Q3 2022 Regeneron Pharmaceuticals Inc Earnings Call

November 3, 2022

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

Yeah.

Okay.

Hello, and welcome to Regeneron Pharmaceuticals third quarter 2022 earnings Conference call My.

My name is to Wanda and I will 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 to ask a question. During the session you will need to press star one on your telephone.

Please note that this conference is being recorded.

I would now like to turn the call over to Ryan Crowe, Vice President Investor Relations you may begin.

Archive of this webcast will be available on our Investor Relations website. Shortly after the call ends.

Joining me today are Dr. Leonard Schleifer, founder President and Chief Executive Officer, Dr. George John Coppola, Co founder President and Chief Scientific Officer, Marion Mccourt Executive Vice President and head of commercial and Bob Landry Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

Forecast and guidance development programs and related anticipated milestones collaborations finances regulatory matters payer coverage and reimbursement issues intellectual property pending litigation and other proceedings and competition.

Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement and.

A more complete description of these and other material risks can be found in regeneron <unk> filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended September 32022, which was filed with the SEC. 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 that GAAP and non-GAAP measures will be discussed in today's call information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be assessed accessed on our website.

Once our call concludes Bob Landry and the IR team will be available to answer further questions.

With that let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer.

Thank you Ryan and thank you to everyone joining today's call Regeneron.

We generally strong operational momentum continued in the third quarter highlighted by important developments across our pipeline and outstanding commercial execution.

Total revenues for the quarter increased by 11% compared to last year, when excluding contributions from our Covid antibody cocktail with global net sales of the pixel and Tayo as well as U S. Net sales of Eylea once again, reaching new all time quarterly highs and growing by double digits.

Before diving deeper into our commercial results I'd like to review some of the recent progress we have made across our pipeline.

Starting with the striking pivotal data that we reported in September for our investigational <unk> eight milligrams, which we believe could ultimately transform the treatment landscape for patients.

With nearly 90% of <unk> patients and 80% of wet AMD patients able to sustained 16 week maintenance dosing through 48 weeks of treatment.

We believe a flipper set eight milligrams may shift the current treatment paradigm with more patients receiving less frequent injections, while achieving visual acuity gains anatomical improvements and a safety profile comparable to eylea.

It has proven to be very difficult to decrease the treatment burden beyond what we were able to achieve with eylea over a decade ago with many potential treatments failing either due to sub optimal visual outcomes or safety issues.

Recently approved anti VEGF agents did not demonstrate in pivotal studies that the majority of patients in either disease, we're able to sustain 16 week maintenance dosing throughout the first year of treatment supporting our view that a flip it's at eight milligrams has the potential to become the next generation standard of care and.

I bet, you have treatment assuming regulatory approval.

We plan to submit the flip is at eight milligram pivotal data to the FDA under a single BLA at the end of this year and have decided to use a previously granted priority review voucher to expedite the FDA review process.

Relaunched planning is already underway with a potential FDA approval by late August 2023.

In addition to the pivotal of slippers had eight milligram data regenerative continued to make notable progress.

200000, more patients with these type too inflammatory diseases could benefit from Dupixent unmatched clinical profile.

Additionally, we expect pivotal beta read apps for depiction and chronic inducible cold Arctic area and quite a chronic obstructive pulmonary disease in the first half of next year.

Moving to oncology, where the depth and breadth of a pipeline has position to be generous to ultimate ultimately become a global leader.

We presented several data sets at this year's European Society for medical oncology annual meeting further underscoring the importance of Libtayo as the foundation for our overall oncology strategy.

George will review the data in more detail during his remarks, but we were particularly encouraged by the results for Libtayo mono therapy, and neo adjuvant CFCC as well as the time in combination with C N lemass.

Our lab three antibody and first line metastatic melanoma.

We also presented monotherapy data for a.

16 by C. B, three bispecific and recurring ovarian cancer, which has the potential to be combined with the tile as well as data for are met by met bypass topic by specific and met altered non small cell lung cancer.

I'd also note.

Early but very exciting results for a P. S. M. A buy C. D 28, co stimulatory by specific in combination with Libtayo, which you're promising anti tumor activity in patients with advanced metastatic castrates musician resistance.

Cancer.

The patients enrolled in a study.

A poor prognosis with an expected survival of one to two years, depending upon their treatment history.

Given prostate cancer has been largely unresponsive to P. D. One inhibition and immunotherapy in general there is a clear need for new treatments and Twenty-twenty alone.

375000 deaths globally from prostate cancer and it was the second leading cause of cancer death in American men.

We continued to expand costumed misheard by specific efforts and prostate cancer with an acceleration in enrollment in a person you can study since we reported our top line results in August and we look forward to update you on this program in the first half of next year.

Now turn into a commercial performance in the third quarter Elliot Global net sales grew 8% at constant currency to $2.4 billion in the U S. Alien net sales were $1.63 billion up 11% year over year.

Performing the anti veg of category growth of only 4%.

Spike recent branded and Biosimilar entrance I list that a new all time high for anti VEGF category sure in the United States.

Typically continued to grow at a remarkable pace posted by approvals and new diseases and younger patient populations in previously approved locations.

And the third quarter Global net product sales were 2.3 billion up 45 per cent at constant currency compared to last year, reflecting growth across all indications and all geographies.

Pictures differentiated clinical profile.

Billy Furtively treat more and more patients.

Both currently approved indications and potentially for additional type too inflammatory diseases is expected to drive strong growth in the future.

Reptile total net sales group twenty-five percent globally at constant currency to $143 million in the third quarter, including 21% growth in the United States driven by non melanoma skin cancer indications and mono therapy, non small cell lung cancer at the <unk>.

Out of the third quarter, we acquired global rights to live tie up from Santa Fe.

Potential future combinations, including with chemotherapy and non small cell lung cancer as well as other pipeline agents and development. We believe libtayo is poised to become a more meaningful revenue contributor overtime.

We are excited about the strong commercial performance for our core products, the compelling efficacy safety and durability data that we reported flip it's at eight milligrams as well as the notable progress we have made advancing our pipeline, particularly in oncology pipeline.

Pipeline now includes approximately 35 private candidates and clinical development, including a number of marketed products that we're investigating traditional indications some of which George will discuss in a moment.

Closing our strategy continues to focus on investing in our internal R&D capabilities, while exploring potential collaborations that will enable us to fully realize the power of our science.

We remained confident in this strategy and and a good prospects as well as in our ability to deliver breakthroughs to patients and value to shareholders now I'll turn the call over to George.

Thank you Lynn.

I'll start with ophthalmology.

Positive pivotal results for flavors of eight milligram and the pulse or in Fulton Studies recently presented the American Academy about the miles of annual meeting.

Results of these trials and wet AMD Indian the respectively demonstrated that a remarkably high percentage of patients.

We were able to be rapidly initiated into and then successfully maintained through week 48, and 12 and 16 week dosing multiples.

<unk> vision games that were not inferior to the current standard of care Lia two milligram just every eight weeks.

These results suggest that <unk> eight milligrams has the potential to become the new standard of care in these retinue diseases.

I think it would be helpful. If we step back for a minute and try to put these results in context.

Trial, what our trials did was push the limits far beyond what has been accomplished with any currently available anti VEGF therapies.

Rather than using response criteria to try to identify where slowly extend patients to longer dosing into those are trials tested whether all patients could be randomly assigned and rapidly initiated an extended dosing intervals flipper steps eight milligram without compromising visual improvement.

Safety these.

These are flavors of eight milligram trust accomplished just that for the vast majority while delivering a safety profile consistent with data by Leah.

89% of patients and 77% of wedding M. D patients were able to be rapidly initiated and maintained and a 16 week <unk> eight milligram dosing regimen, while 93 per cent of D me and 83% of wedding M. D patients were able to be rapidly initiated maintained and at least a 12 week.

Dosing interval.

While delivering advocacy similar to that about it via administered every eight weeks.

We believe these are truly unprecedented and potentially game changing results, which have not been achieved using any other anti VEGF agent.

Oh. This is speculated that are pulsating photon results were due to our dose modification criteria.

Even tried to theoretically extrapolate.

Your agent could have somehow approached these results using our criteria.

We put these speculative extrapolation into the category of wishful thinking and.

And based on our expert analysis of the data we conclude it is all about the drug and not the trial design.

Briefly moving onto Dupixent building in a recent approval and eosinophilic esophagitis in adults and adolescents. We are planning on submitting a supplementary BLA for eosinophilic esophagitis and went to 11 year old children in mid two twin twenty-three to fixing the ability to treat eosinophilic esophagitis highlights.

How important it is that R. I O L 13 block or more completely targets the entire type too inflammatory cascade and not only is cynical.

As you heard land mentioned the F. D. A label was expanded yet again in the third quarter. It depicts and became the first and only treatment indicated for Prurigo, Nigel Arris debilitating chronic skin disease.

This marks the fifth disease for which Dupixent has now approved a collective clinical data with the pics and support a unifying molecular mechanism underlying these related diseases from asthma <unk> topic dermatitis to nasal polyps two <unk> two <unk> two <unk>.

And its unifying subconscious I'll for an iPhone 13 induce inflammation is driving all of these related diseases and different tissue compartments.

Moving to Libtayo in oncology in the third quarter, a robust oncology pipeline has started to deliver data readouts from our latest and most innovative programs and we're expecting these readouts to accelerate in the remainder of 2022 and the continuing to 2023.

The European Society of medical oncology or Eskimo annual meeting September was truly a banner event for regeneron with several notable oral presentations for acid sooner oncology pipeline, which I'd like to briefly summarize.

Starting with the elements are lecturing anybody in combination with with child, an Eskimo we shared data from two independent advanced melanoma expansion cohorts from my first Inhumans study, which importantly showed consistent efficacy and safety between the two replicate cohorts the element in combination with.

Titled demonstrated greater than 60% response rates and each cohort a medium PFS estimated to be 24 months across both cohorts and a median duration of response that had not yet been reached the preliminary safety profile at the combination appears to be in line with the anti P. D, one monotherapy and potentially with less toxicity.

Compared to anti C T L a for combinations.

