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spk05: and welcome to CoreMedix Inc. Second Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A brief 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, Dan Ferry, from LifeSci Advisors. Thank you, Mr. Ferry. You may begin.
spk08: Good morning, and welcome to the Corps Medics second 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 Mounts, EVP and General Counsel, Liz Hurlburt, EVP of Clinical and Medical Affairs, and Aaron 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 meeting 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, an NDA approval for DefendCath in the U.S. or other product candidates, future financial position, future revenues and projected costs, and reimbursement and potential market acceptance of DefendCath or other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, progress, results, estimates, and interpretations thereof, projections as to the company's future capital raising and spending and cash position, including projections regarding the sufficiency of the company's current cash resources to potentially bring the company through to break even profitability, expectations as to the timing and nature of anticipated regulatory actions, reimbursement decisions, possible product licensing, business development or other transactions, any commercial plans and expectations, intellectual property protections for our product candidates, market projections for our 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 Chromatic Filings with the SEC including the latest quarterly report on Form 10-Q and the annual report on Form 10-K, copies of which were available free of charge at the SEC's website at www.sec.gov or upon request from CoreMedix. CoreMedix may not actually achieve the 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.
spk04: Thanks, Dan. Good morning, everyone, and thank you for joining us on this call. Over the last three months, the company has announced a number of key milestone achievements. Most importantly, the announcement that the NDA for DefendCat had been resubmitted to the FDA following a Type A meeting and was subsequently accepted for review with a target action date of November 15, 2023. Phoebe will provide a brief update today on regulatory affairs activities leading up to our action date. In addition to the resubmission, we announced that the Center for Medicare and Medicaid Services, or CMS, issued its Inpatient Prospective Payment System proposed 2024 rule that included an NTAP of up to $17,111 per hospital stay for reimbursement of the FENCAS. We're happy to now announce that this past week, TMS published its final rule in this regard, providing for final approval of the NTAP of up to $17,111 per hospital stay for DefendCath reimbursement, conditioned upon the DefendCath NDA obtaining FDA approval prior to July 1st of 2024. The company also announced that the US Patent and Trademark Office had issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduce blood flow in central venous catheters. CoreMedix has paid the issue fee and the application has now moved to issuance. This newly allowed U.S. patent application reflects the unique and proprietary nature of DefendCast 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 an FDA approval of the DefendCast NDA. As a reminder, the 10 and a half years of marketing exclusivity anticipates five years of new chemical entity exclusivity plus five years of QIDP exclusivity plus six months of additional exclusivity for conducting a post-approval pediatric study. During that 10 and a half year exclusivity period, the FDA would be barred from approving any ANDA that references the PhenCas as its comparator drug. More recently, The company announced the pricing of an underwritten public offering of its common stock and pre-funded warrants in which the total gross proceeds before fees and expenses were approximately $40 million. In addition, we are pleased to announce today that the underwriters fully exercised the over-allotment option of approximately 1.5 million shares, yielding additional gross proceeds of roughly $6 million before fees and expenses. The successful completion of this financing provides CoreMedix with considerable medium- to long-term financial resources. The proceeds from the offering, together with our existing cash, cash equivalents, short-term investments, and available resources, will enable us to fund the launch of DefendCast through to anticipated profitability, assuming we are able to obtain a timely approval of the DefendCast NDA on our target action date. and commence commercial launch in the first quarter of 2024, as well as achieve other internal base case assumptions. This financing also added new institutional investors to our shareholder base and broadened our relationships across Wall Street. I will now turn the call over to Phoebe for a brief regulatory update and to discuss progress toward potential FDA approval. Phoebe?
