Q4 2020 Coherus BioSciences Inc Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the fourth quarter and full year two minus Randy go on here is by Science Conference call.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the 4th quarter and full year 2020 Coherus BioScience conference call. At this time, all lines are in a listen only mode. Later, we will conduct a question and answer session, and instructions will follow at the time. If anyone should require assistance during the conference, please press star and zero on your touchtone telephone. I would now like to turn the conference over to your host today, Mr. McDavid Stilwell. Sir, please go ahead.

This time all participants lines are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at the time, if any once you get smart assistance. During the conference. Please press Star then zero on your Touchtone telephone I would now like to turn the conference over to your host today, Mr. Mcdavid Stilwell.

Please go ahead.

McDavid Stilwell: Thank you. Good afternoon, everyone, and thank you for joining us.

Thank you.

Good afternoon, everyone and thank you for joining us.

McDavid Stilwell: We issued a press release earlier announcing our 2020 fiscal year and fourth quarter results, and the 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 Udenica and other potential products in the future, and our ability to meet our R&D and SG&A expense guidance for 2021, as well as our use 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.

We issued a press release earlier announcing our 2020 fiscal year and fourth quarter results in the release can be found on the coherent <unk> Biosciences website.

Today's call includes forward looking statements regarding co Harris as 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 your deneke 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.

McDavid Stilwell: 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 September 30, 2020. 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. Joining me for today's call are Denny Lanfear, Chief Executive Officer; Jean Biret, Chief Financial Officer; Vince Anacetti, Chief Operating Officer; and Chris Thompson, Executive Vice President of Sales. I'll now turn the call over to Denny.

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 September 32020.

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.

Joining me for today's call are Ginnie Lanphier, Chief Executive Officer, Zombie Ray Chief Financial Officer.

Vincent <unk>, Chief operating Officer, and Chris Thompson Executive Vice President of sales.

I'll now turn the call over to Denny.

Dennis M. Lanfear: Thank you, McDavid, and welcome everyone to our call. This afternoon, I will review recent business highlights and pipeline progress. Chris will provide his perspective on Peckville-Graston market dynamics and fourth quarter Udenka performance. And John McDavid will discuss fourth quarter and full year 2020 financial results, as well as expense guidance for 2021. We'll then open the call for questions.

Thank you Mcdavid and welcome everyone to our call. This afternoon I will review recent business highlights and pipeline progress Chris will provide his perspective on pegfilgrastim market dynamics and fourth quarter your debt to performance.

And John Mcdavid will discuss fourth quarter and full year 2020 financial results as well as expense guidance for 2021.

Well then open the call for questions.

Dennis M. Lanfear: Certainly, COVID-19 made 2020 a difficult year for Udenica, impacting our ability to grow market share as planned in the face of new competitive entry. While there will be some continued price share competitive pressure on Udenica sales in early 2021. We expect that as COVID recedes, we will see market share growth, largely coming at the expense of new last design pro. We see 2021 as a year of fundamental transition and an inflection point for Coherus.

Certainly COVID-19 made 2020, a difficult year for Ya deneke impacting our ability to grow market share as planned in the face of new competitive entrants.

While there will be some continued price share competitive pressure on your dental sales in early 2021, we expect that as Covid recedes, we will reserve market share growth largely coming at the expense of Neulasta is on pro.

We see 2021 is a year of fundamental transition and an inflection point for careers.

Dennis M. Lanfear: We are extending our mission and expanding our late-stage pipeline to include immuno-oncology with our recently announced collaboration with Junshi Biosciences for U.S. and Canada rights to the PD-1 inhibitor, torepalumab. The transaction is projected to close later this quarter. ToroPalumab is being evaluated for a wide range of tumor types in 15 ongoing or completed registrational trials. We eagerly anticipate the first BLA to be filed this year for nasal pharyngeal carcinoma, which has been granted breakthrough therapy designation by the FDA.

We are studying our mission and expanding our late stage pipeline to include immuno oncology with our recently announced collaboration with UMC Biosciences for U S and Canada rights to the PD, one inhibitor Troy Palomar.

The transaction is projected to close later this quarter.

Tore Palomar was being evaluated for a wide range of tumor types and 15 ongoing or completed Registrational trials.

We eagerly anticipate the first BLA to be filed this year for nasal pharyngeal carcinoma, which has been granted breakthrough therapy designation by the F. D. A.

Dennis M. Lanfear: Earlier this month, TOR-PALMAB was approved in China for this indication, and regulatory authorities there have also begun a review of Tora Palamed for first-line treatment of nasal pharyngeal carcinoma. Over the next few years, we expect the extensive clinical development program to support multiple BLA submissions for rare and highly prevalent diseases... including lung cancer.

Earlier this month tour Palomar was approved in China for this indication.

And regulatory authorities there and have also begun the review of Torah Palomar for first line treatment of nasal pharyngeal carcinoma.

Over the next few years, we expect this extensive clinical development program to support multiple BLA submissions for rare and highly province tumor types, including lung cancer.

Dennis M. Lanfear: As the label expands with new indications, we project significant revenue and sustained growth will follow. Evaluating Toripalumab in combination with other immuno-oncology agents will provide longer-term growth opportunities. As part of the collaboration, we will obtain options on the anti-TIGIT antibody and an engineered IL-2 cytokine, as well as certain negotiation rights to two other immuno-oncology molecules. Once the transaction is closed, Junshu Biosciences will purchase $50 million of Coherus Commons stock, an investment they wanted to make to share our future growth and mutual success with these programs.

As the label expands with new indications, we project significant revenue and sustained growth trajectory will follow.

Evaluating toward Pal Nat in combination with other immuno oncology agents will provide longer term growth opportunities.

As part of the collaboration we will obtain options on anti <unk> antibody and an engineered IL two cytokine as well as certain negotiation rights to two other immuno oncology molecules.

Once the transaction is closed June she biosciences will purchase $50 million of coheres common stock an investment they wanted to make to share our future growth and mutual success with these programs.

Dennis M. Lanfear: Later this year, we plan to host an Analyst Day event to provide a deep look at all aspects of our business, our biosimilars business, Tora Palamed, the option programs, and our immuno-oncology strategy. Turning now to our core biosimilar business, I'm pleased with how our team performed in the face of COVID-19 headwinds through most of 2020. Udetica net sales of $476 million for 2020 drove $154 million in cash flow from operations for the year. Chris will describe Edenica's performance in more detail in just a few moments for you.

Now later this year, we plan to host an analyst day event to provide a deep look at all aspects of our business. Our Biosimilars tour Palo man the option programs in our immuno oncology strategy.

Turning now to our core Biosimilar business I'm pleased with how our team performed in the face of COVID-19 headwinds through most of 2020.

<unk> net sales of $476 million for 2020 drove a $154 million in cash flow from operations for the year.

Chris will describe your debt performance in more detail in just a few moments for you.

Dennis M. Lanfear: First though, let me review recent pipeline progress in the biosimilar business. With respect to our Humeyra Biosimilar... CHS 1420. The FDA has accepted our BLA for review with a December 2021 action date. Now the anti-TNF market represents a substantial opportunity for Coherus. After years of double-digit price increases with Humira, there is clearly significant pent-up demand for the type of biosimilar value that Coherus will deliver. There will be a payer-driven dynamic, and payers are heavily incentivized to force switching from the brand to the biosimilar.

First though let me review recent pipeline progress and our Biosimilar business.

With respect to our Humira biosimilar.

<unk> 14 20.

The FDA has accepted our BLA for review with the December 2021 action date.

On the anti TNF market represents a substantial opportunity for colliers.

After years of double digit price increases, which you Myra, there's clearly significant pent up demand for the type of biosimilar value that coheres will deliver.

There will be payer driven dynamic and they are heavily incentivized to force switching from the brand to Biosimilars.

Dennis M. Lanfear: Our product, our patient-focused offering, and our manufacturing scale will match what payers are looking for. We are making manufacturing and supply investments to support our objective of capturing greater than a 10% market share. I'm also pleased to provide an update on our Lucentis biosimilar product candidate being developed by our partner, BioX. The FYB 201 BLA is on track for a mid-year 2021 submission, following a supportive pre-BLA meeting with the FDA earlier this quarter. As the sponsor of the BLA, BioEc reviewed multiple elements of the plan filing, including the manufacturing data that the FDA requested last year.

Our product our patient focused offering and our manufacturing scale will match with payers are looking for.

We are making manufacturing and supply investments to support our objective of capturing greater than a 10% market share.

I'm also pleased to provide an update on on Lucentis Biosimilar product candidate being developed by our partner biotech.

The F Y B two O. One BLA is on track from mid year 2021 submission.

Following a supportive pre BLA meeting with the FDA earlier this quarter.

As the sponsor of the BLA biotech reviewed multiple elements of the planned filing including the manufacturing data that the FDA requested last year.

Dennis M. Lanfear: We're very excited about the potential approval of this product in 2022. Ophthalmology has a similar buy and build business model to oncology with analogous critical success factors that our commercial team understands very well. We plan to leverage much of our existing infrastructure and core sales and marketing skills to gain a significant share of the overall $6 billion antique VEGF ophthalmology market. Regarding IBI-305, our Avastin Biosimilar product candidate, in partnership with InnoVest, we have initiated a three-way PK study, and we expect to provide additional updates on this program later this year.

We're very excited about the potential approval of this product in 2022.

Ophthalmology has a similar buy and build business model to oncology with analogous critical success factors that our commercial team understands very well.

We plan on leverage much of our existing infrastructure and core sales and marketing skills to gain a significant share of the overall $6 billion anti VEGF ophthalmology market.

Okay.

Regarding <unk> 305, our Avastin Biosimilar product candidate and partnership with Internet.

We have initiated a three way PK study and we expect to provide additional updates on this program later this year.

Dennis M. Lanfear: Our biosimilar portfolio, which includes Udenica and biosimilars of Lucentis, Avastin, and Humira, addresses a $28 billion market opportunity. We've already demonstrated our ability to use our branded marketing and other commercial capabilities to penetrate competitive markets with our biosimilars. We believe we will experience similar success taking a significant share in these new markets. We plan to invest the cash flows from the biosimilar business to build a robust and growing immuno-oncology franchise, based on our strong Udenica performance and advancing biosimilar pipelines, together with Tora Powell. Demonstrate solid progress on this strategy as we pursue the $25 billion PD-1 market opportunity. I'll now turn the call over to Chris Thompson for an overview of Udenica's performance and the Pikesville-Grafton market dynamics. Chris.

