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spk03: Thank you for standing by. This is the conference operator. Welcome to the SC Pharmaceuticals third quarter 2023 earnings conference call. As a reminder, all participants are in listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to PJ Kelleher, LifeSite Advisors. Please go ahead.
spk06: Thank you, Operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements on this conference call, other than historical facts, are forward-looking statements within the meaning of the federal securities laws, including but not limited to statements regarding SC Pharmaceuticals' expected future financial results, and management expectations and plans for the business in Perosix. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are typically used to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other important factors that may affect Etsy Pharmaceuticals business financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceutical's annual report on Form 10-K, quarterly reports on Form 10-Q, and other reports filed by the company with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these four looking statements. Any forward-looking statements made in this conference call, including responses to your questions, are based on current expectations as of today, and SC Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John?
spk08: Thank you, PJ, and thank you to everyone listening to this afternoon's call and webcast. to review our third quarter 2023 results. This afternoon, I am pleased to provide an operational update before turning the call over to Steve Parsons, our Senior Vice President of Commercial, for a more detailed update on the Ferocix launch, and then Rachel Nodes, our Chief Financial Officer, for a review of our financials. We will then open the call for your questions. The third quarter of 2023 represents our second full quarter of Ferocix commercial availability. as we launched the product in late February. Demand has continued to grow, reflected in our key indicators, including number of prescriptions, number of total prescribers, and doses filled per prescription. Berosix is meeting the needs of heart failure patients suffering from fluid overload, and we believe specialists are quickly gaining comfort prescribing it. The third quarter, we reported net revenue of 3.8 million, representing a sequential increase of 138% from 1.6 million for the second quarter of 2023. This was driven predominantly by units shipped to patients through our specialty pharmacy network. Also captioning our net sales for the first time are the direct sales of Ferosix to multiple integrated delivery networks. As we mentioned last quarter, as sales to IDNs increase, we will be reassessing the KPIs that we report. Inventory levels at the end of the third quarter were consistent with the inventory levels at the end of the second quarter. Our gross and net discount from launch to the end of Q3 is running at approximately 21%, down from 23% through the end of Q2. We expect this to increase over time as contracting with payers evolves. In response to positive demand trends, we added an additional 12 sales territories towards the end of the third quarter. This brings our current field sales force to 66 territories, and we anticipate seeing the positive impact of these additions beginning in the fourth quarter. Shifting now to payers, we continue to have productive discussions with commercial, Medicare Part D, and Medicaid payers in a continuing effort to make Ferocix broadly available to patients at the most favorable terms possible. Indicative of our progress, in late October, we reached an agreement with one of the largest closed integrated delivery networks in the U.S., providing unrestricted access to Ferocix without prior authorization to over 8 million lives at a fixed copay ranging from $16 to $75 per prescription. Also, as of November 1, Ferosix has added on formulary as a preferred brand with one of the largest government retiree payer formularies, increasing the number of lives with preferred access to Ferosix by an additional 1.1 million lives. These payer decisions expand the population of heart failure patients who have access to Ferosix. and moves us towards our previously stated goal of having 75% or more heart failure patients nationally with fixed co-pays of $100 or less. We anticipate that this could positively impact Ferocik's co-pays as early as the fourth quarter. We are progressing with many other health plans, and we hope to have several more announcements like these in the months to come. Staying on the topic of payers for a moment, recall that we announced national Medicaid coverage for 06 effective July 1st. We have since added an additional specialty pharmacy to our network to maximize access to 06 in these states that require a waiver that we can address the needs of Medicaid heart failure patients as quickly and efficiently as possible. Turning now to our life cycle management initiatives. During the third quarter, we received FDA feedback on three key initiatives that we view as critical to our long-term growth strategy. In August, we announced favorable type C meeting feedback from the FDA regarding the potential expansion of the Ferosix indication to allow for use in New York Heart Association Class IV heart failure patients. Ferosix is currently indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association Class II and Class III chronic heart failure. We estimate that as many as 10% of all heart failure patients are Class IV And a meaningful percentage of these, as many as 40%, may benefit from furosics. If we are successful, Class 4 would represent a meaningful expansion of our market opportunity and would enable furosics to be prescribed to the most severe heart failure patients. Based upon the feedback that we received from the agency, we filed for the Class 4 indication in early October. More recently, we received type C feedback from the FDA pertaining to the development of an 80 milligram by 1 ml autoinjector intended to provide an additional option to the on-body infuser