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Coherus BioSciences Inc. reported its earnings for the fourth quarter of 2024, revealing a better-than-expected revenue performance. The company posted a revenue of $54.1 million, surpassing the forecast of $44.15 million. The earnings per share (EPS) stood at -$0.28, slightly better than the anticipated -$0.30. Following the announcement, Coherus BioSciences’ stock experienced a modest increase in after-hours trading, rising by 0.93% to $1.05. According to InvestingPro data, the company has shown impressive revenue growth of 44.19% over the last twelve months, though it remains unprofitable during this period.
Key Takeaways
- Coherus BioSciences exceeded revenue expectations for Q4 2024.
- EPS was slightly better than forecasted, reflecting improved financial performance.
- Stock price increased by 0.93% in after-hours trading.
- The company is undergoing significant strategic shifts, including divestitures and headcount reductions.
- Lactorzi sales showed strong growth, reinforcing its market position.
Company Performance
Coherus BioSciences showcased a robust performance in Q4 2024, driven by strong sales of its key products. The company is actively transitioning to focus on oncology, having divested several franchises and reduced its workforce. The strategic shift aims to position Coherus as a leader in innovative oncology treatments.
Financial Highlights
- Revenue: $54.1 million, exceeding the forecast of $44.15 million.
- EPS: -$0.28, slightly better than the forecast of -$0.30.
- UDENYCA net sales for Q4: $46.3 million, up 28% year-over-year.
- Lactorzi net revenue for Q4: $7.5 million, up 29% quarter-over-quarter.
- Cash and cash equivalents: $126 million at year-end, expected to reach $250 million post-divestiture.
Earnings vs. Forecast
Coherus BioSciences reported a revenue surprise of approximately 22%, with actual revenue of $54.1 million surpassing the forecasted $44.15 million. The EPS of -$0.28 was slightly better than the expected -$0.30, indicating a minor positive deviation from analyst expectations.
Market Reaction
Following the earnings announcement, Coherus BioSciences’ stock rose by 0.93% in after-hours trading to $1.05. This movement reflects investor optimism about the company’s strategic direction and financial performance. The stock’s current price remains within its 52-week range of $0.66 to $2.64. InvestingPro analysis indicates the stock is currently fairly valued, with analyst price targets ranging from $1.50 to $8.00, suggesting potential upside. Discover more insights and 5 additional ProTips about CHRS with an InvestingPro subscription.
Outlook & Guidance
Coherus BioSciences is focusing on expanding Lactorzi’s market presence and advancing its oncology pipeline. The company anticipates clinical data readouts in 2025-2026 and is targeting Phase 3 studies in non-small cell lung cancer. While Coherus expects to maintain a two-year cash runway, InvestingPro data shows the company operates with a significant debt burden of $269.88 million and a current ratio of 1.25. Get access to the comprehensive Pro Research Report covering CHRS and 1,400+ other US stocks for deeper financial insights and expert analysis.
Executive Commentary
"We are now well positioned in 2025 to complete our strategic transition to a fully integrated commercial stage innovative oncology company," stated Denny Lamphere, CEO. Sameer Goregelkar, SVP Marketing, emphasized, "Our goal is to reinforce Lactorzi as the standard of care in all eligible MPC patients."
Risks and Challenges
- The success of strategic divestitures and their impact on cash reserves.
- Potential market competition for Lactorzi and other oncology products.
- Execution risks associated with ongoing clinical trials and regulatory approvals.
- Economic pressures that could affect healthcare spending and product adoption.
Q&A
During the earnings call, analysts inquired about the progress of the UDENYCA divestiture and strategies for Lactorzi adoption. Executives confirmed the divestiture is on track and discussed ongoing efforts to engage with physicians to increase Lactorzi’s market penetration.
Full transcript - Coherus BioSciences Inc (CHRS) Q4 2024:
Carmen, Conference Operator: Please be advised that today’s conference is being recorded. Now it’s my pleasure to turn the call over to the Head of Investor Relations, Jody Sievers. Please proceed.
