Coherus BioSciences Inc. Q1 2023 Earnings Call
Yeah.
Good day and thank you for standing by welcome to the call here Biosciences Q1, 2023 earnings call. 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 this session you will need to press star one one on your telephone you will then hear an automated message and I think that your hand is raised to withdraw your question. Please press star one one again.
Please be advised that today's conference is being recorded I would now like to hand, the conference over to your first speaker Mark sure Suski of Investor Relations for coherent co here. It's Biosciences. Please go ahead.
Thank you Crystal and good afternoon, everyone and thank you for joining us.
We issued a press release earlier today announcing our financial.
Actual results.
First quarter of 2023.
The release can be found on the coherent Biosciences website and it's also on cash to work for them.
Today's call includes forward looking statements regarding <unk> current expectations about future events.
These statements include but are not limited to our ability to gain approval for a multiple new products launched in the ability of the F. D. A to complete all required inspections in China.
B O life retarded allomap necessary for approval expectations about demand.
Our ability to gain market share for any of our products, our expectations about future revenues and expenses.
And the timing of any return to profitability.
All of these forward looking statements involve risks and uncertainties that are beyond our control and could cause actual results performance or achievements to differ from those implied by forward looking statements.
These statements are not guarantees of future performance and are subject to substantial risks and uncertainties are discussed in our press release that we issued today as well as the documents that we filed with the FCC.
Looking statements provided on the call today are made.
We undertake no duty to update or revise any forward looking statements.
First quarter 2023 results are not necessarily indicative of results for future periods.
With me on today's call aren't anywhere near our CEO .
Doctor. It's are you talking about Q2.
An officer, Dr. Raj Dyer, Chief Medical Officer, All Reeder, Chief commercial officer, and Mcdavid Stilwell, Chief Financial Officer.
I will now turn the call over to Dan.
Thank you Eric and thank you all for joining us on our Q1 2020 should be cool.
You want to set the stage for revenue growth over the rest of the year.
We plan for and execute multiple product launches across our diversified pipeline.
2023.
Transitioning from a single product company.
<unk> products are presentations.
Our first immuno oncology agent.
This quarter, we executed strongly on the launches and the growth catalysts or emerging pipeline.
April .
Man is now increasing that was expected.
Mechanical auto injector, it's not ready for launch later this month she driver for market share increase this year.
We're ready to launch a separate our humira biosimilar in July .
And all the requisite approvals.
Inventory.
Manufacturing facility inspection to support our Palomar.
It is now scheduled for later this month.
We expect the approval and launch of new Tenneco on body injector later in 2023.
Strengthening the franchise, especially driving additional share gains.
Following my opening remarks, all reader, our chief commercial officer will update you on the impact of the CMS is trying to call it out separately starting.
Starting the second quarter.
This back to drive sales starting in Q2 accelerate revenue growth throughout 2023.
Oh, and then further update you on the Q1 2020, where you've got like yourselves.
Sales in our launch plans for our newly approved okay.
Auto injector.
Doctor Truthful, a valley, our Chief Development Officer.
To update you on the status of the torque Palomas inspections, BLA review and our progress on bringing Tory manufacturing to the U S along with other pipeline developments.
Chief Medical Officer, Dr Raj diets well.
I will then update on our new clinical data.
As well as progress on our Ginger Palomas combination studies and our Iot short program.
As you know we've been very tightly focused on actively managing expenses without jeopardizing our product sales potential.
David Stilwell, our Chief Financial Officer, who will provide you some additional detail on measures taken during Q1 to reduce operating expenses sharpen our focus on ensuring the success of our product launches key revenue drivers, we anticipate we've turned the company.
The ability 2024.
With that I'll turn the call over to Paul Reader, our Chief Commercial Officer Paul.
Thank you Debbie good afternoon.
Mind, you with an update this afternoon on the expansion of our commercial product portfolio.
The potential launches of products 2023, we expect drive topline revenue growth each year going forward.
Start with similarly fully interchangeable Lucentis biosimilar launched in the fourth quarter.
Our strategic approach to the market first maximize the conversion.
We started this business, which currently represents 1 billion units annually and second grow share through new patient starts for <unk>.
<unk> from other anti VEGF products.
All the complete label with interchangeability, it's been well received by retinal specialists, giving them the confidence they can safely transition currently treated lucentis patients. Similarly expect the same clinical outcomes.
The miscellaneous J code is hindered adoption and conversion.
Yeah like under a miscellaneous code is prone to errors disrupting payment flows even if executed correctly.
The payment delays are too much more.
Shrubs practice cash flows.
Do you expect it to slow or sport separately sales till the activation by CMS.
A permanent product specific Q code, which enables electronic automated billing.
Providing faster payments with much higher search.
Accordingly, we focused our efforts in Q1 cheating the permanent J code from just a few minutes.
I'm getting it deployed across ophthalmology practices and Payors.
Those efforts are bearing fruit.
The pair front as of April 30th over 90% of Turkey, Paris for Luna.
