Regeneron Pharmaceuticals Q3 2022 Earnings Call Transcript

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Provided by Quartr
November 3, 2022

There are 12 speakers on the call.

Operator

Hello, and welcome to Regeneron Pharmaceuticals Third Quarter 2022 Earnings Conference Call. My name is Towanda, and I will be your operator for today's call. Call. Please note that this conference is being recorded. I would now like to turn the call over to Ryan Crowe, Vice President, Investor Relations.

Operator

You may begin.

Speaker 1

Thank you, Towanda. Good morning, good afternoon and good evening to everyone listening around the globe. Call. Thank you for your interest in Regeneron, and welcome to our Q3 2022 earnings conference call. An archive of this webcast will be available on our Investor Relations website call.

Speaker 1

Joining me today are Doctor. Leonard Schleifer, Founder, President and Chief Executive Officer Doctor. George Yancopoulos, 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 call. After our prepared remarks, we will open the call for Q and A. I would also like to remind you that remarks made on call today include forward looking statements about Regeneron.

Speaker 1

Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecasting 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 call 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's filings with the United States Securities and Exchange Commission, including its Form 10 Q for the quarterly period ended September 30, 2022,

Speaker 2

call, which was filed with the

Speaker 1

SEC this morning. Regeneron does not undertake any obligation to update any forward looking statements whether as a result of new information, call. In addition, please note that GAAP and non GAAP measures will be discussed in today's call. 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, call, which can be accessed on our website.

Speaker 1

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

Speaker 2

With that, let me turn

Speaker 1

the call over to our President and Chief Executive Officer, Doctor. Len Schleifer. Len?

Speaker 3

Thank you, Ryan, and thank call. Regeneron's strong operational momentum continued in the 3rd quarter, call. Highlighted by important developments across our pipeline and outstanding commercial execution. Total revenues for the quarter increased by 11% call. Compared to last year when excluding contributions from our COVID antibody cocktail, with global net sales of Dupixent and Libtayo call.

Speaker 3

As well as U. S. Net sales of EYLEA once again reaching new all time quarterly highs and growing by double digits. Call. Before diving deeper into our commercial results, I'd like to review some of the recent progress we have made across our pipeline, call.

Speaker 3

Starting with the striking pivotal data that we reported in September for our investigation of aflibercept 8 milligrams, call. Which we believe could ultimately transform the treatment landscape for patients. With nearly 90% of DME patients And 80% of wet AMD patients able to sustain 16 week maintenance dosing through 48 weeks of treatment, call. We believe oflipacet 8 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. Call.

Speaker 3

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, call. With many potential treatments failing either due to suboptimal visual outcomes or safety issues. A recently approved anti VEGF agent 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 1st year of treatment, supporting our view that aflibercept 8 milligrams Has the potential to become the next generation standard of care anti VEGF treatment assuming regulatory approval. We plan to submit the aflipaset 8 milligram pivotal data to the FDA under a single BLA at the end of this year call. And have decided to use a previously granted priority review voucher to expedite the FDA review process.

Speaker 3

Pre launch planning is already underway with the potential FDA approval by late August 2023. Call. In addition to the pivotal of Flibercept 8 milligram data, Regeneron continued to make notable progress in our immunology and oncology pipelines. Call. Starting with immunology.

Speaker 3

In September, we received FDA approval for Dupixent in prurigo nodularis, the 1st systemic therapy call. For this indication and the 5th disease for which Dupixent is now approved. So far this year, Dupixent has received 4 U. S. Or EU regulatory approvals, expanding the treatment eligible population by approximately 225 1,000 patients, including in 2 diseases that previously had no FDA approved systemic therapies.

Speaker 3

Call. In the first half of next year, we are looking forward to EU regulatory decisions for eosinophilic esophagitis, prurigo nodularis and atopic dermatitis in patients as young as 6 months. With these potential additional indications, Approximately 200,000 more patients with these type 2 inflammatory diseases could benefit from Dupixent's unmatched clinical profile. Call. Additionally, we expect pivotal data readouts for Dupixent in chronic inducible cold urticaria and chronic obstructive pulmonary disease in the first half of next year.

Speaker 3

Moving to oncology, where the depth and breadth of our pipeline has positioned Regeneron 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 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 monotherapy in neoadjuvant CSCC as well as Libtayo in combination with fianlimab, our LAG-three antibody call and first line metastatic melanoma. We also presented monotherapy data for our MUC16xCD3 bispecific In recurrent ovarian cancer, which has the potential to be combined with Libtayo as well as data for our met by met biperitopic bispecific in met altered non small cell lung cancer. I'd also note The early but very exciting results for our PSMAxCD28 co stimulatory bispecific call in combination with Libtayo, which showed promising anti tumor activity in patients with advanced metastatic castrate resistant prostate cancer.

