinking about at the potential, you know, fairly large. We're pursuing, you know, fairly large. You know, we're, you know, getting into the yard. Just kind of, I don't know, more of that problem. There, and then you'll last for James.
Sean Brynjelsen: So the trial is a repeat of our pilot study, which we passed with Flamco. I don't expect any difference between the pilot study and the pivotal study. The main difference in design is the number of patients. So if you want a pilot and you want a fair number of patients, which we did, we don't expect that to be statistically different from the pivotal study. Because it was spot on in terms of the results.
Sean Brynjelsen: Hi Chase, this is Sean. So the trial is a repeat of our pilot study, which we passed on pharmacology. I don't expect any difference between the pilot study and the pivotal study. The only difference in the design is the number of patients.
Chase Knickerbocker: We think we sort of have reached our max on, yeah. We seem to like a room for time for a minute. We can even add additional matter than the brand added to more. I wouldn't surprise it. And it looks like we're going to be adding more month over month. So I'm, is it, is it, is it that, that difference? You think straddle there? There may be some additional patients out there that, you know, we maybe didn't think of before.
Sean Brynjelsen: I'll do one of the ways a little more complex, or it is one fairly certain, more of him in a lot of trials that we've run. We don't expect that. I'll show you one. It's still just a little bit better.
Sean Brynjelsen: I'd like to give a brief overview of our pilot study because it was spot on in terms of the results from the pilot study to the pivotal study.
Chase Knickerbocker: Kind of talk to what, what's your first expectation? Temperature version, let me show you part of it. Is it the brand? Is it the product? I wouldn't surprise it. They're opening it in the room. Temperature improvement over the brand product. And it's, it's, that's, that difference. You think straddle on there? There may be some additional patients out there that, you know, what we're seeing, maybe didn't think of before. Kind of talk to what are different in terms of expectations.
Speaker Change: both in progress or anything that would deal with $10 million or more in additional revenue would be brought out of the gate.
Sean Brynjelsen: I think the pivotal study of the main difference was the design in terms of filing it.
Speaker Change: So the size of the deal could be in the $20-30 million range. On the VV side, we are pursuing smaller deals where our focus is really on $10 million in a box. At this point, as we've been growing our revenue, we need to do for anything that would give us $10 million or more in additional revenue that are more meaningful. It doesn't really take a lot of work to do a larger deal versus a $20-30 million range. We are expecting to add one to two commercial properties on $10 million. At this point, as we've been growing our revenue, we need to do, believe it or not. So I think that says a lot about where we are in our discussions. It doesn't really take a lot more work to do a larger deal versus a $20-30 million range.
Sean Brynjelsen: and a number of patients. And it's a clinically exciting product. Thank you. Thank you.
Sean Brynjelsen: And it's an exciting product, a product that was requested from doctors and did some market research with spot on patients as well. I think it will be very successful, and it will probably be a great one for us in the upcoming concepts. I think that may be the gating item because in terms of filing it, but we expect that to be filed in the first quarter of 2025. Got it. And as we kind of think about commercial preparation for the potential ET-400 launch, have you given any thought to any additional resources in the sales force, any additional heads there?
Chase Knickerbocker: Our patient care. Part of the program is kind of the big impact. We're longer shelf life. And we'll put the doctors into our board with the company. And that improvement over the brand. And we're going to make it even more of the important way. And so that there are no life hurdle on our product. We're getting a lot of younger patients. What we're seeing is that, yeah. Got it. And maybe James.
Chase Knickerbocker: I'm Greg Margin. I appreciate the commentary on the big impact. Yeah, kind of the strain that the doctors in the, in the quarter. Chris Margin's were a little bit down. So we're currently, you just speak to kind of the drivers there. And then on Capitol positive in the quarter, can you speak to kind of the working capital benefit that you had. And then how you kind of got it at playing out.
Speaker Change: We are expecting to have one to two more products with legal consulting expenses related to ongoing M&A activity. As far as the second half of the year, we expect it to fall back to more like Q1 levels. And that's Chase from an SG&A standpoint. Q2 did have a handful of just one-time items. Namely, some legal consulting expenses related to ongoing M&A activity. As far as the second half of the year, we would expect it to fall back to more like Q1.
Sean Brynjelsen: And as we kind of think about commercial preparations for our ET-400 launch, have you given any thought to any additional resources in the sales force, any additional heads there, and then how soon after a potential approval at the end of February would you expect to launch the drug? We are currently happy with the size of our sales force.
Chase Knickerbocker: Maybe James back half of the year. A lot of growth and growth from operation. I appreciate the commentary on that. Thanks. Yeah, kind of the strength with talking to you in the quarter. Chris Margin, a little bit down. Eventually, you just speak to kind of the drivers there. And then on Capitol positive in the quarter, can you speak to kind of the working capital benefit that you had. And how you kind of see that playing out in the back half of the year.
Sean Brynjelsen: We are very happy with the size of our sales force, and the number of reps we need. We are open to adding additional products for the ET-400 launch, but I don't know that it will be necessary. We will already have batches produced. If it is necessary, it would be kind of in the 2 to 4 range.
