Q1 2024 TG Therapeutics Inc Earnings Call
Speaker Change: [music].
Operator: Greetings and welcome to the TG Therapeutics conference call and webcast. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.
Greetings and welcome to the TG Therapeutics conference call and webcast.
At this time all participants are in a listen only mode.
Brief question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Operator: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you, Jenna. You may begin.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Jenna Bosco. Thank you Jenna you may begin.
Jenna Bosco: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco.
Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the first quarter 'twenty 'twenty four financial results are Michael Weiss, our chairman and Chief Executive Officer.
Jenna Bosco: And with me today to discuss the first quarter 2024 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer. Following our Safe Harbor Statement, Mike will provide an overview of our recent corporate developments, Adam will share an update on our commercialization efforts, and Sean will give an overview of our financial results before turning the call over to the operator to begin the Q&A session.
Speaker Change: Adam Waldman, our chief commercialization officer, and Sean power, our Chief Financial Officer.
Speaker Change: Following our safe Harbor statement, Mike will provide an overview of our recent corporate developments Adam will share an update on our commercialization efforts and Sean will give an overview of our financial results.
Speaker Change: Before turning the call over to the operator to begin the Q&A session.
Jenna Bosco: Before we begin, I'd like to remind everyone that we 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 or clinical milestones, revenue guidance, development plans, and expectations for our marketed products. TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated.
Speaker Change: 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.
Mike: These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance projected regulatory or clinical milestone revenue guidance development plans and expectations for our marketed product.
Mike: 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.
Jenna Bosco: Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our SEC filings. 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 later date. We specifically disclaim any obligation to update or revise any forward-looking statement. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. With that said, I'd like to turn the call over to Mike Weiss, our CEO.
Mike: 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 later date.
Mike: We specifically disclaim any obligation to update or revise any forward looking statements.
Mike: 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 with that I'd like to turn the call over to Mike Weiss Our C E O.
Michael S. Weiss: Great. Thanks, Jenna.
Michael S. Weiss: Great. Thanks, Janet and good morning, everyone and thanks for joining us on today's call.
Michael S. Weiss: And good morning, everyone. And thanks for joining us on today's call. 2024 is off to an exciting start, and I'm incredibly proud of the accomplishments already achieved this year. Company-wide, it feels like we are firing on all cylinders. A prime example was the recent announcement of the VA contract for Briumvi as the preferred anti-CD20 for the VA system. We could not be more excited to be able to support our veterans with multiple scholarships by offering Briumvi at a deep discount.
Michael S. Weiss: 2024 is off to an exciting start I'm incredibly proud of the accomplishments already achieved this year.
Michael S. Weiss: Company wide it feels like we are firing on all cylinders are Prime example was the recent announcement of the award of the VA contract ramping as the preferred and think CD 20 for the VA system.
Michael S. Weiss: We cannot be more excited to be able to support our veterans with multiple sclerosis by offering at.
Michael S. Weiss: At a deep discount.
Michael S. Weiss: We see this as a great way to serve our veterans, introduce Brionvi to additional healthcare providers, many of whom split their time between the VA and their academic appointments, and, of course, generate incremental revenue. As for the first quarter, demand for Brionbi was extremely strong, and I'm pleased to report that U.S. Brionbi revenue was in excess of $50 million, and total revenues for the quarter were over $63 million, which includes milestone payments received from our ex-U.S. partner. By any measure, it was a robust revenue quarter for TG.
We see this as a great way to serve our veterans introduced free M. B two additional health care providers, many of whom are split their time between the VA in their academic appointments.
Michael S. Weiss: And of course generate incremental revenue.
Michael S. Weiss: As for the first quarter the demand for beyond meat was extremely strong and I'm pleased to report that the U S revenue was in excess of $50 million in total revenues for the quarter were over $63 million, which includes milestone payments received from our ex U S partner.
Michael S. Weiss: By any measure it was a robust revenue quarter for T J.
Michael S. Weiss: As mentioned previously, starting in late 2023 and continuing, we have significantly increased our investment in patient awareness activities and strategically increased the size of our commercial team. I have to believe these investments contributed to the strong first quarter results. More broadly, our team continues to be focused on our long-term goal of becoming the number one prescribed anti-CD20 from a dynamic market share perspective, and the feedback from physicians, patients, nurses, and infusion centers continues to drive our confidence that that is achievable.
Michael S. Weiss: As mentioned previously starting in late 2023, and continuing we have significantly increased our investment in patient awareness activities and strategically increased the size of our commercial team I have to believe these investments contributed to the strong first quarter results.
More broadly our team continues to be focused on our long term goal of becoming the number one prescribed anti CD 20 from a dynamic market share perspective, and the feedback from physicians patients.
Michael S. Weiss: <unk> says where infusion centers continues to drive our confidence that that is achievable.
Michael S. Weiss: We believe that Briomi has a best-in-class profile that should help us get there. Brionib is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months following the starting dose, and it is the only antibody in phase 3 trials to achieve an annualized relapse rate of less than 0.10. Also, in phase 3 trials, the Brombea one hour infusion was generally well tolerated, with 95% of the one hour infusions being delivered on time.
Michael S. Weiss: We believe that bromine has best in class profile that should help us get there.
Michael S. Weiss: He is the only anti CD 20, a monoclonal antibody.
Michael S. Weiss: It can be given as a one hour infusion every six months following the starting dose.
Michael S. Weiss: The only anti CD 20, monoclonal antibody in phase three trials to achieve an annualized relapse rate of less than one zero.
Michael S. Weiss: Also in phase III trials, the one hour infusion was generally well tolerated with 95% of the one hour infusion being delivered on time.
Michael S. Weiss: Beyond the clinical data, Brionvi is also differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. As previously presented, preclinical data demonstrates that compared to the other anti-CD20s approved or used to treat MS, 3-OMV has the highest binding affinity to CD20, the target found on B-cells, and through its glycoengineering, has the ability to induce the highest level of antibody-dependent cellular cytotoxicity.
Michael S. Weiss: Beyond the clinical data.
Michael S. Weiss: He is also differentiated by design.
Been glycol engineer for enhanced immune effector cell engagement and efficient b cell depletion.
Michael S. Weiss: As previously presented preclinical data demonstrates that compared to the other anti CD 20 is approved we're used to treat en masse.
Michael S. Weiss: The highest by any thing C V 20.
Michael S. Weiss: Targets on the B cells and the routes. We're engineering has the ability to induce the highest level of antibody dependent cellular cytotoxicity.
Michael S. Weiss: We look forward to evaluating these preclinical differences further to assess what, if any, contribution they may have to bring to these differentiated clinical profiles, and we will seek to share these data when available. We're also excited to share during the quarter that there were three newly issued patents by the U.S. Patent and Trademark Office extending patent protection for Brehme through 2042. With the extended runway, our development team is focused on potential expansion opportunities beyond both within MS as well as in other autoimmune diseases. To that end, we are focused on three rearmament-related initiatives this year, which we believe could drive significant future value.
We look forward to evaluating these preclinical differences further to assess what if any contribution then they have to bring all these differentiated clinical profile.
Michael S. Weiss: And we will seek to share these data when available.
Michael S. Weiss: We're also excited to share during the quarter. There were three newly issued patents in the U S patent and trademark office.
Michael S. Weiss: Pending patent protection for <unk> through 'twenty 42.
Michael S. Weiss: With the extended runway our development team is focused on potential expansion opportunities both with M S as well as in other autoimmune diseases.
Michael S. Weiss: To that end, we are focused on three D related initiatives this year, which we believe could drive significant future value.
Michael S. Weiss: First, further improving the convenient dosing of IV drugs. In March, at the Actions Conference, we presented updated data from the Enhanced Trial, evaluating the safety and efficacy of eliminating the 4-hour Brionvi 150 mg starting dose for patients who switch from a prior anti-CD20. Data presented suggests that briomide was well-tolerated for patients that skipped the starting dose. I went straight to the first full 450 milligram dose, giving us a one hour infusion.
Michael S. Weiss: First is further improving the convenient dosing with IV neuropathy in March at the actions conference. We presented updated data from the enhance trial evaluating the safety and efficacy of eliminating the four hour reality of 150 milligram starting dose for patients who switch from a prior Ann.
Speaker Change: Thanks T D 20.
Speaker Change: Data presented suggests that <unk> was well tolerated for patients that skipped the starting dose.
