Good day and thank you for standing by. Welcome to the Coherus Biosciences Third Quarter 2023 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. Please go ahead..

Good afternoon, everyone, and thank you for joining us. I am Jamie Taylor, Coherent's new Head of Investor Relations. I'm happy to be with you today. We issued a press release earlier today announcing our financial results for the third quarter of 2023.

This release can be found on the Coherus BioSciences website and is also attached to the Form 8-K that we filed with the SEC today. Today's call includes forward-looking statements regarding Coherus' current expectations about future events.

These statements include, but are not limited to, our ability to gain approval for multiple new products and launch them, projections of expenses and revenue, projections of future market share or demand for any product, our expectations for market opportunity and the timing of our return to a cash flow positive.

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 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. Third quarter 2023 results are not necessarily indicative of results for future periods With me on today's call are Denny Lanfear, CEO of Coherus; Dr.

Theresa LaVallee, Chief Development Officer; Dr. Rosh Dias, Chief Medical Officer; Paul Reider, Chief Commercial Officer; and McDavid Stilwell, Chief Financial Officer. I will now turn the call over to Denny..

Thank you, Jamie, and welcome to the team, and thank you all for joining us today on our Q3 2023 earnings call. We continue to make good progress on our over-arching strategy. LOQTORZI, our PD-1 inhibitor, has now improved.

The Surface Oncology acquisition is now completed, providing us a competitively positioned development program focused on the tumor microenvironment. Similarly, our Lucentis biosimilar after garnering its cut cost continues to gain share in sales and our UDENYCA franchise has returned to growth.

However, even as we progress on the overarching strategy, we are cognizant that our revenues and our expenses was come into alignment. Progress has been major also. This quarter saw a 27% increase in revenues over last quarter to $74.6 million, representing a 64% quarterly increase year-over-year.

While year-to-date SG&A plus expenses was reduced by some 30% from the same period last year.

So while we plan to expand LOQTORZI utilization beyond NPC by developing it in combination with other synergistic therapeutics, including our own, this internal development will be constrained until mid-2024 as we continue to reduce expenses and take profitability.

And while we plan to enter into partnerships with other companies interested in combining their novel assets with like LOQTORZI or our T&E assets, we do not foresee sharing clinical development costs, which would increase our R&D expenses.

So even as revenues increased from the growing number of commercial products across the board, we will seek opportunities to constrain and reduce expenses as we pursue profitability. With that, I'll hand the call over to Paul, our Chief Commercial Officer.

Bob?.

first, to maximize the conversion of existing Lucentis business; and second, to grow share through new patient starts and the conversion from other anti-VEGF products. Execution against this plan remains strong as we report net sales in Q3 of $40 million, an increase of 50% quarter-over-quarter, driven by strong demand.

CIMERLI market share within the ranibizumab class was 28.6%, an increase of 11.6 market share points quarter-over-quarter. We also announced that CIMERLI passed a major milestone.

For the first year of launch, we sold over 100,000 doses to retinal specialists, which reinforces the retinal community's receptivity of biosimilars and the desire for a safe and effective biosimilar option to Lucentis. Summary, total 2023 net sales for CIMERLI through Q3 were $73 million.

So we refer guidance that CIMERLI net sales will exceed $100 million for 2023. Now on to UDENYCA.

As stated previously, our strategy has been to fortify our base prefilled syringe business while making pricing share trade-offs in order to maintain a competitive ASP in advance of the launches of both the auto-injector and on-body presentations, respectively. We guided that UDENYCA demand and market share will return to growth this year.

Based on our strong execution of this plan, I'm pleased to now report two consecutive quarters of UDENYCA revenue and market share growth. Q3 net sales were $33 million, an increase of 4% quarter-over-quarter, driven by increased demand, partially offset by lower net selling price.

Market share grew to 16.5%, an increase of 4.3 market share points quarter-over-quarter. Both demand and market share gains were driven primarily from our core prefilled syringe presentation and occurred across all segments of the business.

Also in the quarter, we launched the innovative UDENYCA auto-injector and are working with accounts on how to best position and operationalize the auto-injector within their respective clinical process approach.

Since commercial launch, we've had over 300 accounts for the UDENYCA auto-injector and are seeing a consistent flow of new account ordering every week. We expect increases in UDENYCA auto-injector demand as the launch progresses.

