Q4 2021 Incyte Corp Earnings Call

Hello, and welcome to the insight fourth quarter and full year earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. Please press star zero on your telephone keypad. It's now my pleasure to turn the call over.

Speaker 1: Hello and welcome to the Insight fourth quarter and full year earnings.

Speaker 1: At this time, all participants are in a listen-only mode. A question and answer session will follow the form of...

Speaker 1: If anyone should require operator assistance, please press star zero on your telephone.

Speaker 1: Now my pleasure to turn the call over to Christine Cho, Head of Investor Relations. Please go ahead.

So Christine Cho head of Investor Relations. Please go ahead.

Speaker 2: Thank you, Kevin. Good morning and welcome to Insight's fourth quarter and full year 2021 earnings conference call and webcast. The slides presented today are available for download on the investor section of our web.

Thank you Kevin Good morning, and welcome to insights fourth quarter and full year 2021 earnings conference call and webcast.

Presenting today are available for download on the investors section of our website joining me on the call today are very very Steven and Christiana, who will deliver our prepared remarks, and gosh, who will join us for the Q&A.

Speaker 2: Joining me on the call today are Hervé, Barry, Steven, and Christiana, who will deliver our prepared remarks, and Dash, who will join us for the Q&A.

Speaker 2: Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements and are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our reports filed with the SEC. We will now begin the call with Hervé. Thank you, Christine.

Before we begin I'd like to remind you that some of the statements made during the call. Today are forward looking statements and are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our reports filed with the SEC. We will now begin the call with are they.

Thank you Christine and good morning, everyone.

Speaker 3: So we have another year of strong commercial performance with product and realty revenues growing 17% to reach 2.9 billion.

So that's cool so we had that and I think I'm not sure about four months with product and royalty revenues growing 17% reached $2 9 billion.

Speaker 3: Representing a K-GRA of 24% of all the past 5 years.

Representing a CAGR of 24% over the past five years.

Speaker 3: We have been able to maintain this level of growth through continued commercial execution for JAKA5, launches of new products and new indications across the US, Europe and Japan, and a rapidly growing, wired.

We have been able to maintain this level of growth through continued commercial execution. So on jakafi.

New product a new indication of course, the U S Europe and Japan.

And the rapidly growing royalty revenue stream.

Speaker 3: Check-as-five grew 10% for the footier and was up 15% in the fourth quarter.

But I guess, if I grew 10% for the food.

In the fourth quarter.

Speaker 3: Driven by the launch in steroid refractory chronic GVHD and robot, new patient growth in MF and

Driven by the launch in steroid refractory chronic gvhd and what about new patient growth in MF and PV.

Speaker 3: For the full year, our other hematology and oncology portfolios grew 40% year over year with contributions from new product launches including 69 million from Pemezie and 5 million from Minjoo Vee and our Royalty revenues grew 45% to 569 million for the full year.

For the full year.

It was only a matter of general quality portfolio grew 40% year over year with contributions from new product launches, including 69 million from Timothy Yeah.

5 million from mutual V and royalty revenue grew 45% to 500, rather than 69 million for the full year.

Speaker 3: What's important to note is that this growth does not get include meaningful contribution from recently approved products such as Minjouvi in Europe and the PLA in the EU.

What's important to note is that this growth does not yet include meaningful contribution from our recently approved products such as means Ruby in Europe and up their lines of U S.

Okay.

Speaker 3: On flight 5, as we look ahead to 2022, we have multiple opportunities for growth across our portfolio with our recently launched product. Observe in atopic dermatitis.

On slide five as we look ahead to 'twenty to 'twenty, two we have multiple opportunities for growth across our portfolio with a recently launched product observed in atopic dermatitis.

Speaker 3: VMAZIR in colon geogarcinoma, Monjuvi and Minjuvi in relapse or refractory DLBCL, and Zag Garn Stories

We met you in Colombia, I guess, you know my mantra.

Relapsed or refractory <unk>.

Jakafi in chronic gvhd.

Speaker 3: Later this year, we expect regulatory decisions in the US and in Europe for Roxalitin-Crem in vitiligo, a disease that affects millions of patients and for whom there is no approved treatment for repigmentation.

Later this year, we expect regulatory decisions in the U S and in Europe for Rux cream.

Cream in vitiligo, a disease that affects millions of patients for whom there is no approved treatment for a re pigmentation.

So I went back up products with Novartis drug. So do you think that is under review in Europe , and Japan for Gvhd I'm kept met the Navy's under review in Europe for non small cell lung cancer.

Speaker 3: For our work. personner product with novaes road cityteen is under review. Europe and Japan for G V H, D and cap AIS under review. Europe for non small CE lankcan.

Speaker 3: Regulatory application were also submitted by Lili for baracitini in the US, Europe and Japan for aduppay chariot.

The regulatory application aware also submitted by <unk> for a box, it's really been the U S Europe , and Japan, Florida, Vishal, yet though.

Speaker 3: 2022 is a year full of important milestones where we will develop and expand our pipeline, deliver new data in key clinical programs, and continue driving uptake of our newly launched product and new indications.

2022 is a year full of important milestone, where we will develop and expand our pipeline did you bid on new data and clinical program and continue driving uptake of our newly launched products and new indications.

Speaker 3: Before handing the call over to Barry, I want to say a few words on the launch of Obserua and I were expanding footprint in their metallurgy.

Before handing the call over to Barry I want to say a few words on the launch of up to us and they were expanding footprints in dermatology.

Speaker 3: A few years ago we expanded our development capabilities into dormitology with the intention to bring ruxalutinib cream to market.

She also go we expanded our development capabilities into them at the end of June with the intention to bring rux cream to market.

Speaker 3: We were able to implement robust and successful development program for also using a cram in atopic dermatitis and PT LIGO. And of the row, became the first topical jacket inhibitor approved in atopic dermatitis in the US and has the potential to be the first FDA approved product for repigmentation in CT LIGO.

We were able to implement a robust and successful development program for rux cream in atopic dermatitis and vitiligo.

Zero I became the first topical JAK inhibitor are approved in atopic dermatitis in the U S and has the potential to be the first FDA approved product for pigmentation in vitiligo.

Speaker 3: As you can see on the right, we have seen expand our dermatology clinical development pipeline to include multiple products and indications.

As you can see on the right we have since expanded dermatology clinical development pipeline to include multiple products and indications.

Speaker 3: We also established a dedicated commercial organization in the US to support the launch of Opteroire, and these efforts have been translating into a very successful launch that...

We also established a dedicated commercial organization in the U S to support the launch of up there are and these are folks had been translating into a very successful launch this fall.

We expect our dermatology franchise to become an important growth driver for insight starting with ups, there, which we believe can reach one 5 billion in pig says you have to think that I think just in the U S alone.

Speaker 3: We expect our dermatology franchise to become an important gross driver for insight, starting with Obserar, which we believe can reach 1.5 billion in pixels in a repeat of 80s in the US.

Speaker 3: And to share more details on Obserua and Dracat5 performance and outlook, I'll note down the would you like to win?

And to share more details on up to runs that got price performance and outlook I'll turn the call over to Barry.

Speaker 4: Thank you, Irving. Good morning, everyone. We are very pleased with performance of Ocelora thus far, and we are making significant progress with the launch on multiple fronts.

Thank you everybody and good morning, everyone.

We're very pleased with performance of absolutely, thus far and we are making significant progress with the launch on multiple fronts.

Starting with the uptake of absolute aura in the left hand side is 867 data, which is number of units of absolute 60 Gram tubes that are wholesalers are shipping the pharmacies. These data tie closely to prescriptions dispensed given the low level of inventory retail pharmacies typically hold for specialty.

Speaker 4: Starting with the uptake of Opsilora. And the left hand side is 867 data, which is number of units of Opsilora, 60 gram tubes that are wholesalers are shipping the farmers.

Speaker 4: These data tie closely to prescriptions dispensed, given the low level of inventory retail pharmacies typically hold for specialty dermatology products.

Dermatology products.

Speaker 4: In a fourth quarter, since launching on October 11th, nearly 21,000 units have been shipped to pharmacies, and in the month of January , nearly 11,000 units have been shipped. As you can see, the demand for Opsilora in recent weeks continues to climb, and the trends are very encouraging.

In the fourth quarter since launching on October 11th nearly 21000 units have been shipped to pharmacies and in the month of January nearly 11000 units have been shipped as you can see the demand for absolute aura in recent weeks continues to climb and the trends are very encouraging.

Speaker 4: On the right hand side is Accuvia data showing new to brand share for Upsilon in our market basket, which includes duPixen, Eucrytha, Prothotic and Eladil and their generic.

On the right hand side is IQ via data showing new to brand share for absolutely right in our market basket, which includes depicts it you Chris a CRO topic, an ela deal and their generics.

Speaker 4: In the 16th week since launch, as shown on the chart, Upsilon is capturing over 10% of all new to brand prescriptions after steroids failure.

In the 16th week since launch as shown in the chart apps laurus, capturing over 10% of all new to brand prescriptions. After steroid failures not shown on this slide are the refills, which comprised 15% of the total Rx is as of the week ending January 28, the number of refills demonstrates the.

Speaker 4: Not shown on this slide are the refills, which comprise 15% of the total Rx's as of the week ending January 28th. The number of refills demonstrates the satisfaction that patients and physicians are experiencing and is a very positive indicator of the long-term potential of Opsalora.

<unk> that patients and physicians are experiencing and it is a very positive indicator at the long term potential of obsolete.

On slide nine.

Speaker 4: What further excites us about the launch is a very positive feedback we are receiving from physicians who are prescribing Opsilora, which is supported by the most recent survey conducted in the field.

With further excites us about the launches of very positive feedback, we're receiving from physicians, who are prescribing absolute Ora, which is supported by the most recent survey conducted in the field.

[noise] prescribers were asked how many atopic dermatitis patients they prescribed <unk> two for the first time in the past month. They were also asked how many new patients they expect to treat with apt to Laura and then next month results showed that there is an increased willingness to prescribe <unk> and physicians are highlighting the ethical.

Speaker 4: Prescribers were asked how many atopic dermatitis patients they prescribed Opsalora 2 for the first time in the past month. They were also asked how many new patients they expect to treat with Opsalora in the next month. Results showed that there is an increased willingness to prescribe Opsalora and physicians are highlighting the efficacy, specifically the rapid itch relief and skin clearance, as well as the safety in a topical formulation as the top reasons for prescribing.

Specifically, the rapid itch relief and skin clearance as well as the safety in a topical formulation at the top reasons for prescribing.

Speaker 4: There are millions of AD patients living with uncontrolled disease in the US, and there is enthusiasm from both physicians and patients to try a new, non-ceroidal, topical treatment with a novel mechanism of action with the expectation that patients will be able to find relief of their AD symptoms.

There are millions of patients living with uncontrolled disease in the U S and there is enthusiasm from both physicians and patients to try a new nonsteroidal topical treatment with a novel mechanism of action with the expectation that patients will be able to find relief out there a these symptoms.

