Q3 2020 Coherus BioSciences Inc Earnings Call
[music].
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences 2020 3rd Quarter Earnings Conference. My name is Ashley, and I will be your conference operator for the call today.
Ladies and gentlemen, thank you for standing by and welcome to the Coherus Biosciences Senn Delaney third quarter earnings Conference call. My name is actually now gone screen top leaders for the call today is.
Operator: As a reminder, this conference call is being recorded. I would now like to turn the call over to McDavid Stilwell, Executive Vice President of Corporate Development, Investor Relations, and Financial Strategy at Coherus. Thank you.
As a reminder, this conference call is being recorded.
I would now like to turn the call over to Mcdavid Stilwell Executive Vice President of corporate development.
That's really changed and financial strategy at <unk>. Please go ahead.
McDavid Stilwell: Good afternoon, everyone, and thank you for joining us. After the close of market today, we issued a press release with our third quarter financial results. This release can be found on the Coherus BioSciences website. This call includes forward-looking statements regarding Coherus's current expectations. These statements include, but are not limited to, statements relating to the effects of the evolving COVID-19 pandemic, our plans and expectations regarding our ongoing commercialization of Udenica, the Product Candidate Pipeline, Product Development Plans, Financial Projections, and the 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. 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.
Thank you.
Good afternoon, everyone and thank you for joining us.
McDavid Stilwell: 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. Please also note that the non-GAAP financial measures included in our press release should be used to help you understand Coherus's business performance and should not be a substitute for your review of our GAAP financial measures. The gap to non-gap reconciliations are also provided in the earnings press release.
Dennis M. Lanfear: Joining me for today's call are Dennis Lanfear, Coherus's Chief Executive Officer, Jean Viray, Chief Financial Officer, Chris Thompson, Executive Vice President of Sales, and Dinesh Piranduri, Executive Vice President of Commercial Strategy and Operations. On today's call, we'll first review our results for the third quarter of 2020 and provide commentary on the Peg PhilGrafton market. We'll then update you on our company financials or pipeline progress, and lastly, close with a few comments about Coherus's growth strategy. And I'll now turn the call over to Denny.
Well then update you on our company financials, our pipeline progress and lastly, close with a few comments about coherent this growth strategy and I'll now turn the call over to Denny.
Dennis M. Lanfear: Thanks, McDavid, and thanks to everyone for joining us on the call today. In September, Coherus celebrated its 10-year anniversary, and I am thrilled by what we have accomplished at this milestone. Coherus is a fully integrated company with competencies in research, development, and commercialization, and we are successfully fulfilling our mission to deliver value to patients by providing them with access to cost-effective drugs that can have a major impact on their lives. Moreover, our Udenica business is generating significant cash flow, which will fund pipeline investments to expand our addressable market opportunity from $4 billion to about $30 billion over our five-year planning period. With respect to our third quarter 2020 business results, Our diluted earnings per share is $0.33 on a GAAP basis and $0.47 on a non-GET basis.
Thanks, Miss David and thanks to everyone for joining us on the call today.
In September cohere celebrated its 10 year anniversary and I am thrilled about what we have accomplished at this milestone.
<unk> was a fully integrated company with competencies in research development and commercialization and we have successfully fulfilling our mission to deliver value to patients by providing them with access to cost effective drugs, because I have a major impact on their lives.
Moreover are you deneke business is generating significant cash flow, which will fund pipeline investments to expand our addressable market opportunity from 4 billion to about 30 billion over our five year planning period.
With respect to our third quarter of 2020 business results.
Are diluted earnings per share was 33, and a gap basis 40.
47 on a non-GAAP basis.
Dennis M. Lanfear: We end the quarter with cash, cash equivalents, and short-term investments of $503 million, above the half billion mark for the first time in the company's history. Udenica's net product revenue was $114 million in the third quarter. Our commercial team continues to execute and to demonstrate a remarkable ability to adapt to the volatility of the COVID-19 environment. However, compared to the prior quarter, the overall Pagel-Grafton market declined by
We ended the quarter with cash cash equivalents and short term investments a $503 million above the half billion Mark for the first time in the company's history.
