Q3 2021 Coherus BioSciences Inc Earnings Call
Operator: Good day, and thank you for standing by. Welcome to the third quarter 2021 Koheros Biosciences conference call.
Good day and thank you for standing by welcome to the third quarter 2021 go Harris Biosciences Conference call.
Operator: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, but David will still go ahead. Please go ahead.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
I ask a question during this session you will need to press star one on your telephone.
Any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today Mcdavid Stilwell. Please go ahead.
McDavid Stilwell: Good afternoon, everyone, and thank you for joining us. We issued a press release earlier today announcing our 2021 third quarter results. This release can be found on Coharras Bioscience's website. Today's call includes forward-looking statements regarding Coheris' current expectations. These statements include, but are not limited to, our ability to advance our biosimilar and immunoncology 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 expenses for 2021.
Thank you.
Good afternoon, everyone and thank you for joining us.
We issued a press release earlier announcing our 2021 third quarter results. This release can be found on the <unk> Biosciences website.
Today's call includes forward looking statements regarding <unk> current expectations.
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 <unk> and other potential products in the future.
Our ability to meet our R&D and SG&A expense guidance for 2021.
McDavid Stilwell: It's one of 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. 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.
As well as our uses of capital all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ from these statements.
These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in documents that we file with the securities and Exchange Commission specifically in our quarterly report on Form 10-Q for the quarter ended September 32021 that we filed earlier this afternoon.
McDavid Stilwell: Specifically, in our quarterly report on Form 10Q for the quarter ended September 30th, 2021, that we filed earlier this afternoon. The forward-looking statements stated today are made as of this date, and we undertake no duty to update such information except as required under applicable law. With me on today's call are Denny Lanfier, CEO of Coheris, Paul Reeder, Executive Vice President of Commercial Operations and Market Access, and Chris Thompson, Executive Vice President of Sales. I will now turn the call over to Denny.
The forward looking statements stated today are made as of this date and we undertake no duty to update such information, except as required under applicable law.
With me on today's call are Denny Lanphier, CEO Erez <unk>.
All reader executive Vice President of commercial operations and market access and Chris Thompson Executive Vice President of sales.
I will now turn the call over to Jay.
Dennis M. Lanfear: Thank you, McDavid, and thank you all for joining us this afternoon. I'm pleased today to report that our recent key milestones are driving near-term growth in our commercial product portfolio. We now have three PLAs under FDA review and expect to pursue multiple additional FDA applications in 2022 based on recently reported positive clinical data. We expect within a year to have four products approved, and within two years, they will have five products launched and driving significant revenue growth to fund our expansion in Oncology.
Thank you David and thank you all for joining US. This afternoon I'm pleased today to report on our recent achievement of key milestones driving near term growth of our commercial product portfolio.
We now have three BLA is under FDA review.
<unk> to pursue multiple additional FDA applications.
In 2022.
Just on recently reported positive clinical data.
We expect within a year to have four products approved within two years.
Products launched and driving significant revenue growth to fund our expansion in oncology.
Since our last conference call in August we reported a series of significant achievements towards the school.
First the positive data from your deneke on body injector clinical trial.
It is expected to enable a 2022 submission of a prior approval supplement so you've kind of kept BLA.
Following the 10 month review period for the opioid submission we plan to launch directly upon approval.
Dennis M. Lanfear: Since our last conference call in August, we've reported a series of significant achievements towards its goal. First, positive data from the Udenica On Body Injector Clinical Trial, which is expected to enable a 2020 submission of a prior approval supplement to the Udenica BLA. Following the 10-month review period for the OBI submission, we plan to launch directly upon approval. The FDA has accepted the BLA for our biosemeter leucentis, CHS 201, and assigned a target action date of August 2020. We plan to launch directly upon approval. The FDA review of the BLA for our file-same, Humaira, CHS1420, is proceeding well and advancing toward the December 2021 action date. We planned to have lunch in July 2023.
The FDA has accepted the BLA for our Biosimilar Lucentis CHF 200 Watt and assigned a target action date of August 2022, we plan to launch directly by approval.
The FDA review of the BLA for our Biosimilar Humira CHF 14, one.
Is proceeding well and advancing towards December 2021 date.
We plan to launch in July 2023.
The FDA also accepted Palomas BLA for advanced nasal pharyngeal carcinoma, including in combination with chemotherapy for first line and it's about therapy for second line and greater.
And granted priority review with a target action date of April 2022.
We plan to launch toward Palomar directly mixture.
That's true.
Recently presented positive data from the esophageal squamous cell carcinoma phase III clinical trial are expected to enable the submission of a tour of Palomar BLA supplement in 2022.
Positive progression free survival data from the phase III clinical trials evaluating for our Palmetto and non small cell lung cancer were presented in September.
Final PFS and overall survival data are expected by early first quarter 2022.
After which we'll hear some partner Junichi boats I plan to discuss potential submission of a BLA supplement with the FDA.
With respect to CHF 305, our Biosimilar Avastin candidate, we are conducting a three way PK studies to facilitate its BLA submission in 2022.
Dennis M. Lanfear: The FDA also accepted the Torpalmab BLA for advanced nascental carcinoma, including in combination with chemotherapy for first line and espionotherapy for second line and greater, and granted priority for the target action date of April 2022. We plan to launch our Palomab directly upon the, Recently presented positive data from the esophageal squamous cell carcinoma phase three clinical trials are expected to enable the submission of Positive progression-free survival data from the Phase 3 clinical trial evaluating our Pal-Map and Nant Mal Cell Lung Cancer were presented in September.
The news flow will continue through 2022 as towards clinical data continue to accumulate and non small cell lung cancer.
Small cell lung cancer triple negative breast cancer and about a <unk>.
Nope.
Also next year, we expect data from the tour call me, a combination trial Junichi biosciences conducting with their anti <unk> antibody, which we have option rights.
Interest into our Palomar combinations has grown as data has been presented.
This year.
We continue to receive inquiries from other parties interested in evaluating a novel agents, but towards element.
So it's a combination therapies to provide additional opportunities for propel nib growth and differentiation.
Judy I think that continues to provide a strong source of funding for pipeline investments or upcoming product launches.
Net sales declined to $83 million in the third quarter.
Within the context of increasingly can be increasingly competitive pegfilgrastim market.
We look forward to launching new deneke on body injector, which will directly compete with neulasta.
Which retain 50% sure the overall pegfilgrastim market.
We were pleased with the official notice last week that CMS has extended enhanced Medicare reimbursement for your desk.
And the 340 B hospital setting through year end 2022.
Dennis M. Lanfear: Final PFS and in-room overall survival data are expected by early first quarter 2022, after which, Goheris and partner June Shebao Sciences plan to discuss potential submission of a BLA supplement with the FDA. With respect to CHS 305, our biosimilar of Aston candidates, we are conducting a three-way PK study facilitated BLE submission in 2022. The new flow will continue through 2022 as TorpalMap clinical data continue to accumulate in non-small lung cancer, Mawallin Cancer, triple negative breast cancer, and epithelular carcinoma.
