Q1 2023 Regeneron Pharmaceuticals Inc Earnings Call
Welcome to the Regeneron Pharmaceuticals first quarter of 2023 earnings Conference call. My name is Josh and that'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this.
Conference is being recorded I will now turn.
During the call over to Ryan Crow, Vice President Investor Relations you may begin.
Thank you Josh good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first quarter of 2023 earnings Conference call. An archive of this webcast will be available on our Investor Relations website. Shortly after the call ends.
Joining me today, a doctor Leonard Shleifer, a co founder President and Chief Executive Officer, Dr. Georgia on calculus, co founder President and Chief Scientific Officer.
Executive Vice President and head of commercial and Bob Landry Executive Vice President and Chief Financial Officer. After that prepared remarks, we will open the call for Q&A.
I would like to remind you that remarks made on today's call may include forward looking statements about regeneron such statements may include but are not limited to those related to regeneron and its products and business financial forecasting guidance revenue diversification development programs and related anticipated milestones collaborations finances regulatory matters are coverage Henry.
[noise] berkman issues.
Intellectual property pending litigation out of the proceedings and competition.
Each forward looking statement, a subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.
A more complete description of these and other material risks can be found at regeneron filings with the United States Securities and Exchange Commission, including his Form 10-Q for the quarterly period ended March 31st 2023.
Which was filed with the S E C. This morning.
Regeneron does not undertake any obligation to update any forward looking statements, whether as a result of new information future events or otherwise. In addition, please note the gap and non get matters will be discussed in today's call <unk>.
Information regarding our use of non-GAAP financial measures that a reconciliation of those measures to gap is available in our financial results press release, and our corporate presentation, which can be accessed on our website.
Oh, I'm, sorry, cough includes Bob Landry and the I R team will be available to answer further questions.
With that let me turn the call over to our President and Chief Executive Officer Doctor Lynch Lifer then.
Thank you Ryan and thank you to everyone joining today's call.
Following are significant achievements in 2022 Regeneron is off to a good start in 2023 highlighted by important regulatory pipeline advances commercial execution and prudent capital allocation, all of which position better the company to deliver sustainable long term growth and shareholder.
Overtime.
George married and Bob a couple of details of our first quarter performance in a few moments in the meantime, I would provide an update on our goal of continuing to grow up business, while simultaneously diversifying our revenue and earnings streams, which is part of our long term vision for regeneron.
We have made substantial progress toward achieving that go over the past four years, while total revenues have nearly doubled I Lee accounted for only 57% of total revenues in the first quarter of 2023 compared to 88% of total revenues for the year 2019.
Driven primarily by the growth of Dupixent, our sanity collaboration accounted for 25 per cent about total revenues in the first quarter of 2023 compared to only 6% of our total revenues and 2019.
We expect this trend revenue growth along with diversification to continue.
For example, assuming the approval and successful launch of a of a flipper said eight milligrams, which has a June 27th produce a day I lead two milligrams is expected to become a smaller share of our revenues while a flipper said eight milligrams is expected to contribute to overall revenue growth.
In addition in addition, Dupixent remains in a high growth mode with global net product sales at 40% on a constant currency basis compared to the prior year quarter driven by growth across all five approved indications. We believe the positive phase three results for Dupixent cause there's some.
Population of COPD patients with evidence of type two inflammation.
As well as the promising results for our I owe thirty-three antibody.
<unk> and former smokers.
Represent additional significant opportunities to accelerate revenue growth as well as diversification.
Alright oncology profile portfolio is also starting to make a meaningful contribution to our top line with lashes acquisition of full global rights to Libtayo and the recent launch of Libtayo in combination with chemotherapy and advanced non small cell lung cancer.
Moreover, we believe that Seattle that are lagged three antibiotics in combination with Libtayo has the potential to become an important therapy involved melanoma and not in small cell lung cancer, where we have already advanced two pivotal studies.
We are also quite excited about the emerging clinical profile for Limbaugh <unk> R. B C. M. A C D three five specific.
