Q3 2021 TG Therapeutics Inc Earnings Call

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Greetings and welcome to the TG Therapeutics third quarter 2021 earnings call and business update at this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.

Operator: and welcome to the TG Therapeutics third quarter 2021 earnings call and business updates. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Star Zero on your telephone keypad.

Operator: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Senior Vice President of Corporate Communications. Thank you, Jenna. You may begin.

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Jenna Bosco Senior Vice President Corporate Communications. Thank you you may begin.

Jenna Bosco: Thank you. Welcome everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the third 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 provide an update on the current pivotal programs and key remaining 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.

Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the third 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 provide an update on the current pivotal programs and keep remaining goals for 2020. One Adam will then provide an update on our commercialization efforts and Shawn will provide a brief overview of our financial results before turning the call.

Over to the operator to begin the Q&A session.

Jenna Bosco: Before we begin, I'd like to remind everyone that we'll be making some 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 operations and financial performance, including sales performance, projected regulatory milestones, clinical development plans, and expectations for our marketed and pipeline products. CG 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'll be making some 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 operations and financial.

Performance, including sales performance projected regulatory milestones clinical development plans and expectations for our marketed and pipeline products.

<unk> 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 GG Therapeutics' operations include various risk factors that can be found in our SEC filings, including our most recent reports on forms 10K and 10Q. 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 website at www.gtherapeutics.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 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 website at 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 CTO.

Michael S. Weiss: Thank you, Jenna, and good morning, everybody, and thanks for joining us. 2021 has been a pivotal year for TG as we transitioned from a purely development stage company into a fully integrated commercial organization. With the launch of Eukonic and the continued build of our commercial platform, TG has grown tremendously this year. I'm incredibly impressed with the team we've built and excited to see everyone working so closely together toward our common goal of developing and commercializing novel treatments for patients with B-cell diseases.

Thank you Jennifer and good morning, everybody and thanks for joining US 2021 has been a pivotal year for T. G. As we transitioned from a purely development stage company into a fully integrated commercial organization.

With the launch of your chronic and the continued build of our commercial platform P. G has grown tremendously this year.

Credibly impressed with the team we've built and excited to see everyone working so closely together toward our common goal of developing and commercializing novel treatments for patients with B cell diseases.

Michael S. Weiss: The team's hard work and effort this year have established our commercial footprint that I believe will pay dividends in the coming years as we intend to leverage our commercial platform for multiple potential future launches, including, of course, U2 and CLL and UBLTuxman Abb and RMS, both of which we are targeting for 2020. And beyond that, from our robust B-cell pipeline that we will touch briefly on later. Since this call is occurring hot off the heels of our live participation in the consortium of multiple sclerosis clinics' annual meeting, referred to as CMSC, and as abstracts won't be available for another 20 minutes or so, I thought I'd kick off the call by discussing our multiple sclerosis program.

The teams hard work and effort.

This year have establish a commercial footprint that I believe will pay dividends in the coming years as we intend to leverage our commercial platform for multiple potential future launches, including of course, you Chew and C. O L and we'll talk to you about that RMS both of which we are targeting for.

22022.

And beyond that from a robust b cell pipeline that we will touch briefly on later.

This call is occurring hot off the heels of our lives participation and the consortium of multiple sclerosis clinics annual meeting.

Referred to as C N S C.

And ash abstracts won't be available for another 20 minutes or so.

I thought I'd kick off the call by discussing our multiple sclerosis program, perhaps the most exciting news from this past quarter was that we completed a biologics license application or BLA.

Michael S. Weiss: Perhaps the most exciting news from this past quarter was that we completed our Biologics License Application, or BLA, Submission to the US FDA for oobotoxymab, a glyco-engineered, anti-CD20, monocolonial antibody to treat patients with relapsing forms of MS. We submitted this application in late September, and we look forward to hearing back from the FDA in late November on whether they have accepted this application for filing. Assuming all goes well, we would anticipate a target producer date in late September of 2022.

Submission to the U S F D a.

Lets them out.

Glycol engineer anti CD 20, monoclonal antibody to treat patients with relapsing forms of M. S.

We submitted this application in late September and we look forward to hearing back from the FDA in late November and whether they have accepted this application for filing.

Assuming all goes well, we would anticipate a target date in late September of 'twenty to 'twenty two.

Michael S. Weiss: This task quarter, we also presented at the XTrums conference and shared additional data from the ultimate one and two phase three trials, which supported our BLA submission to the FDA. As a reminder, these trials were conducted under special protocol assessment with the FDA, and importantly, as noted in the past, both studies met their primary endpoint, with Ubotoxymap treatment demonstrating a statistically significant reduction in annualized relapse rate, sometimes referred to as ARR, with Oblatoxysmap treatment resulting in historically low levels of annualized relapse rate.

This past quarter. We also presented at the <unk> conference and shared additional data from the ultimate one and two phase III trials.

Wardrobe BLA submission to the FDA as a.

A reminder, these trials were conducted under special protocol assessment with the FDA and <unk>.

Importantly, as noted in the past both studies met their primary endpoint with Botox nuc treatment, demonstrating a statistically significant reduction in annualized relapse rate, sometimes referred to as a R. R.

With all the talks about treatment, resulting in historically low levels of annualized relapse rate as.

Michael S. Weiss: At the FTrums meeting, we also shared data on additional secondary, tertiary, and even some post hoc endpoints to offer the MS community additional color around the highly successful primary endpoint. We believe the additional data presented further demonstrates the potential benefit of bupatoxamab to treat patients with RMS with a one-hour infusion every six months following the initial starting dose. As a reminder, we also hosted a virtual event during the Ektrums conference, and I encourage anyone who is interested in TG to go to our website, listen to a recording of that event, and listen to the KOLs provide their thoughts on UbTouchNab and the data presented thus far.

That's the F turns meeting we also shared data on additional secondary tertiary and even some post hoc endpoints to offer the M. S community additional color around the highly successful primary endpoint. We believe the additional data presented further demonstrates the potential benefit of Hooper talk snap to treat patients with.

Our mess with a one hour infusion every six months following the initial starting dose.

As a reminder, we also hosted a virtual event during the <unk> conference and I encourage anyone who's interested in TGE to go to our website.

To listen to a recording of this event.

And listened to the Kols provide their thoughts on Hooper touch that and.

And the data presented thus far Furthermore, at the recent C. M. S. C annual meeting I personally had the opportunity to meet with a number of key opinion leaders and I have to say the feedback was overwhelmingly positive and provide a tremendous insights help us best positioned with Rituxan up for success and M. S.

Michael S. Weiss: Furthermore, at the recent CMSE annual meeting, I personally had the opportunity to meet with a number of key opinion leaders, and I have to say the feedback was overwhelmingly positive and provided tremendous insights to help us best position buctomab for success in MS. Next, let's review the Unity CLL Phase 3 program. As you may recall, we submitted and received a PDFA goal date of March 25, 2022 for a BLA and an S-NDA, requesting approval of the combination of eukonic acid plus Ubutoxinab, for those of you who know, referred to as the U2 combination, for treatment of patients with CLL.

Next let's review the M D C O L Phase III program as you May recall, we submitted and received a particular goal date of March 25th 2022 for a BLA and an S. N D. A requesting approval of the combination of your conic plus Super Tucks in Nab.

So those you knew referred to as the Youtube combination for treatment of patients with CLO. These.

Michael S. Weiss: These applications are supported by the data from the Unity CLL Phase 3 program, which achieved its primary endpoint and showed patients treated with U2 achieved a statistically significant improvement in progression-free survival as compared to patients who received chemoimmueth therapy. This trial was conducted under a special protocol assessment with the FDA. With many CLL patients seeking a new treatment each year, we are excited about the potential to leverage the commercial platform we built this year around Econic to commercialize you two for patients with CLL, if approved.

These applications were supported by the data from the Unity <unk> Phase three program, which achieved its primary endpoint and showed patients treated with you two achieved a statistically significant improvement in progression free survival as compared to patients who received chemo immunotherapy.

This trial was conducted under a special protocol assessment with the FDA.

With menu CLO patients seeking a new treatment each year, we are excited about the potential to leverage the commercial platform. We built this year around your conic two commercialized Youtube patients with C. O L. If approved in particular for those patients who may not be good candidates for current standards of care as well as that.

Michael S. Weiss: In particular, for those patients who may not be good candidates for current standards of care, as well as those who have failed other currently available options and are in need of an alternative treatment. Now, let me turn to Eukonic.

<unk>, who have failed currently available options and are in need of an alternative treatment.

Now, let me turn to the economy as a reminder, in February of this year. The FDA granted accelerated approval with the economy as a single agent for the treatment of adult patients with relapsed or refractory marginal zone lymphoma.

Michael S. Weiss: As a reminder, in February of this year, the FDA granted accelerated approval of Econic as a single agent for the treatment of adult patients with relapsed or refractory marginal zoma who have received at least one prior anti-CD20 base regimen. And for adult patients with relapsing or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. Disapproval was based primarily on the results from the Unity NHL trial, which were subsequently published in the Journal of Clinical Oncology.

