Evoke Pharma Q4 2024 Earnings Call Transcript

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March 13, 2025
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Operator

Good afternoon, and welcome to the Evoqu Pharma Fourth Quarter and Full Year twenty twenty four 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 for your questions.

Operator

Please

Operator

I would now like to turn the call over to Daniel Quintobotang. Thank you, sir. You may begin.

Daniel Kontoh-Boateng
Corporate Communications & Investor Relations at DKB Partners

Good afternoon, and thank you for participating in Evoke Farmers' conference call today. With me today are Matt Giannaprio, Evoke's Chief Executive Officer Chris Kletzenberry, Jamudi's Chief Commercial Officer from Eversana and Mark Kowieski, Evoke's Chief Financial 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 evokedpharma.com. We encourage everyone to read today's press release as well as Evoke's annual report on Form 10 K, which is now filed with the SEC.

Daniel Kontoh-Boateng
Corporate Communications & Investor Relations at DKB Partners

The company's Form 10 K 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, uncertainties associated with the company's business. These forward looking statements are qualified by the cautionary statements contained in Evo's press releases and SEC filings, including its annual report on Form 10 K and subsequent filings.

Daniel Kontoh-Boateng
Corporate Communications & Investor Relations at DKB Partners

This conference call contains time sensitive information that is accurate only as of the date of this live broadcast. Eagle undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over to Matt D'Onofrio. Matt?

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

Thank you, Daniel. Good afternoon, everyone. Thanks for joining today. Starting with a story to keep our focus on why we're working so tirelessly to help persons suffering from gastroparesis. This quote here from a real person that understands why we do what we do with Ava Pharma.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

Position The physician recently described to us 23 year old patient, especially in the ER eight times in the prior six months to him receiving our medication. He had lost his job, moved back and moved back in with his parents, and he dropped below one hundred pounds. He and his mother were desperate for a solution. One month after starting at JEMODE, he had not returned to the hospital. He started gaining weight, and he had only experienced one episode of vomiting.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

He missed a dose. That's the kind of life changing impact we aim to deliver. Stories like these drive us forward and reinforce our mission to make a meaningful difference in the lives of gastric patients. 2024 was another growth year for Evoque Pharma. It was a year when we executed our strategy, gained traction in the market, delivered strong financial results.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

We achieved 10,200,000.0 total revenue, reflecting a ninety seven year over year increase of higher than a prior 9,500,000.0 guidance. Q4 revenue of 3,300,000.0, a 24.6% sequential increase. A major driver of this growth was the expansion of Jomotie's prescriber base and improved prescription fulfillment. The transition to Aspen pharmacies played a crucial role in this, significantly accelerating the delivery time of Jomotie and rapid adjudication of insurance authorizations for patients. This, along with our growing provider engagement, led to a 46% increase in prescribers year over year, bringing our total cumulative prescriber base to 2,553.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

Additionally, fill rates increased 72% year over year and patient enrollments grew 22%. Our corporate position continues to improve with two additional Orange Book listed patents that were allowed in 2024 and recently posted in the FDA website. We now have six listed patents related to JAMODE into 02/1930. Additionally, the recent Vanda CRL and FDA's posted notice on domperidone discontinuation via the Compassionate Use Program further emphasized the critical need for JAMODE. JAMODE remains the only approved product to treat this disease that has any evidence of improvement over prior standard of care oral mediclutamide.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

We continue to capture stories of patients that are not adequately treated with oral medications and find relief with JAMODE, the only non oral and reliable FDA approved nasal treatment for gastroparesis. Evoque remains the only company positioned to elevate treatment for this devastating disease. Now we'll turn to Chris to recap our commercial progress over the course of 2024 and plans moving forward into 2025.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Thanks, Matt. Good afternoon, everyone. To reinforce Matt's summary of 2024, in addition to improving the efficiency of our processes with our absent partner pharmacy, we had a number of milestone