Our biosimilar portfolio, which includes your deneke, and Biosimilar, lucentis or Avastin and Humira.

Dresses on $28 billion market opportunity.

We've already demonstrated our ability to use our branded marketing and other commercial capabilities to penetrate competitive markets with a biosimilar.

We believe we will experience similar success, taking significant share in these new markets.

We plan to invest the cash flows from the Biosimilar business to build a robust and growing immuno oncology franchise, our strong you've done on <unk> performance and advance our Biosimilar pipeline together with a tour palmette demonstrates solid progress on the strategy as we pursue the $25 billion of PD one market opportunity.

I'll now turn the call over to Chris Thompson for an overview of the <unk> performance and the Pegfilgrastim market dynamics Chris.

Chris Thompson: Thank you, Denny. 2020 was a successful successful year for Udanica despite the challenges of COVID. In the fourth quarter, we delivered $110 million in net sales, driven by an increase in units that was offset by price decreases and a larger percentage of our units coming from 340B accounts. Share remained relatively stable in the fourth quarter, while the overall PEG progressed the market group 4% quarter over quarter in volume.

Thank you Denny 2020 was a successful a successful year for you danica despite the challenges of Covid.

In the fourth quarter, we delivered $110 million on net sales driven by an increase in units that was offset by price decrease and a larger percentage of our units coming from $3 40, B accounts share.

Share remained relatively stable on the fourth quarter, while the overall pegfilgrastim market grew 4% quarter over quarter on volume.

Chris Thompson: We ended the year with wholesale inventory at the higher end of the normal range, as is typically seen with most drugs in December, as we saw in 2019 as well. In retrospect, the primary impact that COVID had on our business last year was to make it more difficult for biosimilar pre-filled syringe competitors to take market share from Amgen's on-body device during the spring and fall surges. To a lesser extent, overall market volume was impacted, with full-year growth at 1% down from the historical mid-single-digit growth rate.

We ended the year with wholesale inventory at the higher end of the normal range as is typically seen with most drugs in December as we saw in 2019 as well in.

In retrospect, the primary impact that Covid had on our business last year was to make it more difficult for Biosimilar prefilled syringe competitors to take market share from amgen's on body device during the spring and fall surges to a lesser extent overall market volume was impacted with full year growth at one <unk>.

<unk> down from the historical mid single digit growth rates.

Chris Thompson: Looking forward, as vaccination rates increase and COVID recedes, we anticipate greater customer desire to capture the potential savings represented by biosimilars in general, and eudeneca in particular. Specifically, we see greater than 50% share currently represented by New LASTA OnPro as a highly accessible source of eudeneca growth in 2021. While we're not providing specific revenue guidance, we do expect Udenica revenues in 2021 compared to 2020 to be lower. While the first quarter will remain challenging due to COVID-19, seasonal impacts, growth to net, and a depletion of the inventory that built up at the end of the year, we expect revenue growth to resume in the second quarter.

Looking forward as vaccination rates increase and Covid receipts, we anticipate greater customer desire to capture the potential savings represented by Biosimilars in general and you've deneke in particular.

Specifically, we see greater than 50% share currently represented by Neulasta on pro as a highly accessible source of <unk> growth in 2021.

Well, we're not providing specific revenue guidance, we do expect you deneke revenues in 2021 compared to 2020 to be lower.

While the first quarter will remain challenging due to COVID-19 seasonal impact.

Gross to net and the depletion of the inventory that built up at the end of the year, we expect revenue growth to resume in the second quarter.

Chris Thompson: As post-COVID behavior normalizes, we expect to see share gains resume going forward, primarily at the expense of new ASFA, and the market to return to historical growth rates. The most challenging variable for us to forecast and the one over which we have the least control is, of course, price. That said, our goal is to remain disciplined, as we have been in our long-term management of ASP, while also remaining competitive. We would expect our competitors to operate in this rational manner as well. With that, I'll turn the call over to John.

As post Covid behavior normalizes, we expect to see share gains resume going forward, primarily at the expense of Neulasta and to see the market return to historical growth rates.

The most challenging variable for us to the forecast and the one over which we have the least controls of course price.

That said our goal is to remain disciplined as we have been in a long term management of Asps.

While also remaining competitive.

We would expect our competitors to operate in this rational manner as well with that I'll turn the call over to John.

McDavid Stilwell: Thank you, Chris. In addition to the brief financial overview I will provide on the call today, you can read additional detail on our fourth quarter and year-end financial results in our press release earlier today and in our Form 10-K, which we plan to file with the SEC tomorrow. We recorded 110 million net sales of Udenica for the fourth quarter of 2020, compared to 124 million for the same period in 2019.

Thank you Chris in addition to the brief financial overview I will provide on the call today, you can read additional detail on our fourth quarter on yearend financial results in our press release.

Earlier today and in our form 10-K, which we plan to file with the SEC Tomorrow.

We recorded 110 million of net sales of you Denny cash for the fourth quarter of 2020 compared to $124 million from the same period 2019. The decline was primarily due to a decrease in net selling price due to increased competition, partially offset by an increase in the number of units.

McDavid Stilwell: The decline was primarily due to a decrease in net selling price due to increased competition, partially offset by an increase in the number of units of Udenica sold. For 2020, we recorded $476 million in eugenics net sales compared to $356 million for 2019, an increase of $120 million. The increase was primarily due to an increase in the number of units of Udenica sold, partially offset by a decrease in net selling price.

Denny has sold.

For 2020, we recorded $476 million and you Denny can net sales compared to $356 million for 2019, an increase of $120 million.

The increase was primarily due to an increase in the number of units of you Denny has sold partially offset by a decrease in net selling price.

McDavid Stilwell: R&D expense rose in the fourth quarter of 2020 to $45 million, compared to $35 million for the same period in 2019. The increase was primarily attributable to clinical development activities, as well as payments for certain negotiation rights for pipeline development. For the full year 2020, we recorded $143 million in R&D expenses, an increase of $49 million compared to 2019. The increase was primarily attributable to activities supporting the BLE submission for CHS1420 and development activities related to other biosimilar product candidates.

R&D expense rose in the fourth quarter of 2020 to 45 million compared to $35 million from the same period in 2019. The increase was primarily attributable to clinical development activities as well as payments for sort of negotiation rights for pipeline development from our full year 2020.

We recorded $143 million in R&D expense and increase of $49 million compared to 2019.

The increase was primarily attributable to activities supporting the BLA submission for CHS, 14, 20 and development activities related to other biosimilar product candidates.

McDavid Stilwell: Selling, general, and administrative expense was relatively unchanged quarter over quarter. $38 million in the fourth quarter of 2020 versus $36 million in the same period in 2019, and year-over-year $139 million in 2020 versus $137 million in 2019. We reported a net income of $10 million, or $0.12 per share on a diluted basis, in the fourth quarter of 2020 and $132 million, or $1.62 per share, for the full year 2020.

Selling general and administrative expense was relatively unchanged quarter over quarter $38 million in the fourth quarter of 2020 versus $36 million in the same period in 2019.

And year over year $139 million in 2020 versus $137 million in 2019.

We reported a net income of $10 million of <unk> 12 per share on a diluted basis in the fourth quarter of 2020 and $132 million or $1 six two cents per.

Per share on a diluted basis for the full year of 2020, we generated $154 million in cash flow from operations in 2020 and at year end, we had a strong balance sheet with private on $41 million of cash on cash equivalents I'll now turn the call to Mike David towards your expense guidance for.

McDavid Stilwell: We generated $154 million in cash flow from operations in 2020, and at year end, we had a strong balance sheet with $541 million of cash and cash equivalents. I'll now turn the call over to McDavid to review expense guidance for 2021.

2021.

McDavid Stilwell: Thank you, Sean. In 2021, we anticipate combined R&D and SG&A expenses in the range of $310 million to $350 million, excluding upfront milestone and development expenses related to the recently announced collaboration with Jun-Chi Biosciences, which is expected to close in the first quarter. We project $45 million to $50 million of stock compensation expense for the year. The increase that we project in our operating expenses is primarily attributable to activities to advance our late-stage biosimilar portfolio, including manufacturing-related activities in preparation for the potential launch of CHS 1420, if approved, and development activities for IBI 305.

Thank you Sean.

In 2021, we anticipate combined R&D and SG&A expenses in the range of 310 million to $350 million, excluding upfront milestone and development expenses related to the recently announced collaboration with <unk> Biosciences, which is expected to close from the first quarter.

We project $45 million to $50 million of stock compensation expense for the year.

The increase that we projected in our operating expense is primarily attributable to activities to advance our late stage biosimilar portfolio.

Including manufacturing related activities in preparation for the potential launch of CHF 14, 20, if approved and development activities for Ipi 305 for.

McDavid Stilwell: For Udineka, we are investing in marketing activities and in the development of additional presentations of the product. Before I close, on the IR front, I'll note that we're scheduled to present at the Cowan Health Care Conference on March 1st at 4 p.m. Eastern Time and at the Barclays Conference on March 9th at 1.15 p.m. Eastern Time. And now, I'll turn the call back to Denny. Thank you.

<unk>, we are investing in marketing activities and in the development of additional presentations of the product.

Before I close on the IR front I'll note that we are scheduled to present at the Cowen Healthcare conference on March one at four P. M. Eastern time and at the Barclays Conference on March 9th at 115 PM Eastern time.

And now I'll turn the call back to Denny.

Dennis M. Lanfear: Thank you, McDavid. As you can see, we are successfully positioning Coherus for sustained future revenue growth. On the biosimilar side of the business, over the course of 2021, our progress towards growing and diversifying our product portfolio will become increasingly visible. In the next two years, we have the potential for approvals for biosimilars of Humira, Lucentis, and Avastin. We believe that this product portfolio will deliver significant revenue growth and strong cash flows for our continued investment in immuno-oncology.

Thank you Ms. David as you can see we are successfully positioning coherence for sustained future revenue growth.

