Coherus Oncology, Inc. Q1 FY2024 Earnings Call

Thank you for joining us. I would like to welcome everyone to Coherus BioSciences, Inc. First Quarter 2024 Earnings Conference Call. I will now hand the call over to Jamie Taylor, Head of Investor Relations. Please proceed.

Thank you, operator. Good afternoon, and welcome to Coherus BioSciences First Quarter 2024 Earnings Conference Call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Bryan McMichael, our Interim Chief Financial Officer; Paul Reider, our Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa LaVallee, our Chief Development Officer. Before we get started, I'd like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, the following, our ability to advance our pipeline, projections of future growth, revenue, expenses, headcount, and debt levels. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process that are discussed in our press release that we issued today, as well as in the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date and we undertake no duty to update or revise any forward-looking statement. And now, I'll turn the call over to Denny.

Thank you, Jami. Good afternoon, everyone, and thank you for joining us on our call today. As we open the call, let me emphasize two things. First, the strength of our first quarter results and secondly, the strategic initiatives we are successfully executing to position our company for long-term success. As you are aware, in the fourth quarter of 2023, we received two US FDA approvals for products vital for our commercial portfolio. First, LOQTORZI for nasopharyngeal carcinoma, a rare and devastating cancer for which it is the only FDA-approved therapy. And the UDENYCA on-body injector, an innovative drug delivery mechanism with novel features that opens up large portions of the pegfilgrastim market that we previously could not access. In the last three months, we launched both products, leveraging synergies derived from our company's focus on oncology. Our Chief Commercial Officer, Paul Reider, will describe these launches in more detail shortly and share with you the enthusiasm with which both products have been received in the market and the revenue growth each has experienced this quarter. Recently launched innovative products are fully aligned to our company's mission of extending the survival of cancer patients. On the development side, in just a moment, Dr. Theresa LaVallee and Dr. Rosh Dias will describe how our R&D pipeline is advancing to plan, with impressive data consistently presented at major medical conferences and more to come. Across every key dimension, the company is executing well and on plan. Regarding strategic initiatives, we are focused on exercising our strategic optionality to strengthen the company's balance sheet and enhance long-term value for our shareholders, consistent with our mission. This is particularly relevant to the commitment we have demonstrated, strengthening Coherus' capital structure, where strong progress has been made. I'll highlight just two recent steps and developments. Early in the first quarter, we announced the divestiture of CIMERLI, a non-core, non-oncology asset for a $170 million upfront cash payment, plus an additional $17.8 million in cash for inventory. This divestiture has allowed us to pay down a large portion of our $250 million term loan debt while reducing interest costs, reducing headcount and overhead costs, and significantly improving our gross margins. Today, we announced a new non-dilutive debt and royalty financing, which fully repays the remaining $75 million, which was otherwise due in October of 2025. With this transaction completed, we have now reduced our structured term loan debt by 85% over the recent three-month period, moving the due date out five years to 2029 with no springing maturity. The timeline for debt maturity under this agreement extends beyond the development horizon of our products. And with that, let me turn the call over to Paul Reider. Paul?

