Coherus BioSciences, Inc.

Good day, and thank you for standing by. Welcome to the Q3 2024 Coherus Biosciences Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jody Sievers, Head of Investor Relations. Please go ahead.

Thank you, Daniel. Good afternoon, and welcome to Coherus Biosciences' third quarter 2024 earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coherus, Brian McMichael, Chief Financial Officer, Paul Reeder, Chief Commercial Officer. Dr. Rosh Dias, Chief Medical Officer. And Dr. Theresa LaValley, Chief Development Officer. Before we get started, I'd like to remind you that today's call includes forward-looking statements regarding Coheris' current expectations about future events. These statements include, but are not limited to, the following. Expectations for the time that it will take for our labeling and packaging CMO to resume packaging of Udenica. and projections about the timing and number of units that it will complete, projections about the timing and number of units that may be completed by our additional labeling and packaging CMO, and projections about future revenues, market share, and expenses. 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 our manufacturing process and our reliance on third parties that are discussed in our press release that we issued today, as well as 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 statements. And now, I'll turn the call over to Denny.

Thank you, Jodi. Good afternoon, everyone, and thank you for joining us today on the call. Today, we're pleased to share updates from the third quarter of 2024. Nine months into the year, we continue to first make good progress towards advancing innovative next-generation therapies with the potential to extend cancer patient survival. And secondly, execute well against our four-part strategy to deliver long-term shareholder value, specifically to drive top-line growth, control operating expenses, advance our pipeline, and improve our capital structure. While we have done well across each of these four dimensions, we are particularly pleased with the sales performance of the Udenica franchise through the third quarter, so I will focus there first. Significantly, Eudetica has achieved 100% revenue growth since Q3 2023, reaching $66 million in revenue this quarter. This includes a 30% increase from Q2 to Q3 this year as our franchise kicked into high gear, demonstrating that our three presentation franchise options, and it's the on-body, the auto-injector, and the pre-filled syringe, is working very well. and delivering exceptional value to customers. Also in Q3, Udenica retained its number two position in the market with nearly 30% share. We expect Udenica to return to market growth in 2025. Now let me address the Udenica supply interruption in our overall supply chain strategy for just a moment. I'm happy to report to you that based on the updated production schedule, our labeling and packaging contract manufacturing organization is resuming final packaging of Udentica this week. While this is a few weeks later than previously targeted, it's important to note that now that the CMO is restarting, they plan to process all 13 backlog lots without further interruption or delay. This comprises about 120,000 Udentica units, representing several months worth of supply. which are expected to be completed over the next five weeks. This will allow us to restock the distribution channels as fast as possible, as we expect to ship these final product lots as they are completed, making sure they get to our customers in an expedited fashion. Now that we have the schedule, we have started working with our channel partners and customers to understand and model how the restocking exercise will impact Q4 sales and the uptake dynamics. Since that effort is just now starting, we do not have a Q4 sales estimate for you today, but plan to provide one in early January. We've also made significant progress bringing an additional labeling and packaging CMO online in order to expand and further diversify our supply chain. Setup and test lots have been completed. Qualification of manufacturing is underway, and the requisite regulatory discussions are ongoing. Saleable lots are planned to start manufacturing in December, and once the product from this operation is authorized for sale, we will have successfully doubled our labeling and packaging capacity to over 1 million Udenica units annually, consistent with the rest of our supply chain. We will be ready to meet the growing demand for Udenica and expect substantial market share increases in 2025 and beyond. Now I'll turn to Lactorsi, approved in nasopharyngeal cancer, and our first commercial immuno-oncology agent. Lactorsi sales grew 54% quarter over quarter as we continue to execute well against our launch plan. Paul Reeder, my chief commercial officer, will provide more detail later on our call, so let me just say that we have tremendous confidence in long-term potential for Lactorsi in the treatment of NVC and as a foundational element of our combination therapy strategies. As our pipeline of innovative immuno-oncology drug candidates, let me share why I'm so excited about the opportunities there. First, our differentiated and diversified portfolio includes promising tumor microenvironment immunotherapy antibody drug candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunological response and improve outcomes for people living with cancer. Second, our targeted development strategy focuses on combinations that have established proof of mechanism, providing a strong line of sight into target tumor types with the most potential for improving efficacy in the areas of unmet need. And thirdly, our drug candidates target large addressable patient populations and attractive market opportunities across several high unmet need tumor types that in turn will drive substantial shareholder value in the upcoming years. As far as near-term catalysts, I will let Dr. Teresa Lavalle and Dr. Raj Dias speak to the detail, but we look forward to reporting on phase one and two clinical trials for CHS114 and CAS-DOHSO, respectively, in the first half of 2025. Lastly, I'd like to reiterate that disciplined financial management remains a high priority at Coherence, and we are now seeing the positive impact from our cost-saving efforts over the last year reflected in our balance sheet, which Brian McMichael, our chief financial officer, will cover later on this call. We are very confident in our ability to create long-term value for our shareholders through both our product portfolio and our competitively positioned pipeline. We are executing well against our strategy and goals for the year and are excited about where our vision can take us moving forward. And with that, I'll turn the call over to Paul.

