Q2 2021 TG Therapeutics Inc Earnings Call
[music].
Operator: Greetings. Welcome to TG Therapeutics' second quarter 2021 earnings call and business update. At this time, all participants are in a listen-only mode.
Greetings welcome to TG Therapeutics second quarter, 2021 earnings call and business update.
At this time all participants are in a listen only mode a.
Operator: The question and answer session will follow the formal presentation.
A question and answer session will follow the formal presentation.
Operator: If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad.
Operator: Please note, this conference is being recorded. At this time, I'll now turn the conference over to Jenna Bosco, Senior Vice President, Corporate Communications. Jenna, you may now begin.
This conference is being recorded.
At this time I'll now turn the conference over to Jennifer <unk> Senior Vice President Corporate Communications Jenny you May now begin.
Jenna Bosco: Thank you. Welcome, everyone, and thanks for joining us this morning.
Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the second quarter 2021 financial results and provide a business update are Michael Weiss, our chairman and Chief Executive Officer, Adam Waldman, Our Chief commercialization Officer, and Sean Power, our Chief Financial Officer.
Jenna Bosco: I'm Jenna Bosco, and with me today to discuss the second quarter 2021 financial results and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer. Following our Safe Harbor Statement, Mike will provide an overview of our recent corporate developments, as well as an update on our current pivotal programs and remaining key goals for 2021. Adam will then provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session.
Following our safe Harbor statement, Mike will provide an overview of our recent corporate developments as well as an update on our current pivotal program and remaining key goals for 2021, Adam will then provide an update on our commercialization efforts and Shawn will provide a brief overview of our financial results Richard before turning the call over to the opera.
To begin the Q&A session.
Jenna Bosco: Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory milestones, clinical development plans, and expectations for our marketed and pipelined products. TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated.
Before we begin I'd like to remind everyone that we will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995. These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance projected regulatory milestones clinical development plan.
<unk> and expectations for our marketed and pipeline products TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated.
Jenna Bosco: Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our SEC filings, including our most recent reports on Forms 10-K and 10-Q. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. All participants on this call will be in a listen-only mode. Now, I would like to turn the call over to Mike Weiss, our CEO.
Factors that may affect TG therapeutics operations include various risk factors that can be found in our SEC filings, including our most recent reports on forms 10-K and 10-Q.
In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.
We specifically disclaim any obligation to update or revise any forward looking statements.
This conference call is being recorded for audio rebroadcast on Tg's web site Www Dot TG therapeutics Dot com, where it will be available for the next 30 days all participants on this call will be on a listen only mode.
Now I would like to turn the call over to Mike Weiss our CEO.
Michael S. Weiss: Great. Thank you, Jenna.
Great. Thank you Janet and thanks to everyone for joining us today.
Michael S. Weiss: And thanks to everyone for joining us today. During the first half of 2021, we hope that our long-term goals and vision for TG have really come into focus for investors. With the first phase of our multi-phase strategy now complete, with the accelerated approval of EUCONIC, the first and only dual inhibitor of PI3K Delta and CK1 Epsilon for the treatment of relapsed or refractory morsel-zone lymphoma and Follicular Lymphoma, we are very proud of these accelerated approvals for patients who have failed prior therapies and have a limited treatment option.
During the first half of 2021 and we hope that our long term goals and vision for TG T. G I really come into focus for investors.
The first phase of our multi phased strategy now complete with the accelerated approval of Yukon. It the first and only dual inhibitor of <unk> Delta and CK 1 Epsilon.
Treatment of relapsed or refractory marginal zone lymphoma.
In Follicular lymphoma, we are very proud of these accelerated approvals for patients who have failed prior therapies and have limited treatment options.
Michael S. Weiss: We estimate approximately 8,000 patients each year will be seeking treatment in our approved MZL and follicular indications, which we see as an excellent starting point for our commercial effort. Building on the momentum from our Eukonic launch, we have submitted and received a PDUFA target goal date of March 25, 2022, for a BLA application requesting approval of the combination of Eukonics plus Oobletuximab, our novel glycoengine The combination, which we refer to as U2, for the treatment of patients with chronic lymphocytic leukemia.
We estimate approximately 8000 patients each year be seeking treatment and are approved M. C. L. In follicular indications, which we see as an excellent starting point for our commercial efforts.
Building on the momentum from our you Konica launch we have submitted and received a <unk> target goal date of March 25th 2022.
For a BLA application requesting approval of the combination of your economy plus group with talks about our novel clinical engineer anti CD 20, monoclonal antibody combination of which we refer to as you too that's.
The treatment of patients with chronic lymphocytic leukemia.
Michael S. Weiss: We have also submitted a supplemental new drug application, SNDA, for Eukonic for the same indication and have received the same PDUFA date for the SNDA. We are excited about the potential to bring our novel U2 combination to CLL patients, especially those who have failed or who are not good candidates for current standards of care. CLL is a significantly larger patient population than marginal zonic follicular.
We have also submitted a supplemental new drug application S. N D. A free economy for the same indication and have received the same producer date for the S. N D. A.
We are excited about the potential to bring our novel Youtube combination to CLO patients.
Especially those who have failed or who are not good candidates for current standards of care share.
L. L is a significantly larger patient population than marches on in Follicular. We currently estimate that approximately 30 to 40000 patients will be seeking a new treatment each year.
Michael S. Weiss: We currently estimate that approximately 30 to 40,000 patients will be seeking a new treatment each year at a proposed CLL indication. Not only is CLL a multi-fold larger patient population than marginal zonic follicular, but we would expect the median duration of treatment to be longer in CLL as well. One other important factor to note is that we believe about 85% of our target prescribers for marginal follicular lymphoma are the same prescribers that we will be targeting for chronic lymphocytic leukemia.
Cruz C O L indications.
Not only is C O L multifold larger patient population the margins on a follicular, but we would expect the median duration of treatment to be longer in C O L as well.
1 other important factor to note is that we believe about 85 per cent of our target prescribers from marginal zone Follicular lymphoma are the same prescribers that we'll be targeting that we will be targeting for chronic lymphocytic leukemia.
Michael S. Weiss: So the significant efforts our team has made in building relationships for the Mars-Los Angeles Follicular launch should translate nicely into our potential CLL launch. Next up in our multi-phased approach is the largest patient population we will be addressing, which is patients with relapsing forms of MS, with Oobatuximab as a single agent. We are targeting a BLA for MS this quarter and hope to receive a target BDUFA date in the third quarter of next year.
So the significant efforts our team has made us building relationships for the margins on a follicular launch should translate nicely into our potential C. O L watch.
Next up in our multi phased approach is the largest patient population.
We will be addressing which is patients with relapsing forms of that mess with.
Well, the tux Mab as a single agent.
We are targeting a submission of a BLA for M. S. This quarter and hope to receive a target to 3 day in the third quarter of next year.
Michael S. Weiss: We believe our Phase III data supports an attractive treatment option for patients with relapsing forms of MS. Entering MS will also raise our commercial profile significantly, as we expect to participate as one of only three anti-CD20 monoclonal antibodies in what has been projected to become a $10 to $15 billion per year market just for anti-CD20 monoclonal antibodies in the treatment of MS. Well, the core focus, will be on the regulatory and then commercial execution of these first three opportunities, especially the larger market opportunities in CLL and MS. We will continue to seek to enhance our hematology-oncology franchise by broadening the potential U2 label to new indications, such as in marginal zone and follicular lymphoma, and also into new combination uses of U2 in CLL, for example, in combination with venatoclax and our very own PG1701.
We believe our phase III data supports an attractive treatment option for patients with relapsing forms of M. S.
Entering M. S will also raise our commercial profile significantly.
We expect to participate as 1 of only 3 anti CD 20, monoclonal antibodies and what has been <unk>.
<unk> to become a $10 billion to $15 billion per year market share.
Just for anti CD 20, monoclonal antibody antibodies in the treatment of M. S.
Well the core focus will.
We'll be on the regulatory and commercial execution of these first 3 opportunities, especially the larger Parker larger market opportunities in C. O L. M. S. We will continue to seek to enhance our hematology oncology franchise by broadening the potential U 2 label to new indications such as in marginal zone Follicular lymphoma.
And also into new combination uses of Youtube in C. O. L. For example in combination with banana class and our very own T. G 17 O 1.
Michael S. Weiss: The ability to combine with standard of care agents in CLL, we hope, will bring better outcomes to patients and should also broaden the potential penetration of U2 in CLL. On the MS side, we will seek to build on ubituximab, potentially in other auto-inflammatory diseases, as well as seek to build additional programs in MS. With that said, let me provide some recent highlights related to our initial commercial launch efforts with EUCONIC and our key regulatory efforts and development programs.
The ability to combine with standard of care agents and C. O L. We hope will bring better outcomes to patients and should also broaden the potential penetration of Youtube and C O L. On.
From the M. S side, we will seek to build on Google Tux map.
Pension and other auto inflammatory diseases as well as seek to build additional programs and M. S.
With that let me provide some recent highlights related to our initial commercial launch efforts with the economy and our key regulatory efforts and development programs.
Michael S. Weiss: First, let me just remind everyone and restate that in February, the FDA granted accelerated approval of EUCONIC for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen, and for adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.
First let me just remind everyone that restate that in February the FDA granted accelerated approval of Uchronic COVID-19.
Treatment of adult patients with.
The relapsed or refractory marginal zone lymphoma, who have received at least 1 prior anti CD 20 based regimen.
And for adult patients with relapsed or refractory Follicular lymphoma, whoever received at least 3 prior lines of systemic therapy.
Michael S. Weiss: The denial was based primarily on the results from the UNITY NHL trial, which were recently published in the Journal of Clinical Oncology. On the commercial side, Eukonik became commercially available a few weeks following approval, and overall, I can say we're extremely pleased with the performance of the commercialization efforts to date. Launching during a global pandemic is no easy task, but under the circumstances, the team has done a really nice job of engaging target prescribers, both commercially and educationally, under the leadership of our Chief Commercialization Officer, Adam Waldman.
This approval.
Was based primarily on the results from the Unity NHL trial, which were recently published in the journal of clinical oncology.
On the commercial side Uchronic became commercially available a few weeks following approval and overall I can say, we're extremely pleased with the performance of the commercialization efforts to date.
Launching during a global pandemic is no easy task, but under the circumstances. The team has done a really nice job in engaging target prescribers, both commercially and educationally under the leadership of our Chief commercialization Officer, Adam Waldman.
