Q1 2022 Incyte Corp Earnings Call

Operator: Hello, and welcome to the Incyte First Quarter 2022 Earnings Conference Calling Webcast. At this time, all participants are in a listen-only mode.

Hello, and welcome to the insight first quarter 2022 earnings conference call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.

Operator: A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone, As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Christine Cho, Head of Investor Relations. Please go ahead.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded it's now my pleasure to turn the call over to Christine Cho head of Investor Relations. Please go ahead.

Christine Cho: Thank you, Kevin. Good morning and welcome to Incyte's first quarter 2022 earnings conference call and webcast. The slides presented today are available for download on the investor section of our website. Joining me on the call today are Herve, Barry, Steven, and Christiana, who will deliver a prepared remark, and Dash, who will join us for the Q&A. 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 Irving.

Thank you Kevin Good morning, and welcome to insights first quarter 2022 earnings conference call and webcast. The slides presented today are available for download on the investors section of our website joining.

Joining me on the call today are vey, Barry Steven and Christiana, who will deliver our prepared remarks and dash will join us for the Q&A.

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.

Irving: Thank you, Christine, and good morning, everyone. Incyte's strong momentum in 2021 continued into the first quarter with product and royalty revenues up 20%. Jacka Fye grew 17% year over year with patient demand driving growth in MF and PV as well as in GVHD, following the successful launch and the chronic indication. Our hematology and oncology portfolio grew 24% year-over-year, driven by our new product uptake, consisting of multiple new launches, including Pemazir in Europe and Japan, and Minjuvi in Europe.

Thank you Christine and good morning, everyone.

In fact strong momentum in 2020, one continued into the first quarter with product and royalty revenues up 20%.

Jakafi grew 17% yoga with patient demand driving growth in MF and PV as well as in Gvhd.

Following the successful launches of a chronic indication.

How will it matter of G. M oncology portfolio grew 20 photo fans yoga yeah.

But yeah, well new product uptake.

Think of multiple new launches, including Vimizim in Europe and Japan.

In Europe .

Irving: The Optelora launch continues to be very successful, with strong uptake by dermatologists. High satisfaction reported by both patients and physicians, and significant advancement with payers, which Barry will address in his, We made progress across all stages of our pipeline, with important updates that include positive 52-week data for ROXALY-Tinib cream in VT-LIGO. The Privatization of 280 and 318, in our Oral PD-L1 program and the start of our CDK-2 clinical program. Our royalty revenue remains strong, growing 23% year-over-year, contributing to our gross profit. Turning to slide 5.

So there's a lot of launch continued to be very successful with strong uptick by dermatologists.

Besides the spectrum that we bought it by both patients and physicians and significant advancements with <unk>, which Barry will address in his remarks.

We made progress across all stages of our pipeline with important updates that include because it at 52 week data for rux cream in vitiligo.

So privatization of two eight and 318.

He had one program and the startup of our two clinical programs.

Our royalty revenue remained strong growing 23% yoga Europe contributing to our gross profit.

Turning to slide five.

Irving: As you can see on the left, we are still in the early phase of launch for many of these products, including Obzellua in Atopic Dermatitis, Pemazir in Cholangiocarcinoma, where we are expanding geographically, and Min Zhuvi, which is just starting to launch in Europe, and Jacka Fye, where we recently launched in Chronic GVHD in the US. There is ample room for growth with each of these new launches. On top of that, we have new potential indications, that will be providing additional growth opportunities with Obsteroa and VT-LiGO, and with our partner product where we have new indications being planned over the next few months for Alumion, Tabrekta and Jacket, in addition to these launches.

As you can see on the left we are still in the early phase of launch for many of these products, including up their ROI and that the big dermatitis. They measure in Cholangiocarcinoma, where we are expanding geographically.

And means review, which is just starting to launch in Europe , and Jakafi, where we have recently launched in chronic gvhd in the U S.

There is ample room for growth with each of these new launches.

On top of that we have new potential indication.

We'll be providing additional growth opportunities with upside why do they go.

And with our partner product, where we have new indications being planned over the next few months for them to break that into equity.

In addition to these launches.

Irving: There are a number of programs in our mid- and late-stage pipeline, as shown on the right, that could have a meaningful impact on our revenue. Before handling the call to Barry, I would like to provide an update on Observer Manufacturing. We have recently received FDA approval and have implemented a new manufacturing process to improve the dissolution of API for Opdelora. In addition.

There are a number of programs in our mid and late stage pipeline as shown on the right that could have a meaningful impact on our revenue.

Before handing the call to Barry I would like to provide an in depth unabsorbed manufacturing.

We have recently received the FDA approval and have implemented a new manufacturing process to improve the dissolution of a P. I felt at all.

In addition, consistent with best practices, we have received FDA approval for its still going to manufacture of upsell ought to see book that will successfully launch.

Irving: Consistent with best practices, we have received FDA approval for a second manufacturer of Obstellura to support our successful launch. We are also preparing to reintroduce samples in the U.S. Now to share more details on product performance and outlook, I will turn the call over to Barry. Thank you, Herve. Good morning, everyone.

We're also preparing to introduce samples in the U S.

Now to share more details on product performance and outlook I will turn the call over to Barry.

Thank you Ravi and good morning, everyone.

Barry: The launch of OxyLora in the U.S. is off to an excellent start, with over 68,000 total prescriptions written through the end of the first quarter. More than 38,000 new patients were treated in the first quarter, bringing the total number of new patients treated with Opsalora to over 57,000 since launch. We attribute the robust uptake and the very high satisfaction of both patients and physicians, which is fueling the positive feedback loop and driving demand. Patients are requesting refills, which accounted for roughly 23% of prescriptions in the last week of Q1, another good indicator of long-term growth potential for Opsalora.

The launch of <unk> in the U S is off to an excellent start with over 68000 total prescriptions written through the end of the first quarter more than 38000, new patients were treated in the first quarter, bringing the total number of new patients treated with absolute over 57000 since launch.

We attribute the road robust uptake in the very high satisfaction of both patients and physicians, which is fueling a positive feedback loop and driving demand.

Once that requesting retails, which accounted for roughly 23%.

Percent of prescriptions in the last week of Q1, another good indicator at long term growth potential for oxo Laura on the payer front, we have added coverage of over 75 million additional lives since the end of January . This brings the total number of covered lives to $146 million higher.

Barry: On the payer front, we have added coverage of over 75 million additional lives since the end of January. This brings the total number of covered lives to 146 million, highlighting the progress we have and continue to make in the early months of launch. Turning to slide eight.

Writing the progress we have and continue to make in the early months of launch.

Turning to slide eight.

Barry: Multiple leading indicators are supporting the long-term potential of the Opsalora, including market share gains for new patients and positive feedback on patient experience. In just six months since launch, our 12% new patient share now exceeds that of Eucritha and Dupixent, highlighting the unmet need for more efficacious treatments for atopic dermatitis patients. Over 7,500 physicians have now prescribed Opsalora.

Multiple leading indicators are supporting the long term potential adopt to lora, including market share gains for new patients and positive feedback on patient experience in just six months since launch our 12% new patient share now exceeds that of you Christa and depicts it highlighting the unmet need for more efficacy.

<unk> treatments for atopic dermatitis patients.

Over 7500 physicians have now prescribed absolutely we continue to increase our prescriber depth week over week, gaining an average of 200 to 300, new writers each week, our high decile prescribers, those who see the highest volume of 80 patients each week and who have written a script.

Barry: We continue to increase our prescriber depth week over week, gaining an average of 200 to 300 new writers each week. Our high-decile prescribers, those who see the highest volume of AD patients each week, and who have written the scripts for Opsalora, have initiated an average of 18 new patients of Opsalora since launch. This repeat prescribing shows the positive experience and confidence that physicians are having with Opsalora and is supported by recent market research from the field.

Absolutely I have initiated an average of 18, new patients adopt a lora since launch.

This repeat prescribing shows a positive experience and confidence that physicians are having with absolute era and is supported by recent market research from the field. We are receiving very favorable feedback from the physicians about the efficacy of absolute are resulting in a high rate of satisfaction among both patients and physicians in a recent.

Barry: We are receiving very favorable feedback from the physicians about the efficacy of Opsalora resulting in a high rate of satisfaction among both patients and physicians. In a recent survey, over half of physicians indicated they expect to increase prescribing of Opsalora in the next three months, with over 60% of our top dermatologists indicating that Opsalora will more than double in the coming months. Moving on to our progress. Payers on St. John's.

Survey over half that of the us.

Physicians indicated they expect to increase prescribing it absolutely in the next three months with over 60% of our top dermatologist, indicating.

Absolutely.

More than double in the coming months.

Moving on to our progress with payers on <unk>.

Barry: Since our last update, we were able to get NDC blocks removed with one national PBM. One large national health plan and multiple key regional plans, adding approximately 53 million commercial lives, which are now covered including our progress with Medicaid and government channels. Our total number of lives covered has increased by 75 million to reach 146 million which is outstanding progress in the short amount of time. As a final note on Opsalora, we are also preparing to reintroduce samples in the United States. Turning to slide 10 and Jackify Performance.

Since our last update.

Earnings call, we were able to get N D. C blocks removed with one national P. P. M. One large national health plan and multiple key regional plans, adding approximately 53 million commercial lives.

Which are now covered including our progress with Medicaid and government channels. Our total number of lives covered has increased by $75 million to reach $146 million, which is outstanding progress in a short amount of time.