Pass through status was scheduled to expire on March 31st two so this extension was announced.
Led by our government affairs team in collaboration with female.
I'll now turn the call over to Paul Reader for a review of <unk> third quarter performance.
Paul will also provide an update on launch prep towards both tour Appel Mab and are loosened.
Al.
Thank you Danny.
You didn't condensed sales were 83 million in the third quarter down 6% from the second quarter.
This was driven by an 8% decline in units, partially offset by a favorable shift in segment mix.
Our market share declined from 19% in the second quarter to 18% in the third quarter.
With share loss being largely limited to $3 40 would be our lowest margin business or new entrants have been gaining share.
Our share in clinics group, and we held share and notably 40 demos.
Dennis M. Lanfear: Also next year, we expect data from the Toropalmap Combination Trial that Junchee Biocscience is conducting with their antitigid antibody, to which we have the option right. Interest in Torep combinations has grown as data have been presented and published this year. We continue to receive inquiries from other parties interested in evaluating their novel agents with Thorpelement. Such combination therapies provide additional opportunities for ToropalMap growth and differentiation.
As we saw in each of the last two years, the pegfilgrastim market declined modestly.
And we expect a return to low single digit market growth in the fourth quarter.
Until Covid received more broadly there will continue to be a short term advantage favoring the originators on body device, which retains 50% of the overall market.
Continue to believe that in the long term taking share from <unk> will be a source of growth for biosimilars and especially for your datacom.
The other deal.
And our control.
The level of price erosion precipitated by our competitors.
Dennis M. Lanfear: Udenica continues to provide a strong source of funding for pipeline investments to support upcoming product launches, although sales declined to 83 million in the third quarter. Within the context of increasingly competitive, We look forward to launching the Udeneca On Body Injector, which will directly compete with Nuasta-onpro, which retains a 50% share of the overall exografted market. We were pleased with the official notice last week that CMS has extended enhanced Medicare reimbursement for Udenica in the 340B hospital study through year end 2022. Pass-through status was scheduled to expire on March 31st, 22.
We seek to be good stewards of our ASP.
We believe relative price stability benefits our customers our strategy is to maximize long term downtick in revenues.
Now I'd like to talk about commercializing our pipe.
You are now preparing for the launch of two new products in 2022 port Palomar for nasal pharyngeal carcinoma.
CHS 201, our Biosimilar new centers, we expect to launch both products directly to the bottom.
These apparent fuel carcinoma is a rare cancer, where currently there are no PD one inhibitors that are FDA approved for use.
For Taliban not only has the potential to be the first and only PD one inhibitor indicated this tumor type.
But you also established a new first line standard of care.
Our oncology commercial capabilities have been built to scale and the torn palomar effort efficiently integrated into our existing infrastructure.
Launch preparations are underway and progressing well.
Dennis M. Lanfear: So this extension was announced by our government affairs team in collaboration with CMO. I'll now turn the call over to Paul Reeder for a review of Udenica's third quarter performance. Paul will also provide an update on launch prep for both Tora Palomab and our Lucentus Public Similar. Thank you, Denny.
With respect to our Lucentis biosimilar.
Our FDA action date of August 2022 will allow us to launch and compete early.
<unk> similar market formation.
Branded lucentis market is expected to be.
One 3 billion in 2021.
Our launch planning is underway and progressing well.
We look forward to competing in this large market.
Paul Reider: The Dena Conned sales were 83 million in the third quarter, down 6% from the second. This was driven by an 8% decline in units, partially offset by a favorable shift and segment. The market share declined from 19% in the second quarter to 18% in the third quarter. However, with share loss being largely limited to 340B hospitals, our lowest margin business, or new entrants have been gaining share. Our sharing clinics grew, and we held shares in non-340B hospitals. As we saw in each of the last two years, the Peggfield Grasda market declined modestly in the third quarter, and we expect a return to low single-digit market growth in the fourth quarter.
We intend to launch with a dedicated ophthalmology sales team, while leveraging our existing key account market access.
<unk> support capabilities for my colleagues.
I'll now turn the call over to Mcdavid will review the quarter's financial results.
Thanks, Paul.
The details of our financial results are in the press release and in the 10-Q, we filed this afternoon. So I'll now focus on a few highlights.
For the third quarter of 2021, we reported a $38 5 million net loss on a GAAP basis.
Cash flow from operating activities was $13 7 million for the third quarter of 2021.
As detailed earlier in the call net product revenue was 83 million a decrease from $88 million and you did a good net sales reported the prior quarter.
Wholesaler inventory remained within the normal range.
In the first quarter of 2021, we depleted the inventory manufactured and expense prior to <unk> approval and.
And since then per unit acquisition costs are fully reflected within Cogs.
Paul Reider: Until COVID recedes more broadly, there will continue to be a short-term advantage favoring the originator's on-body device, which retains 50% of the overall market. We continue to believe that, in the long run, taking share from OnPro will be a source of growth for biosimilars and especially for Udana. The other element beyond our control is the level of price erosion precipitated by our competitors.
Therefore cost of goods as a percent of net revenue.
Increased from the year ago quarter.
The third quarter 2021, Cogs was also impacted by a write off of $5 2 million related to inventory that did not meet acceptance criteria.
We expect Cogs as a percentage of net sales to decline in the fourth quarter to the mid teens.
Including a mid single digit royalty we owe.
Through mid 2024.
In the long run starting in 2024, we expect you did a good gross margins to return to 90% or higher as we realize the benefits of a significant manufacturing process improvements and royalty exploration.
Paul Reider: We seek to be good stewards of our ASP, as we believe relative price stability benefits our customers. Our strategy is to maximize long-term undistributed revenue. Now I'd like to talk about commercializing our pipeline. You're now preparing for the launch of two new products in 2022, Torpalimab for nasal pharyngeal carcinoma, and CHS 201 is a biosimilar lucid. We expect to launch both products directly upon Nasolaryngyl carcinoma is a rare cancer where currently there are no PD1 inhibitors that are FDA approved for you. Palomab not only has the potential to be the first and only PD1 inhibitor indicated for this tumor type, but it also establishes a new first-line standard of care.
Research and development expenses for the third quarter of 2021 were $54 1 million compared to $38 9 million for the same period in 2020.
The increase reflects cost to advance our late stage pipeline.
Recall that we expect to bring four additional products to market over the next two years and also the on body injector presentation of your deneke.
And we are investing this year in activities, such as regulatory affairs and manufacturing scale up for CHS 14, 20 clinical development and BLA filings for <unk> and the clinical trial for CHS III zero, five Athlon deneke on body injector.
Selling general and administrative expenses were $39 $9 million in the third quarter of 'twenty, one as compared to $32 million in the year ago quarter.
