NASDAQ:EVOK Evoke Pharma Q4 2023 Earnings Report $2.15 0.00 (0.00%) As of 04/17/2025 04:00 PM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings History Evoke Pharma EPS ResultsActual EPS-$7.08Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AEvoke Pharma Revenue ResultsActual Revenue$1.68 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AEvoke Pharma Announcement DetailsQuarterQ4 2023Date3/14/2024TimeN/AConference Call DateThursday, March 14, 2024Conference Call Time4:30PM ETUpcoming EarningsEvoke Pharma's Q1 2025 earnings is scheduled for Monday, May 12, 2025, with a conference call scheduled on Tuesday, May 13, 2025 at 4:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Evoke Pharma Q4 2023 Earnings Call TranscriptProvided by QuartrMarch 14, 2024 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Evoqu Pharma 4th Quarter and Full Year 2023 Earnings Conference Call. Currently, all callers have been placed in a listen only mode. And following management's prepared remarks, the call will be opened up for questions. Please be advised that today's call is being recorded. I'll now turn the call over to Daniel Canto of Boeing. Operator00:00:35Please go ahead, sir. Speaker 100:00:37Good afternoon and thank you for participating in Evolq Pharma's conference call and webcast today. With me today are Dave Gonyea, Evoke's Chief Executive Officer Chris Questenberry, Jamode's Chief Commercial Officer from Eversana and Matt Dionofio, Evoqu's President and Chief Operating Officer. By now, you should have a copy of the press release we issued earlier. If not, it is available on the Investor Relations page of our website at evokepharma.com. We encourage everyone to read today's press release as well as Evoque's Annual Report on Form 10 ks, which is now filed with the SEC. Speaker 100:01:16The company's Form 10 ks and earnings release are also available on Evoke's website. Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, management will be making forward looking statements. Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified by the cautionary statements contained in Eagle's press releases and SEC filings, including its annual report on Form 10 ks and subsequent filings. Speaker 100:02:00This conference call contains time sensitive information that is accurate only as of the date of this live broadcast. Evoque undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call and webcast. With that, I would now like to turn the call over to David Gonyea. Dave? Speaker 200:02:24Thank you, Daniel, and thanks everyone for joining the call this afternoon. As was described in today's press release, 2023 marked a milestone in Evoqua's journey, not just commercially, but also in fulfilling our core mission, which is ensuring Jumoti is within reach for every patient who needs it. Let me tell you why this core mission is so important. It's because it's about the patient and their experiences that can and will fuel the progress help us fuel the progress as an organization. A testament to our efforts comes from the countless positive stories we've been told from healthcare providers, patients and our own sales representatives who hear and tell us some amazing patient success stories on a daily basis. Speaker 200:03:10While gastroparesis impacts predominantly women, today I'd like to share just a brief, very inspiring story that was just shared to us this week about a 30 year old male who battles both type 1 diabetes and severe gastroparesis. This man who was in and out of the hospital just about every month because of his gastroparesis, shared with his health care provider that since starting on Jomotie, he hasn't had a single hospital visit, not one. And to his admission, it's been life changing for him. It's stories like these that will push payers, providers and advocates to fight for patients who suffer from this insidious disease so they can receive the best care possible. Now this is just one of many affirmations we have heard that continues to energize our commitment. Speaker 200:04:06Now while we're humbled to receive these stories of success, we also want to encourage providers to do more to diagnose and treat these patients with gastroparesis. But unfortunately, the norm for patients is to wait years before they're diagnosed and then often told there's not much they can do can be Speaker 300:04:24done for them. When Speaker 200:04:27treatment is prescribed, all too often payers are pushing the cost to the patient or outright denying coverage. Payers can do better and patients deserve better treatment. The compelling evidence for JIMOTI goes beyond anecdotes. The scientific groundwork, the publication of our Phase III clinical data and the peer reviewed and plenary presentations of our real world health resource utilization studies at leading gastroenterology congresses demonstrating a reduction in emergency room and hospital visits and the significant total healthcare cost savings compared to oral medical underscores the value of Jomotie versus the current gold standard. Our story is really simple and straightforward, and it's shaping up to be very compelling as well. Speaker 200:05:21PMOTI achieves rapid and direct absorption in the bloodstream. Jimodi provides documented symptomatic relief as early as 1 week and now Jimodi shows improved outcomes versus oral metoclopramide. The drug delivery through the nose avoids the problem of the disease, which is an inability to predictably deliver pills into the small intestine to be absorbed. Importantly, many patients previously on oral medical combined in the HRU study or the health resource utilization study who were switched to JIMOTI likely because they were not doing well experienced the same reduction in ER visits and hospitalizations while taking JIMOTI, confirming its place as a transformative medicine in gastroparesis treatment. Now let me switch gears a bit and turn to some highlights for 2023. Speaker 200:06:18I'm happy to report that we doubled our net revenue for Jomotie over the last year. The number of new prescriptions grew by a notable 86% and the total prescriptions dispensed increased by 101% year over year, clearly demonstrating the growing demand for Jomotic. We also augmented our prescriber base by 72% while amplifying the depth of their prescribing by 36%. Our commercial team's relentless focus propelled our targeting and outreach to healthcare providers, driving our financial achievements above our expectations. At important gastroenterology gatherings such as Digestive Disease Week and the American College of Gastroenterology Conferences, our data was selected by the respective governing boards for plenary presentations at both meetings. Speaker 200:07:14This is a testament to the strength and importance of the health resource utilization study we perform. This data highlighted Jomotie's role in significantly reducing ER visits and hospitalizations, outperforming oral menopoclopride and delivering care at a reduced price. This evidence not only resonated with GI professionals, but also underscores our commitment to patient care and economic efficiency for payers. Further in our strategic initiatives, we transitioned our pharmacy services to Aspen. The strategic alignment with Aspen's robust platform positions us to better meet our distribution needs, enhance patient access and streamline our services. Speaker 200:08:01And Chris will elaborate a little bit more on this in a moment. Looking back on a year of dynamic growth, our strategic investments have paid dividends. We've not only strengthened the belief in JIMOTI, but doubled the patient count on therapy. As we lean into 2024, we're aiming high with a projected net revenue of approximately $14,000,000 nearly tripling our 2023 performance. And with that, let me turn it over to Chris to talk about our current commercialization activities and plans moving forward for this year. Speaker 300:08:37Thanks, Dave. To confirm the uptake and acceptance that Dave just spoke about and revalidate last year's commercial strategy, we also took a look at providers consecutively prescribing JYMOVI after their initial script. This slide denotes that close to 30% of our cumulative prescribers, which total 1748 physicians, have prescribed JYMOVI 5 or more times. The writers that have written prescriptions continue to write more and more over time. From our standpoint, this is highly encouraging and a strong testament to the drug's efficacy and prescriber and user friendly profile. Speaker 300:09:15The unabated adding of new prescribers or so called breadth of prescribing in 2023, while simultaneously continuing to grow the depth of prescribing is difficult to do and is also an indication that there is still significant potential for growth for JYANOVI. We have not reached any ceiling of use for JYANOVI. Quite the opposite is true. While not shown on the slide, our market