Yeah.

As a final note on absolute era, we are also preparing to reintroduce samples in the United States.

Barry: Jackify net sales in the first quarter grew 17% year-over-year to $544 million. Total patient demand grew across all indications, and the growth in new patient starts of 12% versus the first quarter of 2021 remains above pre-pandemic level. New patient starts in GBHD grew 25% year over year with strength coming from the launch in the chronic indication. With the strong demand for Jackify, we are raising the bottom end of our Jackify full year net product revenue guidance from $2.3 billion to a new range of $2.33 billion to $2.4 billion.

Turning to slide 10, and Jakafi performance Jakafi net sales in the first quarter grew 17% year over year to $544 million.

Total patient demand grew across all indications and the growth in new patient starts of 12% versus the first quarter of 2021 remains above pre pandemic levels, new patient starts and gvhd grew 25% year over year with strength strength coming.

From the launch in the chronic indication with.

With the strong demand for Jakafi, we are raising the bottom end of our Jakafi full year net product revenue guidance from $2 3 billion to a new range of $2 three 3 billion to $2 4 billion.

Barry: Turning to slide 11, Monjuvi net product sales in the U.S. grew 21% year-over-year to $19 million in the first quarter, and we are continuing to see uptake in new and existing accounts. More second line news and a gradual improvement in duration of therapy. Minjuvi net sales were $5 million, with the launch ongoing in Germany, and we continue to seek reimbursement in other countries.

Turning to slide 11 mine, Judy net product sales in the U S grew 21% year over year to $19 million in the first quarter and we are continuing to see uptake in new and existing accounts more second line use and a gradual improvement in duration of therapy.

<unk> net sales were $5 million with the launch ongoing in Germany, and we continue to seek reimbursement in other countries and <unk> grew 34% to $18 million with a duration of therapy continuing to drive this performance and with that I'll turn the call over to Steven.

Steven: Pemizer grew 34% to $18 million with the duration of therapy continuing to drive its performance, and with that, I'll turn the call over. Thanks, Barry, and good morning, everyone, starting with Ruxlydnivkrim on slide 13. Last month, we presented updated 52-week data for ruxolitinib cream in vitiligo at the American Academy of Dermatology annual meeting. As a reminder, during the 24-week double-blind period, patients were randomized 2-to-1 to receive Ruxlitinib cream, 1.5% BID, or Viacom.

Thanks, Barry and good morning, everyone.

Starting with <unk> cream on slide 13 last month, we presented updated 52 week data for <unk> cream in vitiligo at the American Academy of Dermatology annual meeting.

Steven: After the 24-week visit, all patients crossed over to active therapy. At 52 weeks, approximately 50% of the patients initially randomized to Ruxelidnib cream experienced at least a 75% improvement in their VASI score from baseline, and nearly one third of patients experienced at least a 90% improvement in facial vasculature. No new safety signals were seen and ruxolitinib cream was well-tolerated with no serious treatment-related adverse events reported.

As a reminder, during the 24 week double blind period patients were randomized two to one to receive <unk> lithium cream, one 5% PID or vehicle.

After the 24 week visit all patients crossed over to active therapy.

At 52 weeks approximately 50% of the patients initially randomized to rux lithium cream experienced at least a 75% improvement in their <unk> score from baseline.

And nearly one third of patients experienced at least a 90% improvement and facials assay.

No new safety signals were seen and racks lithium cream was well tolerated with no serious treatment related adverse events reported.

Steven: These data demonstrate the potential for substantial improvement in repigmentation with a longer duration of treatment with ruxolitinib cream. Also at AAD, we presented data from our population-based Valiant study, which aimed to better understand quality-of-life burden faced by people with vitiligo. In studies, anxiety and depression were reported in up to 68% and 62% of patients with vitiligo, respectively. The psychological impairment that may result from vitiligo can be similar to that of other skin diseases, such as psoriasis or eczema and can impact patients of all types, indiscriminate of skin color, percentage body surface area involvement or the area affected.

These data demonstrate the potential for substantial improvement in re pigmentation with a longer duration of treatment with rux cream.

Also at AAD, we presented data from a population based Valeant study, which aimed to better understand quality of life burden faced by people with vitiligo.

In studies anxiety and depression were reported in up to 68% and 62% of patients with vitiligo respectively.

The psychological impairment that May result from vitiligo can be similar to that of other skin diseases, such as psoriasis or eczema and can impact patients of all types indiscriminate of skin color percentage body surface area involvement or the area affected.

Steven: Many patients of the vitiligo have stopped seeking treatment due to a lack of approved therapy. We are excited at the potential to bring the first FDA approved therapy for repigmentation to people with vitiligo and to be able to offer them a new choice of therapy. Ruxolidinib cream is under review, both in the United States and in Europe, with a PDUFA date in the United States of July 18, Moving to slide 15. We are initiating a study in vitiligo to evaluate the benefit of adding phototherapy to ruxolidinib cream treatment.

Many patients with vitiligo, if stop seeking treatment due to a lack of approved therapies.

We are excited at the potential to bring the first FDA approved therapy for re pigmentation, two people with vitiligo and to be able to offer them a new choice of therapy.

Lithium previous under review, both in United States and in Europe , with a <unk> date in the United States of July 18th.

Moving to slide 15, we are initiating the study in vitiligo to evaluate the benefit of adding photo therapy to <unk> cream treatment.

Steven: This is a 48-week trial where patients will receive 1.5% Ruxelin lip cream twice daily for 12 weeks followed by Ruxelin lip cream plus or minus phototherapy, Rounding out dermatology, INCB 54707 is in Phase 2 studies for vitiligo, hyaluronidus suprativa, and purigo nodularis, where there continues to be high unmet medical need and a lack of effective therapies, or in some cases, no approved therapies at all. We expect to present data for vitiligo and higher adenitis supertiva in the second half of this year.

This is a 48 week trial, where patients will receive one 5% <unk> cream twice daily for 12 weeks, followed by our excellent cream plus or minus phototherapy.

Rounding out dermatology Incb 54707 is in phase III studies for vitiligo, Hidradenitis, Suppurativa and Piragua, not Dolores where there continues to be high unmet medical need and a lack of effective therapies or in some cases no approved therapies at all.

We expect to present data for vitiligo and higher Ed not as Super Teva in the second half of this year.

Steven: Turning to slide 17 and our oral PD-L1 program. Last year at CITSE, we presented data on the three compounds in our oral PD-L1 program, where we demonstrated the first clinical activity with an oral PD-L1 inhibitor. We saw evidence of tumor shrinkage with all three compounds, and in the case of H6550, an increased rate of peripheral neuropathy, Based on clinical data from ongoing studies and positive therapeutic ratios seen for 280 and 318, we have opted to move forward with these two compounds.

Turning to slide 17, and our oral PD Lone program.

Last year at <unk>, we presented data on the three compounds in all our own PD Lone program, where we demonstrated the first clinical activity with an oral PD lone inhibitor.

We saw evidence of tumor shrinkage with all three compounds and in the case of 80 6550, an increase rate of peripheral neuropathy.

Based on clinical data from ongoing studies and positive therapeutic ratio seen 4280, and 318, we have opted to move forward with these two compounds.

Steven: Enrollment is progressing well in both studies with 280 and 318. We continue to observe tumor shrinkage with both compounds, and to date, no evidence of peripheral neuropathy has been seen. There are several benefits to an oral PD-L1, including the potential for better management of immune-related adverse events due to a shorter half-life, the opportunity of developing oral-oral combinations, and the ease of dosing with an oral agent.

Enrollment is progressing well in both studies with two <unk> and 318, we continue to observe tumor shrinkage with both compounds and to date no evidence of peripheral neuropathy has been seen.

There are several benefits to an oral PDL, one, including the potential for better management of immune related adverse events due to a shorter half life the opportunity of developing oral oral combinations and the ease of dosing with an oral agent.

Steven: We expect to provide a data update from our RO-PD-L1 program in the second half of this year. Moving to early development on slide 18. We are initiating a phase 1 dose escalation and dose expansion study in advanced solid tumors with our novel, potent, and selective oral small molecule CDK2 inhibitor, INCB123667, CDK2, in complex with cyclin E, is a cell cycle regulator which, when inhibited, has been shown to suppress tumor growth, mainly in cyclin E amplified tumor models, SACLIN-E is an amplified oncogene in multiple aggressive cancer types, including ovarian and endometrial cancer.

We expect to provide a data update from our oral PD Lone program in the second half of this year.

Moving to early development on slide 18.

We are initiating a phase one dose escalation and dose expansion study in advanced solid tumors with our novel potent and selective oral small molecule CDK <unk> inhibitor <unk> 3667 <unk>.

CDK too and complex with Cyclin E is a sales cycle regulator, which went inhibitor has been shown to suppress tumor growth mainly in cyclin E amplified tumor models.

And he's an amplified oncogene in multiple aggressive cancer types, including ovarian and endometrial cancer.

Steven: To close, we expect multiple regulatory and key clinical data readouts this year, as shown on slide 19. Specifically for Limber, the Once Daily Rucks NDA will be submitted in this half of 2022. The BETT and ELK2 combination trials with ruxolitinib are progressing well, with data expected in the second half of 2021, the Raxalym Cream Producer for Vitiligo in the United States is July 18, 2019, and we expect an EMA decision in the second half of this year as well.

To close we expect multiple regulatory and key clinical data Readouts. This year as shown on slide 19.

