Q3 2024 Outlook Therapeutics Inc Earnings Call
i
Operator: Carter, Fiscal Year 2024, update, conference call, and webcast. At this time, all participants are in a listen-only mode.
Speaker Change: Greetings and welcome to the Outlook Therapeutics Corporate third quarter fiscal year 2024 update conference call and webcast.
Speaker Change: At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenene Thomas, Investor Relations. Thank you.
Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenene Thomas, Investor Relations. Thank you. Please go ahead. Thank you, Donna.
Jenene Thomas: At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions be leased to expectations for future projections, including but not limited to our expectations about the timing of clinical trials and commercial launch and the sufficiency of our cash resources. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements in this call are made pursuant to the safe harbor provisions of the federal security laws and are based on Outlook Therapeutics' current expectations, and actual results could differ materially.
Speaker Change: Thank you, Donna. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions be leased to expectations for future projections, including but not limited to... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
Speaker Change: Not limited to our expectations about the timing of clinical trials and commercial launch and the sufficiency of our cash resources. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal security laws and are based on Outlook Therapeutics' current expectations, and actual results could differ materially.
Jenene Thomas: As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Outlook Therapeutics files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the SEC's website.
Speaker Change: As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic report.
Jenene Thomas: Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research. While the company believes these third-party sources to be reliable, as of the date of this presentation, they are not independently verified and make no representation as to the adequacy, fairness, accuracy, or completeness of or whether any independent sources have verified any information obtained from third-party sources. During the call management, we'll discuss non-GAAP financial measures, which are not prepared in accordance with generally accepted accounting principles.
Speaker Change: Outlook Therapeutics files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research.
Speaker Change: While the company believes these third-party sources to be reliable, as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of, or had any independent sources verified any information obtained from third-party sources.
Speaker Change: During the call management, we'll discuss non-GAAP financial measures which are not prepared in accordance with generally accepted accounting principles.
Jenene Thomas: Definitions of these non-GAAP financial measures, along with reconciliation to the most direct comparable GAAP financial measures, are included in the Outlook Therapeutics third quarter earnings release, which has been furnished to the SEC and is available on the company's website at ir.outlooktherapeutics.com. Joining us on the call from the Outlook Therapeutics leadership team are Russell Trenary, President and Chief Executive Officer, and Lawrence Kenyon, Chief Financial Officer I'd now like to turn the call over to Russell Trenary.
Speaker Change: Definitions of these non-GAAP financial measures, along with reconciliations to the most direct comparable GAAP financial measures, are included in the Outlook Therapeutics third quarter's earnings release, which has been furnished to the SEC and is available on the company's website at ir.outlooktherapeutics.com.
Speaker Change: Joining us on the call from Outlook Therapeutics' leadership team are Russell Trenary, President and Chief Executive Officer, and Lawrence Kenyon, Chief Financial Officer at Outlook Therapeutics. I'd now like to turn the call over to Russell Trenary. Please proceed. Thank you.
Russell Trenary: Please proceed. Thank you, Jenene, and thank you to everyone joining us for our third quarter fiscal year 2024 conference call and webcast. As we begin today's call, I think it's important for me to start with our mission, and that is, quite simply, to achieve the first ever approval for an ophthalmic formulation of Bevacizumab for the treatment of retinitis, initially in the EU, UK, and US. We're working toward achieving that goal in real time. We've already received marketing authorization in both the European Union and the United Kingdom.
Russell Trenary: Thank you, Janene, and thank you to everyone joining us for our third quarter fiscal year 2024 conference call and webcast.
Russell Trenary: As we begin today's call, I think it's important for me to start with our mission, and that is quite simply to achieve the first-ever approval for an ophthalmic formulation of Bevacizumab for the treatment of retina diseases.
Russell Trenary: initially in the EU, UK, and US.
