Aquestive Therapeutics, Inc.

Q2 2022 Earnings Conference Call

8/2/2022

spk01: Good morning and welcome to the Equestria Therapeutics second quarter 2022 conference call. At this time, all participants are on a listen-only mode. After this week's presentation, there will be a Q&A session. To ask a question during this session, you will need to press star 1-1. As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Bennett Watson of ICR Westlake Investor Relations. You may begin.
spk10: Thank you, operator. Good morning and welcome to today's call.
spk13: On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of recent business developments and performance for second quarter 2022, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Steve Wargacki, Vice President of R&D, and Ken Marshall, Chief Commercial Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call will be made available on Equestive's website within the Investors section shortly following the conclusion of this call. To remind you, the Equestive team will be discussing some non-GAAP financial measures this morning as part of its review of second quarter 2022 results. A description of these measures along with the reconciliation to GAAP can be found in the earnings release issued yesterday, which is posted on the investor's section of Equestria's website. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factors section and other sections included in our annual report on Form 10-K filed with the Securities Exchange Commission on March 8, 2022, and in our quarterly reports on Form 10-Q and current reports on Form 8-K filed with the FDC. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations. The impact of the ongoing COVID-19 pandemic is highly uncertain and cannot be predicted with certainty or clarity. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to Equestiv or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statement after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. With that, I will now turn the line over to Dan.
spk06: Thank you, Ben. In many ways, this last quarter was the most challenging in the company's history. We managed through not only a CEO transition, but a significant change in market value from the beginning to the end of the quarter. At the same time, macroeconomic conditions around us continued to deteriorate driven by inflation, recession concerns, and global events. These circumstances have led us to reassess our key priorities and how we are creating value for our various stakeholders, including patients and investors. When I think about how we can help patients, I am more optimistic than I have ever been in my 15 years with the company. We have not one, but two acute rescue medications under development that have the potential to transform the patient experience within their respective therapeutic areas. These two medications are AQSP-109 epinephrine sublingual film for the potential treatment of severe allergic reactions, including anaphylaxis, and Libervin diapam-buccal film for the potential treatment of seizure clusters. This is a great physician to be in. When I think about the investment community, clearly have work to do. The quest of story has been overshadowed by a variety of factors, including low proprietary product sales, driven by delays in the FDA review of Liberman, and our cash burn rate. Over the next several months, I will be focused on reinvigorating the quest of story and ensuring that the true value of our two major pipeline products is understood by all of our stakeholders. One of the most exciting elements of the Equesta story is the fact that, if approved and launched, both acute rescue medications have patents that extend well into the late 2030s. We must not forget the significant opportunity to create long-term value associated with these two product candidates while we manage the company's near-term changes. Let's talk about two items that we have direct control over.
spk14: proprietary product sales, and our cash burn rate.
