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Ladies and gentlemen, thank you for standing by, and welcome to the Q2 2022 Coherus BioSciences, Inc. Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Marek. Please go ahead.

Thank you, Mandeep. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our financial results for the second quarter of 2022. This release can be found on the Coherus BioSciences website and is also attached to our Form 8-K. 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 launch multiple new products, our ability to generate sufficient sales to achieve revenue growth and profitability, our SG&A and R&D expense guidance, our projected market share, our 2026 top line projections, our projections about market opportunities and our ability to advance our product candidates and successfully launch our products according to our projected time line. All 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 results, performance or achievements 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, including those in our quarterly report on Form 10-Q for the second quarter that we filed today. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements. With me on today’s call are Denny Lanfear, CEO of Coherus; Paul Reider, Chief Commercial Officer; Dr. Rosh Dias, Chief Medical Officer; and McDavid Stilwell, Chief Financial Officer. Our Chief Development Officer, Dr. Theresa LaVallee, is traveling on vacation and is unable to join us. I will now turn the call over to Denny.

Thank you, Marek, and good afternoon, everyone. Thank you for joining our conference call to review recent business highlights and financial results for Q2 2022. First, let me make a few remarks about progress on our strategy. I’m pleased to report today continued strong execution to transform Coherus into an innovative immuno-oncology company driven by revenues from a diversified portfolio of true products. We’ve entered into an exciting 12-month period, where we expect to launch multiple products, resulting in growing revenues, which will ultimately leads back to profitability. The Coherus team has executed particularly well with respect to CIMERLI, which is now our third approved product. As you know, earlier this week, the FDA approved our Lucentis biosimilar with the interchangeability designation and interchangeability exclusivity for 12 months. The approval also included both Lucentis dosage and strengths and the old Lucentis level. This is important because it means that when we launch later this year, we will do so at the formation of Lucentis biosimilar market with a significantly differentiated biosimilar label relative to other competitors. The one other approved biosimilar has only one improved dosage strength and in complete and limited label and does not have an interchangeability designation. Furthermore, two of the potential competitors recently announced regulatory delays are not expected to launch for a year or more, as Paul Reider, our Chief Commercial Officer, will elaborate for you in just a moment. The CIMERLI commercial opportunity will leverage our demonstrated strength as seen with UDENYCA and buy-and-bill markets. For all these reasons, we believe we will do very well with CIMERLI and that our confidence is justified. Our fourth product candidate, toripalimab, our PD-1 inhibitor is back on track due to the stellar execution by our regulatory affairs, quality and manufacturing teams, working alongside our partner, Junshi Biosciences. Together, we rapidly responded to the issues identified in the FDA’s April 29 complete response letter, which we characterized at the time as straightforward and readily addressable. Having resubmitted the BLA in less than two months’ time indicates both that this was a fair characterization and that our team is highly focused on strong execution across the board. The FDA has assigned a new PDUFA date of December 23, 2022. And we expect to launch toripalimab very early 2023 into nasopharyngeal carcinoma if approved. Our immuno-oncology strategy in the U.S. includes evaluating toripalimab’s ability to deliver substantial clinical benefits and significant indications in combination with other cancer drugs and immunotherapy through co-development treatments or other arrangements designed to drive utilization. Our objective is to establish Coherus as a partner of choice for a company’s seeking PD-1 combinations for their immuno-oncology programs. In a moment, Dr. Rosh Dias, our Chief Medical Officer, will detail multiple internal toripalimab combinations we’re advancing in clinical and preclinical development. While we have entered the product – while we have entered the period of product portfolio growth and top line revenue inflection, we remain tightly focused on our expense structure and are reducing costs whenever possible. Our Chief Financial Officer, Mr. McDavid Stilwell, will provide you some additional color on our financial results in just a moment. With an efficient operational structure in place, $275 million in cash at quarter end and access to an additional $100 million in nondilutive capital post approval of CIMERLI and toripalimab, the company is in a strong financial position going forward into the launches. Those launches and continued strong execution across the company support our 2026 top line projections of $1.2 billion to $2.2 billion provided at our Analyst Day event earlier this year. We reiterate this guidance now. We are well on our way to the product portfolio and revenue diversification [indiscernible] as we have long planned. Well capitalized and with certainly in our direction, we are confident that the multiple anticipated new product launches for the next 12 months will deliver growth consistent with our plans and as I mentioned earlier, ultimately drive us back to profitability. I’ll now turn the call over to Dr. Dias, who will provide you an update on the toripalimab BLA review and our other development programs. Rosh?

