Q2 2022 Incyte Corp Earnings Call

Hello, and welcome to the insight second 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.

Hello, and welcome to the Incyte second 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.

If anyone should require operator assistance, 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.

If anyone should require operator assistance. 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.

Thank you, Kevin.

Yeah, so it was, Evan, it was temporary.

I'd like to turn the floor back over to Christine for any further closing remarks.

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

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

We believe we had a problem mostly with, you know, the large portion of our prescriptions are filled by independent pharmacies. So it took us a little while to work together with them to work out them getting back to doing prior approvals, which they're very familiar with.

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 every day.

Good morning, and welcome to Incyte's second quarter 2022 earnings conference call and webcast.

And we're very confident that that was, in fact, temporary.

Thank you all for participating in the call today and for your questions.

Okay.

Now the growth net of 40 to 50 percent going forward in, 2023 and beyond, we're certainly going to do everything we can to protect our growth net.

Thank you Christine and good morning, everyone.

As you know, the PBMs and pairs will always come back and try to get more and more and more.

So we just keep on working to maintain that growth net because we think the value that this product offers is exceptional, and we don't want to lose that value.

The slides presented today are available for download on the investor section of our website.

Okay, great.

The IR team will be available for the rest of the day for follow-up.

Hum.

In the second quarter revenues increased 29 defense yoga, reaching $911 million.

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

Thank you.

Thank you and goodbye.

Jakafi net sales grew 13% to 598 million benefiting from growth in new patient starts in all three indications.

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 followed with the SEC.

The contribution.

Sorry, the contribution from our well although in a matter of general Crunchy product continues to increase as the launches of Amazon in jewelry progress in Europe and Japan.

We also made significant progress with the launch of a video already that's a big number that is where.

Where we now have the sub P. B M GPO contract sign.

Key milestone in achieving broad formulary access and an important step towards accelerating the growth of up to one that's revenue.

As we shift from free drug to paid prescriptions, we are seeing some temporary delays in the feeding of prescription which had an impact on second quarter revenues. However, based on the demand and satisfaction remained strong and improvements in reimbursement are translating to an increase in claims with a significantly increased scene.

In July .

These metrics are pointing to a continuation of our successful launching atopic dermatitis.

Turning to slide five two weeks ago.

<unk> was also approved for the treatment of non cig mentality like becoming.

The first and only therapy for re pigmentation for these patients.

Yeah prevent them from Sidra was a momentous occasion for the millions of people living with the disease and generated a tremendous amount of excitement in the dermatology community with that book at the groups on patients.

Turning to slide six.

We also had multiple that provoked the squad over with our product <unk> was approved as a first but steroids systemic treatment for both acute and chronic gvhd in Europe , what do you mean.

Two is approved as a first and only systemic treatment for alopecia Areata things the U S Europe and Japan.

And the breakdown received European approval for a subgroup of patients with non small cell lung cancer.

Together these improvements provided insights with 113 million of milestone revenues and will contribute with royalties to our future revenue growth.

Finally, looking at some of the additional highlights of our pipeline on slide seven Bobo CIT didn't need them.

Formerly known that sit on the sedan is nowhere in preparation for a phase III study in it says photos.

Following the positive results from our phase II trial.

As part of the Limber program I N D clearance was received for seeking 082 for the Vancouver cord blood derived direct sales.

Therapy drugs already neutral the treatment of myelofibrosis.

We also received FDA clearance.

Acceptance of the NDA submission for Xerox 13 Abe.

With a pitiful date of March 27.

And lastly in early development, we expect to initiate the clinical program later this year, along with 459 luxury PD one by specific antibody developed in partnership with mirrors.

We have multiple ongoing studies across dermatology Lindbergh and hematology oncology as you can see on the right where each represents a meaningful opportunity and puts us in excellent position for future growth and diversification.

With that I'll turn the call over to Barry.

We will now begin the call with Herve.

Thank you.

Thank you.

Thank you Ravi and good morning, everyone.

Starting with up to Laura the launch in atopic dermatitis continues to be strong and we are very pleased with the progress that we have made across a number of important metrics.

Thank you, Christine, and good morning, everyone.

Our next question today is coming, from Michael Schmidt from Guggenheim Partners.

Your line is now live.

Hey, thanks for taking my questions.

To date over 10000 physicians have prescribed absolutely with new writers being added each week physicians continue to report a high level of satisfaction with hustler with 67%, stating that they are highly satisfied up from 46% earlier. This year. Additionally in a recent poll physicians indicated nearly half of their <unk>.

I had another one on Opsalura.

Just maybe talk about your confidence in script data, and the increase in demand in the third quarter.

Patients would be appropriate candidates for <unk> up from 37% earlier this year.

Efficacy, including rapid itch reduction as well as Colorado.

Tolerability and the ability to use absolutely insensitive areas remain the key product attributes and we expect these attributes to continue to drive demand for absolute aura in E D.

Turning to slide 10.

Earlier this month, we announced that we now have signed contracts with the largest with the three largest P. B M Gpus and outstanding achievement 10 months into launch and a key step towards reaching our steady state gross to net coal.

The contract with a third P. B M became effective July 1st.

And individual plans will now be adding <unk> to their formularies.

The charts shown on this slide is our internal <unk> seven data, which is the number of absolute units shipped from wholesalers to pharmacies.

With regards to Ikea via data there has been an increased variability with the data in recent weeks. The overall trend shown by activity of data is representative of the actual kinetics. However, the number of filled prescriptions as reported by acute yet are being over projected.

It is important to take away from this slide a couple of points. Both on Q2 performance and on recent trends in the second quarter as N. D. C blocks were removed in absolute <unk> was added to formularies pharmacist and dermatologists began to shift from the processes. The free drug program to going through the formulary process.

In the second quarter, revenues increased 29% year-over-year, reaching $911 million.

Jaka-5 net sales grew 13% to $598 million, benefiting from growth in new patient start in all three indications.

The contribution from our other hematology and oncology products continued to increase as the launches of Temazir and Minjuvi progressed in Europe and Japan.

We also made significant progress with the launch of Opzellura in atopic dermatitis, where we now have the third PBMGPO contract signed. This is a key milestone in achieving broad formulary access and an important step toward accelerating the growth of Opzellura net revenue.

As we shift from free drug to paid prescription, we are seeing some temporary delays in the filling of prescriptions, which had an impact on second quarter revenues. However, patient demand and satisfaction remain strong, and improvements in reimbursement are translating to an increase in covered claims with a significant increase in July.

This shift test two different effects, one is a temporary delay a fault filled prescriptions, which you saw in the second quarter and two is the positive impact uncovered claims the benefit of which will be more pronounced beginning in Q3.

These metrics are pointing to a continuation of a successful launch in atopic dermatitis.

We are already seeing a return of 867 demand to within the range of our highest point since launch. Additionally, the percentage of covered claims as shown by the red by the Red line has risen rapidly from the mid 20% range at the end of June to nearly 55% today, we anticipate with the with the.

The effect of an increased number of build prescriptions and improving gross to net obsolete or it will have a more meaningful contribution to net sales in the second half of this year.

Turning to slide five, two weeks ago, Opzellura was also approved for the treatment of non-segmental vitiligo, becoming the first and only therapy for repigmentation for this patient.

On slide 11, we're turning to vitiligo. This slide captures some of the highlights from <unk> FDA approved label as the first treatment for re pigmentation and did a Lego. This is a historic approval for patients living with this disease and the and the approved label includes a number of important points that will help to drive the success.

The approval of Opzellura was a momentous occasion for the millions of people living with the disease and generated a tremendous amount of excitement in the dermatology community with advocacy groups and patients.

SaaS had the product in this indication.

So Laura is approved for patients 12 years of age and older and can be applied to affected areas up to 10% BSA.

The label allows for continuous use of absolutely anywhere on the body, including sensitive areas with no limit on duration of use the 52 week efficacy data, which has been included in the label demonstrates the continued improvement in re pigmentation with longer duration of treatment.

Lighting the importance of staying on therapy. The label also notes that is satisfactory patient response may require treatment with absolute are for more than 24 weeks.

And lastly, absolute <unk> was well tolerated with application site acne is the most common AE and 6% of the patients.

Turning to slide six, we also had multiple approvals this quarter with our partner products. JAKAVI was approved as the first post-steroid systemic treatment for both acute and chronic GVHG in Europe.

Turning to slide 12 for the launch in Vitiligo remember these are the same target physicians as with a D, where we will be able to leverage our existing relationships with physicians and to be able to benefit from the high level of satisfaction and experience that may have at many already have with Epsilon are at today.

Our launch is underway with a comprehensive multichannel marketing campaign that will ensure broad and consistent reach to effectively drive awareness and importantly to educate physicians on <unk> mechanism of action its impact on <unk> and its unique clinical profile.

To support the launch of <unk> in vitiligo from the patient perspective, we're focusing on raising awareness and providing best in class support we plan to build awareness and activate patients living with vitiligo through a strong presence on social media print and eventually T D.

We're also partnering with advocacy groups, where there has been an enormous amount of excitement for opt to Laura and the Lego. This will be the first treatment for re pigmentation available for these patients and the safety and efficacy profile has been proven in the largest randomized clinical trial in this setting.

It is important to drive patient adherence and compliance and up to Laura. This will of course begin with physicians setting the right expectations and will provide tools to help ensure patients have successful treatment experience, we will launch a new vitiligo app along with other tools designed to help patients to track their treatment and response.