<unk> net product revenue was $114 million in the third quarter.
Our commercial team continues to execute it the demonstrated remarkable ability to adapt to the volatility of the COVID-19 environments.
Compared to the prior quarter, the overall pegfilgrastim market declined by 7%.
Dennis M. Lanfear: Udenica X-Factory unit sales rose by 2%, and our market share increased from 20% to 22%. As we approach two years of experience commercializing Udenica, I'd like to reflect on the question that many of you were asking us at launch: can a small, first-launch, pure-play biosimilar company compete with much larger, entrenched originators and established biosimilar competitors?
You Deneke X factory unit sales rose by 2% in our market share increased from 20% to 22%.
As we approached two years of experience commercializing you deneke I'd like to reflect on the question that many of you were asking us at launch.
Can a small first launch pure play about similar company compete with much larger entrenched originators and established Biosimilar competitors.
Dennis M. Lanfear: With Udenica achieving 20% exit market share after the first year and approaching a market share range of 23 to 24% as we close out year two, I believe we have answered that question affirmatively. We have demonstrated our ability to be a trusted and reliable partner, delivering value to providers and payers. Two years in, the key question has shifted.
With your delicate achieving 20% exit market share after the first year and approaching the market share range of 23% to 24% as we close out here too.
I believe we have answered that question affirmatively.
We have demonstrated our ability to be a trusted and liebel partner delivering value to providers and payers.
Two years in the key question has shifted.
Dennis M. Lanfear: We are now asked, what is the shape of the life cycle curve for biosimilars and, Are your revenues sustainable? While we are not at this time providing formal revenue guidance for 2021, a task made difficult by COVID, we'll share with you what we know and what we believe about the three key drivers of future revenue growth. The Peg Philgraston market growth has been unusually volatile this year, shifting from 3% growth in the second quarter to 7% decline in the third quarter.
We are now ask what is the shape of the life cycle curve with Biosimilars and our.
<unk> revenue sustainable.
While we are not at this time, providing formal revenue guidance for 2021, a task made difficult by Covid will share with you what we know and what we believe about three key drivers a future revenue growth.
Firstly, the Pegfilgrastim market growth has been unusually volatile this year shifting from 3% growth in the second quarter to 7% decline in the third quarter.
Dennis M. Lanfear: We believe that over the longer term, peggable grass and unit sales will return to their historical low single-digit growth. In the near term, while new cancer patient diagnoses and referrals may fluctuate as the COVID pandemic impacts the health care system, these patients will ultimately be diagnosed and treated, albeit at a more advanced stage. Secondly, while we anticipate continued price pressure in the market, we expect the rate of price erosion to slow over time. As any competitor's base of business grows, incremental price concessions become increasingly costly, both directly and in terms of ASP decline. Thirdly, we remain highly confident that our value proposition, Choice without Compromise, will drive continued share gains for Udenica at the expense of the originator in both its formats, which still remains a significant opportunity. The pressure in the healthcare system to find meaningful cost savings that do not compromise patient outcomes has never been greater and will continue for the future.
We believe that over the longer term Pegfilgrastim unit sales will return to the historical low single digit growth rate.
In the near term, while new cancer patient diagnoses and referrals may fluctuate as the Covid pandemic impacts the healthcare system. These patients will ultimately be diagnosed and treated.
Albeit at a more advanced stage.
Secondly.
While we anticipate continued price pressure in the market, we expect the rate of price erosion to slow over time.
As any competitors base of business grows incremental price concessions become increasingly costly.
Both directly and in terms of ESP decline.
Thirdly.
We remain highly confident that our value proposition choice without compromise will drive continued share gains for Ya deneke at the expense of the originator in both its formats.
Which still remains a significant opportunity.
The pressure in the healthcare system to find meaningful cost savings that do not compromise patient outcomes has never been greater and will continue.
Chris Thompson: Taken together, we believe that these three key drivers, market growth, price, and share, and overall product value, will nut out to a base case scenario of relatively sustainable revenues through 2021, subject to the caveats of COVID uncertainty. I'll now turn the call over to Chris Thompson, our Executive Vice President of Sales, for a more in-depth discussion of the Udenica business trends. Thanks, Denny.