Speaker 3

The patients enrolled in our study have a poor prognosis With an expected survival of 1 to 2 years depending upon their treatment history. Given prostate cancer Has been largely unresponsive to PD-one inhibition and immunotherapy in general, there is a clear need for new treatments. In 2020 alone, there were over 375,000 deaths globally call from prostate cancer and it was the 2nd leading cause of cancer death in American men. We continue to expand our costimulatory bispecific efforts in prostate cancer with an acceleration in enrollment in our first in unit study Since we reported our top line results in August, and we look forward to updating you on this program in the first half of next year. Call.

Speaker 3

Now turning to our commercial performance. In the 3rd quarter, EYLEA global net sales grew 8% at constant currency call to $2,400,000,000 In the U. S, EYLEA net sales were $1,630,000,000 up 11% year over year And outperforming the anti vegum category growth of only 4%. Despite recent branded and biosimilar entrants, EYLEA set a new all time high for anti veghem category share in the United States. Call.

Speaker 3

The patient continued to grow at a remarkable pace, bolstered by approvals in new diseases and younger patient populations in previously approved indications. Call. In the Q3, global net product sales were $2,300,000,000 up 45% at constant currency call. Compared to last year, reflecting growth across all indications and all geographies. Dupixent's differentiated clinical profile call.

Speaker 3

An ability to effectively treat more and more patients in both currently approved indications and potentially for additional type 2 inflammatory diseases call. Is expected to drive strong growth in the future. Libtayo total net sales grew 25% globally at constant currency $243,000,000 in the 3rd quarter, including 21% growth in United States, driven by non melanoma skin cancer indications and monotherapy non small cell lung cancer. At the start of the Q3, we acquired Global Rights to Libtayo from Sanofi With potential future combinations, including with chemotherapy in non small cell lung cancer, as well as other pipeline agents in development, call. We believe Libtayo is poised to become a more meaningful revenue contributor over time.

Speaker 3

We are Excited about the strong commercial performance for our core products, the compelling efficacy, safety and durability data that we reported for aflibercept 8 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, call, some of which George will discuss in a moment. In closing, our strategy continues to focus call. On investing in our internal R and D capabilities, while exploring potential collaborations that will enable us to fully realize the power of our science. Call.

Speaker 3

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.

Speaker 2

Thank you, Len. I'll start with ophthalmology. The positive pivotal results for aflibercept 8 milligram in the PULSAR and FOTON studies were recently presented at the American Academy of Ophthalmology Annual Meeting. Results of these trials in wet AMD and DME respectively demonstrated that a remarkably high percentage of patients We're able to be rapidly initiated into and then successfully maintained through week 48 on 12 16 week dosing intervals, call. While achieving vision gains that were non inferior to the current standard of care, EYLEA 2 milligram dosed every 8 weeks.

Speaker 2

Call. These results suggest that aflibercept 8 milligrams has the potential to become the new standard of care in these retinal diseases. Call. 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 push the limits far beyond what has been accomplished with any currently available anti VEGF therapies.

Speaker 2

Call. Rather than using response criteria to try to identify or slowly extend patients to longer dosing intervals, Our trials tested whether all patients could be randomly assigned and rapidly initiated on extended dosing intervals of aflibercept 8 milligram Without compromising visual improvement or safety. These aflibercept 8 milligram trials accomplished just that for the vast majority, call. While delivering a safety profile consistent with that of EYLEA. 89% of DME patients and 77% of wet AMD patients We're able to be rapidly initiated and maintained on a 16 week of Liberacept 8 milligram dosing regimen, while 93% of DME And 83% of wet AMD patients were able to be rapidly initiating maintained on at least a 12 week dosing interval, call.

Speaker 2

All while delivering efficacy similar to that of Eylea administered every 8 weeks. We believe these are truly unprecedented and potentially game changing results, which have not been achieved using any other anti VEGF agent. Call. Novus has speculated that our Pulsar and Photon results were due to our dose modification criteria and even tried to theoretically extrapolate call. That your agent could have somehow approached these results using our criteria.

Speaker 2

We put these speculative extrapolations into the category of wishful thinking. And based on our expert analysis of the data, We conclude it is all about the drug and not the trial design. Briefly moving on to Dupixent. Building on our recent approval in eosinophilic esophagitis in adults and adolescents, we are planning on submitting a supplementary BLA for eosinophilic esophagitis in 1 to 11 year old children in mid-twenty 23. Dupixent's ability to treat eosinophilic esophagitis highlights.

Speaker 2

How important it is that our IL-four and IL-thirteen blocker more completely targets the entire type 2 inflammatory cascade And not only eosinophils. As you heard Len mentioned, the FDA label was expanded yet again in the 3rd quarter As Dupixent became the 1st and only treatment indicated for prurigo nodularis, a debilitating chronic skin disease. This marks the 5th disease for which Dupixent is now approved. Our collective clinical data with Dupixent support a unifying molecular mechanism call. Underlying these related diseases from asthma to atopic dermatitis to nasal polyps to prurigo nagilaris to atinophentic esophagitis.

Speaker 2

In this unifying hypothesis, IL-four and IL-thirteen induced inflammation is driving all of these related diseases in different tissue compartments. Moving to Libtayo and oncology. Call. In the Q3, our 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 and then continue into 2023. The European Society of Medical oncology or ESMO Annual Meeting in September was truly a banner event for Regeneron with several notable oral presentations for assets in our oncology pipeline, call.

