Q4 2023 TG Therapeutics Inc Earnings Call
Speaker Change: [music].
Operator: Greetings and welcome to the TG Therapeutics fourth quarter and year-end 2023 financial results and business update call. At this time, all participants are on a listen-only basis. This brief question-and-answer session will follow the formal process. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.
Greetings and welcome to the TG Therapeutics fourth quarter and year end 2023 financial results and business update call.
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.
As a reminder, this conference is being recorded it is now my pleasure to introduce your host Jenna Bosco. Thank you. Please go ahead.
Jenna Bosco: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and year-end 2023 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 development. 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. 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, 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.
Thank you welcome everyone and thanks for joining us this morning, I'm Jenna Bosco anyway with me today to discuss the fourth quarter and year end 'twenty two 'twenty three 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 development, 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.
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.
Forward looking statements include statements about our anticipated future operating and financial performance, including sales performance projected regulatory milestone revenue guidance development plans and expectations for our marketed products.
<unk> cautions that these forward looking statements are subject to risks.
May cause our actual results to differ differ materially from those indicated.
Jenna Bosco: Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our SEC filing. 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 SOARs local statement.
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 statements.
Jenna Bosco: This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I'd like to turn the call over to Mike Weiss, our CEO. Thanks, Jenna.
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 White our CEO.
Michael S. Weiss: And good morning, everyone. Thanks for joining us on today's call. 2023 was a transformational year for TG. We kicked off the year with the launch of Briumbi for relapsing forms of multiple sclerosis toward the end of January, and so the nice sales momentum carried throughout the year, resulting in approximately $90 million in U.S. Briumbi net revenue for our first partial year of sales. We believe these first-year revenues speak to the high level of early interest and strong underlying demand for Brionvi, and we look forward to continued carry through in 2024, where we are targeting $220 to $260 million in U.S. sales revenue. The feedback from physicians, patients, nurses, and infusion centers continues to be very positive and drives our confidence in both the short-term revenue ramp as well as the long-term blockbuster potential of Brionvi.
Michael Sean Weiss: Thanks Jana.
Good morning, everyone. Thanks for joining us on today's call.
Michael Sean Weiss: 2023 was a transformational year for T. J, we kicked off the year with the launch of <unk> for relapsing forms of multiple sclerosis towards the end of January and so a nice sales momentum carried throughout the year, resulting in approximately $90 million U S. <unk> net revenue for our first partial year of cells.
We believe these first year revenues speaks to the high level of early interest and strong underlying demand for gravity and we look forward to continued carry through 2024, where we're targeting $220 million to $260 million and U S sales revenue.
The feedback from physicians patients nurses and infusion centers continues to be very positive and drives our confidence in both the short term revenue ramps ramp as well as the long term blockbuster potential reality.
Michael S. Weiss: Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 for a dynamic market share perspective, and the early update supports our belief that that is possible. Having said that, this is a competitive market, and Brionbi is the newest entry, so differentiation matters. One obvious difference is that Briumv is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months after the starting dose, which may be an attractive profile for both patients who want to get back to their daily lives and for healthcare practices seeking to increase the efficiency within their infusion suites. Beyond the One Hour Fusion, we are excited to continue to explore Biologically based differences that may not be as readily apparent but are perhaps clinically relevant.
Michael Sean Weiss: Our team remains focused on our ultimate goal of becoming the number one prescribed CD 20 by dynamic market share perspective, and the early uptake supports our belief that that is possible.
Michael Sean Weiss: Having said that this is a competitive market and <unk> is the newest entry. So differentiation matters. One obvious difference is that brown is the only anti CD 20 monoclonal antibody that can be given as a one hour infusion every six months after the starting dose which may be an attractive profile for both pace.
Michael Sean Weiss: When he gets back to their daily lives every health care practices. She can seeking to increase the efficiency with Darren within their infusion suites.
Michael Sean Weiss: Beyond the one hour infusion we are excited to continue to explore.
Michael Sean Weiss: Biological based differences that may not be as readily apparent but are perhaps clinically relevant.
