The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Okay, very helpful, good. I guess, congrats on a very productive last 12 months here for the Company, which has included some announcements
of very positive Phase III data for the ULTIMATE study and for ublituximab in relapsing limiting MS. You have the approval of UKONIQ, umbralisib,
in February and the more recent launch of the products in relapsed/refractory marginal zone and follicular as well lymphoma.
And then also the presentation of full data set for the UNITY-CLL set as well as completion of a filing for the U2 combination in CLL. So very busy
12 months, action packed. Can you give us an update right now in terms of the commercial launch of UKONIQ and how is it going in the early
stages here?
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JULY 14, 2021 / 4:30PM, TGTX.OQ - TG Therapeutics Inc at Ladenburg Thalmann Virtual Healthcare Conference
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Okay, great. Perfect. So one of the things I guess you have to work to overcome is kind of the perception out there in terms of the PI3 kinase delta
class that the first-generation deltas kind of presented for you in terms of side effect profile. How are you working to overcome that and differentiate
UKONIQ in the marketplace now given that backdrop?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Okay. That's helpful. And then just in terms of blocking and tackling in terms of the launch, how is your current coverage right now for UKONIQ?
What's the coverage look like?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Let's shift gears a little bit. You talked about combination therapies early on in your introduction. You recently completed your BLA filing for U2 in
CLL. I guess that was earlier this year. You have a March -- PDUFA date coming up March next year. We expect you to receive a broad label for first
line and second line in CLL.
How do you think U2 will be incorporated into the treatment paradigm for this indolent disease? And I guess what is the overall commercial
opportunity for U2 you see in CLL?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Okay, okay. That's very helpful, thank you. And I guess given the attractive safety profile and tolerability profile of U2, how should we think about
it in the context of potential additional indications, specifically maybe earlier lines of therapy in follicular lymphoma or marginal zone?
And then also as you said, it could potentially be called in the backbone of therapy too before, and your vision to potentially have triple combination
therapies, U2 plus venetoclax, U2 plus a BTK inhibitor U2 plus a checkpoint inhibitor. Help us put that into -- talk about that and help us put that
into context of where U2 can go out in the future?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Very good, no, that's a great, great strategy out there. And in the time remaining, I want to shift gears a little bit to the autoimmune side. We could
talk about B-cell malignancies for a while longer, but you presented some very impressive Phase III data from the ULTIMATE program in terms of
-- it looks like it's a potential best-in-class anti-CD20 in MS. How are you -- how is that -- how is your work in preparation and the preparation of the
BLA moving forward right now for ublituximab?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Great. And then, thinking about ublituximab in MS, and there's a couple other anti-CD20s out there, how does ublituximab differentiate in this
class of drug? Both the data, side effect profile; give us some color there.
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Okay. And talk about the market opportunity in MS for ublituximab and what that market looks like right now.
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Great. And then, what is your current thinking, I guess, in terms of additional autoimmune indications for ublituximab and as you, kind of, embark
on the commercialization potentially next year after approval in MS? What are the other indications you're thinking about, if any for --?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc., - Analyst
: Well, Mike, I think we are running into the clock here. But thank you for participating today. Great to see you, and congrats again on all the progress
and good results.
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