Another positive development that occurred in the quarter is payer coverage, which significantly increased as both UDENYCA prefilled syringe and auto-injector presentations were newly added on to a number of commercial and Medicare Advantage plans. Effective start dates of this expanded coverage vary and range from September 2023 to January 2024.

But regardless of the start date, these contracts extend through calendar year 2024, significantly expanding UDENYCA's access going into next year. Regarding our novel UDENYCA on-body device, we are awaiting FDA approval and will launch directly thereafter. UDENYCA is now a franchise.

And following the anticipated approval, UDENYCA on-body injector will be the only pegfilgrastim brand to three presentations offerings, becoming the total solution for oncology providers. This will enable us to compete directly with Neulasta Onpro, which retains 42% of the market. Turning now to YUSIMRY, a biosimilar to Humira.

The high cost of adalimumab treatment remains a problem for the health care system and for many patients. Our patient-centric strategy is to provide YUSIMRY at a signal, transparent, low price.

We launched YUSIMRY on July three and were the innovators of a low list price strategy, launching at a list price of $995 per carton for two auto injectors, representing a discount of more than 85% to Humira.

As part of our low list price strategy, we established partnerships, our Mark Cuban Cost Plus Drug Company and through its Team Cuban Card, and independent retailers nationwide. We also signed an agreement with Superior Biologics, a specialty pharmacy who services more than 1.5 million patients across the country.

We will continue to pursue partnerships with organizations, who look for low list price alternatives as we build our YUSIMRY business from the bottom-up. In Q3, we sold 2,300 cartons at YUSIMRY, generating net sales of $1.4 million.

While the market formation period for biosimilar adalimumab is still in its early stages, Humira retains formulary position for nearly all PBM and health plan formularies in 2023, and likely in 2024.

Therefore, we expect slower growth for Humira biosimilars through 2024 and then greater acceleration of biosimilar adalimumab adoption with the implementation of the Inflation Reduction Act in 2025.

IRA will shift financial risk during the catastrophic phase of the benefit from the government to the Part D plans, which could affect health plans consider their formulary selections.

Finally, let me reiterate our excitement about the approval and upcoming launch of LOQTORZI, the first and only FDA-approved treatment for patients diagnosed with relapsed or metastatic NPC.

We've commenced launch activities and are working to ensure that patients and providers have access to LOQTORZI as soon as product is in the channel, which we estimate to be in the early Q1 time frame. We share with you now some more details about the NPC market opportunity for LOQTORZI. First, the NPC market.

We estimate that approximately 2,000 relapsed/metastatic NPC patients in the U.S. diagnosed each year. And the split is even between those in the first line versus second line plus. With LOQTORZI's broad indication, we can access all of these patients and promote across all lines of therapy, including first line. Second, the prescriber base.

NPC is fairly concentrated with approximately 2,200 oncologists accounting for 80% of NPC treatment. 60% of the business is in the hospital setting and 40% is in the clinic. We know these doctors, and our existing oncology team currently calls on all of the accounts for these doctors' practice.

So the call points are highly efficient and synergistic with UDENYCA. Third, the current treatment landscape for NPC. Claims data suggests that chemo-only regimens are prescribed 60% of the time, which provides an immediate opportunity for LOQTORZI.

We'll target these treating physicians and position LOQTORZI to be added to the existing chemo regimen, irrespective of the line of treatment.

For the 40% where a combination of chemo and PD-1 is used will position LOQTORZI as the preferred PD-1 and the new standard of care regimen based on our approved indication and the totality of the evidence, which includes overall survival data. Finally, patient engagement.

Through npcfacts.com, we've enrolled a community of over 2,100 NPC patients or caregivers, and we'll appropriately communicate branded information about LOQTORZI, so they are informed and educated with speaking with their doctors about their individual treatment plans.

Patients will also be supported through LOQTORZI solutions for patient services hub that can be accessed via loqtorzi.com. These are plans that go live next week. We look forward to updating you on our progress as the LOQTORZI launch progresses. With that, I'll now hand it over to Theresa..

Thank you, Paul, and good afternoon, everyone. I want to once again thank the FDA for acting so quickly to approve LOQTORZI following completion of the overseas inspection. With Toripalimab approval now secured, we are continuing to collaborate with the FDA to complete their review of our final outstanding BLA for the UDENYCA on-body injector.