With respect to billing and reimbursement do you think the Q code.
Providers have reported receiving full reimbursement.
14 days of electronics.
We are now seeing the expected increase in demand.
The month of April we've shipped over 7200 demands, which represents about 72% of the entire Q1 2023 unit sales.
Also during Q1, we doubled the number of accounts ordering similarly to 185.
Those 54% every quarter.
Among these ordering accounts similarly market share was 20%.
He enforced to potentially similarly once accounts begin adopting.
As momentum built in Q1 prior to deploying the Q code.
This helped fuel the doubling up to manage what salting at an average rate of just about market share for the quarter of four 1% compared to two 4% in the prior.
Begun to normalize for the first quarter sales of similarly, with $6 2 million compared to $6 95 billion.
I'll now turn to our oncology franchise, starting with your Deneke the launch plans for the two new presentations.
As you know the pegfilgrastim pre filled syringe as increasingly competitive.
As reflected by continued price erosion.
Our strategy is not to compete solely on price, but to launch additional presentations to provide a differentiated value proposition to patients and providers filling an unmet needs in the market with.
The objective to regain share.
The past year, we told you you would sacrifice sure to preserve pricing power for these future presentation margins.
As all product presentations are linked to the same average selling price and we maintain a strong ESP, which to launch our two new <unk>.
Innovative presentations.
We plan to watch Jessica Auto injector later this month.
This presentation represents the first innovation and depicts progressive class eight years customer receptivity has been overwhelmingly positive.
This confirms that there is a large market segment unserved by Neulasta on.
The on body device, which still retains 43% of the March.
<unk> auto injector provides convenience administration flexibility independents and certain delivery under 10 seconds.
Auto injector, thus provides providers and patients a highly desired alternative.
It has the potential to drive market share increase over the coming quarters.
Q1, 2023 was our last quarter competing with one undifferentiated presentation through.
<unk> net sales were 26 billion.
<unk> from the prior quarter, resulting from four key factors.
First a market share decline of 1% from the prior quarter to 11, 5%.
A 9% decline in net selling price required to maintain a competitive position to pre filled syringe segment.
Wholesale inventory levels at the end of Q4, which now normalized.
Finally, a nonrecurring $1 $7 million charge, resulting from a contingent liability horizon.
Yeah.
Going forward, we believe eugenic franchise is well positioned to regain market share.
In the second half of 2023.
Dedicated is now the only Pegfilgrastim brand, both Prefilled syringe and the auto injector.
Later this year.
Beyond body on body injector, it's approved we will be the only pegfilgrastim brand with all three product presentations.
This will provide a path to Max Smith market penetration and market share growth this year.
We expect our next oncology launch to be toward Palomar.
Bruce.
Let me cover some of our large stocks.
Watching the company's first immuno oncology product is a critical step for the advancement of our buying power.
Our mission is to extend the cancer patients.
And to offer new hope to patients and nasal pharyngeal car stupid excellent example.
Good day Mtc patients have no FDA approved treatments, including Io therapies, and therefore constitutes a high yield.
Torre <unk> next generation <unk> inhibitor different proof will be the first and only PD one inhibitor in the U S indicated for relapsed metastatic nasopharyngeal carcinoma <unk>.
Establishing a new standard of care all lines of therapy, including first line.
As such we feel confidence toward Palo <unk>, plus chemo will gain a dominant market share estimate the MPC market opportunity could reach $200 million.
Preparation for toward Palo <unk> virtual launch we are executing on a number of prelaunch activities.
Created and launched NPC facts Dot com.
It was designed to be a primary source of disease state information for patients and their caregivers to learn about.
Sister site for health care professionals also launched.
MPC fact stock comp space.
<unk> and their caregivers to join our community, enabling us to share disease State education that is tailored to each patient at each stage MPC mpc's progression.
Our aspiration.
To identify and appropriately engage with OLED PC patients U S.
Okay.
We continue to train our oncology sales so they will be ready yet launch to educate doctors, where <unk> differentiated mechanism of action and the impressive patient survival.
Demonstrated at MPC irrespective of PD lone expression status.
Finally, we will launch a peer to peer educational program.
During the nation's leading opinion leaders and field in head and neck cancers.
And we look forward to engaging with these kols at the upcoming ash.
While some modest marketing investment will be required to identify patients and educate physicians and providers on the benefits we're appealing that.
Ecology commercial capabilities, we're built for scale.
Significant overlap between your direct customers and toward Palomar targeted prescribers.
Therefore at the launch Tory Palomar is being efficiently integrated into our existing oncology commercial infrastructure.
We are ready to launch towards <unk> product approval and expect to successfully address the entire patient population.
Cross all lines of therapy.
Irrespective of PD lone expression status.
I'll end with you separately, our Humira Biosimilar, which is on track to launch in July .
Argued feedback confirms that price robust supply and product presentation.
The key criteria used to making formulary decisions. When you sebree is well positioned to compete on each of these criteria.
<unk> will have a state of the art auto injector presentation.