Future.
Taken together, we believe that these three key drivers market growth price and share an overall product value, while not out will not out to a base case scenario Ah relatively sustainable revenues through 2021 subject to the caveat of Covid uncertainty.
I will now turn the call over to Chris Thompson, Our executive Vice President of sales for a more in depth discussion of the deneke business trends Chris.
Thanks, Jenny resilience and excellence in execution and become a hallmark of coheres.
Chris Thompson: Resilience and excellence in execution have become a hallmark of Coherus. In the third quarter, customer engagement interactions increased over the previous quarter, and we've been proud to see our efforts continue to pay off as we deliver for our customers even within the context of the COVID-19 pandemic. Our team's execution translated into continued strong performance with stable to rising market share for Udentica in recent quarters. With respect to Coherus Market Share, there's always a quarter-to-quarter admin flow across all segments. 340B, and non-340B hospitals and clinics.
In the third quarter customer engagement interactions increase over the previous quarter and we've been proud to see our efforts continue to pay off as we're delivering for our customers even within the context of the COVID-19 pandemic.
Our team's execution translated into continued strong performance with stable to rising market share for Ya deneke in in recent quarters.
With respect to coheres market share, there's always a quarter to quarter ebb and flow across all segments 340 be non 340 be hospitals and clinics.
Chris Thompson: 340B as a share of our business was down in the second quarter and has returned to the third quarter. A core strategy for Udenica is to pursue growth in all segments, balancing our efforts across all sectors. According to IQVIA data, our share gains in the third quarter appear to have come from both the last to on-pro and pre-filled syringe formats. Pre-COVID, Encore market share had fallen to almost 50%
340, B as a share of our business was down in the second quarter and has returned to the third quarter.
A core strategy for you deneke as to pursue growth in all segments balancing our efforts across them.
According to <unk> data our share gains in the third quarter appear to have come from both you lost on pro and pre filled syringe formats.
Pre covid ontko market share had fallen to almost 50%.
Chris Thompson: In the early months of the COVID crisis, ODDPRO recaptured some of that lost share. However, as practices have adapted to the pandemic, on-pro use has trended back down toward pre-CoVID levels. Overall, we expect biosimilars to continue to gain unit share against the originator with about 70% of the market still available for conversion. We believe our publicly reported ASP is the best barometer of pricing trends in the market for the 12 months through the third quarter of 2020. The Udenica ASP has declined by approximately 4% per quarter.
In the early months of the Covid crisis on pro recaptured some of that loss share. However.
However, as practices have adapted to the pandemic on pro use as trended back down toward pre covid levels.
Overall, we expect Biosimilars to continue to gain units share against the originator with about 70% of the market is still available for conversion.
We believe are publicly reported hsp is the best barometer of pricing trends in the market.
For the 12 months through the third quarter of 2020.
You Deneke Aspie has declined by approximately 4% per quarter.
Chris Thompson: In the current quarter, the Udenica ASP decline is less than that of Amgen or Mylan, consistent with our strategy of selling based on our branded value proposition. We will continue to execute our Udenica Commercial Strategy with a disciplined and balanced approach. We continue to enjoy healthy market access for Udentica with regional and national payers.
And the current quarter U Deneke AFC decline is less than that of Amgen form island.
Consistent with our strategy of selling based on our branded value proposition.
We will continue to execute are you deneke commercial strategy with a disciplined and balanced approach.
We continue to enjoy healthy market access for Ya deneke with regional and national payers.
Chris Thompson: In two recent examples, we are delighted that Udentica will hold a co-preferred position alongside Nulasta for Anthem Commercial and Medicare Advantage plans covering approximately 30 million lives, and that Udetica will retain parity and preferred positioning with prime health plans covering approximately 28 million lives. Looking ahead, we expect the Pegfield-Grafton market to resume the historical trend of low single-digit annual market growth, albeit with some quarter-to-quarter volatility. We also expect Udenica to continue to grow unit share, and we plan to maintain pricing dis- I'll now turn the call over to our CFO, John Marek, for a review of the quarter's financials. Thank you, Chris.
