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spk05: Good afternoon and welcome to the CoreMedix 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 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 now like to turn the conference over to Monique Cossie. Please go ahead.
spk07: Thank you. Good afternoon, everyone, and welcome to the CoreMedics First Quarter 2023 Earnings Conference Call. Leading the call today is Joe Tedisco, Chief Executive Officer of CoreMedics, and he is joined by Dr. Matt David, Executive Vice President and CFO of Dr. Phoebe Mounts, EVP and General Counsel, and Erin Mistry, 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 set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include but are not limited to any of the following. 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 DFINCAP in the U.S. or other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of DFINCAP 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 position, expectations 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. 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 10-Q and annual report on Form 10-K, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from Corps Medics. Corps 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. Please note that CoreMedix 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 CoreMedix. Joe, please go ahead.
spk03: Thank you, Monique. Good afternoon, everyone, 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 DefendCat 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. CVE 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 2 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 DefendCast. The first was that following our submission of a duplicate new technology add-on payment, or NTAP, application in the fourth quarter of 2022 to the Centers for Medicare and Medicaid Services, CMS has now issued the Inpatient Prospective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefendCat. 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-milliliter vial, with an average utilization of 19.5 vials per hospital stay. As we mentioned in our recent update, CoreMedix will be migrating DefendCath from a 5 milliliter to a 3 milliliter vial volume based upon market preferences. 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. This NTAP is conditioned upon the DefendCath NDA obtaining final FDA approval prior to July 1st of 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 DefendCath 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 exclusivity available upon an FDA approval of the DefendCat NDA. Once this patent is granted, we plan to seek listing in FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, which identifies approved drug products and includes related patent and exclusivity information as part of the NDA 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 CoreMedix is in position to maximize the value of Defencas. 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. 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 PhenCas utilization in the system can be quantified. On the outpatient side, we have also intensified engagements with potential customers and stakeholders as we prepare for discussions with CMS related to outpatient reimbursement. Catheter-related bloodstream infections remain one of the most severe complications associated with receiving hemodialysis through a central venous catheter. and adequate reimbursement to dialysis 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, providing the agency with documentation supporting our reimbursement position over the upcoming months. I will now turn the call over to Phoebe to discuss our Type A meeting with FDA and potential timelines for FDA approval. Phoebe?
spk09: 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 Defend-Cath NDA as soon as possible. As you know, Core Medics received a complete response letter in August of 2022, due solely to deficiencies cited at contract manufacturers of active pharmaceutical ingredient, and finished product, but citing no DEFENCAS 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 have discussed during the last two earnings calls. In March, we submitted a Type A meeting request to FDA discussed plans for 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 one that would utilize our existing CMO and existing API supplier to support a class one resubmission with a 60-day review period. The discussion with FDA related to pathway one was very positive and productive. However, based upon FDA's feedback, it was apparent that core medics would be better served by resubmitting the NDA, not only with our existing CMO, but incorporating multiple sources of heparin 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 2 resubmission with a six-month review period. We view the discussion with FDA as highly valuable, and following our receipt of the formal meeting minutes from this discussion, CoreMedix 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 PDUFA target action date in November. As Joe mentioned, Corps Medics 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?
spk01: Thanks, Evie, 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 CoreMedix's cash position. The company has filed its quarterly report on Form 10-Q with a quarter ended March 31, 2023. 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, Our 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. 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 marketing approval. These increases were partially offset by a decrease in consulting fees for the period. SG&A 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 DefendCast. an increase in personnel expenses due to additional hires, and an increase in non-cash charges for stock-based compensation. These increases were partially offset by decreases in legal fees for the period. We recorded net cash used in operations during the first quarter of 2023 of 10.4 million, compared with net cash used in operations of 6.7 million for the first quarter of 2022. CoreMedix remains in a good position from a balance sheet perspective. The company has cash and cash equivalents of $55.6 million as of March 31, 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 first quarter 2023, CoreMedix has March 31, 2023 pro forma cash and equivalents of approximately $59.3 million. We believe our cash and cash equivalents 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 the FENCAT. I will now turn the call back over to Joe for closing remarks. Joe?
spk03: Thanks, Matt. As I mentioned earlier, I believe the company is executing well on our key objectives, and we now increase 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'll 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. In the upcoming quarters, we will provide more clarity around market opportunities, launch expectations, and timing. Thank you for your continued support of and interest in CoreMedix.
spk05: We will now begin our question and answer session. 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 keys. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. And the first question will be from June Lee from Truist Securities. Please go ahead.
spk02: Good evening. This is Les from June. Thank you for taking my questions. First, what would be the protocol with the FDA for when you are ready to add in the CMO number two?
spk03: Thanks, Les. I think our current plan for the additional CMO would be presumably post-approval of the NDA submitting it as a supplement. And that's the current plan.