Well <unk> inhibition has previously shown promise an advanced melanoma response rates greater than 45% with medium PFS of more than a year had not been previously reported. These initial results of melanoma suggests that the annual Nablus tile combination is a P.

Potentially best in class profile in this setting where enrolling our phase III metastatic melanoma studying intend to initiate a phase III adjuvant Melanomas study later this year and have additional plans and other solid tumors were for element has the potential would be first in class.

Neo adjuvant cutaneous squamous cell carcinoma or CFCC.

To study of Libtayo monotherapy shown promising results.

Given prior to potentially cure this surgery and patients with large tumors with Ty was able to deliver major pathological responses to 63 per cent of patients prior to surgery.

This raises the possibility that libtayo could decrease the burden of these major and potentially disfiguring surgery for the many patients who require of them each year we.

We are pleased that concurrent with the asthma presentation. These data were published in the New England Journal of Medicine.

Regarding next steps, we are talking to regulators about possible pathways for labeling and potentially inclusion Nancy C N guidelines.

Also it has no we presented initial clinical data for scuba mathematics, or muck 16 by C. Three by specific developed for advanced ovarian cancer Ah first clinical data for a C. Three by specific in a solid tumor.

And heavily pretreated ovarian cancer population, we observed durable responses.

To this muck 16, Bucks 83, mono therapy, and a patient subset, whose tumors over express must 16 response rates were as high as 31% most.

Most of the treatment and Virgin adverse events occurred with the initial step up dosing.

But madam map being developed as a monotherapy as well as in combination with reptile as well as in combination with our <unk> coasting Bispecific, we're looking forward to more data across these programs in 2023.

<unk> investor presentation.

We shared more detailed data for a P. SMA buy C. D 28, coasting by specific in combination with with tile representing the first efficacy and safety data for this new class of Bispecifics, which we had initially topline in disgust at our second quarter earnings we.

We have since continued to enroll patients in this study and we're planning to present updated data at a medical meeting in the first half of 2023.

Regarding our hemo pipeline, we're looking forward to data from a drew next I'm in our city 20 by two three by specific as well as Limbaugh Seltzer man or be CMA by C. Three by specific at the American Society of Hematology or Ash annual meeting in December .

For what your next to me I will present pivotal phase two data for both Follicular lymphoma, and diffuse large piece of lymphoma in two separate oil presentation. Upon discussions with the FDA. We are now targeting a second half twenty-twenty regular the regulatory filing for this program, we hope to initiate combination studies.

With an appropriate CD, 20th coasting bispecific in the near future.

For Linda self demand are Bsing me by T. Three buses to begin in body remain on track with development and are planning to file pending discussions with the FDA in 2023, we have now completed enrollment potentially pivotal phase two study as.

As I mentioned earlier data from this study will be updated ash.

As with out your next demand we're planning on initiating combination studies for Limbaugh sell to map with coast inventory Bispecifics in the near future.

We believe existing standard of care therapies leaves significant room for improvement in the difficult to treat settings.

Been encouraged by the interim efficacy and safety data, we have generated a date for both of US Your next to map in limbo supplements.

Finally had asthma. We also shared initial data for are met by net.

<unk> specific antibody and met altered non small cell lung cancer responses were enriching patients with higher levels of met expression no dose limiting toxicities were observed.

Even the modest over expression of met May render lung cancer susceptible to this mechanism of action and we're looking forward to the met by met antibody drug conjugate data next year.

In summary for oncology.

Rich Communist oil pipeline is delivering competitive data and with our full ownership of Libtayo. We're excited about the potential to advanced standard of care in oncology with our portfolio approach.

Concluding with the Regeneron genetics medicines efforts, where we continue to progress our pipeline and discovery engine in September when L. Niland reported promising data from our ongoing phase one study of Alnylam HST in non alcoholic Seattle hepatitis or Nash, we're planning on initiating a phase two study shortly.

Which is just one part of a multi pronged approach exploring multiple genetically validated targets for Nash.

Also in September when in telling announced initial data from the cardiomyopathy arm of our ongoing phase one study of.

N T L. A 2001 and investigational crisper based therapy for the treatment of transfer I've eaten amyloidosis, which show deep and sustained mean serum PTR reductions of over 90% was generally well tolerated.

Finally in October collaborators, a decibel therapeutics announced F D. A clearance for an NDA application for D. B O T. O R. First virally delivered gene therapy product candidate designed to provide hearings individuals. So it'll fairlon related hearing loss. This IMD provide clearance to initiate a pediatric space.

One two clinical trial in the United States with that I will turn it over to Marion.

Third quarter performance reflects changes and grabbed the class that commercial portfolio, we continue to expand our leadership position and my personal favorite category is part of our commitment to to live a life changing medicines to patients who need.

Webster.

<unk> and Quatre nationalize, let tolerance.

The principal in combination with chemotherapy in first lineup and non small cell lung cancer and recent data demonstrating the compelling profile of a flipper stuffed eight milligram <unk> commercial business at this point just don't live very long term growth.

Starting with the App, which reached 2.4 billion and come up on that sounds for the third quarter. This represents an 8% increase on a constant currency basis.

Michael Achievement for brand launched 11 years ago.

Ross.

<unk> 11 per cent you over here.

1.63 billion should again achieve over a million interactions in the corner.

The overall, 2% sequential category decline in volume from the second or third quarter of 2022.

She needs to grow across all indications can you share from both Brandon Nonbranded agents in fact.

All time highs and category sharp approximately 50% of the commandos, 75% share in the front of the category.

Continuing to strengthen and extend ambiance leadership position on an empty such a category.

She recently announced.

Granted pediatric exclusivity finally.

Extending the period of the value of your rest of market exclusivity primary additional six months.

17 2024.

Simpson and some positive phase previous else earlier, this year first and widespread excitement in the retina community.

Eight milligram dataset flip, except eight milligrams potential to become the future standard of care.

Approved.

Next to reptile.

Total global Panic sales were $143 million 25 per cent on a constant currency basis, and the U S. Much sounds pretty 21% to 95 million a phone call with an hour long and non.

Melanomas game indications, we see particular opportunity for growth in lung cancer overtime in monitoring.

Already study increases in prescribers total utilization, where lunch ready for the potential chemotherapy combination approval, which significantly expands the patient opportunity.

And finally to the.

Third quarter goes on that sounds were 2.3 billion up 45% on constant currency basis.

45% to 1.8 billion by robust demand across atopic dermatitis, asthma and meaningful polyps Christmas Austin, driven by a rapid launch trajectory cost recent indications, including it's anything like esophagitis in pediatric atopic dermatitis.

Only biologic to be obtained from infancy to adulthood.

Starting with dermatology any type of dermatitis depiction of leaving first line systemic therapy with strong uptake across the spectrum of moderate to severe disease.

Cross the age groups.

Ongoing lunch in children as young as six months as professionals value around providing at least the children and their families as well as reinforcing my safety protection for all age groups.

We've also expanded depictions leadership in dermatology following its approval and talk about your life. It takes them. Finally F. D. A approved medicine for this chronic debilitating skin disease that affects approximately 75000 adults me laugh early lunch indicators of positive for patients already being initiated on therapy.

He takes an author continued to perform well and highly competitive with asthma market steady growth in prescription to new patients starts as well as a means of pilots early lunch perform intermissions health Esophagitis has been very strong with brought adoptions without gastroenterologist, an allergist the medical community has embraced depiction.

<unk> previous for some very limited options, particularly early medicine indicated to treat as soon as stomach esophagitis unless the only.

Only treatment shown to address the underlying disease causes resulting in unprecedented symptom relief there approximately 50000 adults and adolescents Haitians in the U S and we continue to advance or clinical efforts in younger patients were substantial unmet need remains.

Outside the U S depiction.

Sales were 506 million coins, 44% on a constant currency basis, there was rapid uptake across approved indications and we continue to execute on recent launches and expand into new geographies.

Part of this regeneron increase presents <unk> international markets supports efforts to bring depictions even more patients.

In conclusion.

They're quite a performance demonstrate strength includes the costs are commercial portfolio. We were successfully executing on initiatives to deliver life changing medicines to patients in advance and strategies to maximize new and upcoming launches.

Commercial portfolio disposition, well she tried to long term sustainable crowds.

Now I'll turn the car to Bob.

Thank you Marianne my comments today, I'm Regeneron financial results and outlook will being a non-GAAP basis.

Unless otherwise noted regeneron performs well in the third quarter with growth from key brands and execution across the business continuing to drive strong financial results on both the top and bottom line.

Excluding global revenues related to the COVID-19, anybody cocktail third quarter total revenues increased 11% year over year 2.9 billion, demonstrating continued growth momentum from our core business and reflecting the favorable impact of the lip taio transaction.

Third quarter total diluted net income per share was $11.14 on net income of 1.3 billion.

Beginning with collaboration revenue in starting with bear third quarter of 2022 X U S slightly in that product sales were 817 million up 4% on a constant currency basis versus third quarter 2021, total bay or collaboration revenue was 333 million of which 315 million related to <unk>.

Eileen net profits outside the U S.

Total scientific collaboration revenue was $711 million in the third quarter of 2022 and grew 22% from the prior year driven by depiction.

Recall that and connect you with the <unk> transaction, we increase the repayment of our antibody collaboration development balance from 10% to 20% of antibody collaboration profits a portion of the step up is recorded as a reduction to antibody collaboration revenues. While another portion is recorded as.

R&D expense.

Given regeneron is now recording is full 50 per cent share of antibody collaboration R&D expense as incurred previously regeneron had only recognize the partial sheriff at Santa body collaboration R&D expenses incurred with the remaining share of expenses added to the antibody development balance.

Also as we highlighted last quarter in accordance with the agreement we recorded a one time development balance repayment of 57 million as an incremental reduction dishonesty collaboration revenue in the third quarter of 2022.

We have posted tour website supporting materials to further explain the accounting associated with this and other elements of the lip taio transaction.

Moving now to our operating expenses R&D increased 38% year over year to 817 million, partially driven by the impact of the lip taio transaction, which affects R&D in two ways first Regeneron now records all R&D expense reptile, which was previously shared equally which Santa fee second as I mentioned earlier regeneron.

How records are full 50 per cent share of antibody collaboration spend for depiction and Mister <unk>.