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

moments in 2024

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

that helped us to achieve the growth that Matt described. We expanded our pharmacy distribution network to create redundancy in key markets and mitigate loss of out of network scripts in other markets. We continue to build evidence supporting the utilization of Gemoti and challenge the use of orometoclax as the standard of care for patients with gastroparesis. And we improved our execution in the field and overall by launching a fully integrated omnichannel program powered by artificial intelligence and launched a new marketing campaign focused on Switch. Our message is being heard and recognized in various channels, including awards and presentations at conferences, attendance and sponsored speaking programs, and publications of our data.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Beyond commercial execution, we have also made meaningful strides in clinical validation. Our health care resource utilization or HRU data has continued to reinforce the value proposition of Genovese. At ACG in October of twenty twenty four, we presented data evaluating the impact of Jomotie, our FDA approved metoclopramide nasal spray in patients with diabetic gastroparesis who were simultaneously taking GLP one receptor agonists. This research highlights Jomoni's role as a potential supportive therapy for GLP one users experiencing gastroparesis symptoms. Furthermore, given the frequent questions and interest from providers on this topic, we are now integrating this data into our educational efforts.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

ACD was a defining moment for us. Not only did we receive the presidential poster award, but our larger booth presence allowed us to engage with hundreds of physicians, double the number of interactions from last year, many of whom were learning about your buddy for the first time and a good number of who specifically sought us out. This underscores what we already believe. We are just scratching the surface in terms of marketing market presentation. Awareness remains a top priority, and with Arizona's expanded efforts, we are well positioned to accelerate broad provider education and drive adoption.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Again, to emphasize the impact of working with Aspen over the past year, this transition has been one of the most effective commercial strategies we've implemented. It has not only streamlined prescription fulfillment, but it has also improved the overall patient experience, producing frustration and improving adherence. Aspen's high patient retention rates helps to ensure that more patients stay on therapy, which is critical for improving outcomes and supporting provider confidence in prescribing to those. The results of these adjustments to strategy and tactical moves is that we were able to double revenue in 2024 from 2023. In fact, we've doubled revenue two times over the last two years.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We are making an impact in the market and showing that we can impact both providers' behaviors as well as our own processes to continue to build on the performance of GEDOTI. We took big strides in the second and fourth quarter of last year and plan to continue progress towards growing business and market share as well as breadth of prescribing for Genovese. In fact, as we continue to add new prescribers to the range of Genovese, the depth of prescribing continues to grow. On average, we add between sixty five and seventy five new prescribers each month to generally write for their first prescription. And yet we still continue to see the depth of prescribing per physician continue to grow and is now at nearly six and a half scripts per prescriber.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We believe neither of these trends show signs of slowing and underscores the fact, again, that we've only scratched the surface for this brand in this market, and there is and continues to be significant upside potential. When we look at patients and the average number of number of months on therapy, the trends are remarkably similar to the ones you see on this graph. They continue to grow, and they show no signs of abating either. I'm excited because we continue to see signs of repeat patients with prescription renewals, strong refill rates, and overall filler rates that are cumulatively catching up to cumulative prescriptions and launch. Let's now look at the efficacy of key components of our program.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

There are several improvements we have made within our processes, communication and education, and coordination with our pharmacy part in NASHMA. They have leading capabilities in communicating and onboarding patients, reporting and transparency, and tools for providers to support access for patients to important medications like Jomotene. We are focused on streamlining the process and integrating it into the provider's workflow as much as possible. A significant indicator of those efforts is seeing a meaningful rise in conversion rate over the course of the year. The quality of those same adjustments is reflected in the improvement in the conversion rate for each payer type throughout the year.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

In addition to improvements with the processes of Aspen, we added capacity and coverage by expanding our distribution network by seven dispensing pharmacies. These partnerships have helped us patch holes in a payer system that in some instances requires pharmacies to be part of Altavian's network of pharmacies, where in others requires them to be within the state where the prescription is filled. We had these pharmacies throughout the year, which contributed to a 30% faster speed therapy for patients, which is essentially the time between prescription intake and the receipt by the patient of Genovese. A significant reduction in out of network prescriptions, and increased overall conversion and reimbursement. This yielded a growth in year over year expenses by 72%.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Importantly, when patients get their prescriptions filled, it increases both their confidence and prescriber confidence, which is a very important currency for us. No matter what the market, data is same, and the gastroparesis market is not different. While we have a nasal route administration that demonstrated faster bioavailability and clinical trial efficacy that shows relief of symptoms, previously, we couldn't answer two critical questions that physicians had. First, does the rate nasal met Brown administration really matter? And second, are you doing better than oral metoclopramide?