Michael S. Weiss: Adam will join us shortly to discuss some launch metrics and give some high-level qualitative assessments of the launch thus far. I don't want to steal his thunder, but again, from where I sit, the launch is going well, and I believe it's positioning us for future success with the potential approval of U2 for CLL early next year. Speaking of which, and as noted above, the BLA and SNDA for U2 and CLL have both been granted a PDUFA target goal date of March 25, 2022.
Animals join us shortly to discuss some launch metrics and give some high level qualitative assessments of the launch thus far I.
I don't want to steal his thunder, but again from where I sit the launch is going well and believe is positioning us for future success with the potential approval of Youtube for C. O L. Early next year.
Speaking of which and as noted above the BLA and S. N D E for Youtube and CLO have both been granted a <unk> target goal date of March 25th 2022.
Michael S. Weiss: For the MS program, we were pleased in the second quarter to be able to present the positive results from our ultimate one and two phase three trials evaluating rupataximab in relapsing forms of MS at two major conferences, the American Academy of Neurology Annual Meeting and the European Academy of Neurology Annual Meeting. As mentioned during our last call, both studies met their primary endpoint, with ubatuximab treatment demonstrating a statistically significant reduction in annualized relapse rate, referred to as ARR, with ubatuximab treatment resulting in historically low levels of ARR. We believe these results are highly encouraging and showcase the potential of rubotoxinab to provide an efficacious treatment option as a one-hour infusion every six months following the first dose.
For the M. S program, we were pleased in the second quarter to be able to present the positive results from our ultimate 1 into phase III trials evaluating with Rituximab in relapsing forms of M. S. A 2 major conferences.
The American Academy of Neurology annual meeting and the European Academy of Neurology annual meeting as mentioned during our last call. Both studies met their primary endpoint with Uber Tux Mab treatment, demonstrating a statistically significant reduction in annualized relapse rate referred to as <unk>.
With all the talks about treatment, resulting in historically low levels of a R. R.
We believe these results are highly encouraging and showcase the potential of ruble tux map to provide an efficacious treatment option in a 1 hour infusion every 6 months following the first dose.
Michael S. Weiss: The expert feedback we have received thus far has been very positive, and our one-hour infusion is viewed as an important benefit for both physicians and especially their patients. These trials were conducted under special protocol assessment with the FDA, and we are on track to complete a BLA submission for lupituximab to treat RMS this quarter. And briefly, before I turn the call over to Adam, I wanted to provide a quick update on our combination and pipeline programs that we hope will be drivers of future growth, starting with U2 plus venetoclax, which has moved forward now into phase three for patients with CLL in the Ultra-V trial.
The expert feedback we have received thus far has been very positive and our 1 hour infusion is viewed as an important benefit from both physicians and it and especially their patients.
These trials were conducted under special protocol assessment with the FDA and we are at.
On track to complete a BLA submission will be tuck snap to treat RMS this quarter.
Yeah.
And briefly before I turn the call over to Adam I wanted to I had a quick update to our combination and pipeline programs that we hope will be drivers of future growth.
Starting with Youtube Klusman out of clocks, which has moved forward now into phase III for patients with C. O L. Within the Ultra V trial, the phase II portion of the Ultra V study completed enrollment earlier this year.
Michael S. Weiss: The phase two portion of the Ultra-V study completed enrollment earlier this year. You may recall that at last ASH in December, Dr. Paul Barr of the Wilmette Cancer Center in Rochester, New York presented preliminary results from his Phase I study of the U2 plus venaticlax combination, which included results from the first 27 patients in the study to complete the 12 cycles of fixed duration therapy. In those patients, there was a 100% overall response rate, and greater than 75% of the patients achieved undetectable MRD in the bone marrow.
You may recall that at last Ash in December Dr. Paul Bar of the Wilmot Cancer Center in Rochester, New York presented preliminary results from his phase 1 study of the Youtube plus man out of class combination, which included results from the first 27 patients in the study to complete the 12 cycles, a fixed duration therapy.
And those patients there was 100 per cent overall response rate and greater than 75 per cent of the patients achieved undetectable MRV in the bone marrow.
We view these results as highly encouraging and we look forward to presenting updated data from this phase 1 trial later this year with approximately double the number of patients through 12 cycles of treatment.
Michael S. Weiss: We view these results as highly encouraging, and we look forward to presenting updated data from this Phase 1 trial later this year with approximately double the number of patients through 12 cycles of treatment. Now, let's discuss TG1701, our investigational BTK inhibitor.
Next.
Let's discuss T. G 17, 1 our investigational PTK inhibitor, we were pleased to present updated results from the phase 1 trial of TG 17 of 1 as a monotherapy and in combination with U 2 last month during the summer oncology meetings, including ASKO eat Hot and I C. N. L. We were pleased to see that.
Michael S. Weiss: We were pleased to present updated results from the Phase 1 trial of TG1701 as monotherapy and in combination with U2 last month at the summer oncology meetings, including ASCO, EHOT, and ICML. We were pleased to see that in additional patients treated with TG1701, it continued to show encouraging clinical activity paired with what appears to be tolerable safety. As I mentioned earlier, we view these triple therapy trials as a way to enhance the utility of U2 in the treatment of CLL. Further in the clinical pipeline are our CD19, CD47 bispecific antibody referred to as TG1801 and our PD-L1 antibody referred to as TG1501 or Cozibelumab.
With additional patients treated with TG 17 O..1 it continued to show encouraging clinical activity paired with what appears to be a tolerable safety profile.
I mentioned earlier, we view these triple therapy trials as a way to enhance the utility of Youtube in the treatment of CLO.
Further in the clinical pipeline are our CD 19, CD 47 by specific.
Antibody referred to as TG 18, O 1 and our PD L..1 antibody refer just T. G 15, O 1 or close the Belo map both are moving through the early stages of testing with the possibility of data later this year or next.
2021that's been a very busy year for us as we've made significant progress on both the clinical and regulatory fronts and we look forward to an impactful end of year and into 2022, as we strive to expand our commercialization efforts into C. O L. M S with that I'm excited to turn the call over to our chief commercially.
Michael S. Weiss: Both are moving through the early stages of testing, with the possibility of data later this year or next. 2021 has been a very busy year for us as we've made significant progress on both the clinical and regulatory fronts and look forward to an impactful end to the year and into 2022 as we strive to expand our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Waldman, to share some highlights from our early commercialization efforts. Adam
Personalization officer, Adam Waldman.
Share some highlights from our early commercialization efforts Adam.
Yeah, Thanks, Mike and I'm very excited to provide a commercial update for the first full quarter of the Yukon ex launch let me start with the numbers and then provide some qualitative assessment.
As you've already seen in the financial press release, we achieved $1.5 million in net sales in Yukon. It for the second quarter, which was our first full quarter of sales.
Adam Waldman: Yeah, thanks, Mike. And I'm very excited to provide a commercial update for the first full quarter of the Eukonic line. Let me start with some numbers and then provide some qualitative assessment. As you've already seen in the financial press release, we achieved $1.5 million in net sales of Econics for the second quarter, which was our first full quarter of sales. While we were quite pleased with the extent of our launch penetration, which by our estimates reflects Econic capturing 3 to 4 percent of new patient starts in our labeled indication, In our view, that is a great starting point that is ahead of our internal projections.
While we were quite pleased with the extent of our launch penetration, which by our estimates reflect iconic capturing 3% to 4% of new patient starts and our labeled indications.
In our view that as a great starting point that is ahead of our internal projections importantly.
Importantly, our net sales figure doesn't fully capture the total demand from Yukon ex seen this past quarter as the amount of free uchronic provided to patients through our patient assistance program has been significant.
Many of our patients are covered by Medicare part D and their out of pocket costs are very high due to the part D benefit design in.
In addition, unfortunately, unlike C O L. Theres, a general lack of financial assistance available to support marginal zone and follicular patients with their out of pocket costs at the current time.
Adam Waldman: Importantly, our net sales figure doesn't fully capture the total demand for eukonics seen this past quarter, as the amount of free eukonics provided to patients through our patient assistance program has been significant. Many of our patients are covered by Medicare Part D, and their out-of-pocket costs are very high due to the Part D benefit design.
This dynamic is leading to a high percentage of patients qualifying to receive free products can you give me a sense of the extent from a free product offered we provided over 35% of Yukon ex bottles to patients free of charge through our patient assistance program in the second quarter.
Adam Waldman: In addition, unfortunately, unlike CLL, there is a general lack of financial assistance available to support marginal zone and follicular patients with their out-of-pocket costs at the current time. This dynamic is leading to a high percentage of patients qualifying to receive free products. To give you a sense of the extent of the free product offered, we provided over 35% of eukonic bottles to patients free of charge through our patient assistance program in the second quarter.
As we have said over and over we are committed to helping patients access our products and we're proud to be able to help those needs by providing you kotick free of charge.
When we look at the volume we may look at the the volume over overall demand, which includes free product. We are extremely pleased by the early uptake for your colleague as we've stated before our goal with this initial launches to get as many accounts prescribers and patients.
Have a positive experience with E connick as we build towards the potential CLO launch early next year, and we believe ensuring patient access is a strong step towards achieving that goal.
Adam Waldman: As we have said over and over, we are committed to helping patients access our products, and we are proud to be able to help those in need by providing Eukonics free of charge. When we look at the volume, when we look at the volume of our overall demand, which includes free products, we are extremely pleased by the early uptake of the free economy. As we've stated before, our goal with this initial launch is to get as many accounts, prescribers, and patients to have a positive experience with eConic as we build towards the potential CLL launch early next year, and we believe ensuring patient access is a strong step towards achieving that goal.
Based on these early trends and current assumptions, we are targeting 7 and a half to $12.5 million in net sales for the full year of 2021, assuming a similar rate of free goods for the remainder of the year the support you're calling for those who cannot afford it.
And further we would expect to see nice growth in our net sales for 2022 and currently we are targeting net revenues for 'twenty 'twenty 2 to be between 50, and 75 million assuming an approval of Youtube by the March 25th due for day, allowing for partial sales of Youtube in both frontline and relapsed refractory.
C O L and a small contribution from little bit talks about an M S.
Adam Waldman: Based on these early trends and current assumptions, we are targeting $7.5 to $12.5 million in net sales for the full year 2021, assuming a similar rate of free goods for the remainder of the year to support econics for those who cannot afford them. And further, we would expect to see nice growth in our net sales for 2022. And currently, we are targeting net revenues for 2022 to be between 50 and 75 million.
