CorMedix Inc. Q1 2023 Earnings Call

Operator: Should you need assistance, signal the conference specialist by pressing the Starkey followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would like to turn the conference over to Monique Cossey.

Speaker 1: That.

Monique Cossey: Please go ahead. Thank you. Good afternoon, everyone, and welcome to the Corps Medics first quarter, 2023 earnings conference call. Leading the call today is Joe Tedisco, Chief Executive Officer of Corps Medics. And he is joined by Dr. Matt David, Executive Vice President and CFO; Dr. Phoebe Mounce, EVP and General Counsel; and Aaron Mystery, EVP and Chief Commercial Officer. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, the following.

Speaker 1: qu questionions.

Speaker 1: The.

Monique Cossey: Any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program, manufacturing activities, and NDA approval for Dief and CAF in the U.S. or other product candidates, future financial position, future revenues, and projected costs, and potential market acceptance of DiefenCath or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans, the timing, cost, progress, results, estimates, and interpretations thereof, projections as to the company's future capital raising and spending and cash positions, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development, or other transactions, any commercial plans and expectations, market projections for product candidates, and expectations as to manufacturing and product component costs.

Speaker 1: Mar.

Speaker 2: first quarter 2023 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by hero.

Speaker 2: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. So, withdraw your question, please press star then two. Please note, this event is being recorded.

Speaker 2: I would now like to turn the conference over to my Nick Cossie. Please go ahead.

Speaker 3: Thank you. Good afternoon everyone and welcome to the Core Medics first quarter 2023 earnings conference call.

Monique Cossey: Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization. These risks are described in greater detail in Corps Medics' filing with the SEC, including the latest quarterly report on Form 10Q and annual report on Form 10K, copies of which are available free of charge at the SEC's website at www.org.org or upon request from CoreMetics. CoreMetics may not actually achieve these goals or plans described in these forward-looking statements. And investors should not place undue reliance on these forward-looking statements.

Speaker 3: Leading the call today is Joe Tudisco, Chief Executive Officer of Cormatics, and he is joined by Dr. Matt David, Executive Vice President and CFO , Dr. Phoebe Mounts, EVP and General Counsel, and Aaron Mystery, EVP and Chief Commercial Officer.

Speaker 3: Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the Meaning Set-forth in the Private Security's Litigation Reform Act of 1995.

Speaker 3: These statements are subject to certain risks and uncertainties and include but are not limited to any of the following.

Speaker 3: Any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about companies' prospects.

Monique Cossey: Please note that Comedics does not intend to update these forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of CoreMedics. Joe, please go ahead. Thank you, Monique. Good afternoon, everyone.

Speaker 3: including its clinical development program, manufacturing activities, and NDA approval for deep and cap in the US or other product candidates.

Speaker 3: future financial position, future revenues and projected costs, and potential market acceptance of DeFencap or other product candidates.

Joseph Todisco: And thank you for joining us on this call. Since our last earnings call in March, the company has achieved a number of key milestones. Most importantly, today's announcement that the NDA for DefendCath is being resubmitted to the FDA. I'm incredibly proud of the team that has worked so hard to ensure the company would achieve this important objective.

Speaker 3: More specifically, Ford looking statements include any statements about our clinical development plans. The timing, cost, progress, results, estimates, and interpretations thereof.

Speaker 3: projections as to the company's future capital raising and spending and cash position, expectations to the timing and nature of anticipated regulatory actions.

Joseph Todisco: CV will provide more color around the substance of our type A meeting with FDA in April. And, as we announced a few weeks ago, we do expect the resubmission to be classified as a class two with a six-month review and anticipate a target action date in November. We will update investors once we have confirmation from FDA regarding the submission status of the NDA. In addition to our resubmission, we also announced two key business updates that can be important value drivers for DefendC.

Speaker 3: possible product licensing, business development, or other transactions, any commercial plans and expectations, market projections for our product candidates, and expectations as to manufacturing and product component costs.

Speaker 3: Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization.