The data for which will be presented at the upcoming <unk> annual meeting we remain on track to submit a b L. A C. K accelerated approval in late stage myeloma later this year.
We continued to invest in a research and development engine unexpected will deliver new differentiated medicines that will drive organic growth over time.
Road development pipeline of nearly three dozen programs spans many different therapeutic areas and modalities, notably co stimulatory buys specifics and cancer.
Pipeline and cardiovascular metabolic diseases as well as a collaboration without an island and <unk> and others are expected to drive medium and long-term revenue growth profitability and diversification.
Before handing over to George I'd like to take a moment to recognize the contributions that's after Roy VAG lows is made to a general over the nearly three decades that he has served as a board chair.
Over the years. He has provided invaluable guidance and he continues to inspire S. As we work to turn World class science into medicines.
Reliable retired from the board. After his current term ends next month at that time. In addition to our current roles of the company, Georgia and I will be appointed by the board to serve as co chairs and Christine <unk> a member of Regeneron sports since 20 cents will be appointed as the boards lead independent director with that.
Let me turn the call over to George.
Thank you and the first quarter of 2023 delivered multiple significant milestones for regeneron and for collaborate collaborations from the positive to pick some phase III C. O P. D data to progress in oncology pipeline as well as exciting new landmarks from our genetic medicines programs sorry.
Sorry, you have to fix it.
March together with our sanity collaborators.
56, it was the first new mechanism of action treatment to produce statistically significant and clinically meaningful results in a phase three trial for C. O P. D. In over a decade Arboreous trial enrolled COPD patients with moderate to severe disease and evidence of typed your information.
<unk> treated patients demonstrated clinically meaningful 30 per cent reduction in exacerbations, a significant improvement in lung function as well as quality of life benefits and impressive try sector and a potential paradigm changing treatment for this deadly disease.
We are looking forward to presenting the detailed boorish result in a late breaking presentation at the upcoming.
American Thoracic Society meeting later this month.
We also plan to discuss these exciting results with regulatory authorities. They expect to report results mid next year for the replicate save three noticed study.
I would remind you that we're also trying to address and overlapping COPD population with our I R 33, <unk>, which is in phase three studies based on positive phase two proof of concept data.
This approach is further supported by genetic analyses from Ah Regeneron genetic center, which demonstrated association of loss of function interleukin 33 with reduced COPD risk similar genetic analysis supported the rope for a dupixent benefit in C. O P D.
The boy is C O P. D data indicate the dupixent can help even more patients beyond the five current F. D. A approved indications and diseases caused or exacerbated by type two inflammation, including atopic dermatitis asthma chronic one side of fries with nasal polyps you seem to feel like <unk> and <unk>.
We're also expecting F D. A decision for <unk> for chronic spontaneous or to carry out in October 22nd 2023.
Continuing to tailor depicting development to patients with other types of inflammatory diseases, most likely to be responsive to this medicine.
Moving to oncology with the progress of our late and early stage pipeline. We're looking forward to several important milestones this year, starting with with tile. In addition to expand it using lung cancer.
Was recently added to the N T C and guidelines for new as in treatment of CFCC.
<unk> U S label was also recently updated with more mature C. SEC N B C. C data supporting it's differentiated clinical profiling these tumors settings, and satisfy all postmark and commitment required full approval and these indications.
Regarding our exciting new combinations with what's out there <unk>, our lack three antibiotics for which we are planning a broad pivotal program spanning several cancer indications. These efforts were triggered by a robust and confirm data and first line metastatic melanoma patients, which will be presented in further detail at ascot, suggesting that the <unk>.
<unk> combination could produce about double the response rates with longer progression free survival.
Thai Piedmont in therapy standard.
Based on this we have already initiated a pivotal trials and metastatic an accurate melanoma noodle started studying perioperative melanoma in the second half of the year.
In addition, based on promising data and swore patient cohorts. We started seamless phase two three pivotal study for treatment of metastatic non small cell lung cancer, and we will Sue started phase two study and the perioperative setting.
Next to buy specifics for solid tumors, which are being investigated in combination with with time.