Thank you, Denny, and good afternoon, everyone. Our dedicated commercial execution in oncology continues to deliver impressive results, highlighted by a sixth consecutive quarter of top-line revenue growth for Udenica and strong progress on Lactorsi following its third quarter of commercial launch. Total net product revenue for the quarter was $70.6 million, a 21% increase over Q2. Q3 Udanica net revenue was $66 million, a 30% increase quarter over quarter, and a 100% increase over Q3 2023. Lactorsi net revenue was $5.8 million in Q3, a 54% increase quarter over quarter. We reiterate our belief that Lactorsi will follow a steady revenue ramp in the near term, fueled by new patient acquisition, with sustained growth over time driven by duration, as 80% of long-term value is from early-line continuing patients, which we estimate will take three to four years to fully materialize. As I outlined in the Q2 call, there are approximately 2,000 NPC patients that are Lactorsi-eligible each year, and early-line patients represent approximately two-thirds of the total eligible population. Based on the impressive PFS and OS results from Jupiter 2, early-line NPC patients would receive the combination of Lactorsi and chemotherapy and are expected to have the longest duration of treatment and greatest therapeutic benefit. Therefore, acquiring early-line patients are a top priority. In Q3, the total number of Lactorsi-treated patients grew by more than 60% that approximately 70% of total Loctorsi patients are being treated in combination with chemotherapy, indicating we are making strong progress in acquiring our targeted patient population. It's still too early in the launch to make conclusions on duration of treatment, but based on real-world evidence, the majority of early-line patients who have started on Loctorsi remain on therapy. Overall, the launch is progressing well, and we continue to project that Lactorsi will achieve a dominant market share position in the NPC market that we estimate to be valued at $150 to $200 million. In the near term, our programs remain focused on three revenue drivers, driving new patient share through strong HCP and patient identification, ensuring Lactorsi messaging, is delivered at the time of treatment decision in optimizing the duration of Loctorsi treatment. Now, regarding Udenica, our overarching strategy for Udenica is to maximize the long-term revenue of the franchise. And I'm pleased to report Udenica delivered another quarter of revenue growth driven by continued strong execution and fueled by three drivers. First, the successful commercial launch of Udenica OnBody. Second, Udenica is the only Peg Philgraston brand with three different delivery options to meet the unique needs of providers and patients. And third, broad payer coverage, which opens access to significantly more patient lives. Today, Udenica is covered on over 60% of commercial Medicare Advantage and fee-for-service plans in 2024. And we anticipate 2025 coverage to be similar, if not better, than 2024. But despite overall franchise demand declining 3% quarter over quarter due to the temporary supply interruption, the 30% increase in Q3 revenue was driven by a 54% increase in demand for on-body, as well as a higher overall net selling price. Regarding Udenica OnBody, we remain pleased with the launch performance to date, and customer receptivity continues to be very positive. Demand for OnBody in Q3 is fueled by its differentiated features, such as OnBody's five-minute injection time compared to the 45-minute delivery for New Last to OnPro. In Q3, OnBody accounted for 21% of the franchise SKU mix, while the pre-filled syringe and auto-injector presentations represented 74% and 5% respectively. Regarding market share, Udenica maintained its number two position in the PEG filgrastim class with 28% market share. And with respect to the resupply plan that Danny laid out in his remarks, the replenishment timeline and quantity set us up to resume generating sales in the late November to early December timeframe. Therefore, we are focused on two priorities. First, replenishing the distribution channel, and second, working closely with each account to resume Udenica demand, the pace of which is difficult to predict, as it could take customers time to reestablish order sets and patient workflows. That said, we remain confident that customers will resume Udenica prescribing in Q4 with demand and market share acceleration in Q1 and throughout 2025, as the Udenica franchise remains in a strong competitive position based on our three brand pillars, the innovative and differentiated on-body presentation, the only brand with three device options, and broad payer coverage, which for 2025 looks to be as good were better compared to 2024. With that, I'll now turn the call to Dr. Theresa Lavalley. Theresa?

