Q4 2020 TG Therapeutics Inc Earnings Call

[music].

[music].

Greetings and welcome to the TG Therapeutics fourth quarter and year end 2020 conference call.

Operator: Greetings and welcome to the TG Therapeutics 4th Quarter and Year End 2020 Conference Call. At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.

Operator: A question-and-answer session will follow the formal presentation. In order to ask a question, please dial in and press star one on your telephone keypad. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

In order to ask a question please dial in and Flex and press Star one on your telephone keypad.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.

Operator: As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. Please go ahead.

I would now like to turn the conference over to your host Jenna Bosco Senior Vice President of corporate Communications. Please go ahead.

Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the fourth quarter and year end 2000, Twenty's financial results and provide a business update or Sean power, Our Chief Financial Officer, Michael Weiss, Our executive Chairman and Chief Executive Officer, and Adam Waldman, our chief commercialization.

Jenna Bosco: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and year-end 2020 financial results and provide a business update are Sean Power, our Chief Financial Officer, Michael Weiss, our Executive Chairman and Chief Executive Officer, and Adam Waldman, our Chief Commercialization, Following our Safe Harbor Statement, Sean Power will provide a brief overview of our financial results and then turn the call over to Michael Weiss, who will provide an overview of our recent corporate developments, as well as an update on our current pivotal programs and key goals for 2021.

Asian Officer.

Following our safe Harbor statement, Sean power will provide a brief overview of our financial results and then turn the call over to Michael Weiss, who will provide an overview of our recent corporate developments as well as an update on our current pivotal programs and key goals for 2021, Adam Walton will then provide an update on our commercialization efforts.

Jenna Bosco: Adam Waldman will then provide an update on our commercialization efforts before handing the call over to the operator to begin the Q&A. Before we begin, I would like to remind everyone that various remarks that we make about our future expectations, plans, and prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those intended.

Before handing the call over to the operator to begin the Q&A session.

Before we begin I would like to remind everyone that various remarks that we make about our future expectations plans and prospects constitute forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated factors that may affect TG therapeutics operations include various risk factors that can be found in our most recent form 10-K for the year ended December 31, 2020, and other filings with the securities.

Jenna Bosco: Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our most recent Form 10-K for the year ended December 31, 2020, and other filings with the Securities and Exchange Commission. 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, www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I'd like to turn the call over to Sean Power, our CFO.

And Exchange Commission.

In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

We specifically disclaim any obligation to update or revise any forward looking statements.

This conference call is being recorded for audio rebroadcast on Tg's web site Www Dot TG therapeutics Dot com, where it will be available for the next 30 days now I'd like to turn the call over to Sean power our CFO.

Yeah.

Thank you Jenna and thanks, everyone for joining us as you may be aware our financial results were released this morning and can be viewed on the investors and media section of our website.

Sean A. Power: Thank you, Jenna, and thanks, everyone, for joining us. As you may be aware, our financial results were released this morning and can be viewed in the Investors and Media section of our website. I'll kick things off with our cast members.

I'll kick things off for cash position, we're happy to have substantially strengthened our balance sheet over the course of 2020, allowing us to end the year with more than $600 million in cash cash equivalents and investment securities.

Sean A. Power: We are happy to have substantially strengthened our balance sheet over the course of 2020, allowing us to end the year with more than $600 million in cash, cash equivalents, and investment securities. Now, I will turn you for a moment to the financial results. Excluding non-cash items, our net loss for the fourth quarter of 2020 was approximately $54.7 million compared to $34 million in the fourth quarter of 2019. The increase we've seen in net loss as compared to the 2019 quarter is primarily related to increased G&A expenses associated with our preparations for the commercialization and launch of EUCONIC, which occurred in the first quarter of 2021.

Turning for a moment to the financial results.

Excluding non cash items, our net loss for the fourth quarter of 2020 was approximately $54 7 million compared to $34 million in the fourth quarter of 2019.

The increase we've seen in net losses compared to the 2019 quarter is primarily related to increased G&A expenses associated with our preparations for the commercialization and launch of Eugonic, which occurred in the first quarter of 2021.

Our GAAP net loss for the fourth quarter of 2020 inclusive of noncash items was $88 2 million for 70 171 cents per share compared to a net loss of $39 6 million or <unk> 44 per share during the comparable quarter in 2019.

Sean A. Power: Our gap net loss for the fourth quarter of 2020, inclusive of non-cash items, was $88.2 million or $0.71 per share compared to a net loss of $39.6 million or $0.44 per share during the comparable quarter in 2019.

Our net loss for the year ended December 31, 2020 exclude.

Sean A. Power: Our net loss for the year ended December 31, 2020, excluding non-cash items, was approximately $199.1 million compared to $161.4 million for the 2019 year-end. The year-over-year increase in net loss is primarily driven by an increase in commercialization costs, as previously discussed. On the R&D front, we incurred approximately $21 million in licensing milestones during 2020, which was partially offset by a decrease in manufacturing and CNC expenses as compared to the prior period.

Excluding noncash items was approximately.

$199 1 million compared to $161 4 million for the 2019 year end.

The year over year increase in net loss is primarily driven by an increase to be commercialization costs as previously discussed.

On the R&D front, we incurred approximately 21 million in licensing milestones during 2020, which was partially offset by a decrease in manufacturing and CMC expenses as compared to the prior period.

The GAAP net loss for the 2020 year end inclusive of non cash items was $279 4 million or $2 42 per share compared to a net loss of $172 9 million for $1 96 per share for the year ended December 31 2019.

Sean A. Power: The GAAP net loss for the 2020 year-end, inclusive of non-cash items, was $279.4 million, or $2.42 per share, compared to a net loss of $172.9 million, or $1.96 per share, for the year-end of December 31, 2019.

In terms of what we expect moving forward I think approximately $50 million per quarter for 'twenty 'twenty. One similar to 2020 is probably in line with our expectations. We expect to see decreases in R&D over the next few quarters as some of our large trials wind down. However, this will likely be offset by an increase in commercialization.

Ben says over those seen in 2020.

Sean A. Power: In terms of what we expect moving forward, I think approximately $50 million per quarter for 2021, similar to 2020, is probably in line with our expectations. We expect to see decreases in R&D over the next few quarters as some of our large trials wind down. However, this will likely be offset by an increase in commercialization expenses over those seen in 2020. Looking out further, R&D expenses should pick back up in Q4 and through 2022 as we hit peak enrollment in our next generation of pivotal trials, including our MZL and FL confirmation studies and our triple therapy trials in CLL.

Looking out further R&D expenses should pick it picked back up in Q4 and through 2022 as we hit peak enrollment in our next generation of pivotal trials, including our M. E. L. F. L conformation study and our triple therapy trials and C. L. L C.

Similarly in 2022, we will see further growth for SG&A with our potential launches in C. L O and N S.

Taken together without accounting for revenues, we believe our current cash will take us out into 'twenty two 'twenty three.

With that I'll now turn the call over to Mike Weiss, our executive Chairman and CEO.

[laughter].

Great. Thank you Shawn and thank you Jenna and thanks for all of you for joining us this morning.

2021, and certainly off to an exciting start with the recent accelerated approval of our first medicine umbrella listed now called Uchronic for the treatment of relapsed or refractory marginal zone and Follicular lymphoma.

Sean A. Power: Similarly, in 2022, we will see further growth in SG&A with our potential launches in CLL and MS. Taken together, without accounting for revenues, we believe our current cash will take us out into 2023. With that, I'll now turn the call over to Mike Weiss, our Executive Chairman and CEO. Great. Thank you, Sean. And thank you, Jenna.

This was an incredible achievement for the team and we are thankful for everyone, who helped along the way to reach this exciting milestone.

With you Konica approval, our company has transformed into a fully integrated commercial organization and we are incredibly proud of the progress already made under the leadership for that and Walton our chief commercialization officer will join us shortly to provide some color around the early commercialization efforts.