Thank you, Denny, and good afternoon, everyone. With the ophthalmology divestiture, we are now an oncology-centered commercial organization which supports our overarching business objectives. The ongoing oncology launches like LOQTORZI, UDENYCA ONBODY, and UDENYCA autoinjector enable singular focus on driving top-line revenue. We are executing to plan and are pleased with our progress. Regarding the quarter's performance, total net product revenue was $76.7 million, a 137% increase over Q1 2023. For our core oncology brands, Q1 UDENYCA net revenue was $42.7 million, an 18% increase quarter-over-quarter and a 63% increase over Q1 2023. LOQTORZI net revenue was $2 million in the quarter, still early in the launch and in line with our expectations and with new patient accrual momentum building. Regarding our non-core products, Q1 net revenue for YUSIMRY was $3.9 million, showing 77% growth quarter-over-quarter. CIMERLI, given the deal closed on March 1st, net revenue for the quarter was $28.2 million and only reflects sales for January and February. I'll now speak in more detail about our core oncology assets, starting with LOQTORZI. The commercial launch of LOQTORZI now establishes Coherus in the immuno-oncology therapeutic area, serving as the foundation upon which we will commercialize our exciting pipeline of I/O products. LOQTORZI has a broad label and is approved in combination with CisGem for first-line treatment of adults with metastatic or with recurrent locally advanced NPC, and as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Today, the standard of care is chemotherapy, so our ambition is to establish LOQTORZI plus chemo as the new standard of care and offer NPC patients the hope for greater survival based on the final overall survival results from the JUPITER-02 trial in which LOQTORZI plus chemo resulted in a 37% reduction in the risk of death versus chemotherapy alone. Educating NPC treating oncologists on these clinical data remains a top priority and is being amplified by the advocacy of the nation's leading NPC opinion leaders who have affirmed the strength of the LOQTORZI clinical data and its position as the new standard of care. Since launch, we've achieved a series of milestones necessary to enable broad prescribing over the course of 2024 and beyond. I'll highlight four examples. First, LOQTORZI was included in NCCN, ASCO, and Clinpath guidelines. In NCCN, LOQTORZI is the only PD-1 with Category 1 designation for first-line use and the only preferred regimen in second line plus. Second, payer coverage has been confirmed now on greater than 85% of medical benefit lives and health plans, including Medicare fee-for-service, Medicare Advantage, and national and regional commercial plans. Third, among the top academic research hospitals, LOQTORZI was added to the formulary on 55% of the 33 NCCN institutions with the remaining institutional reviews scheduled. It is highly expected that formulary position will be achieved with all NCCN institutions by the end of Q2 2024. Finally, a product-specific permanent J Code has been granted by CMS which will take effect July 1, 2024. This will enable more efficient billing processes and speed the time to reimbursement for providers. Based on LOQTORZI's labeled indication, we estimate approximately 2,000 patients will fall within the addressable market opportunity for LOQTORZI. With a hospital formulary conversion process underway and the enthusiasm with which the community is embracing the product, we are building momentum as the launch continues. In Q1, approximately 80 patients received LOQTORZI treatment across all lines of therapy: combination with chemo or as monotherapy, which was in line with our expectations. We're pleased that the launch is progressing to plan. Now, turning to UDENYCA. UDENYCA delivered another quarter of revenue growth driven by continued strong execution. The strength of our execution is fueled by three drivers. First, the commercial launch of UDENYCA ONBODY, a novel proprietary state-of-the-art delivery system for pegfilgrastim, enabling UDENYCA to now compete across the entire pegfilgrastim market. Second, UDENYCA is the only pegfilgrastim brand with three device options to meet the unique needs of providers and patients. This strengthens our competitive position and allows us to compete on factors other than price. Third, we come into 2024 with payer coverage nearly twice that of 2023, opening up access to significantly more patient lives. As for key performance indicators for the quarter, UDENYCA franchise demand grew 36% quarter-over-quarter, driven primarily by the pre-filled syringe and auto-injector presentations. In addition, franchise market share was 25%, an increase of 10 market share points quarter-over-quarter. Regarding the launch of UDENYCA ONBODY, customer receptivity has been very positive. Specifically, providers are pointing to UDENYCA ONBODY's 5-minute injection time, which is approximately 90% faster medication delivery than Neulasta Onpro. This is noted as a key differentiator, and this differentiation is translating into strong customer adoption. In summary, the UDENYCA franchise now offers providers and patients the total solution, and we expect continued unit and revenue growth with a focus on improving margins over the course of 2024. I'll now turn the call to Dr. Rosh Dias, our Chief Medical Officer. Rosh?

