Coherus BioSciences Inc
NASDAQ:CHRS
Earnings Call Analysis
Q4-2023 Analysis
Coherus BioSciences Inc
In the final stretch of the year, the company demonstrated robust financial performance. Fourth quarter (Q4) sales reached $2.2 million from 3,800 cartons, contributing to the full year net sales total of $3.6 million which indicates the business's capability to generate revenues from its products. Additionally, the company shattered expectations with its net revenue in Q4 leaping to $52.4 million, a significant 31% increase from the previous quarter, and concluded the year with net revenue of $125.4 million, surpassing the guided benchmark of $100 million.
Looking forward, the company prepares for slower growth in the HUMIRA biosimilars segment through 2024. Noteworthy is the anticipation of the Inflation Reduction Act of 2025, suggesting investors should stay tuned to how this legislation might affect growth trajectories starting that year.
LOQTORZI, the company's oncology asset, plus chemo remains the sole FDA-approved treatment for recurrent estatic Nasopharyngeal Carcinoma (NPC), marking a critical advantage in the healthcare market. The product has already seen $600,000 in Q4 sales due to initial wholesaler stocking and forecasts a significant potential market valued up to $200 million at peak.
The support for LOQTORZI extends to the nation's top opinion leaders in NPC, with over 90% endorsing LOQTORZI plus chemo as the new standard of care, reinforcing its market position. The treatment garnered a preferred listing in the ASCO and NCCN NPC guides, and payer coverage includes roughly 95% of targeted lives. Adoption is further facilitated by innovative tools that help identify NPC patients, optimizing market penetration.
Recent months have been pivotal for LOQTORZI within the immuno-oncology portfolio. Following FDA approval, published data reveals a hazard ratio for survival of 0.63, translating to a 37% reduction in mortality risk for patients with advanced NPC, thereby reinforcing LOQTORZI’s efficacy.
The company’s focus extends beyond NPC, with strategic endeavors to partner and develop toripalimab therapies for additional tumor types. An exemplar is the recent partnership with INOVIO, exploring toripalimab in conjunction with an HPV-targeted DNA-based vaccine, for a study in advanced head and neck squamous choriocarcinoma. It's an indication of the company's agile approach to leveraging partnerships for expanding its clinical reach.
The clinical pipeline holds promise, especially with casdozo, the inaugural and only clinical-stage anti-IL-27 molecule. By integrating novel agents with the foundation laid by toripalimab, the aim is to recalibrate the tumor microenvironment in favor of an enhanced anti-tumor response, potentially offering additive benefits to patients.
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Good day, and thank you for standing by. Welcome to the Q4 2023 Coherus BioSciences, Inc. Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jami Taylor, Head of Investor Relations for Coherus.
Thank you, operator. Good afternoon, and welcome to Coherus Biosciences Fourth Quarter and Full Year 2023 Earnings Conference Call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Bryan McMichael, Interim Chief Financial Officer; Paul Reider, Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa Lavelle, Chief Development Officer.
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: our ability to advance our pipeline, projections of future growth, revenue, expenses, headcount and debt levels and the timing of any return to profitability or cash flow positivity. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance or achievements to differ from those implied by the forward-looking statements.
These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process, that are discussed in our press release that we issued today as well as the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements.
With that, I'll turn the call over to Dennis.
Thanks, Jami, and thank you all for joining us on the call today. I'm pleased to report to you today's strong fourth quarter results rounding out an important year of transition for Coherus as we sharpened our focus on innovative oncology, resisting the company for new levels of efficiency and growth in 2024 and beyond.
Our strategy and our mission are clear, to extend the lives of cancer patients. Today, we are delivering on this strategy in every front, positioning Coherus for long-term sustainable growth as an oncology company. We believe this strategy creates long-term shareholder value as we develop and deliver next-generation oncology treatment for patients. We continue on the path we set forward last year, which is to first drive sales growth and revenues across the oncology portfolio. With new product launches of UDENYCA and LOQTORZI.
Secondly, simultaneously reduce our spend and interest costs. Third, realign our balance sheet by reducing our debt and advance our high potential pipeline focused on the tumor microenvironment and those complementary with our PD-1. We experienced double-digit sales growth in 2023 and I'll let Paul Reider, our Chief Commercial Officer, to discuss continued progress on levering and share growth in just a moment.