Jody Sievers, Head of Investor Relations, Coherus Biosciences: Thank you, Carmen. Good afternoon, and welcome to Coherus Biosciences’ fourth quarter and full year twenty twenty four 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 Doctor. Raj Dias, Chief Medical Officer Doctor. Teresa LaValle, Chief Development Officer and Samir Gorygaukar, Senior Vice President of Immuno Oncology Marketing.
Before we get started, I would 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: projections about future revenues, headcount reductions, statements about our ability to satisfy the closing conditions of the UDENYCA divestiture, statements about the use of proceeds from the UDENYCA divestiture and our projected future cash and cash runway 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 UDENYCA divestiture 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 statements.
All 12/31/2024 financial amounts 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 K, which is expected to be filed with the SEC in the coming days. And now, I’ll turn the call over to Denny.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thank you, Jody, and thank you all for joining us today on Coherus’ Q4 and full year twenty twenty four 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 with Lactorzi, expanding its indications and advancing our proprietary pipeline combination with Lactorzi. 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 revenue second, control the expense line thirdly, to advance the 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 in support of our overarching strategy.
Particularly given last year’s strong execution, we are now well positioned in 2025 to complete our strategic transition to 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 to continue our development efforts through key data milestone readouts in 2025 and 2026. The most significant change for the company is the divestiture of the UDENYCA franchise. And I’m happy to report that we have made substantial progress positioning us to complete this transaction in late Q1 or early Q2. Securities and Exchange Commission review, Hart Scott 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 constitute 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 at 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 Coerus’ 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 vinyl package product from our additional contract manufacturing organization responsible for our labeling and packaging operations. We’ve made the required submission and believe it fully conforms with In
Unidentified Speaker: January
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: In January 2021, we initiated a deliberate four year strategic transformation process with the in licensing of torapalumab, our differentiated PD-one inhibitor from Jun Chi 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. Lactorsy is our key foundational asset and will be used in combination with both our own pipeline candidates as well as our partners, driving development synergies as well as sales synergies from proprietary combinations. Lactrosy 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 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, Gastosoketu, as well as a highly selective cytolytic CCRA antibody, CHS-one 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 MYCORZI. That data is rolling out in front of us now, particularly in liver cancer with KASDOSO 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, last year in 2024, we divested our ophthalmology and HUMIRA biosimilar franchises for about $240,000,000 in total consideration and transferred financial obligations. Over this past year, assuming the UDENYCA transaction closes and things happen as planned, we will divest at least $800,000,000 in assets or commitments, paying off $480,000,000 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 it’s standard of care, 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 Lectorazine. 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 in navigating the supply interruption and the subsequent reentry into the market. Paul’s team delivered some strong UDENYCA numbers for us in Q4, all things considered against obvious headwinds. You will also hear today from Sameer Goregelkar, who joined us in Q4 as the new Lactourzi brand lead. Sameer is tightly focused on maximizing the potential for the Lactourzi label, NCCN guidelines, as well as customer and patient segmentation, which he will discuss with you. Sameer will continue to provide his insights on Lantorozi performance on these calls going forward.
After commercial, Doctor. Trusula Valli will discuss our overarching development strategy and Doctor. Ashdaias, our Chief Medical Officer, will cover our clinical trials and provide additional color on the Evolvie, Esdozo and CHS-one hundred and fourteen 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 Sameer for the commercial review. Paul?
Paul Reeder, Chief Commercial Officer, Coherus Biosciences: Thank 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 an increase of 28% compared to $36,200,000 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 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 were removed between the January and the February. Customers who represented 97% of UDENYCA volume pre supply interruption have returned to ordering UDENYCA 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% with an exit share of 22%.
And we remain confident that customers will continue prescribing UDENYCA 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 forward the closing of the divestiture 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 towards the 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 LOCKTORZI launch and reach the maximum commercial opportunity for LOCKTORZI as quickly as possible.
Now to review the Lactorsi business, I’ll turn the call over to Sameer. Sameer?
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: Thank you, Paul. I’m happy to join the team. Lactorsi net revenue was $7,500,000 in Q4, a twenty nine percent increase quarter over quarter. Net revenue for fiscal year twenty twenty four was $19,100,000 As previously outlined, there are approximately two thousand Loptrusi eligible MCC patients each year and relapsed locally advanced and first time metastatic patients represent about two thirds of the eligible patient population. NCC is a rare cancer and oncologists typically see one to two new patients per year.