share of metoclopramide of the medical market shows similar gains throughout 2023. Encouragingly, as you look across important prescriber audiences, the share of JYMOTI compared to oral metoclopramide grew throughout 2023 and is progressively stronger as you move from all potential prescribers of JYMOTI to those that are in our call time target list and further improves as you look specifically at call time targeted gastroenterologists. Speaker 300:10:11Importantly, our highest share for JAMOTI is with nurse practitioners and physician assistants who provide a significant portion of the medical care for patients with gastroparesis as many gastroenterologists spend less time in clinic just deciding instead to perform procedures or scopes. As mentioned, our objective is to nearly triple our performance in 2023 or excuse me, in 2024. In 2023, we built a solid foundation and believe we have earned the right to challenge our provider and payer colleagues to offer JAMOTI to a broader base of patients within diastatic Throughout 2024 and beyond, our focus remains steadfast, reinforced the belief in JYMOTI amongst providers. Importantly, we will make clear that oral metoclopamine did not have the same healthcare resource utilization reductions that Jomodi provided and underscore that the nasal route of administration matters. For appropriate patients, we will ask providers to switch to Jumoti, thereby broadening and deepening prescribing. Speaker 300:11:18We have addressed improving the fill rate for JYMOTI and we'll continue this imperative throughout 2024. We earned a significant amount of prescribing of Jomotie in 2023 and much of it was unable to be filled because providers sent the prescription to a local retail pharmacy. We will use tools and partners to mitigate this and guide scripts to a pharmacy in our network to capture scripts appropriately. Lastly, we will increase our communication and education for target dyskinesia and leverage latent concerns to clarify risks and encourage appropriate benefit risk discussions. Here again, there is tremendous untapped potential to clarify appropriate use. Speaker 300:12:00We will be clear about who is inappropriate for Jomotene and request those who are appropriate to be offered Jumoni. Practically, here's how we plan to build on these initiatives. We will continue to promote and advocate for Jomotae as the optimal choice for gastroparesis treatment due to its optimized nasal administration. We will support this with our quantitative and qualitative healthcare utilization data. And currently, we are partnering with pharmacy organizations to leverage their systems and services to mitigate prescriptions that fall outside our distribution lines and never reach patients. Speaker 300:12:40Additionally, with Aspen Pharmacy joining our network, we will gain access to their extensive pharmacy distribution network, including specialty drug pharmacies, improving genomic fill rates and ensuring our patients receive the treatment they need without delay. Through appropriate channels, we'll also persist to demystify the risks associated with heart of dyskinesia or TD through education and transparency. For background, part of dyskinesia is a side effect of select medications more commonly seen with older antipsychotic medication that causes involuntary movements to one's face and body that can't be controlled. The recent ACG guidelines indicate the risk of this side effect due to exposure to metoclopramide is lower than previously thought. In fact, it's likely less than 1%. Speaker 300:13:30And our own claims analysis presented at PDW in 2022 confirmed ACG's conclusion. By presenting clear data, including the low incidence and which at risk patients to avoid, we are shifting the narrative from fear to informed prescribing and monitoring. We believe this will reset perceptions and encourage physicians to prescribe JYPTIVONEI to appropriate patients with confidence backed by a comprehensive understanding of its safety profile. As we build demand and utilization of Jomotie, we've taken deliberate strides to enhance the accessibility of Jomotie by evolving our distribution and pharmacy capabilities. Our journey began with Evocassist or Empsona Pharmacy, which allowed us to implement the system swiftly, though it relied on manual processes and had longer fulfillment times. Speaker 300:14:22As we progressed to VidaCare, we significantly upgraded our capabilities, integrating seamlessly with medical workflows, enabling electronic prescribing, facilitating automatic refills excuse me, automated refills to expedite the filling process. Now, with Ascendia, we've taken our distribution to the next level. Building on our previous advancements, Asymbia offers real time patient communication via text, complete end to end automation, including prior authorizations, and transparent prescription status through accessible portals to physicians and patients. This not only streamlines the prescription process for health care providers, but also ensures that patients receive their medication promptly. Most importantly, Ascendia's robust infrastructure and expansive pharmacy network position us to further scale our reach and positively impact patient outcomes. Speaker 300:15:17These strategic enhancements embody our commitment to optimizing Zimodia access and signify our unwavering dedication to patient care. Although we've only just initiated a partnership with Ascendia, also known as Aspen Pharmacies, in November of 2023, it's clear we've identified a critical lever for enhancing our flow rates. Through refined strategies and communication and process optimization within the Aspen platform, we've seen a tangible uptick in our conversion rates. Specifically, there's been a 2% overall increase in the number of new prescriptions filled. Even more impressive when we exclude in process prescriptions and improvement jumps to 22%. Speaker 300:16:01Moreover, we're seeing a significant shift towards greater efficiency with a 6% increase in sales that are reimbursed without the need for our patient affordability programs, a testament to streamline process and inherent value proposition of Jomotie. Additionally, Aspen's focus on and transparent patient communication is yielding results. With Aspen, there's been a 12% reduction in patient initiated abandonment of prescriptions, underscoring our commitment to ensuring that patients not only start to continue their treatment with JYMOTI as appropriate. These metrics are not just numbers. They represent real improvements in patient access and adherence, which are vital to our mission of providing JYMOTI to all who can benefit from it. Speaker 300:16:49These benefits will also fall to the bottom line. As we fortify our commitment to ensuring Jumoti reaches those in need, leveraging technology remains pivotal. By actively reminding healthcare professionals to write prescriptions directly to Ask them, pharmacies that point prescriptions within electronic medical records, we are addressing retail leakage effectively. Using this approach, we successfully made headway in intercepting scripts that initially intended to be prescribed to a retail pharmacy and successfully redirected over 1500 of them to our pharmacy, including Essent. We believe that strategic communication effort with prescribers, pharmacists and patients alike is critical to cementing Jomotie's presence in the market and improving patient outcomes. Speaker 300:17:41Based on this success, we have recently expanded our coverage and partnership with other EMR partners. Our messaging is now enabled in nearly half of all electronic health record systems and we have added new partners in Doctor. First and Connected Rx at the beginning of this month, ensuring that JYMOTI prescriptions pathway is even more clear and direct. Now last year, we unveiled 2 real world evidence studies that demonstrated the qualitative and quantitative value of Jomotie in addressing healthcare resource utilization of patients with diabetic gastroparesis. Image on the left hand side of the slide shows the inpatient hospitalizations were reduced by 68% in patients using Trimody compared to oral medical And it also shows emergency department visits were similarly reduced significantly by 60% in those taking JYMOTI versus oral medical fomile. Speaker 300:18:39The 257 patients taking JYMOTI experienced 34 fewer hospitalizations and 84 fewer ER visits over a 6 month period. That is a significant win for patients who can spend more time at home with their families who are doing simple things that we all take for granted. The reductions will also be a significant win for patients. Amazingly, looking to the right hand side of the slide, despite numerically larger prescription costs in the Jomotie arm, total healthcare costs, which is the sum of all medical costs and pharmacy costs in counters, were significantly