Let me start with the spending and headcount reductions in 2024. Now last year, we began a multifaceted process of driving new efficiencies through headcount reductions, product divestitures and business process integration for greater efficiencies. Today, as part of this plan to position us for sustainable growth, we are announcing a 30% headcount reduction for 2024 and cost reductions as part of our transformation.
We are projecting an SG&A with R&D spend for 2024 of $250 million to $265 million, which has reduced from $301 million in 2023, which itself was reduced from about $400 million in 2022. This reduction was the result of a rigorous evaluation of every role within the company, with the objective to reduce or eliminate FTE spend wherever possible. These actions demonstrate that we remain highly committed to returning to profitability as soon as possible and cash flow positivity in 2024 remains our goal.
Now as previously stated, monetization of ex U.S. rights is one of the cash management levers we seek to use to preserve our capital. Accordingly, we have agreed with Junshi to defer and reduce $25 million approval milestone payment scheduled for this quarter, Q1 2024. This payment is now bifurcated into 2 parts. $12.5 million to be paid next quarter to 2024, an additional payment of $12.5 million to be paid in Q1 2025 and such second tranche to be potentially reduced by proceeds from the monetization of Canadian to our [ Palm network ]. This reflects our strong partnership and high level of option with Junshi.
With respect to realignment of our balance sheet and reduction of debt, we are pleased with the financial outcome for the divestiture of our ophthalmology franchise. Our efforts to strengthen our balance sheet and overall capital structure are progressing well, and we recently announced the renegotiated agreement with Pharmakon Advisors, pay down $175 million in term loan debt decreasing our term loan interest payment burden by roughly 70% moving into the remainder of 2024.
The ophthalmology divestiture also allows us to streamline operations. Today, Coherus is a leaner, more efficient and more nimble organization, capable to compete in the marketplace with even greater focus, agility and intensity, tightly focused on being a sustainable and growing oncology company. With LOQTORZI, we are gaining predictable and growing high-margin revenues from our innovative product and are able to realize the synergies of having 2 adjacent oncology products. We congratulate our R&D and regulatory teams for their success in securing 3 product approvals in 2023 from the FDA. This is a major accomplishment for any company, especially one of our size. The FDA approvals of the UDENYCA auto-injector, UDENYCA on-body injector and [indiscernible's] and nasopharyngeal cancer have positioned us for further commercial success in 2024, capitalizing on synergies.
Each of these products align to our vision of oncology leadership in each paves the way for the impressive slate of tumor microenvironment focused immuno-oncology assets in our development pipeline. As Dr. Dias will describe first-in-class and potential best-in-class drug candidates have the potential to deliver on our vision of extending patient survival and driving long-term shareholder value creation.
Now with that, I'll turn it over to my Chief Commercial Officer, which is Paul Reider. Paul?
Thanks, Denny. Good afternoon, everyone. We ended 2023 with strong momentum to the business with the divestiture of ophthalmology franchise. We'll use this momentum in 2024, a hyper focus on our oncology business, drive top line growth of our core oncology assets, UDENYCA and LOQTORZI.
For the fourth quarter, combined net product revenue was $91.4 million, an increase of 23% over Q3. Full year 2023 net product revenue was $256.6 million, a 22% increase over 2022. I'll now speak to each brand, and we'll begin with oncology, starting with UDENYCA. I'm excited to announce that in Q4, UDENYCA eclipsed 1 million units sold since its launch, a significant and important milestone and demonstration of our customers' belief in UDENYCA and Coherus' continued commitment to cancer patients. Now that both the UDENYCA auto-injector and on-body presentations are launched, our strategy moving forward is to deliver profitable revenue and market share growth fueled by 3 drivers.
First, UDENYCA is the only pegfilgrastim brand with 3 device options to meet the unique needs of providers and patients. This strengthens our competitive position and allows us to compete on factors other than price. Second, the launch of UDENYCA on-body, a novel and proprietary state-of-the-art delivery system with pegfilgrastim enabling us to compete now within the entire pegfilgrasti market. And third, we come into 2024 with payer coverage of nearly 2x that of 2023. And opening up access to significantly more patient lives.
Our disciplined execution of this strategy is delivering a third consecutive quarter of UDENYCA revenue and demand growth.