Thanks very much, Paul, and good afternoon, everyone. LOQTORZI, or toripalimab, with a profound survival advantage demonstrated in nasopharyngeal carcinoma, together with additional positive efficacy data sets published across a variety of tumor types, continues to form the foundational element of our immuno-oncology portfolio. As an IO company with an approved and highly efficacious PD-1, that affords us the opportunity to pursue three distinct strategies for further development of a wider variety of tumor types. Firstly, combinations with our own internal pipeline, which consists of three competitively well-positioned assets, tightly focused development plans, all of which are progressing according to plan: casdozokitug, our IL-27 targeting antibody; CHS-114, our CCR8 targeting antibody; and our anti-ILT4. Secondly, development opportunities where toripalimab is studied in combination with novel compounds with INOVIO term registration opportunities fully funded by partner companies in Phase III registration-enabling studies, such as the INOVIO vaccine combination study in head and neck squamous cell carcinoma sponsored by INOVIO where we're providing toripalimab supply, and the ongoing Junshi BTLA-toripalimab combination study in limited-stage small cell lung cancer. And thirdly, development opportunities for toripalimab with partner companies that have earlier-phase novel compounds for which they are looking for a PD-1 partner. With respect to our internal pipeline, let me first start with casdozo. We remain excited about the potential of casdozo in both non-small cell lung cancer, where we have demonstrated monotherapy activity in PD-L1 refractory subjects in the advanced setting, and also in hepatocellular carcinoma, where we have demonstrated encouraging overall response rates in the first-line advanced setting. We're taking forward the non-small cell lung cancer data with our Phase II study that is currently ongoing and is active in the U.S. and where we remain on track to report data towards the end of this year or early next year. Our second development program with casdozo in advanced HCC also remains on track to start in the second half of this year, building upon the promising data presented earlier this year at ASCO GI. Turning to CHS-114, our CCR8 afucosylated antibody, we've continued to make good progress through dose escalation and are now moving on to the next stage of the study with expansion into head and neck squamous cell carcinoma, where the disease linkage is particularly strong. We're excited that an abstract has been accepted for presentation at ASCO in a few weeks' time for further detailed data from the dose escalation portion of the trial. Theresa will speak more about the status of our ILT4 program and will highlight data presented at the recent AACR meeting. Next, with respect to our pivotal partnered programs with nearer-term registration opportunities, our partnership with Innovia continues with the Phase III registration-enabling study in HPV-positive locally advanced head and neck squamous cell carcinoma currently actively in development. In addition, the toripalimab BTLA Phase III combination study in limited stage small cell lung cancer, led by our partner Junshi, continues to progress in the U.S. and also other multiregional sites. This serves as a further example of the potential of toripalimab to act as a foundational element for novel combinations. Finally, with respect to earlier-stage novel combinations, we were delighted to announce yesterday that toripalimab was selected by the Cancer Research Institute as the PD-1 backbone for exploration with EMV therapeutics endothelin B inhibitor within a platform ovarian cancer study exploring novel combinations in this patient population that has historically been underserved by immunotherapy. Selection of toripalimab by CRI provides further validation of our strategic trials approach of utilizing toripalimab as an investigational PD-1 backbone in these areas outside of NTT. I'll now turn the call over to Dr. LaVallee, our Chief Development Officer. Theresa?

Thank you, Rosh, and good afternoon, everyone. I'm pleased to update you on additional progress in our efforts to pursue the development of our tumor microenvironment focused pipeline. We have two approaches: combinations broadly with immune activators with partners, and internal development plans focused on combinations with LOQTORZI. The casdozokitug clinical data in non-small cell lung cancer and HCC presented in December 2023 and January 2024 have demonstrated clinical efficacy in early clinical studies. Importantly, the studies show a favorable safety profile, lending casdozo as a combination treatment and, of equal importance, immune activation in cancer patients. In the casdozo Phase I study, the biomarker data show that casdozo doses of 10 mgs per kg or higher, but not at 3 mg per kg or lower, inhibit IL-27 signaling and further, NK and T cells are activated. While rebalancing the immune system with anticytokine antibodies is well established in inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis, this approach has not yet been successfully demonstrated for the treatment of cancer. Casdozokitug is an antagonist and first-in-class. It blocks IL-27, which is in the IL-23, IL-12, IL-6 family of cytokines, a family that has multiple approved antibody drugs in inflammatory diseases. Our Scientific Advisor, Dr. Christopher Hunter from the University of Pennsylvania, was honored for his research on IL-27 with the distinguished lecture at the American Association of Immunologists Congress in Chicago on May 4. In Dr. Hunter's lecture, he described the basic research of mouse models to understand the immune regulatory role of IL-27 and how the absence of IL-27 results in immune pathology due to an overactive immune system, specifically dysregulated and activated T cells and NK cells. Interestingly, these effects are most notable in liver, lung, and brain tissue. In translation of this work to cancer and treatment of patients with casdozokitug showing antitumor activity in lung and liver cancer is very exciting. The strong line of sight for tumor indications where IL-27 biology is critical for regulating immune response allows Coherus to have a focused development plan. I'm also proud to say that at the recent AACR meeting, our team presented IND-enabling studies for the ILT4 antibody CHS-1000. CHS 1000 is our first internally discovered and developed IO drug candidate. We remain on track for FDA feedback on the IND in the second quarter of 2024. I'll now turn the call to Bryan McMichael.