Who have received at least one prior anti CD 20 base regimen and for adult patients with relapsed or refractory Follicular lymphoma, who have received at least three prior lines of systemic therapy.

This approval was based primarily on the results from the Unity NHL trial, which were subsequently published in the journal of clinical oncology.

Michael S. Weiss: As for the launch, I'll keep my comments brief and let our chief commercialization officer, Alan Walman, provide the details. Despite the challenges posed by COVID, I've been very pleased with the performance of our team. I got a chance to meet most of our sales team in person recently, and I have to say, what an impressive group of professionals with vast experience working hard to establish our commercial footprint by introducing Yukonic and TG to the broader community of oncologists.

As for the launch I'll keep my comments brief and let our chief commercialization Officer, Alan Woman's provides the details.

Despite the challenges posed by Covid I've been very pleased with the performance of our team I got a chance to meet most of our sales team in person recently and I have to say, what an impressive group true professionals with vast experience working hard to establish our commercial footprint by introducing new conic and T G to the broader community.

And colleges.

Michael S. Weiss: One of the team's key goals has been to educate and build awareness among as many healthcare professionals who treat MZL and follicular as possible, keeping in mind that most of our current target prescribers are also the clinicians who treat patients with CLL. So all the hard work building the prescriber base with experience with single-agent Eukonic and MDL and follicular should bolster our launch efforts for U2 and CLL if approved Through their efforts, our teams have engaged live and virtually thousands of healthcare providers, and the Econic prescriber base continues to grow. And importantly, we are seeing increasing uptake in community practices, which we believe will be integral for the potential success of you too.

One of the teams key goals has been to educate and build awareness with as many health care professionals, who treat M. E. L. F follicular as possible keeping in mind that most of our current toward the prescribers are also the clinicians who treat patients with C. L.

So all of the hard work building prescriber base with experience with single agent Uchronic in N V. L. In Follicular should bolster our launch efforts for you two and C O L. If approved.

Through their efforts our teams have engaged live in virtually thousands of health care providers and the economy Prescriber base continues to grow and importantly, we are seeing increasing uptake in community practices, which we believe will be integral for the potential success of Youtube.

Michael S. Weiss: Lastly, I wanted to spend a few minutes discussing a couple of additional pipeline programs that we hope will drive better outcomes for patients and become future drivers of growth and expansion of a hematology oncology commercial platform, starting with YouTube Plus Fanatic.

Lastly, I wanted to spend a few minutes discussing a couple of additional pipeline programs, which we hope will drive better outcomes for patients and become future drivers of growth and expansion of our hematology oncology commercial platform.

Starting with Youtube placement out across as a reminder, the ultra V phase III trial evaluating this triple combination is now enrolling patients with treatment naive and relapsed or refractory CLO.

Michael S. Weiss: As a reminder, the Ultra V phase three trial evaluating this triple combination is now enrolling patients with treatment naive and relapsed CLL. The phase two portion of this study completed enrollment with approximately 165 patients earlier this year. Most recently, at the IWCL Conference, Dr. Paul Barr of the Wilmot Cancer Center in Rochester, New York, presented updated results from his phase one U2 plus vet combination study, which now includes approximately 47 patients treated with the triplet regimen.

The phase two portion of the study completed enrollment with approximately 165 patients earlier this year.

Most recently at the IW Cielo conference Dr. Paul Bar of the Walmart Cancer Center in Rochester, New York presented updated results from these phase one Youtube was about in combination, which now includes approximately 47 patients treated with the triplet regimen.

Michael S. Weiss: Best overall response was 100% among valuable patients, including a 37% complete response rate. Importantly, at cycle 12, 91% of the 34 patients achieved undetectable minimal residual disease in the peripheral blood, and 72% of 32 patients achieved undetectable minimal residual disease in the bone marrow.

Best overall response was 100% among evaluable patients, including a 37% complete response rate.

Importantly, it cycled 12, 91% of the 34 patients achieved undetectable minimal residual disease in the peripheral blood and 72% of 32 patients achieved undetectable minimal residual disease in the bone marrow.

Michael S. Weiss: We see these data as highly encouraging, and we look forward to providing updates from the phase one and phase two studies next year. Also, at IWCLL, we presented data on TG1701 on an investigational BTK inhibitor as a monotherapy and as a triple combination with U2. We were pleased to see that in additional patients, TG1701 continues to show encouraging clinical activity paired with what appears to be a tolerable safety profile. Also, important to note, we hosted a virtual event during the IWCL conference, and again, I encourage those of you who are interested in TG to go to our website and listen to the feedback directly given by the KOLs about this novel regimen.

We see these data is highly encouraging and we look forward to providing updates from the phase one and phase two studies next year.

Also and I WCS O L. We presented data on P. G 17 O one our investigational PTK inhibitor as a monotherapy and as a triple combination with you too.

We were pleased to see that with additional patients T. G 17 O. One continued to show encouraging clinical activity.

With what appears to be a tolerable safety profile.

Also important to note we hosted a virtual event during the Iwc All conference and again I encourage those of you who are interested in T. G to go to our website and listen to the feedback directly given by the Kols about this novel regimens.

Michael S. Weiss: These are exciting combinations, and I believe they speak not only to the utility of U2 as a backbone and triple combinations but also highlight the potential benefits of our combination approach and our e-sell platform. It should provide us with a steady stream of commercial opportunities. To wrap up, I wanted to quickly review some upcoming goals and objectives for the remainder of 2021 and into 2022. First, we look forward to hearing from the FDA regarding our BLA submission for Lutoxin out to treat patients with relapsing forms of MS. We also will continue to work with the FDA on the YouTube BLA slash SNDDA for patients with chronic lymphocytic leukemia, which has a Badoofa target goal date of March 25th, 2022.

These are exciting combinations and I believe not only speak to the utility of Youtube as a backbone and triple combinations, but also highlight the potential benefits of our combination approach on our T cell platform that should provide us with a steady stream of commercial opportunities.

Wrapping up I want to quickly review some upcoming goals and objectives for the remainder 2021 and into 2022.

First we look forward to hearing from the FDA regarding our BLA submission for <unk>.

<unk> to treat patients with relapsing forms of M. S.

We also will continue to work with the FDA on the Youtube BLA Slash S. N V for patients with chronic lymphocytic leukemia, which has it produces target goal date of March 25th two.

<unk> thousand 22.

Michael S. Weiss: We plan to have an exciting Ash conference in December, so next month, and we're looking forward to having a live presence there, can be very exciting. As mentioned, in just a few minutes at 9 a.m., so that's 12 minutes from now, the abstract will go live.

We plan to have an exciting ash conference in December So next month and I'm looking forward to having a live presence there. So that's going to be very exciting as mentioned in just a few minutes at nine a M.

12 minutes from now the abstracts will go lives. We think this will be a great conference for us as were presenting data showcasing the potential value and utility of Youtube as a doublet combination therapy and also as a backbone of triple combinations.

Michael S. Weiss: I think this will be a great conference for us as well presenting data showcasing the potential value and utility of U2 as a double-acombination therapy and also as a backbone of triple combination. Of course, we will continue to focus on the commercialization of Eukonic and relapse in refractory marginal zone and follicular lymphoma and expand our commercial footprint in preparation for potential future launches, including U2 and CLL and eubaloxinab in relapsing forms of MS. We are continuing to drive enrollment into our Ultra V phase three trial, evaluating the triple combination of U2 plus banana class in both treatment naive and relashive factory CLL.

Of course, we will continue to focus on the commercialization of the economy.

Elapsed silver factory margins on in Follicular lymphoma, and expand our commercial footprint and preparation for potential future launches, including Youtube and Silao and Rituxan in relapsing forms of M. S.

We are continuing to drive enrollment into our ultra V phase III trial evaluating the triple combination of Youtube plus banana class in both treatment naive and relapsed refractory CLO.

Michael S. Weiss: And we plan to continue to advance our early pipeline candidates, including TG-171, our BTK inhibitor that we've been talking quite a bit about, but some earlier stage compounds as well, including TG-1801, our anti-CD-47 CD-19 bi-specific, and TG-151, our anti-PD-O-1 antibody. With that, I'm excited to turn the call over to our chief commercialization officer, Adam Walman, to share some Yep, thank you, Mike. Good morning, everybody.

And we plan to continue to advance our early pipeline candidates, including T. G 71, or PTK inhibitors that we've been talking quite a bit about but some earlier stage compounds as well, including T. G 18 O. One our anti CD 40, 17 to 19 by specific and T. G 15, one or anti PD lone antibody.

With that I'm excited to turn the call over to our Chief commercialization officer at a moment to share some highlights from our early commercialization efforts Adam.

Yes. Thank you Mike good morning, everyone.

I am pleased to provide an update on our core commercial activities for the third quarter as we continue to build on the Yukon, Nick launch and create a strong commercial platform capable of supporting multiple future launches.

