Q2 2022 TG Therapeutics Inc Earnings Call
Operator: Thank you for joining us today.
Thank you for joining US today. This program will begin momentarily. Please remain on the line. Thank you for joining US today. This program will begin momentarily. Please remain on the line.
Yeah.
[music].
Operator: This program will begin momentarily.
Mayank Mamtani: And just two more quick follow-ups.
Operator: Please remain on the line.
Mayank Mamtani: Any plans for pursuing the primary progressive MS indication?
Greetings and welcome to the TG Therapeutics second quarter 2022 earnings Conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please press star one on your telephone keypad to enter the queue.
One should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn this conference over to your host Ms. Jenna Bosco.
Operator: This program will begin momentarily.
Mayank Mamtani: And then please remind us on the filing how that might be proceeding in Europe.
Operator: Please remain on the line.
Mayank Mamtani: And if that's, you know, if either of the two are important to any meaningful interest you may have gotten from a strategic, for example, you know, inbound you may have gotten from a life cycle or a geographical expansion standpoint.
Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the second quarter 2022 financial results and provide a business update are Michael Weiss, our chairman and Chief Executive Officer.
Operator: Greetings and welcome to the TG Therapeutics Second Quarter 2022 Earnings Conference Call.
Michael Weiss: Yeah.
Operator: At this time, all participants are in a listen-only mode.
Adam Waldman, our chief commercialization officer, and Sean power, our Chief Financial Officer.
Operator: A question and answer session will follow the formal presentation.
Michael Weiss: I mean, we continue to socialize the primary progressive area with KOLs.
Following our safe Harbor statement, Mike will provide an overview of our recent corporate developments Adam will 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.
Michael Weiss: I would say we have not
Before we begin I'd like to remind everyone that we will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance projected regulatory milestones clinical development plans and expectations for our marketed and pipeline products TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated.
Factors that may affect TG therapeutics operations include various risk factors that can be found in our SEC filings. In addition to 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.
<unk> 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 the I'd like to turn the call over to Mike Weiss our CEO .
Operator: Please press star 1 on your telephone keypad to enter the queue.
Michael Weiss: There's been a great demand or interest in studies in that area right now.
Operator: If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad.
Michael Weiss: We're continuing those discussions.
Thanks, Jenny and good morning, everyone and thank you for joining us I.
No doubt the second quarter of 2022 was a challenging one for us at T J.
But one also that has provided us with a renewed sense of purpose and focus.
Nearly all our efforts are now directed toward gaining FDA approval for Rituximab in relapsing forms of multiple sclerosis, which has a target to do so called date of December 28.
2022, and if approved being prepared to successfully launch <unk>.
We are dedicated to MSP patients can the entire M S community.
People will touch on that that has the potential to offer a valuable treatment alternative.
With an added convenience of a one hour infusion after the first dose. So while 2022 has not gone as expected. We believe there is an exciting opportunity ahead of us.
Have a great value to our shareholders.
Operator: As a reminder, this conference is being recorded.
Michael Weiss: For the most part, I think most physicians do view primary progression as just an extension, of RMS.
Let me get started off here by providing a brief regulatory update as many of you know a couple of months ago at the end of May we announced that the FDA extended our Producible date of December 28, 2022 as.
Operator: I would now like to turn this conference over to your host, Ms. Jenna Bosco.
Michael Weiss: Many of their opinions that may not have been picked up earlier, and they're pretty much, secondary progressive.
Michael Weiss: But we're continuing to look at ideas, and we keep bouncing ideas off KOLs, and we're, inviting ideas on studies for primary progressive that they think will be helpful, interesting, or possibly for registration.
Jenna Bosco: Thank you.
Michael Weiss: Then on Europe?
As we shared at the time the FDA extended the <unk> to allow time to review his submission provided by US in response to an information request from the FDA.
This is in Michigan, Verizon integration summary of certain existing clinical information.
That was previously provided to the FDA.
This submission as is customary during the BLA review process, we have continued to respond to additional FDA information requests.
To my knowledge, specifically related to the submission that resulted in the delay.
Generally speaking my team tells me that they believe the process is moving forward as expected.
Jenna Bosco: Welcome everyone and thanks for joining us this morning.
Michael Weiss: On Europe, we are continuing to work on the application.
With that let's talk a little bit about the commercial opportunity and some market dynamics.
Jenna Bosco: I'm Jenna Bosco and with me today to discuss the second quarter 2022 financial results, and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer,
Michael Weiss: Our expectation is that a European approval could be about six to nine months behind the, U.S. approval.
It's estimated that nearly 1 million Americans are currently living with Ms and approximately 70% to 75000 of them are and then our relapsing.
MF patients.
That will be seeking a new treatment each year currently about half of those seeking new treatment are receiving C V 'twenty based therapy.
We do recognize that we're competing against some larger competitors in this marketplace, but we believe our smaller size and nimbleness will play to where it's most important.
Certainly I mean, the size of the market there's room for all three CD twenty's to purchase meaningful levels as each offers patients and physicians unique attributes, which we see as only enhancing the patient experience.
And our discussions with EMS focused health care providers, we almost uniformly here that they believe early treatment with C. D twenties will dramatically change the long term outcome for these patients.
Which we see is enhancing the future demand for CB twenties.
Accordingly, we are optimistic that if <unk> is approved.
Additive in the CD 20, RMS marketplace at a Mormon our chief commercial officer.
Jenna Bosco: Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer.
Michael Weiss: In terms of commercialization in Europe, we're going to hopefully come up with our definitive, plan early next year.