<unk>, our proprietary non stick to treat pre formulations into 2009 gauge needle.
Sure.
We will have substantial supply volumes in March with hundreds of thousands of two separate units.
Sure.
We are confident in our ability and our commercial approach and we look forward to updating you in more detail on our strategy.
August call after we launch.
In summary, we are now function point of our growth story.
<unk> ongoing new product launches and drive top line revenue.
Yes.
I'll now turn the call over to Teresa Labelle.
Thank you Paul and good afternoon, everyone let.
Let me begin with an update on our tour appellate Nab inspections and projected approval.
Yeah, Colby travel restrictions in China.
You said, Dave Smith for Tomorrow, Palo, Matt MTT application in December 2022.
In January the travel restrictions related to COVID-19.
And then Mike were eliminated.
Expansion is scheduled.
Second.
Okay.
We wish to thank our partner <unk> Biosciences.
Thorough and diligent preparation efforts.
The inspection.
With respect to that.
The clinical data.
The BLA.
We know the.
FDA granted.
And that breakthrough therapy designation.
There are no.
Treatments.
Agency has consistently recognized.
Matt.
It's David.
Warheads regulatory flexibility.
Hey, Brian .
It's Darren.
Complete.
The FDA does.
Ramon great rhetorical clinical assessment.
Hey, Jennifer.
Yeah.
We continue to work with the FDA.
The clinical site inspection.
Or a Palo Matt is the next generation PD, one with a differentiated mechanism of action.
<unk> demonstrated.
Survival benefit in multiple tumor types in combination with chemotherapy.
PDL.
Yes.
Based on these observations we can get that.
Mechanistic studies.
Better understand the basis of this differentiation.
We have just completed preclinical studies for journal submission demonstrating that for Apollo.
As higher potency on T cell activation compared to peers.
These data further support the evolving understanding appeal that PD, one antibodies are not open.
Alright.
Or necessarily.
And we plan to present, our findings at a time.
In later this year.
We believe that this makes our Apollo.
Foundation for Io pipeline as well as a combination agent.
Garrett.
Yeah.
Thus, we are actively seeking additional development opportunities to expand our Apollo b.
Dan.
This combination of Dr. Diane as Bob described.
I'm also pleased to report that.
Sharon its Brad.
Factoring in the team.
Execute at a very high level.
In the first quarter.
Results for the summary, auto injector as well as the facility change for large scale manufacturing.
Additional results.
Devin check your presentation.
Fourth quarter.
Quarter.
We have Dennis have BLA supplement to the on body injector presentation is progressing well and we look forward.
Sure.
Lastly regarding tech transfer of Tomorrow Allomap manufacturing.
Dave.
I can report that we recently successfully.
The large scale engineering runs EBIDTA score.
Goodbye.
We plan to execute the process qualification Rod this fall and have prioritized efforts.
I'll now turn it over to Dr. Raj <unk>, our Chief Medical officer for a clinical update on the coherent Io pipeline.
Raj.
Thanks, very much Teresa and good afternoon, everyone.
Alright, Palomar continues to form the backbone of our French.
Franchise.
Believe that the application of pivotal data across nasopharyngeal carcinoma, non small cell lung cancer, and esophageal squamous cell carcinoma in top tier journals.
Are you doing positive data sets being released across multiple tumor types together with its differentiated mechanism of action.
Tory pattern that effectively as a partner of choice for combinations.
Several Tory piling that dataset across multiple tumor types and tumor settings have been accepted for presentation at the upcoming <unk> 2023 annual meeting.
These data for non small cell lung cancer with final overall survival and biomarker analysis choice zero, one first line non small cell study.
As well as event free survival data from near towards in the Peri operative treatment of stage two three months.
Handset.
Metastatic or recurrent triple negative breast cancer PFS data will be presented for the torch light study.
We will also be presenting the final overall survival analysis of zero to a registration study in the first line treatments recurrent or metastatic mtc on Monday June <unk>.
Sure It is clinically and statistically significant results.
This will build upon the positive progression fee survival data nature.
Nature Medicine in 2021.
2021 ask a plenary session and which form the basis of our BLA submission date.
With respect to our internal pipeline, we remain excited about our phase 128 Panamax study.
Currently active in the U S anticipated.
Patient results next year.
In addition.
<unk> asset remains on track as we proceed towards R&D submission towards.
Towards the end of this year.
I'll now turn it over to David <unk>.
Our Chief Financial Officer.
Thank you Raj.
Today, we reiterate our prior financial guidance for 2023.
Revenue growth from accelerating separately sales and the launches this year of towards Pelham at Sebree, and <unk> auto injector and on body injector.
For the full year, we expect to book at least $275 million in net sales with at least $100 billion. Similarly net product revenue.
In the first quarter, we took measures to reduce operating expenses with a reduction in force and the re scoping of the Tory combat joint development.
Along with other measures we implemented last year, we have significantly reduced expected 2023, R&D and SG&A expenses to a range of $315 million to $335 million.