Is she an expense increased 20% year over year of $467 million, primarily driven due to incremental costs related to assuming global rights to lift taio.

Cost of goods sold in the third quarter was $109 million and product gross margin in the quarter increased the 94% as compared to 90.2% in the prior year. The more favorable gross margin was driven by the non-recurring <unk> sales in the current period in the removal of the payment to <unk>.

<unk> for their share of U S lip taio gross margin.

Finally, the third quarter of 2022 effective tax rate was 12.1% compared to 10.8% in the prior year.

Shifting now to cash flow and the balance sheet.

Year to date in 2022 Regeneron is generated 2.9 billion in free cash flow and ended the third quarter of 2022 with cash and marketable securities less debt of approximately $10.3 billion.

We remain focused on leveraging our strong financial position to deliver long term value for shareholders over the first nine months of 2022, we have deployed in excess of 2.8 billion in capital. We have executed approximately 1.2 billion in business development initiatives, including the 900 million dollar acquisition of law.

<unk> writes. Additionally, we have repurchased over $1.6 billion of our shares including over $900 million in the third quarter alone.

As of September 30th we had approximately $1.2 billion remaining on our current share repurchase authorization and we remain opportunistic buyers.

As we approach the end of the year, we've made some minor changes to our 2022 guidance ranges a complete summary of our latest.

Full year financial guidance is available in our press release issued earlier. This morning. In addition to these changes I would also like to provide some initial thoughts on our 2023 expense outlook we.

We continue to make investments go advancer pipeline and position the company for long term growth, we expect R&D investment to grow in 2000 twenty-three comparable to or slightly above the nine months a year to date growth rate reported earlier today the <unk>.

Incremental R&D investment in 2023 will be driven by advancing are immuno oncology.

<unk> immunology in genetics medicine pipelines as well as the continued expansion above art R&D organization. In addition, 2023 will be the first full year, reflecting the impact of the lip taio transaction.

Where we recorded 100 per cent of the global R&D spend for lip title and are full of 50 per cent share of the Santa fee antibody collaboration R&D spend as incurred for.

For SG&A in 2023, we currently project growth in the mid teens versus 2022, given will be recording a full year of global Libtayo expenses, along with targeted investments in the build out of our international infrastructure.

Finally for other operating income and expense in the third quarter of 2022, we recognize the remaining $44 million of deferred income related to previously received upfront payments and develop development milestones for <unk> as a result of the program discontinuation, we do not currently expect any <unk>.

<unk> other operating income or expense in the fourth quarter of 2022 in 2023 and beyond <unk> any new transactions and conclusion Regeneron has performed exceptionally well in the first nine months of 2022, and our strong financial position enables continued investment to drive long term growth.

With that I will pass the call Dr. Ryan.

Thank you Bob to one of this concludes our prepared remarks, we'd now like the open the call for Q&A.

With the number of colors in the queue I'd like to ensure we are that are enable are able to address as many questions as possible. As a result will only be able to answer one question from each color before moving to the next to Wanda. Please open the call for Q&A.

As a reminder to ask a question you would need to press star one one on your telephone please stand by while we compiled the queue and I lost it.

First question comes from the line, that's Evan Stinker Man with me I'm. All your line is open.

Hi, guys. Thank you so much for taking my question. Thanks, Congrats on the progress so with nearly 13 billion on the balance sheet and minimal that can you provide more color on your capital allocation priorities would you consider business development on a larger scale and are issuing a dividend.

Hi, Good morning, it's Bob.

You know with regards to the capital allocation and you know <unk>.

Demonstrated today by you know our growth and R&D in their 2023 forward guidance. We're gonna continue to invest first and foremost in the R&D pipeline that we have you know we issued our 10-Q. This morning within the MD&A, you'll see a plethora of trials that are currently ongoing in as George mentioned in his script.

Every bullish with regards to what is in the pipeline now again with regards to business development, it's not an enduring or right. As you saw on what we've done in the first nine months of 2022.

Where we do think there are opportunities and where we do think we can do collaborations where one plus one is three then were absolutely absolutely going to take that.

Take that opportunity to and I think check me. It was a good example of that and you know I I would expect that you'd see more of that with regards to your question on dividends. You know, it's it's never never you know obviously that that tool is in our tool chest. If we do decide to play that card as of right now we don't have dividends in the foreseeable future in our plan we have.

It's been very opportunistic with regards to buy backs again the M. D. N. A issued earlier today. The 10-Q will show you what we've been buying back our shares again will remain opportunistic buyers and we do have a remaining 1.2 billion remaining under our current 3 billion dollar authorization.

Thanks, Bob the Wanda please having a question on please.

Thank you please stand by for our next question.

Our next question comes from the line of Tyler Van Buren, with calling your line is helping.

I got a good morning, congratulations on the great quarter. So I just pulled up the odor next to my I have an <unk> 458, mash ups trucks and it'd be great to get a brief preview from you guys and what you need what you believe you ultimately need to show at the conference to be competitive relative to what other friction.

Yeah, I don't think we want to stoop ourselves, giving them at the conferences coming up pretty soon Tyler.

But you know <unk>.

It has the potential of being a very important molecule. We recognize that there are some people ahead of us and we recognize that some of the most recent timelines are pushed back a little bit based on recent regulatory feedback.

You know the the regulators have recently been focused on having phase three trials substantially enrolled at the time of submission.

Before the Grand accelerated approval, but we are confident in the profile of older next to Matt and as George says, there's also the future possibility of combinations with other things in our pipeline there could barely even leapfrog.

Thanks, and then next question please to Wanda.

Thank you.

Please stand by for our next question.

Our next question comes from the line AB Salving richer, what Goldman Sachs Your line or something.

Good morning, Thanks for taking my question Uhm on Eylea, what are you serving in the market between yourselves <unk>, but that's not much.

They're happy to give more characterization as I mentioned, we see India continuing to perform extremely well, reaching all times high category, Sharon, 60% and now you know, it's wild growth and the overall branded Marquette, where we participated with other brands of agents, including reddish.

One thing I want to mention just to give a bit more insight is that I can.

India captured.

Growth coming primarily from list Sanchez and also from <unk> and in fact, you know can you put the race portfolio together <unk>, obviously with positive while there was a decline in overall market share for the rash products combined.

Thank you Mary and next question Tijuana.

Thank you please send off our next question.

Our next question comes from the line Matthew Harrison with Morgan Stanley . Your line is okay.

Great. Good morning, Thanks for taking the question, Georgia I was wondering if you could just comment on your outlook for the C. O P. D study for Dupixent and how you think about that market opportunity. Thanks.

I was silly COPD has been a very difficult disease for new therapies and biologics in particular.

We think that there is a category.

Patients with COPD, who have or are marked by more what we call th two type inflammation we.

We think that as I said in my remarks that there was this unifying hypothesis that there are a lot of.

Teach two types of diseases that manifest in different ways.

We believe that this subset of patients with COPD may may be or fit into that category.

And.

And being able to benefit these patients.

And so either reducing their exacerbations and or improving their long fun.

Action would really make a difference to these patients.

And so we're.

And you know anxiously awaiting the data and we are hopeful that we will have another set of patients where we might be able to demonstrate that dupixent could really make a difference.

Thanks, George two onto the next question.

Thank you one moment far next question.

Our next question comes from the lineup Tim Anderson with for research your line or something.

Well thank you so much.

Lily will be launching library cause I'm, having twenty-three and a topic term and they updated it looks comparable to dupixent.

At least in this one indication pretty much a direct competitor.

Although not identical on mechanism. They know the term space because of toilets and the positioning is going to be that they can do this every month versus dupixent, which is every two weeks.

So I'm wondering if you have any strong views on that product or if you think that's going to be a total non-starter, which is pretty much the consensus view I guess.

Made me married can comment on it, but but there's room for competitiveness Margaret in this market. We're we're really modestly penetrated.

And the opportunity I I don't think that the profile, but you say is actually gonna be so far we've seen so far the all that similar we have the earliest from infancy already to adulthood. That's a big deal. Okay. In addition to the fact that many of these people have other comorbidity.

These whether it be asthma or nasal pilots for example, and they can get if they do have comorbidities a single drug can treat vote is very big.

Differentiate us so I think when you're in the market leader. When you were so far ahead. When do you have really a differentiated profile did you have an advantage obviously lily to find company.

Know, what they're doing but as I said this room frequently when Ah new Ah good drugs come to market. There is a growth of the market.

We're not going after fixed time of patients were actually growing those patients married I don't know if you want it.

You know I would just add that on.

D T opinion leaders that we speak to recognize that the dual mechanism of action the anti al for a cup of like anti all 13 is very very important that's certainly efficacy shouldn't be assumed there's lots of reinforcement not be incredible efficacy that's seen for patients with moderate to severe disease.

And obviously real world experience is compelling.

Station.

It was really quite straightforward, it's south of administration, and we actually see there the application of parent involvement.

Very helpful in establishing it makes sense, but that's certainly has learned mentioned expanding the application and category to bring my topic German type of patient treatment continuum is very positive for patients.

Certainly not.

Not to pile on but since [laughter] just to add on to what Len was saying I mean, the fact that the aisle 13 have failed.

These other important th two inflammation driven diseases like asthma and like C. O P D and others right now really does suggest that they are not fully addressing the th two inflammation.

Both in any one particular disease, but also is Lin said so many of these individuals. If you you just look at our label or any label that describes these diseases. They suffer from other allergic comorbidities and so obviously can make such a difference for a patient where one.

Drug can treat a systemic diseases posted treating the disease only in one of the many compartments, where it manifests itself I think this is the way I think medicine in the fields should be moving this is a systemic disease, where th two inflammation is probably ramp and in many compartments in the body.

You don't only want to treat it in one compartment and you want to treat the entire body and that's what we've been showing systematically by going one disease. After another with Dupixent. It works in every compartment Ah and it broadly attacks the underlying inflammation.

That's related and positive in all of these diseases.

Hey, Thank you for that response to Wanda can we go to the next question.

Thank you please stand by for our next question.

Our next question.

She comes from a line of Mohit Manchild with Wells Fargo. Your line is open.

Great. Thanks for taking my question and congrats on the progress if.