As previously disclosed, UDENYCA OBI supplement received a complete response letter from FDA on September 21, 2023, solely due to a third-party seller's inspection status. We were very pleased that our third-party manufacturer was able to resolve this with urgency, and we were able to resubmit the UDENYCA OBI supplement to FDA in under-two weeks.

It is important to note only deficiency in the CRL from FDA was the third-party manufacturer indicating that clinical and manufacturing data were complete. Given there isn't any new information for FDA to review, we anticipate approval this year or in the early part of 2024 and anxiously await the resource-constrained FDA to take action.

Based on PDUFA, the review would be given a 6-month clock. However, the agency has communicated to us that they expect to act significantly sooner. I will now briefly review the data for Toripalimab and our other I-O candidates we recently presented at ESMO and SITC.

LOQTORZI is a next-generation PD-1 inhibitor with a potent activation of T cells, including demonstrating significant activity in tumors that are less inflamed such as small cell lung cancer, as was recently highlighted in an oral presentation at ESMO.

Coherus has presented our preclinical mechanism of action studies at the AACR-EORTC-NCI triple meeting, and last week at the SITC conference comparing Toripalimab to pembrolizumab and demonstrated in multiple assays that Toripalimab treatment resulted in statistically significantly higher T cell activation than pembrolizumab.

Toripalimab's potency on T cell activation is consistent with a 12-fold higher binding affinity to PD-1 than pembro. Additionally, the unique epitope of Toripalimab at the FG loop of the PD-1 may also contribute to its higher potency.

LOQTORZI is the foundation of our I-O franchise, and we are excited to explore clinical opportunity to extend patient survival with novel combination, particularly with agents that target mechanisms of PD-1 resistance due to immune suppression in the tumor microenvironment.

At the SITC conference last week, we also presented two additional posters characterizing the mechanism of action of casdozokitug, our IL-27 antibody, and CHS-114, our cytolytic anti-CCR8 antibody.

The casdozo poster highlighted the interferon signaling life properties of IL-27 and importantly described biomarkers that may be useful for evaluating cancer patient treatment with casdozo.

The CHS-114 studies support that preclinical treatment with an anti-CCR8 antibody due to depletion of Treg cells in the tumor and conversion of cold tumors to hot. These data position us well for clinical development of both of these programs with LOQTORZI.

Our third program targeting immune suppressive mechanisms in the tumor microenvironment is our CHS-1000 anti-ILT4 antibody program. We continue to progress our IND-directed studies and plan to file the IND in the first quarter of 2024. I'll now turn the call over to Rosh..

casdozo, first-in-class and only clinical stage I-27; and CHS-114, our CCR8. Firstly, with respect to casdozo. As a reminder, this asset has shown monotherapy activity in Phase I study in PD-L1 refractory non-small cell lung cancer and also combination activity with Atezo and Bev in hepatocellular carcinoma, data that was disclosed earlier this year.

Updated data from these patients are anticipated to be presented in the coming months, both for non-small cell lung cancer and hepatocellular carcinoma.

We will be taking this early indication of activity forward with a Phase Ib combination study of casdozo with Toripalimab, which is currently in startup and which we anticipate being active in the coming months.

With respect to CHS-114, this asset is currently in the clinic in dose finding, and we have safely proceeded through several dose levels without untoward safety concerns. We will continue dose escalations before moving on to dose optimization and further studies in head and neck carcinoma, a tumor type where the disease linkage is strong.

Regarding our TIGIT, our Phase I/IIa study looking at the Toripalimab TIGIT combination has completed the enrollment of its initial cohort of subjects in the U.S. with an acceptable safety profile.

We will hold further enrollment into this trial, while we analyze the data from the ongoing patient pool and assess evolving data from competitor trials in order to be able to complete a robust portfolio prioritization whilst at the same time, continuing our clinical development efforts with LOQTORZI in combination with casdozo and CHS-114, together with continued development of our ILT4, which now gives us the opportunity to target not only the T cell with LOQTORZI but also the tumor microenvironment in a potentially synergistic fashion.

I'll now turn the call over to McDavid..

Thank you, Rosh. I'll briefly review third quarter results before discussing our updated 2023 guidance. As Paul detailed earlier, today, we are reporting a 27% increase in net sales across our three marketed products.