Shortly to share his thoughts on the commercial opportunity as well as our plans for commercial.
We will also be joined by Sean power, our Chief Financial Officer to discuss our financial position. However, I wanted to highlight that the efforts we have taken as an organization.
To reduce our burn and ensure our current cash position will take us through the potential launch if we would talk to them that have thus far been very successful.
Q2 burn was even lower than we had projected coming in around $48 million for the quarter.
This is truly a company wide effort and I commend the entire T. G team for tightening their belts rolling up their sleeves and rally around our near term goal of approval and launch of who talks about our Max.
To get there, we closed or clause nearly all of our oncology programs in order to focus our resources and energy on Google It talks about the N M. S. We expect to revisit our pipeline.
And the potential for our drug candidates across a variety of b cell diseases, including oncology and the first half of next year ideally on the heels of an <unk> approval and launch in RMS.
Jenna Bosco: Following our Safe Harbor Statement, Mike will provide an overview of our recent corporate developments,
Michael Weiss: Great.
So with that let me turn the call over to Adam Wallman, our chief commercialization officer to share some insights on our commercials classroom, but talks about Adam.
Jenna Bosco: Adam will provide an update on our commercialization efforts,
Mayank Mamtani: Thanks for taking our questions, Mike.
Yes, Thank you, Mike and good morning, everyone.
Jenna Bosco: and Sean will provide a brief overview of our financial results
Michael Weiss: Sure.
I am pleased to provide an update on our core commercial activities as we continue to accelerate our preparation for the anticipated Uber talks a mab watch in relapsing forms of biomass.
Jenna Bosco: before turning the call over to the operator to begin the Q&A session.
Michael Weiss: Thank you.
Jenna Bosco: Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Operator: Our next question comes from the line of Prakhar Agrawal with Canterford Sherwood.
Our objectives for the launch of Hooper talks a mab or to one build a team of experienced professionals with deep knowledge of the M. S landscape and strong relationships across the M. S community.
Jenna Bosco: These forward-looking statements include statements about our anticipated future operating and, financial performance, including sales performance, projected regulatory milestones, clinical development plans, and expectations for our marketed and pipelined products.
Prakhar Agrawal: You may proceed with your question.
Jenna Bosco: TG cautions that these forward-looking statements are subject to risks that may cause our actual, results to differ materially from those indicated.
Prakhar Agrawal: Hi.
Jenna Bosco: Factors that may affect TG Therapeutics operations include various risk factors that can be found, in our SEC filings.
To ensure we are in a position to facilitate seamless access to a botox or mab for patients and providers and three drive demand for botox amount that approval with M. S specialists based on its differentiated profile.
Jenna Bosco: In addition to 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.
Jenna Bosco: This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where we'll be available for the next 30 days.
Jenna Bosco: Now I'd like to turn the call over to Mike Weiss, our CEO.
Prakhar Agrawal: Good morning, and thanks for taking my questions.
Over the last several months, we have significantly strengthened our core capabilities and commercial team, making critical hires in key roles recently, we added two general managers for our sales and access teams.
Michael Weiss: Thanks, Jenna, and good morning, everyone, and thank you for joining us.
Prakhar Agrawal: So firstly, a different follow-up on pricing.
Prakhar Agrawal: How do you plan to thread the needle on pricing discount versus making sure ASP doesn't get, too low for the infusion centers, making economics unattractive?
Prakhar Agrawal: Are there specific segments of the MS market that might be more receptive to this lower, pricing strategy?
Both of these key hires come from major M. S companies, each with 10 plus years and field based execution experience in the Ms market.
Prakhar Agrawal: I had a quick follow-up.
Adam Waldman: Do you want to go ahead on that one, Adam?
They joined our previously hired field based regional marketing team and medical teams and we will continue to build up our field teams under their leadership over the next few months as we approach our <unk> date in December .
Adam Waldman: Sure.
Adam Waldman: Yeah, I don't think we're prepared right now to say what our pricing strategy is going, to be. That said, we do believe there is a price out there that meets both payers' and providers' needs, and we're very aware of the dynamics that exist, and so we're working through all the different options, and we'll be ready to price it at launch.
Prakhar Agrawal: Got it.
We currently have approximately half of our field based team members hired and we will continue to hire over the coming quarters.
Prakhar Agrawal: And a quick follow-up.
In the key areas of sales axis and medical.
Prakhar Agrawal: If the drug gets approved in December, what's the earliest timeline by when you can get, a permanent J-code?
We have been able to attract exceptional talent and we continue to receive an incredible amount of interest from people wanting to join our outstanding team as our momentum builds towards dislodge.
Prakhar Agrawal: Thank you.
People see the opportunity to make a difference with people talks a mab and want to work with the high caliber individuals we have already hired and are eager to eager to be part of what we're building.
We are a small biotech company, but we are laser focused on the EMS business and will undoubtedly be able to surround this drug with incredible an exceptionally talented and experienced people that truly care about patients.
In terms of the market and see the 20th as Mike said now account for approximately 50% of the dynamic market share in the U S.
Physicians have told us that their concerns around using CD twenty's in the pandemic era have largely dissipated and they are comfortable using these therapies.
We believe B cell therapy has become the gold standard in efficacy and will continue to grow in the future.
This is a significant established and growing market opportunity that we believe will talk some map is well positioned to capitalize upon.
Our teams continue to ramp up their activities actively engaging key participants of the M. S community.
Our confidence continues to grow as the feedback I know, we'll talk some about profile has been very positive and our belief is that there's a very compelling commercial opportunity for this product.