spk01: Thanks, Joe. Good morning, everyone. As Joe mentioned, following the resubmission of the DefendCath NDA, the FDA accepted the application for review and granted a target action date of November 15, 2023. Over the past few months, we have received standard communications and requests for information from the agency related to our application consistent with a normal NDA review process, as well as notifications from various vendors of pre-approval inspections being scheduled for the product by FDA. As part of the review process, we anticipate an FDA pre-approval inspection of our primary contract manufacturing organization site in the coming months, which will be critical to approvability of the product. CoreMedix technical operations, regulatory, and quality teams, as well as multiple external DGMP consultants with deep FDA experience are in regular communication with the primary CMO team working towards the goal of preparedness for an upcoming pre-approval inspection. Ahead of any API, we are heavily focused on verifying the effectiveness of past corrective actions and working with the CMO team to confirm the readiness of the site for FDA inspection. Going forward, the company will share additional regulatory updates when appropriate. I would now like to turn the call over to Matt, who will provide a financial update. Matt?
spk09: Thanks, Phoebe, and good morning, everyone. I am pleased to be here today to provide an overview of our second quarter and first half of 2023 financial results, as well as an update on CoreMedix's cash position. The company has filed its quarterly report on Form 10-Q, for the quarter ended June 30th, 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 second quarter 2023 financial results, our net loss was approximately 11.3 million or 25 cents per share compared with a loss of 7.6 million or 19 cents per share in the second 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 second quarter of 2022. Operating expenses in the second quarter of 2023 increased approximately 43% to $11.8 million compared with $8.3 million in the second quarter of 2022. R&D expense increased by approximately 49% to $4.8 million, driven primarily by an increase in costs related to the manufacturing of DefendCap prior to its potential marketing approval, an increase in personnel expenses, and an increase in costs related to medical affairs activities. SG&A expense increased approximately 39% to $7 million in the second quarter of 2023, compared with $5.1 million in the second 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, and an increase in personnel expenses due to additional hires, partially offset by a decrease in legal fees for the period. With respect to our first half of 2023 financial results, Total operating expenses for the first half of 23 amounted to $22.8 million, compared with $15.3 million in the first half of 2022, an increase of 49%. R&D expense increased 49% to $8.2 million, driven primarily by an increase in personnel expenses, an increase in costs related to the manufacturing of the FEMCAS prior to its potential marketing approval, and an increase in costs related to medical affairs activities. SG&A expense increased approximately 49% to $14.6 million compared with the first half of 2022, primarily driven by an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefendCast, an increase in personnel expenses, and an increase in non-cash charges for stock-based compensation. These increases were partially offset by a decrease in legal fees for the period. We recorded net cash used in operations during the first half of 2023 of $19 million, compared with net cash used in operations of $12.2 million in the first half of 2022. The increase is primarily driven by an increase in net loss, primarily attributable to an increase in operating expenses as compared to the same period in 2022. With the recent closing of our announced equity offering, Cormetics is in a strong position from a balance sheet perspective. The company has cash and cash equivalents of $52.4 million as of June 30, 2023. This includes approximately $5.3 million raised during the second quarter of 2023 through our ATM program. Including approximately $43.2 million in net proceeds from our equity financing that closed during July, Cormetics has June 30, 2023 pro forma cash and equivalents of approximately $95 million. We believe our cash, cash equivalents, short-term investments, and available resources gives the company flexibility to fund the potential commercial launch of DefendCath through to anticipated profitability. Assuming we are able to obtain a timely approval of the DefendCath NDA on our target action date and commence commercial launch in the first quarter of 2024, as well as achieve other internal base case assumptions. I will now turn the call back over to Joe for closing remarks. Joe?
spk04: Thanks, Matt. Certainly, it's been a busy quarter for Corps Medics, a pace we expect to continue over the next few months. While our technical and regulatory teams are working diligently to help prepare our CMO for an upcoming pre-approval inspection, our commercial and medical affairs teams are engaging with key stakeholders across settings of care in an effort to ensure Corps Medics is well positioned for a potential launch of the FENCAS in early 2024. We were happy to announce last quarter our strategic partnership with Boston Medical Center, and we hope to announce similar arrangements with other health systems in the upcoming months. We are also pleased to have secured inpatient reimbursement via the conditional NTAP published by CMS last week, and we are preparing for an expected discussion with CMS in late 2023 around outpatient reimbursement. As we have discussed on prior calls, we do not believe that DefendCast should be classified as a renal dialysis service. It is an infection preventative, which is not currently captured by any functional categories inside the existing ESRD bundle. Congress created the Transitional Drug Add-on Payment, or TdapA framework, to incentivize innovation in treating ESRD. We were pleased to see that CMS recently proposed expanding TdapA from two years to five years, as adequate reimbursement of innovative therapies is essential to improving health outcomes. Though we do believe Tdap is an adequate reimbursement structure for products that treat ESRD, we feel strongly that as an infection preventative, we intend to make our case to CMS that our product should always remain outside the bundle and should be reimbursed as an outpatient Part B drug product with a unique J code. A formal application for outpatient reimbursement cannot be submitted until after an NDA receives FDA approval. However, we do expect to engage in a dialogue with CMS ahead of that submission. providing the agency with documentation supporting our reimbursement position. CoreMedix is squarely focused on operational execution at this point in time, and I look forward to updating shareholders as we approach our target action date in November. Thank you for your continued support of and interest in CoreMedix.
