Q3 2024 Pacira BioSciences Inc Earnings Call
and Anthony Malloy.
Speaker Change: Good day and welcome to the third quarter 2024, Percier Biocyent's in Ernest Conference Call. At the time, all participants are no snowy mode.
Speaker Change: After the speaker's presentation, there'll be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would like to turn the call over to Susan Mesco, head of Investor Relations. Please go ahead.
Speaker Change: i
Susan Mesco: Thank you and good afternoon everyone. Welcome to today's conference call to discuss our third quarter 2020 for our financial results.
Speaker Change: Joining me are Frank Lee, Chief Executive Officer, and Sean Cross, Chief Financial Officer.
Speaker Change: Kristen Williams, Chief Administrative Officer, Lauren Riker, Senior Vice President Finance, and Jonathan Slonin, Chief Medical Officer, are also here for today's question and answer session.
Before we begin, let me remind you that this call will include forward-looking statements subject to the safe harbor provisions of federal securities law.
Speaker Change: Such statements represent our judgment as of today and may involve risks and uncertainties, which may cause our actual results, performance, or achievements to differ materially.
Speaker Change: for information concerning risk factors that could affect the company.
Speaker Change: Please refer to our filings with the SEC, which are available from the SEC or the PSIRA website.
Speaker Change: Lastly, as a reminder, we will be discussing non-GAAP financial measures on today's call. A description of these metrics, along with our reconciliation to GAAP, can be found in the news release we issued earlier this afternoon. With that, I will now turn the call over to Frank Lee.
Frank Lee: Well, thank you, Susan, and good afternoon, everyone. As you know, our top priority in 2024 is to ensure that, as an organization, we're well positioned to deliver accelerated growth in 2025 and beyond.
Speaker Change: Since our last call, we've continued to make important progress in three key areas.
Speaker Change: First, we're now aligned and committed to a refreshed, clear mission to deliver innovative, non-opioid pain therapy to transform the lives of patients.
Speaker Change: It's a straightforward, yet compelling mission that personally resonates with me and our Passero employees.
Speaker Change: Underpinning our mission are three guiding principles that we uphold every day.
Speaker Change: Keep the patient at the center, follow the science, and treat our people well.
Speaker Change: Second, we've completed a comprehensive portfolio review and defined a growth-oriented long-term plan and therapeutic area strategy focused on musculoskeletal pain and adjacencies.
Speaker Change: These are all significant and growing markets of high and met need that are poised for innovation.
Speaker Change: Our portfolio of products and expertise in this space leaves us well positioned to drive innovation and create value.
Speaker Change: Third, we've established the foundation.
Speaker Change: for a modernized, best practice commercial, market access, and medical powerhouse.
Speaker Change: In parallel, we continue to advance our commercial initiatives as we lay the groundwork for expanded expiral utilization ahead of the implementation of no-paint.
Speaker Change: As you know, this important reimbursement policy will begin providing separate outpatient reimbursement at ASP plus 6% in 2025.
Speaker Change: We've completed another round of market research among hospital C-suite and key stakeholders.
Speaker Change: similar to our original findings, awareness and understanding around no pain and its potential impact on patient care is growing among these hospital decision makers and key stakeholders.
Speaker Change: We expect it will take time for customers to implement this new reimbursement across their organizations.
Speaker Change: We're also pleased to report that Xpiril will have its own product-specific J-code, beginning in January of 2025.
Speaker Change: In addition to streamlining the reimbursement billing and coding process, a J-code is more likely to be recognized and covered by commercial payers.
Speaker Change: This combined with impending reimbursement from NoPain is particularly important to expanding expirile access across different types of care and types of payers.
Speaker Change: As you know, we're also partnering with GPOs for broad use and paved the way for no pain.
Speaker Change: Through these preferential pricing programs, healthcare systems can afford the opportunity to be at the forefront of opiates-bearing paint management.
Speaker Change: We recently launched a new partnership with Vizient, whose significant network covers approximately 30% of exprail relevant market procedures.
Speaker Change: We're on track for our third and final GPO partnership to go live at the end of this year or early next year.
Speaker Change: Thank you.
Speaker Change: This agreement will cover another 20% of the market. Once completed, more than 80% of Xperil business will be under contract.
Speaker Change: turning to Zoretta and Iovera.
Speaker Change: Both products are performing according to plan with solid third quarter sales.