If I could prove little bit farther on the comments made about the growth of Endeavour just market you say, it's about 4% year over year seems like beta slow down from what the high growth. We have seen could you elaborate further do you see.

Just one quarter do you see any underlying trend there and is it because of the high growth be salt plus Hulu, which is taping down if you could help us understand that thank you.

Yeah, and I I think it's very difficult to extrapolate one quarter, certainly I did mention that there'd been a sequential decline of about 2% going from the second quarter inch of the third quarter in the overall antique that just category and I think it's really difficult to extrapolate from that the numbers you shared an overall.

A year growth of category at about 4%, we recognize as well I think we'll have to see as that I spent more time goes by that it's really difficult to draw conclusions on what may or may not have occurred in a one quarter period.

There's still quite a daunting a room.

Quite a bit of room of growth in the diabetic eye disease.

Where were we still see a decent group that.

In that category has blissfully. Thank you.

Next question. Thank you. Thank you landing Marianne and my next question. Please till one though.

Thank you please stand by for our next question.

Our next question comes from Christopher Raymond what type of <unk>. Your line is helping.

Hate. Thanks, just another question, maybe on the digest market and Eylea specifically.

So in our checks.

Get a sense that there's some docs, who believe that buh buys what confers differentiated efficacy.

But on the other hand, there's still a sizable amount of dogs, who have yet to see a patient for follow up after the the first dose sort of just curious if in the field you're seeing a difference in perception.

Ah Verizon I'll buy time of experience that is you know any discernible change your perception of the more peace you follow up they'd have.

And I I think it's probably best setup rash answer questions on what they're hearing about each I'll just share at this point I haven't heard characterization of that he's still at a low level in fact quite modest I can characterize ban me a performance as I did in terms of market leadership and Nicole.

We see in our business in terms of market share and other parameters and that is a cross indications and certainly substantially creating idea as leader in the entered that Jeff category. You know obviously with I includes the asset gasolines threatened community properly even more important about the possibilities and potential lover.

Flipper step eight milligram if approved in the future.

[noise]. Thank you Marian next question please.

Please stand by for our next question.

Our next question comes from Atlanta, <unk> call in Bristol with E. B S. Your line is open.

Hey, good morning, and congrats on the call Sir.

So O 923, we're starting to see some call me up day. So I was wondering could you just speak to how you see the market share evolving at a cost of 23 and <unk> and then obviously Biosimilars and then just as we think about hi, guys find there in the back half of the year anything you can say intensive anticipated <unk> <unk>.

Thank you.

So.

We don't predict future market share performance I'm gonna stay away from the specifics in that area certainly not only this quarter, but over several quarters, we've been able to demonstrate continuing strong performance.

And she got dressed category leader and certainly will continue to work on that and you know as as.

As agents have entered the market our competitors readiness abilities have been very strong, but most important frankly, it's the profile I Leah the the clinical attribute the safety of the product the breath of indications.

Ease of access for physicians and patients, but but going forward certainly will be very much prepared to launch a flipper steps eight milligram.

As we get into that launched potentially with a nasty approval will be able to give more characterization that is jewelry Chang Lin described today the profile received with a flipper step eight milligrams and opinion leaders in the retina community.

Confirm that this this profile potentially has all the ingredients to become standard of care and certainly that's what will work on all the benefits of vision Cup over safety and Nowadays you know potential a substantial durability it hasn't been seen before in the category.

Collin, it's Bob with regards to Opex, you know what I mean.

And I will do what we always do on the brands will look at what totally makes sense I mean as you know it's kind of defined number of retinal dark so it's not as if we're going into a tremendously new area that creates a lot of new touch points on it.

And on top of that you know Marion's team right now is very tight functioning sales rep team on the top of their game. So again, we don't expect some gigantic tibbets on in this area, but again, we will make sure that we we fund this appropriately and that it it it is.

The commercial side of it is going to match, how well the clinical data is gonna stand up on it. Thanks.

Thank you New Mexico next question. Please [noise].

Thank you please hang by far next question.

Our next question comes from the line up Bryant Abrams flipped RBC alarm insulting.

Hey, good morning, Thanks for taking my question and got congrats on the continued execution and innovation on the prostate by specific now that you've had more time with the evolving data any views unpredicted, if responsive to our ability there and I'm curious how your learnings my shape your latest thoughts on training the therapeutic window boats for the P. S. M. A as you accelerate the <unk>.

Trial enrollment as long as your other posts similarly, tori by specifics thanks.

Yeah I.

I think that.

Our data actually shows that with the remarkable response rates, we saw especially going to the higher doses that.

It's not as if you have to look hard to find bio markers.

Four response remember just to remind you that at the highest dose three out of the four patients had.

Very profound responses.

So response.

Predictor are not necessarily the issue, but you also point to the question about therapeutic window certainly.

Seeing auto immune related side effects.

Associated with these responses and so we are working hard now we are actually we've accelerated.

Alright enrollment in this program, we are trying to understand more of the relationship between the responders and having these are the main side effects I mean, one.

Very.

Positive perspective, as we don't see the serious side effects and people, who don't see responses. Those are the people who benefit who do get the auto immune side effects, either obviously, coupled it's because I think the drug is doing what we intended to do I think this is some of the most exciting data in the history of immunotherapy.

You can take where people have historically called a cold tumor that has almost no responses to immunotherapy repeating one therapy and get these incredibly high rates of very deep and so far durable responses.

And we will continue to work on <unk>.

Improving the therapeutic window in terms of the devices to reprogram more broadly and I wanted to hearken back learn learn sort of answered the previous question about <unk>, but I do want to amplify.

On some of his comments, which is.

We think that there are indeed, a very small number of by specs and the CD 20 space in the <unk> space, which are actually looking quite competitive with each other including hours. So the emerging data suggest the efficacy and safety profiles of these agents will.

It will be competitive with each other you will see are updated data will presented at ash.

So I think that there's going to be room for the small numbers of competitors there, but the future is going to be about moving into earlier lines of therapy.

There's going to be subtleties, there about how one executes designs those studies the coast therapies more standard co therapies that are used there and so there's gonna be a lot of accidentally art to how one moves these agents into the earlier lines of therapies, but the other very important thing is in addition to moving into Earth.

Other lines of therapy with these more standard combination, whereas I said, there's gonna be a lot of art to doing those studies.

B as a novel combos and as we just talk about with the CD 20th coasting by specifics that we have now shown that we're leading the field with.

In prostate cancer, we have very similar type agents now that we're going to be combining with our CD 20, bispecific and lymphoma and with our be CMA Bispecific and myeloma and we think that these are going to really have the opportunity to continue to change.

The game and change the practice of medicine for these patients. So so it's about taking.

Taking agents that R&D is going to be competitive in quite competitive with each other and these late stage settings, where I think they're all going to be making important contributions to the treatment of these patients, but then moving.

And.

Very Ah Ah artful ways to these earlier lines of therapy and using them there where I think there's also gonna be room, but there's always going to be room for differentiation as well as the future. We're making these combos with all of these exciting opportunities we have in our portfolio can really.

Take.

The utilization of these agents in the treatment for these patients in these Kansas to a whole nother level as we believe we're already showing that we're doing in prostate cancer.

Torture and there was one question about Biomarkers in prostate cancer, maybe you might comment on how quickly you can use Psa.

Studies after the paperwork exposed to prophage or.

And and some of the day, we've already shown.

And we will continue to show.

Many of our patients have remarkably high PSA level, because they have very high burden of disease as we all know depending on the assay in the lab and so forth normal PSA levels are in the single low single digits.

Maybe one to four is considered the highest levels, we have patients who entered into our study with PSA isn't the hundred 500, 600, and so forth and.

And we saw with this combination treatment as soon as you put the combination onboard Sn.

Essentially it the next time point that we measured within three weeks or so we saw a dramatic drops of on the order of 99% reduction in the PSA and he's a really astounding results in now where we've continued to follow up patients over time, we've seen that for example, bone lesions have entirely normalize and.

So forth. So the effects are incredibly rapid as reflected in the PSA.

And to the point about predicting which patients respond it doesn't matter, whether you had patients who had relatively low burden as measured by PSA where their PSA was measured in the in let's say 40 to 50 range or whether you had incredibly high PSA and ER five to six.

Hundred range.

Those patients seem to similarly respond in terms of very dramatic very profound drops in the PSA within weeks of starting therapy.

And as we've continued to follow these patients incredibly durable responses are first patient has now been out for more than a year.

They're noon side effects have resolved, whereas they are complete remission has remain completely intact and as I said not only completely normalise, the PSA levels, but the bone lesions and so forth have all normalize at least as measured by bone scan.

And so forth. So this is really has the potential to be so game changing for the late stage patients who really have at this point no other real recourse.

Thank you letter to George I think we have time for one more question.

Wanda.

Thank you please stand by for our final question.

A final question comes from the line of Quatre Gould with Barclays. Your line is open.

Hi, Good morning, Thanks for taking switching me and taking the time, maybe just to come back to for Marianne How we should think about your expectations for the timeline to receive a J code for hydro assign Leah you know next year, we've seen in the past you know pretty very timeline sure in terms of like got there is turned around almost.

Mainly Roche clearly had more paste process and I guess more to the point should our expectations. That's more of like a January one 2024 type of event towards the potential for a J code maybe in the later part 23. Thank you.

Alright, Thank you for the questions and certainly well stay very close on this and you know obviously the important stuff.

<unk>. It is important in terms of timing I would need a crystal ball certainly would share with you will be working very closely with the the proper organizations and officials that at this time, it's too early to give anything definitive on an expectation for Jake her tiny yeah. In this land I mean, my own perspective on their slightly.

But I'm not convinced in this particular setting that the J code or there's like the end all be all of.

Ah Ah like you're Gonna see these dramatic changes and upticks Ah Ah.

J codes.

Well thank you.

Mm.

I I think that's all we have time for today. Thank you everyone for joining the call is always the Investor relations is standing by for any follow.

Follow up questions you may have.

Have a great day everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

The conference will begin shortly to raise your hand doing <unk> you can dial 911.

[music].

Hello, and welcome to Regeneron Pharmaceuticals third quarter 2022 earnings conference call.