Q4, net sales were $36.2 million, an increase of 10% quarter-over-quarter. Total unit demand grew 7% quarter-over-quarter, driven by increased payer coverage continued growth of the prefilled syringe presentation and accelerated adoption of auto-injector. Customer enthusiasm for the UDENYCA auto-injector presentation led to a 129% demand growth quarter-over-quarter. And since commercial launch in May of 2023, 727 accounts have ordered the autoinjector presentation.
UDENYCA on-body was launched last month in February and high customer demand for a unique and differentiated on-body device, coupled with confirmed payer coverage, is leading to encouraging demand uptake in these first few weeks of launch. With 138 accounts already ordering on-body. Based on data from IQVIA, rolling 4-week UDENYCA market share, as of March 1 was 26%, representing an increase of 15 market share points versus the same time period in 2023. UDENYCA is now a franchise and the only pegfilgrastim brand with 3 presentation offerings now becoming the total solution for oncology providers.
With respect to noncore assets, I'll start with the summary. In Q4, we sold 3,800 cartons, generating net sales of $2.2 million. Full year 2023 net sales were $3.6 million. We continue to expect slower growth for HUMIRA biosimilars through 2024 until the implementation of the inflation Reduction Act 2025. Regarding similarly, net revenue in Q4 grew to $52.4 million, an increase of 31% quarter-over-quarter. Full year 2023 net revenue was $125.4 million, exceeding our guidance of at least $100 million. Similarly, market share within the ranibizumab class was 34% for an increase of 6 market share points quarter-over-quarter.
Let me conclude now with LOQTORZI, our other core oncology asset. LOQTORZI plus chemo is the first and only FDA-approved treatment for recurrent estatic NPC in all lines of therapy. We launched January 2, and it's going well, with demand uptake tracking to expectations. For Q4, we recorded $600,000 in sales based on initial wholesaler stocking to support the commercial launch. NPC is a rare cancer, and we estimate that the U.S. NPC market is valued up to $200 million at peak, consisting of approximately 80,000 recurrent or metastatic NPC patients were diagnosed each year and are split evenly between those in first-line versus second line plus.
With LOQTORZI broad indication in all lines of therapy, we are executing a plan to establish LOTORZI plus chemo as a new standard of care and our ambition will make LOTORZI available with many NPC patients as quickly as possible. Our conviction and achieving this ambition is bolstered by the following. First, we have strong advocacy from the nation's leading opinion leaders in NPC. During the multidisciplinary head and neck cancer symposium, well, just 2 weeks ago, we held over 50 one-on-one in-person meeting with the nation's top opinion leaders and over 90% of them preferred universally that LOQTORZI plus chemo will become the new standard of care in NPC based on its FDA-approved indication and the strength of the Phase III data that includes significant improvements on progression-free and overall survival.
Second, LOQTORZI has achieved preferred listing on both the ASCO and NCCN NPC guides. Rosh will speak to this further. LOQTORZI is the only PD-1 with a Category 1 designation with NCCN for first-line use, a clear differentiator for LOQTORZI and a core message in the LOQTORZI promotional message campaign.
Third, we've confirmed payer coverage now to label with payers representing approximately 95% of targeted lives. This includes Medicare fee-for-service. Fourth, the innovative tools we deploy to identify NPC patients are bearing fruit. We've invested in and deployed real-time claims associated with NPC ICD-10 codes as well as electronic medical record data sources to help identify appropriate NPC patients be identified, of course. These tools alert our field teams in real time, but an oncologist has an NPC patient, which then triggers 2 actions.
First, LOQTORZI sales call with that doctor. And second, paper targeted branded digital advertising to that oncologist. In terms of early impact, over 60% of accounts that have ordered LOQTORZI thus far were sourced from the use of these tools. Last and most of them, oncologists are prescribing LOQTORZI. Since lauch, we've had 59 accounts order LOQTORZI, priced both clinics and hospitals. With respect of the 33 NCCN designated cancer centers, 55% have already added LOQTORZI to formulary with the remaining centers in P&T review, and I'm confident we'll have successful outcomes with these centers as well.
In summary, we're excited to become a trusted partner with in the head and neck community and to bring new hope for greater survival for NPC patients nationwide.
With that, I'll now hand it over to Rosh.
Thanks very much, Paul, and good afternoon, everyone. Past few months have been an exciting time for LOQTORZI, which remains foundational element of our immuno-oncology portfolio. Following an FDA approval on October 21 of last year, final overall survival data from the pivotal registration study, 22 was published in January to November showing a hazard ratio for survival of [ 0.63 ] favoring the LOQTORZI the arm, which represents a 37% risk reduction in mortality in patients living with advanced NPC. This overall survival advantage is not only statistically significant but also very clinically meaningful as NPC patients have not, up until now, had any approved treatment options for their disease.