Speaker Change: Our Phase 3 Registrational Study for Zolreta and Shoulder OA is progressing with top-line results expected in 2026.
Speaker Change: It is successful the study could make Zoretta, the first and only long-acting steroid, approved for use in shoulders.
Speaker Change: Shoulder OA represents a sizable market opportunity with approximately 1 million intra-articular injections administered each year.
Speaker Change: Thank you.
Speaker Change: David Amsellem, Balaji Prasad,
Speaker Change: That's for Iovera.
Speaker Change: On Friday, CMS issued their final Hospital Outpatient and ASC Prospective Payment System Rule for 2025.
Speaker Change: We're pleased to see that the rule includes a newly created product-specific code for Iovera.
Speaker Change: C 9809
Speaker Change: In its final rule, CMS concluded that Iovera meets the statutory requirements of no pain and qualifies for separate reimbursement in both the hospital and ASC settings.
Speaker Change: Importantly, the rule adopts a consistent add-on payment of up to $255 in addition to the standard Iovera procedural rates in the hospital outpatient and ASC sites of care.
Speaker Change: Our registrational study for Iovera for the treatment of spasticity is also underway with top-line results expected in 2026.
Speaker Change: given the significant lack of innovation and patient unmet need in this debilitating condition.
Speaker Change: We believe iAvera may offer a novel approach for patients with moderate to severe spasticity who are seeking treatment.
Speaker Change: The IAVERA team is also preparing to file for approval of a new IAVERA SmartTip later this year.
Speaker Change: This tip is specifically designed for use in chronic low back pain, which impacts millions of Americans and often leads to poor quality of life, disability, and prescription opioid use.
Speaker Change: Switching gears for Early Stage Pipeline.
Speaker Change: We continue to be encouraged by the potential of PCRx201, our novel gene therapy, for the treatment of osteoarthritis of the knee.
Speaker Change: It's innovative high-capacity adenovirus or HCaD design, manufacturing process, and local administration.
Speaker Change: solve for many of the challenges that have made gene therapy inaccessible for common diseases.
Speaker Change: Please see the complete disclaimer at https://sites.google.com or at https://sites.google.com.
Speaker Change: Key attributes of 201 include the following.
Speaker Change: The HCaD viral vector is more efficient at delivering genes into cells than other vectors.
Speaker Change: This means less medication is needed to achieve the desired effect.
Speaker Change: PCRx201 is delivering medicine where it matters.
Speaker Change: It's injected locally into the knee joint capsule and contained there, leading to a robust clinical effect and favorable safety profile.
Speaker Change: Smaller doses, local administration, and scalable manufacturing result in an attractive cost-of-goods profile.
Speaker Change: PCRx201 has already exceeded expectations in an early stage clinical trial. In this large phase one study of 72 patients with moderate to severe knee OA, a single intra-articular injection of PCRx201.
Speaker Change: demonstrated pain relief and durability across all levels of disease severity as measured by the WOMAC scores.
Speaker Change: The study enrolled two 3-dose cohorts, a co-administered steroid cohort, and a cohort that did not receive a steroid.
Speaker Change: Earlier this year we presented one-year data. PCRx201 was well tolerated with efficacy observed across all doses studied.
Speaker Change: The greatest efficacy was observed in the steroid pre-treated group, with 75% of patients achieving at least 50% improvement in pain and stiffness versus baseline for all three doses.
Speaker Change: A 20% improvement is considered clinically meaningful.
Speaker Change: So these results are highly encouraging.
Speaker Change: We continue to follow these patients and look forward to reporting exciting new two-year data at the American College of Rheumatology's annual meeting next week.
Speaker Change: Thank you.
Speaker Change: While other therapies typically provide relief for three to six months, PCR-201 has already set a new standard with a year or more of sustained pain relief from a single injection.
Speaker Change: PSARS-201 is the first gene therapy to achieve these results and the only OA gene therapy to earn the FDA's RMAT designation, a testament to its promise and potential to revolutionize the treatment of NeoA.
Speaker Change: As a primer to PCARC's 201 presentation at ACR, we made an educational webinar available in the investor section of our website.
Speaker Change: We invite you to watch and learn more about this exciting asset.
Speaker Change: The last item I'll quickly touch on before closing is the District Court's recent ruling on our 495 patent litigation.
Speaker Change: While this was of course not the outcome we had hoped for, it is important to remember that this was only the first case.