lower, in fact, over $15,000 lower for patients taking JYMOTI than those taking generic oral metoclopramide over 6 month period of time. These data sets reinforce JYMOTI's clinical benefits and illustrates its profound potential economic impact. Speaker 300:19:38The substantial reductions in hospitalization and emergency department visits speaks volumes about its role in enhancing patient daily life and reducing the burden on our healthcare system. Moreover, the significant cost savings highlight Tsumovis' value proposition, marking it not only as a superior treatment option, but also financially responsible choice for healthcare providers and payers. I would argue that this is more than a win win. It's a new standard in the treatment of gastroparesis, setting a precedent for how we evaluate treatment, efficacy and cost effectiveness for patients with this debilitating disease and progressive disease. No other agent, in fact, no other modality used for gastroparesis has these types of breakthrough data demonstrating outcomes. Speaker 300:20:29And so we're going to test these data with payers. In fact, we're doing that right now with insurers, PBMs and IBMs alike through market research and asking them how these data might impact coverage decisions. We are in the midst of wrapping up this research, but what we are hearing from payers is that our healthcare resource utilization data has enough provocative elements to potentially impact the coverage decisions for Jomotie based on the same HRU data that I showed you on the previous slide. A significant portion of payers who are not currently covering Jomotie indicated the data presented would make them reconsider coverage decision, with 40% of them affirming outright and another 40% expressing willingness to reconsider with additional evidence of cost and savings. Additionally, of the payers who currently do provide coverage for JYMOTI, nearly half said they would further ease the process documentation requirements for obtaining JYMOTI. Speaker 300:21:26This preliminary feedback bolsters our conviction that providing robust evidence can shift perspectives. Payers are looking for more detailed analysis of cost saving drivers and peer review data to underpin credibility. We recognize this need for continuing evidence generation, focusing on key factors such as reduced hospitalization lengths, lower readmission rates and the overall reduction of the prescription burden. Additionally, the reduction of burden of illness, the avoidance of unnecessary medical procedures and assurance of safety are pivotal components that would enhance the value story of JYMOTI. Now one of the main reasons for hesitancy among providers to prescribe JYMOTI is the fact that JYMOTI carries a boxed warning for targeted dyskinesia similar to what oral MediClip might have in their TD is a movement disorder that causes involuntary immune to the face or body. Speaker 300:22:23Certainly, it can occur with mediclofimide, but TD is more commonly associated with antipsychotic medicines. We've come to appreciate that TD is a mystery for gastroenterologists. Who don't deal with it on a regular basis and there is a significant gap in their understanding of TD and how often it occurs. Their apprehension is leading many to avoid using imidaclofimide or reserve it for the more refractory patients. We need to shift this narrative from being afraid and avoiding to one of educated and monitor. Speaker 300:22:57We will leverage our label and the excellent information within it to help providers see that the box warning is a roadmap and the label information are at guardrails to help the provider avoid prospective patients at risk and thereby develop a clear understanding of the many appropriate patients who can benefit from JYMOTI. Speaker 400:23:19We will update HCPs with Speaker 300:23:21the most recent data and guidelines around the risk of TD with medical thromide, which again is likely less than 1%. We will educate on which patients to avoid and we will clarify that to date no TB has been reported in the clinical development program or since the launch of Jomodi in October of 2020. We will intensify our education efforts moving forward to ensure that providers can make informed benefit risk assessments when considering Jomotie for their patients. Our multi pronged approach includes educating our sales team with the latest insights on heart of dyskinesia, empowering motility specialists through symposia providing and providing our sales force with targeted resources. And lastly, engaging patients through their providers with education so they can make informed choices. Speaker 300:24:09We continue to engage KOLs within gastroenterology, but importantly have expanded to educate and inform ourselves with KOLs within psychiatry and neurology specialties like Peter McAllister of the New England Institute of Neurology and Headache. And this is to inform our own education efforts. Our commitment is to ensure that every stakeholder from healthcare providers to patients is fully informed about XERMOTI, thereby supporting its appropriate use and reinforcing our dedication to patient safety and well-being. With that, I'll turn the call over to Matt to review the financials and closing remarks. Speaker 500:24:49Thanks, Chris. Once again, thanks again for everyone joining today. I'll get right into Evoque's financials for the Q4 and full year end 2023 results. As Dave mentioned, for the Q4, net product sales were approximately $1,700,000 compared with $796,000 during the Q4 of 2022 and a net loss was approximately $2,000,000 or $0.59 per share compared with $1,800,000 or $0.54 per share for the Q4 of 2022. For the year ended December 31, 2023, net product sales were approximately $5,200,000 compared with approximately $2,500,000 for the year ended December 31, 2022 and the net loss was approximately $7,800,000 or $2.33 per share compared with a net loss of $8,200,000 or $2.62 per share for the year ended December 31, 2022. Speaker 500:25:41The year over year increase in revenue was due to higher net product sales in 2023 resulting from prescription sales through pharmacy service partnerships with Pharmacy, as Dave and Chris elaborated earlier, and capture of prescriptions sent to retail pharmacies that previously didn't have the ability to order product and sharing with providers and the GI community the exceptional head to head real world data comparing Jomotie to oral metoclopimide showing improvements in fewer hospitalizations and ER visits with Qimodie compared to oral. Research and development expenses totaled $23,000 for the Q4 of 2022 compared to $27,000 for the 4th quarter of 2023. For the full year 2022, research and development expenses were approximately $200,000 compared with approximately 0 point $3,000,000 for the prior year. For the Q4 of 2023, selling, general and administrative expenses were approximately $3,500,000 compared with $2,300,000 for the Q4 of 2022. For the year ended December 31, 2023 selling, general and administrative expenses were approximately $12,200,000 versus approximately $9,600,000 for the year ended December 31, 2020 2. Speaker 400:26:53The increase in SG and Speaker 500:26:54A costs year over year resulted primarily from higher marketing, royalty and Eversound profit sharing costs. We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of Genuity and we reimburse Eversana from the net profits attained from the sales of Genuity. Total operating expenses for the Q4 of 2023 were approximately $3,600,000 compared with $2,300,000 for the same period of 2022. And for the year ended December 31, 2023, total operating expenses were approximately $12,600,000 compared with approximately $10,300,000 for the full year of 2022. As of December 31, 2023, cash and cash equivalents were approximately $4,700,000 We believe based on our current operating plan with the existing cash, cash equivalents including the proceeds from the recent public offering that we executed in February of 2024 as well as future cash flows from net product sales of Promote that will be sufficient to fund our operations into the Q4 of 2024. Speaker 500:27:54While we are seeing new prescription trends increasing through February, beginning of the year typically has higher co pay expenses for the company to cover and other discounting because of the changing coverage for patients and patients needing to meet their deductibles and or renewals of prior authorizations. Recently, we've also been watching the situation with Change Healthcare closely to see what impact this may have on our business. It is clear that all healthcare entities were impacted by this, not just pharmaceutical companies or Evoque. Although Evoque and Versana were able to put a solution in place within a week of the change healthcare outage, we are hearing from our partners and other industry experts that providers