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spk05: Good day, and thank you for standing by. Welcome to the Cohere's Biosciences third quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. 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.
spk11: Good afternoon, everyone, and thank you for joining us. I am Jamie Taylor, Coherence'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 Coherence Biosciences website. and is also attached to the Form 8K that we filed with the FCC today. Today's call includes forward-looking statements regarding Cochiris' 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 a new product, our expectations for market opportunity, and the timing of our return to being 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 Jenny Lampier, CEO of Coheris, Dr. Theresa Lavallee, Chief Development Officer, Dr. Rosh Daya, Chief Medical Officer, Paul Reeder, Chief Commercial Officer, and McDavid Stilwell, Chief Financial Officer. I'll now turn the call over to Demi.
spk04: Thank you, Jamie, and welcome to the team. Thank you all for joining us today on our Q3 2023 earnings call. We continue to make good progress on our overarching strategy. Lactorsine, our PD-1 inhibitor, is now approved. 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 Q-code, continues to gain share in sales, and our Udenica franchise has returned to growth. However, even as we progress on the overarching strategy, we are cognizant that our revenues and our expenses must come into alignment. Progress has been made here 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 Lactorsi 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 seek profitability. While we plan to enter into partnerships with other companies interested in combining their novel assets with Lactorsi or our TME assets, we do not foresee sharing clinical development costs, which would increase our R&D expenses. So even as revenues increase from the growing number of commercial products, across the board, we'll see opportunities to constrain and reduce expenses as we pursue profitability. With that, I'll hand the call over to Paul Reeder, our Chief Commercial Officer. Paul. Thanks, Denny, and good afternoon, everyone. As a commercial organization, we remain in launch mode with Simmerly, Udenica Auto Injector, and USIMRI, and are prepared to launch two new products in the first quarter next year, Octorzi, which was approved last month, and the Udenica on-body injector following FDA potential approval. This will bring our total number of marketed assets from one to six over an 18-month time period and will drive top-line revenue growth over the coming years. For the third quarter, combined net product revenue was $74.4 million, an increase of 27% over Q2. I'll now speak to each brand, and we'll start with similarly, or biosimilar to Lucentis. Our strategic approach to the retina market is 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. Similarly, market share within the Ranavizumab class was 28.6%, an increase of 11.6 market share points quarter-over-quarter. We also announced it similarly passed a major milestone, where in the first year of launch, we sold over 100,000 doses to retinal specialists, which reinforces the retinal community's receptivity of biosimilars a desire for a safe and effective similar option to lucentis summary total 2023 net sales for similarly through q3 are 73 million so we refer guidance that similarly net sales will exceed 100 million for 2023. now on to you danica stated previously our strategy has been to fortify our base pre-filled syringe business while making price and 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 Udenica demanded 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 Udenica revenue and market share growth. In 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 pre-filled syringe presentation and occurred across all segments of the business. Also in the quarter, we launched the innovative Udenica auto-injector and are working with accounts on how to best position and operationalize the auto injector within their respective clinical process throws. Since commercial launch, we've had over 300 accounts for the Udenica auto injector and are seeing a consistent flow of new account ordering every week. We expect increases in Udenica auto injector demand as the launch progresses. Another positive development that occurred in the quarter is payer coverage. which significantly increased as both Udenica pre-filled syringe and auto-injector presentations were newly added onto a number of commercial and Medicare Advantage plans. Effective start dates of this expanded coverage varied and ranged from September 2023 to January 2024. But regardless of the start date, these contracts extend through calendar year 2024, significantly expanding Udenica's access going into next year. Regarding our novel, Udenica On-Body Device, we are awaiting FDA approval and will launch directly thereafter. Udenica is now a franchise, and following the anticipated