McDavid Stilwell: Our oncology commercial capabilities have been built to scale, and the Torpalab effort will be efficiently integrated into our existing infrastructure. Launch preparations are underway, and progressing well. With respect to our Lucentus Biosimilar, our FDA action date of August 2022 will allow us to launch and compete early in the biosimilar market formation. The branded Lucentus market is expected to be 1.3 billion in 2021. Our launch planning is underway and progressing well, and we look forward to competing in this large market.
The increase was driven primarily by higher you didn't go to commercialization activities as well as stock based and other compensation expense.
We ended the quarter with cash cash equivalents and marketable securities of $468 $7 million compared to a balance of $454 5 million at June 32021.
We are maintaining our full year guidance for R&D and SG&A expense of 370 million to $400 million.
Excluding the first quarter upfront payment to June she biosciences and.
This range includes approximately 50 million to 55 million stock based compensation expense.
I'll now turn the call back to Jamie for closing remarks, Thanks, David.
The next 12 months will be exciting time at <unk>.
Potential for additional clinical data for <unk> and neutral.
Our growing immuno oncology pipeline FDA action on multiple new product candidates.
And then just big commercial launches for both <unk> and CHF 201, our Lucentis biosimilar.
McDavid Stilwell: We intend to launch with a dedicated ophthalmology sales team while leveraging our existing key account, market access, and patient support capabilities from my college. I'll now turn the call over to McDavid for a review of the quarter's financial results. Thank you all. The details of our financial results are in the press release and in the tin queue we filed this afternoon, so I'll now focus on a few highlights.
In January we are planning to host Bruce Daniel coherent pipeline of business review meeting in New York City.
With progress in our pipeline and our strategic expansion into oncology.
Our business is rapidly evolving we plan to provide a deep dive into the various elements of our business and give investors and analysts an opportunity here from additional members Jean.
We will provide additional information little closer to the date and we look forward to seeing you there.
I'll now ask the operator to open the line for questions operator.
Absolutely as a reminder to ask a question you will need to press star one on your telephone.
McDavid Stilwell: For the third quarter of 2021, we reported a $38.5 million net loss on a gap basis. Cashflow from operating activities was $13.7 million for the third quarter of 2021. As detailed earlier in the call, net product revenue was $83 million, a decrease from $88 million in Udica Net Sales recorded the prior quarter. Wholeshaler inventory remained within the normal range.
Question <unk>. Please.
The standby, while we compile the Q&A roster.
Your first question comes from the line of <unk> of Mizuho. Your line is open.
Good afternoon, guys and thanks for the questions.
Just a couple from me one on the Datacom body.
Injector and then one on ticket if I can so on the on the on body injector guys. Congrats on the progress.
Curious.
How are you guys are thinking about the revenue profile here for Ya Deneke.
If you're if we shouldn't be expecting a bimodal peak obviously consensus.
McDavid Stilwell: In the first quarter of 2021, we depleted the inventory, manufactured, and expensed prior to Udica approval, and since then, per unit acquisition costs are fully reflected within COG. Therefore, cost of goods as a percent of net revenue has increased from the year-ago quarter. The third quarter, 2021 COGS, was also impacted by a write-off of 5.2 million related to inventory that did not meet acceptance criteria. We expect COGS as a percentage of net sales to decline in the fourth quarter to the mid-teens, including a mid-digit royalty we owe through mid-2024.
Isn't modeling a bimodal peak right now.
How you are thinking about that and if late 'twenty two is even in the cards for when we when we can expect.
Commercial on body injector.
And then on page eight I'm, just giving she ARCUS release Tonight, where they mentioned that the triplet.
With their PD one ticket.
And the adenosine.
It looks like it's numerically outperforming doublet, just curious how youre thinking about what you.
Would need here to opt in.
I mentioned she ticket if you'd be looking at doublet versus doublet, a doublet versus.
A triple it.
Market, just curious how you're thinking about what.
What you need here for for the often thank you.
Oh, Thank you very much for the question. So let me take the opioid question first.
With respect to potential launch timing, we have not yet.
Was that we had a few conversations last year I remember you had some very serious questions at the time the timing of our PK study.
Which I think you turned out to be a little pretty close out actually it was very very timely.
McDavid Stilwell: In the long run, starting in 2024, we expect Eugenica gross margins to return to 90% or higher as we realize the benefits of a significant manufacturing process improvement and loyalty expiration. Research and development expenses for the third quarter of 2021 were $54.1 million compared to $38.9 million for the same period in 2020.
We won't have very much else to say about opioid and so we have another disclosure to make and so we will just viciously declining to give some additional color with potential timing on that.
With respect to the bi modal.
Modeled for OPI, and how we expect <unk> to do in the market I'll just punt that one over to Paul for a comment Paul.
Stephanie Thanks for your questions.
The last dog pros proven to be resilient over the last two years with Covid, so moving on to 50% market share. It represents a very sizable.
<unk> for our on body device.
McDavid Stilwell: The increase reflects costs to advance our late-stage pipeline. Recall that we expect to bring four additional products to market over the next two years and also the on-body injector presentation of Eudenica. And we are investing this year in activities such as regulatory affairs and manufacturing scale-up for CHS-1420, clinical development and BLA filings for Tora Palomab, and a clinical trial for CHS 305 and one for Eudinica on-body injectors. Dying, General, and Administrative expenses were $39.9 million in the third quarter of 21, as compared to $32 million a year ago. The increase was driven primarily by higher Eugenica commercialization activities, as well as stock-based and other compensation. We ended the quarter with cash, cash equivalents, and marketable securities of $468.7 million, compared to a balance of $454.5 million at June 30th, 2021.
If approved and so we do see that as a growth catalyst and aligns with our overall strategy of maximizing the long term revenue support.
Got it.
Now with respect to the double versus triple net.
With the kitchen and so on.
I think we've talked about this a little before it's Lee.
We view towards element really as the foundation stone and the backbone for immuno oncology.
Franchise, and so we contemplate combining tour upheld met.
With a number of agents, including ticket so we.
We expect of course to evaluate doublet strategy with her comment we also contemplate evaluating triplet strategies with Palmetto, we see combinations as the wave of the future and I think we've talked previously about our efforts at co formulation, which is now well underway.
That is toward pellet mab.
With various agents, including of course the ticket.
Little more color for you on that and perhaps some data at.
At the analyst day meeting in January but yes.
That we believe is the future of immuno oncology is sort of double and triple combinations.
And we're gearing up to evaluate those.
Super helpful. Thanks, So much and congrats again on the progress.
It was good to hear from you said.
Your next question comes from the line of Ken Fisher Quarry.
And company your line is open.
Hey, guys. How are you just a couple of questions Denny the strategy were taken in the PD, one market seemingly being validated by others, who want to take a similar approach. So can you talk about the likely evolution of the marketplace.
McDavid Stilwell: We are maintaining our full year guidance for R&D and SGMA expense of $370 million to $400 million, excluding the first quarter upfront payment to June Chief Bioscience. And this range includes approximately 50 million to 55 million dollars in stock-based compensation. I'll now turn the call back to Jimmy for closing remarks. Thanks, David. The next 12 months will be an exciting time, and we will go here with the potential for additional clinical data for TOROtlMab and new termites.