inability to check patient eligibility benefits or submit claims has started to impact new prescribing across the brands they support. And lastly, a new opportunity that has gained some attention over the last several months with the ongoing interest in GLP-one agonists, glucagon like peptide 1 agonist. Speaker 500:28:59Currently on the market is the association with gastroenterology side effects attributed to those products, particularly gastroparesis. We believe the increased use of GLP-one agonist could increase the number of people suffering from gastroparesis. GLP-one receptor agonists affect glucose control through several mechanisms, including enhancement of glucose dependent insulin secretion, slowed gastric emptying and reduction of postprandial glucagon and food intake. Slow gastric emptying may potentially lead to symptoms similar to gastroparesis. Although definitive evidence attributing GLP-one agonists specifically causing gastroparesis is limited, a recent study published in the Journal of American Medical Association found that the use of GLP-1s for weight loss compared with the use of bupropion naltrexone was associated with increased risk of pancreatitis, bowel obstruction and gastroparesis. Speaker 500:29:56While these adverse events from GLP-1s have been relatively rare, even a 1% incidence rate could have an impact on the gastroparesis market considering the gigantic population, very large population expected to be treated with GLP-1s in the future. And with that, operator, we've completed our formal remarks. I'll turn it over for questions. Operator00:30:21Thank you, sir. We do have a question from Yale Jin from Laidlaw and Company. Speaker 400:30:42Good afternoon and thanks for taking the question and congrats on the performance this year. I've got 2 or 3 short questions here. The first one is, as you mentioned about the Aspen pharmacy service that has improved your distribution. You have elaborated some, but could you give a little bit more color in terms of how that will impact on 2024 versus 2023 based on your estimates? Speaker 200:31:20Chris, you want to take that? Speaker 300:31:24Sure. And thank you all for the question. So, Aspen delivers a couple of different aspects of their platform that help us. 1 is, through efficient communication with patients, they get more patients to return phone calls and result in fewer abandonment of prescriptions. So that is a key to in fact, that's the largest reason for leakage in our prescription funnel is patients not calling us back. Speaker 300:31:57So they will significantly reduce that. The second thing is, is that they have strong relationships with payers and are integrated into those payer systems. So their efficiency in processing prescriptions and electronic prior authorizations is yielding a higher percentage of prescriptions that gain approval for those prior authorizations. And again, those approval of prior authorizations mean increased reimbursed scripts, which certainly will help us from a revenue perspective. And the last piece, and one that we're excited about too, is the fact that we are going to be adding pharmacies to our network through the Aspen network of pharmacies, which will give us access to pharmacies that have a strong contract with payers, including Medicaid. Speaker 300:32:50And Medicaid is an important aspect for our growth in 2024. Speaker 400:32:57And maybe just to tackle this question, Deepa's answer here. In terms of your pharmacy, what kind of a distribution geographic distribution in the United States, more local, regional or more nationally? Speaker 300:33:15Our current pharmacies have coverage in all contiguous 50 states. So, we have a good coverage from that perspective. As you can imagine, some states in terms of Medicaid require you to have a local pharmacy in order to distribute the product. So that's why adding pharmacies are going to be important to us. In certain of those states, we can't deliver a prescription even though we might have approval to do so. Speaker 300:33:46So we're strategically adding pharmacies that will augment our coverage, especially in Medicare and Medicaid. Speaker 400:33:55Okay, great. And then maybe the last question here is in terms of $14,000,000,000 sales guidance for 2024. Should we consider that a little bit conservative? Or how should we overall think about this guidance? Thanks. Speaker 500:34:12Yes. This is Matt. Yes, I guess we're not going to comment further on any further guidance. We're putting that out there in terms of what we believe is doable, what we've seen in terms of growth in the past. We believe that there's, as Chris said earlier, unlimited opportunity at this point. Speaker 500:34:30We haven't seen any curtailing of physicians' interest. We're in no way reaching some sort of significant market share yet with any of the targets that we're currently meeting with. So, we think this is appropriate and then very doable and that's what we're providing guidance at this time. Speaker 400:34:49Okay. Maybe just had one more question here. As you mentioned about the GLP-one drug that gastroparesis is one of expected side effects. Just curious up to now, have you ever treated patients that actually also taking the prescription of any of the GLP-one, would it be subcu or oral drug? Thanks. Speaker 500:35:14Yes. So Yale, it's a great question. I really appreciate you can open this up. I think it's really important for people to understand that GLP-1 is one of the key mechanisms of action. They do several different things related to the tidy curtailing sort of the cravings and other things. Speaker 500:35:31But it does also clearly slow down the GI tract. And by definition, delayed gastric emptying, that is what gastroparesis is. So whether or not patients who are mostly diabetic, and that's what the original indication was for, had gastroparesis beforehand, very mild perhaps, and then this addition of GLP-one sort of unmasked or exacerbated those issues. We're not certain exactly. And then or it would be completely de novo new patients coming on with us. Speaker 500:36:03We have read stories online of some persons claiming that it's totally de novo. They had no problems beforehand. I still think it's just early days around that. And then in terms of whether or not JYMOTI has been used with any of these patients, of course, we're not promoting for anything of that nature. We do receive prescriptions from physicians and will pursue authorization for whatever reason they so choose to write it for. Speaker 500:36:30I myself happen to have met a nurse practitioner who did have significant symptoms associated with her own treatment of herself with Wegovy and used Jomotie to treat herself and her symptoms with that. That was her decision, we found out after the fact. So and we also are hearing from physicians at the conferences, they're asking questions about utilizing JYMOTI to help patients with these problems because they do either do have gastroparesis or it mimics it very, very keenly. So I think physicians are starting to find their own ways to deal with these problems, which may in fact again be gastroparesis. And Speaker 200:37:11Yale, this is Dave. Just one thing I want to point out. So this was not in our forecast assumptions for 2024. Doesn't just be upside. So I want to make sure that's clear as well. Speaker 400:37:26Okay. That's great. And again, congrats on quite a nice performance so far. Speaker 200:37:34Thank you. Thank you, Ian. Operator00:37:39This concludes the Q and A portion of today's call. I would now like to turn the call back over to Matt D'Onofrio for any additional or closing remarks. Speaker 200:37:49Yes, thank you. Well, building on Speaker 500:37:51the momentum from 2023, our guidance for net revenue again is that $14,000,000 target for 2024. And that represents nearly a threefold increase from last year. This forecast is supportive our strategy, the investments and has been central and to strengthening healthcare providers' belief and the value of Jomotie. Again, we continue to strive for improved execution and the breadth of depth of prescription rates while continuing to invest in the evidence that supports Jomotie's outstanding brand. We look forward to sharing our progress over the course of the year and really appreciate you all for your continued support. Speaker 500:38:24Thank you very much and we'll close at this time, operator. Operator00:38:28Thank you, sir. This concludes the queue I'm sorry, this concludes today's Evoqua Pharma 4th quarter and full year 2023 earnings call and webcast. You may disconnect your line at this time and have a wonderful day.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallEvoke Pharma Q4 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Annual report(10-K) Evoke Pharma Earnings HeadlinesStockNews.com Begins Coverage on Evoke Pharma (NASDAQ:EVOK)April 13, 2025 | americanbankingnews.comEvoke Pharma, Inc. 