Good day and thank you for standing by. Welcome to the Quarter 2, 2021 Coherus Conference Call. At this time, all participants are in a listen-only mode [Operator Instructions] I would now like to hand the conference over to your speaker today, McDavid Stilwell, Chief Financial Officer. Please go ahead, sir..

Thank you. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2021 second quarter results. This release can be found on the Coherus BioSciences website. Today's call includes forward-looking statements regarding Coherus' current expectations.

These statements include, but are not limited to, our ability to advance our biosimilar and immuno-oncology product candidates through development and registration.

Our commercialization of UDENYCA and other - potential products in the future, our ability to meet our R&D and SG&A expense guidance for 2021 as well as our uses of capital, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ from these statements.

These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in documents that we file with the Securities and Exchange Commission, specifically in our quarterly report on Form 10-Q for the quarter ended June 30, 2021 that we filed earlier this afternoon.

The forward-looking statements stated today are made as of this date and we undertake no duty to update such information, except as required under applicable law. With me on today's call are Denny Lanfear, CEO of Coherus; Paul Reider, EVP of Commercial Operations and Market Access; and Chris Thompson, Executive Vice President of Sales.

And I will now turn the call over to Denny..

Thanks, McDavid, and thank you all for joining us this afternoon. Today I'll provide updates on UDENYCA performance, our biosimilar pipeline and progress with toripalimab, our PD-1 antibody.

We're pleased with our progress since we transformed Coherus from a single product biosimilar company to a diversified multi-product biopharma company with multiple oncology assets. Over the next two years, we anticipate bringing four new products to market in the United States, complementing UDENYCA.

Our diversified product portfolio will generate growing and durable cash flows to invest in the large and rapidly developing immuno-oncology market with toripalimab as our foundational asset. Now, let me first turn to UDENYCA.

In the second quarter of 2021, we recorded $88 million in net sales of UDENYCA as compared to $83 million in the first quarter. UDENYCA market share as reported by IQVIA declined one point quarter-to-quarter from 20% to a 19% share.

Wholesaler inventory was stable in the second quarter compared to the prior quarter end and was not a factor in second quarter revenue. Recall the first quarter revenue was negatively impacted by the burn-off of about nine days of wholesaler inventory that accumulated the seasonal buy-ins at year-end 2020.

Later in the call, Paul Reider will provide additional details with respect to our expectations for the second half of UDENYCA performance. Now, let me update you on the excellent progress we're making with our biosimilar pipeline.

Together with UDENYCA, our biosimilars of Lucentis, Humira and Avastin, address an aggregate $28 billion in market opportunity. We've already demonstrated our ability to use our branded marketing and commercial capabilities to penetrate competitive areas with biosimilar.

We believe we will experience similar success taking significant share in these new biosimilar markets. Our objective is to take at least 10% in each of these new markets, and in some cases, as with UDENYCA, even greater market share. Our next expected biosimilar launch is CHS-201, our Lucentis biosimilar candidate.

I'm pleased to report that our partner, Bioeq recently submitted the BLA to the FDA. Assuming the filing is accepted for review, we anticipate a standard 12-month review and approval cycle.

We are excited about the potential approval of this product in 2022 and believe it will be among the first biosimilar Lucentis candidates to market, actively participating in the market formation. Launch planning is underway.

Now with respect to our Humira biosimilar, CHS-1420, the FDA review is progressing well, and we believe that the application is on-track for December 2021 target date. You may recall that we expect to launch CHS-1420 in the United States on or after July 1, 2023.

Regarding CHS-305, our Avastin biosimilar, we are currently conducting a three-way PK study to support BLA, which we expect to file in the first part of 2022.

Once approved, the Avastin commercial opportunity will further leverage our commercial oncology capabilities with nearly identical customer base as UDENYCA and toripalimab, adding incremental margin to our bottom line.

Now, let me make a few remarks with respect to toripalimab and provide you with a positive update regarding our BLA filing in nasopharyngeal carcinoma or NPC. As you may recall the registration strategy calls for filing the second and third-line NPC BLA and then post-approval filing a supplemental BLA for first-line treatments.

FDA has now agreed to accept the first-line submission for concurrent evaluation with the second and third-line data, thereby accelerating time to potential approval for the first-line indication.

JUPITER-02, the clinical trial evaluating toripalimab first-line NPC, generated strong progression-free survival and overall survival data that were presented this June in the preliminary session at ASCO.

The rolling BLA submission for all NPC indications is expected to be completed this quarter, and we continue to project approval in the first half of 2022. Now, I'm also pleased to report that toripalimab clinical data will be presented in September at two medical conferences.