And two recent examples we are delighted that you're deneke will hold co preferred position alongside Neulasta for and some commercial and Medicare advantage plants, covering approximately 30 million lives and that you deneke will retain parity and preferred positioning with prime health plans covering.
Leave 28 million lives.
Looking ahead, we expect the pegfilgrastim market to resume that historical trend of low single digit annual pegfilgrastim market growth, albeit with some quarter to quarter volatility.
We also expect you deneke to continue to grow units here and we plan to maintain pricing disciplined.
I will now turn the call over to our CFO, John Ray for review of the quarter's financials.
Thank you Chris details of our third quarter financials are included in our press release and in our form 10-Q. So I'll Cook just today on the review of highlights for the third quarter of 2020.
John Marek: Details of our third quarter financials are included in our press release and in our Form 10-Q, so I'll focus today on a review of highlights for the third quarter of 2020. This quarter, we have had solid execution with Udenica, and we continue to make investments to advance our pipeline. Our confidence in our financial position and the growth potential of our business remains strong. Net product revenue was $114 million, with non-GAAP net income of $40 million and diluted non-GAAP earnings per share of $0.47. Net revenue for the 3rd Quarter of 2020, 2019 was $112 million with a non-gap net income of $56 million and diluted non-gap earnings per share of $0.74. Wholesale inventory was stable compared to the prior quarter. Research and development expenses for the third quarter of 2020 were $39 million, compared to $22 million for the same period in 2019.
This quarter, we have had a solid execution with you Denny count and we continued to make investments to advance how pipeline.
Ah confidence in our financial position and the growth potential of our business remains strong.
Net product revenue was $114 million with non-GAAP net income of 40 million and deputy non-GAAP earnings per share of 47.
Net revenue for third quarter of 2019 was 112 million with a non-GAAP net income of 56 million and diluted non-GAAP earnings per share of 74 cents.
I'll sell inventory was table compared to require quarter.
Research and development expenses for the third quarter of 2020, where $39 million compared to $22 million for the same period in 2019.
John Marek: Selling general and administrative expenses for the third quarter of 2020 and the same period in 2019 were $32 million. We anticipate that R&D and SG&A expenses combined for the full fiscal year 2020 will come in at the low end of our stated range of $285 million to $310 million. Looking ahead for the fourth quarter, we are projecting relative SG&A expense stability, while R&D expense will increase moderately as we continue our work advancing our pipeline. Our operating activities continue to generate cash, and we are pleased to have ended the quarter with $503 million in cash, cash equivalents, and short-term investments, up $47 million from the end of the second quarter. I'll now turn it back to Denny.
Aiming general <unk> expenses from the third quarter of 2020, and the same period in 2019 $32 million.
Dennis M. Lanfear: Thank you, John. I'd like to provide a few updates and highlights regarding our pipeline of biosimilar product candidates. We've made very good progress across our pipeline, particularly on programs where Coherus is sponsored with the FDA. Our Vast and Biosimilar, which we in-licensed from InnoVent, will further expand our oncology franchise and leverage our commercial infrastructure. As the U.S. sponsor of the product, we are continuing to work with Inovant towards Coherus's expected BLA filing next year with the FDA. Precise timing of our filing is dependent on the scheduling and outcome of required interactions with the FDA, the completion of a three-way pharmacokinetic study, as well as the completion of analytical similarity exercises. Moving to ophthalmology, we have two product candidates in the pipeline addressing an aggregate $6 billion U.S. opportunity, a Lucentis biosimilar and an ILEA biosimilar. We in-licensed the Lucentis biosimilar last year from BioX.
Dennis M. Lanfear: BioWAC is the BLA sponsor, and they are actively proceeding with the FDA-required activities to resubmit the BLA. Manufacturing work to refile the BLA has recently been completed. BioEc has informed us that the required pre-filing meetings with FDA are now expected to take place in early 2021. Our CHS 2020 biosimilar candidate, Twelia, continues to make progress.
<unk> required activities to resubmit the BLA.
Manufacturing work to re file to be La has recently been completed.
Biotech has informed us that the required pre filing meetings with FDA are now expected to take place in early 2021.
Our CHS 2020, Biosimilar candidate to Eylea continues to make progress.