This range excludes nonrecurring milestones and upfront payments and it includes approximately $50 million and noncash stock compensation expense.
Here at the start of the year, we requested and obtained a waiver for the revenue covenants of our term loan through the first two quarters of 2023.
Recognizing that similarly acute care would not be available until April one and.
In a few deneke auto injector would not launch until may.
For my review today, our first quarter financial results I'll touch on just a few highlights and the details are in the press release 8-K and 10-Q, we filed this afternoon.
Net loss for the first quarter of 2023 was $75 $7 million 96 per share.
On a diluted basis compared to a net loss of $96 1 billion or $1 24 per share on a diluted basis for the same period of 2022.
We incurred approximately $4 9 million to nonrecurring charges in connection with the restructuring in March 2020.
Net revenue for the first quarter 2023 was $32 4 million and included $26 $2 million and sales of Tenneco and $6 2 million net similarly.
Net sales of <unk> were reduced by $1 $7 million charge for a contingent liability related to resolving SKU.
Net revenue declined compared to the same quarter on year ago, primarily due to a decrease in the number of units or <unk>.
As well as the lower net realized price.
Cost of goods sold was $16 $9 million during the first quarter of 2023.
I recall that your deneke Cogs includes a mid single digit royalty on net sales payable through the first half of 2024, and similarly Cogs includes a low to mid 50% loyalty on gross profits.
Cogs in the first quarter of 2023 included two nonrecurring items of $3 million contract modification eight with one of our manufacturers and a $2 $7 million write off of inventory.
During processing is one of our manufacturers.
Research and development expense for the first quarter 2023 was $34 2 million significantly lower than the year ago quarter, when we reported $47 $9 million and R&D expenses.
After excluding a $35 million license fee paid to <unk> biosciences for the ticket and CHS series six.
R&D expense for the first quarter 2023 included $3 $6 billion and costs associated with the recent reduction in force.
Selling general and administrative expense for the first quarter 2023 was $49 2 million.
Roughly equivalent to the $48 $8 million SG&A expenses for the same period in 2022.
SG&A expenses are primarily driven by commercialization activities to support current you deneke separately sales and costs incurred in preparation for multiple anticipated new product launches in 2023.
SG&A expense for the first quarter 2023 included $1 3 million in costs associated with the recent reduction in force.
Cash cash equivalents and investments in marketable securities were $128 $1 billion as of March 31, 2023.
Two $191 7 billion at year end.
Cash burn was elevated in the first quarter of 2023 by head count related costs specific to the quarter and was further impacted by introductory payment terms for the <unk> launch, which delayed cash receipts for product sales, we expect the timing of cash receipts to normalize in the second half of the year.
In 2023, we're focused on ensuring the success of our new product launches and generation of the anticipated revenue growth.
We'll continue to maintain tight control over our operating expenses as we aim toward a potential return to profitability in 2024.
I'll now turn the call back to Denny.
Thank you David and thank you all for joining us on our Q1 2023 earnings call.
Now lets assembly Q code that we're beginning to see the impact for the second quarter, we look forward to accelerating some early sales throughout the year.
I mean, you did a confront a launch later this month.
Our product presentation, eugenic auto injector provide patients and physicians with a unique option differentiate and Jessica and the pegfilgrastim market share.
Share gains.
Development of our immuno oncology franchise is progressing well.
Sure Palmette foundational asset and anchored continues in study after study demonstrated strong efficacy and safety across multiple tumor types.
For the next generation PD, one physicians closure outside Chile as the partner of choice for those developing combination treatments with their own proprietary agents and number of cancers.
But the manufacturing inspection scheduled this month, we are optimistic that approval in the first indication is a pharyngeal cancer will occur in Q3.
Lastly, we.
Thoughtful and disciplined cost and expense control, we've significantly reduced our 2020 expenses by about $100 million.
To about $325 million.
We'll continue to look for more efficiencies and savings as we progress our efforts to drive revenue increases while controlling expenditures achieved profitability 2024.
Operator, we're ready for questions.
Thank you.
At this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again, please standby, while we compile the Q&A roster.
Our first question comes from the line of Robyn <unk> with Securities. Your line is now open.
Hi, Thanks for the question and congrats on getting the manufacturing inspection.
Great News.
Two sets of questions I'll be really brief on Tory. It seems like there was a press release released by your partner Tinchy around small cell lung cancer, which has typically been very difficult to treat with checkpoint inhibitors, given the cold tumors. So I had a few questions on that.
What are your thoughts on like whites, where he worked.
Given is it differentiate epitope and M away do you think is driving the response and then how does this change your overall strategy with Tory talked about partnering going forward.
Things like this would be a pretty big deal if it works in SCLC talk a little bit about <unk>.
Abbott's collaboration interest there is and how where people are at this new dataset and then I have one on identical.
Thank you Robyn.
That question, Yes, we are very pleased to see the small cell data.
Announcements at this morning, I'll, let Dr La valley addressed issues.
The mechanism of action to our Bell map now subsequently have Dr Diab and addressed.