Data from the Phase III first-line non-small cell lung cancer study, which we earlier reported had met the primary endpoint of progression-free survival, will be presented at the World Conference on Lung Cancer.

The JUPITER-06 Phase III study in esophageal squamous cell carcinoma, which also met its co-primary endpoint of progression-free and overall survival, will be featured at the Annual Meeting of the European Society for Medical Oncology.

Junshi continues to make good progress with additional toripalimab clinical trials in lung cancer, which represents approximately 45% of the PD-1 market opportunity.

Phase III/B studies evaluate toripalimab and neoadjuvant at small cell lung cancer and EGFR positive patients with failed TKI treatment are enrolling rapidly with data expected next year.

Phase II study in small cell lung cancer with co-primary endpoints of progression free and overall survival is now fully enrolled and is also expected to readout in 2022. You will find details of these studies on Slide 20 of the August Investor Presentation which we posted to website earlier today.

Beyond lung cancer in 2022, we also project data from a Phase III study in first-line treatment of triple-negative breast cancer and two Phase III trials in hepatocellular carcinoma. One for the first-line treatment and one in the neoadjuvant setting, as detailed on Slide 21 of the Investor Presentation.

Toripalimab is the foundation of our immuno-oncology franchise and developing in combination with other agents that can improve response rate is a key part of our strategy. JS006, the TIGIT antibody for which we have option rights is now being evaluated by Junshi in a Phase I clinical trial, and is progressing well.

I'll now turn the call over to Paul Reider, our Executive Vice President of Commercial Operations and Market Access for some additional color on the market dynamics we see going forward for UDENYCA.

Paul?.

Thank you, Denny. The pegfilgrastim market grew approximately 2% quarter-to-quarter. UDENYCA ended the quarter with 19% share of the overall pegfilgrastim market. This 1% decline in UDENYCA market share in the quarter came primarily from the least profitable segment of the market for 340B hospitals.

Since the end of 2020, overall Neulasta shares declined 5 percentage points, validating customers' willingness to move away from Onpro, and we expect this trend to continue. Going forward, despite the COVID pandemic, we believe that taking share for Onpro will be a source of growth for biosimilars and especially for UDENYCA.

We are projecting market share within the second half of 2021, driven by the stability in our third quarter ASP compared to competitor ASPs and the redeployment of our field teams to in-person sales calls. With respect to revenues, we expect modest second half growth compared to the first half of 2021.

However, there are two major uncertainties that are largely beyond our control, therefore difficult to handicap. First is COVID resurgence with dependent impact on market growth, share movement and sales force access. And the second is the level of price erosion precipitated by our competitors.

We remain confident in our ability to respond quickly to manage either challenge to maximize our available opportunities. I'll now turn it back over to McDavid for a review of the quarter's financial results..

Thanks, Paul. The details of our financial results are in the press release and in the 10-Q we filed this afternoon. So I'll focus now on just a few highlights. For the second quarter of 2021, we reported $29.9 million net loss on a GAAP basis.

Cash flow from operating activities was essentially breakeven at negative $200,000 for the second quarter of 2021. As detailed earlier in the call, net product revenue was $88 million, an increase from the $83 million in UDENYCA net sales recorded in the prior quarter. Wholesaler inventory was stable compared to the prior quarter end.

Cost of goods as a percentage of net revenues increased from the prior quarter. In the first quarter, we depleted the inventory manufactured and fully expensed prior to UDENYCA approval. And so the second quarter was the first period with per unit acquisition costs fully reflected within COGS.

We expect a similar gross margin in the third quarter and then an improvement in the fourth quarter. For the full year 2021, we expect gross margins of around 85%, including a mid-single-digit royalty we owe through mid-2024.

In the long run, starting in 2024, we expect UDENYCA gross margins to return to 90% or higher as we realize the benefits of a significant manufacturing process improvement and royalty expiration. Research and development expenses for the second quarter of 2021 were $54.8 million compared to $26.2 million for the same period in 2020.

The increase reflects cost to advance our late-stage pipeline. Recall that we expect to bring four additional products to market in the next two years, and we are investing in activities such as regulatory affairs and manufacturing [stem] up for CHS-1420, development and BLA filings for toripalimab and a clinical trial for CHS-305.

R&D expense for the quarter was partially offset by a $9 million credit due to the accounting treatment of the Coherus equity purchased by Junshi Biosciences in the second quarter. Selling, general and administrative expenses were $40.3 million in the second quarter of 2021 as compared to $34.1 million in the year ago quarter.

