Q4 2023 Coherus BioSciences Inc Earnings Call
Participants
Jami Taylor; VP of IR; Coherus BioSciences, Inc.
Dennis Lanfear; President and CEO; Coherus BioSciences, Inc.
Paul Reider; Chief Commercial Officer; Coherus BioSciences, Inc.
Rosh Dias; CMO; Coherus BioSciences, Inc.
Theresa LaVallee; Chief Development Officer; Coherus BioSciences, Inc.
Yigal Nochomovitz; Analyst; Citigroup, Inc.
Colleen Kusy; Senior Research Analyst; Robert W. Baird & Co Inc
Michael Nedelcovych; Analyst; TD Cowen
Ethan Brown; Analyst; JPMorgan Chase & Co., LLC
Presentation
Operator
Good day, and thank you for standing by, and welcome to the Q4 2023 Coherus BioSciences Inc. Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. (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, Jamie Taylor, Head of Investor Relations for Coherus.
Jami Taylor
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 Dennis Lanfear, Chief Executive Officer of Coherus; Brian McMichael, Interim Chief Financial Officer; Paul Reider, Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa LaVallee, 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 statement. With that, I'll turn the call over to Dennis Lanfear.
Dennis Lanfear
and thank you all for joining us on the call today. I'm pleased to report to you today a strong fourth quarter results, rounding of an important year of transition for Kroger's as we sharpened our focus on innovative oncology, positioning 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 the strategy in every front position Coherus for long-term sustainable growth of oncology company. We believe this strategy creates long-term shareholder value as we develop and deliver next-generation oncology treatments for patients. We continue on the path that we set forward last year, which is to first drive sales growth and revenues across the oncology portfolio with new product launches of new Danica and like Dorsey. Secondly, simultaneously reduce our spend in any of these costs, further 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 Richter, our Chief Commercial Officer, discuss continued progress on Lebanon and share growth.
Just a moment. Let me start with the spending and head count reductions 2020 for Now last year, we began a multifaceted process of driving new efficiencies through head count 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 plus 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 2020 to 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 by '24 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 one 2024. This payment is now bifurcated into two parts, $4.5 million to be paid next quarter, Q2 2020 for an additional payment of $12.5 million to be paid in Q1 2025.
Such second tranche to be potentially reduced by proceeds on the monetization of CAD toripalimab, right, this reflects our strong partnership and a level of cooperation with Junshi. With respect to realignment of our balance sheet, the reduction of debt, we are pleased with the financial outcome of 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, page 24, the ophthalmology divestiture also allows us to streamline operations today. Coherus is a leaner, more efficient, more nimble organization, difficult to compete in the marketplace with even greater focus, agility and intensity tightly focused on being a sustainable and growing oncology company with like Toro Z, we are gaining predictable and growing high-margin revenues from our innovative product and are able to realize the synergies of having two adjacent oncology products. We congratulate our R&D and regulatory teams for their success in securing three product approvals in 2023 from the FDA.
This is a major accomplishment for any company, especially one of our size, the FDA approvals of new Tenneco auto-injector, you Danica on-body injector. And like towards the initial tranche of cancer, it positioned us for further commercial success in 2020 for capitalizing on synergies. Each of these products aligned to our vision of oncology leadership, each paves the way for the impressive slate of tumor microenvironment focused immuno-oncology assets in our development pipeline.
As Dr. Diab will describe shortly, first-in-class and potentially best-in-class drug candidates has 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, Mr. Paul Reider..
Paul Reider
Thank you, Denny, and good afternoon, everyone. We ended 2023 with strong momentum to the business with the divestiture of the ophthalmology franchise will use this momentum in 2020 for a hyperfocus on our oncology business, drive top line growth of our core oncology assets, Derica and look towards the fourth quarter combined net product revenue was $91.4 million, an increase of 23% over Q. three full year 2023. Net product revenue was $256.6 million, a 22% increase over 2022. I'll speak to each brand and we'll begin with oncology.
Starting with you, Dennis, I'm excited to announce that in Q4, you Danica eclipse $1 billion units sold since its launch is significant and important milestone and demonstration of our customers' belief, the new Tenneco and Coherus has continued commitment to cancer patients. Now that both your datacom auto-injector antibody presentations are launched, our strategy moving forward is to deliver profitable revenue and market share growth fueled by three drivers. First, we think it is the only pegfilgrastim brand with three device options to meet the unique needs of providers and patients.
