Hello, and welcome to the Insight Corp Third Quarter 2020 Financial Results Conference Call. At this time, As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mike Booth, Head of Investor Relations at Insight. Please go ahead, sir.
Thank you, Kenneth. Good morning, and welcome to Insight's 3rd quarter 2020 earnings conference call and webcast. The slides used today are available for download on the Investors section of insight.com. I am joined on the call today by Herve, Barry, Steven and Cristiana, who will deliver our prepared remarks, and by Dash, who will join us for the Q And A session. And if needed, one follow-up as this will enable as many of you to ask questions as time allows.
Before we begin, I'd like to remind you that some of the statements made during the call today are forward looking statements, including statements regarding our expectations for 2020 guidance, the commercialization of our products and our development plans and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially. Including those described in our 10 Q for the quarter ended June 30, 2020, and from time to time in our other SEC documents. In addition, I would like to caution everyone that the COVID-nineteen pandemic is an evolving situation, and we may therefore be unable to assess the full effect of governmental business and social actions and policies and overall economic conditions on our business. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today.
We'll now begin the call with Abe.
Thank you, Mike, and good morning, everyone. In the third quarter, we saw continued strong growth within our commercial business and we progressed our clinical for you on both development and regulatory fronts. Commercial performance across the business was strong, Our product and royalty revenue grew 16 percent to $621,000,000, driven by Jakafi as well as an increasing contribution from new product launches and from royalties. Jakafi sales grew 13% year over year to reach 488,000,000 with growth seen across all three indications. Jakavi and Olumiant royalties grew 17 and 32% respectively, totaling nearly $100,000,000 in revenues for the quarter.
There is significant momentum in the 1st weeks of Montubi in the U. S, and I am pleased to say that Pema Zayer, Pema Dier, which was launched at the end of April, has outperformed our initial expectation. The application seeking approval of spafacitanab relapsed or refractory DLBCL is under review in Europe, an application seeking approval for Pemigatinib Colombio carcinoma, our under review in both Europe and Japan. It has been a busy quarter for baricitinib development update, exciting data were recently presented from the ongoing evaluation of baricitinib in patients with severe alopecia areata, And Lilly's development program in this indication includes 2 Phase III trials. If approved, Vaseline may be the first JAK inhibitor to be approved for alopecia areata.
And in October, baricitinib became the first oral JAK inhibitor indicated for the treatment of moderate severe atopic dermatitis, following its approval by the European Commission. This represents a new potential source of revenue for Incyte And with Lilly, we also announced positive data from the ACTT2 trial of bacitinib in COVID-nineteen. From our IO portfolio, positive results were presented from our trial evaluated RETifundymab in squamous cell anal carcinoma, and from our dermatology portfolio, we share positive preliminary efficacy and safety results for our oral JAK1 inhibitor 54707 in hidradenitis suppurativa HS. HS is a chronic skin condition caused by inflammation and infection of the sweat gland. We also presented full results from the Phase III through AD program of ruxolitinib cream in atopic dermatitis.
These results are indicative of why we are so excited by the potential of our dermatology portfolio and why we are establishing a new dermatology franchise for insights. Incyte has deep expertise in immunology within our drug discovery team, and we have leveraged our cross program knowledge of the JAK STAT password to develop innovative medicines to treat autoimmune disorder. We are now developing science based therapeutic the medical dermatology community and have multiple first in class candidates that we believe can deliver important benefits to patients. Our dedicated dermatology development group continues to execute with precision and speed as evidenced by the rapid month of rock screen in recent years, including the successful Phase III program in atopic dermatitis and the recent completion of recruitment into the pivotal Vitiligo program. We are also building our U.
S. Commercial organization. The expected acceleration of regulatory timelines through the use of the priority review voucher gives us added momentum here, and I'm very pleased to say that we have been able to recruit some exceptional talent as we continue to build our Dermatology team. I will end my introduction by reminding you of the tremendous progress we have made so far in 2020. We have announced multiple positive pipeline developments since the beginning of this year as shown by the check marks on Slide 6.
And looking forward, we have 5 important updates to come over the next 2 months. We expect to submit the NDA for ruxolitinib cream at end of year and to initiate the 1st Phase III trial in the Limber program. Important transactional data from 86,550, our oral PD L1 inhibitor is going to be presented at CITC next week and we are also expecting a busy ASH conference in early December. At ASH, our presentation will include an oral presentation of Zohrich, III data from roxellitinib in chronic GvHD as well as a series of updates from the PASAC disease citadel program several different non non skin lymphomas. And we also intend to host an investor call on Monday 7th December to provide our highlights from the conference.
I will now pass the call over to Barry for the commercial overview. Thank you, Herbe, and good morning, everyone.