Terms of pricing and who can play in what area and why and then on Lucentis.
Just wondering.
It seems to be more of a managed care.
Driven approach at least I would gather that would be the case different than your deneke that had heavy commercial spending. So can you talk about the lucentis opportunity in terms of the spend necessary to achieve what you want to accomplish and then.
Whether a biosimilar lucentis may be a step through to the to Eylea and others. So maybe the evolution. There and then lastly, just wondering if you all would take a shot about timing of profitability again seems like we have a lot of good things happening, but wondering if you think.
McDavid Stilwell: Growing Amino Oncology Pipeline, FTA Action on multiple new product candidates, and anticipated commercial launches for both TORO Palomab and CHS 201 or Lucentus Quouse. In January, we are planning to host the first Daniel Coharris Pipeline and Business Review meeting in New York City. With progress in our pipeline and our strategic expansion into oncology, our business is rapidly evolving. We plan to provide a deep dive into the various elements of our business and give investors and analysts an opportunity to hear from additional members of the team. We'll provide additional information a little closer to the day, and we look forward to seeing you there. I'll now ask the operator to open the line for questions.
<unk> 2023, we can break out in kind of forever, but profitability kind of.
So what we what we experienced as we go forward. Thanks a lot.
Alright.
That.
Just two questions there first with respect to incentives I think that the.
The expenditures are relatively modest in the Grand scheme of things, we've talked before about how we intend to leverage our existing infrastructure.
Both in terms of the marketing side and so forth and we've also talked about the size of potential sales force and boots on the ground being 2025 folks something on that order.
Let Paul answer the follow on question with respect to incentives.
Operator: Absolutely. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Salim Sayy, of Mizuel. Your line is open.
With respect to.
How do we see the market shaping up.
Participation during market formation, and a potential step through.
Sure. Thanks for your question Ken So.
Unlike oncology this retina market is highly concentrated.
So you've got it.
Salim Qader Syed: Good afternoon, guys, and thanks for the questions. Just a couple for me, one on the Udenica on-body injector and then one on Tidget, if I can.
Fairly small market that drives.
The largest percent of utilization the other dynamic that's different is that it's much more Medicare driven because of the age of the population of these patients in.
Salim Qader Syed: So on the On Body Injector, guys, congrats on the progress. Just curious, you know, how you guys are thinking about the revenue profile here for Udenica, if we should be expecting a bimodal peak; obviously, consensus isn't modeling a bimodal peak right now. I'm just curious how you're thinking about that and if late 22 is even in the cards for when we can expect, you know, the commercial on-body injector.
In general and so.
The impact of commercial.
Access isn't as great as it is in oncology in certain tumor types. So we believe we can be very efficient.
Through proper targeting.
At the retina specialist level.
Census users.
Ensuring that really.
Pricing and contracting meats.
Meets the customers' needs because those are big drivers and so the good thing is.
Not having that large commercial requirement on the payer side.
Salim Qader Syed: And then on Tid, just given the Arcus release tonight where they mentioned that the triplet, with their PD1 tigit and the adenosine, it looks like it's numerically outperforming the doublet. Just curious how you're thinking about what you would need here. opt in on the Jinchi tigit if you'd be looking at doublet versus doublet or double it versus a triplet, you know, in the market, just curious how you're thinking about what you need here for the opt-in. Thank you.
It really reduces the need to stack the rebates on the payer and the provider. So so we think we're going to be able to leverage majority of our commercial infrastructure will have a very.
Very focused retina team and we'll be able to approach this market in a very efficient and synergistic way and we believe.
Dan.
With a high degree of confidence we're going to compete very successfully given our track record here.
And Ken can you remind me a little bit about what you would like to know about pricing and the PD one market any detail, where you're just looking for a general color about.
Dennis M. Lanfear: Thanks very much for the question, Celine. Let me take the OBI questions first. With respect to potential launch timing, we have not yet disclosed that. We had a few conversations last year.
What we think the pricing is going to do and so yes, there's a lot of folks actually it's good to see I guess in one sense that to see when those competitors, but folks are looking to take a similar strategy. So just you know there seems to be an evolution here folks pursuing a similar game plan as yourself just how you see this market.
Dennis M. Lanfear: I remember you had some very salient questions at the time about the timing of our BK study, which I think you turned out to be pretty close on, actually. It was very, very timely. But we won't have very much else to say about OBI until we have another disclosure to make, so we'll just graciously decline to give some additional color with potential timing on that. With respect to the bimodal model for OBI and how we expect OBI to do in the market, I'll just punt that one over to Paul for comment. Thanks, Daddy.
Playing out and yes pricing and kind of who takes kind of what area and why and.
Just give us a sense of kind of as it gets a little bit more crowded. However, you want can participate.
Well first I would say that I think it's a bit premature for us to comment on pricing of particular segments.
I'd, rather have either approvals or at least confirmatory data and indications or filing for particular indications.
We started talking about how we're going to go into particular segments, whether thats, a non small cell or Suffolk.
Or with others.
I think though that too.
Two broad.
It is too broad.
Sort of things emerge, though from the market and the very long run.
Think that PD ones definitely will moderate in terms of pricing in the market.
Paul Reider: Thanks for your question, Celine. Yeah, I mean, the new Last Hog Pro has proven to be resilient over the last two years with COVID. So holding on to 50% market share represents a very sizable opportunity for our on-body device, if approved. And so we do see that as a growth catalyst. They're in alignment with our overall strategy of maximizing long-term revenues for Udenica. Now, with respect to the doublet versus triplet and so on, you know, I think we've talked about this a little before, Selene.
Nearly will be replaced by doublets ever co formulated.
Combination strategies, which will relieve a little under pressure.
Therapeutic stack in the pricing of the therapeutics that which.
Which is probably not sustainable in the longer in the longer term, but if you let us get a couple of rules and a few other submissions under our belt and we will be happy to talk a little bit more about our strategies.
Let me get into each of these each of these markets.
Let me take your last question and I'll, Let me David Chime in on this one I think it was about profitability in 2023, and how we can see that evolving in and so on and so mcdavid you want to take that one yeah. Yeah. Thanks for the question Ken So we recognized for a long time.
Paul Reider: We view Tora Palomab really as the foundation stone and the backbone for our immunoling ecology franchise, and so we contemplate combining TORA paltmat with a number of agents, including Tidgit. So we expect, of course, to evaluate doublet strategies with Tauro Pallamemans. We also contemplate evaluating triple strategies with Toropalab. We see combinations as the wave of the future. And I think we've talked previously about our efforts at co-formulation, which is now well underway, that is, Torpalmaab, with various agents, including, of course, the digit.
2022 would be a transition year between you getting the sales.
Lucidly and.