This strengthens our competitive position and allows us to compete on factors other than price. Second, the launch of new Tenneco on-body in novel and proprietary state-of-the-art delivery system for pegfilgrastim, enabling us to compete now within the entire pegfilgrastim market. And third, we come into 2024 with payer coverage of nearly two times that of 2023, opening up access to significantly more patient lives for disciplined execution of the strategy is delivering a third consecutive quarter of new Datacom 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 identical 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 auto-injector presentation. Identical on-body was launched last month in February, high customer intimate customer demand.
Our 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 a QBO rolling four week identical market share as of March first was 26%, representing an increase of 15 market share points versus the same time period in 2023. Dedicates now a franchise and the only pegfilgrastim brand with three presentation offerings now becoming a total solution for oncology providers.
But with respect to our non-core assets, start with the summary Q4 we sold 3,800 cartons, generate 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. So 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% in Q4, an increase of six market share points quarter-over-quarter.
Let me conclude now let's walk toward busy. Our other core oncology asset block tours in plus chemo is the first and only FDA approved treatment for recurrent or metastatic NPC in all lines of therapy. We launched January second, and it's going well, the demand uptake tracking to expectations. For Q4, we recorded $600,000 in sales based on initial footwear wholesaler stocking to support the commercial launch of PC. is a rare cancer, and we estimate that the USNPC. market is valued up to $200 million at peak, consisting of approximately 2000 recurrent or metastatic MTC patients diagnosed each year and are split evenly between those first line versus second line size.
We thought towards these broad indication in all lines of therapy, we are executing a plan to establish like towards A. plus chemo as a new standard of care and our ambition of backlog towards the available with many NPC patients as quickly as possible. Our conviction in achieving this ambition is bolstered by the following. First, we have strong advocacy from the nation's leading opinion leaders in infancy during the multidisciplinary head and neck cancer symposium. Just two weeks ago, we held over 50 one-on-one in-person meeting with the nation's top opinion leaders.
And over 90% of them have heard are universally that like towards the plus chemo will become the new standard of care in PC based on its FDA-approved indication and the strength of the Phase three data that includes significant improvements on progression-free and overall survival. Second look towards he has achieved preferred listing on both the SCO. and CCN. and PC. guidance. Ross will speak to this further towards he is the only PD-1 for the category one designation with NCCN for first line use the clear differentiator for our tours, a core message Nowak towards promotional message campaign.
Third, we've confirmed payer coverage out to label with payers representing approximately 95% of targeted lives. This includes Medicare fee-for-service for the innovative tools we deploy to identify MTC patients are bearing fruit. We've invested in and deploy real-time claims associated with NPC ICD-10 codes as well as electronic medical record data sources to help identify appropriate NPC patients identified. Of course, these tools alert our field teams in real time and in oncology has an NTC. patients, which then triggers to actions first, along towards the sales call with a doctor.
And second, PayPal targeted branded digital advertising that oncologists in terms of early impact, over 60% of accounts that have ordered block towards the thus far were sourced from the use of these tools last and most important oncologist or prescribing doctors. Since launch, we've had 59 accounts order like Dorsey priced both clinics and hospitals. With respect to the 33 NCCN designated cancer centers 55% have already added like towards the to formulary with the remaining centers in P&T review. And I'm confident we'll have successful outcomes with these centers as well.
Summary, we're excited to become a trusted partner within the head net community to bring new hope for greater survival for NPC patients nationwide. With that, I'll now hand it over to Rosh.
Rosh Dias
Thanks, very much, Paul, and good afternoon. Everyone. past few months have been an exciting time for look towards the which remains a foundational element of our immuno-oncology portfolio following FDA approval on October, the 27th last year, final overall survival data from the pivotal registration study. Jupiter two was published in JAMA in November, showing a hazard ratio for survival of 0.63 favoring a lot towards the arm, which represents a 37% risk reduction in mortality in patients. Living with advanced NPC is overall survival advantage is not only statistically significant, but also very clinically meaningful as NPC patients have not up until now and any approved treatment options for their disease within six weeks of approval.
