Heron Therapeutics - Q1 2023
May 11, 2023
Transcript
Operator (participant)
Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q1 2023 earnings conference call. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Heron's future expectations, plans, prospects, corporate strategy, and performance, which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in Heron's filings with the SEC. In addition, any forward-looking statements represent Heron's views only as of the date of this webcast and should not be relied upon as representing Heron's views as of any subsequent date. Heron specifically disclaims any obligations to update such statements. Now I'll turn the call over to Craig.
Craig Collard (CEO)
Thank you, operator. Good afternoon, everyone, and welcome to the Heron Therapeutics first quarter 2023 earnings call. I'm Craig Collard, the new CEO of Heron Therapeutics, and I'm thrilled to be leading this organization as we continue to make headway in the hospital and oncology markets. Today, I'll provide an overview of our recent performance, highlight key achievements, but more importantly, give some insight into my assessment of the business in my first four weeks and discuss our strategic vision moving forward. Total product net revenues for the first quarter were $29.6 million up from $23.5 million in the same quarter last year, an increase of over 26%.
We continue to make steady progress on the oncology side of our business, but we remain excited about the market opportunity for both ZYNRELEF and our newly approved product, APONVIE, which was launched in March of this year. Starting with ZYNRELEF, I realize the product has had a slow uptake since launch for a variety of reasons. Despite competing in a huge market, the product has a differentiated clinical profile that works well when used. The label has limited our ability to be the drug of choice across a variety of indications. To counter that, we filed an sNDA with an October 23rd PDUFA date that, if approved, will expand our indications and number of procedures we can treat. The viscous nature of our product has slowed the withdrawal from the vial compared to other drugs.
To improve the handling, we recently started multiple enhancement programs to address some of the issues we have faced in the surgery suite during preparation, including a vial access needle or VAN and ultimately a prefilled syringe that could be game changing. Since joining the company, I've been able to get in the field and work with our sales representatives, which I always find helpful when trying to assess product performance issues. I'm happy to report that so far I have seen ZYNRELEF used in five knee surgeries. I was trying to understand what really happens in the application of the product. Previously, I'd heard mixed messages about the time to draw the product out of the vial, product viscosity, and general issues that would make it more difficult to use our product.
What I determined from watching these surgeries is that we can replicate the success I saw on this day. The application requires training the staff as it is different but not complex. The nursing staff even admitted that after using the product a few times, it became second nature and is now just part of the normal routine and prep before the surgeon arrives. I think early in the launch of the product, our company did not address this issue head on and didn't understand that this was going to require more training of our reps and highlighted our own inefficiencies. All products generally have challenges when launched, and the companies that are prepared and they can move quickly are generally the companies that ultimately succeed. The good part here is that it's not too late to get this launch back on track. Now moving to APONVIE.
The product was launched a month prior to my joining the company. APONVIE, an injectable emulsion, is the only IV substance NK1 receptor antagonist indicated for postoperative nausea and vomiting. As with ZYNRELEF, this is a product with a great clinical profile and marketing advantages and competes in a very large market. We believe that APONVIE will be a very successful product in our portfolio and has great call point overlap with ZYNRELEF. While the receptivity to the initial launch is encouraging, we will look for ways to maximize this potential and update our shareholders as we progress throughout this year. Before turning the call over to David for a financial review, I thought it might be helpful to give some insight into the business as a whole and a view into the strategic direction as we move forward.
Since joining the company, I have spent much of my time trying to understand each department, headcount, spend, and how the company functions as a unit. The goal has been to do a thorough internal review to determine the company's business practices and strategies to develop a long-term plan that allows the company to maximize value for all shareholders. Although my review is not complete, I can tell you that I have a much better understanding of the company and many changes will be coming soon, including a reduction of cash burn, an improvement of operational efficiency, and the implementation of a realistic product forecast to more accurately determine our capital requirements moving forward. Shortly after I joined the company, I implemented the first major change, which was to flatten the executive reporting structure in the company.
I hired Jason Grillot, whom I have worked with in the past, to lead our sales and marketing efforts. Jason will be improving many things with the commercial structure, including targeting, alignment, account team support, marketing message, and data to the sales force and management reporting. I believe these changes and many others to be updated later will continue to improve the uptake of our products. Other expense cuts we'll be implementing include less outsourcing and dependency on consultants and a reduction in headcount. I will provide more detail in the near future. As you know, I've been assessing all aspects of our business to ensure we are well-positioned for the future. I recognize that this process may be causing some uncertainty and concern among our shareholders. We are committed to providing you with as much information as possible about the strategic direction changes that will be coming.