spk06: While I will leave it to Ernie Toth, our CFO, to provide more specificity, I can tell you that we are committed to eliminating the cash burn associated with the commercial support of Sympathetic Oral Film to the treatment of seizures associated with the Lenox-Gibson Syndrome, or LGS. This part of our business must be profitable on a go-forward basis. we have eliminated almost all of the commercial burn through continued growth and right-sizing our non-sales infrastructure. As painful as this has been, right-sizing our organization was an important step forward. This means that our cash burn will be limited to our important product development efforts on AQSD 109, supported by our corporate functions. We have a variety of levers that we can use to manage our cash burn. These include our ongoing US and ex-US licensing activities, continued reductions in expenses, working with our lenders on a potential refinance of our debt, and conducting a basic strategic review of our assets. It is important that we view each asset of the business objectively and in the context of the broader business. From my perspective, I continue to believe that investing in AQST 109 is a great opportunity for Requested and the right place to focus our resources, time, energy, and cash. According to experts, over 40 million Americans are at risk of experiencing a severe allergic reaction, including anaphylaxis. Yet each year, only 3 million prescriptions are filled for injectable epinephrine. We believe this is a major gap that needs to be addressed through patient education, improved risk management, and yes, additional product options. For the three million or so Americans who do fill a prescription, it is far from certain as to whether they will carry their autoinjectors with them. I believe introducing a product that is simple, can be carried in a pocket, and delivers target levels of epinephrine quickly would be a welcome addition for patients caregivers, and healthcare providers. In fact, in a survey of over 500 allergists, pediatricians, and primary care physicians, we found that 88% of survey respondents were concerned about patients and or their caregivers consistently having their auto-injectors on hand at all times. Our survey data also suggests that too often patients and caregivers use off-label drugs, such as antihistamines as their first-line treatment for severe allergic reactions. We found that 83% of survey respondents agreed that patients with at least some risk for anaphylaxis too often administer oral antihistamines in place of an epinephrine autoinjector. And unfortunately, many allergists will tell you drugs such as antihistamines do not stop the allergic cascade that marks the beginning anaphylaxis. We are also excited by the consistently fast time to maximum concentration, or Tmax, we have seen in studies to date. As far as we are aware, no other alternatives to injected epinephrine has achieved a Tmax that is comparable to EpiPen, the standard of care. These are just a couple of the reasons that we feel so strongly about AQST-109. compelling data for the use of sublingual epinephrine as an acute rescue medication. We are currently in the clinic with our EpiFast 2 study and will have direct comparative data to EpiPen before the end of the quarter. As we've previously guided, we expect to meet with the FDA in Q4 to conduct an end-of-Phase 2 meeting for this program. Now let's talk about liver men. All of us especially our patient stakeholders, have waited far too long for this product to come to market. Sometimes, because of delays like the one we are experiencing, our stakeholders can forget why this drug is so important to the patient population. Imagine being a patient with at-risk procedure clusters. Every part of your daily life must be viewed through the lens of a potential seizure. Where will you be when it happens? Will you have your medication with you? Will you be able to use your medication? Will those around you be able to correctly administer your medication? Will it work after a single administration and under all conditions? And will you have to worry that more seizures might occur within hours of your first dosing? Liverman was built to fit the lives and activities of the patient. As one caregiver of an LGS patient, currently uses Simpazin recently wrote to the FDA, the fact that Simpazin is so easy to administer and that it dissolves quickly gives us the peace of mind that the medication is most effective. We are also able to carry Simpazin effortlessly because of its portability. My husband and I always carry an extra dose in our wallets. Based on our experience with Simpazin, we are writing to advocate for the approval of Liberman It would be a huge contribution to the epilepsy community to have a rescue medicine with the affordability, ease of use, and precision that we have experienced with Simpson, end quote. From my perspective, the most credible voices come from those who have had to live with and manage the potential onset of seizure clusters. We believe our final label for Liberman and our publishable clinical results will provide patients with many compelling answers to the questions I mentioned before. We are anxious to bring this offering to the patient population and we will continue to work with the FDA to reach a final decision on our application. While we can appreciate that the FDA has faced unprecedented challenges over the last several years between the pandemic and continuous orphan drug litigation, we remain disappointed the FDA did not meet its commitment on our PDUCA date. Despite the challenges that Libervin has faced, each day that goes by brings us closer to both an FDA decision and the expiration of any exclusivity hurdles facing Libervin. From my perspective, the patient need for additional medical options in this space remains great. And if approved, we will be focused on getting patients access to Libervin rapidly as possible. It would be unrealistic to think that we can solve all of the problems facing Equesta immediately. However, we are laser focused on continuing to carefully manage the elements of the business we control while rapidly progressing our pipeline programs towards significant value inflection milestones. We can also make sure that the Equesta story is one that is clear and transparent and unobscured by unnecessary noise. Sometimes the simplest stories can be the most compelling. In my view, a pharmaceutical company with the existing revenue and two acute rescue medications under development that both have strong clinical results to date as well as long patent lives is a simple and compelling story. In summary, we anticipate that our revenue generating divisions profitable going forward. We have reduced our expenses and are carefully managing our cash flow through our available levers. We have two exciting acute rescue medications under development, both with potential to transform the patient experience. We are focused on reinforcing the inquestive story with our various stakeholders while we execute on our strategy. With that, I will ask Ernie to walk you through the most recent financial results.