Speaker Change: Our legal strategy is comprehensive and includes pursuing an appellate review with respect to an injunction based on information received through ongoing court proceedings.
Speaker Change: We do not believe irreparable harm from an at-risk launch is eminent at this time.
Speaker Change: If this changes, we're prepared to adjust to our legal strategy accordingly.
Speaker Change: As a reminder, in order to be commercially successful, we believe EV-ness will need to have overcome all of our patterns.
Speaker Change: Importantly, the team continues to innovate.
Speaker Change: and additional patents are forthcoming.
Speaker Change: We're also awaiting a trial date for the second lawsuit that's progressing in the New Jersey District Court. This case involves our 574 patent, which we believe represents a higher hurdle for defendants to clear.
Speaker Change: The 574 patent claims composition of experil, but it includes the volume limitation that Judge found lacking in the 495 case.
Speaker Change: We will continue to take the necessary steps to protect the interests of our business, shareholders, patients, and other stakeholders.
Speaker Change: We firmly believe we've built a strong portfolio of intellectual property and that the ex-parel franchise is well protected on multiple levels.
Speaker Change: Before I turn the call over, I'd like to formally welcome our new Chief Financial Officer, Sean Cross.
Speaker Change: Sean's a seasoned industry veteran with more than 25 years of global experience as a biotechnology executive, board member, and investment banker.
Speaker Change: And I'm confident you'll be a great steward of our financials and provide valuable insights and strategies as we advance our plan for long-term growth and value creation.
Speaker Change: I'd like to thank Lauren Riker, our Senior Vice President of Finance, who served as our interim CFO. Lauren has been with Pacera for 13 years, during which time she's demonstrated exceptional leadership and financial acumen.
Speaker Change: I'm grateful to Lauren for ongoing dedication and willingness to accept this responsibility during this transitional period.
Speaker Change: With that, I'll turn the call over to Sean for review of our financials.
Speaker Change: Thank You Frank for that warm welcome and good afternoon to all on the call. I'm excited to join Visera at this important juncture as I'm strongly aligned with the company's important mission to deliver innovative non-opioid pain therapies.
Speaker Change: This year is on strong financial footing with a business that is generating significant cash flow driven by three best-in-class market-leading products.
Speaker Change: I'm excited to work alongside the talented and dedicated Pacero leadership team as we invest in our next phase of growth and beyond.
Speaker Change: Turning now to the financials.
Speaker Change: I'll start with an update on sales and margin trends. Third quarter expro sales increased to $132 million versus $128.7 million in 2023.
Speaker Change: Thank you.
Speaker Change: Third quarter Zonretta sales of $28.4 million were essentially flat versus the $28.8 million reported in 2023.
Speaker Change: For Iovera, sales were $5.7 million compared to $5.3 million in the third quarter of 2023.
Speaker Change: Turning to gross margins.
Speaker Change: On a consolidated basis, our third quarter non-GAAP gross margin was 78%.
Speaker Change: This was driven by strong margins for all three products.
Speaker Change: For non-GAAP R&D expense, the third quarter decreased to $17.3 million from $18.6 million reported last year.
Speaker Change: This decrease relates to declines in product development and manufacturing capacity expansion costs.
Speaker Change: as well as regulatory expenses.
Speaker Change: These declines were partially offset by clinical study startup costs.
Speaker Change: As a reminder, our pre-commercial scale of activities are now complete and the 200 liter X-Beryl manufacturing suite in San Diego began producing commercial inventory in July.
Speaker Change: David Amsellem, Balaji Prasad,
Speaker Change: Non-GAAP SG&A expense came in at $65.0 million for the third quarter.
Speaker Change: which is up from 58.9 million last year.
Speaker Change: This increases largely due to litigation costs as well as the investments we are making in our commercial, medical, and market access organizations.
Speaker Change: Thank you. Thank you. Thank you.
Speaker Change: All of this resulted in another quarter of significant adjusted EBITDA of $54.7 million.
Speaker Change: One last item to note on our DAP P&L is $163.2 million non-cash, non-recurring charge related to goodwill impairment.
Speaker Change: This was assessed following the New Jersey District Court's decision on our first ex parel patent lawsuit.
Speaker Change: As for the balance sheet, we exited the third quarter in a position of strength with more than $450 million of cash and investments.