Speaker 4: On a payer front, I'm happy to report that contract negotiations have been progressing well. We now have base rebate agreements signed with two of the three largest GPOs.

On the payer front I'm happy to report that contract negotiations have been progressing well, we now have base rebate agreements signed with two of the three largest keep he owes these agreements established utilization management criteria and discount rates.

Speaker 4: These agreements establish utilization management criteria and discount rates for approximately 55% of commercial lives covered under these two PBM.

We're approximately 55% of commercial lives covered under these two pbms.

For this non N D C block business Pbms and associated plans are now establishing policies to provide access to absolute Laura.

Speaker 4: For this non-NDC-blocked business, PBMs and associated plans are now establishing policies to provide access to Opsalora.

Speaker 4: For the other 45% of covered lives under these two PBMs, we are in active contract negotiations to remove the new-to-market, or NDC, block.

For the other 45% of covered lives under these two pbms, we are in active contract negotiations to removed and new to market or mtc blocks.

Speaker 4: For the third PBM, negotiations continue to advance.

The third P. B M negotiations continue to advance these are important steps towards gaining full coverage for <unk> for the millions of patients who whose prescription services are managed by these pbms.

Speaker 4: These are important steps towards gaining full coverage for Opsalor for the millions of patients whose prescription services are managed by these PBMs.

Turning to slide 11 in the fourth quarter, our patient support program covered the vast majority of prescriptions were recovered the full cost of ops Laura for many patients.

Speaker 4: Turning to slide 11, in the fourth quarter, our patient support program covered the vast majority of prescriptions where we covered the full cost of Opsilor for many patients.

Speaker 4: As the coverage for Opsilor improves, the utilization of this specific program will decrease and will lead to an improvement in gross finesse.

The coverage for obsolete or improves the utilization of this specific program will decrease and will lead to an improvement in gross to net.

Our co pay mitigation program will continue and allow patients to lower their out of pocket cost to as little as $10 in.

Speaker 4: Our copay mitigation program will continue and allow patients to lower their out-of-pocket costs to as little as $10.

Speaker 4: In summary, the strong launch of Opsilora has been driven by several factors. The product has a unique profile unmatched by any other topical therapy for atopic dermatitis.

In summary, the strong launch of Absolut has been driven by several factors.

<unk> has a unique profile unmatched by any other topical therapy for atopic dermatitis.

Speaker 4: And we are launching into a market where there are millions of patients living with uncontrolled disease.

And we are launching into a market, where there are millions of patients living with uncontrolled disease patients and physicians are reporting positive experience and are requesting retails and this cycle is fueling much of the momentum behind the launch of OXXO Lora, which is on track to be a significant growth driver for insight.

Speaker 4: Patients and physicians are reporting positive experience and are requesting refills, and this cycle is fueling much of the momentum behind the launch of Opsulaura, which is on track to be a significant growth driver for Insight.

Now turning to Jakafi in the fourth quarter Jakafi grew 15% year over year to $592 million patient demand continues to drive the uptake of Jakafi with robust new patient growth across all indications in gvhd patient growth was up 28% for the full year and up.

Speaker 4: Now, turning to jack-ify. In the fourth quarter, jack-up-I group 15% year-over-year to $592 million. Patient demand continues to drive the uptake of jack-ify with robust new patient growth across all indications.

Speaker 4: In GVHB, patient growth was up 28% for the full year, and up 39% in fourth quarter, benefiting from the launch in the chronic setting, and the transition of GVHB patients from our expanded access program to commercial products.

39% in fourth quarter benefiting from the launch in chronic in the chronic setting and then transition of gvhd patients from our expanded access program to commercial product.

Speaker 4: We expect growth of new patients to continue into 2022 and for the full year, net product revenues to be between $2.3 billion and $2.4 billion.

We expect growth of new patients to continue into 2022.

For the full year net product revenues to be between $2 3 billion and $2 $4 billion.

Speaker 4: This guidance range takes into account the newly launched indication in chronic TBHD and a continued recovery of new patients start.

This guidance range takes into account the newly launched indication in chronic gvhd and the continued recovery of new patient starts.

Speaker 4: And lastly, on Manjubi, Minjubi, and Pemezir.

And lastly on mine jewelry men's UV and payments here.

Speaker 4: Monsubi sales in Q4 were $24 million. We continue to make progress with penetration into key accounts and increasing uptake of Monsubi in the second line setting. Boalier guidance for 2022 of $110 to $135 million for net product sales as recorded by more doses takes into consideration a continuation of the momentum in Q4, new account penetration and impact from COVID.

<unk> sales in Q4 were $24 million, we continue to make progress with penetration into key accounts and increasing uptake of <unk> in the second line setting.

Full year guidance for 2020 to a $110 million to $135 million for net product sales as recorded by morphosis takes into consideration a continuation of the momentum in Q4, new account penetration and an impact from Covid.

Speaker 4: Minjubi, which was approved in Europe in August of last year and was launched in Germany. Net sales in the fourth quarter were four million dollars. While it is still very early, we are encouraged by the initial uptake and expect Minjubi to become a meaningful ghost contributor as we continue to gain reimbursement in other European countries.

<unk>, which was approved in Europe in August of last year and was launched in Germany net sales in the fourth quarter were $4 million. While it is still very early we are encouraged by the initial uptake and expect <unk> to become a meaningful growth contributor as we continue to gain reimbursement in other European.

Countries.

Speaker 4: Hemzier grew to $69 million in net sales in 2021, with $10 million coming from outside the U.S.

<unk> grew to $69 million in net sales in 2021 with 10 million coming from outside the U S.

Speaker 4: In the U.S., new patient starts continue to grow with the ration of therapy likely to drive performance. With that, I'll turn the call over to Steven.

In the U S. New patient starts continue to grow with duration of therapy likely to drive performance with that I'll turn the call over to Steven.

Thank you Barry and good morning, everyone.

In 2021, we made significant progress across our development pipeline with multiple clinical and regulatory achievements.

Speaker 5: In 2021 we made significant progress across our development pipeline with multiple clinical and regulatory achievements.

We announced four product approvals and include Jakafi in the United States for chronic graft versus host disease when juvie in Europe for diffuse large b cell lymphoma, <unk> in Europe , and Japan for Cholangiocarcinoma and most recently <unk> in United States for atopic dermatitis.

Speaker 5: We announced four product approvals that include Jackify in the United States for chronic graft-versus-host disease.

Speaker 5: Minjuvie in Europe for the Fuse-Large B.C.L. Pemizere in Europe and Japan for Kalandia-Costinoma and most recently, obsulara in the United States for a topic dermatitis.

Speaker 5: Further on the regulatory side, ruxilate and whipped cream is under review at both the FDA and EMA for vitiligo.

Further on the regulatory side <unk> cream is under review at both the FDA and EMA Hoover Lager.

Throughout the year, we delivered key clinical highlights as listed on the right which include positive phase III data for <unk> cream in vitiligo and the initiation of a phase III study evaluating <unk> in autoimmune hemolytic anemia, following positive phase II results.

Speaker 5: Throughout the year we delivered key clinical highlights as listed on the right, which include positive phase 3 data for Ruxilidin of Creamin Vidalago, and the initiation of a phase 3 study evaluating POSI-Classic in Orimune Hemolytic Anemia, following positive phase 2 results.

Speaker 5: We also signed a collaborative agreement with Syndax for axotilimab in chronic graft versus host.

We also signed a collaborative agreement with <unk> in chronic graft versus host disease, which granted us the right to develop <unk> as a monotherapy following treatment with jakafi or in combination with the JAK inhibitor earlier in the treatment paradigm.

Speaker 5: which granted us the right to develop axotilamab as a monotherapy following treatment with Jackify or in combination with the Jack inhibitor earlier in the treatment paradigm.

Speaker 5: And we shared data from our oral PD-L1 program, where we demonstrated for the first time ever clinical activity with an oral PD-L1 inhibitor.

And we share data from our oral PD Lone program, where we've demonstrated for the first time ever clinical activity with an oral PD lone inhibitor.

Moving to slide 16, as I mentioned the S. NDA for <unk> cream in Vitiligo was accepted for priority review by the U S. FDA with a <unk> action date of April 18th.

Speaker 5: Moving to slide 16, as I mentioned, the S&DA for Axel and the Cream in Vidaligo was accepted for priority review by the USFTA with a producer action date of April 18th.

<unk> represents another significant opportunity for our growing dermatology franchise.

Speaker 5: Little Aga represents another significant opportunity for growing dermatology friends.

Speaker 5: In the United States, there are currently 1.5 million people living with Vidaligo, and only 150 to 200,000 patients currently seek treatment due to a lack of effective treatment option.

In the United States. There are currently $1 5 million people living with vitiligo and only 150 to 200000 patients currently seek treatment due to a lack of effective treatment options.

Speaker 5: The quality of life for some patients with vitiligo can be poor, with 1 in 4 patients reporting depression and 1 in 7 reporting anxiety due to their disease.

The quality of life for some patients with vitiligo can be poor with one in four patients reporting depression, and $1 seven reporting anxiety due to their disease.

Many of it'll lag of patients experienced psychological social and physical impacts of a lager and represent the true unmet need where they may benefit from a new approved agent <unk> cream.

Speaker 5: Many Vidaligar patients experience psychological, social, and the physical impacts of Vidaligar and represent the true unmet need where they may benefit from a new approved agent like Ruxilitin of Cream.

Speaker 5: Now to look more broadly at our dermatology franchise on slide 7.

Now to look more broadly at our dermatology franchise on slide 17.

Speaker 5: Within our expanding dermatology portfolio, we are pursuing multiple additional indications with raxylidinip cream, including pediatric atopic dermatitis and chronic hand-ex.

Within our expanding dermatology portfolio, we are pursuing multiple additional indications with rux lithium cream, including pediatric atopic dermatitis and chronic hand eczema.

Speaker 5: INCB 54707, our JAK1 specific inhibitor, has been evaluated in vitiligo in patients with larger body surface area of involvement greater than or equal to 8% and is also in phase 2 studies for higher adenitis suppritiva and impurago nodularis.

Incb 540, 707, Jack one specific inhibitor has been evaluating <unk> in patients with larger body surface area of involvement greater than or equal to 8% and he is also in phase II studies for higher Ed Adenitis Super Teva and <unk> and our Dolores.

Speaker 5: We expect results from the Vidal IGO and HS trial in the second half of this year.

We expect results from the vitiligo in Hs trials in the second half of this year.

Speaker 5: There is significant potential with each of these indications, where there are limited treatment options, when some cases no FDA approved treatment.

There is significant potential with each of these indications where there are limited treatment options. When some cases no FDA approved treatments.

Slide 18 shows the opportunity for growth across our portfolio in mpls and graft versus host disease. We expect an NDA submission in the first half of this year for once daily <unk>.

Speaker 5: Slide 18 shows the opportunity for growth across our portfolio in MPNs and GraftVS's hosting.

Speaker 5: We expect an NDA submission in the first half of this year for one daily ruxulate.

