Eton Pharmaceuticals, Inc.

And welcome to the IN Pharmaceuticals First Quarter 2025 Financial Results Conference call. At this time, all participants are in the listen-only mode. Following the formal remarks, we will open the call out for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to David Kempa, Chief Business Officer at IN Pharmaceuticals. Please proceed.

Thank you, Operator. Good afternoon, everyone, and welcome to Eaton's first quarter of 2025 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, EatonPharma.com. Joining me on our call today, we have Shawn Brangelson, our CEO, James Gruber, our CFO, and Ipek Trinkas, our Chief Commercial Officer. 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 investorrelations at eatonpharma.com. 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 companies' filings with the SEC. Now, I will turn the call over to our CEO, Sean Brangelson. Thank you, David. Good afternoon, everyone, and thank you for joining us today. If you were aware with us for our Investor Day in March, you heard about Eaton's transformational 2024, and I'm proud to say the momentum has continued into 2025. Our existing products are generating strong growth We recently added two high-value commercial assets to our portfolio with the acquisition and relaunch of Incalex and Dalsim, and we've advanced our pipeline candidates, setting the stage for two potential approvals in the next nine months. We've seen now sequential growth product revenue for 17 straight quarters since the launch of Alcantara Sprinkle. Though we are very proud of this track record of commercial execution, we are just getting started. With attractive growth prospects for existing products and a strong late-stage pipeline, we expect this streak to continue well into the future, and we're very excited about what lies ahead. I'd like to begin with one of our important new products, AnchorLyx. AnchorLyx is a complex biologic product used in treating patients two years of age and older who suffer from severe primary insulin light bulb factor I deficiency, SPIGFD, affects an estimated 200 children in the United States. When we signed the transaction in the fourth quarter, we were very excited about the deal, given the strong strategic fit within pediatric endocrinology, and what we saw is a very attractive growth opportunity. We are now nearly five months into the transaction, and I am pleased to say that it is exceeding our expectations. Eaton saw a tremendous opportunity to leverage our existing pediatric endocrinology sales force and commercial infrastructure, as well as make new investments into community initiatives to raise awareness of this ultra-rare condition, which unfortunately had seen an increased number of children going undiagnosed in recent years. At its peak more than a year or decade ago, Anchor Lights had 185 patients in the United States. But that number has been declining for years, and we've had only 67 patients when we completed our acquisition late December. With the significant investments we've made, plus the hard work of our commercial team over the last five months, I am pleased to say that the trend appears to have reversed. We've now reached over 90 active patients and remain confident that we can reach our goal of 100 patients by the end of this year and even higher levels in the years to come. Missed diagnoses have been a long-standing problem with this condition. When physicians are presented with short of stature patients, an IGF-1 deficiency is not necessarily top of mind. And there's an ingrained habit of automatically prescribing growth hormones. SPIGFD patients generally have normal growth hormone levels, so this treatment is ineffective and delays a proper diagnosis, causing SPIGFD patients to miss the NCLEX treatment window. We feel that it's important for all short-stature patients to be screened for severe primary IGF-1 deficiency and are using our deep relationships in the pediatric endocrinology community to drive greater awareness of SPIGFD and push for the screening. Eaton is also working to expand access for U.S. patients by seeking to harmonize the U.S. and EU labels The definition of what constitutes severe primary IGF-1 deficiency differs between the regions. While the height criteria is consistent, the IGF level is not. In the United States, a patient's IGF level must be at least three standard deviations below the median. While in the EU, patients must be in the bottom 2.5 percentile for their age and gender, which translates to approximately two standard deviations. We have completed statistical analysis of the patient registry that has tracked hundreds of NCLEX patients over the last decade, and we believe it shows that the product is safe and effective in the slightly broader EU-labeled population. We expect to submit a supplemental filing to the FDA in the second half of 2025. By harmonizing the two definitions, we estimate that up to 1,000 U.S. patients could clinically benefit significantly expanding treatment opportunities beyond the current 200 patients. We are proud of the team's hard work to close, integrate, and relaunch INCROLEX. The growth achieved in such a short period of time is impressive, and it is clear that a long-term growth opportunity remains with or without the label of harmonization. During the quarter, we announced the out-licensing of INCROLEX's international rights to a survey of pharmaceuticals for an upfront payment of $4.3 million. NCLEX's international opportunity is relatively small, highly fragmented across more than 30 different countries, and has slim margins. In addition, the outlicensing eliminated the need for Eaton to make a multi-million dollar G&A investment to support global infrastructure, maintain foreign regulatory approvals, and facilitate commercial and distribution activities. We believe the transaction will be far more additive to Eaton's profitability than if we had commercialized the product internationally ourselves. The transaction also provided us with a $4.3 