for treatment of congestion due to fluid overload in eligible adult patients who do not require hospitalization. We believe that an autoinjector, if successfully developed and approved, would reduce manufacturing costs compared to the current on-body infuser and confer environmental advantages. We plan to report data from a pivotal PK study in 2024, and if successful, we are targeting the submission of a supplemental new drug application to the FDA by the end of 2024. Finally, we announced feedback from a Type D meeting with the FDA pertaining to the potential expansion of the thoracic syndication to include treatment of edema due to fluid overload in patients with chronic kidney disease, or CKD. In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that we can demonstrate an adequate PK and pharmacodynamic bridge to the listed drug, which is furosemide injection 10 mg per ml. CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretic. It's estimated that 12 to 15 million Americans are aware that they have kidney disease, and 50% of patients with CKD do not have a diagnosis of heart failure. With fluid overload being one of the most common complications in CKD, which worsens with disease progression, we believe furosix to be beneficial to patients with CKD who have worsening symptoms due to fluid overload and are not responding to oral lip diuretics. plan to advance furosics as we work towards our goal of introducing a new treatment option for CKD patients with edema as efficiently as possible. At this point, I'll turn the call over to Senior Vice President of Commercials, Steve Parsons, for a deeper dive into our launch metrics. Steve?
spk09: Thank you, John. As John indicated, the third quarter was our second full quarter of furosics commercial availability, and we are pleased with our progress. Our results continue to be very encouraging in Q3. From launch through September 30th, we've had 1,119 unique prescribers, almost doubling from the 631 acquired through June 30th. During the third quarter, we had 1,579 total prescriptions written, and 877 of those prescriptions have already been filled. There were another 442 that were still pending as Q3 ended. Pending prescriptions are not canceled. They are still in process with the payers. Some are approved and waiting in a queue, while others are in prior authorization. We continue to fill more pending prescriptions written in Q3 into the filled category every day. There are some prescriptions that get canceled for various reasons. including unreachable patients who are hard to contact, have been hospitalized, or a small number that are now deceased. Of those that are reached who cancel, a high copay is the main reason given. In Q3, the percent of furosix prescriptions filled increased to 55% from 52% in Q2. We anticipate that the fill rate will continue to increase as cirrhosis is expected to become better positioned on more health plan formularies, lowering patients' out-of-pocket costs, and providing quicker coverage decisions. During the third quarter, the average number of doses per prescription filled was 5.6, which remains higher than our long-term expectations. Our Salesforce conducted 1,806 in-services as of September 30th, compared to 1,129 as of June 30th. In-services provide important training to offices on the prescribing process for furosics, and this ensures office readiness. As we open more new accounts, the execution of in-services remains fundamental to furosic success. We've said previously that we stand ready to add additional territories as demand warrants, and we did so at the very end of Q3. We added 12 territories, bringing our total field force as of today to 66 territories. It's important to note that the territories we added during Q3 were added towards the end of the quarter and as such did not contribute meaningfully to Q3 results. The new sales representatives are now trained and conducting face-to-face selling in cardiology offices. From a marketing perspective, we are engaged in a broad multi-channel marketing campaign to drive brand awareness, adoption, and commitment. This program encompasses many different activities, but some of the key ongoing activities include engagement and development of key opinion leaders, cardiology conference presence, print and electronic collateral, and the development of both provider and patient websites, among other critical tasks. We've also begun reaching out to heart failure patients and their caregivers with patient education materials for furosips. Overall, we are very pleased with our continued progress and the path that we are on. That concludes my update. I would like to turn the call over to our Chief Financial Officer, Rachel Noakes, for a financial update. Rachel?
spk01: Thank you, Steve. We generated net product revenue of $3.8 million during the third quarter of 2023, and the cost of revenue was $1.1 million, yielding a gross profit of $2.7 million. Research and development expenses were $3.4 million for the third quarter of 2023, compared to $3.7 million for the third quarter of 2022. The decrease in research and development expenses for the quarter ended September 30, 2023, was primarily due to a decrease in employee-related costs and clinical study and medical affairs costs. The decrease was partially offset by an increase in device and pharmaceutical development costs. Selling general and administrative expenses were $14.1 million for the third quarter of 2023. compared to $6.3 million for the third quarter of 2022. The increase in selling general and administrative expenses for the quarter ended September 30th, 2023, was primarily due to an increase in employee-related costs and commercial costs. We reported a net loss of $15.6 million for the third quarter of 2023, compared to $10.2 million for the third quarter of 2022. We ended the third quarter of 2023 with $90.2 million in cash, cash equivalents, and short-term investments, compared to $118.4 million as of December 31st, 2022. Finally, as of September 30th, 2023, SE Pharmaceutical's total shares outstanding was 35,859,045 shares. That concludes the financial update. John?