Within 6 weeks of approval, [ Optus ] was also included in the NCCN guidelines for NPC by the NCCN head and neck panel with a very strong positioning. First-line disease, LOQTORZI is listed as a preferred therapy and the only checkpoint inhibitor with Category 1 designation, which does reflect the highest level of evidence for the uniformity of the panel members decision.
The second line and beyond LOQTORZI is the only gent listed as a preferred therapy, and both designations are very reflective of both designations are very reflective of both the strength of the data and the clear unmet medical need. Outside NPC, several additional positive Phase III data sets have been published over the past few months or in high-tier journals, including the NEOTORCH study in JAMA, showing a positive and profound event-free survival benefit favoring toripalimab in perioperative locally advanced non-small cell lung cancer. Torch light in Nature Medicine with a positive progression-free survival benefit in triple-negative breast cancer and NEOTORCH in the analysts of oncology showing a PFS benefit in nasopharyngeal carcinoma.
In addition, positive randomized Phase II data in locally advanced gastroesophageal junction carcinoma has also been published recently in Nature Medicine. We've been very consistent in our communication that our strategic approach in tumors outside NPC will be in developing toripalimab in combinations of partnerships and therefore, these positive data sets across additional tumor types sets us up well for partnerships, not only in NPC but also beyond the toripalimab form in the backbone for investigation in combination with other novel investigational agents.
A recent example of this was our INOVIO partnership, where we announced that we will be supplying toripalimab in combination with INOVIO DNA-based vaccine directed against HPV-positive tumors for investigation in a registration-enabling study in locally advanced head and neck squamous choriocarcinoma, a tumor type that is complementary to our current indication in NPC.
Regarding our clinical stage pipeline, we remain excited about the potential to combine our novel agents on top of the toripalimab backbone by targeting both the T-cell with toripalimab and also the tumor microenvironment with our novel agents. The aim will be to make the tumor microenvironment more favorable to antitumor effect and therefore, realize potential additive benefit.
Regarding casdozo [indiscernible], our first-in-class and only clinical stage anti-IL-27 molecule, we presented data at ESMO IO in December in advanced non-small cell lung cancer whereas to have demonstrated monotherapy responses in PD-L1 refractory non-small cell lung cancer with no safety concerns. These encouraging data position us well for further investigation of casdozo in this tumor type in combination with tori and we are currently enrolling patients in a new arm in casdozo Phase Ib study evaluating Catoca in combination with toripalimab in patients with advanced non-small cell lung cancer. Study is currently open and we have open, and we have patients active on study, and we anticipate presenting data from this study either later this year or early next year. On Hepatocellular Carcinoma, we presented casdozo data in first-line HCC at ASCO GI in January with casdozo in combination with [ atezo ] and BEV demonstrating an overall response rate of 38% [indiscernible] and 43% by [ MR ASSIST ] complete responses in 3 subjects.
Recall earlier data that we presented from this study last year showed an overall response rate of 27%, with only partial responses. So this increase in response rate together with deepening of the responses is very encouraging. Moving forward, we will be investigating casdozo in combination with toripalimab and bevacizumab in first-line HCC, which we anticipate will start later this year. We're particularly encouraged that the clinical activity observed with our IL-27 antagonist casdozo has, in addition to clinical response demonstrates immune activation in liver and lung patients.
The biomarker work from these 2 clinical studies that have revealed an association of high levels of IL-27 expression in tumors and catdoza response. We will continue to evaluate if IL-27 expression is informative for indication selection or if it can improve patient outcomes as a predictive biomarker. Other tumor types besides lung cancer and HCC that have high levels of IL-27 expression, to head and neck cancer, gastric cancer and triple negative breast cancer. LOQTORZI demonstrated activity in several of these tumor types that supports the potential for additional synergies of the casdozo tori combination treatment in some of these additional cancers.
Finally, CHS-114, our CCR antibody is nearing completion of the dose escalation stage of our Phase I study without any safety concerns. Nonclinical data presented at safety last year, highlighted the potential for targeting CCR8 to deplete Tregs in the tumor microenvironment to enhance antitumor response in head and neck squamous cell. Once dose escalation is complete, we plan to expand the study to explore CHS-114 in combination with toripalimab in patients with head and neck cancer, where the biology of the target shows strong disease linkage.