As well as provide appointment reminders, which we expect to have a positive impact on patient adherence and of course, we will continue to provide access to opt to lora with co pay assistance that can lower co pays to as low as $10 a month.

We see this launching Lego is one of the largest opportunities for our franchise. We are starting with a very good label and we have heard from patients and advocacy groups around the country. There is a large established medical need this together with the momentum from the launch in a D will support a very successful launch.

Moving on to Jakafi on Slide 14, Jakafi net sales in the second quarter grew 13% year over year to $598 million total patient demand grew across all indications and the growth in new patient starts continues to remain above pre pandemic levels.

Gvhd patient growth of 18% year over year was driven mainly by the launching in the chronic setting with strong demand for Jakafi. We are again raising the bottom end of our Jakafi full year net product revenue guidance from 233 billion to a new range of $2 36 to 2.4.

$4 billion.

Turning to slide 15, and UV net product sales in the U S grew to $23 million in the second quarter with more use moving into the second line setting and a gradual improvement in duration men Judy net sales were $4 million.

We're at the launches ongoing in Germany and share in second line continues to increase.

<unk> worldwide net sales were $19 million with a launch currently ongoing in Europe and Japan.

With that I'll turn the call over to Steven.

Thank you Barry and good morning, everyone.

OLUMIANT was approved as the first and only systemic treatment for alopecia areata in the U.S., Europe, and Japan.

It sounded like you said that prescription, data was overestimated in a second.

That does conclude today's teleconference webcast.

And TABREKTA received European approval for a subgroup of patients with non-small cell lung cancer.

You may disconnect your line at this time and have a wonderful day.

We are making significant progress within our dermatology pipeline as you know <unk> received FDA approval in vitiligo, a few weeks ago and has now obtained two important FDA approvals in less than a year.

We will continue to pursue other indications that may expand the use of <unk> cream to more patient populations in need.

Additionally, we are developing an oral JAK one inhibitor <unk>, formerly Incb 54707 in hidradenitis Super Tivo, Vitiligo and <unk> all of which are in phase III and as I mentioned earlier, we are preparing a phase III in higher Ed or not.

Super Tvs.

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

One of the interesting studies, we are doing with racks lithium cream is a long term extension of the true <unk> studies, where we are evaluating the duration of response following the withdrawal of <unk>.

On the left you can see the study design with the true <unk> studies.

At 24 weeks after the primary endpoint has been reach patients could roll over into the long term extension study with an additional 28 weeks.

At 52 weeks patients who achieved at least a facial <unk> 90 response are then randomized one to one to receive one 5% racks lithium green B I D or vehicle.

And when I look at your growth sales, it looks like they declined slightly from 91 in the first quarter.

Additionally, those patients who did not achieve at least the facial <unk> 90 response at 52 weeks are maintained on therapy with one 5% rux cream B I D.

The primary endpoint of the study is time to relapse and those you are placed on vehicle with numerous secondary endpoints.

Just wondering, you know, how confident you are in those, forecasts?

Moving to slide 19.

We're announcing today the most recent compound moving into clinical development I N C. A three to 459 lag three PD one by specific antibody <unk>.

<unk> hundred two for $5 nine has been shown to be superior to independent lag three and PD one blocking in a lag three PD, one joule receptor assay and as increased cellular activity compared to a combination of the monoclonal antibodies.

Additionally, in a humanized mouse model for five nine controls tumor growth better than the combination and gives us confidence that it may provide differentiated pharmacology and the clinical profile relative to current treatments.

On the next slide we have a number of opportunities within limbo to expand our leadership in mpls and gvhd with multiple programs, reaching important milestones in the second half of 2022 and into 2023.

The NDA was accepted by the FDA for QD Rux <unk> and later this year, we expect initial data from the bet and L. Two programs in combination with rux lithium and we plan to start a phase <unk> program evaluating the combination of CK 080 for an <unk> in myelofibrosis.

Together, these approvals provided insight with 130 million of milestone revenues and will contribute with royalties to our future revenue growth.

Yeah, so our script data is very accurate. Obviously, we know exactly how much we're shipping.

We thank you for your participation today.

Finally, looking at some of the additional highlights of our pipeline on slide 7, POVERCITINIB, formerly known as 707, is now in preparation for a phase 3 study in H.S. following the positive results from our phase 2 trial.

The second quarter was a very successful quarter for inside with multiple product and partner product approvals and we look forward to a busy second half of the year.

As part of the Limburg program, IND clearance was received for CK0804, Celenco's cord blood, derived T-Rex cells, as add-on therapy to roxalitinib for the treatment of myelofibrosis.

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

We also received FDA clearance, FDA acceptance of the NDA submission for QD-roxalitinib, with a PDUFA date of March 23rd.

We know what we've reported.

Thank you Stephen and good morning, everyone.

And lastly, in early development, we expect to initiate a clinical program later this, year with 459, a LAG-3 PD-1 bispecific antibody developed in partnership with MERS.

Second quarter results reflect continued strong revenue growth with total product revenues of $664 million, representing an increase of 15% over the second quarter of 2021.

We have multiple ongoing studies across dermatology, Limburg, and hematology-oncology, as you can, see on the right, where each represents a meaningful opportunity and puts us in an excellent position for future growth and diversification.

The 867 data is what our wholesalers ship to the, pharmacies, which we think really reflects prescription volume.

Total product revenues are comprised of $598 million for Jakafi.

$50 million for other hematology oncology products and $17 million for upsell Laura.

Total royalty revenues for the quarter were $118 million and are comprised of $3 is from novartis of $84 million for jakafi and $4 million for contractor.

And royalties from Lilly of $30 million for alumina.

With that, I'll turn the call over to Barry.

Just getting to your last part, the demand in Q2 was actually higher than Q1. I believe it was 42,000 tubes in Q1 for demand and, 47,000 tubes in Q2 for demand.

Jacobean alumina in royalties for the quarter were negatively impacted by FX headwinds, while alumina and royalties were also impacted by a decrease in net product sales of ILUVIEN for use as a treatment for COVID-19.

Finally, total revenues for the quarter relative to $911 million or 29% increase over the prior year period as a result of the growth in product revenues as well as 130 million in milestone revenues related to the multiple partner product approvals achieved this quarter.

Turning to <unk>, we recorded gross product sales of $89 million in the second quarter.

Payoffs had I will tell you that the formularies, we are continuing to see improvement in the gross to net discount rate.

Thank you, Herve, and good morning, everyone.

So the difference in the growth sales that we reported last time and, this time is really an inventory issue. So inventory was lower at the end of Q2 than we anticipated. So that's really the difference there.

The fully loaded gross to net discount rate decreased from 86, 6% in the first quarter of 2020% to 281% in the second quarter of the year, leading to net product sales for the quarter of $17 million.

Starting with Opsalora, the launch in atopic dermatitis continues to be strong, and we, are very pleased with the progress that we have made across a number of important metrics. To date, over 10,000 physicians have prescribed Opsalora, with new writers being added each, week. Physicians continue to report a high level of satisfaction with Opsalora, with 67% stating, that they are highly satisfied, up from 46% earlier this year.

So we're very confident.

As you can see on slide 25, the evolution of the actual gross to net discount rate in Q2 represented by the Green line continues to be very much on track with our forecast with showed you and everything here.

Additionally, in a recent poll, physicians indicated nearly half of their AD patients, would be appropriate candidates for Opsalora, up from 37% earlier this year.

Now, what we've talked about TRXs, that's IQVIA TRXs.

Efficacy, including rapid itch reduction, as well as tolerability and the ability to, use Opsalora in sensitive areas remain the key product attributes, and we expect these attributes to continue to drive demand for Opsalora in AD.

We expect the gross to net discount rate to continue to decline in the second half of the ear and normalize at the fully loaded rate of 40% to 50% by the end of the year.

During the slide 10, earlier this month, we announced that we now have signed contracts, with the largest, with the three largest PBM GPOs, an outstanding achievement 10 months into launch, and a key step towards reaching our steady state gross to net goal. The contract with the third PBM became effective July 1st, and individual plans will now be, adding Opsalora to their formularies.

The charts shown on this slide is our internal 867 data, which is the number of Opsalora, units shipped from wholesalers to pharmacies.

With regards to IQVIA data, there has been an increased variability with the data in, recent weeks.

There is a misalignment that often happens with the products that, IQVIA sells, particularly at the beginning of a launch.

Moving onto our operating expenses on a GAAP basis ongoing R&D expenses of $344 million for the second quarter increased 2% from the prior year period, primarily due to the continued investment in our late stage development assets.

The overall trend shown by IQVIA data is representative of the actual kinetics, however, the number, of filled prescriptions, as reported by IQVIA, are being overprojected.

And they happen to be, and this is the data obviously, that you guys get, other analysts and investors get.

SG&A expense for the second quarter of $253 million increased 50% from the prior year period. The growth was primarily due to our investments related to the new dermatology commercial organization in the U S.

It is important to take away from this slide a couple of points, both on Q2 performance, and on recent trends. In the second quarter, as NDC blocks were removed and Opsalora was added to formularies, pharmacists and dermatologists began to shift from the process of the free drug program to going through the formulary process. This shift has two different effects.