Michael S. Weiss: As a reminder, Briumvi is differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. Preclinical data demonstrate that compared to the other anti-CB20s approved or used to treat MS, 3MV has the highest binding affinity to CD20, the target for these types of drugs found on B-cells, and through its glycoengineering has the ability to induce the highest level of Whether or not these biological attributes of Brionbi have clinical relevance in patients with MS has not yet been determined, as no head-to-head trials have been conducted for Brionbi versus the other anti-CD20s. However, what has been well established is that Pranavir is the only anti-CD20 monoclonal antibody to achieve an annualized relapse rate of less than 0.1 in phase three trials. Awesome. Clinical Trials.
Michael Sean Weiss: As a reminder, reality is differentiated by design havent been glycol engineered for enhanced immune effector cell engagement and efficient b cell depletion.
Michael Sean Weiss: Preclinical data demonstrates that compared to the other anti CD 20 is approved we're used to treat them as reality has the highest binding affinity CD 20 target for these types of drugs.
Michael Sean Weiss: Found on B cells.
Michael Sean Weiss: That's the routes like go engineering is the ability to induce the highest level of antibody dependent cellular cytotoxicity, regardless of patient specific polymorphism.
Michael Sean Weiss: Whether or not these biological attributes of brumby have clinical relevance and patients with M. S has not yet been determined.
Michael Sean Weiss: No head to head trials have been conducted for free on the versus the other anti CD twenties.
Michael Sean Weiss: However, what has been well established.
Michael Sean Weiss: Is that probably is the only anti CD 21, Oklahoma antibody to achieve annualized relapse rate of less than 0.1 in phase III trials.
Also in.
Michael Sean Weiss: Clinical trials Gov.
Michael S. Weiss: Rhianvi rapidly depleted B-cells with a median of 96% reduction within 24 hours and 95% on-time infusion completion rate, which we believe speaks to the tolerability profile of Breon. As we move forward, we are eager to explore to what degree the Design Attributes of Brionzi may be contributing to the Robust Activity Scene. We plan to do more work to evaluate some of these unique attributes and to understand whether the molecular and non-clinical differentiation translates into clinical differences, and we look forward to sharing more on that when available. I also wanted to highlight another recent exciting development. We were pleased to share yesterday that, in addition to our current Brionbi patent and U.S. Biologics exclusivity, the U.S. Patent and Trademark Office recently issued three additional patents for Brionbi, including a Composition of Matter patent related to the glycoengineered attributes of Brionbi. With these additional patents, our patent protection now extends through 2042, providing us with a nice long runway to continue to explore the full potential of Brionbion, including expanding the potential reach of Brionbion MS, as well as into other autoimmune diseases. Which is a good segue to discuss what is next for Browmbie and TG.
Michael Sean Weiss: We're gonna be rapidly depleting b cells with a median of 96% reduction within 24 hours and.
And 95% odd time infusion completion rate, which we believe speaks to the tolerability profile umbrella.
Michael Sean Weiss: As we move forward, we are eager to explore to what degree.
Michael Sean Weiss: The design attributes of Brianti may be contributing to the robust activity seen we plan to do more work to evaluate some of these unique attributes.
Michael Sean Weiss: Your stand whether the molecular non clinical differentiation translates into clinical differences and we look forward to sharing more on that one available.
Michael Sean Weiss: I also wanted to highlight another recent exciting development.
Michael Sean Weiss: We were pleased to share yesterday, then in addition to our current reality patent and U S. Biologics exclusivity U S patent and trademark office recently issued three additional patents were biamby, including a composition of matter patent related to the glycol engineered attributes of reality.
Michael Sean Weiss: With these additional patents or patent protection now extends through 2042.
Michael Sean Weiss: Providing us a nice long runway to continue to explore the full potential of rounding including extending the potential reach of Brown V and M S as well as into other autoimmune diseases.
Michael Sean Weiss: Which is a good segue to discuss what is next for Brown B and T. G. First let me say that the U S around the launch and commercialization is and will remain our highest priority that said our drug development team is poised and ready to potentially drive additional value through Brownsville lifecycle management activities as well as new draw.