The increase was primarily driven by higher stock-based compensation expense as well as UDENYCA commercialization activities, which increased compared to the year ago quarter, which was heavily impacted by the COVID lockdowns of the spring of 2020.

We ended the second quarter with cash, cash equivalents and marketable securities of $454.4 million compared to a balance of $399.5 million at March 31, 2021. And recall that during the second quarter, Coherus received $50 million from Junshi Biosciences purchasing of common stock associated with the toripalimab licensing transaction.

We are maintaining our full year guidance for R&D and SG&A expenses of $370 million to $400 million, excluding the first quarter upfront payments to Junshi Biosciences, and this range includes approximately $50 million to $55 million in stock-based compensation expense. And I'll now turn the call back to Denny for closing remarks..

Thank you, McDavid. In closing, I'd like to congratulate and thank my colleagues and teammates at Coherus on the strong progress we are making on the transformation to a diversified biopharma company with multiple products in oncology. Their hard work is very much appreciated.

The results of our team's efforts are two products currently in the registration process, plus a third BLA soon to be filed for toripalimab. We're advancing rapidly on our objective to transition from one approved product UDENYCA to four approved products in the United States over the next year.

In 2023, we expect to have five products launched and generating revenue. Over the next several months, we anticipate clinical data announcements, medical presentations and regulatory milestones for both our biosimilars and toripalimab.

We look forward to providing updates through the fourth quarter, when we'll have our Analyst Day event in New York City. Operator, we can now turn the line over to questions. Thank you..

[Operator Instructions] Our first question from the line of Douglas Tsao of H.C. Wainwright. Sir, your line is open..

Hi good afternoon, thanks for taking the questions. Just Denny as a starting point just curious to hear your perspective in terms of what we're seeing in the UDENYCA market. It seems like from the biosimilar makers pricing, has sort of stabilized, but the innovator continues to sort of take some pricing discount.

How do you see that playing out through the balance of the year?.

Hi, Doug thanks for the question. Yes, I'll hand that question over to Paul Reider, our Executive VP of Marketing. Paul, would you like to address that question..

Yes, sure, Denny. Yes I mean, we definitely are watching the race to the bottom from Amgen in pushing the price down. They have the lowest ASP in market.

And really for biosimilar competitors really need to recognize that the meaningful growth will only come from taking share from the originator and swapping growth among biosimilars is not a sustainable strategy. From a pricing standpoint, our Q3 published ASP has increased 1% over Q2. So by comparison to the originator, you can see the declines there.

But we remain focused on value over the long-term and to maintain the highest ASP price while maximizing share..

And another question, I know we're - it's maybe a little early, but just looking ahead to 1420, just curious at what point just given you said the likelihood of approval at the end of this year and then launching 18 months later? Would we expect to see some commercial build-out for that product?.

That's a great question, Doug. We are currently performing some market research around the potential structure for the sales force. But we are on record earlier as indicating that we believe that will be primarily a payer-driven market access driven operation. So we do not see substantial increases on the commercialization side to support that product.

Although, there probably will be some marginal increases, but not substantial..

Okay.

And so just given the fact that you're not going to be spending that much, would we anticipate those would be sort of stream on just a few months before the actual launch?.

I'll decline to actually, at this point, describe the breadth of our efforts in various places of the organization to support that. But we do not expect, for example, to put a substantial number of boots on the ground to move that product..

Next question from the line of Salim Syed of Mizuho. Sir, your line is open..

Great, thanks so much for the question guys and good afternoon, so a couple from me if I can one on - actually both on UDENYCA. So, when we look at the data, it looks like the ZIEXTENZO is starting to pick up a little bit more share, pegfilgrastim share more quickly now than previously, even though they have a slightly higher ASP from using.

Just wondering if you could just give us a little bit more color with the dynamic there? And then the second on your on-body device, given the trial mentions on clinical heroes, et cetera, and some of the data points. It seem to me to suggest that we could get data potentially this summer or early fall from those trials.

Is that a correct assumption or when do you expect we should be able to get some data from there? And what does it mean for you to potentially be the only biosimilar with an approved on-body device, if that were to occur? Thank you..

Well, thanks for the question, Salim. I'll take the first - second question rather first, and I'll let Paul address ZIEXTENZO and so on. With respect to the on-body device, I think that we would reiterate our previous comments that we are pleased with the progress that we are making with respect to that product.

As you know, we have had some, expenditures disclosed over the past year for other delivering modalities for UDENYCA. And I'll probably decline to give you timelines for data. But I think that product is moving along.

Paul, do you want to say a little bit about ZIEXTENZO and what's going on in the market?.