Which we hope to have a third quarter 2022 <unk> date.
All of which puts us on pace for our 2025 goal of achieving $1 billion in corporate wide sales.
Now let me provide some additional color beyond the numbers while it is still early into our launch we are pleased with our execution I believe we have made significant progress to date.
Our strategy has been to focus on the approximately 1000 higher volume community and academic accounts, representing approximately 3000, a hematologist oncologist, but see the vast majority of the eligible patients are indications.
Adam Waldman: Assuming an approval of U2 by the March 25th DUFA date, allowing for partial sales of U2 in both frontline and relapsed refractory TLL, and a small contribution from Ubatuxaband and MS, for which we hope to have a third quarter 2022 PDUFA date, all of which puts us on pace for our 2025 goal of achieving $1 billion in corporate-wide sales. Now, let me provide some additional color beyond the numbers.
What we have seen is that most of the initial adoption has occurred within these targeted accounts and in fact, a large percentage of the initial utilization is coming from centers that were involved in our clinical trials in many cases, we are seeing repeat prescribing at these accounts as well, which we also view as a positive sign.
And although still early we are we're pleased with the initial refill rates we are seeing.
Which we view as a reflection of both the clinical profile of your connick and that providers are effectively navigating potential toxicities and keeping patients on therapy where appropriate.
This growing experience build comfort and confidence for our expanding our prescriber base and our team is doing a fantastic job with educating and supporting clinicians and safely managing patients.
Adam Waldman: While it is still early in our launch, we are pleased with our execution and believe we have made significant progress to date. Our strategy has been to focus on the approximately 1,000 higher volume community and academic accounts, representing approximately 3,000 hematologists and oncologists that see the vast majority of the eligible patients in our indication. What we have seen is that most of the initial adoption has occurred within these targeted accounts.
We continue to receive very favorable feedback on the UK eugonic clinical profile inside.
Insights from our recent launch tracking studies show House, how show strong product performance message recall product perceptions, and importantly intensive prescribed when physicians have appropriate patients.
When our teams are engaged our target healthcare providers, they see chronic as having a differentiated profile and view it as a valuable treatment option for both relapse refractory marginal zone and Follicular patients.
Adam Waldman: And in fact, a large percentage of the initial utilization is coming from centers that were involved in our clinical trial. In many cases, we are seeing repeat prescribing at these accounts as well, which we also view as a positive sign. And although it is still early, we're pleased with the initial refill rates we are seeing, which we view as a reflection of both the clinical profile of Econics and that providers are effectively navigating potential toxicities and keeping patients on therapy where appropriate.
However, gaining access to our customers remains a challenge COVID-19 related restrictions have persisted.
Affecting our ability to access all of our targeted accounts and although the situation did improve modestly throughout the quarter with an increasing percentage of our in person engagements. The most recent trends in the Delta variant have caused some institutions to reinstitute certain visitor restrictions potentially reducing the opportunities for in person engagements in that.
How many weeks or months.
1 other important COVID-19 related trend relates to patient visits a marginal zone follicular as you know a relatively small patient populations to begin with and most physicians only see a few of these patients that fall within our labeled indications in a given year.
Adam Waldman: This growing experience builds comfort and confidence for our expanding prescriber base, and our team is doing a fantastic job of educating and supporting clinicians and safely managing patients. We continue to receive very favorable feedback on the Eukonic Clinical Profile. Insights from our recent launch tracking studies show strong product performance, message recall, product perceptions, and importantly, intent to prescribe when physicians have appropriate patients. When our teams have engaged our target healthcare providers, they see Eukonic as having a differentiated profile and view it as a valuable treatment option for both relapsed refractory marginal zone and follicular patients. However, gaining access to our customers remains a challenge.
But it appears that since the onset of Covid patient visit and treatment starts are decreasing in the lymphoma across the board.
These patients are elderly and may have been reticent to visit oncology offices. During the pandemic. We believe this continues to be an issue and we have not recovered back to prepay a day make numbers quite yet.
These trends make our initial uptake even more impressive essentially bode well for an increasing patient flow once the pandemic is behind us.
Another positive note.
Another positive note is that payer coverage has not been a challenge to date. The team has done an exceptional job here, we have been able to achieve broad coverage of iconic very quickly more than 90 per cent of commercial and Medicare lives have confirmed coverage to our label or mtc compelled yet.
Adam Waldman: COVID-related restrictions have persisted, affecting our ability to access all of our targeted accounts. And although the situation did improve modestly throughout the quarter, with an increasing percentage of our in-person engagements, the most recent trends in the Delta variant have caused some institutions to reinstitute certain visitor restrictions, potentially reducing the opportunities for in-person engagements in the coming weeks and months. One other important COVID-related trend relates to patient visits. Marginal zone and follicular, as you know, are relatively small patient populations to begin with.
We are committed to making sure that each and every eligible patient and health care provider has a positive experience with TG in Yukon like when a health care provider and their patients have a positive experience with iconic with strong educational and access support from the T. V team, we believe that the health care providers will be more likely to prescribe you chronic per additional appropriate.
Patients in the future. We also believe that this will carry through to their CLO patients assuming approval of Youtube as Mike mentioned, we estimate those roughly an 85 per cent overlap with health care providers within our target base across a lymphoma mcl now.
Adam Waldman: And most physicians only see a few of these patients that fall within our labeled indications in a given year. But it appears that since the onset of COVID, patient visits and treatment starts have decreased in endo-lymphoma across the board. Most of these patients are elderly and may have been reticent to visit oncology offices during the pandemic.
Forcing the importance of what we're doing in establishing our footprint with this launch.
So with that I'd like to thank you very much for being here and I'd like to hand, it over to Sean Palace.
Adam Waldman: We believe this continues to be an issue, and we have not recovered back to pre-pandemic numbers quite yet. These trends make our initial uptake even more impressive and potentially bode well for increasing patient flow once the pandemic is behind us. On another positive note, another positive note is that payer coverage has not been a challenge to date. The team has done an exceptional job here. We have been able to achieve broad coverage of Econic very quickly.
Thank you Adam and thanks, everyone again for joining us.
Earlier. This morning, we reported our detailed second quarter 2021 financial results, which can be viewed on the investors and media section of our corporate website.
For today's call I'll keep my remarks remarks brief and touch on a few highlights from the quarter beginning with our cash position.
We ended the second quarter with approximately $456 million in cash cash equivalents and investment securities, which we believe will be sufficient to take us into 2023.
Adam Waldman: More than 90% of commercial Medicare lives have confirmed coverage for our label or NCCN compendia. We are committed to making sure that each and every eligible patient and health care provider has a positive experience with TG and Eukonic. When a healthcare provider and their patient have a positive experience with Eukonic, with strong educational and access support from the TG team, we believe that the healthcare provider will be more likely to prescribe Eukonic for additional appropriate patients in the future.
As Adam noted earlier, we were pleased to report $1.5 million of Uchronic net product revenue in the second quarter.
First full quarter of product sales.
Our net loss for the second quarter of 2021, excluding noncash items was approximately $62 million.
Which was a decrease of $12 million quarter over quarter from Q1 of 2021, where we saw a net loss excluding non cash items of approximately $74 million.
Yeah.
Given that Q1 of this year was our first quarter fully commercial entity is probably a more apples to apples comparison to what we saw this quarter.
Adam Waldman: We also believe that this will carry through to their CLL patients, assuming approval of U2. As Mike mentioned, we estimate there's roughly an 85% overlap of health care providers within our target base across lymphoma and CLL.
As compared to the first quarter of 2021, the decrease of approximately $12 million.
Primarily driven by 1 time licensing milestone payments of approximately 14 million occurring in Q1 of this year.
Adam Waldman: We're reinforcing the importance of what we're doing and establishing our footprint with this launch. So with that, I'd like to thank you very much for being here, and I'd like to hand it over to Sean Power. Thank you, Adam, and thank everyone again for joining us.
If we compare this quarter to Q2 of 2020, where we saw a net loss and net loss, excluding noncash items of approximately $46 million.
That increase was primarily related to increased selling general and administrative expenses associated with the launch of your chronic and planning for potential future launches of Youtube and C O L and Uber Tux Mab and RMS.
Sean A. Power: Earlier this morning, we reported our detailed second quarter 2021 financial results, which can be viewed in the investors and media section of our corporate website. For today's call, I'll keep my remarks brief and touch on a few highlights from the quarter, beginning with our cash. We ended the second quarter with approximately $456 million in cash, cash equivalents, and investment securities, which we believe will be sufficient to take us into 2023.
Our GAAP net loss for the second quarter of 2021 inclusive of non cash items was $78.5 million or 59 cents per share compared to a net loss of $52.9 million or <unk> 47 per share during the comparable quarter in 2020.
With that I'll now call turn the call back over to the conference operator to begin the Q&A.
Thank you.
At this time I will now be conducting a question and answer session. If you'd like to ask a question. Please press star 1 on your telephone keypad and a confirmation tone indicate your line is in the question queue.
Sean A. Power: As Adam noted earlier, we were pleased to report $1.5 million of Uconnec net product revenue in the second quarter, our first full quarter of product. Our net loss for the second quarter of 2021, excluding non-cash items, was approximately $62 million, which was a decrease of $12 million quarter over quarter from Q1 of 2021, where we saw a net loss excluding non-cash items of approximately $74 million. Given that Q1 of this year was our first quarter as a fully commercial entity, it's probably a more apples-to-apples comparison to what we saw this quarter.
You May press star 2 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 keys.
1 moment, please while we poll for questions.
Yeah.
Thank you and our first question is from the line of Alicia Young with Cantor Fitzgerald. Please proceed with your questions.
Hey, guys. Thanks for taking my questions and congrats from the early progress with the launch maybe.
Maybe just a couple from me 1 just.
I wanted to get a little bit more color about how you were talking about doing kind of the COVID-19 trends just how much penetration has occurred into the roughly around I guess 3000, heme ox, you now and kind of how's that kind of ebbed and flowed like it sounded like it might start to slow a little bit in line with Delta variant and then my second question is just as far as a differentiated clinical profile like an mcl in follicular.
Especially on the safety I just wanted to get some color around you know how does how's that going in and some of the early experience I know, it's still super early but just any kind of color you can provide there and then.