We understand that you've invested your time and resources in our company. We value your input and support. We want to keep you informed every step of the way as we navigate this process. We plan to share more details with you soon about the changes we will implement and the reasons behind them. Our goal is to create a stronger, more sustainable company that is better equipped to meet the needs of our customers and stakeholders. I appreciate your patience and understanding as we work through this process. We are confident that our changes will position us for long-term success. We look forward to sharing more information with you soon. Go ahead, David.
Speaker 7
Thank you, Craig. As Craig mentioned in his remarks, our net product sales for the first quarter of 2023 were $29.6 million, compared with $23.5 million in the first quarter of 2022, representing an increase of 26% over the same period in 2022. For the first quarter of 2023, our ZYNRELEF net product sales were $3.5 million. In March 2023, APONVIE became commercially available in the U.S. For the first quarter of 2023, APONVIE net product sales were $244,000. Our Oncology Care franchise net product sales for the first quarter were $25.8 million, which was an increase of 15% over the same quarter in the prior year.
For the full year of 2023, we expect Oncology Care franchise net product sales of $99 million-$103 million. Cost of product sales for the first quarter of 2023 were $16.9 million, compared to $11.4 million for the same period in 2022. For Q1, 2023, cost of product sales included a one-time charge of $5.3 million, resulting primarily from the write-off of short-dated ZYNRELEF inventory. Research and development expense decreased from $42.1 million in Q1, 2022 to $13.8 million for the first quarter of 2023, primarily due to a decrease in external development costs related to ZYNRELEF.
Our sales and marketing expense decreased slightly from $23.4 million in Q1 2022 to $21.2 million for the first quarter of 2023, primarily due to a decrease in costs to support the ongoing commercialization of ZYNRELEF. We are reporting a loss from operations of $33.1 million for the first quarter of 2023, which compares to an operating loss of $62.9 million for Q1 2022. Our balance sheet at the end of March 2023 shows a cash balance of $60 million, down from $84.9 million at the end of December 2022. Craig, back to you.
Craig Collard (CEO)
Thanks, David. Operator, we'd now like to open things up for questions. Go ahead, please.
Operator (participant)
At this time, if you would like to ask a question, simply press star followed by the number one on your telephone keypad. Our first question will come from the line of Brandon Golas with Cantor Fitzgerald. Please go ahead.
Brandon Golas (Analyst)
Hi, thanks for taking my questions, Craig, congratulations on the appointment. Maybe just firstly from me, just how quickly do you think we can see a return on the training of staff? Secondly, I know it's early stage, and we perhaps need to be a bit patient here, but any more granularity in terms of going broader and deeper into these accounts and sort of maybe some of the specifics that you think you can do to change the trajectory of ZYNRELEF? Lastly, you know, maybe just any color, and I know sort of this wasn't given during your time, Craig, but I think we were looking for 10% volume growth in 1Q 2023 over 4Q 2022, when we report our year-end earnings. Just any color, did that volume growth materialize?
Were there any movements on price? Just any color there on ZYNRELEF. Thank you very much.
Craig Collard (CEO)
Thank you, Brandon. I would, I guess, just start by saying that, as you know, we're in cash preservation mode, and what we're really trying to do is to, you know, optimally have optimization of our resources. You know, regarding stock price and that type of thing, I believe that, again, with proper management and beginning to see consistent quarters and growth of our product, I think again, that should affect the stock price longer term. I think in the short term, again, keep in mind I was not here for this quarter that I'm speaking of. You know, growth of products and that type of thing and depth in the accounts and what happened this prior quarter, I can't really speak to other than just to speak to where we are.
Again, getting back to, you know, our goal is to get this company to profitability as soon as we can. We're gonna give a lot more detail around that, and that really includes minimizing our spend, you know, being a bit more of a leaner organization and then really maximizing our efficiency in sales. Speaking specifically, you know, to ZYNRELEF and getting deeper into accounts and that type of thing, I agree. I think where we have usage, we can certainly get deeper into those accounts. I spoke a little bit about. You know, the day I was in the field, and, you know, the thing that I left with that day really was I'm looking for things we can standardize.
You know, one thing that one person does in account, can you really carry that across, all the sales people that we have and, you know, and create something that can be replicated? When I saw that day that, you know, we can, I think the application issues that I'd seen and heard about, again with the proper prep and training, as I'd said, it really does go away. When the surgeon walked in to, you know, do the knee surgery that day, it was literally invisible to that person. The product was on the in the field, in the sterile field, if you will. They used it.
One of the things that they actually mentioned that I thought was very interesting 'cause we talk a lot about viscosity, the surgeon mentioned to me that I really like the viscosity. He actually called the product honey. He said, "I really like the viscosity of this product 'cause it stays where I put it." Again, I think in some ways we sort of ran from that, but I think we should be running towards it. I really do think the product is very underoptimized and again, the good news is the product works, and it works well.