Fully diversified portfolio, which will be up and running we believe in 2023. So we're managing cohere sufficiently towards the near term launch of four new brands as well as the on body injector Zeneca and I'll remind you that our commercial organization is already operating at scale and so new law.
<unk> don't required to novo construction of commercial operations.
And we believe that additional revenue would drop quickly to the bottom line. So in 2023 fully diversified portfolio should be should be online.
We will have four biosimilars, including <unk> with multiple different presentation UBI, giving it the second win as well as towards an amount of approved with multiple.
Paul Reider: We'll have a little more color for you on that and perhaps some data at the Analyst Day meeting in January. But yes, that, we believe, is the future of immunolology, sort of doubled and triple combinations, and we're gearing up to evaluate those. Super helpful. Thanks so much and congrats again on the progress.
Multiple different indications at year so.
It's 23 setting up to be a very exciting year in 2022.
A year, where the story will be coming together rapidly.
I would characterize 2023.
Salim Qader Syed: Your next question comes from the line of Ken Keshetore of Cowan and Company. Your line is open. Hey, guys, how are you? Just a couple of questions.
And having a perhaps modest increases in expenses.
I think David indicators by leverage that we're going to exploit went into oncology between your dedicated best in a biosimilar and the PD one.
Ken Keshetore: Hey, guys, how are you? Just a couple questions. Denny, the strategy you've taken in the PD1 market seems to be being validated by others who want to take a similar approach. So can you talk about the likely evolution of the marketplace in terms of pricing and, you know, who can play in what areas and why?
But potentially substantial increases in revenues of default launch. So I think I think 23 of the year those shape up quite well.
Thanks, so much guys.
Alright, thank you.
Your next question comes from the line of Chris Schott of Jpmorgan. Your line is open.
All right great. Thanks, so much for the questions just two one you deneke.
Ken Keshetore: And then on Lucentis, just wondering, this seems to be more of a managed care driven approach. At least, I would gather that would be the case, different than Udenica which had heavy commercial spending. So, can you talk about the Lucentis opportunity in terms of the spend necessary to achieve what you want to accomplish, and then whether a biosimal Lucentis may be a step-through to Ilya and others and to, maybe, the evolution there?
First just elaborate a bit on sequential trends as we think out to <unk>. It sounds like youre expecting modest volume growth for the market next quarter, but can you just talk a little bit more about the competitive landscape in the sequential price expectations is there more kind of mix shifts away from 340, B et cetera, I'm trying to get my hands around.
Can we think about you kind of had a floor of this quarter or is that a business that could continue to sequentially erode from here and then my second question was just on the on body product as we think about that launch over time is there an ability to differentiate pricing for that product versus the existing format given the different competitive landscape, especially in the two prong.
Ken Keshetore: And then lastly, just wondering if you all would take a shot at timing profitability again. It seems like we have a lot of good things happening, but wondering if you think, uh, 2023 we can break out and kind of forever put profitability kind of, um, so what we, what we experience as we go forward. Thanks a lot.
Or is it really more of a volume play.
Going after that 50% of the market, but still is sitting with umbrella. Thanks. So much.
Thanks, a lot Chris.
Chris with respect to the sequential quarter to quarter on that one over to Paul reader and still give us any comment on that Paul.
Yes. Thank you, yes so.
Obviously, our strategy is to maximize long term revenues and we're going to continue to balance the trade off between.
Price and share by customer competitor.
The competitive intensity heats up.
Dennis M. Lanfear: All right, I'll try to impact that. Again, there are three questions there. First, with respect to Leszentes, I think that the expenditures are relatively modest in the grand scheme of things. We've talked before about how we intend to leverage our existing infrastructure, you know, both in terms of the marketing side and so forth. And we've also talked about the size and potential sales force and boots on the ground being 25 folks, something around that order. I'll let Paul answer the following question with respect to Lucentis, with respect to how we see the market shaping as a result of our participation during market formation and the potential step through. Sure, thanks for your question, Ken.
Likely new competitors coming in in 2022, So we're gonna take a very careful.
Review of that over time again, we're going to be focusing on neulasta, which is the largest source of revenue opportunity for us moving forward and we're going to be looking at really those higher margin higher value segments, which is the clinic in the north.
340, <unk> segments, which as we demonstrated in the third quarter, we we grew that clinic business.
Held for under intense pricing competition, and only 340 b. So.
So that's going to continue to be our focus I think it's reasonable to assume with competitive.
Pricing pressures some some continued.
Price declines.
The clients into 2022.
With some moderation of that.
Mid and long term.
Let me take the let me take that.
With respect to <unk> that you had credit if I can give you some out there.
First thing I'd say is that after our announced that successful PK study, which by the way is I think is a really pivotal part of the development program that is the most difficult to pull off actually.
Paul Reider: So, you know, unlike oncology, the retina market is highly concentrated. And so, you know, you've got, you know, a fairly small market that drives the largest percent of utilization. The other dynamic that's different is that it's much more Medicare driven because of the age of the population of these patients, in general. And so, you know, the, the, the, the, the, the, impact of commercial access isn't as great as it is in oncology and certain tumor types.
Conceiving of device manufacturers.
And to demonstrate.
Similarity with respect to pharmacokinetics I think is the tough thing after that Youre youre in the business of filing an IND filing and approval, but since we made that announcement I'm very clear to us that there is really significant pent up demand in the market for non body system.
In the hands of a biosimilar companies such as you've done a cut.
I think we're pretty optimistic about that and how it's going to move up just how we're going to price that and what our strategy is for penetrating the market, how we're going to develop a holistic value proposition such as we did when we first came out with it.
Paul Reider: So we believe we can be very efficient, you know, through proper targeting at the retina specialist level, the highly scented users, and ensuring that, really, the pricing and contracting really meet the customers' needs because those are big drivers. And so, you know, the good thing is not having that large commercial requirements on the payer side. It really reduces the need to stack the rebates on the payer and the provider side.
With the Prefilled syringe.
Leave that for a little later down the road when we actually have that device approved in hand, we'll be happy to talk about it then as opposed to talk about it now, but I would note the very significant pent up demand for them.
I hope that's helpful.
Alright, thank you.
Your next question comes from the line of Douglas Tsao of H C. Wainwright. Your line is open.
Questions one penny in terms of the eugenic that there's less.
I'm just curious once you eventually get your own body device to the market do you anticipate.
Paul Reider: So we think we're going to be able to leverage the majority of our commercial infrastructure. We'll have a very, um, a very focused retina team, and we'll be able to approach this market in a very efficient and synergistic way. And we believe, you know, Ken, with a high degree of confidence, we're going to compete very successfully, given our track record here.
That largely going to the current you've done a couple of business or from an account basis for this represent an opportunity to really penetrate accounts, where you haven't had as much penetration today.
Hey, Doug Great question upfront that when the pulp, but what about the segments in the accounts.
Yes. Thanks for your question, Doug No we see that.
The approval and launch of our on body device.
Enables us to go after that 50% of Neulasta.