Speaker Change: With a business that has produced significant cash flow, we are well equipped to advance our long-term growth strategy and drive long-term shareholder value.
Speaker Change: Turning to guidance.
Speaker Change: Today we are reiterating our full year guidance for 2024 as follows.
Speaker Change: Total revenue of $680 to $705 million.
Speaker Change: non-GAAP gross margins of 74 to 76 percent
Speaker Change: Non-GAAP R&D expense of $70 to $80 million.
Speaker Change: non-GAAP SG&A expense of $245 to $265 million.
Speaker Change: and stock-based compensation of $50 to $55 million.
Speaker Change: And with that, we'll turn the call back to Frank.
Frank Lee: Well thank you, Sean. In closing, I'm proud of the significant strides the Pacera team has made this year, including important progress on the market access front.
Frank Lee: This includes new J-code for Expiril and separate CMS coverage for both Expiril and Iovera under no pain.
Frank Lee: I'm energized by the potential for what's yet to come.
Frank Lee: All of the work completed to date positions us well to enter 2025 from a renewed place of focus on execution, commitment to our mission, and strategic clarity on musculoskeletal pain and adjacencies.
Frank Lee: We're confident the investments we're making will support and expand our leadership position in non-opioid pain management and ensure we are positioned for long-term growth and success. With that operator, we're ready to open the call for questions.
Speaker Change: Thank you. If you'd like to ask a question, please press star 1 1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1 1 again.
Speaker Change: Our first question comes from Oren Livnat with H.C. Wainwright. Your line is open.
Oren Livnat: Thank you.
Oren Livnat: Thanks for taking the questions. I have a couple.
Oren Livnat: I think you mentioned in the script that it would take customers a little bit of time to, I guess, implement no-pain changes. I'm just curious, can you just talk about how comfortable you are with...
Speaker Change: your ability to hit the ground running there with all the investments and improvements you've made in the last, you know, six months. And I guess, you know, I'm not expecting guidance, but can you just put a little more color around what kind of ramp and implementation on your customer end you expect, and maybe how long it would take customers to follow on on the commercial side. Thanks, and I have a follow-up.
Speaker Change: Thank you.
Speaker Change: Thanks for the question, Oren. As you mentioned, I'm super proud of the team and what we've accomplished. As you know, when we set out and
Speaker Change: provided our strategic direction and J.P. Morgan earlier this year.
Speaker Change: talked about investing to grow in the business and
Speaker Change: solidifying our mission, our long-term strategy, and importantly the commercial market access.
Speaker Change: and medical organization. And you can see that those efforts are actually paying off. If you take a look at the progress we've made now on.
Speaker Change: for the first time having a J-code for exproprial and now expanded.
Speaker Change: Reimbursement and Inclusion, and they'll pay for both ex-parole.
Speaker Change: And this is really a testament to the team's efforts this year. So I'm super proud and confident about the direction we're headed.
Speaker Change: As it relates to no pain, I do believe that it will take our customers some time, as I mentioned, so it won't be immediate. It will take some time for the customers to incorporate this into their sometimes large and complex organizations. And we're doing a lot now, but I would suspect that it's more second half of the year, next year, etc., and onward, where we'll start to see some real signs that it's taking hold.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Okay, um, and I guess just speaking of no pain in big picture
Speaker Change: You know, certainly a lot of us have on our mind results of the election last night and you guys The company and with your consultants obviously have a lot of experience working in Washington And I assume we're you know instrumental and maybe getting no pain done in the first place Can you help us understand your you know, what are your expectations longer term for implementation of that plan? Do you expect it to go beyond the three years? Obviously the constituencies and the Republican Party are very much affected by opioid Dependence issues also and but on the other hand, we've got you know, presumably some budgetary pressures on the other side So I'm just curious if you guys have a take on our confidence level on the long term
Speaker Change: coverage for non-opioid therapies.
Speaker Change: Yeah, it's a good question and you know what we're really encouraged by a couple things. First, in the seven plus years that's taken to get this no pain legislation across the line with a tremendous amount of support and advocacy from patient advocacy organizations like Voices.
Speaker Change: for Non-Opioid Choices.
Speaker Change: In that process, what we found is that there's strong bipartisan support.
Speaker Change: for really tackling this.
Speaker Change: that's out there still amongst patients.
