Coherus BioSciences, Inc. (NASDAQ:CHRS) Q4 2023 Earnings Call Transcript

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q4 2023 Earnings Call Transcript March 13, 2024

Coherus BioSciences, Inc. misses on earnings expectations. Reported EPS is $-0.62 EPS, expectations were $-0.21. CHRS isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good day, and thank you for standing by. Welcome to the Q4 2023 Coherus BioSciences, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [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.

Jamie 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 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 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 to 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 Denny.

Dennis Lanfear : Thanks, Jamie, 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, 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 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 treatments for patients. We continue on the path that we set forward last year, which is the first drive sales growth and revenues across the oncology portfolio with new product launches of UDENYCA and LOQTORZI.

Secondly, simultaneously reduce our spend in any 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, discuss continued progress on revenue 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 plus R&D spent for 2024 of $250 million to $265 million, which is 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 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 two parts, $12.5 million to be paid next quarter, Q2 2024, and additional payment of $12.5 million due paid in Q1 2025, such second tranche to be potentially reduced by proceeds from the monetization of Canadian to our cortailment rights. This reflects our strong partnership and high level of cooperation 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 2024.

The ophthalmology divestiture also allows us to streamline operations. Today, Coherus is a leaner more efficient and more nimble organization, capable of competing 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 two adjacent oncology products. I want to 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 the UDENYCA auto-injector, UDENYCA on-body injector and LOQTORZI and nasopharyngeal cancer have positioned us for further commercial success in 2024, capitalizing on synergies.

Each of these products aligns to our vision of oncology leadership and each paves the way for the impressive slate of tumor microenvironment focused immuno-oncology assets in our development pipeline. As Dr. Dias will describe shortly, 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, Mr. Paul Reider. Paul?

Paul Reider : Thank you, Denny. Good afternoon, everyone. We ended 2023 with strong momentum to the business with the divestiture of the 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. And I’ll speak to each brand and we’ll begin with oncology starting with UDENYCA. I’m excited to announce that in Q4, UDENYCA Eclipse, 1 million units sold since its launch, a significant and important milestone in demonstration of our customer’s belief in UDENYCA and Coherus’ continued commitment to cancer patients.

Now that both UDENYCA auto-injector and on-body presentations are launched, our strategy moving forward is to deliver profitable revenue and market share growth fueled by three drivers. First, UDENYCA 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 UDENYCA on body, a novel and proprietary state-of-the-art delivery system with pegfilgrastim enabling us to compete now within the entire pegfilgrastim market. Third, we come into 2024 with payer coverage of nearly 2x that of 2023, 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 autoinjector. 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 auto-injector presentation. UDENYCA on-body was launched last month in February. 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 three presentation offerings now becoming the total solution for oncology providers. With respect to our non-core assets, I’ll start with CIMERLI. 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 till the implementation of the Inflation Reduction Act 2025. Regarding CIMERLI, 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 with LOQTORZI, our other core oncology asset. LOQTORZI plus chemo is the first and only FDA approved treatment for recurrent or metastatic 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 2,000 recurrent or metastatic NPC patients who are diagnosed each year and are split evenly between those in first line versus second line plus. With LOQTORZI’s broad indication in all lines of therapy, we are executing a plan to establish LOQTORZI plus chemo as a new standard of care and our ambition to make LOQTORZI 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 NPC. During the multidisciplinary Head and Neck Cancer Symposium, well 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 affirmed universally that LOQTORZI plus chemo will become the new standard of care at NPC based on its FDA approved indication and the strength of the Phase 3 data that includes significant improvements on progression free and overall survival. Second, LOQTORZI has achieved preferred listing on both the ASCO and NCCN NPC guidelines. Rosh will speak to this further, but 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 MPC patients are bearing fruit. We’ve invested in and deployed real-time claims associated with MPC ICD-10 codes as well as electronic medical record data sources that help identify appropriate MPC patients, the identified of course. These tools alert our field teams in real time when an oncologist has an MPC patient, which then triggers two actions. First, a LOQTORZI sales call with that doctor and second, hyper 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 important, oncologists are prescribing LOQTORZI. Since launch, we’ve had 59 accounts order LOQTORZI comprised of both clinics and hospitals. With respect to 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 within the head and neck community and to bring new hope for greater survival for MPC patients nationwide. With that, I’ll now hand it over to Rosh.