Net revenue was $74.6 million during the three months ended September 30, 2023, and included $33 million of net sales of UDENYCA, $40 million of net sales of CIMERLI, $1.4 million of YUSIMRY net sales as well as approximately $200,000 in royalties we received from a license to our adalimumab formulation.

Cost of goods sold for the three months ended September 30, 2023 was $32.7 million and gross margin was 56%. Recall that UDENYCA COGS includes a mid-single-digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid-50% royalty on gross profits.

We continue to focus on keeping tight control of our operating costs, and research and development expense for the three months ended September 30, 2023 and 2022 were $25.6 million and $45.8 million, respectively.

The significant decline in R&D expense compared to the prior year quarter primarily resulted from the reduction in scope of the Toripalimab collaboration agreement.

The capitalization of certain YUSIMRY costs into inventory in 2023 that were expensed as R&D prior to mid-2022 as well as $5.2 million in personnel and stock-based compensation expense due to lower headcount. Selling, general and administrative expense increased by $3.4 million compared to the year ago quarter to $48.2 million.

The increase was attributable to an increase in professional services fees of $4.7 million driven by the Surface acquisition and third-party processing fees for multiple products being commercialized, partially offset by a $1.9 million reduction in employee and consultant costs due to a lower average headcount as we continued to realize savings from the cost-cutting program we announced in March.

As we launch new products, we are carefully controlling incremental spending to ensure the investment is appropriate for the opportunity and that we realize the efficiencies inherent in our portfolio.

For example, our YUSIMRY strategy is to build a business with customers attracted to our lowest price adalimumab offering, and we have very low operating expenses associated with YUSIMRY. Toripalimab will be efficiently launched using the same commercial infrastructure market in UDENYCA.

As our product revenues increase and we continue to constrain operating expenses, we expect operating losses will continue to moderate. For the third quarter of 2023, we reported a lower net loss of $39.6 million or $0.41 per share compared to a net loss of $86.7 million or $1.11 per share for the same period in 2022.

Cash, cash equivalents and investments in marketable securities were $131 million as of September 30, 2023 compared to $192 million at December 31, 2022. We are projecting continued sales growth and expect fourth quarter net sales of $85 million to $95 million.

For the full year 2023, we are reducing our earlier revenue guidance to a range of $250 million to $260 million, primarily as a result of the delay in approval of UDENYCA on-body injector, which we now expect to launch in the early part of 2024 following potential approval.

We continue to tightly manage our expenses, and we are today reducing our combined R&D and SG&A expense guidance from the earlier range of $315 million to $335 million to a new range of $300 million to $310 million, including $40 million to $45 million of stock-based compensation expense.

This range also includes the addition of Surface Oncology-related operating expenses since the closing of the acquisition in September, and it excludes any upfront or milestone collaboration payments or the closing cost of the Surface Oncology acquisition.

Although we are not yet introducing revenue or expense guidance for 2024, we do expect lower expenses in 2024 compared to 2023 as well as continued growth in net product revenues as we continue to execute on our product launch plans.

We are focused on ensuring the success of our commercial launches, and we will continue to maintain tight control over our operating expenses as we manage Coherus back to being cash flow positive over the course of 2024. I'll now hand the call to Denny for closing remarks prior to questions..

Thank you, McDavid. Coherus is now one of the small number of I-O companies with approved commercial stage PD-1 inhibitor and a competitively positioned development program. We believe these are the two critical success factors for any company aspiring to be a leader in I-O.

We're now revenue generating immuno-oncology company with growing sales across a number of products, with an increasingly diversified revenue base. We look forward to keeping you apprised of our progress. Operator, we're ready for the questions..

Thank you. [Operator Instructions] Our first question comes from the line of Robyn Karnauskas with Truist Securities. Your line is now open..

Hi, guys. Thanks for taking my question. I mean given the stock reaction, I think you were focused on consensus. So I have two questions for you on that. For UDENYCA, scripts were up actually. And then you noted on the prepared remarks that you took, I think, pricing concessions.

Can you help us understand some of the dynamics going on with UDENYCA? On CIMERLI, it seems like on the Regeneron call -- like, where are you taking share? Does it seem like you're taking share from them? Did you have any impact from them? And my last question is like a big picture question.

You guys have guided like being cash flow positive next year, which is like a big thing for you.

Is that still on track? Or do you want to withhold that guidance?.