Speaker Change: and so we don't expect that to change and we're going to work very closely with advocacy as we always do and I believe that over the coming years based on the data that we'll collect I'm very very confident that these investments that came through bipartisan support will pay off and will be recognized.
Speaker Change: All right, appreciate it.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Gregory Rinza with RBC Capital Markets. Your line is open.
Speaker Change: Hey guys, it's Anishan for Greg. Thanks for the updates this quarter and for taking our questions. Just a couple. Firstly, just to drill down a bit more on the ordering over the next year, year and a half.
Speaker Change: Just on the GPO contracting, how should we be thinking about the onboarding process, ordering and stocking within each organization? And then on no pain and reimbursement, how can this be leveraged to keep centers ordering and using XBARREL over the generic? Is ASP plus six enough? How are you messaging and educating on this? Thanks so much.
Speaker Change: and many more. Thank you. Thank you.
Speaker Change: So, thanks for the question, Aneesh. And these are early days, obviously, for the GPOs. And so we're going to work very closely with our customers to make sure that they understand the GPO contracts and we can help them pull it through at the local level in a way that helps patients and their organizations the most. So, stay tuned on that. We think that this is important, as we said before, to not only providing access, but fully leveraging no pain and providing access to these kinds of innovative treatments.
Speaker Change: When we think about the whole generic situation, I'm going to come back to, we shouldn't jump too far ahead. As we've mentioned, we believe that in order for a generic to be successful, there are multiple layers of patents.
Speaker Change: that need to be overcome. And as we mentioned, we not only have the 495, the 574, but we are continuing to innovate, as I mentioned earlier. So stay tuned on that.
Speaker Change: Thank you. Thank you. Thank you.
Speaker Change: Great, thanks so much.
Speaker Change: Thank you. Our next question comes from David Amselam with Piper Sandler. Your line is open.
Speaker Change: and many more. Thank you. Thank you.
David Amselam: I know there's not much you can really say beyond what you've already said about a generic entrant, but maybe I'll ask about it a little bit differently, which is that to the extent that
Speaker Change: an entrant materializes.
Speaker Change: I guess the question is, how do you think about the cost structure, how do you think about the potential for significant cost savings, how do you think about managing your margins in the context of a single generic entrant?
Speaker Change: So that's one set of questions. And then I guess the next question is as it relates to generic, I mean, is there – is
Speaker Change: Is it something that we should be worried about?
Speaker Change: on the competitive front regarding another filer or multiple filers emerging since there is one approved. It's one thing regarding a potential launch, but how are you thinking about the potential risk of other filers on liposomal B-pivocaine emerging? Thanks.
Speaker Change: and many more.
Speaker Change: David, just maybe a few things first.
Speaker Change: As we articulated previously, to the extent, if and when there is a single generic entrant, there are a number of analogs, and I believe Susan has
Speaker Change: a study here that she can forward to you that shows that typically there's some price erosion, 15-20%, in that case, as we've said before, we consider that competition.
Speaker Change: and we'll compete in that space. We don't believe, as I mentioned earlier, that an at-risk launch is imminent.
Speaker Change: So we continue to drive this business.
Speaker Change: and move it forward. We are certainly paying attention to the competitive environment, but we don't have visibility into any new ANDA filers. There's always some potential out there, but there have been no new filings that we've been noticed about.
Speaker Change: are called upon to...
Speaker Change: Thank you. Our next question comes from Gary Nachman with Raymond James. Your line is open.
Speaker Change: Hey guys, this is Tejasan for Gary. Congrats on the quarter. Can you guys talk just a bit more about the margin, where things went right there? You guys are kind of above your full year guidance. Was that coming from the new Exporel facility?
Speaker Change: And then, you know, now with the second GPO contract in place, things are starting to maybe firm up on the price going into no pain. How do you see that dynamic just playing out in the last quarter and then into 2025?
Speaker Change: Yeah, so that's a good question.
Speaker Change: We're certainly pleased about the margin improvement, but maybe I'll turn to Lauren here for some additional comment.
Lauren Riker: We were very pleased with our strong third quarter margins and it exceeded our guided range.
Speaker Change: from 74 to 76 percent.
Speaker Change: But on a year-to-date, you know, we believe we'll still land within that guided range if you look at it, we came in at 75% on a year-to-date basis.
Speaker Change: The first half was negatively impacted by Zylreta and Iovera, so Xpiril has continued to be strong and we think that trend will continue.
Speaker Change: Thanks, Paul.