Ken Keshetore: And can you remind me a little bit about what you would like to know about pricing in the PD1 market, any detail where you're just looking for general color about what we think the pricing is going to do? Yeah, Danny, there are a lot of folks actually. It's good to see, I guess, in one sense, I have to see when there are competitors, but folks are looking to take a similar strategy. So just, you know, there seems to be an evolution here, folks pursuing a similar game plan as yourself, just how you see this market playing out and, yes, pricing and kind of who takes kind of what area and why and just give us a sense of kind of as it gets a little bit more crowded, how everyone can participate.
So that's really the strategy, we're going to take.
On approval.
And that's where that's where the opportunity is so so we see it really being a play to capture more share of the ore body.
<unk>.
Well I guess policies.
What I'm trying to understand.
Where the on body market exist I mean are there sort of clinics or hospitals et cetera, where you just simply haven't been able to get much traction because simply because they are predominantly using.
The LTI and does that represent sort of an incremental opportunity for you to begin to compete just because they expressed a preference for that delivery system and then I have a follow up.
Yes, absolutely Doug.
Hey.
The use of <unk> E.
Is high in all segments hospitals and clinics.
And so you know.
As we as we are enhancing our segmentation capabilities.
Dennis M. Lanfear: Well, first, I would say that I think it's a bit premature for us to comment on pricing for particular segments. I would rather have either approvals or at least confirmatory data and indications or filing for particular indications before we start talking about how we're going to go into particular segments, whether that's non-small cell or Safegio or with others. I think, though, that it is too broad, and two broad sorts of things emerge from the market.
Our intention is to be able to go very quickly into.
Those particular segments, both in the hospital labs and clinics.
And be able to demonstrate a.
Our value proposition with the.
With the <unk> versus the originator so.
We believe that that opportunity exists in all segments.
I wish I would further add Doug that.
To the question of accounts.
Definitely those accounts that will be unlocked by our own on buying that have no alternative currently.
Just but the innovator there with their device and this is the reason I mentioned that I thought there was a significant pent up demand.
Dennis M. Lanfear: In the very long run, I think that PD1s definitely will moderate in terms of pricing in the market, and that secondarily they will be replaced by, you know, doublets that are co-formulated or combination strategies, which will relieve a little of the pressure on the therapeutic stack and the pricing of the therapeutic stack, which is probably not sustainable in the longer term. But if you let us get a couple of rules and a few other submissions under our belts, we'll be happy to talk a little bit more about our strategies and how we intend to get into each of these markets. Now, let me take your last question.
Great Great. That's very helpful and just in terms of Lucentis Biosimilar is your focus going to be going after some accounts that might be predominantly uses it like we are.
Or are you going to be.
Focusing across the entire market or we'd be focusing primarily.
Sort of high volume with fantasy users. Thank you.
Oh, you wouldn't take a shot at that one sure.
We see the whole bedroom market as an opportunity obviously.
The short term as being able to.
Rapidly.
Capture share from the innovator lucentis, that's the that's the low hanging fruit, but we believe.
So what we are understanding about this marketplace where.
Pricing and contracting in values is extremely important it will be able to deliver a value proposition.
McDavid Stilwell: I'll let McDavid chime in on this one. I think it was about profitability in 2023 and how we see that evolving and so on. So, McDavid, do you want to take that one?
That will be able to enable us to compete within the within the entire VEGF work.
Okay, great. Thank you.
Your next question comes from the line of Jason <unk> of Bank of America. Your line is open.
Hey, guys.
McDavid Stilwell: Yeah, yeah, thanks for the question, Ken. We will recognize it for a long time. that 2022 would be a transition year between Eugenica sales exclusively and a, you know, a fully diversified portfolio, which will be up and running, we believe, in 2023. So we're managing coherence efficiently toward the near-term launch of four new brands, as well as the on-body injector for Eugenica. And I'll remind you that, you know, our commercial organization is already operating at scale, and so new launches don't require de novo construction of commercial operations, and we believe that additional revenue will drop quickly to the bottom line.
Thanks for taking the question.
Just wanted to get your perspectives on this Eli Lilly pivot ad com.
In your ultimate views it sounds like there's a growing consensus view that maybe the fda's tone is changing here with respect to accepting China only phase III studies.
So just sort of curious how you think about that nuance with the different potential filings with toward pallium add and ultimately do you think there's anything materially different about your program versus some of the other.
PD ones that have been studied and developed a primarily in Chinese subjects and then just a quick one on the Neulasta on body program. Just if you can talk a little bit about any.
McDavid Stilwell: So in 2023, the fully diversified portfolio should be online, and, you know, we'll have four biosimilars, including Udenica with multiple different presentations, the OBI giving it the second wind, as well as Tora Palomab approved for, we believe, multiple different indications that year. So, you know, 2023 is setting up to be a very exciting year. 2022 is a year where the story will be coming together. I would further characterize 2020 Ken as having perhaps modest increases and expenses.
Thoughts on how this plays out in terms of rollout.
Dissipate any sort of IP patent.
The challenge thanks.
So let me take the first one first.
So with with respect to other teams programs both of these programs or others.
We haven't.
Taking a deep dive into their clinical is a reviewed their data or of course not reviewed their FDA correspondence. So we're not in a very good position to to comment except I can say that.
Stang is that.
Really what's until that.
Most likely we'll have netcom to review data.
Can also tell you though that.
McDavid Stilwell: As David indicated, there's a lot of leverage that we're going to exploit going into oncology between Udica, Boston, biosimilars, and the PD1, but potentially substantial increases in revenues as we've all launched. So I think 23 is a year that'll shape up quite well.
With our own communications with FDA and propel met with nasal pharyngeal.
We will not have an AD com, we've had communications with FDA.
We'll not be required for our indication.
Now I think that the overarching color.
Color here is that a number of products have shown up in the FDA, probably is going to take the opportunity to make thorough reviews of the data, but overall I think we're pretty familiar with the types of conditions that the FDA looks at and what they impose.
Operator: Your next question comes from the line of Chris Schott of J.P. Morgan. Chris, your line is great.
Christopher Thomas Schott: Great, thanks so much for the questions. Just two on Eugenica.
They must have for example, similar standards of care with respect to the cold therapy, you have to catch the patients at the same progression disease, if it cant be any significantly genetically driven histological differences and so therefore the results are highly generalizable and then lastly, which I think is very important studies.
Christopher Thomas Schott: Maybe first just elaborate a bit on sequential trends as we think out to 4Q. It sounds like you're expecting modest volume growth for the market next quarter, but can you talk a little bit more about the competitive landscape and sequential price expectations? Is there more of a mixed shift away from 340B, etc? I'm just trying to get my hands around.
To be conducted in a very rigorous fashion with cgmp is consistent with FDA standards.
We think that would be.
In June she code here.
All studies.
And for them to all of those conditions and our strategy here of course is just with MPC as you know once we get the data will go forward to the FDA will review with them and we'll discuss the registration strategy.