I'll now turn it over to Theresa.
Thank you, Rosh, and good afternoon, everyone. I want to once again thank the FDA for taking the approval action in a timely manner and much faster than the BsUFA 6-month time period for the UDENYCA on-body supplement after our resubmission in October. With both the UDENYCA on-body approval, and approval of LOQTORZI for all lines of therapy and all patient subsets of nasopharyngeal carcinoma, the coherence oncology franchise is well positioned.
LOQTORZI is a next-generation PD-1 inhibitor with potent activation of T-cells, including demonstrating significant activity in tumors that are less inflamed. Our LOQTORZI the mechanism of action paper recently published in cancer immunology immunotherapy describes its potent activity on T-cells that is attributed to both by binding affinity for PD-1 and its finding at a unique epitope, the FT loop of PD-1.
LOQTORZI is the foundation of our I-O franchise, and we are excited to explore clinical opportunities to extend patients survival with all combinations, particularly with agents that target mechanisms of PD-1 resistance due to immune suppression in the tumor microenvironment. Immunosuppressive M2 macrophages have been well characterized to dampen the immune system. Our CHS-1000 program and the anti-ILT4 antibody is on track for IND submission in the second quarter of this year. We will be presenting clinical data from our CHS-1000 program at AACR in April.
The poster presentation presents the nonclinical characterization of CHS-1000 showing it as an IL-T4 selective and potent antibody that promotes an inflammatory immune response. Tumor types with high expression of IL-T4 includes latent, head and neck, liver, rest and ovarian cancer. In addition to advancing new LOQTORZI indications with combination treatments using the Coherus pipeline targeting TME -- the TME. We have a number of exciting novel external combinations and discussions. Another important partnering initiative is exploring novel combinations with casdozo and CHS-114. Given their safety profiles, strong line of sight to tumor indications and immune modulation in cancer patients, there are several rational combinations such as bispecific antibodies, including T-cell engagers, ADCs, targeted therapies and even car-T therapies. I'll now turn the call to Bryan.
Thank you, Theresa, and good afternoon, everyone. I'll briefly review the results for the quarter and the full year. As Paul cover revenues, I will start with costs and expenses. Cost of goods sold increased significantly for the year to $159 million compared to $70.1 million in the prior year, driven primarily by our noncore products. Specifically in Q4 2023, we recorded a $40 million charge for the write-down of slow-moving summary inventory and related firm purchase commitments. In addition, similarly COGS included a low to mid-50% royalty on gross profits. Gross margin for the fourth quarter was 8%, excluding the $47 million write-down, gross margin for the quarter would have been 59%, including the royalty on similarly gross profits mentioned earlier and the mid-single digit royalty we pay to UDENYCA -- we pay on UDENYCA net sales.
We ended the year with R&D expense totaling $109.4 million, down $89.9 million from the prior year. R&D expense for Q4 2023 was $26.4 million, a decrease of $2.7 million from the same period in the prior year. The declines reflected expenditures in 2022 that did not reoccur in 2023. Namely, the $35 million TIGIT option fee in Q1 2022 and other descoped co-development costs with Junshi. The cost of preparing for launches of new products that happened during 2023 and savings with reduced headcount.
SG&A expense for the year was $192 million, down from $198.5 million in the prior year. For the quarter, SG&A expense was $49.5 million, down $4.1 million and 8% compared to a year ago, decreases primarily reflected savings from lower headcount, partially offset by other costs. For the fourth quarter of 2023, we reported a net loss of $79.7 million or $0.71 per share compared to a net loss of $58.9 million or $0.76 per share for the same period in 2022. Cash and cash equivalents and investments in marketable securities were $117.7 million as of December 31, 2023, compared to $192 million at December 31, 2022.
Our 2023 results included $4.5 million of interest expense. We expect to reduce our cash flow borrowing costs by more than $24 million on an annualized basis following the partial paydown using proceeds from the similarly divestiture. In addition, we expect to save at least $25 million on an annualized basis in OpEx due to headcount reductions associated with the divestiture and the reduction in force.
After factoring in these savings in addition to those expected from the termination of the TIGIT program that we announced in January, Coherus is introducing a 2024 guidance range of combined R&D and SG&A expense of $250 million to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of strategic acquisitions, collaborations and investments, the exercise of rights or options related to collaboration programs and any other transactions or circumstances not yet identified or quantified.