Speaker 5: Within myelofibrosis, we have multiple strategies focusing on improving upon the standard of care by either addressing efficacy or safety.

Within myelofibrosis, we have multiple strategies focusing on improving upon the standard of care by either addressing efficacy or safety.

In patients who have an inadequate response to single agent JAK inhibitor combination therapy has the potential to improve efficacy, which we are pursuing through the addition of pasta classic or a bet inhibitor.

Speaker 5: In patients who have an inadequate response to single agent JAK inhibitor, combination therapy has the potential to improve efficacy which we are pursuing through the addition of pongLindyceli's or a beta- transcript components such as stincs and reds or

Speaker 5: Our Phase III program evaluating Ruxilitinus Pospocinib Pococlycerin in inadequate responders and in the first line setting for myroprolysis is ongoing and we expect results in 2023 for the suboptimal study.

Our phase III program evaluating <unk>, plus Pos equipment, plus the classic and inadequate responders and in the first line setting for motto fibrosis is ongoing and we expect results in 2023 for the sub optimal study.

Speaker 5: For patients who are on sub-therapeutic doses due to anemia, these patients may benefit from the addition of an L2 inhibitor. We know that Jackify has been a life-changing therapy for many patients with MF and PV, and we believe we can use our expertise in this area to provide additional options to patients.

For patients who are on sub therapeutic doses due to anemia. These patients may benefit from the addition of an <unk> inhibitor. We know that Jakafi has been a life changing therapy for many patients with MF and PV and and we believe we can use our expertise in this area to provide additional options to patients.

Speaker 5: We continued to work towards addressing the unmet need in patients with graft versus host disease with jack-of-five and other therapies, including Iter Suttonub, a Jack-1 selective inhibitor, being evaluated in treatment naive patients with chronic graft versus host disease, and as previously mentioned, accidental amabas monitor therapy and potentially in combination with the Jack inhibitor.

We continue to work towards addressing the unmet need in patients with graft versus host disease with jakafi and other therapies, including its a citizen of JAK, one selective inhibitor being evaluated in treatment naive patients with chronic graft versus host disease and as previously mentioned <unk> as monotherapy and potentially in combination.

<unk> with the JAK inhibitor.

Turning to slide 19.

Speaker 5: A number of updates are expected this year for some of our earlier stage pipelines.

A number of updates are expected this year for some of our earlier stage pipeline. We expect updated data from our oral PD Lone program later, this year, which could allow us to make decisions on indication and our lead program selection. Additionally.

Speaker 5: We expect updated data from our ROPDL1 program later this year, which could allow us to make decisions on indication and a lead program selection.

Speaker 5: Additionally, we expect data from the Adenosine Programme for both our small molecule A2A, A2B antagonist and our CD73 monoclonal antibody, later this year.

Do you expect data from the adenosine programs for both our small molecule <unk> antagonist and our CD 73 monoclonal antibody later this year.

As you can see on slide 20, we are expecting multiple regulatory and clinical catalysts. This year and we look forward to another very exciting year ahead with that I would like to turn the call over to Christiana for the financial update.

Speaker 5: As you can see on slide 20, we're expecting multiple regulatory and clinical catalysts this year, and we look forward to another very exciting year ahead. With that, I would like to turn the call over to Christiana for the financial update. Thank you, Steven.

Thank you Susan and good morning, everyone.

Speaker 6: Our fourth quarter results reflect continued strong revenue growth with total product and royalty revenues of $813 million, representing an increase of 20% over the fourth quarter of 2020, and reflecting growth across products commercialized by inside and by our parts.

Our fourth quarter results reflect continued strong revenue growth with total product and royalty revenues of $813 million, representing an increase of 20% over the fourth quarter of 2020, and reflecting growth across products commercialized by inside and by our partners.

Speaker 6: Total product and royalty revenues for the quarter are comprised of net product revenues of $592 million for Jakapai, $51 million for either hematology and ecology product, and $5 million for up to rule.

Total product and royalty revenues for the quarter are comprised of net product revenues of $592 million for Jakafi.

$51 million for either hematology oncology products.

$5 million for obsolete.

Speaker 6: Royalties from Novartis of $96 million for Jacobi and $3 million for Tabrecta and royalties from Lilly of $66 million for

Royalties from Novartis of $96 million for Jakafi and $3 million for tablet Axa and royalties from Lilly of $66 million for ILUVIEN.

Speaker 6: This 15% year-over-year growth for JAKA-FI net product sales reflects higher patient demand across all

This 15% year over year growth for Jakafi net product sales reflects higher.

Demand across all indications.

Speaker 6: The doubling of alluminium royalties is driven primarily by the use of alluminium for the treatment of COVID.

The doubling of ILUVIEN drilling and this is driven primarily by the use of ILUVIEN for the treatment of COVID-19, as a reminder for global net sales of ILUVIEN for the treatment of COVID-19, we are entitled to receive royalties equal today, Dave double digit royalties applicable to all global net product sales less.

Speaker 6: As a reminder, for global net sales of aluminum for the treatment of COVID-19, we are entitled to receive royalties equal to the base double-digit royalties applicable to all global net product sales, plus an additional 13% royalty.

An additional 13% for IMT.

Speaker 6: For the full year 2021, total product and royalty revenues were $2.9 billion, and a 17% increase over 20%.

For the full year 2021, total product and royalty revenues were $2 $9 billion and a 17% increase over 2020.

Speaker 6: Focusing now on obselura for the fourth quarter, the launch and volume of prescriptions has been strong. While we are negotiating with TBMs and payers to get obselura and formularies and remove the NDC blocks, we have been utilizing patient-send support programs to cover the full cost of obselura so that patients have access to the product.

Focusing now on <unk> for the fourth quarter, the launch and volume of prescription has been strong while we are negotiating with pbms and payers to get absolute out formularies and remove the mtc blocks will have been utilizing patient support programs to cover the full cost of upsell Laura.

So that patients have access to the product.

Speaker 6: In the fourth quarter, Opselura gross product sales of $58 million were reduced by 75% related to this patient support program.

In the first quarter of Tilda gross product sales of $58 million were reduced by 75% related disease patient support programs.

Speaker 6: In addition, other fees and discounts of 17% contributed to a total gross net discount of 92% for the court.

In addition, other season discounts of 17% contributor.

Total gross to net discount of 92% for the quarter.

Speaker 6: As a result of these reductions, net product sales for the quarter were $5 million.

As a result of these reductions net product sales for the quarter were $5 million.

Moving onto our operating expenses on a GAAP basis ongoing R&D expenses of $345 million for the fourth quarter decreased 9% from the prior year period, primarily due to their accelerated a cream API related costs incurred in the prior year quarter before akshay.

Speaker 6: Moving on to the operating expenses on a gap basis, ongoing R&D expenses of $345 million for the fourth quarter decrease 9% from the prior year period. Primarily due to their actualitinip cream API related costs incurred in the prior year quarter before obseluras regulatory.

Regulatory approval.

Speaker 6: ongoing R&D expense for the full year 2021 of $1.3 billion increased by 6% over 2020, primarily due to the progression of our pipeline.

Ongoing R&D expense for the full year 2021 of one 3 billion increased by 6% over 2020, primarily due to the progression of our pipeline.

Total R&D expense of $473 million for the quarter and $1 $46 billion for the full year 2021 includes the upfront consideration of $527 million for our collaboration agreement with <unk>.

Speaker 6: Total R&D expense of $473 million for the quarter and $1.46 billion for the full year 2021 includes upfront consideration of $127 million for our collaborative agreement with Singapore.

SG&A expense for the fourth quarter of $226 million increased 35% from the prior year period, primarily due to our investments related to the establishment of our new dermatology commercial organization in the U S and the related activities to support the launch of hotel Laura.

Speaker 6: SG&A expense for the fourth quarter of $226 million increased 35% from the prior year period, primarily due to our investments related to the establishment of our new dermatology commercial organization in the U.S. and the related activities to support the launch of Oxellura.

Speaker 6: For the full year 2021, the 43% growth in SG&A expense was also primarily related to the commercialization of.

For the full year 2021, 43% growth in SG&A expense was also primarily related to the commercialization of <unk>.

Speaker 6: Our collaboration loss for the quarter was $8 million representing our 50% share of the US net commercialization loss.

Our collaboration a loss for the quarter was $8 million, representing a 50% share of the U S net commercialization loss, Vermont Julien.

For the full year 2021, the total collaboration loss was $37 million.

Speaker 6: For the full year 2021, the total collaboration loss was 37 million.

Finally, we ended the year with $2 $3 billion in cash and marketable securities.

Speaker 6: Finally, we ended the year with $2.3 billion in cash and marketable.

Looking at the evolution of our P&L you can see how over the past three years the growth in our product and royalty revenues has exceeded the growth in our ongoing R&D and SG&A expenses, leading to increased operating leverage and reflecting our commitment to prudent management of our financial resources.

Speaker 6: As previously discussed, the uptick in expenses in 2021 reflects the built-out of our dermatology franchise and the obselura.

As previously discussed.

Uptick in expenses in 2021 reflects the built out of the rheumatology franchise and the absolute at lunch.

Speaker 6: Moving on to 2022, I will now discuss the components of our guidance on a Godday.

Moving onto 2022, I will now discuss the components of our guidance when they got basi.

Speaker 6: For Jagatvi, we expect net product revenues to be in the range of 2.3 to 2.4 billion dollars, which at midpoint represents an increase of approximately 10 percent over 2021, driven by continued growth across all indicators.

For Jakafi, we expect net product revenues to be in the range of two three to two $4 billion, which at the midpoint represents an increase of approximately 10%.

Over 2021.

<unk> by continued growth across all indications.

Speaker 6: We expect our gross net adjustment for 2022 to be approximately 21%, reflecting expected continued growth in three-forty...

We expect our gross to net adjustment for 2022 to be approximately 21%, reflecting expected continued growth in 340 volumes I say reminder, the gross to net adjustments in the first quarter of the year is always higher relative to the previous quarter and subsequent quarters due to our share of the donut hole.

Speaker 6: As a reminder, the Gloucetanet adjustments in the first quarter of the year is always higher relative to the previous quarter and subsequent quarters. You too are share of the Donat Hall for Medicare Pals.

Medicare part D patients.

For other hematology oncology products, which includes payments made in the U S EU and Japan and Iclusig jewelry in Europe , we are expecting total net product revenues to be in the range of $210 million to $240 million.

Speaker 6: For other hematology-oncology products, which includes Pemazir in the U.S., EU, and Japan, and Alklusik and Minjuvi in Europe , we are expecting total net product revenues to be in the range of 210 to $240 million, which at midpoint represents approximately 23% growth over 2021.

Which at the midpoint represent approximately 23% growth over 2021.

Due to the early stage of its launch we will not be providing guidance on a particular, but that will provide some additional color around obscure our gross to net for 2022 in a moment.

Speaker 6: You to the early stage of its launch will not be providing guidance on the obselura, but I will provide some additional color around obselura gross to net for 2022 in a moment.