Little bit talks maps profile with the one hour infusion time and flexibility and administration will allow for potentially enhanced patient experience and approved.
Infusion efficiencies benefiting patients and providers alike.
Michael Weiss: No doubt the second quarter of 2022 was a challenging one for us at TG, but one also, that has provided us with a renewed sense of purpose and focus.
Michael Weiss: Yeah.
In summary, we continue to build and strengthen our commercial capabilities as we ready the organization for the full bill talks to map launch. We believe this launch represents a significant commercial opportunity in all of our attention focus and commercial resources are aimed at making this M. S launch a success.
Michael Weiss: Nearly all our efforts are now directed toward gaining FDA approval for Lituximab in relapsing, forms of multiple sclerosis, which has a target PDUFA goal dated December 28, 2022, and if approved, being prepared to successfully launch.
Michael Weiss: I believe that it's a six—oh, sorry, Mike.
Michael Weiss: We are dedicated to MS patients and the entire MS community, believe Lituximab has the potential, to offer a valuable treatment alternative with an added convenience of a one-hour infusion after the first dose.
Adam Waldman: Go ahead.
Everything we have learned from engaging with the EMS providers over the last several months only increases our confidence.
Michael Weiss: So while 2022 has not gone as expected, we believe there's an exciting opportunity ahead, of us that can provide great value to our shareholders.
Michael Weiss: No, go ahead.
Main bullish on the opportunity and whereas we know we'll need to prove it we felt very good about our preparations and our ability to execute on the objectives of the launch.
Michael Weiss: Let me get started off here by providing a brief regulatory update. As many of you know, a couple months ago at the end of May, we announced that the FDA, extended our PDUFA goal date to December 28, 2022. As we shared at the time, the FDA extended the PDUFA goal date to allow time to review, a submission provided by us in response to an information request from the FDA. The submission comprised an integration summary of certain existing clinical information that, was previously provided to the FDA.
With that I'll hand, it over to Sean power, our Chief Financial Officer I'll. Thank you for your time Sean.
Yes.
Michael Weiss: Since this submission, as is customary during a BLA review process, we have continued to, respond to additional FDA information requests, none to my knowledge specifically related to the submission that resulted in the delay.
Adam Waldman: It's a six-month process on the J-code.
Thanks, Adam and thanks, again to everyone for joining us this morning.
Earlier, we reported our detailed second quarter 2022 financial results, which can be viewed on the investors and media section of our website.
Michael Weiss: Generally speaking, my team tells me that they believe the process is moving forward, as expected.
Adam Waldman: So it's a six-month process on the J-code.
Adam Waldman: That said, you know, there are, you know, not everyone, but there's a decent amount, of physicians that are comfortable using a miscellaneous J-code, and people will use it before the permanent code is in place, based on our conversations with many physicians and offices.
For today's call I'll touch on a few highlights from the quarter, beginning with our cash position.
Michael Weiss: With that, let's talk a little bit about the commercial opportunity and some market dynamics. It's estimated that nearly 1 million Americans are currently living with MS, and approximately, 70,000 to 75,000 of them are relapsing MS patients that will be seeking a new treatment each year.
Prakhar Agrawal: Okay.
Michael Weiss: Currently, about half of those seeking a new treatment are receiving CD20-based therapy.
Ended the second quarter with approximately $231 million in cash cash equivalents and investment securities, which we believe will be sufficient to take us into the second half of 2023.
Michael Weiss: We do recognize that we are competing against some larger competitors in this marketplace, but we believe our smaller size and nimbleness will play to our advantage, and most importantly, given the size of the market, there's room for all three CD20s to participate at meaningful levels, as each offers patients and physicians unique attributes, which we see as only enhancing the patient experience.
Prakhar Agrawal: Thank you.
Michael Weiss: In our discussions with MS-focused healthcare providers, we almost uniformly hear that they, believe early treatment with CD20s will dramatically change the long-term outcome for these patients, which we see as enhancing the future demand for CD20s.
As Mike alluded to we are pleased to report that our burn for the second quarter of 'twenty two came in under our previously guided range of $50 million to $55 million.
Handing at approximately 48 million for the quarter, which is the result of our focused and determined streamlining and cost savings measures.
Michael Weiss: Accordingly, we are optimistic that if Lubetoximab is approved, we'll be competitive in the CD20, RMS marketplace.
Michael Weiss: Adam Waldman, our Chief Commercial Officer, will join us shortly to share his thoughts
Our GAAP net loss for the second quarter of 'twenty, two was approximately 40 million or <unk> 30 per share, which was a decrease of $38 million from Q2 of 'twenty, one where we saw a net loss of approximately $78 million or 59 cents per share.
As compared to the prior year quarter. The decrease was driven by across the board decreases in R&D and SG&A, primarily due to a streamlining of our oncology operations and <unk>.
Shifting focus to our M S development and a launch preparation efforts.
The GAAP net loss for the six months ended June 30th 22 was $109 5 million or <unk> 81 per share compared to a net loss of $169 1 million or $1 28 per share for the comparable period in 2021.
Representing a decrease in net loss of approximately 60 million period over period.
Michael Weiss: on the commercial opportunity as well as our plans for commercialization.
In terms of what we expect moving forward, we project a burn for the remaining quarters of 'twenty two to average between 45 and $50 million down rather sharply from where we had been previously tried doing which we believe leaves us well positioned through the anticipated M. S. Producer date later this year.
Michael Weiss: We will also be joined by Sean Power, our Chief Financial Officer, to discuss our financial
Operator: Ladies and gentlemen, we have reached the end of today's question-and-answer session.
