Coherus BioSciences, Inc. Price & Performance (CHRS)

And statements about future clinical development progress. 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 about achieving the closing of the U. S. Anika divestiture [indiscernible] that are not discussed in our that are discussed in our press release that we issued today as well as the documents that we filed 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. All 12/31/2024 financial amounts to discussed today have not been audited and are subject to change upon completion of Coherus' audited financial statements for the year ended 12/31/2024 that will be included in Coherus' Form 10 ks which is expected to be filed with the SEC in the coming days.

And now, I'll turn the call over to Denny.

You, Jody, and thank you all for joining us today at Coherus' Q4 and full year 2024 earnings call. Today, I'll provide you with a review of the progress we've made in 2024 and our key objectives. And I'll describe to you the path lies ahead as we focus on maximizing revenues of Lactorazim expanding its indications and advancing our proprietary pipeline combination with like Torzi. On our previous calls, I outlined our four part strategy. To position Coherus for future success in innovative oncology. This included first, to drive top line revenues, second, control the expense line thirdly, to advance innovative pipeline and lastly, to address the debt overhang on our balance sheet. I'm happy to report that over 2024, we have been successful across all these objectives. Support of our overarching strategy. Particularly given last year's strong execution, we are now well positioned in 2025 to complete our strategic transition [indiscernible] a fully integrated commercial stage innovative oncology company. We have addressed our balance sheet debt issue and will put about $250,000,000 in cash on the balance sheet at transaction close. [indiscernible] to continue our development efforts through key data milestone readouts 2025 and 2026. The most significant change for the company the divestiture of the UDENYCA franchise, [indiscernible] I'm happy to report that we have made substantial progress positioning us to complete this transaction in late Q1 or early Q2.

Securities Exchange Commission review Heartscott Regina review and CFIUS review have all been completed or otherwise approved. The shareholder vote and the special meeting are tomorrow.

We are confident that the divestiture will be approved. And believe that such approval will both an endorsement of our overarching strategy as well as an appreciation for the strong execution that got us here. However, it must be said on a more macro level that we are certainly not satisfied with our current stock price.

Post transaction, with the debt overhang behind us, a strong balance sheet and potentially exciting data in front of us, We will focus on enhancing investors' appreciation and understanding of Coiris' value proposition. This will be a key focus of management in 2025 and 2026. Now back to the divestiture. Apart from the shareholder vote, the primary remaining closing condition at this point is the FDA authorization to sell final packaged product from our additional contract manufacturing organization responsible for our labeling and packaging operations. We've made the required submission and believe it fully communicated guidance to us. This final step in our strategic transformation follows a series of over the past two years. [indiscernible] January 2021, we initiated a deliberate four year strategic transformation process with the in licensing of toropelumab our differentiated PD-one inhibitor from June G biosciences. To be a major commercial player in innovative oncology, we believe it is strategic necessity to have an approved proprietary PD-one to anchor an innovative oncology pipeline. Lactorsia is our key foundational asset with both our own pipeline candidates as well as our partners. Driving development synergies as well as sales synergies from proprietary combinations. Lactorzi was launched in Q1 last year and is now standard of care in all lines of nasal pharyngeal cancer.

In September 2023, we acquired a promising pipeline of oncology candidates for through the acquisition of Surface Oncology for a net $40,000,000 inclusive of global rights to a first in class anti IL-twenty seven agent Kastos Okeetag, as well as 14. While these assets were underappreciated at the time, the strong inherent biology and early clinical data convinced us that these are differentiated and potentially game changing. Ideally suited for development in combination with Mike Toresi. That data is rolling out in front of us now particularly in liver cancer with Kastoso and gives us confidence that we were right. And that future data readouts will further validate the clinical utility of these assets.

Having thus secured our innovative oncology future with a promising pipeline, [indiscernible] Last year in 2024, we divested our ophthalmology and HUMIRA biosimilar franchises about $240,000,000 in total consideration and transferred financial obligations. [indiscernible] the UDENYCA transaction closes and things happen as planned, we will divest at least $800,000,000 in assets [indiscernible] paying off $4.00 $8,000,000 in debt, all with an average capitalization of around $175,000,000 Going forward, we're left in good position. With $250,000,000 on the balance sheet a differentiated PD-one enjoying growing sales in a market where standard of care [indiscernible] indication expanding pivotal trials underway for our PD-one funded by others, and a strong pipeline addressing a $15,000,000,000 potential sales opportunity in combination with LectorZY.