Our goal is to reinforce Lopcorzi as the standard of care in all eligible MPC patients. We remain focused on expanding the breadth of Lopcorzi 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 Lactorsy for at least one patient. In Q4, the number of new accounts purchasing LOPTORZI grew by 37%.
LOPTORZI new patient starts also continue 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 Loprogy 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. Now regarding Q4, revenue trends were affected by two transient headwinds that impacted Lactobie 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 opportunities will benefit from sustained tailwinds beyond closing of the divestiture and we are well positioned for success. First, in November 2024, NCCN updated NCC guidelines placing long term in a preferred position for metastatic and locally recurrent NCC patients.
Both our sales team and digital promoters 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 Loptozy in MPC. Secondly, as an innovative oncology commercial organization, the team’s singular focus will be on reinforcing Loptozy as the standard of care and preferred treatment for all MPC 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’re engaging with key customers to encourage updating of account level MTC pathways and order sets to align with our label and revise MTCN guidelines placing Lactorsy in the preferred position.
In short, we will continue to deliver on our track record of strong commercial execution in oncology. In Loporzi, we have a differentiated and highly efficacious drug that has delivered a profound survival advantage and enjoyed superior NCCN positioning as a reflective of the strength of our data. We thus expect that LAPOCROSI 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 Lopcorzi plus or minus chemo as the only NCCN preferred regimen for metastatic and recurrent NDC patients and the only FDA approved PD-one with proven PFS and OS benefit for patients in this space. I’ll now turn the call over to Doctor. LaValle, our Chief Development Officer.
Theresa?
Teresa LaValle, Chief Development Officer, Coherus Biosciences: 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 a palimab. Lortz et al. Recently highlighted that not all PD-one inhibitors are the same in a review article published in the Frontiers in Oncology Journal.
The publication highlighted that torapalumab uniquely binds the F2 loop of the PD-one ectodomain 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, tislelizumab 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, enticelizumab and PD L1 low patients in this indication and gastric cancer
Unidentified Speaker: in
Teresa LaValle, Chief Development Officer, Coherus Biosciences: an ODAC meeting last September. Toropelumab’s differentiation and potency positions us well as we look to expand into additional indications in combination with novel agents. Our strategy for expanding torapalumab indications beyond MPC in The U. S. Is focused on drug supply collaboration where we evaluate torapalumab with novel mechanisms both with early and late stage compounds and prioritize tumor types such as head and neck and lung cancer in 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 Kastuzaketan 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 made in America manufacturing.
The clinical trials for cazdosa keto, a IL-twenty seven antagonist and 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. Dias to discuss the clinical development and pipeline data. Raj?
Raj Dias, Chief Medical Officer, Coherus Biosciences: 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, KASDOPEK and CHS-one hundred and fourteen in combination with the toripelumab backbone, which forms the foundation of our internal development strategy. With regard to Cazdoso, 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. The non small cell, our ongoing program builds upon the monotherapy responses 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 CALDOSA with taurepelumab continues to guide us to focus on squamous cell histology where our future focus will be.
The first line is about cellular carcinoma, data from the ATEEZO, BEV, CASDOZA triplet combination study was first presented mid-twenty twenty three and the final data was recently presented at ASCO GI in January 2025. 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 dataset 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 III studies in HDC, IMBRADE150 and HIMILAYA have reported CR rates between 38%. 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 toripalumab.
This three arm taured, verif, casters, a combination study in first line HCC is active and ongoing and randomized a total of 72 subjects to explore two dose levels of CASDOVO in combination with TORIBEV versus the TORIBEV doublet to address Project OPTIMIS whilst 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 CHS-one hundred and fourteen, our CCRA 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 hair 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 with paired biopsies to look at tumor biology. Thirdly, combination dose escalation of tauRe and CHS-one hundred and fourteen in head and neck and fourthly, further combination dose expansion of tauRe 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 CCRA positive Treg depletion and a disease stability rate of forty seven percent in very heavily pretreated patients.