October was also included in the NCCN guidelines for NPC by the NCCN head and neck panel with a very strong positioning, first-line disease block to date is listed as a preferred therapy and the only checkpoint inhibitor with Category one designation, which does reflect the highest level of evidence and also the uniformity of the panel members decision for the second line and beyond look towards the is the only agent listed as a preferred therapy. And both designations are very reflective of the strength of the data and the clear unmet medical need.
And outside NPC, several additional positive Phase three data sets have been published over the past few months, all in high tier journals, including the near total study in Jama, showing a positive and profound event-free survival benefit favoring toripalimab peri-operative locally advanced non-small cell lung cancer, touch light in Nature Medicine with a positive progression free survival benefit in triple-negative breast cancer and renal George, in the Annals of Oncology showing a PFS benefit in renal cell carcinoma. In addition, positive randomized Phase two data in locally advanced gastroesophageal junction cancer carcinoma.
Has also been published recently in Nature Medicine and very consistent in our communication that our strategic approach in tumors outside NPC will be in developing toripalimab in combination the partnerships and therefore, these positive data sets across additional tumor types sets us up well for partnerships, not only in NPC, but also beyond toripalimab, forming the backbone for investigation in combination with other novel investigational agents. A recent example of this was our inaugural partnership, where we announced that we will be supplying toripalimab combination with Inovio's DNA-based vaccine directed against HPV positive tumors for investigation in a registration enabling study in locally advanced head and neck squamous cell carcinoma, 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 cast as a key to offsetting class and only clinical stage anti IL. 27 molecule, we presented data at ESMO I-O in December in advanced non-small cell lung cancer because those 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 customers in this tumor type in combination with Tory and we are currently enrolling patients in a new arm. In our case, does a Phase Ib study evaluating custirsen in combination with toripalimab in patients with advanced non-small cell lung cancer study is currently open, and we have patients active on study, and we anticipate presenting data from this study either later this year or early next year.
Talking about the cellular carcinoma, we presented the data in first-line HTCISCOGI. January with Coke Zero vote in combination with the teaser and fab, demonstrating an overall response rate of 38% services and 43% by M. resist three complete responses in three subjects recalled 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. It's very encouraging moving forward, we will be investigating has does or in combination with toripalimab and bevacizumab in first-line HCC, which we anticipate will start later this year.
We're particularly encouraged by the clinical activity observed with RIL. 27 antagonist has does or has, in addition to clinical response, demonstrated immune activation in liver and lung patients. Biomarker work from these two clinical studies that have revealed an association of higher levels of IL-27 expression in tumors and kept as a 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 in other tumor types besides lung cancer and HCC that have high levels of IL-27 expression in head and neck cancer, gastric cancer and triple negative breast cancer. I'm told he has demonstrated activity in several of these tumor types.
It supports the potential for additional synergies of the catheters or sorry, combination treatment in some of these additional cancers. Finally, CHS one for our CCR. eight antibody is nearing completion of the dose escalation stage of our Phase one study without any safety concerns on clinical data presented at SITC last year highlighted the potential for targeting CCRA. to deplete T-regs 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 one one four 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 Lavalle.
Theresa LaVallee
Good afternoon, everyone. I'd like to once again thank the FDA for taking the approval action in a timely manner and much faster than the pursuit of a six month time period for the Danica on body supplement after our resubmission in October with both the Danica on body approval and approval of lock Dorsey for all lines of therapy and all patient subsets of nasal fairing GEO carcinoma and coherence oncology franchise is well positioned block towards the next-generation PD-1 inhibitor with potent activation of T cells, including demonstrating significant activity in tumors that are less inflamed our block towards the mechanism of action paper recently published in cancer, immunology immunotherapy describes its with potent activity on T cells.
It is attributed to both high binding affinity for PD-1 and it's finding it a unique Espirito, the SK. loop as PD-1 back toward the is the foundation of our I-O franchise. And we are excited to explore clinical opportunities to extend patient survival with novel combinations, particularly with agents that target mechanisms of PD-1 resistance to immune suppression in the tumor microenvironment. Immunosuppressive M2 macrophages have been well characterized to dampen the immune system. Our CHS. 1,000 program and the anti ILT. four antibody is on track for IND submission.