Speaker 2

Which I'd like to briefly summarize. Starting with the enlamab, our LAG-three antibody in combination with Libtayo. At ESMO, We shared data from 2 independent advanced melanoma expansion cohorts from our first in human study, which importantly Show consistent efficacy and safety between the 2 replicative cohorts. Beanlumab in combination with Libtayo demonstrated greater than 60% response rates in each cohort. A median PFS estimated to be 24 months across both cohorts And a median duration of response that had not yet been reached.

Speaker 2

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 CTLA-four combinations. While dual LAG-three and PD-one inhibition call. As previously shown promise in advanced melanoma, response rates greater than 45% with median PFS of more than a year call. Had not been previously reported. These initial results in melanoma suggest that the amlumab, Libtayo combination As a potentially best in class profile in this setting, we are enrolling our Phase 3 metastatic melanoma study, intend to initiate a Phase 3 adjuvant melanoma study later this year and have additional plans in other solid tumors where fiamirimab has the potential to be 1st in class.

Speaker 2

Call. In neoadjuvant cutaneous squamous cell carcinoma or CSCC, a Phase 2 study of Libtayo monotherapy has shown promising results Given prior to potentially curative surgery in patients with large tumors, Libtayo was able to deliver major pathological responses to 63% of patients prior surgery. This raises the possibility that Libtayo could decrease the burden of these major and potentially disfiguring surgeries For the many patients who require them each year. We are pleased that concurrent with the ESMO 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 potential inclusion in the NCCN guidelines.

Speaker 2

Call. Also at ESMO, we presented initial clinical data for uvamatinib, our MUC16xCD3 bispecific developed for advanced ovarian cancer, Our first clinical data for a CD3 bispecific in a solid tumor. In a heavily pretreated ovarian cancer population, we observed durable responses To this MUC16xCD3 monotherapy. In a patient subset whose tumors overexpressed MUC16, response rates were as high as 31%. Most of the treatment emergent adverse events occurred with the initial step up dosing.

Speaker 2

Ubematumumab is being developed as a monotherapy as well as in combination with Libtayo as well as in combination with our MUC16 costin bispecific. We are looking forward to more data across these programs in 2023. In our ESMO investor presentation, call. We shared more detailed data for our PSMA by CD28 costin bispecific in combination with Libtayo, Representing the first efficacy and safety data for this new class of bispecifics, which we had initially top lined and discussed at our 2nd 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 twenty twenty three.

Speaker 2

Regarding our hemonc pipeline, we are looking forward to data from otrinex demand, our CD20xCD bispecific call. As well as limboceltamab, our BCMAxC3 bispecific at the American Society of Hematology or ASH Annual Meeting in December. Call. For rotraneximab, we will present pivotal Phase 2 data for both follicular lymphoma and diffuse large B cell lymphoma in 2 separate oral presentations. Upon discussions with the FDA, we are now targeting a second half twenty twenty three regulatory filing for this program.

Speaker 2

We hope to initiate combination studies with an appropriate CD28 costin bispecific in the near future. For limvacelitimab, our BCMAxCE3 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 our potentially pivotal Phase 2 study. As I mentioned earlier, data from this study will be updated at ASH. As with our tureximab, we are planning on initiating combination studies for nimvoseltamab with coast inventory bispecifics in the near future. Call.

Speaker 2

We believe existing standard of care therapies leave significant room for improvement in these difficult to treat settings and we have been encouraged by the interim efficacy and safety data We have generated to date for both odranexamab and limvoseltamab. Finally, at ESMO, we also shared initial data for our met by met bispecific antibody in met altered non small cell lung cancer. Responses were enriched in 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.

Speaker 2

In summary for oncology, Our rich combinatorial pipeline is delivering competitive data and with our full ownership of Libtayo, we're excited about the potential to advance standard of care in oncology call with our portfolio approach. Concluding with the Regeneron Genetics Medicines efforts, where we continue to progress our pipeline and discovery engine. Call. In September, we and Alnylam reported promising data from our ongoing Phase 1 study of Alnylam HSD call. In non alcoholic steatohepatitis or NASH, we are planning on initiating a Phase 2 study shortly, which is just one part of our multipronged approach exploring multiple genetically validated targets for NASH.

Speaker 2

Also in September, we and Intelie announced initial data from the cardiomyopathy call. Our ongoing Phase 1 study of NTLA-two thousand and one, an investigational CRISPR based therapy for the treatment of transthyretin amyloidosis, which showed deep and sustained mean serum TTR reductions of over 90% It was generally well tolerated. Finally, in October, our collaborators at Decibel Therapeutics announced FDA clearance call. For an NDA application for DB OTO, our first virally delivered gene therapy product candidate designed to provide hearing to individuals risodoferrin related hearing loss. This IND provides clearance to initiate a pediatric Phase onetwo clinical trial call in the United States.