My name is to Wanda and I will 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 to ask a question. During the session you will need to press star one one on your telephone.

Please note that this conference is being recorded.

I'd now like to turn the call over to Ryan Crowe, Vice President Investor Relations you may begin.

Thank you to Wanda good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron and welcome to our third quarter 2022 earnings Conference call. An archive of this webcast will be available on our Investor Relations website. Shortly after the call ends.

Joining me today are Dr. Leonard Schleifer, founder President and Chief Executive Officer, Dr. GA on topless co founder President and Chief Scientific Officer, Marion Mccourt Executive Vice President and head of commercial and Bob Landry Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

I would also like to remind you that remarks made on this call. Today include forward looking statements about regeneron such statements may include but are not limited to those related to regeneron and its products and businesses business financial forecasts and guidance development programs and related anticipated milestones collaborations finances regulatory matters.

Payer coverage and reimbursement issues intellectual property pending litigation and other proceedings and competition.

Each forward looking statement is 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 in regeneron and <unk> filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended September 32022, which was filed with the SEC. 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 that GAAP and non-GAAP measures will be discussed in today's call information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial result.

The press release, which can be assessed access on our website.

Once our call concludes Bob Landry and the IR team will be available to answer further questions.

With that let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer Len.

Thank you Ryan and thank you to everyone joining today's call Regeneron.

We generally strong operational momentum continued in the third quarter highlighted by important developments across our pipeline and outstanding commercial execution.

Before diving deeper into our commercial results I'd like to review some of the recent progress we have made across our pipeline.

Starting with the striking pivotal data that we reported in September for our investigational <unk> eight milligrams, which we believe could ultimately transform the treatment landscape for patients.

With nearly 90% of <unk> patients and 80% of wet AMD patients able to sustained 16 week maintenance dosing through 48 weeks of treatment.

We believe a flip is at eight milligrams may shift the current treatment paradigm with more patients receiving last week when injections, while achieving visual acuity gains anatomical improvements and a safety profile comparable to eylea.

Recently approved anti VEGF agents did not demonstrate in pivotal studies that the majority of patients in either disease, we were able to sustain 16 week maintenance dosing throughout the first year of treatment supporting our view that it flips at eight milligrams has the potential to become the next generation standard of care.

I bet, you have treatment assuming regulatory approval.

Relaunched planning is already underway with a potential FDA approval by late August 2023.

In addition to the pivotal a flipper set at eight milligram data, we generally continued to make notable progress.

Immunology and oncology pipelines, starting with immunology in September we received FDA approval for <unk> and <unk>. The first systemic therapy for this indication and the fifth disease for which the picks and is now approved.

So far this year depiction has received for U S or EU regulatory approvals expanding the treatment eligible population by approximately 225000 patients including in two diseases that previously had no FDA approved systemic therapies.

In the first half of next year, we're looking forward to EU regulatory decisions for eosinophilic, Esophagitis, where I go Nigel Arris, and atopic dermatitis and patients as young as six months with these potential additional indications.

<unk> 200000 more patients with these type two inflammatory diseases could benefit some depictions unmatched clinical profile.

Additionally, we expect pivotal data readouts for depiction in chronic inducible cold Arctic area and quite a chronic obstructive pulmonary disease and the first half of next year.

Moving to oncology, where the depth and breadth of our pipeline has positioned regenerative to ultimately become a global leader.

We presented several data sets at this year's European Society for medical oncology annual meeting further underscoring the importance of lids tile as the foundation for our overall oncology strategy.

George will review the data in more detail during his remarks, but we were particularly encouraged by the results for live try on monotherapy and neo adjuvant setting as well as the title in combination with fan the mab or lag three antibody in first line metastatic melanoma.

We also presented monotherapy data for our March 16 by CB, three bispecific and recurrent ovarian cancer, which has the potential to be combined with the tile as well as data for our met by met bypass topic Bispecific and met all the non small cell lung cancer.

I'd also note the early but very exciting results for a P. SMA by CD 28, co stimulatory bispecific in combination with a tile which showed promising anti tumor activity in patients with advanced metastatic castrate resistant resistant.

Class eight calls.

The patients enrolled in our study.

A poor prognosis with an expected survival of one to two years, depending upon their treatment history.

Given prostate cancer has been largely unresponsive to PD one inhibition in immunotherapy in general there is a clear need for new treatments in 2020 alone there were over 375000 deaths globally from prostate cancer and it was the second leading.

Cause of cancer death in American Man.

We continue to expand our co stimulatory by specific efforts in prostate cancer with an acceleration in enrollment in our first in human study since we reported topline results in August and we look forward to updating you on this program in the first half of next year.

Now turning to our commercial performance in the third quarter Eylea Global net sales grew 8% at constant currency to $2 4 billion in the U S. Eylea net sales were 1.63 billion up 11% year over year and outperforming the anti VEGF category growth of only.

4% despite.

Despite recent granted and Biosimilar entrants I leave I set a new all time high for anti VEGF category share in the United States.

The business continued to grow at a remarkable pace bolstered by approvals in new diseases and younger patient populations and previously approved indications in.

In the third quarter global net product sales were $2 3 billion up 45% at constant currency compared to last year, reflecting growth across all indications and all geographies.

<unk> differentiated clinical profile and the ability to effectively treat more and more patients in both currently approved indications and potentially for additional type two inflammatory diseases is expected to drive strong growth in the future.

The child total net sales grew 25% globally at constant currency to 143 million in the third quarter, including 21% growth in the United States, driven by non melanoma skin cancer indications and monotherapy in non small cell lung cancer.

Out of the third quarter, we acquired global rights to live tie up from Santa Fe with potential future combinations, including with chemotherapy in non small cell lung cancer as well as other pipeline agents in development. We believe that Tayo is poised to become a more meaningful revenue contributor over time.

Hi.

We're excited about the strong commercial performance for our core products, the compelling efficacy safety and durability data that we reported a flip it's at eight milligrams as well as the notable progress we have made advancing our pipeline, particularly in oncology.

Our pipeline now includes approximately 35 product candidates in clinical development, including a number of marketed products that we're investigating for additional indications some of which George will discuss in a moment.

In closing our strategy continues to focus on investing in our internal R&D capabilities, while exploring potential collaborations that will enable us to fully realize the power of our science.

We remain confident in this strategy and in our growth prospects as well as in our ability to deliver breakthroughs to patients and value to shareholders now I'll turn the call over to George.

Thank you Lynn.

I'll start with ophthalmology.

Positive pivotal results for Liberty sub eight milligram and the Pulsar and photon studies were recently presented at the American Academy of Ophthalmology annual meeting.

Results of these trials in wet AMD, and Danny respectively demonstrated that a remarkably high percentage of patients where a.

But to be rapidly initiated into and then successfully maintained through week 48, and 12 and 16 week dosing intervals.

Achieving vision gains that were not inferior to the current standard of care Eylea two milligram dosed every eight weeks. These results suggest that if libertad eight milligrams has the potential to become the new standard of care in these retinal diseases.

I think it would be helpful. If we step back for a minute and try to put these results in context, while our trial what our trials did was pushed the limits far beyond what has been accomplished with any currently available anti VEGF therapies.

Rather than using response criteria to try to identify where slowly extend patients to longer dosing intervals are trials tested whether all patients could be randomly assigned and rapidly initiated an extended dosing intervals of liberty steps eight milligram without compromising visual improvement.

Safety.

These are flip chip eight milligram trial accomplished just that for the vast majority while delivering a safety profile consistent with that of Eylea.

89% of DMD patients and 77% of wet AMD patients were able to be rapidly initiated and maintained on a 16 week of deliberate steps eight milligram dosing regimen, while 93% of Danny and 83% of wet AMD patients were able to be rapidly initiating maintained on at least a 12.

Week dosing interval, all while delivering efficacy similar to that of IV administered every eight weeks.

We believe these are truly unprecedented and potentially game changing results, which have not been achieved using any other anti VEGF agents.

Well. This is speculated that our pulsar and photon results were due to our dose modification criteria and even tried to theoretically extrapolate that their agent could have somehow approach. These results using our criteria.

We put these speculative extrapolation into the category of wishful thinking in.

And based on our expert analysis of the data we conclude it is all about the drug and not the trial design.

Briefly moving onto depicts and building on our recent approval in eosinophilic esophagitis in adults and adolescence.

We're planning on submitting a supplementary BLA for eosinophilic Esophagitis and went to 11 year old children in mid <unk> 23 to pyxis and ability to treat eosinophilic esophagitis highlight how important it is that our IL four IL 13 blocker more completely targets.

Tier type two inflammatory cascade and not only eosinophils.

As you heard Len mentioned, the FDA label was expanded yet again in the third quarter. It depicts and became the first and only treatment indicated for Prurigo Nigel Iris debilitating chronic skin disease. This marks the fifth disease for which depicts and has now approved a collective clinical data with depicts in support of unifying molecular.

Underlying these related diseases from asthma, APAC topic dermatitis to nasal polyps do prurigo natural arris to Athena.

<unk>.

And this unifying hypothesis IL four and IL 13 induced inflammation is driving all of these related diseases.

Different tissue compartments.

Moving to lip tayo in oncology in the third quarter, a robust oncology pipeline has started to deliver data readouts from our latest and most innovative programs and we are.

Expecting these readouts to accelerate in the remainder of 2022 may continue into 2020 three.

The European Society of medical oncology or ESMO annual meeting September was truly a banner event for regeneron with several notable oral presentations for assets in our oncology pipeline, which I'd like to briefly summarize starting with the element of lag three antibody in combination with time.

Note, we shared data from two independent advanced melanoma expansion cohorts, where my first in human study, which importantly showed consistent efficacy and safety between the two replicate cohorts the inland mab in combination with lip tayo demonstrated greater than 60% response rates in each cohort.

Our median PFS estimated to be 24 months across both cohorts and a median duration of response that had not yet been reached the preliminary safety profile of the combination appears to be in line with anti PD, one monotherapy and potentially with less toxicity compared to anti <unk> four combinations.

Well dual lag three and PD. One inhibition has previously shown promise in advanced melanoma response rates greater than 45% with median PFS of more than a year had not been previously reported. These initial results in melanoma suggest that <unk> combination as a potentially best in class.