Specifically for Linda the once daily Rux NDA will be submitted in this half of 2022.

The bet and <unk> two combination trials with <unk> are progressing well with data expected in the second half of 2020 to the.

<unk> cream producer for a little bit of lager in the United States is July 18th and we expect an EMA decision in the second half of this year as well.

Steven: For our partnered products, Raxolidinib in acute and chronic graft-versus-host, and Kat Matnab in non-small cell lung cancer, both have received positive CHMP opinions. With that, I would like to turn the call over to Christiana for the financial update. Thank you, Steven. And good morning, everyone. Our first quarter results reflect continued strong revenue growth with total products and royalty revenues of $728 million, representing an increase of 20% over the first quarter of 2021, and reflecting growth across products commercialized by Incyte and Incyte Discover products commercialized by our partners. Total product and royalty revenues for the quarter are comprised of net product revenues of $544 million for Jacka Fye.

For our partnered products <unk> been acute and chronic graft versus host disease and <unk> in non small cell lung cancer. Both have received positive CH M. P opinions.

With that I would like to turn the call over to Christiana for the financial update.

Christiana: $49 million for other hematology-oncology products. $13,000,000 for Opselura, Royalties from Novartis of $71 million for Jacardi and $3 million for Tabrekta and royalties from Lilly of $48 million for Oluwadamil. Turning to Opsalura, in the first quarter, the growth in prescriptions continued to be strong, leading to gross product sales of $90 million for the quarter. As payers add Opsalura to formularies, we are starting to see the improvement in the gross-to-net discount rate. The fully loaded gross-to-net discount rate decreased from 92% in the fourth quarter of 2021 to 86% in the first quarter of 2022, leading to net product sales for the quarter of $13 million.

Thank you Susan and good morning, everyone. Our first quarter results reflect continued strong revenue growth with total product and royalty revenues of $728 million, representing an increase of 20% over the first quarter of 2021, and reflecting growth across products commercialized by inside and then.

<unk> discover products commercialized by our partners.

Total product and royalty revenues for the quarter and comprised of net product revenues of $544 million for Jakafi.

$9 million for other hematology oncology products and $13 million for upsell ramp right.

Probably at least from Novartis of $71 million for Jakafi and $3 million for tap rector and royalties from Lilly a $48 million for Illumina.

Turning to upsell all that in the first quarter as the growth in prescriptions continued to be strong leading to gross product sales of $90 million for the quarter.

As payers had alluded to formularies, we are starting to see the improvement in the gross to net discount rate.

The fully loaded gross to net discount rate decreased from 92% in the fourth quarter of 2021% to 86% in the first quarter of 2022, leading to net product sales for the quarter of $13 million.

Christiana: On our Q4 call earlier this year, we showed you our forecast of the evolution of the gross-to-net discount rate as the peak, by the Dotted Blue Line. The green line represents our actual gross net discount and as you can see Q1 was very much, We expect the gross-to-net discount rate to continue to decline in Q2 and normalize at a fully loaded rate of 40-50% between Q3 and Q4, depending on the timing of the removal of the remaining NDC blocks by PBMs and the addition of obsolura on formularies.

On our Q4 call earlier this year, we showed you a forecast of the evolution of the gross to net discount rate as depicted by the Blue line.

The Green line represents our actual gross to net discount and thus you can see Q1 it was very much on track.

We expect the gross to net discount rate to continue to decline in Q2 and normalize at the fully loaded rate of 40% to 50% between Q3 and Q4, depending on the timing of the removal of the remaining and discipline slightly BMS and the addition of upsell around formularies.

Christiana: Moving on to our operating expenses on a gap basis. Ongoing R&D expenses of $333 million for the first quarter decreased 13% from the prior year period, primarily due to increased 13% from the prior year period, primarily due to the continued investment in our late stage development. Total R&D expense of $353 million for the first quarter includes milestone consideration of $20 million for our collaborative agreement. SG&A expense for the first quarter of $210 million increased 36% from the prior year period's total SG&A expense, or 49%, excluding the $13 million one-time payment recorded in the first quarter of 2021.

Moving on to our operating expenses on a GAAP basis ongoing R&D expenses of $333 million for the first quarter decreased 13% from the prior year period, primarily due to increased 13% from the prior year period, primarily due to the let's say continue to invest.

In our late stage development asset.

Total R&D expense of $353 million for the first quarter includes milestone consideration of $20 million for our collaborative agreements.

SG&A expense for the first quarter of $210 million increased 36% from the prior year period, total SG&A expense or 49%, excluding the 13 million onetime payment recorded in the first quarter of 2021.

Christiana: The growth was primarily due to our investments related to the new dermatology commercial organization in the U.S. and the related activities to support the launch of Oxelwood. Our collaboration loss for the quarter was $5 million, which represents a 50% share of the U.S. net commercialization loss.

The growth was primarily due to our investments related to the new dermatology commercial organization in the U S and the related activities to support the launch of a kilometer.

Our collaboration loss for the quarter was $5 million, which represents a 50% share of the U S. Net commercialization of loss for my children.

Operator: Finally, our financial position continues to be strong as we ended the quarter with $2.5 billion in cash and market, Moving on to our guidance for 2022, as a result of our strong first quarter performance, as well as signs and expectations of sites reopening and providing us with increased access to physicians, we are tightening our Jacka Fye guidance range from $2.3 to $2.4 billion to a new range of $2.33 to $2.4 billion. We are also reaffirming our other hematology-oncology revenue, COGS, R&D, and SG&A guidance for the year. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

Finally, our financial position continues to be strong as we ended the quarter with two and a half million dollars in cash and marketable securities.

Moving onto our guidance for 2022 as a result of our strong first quarter performance as well as signs and expectations of sites reopening and providing us with increased access to physicians. We are tightening our jakafi guidance range from two three to $2 $4 billion to a new range of two <unk>.

33 to $2 $4 billion. We are also reaffirming our other hematology oncology revenue Cogs, R&D and SG&A guidance for the year.

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

Operator: Thank you and I'll be conducting a question and answer session. If you'd like to be placed into question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Thank you, we'll 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. It may be necessary to pick up your handset before pressing.

Operator: You may press star 2 if you'd like to remove your question. Participants using speaker equipment it may be necessary to pick up your handset before pressing star one one moment, please while we pull from, Our first question today is... From Morgan Stanley, your line is now live. Great, good morning. Thanks for taking my questions. So I had a few on Opsalura.

Star One one moment, please while we poll for questions. Our first question today is coming from Brooklyn, Kuri from Morgan Stanley . Your line is now live.

Steve: First, could you speak a bit more about the manufacturing update you began the call with? Specifically, at this point, how many batches or what portion of the current commercial supply do you estimate has been impacted by some of the texture issues that you mentioned previously? And for the updated manufacturing process, what is the current thinking around the timeline for getting that up and running? And how long do you think it'll be before the sampling program can be reinstated?

Great. Good morning, Thanks for taking my questions. So I had a few on obsolete.

First could you speak a bit more about the manufacturing update you began to call with specifically at this point, how many batches or what portion of the current commercial supply do you estimate has been impacted by some of the texture issues that you mentioned previously and for the updated manufacturing process.

What is the current thinking around the timeline for getting that up and running and how long do you think it'll be before the sampling program can be reinstated.

I had a follow up but.

Maybe I'll ask you those questions first.

Okay.

Steve: And then I had a follow up, but maybe I'll ask you those questions first. Vikram, hi, it's Steve, and I'll take your question, and I'll just reaffirm some things we said on the actual prepared remarks, and just to reiterate, we know that the texture issue is due to a very small amount of active pharmaceutical ingredient that has come out of solution, and that has obviously been the focus of all our efforts.

Vikram Hi, it's Steven I'll I'll take your question and I'll just reaffirm some things we said on the actual prepared remarks.

Just to reiterate we know that the the texture issues due to a very small amount of active pharmaceutical ingredient that has come out of solution and that has obviously been the focus of all our assets you know as everybody said upfront we have implemented a recent process change by a regulatory process called a CBE 30.

Steve: You know, as Herve said up front, we have implemented a recent process change via a regulatory process called a CBE-30 that improves solubility. We've received FDA approval for this, and that process is underway and is improving the dissolution of API. In addition, as Herve said on his prepared remarks, via a longer regulatory process called a prior approval supplement, and as is best practice, we've initiated a second manufacturing site, and that is coming on board as we speak to answer your questions specifically.

That improved Tolerability, we've received FDA approval for <unk> for this and that process is underway and is improving the distribution of API. In addition, as I said on his prepared remarks via a longer regulatory process called a prior approval supplement and as these best practice, we've initiated a second manufacturing site.

And that is coming onboard as we speak to answer your question specifically so those units from that second sight will in the next couple of weeks, we'll be out in the field and with patients.

Steve: So those units from that second site will, in the next couple of weeks, will be out in the field and with patients. We absolutely, you know, expect also within the next week or so, as Barry said in his remarks, to begin the sampling program as well, given that now we have a batch made for that. We don't give specific numbers on percentages, but as, you know, we have already said in the call, 68,000 prescriptions with a very small amount of complaints, the rate is obviously coming down, and we expect it to do so now with these improvements as well going forward. Okay, got it.

We absolutely expect also within the next week or so as Barry said in his remarks to begin the sampling program as well.

Given that now we have a batch made for that.