Russell Trenary: We're working toward achieving that mission in real-time. We've already received marketing authorization in both the European Union and the United Kingdom and are advancing toward the launch of the first approved ophthalmic fevicizumab approved for the treatment of wet AMD in those key markets.
Russell Trenary: And our advancing toward the launch of the first approved ophthalmic phebocizumab approved for the treatment of wet AMD in these key marks. We're also making good progress here in the United States with our ongoing NORSE-8 clinical trial, which, if successful, will serve as the basis for resubmitting our BLA with the FDA, which we expect to occur in the first calendar quarter of 2025. More on that in a
Russell Trenary: We're also making good progress here in the United States with our ongoing NORSE-8 clinical trial, which, if successful, will serve as the basis for resubmitting our BLA with the FDA, which we expect to occur in the first calendar quarter of 2025. More on that in a minute.
Russell Trenary: Focusing on the European Union and the United Kingdom, we're very pleased with the decisions from both regulatory bodies and believe this is the culmination of all the hard work our colleagues and partners have been striving to achieve these past several years. I think it also speaks to and validates the data we have generated, the clinical studies we have conducted, and the CMC work we have completed. We're going to do everything we can to bring this important drug to as many patients as possible in these two territories, which combined represent the second largest market for wet AMD in the world.
Russell Trenary: Focusing on the European Union and the United Kingdom, we're very pleased with the decisions from both regulatory bodies, and believe this is a culmination of all the hard work our colleagues and partners have been striving to achieve these past several years.
Russell Trenary: I think it also speaks to and validates the data we have generated.
Russell Trenary: the clinical studies we have conducted, and the CMC work we have completed. We are going to do everything we can to bring this important drug to as many patients as possible in these two territories, which combined represent the second largest market for wet AMD in the world.
Russell Trenary: Now turning to commercialization, we're continuing with market access work and inventory planning for Germany and the UK and expected product availability in those markets in the first half of calendar 2025. Additionally, we're continuing discussions with organizations that have established EU infrastructure and will continue to evaluate potential partners in the EU.
Russell Trenary: Now turning to commercialization, we're continuing with market access work and inventory planning for Germany and the UK, and expected product availability in those markets in the first half of calendar 2025.
Russell Trenary: Additionally, we're continuing discussions with organizations that have established EU infrastructure and will continue to evaluate potential partners in the EU.
Russell Trenary: Turning to the U.S., we continue to make progress on our NORSATE study, a three-month non-inferiority study with an eight-week efficacy trial. North State is progressing as planned, and we currently have 359, That's three, five, nine, of the planned 400 subjects enrolled. We continue to expect complete enrollment before the end of the third quarter. Top-line results from NORSAT are expected in the fourth quarter of this year and, if positive, should provide sufficient clinical data to resubmit our BLA with the U.S. FDA in the first calendar quarter of 2025.
Russell Trenary: Turning to the U.S., we continue to make
Russell Trenary: A three-month non-inferiority study with an eight-week efficacy endpoint.
Speaker Change: North State is progressing as planned and we currently have 359
Speaker Change: That's 359 of the planned 400 subjects enrolled. We continue to expect a complete enrollment before the end of the third quarter.
Speaker Change: Top-line results from NORSAT are expected in the fourth quarter of this year and, if positive, should provide sufficient clinical data to resubmit our BLA with the US FDA in the first calendar quarter 2025.
Russell Trenary: In addition, we've completed our planned Type C and Type D meetings with the FDA and believe we have addressed the open CMC items that were received in the CRL. Now, it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer.
Larry Kenyon: In addition, we've completed our planned Type C and Type D meetings with the FDA and believe we have addressed the open CMC items that were received in the CRL. And now it's my pleasure to turn the call over to Larry Kenyon, our Chief Financial Officer. Larry? Larry? Larry? Larry? Larry? Larry?
Lawrence Kenyon: Thank you, Raj. Good morning, everyone. During the most recent quarter, we saw a further reduction in the balance of our outstanding convertible note.