spk03: Should I open the floor for questions? Yes, please.
spk05: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. The first question comes from the line of Jason Butler with GMP Securities. Please go ahead.
spk02: Hi, thanks for taking the questions and congrats on all the progress. I think Phoebe mentioned that there were multiple vendors that have been informed of or scheduled pre-approval inspections. Can you just give us any color as to whether any inspections have already occurred and if there's any update of the status of your primary API provider? And then secondly, now you have the final NTAP approval. Is there any work that you can do pre-approval in preparation of those reimbursement discussions with institutions? And what are the priorities post-approval? Thanks.
spk04: All right. Thanks, Jason. So on the NTAP, we'll hold that question a second. We'll start with Jason. the question around the primary API vendor. As of today, we don't have any update on the compliance status of that API vendor. I think what we said on the last earning call remains the case. The feedback from our type A meeting was that should the warning letter remain in place at the time of our action date, we have the ability to withdraw them as a vendor. Until we learn otherwise on the compliance status of the facility, that's the discussion we would intend to have. with the agency as we approach the action date. Phoebe, do you want to comment on any of the PAIs for other vendors?
spk01: Yes, sure. Thanks for the question, Jason. As you know, when you submit the NDA, there are a number of contract manufacturers, API suppliers, testing labs that are listed. and are inspected by FDA as part of the pre-approval process. FDA is working through contacting all of those entities to schedule the timing for the inspections. That does not go through core medics, so we're not involved in the coordination of the timing. We are aware that testing lab has been inspected and the inspection went well without any issues for defend caps. We do hope to get updates from all the various vendors as the inspections occur. But as I said, that's not something that we're directly involved with. Great.
spk04: Thanks, Phoebe. So, you know, Jason, on the NTAP side, that's specific to inpatient reimbursement. And, you know, we mentioned in the script, we've got a lot of ongoing, call them pre-commercial activities, both on the commercial side and on the medical side. You know, head of approval looking to put us in, you know, a stronger position as we, you know, would expect to ramp up for a launch. You know, on the inpatient side, you know, each health system has its own P&T process, right? So we're doing a lot of work now to put us in a stronger position with each health system. You know, Liz Hurlburt's on the line. I'm going to ask her to comment a little bit about what's going on in the medical affairs side, right, on specific to inpatient as we, you know, prepare for commercialization.
spk07: Thanks, Joe. In the past quarter, the field medical team has had numerous interactions with clinical stakeholders in nephrology, infectious disease, patient safety and outcomes, and infection prevention. And we are diligently learning the current protocols for hospitals and health systems and what they have in place when it comes to catheter care so we can best educate the clinical community based on their current practices. And along with the commercial team, we've also engaged in several mock P&T, or pharmacy and therapeutics meetings. And these meetings have provided us the opportunity to learn firsthand what is valuable to decision makers and has really underscored the clinical unmet need that remains for these patients.
spk02: Great. Thank you for taking the questions, and I'll get back to the progress.
spk03: Thanks, Liz. Thanks, Jason. Thank you.
spk05: Next question comes from the line of June Lee with True Securities. Please go ahead.
spk11: Hi. Thanks for the update and for taking our questions. As you look to the initial approval and launch, how should we be thinking about a ramp in SCNA? How many sales steps are you looking to onboard and the cadence of that?