Brandon Golas (Analyst)
Great. Thank you very much for taking my questions.
Craig Collard (CEO)
You're welcome.
Operator (participant)
Your next question will come from the line of Boris Peaker with TD Cowen. Please go ahead.
Speaker 6
Hi, this is Nick on for Boris. Thanks for taking our question. Just quickly on APONVIE. How are you thinking about marketing this moving forward? I know that you mentioned that there are a lot of similarities between, like, the calls that you'll make with APONVIE and ZYNRELEF. I was just thinking about, like, separately, how would you be planning to market this to potentially have a faster growth than ZYNRELEF did?
Craig Collard (CEO)
Yeah, no, it's a great question. I mean, one of the things I was sort of faced with when I walked into the company was, you know, where do you put your resources? Do you continue to pour more resources towards ZYNRELEF or do you move things a little bit more towards APONVIE? I think right now, as I walked in the door, we were a little more weighted towards ZYNRELEF. If you think about it, you know, ZYNRELEF is a trickier sell. There's a little bit more time and effort that goes on with the surgeon and in the surgery suite. APONVIE is a little bit different. It's almost like an annuity. In a sense, if you're getting formula...
If you can break through P&T and get on formulary, you almost get a bit of a protocol scenario, where you're in the Epic system and you're being used all the time. From my perspective, APONVIE is a much easier sell. Now again, how it's been reacted by customers and all that I just haven't had a chance to really see a lot of that yet. As part of this sort of plan, as I talked about, you know, communicating more going forward, we're looking at that and we're looking to put additional resources behind APONVIE. The really interesting thing that I've seen from the marketing data thus far on APONVIE, though, is that the oral prep agent market is growing with literally no promotion and that's generally unheard of.
The takeaway from that is, you know, hospitals and physicians and anesthesiologists like this product, and it's growing without literally any promotion. If I look at that and then I look at the, you know, the massive size of the ondansetron market and really just look at patients that are dosed again with the same product, if we could just capture those two markets, I mean, this is a multi-hundred million dollar drug. From that perspective, it really does intrigue you of, you know, what we can actually do with that product. Again, we're looking at it now, and trying to, you know, sort of really look at not only how we comp our reps, but the alignment of our sales force and all that.
I think all that is up in the air at this point but we'll have some decisions here pretty quickly.
Speaker 6
Great. Thanks for that. For the VAN and pre-filled syringe, what are the next steps to get them approved, and when do you expect this to be done for each of them?
Craig Collard (CEO)
I'm sorry, did you say pre-filled syringe?
Speaker 6
The VAN as well.
Craig Collard (CEO)
Yeah.
Speaker 6
The VAN, yeah.
Craig Collard (CEO)
We've got some initial timelines that I've looked at. I'm hoping we can be a little quicker on this, but it's. We've done some work on the pre-filled syringe. I mean, we're sort of looking at the 2026 timeframe, I think is sort of generally what I've heard, but I'm hoping we can pull that back a bit. The VAN will probably fall somewhere in between that in that timeframe. If it does work out that way, we would have, you know, the VAN coming in about a year and a half or so, and then, you know, probably a year and a half after that, you'd have the pre-filled syringe. I think in the midst of all that as well, you've also got the expansion of the label possibly with the sNDA filing.
Speaker 6
Great. Thank you very much.
Craig Collard (CEO)
You're welcome. Thank you.
Operator (participant)
Your next question will come from the line of Rohit Bhasin with Needham & Company. Please go ahead.
Rohit Bhasin (Equity Research Associate)
Hi, this is Rohit on for Serge. Thanks for taking our questions. For the CINV franchise, previous management provided prior guidance of $99 million-$103 million. Does this guidance still stand? Secondly, you mentioned reducing cash burn. Do you have any plans to pull back on the sales force? Thanks.
Craig Collard (CEO)
Yeah. On the CINV franchise first, I've seen that we've given guidance in the past, and what I can tell you is I think that the CINV franchise is moving along quite nicely and is fairly steady. What I didn't like when I initially saw that, just being perfectly honest, I haven't been involved in a company that gave partial guidance on partial products. What I would prefer to do as we get our hands around this, is give guidance a little more from a company standpoint and less about, you know, a particular product. That's sort of the reasoning, and that was my decision. But I can tell you that things are moving, you know, along fairly steadily. I'm trying to think of your other part of your question.
Rohit Bhasin (Equity Research Associate)
Yeah. You mentioned reducing cash burn. Do you have any plans-
Craig Collard (CEO)
Oh.
Rohit Bhasin (Equity Research Associate)
to pull back on the sales force?