One is a temporary delay of filled prescriptions, which you saw in the second quarter, and two, is the positive impact on covered claims, the benefit of which will be more pronounced beginning in Q3.

And the related activities to support the launch of accelerate in atopic dermatitis and prelaunch activities for vitiligo.

Our collaboration loss for the quarter was $3 million, which represents our 50% share of the U S. Net commercialization loss for one Julie.

Finally, we ended the quarter with $2 $7 billion in cash and marketable securities.

We are already seeing a return of 867 demand to within the range of our highest point since launch.

So, you know, it worries us a little bit when they're over-projecting.

Moving onto our guidance for 2022 as a result of our strong second quarter performance, we are tightening again.

Additionally, the percentage of covered claims, as shown by the red line, has risen rapidly from the mid-20% range at the end of June to nearly 55% today.

We work with IQVIA and they will, in fact, at, some point, make the corrections as they often do and they go back and send out to their customers what they believe the real data is today.

We anticipate with the combined effect of an increased number of filled prescriptions and improving gross net, Opsalora will have a more meaningful contribution to net sales in the second half of this year.

Jack if I got that range from 2.33 to $2 $4 billion to a new range of 2.3 seeks to $2.4 billion.

So we're very confident about our data.

We are also reaffirming our other and mythology oncology revenue Cogs, R&D and SG&A guidance for the year.

On slide 11, we're turning to vitiligo.

We're very confident that now, week after week, as it was in the beginning of the year,

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

This slide captures some of the highlights from Opsalora's FDA-approved label as the first treatment for repigmentation in vitiligo.

prescriptions will continue to grow from this point on and I don't anticipate any barriers to demand growth going forward.

This is a historic approval for patients living with this disease, and the approved label includes a number of important points that will help to drive the success of the product in this indication.

Okay, super helpful.

Opsalora is approved for patients 12 years of age and older and can be applied to affected areas up to 10% BSA.

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

<unk> Star one one moment, please while we poll for questions. Our first question is coming from Celgene Richter from Goldman Sachs. Your line is now live.

And then there was another topical approved yesterday in the dermatology space that could enter the AD market next year, and the WAC price was at a significantly lower than what we're up to today's price, and I was just wondering how you think that might, you know, impact competitive dynamics longer term.

So that was their decision, but we're confident in the way we priced our drug, and we're confident that both of these drugs that have recently been approved for plaque psoriasis will not equal the efficacy that we've demonstrated in our two phase three trials thus far.

The label allows for continuous use of Opsalora anywhere on the body, including sensitive areas, with no limit on duration of use.

Super helpful.

Good morning, Thanks for taking my questions two from me here.

The 52-week efficacy data, which has been included in the label, demonstrates the continued improvement in repigmentation with longer duration of treatment.

Thanks so much.

How do you know that <unk> is not driven by more organic demand that you ship from free drug versus reimbursement dynamics and then secondly for the drug in vitiligo could you just speak to the education required around time to onset of effect. So that patients do not expect an immediate improvement.

Sure.

You know I think the well what we're saying about the revenue is really it was mostly a our gross to net situation that the Kristina pointed out that that's what we forecasted in the beginning from Q1 to Q2 is consistent where our gross to net was going to be and then our demand as you see in the sort of middle of the quarter, we ran into a little bit of.

Hum.

A bump in the ER and the demand when we switched from the free drug program to the <unk>.

Two are fully covered for patients that are covered under.

The contracts that we signed and as you can see and that's why we show you. The graph on slide 10 is that are we believe that we've overcome these situations that we have most of the MDC blocks removed there continuing to be removed as we move into.

The third quarter here and it will only get better but our last week of demand was in fact, the biggest week of demand that we had in the last week of July and we believe that that trend line for demand is going to continue.

A second question as far as the light goes maybe Steven.

Highlighting the importance of staying on therapy, the label also notes that a satisfactory patient response may require treatment with Opsalora for more than 24 weeks.

Sylvia. Thank you for asking the question you know I think if you go back to label. This is why it is so great to have the 52 week data incorporate in the label while unexpected because it's obviously not in a placebo randomized period to have it in was a really good win because we can educate within label now to what we're seeing and so just to read.

And lastly, Opsalora was well-tolerated with application site acne as the most common AE in 6% of the patients.

Turning to slide 12 for the launch in vitiligo.

Iterate in terms of the primary endpoint the facial bassi at 24 weeks and then at 52 weeks you see this continued absolute increase of another 20 percentage points in the primary endpoint from the 24 week end point to the 52 week endpoint talking to exactly what you were alluding to that there is this graph.

<unk> time to onset in terms of improvement in re pigmentation, and it's actually reflected multiple times in the label with the efficacy data with the dosing guidance that allowed continued use and with the statement that says you may have to wait you know upwards of 24 weeks or beyond to see improvement.

Remember, these are the same target physicians as with AD, where we'll be able to leverage our existing relationships with physicians and to be able to benefit from the high level of satisfaction and experience that many already have with Opsalora today.

Improvement. So we can use both the commercial channel in terms of promotional activities because it's within label and then obviously appropriate medical communication to continually educate both the treaters the physicians as well as patient advocacy groups et cetera. That's there is this continued improvement over time and it'll be.

Our launch is underway with a comprehensive multi-channel marketing campaign that will ensure broad and consistent reach to effectively drive awareness and, importantly, to educate physicians on Opsalora's mechanism of action, its impact on vitiligo, and its unique clinical profile.

To support the launch of Opsalora and vitiligo, from the patient perspective, we're focusing on raising awareness and providing best-in-class support.

We plan to build awareness and activate patients living with vitiligo through a strong presence on social media, print, and eventually TV.

We're also partnering with advocacy groups where there has been an enormous amount of excitement for Opsalora and vitiligo.

This will be the first treatment for repigmentation available for these patients, and the safety and efficacy profile has been proven in the largest randomized clinical trial in this setting.

It is important to drive patient adherence and compliance on Opsalora. This will, of course, begin with physicians setting the right expectations, and we will provide tools to help ensure patients have successful treatment experience.

We will launch a new vitiligo app along with other tools designed to help patients track their treatment and response, as well as provide appointment reminders, which we expect to have a positive impact on patient adherence.

And, of course, we will continue to provide access to Opsalora with copay assistance that can lower copays to as low as $10.

Very much part of our efforts across the whole spectrum involved in the dermatology program.

Thank you.

Thank you.

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

Our next question is coming from Kripa Deverakonda from Truist Security.

We see this launch in Bitligo as one of the largest opportunities for our franchise.

Hi, good morning, Thanks for taking my questions.

Your line is now live.

Hey, guys.

Thank you so much for taking my question.

With regards to your guidance of 40% to 50% gross to net by the end of this year I know you've talked about.

With the launch trajectory, thus far but you know what what are you feeling, particularly confident about what absolutely needs to happen for you to reach that target is it more penetration into formulary is it you know a strong launch for vitiligo out of the gate just help us try to understand how because you're still at 81%, which is definitely an and.

One question on Opsalur.

Prevent itself.

A steep climb to get you where you want to be and then secondly, I'm just wondering in the early days of the launch are you able to compare how scripts have been relative to the early days of when a deal with.

Just wondering, how long do you expect the co-pay assistance to continue?

Thanks.

So our tenancy and so to get to 40, 50% really we just take that from the contracts that we already signed so the rebates and fees that would have to pay.

That's really what's going to drive our gross to net our increased confidence in our net revenue it will be based upon demand. So we do truly see that we're going to get to this 40% to 50% gross to net.

By the end of the year, just because all of the.

A lot of the work is out of the way now utilization criteria has to be written as a downstream plans for many of these things, particularly for vitiligo, but theres no MDC, there's mostly know LTC blocks now more MDC blocks continue to be removed, but they all will be removed relatively soon.

And that'll take us to this this target that we've talked about but really it's going to be the the demand that we continue to see great enthusiasm around a D and certainly vitiligo hasn't even started yet now as far as their language well at versus a.

D. A D. As we've talked about before I mean, there's 30 million patients in United States that might have atopic dermatitis, we say that theres 5 million patients that arent in our treatable population. That's a whole lot of patients that were already seeking treatment in terms of vitiligo. We talk about 150 to 200000 patients that are actively seeking treatment.

Where theyre vitiligo, so there's far fewer patients. So you can imagine that are going to come in perhaps right away, but we do absolutely see demand out there when we talk to the adverse advocacy groups. When we talk to our patients when we talk to the dermatologists to treat these patients. The demand is there and then there is millions of patients beyond the patients who are actively seeking.

Treatment for vitiligo today that we think will re enter and go back to their dermatologists to seek treatment just because now there's something better that's going to be available. So we don't necessarily see that there's going to be a gigantic bone Oh list. Today, we do know that patients are coming in today and getting <unk>.

It's filled for vitiligo and getting it paid for but we don't really know how many at this point, but it will take a number of weeks to a number of months in fact for all of the plans to write the utilization criteria for vitiligo, but we have a great label and we think that's what's going to be put into the utilization criteria by the downstream plants.

We are starting with a very good label, and we have heard from patients and advocacy groups around the country there is a large established medical need. This, together with the momentum from the launch in AD, will support a very successful launch.

Thank you, Barry, and good morning, everyone.

And then on the chronic GVHD, it looks like the uptake is pretty strong.

Okay.

Thanks for this question is coming from Brian Abrams from RBC. Your line is now live.