In the 1st 9 months of 2020, Jakafi sales increased 17% versus the same period in 2019, and we continue to see good demand for Jakafi across all three indications. The continued strong performance in the year to date has enabled us to tighten our On the right hand side of of patients on Jakafi, but numbers of polycythemia vera and GVHD patients on Jakafi are increasing and now comprise 33% and 13% of total patients, respectively. Slide 10 provides additional color around new patient growth for Jakafi. The chart on left shows that over 90% of total patients are ongoing patients from prior periods, and this pool of ongoing patients continues to grow quarter over quarter. As we have previously disclosed, new patient starts were down significantly in Q2 this year.
As we felt the effects of COVID-nineteen due to total patient visits being down. Following this transient decline in Q2, there was a partial rebound in new patient start in Q3. Turning now to the Mondubi launch progress. We are very pleased with the performance of Mondubi generating $5,000,000 in the 1st few weeks since launch in mid August. With our colleagues at MorphoSys, the commercial and medical teams have been driving increased awareness of the benefits of manjubi, and we are now the market leaders in terms of share of voice.
Field activity, participation in educational presentations, and inclusion in the NCCN guidelines are all contributing to the increasing awareness of Monduvi within the hemonc community. Feedback thus far has been very positive with physicians highlighting the importance of ManjuVI's depth and duration of response and its favorable safety profile. We have built strong momentum for Monduvi within both the academic and community settings with greater than 200 accounts having now ordered, we are seeing a sizable uptake by hemonks in the community which now accounts for approximately 65 percent of total prescribers, a trend that we anticipated. Our market access team have also made significant strides since launch, achieving nearly 90% formulary approvals in our top 30 accounts. Turning to Pemazyr, which we launched in the second quarter.
We have been very pleased with the rapid adoption of this new medicine, this novel medicine with 8,000,000 in sales generated in the third quarter. Broad access to FGFR testing has contributed to this rapid patient adoption and we have seen good uptake of PEMAZIR nationally with over 200 patients treated since launch. A high refill written rate also suggests that the appropriate patients are being identified via this testing as they continue on PEMISER therapy. I'll now turn the call over to Steven for our clinical updates.
Thanks, Barry and good morning everyone. I'll start with our ruxolitinib cream program. Initial data from the phase 3 trials presented earlier this year at RAD, showed that ruxolitinib cream resulted in significantly higher investigator global assessment treatment success and eczema area severity index 75 scores Rux Cream versus vehicle. At EADV in October of this year, pooled analysis of the 2 phase 3 trials were presented. These pooled results reinforce the efficacy profile of ruxolitinib cream as it relates to IGS, EZ75 and the rapid, substantial and sustained introduction in patients with atopic dermatitis.
Newly presented data at EADV showed that patients on ruxolitinib cream also experienced significantly better sleep quality, sleep death, depth, and restoration. These results further highlight the potential for ruxolitinib cream to become an important treatment option for atopic dermatitis patients. We are on track to submit the NDA in atopic dermatitis at the end of this year and intend to use our priority review voucher which should accelerate the FDA decision. The priority review voucher is expected to shorten the FDA review period by 4 months Therefore, we could expect an FDA Our phase 3 program for Vitiligo is now fully recruited and we expect results in the first half of twenty twenty one. Given the accelerated timelines with the use of the priority review voucher, there is also the potential of an acceleration of the Vitiligo program, because an earlier decision on the atopic dermatitis NDA may allow for consequently earlier submission of the sNDA for Vitiligo.
Staying within our dermatology development group, we announced positive initial data for 54,707, an oral JAK1 inhibitor. In patients with moderate to severe high adrenitis suppurativa, which is a chronic skin condition, where inflammation and infection near sweat glands result in painful abscesses, sinus tracks and scarring on the skin. The phase 2 trial evaluated 3 doses of 54,707 versus Placebo, each of which were taken daily for 8 weeks, followed by 30 day safety follow-up. Preliminary efficacy was seen in a reduction in the number of abscess and inflammatory nodules termed the AN count. Which with results seen as early as week 1, as well as reductions in skin pain.
54,707 was well tolerated with no treatment discontinuations due to treatment emergent adverse events, and we have already initiated a larger 200 patient Phase 2b study. We are excited by the global opportunities for Tafasitamab and Slide 17 reminds you of our broad development program. Which covers several non Hodgkin's lymphomas in both the first line and the relapsed or refractory settings. We have multiple pivotal trials in preparation across indications, including 1st line diffuse large B cell lymphoma and in relapsed or refractory follicular lymphoma. We also expect to initiate our proof of concept trial, nivallumab, in combination with our PR3 kinase delta inhibitor, passed the Clicid, which the final protocol is in preparation.
Turning to our IO portfolio. At ESMO in September this year, we presented Phase II results from Podium-two zero two, evaluating redifandlimab in squamous cell anal carcinoma. The disease control rate of 49% and median duration of response of 9.5 months were well received we are opening a Phase III trial for rhodofanumab in patients with squamous cell anal carcinoma. Slide 8 also reminds you of the status of the other indications we are pursuing for ritafanlimab, as well as the important clinical translational data will be sharing from H650, our oral PD L1 inhibitor, which should to be presented at SITC next week. The translational data are from actual clinical specimens taken during the ongoing trial, and we will be able to share with you the data showing, for example, the degree of PD L1 inhibition and T cell changes illustrative of immune modulation with 86550.
