Heron Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the Heron Therapeutics Q1 2025 conference call. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. I would now like to hand the conference over to your speaker today. Melissa Jarrell, Executive Director of Legal at Heron.

Thank you, operator, and good morning, everyone. Thank you for joining us on the Heron Therapeutics conference call this morning to discuss the company's financial results for the quarter ended March 31st, 2025. With me today from Heron are Craig Collard, Chief Executive Officer, Ira Duarte, Executive Vice President, Chief Financial Officer, Bill Forbes, Executive Vice President, Chief Development Officer, and Kevin Werner, Senior Vice President, Medical Affairs Strategy and Engagement. For those of you participating via conference call, slides are made available via webcast and can also be accessed via the Investor Relations page of our website following the conclusion of today's call. Before we begin, let me quickly remind you that during the course of this conference call, the company will make forward-looking statements. We caution you that any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the company's projections, expectations, plans, beliefs, and future performance, all which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Security Litigation Reform Act of 1995. These statements are based on judgment and analysis as of the date of this conference call. and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties associated with the forward-looking statements made in this conference call and webcast are described in the Safe Harbor Statement in today's press release and in Heron's public periodic filings with the SEC. Except as required by law, Heron assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so. And with that, I would now like to turn the call over to Craig Collard, Chief Executive Officer of Heron.

Thanks, Melissa. Good morning, everyone, and welcome to Heron Therapeutics' first quarter 2025 earnings call. Today, we are extremely excited to share our results for the first quarter of 2025. After establishing the company's financial foundation in 2024, we are now focused on targeted product growth for our two key assets, ZENERLEF and APONTE, while continuing to maintain and grow Sylvante and Sustol within clinics and select hospital accounts. With ZENERLEF's formulary status now covering approximately 19% of all orthopedic procedures and key catalysts such as our expanded label, the VAN launch, the approval of the No Pain Act, and the Crosslink Partnership, we see a clear opportunity to drive deeper adoption in a market where we already have access and the potential to expand coverage as interest grows nationwide. In 2025, we will focus on discipline execution, optimizing commercial performance, and selectively expanding the team where it directly supports high return growth opportunities. Looking at our achievements in Q1, we generated total net revenues of approximately $39 million, achieved a record quarterly adjusted EBITDA of $6.2 million, and reported net income of $2.6 million. Since joining the company in 2023, our management team has been clear in our commitment to not only reach profitability, but also to execute with consistency. In addition, we reached a settlement agreement with Mylan Pharmaceuticals regarding the Sinvanti and Aponvi products, avoiding costly litigation fees, and removing uncertainty around the outcome of the litigation. Lastly, as we continue advancing our commercial plans, hiring the right commercial leader was a key priority. We're pleased to share that Mark Hensley joined us on April 28th. Mark, who previously worked with me at Biloxis as our commercial lead, brings deep expertise from a career spent entirely in the hospital market. He is the missing piece to the puzzle as we move into this next phase of growth. Now moving on to product performance. The Oncology franchise continues to outperform our expectations, with combined net revenues from Sinvanti and Sustol reaching $28.6 million for the quarter. We have maintained market share in a highly competitive environment, and we believe these products will continue to deliver consistent performance throughout 2025. We are extremely pleased with the results of our oncology supportive care franchise, and we are actively exploring creative strategies to drive continued growth in this market. Sinvanti, our lead product for chemotherapy-induced nausea and vomiting, or CINV, continues its strong growth. While I spoke earlier about the overall oncology franchise, you can see on the left side of this slide that Sinvanti is steadily increasing in average daily units, even within a highly competitive market. Now that the company is commercializing Sinvanti through a more focused account team across our entire portfolio, we are seeing positive results. New accounts shown in green on the graph and defined as those who have ordered within the past three months are growing at a healthy rate and benefited from the IV bag shortage in October of last year, as reflected in the spike on the graph. Existing accounts depicted by the blue line and defined as those with continuous product orders are also experiencing steady growth since the new management team joined in April of 2023. Synvonte's well-established safety profile and competitive advantages, such as the IV push administration, support its continued upward trajectory and unit growth. The key to sustaining consistency with this product will be the strategic management of our average selling price, or ASP. Now moving on to the acute hospital side of our business. Both Aponvi and Zenerlef experienced significant growth in Q1 of 2025, up over 432% and 60% respectively compared to the same period last year. We believe these two products have significant growth opportunity. Building on our efforts to strengthen our financial foundation last year, including a significant cost restructuring and the completion of numerous strategic initiatives, the full focus of the organization will emphasize product growth and execution this year. Today, the company is well-positioned for sustainable, scalable, and capital-efficient growth. With UponV, we are beginning to see a dramatic shift in key trends, particularly in average daily units and the number of ordering accounts. We believe this growth will continue throughout 2025 and beyond as our pull-through efforts drive expanded product adoption within hospital institutions. Our goal with UponV is to continue building awareness, focusing our message on its strong safety profile and unique mechanism of action. Postoperative nausea and vomiting, or PONV, is a serious issue that can often be mitigated by the addition of a PONV as the provider's third agent of choice in a multimodal approach to PONV therapy for moderate to severe cases. A similar positive trend is emerging with ZENRLEF. Our daily unit sales are steadily increasing, and we are onboarding new accounts at a much faster rate than in the past. With the VAN launch just getting underway and the Crosslink partnership fully integrated, we believe ZENERLEF is positioned to show a significantly stronger growth trajectory as we approach Q3 and beyond. Many of the current initiatives around ZENERLEF are already in motion, but require time to take full effect. As both daily unit volumes and the number of ordering accounts continue to rise, we remain confident in ZMLF's multi-hundred million dollar potential, provided we can continue to improve execution and expand usage within our existing access points. Our top priority for 2025 is discipline execution, converting access into sustained case-level market share, optimizing our current commercial footprint, and selectively investing in team expansion where it directly supports high return growth opportunities. I will now turn the call over to Ira Duarte, our CFO, to cover our financials and update our financial guidance. Go ahead, Ira.