spk08: Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions.
spk03: Thank you. We will now begin the question and answer session. To join the question queue, you may press star, then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star, then two. The first question comes from Rowana Ruiz with Learing Partners. Please go ahead.
spk10: Hi, good afternoon. This is Nick Gassick on for Rowana.
spk04: Thanks for taking the question. Maybe first from us, could you discuss or talk a little bit about how we should think about the size and frequency of potential direct purchase agreements that could come from the IDNs in the future. And I guess to what extent could the IDN drive broader prescribing of 06 going forward? Another quick follow-up.
spk08: Sure, Nick. This is John. I'll let Steve talk, too. Yeah, you know, so in this last quarter, Q3, we did have direct purchases from IDNs. Didn't represent that much. You know, most of it was still going through a specialty pharmacy. We did sign up with the largest IDN here at the end of the quarter, and we anticipate that's going to be a meaningful part of our business. Now, keep in mind we have, in our internal forecast, have, you know, taken into account that we would receive that business. So, but I do think it's going to, especially starting, you know, this quarter and really into next year, be a meaningful part of the total revenue. And as I think we've said, and we try to articulate again, we can't see scripts or units per script. We sell that net to them, to their warehouse, and they'll distribute it to their hospitals throughout the country. But we do think it wasn't really that meaningful in this quarter, but moving forward, and especially in the next year, will be very meaningful.
spk10: Helpful. Thanks very much, John.
spk04: And then just a quick follow-up on the sales reps. So I guess how – you mentioned you added 12 territories in the quarter. How are you thinking about future sales rep additions going forward into 2024? You know, how might this flow through if your assets fail?
spk08: Yeah, so we – Again, we added another 12 reps at the end of the quarter that are just really hitting the field a little bit last month. You know, we've said all along that we plan to get to around 110 reps. So we haven't articulated yet when we'll make the next expansion, but it'll be next year, probably in the first half of next year, that we do another increase I think we want to absorb these, make sure we're still thinking of territories the right way, size of territories, the balance of cutting in territory that's a little big versus going into wide areas. So we're going to stay opportunistic, but I think you'd see more sales reps sit in the ground in the first half of next year.
spk10: Thanks. We'll hop back into queue.
spk02: Thank you.
spk03: The next question comes from Douglas Zhao with HC Wainwright. Please go ahead.
spk00: Hi, good afternoon, and congrats on the progress. I guess maybe as a starting point, you know, the units per script has continued to go up, and I think it's considerably, or not considerably, higher than what you anticipated. I think we had ahead of launch talked about four units per course of treatment, and it sounds like docs are maybe going with a little bit more. I'm just curious if there's any color in terms of what's been driving that. I mean, even since the launch, it's continued to sort of increase.
spk08: Hey, Doug, it's John. I'll let Steve handle that one.
spk09: Yes. So what we think is driving it is there aren't quantity limits. So the doctors are trying to optimize the number of doses they can get for patients. Also, the mix of our patients right now is more in the preventative pre-admission where there's more fluid to get off than if there was a higher proportion that were being discharged after already being treated. They might not need as many doses if they got into trouble again. We think it may continue to increase incrementally in the short run. but we also think it'll moderate down back into the four to five dose range as quantity limits or utilization management are required by some of the payers. Like, for example, there's a few Medicaid states right now where they have a quantity limit of four doses. UnitedHealthcare Commercial which we announced last quarter, they have a quantity limit of four doses per Rx. Now, they can write another prescription in the same month, but per Rx, four doses. So, we think it might come down a little bit over time.