On the Biosimilar side of the business over the course of 2021, our progress towards growing and diversifying our product portfolio will become increasingly visible.

And the next two years, we have the potential for approvals for Biosimilars of Humira Lucentis and Avastin.

We believe that this product portfolio will deliver significant revenue growth and strong cash flows for our continued investment in immuno oncology.

For immuno oncology, we expect the first tour Palomas BLA filing this year for nasal pharyngeal carcinoma with potential approval in 2022.

15 pivotal clinical trials are underway additional BLA will fall over the next three years from both rare and highly prevalent cancers, including non small cell lung cancer.

Dennis M. Lanfear: For Immuno-Oncology, we expect the first toropalumab BLA filing this year for nasopharyngeal carcinoma with potential approval in 2022. Fifteen pivotal clinical trials are underway. Additional BLAs will follow over the next three years for both rare and highly prevalent cancers, including non-small cell lung cancer.

Several interactions with the FDA our plans for the remainder of this year as we finalize the registration strategy for these additional indications.

We believe PD ones will be the foundation for immunocompromised therapy.

For the foreseeable future increasingly used in combination with novel agents that synergistically enhance their activity.

Dennis M. Lanfear: Several interactions with the FDA are planned for the remainder of this year as we finalize the registration strategy for these additional indications. We believe PD-1s will be the foundation for immunocology therapy for the Foreseeable Future, increasingly used in combination with novel agents that synergistically enhance their activity. We are excited by the option programs we have with Jun-Chi Biosciences for their TIGIT targeted antibody and their engineered IL-2 cytokine in combination with toropalamin.

We are excited by the option programs, we have with Junichi biosciences for their targeted antibody and their engineered IL, two cytokine and combination with tour of Palomar.

We also anticipate that other companies or academic institutions may well bring forward novel compounds to evaluate in combination with Toro Palomar.

Strategically, we see such business development activities as another way to extend our immuno oncology franchise.

And to drive additional tour palomas share and to advance our new treatments for the benefit of patients.

Dennis M. Lanfear: We also anticipate that other companies or academic institutions may well bring forward novel compounds to evaluate in combination with toropalamin. Strategically, we see such business development activities as another way to extend our immuno-oncology franchise and to drive additional toropalumab sales and to advance our new treatments for the benefit of patients. After launch, we expect Toropalmab to grow consistently into an expanding market year after year as additional indications are added to the label.

After launch we expect <unk> to grow consistently into an expanding market year after year as additional indications are added to the label.

And finally before we turn to your questions I want to thank my good friend, Sean for a for his years at coherent.

John joined before our IPO and Brian has considerable capabilities to bear as we commercialized our first product.

On the JV leadership careers developed a very strong finance and accounting function and for that we are especially grateful.

John leaves us in very good favorite and we wish him the very best.

Thank you JV on.

Operator: And finally, before we turn to your questions... I want to thank my good friend Jean Verret for his years at Coherus. John joined us before our IPO and brought considerable capabilities to bear as we commercialized our first product. Under JV's leadership, Coherus developed a very strong finance and accounting function, and for that, we are especially grateful. John leaves us in very good favor, and we wish him the very best. Thank you, JV. I'll now ask the operator to open the column for your questions.

Now I'll ask the operator to open the call to your questions.

Thank you ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchtone telephone.

Question has been answered or you wish to remove yourself from the queue. Please press the husky.

Two questions on each participants to allow other participants to ask a question respectively.

Question comes from the line of Chris Schott from Jpmorgan. Your line is now open you may ask your question.

Thanks, so much for the question.

Operator: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the hash key. We will limit two questions for each participant to allow other participants to ask their questions respectively. The first question comes in from Chris Schott from J.P. Morgan. Your line is now open, and you may ask a question.

On I guess the first one on your Deneke sales could you just provide maybe a bit more context around <unk> I'm trying to get a sense of it sounds like it's kind of dipping in <unk> and then kind of recovering from there. So just maybe a little bit more color of how much of a step down should we think about relative to <unk> as we think about some of the inventory dynamics et cetera that you mentioned and I said.

One follow up from there.

Thanks, Chris.

Mr. Thompson do you want to take that question about the dynamics of Q1.

Christopher Thomas Schott: Great, thanks so much for the question. On the first one about Udenica sales, can you just provide maybe a bit more context around 1Q? I'm just trying to get a sense of, yeah, it sounds like it's kind of dipping in 1Q and then kind of recovering from there. So maybe a little bit more color on how much of a step down we should think about relative to 4Q as we think about some of the inventory dynamics, etc., that you mentioned. And I just have one follow-up from there.

Yes.

Yes, sure Thanks, Denny and thanks for your question Chris.

Thank you.

In <unk>, we're going to really see a sort of a.

Im shift here as <unk>.

As Covid recede and the population gets vaccinated.

We're going to see is a dynamic where.

We have this huge opportunity with neulasta on trial.

<unk> got a stable share on the mid 50% range, which represents a huge reservoir of opportunity for us and I think that.

Dennis M. Lanfear: Thanks, Chris. Mr. Thompson, do you want to take that question about the dynamics of Q1? I'd like to make a few points.

We'll start to see that evolving, especially when we go from Q1 to Q2.

Chris Thompson: Yeah, sure. Thanks, Denny, and thanks for your question, Chris.

But.

Given some of the searches that we saw in Q1 with Covid.

Chris Thompson: You know, I think, in one cue, we're going to really see a sort of a paradigm shift here as COVID recedes and the population gets vaccinated. I think what we're going to see is a dynamic where, you know, we have this huge opportunity with New LASTA OnPro. They've got a stable share in the mid 50% range, which represents a huge reservoir of opportunity for us. And I think that, you know, we'll start to see that evolving, especially if we go from Q1 to Q2.

Think that.

That will definitely have somewhat of an impact on.

On Q1 for us keep in mind debt.

When we think about on pro it's just it's just a big relative.

Relative to.

What's actually happening in the marketplace now we're sort of relegated.

Two really trading share with each other the biosimilars.

As it relates to inventory, we feel confident that inventory is going to return to normal state and already has so we're in good shape. There I don't know if that answered your question.

Thanks, Mr. Thompson I would just make one further remark Chris Schott is that last year between Covid waves.

Chris Thompson: But, you know, given some of the surges that we saw in Q1 with COVID, I think that that will definitely have somewhat of an impact on Q1 for us. But, keep in mind that, when we think about OnPro, it's just a big thing relative to what's actually happening in the marketplace now. We're sort of relegated to really trading shares with each other, the biosimilars. As it relates to inventory, we feel confident that inventory is going to return to its normal state. It already has, so we're in good shape there.

Saw on pro recede significantly between those waves and so we're quite confident that as the vaccinations progress.

And people get back to normal that we will see this happened and once again, perhaps with the greater rapidity.

Think that the incentives are already priced into the market for that and we believe that we are very well positioned to capitalize on that as soon as COVID-19 fades.

Dennis M. Lanfear: Thanks, Mr. Thompson. I would just make one further remark to Chris Schott, that last year between COVID waves, we saw OnPro recede significantly between those waves. And so we are quite confident, then, as the vaccinations progress and people get back to normal, that we will see this happen once again, perhaps with greater rapidity. We think that the incentives are already priced into the market for that. And we believe that we are very well positioned to capitalize on that as soon as COVID fades. Great And just my opinion

And just my follow up question was when do we think about the PD. One your initial indications of fairly small one you've got some obviously much larger ones to follow so I guess, how should we be thinking about that that ramp up that first indication and how indicative or not will this initial ramp be for future larger indications I'm trying to get a sense of basically is this first indication of that.

US much about the potential for kind of a new PD one on the market or do we really need to see the bigger indications before we get a better sense of how this is going to play in the marketplace versus some of the existing kind of entrenched competition.

Christopher Thomas Schott: My follow-up question was, when we think about the PD-1, your initial indication is a fairly small one. You've got some, obviously, much larger ones to follow. So I guess, how should we be thinking about the ramp for that first indication, and how indicative or not will this initial ramp be for future larger indications? I'm just trying to get a sense of, basically, is this first indication going to tell us much about the potential for kind of a new PD-1 in the market, or do we really need to see the bigger indications before we get a better sense of how this is going to play out?

Great question Chris.

I believe that we were going to do very well with our execution around that the first indication one of the things that go here is just excellent that as you've seen in the Biosimilar business is a very holistic execution around Medicare part B space, the buy and Bill space.

We will be the team that has the labeled indication for this orphan it will be small, but I think that will do very very well with it more importantly, we will start to be able to to socialize our brand into the market and we'll be talking to the payers to providers the physicians and nurses I think it's a great entry point for us as we go.

Dennis M. Lanfear: Great question, Chris. I believe that we are going to do very well with our execution around the first indication. One of the things that Coherus is just excellent at, as you've seen in the biosimilar business, is a very holistic execution around the Medicare Part B space, the buy and build space. We will be the team that has the labeled indication for this orphan. It will be small, but I think that we'll do very, very well with it.

Forward. So I think we'll wrap up very quickly there with the PD one but of course, that's going to be very exciting as we start to add some additional indications. We think that there is going to be probably at least one additional indication filed per year, we prioritize the largest ones such as lung. So I'd, just say stay tuned to that but we're fairly excited that we're going to do very well on this mark.

Dennis M. Lanfear: More importantly, we'll start to socialize our brand into the market. We'll be talking to the payers, the providers, the physicians, and the nurses. I think it's a great entry point for us as we go forward. So I think we'll ramp up very quickly there with the PD-1. But, of course, what's going to be very exciting is when we start to add some additional indications. We think that there's probably going to be at least one additional indication filed per year.

Right.

Thank you. Your next question comes from the line of Mike <unk> from Citi. Your line is now open you may ask your question.

Great. Thanks for taking my question and before I begin I mean, thank you very much yet John funds flow.

Judging on DVS. Thank you very much for that.

So maybe.

Starting with the.

Thank you Danica.

Look if you look at last few quarters the market shifts with you Danica has been relatively stable in this 2022% range, but other biosimilars have been slowly chipping away, but not like they are not going to <unk>. So you mentioned need to probably do you do on pro.