Thank you, Theresa, and good afternoon, everyone. Since Denny covered the updates to our capital structure and Paul covered revenues, I will focus on the rest of the P&L and cash. Cost of goods sold during Q1 2024 was $34.6 million. Excluding the impact of the inventory write-down in Q4, COGS would have decreased $3 million or 8% from Q4 2023. R&D decreased $5.7 million and 17% from Q1 a year ago, primarily reflecting savings from reduced headcount and reduced development costs on biosimilars, partially offset by investments in our IO pipeline. SG&A increased to $7.4 million and 15%, driven by a net $6.8 million charge in Q1 2024 associated with the non-cash write-off of NZV930, which is now licensed obtained in the Surface Oncology acquisition that was terminated by Novartis. For the first quarter of 2024, we reported net income of $102.9 million or $0.83 per diluted share compared to a net loss of $75.7 million or $0.96 per diluted share for the same period in 2023. Non-GAAP net loss per share, which excludes the gain on divestiture and the net charge associated with the termination from Novartis mentioned earlier, was $35.8 million, or $0.32 per diluted share in Q1 2024 compared to $59.5 million or $0.75 per diluted share for the same period in 2023. Cash and cash equivalents and investments in marketable securities were $259.8 million as of March 31, 2023, compared to $117.7 million at year-end. As noted earlier, we used the cash on hand to pay $175 million in principals after the quarter ended. Today, we are reiterating our expected range of combined 2024 R&D and SG&A expenses of $250 million to $265 million. This guidance includes approximately $40 million of stock-based compensation and excludes business development activities and other unforeseen activities. With that, I will turn the call back over to Denny for closing remarks.

Thank you, Bryan. As we have emphasized throughout our remarks today, we are executing well on our four-part plan to deliver shareholder value. First, driving the top line of our revenues, and secondarily, controlling our operating expenses. We are making great progress advancing our pipeline of tumor microenvironment focused assets and lastly, as I disclosed, improving our capital structure. I'm fully confident in both the progress we are making and the path we have charted as an innovative oncology company. Operator, we're now happy to open the line for questions.

Your first question comes from Yigal Nochomovitz with Citi.

This is Ashley Mubarak coming on for Yigal. I joined a little bit late, so I apologize if I missed this, but how are you thinking about the contribution of each presentation of UDENYCA to the revenue mix for the quarter? And more importantly, how's that going to look moving forward? I kind of assume that weighting will increase towards the new presentations, but I'm wondering how you're thinking about it.

Thank you very much for your question. Paul Reider will be happy to further describe the contribution revenues for the three presentations that we now have on the market. Paul?

Yes. In the first quarter, the pre-filled syringe still represented the largest share of our SKU mix, around 90%. The autoinjector is around 8%, and the ONBODY came in around 2%, recalling that we launched mid-quarter, so we only had about half of the quarter of the ONBODY. So that's the breakdown of the SKU mix. It varies a little bit by segment. Clinics and hospitals tend to customize the SKU that works best for them, which is exactly how we are now competitively positioning the franchise. We're the only franchise that can offer providers and patients three different options to meet the unique needs of each individual patient or how they deliver pegfilgrastim. So you could see how that differentiation has translated into market share growth, with a 10 percentage point increase quarter-over-quarter to 25%. We will continue to drive that differentiation as the remainder of the year unfolds.

Paul, how do we see the market share of each of the presentations evolving through the rest of the year? Do you have any line of sight on that?

Yes. I think it's still early in the ONBODY launch, so we are gaining feedback from customers as to where it's fitting in. I can tell you right now that it's moving primarily in the clinic segment and also different segments of the hospitals. However, I think we're still going to see, throughout this year at least, the pre-filled syringe hold a good percentage of the SKU mix, with the remainder being the auto-injector and the ONBODY. The ONBODY growth has largely been in the clinic segment, and we would expect that to continue throughout the year.

Thank you for your question.

Next question comes from the line of Kripa Devarakonda with Truist Securities.

For LOQTORZI, you mentioned that the launch is going well. Can you provide some color on whether the drug has been used more in front line or second line setting? You also mentioned that it can take time to get on the formularies. You talked about 55% being on 55% of the 33 NCCN hospitals. Is this in line with your expectations?

Kripa, thank you for your question. Paul would be happy to comment a little bit about frontline versus second line utilization and the 55% NCCN conversion. Paul?

Thanks for your question. Going back to the labeled indication for LOQTORZI, it's indicated in the earlier stage of the recurrent locally advanced patients, and we are seeing LOQTORZI used in those patients. In that case, it's typically combined with chemotherapy. We also saw, as expected, contributions of LOQTORZI in both the metastatic setting in both the frontline and second line plus. As for the formularies, yes, that's very much in line with our expectations. Academic medical centers have processes. It takes time to go through those formularies. We would expect all the remaining NCCN institutions to be completed by the end of the year.