million upfront payment, recouping a meaningful portion of our initial purchase price and providing excess capital that can be reinvested into our attractive pipeline opportunities. And finally, it eliminated the distraction and resource burden that would have come with managing more than 30 territories and instead allows our team members to fully dedicate their time and attention to our three high-value U.S. product launches in 2025. A survey shares a similar philosophy of putting patients first, so we are confident that they will be a good partner for the product and ensure that the international patients have access to this meaningful therapy. Turning now to Alkindi. This has been a strong growth driver for us for 17 straight quarters with no signs of slowing down. In fact, the pace of referrals has actually increased in 2025. As you may remember, beginning in January, we made our existing sales force 100% focused on pediatric endocrinology. We believe this has driven increased efficiency, which is apparent not only in the strong launch of Infolex, but also in an increased rate of new Alkindi sprinkled prescriptions. Through April, the number of new patient referrals received this year exceeds the first four months of any other year since launch. Despite the relatively high discontinuation rate, we have still added a significant number of new patients this year and are quickly closing in on our 500 active patients. Eaton has been encouraged by Alkindi's strong start to the year. and are expecting the rate of new patient ads for adrenal insufficiency franchise to accelerate even further in the second half of 2025 with the anticipated launch of ET400. As we have discussed at length, we continue to see a large portion of the market using unapproved compounded hydrocortisone due to their preference for a liquid dosage form. We believe approximately 50% of young children are using a non-FDA liquid hydrocortisone today. With an estimated 5,000 adrenal insufficiency patients under nine years of age, we continue to see a very compelling market opportunity for ET400. ET400's producer date is just two weeks away, and we are prepared to launch quickly upon potential approval. We've manufactured our launch inventory, and our specialty sales force and promotional campaigns are ready to go live. We have been engaged in communications with the agency throughout the review, being optimistic that they will meet their Purdue Law goal date of May 28th. It's a very exciting time, Eddie. After many years of hard work, our team is very excited to be on the cusp of making this important medication available to the patients in need. Transitioning now to another significant opportunity. The treatment of Wilson's disease, or Wilson disease, more correctly, a rare genetic disorder that causes excessive copper accumulation in the body. Patients suffering from this condition do not metabolize copper normally, with their bodies absorbing the copper instead. It prevents it from leaking the body, and Galzin is an FDA-approved treatment for patients with Wilson disease who have been initially treated with a chelating agent. It is the only FDA-approved zinc therapy for Wilson disease today. As with Incolite, we were drawn to Gallatin as an acquisition because we saw significant opportunities for each to add value, grow the product, and improve outcomes for patients. And similar to severe primary IGF-1 deficiency, Wilson disease is a severely underdiagnosed condition with a lack of product investment leading to inadequate awareness and education. Wilson disease is estimated to impact approximately 10,000 people in the United States but we estimate that only 2,000 of those patients are diagnosed and actively on a therapy today. Unfortunately, most patients are not diagnosed until they are in their 20s or 30s when symptoms begin to present after years of excessive copper buildup. This delayed diagnosis leads to worse outcomes, including neurological damage and liver failure. The increased frequency of genetic testing in recent years has led to earlier diagnoses allowing patients to proactively start zinc therapy before liver or other damage occurs. But an unmet need still remains. Of the roughly 2,000 patients that have been diagnosed and are on treatment, we estimate approximately 800 use zinc therapy, while the remainder are on chelate agents. However, due to historical challenges with access, affordability, and awareness, Most patients on zinc therapy appear to be using over-the-counter supplements rather than the FDA-approved prescription product. The nutritional supplements are a different form of zinc, which have been shown to be less effective than Galzin. We acquired Galzin because we feel that we are the right company to address this dynamic. We relaunched the product in March with robust patient services, including a $0 copay. For the first time ever, every Wilson disease patient who wants Gelson can access it, regardless of insurance status. We believe Eaton Cares is one of the most generous, high-touch patient assistant programs in industry. And one of the many things that sets us apart from other rare disease companies. Our relaunch has received a warm reception from the community, including patient advocates and leading Wilson disease physicians. We are currently migrating patients to Eaton's commercial infrastructure and Eaton Cares program. This migration kicked off in March and will be a multi-month process out of the previous pharmacies' work-through inventory that remained in the channel. We expect the conversion to be largely complete by the end of the third quarter, at which time Gallatin should begin producing meaningful revenue. I'm pleased to be able to solve the access and affordability issues that have impacted gals and uses for more than a decade. However, we believe that there is more that can be done to improve the lives and outcomes of Wilson's disease patients. After access and affordability, the two most common complaints about zinc therapy are the burdensome