Dennis M. Lanfear: We project the initiation of a Phase III clinical trial in 2021, with a potential commercial launch in 2025, if approved. Lastly, with respect to immunology and CHS1420, our internally developed Humira biosimilar candidate, we plan to submit the BLA by year-end, consistent with our prior guidance. We have made additional progress on our manufacturing strategy for this product as we prepare for a large-scale launch anticipated on or after July 1, 2023, as well as our launch strategy. We expect this will be an $18 billion market in the U.S. by the time of our launch, and we believe we can gain a significant share. This 2023 launch is an important focus for the company, and we expect to do well. Before taking questions, let me offer you a few closing thoughts. Udenica has been the benchmark for a high-performing biosimilar.
We project the initiation of a phase III clinical trial in 2021 with a potential commercial launch in 2025 if approved.
Lastly, with respect to immunology and CHS 14 20.
Our internally developed Humira Biosimilar candidate, we plan to submit to be laid by year end consistent with our prior guidance.
We have made additional progress on our manufacturing strategy for this product as we prepare for a large scale launch anticipated on or after July onest 2023, as well as our launch strategy.
We expect this will be an $18 billion market in the us by the time of our launch and we believe we can gain significant share.
This 2023 launches an important focus for the company and we expect to do well.
Before taking questions. Let me offer you a few closing thoughts.
Your deneke has been the benchmark of a high performing Biosimilar and we believe the strong you deneke launch demonstrates our competitive competency and pre sales is a success with our future products.
Dennis M. Lanfear: And we believe the strong Udentica launch demonstrates our competitive competence and presages success with our future products. We remain focused on continued commercial execution in today's environment, while also advancing our pipeline. As the assets in our pipeline progress towards commercialization over the next four years, we anticipate our addressable market will grow from $4 billion today to about $30 billion in 2025.
We remain focused on continued commercial execution in today's environment, while also advancing our pipeline.
As the assets in our pipeline progress towards commercialization over the next four years, we anticipate our addressable market will grow from $4 billion today to about $30 billion in 2025.
Dennis M. Lanfear: Our durable cash flow and strong balance sheet enable us to consider attractive new investments which would leverage our capabilities in research, development, and commercialization, creating significant shareholder value. We are actively pursuing multiple opportunities but remain highly disciplined with respect to future licensing deals and investments. I look forward to providing additional updates to you on our progress. Operator, this concludes our prepared remarks. Please open the line for questions. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone. If your question has been answered, or you wish to remove yourself from the queue, please press the pound key. Your first question comes from the line of Mohit Bansal with Citigroup. Your line is now open.
Operator: Great. Thanks for taking my question. Unknown Executive, Ashwani Verma, McDavid Stilwell, Paul Reider, Rosh Dias, Bhavin Patel, Jami Taylor, Douglas Tsao, Salim Syed, Robyn Karnauskas, Michael Nedelcovych, Colleen Karnauskas, Bryan McMichael, Coherus BioSciences Inc., Hey, Mohit. Thank you very much for your I'll let McDavid Stilwell take that one for you. Okay, McDavid?
The the bed Miss fix or is there any other dynamic that is being out here.
Thanks, Thank you very much for your question.
McDavid Stilwell: Without question, COVID continues to have an influence. It caused a contraction of the overall PEG footgrasp market in the third quarter. The other factor contributing to the quarter-to-quarter change in revenue includes a shift in the mix, with a higher portion of revenue coming through 340B hospitals. Danny, you mentioned that going forward, you expect the price erosion to slow down here. And if I, if you can comment on that as well, you mentioned that the price decline has been about 4% or so per quarter for the last 12 months. That's like 15% per year. So when you say slow down, you're talking about single-digit growth eventually, or maybe it's like 3-4%.
I'll, let Mick David still well take that one for Ya mcdavid.
Thank you.
Without question Covid continues to have an influence.
Uh-huh covid caused a contraction of the overall tech progressive market in the third quarter.
The other factor contributing to the quarter to quarter change in revenue includes a shift in the mix with a higher portion of revenue coming through 340 B hospitals.
Got it got it so.
That explains it again, so Danny you mentioned that.