Address your secondary question, which is the potential combinations and these other indications, including small cell therapies.
Yeah. Thanks Robin.
And yet another positive.
On study with Tory.
And particularly in a difficult market.
Benefits from other PD one antibodies.
And positive survival results are consistent with our clinical studies showing that tour empowerment has mark.
Compared to pure lithium app.
That really set up well.
Well, if you really think about combinations.
Ross expand further yes. Thanks treatment. Thanks Robin for the question. So I think you're quite right first of all again.
<unk> trends that I think there's a real unmet need here.
It represents about 15% to 20% of all lung cancers.
At this stage.
<unk> to half.
Yes.
And the current therapies that are out that continues to have module benefit so with that in mind.
We are very excited about the benefits both PFS and OS.
I think.
Co primary endpoints.
And I think if we look at the overall <unk>.
Base.
We I think this data continues to add to the breadth of the data available across multiple different tumor types. As we mentioned for lung alone we have choice zero one now.
Yes, the torch in Perry.
Operator, now small cell lung cancer, all showing positive results I do think that.
Really well for combinations.
Small cell, but also other forms of lung cancer and then also additional.
Without additional datasets.
Robin.
Remark with respect to this.
When we selected Palo Matt from a broad array of available Q1.
Some three years ago, we consistently saw an outperforming other agents such as <unk> and various in vitro in cell based studies, although we didn't quite understand all the implications of it now I think it's very rewarding first of all see the mechanism of action story readout effect to the valley indicated that's all.
Also now very rewarding to see this readout in several cancers, we're into our power map that continues as we said.
Demonstrated really.
<unk> track record here as far as efficacy.
With that I think you had a follow up question on your deneke, perhaps yes.
Colin I mean, given that the Asian based study I mean, I'm sure that doctors will be super excited to see the detailed data do you have any sense of whether it be in a publication or presentation on that and the identical. My question is really about the auto injector are in fact, you're going to have the auto injector the on body device and the pre filled syringe I'm just trying to get a better sense of you know.
<unk> the auto injector what are you getting as an early read on the interest for the auto injector and that being differentiated now and then you know it's really giving you a three I mean, just help us tease out like how do we think about these three product taking share in different markets. Thanks.
Thanks, that's a great question so.
I'll, let Paul a frame that out for you first of all with a differentiated value proposition is for the auto injector.
<unk> to various dosage forms which are in the market today, and then secondarily some of the progress that we're making with the payers on that front.
Hey, Robyn Thanks for your question Yeah, we're excited to launch the auto injector later this month and we expect it all.
Cause some market share stabilization this quarter and then really increased growth in the second half of the year I think with the auto injector.
Enables us to do in the market is to go compete in both the in clinic segment.
Against the competitive pre filled syringe competitors.
But it also enables us to now compete more effectively in the at home segment were on pro still has 43% sure. It will do that because of the patient benefits. There's really three important <unk> first is the auto injector will give patients or dependence over their injection experience, so essentially you'll be able to.
Inject when and where they desire and the second is ease of use.
This can be delivered in less than 10 seconds as opposed to where the body for an entire day and navigating through a 45 minute injection time and then the third is flexibility to the patients who look far away or it can come back to the office can simply do this at home. So we believe it's going to be able to penetrate all segments of the market.
Yes.
<unk> coverage is actually coming on online very nicely, where we have coverage today, we've got confirmed coverage for auto injector and over 90% of those plans. So the team is now working with customers getting it on formularies and we'll be ready to launch.
Yes.
Thank you.
Thank you please standby for our next question.
Thank you. Our next question comes from the line of Salim Sayed with Mizuho. Your line is now open.
Great. Good afternoon, guys. Thanks for the question I guess a couple from me if I can one on.
One on one on perhaps towards <unk> and then another on your Danica.
On Tory Paul you mentioned that you believe on MPC you can reach a peak sales number around 200 million I know you haven't disclosed.
Youre pricing framework here, but by my math that would suggest something about $85000 net price per patient just curious if you could.
Pointing in the right direction.
Ballparkish correct based on your 200 million RFP, if you were to actually be able to get into all patients all lines.
Yes.
Yes, let me take that one.
As a matter of policy, we don't comment on pricing and products will turn out.
So after we have the product approved we'll be happy to revert theyre projected pricing.
But as Paul said in his remarks, and we will.
We'll have full first line.
Lines of care and we do have.
About I think 2500, plus patients per year, but we were happy to chat a little bit about pricing tool.
Okay great.
Yes.
Maybe if I, maybe if you could comment a little bit then on.
I guess I'll just ask my second question on Torrey Pines.
Maybe you can comment a little bit on the warehousing. It sounded like you guys are trying to build a registry.
Patients for MPC with your with your website.
Can you just maybe give us an idea of how many patients are currently in the registry in.
How many you plan to warehouse prior to approval. Thank you.
Yes, thanks, <unk> being a rare cancer they only.
Company and brand Thats going to be entering the space.