Speaker 3: These risks are described in greater detail in core metaxis filing with the SEC, including the latest quarterly report on Form 10Q, and annual report on Form 10K. Copies of which are available free of charge at the SEC's website at www.

Joseph Todisco: The first was following our submission of a duplicate new technology add-on payment or N-TAP application in the fourth quarter of 2022 to the Centers for Medicare and Medicaid Services. TMS has now issued the inpatient prospective payment system 2024 proposed rule that includes an N-TAP of up to $17,111 per hospital stay for DefendC. This is a meaningful increase above the previously approved NTAP and represents reimbursement to inpatient facilities at 75% of the anticipated WAC price of 1,170 per 3-millimeter vial vial, with an average utilization of 19.5 vials per hospital.

Speaker 3: or upon request from Core Medics.

Speaker 3: Core Medics may not actually achieve these goals or plans described in these forward-looking statements and investors should not place undue reliance on these statements.

Speaker 3: Please note that Cometics does not intend to update these forward looking statements except as required by law.

Speaker 3: At this time, it is now my pleasure to turn the call over to Joe to Disco Chief Executive Officer of Cormatics.

Speaker 2: Joe, please go ahead. Thank you, Monique. Good afternoon, everyone, and thank you for joining us on this call.

Joseph Todisco: As we mentioned in our recent update, Cormetics will be migrating to FennCath from a 5-millimeter vial volume based upon market preference, and this NTAP application was submitted with that migration in mind. The final IPPS rule will be published in late summer, and we expect this payment amount to be issued in that final rule.

Speaker 2: Since our last earnings call in March, the company has achieved a number of key milestones. Most importantly, today's announcement that the NDA for DefendCat is being resubmitted to the FDA. I am incredibly proud of the team that has worked so hard to ensure the company would achieve this important objective.

Speaker 2: CV will provide more color around the substance of our Type A meeting with FDA in April . As we announced a few weeks ago, we do expect the resubmission to be classified as a Class 2 with a 6-month review and anticipate a target action date in November .

Joseph Todisco: This ENTAP is conditioned upon the DefendCAT NDA obtaining final FDA approval prior to July 1st, 2024. The company also recently announced that the U.S. Patent and Trademark Office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly allowed U.S. patent application reflects the unique and proprietary nature of DefendC and will extend our current intellectual property protection to an anticipated expiration date in 2042, which is beyond the 10 and a half years of marketing exclusivity available upon FDA approval of the DefendCath NDA.

Speaker 2: We will update investors once we have confirmation from FDA regarding the submission status of the NDA.

Speaker 2: In addition to our resubmission, we also announce two key business updates that can be important value drivers for DefendTab.

Speaker 2: The first, with it following our submission of a duplicate new technology add-on payment or NTAF application in the fourth quarter of 2022 to the Centers for Medicare and Medicaid Services.

Speaker 2: CMS has now issued the Inpatient Perspective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for Defendcat.

Speaker 2: This is a meaningful increase above the previously approved end-tap and represents reimbursement to inpatient facilities at 75% of the anticipated whack price of 1,170 per 3-millimeter vial with an average utilization of 19.5 v for hospital as we mentioned in our recent update.

Joseph Todisco: Once this patent is granted, we plan to seek listing in FDA's publication, approved drug products with therapeutic equivalence evaluation, known as the Orange Book, which identifies approved drug products and includes related patent and exclusivity, as part of the NBA approval process. While our technical and regulatory teams have been working diligently toward our resubmission and preparing the supply chain for potential commercialization, Our commercial and medical affairs teams have been engaging with key stakeholders across settings of care to ensure Corps Medics is in position to maximize the value of defense, As the initial phase of our launch will focus on inpatient utilization, we have begun engaging with leadership members of pharmacy and technology committees at multiple health systems, hospitals, and integrated delivery networks to better prepare for the formulary process.

Speaker 2: Chorometics will be migrating to FENCATs from a 5ml to a 3ml vial volume based on market preferences. This NTAP application was submitted with that migration in mind.