Before I hand, it over to Adam I wanted to highlight some of the important accomplishments for 2020 that have positioned us for an exciting 'twenty, one and beyond I want to give special thanks to the T. G team for working tirelessly to achieve these important milestones.

Michael S. Weiss: And thanks to all of you for joining us this morning. 2021 is certainly off to an exciting start with the recent accelerated approval of our first medicine, Umbralicid, now called Eukonics, for the treatment of relapsed or refractory marginal zone and follicular lymphoma. This was an incredible achievement for the team, and we are thankful to everyone who helped along the way to reach this exciting milestone. With Econic Approval, our company has transformed into a fully integrated commercial organization, and we are incredibly proud of the progress already made under the leadership of Adam Waldman, our Chief Commercialization Officer, who will join us shortly to provide some color around early commercialization.

With that let's review some of these significant developments over the past 12 months or so.

First and foremost I mentioned at the outset of these prepared remarks, we received the exciting news early last month that the FDA granted accelerated approval of your clinic for the treatment of adult patients with relapsed or refractory marginal zone lymphoma, who have received at least one prior anti CD 20, based regimen and adults with relapsed or refractory.

Follicular lymphoma, who have received at least three prior lines of systemic therapy.

On the data front December was about as good as it gets for us at TG.

Okay.

At Ash, we presented pivotal results from both our unity NHL trial as well as our unit D. C. C O L trial.

Michael S. Weiss: Before I hand it over to Adam, I want to highlight some of the important accomplishments for 2020 that have positioned us for an exciting 21 and beyond. I want to give special thanks to the TG team for working tirelessly to achieve these important milestones. With that, let's review some of these significant developments over the past 12 months or so. First and foremost, as I mentioned at the outset of these prepared remarks, we received the exciting news early last month that the FDA granted accelerated approval of Eukonic for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CB20-based regimen and adults with relapsed or On the data front, December was about as good as it gets for us at TG.

For the unity NHL study the data showed that umber listen mono therapy demonstrated an overall response rate of 49, 3% in patients with relapsed or refractory marginal zone lymphoma.

45, 23% overall response rate in patients with relapsed or refractory Follicular lymphoma.

Free unity CLO, we presented data demonstrating that Youtube achieved the primary endpoint of improving progression free survival over standard of care chemo immunotherapy and those results for consistent for patients with treatment naive CLO as well as relapsed or refractory CLO and.

In addition, there was a significant improvement in overall response rate secondary endpoint.

Finally at Ash, we also presented data from the Triple combination of Youtube plus banana clocks in patients with relapsed or refractory C. O L. And also the triple combo data from Youtube for TG 17 O. One in patients with relapsed refractory CLO or other b cell lymphomas.

Michael S. Weiss: At ASH, we presented pivotal results from both our Unity NHL trial as well as our Unity CLL trial. For the UNITY-NHL study, the data showed that umbilicid monotherapy demonstrated an overall response rate of 49.3% in patients with relapsed or refractory marginal zone lymphoma and a 45.3% overall response rate in patients with relapsed or refractory follicular lymphoma. For Unity CLL, we presented data demonstrating that U2 achieved the primary endpoint of improving progression-free survival over standard-of-care chemotherapeutics, and those results were consistent for patients with treatment-naive CLL as well as relapsed or refractory CLL.

I do encourage investors to carefully review both of those presentations.

And the Youtube Vin study.

In the 19 patients who completed 12 cycles of treatment essentially 12 months of treatment, we reported a 100%.

Overall response rate with a 96% of the patients achieving undetected for M. R. D in the peripheral blood and 77% for those patients achieving undetectable MRV in the bone marrow.

Also folks should take another look at it the 17 or one data or be TK inhibitor.

In addition to the Youtube plus 17 O. One combination data, which looked very promising I would note that the single agent. Overall response was 95% and the 'twenty feel all patients treated at the 200 milligram once daily dose level. So clearly a very active agent I would also encourage folks to look at the safety and <unk>.

Michael S. Weiss: In addition, there was a significant improvement in overall response rate, the secondary endpoint. Finally, at ASH, we also presented data from the triple combination of U2 plus banana claps in patients with relapsed or refractory CLL and also triple combo data from U2 plus TG1701 in patients with relapsed refractory CLL or other B-cell lymphomas.

Our ability of that same 200 milligram dose and compare that to the Tolerability and Tox profile of the best Beach, He can't inhibitors, both cooled down for non covalent.

You can find it pretty interesting and potentially could be a differentiator.

Also in December just a few days after the Ash conference, where we presented all that exciting b cell cancer data.

Michael S. Weiss: I do encourage investors to carefully review both of those presentations, in the YouTube Venn Study. In the 19 patients who completed 12 cycles of treatment, essentially 12 months of treatment, we reported 100% overall response rate with 96% of the patients achieving undetectable MRD in the peripheral blood, and 77% of those patients achieving undetectable MRD in the bone marrow. Also, folks should take another look at the 1701 data, our BTK inhibitor. In addition to the U2 plus 1701 combination data, which looked very promising, I would note that the single agent overall response was 95 percent in the 20 CLL patients treated at the 200 milligram once daily dose level. So, clearly, a very active agent.

We were excited to announce the much anticipated top line results of our fee of our two phase III studies of who will be touching that in relapsing forms of multiple sclerosis, our ultimate one and two studies.

Both trials met their primary endpoint of significantly reducing annualized relapse rate with a P value of less than 0.005 in each study.

Of particular interest was that an annualized relapse rate of less than a 0.10 was achieved in both studies and the toxin that orange.

Something that has been described with Kols as breaking an important barrier.

One that has not been achieved before in any previous M. S phase III trial.

As you can imagine we are very excited about these topline results and we're working hard to finalize the full data for presentation, including safety and secondary analysis, which is targeted for the first half of this year.

And will be used to support Uberly, RMS BLA submission, which is targeted for mid year.

Michael S. Weiss: I would also encourage folks to look at the safety and tolerability of that same 200mg dose and compare that to the tolerability and toxic profile of the best BTK inhibitors, both covalent and non-covalent. I think you'll find it pretty interesting and potentially could be a differentiator. Also, in December, just a few days after the ASH conference where we presented all that exciting B-cell cancer data, we were excited to announce the much-anticipated top-line results of our two Phase III studies of lubotoxinab in relapsing forms of multiple sclerosis, our ultimate one and two studies.

As noted and as you noted the initial feedback from the Kols community has been very positive and supports our confidence that emmis has an important opportunity for TG.

Yeah.

Finally also in December.

Based on the positive unity CLO data, we announced that we commenced the rolling BLA submission for <unk> in combination with <unk>. So that's our Youtube combination for patients with C. O L for which we are targeting completion of the submission in the first half of this year.

2020 was also a year, where TG as drugs were recognized by a number of high impact medical journals for publication.

Leading the final phase II results of moving to touch on that in multiple sclerosis in the multiple sclerosis Journal a final phase two data volume.

Michael S. Weiss: Both trials met their primary endpoint of significantly reducing annualized relapse rates with a p-value of less than.005 in each study. Of particular interest was that an annualized relapse rate of less than.10 was achieved in both studies in the Oobletoximab arm, something that has been described by the KOLs as breaking an important barrier, one that has not been achieved before in any previous MS phase 3 trial. As you can imagine, we are very excited about these top-line results, and we are working hard to finalize the full data for presentation, including safety and secondary analysis, which is targeted for the first half of this year and will be used to support an OOBLEE RMS BLA submission, which is targeted for midyear.

The weighted umber listen in patients with C. C. L. L who are intolerant to prior be Teekay for P. O three K inhibitors in the journal blood.

The final results results from the phase three genuine trial evaluating what tucks them out plus ibrutinib in patients with relapsed or refractory high risk <unk>.