Operator: Thank you. The next question comes from the line of Marek Ben-Sal from Citi. Your line is now open. You may ask your question.

Balaji V. Prasad: Starting with Udenica, if you look across, if you look in the last few quarters, the market share for Udenica has been relatively stable in this 20-22% range, while other biosimilars have been slowly chipping away, but not like they're not growing either. So you mentioned it is probably due to OnPro. So from that background, how do you think about Can, after COVID, what gives you confidence that you can probably take more share from OnPro? And having an OnBody injector, do you think it is necessary to take more share from OnPro at this point?

From that background, how do you think about.

Growing here and.

Ken after Covid, what gives you confidence that you can probably take more share from on Peru.

And having no.

On body injector do you think it is early to take.

Take more share from on pool at this point.

Yes.

I'll take that one first and I'll, let Mr. Thompson backfill.

Debt.

You take a look at 2020 Mohit there was the ebb and flow of Covid across right. There was the first wave in Q2, I think we that showed some very good numbers. There on the face of Q2, we began to come back and then Covid came back.

Dennis M. Lanfear: I'll take that one first and I'll let Mr. Thompson fill in the details. I think that if you take a look at 2020 Mohit, there was the ebb and flow of COVID across, right? There was the first wave in Q2. I think that showed some very good numbers there in the face of Q2. We began to come back, and COVID came back.

As we've spoken before Covid put the market in a bit of I'd say stasis very hard for new entrants to make substantial gains you saw that with some of our competitors easier for the entrenched competitor Amgen to leverage the inherent.

Dennis M. Lanfear: As we've spoken before, COVID put the market in a bit of, I'd say, stasis. Very hard for new entrants to make substantial gains. You saw that with some of our competitors. Easier for the entrenched competitor Amgen to leverage the inherent market advantage of the on-pro system in that market.

Market advantage of the on pro system in that market. So all in we consider that we did a pretty good job maintaining share through 2020 in the face of that.

We didn't have to endure quite the same price cuts that the innovator did to maintain share now going forward in 2021, it sort of depends on how fast things go with the vaccinations and so on most of the stuff that we've seen is that things are looking better certainly now through Q1, I would expect it to do.

Dennis M. Lanfear: So all in all, we consider that we did a pretty good job maintaining our share through 2020 in the face of that. And so on. Most of the stuff we've seen is that things are looking better, certainly now through Q1. I would expect that to continue in Q2. So, you know, perhaps an uptick in Q2 and on through the end of the year. We expect the quarters to grow successively as we go on through 2021. But we think the market, while I wouldn't say it's going to come to us, we think we'll do very well in this market in 2021 in terms of moving forward. I think we're poised.

In Q2, so perhaps an uptick in Q2 and on through the end of the year, we expect the quarters to grow successfully as we go on.

Through 2021, but we think the market well I wouldn't say, it's going to come to US. We think we'll do very well on this market in 2021 in terms of moving forward I think we're poised and ready.

Dennis M. Lanfear: Guys. Guys.

Got it.

Chris Thompson: Chris, do you have a comment?

Good.

Chris do you have comment yes.

Chris Thompson: Yeah, I was going to say, you know, I agree with everything that Denny says, but, you know, if you think about it, we've already run the experiment, you know, Q1, Q2 of last year, you could see that we were making significant inroads on ProShare because it really is a better value proposition for the providers. We anticipate as the vaccination program expands, as the COVID spikes recede, that we're going to pick up where we left off and make significant inroads there. You know, we are the biosimilar market leader at 21% share, and we're pretty excited about the fact that we're going to expand upon that market leadership position.

Yes, I was going to say I agree with everything that Denny said.

But you know if you think about it we've already brought on ran the experiment Q1 Q2 of last year, you could see that we were making significant inroads on on pro share because it really is a better value proposition for the providers.

We anticipate as the vaccination program expands as the Covid spikes recede.

Going to pick up where we left off and make significant inroads in there.

We are the Biosimilar market leader at 21% share and we're pretty excited about the fact that we're going to expand upon that market leadership position I will just give you an anecdote as well.

Chris Thompson: Just to give you an anecdote as well, there are, you know, several large institutions in the Midwest, and I'm out there talking to customers all the time, and these institutions had made virtually a total conversion to Udenica early last year. Obviously, with the spikes in COVID and all the problems we had with COVID and the convenience of OnPro, they were forced to actually go to more OnPro. We lost our share there.

There are several large.

Institutions in the Midwest and I'm out there talking to customers all the time and these institutions had made virtually a total conversion to <unk>.

Early last year.

Year and.

Obviously with the spikes in Covid and all the problems, we had with Covid and it can be in sub bond from.

They were forced to actually go to more on probably lost share there and I'm happy to report right now in speaking with these customers that they've already started to move back to your debt again, a pretty large way to me that's sort of the Canary in the coal mine, that's indicative of what's going to happen with accounts across the United States because.

Chris Thompson: And I'm happy to report right now that, in speaking with these customers, they've already started to move back to Udenica in a pretty large way. To me, that's sort of the canary in the coal mine. That's indicative of what's going to happen with accounts across the United States because it's such a compelling value proposition for our customers. You know, OnPro is going to go from being, you know, an expensive necessity when COVID was around to really being an expensive convenience. And most folks now, given the economic state they're in, whether it's a clinic or a hospital, they've got to be looking at the numbers, and Udenica provides the best numbers for these customers.

It's such a compelling value proposition for our customers.

On <unk> is going to go from a very.

Expense of necessity when COVID-19 was around two.

To really inexpensive convenient and most folks now given the economic states, they're in whether it's a clinic or a hospital they've got to be looking at the economics and <unk> provides the best economics for these customers.

Chris Thompson: Thanks, Bohin.

Thanks Mohit.

Operator: Thank you. The next question comes from the line of Salim Syed from Mizzou. Your line is now open. You may ask a question.

Thank you. Your next question comes from the line of Salim Sayed from Mizuho. Your line is now open you may ask a question.

Salim Qader Syed: Great, good afternoon guys, and I'd like to add my thanks to John and congratulations to McDavid for stepping into the role. A couple from me, Denny, if I can, and then just one, maybe housekeeping, if that's possible.

Great. Good afternoon, guys and I'd like to add my thanks to John and congrats to David for stepping into the role.

Couple from me, Danny if I can and then this one maybe maybe housekeeping if that's possible.

Dennis M. Lanfear: Denny, this one high-level question for the biosimilars industry, I'm curious, you know, one of the things that I've been sort of thinking about in this business, what was the point when you were, you know, you looked at, you know, you had two years of biosimilar launches with Udenica, what was the point where you decided that, you know, going after a novel strategy was the more, you know, the thing that Well, I'm just curious what the point was to break away hard and say that a novel is kind of like the way to go.

Denny just one high level question for the Biosimilars industry.

I'm curious you know one of the things that I've been sort of thinking about win on this business. What was the point you know when you were you looked at.

Two years of Biosimilar launch with you Danica.

What's the point, where you decided that you know going after a novel strategy was the more you know the thing that you wanted to break away pretty hard from being a pure play biosimilar switch some investors thought with plus four the story I'm just curious what the point was to break away hard and say novel is kind of like the way to go.

Oh.

Dennis M. Lanfear: That's question one. And then two, just on the CFO transition, just curious, McDavid, if there's anything that we should expect differently as you transition into the role? And then, if I can sneak in a quick housekeeping one that some folks have asked on the ILEA.

That's question one.

Then two just on the CFO transition just curious Mick David if theres anything that we should expect differently.

As you transition into the role.

And then if I can sneak in a quick housekeeping one that some folks have asked on the are you on the I V.

Dennis M. Lanfear: This will be three...

This will be three for you.

Dennis M. Lanfear: Okay, okay; I get it.

Okay. Okay, I can start with you.

Dennis M. Lanfear: I don't believe there was a breaking point with respect to strategy. The company was founded with the mission of delivering savings to the healthcare system and greater access to patients. That was, that was really the key issue. We always felt very, very strongly about that. All my co-founders that came out of Amgen and Genentech and had worked in those shops, you know, they all felt that this was the moral high ground and really the right thing to do.

Okay, Alright, So let me let me handle the first one so on.

I don't believe there was a breaking point with respect to strategy that the company was founded with a mission of delivering.

Savings to the healthcare system and greater access to the patients that was that was really the key issue. We always felt very very strongly about that all my co founders that came out of Amgen and genentech.

Ed.

Worked in those shops, they all felt that this was.

The moral high ground and really the right thing to do and I think that as early as 2016, we began to look at PD ones in the evolving landscape and so on and how they look.

Dennis M. Lanfear: And I think that as early as 2016, you know, we began to look at PD1s and the evolving landscape and so on, and how they looked. Our view is that, you know, there is substantial value to be delivered to the healthcare system. There's good to be done by delivering on PD-1 because they're becoming ubiquitous across immuno-oncology.

Our view is that you know that.

There is substantial value to be delivered to the health care system, there's good to be done by delivering on a PD one because.

They are becoming ubiquitous across immuno oncology, so we see very very broad utilization.

Dennis M. Lanfear: So, we see very, very broad utilization for our product because we can deliver a value proposition like we have with Udenica, right? We have a very high quality product, and a very broad label. We've got a great partner who has invested heavily. You know, I think that the market is really going to welcome us with open arms. We're going to start small, and we're going to expand, but you'll see continued growth. But, you know, I don't really think that there was sort of a religious dedication to biosimilars.

Our product because we can deliver our value proposition as we have with your deneke right. We have a very high quality product very broad label, we've got a great partner has invested heavily.

I think that really the market is going to welcome us with open arms, we're gonna start small and we're going to expand but you'll see continued growth, but I don't really think that.

There was sort of.

Our religious dedication to biosimilars.

Dennis M. Lanfear: You know, biosimilars are a way to deliver value, and that's what we saw. And so, if we can leverage the capabilities across the organization, you know, protein science, ClinReg expertise, and primarily our commercial capabilities, which are, you know, quite strong, as you know, we think that's a way to go in terms of increasing shareholder value. And it really wasn't any more complex than that.

Similar as a way to deliver value and that's what we saw and so if we can leverage the capabilities across the organization protein Science Clinton Reg expertise and primarily our commercial capabilities, which are quite strong as you know.