Thanks very much, Denny, and good afternoon, everyone. So as Denny referenced the FDA has accepted our resubmitted BLA for toripalimab for nasopharyngeal carcinoma and assigned a new target action date of December 23. If you recall, the CRL we received in late April requests the quality process change that we characterized at the time as straightforward and readily addressable. And we quickly met with the FDA to ensure our understanding of their needs and completed the resubmission in late June. The agency have communicated that the review time line for the BLA resubmission would be six months as, of course, the required on-site inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China. In our conversations with the FDA, they have repeatedly indicated that the existing toripalimab clinical data are supportive of the BLA resubmission given, of course, that toripalimab would address the critical unmet medical need for patients with nasopharyngeal carcinoma, which, as you know, is an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments. So over the next several months, we and Junshi Biosciences will work closely with the FDA to facilitate the review of this novel agent. Toripalimab continues to demonstrate robust clinical data in a variety of immunologically responsive tumors of both monotherapy and also in combination with chemotherapy. And we’re continuing to work with Junshi to prioritize the clinical trial program for multiregional clinical studies while at the same time, also looking at partnership opportunities to advance novel immunotherapy combinations. As we detailed at our Analyst Day event in March, we’re planning to develop the dual I/O treatment of toripalimab in combination with our TIGIT CHS-006 for non-small cell lung cancer, leveraging the robust efficacy results reported in the CHOICE-01 study. Blockade of the TIGIT pathway may be a crucial underlying mechanism for overcoming PD-1 resistance. And we believe that a dual immunotherapy approach of TIGIT with PD-1 to enhance PD-1 efficacy with the potential to extend survival and create a new standard of care for multiple tumor types. With that in mind, an ongoing Phase 1 clinical trial evaluating CHS-006 and toripalimab is currently being conducted in China and is expected to read out next year. And also an IND is currently open in the U.S., and we expect to begin enrolling cohorts of U.S. patients, either later this year or very early next year. In addition, we do expect to see important clinical data in the course of several other competing TIGIT programs over the coming months, and these data may inform the future direction of our CHS-006 development program. We’ve also, this year, introduced several fully owned programs targeting ILT4 and CCR8 that are being developed by Coherus scientists at our research center in Camarillo in Southern California. And we expect to submit an IND for the first of these CHS-1000, targeting ILT4 next year and to file at least one new IND per year going forward. With that, I’ll now turn the call to our Chief Commercial Officer, Paul Reider. Paul?