Speaker 6: As in previous years, we are also not providing guidance for milestones or royalty revenue.

As in previous years, we are also not providing guidance for milestones or royalty revenues.

Speaker 6: Turning to operating expenses on a GAAP basis, we expect COGS to range from 6-7% of product revenue.

Turning to operating expenses on a GAAP basis, we expect Cogs to range from 6% to 7% of product revenues R&D expense is expected to be in the range of $1 55 to $1 $59 billion, representing 18% growth at the midpoint versus 2021, excluding the.

Speaker 6: R&D expansion is expected to be in the range of $1.55 to $1.59 billion, representing 18% growth at the midpoint versus 2021, excluding the impact of the SINDA Cup front consideration in 2021.

Back of the scene, that's upfront consideration in 2021.

Speaker 6: The growth rate primarily reflects expansion in our dermatology clinical development, as well as investments in our Limber GVHD program, Tafasita Mab, and our PDLO-1 program.

The growth rate, primarily reflects expansion in our dermatology clinical development as well as investments in our limber Gvhd program deficit that mud and RFP there no one program.

We expect SG&A expense for the year to be in the range of 950 million to $1 billion, primarily reflecting continued support for the absolute launch.

Speaker 6: We expect that DNA expands for the year to be in the range of $950 million to $1 billion, but merely reflecting continued support for the Obserura law.

Speaker 6: Excluding the impact of a cellular related cost, we expect S.G.N.A. expense to grow at a rate of less than five.

Excluding the impact of absolute related costs, we expect SG&A expense to grow at a rate of less than 5%.

Speaker 6: With respect to our profit share for Monjuvi in the US, in 2022 we expect to be around breaking.

With respect to our profit share for modules in the U S. In 2022, we expect to be around breakeven.

Speaker 6: As I previously mentioned, while we are not providing guidance for OBSELURA due to the early stage of the launch, I would like to discuss what you could expect related to our gross-to-net adjustment in 2021.

As I previously mentioned, while we are not providing guidance for <unk> due to the early stage of the launch I would like to discuss what you could expect related to add gross to net adjustment in 2022.

Speaker 6: As we finalize coverage with payers, we expect growth to net for obselura to be relatively flat in Q1 compared to Q4 2021. Begin to decline in Q2, and normalize at a fully loaded growth to net rate of 40 to 50% between Q3 and Q4, depending on the timing of the removal of NDC blocks by BBMs, and the discontinuation of certain patient support programs.

As we finalize coverage with payers, we expect the gross to net product sales to be relatively flat in Q1 compared to Q4 2021 begin to decline in Q2 and normalize at the fully loaded gross to net rate of 40% to 50% between Q3 and Q4, depending on the timing of the removal of MDC blocks.

The BMS and the discontinuation of certain patient support programs.

Speaker 1: Operator that concludes our preparing remarks, please give your instructions and open the call for Q&A. Certainly, we now become just a question and answer session. If you'd like to be placed into question Q, please press star one on your telephone key.

Operator that concludes our prepared remarks, please give your instructions and open the call for Q&A.

We will now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment may be necessary to pick up your handset before pressing.

Speaker 1: A confirmation tone will indicate your line is in the question queue. You may press start 2 if you'd like to remove your question from the...

Speaker 1: For participants using speaker equipment, maybe necessary to pick up your handset before pressing star one. One moment please, I'll be pulled for questions.

<unk> Star one one moment, please while we poll for questions.

Speaker 1: Our first question today is coming from Vikram Prud from Morgan Stanley , your lightest allies.

Our first question today is coming from Vikram <unk> from Morgan Stanley . Your line is now live.

Speaker 7: Great. Good morning. Thanks for taking my questions. So I had two on Obsolera. The first on reimbursement progress. I wanted to see if the 40 to 50 percent gross to net that you just guided to for late 22 is expected to be the long-term gross to net you expect.

Great. Good morning, Thanks for taking my questions.

Two on <unk>.

First on reimbursement progress I wanted to see if the 40% 50% of gross to net that you just guided too for a late 'twenty. Two is expected to be the long term gross to net you expect for the product and secondly.

Speaker 7: for the product. And secondly, while it's understandably early, I wanted to see what you might have learned on duration of use so far in terms of which areas of the body, patients find most suitable for the product and the speed at which patients who have received refills have been

While it's understandably early I wanted to see what you might've learned on duration of use so far in terms of which areas of the body patients find most suitable for the product and the speed at which patients who have received refills have been working through tubes.

Speaker 4: Hi Vikram, it's Barry. I can answer your first question. 45 to 50 percent is what we say for this second half of the year.

Hi, Vikram, it's Barry I can answer your first question, 45% to 50% is what we say for this a second half of the year.

Speaker 4: When things stabilize and we hope that continues into the future I can't really predict what the future is going to bring after that but certainly we know that the value of the product to Patients to physicians is high and therefore I think that we can continue to manage and work with The payers to make sure that we have a reasonable gross to net for the product

When things stabilize and we hope that continues into the future I can't really predict what the future is going to bring after that but certainly we know that the value of the product to patients to physicians is high and therefore I think that we can continue to manage and work with the.

Payers to make sure that we have a reasonable gross to net for the product.

Speaker 4: The second question is, is it hard to predict? I mean, patients are using the product everywhere. They're using it on their hands. Their face, obviously, non-suroidal product, like a psalora is good to use, on sensitive areas, including the face.

The second question is just hard to predict I mean Ah patients are using the product.

Where are they using on their hands their face obviously, a nonsteroidal product like <unk> is good to use in sensitive areas, including the face and other sensitive areas. So.

Speaker 4: other sensitive areas, so I don't know. The refills are coming in. They're increasing each and every month. Obviously, as more and more patients come on, most of them have gotten one tube so far, and then perhaps 15% of them have gotten a refill, and those refills will continue. We'll obviously have more data for you.

I don't know the refills are coming in they are increasing each and every month obviously.

As more and more patients come on most of them have gotten one tube so far and then perhaps.

Perhaps 15% of them have gotten a refilling those refills will continue it will obviously have more data for you in the future, particularly about refills and that's a very important component of our continued growth.

Speaker 4: In the future, particularly about refills, and that's a very important component of our continued growth. But as far as the areas of body they're using your drug on, I'm sure it's going to be all areas where they have continued problems with and with eczema with atopic dermatitis.

But as far as the areas of body. They are using the drug on I'm sure it's going to be all areas, where they have a continued problems with <unk> with.

With eczema with atopic dermatitis.

Okay understood. Thank you.

Yes.

Thank you. Our next question today is coming from Brian Abrahams from RBC capital markets. Your line is now live.

Speaker 1: Thank you. Our next question today is coming from Brian Abrams from RBC Capital Markets. Your line is now live.

Speaker 8: Hey, guys. Thanks so much for taking my questions. Congrats on all the progress. Another question on Opsalora.

Hey, guys. Thanks, so much for taking my question and congrats on all the progress another question on <unk>.

Can you clarify how the patient journey and potential barriers to uptake and reimbursement.

Speaker 4: evolve as gross to net equilibrates by the back half of this year and you shift from the current patient support programs to co-pay assistance, I guess I'm sort of wondering if we should expect any additional hurdles to adoption once we're through this initial launch period. And then, secondarily, maybe just asking the prior question a little bit differently, I guess I'm curious how the 15 percent refill rate aligns initially with your expectations for the number of tubes patients would use per year, granted, obviously, early days. Thanks. As far as patient journey goes, I mean, obviously, the

It evolves as gross to net equilibrate by the back half of this year and you shift from the current patient support programs too.

Co pay assistance I guess I'm sort of wondering if we should expect any additional hurdles to adoption of once we're through this initial launch period and then secondarily, maybe just asking the prior question little bit differently, I guess, I'm curious how that 15% refill rate aligns initially with your expectations for the number of tubes patients.

Would use per year.

Speaker 8: Granded obviously early days. Thanks.

Granted obviously early days.

Speaker 4: As far as patient journey goes, I mean, obviously, there's millions of patients that have eczema, atopic dermatitis, today throughout the United States.

As far as patient journey, because I mean, obviously, there's millions of patients that have asthma atopic dermatitis today throughout the United States.

Speaker 4: They've been cycling through low-potency steroids, high-potency steroids.

They've been cycling through low potency steroids high potency steroids.

Speaker 4: And then TCI's and so we don't really anticipate any future barriers whatsoever. We anticipate increase the man for the product both from physicians and from patients because the more experience that they continue to have with the drug, the more happy they are with the drug.

And then TCE is and so there we don't really anticipate any future barriers whatsoever, we anticipate increased demand for the product both from physicians and from patients because the more experience that they continue to have with the drug the more happy they are with the drug.

Speaker 4: Um, so, um, while we, uh, I mean, this is common, uh, in fact, for, um.

So.

While we are I mean this is common in fact for.

Speaker 4: new products launching in areas like atopic dermatitis or psoriasis to have a period of time where you're covering until coverage Sort of one of the things we like to say is that we're going to make sure that if a prescription is written by a dermatologist by a dermatology office

New products launching in areas like atopic dermatitis or psoriasis to have a period of time, where you're covering until coverage sort of one of the things. We like to say is that we're going to make sure that if a prescription is written by a dermatologist bioterror metallurgy office.

Speaker 4: it's going to be, the patient's going to be able to get it.

It's going to be a patient is going to be able to get it and they're going to be able to get it now in the early periods of time with our health, but as coverage comes online which is coming online every single day, we expect that the gross to net will improve and that the barriers. If there is any barriers will be removed as far as the reef.

Speaker 4: and it can be able to get it now in the early periods of time with our health, but as coverage comes online, which is coming online every single day.

Speaker 4: We expect that the gross net will improve and that the barriers, if there is any barriers, will be removed.

Fill volume, it's very early and we actually think that this will continue patients are coming back all the time and I think you'll see the refill percentage continue to increase.

Speaker 4: with the new prescription volume. And obviously as we move into Vidaligo, things will even get better. Well, even new RX is going up and then those patients will be coming back for refills as well.

With the new prescription volume and obviously as we move into vitiligo things will even get better without even new Rx is going up and then those patients will be coming back off of refills as well.

Great. Thanks, so much.

Speaker 1: The next question today is coming from Tazina Mon from Beckable America. Your life is now life.

Thank you. Our next question today is coming from <unk> from Bank of America. Your line is now live.

Speaker 9: Hi, good morning. Thank you for taking my questions. A couple from me and Opsilura as well. Can you give us any kind of color on where the use is coming from in the early days? Are these patients naive to any treatment before or are you seeing switches? And if you are seeing switches, where is that coming from? And then, second question, as we think about when your broskinet will normalize towards the end of the year.

Hi, Good morning, Thank you for taking my questions.

From an absolute era as well.

Give us any kind of color on where the use is coming from in the early days are these patients naive to any treatment before or are you seeing switches and if you are seeing switches where is that coming from.

And then second question as we think about when your gross to net will normalize with me enter the year.