With that, I'll turn the call back over to Denny.
Thank you, Bryan. Operator, we're ready to open the line up for questions.
[Operator Instructions]. Our first question comes from Robyn Karnauskas with Truist Securities.
This is Nishant. I am on for Robyn. So I have one on UDENYCA and one on LOQTORZI. So with UDENYCA, you continue to increase market share, it's up 7% points quarter-over-quarter, but however, the sales are up by 10%. Can you provide more color, how much was the effect of net selling price reduction this quarter? And for LOQTORZI, you mentioned the launch is going well. Can you provide more color as in whether the drug has been used more in frontline or second-line setting?
Thank you very much. Paul will be happy to address your question with respect to UDENYCA. And then secondarily, the question of launch of first-line versus second-line LOQTORZI. Paul?
Yes. Nishant, thanks for your question. Yes, so the effect of the net selling price quarter-over-quarter was in the mid-single-digit range. And as I mentioned in my remarks, our focus now that we've launched both and have all 3 presentations is that we're now going to drive the franchise to profitable market share and revenue growth. And that's going to be our plan in 2024 and beyond. We're going to do that because we have now all 3 presentations can access the entire market. We've locked in great payer coverage and we've been able to have a competitive ASP. So we're looking forward to a successful 2024 with UDENYCA franchise.
Regarding LOQTORZI in your question about are we getting first line or second line, we're just a couple of months into it. I'll be better able and -- on our first quarter call to give you more specifics. But what our intelligence tells us now is we're getting patients across all lines of therapy. And that's not unexpected given that we've got the indication for all lines of treatment, but many of the patients that are just gotten chemo in second line, they're going to get LOQTORZI immediately now. So we're getting it in both lines, which is great, and the launch is going very well. So...
I think an ancillary response to your question, Nishant, exist like to comment on the selection of LOQTORZI as a PD-1 for patients diagnosed with NPC.
Yes, happy to. So I can tell you as a physician, doctors tend to be very evidence-based and data-driven. What I will say is that LOQTORZI has 3 things that other checkpoint inhibitors do not have. First of all, we have data from a randomized controlled study and not only do we have data, we have overall survival data, which is actually the gold standard that oncology to look for. And I mentioned the 37% risk reduction in terms of survival advantage with the addition of LOQTORZI.
Secondly, of course, we have a label and other checkpoint inhibitors do not have a label and not only -- actually not only do other checkpoint inhibitors do not have a label, there's no other indicated therapeutic agents for NPC. And thirdly, I'll say to Denny's point, we also have preferred positioning in terms of NCCN guidelines. We are the only Category 1 listed agent for first-line in terms of immunotherapy, and I think that really does reflect the strength of the data and the confident the data in this area of unmet need.
Our next question comes from Yigal Nochomovitz with Citigroup.
On the liver cancer study, I'm just curious, I think the key comp there is IMbrave150. Nominally, you are above those numbers. Of course, the numbers are small. I'm just curious if you could comment as to how much better you think you'd need to be than in the IMbrave150 benchmark to be on a go-forward decision with your triple combo.
Thank you, Yigal. Rosh Dias can address that.
Yes. So you're absolutely right. The IMbrave data with rituximab is actually the only -- rituximab is a license indication right now. So we've shown a response rate, as I said, of 38%, 43% with [ MR ASSIST ]. I think we'll be looking at this is the kind of range we're actually looking for, for further development, right? So I think we've -- data that we presented at ASCO GI in January is exactly what we were looking for, and we will be following up with a further study that's going to start later this year. We're looking at that triple combination.
Yes. And if I can add to that, I think in a 30-patient study, the numbers are higher, but it's not an apples-to-apples comparison. So we were excited, as Rosh mentioned, in both the deepening of response and the improvement in revision study continues to evaluate data but important in a 30-patient Phase II study is also to look at how those responses track with IL-27 biology. So when -- while the numbers, again, are small, very provocative that we see an association of IL-27 expression with response.
Additionally, this is a program that has shown preclinically that there is strong activity in HCC and multiple models, the biology of IL-27 coming from the tissue resident macrophages, so liver macrophages cooper cells is really one known to dampen the immune response. And that activity that was specific in preclinical models to liver cancer and lung cancer translate in humans. So I think that with the biomarker data in the responding patients showing modulation of the IL-27 pathway in association with response and the high levels of IL-27 expression has incredibly excited to do [ Batory as Dozo Fab ] combination.