Thank you, Rosh, and good afternoon, everyone. Before I review the highlights of our product portfolio, I’m pleased to announce that Karen Kotz has joined Coherus as our new Executive Vice President of Sales and Strategic Accounts, following the retirement of Chris Thompson earlier this year. Karen most recently worked in Pfizer Oncology where for the last decade, she has served as a key sales executive and a member of the North America leadership who is responsible for launching over a dozen new oncology therapies and growing the business from under $1 billion to over $6 billion in revenue. Karen is an experienced sales executive with a proven track record of success in both oncology branded and biosimilar product launches. She has an inductee of Pfizer’s exclusive and prestigious Hall of Fame. We are thrilled to have her as our new Head of Sales and leading the multiple product launches planned over the next year. Now let me start with UDENYCA. UDENYCA performance in the second quarter reflects positive execution of our overall strategy of maximizing the long-term revenues of UDENYCA by balancing price share trade-offs in this competitive market. Net sales were $60 million in the second quarter, similar to the prior quarter. Market share was 15%, a 1% decline over the prior quarter with share losses occurring in the low margin 340B Hospital segment. Overall demand units in the second quarter were stabilized and equivalent to Q1, with growth in the clinic offsetting declines in the 340B Hospital segment. Net selling price declined 3%, reflecting continued price erosion due to intense competitive pressures in prefilled syringe margin. On a unit basis, the overall pegfilgrastim market increased 5% over Q1. And we expect low single-digit market growth for the remainder of 2022, which is consistent with historical trends. Neulasta remains and retains 58% total market share within the entire class of the Onpro device owning 46% market share, based on an entrenched preference by customers, which has been reinforced by the COVID pandemic and continued price discounting by the originator. Our on-body injector in the pipeline, our strategy is to maintain a disciplined approach managing price with the prefilled syringe format in 2022. This will enable us to maximize longer-term revenues to the UDENYCA franchise through significant share gains that we expect in 2023 and beyond within the On-Body segment, which currently represents approximately $1 billion in untapped opportunity. We expect UDENYCA market share to grow next year once we introduce our UDENYCA on-body injector if approved. Now I’d like to talk about commercializing our very exciting pipeline. We are preparing for the launch of three new brands in the next 11 months: CIMERLI, our Lucentis biosimilar; toripalimab, our PD-1 inhibitor for NPC; and YUSIMRY, our Humira biosimilar. With respect to CIMERLI, FDA approval was granted on August 2, enabling commercial launch. We have early biosimilar market formation periods of the $7 billion anti-VEGF market. Commercial launch planning is proceeding on track, and we plan to have first sale to occur in early October. We remain highly confident in executing successful launch of CIMERLI based on a number of factors. First, our commercial capabilities. Since our last call, we hired a dedicated retinal sales team, all of whom have years of experience selling to retinal specialists. Our existing key account, care and field reimbursement teams will support the launch, enabling synergies and cost efficiencies. And our launch will be backed by a full-service comprehensive patient support program built to meet the needs of both providers and patients. The second factor is CIMERLI’s clinical profile and differentiated label compared to the other recently launched Lucentis biosimilar. CIMERLI is the first and only biosimilar designated by FDA as fully interchangeable with Lucentis of all five FDA-approved indications. We also received 12 months of interchangeability exclusivity. The head-to-head COLUMBUS-AMD trial was published last year in the peer-reviewed journal Ophthalmology and demonstrated the clinical equivalence of CIMERLI to Lucentis with a comparable safety and immunogenicity profile. These combined will give retinal specialists a high degree of confidence to prescribe CIMERLI for patients currently receiving Lucentis as well as for any newly diagnosed new patients with an indication. And our market research confirms that depending upon access and practice economics, opportunity exists to expand CIMERLI use into Avastin and Eylea. The third factor is our deep understanding of the retinal market and our track record of commercial success. This is a claim-based, buy-and-bill model, which is very similar to oncology and a core competency of ours and backed by our track record of success with UDENYCA, which has delivered $1.3 billion in net sales since its commercial launch in 2019. Today, Coherus is the only company competing in the retinal biosimilar market with the U.S. biosimilar launch experience. In short, retinal specialists and opinion leaders express positive receptivity to Coherus entering this market. And our track record of success in oncology gives them confidence that Coherus understands the dynamics of a buy-and-bill market and that we will deliver a safe and effective alternative to Lucentis with a compelling value proposition. Now regarding toripalimab. Commercial launch plans are now focused toward the FDA action date of December 23. And we are excited about the potential to bring to oncologists and patients what would be, if approved, the first and only PD-1 inhibitor indicated for nasopharyngeal carcinoma and to establish a new standard of care in all lines of therapy, including first-line. NPC is a rare cancer in which high unmet need exists and there are currently no FDA-approved therapies, including checkpoint inhibitors. Our oncology commercial capabilities have been built to scale, and there is significant overlap between our incurring UDENYCA customers and toripalimab-targeted prescribers. Therefore, the launch of toripalimab will be efficiently integrated into our existing oncology commercial infrastructure. In addition, the NCCN Guidelines Committee for NPC has added as a reference to the guidelines the citation for the JUPITER-02 trial, which was published in Nature Medicine last year, further validating the importance and quality of the toripalimab clinical data. Commercial launch preparations remain on track, and the field-facing teams have been fully trained. We will be ready to launch toripalimab if approved by FDA. Now regarding YUSIMRY, a Humira biosimilar. If you recall, YUSIMRY was approved by FDA last December, and we were preparing for launch in July 2023. Humira’s U.S. net sales were $17 billion in 2021, and we look forward to competing in this large market. We believe payers and PBMs will drive biosimilar adalimumab adoption and have completed extensive market research with national and regional payers as well as PBMs. The insights claimed from this market research confirms that Coherus can deliver on the attributes most important to payers, which include a highly competitive price, robust and reliable supply and an auto-injector presentation that has a nonstinging citrate-free formulation. YUSIMRY will have both a prefilled syringe and an auto-injector presentation at launch with our proprietary, nonstinging citrate-free formulation delivered by a 29-gauge needle comparable to the originators. We also plan to introduce a high concentration presentation post launch. To meet our expectations to achieve at least 10% unit market share peak, Coherus has invested more than $45 million in large-scale manufacturing and expects to be a high-volume, low-cost manufacturer, well positioned to compete on supply guarantees and price. Our first-year manufacturing capacity exceeds 1 million units or about 10% of the overall market. And we have the potential to triple that capacity in the current facility. Now unlike some other market participants, we have no portfolio of branded alternatives to Humira that we need to protect from adalimumab cannibalization. Our YUSIMRY strategy is that it’s well aligned in that of the product selection decision makers for the payers and PBMs. We both seek to make the adalimumab biosimilar market as large as possible as quickly as possible. And we see this alignment as a source of competitive advantage. In short, we are confident that we will deliver a compelling value proposition and that we can achieve our objective to win at least 10% unit market share in peak. I’ll now turn the call to McDavid, who will review the quarter’s financial results.

