Evoke Pharma, Inc. (NASDAQ:EVOK) Q4 2023 Earnings Call Transcript

Page 2 of 2

The year-over-year increase in revenue was due to higher net product sales in 2023 resulting from prescription sales through pharmacy service partnerships with ASPN Pharmacy, as Dave and Chris elaborated earlier. We captured prescriptions sent to retail pharmacies that previously didn’t have the ability to order product, and sharing with providers in the GI community the exceptional head-to-head real-world data comparing GIMOTI to oral metoclopramide showing improvements in fewer hospitalizations and ER visits with GIMOTI compared to oral. Research and development expenses totaled $23,000 for the fourth quarter of 2022, compared to $27,000 for the fourth quarter of 2023. For the full-year 2022, research and development expenses were approximately $0.2 million, compared with approximately $0.3 million for the prior year.

For the fourth quarter of 2023, selling, general and administrative expenses were approximately $3.5 million, compared with $2.3 million for the fourth quarter of 2022. For the year ended December 31, 2023, selling, general and administrative expenses were approximately $12.2 million, versus approximately $9.6 million for the year ended December 31, 2022. The increase in SG&A costs year-over-year resulted primarily from higher marketing royalty and Eversana 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 GIMOTI and we reimburse Eversana from the net profit obtained from the sales of GIMOTI. Total operating expenses for the fourth quarter of 2023 were approximately $3.6 million, compared with $2.3 million for the same period of 2022.

And for the year ended December 31, 2023, total operating expenses were approximately $12.6 million, compared with approximately $10.3 million for the full year of 2022. As of December 31, 2023, cash and cash equivalents were approximately $4.7 million. 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 at GIMOTI, that that will be sufficient to fund our operations into the fourth quarter of 2024. While 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 the 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 health care entities were impacted by this, not just pharmaceutical companies or Evoke. Although Evoke and Eversana 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 was the ongoing interest in GLP-1 agonist or our glucagon-like peptide-1 agonist. Currently on the market is the association with gastroenterology side effects attributed to those products, particularly gastroparesis.

We believe the increased use of GLP-1 agonist could increase the number of people suffering from gastroparesis. GLP-1 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-1 agonist 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.

While 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, and I’ll turn it over for questions.

Operator: [Operator Instructions] We do have a question from Yale I-Eh Jen from Laidlaw & Company.

Yale Jen: And congrats on the performance this year. I’ve got two or three questions here. The first one is, as you mentioned about the ASPN 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 evidence?

David Gonyer: Chris, do you want to take that?

Christopher Quesenberry: Sure. And thanks, Yale, for the question. So ASPN delivers a couple of different aspects of their platform that help us. One 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. So 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 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 ASPN network of pharmacies, which will give us access to pharmacies that have strong contract with payers, including Medicaid. And Medicaid is an important aspect for our growth in 2024.

Yale Jen: And maybe just a tack on this question, to answer here, in terms of the pharmacy, what kind of a distribution — geographic distribution in the United States, more local or regional or more nationally?

Christopher Quesenberry: Our 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. So we’re strategically adding pharmacies that will augment our coverage, especially in Medicare and Medicaid.

Yale Jen: Okay. Great. And then maybe the last question here is in terms of $14 million sales guidance for 2024. Should we consider that as a little bit conservative? Or how should we overall think about this guidance? And thanks.

Matthew D’Onofrio: Yes, 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. We 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 very doable, and that’s what we’re providing guidance at this time.

Yale Jen: Okay. Maybe just one more question here. As you mentioned about GLP-1, 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-1 whether that be subcu or oral drug?

Matthew D’Onofrio: Yes. Yale, it’s a great question. I really appreciate you opening 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 satiety curtailing, sort of the cravings and other things. But it does also clearly slow down the GI track. 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 the GLP-1 sort of unmasked or exacerbated those issues, we’re not certain exactly. And then — or is it completely de novo new patients coming on with this.

We 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 GIMOTI has been used with any of these patients, of course, we’re not promoting for anything in that nature. We do receive prescriptions from physicians and will pursue authorization for whatever reason they so choose to write it for. I myself happen to have met a nurse practitioner who did have significant symptoms associated with her own treatment of herself with WEGOVY and used GIMOTI to treat herself and her symptoms with that. That was her decision, we found out after the fact. And we also are hearing from physicians at the conferences, they’re asking questions about utilizing GIMOTI to help patients with these problems.

Because they do — either do have gastroparesis or mimics it 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.

David Gonyer: And Yale, this is Dave. Just one thing I’m going to point out. So this was not in our forecast assumptions for 2024, just be upside. So I want to make sure that’s clear as well.

Yale Jen: Okay. That’s great. And again, congrats on quite a nice performance so far.

Operator: This concludes the Q&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.

Matthew D’Onofrio: Yes. Thank you. Well, building on the momentum from 2023, our guidance for net revenue again is that $14 million target for 2024. And that represents nearly a threefold increase from last year. This forecast in support of our strategy, the investments and has been central to strengthening health care providers’ belief in the value of GIMOTI. 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 GIMOTI’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. Thank you very much, and we’ll close at this time, operator.

Operator: This concludes today’s Evoke Pharma fourth quarter and full-year 2033 earnings call and webcast. You may disconnect your lines at this time. And have a wonderful day.

Follow Evoke Pharma Inc (NASDAQ:EVOK)

Page 2 of 2