approval, Udenica On-Body Injector will be the only Pegfield Graston brand the three presentations offers, becoming the total solution for oncology providers. This will enable us to compete directly with the Blast On program which retains 42% of the market. Turning now to USMRI, or biosimilar to Humira. The high cost of adalimumab treatment remains a problem for the healthcare system and for many patients. Our patient-centric strategy is to provide USMRI at a single, transparent, low price. We launched USMRI on July 3rd, and we're the innovators of the 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 with Mark Cuban Cost Plus Drugs Company and through its Team Cuban card at 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 Yosemite business from the bottom up. In Q3, we sold 2,300 cartons of Yosemite, 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 adalimab 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 how plans consider their formulary selections. Finally, let me reiterate our excitement about the approval and coming launch of Lactorsy, the first and only FDA-approved treatment for patients diagnosed with relapsed or metastatic MPC. We've commenced launch activities and are working to ensure that patients and providers have access to Loctorsi as soon as product is in the channel, which we estimate to be in the early Q1 timeframe. Let me share with you now some more details about the MPC market opportunity for Loctorsi. First, the MPC market. We estimate that approximately 2,000 relapsed metastatic MPC patients in the U.S. are diagnosed each year. And the split is even between those in first line versus second line plus. With Lactorsi'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, approximately 2,200 oncologists, accounting for 80% of NPC treatment. 60% of the business is in the hospital setting, 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 Udenica. Third, the current treatment landscape for NPC. Claims data suggest that chemo-only regimens are prescribed 60% of the time, which provides an immediate opportunity for lactorsis. will target these treating physicians and position Lactorsi 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, we'll position Lactorsi 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 will appropriately communicate branded information about Lactorsi so they are informed and educated when speaking with their doctors about their individual treatment plans. Patients will also be supported through Lactorsi Solutions, our patient services hub, that can be accessed via Lactorsi.com. These are planned to go live next week. We look forward to updating you on our progress as the Lactorsi launch progresses. With that, I'll now hand it over to Teresa.
spk12: Thank you, Paul, and good afternoon, everyone. I want to once again thank the FDA for acting so quickly to approve Lactorsi following completion of the overseas inspection. With Torapalamab approval now secured, We are continuing to collaborate with the FDA to complete their review of our final outstanding BLA for the Eugenica on-body injector. As previously disclosed, the Eugenica OBI supplement received a complete response letter from FDA on September 21, 2023, solely due to a third-party filler'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 Eugenica 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 the early part of 2024 and anxiously await the resource-constrained FDA to take action. Based on PSUFA, the review would be given a six-month clock. However, the agency has communicated to us that they expect to act significantly sooner. I will now briefly review the data from toropalimab and our other IO candidates we recently presented at ESMO and FITC. Lactorsi 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. Coherence has presented our preclinical mechanism of action studies at the ACR-ERTC-NCI triple meeting and last week at the CISI conference comparing toropalimab to pembrolizumab. It demonstrated in multiple assays that toropalimab treatment resulted in statistically significantly higher T cell activations than pembrolizumab. Toropalamab'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 Toropalamab at the FG loop of the PD-1 may also contribute to its higher potency. Lactorsi 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. At the CITC conference last week, we also presented two additional posters characterizing the mechanism of action of Cas-Dosa-Ketab, our IL-27 antibody, and of CHS-114, our cytolytic anti-CPR-8 antibody. The CASDOSO poster highlighted the interferon signaling-like properties of IL-27 and importantly described biomarkers that may be useful for evaluating cancer patient treatment with CASDOSO. The CHS114 studies support that preclinical treatment with an anti-CCR8 antibody leads 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 Lactorsi. Our third program targeting immune-suppressive mechanisms in the tumor microenvironment is our CHS1000 anti-ILP4 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 to Raj.