spk14: Thank you, Dan, and good morning everyone. By now you have seen our financial results in our 10Q and earnings release that were filed last evening. As we typically do, we will address most of the discussion related to the second quarter 2022 results in the Q&A. During the second quarter, we continued to manage the company for success as we raised additional capital and reduced expenses going forward to extend our cash runway. On June 8th, we closed on a registered direct offering with a single healthcare-focused institutional investor and certain of the company's executives, generating net proceeds of approximately $7.8 million after deducting fees and expenses. We intend to use these net proceeds from the offering for general corporate purposes. On April 12th, we entered into a purchase agreement with Lincoln Park Capital Fund, which provides that upon the terms and subject to the conditions and limitations under the purchase agreement, the company has the right, but not the obligation, to sell to Lincoln Park up to $40 million of its common stock from time to time over the 36-month term of the purchase agreement. The Lincoln Park facility, along with our existing ATM facility, should we decide to utilize them, are available tools for requested. However, we will always look first at options that are non-dilutive and available to us to extend our cash runway. During the second quarter, we implemented expense reductions to reduce the cash burn of our commercial operations and right-size the companies. while preserving the continued development of AQST 109. These expense reductions contributed to our improved 2022 EBITDA guidance, which I will discuss later. Our strong ongoing commercial and manufacturing supply businesses are already implementing expense management and business development activities, as well as the additional funds available under our existing debt facility should liverband be approved and gain market access, provide the tools and flexibility as we fund our ongoing business activities. Total revenues were $13.3 million in the second quarter of 2022, compared to $15.3 million in the second quarter of 2021. Excluding a one-time milestone earned from PEMFARM of $2 million that was recognized in the second quarter of 2021, total revenue remained flat. Total revenues were $25.5 million for the six months ended June 30th, 2022, compared to $26.5 million for the six months ended June 30th, 2021, excluding the chem farm milestone of $2 million, as well as the deferred revenue of $2.1 million from the terminated license and supply agreement with Fortovia Therapeutics that was recognized in the first quarter of 2021 but did not reoccur in 2022, total revenue increased by $3.2 million, or 14%. This increase was primarily driven by increases in proprietary product sales of 29%, as well as manufacturer and supply revenue of 11%. Our net loss for the second quarter of 2022 was $16.3 million, or $0.36 loss per share. The net loss for the second quarter of 2021 was $12.4 million, or $0.33 loss per share. The year of change in net loss was driven by lower revenue, as mentioned earlier, and higher costs and expenses, including severance costs of $2.3 million in the second quarter of 2022. This was offset by a decrease in interest expense and a decrease in non-cash interest expense related to the ConMobi monetization transaction. Our net loss for the six months ended June 30th, 2022 was $29.5 million or 68 cents loss per share. The net loss for the six months ended June 30th, 2021 was $27 million or 74 cents loss this year. Non-GAAP adjusted EBITDA loss was $9.9 million for the second quarter of 2022 compared to a loss of $4.1 million in the second quarter of 2021. The year-over-year change in adjusted EBITDA was driven by higher net loss, including severance costs. Non-GAAP adjusted EBITDA loss was $18 million for the six months ended June 30, 2022, compared to a loss of $10.3 million for the six months ended June 30, 2021. Cash and cash equivalents were $17.7 million as of June 30, 2022. As outlined in the press release issued last night after market close, we are revising our full year 2022 financial outlook Our updated financial year expectations are total revenues of approximately $46 million to $49 million, increased from $42 million to $47 million in prior guidance, non-GAAP adjusted gross margin of approximately 70% to 75%, and non-GAAP adjusted EBITDA loss of approximately $37 million to $43 million, improved from $51 million to $58 million in prior guidance. It is worth reiterating that this 2022 financial guidance does not include any revenues from Liberman and will not until we receive FDA approval of Liberman for the U.S. market access and the launch is underway. In summary, our 2022 guidance for full-year non-GAAP-adjusted EBITDA loss reflects continued strong performance by both our commercial operations and manufacturing and supply operations, and continued focused R&D investments related to the advancement of AQST 109. At the same time, our implemented expense management across our business will allow us to be as capital efficient as possible. With that, I will now turn the line back to the operator open the line for questions.