And maybe one last thing I'll add, safety is always important. We showed a very -- it's a very clean safety profile as well.
Very important.
Thank you, Yigal.
Okay. Can I ask another one. I was curious on one on CH-114. Theresa, you mentioned the dose escalation and then you're going to do the comboatory. I think in your slide deck in early January, you indicated there'd be some data in the first half of the year for the Phase I. I wasn't sure if that was still the expectation? Or just help understand that, please?
Yes. We plan to present the dose escalation in the first half of the year at a major medical conference.
Our next question comes from Colleen Kusy with Baird.
I think revenue guidance is something you've given in the past, it looks like you're not providing revenue guidance for 2024. So can you just talk a little bit about that decision and what you think some of the levers are for revenue growth this year?
Thanks, Colleen. I'll take that one and let Paul backfill. I think the primary issue is that we have freshly launched the UDENYCA on-body. We're very excited about the enthusiasm that's been received in the market. But the ultimate trajectory of that across 2024, it is not yet known. It's only been out of the market for about a month.
As Paul pointed out though, we have seen a 129% increase with respect to the auto-injector uptake. And the trailing 4-week data for UDENYCA itself is north of 25%, up from Q4. So that's a very, very compelling. I think that would give us greater certainty with respect to the trajectory and the steepness of the trajectory. Once we get a little further into Q1 and get that below us, all the indicators are positive. But I think certainly on the next call, we'll be able to give you some additional information on that.
With respect to LOQTORZI, as Paul indicated, we're very pleased with the launch. Our digital strategy over the last 2 years of basically developing a relationship with the patient is very, very good. We are very pleased with the uptake, very pleased that P&T committees and how well we're doing there. But I think that's going to take a little bit of time. It takes a month or 2 to get on a familiar for a P&T committee in a major hospital in some place, the East Coast or something. So we're happy to do that, but we just would like probably another quarter under our belts before we go ahead and we do projections with respect to revenue.
But on the topic of revenue though, I would make one will make one key point for you is the quality of the revenues is just as important, if not more important, as the size of the revenues. And we expect that the margins and the quality of the revenues, for example, with LOQTORZI and UDENYCA will lead to greater profitability as we go into the back side of the year. And as Paul said, that's really where we're focused. We want to drive the top line, but we also really -- the quality of the revenues, especially with the product like LOQTORZI. It is going to be far better, more stable and more sustainable than your typical biosimilar.
That's helpful. And maybe a follow-up on your comments and just a quick clarification. On cash flow positivity. I think you said the goal is cash flow positive in 2024. Can you just clarify, is that guidance for cash flow positively in 2024 or not specifically, maybe dependent on revenue or other factors?
Without being able to predict revenues, I can't really predict cash flow positivity. But I would just make the key point that I think that we've made substantial progress with respect to reducing our SG&A and R&D line, even in the face of several launches over the past 12 months, we have reduced our head count over the past 2 years from 22 to '23 to '24 from 260 to 290 and now targeting 215 FTEs by the end of this year. I mentioned our overall SG&A reductions. So I think that we are running a very, very efficient organization as we focus on oncology.
At the same time, we're driving the revenues higher, as you can see. And then lastly, we're making very good progress reducing our interest cost. Bryan recapitulated that for us, but a 70% reduction in our fixed term loan interest costs where we're paying SOFR plus 8. I think that's really very significant. So we're going to continue in this direction. And just where those 2 lines cross, we can't quite predict but that's our north star and our guiding light and where we're going.
Our next question comes from Michael Nedelcovych, with TD Cowen.
Thanks for the question. You have a wealth of opportunities in terms of various combinations in various tumor types and indications where those combinations might be tested. Can you give us a sense of pipeline priorities and when those priorities might translate into discrete go/no-go trials or even pivotal trials?
Thanks for the question, Michael. I'll get Dr. Lavallee address that. Theresa?
Yes. Michael, thanks. We -- as we've talked about with casts, the lung cancer study is open. I mean that's a home run kind of strategy, a high bar, but given the monotherapy activity of casdozo, which was not expected to see in cancer patients. LOQTORZI combination should show by data by the end of this year or early next year. We're all looking at earlier lines of treatment based off of the LOQTORZI positive data trials such as NEOTORCH to further explore lung cancer, the HCC study, we plan to open later this year, so data next year.