Thank you, Paul, and good afternoon, everyone. Now, to discuss our focus on the promise of the Coherence TME targeted pipeline for development in combination with toropalimab. PD-1 inhibitors have revolutionized cancer care, bringing long-term survival to some cancer patients. The limitation of PD-1 inhibitors is that the treatment only works in a minority of patients. In tumor types that are classified as hot, such as lung, renal, and bladder cancer, less than half of patients enjoy long-term survival benefit from PD-1 treatment. Moreover, there are many tumor types that do not respond to PD-1 inhibitors, and these tumor types are classified as cold or immune desert, such as pancreatic and colorectal cancer. For tumors that don't respond to PD-1 inhibitors, there have been a number of resistance mechanisms characterized, and two major ones are myeloid cell and Treg cell suppression of anti-tumor immune response blocking the activity of PD-1 inhibitors. Many of these mechanisms have been targeted and evaluated clinically, but have failed due to lack of single-agent activity, toxicity challenges, or not having targeted line of sight to indications for proof of concepts. In the next week at the annual CIPSE conference, we will present posters on Casdoza-Keta, or IL-27 antagonist that targets myeloid-driven suppression, and CHS114, our CCR8 cytolytic antibody that eliminates Treg cell suppression in the tumor. The CAS-DOSA-KETAG presentation will focus on the promising clinical data in non-small cell lung cancer, and particularly the squamous subtype, where CAS-DOSA-KETAG treatment has resulted in monotherapy responses, immune activation, and a safety profile that lends itself to combination with other agents. The translation of the preclinical data showing activity in lung and liver cancer to clinic is encouraging and forms a strong line of sight for proof of concept. We continue to advance CHS114, our cytolytic CCRH antibody that is designed to overcome the limitations of previous efforts targeting Treg cells, selectively targeting of tumor resident Treg cells avoiding broad Treg depletion leading to autoimmune toxicity, and also depletion of other T lymphocytes leading to decrease in anti-tumor immune activation. The CITC poster will expand on the CHS114 Phase 1 data presented at ASCO and support a selective depletion of CCR8 positive Treg cells with an excellent safety profile to date and show immune activation in cancer patients establishing proof of mechanism. The clinical study is now in dose optimization in combination with toropalimab and head and neck squamous cell carcinoma. The study is designed to address dose selection in alignment with FDA's Project Optimus and also safety biomarker and efficacy readouts. Many solid tumors have a high prevalence of CCR8 positive Treg cells. including immune non-responsive or cold tumors like colorectal and pancreatic cancer. The tumor types with the highest prevalence and density of CCR8-positive Tregs are head and neck, gastric, and cervical cancers. Advancing the clinical trials with CHS114 and torafalimab is a key aim for 2025, with anticipated data readouts in the second half of 2025. I'll now turn the call to Dr. Diaz, our Chief Medical Officer. Raj?