Adam Waldman: I am pleased to provide an update on our core commercial activities for the third quarter as we continue to build on the Econic Launch and create a strong commercial platform capable of supporting multiple future lines. I'll start with what we are seeing in the overall market, present sales numbers, and then provide some qualitative detail on the line. Finally, I'll cover our priorities and activities to set the stage for upcoming potential launches in CLL and MS. Our commercialization teams continue to perform well in the third quarter.

I'll start with what we're seeing in the overall market presents sales numbers and then provide some qualitative detail on the launch.

Finally, I'll cover our priorities and activities to set the stage for upcoming potential launches.

CLO and MFS.

Our commercialization teams continue to perform well in the third quarter. However, COVID-19 continued to create challenges for patients and health care providers.

As we continue to understand the impacts we have looked at claims data.

Decatur, and reports and spoken with providers directly.

And they all confirm that patient visits.

And treatment initiations for patients with indolent lymphoma remain below pre pandemic levels.

Adam Waldman: However, COVID continues to create challenges for patients and health care providers. As we continue to understand the impact, we have looked at claims data, syndicated reports, and spoken with providers directly, and they all confirm that patient visits and treatment initiations for patients with end-stage lymphoma remained below pre-pandemic levels. As you're aware, indolentillinfulness patients tend to be elderly and at risk, causing providers to exercise greater caution in balancing potential patient exposure to COVID with the need for changes in treatment.

As youre aware in the lymphoma patients tend to be elderly and at risk, causing providers to exercise greater caution.

And balancing potential patient exposure to COVID-19 with the need for changes in treatment.

While we are confident in our strategy and execution, we continue to face challenging market conditions with the ongoing pandemic.

Despite these challenges we've seen some nice bright spots.

Overall demand for you kind of continue to grow with $2 million in net sales for the quarter, representing an increase of 32% from the last quarter.

Seeing growth in our base of prescribers as well as a number of repeat prescribers and accounts.

Further we are seeing growth that we're seeing growing use in the community with approximately 65% of our Q3, new patient starts in the community versus 35% of the academic centers.

Adam Waldman: While we are confident in our strategy and execution, we continue to face challenging market conditions with the ongoing pandemic. Despite these challenges, we've seen some nice bright spots. Overall demand for Yukon continues to grow, with $2 million in net sales for the quarter representing an increase of 32% from the last quarter.

That this is an encouraging trend as most of the community physicians that are prescribing you conic for Follicular and marginal zone are the same physicians that treat C O L.

And could prescribe Youtube for CLO if approved.

Our share of voice was robust during the quarter and based on third party research, we have achieved a leading share of voice across Follicular and marginal zone markets in both the community and academic centers, you conic awareness and familiarity among targeted treatment treaters remain high and prescribers continue to cite strong you conic performance across all.

Adam Waldman: We are seeing growth in our base of prescribers as well as a number of repeat prescribers in account. Further, we are seeing growing use in the community, with approximately 65% of our Q3 new patient starts in the community versus 35% in the academic centers. We think that this is an encouraging trend as most of the community physicians that are prescribing Econic for follicular and marginal zones are the same physicians that treat CLAO and could prescribe it to you too if CLL is approved.

Key attributes again, we believe high you conic awareness and foundational understanding of mechanics profile and our currently approved indications amongst our target prescribers.

Set a strong foundation for a potentially successful U two launched in CLO.

Moreover, we continue to hear positive feedback from customers about their experience with iconic T.

Adam Waldman: Our share of voice was robust during the quarter, and based on third-party research, we achieved a leading share of voice across polycular and marginal zone markets in both the community and academic centers. Eukonic awareness and familiarity among targeted treaters remain high, and prescribers continue to cite strong Eukonic performance across all key areas. Again, we believe high Eukonic Awareness and foundational understanding of Eukonics profile in our currently approved indication amongst our target prescribers set a strong foundation for a potentially successful U2 launch in CLO.

T G teams and our patient support services and impressively in third party syndicated research our field teams right at the top of the NHL category for quality of engagements and overall value.

As we have previously shared and shoot ensuring a positive first experience with iconic is he launched strategic imperatives. So hearing positive feedback is particularly gratifying.

Finally based on market research when prescribers understand the unique M away the differentiation on safety and Tolerability.

As well as compelling up as well as the compelling efficacy.

This does translate into a strong intent to prescribe.

We believe these are positive indicators give us confidence in our overall strategy and approach to the economy launch.

Adam Waldman: Moreover, we continue to hear positive feedback from customers about their experience with Econics, TG teams, and our patient support services, and impressively, in third-party syndicated research, our field teams are right at the top of the NHL category for quality of engagements and overall value. As we have previously shared, ensuring a positive first experience with Econics is a long-term strategic imperative, so hearing this positive feedback is particularly gratifying.

As mentioned during our last last call. We are seeing your conic demand from patients who are facing drug affordability issues. As a result through our patient P. D patient support program. We have provided your contact free to about 35% of patients.

We are proud to be able to support these patients in need by providing assistance when there are barriers to access.

To summarize we're very pleased with the iconic launch our goal since day. One of this launch was to start laying the foundation and building our commercial capabilities for future launches. This initial launch would be conic is allowing our teams to establish strong relationships with cancer centers and health care providers, while ensuring an initial positive experience with iconic and T. G.

Adam Waldman: Finally, based on market research, when prescribers understand the unique MOA, the differentiation in safety and tolerability, as well as compelling F, this does translate them into a strong intent to prescribe. We believe these are positive indicators and give us confidence in our overall strategy and approach to the Econic Law. As mentioned during our last call, we are seeing eukonic demand from patients who are facing drug affordability issues. As a result, through our TG patient support program, we have provided eukonic for free to about 35% of patients.

We estimate there was roughly an 80% to 85% overlap of our target prescriber base between non Hodgkin's lymphoma, and CLO reinforcing the importance of establishing our footprint with this launch we're excited to expand our commercial platform with the potential launch of our second drug <unk> as part of the Youtube doublet combination with <unk>.

Nick and CLO early next year in the U S market and believe our preparedness and our experience with you you conic launch will be invaluable to our success.

Now turning to the MF launch readiness as Mike as Mike mentioned now that we have submitted the BLA for botox in Nab in RMS. Our team has also accelerated our launch preparations we significantly strengthened our core capabilities in Q3, making critical hires in key home office and field base.

Adam Waldman: We are proud to be able to support these patients in need by providing assistance when there are barriers to access. To summarize, we're very pleased with the Econic launch. Our goal since day one of this launch was to start laying the foundation and building our commercial capabilities for future launches. This initial launch of Econic is allowing our teams to establish strong relationships with cancer centers and healthcare providers while ensuring initial positive experiences with Econic and TG. We estimate there is roughly an 80 to 85% overlap of our target prescriber base between non-Hodgkins lymphoma and CLL, reinforcing the importance of establishing our footprint with this launch.

Yes.

The team the team has deep and long standing ties to the Ms community.

Our team significantly ramped up their activities in Q3.

Actively engaging kols community neurologist payors.

And advocacy groups at conferences AD boards and one on one engagements our confidence continues to grow as the feedback and the toxin that profile has been very positive across the board and our belief is there is a very compelling commercial opportunity here in.

Adam Waldman: We are excited to expand our commercial platform with the potential launch of our second drug, Ubukymsamab, as part of the U2 double combination with Econic in CLL early next year in the U.S. market, and believe our preparedness and our experience with the Eukonic launch will be invaluable to our success. Now, turning to the MS launch readiness, as Mike mentioned, now that we have submitted the BLA for Ubukyxinab in RMS, our team has also accelerated our launch preparation. We significantly strengthened our core capabilities in Q3, making critical hires and key home office and field-based roles. The team has deep and longstanding ties to the Microsoft community.

In particular neurologists, new bill talks about efficacy and tolerability profile as impressive and highly competitive with existing CD twenties Uber.

Talks about shorter infusion and flexible pre medication or post monitoring requirements demonstrated and the ultimate one and two trials are also seen a significant advantages.

In summary, we continue to build and strengthen our core our core commercial capabilities and footprint as we ready the organization for multiple upcoming launches.

Continue to make nice progress with their iconic launch as utilization and experience at community and major cancer centers continues to grow.

And awareness of <unk> profile continues to expand we have also made significant progress preparing the organization to optimize the potential launch of Youtube and C. O L. Early next year and the potential launch of Google talks a mab and M. S. Late next year.

Adam Waldman: Our team significantly ramped up their activities in Q3, actively engaging KOLs, community neurologists, payers, and advocacy groups at conferences, ad boards, and one-on-one engagement. Our confidence continues to grow as the feedback on Ovalutuzumat profile has been very positive across the board, and our belief is that there is a very compelling commercial opportunity here. In particular, neurologists view Ubukympap's efficacy and tolerability profile as impressive and highly competitive with existing CD20s. Ubotoximab shorter infusion and flexible premedication and post-monitoring requirements demonstrated in the ultimate one and two trials are also seen as significant advantages.