Going forward, you expect the price erosion too slow down here and if I.
Mcnair if you can comment on that is that you mentioned that the price decline has been about 40% or so but quieter for last 12 months that take 15%, but yet so when you say slowed down you were talking about single digit eventually or maybe dislike T. 4%. How should we think about it was 15% animal is pretty high actually.
McDavid Stilwell: How, how, how should we think about this because 15% annual is pretty high, I think. Yeah. Yeah. Yeah.
She'll get pricing.
McDavid Stilwell: I'm sorry, Mohit, is your question about the price decline will be going forward, or... Yeah, you said it would slow down, but when you say slow down, what number are you talking about? I don't want a specific number, but I mean, what are we thinking, is it more like a mid-single digit, or is it still going to be a high-single-digit kind of decline going forward for I would advise you that it is difficult for us to control pricing because that's controlled by the other competitors in the market as we go forward. Secondarily, what I would say is that we probably have the strongest ASP price discipline in the market. As you heard, our ASP price discipline was better than that of both Mylan and Amgen. I'm unable to predict the actual decline in prices.
I'm sorry.
Sure is your question.
What the cough decline will be going forward or yeah. So you said it was slow down, but when you say slowed down what what nobody that I.
I don't want a specific number but I mean, how old are you thinking what is it like more like mid single digit or is it still going to be a high single digit kind of decline going forward for pricing.
I would offer you that it is difficult for us to control pricing that's controlled by the other competitors in the market as we go forward secondarily, what I would say is that we maintain probably the strongest ESP price discipline in the market as you heard resp price discipline.
Was better than that of both Mylan and Amgen I'm unable to predict an actual decline in prices that that is dependent of course upon competitor behavior, but I would further point out though that.
McDavid Stilwell: That is dependent, of course, upon competitor behavior. But I would further point out, though, that in the actual Medicare Part B segment, there is a bit of self-regulation in terms of price cutting because there is less value to distribute among the whole value chain in those particular parts of the value chain. Overall, I think over time you will see a gradual decline in the price change and more stabilization as you go forward. I'll just say what it is, though, but I think we've done a very good job maintaining our price in the face of competition. That makes sense. Thank you, Danny.
In the actual Medicare part B segment.
There is a bit of self regulation in terms of price cutting because there is less value to distribute among the whole value chain there with those particular.
Parts of the value chain. So overall I think over time, you will see a gradual decline.
And the price change and more stabilization as you go forward.
God, how does that day, what it is though but I think we've done a very good job maintaining our price in the face of competition.
That makes sense. Thank you Danny Thank you ma'am.
McDavid Stilwell: Thank you, McDavid. Thanks, Marek. Your next question comes from the line of Balaji Prasad with Barclays. Hi, good evening, and thanks for taking the questions.
Thanks.
Your next question comes from the line.
Exactly.
Okay.
Balaji V. Prasad: Firstly, could we start with an update on the filing, please? While I'm cognizant that COVID has played a role, are there any other gating factors which remain with Biosimilar Lecentis? And also, could it be, is there a way for you to narrow the range with the Biosimilar Avastin filing? Yes, I'm sorry, Balaji. Could you repeat the last part of your question? And if you could narrow the range with when you expect to file by similar amounts.
Hi, good evening and thanks for taking the questions.
Firstly could we start with an update on the on the fighting please while I'm cognizant that Covid ask played at all.
Are there any other getting packed is which remain with vitamin levels.
And also could it be.
Is there a way for you to narrow that ancient Biosimilar Alaskan filing.
I'm sorry could you repeat your last part of your question and if you could narrow the range of it when you expect to find Biosimilar last time.
Dennis M. Lanfear: Oh, okay. Well, you wanted to start out with the BioWAC Lucentis, correct? That is right, yeah. So, as you know, the BioLock Lucentis sponsor is our partner. That's one product where we do not interact directly with the FDA and so on. However, I think they've made very good progress on the manufacturing issues there. They've finished those up. They've written those up.
Oh, Okay, well anyone it started out with the firework Lucentis correct.
That is right.
So.
You know the biotech Lucentis spa.
Sponsor is our partner.