Thank you, Paul. The details of our financial results are in the press release, the 8-K and the 10-Q that we filed this afternoon. So I’ll focus today on just a few highlights. For the second quarter of 2022, we reported a $15.2 million net loss on a GAAP basis or $0.65 per share compared to a net loss of $29.9 million or $0.40 per share in the second quarter of 2021. On a non-GAAP basis, we reported a net loss of $36.3 million or $0.47 per share. The reconciliation from GAAP to non-GAAP in the recent quarter included $13.9 million in noncash stock-based compensation expense and is contained in our press release. Cash used in operating activities was $50 million for the second quarter of 2022. As Paul detailed earlier in the call, UDENYCA net revenues were $16.1 million, on par with the prior quarter an increase in demand units sold in the Clinic segment was partially offset by a lower net realized price. The decline in revenue compared to the $87.6 million we reported in the second quarter of 2021 is due to lower demand as well as lower net realized price. Research and development expense for the three months ended June 30, 2022, was $41.6 million as compared to $54.8 million in the same period in 2021. The decrease was driven by lower development costs and several clinical studies were completed in 2021, partially offset by higher compensation expense. Selling, general and administrative expense for the three months ended June 30, 2022, was $51.3 million compared to $40.3 million for the same period in 2021. The increase was primarily driven by higher commercialization expenses to support current UDENYCA sales and to prepare for multiple anticipated new product launches in 2022 and 2023, including CIMERLI, toripalimab, YUSIMRY and the on-body injector presentation of UDENYCA. We ended the quarter with cash, cash equivalents and investments in marketable securities of $275.5 million compared to a balance of $417.2 million at year-end 2021. With the approval of CIMERLI and subject to certain conditions, we can now request an additional $50 million under our credit facility with Pharmakon advisers. Another $50 million tranche will become available upon the approval of toripalimab. And today, we are reducing our guidance for 2022 combined SG&A and R&D expenses from a range of $395 million to $430 million previously to a range of $375 million to $395 million today. The revised guidance range reflects a reduction in R&D expenses associated with YUSIMRY manufacturing scale-up and auto-injector production, which will now instead be capitalized into inventory in accordance with relevant accounting rules. Our R&D and SG&A expense guidance excludes both the $35 million upfront fee to Junshi Biosciences we paid for rights to CHS-006 and the $25 million milestone payment that will become due upon the approval of toripalimab for NPC. This range also includes approximately $55 million to $60 million in noncash stock-based compensation expense. We have always run Coherus to focus on operating efficiency. And we are continuously reviewing processes, programs, vendors and head count for additional opportunities to reduce costs. As we prepare to launch multiple new products over the next 12 months, we project an inflection in revenues while our operating expenses are expected to rise only modestly in 2023 and 2024. With current cash on hand, additional liquidity that we will request to our credit facility and increasing product revenues, we believe we have the financial strength to execute our new product launches and continue our R&D investments despite turbulent biotech equity markets. I’ll now turn the call back to Denny for closing remarks.