We don't give specific numbers on percentages, but as you know we have already said in the call 68000 prescriptions with a very small amount of complaints that the rate is obviously coming down and we expect it to do so now with these improvements as well going forward.

Steve: That's helpful. And then as a follow up for vitiligo, assuming FDA approval in July, would you anticipate providing US sales guidance for vitiligo the way you have for AD? And more generally, as you've evaluated the opportunity in vitiligo over recent months, how do you think the commercial opportunity compares to what you're seeing now evolve in AD? So Vikram, hi, it's Christiana.

Okay got it.

That's helpful.

And then as a follow up for vitiligo, assuming FDA approval in July when do you anticipate providing U S sales guidance for.

Forbid a likelihood that way you have for a D and more generally as you've evaluated the opportunity in vitiligo over recent months, how do you think the commercial opportunity compares to what you're seeing now evolved in a D.

So I think I'm a high school you see on that in terms of like a peak sales potential.

Christiana: In terms of the vitiligo or pig sales potential, I think it's a little bit of a different situation than AD. In the AD, AD is an established market where it was easier to have a sense of not only the size of patients that are affected by AD, but the number of patients that are actively seeking treatment today, and how this market looks like, and how it may evolve. In the case of vitiligo, as we have discussed in the past, there are no effective therapies now.

I think it's a little bit of a different situation that may be in the the aim is an established market where it was easier to have a sense of not only is it.

Size of patients that are affected by the fact that the number of patients that are actively seeking treatment today and how this market looks like and how it may evolve in.

In the case of vitiligo actually we have discussed in the past day or no effective therapy now and as a result.

Christiana: And as a result, the majority of patients are not currently seeking treatment. So it's a little bit harder to have right from the beginning a sense of how quickly that will change. And therefore, we may not be in a position from the beginning to give you the pig sales estimate that we did for AD.

And Ah patients at the majority of those patients who are not currently seeking treatment. So it's a little bit harder to have that right from the beginning essentially how quickly that will change and therefore, we may not be in a position from the beginning to give you a peak sales estimates that we have.

Did that for a day actually if you look at vitiligo and you run the numbers even for the current number of patients that seek treatment. You can said they see that you can very quickly get to a very big numbers like in the billion plus type numbers. So we want to see a bit more of houses.

Christiana: Actually, if you look at vitiligo and you run the numbers, even for the current number of patients that seek treatment, you can see that you can very quickly get to very big numbers, like in the billion-plus type of numbers. So we want to see a bit more of how this evolves before we come out with the pig sales potential for vitiligo. Okay. I understood.

Loss before we come out with that.

Peak sales potential for vitiligo.

Okay understood very helpful. Thank you.

Christiana: Very helpful. Thank you. Thank you. Our next question today is coming from Kripa Devarakinda from Truist Securities. Your line is now live.

Thank you. Our next question today is coming from creep of the Golar tundra from Jewish Securities. Your line is now live.

Alright. Thank you so much for taking my question.

Barry: I'm wondering now that you.., and this continues, especially given that, and for Absolute Ready. Drug is being adopted and moved through [inaudible] And you have a better.., of Duration of Therapy, and is there any gap? or you're seeing people refilling at pretty good prices. So Kripa, this is Barry.

I'm wondering now that Youre reinstating the sampling program.

Would this continue keeping one.

Especially given that you might need to use it for as long a period.

There's just atopic dermatitis.

We did see efficacy.

Or I can do that atopic dermatitis is that the drug is being adopted and the move to the launch do you have a better sense.

Observation authenticity and is there any gap between G suite or Youre seeing people recently at pretty good compliance rate. Thank you.

So Chris this is Barry so yes, when we initiate a re initiate the samples for a D. We anticipate we'll still have samples and continuous samples throughout the launch of vitiligo as far as duration of therapy. It's too early in the launch I mean, we've launched for six months now we see no pay.

Barry: So yes, when we initiate, re-initiate the samples for AD, we anticipate we'll still have samples and continue samples throughout the launch of vitiligo. As far as, you know, duration of therapy, it's too early in the launch. I mean, we've launched for six months now.

Barry: We see new patient growth continuing to accelerate. We see the refills at 23%. We think that's pretty good for right now. And so as far as duration of therapies, we don't know. As far as gaps between tubes, for example, we also don't know.

<unk> growth continuing to accelerate we see the refill is at 23% we think that's pretty good for right now.

So as far as duration of therapy. So we don't know as far as gaps between between tubes. For example, we also don't know we'd have to go back to the clinical trials to see exactly what are those patients date, but it may not be in the same the same in the real world for a duration of therapy. What we've said in the past of course is that.

Barry: We'd have to go back to the clinical trial to see exactly what those patients did, but it may not be the same in the real world for duration of therapy. What we've said in the past, of course, is that once we stabilize over a period of time, as we get into launch, we anticipate that patients will generally get three to four tubes of Opsalora per year for atopic dermatitis. If I can ask a quick follow- And what are the pills? [inaudible] The pills? and this is about the absolute race.

Hum once we stabilize over a period of time as we get into launch we anticipate that patients will generally get three to four tubes of absolute euro per year for a four for atopic dermatitis.

Great. Thank you I think if I can ask a quick follow up question.

One of the plc spoke you said that no consensus about it about obsolete right.

Barry: Broadly really good. This black box label may be affecting uptake in community settings. Is that true?

Broadly really good but the black box label, maybe affecting uptake in the community setting is that what youre seeing or is it.

Yeah.

Barry: is the use of the drug impacting how communities. You know, I can't say that community doctors are any different than academic doctors. In fact, you know, in dermatology, there's very, there's very big practices that treat many, many patients and their uptake of Opsalur. So our highest decile prescribers, for example, continue to use it. You know, they'll tell us sometimes that individual patients might have more questions about the black box, but they're very used to explaining black box or side effects or potential side effects that any drugs they use may have. So they're comfortable walking patients through that, but we really haven't seen it as a barrier. Thank you so much for taking the time.

It is the use of the drug.

Impacting community doctors are looking at it.

No I can't say that the community doctors are any different than academic doctors. In fact, you know in dermatology theres very theirs.

Very big practices that are treating many many patients and their uptake of obsolescence. So our highest decile prescribers for example, continuing to use it.

They'll tell us sometimes that are individual patients might have more questions about the black box, but they are very used to explaining a black box or side effects of potential side effects that are any drugs. They use may have so they're comfortable walking patients through that but we really haven't seen it as a barrier.

Great. Thank you so much for taking my questions.

Barry: Thank you. Next question is coming from Matthew Phipps from William Blair. Your line is now, Good morning, thanks for taking my questions.

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

Good morning, Thanks for taking my questions first on the podium three or four study following the recent FDA AD com, even though this trial does have a couple of U S sites, it's not really comparing where the band Labatt to the current standard of care in the U S. So I'm wondering if you've got FDA sign off on that trial design or if you'll have to make changes.

Steven: First, on the Podium 304 study, following the recent FDA adcom, even though this trial does have a couple of U.S. sites, it's not really comparing vertifanlamab to the current standard of care in the U.S., so wondering if you got FDA sign-off on that trial design or if you'll have to make changes based on kind of the FDA's pushback of lilycentilumab approach. And then second, at the time of the Monjuvi deal, you had mentioned longer-term upside was really from the potential Monjuvi-plus parseclusive.

Just on the kind of the Fda's pushback of Lilly.

Lilly's until I'm out of approach and then second at the time of the month UV deal you had mentioned longer term upside was really from the potential demand Judy plus parser close it.

Steven: So I assume given the recent FDA ODAC on PI3 kinases and the decision to withdraw the parts of inclusive NDA, that that option might be kind of gone now, but just wondering what it means for the top mine study and does the secondary OS endpoint, in the myelofibrosis combination studies become, you know, really important after that ODAC or does it? maybe not impact myelofibrosis as much. Matt, hi, it's Steven.

I assume given the recent FDA Kodak.

Be it through kind of this is that the decision to withdraw the parcel close of NDA that that option might be kind of gone now, but just wondering what it means for the top line study and the secondary OS endpoint in the Myelofibrosis combination studies become really important after that Kodak or does it maybe.

Maybe that impact myelofibrosis as much things.

Steven: Thank you for your question. So just for everybody else, Podium 304 is our IV checkpoint redepamlamab in non-small cell lung cancer. It's a replication, if you will, of the initial PEMBRA approval in that indication in that it's, you know, combination with chemotherapy versus checkpoint inhibitor alone. And as you point out, it's a global study with sites all over the world, including in the United States. So we think that is the central difference from the Lilly issue they had with their checkpoint inhibitor, where it was China-only data. So we have representation across Western Europe, Eastern Europe, Asia, and a small amount of U.S. sites.

Matt Hi, it's Steven Thank you for your question. So just for everybody else podium three or four is all IV checkpoint family Mab and in non small cell lung cancer. It's a replication. If you will of the initial timber approval in that indication in combination with chemotherapy.

Steven: So we think from a diversity of subject point of view, we're well covered with that. You know, the modeling of the studies exactly from a statistical point of view in keeping with what we're seeing in the initial PEMBRA approval in that indication that was discussed with regulators and, you know, feedback was given and aligned with them. So we feel we are in a completely different position to what was the central complaint against the Lilly submission with their checkpoint inhibitor in non-small cell lung cancer, given, you know, the diversity of our population across the world, the size of the study, replication of the statistics to achieve the same endpoints, which, again, wasn't exactly the case with the ODAC reference.