Speaker 9: You know, how much do you think at max a patient will have to pay out his pocket fee on treatment? But you know, what kind of views you have on elasticity of demand is related to what the co-pay should be. And can you give us an idea of what that range is? I think.

How much do you think at Max eight patient will have to pay out of pocket treatment, but you know what what kind of do you have on an elasticity of demand as it relates to what the co pay should be and can you give us an idea of what that range yet.

Speaker 4: Sure, so Barry again, so the switch is the vast majority of patients are coming off as steroids. They have been prior treated with steroids.

Sure So Barry again so.

The switches.

Asked majority of patients are coming off of steroids. They have been prior treated with steroids, but it's everything in fact.

Speaker 4: But it's everything. In fact, patients who have been treated with depictions, with Eucrissa, with TCI's, they're all coming off therapy or have been prior treated with those drugs and maybe they're not getting relief and now they're getting relief.

<unk>, who have been treated with.

With <unk> with you Chris with TCE is they're all coming off therapy or have been prior treated with those drugs and maybe theyre not getting relief and now theyre getting relief or.

Speaker 4: or switching to Opsilura. So it's really mostly steroids and that's what we expected because you know We think this is the perfect product for patients with atopic dermatitis From the beginning from steroids all the way up to injectable biologics and there's millions of patients right there that we can

Switching to <unk>, so, it's really mostly steroids and that's what we expected because we think this is the perfect product for patients with atopic dermatitis from the beginning from steroids, all the way up to injectable biologics and there's millions of patients right. There that we can.

Help with this drug.

Speaker 4: The second part of your question was, oh, out of pockets. Well, I think what I said is that no patients will have to pay more than $10 out of pockets. What we expect, of course, is that more and more of the plans

The second part of your question was Oh out of pocket as well, but I think what I've said is that no patients will have to pay more than $10 out of pocket well. We expect of course is that more and more of the plans.

Speaker 4: The insurance will pick up the cost of the drug. Some of them obviously have high deductibles. Some of them have low deductibles. Some of them just have a $10 crore pay.

Their insurance will pick up the cost of the drug some of them, obviously have high deductible or some of them have loaded up with some of them just have a $10 copay.

Speaker 4: When they're covered by commercial insurance, but patients will have to pay no more than ten dollars And that's what we guarantee and to be quite quite honest. That's what you know many other drug companies Do they keep the out-of-pocket cost to patients?

When they're covered by commercial insurance, but patients will have to pay no more than $10 and that's what we guarantee and to be quite quite honest. That's what so many other drug companies do they keep the out of pocket cost to patients low now Ah patients on different tiers tend to have a different co pay and it could average out.

Speaker 4: low now uh... patients on different tiers tend to have a different copay and it could average a tear you know that your one that they have a ten dollar copay or no copay and that the average is somewhere between sixty seven seventy dollars if it's tier two or tier three uh... it's the rare patient that really has a big uh... again a copay that uh... that we have to pick up

Tier tier one that they have a $10 copay or no co pay and then the average is somewhere between 60 to $770 if its tier two or tier three.

It's the rare patient that really has a big gigantic co pay that are then we have to pick up.

Okay, I'm asking just because I think you know.

Speaker 2: Okay, I'm asking just because, as I think, you know, about your future growth to that, to the question I was asked earlier, could this be a potential driver at your desire to make sure that the market is no more than $1.00, did that play a role potentially in making your growth to have in the future a bit more valuable than what you would expect it to be?

About your future growth.

And that was asked earlier could this be a potential driver.

Just make sure that the market is no more than $10 that play a role potentially in.

Making your gross do you have any teacher a bit more variable than what you expected.

So with that gena.

Speaker 6: The Coupe assistance is reflected in the 40 to 50% range at steady state that we have indicated.

The copay assistance is reflected in the 40% to 50% range at steady state because that would have indicated.

Okay. Thank you.

Thank you. Your next question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Speaker 1: Thank you. Next question today is coming from Jay Olson from Oppenheimer, your line is now lies.

Oh, Hey, thanks for the update and for taking the question.

Speaker 7: Maybe a big picture question, since Insight has made a lot of progress diversifying the product portfolio beyond Jackify, I was wondering how much of a priority do you place on geographic revenue diversification, especially since you're expecting a lot of revenue growth from your dermatology business, which seems like mostly a U.S.-focused opportunity. Are there growth opportunities that you expect to expand your revenues beyond the U.S.?

Maybe a big picture question since insight has made a lot of progress diversifying the product portfolio beyond Jakafi I was wondering how much of a priority do you place on geographic revenue diversification, especially since you are expecting a lot of revenue growth from your dermatology business, which seem.

Like mostly a U S focused opportunity are there growth opportunities that you expect to expand your revenues beyond the U S.

Yeah.

Yes.

Speaker 3: Yes, with Herve here. If you remember a few years ago, we made that decision to go and build our own organization in Japan and Europe .

Yeah.

If you remember if she also go we made that decision to go and.

<unk> built our own organization in Japan, and Europe , and you can see as a result of that is starting to emerge. So we have had the iclusig phone number you know we haven't been Julien vimizim launching in Europe , so that will contribute to that.

Speaker 3: And you can see the result of that is starting to emerge. So we have had Iqzik for a number of years. Now we have Minjouvi and Pemezzi are launching in Europe . So that will contribute to that diversification and we launched Pemezzi in Japan, which is a small number to this day. But we have a development organization also in Japan. As you know, we have partnerships in China.

Diversification and we launched a payments here in Japan, which is a smaller number two to this day, but we have a development organization those screens up out as you know we have partnerships in China.

Speaker 3: that are very important and doing very well. And for the rest of the world, we are, in fact, as we speak,

A very important on the I'm doing very well.

Around the rest of the World. We are in fact as we speak.

Speaker 3: Signing distribution agreements that will give us another layer of

Signing distribution agreements that will give us another year of over diversification. So is it maps to the four insight is a map that includes for every project, Japan, Europe and U S.

Speaker 3: of diversification. So the map today for Insight is a map that includes for every project, Japan, Europe , and the U.S.

Speaker 3: And we think it's very important from the development standpoint because we know these studies are always a picker. Most of the time I'm applicable across the world.

We think it's very important for us from the development standpoint, because we know this there is always a peak at all most of the time actually give out across the world.

Speaker 3: And we intend to keep that for the next few years as the footprint for insight with the big question of China where we have a number of products that are already partnered and we are looking at what we could do.

The and we intend to keep that for the next few years as the footprint for inside.

He is the big question of China, where we have a number of products that are already partner and we are looking at what we could do with some of the new pipeline products that we are developing for the for the future. So is that the big draw we have and I think it's an important it's an important aspect of the risk of our portfolio is that it's not all.

Speaker 3: with some of the new pipeline products that we are developing for the future. So that's the picture we have, and I think it's an important aspect of the risk of our portfolio is that it's not all based on the U.S.

Based on the U S.

Speaker 3: sales, even if today it's still a big majority of our business.

Sales.

Even if today still the big majority of our business.

Great. Thanks for taking my question.

Thank you. Your next question today is coming from Marc Frahm from Cowen <unk> Company. Your line is now live.

Speaker 1: Thank you. Your next question today is coming from Mark Fromm from Cowen & Company. Your line is now live.

Speaker 10: Thanks for taking my questions. Maybe just to probe on the question a little bit more, does the guidance and kind of the trajectory through the year contemplate the vitiligo indication, you know, or is that already kind of being baked into some of these contracts, the ability to launch that more rapidly in terms of, you know, reimbursing?

Hi, Thanks for taking my questions.

Just to probe on the Christian had a little bit more does that guidance and kind of the trajectory through the year.

Contemplate the vitiligo indication or is that already kind of been baked into some of these contracts the ability to launch that more rapidly in terms of reimbursement and things.

Speaker 10: Or should we expect a lot of free drug to come in and maybe have to adjust that guidance once that label?

Or should we expect a lot of free drug to come in and maybe have to adjust that guidance you know once that labels issue.

Speaker 4: Sure Mark's Barry, no the guidance is included of the Lego launch.

Sure Mark Barry I know the guidance is included vitiligo launch.

Speaker 4: Now when really the leg goes approved, of course, so we don't have to go back and do new contracts with the GPO's last PBMs again for Opsilora, but each of the plans, because now you have hundreds of downstream plans, obviously right there on utilization criteria and add the drug to the formulary and that takes a little bit of time. But other than that, the drugs available, it will be available to the legal patients. They can prescribe it and it just has to take a little bit of time for the...

Now in Vitiligo is approved of course, so we don't have to go back and do new contracts with the GPO Slash Pbms again for for absolute error, but each of the plants. Because now you have hundreds of downstream plants, obviously write their own utilization criteria.

And as a drug to a formulary and that takes a little bit of time, but other than that.

Regs available it will be available to patients.

They can prescribe it and and it just has to take a little bit of time for the <unk>.

Speaker 4: for the various plans to add it to their formulary or update their utilization criteria.

For the various plants added to their formulary or update their utilization criteria.

Okay, Great. That's helpful. And then maybe just as a follow up.

Speaker 10: Great, let me just follow up in terms of some of the marketing activities. You initially launched with samples, which there's an update that you can provide on the texture issue and the ability to relaunch those samples.

In terms of some of the marketing activities you initially launched with samples.

Don't know if there's an update that you can provide on kind of the texture of fueling.

The ability to relaunch that those samples and.

Speaker 10: and the importance you see of getting those out there very related to the marketing. On the guidance on the Estonian NACE, the previous prior conversations, you and Barry have talked about possible needs for a DTC ad series that are already contemplated in the guidance.

The important tcs of getting those out there Barry and related to the marketing on the guidance on the SG&A side Christiane before in prior conversations you and Barry talked about possible need for DTC ads series, that's already contemplated in the guidance or not.

So let me start with the last question and then I'll turn it to Steven that too.

Speaker 6: So let me start with the last question and then I'll turn it to Steven to give you an update on the texture issues. In terms of this.

To give you an update on it actually shows up.

In terms of the SG&A guidance.

Speaker 6: It does reflect all costs associated with commercializing and marketing and supporting the Obserura launch, including DTC. Also one thing that I think is worth noting as you look at the guidance that we have provided for SGNA and NRN.

It does reflect all costs associated with our commercializing and marketing and supporting at launch so including DTC also one thing that I think it is worth noting as you look at the guidance that we have provided for SG&A and R&D.

Speaker 6: It covers costs associated with both HEMONC as well as dermatology. So the SGNA guidance fully reflects costs associated with Opthalura. However, when you look at the revenue guidance that we have provided, there we have provided guidance on just the HEMONC part of the business, including MPNs. So you have part of the picture, you don't have the other part in terms of the Opthalura as well as Royal.

Is it eight call there's costs associated with both CE, Mark as well as dermatology. So the SG&A guidance fully reflects costs associated with obtaining however, when you look at the revenue guidance that we have provided there we have provided guidance on just the Cmos.