Early this year <unk> G. U we presented initial positive first and human data for P. SMA by city 28 coast inventory by specific in combination with reptile in advanced prostate cancer or tumor type considered email actually cold and largely unresponsive to anti P. D. One therapy alone over the next 12 months, we plan to present.
Updated P. SMA by city 28 data any more patients some of which will have been prophylactic, we treated with our anti Iowa six receptive antibody. So really mean to pretend to reduce the severity of the <unk> side effects, while maintaining or improving antitumor activity also during this time frame we plan to present data in advanced ovarian cancer for both of them.
<unk> Bye C D. Three by specific <unk> by city 28, co stimulatory by specific as well as data in several tumor types from our Egfr by city 28 conciliatory Bispecific.
In combination with wood tile.
Ah Hematology oncology pipeline continues to advance in an oral presentation. The upcoming ask a annual meeting we will present updated data for <unk> R. B C made by C. Three bispecific tested in late line multiple myeloma. We believe these data will show the <unk> Linda Self-command has the best in class potential with differentiate it.
Efficacy safety and a favorable dosing schedule in the competitive environment of relapse refractory multiple myeloma treatment, Kansas remain on track for regulatory submission in the United States in the second half of this year <unk> furniture next to map our city 20 by two three by specific we are on track to complete you as an E regulatory submit.
<unk> for both relapse refractory Follicular lymphoma, and diffuse large <unk> in the second half of this year or genetically map in late line relapse refractory Folliculin apartment has a potential best in class efficacy profile.
Optimize step up dosing regimen has improved Oh, janette, there and safety profile without impacting efficacy.
Also we have initiated your first and human study of our C. D 22 by 328 coast inventory by specific in combination with Audra next to Matt and relapse refractory D. L. D C L, which we hope could further improve upon the anti cancer benefit for these patients.
May I ask that genetics medicines started with our collaboration with online NASA Irna Therapeutics, just last week we.
Announced an import update for a <unk> a P. P program in early onset Alzheimer's disease for the first time in N and RNA I therapeutic demonstrate sustained silencing of a pathological gene in the central nervous system in a clinical trial.
In their earnings called this morning around the island collaborators provided additional details on these results are S. Irna approach aims to prevent production of amyloid precursor protein as opposed to clearing existing amyloid plaques. After they have already formed providing a new way to potentially address Alzheimer's disease, which will still.
Have a devastating impact on patients and their families even with the emergence of amyloid clearing antibiotics.
Patients treated with single doses and a P. P experienced dose dependent rapid and sustained reduction of up to 90 per cent and a P. P production.
<unk> bye bye markers in cerebral spinal fluid the safety in Calbury profile with symbols dosing is encouraging so far well the multi dose puppy portion of the studies on partial clinical holding the United States do to finding reserved and Pryor Nonclinical chronic toxicology studies puppy has already received regulatory approval to proceed in Canada, where.
The majority of the part of a clinical trial patients had been enrolled detailed results from this study will be presented an upcoming medical me. We're looking forward to advancing additional development candidates for the many other neurodegenerative diseases that currently have few or no therapeutic options.
Such as other targets for Alzheimer's as well as for L S or Lou Gehrig's disease Parkinson's in Huntington.
In addition to these exciting developments in the central nervous system diseases. We are continuing our progress will liver targeted medicines, including a broad and multi pronged approach to develop treatments for Nash or none alcoholics detail hepatitis, where enrolling a phase two study of ale N H S D and Nash patients with genetic risk factors continue.
Development of Ale M. P N T and we're planning to progress additional more recently genetically validated Nash targets as well.
Finally, I would like to highlight a recently announced collaboration with Sonoma Biotherapeutics discovered develop and commercialized regulatory T cell therapies for auto immune and inflammatory diseases.
[noise] collaboration will bring together or industry, leading technology is for the discovery characterization of fully human antibodies and T cell receptors as well as our additional biologics candidates with Saddam is pioneering approach to developing and manufacturing G modified T Ragsdale therapies.
Conclusion, Regeneron R&D engine truly continues as productivity and both late and early stage pipeline.