Speaker 2

With that, I will turn it over to Mary

Speaker 4

Anne. Thank you, George. Our 3rd quarter performance reflects strength and growth across our commercial portfolio. We continue to extend our leadership position in additional therapeutic categories call as part of our commitment to deliver life changing medicines to patients in need. With Dupixent's approval in Proganagelaris, Libtayo's anticipated approval in combination with chemotherapy in first line advanced non small cell lung cancer call.

Speaker 4

And recent data demonstrating the compelling profile of aflibercept 8 milligram, Regeneron's commercial business is poised to deliver long term growth. Call. Starting with Eirya, which reached $2,400,000,000 in global net sales for the 3rd quarter. This represents call, an 8% increase on a constant currency basis, a remarkable achievement for a brand that launched 11 years ago. Call.

Speaker 4

In the U. S, EYLEA net sales grew 11% year over year to $1,630,000,000 to again achieve over 1,000,000 injections in the quarter. Call. Despite the overall 2% sequential category decline in volume from the 2nd to Q3 of 2022, EYLEA continued to grow across all indications, gaining share from both branded and unbranded agents. In fact, EYLEA reached all time highs in category share of approximately 50% with a commanding 75% share in the branded category.

Speaker 4

We continue to strengthen and extend EYLEA's leadership position in the anti VEGF category. As we recently announced, the FDA has granted pediatric exclusivity for EYLEA, call, thereby extending the period of EYLEA U. S. Market exclusivity by an additional 6 months through May 17, 2024. Call.

Speaker 4

Since announcing positive Phase 3 results earlier this year, there's been widespread excitement in the retina community about the aflibercept 8 milligram data set and offlibercept 8 milligram's potential to become the future standard of KR if approved. Next to Libtayo, call. Total global product sales were $143,000,000 growing 25% on a constant currency basis. In the U. S, net sales grew 21% to $95,000,000 call.

Speaker 4

Based on growth in our lung and non melanoma skin indications, we see particular opportunity for growth in lung cancer over time. Call. In monotherapy, there are already steady increases in prescribers and total utilization. We're launch ready for the potential chemotherapy combination approval, call, which significantly expands the patient opportunity. And finally to Dupixent, 3rd quarter global net sales were $2,300,000,000 call, up 45% on a constant currency basis.

Speaker 4

In the U. S, net sales grew 45% to $1,820,000,000 call, driven by robust demand across atopic dermatitis, asthma and nasal polyps. Growth was also driven by a rapid launch trajectory across recent indications, including isosinophilic esophagitis and pediatric atopic dermatitis, where Dupixent is the only biologic

Speaker 5

call to be approved from infancy through adulthood.

Speaker 4

Starting with dermatology and atopic dermatitis, Dupixent is the leading first line systemic therapy with strong uptake across the spectrum of moderate to severe disease and across age groups. The ongoing launch in children as young as 6 months is progressing very well, call, providing relief to children and their families as well as reinforcing the safety of Dupixent for all age groups. Call. We have also expanded Dupixent's leadership in dermatology following its approval in Praga Nogelaris. Dupixent is the only FDA approved medicine for this chronic debilitating skin disease that affects approximately 75,000 adults in the U.

Speaker 4

S. Early launch indicators are positive with patients already being initiated on therapy. Dupixent also continued to perform well in the highly competitive asthma market with steady growth in prescriptions and new patient starts as well as in nasal polyps. Early launch performance in the Symphog esophagitis has been very strong call. With broad adoption from both gastroenterologists and allergists, the medical community has embraced Dupixent as patients previously had very limited options.

Speaker 4

Dupixent is the only medicine indicated to treat acyenophilic esophagitis and is the only treatment shown to address the underlying disease causes, call. Resulting in unprecedented symptom relief. There are approximately 50,000 adults and adolescent patients in the U. S. Call, and we continue to advance our clinical efforts in younger patients where substantial unmet need remains.

Speaker 4

Outside the U. S. Dupixent, call. Net sales were $506,000,000 growing 44% on a constant currency basis. There is rapid uptake across approved indications, call, and we continue to execute on recent launches and expand into new geographies.

Speaker 4

As part of this, Regeneron's increased presence in key international markets supports efforts to bring Dupixent to even more patients. In conclusion, call. Our Q3 performance demonstrates strength and growth across our commercial portfolio. We are successfully executing on initiatives call. We deliver life changing medicines to patients and advancing strategies to maximize new and upcoming launches.

Speaker 4

Our commercial portfolio is positioned well call to drive long term and sustainable growth. Now I'll turn the call to Bob.

Speaker 6

Thank you, Marion. My comments call. On Regeneron's financial results and outlook will be on a non GAAP basis unless otherwise noted. Regeneron performed well in the Q3 with growth call 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-nineteen antibody cocktail, 3rd quarter total revenues increased 11% year over year to 2,900,000,000 call.

Speaker 6

Demonstrating continued growth momentum from our core business and reflecting the favorable impact of the Libtayo transaction. Q3 total diluted net income per share was $11.14 on net income of 1,300,000,000 call. Beginning with collaboration revenue and starting with Bayer. 3rd quarter 2022 ex U. S.