Michael S. Weiss: First, let me say that the U.S. Browmbie launch and commercialization is and will remain our highest priority. That said, our drug development team is poised and ready to potentially drive additional value through Browmbie lifecycle management activities as well as new drug development. More specifically, we are focused on four key areas. First, making IV pre-EMV even more convenient.
Michael Sean Weiss: Development.
Michael Sean Weiss: More specifically we are focused in four key areas.
Michael Sean Weiss: First and making IV bring them be even more convenient last year, we presented the first data from the enhance phase III trial of which the bowls to evaluate the safety and efficacy of eliminating the four hour Brie M. D 150 milligram starting dose for patients who are switching.
Michael S. Weiss: Last year, we presented the first data from the Enhanced Phase 3b trial, of which the goal is to evaluate the safety and efficacy of eliminating the four-hour pre-EMV, 150 milligrams starting dose for patients who are switching from a prior CD20 and have a pre-specified low level of B cells. Early safety data from this study is encouraging, and we look forward to presenting additional safety and efficacy data this year, including at the Actions Conference, which is happening later this week. A second key area for us is developing subcubria.
Michael Sean Weiss: From a prior CD 20, and they'd be prespecified low level of B cells early safety data from this study is encouraging and we look forward to presenting additional safety and efficacy data this year, including an act at the actress Conference, which is happening later this week.
Michael Sean Weiss: Our second key area for US is developing sub Kubrick LNG, we have completed a preliminary sub Q formulation and are preparing to enter human bioequivalence studies. This year. We believe there's a few market could represent a significant new market opportunity for us as the IV and subcutaneous <unk>.
Michael S. Weiss: We have completed our preliminary sub-Q formulation and are preparing to enter human bioequivalent studies this year. We believe the sub-Q market could represent a significant new market opportunity for us as the IV and sub-Q CD20 markets within RMS are rather distinct. Given the known profile of the currently available subcube and the profile of the other one under development, we believe there's plenty of room to strive to develop a potentially best-in-class subcube CD20 product. Third, we are looking forward to expanding the realm beyond MS. There are multiple other disease indications where CB20s have proven to have utility.
Michael Sean Weiss: Any markets within RMS are rather distinct given the known profile of the currently available sub Q and the profile of the other one underdevelopment. We believe there's plenty of room to strive to develop a potentially best in class sub acute C. D 20 products.
Michael Sean Weiss: Third we are looking forward to expanding realm beyond M. S. There are multiple other disease indications where C. V twenties have proven to have utility well look forward to launching our first autoimmune trial outside of and that's this year.
Michael S. Weiss: We look forward to launching our first autoimmune trial outside of MS this year, and so forth and so on. Finally, we are focused on new drug development and are extremely excited by our recent portfolio expansion. Last month, we entered into a partnership with Precision Biosciences to acquire a worldwide license to Precision's Acer Cell Allogeneic CD19 CART-T Cell Therapy Program for autoimmune diseases and all other non-oncology indications. We believe AzerCell has the potential to be a first-in-class, best-in-class treatment for certain autoimmune diseases. As an allogeneic, off-the-shelf product, we think AzerCell may offer benefits over autologous CAR-T treatment. Overall, we believe AzerCell is a great fit for us and an important addition to our current pipeline. Azrcel has been used to treat over 80 cancer patients, and we look forward to hopefully treating the first autoimmune patients with Azrcel as soon as possible, with an IMD filing targeted for mid-year.
Michael Sean Weiss: And fourth and finally.
Michael Sean Weiss: Excuse me, we are focused on new drug development and are extremely excited by our recent portfolio expansion last month, we entered into a partnership with precision biosciences to acquire a worldwide license to precision ease yourself alginate CD 19 car T cell therapy program for autoimmune diseases and.
All other non oncology indications.
Michael Sean Weiss: We believe he's yourself has the potential to be first in class best in class treatment for certain autoimmune diseases.