Thank you, Craig. Our product gross profit for the three months ended March 31, 2025, was $30.4 million, or 78%, which increased from 76% for the same period in 2024. This is due to a lower cost per unit in the three months ended March 31st, 2025 as a result of production efficiencies compared to the same period ended March 31st, 2024, offset by an increase in the units sold. SG&A expenses for the three months ended March 31st, 2025 were $25 million compared to $26.4 million in the same period in 2024. The decrease was primarily related to decreases in personnel and related costs and legal expense related to the timing of patent litigation, offset by increased sales and marketing spend to support revenue growth. Research and development expenses were $2.3 million for the three months ended March 31st, 2025, compared to $4.6 million in the comparable period in 2024. The decrease was primarily related to decreases in personnel and related costs due to the terminations in 2024, as well as decrease in development activities. We achieved net income for the three months ended March 31st, 2025 of $2.6 million. During the comparable period in 2024, we had a net loss of $3.2 million. Cash and short-term investments at March 31st, 2025 was $50.7 million. If we had excluded depreciation and stock-based compensation, our adjusted EBITDA results would have been a positive $6.2 million operating income compared to a loss of $0.7 million for the same period in 2024. We are revising our previously given guidance for adjusted EBITDA range of $0 to $8 million to a range of $4 million to $12 million. And now we would like to open the call for any questions.

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment for questions. Our first question comes from Clara Dong with Jefferies. You may proceed.

Hey, guys. Congrats on the great quarter. So, my question is on the CIMANTE litigation settlements. To understand, you might not be able to share details of terms quantitatively. So, I'm wondering whether you can give any qualitative comments, and how should we think about the implications of settlement for maybe your near-term financials or guidance? Thank you. And I have a follow-up also.

to not only continue with Symbionti, but also to grow up Pondi.