And with that, let me now turn it over to my team for more color and details in each of their areas. First, on the commercial side, you'll hear from Paul Reeder, our Chief Commercial Officer. Whose team has done an excellent job with UDENYCA navigating the supply interruption and the subsequent reentry into the market. [indiscernible] Paul's team delivered some strong UDENYCA numbers for us in Q4, all things considered against obvious headwinds. Will also hear today from Sameer Goragalkar, who joined us in Q4 as the new LaCrosse brand lead. Severe is tightly focused on maximizing the potential for the Lactorsi label, NCCN guidelines as well as customer and patient segmentation, which he will discuss with you. Sameer will continue to provide us insights on LaToursi performance on these calls going forward. After commercial, Doctor. Trusz Levalay will discuss our overarching development strategy and Doctor. Raj Dias, our Chief Medical Officer. Will cover our clinical trials and provide additional color on the Evolviex Dozo CHS datasets. Lastly, before we conclude our prepared remarks and go to the question and answer session, Chief Financial Officer, Brian McMichael, will review the Q4 and 2024 annual numbers and deltas for you as well as provide some color on matters going forward.

Without the transaction closed, we will not be guiding on 2025 expenses at this point. But of course we'll do so for you on the Q1 call in May. And with that, I'll hand it over to Paul and Samir for the commercial review. Paul? You, Dane. Good afternoon, everyone. We'll now review brand specific updates starting with UDENYCA. UDENYCA net product sales for Q4 were $46,300,000 increase of 28% compared to 36,200,000.0 for Q4 twenty twenty three. For fiscal year twenty twenty four, UDENYCA net sales were $2.00 $6,000,000 an increase of 62% compared to 127,100,000.0 for fiscal year twenty twenty three. Pleased to report that UDENYCA supply resumed in November with our labeling and packaging contract manufacturing organization. Delivering both backlog and planned lots to restock the distribution channel and begin fulfilling customer demand. In early January, we announced that due to strong demand in Q4 and into Q1 of this year, all three presentations of UDENYCA were being temporarily allocated. Since then, and based on individual wholesaler historical purchasing patterns, supply allocations to wholesalers, and to their end customers, For all three presentations of UDENYCA, we were removed between the January and the February. Customers who represented 97% of UDENYCA volume pre supply interruption have returned to order in UDENYCA. [indiscernible] reinforcing the strength and resilience of the UDENYCA brand and the differentiated delivery presentation options that meet the unique needs of providers and patients.

UDENYCA market share in Q4 was 15% UDENYCA market share in Q4 was 15%. With an exit share of 22%. And we remain confident that customers with demand and market share acceleration throughout 2025. As UDENYCA is the only brand in the pegfilgrastim class that offers three product presentations. A differentiated on body device, and broad payer coverage. Finally, as we move toward the closing of the divestiture, the UDENYCA business the commercial team remains focused on three key priorities: First, driving UDENYCA revenue and market share beyond pre supply interruption levels Second, accelerating long tours in new patient starts which Sameer will discuss momentarily, And third, to ensure that post transaction, we maintain an optimized commercial team. To fully enable continued momentum of our Lactorsy launch and reach the maximum commercial opportunity LOCK TORZI as quickly as possible.

Now to review the LUXORZI business.

I'll turn the call over to Sameer.

Sameer?

Thank you, Paul. I'm happy to join the team. L'OFTRAZI net revenue was $7,500,000 in Q4, a 29% increase quarter over quarter. Net revenue for fiscal year twenty twenty four was $19,100,000 As previously outlined, there are approximately 2,000 lost LOSI eligible MCC patients each year and relapsed locally advanced and first line metastatic patients represent about two thirds of the eligible patient population. NTC in the rare cancer and oncologists typically see one to two new patients per year. Our goal is to reinforce Loporzi as the standard of care in all eligible NTC patients. We remain focused on expanding the breadth of Lactrosa use as well as keeping patients on therapy for as long as appropriate.