As we mentioned, the 114, the CCR8 antibody will be presenting in next quarter. So I think the news flow from that plus a number of partnerships. We've already announced the INOVIO one, you'll see other ones, and that will be generating data next year also being presented.
And the part that isn't appreciated about toripalimab is Junshi continues to develop it and is now all of their studies are multiregional clinical trials, which would make it acceptable to the FDA. And so they have a Phase III ongoing with their pipeline. So we'll be watching. While we're not part of that study or funding that study. Clearly, as it gets registered, we have the market share. So we'll be watching for that. And that study opened last year. So typical small cell lung cancer Phase III metric, so later in the next couple of years.
Our next question comes from Chris Schott with JPMorgan.
This is Ethan Brown on for Chris Schott. Just to start off, can you maybe offer some color on how you're thinking about OpEx looking past 2024, given, on one hand, you have the pipeline that you're trying to progress and then balancing that against the company's past profitability? And then I have one more question after that.
I'll let Bryan make McMichael take a shot at that. Bryan?
Yes. So we're not providing guidance beyond '24 at this time. As we get into -- as we sort out some of the things we're working on with our capital structure, we'll have a better idea of how we'll move forward from there. And that will inform how we move forward in 2026.
Yes. I would say after we achieve profitability and cash flow positivity, we intend to stay profitable, if that's your question. I would offer you one other -- I would offer you another point, which is LOQTORZI. We expect LOQTORZI to reach peak sales in 2.5 to 3 years. And we further expect a continued increase in market share for UDENYCA over the short to medium term. So both of those things will continue to drive top line for us. And further, we'll continue to show very high degree of discipline with respect to controlling our expenses and SG&A, as you've seen already.
That's very helpful. And then just pivoting over to UDENYCA. Is there any color you can offer on how much sales at this point is coming from the auto injector versus the traditional presentation? And maybe more broadly, just your expectations for pricing looking to 2024? And maybe more specifically, if you think Coherus is now more insulated versus other players given you have the whole suite of products approved in the market?
Yes. That's a very, very, very good question. Very observed with nuance. I'll let Paul address that particular issue, the 3 presentations and our ability to have a sustainable franchise in the market and support pricing. Paul?
Yes. Chris, thanks for your question. So our whole strategy with UDENYCA with the 3 presentations is to give the customers choice so that they can choose the presentation that meets the unique needs of the patient and the doctor. And that's no other brand can do that. We saw pretty impressive growth with auto-injector in the fourth quarter. Driven largely in the clinic market. And that's because now we've got nurses that we're using it a great experience with it, liked it, and it's starting to now get its foothold into the into the workflow in the offices.
As it relates to the percent of the AI business to the total UDENYCA, it was still under 10%. So the workforce continue to be the prefilled syringe presentation. But as we see in 2024, that's all going to take a new shape now that we have our on-body device launched as well as the auto-injector in the prefilled syringe. But as I mentioned in my remarks, Chris, moving forward in year 6 of this brand's life cycle, we're getting that second wave of growth our focus is really around driving profitable revenue and market share growth. And we are confident we're going to do that in 2024.
Ethan, the other point that I would make is we've played the long-term game here with UDENYCA as Paul said we're 6 years in. We invested significantly both in the auto-injector, some $25 million in years past. It took us at least 3 or 4 years to bring forward the on body. That was probably a $35 million investment. We underwent a number of years where we had very strong discipline around pricing and ASP management, consider ourselves good stewards of ASP. In the interim, others have exited the market with aggressive pricing, we're still there. The new market entrants really haven't had an impact on the business. And I think that the significant market share increase like the 4-rig trailing 25% and our look forward here for 2024 shows that our long-term strategy is paying off. We're the only folks that have the 3 presentations we're positioned for market stability and sustainability as we go forward now with PAGs and that's where we want to be.
[Operator Instructions] And I'm not showing any further questions. I would now like to turn the call back over to Denny Lanfear for any closing remarks.
Thank you, operator. and thank you all for joining us on our Q4 full year 2023 call this afternoon. We're pleased with our progress on all fronts to drive our sales higher, strictly control our expenses, reduce our debt and advance our pipeline. We are entering 2024 with strong upward momentum and a clear organizational focus on attending survival for patients with cancer. We look forward to seeing you all at the upcoming investor conferences and on our next call. Thank you.
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