We think thats the way to go in terms of increasing shareholder value and it really wasn't any more complex than that I'll, let Mick David speak for himself as far as how he's going to followers and the large footsteps left by J D. I think David yes.

McDavid Stilwell: I'll let McDavid speak for himself as far as how he's going to follow in the large footsteps left by JV.

McDavid Stilwell: As Denny said, we are very grateful that Jean created such a strong accounting and finance function at Coherus, and I am very much looking forward to working closely with all of those team members and with our external partners, such as EY and others. So I'm very pleased with the state of that organization and really looking forward to being a part of that team. I'm also going to be spending a lot of time with investors and analysts as our story evolves.

Yes.

Denny said, we're very grateful.

John created such a strong accounting and finance function Echo Harris and I am very much looking forward to working closely with with all of those team members.

And with our external partners, such as <unk> and others. So.

I'm very pleased with the state of that organization.

And really looking forward to on.

Being a part of that team.

I'm going to be spending a lot of time also with investors and analysts as our as our story evolves and it is evolving very quickly in 2021 and connecting investors to the promise of the story is the potential approvals come along with Biosimilars, Lucentis and Avastin Humira and also.

McDavid Stilwell: And it's evolving very quickly in 2021 and connecting investors to the promise of the story as potential approvals come along with biosimilars, Lucentis, Avastin, Humira, and also as potential approvals come through the Toripalumab program, which will begin to stack up, we believe, very quickly. And so there's a great deal of value that we believe we're creating with this growing and diversified portfolio of product And I want to spend a lot of time with investors and analysts and make sure that they understand that value. So that's a big part of my job.

Potential approvals come through the Torrey pines on that program, which will begin to stack up we believe very quickly and so theres a great deal of value that we believe we're creating with with this growing and diversified portfolio of product candidates moving through and I want to spend a lot of time with investors and analysts to make sure that they understand that.

Value. So that's a big part of my job.

Dennis M. Lanfear: Yeah, Salim, the other point that I would give you is that since the announcement that we were entering the immuno-oncology and PD-1 space, we've had very positive, supportive outreach from our customer base in oncology. I think they're highly receptive. You know, we've had some very large teams talk to us, and we've had some conversations with them, of course. So I think that the environment is really, really ready for this sort of an approach. You know, it's worked very well in biosimilars, and I think we're going to do quite well in the PD-1 space, frankly. I think we are the right solution at the right time.

So, leaving the other point that I would give you is since the announcement that we were entering the immuno oncology PD one space.

Had very positive supportive outreach.

Our customer base in oncology.

They are highly receptive we've had some very large teams talk to us and we've had some conversations with them of course, so I think that the environment is really really ready for this this sort of an approach. It's worked very well on biosimilars and I think we're going to do quite well on the PD one space frankly, I think we're the right solution at the right.

Time.

Operator: The next question comes from the line of Balaji Prasad from Barclays. Your line is now open, and you may ask a question.

Next question comes from the line of from Raj Prasad from Barclays. Your line is now open you may ask a question.

Balaji V. Prasad: Hi, good afternoon. Thanks for taking the questions. Firstly again, Jami, all the best, and it was great speaking to you over the past couple of years and coming to...

Hi, good afternoon, thanks for taking the question.

Firstly again on the day all the best on Great speech on over the past couple of years.

And coming back.

Yes.

Operator: Yep.

Yes, Scott coming to the questions.

Balaji V. Prasad: Coming to the questions, one line in your statement caught my interest, where you said that your R&D spending will increase on additional presentations of Eurenica, so I just want to understand, I would imagine that this is the on-body device, and I want to compare this with what you had said earlier recently, that you would not be investing further dollars in biosimilars, so I take that this is a one-off exception. Second, I would like to understand your degree of confidence in the gating factors for each of the three BLAs that you plan to submit this year, Lucente, Sebastian, and Torrey Pallimab. I think we'll probably need some assurance on that front. I'll stop you with these two. Thanks.

One lining his statement.

Caught my interest, where you said that your R&D spending will increase on.

Additional presentations on <unk> any color.

So just wanted to understand I would imagine that this is the on body.

Device and I wanted to compare that with what you have said earlier recently that you will not be.

Investing further dollars on Biosimilars, so I take the days on one off exception.

And I would like to understand your degree of confidence on the gating factors for each of the three BLE is that you plan to submit this year lucentis or avastin on Panama I think.

Probably they will.

Need some assurance on that front.

I'll start the other day thanks.

Dennis M. Lanfear: Great. Well, thank you for that, Balaji.

Great well. Thank you for that policy. So we have previously reflected to you on calls that we're pleased with our progress and on body and.

Dennis M. Lanfear: So we have previously reported to you on calls that were pleased with our progress, and I think you can safely assume that means that we have made investments, and those are going to show up in the financial statements, and we're going to spend a little money to make progress there. But I don't think that that's quite the same as, for example, committing significant funds to phase three of an ILEA product or things like that. So I don't see any incongruity with respect to line extensions or additional presentations of Udenica at all with that.

I think you can safely assume that means that we have made investments and those are going to show up in the financial statements.

We're going to spend a little money to make progress there.

I don't think that.

That's quite the same as for example, committing.

Significant funds to phase III.

And I lead product or things like that right. So I don't see any.

Incongruity with respect to line extensions or additional presentations of identical.

At all with that I think I think that's something that we've pursued and its consistent that their products approved and so on now with.

Dennis M. Lanfear: I think, first of all, I'll talk about the Tauropalumab BLA, and then I'll let Vince Anastetti, our Chief Operating Officer, say a few more comments with these others. With respect to the Tauropalumab BLA, I think that we're in very good shape. Our partner, Jun-Chi, has had several conversations going back over a year with FDA on that indication, the nasal pharyngeal indication. You know, they've got breakthrough status, you know, it's an orphan, and so on. So I think they've had a lot of conversations.

Spect to the.

The confidence in the BLA is.

I think first of all I'll talk about the the tort Palomar BLA and then I'll I'll, let Vince on the study our Chief operating Officer say, a few more comments with these others with respect to the Torah Palmette BLA I think that we're in very good shape. Our partner <unk> has had several conversations going back over a year with FDA on that indication.

<unk> nasal pharyngeal indication.

They've got breakthrough status it's.

In orphan and so on so I think they've had a lot of conversations that got very solid data of course, they've been approved in China.

Dennis M. Lanfear: They've got very solid data, of course. They've been approved in China. The follow-on first line has been submitted in China. So I think that's buttoned up pretty well.

The follow on first line has been submitted in China. So I think that's buttoned up pretty well with respect to the BLA I think the issue. There now will be in order to get approval they'll have to get an inspection of facilities in that facility that product of course is made in China. So the.

Dennis M. Lanfear: With respect to the BLA, I think the issue there now will be, in order to get approval, they'll have to get an inspection of facilities, and that facility, that product, of course, is made in China. So the FDA is going to have to, you know, find a way to get that facility inspection done in a timely fashion. It's an unmet need, and so on.

The FDA is going to have to find a way to get that facility inspection done on a timely fashion, it's none met need and so on so we're hopeful that they'll sort that out and of course you know the FDA has just really been focused on.

Dennis M. Lanfear: So we're hopeful that they'll sort that out. And of course, you know, the FDA has just really been focused on, you know, the J&J vaccine, and a number of things. So we have a lot of empathy for the FDA's work. I can't believe how hard they're working and how well they're doing. But overall, I think they'll get this and sort it out.

On the J&J vaccine a number of things. So we have we have a lot of empathy for the Fda's work I can't believe how hard they're working on how well theyre doing so but overall I think they'll get to this and sorted out now the other BLA or coming of course that the 14 20 BLA for Humira has been filed and accepted I'll, let Vince talk about that.

Dennis M. Lanfear: Now...

Vince Anacetti: So, the other BLAs are coming. Of course, the 1420 BLA for Humira has been filed and accepted. I'll let Vince talk about that. The Lucentis BLA is upcoming, and Biowac is going to file that. Vince, could you comment on those two for us, starting with 1420?

The Lucentis BLA.

His upcoming and biotech is going to file that and I'll, let Vince could you comment on those two for us starting with 14 'twenty, yes. Thank you Denny.

Vince Anacetti: Yeah, thank you, Denny. So with our Humira biosimilar CHS1420, as we announced, the FDA accepted that for review, which means they found everything within the BLA in order and all of the necessary information there. We also have had a number of meetings over the last year with the FDA reviewing our development program, both on the clinical and the manufacturing analytical side. We received a lot of guidance from the FDA. They gave us a very good roadmap.

With our Humira Biosimilar CHS $14 20, as we announced the FDA accepted that for review, which means they found everything within the BLA in.

In order and all of the necessary information there we are.

Also have had a number of meetings over the last year with the FDA reviewing our development program both on the clinical and the manufacturing analytical side, we received a lot of guidance from the FDA.

Gave us very good roadmap, so where we are receiving questions from them now and there I would characterize them as routine.

Vince Anacetti: So we are receiving questions from them now, and I would characterize them as routine, and we expect the review to go well, I would say, and hopefully, we will get a positive decision from the FDA in December on our action date. In regard to the BioEck-Lucentis biosimilar, in a similar fashion, BioEck has been working with the FDA very closely to resolve all of the prior issues with their prior submission prior to their decision to withdraw.

We expect the review to go well.

Well I would say and hopefully you get a positive decision from the FDA in December on our action day.

In regard to the bio WAC Lucentis biosimilar.

In a similar fashion biotech has been working with the FDA very closely.

To resolve all of the prior issues with their prior submission prior.

Prior to their decision to withdraw and are in a very recent meeting in Q1 reviewing all of the work that was done to remediate those deficiencies.

Vince Anacetti: And in a very recent meeting in Q1, reviewing all of the work that was done to remediate those deficiencies, FDA felt that the work was done in an acceptable way and agreed that BioEck could go forward and submit that BLA for review, which we see as a very positive sign. So that will go in mid-year, and we expect that review to go well, too.

The FDA felt that the work was done in an acceptable way and agree to it.

Agreed biotech could go forward and submit the BLA.

For review, which we see as a very positive sign so that will go in in mid year, and we expect that review to go well too.