Since launch, we have made strong progress towards these goals. Nearly eighty percent of all NCCN institutions have used Logcordsy for at least one patient. In Q4, the number of new accounts purchasing Lactorsi grew by 37%. Loptozi new patient starts also continued to grow in Q4 with uptake primarily in the relapsed locally advanced and first line metastatic setting which is a key driver for long term revenue growth. We reiterate our belief that LOCK TOWZY revenue will follow a steady ramp in the near term fueled primarily by new patient acquisition. Sustained growth over time will be driven by duration of treatment and 80% of long term revenue will come from continuing patients. We estimate that this will take about three to four years to realize the full potential in MPC. [indiscernible] Now regarding Q4, revenue trends were affected by two transient headwinds that impacted Loctorgi's share of voice. The first was UDENYCA temporary supply interruption. Second, the announcement of UDENYCA divestiture and the required field force restructuring comprised an additional impediment This will continue to impact us until the transaction closes customer assignments are finalized, and the field establishes a new territory footprint and customer relationships. However, long term Loftus will benefit from sustained tailwinds beyond closing of the divestiture and we are well positioned for success.

First, in November 2024, NCCN updated NPC guidelines placing LOSC closely in a preferred position for metastatic and locally recurrent NTC patients. [indiscernible] Both our sales team and digital promotions are focused on educating customers on the updated guidelines. Initial customer feedback on the guidelines have been very positive with oncologists telling us they intend to increase the use of oxymorgene in NTC. Secondly, as an innovative oncology commercial organization, the team's singular focus will be on reinforcing LOCKORIZY as the standard of care and preferred treatment for all NTC patients. Given that MPC is a rare cancer, key tactics include leveraging real time data to drive HCP and patient identification, at the time of diagnosis. And we are engaging with key customers to encourage updating of account level MPC pathways and order sets to align with our label and revise NTCN guidelines placing Lactorsig in the preferred position. In short, we will continue to deliver on our track record of strong commercial execution in oncology. In Lopersey, we have a differentiated and highly efficacious drug that has delivered a profound survival advantage and enjoys superior NCCN positioning as a reflective of the strength of our data. We thus expect that LOCKROSI will achieve a dominant market share position in MPC that we estimate to be valued at about $150,000,000 to $200,000,000 In 2025, we are excited to differentiate Lactorsi plus or minus chemo as the only NCCN preferred regimen for metastatic and recurrent NCC patients.

And the only FDA approved PD-one with proven PFS and OS benefits for patients in this space. I'll now turn the call over to Doctor. LaValle, our Chief Development Officer. Teresa?

Thank you, Sameer.

Good afternoon. We are pleased to update you on our continued progress in 2025 with key regulatory and clinical advancements of our promising pipeline focused on our next generation and differentiated PD-one inhibitor for Opalomab. [indiscernible] Lortz et al, recently highlighted that not all PD-one inhibitors are the same in a review article published in the Frontiers and Oncology Journal. The publication highlighted that toripalumab uniquely binds the FG loop of the PD-one vector domain with high potency driven by a very slow off rate.

Clinically, this pharmacology has revealed differentiation by delivering clinical activity in combination with chemotherapy irrespective of PD L1 expression levels. In multiple Phase three studies. The European Health Authorities recently approved torapalumab for first line esophageal squamous cell carcinoma irrespective of PD L1 expression. And in contrast, has recently been approved for first line esophageal squamous cell carcinoma. Only for patients whose tumors express PD L1. The U. S. FDA also recently highlighted the lack of activity of pembrolizumab nivolumab and tizolizumab and PD L1 low patients. And this indication and gastric cancer in an ODAC meeting last September. Toripalibab differentiation and potency positions us well as we look to in combination with novel agents. Our strategy for expanding toripalumab indications beyond MPC in The U. S. Is focused on drug supply collaboration where we evaluate toripolumab with novel mechanisms both with early and late stage compounds and prioritized tumor types such as head and neck and lung cancer and clinical trials. And internal development efforts on our pipeline of potent and selective antibodies positioned in tumor types with strong biologic rationale to establish proof of concept. Importantly, for each clinical indication that advances casdosedicate TUD, or CHS-one hundred and fourteen into a pivotal study It also advances torapalumab into a potential new indication.

