Eton Pharmaceuticals - Q2 2024

Transcript

Operator (participant)

Good afternoon, and welcome to the Eton Pharmaceuticals Second Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Chief Business Officer at Eton Pharmaceuticals. Please proceed.

David Krempa (Chief Business Officer)

Good afternoon, everyone, and welcome to Eton's second quarter 2024 conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on today's call. The release is available on our website, etonpharma.com. Joining me on our call today, we have Sean Brynjelsen, our CEO, and James Gruber, our CFO. In addition to taking live questions on today's call, we will be answering questions that are emailed to us. Investors can send their questions to [email protected]. Before we begin, I would like to remind everyone that remarks made during this call may contain forward-looking statements and involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC.

Now, I will turn the call over to our CEO, Sean Brynjelsen.

Sean Brynjelsen (CEO)

Thank you, David. Good afternoon, everyone, and thank you for joining us today. We are pleased to be reporting yet another quarter of record product sales. Eton began 2024 with high expectations across all areas of the business, and now that we've reached the midpoint of the year, I'm proud to say we're executing on all fronts. We've continued to rapidly grow sales of our existing commercial products, while also delivering on the advancement of our pipeline products, most notably ET-400, and we were able to do all of this while generating positive cash flow from operations in the second quarter. I could not be happier with our corporate performance so far this year. The second quarter was Eton's 14th straight quarter of sequential product sales growth.

We are very proud of this streak, and based on our portfolio's long runway for growth, we expect this streak to continue for the foreseeable future. Product sales increased 40% year-over-year to $9.1 million in the quarter and grew 14% over the previous high in the preceding quarter. Absent any unannounced M&A transactions, we expect to reach positive GAAP net income by the end of this year. These impressive results were primarily due to continued strength from both of our lead products, Alkindi Sprinkle and Carglumic Acid. Alkindi Sprinkle saw its growth accelerate in the second quarter, as we have seen a strong uptick in the number of new patient referrals received this year. Alkindi revenue increased an impressive 63% year-over-year.

Given that Alkindi is our highest margin product and one which we believe has the largest market opportunity, we are very pleased to see this acceleration of growth. Sales are benefiting from several key initiatives, including our team's strong presence at endocrinology medical conferences during the first half of the year, the initiation of our sampling program, and the improved productivity of our internal sales force. We are now in the second year of having our full internal sales force in place, and we are seeing the results of our team strengthening relationships that they worked hard to develop over the last 18 months in their respective territories. Eton now has more than 400 active patients on therapy, and we estimate that this only represents 10% of the target market, so we still have a long ways to go.

On the metabolic side of our portfolio, Carglumic acid continues to shine. Once again, the product is exceeding our expectations, and we are happy with the performance. Carglumic posted record revenue in Q2, and we have already added additional new patients in July, so we expect the revenue growth to continue. Sticking with the metabolic portfolio, we were excited to announce the acquisition of PKU GOLIKE in March, and we have now fully relaunched the product with our commercial organization. Patients who suffer from phenylketonuria, also known as PKU, lack the enzyme needed to break down phenylalanine, an amino acid found in protein. The consumption of protein, regular protein can result in a buildup of this amino acid, which may result in neurological issues. To combat this, an estimated 8,000 PKU patients in the U.S. rely on specialized protein medical formulas, such as PKU GOLIKE.

PKU GOLIKE was a strong strategic fit for Eton because the condition is managed by metabolic geneticists, the same healthcare professionals that we are actively engaged with on our other metabolic products. We also view GOLIKE as a best-in-class product because it offers a variety of formats, including a unique bar. It is significantly better tasting than the competing products and has a delayed-release technology designed to keep patients full for longer periods of time. In addition to these compelling benefits, the acquisition of GOLIKE offered meaningful financial upside. We paid less than 2x revenue for the asset, even though GOLIKE was, and is still early in its launch, with significant revenue left to capture. In mid-April, our sales team relaunched GOLIKE at the Genetic Metabolic Dietitians International Conference and received immediate strong interest.

We've already seen an uptick in new patient referrals since our promotional activities have begun, and we continue to work towards our goal of achieving 10% market share of the estimated $100 million market for PKU medical foods in the U.S. Eton has also continued to add patients on Betaine and Nitisinone. Although the revenue impact for these two products is significantly lower than Carglumic Acid, they have further strengthened our relationship in the metabolic geneticist community, increasing the frequency of interactions with potential Carglumic Acid prescribers, and now offering an additional opportunity to promote PKU GOLIKE. Turning to our development pipeline, over the past several quarters, you've heard me discuss the importance of our pipeline candidate, ET-400, our proprietary patented formulation of Hydrocortisone oral solution.