With that I will now turn the call back over to the conference operator to begin the Q&A.
Michael Weiss: position. However, I wanted to highlight that the efforts we have taken as an organization to reduce, our burn and ensure our current cash position would take us through the potential launch of Lubetoximab have thus far been very successful. Our Q2 burn was even lower than we had projected, coming in around $48 million for the quarter. This is truly a company-wide effort, and I commend the entire TG team for tightening, their belts, rolling up their sleeves, and rallying around our near-term goal of approval and launch of Lubetoximab in RMS.
Michael Weiss: I would like to turn this call back over to Mr. Mike Weiss for closing remarks.
At this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two to remove your question from the queue for participants using speaker equipment, and maybe necessary for you to pick up.
Michael Weiss: To get there, we closed or paused nearly all our oncology programs in order to focus our, resources and energy on Lubetoximab in MS. We expect to revisit our pipeline and the potential for our drug candidates across a, variety of B-cell diseases, including oncology, in the first half of next year, ideally on the heels of a Lubetoximab approval and launch in RMS.
Michael Weiss: So, with that, let me turn the call over to Adam Waldman, our Chief Commercialization
Michael Weiss: Great.
Michael Weiss: Thank you.
Your handset before pressing the star keys, one moment, while we poll for questions. Our first question comes from the line of Ed White with H C. Wainwright you May proceed with your question.
Adam Waldman: Officer, to share some insights on our commercial plans for Lubetoximab.
Michael Weiss: And thanks again, everyone, for joining us this morning.
Michael Weiss: As I mentioned throughout the call, our primary focus is on working with the FDA with the goal of getting UbiTux approved to treat patients with lapsing forms of multiple sclerosis by the PDUFA goal, date of December 28, 2022.
Okay.
Good morning, Thanks for taking my questions.
Adam Waldman: Adam?
First on the sales just Adam I was wondering if you could tell us.
How you're positioned with the sales team were you able to leverage and it gives the oncology sales team or are the a M.
M S Salesforce gonna be all new hires.
Adam Waldman: Yep.
Michael Weiss: We believe we have made the necessary changes to our organization to ensure the runway and structure to be commercially successful if approved, and we're excited about the potential of UbiTuxMab to be a meaningful treatment option for patients with RMS.
Hey, good morning, Ed Yeah, it's a different customer base. So no we would have to hire new people for the EMS we.
Adam Waldman: Thank you, Mike, and good morning, everyone.
Adam Waldman: I am pleased to provide an update on our core commercial activities as we continue, to accelerate our preparation for the anticipated Lubetoximab launch in relapsing forms of MS. Our objectives for the launch of Lubetoximab are to, one, build a team of experienced professionals, with deep knowledge of the MS landscape and strong relationships across the MS community, two, ensure we are in a position to facilitate seamless access to Lubetoximab for patients and providers, and three, drive demand for Lubetoximab at approval with MS specialists based on its differentiated profile.
It would not be using our oncology sales team.
Adam Waldman: Over the last several months, we have significantly strengthened our core capabilities and commercial, team, making critical hires and key roles. Recently, we added two general managers for our sales and access teams. Both of these key hires come from major MS companies, each with 10-plus years in field-based, execution experience in the MS market.
Adam Waldman: They join our previously hired field-based regional marketing team and medical teams, and we will continue to build up our field teams under their leadership over the next few months as we approach our PDUFA date in December. We currently have approximately half of our field-based team members hired, and we will, continue to hire over the coming quarters in the key areas of sales, access, and medical.
Okay, and just on and I would just add to that right and I'll just add to that while the the end of the spirit, let's call. It the sales force or much of the.
Adam Waldman: We have been able to attract exceptional talent, and we continue to receive an incredible, amount of interest from people wanting to join our outstanding team as our momentum builds towards this launch. People see the opportunity to make a difference with Ubitoximab and want to work with the high caliber individuals we have already hired and are eager to be part of what we are building.
Adam Waldman: We are a small biotech company, but we are laser focused on the MS business and will undoubtedly be able to surround this drug with incredible, exceptionally talented and experienced people that truly care about patients.
Other teams.
We'll be we'll have a lot of overlap so our access team is the same and.
Adam Waldman: In terms of the market, CD20s, as Mike said, now account for approximately 50% of the dynamic market share in the U.S.
Adam Waldman: Physicians have told us that their concerns around using CD20s in the pandemic era have largely dissipated and they are comfortable using these therapies.
Adam Waldman: We believe B-cell therapy has become the gold standard in efficacy and will continue to grow in the future.
In their field basis, so there's some overlap but the actual sales force themselves will be different.
Okay. Thanks, Mike.
Michael Weiss: Thanks again for joining us this morning, and we look forward to sharing additional exploratory analysis, one and two data sets, at the upcoming Congress in October.
Adam Waldman: This is a significant established and growing market opportunity that we believe Ubitoximab is well positioned to capitalize upon.
Michael Weiss: Thank you.
And.
I know you might not be able to say anything for competitive reasons, but I just wanted to get your thoughts on the M S pricing strategy.
Adam Waldman: Our teams continue to ramp up their activities, actively engaging key participants of the MS community.
Adam Waldman: Our confidence continues to grow as the feedback on Ubitoximab profile has been very positive and our belief is that there is a very compelling commercial opportunity for this product. Ubitoximab's profile with the one hour infusion time and flexibility in administration will allow for potentially enhanced patient experience and improved infusion efficiencies, benefiting patients and providers alike.