spk01: Thank you. And as a reminder, ladies and gentlemen, if you'd like to ask a question, you will need to press star 1-1. Please stand by while we compile the Q&A roster. Now, first question coming from the line of Gary Nachman with BMO Securities. The line is open.
spk03: Hi, this is Evan Hua. I'm for Gary Nachman. Thanks for taking our questions. For liver event, is there any more visibility on that timeline? And if you can add any additional color regarding the discussions with the different groups at FDA, including the orphan drug group. And I have a few follow-ups after that. Thanks.
spk06: Sure. Good morning, Evan. Nice to hear your voice. So, look, we're all frustrated with the delay at the FDA and liver event. 2030s, we know the unmet need remains high. We're the only oral product that is under review at the FDA for this phase. And so from our perspective, while we're frustrated at an eight-month delay, we have to remember the tremendous potential value associated with this program as we go through the years to come. When it comes to the FDA, at this point we're having what I would describe as just about weekly interactions. My last interaction with the FDA was in the last two weeks, and it was with the head of the Orphan Drug Group. I can tell you they are acknowledging our patients. They've indicated that they are making progress, and they've reiterated that they will get a response in a reasonable timeframe. I do believe them. I do believe they're working up. I do believe they're making progress, and I do expect we will get an answer in the future. With that, I would ask what other questions we can answer for you today.
spk03: Great. And then for AQST109, what are you planning for in terms of the pivotal PK, especially with the final formulation size and dose? And secondly, would the study be sufficient for filing?
spk06: Yes. be clear, we're already using the final formulation and dose, the EpiFast study that we just completed. In all three parts of that study, we used the dose and the strength that we will be using in our Pivotal PK study. In terms of the design, I'll pass it over to my colleague, Steve, to give you a brief overview of that. Thank you, Dan. Yes, so we continue to prepare for the Pivotal study. However, we
spk11: We are approaching our end of phase two meeting in Q4 of this year, where we'll get, we think, full alignment with the FDA on all the critical statistical endpoints that we need to have a successful PIPL study.
spk06: Evan, was there a last part to your question, or did we cover your question?
spk03: Yeah, last part. Is the study going to be sufficient for filing, or would you need another study?
spk06: Yeah, well, as Steve mentioned, the end of Phase II meeting we do see as a critical milestone for this program, whereas you know in that meeting we'll lay out with the FDA our remaining work to filing and make sure that they are aligned with our view. Right now, the two studies that we are planning prior to filing would be the pivotal PK study that Steve just mentioned, as well as a small pediatric study in healthy volunteers. Other than that, who will do a human factor study that's already ongoing. We don't plan at this point on doing any additional studies prior to filing.
spk03: Great. Thanks for taking my questions.
spk01: Thank you. And our next question coming from the line of Jason Butler with JMP Securities. Your line is open.
spk11: Hi. Thanks for taking the questions. I just had a couple about the most recent data you announced from the FFS1 study. For the arm where you looked at the swallowing data, I guess, can you talk about the tolerability profile that you saw in that arm? And then just from the fact that you saw actually pretty meaningful absorption and good PK there. How are you thinking about, you know, using this information in the pivotal planning and what, if any, you know, regulatory implications it might have? Thanks. Yeah, good morning, Jason.