Next question comes from the line of Mike Nedelcovych with TD Cowen.

I have two questions. The first is also on LOQTORZI. Your progress in gaining formulary access is impressive. Is that basically the lever that's needed to be pulled in order to displace any residual off-label prescription of other checkpoint inhibitors, or is there additional work that needs to be done from a marketing or physician education perspective? My second question is on YUSIMRY. I think in the past you've suggested that 2025 could be an inflection year for a biosimilar like YUSIMRY based on some of the IRA provisions. Are you still thinking about it that way? Does YUSIMRY have a bright future ahead? What is your latest thinking on YUSIMRY's outlook?

Great. Thank you for the question. I'll let Dr. Rosh Dias first address the issue of the therapy selection decision that physicians now have with the launch of LOQTORZI, and then Paul can secondarily talk about YUSIMRY. Rosh?

Yes. Thanks very much for the question. Doctors tend to be pretty evidence-driven, and we have three things that no other PD-1 has. First, we have an indication. Secondly, we have a profound survival advantage in the first-line setting, a 37% risk reduction of death. And, again, that's in the context of negative trials with other PD-1s in nasopharyngeal carcinoma. The third point we have is a preeminent positioning on the NCCN. In the first line, we are the only Category 1 designated IO therapy, and in second line and beyond, we have the only preferred regimen. I think as we start seeing patients, these three things are key, and Paul's team is continually messaging on those three things.

Thank you. Paul, do you want to comment a little bit on our expectations for YUSIMRY going into 2025 with IRA?

Sure, Denny. Thanks for your question, Mike. Yes, for 2025 formulary negotiations are ongoing. YUSIMRY and Coherus are actively engaged in that process. So we continue to believe that that will be the inflection point where we see even greater inflection of biosimilars in the adalimumab space. I think we're well-positioned there based on our price point and the value that this product brings to the healthcare systems and patients.

Your last question comes from Balaji Prasad with Barclays.

This is Shau on for Balaji. Just a quick follow-on question on the UDENYCA franchise. Amneal recently announced that they are licensing the pegfilgrastim ONBODY injector and pre-filled autoinjector, and they expect to submit the BRA in the first quarter of 2025. There are a few other players that are trying to get into this landscape. What is your expectation for the pegfilgrastim ONBODY injector landscape and the entire market for the next two to three years? Do you have any plans or mechanisms to build and defend your market shares against those potential new entrants?

I'm sorry, but we're having difficulty hearing you. Can you clarify your question? Are you asking about future competitors in the ONBODY space related to the pegfilgrastim market or about autoinjectors?

Pegfilgrastim market, especially the ONBODY injector and the auto-filled pre-filled autoinjector, as Amneal recently announced that they have something in plan and they plan to file a BRA in the first quarter of 2025.

Paul, would you like to address how we view the competition in the pegfilgrastim market for future autoinjectors?

Yes. First of all, we have been operating in the pegfilgrastim market for six years and hold a leadership position. We will continue to focus on our business and the positioning of UDENYCA as the total solution for providers and patients. We have all three presentations available, which are well established in the market. Additionally, we have strong payer coverage, and payers recognize UDENYCA as a go-to brand because of the benefits we provide in terms of consistency, predictability, high quality, and reliability. We are prepared for any competition that may arise, but we believe we will remain well-positioned to compete and win, regardless of how the market evolves.

Thank you, Paul. The other point that I would make is consistent with Paul's remarks, our ONBODY injector represents an innovative de novo, highly sophisticated device with a 5-minute injection time. The enthusiasm with which it has been received by the market, the physicians, and the patients is due to that. We believe there are significant technical hurdles to such an approach, and we investigated a number of approaches before settling on this one. We think this is very important. We are confident in our ability to compete and remain successful and grow share in this market.

Another question comes from the line of Douglas Tsao with H.C. Wainwright.

There are a number of gates that you need to clear in terms of the ramp-up for LOQTORZI in particular, getting onto formulary. How quickly do you think you can get through those and sort of have access at most of the majority of the market? What other steps do you think we might need to clear before we really start to see an acceleration in the revenue trajectory?

Thanks for your question, Doug. Paul, would you like to comment a little bit on the gating of the adoption of LOQTORZI and how we do that?