Speaker 2: The final IPPS rule will be published in late summer and we expect this payment amount to be issued in that final rule.

Speaker 2: This intat is conditioned upon the DefendCath MBA obtaining final FDA approval prior to July 1st of 2024.

Speaker 2: The company also recently announced that the US patent and trademark office has issued in most of the allowance of patent claim.

Speaker 2: directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central vein as catheters.

Speaker 2: This newly allowed US patent application reflects the unique and proprietary nature of defend cap.

Speaker 2: and will extend our current intellectual property protection to anticipated expiration date in 2042, which is beyond the 10 and a half years of marketing and specific available upon an FDA approval of the DefendCat NDA.

Joseph Todisco: We expect to work with health institutions during the upcoming months to establish baseline infection rates at their respective institutions, such that the impact of FENCAP utilization in the system can be quantified. On the outpatient side, we've also intensified engagements with potential customers and stakeholders as we prepare for discussions with CMS related to outpatient reimbursements. Catheter-related bloodstream infections remain one of the most severe complications associated with receiving hemodialysis through a central venous catheter.

Speaker 2: Once this patent is granted, we plan to seek listing and FDA's publication approved drug products with therapeutic equivalence evaluation.

Speaker 2: known as the orange book, which identifies approved drug products and includes related patent and exclusive information.

Speaker 2: as part of the MBA approval process.

Speaker 2: While our technical and regulatory teams have been working diligently toward our resubmission and preparing the supply chain for potential commercialization,

Speaker 2: Our commercial and medical affairs teams have been engaging with key stakeholders across settings of care to ensure core medics is in position to maximize the value of defenca.

Phoebe Mounts: An adequate reimbursement to dialysis providers for infection prevention is essential to improving patient alcohol. However, a formal application for outpatient reimbursement cannot be submitted until after an NDA receives FDA approval. However, we do expect to begin a dialogue with CMS, providing the agency with documentation supporting our reimbursement position over the upcoming month. I will now turn the call over to Phoebe to discuss our type A meeting with FDA and potential timelines for FDA approval. Phoebe?

Speaker 2: As the initial phase of our launch will focus on impatient utilization, we have begun engaging with leadership members of pharmacy and technology committees at multiple health systems, hospitals, and integrated delivery networks to better prepare for the formulary process.

Speaker 2: We expect to work with health institutions during the upcoming months to establish baseline infection rates at their respective institutions, such that the impact of the FENCAST utilization in the system can be quantified.

Speaker 2: On the outpatient side, we've also intensified engagement to essential customers and stakeholders as we prepare for discussions with CMS related to outpatient reimbursement. Cathar related blood sugar infections remain one of the most severe complications associated with receiving hemodialysis through essential vein as catheter.

Phoebe Mounts: Thanks, Joe. Good afternoon, everyone. First, I would like to start by expressing my gratitude to the technical and regulatory teams that have worked diligently to prepare to resubmit the DefendCath NDA as soon as possible. As you know, Cormetics received a complete response letter in August of 2022 due solely to deficiencies cited by contract manufacturers of active pharmaceutical ingredients and finished product, but not citing any Defendcast or clinical related deficiencies. Since August, our technical and regulatory teams have been developing three different pathways, utilizing alternative CMO and API suppliers to ensure NDA resubmission as quickly as possible, which we discussed during the last two earnings calls.

Speaker 2: An adequate reimbursement to the alpha providers for infection prevention is essential to improving patient outcome. A formal application for outpatient reimbursement cannot be submitted until after an MDA receives FDA approval. However, we do expect to begin a dialogue with CMS.

Speaker 2: dividing the agency with documentation supporting our reimbursement position over the upcoming months.

Speaker 2: I will now turn the call over to Phoebe to discuss our type B meeting with FDA and potential timelines for FDA approval. Phoebe? Thanks, Joe. Good afternoon, everyone. First, I would like to start by expressing my gratitude to the technical and regulatory teams that have worked diligently.