Christopher Thomas Schott: Can we think about Eudica kind of at a floor this quarter, or is that a business that could continue to sequentially erode from here? And then my second question was just about the on-body product, so we think about that launch over time. Is there an ability to differentiate pricing for that product versus the existing format, given the different competitive landscapes between the two products? Or is this really more of a volume play going after that 50% of the market that's still? is sitting with OnPro.
Once we have those conversations will come back and chat.
Got it and then I guess just the on body one follow up.
Yes.
Are you wondering about it.
Exactly what part of the body.
Just do you.
Yes timing market access are you anticipating any sort of legal patent barrier at all to market access.
Oh sure yeah. So.
I would say that the.
<unk>.
We have certainly thoroughly considered.
All the IP that's out there with respect to.
And body and so forth and how to do this we totally respect on body.
Christopher Thomas Schott: Thanks so much. Thanks a lot, Chris. With respect to the sequential insights or a quarter, I'll put that one over to Paul Reader, if you get any comment on that call. Yeah, thank you.
Respect.
Intellectual property, whether it's ours or whether it's other folks and given all of that we expect to launch our on body program in Cortland right. So I think that we've been very very thoughtful about the intellectual property it won't dive into specifics of it but there is IP out there and I think it has to be observed.
Okay. Thanks, guys.
No problem.
Paul Reider: Yeah, so, obviously, our strategy is to maximize long-term endic revenues, and we're going to continue to balance the trade-off between price and share by customer and competitor, you know, as the competitive intensity heats up, and likely new competitors come in in 2022. So we're going to take a very careful, you know, review of that over time. You know, again, we're going to be focusing on Alaska, which is the largest source of revenue and opportunity for us moving forward.
Again to ask a question. Please press star one on your telephone keypad again.
One on your telephone keypad.
Our next question comes from the line of <unk> <unk> of Barclays. Your line is open.
Hi, good evening and thanks for the question.
Just one from me.
Johnny you have in the past spoken out fab, four and rectify that million dollar opportunity far Biosimilar you might.
Assuming a 10% share in the $4 billion to $5 billion market.
Comtech is working on interchange or any or a couple of them already have.
Do you think that that is the reason for us to revisit those assumptions in light of these developments and B would you want to work on interchange and ready ourselves or argue lastly.
Paul Reider: And we're going to be looking at, you know, really those higher margin, higher value segments, which are, you know, the clinic and the non-340B segments, which, as we demonstrated in the third quarter, we grew that clinic business and held firm under intense pricing competition and non-340B. So, you know, that's going to continue to be our focus. You know, I think it's reasonable to assume, with competitive pricing pressures, some continued price declines in 2020, with some moderation of that in the mid and long Let me take the question with respect to OBI that you had, Chris, if I can give you some out there.
Lastly, I think maybe just takes operating this to the profitability in 2023, how much when they might not come on community are.
And yet external clients. Thank you.
Thanks, a lot for the question with respect to the impact of interchange ability on the Humira Biosimilar market I'll, let Paul take a shot at that Paul.
Thanks for your question so interchange.
Interchange ability is subject to state pharmacy laws and so far.
It's not been a requirement to support any biosimilar adoption.
Which has been.
Quite significantly over the past several years.
We believe that payers will be the primary determinants product selection.
And that they have to formulary utilization controls.
Forced their formulary choices.
Their regular practice.
<unk> product categories today, and given the payer standpoint.
Dennis M. Lanfear: The first thing I would say is that after our announcement, the successful P.K. Which, by the way, I think is the really pivotal part of the development program that is the most difficult to pull off. Actually, conceiving a device, manufacturing, testing, and having to demonstrate its similarity with respect to pharmacokinetics, I think, is the tough thing.
Utilization of these formulary practices to drive the switch we don't change.
Change ability is an essential feature for commercial success.
Given given that anywhere.
Sure.
Sure.
We think there's we think there's sufficient.
Payer power in the market to impose their formularies.
And so we don't see that as a substantial impediment so forth with respect to the actual contribution in 'twenty three 'twenty four 'twenty five.
Dennis M. Lanfear: You know, after that, you're in the business of filing and prosecuting the case for case approval. But since we've made that announcement, it's become very clear to us that there's really significant pent-up demand in the market for non-bodies in the hands of a biosimware company such as Eugenica. So I think we're pretty optimistic about that and how it's going to move. Just how we're going to price that and what our strategy is for penetrating the market, how we're going to develop a holistic value proposition, you know, such as we did when we first came out with the pre-filled syringe.
We will leave that one for another day as opposed to shrink from that.
Thank you.
Thanks Blaine.
There are no further audio questions at this time I will now turn the call over.
Okay.
Yeah.
Thank you I just wanted to take the opportunity just for.
For a brief recap I think we've made some excellent progress with our programs so the past quarter.
Great through with all the things we've done with <unk>.
Census, biosimilar.
Tomorrow Biosimilar, the Toro palmette application and so on.
Thank you can look forward to additional progress from the company. We of course very excited about our progress with our on body system, which as you know we all worked on for quite a bit. So we look forward to catching up with you guys all at.
Ed.
Dennis M. Lanfear: I'm going to leave that for a little later down the road when we actually have that device approved in hand. We'll be happy to talk about it then, as opposed to talking about it now. But I would note the very significant sent up demand for an entitlement.
The analyst meeting, which we think is going to be sometime in mid to late January at this point. So thanks for joining us today.
This concludes today's conference call. Thank you for participating goodbye now disconnect.
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Operator: Your next question comes from the line of Douglas Chow of H.C. Wayne Wright, your line is open.
Okay.
Yes.
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Yes.
Yes.
Douglas Dylan Tsao: One, Denny, in terms of the Udenica business, I'm just curious, once you eventually get your on-body device to the market, do you anticipate that will largely be going to the current Udenica book of business, or from an account basis, will this represent an opportunity to really sort of penetrate accounts where you haven't had as much penetration to date? Hey, Doug, great question. I'll punt that with Paul.
Okay.
Sure.
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Paul Reider: Paul, what about the segments in the accounts for your onboarding? Yeah, thanks for your question, Doug. No, we see that the approval and launch of our on-body device, you know, enables us to go after that 50% of your last OBI. So that's really the strategy we're going to take on approval. And that's where the opportunity is. So we see it really being a play to capture more share of the on-body market
Yes.
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Yeah.
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Okay.
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Paul Reider: I guess Paul was asking me, "What I'm trying to understand, though, where the on-body market exists, I mean, are there sort of clinics or hospitals, etc., where you just simply haven't been able to get much traction just simply because they're predominantly using the OBI, and does that represent sort of an incremental opportunity for you to begin to compete, just because they expressed a preference for that delivery system?" And then I
Douglas Dylan Tsao: Yeah, absolutely. Yeah, Doug, I mean, the use of on-body is high in all segments, hospitals, and clinics. And so, you know, as we are enhancing our segmentation capabilities, our attention is to be able to go very quickly into those particular segments, both in the hospital and the clinic, and be able to demonstrate a different value proposition with Udenica OBI versus the originator. So we believe that opportunity exists in all segments.