O L was published in the lancet hematology.

And finally on the preclinical side data describing the use the unique immuno modular Tory effects of our Melissa was published in blood advances a journal of the American Society for Hematology.

And last but certainly not least in 2020, we strengthened our cash position.

And as Sean mentioned, we were able to end the year with approximately $600 million in cash.

And we also strengthened our team with the addition of approximately 140, new Fulltime TG member team members dedicated to our long term vision of developing and commercializing novel treatment options for patients with B cell diseases.

Michael S. Weiss: As noted, the initial feedback from the KOL community has been very positive and supports our confidence that MS is an important opportunity for TG. Finally, also in December, based on the positive UNITY CLL data, we announced that we commenced the rolling BLA submission for aducuximab in combination with eukonics, that is, our U2 combination, for patients with CLL, for which we are targeting completion of this submission in the first half of

As you can see 'twenty 'twenty was a data rich regulatory driven year, where we grew our organization and paved the way for impactful milestones to be achieved in 2021, starting with the approval last month of Eugonic in both relapsed or refractory marginal and Follicular lymphoma.

With that as a segue.

I'm excited to turn the call over to our Chief commercialization Officer, Adam Waldman to share some thoughts on the launch of the economy, following which the operator will begin the Q&A session.

Adam.

Yeah.

Okay.

Yeah, Thanks, Mike and thanks, everyone for joining us this morning.

I'm excited to share some highlights on the progress of the new product launch.

Michael S. Weiss: 2020 was also a year where TG's drugs were recognized by a number of high-impact medical journals for publication, including the final phase two results of lupituximab in multiple sclerosis in the Multiple Sclerosis Journal, and the final phase two data evaluating umbilicib in patients with CLL who are intolerant to prior BTK or PI3K inhibitors in the journal Blood. The final results from the Phase III Genuine Trial, evaluating ubutuximab plus abrutinib in patients with relapsed or refractory high-risk CLL, were published in the Lancet Hematology.

[noise] approval occurred after the close of the fourth quarter, we will not reported any sales metrics today.

Third I will highlight our accomplishments and provide some high level qualitative insights into what we're seeing in the launch so far.

As Mike mentioned, we were extremely pleased on February February 5th to.

To receive accelerated approval for <unk> in both relapsed and refractory marginal zone Follicular lymphoma ahead of their paducah dates.

And even with the earlier than anticipated approval, especially in Follicular lymphoma, which happened more than four months before the Paducah date.

We were fully prepared for launch.

Within hours of the approval, we launched Eugonic dot com initiated distribution of our marketing materials and digital campaigns and our TG patient support program was up and running.

Michael S. Weiss: And finally, on the preclinical side, data describing the unique immunomodulatory effects of armabilicib were published in Blood Advances, a journal of the American side of hematology. And last but certainly not least, in 2020, we strengthened our cash position, and as Sean mentioned, we were able to end the year with approximately $600 million in cash.

Just as a reminder, T J patient support is a comprehensive program designed to support patients through their treatment journey and the reimbursement process.

Our field teams across sales medical marketing and access were fully trained preapproval and started engaging with them with customers on <unk> label on day one.

We have since had very positive interactions with physicians mid levels nurses pharmacists and administrators since launch.

Michael S. Weiss: We also strengthened our team with the addition of approximately 140 new full-time TG team members dedicated to our long-term vision of developing and commercializing novel treatment options for patients with B cell disease. As you can see, 2020 was a data-rich, regulatory-driven year where we grew our organization and paved the way for impactful milestones to be achieved in 2021, starting with the approval last month of EUCONIC for both relapsed or refractory, marzozone, and follicular lymphoma.

We have had good access to our target accounts and reception to your chronic has been overwhelmingly positive.

Many are excited to have a new treatment option for patients with these diseases in which there is no standard of care. After your initial first line treatment.

Customers have been impressed with the safety and Tolerability profile, a lack of a black box warning low rates of discontinuation. The unique mechanism of action simple dose modifications and consistent efficacy across both marginal zone and Follicular lymphoma.

We have trained several several experts speakers to help educate the community on your chronic and have already conducted multiple national and regional speaker programs within the key community oncology networks.

Michael S. Weiss: But that is a segue, and I'm excited to turn the call over to our Chief Commercialization Officer Adam Waldman to share some thoughts on the launch of Eukonics, following which the operator will begin the Q&A session.

We have also been working closely with our advocacy partners, who are excited about the approval of the panic.

Adam Waldman: Yeah, thanks, Mike. And thanks, everyone, for joining us this morning. I'm excited to share some highlights on the progress of the Eukonics launch. However, because approval occurred after the close of the fourth quarter, we will not report any sales metrics today.

It had been educating the marginal zone follicular patient community about this new treatment option.

We thank them for all they do for patients and we remain committed to supporting the lymphoma community moving forward.

Despite the unprecedented weather in the central and southern United States over the past month.

Adam Waldman: Instead, I will highlight our accomplishments and provide some high-level qualitative insights into what we are seeing in the launch so far. As Mike mentioned, we were extremely pleased on February 5th to receive accelerated approval for Econic in both relapse and refractory, marginal zone, and follicular lymphoma ahead of their PDUFA date. And even with the earlier than anticipated approval, especially in follicular lymphoma, which happened more than four months before the PDUFA date, we were fully prepared to launch.

Connick left our three PL to facility within one week of approval.

Drug is now fully available in the channel through our specialty pharmacy, and specialty distributors and prescriptions are being processed.

Our market access team along with the medical team has been actively meeting with payers to ensure that your connick is placed on formulary and available for patients. So.

So far our conversations with these payers have been very productive and.

And we remain confident we will achieve broad coverage for FDA label for you caught it.

Within days of the approval. We were also pleased to see that the national comprehensive cancer network or the N. C. C. N added your contact to its clinical practice guidelines in compendium for.

Adam Waldman: Within hours of the approval, we launched eukonic.com, initiated the distribution of our marketing materials and digital campaigns, and our TG patient support program was up and running. Just as a reminder, TGA Patient Support is a comprehensive program designed to support patients through their treatment journey and the reimbursement process.

Both marginal zone Follicular lymphoma.

This is a positive step forward and provides additional support for the adoption of the economy.

While we are in the very early days post FDA approval, we believe the commercial launch thus far is off to a very strong start.

Adam Waldman: Our field teams across sales, medical, marketing, and access were fully trained pre-approval and started engaging with customers on Econics Label on day one. We have since had very positive interactions with physicians, mid-levels, nurses, pharmacists, and administrators since launch. We have had good access to our target accounts, and reception for Eukonic has been overwhelmingly positive.

And with that thank you everyone for your time this morning, and I will turn the call over to the conference operator to begin the quite the question answer session.

Thank you at this time, we'll be conducting a question and answer session. If you'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. You May press star two if you'd like to remove your question from the queue for participants.

Adam Waldman: Many are excited to have a new treatment option for patients with these diseases in which there is no standard of care after initial first-line treatment. Customers have been impressed with the safety and tolerability profile, the lack of a black box warning, low rates of discontinuations, the unique mechanism of action, simple dose modifications, and consistent efficacy across both marginal zone and follicular lymphoma. We have trained several expert speakers to help educate the community on Eukonic and have already conducted multiple national and regional speaker programs within key community oncology networks.

Using speaker equipment, it may be necessary to pick up your handset before pressing the star key.

One moment, please while we poll for questions.

Your first question comes from the line of Alexia Young with Cantor Fitzgerald. Please proceed with your question.

Hey, guys. Congrats on all the progress over time in 'twenty. It really did play out the way you kind of said it Mike.

I have two questions. One just maybe if you can talk a little bit more I know it sounds like it's going quite well with the launch, but just talk a little bit more about you know kind of you know how the market with a low it might've been a little bit hesitant on older P. I three kinases and aimed at just kind of give us. Some flavor for you now is that evolving is it really because of the label or is it because the totality, but do you see.