We expect to provide a new Phase II trial in patients with treatment naive PD-one sensitive tumors as we continue to move forward with this important project. I will end my section on our development projects addressing COVID 19. With Lilly, we recently announced positive results for baricitinib in the ACTT2 trial in hospitalized COVID-nineteen patients. In combination with remdesivir, baricitinib reduced time to recovery improved clinical outcomes and showed a numerical decrease in mortality compared to remdesivir alone. These results were most pronounced in patients receiving oxygen.
Based on these data, Lilia submitted baricitinib to the FDA for potential emergency use authorization, and regulatory discussions remain ongoing. For Ruxolitinib, we recently completed enrollment of the Rux COVID trial, and we expect top line results from this trial by the end of this year. With that, I would like to turn the call over to Cristiano for the financial update.
Thank you, Steven, and good morning, everyone. The financial update this morning will include GAAP and non GAAP numbers. For a full reconciliation of GAAP to non GAAP, please refer to Slide 27 in the backup section of the deck and to the press release we issued this morning. Moving to our results for the third quarter. Revenue growth continued to be strong, with total product and royalty revenues of $621,000,000, representing an increase of 16% over the third quarter of 2019.
This reflects growth across both products commercialized by inside and those commercialized by our partners. Total product and royalty revenues for the quarter are comprised of net product revenues of $488,000,000 for Jakafi, $26,000,000 for Iclusit and $8,000,000 for Permater. Royalties from Novartis of $68,000,000 for Jakavi and $1,000,000 for Abrechta and royalties from Lilly of $29,000,000 for Olumiant. Total costs and expenses for the quarter of $559,000,000 on a non GAAP basis include the $120,000,000 related to the per of an FDA priority review voucher fully expensed under R and D, which we intend to use to accelerate the FDA review of ruxolitinib cream for the treatment of atopic dermatitis and $21,000,000 of upfront consideration and milestones related to our collaborative agreements. Excluding the impact of these expenses, our total cost and expenses increased 15% over the prior year quarter.
Ongoing R and D expense for the quarter was $268,000,000 on a non GAAP basis, representing a 7% increase from the prior year quarter. This increase was primarily due to our 55 percent share of the global and U. S. Specific development costs for Tafazitamab and the clinical trials of Ruxolitinib as a potential therapy for COVID-nineteen and was partially offset by the timing of other development activities. SG and A expense for the quarter was $106,000,000 on a non GAAP basis, representing an 18% increase over the prior year quarter.
This increase was primarily due to an increase in commercialization efforts related to Jakafi and Pemazir, the preparation for the potential commercialization of raxolitinib cream and the timing of certain expenses. Collaboration loss for the quarter was $50,000,000, which represents our 50% share of the U. S. Net commercialization loss for Monjubi. The total U.
S. Net commercialization loss of $30,000,000 for Monduvi is comprised of total net product revenues of $5,000,000 and total operating expenses, including COGS and SG and A expenses of $35,000,000. Our financial position continues to be strong as we ended the quarter with 1.7 $1,000,000,000 in cash and marketable securities. Moving on to our guidance for 2020, based on the continued strong performance of Jakafi in the 1st 9 months of the year, we are tightening our Jakafi full year guidance to a range of $1,91,000,000 to $1,940,000,000. This implies net Jakafi revenues of $489,000,000 to $519,000,000 for the fourth quarter of the year.
This range reflects some uncertainty associated with the resurgence in COVID 19. We are reiterating our guidance for both R and D and SG and A. As a reminder, the R and D guidance excludes the 805 $1,000,000 upfront consideration related to our collaboration with MorphoSys and the $120,000,000 of expense related to the purchase of the FDA priority review voucher. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q And A.
Certainly. We'll now be conducting a question and answer As a reminder, we ask you to ask one question and if you need one follow-up, then return to the queue. Our first question today is coming from Cory Kasimov from JPMorgan. Your line is now live.
Great. Good morning, guys. Thanks for taking the question. I guess I'll start with the obvious. Barry, can you just a little bit more about the real world physician feedback, the field teams getting on Monjovi since launch.
And is there anything that you're particularly surprised or pleased by relative to your prevailing expectations in these admittedly very early days. Thank you.
Sure, Cory. Thanks for the question. It's actually been very good. I participated in a number of advisory boards. Lots of our interactions now are virtual, of course, but, you know, I think most physicians, most hematologists would choose manjubi as being the preferred second line agent for most of their patients with diffuse large B cell lymphoma.
So we're very happy. We think our trends will continue to grow in the right direction. I think it's going as well as possibly go. And even, with COVID, for example, the the the, our sales representatives and medical representatives in the field, have actually been able to communicate and get into, their accounts, and talk about the benefits that Nonjabi provides.
All right. Great to hear. Thanks a lot
for taking the question.
Thank you. Our next question is coming from Brian Abrahams from RBC. Your line is now live.