Sean A. Power: As compared to the first quarter of 2021, the decrease of approximately $12 million was primarily driven by one-time licensing milestone payments of approximately $14 million occurring in Q1 of this year. If we shift and compare this quarter to Q2 of 2020, where we saw a net loss excluding non-cash items of approximately $46 million, that increase is primarily related to increased selling, general, and administrative expenses associated with the launch of Econics and planning for the potential future launches of U2 in CLL and UbuntuxMab in RMS.
I was intrigued by kind of the when you said the 2025.1 billion.
Like can you give us a little bit of framework about how to think about what that breakout might be between like you know multiple sclerosis and in the hematology indications. Thanks.
Yeah.
Yeah.
Okay.
Yeah sure Mike do you want me to take those.
Hello.
Yeah.
Shoot I'm sorry, yes, yes, please Adam I was on mute, Okay [laughter], Okay, Yeah, Alicia Thank you Ed.
Doing this in the AR.
Over the line is there is a little tough so sorry. So the first question around penetration. We are we are you know I think given the pandemic.
Sean A. Power: Our gap net loss for the second quarter of 2021, inclusive of non-cash items, was $78.5 million, or $0.59 per share, compared to a net loss of $52.9 million, or $0.47 per share, during the comparable quarter in 2020.
And as I've mentioned before we've we've hired a really experienced team that came in here with relationships and our existing connections.
So our penetration has been very good, especially in the top centers. The issue is with just with frequency and just how often you get into these centers.
And with a new product it does take multiple visits sometimes to discuss the full.
Operator: With that, I'll now turn the call back over to the conference operator to begin the Q&A. Thank you. At this time, we'll now be conducting the question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question. For dispensers using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions.
Profiled the mechanism.
The patient populations and it does take some time with so so to answer your question penetration has been good especially into the top accounts, we're working on frequency.
We're starting to see that and as I mentioned things did get modestly better in <unk>.
Second quarter, we were seeing increases in live engagements.
Which we think is the more effective way of communicating however, with the Delta variant in the last few weeks, we are seeing a reversal of those trends.
Operator: Thank you. And our first question is from the line of Alicia.
Alicia: with Cantor Fitzgerald. Hey, guys, thanks for taking my questions and congrats on the early progress with the launch. Maybe just a couple for me. One, I wanted to get a little bit more color about how you were talking about during kind of the COVID trend, just how much penetration has occurred into the roughly around, I guess, 3,000 hemox. You know, kind of how that kind of ebbed and flowed, like, or it sounded like it might start to flow a little bit in light of the Delta variant.
And so it's getting we're starting to see you know cancer centers start to restrict.
Live engagements again, so we'll have to watch that and see how it goes but in general we feel like live engagements are better our penetration has been good but obviously, it's a fluid situation.
Alicia can you remind me of the second question Oh feedback on like kind of the years, you know as far as the safety differentiation that can be seen with <unk>.
Alicia: And then my second question is just, as far as a differentiated clinical profile, like an MZL and follicular, especially on safety, I just wanted to get some color around how that's going and some of the early experience. I know it's still super early, but just any kind of color you can provide there.
Yeah, I mean, the feedback has been really positive.
On the profile they see it as very differentiated as I mentioned before the lack of a black box warning as is.
<unk> is a differentiating versus the other 3 case out there.
And I think you know it just takes time for when they see a patient and when a patient presents themselves and you know these these patients don't show up on an individual physician basis.
Alicia: And then I was intrigued by kind of the 2025, 1 billion in sales. Like, can you give us a little bit of a framework about how to think about what that breakout might be between, like, you know, multiple sclerosis and the hematology indications thing? Yeah, sure, Mike, do you want me to take those? Hello? Shoot, I'm sorry. Yes, yes, please. I was on mute.
That often throughout the year, so when we're able to get good frequency of.
Interaction and a patient shows up that's when we're getting use but the feedback on the product has been very very positive.
And then as far as the breakdown in the 1 billion.
Michael S. Weiss: Okay. Okay. Yeah. Thank you. I'm doing this in the, "Over the line" is a little tough. So, sorry.
I mentioned.
Adam Waldman: So, the first question around penetration, we are, you know, I think, given the pandemic, we're, and as I've mentioned before, we hired a really experienced team that came in here with relationships and existing connections. So, our penetration has been very good, especially in the top centers. The issue is just frequency and just how often you can get into these centers, you know, and with a new product, it does take multiple visits sometimes to discuss the full profile, the mechanism, the patient populations, and it does take some time.
We expect a small contribution from en masse given that we're expecting a late in the year approval there.
We expect to get some contribution from you to given that we would have 3 quarters of abuse.
Abuse of Utah up approval and our ability to promote you'd see when CLO.
Starting in the second quarter is our expectation.
And then.
You know the continued launch of margin zone until the killer will continue to form the base.
Of the revenue projections.
Alicia just to clarify I, Adam was referring to 2022 and his answer.
Adam Waldman: So, to answer your question, penetration has been good, especially into the top accounts. We're working on frequency. We're starting to see that, as I mentioned, things did get modestly better in the second quarter. We were seeing increases in live engagement, which we think is a more effective way of communicating. However, with the Delta variant in the last few weeks, we are seeing a reversal of those trends. And so it's getting, we're starting to see, you know, cancer centers start to restrict live engagement again.
Oh got it yeah sorry.
Oh that was that was just wondering.
What are the $1 billion in 2025, I don't think.
John as far as to say that but I think yeah I think at that point, we should be in a 50.50 are trending toward a larger contribution from M. S at that point.
Okay models that we haven't forecast or there is some flex between bull and bear cases, and so I think where we're giving ourselves a little bit of flexibility there as well.
Okay Cool I guess, just a follow up just you know you talked about these 8000 follicular in mcl, which I mean could be a sizable opportunity itself. So I guess I'm just trying to get a feel between 2022 and 25 you know how confident you are in being able to kind of penetrate this core group over time.
Adam Waldman: So we'll have to watch that and see how it goes. But in general, we feel like live engagements are better. Our penetration has been good, but obviously, it's a fluid situation. Aletha, can you remind me of the second question?
Yeah, I mean, I think in terms of Marzano follicular.
Feel pretty good about the potential for penetration again, it yeah, I don't I don't know what peak penetration expectations are overall, but I mean, I think if we were you know 20% to 30% penetration that would be pretty fantastic and any group, where there's multiple drugs available.
Adam Waldman: Oh, feedback on, like, the kind of use, you know, as far as the safety differentiation that could be seen, would you...
Awesome great. Thank you.
Adam Waldman: Yeah, I mean, the feedback has been really positive on the profile. They see it as very differentiated.
The next question comes from the line of Josh <unk> with Evercore ISI. Please proceed with your questions.
Adam Waldman: As I mentioned before, the lack of a black box warning is seen as differentiating versus the other PI3Ks out there. And I think, you know, it just takes time for when they see a patient and when a patient presents themselves. And, you know, these patients don't show up on an individual physician's basis that often throughout the year. So when we're able to get a good frequency of interaction and a patient shows up, that's when we get used to it. But the feedback on the product has been very, very positive.
Great. Thanks, so much from for taking the questions first on reimbursement and access how do you expect it to evolve from here for your kind of core for you too are the reasons to expect it will improve and if so what would those reasons be.
Pathway for full approval of your current I can what do you expect it will take to achieve that and then lastly, maybe you could talk or even considered kind of rank ordering the obstacles to uchronic adoption how much of it is COVID-19 how much does reimbursement how much of it is awareness how much is competitive therapies and how do you think.
Adam Waldman: And then, as far as the breakdown in the $1 billion, you know, as I mentioned, we expect a small contribution from MS, given that we're expecting a late-year approval there. We expect to get some contribution from U2, given that we would have three quarters of use of the approval and our ability to promote U2 and CLL, starting in the second quarter. And then, you know, the continued launch of Marginal Zone and Follicular will continue to form the base of revenue.
Those obstacles me alleviate in the coming months and years. Thank you.
Yeah, I don't want to go ahead, with some reimbursement access and where you see things heading.
Sure Yeah. Thanks for the question Josh.
The access and reimbursement front, we really havent seen many challenges I think as I mentioned, we have.
Adam Waldman: Aletheia, just to clarify, Adam was referring to 2022 in his answer. Oh, 2022. Oh, I got it. Yeah. Sorry. That was for the 1 billion in 2025. I don't think we've gone as far as to say that. But I think, you know, I think at that point, we should be at a 50-50 or trending toward a larger contribution from MS at that point. Okay. The models that we have in Forecaster, there is some flux between, you know, bull and bear cases, and so I think we're giving ourselves a little bit of flexibility there as well. Okay.
Achieve broad coverage for.
The broad payer coverage and are not experiencing any issues with regards to that.
I think what you may be getting too well.
Well, we can clarify, but that's I think we're good on the access and reimbursement side.
Hum.
I'll take the obstacles and competitive.
I'll, let you Mike talk about the full approval.
Yeah, No I think the obstacles you know yeah, I mean, much as Mike mentioned in his remarks launching in a pandemic is difficult.
You know when we get in front of physicians as I mentioned, they're there.
We have a very positive feedback on the product, but that's when we get in front of them and we're continuing to make progress there.
Adam Waldman: Okay, cool. I guess just to follow up, you talked about these 8,000 follicular cells in MZL, which could be a sizable opportunity itself. So I guess I was just trying to get a feel between 2022 and 2025, you know, how confident you are in being able to kind of penetrate this core group over time.
And when we have those interactions they are largely very positive interactions and from our market research that shows that they see it as a differentiated product in and 1 in which is very compelling for marginal zone and follicular patients in our in our indications.
You know there is a I think the obstacles are the COVID-19 and just getting access.
Adam Waldman: Yeah, I mean, in terms of marjolaine follicular, we feel pretty good about the potential for penetration. Again, I don't know what peak penetration expectations are overall, but I think if we were, you know, 20 to 30 percent penetration, that would be pretty fantastic in any group where there are multiple drugs available.
I think there is some decrease in patient visits of patient treatment starts just given the reticence of some patients as I mentioned coming in to start a new treatment.
And I think those would be the biggest challenges and I think they will hopefully alleviate when we get further down the line and get away from the pandemic going forward.
Operator: Awesome. Great.
Operator: The next question comes from the line of Josh Schimmer with Evercore ISI. Please answer your question.
And and Josh on the pathway for full approval of Yukon, Inc.
Joshua Elliott Schimmer: Thanks so much for taking the questions. First, on reimbursement and access.
So.
I guess 2.2 points 1 the CLO Muni D. C O L trial will ideally support a full approval of <unk> C. L. L. A and then converting the margins on Follicular.