Speaker 3: prepared to resubmit the DefendCath NDA as soon as possible. As you know, Chormatics received a complete response letter in August of 2022. Do solely to deficiency cited at contract manufacturers of active pharmaceutical ingredients.

Phoebe Mounts: In March, we submitted a Type A meeting request to FDA, discussed plans for the NDA resubmission, and we were gratified that FDA granted the request for a meeting in April. We provided FDA with significant documentation and compelling justification for Pathway 1 that would utilize our existing CMO and existing API supplier to support a Class 1 resubmission with a 60-day review period. The discussion with FDA related to Pathway 1 was very positive and productive.

Speaker 4: and finished product, but citing no defend calf or clinical related deficiencies.

Speaker 4: Since August , our technical and regulatory teams have been developing three different pathways, utilizing alternative CMO and API suppliers to ensure NVA resubmission is quickly as possible, which we have discussed during the last two earnings calls. In March, we submitted a type A meeting request to FDA.

Speaker 4: Discuss plans for NDA resubmissions and we were gratified that FDA granted the request for a meeting in a gromp. We provided FDA with significant documentation and compelling justification for pathway 1 that would utilize our existing CMO.

Phoebe Mounts: However, based upon FDA's feedback, it was apparent that CoreMedics would be better served by resubmitting the NDA, not only with our existing CMO, but incorporating multiple sources of Pepper and API. The inclusion of multiple sources of Heparin API necessitated the inclusion of new manufacturing information in the submission, which we expect to result in a class two resubmission with a six-month review period.

Matthew T. David: We view the discussion with FGA as highly valuable, and following our receipt of the formal meeting minutes from this discussion, CorpsMedics is now resubmitting the DefendCath NDA in accordance with agency guidance. We believe that when the NDA is accepted for filing, it will be deemed a Class 2 resubmission with a six-month review and receive a FDUFA target action date in November. As Joe mentioned, Chormetics will provide additional updates if and when these milestones are achieved. I would now like to turn the call over to Matt, who will provide a financial update. Matt?

Matthew T. David: Thanks, Phoebe, and good afternoon, everyone. I am pleased to be here today to provide an overview of our first quarter 2023 financial results, as well as an update on CoreMedics' cash. The company has filed its quarterly report on Form 10Q for the quarter-ended March 31st, 2020. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our first quarter of 2023 financial results, a net loss was approximately 10.6 million or 24 cents per share compared with a loss of 7.0 million or 18 cents per share in the first quarter of 2022.

Matthew T. David: The higher net loss recognized in 2023 compared with 2022 included an increase in R&D expenses and SG&A expenses versus the first quarter of 2022. Operating expenses in the first quarter of 2023 increased approximately 57% to 11 million compared with 7 million in the first quarter of 2022. R&D expense increased by approximately 49% to $3.4 million, driven primarily by an increase in personnel expenses and non-cash charges for stock-based compensation, and increases in costs related to medical affairs activities and costs related to the manufacturing of the FENCAP prior to its potential market.

Matthew T. David: These increases were partially offset by a decrease in consulting fees for the period. SGNA expense increased approximately 60% to $7.6 million in the first quarter of 2023 compared with $4.8 million in the first quarter of 2022. This increase was primarily attributable to an increase in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefendCath, an increase in personnel expenses due to additional hires, and an increase in non-cash charges for stock and cost-based compensation. These increases were partially offset by decreases in legal fees for the period.

Joseph Todisco: We recorded net cash used in operations during the first quarter of 2023 of 10.4 million compared with net cash used in operations, 6.7 million for the first quarter of 2022. Cormetics remains in a good position from a balance sheet. The company has cash and cash equivalents of $55.6 million as of March 31, 2021, 2023. This includes approximately 7.2 million raised during the first quarter of 2023 through our ATM program, including approximately $3.7 million in net proceeds from our ATM program following the end of the first quarter of 2023.