Larry Kenyon: Thank you, Roz.
Larry Kenyon: Good morning, everyone.
Lawrence Kenyon: Additional conversions of the notes into common stock have continued in July, and the outstanding balance is approximately $30.3 million as of today. The remaining balance, another $5.5 million, is convertible at $7 per share, with the remaining balance convertible at $40 per share. (Inaudible) Our June 30, 2024 cash position of $32 million, when combined with the expected $107 million of proceeds from a full exercise of warrants. Virtue Shares of Common Stock, Subject Meeting and Requirements for Calling These should be sufficient to support our operations through calendar 2025.
Larry Kenyon: During the most recent quarter, we saw a further reduction in the balance of our outstanding convertible note. Additional conversions of the note into common stock have continued in July, and the outstanding balance is approximately 30.3 million dollars as of today.
Larry Kenyon: Of the remaining balance, another $5.5 million is convertible at $7 per share, with the remaining balance convertible at $40 per share.
Larry Kenyon: Our June 30, 2024 cash position of $32 million, when combined with the expected $107 million of proceeds from the full exercise of warrants.
Larry Kenyon: to purchase shares of common stock, subject to meeting the requirements for calling these warrants, should be sufficient to support our operations through calendar 2025.
Lawrence Kenyon: Moving on to our financial results for the third fiscal quarter of 2024, I can report that we saw a reduction in adjusted net loss from fiscal quarter two of 2020. R&D expenses decreased during the current fiscal quarter versus Q2 of this year after we completed the majority of the North State initiation activities in fiscal Q1.
Larry Kenyon: Moving on to our financial results for the third fiscal quarter of 2024.
Speaker Change: I can report that we saw a reduction in adjusted net loss from Fiscal Quarter 2 of 2024. R&D expenses decreased during the current Fiscal Quarter versus Q2 of this year, after we completed the majority of the North State initiation activities in Fiscal Q1.
Lawrence Kenyon: Previously, we had reported that we estimated a total cost of $30 million to complete NORSE-AID, with most of these expenses to be incurred during the first three calendar quarters of 2024. We have not changed our estimates for NORSE-AID and expect that overall R&D expenses will continue to run at these levels for the next year. Fiscal Q3 G&A expenses increased compared to Fiscal Q2, as we did incur pre-launch expenses for Europe in the most recent year.
Speaker Change: Previously, we had reported that we estimated a total cost of $30 million to complete NORSE 8, with most of these expenses to be incurred during the first three calendar quarters of 2024. We have not changed our estimates for NORSE 8 and expect that overall R&D expenses will continue to run at these levels for the next quarter.
Speaker Change: Fiscal Q3 G&A expenses increased compared to Fiscal Q2 as we did incur pre-launch expenses for Europe in the most recent quarter.
Operator: I will now turn the call back over to the operator for the Q&A. Thank you. The floor is now open to questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue.
Speaker Change: I will now turn the call back over to the operator for the Q&A portion.
Operator: For participants using speaker equipment, it may be necessary to pick up the ham set before pressing the start. Again, that's star 1 to register questions at this time. Today's first question is coming from Julian Harrison of BTIG. Please go ahead. Yes, hi, good morning.
Speaker Change: Thank you so much for watching this video.
Speaker Change: Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star 1 to register questions at this time.
Russell Trenary: Congratulations on all the progress and thanks for taking my questions. First, just on enrollment in North State, are you able to provide any more granular details with regards to how far along you are? I understand completion is still on track for later in the third quarter, calendar quarter of this year, but any more details there you could share at this point? Yeah, I think it's worth noting, Julian, that in this five minutes, we've got dozens of people that are in screening.
Speaker Change: Today's first question is coming from Julian Harrison of BTIG. Please go ahead.