Part of the business, including empty and so you have part of the picture you don't have the other part in terms of singular, that's where lesser royalties and lifestyle.

Marc It's Steven on your on your texture issue so.

Speaker 5: Mark, it's Steven on your texture issues. So, you know, as you heard, we in the midst of a very successful launch and we've been able to maintain a healthy commercial supply for that.

As you as you heard in the midst of a very successful launch and we've been able to maintain a healthy commercial supply for that Additionally, as we said with vitiligo. The <unk> date is April 18, and obviously, we want to have a very healthy commercial supply for that as well given that at the current time the <unk>.

Speaker 5: Additionally, as we said, we put a little I go, the Purdue for Dates is April 18th, and obviously we want to have a very healthy commercial supply for that as well. Given that, at the current time, the manufacturing of samples will have to wait a little bit later on. We want to get it done as soon as possible, but we're focusing on the commercial supply.

And affection of samples will have to wait a little bit later on we wanted to get it done as soon as possible, but we're focusing on the commercial supply. We knew early on in terms of the texture that this was due to a is extremely small amount of crystal formation that we know is <unk>. It's it's API that has come out of solution.

Speaker 5: We knew early on in terms of the texture that this was due to a extremely small amount of crystal formation that we know is Ruxilitna. It's API that has come out of solution.

Speaker 5: And we've been focusing on process improvements that will improve solubility and avoid this issue.

And we've been focusing on process improvements that will improve solubility and avoid this issue.

Speaker 5: Some of these changes are feasible within the NDA specifications and can be implemented immediately. And some require regulatory back and forth and submissions and wait for the FDA approval to implement.

Some of these changes are feasible within the NDA specifications and it can be implemented immediately and some are required regulatory back and forth and submissions and wait for the FDA approval to implement.

Speaker 5: But at the present time, we've been able to maintain a very healthy commercial supply and we'll continue to, with the focus on both AD and the upcoming Velligo and then as soon as possible, they're after, you know, manufacturer samples as well.

But at the present time, we've been able to maintain a very healthy commercial supply and.

And we will continue to with the focus on both <unk> and the upcoming vitiligo and then as soon as possible thereafter manufacturers' samples as well.

Alright, thanks very helpful.

Speaker 1: Our next question today is coming from Corey Kazemov from JP Morgan. Your line is now live.

Thank you. Our next question today is coming from Cory CASM all from J P. Morgan Your line is now live.

Speaker 11: Good morning guys, thanks for the question. This is Tiffany on for Corey. Just one other one on Obsolera. How confident is insight in reversing the NDC block for the second major payer plan? And in a case that that block isn't removed, can you speak to the potential future and past and sales that you might anticipate?

Good morning, guys. Thanks for the question. This is Stephanie on for Corey just one other one on <unk> how confidant.

And the first thing the M. D. C blocks are second nature to your plan and in the case that that block isn't furnace can you speak to the potential future impact.

Sales that you might anticipate.

Thanks.

Speaker 4: Well, we're very confident in removing the NDC blocks. We're in active advanced negotiations with them. The first part is, you know, signing these base agreements to get all of the

Well, we're very confident it's Barry again, so we're very confident in removing the mtc blocks were in active advanced negotiations with them. The first part is signing these base agreements.

To get all of the.

Speaker 4: Contract specifications locked up, so we know how to proceed going forward, knowing what the base rebates are, what the rebates would be for, for example, if there is one step, two steps, that sort of thing, it's sort of a menu approach.

Contract specifications are locked up so we know how to proceed going forward knowing.

Knowing what the base rebates are what the rebates would be for for example, if there is one.

Step two steps that sort of thing, it's a sort of a menu approach. So the team is actively negotiating right now we're very confident there's a great demand for this drug does a great push from the downstream plans you know as you know all these pbms arent just working for one insurance company, they're working for many insurance companies are getting contracts for many insurance companies and <unk>.

Speaker 4: So the team is actively negotiating right now. We're very confident. There's a great demand for this drug. There's a great push from the downstream plans. You know, as you know, all these PBMs aren't just working for one insurance company. They're working for many insurance companies. They're getting contracts for many insurance companies.

Speaker 4: And many of those have already established and put up Laura on formulae and established utilization criteria. And of course, they're not getting any rebate now. They're paying at WACC. So they're pushing to get all of the NDC blocks removed. And even when patients have an NDC block, you can still overcome that NDC block with a prior approval in a medical exception. So.

Many of those have already established.

And put ups, Laura on formulary and establish utilization criteria and of course, they're not getting any rebate now they're paying at WAC. So they are pushing to.

To get all of the MDC blocks removed and even when patients have an MVC black you can still overcome that MPC black with a prior approval in a medical exception so.

Speaker 4: uh... you know other companies live with nbc blocks forever because uh... they might not be able to negotiate with one or two

You know other companies live with MDC blocks forever, because they might not be able to negotiate with one or two particular pbms were very confident that we're going to be able to do this because of the value proposition offers both to patients and physicians, but also to the payers themselves. Because this is an effective therapy that most patients who.

Speaker 4: particular PBMs, we're very confident that we're going to be able to do this because of the value proposition it offers both to patients.

Speaker 4: and physicians, but also to the payers themselves because this is an effective therapy that most patients who are treated, 88% of them are become clear over time and therefore they don't need any other therapies. So it's really the value proposition that will make them want to have this product on formularity under contract and to be able to get their rebate and fees that they desire.

We're treated 88% of them are clear.

Become clear over time, and therefore, they don't need any other therapy. So it's really the value proposition that will make them want to have this product on formulary.

Under contract and to be able to get their rebates rebating fees that they desire.

Okay.

Got it thanks.

Speaker 1: Thank you. Next question is coming from Michael Schmidt from Grooverheim Securities. Your line is now on.

Thank you. Our next question is coming from Michael Schmidt from Guggenheim Securities. Your line is now live.

Oh, Hey.

Speaker 11: I have a question for Michael. Thanks for taking our question. Another one on Absorura. I guess clarifying on a prior question, what did you say was the anticipated contracting process for the label expansion into Vidal Igo, and then regarding the sales force, I guess what's being done there to kind of prepare for the launch.

Michael Thank you for taking our question one other one on <unk> I guess.

We're flying on a prior question what did you say it was be anticipated contracting process for the label expansion into vitiligo and then regarding the sales force I guess, what's being done there to kind of prepare for the launch. Thank you.

[noise] contracting quite well I would I explained before is we don't need to go back to the Pbms that we already have contracts with and the pbms that where a.

Speaker 4: The contract and... well, I would explain before if we don't need to go back to the PBMs that we're already have contracts with and the PBMs that were in GPUs that were currently.

G P OS that we're currently.

Speaker 4: Contracting with for the full NBC block the the LIGO being Included in that process, but the whole step process is that then the downstream Plans across the country just have to add it to their to their formula area So that's just a P&T committee decision our market access teams works with all of those plans across the country to get that on formulary and

Contracting with for the full LTC block the language being prudent and included in that process, but the whole step processes, but then the downstream plans across the country just have to add it to their.

To their formulary. So that's just a PNT.

Committee decision our market access team works with all of those plans across the country.

Get that are on formulary and and have utilization criteria in place as soon as possible. After lunch in fact, they can work with them now talk about the true.

Speaker 4: and have utilization criteria in place as soon as possible after launch. In fact, they can work with them now, talk about the true true V data for for the vitiligo indication and and hopefully very soon after launch all of them will have the drug on the formulary. So we don't have to go back to the PPM GPOs again for vitiligo. As far as the Salesforce

<unk> data.

For for Vitiligo indication and and hopefully very soon after launch all of them will have the drug on formulary. So we don't have to go back to the Pbms GPO is again.

For vitiligo as far as the sales force getting ready.

Speaker 4: It is tricky, I have to admit, we're concentrating on accelerating the AD launch, it's going very well, everybody's very excited about it, but of course we have a dedicated team working on the Vidal-Ligo launch, to be honest, we work...

It is tricky I have to admit we're concentrating on.

On accelerating the launch is going very well everybody is very excited about it but of course, we have a dedicated team working on is it a lag of a launch to be honest we work.

Speaker 4: with our advocacy groups, our patient groups that are very interested.

With.

With our advocacy groups are patient groups that are very interested in and getting a drug approved for vitiligo. You know there's been a great deal of interest both from a payer's dermatologist, yeah. What really helped it was the patient focused drug development meeting that the FDA held on dental.

Speaker 4: In in getting a drug approved for vitiligo, you know, there's been a great deal of interest both from payers dermatologists

Speaker 4: What really helped was the patient-focused drug development meeting that the FDA held on vitiligo and emphasized the great need for a treatment like Opsalura for vitiligo.

Lego and emphasize the.

The great need for a treatment like absolutely for vitiligo.

Speaker 4: because these patients are really suffering and this is the first true drug that can

Because these patients are really suffering and this is the first true.

Drug that can repay.

Speaker 4: Repigment the skin and hopefully improve the quality of life.

<unk> pigment to skin and hopefully improve the quality of life for them.

Speaker 12: And it's the same sales, and if you're what you're asking is the size of the sales force. It's the same sales force, it's the same number of people going to see the same same dermatologist. So there's no expansion there, of course, there's some investments in advertising and promotion, but that's already figured into the STA that we laid out for this year. Great, thank you so much.

And it's the same sales and if you what you're asking is the size of the sales force. So it's the same sales force. It's the same number of people going to see the same same dermatology. So theres no expansion there of course, there's some investments in advertising and promotion, but that's already figured into the SG&A that we laid out for this year.

Alright, great. Thank you so much.

Thank you. Your next call is coming from Ren Benjamin from JMP Securities. Your line is now live.

Hey, good morning, guys. Thanks for taking the questions and an outstanding quarter and congratulations on the guidance going forward.

Speaker 13: Hey, good morning guys. Thanks for taking the questions in an outstanding quarter and congratulations on the guidance going forward.

Speaker 13: A couple of questions for us. If we think about one daily rocks in the NBA submission, can you just...

A couple of questions for us if we think about once daily rocks and the NDA submission can you just remind US do you think it's just a 12 month review and then maybe more importantly does it find its way to the market right away or is this something strategically you might wait until.

Speaker 13: Remind us, do you think it's just a 12-month review? And then maybe more importantly, does it, you know, find its way to the market right away or is this something strategically you might wait until, you know, the twice-daily patent expiration nears? So just a strategy update there.

The twice daily patent expiration nears. So just a strategy update there and then second question as we think about a mid <unk> launch in Europe . So Germany is on board can you talk about how the rest of the rollout.

Speaker 13: And then the second question, as we think about Minjuvi's launch in Europe , so Germany's on board, can you talk about how the rest of the rollout...

Speaker 13: might occur throughout Europe and you know i noticed with peak revenues you'd be you know if you need to kind of don't have uh... any from india in Europe but i'd love to get a sense of that you know why that is or or how you're thinking about pete people

Current throughout Europe , and you know I noticed with peak revenues.

You kind of don't have any firm and UV in Europe , but I'd love to get a sense as to.