In the second quarter of this year, we will be presenting the preclinical data from our CHS. 1,000 program at AACR in April. The poster presentation presents the nonclinical characterization of CHS. 1,000, join it is an IoT for selective and potent antibody. It promotes an inflammatory immune response. Tumor types with high expression of ILT. four includes one head and neck, liver breast and ovarian cancer, in addition to advancing new lock towards the indications with combination treatments using the Coherus pipeline targeting TMEDT. and E., we have a number of exciting novel external collab combinations and discussions.
Another important partnering initiative is exploring novel combinations with kind of dose O. and CHS. one went for 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 Brian due to reserve and good afternoon, everyone.
I will briefly review the results for the quarter and the full year. As Paul covered revenues, I will start with costs and expenses. Cost of goods sold increased significantly for the year to $189 million compared to 70.1 in the prior year, driven primarily by our noncore products. Specifically, in Q4 2023, we recorded a $47 million charge for the write-down of slow-moving use memory 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 a mid single digit royalty we pay to Danica. We pay our new dynamic in that sense.
We ended the year with A. 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 digit option fee in Q1 2022 and other de scoped for development costs, which achieved the cost of preparing for launches of new products that happened during 2023 and Sapiens 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 and $4.1 million or 8% compared to a year ago. Decreases primarily reflected savings from lower headcount, partially offset by other costs. For the fourth quarter 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 and marketable securities, we're at $117.7 million as of December 31st, 2023 compared to $192 million at December 31st, 2020 to our 2023 results included $40.5 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 program that we announced in January for Harris is introducing a 2024 guidance range of combined R&D and SG&A expense of $250 million to $265 million.
And 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, but that I'll turn the call back over to Dennis.
Dennis Lanfear
Thank you, Brian. And operator, we're ready to open the line up for questions. Thank you.
Question and Answer Session
Operator
(Operator Instructions) [Michael], Truist Securities.
Okay. This is Michel and one for Robin. Thanks for taking our questions. So I have one on Dennis. And when I look to our results and with the Danica continued to increase, market share is up 7% points quarter over quarter, but our sales are up by 10%. Can you provide more color how much was the effect of net selling price reduction this quarter and for lockdown, the you mentioned the launch is going well. Can you provide more color as in whether the drug has been used more in front-line or second-line settings.
Dennis Lanfear
Thank you very much. Paul will be happy to address your question with respect to Danica And then secondarily, the question of launch of first line versus second line or black Dorsey? Paul?
Paul Reider
Yes, Sean, thanks for your question. Yes, so the up the effect of the net selling price quarter-over-quarter noise in the mid single digit range. And as I mentioned in my remarks, our focus now that we've launched all of us have all three presentations that we're now going to drive the franchise through profitable market share and revenue growth. And that's that's going to be our plan in 2024 and beyond. We're going to do that because we have now all three presentations to access the entire market. We've locked in rate payer coverage and done. We've been able to have a competitive ASP.
So we're looking forward to a successful 2024 with you Danica franchise. Regarding look towards 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 are the 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. A of many of the patients that are it's just gotten chemo in second line, they're going to they're going to get log towards the immediately now. So so we're getting it in both both lines, which is great. And the launch is going very well.
Dennis Lanfear
So and then you can ask Larry, that Pfizer has an ancillary response to your question. The churn of perhaps tech giants like to comment on the selection of like Toro ZIPD. one of the four patients diagnosed with NPC? Yes, happy to do so.
Rosh Dias
And I can tell you as a physician and a few doctors tend to be very evidence-based and data driven. And what I will say is that look towards we have three things that other checkpoint inhibitors do not have. First of all, we have data from a randomized control study and not only do we have data, we have overall survival data, which is actually the gold standard that oncologists look for. I mentioned the 37% risk reduction in terms of and survival advantage with the addition of lot to events. And secondly, of course, we have a label and other checkpoint inhibitors do not have a label and not only that actually nominally do other checkpoint inhibitors or have labels.
There's no other indicated and therapeutic agents for NPC. And thirdly, I'll say to Dennis' point, we also have preferred positioning in terms of NCCN guidelines. We are the only category one I've listed agent for first-line in terms of immunotherapy. And I think that really does reflect the strength of the data and the confidence in the data in this in this area of unmet need.
Dennis Lanfear
Thank you, Roche. Thank you for your question and Sean, thank you.
Operator
Yigal Nochomovitz, Citigroup.