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Our retrospective real world data and perhaps one of the largest studies of patients with gastroparesis was a significant step towards answering those questions. We demonstrated JIMODI was significantly better than oral medico combined in reducing ER visits and hospitalizations. Emphasizing the point, nearly two thirds of patients in the gymnasium previously took oral metacopramide. So by switching from oral to the nasal route of administration, the patients achieved better results. In fact, it somewhat answers a third important question, which is if a patient is not doing well on oral metoclopamine, would they seek benefit by switching to Jiveli?

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We think the answer is yes. So on with these data, we feel confident that we can move to money for our product providers are willing to try to a product they rely upon. So we've taken this message to the market, and we've initiated a definitive switch campaign. And we supercharge that with an omnichannel campaign powered by artificial intelligence that we launched at the beginning of q four last year. Our message is reaching a broader audience with a faster cadence and a more reliable presence than ever before.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We believe we have high commitment within our sales team and a significant engagement with our providers. In fact, we've been able to improve our reach to targeted positions to 60%, make more than 2,000 additional calls that we wouldn't have been able to make beforehand, and send content over email that was engaging enough to compel a 15% open rate versus an industry average of 2%. Qualitatively, we know we're having impact because more providers are seeking Jomode out rather than us introducing Jomode to them. And providers are asking more questions and digging deeper into our data. As I transition from accomplishments in 2024 to double net revenue, We need to dig deeper into 2025 to achieve our own performance and expectations.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We need to build on those momentum we've earned and not rest on those achievements. As I said, it will only scratch the surface, and there's so many more patients who we can potentially help. One area where there's still significant room for impact is on the pharmacy side, and doing so in a strategic and thoughtful manner. Within gastroenterology, the landscape has been changing pretty dramatically, and thousands of providers are now part of very large GI practice organizations. These organizations are purpose built to harmonize on shared operational needs and to scale office services to patients, hospital systems, and payers.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Based on their slides, they have increasing clout, and many of them have preferred specialty pharmacies they work with. And our goal is to meet them where they're at. We have many common goals and objectives, primarily set it on approved patient care and wanting a streamlined process. By adding pharmacies here and in this way, we believe it will be additive to our business. As we grow volume and continue to obtain higher authorization, we're going to invest in improving this process as well.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

And I'm really excited to announce that we recently added four field reimbursement managers or FRMs and a leader to serve as a resource to prescribers in the prior authorization process. Currently, only 50% of them are being completed. We have demonstrated though that we can improve the completion rate with our sales team, but that took them off the task of selling. By deploying FRMs, we help both to solve a pain point for prescribers that has to obtain prior authorizations, which will take them away from patient care. And we solve a pain point for ourselves by increasing completion quality of prioritizations.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We expect this to impact conversions, gross to net, and again, overall confidence in prescribing. And we're going to continue to invest in evidence generation and education to reinforce that Jaboty should be the standard of care. We will continue to feature our health care resource and reduction data prominently. As I mentioned earlier, recently, we have provided data to the growing discussion about GLP one youth and the association with symptoms like nausea, vomiting, gastroparesis. In a sub analysis analysis of our HRU data in ninety one ninety two patients, we show that patients taking Jomoty fared better than patients taking oral metoclopramide across different health care visits.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

At least these are limited, we believe Jomotie can be an option for patients on a GLP one who have diabetes and suffer from gastroparesis. This pillar of evidence will continue to be an important part of Jim Modi and will further entrench the brand in the market today and serve to differentiate Jim Modi against future of insurance. In summary, we are ambitious about our plans and goals for 2025. We set some solid groundwork and have made adjustments to capitalize on our opportunity and diminish our challenges. Our aim is to continue to build on our performance.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We are strategically partnering with both pharmacies, improving the prior authorization process, expanding our share of voice and improving our execution, adding to the reasons to believe that Jamoti should have the data, and continuing to challenge ourselves on where else Jamoti might add value to patients and providers. With that, I'll turn the call over to our Chief Financial Officer, Mark, to go over the financials.