From a regulatory perspective, we are progressing to plan with establishing all our drug manufacturing in The United States. Coherus has always focused on The U. S. For development and commercial including Dayton America manufacturing. The clinical trials for casdosed akituz a IL-twenty seven antagonist in CHS-one hundred and fourteen a cytolytic CCRA antibody, are designed to deliver data this year to address the FDA's Project Optimus and enabling favorable regulatory strategies to advance development pending positive data into pivotal studies in 2026 and 2027. I'll now turn the call over to Doctor. Daez to discuss the clinical development and pipeline data.

Raj?

Thank you, Theresa, and good afternoon. Over the next few minutes, I'll focus on the progress of the combination studies of our competitively well positioned assets CASTOS KeyTUG and CHS-one hundred and fourteen in combination with the toripalumab backbone, which forms the foundation of our internal development strategy. With regards to Castovo, our first in class IL-twenty seven targeting antibody, Our two areas of current focus are in non small cell lung cancer and hepatocellular carcinoma. For non small cell, our ongoing program builds upon the monotherapy response as demonstrated in previously treated PD L1 refractory squamous cell histology in less inflamed tumors most recently presented at ESMO IO in December 2024. Our combination study of castosa with toripalumab continues to guide us to focus on squamous cell histology our future focus will be. [indiscernible] Dates from the ATEZO, BEV, CASDOVA triplet combination study was first presented mid-twenty twenty three and the final data was recently presented at ASCO GI in January 25. During this time period, overall response rate has increased from twenty seven percent to thirty eight percent reflecting an increase in response rate over time. Additionally, the complete response rate has also increased from zero CRs initially to five CRs in the most recent data set, representing a 17% complete response rate, which reflects a deepening of response also.

These figures compare favorably with current treatment benchmarks in particular as the prior Phase three studies in HDC IN BRAVE150 and Himalaya have reported CRA between three percent and eight percent. And importantly, the increase in response rate and the deepening of responses over time is very encouraging as we move forward with our ongoing development program where we have switched out ATEZO for our own PD-one toripolumab The three arm tori, BEV, Kasto, the combination study in first line HCC is active and ongoing. And randomized a total of 72 subjects to explore two dose levels of COSDOZO in combination with ToriBeV At the same time aiming to provide us with a strong body of evidence to set us up for further development in Phase twothree in this indication. Our previously reported data has demonstrated activity irrespective of viral and non viral etiology, which is important as our ongoing study includes sites globally where HCC historically has had varied etiologies. We anticipate having dates from our ongoing triplet study in the first half of twenty twenty six. With regard to 14, our CCR8 cytolytic antibody, our programs continue to progress in both head and neck squamous cell carcinoma and gastric cancer.

As a reminder, our Phase one program focusing on head and neck is in four cohorts to successfully position us for further development. Firstly, monotherapy dose escalation across advanced solid tumors Secondly, monotherapy dose expansion of two dose levels of CHS in head and neck. And with paired biopsies look at tumor biology. Thirdly, combination dose escalation of TORI and CHS-one hundred and fourteen in head and neck And fourthly, further combination dose expansion of TORE plus CHS-one hundred and fourteen in head and neck cancer to a total of 40 subjects. We have now completed accrual in the first three cohorts of the study. We previously presented the data from the first monotherapy dose escalation cohort at ASCO last year. Which demonstrated an acceptable safety profile with no DLTs peripheral CCR8 positive Treg depletion. And a disease stability rate of forty seven percent in very heavily pretreated patients. We will report safety, early efficacy and tumor biomarker data on the second and third head to neck cohorts of study in the first half of this year. The fourth cohort of the study, the combination dose expansion cohort of TORE plus CHS in second line head and neck is open and ongoing.

For gastric cancer, we remain on track to open our global dose expansion Phase 1b study in second line gastric gastroesophageal esophageal adenocarcinoma this quarter to build upon the encouraging Tori CCRA data presented at ASCO24 in this indication. And anticipate data from this study to be available in the first half of twenty twenty six. With that, I'll hand over to Brian. Brian?

Thank you, Raj, and good afternoon, everyone.

Today, I will cover the fourth quarter and annual results and provide an overview of Coherus' transition culminating with the expected divestiture of UDENYCA, sets the company up for focus and execution solely on oncology. I will start with COGS since Paul and Samir already covered revenue. Cost of goods sold decreased $159,000,000 in full year 2023 one hundred and eighteen million dollars in 2024. The change was primarily driven by $56,900,000 lower COGS from the divested product similarly and $32,900,000 lower net inventory write offs. Partially offset by increased volumes of our oncology products.