Joseph Todisco: Cormetics has pro forma cash and equivalence of approximately $59.3 million as of March 31st, 2023. We believe our cash and cash equivalence gives the company flexibility to fund its operations at least through the first half of 2024. After taking into consideration costs related to manufacturing activities and costs related to commercial launch preparation in anticipation of the potential FDA approval of defense. I will now turn the call back over to Joe for closing remarks. Joe

Joseph Todisco: Thanks, Matt. As I mentioned earlier, I believe the company is executing well on our key objectives, and we're now increasing our focus on commercial readiness. Over the last few months, we've made a number of key leadership hires in both commercial operations and medical affairs. Most notably, new heads of market access, government affairs, strategic partnerships, and trade. We will continue to add additional resources as we progress through milestone events during the year. As we said earlier, we anticipate a target action date in the middle of November and will plan for commercial launch as early as the beginning of 2024.

Operator: In the upcoming quarters, we'll provide more clarity around market opportunities, launch expectations, and time. Thank you for your continued support of an interest in CoreMet. To ask a question, you may press star, then one, on your telephone keypad. If you're using a speaker phone, please pick up your handset before pressing the key.

Operator: To withdraw your question, please press star, then two. At this time, we will pause momentarily to sign our roster. And the first question will be from June Lee, from Truest Securities. Please go ahead. Good evening, this is Leson from June.

Leszek Sulewski: Thank you for taking my questions. First, what would be the protocol with the FDA for when you are ready to add in CML number two? Um, Thank you, Les.

Joseph Todisco: I think our current plan for the additional CMO would be, presumably, post-approval of the NDA, submitting it as a supplement. That's the current plan. Got it.

Joseph Todisco: Can you talk a little bit more about the reasoning behind the vital fill rate change and why it's now been proposed in that earlier? Thank you. Well, you know, as we began doing additional market research engaging on the inpatient and outpatient side, we saw a preference for a smaller vial fill that they would tap only one time, as opposed to the 5ML that they would tap twice. If we had pursued the original Hepperin API supplier only, we would probably get approval for the 5ML and then submit the 3ML as a supplement. But given that the agency wanted multiple sources of heparin, it made sense to include it. Got it, that's helpful. I just want more for me.

Joseph Todisco: Can you talk a little bit more about the strengths of the newly issued patent and perhaps handicap the exclusivity timeline that you expect? And also, as a follow-up to that, what would be your strategy to deal with any potential and filer? Okay, thanks for us. Yeah, actually, I mean, we do think the newly allowed claims are very meaningful. We think that once a patent's issued, it's going to be eligible to be listed in the Orange Book, right?

Joseph Todisco: Which means that generic filers would have to certify against it, right, if it's on the Orange Book List and post-expiration of the 10 and a half years of marketing exclusivity, right? This could be a material barrier to generic competition. So, generic versions of injectable solutions have to demonstrate that they're quantitatively and qualitatively the same in terms of inactive ingredients in order to obtain a designation from the FDA as substitutable.

Joseph Todisco: In our view, it's going to be very difficult for generics to design around these patent claims while also demonstrating substitutability. We feel good about the patent claims. In terms of, the second question you were asking about the A&A process? Can you clarify that question? Yeah, I guess your strategy, your legal defense strategy, to deal with any potential NDA filers that you might come across. I think we've seen that recently in the industry happen at an early stage of launch. So it can't really happen at the early stage. So let's clarify a couple of things. Because we have NCE exclusivity on related to Teraldean, the Turologene component of Defendcast, that NCE exclusivity means.

Joseph Todisco: that a generic filer who's not challenging our patent can't even submit an application for five years, while one that is challenging the patent can submit it in four years. So we've got quite a lot of time before someone can even submit an application. And the 10 and a half years that we do have means, regardless of patents, an A&A can't be approved for 10 and a half years. So there's quite a lot of time between now and when I think we do need to comment on IP litigation strategy, let's say. Got it, very helpful. Thank you. Thanks, love.

Operator: And again, if you have a question, please press star and then one. The next question will be from Serge Ballinger from Needham and Company. Please go ahead. Hi, good afternoon.