Speaker Change: And went straight to the first full 450 milligram dose given as a one hour infusion.
Speaker Change: Okay.
Michael S. Weiss: These early results are encouraging, and we look forward to continuing to present additional efficacy, safety, and tolerability data from this study throughout the year. Second, the development of subcutaneous Brionbi. We believe the sub-Q CD20 market is distinct from the IVY market and believe this could represent a significant additional opportunity for Brionbi. We are preparing to enter human bioequivalence studies this year and look forward to providing additional updates on this front as we have them throughout the year.
Speaker Change: These early results are encouraging and we look forward to continues to present additional efficacy safety and Tolerability data from this study throughout the year.
Speaker Change: Second is the development of subcutaneous reality.
Speaker Change: We believe the sub Qs T. D 20 market is distinct from the IV market and believe this could represent a significant additional opportunity for real estate.
We are preparing to enter human bioequivalence studies this year and look forward to providing additional updates on this front.
Speaker Change: As we have them throughout the year.
Michael S. Weiss: And third, we look forward to evaluating Brionbi in other autoimmune indications. The goal is to launch our first autoimmune trial evaluating BRI outside of multiple sclerosis later this year. We believe the expansion of ReOMRI represents a significant opportunity and we look forward to providing updates throughout the year, but we're not stopping there. The future of TG also lies in the expansion of our portfolio. We recently entered into a partnership with Precision Biosciences to acquire a worldwide license to Precision's AzerCell and Allogeneic CD19 CART T-cell therapy for autoimmune diseases and all other non-oncology indications. We believe the Acer cell has the potential to be a first-in-class, best-in-class treatment for certain autoimmune diseases, and we look forward to commencing a clinical trial this year.
And third we look forward to evaluating <unk> in <unk>.
Other autoimmune indications.
Speaker Change: Those to launch our first autoimmune trial is the only one.
Speaker Change: When you bring on the outside of the multiple sclerosis later this year.
We believe the expansion of <unk> represents a significant opportunity and we look forward to providing updates throughout the year, but we're not stopping there the future of T. G. Also lies in the expansion of our portfolio. We recently entered into a partnership with precision biosciences to acquire a worldwide license to precision.
Speaker Change: He's yourself and Allergan, a CD 19 car T cell therapy for autoimmune diseases, and all other non oncology indications.
We believe as yourself has the potential to be first in class best in class treatment for certain autoimmune diseases, and we look forward to commencing a clinical trial this year.
Speaker Change: Okay.
Michael S. Weiss: I also want to congratulate our partners at Nurex Farm on their launch of ReArmy in Europe, which also occurred in the first quarter with the first commercial sale in Germany. Transitioning the program to enable their timely launch took significant effort from our team, and I'm proud of how everyone worked so closely together to make it happen. The InterAxFARM team is experienced, motivated, and focused, and we look forward to hearing more from them as the launch progresses to multiple countries across Europe and then around the globe.
Speaker Change: I also want to congratulate our partners at Miramax for them on their launch of <unk> in Europe, which also occurred in the first quarter with the first commercial sale in Germany.
Speaker Change: Transitioning transitioning the program to enable their time to relaunch took significant effort from our team and I'm proud of how everyone who worked so closely together to make it happen.
Speaker Change: The next foreign team is experienced and motivated and focused and we look forward to hearing more from them as the launch progresses to multiple countries across Europe, and then around the globe.
Michael S. Weiss: Finally, I want to thank and acknowledge the entire TG team. It's amazing to see the focus, attention, and care that TGers take to ensure the best possible experience for patients with MS. While we spend a lot of time on these calls talking about numbers, the most gratifying part of my day is hearing firsthand from patients taking Briondi about their positive experiences, as well as HCPs' anecdotes about their patients' treatment successes with Briondi. With that, I will hand the call over to Adam Waldman, our Chief Commercialization Officer, to write a detailed update on the Birmingham U.S. commercial launch Adam, go ahead.
Speaker Change: Finally, I want to thank and acknowledge the entire T. G. T. It's amazing to see the focus the attention and care that teens years take to ensure the best possible experience for them and for patients with them as well.
Speaker Change: You spent a lot of time on these calls talking about numbers. The most gratifying part of my day is hearing firsthand from patients taking beyond the positive experiences.
Speaker Change: As well as H C piece of anecdotes about their patients' treatment successes with reality.
Speaker Change: With that let me hand, the call over to Adam Wallman, Our Chief commercialization officer right a detailed update on the bromine U S commercialization commercial launch Adam go ahead.
Adam Waldman: Thank you, Mike, and good morning, everybody. I'm excited to provide insights into our continued commercial progress in the first quarter. This was another very strong quarter of performance, exceeding our revenue guidance and all of our key performance metrics. Our focus on delivering Brionbi to patients remains unwavering, and I'm pleased to share our progress with you today. In the first quarter of 2024, we continue to see strong uptake of Brium in the market. As reported in our press release, first quarter net sales in the U.S. for BrownBee were $50.5 million, representing 25% growth quarter over quarter.
Adam Waldman: Thank you, Mike and good morning, everybody.
Adam Waldman: I'm excited to provide insights into our continued commercial progress in the first quarter.
Adam Waldman: This was another very strong quarter performance exceeding our revenue guidance and all of our key performance metrics.
Adam Waldman: Our focus on delivering <unk> to patients remains unwavering and I'm pleased to share our progress with you today.
Adam Waldman: In the first quarter of 2024, we continue to see strong uptake in the market.
Adam Waldman: As reported in our press release first quarter net sales in the U S for ground beef were $50 5 million, representing 25% growth quarter over quarter.
Adam Waldman: The first quarter number exceeded our original guidance of 41 to 46 million provided in early January, as well as our updated guidance we provided in late February. The trends we saw early in the quarter continued throughout the quarter, reflecting strong and growing demand for Brium. This growth is particularly impressive given the first quarter challenges associated with the beginning of the year. Pair Dining. In fact, we were the only CD20 and MS to see revenue growth quarter over quarter in the U.S. market during this time period.
Adam Waldman: The first quarter number exceeded our original guidance of 41 to 46 million provided in early January as.
Adam Waldman: As well as our updated guidance we provided in late February.
Adam Waldman: The trends we saw early in the quarter continued throughout the quarter, reflecting strong and growing demand for ground beef.
Adam Waldman: This growth is particularly impressive given the first quarter challenges associated with beginning of the year.
Payer dynamics in fact, we were the only see the 20th en masse to see revenue growth quarter over quarter in the U S market. During this time frame.
Adam Waldman: Equally impressive is that we also saw enrollments grow by approximately 25 percent, with over 1,250 new patient scripts received by the TG Hub in the quarter. I want to congratulate our team on doing an exceptional job preparing for the inherent insurance-related challenges even in the first quarter and mitigating the potential impact. Since launch, we've implemented a comprehensive commercial strategy that encompasses targeted educational initiatives, engaging healthcare providers both virtually and in person, and leveraging digital marketing channels to reach a broader patient audience. Our efforts have resulted in increasing uptake of Brionbi, with healthcare providers recognizing the value Brionbi brings to the patient. Concurrently, ensuring patient access to Briumbe remains a top priority for us.
Adam Waldman: Equally impressive is that we also saw enrollments grow by approximately 25%.
Adam Waldman: With over 250, new patient scripts received by the T D hauled in the quarter.
Adam Waldman: I want to congratulate our team on doing an exceptional job preparing for the inherent insurance related challenges.
Adam Waldman: In the first quarter and mitigating the potential impact.
Adam Waldman: Since launch we've implemented a comprehensive commercial strategy that encompasses targeted educational initiatives engaging health care providers, both virtually and in person and leveraging digital marketing channels to reach a broader patient audience.
Adam Waldman: Our efforts have resulted in increasing uptake of brown b with health care providers, recognizing the value per M. B brings to their patients.
Adam Waldman: Concurrently ensuring patient access to bring up your remains a top priority for us.
Adam Waldman: We continue to receive exceptional feedback on the comprehensive patient support programs we have introduced to assist patients in navigating reimbursement challenges and accessing the treatment they need. We also continue to make significant strides in expanding our market presence. Through targeted marketing initiatives and effective sales force deployment, we've successfully penetrated new accounts and prescribers, driving sustained growth. We saw both an increasing number of repeat prescribers and impressive gains in new prescribers, with approximately 160 new prescribers in the first quarter. The majority of which were from academic centers.
Adam Waldman: We continue to receive exceptional feedback I'm a comprehensive patient support programs, we have introduced to assist patients in navigating reimbursement challenges and.
Adam Waldman: In accessing the treatment they need.
We also continue to make significant strides in expanding our market presence through targeted marketing initiatives and effective sales force deployment, we successfully penetrated new accounts and prescribers driving sustained growth.
Adam Waldman: We saw both increasing number of repeat prescribers and impressive gains in new new prescribers with.
Adam Waldman: With approximately 160, new prescribers in the first quarter, the majority of which were from academic centers.
Adam Waldman: We also continue to convert new centers, adding 65 new accounts in the quarter. To date, we have seen broad adoption of Brionbi across the U.S., with new prescriptions coming from over 450 centers and over 800 unique prescribers. Encouragingly, we also continue to see a diverse mix of patient types, including those that are naive to all treatments and those that were previously treated and switched from both non-CD20 and CD20 agents. This mix of patient types continues to be fairly consistent quarter to quarter with the largest group consisting of patients that were previously treated but naive to anti-CD20 therapy.
Adam Waldman: We also continued to convert new centers, adding 65, new accounts in the quarter.
Adam Waldman: To date, we have seen broad adoption of brown b across the U S with new prescriptions coming from over 450 centers and.
Adam Waldman: And over 800 unique prescribers.
Adam Waldman: Encouragingly Encouragingly, we also continue to see a diverse mix of patient types.
Adam Waldman: Those that are naive to all treatments and those that were previously treated and switch from both non CD 20th ceding 20 agents.
Adam Waldman: This makes the patient types continues to be fairly consistent quarter to quarter.
Adam Waldman: With the largest group group consisting of patients that were previously treated but naive to anti CD 20 therapy.
Adam Waldman: 2024 is off to a really strong start. We achieved record Bramby new patient enrollments into our hub in the first quarter. [inaudible] Despite the first quarter, insurance had; we continue to see momentum building into the second quarter, and based on the information we have available at this time, we are targeting Brembie net revenue of approximately $65 million for the second quarter. In terms of the full year, we continue to feel confident about the Brown Beach trajectory. Based on current trends, we believe we are tracking above the top end of our original guidance of $220 to $260 million and are therefore raising our full year guidance to $270 to $290 million.
Adam Waldman: 'twenty 'twenty four is off to a really strong start we achieve record ramping new patient enrollments since we're a hub in the first quarter.
Adam Waldman: Far exceeded our first quarter revenue guidance and continued to show strong quarter to quarter growth.
Adam Waldman: The first quarter insurance headwinds.
Adam Waldman: We continue to see momentum building into the second quarter and based on the information we have available at this time, we are targeting three M. B net revenue of approximately 65 million for the second quarter.
Adam Waldman: In terms of the well.
Adam Waldman: The full year, we continue to feel confident about the brown b trajectory.
Adam Waldman: Based on current trends, we believe we're tracking tracking above the top end of our original guidance of $220 million to $260 million.
Adam Waldman: We are therefore, raising our full year guidance to $270 million to $290 million.
Adam Waldman: Looking ahead, we see promising opportunities for further growth and expansion. We believe we are poised to broaden our reach and make an even greater impact on the MS patient. We continue to believe Brionbi's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market. In conclusion, I want to thank our team for their dedication and hard work. They have executed the launch plan with precision, driving awareness and adoption among our targeted health care providers.
Adam Waldman: Looking ahead, we see promising opportunities for further growth and expansion.
Adam Waldman: We believe we are poised to broaden our reach and make an even greater impact on the MF patient community.
Adam Waldman: We continue to believe reality profile remains very compelling and will eventually be the IV therapy of choice in the relapsing Ms market.
Adam Waldman: In conclusion I want to thank our team for their dedication and hard work. They have executed the launch plan with precision driving awareness and adoption among our targeted health care providers and we believe their outstanding efforts are contributing to the positive experience with reality and <unk>.
Adam Waldman: And we believe their outstanding efforts are contributing to the positive experience with Brionbi and confidence in our organization. I also want to thank healthcare providers and their patients for their trust in TG Therapeutics. Together, we will continue to improve outcomes for those in need, and we certainly have more work to do, but we are focused and extremely motivated to continue to work every day to bring Briumvi to those people living with MS in their families. With that, I'll turn the call over to Sean Power, our CFO. Sean
Adam Waldman: Confidence in our organization.
Adam Waldman: I also want to thank the health care providers and their patients for their trust and TG therapeutics.
Adam Waldman: Together, we will continue to improve outcomes for those in need and we certainly have more work to do but we are focused and extremely motivated to continue to work every day to bring become reality do those people living with them and their families.
Adam Waldman: With that I'll turn the call over to Sean power, our CFO Shaun.
Sean A. Power: Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed first quarter 2024 financial results, which can be viewed in the investors and media section of our website. This morning, I'll start with a discussion of our revenue. We're pleased to report total revenue of approximately $63.5 million during the first quarter of 2024, which, as previously mentioned, includes $50.5 million of U.S. preempty net product revenue. Also included in our Q124 revenue total is approximately $13 million of license, milestone, royalty, and other revenue, which consists primarily of the $12.5 million milestone we received from our ex-U.S. partner for the first commercial launch of Brionbi in the EU.
Sean A. Power: Thank you Adam and thanks, everyone for joining us.
Sean A. Power: Earlier. This morning, we reported our detailed first quarter of 2024 financial results, which can be viewed on the investors and media section of our website.
Sean A. Power: This morning, I'll start with a discussion of our revenue.
Sean A. Power: We're pleased to report total revenue of approximately $63 5 million during the first quarter of 'twenty 'twenty four which as previously mentioned includes $55 million of U S. M D net product revenue.
Sean A. Power: Also included in our Q1 'twenty for revenue total is approximately $13 million of license milestone royalty and other revenue.
Sean A. Power: Which consists primarily of the 12 and a half about 12 and a half million dollar milestone we received from our ex U S partner for the first commercial launch of reality in the EU.
Sean A. Power: Our OPEX during the first quarter of 24, despite some one-time charges, remained well controlled and in line with previously discussed ranges. For the first quarter of 24, our operating expenses were approximately $58 million, which included one-time charges for research and development expenses of approximately $8.8 million related to our agreement with Precision Biosciences for the in-licensed ASER cell program. During the first quarter of 24, we also saw a modest increase in R&D expenses driven by manufacturing and development costs associated with our Oobletoximab subcutaneous development work.
Sean A. Power: Our opex during the first quarter of 24.
Sean A. Power: Some one time charges has remained well controlled and in line with previously discussed ranges.
Sean A. Power: For the first quarter of 'twenty for our operating expenses were approximately $58 million, which includes one time charges to research and development expenses of approximately $8 8 million related to our agreement with precision biosciences for the in license either sell program.
Sean A. Power: During the first quarter of 'twenty four we also saw a modest increase in R&D expenses, driven by manufacturing and development costs associated with our Uber talk to my subcutaneous development work.
Sean A. Power: On the back of the reported revenues and well-controlled OPEX, during the first quarter of 24, we reported a modest net loss of approximately $10.7 million, or $0.07 per share, compared to a net loss of approximately $39.2 million, or $0.28 per share, during the comparable quarter in 2023. From a cash standpoint, we ended the first quarter with $209.8 million in cash, cash equivalents, and investment securities, down less than 10 million from Q4 of 23.
Sean A. Power: On the back of the reported revenues and well controlled opex during the first quarter of 'twenty four reported a modest net loss of approximately $10 7 million or seven cents per share.
Sean A. Power: Compared to a net loss of approximately $39 2 million or 28 cents per share during the comparable quarter.
Sean A. Power: In 2023.
Sean A. Power: From a cash standpoint, we ended the first quarter with $209 8 million in cash cash equivalents and investment securities.
Sean A. Power: Down less than 10 million from Q4 of 'twenty three.
Sean A. Power: We believe our current cash position, coupled with our previously guided revenue and expense guidance, provides us with sufficient capital to fund our operations to cash flow positivity. With that, I will now turn the call over to the conference operator to begin the Q&A.
Sean A. Power: We believe our current cash position coupled with our previously guided revenue and expense guidance provides us with sufficient capital to fund our operations to cash flow positivity.
Speaker Change: With that I will now turn the call over to the conference operator to begin the Q&A.
Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we pull for questions. Thank you. Our first question comes from the line of Michael DiFiore with Evercore. Please proceed with your question.
Speaker Change: Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: Information to only indicate that your line is in the question queue.
Speaker Change: And you May press star two if he would like to remove your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: One moment, please while we poll for questions.
Speaker Change: Thank you. Our first question comes from the line of Michael D. Fiori with Evercore. Please proceed with your question.
Michael Gennaro DiFiore: Hi, good morning guys. Thanks so much for taking my question and congratulations on all the great progress this quarter. I have two questions. Regarding sales in the EU, I know it's very early, but when can we expect Nurex Farm to begin offering details? And I have two follow-ups. Thank you.
Speaker Change: Hi, Good morning, guys. Thanks, so much for taking my question and congrats on all the great progress this quarter a couple from me regarding sales in EU I know, it's very early but when could we expect nor ex farm to begin offering details and I have two follow ups. Thank you.
Michael S. Weiss: Yeah, so in terms of Nurex providing public details, I think we're a long way off. They're a private company, private equity backed, so I don't anticipate they'll be providing any public guidance or information, to my knowledge. Adam, anything different from your side?
Speaker Change: Yeah. So in terms of nearer term, providing public details I think we're a long way off there are private companies private equity back.
Speaker Change: So I don't anticipate they'll be providing any public.
Speaker Change: Guidance or information to my knowledge, Adam anything different from your side.
Adam Waldman: No, no, I have nothing to add there.
Speaker Change: No no nothing either.
Michael Gennaro DiFiore: Okay, okay, fair enough. And my other two questions are, how much of Bramby's fiscal year 24 guidance increase was due to the recently announced VA contract? And any color that you could provide on pricing or increased rebates in this segment? I know you said it's heavily discounted.
Speaker Change: Oh, Okay, Okay fair enough.
Speaker Change: The two questions are how much of <unk> fiscal year 'twenty four guidance raise was due to the recently announced VA contract and any color that you can provide on.
Speaker Change: Pricing or increased Rebating in the segment I know you said, it's heavily discounted.
Adam Waldman: Yeah, Adam, go ahead.
Speaker Change: Yeah go ahead.
Speaker Change: Sure Yeah. The revenue raised was really the VA was not really factored in for a couple of reasons one.
Adam Waldman: Sure, yeah, the revenue raise was really, the VA was not really factored in for a couple reasons. One, you know, this won't go into effect until June. Second, it will be a gradual, you know, sort of increase as new patients get on. Patients will only really have the opportunity this year to have, you know, their first two infusions at best.
Speaker Change: You know this won't go into effect until June our second it'll be a gradual.
Speaker Change: Increases as new patients get on <unk>.
Speaker Change: Patients will only really have the opportunity in this year to have the first two infusion at best.
Michael Gennaro DiFiore: So it'll be a gradual increase, and it wasn't really a factor in the way that we looked at raising our guidance. The guidance was raised based on the demand trends that we're seeing. As far as pricing is concerned, I think that's out there and public. We offered about a 72% discount. Roughly about 2,900 vials.
Speaker Change: So it'll be a gradual increase and it wasn't really a factor in the way that we've looked at raising our guidance. The guidance was raised based on the demand trends that we're seeing.
Speaker Change: First pricing I think that's out there in public we offered to about 72% discount.
Speaker Change: Roughly about 2900 a vial.
Speaker Change: Okay.
Michael Gennaro DiFiore: Great. And my last question is this:
Speaker Change: Great and my last question is is this and the most recent cut of the enhanced data presented at <unk> three.
Michael S. Weiss: In the most recent cut of the enhanced data presented at ECTRIMS, three patients in Cohort 2 had to have their infusions slowed down or interrupted. Any color on these patients? Like how long were these infusions slowed down to or interrupted for? And were there any unique clinical features of these patients that could explain that?
Speaker Change: Three patients in cohort two have to have their infusion slowed down or interrupted.
Speaker Change: Any color on these patients like how long would these infusion slowed down too or interrupted for.
Speaker Change: And were there any unique clinical features of these patients that they could explain this.
Speaker Change:
Michael S. Weiss: So, no, I don't think there was anything particular about the patients, but the effusions flowed were pretty modest, and I think all were done reasonably close to one hour anyway. So, no, I think it was just, you know, basic stuff that was typical of infusions, but I don't think there's anything to be worried about there. It was well-tolerated overall, and those patients, too, did well.
Speaker Change: So no I don't think there was anything particular about the patients, but the the infusion. So we're pretty modest and I think all we're done.
Speaker Change: Close to the the one hour anyway.
Speaker Change: So no I think it was just.
Speaker Change: Basic stuff.
Speaker Change: Typical of infusions, but.
Speaker Change: I don't think there's anything to be worried about there.
Speaker Change: Well tolerated overall and those patients that did well.
Speaker Change: Got it thanks, so much.
Michael Gennaro DiFiore: Got it. Thanks so much. Congratulations again.
Speaker Change: Congrats again.
Speaker Change: Yes.
Speaker Change: Okay.
Operator: Our next question comes from the line of Ed White with H.C. Wainwright. Please proceed with your question. Good morning.
Speaker Change: Our next question comes from the line of Ed White with H C. Wainwright. Please proceed with your question.
Edward Patrick White: Good morning. Congratulations on the results and thanks for taking my question.
Edward Patrick White: Good morning, congratulations on the results and thanks for taking my questions.
Edward Patrick White: So just to clarify what you just said on the VA contract, Adam. Was it a 72% discount? Yes. Okay, thank you. This has been brought up before, but I just wanted to address it again, thinking about the potential opportunity, you know, in the so-called Crap Gap with OkraVis. Is this something that you think you'll be able to produce data on or, you know, somehow address this with your sales force?
Edward Patrick White: Hmm.
Edward Patrick White: So just to clarify what you just said on the VA contract Adam was at a 72% discount.
Edward Patrick White: Okay.
Edward Patrick White: Yes.
Speaker Change: Okay. Thank you.
Edward Patrick White: And you know.
Edward Patrick White: This has been brought up before but I just wanted to address it again I'm thinking about the potential opportunity.
Edward Patrick White: You know in the so called crap gap with with OCA. This is this something that you think you'll be able to produce data on or.
Edward Patrick White: Somehow address this with your sales force.
Speaker Change: Yeah. So.
Michael S. Weiss: Yeah, so in terms of Crab Gap and being able to show it, I mean, we're trying to capture as much data as we can through the Enhanced Study. I think the number is about 60 to... 60-ish percent, maybe a third, two-thirds, report crab gap as they're coming into the enhanced trial. So we'll try to capture some of that information on the back end. Hopefully, we'll have at least some anecdotal information about the patient reported, whether they are or are not seeing a crop gap.
Speaker Change: In terms of crab cap in and being able to show it I mean, well, we're trying to capture as much data as we can through enhanced.
Speaker Change: Enhanced study.
Speaker Change: I think the number was about 60 D C.
Speaker Change: 60 ish percent, maybe a third two thirds Ah report cross got as they're coming into the enhance trial. So we're trying to capture some of that information on the backend and hopefully we'll have at least some anecdotal information about that patient reported whether they're on or.
Speaker Change: <unk> not seen any crop yet it's hard and there's no there's no scale.
Michael S. Weiss: It's hard, there's no scale to objectively measure the crop gap. There's no, So it is a challenging thing to measure, but we'll do the best we can within the enhanced study and whatever studies we conduct, we will certainly try to parse out the effect and whether we've changed that for patients.
Speaker Change: To objectively measure crap can't there's no.
Speaker Change: So it is a challenging thing to measure, but we'll do the best we can with an enhanced studying and whatever studies and conduct we are we will certainly try to parse out a bit.
Speaker Change: Fact, and whether we've changed out for patients.
Edward Patrick White: Okay, thanks, Mike. And just when thinking about other potential indications... How do you prioritize them outside of MS? You know, I'm sure you have plenty of factors in there, but where does, you know, time to potential approval come in or size of the potential market come in? How are you sort of ranking that?
Speaker Change: Okay, Thanks, Mike and just.
Speaker Change: When thinking about other potential indications.
Speaker Change: How do you prioritize outside of M S.
Michael S. Weiss: I'm sure you have plenty of factors in there, but where does you know time to potential approval come in.
Speaker Change: Or size of the potential market, how are you sort of ranking that.
Michael S. Weiss: Yeah, I mean, look, we're probably focused on things like RA and lupus for Brionvi outside of MMS, sort of larger indications. And as we've said previously, in some more niche indications, we would be looking at azure cells.
Michael S. Weiss: Yeah, I mean, I think look where we're probably focused on things like our a M best for for being on the outside of it and that's sort.
Michael S. Weiss: So the larger indications.
Speaker Change: And as we've said previously and some more.
Speaker Change: Niche indications, we would be looking at it as yourself.
Edward Patrick White: Okay, Mike, thanks for taking my question.
Speaker Change: Okay, Mike Thanks for taking my questions.
Michael S. Weiss: Thanks, Ed.
Operator: Our next question comes from the line of Roger Song with Jeffreys. Please proceed with your question.
Michael S. Weiss: Our next question comes from the line of Roger song with Jefferies. Please proceed with your question.
Roger Song: Great, and my congratulations on the 1Q results. And then, so, just a couple of questions from us. One is, understanding that your hub is capturing mostly new patients, and given you have quite a few quarters since launch, so how would you characterize the repeat infusion rate you have been seeing?
Roger Song: Great and my congrats to you are the one cure without.
Roger Song: And then so just a couple of questions on us.
Roger Song: One is understanding Youre hot is capturing most of the day the new patients are in that given you have a quite a few quarters since launch.
Roger Song: How would you characterize the repeat infusion rate you had been.
Roger Song: Okay.
Adam Waldman: Yeah, Adam. Do you want to go ahead on that one?
Speaker Change: Yeah, I'm going to go ahead on that one.
Adam Waldman: Yeah, so yes, just to reconfirm here: the patient hub numbers that we're giving you are for new patients only. So just to do I think that was your question there, and then as far as persistence, we would say we're still early in the process with our data and we continue, but however, the data that we see, we continue to see that the 24-week persistence is in line or maybe slightly better than our expectations of about 85% week 24. So we feel pretty good about it, although the data is early. We'll continue to look at it, but right now, it's in line with or maybe slightly ahead of what we expected.
Speaker Change: Yeah. So yes, just to reconfirm here the patient hub numbers that we're giving you our new patients only.
Speaker Change: So just to do I think that was your question there and then as far as persistence.
Speaker Change: We would say we're still we're still early in the.
Speaker Change: You know with our data and we continue but however, with the data that we see we continue to see that the 24 week persistence is in line or or or maybe slightly better than our expectations of about 85%.
Speaker Change: A week 24.
Speaker Change: So.
Speaker Change: We feel pretty good about it although the data is early.
Speaker Change: We will continue to look at it but right now it's in line or maybe slightly ahead of what we what we expected.
Speaker Change: Okay.
Speaker Change: Yeah.
Roger Song: Excellent. Thank you. Eighty-five percent. That's good. And then, so... You have now 800 health providers at around 450 centers, so understanding where you start to, you know, when you plan the launch, you are targeting top 550 accounts covering 70 to 80 percent of the MS patients. I'm just curious, is that still the goal for the provider or the center outreach, and then if that's still the case, then when do you expect you will achieve that 550 from the 450?
Speaker Change: Excellent. Thank you, 85% and that's good.
Speaker Change: And then so.
Speaker Change: You are having now.
Speaker Change: 800 health provider at all.
Speaker Change: What is the key sensors, so understanding where you'd stop sure you know we intend to launch in Europe targeting pumps.
Speaker Change: So covering 70 to 80 per cent of an M. S. Patient just curious is that skewed that the goal for the provider or the center outreach and Dan If that's still the case and when do you expect you will achieve that 550 found that 450.
Speaker Change: Yeah Yeah.
Adam Waldman: Yeah, so I think if I understand the question, it's, what's our goal in terms of new accounts and new prescribers? I'll just say that I think we've done really well. We've got broad adoption right now, but we certainly see opportunity for more adoption with even more prescribers and, of course, deepening the use with our current prescribers. The good news this quarter is that we saw increases in both repeat prescribers and adding new prescribers at a pretty good clip and new accounts at a pretty good clip. So we feel good about it. We'll continue to make progress every day and certainly have opportunities, but we feel good about where we're at right now.
Speaker Change: Yeah. So I think I think if I understand the question is whats our goal in terms of new accounts and new prescribers I'll, just say that I think we've done a really good we've got broad adoption right now, but we certainly see opportunity for more adoption with a even more prescribers and of course.
Speaker Change: Deepening the us with our current prescribers.
Speaker Change: The good news in the quarter as we saw increases in both repeat prescribers and adding.
Speaker Change: New prescribers that are at a pretty good clip and in new accounts at a pretty good clip. So we feel good about it we'll continue to make progress every day and certainly have opportunity.
Speaker Change: But feel good about where we're at right now.
Roger Song: Great, thank you. One last question related to the financials. So, I think earlier this year you were guiding the op-ed to 250 for the year. I just want to confirm if that's still the guidance for now, and then also curious about the expectations for the coming years, given your continued commitment to launch and expanding your pipeline. Thank you.
Speaker Change: Great. Thank you one last question relates to the financials.
Speaker Change: So I think earlier this year, you're guiding Opex is 250 <unk> for the year I just wanted to confirm if that's still the guidance for now and then also curious about the.
Speaker Change: The accident for the coming years, given your continued shoe launch and extending your pipeline. Thank you.
Michael S. Weiss: Yeah, I'll take a first crack and Sean can jump in. But yeah, I mean, I think we're well on track to set approximately 250 in OPEX, so it gives us a little wiggle room there. But if you look at even the first quarter, we had 58 and change and we had eight and change, which was that one time to precision. So the base OPEX is still only around 50 for the quarter. So if you multiply that times four, you're still well under 250.
Speaker Change: Yeah.
Speaker Change: I'll take a first crack and Shawn jump in AR.
Speaker Change: But yeah, I mean, I think we're well on track.
Speaker Change: To me, we said approximately 250 in opex or give us a little wiggle room there.
Speaker Change: But if you look at even the first quarter.
Speaker Change: We had a 58 and change and we had eight and change which was that one time two to precision. So the base Opex is still only around 50.
Speaker Change: For the quarter.
Speaker Change: So you multiply that times, four you're still well under the 215.
Sean A. Power: That gives us room to grow, and we are growing. Like I said in my prepared remarks, we're strategically adding to our team, and we're continuing to spend money on patient awareness programs. But I think, you know, from where we sit today, we're in pretty good shape. Sean, any more details there? Yeah, I think you should.
Speaker Change: That gives us room to grow and we are growing like I said in my prepared remarks, we're strategically adding to our IR team.
Speaker Change: We are continuing to spend money on patient awareness programs.
Speaker Change: I think you know from where we sit today, we're in pretty good shape.
Speaker Change: Sean I mean any more details there.
Sean A. Power: No, I think you covered it pretty well.
Sean A. Power: No I think here I think he covered it pretty well.
Speaker Change: Okay.
Roger Song: Great, thank you. That's it for all of us.
Sean A. Power: But I think that's up on that.
Roger Song: Roger our next.
Operator: Our next question comes from the line of Matt Kaplan with Lattenberg Thalman. Please proceed with your question.
Roger Song: Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Matthew Lee Kaplan: Hey, good morning, guys. Unknown Speaker, congratulations on the quarter. So maybe for Adam, in terms of new patient starts, can you give us a little bit more detail in terms of where they're coming from in terms of Naive, Switch, and the background from which you get these new patients?
Matthew Lee Kaplan: Hey, good morning, guys.
Matthew Lee Kaplan: Hum.
Matthew Lee Kaplan: Congrats on the quarter.
Matthew Lee Kaplan: So maybe for Adam in terms of new patient starts can you give us a little bit more detail in terms of where they're coming from in terms of naive switch and are in the background.
Speaker Change: But you're getting some questions on.
Adam Waldman: Yeah, thanks, Matt. Good morning.
Adam: Yeah. Thanks, Matt Good morning, So I would say you know we have not given out specific percentages of the other piece of it and how it exactly breaks out what we said is.
Adam Waldman: So, I would say, you know, we have not given out specific percentages of patients and how it exactly breaks out. What we said was the biggest group is patients switching from non-CD20s, but we also have good representation from treatment-naive patients as well as patients that are switching from CD20s like Ocrevus or Kesimpta. So, we're getting, encouragingly, we think we're getting a nice diverse group of patients and, importantly, you know, staying consistent quarter to quarter. There weren't any, you know, sort of big, you know, boluses of a certain patient group that sort of diffused over time. So, we're seeing consistent representation from all three of those groups.
Adam: The biggest group is patient switching from non P D twenties.
Adam: But we also have good representation from treatment treatment naive patients as well as Ah patients that are switching from from CD twenty's like OCA risks or cause some to so we're getting a encouragingly. We think we're getting a nice diverse group of patients and importantly, staying.
Adam: And quarter to quarter, there's no. There's there wasn't any sort of big bolus is of a certain patient group that that sort of diffused over time. So we're seeing consistently representation from all three of those groups.
Speaker Change: Okay. That's helpful. Thanks, and then I guess in terms of the subcutaneous opportunity for Greyhound formulation I guess recently on the on the Roche call. They said they see the that the subcutaneous opportunity is that's more than $2 billion.
Matthew Lee Kaplan: And then, I guess, in terms of the subcutaneous opportunity for the Bramby formulation, I guess recently on the Roche call, they said they saw the subcutaneous opportunity as more than $2 billion. I guess the question is, with your potential differentiated profile, what's your assessment of the sub-Q opportunity? Yeah, I'll...
Speaker Change: Yes question is with with your potential differentiation differentiated profile on what what what's your assessment of the opportunity.
Michael S. Weiss: Yeah, I'll speak broadly, and I'll let Adam chime in. I mean, look, the folks at Novartis have done a really nice job of carving out a sub-Q market. They created it, and I think, as Roger probably mentioned, Novartis is probably over $2 billion and growing today. So there's a nice market there, and yeah, I mean, our goal is to come into that market with a very competitive profile product. As we've said previously, we understand the parameters.
Speaker Change: Yeah.
Speaker Change: It broadly and I'll, let Adam chime in.
Adam: But the the.
Adam: Folks at at Novartis have done a really nice job of carving out a sub to market. They created it and I think as Raj probably mentioned in Novartis is probably over $2 billion and growing today.
Adam: So there's a there's a nice market there and yeah. I mean, our goal is to come into that market with a very competitive profile product as we've said previously we we understand the parameters we've got one handy.
Michael S. Weiss: We've got, on the one hand, a relatively elegant auto-injector once a month, and you've got a relatively bulky product every six months. Somewhere in the middle, we think, is an optimal product design, and we're going to try to get there. So I think from just where we sit today, we see an opportunity, and we're going to take our best crack at it.
Adam:
Adam: Relatively elegant a auto injector in one sense once a month and you've got a relatively bulky.
Adam: <unk> product every six months.
Adam: Somewhere in the Middle we think is an optimal product design and we're going to.
Adam: Try to get there so yeah I think from just.
Adam: Where we sit today, where we see an opportunity.
Adam: Take our best crack at it.
Adam:
Adam: Yeah.
Adam Waldman: Nothing else to really add there, Mike.
Speaker Change: Nothing else to really add there Mike.
Matthew Lee Kaplan: Sorry, sorry about that. All right. Thanks.
Speaker Change: Sorry, sorry about that.
Matthew Lee Kaplan: Alright, thanks for taking the questions, guys.
Michael S. Weiss: All right. Thanks, Thanks for taking the question guys.
Speaker Change: Yeah.
Adam: Okay.
Adam: Yeah.
Operator: Our next question comes from the line of Mayank Mamtani with B. Reilly Securities. Please proceed with your question. Good morning.
Speaker Change: Our next question comes from the line of my Young Man Tani with.
Speaker Change: B Riley Securities. Please proceed with your question.
Speaker Change: Good morning team congrats on a strong quarter and thanks for taking our questions.
Mayank Mamtani: Good morning team, congrats on a strong quarter and thanks for taking our questions. Sorry Adam if I missed this, did you say the revenue split up between new patient stacks and maintenance patients and I was also curious to hear from you how you think you know that stacking up effect in second half, you know how we should expect that revenue split to be and if you can also comment on you know some other metrics you've provided before, free drug percentage, close to net, anything on that would be helpful as we think about the full year modeling and then I have a couple of follow-up.
Speaker Change: Sorry, I didn't if I missed this did you say the revenue split though.
Speaker Change: New patient starts and maintain and stations and I was also curious to hear from you. How you think that stacking effect in second half.
Speaker Change: You know, how we should expect that revenue split to be in and if you've got an also Colin Dunn.
Speaker Change: Some of the metrics you provided before feed reservoir sand days gross to net and anything on that would be helpful. As we think about the full year modeling and then I have a couple of follow up.
Adam Waldman: Yeah, we didn't share, so you didn't miss it. We didn't share any specifics on new versus continuing patients from a revenue perspective. We do continue to feel that, you know, this is a market where duration is a big driver of revenue, and there will be a pancaking effect that will, as time goes on, patients will stick with this very sticky, the duration is really good. Patients are on the drug for an average of five years. So you will see that pancake-like effect over time.
Speaker Change: Yeah, we didn't we didn't.
Speaker Change: Sure you didn't miss it we didn't share any specifics on new versus continuing patients from a revenue perspective, we.
Speaker Change: We do continue to feel that you know this is this is a market where duration is a big driver of revenue and there will be a pancaking effect that will.
Speaker Change: As time goes on you know patients will well. This is a very sticky the duration is really good patients on drug an average of five years or.
Speaker Change: So you will see that pancake effect over time.
Speaker Change: So that's that's the best that I have for that question I think your other questions was free drug.
Adam Waldman: So that's the best that I have for that question. I think your other question was about free drugs. As I've said before, we did expect the free drug rates to come down. We are seeing the free drug rates come down. I think in the first quarter, we're about 12%. Right now, I think it's about 12% from earlier in 2023, we're about 20%. So 12% in the quarter. And then from a gross net standpoint, I think what we said previously is that our gross net is approximately 75%. We'll go up and down from quarter to quarter, but 75% is probably a good number to use for the remainder of 2024.
Speaker Change: As I've said before we did expect a free drug rates to come down we are seeing for drug rates come down I think in the first quarter were about 12%.
Speaker Change: Is are right now I think it was about 12% from earlier in 2023, we're about 40%.
Speaker Change: So 12% in the quarter and then from a gross to net standpoint.
Speaker Change: I think what we said previously is our gross to net is approximately 75%.
Speaker Change: We will go up and down from quarter to quarter, but 75% is probably a good number to use for the for the remainder of 2024.
Mayank Mamtani: Thank you, that's helpful. And then in your updated guidance for the full year, I was just curious to learn, you know, how you think about that year-end exit market share? Again, like, I don't know if you think of the market as a total NRX percentage, which, Mike, I think you provided, you're tracking at that 10%. But obviously, curious to hear how you think about that market share in terms of either total RMS patients or within the anti-CD20 drug class patients. Could you just give us some color on how what that 280 million midpoint assumes in terms of market share?
Speaker Change: Thank you that's helpful and then in your updated guidance for.
Speaker Change: For the full year.
Speaker Change: I was just curious to learn.
Speaker Change: How are you thinking about that year end exit market share.
Speaker Change: Again like I don't know if you think of the market.
Speaker Change: So the in our X percent, David It's Mike I think you've provided you're tracking at that 10%, but obviously curious to hear how.
Speaker Change: You'd think about that market share in terms of either total RMS stations are within the <unk> drug class.
Speaker Change: Basically like could you just give us some color on how what would that do 80 million midpoint assumes in terms of market share.
Adam Waldman: Yeah, Mayank, I'm probably not going to get into any specifics. I mean, our goal here is to increase the depth of the use and the breadth of the use and continue to add new prescribers. We see continued opportunity for growth, and we feel very confident in the trajectory. We feel very confident in the demand trends that we're seeing, and we're going to continue to focus on growing the usage of BriumV across the market. And we're doing a great job of it. And, you know, based on our guidance here, we obviously feel very confident in continued growth going forward.
David: Yeah, Mike I'm, probably not going to get into any specifics I mean, our our our goal here is to increase the depth of the use and the breadth of the use and and continue to add new prescribers. We see continued opportunity for growth, we feel really very confident in the trajectory we see value.
David: Very confident in the demand trends that we're seeing.
David: And we're going to continue to focus on growing the usage of our brand and be you know across the market.
Speaker Change: And we're doing a great job of it and you know based on our guidance here, we feel obviously feel very confident in continued growth going forward.
Michael S. Weiss: I'm just going to chime in on the first question you asked about the revenue split, new versus old. I know we're not providing actual numbers, but I think it's worth just to mention that in the early years, you know, we're going to be driven by the new starts, and the later years will be driven by the ongoing or stacking patients. So if you look at our competitive IV, CD20 has been on the market for a long time.
Speaker Change: Okay, Yeah, my own kind of I know Glenn you got good.
Glenn: Yeah, I'm, just going to chime in on the on the first question you asked about the revenue split new versus old.
Glenn: Just I know, we're not providing actual numbers, but I think it's worth just to mention that in the early years.
Glenn: So we're gonna be driven by the new starts in the later years will be driven by the AR and the ongoing or stacking patients.
Glenn: So if you look at probably our competitive Oh.
Glenn: I V C V twin who's been on the market for a long time, the vast majority of their sales are going to be based on a continuum of patients not on new patients in any particular quarter, whereas I'd say, we're probably the opposite still right. We're still reliant on new starts.
Michael S. Weiss: The vast majority of their sales are going to be based on continuing patients, not on new patients in any particular quarter, whereas I'd say we're probably the opposite still, right? We're still reliant on our new starts, but over time, the continuing patients sort of take the commanding role in how the revenue stacks up.
Glenn: But over time.
Glenn: The patients sort of take the commanding roll in and how the revenue step up.
Speaker Change: Yes, and that bodes well for that.
Mayank Mamtani: Yeah, and that bodes well for that, you know, size of that pancake downstream. Yeah, I guess last question, last question on the sub-Q target product profile, Mike, just, you know, would be helpful to understand how you and, you know, even some of the KOL feedback now that we know what the sub-Q profile for Ocrevus would look like at launch now that we have all the data out there. We're just curious, Mike, as you design the human bioequivalence study, what differentiating attributes are in mind as you think about that product profile?
Glenn: Isn't that bad cake.
Glenn: Downstream Yeah, I guess last question last question on the South <unk> target product profile, Mike just I'm.
Glenn: But it would be helpful to understand how you and even so they gave us feedback.
Glenn: Now that we know what the sub Q profile, Florida, Oklahoma. This would look like at launch.
Glenn: Now that you know all of the data is out there as well just curious Mike as you desire and need human Bioequivalence study what differentiating attributes are in mind as you think about that product profile. Thanks.
Michael S. Weiss: And thanks again for the
Speaker Change: Thanks again for taking my question.
Mayank Mamtani: Yeah, so I mean, look, the Ocrevus sub 2 is not a true patient-administered at-home product today. So that is yet to be created, or not created, but to be... or even studied, as far as my knowledge is concerned. So that's still yet to come. I mean, our goal is to have something that is a patient-administered, patient-friendly product. Again, more along the lines of what was done with Ofatunemab. So, I don't know how much more I could say other than we think there's a lot of room to thread the needle here and come up with a product profile that accomplishes the goals of being both convenient and easy to use.
Michael S. Weiss: Yeah, So I mean look.
Michael S. Weiss: The the OCA vis sub Q.
Speaker Change: There's not a true yeah.
Speaker Change: Patient administered at home product today.
Speaker Change: So that is yet to be created or not created but to be oh available or even studies as far as my knowledge.
Speaker Change: No.
Speaker Change: That's still yet to come and our goal is to have something that is a patient administered patient friendly product again more along the lines of of what.
Speaker Change: It was done with them.
Speaker Change: Sure Matt So yeah.
Speaker Change: I don't know how much market share and then you know we think there is a lot of room to to to thread the needle here and come up with a product profile.
Matthew Lee Kaplan: That accomplishes the goals of being both convenient.
Matthew Lee Kaplan: And easy to use.
Michael S. Weiss: Got it. Look forward to some of those updates. Thanks, Mayank.
Matthew Lee Kaplan: Got it and look forward to some of those updates.
Michael S. Weiss: This is Mike.
Speaker Change: Thank you.
Michael S. Weiss: Yeah.
Operator: Our next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your question.
Michael S. Weiss: Our next question comes from the line of Paccar, Idaho, Idaho, while with Cantor Fitzgerald. Please proceed with your question.
Prakhar Agrawal: Hi, good morning, and thanks for taking my question and congrats on the quarter. So just following up on the subcute pre-MV question, I'm trying to better understand what your base case assumption is on where the dosing frequency could land for subcute pre-MV. I guess the reason I'm asking is if it ends up being once a month, would you still go ahead with the subcute development? And I had one more.
Paccar: Hi, Good morning, Thanks for taking my question and congrats on the quarter. So just falling up on the subdued bring big question.
Paccar: I'm trying to better understand like what's your base case.
Paccar: On where the dosing frequency could land for substitute B M. B I guess the reason I'm asking is if it ends up being once a month would you still go ahead with the substitute development and I had one more.
Michael S. Weiss: Yeah, I mean, I think the bottom line is that we probably would, but I don't think that's going to be necessary. So I don't know that that's the scenario that it is.
Speaker Change: Yeah, I mean, I think the bottom line is.
Speaker Change: We probably will but I don't think that's going to be necessary. So I don't know that that's a scenario that that is yeah.
Michael S. Weiss: Likely, but yeah, I mean it's early to tell, and again, I think if we feel like we've got something that has a good opportunity to make a dent in the market, we'll go forward, and you know, certainly once a month could have some impact on the market. Obviously, probably less impact than something that has a shorter duration. We'll do the math on that and not less duration, but less frequency, but I'm not so concerned with that as an issue.
Speaker Change: Likely but yeah I mean, it's early to tell them and again I think if we feel like we've got something that has a good opportunity to make a dent in the market will go forward and you know certainly a once a month it could be a could have some impact in the market and obviously probably has less impact.
Speaker Change: Something that has a less duration and we'll do the math on that.
Speaker Change: So that's frequency, but I'm I'm not so concerned that that's an issue here.
Speaker Change: Okay.
Prakhar Agrawal: And when do we expect patients to be dosed for subcured pre-work?
Speaker Change: And when do you expect patients to be dosed four subdued briefly.
Speaker Change: Hum.
Michael S. Weiss: We hope to have the first patient's dose within the first half of this year, so hopefully in the next few months.
Speaker Change: We would hope to have the first patient dose within the first half of this year. So hopefully in the next few months here.
Speaker Change: Got it and lastly from my side, we've seen a lot of data on CD 19 antibodies and other autoimmune indications. What's your view on CD 19 worse. Its 80 20, and obviously there was a theory that targeting CD 19 could achieve broad coverage of the BC parkman compared to lets say its 80 20.
Prakhar Agrawal: And lastly, from my side, we're seeing a lot of data on CD19 antibodies and other autoimmune indications. What's your view on CD19 versus CD20? And obviously, there's a theory that targeting CD19 could achieve broader coverage of the B-cell compartment compared to, let's say, CD20. So, just wanted to get your perspective there. Do you have a CD19 antibody in the early stage pipeline
Speaker Change: So just wanted to get your perspective, there and do you have a CD 19 in early stage pipeline.
Michael S. Weiss: So yeah, I mean, we do have a CD-19, and our Azercell CAR-T therapy is a CD-19. So we think CD-19 is a great target, we think it... It's hard to know if the broader coverage is positive in all settings.
Speaker Change: So yeah I mean, we do have a CD 19, that's are either sell a car T therapy is exceeding 19. So we think CD 19 news is a great target.
Speaker Change: We think it.
Speaker Change: It's hard to know if the the broader coverage as a positive in all settings are there are some diseases that are characterized by a plasma cells that may be impacted by sitting room team or maybe expressing <unk> 19, where that may be helpful.
Michael S. Weiss: There are some diseases that are characterized by plasma cells that may be impacted by CD19 or may be expressing CD19 where that may be helpful. NMO is one that folks talk about quite frequently as potentially CD19 driven. So we think there are areas where CD19 may be helpful, but overall, we think the overlap between CD20 and CD19 is going to be hard to distinguish in most diseases. And while CD19 hits pre-B cells in addition to B cells, CD20 only hits mature B cells.
Speaker Change: The animal was one that that folks talk about them quite frequently is more potentially CD 19, driven.
Speaker Change: Driven so we think there are areas, where it seems to me to be helpful. But overall.
Speaker Change: I think the overlap between CD 20, and see many team is going to be hard to distinguish in most diseases are and you know.
Speaker Change: The CD 19.
Speaker Change:
Speaker Change: When they hit its pre B cells. In addition to B cells.
Speaker Change: CD 20, only gets mature b cells, so in terms of recovery.
Michael S. Weiss: So in terms of recovery, you may see a difference there. I think there are a lot of things to balance when you think about CD19 versus CD20, but from an activity standpoint, in most diseases, I don't know that you're going to see a material difference.
Speaker Change: They see a difference there so I think there's a lot of things to balance when you think about CD 19 versus 'twenty, but from an activity standpoint in most diseases that I don't know if you can.
Speaker Change: See a material difference.
Prakhar Agrawal: Yeah, I just might want clarification. I was asking about the CD19 antibody, not the CAR T. Like, do you have a CD19 antibody in the early stage, even preclinical?
Speaker Change: Yeah, I guess, Mike one clarification that I was asking about 2019 antibody not the car T. Like do you have a CD 19 antibody in early stage even preclinical.
Michael S. Weiss: We don't. We don't. No, I don't find that to be a product of interest to us at this time.
Michael S. Weiss: We don't; we don't know.
Speaker Change: We don't we don't know I don't I don't.
Speaker Change: Don't find that to be a product of interest to us at this time.
Speaker Change: Got it thank you.
Speaker Change: Yeah.
Operator: Our next question comes from the line of Eric Joseph with J.P. Morgan. Please proceed with your question. Hi, good morning, guys.
Speaker Change: Our next question comes from the line of Eric Joseph with Jpmorgan. Please proceed with your question.
Noah: Uh, I'm not sure I understand the question. Could you clarify?
Noah: Hi, good morning, guys. This is Noah for Eric. Thanks for taking our question. We were just wondering if there were any other exclusive procurement opportunities similar to the contract that you just secured with the VA.
Eric William Joseph: Hi, Good morning, guys. This is on for Eric Thanks for taking our question.
Eric William Joseph: We were just wondering if there were other exclusive procurement opportunities are similar to the contract that you just secured with D. A.
Speaker Change: Okay.
Speaker Change: Adam.
Adam: Not sure I understand the question could.
Adam: Could you clarify.
Noah: Yeah, we're just wondering if there are other opportunities for tiered or exclusive access contracts with other providers going forward. Gotcha. Okay. Understood. I don't have any updates at this time on that question.
Speaker Change: Yeah, we're just I'm wondering if there are.
Speaker Change: Other opportunities for tier your exclusive access contrast with other.
Speaker Change: Other providers have going for production.
Speaker Change: Okay.
Adam: There.
Speaker Change: I don't have any updates at this time on that question.
Speaker Change: Got it thank you.
Speaker Change: Yeah.
Operator: Our next question comes from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.
Speaker Change: And our next question comes from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.
Corinne Jenkins: Hi, good morning, So maybe a couple of questions from ice one it strikes me that you guys are probably close to reaching profitability in the next quarter or two.
Corinne Jenkins: Good morning. So, we have maybe a couple of questions from us. One, it strikes me that you guys are probably close to reaching profitability in the next quarter or two, given the revenue guidance versus the OPEX guidance. How are you thinking through profitability versus kind of like ramping or expanding your R&D or SG&A spend to support the launch and future development? And then, from a technical perspective on the subcutaneous formulation, what else is left to do before you're able to enter the clinic? Thanks. Sure.
Corinne Jenkins: Guidance first the Opex and how are you thinking through profitability.
Corinne Jenkins: Very kind of like it's ramping or extending our R&D or SG&A smartwatch and feature development.
Corinne Jenkins: And then from a technical perspective on the subcutaneous formulation and asked them what else is left to do before you are able to enter the clinic.
Corinne Jenkins: Yeah.
Michael S. Weiss: Sure. So thinking about profitability, the, you know, I don't think those questions you asked are mutually exclusive or points, right?
Speaker Change: Sure so thinking about profitability.
Speaker Change:
Speaker Change: The and I don't think those questions. You asked are mutually exclusive or points right. So we have we will continue to invest in the Brown V launch.
Michael S. Weiss: So we have, and we will continue to invest in Brown v. Launch. We've noted that we've, you know, increased our OpEx budget to approximately $250 for the year. There's some room there to even grow.
Corinne Jenkins: We've noted that we've had.
Corinne Jenkins: Is an increased budget and opex to approximately 250 for the year. So.
Corinne Jenkins: There's some room there to even grow.
Michael S. Weiss: From a product standpoint, similarly, we are interested in continuing to build on the brand new opportunity, the Azure Solid Opportunity, and we've said that we will continue to look for additional external opportunities. So I don't know that we're fixated on the exact profitability numbers, and I know that may happen as EPS becomes something of interest, but I don't think it's mutually exclusive, and I do think we plan to continue to grow our Brionvi efforts and our team and continue with our R&D platform. But, you know.
Corinne Jenkins: From a product standpoint. Similarly, we are we are interested and continue to build among a brand new opportunity. The Asia saw opportunity and we've said that we will continue to look for additional external opportunities. So I don't know that were fixated on the exact profitability numbers and I know that need.
Corinne Jenkins: Hmm.
Corinne Jenkins: P S becomes something of interest, but I don't think that's mutually exclusive and I do think we plan to continue to grow.
Corinne Jenkins: Grow our beyond the efforts in our team and they can see what the R&D platform, but are you now.
Michael S. Weiss: As an overall company, I think our cost structure versus most other companies, not all but most, is pretty modest, and we've kept a pretty lean ship. So I think the consequence of that is we'll be at profitability probably sooner than most companies would, given the circumstances. In terms of the sub-Q technical aspects before entering the clinic, I think we're pretty much over most of the technical hurdles. I think we'll be able to get into the clinic, I believe, in the next two months or so.
Corinne Jenkins: As an overall company, our I think our cost structure versus most other companies not all but most of it was pretty modest and we've kept our we've kept a pretty lean ship.
Corinne Jenkins: So I think the consequence of that is will be at profitability, probably sooner than most companies would.
Corinne Jenkins: Given the circumstances.
Corinne Jenkins: In terms of the sub Q technical aspects before entering the clinic.
Corinne Jenkins: I think we're pretty much over most of the technical hurdles I think.
Corinne Jenkins: We will be able to get into the clinic I believe in the next two months or so.
Corinne Jenkins: And.
Michael S. Weiss: I think there's a continuing effort to make continued improvements in what we're working on, which will all just be filtering into the clinical program. But I don't think there are any technical hurdles right now; it's just getting going.
Corinne Jenkins: I think there's a continuing effort to to make continued improvements and what we're working on which all just be filtering into the clinical program, but I don't think there's any technical hurdles right now just getting you can go on.
Corinne Jenkins: Yeah.
Speaker Change: Thank you. Thank you.
Operator: We have reached the end of our question and answer session. And with that, I would like to turn the floor back over to Mike Weiss for any closing comments.
Speaker Change: We have reached the end of our question and answer session and with that I would like to turn the floor back over to Mike Weiss for any closing comments.
Michael S. Weiss: Great. Thank you, everybody. One second, please.
Michael S. Weiss: Great. Thank you everybody.
Speaker Change: Yeah.
Speaker Change: Okay.
Michael S. Weiss: Well, okay, so I just want to, you know, thank everyone for joining us today. Hopefully, everyone has been able to see the excitement and enthusiasm that we have here at TG and what's going on with the company. In our opinion, the first quarter was quite good; we think everything went extremely well, and we look forward to continuing to push forward and achieve even more as we move forward into the remainder of the year.
Michael S. Weiss: Well, okay. So I just wanted to thank everyone for joining us today are hopefully everyone has been able to to see the excitement and enthusiasm.
Michael S. Weiss: Again, we thank everyone for their support. Most importantly, we want to thank the clinicians and patients who have definitely put their trust into TG. The whole team really appreciates it. With that, I'd like to thank everyone for joining us and have a great day. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Michael S. Weiss: We have here at P G and what's going on with the company.
Michael S. Weiss: We were you know first quarter was a it was quite good in our opinion, we think everything went a went extremely well.
Michael S. Weiss: We look forward to continuing to push forward and achieve even more as we move forward into the remainder of the year.
Michael S. Weiss:
Michael S. Weiss: Again, we thank everyone for their support and most importantly, we want to thank the the clinicians and patients who definitely put their trusting to T. G. The whole team does appreciate it.
Operator: Thank you for watching!
Speaker Change: I'd like to thank everyone for joining us and have a great day.
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Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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