Why that is or how youre thinking about peak revenue.

Ren Hi, it's Steven I'll start on the first question related to the regulatory review of once daily rack. So just to remind you we completed bioavailability and bioequivalence work within the FDA specifications for that and then the different strengths are put down instability.

Speaker 5: Ren Hyatt, Steven Oston, your first question related to the regulatory review of one daily rack. So just remind you, we completed bi availability and biocrovalence work. We're within...

Speaker 5: The FDA specifications for that and then the different strengths are put down in stability.

Speaker 3: As soon as that completes, we will file the first half of this year. We expect a 10-month review, a standard review. So it's likely to be right at the end of this year, early next year, that we'll get a regulatory action related to that, just to clarify that time. As for the launch dynamics, there are... I can speak about that. I mean, the... So as you have seen, I mean, the uptake in Germany specifically has been very good. So there is a sense that...

As soon as that completes we will file the first half of this year. We expect a 10 month review a standard review so it's likely to be right at the end of this year early next year that would get a regulatory action related to that just to clarify that time as for the launch dynamics. There all I can speak about that I mean, the so.

As you have seen I mean the.

Uptake in the in Germany, specifically has been very good. So there is a there is a sense that the.

Speaker 3: the launch is doing well, where it's taking place. And as usual, in Europe , as you know, we have to go through reimbursement across a number of countries. So what you will see over the next months are new countries where we are launching coming on board. And hopefully the same type of dynamic taking place there. Now, picked from in Jouvi, we never...

The launch is doing well.

Where it's taking place on as usual in Europe . As you know we have to go through reimbursement across a number of countries. So what you will see over the next.

Moen saw new countries are where we are launching are coming on board and hopefully the same type of a dynamic taking place there no big form in Juvie, we never do.

Speaker 3: You know, this closed it, as you know, in Europe , prices or net prices are somewhat lower than what we have in the US. But volume tend to be higher because of universal access. And so we think at the end of the day, the potential for Minjouvi is meaningful and it will be a key contributor for us. As you know, we are not...

<unk> disclosed it as you know.

In Europe .

You know prices are met prices are somewhat lower than what we have in the U S.

But volumes tend to be higher because of you need a success.

And so we think at the end of the day, but I'm sure from injury is is meaningful.

It will be a key contributor for it because you know we are not.

Speaker 3: booking revenue in the U.S., but we are in the rest of the world. So that will contribute to our net product revenue growth over the next year.

Hum.

<unk> revenue in the U S. But we are in the rest of the world. So that will contribute to our net product revenue growth of over the next year.

Speaker 13: got it and just just uh... uh... to clarify regarding once daily rocks that you know what once you get what's uh... uh... hopefully an approval that that hit the market right away or is that something that you you'll hold back on until until later

Got it and just just to clarify regarding once daily Rux does that you know once you get plus hopefully.

Hopefully around approval does that hit the market right away or is that something that you you hold back on until until later.

Speaker 3: I think, as you know, the Once Daily works, the key aspect of it is the ability to combine with Once Daily products that are also used in myelofibrosis.

I think as you know the ones that erodes the key.

Aspect of it is the ability to combine with Wednesday. The products that are also used in the myelofibrosis. So that's the key strategic aspect, particularly when we launch it so do we get approval or will there be a delay.

Speaker 3: The key strategic aspect, tactically, will we launch it the day we get approval or will there be a delay?

Speaker 3: We frankly don't know yet, so I don't want to give you precise information on that because we are looking at what kind of impact it could have to the overall Jakafi business and obviously

We frankly don't know yet so I don't want to give you a precise information on that because we are looking at what it would what kind of impact it could have to the overall jakafi business. Obviously, we don't want that thing back to be to be negative. So we are we are looking at it but I think it could be something that would be available to us certainly.

Speaker 3: We don't want that impact to be negative. So we are looking at it, but I think it could be something that would be available certainly in the years following the, you know, from today, but it may be at the time of approval or a little later depending practically on what's best for the franchise. Perfect, thanks.

In the U S. Following the.

From today, but maybe at the time of approval or little later, depending tactically on what's the best for the franchise.

Terrific, Thanks, and congratulations again.

Thank you. Our next question is coming from Matt Phipps from William Blair. Your line is now live.

Speaker 1: Thank you. Our next question is coming from Matt Tips from William Blair. Your line is in our line.

Yeah.

Well, it's another one on the limber program, but the two combination what are you really looking for with the FDA later this year or is it primarily going to focus on changes in hemoglobin levels or can we expect some conversion of patients are transfusion independent and maybe compare that to what we saw recently with the mobile lot their results.

Speaker 10: Good morning, Allison. I'm on the LEMBA program, but the out two combination, what are you really looking for with the update later this year is primarily gonna focus on changing the hemoglobin levels or can we expect some conversion of patients to trans-usion and dependant and maybe compare that to what we saw recently with the MOLLA in their results.

Yeah, Hi, it's Steven I'll take your question. So just to remind is as part of <unk>. There are multiple aspects theres a formulation work. We just spoke about with the once daily formulation and then the different combinations. The most advanced of which is the Pos the closer in the sub optimal and first line settings, which is in pivotal studies and then are better than <unk>.

Speaker 5: Hi, Steven, I'll take your question. So just to remind us, as part of LIMBA, you know, their multiple aspects, there's a formulation work we just spoke about for the one-stay-le-formulation. And then the different combinations, the most advanced of which is the POSTA Cliffsib in the suboptimal and first line settings, which is in pivotal studies. And then our bet and L2 program.

Graham.

Speaker 5: For L2, we tremendously excited by it because it's a specific potent inhibitor of L2, as opposed to the moment that you mentioned.

L. Two we were tremendously excited by it because it's a specific potent inhibitor of <unk> two as opposed to letting up which you mentioned, which is probably a week a JAK inhibitor with this off target elk to effect, but it does seem to alleviate anemia, there and Thats why are we so excited for this program what we what we aimed at the most.

Speaker 5: which is probably a weaker, you know, JAK inhibitor with this off-target ELK2 effect, but does seem to alleviate anemia there, and that's why we're so excited for this program.

Speaker 5: What we're in at the moment is the monetary safety and dose escalation and already with that.

<unk> is the monotherapy safety and dose escalation in already with that we've seen <unk> kinetics and episodic kinetics that are favorable so hip saddens decreasing so we know it's working through the mechanism of action. We wanted to work and the kinetics are going the way we want.

Speaker 5: We've seen iron kinetics and epsadon kinetics that are favorable. So epsadons decrease in, so we know it's working.

Speaker 5: Through the maxima of action we wanted to work and the iron kinetics are going the way we want.

Speaker 5: Over time that should translate to a hemoglobin increase and that's what we'll be trying to demonstrate this year. You know with that we'll have proof of concept and we go very quickly to a Rucks combo. We'll be doing Rucks elke safety anyway. And that combination's promise is twofold.

Over time that should translate to a hemoglobin increase and that's what we'll be trying to demonstrate this year with that we'll have proof of concept and we'd go very quickly to a rux combo will be doing rocks elk safety anyway.

And that combination has promise is two fold or maybe even three fold. So one it'll address potentially the underlying anemia for myelofibrosis itself and then we know forex lithium while an incredibly effective drug about 20% to 25% of patients tend to have anemia, with the dragon, sometimes discontinue or can't tolerate high doses.

Speaker 5: or maybe even threefold. So one, it'll address potentially the underlying anemia from a lafabrosis itself.

Speaker 5: And then we know for roxalitinib, while an incredibly effective drug, about 20-25% of patients

Speaker 5: tend to have anemia with the drug and sometimes discontinue or can't tolerate high doses because of that.

Because of that so a neat alleviating the anemia of the underlying disease alleviating the anemia from rocks will allow you to maintain rux dose intensity as well and translate also to have better efficacy. So we believe that the promise of that combination is large and we wanted to get a lot more.

Speaker 5: So alleviating the enemy of the undeline disease, alleviating the enemy from rock.

Speaker 5: will allow you to maintain RAC dose intensity as well and translate also to a better efficacy.

Speaker 5: So we believe that the promise of that combination is large, and we want to get a lot more both safety data this year plus iron, hypsidon, and hemoglobin.

Both safety data this year, plus I'm hip side in hemoglobin data as well.

<unk>.

Speaker 1: Thank you and next question is coming from Salveen Richter from Goldman Sachs, for line is now lost.

Thank you. My next question is coming from Celgene Ritchie from Goldman Sachs. Your line is now live.

Hi, Thanks, This is Matt on for Celgene.

Speaker 14: Hi, thanks. This is Matt on for Salveen. Congrats on the quarter. I said two quick questions on Opsalura.

Congrats on the quarter. So two quick questions on obsolete.

First I just wanted to confirm that you expect agreements with third P. P M.

Speaker 14: I just want to confirm that you expect agreements with the third PPM, so third PPM to be finalized this year. And do you have any expectations on the timing of that?

Third P. P M to be finalized this year and do you have any expectations on the timing of that.

Speaker 14: And then secondly, could you discuss the chronic hand eczema opportunity? What kind of potential dosing would you expect there? And you're starting phase three this year. Should we expect data before year end? Thanks a lot.

And then secondly could you discuss the chronic hand eczema opportunity.

Kind of potential dosing would you expect there.

Youre starting to phase III this year should we expect data.

Before yearend thanks a lot.

Sure. So I'll answer the first part of the question, maybe Stephen can jump in a little bit on kind of can.

Speaker 4: Sure, so I'll answer the first part of the question, maybe Steven can jump in a little bit on a chronic hand.

Speaker 4: So, yes, we expect all of the agreements that I discussed, the third PBM coming on board this year, and then the NDC blocks removing for all of the PBMs this year. So, that's what our expectation is. Chronic hand eczema, I think it is an opportunity for us. It's a severe disease that's difficult to handle, and I think it'll demonstrate the effectiveness that Opsalur really provides to these patients.

Hum.

So yes, we expect all of the agreements that I discussed the third P. B M coming on board this year.

And then the mtc blocks removing for all of the Pbms This year.

So that's what our expectation is kind of can the eczema.

I think it is an opportunity for us it's a severe disease thats difficult to handle and I think it will demonstrate the effectiveness that absolutely are really provides to these patients yeah, just maybe a little more color on that thanks Barry.

Speaker 5: Just maybe a little more color on that, thanks Barry. Obviously it's within label to treat any part of the body as Barry set up front. Although there's a very distinct clinical entity where patients can get severe involvement of their hands only. And there's a contact aspect to that in terms of contact dermatitis in the hands. And you've seen it become quite prevalent.

Obviously, it's it's within label to treat any part of the body is as Barry said upfront, although there's a very distinct clinical entity, where where patients can get severe involvement of their hands only and there is a contact aspect to that in terms of contact dermatitis.

And the hands and you've seen it become quite prevalent.

Speaker 5: during the pandemic, during COVID with people and particularly physicians and other healthcare providers wearing gloves.

During the pandemic during COVID-19 with people and particularly physicians and other health care providers wearing gloves, where you see a lot more hand eczema. So the idea is that a separate opportunity.