Hi, Good morning, Thanks for taking my question also on <unk>.

We are making significant progress within our dermatology pipeline. As you know, Opsalura received FDA approval in vitiligo a few weeks ago and has now obtained two important FDA approvals in less than a year.

I was just wondering if this strong launch is due to a bolus of available patients?

Do you expect the growth to continue in a similar manner?

Where are you seeing up to Lora being placed on formularies and atopic term relative to your expectations I guess I'm wondering whether the slower growth in end user usage, because you're facing now facing prior authorizations and step at it or if it's just a matter of misquoting it temporary miss coating at the level.

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

One of the interesting studies we are doing with ruxolitinib cream is a long-term extension of the TRU-V studies, where we are evaluating the duration of response following the withdrawal of Opsalura. At 52 weeks, patients who achieved at least a facial VASI-90 response are then randomized one-to-one to receive 1.5% ruxolitinib cream BID or vehicle.

Additionally, those patients who did not achieve at least a facial VASI-90 response at 52 weeks are maintained on therapy with 1.5% ruxolitinib cream BID.

The primary endpoint of the study is time-to-relapse in those who are placed on vehicle with numerous secondary endpoints.

Moving to slide 19, we are announcing today the most recent compound moving into clinical development, INCA-32459, a LAG-3 PD-1 bispecific antibody. INCA-32459 has been shown to be superior to independent LAG-3 and PD-1 block-in in a LAG-3 PD-1 dual receptor assay and has increased cellular activity compared to a combination of the monoclonal antibodies. Additionally, in a humanized mouse model, 459 controls tumor growth better than the combination and gives us confidence that it may provide differentiated pharmacology and a clinical profile relative to current treatments.

On the next slide, we have a number of opportunities within Limba to expand our leadership in NPNs and GVHD with multiple programs reaching important milestones in the second half of 2022 and into 2023. The NDA was accepted by the FDA for QD-Ruxolitinib, and later this year we expect initial data from the BET and L2 programs in combination with Ruxolitinib, and we plan to start a Phase I program evaluating the combination of CK0804 and Ruxolitinib in myelofibrosis.

The second quarter was a very successful quarter for Insight with multiple product and partnered product approvals, and we look forward to a busy second half of the year.

The pharmacy as you transition from free drug and then I guess along those lines. It looks like you have another question on gross to net it looks like your expectation range for third quarter is somewhat broad I'm wondering if you could talk about maybe some of the puts and takes there and the degree to which this is gonna be where you went up.

I guess for third quarter will relate to <unk>.

Some of the formulary replacement elements from that third piece.

From the third P. B M that come online in July .

Sure Brian So our expectations are for where they're placed on formulary again, it's the utilization criteria that downstream plants.

End up putting into place for a D. So most of the plans can have one prior therapy or two prior therapies and at GCI or Tcs all of our contracts are written so that.

The downstream plans can take advantage of rebates by deciding to put it after one step or two steps, but most of them are just they're they're one step two step when we think that will evolve over time and only get better.

There theres not necessarily Miss coding at pharmacies, there certainly was a little bit of maybe an unexpected.

The slowdown that we believe is fixed now that when people were switching from the free drug program to the prior approvals it was easier for some pharmacies to continue to.

They get free drug rather than going through the prior approval process, but in this marketplace. Prior approvals are the norm and in fact dermatologist started used to doing prior approvals. All the time most of them are electronic prior approvals that occur very quickly and if not they might take one or two days.

To get through the prior approval process. So we did have a slowdown but it really picked back up again and I'm really proud of our market access team that was able to step in and solve these problems.

For the gross to net I might hand, it over to Cristina.

Hi, Brian regarding the rest of that as we showed you on slide 25, the shape of the car from Q2.

For the E Q4, the second half of the year can take various forms but we are confident that at the end of the year, we'll be getting at least 40% to 50% gross to net discount rate what would the impact the shape of that curve in the second half.

Is that how quickly the remaining plants food are.

I'll turn around formularies and the speed in which of the remaining NBC blocks get removed, but are absolutely show deal.

We feel very good with the progress that we have made and are at this point, we have 80% of our plants that are or 80% of patients that are covered commercial patients that are on their plants that are under.

And there was a three large pbms with whom we have contracts and over 50% of our prescriptions that currently are Colbert. So we are progressing well towards that 40% to 50% state is steady state rate by the end of the year.

Got it very helpful. Thank you.

I'd now like to turn the call over to Christiana for the financial update.

Also, any additional color you can provide on when we can see data from axitilumab, the Syndax collaboration?

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

Thank you, Stephen, and good morning, everyone.

Thank you so much.

The second quarter results reflect continued strong revenue growth with total product revenues of $664 million, representing an increase of 15% over the second quarter of 2021. Total product revenues are comprised of $598 million for Jacapai, $50 million for other hematology products, and $70 million for Opselura.

Oh, Hey, thanks for taking the question. So the limber program can you talk about the potential for myelofibrosis disease modification with all the different combinations of rux with T. I C K.

Total royalty revenues for the quarter were $118 million and are comprised of royalties from Novartis of $84 million for Jacavi and $4 million for Tabrecta, and royalties from Lilly of $30 million for Olumient. Jacavi and Olumient royalties for the quarter were negatively impacted by FX headwinds, while Olumient royalties were also impacted by a decrease in net product sales of Olumient for use as a treatment for COVID-19.

But bcl two.

And whether or not you've seen any preclinical or clinical evidence of fibrosis improvement with any of those combos. Thank you.

So I'll take the first part and hand the axitilumab question over to Stephen.

Jay It's Steven Thanks for your question.

So obviously the you know the endpoints in clinical trials to date have been on spleen volume reduction and then symptom improvement to give you you know what what you need for clinical benefit but people look at.

This as well and then are there other things like allele burden et cetera to get to the point you are talking about one of the issues with with reading fibrosis from bone marrow is is is sampling is into observer variability central confirmation et cetera with a grading.

It's not always very precise.

But you do sometimes you can get a sense of fibrotic improvement. So so to reiterate you know clinical benefit comes currently at least at a regulatory standard from the spleen volume reduction and symptom improvement and then you know disease modification as an underlying secondary endpoint.

In terms of the therapies you mention.

You know we'll have to see basically there is preclinical clues are certainly in for example in the bed program certainly in terms of the new effort with selling costs and the T regulatory cells that we use there from the umbilical cord that you can potentially have underlying disease.

Vacation, but ultimately it's the the clinical datasets that that'll prove that with our with pasta closer.

You know we've announced are the primary endpoints for both the first line and the sub optimal study in terms of spleen volume reduction and certainly in first line needing symptoms as well.

With L. Two the promise potentially also comes from what we want is underlying anemia improvement and then the ability to continue to dose rux at adequate levels to get maximum effect.

So that's mainly what's been look what's being looked at and again just to be repetitive. We will ultimately see so there are some preclinical clues that you can do underlying modification, but well wait to datasets.

Great. Thank you.

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

So co-pay assistance.

So there's a couple of different parts to that.

So as we launch the program, as many other companies do when they launch a new drug in this sort of marketplace, is that you pick up the full cost of the drug.

Hi, Thanks for taking my questions.

The fully loaded gross to net discount rate decreased from 86% in the first quarter of 2022 to 81% in the second quarter of the year, leading to net product sales for the quarter of $17 million.

Back to the gross to net on absolute or just doing some back of the envelope calculations. The graphs you showed I mean, it looks like the cupboard claims or are getting a gross to net.

As you can see on slide 25, the evolution of the actual gross-to-net discount rate in Q2, represented by the green line, continues to be very much on track with the forecast we showed you earlier in the year. We expect the gross-to-net discount rate to continue to decline in the second half of the year and normalize at a fully loaded rate of 40-50% by the end of the year.

Moving on to our operating expenses on a gap basis, ongoing R&D expenses of $344 million for the second quarter increased 2% from the prior year period, primarily due to the continued investment in our late-stage development assets.

SG&A expense for the second quarter of $253 million increased 50% from the prior year period. 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 Opselura in atopic dermatitis and prelaunch activities for PTLIGO.

Our collaboration loss for the quarter was $3 million, which represents our 50% share of the U.S. net commercialization loss for Monjuvi. Finally, we ended the quarter with $2.7 billion in cash and marketable securities.

Moving on to our guidance for 2022. As a result of our strong second quarter performance, we are tightening again our Jackify guidance range from $2.33 to $2.4 billion to a new range of $2.36 to $2.4 billion.

We are also reaffirming our other hematology-oncology revenue, COGS, R&D, and SG&A guidance for the year.

Maybe in the low to mid Forty's is that accurate and then based on that you is there any reason to expect the kind of plans that are coming online later in the year to be materially different in terms of the person that's associated with them than the ones that are online currently.

Operator, that concludes our prepared remarks.

Please give your instructions and open the call for Q&A.

Certainly.

Okay.

So.

So mark.

So.

The first part of your question I guess, what Youre, saying you are a Christian as determined by the overall.

The number of units that we sold and are obviously the amount of reimbursement, we're getting or payments, we're getting for that so.

Right now our gross to net as you as you can.

Can see is where we expect.

I expect it to continue to improve 55% of claims are being covered now every single day, that's going to get better and better gross to net at the end of the year of course is going to be in the range that we said so they're not material different.

Gross to net will be better for each tube that we sell by the end of the year. So you know.