Rosh Dias : Thanks very much, Paul, and good afternoon, everyone. The past few months have been an exciting time for LOQTORZI, which remains the foundational element of our immuno oncology portfolio. Following FDA approval on October 27 last year, final overall survival data from the pivotal registration study JUPITER-02 was published in JAMA in November, showing a hazard ratio for survival of 0.63 favoring the LOQTORZI, which represents a 37% risk reduction in mortality in patients living with advanced MPC. This overall survival advantage is not only statistically significant, but also very clinically meaningful as MPC patients have not up until now had any approved treatment options for their disease. Within six weeks of approval, LOQTORZI was also included in the NCCN guidelines for MPC 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 and also uniformity of the panel member’s decision. The second line and beyond, LOQTORZI is the only agent listed as a preferred therapy and both designations are very reflective of both strength of the data and the clear unmet medical need. Outside MPC, several additional positive Phase 3 data sets have been published over the past few months, all in high tier journals, including the NEOTORCH study in JAMA, showing a positive and profound event free survival benefit favoring toripalimab, perioperative, locally advanced non-small cell lung cancer. TORCHLIGHT in Nature Medicine with a positive progression free survival benefit in triple negative breast cancer and RENOTORCH at the Annals of Oncology showing a PFS benefit in renal cell carcinoma.

In addition, positive randomized Phase 2 data in locally advanced gastroesophageal junction carcinoma has also been published recently in Nature Medicine. We’re very consistent in our communication that our strategic approach in tumors outside MPC 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 MPC, but also beyond, with toripalimab forming 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’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 casdozokitug, 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, where casdozo 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 casdozokitug in this tumor type in combination with taurie and we are currently enrolling patients in a new arm in our casdozokitug Phase 1b study evaluating casdozokitug in combination with toripalimab in patients with advanced non-small cell lung cancer.

This 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. For hepatocellular carcinoma, we presented casdozokitug data in first line HCC at ASCO GI in January with casdozokitug in combination with atezo and bev demonstrating an overall response rate of 38% by resist and 43% by m resist, including complete responses in three 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 casdozokitug 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, casdozokitug has in addition to clinical response, demonstrated immune activation in liver and lung patients. The biomarker work from these two clinical studies have revealed an association of higher levels of IL-27 expression in tumors and casdozokitug 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 include head and neck cancer, gastric cancer and triple negative breast cancer. LOQTORZI has demonstrated activity in several of these tumor types and supports the potential for additional synergies of the casdozokitug/tori combination treatment in some of these additional cancers.

Finally, CHS-114, our CCR8 antibody is nearing completion of the dose escalation stage of our Phase 1 study without any safety concerns. Non-clinical data presented at SITC last year highlighted the potential for targeting CCR8 to deplete Treg 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.

Theresa LaVallee : 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 PDUFA 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 Coherus 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 mechanism of action paper recently published in Cancer Immunology Immunotherapy describes its potent activity on T cells that is attributed to both high binding affinity for PD-1 and its binding at a unique epitope, the FG loop of PD-1.

LOQTORZI is the foundation of our IO 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 due to immune suppression in the tumor microenvironment. Immune suppressive M2 macrophages have been well characterized to dampen the immune system. Our CHS-1000 program and anti-ILT4 antibody is on track for IND submission in the second quarter of this year. We’ll be presenting the preclinical data from our CHS-1000 program at AACR in April. The poster presentation presents the non-clinical characterization of CHS-1000 showing it as an ILT4 selective and potent antibody that promotes an inflammatory immune response. Tumor types with high expression of ILT4 include lung, head and neck, liver, breast and ovarian cancer.

In addition to advancing new LOQTORZI indications with combination treatments using the Coherus pipeline targeting 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.

Bryan McMichael: Thank you, Theresa, and good afternoon, everyone. I’ll 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 $159 million compared to $70.1 million in the prior year, driven primarily by our non-core products. Specifically, in Q4 2023, we recorded a $47 million charge for the write-down of slow-moving CIMERLI inventory and related firm purchase commitments. In addition, CIMERLI 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 CEMERLI 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 $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 CEMERLI 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.

Dennis Lanfear: Thank you, Bryan. Operator, we’re ready to open the line up for questions.

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Q&A Session

Operator: [Operator Instructions]. Our first question comes from Robyn Karnauskas with Truth Securities.

Unidentified Analyst: Hey, this is Nishant.I’m 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?

Dennis Lanfear: 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?

Paul Reider: 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 three 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 three 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, 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, Rosh would like to comment on the selection of LOQTORZI as a PD-1 for patients diagnosed with NPC.

Rosh Dias: 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 three 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 oncologists 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 and it’s not a label, there’s no other indicated therapeutic agents for NPC. And thirdly, I’ll say steady 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 in the data in this area of unmet need.

Operator: Next question comes from Yigal Nochomovitz with Citigroup.

Yigal Nochomovitz: 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?

Dennis Lanfear: Thank you, Yigal. Dias can address that.

Rosh Dias: Yes. So you’re absolutely right. The IMbrave data with atezo-bev is actually the only –atezo-bev is a license indication right now. So we’ve shown a response rate, as I said, of 38%, 43% with M-Resist. I think we’ll be looking at this is the kind of range we’re actually looking for further development, right? So I think with the 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.

Theresa LaVallee: 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 response and the study continues to evaluate data. But important in a 30-patient Phase 2 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 Kupffer 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 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 has incredibly excited to do tauri atezo-bev combination.