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

Yeah.

Thank you Adam and thanks again to everyone for joining us this morning.

Earlier. This morning, we reported our detailed third quarter 2021 financial results, which can be viewed on the investors and media section of our corporate website.

For today's call I'll touch on a few highlights from the quarter, beginning with our cash position.

We ended the third quarter with approximately $381 million in cash cash equivalents and investment securities, which we believe will be sufficient to take us into 2023.

As Adam just noted we reported $2 million.

$2 million of your conic not net product revenue in the third quarter, representing a 32% increase over the second quarter of 2021 cumulatively.

Adam Waldman: In summary, we continue to build and strengthen our core commercial capabilities and footprint as we ready the organization for multiple upcoming lines. We continue to make nice progress with our iconic launch, as utilization and experience at community and major cancer centers continue to grow, and awareness of Econics continues to expand. We have also made significant progress preparing the organization to optimize the potential launch of U2 and CLL early next year and the potential launch of buboproximab and MS late. With that, I'll turn the call over to Sean. Thank you, Adam, and thanks again to everyone for joining us this morning.

Cumulatively in the first seven months of launch we have recognized approximately $4 3 million in net product revenue.

Our net loss for the third quarter of 2021, excluding noncash items was approximately 72 million.

In line with our expectations, which was an increase of $10 million quarter over quarter from Q2 of 'twenty one.

Sean A. Power: Earlier this morning, we reported our detailed third quarter 2021 financial results, which can be viewed on the investors and media section of our corporate website. For today's call, I'll touch on a few highlights from the quarter, beginning with our cash. We ended the third quarter with approximately $381 million in cash, cash equivalence, and investment securities, which we believe will be sufficient to take us into 2023. As Adam just noted, we reported $2 million of Eukonic net product revenue in the third quarter, representing a 32% increase over the second quarter of 2021.

Sean A. Power: Cumulatively, in the first seven months of launch, we have recognized approximately $4.3 million in net product revenue. Our net loss for the third quarter of 2021, excluding non-cash items, was approximately $72 million, in line with our expectations, which was an increase of 10 million quarter over quarter from Q2 of 21, where we saw a net loss excluding non-cash items of approximately $62 million. As compared to the second quarter of 2021, the increase was primarily driven by an uptick in research and development costs pertaining to our BLA filings for Ubutoximab in MS and an increase in CMC expenses incurred in Q3 of 21.

Thank you we will now be conducting a question and answer session.

I'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Press Star two if you would like to remove your question from the queue.

Participants using speaker equipment and may be necessary to pick up your handset before pressing the star kit one moment, please while we poll for questions.

Thank you. Our first question comes from Alicia Young with Cantor Fitzgerald. Please proceed with your question.

Sean A. Power: Comparing this quarter to Q3 of 2020, where we saw a net loss excluding non-cash items of approximately $59 million, the increase is primarily related to SG&A expenses associated with the launch of Econic and planning for the potential future launches of U2 in CLL and UBL-UKUKUXMMM. Our gap net loss for the third quarter of 2021, inclusive of non-cash items, was $85.6 million or 65 cents per share compared to a net loss of 87.2 million or 73 cents per share during the comparable quarter in 2020.

Hi, good morning, and thanks for taking our questions. This is neena on for Alethia.

We are wondering if if we can expect ultra V data by year end or should we expect that in 2022, and if I can have another line.

We're also wondering what are the challenges for Medicare funding for patients with marginal zone lymphoma and Follicular.

Follicular lymphoma, and how have you seen that dynamic play out and what can you do to minimize that impact. Thanks.

Operator: With that, I will now turn the call back over to the conference operator to begin the Q&A. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone key. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would 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.

Sure. Thanks for the question. So in terms of Ultra V. The expectation is that we will have data probably.

Middle of next year conferences so.

The <unk> E.

Maybe it legato.

<unk> focus on end of this year or ash, which.

Now the abstracts are live as of nine a M.

See that no ultra V, but we've been talking about that for a while that ultimately won't be till next year.

Operator: One moment, please, while we poll for questions. Thank you. Our first question comes from Alethea Young with Cantor Fitzgerald. Please proceed with your questions.

In terms of the Medicare.

Medicare funding for for patients with Marshalls honest Silicula I'll take a crack at them and if I Miss anything Adam can can chime in.

Unknown Speaker: Hi, good morning, and thanks for taking our questions. This is Nina and Aletia.

For the most part.

Unknown Speaker: We are wondering if we can expect ultra V data by year end, or should we expect that in 2022? And if I can have another one, what are the challenges for Medicare funding for patients with marginal zone lymphoma and follicular lymphoma? And how are you seeing that dynamic play out? And what can you do to minimize that impact?

These patients are on Medicare there.

I hate to use word elder relationships I'm approaching.

The average age of folks with Mars on Follicular, but it's an older patient population many of them are on Medicare.

They are most of them do have coverage.

The problem is the co pays associated with with Medicare.

Michael S. Weiss: Sure, thanks for the questions. So in terms of UltraV, the expectation is that we will have data probably by the middle of next year's conferences. Asco, Iha, maybe Blugano, that kind of focus, end of this year for Ash, which Now the abstracts are live as of 9 a.m. You'll see that no ultraVee, but we've been talking about that for a lot, that ultraVey wouldn't be until next year. In terms of Medicare funding for patients with marginal zone and follicular, I'll take a crack at them And if I miss anything, Adam can chime in.

So.

The only way to.

For companies to really help patients with co pays for that are on Medicare as to you to provide.

Support to charter will foundations that then in turn can help provide some of that support or provides the drug for free so.

Most of the things that most divisions have a have good coverage, except they are responsible for a portion of their drug costs and even though a small portion they cannot afford.

So that's why we see the free goods that we're giving away or for those patients who essentially can't afford their co pays they all have I must say all but the vast majority of them have have insurance.

Adam Waldman: For the most part, these patients are on Medicare. They're, I hate to use the word elderly since I think I'm approaching the average age of folks with marginal follicular. But it's an older patient population; many of them are on Medicare. They, most of them, do have coverage. The problem is the co-pays associated with Medicare. So the only way for companies to really help patients with co-pays that are on Medicare is to either provide support to charitable foundations that, in turn, can help provide some of that support or provide the drug for free.

Just they still can't afford the copays.

Yes.

Adam did I Miss anything that yeah sure yeah, Yeah, yeah. The only thing I would add is that the the reason we're experiencing issues. In this particular lymphoma is that there just is not availability of co pay foundation support.

We don't expect that we'll have the.

The same issues in C. L. L where there is there is more access to funding.

The funding is done by indication. So we're not seeing it is there's not a lot of it in lymphoma, but we do think of the the issue will be largely less it will be have a lesser impact on CLO because there is funding available there.

Adam Waldman: So most of, like I said, most of the patients have good coverage except they are responsible for a portion of their drug costs, and even though it's a small portion, they cannot afford. So that's why we see the free goods that we're giving away. are for those patients who essentially can't afford their co-pays. They all have, I don't say all, but the vast majority of them have insurance. It's just they still can't afford the co-payment. Adam, did I miss anything, man?

Yes.

Thanks, that's helpful.

Thank you.

Thank you. Our next question comes from Eric Joseph with Jpmorgan. Please proceed with your question.

Hi, good morning, Thanks for taking my questions.

A couple from us the first on your conic witches.

Whether you saw any sequential shifts in gross to net.

Versus second quarter, and perhaps how we should be thinking about that into year end.

And.

Whether at this stage as we look to expansion with Youtube for Cielo is there anything you might guide at this point in terms of how to think about gross net.

Adam Waldman: Yeah, sure. Yeah, yeah, yeah. The only thing I would add is that the reason we're experiencing issues in this particular lymphoma is that there just isn't enough availability of co-paced validation support. We don't expect that we'll have the same issues in CLL, where there is more access to funding. The funding is done by indication, so we're not seeing it. There's not a lot of it in lymph

Cielo setting.

And then perhaps as it relates to who will touch on that for RMS.

With sort of your.

Youre launch pre commercial preparations underway can you just talk a little bit about sort of the concentration of the prescriber account base there.

And.

I guess coming away from that.

What messages are.

<unk> strongly I think with the shipping community and what impact is.

Operator: But we do think the issue will be largely less, and it will have a smaller impact on CLL because there is funding available. Thanks, that's helpful. Thank you. Thank you. Our next question comes from Eric Joseph with J.P. Morgan. Please proceed with your question.

It was relative price.

Playing in your discussions with providers right now.

Sure so.

Adam why don't you if you could help me out on the.

On the gross to net question, Sri you tonic and for what we anticipate in CLO and then then we'll tag team on the on the RMS stuff.

Unknown Speaker: Good morning, thanks for taking the questions. A couple from

Unknown Speaker: A couple from us, the first on Eukonic, which is whether you saw any sequential shifts in gross to net versus the second quarter and perhaps how we should be thinking about that into year end. And whether, at this stage, as we look to, you know, expansion with YouTube or CLL, is there anything you might suggest at this point in terms of how to think about gross to net in the CLL setting?