dosing requirements and unpleasant GI side effects. We set out to tackle these challenges with the development of ET7 which we disclosed for the first time in March. ET700 is an extended release version of Galzin, which we believe will eliminate the need for three times per day dosing, as well as potentially reduce the GI side effects that are reported by some patients on zinc therapy today. We initiated ET700 development last year prior to the acquisition of Galzin and have now filed a patent on our proprietary formulations. We're now advancing this program at full speed and working with the top Wilson disease thought leaders to prepare a clinical study protocol. We are preparing for the manufacturing registration batches later this year and have a meeting with the FDA in the second quarter to discuss our proposed clinical program. If everything goes as planned, we expect to file an NDA in 2027. We believe this product candidate has the potential to generate more than 100 million in peak revenue. Our metabolic portfolio, which includes carbolic acid, betaine, antacidone, and gold light, continues to provide steady revenue and cash flow. The group of products produced a solid year-over-year growth in the first quarter, but one of reduced significance to each of them going forward due to the rapidly increasing revenue contributions from our high-margin pediatric endocrinology products. Turning now to our development pipeline. During the quarter, we were pleased to report that ET600 passed its pivotal bioequivalency study, which allowed us to submit an MDA for the product in late April. ET600 is Eaton's proprietary patent or patented full solution of desmopressin under development for the treatment of central diabetes insipidus. Leading pediatric endocrinologists have long expressed the need for this product because it allows for the small, precise, and titratable doses required to treat pediatric patients. ET600 is the same pediatric endocrinology prescriber based as LKB Sprinkle, ET400, and Incolex. This should provide an important start once commercialization activities begin. We expect our application to be assigned a 10-month review, which will allow for an approval and launch potentially as early as the first quarter of 2026. Pre-launch commercial activities are already underway, and we are excited about the prospects for this important product. Eaton is also continuing to advance Amplivia, which we acquired late last year. Amplivia is designed for the treatment of the ultra-rare condition of neonatal diabetes mellitus, which impacts an estimated 300 children in the United States and is within our pediatric endocrinology call point. Although the product has been approved in the EU since 2018, there are currently no FDA-approved oral treatments for the condition, and therefore it is not possible for infants in the U.S. to receive the correct dose in an FDA-approved manner. Today, caregivers must either obtain a suspension from a compounding pharmacy or crush adult tablets to create a suspension at home. Similar to ET400 and ET600, Amplitia gives us an opportunity to bring a liquid formulation to the market to provide precise and accurate pediatric dosing. Our acquisition terms allowed us to have an FDA meeting to receive confirmation of the clinical pathway before any payment occurred. This meeting occurred in April, and we were pleased with how it went. The FDA was receptive to what we believe is a feasible clinical pathway to bring this critical treatment to patients in the U.S. In the first quarter, we also unveiled another new internal development program, ET800. Our French development partner, Crossjet, will continue to work on advancing the Zeneo hydrocortisone autoinjector, and separately, ETEN will manage the development of this injectable vial product, which we are calling ET800. In addition to the large retail opportunity, hydrocortisone injection, which we have discussed extensively, there was an even greater use of the hospital setting. A total of more than 5 million vials per year and approximately 100 million sales per day. Today, hospitals use a lyophilized or freeze-dried powder vial, which must be manually reconstituted prior to administration. We have developed and filed a patent on a proprietary ready-to-use liquid formulation that we believe save time, reduce risk of medical errors, and is an important factor as hypercortisone is often used in the emergency room and operating rooms. If development activities progress as planned, we expect to make registration batches in the coming months and submit an NDA in early 2027. On the business development front, we expect acquisition and licensing transactions to remain a central part term story, and we continue to evaluate new opportunities. We've demonstrated that we can successfully execute value-creating transactions, and we expect to continue to do so. However, our strong position allows us the luxury to remain disciplined and focus solely on products that are aligned with our ultra-rare-to-date strategy, and can be our high threshold for financial returns and value-creation opportunities. As you have heard today, it's a very busy time indeed. We have made great strides in our mission to bring as many new rare disease treatments to patients as possible. With two major product launches, three launches already underway this year, and the largest launch in our history potentially a matter of days away, there's never been a more exciting time for the organization. Following the expected launch of ET400, we see a clear path to reaching $100 million of revenue in the near term, and much higher levels as our pipeline products come to market. Through years of hard work, our team has built an extraordinary organization, and we continue to make progress every day toward our goal of becoming one of the leading ultra-rare disease companies in the world. With that, I'll turn it over to James, our Chief Financial Officer, to discuss the financials and to discuss the tariff questions. James? Thank