Craig Collard (CEO)
Yeah, I'm sorry. The sales force. We're looking at that. Again, we wanna be more efficient. It may be more of a realignment. We're certainly not doing, you know, anything on the oncology side. I think on the acute side, we're just trying to really assess, are we aligned in the proper accounts, and what does that look like? You know, would we, you know, trim that a bit in the short term? It's possible, but we're really more looking at how better to align to the, you know, whether it's APONVIE or ZYNRELEF and how we kinda go about that. It's, you know, that takes a little bit of time and, you know, Jason, like I mentioned before, was hired just a few weeks ago, and he's on top of that.
I'm hoping we can have something, a little more clear on that here very shortly.
Rohit Bhasin (Equity Research Associate)
Great. Thank you.
Craig Collard (CEO)
You're welcome.
Operator (participant)
Your next question comes from the line of Carl Byrnes with Northland. Please go ahead.
Carl Byrnes (Senior Equity Research Analyst)
Thanks for the question, and congratulations on the promotion. Considering the one-time ZYNRELEF inventory write-off, which I think was referenced at $5.3 million, if we back that out, it looks like the gross profit margin would have been around 61%. Does that sound right? Is that a number that you would expect to be sustainable and in the second, you know, going, you know, going forward in future quarters?
Craig Collard (CEO)
Yeah. Carl, it's a great question. You know, you just said something funny when you, when you congratulated me on the promotion. I'm hoping the next quarter or quarters after this, what you say is, "Hey, guys, congratulations on a great quarter." That's what we're striving for. I'd like to get that out first, I guess. Regarding gross margin, no, we're not optimally where we need to be. I would like to see us move towards, you know, under sort of a 20% COGS, which will be 80% gross margins. That's where I'd like to strive for. I think with what we're doing batch size-wise now, you're gonna see some of that being reflected. I'm also looking into every manufacturing agreement we have and seeing where we can improve upon that.
Ideally, I would like to get us down in sort of that, you know, I would call it a high teens-20% range. We're not there yet, but it was affected obviously by this one-time write-off of ZYNRELEF.
Carl Byrnes (Senior Equity Research Analyst)
Got it. Thanks.
Craig Collard (CEO)
You're welcome. Thank you.
Operator (participant)
For any questions, please press star one. Your next question comes from the line of Kelly Shi with Jefferies. Please go ahead.
Speaker 5
Hi. Thanks for taking my question. This is Clara on for Kelly. For the same accounts you're targeting for APONVIE and ZYNRELEF, what would be your strategy to maximize the synergy between those two products and how should we expect the synergy to kind of be reflected on the sales in the coming quarters? For the ZYNRELEF, for the sNDA, what are some strategies and efforts to help ZYNRELEF fully recognize the additional opportunity indicated by this additional indication? Thank you.
Craig Collard (CEO)
Yeah. No, thank you for your question. I'll start with the sNDA. Again, as you know, we've filed it with the FDA, and we have a PDUFA date. Outside of that, you know, we cannot predict, you know, what indications we will get and how broad the label that we'll ultimately receive approval of. You know, our hope obviously is that it broadens it, and we get all the indications we ask for. We just don't know that yet. It's difficult to plan, you know, until you really know what you're gonna have. There'll be more to come on that. Really with the APONVIE and ZYNRELEF, the synergy's there. I mean, if you think about it, those two products that fit really well together.
I think the question we're, you know, really struggling with right now is where do we put our resources now? Because when I look at ZYNRELEF and I think about you have a VAN coming, you've got a possible expansion of sNDA, then you have really what should be game changing because it changes the whole sterility problem is the prefilled syringe. One could argue that, you know, in this period, you know, should we focus more of our resources possibly on APONVIE, which is a much easier sell, quicker, has a bit of an annuity factor to it in a very large market. Again, I don't have specifics yet but that's what we're debating. I think we'll have answers very shortly. The good news is the products, as you mentioned, do fit well together. The call points are similar.
Again, I think, over time, you know, these products should both grow significantly. It's just a question of which one we focus on first and how we sort of do that.
Speaker 5
Very helpful. Thank you.
Craig Collard (CEO)
Okay. Thank you. You're welcome.
Operator (participant)
I will now turn the call back over to Craig for any closing remarks.
Craig Collard (CEO)
Yes. Thank you, operator. First I'd like to thank everyone, you know, for my first call here as CEO of Heron. I also really wanted to thank all the employees here. I mean, change is difficult and again, there's been a lot of things going on here and we're putting a lot of information together. I think what you're gonna see in the future is a much, much different company that again, will head towards profitability and will be a success. I'm excited about that. Again, I just wanna thank everyone here that's being a part of that thus far. We'll see you next quarter.
Operator (participant)
Ladies and gentlemen, that will conclude today's call. Thank you all for joining. You may now disconnect.