Russell Trenary: And, of course, we track that screening rate to see how many of those convert to actual enrollments, and we believe that right now we've got enough in screening to take us to 380 patients on top of, you know, and, of course, today or yesterday, we were at 359, so we continue to see a good level of screening and expect that to continue so that we can comfortably finish enrollment before the end of the third quarter. Okay, excellent, very helpful.
Julian Harrison: Yes, hi. Good morning. Congrats on all the progress and thanks for taking my questions. First, just on enrollment in North State, are you able to provide any more granular details with regards to how far along you are? I understand completion is still on track for later in the third quarter, calendar quarter of this year, but any more details there you could share at this point?
Speaker Change: Yeah, I think it's worth noting, Julian, that in this five minutes, we've got dozens of people that are in screening.
Speaker Change: and of course we tracked that screening rate to see how many of those convert to actual enrollments and we believe that right now we've got enough in screening to take us to 380 patients.
Speaker Change: on top of, you know, and of course today or yesterday we were at 359 so we continue to see a good level of screening and expect that to continue so that we can comfortably finish enrollment before the end of the third quarter.
Russell Trenary: And then when enrollment completion is confirmed in NORSE 8, does it become easier to guide to specifically when you expect BLA resubmission? I understand your updated guidance for 1Q25, but does it become easier to be more precise in that guidance once enrollment completion is confirmed? Yes, yeah, because I think the amount of time between the last patient treated and when their last visit is scheduled is known. And the amount of time to lock and clean the databases is predictable.
Speaker Change: Okay, excellent, very helpful. And then, when enrolling.
Speaker Change: Completion is confirmed in NORSE 8. Does it become easier to guide to specifically when you expect BLA resubmission? I understand your updated guidance for 1Q25, but does it become easier to be more precise in that guidance once enrollment completion is confirmed?
Speaker Change: Yes, yeah, because I think there's a the amount of time between the last patient treated
Speaker Change: and when their last visit is scheduled is known. And the amount of time to lock and clean the databases is predictable. So, yeah, we will be in a better position to nail that down once we know when enrollment completion has occurred.
Russell Trenary: So yeah, we will be in a good position, a better position to nail that down once we know when enrollment completion has occurred. Great, thank you. Thanks, Julian.
Operator: Thank you. The next question is coming from Will Hiddell of Brooklyn Capital Markets. Please go ahead. Hey, thank you for taking the questions. Quick question about the UK process with NICE.
Speaker Change: Great, thank you.
Julie: Thanks, Julian.
Speaker Change: Thank you. The next question is coming from Will Hedell of Brookline Capital Markets. Please go ahead.
Will Hadell: Hey, thank you for taking the questions. Quick question about the UK process with NICE. I know, I think they're going to have a tech assessment delivered by maybe December . Is there any updates on that process?
Speaker Change: I think really the only update we have is that we believe we put together a...
Speaker Change: of well-informed dossier tonight and we're going through the process with them. They've accepted our our application and so we're going through that process and and.
Speaker Change: will know you know later in the year just exactly what that what what that looks like in terms of the type of pricing that we'll be that we'll be utilizing in that market.
Speaker Change: Okay, thank you.
Operator: Thank you. The next question is coming from Tim Chiang of Capital One. Please go ahead.
Speaker Change: Thank you. The next question is coming from Tim Chang of Capital One. Please go ahead.
Russell Trenary: Hi Russell, could you just talk a little bit about, you know, what came out of the type C and D meetings that you had with the FDA? I noticed the timing of the filings extended to 1Q of next year. So I just wondered if there was any correlation between your discussions with the FDA and the push out in the filing? None.
Tim Chang: Hi, thanks. Russell, could you just talk a little bit about, you know, what came out of the type C and D meetings that you had with the FDA? I noticed the timing of the filings.
Russell Trenary: extended to 1Q of next year. So I just, is there any correlation between your discussions with the FDA and the push out in the filing?