Adam Waldman: In summary, we continue to build and strengthen our commercial capabilities as we ready the organization for the Ubitoximab launch. We believe this launch represents a significant commercial opportunity and all of our attention, focus, and commercial resources are aimed at making this MS launch a success. Everything we have learned from engaging with the MS providers over the last several months only increases our confidence. We remain bullish on the opportunity and whereas we know we will need to prove it, we feel very good about our preparations and our ability to execute on the objectives of the launch.
And if there's anything you can share with us.
Adam Waldman: With that, I will hand it over to Sean Power, our Chief Financial Officer, and I will thank you for your time.
Yeah at that point, we we don't have a lot to share yeah, yeah sorry.
Sean Power: Sean?
Sean Power: Thanks, Adam, and thanks again to everyone for joining us this morning.
Sean Power: Earlier, we reported our detailed second quarter 2022 financial results, which can be viewed on the investors and media section of our website.
Sean Power: For today's call, I will touch on a few highlights from the quarter, beginning with our cash position. We ended the second quarter with approximately $231 million in cash, cash equivalents, and investment securities, which we believe will be sufficient to take us into the second half of 2023.
At this point, we don't have a lot to share other than we're actively engaging in payer conversations to inform our strategy.
Sean Power: As Mike alluded to, we are pleased to report that our burn for the second quarter of 2022 came in under our previously guided range of $50 to $55 million, landing at approximately $48 million for the quarter, which is the result of our focused and determined streamlining and cost savings measures. Our gap net loss for the second quarter of 2022 was approximately $40 million, or $0.30 per share, which was a decrease of $38 million from Q2 of 2021, where we saw a net loss of approximately $78 million, or $0.59 per share.
Sean Power: As compared to the prior year quarter, the decrease was driven by across-the-board decreases, in R&D and SG&A, primarily due to a streamlining of our oncology operations and a shift in focus to our MS development and launch preparation efforts.
Sean Power: The gap net loss for the six months ended June 30, 2022, was $109.5 million, or $0.81, per share, compared to a net loss of $169.1 million, or $1.28 per share, for the comparable period in 2021, representing a decrease in net loss of approximately $60 million, period over period.
And we will continue to do that as we get closer to launch.
Okay. Thanks, and just a last question if I may how should we be thinking about your oncology assets.
Or are you still enrolling or excuse me not enrolling but are still following patients that have already been enrolled in studies I believe be producing any data.
From ongoing studies and are strategically how are you thinking about this or are you looking for partners or perhaps outright sales of assets. Thank you.
Yeah. Thanks, Dan So I think most importantly strategically we are in a holding pattern in.
Sean Power: In terms of what we expect moving forward, we project our burn for the remaining quarters, of 2022 to average between $45 million and $50 million, down rather sharply from where we had been previously trending, which we believe leaves us well-positioned through the anticipated MS PDUFA date later this year.
Preparing ourselves to look at those programs on the other side of our of the elite hopefully approval. So.
I don't think we made any decisions about how we're going to move forward with those and in terms of whats going on some of the studies, we're continuing our patients.
And you know, we're we're obviously not looking too.
To present data at this moment, it's not.
Not a core focus its possible we do have some collaborators it's possible some data will come out.
But it's not it's not a high priority for us right now.
Yeah.
Okay. Thanks, Mike for taking my questions.
Yep.
Sean Power: With that, I will now turn the call back over to the conference operator to begin the Q&A.
Operator: Have a great day.
Our next question comes from the line of Eric Joseph with JP. Morgan You May proceed with your question.
Operator: At this time, we will be conducting a question-and-answer session.
Operator: If you would like to ask a question, please press star 1 on your telephone keypad.
Operator: A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove your question from the queue for participants using speaker, equipment.
Operator: This concludes today's conference.
Hi, Good morning, guys. Thanks for taking my questions.
Operator: It may be necessary for you to pick up your handset before pressing the star keys.
Operator: You may disconnect your lines at this time.
Operator: One moment while we poll for questions.
Operator: Thank you for your participation.
So first just hoping to get a better sense of where things are in the review cycle for <unk>.
Operator: Our first question comes from the line of Ed White with HG Wainwright.
Yes.
Whether you have specific feedback on the additional information.
Ed White: You may proceed with your question.
On the response to the additional information request from FDA and also whether you reached the point of labeling discussions and then secondarily.
Ed White: Good morning.
Ed White: Thanks for taking my question.
Ed White: First on the sales, just, Adam, I was wondering if you could tell us how your position with, the sales team, were you able to leverage any of the oncology sales team, or are the, MS sales force going to be on new hires?
Just wanted to get your current thoughts as to the importance of a sub Q formulation.
To being competitive in the CD 20 ml space.
And to the extent OUI is amenable to a sub Q formulation or are there any plans near term to explore that quickly. Thanks.
Adam Waldman: Hey, good morning, Ed.
Adam Waldman: It's a different customer base, so no, we would have to hire new people for the MS.
Sure.
Adam Waldman: We would not be using our oncology sales team.
Ed White: Okay.
Terms of the F D a.
In our prepared remarks mentioned that.
Ed White: And just on, you know, I know...
We have not had any further questions as a follow up to the submission that we made that caused the delay and we continue to work back and forth with yet.
Permission request.
In terms of thoughts on sub Q formulation.
And as you'll be amenable to it.
Yes, we believe it's certainly amenable to to sub Q formulation.
We just.
Besides the strategic impact Crossrail.
So that's where we are waiting for the landscape you know again getting much below I mean.
Getting the sub two versus an hour infusion, we're doing research right now.
Is it.
Friends.
A number of areas of sub Q4 are the IV to subcutaneous has not been successful in certain areas. It has been successful.