Mark Kowieski
Mark Kowieski
CFO at Evoke Pharma Inc

Thanks, Chris. Once again, thank you for all joining us this afternoon. I'll get a right into Evoque's financials for the fourth quarter and full year end twenty twenty four results. As Matt mentioned, for the fourth quarter of twenty twenty four, net product sales were approximately $3,300,000 compared with $1,700,000 during the fourth quarter of twenty twenty three, and a net loss of approximately $1,200,000 or $0.49 per share compared with $2,000,000 or $7.13 per share for the fourth quarter of twenty twenty three. For the year ended 12/31/2024, net product sales were approximately $10,200,000 compared with approximately $5,200,000 for the year ended 12/31/2023.

Mark Kowieski
Mark Kowieski
CFO at Evoke Pharma Inc

And the net loss was approximately $5,400,000 or $2.81 per share paired with a net loss of $7,800,000 or $27.97 per share for the year ended 12/31/2023. The year over year increase in revenue was due to the higher net product sales in 2024 resulting from prescription fulfillment through the Aspen pharmacy network, robust commercialization efforts and increased provider awareness through marketing of head to head real world data demonstrating the modi healthcare resource utilization benefits over oral mediclopramide. There were no research and development expenses incurred during the fourth quarter of twenty twenty four compared to $23,000 for the fourth quarter of twenty twenty three. For the full year of 2024, research and development expenses were approximately $16,000 compared with approximately $200,000 for the prior year. For the fourth quarter of twenty twenty four, selling, general and administrative expenses were approximately $4,400,000 compared to $3,500,000 for the fourth quarter of twenty twenty three.

Mark Kowieski
Mark Kowieski
CFO at Evoke Pharma Inc

For the year ended 12/31/2024, SG and A expenses were approximately $15,100,000 versus approximately $12,200,000 for the year ended 12/31/2023. The increase in SG and A cost year over year resulted primarily from higher marketing and Eversana product sharing costs. We expect that SG and A expenses will increase in the future as we continue to progress with the commercialization of Jomodi and we reimburse Eversana from the sales of Jomodi. Total operating expenses for the fourth quarter of twenty twenty four were approximately $4,500,000 compared to $3,600,000 for the same period of 2023. For the year ended 12/31/2024, total operating expenses were approximately $15,500,000 compared with approximately $12,600,000 for the full year of 2023.

Mark Kowieski
Mark Kowieski
CFO at Evoke Pharma Inc

As of 12/31/2024, cash and cash equivalents were approximately $13,600,000 dollars We believe, based on our current operating plan, that our existing cash and cash equivalents, including proceeds raised from financing in 2024, as well as future cash flows from net product sales at Jomotie, will be sufficient to fund our operations into the first quarter of twenty twenty six. It's worth reiterating that one of the biggest financial milestones of 2024 was our $14,300,000 capital raise, which was achieved through equity financings and warrant exercises. This funding has allowed us to ensure NASDAQ compliance and extend our cash runway into Q1 twenty twenty six, giving us the financial flexibility we need to execute operations smoothly and expand market access. We have a strong financial outlook for 2025. As noted in our press release, we are projecting net revenue guidance of approximately $16,000,000 which represents a 60% increase over 2024 net revenue.

Mark Kowieski
Mark Kowieski
CFO at Evoke Pharma Inc

This projection is built on the momentum we've established, improved reimbursement pathways and increasing prescription fills. Of course, as with any guidance, this outlook also considers external factors outside our control, such as macroeconomic conditions, supply chain constraints and inflationary pressures. That said, we remain highly confident in our ability to execute and continue delivering strong results. And with that, we'll open the call to questions. Operator?