Hi guys. Thanks so much for taking my question and congrats on the continued progress. I was wondering if you could maybe there's a question for both Cristiano and Barry.
I was wondering if you could speak to
the acquisition of the Priority Review voucher in atopic derm and I guess how you're thinking about potential return on investment in the context of what an initial launch trajectory could look like and the potential pricing strategy there? Thanks.
Hi, this is Cristiana. Thank you for the question. So on the priority review voucher, us Stephen described, we it provides us the potential to accelerate the overall timeline to market for RAC screen both for AD and Vitiligo. So for AD, it could shorten the FDA review period by 4 months from 10 months to 6 months. And then, if a d is if the d review is completed earlier than under the normal 10 month period, it gives us the possibility to subsequently submit the Vitiligo for a review earlier than we could otherwise do.
So given the potential opportunity we see with the RAC screen in both AD and Vitiligo, the met needs that we see in both indications, getting, RACS cream to market earlier than would otherwise, could, under the normal timelines, review timeline It's something that we see very attractive and was easily supporting the investment we made in the PRB.
And just to add, you know, I think we're completely ready to go as a new dermatology business unit. We're excited potential at rux Cream will offer to a whole range of patients with mild to moderate disease. And, you know, as far as, pricing and launch trajectory, trajectory thinks it's going to be very good. Pricing decisions haven't been made yet.
Great, thanks.
Thank you. Next question is coming from Salveen Richter from Goldman Sachs. Your line is now live.
Everyone. Thanks for taking the question. This is Andrea on for Salveen. Maybe another question on the new product launches Could you speak to what you're seeing with Temazir and any initial thoughts on what the drivers of momentum have been that have surpassed your expectations?
Sure, Andrea. Thanks, Barry. You know, the drivers of momentum are simply that this is the first targeted therapy available for patients with FGFR2 fusions or rearrangements. Really, these patients had nothing after second line therapy. So testing has been easier than we expected.
Next next gen sequencing, identifying at the right kinds of patients and getting the drug to them at the right time. Patients are, not only accessing the drug, but they're staying on drug, at least for the time being. Obviously, it's very early. But yes, we're quite pleased with the number of patients we have and the amount of patients that are coming back for refills.
Kevin, next question please.
Thank you. Our next question is coming from Evan Seagerman from Credit Suisse. Your line is now live.
Thank you so much for taking my question and really congrats on the continued progress. So, it's really clear that dermatology is the focus for you now. Can you provide some color as why you opt to invest and build your own dermatology franchise? I know there have been questions about whether or not you want to do an in house or partner out. And how large is this kind of commercial foursix exactly to be?
Then I have one follow-up there.
Maybe I'll take that over here.
Thanks, Irvin.
As you know, I mean, we have been sort of following the product. So the product led us into dermatology where if you remember, we had studies in alopecia areata That was the first study we did. And then we had the studies in atopic derm and BTIGO. I think what changed our view from, finding a partner and getting royalties for this is when we realize the profile of the product in atopic dermatitis is in fact very much superior to what you have available today. And the number of patients is potentially very large.
And then we also realized it was probably over the past 2 years that the benefit we are providing in Vitiligo is very unique. Vitiligo is not just a cosmetic issue. It's a life issue, and we can reverse for some patients, the disease that is hurting them. So when we came to the quantification of what it meant, we saw this opportunity in the U. S.
As being very meaningful for our goal of growth and diversification. So that's where we said we we could potentially do it ourselves. We have the team, we are putting in place. I think I described this in the past as two hundred people more or less something of that size. And it's in good it's in good shape to being built now over the next 6 months with priority voucher.
And, and I think it's a it's an opportunity for inside to have Italy a new franchise. It's not, changing our attention or taking our attention from cancer and immunology and hematology is literally a separate team. So there will be two legs now that will be basically driving the growth of insight starting in 2021. One of them will be the, we call it, the IAI immunology, dermatology, and the other one will be cancer And frankly, there is no real, change in our, you know, investment or energy that we put behind our cancer hematology portfolio is just an addition to what we had before. Now for the rest of the world, we are still in in a situation where we think we will have partnership for Asia and the last part of the work for the cream.
And in Europe, we are looking at what makes the most sense.
And one quick follow-up there. Beyond topical rux, do you expect, 5,400,707, to be the next key asset in the franchise?
Yes. Hi, it's Steven. So as you saw, it's another JAK inhibitor we have in our portfolio. It's relatively, JAK1 selective. We developing it currently in higher Granada Supertiva.
We believe based on research we've done that there remains an unmet need there because the available drugs aren't as effective as patients want them to be. And we're very encouraged by early data, which I showed you in terms of abscess reduction and skin pain relief. So, it's an important entity to study with a compound that is clean for that indication. Beyond that, what we do with the compound still needs to be determined.
There are additional indication for what cream we are also looking at. So the way we see it is that there is a developing portfolio that is evolving And at the same time, if you look at Exema and Vitiligo, we have 2 very large opportunities that are just in front of us, where we will have the first in class. We have the first JAK topic. And in the case of Vitiligo, it will be the first medicine to be approved for this patient. So there 2 very important short term growth driver.