Serge D. Belanger: A couple questions for us. I guess first on the ENTAP reimbursement. I think the most recent, Incrual, included a 20% bump on the prior total that was approved. So just curious what drove that significant bump and how does that price level for, how does that reimbursement level kind of inform your pricing for the outpaces? Okay, thanks. So in terms of the NTAP and the application, migrating from the 5ML to the 3ML essentially meant that for each patient, you're getting two, three-millimeter vials, which is six millimeters of liquid, so the amount of liquid disp

Joseph Todisco: So that's a large portion of the increase in the 19 and a half vials as opposed to nine and a half that were in the original N-type application. So that drives most of the change in the NTA. The second part of your question was around outpatient pricing. Yeah, it's the Entap reimbursement. Okay, how does that work?

The second part of your question was around outpatient pricing.

Yes, it does.

And to have reimbursement, okay. How does this person yet.

Yeah, I would say that.

Joseph Todisco: Yeah, I'd say that they're not necessarily related, right? We're still working on what the outpatient and inpatient pricing strategy is going to be, right? So we have an NTAP, which is reimbursement to the healthcare institution, but it may not necessarily be reflective of what the true net price is going to be, right, for the institution. And I mean, we've said on the outpatient side, net pricing is going to be materially lower, right? So we're not going to guide you today as to just how much lower and where we see that going.

They're not necessarily related right, we're still working on what the outpatient and inpatient pricing strategy is going to abate right. So we have an end cap, which is reimbursement to the health care institution, but it may not necessarily be reflective of what the true net prices going to be right to the institutions we serve.

On the outpatient side and that pricing is going to be materially lower right. So we were not.

Got a guide today as to just how much lower than where we see that going but we understand it's there are different therapeutic segments.

Joseph Todisco: But we understand it's, there are different therapeutic segments, different patient, you know, sized patient population. So the pricing is going to be different in those two settings. And just thinking ahead of product launch early next year, especially in the inpatient setting, how should we think about the kind of trajectory?

Different patient size patient population. So the pricing is going to have to be.

Different in those two settings.

Okay, and just thinking ahead of.

Our product launch early next year, especially in the in patient setting.

How should we think about kind of the trajectory do you expect.

Joseph Todisco: Do you expect? It's, um, facility will do pilot studies and economic studies before they implement or incorporate the product as part of the practice? Look, I think, you know, right now we're having a lot of conversations with institutions about what's going to be required to work through the P&T process. You know, I think with the initial phase of the launch, it's going to take some time to work through the P&T process for each system.

Each.

Facility will do pilot studies and economic studies before the.

<unk>.

Implement or incorporate the product that's part of the practice.

Well look I think right now, we're having a lot of conversations with institutions of what's going to be required to work through the P&C process.

I think with the initial phase of the launch it's going to take some time to work through the P&C process for each system, some are going to be faster than others.

Joseph Todisco: Some are going to be faster than others; obviously, the conversations and partnerships we're pursuing right now are going to lay the groundwork for a better law. You know, I think Aaron, do you want to provide any more color?

Obviously, the conversations and partnerships we are pursuing right now are going to lay the groundwork for a better March.

No I think Aaron do you want to provide any more color.

Erin Mistry: Sure, thanks, Joe. Yeah, to that point, we have had and are running parallel strategic partnership discussions as well as, obviously, a full commercial launch. It's dependent on the institution, right? Some are a heavier list than others, and that's part of the segmentation and analytics that we're running.

Sure. Thanks, Joe.

To that point.

We're running in parallel strategic partnership discussions as well as obviously a full commercial launch it's dependent on the institution Reits are a heavier lift than others and that's part of the segmentation and analytics that we're running right now to understand who will do people want to do pilots, who will take us for face value.

Erin Mistry: Right now, we need to understand who will do it, who will want to do pilots, who will take this for face value, what's the ease of getting on formulary, and frankly, where are the relationships, right? the physician champions that can help shepherd that process through. So to answer your question, it's institution dependent.