Yeah, Eric Thanks for the question the gross to net is as you know.

Variable based on the type of patients that come into us and the site of care.

There will be a little variability and given the low patient volume that can be there can be swings from quarter to quarter.

Unknown Speaker: Okay, um, And then perhaps as it relates to Ubutucamad for RMS, can, with sort of your launch, pre-commercial preparations underway, can you just talk a little bit about sort of the concentration of the prescriber account based there? And I guess coming away from X terms, you know, what messages are responding strongly, I think, with the treatment community and what impact is as relevant price playing in your discussions with providers right now.

But it's largely in line with where we thought it was going to be and Theres not theres not major at this point there hasn't been major shifts in gross to net.

Yeah that was that was the first question what was the second question was around perhaps you want to take the second question.

Yeah, well just.

Too early still.

Alright, so CLO, it's too early to give any insight on gross to nets in CLO.

Michael S. Weiss: Sure, so Adam, why don't you, if you could, help me out on the gross tonight questions for Eutonic and for what we anticipate in CLL, and then we'll tag team on the RMS stuff. Yeah, Eric, thanks for the question. The gross on that is, as you know, variable based on the type of patients that come into us and the site of care. So there will be a little variability, and given the low patient volume, there can be swings from quarter to quarter.

Yes.

Got it Okay and then in terms of.

Lublin RMS to FERC question.

<unk>, our prescriber base.

I'll give an answer Adam correct am I wrong.

My understanding is that there's about 500 centers Eric.

That represented about 80%.

Of the total cover 80% of the patients. So it's a really highly concentrated.

Michael S. Weiss: But it's largely in line with where we thought it was going to be, and there aren't any major, at this point, there haven't been major shifts in gross to that. Um, that was the first question. What was the second question? Was around, did you want to take the second question? Yeah, we'll just finish up on. Yeah, so CLL, right.

In major centers here in the U S.

And.

In terms of.

Things, we heard at coming out of that comes I think particularly wanted to understand how price may impact.

The things that.

So both for <unk>, but as I mentioned in the prepared remarks, I really had a great opportunity to meet directly with with Kols. When I went to the live see MSC conference.

Adam Waldman: So, CLO, too early to give any insight on gross nuts and COL. Got it, okay. And then in terms of Ubley and RMS, a short question, concentration of prescriber base, I'll give an answer, Adam, correct from wrong. My understanding is that there are about 500 centers, Eric, that represent about 80% of the total number of patients covered, and 80% of the patients are female. So it's really highly concentrated in major centers here in the U.S., in terms of things we heard coming out of Xrums, and I think you particularly wanted to understand how price may impact.

I'd say again overall very very positive feedback people are very excited about the one hour infusion.

I think that's something that is definitely attractive, particularly.

For all the patients and for any any of the physicians that have infusion centers or associated with infusion centers that went out infusion is a is really something that's quite attractive.

They really like the mechanism and a lot of people were digging in on the global engineering aspect of the types of Mab.

Adam Waldman: The things that, so both from Xterms, but as I mentioned, the prepared remarks, I really had a great opportunity to meet directly with KOLs when I went to the live CMSC conference. I'd say, again, overall, very, very positive feedback. People are very excited about the one-hour fusion. I think that's something that is definitely attractive, particularly for all the patients and for any of the physicians that have infusion centers or are associated with infusion centers. That one-hour infusion is really something that's quite attractive. They really like the mechanism.

The different epitope binding sites.

Definitely you know people are understanding that this is a differentiated CD 20.

And that was generating a bit of excitement.

And then circling back to price.

You know what we hear now consistently.

Is that access.

Is it is probably more important than price, assuming something like use price to buy access.

Price matters.

But really it's a function of when they have an option for patients they want to know that they can get the patient on the drug.

Michael S. Weiss: You know, a lot of people were digging into the glycoengineering aspect of ovalytocinab, the different epitope binding sites. Definitely, people were understanding that this is a differentiated CD20, and that was generating a bit of excitement. And then circling back to price, you know, what we hear now consistently is that access is probably more important than price. Assuming we can use price to buy access, price matters, but really, it's a function of, you know, when they have an option for patients, they want to know that they can get the patient on the drug that they choose, and they want to know how to get them on the drug quickly.

That they choose and they wanted us to get them on the drug quickly they.

They do say that yeah. They do sometimes have challenges with OCA vis and getting patients on in a timely fashion.

So there's definitely room for improvement there and our payer team is out there hustling every day to try to identify ways in which we can cut through as much of the red tape as possible and we've said this multiple times if price gets us there we will use price to to do what we can to create the best access.

For protection I have enormous.

Adam any any additional thoughts.

No Mike I think you've got it.

Okay.

Michael S. Weiss: They do say that, you know, they do sometimes have challenges with Okervis and getting patients on in a timely fashion. So there's definitely room for improvement there, and, you know, our payer team is out there hustling every day to try to identify ways in which we can cut through as much of the red tape as possible. And we've said this multiple times.

Okay, great. Thanks for taking my questions.

Yep that's great.

Thank you. Our next question is from Ed White with H C. Wainwright. Please proceed with your question.

Good morning.

No good question start off.

For Adam.

Can you comment on the.

Percentage of live engagements.

With the prescribers right now and are you seeing any any changes as we work our way through the pandemic and.

Michael S. Weiss: If Price gets us there, we'll use Price to do what we can to create the best possible bitusine for a bitusine. Adam, any additional thoughts? No, Mike, I think you got it.

How is it going with the education of the providers per your connex or other.

Or do they understand the differentiation and maybe if you can tell us some of the challenges that you might be seen.

Unknown Speaker: Thank you. Great, thanks for taking the questions. Yep, that's great.

Sure Ed.

Operator: Thank you. Our next question is from Ed White with H. C. Wainwright. Please proceed with your, Good morning. The question will start off with Adam.

A great question are we you know we we.

We're certainly seeing some increases in live engagements towards.

Unknown Speaker: Can you comment on the, you know, percentage of live engagements with prescribers right now, and are you seeing any changes as we work our way through the pandemic? How is it going with the education of providers for Eukonics? Are there, Do they understand the differentiation, and maybe if you could tell us some of the challenges that you might face? Sure, Ed, a great question. We were certainly seeing some increases in live engagements towards, you know, the early summer months.

The early summer months.

Delta picked up that definitely declined as cancer centers went back to.

Covid restriction policies that said made it made it more difficult to get a lot of engagements.

We're hopeful now that the the Delta variant has gone down we are starting to see pickup now back into the fourth quarter, which is which is great. We do believe live engagements are a much more effective way of communicating.

Unknown Speaker: As Delta picked up, that definitely declined as cancer centers went back to COVID restriction policies, that made it more difficult to get to live engagements. We're hopeful now that the Delta variant has gone down. We're starting to see pickup now back into the fourth quarter, which is, which is great.

We've said before that there is a bit of fatigue with a behemoth community with with the zoom calls that have been going on although we still do it. We think live engagement is just is this a more effective way of educating.

Adam Waldman: We do believe live engagements are a much more effective way of communicating. We've said before that there is a bit of fatigue within the Hemok community with the Zoom calls that have been going on. Although we still do it, we think live engagement is just a more effective way of teaching.

What we've done I mean, the challenges that you asked about yeah. This is a challenging environment no question.

What we've done in response as we've increased our digital and non personal afterwards.

We've had to be innovative in the way that we've done our educational programs and it is very clear to us that.

When we do put the profile and we do have the opportunity to get the profile in front of physicians.

Adam Waldman: You know, what we've done, I mean, the challenges that you ask about, yeah, this is a challenging environment, no question. But what we've done in response is we've increased our digital and non-personal efforts. We've had to be innovative in the way that we've done our educational programs, and it is very clear to us that when we do put the profile, and we do have the opportunity to get the profile in front of physicians, the feedback is largely very, very positive. It's just a matter of being able to do it and do it on a frequent basis, right?

But the feedback is largely very very positive.

It's just a matter of being able to do it and do it on a frequent basis right getting in and sometimes it takes especially with a new product. It does take multiple visit sometimes multiple interactions for people to appreciate the full profile and to identify patients. So that is a continuing challenge is we can get in but then the frequency.

Of which we get repeat visits.

It's been difficult.

Like I said, we've developed innovative educational programs and speaker programs different types of modalities to do that and we're continuing to adjust that as the the.

Adam Waldman: Getting in, sometimes it takes, especially with a new product, it does take multiple visits, sometimes multiple interactions for people to appreciate the full profile and identify patients. So that is a continuing challenge; we can get in, but then the frequency of which we get repeat visits has been difficult. Like I said, we've developed innovative educational programs and speaker programs, different types of modalities to do that, and we're continuing to adjust as the COVID environment changes. The dynamics of that are continuing to change really from month to month.

The Covid environment is continuing to dynamics from that are continuing to.

To change from from really from month to month.