And then there is obviously other products that will be or other indications that will be coming subsequently.
Excellent. Thank you so much for the color. Very helpful.
Thank you. Our next question is coming from Tazeen Ahmad from Bank of America. Your line is now live.
Hi, good morning. Thanks for taking my question. Just wanted to get some color on what that plays we could expect from the citadel program at ASH?
Hi, Tazeen. It's Steven. I think you're asking for a little bit of color granularity on the Citadel program at ASH. As you can see at a high level, the program continues to advance in terms of maturity of data. We have data being presented there in terms of an oral presentation in marginal zone lymphoma and then further presentations in terms of, mantle cell and follicular lymphoma, and the mantle actually is broken down into different presentations with prior BTK inhibitor and then the lack of prior BTK.
In totality, the data continues in our view to be extremely encouraging. The response rates have been maintained. Over time and they independently reviewed response rates and then keeping with what they should be in those different entities. And then very encouragingly the duration of response held up in the progression free survival as well. So we're encouraged by the totality of the data set And this is exactly what we wanted.
We wanted to have those response rates and now with further follow-up to be able to show that they're both durable and give you appreciable median progression free survival. So we're on track to in the U. S. To submit an NDA hopefully in the second half of twenty twenty one. And that's where we are with that important program for delta in lymphomas.
Beyond that, Delta has other indications we're pursuing. Obviously, in myelofibrosis in combination with ruxolitinib, start in our phase 3s there as part of the Lumber program. And then also just to mention in autoimmunity and inflammation, we also studying it in autoimmune hemolytic anemia. It's a very comprehensive program for a very active compound in our view.
Thank you. Our next question is coming from Michael Schmidt from Guggenheim.
Hey, guys. Good morning. Thanks for taking my questions. I had one on one Juvy with the application now being under review also by European regulators. I was just wondering, if you had any prior interactions with the EMA and what your confidence level is and potential accelerated approval in Europe.
There's been a few few rejections recently of oncology products based on single arm studies.
Yeah, Michael, it's Steven. Thank you for your question. You know, we correct and we've always prefaced, European regulatory discussions on single arm studies has been more difficult. As you just alluded, to some recent examples in areas where they've declined, approvals in certain entities. For Tafasitanumab itself, as ever even set up front, there and then Barry furthered by the real world experience, there's obviously a very strong data at a very high complete response rate that median duration of response for the CRs continues to improve.
In the update, the CRs was not even reached, but the median for the combined with PRs was 34 months. So we think that represents a very appreciable efficacy combined with a safety profile that's horrible. Obviously, our job is to convince European regulators of that given the single arm study and the real world evidence we have from Remind to say there's a discernible treatment effect that's appreciable and that we'd like you to approve it given that. And we're in that process now. And all I can tell you is it's going well.
I mean, it's marching through the different day, 120, etcetera questions that we need to have. And we'll see how it goes with them. It's hard to give you any further color other than that.
Perfect. Thank you. And then just on the first line, the planned first line DLBCL regulatory study. You know, looking at the abstract from first line, it looks like both of the combinations look, look very safe. Is there anything else that you're looking for in the first mind study before completing your plans for the, yeah, the phase 3?
Thank you for pointing that out. So you're right. The abstract is live now for the safety component of First Mine, which looks at TAVR plus R CHOP or Tafa Lane plus R CHOP. And you're right. Our interpretation is the same as yours that there's a comparable safety for both.
And we've already announced publicly that we're going ahead, thus, with the Tafelen archtop combination in the first line study. And then we're just working out the final details with regulators on size, and those sort of things, endpoints, etcetera. Will be ready to go soon. And obviously, a very important study, not only to us, but to the community in terms of first line diffuse B cell and lymphoma try and improve the cure rates from our chop.
Great. Thanks, Steven.
Our next question is coming from Jay Olson from Oppenheimer. Your line is now live.
Oh, hi. Thanks for taking the questions. I appreciate the, comments on the Pemozier launch. It seems like it's outperforming your ex locations. And I was wondering, I know you only promoted for cholangiocarcinoma, but are you seeing any spontaneous use in bladder cancer or other tumor types?
Thank you.
That's how I'm aware of, Jay. We really haven't dug into it all that much. It seems that, just about every patient that I'm aware of comes in is for, cholangiocarcinoma. Occasionally, we'll get a request for an individual patient for, individual IND for some tumor type or another, but, it's very rare.
Great. Thanks for taking the question.
Thank you. Our next question is coming from Marla Goldstein from Mizuho. Your line is now live.
Yes, just a follow-up on that question. So the announcement to discontinue the studies in bladder cancer, how does that affect the studies that you're looking at, for This is Andy.