Chase Knickerbocker: Absolutely. And kind of that. We do expect, you know, at least consistent or not slightly improved. You know, Margin. I like those margin forward files. How can he make a real larger percentage of overall revenue quarter? I don't think anything more than from a working capital standpoint, a product mix. You know, that's given that the very different. Two million dollar can be filing for you to have 400 have. We do expect, you know, we turn cash.
Speaker Change: Label. But in our heroes significantly change point, that I'm saying, for 2020, I need to look more like two one, the one big driver there is just with, um,
Sean Brynjelsen: They will be tested, released, and ready. The only thing that we have pretty good coverage on February 28th is the labeling of the product. The launch itself really should happen shortly after approval. So let's say we get approval on February 28th.
Speaker Change: Thank you for your participation in this project. There's a decent amount of commercial resource in this initial year. So that's really the one kind of year over year. I am showing no further questions. But it's not going to be for your participation. It's not going to be for your participation. It's not going to be for your participation. It's going to be for the rest of the year.
Sean Brynjelsen: We will already have batches produced, so I would expect the launch to happen.
Sean Brynjelsen: ..
Chase Knickerbocker: I'm not really going to have to improve the second half of the year as we move forward. Definitely expect that. He makes up a larger percentage of over even amidst, you know, type of change. From a working capital standpoint, some sales rebate absent that two million dollar at filing. We should firmly agree in positive operating. And we turn cash or as far as twenty twenty four. In the second half of the quarter gap income.
Speaker Change: Got it. Thanks and congrats on the progress, guys.
Sean Brynjelsen: The FDA provides the labeling for the last step, and you typically need three to four weeks to print a new label and package the product. So I would expect a launch to happen, let's just say April. But to be on the safe side, it could potentially be March. But we'll see. Got it. Just on BD, Sean, maybe speak to the back half of the year here, James, you know, the kind of seasonality of what these deals were pursuing and kind of how you're thinking about it.
Speaker Change: Thank you. Thank you, Chris.
Chase Knickerbocker: Definitely. I think it's a bit of that to continue, you know, even amidst, you know, timing changes. Got it, thanks. And then maybe just a little bit of color on the ET600 trial. Disgusting. Is it a pretty kind of great board, pivotal PK, anything you call out? For the round. Specifically around the trial that makes a little bit more complexer. And it's fairly straightforward from a lot of trials that you've ran the past.
Sean Brynjelsen: On the day-to-day side, we are pursuing deals where price-fit products, identical commercial products, even now, are in progress, or anything that would give us $10 million.
Sean Brynjelsen: Hi, Chase. This is Sean. So the trial is a repeat.
Sean Brynjelsen: Got it, thanks. And then maybe a little bit of color on the ET600 trial. Is it a pretty kind of straightforward, pivotal PK, anything you call out? Specifically around the trial that makes a little bit more complexer. Is it fairly straightforward? No more people on the trial's event. We don't expect that.
Sean Brynjelsen: The size of the deal is going to be in the 20-30 million range, but we are pursuing smaller deals.
Sean Brynjelsen: We're delighted to see the products and the only commercial product that we do when we go, as we've been growing our revenue on the road.
Sean Brynjelsen: Hi, Chase. So I'm still just typically different on the week of the pilot study, because it was, you know, spot dollars or so. I don't expect any results from, I think the pivotal study, maybe the gaming. Any item, for instance, is I, in terms of filing it, but we expect that the file, if you run a file order of 20, 20, 5, a number of patients. And it's pretty good. I didn't know that product.
Sean Brynjelsen: Thank you very much.
Sean Brynjelsen: and Robert Lee at the end of the year, and we're not that far from the end of the year.
Sean Brynjelsen: That product. It's just a request from Dr. Sivital study. It's some market reserve with spot on patients as well. I think it will be very successful. I think for that, maybe the gaming item, because in terms of filing it, but we expect that to be filed in the first quarter.
Sean Brynjelsen: That says a lot about where we are in our meetings.
Sean Brynjelsen: and the rest of the people who are in our discussions. Net Chase from an SG&A standpoint. We are expecting to add one to two commercial products and legal consulting expenses related to ongoing R&A to the end of the year. As far as the second half of the year, that says a lot about perhaps what we are talking about in our discussions.
Operator: [inaudible] Thank you for your participation in today's call. This does conclude the program. You may now
Sean Brynjelsen: Q2 did have a handful of one-time items, the commercial launch, some legal consulting expenses related to ongoing R&A, and a lot of activity. As far as the second half of the year, we would expect it to fall back to more like the Q1 level, but it's not going to significantly change that run rate for 2023. It will look more like Q1. The one big driver there is just the commercial launch.
Operator: I am showing no further questions. Thank you for your participation in today's call. This does conclude the program. You may now disconnect.
Chase Knickerbocker: Got it. Thanks and congrats on the progress, guys.
Operator: Thank you. Thank you, Chase.
Operator: I am showing no further questions.