Thank you, McDavid. Coherus is entering a rapid product portfolio expansion as well as revenue growth and diversification. Due to the outstanding execution by our team on plans that we initiated back in 2019. With the approval of CIMERLI, we now have three FDA approved products with four product candidates in the final stage of FDA review, preparing for launch of 4 new products in 2022 and 2023 to generating sales, which will return the company to revenue growth and profitability. With $275 million in cash and cash equivalents, access to additional capital through existing agreements and the significant projected revenue growth, we believe we have the financial resources to launch and support these new products while judiciously continuing to invest in the oncology pipeline opportunities. Operator, we’re ready to take questions.

[Operator Instructions] Our first question comes from the line of Ken Cacciatore from Cowen and Company.

Thanks so much. Denny, with the approval of CIMERLI, it really feels like there’s been a big kind of momentum change, at least it did to me. The shares didn’t react, but you now have what could be a major product in your hand. And when we talk to retinal specialists, they talk about this being a heavily payer-driven market. And I’m not saying anything is easy in life. I know all launches are difficult, but it just strikes us as this should be a little bit even more straightforward than the UDENYCA complexities that you nicely navigated. So maybe a little bit more detail on your ability to win here? Maybe discussion around pricing to win? And then also, just secondly, on Humira, you have the approval early. I can’t think of any reason why kind of the negotiations can’t begin now other than payers and others wanting to see all the products that are available. But can you just talk about kind of the early insight you’ll get into the Humira opportunity maybe well ahead of the actual launch? Thanks so much.

Sure. Well, thank you, Ken, and thank you very much, which I think your observations are right on. This is a road that we’ve been down before, and we did very well on – this will now be the second time. I’ll let Paul Reider, my Chief Commercial Officer, make some divisional remarks. But we consider entering the Lucentis part of the VEGF market, very much ideal. Below in the market, you have, of course, you advance in the reformulation products. Above it, you have Eylea and other products. And we think entering that big center part of the market and expanding in both directions is really a sort of ideal strategy. We’re thrilled actually, though, to get the interchangeability and the exclusivity with the interchangeability and to further, to be the one proven biosimilar team out there at market formation with a very, very strong product. And I’d just add that the reason this product got interchangeability was because of clinical data and the analytical data and having the various doses in a very complete package was compelling to the FDA agent providers with that. I’ll let Paul say additional marks on CIMERLI. With respect to YUSIMRY, the Humira biosimilar and the interactions with the payers and so on. I think that it was very clear to us early on as late as 2 years ago, what would be important to these payers. And that is high capacity, so we invested $45 million in the biggest field tanks, the trade feed formulation. So I wouldn’t say a small needle. Being there at market formation with a significant amount of inventory. We knew what would be important to that. And we went ahead and made those investments do that. So we think we’re going to do quite well when the gun goes off next July. But with that, I’ll let Paul make a few remarks about CIMERLI, some of these insights on that market, team we put on the ground and so on and what we expect. Paul, can you give Ken a little more color?