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(EVOK) Q4 2024 Earnings Call TranscriptMarch 13, 2025 | seekingalpha.comSee More Evoke Pharma Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Evoke Pharma? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Evoke Pharma and other key companies, straight to your email. Email Address About Evoke PharmaEvoke Pharma (NASDAQ:EVOK), a specialty pharmaceutical company, primarily focuses on the development and commercialization of drugs for the treatment of gastroenterological disorders and diseases. It offers Gimoti, a metoclopramide nasal spray to treat symptoms associated with acute and recurrent diabetic gastroparesis in adults. The company markets its products to gastroenterologists, internal medicine specialists, primary care physicians, and select health care providers. 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There are 6 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Evoqu Pharma 4th Quarter and Full Year 2023 Earnings Conference Call. Currently, all callers have been placed in a listen only mode. And following management's prepared remarks, the call will be opened up for questions. Please be advised that today's call is being recorded. I'll now turn the call over to Daniel Canto of Boeing. Operator00:00:35Please go ahead, sir. Speaker 100:00:37Good afternoon and thank you for participating in Evolq Pharma's conference call and webcast today. With me today are Dave Gonyea, Evoke's Chief Executive Officer Chris Questenberry, Jamode's Chief Commercial Officer from Eversana and Matt Dionofio, Evoqu's President and Chief Operating Officer. By now, you should have a copy of the press release we issued earlier. If not, it is available on the Investor Relations page of our website at evokepharma.com. We encourage everyone to read today's press release as well as Evoque's Annual Report on Form 10 ks, which is now filed with the SEC. Speaker 100:01:16The company's Form 10 ks and earnings release are also available on Evoke's website. Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, management will be making forward looking statements. Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business. These forward looking statements are qualified by the cautionary statements contained in Eagle's press releases and SEC filings, including its annual report on Form 10 ks and subsequent filings. Speaker 100:02:00This conference call contains time sensitive information that is accurate only as of the date of this live broadcast. Evoque undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call and webcast. With that, I would now like to turn the call over to David Gonyea. Dave? Speaker 200:02:24Thank you, Daniel, and thanks everyone for joining the call this afternoon. As was described in today's press release, 2023 marked a milestone in Evoqua's journey, not just commercially, but also in fulfilling our core mission, which is ensuring Jumoti is within reach for every patient who needs it. Let me tell you why this core mission is so important. It's because it's about the patient and their experiences that can and will fuel the progress help us fuel the progress as an organization. A testament to our efforts comes from the countless positive stories we've been told from healthcare providers, patients and our own sales representatives who hear and tell us some amazing patient success stories on a daily basis. Speaker 200:03:10While gastroparesis impacts predominantly women, today I'd like to share just a brief, very inspiring story that was just shared to us this week about a 30 year old male who battles both type 1 diabetes and severe gastroparesis. This man who was in and out of the hospital just about every month because of his gastroparesis, shared with his health care provider that since starting on Jomotie, he hasn't had a single hospital visit, not one. And to his admission, it's been life changing for him. It's stories like these that will push payers, providers and advocates to fight for patients who suffer from this insidious disease so they can receive the best care possible. Now this is just one of many affirmations we have heard that continues to energize our commitment. Speaker 200:04:06Now while we're humbled to receive these stories of success, we also want to encourage providers to do more to diagnose and treat these patients with gastroparesis. But unfortunately, the norm for patients is to wait years before they're diagnosed and then often told there's not much they can do can be Speaker 300:04:24done for them. When Speaker 200:04:27treatment is prescribed, all too often payers are pushing the cost to the patient or outright denying coverage. Payers can do better and patients deserve better treatment. The compelling evidence for JIMOTI goes beyond anecdotes. The scientific groundwork, the publication of our Phase III clinical data and the peer reviewed and plenary presentations of our real world health resource utilization studies at leading gastroenterology congresses demonstrating a reduction in emergency room and hospital visits and the significant total healthcare cost savings compared to oral medical underscores the value of Jomotie versus the current gold standard. Our story is really simple and straightforward, and it's shaping up to be very compelling as well. Speaker 200:05:21PMOTI achieves rapid and direct absorption in the bloodstream. Jimodi provides documented symptomatic relief as early as 1 week and now Jimodi shows improved outcomes versus oral metoclopramide. The drug delivery through the nose avoids the problem of the disease, which is an inability to predictably deliver pills into the small intestine to be absorbed. Importantly, many patients previously on oral medical combined in the HRU study or the health resource utilization study who were switched to JIMOTI likely because they were not doing well experienced the same reduction in ER visits and hospitalizations while taking JIMOTI, confirming its place as a transformative medicine in gastroparesis treatment. Now let me switch gears a bit and turn to some highlights for 2023. Speaker 200:06:18I'm happy to report that we doubled our net revenue for Jomotie over the last year. The number of new prescriptions grew by a notable 86% and the total prescriptions dispensed increased by 101% year over year, clearly demonstrating the growing demand for Jomotic. We also augmented our prescriber base by 72% while amplifying the depth of their prescribing by 36%. Our commercial team's relentless focus propelled our targeting and outreach to healthcare providers, driving our financial achievements above our expectations. At important gastroenterology gatherings such as Digestive Disease Week and the American College of Gastroenterology Conferences, our data was selected by the respective governing boards for plenary presentations at both meetings. Speaker 200:07:14This is a testament to the strength and importance of the health resource utilization study we perform. This data highlighted Jomotie's role in significantly reducing ER visits and hospitalizations, outperforming oral menopoclopride and delivering care at a reduced price. This evidence not only resonated with GI professionals, but also underscores our commitment to patient care and economic efficiency for payers. Further in our strategic initiatives, we transitioned our pharmacy services to Aspen. The strategic alignment with Aspen's robust platform positions us to better meet our distribution needs, enhance patient access and streamline our services. Speaker 200:08:01And Chris will elaborate a little bit more on this in a moment. Looking back on a year of dynamic growth, our strategic investments have paid dividends. We've not only strengthened the belief in JIMOTI, but doubled the patient count on therapy. As we lean into 2024, we're aiming high with a projected net revenue of approximately $14,000,000 nearly tripling our 2023 performance. And with that, let me turn it over to Chris to talk about our current commercialization activities and plans moving forward for this year. Speaker 300:08:37Thanks, Dave. To confirm the uptake and acceptance that Dave just spoke about and revalidate last year's commercial strategy, we also took a look at providers consecutively prescribing JYMOVI after their initial script. This slide denotes that close to 30% of our cumulative prescribers, which total 1748 physicians, have prescribed JYMOVI 5 or more times. The writers that have written prescriptions continue to write more and more over time. From our standpoint, this is highly encouraging and a strong testament to the drug's efficacy and prescriber and user friendly profile. Speaker 300:09:15The unabated adding of new prescribers or so called breadth of prescribing in 2023, while simultaneously continuing to grow the depth of prescribing is