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

We'll take our first question today from Yale Chen with Laidlaw and Company.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

We have two questions here. The first one, I just want to look at the competitive landscape that you have, the advantage of the How do you see that could impact on the competitive landscape? And what do you feel that the compassion use of the scope of the compassion use drug and how much that could potentially be in the kind of you could capture some of those?

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

Sure, sure. I'll make a comment and then maybe Chris, you can chime in. It's really hard to know exactly what will happen in terms of the domperidone component. We don't know when it will finally run out. We know that they said sometime this year.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

You know, obviously, there are patients that are out there taking it through that mechanism. The exact number is not reported anywhere, so we don't know. We also know that some patients get illegally shipped in from Canada or other countries externally, which will probably continue as well. We recognize that there's just a big need for product and it's most likely going to end up in some way falling into our laps in terms of those patients are probably going to end up having to turn to an alternative like Jumoti. I'll stop with that and maybe Chris you can further chime in.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

I agree, Matt. It's not clear the volume, but what is clear is that yet another option is no longer available for patients sometime later this year. That continues to cement Evoque as a leader in this market and as patients and their providers turn to options, then we we will be there as, as an option for it.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay. Great.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

That's very helpful. Maybe a follow-up question here that, I remember a few quarters, in the private quarters, you guys have something about increase of Medicaid credit care and Medicaid, like, probably Medicaid, pharmacies in different states. Any update on that at that front? Thanks.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

Yeah. Chris, why don't you take this one?

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

Yes. So that strategy that I mentioned earlier has helped us. And you saw earlier in the slide that conversion rate of Medicaid and Medicare scripts has increased over the year, and part of that reason is because we have brought up more of those seven additional dispensing policies. Medicaid, as an example, has gone from about 2% of our business, at the early part of, 2024. So now between 57%, you know, to take upon the month.

Chris Quesenberry
Chris Quesenberry
Chief Commercial Officer - GIMOTI & Commercial Lead at Evoke Pharma Inc

So it's growing. And as we, demonstrate to providers that we can fill those prescriptions, we we believe that will continue to grow.

Operator

Okay. Great. That's very helpful.

Operator

Again, congrats, and thanks for looking for the question. Okay. And there are no further questions on the line at this time. So this concludes the Q and A portion for today's call. I would now like to turn the call back over to Matt D'Annaprio for any additional or closing remarks.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

Sure. Hey, before we conclude the call, I want to take a moment to reflect on where we are heading. Looking ahead into 2025 and beyond, our strategy remains clear, Expand pharmacy partnerships to continue improving access, increase provider awareness and engagement to drive broader adoption of Jomotie, leverage real world data to strengthen payer discussions and reinforce Jomotie's value, Continue improving prescription fulfillment rates to reduce leakage and abandonment. And as per our mindset since Invoke's inception, maintain a disciplined approach to capital allocation, ensuring we maximize the return on every dollar invested in commercialization. We've built strong momentum and we are in a great position to capitalize on the foundation we've laid over the past year.

Matthew D'Onofrio
Matthew D'Onofrio
Co-Founder, CEO & Director at Evoke Pharma Inc

With the right commercial infrastructure, strong strategic partnerships and growing clinical validation, we believe Jomodie is on its way to becoming the standard of care for gastroparesis treatment. We're looking forward to sharing our progress over the course of the year and thank you for your continued support.

Executives
    • Matthew D'Onofrio
      Matthew D'Onofrio
      Co-Founder, CEO & Director
    • Chris Quesenberry
      Chris Quesenberry
      Chief Commercial Officer - GIMOTI & Commercial Lead
    • Mark Kowieski
      Mark Kowieski
      CFO
Analysts
    • Daniel Kontoh-Boateng
      Corporate Communications & Investor Relations at DKB Partners
    • Yale Jen
      Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company
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