Before turning the call over to me and I would also like to thank Roy Patulous for serving as a role model for all of us as regeneron as well as for so many others across the industry I hope that we can continue to live up to the high standards that Roy headset over his distinguished career.
With that I will turn the call over to Marin.
Thank you George our first quarter performance demonstrate ongoing leadership across multiple therapeutic categories taken together are in market brands.
David near term launching an extensive development pipeline unique reposition regeneron to expand our leadership across multiple cause these areas.
First quarter I Leah U S. Net product sales declined six per cent <unk> 1.43 billion.
In a sequential quarter basis.
<unk> net product sales decreased 4%, reflecting the favorable impact of higher demand volume offset by Lois sequential wholesaler inventory levels higher sales related deductions and increasing competitive pressure.
Leah captured approximately 70 per cent branded sharing the first corner.
Based on presentations at scientific meetings. The retina community has expressed increasing enthusiasm that retain round portfolio with your slippers had eight milligram to dissipate now seven weeks away I Leah is the well established gold standard antiviral treatment and if flippers of eight milligrams has the potential to be as parrot.
I'm changing as I Leah when it was introduced more than a decade ago and clinical trials the slippers to the email Graham demonstrated improvements in visual acuity with less frequent injections and the safety profile comparable <unk> exactly what retina specialist have told us they need in the next generation medicine.
Preparations are well underway and we look forward to bringing this important treatment option to patients following at T. In your profile.
<unk>, which is foundational to reach enron's oncology portfolio first quarter global net product sales, Chris 49% on a constant currency basis, reaching $183 million, which included 6 million from sanity transition sales and international markets and the U S <unk>, 39% <unk>.
Third and $10 million.
<unk> continues to lead the market and burst advanced CFCC, an advanced P. C C. As demand volume increases following last november's F. D. A prisoner tile in combination with chemotherapy for first time advanced non small cell lung cancer, new patient start to the accelerated.
Physicians and <unk> is an important need treatment option initiatives to raise brand awareness and improve access of German share gains in both the academic and community settings.
<unk> net sales grew 67 per cent on a constant currency basis to 73 million driven by steadily increasing demand any additional country launches European Commission recently approved tile in combination with chemotherapy for P. B L. One positive lung cancer and we are in the process of securing access and reimburse.
<unk> for this new indication.
Turning to the pics and first quarter global net sales cause 40 per cent on a constant currency basis to 2.49 billion in the U S. Net sounds good 43% to 1.9 billion with notable volume glad to crush all approved indications driven by a text outstanding efficacy and safety profile depiction is the number one prescribed.
Dialogic for new patients in all five of its appraised indications.
Any type of dermatitis depiction as the leading to stomach treatment based on that unique mechanism of action clinical profile <unk> world experience strong prescribing trends continue request moderate and severe disease and across approved age ranges. There's also a significant opportunity to further increase market penetration as it takes me a uniquely dizzy.
And to provide an effective safe inconvenient treatment for peace patient six months and all that and.
<unk> only F D. A approved stomach treatment lunch uptake is progressing well and we anticipate <unk> as we leverage our dermatology commercialization capabilities for patients who need.
Across the competitive asthma space depiction continues to gain market share is naive and biologics switch patients are initiated on treatment depicts it also continues to capture the majority of market demand and need some pilots with increased prescribing from allergist and Nancy's alright.
Alright, <unk> salpingitis lunch is exceeding expectations and the first year. Following you. This approval more than 11000 patience is initiated therapy, demonstrating extensive unmedicated need and are strong launch execution in collaboration with Santa Fe.
Gastroenterologist, an allergist has embraced depiction as the new standard of care setting meaningful improvement in disease symptoms and quality of life for that but there is now on therapy any patient campaign is underway to raise awareness of the scientific advancements in treating you send it sound like esophagitis.
At <unk> net sales were 587 million caller, 30% on a constant currency basis shares of that growth across approved indications and launches a new geographies recent European improving <unk> esophagitis, <unk> and atopic dermatitis and young children are expected to contribute to the <unk>.