difficult to do and is also an indication that there is still significant potential for growth for JYANOVI. We have not reached any ceiling of use for JYANOVI. Quite the opposite is true. While not shown on the slide, our market share of metoclopramide of the medical market shows similar gains throughout 2023. Encouragingly, as you look across important prescriber audiences, the share of JYMOTI compared to oral metoclopramide grew throughout 2023 and is progressively stronger as you move from all potential prescribers of JYMOTI to those that are in our call time target list and further improves as you look specifically at call time targeted gastroenterologists. Speaker 300:10:11Importantly, our highest share for JAMOTI is with nurse practitioners and physician assistants who provide a significant portion of the medical care for patients with gastroparesis as many gastroenterologists spend less time in clinic just deciding instead to perform procedures or scopes. As mentioned, our objective is to nearly triple our performance in 2023 or excuse me, in 2024. In 2023, we built a solid foundation and believe we have earned the right to challenge our provider and payer colleagues to offer JAMOTI to a broader base of patients within diastatic Throughout 2024 and beyond, our focus remains steadfast, reinforced the belief in JYMOTI amongst providers. Importantly, we will make clear that oral metoclopamine did not have the same healthcare resource utilization reductions that Jomodi provided and underscore that the nasal route of administration matters. For appropriate patients, we will ask providers to switch to Jumoti, thereby broadening and deepening prescribing. Speaker 300:11:18We have addressed improving the fill rate for JYMOTI and we'll continue this imperative throughout 2024. We earned a significant amount of prescribing of Jomotie in 2023 and much of it was unable to be filled because providers sent the prescription to a local retail pharmacy. We will use tools and partners to mitigate this and guide scripts to a pharmacy in our network to capture scripts appropriately. Lastly, we will increase our communication and education for target dyskinesia and leverage latent concerns to clarify risks and encourage appropriate benefit risk discussions. Here again, there is tremendous untapped potential to clarify appropriate use. Speaker 300:12:00We will be clear about who is inappropriate for Jomotene and request those who are appropriate to be offered Jumoni. Practically, here's how we plan to build on these initiatives. We will continue to promote and advocate for Jomotae as the optimal choice for gastroparesis treatment due to its optimized nasal administration. We will support this with our quantitative and qualitative healthcare utilization data. And currently, we are partnering with pharmacy organizations to leverage their systems and services to mitigate prescriptions that fall outside our distribution lines and never reach patients. Speaker 300:12:40Additionally, with Aspen Pharmacy joining our network, we will gain access to their extensive pharmacy distribution network, including specialty drug pharmacies, improving genomic fill rates and ensuring our patients receive the treatment they need without delay. Through appropriate channels, we'll also persist to demystify the risks associated with heart of dyskinesia or TD through education and transparency. For background, part of dyskinesia is a side effect of select medications more commonly seen with older antipsychotic medication that causes involuntary movements to one's face and body that can't be controlled. The recent ACG guidelines indicate the risk of this side effect due to exposure to metoclopramide is lower than previously thought. In fact, it's likely less than 1%. Speaker 300:13:30And our own claims analysis presented at PDW in 2022 confirmed ACG's conclusion. By presenting clear data, including the low incidence and which at risk patients to avoid, we are shifting the narrative from fear to informed prescribing and monitoring. We believe this will reset perceptions and encourage physicians to prescribe JYPTIVONEI to appropriate patients with confidence backed by a comprehensive understanding of its safety profile. As we build demand and utilization of Jomotie, we've taken deliberate strides to enhance the accessibility of Jomotie by evolving our distribution and pharmacy capabilities. Our journey began with Evocassist or Empsona Pharmacy, which allowed us to implement the system swiftly, though it relied on manual processes and had longer fulfillment times. Speaker 300:14:22As we progressed to VidaCare, we significantly upgraded our capabilities, integrating seamlessly with medical workflows, enabling electronic prescribing, facilitating automatic refills excuse me, automated refills to expedite the filling process. Now, with Ascendia, we've taken our distribution to the next level. Building on our previous advancements, Asymbia offers real time patient communication via text, complete end to end automation, including prior authorizations, and transparent prescription status through accessible portals to physicians and patients. This not only streamlines the prescription process for health care providers, but also ensures that patients receive their medication promptly. Most importantly, Ascendia's robust infrastructure and expansive pharmacy network position us to further scale our reach and positively impact patient outcomes. Speaker 300:15:17These strategic enhancements embody our commitment to optimizing Zimodia access and signify our unwavering dedication to patient care. Although we've only just initiated a partnership with Ascendia, also known as Aspen Pharmacies, in November of 2023, it's clear we've identified a critical lever for enhancing our flow rates. Through refined strategies and communication and process optimization within the Aspen platform, we've seen a tangible uptick in our conversion rates. Specifically, there's been a 2% overall increase in the number of new prescriptions filled. Even more impressive when we exclude in process prescriptions and improvement jumps to 22%. Speaker 300:16:01Moreover, we're seeing a significant shift towards greater efficiency with a 6% increase in sales that are reimbursed without the need for our patient affordability programs, a testament to streamline process and inherent value proposition of Jomotie. Additionally, Aspen's focus on and transparent patient communication is yielding results. With Aspen, there's been a 12% reduction in patient initiated abandonment of prescriptions, underscoring our commitment to ensuring that patients not only start to continue their treatment with JYMOTI as appropriate. These metrics are not just numbers. They represent real improvements in patient access and adherence, which are vital to our mission of providing JYMOTI to all who can benefit from it. Speaker 300:16:49These benefits will also fall to the bottom line. As we fortify our commitment to ensuring Jumoti reaches those in need, leveraging technology remains pivotal. By actively reminding healthcare professionals to write prescriptions directly to Ask them, pharmacies that point prescriptions within electronic medical records, we are addressing retail leakage effectively. Using this approach, we successfully made headway in intercepting scripts that initially intended to be prescribed to a retail pharmacy and successfully redirected over 1500 of them to our pharmacy, including Essent. We believe that strategic communication effort with prescribers, pharmacists and patients alike is critical to cementing Jomotie's presence in the market and improving patient outcomes. Speaker 300:17:41Based on this success, we have recently expanded our coverage and partnership with other EMR partners. Our messaging is now enabled in nearly half of all electronic health record systems and we have added new partners in Doctor. First and Connected Rx at the beginning of this month, ensuring that JYMOTI prescriptions pathway is even more clear and direct. Now last year, we unveiled 2 real world evidence studies that demonstrated the qualitative and quantitative value of Jomotie in addressing healthcare resource utilization of patients with diabetic gastroparesis. Image on the left hand side of the slide shows the inpatient hospitalizations were reduced by 68% in patients using Trimody compared to oral medical And it also shows emergency department visits were similarly reduced significantly by 60% in those taking JYMOTI versus oral medical fomile. Speaker 300:18:39The 257 patients taking JYMOTI experienced 34 fewer hospitalizations and 84 fewer ER visits over a 6 month period. That is a significant win for patients who can spend more time at home with their families who are doing simple things that we all take for granted. The reductions will also be a significant win for