We're very confident of.

The guidance that we've given so far in terms of gross to net and I'm very confident that our demand is going to continue to increase week after week, particularly now with the vitiligo approval as well as the <unk> approval.

It was a good month.

Two you have two ways to look at it I mean, you can look at it over the entire set of prescription over a period of time and that's the graph we have showings that over a given quarter. The gross to net for all of this prescription.

<unk> has been in the 81% on the improving.

We will be improving in Q3, and then you have.

The other aspect which is the.

Frontage of Cobra claim and when the claim is co verb.

Net price for or give them Jews that one tubes that this program is in fact very much in line with our targets that we have given for the frozen food Europe 42 is to go from.

Okay, that's very helpful.

And then maybe just on the pipeline just given the decision to move forward in hidradenitis.

The phase two data.

Internally this year or should we expect to see it and then.

As you go towards phase III, what's kind of given the safety labeling of the JAK class.

You know kind of what's the clinical profile that you think you need to be able to establish on the efficacy side in order to be a.

You know a good option for hidradenitis visions.

Yeah. Thank you Mark so the yes. The intention is to show the complete phase II proof of concept data set at a meeting this year. So you will see it in 2022.

We expect you know to be treated with JAK class labeling here because it is after all and an inflammatory condition.

Again these are patients with a lot of unmet need they tend to have high body mass indexes and you know.

Lot of abscess and nodules. So the profile we need to see you know there are numerous ways to measure it we looked at Epsilon nodule count we looked at this established a combination endpoint called high score scoring system that was used with the humira approval.

And then you know we'll work out with the regulatory agency, what's the best one to use for a phase III study and then you know there is a there's a reasonable placebo response rates here as well again, you'll see that when we show you. The full dataset. So you wont see a you know a large delta between the placebo and then the efficacy.

Fact, given that you're gonna have class labeling likely a black box because it is an inflammatory condition and you know we are confident in what we've seen thus far with the with.

With 707 in the same entity.

Thank you.

We will now be conducting a question-and-answer session.

Thank you. The next question today is coming from Evan <unk> from BMO capital markets. Your line is now live.

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Hi, guys. Thank you so much for taking my question. So I know earlier on the call you had mentioned some of the commercial dynamics that you saw during second quarter were temporary.

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How temporary they were and now that we're a month into the third quarter or have you seen some of these trends reverse and then looking ahead you know what the gross to net around 40% to 50% drops to Lora is that we should be expecting some twenty-three in 'twenty 'twenty four is that really the steady state kind of in the years beyond 2022. Thank you.

One moment, please, while we poll for questions.

Yeah. So.

Was it was a temporary.

Our first question is coming from Salveen Richter from Goldman Sachs.

We believe we had a problem mostly with you now.

The large portion of our prescriptions are filled by our independent pharmacies. So it took us a little while to work together with them to work out of them getting back to doing prior approvals, which they're very familiar with and and we're very confident that that was in fact, a temporary now the gross to net.

50% going forward in 'twenty, three and beyond we're certainly going to do everything we can to protect our gross to net as you know the pbms and payers will.

We will always come back and try to get more and more and more so we just keep on working to maintain that that gross to net because we think the value that this product offers is exceptional and we don't want to lose that value.

Okay, great. Thank you.

Thank goodness question today is coming from Michael Schmidt from Guggenheim Partners. Your line is now live.

Your line is now live.

Good morning.

Hey, Thanks for taking my questions I had another one on <unk>, just maybe talk about your confidence in our script data and the increasing demand in the third quarter. It sounded yet it sounded like you said that prescription data was overestimated in a second and when I looked at your grow.

Thanks for taking my questions.

Two for me here.

Sales it looks like that declined slightly from 91 in the first quarter. Just wondering you know how confident you are in those forecasts.

Yeah. So our script data is very accurate, obviously, we know exactly how much we're.

Were shipping a we know what we've reported the 867 data is what our wholesalers ship to the pharmacies, which we think really reflects prescription volume just getting to your last part the demand in Q2 was actually higher than Q1 I believe it was 42002.

In Q.

One for demand and 47000 tubes in Q2 for demand.

The difference in the gross sales that we reported last time and this time. It was really an inventory issue. So inventory was lower at the end of Q2 than we anticipated. So that's really it.

There.

So we're very confident right now what we've talked about T. R. X's that IQ via T. Our actions. So there is a misalignment that often happens with the products that I cubie ourselves, particularly at the beginning of a launch and they happen to be and this is the data obviously that you guys get other.

Our analysts and investors get so.

Whereas there's a little bit when there are over projecting I. If we've we work with <unk> and they will in fact at some point make the corrections and as they often do and they go back and send out to their customers. What they believe the real data is today. So we're very confident about our data and we're very confident that now we can.

After week as it was in the beginning of year prescriptions will continue to grow from this point on and I don't see I don't anticipate any barriers to demand growth going forward.

Super helpful.

And then there was another topic color proof yesterday in the dermatology space that could enter the a D market next year and the.

Black price was at a significantly lower than what where we're up to there is price and I was just wondering how you think that might you know impact competitive dynamics in all the time.

Well I don't know why.

Our akitas are priced.

If they do or anybody else does pricing, where we're confident in the value that we offer and that's the price now also refill Alaska.

At least the data they released so far in atopic dermatitis is not that impressive. So it didn't come near the efficacy and safety that ops Lora offers to 80 patients. So their approval is completely different indication plaque psoriasis.

So apparently it's a okay in plaque psoriasis and they have lots of competition. There. So maybe their price point is based upon both the systemic competition as well as the other topical competition. So that's you know.

That was their decision, but we're confident in the way we priced our drug and we're confident that both of these drugs that have recently been approved for.

A plaque psoriasis.

We will not equal the efficacy that we've demonstrated in our two phase III trials, thus far.

Super helpful. Thanks, so much.

Thank goodness question is coming from Cooper condo from two of Securities. Your line is now live.

On Opsalora, how do you know that 2Q revenue is not driven by lower organic demand as you shift from free drug versus reimbursement dynamics?

Hey, guys. Thank you so much for taking my question. One question on <unk>, just wondering how long do you expect the copay assistance to continue.

And then, secondly, for the drug and vitiligo, could you just speak to the education required around time-to-onset of effects, so that patients do not expect an immediate improvement?

And then on the chronic gvhd it looks like the uptake.

Is is pretty strong I was just wondering if the strong launch is due to a bolus of available patients do you expect the growth to continue in a similar manner and also any additional color you can provide on when we can see data from the <unk>.

Sure.

You know, I think the – well, what we were saying about the revenue really was mostly a gross-to-net situation.

Access to the mob this index collaboration thank you so much.

Christiana pointed out that that's what we forecasted in the beginning from Q1 to Q2, is consistent where our gross-to-net was going to be.

And then our demand, as you see in the sort of middle of the quarter, we ran into a little bit of a bump in the demand, when we switched from the free drug program to fully covered for patients that are covered under the contracts that we signed.

So I'll take the first part and then hand, the filling that impression over to Steven.

The co pay assistance. So there's a couple of different parts of that so as we launch the program as many other.

Companies do when they launch a new drug in this sort of marketplace is that you pick up the full cost of the drug. So we fully anticipate doing that we wanted to have a very generous program.

So that full buy down program essentially will be phased out over time, and it's being phased out even now.

But their copay card program to assist patients that have a high co pay will always be in place. So what we'll always do that plus even patients that have <unk>.

And as you can see, and that's why we showed you the graph on slide 10, is that we believe that we've overcome these situations, that we have most of the NDC blocks removed.

So we'll always do that.

They're continuing to be removed as we move into the third quarter here.

Plus, even patients that have, maybe they go through the prior approval process and they're denied through our Inside Cares program, they'll be able to make, they'll be able to get drug.

And it will only get better, but our last week of demand was, in fact, the biggest week of demand that we had in the last week of July. And we believe that that trend line for demand is going to continue.

Maybe they go through a prior approval process and they are denied through our inside cares program.

They'll be able to make there'll be able to get drug.

So in terms of GVHD, it's the chronic launch.

So we did have a bolus in 2021 that we talked about.

In terms of Gvhd, it's a chronic launch so we did have a bolus in 2021 that we've talked about we had expanded access program.

We had an expanded access program.

We switched our two or 300 patients over from the expanded access program for Gvhd, That's all gone and we continue to grow as we've demonstrated 18% year over year growth chronic as are we.

We acute and chronic steroid refractory gvhd.

Jakafi is the standard of care hands down and we're very proud of that.

Patients are getting a lot of benefit from Jakafi and they'll continue to get benefit we'll see continued growth there I think we've talked.

We switched 200 or 300 patients over from expanded access program to GVHD.

Talked about before how we divide up.

Gvhd and you can see that it's about 15% of our units going out on net sales of approximately 15%.

We expect that to continue to grow there's about 14000 chronic gvhd patients out there the prevalent population is about 14000.

The second question, as far as little eye goes, may be Steven.

That's all gone.

But the incident population is relatively small so it's a it's an exciting area that we're in we think acts until I Mab will build upon that our franchise that we have in chronic gvhd and I'll hand, the call over to Stephen now for thanks, Barry. Thanks for the question, Chris You know without partners index, the Agave studies.

Go in and is enrolling accident excellently it should complete enrollment this year and then we wait for the primary endpoint and will present the data in 2023. That's a registration directed study in third line chronic graft versus host disease with monotherapy exit till a map. In addition, we will start you know combination work with <unk>.