Profile in this setting we're enrolling our phase III metastatic melanoma study, we intend to initiate a phase III adjuvant melanoma study later this year and have additional plans in other solid tumors, where fee element has the potential would be first in class.

The neo adjuvant cutaneous squamous cell carcinoma, or CFCC, a phase II study of lip Tayo monotherapy has shown promising results.

Given prior to potentially curative surgery and patients with large tumors. The tie was able to deliver major pathological responses to 63% of patients prior to surgery.

This raises the possibility that <unk> could decrease the burden of these major and potentially disfiguring surgeries for the many patients who required them each year we.

We are pleased that concurrent with the ESMO presentation. These data were published in the New England Journal Medicine regarding next steps, we're talking to regulators about possible pathways for labeling and potentially inclusion Nancy C and guidelines.

Well also at ESMO, we presented initial clinical data for <unk>.

<unk> 16 by <unk> three by specific develop for advanced ovarian cancer, our first clinical data for our C. Three bispecific in a solid tumor.

In heavily pretreated ovarian cancer population, we observed durable responses.

To this muck 16 by CD three monotherapy in a patient subset, whose tumors over express <unk> response rates were as high as 31% most of the treatment emergent adverse events occurred with the initial step up dosing, but man-to-man being developed as a monotherapy as well as in combination with reptile.

As well as in combination with our MX <unk> co stim Bispecific, we're looking forward to more data across these programs in 2023.

<unk> investor presentation.

We shared more detailed data for a P. SMA by CD 28, co stim Bispecific in combination with Lyft Tayo.

Representing the first efficacy and safety data for this new class of Bispecific, which we had initially topline and discussed at our second quarter earnings. We have since continued to enroll patients in this study and we are planning to present updated data at a medical meeting in the first half of 2023.

Regarding our hemo pipeline, we're looking forward to data from <unk> demand or CD 20 by two three by specific as well as limbo Cellcom, an RBC made by C. Three by specific at the American Society of Hematology or Ash annual meeting in December .

For <unk>, we will present pivotal phase II data for both Follicular lymphoma, and diffuse large b cell lymphoma in two separate all presentation's upon discussions with the FDA. We are now targeting a second half 2020 regular regulatory filing for this program, we hope to initiate combination studies with <unk>.

With an appropriate CD 20, co stim bispecific in the near future.

For Linda South of Mab RBC made by T. Three bispecific antibody, we remain on track with development and are planning to file pending discussions with the FDA. In 2023, we have now completed enrollment in a potentially pivotal phase II study as I mentioned earlier data from this study will be updated at ash.

As with our true next demand we are planning on initiating combination studies for both sell demand with co stimulatory bispecific in the near future.

We believe existing standard of care therapies. These significant room for improvement in these difficult to treat settings, and we have been encouraged by the interim efficacy and safety data we've generated to date for both <unk> and Limburg south of that.

Finally at ESMO. We also shared initial data for a met by net bi specific antibody in met altered non small cell lung cancer responses were enrich in patients with higher levels of met expression no dose limiting toxicities were observed.

Even the modest overexpression of met May render lung cancer susceptible to this mechanism of action and we're looking forward to the met by net antibody drug conjugate data next year in <unk>.

Summary for oncology.

Our rich combinatorial pipeline is delivering competitive data and with our full ownership of lip Tayo. We're excited about the potential to advance standard of care in oncology with our portfolio approach.

Concluding with our Regeneron genetics medicines efforts, where we continue to progress our pipeline and discovery engine in September we unveiled the island reported promising data from our ongoing phase one study of El <unk> Island HST in non alcoholic SEATO hepatitis or Nash, we are planning on initiating a phase II studies.

<unk>, which is just one part of our multi pronged approach exploring multiple genetically validated targets for Nash.

Also in September we in and telling you announce initial data from the cardiomyopathy arm of our ongoing phase one study of <unk>.

N T L. A 2001, an investigational CRISPR based therapy for the treatment of transfer Eaton amyloidosis, which show deep and sustained mean serum <unk> reductions of over 90% and was generally well tolerated.

Finally in October our collaborators of Decibel Therapeutics announced FDA clearance for an NDA application for D. B O T. O R. First virally delivered gene therapy product candidate designed to provide hearing to individuals' zoro Berlin related hearing loss. This IND provide clearance to initiate a pediatric phase.

<unk> clinical trial in the United States with that I will turn it over to Maryann.

Thank you George.

Third quarter performance reflects strength and growth across our commercial portfolio. We continue to extend our leadership position and my personal therapeutic categories.

Part of our commitment to deliver life changing medicines to patients in need.

With the pyxis approval and Kroger nausea lives, let's hires anticipated approval in combination with chemotherapy in first line advanced non small cell lung cancer and recent data demonstrating the compelling profile of a flipper steps eight milligram again on commercial business is poised to deliver long term growth.

Starting with Eylea, which reached two 4 billion and global net sales for the third quarter. This represents an 8% increase on a constant currency basis and remarkable achievement for a brand that launched 11 years ago.

Eylea net sales grew 11% year over year Q1, six 3 billion. So again achieved over a million injections in the quarter.

The overall, 2% sequential category decline in volume from the second to third quarter of 2022.

You need to grow across all indications gaining share from both branded and unbranded agents in fact.

At all time highs in category share of approximately 50% of commandos, 75% share in the branded category.

Continuing to strengthen and extend <unk> leadership position in the Andes.

Such a category.

We recently announced the FDA has granted pediatric exclusivity friendly.

Thereby extending the period of Eylea U S market exclusivity final additional six months through May 17, 2024.

Since announcing positive phase III results earlier. This year there has been widespread excitement in the retina community about the flipper set eight milligram dataset and it flips at eight milligrams potential to become the future standard of care is approved.

Next to Tayo.

Total global product sales were 143 million growing 25% on a constant currency basis in the U S. Net sales grew 21% to $95 million based on growth in our long.

Melanoma skin indications, we see particular opportunity for growth in lung cancer over time in monotherapy. There are already steady increases in prescribers and total utilization we are launch ready for the potential chemotherapy combination approval, which significantly expands the patient opportunity.

And finally to the pixel third quarter Global net sales were $2 3 billion up 45% on a constant currency basis in the U S. <unk> sales grew 45% to 1.82 billion driven by robust demand across atopic dermatitis asthma and nasal polyps growth was also driven by a rapid.

London trajectory across recent indications, including incentive pay like esophagitis in pediatric atopic dermatitis, where did you pick Tennessee, only biologic to be playing sort of infancy adulthood.

Starting with dermatology in atopic dermatitis. It takes it's a leading first line systemic therapy with strong uptake across the spectrum of moderate to severe disease.

The age groups the ongoing.

Ongoing launch in children as young as six months is progressing very well providing leads to children and their families as well as reinforcing the safety protection for all age groups.

We've also expanded the leadership in dermatology following its approval in Prague, and not allow us to pick some is the only FDA approved medicine for this chronic debilitating skin disease that affects approximately 75000 adults in the U S. Early lunch indicators are positive with patients already being initiated on therapy.

It makes it also continued to perform well in a highly competitive with asthma market with steady growth in prescriptions and new patient starts as well as in nasal polyps early launch performance and it sounds like esophagitis has been very strong with broad adoptions without gastroenterologist and allergists the medical community has embraced depiction.

<unk> previously had very limited options, particularly early medicine indicated to treat a senator like esophagitis honestly early treatment shown to address the underlying disease causes resulting in unprecedented symptom relief. There are approximately 50000 adult and adolescent patients in the U S and we continue to advance our clinic.

Efforts in younger patients were substantial unmet need remains.

Outside the U S depiction.

Net sales were 506 million growing 44% on a constant currency basis. There was rapid uptake of course approved indications and we continue to execute on recent launches and expand into new geographies as part of this regeneron increased presence in key international markets supports efforts to bring the picture into even more.

Yes.

<unk> third.

Third quarter performance demonstrates strength and growth across our commercial portfolio. We are successfully executing on initiatives to deliver life changing medicines to patients and advancing strategies to maximize new and upcoming launches.

Commercial portfolio is positioned well to drive long term sustainable growth now.

Now I'll turn the call to Bob.

Thank you Marianne my comments today, I'm Regeneron financial results and outlook will be on a non-GAAP basis.

Unless otherwise noted regeneron performed well in the third quarter with growth from key brands and execution across the business continuing to drive strong financial results on both the top and bottom line.

Excluding global revenues related to the COVID-19 antibody cocktail third quarter total revenues increased 11% year over year to $2 9 billion demonstrating continued growth momentum from our core business and reflecting the favorable impact of the lip tayo transaction.

Third quarter total diluted net income per share was $11.14 on net income of $1 3 billion.

Beginning with collaboration revenue and starting with their third quarter 2022 X U S. Eylea net product sales were $817 million up 4% on a constant currency basis versus third quarter 2021, total Bayer collaboration revenue was $333 million of which $315 million related to our <unk>.

With Eylea net profits outside the U S.

Total scientific collaboration revenue was $711 million in the third quarter of 2022 and grew 22% from the prior year driven by depiction.

Call that in connection with the lip Tayo transaction, we increased the repayment of our antibody collaboration development balance from 10% to 20% of the antibody collaboration profits a portion of the step up is recorded as a reduction to antibody collaboration revenues. While another portion is recorded as <unk>.

<unk> expense.

Given regeneron is now recording its full 50% share of antibody collaboration R&D expense as incurred previously regeneron had only recognize the partial share of its antibody collaboration R&D expenses as incurred with the remaining share of the expenses added to the antibody development balance.

Also as we highlighted last quarter in accordance with the agreement we recorded a onetime development balance repayment of $57 million as an incremental reduction to Santa Fe collaboration revenue in the third quarter of 2022.

We have posted to our website supporting materials to further explain the accounting associated with this and other elements of the lift Tayo transaction move.

Moving now to our operating expenses R&D increased 38% year over year to $817 million, partially driven by the impact of the lip tayo transaction, which affects R&D in two ways first Regeneron now records all R&D expense relived tile, which was previously shared equally with Santa feet second as I mentioned earlier Regeneron now.

Records are full 50% share of the antibody collaboration spend with depiction and has to pick them up.