Speaker 6

EYLEA net product sales were 817,000,000 call. Up 4% on a constant currency basis versus Q3 of 2021. Total Bayer collaboration revenue was $333,000,000 of which $315,000,000 related to our share of Eylea net profits outside the U. S. Total Sanofi collaboration revenue was $711,000,000 in the Q3 of 2022 and grew 22% from the prior year driven by Dupixent.

Speaker 6

Call. Recall that in connection with the Libtayo transaction, we increased the repayment of our antibody collaboration development balance call from 10% to 20% of antibody collaboration profits. A portion of this step up is recorded as a reduction to antibody collaboration revenues, while another portion is recorded as R and D expense, given Regeneron is now recording its call. Full 50% share of antibody collaboration R and D expense as incurred. Previously Regeneron had only recognized a partial share of its antibody collaboration R and D expenses has incurred with the remaining share of expenses added to the antibody development balance.

Speaker 6

Also, call. As we highlighted last quarter in accordance with the agreement, we recorded a one time development balance repayment of 57,000,000 As an incremental reduction to Sanofi collaboration revenue in the Q3 of 2022. We have posted to our website supporting materials to further explain the accounting associated with this and other elements of the Libtayo transaction. Call. Moving now to our operating expenses.

Speaker 6

R and D increased 38% year over year to $817,000,000 call. Partially driven by the impact of the Libtayo transaction, which affects R and D in 2 ways. First, Regeneron now records all R and D expense for Libtayo, call. Which was previously shared equally with Sanofi. 2nd, as I mentioned earlier, Regeneron now records our full 50% share of antibody collaboration spend call for Dupixent and ittepacumab.

Speaker 6

SG and A expense increased 20% year over year to $467,000,000 call. Primarily driven due to incremental costs related to assuming global rights to Libtayo. Cost of goods sold in the Q3 was 109,000,000 And product gross margin in the quarter increased to 94% as compared to 90.2% in the prior year. Call. The more favorable gross margin was driven by the non recurrence of REGEN COVE sales in the current period in the removal of the payment to Sanofi call for their share of U.

Speaker 6

S. Libtayo gross margin. Finally, the Q3 2022 effective tax rate was 12.1 percent compared to 10.8% in the prior year. Shifting now to cash flow and the balance sheet. Call.

Speaker 6

Year to date in 2022, Regeneron has generated $2,900,000,000 in free cash flow and ended the Q3 of 2022 with cash and marketable securities Less debt of approximately $10,300,000,000 We remain focused on leveraging our strong financial position to deliver long term value for shareholders. Over the 1st 9 months of 2022, we have deployed in excess of $2,800,000,000 in capital. We have executed approximately $1,200,000,000 in business development initiatives, including the $900,000,000 acquisition of Libtayo Rights. Call. Additionally, we have repurchased over $1,600,000,000 of our shares, including over $900,000,000 in the 3rd quarter alone.

Speaker 6

Call. As of September 30, we had approximately $1,200,000,000 remaining on our current share repurchase authorization and we remain opportunistic buyers. Call. 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.

Speaker 3

In addition to these changes, call.

Speaker 6

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 and D investment to grow in 2023 comparable to or slightly above the 9 month year to date growth rate reported earlier today. The incremental R and D investment in 2023 will be driven by advancing our immuno oncology, hematology, Immunology and Genetics Medicine pipeline as well as the continued expansion of our R and D organization. Call.

Speaker 6

In addition, 2023 will be the 1st full year reflecting the impact of the Libtayo transaction, where we record 100 presentation.

Speaker 1

We will

Speaker 6

now begin the presentation of

Speaker 7

the global R and D spend for Libtayo and our

Speaker 6

full 50% share of the Sanofi antibody collaboration R and D spend as incurred. Call. For SG and A in 2023, we currently project growth in the mid teens versus 2022, given we'll be recording a full year of global Libtayo expenses call. Along with targeted investments in the build out of our international infrastructure. Finally, for other operating income and expense in the Q3 of 2022, call.

Speaker 6

We recognized the remaining $44,000,000 of deferred income related to previously received upfront payments and development milestones call. For vosinumab as a result of the program's discontinuation, we do not currently expect any material other operating income or conference in the Q4 of 2022, in 2023 and beyond, absent any new transactions. Call. In conclusion, Regeneron has performed exceptionally well in the 1st 9 months of 2022 and our strong financial position enables continued investment call to drive long term growth. With that, I will pass the call back to Ryan.

Speaker 1

Thank you, Bob. Towanda, this concludes our prepared remarks. We'd now like to open the call for Q and A.

Operator

With a number of

Speaker 1

callers in the queue. I'd like to ensure we 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. Towanda, please open the call for Q and A.

Operator

On your telephone. Please stand by while we compile the Q and A roster. Our first question comes from the line of Evan Singerman with BMO. Your line is open.

Speaker 5

Hi, guys. Thank you so much for taking my question Congrats on the progress. So with nearly $13,000,000,000 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 or issuing a dividend?