Launching MPC effects.
It was really the work of our core market intelligence and our customer knowledge, where we've found that doctors and patients really don't have a.
Qualified.
Centralized place to go to get information about NPC and so that was that was the real driving force there now, adding a community where we can invite patients their caregivers to join enables us to now educate them and we will understand if their local localized worth or metastatic and we can then.
Communicate with them appropriately so we're going to be turning up the media around that to really start cranking up the noise level, there will be having our field team through appropriate disease state efforts.
Sure the website with the accounts directly so they can actually hand, this out that their patients as they come in so we will be reporting out on actual numbers on that so.
So far we like we like what we're seeing here.
I would add the additional comments Helene that.
If approved we will be the only <unk> approved.
By FDA for this terrible disease, we feel that we have a responsibility.
Reach out to these patients and find these patients and educate them these patients or otherwise progressing without palomar.
And as Raj indicated benefits of <unk> power Nap treatment are really substantial and so we feel tremendous.
<unk> ability to reach out to these patients and let them know there as well.
Okay. Thank you so much guys. Thank you.
Thank you please standby for our next question.
Our next question comes from the line of Mike <unk> from TV Cowen. Your line is now open.
Thank you for the question.
On toward pallet.
And you've hinted at already a little bit, but I'm curious if you have a sense of whether there is any off label use of other checkpoint inhibitors and PC.
That you may have to displace once toward Paramount is approved I realize there is no approved checkpoint inhibitor.
And then secondly, when we think beyond MPC it would seem given a potentially differentiated mechanism of action and potentially differentiated clinical profile that the world is your oyster how would you go about selecting the next set of indications to advance into pivotal trials.
Thank you.
Mike. Thank you very much for the question I'll, let Dr. <unk>.
Address your first question and then back to the valley can address the mechanism of action questions. Subsequently.
So just thanks for the question. So I'll just reiterate a couple of points that we mentioned the festival there are no approved therapies.
Or nasopharyngeal carcinoma.
In the U S. So what that means to the current standard treatments typically chemotherapy, Jeff vitamins cisplatin typically.
That even though that is not an indication for.
For other Immunotherapies.
There is.
And Ccs does include.
A couple of other therapies.
As potential treatments, but that importantly, actually is on the basis of.
Our data set.
Fr positive dataset.
You saw that.
Yes.
Other immunotherapy and indications.
Teresa can you comment on how the mechanism of action.
It brings forward other potential combination therapies with Tory mab warehouses for.
So.
Yes.
Great.
T cells like Israeli tradable.
Can be April that debate anti tumor immunity.
Seen across three large phase III studies the MTBE.
Equates Glenn non small cell lung cancer study and the Jupiter.
The FTC study that was published in cancer cell.
That will add to our polymer and frontline study.
Combination with chemotherapy works irrespective of PDL one status.
And really lends itself to combinations to really target mechanisms of resistance.
So our pipeline.
Okay. Thank you Matt Murphy.
Yes.
This factor.
Diseases, such as small cell lung cancer.
We'll be looking at positioning.
Positioning based on that.
As we stated a few times, we're really engaged with a number of either company.
That has.
Compounds with phase two data to help us position Tory.
MTBE.
Based on our strong clinical hypothesis I think later that Sherri LPC.
So nice development there.
Thanks for your question Mike.
Thank you.
Please standby for our next question.
Our next question comes from the line of Douglas Tsao of H C. Wainwright. Your line is now open.
Hi, good afternoon, thanks for taking the questions just a.
Question on.
Similarly for me I'm, just curious in terms of the accounts that have adopted it.
Are they switching all their ranibizumab volume two similarly or are they typically still letting it between.
Similarly, and Lucentis.
Thanks for your question, Paul do you want to take that one.
Sure. Thanks, Doug Yes as of today.
Our sourcing business from a patient standpoint.
It's coming from a combination of new patient starts as well as conversions from other anti <unk>.
Jeff therapies, including <unk> so we.
We expect the desk and Thats what were seeing in the March.
Sure.
Do you have.
Do you have a following question Doug.
Also just in terms of.
<unk> launch I'm, just curious do you have a sense or have you been able to start to make some progress or finalized agreements with payers because from.
That seems to be a real focus of your strategy just given the fact that youre not going to really be promoting.
Into those indications.
I think it's fair to say that the focus of any.
Humira biosimilar market participant competitor will.
It will be payers and so far as erez.
And Pbms are the primary determinant of formulary selection for this product that being said we have also previously indicated that we won't be making.
Any comments regarding pricing, particularly their payers are conversations until after the launch in July . So that's a fair question for our August call, which we're talking about Q2.
But.
No further comment on that particular point at this point.
Okay, great. Thank you.
Thank you please standby for our next question.
Okay.
Our next question comes from the line of <unk> Prasad of Barclays. Your line is now open.
Our next question.
<unk> are you there your line is open.
Okay.
Move on to the next question operator, please come back yes, I will thank you. Please hold for the next question.
Okay.