G&A expense increased 20% year over year to $467 million, primarily driven due to incremental costs related to assuming global rights to lift tayo.

Cost of goods sold in the third quarter was $109 million.

Gross margin in the quarter increased to 94% as compared to 92% in the prior year. The more favorable gross margin was driven by the non recurrence of Virgin Coke sales in the current period and the removal of the payment to therapy for their share of U S lip tayo gross margin.

Finally, the third quarter 2022 effective tax rate was 12, 1% compared to 10, 8% in the prior year.

Shifting now to cash flow and the balance sheet year to date in 2020 to Regeneron has generated $2 9 billion in free cash flow and ended the third quarter of 2022 with cash and marketable securities less debt of approximately $10 3 billion.

We remain focused on leveraging our strong financial position to deliver long term value for shareholders over the first nine months of 2022, we have deployed in excess of $2 8 billion in capital we have executed approximately $1 2 billion and business development initiatives, including the 900 million dollar acquisition of lift.

Tayo rights. Additionally, we have repurchased over $1 $6 billion of our shares including over $900 million in the third quarter alone as of September 30th we had approximately $1 $2 billion remaining on our current share repurchase authorization and we remain opportunistic buyers.

As we approach the end of the year, we've made some minor changes to our 2022 guidance ranges a complete summary of our latest.

Oh year financial guidance is available in our press release issued earlier. This morning. In addition to these changes I would also like to provide some initial thoughts on our 2023 expense outlook.

We continue to make investments to advance our pipeline and position the company for long term growth, we expect R&D investment to grow in 2023 comparable to or slightly above the nine months year to date growth rate reported earlier today, the incremental R&D investment in 2023 will be driven by advancing our immuno oncology hematology.

Apologies immunology in genetic medicine pipeline as well as the continued expansion of our R&D organization. In addition to 2023 will be the first full year, reflecting the impact of the lip Tayo transaction, where we recorded 100% of the global R&D spend for lip tayo and our full 50% share of the Santa Fe.

<unk> antibody collaboration R&D spend as incurred.

For SG&A in 2023, we currently project growth in the mid teens for 2022, given will be recording a full year of global lip tayo expenses, along with targeted investments in the build out of our international infrastructure.

Finally for other operating income and expense in the third quarter of 2022, we recognized the remaining $44 million of deferred income related to previously received upfront payments and development development milestones.

For for cinema App as a result of the program discontinuation. We do not currently expect any material other operating income or expense in the fourth quarter of 2022 in 2023 and beyond absent any new transactions in conclusion Regeneron has performed exceptionally well in the first nine months of.

<unk> 2022, and our strong financial position enables continued investments to drive long term growth with that I will pass the call back to Ryan.

Thank you Bob to one this concludes our prepared remarks, we'd now like to open the call for Q&A.

With the high number of callers in the queue I'd like to ensure we have the earn able are able to address as many questions as possible.

As a result, we'll only be able to answer one question from each caller before moving to the next to Wanda. Please open the call for Q&A.

As a reminder to ask a question you will need to press star one one on your telephone please standby, while we compile the Q&A roster.

Yeah.

Okay.

Yeah.

Our first question comes from the line of Evan <unk> with BMO. Your line is open.

Hi, guys. Thank you so much for taking my questions and congrats on the progress so with nearly $13 billion on the balance sheet and minimal debt can you provide more color on your capital allocation priorities would you consider business development on a larger scale and are issuing a dividend.

Hi, Good morning, it's Bob.

You know with regards to capital allocation.

Demonstrated today by our growth in R&D in the 2023 forward guidance, we are going to continue to invest first and foremost in the R&D pipeline that we have we issued our 10-Q. This morning within the MD&A, you'll see a plethora of trials that are currently ongoing and as George mentioned in his script.

Very bullish with regards to what is in the pipeline now again with regards to business development, it's not an enduring or right as you saw and what we've done in the first nine months of 2022, where we do think there are opportunities and where we do think we can do collaborations where one plus one is three of them were absolutely absolutely going to take that.

Take that opportunity and I think checkmate was a good example of that.

You know I would expect that you'd see more of that with regards to your question on dividends. You know it's never never you know obviously that that tool is in our tool chest. If we do decide to play that card as of right. Now we don't have dividends in the foreseeable future in our plan, we have been very opportunistic with regards to buybacks again the MD&A.

Issued earlier today, the 10-Q will show you what we've been buying back our shares again, we will remain opportunistic buyers and we do have a remaining $1 2 billion remaining under our current $3 billion authorization.

Thanks, Bob to Wanda. Please have the next question. Please.

Thank you please stand by for our next question.

Our next question comes from the line of Tyler Van Buren with Cowen Your line is open.

Hi, guys. Good morning, congratulations on the great quarter.

I just pulled up the audra and extra might've been 5458, ash abstracts, and it'd be great to get a brief preview from you guys and what you need what you believe you ultimately need to show at the conference to be competitive relative to what other friction.

Yeah, I don't think we want to scoop ourselves.

The conference is coming up pretty soon Tyler.

But you know <unk>.

It has the potential of being a very important molecule. We recognize that there are some people ahead of us and we recognize that some of the most recent timelines have pushed back a little bit based on recent regulatory feedback.

The regulators have recently been focused on having phase III trials.

The ancillary enrolled at the time of submission.

Before they were granted accelerated approval, but we are confident in the profile of older next to Matt and as George says, there's also the future possibility.

Combinations with other things in our pipeline that could really even leapfrog.

Thanks, Glenn next question please to Wanda.

Thank you.

Please standby for our next question.

Our next question comes from the line of.

Solving Richard with Goldman Sachs. Your line is open.

Good morning, Thanks for taking my question on Eylea, what are you observing in the market between yourselves and Roche for the launch.

Sure happy to give more characterization you know as I mentioned, we see India continuing to perform extremely well, reaching all times high category share is 50% and now as well growth in the overall branded market, where we participate with other branded agents.

Leading British one thing I will mention just to give a bit more insight is that.

They are captured.

Growth coming primarily from Lucentis and also from Avastin and in fact, you know can you put the Roche portfolio together at the close of Eylea. Obviously was positive while there was a decline in overall market share for the Roche products combined.

Yeah.

Thank you Marianne next question to Linda.

Thank you please send off our next question.

Our next question comes from the line of Matthew Harrison with Morgan Stanley . Your line is open.

Great. Good morning, Thanks for taking the question George I was wondering if you could just comment on your outlook for the COPD study for <unk> and how you think about that market opportunity. Thanks.

I was silly COPD has been a very difficult disease for new therapies in biologics in particular.

We think that there is a category of patients with COPD, who have or are marked by more what we call th two type inflammation.

We think that as I said in my remarks that there was this unifying hypothesis that there are a lot of th.

Th two types of diseases that manifest in different ways.

We believe that this subset of patients with COPD may may be or fit into that category.

And.

And being able to benefit these patients in terms of either reducing their exacerbations and or improving their lung function would really make a difference to these patients and so we're anxiously awaiting the data and we're hopeful that we will have another set of patients where we are.

Might be able to demonstrate that depicts and could really make a difference.

Thanks, George to Wanda next question.

Thank you I'm on my far next question.

Our next question comes from the line of Tim Anderson with Wolfe Research. Your line is open.

Thank you so much.

Lilly will be launching <unk> in 'twenty, three and atopic derm and they update it looks comparable to 2%.

At least in this one indication pretty much a direct competitor.

Although not identical on mechanism.

No the derma space because it talks and the positioning is going to be that they can dose every month versus do pixel, which is every two weeks.

So I'm wondering if you have any strong views on that product or if you think that's going to be a total non-starter, which is pretty much the consensus view. Thank you.

It made me married can comment on it but look there's room for competitors in this market.

In this market where.

Where.

We're really modestly penetrated in.

The opportunity I don't think that the profile that you say is actually gonna be so far as we've seen it so far but all of that similar we have the earliest from infancy already to adulthood. That's a big deal. Okay. In addition, the fact that many of these people have other comorbidities.

Whether it be asthma or nasal polyps for example, and they can get a if they do have comorbidities or single drug can treat both is very big.

Differentiate us.

So I think when you are the market leader when you were so far ahead.

When you have really a differentiated profile.

You have an advantage obviously Lilly is a fine company.

Know, what they're doing but as I said, there's room frequently when a new good drugs come to market. There is a growth of the market.

But we're not going after a fixed number of patients were actually growing those patients Marion I don't know if you want to.

No I would just add that on most of the key opinion leaders that we speak to recognize that the dual mechanism of action the anti IL four coupled with anti IL 13, as Jerry is very important. So it's certainly efficacy shouldn't be assumed theres lots of reinforcement on the incredible efficacy for.

Ah patients with moderate to severe disease, and obviously real world experience is compelling.

Administration with the Texan is really quite straightforward.

<unk> administration.

We actually see there the occupation of parent involvement has been very helpful. In establishing copaxone, but that's certainly as Glenn mentioned, expanding the education and category to bring more atopic dermatitis patients into the treatment continuum, that's very positive for patients and certainly hard to pixel.

Not to pile on but since <unk> just to add onto what Len was saying I mean, the fact that the IL 13.

Failed.

These other important th two inflammation driven diseases like asthma, and like COPD and others right now really does suggest that they are not fully addressing the th two inflammation.

Both in any one particular disease, but also as Len said so many of these individuals'. If you just look at our label or any label that describes these diseases. They suffer from other allergic comorbidities and so I.

Obviously, you can make such a difference for a patient where one drug can treat a systemic disease as opposed to treating the disease only in one of the many compartments, where it manifests itself. I think this is the way I think medicine in the field should be moving this is a systemic disease.

Where th two inflammation is probably ramping in many compartments in the body.

Don't only want to treat it in one compartment you wanted to treat the entire body and that's what we've been showing systematically by going one disease. After another with to fixing it works in every compartment and it broadly attacks.

The underlying inflammation, that's related and causative and all of these diseases.

Okay. Thank you for that response to Wanda can we go to the next question.

Thank you please standby for our next question.

Our next question comes from the line of Mohit Bansal with Wells Fargo. Your line is open.

Great. Thanks for taking my question and congrats on the progress.