<unk> inhibitor, which is now gonna be Rex, let's nib.

And that'll be to get a safe dose and schedule and then we'll move that up the treatment paradigm look at earlier lines earlier settings with a non overlapping mechanism of action plus the likelihood that there's no overlapping toxicity makes it a potentially exciting combination so just to repeat data in 2023 on the pivotal.

Australian study, which has gone really well.

Salveen, thank you for asking the question.

And we continue to grow, as we've demonstrated, 18% year-over-year growth.

Thank you so much.

You know, I think if you go back to the label, this is why it's so great to have the 52-week data incorporated in the label, while unexpected, because it's obviously not in the placebo-randomized period.

We'll see continued growth there.

To have it in was a really good win, because we can educate within label now to what was seen.

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

I think we've talked about before how we divided up GVHD, and you can see that it's about 15% of our units going out.

Our net sales are approximately 15%.

Hi.

We expect that to continue to grow.

I was wondering if we could get some more color on who's prescribing Pops the war on the coupons.

There's about 14,000 chronic GVHD patients out there.

The prevalent population is about 14,000.

Are the majority of the prescribers the docs that have been detailed by your sales reps and then TV.

Has a breakdown.

The Copays and it has a fair number of patients have zero co pays and also those that have over $75 co pay as I was just wondering if those data points are accurate.

And then I probably should know this but is your patient assistance co pay offset part of the gross to net calculation and then lastly, do you have any data on your bathroom scripts for ones that are presented to the pharmacy, but mossville by the patient because of the co pay or a lack of coverage.

So, we can use both the commercial channel in terms of promotional activities, because it's within label, and then obviously appropriate medical communication to continually educate both the treaters, the physicians, as well as patient advocacy groups, et cetera, that there is this continued improvement over time.

But the incident population is relatively small.

That's a lot of questions, but I will try to answer them one at a time, so who's prescribing, so dermatologist and dermatologist offices are prescribing, but that's dermatologist physician's assistance and nurse practitioners of which there are many and they're prescribing theres. Some allergists, who are prescribing as well so that's a that's what.

And it will be very much part of our efforts across the whole spectrum involved in the dermatology program.

So it's an exciting area that we're in.

We think Axitilumab will build upon that franchise that we have in chronic GVHD.

And I'll hand the call over to Stephen now.

Thanks.

Theyre breakdown of co pays its sort of all over the place. We do expect you know an average co pay that that a patient might have once there.

Wednesday or a plan covers absolutely are either for a D where for vitiligo and could settle in somewhere around $40.

Unfortunately Ah at the beginning of the year. Many patients also have a deductible that they have to meet before they get to their co pay. So we are we picked that up as well and yes. Our co pay assistance is part of the growth in that that's a factor in our net sales. So any co pay that we pick up of course was removed, but it's relatively low compared to compare.

Two a full buy down or something like that.

And number of scripts turned away by patients due to go to co pays I don't know like I said, there shouldn't be any due to co pays because we'll help them to pick up their co pay if they have a co pay that is difficult for them to.

To afford.

But how many scripts are the people walk away from them because of that it.

It shouldn't be any to be honest with you and like we said we did have a little bit of a hiccup, there where a patient might have not been getting their prescriptions as fast as they should have or may have walked away because it was taking too long to get them filled we think we have that completely fixed now and theres always going to be.

Alums in this marketplace that we have in this health care system that we have of patients are running into barriers, but in fact, we do everything we possibly can to make sure those patients get a get the scripts that they need.

Thank you.

Thank you so much.

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

Next question is coming from Tahseen Ahmad from Bank of America.

Thank you.

Your line is now live.

Next question is coming from Andrew Berens from SBB Security.

Thanks for taking my question. So I just wanted to circle back on they absolutely are a physician survey that you showed them do you have any insight.

Hi.

Your line is now live.

Good morning.

There's no pun intended there.

The driver behind the increase in that proportion of.

C D patients that are considered candidates for the job and then also I'm, hoping you might talk a little bit about what SKU D and the potential positioning for that once approved Oh, sorry, assuming approval next year. Thank you.

Sure as far as the survey goes I mean, all that's really saying is that are you know.

When we first ask physicians.

You know what percentage of patients that they believe are eligible for obsolete and this was in fact in a D. A.

You gave a number but now that more and more have us they've seen the safety and efficacy that <unk> provides you know we have many.

Patients and physicians, who send in pictures of their up there eczema resolving a relatively quickly or very quickly because of the use so they're very excited about it so the more they get experience with it the dermatologist physicians nurse practitioners P. A's are the more they decide that this could.

It really help a greater number of patients than.

Than we imagined so I think that's only going to continue to increase.

Both for a D and for vitiligo as a as a dermatologist really see how are the efficacy and safety of this product for.

<unk> D. Oh, we're going to launching next year, how are we going to position US well you know we think that this a once a day versus twice a day is a very good option for many patients.

Across all of our indications obviously, the real reason that we're having a rock SKU D. Roll out is because we want to combine it with our other products that Stephen talked about before that we have in our pipeline that we think will add to the safety and efficacy.

Or the efficacy that Jakafi already provides so so that's the the real purpose of launching it but we think many people will benefit just from a convenience factor a better compliance that they'll get from a once a day versus twice a day.

Okay, if I could just ask one more of a statement.

Joe.

So that difference.

Body surface area criteria, and how that aligns with how physicians treat vitiligo.

Sure Andrew.

For vitiligo.

Sure Stephen Thanks for the question. So our current label with with <unk> in patients with 10% or less body surface surface area involvement, which incorporates about 80% of patients with non segmental vitiligo and for practical purposes, it gets pretty difficult to treat people with more.

<unk> surface area and will.

Because of the amount of cream potentially you have to use.

<unk> sitting in the Vitiligo program, there's a little bit of overlap and you know we work with regulators, it's 8% or above. So these are people with much more extensive skin involvement and they can go up to.

2030, 40% involvement and then again practically it becomes impossible to put that much cream on the therapeutic ratio changes and you can use an oral therapy to treat an oral systemic JAK inhibitor to treat the vitiligo because of that overlap the numbers can get a little confusing but that represents about.

30% of patients. So you can sort of do the math there that have you know more than more than 8% involvement and require an oral JAK inhibitor because of the extent of disease involvement there. Thanks.

Yeah.

Hi.

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

Thanks for taking my questions.

Thanks.

Good morning, Thanks for taking my questions I guess on the fixed on the QD Rux and then the but the data come in as the next step after we see the data in the second half to move right to a fixed dose combination.

I was wondering if we could get some more color on who's prescribing Opsalur and the co-pays.

With regards to your guidance to 40% to 50% growth to net by the end of this year, I know you've talked about, you know, you're happy with the launch trajectory thus far, but, you know, what are you feeling particularly confident about?

With the QD rux or is there an additional.

These two trials are something that will happen.

And then separately Judy I'm just wondering if you still see this as a 500 to 700 million opportunity given the rollout and in particular the broader label of Realogy to include transplant ineligible patients if that impacts your kind of long term opportunity for bolt Judy.

You might see and I'll do the first part so because it's you know it's once daily and it was at in a submission that involve bio equivalence and bioavailability data to get there.

We'll be developing other clinical data, but at the same time, we've started developing fixed dose combinations because all of our other combinations of once daily as well so whether it's past the close of the bet inhibitor <unk> two inhibitor. They all once daily and have the ability to have fixed dose combinations the pasta closer.

Registration studies are obviously ongoing and enrolling well both the sub optimal in the first line study and obviously aren't with fixed dose combinations at the moment. So once we have an FTC. There we would work out of the transition again likely through a b a b E route in conjunction with regulators to get there, but the future programs.

Should we go there with personnel too would have the potential to go straight away to an FTC with each of those so that's the promise there and then I'll hand, the question over to others.

So Judy.

Yeah, we certainly we certainly still have confidence in my Juvie, we certainly still think that we're going to get to a in the relapsed refractory setting we can get to $500 million, obviously, its taken us longer than I than we anticipated you know the marketplace has changed in diffuse large b cell lymphoma over time, it's a very dynamic market.

There's more data with the car Ts, there's more data with frontline.

I believe he there's more there's.

As more products entering that.

Specifics, but my Juvie and Len is an excellent combination for patients who have failed R. Chop therapy. Her relapsed on R. Chop and we really believe that there's really only a couple of options for patients who aren't going on to transplant and that could be car T. <unk>.

The vast majority of patients should be eligible for mine Judy land. So we just need to keep on doing a better job of educating because this is a product that really has a great.

CR rate and the duration of response is 44 months, a three year follow up and Theres really not a much better data or any better data in that particular setting for duration of response.

Then on JV land so are.

We really anticipate that this is a product that can serve a lot of patients in the <unk>.

Relapsed refractory setting and then of course, well wait for data in Follicular lymphoma and in the first line setting because that's where the ultimate real value of the product will come from.

What absolutely needs to happen for you to reach that target?

Are the majority of the prescribers the docs that have been detailed by your sales reps?

Yeah.

The next question is coming from Stephen Willey from Stifel. Your line is now live.

Is it more penetration into formulary?

And then Akevia has a breakdown of the co-pays, and it has a fair number of patients that have zero co-pays, and also those that have over $75 co-pays.