Thank you, Teresa, and good afternoon, everyone. Blocked TORSI as the foundational asset of our immuno-oncology portfolio remains the only indicated agent in nasopharyngeal carcinoma with its demonstrated profound survival advantage in first-line and strong data in second-line and beyond. Perhaps most importantly for further development, with its FDA approval in NPC, it does give us the ability to continue to develop it together with our pipeline across additional tumor types as our foundational PD-1 combination agent. We previously articulated our development strategy outside NPC to be formed by three key strategic pillars, which represents an effective and efficient way of resource allocation to optimally develop our IO pipeline. Firstly, combination with our internal pipeline of the very well-contestively positioned assets, Casdosa-Ketog, our first-in-class IL-27 targeting antibody, and CHS114, our CCR8 phytolytic antibody, which affords us the opportunity to further explore the patient benefit of Loctalzy in combination with our own pipeline in tumor types beyond the NPC indications in areas that are underserved by immunotherapy. Secondly, Combination with external partner compounds at the discovery or close to discovery stage, which allows us to develop Loctosi in combination with early stage development assets in additional tumor types, such as a study in combination with EMV therapeutics and the Cancer Research Institute, where we're providing Loctosi in ovarian cancer. And thirdly, combination with external partner compounds at the later registration enabling study stage, where again, We're providing Loctorsi for combination with later stage external agents, such as the combination study with the Inovio vaccine in head and neck cancer, and also the combination with Junishi's BTLA in limited stage small cell lung cancer, which again allows us to develop Loctorsi in additional tumor types with combination partners. For the latter two approaches, whilst we're providing Loctorsi, our development partners bear the development costs of these trials. Let me now take each of these in turn, starting first with our internal pipeline development. Firstly, CasDozo KeyTug. We're developing CasDozo in two specific indications, non-small cell lung cancer and hepatocellular carcinoma. Both approaches build on very encouraging datasets previously communicated at international congresses, with further data from these trials to be presented at upcoming congresses. For non-small cell, CasDozo has shown monotherapy activity in advanced disease, with both partial responses being observed in squamous cell carcinoma patients, where IL-27 is more densely present, and where, arguably, there's a greater unmet medical need. Both responses were also in PD-L1 refractory subjects and in less inflamed tumors. We're taking these data forwards in our ongoing trial in the U.S. with the Casdose-Toripalamab combination in advanced disease, which includes key academic centers in the U.S. and is recruiting two plans. For HCC, CASDOVA has shown encouraging responses in the first-line setting when added to the existing standards of care, ATISO and BEV, with data presented at ASCO GI at the start of this year showing an overall response rate of 38% with three complete responses, and an increase from the 27% ORR and zero complete responses communicated a little over a year ago. Again, we look forward to communicating We're building upon these data with a new study in the U.S. previously communicated of Casdozo in combination with Tori and Bev, and we remain on track to open this multinational study later this year. With a relatively low anti-drug antibody rate of Tori, we remain excited about the potential of this particular combination as the current standard of care Atizo with Bev has a high ADA rate that may hinder patient benefit. For CHS114, our primary approach is in head and neck squamous cell carcinoma, a tumor type that is complementary to our existing Noctursi indication. Where disease linkage is strong and our ongoing trial in the U.S. investigating both monotherapy and combination with Tori continues to recruit to plan. As a reminder, we're aiming to get paired biopsy samples from this study and are planning on increasing our patient number, further indication expansion in head and neck. I'm also pleased to announce that we're currently in planning to open a further study with CHS114 in combination with tori in gastric cancer on the basis of strong disease linkage showing a high prevalence of CCR8 positive Tregs in gastric cancer and the encouraging data from Lenova presented at ASCA this year with their CCR8 antibody in combination with toripalamide. With the selectivity and potency of our own CCR8, we're excited about the potential of our combination which will form the first cohort of a study exploring CHS114 with Tori in additional tumor types, and which we're preparing to open in quarter one next year. For our partnership approaches, the studies utilizing Loctosi previously communicated remain either in startup for both the EMB therapeutic combination in ovarian cancer and the combination in head and neck with Inovio, or ongoing, as with the Junshi-sponsored tori tori alone or observation in limited stage small cell finally we have a very active investigator sponsored program ongoing with much interest of physicians being received for the investigation of tori palamab for ists in head and neck cancer and beyond and with that i'll hand over to brian mcmichael our chief financial officer brian thank you raj and good afternoon everyone