Yes, thanks for your question, Doug. Yes. Obviously, payer coverage is the first one, and that's well established. I don't foresee any further hurdles on the payer side. The second gate is now that we've got the NCCN guidelines, it's critical we ensure that those guidelines translate into the order sets for each of the accounts. This enables the doctor at the time of prescribing to have LOQTORZI, chemo combination available. That's ongoing but will typically settle over this next quarter. The next gate will be washing out all of the current patients that are on off-label PD-1s and establishing new patients with LOQTORZI as the new start. That's going to require continued promotion, both through our sales team and from KOLs, as well as our digital efforts. We will continue to invest in that so that at the time of decision, oncologists know that LOQTORZI and chemo is the regimen of choice for those patients. This is a rare disease, and ramping up will take time, which is why we expect growth to occur steadily over the years.

Doug, for all the reasons that Paul just elucidated, we see the growth of this market as a steady ramp up to peak market share and penetration, probably out around year 3. This isn't a market, such as a replacement enzyme market, where you can get out to these patients and find them immediately. These patients are in various stages of therapy. They may have been exposed to another PD-1. We're going to catch the patients that are on chemotherapy. Those are all eligible. They all will benefit. Some patients we will have to wait for them to progress to the second line. The key issue is, as Rosh Dias pointed out, we are the only first-line therapy from the FDA. We have a position on all of the formularies. We're doing very well with the NCCN. But the building blocks are in place for the market; we see a steady ramp forward in the future.

Okay, great. And maybe a follow-up question on the UDENYCA franchise. I'm just curious if you have any insight regarding how physicians are using the ONBODY device versus the autoinjector. Are there themes regarding the types of patients getting the ONBODY versus the autoinjector?

Paul, how are patients being directed to the autoinjector or ONBODY?

Yes, Doug. So let me frame this in a couple of different ways. First, let's take the clinics. The clinic segments are going to gear more towards all three presentations because they have patients who like to come back to the office the next day. They prefer high-touch connectivity with their nurse and their doctor, so the pre-filled syringe or the autoinjector are positioned for those patients. Some patients in the clinic prefer their injection experience at home, therefore we give them the option of the ONBODY device with a well-designed 5-minute injection. If the patient wants to self-inject and not wear the device, they can choose the auto-injector and inject themselves at a time and place of their liking. That's how we are positioning by the patients and by the provider. Hospitals tend to go a little more with the ONBODY device or the pre-filled syringe. We've had good uptake with the autoinjector in the hospital, but not nearly as much in the clinic because they prefer either the pre-filled syringe or the ONBODY since it serves the at-home preference. This differentiation has set us apart from a competitive standpoint, saving up our market share growth.

Question comes from the line of Colleen Kusy with Baird.

For realizing you're not providing guidance at this point, but just how to think about what the growth drivers for UDENYCA will be in 2024? Is it growing the ONBODY? Is it focusing on the prefilled syringe and autoinjector? Just thoughts around growth for UDENYCA this year. Also, if you could just speak towards the potential of reaching cash flow positivity and if that goal is still set for 2024.

Thank you, Colleen. I'll let Paul handle the growth drivers for UDENYCA first, and then I'll handle your secondary question regarding 2024.

Yes, thanks for your question. We fully expect the ONBODY to be the predominant driver of our growth in 2024. The approval of that product opens up segments of the market that have been difficult to penetrate with our pre-filled syringe and autoinjectors. We're really looking for that SKU to drive market share growth for the remainder of the year, buoyed by payer coverage, which I mentioned was doubled this year versus last year. That coverage extends to all three product presentations, so we're not inhibited by the payer coverage for each of those.

With respect to your secondary question, I'd first say 2024 is shaping up to be a more predictable year than 2023. In 2023, we focused significantly on getting approvals. We successfully secured the ONBODY and LOQTORZI approvals. We are now rolling into the launches, particularly the launch of the ONBODY, the launch of the autoinjector, and now the launch of LOQTORZI. The trajectory over 2024 is continued revenue growth, and we believe we'll also see continued growth with respect to UDENYCA for the reasons Paul just outlined. The question remains how steep that growth curve will be based on prior experiences and the reality of being early in these launches. However, we are encouraged with our progress thus far.

There are no further questions at this time. Mr. Dennis Lanfear, I turn the call back over to you.

Thank you, operator. Thank you all for joining us on our call today. We look forward to updating you on our progress in driving our sales and advancing our tumor microenvironment-focused pipeline in our next call. Thank you.

You may now disconnect.