Yeah. Good morning, Thanks for squeezing me in so just a quick one on obsolete. So I guess following the initial approval in a D. I know your guidance implied about three to four tubes for 80 patients per year in <unk>.

Is it, you know, a strong launch for vitiligo out of the gate?

I was just wondering if those data points are accurate.

Just help us try to understand how, because you're still at 81%, which is definitely an improvement, but still, you know, a steep climb to get to where you want to be.

And then secondly, for vitiligo, I'm just wondering, in the early days of the launch, are you able to compare how scripts have been relative to the early days of when AD was launched?

Just wondering how the reorder rate that you're seeing at this point of the launch doing forms you know some of the persistency and utilization assumptions are.

That are embedded within that Oh that you that guidance on a on a per patient basis. Thanks.

Yes, Stephen's Barry so.

Until we really see all of the M. D C blocks removed the utilization criteria stabilize it's really hard to know exactly what the refill rate is currently in is going to be in the future for E D.

So these patients we know that a 25% of the daily 27% of our units are.

This quarter were from refills is that the right amount or is it going to be more than that it's hard to say at this point until we get fully stabilized on the payer situation. Once we do then we'll really see what the refill rate is going to be the drug works really well.

Some patients get relief very quickly and some patients will have to have that.

I'll have flowers, we know that from our clinical trials and have to come back for a refill again, so it's not clear at this point, but like I said, 27% of our units currently and.

May grow into the future, but well we'll have to get some more data before we can.

Finalize that number.

Alright, thanks for taking the question.

Thanks.

And I probably should know this, but is your patient assistance co-pay offset part of the gross to net calculation?

Thank you. Our final question today is coming from Kevin Clark partner from Evercore ISI. Your line is now live.

So, Tanzeen, so to get to 40% to 50%, really, we just take that from the contracts that we already signed.

And then lastly, do you have any data on the abandoned scripts, the ones that are presented to the pharmacy, but not filled by the patient because of the co-pay or lack of coverage?

So the rebates and fees that we have to pay, that's really what's going to drive our growth to net.

Our increased confidence in our net revenue, it will be based upon demand.

So we do truly see that we're going to get to this 40% to 50% growth to net by the end of the year, just because a lot of the work is out of the way.

Now, utilization criteria has to be written as a downstream plan for many of these things, particularly for vitiligo.

But there's mostly no NDC blocks now. More NDC blocks continue to be removed, but they all will be removed relatively soon, and that'll take us to this target that we've talked about.

That's a lot of questions, but we'll try to answer them one at a time.

But really, it's going to be the demand that we continue to see great enthusiasm around AD, and certainly vitiligo hasn't even started yet.

Hey, Thanks for taking the question. So just on the Limber program for the two phase II combination data that's coming in the second half of this year could you just help with some expectations for what data exactly we'll see but I know you mentioned it'll be the initial and somewhat limited efficacy data, but just wanted to clarify what exactly you are planning to show. Thanks.

Now, as far as vitiligo versus AD, AD, as we've talked about before, I mean, there's 30 million patients in the United States that might have atopic dermatitis.

We say that there's 5 million patients that are in our treatable population.

That's a whole lot of patients that were already seeking treatment.

So who's prescribing?

In terms of vitiligo, we talk about 150,000 to 200,000 patients that are actively seeking treatment for their vitiligo.

So dermatologists and dermatologist offices are prescribing, but that's dermatologists, physicians, assistants, and nurse practitioners, of which there are many, and they're all prescribing.

Hey, Gavin Stephen Thanks.

So there's far fewer patients that you can imagine that are going to come in perhaps right away.

There's some allergists who are prescribing as well, so that's what's happening there.

But we do absolutely see demand out there. When we talk to the advocacy groups, when we talk to our patients, when we talk to the dermatologists who treat these patients, the demand is there.

Breakdown of co-pays, it's sort of all over the place.

So they it'll it'll Europe , you're correct, it's actually mostly phase one safety data, but we'll try and incorporate as much of the efficacy component as we can in time for the abstract cutoff et cetera.

And then there's millions of patients beyond the patients who are actively seeking treatment for vitiligo today that we think will reenter and go back to their dermatologist to seek treatment just because now there's something effective that's going to be available.

We do expect an average co-pay that a patient might have once their plan covers Opsalara, either for AD or for vitiligo, and it could settle somewhere around $40.

So we don't necessarily see that there's going to be a gigantic bolus today.

Unfortunately, at the beginning of the year, many patients also have a deductible that they have to meet, before they get to their co-pay, so we pick that up as well.

We do know that patients are coming in today and getting strips filled for vitiligo and getting it paid for.

And yes, co-pay assistance is part of the gross net.

We don't really know how many at this point, but it will take a number of weeks to a number of months, in fact, for all of the plans to write the utilization criteria for vitiligo.

That's a factor in our net sales.

Any co-pay that we pick up, of course, is removed, but it's relatively low compared to a full buy-down, or something like that.

And number of scripts turned away by patients due to co-pays, I don't know.

Like I said, there shouldn't be any due to co-pays because we'll help them to pick up the co-pay, if they have co-pay that is difficult for them to afford.

But how many scripts did people walk away from because of that?

It shouldn't be any, to be honest with you.

Like we said, we did have a little bit of a hiccup there where patients might have not been getting, their prescriptions as fast as they should have or may have walked away because it was taking too long to get them filled.

We think we have that completely fixed now, and there's always going to be problems in this marketplace, that we have and this health care system that we have of patients running into barriers.

But we have a great label, and we think that's what's going to be put into the utilization criteria by the downstream plan.

But in fact, we do everything we possibly can to make sure those patients get the scripts that they need.

Our next question today is coming from Mara Goldstein from Mizzou.

And then for.

Thank you.

Your line is now live.

Again, just to mention briefly it's a drag we had for a long time, we treated solid tumor patients at multiples of the dose years ago, and you know hundreds plus patients. So we know its safety profile at higher doses very well in terms of on target thrombocytopenia and now it's really about getting the right therapeutic ray.

Thank you.

Oh, thanks for taking that question.

<unk> in combo with Rux, and then make decisions to go forward. So it's largely a safety update to some efficacy on how to incorporate some translational data as well, particularly as regards.

Our next question is coming from Brian Abrams from RBC.

So I just wanted to circle back on the Opsalora Physician Survey that you showed.

Your line is now live.

Do you have any insight, I guess no pun intended there, as to the driver behind the increase in that, proportion of treated patients that are considered candidates for the drug?

Hi, good morning.

And then also I'm hoping you might talk a little bit about RUX QD and the potential positioning for that, once approved or assuming approval next year.

Thanks for taking my question.

Also on Opsalora, where are you seeing Opsalora being placed on formularies in a topic term relative to your expectations?

I guess I'm wondering whether the slower growth in end-user use is because you're now facing prior authorizations and step edits, or if it's just a matter of temporary miscoding at the level of pharmacy as you transition from free drug.

Along those lines, it looks like your expectation range for third quarter is somewhat broad.

I'm wondering if you could talk about maybe some of the puts and takes there, and the degree to which this is going to be where you end up, I guess, for third quarter will relate to some of the formula replacement elements from the third PBM that got online in July.

Thanks.

Sure, Brian.

And kinetics and hip sodden inhibition, so youll see that as well in the data set that is presented and we've seen favorable movements in terms of Epsilon inhibition and some on kinetics, but we'll have to see whether that translates to hemoglobin increases or not.

So our expectations are for where they're placed on formula.

Again, it's the utilization criteria that downstream plans end up putting into place for AD.

So most of the plans can have one prior therapy or two prior therapies at TCI or TCS.

Hi, Brian.

Regarding the gross to net, as we showed you on slide 25, the shape of the curve from Q2 to Q4, the second half of the year, can take various forms, but we are confident that at the end of the year, we'll be getting at least 40 to 50% gross to net discount rate. So we are progressing well towards that 40 to 50% steady state rate by the end of the year.

Got it.

Your line is now live.

Thank you.

Very helpful.

Oh, hey.

Sure.

Thank you.

Thanks for taking the question.

As far as the survey goes, I mean, all that's really saying is that, you know, when we first asked physicians, you know, what percent of patients that they believe are eligible for Opsalora, and this was in fact in AD, you know, they gave a number.

Thank you.

For the Limber Program, can you talk about the potential for myelofibrosis disease modification with all the different combinations of RUCs with PI3K, ALK, BAT, BCL2, and whether or not you've seen any preclinical or clinical evidence of fibrosis improvement with any of those combos?

But now that more and more have used, they've seen the safety and efficacy that Opsalora provides.

Next question is coming from Jay Olson from Oppenheimer.

Thank you.

You know, we have many patients and physicians who send in, pictures of their eczema resolving relatively quickly or very quickly because of the use, so they're very excited about it.

Jay, it's Steven.

So the more they get experience with it, the dermatologists, physicians, nurse practitioners, PAs, the more they decide that this could really help a greater number of patients than we imagined.

Thanks for your question.

So I think that's only going to continue to increase both for AD and for vitiligo.

So, obviously, the endpoints in clinical trials to date have been on spleen volume reduction and then symptom improvement to give you what you need for clinical benefit.

As dermatologists really see how the efficacy and safety of this product.

One of the issues with reading fibrosis from bone marrows is sampling, is inter-observer variability, central confirmation, et cetera, with a gradient is not always very precise.