Dennis M. Lanfear: Does that help with those questions about the PLAs, Balaji?

Does that help on those questions with the BLA is buzzing.

Yeah.

Operator: Okay, the question has been withdrawn. And next, we have Jason Gerberry from Bank of America. Your line is now open. You may ask a question.

Question on the husband in Israel and next question, we have Jason <unk> from Bank of America. Your line is now open you may ask your question.

Jason Matthew Gerberry: Hey guys, thank you for taking my questions, and I also want to extend my gratitude to JV for all the help over the years and best of luck in future endeavors. So my question, Denny, by my estimation, there are four PD-1s coming to the U.S. market for lung cancer in the next two years under the BLA pathway. This is a tumor that accounts for about 50% of Kutruda's revenues. So when we look at these molecules, they have comparable PFS data when you compare across histology, which, to my understanding, is the best way to do a cross-trial comparison and not run into the issue of post-progression therapies.

Hey, guys. Thank you for taking my questions and I also want to extend my gratitude to JV for all of that all the help.

Over the years and best of luck in future endeavors. So my question.

Danny.

By my estimation, there is for PD ones coming to the U S market for lung cancer in the next two years under the BLA pathway.

This is a tumor that accounts for about 50% of contributors revenues. So when we look at these molecules. They have comparable PFS data when you compare aircrafts histology, which to my understanding is the best way to do a cross trial comparison and not run into the issue of like post progression therapies. So.

Jason Matthew Gerberry: So my question ultimately is, how do you think this is gonna impact the U.S. lung cancer market? It's a big, obviously, component of it all. These are large-cap companies that have shown a historical willingness to compete on price in big categories on a net price basis, and I noticed on your last call that cancer might be an underappreciated category for price sensitivity. So just kind of curious if you can give your overarching thoughts on that topic. Thanks.

My question ultimately how do you think this is going to impact the U S lung cancer market, it's a big.

Obviously, a component of it all.

These are large cap companies that have shown on historical willingness to compete on price and big categories on a net price basis and on.

I noticed on your last call you mentioned that.

Cancer might be an underappreciated category for price sensitivity. So just kind of curious if you can get your overarching thoughts on that topic. Thanks.

Dennis M. Lanfear: Well, thanks a lot. Thanks a lot for the questions.

Thanks, a lot. Thanks, a lot for the question.

Dennis M. Lanfear: I think that the overarching short answer is that I think that we have demonstrated in the biosimilar business that we are very fierce and competent competitors who don't resort to the price lever to drive share. We understand our customers' needs. We understand the value proposition. We spent two years before we entered the launch of that market just understanding what the customers needed in fashioning the value proposition, establishing the relationships, and then we executed on it. And I think you're going to see the very same thing here.

I think that the <unk>.

Overarching short answer is that I think that we have demonstrated in the biosimilar business that we are first we are very fierce and competent competitors, who don't resort to the price lever to drive share right. We understand our customers' needs we understand the value proposition. We spent two years before.

We entered that launched in that market just understanding what the customers needed in fashioning the value proposition, establishing the relationships and then we executed on it I think youre going to see the very same thing here you won't see US go into this market and really understand what the needs of all the constituencies, our Medicare part b and deliver on that.

Dennis M. Lanfear: You're going to see us go into this market and really understand what the needs of all the constituencies are in Medicare Part B and deliver on those in a very holistic fashion. And I think that bodes well for us. I'm not sure what the size of the impact is on these other places and how much they need and so on.

Those in a very holistic fashion.

Fashion, and I think that bodes well for us.

I'm not sure what the.

<unk> impact as these other places and how much they need and so on.

Dennis M. Lanfear: But I think that it's a market that is exactly matched to our commercial capabilities, and furthermore, I think that we are sized accordingly to deliver on it. We're certainly going to beef up our MSL teams and our reimbursement teams and things like that. But structurally, our organization is very well put together to scale for the challenge. So I think that we're fairly optimistic, and I think that we'll be fine. I'll give you a little more detail on that once we get a little further into Lung.

I think that.

It's a market that is exactly matched to our commercial capabilities and further I think that we are sized accordingly to deliver on it we're certainly going to bump up our MSL teams in our reimbursement teams and things like that but structurally our organization is very well put together.

Scale for the challenge so I think that we're fairly optimistic and.

That will be fine I'll give you a little more detail on that once we get a little further into long, we actually get the filing in and as we proceed with our market research on other calls we will be very open with you on how we're going to talk about it but I think that will do great.

Dennis M. Lanfear: We'll actually get the filing in. And as we proceed with our market research on other calls, we'll be very open with you about how we want to talk about it. But I think that we'll do great. And we're not afraid. We're obviously not afraid of competition. We're absolute, fierce, competent competitors.

And we're not afraid, we're obviously not afraid of competition, where absolute first competent competitors.

Jason Matthew Gerberry: Okay, so basically, we wait till the file's in before we get a better sense of what the customers really need and what that unmet need you'll be solving for is?

Got it okay. So basically wait until the files and before we get a better sense of what the customers really need and what that unmet need you'll be solving for us.

Dennis M. Lanfear: Yeah, I don't think there's a, I don't know if there's an unmet need. I wouldn't say that, but I would say there may be an unmet total solution, right, that these folks want. I will only take you back to the comments that Chris Thompson and I made, that when we announced that we had done this transaction and we were moving into the PD-1 space, we had an outpouring of support from various quarters of oncology, the clinical oncology teams, and others, large organizations, who welcomed us, you know, to this particular market segment. So, I think these folks are very happy that we're coming.

Yes.

I don't think there is a I don't know if there is an unmet need I wouldn't say that but I would say there may be a unmet total solution right that these folks want I would only take you back to the comments that Chris Thompson I made is that when we announced that we had done this transaction, we're moving PD one space.

Good day outpouring of support from various quarters of the oncology of the clinical oncology teams on others large organizations, who welcomed us.

To this particular market segment. So I think these folks are very happy that we're coming.

Chris Thompson: Hey Denny, it's Chris. If I could add, prior to, you know, signing the deal with Jun-Chi, we were doing a lot of outreach, trying to understand what providers, what physicians we were looking for as it relates to PD-1. And in doing so, they were very excited that we were entering this market. I mean, in oncology, folks buy from people they trust and who they know. And we've established a great relationship with oncologists as it relates to Udenica, and we just got a sense that there is a lot of excitement about our entering this market.

Yeah, Denny, it's Chris if I could add.

Prior to.

Signing the deal with <unk>.

We were doing a lot of outreach.

I'm trying to understand.

What providers, what physicians were looking for as it relates to PD, one and in doing so.

They were very excited that we were entering this market.

And oncology folks.

Buy from whom they trust and who they know and we've established a great relationship.

With oncologists as it relates to you Danica.

And.

We just got a sense that there is a lot of excitement from.

Are entering this market.

Dennis M. Lanfear: Yeah, the other point that I would make is that, you know, we're proficient at competing in markets where there is not a significant amount of therapeutic differentiation, right? So this is our wheelhouse. You can't get any more than biosimilars with, you know, in terms of lack of therapeutic differentiation. As you pointed out, you can look at PFS across these various products, and you see very, very similar readouts, very similar mechanisms of action, and so on. So I think this will work well for us.

Yes, the other point that I would make is that we have were proficient at competing in markets.

Where there is not a significant amount of therapeutic differentiation right. So this is our wheelhouse you can't get any more than the biosimilars.

In terms of the lack of therapeutic differentiation as you pointed out.

You can look at PFS across these various products and you see very very similar readouts very similar mechanism of action. So on so I think this plays well for our strength.

Operator: Thank you. We have the next question. It comes on the line from Greg Gilbert from Tourist Securities. Your line is now open. You may ask a question.

Thank you. The next question comes from the line of Gregg Gilbert from two Mr. Ken and Keith. Your line is now open you may ask a question.

Greg Gilbert: Great, thanks. Two, I'll ask them up front.

Great. Thanks.

Two I'll ask them upfront on my first question is about Humira I'm curious, how transferable and applicable you think that your Deneke example, as to Humira given the different sort of channels on incentives in the system, maybe talk about difference.

Greg Gilbert: My first question is about Humera. I'm curious how transferable and applicable you think the Udenica example is to Humera, given the different sort of channels and incentives in the system. Maybe talk about differences and out-of-pocket at the patient level. I'm not so sure exactly what saving the system money means in one case versus the other, as the middlemen seem to welcome new companies because they can make more money on that, but curious about the out-of-pocket cost at the patient level between those two.

Out of pocket at the patient level I'm, not so sure exactly what saving the system money means in one case versus the other assets.

The middleman seem to welcome new companies because they can make more money on that but curious about the out of pocket at the patient level between those two and then Denny I was intrigued by your comments on the last call about.

Greg Gilbert: And then, Denny, I was intrigued by your comments on the last call about the potential for biosimilars to Keytruda not to show up in 2028 and that it may be harder than people think to get there. If you were wrong about that, and there are biosimilars to Keytruda in 2028, is that contemplated in how you're working on your development strategy, and does your development strategy include co-formulations? As it appears, Merck is driving a lot in that direction. Thank you.

The potential for Biosimilars to Keytruda not to show up in 2028, and then it may be harder than people think to get there.

If you were wrong about that and there are biosimilars to keytruda in 2028.

Is that contemplated on how youre working on your development strategy and does your development strategy include co formulations as it appears Merck is driving a lot in that direction. Thank you.

Dennis M. Lanfear: Yeah, I think those are two great questions. So, first of all... Under the circumstance that biosimilars to Keytruda show up in, you know, 28 or 29, four or five years earlier than we have, I think that's fine. I think that these PD-1s really need to be put together, as you point out, in combinations. This is the whole reason why we have the combinations available to us, the Tidgets, the engineered IL-2s, and others, from our agreement with Jun Shi.

Yes, I think those are two great questions. So first of all.

Under the circumstance that biosimilars to true that show up in 2008 or 2009.

Five years earlier than we have.

I think that's fine I think that these.

PD ones really need to be put together as you point out with combination. This is all the reason why we have the combinations available to us the tickets the engineered IL twos on others from our agreement with June shape and this is also why we saved them on this call that we are open to combinations.