As Denny and Paul shared, it was a strong quarter as we continue to successfully execute on our strategy. Our sharpening focus on oncology is delivering results. Third quarter 2024 revenues were comparable to Q3 2023, despite the divestiture of non-core products with higher gross profit, lower operating expenses, and lower interest expense. This past quarter saw continued savings from reduced expenditures and improved gross margins, primarily driven by these divestitures and lower headcount. Cost of goods sold for Q3 2024 was $20.7 million, down $12 million from third quarter last year. This significant decrease in COGS, coupled with only slightly lower net revenue year over year, led to a 20% improvement in quarterly gross profit, or $8.2 million. R&D expense totaled $21.7 million, a decrease of $4 million or 15% from Q3 a year ago. Savings in R&D were partially offset by investments in our pipeline. R&D expenses for the year reflect significant investments in our commercial products and pipeline candidates related to pre-approval costs for expanding supply chain capacity and redundancy and further de-risking inventory supply through on-shoring manufacturing. SGA expense in Q3 totaled $34.7 million, a decrease of $13.5 million, or 28% compared to the prior year. Interest expense in Q3 was $5.4 million, which reflects a decrease of $4.9 million, or 48% from Q3 last year. The decline was primarily the result of fully paying off our $250 million term loan during the first half of the year, partially offset by interest on our $38.7 million principal amount term loan and our revenue purchase and sale agreement, both commencing May 8, 2024. The Q3 2024 net loss was $10.8 million, or 9 cents per diluted share, compared to a net loss of $39.6 million, or 41 cents per diluted share for the same period in 2023. The non-GAAP net loss was $1.7 million, or $0.01 per diluted share in Q3 2024, compared to $26.9 million, or $0.27 per diluted share in the same period in 2023. Cash equivalents and investments in marketable securities were $97.7 million as of September 30, 2024, compared to $117.7 million at year end. The direct impact of the temporary supply interruption on net revenue will primarily be realized in Q4 earnings, while the impact on cash will primarily lag to Q1 2025 due to payment terms with customers. Today, we are reducing the high end of our expected range of combined R&D and SG&A expenses for 2024, which is now $250 million to $260 million. This guidance includes approximately $30 million of stock-based compensation expense and exclude certain business development activities. With that, I'll turn the call back over to Denny for closing remarks.

Thank you, Brian. Year to date, as we continue to execute on our four-part plan to deliver shareholder value, I want to thank our commercial team for their outstanding results and our manufacturing team for their hard work and progress on our supply interruption issue. While together we have accomplished a lot, there is more to do as we strive to bring innovative therapies to cancer patients and extend their survival. I'm now happy to turn the line open for questions.

Operator? 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. In the interest of time, we ask that you please lend yourself to one question and one follow-up.

Please stand by while we compile the Q&A roster. Our first question comes from Kripa Devarakonda with Truist Securities.

Your line is open. Hello, this is Alex Ksenakosan for Kripa. Congrats on the quarter. We're all excited to see the supply chains getting up and running. I actually have a question on Casdo and Tori in the second line lung. which has gotten some attention. What are your expectations for the trial, given some of the failures that we've seen from some of the competition with some high-profile ADCs in the area have performed as well as some people would have liked? And what's the outlook from your team on seeing responses in both squamous and non-squamous histologies? Thank you.

Great. Thanks for the question, Alex. I'll let Dr. Reischdias, our Chief Medical Officer, Answer that one for you, and then we'll let Dr. LaValley add to it. Raj?

Thanks, Alex, for the question. So for non-small cell lung cancer specifically, I think what we're seeing is that we're building upon some nice data sets that were previously communicated. We have demonstrated that we have seen a couple of monotherapy partial responses. Obviously, that's rare, particularly in PD-L1 refractory subjects. and previously, and also in terms of patients who have less inflamed tumors. So that's a rare observation that we're taking forward and we're encouraged by. The study that we have ongoing right now is a stage design. So we're proceeding very measurably in terms of what we would like to see. The bar in second line is actually pretty low. The standard of care is docetaxel alone, typically, in second line with a pretty low overall response rate. So I think, you know, we're really following the science and we'll see how these results pan out. If we, depending on how we go, we plan to move forward subsequent to this with a phase three study looking at the combination versus the, again, standard of care docetaxel. Teresa, do you have any additional comments?