spk08: And I think we're also seeing, you know, the usage in the pre-admission stage where I think you're going to see more, a higher script level. The other thing I think if you look at, Doug, if you look at our GTN, at 21%, which is great. It's a bit of a double-edged sword because we're not paying rebates to some of the plans that want rebates. But we do anticipate soon we'll come on formulary with a number of those, and that will drive that GTN up. Obviously, lower co-pays, improve adjudication time, make more access to more patients. but also probably have a shrinking effect on the number of units per script. But I think our thinking now is a little different. We think it moderates, but still stays in the 4.5 to 5 range, where I think our guidance previously had been 4. We're just seeing doctors be a little more aggressive treating patients than we originally had anticipated.
spk00: Okay, great. That's really helpful, Kolar. And then just in terms of how the IDNs plan to use the product, is it going to be different than sort of the individual physicians and heart failure clinics?
spk09: Yeah, since an IDN is responsible for medical costs and drug costs, they take the whole burden. For them, it makes sense to use it anywhere they can to, you know, reduce the length of stay, to prevent prevent the hospitalization in the first place. So they'll have ability to use it everywhere and anywhere they want right away. Unlike, you know, in the rest of the world where, you know, you have to write a prescription, you have to do a prior auth. These guys, they own everything. So if they want to discharge early to finish the job at home, they're going to be able to do that.
spk08: I think that's one thing, Doug, that we've heard a little bit more than we maybe initially anticipated. for doctors wanting to use this kind of post-discharge when a patient is getting ready to get out, actually writing a prescription. And I think with the IDNs, you'd even see more of that.
spk02: Okay, great. That's a really helpful call-up. Thanks, Doug.
spk03: The next question comes from Naz Rahman with Maxim Group. Please go ahead.
spk05: Hey, everyone, and congrats on the quarter, and thanks for taking my question. Just two quick questions. The first one I have is your number of unique prescribers seems to be increasing at a faster rate than the number of prescriptions between 2Q and 3Q. Can you comment on what that discrepancy is?
spk08: Yes. So, again, what, you know, we've still been focusing on, especially some of the new territories, is opening new accounts. And, you know, again, these in-services take some time. And then converting those first scripts. So a lot of the new prescribers might be just writing one here early, see how it works, you know, wait for the patient to come back before adopting it. So I think that's what you're seeing. But we have a number of physicians. And how it usually works, Naz, is there might be you know, three or four doctors and three or four nurse practitioners, or maybe just one nurse practitioner for four doctors. And the nurse practitioner ends up being the writer, even though the doctor might have written one, the nurse practitioner tends to do most of the diuretic doctoring. So I think we like where we're seeing the breadth because we're starting, especially, you know, on the start of this quarter, we've really seen a lot of the physicians now starting to write more consistently. October was a really strong month for us, and November is off to a really good start. So I think we're being successful in converting those doctors who have wrote one or two into doctors or their nurse practitioners really starting to adopt the product.
spk05: Thanks. That was helpful. And my second and last question is, on the IDN network, could you provide some color commentary on, I guess, like, how many offices or facilities this represents beyond the number of patients? And, like, how long would it take you to do in-services, or how many in-services do you have to do in this network to gain traction?
spk08: Yeah, so the network we announced today, you know, it's kind of a hybrid IDN where There's hospitals, some of them with pretty big heart failure clinics, and they've also got a network of kind of individual physicians that a lot of them practice inside the facility, but some of them are private practice seeing patients there. Steve, I don't know if you want to add anything to that.
spk09: The beauty of an IDN is they can control the training. They can schedule the employees to be available, and they'll do a lot of that in-servicing themselves. We won't necessarily have to do it one location at a time. In fact, they talk about they like to control it. They like to do it their way. They like to follow up, and so that's not a burden for us.
spk02: Got it. That was helpful. Thanks for taking my questions. Thanks.
spk03: Once again, if you have a question, please press star, then one. The next question comes from Chase Knickerbocker with Craig Halem Capital Group. Please go ahead.
spk07: Good afternoon, guys. Thanks for taking the question. Maybe just first for me, let's kind of look within that, you know, Rx written, Rx filled maybe with the physicians who are having the most success, where they're writing the most, where you're starting to see kind of a percentage inversion of those written scripts being a little bit higher. Do we see any sort of, you know, kind of similarities between some of those places where you've contracted, where there's a higher percentage of those patients who are on that fixed-year co-pay, and then maybe talk about how, you know, different fire-offs kind of protocols or maybe driving higher or lower converting there as well. Thanks. Thanks.