Russell Trenary: Really, the timing of the filing is really associated with our prediction of completion of enrollment. It's solely focused on that. After we had the first type A meeting with FDA, they encouraged us, aside from having discussions around what the additional clinical trial design would look like, they also encouraged us during that meeting to come back and meet with... end, during the course of the trial to talk to their CMC group about the questions that they had.
Speaker Change: none, really the
Speaker Change: The timing of the filing is really associated with our prediction on completion of enrollment. It's solely focused on that.
Speaker Change: the After we had the first type a meeting with with FDA. They encouraged us, you know aside from aside from
Speaker Change: having discussions around what the additional clinical trial design would look like. They also encouraged us during that meeting to come back and meet with them.
Speaker Change: during the course of the trial to talk to their CMC group.
Speaker Change: around the questions that they had in there. So we took them up on that offer.
Speaker Change: And so I think we would characterize our discussions with FDA as having been very positive. And I think we've now reviewed with FDA every single question that they had.
Speaker Change: on the CMC's list, and so we're happy to say we've completed those meetings.
Speaker Change: and we'll continue to finish up some of the work, but we're really at a point where we're just going to publishing on answers to those CMC questions. So we're quite satisfied with how that turned out.
Speaker Change: Okay, great. That's helpful. Thanks, Russell.
Operator: Thanks, Russell. Thank you. The next question is coming from Douglas Tsao of H.C. Wainwright. Please go ahead. Hi, good morning.
Speaker Change: You bet.
Speaker Change: Thank you. The next question is coming from Douglas Tsao of HC Wainwright. Please go ahead.
Russell Trenary: Thanks for taking the questions. Just curious, so in terms of the timing of the DLA filing, as has been noted, you sort of got into the first quarter versus the fourth quarter. Just curious exactly what led to that, and my guess is maybe patient enrollment is a little behind where you expected, and was that the result of just the pace of patients coming in, or just did you not quite get as many sites up and running as quickly as you maybe anticipated? Thank you. Yeah, thanks, Doug.
Douglas Tsao: Hi, good morning. Thanks for taking the questions.
Douglas Tsao: Just curious, so in terms of the timing of the BLA filing, as has been noted, you're sort of now got into the first quarter versus the fourth quarter. I'm just curious exactly what led to that and my guess is maybe patient enrollment's a little behind where you expected and was that the result of just
Douglas Tsao: the pace of patients coming in or just did you not quite get as many sites up and running as quickly as you may be anticipated? Thank you.
Russell Trenary: Yeah, I think for us to be able to hit that end-of-year enrollment timing, or, you know, to be able to resubmit the BLA by the end of the year, we would have had to finish enrollment by the end of July. Our current enrollment pace is about two times faster than the industry average. Most people talk about in the industry that it takes, you know, a patient per doctor per site to – that's what should be predicted. And so, if that were the case, then it would have taken us all the way to the end of the year to enroll.
Speaker Change: Yeah, thanks Doug. Yeah, I think for us to be able to hit that that end of year
Speaker Change: enrollment timing or, you know, to be able to resubmit the BLA by the end of the year. We would have had to finish enrollment by the end of July.
Speaker Change: Our current enrollment pace is about two times faster.
Speaker Change: than the industry average. Most people talk about.
Speaker Change: in the industry that it takes a patient per doctor.
Speaker Change: for site to that that's that's what should be predicted and so if that were the case then it would have taken us all the way to the end of the year.
Speaker Change: to enroll. Instead, we're going to finish enrollment.
Russell Trenary: Instead, we're going to finish enrollment by the end of the third quarter. So, I think it was just a really aggressive goal that we're almost going to hit, but it's going to – but I think it does – because we did not hit the end of July, it puts us into the beginning of next year in terms of BLA submissions. Okay, great. And in terms of the European launch, I'm just curious what kind of investments you are making in terms of inventory and then for the European launch.
Speaker Change: by the end of the third quarter.
Speaker Change: I think it was just a really aggressive goal that we're almost going to hit, but I think it does, because we did not hit end of July , it puts us into the beginning of next year in terms of BLA submission.