We will report safety, early efficacy and intra tumoral biomarker data on the second and third head and neck cohorts of the study in the first half of this year. The fourth cohort of the study, the combination dose expansion cohort of taurine plus CHS-one hundred and fourteen 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 and esophageal adenocarcinoma this quarter to build upon the encouraging tau CCRA data presented at ASCA24 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?
Brian McMichael, Chief Financial Officer, Coherus Biosciences: 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 Sameer already covered revenue. Cost of goods sold decreased $159,000,000 in full year 2023 to to $118,000,000 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 acceptance criteria. COGS in Q4 twenty twenty three was $84,600,000 and includes a $47,000,000 charge related to slow moving Ucimori inventory and slow moving Ucimori inventory excuse me. 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 due to savings driven by lower headcount and lower costs 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, 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 and 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 2024 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. The decrease the 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 UDENYCA divestiture, so I’d like to provide you a view on our post transaction projections. We expect headcount to reduce by 30% from approximately two twenty five employees, including 50 employees transferring to the buyer in the divestiture. The substantial majority of the company’s off balance sheet firm purchase commitments related to Utenica 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, we 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 UDENYCA receivables net of related chargebacks, rebates and other fees as of the divestiture close date, as well as proceeds from La Porzies expecting growing revenues and reimbursements from the transaction transition service agreement with the buyer to last beyond two years. With that, I’ll hand the call over to Denny.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thank you, Brian. Operator, that concludes our prepared remarks. We’re happy to go to the Q and A session.
Carmen, Conference Operator: Thank you so much. And it’s from Shriekripa Devarackonda with Truist Securities. Please proceed.
Unidentified Speaker: Hey guys, thank you so much for taking my question. With the shareholders 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.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thanks for your question, Kripa. 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 prepared remarks, completed SEC reviews, CFIUS, Harv Scott, Rudino 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 independent 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.
Brian McMichael, Chief Financial Officer, Coherus Biosciences: Sure. Thanks, Crippa, for the question. So the $250,000,000 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 $250,000,000 2 30 million dollars convertible note, 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 as of the immediately following those transactions.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Net of those deductions. What about going forward with the headcount reductions of the savings?
Brian McMichael, Chief Financial Officer, Coherus Biosciences: So net of the going forward, what you can expect is, as we mentioned, we have around two twenty five employees as of now and we expect to get that down to 155 employees. 50 of those employees, we expect approximately to transfer to a quarter, Intoss, and the rest will work out over the coming year.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thank you, Kripa. Did you have a follow on question?
Unidentified Speaker: Yes. I was just wondering about Lopterzi. I think you have the modified endocrine guidelines, you have preferred position for Lopterzi. Congratulations on that. I was just wondering if you have a sense of where the drug is being used now that you have both frontline and second line in guidelines?
Thanks.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thanks for that. Maybe Sameer has a few comments, some color he can provide on that. Sameer?
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: Yes, sure, Debbie. So just let me give you a little bit of historical context, right? The previous guidelines put us on the previous guidelines, there are multiple treatment options, including chemo alone, chemo plus other off label IOs and chemo plus Loprology. So as a result of that, we believe that fuels the extensive use of chemo only and ChemoPlus 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 ChemoPlus Doctor.
Z as the preferred treatment for first time metastatic patients and recurrent metastatic 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 BOPTURGY. And then 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 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.
Unidentified Speaker: Thank you so much.
Carmen, Conference Operator: Thank you. One moment for our next question please. It comes from Yigal Nochomovitz with Citigroup. Please proceed.
Yigal Nochomovitz, Analyst, Citigroup: Hi, Denny and team. Thank you. Just
Unidentified Speaker: on
Yigal Nochomovitz, Analyst, Citigroup: 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
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: transaction? Yes. So 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.
Yigal Nochomovitz, Analyst, Citigroup: Okay. So they don’t need to visit the facility. They just need to sign off on that data. Is that correct?
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: No, they do not need to visit the facility. They only need to review the data. Correct.
Yigal Nochomovitz, Analyst, Citigroup: Okay, got it. And on the CCRA, actually, I was curious, you have fairly specific timing, second quarter twenty twenty six for the Taurie combo and then the Phase 1b study in second line gastric. Could you just comment on how you’re able to arrive at such a specific timing, more than a year away for that study? Thanks.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: I think I’ll let Raj give you a little more color on that, Yigal. But I think the shorter answer is that we have making very good progress with respect to enrolling the patients and splitting them up. And 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. Rasha, any further color before you go?