Yeah, just to add that I think that as we're looking broadly across the lung cancer subtypes, as well as lines of therapy. The responses that were the monotherapy responses were in second and third line. We also have a patient who was on the SURFACE study with kestozaketag in combination with PEMBRO that has had stable disease for over a year. So I think really focusing on that subset where we've seen a signal to limited to second and third line, and squamous really makes a lot of sense. And from a biology standpoint, when we think of the way that Cas Doza Ketad really got IL-27 as a target, became of interest with showing that in response to infection, that IL-27 was important to dampen the immune response in barrier tissues such as lung. The squamous is lung cancer is more akin to an infection since the incidence is more common from smoking, whereas adenocarcinoma is more common due to mutations. So, in these later lines of therapy, it might be a way to really enrich for greater activity. We still think looking earlier in lung cancer, could be also of keen interest across the histology subtypes since IL-27 expression is high across all lung cancer.

Yeah. Thank you, Alex. Thank you. Thank you. Our next question comes from .

Your line is open.

Hi, guys. This is Ashik Anteagal. Thanks for taking my questions. I wanted to ask a couple on the Udenica situation. Can you give us some clarity on when Udenica will be available in the commercial channel again? My understanding is that the production will start this week, but wondering when inventory might see some restocking. And can you give us a sense for how accounts have managed without Udenica? Were they using other products or was there maybe enough products on the shelf at the hospital level where they didn't necessarily feel any particular impact? Nicole, that would be helpful. Thank you.

Thank you. Thank you so much for the question. We're certainly happy to be putting the supply interruption behind this, and I'll let Paul make some comments for you with respect to availability on the shelves and the customers hanging with us. Paul? Yeah, thanks for your question.

So we're expecting know sales to resume in the late november early december time frame so you know we'll have product beginning in our 3pl at that time and then based on the anticipated demand from customers we expect a very robust replenishment in the supply chain to occur over the course of that time late november 3 december and then beyond we also expect customer demand to resume. But as I mentioned, you know, the pace of which, you know, we're going to have to watch as customers start to reintegrate Udenica into the workflows. However, I can tell you that my confidence has been bolstered over the last few days based on the number of conversations that we've had with customers who were using Udenica prior to the supply interruption. and who have given us assurances that they will resume Udenica prescribing as soon as it's available. So I think we're going to start seeing sales coming back again late November, early December with demand accelerating by the end of the year and into 2021. And that confidence by the customers continues to be bolstered by the fact that we've got an innovative and differentiated on-body device We're giving customers the three presentation options, and we've got broad payer coverage. And those three things are of high value to the market. So that demand for Udenica that was there prior to the supply interruption is there today as we come out of that. So we're feeling very, very bullish and confident coming out of this period of time. Now, you asked me about how the accounts managed without Udenica. It's a good question. You know, two ways. Number one, if they were to access product that we had in the channel to be able to bridge them, you know, during that time, then there was really very minimal impact for them. But some accounts may not have been able to access product throughout that entire period. And so they've gone to either back to the innovator if they needed an on-body device, because that's the only product available other than on-body. or they would have gone to a competitive Pegfill Graston brand. But as I mentioned, all indications that we're hearing is that they're going to be coming back to us upon resupply.

Thanks for the thoughtful question. Thanks very much. Thank you.

Our next question comes from Michael Nadelkovich with TD Cowan. Your line is open.

Hi. Thanks for taking my question. I have a follow-up on the CasDozo trial in late-line lung cancer. The docetaxel response rate, especially in early trials and especially in subgroups based on histology, is kind of a moving target. Could you give us a little more detail on maybe a response rate that you think is a good benchmark or maybe a trial that you have in mind as a decent benchmark as it relates to docetaxel and perhaps the threshold that you have in mind for the combo. Thanks. Yep.

Raj, want to take that?

Yeah. Thanks, Michael, for the question. So, you're right. The docetaxel or dosirami is typically the second-line standard of care. Typically what you see, as you say, is around a 12% overall response rate in second line. So we will be looking for an increment over that. I won't go too deep into the stats, but this will essentially be a standard Simon two-stage design. So we'll be, we have certain thresholds that we would like to meet at different stages. But in answer to your specific question, Michael, the baseline docetaxel ORR that we're looking at is around the 12% mark.

Very helpful. Thank you. Thank you.