And growth in summary, or commercial portfolio continues diversify across many serious medical conditions and delivered solid results in the quarter moving forward, we are well positioned to serve even more patient driven by the strength of our existing portfolio, coupled with anticipated lunches that have the potential to advance.
Standards of care with that I'll turn the call to <unk>.
Thank you Marianne my comments today, I'm Regeneron financial results and outlook will be on a non-GAAP basis, unless otherwise noted.
Regeneron performs well in the first quarter of 2023 with solid financial results first quarter total revenues increased 7% year over year to 3.2 billion as Dupixent <unk> contribute to increasingly diversified revenue and Ernie streams.
First quarter diluted net income per share was $10.09 on net income of 1.2 billion, which included a previously announced 42 cents impact of acquired high P. R and D.
Beginning with collaboration revenue in starting with bear.
First quarter 2023, <unk> in that product sales were $847 million.
4% on a constant currency basis versus the first quarter of 2022 total bigger collaboration revenue was 357 million of which 332 million related to our share of Eylea net profits outside the U S.
Total sign up fee collaboration revenue was 798 million in the first quarter in grew 26% versus last year's first quarter, which included a 50 million dollar sales milestone <unk> that did not <unk> this year.
Our share of profits from the commercialization of the pixel incomes are was $637 million an increase of 53 per cent versus the prior year, we continue to see increasing profitability from our antibody collaboration and expect further margin expansion as we begin to realize drug substance yield improvements from a new regeneron develop.
The manufacturing process for depictions.
Finally, we recorded Roche collaboration revenue of 222 million in the first quarter for our share of gross profits from X U S sales were <unk> related to a previously signed contract we do not expect to record any additional revenue from grownup breathe in 20 twenty-three absent a new contract.
Moving now to operating expenses first quarter 2000, twenty-three R&D expense increased 28% year over year to $960 million as we continue to invest in our pipeline to drive organic growth. The increase in R&D was primarily driven by higher headcount and related costs and funding of the company's growing pipeline, which.
Now encompasses approximately 35 programs in clinical development.
And more than 15 ongoing late stage studies with additional study starts expected. This year. These late states programs include are expanding <unk> development program upcoming phase three studies in earlier lines for <unk> as.
As well as ongoing development programs for depiction and into Peck them App for which we know record our 450 per cent share of development costs as a result of the lip taio transaction.
SG&A expense increased 32% year over year to $515 million due to higher contributions to an independent not for profit patient assistance organization higher headcount and related costs in the impact of the lip taio transactions.
First quarter of 2023 C. O C. M was 249 million up 26% versus last year.
Due to increases in shipments of X U S commercial supplies of <unk> and manufacturing costs for depiction reimbursements for these production costs are recorded as part of other revenue insanity collaboration revenue respectfully.
Shifting now to cash flow and the balance sheet and the first quarter of 2023, Regeneron generated 1.2 billion in free cash flow. We ended the first quarter with cash and marketable securities less debt of $12.3 billion. We have continued to just two strategically deploy our cash to deliver on our capital allocation priorities, which are folk.
Start investing in innovation, both internal and external as well as returning capital to shareholders.
We are updating 20 twenty-three C O C M guidance to be in the range of 820 $880 million, an increase of 90 million at the midpoint, reflecting increased shipments of X U S commercial supplies for <unk> to Santa fee. Importantly, these are anticipated incremental expenses will be reimbursed.
As a result, we now expect 2023 other revenue to be higher than 2022 other revenue for modeling purposes second quarter 2023. Other other revenue is expected to be the lowest of the 2023 quarters with the vast majority of the remaining other revenue to be recorded in the second half of this year.
The change in expected gross margin is primarily driven by an unfavorable changing product mix as well as an increase in the startup costs associated with our new filled finished facility located in upstate New York.
Finally, we are lowering her guidance for effective tax rate, the 10% to 12%, reflecting the benefit of higher than previously anticipated stock based compensation deductions and conclusion Regeneron continued to deliver robust financial results in the first quarter of 2023, and the company remains well positioned to drive further growth and the remainder.