spk06: So, when we think about the epithet study, I think it's important to remember this was a six-month study, so a big body of work. There were three parts to it with multiple arms in each part. And as you talked about in this latest or last part, we included characterization work where we looked at the performance of our products when a subject doesn't follow the instructions for use appropriately, and also after having eaten something, in this case, a peanut butter sandwich. As you noted, we were surprised by the robustness under all conditions of our results. And we do believe that the profile And when I say profile, I mean the pharmacokinetic results as well as the PD results are all favorable to our application and what we'll put forward to the FDA. So we're very happy and pleased with what we saw in that characterization work. In terms of the tolerability profile, we have no serious AEs in our study. And when we look at the AE profile, it is aligned with the what's known with the EpiPen and other injectable products that are in the market.
spk10: Okay, great. Appreciate it. Thanks for taking the question.
spk08: Thank you. One moment for our next question.
spk01: Now, our next question coming from the line of Thomas Plant with Lake Street Capital. Your line is open.
spk02: Yeah, good morning. Thanks for taking the questions. I was wondering if you could provide some additional color on some of the rightsizing that you've done in the commercial organization, particularly with respect to field force.
spk06: Sure. Good morning, Thomas. So from a rightsizing perspective, we took action across the organization, so across functions. We did not just rightsize within the commercial group, but specifically on the commercial side, the focus was on the non-sales bearing part of the organization. So we have worked hard to maintain the footprint that we have. And as you see, we grew our snippets and scripts again this last quarter, and we continue to grow our scripts each quarter. I think it's critical with that important asset that we work towards being cash flow positive, and that is where the focus of that group will remain as we go forward.
spk02: And with respect to Libervan, when and if a decision comes from FDA, will there be any heads-up on your part? I know we don't have a BDUFA data out there, so you don't really have anything to aim for. I was thinking about, you know, fuel force expansion and how you're going to support that commercially. Will all of those decisions be made post-decision since you don't have a heads-up, or how are you thinking about that sequencing?
spk06: Right. So we will have to – we would expect there would be some back-and-forth. prior to receiving a decision, whether that's a matter of a couple of days or a week, it really depends on how they reach out to us. But in terms of launching Libervin, we remain ready to launch Libervin immediately upon approval. And I'll pass it over to my colleague, Ken, in a second. But what I would say is we are focused on launching Libervin within our means, is the way I would put it. you will not see us hire 40 reps the next day or bring on a large new portion of debt to the company. We will launch within the means that we have, and we think we can do that very efficiently. Ken, if you could just elaborate a little bit on the launch plans for Liberton.
spk12: Sure. Happy to, Dan. Good morning, Thomas. Probably the key step here is is stock in the trade that usually takes you about 30 days. So there would be a little bit of room in that period to train and maybe expand targets for our current footprint. The current footprint that Dan alluded to covers nearly two-thirds of the rescue opportunity. As you imagine, it's pretty concentrated. And Simpadan's put us in the right place to get to know these folks. And so I think we're set for a very rapid launch, even if we didn't get much notice from the FDA.
spk02: Got it. And then just one final one for me. As part of these cost-cutting measures, and I know we haven't talked about anything else in the pipeline beside 109, is it fair to assume that most other things that you might have had in the pipeline are on hold at this point until LiberVent and 109 make some forward progress?
spk06: I think on hold might be too strong a phrase. AQFP 108 in particular, we do continue to see a place in our pipeline for that program and we remain excited about the profile that Steve and his team have created with that product. I would describe the work that we're doing on that as CMC-focused work at this point. So I don't want to say it's on hold. What I would say is we will concentrate our resources, as I said earlier in this call, on 109 to make sure that we
spk02: Great. Appreciate you guys taking the questions. Thank you.
spk01: Thank you. One moment for our next question. And our next question coming from the line of Andreas from Whitworth. Your line is open.