Checkpoint inhibitor alone and as you point out it's a global study with sites all over the world, including in the United States. So we think that is the central difference from the Lilly issue. They had with their checkpoint inhibitor, where it was China early data. So we have representation across our western Europe Eastern Europe .

Europe Asia, and a small amount of U S sites. So we think from a diversity of subject point of view, we well covered with that.

You know the modeling of the studies exactly from a statistical point of view are in keeping with what was seen in the initial pembury approval in that indication that was discussed with regulators and and feedback was given an aligned with them. So we feel.

We are in a completely different position to what was the central complaint against the Lilly submission with with their checkpoint inhibitor in non small cell lung cancer, given the diversity of our population across the world are the size of the study replication statistics.

To achieve the same endpoints, which again wasn't exactly the case with the with the Oh deck you reference.

Steven: For tafacitamab in combination with paraclysib, you know, we remain interested, despite some of the negative halo and PR3 delta inhibitors, for a number of reasons. Firstly, because, you know, we know this is a tremendously active doublet from work that Morphosis have done before with tafacitamab with idealisib, in that having upwards of 100% response rates. So we are absolutely, you know, continuing to look at our data in TopMind, which is ongoing across different disease segments, including lymphoma, including chronic lymphocytic leukemia. But you are right.

For temper sit them, having combination with pasta cliffs.

Main interested despite some of the negative Halo and <unk> Delta inhibitors for a number of reasons firstly because.

No. This is a tremendously active doublet from work that morphosis have done before with Tampa sit a mab with audio lesser and that have been upwards of 100% response rates. So we are absolutely continuing to look at our our data.

In in top of mind, which is ongoing across different disease.

<unk> segments, including lymphoma, including chronic lymphocytic leukemia, but you are right I mean, there isn't a large increase in the safety of Delta inhibitors, and it's something we'll have to consider very carefully before going forward with any biggest study. There are we hope in the second half of this year.

Steven: I mean, there is a large increase in the safety of delta inhibitors, and it's something we'll have to consider very carefully before going forward with any bigger study there. We hope in the second half of this year to have decent data sets for the different subgroups of the fuselage, B-cell lymphoma, low-grade lymphomas, chronic lymphocytic leukemia, with that doublet. And then we'll have to make decisions in keeping with the context you allude to.

To have decent datasets for the different subgroups of diffuse large b cell lymphoma, low grade lymphomas, chronic lymphocytic leukemia with that tablet and then we will have to make decisions in keeping with the context, you alluded to I'm glad you brought up the the myelofibrosis program because again its racks in combination.

Steven: I'm glad you also brought up the myelofibrosis program, because, again, it's RUX in combination with paraclysib in two different settings. So there's a first-line study, which is enrolling very well. You know, it's a goal enrollment of around 440 patients, and it's a very clean study in that it's RUX plus paraclysib versus RUX alone in that indication, with a SVR 35% decrease primary endpoint. So, you know, the differences, again, given the milieu you talk about with PI3 delta inhibitors, is that this is a randomized study at a different dose of a delta inhibitor. You know, there's no induction therapy.

With Pos simplicity being two different settings. So there's a first line study, which is enrolling very well and you know it's a.

Golar enrollment of at around 440 patients and it's very clean studying isn't that it's rux plus pasta closer versus rux alone in that indication with this S. V are 35% decrease primary endpoint. So you know the differences again, given the malaria you talk about with <unk> Delta inhibitors.

Is that this is a randomized study.

At a different dose of a delta inhibitor theres no induction therapy to standard constant dose. It's a defined treatment period. The studies were agreed to and signed off with with regulatory authorities and does has as you point out also the ability to capture overall survival. So we think.

Steven: It's a standard constant dose. It's a defined treatment period. The studies were agreed to and signed off with regulatory authorities and does have, as you point out, also the ability to capture overall survival. So we think we're well covered in that indication. The suboptimal study there is in about 220 patients, also enrolling very well, should complete next year. Different endpoints, again, a randomized study, and in capture, you know, primary endpoints as well as secondary endpoints that'll include safety.

We well covered in that indication. The suboptimal study there are isn't about 220 patients also enrolling very well should complete next year a different endpoints again, a randomized study in and capture you know primary endpoints as well as secondary endpoints that will include safety. So again.

Steven: So again, a different dose, and we think we're well covered there as well. But we're not immune to the fact that the road for delta inhibitors will be extremely safety-focused, as they should be. Thanks.

Dosing, we think we're well covered there as well, but we're not immune to the fact that they the road for Delta inhibitors will be extremely safety focused as they should be thanks.

Thanks.

Okay.

Leonid: Thank you. Thank you. Next question is coming from Brian Abrams from RBC Capital Markets. Your line is now live. Hey, thanks. This is Leonid on for Brian.

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

Barry: So thanks for providing all the growth-to-net color. I was just wondering if I could ask a little bit more on that. I guess in previous calls, you mentioned that you have levers to adjust growth-to-net on your end. So I'm curious, you know, if the improvements in growth-to-net are largely from better insurance coverage or if also you're adjusting any of the patient assistance programs. And I guess, you know, for how long and to what degree do you expect these patient co-pay assistances to last?

Hey, Thanks. This is a lean it on for Brian .

So thanks for providing all the gross to net color I'm just wondering if I can ask a little bit more on that I guess.

Previous calls you mentioned that you.

Do you have levers to adjust gross to net on your end. So I'm curious if the improvements and Christine are largely from better insurance coverage or fall. So you're adjusting any of the patient assistance programs and I guess for how long into what degree do you expect these patient co pay assistance as to last and then if I can just squeeze in one more.

Barry: And then if I can just squeeze in, one more, you know, have you had any sense that there might be patient and doc perceptions that because insurance isn't covering Upselder, that's actually limiting willingness to write scripts? And so I guess, when you see better coverage, are you expecting that there might be a script inflection as well for Upselder? So Leonid, it's Barry.

No.

You had any sense that there might be patient and dock perceptions that because insurance isn't covering up sell or that's actually limiting willingness to write scripts and so I guess when you see better coverage are you expecting that there might be a script inflection as well, perhaps helena. Thanks.

So then it.

Barry: So on the GrossDinet, so as we said, as we continue to get better coverage as the NDC blocks are removed, our GrossDinet, as Christiana said, is going to improve in the second quarter, in the third quarter, and in the fourth quarter. So we have 146 million lives that are covered now. So they have access to the drug.

It's Barry so on the gross to net so as we said as we continue to get better coverage as the a and D. C blocks removed our gross to net as Christiana said is going to improve in the second quarter in the third quarter and fourth quarter.

So we have a 146 million lives that are covered now so they have access to drug and are as far as our full buy down program goes.

Barry: And as far as our full buy-down program goes, we knew from the very beginning when we launched this drug that we wanted to have a generous patient assistance program, where if a dermatologist wrote the prescription, the patient would be able to get it, regardless of NDC blocks. As those NDC blocks are removed and utilization criteria are written, then we take down those full buy-down programs. And that actually does improve our GrossDinet over time, because it's just unnecessary.

Knew from the very beginning when we launched this drug that we wanted to have a generous.

Program patient assistance program, where if a dermatologist wrote a prescription the patient would be able to get it regardless of N. D. C blocks as those N D. C blocks are removed and utilization criteria are written then we take down those for.

Those full buy down programs and that actually does.

Prove our gross to net over time, because it's just unnecessary now.

Barry: Now insurance companies are going to pay for it. As far as coverage goes, I mean, just as I said, the prescribing is not impacted. We did not want it to be impacted, because we had a generous patient assistance program in place. And there really hasn't been any barriers.

<unk> companies are going to pay for it as.

As far as coverage goes I mean, just as I said.

At the prescribing is not impacted we did not want it to be impacted because we had a generous patient assistance program.

<unk> in place and are there really hasnt been any barriers as prior approvals of course come into place dermatologists in their offices are very familiar with going through the prior approval process every.

Barry: As prior approvals, of course, come into place, dermatologists and their offices are very familiar with going through the prior approval process. Every prescription for psoriasis, every prescription for atopic dermatitis or branded drugs all have to go through prior approval. So there really isn't the barriers.

Every prescription for psoriasis every prescription for atopic.

Atopic dermatitis for branded drugs I'll have to go through prior approval. So there really isn't a the barriers and we tried to remove those barriers as much as we could so people could get a great experience with absolutely right and we know that they really having great experience with absolute <unk> physicians dermatologists are telling us theyre, having great experience with absolute are so we think.

Barry: And we tried to remove those barriers as much as we could, so people could get great experience with Opsalora. And we know that they're really having great experience with Opsalora. Physicians, dermatologists are telling us they're having great experience with Opsalora.

Barry: So we think the uptake that we're experiencing now is going to continue throughout the end of the year and beyond. Your next question is coming from Corey Kazimoff from JP Morgan. Your line is now live. This is Gavin.

Uptake that we're experiencing now is going to continue throughout the end of the year and beyond.

Okay.

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

Gavin: Thank you for taking our question. There's been a lot of folks in Opsalur, so I'll stay away from that, but just on the pipeline, I guess, the Adenosine Program and CD73, this has been an increasingly competitive area of development. Perhaps you can just frame some expectations for us on the initial data we're expected to see later this year. Thank you. Again, hi, it's Steven.

Hi, This is Gavin on thank you for taking my question.

Been a lot of books.

I'll stay away from that but just on the pipeline I guess.