This formulation is in high demand from patients, caregivers, and physicians, and if approved, would complement Alkindi Sprinkle and provide an alternative for the large contingent of patients, potentially several thousand, who prefer a liquid product. Currently, these patients are either creating their own homemade suspension by mixing crushed tablets with water or using a compounded product that is not FDA approved. During the second quarter, we completed our NDA submission for ET-400 to the FDA. Last month, we received the exciting news that the NDA was accepted for review. We're thrilled to be one step closer to bringing this critical medication to patients in need. The FDA has assigned our application a PDUFA target action date of February twenty-eighth, two thousand and twenty-five, and I have initiated launch preparation activities accordingly. We plan to begin production of commercial product in the fourth quarter of this year.

We expect to be in a position to launch ET-400 quickly upon its anticipated approval in February. Once approved, we believe ET-400 will allow us to capture a greater percentage of the oral hydrocortisone market, and together with Alkindi Sprinkle, achieve combined peak sales of more than $50 million annually. As you know, we are very excited about this product's potential. We believe growth of our existing portfolio, combined with the ET-400 launch, sets Eton up for a major inflection point in 2025. We've also made steady progress with ET-600, our product candidate under development for the treatment of diabetes insipidus. This product has passed its pilot bioequivalence study, and we are on track to complete a pivotal study over the next several months. We expect to submit the NDA early in 2025 for potential approval ten months later.

In addition to growth from our commercial products and near-term pipeline candidates, we continue to pursue opportunities to grow business development. We believe we are in a very attractive position from which to do this. We have a healthy balance sheet, we are generating cash, and our product sales are poised to continue growth for many years to come. As a result, we have the luxury of being able to remain patient and disciplined as we pursue new opportunities. While we certainly don't need to complete any transactions in order for the company to be successful, we do see opportunities to earn very attractive returns by putting money to work in commercial rare disease products that are a strong strategic fit. We are actively engaged in discussions on multiple opportunities and remain optimistic about our ability to land another product before year-end.

We remain focused on commercial assets that can immediately deliver revenue and earnings to the company. In addition to the excess cash on our balance sheet, we believe we have significant additional capital available to us should we need it. Given our current stock price relative to our near and long-term expectations for the business, our strong preference would be to utilize debt for any larger transactions. As we wrap up the call, I hope my remarks have made it clear why I'm excited about Eton's prospects over the coming quarters. We are rapidly nearing a critical inflection point, and I believe our future will be very bright as we execute on our three-pillar growth strategy. First, grow our existing products. These products are firing on all cylinders, as you saw with our record product sales for the quarter and 40% year-over-year growth.

We expect growth to continue for the foreseeable future. Secondly, our late-stage pipeline candidates are set up to produce significant additional long-term revenue growth, starting with the major launch of ET-400 in early 2025, followed closely by the anticipated approval of ET-600 less than a year afterwards. Thirdly, we remain optimistic about our prospects to acquire new products through business development, which could turbocharge our growth and provide a major boost to our profitability. With the combination of these three levers, I believe we have a great opportunity to achieve our goal of reaching $100 million in revenue in the coming years. With that, I'll turn it over to James, our Chief Financial Officer, to discuss the financials. James?

James Gruber (CFO)

Thank you, Sean. Our second quarter revenue was $9.1 million, compared to $12.0 million in the second quarter of 2023. The prior year period included $5.5 million of one-time licensing revenue related to the divestment of our neurology product royalties. Net product sales and royalty revenues for the second quarter of 2024 increased 40% to $9.1 million, compared to $6.5 million in the prior year period, which included $0.6 million of non-recurring royalty revenue. The second quarter product sales increase was driven primarily by growth in Alkindi Sprinkle and Carglumic Acid. Product sales also grew $1.1 million or 14% compared to the first quarter of 2024. As Sean mentioned, we expect product sales to continue growing quarter-over-quarter throughout the rest of this year and beyond.