Speaker 6

Evan, hi, good morning. It's Bob. Call. With regards to capital allocation, demonstrated today by our growth in R and D in the 2023 forward guidance, call. We are going to continue to invest 1st and foremost in the R and D pipeline that we have.

Speaker 6

We issued our 10 Q this morning. Within the MD and A, you'll see a plethora of trials that are currently ongoing. And as George mentioned in his script, we're very bullish with regards to what is in the pipeline. Now, call. Again, with regards to business development, it's not an end or an or, right.

Speaker 6

As you saw and what we've done in the 1st 9 months of 2022, Where we do think there are opportunities and where we do think we can do collaborations where 1 plus 1 is 3, then we're absolutely going to Take that opportunity and I think CheckMate was a good example of that. And I would expect that you'd see more of that. With regards to your question on dividends, it's never and never. Obviously, 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.

Speaker 6

We have been very opportunistic with regards to buybacks. Again, the MD and A Issued earlier today, the 10 Q will show you what we've been buying back our shares. Again, we'll remain opportunistic buyers and we do have a remaining $1,200,000,000 remaining under our current $3,000,000,000 authorization. Thanks, Bob. Towanda, please have the next question on, please.

Operator

Call. Thank you. Please stand by for our next question. Call. Our next question comes from the line of Tyler Van Buren with Cowen.

Operator

Your line is open.

Speaker 3

Call. Hi, guys. Good morning. Congratulations on the great quarter. So I just pulled up the odraniximab and 5,458 ASH abstracts call.

Speaker 3

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 others have shown. Yes, I don't think we want to stoop ourselves So given that the conference is coming up pretty soon, Tyler. But ogeneximab has the potential Of being a very important molecule. We recognize that there's 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 substantially enrolled at the time of submission before they'll grant accelerated approval. But we are confident in the profile of odenxtimab.

Speaker 3

And as George says, there's also the future possibility of combinations with other things in our pipeline that could really even lead for us.

Speaker 1

Thanks, Lynn. Next question please Towanda.

Operator

Call. Thank you. Please standby for our next question. Call. Our next question comes from the line of Salveen Richter with Goldman Sachs.

Operator

Your line is open. Call. Good morning. Thanks for taking my question. On EYLEA, what are you observing in the market between yourselves and Roche for the Bemisinol launch?

Speaker 4

So happy to give more characterization. As I mentioned, we see EYLEA continuing to perform extremely well, call. 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, including Roche. One thing I will mention just to give a bit more insight is that EYLEA captured growth coming primarily from Lucentis and also from Avastin. And in fact, If you put the Roche portfolio together, the growth of EYLEA obviously was positive, while there was a decline in overall market share for the Roche products combined.

Speaker 1

Thank you, Mary Anne. Next question Towanda.

Operator

Thank you. Please standby for our next question. Question with Morgan Stanley. Your line is open.

Speaker 5

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

Speaker 5

Thanks.

Speaker 2

Obviously COPD has been a very difficult disease for new therapies and biologics in particular. We think that there's a category of patients with COPD who have or are marked by more what we call Th2 type inflammation. Call. We think that as I said in my remarks that there's this unifying hypothesis that there are a lot of Th2 types of diseases that manifest in different ways. We believe that this subset of patients with COPD may be call.

Speaker 2

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 might be able to demonstrate that Dupixent could really make a difference.

Speaker 1

Thanks, George. Towanda, next question.

Operator

Call. Thank you. One moment for our next question. Call. Our next question comes from the line of Tim Anderson with Wolfe Research.

Operator

Your line is open.

Speaker 7

Thank you so much. Lilly will be launching lebrikizumab in 23 in atopic derm, and they have data that looks comparable to Dupixent, at least in this one indication, pretty much a direct competitor, although not identical on mechanism. They know the derma space because of Taltz and the positioning is going to be that they can dose every month versus Dupixent, which is every 2 weeks. Call. 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.

Speaker 7

Thank you.

Speaker 3

Maybe Mary can comment on it. But look, there's room for competitors in this market. We're really modestly penetrated in the opportunity. I don't think that the profile that you say is actually Going to be so far as we've seen it so far, they're all that similar. We have the earliest from infancy Already to a delta, that's a big deal, okay.

Speaker 3

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 if they do have comorbidities, a single drug can treat both It's a very big differentiator. So I think when you're the market leader, when you're so far ahead, When you have really a differentiated profile, you have an advantage. Obviously, Lilly is a fine company. They know what they're doing. But as I said, there's room frequently when new good drugs come to market, There is a growth of the market.

Speaker 3

We're not going after a fixed number of patients, we're actually growing those patients. Marion, I don't know if you want call.

Speaker 4

Sure. I would just add that 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-thirteen is very, very important. So certainly efficacy shouldn't be assumed. There's also reinforcement on the incredible efficacy that's seen for patients Our next question is really quite straightforward. It's self administration and we actually see there the active patient or parent involvement has been very helpful in establishing Dupixent.

Speaker 4

But certainly as Len mentioned, expanding the education in category to bring more atopic dermatitis patients into the treatment continuum is very positive for patients and certainly for Dupixent.