Adam Waldman: We have also been working closely with our advocacy partners who are excited about the approval of Eukonics and have been educating the marginal zone and follicular patient community about this new treatment option. We thank them for all they do for patients, and we remain committed to supporting the lymphoma community moving forward. Despite the unprecedented weather in the central and southern United States over the past month, Connick left our 3PL facility within one week of approval.

And that you know people are more open minded around you know kind of the safety profile that <unk> provides and then the second question is I'm, just and multiple sclerosis, or and that would lead you to combinations. How are you guys thinking about timelines around maybe starting on other studies, maybe in like P. P. M S or another indications there. Thanks.

Hey, Mike do you want me to start with the first one.

Yes, please file some huge oh, yeah makes sense. Okay. Thanks, Alicia for the question. Yeah. You know we we obviously we knew that there was an overhang amongst the class, but what we're seeing so far is that Oh, you connick is seen as differentiated both from a mechanism of action stand.

Adam Waldman: The drug is now fully available in the channel through our specialty pharmacy and specialty distributors, and prescriptions are being processed. Our market access team, along with the medical team, has been actively meeting with payers to ensure that Eukonic is placed on formulary and available to patients. So far, our conversations with these pairs have been very productive, and we remain confident we'll achieve broad coverage for our FDA label for eukonics. Within days of approval, we are also pleased to see that the National Comprehensive Cancer Network, or the NCCN, added EUCONIC to its clinical practice guidelines and compendium for both marginal zone and follicular lymphoma.

Point.

Being specific to the delta in with CK, one Epsilon inhibition.

As well as the safety profile. It is distinctly different from what physicians are expecting with the class. So.

So that's what we've seen so far and the feedback from the physicians is a very consistent with what we thought and what we've seen in the market research as well.

And on the M. S N autoimmune front I'd say, we have not made a decision on how we want to address P. P. M S.

But we are looking at study designs. There we're looking at study designs for switch studies.

Adam Waldman: This is a positive step forward and provides additional support for the adoption of EUCONIC. While we are in the very early days post FDA approval, we believe the commercial launch thus far is off to a very strong start. And with that, thank you everyone for your time this morning, and I will turn the call over to the conference operator to begin the question and answer session. At this time, we will be conducting a question and answer session.

From <unk> to <unk> and we're also continuing to evaluate some other indications.

Say our target is to have at least one one additional study open before yearend and we'll we'll keep you posted.

Yes.

Great. Thank you.

Yep you got.

Your next question comes from the line of Roger song with Jefferies. Please proceed with your question.

Great. Thank you for Whitestone that progress.

Maybe one question for Adam is since this is the only a two day launch and assets.

Adam Waldman: If you would like to ask a question, please press star 1 on your telephone keypad. 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.

We see some.

Pretty positive signals, but moving for ward like next few quarters, what kind of for launch metrics for that Oh chronic for for nickel.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. Your first question comes from the line of Alethea Young with Cancer Fitzgerald. Please proceed with your question. Hey guys, congrats on all the progress made in 2020. It truly did play out the way you kind of said it, Mike.

Imagine the zone, you're well.

Expecting to update to us.

Yeah. Thanks for the question.

So in future.

Calls, we'll obviously report on net revenue.

In addition, we will we'll plan on sharing both quantitative and qualitative insights and metrics to demonstrate our progress with our strategy and execution.

And end market performance, where we see appropriate.

Alethea Young: I have two questions. One, just maybe if you can talk a little bit more, I know it sounds like it's going quite well with the launch, but just talk a little bit more about, you know, kind of, you know, how the market was a little, might have been a little bit hesitant of older PI3 kinases, and, you know, just kind of give us some flavor for, you know, is that evolving? Is it really because of the label or is it because of the totality?

I guess I guess some examples maybe.

And I don't you know, we're still working through exactly how we're going to do this for examples maybe.

You'll qualitative customer insights and feedback.

Like I just provided but.

We'll look at customer engagement metrics, our performance in targeted customer accounts and of course, our progress with payer coverage and reimbursement.

That's the plan, so far but as I said that we'd continue to work on it.

But hopefully that answers your question.

Yeah. That's helpful. Thank you, Okay and our next question maybe for Adam or Mike We understand that we'll have a hand just follow on with the.

Adam Waldman: But do you sense that, you know, people are more open-minded around, you know, the safety profile that Econics provides? And then the second question is, just in multiple sclerosis or in that with the U2 combinations, how are you guys thinking about timelines for maybe starting other studies, maybe in like TTMS or in other indications there? Thanks. Hey, Mike, do you want me to start with the first one? Yes, please, Cyrus. I'm huge.

Yes question for that Kathryn K cash listings and you have seen this kind of differentiation in the part of your background.

Some doctors and they just curious.

Expectations for them the sales for ramp up youre expecting somewhere a quick ramp up the cost.

Since the item from the.

And finishing you had been talking away just because we know a lot of the.

Adam Waldman: Go ahead, Adam. Yeah, that's okay. Yeah, thanks. Thanks, Alethea, for the question. Yeah, you know, obviously, we knew that there was an overhang amongst the class, but what we're seeing so far is that EUCONIC is seen as differentiated both from a mechanism of action standpoint, being specific to the Delta and with CK1 epsilon inhibition, as well as from a safety profile that is distinctly different from what physicians are expecting with the class.

Community Doc already use the panic during the day you need to and.

And that channel earlier clinical studies.

Yeah, I'll jump in and you can add on top of that Adam I mean, I think we're still you know from where I sit in my communications with with with the Street I think we want to take a tempered approach and the early engagement looks quite quite positive.

But we're still dealing with relatively small patient populations with marginal zone and Follicular are and I don't want I don't want people to assume that are you know what this thing is going to ramp overnight. So rapidly I mean, it could net out I may give you a different answer, but I think as a corporate and so I think we want to be very cautious.

Adam Waldman: So that's what we've seen so far, and the feedback from physicians is very consistent with what we thought and what we've seen in the market research as well. And on the MS and autoimmune front, I'd say we have not made a decision on how we want to address PPMS, but we are looking at study designs there. We're looking at study designs for switch studies from Ocrevus to Ubile.

Yeah, Mark Zone, Follicular are really great indications for us to start with.

But obviously, where we're expecting.

The the ramp to really starts to go into play when we start launching into scale L.

Adam you could add on top of that but.

Yeah I agree I mean, you know we're enthusiastic about the reaction from physicians, who are definitely seeing a differentiated profile.

Michael S. Weiss: And we're also continuing to evaluate some other indications. I'd say our target is to have at least one additional study open before year-end. And we'll keep you posted. Great, thank you. Yes, you got it.

As I mentioned, an MLA and safety.

So that's good but we don't want to get ahead of ourselves I think Mike mentioned. This is these are relatively small patient populations. It also was in indolent disease and we.

Roger Song: Your next question comes from the line of Roger Song with Jeffries. Please proceed with your question. Great. Thank you. Congratulations on the progress. Maybe one question for Adam is, since this is early for the launch and certainly we see some pretty positive signals, but moving forward, like the next few quarters, what kind of launch metrics for the Eukonics, for horticulture, and the marginal zone will you be expecting to update us? Yeah, thanks for the question. So in future calls, we'll obviously report on net revenue.

We still are dealing with COVID-19 and patient Theres, just not as much urgency as is with the acute diseases patients will come in and <unk>.

But it will be paced and we'll have to watch that and see how it goes but I agree with what Mike said.

Got it yeah, that's in there.

Yeah. So yeah good to have some color around the expectation. Thank you, Mike and Adam that's it for me.

Yeah.

Alright, Thanks Roger.

Your next question comes from the line of Eric Joseph with Jpmorgan. Please proceed with your question.