you, Sean. I'll start by addressing the tariff situation in the U.S., since that seems to be at the top of everyone's list of questions right now. We believe Eaton would see minimal impact from any of the tariff proposals discussed to date. The majority of our products are produced in the U.S. Eaton does not hold any IP in any foreign countries, and we do not have any intra-company transfer price arrangements. Our primary exposure would be with Incrolux and Alkindi, which are both manufactured in Europe. The anticipated cost of products purchased from Europe represents less than 5% of our forecasted revenue. So a 20% tariff on European purchases would impact total company gross margin by less than 100 basis points. And the potential impact would likely be even smaller in future years since our late stage pipeline products ET400 and ET600 will also be manufactured within the US. In short, We are not concerned about the impact of tariffs, but we will continue to monitor the situation closely. Turning to our financial results, our first quarter revenue was $17.3 million compared to $8.0 million in the first quarter of 2024, an increase of 117%. Net sales during the quarter included $3.3 million of the licensing revenue, of which $1.8 Although Eaton is receiving $4.3 million upfront, accounting guidance results in recording $1.8 million immediately, with the remaining $2.5 million recognized over the licensing term. We also recorded $1.5 million of licensing revenue from a regulatory milestone event associated with our previous divestiture of DS-200. There was no licensing revenue recognized in the prior year quarter. Product sales were $14.0 million for the first quarter of 2025, compared with $8.0 million in the first quarter of 2024, an increase of 76%. This growth was driven primarily by increased sales of Alkindi Sprinkle and the addition of Ink Relax, which was acquired in late December. We expect product sales to continue growing quarter over quarter throughout the rest of 2025 and beyond. and we continue to expect to exit 2025 at an approximately 80 million annual revenue run rate. Gross profit for the quarter was 9.9 million, compared with 5.0 million at the prior year period, primarily due to increased product sales. Adjusted gross profit, which excludes the impact of acquired inventory step-up adjustments and intangible amortization, was 12.0 million, or 69.5% of total revenue versus 5.2 million of adjusted gross profit, or 65.6% of total revenue in the prior year period. This increase was driven by continued growth of higher margin LQB sprinkles and the recognition of higher margin licensing revenue in the first quarter of 2025. We expect to report full year 2025 adjusted gross margin of approximately 70% and long-term adjusted gross margin to exceed 75% by 2028. R&D expenses for the quarter were $1.2 million compared with $0.7 million in the prior year period, primarily due to increased expenses associated with our ET700 and ET800 project development activities. It's worth noting that in April, we paid a $2.2 million NDA application fee related to our ET600 submission. That cost will be fully recorded as R&D expense in the second quarter, and we also expect to record a $500,000 expense for an NGLEDIA licensing payment in the second quarter of 2025. Besides these two one-time items, we expect R&D spending to remain largely in line with historical levels for the remainder of 2025. General and administrative expenses for the quarter were $9.2 million compared to the $5.2 million in the prior year period. As mentioned in our fourth quarter call, increased SG&A expenses in 2025 were planned and necessary to build out the infrastructure needed to support the significant growth in our product portfolio and revenue base. These incremental investments include our new dedicated five-person metabolic sales team, which launched on January 2nd, commercial investments made in the product relaunches of INCRALEX and GALSEN, investment in our ET400 launch readiness activities, and additional corporate staff to support the growing portfolio in the areas of quality, regulatory, and finance. On an adjusted basis, which removes the impact of share-based compensation, transaction-related costs, and other one-time expenses. G&A expense was $7.3 million compared to $4.4 million in the prior year period. In addition to the planned increases in our infrastructure, SG&A expenses during the quarter were also affected by relaunch and prelaunch commercial activities in the period. We are not planning to make further significant investments in SG&A this year, and anticipate that adjusted G&A spending will remain flat or slightly decline for the remainder of 2025. We believe that the investments we've made in G&A during the quarter will support revenue levels much higher than where we are today, and as a result, we expect a return to minimal G&A growth in 2026 and beyond. Adjusted EBITDA for the first quarter of 2025 was $3.7 million, compared to 0.5 million in the first quarter of 2024. Total company net loss was 1.6 million for the quarter, compared to a net loss of 0.8 million in the prior year period. Net loss per basic and diluted share was 6 cents during the quarter, compared to net loss per basic and diluted share of 3 cents in the prior year period. On a non-GAAP basis, We reported net income of $2.4 million for the first quarter of 2025, compared to $0.2 million in the prior year period, and diluted earnings per share of $0.07 for the first quarter of 2025, compared to $0.00 in the prior year period. Eaton finished the first quarter with $17.4 million of cash on hand, and we generated $2.1 million of operating cash flow during the quarter. This concludes our remarks on first quarter results. And with that, we'll turn it over to the operator for Q&A.

Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1-1 again. Please stand by while we compile the Q&A roster. Now, first question, coming from the line of Chase Knickerbocker with Crate Harlem, your line is now open.