We've also increased our investments in data to try to identify patients. So that is another area that.

We feel like if we can identify patients and know where to go we can do some some interesting things around.

Better targeting and we can use that as a as an access to will be get into prescribers that have that have patients on the information that is very relevant to them.

Unknown Speaker: We've also increased our investments in data to try to identify patients. So that is another area that, you know, we feel like if we can identify patients and know where to go, we can do some interesting things around, you know, better targeting, and we can use that as an access tool to get into prescribers that have patients, and the information is very relevant to them. Great, thanks Adam. That's, yep. Now a question on European strategy.

So.

Yes.

Great. Thanks for that that's it now.

No.

Now a question on the European strategy, you had mentioned last quarter.

That you might target.

Before the hematology.

Can you just give us an update maybe on your European strategy and also your thoughts on perhaps partnering.

Yes, I'll jump in there and.

Michael S. Weiss: You had mentioned last quarter that you might target MS before hematology. Can you just give us an update on your European strategy and also, you know, your thoughts on perhaps partners? Yes, so I'll jump in there, Ed.

So.

We haven't made any final decisions, but we are definitely leaning significantly towards bringing EMS forward first in Europe.

And in terms of partnering you know again I think we haven't made any final decisions were certainly leaning toward a go it alone strategy, but we're certainly keeping our options open.

Michael S. Weiss: So we haven't made any final decisions, but we are definitely leaning significantly toward bringing the MS forward first in Europe. And in terms of partnering, you know, again, I think we haven't made any final decisions. We're certainly leaning toward a go-to-loan strategy, but we're certainly keeping our options open.

Thanks, Mike and then last question maybe for Sean just on R&D. You had mentioned the increase was due to the BLA submission and.

Increased manufacturing costs.

Unknown Speaker: Thanks, Mike. And last question, maybe for Sean, just on R&D, you had mentioned the increase was due to the BLA submission and increased manufacturing costs. Should we be thinking of these?

Should we be thinking of these obviously BLA submission as onetime in nature, but.

Perhaps you can give us your thoughts on what's sort of the underlying run rate for R&D and how we should be thinking of it.

Sean A. Power: Obviously, the BLA submission is one-time in nature, but, Perhaps you can give us your thoughts on what's the underlying run rate for R&D and how we should be thinking of it, you know, directionally for the fourth quarter and, perhaps, if you're willing, for 2022. Thank you.

Directionally.

For the fourth quarter, and perhaps if youre willing for 2022. Thanks.

Sure. Thanks for the question I think ahead of.

Potential approval for Botox and I believe we may see some some lumpiness in or.

Sean A. Power: Thanks for the question. I think ahead of potential approval for bublotoxymab, we may see some lumpiness or some bumpiness in R&D as the CNC costs will run through the P&L ahead of being able to go on the balance sheet of inventory. Directionally, for 22, I would say, you know, if you average the R&D expenditure over the course of 21, it's probably going to be pretty high, with maybe a little bit of an uptick towards the latter half of 22.

And bumping is in R&D.

As the CMC costs will run through the P&L ahead of being able to go on balance sheet as inventory.

Directionally for 'twenty two.

I would say if you average.

The R&D for over the course of 'twenty one.

It's probably going to be.

Pretty flat with maybe a little bit of an uptick towards the latter half of 'twenty two.

Yeah.

Unknown Speaker: Okay, great. Thanks for taking my questions. Thanks, Ed.

Okay, great. Thanks for taking my questions.

Thanks, Ed.

Thank you. Our next question is Gonna, Chris Howerton with Jefferies. Please proceed with your question.

Operator: Thank you. Our next question is from Chris Howardton with Jeffrey. Please proceed with your question. Great, thank you so much for taking the questions.

Great. Thank you so much for taking the questions.

Unknown Speaker: I guess the two from me first would be just, I guess, related to the CM&C. You know, with respect to kind of heading into the Padoofa dates, what is the preparedness of CMNC and supply, particularly for ublotoximab as it relates to both the CLL and MS application. As a follow-up to that, is there additional supply that will be required to serve the MS market, one and if both indications are approved? And then the third question, if I may, for Adam, would be, you know, as you're kind of looking at the new patient ads from the community setting, what would you say is the impact of the site experience during the clinical trials that you ran? Yeah, so Chris, I'll jump in on the CMC stuff.

Yes, the two for me first would be just.

Related to the C M C.

You know with respect to kind of heading into the Paducah dates are what is the preparedness of CMC and supply, particularly for <unk> as it relates to both the CLO and the M S applications.

As a follow on to that is there additional supply that will be required to serve the EMS market when and if both indications are approved.

And then the third question if I may for Adam would be you know as you're kind of looking at the new patient adds from the community setting.

What would you say is the impact of the site experience during the clinical trials that you ran.

<unk>.

Yeah, So Chris I'll jump in on the AR on the CMC stuff. Yeah. We are we're feeling very good about our CMC readiness and supply we've got a long term supply agreement with the number one antibody manufacturer in the world.

Michael S. Weiss: Yeah, we are feeling very good about our CMC readiness and supply. We've got a long-term supply agreement with the number one antibody manufacturer in the world. And so we're feeling quite good about where we are with that. In terms of additional supply for MS, on a volume basis, MS is we don't use a lot of material.

And so we're feeling quite good about where we are with that but with that.

In terms of additional supply for EMS.

On a volume basis Msas.

We don't use a lot of material for M. S. So it's all ships and then the overall.

Michael S. Weiss: material for MS. So it's all subsumed in the overall CMC agreement we have with our supplier. And yeah, we feel very comfortable again that we have plenty of supply through that relationship for both the oncology and CLL and NSW. Adam, did you follow the second question completely? I personally did not.

CMC agreement, we have with our supplier.

And yeah, we feel very comfortable again that we have plenty of supply through that relationship.

For both the the oncology and CLO and a N S launches.

Adam did you follow the second question completely because I personally did not I did.

Adam Waldman: Yep, I got it. I did it. I did. Yep, I got it. Go for it!

Yes, I got it so far.

Adam Waldman: So, Chris, in the community and the new patient ads, yeah, we're seeing, yeah, the majority are with sites that have had experience in our clinical trials so that they were part of the trial, the development of the drug in the U.S., so I do think it is, you know, we've said it before, I think that that helped. And we are seeing that the use in the community is not, you know, exclusively in those sites, but we do see a large percentage of the use coming from sites that were involved in clinical trials previously. Okay, well, thanks a lot for taking the questions, and I appreciate it. Thanks, Chris.

So Christian in the community and the.

The new patient adds yes, we're seeing the.

The majority is is with sites that have had experience in our clinical trials.

So that they were they were part of the trial.

The development of a drug in the U S. So I do think it is we've said it before I think that that helped them and we are seeing that they use in the community is is it's not exclusively in those sites, but we do see a large percentage of the use coming from sites that were in.

Vault in the clinical trials previously.

Okay, well, thanks, a lot for taking my questions and I appreciate it.

Thanks, Chris.

Operator: Thank you. Our next question comes from Liyanka Mammatomi, with B. Riley. Please proceed with your question. Good morning, team.

Thank you. Our next question comes from Liang <unk> with B Riley. Please proceed with your question.

Good morning, and thanks for taking our question. So so two quick ones for item on commercial and then I have a ash abstract since the abstracts are out now I guess you can talk about it so before that.

Unknown Speaker: Thanks for taking our question. So, two quick ones for Adam on the commercial, and then I have an abstract. Since the abstracts are out now, I guess you can talk about them. So, before that, Adam, Adam, on the, you know, where we are with the pandemic, sort of going forward question, you know, obviously there are bright spots, people getting vaccinated, especially the high-risk elderly, getting the booster. Is there like a pent-up demand dynamic that we should be aware of for any of the upcoming quarters from Relisip?

Adam on the on where we are with the pandemic going forward question. You know obviously there are bright spots you know people getting vaccinated, especially the high risk elderly getting the booster.

Is there like a pent up demand dynamic that that we should be aware of or any of the upcoming quarters for from Burleson and and then on M. S. Readiness I was just curious this.

Adam Waldman: And then on MS readiness, I was just curious about this Alzheimer's drug dynamic in neurology clinics and even, you know, as you prepare, I know, as you prepare, I know it's early, but you are preparing to engage with CMS in some way. How much is that playing a role in your, you know, payer and access conversations within the team? Yeah, sure. Yeah, no, I wouldn't, you know, on the pandemic, you know, this stuff is just so difficult to predict, you know, how this is going to go. I wouldn't expect there to be a pent-up demand.

Alzheimer's drug dynamic in neurology clinics and even.

You know as you prepared I know, it's early but you you are preparing to engage with CMS and in some way how long how much is that playing a role in your better access conversations within the team.

Yeah sure Yeah, no I wouldn't you know on the on the pandemic you know this stuff is just so so difficult to predict.

You know how this is going to go I wouldn't expect there'll be a pent up demand I think that hopefully as as COVID-19.