So I think where we're currently evaluating but yes.
It can be made into a sub kit.
Okay, great. Thanks for taking the questions.
Thank you Sir.
Michael Weiss: Ed, I'll just add to that.
Operator: Enjoy the rest of your day.
Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. You May proceed with your question.
Michael Weiss: Go ahead.
Operator: [music]
Hi, good morning, and thanks for taking my questions.
I guess, maybe a question for Adam how should we think about access and especially kind of thinking about it for next year if approved at the end of December .
How does that access ramp up over the next sort of for 2023, and how do you drive access.
Ed White: Ed, I'll just add to that.
Yeah. Thanks for the question Matt.
So first and foremost we we've been engaging with payers for for over a year. At this point. We think early engagement will will help in terms of getting coverage as quickly as possible and those conversations continue to be ongoing I think in general are they.
Michael Weiss: While the end of the spear is the sales force, much of the other teams will be, will have, a lot of overlap.
Michael Weiss: So, our access team is the same, and they're field-based, so there's some overlap, but, the actual sales force themselves will be different.
Welcome a new entrant into the market in the CD 20 class. They obviously are from a overall spend perspective. This is an area of focus for them.
Believe competition has the potential decreasing overall net cost in the space.
Ed White: Okay.
And.
You know and in general we think we can get rapid access into 2023 upon approval.
Ed White: Thanks, Mike.
We've been doing up into this point is aimed at making sure we can get coverage as quickly as we possibly can.
Ed White: And, you know, I know you might not be able to say anything for competitive reasons, but, I just wanted to get your thoughts on the MS pricing strategy, if there's anything you can share with us.
Are you know a big part of that another aspect of that is just making sure that we have a patient support services. We know that that's really important in this space.
And we are.
Well positioned right now.
Not only in back to Ed's question, we've we have existing infrastructure on patient support they were able to leverage for this M. S launch we're in good shape and building a best in class patient support services and hub and hub.
For for patients with Mds, and we believe that will will help with access as well.
Michael Weiss: Yeah, Ed, at this point, we don't have a lot to share.
Okay. That's very helpful. And then in terms of driving driving demand, what's the feedback you've been getting from our kols and other others in the treatment space in terms of the ore.
Mobile is a differentiated profile and what what what do they see as important characteristics that could help to drive demand there.
Okay.
Michael Weiss: Yeah.
Yeah, I mean, I think first and foremost it's the it's the one hour infusion.
Michael Weiss: Yeah, sorry.
Think that that continuously comes up as being an important differentiator.
Michael Weiss: At this point, we don't have a lot to share, other than we're actively engaging in peer, conversations to inform our strategy.
Michael Weiss: And we will continue to do that as we get closer to launch.
Ed White: Okay, thanks.
I also think the overall tolerability profile of the drug and the.
The infusion experience overall is something that physicians have noted as being very important.
Ed White: Just a last question, if I may.
You know obviously, the best thing best a R. R that that's ever been reported in our phase III study is important but again without without head to head trials, you know hard to hard to make the claim that it's better from an efficacy perspective, although they are is certainly.
Ed White: How should we be thinking about your oncology assets?
You know eye popping or something that at least gets people's attention.
And so you know overall I think with the one hour infusion the efficacy and the safety and Tolerability profile I think it's the whole package that makes it a very compelling and value add.
Entrant into the market.
Yeah, I'll add on top of that not all that on top of that.
Hum.
I've been on the on the road personnel at the summer meeting with physicians and other health care providers and what's interesting to see is that it's not one thing.
<unk> necessarily that gets everyone, but there seems to be for everyone. So as Adam mentioned, we've had people tell us.
Look I look at your data and I see it's one.
One relapsing every 14 years versus one relapsed and every seven years broker base why would I use a purpose.
Present, the facts right.
Particularly will find what they're most interested in it and as Matt had mentioned, sometimes it's the overall tolerability profile and of course quite frequently it's the one hour infusion. So just to add on top again from personal experience out down the road.
We're seeing a lot of good feedback across the board.
Alright, Thanks, a lot.
Our next.
Next question comes from the line of my Young Mcdonald with B. Riley you May proceed with your question.
Good morning team. Thanks for taking our question. So just maybe a follow up on the FDA review discussions.
Just curious if anything.
Anything pertaining to standard of care differences in the U S and maybe the geographies that you would have conducted I've made wanting to have.
Come up and and and and also if you can compare contrast.
The similar three months delays, we've seen video creators and get them then the bus.
Yeah. So I mean look you know.
The.
The delays and <unk> and and.
Because simply received were also three months of their review cycle was.
<unk> was pushed back by three months ours was.
Is it any other way for us to compete.
Other than that Oh, Covid specific he said it was the CMC issue.
And you can simply said it was.
To an ordinary review issue or.
Or ordinary information request.
We.
Do not have enough deep.
Tried to compare and contrast, the two and.
In terms of.
After your review again in her prepared remarks.
<unk> stated that.
We have not heard any follow up from the.
Specifically related to the request that had caused the delay and we're continuing to work with the FDA and answering their information request.
Bid and just do more good follow ups of any plans for pursuing the primary progressive Ms indication and then can you remind us on the.
The filing how that might be proceeding in Europe , and if that's it.
I did have to do.
And boy didn't do any meaningful interest you may have gotten some are strategic for example.
In value they have gotten from.
Lifecycle other geographical expansion standpoint.
Yeah, and then we continue to socialize the primary progressive.
Hum.
Area with Kols.
Hum.
I'd say, we have not.
Great.