spk10: Thank you, Teresa, and good afternoon, everyone. With the approval of LOCTOR-Z, we're delighted to be able to bring the first and only FDA-approved treatment for nasopharyngeal carcinoma to patients in the U.S. living with NPC across all lines of therapy. The approval in both first-line patients with a metastatic or recurrent locally advanced disease in combination with splatin and gemcitabine, and also as a single agent for patients with recurrent unrespectable treatment for these patients, where up until now, the standard of care has generally been decades-old chemotherapies. As a reminder, the approval is based on strong efficacy data from two well-conducted studies, the data published in Nature Medicine and JCO, and presented at both AACR and ASCO. Firstly, in Jupiter 2, Lactose in combination with chemotherapy in first-line patients showed a hazard ratio of 0.52 for progression-free survival. and 0.63 for overall survival, with benefits seen across all PD-L1 expression levels, with the results being both statistically significant as well as clinically meaningful. Secondly, in Polaris 2, in Second Line and beyond, single-agent Loptozzi met its primary endpoint with an overall response rate of 20.5% and also demonstrated a median overall survival of 17.4 months. The adverse event profile in both trials demonstrated the drug class. Positive data sets across additional tumor sites continue to demonstrate the consistency of effect of LactoZ. For example, at ASCO, the NeoTorch data in the perioperative non-small cell lung cancer space showed a statistically significant benefit favoring the toripalamab arm with a hazard ratio of 0.4 for event-free survival, demonstrating the potential of toripalamab in earlier stage non-small cell lung cancer. We're working with the FDA to explore potential avenues to bridge the data to the US. Also, at ESMO a few weeks ago, positive data was reported for Loptozzi in both renal cell carcinoma as well as small cell lung cancer. The additional rich data sets that have continued to emerge as well as external partnerships for Loctosi. Key to this is our acquisition of surface oncology, which, as Teresa mentioned, has provided us with two early-stage assets, CasDozo, first-in-class and only clinical stage IL-27, and CHS114, our CCRA. Firstly, with respect to CasDozo, as a reminder, this asset has shown monotherapy activity in Phase I studies 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 forwards with a phase 1B combination study of Casdoza with toripalamab, which is currently in startup and which we anticipate being active in the coming months. With respect to CHS114, 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 escalation 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 1-2A study looking at the toropalamab-TIGIT combination 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 competitive trials in order to be able to complete a robust portfolio prioritization, whilst at the same time continuing our clinical development efforts with Loctosi in combination with Casdozo and CHS114, together with continued development of our ILT but also the tumor microenvironment in a potentially synergistic fashion. I'll now turn the call over to Mr. David. Thank you, Raj.
spk04: 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 30th, 2023, and included $33 million of net sales of Eugenica, $40 million of net sales of Simmerly, $1.4 million of USIMRI net sales, as well as approximately $200,000 in royalties we received from a license to our AnalymaMath formulation. Cost of goods sold for the three months ended September 30th, 2023, was $32.7 million, and gross margin was 56%. Recall that Udenica COGS includes a mid-single-digit royalty on net sales payable through the first half of 2024, and similarly 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 into September 30th, 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 Toro Palomar Collaboration Agreement, the capitalization of certain Yosemite costs in the 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 continue to realize savings from the cost-cutting program 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 Yosemite strategy is to build a business with customers attracted to our lowest price at a limit map offering. and we have very low operating expenses associated with UCIMRI. Toripalamab will be efficiently launched using the same commercial infrastructure of marketing, Utenica. 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, $39.6 million, or 41 cents 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. expect fourth quarter net sales of 85 to 95 million dollars for the full year 2023 we are reducing our earlier revenue guidance to a range of 250 to 260 million dollars primarily as a result of the delay in approval of eugenica 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 to $335 million to a new range of $300 to $310 million, including $40 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 collaborations. or the closing costs 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 Coheris back to being cash flow positive over the course of 2024. I'll now hand the call to Jenny for closing remarks prior to questions. Thank you, McDavid. Coheris is now one of a 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 a revenue-generating immuno-oncology company with growing sales across a number of products. We have an increasingly diversified revenue base. We look forward to keeping you apprised of our progress. Operator, we're ready for the questions.
spk05: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Robin Kronoskis with Truist Securities. Your line is now open.