R&D expenses for the quarter were $3.0 million, compared with $1.1 million in the prior year, with the increase due to the payment of a $2.0 million one-time NDA submission fee for ET-400. Absent of any new business development transactions, we expect R&D expense to return to its recent historic levels in the second half of the year. General and administrative expenses for the quarter were $5.6 million, compared with $4.7 million in the prior year period, due primarily to increased sales and marketing expenses related to the PKU GOLIKE commercial launch, as well as one-time legal fees associated with ongoing M&A activities.

Total company net loss was $2.9 million for the quarter, which includes the $2.0 million ET-400 filing fee, compared to net income of $4.6 million in the prior year period, which included the $5.5 million royalty sale to Azurity. Net loss per basic and diluted share during the quarter was $0.11, compared to net income per basic and diluted share of $0.18 in the prior year period. Eton finished the second quarter with $17.7 million of cash on hand and generated $1.3 million of operating cash during the quarter. We remain confident that our cash position is sufficient to allow us to execute our plan and continue pursuing bolt-on transactions and new product developments. This concludes our remarks on second quarter results, and with that, we'll turn it over to the operator for Q&A.

Operator (participant)

Thank you. One moment while we compile the Q&A roster. Your first question comes from the line of Chase Knickerbocker of Craig-Hallum. Chase, please go ahead.

Chase Knickerbocker (Analyst)

Good afternoon, guys. Thanks for taking the time. First, maybe on GOLIKE, maybe just talk to how the reception's been kind of relative to your expectations, when you bought it, now that you've, you know, relaunched it and interacted with a lot of your physicians.

David Krempa (Chief Business Officer)

Sure. Hey, Chase, this is David. We've got a very good reception since we acquired the product. You know, it was not promoted for a number of months before we acquired it, so the launch trajectory had lost a little bit of momentum. But we started promoting it in April at a number of conferences and have been meeting with physicians face-to-face, and they've been very excited to see the support behind the product again. And we've already seen an uptake in the number of referrals that we get off the product. So we're still very excited about the product. We still hope to capture 10% of that $100 million market. It's just gonna take us a little bit to get back on a strong growth trajectory, given that it wasn't promoted for a number of months before we took over.

Chase Knickerbocker (Analyst)

Got it. Maybe on Carglumic next. It seems like every kind of quarter, and we're talking about, you know, kind of another couple patients that we've added. Maybe just speak to discontinuations, any potential discontinuations. And then, so are these, you know, basically asked another way, are we net adding patients and you expect to have a decent number of patients, you know, growing through the year on Carglumic?

James Gruber (CFO)

Chase, hi, it's Sean. Yeah, we have been pleasantly surprised by Carglumic's performance. We continue to add additional patients. We just added two more patients recently, and it looks like we're gonna be adding more, you know, month-over-month. So I'm continuously pleased with the product, and you know, once we think we sort of have reached our max, patients seem to like our room temperature version of Carglumic acid better than the brand, and I wouldn't be surprised if that revenue continues to grow.

Chase Knickerbocker (Analyst)

Is it that difference that you think is driving it, or is there may be some additional patients out there that, you know, we maybe didn't think of before? Or just kinda talk to-

James Gruber (CFO)

I think-

Chase Knickerbocker (Analyst)

What's different versus expectations.

James Gruber (CFO)

Yeah, that's certainly part of it, is the ease of the product, the longer shelf life after opening and the room temperature improvement over the brand product. But, probably more importantly is that, many of the new patients go on our product, so we're getting a lot of younger patients. What we're seeing is that, you know, our detailing, our services, our patient care, Eton Cares program has had a big impact. We find that the doctors enjoy working with the company, and that, it's, we try to make it easy for them and so that there aren't a lot of hurdles, to writing prescriptions.

Chase Knickerbocker (Analyst)

Got it. And, maybe James, on gross margins, appreciate the commentary on, you know, kind of the strength with Alkindi in the quarter. Gross margins were a little bit down sequentially. Can you just speak to kind of the drivers there? And then on cash flow positive in the quarter, can you speak to kind of the working capital benefit that you had, and then how you kind of see that playing out in the back half of the year from a cash flow from operations perspective and kind of EBITDA? Thanks.

James Gruber (CFO)

Sure. You know, margin, gross margin profile, a real slight decrease in the second quarter. I don't think it's anything more than, you know, product mix, just given the, the very different profiles that Alkindi and Carglumic Acid have. We do expect, you know, at least consistent, if not, slightly improved profile as we move forward, as Alkindi makes up a larger percentage of overall revenue. From a working capital standpoint, you know, absent that $2 million filing fee for ET-400, you know, we, we turned cash flow positive from an operating standpoint in the second half of last year.