Speaker Change: Okay, great. And in terms of the European launch, I'm just curious, what kind of investments are you making in terms of inventory and then for the European launch? And is that going to potentially, you know, provide supply for the U.S. launch as well? Thank you.
Speaker Change: Yeah, it could. We actually went into, we had some inventory ready for August 29th of last year when we expected approval from FDA.
Speaker Change: So that inventory is still sitting there.
Speaker Change: and it's going to be available for sale in the European area and or in the United States.
Russell Trenary: And, you know, I think one of the nice things about having built that inventory is we're continuing to be able to extend the shelf life of that product. So I think by the end of the year, we're expecting to have between 30 and 36 months of dating on that product. So I think that's kind of the work that's being done on inventory right now is really just tracking stability and extending shelf life. Thank you. Our next question is coming from Daniil Gataulin of Shardin. Please go ahead.
Speaker Change: and you know I think one of the nice things about having built that inventory is we're continuing to be able to extend the shelf life of that product.
Speaker Change: So I think by the end of the year, we're expecting to have between 30 and 36 months of dating on that product. So I think that's kind of the work that's being done on inventory right now, is really just tracking stability and extending shelf life.
Speaker Change: Thank you.
Speaker Change: Thank you for watching this video, and don't forget to like, share, and subscribe to our channel.
Speaker Change: [inaudible]
Speaker Change: Thank you.
Speaker Change: Our next question is coming from Daniel Godolin of Chardon. Please go ahead.
Daniel Godolin: Hi, good morning guys. Thanks for taking the question and congrats on all the progress.
Daniel Godolin: I have a quick one. So with the kind of approval in the EU and UK, how does the off-label use dynamics change there between now and launch and, you know, shortly after launch?
Speaker Change: And as a follow-up, what are the prior notice options or checklist items on your list for the commercial launch in Europe in the first half? Thank you.
Operator: Thank you. Yes, so in terms of off-label use, the situation in Europe is really different market by market. There are some markets where off-label use is close to zero because it's not allowed, and in those markets, people are following the law, and they're not repackaging or compounding in other markets.
Speaker Change: Yes, so in terms of off-label use, the situation in Europe is really different market by market.
Russell Trenary: It's also unlawful, but it's tolerable for now, and I think the thing that we hear from doctors and from payers is that they like having a source of Bevacizumab available; it's the only molecule of its kind, and so they'll turn a blind eye for a little bit of time, at least on offering off-label products. So I think once we're approved, you know, I think the market research and the customer conversations that we've had indicate that doctors and payers will get it.
Speaker Change: There are some markets where off-label use is close to zero because it's
Speaker Change: It's not allowed, and in those markets people are following the law, and they're not repackaging or compounding. In other markets, it's also unlawful, but it's tolerated.
Speaker Change: for now and and I think the the thing that we hear from from doctors is and and from payers is that they like having a source of Bevacizumab available. It's the only molecule of its kind and so they'll turn a blind eye for a little bit of time.
Speaker Change: at least on offering off-label products. So I think once we're approved.
Speaker Change: You know, I think the market research and the customer conversations that we've had indicate that doctors and payers, they get it.
Russell Trenary: They understand that the standards that we have to live by, and the standards that we have lived by with the product that was used in our clinical trial are different for that bevacism lab that we have versus the bevacism lab that was originally developed and designed to treat oncology and be delivered through a drip IV. So, those standards for oncology don't meet ophthalmic standards for things like utter lack of particularity. They don't meet the requirements, they're not, they don't have the same requirements for pH levels.
Speaker Change: They understand that the standards that we have to live to and the standards that we have lived to with the product that was used in our clinical trial.
Speaker Change: are different for that bevacizumab that we have versus the bevacizumab that was originally developed and designed to treat oncology and be delivered through a drip IV.
Speaker Change: Thank you. Bye. Bye. Bye.