What's the ease of getting on formulary, and frankly, where the relationships right. The physician champions that can help shepherd that process through that is to your quest to answer your question its institution dependent.

Serge D. Belanger: Okay. Thank you. Thanks, sir.

Okay. Thank you.

Thanks Serge.

Monique Cossey: And ladies and gentlemen, at this time, I'd like to turn the call back over to Monique Cossey for additional questions from our audience. Thank you, operator. We'll now go, we did get some questions in, written questions, and I will read those questions here. Okay, the first question: there are a couple parts to it. When would you expect FDA to inspect your CMO1 and why do you think the outcome will be different this time? What's changed?

And ladies and gentlemen at this time I would like to turn the call back over to the coffee for additional questions from our audience.

Yeah.

Thank you operator, well now go get some since then right.

Great questions and I will read those questions here.

Okay. The first question, there's a couple of parts to it.

When would you expect FDA to respect your CMO, one and why do you think the outcome will be different this time, what's changed and does the CMO have any other NDA is pending.

Joseph Todisco: And does the CMO have any other NDAs pending? Thanks, me neat. That's a good question. I think in terms of what might be different this time. You know, in the last eight months, we've seen a significant increase in the engagement of the CMO with external consultants. And those consultants have deep FDA experience. So we're encouraged by what we've seen in terms of corrective action implementation and, you know, those corrective actions that came out of the original inspection, and we're optimistic that they are ready for potential PAI re-inspection now.

Okay. Thanks Nathan.

Good questions.

I think in terms of what might be different this time.

The last eight months, we have seen significant increase in engagement of the CMO with external consultants and those consultants have deep FDA experience.

So we're encouraged by what we've seen in terms of our corrective action implementation and.

The corrective actions that came out of the original inspection and were optimistic that they are ready for a potential reinspection.

Joseph Todisco: So that said, we don't own the CMO, so all we can do is provide support, and once we do have a PAI date, we can also use our best efforts to do final preparation for inspection and, post any inspection, help them address any new observations that could arise. But I think we're optimistic with what we've seen from the site in terms of implementing corrective action. In terms of other NDA filings, we've been told that they have other NDAs pending from different sites in Western Europe that could potentially get a PAI before we do.

Re inspection now.

That said, we don't own the CMO. So all we can do is provide support and once we do that.

Yeah.

Also use our best efforts to do final prep for inspection and post earnings inspection help them addressing new observations that could arise, but I think we are.

Optimistic with what we've seen from the site in terms of implementing corrective actions.

In terms of other NDA filings.

Been told that they have other NDA spending from different sites in western Europe that could potentially get a P. I before we do so we're certainly going to be in close contact with them to understand any FDA observations that our facilities or anything that could impact our application.

Joseph Todisco: So, you know, we're certainly going to be in close contact with them to understand any FDA observations at other facilities or anything that could impact our application. Okay. Thank you. All right, another question from the audience.

Okay. Thank.

Thank you.

Alright, another question here.

The audience can you provide more color on that.

Joseph Todisco: Can you provide more color on why the FDA wanted two sources of Heparin in the application? And what will happen if the initial supplier of heparin has not resolved its warning letter before your target action date? Okay, thanks. I think the first part of that question, I think Phoebe did a good job addressing the script, but, you know, it's pretty straightforward.

Why the FDA wanted two sources that have been in the application and what will happen. If the initial supplier of heparin has not resolved its warning letter before your target action dates.

Okay. Thanks, I think the first part of that question I think <unk> did a good job of addressing the script, but.

It's pretty straightforward, we were hoping to get a class one submission with the original heparin source.

Joseph Todisco: We were hoping to get a class one submission with the original Heparin source, given that the CMO and the API supplier had rectified the compliance concerns, or in our view, rectified the compliance concerns. But during the FDA meeting, I think the agency strongly encouraged us to submit data from our new source of heparin, but also include the existing heparin data to give them more time to evaluate that site's compliance. I think, you know, should we get to our target action date and the FDA has not yet resolved that warning letter, we're free to withdraw that Heparin supplier and only go with the new source if that's what's needed to pursue approval. Okay, okay. Thank you, Joe.