Joshua Elliott Schimmer: How do you expect it to evolve from here for UConn?
Joshua Elliott Schimmer: or for you two, what are the reasons to expect it will improve, and if so, what would those reasons be?
Accelerated approval into a full approval will require a randomized trial that we're in the process of finalizing the.
Joshua Elliott Schimmer: If you could discuss the pathway for full approval of EUCONIC and what you expect it will take to achieve that. And then last, maybe you could talk or even consider some kind of rank.
The design win with the F D a and hopefully that study will commence before before yearend. The concept there would be some some trial that will be in.
Joshua Elliott Schimmer: Ordering the obstacles to eukonic adoption, how much of it is COVID, how much is reimbursement,
Slightly earlier lines of Follicular.
And then randomized trial with that with your chronic.
Joshua Elliott Schimmer: COVID, how much of it is reimbursement, how much of it is awareness, how much of it is competitive therapies, and how you think those obstacles may be overcome in the coming months and years. Thank you.
Adam maybe you can kind of clarify on the reimbursement with 35% free drug but is that something you expect to continue or whether that may improve going forward and if so why.
Yeah, I gotcha, okay.
Adam Waldman: Adam, why don't you go ahead with some reimbursement access and where you see things heading? Thanks for the question, Josh.
Have a good to clarify so yeah, I mean, you know in marginal zone Follicular specifically.
We're seeing a general lack of co pay support our funds available for Medicare part D patients.
Adam Waldman: On the access and reimbursement front, we really haven't seen many challenges. I think, as I mentioned, we have achieved broad coverage, broad payer coverage, and are not experiencing any issues with regard to that. I think what you may be getting to, well, we can clarify, but I think we're good on the access and reimbursement side. I'll take the obstacles and competitive issues, and I'll let you, Mike, talk about the full approval.
A large part of the a large percentage of our patients in this specific indication our Medicare part D over the age of 65.
And specifically in larger than Follicular, where we're not seeing a availability of co pay funds.
Do expect that that would change with C O L. We see.
See much more funding available in CLO.
And this is much less of an issue in C O L.
And then M S as a different a different ballgame altogether, we're talking about largely commercial patients. So it's not as relevant.
Adam Waldman: You know, I think the obstacles, you know, yeah, I mean, launching, as Mike mentioned in his remarks, launching in a pandemic is difficult. You know, when we get in front of physicians, as I mentioned, they have very positive feedback on the product, but that's when we get in front of them, and we're continuing to make progress there. And when we have those interactions, they are largely very positive interactions, and from our market research, it shows that they see it as a differentiated product and one that is very compelling for marginal zone and follicular patients in our education.
But so we would expect this to persist for this year.
And then as we get into CLO, we would expect it to come down as a as an overall issue given the funding that's available in that patient population.
Thanks very much.
Thanks, Josh.
Thank you. Our next question is from the line of Eric Joseph with Jpmorgan. Please proceed with your question.
Adam Waldman: Um, you know, there is, uh, I think the obstacles are COVID and just getting access. Uh, I think there is, uh, some decrease in patient visits or patient treatment starts, just given the reticence of some patients, as I mentioned, coming in to start a new treatment. And, um, you know, I think those are the, uh, the biggest challenges, and I think they will, uh, hopefully, alleviate when we get, uh, further down the line, get away from the pandemic, going forward. And Josh, on the pathway for full approval of UConn. Um, so I guess I'll give them two points.
Uh huh.
Good morning, Thanks for taking our questions.
The first is around your 'twenty takes you sales guidance I'm, just wondering what that it creates in terms of CLO penetration and whether there is any anticipated impact to chronic net price as combo therapy as opposed to use a single agent.
Marginal zone, and then I'd also be curious.
Get a sense of what your latest thinking is around the European commercial and regulatory strategies across the different franchises and people like Rms.
Thanks.
Yeah.
Okay.
Thanks, Eric.
Adam joined take a crack and crack the first 1.
Yeah got once you start and then I'll Oh.
I'll weigh in.
Michael S. Weiss: One, the CLL, the Unity CLL trial will ideally support a full approval of eukonic and CLL. And then converting the margins of follicular accelerated approval into a full approval will require a randomized trial that we're in the process of finalizing with the FDA. And hopefully, that study will commence before year-end. The concept there will be some trials that will be in slightly earlier lines of follicular, and then randomized trials with Eukonics.
Yeah. So you know in terms of a CLO in terms of penetration I think where we're assuming given the point in time of the year that will get launch which will be probably into the second quarter.
There'll be obviously some contribution from CLO in our in the year.
In terms of the the amount of penetration.
I think were even using even more modest penetration numbers. Then then we found that we were seeing right now with <unk>.
Adam Waldman: Adam, maybe you can kind of clarify on the reimbursement, the 35% free drug, whether that... Transcripts provided by Transcription Outsourcing, LLC. Yeah, I gotcha. Okay.
Connick.
In N M zone, Follicular and so we've been pretty conservative.
In those in those assessments.
And then in terms of your kind of pricing as part of the package yeah.
Adam Waldman: Yeah, I gotcha. Okay, yeah.
Adam Waldman: Good to clarify. So yeah, I mean, you know, in marginals on follicular specifically, we're seeing a general lack of copay support funds available for Medicare Part D patients. A large percentage of our patients in this specific indication are Medicare Part D patients over the age of 65, and specifically in large events follicular where we are not seeing availability of copay funds.
We have not moving not finalized.
Pricing it so it's hard for us to give too much detail because again I don't think anyone knows what the.
From giving any guidance on the go with Hudson Mab.
Pricing.
Adam Waldman: We do expect that that will change with CLL. We see much more funding available for CLL, and this is much less of an issue in CLL. And then MS is a different ballgame altogether.
But it's.
The most likely will be.
Some discounting to 2 tonic in that setting.
But it's really it will become a function of of what we are.
Adam Waldman: We're talking about largely commercial patients, so not as relevant. But so, you know, we would expect this to persist for this year. And then, as we get into CLL, we would expect it to come down as an overall issue, given the funding that's available in that patient population. Thanks very much.
What we price, where we price of the Tux Nab in.
Total price that we think is it's there.
Sure.
From a patient population.
Got it.
Second.
So the latest.
Approaching the European commercial Robert Lee, perhaps with the.
Yeah.
Operator: Our next question is from the line of Eric Joseph with J.P. Morgan. Good morning, thanks for taking the questions. The first is around your 2022 sales guidance. I'm just wondering what that anticipates in terms of CLL penetration and whether there is any anticipated impact to buconic net price as a combo therapy as opposed to use of single agent and molecular marginal zone. And then I'd also be curious to get a sense of what your latest thinking is around the European or EU commercial and regulatory strategies across the different franchises, both in human legacy as well as RMS. Thanks. Thanks, Eric. Adam, do you want to take a crack at the first one?
Various product franchises.
Yeah, So where we are in the process of scoping that out still we're we're moving forward.
Hum.
With that I think we're working toward.
The first application.
Hmm.
Yeah.
I kind of go back and check with the regulatory team, but the first application in the in Europe may be a N M S.
So we may actually end up staging at EMS first and in CLO second there.
But I think I need to probably get back to you.
On that but we are definitely moving forward, we think that the M S opportunity in Europe.
Is it is a very interesting 1 for us and when they are.
Managed probably more cleanly.
With a smaller team.
Certainly then moving very required in the U S and net pricing in Europe will be a big driver of uptake. So we're still exploring that to make sure that those assumptions are valid.
Eric William Joseph: Yeah, why don't you start and then I'll... [inaudible] Yeah, so in terms of CLL and in terms of penetration, I think we're assuming given the point in time of the year that we'll get launched, which will probably be into the second quarter, that there'll obviously be some contribution from CLL throughout the year. In terms of the amount of penetration, you know, I think we're even using even more modest penetration numbers than we found that we're seeing right now with eukonic in MZL and follicular. And so, you know, we've been pretty conservative in those assessments.
But assuming that's the case, we think there's a pretty interesting opportunity for a free European loss launch an M S.
We're still continuing to scope out how that.
Pricing interplay with C O L. A will occur so I think for the moment.
I'm.
Pretty sure we're going to head forward with that with M. S. A first and then CLO second ex U S.
Adam Waldman: And then in terms of the eukonic pricing as part of the package, yeah, we have not finalized pricing yet, so it's hard for us to give too much detail because, again, I don't think anyone knows what the final price will be. We haven't given any guidance on the ovotuximab pricing. But it's, but there will probably be some discounting to eukonic in that setting, but it's really, it will become a function of what we price where we price it over Tuxnav and will come together to basically come up with a total price that we think is fair. Patient Population
Okay. Okay, great. Thanks for taking my questions appreciate it.
Sure.
The next question is from the line of Chris Howerton with Jefferies. Please proceed with your questions.
Great. Thanks, so much for taking the questions and congratulations on all the progress.
Thanks Anthony.
As of course.
First with respect to the Youtube plus fanatical ex trials I guess I couldn't quite remember what the regulatory path is would the phase 2 study would be sufficient for an accelerated approval opportunity.
Michael S. Weiss: For the latest on approaching the European commercial opportunity perhaps with the various product franchises. Yeah, so we're, we're in the process of scoping that out still. We're, we're moving forward with what I think we're working towards. I think the first application, don't... Yeah, I think I've got to go back and check with the regulatory team. But the first application in Europe may be in MS. So we may actually end up staging it in MS first and then CLL second there, but I think I need to probably get back to you on that, but we are definitely moving forward.
I guess, it's just a pretty simple question and then.
With respect to the phase 2 study itself.
What would be the expected data disclosure I know there was at least in my head some anticipation that we would get those some of the data at ash, but might not be the full results. So I guess some thinking around that would be helpful. And then the last question was.
Michael S. Weiss: We think that, you know, the MS opportunity in Europe is a very interesting one for us and one that's.., managed probably more cleanly with a smaller team, certainly than we required in the U.S. and that pricing in Europe will be a big driver of uptake, so we're still exploring that to make sure that those assumptions are valid, but assuming that's the case, we think there's a pretty interesting opportunity for a European launch at MS, while we're still continuing to scope out, you know, how that pricing interplay with CLL will occur, so I think for the moment, I'm pretty sure we're going to head forward with MS first, and then CLL second, actually.
Ensuring that everything is good to go with respect to C. N N C, particularly as it relates to EBIT texting, Matt. Thank you.
Sure.
So in terms of the Youtube then program.