spk04: Good morning. Thanks for taking our question. Could you just elaborate a little bit more on the plans for non-dilutive cash to extend the cash runway? And then thinking about Libervant, how are these kind of larger political dynamics at play? You know, the Catalyst Farm Decision Fairness and North and Drug Acts, et cetera. How are these impacting the OPD decision on ODD for Libervant? Thanks.
spk06: Sure. Good morning, Andrea. From a non-dilutive cash perspective, as Ernie laid out in his comments, We do have multiple levers that we're very focused on right now. One is expense management, and you heard us talk about the right-sizing we did, and we'll continue to make sure that we are very focused on maintaining a lean expense structure. We also, we do have a variety of levers when it comes to the assets we have in our company, so out-licensing, Some of the assets we have, whether it be ex-U.S. or even within the U.S., is something that we will continue to look at. The final piece, which does also tie to expenses but also ties to the top line, is focusing on profitability. We have two parts of our business that are cash generating with our commercial sales and our manufacturing sales. In both places, we will continue to make sure that we operate as efficiently as possible to maximize cash that comes out of those components. I think the second part of your question, Andreas, was on the political environment, and I think you were referring to the RARE Act and the Padipa reauthorization bill going through Congress. We, like everyone, are watching that carefully. There's implications for the entire industry on when and how that bill gets passed. I would say it's a little early to tell If the FDA will be impacted by that reauthorization bill, we're hopeful, like everyone else in this industry, that Calus doesn't have to do any layoffs within his organization. In terms of orphan drug specifically, we do believe the FDA is wisely trying to fix some of the problems that have occurred in the orphan drug space, and we're supportive of what
spk09: that the legislation meets their needs. Great. Thank you.
spk08: Thank you. One more for our next question.
spk01: And our next question coming from the line-up, Ram Subbaraju with HC Windward. Your line is open.
spk05: Thanks so much for taking my questions. Firstly, with respect to Simpazan, can you talk a little bit about how growth to nets have been evolving lately and where you expect that direction to go over the course of the coming months and quarters?
spk06: Sure. Good morning, Ram, and I'll hand it over to Ken on that. I just want to reiterate that we continue to grow every quarter, and this asset is valuable to the organization, and we want to make sure it continues continues to expand and that patients continue to have access to it. Ken, could you walk through your growth strategy a little bit?
spk12: And, Ron, was the question growth strategy or gross to net? I'm sorry. It broke up a little bit. Oh, gross to net. Gross to net. I thought it was gross to net. Yeah. I'll give you some high-level information, and then, Ernie, if you want to be more specific, jump in. I mean, when you look at our gross to net, it's fairly predictable. If you look at our history and then anticipate some level of price increase, about half of our business is Medicaid, Medicare. And so you're going to give some of that back with the CPI penalty. Now, having said that, with inflation, we'll probably get a little bit of a break. So generally, you might expect a point or two gain year over year would be not a bad estimate.
spk10: Okay, that's helpful.
spk05: Secondly, I wanted to ask about 109 relative to 108 and how you folks are thinking about this from a strategic as well as a clinical development perspective. Should we look at 109 and 108 as being directly complementary, things that can be commercialized using exactly the same infrastructure, or how distinct are they really? And from a business development perspective, as you look to optimize the value of these assets, are you looking at treating them as a package deal? Or would you look to potentially, for example, execute something from a business development perspective on 108 independent of 109? Thanks.
spk06: Right. So, Ram, I'll actually start backwards in your three questions, if that's okay. From a BD perspective or business development perspective, I think that's a little early. We're right now very focused on creating value with 109 and not on out-licensing it or putting it in someone else's hands. So I don't think you'll see us do anything on that front. In terms of infrastructure, I think it's very plausible that 109 and 108 are complementary to each other. We view our epinephrine pro-drug work as a platform, and that platform, while it can be
spk10: useful outside of the allergy space has multiple applications that can be in the allergy space. I think it's well within our strategic thoughts to see them as aligned with each other.