And your interest in our studies in that area right now we're continuing those discussions.
For the most part I think most physicians.
Do you view prime or just an extension of our medicine.
Many of their opinions that may not have been picked up here.
And they're pretty much secondary progressive.
But we're continuing to look at ideas and when we keep bouncing ideas off Kols and we're inviting ideas on study.
Studies for primary progressive that they think will be helpful interesting or possibly for registration.
And then on Europe .
In Europe .
We are continuing.
Continuing to work on the application our expectation is that our European approval could be.
About six to nine months behind the.
U S approval.
In terms of commercialization in Europe .
We're going to hopefully come up with our our definitive plan early next year.
Great. Thanks for taking my questions.
Sure. Thank you.
Our next question comes from the line of Paccar.
With Cantor Fitzgerald you May proceed with your question.
Hi, good morning, and thanks for taking my questions. So firstly a different follow up on pricing how do you plan to thread the needle on a pricing discount versus making sure ESP doesn't get too low for the infusion centers, making economics on that I'm not attractive.
Are there specific segments of the EMS market that might be more receptive to this lower pricing strategy and had a quick follow up.
We're going to go ahead on that one Adam.
Sure Yeah, I don't think we're prepared right now to say, what what our pricing strategy is going to be.
That said, we do believe there is.
There is a price out there that that meets both payers and providers.
Needs.
And we are very aware of the dynamics that exist.
So we're working through.
Through all the different options and we'll we'll be ready to price it at launch.
Got it and a quick follow up if the drug gets approved in December what's the earliest timeline by when you can get a permanent J code.
Yeah.
Yeah.
Yeah, I believe I believe that is a it's a six oh sorry, Mike go ahead.
No. It's just it's a six month to six month process on the J code.
So it's a six month, it's a six month process on the J code that said you know there are not.
Not everyone, but there's a decent.
Amount of physicians that are.
Multiple using a miscellaneous J code.
And people will use it before the permanent code is in place.
Based on our conversations with with many physicians.
In offices.
Okay. Thank you.
Ladies and gentlemen, we have reached the end of today's question answer session I would like to turn this call back over to Mr. Mike Weiss for closing remarks.
Ed White: Are you still enrolling, or excuse me, not enrolling, but are still following patients, that have already been enrolled in studies?
Great. Thank you and.
Thanks again, everyone for joining us this morning as I mentioned throughout all our primary focus is on working with the F. T. H with the goal of getting a little bit tougher proved to treat patients with lapsing forms of multiple source.
Ed White: Will you be producing any data from ongoing studies?
Ed White: And strategically, how are you thinking about this?
Ed White: Are you looking for partners, or perhaps outright sales of assets?
By the producer goal date of December 28, 2022, we believe we have made the necessary changes to our organization to ensure runway and structure to be commercially successful if approved.
Ed White: Thank you.
Michael Weiss: Yep.
Michael Weiss: Thanks, Chad.
Michael Weiss: So, I think most importantly is strategically, we are in a holding pattern and preparing, ourselves to look at those programs on the other side of the OOBLEE, hopefully approval.
Michael Weiss: So I don't think we made any decisions about how we're going to move forward with those.
Michael Weiss: And in terms of, you know, what's going on, some of the studies, we're continuing to follow, patients and, you know, we're obviously not looking to present data at this moment.
Michael Weiss: It's not a core focus.
Operator: Our next question comes from the line of Eric Joseph with JPMorgan.
Michael Weiss: It's possible.
Michael Weiss: We do have some collaborators.
Michael Weiss: It's possible some data will come out, but it's not a high priority for us right now.
Michael Weiss: Okay.
Michael Weiss: Thanks, Mike, for taking my questions.
Eric Joseph: You may proceed with your question.
Michael Weiss: Yep.
Cited about the potential to move the trucks, Matt to be meaningful treatment option for patients to the RMS. Thanks again for joining us This morning, and we look forward to sharing additional exploratory analysis.
Eric Joseph: Hi.
Eric Joseph: Good morning, guys.
Eric Joseph: Thanks for taking the questions.
Eric Joseph: So, first, just hoping to get a better sense of where things are in the review cycle for, OOBLEE MS, whether you had specific feedback on the additional information on the response to the additional information request from FDA, and also whether you've reached a point of labeling discussions.
Eric Joseph: And then, secondarily, just wanted to get your current thoughts as to the importance, of a sub-Q formulation to being competitive in the CD20 MS space.
Operator: Our next question comes from the line of Mayank Mamtani with
Eric Joseph: And to the extent OOBLEE is amenable to a sub-Q formulation, are there any plans in, your term to explore that clinically?
Mayank Mamtani: B. Riley.
Michael Weiss: Thanks.
Michael Weiss: Sure.
One or two datasets and the upcoming.
Michael Weiss: In terms of the FDA, I think in our prepared remarks we mentioned that we have not had, any further questions as a follow-up to the submission that we made that caused the delay, and we continue to work back and forth with the FDA on information requests.
Michael Weiss: In terms of thoughts on sub-Q formulation and is OOBLEE amenable to it, yes, OOBLEE, is certainly amenable to sub-Q formulation.
Michael Weiss: We just haven't decided if that's a strategic impact for us where we are evaluating.
Congress in October Thank you and have a great day.
Michael Weiss: The landscape, you know, again, getting much below, I mean, getting the sub-Q versus an, hour infusion, we're doing research right now to see if there's a difference.
Mayank Mamtani: You may proceed with your question.
Michael Weiss: A number of areas the sub-Q for the IV to sub-Q switch has not been successful.