Of the year and beyond with that I will now pass the call back to Ryan.
Thank you Bob Josh that concludes our prepared remarks, sweet now like tell from the cough or Q&A.
Our first question comes from my friends.
You May proceed.
Sure they happy to come in and you know as I noted as they're reporting on the quarter performance honest sequential basis, we did see with Andy <unk> sequential quarterly basis. So we did see with <unk> and net product sales just curious of 4% as I mentioned it is driven by a number of factors Sir.
Digest category now something that we would never necessarily identify with a particular product.
More of the totality of competition I will come in said in the quarter. We certainly maintained a 70 per cent branded chair and over at approximately believers of 46% share in the <unk> category, So certainly standard tier with Eylea and there.
Importantly, we look forward to launching a sliver seven eight milligram as I mentioned now is about seven weeks away.
Thank you.
You May proceed.
Alright, Thanks for taking my question. So just some questions unlocked three and I'm thinking about the first line melanoma market since you're going to be having data relatively soon so what I guess there's.
Mmm Multipart question what is the bar for success, you think for the combination to be competitive.
And when you think about penetrating in <unk> in in checkpoint monotherapy pockets for first line now I know that can you help us understand how big these buckets are so I can actually model this opportunity better. Thanks.
Well as we've already reported based on our to confirm a story cohorts. We are seeing remarkable overall response rate increases over the P. D. One standard alone almost doubling with much longer PFS, if we get anywhere near.
Anywhere near the numbers.
A war with a satisfactory safety profile, which.
We had seen a favorable safety profile in the small studies, but if we reproduce or come anywhere close to reproducing these results.
We believe that this will establish an entirely new standard of care for this disease and as we all know the first line melanoma opportunity is very large, but we're also moving you know.
Laterally in earlier and so forth into many additional applications within the melanoma.
Opportunity itself will go already know an adjuvant.
Entering neo adjuvant studies will also be going to other kansas settings, including lung cancer and so forth. So we consider this a major opportunity and we can we can only hope to if we approach the data that we've already seen you know earlier studies. It really has a chance to make a huge difference for.
These patients.
Thank you.
Our next question comes from Tyler.
T D. Kyle and you May proceed.
Hey, there are good morning. Thank you for the question for high dose.
So on the regulatory up there we don't comment on ongoing.
Stuff I'd like to say what are you looking forward hopefully to reaction of the F. D. A on June 27th and a lunch break there after Mary and you can comment on the inventory sure Tyler I can give you the detail there so well still within the normal range of the inventory related to your question an idea in the court.
You're in the normal range is five to 10 days.
Alright inventory levels, where approximately three days lower at the end of the first quarter of 2023 compared to the end of the fourth quarter of 2022, and you know what.
When you do the calculation on that as I'm sure you all will deal that's a negative impact in the first quarter net sales of approximately $70 million.
Thanks, Thanks, Marian Tyler moving to the next question please Josh.
Thank you.
Our next question comes from parents.
Oregon Stanley He May proceed.
<unk>. Thank you so much.
Sure I'm very happy to come in and you know as we think of just makes sense and all the different therapeutic disease areas. A specialist that we cover you know there's some indications there certainly is an amazing and wonderful synergy and you give an example, with C O P D launch potentially and obviously today.
They were in market with our asthma indication name with nasal polyps.
Look for that C. O P. D. It's a really important launch any indication to help patients in a way potentially that you know is George described hasn't been achieved ever for for this population. So we have the opportunity to use our existing footprint specifically in <unk>, you know covering respiratory specialists pulmonologist <unk>.
C O P D.
It is interesting just add a little bit to that Marian that's the allergies seem to have really understood.
Concept of type two information and the fact that types of information is not a collection of individual unrelated diseases as a collection of related diseases and I was speaking to an allergist survey says that when you take an asthma patient and if you look carefully many of them will have a nasal polyps and if you talk to Jeremy.
<unk>, the beginning to understand that when they're treating a taboo dermatitis people have whoever contaminant asthma for example, they get a benefit there. So I'd hate to fix them really is kind of unique and we are talking to the main doctors, including the allergist a dermatologist in the Pulmonologist uhm.