We've been a we've been focused on 3.
3 full phases right. So we have a phase 1 that.
That Dr. Paul Barr conducted.
Is the lead investigator in that phase 1 is where we is what we presented previously at last year's Ash and it's what we've been committing to present.
Operator: Okay, okay. Great. Thanks for taking the questions. Appreciate it. The next questions are in the line from Chris Howerton with Jeffries. Please take your questions.
Later, this year and update you so.
I think we had 27 patients through 12 months. The first go around and we're looking for somewhere between 40 and 50 patients.
Operator: Great, thanks so much for taking the questions. Congratulations on the progress. I think for me, the ash, of course.
Through 12 months for the completion of the patients in that trial. So.
Chris Howerton: First, with respect to the U2 plus Phenateclex trials, I guess I couldn't quite remember what the regulatory pathway was.
That is the that is the Youtube then data that we've been talking about is being presented later this year in terms of Ultra V. As we've said the enrollment completed early in earlier this year into the phase 2 portion.
Chris Howerton: Accelerated Approval Opportunity. I guess it's just a pretty simple question.
Chris Howerton: And then, you know, with respect to the Phase 2 study itself, what would be the expected data disclosure? I know there was, at least in my head, some anticipation that we would get some of the data at ASH, but it might not be the full result. So I guess some thinking around that would be helpful. And then the last question was, you know, just ensuring that everything is good to go with respect to
And so that data.
To have all of the patients through 12 months.
Would not occur until after well after ash and in fact, we would need to be prepared for as you'd need probably 2 months prior data so.
The the ultra V data set as I've noted multiple times would be incomplete for this as a and if we can present, a partial data set or.
Chris Howerton: CMNC, particularly as it relates to ooblatexamab. Thank you.
Michael S. Weiss: So, in terms of the YouTube Venn program, we've been focused on three, almost three full phases, right? So, we had a phase one that Dr. Paul Barr conducted as a lead investigator, and that phase one is where we presented previously at last year's ASH, and it's what we've been committing to present later this year, an update on. I think we had 27 patients through 12 months in the first go-around, and we're looking for somewhere in between 40 and 50 patients through 12 months for the completion of the patients in that trial. That is the U2 Venn data that we've been talking about as being presented later this year.
Or not it was really a function of what the principal investigator wanted to do.
And so we're still trying to figure that out today, what it will do a partial data set.
But yeah. My my general feeling is that it probably will not occur. This year is and I've said this in multiple occasions. If it were if it were me and I was the pie and we were that close to the new Italian all patients through 12 months.
I wouldn't want to release the partial set when I can do a full set.
Within a reasonable timeframe of that so we'll wait to hear back from the P. I and what his decision is but I think from where I said I wouldn't be surprised at all in fact I'd be surprised if he said he wanted to present the partial data set from let's say, let's see where it goes but for the moment.
Michael S. Weiss: In terms of Ultra V, as we've said, the enrollment completed early in, earlier this year in the Phase 2 portion. And so that data, to have all the patients through 12 months would not occur until after, well after ASH. And in fact, we would need, to be prepared for ASH, you'd need probably two months of data prior.
The phase 1 is where we will see the Youtube then data later this year and ultra V is more likely than not.
We're gonna be a more complete dataset.
Next year.
And then in terms of the regulatory side of that question.
Michael S. Weiss: The Ultra V data set, as I've noted multiple times, would be incomplete for this ask, and whether we could present a partial data set or not was really a function of what the principal investigator wanted to do. And so we're still trying to figure that out today, whether we'll do a partial data set. But my general feeling is that it probably will not occur this year, and I've said this on multiple occasions. If it were me and I was the PI, and we were that close to having all patients through 12 months, I wouldn't want to release a partial set when I could do a full set within a reasonable time frame.
Once we have the full phase II data are.
Through through the <unk>.
At least all the patients through the 12 months.
Timeframe.
We'll look at that data and we will have a conversation with the F D. A.
Ideally you too will be approved at that time.
So hopefully we'll have a.
An easier pathway for from the FDA approval of new to already being approved and banana costs already being approved.
As we've said multiple times is theres no assurance.
That that phase II data.
I'll be usable for for approval if it is not usable for approval of course.
Michael S. Weiss: So we'll wait to hear back from the PI and what his decision is, but from where I stand, I wouldn't be surprised at all, and in fact, I'd be surprised if he said he wanted to present the partial data set. We'll see.
The phase 2 portion will be published most certainly.
Send it over to C N N and see if they're interested in adding it to their guidelines.
And the phase III is enrolling as we speak so that's the current status of that program.
Michael S. Weiss: At the moment, phase one is where we'll see the U2 Venn data later this year, and Ultra V is more likely than not going to be a more complete data set next year. In terms of the regulatory side of that question, once we have the full Phase 2 data through, at least all the patients through the 12-month timeframe. We'll look at that data, and we'll have a conversation with the FDA.
Great.
That's awesome and then I guess, just any anything to note on CMC.
Nothing nothing to note that that you know we filed the CMC.
Uh huh.
It was the first section we filed as part of the rolling submission for the types of map.
For the CLO application from Mobley and.
My knowledge, there's been a.
Dialogue back and forth. The FDA has been reviewing that file.
Michael S. Weiss: Ideally, U2 will be approved at that time, so hopefully it'll have an easier pathway from the FDA to approval because U2 is already approved, and Vanadaclip's already approved. But as we've said multiple times, there's no assurance that that Phase 2 data will be usable for approval. If it is not usable for approval, of course, the Phase 2 portion will be published. We'll certainly send it over to NCCN and see if they're interested in adding it to their guidelines. And Phase 3 is enrolling as we speak. So that's the current status of it.
And as typical you know of any filing those there's questions that come in and go back out to the F. D. A and that is the process that is ongoing but nothing.
Nothing nothing to the teams great concern as far as I as far as I know okay.
Fantastic well. Thank you Mike I appreciate it and hope to talk to you soon.
Thanks, Chris.
Okay.
The next question is from the line of Ed White with H C. Wainwright. Please proceed with your question.
Good morning, Thanks for taking my questions.
So maybe the first question too Sean.
Chris Howerton: Great. Okay, that's awesome. And then I guess just anything to note on CMNC?
Some guidance on SG&A expenses trending higher.
Michael S. Weiss: Nothing to note, we filed the CMC, I think it was the first section we filed as part of the rolling submission for the CLL application for OOBLEE and to my knowledge there has been a dialogue back and forth, the FDA has been reviewing that file and as typical of any filing there's questions that come in and go back out to the FDA and that is the process that is ongoing but nothing to the team's great concern as far as I know. Fantastic.
Was wondering if you could make any comments on R&D I know there were several the $4 million charge in the quarter.
But how should we be thinking about the.
The second half of this year.
Sure. Thanks, Ed.
So SG&A trended higher over last year over last second quarter of course as you would expect.
Given the commercial launch I think it'll it'll continue to tick up a little bit over the course of.
Operator: Fantastic. Well, thank you, Mike. I appreciate it, and I hope to talk to you soon. Thanks, Chris. The next question is from the line of Ed White with H.C. Wainwright. Please answer your question.
The rest of this year as I said as we prepare for the CLO and M S launches.
And I wouldn't I wouldn't expect all to all that much on the on the R&D from I would say.
Edward Patrick White: Good morning. Thanks for taking my question. So maybe the first question for Sean, you gave some guidance on SE&A expenses trending higher. I was wondering if you could make any comments on R&D. I know there was the $4 million charge in the quarter, but how should we be thinking about the second half of this year? Sure. Thanks, Ed.
Not a whole lot of volatility there over the remainder of the year.
Yeah.
Okay, great. Thank you.
And then Mike just some pipeline questions.
<unk> commented on Ultra V phase 2.
Can you give us any update on how the phase 3 enrollment is going.
Sean A. Power: So SG&A trended higher last year, and in the second quarter, of course, as you'd expect, given the commercial launch. I think it'll continue to pick up a little bit over the course of the rest of this year, as I said, as we prepare the CLL and MS launches. And I wouldn't expect all that much on the R&D front. I would say there won't be a whole lot of volatility there over the remainder of the year.
Are there any trends you can look at now to let US know when you think the trial will be fully enrolled.
And then.
You had mentioned data later on here for the phase 1 trial.
I'm just wondering for the other combinations and drugs in development.
What we could potentially see at ash this year.
Edward Patrick White: And then, Mike, just from.
Sure. So in terms of full enrollment into ultra V. It's way too early unfortunately to give any kind of projection.
Michael S. Weiss: Mike, just some pipeline questions. You had just commented on Ultra-V Phase 2. Can you give us any update on how the enrollment in Phase 3 is going? Are there any trends you can look at now to let us know when you think the trial will be fully enrolled? And then... You mentioned data later in the year for the phase one trial. I'm just wondering about the other combinations and drugs in development, you know, what we could potentially see at ASH this year.
You know enrollment when we started about a month or 2 ago. So it's we're in very early days for early stage of a trial, it's going quite well.
But obviously, we're going to.
Got to see a big ramp at some point and and then I'll have a better sense of what the target enrollment timeframe would be for that.
In terms of.
Data from the rest of the pipeline for later this year.
Michael S. Weiss: Sure, so in terms of full enrollment into Ultravated, it's way too early, unfortunately, to give any kind of good projection. You know, enrollment only started about a month or two ago. So it's, we're in the very early days for this stage of a trial. It's going quite well, but obviously, we're gonna, you know, we got to see a big ramp at some point and then have a better sense of what the target enrollment timeframe would be for that.
Yeah, certainly we continue to enroll more patients in and the 17, 1 study and the PTK.
So that 1 will continue to to eat.
Peak out data and all the conferences keep people updated on the progress of that program.
And then with a C. D 47, C 19, and 15 O 1.
You know those are there's a continued 2 to be in the early stages and we are again I cannot promise data this year as I noted.
Michael S. Weiss: In terms of data from the rest of the pipeline for later this year, certainly, we continue to enroll more patients in the 1701 study in BTK, so that one will continue to eke out data at all the conferences and keep people updated on the progress of that program. And then with CD47, C19, and 1501, you know, those are continuing to be in the early stages.
Essentially later this year for sure next year I mean.
We will have certainly something present by next year, but the potential for later this year.
So I think in terms of what to expect during the remainder of this year.
The I'll put them close the final data from the phase 1 of Youtube plus then we will see.