Robyn, thanks very much. So your first question with respect to UDENYCA is that the scripts up, but what was the impact of pricing. And then with respect to CIMERLI, where is the share coming from the last day of the guidance. I'll let Paul first address the dynamics of the UDENYCA market and address the question of where the CIMERLI share came from.

Paul?.

Thanks, Denny. Thanks for your question, Robyn. Yes, the UDENYCA business, Robyn, as we've guided with the launches and our strategy that market share and demand growth will increase in 2023. We reported that increase today. That's driven by a 30% increase in demand quarter-over-quarter.

What we've always guided to was the price impact, which was always a little bit harder to predict in the competitive markets. In the third quarter, we saw a net selling price decline of about 9%. So that's the puts and takes. We do expect continued market share and demand growth occurring over the fourth quarter and into 2024 driven by two things.

The first is the enhanced payer coverage, which has increased substantially for the brand as well as the expected launch of now our on-body device. So between the auto-injector and the on-body, if approved, we'll have two shots on goal to go after that Onpro share, which is at 42%.

Regarding CIMERLI, we're executing on our strategy of targeting the Lucentis business. And that's the first part of our strategy. So the majority of our business is coming from a combination of share from Lucentis, but also Avastin, which is also a target for us. That represents 40% of unit share.

We're getting business from both of those -- in addition to new patient starts, those represent the largest sources of our business, in line with our strategy..

Yes. I would like to answer the -- yes, your last part of your question. With respect to returning to profitability and being cash flow positive next year, as I indicated in my opening remarks, we're very cognizant of bringing our expense structure in line with our revenue structure.

This quarter also we guided downward with respect to our invested expenses, and we will continue to see reduced expenses next year even as revenues grow. We have not offered formal guidance of becoming profitable for next year.

And once we get past, I think, our first quarter call and we look at how the launches are going potentially of on-body and of LOQTORZI, we'll be happy to revisit that for you. But we are very, very focused on driving the business back to cash flow positive and back to profitability. As you've seen, expenses are down and sales are up..

Super helpful. And just a follow-up on UDENYCA. Like as we think about on-body device launching, just to make sure we're all in the same realm, how do you think about the impact of pricing when you launch that? Could we see continued price declines? And shout-out to Theresa, like last call you did, again, congrats [ on inventory ].

I'm not asking one on inventory, but congrats, but maybe just like you maybe delve deeper into UDENYCA so that we can all model it better next quarter and for next year?.

Yes. Thanks, Robyn. So our focus here is we're going to be going into 2024, year six of the UDENYCA life cycle is maximizing long-term revenue and profitability of this franchise.

So if and when the on-body device is approved, we will launch that into each of the segments of the business where we believe we'll have a competitive value proposition, but also be able to maintain discipline with our pricing so that we can drive profitability for this franchise.

So we're going to be looking at every segment, but clearly be watching the market dynamics that occur in each of those segments, whether it's the clinic or the hospital and approach our launch accordingly..

Robyn, I would also add that we expect to see significant market share gains with UDENYCA next year and we're very cognizant of the margins in obtaining those gains. As you've seen, the peer coverage has significantly increased over the past quarter. We expect to see that next year.

But the overarching message for the UDENYCA franchise is that the long-term strategy is succeeding. As Paul indicated, we're near five or six on this franchise. We were very, very careful with our pricing in order to have a strong price upon which to launch our additional presentations. That has been successful.

And even as other competitors who gave away more prices have now fallen away and we are emerging in this market..

Do you think you're going to have to lower price further? Just out of curiosity, I'm just trying to make sure that all the analysts are on the same page, we want to make sure. We watch script growth and then if you miss on price, should we predict a little bit more price....

We would seek to protect price even as we go forward, having all three presentations..

Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is now open..

Hi, Betty and team. Thank you for taking the question. Just a quick housekeeping question. At one point, you discussed having an R&D Day during the fourth quarter. I'm just curious if that is still on the calendar. And then you also discussed additional monotherapy data for the IL-27 program.

Is that happening this year? And then more generally, with regards to liver cancer, obviously, there was data from Roche early in the year, and then more recently, the Beijing abstracts related to the TIGIT in combo with atezo and bev.

I'm just wondering how you're thinking about developing for HCC given those data points for the combo for your TIGIT and IL-27..