Got it. And based on what you've seen so far with, after Zin-La-Raf then launched No-Ping Act taking effect in April and continued crossing partnerships, so how should we think about, or what should we expect in terms of sales momentum in the back half of the year?

Yeah, no, that's a great question, because when you look at sort of Q4 to Q1, and net revenues were fairly similar. But if you look at demand, we were actually up 2% in unit demand, and the market was actually down 5.3%. And so what we foresee in front of us, we've got a number of accounts. Actually, I think there's six accounts right now that we're in the onboarding process, meaning they've gone through P&T, and we're now getting to training physicians and training the hospital and getting things in Epic system and so forth. And this just takes time. And so one of the things that we're extremely excited about are bringing these accounts on board. And so for us, we can sort of see this coming. And, you know, if you think about all the things that are moving as far as moving pieces right now with the Crosslink partnership and, you know, just our messaging and, you know, really getting this to hit on all cylinders, we see this all kind of coming together mid-year and beyond. And so I feel extremely confident that you're going to really see a different inflection as we move towards the end of the year, and we feel very comfortable with consensus numbers and hitting those as we move forward.

Got it. Thank you, and congrats again.

Thanks, Claire. Thank you. Our next question comes from Serge Berlinger with Needham. You may proceed.

Hey, good morning. Thanks for taking my questions. The first one, Craig, can you just talk about the overall 1Q trends, whether the usual seasonality was what you were expecting or similar to prior years? And then maybe just secondly for Ira, just highlight some of the changes to the guidance and what's driving the EBITDA increase. Thanks.

Thanks, Serge. And great question again. I thought the trends were fairly consistent with what we've seen in the past. You know, whether it's copay resets or deductibles, what have you, you typically see a little bit of a fall off in Q1. But again, we were pleased because with all the other things going on, we were actually up versus the market. So I think it's a positive sign. But again, you know, we have much bigger hopes than, you know, growing 2% versus the market. And so I think as we move forward, again, as I said, you know, before to Claire's point, I think there's a lot coming at the end of the year with, you know, the number of accounts we have coming on board and really just, you know, getting this Crosslink partnership where it's really just, you know, functioning and going, just continue to become more efficient, I guess. And one of the things, too, that we're looking to do is that as we're onboarding a number of these accounts, we're looking to do a little bit more of a targeted expansion, as I said in my, you know, paragraph marks. And what I mean by that is that as we onboard these accounts, from time to time, we have gaps as far as being able to do this as fast as we want, and we may need more coverage in a certain account based on sort of the cross-link overlay of their footprint. And so we are going to expand in some areas like that. It may be headcounts such as an MSL, medical sales liaison. It may be some kind of clinical support staff or even a sales rep. And so We're really taking a much more of a targeted approach versus just an all out expansion. And we're going to do that where we have access and where things are going well as far as a new account coming on board and so forth. So that's why we're really upbeat about what we see and what's coming towards the end of the year. So I'll turn it over here on the other question.

Yeah, as far as EBITDA, hi, Serge. Thanks for the question. EBITDA, we obviously had a very strong first quarter And some of that is due to efficiencies on the overall spend. Some of that is on the announcement for the settlement, you know, the future spend on that. So overall, we feel very comfortable that the rest of the year will be fairly positive and have revised guidance on that.

Thank you. Thank you. And as a reminder, to ask a question, please press star 1-1 on your telephone. Our next question comes from Carl Burns with... Northland Capital Markets, you may proceed.

Thanks for the question, and congratulations on the results and the progress. It looks like the gross profit margin came in around 78.3%. I'm wondering if you can talk a little bit about how you expect that to progress through the balance of the year or if there was any anomalies. Obviously, the symbiotic sales were higher than expected, which should be part of it. Thanks. And then I have a follow-up as well.