Michael S. Weiss: And we, again, I cannot promise data this year, as I noted, potentially later this year, for sure next year. We will certainly have something presented by next year, but the potential for later this year. So, I think in terms of what to expect during the remainder of this year, I'll put in quotes, the final data from phase one of U2 plus Venn, we'll see sometime later this year, more up-to-date, more updated data on 17.01. Okay, thanks, Mike.
Sometime later this year more up to date.
David Day down 17, 1.
To come out and I'm sure. There's I know the team is working on.
Sub analysis of all the different trials. So there's other things that people are working on but in terms of datasets that you have visibility out for the moment I think those are probably the 2 the 2 primary datasets that are they remaining and like I said, some sub analysis that will be coming out with.
Okay. Thanks, Mike and then my final question is you mentioned when you were talking about at MFS.
Edward Patrick White: And then my final question is, you mentioned when you were talking about MS, other auto-inflammatory disease indications and other forms of MS. I was just worrying, you know; how should we be thinking about that potential? Should we be seeing potential studies start next year, or is this, you know, further down the road? I think it's possible to see some studies start next year. We're working on a few concepts, and if they come to fruition, then yeah, I would expect some things to start, some studies to start next year. I will keep you posted for sure.
Other autoimmune inflammatory disease indications and other forms of MFS.
I was just wondering.
How should we be thinking about that potential should we be seeing.
Potential study start and in next year or is this further down the road than that.
I mean anything is possible to see some studies starting next year, where we're working on a few concepts and if they come to fruition then yeah I would expect.
Some things to 2 stars from studies to start next year.
Well keep you posted for sure.
Operator: Our next question is from the line of Greg Serena with Golden Sachs. Please answer your question.
Okay. Thanks, Mike.
Thanks, Dan.
Our next question is from the line of Greg Savannah with Goldman Sachs. Please proceed with your questions.
Greg Serena: Yeah, thanks. Good morning.
Yeah. Thanks, Good morning, I've got a couple of questions. If I could 1 just on your connick and it might be too early for you to comment but can you provide an.
Greg Serena: I've got a couple of questions, if I could. One, just on Eukonic, and it might be too early for you to comment, but can you provide an update on the number of accounts that you've penetrated? And this might certainly be too early, but if you're seeing any reordering, I'm just trying to get a sense of what the ordering pattern dynamic might be for Eukonic. And then a follow-up on Eukonic is, you know, it seems as if the way you're positioning the product relative to the portfolio is that it's, you know, a very good product for patients and prescribers to get an overall good experience with TG Therapeutics.
An update on.
Number of accounts that you've.
Penetrated.
And if this might certainly be too early but if youre seeing any reordering I'm just trying to get a sense of what the ordering pattern dynamic might be for your connick.
And then a follow up on your Connick is it seems as if the way you're positioning the product relative to the portfolio was at its you know bear.
Very good product for patients and prescribers to get an overall good experience with TG therapeutics and with.
Greg Serena: And with that in mind, I was wondering if you might be comfortable providing what you currently believe the peak revenue opportunity of Eukonic might be. And then, moving beyond Eukonic, just looking at the MS landscape, any color that you might be able to provide would be appreciated, just on what you're seeing in the anti-CD20 marketplace. Obviously, you've got Okvus there, and Kesimpta is relatively new, but just wondering if you can comment on just how you're seeing Kesimpta, you know, and that launch and how that's having an impact either on Okvus alone or just the overall anti-CD20 market in general. Thanks.
With that in mind I was wondering if you might be comfortable providing what you currently believe peak revenue opportunity if you connick might.
It might be.
And then moving beyond you kind of just looking at the EMS landscape any color.
That you might be able to provide would be appreciated just on what youre seeing in the anti CD 20 marketplace. Obviously, you've got oak risks there and cause symptoms is relatively new but just wondering if you can comment on just how you're seeing cause them to hum.
<unk> launch and how that's having an impact.
<unk> either on Okra this alone or just the overall anti CD 20 market from general Thanks.
Adam Waldman: Sure. Actually, Adam, do you want to start with the last question? We'll work our way backwards through. There are some questions about accounts and reordering on the Econics side, but maybe, while that question is fresh, some MS commentary. Yeah, sure. Yeah, we just saw, I think Roshan Navarish just had a conference call last week. There was some dialogue around their launch there, so we're looking at that. It looks like there was some recovery, you know, from earlier in the pandemic.
Sure.
Actually Adam you're going to start the the last question will work our way backwards through there's some questions about accounts from reordering on the accounting side, but maybe well that question is fresh maybe some EMS commentary.
Yeah sure Yeah, we just saw.
I think Roche and Novartis, just just had a conference call last week there was some.
Dialog around their their launch there. So we're looking at that it looks like there was some recovery.
From.
Earlier on the pandemic looks like they are continuing to get some traction in.
Adam Waldman: Looks like they're continuing to get some traction in the anti-COVID-20 space. The class itself is on a growth trend. Kassimta is getting some traction in the market, but both seem to be holding steady, and it's not growing now again, you know, as the pandemic continues on here.
In the anti CD 20 space that the class itself is on a growth trend.
Since it is getting some traction in the market, but both seem to be holding steady and it's not growing now again.
As the pandemic continues on here, but.
Adam Waldman: So we're encouraged by it. I think, you know, the physicians that we talked to continue to be very excited about the class, excited about the use of the product earlier and earlier in arresting the disease. So we think it's good trends overall and that the class itself is growing, which we think is very positive.
So we're encouraged by it I think our you know the physicians that we talk to continue to be very excited.
Excited about the class I'm excited about the use of the product earlier and earlier in a rush.
<unk> the disease. So we think it's a good trends overall and that the.
The class itself is growing which we think is very positive.
Let me talk about the economy I think the first question was around accounts and reordering as I mentioned you know we.
Adam Waldman: I think the first question was around accounts and reordering. As I mentioned, you know, where we're seeing usage is in our top accounts, in the highest volume accounts. The split that we're seeing is about 60-40 academic to community.
We are seeing where we're seeing usage is in our top accounts in.
In the highest volume accounts the split that we're seeing is about 60.40 academic community.
Adam Waldman: We're seeing, we are seeing reordering from accounts. We don't have the specificity, as a lot of it's going through specialty distributors, so we don't have the, you know, the preciseness that we'd like to and perhaps we'll look into for future calls. But, you know, as I mentioned, we're getting good penetration in our top accounts, and most of our usage is coming from there, and we are seeing reordering. And then I think there was a question around peak revenue, I think it was specifically for Eukonic, and I don't know if that question was around Marginal Zone Follicular specifically.
We're seeing we are seeing reordering from from accounts. We don't have the specificity is a lot of it is going through.
Specialty distributors, so we don't have the.
Precise in this that we'd like to and perhaps will look into for for future calls but.
As I mentioned, we're getting good penetration of our top accounts in most of our usage is coming from there.
And we are seeing a reordering.
And then I think there was a question around peak revenue in I think it was specifically for you Connick and I don't know if that question was around marginal zone Follicular specifically.
Adam Waldman: But you know, our view on that has not changed. We still see this as being a significant revenue opportunity. You know, I think, Mike, remind me what we've said in the past. Yeah. Yeah. So I'll take that one.
But you know our our our view on that has not changed we still see this as being a significant revenue opportunity I think.
Mike remind me what we've said in the past yeah, yeah. So I'll take that 1 so so in terms of the.
Michael S. Weiss: So in terms of the positioning of Eukonic and MZLN Follicular as a way for us to introduce TG to the world, that's, you know, that's been something that we said a year before the launch, six months before the launch, at the launch, and now four months after the launch. We continue to believe that the Eukonic introduction, Marginal Zone Follicular, is, you know, most important is not about revenues. It's about, you know, introducing TG and Eukonics for future impact, primarily CLL.
The positioning of your comic and M zone Follicular as they basically as it is a way for us to introduce T G to a to the world.
That's you know that's been something that we've said.
A year before the law in 6 months before the launch out the launch and now 4 months after the launch.
We continue to believe that.
The the Yukon introduction marginal and Follicular is most most important is not about revenues, it's about introducing introducing TG eugonic for future.
Impact primarily CLO and he said that consistently we've said, we think it's still marginal and follicular. It could be a you know a few.
Michael S. Weiss: And we've consistently said that consistently, we've said we think it's still Marginal Zone Follicular could be, you know, a few hundred million dollar revenue opportunity over time. I think that, you know, remember, we're taking away almost 40% of all sales right now. And if that's a trend that continues, you know, that's a pretty big discount.
A few hundred million dollar revenue opportunity over time, I think that you know.
Remember, where we're taking away almost 40% of all sales right now and if that's a trend that continues.
That's a pretty big discount, but again, we think certainly at the point in which there's a few hundred million dollars of of revenue potential.
Michael S. Weiss: But again, we think certainly at the point in which there's a few hundred million dollars of revenue potential, TG could be in a position to help fund, hopefully with others, charitable organizations that can provide support for those patients. So I think it's, you know, at these levels, it's interesting to see that, you know, we're giving away so much for Eukonic. But like I said, we made it very clear that we wanted to have a great experience for Eukonic at Marginal Zone Follicular. And you know, we did not anticipate giving away almost 40% of the free goods.
D G could be in a position to 2 <unk>.
Fun with hopefully with the others charitable organizations that can provide them.
Support for those patients so I think it's.
At these levels, it's interesting to see that we're giving away so much free eugonic.
But like I said, we made this very clear that we wanted them to have a great <unk>.
Experience for Ya Connick, Ingmar zone, Follicular, and we did not anticipate giving away almost 40% free goods.
Adam Waldman: But having said that, that's fine. We're happy to do it if it builds goodwill in the industry and we want to make sure patients all have access. So I think in terms of the consistency of that message, we've been extremely consistent about where we're positioning this launch. Again, having said that, You know, I think in terms of the penetration that we've seen, we've exceeded our expectations, certainly from the launch phase of Marzona Follicular, but we are going to be built on the impression and the positive feedback we get from the iconic launch of Marzona Follicular.
But having said that that's fine we're happy to do it if it if it builds goodwill in the industry and we want to make sure patients all have access so I think in terms of.
The consistency of that message, we've been extremely consistent about where we are positioning this launch.
Hum.
Again, having said that.
I think in terms of penetration that we've seen we exceed.
We exceeded our expectations.
To date and I think if we continue to grow.
In this marketplace and achieve somewhere in the order of 20 per cent to maybe even as high as 30% spending on them.
In a bull scenario.