spk06: Hi, guys. Thanks for taking my question. I mean, given the stock reaction, I think people are focused on consensus. So I have two questions for you on that. For Adenica, scripts were up, actually, and then you noted on the prepared remarks you took, you know, I think pricing concessions. Can you help us understand some of the dynamics going on with Adenica? On similarly, it seems like on the Regeneron call, like where are you taking share? It doesn't 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 to like being cash so positive next year, which is like a big thing for you. Is that still on track or do you want to withhold that guidance? Thank you.
spk04: Hi, Robin. Thanks very much. So your first question with respect to Udenica is it describes that, but what was the impact of pricing? And then with respect to similarly, you know, where is the share coming from? And lastly, the guidance. I'll let Paul first address the dynamics of the Udenica market and address the question of where the similarly share came from. Paul. Thanks, Danny. Thanks for your question, Robin. Yeah, the Udenica business, Robin, as we... 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. It'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 competitive markets. In the third quarter, we saw a net selling price decline of about 9%. So that's the puts and take. 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 pair 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 on-pro share, which is at 42%. Regarding similarly, 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. Can I ask one more question? Yes, I would like to answer 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've We've 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, essentially, of OnBody and of LaTorze, we'll be happy to revisit that for you. 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.
spk06: Super helpful. And just a follow-up on Odenica. 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 Teresa like last like last call you did again congrats Victoria I'm not asking one on Victoria but congrats but maybe just like you maybe delve deeper into identica so that we can all model it better next quarter and for next year yeah thanks Robin so you know the our our focus here is we're going to be going into 2024 and year six of the identica you know life cycle is
spk04: 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. Robin, I would also add that we expect a significant market share gain with Eugenica next year, and we're very cognizant of the margins in obtaining those gains. As you've seen, the payer coverage has significantly increased over the past quarter. We expect to see that next year. But the overarching message for the Udenica franchise is that the long-term strategy is succeeding. As Paul indicated, we're in year 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 price have now fallen away, we are emerging in this market.
spk06: Do you think you could 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?
spk04: We would seek to protect price even as we go forward having all three presentations.
spk06: Great. Thanks so much. Congrats, guys. Thank you.
spk05: And gals. Thank you. Our next question comes from the line of with Citigroup. Your line is now open.
spk07: Hi, Betty and team. Thank you for taking the question. Just a quick housekeeping question. At one point you had 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 earlier in the year and then more recently the Beijing abstracts related to the TIGIT in combo with the TEZO 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.
spk04: Hi, thanks for your questions. With respect to R&D Day, given the delay in the approval of OnBody, we're going to move that into Q1 from Q4. We want to have OnBody 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. LaValle answer those two questions.
spk12: Hi, Dougie. Thanks. and we're super excited about the clinical development plans and in terms of presentations we do have abstracts submitted on both the monotherapy and the hcc data and to give the full data set and a more mature data set so we'd anticipate that um 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, having a patient population more similar to the ATHESO-BEV-TIGID HCC data than the Beijing program, and think that the data should be comparable within that realm.
spk07: Okay, thanks. And then just one on the guidance, McDavid, I think you said for 4Q23, 85 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? Thank you.
spk04: Sure. So earlier in the year, Denny provided insight into how we feel that the Adam and Matt market is shaping up and that we expect total Yosemite 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 Udenica and similarly.
spk07: Got it. Okay. Appreciate it. Thank you.
spk05: Thank you. Our next question comes from the line of Michael Nedelkovich with TD Cowan. Your line is now open.
spk08: 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 USMRI. I'm curious if you attribute AbbVie's ability to hold on to such high share for so long Would you point to supply, the label, or perhaps price? Thank you.