If I could probe a little bit further on the comments you made about the growth of anti VEGF market. You said, it's about 4% year over year seems like bit of a slowdown from what the high growth. We have seen could you elaborate further do you see.

One quarter or do you see any underlying trend there and is it because people have a hydro to be soft with Hulu, which is stepping down if you could help us understand that thank you.

I think it's very difficult to extrapolate one quarter, certainly I did mentioned that there'd been a sequential decline of about 2% from the second quarter into the third quarter in the overall anti VEGF category.

It's really difficult to extrapolate from that the numbers you shared on overall.

Here growth of category at about 4%, we recognize as well I think we'll have to see as that it took more time goes by but it's really difficult to draw conclusions on what may or may not have occurred in one quarter period.

Theres still quite a bit of room there.

Quite a bit of room of growth in the diabetic eye disease area, where.

We always thought we still see a decent growth that nat.

In that category.

Thank you.

Thank you. Thank you learn in Marion and Mohit next question please to Wanda.

Thank you please standby for our next question.

Our next question comes from Christopher Raymond with Piper Sandler Your line is open.

Hey, Thanks, just another question maybe on the VEGF market in an Eylea specifically.

So in our checks we get a sense if theres some docs, who believed that provides what confers differentiated efficacy.

But on the other hand, there is still a sizable amount of docs, who have yet to see a patients for follow up after the first dose.

Curious if in the field, you're seeing a difference in perception.

<unk> of our buyers know by time of experience that is any discernible change your perception that the more piece your follow up thanks.

And I think it's probably best set up ready to answer questions on you know what they're hearing about us I'll just share at this point I haven't heard characterization of that Easter is still at a low level in fact quite modest.

I can characterize Dan Lee of performance as they did in terms of market leadership and the growth we see in our business in terms of market share and other parameters.

And that is across indications and Eos.

Certainly substantially creating yeah as leader in the anti VEGF category.

Obviously, we're very enthusiastic as well as the retina community, probably even more important about the possibilities and potential of a flipper set eight milligram if approved in the future.

Thank you Marion next question please.

Please standby for our next question.

Our next question comes from the line of Colin Bristow with UBS. Your line is open.

Hey, good morning, and congrats on the quarter.

So on IL 23, we're starting to see some formally update so I was wondering could you just speak to how you see the market share evolving over the course of 'twenty three in light of the business and then obviously Biosimilars and then just as we think about high dose eylea in the back half of the year anything you can say intensive anticipated opex change.

Thank you.

So as a start we don't you know predict future market share performance, So I'm gonna stay away from specifics in that area.

Certainly not only this quarter, but over several quarters, we've been able to demonstrate continuing strong performance with eylea.

And she said she has a category leader and certainly we'll continue to work on that and you know as as agents have entered the market our competitors readiness abilities have been very strong, but most important frankly, it's the profile of Eylea M. D. The clinical attributes the safety of the product the breadth of indications.

Ease of access for physicians and patients, but like going forward certainly will be very much prepared to launch a flipper set eight milligram.

Now as we get into that launch potentially with an FDA approval, we'll be able to give more characterization, but as George and Len described today the profile, we see with a flipper set eight milligram and opinion leaders in the retina community you know confirm that this profile potentially has all the ingredients to become standard of care and certainly.

That's what we'll work on all the benefits of vision, coupled with safety and now this potential.

Cancel durability it hasn't been seen before in the category.

Yeah.

Colin it's Bob with regards to Opex, you know I mean Mary.

And I will do what we always do on the brands will look at what totally makes sense I mean, as you know it's kind of a defined number of retinal docs. So it's not as if we're going into a tremendously new area that creates a lot of new touch points on it.

And on top of that you know of Marion's team right now is a very tight functioning sales rep team I'm.

On the top of their game. So again, we don't expect some gigantic pivots on in this area, but again, we will make sure that we fund this appropriately and that it is.

The commercial side of it is going to match, how well the clinical data is going to stand up on it. Thanks.

Thank you. Your next question next question please.

Thank you please standby for our next question.

Our next question comes from the line of Brian Abrams with RBC. Your line is open.

Hey, good morning, Thanks for taking my question and congrats on the continued execution and innovation.

On the prostate by specific now that you've had more time with the evolving data any views on predictors of response or durability, there and I'm curious how good learnings might shape your latest thoughts on threading the therapeutic window, both for the PSM as you accelerate the trial enrollment as well as your other co stimulatory bi specifics. Thanks.

Yeah.

I think that.

Our data actually shows that.

With the remarkable response rates, we saw especially going to the higher doses that.

It's not as if you have to look hard to find biomarkers.

Our response remember just to remind you that at the highest dose three out of the four patients had very profound responses.

So response.

Predictors are not necessarily the issue, but you also point to the question about therapeutic window, certainly we are seeing auto immune related side effects.

Associated with these responses and so we are working hard now we're actually.

Celebrate enrollment in this program, we're trying to understand more of the relationship between the responders.

And having these otomi side effects I mean, one.

Very.

A positive perspective is we don't see these serious autoimmune side effects in people, who don't see responses. So it's the people who benefit who do get the autoimmune side effects. These are obviously, coupled it's because I think the drug is doing what we intended to do I think this is Sam.

The most exciting data in the history of immuno therapy that you can take what people have historically called a cold tumor that has almost no responses to immunotherapies PD, one therapy and get these incredibly high rates of very deep.

And so far durable responses.

And we will continue to work on.

Improving the therapeutic window in terms of the Bispecific program more broadly and I want to harken back lend lend sort of answered the previous question about CD 20, MB see me, but I do want to amplify.

On some of his comments, which is.

We think that there are indeed, a very small number of buy specs in the CD 20 space in the beef CMA space, which are actually looking quite competitive with each other including ours. The emerging data suggests the efficacy and safety profiles of these agents will.

We will be competitive with each other you will see our updated data were presented at ash.

But I think what's emerging is that these small numbers of competitors will exist in this field I think that there's going to be room for these there's there's actually a lot of patients in these late stage settings, who need treatment. So I think that there's going to be room for these small numbers of competitors there, but the future is going to be about moving.

Into earlier lines of therapy, and there is gonna be subtleties, there about how one executes designs. Those studies the co therapies more standard co therapies that are used there and so there's going to be a lot of actually art to how one moves these agents into the earlier lines of therapies, but.

The other very important thing is in addition to moving into earlier lines of therapy with these more standard combination, whereas I said, there's going to be a lot of art to doing those studies is going to be other novel combos and as we just talked about with the <unk> 20th coasting bi specifics that we've now shown that.

We're leading the field with.

In prostate cancer, we have very similar type agents now that we're going to be combining with our CD 20, bispecific in lymphoma, and with our be CMA bispecific in myeloma, and we think that these are going to really have the opportunity to continue to change.

The game and change the practice of medicine for these patients. So so it's about taking agents that R&D is going to be competitive and quite competitive with each other in these late stage settings, where I think they're all going to be making important contributions to the treatment of these patients, but then moving in.

Barry.

Uh Huh artful ways to these earlier lines of therapy and using them there.

Theres also going to be room, but there's always going to be room for differentiation as well as the future were making these combos with all of these exciting opportunities we have in our portfolio can really take them.

The utilization of these agents in the treatment for these patients and these Kansas to a whole another level as we believe we're already showing that we're doing in prostate cancer.

George I mean, there was one question about Biomarkers and prostate cancer, maybe you might just comment on how quickly you can use Psa.

The study after the paperwork exposed to both agents.

Right.

And in some of the data we've already shown and.

And we will continue to show me.

Many of our patients have remarkably high PSA level, because they have very high burden of disease as we all know depending on the assay in the labs and so forth normal PSA levels are in the single low single digits.

Now maybe one to four is considered the highest levels, we have patients who entered into our study with PSA is in the hundreds 500 600 and so forth.

And we.

We saw with this combination treatment as soon as you put the combination onboard.

Essentially at the next time point that we measured within three weeks or so we saw a dramatic drops of on the order of 99% reduction in the PSC and these are really astounding results and now we're we've continued to follow up patients over time, we've seen that for example, bone lesions have entirely normalizing.

So forth. So the effects are incredibly rapid as reflected in the PSA.

And.

To the point about predicting which patients respond it doesn't matter, whether you had patients who had relatively low burden as measured by PSA where their PSA was measured in the in let's say 40 to 50 range or whether you had incredibly high PSA in the five to 600 range.

Those patients seem to similarly respond in terms of very dramatic very profound drops in the PSA within weeks of starting therapy.

And as we've continued to follow these patients incredibly durable responses. Our first patient has now been out for more than a year.

They're immune side effects have resolved, whereas their complete remission has remained completely intact and as I said not only.

Clearly normalize the PSA levels, but the bone lesions and so forth have all normalize at least as measured by bone scans and so forth. So this is really has the potential to be so game changing for these late stage patients who really have at this point no other real recourse.

Thank you Len and George.

I think we have time for one more question.

The Wanda.

Thank you please standby for our final question.

Our final question comes from the line of.

Gould with Barclays. Your line is open.

Good morning, Thanks for taking.

Squeezing me in and taking the time, maybe just to come back to you for Maryann just how we should think about your expectations for the timeline to receive a J code for high dose Eylea.

Next year.

Seen in the past pretty very timeline here in terms of like jumping over you've got there is trend right almost immediately Roche clearly had a more paced process and I guess more to the point should our expectation be thats more of a like a January one 2024 type of event towards the potential for J code maybe in the later part 23. Thank you.

Alright, Thank you for the question and.

Certainly well stay very close on this and.

Obviously, the important says maybe L. A new J code.

Is important.

In terms of timing I would need a crystal ball.

Certainly would share with you will be working very closely with the departure of organizations and officials.

It's too early to give anything definitive on expectation for J code tiny yeah.

In my own perspective on a slightly different is that I'm not convinced in this particular setting.

J code or like the angle.

Like Youre going to see these dramatic changes and uptake.

A J code.

Well thank you.

I think that's all we have time for today. Thank you everyone for joining the call as always the investor relation is standing by for any follow up questions. You may have have a great day everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Q3 2022 Regeneron Pharmaceuticals Inc Earnings Call

Request a DemoDemo

REGN

Regeneron Pharmaceuticals

Earnings