Adam Waldman: In addition, we plan on sharing both quantitative and qualitative insights and metrics to demonstrate our progress with our strategy and execution and market performance where we see appropriate. I guess, I guess some examples, maybe, you know, and I don't, you know, we're still working through exactly how we're going to do this, but examples may be, you know, qualitative customer insights and feedback, like I just provided, but... We'll look at customer engagement metrics, performance, and targeted customer accounts, and, of course, progress with payer coverage and reimbursement. That's the plan so far, but as I said, we will continue to work on it. But I hope that answers your question.

Hi, Good morning. This is a hold on for Eric Thanks for taking the questions just to for us.

Firstly can you talk about how physicians view the competitive safety profile of Calkins with a simple.

And what's what's the anticipated competitive dynamic for you too.

Relative to Calkins.

Secondly.

Yeah.

Data readouts from the Ultra V trial.

Should we expect adult day and figured out with response rates.

Something more mature like a duration of response and PFS.

Yeah.

Sure So I'll.

I'll take a crack at the that's the first question and the crack for the second one in Adams chime in.

So you know calculates versus ibrutinib.

Again, it's where the.

It's sort of a third hand, where we're talking about drugs that aren't ours, but.

My impression is that.

There are some folks who who believe the Kaufman says a marginally better.

The city and Tolerability profile over Ibrutinib.

Adam Waldman: Yeah, that's helpful. Thank you. Okay, and the next question may be for Adam or Mike. We understand the overhand just follow on Alicia's question for the PI3K class, but since you have seen this kind of differentiation and the positive feedback from doctors, And I'm just curious about your expectations for the sales ramp up. You're expecting some quick ramp up because of the enthusiasm from the physicians you have been talking with because we know a lot of the community docs already used Eukonics during the UNITY NHL or earlier clinical studies. Yeah, I'll jump in, and you can add on top of that, Adam.

I think overall Ibrutinib is and will continue to be the market leader.

In and C O L in terms of PTK inhibitors of choice.

Yeah, we've seen in in Bruton, Abe patients, who have a grown intolerant that golan calc ones.

Think over 50% of them, we'll continue to have the same issues that they had with ibrutinib I'll double check those numbers, but.

We did it we did it and intolerant study that was.

Showed a much cleaner profile for patients coming off of Ibrutinib.

Seeking another therapy in terms of patients that were intolerant that David mentioned was published in blood. So Ah I think whereas you chew fit in again whatever issues associated with Ibrutinib.

Michael S. Weiss: I mean, I think we're still, you know, from where I sit in my communications with the street, I think we want to, you know, take a temperate approach. I mean, early engagement looks quite positive, but we're still dealing with relatively small patient populations with marginal zones and follicular. I don't want people to assume that, you know, this thing is going to ramp up overnight so rapidly. I mean, it could, and Adam may give you a different answer, but I think, as a corporate answer, I think we want to be very cautious.

Is also associated with calculus right. So they are they are not.

Separate from the general toxicity profile, you're still going to see about half the patients with bleeding and bruising issues, you're still going to see several percentage of the patients with the day faith in cardiovascular risk.

And if a patient has preexisting cardiovascular conditions.

And or they have some bleeding risks or they have drug drug interactions that folks are worried about particularly lots of patients need to be antifungals, all of which are contra indicated with both calkins and ibrutinib. So Youtube really fits in nicely into patients who either have seen a beat TK inhibitor in house.

Michael S. Weiss: You know, marginal zone and follicular are really great indications for us to start with, but obviously, we're expecting the ramp to really start to come into play when we start launching into scale. Well, Adam, you could add on top of that, but... Yeah, I agree.

Come off for Tolerability issues or in patients who walk in the door and have some of the issues that I've mentioned, a Youtube really provides a nice we believe opportunity for patients to get them.

Adam Waldman: I mean, you know, we're enthusiastic about the reaction from physicians who are definitely seeing a differentiated profile in terms of, as I mentioned, MOA and safety. So that's good, but we don't want to get ahead of ourselves. I think Mike mentioned these are relatively small patient populations. It also is an indolent disease, and, you know, we still are dealing with COVID, and patients, there's just not as much urgency as with the acute diseases. Our patients will come in and, you know, but it will be paced, and we'll have to watch that and see how it goes. But I agree with what Mike said. I got it.

This treatment option that doesn't have those issues.

With respect to ultra V. The.

The the data for the study is a single arm trials for the most important data is overall response and duration of response.

That's typically how have the single arm studies work will of course overtime, followed patients not only for duration of response for for progression free survival and overall survival, but the the endpoints for this trial the primary endpoint, I believe is or or or see our and our and we also.

Roger Song: Yeah, that's understood. And yeah, so yeah, good to have some color around the expectations. Thank you, Mike and Adam. That's it from me. Congratulations again.

I think a very important metrics for this study are rates of undetectable minimal residual disease.

<unk> continues to be a remarkably high AR in the in the early data.

Operator: Great. Thanks, Roger. Your next question comes from the line of Eric Joseph with JP Morgan. Please proceed with your question. Hi, good morning. This is Rahul on Phonetic.

Data so as we mentioned in the prepared remarks.

19 patients were presented from the U two than phase one program.

We have completed 12 months of therapy, where we showed 100% overall response rate.

Eric William Joseph: Thanks for taking the question. This is two from me. Firstly, can you talk about how physicians view the comparative safety profile of Kalkins versus Improvica and what's the anticipated competitive dynamic of U2 relative to Kalkins? and secondly, questions about the earliest data readouts from the ULTRA-V trial. Should we expect a top-line readout with response rates or something more mature like a duration of response in PFS? Sure, so I'll take a crack at the first question and a crack at the second one, and Adam can chime in.

With a 96% undetectable I'm or day in the blood and 77% undetected for on the bone marrow realm.

Relative to other.

<unk> therapies I believe that in relapsed patients those are the best undetectable on more day rates that had been reported to date.

And it's only 19 patients thus far so we've got room to grow that we will have.

By the end of this year, we could have anywhere from 50 to 100 patients potentially to report on.

With those same metrics.

But that's the that's the plan.

The next step in that program to get folks Oh look ahead is.

Michael S. Weiss: So, you know, Kalkwins versus Bruton, you know, again, it's... We're, it's sort of a third hand, we're talking about drugs that aren't ours, but my impression is that there are some folks who believe that Calquins has a marginally better toxicity and tolerability profile over Brutinib. But I think overall, Brutini We've seen in Brutinib patients who have grown intolerant to it that go on Calquins; I think over 50% of them will continue to have the same issue that they had with Brutinib.

Once we.

Complete the enrollment into the phase two portion of the phase three portion of that trial will open and then we will be looking for PFS endpoint.

That would be usable for for full approval.

For that helps at all.

Thanks for thanks.

Okay.

Your next question comes from the line of Ed White with H C. Wainwright. Please proceed with your question.

Okay.

Good morning, everyone and thanks for taking my question so.

Just on the <unk>.

C O L.

Submission.

I think.

Sean had mentioned.

Launches.

For CLO and M. S. In 2022, I'm just wondering if we can get your thoughts on.

A potential priority review if that's possible.

Michael S. Weiss: I'll double-check those numbers, but we did an intolerance study that showed a much cleaner profile for patients coming off of Brutinib seeking another therapy in terms of patients that were intolerant. That data we mentioned was published in Blood. So I think where you two fit in, again, whatever issue is associated with Brutinib is also associated with Calquins.

And and.

Earlier launch of CLO in 2021.

And then I also wanted to get your thoughts on Youtube pricing.

Yeah. So.

We're hopeful that we will receive priority review, we do have fast track designation, which doesn't fully entitled one to priority review, but we do think that that it puts us on the right track toward a priority review.

So we'll be pushing.

Pushing it.