COGS of $33,900,000 in the fourth quarter twenty twenty four reflected the impact during the quarter from temporary supply interruption of UDENYCA, and includes a $12,000,000 charge for the write down of UDENYCA inventory that did not meet [indiscernible] COGS in Q4 twenty twenty three was $84,600,000 and includes a $47,000,000 charge related to slow moving Yosemite inventory and slow moving, you summary inventory. Turning to OpEx. Total 2024 GAAP R and D and SG and A was $261,000,000 Comparisons of the full year 2024 and the fourth quarter to the same periods in the prior year reflect decreases in both R and D and SG and A as to savings driven by lower headcount, and lower cost due to biosimilar divestitures in the first half of twenty twenty four. Specifically, research and development expense decreased 15% to $93,300,000 in 2024 and down from $109,400,000 in 2023, and was $21,200,000 for the fourth quarter twenty twenty four, down 19% from $26,400,000 in the prior year. The decreases were primarily driven by factors mentioned earlier partially offset by increased investments in our pipeline in 2024. SG and A expenses decreased 13% or $167,000,000 to $167,700,000 in 2024, down from $192,000,000 in 2023.

The fourth quarter twenty twenty four SG and A totaled $41,300,000 which includes $6,700,000 in divestiture related transaction costs. It was down 17% from $49,500,000 in Q4 of the prior year. The decreases were primarily driven by the factors mentioned earlier. I'm pleased to report that interest expense in twenty twenty four was $27,200,000 down 33% from $40,500,000 in the prior year and $5,300,000 in Q4 twenty twenty four. Which is about half what it was in 2023. Decrease decreases were primarily from paying off our $250,000,000 term loan in the first half of the year. We ended the year with $126,000,000 in cash and cash equivalents. Denny talked about the progress on the Identica divestiture so I'd like to provide you a view on our post transaction projections. [indiscernible] expect headcount to reduce by 30% approximately two twenty five employees including 50 employees transferring to the buyer in the divestiture. Substantial majority of the company's off balance sheet firm purchase commitments related to UDENYCA will also transition to the buyer. As previously disclosed in our filings, we expect to use tax attributes to offset all but a minor part of the gain on the transaction. Immediately following the transaction, close, which is projected late this quarter or early next quarter, expect to have $250,000,000 in cash on the balance sheet.

This amount is net of the expected payoff of $230,000,000 convertible note as well as a $48,000,000 projected payoff of UDENYCA royalty obligations.

We expect this cash combined with collections from Edenica receivables net of related charge backs rebates and other fees as of the divestiture close date, as well as proceeds from La Corzi's expecting growing revenues, and reimbursements from the transition service agreement with the buyer to last beyond two years. Hand the call over to Denny.

Thank you, Brian. Operator, that concludes our prepared remarks. We're happy to go to the Q and A session.

Thank you so much. And it's from Sri Kripa De Barraconda with Truist Securities. Please proceed.

Hey guys. Thank you so much for taking my question. With the shareholder voting tomorrow, just wanted to check if there are any hurdles at all that we can expect like make sure there are no surprises with respect to the UDENYCA divestiture Also you noted you expect to have $250,000,000 in cash exceeding two years. Does that include the cost savings from the headcount reduction by 30%? And that 30% coming from those associated with UDENYCA? Or is there any other optimization in terms of expenses? And then I have a follow-up question.

Thanks for your question, Krimpa. With respect to the divestiture we see no obstacles or impediments in the way of concluding that. We feel that the investors are very supportive of both the execution of the company over the past year or so as well as the reposition of the company strategically And we have also, as I outlined in my completed SEC reviews, CFIUS, RSCOT, Regino and so on. So the only remaining I would say the primary remaining issue is the authorization from FDA to begin selling the material from the new contract.

Manufacturer. And we do not believe that was an impediment either. So we believe that it's pretty much going forward as planned.