patients. Amazingly, looking to the right hand side of the slide, despite numerically larger prescription costs in the Jomotie arm, total healthcare costs, which is the sum of all medical costs and pharmacy costs in counters, were significantly lower, in fact, over $15,000 lower for patients taking JYMOTI than those taking generic oral metoclopramide over 6 month period of time. These data sets reinforce JYMOTI's clinical benefits and illustrates its profound potential economic impact. Speaker 300:19:38The substantial reductions in hospitalization and emergency department visits speaks volumes about its role in enhancing patient daily life and reducing the burden on our healthcare system. Moreover, the significant cost savings highlight Tsumovis' value proposition, marking it not only as a superior treatment option, but also financially responsible choice for healthcare providers and payers. I would argue that this is more than a win win. It's a new standard in the treatment of gastroparesis, setting a precedent for how we evaluate treatment, efficacy and cost effectiveness for patients with this debilitating disease and progressive disease. No other agent, in fact, no other modality used for gastroparesis has these types of breakthrough data demonstrating outcomes. Speaker 300:20:29And so we're going to test these data with payers. In fact, we're doing that right now with insurers, PBMs and IBMs alike through market research and asking them how these data might impact coverage decisions. We are in the midst of wrapping up this research, but what we are hearing from payers is that our healthcare resource utilization data has enough provocative elements to potentially impact the coverage decisions for Jomotie based on the same HRU data that I showed you on the previous slide. A significant portion of payers who are not currently covering Jomotie indicated the data presented would make them reconsider coverage decision, with 40% of them affirming outright and another 40% expressing willingness to reconsider with additional evidence of cost and savings. Additionally, of the payers who currently do provide coverage for JYMOTI, nearly half said they would further ease the process documentation requirements for obtaining JYMOTI. Speaker 300:21:26This preliminary feedback bolsters our conviction that providing robust evidence can shift perspectives. Payers are looking for more detailed analysis of cost saving drivers and peer review data to underpin credibility. We recognize this need for continuing evidence generation, focusing on key factors such as reduced hospitalization lengths, lower readmission rates and the overall reduction of the prescription burden. Additionally, the reduction of burden of illness, the avoidance of unnecessary medical procedures and assurance of safety are pivotal components that would enhance the value story of JYMOTI. Now one of the main reasons for hesitancy among providers to prescribe JYMOTI is the fact that JYMOTI carries a boxed warning for targeted dyskinesia similar to what oral MediClip might have in their TD is a movement disorder that causes involuntary immune to the face or body. Speaker 300:22:23Certainly, it can occur with mediclofimide, but TD is more commonly associated with antipsychotic medicines. We've come to appreciate that TD is a mystery for gastroenterologists. Who don't deal with it on a regular basis and there is a significant gap in their understanding of TD and how often it occurs. Their apprehension is leading many to avoid using imidaclofimide or reserve it for the more refractory patients. We need to shift this narrative from being afraid and avoiding to one of educated and monitor. Speaker 300:22:57We will leverage our label and the excellent information within it to help providers see that the box warning is a roadmap and the label information are at guardrails to help the provider avoid prospective patients at risk and thereby develop a clear understanding of the many appropriate patients who can benefit from JYMOTI. Speaker 400:23:19We will update HCPs with Speaker 300:23:21the most recent data and guidelines around the risk of TD with medical thromide, which again is likely less than 1%. We will educate on which patients to avoid and we will clarify that to date no TB has been reported in the clinical development program or since the launch of Jomodi in October of 2020. We will intensify our education efforts moving forward to ensure that providers can make informed benefit risk assessments when considering Jomotie for their patients. Our multi pronged approach includes educating our sales team with the latest insights on heart of dyskinesia, empowering motility specialists through symposia providing and providing our sales force with targeted resources. And lastly, engaging patients through their providers with education so they can make informed choices. Speaker 300:24:09We continue to engage KOLs within gastroenterology, but importantly have expanded to educate and inform ourselves with KOLs within psychiatry and neurology specialties like Peter McAllister of the New England Institute of Neurology and Headache. And this is to inform our own education efforts. Our commitment is to ensure that every stakeholder from healthcare providers to patients is fully informed about XERMOTI, thereby supporting its appropriate use and reinforcing our dedication to patient safety and well-being. With that, I'll turn the call over to Matt to review the financials and closing remarks. Speaker 500:24:49Thanks, Chris. Once again, thanks again for everyone joining today. I'll get right into Evoque's financials for the Q4 and full year end 2023 results. As Dave mentioned, for the Q4, net product sales were approximately $1,700,000 compared with $796,000 during the Q4 of 2022 and a net loss was approximately $2,000,000 or $0.59 per share compared with $1,800,000 or $0.54 per share for the Q4 of 2022. For the year ended December 31, 2023, net product sales were approximately $5,200,000 compared with approximately $2,500,000 for the year ended December 31, 2022 and the net loss was approximately $7,800,000 or $2.33 per share compared with a net loss of $8,200,000 or $2.62 per share for the year ended December 31, 2022. Speaker 500:25:41The year over year increase in revenue was due to higher net product sales in 2023 resulting from prescription sales through pharmacy service partnerships with Pharmacy, as Dave and Chris elaborated earlier, and capture of prescriptions sent to retail pharmacies that previously didn't have the ability to order product and sharing with providers and the GI community the exceptional head to head real world data comparing Jomotie to oral metoclopimide showing improvements in fewer hospitalizations and ER visits with Qimodie compared to oral. Research and development expenses totaled $23,000 for the Q4 of 2022 compared to $27,000 for the 4th quarter of 2023. For the full year 2022, research and development expenses were approximately $200,000 compared with approximately 0 point $3,000,000 for the prior year. For the Q4 of 2023, selling, general and administrative expenses were approximately $3,500,000 compared with $2,300,000 for the Q4 of 2022. For the year ended December 31, 2023 selling, general and administrative expenses were approximately $12,200,000 versus approximately $9,600,000 for the year ended December 31, 2020 2. Speaker 400:26:53The increase in SG and Speaker 500:26:54A costs year over year resulted primarily from higher marketing, royalty and Eversound profit sharing costs. We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of Genuity and we reimburse Eversana from the net profits attained from the sales of Genuity. Total operating expenses for the Q4 of 2023 were approximately $3,600,000 compared with $2,300,000 for the same period of 2022. And for the year ended December 31, 2023, total operating expenses were approximately $12,600,000 compared with approximately $10,300,000 for the full year of 2022. As of December 31, 2023, cash and cash equivalents were approximately $4,700,000 We believe based on our current operating plan with the existing cash, cash equivalents including the proceeds from the recent public offering that we executed in February of 2024 as well as future cash flows from net product sales of Promote that will be sufficient to fund our operations into the Q4 of 2024. Speaker 500:27:54While we are seeing new prescription trends increasing through February, beginning of the year typically has higher co pay expenses for the company to cover and other discounting because of the changing coverage for patients and patients needing to meet their deductibles and or renewals of prior authorizations. Recently, we've also been watching the situation with Change Healthcare closely to see what impact this may have on our business. It is clear that all healthcare entities were impacted by this, not