The adenosine program at <unk> 73, this has been increasingly competitive area of development.

So you can just bring some expectations for us something that initial data we're expecting to see later this year. Thank you.

Steven: Thanks for bringing that up. Yeah, we have, you know, all three components of the program that's needed are in our pipeline. So we have a small molecule potent and selective A2A, A2B inhibitor. We have a large molecule CD73 inhibitor. And then we have the combination availability with checkpoint inhibitors, either IV and radiofanilamab or oral with the oral PD-L1 program. So that's somewhat of the uniqueness.

Hey, Kevin Hi, it's Steven Thanks for bringing it up yes, we have.

All three components of our of the program that's needed are in our pipeline. So we have a small molecule.

Potent and selective <unk> inhibitor, we have a large molecule <unk> 73.

EBITDA and then we have the combination availability.

With with checkpoint inhibitors, either IV and read a family member or with the oral PD Lone program. So that's somewhat of the uniqueness then in terms of the <unk> and CD 73, we are slightly behind the competition, but we have the ability to learn from them and see where they go and you're right.

Steven: Then in terms of, you know, the A2A, A2B, and CD73, you know, we are slightly behind the competition, but we have the ability, you know, to learn from them and see where they go. And you're right, you know, there is a lot of interest in inhibiting adenosine in the tumor microenvironment, either through a doublet or triplet, as I point out. The dose escalation and expansion phases for the A2A, A2B have gone very well and on track with data this year, and CD73 slightly behind, but also on track. And now we're doing the doublets.

There is a lot of interest in inhibiting adenosine in the tumor microenvironment, either through a doublet or triplet as I pointed out the dose.

Steven: So we're progressing well with the program and expect to provide you some updates in the second half of 2023. Great, thank you. Your next question is coming from Mara Goldstein from Missouhi. Your line is now live.

Escalation and expansion phases for the <unk> to a <unk> have gone very well and on track with data this year and <unk> 73, slightly behind but also on track and now we do and the tablets. So we are progressing well with the program and expect to provide you some updates in the second half of 2022.

Okay, great. Thank you.

Thank you. Your next question is coming from Mara Goldstein from Mizuho. Your line is now live.

Mara Goldstein: Oh, great. Thanks so much for taking the questions. I just wanted to ask, I know we talked a lot about Apsalora, but I just wanted to get a little bit of clarification on the growth to net steady state at 40 to 50 percent. And is that also anticipated, you know, in a post-vitiligo commercialization, that that would be sort of the long-term steady state? And then also, is there any update on the NDA filing for RUX QD?

Oh, great. Thanks, so much for taking that quest.

Question I just wanted to ask I know we talked.

A lot about absolutes, but I just wanted to get a little bit of clarification on that question at that.

Okay.

And is that also anticipated.

On a post.

Commercialization that that would be sort of a long term study.

And then also is there any update on the envelope firearm for a lack of T D.

Mara Goldstein: Sure, I'll take the first part of your question, Mara. So yeah, so the growth to net that we say 40-50% includes the Vitiligo launch and going forward with AD and Vitiligo our growth to net will will try to keep in that range as we possibly can But we're very confident going through the year as we said by the end of the year Second half of the year 40 to 50% is our goal. I'll turn the other one about RUX QD over to Stephen. Hi Mark, Stephen.

Sure I'll take the first part of your question Mara.

So yes, so the gross to net that we say 40, 50% includes a bit of like a launch and going forward with a D and vitiligo a gross to net will we'll try to keep them in that range as we possibly can but we're very confident I've gone through the year as we said by the end of.

The year second half of the year of 40% to 50% as our goal I'll turn the other one about executing over to.

Barry: So RUX, Our RUX once a day file is going in now, this half of 2022. The critical part was stability, which is complete. We expect a standard 10-month review period, so it should be first quarter of 2023 that we'll be expecting that approval. The reason we expect it to be successful is that from a bioavailability, bioequivalence point of view, we met the criteria that's in the FDA guidance for area under the curve, so we're within that range that's required for the multiple dose strength. And now that stability has been complete, you know, we have confidence in that submission and should have it actioned around, you know, the first quarter of 2023. Thanks. Thank you very much.

Yeah, Hi, Mark Stevens So Rex.

<unk> once a day fall is going in now this half of 2022. The critical path was stability, which is complete we expect a standard 10 month review period. So it should be first quarter of 2023 that will be expecting that approval. The reason we.

To be successful is that from a buyer availability bio equivalents point of view, we met the criteria. That's in the FDA guidance for area under the curve. So we're within that range thats required for the multiple dose strengths and now thats abilities being complete you know we have confidence in that submit.

And should have it actions are around.

First quarter of 2023.

Thank you very much.

Steven: Thank you. Our next question is coming from Marc Frahm from Cowan & Company. Your line is now live. Thanks for taking my questions. Just back to Vitiligo's very good combination of Barry and maybe Steven.

Thank you. Your next question is coming from Mark from Cowen and company. Your line is now live.

Marc Frahm: Just for the label, what do you guys view as kind of the important elements to get in there from a commercial perspective, you know, particularly to driveways, because Sean mentioned, you know, that, Increased patient flow into the clinic seeking treatment and kind of what are the elements of the true beef studies that you know probably aren't going to be in the label but are going to be important to kind of stress to the community to drive that, I mean, you know, I'll turn it over to Steven. I'll try to give you an answer to your question.

Hi, Thanks for taking my questions.

The combination of Berry and maybe Steven.

So the label.

Do you guys view as kind of the important elements to get in there from a commercial perspective.

Particularly to drive Buzz Kushan mentioned, you know that.

Increased patient flow into the clinic seeking treatment and kind of what are the elements of the <unk> studies that you probably aren't going to be in the label, but we're going to be important to stress to the community to drive that else.

I mean.

I'll turn it over to Stephen I'll try to give you an answer to your question I actually think the most important thing is just that this is the first and only drug approved for a re pigmentation of vitiligo and it's there really should be no barriers are really other than that if Stephen has other viewpoints about.

Marc Frahm: I actually think the most important thing is just that this is the first and only drug approved for repigmentation of vitiligo, and there really should be no barriers, really, other than that. If Steven has other viewpoints about what should be included or not included in the label, I'm not sure. Yeah, hi Marc and Steven.

What should be included or not included in the label I'm not sure.

Steven: You know, I think if you go back to the eligibility criteria from the two large phase three studies, you know, the age would be key, you know, 12 and above, the body surface area involvement up to 10%. And in the dosage and administration section, we feel that it's likely to reflect the fact that it's different from AD and that, you know, continuous dosing is needed to achieve the benefits I spoke about in my prepared remarks, which are quite remarkable.

Yeah, Hi, Marc It's Steven I think if you go back to the eligibility criteria from the two large phase III studies.

Age would be key 12.

12, and above the body surface area involvement up up to 10% and then the dosage and administration section we feel that it's likely to reflect the fact that it's different from 80 and that continuous dosing is needed to achieve the benefits I spoke about in my prepared remarks, which are quite remarkable.

Steven: When you get, you know, over time, you know, 20% absolute percentage improvement in facial VASI 75 between week 24 and week 52. On the week 52 point, you know, the initial submission was obviously on the primary end point on week 24.

When you get you know overtime, you know, 20% absolute percentage improvement in facial <unk> 75 between week 24, and week 52 on the week 52 point in there.

The initial submission was obviously on the primary endpoint on week 24 during the four months safety update we were able to provide some of the 52 week data, but now with the three month extension on the <unk>, we've been able to was to supply more of their data so that would be a good upside and obviously it will depend on the FDA.

Steven: During the four-month safety update, we were able to provide some of the 52-week data. But now, you know, with the three-month extension on the PDUFA, we've been able to also supply more of that data. So that would be a good upside.

Patients that are forthcoming to have the complete 52 week data set in.

So reflective entirety of both the efficacy and the safety data.

Steven: And obviously, it will depend on the FDA and the negotiations that are forthcoming to have the complete 52-week data set in to reflect the entirety of both the efficacy and the safety data. Thank you. Okay, that's helpful. Maybe Steven, for 707, the update's coming in the second half, across, some of the other dermatology indications. What do you view as kind of meaningful responses in hydrogenitis to move forward with this type of mechanism given kind of all of the labeling concerns?

Okay. That's helpful and maybe just even.

For 770, <unk> the updates coming in the second half.

Some of the other dermatology indications.

What do you view is meaningful.

Responses in Hidradenitis, you know to move forward with this type of mechanism given kind of all the LIBOR and concerns around around Jack and then on the vitiligo side. It's the long term plan there with that too can have people on oral therapy chronically or is it more of just get them to a place where absolute.

Steven: and then on the vitiligo side is the long-term plan there with that to kind of have people on oral therapy chronically or is it more of just get them to a place where Opsalur becomes a better option for them and then they transition to Opsalur? Yeah, thanks Marc for both questions. So, high-radion autosuperativa, you know, distressing condition for patients, a lot of unmet need, there is an approved TNF inhibitor, but not widely used in the syndication, probably due to somewhat, you know, a lack of efficacy with it. It's a condition that involves abscesses, nodules, and scarring in, you know, in areas of the body like the armpits, axilla, and groin, and it can, you know, be very distressing psychologically to patients as well.

Where it becomes a better option for them and then they transitioned top solar.

Yeah. Thanks, Mark for both questions. So high rated or not is super T. The distress in condition for patients a lot of unmet need there isn't approved TNF inhibitor, but not widely used in the in the syndication probably due to somewhat lack of efficacy with it it's a condition that involve.