spk04: Thank you. Thank you for the question, Michael. First of all, with respect to the development plans, 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, 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 to cash flow positivity and profitability, right? And so that's something we'll have to do until we get greater movement on the revenue. With respect to USMRI, Humira has been able to hold on to a significant portion of the revenues there. I believe about 99% all might have a little further color for you on the Humira and USMRI revenue picture as a function of the placement on the formulary and so on. Thanks for your question, Michael. I think, you know, based on what Abby reported, that it was really the lower price that's driving their ability to maintain these formulary positions. So that's what's driving it. And again, I reiterate, you know, our strategy was very different. We intended to bring Yosemite to market for a segment of the business. desires of low affordable transparent price and um and we're going to build that business from the bottom up and uh and that's working our partners with mark human are um are really helping with that so so it's two different strategies we're approaching this strategy setting ourselves up for then uh the the ira in 2025 when we believe there'll be a lot different considerations by the 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 David Stilwell's comments. While we reduced the revenue guidance for $15 million for 2023, we also reduced the spend guidance by $15 million. And I think this illustrates that being very, very responsible with respect to revenues and expenses coming into alignment. I understand. Thanks for the question.
spk05: Thank you. Our next question comes from the line of Douglas Sal with HC Wainwright. Your line is now open.
spk02: Hi, good morning. Thanks for taking the question. So I guess Paul, congrats on the progress that we've seen with Simerly. Sorry, I'm 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 know, you've had the J-code in place for some time?
spk04: Yeah, thanks, Doug. Yeah, we're real pleased with the update. You know, I think looking at the, you know, the ramp, projecting the same level of growth quarter over quarter, probably too optimistic at this point. We're going to continue to see, you know, demand growth driven from the current book of business and the patients coming back in, but also, you know, new business that we get in. Again, we haven't guided as to what the final similarly number is, but we still maintain guides that sales are going to exceed $100 million for the year.
spk02: And, Paul, do you think the opportunity just improving your volume within your existing similarly accounts, or are you still picking up new accounts?
spk04: Yeah, 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 similarly. 80% have 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, grab Avastin, where they've completed their step edits and at the same time then continue to broaden out for those you know those accounts that maybe have been a little bit slower on the on the similarly adoption with biosimilars which really pushing that new account acceleration though doug is the fact that you know we've got now the q code well established but also real world evidence you know that was just presented at the asrs meeting uh demonstrating that similarly is safe and effective and delivering on their clinical profile for Lucentis. We just hit 139,000 unit shift now. I know we pressed released in the third quarter. It was 100, 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.
spk02: And final question, Paul, on Simerly. 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. Thanks.
spk04: It's been a mix of everything, Doug. You know, it's really just been once a retinal specialist, you know, understands a bio similar to Lucentis, you know, is a great option for them. They get on board. They trial it. They get reimbursed. And we start to see, you know, more rapid adoption there. So it's really across the board.
spk02: Okay, great. Thank you. I'll hop out of the queue.
spk05: Thank you. Our next question comes from the line of Chris Schott with J.P. Morgan. Your line is now open.
spk03: Great. Thanks so much. Just two questions for me. I guess first we're just coming back to the biosimilar Humira market. Can you maybe just elaborate a little bit more on the priorities for UCMRI as we head into 2024, given it sounds like 2025 is really the key year for the market opening up? And maybe just as part of that, I know you did a couple million this quarter in sales. 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 of the volume comes through? And I said one follow-up after that.
spk04: All right. Thanks for the question, Chris. The issue with the Humira Biosimilar market is really the – 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 into play, and then sort of the pricing dynamics flip a bit. So we're projecting shallow but steady growth, you know, throughout that time, but with the inflection in 2025. Okay. Okay.
spk03: That's helpful. And then just on Udenica, just any color of how much of the sales at this point is coming from the auto-injector versus the traditional presentation? And 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.