Yes, sure. Hey Salim, I'm going to reiterate our focus here at Coherus, which is to gain share from Onpro. It's got over 50% of the market. It's likely that any of the new biosimilar entrants we're going to pick up a couple of share points for now. What we're seeing is their share is coming from primarily that 340B segment.

It's the least profitable segment for us. So that's where we're seeing some market share gains. It's been our focus is really to take share for Onpro, both in the short and long-term..

The next question from the line of Chris Schott of JPMorgan. Your line is open..

Great, thanks so much for the questions. Just one on UDENYCA and then a bigger picture one. On UDENYCA, I think - sorry if I misheard this. During the prepared remarks, I think you expected ASP stability going forward.

I didn't know, is that relative to peers or on an absolute basis? As I think about price going forward is, the more stable dynamic, is that mix driving that or are you actually seeing some of competitive dynamic in the space maybe starting to normalize a bit? And then my bigger picture question, I think you've talked about building out the I-O portfolio over time, but there also seems to be a lot of opportunities, I guess, in the broader oncology market.

So would there be any interest in the company to add, I guess, non I-O oncology assets to the mix and that there's obviously some very large spaces there? There seems to be a number of ex-U.S. kind of me too assets being developed there as well.

And just to know is what the strategy is, could that be something you look at as well or is the focus very much on I-O specific assets? Thank you..

Thank you for the question, Chris. Let me take the ASP question first. As you know, we consider ourselves to be good guardians of ASP. We try to keep our prices, our price decrease as modest as possible. And I think our track record and our ASP record reflects that.

That being said, we can't control the pricing behavior of other competitors in the market, regardless of their motivations and so on. We are currently somewhat stable with our ASP for this quarter. But looking forward, several quarters in the future, there might be additional changes and decreases as required.

With respect to oncology products, I think you bring up a very interesting point. We of course, currently have a few immuno-oncology products that came over with the Junshi collaboration, the TIGIT, engineered IL-2, et cetera. Our focus is on the cancer immunity cycle.

But I think it's fair to say that in conjunction with toripalimab, our PD-1, we are now getting a fair amount of incoming overtures, partnered overtures for various assets to use with toripalimab. So, I think fair to say that we remain open-minded about the assets that we look at.

But I would also say that the Junshi TIGIT is sort of front and center for us as that data reads out - end of the year and into 2022. We are seeing significant - our entry into the market with the PD-1 though is causing significant interest..

[Operator Instructions] Next question from line of Jason Gerberry of Bank of America. Sir, your line is open..

This is Ashwin on for Jason. So I have two, one is on Humira. So it looks like AbbVie is now saying that they expect two interchangeable biosimilars.

And we've seen the first two interchangeable biosimilar getting approval recently? So to what extent is your 10% projected share predicated on any assumption around biosimilar, either for you or for competitors, that's the first one.

And the second one, just on gross margin and so you say that, I think 85% in 2021 should we expect around the same level for 2022 and 2023 before it jumps to 90% in 2024? Thanks..

Thanks for your question. I'll let McDavid take the gross margin question. I'll speak to the issue of interchangeability with Humira. We don't believe that the lack of interchangeability is a significant impediment to market penetration. We think it's more for your apps of a segmentation issue.

And as we've said previously, we believe that the payers will probably have the loudest voice in terms of selection of the biosimilar of choice for them. So we look forward to that. And we consider ourselves to be very adept biosimilar competitors.

And we think that we will do very, very well in the market, which is the reason why we are projecting 10% of raise at market share for the Humira biosimilar post entry. Now with respect to your questions on gross margins and so on, I'll let McDavid, to address of that.

McDavid?.

Yes, thanks, Ash. So as we said in the prepared remarks, the second quarter was the first period in which the full per unit acquisition cost of UDENYCA was realized. And so that was mostly responsible for the increase in the cost of goods as a percent of net price or net sales.

I would add though that there was a separate element to the second quarter, and it will also be available and obvious in the third quarter that the actual lots of UDENYCA. That we were utilizing in the second and in the third quarters were lots that were manufactured prior to a process improvement.

And so, those lots actually were relatively low-yielding lots and, therefore, more expensive lots. And we expect to move through those by the end of the third quarter and then for gross margin to come back down from that point in the fourth quarter and to be relatively stable through 2022 and 2023.

So that's the trajectory that we expect for cost of goods..

[Operator Instructions] There are no further questions. Presenters, please continue..

Thank you very much for joining us today. Again, thank you very much. We look forward to providing you with another update on our next quarterly call, and we look forward to seeing you at our Investor Day in New York in Q4. Thank you..

That concludes today's conference call. Thank you everyone for participating. You may now all disconnect..