Those absences nodules and scoring in and in areas of the body like the Ah <unk> and growing and it can be very distressing psychologically to patients as well the established endpoint for the one approved drug is stemming Calder his scar endpoint.

Steven: The established endpoint for the one-approved drug is something called the Hiscar endpoint. It attempts to capture the improvement in abscess and nodule formation, and seems to be, you know, the regulatory-required endpoint that's needed. But you're right, it's tricky to measure.

Attempts to capture the improvement in axis, and nodule formation and seems to be you know the regulatory reprised.

Endpoint, that's needed, but you're right. It's it's it's a tricky to measure there is both the object and subject of components to it but the in our phase II data, which we'll show you. We feel is very encouraging for the effect of a JAK inhibitor in this unmet need area.

Steven: There's both object and subjective components to it, but the, you know, our Phase II data, which we'll show you, we feel is very encouraging for the effect of a JAK inhibitor in this unmet need area. Just to address, you know, the safety part of what you said, you know, we fully expect, given that this is an oral JAK inhibitor, you know, in an inflammatory condition, clearly an inflammatory condition, that it's likely that we'll be dealing with black box class labeling language. I mean, that has been, you know, known to us for a while now.

Just to address the safety part of what you said, we fully expect given that this is an oral JAK inhibitor.

And in an inflammatory condition clearly an inflammatory condition that its likely that we will be dealing with a black box class labeling language. I mean that has been you know no in test for a while now and so we feel you know the therapeutic ratio is important right. So in settings of high unmet need with lot of severity with it.

Steven: And so we feel, you know, the therapeutic ratio is important, right? So in settings of high unmet need with a lot of severity, with the efficacy that we desire, you'll get to the desired therapeutic ratio that's needed to use the drug. So that's the HS component.

Efficacy that we desire you'll get to the desired therapeutic radio that's needed to use the drug.

So that's the Hs component for very long ago, Yeah, I, just want to stress that it's different from the cream indication. So this is for people with more extensive body surface area involvement the principal eligibility criteria is 8% or above body surface area involvement. So it's a little confusing because the cream is.

Steven: For vitiligo here, I just want to stress that it's different from the cream indication. So this is for people with more extensive body surface area involvement. The principal eligibility criteria here is 8% or above body surface area involvement. So it's a little confusing because the cream is 10% or below, and this is 8% or above, so there's a little bit of overlap. But it gets to the therapeutic ratio question again, that these are people with extensive vitiligo, that there'll be more acceptance to use, you know, an oral JAK inhibitor with a different therapeutic ratio. We know it's efficacious.

10% or below and this is 8% or above so theres, a little bit of overlap, but it gets to the therapeutic ratio question again that these are people with extensive it long ago that there'll be more acceptance to use.

Steven: I mean, you know now from the cream data, from multiple reports with oral JAK inhibitors, that you get, you know, repigmentation here. But you'll have to have, you know, suitable safety. And again, you know, we're very likely to be dealing with the black box labeling down the pipe when it gets there, and that'll, you know, factor into our decision making with that particular indication. Thanks. Okay, thank you. Thank you. As a reminder, that's star one to be placed in the question queue. Our next question today is coming from Jay Olson from Oppenheimer. Your line is now live. Hi, this is Chong on the line for Jay.

Oral JAK inhibitor with a different therapeutic ratio, we know it's efficacious I mean, you know now from from the cream data from multiple reports with with oral JAK inhibitors that you get a re pigmentation, yeah, but you'll have to have suitable safety and again, you know, we're very likely to be dealing with.

Black box labeling down the park when it gets there and that'll fix.

Factor into our decision making.

With that.

Particularly indication thanks.

Okay. Thank you.

Thank you as a reminder, that star one to be placed in the question queue. Our next question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Hi, This is shown on the line for let's.

Let's take another question.

Chong: Thanks for taking the question. I guess on the oral PD-L1 program, I'm just curious, any learnings like dosing optimization or tumor selection that you can apply to the development of the follow-on molecules you are prioritizing right now? And also between these two follow-on molecules, would you further prioritize one over the other? If so, when will that happen?

I guess on the oral PD Lone program.

I mean, just curious any learning like dosing optimization or tumor collection.

Can you kind of apply to the development out there for a lot of money keeps you are prioritizing right now and also between the two molecules would you are there as well.

One over the other if so when would that happen. Thank you.

Steven: Thank you. Chang, hi, it's Steven. So, you know, in terms of dose, I don't know exactly what you're alluding to, but just to make broad comments, and across, you know, all areas at the FDA, but particularly in oncology now, there's Project Optimist, there's a refocus on getting the dose correct. It's likely that everybody in the space now will have to do a lot more dose work, a lot more exposure efficacy analysis, a lot more exposure toxicity analysis, and may even be, down the pike, an area where we'll be taking more than one dose into pivotal studies.

Yes, Shanghai, it's Steven.

In terms of dose.

Exactly what you're alluding to but just to make broad comments and our cros.

All in all areas at the FDA, but particularly in oncology now there's project Optimus, there's a refocus on getting the dose correct. It's likely that everybody in this space now we'll have to do a lot more dose work a lot more exposure efficacy analysis, a lot more exposure toxicity enel.

<unk> and may even be down the pike.

An area, where we will be taking more than one dose into pivotal studies.

And you know you cannot argue that getting the dose right is critically important that this effort from the regulators will be a big deal and you know we've already adapted like many other companies.

To have the right resources now to do these analysis and get it right.

Steven: And, you know, you cannot argue that getting the dose right is critically important, that this effort from the regulators will be a big deal, and, you know, we've already adapted, like many other companies, to have the right resources now to do these analysis and get it right. For oral PD-1 specifically, we do have a pharmacodynamic marker. We can measure PD-1 inhibition in peripheral blood mononuclear cells, so we know, you know, that we get in the right degree of inhibition, and just to be clear, we want 90% or above inhibitory concentrations of that PD marker constantly when we dose our drugs.

For Aro PD, one specifically, we do have a pharmacodynamic marker, we can measure a PD one inhibition in peripheral blood mononuclear cells. So we know that we get in the right degree of inhibition and just to be clear, we want at 90% or above inhibitor.

<unk> concentrations of that PD marker constantly.

When we dose how drugs. So we're working on that now with both.

Steven: So we're working on that now with both 280 and 318. You know, your question around what histologies are important, it somewhat remains to be seen. I mean, given that we now know these are all active compounds, we've seen activity in areas that are known to be IO responsive, so the hotter tumors, if you will, microsatellite high tumors are also of particular interest here, so that's currently the main focus. As I said in my prepared remarks, you know, given that it's oral, that it may differentiate on safety with its quick off-rate, you can do oral-oral combinations, people can go home and not need to come into a clinic setting for infusions, it could lend itself more also to adjuvant and maintenance settings, but we're not there yet in declaring what particular histologies and what area we're going to particularly go after.

Two eight and 318.

Your question around what histology as are important.

It's somewhat remains to be seen I mean, given that we now know that these are all active compounds. We've seen activity in areas that are known to be Io responsive. So the hotter tumors. If you will microsatellite high.

Tumors are also of particular interest yeah. So that's currently the main focus.

As I said in my prepared remarks, you know given that it's our old that it may differentiate on safety with its quick off rate you can do oral oral combinations people can go home and not coming and not need to come into a clinic setting for infusions. It could lend itself more also to adjuvant and maintenance settings, but we're not there yet.

In declaring what particular strategies and what area are we going to particularly go after we hope though to be making those decisions towards the end of this calendar year, perhaps early next year on where we'll be going from a registration point of view. Your last question as regards what we take both Florida only.

Steven: We hope, though, to be making those decisions towards the end of this calendar year, perhaps early next year, on where we'll be going from a registration point of view. Your last question as regards, you know, will we take both forward or only one in terms of 280 and 318, I still think it's a little premature to answer.

Leon: We have both in the clinic at the moment, both are enrolling well, both have shown, um.., tumor reduction in terms of shrinkage and no neuropathy with either agent yet and we'll do more of what I was talking about in terms of dose optimization and modeling before declaring which particular one will take forward in oncology but you know my own view at this juncture there may be interest in non-oncology settings for example enhancing hepatitis B virus directed therapies etc so there may well be utility down the park in having a second compound for non-oncology settings it's just a little early to declare which way we'll go thanks, Great, thank you. Thank you. Next question today is coming from Leon Wang from Bank of America. Your line is now live. Hey, thanks. This is Leon Lundquist calling for Tazeen Ahmad.

One in terms of tomato and 318 I still think it's a little premature to answer we have both in the clinic at the moment both are enrolling well both have show in June .

<unk> reduction in terms of shrinkage and no neuropathy with either agent yet and we'll do more of what I was talking about in terms of a dose optimization and modeling before declaring which particular one we'll take forward in oncology, but you know.

My own view at this juncture there may be interest in non oncology settings. For example, enhancing hepatitis b virus directed therapies et cetera. So they may well be utility down the pike and having a second compound for non oncology settings. So it's just a little early to declare which way we'll go.

<unk>.

Great. Thank you.

Thank you. Your next question today is coming from Leon Wang from Bank of America. Your line is now live.