Definitely expect that to continue, you know, even amidst, you know, timing changes and with some sales rebates and discounts, things like that, we should firmly be in positive operating cash flow for the rest of 2024, and moving toward GAAP income profitability as well.

Chase Knickerbocker (Analyst)

... Got it. Thanks. And then maybe just a little bit of color on the ET-600 trial. Is it a pretty kind of straightforward, pivotal PK? Anything you'd call out specifically around the trial that makes it a little bit more complex, or is it fairly straightforward from a lot of trials that you've ran in the past?

Sean Brynjelsen (CEO)

Hi, Chase, this is Sean. So the trial is a repeat of our pilot study, which passed with flying colors. I don't expect any difference from the pilot study to the pivotal study. The main difference in the design is the number of patients, so that if you run a pilot and you run a fair number of patients, which we did, we don't expect that to be statistically different on the pivotal study, because it was, you know, spot on in terms of the results. I think that may be the gating item because in terms of filing it, but we expect that to be filed in the first quarter of 2025. And it's an exciting product.

It's a product that was a request from doctors, and we did some market research with patients as well. I think it will be very successful, and it will be a great launch for us in 2026.

Chase Knickerbocker (Analyst)

Got it. And, as we kind of think about commercial preparations before potential ET-400 launch, have you given any thought to any additional resources in the sales force, any additional heads there? And then how soon after a potential approval at the end of February, would you expect to launch the drug?

Sean Brynjelsen (CEO)

So we are currently happy with the size of our sales force. We have 12 reps. We are open to adding additional reps for the ET-400 launch. I don't know that it will be necessary. That's something that we'll decide. If it is necessary, it would be kind of in the 2-4 range, but at the moment, we have pretty good coverage in pediatric endocrinology. So the launch itself really should happen shortly after approval. So let's say we get approval on February 28th, we will already have batches produced. We are producing commercial batches this year. They will be tested and released and ready. The only thing that would delay us from launching on February 28th is the labeling of the product.

Normally, the FDA provides the labeling as the last step, and you typically need 3-4 weeks to print the new labeling and then package the product. So I would expect the launch to happen, let's just say April, to play it on the safe side. It could potentially be March, but we'll say April.

Chase Knickerbocker (Analyst)

Got it. And then just on BD, Sean, maybe speak to kind of, you know, the materiality of some of these deals we're pursuing and kind of how you're thinking about a potential, you know, fairly large transformative transaction for the company, you know, potentially by the end of the year. Just kind of some general, more in-depth thoughts there. And then just last for James, speak to kind of SG&A cadence through the back half of the year here, James. You know, kind of some interesting seasonality last year. Kind of speak to how we should be modeling that in the back half.

Sean Brynjelsen (CEO)

So, on the BD side, we are pursuing deals where, for late-stage products, ideally commercial products, we do have those in progress for anything that would give us $10 million or more in additional revenue, literally right out of the gate. So the size of the deal could be in the $20-$30 million range. You know, we could do obviously some smaller deals, but our focus really is on $10 million and above. At this point, as we've been growing our revenue, our need to do smaller transactions has lessened, and it's really about the pivotal deals that are more meaningful. It doesn't really take a lot more work to do a larger deal versus a smaller deal, so that's where our focus is.

We are expecting to add 1-2 commercial products before the end of the year. And, you know, we're not that far to the end of the year, believe it or not. So I, I think, that says a lot about perhaps where we are in our discussions.

James Gruber (CFO)

And then Chase, from an SG&A standpoint, Q2 did have a handful of one-time items, namely some legal consulting expenses related to ongoing M&A activity. As far as second half of the year, we would expect it to fall back to more like Q1 levels. Year-over-year, to your point, an uptick from 2023. The one big driver there is just with the commercial launch of GoLike, Eton's commercial launch, there's a decent amount of commercial resource in this initial year. So that's really the one kind of year-over-year item. You know, but it's not gonna significantly change that run rate. So I would look more like Q1 for the rest of the year.

Chase Knickerbocker (Analyst)

Got it. Thanks, and congrats on the progress, guys.

Sean Brynjelsen (CEO)

Thank you. Thank you, Chase.

Operator (participant)

I am showing no further questions. Thank you for your participation in today's call. This does conclude the program. You may now disconnect.