It's Steven. Your question was breaking up a little bit, but I think you just wanted some view on our strategy in bladder cancer with our FGFR inhibitor. I think if you step back and you look at how, lattacancer, particularly metastatic bladder cancer is evolving with new datasets with checkpoint inhibitors, with EV from Seattle Genetics. Clearly, there's a change now in the treatment paradigms and treatment porcine therapy in bladder cancer. And what we want to do is literally do that.
We feel that our in conjunction with our advisors that our current 1st line study does becomes irrelevant given how care standards are changing. And we and obviously have stopped recruitment there. And we're relooking at the bladder program in totality, looking at the biology, particularly just to give you some granular detail, given EV's effect in Nectin expressing bladder cancer, we want to ascertain whether FGFR3 on its own is a separate driver in the setting And if it is, how that will play with our FGFR inhibitors. And we're busy doing that preclinical work to understand the biology right now. This doesn't change our strategy for pemigatinib in the agnostic program, which is recruiting very well.
Nor in the myeloproliferative neoplasm AP11. But we feel bladder is evolving enough that we need to step back and understand the biology there.
Okay. Thank you. I appreciate it.
Thank you. This is coming from George Farmer from BMO Capital Markets. Your line is now live.
Hi, good morning. Thanks for taking my questions. Nice to see the rebound in new patient starts with Jakafi after the after the slowdown due to COVID. Where do you see that going going forward? And could you comment on your progress with Jakafi in chronic GvHD?
Sure, George. I'll take that. So, new patient starts have actually, especially within the last 2 weeks, even, come back to almost pre COVID levels. So we're happy with that. If, you recall in the first quarter, in fact, our new patient starts were, we were extremely pleased with.
And, until COVID hit, you know, we look like we're going to have a very, very good year. So we're hoping to get back, to that, that number of new patients on each of the indications. Of course, we're looking forward to the approval in steroid refractory chronic GvHD sometime next year. And, we really think that This is going to be a great benefit for patients. We know that there's, you know, the prevalent population in chronic GvHD is fairly high compared to the acute steroid refractory GvHD patients.
So we really believe that there's an opportunity for more growth there with the patients longer duration of therapy, when you're treated for chronic GVH D. So we're looking for that approval. Thanks,
Barry. It's Steven. Just to add a little bit, you saw the abstracts go live yesterday and the reach and oral presentation at ASH. And again, now a second study, large study, randomized study in GvHD that's positive. So it's a good achievement, obviously, for drugs the drug and really important for patients.
If you look at the totality of the data in the abstract, it's superior efficacy versus best available therapy with higher response rate, longer failure free survival and better symptom improvement. What's not in the abstract, but will be presented at the actual median is also best overall response at any time, just to try give you comparative data to other agents. So it's an important oral presentation at ASH. And as Barry said, our intent is to get the submission in as soon as possible given that.
Great. Thanks very much.
Our next question is coming from Kenneth Atkins from Cowen. Your line is now live.
Hi, thanks for taking my question. For your JAK1 inhibitors, 707, what do you think you need to show in hidradenonitis in the the phase 2b to to
have a compelling profile there, versus standard of care?
Kenneth, hi, it's Steven again. Thank you. So it's a disease as we were outlining in our formal presentation, that has a lot of more for patients given this abscess formation in different skin folds in the body. Obviously, TNF inhibitors are licensed and used there with not the efficacy that I think patients fully want. So the idea was here to try given the biology relative JAK1 agent to try and get further improvements in abscess, formation sinus tract, etcetera.
We use so you got to be really careful on what you do cross trial comparisons here. So for this data set, we use what's called an AN count. And we believe that's the best way to measure patient benefit here. But there are other endpoints that are used in other studies particularly for TNF, there's HI SCR that's used, which is a greater than 50% reduction in AN count, but no increase in new lesions. So it's a combination thereof in terms of the lesion improvement plus ways of measuring clinical benefit and mobility on patients.
And that's why it's very stepwise development. We're now going to Phase 2b with a 200 patient study and we're likely to then need a phase 3 program to get it across the finish line. But we're told repeatedly by people in the area that there remains this unmet need here And that's what we're going to try and address in the phase 2b that we have enough efficacy to get there in terms of AN count reduction.
That's helpful. Thanks. Thank
you. Our next question is coming from Andrew Berens from SVB Leerink. Your line is now live.
Thank you very much. This is Gan Lee for Andy. Just a quick question regarding the atomic, Jack Fi, the topic of Jack Fi. So how do you see the opportunity in more severe atomic dermatitis patient once it's approved. Do you see that more in combination with other systematic treatment or, it's, it's a monotherapy?
Thank you.
So, thanks, Gang Lee. So I I think there an absolute op well, if you look at our studies, true AD1 and true AD2, you see there's a high proportion of patients with moderate disease. So we think when we look across trials, we could have an opportunity there, but we really think it's going to be the best, drug available for patients from the from steroids all the way up to biologics. So we think we have a clear opportunity there. If it's going to be used in the future, with with biologic like Dupixent, for example, you know, we'll have to wait and see.