With respect to the two years of savings and so on and the 30% headcount reduction, I'll let Brian McMichael, my CFO, give you some additional color. Sure. Thanks. Kripa for the question. So the $250,000,000 if you the way to get to that number is if you look at our cash as of the end of the year, it was $126,000,000 The upfront consideration on the transaction is $483,000,000 and then we expect to pay off the $2.50 $30,000,000 convertible note [indiscernible] dollars 48,000,000 in royalties, And then you have some other cash flows related to fees and just during Q1. And so the $250,000,000 represents what we expect cash to be be as of the or immediately following those transactions.

None of those deductions. And what about going forward with the headcount reductions of the savings? [indiscernible] going forward, what you can expect is, as we mentioned, we have around two twenty five employees as of as of now. And we expect to get that down to 155 employees. 50 of those employees we expect approximately to transfer to [indiscernible] and the rest will work out over the coming coming year. Thank you, Krippa. Did you have a follow on question?

Yes.

I was just wondering about LOCK TURSEY. I think you have the NCCM guidelines, you have preferred position for LOCK TURSEY because Congratulations on that. I was just wondering if you have a sense of where the drug is being used now, now that you have both frontline and second line in guidelines? Thanks.

Thanks for that. Maybe Samir has a few comments and color he can provide on that.

Samir?

Yes, sure, Denny. So let me give you a little bit of historical context, right? The previous guidelines put us on the previous guidelines, there were multiple treatment options including chemo alone, chemo plus other off label IOs and chemo plus block early. So as a result of that, we believe that fuels the extensive use of chemo only and chemo plus off label IO that was happening in the marketplace, right? Going forward, what we've seen is that the guidelines are very clear about recommending chemo plus docility as the preferred treatment for first time metastatic patients and recurrent patients as well. We've talked to a lot of physicians and market research and what we've heard is the guidelines have been very well received Physicians tell us they are expecting to increase the use of BLOCKTROZY. And it's really specifically about your question where it's being used right now. It's a mix of recurrent locally advanced patients metastatic first line patients. And also we have some second line metastatic patients, but primarily majority of patients are right now receiving therapy in the more more early lines of therapy. So we have a mix of patients right now. And we expect that to continue because of the broadness of our label.

Thank you.

Okay. Thank you so much.

Thank you. One moment for our next question, please. It comes from Yigal Nokomovit with Citigroup. Please proceed.

Hi, Denny and team. Thank you. Just on the labeling and packaging for the second supplier, what exactly is the FDA looking to check the box on there to give you clearance to go through with the transaction? [indiscernible] the FDA required that we did certain test runs and validation runs with the new line. The new line required installation of certain equipment. And so whenever you spool up an additional manufacturer, even though it may be like to like, whatever, you have to actually perform runs and make sure that the equipment is working. And so we first of all had conversations with the FDA establishing how many runs they needed, how many units per run and so forth. The new contract manufacturer then went off and did that. And completed the required validation protocols. And then we went ahead, reviewed that and then submitted it. So we think that it's relatively straightforward. And we expect probably over the next month or so we will hear from the FDA regarding that.

Okay. So they don't need to visit the facility, they just need to sign off on that data. Is that correct?

No, they do not need to the facility. Only need to review the data, correct.

Okay.

Got it. And on on the CCRA, actually, I was curious, you have fairly specific timing, second quarter twenty twenty six for the the Tori combo, and then the Phase Ib study in second line. Gastric, Could you just comment on how you're able to arrive at such a specific timing, not more than a year away? For that study? Thanks.

I think that I'll let Raj give you a little more color on that, Ygal. I think the shorter answer is that we have making very good progress [indiscernible] respect to enrolling the patients and splitting them up we're also dealing with a contract research organization that we have a very strong history with. That's put a strong team on the product. Rosh, any further color for you go?

I'll just hi, Gil. Thank you for the question. So just two or three additional costs.

So first of all, you'll recall we already the study is multiple parts. So we've already reported the initial data set, so we have good site engagement from there. The second piece is that we will have more additional data from the second and third part of the HELLO NEXT study this year.

And then for the expansion, as you quite rightly say, we anticipate [indiscernible] towards the end of the first half of next year.

And I think if you look at several of our studies, we have very good site engagement, very good engagement with physicians, And we also for the gastric study in particular, it's a global study So I think our feasibility has been pretty tight and we have really engaged the right sites which have these patients. So our projections are fundamentally based on [indiscernible] projections.