Barry: I guess one more question on Opsalora Rosinet. You previously mentioned that one of the benefits of talking to payers relating to Bitoligo is that when your current negotiations and when Bitoligo is approved, you don't have to necessarily go back to payers to negotiate brand new contracts. Now, if that's the case, and would you say some payers are waiting for the label of Bitoligo to be approved before kind of finalizing the payer coverage negotiations?

Hi. Thanks. This is a we don't want to call them.

Going forward Bob.

I guess one more question.

Absolutely.

Gross that you previously mentioned that one of the benefits of pockets of payers related to that or why go with that one.

Negotiation.

It was a bit of like or you don't have to necessarily go back to payers to negotiate brand new contracts now that's the case.

Would you say some payers are waiting for the label that are liable to be approved before kind of finalized.

Barry: So I'm trying to understand the cadence of when you might see that next, basically, percent lives covered and improvement from that dynamic. And my second question is, previously, you mentioned the gross net range could normalize anywhere between the 30% to 50%. Today, you said, expect that to be around 40% to 50% by the end of 2022. But just as a clarification, going forward beyond 2022, do you see, I guess, potentially gross net discounting to be somewhere lower, perhaps in the 30% to 40% range? Thank you. So, Leon, this is Barry.

Their coverage negotiations, so I'm trying to understand.

Cadence.

See that next.

Basically the percent of lives covered.

That's right.

And my second question is previously mentioned.

Gross to net range to normalizing for between 30% to 50%.

Today, you said.

That should be around 40% to 50% by the end of 2022, but just as a clarification going forward beyond 2022.

I guess potentially.

Gross to net discounting.

Perhaps I'm, a 30% to 40% range.

Barry: So, as far as the negotiation goes for Vitiligo, no, we don't have to go back. So, there's a couple of different things. One is that you're talking about, you know, contracts with PBMs for the large part. So, that's one part. So, those contracts are, at least one is fully completed. And remember, those are divided into two parts. So, the three big PBMs really cover about 80% of the commercial lives in the country. But think about that as variable and non-variable.

So liana this is Barry.

So as far as negotiation goes for vitiligo no. We don't have to go back. So there's a couple of different things. One is that are you talking about.

Contracts with the Pbms, but a large part.

So that's a that's one parts. So those contracts are at least once fully completed and remember.

Those those are divided into two parts are the three big Pbms really cover about 80% of the commercial lives in the country, but think about that as a.

Variable and non variable about 50% of patients are let's call them variable where in fact, the plans insurance plans themselves like you and I have.

Barry: About 50% of patients are, let's call them variable, where, in fact, the plans, the insurance plans themselves, like you and I have, they, in fact, can make their own decisions and, in fact, write their own utilization criteria about how the drug's being used. So, we don't have to go back and negotiate. And then the other half, sorry, are the ones that you might say are a preferred formulary, where they have true NDC blocks.

They are they in fact can make their own decisions and in fact write their own utilization criteria about how the drugs being used so we don't have to go back and negotiate and then the other half sorry are the ones that you might say, our a preferred formulary, where they have true mtc blocks. So we have.

Barry: So, we have one of the big PBMs that are fully NDC block removed, and the rest of the variable plans have written their utilization criteria. And then, in fact, when we launch Fiddle-Ligo, we don't have to go back and negotiate with the PBMs for new contracts. But utilization criteria, once Fiddle-Ligo is launched, will be written by the plans, and it will take weeks to months for those utilization criteria to be written for each of the various insurance plans, of which there are many throughout the country. Before launch, no, they're not going to have utilization criteria. Before approval, they're not going to have utilization criteria written for Fiddle-Ligo.

One the big Pbms that are fully in D. C block removed and the rest of the the.

Variable plans have written their utilization criteria.

And then we.

And then in fact, when we launched vitiligo, we don't have to go back and negotiate with the Pbms for new contracts, but utilization criteria. Once <unk> is launched will be written by the plants and it will take weeks to months for those utilization criteria to be to be.

Written for each of the various insurance plans of which there are many throughout the country.

Before.

Lunch no, they're not going to have utilization criteria before approval, they're not going to have utilization.

Utilization criteria written for vitiligo in.

Barry: In fact, even though they know about the Phase III data for Opthalura and Fiddle-Ligo, they're not going to write a plan until it's approved because they just don't want to take the time to do that. But we're educating, of course, payers that this is, in fact, coming, and they know it's coming, and we know that they're going to write utilization criteria for it because most of them have utilization criteria already for other products, not all of them, but some of them do, for things like light therapy and so forth.

In fact.

Even though they know about the phase III data for <unk> for apt Laura in vitiligo.

They're not going to write a plan until it's approved because they just don't want to take time to do that but we're educating of course payers that this is in fact coming.

And there they know it's coming and we know that there.

They're going to right.

Right utilization criteria for it because most of them have utilization criteria or ready for other products not all of them, but some of them do for things like light therapy, and so forth. So we know that our users.

Barry: So, we know that utilization criteria will be written for Fiddle-Ligo. As far as the gross net is concerned, at least for over this year, last couple of quarters, we've always said 40% to 50% gross net is our goal, and that's what we're shooting for, particularly as we continue to negotiate with the various payers.

Utilization criteria would be written for vitiligo as far as the gross to net is concerned at least.

For over this year last couple of quarters, we've always said, 40% to 50% gross to net is our goal and that's what we're shooting for it particularly as we continue to negotiate with the various payers.

Barry: Thank you. Our next question today is coming from Andrew Berens from SVB. Your line is now live. Hey, this is Chris on for Andrew Berens.

Thank you. Our next question today is coming from Andrew Berens from SBB. Your line is now live.

Chris: I was just wondering if we could get a little bit more color on the prescriber details for Opsalura. How many dermatologists and how many general practitioners are in the mix for Opsalura? And are those docs primarily those that you've detailed to from the sales force or are you seeing more of a halo effect? And then just as a quick follow-up question, I'm wondering if the new product manufacturing method for Opsalura is going to change anything fundamental about the drug, the PK or the pH or anything like that?

Hey, this is Chris on for Andrew Burns.

I was just wondering if we could get a little bit more color on the prescriber details, perhaps the lira, how many dermatologists and how many general practitioners are in the midst Rob silvera.

Are those docs, primarily those that you detailed two from the sales force or are you seeing more of a halo effect.

Just as a quick follow up question.

I'm wondering if the new product manufacturing method for obsolete right, it's going to change anything fundamental about the drugs PK or.

You know the ph or anything like that and if so is that going to concern any of the regulatory agencies in terms of the safety and efficacy.

Chris: And if so, is that going to concern any of the regulatory agencies in terms of the safety and efficacy? So, Chris, I'll take the first part and hand the second part over to Stephen, but as far as, there's about 8,000 dermatologists in the United States or so, and general practitioners, no, we don't really see any. I mean, they could obviously write for Opsalur, but we really don't see any.

So Chris I'll take the first part and hand in hand, the second part over to to Steven but.

As far as there's about 8000.

Dermatologists in the United States, or so and general practitioners no. We don't really see any I mean, they could obviously right drops Laura but we really don't see any all of our detailing all of our educational work goes towards dermatologists and their offices, but remember, especially in dermatology nurse practitioner.

Barry: All of our detailing, all of our educational work goes towards dermatologists and their offices. But remember, especially in dermatology, nurse practitioners and physician's assistants are very important. They're prescribers. There's tens of thousands of them, so when we call on dermatologists' offices, we, of course, call on the nurse practitioners, and the physician's assistants are very important. In fact, the medical assistants as well that are very important, particularly when it comes to reimbursement.

<unk> and physicians assistants are very important they're prescribers, there's tens of thousands of them. So when you call on dermatologist offices, we of course call on the nurse practitioners and Pas.

<unk> assistance are very important in fact, the medical assistance as well that are very important, particularly when it comes to.

Barry: So, it's all direct education, and we're working very well and have reached all of our top prescribers and will continue to educate all of the dermatologists, nurse practitioners, PAs, and the offices, as we move forward for the product manufacturing changes, I'll turn it over. Yeah, Chris, thanks for your question. I mean, the top line clear answer is there's nothing fundamental changed on the drug currently as regards PK or pH. The CVE-30 change, you know, by the regulations is a mild to moderate change that specifically doesn't do that.

Reimbursement so it's all direct education.

And we're working very well and have reached all of our top prescribers and will continue to educate all of the dermatologist nurse practitioners P. As in the offices.

As we move forward towards there.

Product manufacturing changes I'll turn it over to Steven Yeah, Chris. Thanks for your question I mean, the top line clear answer is there's nothing fundamental change on the drug currently as regards PK or P. H. The CBE 30 change you know by the regulations is a mild to moderate change the specifics he doesn't do that in the.

Barry: And the prior approval supplement change was bringing a new manufacturer on board using the same process. In fact, you specifically do not want to do what you allude to because that would require you to redo all your clinical studies. So you have to be very careful to not make changes that affect those in any substantial way, either PK or pH.

Prior approval supplement change was bringing a new manufacturer onboard using the same process. In fact, just specifically do not want to do what you allude to because that would require you to redo all your clinical studies. So you have to be very careful to not make changes that affect those in any substantial way either.

Chris: So thanks. Got it, thank you very much. 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 closing, Thank you all for participating in the call today and for your questions. The IR team will be available for the rest of the day for follow-up. Thank you and goodbye. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your...

K R P H.

<unk>.

Got it thank you very much.

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

Thank you all for participating in the call today and for your questions. The IR team will be available for the rest of the day for follow up Thank you and goodbye.

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.

Yeah.