Thanks for your questions. With respect to R&D Day, given the delay in the approval of on body, we're going to move that into Q1 from Q4. We want to have on-body approved and ready to go on the market because that's going to be an important part of the story. So we're going to move that out into Q1. With respect to IL-27 and liver, I'll let Dr.

LaVallee answer those two questions..

Thanks. We're super excited about the clinical development plan. And in terms of presentations, we do have abstracts submitted on both the monotherapy and the HCC data to give the full data set and a more mature data set. So I would anticipate that later this year and early next year.

And once the abstracts are accepted, we'll make sure to publicize that. In terms of how it's positioned, we're very excited about the data to date and having a patient population more similar to the atezo-bev TIGIT HCC data than the Beijing program, and think that the data should be comparable within that round..

Okay. And then just one on the guidance. McDavid, I think you said for 4Q '23, $85 million to $95 million.

Any way you could just elaborate a little bit more in terms of the relative contribution from the three marketed products as to how that will get you into that range?.

Sure. So earlier in the year, Denny provided insight into how we feel that the adalimumab market is shaping up and that we expect total YUSIMRY sales for the year in the single digits. And so that's important to note as you think about where the portfolio guidance would go for the fourth quarter.

So we expect most of the revenue growth in the fourth quarter to come from UDENYCA and CIMERLI..

Thank you. Our next question comes from the line of Michael Nedelcovych with TD Cowen. Your line is now open..

Thank you for the questions. I have two. My first is, given the shift in timing of revenues and the lowering of your top line guidance, has that impacted your development plans at all? I know we'll learn more on the Q1 pipeline day call.

But I'm curious if this has affected the scope of development for your pipeline portfolio as of where we stand right now? Or for example, would you perhaps replace anticipated revenues with other types of financing to more fully develop your pipeline? And then my second question relates to YUSIMRY.

I'm curious if you attribute ABVI's ability to hold on to such high share for so long, would you point to supply, the label, or perhaps price? Thank you..

Thank you for the question, Michael.

First of all, with respect to the development plan, as I indicated in my opening remarks, we are significantly constraining all R&D expenses from -- to the middle of 2024 because of the revenue picture, we are very, very cognizant that we need to bring our R&D expenses and our overall spend into alignment with our revenue.

And so we have made very, very deliberate efforts to revise our development spend and minimize it, and I would say, into mid to next year. And no, we won't be going to alternative forms of financing to support that.

We think that's really very, very important to move the company back to cash flow positivity and profitability, right? And so that's something we'll have to do till we get greater movement on the revenue. With respect to our YUSIMRY, Humira has been able to hold on to a significant portion of the revenues there. I believe about 99%.

Paul might have a little further color for you on the Humira and YUSIMRY revenue picture as a function of the placement on the formularies and so on.

Paul?.

Yes. Thanks for your question, Michael. I think based on what AbbVie reported that it was really a lower price that's driving their ability to maintain these formulary positions. So that's what's driving it. And again, I reiterate our strategy was very different.

We intended to bring YUSIMRY to market for a segment of the business that desires a low, affordable, transparent price. And we're going to build that business from the bottom up, and that's working and our partners with Mark Cuban are really helping with that. So it's two different strategies.

We're approaching this strategy, setting ourselves up for then the IRA in 2025, when we believe there will be a lot of different considerations by the PBMs and the payers when the cost shifts during the catastrophic phase from the government to the payers themselves..

Michael, the other point that I would make to you is I would just direct you to McDavid Stilwell's comments. While we reduced the guidance -- the revenue guidance for $15 million for 2023, we also reduced the spend guidance by $15 million.

And I think this illustrates that we've been very, very responsible with respect to revenues and expenses are coming into alignment..

Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open..

Hi, good morning. Thanks for taking the questions. So I guess, Paul, congrats on the progress that we've seen with CIMERLI. I'm sorry, having a little cough.

When we think about the trends into the fourth quarter, should we expect to see some further acceleration? Or do you think that we'll see sort of a little bit more of a linear trend in terms of adoption now that we have the J-code and -- you've had the J-code in place for some time?.

Yes. Thanks, Doug. Yes, we're really pleased with the update. I think looking at the ramp, projecting the same level of growth quarter-over-quarter is probably too optimistic at this point. We're going to continue to see demand growth driven from the current book of business and the patients coming back in, but also new business that we get in.

So we -- again, we haven't guided to what the final CIMERLI number is, but we still maintain guides that sales are going to exceed $100 million for the year..