Our next question comes from the line of Ash Verma of UBS. Your line is now open.
Hi, there congrats on the progress thanks for taking my questions I had.
Had one on Tory in London.
Your salary so our total panel maybe.
Maybe I missed this lag from Fda's point of view.
Indicated the elimination and the NBC approval, just the site inspection or does it do you still need to make up its mind, whether it will or will not.
About regulatory flexibility as it looks for.
China's target PD, one and <unk> I know that there has been.
A paper that was published in lancet couple of years ago, We made the commentary on NBC and FCC being these are indications of high unmet need.
You have like a confirmation from the FDA, if thats not an issue anymore does that apply to any other indications.
That's my first question and then I'll take you so.
So similar diesel.
You mentioned the mid single digit royalty to be paid until 2020 mid 2024, just wanted to understand if I heard that correctly is that may go.
Our industry standard cone that you got in there is no royalty that you need to be after 2024.
Just like based on your launch timeline.
Alright, let me let me take the last one first okay.
Okay.
I think David David was that we had a low single digit royalty on new deneke.
Thousand 24, not similarly.
Separately.
<unk> financial arrangement.
And which we have a royalty profit split with our licensee site slightly different if that's clear.
With regards to your question regulatory flexibility.
Let Dr Valley address the issue of what comprises regulatory and flexibility for the FDA.
The status of that.
And the consistency of their comments, particularly as it applies to FHA a treatment.
Thanks.
Yes.
Yes, it's David.
And numerate it several times.
The warrants regulatory flexibility.
And LNG article and the New England Journal.
Hudson Valley pads Sir.
And the way that they look at it.
One on the epidemiology.
If approved apparel available therapies.
Pam.
Of Clickability U S medical.
And so MPC as Glenn Beck relief, if you will.
Get out of jail free.
As far as particularly given the lack of that.
Three.
Treatment and the profound benefit.
Search with Tory Allomap in combination with chemotherapy in a frontline study in monotherapy in second and later line.
The only thing when you Miss the Paducah date without a letter.
Yes.
Okay.
Thank you Greg.
Lee about not about multichannel.
I know last year in June .
Travel restrictions.
And.
Thank you.
Yes.
Even in the proceed a couple weeks ago the FDA.
Not reinstated Dalian in China.
China.
They had told us repeatedly given the breakthrough therapy designation.
And the meaningful clinical data.
Yes.
Yes.
The fact that our scheduled this month.
Alex you were at the front of the list.
I don't think they would be using their resources.
Sure.
Places, where they had worries.
Externally and internally FDA has been very very very nice.
That nasal pharyngeal cancer orange regulatory flexibility.
Great Yes.
Yes, that's great to hear thanks. Thank you so much.
Thank you for your question. Please standby for our next question.
Okay.
Our next question comes from the line of Chris Schott of J P. M. Your line is now open.
Great. Thanks, so much for the questions.
The first one was just on your deneke.
Just trying get my hands around.
I guess flow through of the competitive dynamics for the traditional presentation.
And how insulated basically the auto injector and on body opportunities are from that so obviously companies in a much much improved competitive position with these approvals, but I guess does the more competitive environment for the traditional product impact the opportunity for the new presentations or do you view them as almost like kind of separate markets as the as we think about kind of.
Where pricing could shake out et cetera for these.
Thanks, Chris I'll, let Paul reply to your question.
Back to PFS, an auto injector presentations the competitive dynamics.
Yes, Chris So when you think about the Pegfilgrastim market is bifurcated into two segments.
In office segment, where the largely the patients come back to the office, that's predominantly been where the pre filled syringe presentations have been completed.
Auto injector.
<unk> can be used in that setting base.
Based on nurse.
And patient preference there'll be billed under the same Q code and reimbursed through the same asps. So differentiated device enables us to compete there and the other part of the next 50.
7% of the market.
<unk> segment, where on pro <unk>.
As largely had a dominant share is where the auto injector will be able to offer a new alternative.
That case it'll be on the differentiation.
The patient experience.
That the patient can realize using a simple easy to use auto injector versus where in the on body device. So.
Then when we add the big ore body if.
If approved later this year, we will have the total solution for our customers. So whether they are in the office or at home.
Whatever they are a hospital or clinic, you'll have three presentations to the unique needs of the providers of the patient. So we believe that will put us in a strong competitive position with the franchise and we will.
Enable us to grow share later this year and in the coming years.
Great. Thanks, guys.
On the auto injector versus on body I guess, those two opportunities what do you see as the bigger opportunity as it seems like one is kind of a unique presentation to cohere <unk>.
The other is obviously a large segment of the market that youll be the only kind of competitor I guess versus versus Amgen.
Yes.
We're going to launch at the end of this book.
We'll really see how come.
Customer receptivity.
Unfolds here, but we're very very excited about based on what we've heard I think at the end of the day, Chris what's going to happen. It is.
Patients are good.
We're going to choose what type of experience they want and the nurses are going to be key constituents, helping to identify which if it's the auto injector or the body.