Michael S. Weiss: So they are not... And separate from the general toxicity profile, you're still going to see about half the patients with bleeding and bruising issues. You're still going to see several percentage of the patients with AFib and cardiovascular risk. And if the patient has pre-existing cardiovascular conditions, or they have some bleeding risks, or they have drug-drug interactions that folks are worried about, particularly lots of patients need to be on antifungals, all of which are contraindicated with both calclins and abrutinib.

Forward and asking for certainly asking for prior to review.

And the second question in terms of Youtube pricing.

You know I think you know, where we would anticipate that Youtube pricing would be competitive and strategically be able to be price.

Versus other potential doublets that are available.

So you know right now.

You know we have a we have a price for for Melissa will soon at some point price does suck the map, but ideally when we put the two pieces together.

Michael S. Weiss: So U2 really fits in nicely with patients who either have seen a BTK inhibitor and have come off for tolerability issues, or in patients who walk in the door and have some of the issues that I've mentioned. U2 really provides a nice opportunity, we believe, for patients to get a treatment option that doesn't have those issues. With respect to ULTRA-V, the study is a single-arm trial, so the most important data are overall response and duration of response. That's typically how single-arm studies work.

And using whatever discounts makes sense, we will be able to put out a price said strategically puts us in a really nice competitive location versus some other doublets that are out there.

And CLO.

Thanks, Mike and.

Just a question on M. S launch again thinking of pricing, so youre launching in MFS and will launch in oncology as well.

How should we be thinking about pricing there and also where is it going to fit in the you know knowing the data that you know today, where is it going to fit in the changing treatment paradigm and M. S.

Michael S. Weiss: We'll, of course, over time, follow patients not only for duration of response but for progression of survival and overall survival. But the endpoints for this trial, the primary endpoint, I believe, are ORR or CR. And also, I think, very important metrics for this study are rates of undetectable minimal residual disease, which continues to be remarkably high in the early data. So, as we mentioned in the prepared remarks, 19 patients were presented from the U2, then the Phase I program, who had completed 12 months of therapy, where we showed 100% overall response rate with 96% undetectable MRD in the blood and 77% undetectable in the bone marrow. Relative to other therapies, I believe that in relapsed patients, those are the best undetectable MRD rates that have been reported to date.

Yeah, So I'll.

Start with the second part of that question and move back to the price and after that so.

Look our our beliefs are.

And we think the belief of the other participants in the CD 20 marketplace.

Or that you now see the twenties are gonna be moved earlier and earlier in.

In the treatment algorithm.

We think that's now.

Kind of excited to see our net of data at some point I haven't seen it yet but.

No evidence of disease activity as kind of an interesting measure and sort of gets people.

Thinking about.

The halting of the progression of these diseases are in the disease process. So.

Assuming that you know that.

Our day in and on data from the other Citi trends continue to support.

The fact that if you get them on a CD 20 early you can really arrest the disease process.

That's an exciting opportunity and so again, we think that will.

We will be moving early earlier and our positioning within the class a three C. D. 20, So we think CD twenty's will be the largest class of of M. S treatment options.

Michael S. Weiss: Again, it's only 19 patients thus far, so we've got room to grow that. We could potentially have anywhere from 50 to 100 patients to report on, with those same metrics. But that's the plan.

And we believe that a little bit talks of map is a very important position within that class a three as we've noted previously we think that the one hour infusion every six months.

Is a very convenient and fits within.

Michael S. Weiss: The next step in that program, to give folks a little look ahead, is once we complete enrollment in the Phase 2 portion, the Phase 3 portion of that trial will open, and then we will be looking for a PFS endpoint that would be usable for full approval. Hopefully, that helps, Raul. Thanks. Thanks. Yep. Your next question comes from the line Ed White with HC Wainwright. Please proceed with your question. Good morning, everyone.

The practice of of Emmis physicians, who like to see their patients at least every six months.

Getting them in with a one hour infusion is really quite convenient for both the patient and the physicians and it's in it's quite good for the infusion centers the ability to more patients in and out and handle more capacity, which is always always had at a premium.

We're also we can see you know off hand into the pricing aspect.

We've continued and we will continue to maintain that we believe that strategic strategically pricing low touch the mab.

Edward Patrick White: And thanks for taking my questions. So, just on the CLL. Submission.

<unk> is a way for us to gain market share.

Edward Patrick White: I think... Sean had mentioned launches for CLL and MS in 2022. I'm just wondering if we can get your thoughts on a potential priority review, if that's possible for an earlier launch of CLL in 2021. And then I also wanted to get your thoughts on U2 pricing.

And we do think that's as it stands right now the certainly based on the annualized relapsed rate data.

That we have and certainly the to date the best results.

And now we think that obviously will help the marketing team, but you know our goal is to bring every lever to the table to try to optimize our market share within what we believe is going to be the largest market opportunity for for M. S.

Michael S. Weiss: Yeah, so, um, we're hopeful that we'll receive priority review. We do have a fast-track designation, which doesn't fully entitle one to priority review, but we do think that it puts us on the right track toward priority review. So we'll be pushing forward and asking certainly for a private review. And the second question, in terms of YouTube pricing, you know, I think we would anticipate that YouTube pricing would be competitive and strategically be able to be priced versus other potential doublets that are available.

Great. Thanks for taking my questions Mike.

Sure. Thank you.

Yes.

Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Hi, Good morning, guys and thanks for taking the question.

Sure Matt.

More of a follow up on I guess, maybe for Adam I guess, given the lack of black box warning and the unique safety profile for Ya Connick, how are doctors I guess thinking about incorporating it into their treatment regimens and protocols for relapsed remitting.

Michael S. Weiss: So right now, we have a price for Umbralycid, and we'll soon at some point price Ubisuximab, but ideally, when we put the two pieces together and use whatever discounts make sense, we'll be able to put out a price that strategically puts us in a really nice competitive position versus some other doublets that are out there. Shabbat shalom.

Oh, sorry, not to be left for me and for relapsed refractory Follicular and marginal zone patients now.

Yeah, I mean, you said it I mean, the the fact is in this in this patient population Tolerability convenience play a critical.

Michael S. Weiss: Thanks, Mike, and just a question on the MS launch. Again, you know, thinking of pricing, so you're launching an MS, and we'll launch in oncology as well. How should we be thinking about pricing there? And, you know, also, where is it going to fit in the, you know, knowing the data that you know today, where is it gonna fit in the changing treatment paradigm in MS? Yeah, so I'll start with the second part of that question and move back to the pricing after that. Look, our belief, and we think the belief of the other participants in the CD20 marketplace, is that CD20s are going to be moved earlier and earlier in the treatment algorithm. We think that's...

<unk> role and is a top of mind for physicians treating patients with indolent diseases.

Such as Follicular and marginal zone.

You know our docks at least initially had been very very impressed with the data and marginal zone and.

See it as being an option right after first line therapy.

In Follicular.

Like the profile obviously there are.

A few other.

Approved agents, there, but they like the profile and.

See it is being used in the relapsed setting.

You know exactly where and in what order is still remains to be seen and we're talking to physicians about that but certainly in the.

The approved indications they think it's a very appropriate option.

And that's what we continue to talk to physicians about.

Michael S. Weiss: I'm excited to see our metadata at some point. I haven't seen it yet, but no evidence of disease activity is kind of an interesting measure and sort of gets people thinking about the halting of the progression of these diseases and the disease process. Assuming, you know, that our data and data from the other CD20s continue to support the fact that if you get them on a CD20 early, you can really arrest the disease process, that's an exciting opportunity.

Okay. That's helpful. And then Mike you you went into some detail in terms of the current PTK inhibitors on the market and you mentioned some data that was presented at ash for.

For 17 out one.

What what are you seeing so far in terms of the Tolerability profile for 17 at one that you'd think differentiates it from current PTK inhibitors available.