Michael Sean Weiss: As an allogeneic off the shelf product, we think he's yourself may offer benefits overall Italian car T treatments overall.
Michael Sean Weiss: Overall, we believe he's yourselves a great fit for us and an important addition to our current pipeline.
Michael Sean Weiss: Is there still has been used to treat over 80 cancer patients and we look forward to hopefully treating the first autoimmune patients, but these are so as soon as possible with a 90 day filing targeted for midyear.
Michael S. Weiss: As you can see, we've put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders. We have been and will continue to be measured in our approach to R&D from a capital allocation perspective, including in our approximately $250 million projected 2024 operating budget. These dollars are required to expand our pre-OMB field teams, increase our marketing spend, as well as move forward all of the current development plans we've just discussed. With that, as I bring my previous remarks to a close, I'd like to say how incredibly proud I am of the team and the progress we've made in 2023. We built a top-notch MS-focused commercial team that enabled us to rapidly integrate TG and Briumbe into the MS ecosystem, and we will continue to build upon this foundation, with TG as a trusted partner to the MS community as we strive to serve the patients we treat to the best of our ability. Finally, I also want to congratulate our ex-U.S. partner, Nurex Farm, on the official launch of Pre-Ombie in Europe, which took place this week in Germany.
Michael Sean Weiss: As you can see we have put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders. We have been we have been and will continue to be measured in our approach to R&D from a capital allocation perspective, including including included in our <unk>.
Michael Sean Weiss: <unk> 250 million projected 'twenty 'twenty, four operating budget or the dollars required to expand our field teams and increase our marketing spend as well as new moving forward all of the current development plans are just discussed.
Speaker Change: With that as I put in my prepared remarks to a close I'd like to say, how incredibly proud I am of the team and the progress. We've made in 2023, we built a top notch emmis focused commercial team has enabled us to rapidly integrate T. G. Every upbeat into the M S ecosystem.
Speaker Change: We continue to build upon this foundation.
Speaker Change: With the with T G as a trusted partner to the M. S community as we strive to serve the patients we treat to the best of our ability.
Speaker Change: Finally, I also want to congratulate our ex U S partner next farm on the official launch of <unk> in Europe, which took place. This week in Germany, we look forward to hearing more about their progress as they endeavor to commercialize crown being Europe and the rest of the world.
Adam Waldman: We look forward to hearing more about their progress as they endeavor to commercialize Pre-Ombie in Europe and the rest of the world. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update on the Buranba U.S. Commercial Launch. Adam?
Speaker Change: With that let me hand, the call over to Adam Waldman, Our Chief commercialization officer provide a detailed update of the program in the U S commercial launch Adam.
Adam Waldman: Yeah, thank you, Mike. And good morning, everyone. I'm pleased to share with you the results for the fourth quarter and cover the highlights from our Brionvi commercial launch performance in 2023. Launching Brionbi last year was a transformational event for our company. We've built a strong commercial infrastructure that delivered exceptional results, exceeded expectations on the launch, and now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. And, more importantly, we made a positive difference in the lives of thousands of people living with MS. As reported at the JPMorgan Conference last month, fourth-quarter net sales for Brionvi were $39.9 million, representing 60% growth The fourth quarter number exceeded our guidance and reflects the growing demand we are seeing for preempt. We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting. We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at these centers continue to decrease.
Adam Waldman: Yep. Thank you, Mike and good morning, everyone I'm pleased to share with you the results from the fourth quarter and cover the highlights from our <unk> commercial launch performance in 2023.
Adam Waldman: Launching brown B last year was a transformational event for our company. We built a strong commercial infrastructure that delivered exceptional results exceeded expectations on the launch and now provides a solid platform from which to build potential blockbuster products and enough and capitalize on other autoimmune disease opportunities going forward and more.
Adam Waldman: Accordingly, we made a positive difference in the lives of thousands of people living with MFS.
Adam Waldman: As reported at the J P. Morgan Conference last month fourth quarter net sales for <unk> were $39 9 million, representing 60% growth quarter over quarter, and bringing our full year 2023 revenues in at $89 million.