With regards to your your question on leverage first off will come back to us to have you back on the team.
And again, that's half the economics on the.
On the transaction. So we're we're we're beginning to.
Does she really great leveraged into marion's comment that should continue on with the C. O P D indication.
Obviously, we work very closely with fantasy on all of these and and I believe it's fair to say equally excited about the potential for the future of Dupixent and all the current and hopefully future indications.
Thanks, everyone.
Thank you.
Our next question comes from Christopher Raymond with Piper Sandler You May proceed.
Thanks, Yeah, maybe another depiction question if you don't mind when I know you don't talk about regulatory interactions but.
You know when you had the C O P D data I think the.
The signal that I got.
Just kind of maybe you can map out how you anticipate communicating you know the results of that discussion with F. D. A once that happens.
Central counts as low as 202 50, just maybe your thoughts on this and how Ya I anticipate to sort of.
<unk>, obviously what were all staring at is an incredibly positive study.
His III setting.
Whereas we've mentioned that we not only improve people's.
Exacerbations, but we also improve their lung function, okay lung function in our quality of life and all this other measures they're all part of the statistical hierarchy. So when you have a very robust study like that and you have.
Thank you.
And we are actively involved in all aspects of lunch preparation and you know certainly that you know include all elements and levers associated with pre market activities and then getting ready for the launch activities. We do have in place very soon.
Our next question comes from Chris shot with J P. Morgan you May proceed.
Medical Anonymised medical information, we use that in so many ways not only to identify targets, but to validate the work we're doing in specific targets specific diseases.
How much have we gotten we've seen is that half of all humans who've been sequence. So that's a large database of.
Millions and I think that that is what you're hearing is that that's why we had more confidence perhaps than others do.
And we're now with anti I have 33, alright since since then expand that just a little bit just to let you know how it works. What we do is we identify genetic variations that mimicked the blocking of a drug or exacerbation of this type two pathway and what we showed for dupixent.
For the genetic variations that mimic dupixent those people were protected from COPD, particularly the type to C. O P D patients whereas.
Increased activity of the Ah 413, pepper was associated with more disease, and obviously that turned out to be the case I mean human genetics is a very very powerful breaker and we've done the same thing as Lin said with the aisle 33, where we have genetic variation that mimics blocking the pathway or exacerbating the path.
And as I said this is one of the secrets to.
To our ability to to have high success rates in our studies is we use that as a criteria to make our decisions going forward.
Okay. Thank you next question please Josh.
Thank you.
Our next question comes from your attention.
Security. So you May proceed.
Yeah, Hi, this is <unk> and thanks for taking my question. This morning I was wondering if you could talk about the draft guidance from the F. D. A on the anti Badger trial designs and if that impacts your outlook on high dose program at all thank you.
I don't think that has any impact on us and.
Program.
Thank you next question please.
Thank you.
Our next question comes from David rising or with a C. V Securities can you May proceed.
Yes, thanks very much.
And I guess I'll just go straight to the question. When you had mentioned in your opening remarks beyond going diversification of the company's revenues away from Eylea could you. Please discuss your expectations for <unk>.
<unk> R U S sales growth in the near term, including the total Eylea franchise prospects after regeneron launches B H D. Thank you.
Let me go right to the the answers since you were right to the questions, we don't give a future guidance.
Specific quantitative measures of ourselves on a qualitative faces Marion has said that we're anticipating that the combination of <unk> and eight milligrams flipper set will be a growth franchise.
Time for the company Okay.
Okay. Thank you next question please.
Thank you.
Our next question comes from our tellers.
You May proceed.
Great. Thank you and just a quick question.
The map.
Ash presented one data.
Oh really interesting data.
Oh and ask what should we expect to see what would be dose expansion data.
And then any duration also on the patient.
Ash and then what would F D. A like to see you know before we can go ahead and submit the application.
Well I think you're going to actually see an update on our cable phase two data the actual day at that with a little bit more mature right with a further update we will be hoping to submit to the to the F. D. A for our BLA. So.