Douglas Dylan Tsao: I would just further add, Doug, that there's the question of accounts; definitely, there are accounts that will be unlocked by our own on body that have no alternative currently, you know, just put the innovator there with their device, and this is the reason I mentioned that I thought there was a significant end of demand. Great, that's very helpful, Denny. And just in terms of the Lucentus biosimilar, is your focus going to be going after some accounts that might be predominantly users of ILEA, or are you going to be focusing across the entire market, or would we be focusing primarily on sort of high volume Lucentus users? Thank you. Paul, you want to take a shot at that one? Sure, Doug.
Paul Reider: Yeah, I mean, we see the whole VEGF market as an opportunity. Obviously, the short term is, you know, being able to, you know, rapidly capture share from the innovator Lucentis. That's the low-hanging fruit. But we believe, based on what we understand about this marketplace, where, you know, pricing, contracting, and value are extremely important. be able to deliver a value proposition that will be able to enable us to compete within the entire VEGF
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Operator: Your next question comes from the line of Jason Gerberry of Bank of America. Your line is open. Hey guys.
Jason Matthew Gerberry: Hey, guys, thanks for taking the question. I just wanted to get your perspectives on this Eli Lilly-Tivet adcom in your ultimate views. It sounds like there's a growing consensus view that maybe the FDA's tone is changing here with respect to accepting Chinese only phase three studies. And so, just sort of curious how you think about that nuance with the different potential filings with Thoropalumab. And ultimately, do you think there's anything that's really different about your program versus some of the other PD ones that have been studied and developed primarily on Chinese subjects?
Jason Matthew Gerberry: And then just a quick one on the new last on-body program, just if you can talk a little bit about any thoughts on how this plays out in terms of rollout and whether or not to participate in any sort of IP or patent-related challenge. Thank you. So let me take the first one first on this one team.
Dennis M. Lanfear: So with respect to other teams, programs, Lully's programs, or others, you know, we haven't taken a deep dive into their clinicals or reviewed their data or, of course, not reviewed their FDA correspondence. So we're not in a very good position to comment, except I can say that the understanding is that Lily with Centillameth will most likely have an adcom to review data. I can also tell you, though, that with our own communications with FDA on TOROPALMeth with nasal pharyngeal, we will not have an adcom.
Dennis M. Lanfear: We've had communications with FDA, saying that an adcom will not be required for our indications. Now, you know, I think that the overarching message here is that a number of products have shown up, and the FDA probably is going to take the opportunity to make thorough reviews of the data. But, you know, overall, I think we're pretty familiar with the types of conditions that the FDA looks at and what they impose. For example, they must have, for example, similar standards of care with respect to cold therapies. You have to catch patients who have the same progression of disease. There can't be any significantly genetically driven histological differences, and that, you know, so the results are highly generalizable.
Dennis M. Lanfear: And then, you know, lastly, which I think is very important, the studies have to be conducted in a very rigorous fashion with CGMPs consistent with FDA standards. And we think that the Junchi code here, as civil studies, conforms to all those conditions. And our strategy here, of course, is just with NPC, is once we get the data, we'll go forward to the FDA, we'll review it, and we'll discuss the registration strategy. And so once we have those conversations, we'll come back here. Got, and then I guess just the armed body one is the other follow-up.
Jason Matthew Gerberry: Yeah, were you wondering about exactly what part of the body? Just as you anticipate, you know, timely market access, are you anticipating any sort of legal patent barrier at all to market access? Oh, sure. Yeah.
Dennis M. Lanfear: So, you know, I would say that the team has thoroughly considered all the relevant IP that's out there with respect to OnBody and so forth and how to do this. We totally respect OnBody, respect intellectual property, whether it's ours or whether it's other folks. And given all that, we expect to launch our on-body program, according to. So I think that we've been very, very thoughtful about intellectual property. I won't dive into the specifics of it, but there is IP out there. and I think it has to be observed.
Operator: Again, to ask a question, please press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. Your next question comes from the line of Balabu Prasad of Barclays. Your line is open.
Balaji V. Prasad: Hi, good evening, and thanks for the question. Just one from me.
Balaji V. Prasad: Danny, you have in the past spoken of a $400 to $500 million opportunity for Biasmila and Umaira, assuming you're a 10% share of a $4 to $5 billion market. Now, with your competitors working on interchangeability, or a couple of them already have, do you think that there is a reason for us to revisit those assumptions in light of these developments? And B, would you want to work on interchangeability? for yourself, or not? Lastly, I think maybe just extrading this to the profitability in 2020, how much would you might contribute in your internal plans?
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Dennis M. Lanfear: Well, thanks a lot for the question. With respect to the impact of interchangeability on the Humira-Boussela market, I'll let Paul take a shot at that. Yeah, thanks for your question.
Paul Reider: So, you know, interchangeability is subject to state pharmacy laws, and so far, it's not been a requirement to support any biosimilar adoption, which has been quite significant over the past several years. We believe that payers will be the primary determiners in product selection, and that they have the formulary utilization controls to enforce their formulary choices, their regular practice, and multiple product categories today. And given the pair's stance on the utilization of these formulary practices to drive the switch, we don't view interchangeability as an essential feature for commercial success.
Paul Reider: Given that, Denny, you want to? Yeah, no. I think there's sufficient payer power in the market to impose their formularies. And so we don't see that as a substantial impediment and so forth. With respect to actual contributions in 23, 24, 25, I think we'll leave that one for another day as opposed to shooting from that.
Operator: There are no further audio questions at this time. I will now turn the call over to Jenny Lanfier.
Dennis M. Lanfear: Thank you. I just want to take the opportunity for a brief recap.
Dennis M. Lanfear: I think we've made some excellent progress with our programs in the past quarter. We're bearing great fruit with all the things we've done with the Lucentus Biosimilar, the Maira Biosimilar, the Tora Palmaab application, and so on. I think you can look forward to additional progress from the company. We're, of course, very excited about our progress with our on-body system, which, as you know, we all worked on for quite a bit. So we look forward to catching up with you guys at the analyst meeting, which we think is going to be sometime in the mid-to-late So thanks for joining us today. This concludes.
Operator: This concludes today's conference call. Thank you for participating. Goodbye.
unknown: and I'm gonna be able to be. I'm gonna be on the and I'm gonna be on the and the other, and I'm gonna be on the other, and I'm gonna do you know, I'm... I'm gonna be able to be. I'm gonna be able to be Bhopal.
unknown: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, Bhopi. Thank you.
unknown: Thank you. Thank you. Thank you, Thank you, and Thank you. Thank you. Bhopes.
unknown: Thank you. Thank you. Thank you. Thank you. Thank you. Bhopes.
unknown: Thank you. Thank you. Thank you. Thank you.
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