Yeah. So you know it is a it is early data, but when you look across you know the the what I call. The eight years of interest for boots UK inhibitors, there they're remarkably low.

Michael S. Weiss: And so, again, we think that we'll be moving earlier and earlier. And our positioning within the class of three CD20s, we think CD20s will be the largest class of MS treatment options, and we believe that Lubetoximab has a very important position within that class of three. As we've noted previously, we think that the one-hour infusion every six months is very convenient and fits within the practice of MS physicians who like to see their patients at least every six months.

With with 17 don't want to say 200 milligram dose levels. Thus far obviously, we need probably some more duration on there, but I think as a start looks quite good it to my knowledge no patients have have come off the drug for any dose drug related toxicities.

The the bleeding risk is is it bleeding and bruising risk is quite low so that thus far.

I think we're in close to the 15% range versus 50% for the established agents.

Michael S. Weiss: Getting them in with a one-hour infusion is really quite convenient for both the patient and the physicians, and it's quite good for the infusion centers, the ability to move patients in and out and handle more capacity, which is always at a premium.

You know again I think.

The the profile emerging like I said I do encourage folks to take a look for right now it's looking quite good and we'll update update that data as we as we get more so.

Michael S. Weiss: We're also, you know, we continue now, I'll head into the pricing aspect, we've continued, and we will continue to maintain that we believe that strategically pricing Lubetoximab is a way for us to gain market share. And we do think that, as it stands right now, certainly based on the annualized relapse rate data. [inaudible] Great. Thanks for taking my questions, Mike. Sure, Ed

There's an emerging profile.

With activity potentially are as good if not better than what's out there plus a safety profile, that's looking quite attractive.

Okay.

Last question don't want to leave Shawn out Hum.

You mentioned that there were about 21 million in milestone payments in 2020, what are your intensive milestone payments for 'twenty 'twenty, one and you see it on our radar.

Edward Patrick White: Thank you. Your next question comes from the line of Matt Kaplan with Lattenberg Daumann. Please proceed with your question. Hi, good morning, guys.

Sure.

Yeah.

Thanks for including me, Matt appreciate it.

So we are well.

So you have.

Some milestones associated with the approval of <unk>.

Matthew Lee Kaplan: And thanks for taking the question. I guess, more of a follow-up question, I guess, maybe for Adam, I guess, given, you know, the lack of a black box warning and the unique safety profile for eukonics. How are doctors, I guess, thinking about incorporating it into their treatment regimens and protocols for relapse-remitting? Relash Refractory, Flickler, and Marjol's.

Remember, let's have been in the first quarter here.

And potentially.

Some associated with the approval of <unk> later in the year. So we haven't fully disclosed what those look like but qualitatively I would tell you in line with our 2020.

Right.

Congrats on the progress guys and thanks for taking the question.

Thanks, Matt.

As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.

Adam Waldman: Yeah, I mean, you said it. The fact is, in this patient population, tolerability, convenience, play a critical role and are top of mind for physicians treating patients with indolent diseases, such as follicular and marginal zone. You know, docs, at least initially, have been very, very impressed with the data on marginal zone and, you know, see it as being an option right after first-line therapy. In follicular, they like the profile.

As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.

Moment, please while we poll for more questions.

Your next question comes from line of May Inc. My tiny with B Riley Securities. Please proceed with your question.

Oh, hi, good morning, Thanks for taking our questions and congrats on the progress so I don't see.

Do you see them I'd agree.

Which leads to a degree have you been granted a pause for them relative.

And then loans.

The stimulus day back on the Follicular mobile you know as you think about the risk benefit assessment that BMO has had that led to a little motto enable.

Adam Waldman: Obviously, there are a few other approved agents there, but they like the profile and see it as being used in the relapsed setting. You know, exactly where and in what order still remains to be seen, and we're talking to physicians about that, but certainly in the approved indications, they think it's a very appropriate option, and that's what we continue to talk to physicians about. That's helpful.

How is that kind of bet for them in their community.

I believe.

So do you buy it into the label or do you think.

Yeah.

On the occupancy side, maybe less but on the Tolerability profile, maybe more superior.

How do you how do you think about the risk benefit.

The ones on the labels and we'll have look bad.

Yes, Mike. Thank you Great question and yes for the first part is the Mtc and category to category two eh.

Michael S. Weiss: And, Mike, you went into some detail in terms of the current BTK inhibitors on the market, and you mentioned some data that was presented at ASH for 17.01. What are you seeing so far in terms of the tolerability profile for 1701 that you think differentiates it from the current BTK inhibitors available? Yeah, so, you know, it is, it is early data. But when you look across, you know, the, what I call the AESM interest for B2K inhibitors, they're remarkably low, with 1701 at the 200 milligram dose level thus far. Obviously, we probably need probably some more duration on there, but I think as a start, it looks quite good. To my knowledge, no patients have come off the drug for any dose-related drug-related toxicities.

In both Follicular and marginal zone.

And it is a.

Largely to the to the label. So it's a category for you to two way to answer your question and then as far as the risk benefit profile I mean, I think right now what we're hearing as physicians see this as a as a very effective and very well tolerated.

Option for their patients and in indolent lymphoma, and I think they see it as a really compelling option in both diseases.

You know as I mentioned it.

It's distinct from what they've seen from other peer three K a.

Inhibitors of what they would expect.

The lack of a black box warning does pop up is something that's differentiating.

And so I think they see a very good risk benefit profile that fits very well into the treatment paradigm.

Michael S. Weiss: The, you know, the bleeding risk is, bleeding and bruising risk is quite low thus far. I think we're in close to the 15% range versus 50% for the established agents. You know, again, I think the profile has emerged, and like I said, I do encourage folks to take a look, but right now, it's looking quite good, and we'll update that data as we get more. There's an emerging profile with activity potentially as good, if not better, than what's out there, plus a safety profile that's looking quite attractive. Okay, thanks. And last question: I don't want to leave Sean out.

For the specific patients.

Great.

And then switching to almost a.

Have you guys done any Oh I know you guys are so broad so it seemed to be down and it's a lot of volume but.

We are starting to see numbers of months for <unk>.

Also in the numbers Pete do you have any early kind of global perspective on what the number number that could.

Could be for.

For the books of Nab on BMS data that you have.

Sorry, Mike I didn't hear that it might be I don't know if you heard the question.

She is probably too early to say I mean, I think for the question.

Adam was.

We've seen some of the consumption numbers and I think you're asking me, what we see as projections for the numbers of patients that we could expect to see on overstock smell.

Sean A. Power: You mentioned that there were about 21 million in milestone payments in 2020. What are your intensive milestone payments for 2021 that you see on the radar? Thanks for including me, Matt.

Actually sorry, the number needed to treat NMD Ah boy.

Oh boy for a Crosby is different for you blend and I know, there's there could be some analysis that you could do with the.

Sean A. Power: I appreciate it. So we will obviously have some milestones associated with the approval of umbilicib in the first quarter here and potentially some associated with the approval of ubutuximab later in the year. So we haven't fully disclosed what those look like, but qualitatively, I would say in line with 2020. Congratulations on the progress, guys. Thanks for taking the questions. Thanks, Matt.

I E are they would be.

We have reported in the relative risk reduction have you guys done that yet and compare them with other CD brandy, that's kind of important for reimbursement.

Yeah, I'm not aware that we did that yet Adam has as Jamie and her team looked at them at this point or maybe they are in the process of looking at all.

Yeah, no not yet no we're in the midst for doing that right now.

We'll keep you posted on that one land.

Thank you I believe.

One of these conferences could have some interesting analysis that can be and.

And then Mike just.

Operator: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. One moment, please, while we poll for more questions.

A question on the earlier stage by blame anything active.

Activity you've done on the Iraq for them every day, we love this you're not seeing much about that in your leasing.

Hi, Blaine updates.

Anything you can provide day.