Yes, sure. Ken, thanks for your question. Your question was sort of focused around the payer segment. And look, we’re battle tested with the payers. We’ve got a dedicated payer team that’s got relationships with all the national, regional plans as well as the PBMs with the approval now, substantial engagement conversations occurring now with them. And I think what retinal specialists want is, they want – they want freedom to be able to make the best clinical choice for the patients. And so that’s really going to be how we’re going to align our overall strategy. As Denny mentioned, we’ve got a differentiated product that’s going to be very compelling. And we’re going to deliver a very compelling value proposition to all stakeholders. So we’re excited to come in here. And we think the interchangeability designation and exclusivity will provide yet another differentiating component as we’re talking with payers because, quite frankly, retinal specialists, they want to stock multiple biosimilar products. And when it comes to the ranibizumab similar product, they’re going to want to use the one that’s got the full label, all the dosage strengths and the interchangeability designation. And that’s where CIMERLI is going to be. So we’re really excited about coming into this market. Now regarding price, we’re going to be talking more about price as we get a little bit closer to commercial launch in the coming weeks. So stay tuned on that.

Ken, I would just offer two follow-ons to Paul’s remarks. The first is with respect to price and this sort of buy-and-bill and ASP-driven environment. I think our experience with UDENYCA has left us fully informed how to manage price in this sort of environment for the long-term, and that’s what we intend to do. One more point about interchangeability. Interchangeability to us means that a physician can be comfortable, transitioning and converting a stable patient to a biosimilar, and that’s a message that we are going to deliver. We don’t have to wait for a fresh start. This product has been deemed interchangeable by FDA. Doctor, you can feel comfortable converting your patients.

Great. Thanks so much.

Our next question comes from Salim Syed from Mizuho. Please go ahead.

This is Bennett for Salim. Thanks for taking our question. If you could please provide some color on the expected timing for getting CIMERLI pre-filled syringe presentation. Do you think that having this presentation would be key to capture significant share given that most are presented for example, sold today in this format? And a really quick one, if you could please remind us if UDENYCA on-body injector application has been submitted or not? Thanks.

All right. Let me take the last question first. Consistent with our prior remarks, we do not intend to disclose the filing of the on-body injector for UDENYCA. We’ve remained silent on that for a variety of strategic reasons. And you will probably hear about that upon approval and/or launch. With respect to the alternative dosage forms for CIMERLI, I’ll let Paul comment as to whether that comprises any barrier to entry in the shorter term. But again, we for competitive reasons, we have not disclosed the PFS timing in the market. But I think Paul is pretty bullish on its ability to proceed regardless. Paul?

Yes, thanks for your question. So look, you got to remember that before all these presentations were launched, it’s the vials that the doctors were using. So this is a very common and standard way that they can deliver these medications. And so we don’t see it as a major impediment to CIMERLI adoption. I think you can only point to the most recent example of Roche’s launch of Vabysmo, which is in a vial presentation. And you can see that the uptake for that has been quite steady. So I think that shows that when doctors want to use a product, they will use it, whether it’s a vial or PFS.

Good. Thank you, guys.

Our next question comes from the line of Douglas Tsao from H.C. Wainwright & Company. Please go ahead.

Good afternoon. Thanks for taking the question. Just Paul, going back to that point on the pre-filled syringe and the CIMERLI market. Do you expect there to be sort of some value offset that you need to make? Or do you think that, that will already be encompassed in sort of the value proposition that you’re offering as a product and that you won’t need to offer sort of an additional incentive for physicians? And do you have a sense of how much additional sort of work that puts into in terms of going from a pre-filled syringe versus putting it into a vial or taking it from a vial and putting into a syringe itself?

Yes. Thanks for your question, Doug. One of the core competencies that we have at Coherus and is demonstrated with UDENYCA early our understanding the whole dynamics of the buy-and-bill market. We see it from every perspective and know the complete value proposition. That includes some product portfolio, the characteristics of the brand, patient services as well as the contract all come into place. So we know what we need to do with the retinal specialists. And we’re going to deliver that irrespective of vial or the PFS. In terms of the timing of whether or not – or how much more time it takes to compare the vial versus the PFS, obviously, it’s takes a minute. But most retinal specialists have told us they either have their staff draw those up ahead of time. Or if they like to do it, they can do it in the room, and it only takes a few seconds them to pull it out of the vial. So again, I don’t think it’s a big deal kind of evidenced by that the Vabysmo in the launch.