Speaker Change: Those standards for oncology don't meet ophthalmic standards for things like utter lack of particulates.
Russell Trenary: They don't have the same requirements for endotox levels. They don't have the same requirements for approved packaging for use in ophthalmology, and validation that the vile or syringe, that the oncologic version comes from meat according to ophthalmic standards. So there are a whole host of things that off-label Bevacizumab doesn't provide the payer and the customer compared to an ophthalmic-approved version of Bevacizumab.
Speaker Change: They don't meet this. They're not they don't have the same requirements for pH levels. They don't have the same requirements for endotox levels
Speaker Change: They don't have the same requirements for approved packaging for use in ophthalmology.
Speaker Change: and validation that the vial or syringe that the oncologic version comes from meet ophthalmic standards.
Speaker Change: So there are a whole host of things that off-label Bevacizumab don't provide the payer and the customer compared to an ophthalmic approved version.
Russell Trenary: So, we think that we'll be in a great position to go in. In those markets where it takes a while for the off-label to go away, we think we can compete with them based on quality, based on clinical data and ophthalmology, based on meeting all the GMP standards, and based upon having the right amount of drug protein concentration, vial by vial, syringe by syringe that is never validated, from a product that comes out of the re
Speaker Change: of Bevacizumab. So we think that we'll be in a in a great position to go in.
Speaker Change: in those markets where it takes a while for the off-label to go away.
Speaker Change: We think we can compete with them based on quality, based on clinical data and ophthalmology.
Speaker Change: based on meeting all the GMP standards.
Speaker Change: And based upon having the right amount of drug protein concentration vial by vial, syringe by syringe, that is never validated.
Speaker Change: from a product that comes out of the repackaging effort.
Russell Trenary: I think, you know, the right product profile, the right level of quality, and the right price point will put us in a position where we'll be a very able competitor against off-label bevacizumab, but it's a little different market by market. Thank you. And in terms of the assumptions and the checklists for launch in the first half of 2025?
Speaker Change: So, I think, you know, the right product profile, the right level of quality, and the right price point will put us in a position where we'll be a very able competitor against off-label bevacizumab. But it's a little different market by market.
Speaker Change: Thank you. And in terms of the assumptions and the checklists for launch in this first half of 2025?
Russell Trenary: Yeah, it's really the... whether we're hiring our own. So basically, the work that we're engaged in right now is market action. So we're in hot pursuit of the health technology assessment groups. And we're talking to NICE, we're talking to that same counterpart in Germany to establish with the payer community what it is that they're looking for in terms of pricing and availability. So the HTA work comes first.
Speaker Change: Yeah, it's really the whether we're hiring our own, so basically the work that we're engaged in right now is market access.
Speaker Change: So we're we're in in hot pursuit of the health technology assessment groups
Speaker Change: and we're talking to NICE, we're talking to that same counterpart in Germany to establish
Speaker Change: with the payer community what it is that they are looking for in terms of
Russell Trenary: That market access work has to be done. In addition to that, we're going through the process of showing up at trade shows, conducting symposia with doctors, and really doing some of the good communication that's required with the retina community to help them understand what the real difference is between an ophthalmic Bevacizumab approved Bevacizumab versus what they've had available to them today. We love having those conversations, but doctors do have a preference for a regulatory-approved ophthalmic version. All the market research points to that.
Speaker Change: of Pricing and Availability.
Speaker Change: The HTA work comes first. That market access work has to be done. In addition to that, we're going through the process of.
Speaker Change: I'm showing up at trade shows, conducting symposia with doctors, and really...
Speaker Change: doing some of the good communication that's required.
Speaker Change: with the retina community to help them understand what the real difference is between an ophthalmic approved Bevacizumab versus what they've had available to them today. We love having those conversations.
Speaker Change: The doctors do have a preference for a regulatory-approved ophthalmic version. All the market research points to that, so we're continuing to engage in all of that work.