Dennis M. Lanfear: And this is also why we've stated on this call that we are open to combinations with other parties who come to us, either institutions or small companies and others, who want to do studies with us on combinations. So we think in the period from 2025 forward, it's going to be less an issue of monotherapy than it will be an issue of combinations. We think that we have a very, very good PD-1 here that we have partnered with Jun Shi, and we think that we'll be very successful with that. So the base therapy is PD-1.

With other parties, who come to us either institutions or small companies and others, who want to do studies with US combination. So we think in the period from 2025 forward, it's going to be less.

Hugh of monotherapy.

Will be an issue of combinations, we think that we have a very very good PD one here.

We have.

<unk> with Gmg and.

And we think that will be very successful with that so the base therapy is PD one yeah on the Biosimilars might show up but I think that you have to have the combinations and we've got a very robust pipeline of combos coming and we welcome others.

Dennis M. Lanfear: Yeah, biosimilars might show up, but I think that you have to have combinations, and we've got a very robust pipeline of combos coming, and we welcome others. With respect to Humira and the co-pays and with the patients and so on, you know, I don't want to say too much because we're really in a position to work out our strategy, and I don't want to show our strategic cards very much with Humira. But I would make a couple of points.

With respect to Humira and the co pays and with the patients and so on.

I don't want to say too much because we're really in a position of working forward our strategy and I don't want to show our strategic cards very much with tomorrow, but I would make a couple of points. The first point that I would make is that the the presumption has been for some time amongst some folks that you wouldn't get.

Dennis M. Lanfear: The first point that I would make is that the presumption has been for some time among some folks that you wouldn't get switched patients, that patients that are stable on Humira would stay on Humira until they naturally go on to another therapy or whatever. And then your market penetration would be largely slowed by the need for fresh starts. We believe that large, high-control payers, by the time this comes around in 2023, will embrace putting biosimilars high up on the formulary. However, they may have to step through that.

Switch patients that Ah patients that stable on Humira would stay on humira until they naturally go on to another therapy or whatever and then your market penetration would be largely slowed by the need for fresh starts.

We believe that large high control payers.

By the time this comes around in 'twenty, three will embrace putting biosimilars high up on the formulary. They may have to step through that we think that they will probably forced switches in some case because there is just so much savings and I think theres disintermediation available there and I think that we're going.

Dennis M. Lanfear: We think that they will probably force switches in some cases because there is just so much savings, and I think there's disintermediation available there. And I think that we're going to be prepared to serve very large parts of the market with supply guarantees, a high-quality product, a state-of-the-art auto-injector, and a non-sting formulation. We've looked at all this, and I think that we are going to do very well in this space because of that. Again, I think the way to be successful in these businesses is to talk to your customers to understand their needs.

Be prepared to serve very large parts of the market.

With supply guarantees high quality product on a state of the art auto injector, a non staying formulation we've looked at all of this.

Think that we're going to do very well in this space because of that.

Again, I think the way to be successful in these businesses is to talk to your customers to understand their needs and so we are in that process now and understanding.

Dennis M. Lanfear: And so we are in that process now and understanding just what we have to do vis-à-vis the payers and, of course, the patients and the providers that do that. But I think that we've put a stake in the ground here, and we think we can take 10% of the market share at least. We're going to gear up for that, our manufacturing, and so on. We think this is going to be a great market, and there are significant savings to be delivered in the Umairah side of the business.

What we have to do vis vis the payers and of course, the patients and the providers to do that but I think that we've put a stake in the ground here that we think we can take 10% market share at least.

On a gear up for that our manufacturing and so on so we think this is going to be a great market and there is a significant savings to be delivered in the humira side of the business.

Yeah.

Thank you we have your next question comes from the line of Chunky I don't know from Cowen <unk> Company. Your line is now open you may ask your questions.

Operator: Thank you. We have the next question that comes from the line of joy for you. Your line is now open. You may ask a question.

unknown: Hey guys, thank you so much for taking my question. So, as it relates to Los Santos and PD1, if you think about the opportunity and your expertise, Udenica likely has somewhat different institutional engagement versus Salesforce and payer effort requirements. Could you characterize for us how the promotional effort and payer engagement might differ or be similar with Los Santos and the PD1 assets? And then, on the Junshi collaboration, we noticed that the majority of clinical trials they're running are in China. Would it be possible to use the data from these trials for FDA approvals in the U.S., or would you have to run smaller U.S.-based trials, especially for those larger indications?

Hey, guys. Thank you so much for taking my question. So I guess as it relates to our centers and PD. One if you think about the opportunity and your expertise identical likely has.

Somewhat different institution or engagement versus sales force and payer accurate requirements could you characterize for us how the promotional effort and payer engagement might differ or be similar with the sensors and the PD one assets.

And then on the JV.

Rishi collaboration.

Is that the majority of clinical trials, they're running on China based would it be possible to use the data from these trials for FDA approvals in the U S or would you have to run smaller U S based trials, especially for those larger indications.

Dennis M. Lanfear: Okay, um, that's a let me unpack a little bit of that. Let me take the last one first.

Okay.

Let me unpack a little bit of that let me let me take the last one first so I think when you considered trials done anywhere in the world and the issue is less.

Dennis M. Lanfear: So I think when you consider trials done anywhere in the world, and the issue is less histology-driven genetics, which is sometimes the case, but what you really want to watch out for, number one, is do you have the same standard of care, right? And then do you have a relevant patient population that is transferable? So Jun-Shi has taken a very good look at this.

Of histology, driven genetics, which is sometimes the case, but what you really want to watch out for number. One is do you have the same standard of care right.

And then do you have a relevant patient population that is transferrable. So June she has taken a very good look at this we feel that long MPC esophageal urethral triple negative breast all these indications transfer very very well and we think that those pivotal clinical trials will transfer the United States.

Dennis M. Lanfear: We feel that lung, NPC, esophageal, urethral, triple negative breast, all these indications transfer very, very well, and we think that those pivotal clinical trials will transfer to the United States. Now, Jun-Shi and myself will spend our time through the rest of 2021 here, talking to the FDA about what the registration strategies are on an indication-by-indication basis and see, but I would not assume that there's additional clinical work that needs to be done specifically with things like NPC is fine. But if you do run into some histology-driven genetics, then you may have to do something else.

Now, Jim Sheehan ourselves going to spend our time through the rest of 2000.

'twenty one here talking to the FDA about what the registration strategies are on an indication by indication basis, and see but I would not assume that theres additional clinical work that needs to be done specifically with things like NPC is fine, but if you do run into some histology driven genetics and you may have to do.

Do something else, but by and large I think that these are high quality trials that are transferable.

Dennis M. Lanfear: But by and large, I think that these are high-quality trials that are transferable. Now, to your other question with respect to the Lucentis Biosimilar and then, secondly, the PD-1 Biosimilar. I'll first take the PD-1 Biosimilar, and I'll part that out with respect to Medicare Part B, and then talk a little bit, and I'll let Chris Thompson talk about Lucentis. So we think that the PD-1 Biosimilar will really scale our existing oncology sales force, call points, GPO contracts, relationships, payer strategy, all those things will line up very, very well with the PD-1.

Now to your other question with respect to.

Look the Lucentis Biosimilar and then secondly, the PD one biosimilar.

I'll first take the PD, one biosimilar and I'll parse that out with respect to Medicare part B, and then talk a little bit I'll, let I'll, let Chris Thompson and talk about the Lucentis. So we think that the PD one biosimilar.

It will really scale, our existing oncology sales force call points GPO contracts.

Relationships payer strategy all of those things will line up very very well with the PD. One so we see that as a very synergistic product portfolio mix and that's why we're optimistic about that and we've heard from all of these parties. So far as we've gone forward so excellent excellent fit that.

Dennis M. Lanfear: So we see that as a very synergistic product portfolio mix, and that's why we're optimistic about that, and we've heard from all of these parties so far as we've gone forward. So, excellent, you know, the PD-1 with Udenica into that market. Chris, do you want to talk a little bit about the Lucentis market structure, Medicare Part B, buy and bill, and some of the subtleties there

PD, one with you deneke into that market, Chris do you want to talk a little bit about the the lucentis market structure Medicare.

B buy and bill and some of the subtleties there.

Dennis M. Lanfear: Yeah.

Yes, thanks Denny.

Chris Thompson: Yeah, thanks, Denny. You know, obviously, we've been very successful being the market leader with Udenica, being that it's a Part B drug. And our capabilities around that are, you know, recognized by our customers as being outstanding and understanding that market, understanding the importance of ASB, and understanding their business models and how they generate revenue within their clinics. We think all of this expertise is transferable. As a matter of fact, two days ago, we were part of presenting to a focus group of retinal specialists and talking with them and trying to understand their business models. They're very excited about Coherus entering with a biosimilar in the future.

Obviously, we've been very successful being the market leader with you've done it.

Being that it's a part b drug.

And our capabilities around that are recognized by our customers as being outstanding and understanding that market understanding the importance of ASB understanding their business models on on how they generate revenue within their clinics. We think all of this expertise is transferable.

Lucentis as a matter of fact two days ago.

We're part of presenting to a focus group retinal specialists.

In talking with them and trying to understand their business models, they're very excited about.

Coheres entering with a biosimilar in the future.

Chris Thompson: We did get some, you know, good points from them on things we want to consider in our value proposition for that specialty. And we pride ourselves on being able to really shape great value for whatever specialty we enter. But, you know, if you think about the skills that are necessary to be successful here, we have those. We have that experience in Part B. And the same will apply to our payer team who works on the medical benefits side of the commercial side, right? It's the same business as Udenica, and we have those relationships in place, and we believe that, you know, they're very anxious to have that type of competition in the marketplace.

We did get some.

Good points from them on things you want to consider in our value proposition with that specialty and we pride ourselves on being able to really shape.

Great value for four.

<unk>.

Whatever specialty we enter but if you think about the skills that are necessary to be successful here. We have those we have that experience in part B and.

On the same will relate to our payer team.

<unk> works with on the medical benefit side on the commercial side right.

It's the same same business as you Danica and we have those relationships in place and we believe that.

They are very anxious to have that type of competition in the marketplace.

Chris Thompson: Hey Chris, just one more thing. Can you comment on the applicability of Coherus Complete in our reimbursement efforts and how well those transfer?