Thank you. Our next question comes from Douglas Tsao with HCW. Your line is open.

Hi, good afternoon. Thanks for taking the questions. I guess just to follow up on Udenica, I'm just curious, so you'll be selling again at the end of November. At what point do you think you'll be able to meet all demand in the marketplace?

Thanks for your question, Doug. I think that's a great question. we have scheduled some 120,000 units to be produced in five weeks. So that's prior to the end of the year, and I think that's several months' production. So I would say within, oh, three, maybe five weeks, we'll have all this product into the market. So it's moving very quickly on the resupply.

So, Denny, so by the beginning, so while... the fourth quarter will, you know, sort of be, um, obviously impacted by the first quarter. Hopefully you'll sort of be back up and running. And do you think it will take any time given the fact that customers had to come up with sort of contingencies or do you think that, you know, once you get back to, to, to full supply, you'll be sort of, you know, sort of back to normal, so to speak.

Yeah, well, once again, I think that resupplying the channels, in particular the distributors, will be occurring in December, certainly into January. But I'll let Paul come a little further on your follow-up question about just how things shake out going forward from there in Q1. Paul, any thoughts for Doug?

Yeah, thanks for your question, Doug. So the pace of which the demand acceleration will return the prior quarters I think will be ultimately dependent upon decisions that each of the different practices make on how they're going to treat each patient. In other words, if they've had to start a patient on another therapy during the supply interruption, they're going to have to make a decision as to whether or not they're going to switch that patient to Udenica, which requires some operational burden on the account's behalf. They've got to re-verify the insurance, and it requires some work. I think that some accounts have signaled their intention to do that, which means the pace of demand acceleration returning will be faster. I think there's other accounts that are going to just not disrupt the patient's treatment and let them run, and then we'll be getting all new patient stores. So I think those are the dynamics that we're going to be monitoring. Most importantly, just we want to ensure a very smooth and easy transition with each account so that we can get, you know, our demand to be at or even greater levels that we had prior to the TSI.

Thanks, Paul. Doug, I think it's important to keep in mind that Udenica demonstrated six consecutive quarters of growth, including a 30% increase from Q2 over to Q3. And as Paul pointed out, this was largely driven by our very well-differentiated on-body device, our three presentations, and our strong coverage. Those conditions existed before the supply interruption, And they will drive the recovery of our market share after the supply interruption. So as Paul indicated, we're fairly bullish on that. Hard to predict the exact trajectory and acceleration. But these customers are coming back to us.

Have you had any customers that have indicated that they're going to purchase in less volume just as they diversify their supply chain because of the disruption? No. Okay, great. That's good to hear. Thank you.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone. Our next question comes from Brian Chang with J.P. Morgan. Your line is open.

Thanks for taking our call this afternoon. On restocking, do you expect an even restocking across three of your eudanica formulation, or is there a priority given to pre-filled syringe over on-body or vice versa? And I have a quick follow-up.

Paul, you want to take that one?

Sure thing. Thanks for your question, Brian. Yeah, we're going to follow kind of a sequential restocking flow. On-body is going to come in first, followed by pre-filled syringe, then auto-injector. So it'll come in that order and And, of course, now we'll be working with each account, you know, on their ordering for each of the SKU, respectively. So it'll occur sequentially. Once we get past the initial, then everything will be in the channel. It'll be continually resupplied, and then it'll just follow the steady state as prior.

Okay. And that's very helpful. And then maybe just one more on your contingency plan. that you discussed during the shortage. Do you have to reimburse patients who are, who have to switch over to other treatments and, you know, given that they may have to purchase from other suppliers?

Generally, no. Okay. Thank you. Thanks, Brian. Thank you.

This concludes the question and answer session. I would now like to turn it back to Denny Lanphier for closing remarks.

Denny Lanphier Thank you very much, Daniel, and thank you all for joining us today on our call. As you can see, we continue to make very good progress with our Udenica franchise in Q3. We look forward to continuing that on the other side of supply interruption in Q1, and we will keep you updated on all the progress on our IO pipeline, our tumor microenvironment agents, and so on. Lastly, we'll see you at the city. Thank you, Daniel.

This concludes today's conference call. Thank you for participating. You may now disconnect.