spk04: Yeah, thanks, Chris. So in the third quarter, the pre-filled syringe represented the vast majority of the Udenica 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. the same time we then had to educate you know the providers and particularly the nurses and the pharmacists hit it on the formularies the order set so there's a lot of operational work that had to get done to you know to get this set up we've had about 300 accounts order auto injectors since it's been approved so they're looking for you know the places where it can fit in the system we expect that as the As the launch progresses, we're going to see continued demand increases, and that will, you know, be buoyed as we move into 2024 as payer coverage continues to expand. So, you know, once we then have the on-body, we'll then be the only brand, you know, Chris, with all three presentations, you know, being a total solution, meeting the needs of the patients and the providers. So, we've got two shots on goal then with the auto-injector and the OVI. to go after that on pro market, which has been made fairly resilient at 42% share.
spk00: Great. Thanks so much.
spk05: Thank you. Our next question comes from the line of Ash Verma with UBS. Your line is now open.
spk01: Hey, guys. Thanks for taking my question. 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 timeline and the amount for that? And then second, I saw there was an 8K file earlier that noted a smaller lead 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 flow. Thanks.
spk04: Hi, Yesh. Thanks for the question. 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 were opportunistic in 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, you know, as I indicated in my remarks before, we're always looking for opportunities to reduce our expenses, and this is one, you know, where we could do so. With respect to the milestone and its timing for Junshi, I'll let McDavid Stilwell comment on that. Yeah, thanks, Ash. So it's a $25 million milestone payment, and it will be paid in March 2024. Great.
spk05: Thanks. Thank you. Our next question comes from the line of Balaji Prasad with Barclays. Your line is now open.
spk09: Good afternoon. This is Xiao Ang for Balaji. Thanks for taking our question. Our question is about partnership opportunity for Tori Palamab. 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 you 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 costs next year? Thank you.
spk04: Thank you. Great question.
spk10: I'll let Raj to ask our Chief Medical Officer Thanks very much for the question. So I think, you know, 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 Loctosi 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 Loctosi, 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, so Casdoso and CHS114. And I think one of the important points I'd like to stress today is we do have global rights, so we'll be looking for potential opportunities with these two novel assets to maybe ex-U.S. find partnership opportunities for potential revenue there.
spk00: Thank you.
spk05: Thank you. We have time for one last question. Our last question comes from the line of Douglas Sao with H.C. Wainwright. Your line is now open.
spk02: Hi, thanks for taking the follow-up. I just wanted to touch on Udenica a little. And I'm just curious from your perspective on the broader environment within the pixel graphs and category as a whole where we've seen you really have successful maintaining shares, maintaining some share while maintaining your AST and others have continued to see the AST 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. Thanks.
spk04: I'll let Paul dive into that a bit for you, Doug. But I think that we bring, as a 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 been the good guardians of ASP and not to rely simply on just counting 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 the 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 innovator, for example. But I think that we're very competent in terms of our ability to understand price and really to execute our value proposition strategy without simply resorting to price in the market. Paul has some additional comments. I think that's exactly right, Denny. Doug, you look at what the competitor strategies have been, and we've always viewed Udenica 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, Similars in particular, they just had a pre-filled syringe. is to just use deep discounting for short-term market share gains. And, you know, you've seen examples of what happens to that strategy. So we really have just taken the long-term view. We've been disciplined with it. We're bringing the new presentations to market. And we're going to position, you know, Udenica, you know, as the first and only franchise with three presentation offerings because these patients still need them. We still need Pegfield Graston 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 to 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, you know, 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 similarly in the ophthalmology market. And as you may recall, we are in excess of 20% in the first year of Eugenica, having launched behind a very large competitor at that point also. I think this proficiency, has been demonstrated twice.
spk10: Okay, great. Thank you so much, and that's really helpful.
spk02: Thank you, Daryl.
spk05: Thank you. I would now like to turn the conference back over to Denny Lanphier for closing remarks.
spk04: Thank you all for joining us today on our Q3 2023 update. We'll see you at upcoming conferences, including the Truist Conference and the UPS Conference this week. Thank you, operator.
spk05: Thank you. This concludes today's conference call. Thank you for your participation. You may now
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