Okay. Great. That’s helpful. And then just as a follow-up. I was just going to – Paul, in terms of – given now that you have a PDUFA date at the end of the year, can you just provide an update where you are in terms of the build-out of the commercial organization for toripalimab?

Yes. I mean we’re – it’s build out, Doug. I mean, we are leveraging our current oncology field-facing teams from our field sales representatives to our payer teams, key account teams, still reimbursement, where I just got oncology MSLs in the field. So everything is built for it. And this launch is expected earlier this year. Patient services moves have already been built out. So we’re ready to just flip the switch as soon as we get approval. So it’s we’re ready to go.

And should we expect that the launch, that happens right upon approval?

The PDUFA date is December 23, Doug. So I don’t think we’ll launch this [indiscernible] But I think we’ll get an early – I think your question is will we get an early 2023, yes. You may note in our remarks, we characterized it as very early in 2023. So that’s different than the – beyond the quarter so. Thank you for the questions.

Okay. Perfect. Thank you so much and congrats on the progress.

Thanks, Douglas.

Thank you.

Our next question comes from Kirsten Burgundy from the Bank of America. Please go ahead.

I think the question was for me maybe, Jason Gerberry. Can you guys hear me?

Yes. Hi, Jason.

Okay. Great. I was a little plumb by the introduction there. Maybe can you talk a bit about with the biosimilar Lucentis launch? How long do you think it will take to eat into the broader VEGF category and specifically products like Eylea? Is that something that you thought you can compete and grab share from a product like that early on? And then I guess the differentiation versus the other biosimilars. But as we think about the differentiation versus the brand, I have to think it’s either economic or payers forcing the decision or at least swing the decision to use the biosimilar. So can you help frame the economic trade-offs that you expect health care providers to face with a biosimilar versus the brand in this new world going into the second half? Are there other specific segments in the market that you think you have a better chance of winning? Maybe lower volume practices that didn’t get as good at discounts from, say, the innovators. Just curious where you think you’re best positioned to win?

Thanks for the question. I’ll let Paul take the first shot at that one. Paul, what do you – I guess the first issue is what do you think about – how do we think about going after the various segments, the Avastin reformulated shares, Lucentis shares and the Eylea portion of the market with VEGF, how do we sort of think about that?

Yes. Hi, Jason, thanks for your question. Yes. So I want to reiterate sort of what our primary strategy. And that’s to convert as much of the Lucentis business today. That’s the core opportunity that’s right in front of us. And our label, as you see with the interchangeability designation, will really give physicians a very high degree of confidence that the safety and efficacy of CIMERLI will provide them the same outcomes consistent with historical Lucentis experience. So we believe that that’s going to help drive conversion. That’s number one. But what we also know is that physicians choose VEGF products for a lot of different reasons. And on the commercial side of the business, where a payer might require them to step through Avastin. They’re very adept at transitioning patients off of that to another VEGF product. And we want to be well positioned to be that next brand. So that – our market research tells us that based on access, based on the practice economics, we have the ability to not only penetrate high degree of Lucentis but also those edges of Avastin and Eylea. So that’s going to be our strategy. And we’re not going to pick small versus big. There’s opportunity across the entire marketplace.

Yes. I think it’s a fair question, Jason. The other thing that I would point out, though, is that these practices use, in a lot of cases, all three flavors of these products. And to a significant degree, the Avastin reformulation product versus Lucentis versus Eylea are significantly therapeutically clinically, I would say, interchangeable. So to the degree that we get into the Lucentis market, establish a footprint featured and our credibility with the interchangeability designation, which we think is really important and then take significant portions of that market. We’re able to talk to those very same doctors who have Avastin patients, Eylea patients and inform them about the CIMERLI and the value proposition and so on. So as we’ve said before, we think this is an ideal place to enter over our chain VEGF market. Just how fast now the things go, we’ll probably be in a better place to talk about that after maybe Q1 of next year when we see how things are rolling out. But it’s a fair question.