Raj Dias, Chief Medical Officer, Coherus Biosciences: Yes. I’ll just hi, Igor. Thank you for the question. So just two or three additional questions. So first of all, you’ll recall we
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: already the study is
Raj Dias, Chief Medical Officer, Coherus Biosciences: in 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 head and neck study this year. And then for the expansion, as you quite rightly say, we anticipate both head and neck and gastric data 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 Cytochrome projections.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: The other comment that I would offer you, Yigal, is 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 execution along these lines is one of our strong points.
So happy to keep you informed.
Yigal Nochomovitz, Analyst, Citigroup: Okay, thanks. Last one quickly on Latorzi, did you take a price increase and if so, what was the percent?
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Yes, that’s great. Sameer, would you like to comment for you about the pricing?
Paul Reeder, Chief Commercial Officer, Coherus Biosciences: Yes, I’ll take that. Hi, Nicole. Yes, we did take a price increase. It was around 2.46%.
Yigal Nochomovitz, Analyst, Citigroup: Okay. Thank you.
Carmen, Conference Operator: One moment for our next question please. And it comes from the line of Colleen Kossy with Baird. Please proceed.
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: Hi, good afternoon. Thanks for taking our questions and congrats on the progress. For the head and
Teresa LaValle, Chief Development Officer, Coherus Biosciences: neck cancer data
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: 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?
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Hey, Colleen. Thanks. Brash, do you want to give a little color on Colleen?
Raj Dias, Chief Medical Officer, Coherus Biosciences: Yes, absolutely. Hi, Colleen. So yes, we’re expecting we will be reporting out data in the first half of this year at one of the major conferences is from part a little bit of data from 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 intra tumor biomarker data as well that we anticipate presenting as well.
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: Great. And then for the casdoso tory combo in second, fourth line non small cell lung cancer, can you just kind of help us set expectations for that data readout as well, please?
Raj Dias, Chief Medical Officer, Coherus Biosciences: 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 in the Stage one of the two stage, SAMA two stage design. But what I will say is that we anticipate focusing signal thus far.
Unidentified Speaker: Great. Thank you, Killeen. Thanks, Killeen. Thanks, Killeen. Thanks, Killeen.
Thanks, Killeen.
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: Thanks, Killeen.
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: Thanks, Killeen. Thanks, Killeen. Thanks, Killeen. Thanks, Killeen. Thanks, Killeen.
Carmen, Conference Operator: Thank you. Our next question is from Michael Nedelkovich with TD Cowen. Please proceed.
Paul Reeder, Chief Commercial Officer, Coherus Biosciences: Hi. Thank you for the question. I have one as it relates to the plan in non small cell lung cancer. So it sounds like you’re moving forward in squamous. I was just curious, what is the next step?
Is it a randomized Phase II? 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 casdoso development in lung cancer? Thank you.
Raj Dias, Chief Medical Officer, Coherus Biosciences: Hi, Michael. So I’ll take the first part of that question. So our anticipation is that we once we have completed a robust dataset in the combination of toripalumab with KEZDOZO 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 a Phase twothree.
So the Phase three study will be a standard Phase three and will be 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 docetaxel. And while I won’t comment on what exactly we what bar we’re expecting to see, you know what the docetaxel overall response rates are. So the subsequent Phase III study will be against standard care docetaxel.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Regarding funding of the Phase III, that’s not within the window of the two year guidance that we’ve gone up so far. But I think there’s a number of options to proceed with that given the data. And I would also indicate that about three to four years during that such time, we think that we have, atorapelumab pretty much at full force in the nasopharyngeal cancer space with the one hundred and fifty million to two hundred million.
Paul Reeder, Chief Commercial Officer, Coherus Biosciences: Great. Thank you.
Raj Dias, Chief Medical Officer, Coherus Biosciences: Thank you.
Teresa LaValle, Chief Development Officer, Coherus Biosciences: Thanks,
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Michael.
Carmen, Conference Operator: One moment for our next question that comes from the line of Brian Cheung with JPMorgan. Please proceed.