Mayank Mamtani: Good morning, team.
Michael Weiss: In certain areas it has been successful, so I think we're currently evaluating, but, yes, OOBLEE can be made into a sub-Q.
Eric Joseph: Okay, great.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and enjoy the rest of your day.
Mayank Mamtani: Thanks for taking our question.
Eric Joseph: Thanks for taking the questions.
Eric Joseph: Thanks, Eric.
Matt Kaplan: Our next question comes from the line of Matt Kaplan with Latteberg Salomon.
Matt Kaplan: You may proceed with your question.
Matt Kaplan: Hi, good morning, and thanks for taking the questions.
Matt Kaplan: I guess maybe a question for Adam.
Matt Kaplan: How should we think about
Matt Kaplan: access and especially kind of thinking about it for next year, if approved at the end of December?
Matt Kaplan: How does that access ramp up over the next, for 2023?
Adam Waldman: And how do you drive access?
Adam Waldman: Yeah, thanks for the question, Matt.
Okay.
Adam Waldman: So first and foremost, we've been engaging with payers for over a year at this point. We think early engagement will help in terms of getting coverage as quickly as possible. And those conversations continue to be ongoing.
Adam Waldman: I think in general, they welcome a new entrant into the market.
Yeah.
Adam Waldman: In the CD20 class, they obviously from a overall spend perspective, this is an area of focus for them.
[music].
Adam Waldman: They believe competition has the potential of decreasing overall net costs in the space.
Adam Waldman: And, you know, in general, we think we can get rapid access into 2023 upon approval.
Adam Waldman: You know, everything we've been doing up until this point is aimed at making sure we can get coverage as quickly as we possibly can.
Adam Waldman: Our, you know, big part of that, another aspect of that is making sure that we have a patient support services.
Adam Waldman: We know that that's really important in this space.
Adam Waldman: And we are, you know, well positioned right now.
Adam Waldman: We not only, and back to Ed's question, we have existing infrastructure on patient support that we're able to leverage for this MS launch.
Adam Waldman: We're in good shape in building a best in class patient support services and hub for patients with MS. And we believe that will help with access as well.
Matt Kaplan: Okay, that's very helpful.
Matt Kaplan: And then in terms of driving demand, what's the feedback you've been getting from KOLs, and others in the treatment space in terms of OGLI's differentiated profile?
Adam Waldman: And what do they see as important characteristics that could help to drive demand there?
Adam Waldman: Yeah, I mean, I think first and foremost, it's the one hour infusion.
Adam Waldman: I think that continuously comes up as being an important differentiator. I also think the overall tolerability profile of the drug and the infusion experience overall is something that physicians have noted as being very important.
Adam Waldman: You know, obviously a best ARR that's ever been reported in a phase three study is important.
Adam Waldman: But again, without head to head trials, you know, hard to make the claim that it's better from an efficacy perspective.
Adam Waldman: An ARR is certainly, you know, eye popping or something that at least gets people's attention.
Adam Waldman: And so, you know, overall, I think with the one hour infusion, the efficacy and the safety and tolerability profile, I think it's the whole package that makes it a very compelling and value add, you know, entrant into the market.
Michael Weiss: I'll add on top of that, Matt.
Michael Weiss: I've been on the road personally a lot this summer, meeting, with physicians and other health care providers.
Michael Weiss: And what's interesting to see is that it's not one thing necessarily that gets everyone, but there seems to be for everyone.
Michael Weiss: So as Adam mentioned, you know, we've had people tell us, look, I look at your data and I see, it's one relapse in every 14 years versus one relapse in every seven years for Ocrevus.
Yeah.
Michael Weiss: Why would I use Ocrevus?
Michael Weiss: Present the facts and, you know, quickly we'll find what they're, most interested in.
[music].
Michael Weiss: And as Adam mentioned, sometimes it's the overall tolerability profile.
Michael Weiss: And of course, quite frequently it's the one hour infusion.
Michael Weiss: So just to add on top, again, personal experience out there on the road, we're seeing a lot of good feedback across the board.
Matt Kaplan: All right.
Matt Kaplan: Thanks a lot.
Okay.
Yes.
[music].
Sure.
[music].
Mayank Mamtani: So
Mayank Mamtani: this may be a follow-up on the FDA review discussions.
Mayank Mamtani: Just curious if anything pertaining
Mayank Mamtani: to standard of care differences in the U.S. and maybe the geographies that you may have conducted, I'll admit one and two has, you know, come up.
Mayank Mamtani: And also if you can compare contrast, you know, with the similar three-month delays we've seen with Ocrevus and Kesimta in the past.
Michael Weiss: Yeah.
Michael Weiss: So, I mean, look, you know, the delays that Ocrevus and Kesimta received were also three, months. So their review cycle was pushed back by three months.
Michael Weiss: Ours wasn't.
Michael Weiss: I don't think there's any other way for us to compare.
Michael Weiss: Other than that, Ocrevus specifically said it was a CMC issue.
Michael Weiss: And Kesimta said it was an ordinary review issue or ordinary information request.
Michael Weiss: Other than that, we do not have enough details to try to compare and contrast the two.
Michael Weiss: And in terms of FDA review, again, prepared remarks stated that, you know, we have not heard any follow-up from the specifically related to the request that caused the delay. And we're continuing to work with the FDA in answering their information requests.
Mayank Mamtani: Great.
Okay.
Hi.
Yes.
Okay.
Okay.
Yeah.
[music].
Yeah.
[music].
Uh huh.
Yeah.
[music].
Yeah.
Right.
Right.
Okay.
[music].