Could a best fit so we want to be the brand that offers all three so that we're positioned strongly so depending upon whatever the patient and the doctor prescribes if you want to be the the total solution.
One additional point I would make so Chris is that.
With non body system.
As to be filled by the nurse attached to the patient activated the patient walks around with it for 24 hours, there's about a three hour period that the patient had satisfied injection and then theres, a 45 minute injection period in which the patients basically do anything.
We think that the patient of a loss of control. Your therapy is controlling you right and people are living with cancer right. So it's very attractive for a patient.
Be able to be administered with an auto injector at.
At the time of their choosing.
That's a very powerful patient empowerment.
We have seen very strong receptivity in the market to your question as to which segment I will take the most prominent.
We take share from non PFS payout body, it's a new segment, but also the PFS is generally new Unserved segment.
Great and then just one just last one from me I know you kind of comment on pricing on the Biosimilar humira side, the market launches, but just any observations or surprises or thoughts at all on the I guess the market formation. So far with the first Biosimilar Thats launched or is that generally trending as you would have anticipated for the first three or four.
And the market.
I think the.
I think it's a fair question, but I believe that the jury is out at this point I think we've only had one team launch <unk>.
The results have been made public and so I think you just have to really see.
Don't think market formation has really started for the Humira biosimilar market and don't think it will until after the July date.
Another.
Some other market entrants come in but I think thats, the point, where you're starting to see things happen.
Great. Thanks, so much.
Thanks, Chris.
Thank you please standby for our last question.
Our last question comes from the line of Jason <unk> from Bank of America. Your line is now open.
Hey, guys. This is robin on for Jason.
Two questions for me.
First one is so we've seen the first price increase for you Daniel.
In tandem with the auto injector launch should we expect to see pricing sort of steady state from here or are there more price increases to come.
As the new formats come to market and then the second question is going back to your March 2022, Investor Day, where you said 2026 targets. How are you thinking about the 10% market share goal that leads to a $1 2 billion target as you transition to the commercial launch phase.
Multiple products. Thank you.
Alright, Thanks, and thanks for your question with respect to Deneke pricing so do.
Do I understand correctly that you stated there was a price increase.
With the additional partners.
From welcome Jim.
Yes.
Oh, you mean.
Yes.
Ian.
Kurt.
Yes.
Oh, Okay, Paul could you explain the SDN, Greg, Yes, sure just to clarify.
<unk>.
List price for the auto injector will be the same price as the.
Pre filled syringe.
Which is about a 35% from 35% discount to <unk>.
Lastly, as it relates to the ASP.
You are correct that in the second quarter, we did have a 4% increase.
In our in our ASP.
Which.
Puts it amongst the highest.
Stablish brands in the class, including the innovator so higher ASP.
It leads to higher reimbursed. So that's why we've been very disciplined with management of BSP and preparation for these two presentations.
With respect to Yosemite question and market share.
I would point out that this market is developing consistent with our expectations.
One to two years ago from payers about what was important to them.
That is to say pricing scale robustness of supply the auto injector patient comfort, that's playing out pretty much as planned.
Deliberately spent about $45 million to move into very large scale manufacturing, that's an approval that Dr. <unk> and her team.
Last quarter, So I think we're.
Well prepared.
In terms of scale for competing.
10, plus percent as we go forward and just how long it takes us to get to that sort of benchmark in the market that we will have to see.
Given the dynamics.
Can say that we are totally geared up.
All aspects of that with the device with the scale and with our cost structure.
Great.
And then if I could add one follow up.
Do you have any line of sight into competitor Biosimilar Lucentis launches over the next 12 to 18 months.
Well do you want to take that question.
Yes, we are only aware of one one competitor.
Random bits about Biosimilar and from what we understand they're not looking for large till 2024 based on their public statements.
I think the key issue, though to keep in mind.
But similarly, and Lucentis biosimilar market as the impact on the Q code.
That we that we garner deployed on April one.
The opportunity in the last couple of weeks to go out and visit a number of customers and discussed with them first and whatever barriers.
The adoption there may have been.
Similarly, and so on.
And every single one of those customers, but I think I saw or different practices in four different states.
I talked to at least.
30% to 50.
Physicians.
I'm thinking within those practices and they are all areas as think about a the impact of acute code and its impact on their cash flow durability to be certain about reimbursement. So I think thats why youre seeing the acceleration in the market share and the uptake in some of the things even we've seen some.
Additional data came out today.
On April utilization, so I think that falls directly from acute code per our previous remarks, and direct feedback from our customers indicate that is the case also.
Great. Thanks, so much.
Okay great.
Thank you at this time I would like to turn it back to Denny.
In theory, the CEO of coherent biosciences for closing remarks.
Thank you operator, and thank you everyone for joining us today as you heard 2023 will be an exciting year catalysts and we look forward to keeping you all updated on our progress will be at the Bank of America Conference. This week and we'll get UBS. Following that later this month to you all soon.
Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
Goodbye.
Okay.
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