Jody Sievers, Head of Investor Relations, Coherus Biosciences1: Hey guys, thanks for taking our questions this afternoon. Maybe first one is for Paul. On Lactorsy, 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 LORTORCE?
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Yes. Well, thank you for question on that, Brian. I think Sameer can probably provide you a little color on that.
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: Yes. So let me start with a question about the stickiness of Loptrigy, right? So what we’ve seen is the physicians who have used Loptrigy since launch have been very satisfied with Loptrigy and they’ve been advocating on behalf of LOCK40. So we expect that they will continue to have repeat use of LOCK40. 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 use Loporzi, 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 Loporzi and the data from Loporzi. 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 OPORIY, 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 chemo only business.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thanks, Brian. Did you have a follow-up?
Jody Sievers, Head of Investor Relations, Coherus Biosciences1: Yes. And then maybe just one quick one, related to the Phase one CCRA tory 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 as further supportive for your ongoing work in head and neck?
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Great question. Maybe Doctor. Livalle can handle that one for you. Theresa?
Teresa LaValle, Chief Development Officer, Coherus Biosciences: Yes, Brian. Thanks for that question. There are a couple of things we’re looking for. First, we’ve shown robust depletion of CCR8 positive Tregs in the periphery that sustained over the dosing cycle. We want to be able to see that in the tumor.
And secondly, what’s been demonstrated in preclinical models is that removal of the immune suppressive cell, the CCRA positive Treg, there’s a broad infiltration of CD8 T cells. So that ratio of immune suppressant 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 in the CD8 cells to tip the balance to immune
Unidentified Speaker: activate it.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Got it.
Jody Sievers, Head of Investor Relations, Coherus Biosciences1: Thank you so much.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Thank you, Tristan. Thanks, Brian.
Carmen, Conference Operator: Thank you. Our next question is from Douglas Tsao with H. C. Wainwright. Please proceed.
Douglas, your line is open.
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: Sorry about that. I was on mute. My apologies. Thanks for taking
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: the questions and congrats on
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: the progress. I guess just one follow-up for me. I’m just curious, in terms for Lactorsy in the MTC market, how much continued use is there of off label IO agents given with the NCCN guidelines out there now? And how long do you think it will take for you to sort of capture all that volume? Thank you.
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: Yes, thanks. So your question is
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: how much off label other CD1s without label and how long will it take us before we really embed Bacterozine as time care? Sameer, yes?
Jody Sievers, Head of Investor Relations, Coherus Biosciences1: And maybe what are some of
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: the things that you need to do to have that happen?
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: Great. Got it. So our business opportunity is divided between the academic and hospital setting and the community setting. In the academic setting, there’s a pretty good awareness, especially the head and neck cancer specialist, there’s a pretty good awareness of the guidelines and the data for laboratory. In the community setting, all of these physicians are seeing lots of different cancer types and MPC 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, it’s going to be an ongoing process.
We did some market research recently and there’s about a 40% awareness of the NCCN 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 Loft four gs. Last thing I’ll say, just to reiterate what I said earlier, when we do have a conversation with a physician who is thinking about MPC, it resonates really well and they get excited about our PFSOS data and the guidelines.
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: And I guess just as a follow-up, I mean, do you anticipate it being easier channel sort of easier task in the academic centers? Is it the community where you have more work to do?
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: Yes. I think we have
Sameer Goregelkar, Senior Vice President of Immuno Oncology Marketing, Coherus Biosciences: to be we can just focus on the academic centers. We obviously want to get all the academic centers on board. We want to drive usage in hospital settings. But we want to establish ourselves as a standard of care. There’s a lot of MPC use treatment of MPC 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.
Jody Sievers, Head of Investor Relations, Coherus Biosciences0: Okay, great.
Raj Dias, Chief Medical Officer, Coherus Biosciences: Thank you. Thanks Doug.
Carmen, Conference Operator: And thank you. And this concludes our Q and A session. I will turn it back to Lanny Lanphier for his final comments.
Denny Lamphere, Chief Executive Officer, Coherus Biosciences: 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, IntoroFALMAT and 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. And thank you very much.
Carmen, Conference Operator: And thank you all for participating in today’s conference. You may now disconnect.
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