spk06: In terms of how to compare the two against each other, we do see them as, while they are complementary, they would be targeting very different indications. So, 109 clearly will be an anaphylaxis product. 108, I know we haven't clearly talked about all of the indications, but would be in different areas within the allergy therapeutic area.
spk10: Thank you.
spk01: Thank you. And as a reminder, ladies and gentlemen, if you'd like to ask a question, you will need to press star one, one. One moment for our next question. Our next question coming from the lineup, James Malone with Alliance Global. Your line is open.
spk07: Hi, good morning. Thank you for taking my questions. I have a quick question on the, on the Salesforce. Can you walk a little bit through the Salesforce size, sort of the, I know you've mentioned on the right-sizing, you try to avoid the front-facing sales force. Can you walk a little bit through some of the most effective channels you're finding currently? And how's the overlap between the current sales, the Simplizan versus the 109, if it were to come into market? Would it be going through the same guys? Do you need a new group of folks?
spk06: Sure. Thanks, James. And, Ken, could you walk through that for James?
spk12: Yeah, happy to, James. Our current footprint consists of 16 territories and a layer of first-line management above that. In the CNS space, especially with Simpazan as an adjunctive medicine, it's a very efficient call point. When people get on a second and a third medicine, they're certainly being seen by an epileptologist or an epilepsy specialist, and you would count those in the numbers of thousands. So a 16-territory footprint is not a bad size If you look at Libervant, there'll be slightly more physicians that use that rescue medicine, so you'll probably expand it slightly. But as I mentioned earlier, that 16 territory footprint covers two-thirds plus of the rescue opportunity. Are there other pieces that you'd like me to comment on, or does that answer your question?
spk07: I think that should answer it. I guess, I mean, the impact of the right sizing, you know, what sort of, what sort of did you cut away? And any thoughts, any add-backs again? Should LiberVent come, you know, get approval or, you know, 109 down the road?
spk12: Yeah, the cutbacks in the commercial ops, as Dan mentioned, were really the back office folks. We focused on preserving the customer-facing team and those, and maintaining those relationships. you probably would want to go a little deeper than two-thirds of the target volume out there. But as you would imagine, it's like most markets, it's concentrated. So you don't have to go from 16 to 80 to materially penetrate the rest of this market. You could add single-digit, maybe low double-digit representatives and get closer to that 80, 85% coverage. And then it's just all a matter of how far down the deciles we want to chase. in terms of volume when you go past that.
spk07: Last question. You mentioned potentially out-licensing or partnering products. How would you characterize the current environment for that? Is it a seller's market, a buyer's market? What's the level of interest that you could be able to characterize for outsiders like us looking in?
spk06: Sure, James. First, I would just say at a global level, With the CEO transition, it's normal to obviously take a look at everything, the pieces and parts and priorities and how we think about those things. So that work is still going on in its early days. So I don't think we have a specific view on what exactly the pieces and parts would be that we're working on right now. But what I would give you is, my interactions with how the market is in terms of licensing opportunities. I think it's still robust. I think obviously in Q1 and early Q2 with how the markets performed, people seem to be nervous, but the environment that I see right now and we're experiencing is much more positive.
spk07: Excellent. Thank you for taking the questions.
spk01: I'm showing up for the questions at this time. I would now like to turn the call back over to Dan Barber for any closing remarks.
spk06: Thank you, Lydia. Thank you for everyone for joining today's conference call. I would just leave you with a reminder of where our focus will be. We are focused on progressing 109 rapidly. We're focused on interacting with the FDA to ensure we get Liberman to the market as soon as possible. At the same time, we will continue to be very diligent on our cash management making sure we tell the requested story to you and our other stakeholders as clear and transparent as we can. We will now conclude today's call.
spk01: Ladies and gentlemen, that's our conference for today. Thank you for your participation. You may now disconnect.
Disclaimer

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