Adam Waldman: I think that hopefully, as COVID starts to go down, we will see, you know, increased patient flow. And, you know, but I don't think there's going to be a big patient, you know, pent-up demand. Um, so, you know, I think it'll slowly trickle in, and I think that'll be generally positive. I think as the COVID situation increases, that's generally positive. And, you know, we're optimistic about the future.

Starts to go go down we will see increased <unk>.

Hello.

And you know.

But I don't think theres going to be a big patient.

Pent up demand.

Hum.

So you know I think it will slowly trickle in and I think that'll be a pod generally a positive I think as the as the Covid situation increases that's generally a positive.

And you know we're optimistic for the future.

Adam Waldman: Um, as far as the second question goes, my act on the Alzheimer's drug and, in that, those dynamics on infusions in, in, in MS, um, you know, the use of the drug has been light, as far as I can tell. I don't think at this point that we think the Alzheimer launch will affect the access to lebutyxinab and MS. You know, it's something that we'll obviously watch, and we understand infusion dynamics to be important.

As far as the second question goes my neck on the Alzheimer's drug and that those dynamics on infusions and then Ah NMS.

The use is the.

They.

The use of the drug has been light as far as I can I can tell.

I don't think at this point, we think the Alzheimer launch will affect the access of or protection of an M. S.

It's something that we'll obviously watch them and we understand infusion dynamics to be important.

Adam Waldman: Just as a reminder, the majority of MS patients, you know, have commercial insurance in the younger patient population. So maybe slightly different from a reimbursement dynamics than the Alzheimer's situation, although I'm not as familiar with Alzheimer's. I just feel like it's a more older population and potentially a more Medicare population. So I think there'll be a bit different dynamics there from just an insurance mix perspective. Hopefully that answers your question.

Just as a reminder, the majority of en masse patients.

Have commercial insurance or the younger patient population. So so maybe it might be slightly different from a reimbursement dynamics than the Alzheimer's situation, although I'm not as familiar with Alzheimer's or just I just feel like it's a that's a more older population of potentially a more Medicare population.

So I think there'll be a bit different dynamics there from a just an assurance mix perspective.

Hopefully that answers your question yeah.

Unknown Speaker: Yeah, and the capacity of neurology clinics may be helpful there too. So on the Ash abstract question, there are lots out there, Mike, if you can just maybe distill down on where we should focus, and maybe the specific question I had was around your U2, I've written an abstract. Can you just remind me, with your BTCA, YouTube, what we know about the median treatment duration, and where we stand with the current discontinuation rate there with the ongoing study? Yeah, so just starting from there, I'd have to double check, but the discontinuation rate through the AAs is very, very low with TG-1701. Very, very well.

Yeah, and and and.

The capacity of neurology clinics, maybe helpful. There too so on the ice.

Abstract question lots out there Mike.

If you can just maybe just drill down on where we should focus on and maybe the specific question I had was it all together you do a ibrutinib abstract.

Can you just remind me what your BD Gaye you do what do we know about the median treatment duration in and where do we stand with it got into schedule nation right. There's the odd links.

Yeah, So just starting from there.

To double check, but the discontinuation rate due to Asus.

It's very very low without with T. G 17 O one.

Very very low.

Michael S. Weiss: So I, I don't have the percentage in front of me, but I know that this continuation was very well, in terms of overall abstracts and things to focus on and the YouTube plus, BTK, abstract that you specifically highlighted. So, you know, it's an interesting case, Ash, for us. We've got two presentations that came out of our Unity NHL trial. We have some data from U2 in marginal zone lymphoma, which I think is looking quite good. And we have some additional data that we haven't looked at in a while. We'll be presenting on U2 in diffuse large B cell, which is kind of intriguing.

So I I don't have the percentage in front of me, but I know the discontinuation is very low.

In terms of overall ash abstracts, and things to focus on and the Youtube plus.

T K.

Abstract.

Specifically Ah.

Highlighted so you know it's it's a it's an interesting ash for US we've got two presentations that come out of our unity NHL trial.

Have some some data from you too in marginal zone lymphoma, which I think is looking quite good and.

And we had some additional data that we haven't looked at it in a while I'm presenting we'll be presenting on Youtube in diffuse large b cell.

Which is now kind of intriguing and some interesting information American food presentation, its coming together nicely.

Michael S. Weiss: There's some interesting information there. I think the presentation is coming together nicely. So that's the UNI-NHL, some interesting data coming out there. We have some nice UNI-CL cuts of the data. Again, these are more tertiary and post hoc analysis.

So that's the unity NHL some some someone shouldn't come into there we have some nice zumiez.

C O L cuts of the data again or is there more tertiary and post hoc analysis, one that I'm, obviously quite keen on as you know we've always said that there's this population of patients.

Michael S. Weiss: One that I'm quite keen on is, you know, we've always said that there is this population of patients who may be poor candidates for BTK inhibitors based on comorbidities or on con meds, or con-commit medications that they need to be on. So we went back through our phase three database to look at, you know, what percentage of the patients have comorbidities that could make them poor candidates for BTK and others that are on medications that are contraindications, or contraindicated with BTKs.

Who maybe poor candidates for Teekay inhibitors based on Comorbidities or on a and con meds concomitant medications that they need to be on.

So we went back through our.

Phase III database to look at you know what percentage of the patients have comorbidities that could.

Make them poor candidates from PTK and others that are on medications that are contra indication contra indicated with each case.

Michael S. Weiss: It's a much larger portion than we had anticipated when we started the effort. So I think that is going to be quite interesting for folks and really highlight that there is a need for novel therapies and you two can really fit nicely into certain practice settings that we've been discussing for a while now. In terms of BTK, obviously, we are quite enamored with our own 1701; we think it's a very, very good BTK inhibitor.

It's a much larger portion than than we had anticipated when we started the effort.

So I think that theres going to be a quite interesting for folks and really can just highlights that there is a need for for novel therapies in <unk>.

You too can you kind of really fit nicely into a certain practice settings that we've been discussing for a while now.

In terms of you know P.

E T. K honestly, we are quite enamored with their own 17 are one we think it's very very good PTK inhibitor, we like them they like it alone and in combination with Youtube, but.

Michael S. Weiss: We like it alone, and we like it in combination with you too. But in addition, I would say one of the cooler, to me, cooler trial designs that we have going and plan to expand is U2 plus abrutinib, one that will be presented. You know, I think that was the brainchild of Dr. Anthony Medo. I just think it's one of the smarter thoughts on how to potentially change the game and how patients are managed even on BTK inhibitors.

But.

In addition, I would say one of the cooler to me cooler trial designs that we have.

Going on and plan to expand.

Is that the Youtube plus ibrutinib.

One that will be presented.

You know I think you.

Yeah that was a that was the brainchild of doctor. After they made out I just think it's one of the smarter thoughts on how to potentially change the game and how patients are managed even on beach K inhibitors by using Youtube to try to essentially create prolonged drug holidays off of off of the Takeda therapies again.

Michael S. Weiss: by using U2 to try to essentially create prolonged drug holidays off of BTK therapies. Again, we're dealing with better tolerated BTKs like 1701 and others that are now approved or hopefully will be approved soon. But regardless, any time you're on a drug, you run the risk of side effects.

[laughter], where we're dealing with a better tolerated beat Teekay is like.

17 O on them and others.

That are now approved or or hopefully will be a person and but but regardless anytime you're on a drug you run the risk of a side effect.

Michael S. Weiss: This is a study in which we see if we can take patients who are on P2K inhibitors. They may be having a good outcome, but they're certainly not able to get off that treatment, so they're on it. Some of them may be experiencing some side effects, but using U2 to get to a deeper response, looking at undetectable minimal residual disease, and then getting patients off all therapy and then following them to see how long they could stay off therapy without having to get back on some treatment. So again, like I said, I think it's one of the cooler designs.

This is a study in which we see if we can take patients who are on PTK inhibitors.

They may be having a good outcome, but they're certainly not able to get off that treatment. So they're on it some of them may be experiencing.

Some side effects and using Youtube to get you a deeper response.

Looking at undetectable minimal residual disease, and then getting patients of all therapy and then following on to see how long they could step therapy without having to get back on some treatment.

So again like I said I think it's one of the Covid designs I think it's a it's a really neat application of using Youtube to help patients get to a better outcome and we'll see what that day.

Michael S. Weiss: I think it's a really neat application of using U2 to help patients get to a better outcome. And we'll see what that, the, the data as it's presented look like, but I'm quite encouraged by that one as well. Thank you, Mike.

The data as it is presented looked like but I'm quite encouraged by that one as well.

Thank you Mike look forward to additional detail does do you guys think about the design.

Michael S. Weiss: Look forward to additional details as you guys think about the design. Appreciate you taking the time to ask a question. Thank you.

You said, you're taking my questions.

Thank you.

Thank you. Our next question is from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Operator: Our next question is for Matt Kaplan with Ladenberg-Stellman. Please proceed with your questions. Thank you. Good morning, Mike and team.