No that will be very close we thank you Katie will even get better as it matures cause as we all know response rates and so forth get better with time as you follow these patients, but do you feel that are gonna show. What we believe are the potential to have best in class.
Efficacy as well as safety in a favorable dosing schedule based on the results that will show up from our pivotal study at the upcoming ask though.
Alright. Thank you George I think we have time for two more questions.
Thank you.
Our next question comes from Carnival.
Barclays you might proceed.
Good morning, Thanks for taking my question I'm sorry.
I guess, just simply want the pricing pressure that you guys highlighted in queue.
[noise] dynamic or would you characterize it that or something more permanent around that market landscape going for it. Thank you.
For my own answers that we just wanted to come back to the D. C. M. A sorry little bit cause it's one that I'm, particularly excited about the by specific field, which was initiated thyroid janitor on it in terms of using five specifics I think we were the first to.
To put the Bible specific interpretation is obviously become a very crowded space and it's sometimes hard to differentiate what you've got compared to what the competition.
And you look at somebody claiming one thing and then you're claiming another and so on and so forth, but if you take a dispassionate view I think for the D. C. M. A C. D. Three program you can really see a differentiated in a molecule and a potential to be best in class antibodies are not all created equal five specific.
So that all created equally you do see differences clinical trial programs now okay. Legally. This is one I really encourage you to take a very careful look at and compare.
Yeah. There was some question I may get married and you're Gonna answer sure and Carter getting back to your question on the competitive dynamic in pricing pressure you know I think if you look at the antique digest category and look at it over time go back multiple orders there has been increasing competitive pressure and that dies then have.
A corollary to some extent on pricing dynamic and that would go for it but I I just want Elon Sharon remind all of that in the category. Indeed that yet individuals category, what really has rewarded its product profile and and at least we look at a product like I Leah It launched in was a game Chi.
Change your in the category that was its profile not being the least costly right. There's been a low cost alternative very low cost alternatives for a very very long time, but it was the product profile that made the difference for prescribers impatient. So that will always be a very dynamic to look at going forward and certainly has in a strong interest.
Asked for prescribers as we bring a new product into the marketplace. Following at the approval <unk> with a <unk> flavor steps eight milligram, but to your point pricing pressure will continue in this category, but what's most important is product profile and the clinical attribute that the patient experiences.
Thanks last question please.
Thank you.
Our last question comes from I haven't seen him in was BMO you May proceed.
I got it. Thank you for squeezing me and I'd Love to have you expand on some of the feedback you've been hearing from physicians regarding the eight milligram dose maybe some color as to how they plan on using it assuming approval come June thank you.
So of course, the the updates on actual prescribing will.
Even more important as the product comes into the marketplace and physicians have an opportunity to use it and select patients. We obviously has done a lot of work with our medical team looked at the clinical data with specialists and to give you an early answered. Your question I think there's an opportunity for a variety.
If patients that are deemed to be appropriate candidates and and there's a range certainly many physicians are considering new patients starts it's very attractive we obviously have a.
Strong portion of patients that are naive <unk> today, but in the future. The question becomes why wouldn't you starting new patient with the product. It gives you all the visual acuity benefits and safety <unk>, but it also gives you that your ability and duration because you know obviously physicians narrative patients are anxious and you know don't like to have more.
<unk> and the I that they need to similarly, you might have a patient it's theory well controlled another product maybe <unk>, maybe another product and the internet just category, but you'd like to give them that opportunity for duration and maybe in some cases, if the product is and you know another area of the anti that just category improved visuals.
Witty and duration, so I would say, it's the combination of interest for patients who might be broadly <unk> category switch patients or the potential for new patients as well I I hope that helps and look forward to the day. When we can give you specifics for market experience.
Mmm, Thank you Marion and thanks to everybody, who dialed in and for your interest in Regeneron, we apologize to those remaining in the queue that we did not have a chance to get to.
As always the I R team is available to answer any remaining questions that anyone may have thank you once again and have a great day everyone.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
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