spk04: You broke up a little bit while you were asking that question, but was this Les?
spk11: This is June.
spk04: Sorry, I couldn't hear you. You asked about the ramp of SG&A and the cadence for hiring reps. Is that what I heard? Exactly. Okay. Our thinking on this hasn't really changed much over the last quarter since we talked. We're not going to give specific dollar ramp guidance at this point in time, but the way you should be thinking about it, You know, we've grown over the last couple of months from, you know, 30-some-odd employees last year to about 46, 47 today. You know, we're adding employees at the management level right now in key functions. We've built out, you know, our medical affairs team, our field medical team. We're hiring leadership roles on the commercial side. When it comes to field-based personnel, you know, we wouldn't expect to actually onboard those personnel until we have an approval in hand, right? The goal would be to identify key candidates and have them with offer letters and then do the onboarding shortly after approval and work toward a launch in the first quarter of 2024, assuming we get approval on the action date. We've talked about an inpatient field team in the range of around 30, and I think that that assumption still holds. You know, on the outpatient side, we think it's a leaner team. You've got a much more consolidated customer base on that side of the business. So we've, you know, I think publicly talked about 12 to 14 on that side at around the time we launch on the outpatient side. And the outpatient is going to lag a little bit, right? We're waiting enough to wait on that outpatient reimbursement decision before we can really roll out a more robust outpatient launch. So, you know, as we get, you know, get a, approval in hand or, you know, if we get approval in hand, we'll be able to provide a little bit more specific guidance around timing and costs.
spk11: Perfect. And the final question is, you know, your strategic initiative with Boston Medical, that's really interesting. Is that sort of a real-world study? And if so, how will you be disclosing the result of that study? Can you just elaborate a little bit more on that?
spk04: Yeah, sure. Thanks, Jim. I'd like to ask Aaron to talk a little bit about the Boston Medical Partnership.
spk06: Sure. Thanks, Joe. So for BMC, we do plan on publishing in collaboration with them and any additional future partnerships that we have. The current data initiative is focused on just the retrospective data related to hemodialysis patients and catheter-related infections, and then we'll implement a a second phase two to this as post-approval to evaluate the real-world utilization of DefendCath and then compare that to what we looked at prior to the approval. This is very important for us from a commercial perspective. One, we get into the institution. We learn about the patient population a bit more. We learn how dialysis is provided by other organizations like our dialysis organizations that are in there. That is very important. And then we actually will have the data that we need to further support the product and drive your goals.
spk11: Got it. And my final question, congrats on getting that NTAP reimbursement in place for $17,000 and some odd dollars. hospital space they wanted to confirm that's strictly restricted to limited to the the hospital space related to diagnosis or is there any other opportunities uh to to for that so the the the ntap reimbursement is specific to utilization on label aaron do you want to elaborate a little bit more yeah
spk06: But just to that point, Joe, it is per label, so it's restricted to hemodialysis patients with CVCs on the inpatient side. Yeah, just on the inpatient side. But they've recognized that the agency, CMS, you know, it's not easy to get an NTAP, and so we've met that criteria, and so we're utilizing that for our benefit on the outpatient as we look to separate payments. as well so that's it's very helpful from us on both sides from a strategic standpoint um but that with the ntap already secured we have the ability it's a very unique ability to go into these institutions earlier right and have robust conversations from a financial and procurement perspective most companies have to wait to approval where you have um you know you have your price at that point and then they understand the reimbursement a little bit better So we are able to make that process more efficient and earlier.
spk11: Fantastic. Just to follow up on that, is there like a cap on how many hospital stays that they will reimburse for? If you do meet the criteria, they will reimburse $17,000 for all eligible dialysis-related hospital stays.
spk06: Erin, go ahead. Yeah, so the NTAP works, it's over and above the DRG. So once a DRG is maximized, so let's just take a DRG, let's say it's $10,000 for an inpatient stay, an NTAP is over and above that amount. And so the maximum amount that they can get per stay, per hospital stay, is $17,111. And maybe that patient goes in several times in a year if they max out their DRG. And every hospital has different calculations for this. on how they do it, but the hospital can receive up to that amount for each day.