Speaker 5: where you see a lot more hand eczema. So the idea is that the separate opportunity gets addressed as a standalone indication that we generate robust clinical data. We expect the study to enroll through this calendar year, 2022, and then.

Gets addressed as a stand alone indication that we generate robust clinical data. We expect the study to enroll through this calendar year 2022, and then have data for you in 2023, and that's the premise behind studying that condition.

Speaker 5: have data for you in 2023. And that's the premise behind studying that condition.

Speaker 1: Thank you. Our next question is coming from Creepa de Veraconda from Trua Security. Your line is now live.

Thank you. Our next question is coming from Cooper, Dave Eric Handler from <unk> Securities. Your line is now live.

Hey, guys. Good morning. Thank you so much for taking my question.

A question about the guidance for Jakafi, the midpoint guidance implied year over year growth, but it's.

It's sort of flattish for Q1 middle of 2021, you talked about.

Are you going to implement and.

And you did you did on the strong recovery in the second half of 2021.

Speaker 15: I was wondering if there are any metrics or any implementations that you did in the second half that you can expect to leverage.

I was wondering is there any metrics or any implementations that you did in the second half that you can expect leverage in.

Speaker 15: in this year to provide additional growth with Jacify. And also in that vein, can you maybe talk about your level of comfort of as a long-term guidance you gave for Jacify?

This year to provide additional growth.

With Jakafi and also in that vein can you maybe.

Talk about your level of comfort with the long term guidance you gave for <unk>.

Jakafi. Thank you.

Speaker 6: So let me start, and Barry can add here, but when you look at the 2022 guidance range that we provided for Jakafis 2.3 to 2.4, so if you look at the high end of the range, it implies a 12% year-over-year growth, or in dollar terms, incremental revenues of 265 million relative

So let me start and and Barry can add here, but when you look at two.

2022 guidance range that we provided for Jakafi to $3 2.4. So if you look at the high end of the range. It implies a 12% year over year growth or in dollar terms to incremental revenues of 265 media relative to 2021. So.

Speaker 6: to 2021. So that level of incremental

That level of incremental.

Speaker 6: revenue growth is very much in line with the growth we've been seeing pre-pandemic and that reflects and assumes

Revenue growth is very much in line with the growth we've been seeing pre pandemic and that reflects an assumed.

Continued growth across all indications and especially Gvhd, where we have the most recent approval for chronic gvhd use.

Speaker 6: continued growth across all indications, and especially GVHD, where we have the most recent approval for chronic GVHD.

Speaker 6: The low end of the range reflects the uncertainty around COVID-19 and how this may play out in the year, but that's how, what is really reflected by the two ends of the range.

The low end of the range reflects the uncertainty around COVID-19, and how this may play out that E S.

And in the ear, but but that's.

That's our that's how what is really a reflected by the two ends of the range.

Speaker 4: Yeah, and just stay out to it. I mean, we're very happy with the new patient's starts, actually.

Yeah, and just to add to it I mean, we're very happy with the new patient starts are actually.

Speaker 4: that recovered throughout 2021, especially in Q4. Obviously, the chronic GVHD launch is a big factor in that, and even the benefit for patients with chronic GVHD as sort of a halo effect over the rest of the indications.

That recover throughout 2021, and especially in Q4, obviously, the chronic gvhd launches big factor in that and even the benefit for patients with chronic gvhd is sort of a halo effect over the.

The rest of the indications so as Christiana said the low end of guidance is simply the uncertainty over COVID-19 , where last year, we thought things.

Speaker 4: So as Christiana said, the low end of guidance is simply the uncertainty over COVID. You know, last year we thought things were getting better in the summer, and moving into the fall, and then we had Omicron hit. And so we're fully expecting to have a good COVID-free, hopefully, year coming forward so that patients do not stay away.

Things were getting better in the summer and moving into the fall and then we had omicron hit and so.

We're fully expecting to have a good Kobe COVID-19 free hopefully year coming forward, so that patients do not stay away.

Speaker 4: uh... and that uh... uh... are uh...

And that.

A R.

Speaker 4: Field force can have access to the offices, which oncology offices tend to close down. But...

Field force can have access to the offices, which oncology offices tend to close down but.

Speaker 4: As far as what's happening with the rest of the indications for jackifier, as I said, chronic TBHD going very well, mild fibrosis patients, in fact we believe that physicians are starting mild fibrosis patients earlier now just because of the survival benefit that jackifier offers to NF patients. PV patients are staying at the duration of therapy continues to increase.

As far as what's happening with the rest of the indications for Jakafi as I said chronic gvhd growing very well myelofibrosis patients. In fact, we believe that our physicians are starting myelofibrosis fibrosis patients earlier now.

Just because of the survival benefit that Jakafi offers to MF patients PV patients are staying at the duration of therapy continues to increase so we hope we expect that the MF PV and gvhd.

Speaker 4: So we hope, we expect, that the MFPD and GVHD growth will continue. The high growth of GVHD in the fourth quarter, obviously, was a little affected by the patients on our Expanded Access Program that gets switched over to commercial. But nevertheless, we fully expect Jackify to continue to be the standard of care in serodiffractory acute and chronic GVHD. And of course, it's life-saving, potentially.

Growth will continue.

High growth of Gvhd in the fourth quarter, obviously, it was a little affected by the extended their patients on our expanded access program that gets switched over to commercial but nevertheless, we fully expect our jakafi to continue to be the standard of care in steroid refractory acute and chronic gvhd and of course, it's a life saving potentially.

Speaker 4: can extend life for myelophybrosis patients and provide a great quality of life, a better quality of life for patients with polycythemia there.

Can extend life for myelofibrosis patients and provide a great quality of life, a better quality of life for patients with Polycythemia Vera.

Speaker 3: For the long-term guidance, the long-term guidance, we are...

Therefore, the long term guidance long term guidance we are.

Speaker 3: know, very much in line. I mean, this is getting closer and closer. And if you remember, the long-term guidance applies to the franchise. So it would, in the situation where we would have new products being launched in the next few years, it will be included in the $3 billion guidance we give.

Very much in line I mean this is a is.

Is giving them.

And if you remember the long term guidance supplies to the French size. So it would be in the situation, where we would have new products being launched.

In the next few years it will be it's included in the 3 billion. The guidance. We gave you the best.

Okay, and if I can ask the pipeline question I know you recently opted out of the PD 137, PD Lone Bispecific, we still see collaboration candidate multiple Io candidates listed as part of your pipeline.

Speaker 15: And if I can ask a pipeline question, I know you recently opted out of the CD137 PD-L1 by specific, but we still see collaboration candidates, you know, multiple IOC.

Is there an expectation to provide.

Speaker 15: big picture strategy on how you plan to develop the I.O. platform this year at some point.

Pick your strategy on how you how you plan to develop the IL.

Platform this year at some point.

Yes, Chris it's Steven.

Speaker 5: The equipment's even, you know, whether we conduct an R&D day or not, you know, we'll wait to tell you on that I'm not sure we've decided. Just, you know, in terms of the IO platform, as we alluded to in the prepared remarks.

Whether we conduct an R&D day not to know we'll wait to tell you on that I'm not sure. We've decided just in terms of the Io platform as we alluded to in the prepared remarks.

Speaker 5: You know, the oral PD-L1 program is at a very exciting stage of development. We have, you know, three products in the clinic, all of whom have shown clinical activity. The two other products behind 5-5-0 have no peripheral neuropathy, and we want to make further decisions this year.

The oral PD Lone program is at a very exciting stage of development.

We have three products in the clinic, all of whom have shown clinical activity. The two other products behind five five <unk> have no peripheral neuropathy and we want to make further decisions this year.

Speaker 5: We also have an exciting adenosine program both a small molecule A2B antagonist, and a CD73 antibody, which is also going through the connector here, and then our lag three program.

We also have an exciting <unk> program, both the small molecule <unk> antagonist NFC. The 73 antibody, which is also going through the clinic. This year and then our lag three program.

Speaker 12: The field has been sort of reignited beyond Checkpoint alone now with data on lag, Tidgit and potentially Tim3 as well, and there'll be some moving targets, and we'll give more clinical plans when we're ready to share them. But we have a very healthy IO pipeline, we're positioned in all those areas well, and stay tuned on the oral PD-L1. I'll just leave it at that. Great. Thank you.

The field has been sort of reignited beyond checkpoint alone now with data on lag.

Tidjane and potentially Tim three as well and there'll be some moving targets and we'll give more clinical plans when we're ready to share them, but we are we have a very healthy Io pipeline, we positioned in all those areas are well and stay tuned on the oral PDL one I'll just leave it at that.

Great. Thank you so much.

Thank you our final question today is coming from Latin America.

From Evercore ISI. Your line is now live.

Hey, Thanks for taking the question.

Speaker 16: Great, thanks for taking the question. Just to follow up on one of the prior OpsAurora questions, in your discussions with payers so far, are you seeing requirements for step-through more than just topical steroids? In some of the prior ops that we found, it looks like some plans are requiring a second agent as well, but just curious what you're seeing more broadly. And then just to clarify for the 17% and other deductions, what are those and do you expect those going forward in the coming quarters?

Follow up on one of the prior outlook.

In your discussions with Payors. So far are you seeing requirement for step through more than just topical steroids in some of the power that we found it looked like some plans are requiring a second agent as well, but just curious what you're seeing more broadly and then just to clarify for the 17% and other deductions what are those.

And going forward.

<unk> quarters.

Speaker 4: Sure, as far as step 30 therapies go, they vary. Like I said, there's millions of patients that have been treated already with toposteroid, calcium urinin inhibitors. They'll continue, some will have one step, some of those two steps, some will just be two topical therapies, which may be a low potency steroid and a high potency steroid.

Sure as far as step therapies go they they're very like I said theres millions of patients that have been treated already with the topical steroids are casting urine inhibitors. Although continue some will have one steps some of that two step some of them will just be too topical therapies, which might be a low potency steroid.

And a high potency steroid.

Speaker 6: The other part of the question. Yes, I can take the second part. In terms of the 70%, there you have other discounts and fees, distribution of fees and related discounts that we may be providing, as well as the co-pay assistance for that packet as well.

The other part of the question, Yes, I can take in the second act in terms of the 70%. There you have either discounts and fees distribution fees and related discounts. So that we may be providing as well us says they are.

Co pay assistance folks out there that bucket that's worth.

Okay.

Thank you we've reached end of our question and answer session I would like to turn the floor back over to Christine for any further closing comments.

Speaker 1: Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Christine for any further.

Thank you all for participating in the call today and for your question, Greg and I will be available for the rest of the day for follow ups. Thank you and goodbye.

Speaker 2: Thank you all for participating in the call today and for your questions. Greg and I will be available for the rest of the day for follow-up. Thank you and goodbye.

Speaker 1: Thank you. That does include today's telecompersons webcast, you may just connect your line. At this time, I'm gonna have a wonderful day. We thank you for your-

Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.