For Rux QD, you know, we're going to launch it next year.

But you do sometimes you can get a sense of fibrotic improvement.

How are we going to position it?

So, to reiterate, clinical benefit comes currently, at least at a regulatory standard, from the spleen volume reduction and symptom improvement and then disease modification as an underlying secondary endpoint.

Evan Seigerman from BMO Capital Market.

Well, you know, we think that this, you know, once a day versus twice a day is a very good option for many patients.

It's actually mostly Phase 1 safety data, but we'll try and incorporate as much of the efficacy component as we can in time for the abstract cutoff, etc.

In terms of the therapies you mentioned, you know, we'll have to see, basically.

Your line is now live.

So that's the real purpose of launching it, but we think many people will benefit just from the convenience factor, the better compliance that they'll get from a once a day versus a twice a day.

And then, you know, for, again, BET, just to mention briefly, it's a, it's a drug we've had for a long time.

So largely safety updates minimal efficacy some translational data felt too thanks.

There is preclinical clues, certainly in, for example, in the BET program, certainly in terms of the new effort with silencos and the T regulatory cells that we use there from the umbilical cord that you can potentially have underlying disease modification.

Hi guys.

Okay.

We treated solid tumor patients at multiples of the dose years ago, and, you know, hundreds plus patients.

But ultimately, it's the clinical data sets that will prove that.

Thank you so much for taking my question.

And if I could just ask on Cervicitinib and vitiligo, can you just speak to that difference in the body surface area criteria and how that aligns with how physicians treat vitiligo or current standards of care for vitiligo?

So, we know its safety profile at higher doses very well in terms of on-target thrombocytopenia, and now it's really about getting the right therapeutic ratio in combo with RUX and then make decisions to go forward.

With parseclusive, you know, we've announced the primary endpoints for both the first line and the suboptimal study in terms of spleen volume reduction and certainly in first line needing symptoms as well.

So I know earlier on the call you, had mentioned some of the commercial dynamics that you saw during second quarter were temporary.

Sure, Stephen.

So, it's largely a safety update to some efficacy.

With L2, the promise potentially also comes from what we want is underlying anemia improvement and then the ability to continue to dose RUCs at adequate levels to get maximum effect.

I'm just wondering how temporary they were and now that we're a month into the third quarter.

Thanks for the question.

On L2, it incorporates some translational data as well, particularly as regards iron kinetics and hepcidin inhibition.

So, that's mainly what's been looked at.

Have you seen some of these trends reverse?

So our current label with Opsalura is in patients with 10% or less body surface area involvement, which incorporates about 80% of patients with non-segmental vitiligo.

So, you'll see that as well in the dataset that's presented.

Thank you.

Thank you.

And again, just to be repetitive, we'll ultimately see.

And then looking ahead, you know, with the, growth center on 40 to 50 percent for Opsalura, is that what we should be expecting come 2023 and 2024?

Because of that overlap, the numbers can get a little confusing, but that represents about 30% of patients.

And, you know, we've seen favorable movements in terms of hepcidin inhibition and some iron kinetics, but we'll have to see whether that translates to hemoglobin increases or not over time.

We've reached the end of our question and answer session.

So, there are some preclinical clues that you can do underlying modification, but we'll await the data sets.

Is that really the steady state kind of in the years beyond 2022?

So you can sort of do the math there that have more than 8% involvement and require an oral Jack inhibitor because of the extent of disease involvement there.

So, largely safety updates, minimal efficacy, some translational data for L2.

Okay.

Thanks.

Thanks.

Thanks.

Sounds great.

Thank you.

Thank you.

Thank you.

As a reminder, that's star one to be placed into question Q.

Next question is coming from Matt Phipps from William Blair.

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

Our next question today is coming from Mark Fromm from Cal, and your line is now live.

Your line is now live.

Hey, thanks for taking my questions.

Good morning.

Just back to the gross to net on Opsalura, just doing some back of the envelope calculations with the graph you showed.

Thanks for taking my questions.

I mean, it looks like the covered claims are getting a gross to net.

I guess on that fixed, on the QD-RUX and then the, BET-MILK data coming, is the next step after we see the data in the second half to move right to a fixed dose combination with the QD-RUX or is there an additional phase two trial or something that will happen?

That's maybe in the low to mid 40s.

And then separately, on Monjuvie, I'm just wondering if you still see this as a 500 to 700 million opportunity given the rollout and in particular the broader label of Brionzi to include transplant ineligible patients, if that impacts your kind of long-term opportunity for Monjuvie?

Is that accurate?

Yeah, Matt, I'll do the first part.

And then based on that, is there any reason to expect the kind of plans that are coming online later in the year to be materially different in terms of the gross to net that's associated with them than the ones that are online currently?

So because it's, you know, it's once daily and it was in a submission that involved bioequivalence and bioavailability data to get there, you know, we will be developing other clinical data.

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.

So, Marc, so, you know, the first part of your question, I guess what you're saying, you know, our gross net is determined by the overall number of units that we sold and obviously the amount of reimbursement we're getting or payments we're getting for that.

But at the same time, we've started developing fixed dose combinations because all of our other combinations are once daily as well.

So, you know, we're very confident of the guidance that we've given so far in terms of gross net, and I'm very confident that our demand is going to continue to increase week after week, particularly now with the vitiligo approval as well as the AD approval.

So whether it's parciclisib, the BET inhibitor or the L2 inhibitor, they're all once daily and have the ability to have fixed dose combinations.

And then you have the other aspect, which is the percentage of covered claims. And when the claim is covered, the net price for a given tube, that one tube that is covered, is, in fact, very much in line with our target that we have given for the full year, 40 to 50 percent.

The parciclisib registration studies are obviously ongoing and enrolling well, both the suboptimal and the first-line study, and obviously aren't with fixed dose combinations at the moment.

Okay, that's very helpful.

So once we have an FDC there, we would work out a transition, again likely through a BABE route in conjunction with regulators to get there.

And then maybe just on the pipeline, Stephen, the decision to move forward in hydrogenitis, is the Phase 2 data just available internally this year, or should we expect to see it?

But the future programs, should we go there with BET and L2, would have the potential to go straight away to an FDC with each of those.

And then as you go towards Phase 3, what's kind of, given the safety labeling of the JAK class, you know, kind of what's the clinical profile that you think you need to be able to establish on the efficacy side in order to be a good option for hydrogenitis patients?

So that's the promise there.

Yeah, thank you, Mark.

And then I'll hand the question over to others for the second part.

So, yes, the intention is to show the complete Phase 2 proof of concept data set at a meeting this year, so you will see it in 2022.

Yeah, so Monjuvi, we certainly still have confidence in Monjuvi. We certainly still, think that we're going to get to, in the relapse refractory setting, we can get to $500 million. Obviously, it's taken us longer than we anticipated.

And then, you know, there is a reasonable placebo response rate here as well.

You know, the marketplace, has changed in diffuse large B-cell lymphoma over time.

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

Again, you'll see that when we show you the full data set.

It's a very dynamic market.

So, you want to see, you know, a large delta between the placebo and then the efficacy effect, given that you're going to have class labeling, likely a black box because it's an inflammatory condition.

Obviously, there's more data with the CAR-T's.

And, you know, we're confident in what we've seen thus far with, you know, the placebo, with 707 in this entity.

There's more data with front-line Polivy.

Thanks.

There's more products entering that, you know, are the bispecifics.

Thank you.

But Monjuvi and LEN is an excellent combination for patients who have failed RCHOP therapy or relapsed on RCHOP.

Thank you.

And we really believe that, you know, there's really only a couple of options for patients who aren't going on to transplant, and that could be CAR-T.

The next question today is coming from

But the vast majority of patients should be eligible for Monjuvi LEN.

So we just need to keep on doing a better job of educating because this is a product that really has a great CR rate.

And the duration of response is 44 months, a three-year follow-up.

There's really not much better data or any better data in that particular setting for

duration of response than Monjuvi LEN.

So we really anticipate that this is a product that can serve a lot of patients in the relapsed refractory setting.

And then, of course, we'll wait for data in follicular lymphoma and in the first-line setting because that's where the ultimate real value of the product will come from.

Mike, the next question is coming from Steven Willey from Steve Feuerlein, he's now live.

Yeah, good morning.

Thanks for squeezing me in.

So, just a quick one on OPS Alert.

So, I guess, following the initial approval in AD, I know your guidance implied about three to four tubes per AD patient per year.

Just wondering how the reorder rate that you're seeing at this point in the launch still informs, you know, some of the persistency and utilization assumptions that are embedded within that unit guidance on a per patient basis.

Thanks.

So, it's not clear at this point, but like I said, it's 27% of our units currently and, you know, that may grow into the future, but we'll have to get some more data before we can finalize that number.

All right.

Thanks for taking the question.

Thank you.

Our final question today is coming from Gavin Clark-Gartner from Evercore ISI.

Your line is now live.

Hey, thanks for taking the question.

So, just on the LIMBER program, for the BET and ALK2 Phase 2 combination data that's coming in the second half of this year, could you start with some expectations for what data exactly we'll see?

So, I know you mentioned it'll be the initial and somewhat limited efficacy data, but just wanted to clarify, like, what exactly you're planning to show.

Thanks.

Hey, Gavin.

Stephen.

Thanks.

So, the, it'll, it'll, you're, you're correct.