spk09: So, if I'm hearing correctly, the prescribers or the offices that have a higher percent filled versus others that are lower, above the average of 55, the more they use the product, the more they get comfortable with the process of doing it, providing the proper prior authorization information. the smoother it goes. The more experience they have, they also now start to look for patients who have, you know, better access to the product. We're seeing, you know, docs who are selecting more Medicaid and more commercial and Medicare Advantage patients. And so for them, now that they believe in the product, they've seen the results, you know, they can select. And they're offering it to folks where it's a little easier, who may not necessarily have a, you know, a high copay. So we're seeing some of that.
spk08: Yeah, and I think You know, Chase, I think what we saw and what we're continuing to see is that offices are getting more used to filling out the start form and whatever information they need. Plus, our specialty pharmacy is doing a better job at finding patients. You know, some of these patients, when they get a phone call, they don't recognize the number, they don't pick up. So we're texting, we're sending them letters. So I think all of that, and I think we've talked about that, that this is part of the process of raising the fill rates. The other part of the process, obviously, is getting co-pays down on adjudication time faster, which is what we're working on the market access side of it. But I do think what drove it, the increase in Q3 for doctor's offices and especially pharmacy, really finding the best ways to engage with these patients. And we've done market research about that, about how best to engage with these patients. So I think that's going to continue into this quarter and into next year. And I think when we put on top of that managed care, you know, payer wins, which can increase or decrease adjudication time and lower co-pays, it'll all drive that fill rate up.
spk07: Maybe digging in there just a little bit. What are you seeing from an adjudication kind of timeframe on the ones that do eventually get filled? Is that, you know, time frame tightening? Just any sort of additional color there would be helpful. Sure. Steve?
spk09: Yes. So, it's doctor and patient kind of dependent. It depends on what they want. If they're looking for expedited treatment, like they want to get on treatment tomorrow or the next day, we do that very well. 24 hours to 48 hours, the docs have checked the expedited review on the start form. So that's working very well. What people need to remember is we have docs who order the product in advance of needing it. They submit the form, they get an approval for the product, they have a known copay, and then they have it ready in a queue until they want to pull it down or release it to the patient. And so, when you're doing that, you have quite a variability in the fill rate, but it's by design. It's on purpose. So, I'll just answer the ones who want it quickly are getting it quickly.
spk07: And maybe, do you guys kind of have visibility on how, what percentage of these, you know, filled and written scripts are, you know, get a Spirosex now versus, you know, kind of writing and waiting? for when, you know, these patients need it? Any sort of kind of split there that you can share?
spk09: Yeah, it's, I don't have the actual numbers. That's a good thing. I'll have that for next time there's a question. Looking at the reports every day, it's like 50-50. About 50% of people are seeking it, you know, as quickly as possible, and they're getting treatment. And then about 50% of them are just sending it in, getting answers, and they're ready for when the patient needs it.
spk08: And, you know, we think that's going to really play out, you know, especially this quarter as we get into the holidays and patients tend to be Dietary non-compliant, medicine non-compliant. We hear from all the doctors, hey, we're going to queue this up. I know Mrs. Jones is going to get in trouble. Thanksgiving, she always does. So we're really seeing a lot of that this quarter and think they'll be able to pull them through this quarter as well.
spk07: I understand people more than you guys, but of those 400 that are still pending, is it fair for us to think that all of those are kind of the right weight that we could still see come through?
spk09: I would say if you do the math calculation on what we published, there's about 16% of all the prescriptions that were canceled. The other 442 are, a lot of them have been cued, and the bunch of them that were still pending, not cued, have been shipped in Q3. I'm sorry, Q4. As Q4 has evolved, we've shipped a lot of the pending ones.
spk02: Helpful. Thanks, guys. Thank you, Chase.
spk03: This concludes the question and answer session. I would like to turn the conference back over to John Tucker for any closing remarks. Please go ahead.
spk08: Okay. That concludes our call this afternoon. We remain very pleased with the trajectory of our Ferosix launch and the meaningful progress that we are making with large payers, and that should only add to our momentum as more heart failure patients gain affordable access to furlough services. At the same time, we are excited about our lifecycle initiatives after having productive discussions with the FDA and look forward to providing more updates in 2024. Overall, I'm pleased with our progress and believe that we can build upon our current momentum and look forward to a successful 2024. Thank you again and have a good evening.
spk03: This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.
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