Speaker 2

Not to pile on, but since just to call. Add on to what Len was saying. I mean the fact that the IL-thirteen

Speaker 5

have failed

Speaker 2

in these other important 2 inflammation driven diseases like asthma and like COPD and others right now really does suggest that they're not Fully addressing the Th2 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, obviously it 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 Th2 inflammation is probably rampant in many compartments in the body, you don't only want to treat it in one compartment, you want to treat the entire body. And that's what we've been showing systematically by going one disease after another with Dupixent.

Speaker 2

It works in every compartment and it broadly attacks the underlying inflammation That's related and causative in all of these diseases.

Speaker 1

Okay. Thank you for that response.

Speaker 7

Towanda, can we go to the next question?

Operator

Call. Thank you. Please stand by for our next question. Call. Our next question comes from the line of Mohit Bansal with Wells Fargo.

Operator

Your line is open.

Speaker 8

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

Speaker 8

Seems like bit of slowdown from what the high growth we have seen. Could you elaborate further? Do you see just 1 quarter, do you see any underlying trend there? Call. And is it because of the high growth we saw post COVID which is tapering down?

Speaker 8

You should help us understand that. Thank you.

Speaker 4

Call. I think it's very difficult to extrapolate 1 quarter. Certainly, I did mention that there had been a sequential decline of about 2% going from the Q2 into the Q3 in the overall anti Zedge's category. Call. And I think it's really difficult to extrapolate from that.

Speaker 4

The numbers you shared on overall year over year growth of category at about 4%, call. We recognize as well. I think we'll have to see as a bit more time goes by, but it's really difficult to draw conclusions on what may or may have occurred in a one quarter period.

Speaker 3

There's still quite a bit of room of growth in the diabetic eye diseases area, We still see a decent growth there in that category.

Speaker 9

Headfully. Thank you.

Speaker 1

Call. Thank you. Thank you, Lynn and Marion and Mohit. Next question please, Towanda.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Christopher Raymond with Piper Sandler. Your line is open.

Speaker 9

Call. Hey, thanks. Just another question, maybe on the VEGF market and EYLEA specifically. Call. So in our checks, we get a sense that there's some docs who believe that the Vipizmo confers differentiated efficacy.

Speaker 9

But on the other hand, there's still a sizable amount of docs who've yet to see a patient for follow-up after the first dose. So I'm just curious If in the field you're seeing a difference in perception of abysmal by time of experience, call. That is any discernible change in perception, the more patient of follow-up they've had? Thanks.

Speaker 4

Call. I think it's probably best that Roche answer questions on what they're hearing about use. I'll just share at this point, I haven't heard characterization of that. Call. This is still at a low level, in fact quite modest.

Speaker 4

I can characterize the EIMEA performance as I 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 certainly substantially creating EYEA call as leader in the anti VEGF category. And obviously, we're very enthusiastic as is the retina community, probably even more important about the possibilities and potential of afliprisev 8 milligram if approved in the future.

Speaker 1

Call. Thank you, Marion. Next question please.

Operator

Please stand by for our next question. Our next question comes from the line of Colin Bristol with UBS. Your line is open.

Speaker 10

Hey, good morning and congrats on the quarter. So on EYLEA in 2023, we're starting to see some formulary updates. So I I was wondering, could you just speak to how you see the market share evolving at the course of 2023 in light of Bismol and then obviously biosimilars? Call. And then just as we think about high dose EYLEA in the back half of the year, anything you can say in terms of anticipated OpEx changes?

Speaker 10

Thank you.

Speaker 4

Call. So as a start, we don't predict future market share performance. So I'm going to stay away from specifics in that area. Call. Certainly, not only this quarter, but over several quarters, we've been able to demonstrate continuing strong performance with EYLEA call as anti vegjet category leader and certainly we'll continue to work on that.

Speaker 4

And as agents have entered the market, our competitive readiness abilities have been very strong, but most important, frankly, it's the profile of EYLEA. The clinical attributes, the safety of the product, the breadth of indications, ease of access for physicians and patients. But going forward, certainly, we'll call. We will be very much prepared to launch a flippercept 8 milligram. And as we get into that launch potentially with an FDA approval, we'll be able to give more characterization.

Speaker 4

Call. But as George and Len described today, the profile we see with aflibercept 8 milligram and opinion leaders in the retina community call. You'll 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 couple of safety and now there's potential of substantial durability that hasn't been seen before in the category. Call.

Speaker 6

Collyn, it's Bob. With regards to OpEx, I mean, Marion and I will do what we always do on the brands. We'll look at what totally makes sense. Call. I mean, as you know, it's kind of a defined number of retinal docs.

Speaker 6

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, on Merriam's team right now is a very tight functioning sales rep team, on the top of their game. So again, we don't expect Some gigantic pivots 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.

Speaker 1

Thank you. Next question please.

Operator

Call. Thank you. Please stand by for our next question. Our next question comes from the line of Brian Abrams with RBC. Your line is open.