just pharmaceutical companies or Evoque. Although Evoque and Versana were able to put a solution in place within a week of the change healthcare outage, we are hearing from our partners and other industry experts that providers inability to check patient eligibility benefits or submit claims has started to impact new prescribing across the brands they support. And lastly, a new opportunity that has gained some attention over the last several months with the ongoing interest in GLP-one agonists, glucagon like peptide 1 agonist. Speaker 500:28:59Currently on the market is the association with gastroenterology side effects attributed to those products, particularly gastroparesis. We believe the increased use of GLP-one agonist could increase the number of people suffering from gastroparesis. GLP-one receptor agonists affect glucose control through several mechanisms, including enhancement of glucose dependent insulin secretion, slowed gastric emptying and reduction of postprandial glucagon and food intake. Slow gastric emptying may potentially lead to symptoms similar to gastroparesis. Although definitive evidence attributing GLP-one agonists specifically causing gastroparesis is limited, a recent study published in the Journal of American Medical Association found that the use of GLP-1s for weight loss compared with the use of bupropion naltrexone was associated with increased risk of pancreatitis, bowel obstruction and gastroparesis. Speaker 500:29:56While these adverse events from GLP-1s have been relatively rare, even a 1% incidence rate could have an impact on the gastroparesis market considering the gigantic population, very large population expected to be treated with GLP-1s in the future. And with that, operator, we've completed our formal remarks. I'll turn it over for questions. Operator00:30:21Thank you, sir. We do have a question from Yale Jin from Laidlaw and Company. Speaker 400:30:42Good afternoon and thanks for taking the question and congrats on the performance this year. I've got 2 or 3 short questions here. The first one is, as you mentioned about the Aspen pharmacy service that has improved your distribution. You have elaborated some, but could you give a little bit more color in terms of how that will impact on 2024 versus 2023 based on your estimates? Speaker 200:31:20Chris, you want to take that? Speaker 300:31:24Sure. And thank you all for the question. So, Aspen delivers a couple of different aspects of their platform that help us. 1 is, through efficient communication with patients, they get more patients to return phone calls and result in fewer abandonment of prescriptions. So that is a key to in fact, that's the largest reason for leakage in our prescription funnel is patients not calling us back. Speaker 300:31:57So they will significantly reduce that. The second thing is, is that they have strong relationships with payers and are integrated into those payer systems. So their efficiency in processing prescriptions and electronic prior authorizations is yielding a higher percentage of prescriptions that gain approval for those prior authorizations. And again, those approval of prior authorizations mean increased reimbursed scripts, which certainly will help us from a revenue perspective. And the last piece, and one that we're excited about too, is the fact that we are going to be adding pharmacies to our network through the Aspen network of pharmacies, which will give us access to pharmacies that have a strong contract with payers, including Medicaid. Speaker 300:32:50And Medicaid is an important aspect for our growth in 2024. Speaker 400:32:57And maybe just to tackle this question, Deepa's answer here. In terms of your pharmacy, what kind of a distribution geographic distribution in the United States, more local, regional or more nationally? Speaker 300:33:15Our current pharmacies have coverage in all contiguous 50 states. So, we have a good coverage from that perspective. As you can imagine, some states in terms of Medicaid require you to have a local pharmacy in order to distribute the product. So that's why adding pharmacies are going to be important to us. In certain of those states, we can't deliver a prescription even though we might have approval to do so. Speaker 300:33:46So we're strategically adding pharmacies that will augment our coverage, especially in Medicare and Medicaid. Speaker 400:33:55Okay, great. And then maybe the last question here is in terms of $14,000,000,000 sales guidance for 2024. Should we consider that a little bit conservative? Or how should we overall think about this guidance? Thanks. Speaker 500:34:12Yes. This is Matt. Yes, I guess we're not going to comment further on any further guidance. We're putting that out there in terms of what we believe is doable, what we've seen in terms of growth in the past. We believe that there's, as Chris said earlier, unlimited opportunity at this point. Speaker 500:34:30We haven't seen any curtailing of physicians' interest. We're in no way reaching some sort of significant market share yet with any of the targets that we're currently meeting with. So, we think this is appropriate and then very doable and that's what we're providing guidance at this time. Speaker 400:34:49Okay. Maybe just had one more question here. As you mentioned about the GLP-one drug that gastroparesis is one of expected side effects. Just curious up to now, have you ever treated patients that actually also taking the prescription of any of the GLP-one, would it be subcu or oral drug? Thanks. Speaker 500:35:14Yes. So Yale, it's a great question. I really appreciate you can open this up. I think it's really important for people to understand that GLP-1 is one of the key mechanisms of action. They do several different things related to the tidy curtailing sort of the cravings and other things. Speaker 500:35:31But it does also clearly slow down the GI tract. And by definition, delayed gastric emptying, that is what gastroparesis is. So whether or not patients who are mostly diabetic, and that's what the original indication was for, had gastroparesis beforehand, very mild perhaps, and then this addition of GLP-one sort of unmasked or exacerbated those issues. We're not certain exactly. And then or it would be completely de novo new patients coming on with us. Speaker 500:36:03We have read stories online of some persons claiming that it's totally de novo. They had no problems beforehand. I still think it's just early days around that. And then in terms of whether or not JYMOTI has been used with any of these patients, of course, we're not promoting for anything of that nature. We do receive prescriptions from physicians and will pursue authorization for whatever reason they so choose to write it for. Speaker 500:36:30I myself happen to have met a nurse practitioner who did have significant symptoms associated with her own treatment of herself with Wegovy and used Jomotie to treat herself and her symptoms with that. That was her decision, we found out after the fact. So and we also are hearing from physicians at the conferences, they're asking questions about utilizing JYMOTI to help patients with these problems because they do either do have gastroparesis or it mimics it very, very keenly. So I think physicians are starting to find their own ways to deal with these problems, which may in fact again be gastroparesis. And Speaker 200:37:11Yale, this is Dave. Just one thing I want to point out. So this was not in our forecast assumptions for 2024. Doesn't just be upside. So I want to make sure that's clear as well. Speaker 400:37:26Okay. That's great. And again, congrats on quite a nice performance so far. Speaker 200:37:34Thank you. Thank you, Ian. Operator00:37:39This concludes the Q and A portion of today's call. I would now like to turn the call back over to Matt D'Onofrio for any additional or closing remarks. Speaker 200:37:49Yes, thank you. Well, building on Speaker 500:37:51the momentum from 2023, our guidance for net revenue again is that $14,000,000 target for 2024. And that represents nearly a threefold increase from last year. This forecast is supportive our strategy, the investments and has been central and to strengthening healthcare providers' belief and the value of Jomotie. Again, we continue to strive for improved execution and the breadth of depth of prescription rates while continuing to invest in the evidence that supports Jomotie's outstanding brand. We look forward to sharing our progress over the course of the year and really appreciate you all for your continued support. Speaker 500:38:24Thank you very much and we'll close at this time, operator. Operator00:38:28Thank you, sir. This concludes the queue I'm sorry, this concludes today's Evoqua Pharma 4th quarter and full year 2023 earnings call and webcast. You may disconnect your line at this time and have a wonderful day.Read morePowered by