Obviously, Dupixent and is often used with topical steroids now because you have to have some local control for for particular parts of, the skin or disease. It could happen in the future, but that's certainly not our indication. We didn't study patients with severe disease, but, we do believe that there's a wide range of patients who will absolutely benefit from Rux Cream. Thank you. Our next question is coming from Stephen Willey from Stifel.
Your line is now live.
Yeah, good morning. Thanks for taking the question. Maybe one for Stephen, I guess, how should we just be thinking about the go forward dosing strategy for Parsiclusive and some of these desal malignancy subtypes I know the ASH abstracts kind of highlight a little bit of a response rate delta between the weekly and in daily dosing, which I think also appears to be a little bit tumor type and maybe line of therapy dependent. So should we expect that you're going to be pursuing kind of a different dosing strategy in some of these different subtypes? Or would you expect to have one that kind of covers the whole gamut of B cell malignancies?
It's a good question and thank you for it because we did spend a little bit of time trying to work out the optimal dose and schedule, to get the therapeutic ratio we wanted in terms of the efficacy and safety benefits that we wanted to weave. For the class, it's had a bit of a rocky run over the years, starting off with Adelyssa early on. And particularly people were concerned about longer term toxicity and things like colitis. We knew from the get go, the drug is incredibly active. So we wanted to work that out and we spent some time doing it.
So where we are now is where we think is the optimal way of doing it. And you'll see in the abstract the totality of the information. But we start off at a high dose, 20 milligrams daily for the 1st 8 weeks. And the idea there is to maximize efficacy these patients when they respond, they respond early and quickly. So the vast majority, if not all of the responses happen in that time period, And then we step back and we looked at after that weekly maintenance versus daily.
And again, look at both retention of efficacy then as well as safety And it turns out that that's best for us is afterwards to switch to the daily dosing and not the weekly maintenance. So if you look at the totality of the data there, you retain see, we're getting the durability of response in PFS. We want, but we've also been able to tone down some of the toxicity with that regimen. So I think going forward from a regular of view. Obviously, you're going to have to work with regulators around the world.
Yeah. You'll be looking at 20 milligrams induction for 8 weeks followed by the daily schedule thereafter.
Great. Thanks for taking the question.
Thank you. Our next question today is coming from the line of Matthew Pipps. Your line is now live.
Good morning. This is Rob Andrew on for Matt Phipps here. So maybe just on the early stage programs with the BetNAL 2 inhibitors, just getting started up here. Maybe what are the expectations, with those programs given the monotherapy dose Are we clearly looking for a safety profile, acceptable for Jakafi Combinations or what are the expectations there? Thank you.
Steven, thank you for your questions. So I'll separate them out because Bet has a slightly different history. So if you look at BET BRD, this is a compound we had in the clinic a few years ago, primarily targeting solid tumors and working on a slightly different hypothesis around MYC inhibition. And we were at multiple that the dose we were at now we were at 12 to 16 milligrams, whereas we had 4 milligrams now. And what we saw there in that program a couple of years ago was on target toxicity in terms of thrombocytopenia as well as other some worrying toxicity.
So we had put ourselves on a clinical hold at the time for that compound. And then what happened over the ensuing year with Bet, as you saw data from Constellation and CPI come forward. And we knew, by the way, the biology was relevant in myelofibrosis. And we think there is something to that data set and there is clearly an effect from addition of bet therapy to ruxolitinib. So we revitalized our own program there.
We worked with the FDA to come to what we think is a safe starting dose to avert a lot of the toxicities modeled off what we saw happening in an external world. And we've restarted the program. What we have to do is demonstrate monotherapy safety, which we're doing now with the bet, and we expect that to be the case given the dose we're using. And then quickly go to combination with ruxolitinib. So that's the story behind that.
In terms of L2, this is a very exciting program to us. We think the anemia seen in myeloproliferative neoplasms, particularly in myelofibrosis is mediated through the hepcidin pathway. Building a little bit on the moment. Let me update it there as well as the anemia seen with the use of JAK inhibitors. So we're trying to ameliorate that anemia of the underlying disease plus potentially the JAK induced anemia so that you can maintain dosing and in fact as a query of that actually increase efficacy as well, because you can stay on the combination.
So again, the idea is to get to, to help to monotherapy safety pretty quickly. And then start the combination very soon with both. Elk 2 in terms of its mechanism of action may have utility in anemia is across the board, in terms of hepcidin inhibition. So that's something we're interested in. And then there are some entities where solid tumors may have underlying genetic mutations that may be amenable to this as well.
So it's it's a very interesting program, a very interesting mechanism, and we go in fast.
Great. Thank you.
Yes. Just to add
one more thing, because I didn't just we also study in a rare disease, which is also mediated by the program FOP, which is a condition where you get premature, bone formation in soft tissues, a lot of morbidity from it and sometimes early death as well. It's a rare entity, but again, it's something we committed to doing, as well. So we will have an FOP program as well with the L2 agent.
Thank you. Our next question today is coming from Adrienne Housumov from The Benchmark Company. Your line is now live.
Thank you for taking my question. I have one about Dermatology. So given relatively high vehicle responses, 10 to 20%. So what would be your sales speech to a dermatologist, especially when we hypothetically compare our screen to other standards of care, not necessarily vehicle. Thank you.
Well, Aidan, this is Barry. First of all, I think that our response from the TRUAD1 studies and TRUAD2 studies are very good. And the difference the delta between the active drug and the vehicle is very good. And as compared to other therapies, Well, oral therapies for that may be coming oral JAK inhibitors that may be coming for atopic dermatitis. Obviously, you're pressing the entire immune system when you take an oral drug.
So that doesn't seem to be the best way to go about it. We have a a great check inhibitor that's topical that you can apply right on the area that's most effective. So we think that's an advantage for us. And as far as just some of the evolving data, that might be coming from other, topical JAK inhibitors, we've seen the data so far. We don't see any reason to be concerned about it, and there's still some questions about their, dose response of those therapies.
So our sales pitch is actually we've, you know, had many interactions with dermatology, a very positive interaction with dermatologists, and they feel very strongly that this is a drug that they've been looking for a Rux Cream. So, I think it'll be a relatively straightforward approach. We'll talk about the science. We'll talk about the benefit that it offers to patients who are really suffering from this autoimmune disease atopic dermatitis.
Thank you.
Thank you. Our next question today is coming from Vikram Purohid from Morgan Stanley. Your line is now live.
Good morning. Thanks for taking my question. So I had a follow-up question on real world use for Monduvi. So to the best of your knowledge, has there been much or any off label use of Monduvi in combination with another agent like Bendamustine, or has it so far primarily been in line with the labeled use in combination with lenalidomide?
Yes, Vikram, you know, I don't well, depends on what you call off label. Certainly, we've been used, in a whole variety of places, relapse refractory, for a second line and plus, you know, obviously, we're studying the drug in combination with bendamustine in the future. So we'll have multiple other studies that will have a chance to see what different combinations, including Parsoglyceph that we'll try to study the drug with in the future. So, we're excited about that, but I think that most, hematologists oncologists are most excited about what Steven was talking about before about our complete response rate and how high that is in a in a long duration of response that continues to get better. So the combination of Len plus Manjubi right now has both the efficacy and safety profile that most physicians who treat diffuse large B cell lymphoma are looking for.
Okay, understood. And as a follow-up Had a question on the ASH abstract on the first mine safety data. So I believe that abstract mentions that we could see some initial efficacy data during presentation at ASH. To the extent you can discuss it, could you characterize a little bit about what we could see there and what we should make of it and how we should interpret it when thinking about ManjuV in the first line setting?
The entire intent of the abstract and presentation is safety and that's what I'll point to. And just to be maybe a little bit repetitive on my earlier comments, Given that the safety of the combination of TAPA Lane R CHOP is very similar to TAP R CHOP given that you have to, you know, aiming for cure here and maximizing cure rates, you know, it became automatic then that Tafelinaar Chop was the way to go. In terms of the first line study. I think given the intent of safety, that's where you should focus on what the presentation will be about. And then obviously, we'll have to wait for a large first line study to deliver here.
Thank you. Our final question today is coming from Alethia Young from Cantor.
Hi, good morning. This is Lee on for Alicia. Thanks for taking our call. Maybe just one, on your PD-one program, how does your, Phase 2 data that you presented as small match up with, standard care? And can you just remind us of your strategy in the PD-one space since it's, crowded?
Are you looking at, you know, indications that sort of last developed? Are you looking at combinations or both? Thanks.
Yes, thank you. So again, to step back, we acquired this compound to use on its own and then in various combinations, which we needed for within our own program, and that's what we've been doing. At the same time, the intent was of to get it registered and we had, upfront the niche tumor approach in squamous cell anal carcinoma, Merkel cell carcinoma and MSL high endometrial, and those studies have all enrolled well. And this is the data you see come to fruition. In terms of squamous cell, anal carcinoma, the benchmark is the keynote 1 58 study, from Pembro, but the mature data set where, the Pembro overall response rate was 11%.
You can see our response rate little bit north of that territory in the 13%, 14% range that's independently reviewed. In addition, there's a subgroup of patients to HIV positive with this that are, have that unmet need and were addressed in our study, which hasn't been addressed in other studies. So we're very encouraged obviously by that data set and thus initiated a phase 3 and it's right in the territory of what seen just to be repetitive with other PD-one inhibitors in this entity, plus other entities that are very similar like cervical cosinoma. Beyond the niche tumors, we have an ongoing lung program that's now initiated globally, a lung study then as I said, we continue to utilize rhodofanlumab with various internal combinations.
Great. Thank you very much.
Thank you. We've reached end of our question and answer session. I'd like to turn the floor back over to Mike for any further or closing comments.
So thank you all for participating in the call today and for your questions. Of course, Christine and I will be available for the rest of the day, and we look forward to engaging with many of you in the coming weeks at investor and also at medical conferences. For now, though, thank you again. And goodbye.
Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.