Speaker 5

Hey, good morning. Thanks for taking my question and congrats on the continued execution and innovation. Call. On the prostate bispecific, now that you've had more time with the evolving data, any views on predictors of response or durability there? And call.

Speaker 5

I'm curious how your learnings might shape your latest thoughts on threading the therapeutic window both for the PSMA as you accelerate the trial enrollment as well as your other co stimulatory bispecifics? Thanks. Call.

Speaker 2

Yes. I think that our data actually shows that With the remarkable response rates we saw, especially going to the higher doses that To remind you that at the highest dose, 3 out of the 4 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 autoimmune related side effects associated with these responses. And so we're working hard now.

Speaker 2

We're actually, we've accelerated enrollment in this program. We're trying to understand more the relationship between the responders and having these autoimmune side effects. I mean, one very positive perspective as we don't see these serious autoimmune side effects in people who don't see responses. So it's people who benefit, who do get the autoimmune side effects. These are obviously coupled.

Speaker 2

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 that you can take what people have historically called a cold tumor That has almost no responses to immunotherapy or to 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, Len sort of answered the previous question about CD20 But I do want to amplify on some of his comments, which is, we think that there are indeed a very small number of bispecs in the CD20 space and the BCMA space, which are actually looking call. Quite competitive with each other, including ours. The emerging data suggests the efficacy and safety profiles of these agents We'll be competitive with each other.

Speaker 2

You will see our updated data. We'll present it 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 actually a lot of patients in these late stage settings who need treatment.

Speaker 2

So I think that there's going to be room for these small numbers of competitors there. Call. But the future is going to be about moving into earlier lines of therapy and there's going to 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 In addition to moving into earlier lines of therapy with these more standard combinations, where as I said, there's going to be a lot of art to doing those studies, It's going to be the novel combos.

Speaker 2

And as we just talked about with the CD20 and costim bispecifics that we've now Show that we're leading the field with. In prostate cancer, we have very similar type agents now And we're going to be combining with our CD20 bispecific in lymphoma and with our BCMA 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 it's about taking agents that are indeed 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 very artful ways To these earlier lines of therapy and using them there, where I think there's also going to be room, but there's also going to be room for differentiation, As well as the future, we are making these combos with all of these exciting opportunities we have in our portfolio can really take The utilization of these agents and the treatment for these patients and these cancers to a whole another level, as we believe we're already showing that we're doing in prostate cancer.

Speaker 3

George, there was one question about biomarkers in prostate cancer. Maybe you might just comment on how quickly you can use PSA in our studies After people were exposed to both agents.

Speaker 2

Right. And in some of the data 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 and the labs and so forth, normal TSA levels are in the low single digits, Maybe 1 to 4 is considered the highest levels. We have patients who entered into our study with PSAs in the 100, 500, 600 and so forth. And we saw with this combination treatment.

Speaker 2

As soon as you put the combination on board, essentially at the next time point that we measured within 3 weeks or so, We saw dramatic drops of on the order of 99% reductions in the PSC. And these are really astounding results and now Where we've continued to follow-up patients over time, we've seen that, for example, bone lesions have entirely normalized 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 let's say 40 to 50 range or whether you had incredibly high PSAs in the 5 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.

Speaker 2

Their immune side effects have resolved, Whereas their complete remission has remained completely intact. And as I said, not only Completely normalized the PSA levels, but the bone lesions and so forth have all normalized at least as measured by bone scans and So this is really has the potential to be so game changing for these late stage patients who really have call. At this point, no other real recourse.

Speaker 1

Thank you, Len and George. I think we have time for one more question. Just Towanda.

Operator

Our final question comes from the line of Carter Gould with Barclays. Your line is open.

Speaker 11

Call. Good morning. Thanks for squeezing me in and taking the time. Maybe just to come back to for Marion, call. Just how we should think about your expectations for the time line to receive a J code for high dose EYLEA next year.

Speaker 11

We've seen in the past Pretty varied timelines here in terms of like, Bayou got there, it turned around almost immediately. Roche clearly had a more pace process. And call. I guess more to the point, should our expectation be that's more of like a January 1, 2024 type event or is the potential for a J code maybe in the later part of 2023? Thank you.

Speaker 4

Quarter. Thank you for the question. And certainly, we'll stay very close on this. And obviously, the importance of new BLA, new J code is important. In terms of timing, I would need a crystal ball.

Speaker 4

Certainly, we'd share with you, we'll be working very closely call. With the proper organizations and officials, but at this time it's too early to give anything definitive on expectation for J code timing.

Speaker 7

Yes. And this is Len. I mean, my

Speaker 3

own perspective on this slightly different is that I'm not convinced in this particular setting The J code is like the end all be all of like you're going to see these dramatic changes call. Okay.

Speaker 1

Call. I think that's all we have time for today. Thank you, everyone, for joining the call. As always, the investor really is standing by for any follow-up questions you may have. Call.

Speaker 1

Have a great day, everyone.

Operator

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

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Earnings Conference Call
Regeneron Pharmaceuticals Q3 2022
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