spk02: Got it. Can you talk a little bit more about the reasoning behind the vial fill rate change and why now this has been proposed and not earlier? Thank you.
spk03: Well, as we began doing additional market research out 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 5 ml that they would tap twice. If we had pursued the original Heparin API supplier only, we would have probably gotten approval with the 5-ML and then submitted the 3-ML as a supplement. But given that the agency wanted multiple sources of Heparin, it made sense to include it in the submission.
spk02: Got it. That's helpful. Just one more for me. Can you talk a little bit more about the strength 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 end-of-filers?
spk03: Okay. Thanks, Les. 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, which means that generic filers would have to certify against it, right, if it's Orange Book listed. And post-expiration of the 10 and a half years of marketing exclusivity, 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. In our view, it's going to be very difficult for generic to design around these patent claims while also demonstrating substitutability of the FDA. So we feel good about that. about the patent claims. The second question was you were asking about the ANDA process. Can you clarify that question?
spk02: Yeah, I guess your strategy, your legal defense strategy to deal with any potential ANDA filers that you might come across. I think we've seen that recently in industry happen at an early stage of launch.
spk03: It can't really happen at the early stage. Let's clarify a couple of things. Because we have NCE exclusivity on on related to tyrolodine or tyrolodine component of defendcast that nce exclusivity means that a generic filer who's not challenging our patent patent can't even submit an application for five years uh one that is uh challenging the patent can submit it uh in four years so we've got quite a lot of time before someone can even submit um and the ten and a half years that we do have means, regardless of patents, an ANDA 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.
spk06: Got it. Very helpful. Thank you.
spk05: Thanks, Les. And if you have a question, please press star, then 1. The next question will be from Serge Ballinger from Needham and Company. Please go ahead.
spk04: Hi, good afternoon. A couple questions for us. I guess first on the NTAP reimbursement, I think the most recent approval included a 20% bump on the prior total that was approved. So just curious what drove that pretty significant bump. And how does that price level for, how does that reimbursement level kind of inform your pricing for the outpatient segment?
spk03: Okay. Thanks, Les. So in terms of the NTAP and the application, migrating from the 5 ml to a 3 ml essentially meant that we, for each patient, you're getting two 3 ml vials, which is 6 ml of liquid. So the amount of liquid dispensed increases so that's a large portion of the of the increase in the 19 and a half vials as opposed to nine and a half right that were in the original ntap application so that that drives the uh most of the of the change in the ntap uh the second part of your question was around outpatient pricing yeah if this ntap reimbursement okay how does it so yeah yeah i i'd say that uh they're not necessarily related. We're still working on what the outpatient and inpatient pricing strategy is going to be. 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 to the institution. We've said on the outpatient side, net pricing is going to be materially lower. So we're not going to guide today as to just how much lower and where we see that going, but We understand there are different therapeutic segments, different sized patient populations, so the pricing is going to have to be different in those two settings.
spk04: Just thinking ahead of a product launch early next year, especially in the inpatient setting, how should we think about the trajectory? Do you expect each facility will do pilot studies and economic studies before they implement or incorporate the product as part of the practice?
spk03: Look, I think, you know, right now we're having a lot of conversations with institutions of 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. Some are going to be faster than others and Obviously, the conversations and partnerships we're pursuing right now are going to lay the groundwork for a better launch. I think, Erin, do you want to provide any more color?
spk08: Sure. Thanks, Joe. Yeah, 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, right? Some are heavier lifts than others, and that's part of the segmentation and analytics that we're running right now is to understand 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.
spk06: Okay. Thank you. Thanks, Serge.
spk05: And ladies and gentlemen, at this time, I'd like to turn the call back over to Monique Cossie for additional questions from our audience.
spk07: 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's 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 does the CMO have any other NDAs pending?
spk03: Thanks, Monique. Those are good questions. I think in terms of what might be different this time, you know, the last eight months we've 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 corrective action implementation and those corrective actions that came out of the original inspection, and we're optimistic that they're ready for potential PAI reinspection now. 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 prep 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. So 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 applications.
spk06: Okay, thank you.
spk07: All right, another question here from the audience. 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?
spk03: 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. 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, 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 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.
spk07: Okay. Okay. Thank you, Joe. And the last question here from the audience, how are you thinking about the timing of 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?
spk03: Okay. Yeah, I guess we think about commercial medical a little bit differently. So let's assume that we get a Purdue for date that's in mid-November. There's going to be milestone events that happen along the course of the summer and early fall that could give us confidence 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 leader positions across functions. 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 offer 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. We really need to have the full team staffed up 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, achieve formulary access, contract appropriately, and then get channel pull-through.
spk06: Okay. Okay, thank you.
spk07: 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.
spk05: 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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