It's one product, where we do not interact directly with the FDA and so on however, I think they've made very good progress on the manufacturing issues. There. They finished those up they've written those up.
Dennis M. Lanfear: They're in the process of submitting those documents to the FDA, and as I indicated to you, they're going to actually interact with FDA early in the year here on that product. So I think that's basically moving forward. The COVID situation in Europe with the manufacturing facility did cost them some time, but I think they've gotten past that. With respect to the, I've asked them about somewhere that we could in-license to invent.
They are in the process of submitting those.
Documents to the FDA and as I indicated to they're going to actually interact with FDA early in the year here on that product. So I think that's that's basically moving forward the covid situation in Europe with the manufacturing facility did cost them. Some time, but I think they've gotten past that with respect to the.
<unk>.
Of asking about somewhere that we in license event I think it's fair to say that we're pleased with the progress on that product.
Dennis M. Lanfear: I think it's fair to say that we're pleased with the progress on that product. There are certain interactions that have gone back and forth with the FDA. As you know, we have a planned pharmacokinetic study with that product, and we'll probably have something to say about that when it's completed. But with respect to the actual BLA filing, the best I can do right now is 2021 for you. But after we get past a few more interactions with FDA and complete the PK study, I'll be able to give you some more granularity around that. Got it, David.
There are certain interactions have gone back and forth with the FDA as you know we have a plan pharmacokinetics study with that product and we will probably have something to say about that when it's completed but with respect to the actual BLA filing the best I can do right now is the.
Is the 2021 for you, but after we get past a few more interactions with FDA and complete the PK study I'll be able to give you some more granularity around that one.
Got a David.
Balaji V. Prasad: So on Udenica, we've been speaking to multiple experts on the biosimilar side, and clearly, the unanimous view is that biosimilars will expand markets, especially in oncology. And we have had this discussion in the past, too. Based on what we also saw with Amgen's comments, both new and mid-course patients are shifting to biosimilars. So you would probably have seen a greater share coming through this quarter, but apparently, it doesn't seem to have happened. Is there anything else that's happening that we're missing out on here? This quarter is a little complicated due to COVID, as has been the case this year, but I'll let Dinesh offer you some comments and color on that. Dinesh?
Have you had any cough. So we've been speaking to multiple expires on on the <unk> side and clearly Diana Spiel is that Biosimilars will expand markets, especially in oncology and we have had this discussion in the past to base.
Based on what we also solve its amgen's comments, both new unmik cause patients are shifting to biosimilars. So it I've seen probably greater share coming through this quarter, but apparantly doesn't seem to have happened is anything else that that's happening the famous Nokia.
This quarter is a little complicated to the Covid as has been this year, but I'll, let Dennis.
Offer you some comments and color on that <unk>, yes, yes. Thank you. Thank you for that question biology.
Dinesh Piranduri: Yeah, yeah. Thank you. Thank you for the question, Balaji. You know, we believe that there is still a significant opportunity with Udenic. Udenic, as you know, is a trusted and reliable brand delivering value in the Peckfield-Graston market, where the originator still controls about 70% of the market share, and it offers a huge opportunity for us moving forward.
We believe that.
There is still a significant opportunity videogenic.
<unk> is you know is.
Rested and reliable brand delivering value in the bank progressive market in which the originators still controls about 70% market share and it offers offers a huge opportunity for us moving forward.
Dinesh Piranduri: As you look at, you know, our first year launch, Udenic entered the market share with a market share of 20%, which was pretty substantial. And our market share continues to grow as we speak. So, we are pretty confident about, you know, what lies ahead of us despite the headwinds of COVID and despite the entry of competition as well. So, and to your point, additionally, with the expansion of NCCN guidelines, we believe the market will continue to grow. Thank you.
As as you look at you know our our first you launch <unk> exited the market share with the market share of 20% of which was pretty substantial and our market share continues to grow.
As we speak so we are pretty confident about.
What lies ahead of us despite the headwinds of Covid.
And despite the entry of competition as well so and to your point. Additionally, with the expansion of answered GM guidelines, we believe.
Dennis M. Lanfear: I would just tell you that COVID overhangs the market. You just see these fluctuations. There's an ebb and flow.