The other comment that I would offer you, Ygalith, that management reviews these regularly. We just had another review in this last week. So we realized the importance of getting the data in a timely fashion. We're quite focused on it. And I think [indiscernible] one of our strong points. So happy to keep you informed.

Okay.

Thanks. Last one quickly on Latorzi, did you take a price increase? And if so, what was the percent?

Yes, that's great. Samir, would you like to comment for your on the pricing?

Yes, I'll take that high you go Yes, we did take a price increase It was around 2.46%.

Okay.

One moment for our next question, please.

And it comes from the line of Collyn Kossi with Baird. Please proceed. Good afternoon. Thanks for taking our questions and congrats on the progress For the head and neck cancer data, in the first half of this year, can you just kind of help us set expectations on what to expect there? How many patients and how much follow-up. Hey, Carlene, thanks. Raj, do you want to give a little color to Carleen?

Yes, absolutely. Hi, Carleen. So yes, we're expecting we will be reporting out data in the first half of this at one of the major conferences from part a little bit of data from part first part also more data from the second and third part. So essentially, all in all, we'll have around thirty, thirty five patients. Worth of data. And what you should expect is safety, early efficacy and also we've got some intratumoral biomarker data as well that we anticipate presenting as well.

Great. And then for the KASDOSO ORI combo in second and fourth line non small cell lung cancer, Can you just kind of help us set expectations for that data readout as well, please? Yes. So we'll have emerging data as we move through the year. I'm not going to comment too much on specific enrollment and results because we still do have subjects who are still on therapy the stage one of the two stage CYMA-two stage design. But what I will say is that we anticipate focusing in on squamous specifically moving forward, which is of course, as you know, Killeen, where we have seen our signal thus far. [indiscernible] Thank you.

Our next question is from Michael Nadelkovich with TD Cowen. Please proceed.

Hi, thank you for the question. I have one as it relates to the Chazdozo development plan in non small cell lung cancers. So it sounds like you're moving forward in squamous. I was just curious what is the next step Is it a randomized Phase two Is there any chance you could move to a pivotal in late line non small cell lung cancer And what is contemplated in your cash runway guidance as it relates to CASDOZO development in lung cancer? Thank you.

Hi, Michael. So I'll take the first part of that question. So, and [indiscernible] a robust data set in the combination of toripalumab with Kedosa, in non small cell. As I say, the future focus for that is likely to be on squamous cell. We'll then move on into into a Phase twothree. So the Phase three study will be a standard Phase three and will against the current standard of care, which is docetaxel. And we talked a little bit last time about the response rates that one sees typically with dosedexol. And while I won't comment on what exactly we what bar we're expecting to see, you know what the dose tax or overall response rates are. So So the subsequent Phase three study will be again, again, second of care dose tax or Regarding funding of the Phase III, that's not within the window of the two year guidance that we have gone up so far. I think there's a number of options to proceed with that given the data. And I would also indicate that out three to four years during that such time, we think that we have toropelumab pretty much at full force in the nasal pharyngeal cancer space with $150,000,000 to $200,000,000 Thank you.

Thank you.

One moment for our next question. That comes from the line of Brian Cheng with JPMorgan. Please proceed.

Hey, guys. Thanks for taking my questions this afternoon.

Maybe first one is for Paul. On LOCKORSUV, can you give us a sense of the stickiness to the product in the real world? And for those doctors who have been using KEYTRUDA off label in MPC in the past, I'm just wondering if you can talk a little bit more about their current level of awareness and also willingness to adopt La Torzi?

Yes. Well, thank you for question on that, Brian. I think some American probably provide you a little color on that.

Yes. So let me start with the question about the stickiness of Lacturia, right? So what we've seen is the dilutions who have used Loporgy since launch have been very satisfied with Loporgy. And they've been advocating on behalf of LOCKROGY. So we expect that they will continue to have repeat use of Block forty. The thing is, this is a rare cancer, so physicians don't see more than one to two new patients every year. So by the time a physician who's used Lactorgy, by the time they have an opportunity to use it again, it's going to take some time. But again, we want to we feel confident that we will get repeat use within our physician population. Now regarding KEYTRUDA, right, there is a significant amount of off label use of KEYTRUDA Part of it is driven by lack of awareness in the community about Loptozi and the data from Loptozi and we are overcoming that very actively by engaging with physicians and explaining to them the data and the NCCN guidelines. I'll say this, every time we have a conversation with a physician about our data or NCCN guidelines, it is very well received. And people get pretty excited about it.