spk03: Great. Thank you. I'm looking forward to the updates. Thanks, June.
spk05: Thank you. Next question comes from the line of Rohit Basim with Needham & Company. Please go ahead.
spk10: Hi, thanks for taking our questions. This is Rohit on for surge. Can you talk about what the current treatment guidelines are at hospitals to reduce CRBS size and do you expect to defend cats to be a part of them? And then second question, are there any similar recent drug launches that could provide a proxy for a potential launch trajectory of defend cats? Thanks.
spk04: Thanks, Rohit. You know, in terms of the first question on kind of current treatment guidelines, I'm going to ask Liz to comment. Sure.
spk07: Thanks, Joe. So there are a variety of national guidelines that are available from CDC and SHEA and a number of other national organizations. And then on an institutional basis, they are coming up with their own protocols based on the needs of their patients and the way they take care of certain types of catheters can vary. Currently, what we've learned is in addition to performing hand hygiene and cleaning the skin with an antiseptic and ensuring that healthcare providers are gloved and there's not cross-contamination and all of the regular precautions that are taken to keep the line safe, there are a number of different unapproved catheter locks that may be utilized at different times. They tend to be more reactive than proactive or preventive in most cases. But there are a variety of different things institutions are doing. But unfortunately, that is one of the gaps right now is there is not a clear, consistent guideline on how to best reduce infections in this population.
spk04: Thanks, Liz. And in terms of your question on similar drug launches, I think this is something that we struggle to find a pure play comparable. And we think that's actually a good thing. So what we're looking to launch here is truly a first-in-class therapy. It is a preventative, right? We're not a product that's out treating infections. We're looking to prevent infection. And to our knowledge, no real similar product has launched either in the inpatient space or in the outpatient space. So we think that that's certainly a good thing. We think there's a lot of reasons why you know, our NTAP and, you know, will be meaningful on the inpatient side where perhaps some, you know, it wasn't as meaningful for some next generation cephalosporins and antibiotics that got approved that were competing against, you know, five, six different products for the same therapy, right? So we are, you know, right now there's no currently FDA approved drug products for the prevention of CRBSIs in any population, including the hemodialysis population. So we're looking at this truly as a first-in-class therapy.
spk03: Great. Thank you.
spk05: Thank you. I will now turn the call over to Dan Ferri for additional written questions from the audience.
spk08: Thank you, Operator. Jay, we have a couple questions here from the audience. The first one is, can you elaborate on the recent changes regarding Tdapa in extending the program?
spk04: Sure, and obviously I'm going to want to reiterate the comment that while we do think Tdapa is adequate for reimbursing innovative products that treat ESRD, a lot of our focus is on working with CMS for separate reimbursement. That said, we were happy to see them extend to DAPA. It was two years. They've added an additional three years of reimbursement. And I think that that recognizes that longer reimbursement is necessary to begin addressing a lack of innovation in that ESRD space. So beyond that, Aaron, is there anything else you'd want to add on the changes?
spk06: I think you covered it. I mean, I think the additional three years just helps create a better incentive for providers to utilize new therapies, right? So good thing for us, the agency has recognized that the innovation around the innovation post-EDAPTA, and we look forward to working with them on the payment specifics if we go that route.
spk08: Excellent. All right. Thank you, Joe. Thank you, Erin. Joe, another one here. Can you comment on future financing strategy? especially in light of the disclosure around this recent financing, having the possibility to take the company to break even profitability.
spk04: Thanks, Dan. Matt, do you want to comment on financing?
spk09: Sure. Sure. Thanks, Joe. Yeah, as in the past, we can't really comment on plans for future financing. CoreMedics management and our board regularly evaluates our needs, market conditions, and various strategies as we proceed. I will say that we completed the recent equity offering to really put the company in a strong financial position as we plan for and ramp up toward the potential commercial launch of DefendCast.
spk08: Excellent. Thanks, Matt. Thanks, Joe. Operator, this concludes the question and answer session. You may now close the call.
spk05: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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