Yigal Nochomovitz
Hi, Denny and team. Thank you for taking the questions on the liver cancer study. I'm just curious, I think the key comp, there is IMbrave one 50 nominally. You are 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 then and the IMbrave one 50 benchmark to be on a go go forward decision with your triple combo. Thank you.
Dennis Lanfear
Thanks. You go. Let's stay as Kent said, yes, it is. So so so you're absolutely right on the IMbrave data with its user base is actually DoD facilities or services license indication right now. So we've shown a response rate, as I said, of $0.38, 43% with and resist. I think we'll be looking at that. But this is the kind of range we're actually looking for for further development rights. I think we've the data that we presented at ASCOGI. in January is exactly what we were looking for. And we will be we will be following up with a and a further study that's going to start to later this year if we're looking at that triplet combination.
Jami Taylor
And if I can add to that, you am 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 Russ mentioned, it both the deepening of response and the improvement in response and the study continues, you evaluate data. And what's important in a 30 patient Phase two 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 tissue resident macrophages. So liver macrophages, Cooper cells, it's really one to note and to dampen the immune response and had activity that was specific in preclinical models to liver cancer and lung cancer translated to 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 have us incredibly excited to do the Tori as does our bad combination.
And maybe one last thing I'll add to safety is always important to say what we can agree. We showed a very, very clean safety profile as well very important.
Yigal Nochomovitz
Thank you, Diego. Okay. Can I follow on? I was just curious on, um, on one on C.H. One one for Teresa. You mentioned the dose escalation and then you're going to do the combo with Tory. And I think in your slide deck in early January, you'd indicated there'd be some data in the first half of the year for the Phase one wasn't sure if that was still our expectation or just help us understand that, please. Thank you.
Dennis Lanfear
Can we actually plan to present that dose escalation in the first half of the year at a major medical conference setting. Thank you. Okay.
Operator
Colleen Kusy, Baird.
Colleen Kusy
Hi, thanks for taking our questions. I think revenue guidance is something you've given in the past, and 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.
Dennis Lanfear
I am. Thanks, Galina. I'll take that one and let Paul backfill. I think the primary issue is that we have freshly launched the identical on-body. We're very excited about the enthusiasm that's been received in the market, but the ultimate trajectory of that across 2024 is not yet known. It's only been out in the market in oh four about a month. As Paul pointed out, though, we have seen 100, 29% increase with respect to the auto-injector uptake in the trailing four week data or your dedicated itself is up north of 25% up from Q4. So that's all very, very compelling.
And I think that would give us greater certainty with respect to the trajectory and the steepest trajectory once we get a little further into Q. one and get that below us. And 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 like Dorsey. As Paul indicated, we're very pleased with the launch of our digital strategy over the last two years of basically on developing a relationship with a patient. It's very very good. And we are very pleased that 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 and it takes a month or two to get on the formulary for IP. and T. committee of the major hospital someplace the East Coast or something. So we're happy to do that. But we just would like a little not probably another quarter under our belts before we go ahead and we do have projections with respect to revenue, but on the topic of revenue, though, I would make one key issue and what would 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 revenues, for example. But like towards the end, you Danica will lead to greater profitability as we go into the backside of the year. And as Paul said, that's really where we're focused. We want to drive the top line, but we also believe that the quality of revenues, especially with a product like back towards EV, is going to be far better, more stable and more sustainable, then your typical biosimilar.
Colleen Kusy
That's helpful. Thank you. 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 it? Or is that guidance for cash flow positive in 2024 or not specifically maybe dependent on revenue or others and without being able to predict revenues?
Dennis Lanfear
I can't really predict cash flow positivity. But I would just make the key point that I think that we 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 headcount over the past two years from 22 to 23 to 24 from 360 to 290 and now targeting 215 FTEs by the end of this year, I mentioned ARIA, 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 revenue is higher, as you can see.
And then lastly, we're making very good progress reducing our interest costs, Brian recapitulated that for us by $0.7, a 70% reduction in our fixed term loan interest costs where we're paying silver at plus eight. I think that's really very significant. So we're going to continue in this direction and just where those two lines cross, we can't quite predict, but that's our North Star and our guiding light where we're going.
Colleen Kusy
That's helpful. Thanks for taking our questions.
Operator
Michael Nedelcovych, TD Cowen.
Michael Nedelcovych
I thanks for the question on. Do 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 trial? Thank you.