And Paul, do you think the opportunity just improving your volume within your existing CIMERLI accounts? Or are you still picking up new accounts?.

Yes, Doug. In the third quarter, we increased the number of ordering accounts by 70%. So we've got about 550 accounts now that have ordered CIMERLI, 80% have ordered -- reordered at least one time. So it's really this breadth and depth.

We want to go deeper into the accounts that are ordering, convert that still consensus unit volume that's available for Avastin where they've completed their step edits. And at the same time, that continue to broaden out for those accounts that maybe have been a little bit slower on the CIMERLI adoption with biosimilars.

What's really pushing that new account acceleration though, Doug, is the fact that we've got now the Q-code well-established and also real-world evidence that was just presented at the ASRS meeting, demonstrating that CIMERLI is safe and effective and delivering on their clinical profile for Lucentis. We just hit 139,000 units shipped.

Now I know we've press released in the third quarter, it was 100,000, but it's now 139,000. So we're going to bring along those that were a little bit slower on the biosimilar adoption curve..

And final question, Paul, on CIMERLI, is there a type of account that you're really doing well in? Is it the private equity-backed practices? Or is it smaller practices? Just any color would be interesting to hear..

It's been a mix of everything, Doug. It's really just been -- once the retinal specialists understands that biosimilar to Lucentis is a great option for them, they get on board, they trial it, they get reimbursed and we start to see more rapid adoption there. So it's really across the board..

Thank you. Our next question comes from the line of Chris Schott with JPMorgan. Your line is now open..

Great. Thanks so much. Just two questions for me. I guess first, just coming back to the biosimilar Humira market.

Can you just maybe just elaborate a little bit more on the priorities for YUSIMRY as we head into 2024, given it sounds like '25 is really the key year for the market opening up? And maybe just as part of that, I know you did a couple of million this quarter in sales. It sounds like not a huge step up in 4Q.

But should we think about a meaningful step-up of sales in this product in 2024? Or does this remain a relatively small business until we get out to '25 and more the volume comes through? And I just had one follow-up after that..

Thanks for the question, Chris. The issue with the Humira biosimilar market is really the position of Humira on the formularies. And we don't see significant growth in this market until 2025, until the Inflation Reduction Act comes in the pipe and then sort of the pricing dynamics of flip a bit.

So we're projecting shallow but steady growth throughout that time, but with the inflection in '25..

Okay. Okay. That's helpful.

And then just on UDENYCA, just any color of how much of the sales at this point is coming from the auto injector from -- versus the traditional presentation? As I just think about that auto-injector piece of it, do you expect any sort of inflection as I guess just the ecosystem gets more educated on the product or is coverage really the key here? And I know you've talked about some progress on that front.

I'm just trying to get a sense of what the key factors that might lead to that auto-injector seeing broader uptake would be..

Yes. Thanks, Chris. So in the third quarter, the prefilled syringe represented the vast majority of the UDENYCA volume, and it was coming from all segments of the business. So when we launched the auto-injector in the quarter, it was really the first of its kind, a new innovation that the marketplace had never implemented into the system.

So we had to get payer coverage set up. At the same time, we then had to educate the providers and particularly the nurses and the pharmacists, get it on the formularies the order set. So there's a lot of operational work that had to get done to get this set up. We've had about 300 accounts order auto-injectors since it's been approved.

So they're looking for the places where it can fit in the system. We expect that as the launch progresses, we're going to see continued demand increases, and that will be buoyed as we move into 2024 as payer coverage continues to expand.

So once we then have the on body, we'll then be the only brand, Chris, with all three presentations, being a total solution, meeting the needs of the patients and the providers. So I think we got two shots on goal then with the auto-injector and the OBI to go after that Onpro market, which has remained fairly resilient at 42% share..

Our next question comes from the line of Ash Verma with UBS..

I have two. So the first one, I believe you have a milestone payment due to Junshi for the NPC approval. Can you remind us what's the time line and the amount for that? And then second, I thought there was an 8-K filed earlier that noted a smaller lease space going forward.

Is there a new reduced workforce as a part of this? Just surprised to see the space is now cut into half.

And any implications that you can mention for that to your cash burn?.

Ash, thanks for the questions. Let me take the last one first. We were able to reduce the footprint on the lease. Primarily, that came up because we were in a period where there was a renewal period. So we had -- we were opportunistic and being able to do some consolidation. We have team members that work from home and then go back and forth.