Adam Waldman: Yeah, and Craig, just do... clarify that my comments on the reordering We're seeing reordering both in terms of multiple patients from the same accounts, and we're seeing reordering in terms of, you know, refills as well so
Marzano Follicular, a few hundred million dollar opportunity again.
We've never and we continue to say that the company is not being built.
On the back of that revenue is from certainly from the launch phase of <unk> zone, Follicular, but we are going to be built on the impression and the positive feedback we get.
From the iconic launch and marginal and Follicular.
Operator: The next question is coming from the line of Matt Kaplan with Lenberg-Selman. Please proceed with your question.
Yeah, and Craig just to.
Clarify that the.
My my comments on the reordering, we're seeing reordering both in terms of a multiple patients from the same accounts and we're seeing a reordering.
Matthew Lee Kaplan: Hey, good morning, guys. And thanks for taking the questions. Just a little follow-up on the Ultra V program. Can you give us some more color, I guess, on the Ultra V Phase 3 study design? Other specifically, are there any differences from the Phase 2 portion of the study? So the Phase 3 study design is U2 plus Venn versus U2. In terms of the actual treatment with U2 plus Venn, the, um...
In terms of.
Refills as well so.
Just wanted to clarify.
Okay. Thanks for that.
Thanks, Greg.
The next question is coming from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Hey, good morning, guys and thanks for taking my questions.
A little follow up on the Ultra deep program can you give us some more color I guess from the Ultra V Phase III study design. Other specifically are there any differences from the phase 2 portion of the study.
Matthew Lee Kaplan: I'll have to double check for you, Matt, but I think we may be using potentially up to three months more of Venn than we used in the..., in the Phase 2 portion, but that was only, again, just to match up with the current schedule for Venn. Let me just double check for you, but otherwise, not much in terms of difference.
So the phase 3.
Our study design is Youtube plus band versus you too.
In terms of the.
The actual treatment with Youtube plus then.
The.
You've got a double check from that but I think we may be using potentially up to 3 months more of than.
Then we used in the ER.
In the in the phase 2 portion, but that was only again just to match up with the current schedule for that so let me just double check for you, but otherwise.
Michael S. Weiss: Helpful. And then, with respect to your BTK inhibitor program 1701, you presented some, you know, positive data recently at medical meetings. What are your current thoughts on the regulatory path forward? Have you identified, I guess, paths or pathways for the product? Can you continue to develop it? Yeah, I mean we feel really good about that molecule. The performance has been, you know, quite impressive.
And then not much in terms of differences.
Right.
Helpful and then with respect to your PTK inhibitor program 17 O 1.
You presented some positive data recently at the medical meetings what are your current thoughts on the regulatory path forward have you identified I guess counter pathways for the product and continuing to develop it.
Yeah, I mean, we feel really good about.
That that molecule the.
The performance has been quite impressive.
Michael S. Weiss: You know, we've spent a lot of time trying to understand the differences between the doses and in terms of tolerability. Our goal has and continues to be to try to identify the most tolerable, you know, most tolerable regimen to make sure we have the most tolerable BTK inhibitor. So we're working hard on that. In terms of the phase 3 program, the registration, we've had a few good opportunities. We haven't picked the one yet, but I would expect, you know, by early next year we'll be in phase 3 for 1701. Okay, very good.
And a lot of time trying to understand the differences between the doses and in terms of Tolerability profile on our goal has and continues to be to try to identify.
The most tolerable.
Yeah, well, it's all about regimen to make sure we have the most tolerable PTK inhibitor. So we're working hard on that.
In terms of the the phase 3 program the registration.
Got a few good opportunities we haven't picked the 1 yet but.
But I would expect by early next year, we'll be in a in a phase III for 17 on line.
Okay. Okay, and then I guess last week, it's a little follow up on on sales and it's a question with respect to autoimmune indications additional autoimmune indications for Botox man, what a beyond M. S. What what's your current thinking in terms of where where are you going to bring the product next.
Michael S. Weiss: And then I guess last week, it was a little follow-up on Ed's question with respect to autoimmune indications, additional autoimmune indications for Oobatoxinab. Beyond MS, what's your current thinking in terms of where you're going to bring the product next? Yeah, we haven't given any guidance on that yet, Matt, but we're scoping out a number of different opportunities. And as soon as we have some in place, we'll certainly disclose those. Well, congrats on your recent progress and thanks for taking the question.
Yeah, we haven't given any guidance on that yet in that book, where we're scoping out a number of different opportunities and as soon as we have something in place, we'll certainly disclose those.
Well congrats on the recent progress and thanks for taking the questions.
Operator: Thank you. Our final question is from the line of...
Thanks, Matt.
Thank you.
Final question is from the line of my own from a tiny with B Riley Securities. Please proceed with your questions.
Operator: Our final question is from the line of Mayank Mamtani with BeRiley Securities. Good morning team, thanks for taking our questions and I appreciate the helpful detail here. So just a quick one, Adam, on the econic launch: any early color on, you know, what the real world discontinuation and maybe progression rate might be just to, you know, I know it's early days, but just to get a handle on what the duration of therapy might be. And then I have a couple of quick follow-ups.
Good morning team, thanks for taking our questions and appreciate the helpful detail here. So just a quick 1 Adam on the Eugonic launch.
Any early color on you know.
But the real wood discontinuation and and and maybe progression rate might be just do you know.
I know, it's early days, but just to get a handle on what the duration of therapy might be and then I have a couple of quick follow ups.
Mayank Mamtani: Yeah, thanks for the question, Mayank. But no, you know...
Yeah. Thanks for the question Mike No you know its a I think it's too early honestly too early to comment on that.
Adam Waldman: No, you know, it's I think it's too early, honestly, to comment on that. You know, we're Yeah, it's just too early to comment on that. Okay, great. And then, Mike, on the near and long-term guidance that, you know, was very helpful, any color on that?
Yes, it's just too early to comment on line.
Okay, Okay great.
And then Mike on the near and long term guidance that you know it was very helpful.
Mayank Mamtani: Any color on, you know, the path to profitability, number one, and then also on the 2025 number for sales, does that include a partner for MS sales?
Any color on the path to profitability number 1 and then also on the 2025 number for sales does that include a partner for that Miss sales.
Michael S. Weiss: And in terms of a path to profitability, you know, again, I think, you know, If we achieve our goal of 2025, 1 billion in sales, my guess is, well, we should be profitable.
It does not include a partner for M S sales.
And in terms of our path to profitability you know again I think yeah.
If we achieve our goal.
Of our 2025.1 billion in sales my guesses will you shouldn't be profitable by them.
Mayank Mamtani: Okay, great. And just on the pipeline side, you know, anything next we should expect to hear about the CD19, CD47, and maybe a program you don't talk about much, but you know, IRAC-IV is of increasing interest to investors. So, you know, when and what we may expect to hear about those two programs, if you could. Yeah, so in terms of IRAC4, you know, we've been pretty clear that that program is probably not moving forward. And I'm hoping, like I said, to have data later this year, if not later this year, then into next year.
Okay, Great and then just.
On the pipeline side, you know any any anything next we should expect to hear for the CD 19, CD 47, and maybe a program you don't talk about much but you know I'd ask what is of increasing interest to investors. So.
Vanda and and what we May expect to hear on those 2 programs. If you may.
Yeah. So in terms of Iraq for we've been pretty clear that that program is probably not moving forward for.
For some time now.
In terms of the CD 47, CD 19.
Uh huh.
That 1 is moving forward nicely, where we've just opened up the U S and hopefully.
Hopefully like I said to have data later this year if not later this year then into next year.
Michael S. Weiss: Okay, thanks, Mike, and congrats again on the program.
Okay. Thanks, Thanks, Mike.
And congrats again on the progress.
Michael S. Weiss: Thank you. We've reached the end of the question and answer session, and I'll now turn the call over to Mike Weiss for closing remarks.
Thank you.
Thank you we've reached the end of the question and answer session and I'll now turn the call over to Mike Weiss for closing remarks.
Michael S. Weiss: Great. Thank you very much and thanks everyone again. So, I just want to wrap up today's call by once again reviewing our upcoming key goals and objectives. So, clearly, we're going to continue to focus on the commercialization efforts of eukonic and relapsed refractory marzozonin follicular and expand those commercial capabilities in preparation for a potential launch of U2 and CLL and also, of course, for ulbituximab in relapsing forms of MS. We are working hard towards submitting our BLA for ulbituximab in the treatment of relapsing forms of MS this quarter.
Great. Thank you very much and and thanks, everyone again, so just wanted to wrap up today's call by once again review, our upcoming key goals and objectives.
So clearly we're going to continue to focus on the commercialization efforts of your connick in relapsed refractory marginal zone Follicular and.
And expand those commercial capabilities and.
In preparation for potential launch in of Youtube in Cielo and also of course for <unk> in relapsing forms of MFS.
We are working hard towards submitting our BLA for older touch from having the treatment of relapsing forms of M. S. In this quarter.
Michael S. Weiss: And that, of course, as everyone knows, is based on the positive results from the ultimate one and two phase three trials. In terms of continuing enrollment into studies, obviously, we're going to push hard on enrollment into the UltraView phase three trial and enrollment into our 1701 phase two, and hopefully soon to start a TG1701 phase three trial early next year, and continue to push forward with the pipeline of 1501, which is the PD-L1, and 1801 is the CD-47, and CD-19.
And then of course as everyone knows is based on the.
Positive results from the ultimate 1 and 2 phase II trials.
In terms of.
Continuing enrollment into study is obviously, we're going to push hard on the enrollment into the ultra V phase III trial.
And enrollment into our 17.1.
Phase 2 and <unk> and hopefully soon to start a T. G 17 in 1 phase II trial early next year.
And continue to push forward with the pipeline of 15, 1 which is the PDL, 1 and 18 I wanted to CD 47, CD 19.
Michael S. Weiss: We've talked at length today about the potential data presentations for later this year. And, you know, we are working hard, I can tell you, working very hard to obtain the approval for U2 and CLL by the PDUFA goal date of March 25, 2022. So, on behalf of all of us at TG, I'd like to thank everyone for joining us today, and have a great day.
We are you know.
Talked to at.
At length today about the potential data presentations for later this year.
And you know we are working hard I can tell you working very hard.
To obtain the approval for you 2 and C. O L. By the <unk> date of March 25th 2022, So on behalf of all of US at T. G. I would like to thank everyone for joining us today and have a great day.
Operator: Thank you to everyone joining us today. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
Thank you everyone. Joining us today. This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Yeah.