Thank you good morning, Mike and team.

Unknown Speaker: I wanted to, I guess, first, maybe a question for Adam. Can you talk a little bit about the current status and size of the commercial organization and how you expect it, I guess, to evolve over the next 12 months as you head into the launch in CLL for U2 in March and April and then into, I guess, the MS markets in the second half, third, fourth quarter of next year.

Wanted to I guess first maybe a question for Adam can you talk a little bit about the current status and the size of the commercial organization and how you expect it.

Yes to evolve over the next 12 months as you.

You know heading for a launch.

And C L L for you too.

In March April and then into I guess, the EMS market.

And the second half a third or fourth quarter.

Adam Waldman: Sure, Matt, thanks. So we have about a 70-person field footprint right now on the oncology side. And, you know, I think we've made some opportunistic expansions here for CLL that, you know, in small numbers that help reinforce the team in areas that we thought we needed some reinforcements. And some, you know, we're looking for ways to increase our ability to access certain accounts.

Next year.

Sure Matt Thanks.

So.

We we have about a <unk>.

70 person feel.

<unk> footprint right now on the oncology side.

And I think we've made some opportunistic expansions here for CLO debt.

In in small numbers that help reinforce the team in areas that we we thought we needed some reinforcements.

So we're looking for ways to increase our ability to access certain accounts.

Adam Waldman: But largely, the oncology footprint is in place for what we need for CLL. We feel pretty good about it. And as we said in the prepared remarks, the experience that we're getting from the Eukonic launch is going to help us as we go into TLO. On the MS front, as Mike had answered earlier, this is a more concentrated market than perhaps people think. 550, you know, centers of excellence that are seeing 80% of the patients.

But largely the oncology footprint is is is in place for what we need for CLO, we feel pretty good about it.

As a as we said in the prepared remarks, the experience that we're getting the you know from from your conic launches going to help us as we go into the CLO.

On the MS front as Mike had answered earlier. This is a more concentrated market and then than perhaps people think.

550.

Centers of excellence that are seeing 80% of the patients.

Adam Waldman: You know, it sets up for, you know, a field footprint that is a reasonable size. I think most other competitors are in the 80 range on reps, 80 to 70 or so, 80 to 100 on rep size.

It sets up for <unk>.

<unk>.

Like field footprint that is a reasonable or size I think most other you know.

Competitors are in the 80 range on reps eating disorder, 80, or so 80 to 100.

On the Rep side.

Adam Waldman: And, you know, we're evaluating right now what that will look like for us. But, you know, it, you know, I think you can use that as a reference for how you might think about the size of our team going forward. Okay, that's very helpful, thank you.

And we're evaluating right now what that will look like for us.

But it I think you can use that as a reference for for how you might think about the size of our team going forward.

Okay. That's very helpful. Thank you and then I.

Secondly in terms of.

Unknown Speaker: And then, I guess, secondly, in terms of maybe more for Adam, too, and in your research and, I guess, your outreach pre-approval, how is Obotoxymab, you know, its differentiated profile with respect to efficacy and potentially with respect to infusion-related reactions and infusion times, how has that been responding with potential prescribers? What are their hot buttons, I guess, that you're hearing back? You want to go ahead, Adam? I think Matt wanted you to answer that one, although I could answer it, Matt, but I'll let Adam. Why don't you, why don't you start, Mike? Because you were down there, you were at the ad board last week, so why don't you start? I'll fill you in.

Maybe more for Adam too and in your research and I guess your outreach a pre approval how is Oh botox ma'am, you have a differentiated profile with respect to efficacy and and and.

And potentially with respect to infusion related reactions and infusion times, how has that been resonating with potential prescribers and what's what's what are their their hot buttons, I guess that you're hearing back.

Do you want to go ahead, and I think I think that once that you'd asked that one although I could answer it.

It was one.

Why don't you start and Mike you were you were down there you were you were.

Europe, you had board last week because.

Once you start all for me.

Michael S. Weiss: You're being super polite. You were there as well, but yeah, look, Matt, it was a, it would have been, For me, personally, it was great. I've been in and out of direct interactions with the MS folks, and it was really nice for me to get back in it live about two weeks ago in Orlando. Yeah, I think, you know, people are very impressed with the activity level and the compound. Again, you know, what I've been saying for a long time, some folks are completely convinced it's a better activity profile, and others are, you know, are bucketing at, you know, 20s all work really well. So I think you'll get a mixed reaction. No one thinks it's inferior, so that's good.

You're being Super polite you were there as well, but yeah. He looked at Matt there was a.

For me personally it was great I mean, I've I've been in and out of the direct interactions with the <unk>.

MS folks in and it was really nice for me to get back in it lives.

About two weeks ago in Orlando.

Yeah, I think you know people are very impressed with the activity level. The compound again, what I've been saying for a long time. Some some folks are completely convinced it's it's a it's a better activity profile and others are you know our buckets CD Twenty's all work really well, so I think you'll get a mixed.

Action.

No no one thinks it's inferior stuff that's good so it's ever I think most people would say on par or better.

Michael S. Weiss: So it's everything most people would say on par or better from an efficacy standpoint. You know, I think overall people are excited about the infusion times and the associated infusion-related reactions. But, you know, I think when you talk to folks, Okra definitely has its issues on the infusion side that people are pretty aware of and somewhat focused on.

From an efficacy standpoint.

Yeah, I think overall people are excited about the the infusion times and the associated infusion related reactions.

You know I think when you talk to folks okra.

It definitely has its issues on the infusion side that people are pretty aware of and somewhat vocal about so I think they looked at the IRI data, we're actually quite comforted by it. So I think all all systems are go from what from what I could tell again I think key attributes you know the activity profile.

Michael S. Weiss: So I think they looked at the IRR data and were actually quite comforted by it. So I think all systems are go from what I can tell. Again, key attributes, you know, the activity profile, safety, everything's got to be online, and the better, and I think that's where people perceive it.

Safety Everything's gotta be online and two to the better and I think that's where people perceive it.

Michael S. Weiss: And then, you know, the hour fusion is extremely attractive, but the big one, as I mentioned earlier, is all about access, right? So to the extent we can drive great access, you know, ideally through price, then we'll be in a great position. We'll be in a great position regardless, but it is an access game. People want to just make sure they can pick the drug that they want at the time they want to give it, and they don't want to have too many hassles, which is understandable when you think about 500 centers treating 80% of the patients. The throughput volume is really tremendous.

And then you know the hour infusion is extremely attractive and that's the big one as I mentioned earlier is all about access right. So to extent, we can drive a great great access.

Ideally through price then we'll be in a great position, we're being I mean.

In a great position, regardless, but but it is a it is an access games people want to just make sure they can.

Pick the drug that they want at the time, they want to give it and they don't want to have too many hassles, which is understandable when you think about 500.

Centers treating 80% of the patients.

The throughput volume is is really tremendous.

Michael S. Weiss: Great, thanks, thanks, Mike. I guess one last question: Mike, you mentioned in your kind of walk through the ash abstract highlights that U2 and DLBCL are some new data there being intriguing. Any thoughts on potential next steps with the development of DLBCL?

Alright, Thanks, Mike I guess, one last question, Mike you mentioned in your.

Kind of walk through ash abstract highlights.

You too in D L P Seattle or some new data there being intriguing.

Any thoughts on potential next steps with with development for D. L. P. C L.

Michael S. Weiss: You know, we're still just putting it all together in terms of the data. But yeah, I think it's something we should look into. Step one is to get U2 approved for CLL, and then step two is we can look to a supplemental filing and see, you know, fully evaluating which data sets could be part of that supplemental filing. We think U2 in the marginal zone is certainly a potential candidate for inclusion in that kind of a filing as well.

Yeah, we're we're still just putting that altogether in terms of the data, but yeah. I think it's something we're going to look into.

And step one is let's get you to approve for C. O L. And then step two is we can look to a a supplemental filing.

And seeing you know fully evaluating which data sets can be part of that supplemental filing.

We think Youtube marginal zone is certainly a potential candidates for inclusion in all kind of a filing as well.

Michael S. Weiss: And yeah, we'll take a hard look at the diffuse LRGB cell and see if we can include that in a filing. Well, thanks for taking the questions, and congratulations and all the best. Thanks, Matt. Questions will be taken in the order they are received.

Yeah, we'll take a hard look at the diffuse large b cell.

If we can include that in our filings too.

Great.

Thanks for taking my questions and congrats on all the partners.

Thanks, Matt.

Thank you there are no further questions at this time I would like to turn the floor back over to Mike Weiss for any closing comments.

Michael S. Weiss: Likewise for any closing comments.

Operator: Well, since the hour is late, markets are already open, I'll keep this quite brief and just thank everyone for joining us this morning and continuing to support us. Have a great day. Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Ah well since the hours late markets reopen keep this quite brief and just thank everyone for joining us this morning, and continuing to support us.

Have a great day. Thank you.

This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.

Yeah.

Okay.

Yeah.

[music].