So we feel confident that we will be able to overturn the ongoing off label use of Optorgy especially considering that we're the only PD-one that has any data in this space.

So yes, we're very excited and confident moving forward about making inroads into the KEYTRUDA business as well as the KEYMA only business. Thanks, Brian. Did you have a follow-up?

Yes. And then maybe just one quick one.

Related to the Phase one CCRA toric combo data sometime later this year. I just want to get a better sense of what we should expect from the intratumoral biopsy data Specifically, what would be considered good data that you view us for the supportive for your ongoing work in head and neck Great question. Maybe Doctor. LaValle can handle that one for you. Teresa?

Yes, Brian, thanks for the question. [indiscernible] There are a couple of things we're looking for. First, we've shown robust depletion of CTRA positive Tregs in the periphery that sustained over the dosing cycle want to be able to see that in the tumor Secondly, what's been demonstrated in preclinical models is that removal of the immune suppressive cell, the CCR8 plus Treg there's a broad infiltration of CD8 T cells. So that ratio of immune suppressive to immune activating cell is very important. And a number of studies with PD-one and CTLA-four have been done and shown efficacy is associated with high CD8 T cells in the tumor. After treatment. So we're looking for an increase [indiscernible] in the CD8 cells to tip the balance to immune [indiscernible] Got it. Thank you so much.

Thank you, Trina.

Thanks, Brian.

Thank you. Our next question is from Doug Lutz Tsao with H. C. Wainwright. Please proceed. Douglas, your line is open.

Sorry about that. I was on mute. My apologies.

Thanks for taking the questions and congrats on the progress. I guess just one follow-up for me. I'm just curious in terms for LaTorazzi and the MPC market, how much continued use is there off label IO agents given with the NC and N guidelines out there now And how long do you think it will take for you to sort of capture all that volume Thank you. Thanks, Doug. So your question is how much off label other PD-1s without label and how long will it take us before we really embed lactoresis as Tamara. Sameer?

Yes. And maybe what are some of the things that you need to do to have that happen?

Great. Got it. Moving. So our business opportunity is divided between the academic and [indiscernible] In the academic setting, there's a pretty good awareness especially the head and neck cancer specialists, there's a pretty good awareness of the guidelines and the data for optorgy. In the community setting, all of these physicians are seeing lots of different cancer types. And NTC is not top of mind until they actually see a patient. And as I mentioned earlier, they're seeing one to two patients per year. So it's only top of mind when they see a patient. So we are very actively working on using data to identify physicians at the time of diagnosis of a new patient So we're having a discussion with them about our data and about the NCCN guidelines at a time when they're thinking about NCC. So really the answer to your question is going to be an ongoing process. We did some market research recently and there's about a 40% awareness of the NTCN guidelines Clearly, we want to change that. We want to drive a much higher awareness of the NCCN guidelines. But it will be a steady ramp of the awareness and also the uptake of Loporgy.

Last thing I'll say is just reiterate what I said earlier. When we do have a conversation with a physician who is thinking about NTC, it resonates really well and they get excited about our PFS OS data and the guidelines.

And I guess just as a follow-up, I mean, do you anticipate it being [indiscernible] sort of easier task in the academic centers than is it Is it the community where you have more work to do?

Yes, I think we have to be we can't just focus on the academic centers. We obviously want to get all the academic centers on We want to drive usage in hospital setting. But we want to establish ourselves as a pain of care there's a lot of NPC use treatment of NPC in the community. So we have to make inroads into the community. And we are committed to doing that both through our sales force but also through digital channels. So we've got to be successful in both those settings. Okay, great. Thank you. Thanks Doug.

And thank you.

And this concludes our Q and A session. I will turn it back to Lanier for his final comments.

Thank you, operator. And thank you all for joining us today. As Coherus achieves I should say, is about to achieve really a very strategic milestone assisting the company as a commercial stage innovative oncology company with an excellent product entoropelmat a very, very promising pipeline. We will be at IO three sixty later this month in Boston. And look forward to seeing you all there. Thank you very much.

And thank you all for participating in today's conference. You may now disconnect. [indiscernible] [indiscernible]