All right. Thanks guys.

Thank you.

Our next question comes from Ash Verma from UBS. Please go ahead.

Thanks for taking my questions. So I have two. So one was just how are you thinking about the ramp for YUSIMRY? So obviously, like with you coming in mid-2023, do you think the contracting discussion will be revisited meaningfully for 2024 or the 2023 agreements are going to hold? So that’s question number one. The second one, I’m just trying to understand the mechanics of this interchangeability for CIMERLI. So when a physician writes a script something, is it by vial or PFS? Like in other words, can your product be interchangeable no matter what the script is? Or could it only be replaced for a vial formulation script?

Thanks for your question, Ash. Let me take the first one for – with respect to CIMERLI. We think that there will be of course, several market participants entering around that same point in July 2023 at the same time. We will be there for that. We think, yes, there will be significant sales in 2023 and significant contracting in 2023. Certainly, it will accelerate in the second year of 2024. But I would not say that the 2023 revenues or market penetration would be insignificant. I think all of licensees are pretty much in the same boat, came in that market at the same time. But we feel that we particularly have significant advantages with respect to our insights on the market and our ability to produce our cost structure and our volume structure and so on. With respect to your second question, I’ll pass that one over to Paul.

Yes. Thanks, Ash. So the interchangeability typically for products that are dispensed through the pharmacy allow pharmacists to do the conversion, right, so long as they have the interchangeable designation. This is a little bit nuanced because it’s a buy-and-bill market and the physicians are making the product decision, buying the drug, administering it and billing for it. So in this case, the interchangeability designation is really going to be enabling the – our ability to get confidence to the retinal specialists that they can safely convert patients already on Lucentis. And that’s the key point. It will give them outcomes consistent with their historical Lucentis experience. So that’s the nuance.

Got it. Thanks.

And that, of course, will allow you to drive some more conversion in the market. That’s why we are so thrilled to get that.

Our next question comes from the line of Douglas Tsao from H.C. Wainwright & Co. Please go ahead.

Hi. Thanks for taking the follow-up question. Just as a quick one, sticking to the subject of interchangeability, just Denny or Paul. Just curious, do you think this designation is more important for a buy-and-bill market like the anti-VEGF retina space than it is for something like with what you’ll face with Humira and YUSIMRY? Thank you.

Fair question, Doug. Yes, Paul, do you want to take a shot at that?

Sure, sure. So certainly, in YUSIMRY, Doug, that is a pharmacy benefit product and dispensed by specialty pharmacies. And because of the high-cost nature of that, payers and PBMs instituted restricted formularies. So they will be dictating the product selection. That’s why our expectation to deliver to payer with YUSIMRY a very competitive place, by guarantees and – and a product presentation similar to the originator is really important. That’s going to be key. And that’s why we didn’t pursue the interchangeability because at the end of the day, payers are going to make the decision. Now for the CIMERLI, as we mentioned, we know that retinal specialists are routinely switching patients from one therapy to another. But we also know that they’re really sensitive to inflammation in the eye. So this designation will give them, again, greater confidence they can expect the same safety and efficacy, which CIMERLI has been with Lucentis and therefore, will help us drive conversions of the current Lucentis patient population as well as new patient starts. But hopefully, that answers your question with the distinction there.

That’s helpful.

That concludes today’s questions. I would now like to turn the call over to Denny Lanfear, CEO, for closing remarks.

Thank you very much, and thank you all for joining us on our call today. I would just like to point out that we will be participating in the Citi and Wells Fargo conferences in Boston the week of September 4 and the H.C. Wainwright conferences in New York week of September 11. During September, we’re also going to have a number of non-deal road shows and answer on the call. So we look forward to seeing all of you. Thanks very much. Have a great day. Bye-bye.