Speaker Change: I just had another follow-up kind of pivoting a little bit to 201 and what comes next for that program. Just kind of with the difficulties on XBRL, are you going to try to advance that program any quicker? Is there anything you want to do to kind of bring that program front and center, you know, just with everything that's been going on?
Speaker Change: David Amsellem, Balaji Prasad,
Speaker Change: David Amsellem, Balaji Prasad,
Speaker Change: Well, that's a good question. I have to tell you, I'm personally excited about the program. I've seen a number of phase one data sets in my time and this one I get excited about. And I get excited about some of the data that we'll share next week. And I guess I'll turn to our chief medical officer, Jonathan, to talk a little bit about what's ahead. Certainly, we're very much excited about this locally administered gene therapy for common diseases like OA. So, Jonathan, maybe you can talk about what's ahead for us.
Jonathan Slonin: Thanks Frank. As Frank articulated, we are really excited to be able to present our 104-week data at ACR and to talk about the potential to bring gene therapy to treat common diseases affecting millions of people.
Jonathan Slonin: We're also really excited about our clinical program as that advances and we kick off the next
Speaker Change: study at the beginning of next year. Along those lines our CMC process is progressing as well ahead of schedule. So we are full steam ahead and we're very excited about the potential of 201.
Speaker Change: Yeah, let me add on to that that sometime next year we'll provide better visibility into this next phase of the program, and we think it holds a lot of potential, not only for OA, osteoarthritis, but perhaps other common diseases as well.
Speaker Change: and John Molloy. Thank you. Thank you.
Speaker Change: Got it. Thanks for all the info, guys.
Speaker Change: David Amsellem, Balaji Prasad,
Speaker Change: Thank you. Our next question comes from Les Salewski with Truist Securities. Your line is open.
Les Salewski: Good evening. Thank you for taking my questions. Just a few for me. First, has the units provided you with a sample of their end-up product? I believe you mentioned that you're working through some logistics on the process of getting that worked out with the magistrate judge.
Les Salewski: just want to get the latest on that. Second, can you just remind us on the average out-of-pocket cost for eye of error treatment, you know, now that you've got reimbursement, how much does that 255 reimbursement cover of the total cost?
Les Salewski: And then second or third, I guess, on Zillowretta, we're still seeing kind of a script deterioration continuing from second quarter. What do you think is driving this and at what point to kind of see stability on the front? Thank you.
Speaker Change: Thanks for the question, Les. First on your question about the sample of product. No, we have not received a sample of the commercial product and of course we keep an eye on that. As I mentioned, we don't believe a launch is imminent.
Les Salewski: as I mentioned earlier.
Les Salewski: Second out-of-pocket is around $450,000 for Iovera and of course for the physician now and ASC and hospital outpatient departments.
Les Salewski: The value equation is quite improved, as I mentioned, another $255 on top of the current reimbursement. So we're super pleased about that. And just to give a shout-out to the team, Xparel and Iovera are among two of the 11 products.
Les Salewski: that were approved. So many were not. So it's really a testament to the product and the team's efforts.
Les Salewski: And finally, what I'll say about Zoretta is that historically, I think we've focused quite a bit on Expiril and Iovera, but what we recognize now is that there's quite a bit of potential for Zoretta.
Les Salewski: It's a very good product. Patients are very satisfied with this product.
Les Salewski: and we believe that Zoretta is promotionally responsive.
Les Salewski: Going forward, you'll start to see the...
Les Salewski: Some of the changes that we've made and how we're going to promote.
Les Salewski: Zoretta in the field and the kinds of things that we'll do on the marketing side, but
Les Salewski: We are bullish on zoonotic growth going forward.
Speaker Change: Very helpful, thank you.
Speaker Change: David Amsellem, Balaji Prasad,
Les Salewski: Thank you. There are no further questions. At this time, I'd like to turn the call back over to Susan Mesco, Head of Investment Relations, for closing remarks.
Les Salewski: Thank you, Michelle, and thanks to all on the call for your questions and time today. We are excited about the opportunities that lie ahead for us. Throughout the remainder of the year, we will continue to ensure we are well-positioned for long-term success. The opioid epidemic continues to be a national crisis, underscoring the vital importance of our mission. Thank you and be well.
Les Salewski: Thank you.
Speaker Change: Thank you for your participation. This does conclude the program and you may now disconnect. Good day.