Russell Trenary: So we're continuing to engage in all of that. And then the final step, whether it's with a partner or whether it's our own, would be to make the decision to put a sales force and a group of medical scientific liaisons, so-called MSLs, on the ground so that the appropriate conversations can take place with the customers. Kenneth, thank you very much. Thank you. At this time, I would like to turn the floor back over to Mr. Trenary for closing comments. Great, thank you so much.
Speaker Change: And then the final...
Speaker Change: The final step will be, whether it's with a partner or whether it's our own, would be to make the decision to put a sales force and a group of medical scientific liaisons, so-called MSLs, on the ground so that the appropriate conversations can take place with the customers.
Speaker Change: Kenneth, thank you very much.
Speaker Change: Thank you. At this time, I would like to turn the floor back over to Mr. Trenary for closing comments.
Russell Trenary: Well, look, we believe this is a really exciting time for Outlook Therapeutics, and the next few months have the potential to continue to transform the profile of our company. So to summarize what we've talked about today, in Europe, the second largest market for wet AMD, we received marketing authorization in the EU and the United Kingdom. We're actively advancing market access initiatives, preparing product inventory, and are in discussions with potential partners to launch in these key marks.
Mr. Canary: Great, thank you so much. Well, look, we believe this is a really exciting time for Outlook Therapeutics.
Mr. Canary: and the next few months have the potential to continue to transform the profile of our company.
Speaker Change: So, to summarize what we've talked about today, in Europe, the second largest market for wet AMD, we received marketing authorization in the EU and the United Kingdom.
Speaker Change: And we're actively advancing market access initiatives, preparing product inventory, and are in discussions with potential partners to launch in these key markets.
Russell Trenary: In the U.S., we remain on track with enrollment for NORS AID and expect to report top-line results this calendar year and resubmit our BLA early in the first calendar quarter of 2025. We look forward to continuing this progress and the opportunity to bring an enhanced level of care to the retina. Thanks so much for joining us. Ladies and gentlemen, this concludes today's event. You made this connector aligns at this time, or log off the webcast and enjoy the rest of your day. [inaudible]
Speaker Change: In the U.S., we remain on track with enrollment for NORSE-AID and expect to report top-line results this calendar year and resubmit our BLA early in first calendar quarter 2025.
Speaker Change: We look forward to continuing this progress and the opportunity to bring an enhanced level of care to the retina anti-VEGF space.
Speaker Change: Thanks so much for joining us today.
Speaker Change: Ladies and gentlemen, this concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.
Operator: Hi, good morning guys. Thanks for taking the question and for the congress amount of progress. I have a quick one, a series full of kind of approval in the EU and the UK. How does the off-label use dynamics change there between now and launch and, you know, shortly after launch? And as a follow-up, what are the parts of the solutions or checklist items on your list for the commercial launch in Europe in the first half?
Russell Trenary: And is that going to potentially provide supplies for the U.S. launch as well? Thank you. Yeah, it could. We actually went into production, and we had some inventory ready for August 20th of last year when we expected approval from FDA. So that inventory is still sitting there, and it's going to be available for sale in the European area and or in the United States. Yeah, it's going to be available for sale.
Russell Trenary: I know I think they're going to have a tech assessment delivered by maybe December. Are there any updates on that process? I think the really only update we have is that we believe we put together a well-informed dossier tonight and we're going through the process with them.
Russell Trenary: They've accepted our application, and so we're going through that process. We'll know later in the year just exactly what that looks like in terms of the type of pricing that will be utilized in that market. Okay, thank you.
Russell Trenary: So we took them up on that offer, and so I think our discussions with FDA have been very positive, and I think we've now reviewed with FDA every single question that they had on the CMC list, and so we're happy to say we've completed those meetings, and we'll continue to finish up some of the work, but we're really at a point where we're just going to publish answers to those CMC questions, so we're Okay, great. That's helpful.