Given that the CMO and the API supplier had rectified the compliance concerns.

In our view had rectified the compliance concerns, but during the FDA meeting I think the agency strongly encouraged us to submit data from our new source of heparin.

But also include the existing heparin data to give them more time.

To evaluate that site's compliance.

I think should we get to our target action date, and the FDA has not yet resolved that that warning letter were free to withdraw that heparin supplier and only go with a new source of IFF.

If if that's what's needed to pursue approval.

Okay.

Okay. Okay. Thank you Joe.

And our last question here from the audience. How are you thinking about the timing of ramp up our field based personnel.

Joseph Todisco: And the last question here from the audience: how are you thinking about the timing of the ramp-up of field-based personnel? And is there a scenario where you hire the field team ahead of NDA approval? And how about on the medical side?

And is there a scenario where you hire the field team ahead of NDA approval.

And how about on the medical side.

Joseph Todisco: Okay, yeah, I guess we think about commercial medical a little bit differently, so let's assume that we get a Purdue date that's in mid-November. There are going to be milestone events that happen along the course of the summer and early fall that could give us confidence, right, to hire more commercial personnel at risk. I think most importantly, any PAI inspection the FDA could do at our CMO, right, that bolsters our confidence. As I mentioned in the script, you know, we're already adding key leadership positions across functions.

Okay.

Yes, I guess, we think about commercial medical a little bit differently, so let's assume that.

We get a <unk> date.

Mid November .

There's going to be milestone events that happen along the course of the summer.

In early fall that could give us confidence to hire more commercial personnel at risk I think most importantly, any inspection the FDA could do it at our CMO right that that bolsters our confidence.

As I mentioned in the script, we're already adding key key leader positions across functions.

Joseph Todisco: But when it comes to the, call it the key, the field-based key account managers, ideally, what we would want to do is have those personnel identified and with all letters in hand around the time of a potential approval, and then onboard them immediately after. And that's certainly what we're going to try to do. On the medical side, it's a bit different.

But when it comes to the call it the key that our field based key account managers.

What we would want to do is have those personnel identified with often letters in hand.

Around the time of a potential approval in and onboard them immediately after.

That's certainly what we're going to try to do on the medical side, it's a bit different we really need to have the.

Joseph Todisco: We really need to have the full team staffed ahead of any potential approval. We have four MSLs on board right now. Those are medical science liaisons, and we'll probably seek to have around eight at the time of launch. So these roles are critical, as they can have medical professional to medical professional types of conversations with physicians around disease state awareness where commercial personnel are much more limited in what they can discuss, and we're not permitted to do any pre-approval marketing of the product. Regardless, to be successful, we're going to need to recruit qualified, capable people on both sides of the business.

<unk> staffed up ahead of any potential approval.

Four MSL are on board right now those are medical science liaison.

We seek to have around eight at the time of launch. So so these roles are critical as they can have.

Medical professional to medical professional types of conversations.

With physicians around disease state awareness, where commercial personnel are much more limited.

And what they can discuss them, we're not permitted to do any any preapproval marketing.

Got it.

Regardless to be successful.

We're going to need to.

Recruit qualified capable people on both sides of the business.

Joseph Todisco: Chief Formulary Access, contract appropriately, and then get channel pull through. Okay. Okay, thank you. And that does conclude that there are no further questions written online here. I'll turn it back over to the operator. Now, to close the call. Absolutely, thank you. And this concludes our question and answer session, and thus, today's call. We thank you very much for attending today's presentation. At this time, you may not disconnect your devices. Take care.

Chief formulary access contract appropriately and then get channel pull through so okay.

Okay.

Yeah.

Okay. Thank you and that does conclude that there are no further questions here.

Written online here I'll turn it back over to the operator.

Now to close the call.

Absolutely. Thank you and this concludes our question and answer session and thus concludes today's call. We thank you very much for attending today's presentation. At this time you may now disconnect your lines take care.

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