So we've done some sequencing with people in and out of the office. We're able to consolidate some space. And as I indicated in my remarks before, we're always looking for opportunities to reduce our expenses, and this is one where we could do so. With respect to the milestone and its timing from Junshi, I'll let McDavid Stilwell comment on that..

Yes. Thanks, Ash. So it's a $25 million milestone payment, and it will be paid in March 2024..

Our next question comes from the line of Balaji Prasad with Barclays..

Good afternoon. This is [indiscernible] on for Balaji. Our question is about partnership opportunity for Toripalimab. You mentioned that you received a lot of partnership interest from outside partners.

Could you add some color on what therapeutic areas or what type of agents that will be prioritized for future combo trials? And what type of collaboration and economy will you adopt for those partnership agreements for combo trials in order to achieve lower R&D cost next year?.

Thank you. Great question. I'll let Rosh Dias, our Chief Medical Officer, address that.

Rosh?.

Thanks very much for the question. So I think as we look at the partnership space, I think the first thing I'll say is that the wealth of data and the robustness of the data for LOQTORZI across different tumor types and indications really sets us up well for partnerships together with its pretty unique mechanism of action as well.

I think for LOQTORZI, the partnership opportunities and incomings that we're receiving are essentially and mainly in terms of novel combinations and the kind of avenue that we're taking with that will be more in terms of drug supply agreements and supplying drug for partnership studies.

We also, of course, have our novel assets that came in with the Surface acquisition of casdozo and CHS-114. And I think one of the important points I'd like to stress there is we do have global rights. So we'll be looking for potential opportunities for these two novel assets to maybe ex U.S. find partnership opportunities for potential revenue there..

Our last question comes from the line of Douglas Tsao with H.C. Wainwright..

I just wanted to just touch on UDENYCA a little. And I'm just curious from your perspective on the broader environment within the pegfilgrastim category as a whole, where we've seen you really have successful maintaining share or gaining some share whilst maintaining your ASP and others have continued to see the ASP fall.

So what do you think has been the sort of the driver of your success and your perspectives on what the next step is for this market?.

I'll let Paul dive in a bit for you, Doug. But I think that we bring at the core competency on the commercial team, a very deep and nuanced understanding of the Medicare Part B space. As you know, our policy for a long time has been the good guardians of ASP and not to rely simply on discounting to drive sales.

The other issue, I think, here is that we have deployed very successfully a strategy to maintain price and share for the long term as a basis upon which to launch our presentation. And we are now successfully deploying that strategy.

Our average selling price is well above the other competitors in the class, significantly above the [ leader ], for example. But I think that we are very confident in terms of our ability to understand price and really to execute our value proposition strategy without simply resorting to price in the market.

I don't know if Paul has some additional comments..

No, I think that's exactly right, Denny. Doug, if you look at what the competitor strategies have been and we've always viewed UDENYCA as a franchise. And so we applied the strategies that we needed to do in order to maximize the long-term revenue, but also profitability of the brand.

What we've seen with other competitors, biosimilars in particular, it just had a prefilled syringe, is to just use deep discounting for short-term market share gains. And you've seen examples of what happens to that strategy. So we really have just taken a long-term view. We've been disciplined with it.

We're bringing the new presentations to market, and we're going to position UDENYCA as the person-only franchise with representation offerings because these patients still need a pegfilgrastim support.

And whether they're getting it in the office, whether they're getting it at home, we're going to have a solution for the patient and the provider to meet those needs. So it really comes down that. And we're delighted that our strategy is paying off, and that you're seeing it now in consecutive quarters..

The other point that I would make, Doug, is we've successfully deployed our Medicare Part B competency from oncology to ophthalmology, where we also were in a position where we launched behind a very, very large competitor by a few months. And then we're very successful in the first year of the market.

I think we're in excess of 25% market share now with CIMERLI in the ophthalmology market. And as you may recall, we are in excess of 20% in the first year of UDENYCA, having launched behind a very large competitor at that point also. I think this proficiency has been demonstrated twice..

Thank you. I would now like to turn the conference back over to Denny Lanfear for closing remarks..

Thank you all for joining us today on our Q3 2023 update, and we'll see you at upcoming conferences, including the Truist conference and the UBS conference this week. Thank you, operator..

Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect..