Q2 2023 Rigel Pharmaceuticals Inc Earnings Call
Okay.
Greetings and welcome to the Rigel Pharmaceuticals Financial conference call for the second quarter of 2023 at this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded it is now my pleasure to introduce our first speaker Rafe theory, Rigel Executive Vice President General Counsel and corporate Secretary. Thank you. Mr. Ferry you may begin.
Welcome to our second quarter, 2020 trade, but actual results and business update conference call.
Actual press release for the second quarter 2020 trade was issued a short while ago and can be viewed along with the slides for this presentation and the news and events section of our Investor Relations site right.
As a reminder, during today's call.
May make forward looking statements regarding our financial outlook, our plans and timing for regulatory and product development.
He said these statements are subject to risks and uncertainties that may cause actual results to differ those forecasts.
Description of these risks.
Can be found in our most recent annual report on Form 10-K for the year ended December 31, 2022, and the subsequent filings with the SEC.
Our second quarter quarterly report on Form 10-Q as filed with the SEC.
Any forward looking statements are made only as of today's date and we undertake no obligation to update these forward looking statements to reflect subsequent events or circumstances.
At this time I would like to turn the call over to Robert.
Our president and Chief Executive Robert Rodriguez Route. Thank you Rachel and thank you everyone for joining today.
With me today are David Santos, our Chief commercial officer, and Dean shortening our Chief Financial Officer.
Beginning on slide four we are pleased with the progress we've made in the first half of 2023 as we continued to build our hematology oncology company with our commercially available products and our development programs.
In the second quarter, we continued to see year over year growth in demand for our first approved product top of at least four adult chronic RTP.
We're also pleased with the progress that we've made on the launch of our second approved product rich linear for adult relapse or refractory <unk> positive AML.
As we navigate the launch a core focus of our commercial and medical affairs team has been driving awareness for bridge linear and establishing relationships with new doctors.
A few key highlights on these initiatives from the quarter include robust engagement with the medical community at the 2023 <unk> annual meeting.
The presentation of promising data in a post spin out of <unk> treated patients at the European Hematology Association 2023, Congress and a second publication or blood advances examining the preclinical and clinical development of <unk> video and its role in the treatment landscape.
These are important data that we recently published and presented Dave will touch on these items a little bit later in this presentation.
Looking at our development and expansion initiatives, we've made progress in the enrollment of our phase one B study bar to ignite our Iraq, one and four inhibitor in lower risk Mds and we are evaluating opportunities to expand our hematology oncology business further.
With clinical development for our already approved products into new indications.
Additionally, our rib K one program has advanced with our partner Eli Lilly and continues to progress with the initiation of a phase Iia trial in patients with rheumatoid arthritis in the second quarter of 2023.
I will provide further updates on our progress and strategies for these efforts later on in today's presentations.
With that I'll turn the call over to Dave for an overview of the quarter to date.
Thank you Raul.
Now I'd like to take a few minutes to discuss our continued growth in top lease during another record quarter and our progress with Reds litany brands linear launch in the first half of 2023.
On slide six you'll see our FDA approved indication for top leaf, which is for adult patients with chronic immune thrombocytopenia or C. I T. P. You've had an insufficient response to a previous treatment.
Moving to slide seven I'm pleased that we achieved another new quarterly all time high with top police in Q T. Shipping 2200, 65 bottles to patients and clinics, representing 10% growth over Q2, 2022.
We have now achieved three consecutive record highs for the number of bottles shipped to patients and clinics in a quarter since launch.
We continue to grow our demand through consistent flow of new patient starting top lease and for Q2, we achieved net sales of $21.3 million to $8 million more than the same quarter last year, representing a 15% year over year increase.
We are pleased with how we have grown our <unk> business. During the first half of 2023 and look forward to carrying this momentum into the second half of the year.
We'll continue to focus on targeting clinicians to identify appropriate patients who can benefit from top place to grow our new patient starts beyond the record levels. We saw in 2022.
I'm grateful to the entire team for continuing our growth with probably some I T P. While we launch rest linear.
Moving to slide eight I wanted to review the opportunity we have with total lease and chronic ITT and provide an update on our progress in moving to earlier lines of therapy.
First on the left recall that we estimate there are more than 80000 patients with ITT and more than half of them are actively treated.
While most of the patients are on steroids as their first line therapy.
Still more than 24000 patients who are eligible to be treated after steroids and three quarters of those patients are in the second or third line.
On the right you will see how the portion of second and third line new patients on top of lease has grown since 2021.
For three consecutive quarters more than 70% of the new top lease patients that we captured through our hub have been.
In either second or third line.
We are very pleased to see this consistency of earlier usage in patients on top of lease over the past three quarters.
As more patients are being treated with <unk> earlier in their course of treatment. We expect our refills bottles to continue to grow due to the improved persistency, we should see from those patients.
On slide nine we believe the reason we have been successful in getting more of our top of lease patients earlier in the treatment continuum is that our efficacy message is hitting home.
Clinicians are impressed with the earlier they use Tom Elyse the better their results and when they do use top of lease they can count on clinically meaningful and durable increases in platelet counts over time.
These messages are resonating and our business is continuing to grow well.
We will continue to promote the benefits of using <unk> earlier after steroids.
And how the durable predictable platelet increases are meaningful to patients who live with chronic I T P. Each day.
On Slide 10, a reminder, that in April our partner key say announced the launch of <unk> for the treatment of chronic ITT in Japan.
We remain committed to continuing to impact C. I T P patients around the globe with the expansion of <unk> commercial footprint through our partners.
Moving to slide 11, I'll take a few minutes to discuss our continued progress launching Reds linear in the first half of 2023.
On slide 12, you'll see our FDA approved indication for Wrestlemania, which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible I D. H one mutation is detected by an FDA approved test.
As an introduction on slide 13, there continues to be an unmet need for efficacious targeted treatments in relapsed or refractory AML and in particular agents that provide longer durations of response, and an acceptable balance of efficacy and toxicity or need it.
We continue to strongly believe that resolutely addresses exactly those needs.
Moving to slide 14, and our view of the currently eligible patient population for rents Lydia.
The American cancer Society estimates that more than 20000 patients will be diagnosed with AML in 2023 and of those patients. Our research shows that whether patients are treated with intensive therapy or not most are refractory to treatment or relapse within two years.
Specifically with 6% to 9% of patients having b I D. H one mutation. We believe we have a near term opportunity to impact the lives from around 1000, New Butte 90, H one patients in the relapsed or refractory setting each year.
Slide 15 shows our continued early launch progress in bringing rents linear to those 1090, H, one relapsed or refractory AML patients.
We sold a total of 200 bottles of rents Lady in the second quarter, representing 77% growth over Q.
187 of those bottles were shipped directly to patients and clinics and our demand grew second quarter net product sales to $2 $6 million with our total launch today sales now at $4 $9 million.
We continue to remain focused on growing awareness of rents Lydia through our field teams and other activities.
Moving to slide 16, we made solid progress in Q2 on growing that awareness through both promotional activities and scientific applications first on the left we have a strong presence at the Ash annual meeting in early June It was the first major conference opera.
And even for Rigel to promote a top of lease and British Columbia.
And we officially launched our rents linear transform your expectations durable remission is possible campaign there.
To go along with that we have updated both our HCP and patient websites with our campaign and visitors to raise linear dotcom have a wealth of information and resources at their fingertips.
On the right side of this slide you will see the significant progress we have made on the scientific front in Q2.
First in May there was an excellent alluded to Nip review article published in blood advances discussing the positioning of rest Lady yet in the mutant 90, H, one AML treatment landscape.
And the conclusion the authors quote.
Recommend aledo, Sydney in Banana Clacks, plus HMA failures, given the available data unquote.
The data they were referring to was also presented this quarter at the European Hematology Association 2023 hybrid Congress held in Frankfurt during June .
That post their focus is on these very clinically relevant population of patients who were previously treated with a spin out of class.
The conclusions were very consistent with our previously reported results. The authors shrimp that Olivia Sydney induce durable remission and that the observed activity is clinically meaningful and represent a therapeutic advance in the treatment of this molecularly defined poor prognosis.
Patient population with relapsed or refractory mute 90, H one a M L.
Our commercial and medical Affairs team members have had several recent discussions with key academic leukemia specialists since that data was presented in June and they have expressed the same sentiment since the authors they.
They view the data as promising.
And interest in our latest Sydney continues to grow.
Overall, we made significant progress during Q2 and importantly, some key drivers to the elite is Sydney story, such as the compelling activity in post spin out of class patients just began at the end of the quarter.
In addition to that as key drivers in late Q2 on slide 17, we have other activities planned for the second half of this year that we expect will enable us to continue building momentum with breast Libya first on the list. We now have the institutional team we announced last.
Warner in place.
Recall that a significant portion of our AML business is concentrated in academic institutions and the leukemia treaters in the skin genius centers influence how the community treats AML.
We hired eight institutional business managers across the country. So it will be accountable for leading rents linear promotional activities with these top leukemia, treaters and facilitating formulary placement at key leukemia centers.
They have impressive experience on average the member of members of this team have more than 19 years of he mark experience with 14 of back calling on hospitals.
They are also experienced in other key commercial functions, including sales management market access marketing Kols development and key account management.
I want to warmly welcome them to the Reds liddy of tea.
I'm looking forward to reporting on their accomplishments as we move forward.
In addition to the institutional team, we continue to schedule incomplete more peer to peer speaker programs improve our presence in key leukemia in hematology conferences that we will be utilizing timely non personal promotion through innovative channels during the second half of the year and.
And of course, we will continue to maximize access for patients through our hub and other patient and H C. P resources.
On the scientific side, we are planning additional publications from the phase II trial, highlighting more key mute 90, H, one relapsed refractory patients along with the post spin that a class population as well as providing more elitist Sydney evidence from populations outside of <unk>.
Pivotal cohort.
In addition, we'll be working to generate supportive data in difficult to treat mute 90, H, one relapsed and refractory patients to bolster our current story.
And finally, our medical affairs team will continue to provide relevant information and education for Hcp's involved in AML treatment and gather insights from our kols to determine our understand to deepen our understanding of where else we may need to develop I'll leave you sitting there.
Yeah.
Overall, we're looking forward to building additional momentum with all of these initiatives as we move through the second half of 2023.
And finally on slide eight T. After our experience during the first six months of launch we believe now more than ever that linear has the potential to address many key patient and HCP needs in relapsed refractory AML.
It's a promising treatment targeting mute 90, H one that has shown impressive durable responses in patients who failed previous therapies. Overall, we continue to see exciting potential to become a market leading treatment in Butte 90, H, one relapsed refractory AML and are looking forward to continuing to execute our launch.
Yeah.
My thanks to the entire team for all their efforts during the first half of 2023 with Red So linear and I look forward to providing you with additional launch updates in the future. Thanks for your attention and I'll now turn the call back over to Ralph to provide a brief update on our development progress Raul.
I will now summarize our development programs going on.
On to slide 20, thank you.
We outline our ongoing development programs, we are focusing on growing our hemo business with our internal development plans. We believe both the post imatinib and all of a sudden it has potentially other diseases beyond the already approved indications and we're currently evaluating several options. In addition, we are a value potential and license out.
Similar to the approach we took with rigs lithium.
Our ongoing phase one B study a bar to acknowledging Iraq, one four inhibitor in patients with lower risk Mds continues to progress well, we have completed enrollment in the targeted number of patients in the second cohort of the trial and expect to begin enrollment in the third cohort in the near future I will touch more on this program in a minute.
More opportunistically.
Eli Lilly is advancing our pipeline to R. K, one inhibitor with the initiation of their phase II study in rheumatoid arthritis. As a reminder, this study will enroll approximately 100 patients with moderate to severely active rheumatoid arthritis and the analysis is expected at the end of 2024.
Moving on to slide 21.
I wanted to spend a few moments discussing the treatment landscape for lower risk Mds and how we think about our Iraq. One four inhibitor are two 8 billion.
And how it could address an unmet need for background MTS is a disorder of hematopoietic stem cells resulted in dysplasia and ineffective who came out of polices in the bone marrow.
For patients with lower risk Mds risks include autoimmune abnormalities side opinions progression to AML and thus.
Patients undergo treatment their blood transfusions are written polices stimulating agents or Esa is for anemia in the first line setting.
I don't mind news Patterson Hma's immunosuppressive therapies in the second line setting a durable responses in this setting are not common subsets of patients showed limited him out of plastics.
Logic responses and these agents resulted in significant adverse effects.
Loss of response following second line therapy represents a poor prognosis for patients associated with significant morbidity inside opinions.
So there remains a significant unmet need for lower risk Mds patients, who are refractory or resistant to current therapies and we believe archway.
Has the potential to address this need and this underserved patient population.
On slide 22, you'll see our ongoing open label Phase <unk> study of bar to ignore it as mentioned we have completed enrolling the targeted number of patients in the second cohort of the trial and expect to begin enrollment of the third cohort in the near future.
Moving on to slide 23.
We continue to evaluate post Amanda and overshooting them and additional indications beyond their approved indications working with Kols regulators. We are evaluating these programs across multiple indications lines of therapy and treatment regimens as well as conducting market research to help inform our plans moving forward.
We look forward to providing additional updates on this initiative. These initiatives later on in 2023.
Regarding our business development efforts related to the in licensing of new assets. We are continually evaluating assets that are synergistic with our existing chemo infrastructure and there are complementary or adjacent to our already approved products. We are focused on programs that are in late stage clinical development and review for potential approval or in.
The early stages of commercial launch.
Without development capabilities and commercial infrastructure, we have the potential to grow our business from internal programs as well as being the potential commercial partner for in licensed or acquired hemo products.
With that let me turn the call over to Dean for a financial update.
And thank you all I'm on slide 25 for the second quarter of 2023, we shipped 2191 bottles are probably to our specialty distributors, resulting in $32 million of gross product sales 2265 bottles on top of ways were shipped to patients at clinics or 74 bottle.
<unk> decreased to levels remaining in our distribution channels at the end of the quarter.
For the second quarter of 2023, we shipped 200 bottles of <unk> to our specialty distributors, resulting in $3 $2 million of gross product sales.
187 bottles of first media were shipped to patients and clinics, while 13 borrowers increased levels remaining in our distribution channels at the end of it.
Quarter.
We reported net product sales from <unk> of $21 $3 million in the second quarter of 2023, a 15% increase compared to the same period in 2022.
<unk> net product sales from <unk> of $2 $6 million in the second quarter of 2023.
Our net product sales from top resources media were recorded net of estimated discounts charge backs rebates returns co pay assistance and other allowances of $9 $6 million for the second quarter of 2023, our gross to net adjustments Tabori Emirates Lithia was approximately 29 five.
At 27%, our gross product sales respectively.
Before I move on from net product sales a member of your expectations for the third quarter of 2020.
We're pleased with the strength of our business in the second quarter and expect to see continued strength in our year over year total net product sales growth rate as bottles shipped to patients and clinics continues to grow across our business incrementally. We expect gross to net adjustment in the third quarter of 2023 to be approximately 30.
One per cent for Tom Louise and approximately 21% to 22% for somebody else.
Onto the next slide in addition to net product sales for the three months ended June 32023.
Rogers contract revenues from collaborations were approximately $2 million of which $1 $2 million was from the delivery of drug supplies and $800000, whereas from royalties from our collaboration agreement with referrals. We also recognized $1 million in government contract revenue.
Related to income recognized pursuant to the agreement with the U S Department of defense to support our phase III clinical trial of fast Imatinib and high risk hospitalized patients COVID-19.
Moving on to costs and expenses our cost of product sales was approximately $1.1 million for the second quarter of 2023.
Costs and expenses were $32 $2 million in the second quarter of 2023 versus $42 $8 million in the second quarter of 2022.
Increase in cost and expenses was primarily due to trial completion activities.
The phase III clinical trials for warm autoimmune hemolytic anemia, and the phase III clinical trial in high risk hospitalized patients with COVID-19.
Well its timing of activities related to our Iraq, where import inhibitor program.
Well, we did see a significant drop in operating expense during the quarter were expected operating expenses in the back half of the year to return to at least first quarter of 2023 level and we expect to both further our current clinical efforts and expect to ready for the initiation of new clinical studies as Ralph described.
We look forward to provide an update on these potential studies in upcoming quarters and will continue to provide operating expense are paid for it in a way.
We ended the quarter with cash cash equivalents and short term investments of $64 $4 million with that I'd like to turn the call back over to al.
Thank you Dean as.
As we reviewed on this call we had a productive first half of the year and we are focused on our 2020 free catalyst in Q2, we just exceeded our quarterly high for demand bottles for total knees and we look forward to continue to drive momentum for top of lease sales in RGB, both in the U S and globally with our partners.
We are executing on the launch number is linear in relapsed refractory AML and now with our academic institution focused sales team fully on board and several recent resin linear publications and presentations, we are well positioned to grow awareness for this product as a new treatment option in.
In addition, we are Indemnifying ex U S collaborators for this product.
We will evaluate new potential opportunities for both foster massive and all the signals.
To advance our two week now in phase, one B study and actively pursue business development and product opportunities.
So with that let me and say I want to thank you for your interest in the second quarter and we will now open up the call to your questions.
Operator.
We will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star Q1 moment. Please while we poll for questions.
Thank you.
Our first question is from Yigal <unk> with Citi. Please proceed with your question.
Yeah, Hi, IRA and team. Thank you.
I'm, just trying to get a better understanding of how you're managing the business with respect to the path to profitability I think this quarter.
The the closest to breakeven excluding.
Excluding some of the one timers, where you had net profit given collaboration on a milestone you mentioned that you're gonna be potentially investing in new opportunities for post imatinib.
As well as in licensing.
But the top line, obviously is growing too.
And then just and you mentioned that the expense line might increase a little bit back to the one to 23 levels. So could you just talk about all of that together and how are you thinking about managing the business to get to break even.
Beyond that over the next coming years.
Thank you Hugo.
Sure well, let me turn to Dave to give you an overview on how we're looking at this pad towards breakeven and in our investments further.
Hi, Yigal. Thanks for the question. So let me start with just the change in cash for the quarter, which you, which you highlighted a little bit in your question. So so with the.
Cash increased by $5 $6 million for the quarter be the basis of that increase in cash was really the strength of sales.
Which which is offset by the operating expense I bet operating expenses you highlight is a is a fairly low.
The low level of clinical spend and that's that's simply a result of its just timing of our activities. We we as you look back a year, we wrapped up the warm autoimmune hemolytic anemia.
As well as the Covid phase III efforts as well as there is some variability in our Iraq, the timing of alright, Iraq spend so that's that really resulted in about 130.
$32 million out of operating expense for the quarter.
The net loss for the quarter $6 $6 million, a $2 5 million of which was non cash.
<unk> also contributed to strength in cash and then finally, we had a about a half million dollars pick up in accounts receivable. So we had a a slightly high accounts receivable balance in Q1 and that normalized in Q Q2, So all said worried about $5 six.
In dollars of increase as you highlight in your question getting to profitability in the path to profitability is important to us.
And this quarter highlights the potential for for that path to profitability.
We do expect in the back half as I said in my prepared comments to get back to to Q1 like operating expense levels, but we do expect the revenues to continue to grow we expect to continue to manage operating expenses very effectively as we have and that will ultimately.
We believe lead us to to profitability all of that said, we haven't given top line guidance and therefore can't be specific on when will when will crossover, but again I'll reiterate that bad.
It certainly is a focus of the business to get to that profitability.
Thanks, Dan the only the only thing I'd like to add further is that it's an important priority for us but it also means that are important to fund the new opportunities that are both our internal as well as all the things we might even license because that continues to be a priority for both of those things we like the business, we like the growth of the business, we wanted to grow and be even gray.
And bigger in the future.
Okay. Thank you very much.
Thank you Don.
Thank you. Our next question is from Christian cluster with Cantor Fitzgerald. Please proceed with your question.
Hi, everyone. Thanks for taking my questions I found it really helpful to understand a little bit more about what you're seeing in terms of new patients. So thanks for sharing that with us. So I wanted to see if you could talk about what the compliance is you're seeing amongst your different lines of treatment and also.
The responses are pretty much in line with your own analysis since you've been tracking this for a couple of quarters now.
Yeah. Thank you for asking that question, we're excited to share some of that information Dave.
In fact, Chris and in depth.
I I will say that it's we don't have an ability to kind of take them be the patients that are on therapy in the second and third and determine response rates. If that was your question, but I will comment on kind of what we've looked at in terms of.
Persistency and it is still early but what we looked at is the patients who started in Q4 of last year. When we saw this higher percentage of third and fourth line patients and we compared it to patients who started in Q4 of 'twenty, one and Q4 of <unk>.
<unk> 20 <unk>.
And if you look at their persistency Ah at four months and beyond.
First is the persistency of patients who were in 'twenty, one or 'twenty. It is trending higher and so we do think this is a positive trend.
Again this is only been happening for three quarters. So it's going to take some time for this to reflect in a larger number of rebuilds, but certainly we believe our business is going in the right direction.
Okay. Thank you for that and then he mentioned for Red Lydia that you're looking at essentially populations outside of what was evaluated in the pivotal cohort can you. Please just elaborate a little bit more on that.
Okay.
Let me make a couple comments on that certainly so no ideas positive patients and AML are theirs.
Numerous opportunities within our D. H positive AML patients that we're looking at earlier line for example in certain sub segments. We think are interesting just studying further somebody already in the relapsed refractory area, where we want more data.
But we're also looking at areas outside of AML, where there has been shown to have some opportunities for I D H positive.
That is a huge positive new student products, such as resin linear.
Yeah, I would just say that you know all of the patients are in <unk> in the phase two if you consider outside of the pivotal cohort I mean, some key populations that are really important to clinicians out. There include patients who were enrolled with M. D S versus say at Bell Ah patients who were enrolled treatment naive.
And patients who.
We're on combination therapy versus.
A single agent and because as you know in our pivotal cohort are it was just mono therapy and it was all relapsed refractory AML. So those are the populations that clinicians have expressed interest in.
Some of the data has been presented the combination data.
But we're looking to make sure that the other cohorts that data is out there as well for clinicians to learn from it.
And just like we did publish the postponed out of class data.
At the meeting, which I thought was very helpful. It was a question we frequently get no harm to patients who have been proven out of class perform with your product and the answer was it was very affirmative in that presentation.
Okay. Thanks, and last question for me I know you made it very clear that you're you're looking at a couple of different options on the table here in terms of next opportunities, but one that comes up pretty consistently for us as gvhd. So I know you shared some promising data earlier. This year just wondering what the next steps are for.
Following up with those patients in that program and in particular I know you haven't officially declared it hasn't next to candidates just one that you may consider thanks again.
Sure you know, it's a very attractive opportunity in the data that our colleagues are doing but we're we're able to present and publish I think is very compelling data.
Segment Bears so continues to be a important medical need and where possible that they may have a very good benefit Ah it.
It takes a little you know we're in the middle of it and evaluating that opportunity alongside other opportunities for all of a sudden it for example, and weighing one against the others as well. So we'll have to make some decisions and not of course do everything but gvhd is a very attractive one and like I said later this year, we'll come back to you and discuss how.
We're going forward with gvhd or other areas.
Yeah.
Yeah.
Thank you. Our next question is from Joe Pen goodness with H C. Wainwright. Please proceed with your question.
Hey, guys. Good afternoon play for all the details today. So I'll first role I'm just wondering if you could share maybe the maturity levels all of your discussions to potentially in license.
Yeah, I really cannot actually because I've learned I've been in business development for a long long time and until the contract is signed the contract from outside all sorts of things happen.
But needless to say Oh importantly that we're looking for chemo opportunities in late stage, either with data or at registration or just launched as opportunities that we are very interested in.
Particularly interested in opportunities that are that are a good fit with your audience is physicians, we call on but if they were slightly adjacent areas say transplant that actually made me a good opportunity as well. So we're looking at those types of opportunities a lot like width, whereas linear something that we could slot into our portfolio with really only.
Hum.
<unk> increased perhaps in infrastructure, but fully leveraging the infrastructure. We have currently in place and are you know we'd like to have these in place. So that we can obviously launch them successfully just like we're doing with video in the not that distant future. So we're looking at those type of opportunities I can't be more specific in terms of what they are or certainly nothing.
Many of that because it's just challenging until the contracts are done to announce anything in advance like that but we're.
We're excited about the continued effort to look at that we think that we have a superb chemo a commercial capability broadly speaking and we'd like to leverage that for other companies and other products. So if there's a company out there listening again that has a late stage. He most opportunity we'd be delighted to speak to you about it we have a compelling.
And why we should be your partner of choice to commercialize here in the U S. So I'll I'll add an advertisement there Joe apologies.
Slowly no totally fair enough. Thank you and then look I think the chart regarding the breakout and tabulate populations by quarter. It's extremely valuable. So I think you know obviously your goal is to continue to expand the population into earlier lines right now it appears on the chart that you're a little over 30%.
And then the second line population. So I guess you know what would you define as your key inflections steps to be able to grow those percentage numbers.
Yes.
You know what I'll ask Dave to comment on on that but let me before he does that let me say, we're delighted with the with the progress we've made you recall.
Quite a while ago when we launched this product we were predominantly Houston that later line fourth plus and now you see the evolution. It's really it's really satisfying to see the range of patients that could benefit from from salaries and and hopefully they benefit profile look like.
Yeah. So Joe let me just make sure I understand your question so 75% in the post steroid market is in second and third line. We've got approximately 70 based on or are these sort of internal numbers of patients that we know of and we have their backgrounds and we know what.
A therapy, they're odd so it represents a subset, but we've got about you know 70 or up to 75% of patients are in second and third line I think what you're saying is the second line is a relatively smaller than the third line and are we going to be able to reverse that.
And I think the answer is yeah. We think over time that will continue to get more second line use as you know that is a much more challenging because clinicians have been very used to using rituxan tito's are in that space for a long time and I think frankly that the fact that a third of our.
Patients that we are monitoring here are on a probably.
Probably in the second line setting shows that we are making progress I think that the key is for US is to get usage, where we can get any condition, where they are with their patient and when they see these results. They tend to move it up and that's what our most of you know our most loyal travel each prescribers and tell us.
Is that you know what I really liked the drag it's kind of a you know you give the patient the dose they take at their platelets go up over time and they are very happy to move it up and they see a patient says a great opportunity for top of lease and that's how we've gotten to where we are I mean, I'd say, we do have a great team out there that's.
Did it to to talking about hobbies, each and every day and I think once you saw that things had opened up a post COVID-19. Our promotional efforts that have been have been successful in getting more patients earlier in their treatment continuum. So I don't have a specific number we're trying to get to we're not trying to necessarily get too.
To that same proportion at 11400 patients in the second line would represent but yeah. We're trying to grow our second behind us, but we're also trying to make sure both second and third line are the predominant part of it.
That's very helpful and Luckily we're not testing in my short term memory now so that's good but if I'm thinking long term Davis I heard you correctly I mean, even going back a couple of years ago. You know I think you know translated your initial wish list to actual data supporting what you wanted to do being able to have patients get.
Used to the drug you know coming out of Covid happened being used to the drug seeing the refill rates based on the platelet data and what have you. So these are you know real data to look at versus the original wishes wish list you have so I appreciate it.
Absolutely we're happy to.
C D's results and provide them to you.
Thanks, guys. Thanks Joan.
Okay.
Thank you. Our next question is from Union Yang with Jefferies. Please proceed with your question.
Thank you so you.
Sure, there's a number of a bother them.
So ship till or so right.
Quarter, but can you or Tony talk about how many patients are.
Or on top of line at the end of the quarter and then also based on the L. B.
Yeah, Pavel this patient by line of therapy.
For second line, it's a little over 30% of our policy is so based on the number of eligible patients is it fair to assume that currently you have about mid single digit.
Your percentage of penetration in second line or bought.
And about 15% and 30 line. Thank you.
I'm not sure I'm quite following your math that you'd but I will say that you know fair.
First of all from a new patient perspective, we have more new patients last year, clearly more new patients last year than we've ever had in the history of the brand and we're continuing that trend this year. So we.
We don't share specific patient numbers.
But but that's but that we're very happy with our progress our consistent progress and having new patient saw it to Brad and yes. I mean this is our book of business are our best estimate based on the patients we do capture what their line of therapy is but to a project.
This over is the entire market is.
It is a it's not something I would necessarily due right. Now this is our own internal data that we're sharing and we're very happy with the trend as opposed to necessarily the specific percentages there, but the trend is clear and that's why we wanted to share it with you and it's.
It's been over several quarters, which is why we.
Sure. It earlier, we wanted to make sure it was somewhat consistent and you'll see that it begins to approach them and at this stage. There's some cabinets is a subset of patients that go through our one of our hubs and so it's not all patients out there we can't capture all patients out there.
The trends I think it's clear hopefully continue to grow though into opportunity and further growth in the second life.
Thank you.
Thank you Ian.
Thank you. Our next question from Allison <unk> with Piper Sandler. Please proceed with your question.
Thank you thanks for all the detail on today's call and thanks for taking my question, maybe first one on the pipeline just for our 289 and in lower risk Mds and that initial readout slated for this year.
Just considering that up they should should include the first three dose cohorts could you just kind of frame what you would view as a successful read out there.
And then the second following up on a prior question and prior discussion about cash burn and breakeven point could you help us maybe you don't understand what's gating to providing revenue guidance at least on the traveling right now that it's in your favor so at launch.
Should we be thinking about that the potential for that heading into next year and going forward. Thanks.
I'll ask Jim to answer the second let me try and answer the first one so the low risk Mds phase one B study is ongoing and we've.
Don just a complete enrollment of the required number in dose cohort, one and cohort two and these two.
Lower dose cohorts are still we think might be too low in terms of seeing any remarkable.
Responses in terms of efficacy there primarily safety doses, there's some chance well see some benefit in some of the.
Somebody metalogic improvements, but more likely want to see safety at least first two cohorts and so far so good and we're going to.
Discussed with FDA to allow us to go into cohort three and cohort four where we think we're more likely to see some efficacious signals efficacy signals and hopefully continued safety. So I think we hope to share. This information data at a meeting on the lower cohorts since we've already had them enrolling and we'll have further data on those.
By the end of the year. The other cohorts that we can get to enrolling those you do need to wait a number of months, maybe up to six months for showing some efficacy signals in the higher dose groups, so that might not be its certainly not this year.
It'll be more likely next year in terms of the timing of that.
Dean in terms of guidance sure sure on in terms of guidance sweep.
It is important to note that as we look at our top line, we've got Tapui switch with Sharepoint is growing consistently at a.
And a quarter over quarter consistent consistent growth pattern. So so we agree with you there that there's a there's a potential to.
Two to provide guidance with respect to that that singular number with respect to the rest of the top why as we look at AML still early in the launch phase and we've talked about a lot of activities that are going to create momentum in that in that space. We've got the royalty revenues.
And then we've got the collaboration revenues of collaboration revenues that can be.
Can be periodic certainly over time, we've highlighted.
Some of the large payments that we expect but all of those elements all factor into that top line guidance and we we don't plan to at least in the in the near term provides a topline until we really see some of that specificity and clarity as it relates to red linear so.
That's on the top line with respect to that the path to breakeven and obviously the top line is critical there and has grown suggested also as he described the possibilities with respect to.
Further development of fast Imatinib as well as the lunar sitting them as we as we really finalize with those final plans are with the advisors and the different work, we're doing we'll be able to provide more clarity on what the operating expense looks like into the future as we finalize our plans with respect to the interim.
Both studies, we plan to do.
Great. Thank you.
Thank you Allison.
Thank you. Our next question from Calpers Patel with B Riley Securities. Please proceed with your question.
Yeah, Hey, good afternoon. Thanks for taking the question one more on our $2 89.
You just mentioned that the focus there is just on safety for the first two cohorts, but would you plan on showing any sort of biomarker data I know hemoglobin.
Tends to increase early on.
Some of these competing agents.
You know it just might be useful to see any any sort of evidence of a preliminary clinical activity, even even if there is a trend.
Yep.
Just too early we haven't actually analyzed all the data yet and so we do want to share the information on the first two cohorts. So I can't make a comment because I don't know what we'll see there, but we certainly will share some of that as we get it but like I said I think a really well just need to wait until next year to see call. It three called for a data that that'll be.
More compelling data.
Okay. Okay.
Okay and then for.
For your plan to.
Potentially in license additional haemonchus assets.
Could you could you give us a little more color on how you might be thinking about financing or structuring such transactions given your current balance sheet.
Yeah, well, there's a number of options on the table for doing so and so we're looking at a range of different possibilities for that.
The important thing is that this be a late stage of opportunity that is not requiring any substantive.
Clinical type of investment and so therefore, it's a quick tightening to get to an approval and therefore to the market.
And because we hope that this and would expect that this product be a highly synergistic that is fully leveraging our current commercial capability and is not required to build more or any of substance, but it'll be accretive very quickly. After launch. So those are those are important aspects to the product but many.
Many products and he Marc here.
<unk> tends to be a multi mitch.
A category, where there are many products in smaller category like a thousand patients like before it's linear.
That's what we're looking for are to do that and therefore, we're hoping that that will help the economics up the thing, but we haven't gotten far enough to be able to articulate that the when we do announce a product. We certainly will discuss with you how we hope to finance such an acquisition.
Okay got it.
And one last question on <unk>.
On Red Lady I do you anticipate to make any milestone payments to <unk>.
Two former or no one know related to the acquisition and then in the next 12 months, maybe a commercial related milestones.
We certainly have royalty payments that we will do make and happy to make them, but I don't think there's anything of substance and certainly we'll look at it but I don't recall anything of substance in the near term.
Okay.
Got it.
Sure.
Great.
Thank you there are no further questions at this time I'd like to hand, the floor back over to Mr. Raul Rodriguez for closing comments.
Thank you operator for your help today in closing I'd like to thank everyone for joining us on the call and your continued interest in Rigel and what we're doing but I would also like to take a moment to thank our employees for their continued commitment to improving the lives of patients somewhat diseases as awful as AML, because everyday does count and they certainly keep that in there.
Minds as they worked very diligently on moving these products and projects forward. So thank you for that and look forward to keeping you updated on future calls.
Have a good afternoon or evening.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.