Dennis Lanfear
Thanks for the question. Mike. I'll get back to the Valley address that, Theresa.
Theresa LaVallee
Yes, I had my accounting where, as we've talked about, I think as Dan said, a lung cancer study is open. I mean, that's a home run kind of strategy, a high bar given the monotherapy activity as cash does, though, which was not expected to see in cancer patients, that Tory combination should show by data by the end of this year, early next year. We're also looking at earlier lines of treatment based off of the Tori positive data trials such as Neo torch and further explore lung cancer, the HCC study, we plan to open later this year.
So that data next year, as we mentioned, the one one for the CCR. eight antibody will be presenting and next quarter. So I think the news flow from that plus a number of partnerships, we've already announced the NOVA one, you'll see other ones and that will be generating data next year. It's also been presented. And then part that isn't appreciated about toripalimab is Junshi, continues to develop it and is now all of their studies are multi-regional clinical trials, which would make it and acceptable to the FDA. And so they have a Phase three ongoing with their pipeline.
So we'll be watching, but 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 three metrics, so later in the next couple of years.
Thanks, Michael.
Operator
[Ethan Brown], JPMorgan Chase.
Ethan Brown
Ethan Brown on for Chris Schott. Thanks for taking our question. Just to start off, can you maybe offer some color on how you're thinking about OpEx looking past 2024 and get them on one hand, you have the pipeline that you're trying to progress and then balancing that against the company's path to profitability. And then I have one more question after that?
Dennis Lanfear
Well, I'll let Brian and I think, Mike, I'll take a shot at that, Brian.
Paul Reider
As I said, we didn't and we're not providing guidance beyond 24 at this time. As we get into as we start 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 then inform and we look forward to 2026.
Ethan Brown
And I would say after we achieve profitability and cash flow positivity, we intend to stay profitable if that's your question, right?
Dennis Lanfear
Yes, I'd like I would add I would offer you one other. I don't know if you wanted to point, which is like towards the we expect like Dorothy to reach peak sales and 2.5 to 3 years, and we further expect a continued increase in market share for you Danica over the short to medium term so both 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.
Ethan Brown
That's very helpful. Thank you. And then just pivoting over to you Dennis on, 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 and in the market?
Yes, that's a that's a very, very, very, very good question. A very it's a group of Durbin Nuance is I'll let Paul address. That particular issue is three presentations and our ability to have sustainable franchise in the market and support pricing policy.
Dennis Lanfear
Yes, Chris, thanks for your question. So our whole strategy with you, Danica with the three presentations is to give the customers a choice so that they can choose the presentation that meets their unique needs of the patient and the doctor, and that's whether it was a brand can do that. We saw a pretty pretty impressive growth with auto-injector in the fourth quarter, driven largely in the clinic market and don't. And that's because now we got nurses that were using it and great experience with it like 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 datacom, it was still under 10% sort of where, of course, continue to be the prefilled syringe presentation that as we see it 2024, that's all going to take a new shape now that we have our on-body device launch as well as the auto-injector into prefilled syringe that, as I mentioned in my remarks, Chris know, moving forward in year six of this brand's life cycle, you know, we're getting that second wave of growth. And our focus is really going to be around driving profitable revenue and market share growth. And we are confident we're going to do that 2020 onwards, if any.
Other data points I would make is we play the long-term game here with the generic market. As Paul said, we're six years since we invested significantly both in the auto-injector, some $25 million in years past, it took us at least three or four years to bring forward the on-body. That was probably a $35 billion investment and 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 and 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 four week 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 three presentations. We're positioned for markets, stability and sustainability as we go forward now with pegfilgrastim, and that's where we want to be.
Ethan Brown
Thank you, guys, for the question.
Operator
(Operator Instructions) One moment for questions. And I'm not showing any further questions. I would now like to turn the call back over to Dennis Lanfear for any closing remarks.
Dennis Lanfear
Thank you, operator, and thank you all for joining us on our Q4 and full year 2023 call this afternoon, we are pleased with our progress on all fronts to drive our sales higher, strictly control our expenses, reduce our debt and advanced our pipeline. We are entering 2024 with strong upward momentum and a clear organizational focus on extending survival for patients with cancer. And we look forward to seeing you all at the upcoming investor conferences in our next call. Thank you.
Operator
Thank you for your participation. You may now disconnect.