Okay, thanks, Carl. Yeah, gross margin was a little higher than typical. I mean, we've said all along we thought we would be in sort of this sort of low to mid-70s, and basically what you had happen is exactly what you said. Some anti-sales were up, and we're actually, we've got two different manufacturers, and we're still using the manufacturer we have higher scale or larger scale, and so most of those lots came through there. As we go through the year, you're going to see us incorporate some of the lots from where we have a smaller scale. And so that may come down a little bit, but again, we still should be in that sort of mid seventies range.

Got it. Thanks. And then switching gears to upon the, um, you know, as a third light agent agent, um, obviously the sales there again, higher than expected. Um, how do you see it progressing and what do you see as sort of near-term long-term potential in terms of peak sales? That's obviously referencing long-term. Thanks.

Yeah, no, you know, it's Ponvi. We get so caught up sometimes, I think, talking about Zenerilev, but Ponvi is a product that once we go into a hospital system, we really don't lose these accounts. I mean, it's a product that works extremely well. It's extremely safe. And, you know, we continue to have good experiences with that. But the issue we've had is that we're getting a lot of formulary wins and, you know, and P&T wins. So we're getting access But typically where a plan B starts is sort of like a bariatric surgery or something like that. And then, you know, what you see happen as they get more usage of the product, you typically see it sort of, you know, broaden out throughout the hospital. This is where we're trying to focus now. And this is sort of a twofold problem because as we have said all along is the more we can integrate our Crosslink partnership, it allows our reps to get out of the OR, you know, cases and get out in the hospital and do more selling. And so as they're doing that, that should affect the upon-be pull-through. So you can imagine if I've got access, you know, with bariatric surgery, and now my reps are able to go into the PACU and speak to some of those, you know, nurses and so forth and talk to anesthesiology, we can get more pull-through and get sort of this system-wide usage with upon-be. And so, listen, I think upon-be is going to continue to grow. We've got, you know, a very unique safety profile and a unique MOA. And our real goal with this is to be the first choice when you go to a third-line agent. And if that happens, this is a multi-hundred million dollar drug because, you know, there's 70 million surgeries a year that occur in the U.S. And so about half of that market is, you know, moderate to severe, which is sort of our sweet spot as far as patients go. And so, again, we think we're going to continue to see tremendous growth. And I think it's only going to get better as we get better with our Crosslink partners and move our reps out of the, you know, kind of the OR suite.

Great.

Thanks.

That's very helpful. Switching back to Zimberlab, considering the formulary wins and new accounts coming on, and obviously you have a feel for the timing of that, how do you see an inflection or the timing of an inflection where Zimberlab, you start achieving sequential revenue growth? Again, I know you mentioned 2% unit growth versus the market being down, and that may be somewhat related to deductible resets and such, given the fourth quarter, first quarter transition. But I'm just wondering when you might expect to see that inflection and Zenware-led sales taking off.

Thanks. Yeah, so we know currently we have five new accounts that I think are in Michigan, North Carolina, and a couple other states that are ready to onboard. And, you know, these accounts alone are, you know, numerous amount of surgeries, not only in ortho, but obviously throughout the hospital. They're also aligned with our Crosslink partnership. So our footprints overlap with this and we have access. So look, we know that those counts are in the process of onboarding. This should take place, you know, kind of June, July, as far as getting these things fully on board. So, you know, where I really see the product beginning to change is as we move into kind of, you know, later into Q3 into Q4, I think you're going to see a really different inflection, especially as we come out of the year into 26. And so Not only do I think we'll hit consensus this year with our numbers, but I really think next, you know, as we move into next year, as these accounts come on board, and again, we continue to get better with our partnership with Crosslink, I think this is really going to change the direction of this product.

Great. Excellent. And again, congratulations on the progress and results. Thanks.

Thanks, Carl.

Thank you. I would now like to turn the call back over to Craig Collard for any closing remarks.

So I just would like to thank all the employees at Heron. We had a great quarter, and we continue to execute as we move forward. And we want to thank everyone for being on the call today, and we'll see you next quarter.

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.