Yeah, So look where we're taking another look at that compound originally we were.

Mayank Mamtani: Your next question comes from Mayank Mamtani with B Riley Security. Please proceed with your question. Hi, good morning team.

Concerned about the Uh huh.

Preclinical tox profile for the agent, but we have some new folks on board and we're in the process of looking at that right now on letting them evaluate them as we're doing some new.

Mayank Mamtani: Thanks for taking our questions and congratulations on the progress. So, Adam, on the MTCN category, which category have you been granted umbrellaship in? And then, you know, just taking a step back on the follicular label, you know, as you think about the risk-benefit assessment that FDA may have had that led to a, you know, a little narrower label. So, how is that kind of different in the community?

I understand is we're going to do some new preclinical tests.

On the continent, otherwise it's it is it is near I N D ready so if.

The new team, including Dr. Owen O'connor, taking a look at this right now.

With our other scientific folks onboard so they'll take a look with fresh eyes and some fresh data.

And and make a determination on what they're thinking about what the compound, but it is reasonably close to try and be ready.

Mayank Mamtani: Like, are they kind of strictly abiding by the label, or do you think, you know, just on the efficacy side, maybe less so on the tolerability profile, maybe more superior? How do you think about the risk benefit, you know, relative to what regulators may have looked at? Yeah, Mayank, thank you. Great question.

And as they feel comfortable moving forward, we can live with for a pretty quickly.

Great. Thanks for taking my questions.

You got it.

Ladies and gentlemen, we have reached the end of the question and answer session and I'd like to turn the call back to Mr. Michael Weiss for closing remarks.

Great. Thank you and again, thanks, everybody. So I'd like to wrap up today's call. Once again, just reviewing the upcoming key goals and objectives. So at the top of the list of courses continue the execution of our commercialization of Uchronic umbrella SIB in relapsed refractory Muslim for.

Adam Waldman: And yes, so the first part is the NCCN category. It's a category 2A, in both the follicular and marginal zones, and it is largely to the label. So it's a category 2A, to answer your question.

Adam Waldman: And then as far as the risk-benefit profile, I mean, I think right now what we're hearing is physicians see this as a very effective and very well tolerated something that differentiates. And so I think they see a very good risk-benefit profile that fits very well into the treatment paradigm for these specific patients. Great, and then switching to MS, have you guys done anything? I know you guys are still processing the data, and it's a lot of volume, but we are starting to see numbers emerge for Ocrevus and Kissimmee also on the number-negative treatment.

<unk>, we're going to work hard to complete the rolling Biologics license application or BLA submission will be tough for Nab in combination with.

Since the treatment of patients with CLO that'll be including both previously untreated, so treatment naive and patients with relapsed or refractory <unk>.

CLS we.

We will be seeking.

Very simple label for the treatment of CLO with that application.

We plan to present final results from the ultimate one and two phase III trials evaluating tux madmen in Rms.

Adam Waldman: Do you have any early kind of qualitative perspective on what the number-negative treatment could be for Obituxinab from the MS data that you have? Sorry, Mike, I didn't hear the... Mike, I don't know if you heard the question.

And associated with that we look forward to submitting a BLA for <unk> in Rms.

Targeted for the middle of this year.

We're going to continue to advance our early pipeline candidates are 15 alone 17, or 18, one and that of course, we're looking at some of those preclinical compounds that were mentioned in the Q&A and later in the year, we plan to present updated data from Youtube.

Mayank Mamtani: I think it's probably too early to say, Mayank. I think the question, Adam, was, you know, we've seen some of the Cosimpton numbers, and I think you're asking, Mayank, what we see as projections for the numbers of patients that we could expect to see on Ubutoxinib? Actually, sorry, the number needed to treat NMT for across these different CB20s, I know there could be some analysis that you could do with the, you know, the ARR rate you have reported and the relative risk reduction, have you guys done that yet? And compared it to other CB20s?

Plus in the nine o'clock.

We've got our T. G 17, one beach K inhibitor that we'll presenting some more data on during the course of the year and you know hopefully again by year end, we'll potentially have our first data available on our P.

E G HN and one which is our C. D 47, CD 19 bi specific antibody so could shape up to be an exciting year. Both from the commercial launch perspective, but also from a.

Mayank Mamtani: It's kind of important for reimbursement. Yeah, I'm not aware that we did that yet, Adam. Has Jamie and her team looked at that at this point? Or maybe they're in the process of looking at that. Yeah, no, not yet.

From new registration filings potential approvals.

As well as a solid compounds coming through that through the pipeline. So behalf of all of us at T. G. I would like to thank our investigators and their patients of course, who are.

Adam Waldman: No, we're in the midst of doing that right. We'll keep you posted on that one, Mayank. Thank you. I believe one of these conferences could have some interesting analysis.

Participate in our trials and trust us as.

As well as our employees and shareholders for their continued support thanks again, everyone for joining us and have a great day.

Michael S. Weiss: And then, Mike, just a question on the earlier stage pipeline. Anything, any recent activity you've done on the IRAC for innovators? We've obviously not seen much about that in your recent pipeline updates, but anything you could provide there?

Yeah.

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

[music].

Michael S. Weiss: Um, yeah, so look, we're taking another look at that compound. Originally, we were concerned about the preclinical tox profile for the agent. But we have some new folks on board, and we're in the process of looking at that right now and letting them evaluate it. We're doing some new, my understanding is we're going to do some new preclinical tests on the compound. Otherwise, it is near IND-ready, so the new team, including Dr. O'Connor, is taking a look at this right now with our other scientific folks on board.

Yes.

[music].

Michael S. Weiss: So they'll take a look with fresh eyes and some fresh data and make a determination about what they're thinking about with the compound. But it is reasonably close to being IND-ready, and if they feel comfortable moving forward, we can move this forward pretty quickly. Great, thanks for digging into my questions. You got it. Ladies and gentlemen, we have reached the end of the question and answer session, and I'd like to turn the call back to Mr. Michael Weiss for closing remarks.

Hum.

[music].

Okay.

Michael S. Weiss: And again, thanks to everybody. So I'd like to wrap up today's call once again, just reviewing the upcoming key goals and objectives. So at the top of the list, of course, is to continue the execution of our commercialization of eukonic umbralisib and relapser of fracture, marginal, and follicular. We're gonna work hard to complete the rolling biologics license application, the BLA submission, with Tuxomab in combination with, for the treatment of patients with CLL. That will include both previously untreated, so treatment nave, and patients for relaxor refractory CLL. So we will be seeking a very simple label for the treatment of CLL with that application.

[music].

Michael S. Weiss: We plan to present final results from the Ultimate 1 and 2 Phase 3 Trials Evaluating Oobletuximab in RMS, and with that, we look forward to submitting a bill for Oobletuximab in RMS, targeted for the middle of this year. We're going to continue to advance our early pipeline candidates, 1501, 1701, 1801, and, of course, we're looking at some of those preclin And later in the year, we plan to present updated data from U2 plus and out-of-clock.

Michael S. Weiss: We've got our TG1701 BXK inhibitor that we're presenting some more data on during the course of the year. And hopefully again by year-end, we'll potentially have our first data available on our AGE 1801, which is our CD47, CD19 bispecific antibody. So it could shape up to be an exciting year, both from the commercial launch perspective, but also from new registration filings, potential approvals, as well as follow-up compounds coming through the pipeline.

Yeah.

[music].

Michael S. Weiss: So, on behalf of all of us at TG, I'd like to thank our investigators and their patients, of course, who participated in our trials and trust us, as well as our employees and shareholders for their continued support. Thanks again, everyone, for joining us, and have a great day. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. © transcript Emily Beynon, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? [inaudible] © BF-WATCH TV 2021, © The Ultimate Parody Site! ?? ?? ?? ?? ?? ?? ?? ?? ?? ??