Hey, Chris just one more thing.

Can you comment on the applicability of Cohere is complete and our reimbursement efforts.

All of those transfer.

Chris Thompson: Yeah, I'm glad you asked that, Denny. One of the things that struck a chord the other night when we were talking with these end healthcare professionals, retinal specialists, was the fact that we have Coherus Complete, which is our hub for patient services, which provides everything from co-pay assistance, to indigent patient care, to benefit verification, to prior authorizations. You know, when you put that whole package together, it works nicely into the workflow of a retinal specialist's office and takes some of the burden away from them to have to manually do all this.

Yes, I'm glad you asked that Denny.

One of the things that struck a chord the other night when we were talking with these.

And health care professionals retinal specialists.

The fact that.

We have co here is complete which is our hub for our patient services, which provides everything from co pay assistance.

To indigent patient care to benefit verification to prior authorizations.

Put that whole package together it works nicely.

Into the workflow of a <unk>.

And on specialist office and take some of the burden away from them to have to manually do all of this.

Chris Thompson: We've actually streamlined, most recently, our benefits, verifications, and prior authorizations so they can do it electronically. So this really takes a lot of time, you know, a burden away from their office staff and helps them, you know, be more efficient. You know, these customers are always very excited about that. Workflow is important.

We've actually.

Streamline most recently our benefits verifications.

And prior authorizations. So they can do it electronically. So this really takes a lot of time.

Burden away from their office staff and helps them.

To be more efficient.

These customers are always very excited about that workflow is important.

Chris Thompson: Okay, thank you.

Okay. Thank you.

Operator: Thank you. The next question comes from the line of Douglas Tsao from HC Wainwright. Your line is now open. You may ask a question.

Thank you next question comes from the line of Douglas Channel from H C. Wainwright. Your line is now open you may ask a question.

Douglas Dylan Tsao: I just want to wish JV well and join everybody else in saying how great it's been working with him. You know, in terms of the Jun-Chi partnership, I was just curious, on the last call, you did make some comments in terms of some of the characteristics of the PD-1 that interested you. I was just wondering if you were in a position to provide any color in terms of the TIGIT as well as the IL-2 in terms of how those molecules might be, you know, maybe differentiated in the wrong way, but if there are any unique characteristics that make you think they're particularly appealing.

Hi, good afternoon, and just wanted to wish J P well on.

John on everybody else and saying how great it's been working with them.

Denny.

Is the <unk> partnership I was just curious on the last call you did make some comments in terms of some of the characteristics of the PD. One day interested you I was just wondering if you are in position to provide any color in terms of the ticket as well as the IL two.

In terms of how those molecules might be on.

Maybe differentiate is the wrong way, but if theyre on a unique characteristics debt debt that.

Dennis M. Lanfear: Thanks for the question, Doug. I'm going to hedge a little bit on this because we have not yet cleared Hartscott-Rodino, and we'll probably have a little bit more to say about this as additional data is generated later in the year. But I think that there's precedent in the literature. If you look at the TIGITs and their synergy, for example, in the lung with PD1s, or if you look at the engineered IL-2s and so forth, you can dig out a lot of data along these lines. I would point you to that, or if you want us to refer you to some of those publications, I can have one of my team members take that on, and McDavid can point that out to you.

That make you think that particularly appealing.

Thanks for the questions.

I'm going to hedge a little bit on this because we have not yet cleared Hart Scott Rodino, and we'll probably have a little bit more to say about this is.

Just on data is generated later in the year, but I think that there is precedence.

In the literature.

Look at the tickets and Theyre synergy for example in lung with PD ones or if you look at the engineered IL twos and so forth you can dig out some a lot of data along these lines I would I would point you to that or if you want us to refer you to some of those publications I can have one of my team members.

Take that on and Mcdavid can point that to you.

Dennis M. Lanfear: But I think there are a plethora of complementary combination products in development at Jun-Chi, and I think particularly what's attractive about the transaction as structured is that our expenditures are limited to $25 million per product per year for any of these products. So that gives us a fair amount of P&L predictability as we go forward, particularly over the next couple of years while we're watching the dollars. And I think that really sort of puts us in a position where we can participate in global development programs with these assets, and still, though, we have cost control, which, of course, is attractive to us and our investors.

I think there is a.

A plethora of complementary combination products in development at June <unk>, and I think particularly.

What's attractive about the transaction is structured is that our expenditures are limited to $25 million per product per year for any of these products. So that gives us.

A fair amount of P&L predictability as we go forward, particularly over the next couple of years, while we're watching the dollars and I think that really puts us in a position where we can participate in global development programs with these assets.

And still though we have cost control, which of course is attractive to us and our investors. So I kind of have to stop there but.

Dennis M. Lanfear: So I'll kind of have to stop there. But on the next call, I think we'll have a little more to say to you about that. And in the interim, we'll be happy to forward some scientific literature to you.

Next call I think we'll have a little more to say to you about that and in the interim we'll be happy to forward some scientific literature off to you.

Okay that'd be really helpful. And then just as a.

Dennis M. Lanfear: Okay, that'd be really helpful. And then, just as a follow-up to the Lucentis opportunity, at what point, now that we're nearing DLA submission, should we think about any sort of increase in SG&A or the commercial infrastructure ahead of that launch? And will it necessarily be noticeable, or is this something that you can accomplish pretty efficiently and so should not be too impactful? Especially in the context of the hope that we can start to see Udenica growing again next year. Thank you.

A follow up in terms of the Lucentis.

Opportunity.

At what point now that we're nearing BLA submission should be think about any sort of increase in SG&A with the commercial infrastructure ahead of that launch.

Will it be necessarily.

Notable or is this something that you can can accomplish pretty efficiently. So it should be.

Not too impactful on especially in the context of the hope that we can start to see <unk> growing again next year. Thank you.

Dennis M. Lanfear: Yeah, thanks for that one. I would say it's not too impactful. I think you used the right terms.

Yes, thanks for that one.

I would say not too impactful I think you used the right term.

We have significant investments already and are.

Dennis M. Lanfear: We have significant investments already in our information technology infrastructure, dashboard systems, readouts. We'll certainly need a marketing manager here and there to focus on things. We haven't really decided on what the footprint needs to be, but we've talked before about the concentration of accounts, the number of people. Maybe it's 20 to 25 folks, something along that order.

Information technology infrastructure.

<unk> systems Readouts, we will certainly need a marketing manager here and there to focus on things, we haven't really decided on what the footprint needs to be but we've talked before about the concentration of accounts. The number of people, maybe it's 20 to 25 folks something along that order, but we haven't really.

Dennis M. Lanfear: But we haven't really come down on how exactly we need to do that. I will say that if we get the filing in around here, mid-year or so, as we've said, we'll give you a little more color on that. But in any case, we don't think there's going to be a substantial ramp up on the expense line for this. And as you heard from Chris Thompson, we've already started outreach to the community in ophthalmology, understanding what the value proposition needs to look like. And I think fashioning the value proposition is the most important thing right now, so we're focused there.

Come down on how exactly we need to do that.

We'll say that if we get the filing in mid round here mid year. So as we said, we'll give you a little more color on that but in any case, we don't think theres going to be a substantial ramp up.

On the expense line for this and as you heard from Chris Thompson, We've already started outreach to the community ophthalmology understanding what the value proposition needs to look like and I think fashioning that value proposition is day.

Most important thing right now so were focused there.

Operator: Last question comes from the line at Balaji Prasad from Marquess. Your line is now open. You may ask a question.

Last question comes from the line at the larger price.

On that from Barclays. Your line is now open you may ask your question.

Balaji V. Prasad: Thank you. Sorry.

Yes.

Thank you sorry.

Balaji V. Prasad: I just wanted to get back to you, Danny, when you were asking me if you had answered the questions. The third BLA that I mentioned was one that I asked him and wanted to get your sense of confidence on that. Incidentally, I found the responses on the other two very useful. Thank you.

I just wanted to get back to Denny when you're asking me if you had answered the questions.

The third BLA that I wanted to that I mentioned was avastin and wanted to get your sense of.

Confidence on that incidentally I found these responses on that until late useful. Thank you.

Dennis M. Lanfear: Oh, thanks for that. I think that we disclosed today that we're underway with the three-way PK study. You know, we got slowed down on that one a little bit last year with COVID. We did that deal, then as soon as Chinese New Year was over, COVID hit, everything kind of ground to a halt, the FDA pivoted, and so that slowed things down. I think it's fair to say that things were running along fairly well at this time, making good progress on the trial.

Oh, Thanks for that I think that we disclosed today that we are underway with a three way PK study.

Got slowed down on that one a little bit last year with Covid. We did that deal then as soon as Chinese new year was over you know COVID-19 hit everything kind of ground to a halt the FTA pivoted and so that slowed things up I think it's fair to say that things are running along fairly well at this time, making good progress on the trial. So we will give you update on the next call on that one when we have a little more clarity.

Dennis M. Lanfear: So we'll give you an update on the next call on that one when we have a little more clarity, but that's about where it is. But, you know, that was one of these things last year where we, you know, it was just COVID impact on that one. But it's clipping along, you know, fairly well now.

But that's about where it is but that was one of these things last year where are we.

It was as Covid, just COVID-19 impact on that one, but it's it's clipping are on fairly well now.

Dennis M. Lanfear: Alright, thank you.

Thank you.

Alright, thank you.

Operator: No further questions at this time. I will now turn the call over to Mr. McDavid Stilwell for any closing remarks.

Yes.

No further question at this time I will now turn the call over to Mr. David <unk> for any closing remarks.

McDavid Stilwell: Thank you everybody for joining us on the call today. We look forward to speaking to you again in the near future. Thanks, guys.

Thank you everybody.

Body for joining us on the call today look forward to speaking to you again in the near future.

Thanks, guys Bye bye.

Operator: Thank you.

Thank you.

Operator: Thank you, ladies and gentlemen. That concludes today's conference call. Thank you all for participating. You may now disconnect.

Thank you ladies and gentlemen that concludes today's conference call. Thank you all for participating you may now disconnect.

unknown: BF-WATCH TV 2021

Okay.

Okay.

[music].

The Bulletproof Executive, 2013