Adam Waldman: The fourth quarter number exceeded our guidance and reflects the growing demand we're seeing for biamby.
Adam Waldman: We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting Bradley.
Adam Waldman: We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at the centers continued to decrease in fact in the fourth quarter. In fact, the fourth quarter was the first time, we saw more scripts from academic centers.
Adam Waldman: In fact, the fourth quarter was the first time we saw more scripts from academic centers than from private practice centers, which we view as positive progress given that 60 to 65 percent of patients are being seen by MS specialists in the academic setting, and this has been a focus for our team as we headed into the end of the year. Overall, in 2023, we saw approximately 3,200 new patient prescriptions come through our hub, which we believe translates into about 3,500 total new patient scripts, as not all new prescriptions will come into our hub. We're also pleased to see a wide distribution of use, with new prescriptions coming from over 400 centers and 640 unique prescribers. Encouragingly, we also saw a diverse mix of patients, including those that were naive to all treatments and those that were previously treated and switched from both non-CD20 and CD20 agents. This mix of patient types remained fairly consistent throughout the year, with the largest group consisting of patients that were previously treated but naive to anti-CD20 therapy.
Adam Waldman: The private practice, setting, which we view as positive progress given that 60% to 65% of patients are being seen by Ms specialists in the academic setting and this has been a focus for our team as we headed into the end of the year.
Adam Waldman: Overall in 2023, we saw approximately 3200, new patient prescriptions come through our hub.
Adam Waldman: Which we believe translates into about 3500 total new patient scripts as not all new prescriptions will come into our homes. We're also pleased to see a wide distribution of use with new prescriptions coming from over 400 centers.
Adam Waldman: 640 unique prescribers.
Adam Waldman: Encouragingly, we also saw a diverse mix of patient types, including those that were naive to all treatments and those that were previously treated and switch from both non CD 20, and CD 20 agents.
Adam Waldman: This mix of patient types remained fairly consistent throughout the year with the largest group consisting of patients that were previously treated but naive to anti CD 20 therapy.
Adam Waldman: We were also highly encouraged by the persistence of returning patients, which so far appears to be consistent with our assumptions, which were based on what had been seen with the other IV anti-CD20 on the market. From an execution perspective, our teams did an exceptional job delivering on our launch plan in 2023. We had a well-designed and targeted launch strategy, efficiently focusing our resources on driving adoption at high-volume, targeted accounts where we sell the vast majority of our business. At this point, approximately 90% of the top 100 centers in the U.S. have utilized Brionbio. And with the lowest price of any branded medicine for MS, we prioritize gaining early access and coverage, and we're able to achieve coverage for 95% of commercial and Medicare lives within the first nine months alone.
Adam Waldman: We were also highly encouraged by the persistence of returning patients, which so far appears to be consistent with our assumptions, which was based on what had been seen with the other anti <unk> IV anti CD 20 on the market.
Adam Waldman: From an execution perspective, our teams did an exceptional job delivering on our launch plan in 2023, we had a well designed and targeted launch strategy efficiently focusing our resources on driving adoption at high volume targeted accounts, where we saw the vast majority of our business at this point approximately 90% of the top 100 centers in the U S. A.
Adam Waldman: Utilize branding.
Adam Waldman: And with the lowest price of any branded medicine for M. S. We probably prioritize getting early access and coverage and we're able to achieve coverage for 95% of commercial and Medicare lives within the first nine months of launch we built a best in class patient support team and our highly experienced and well networked field teams have done an incredible job.
Adam Waldman: Listing T G as a respected partner in the Ms community.
Adam Waldman: We built a best-in-class patient support team, and our highly experienced and well-networked field teams have done an incredible job establishing TGE as a respected partner in the MS community. We are very proud of our teams and believe their outstanding efforts are contributing to the positive experience with Brionbi and continue to build confidence in our organization. The cumulative facts of what we've accomplished certainly helped to drive the momentum that we saw in 2023, and we expect to see that momentum carry forward this year. Looking forward, we see the CD20 market continuing to grow. This class of drugs has transformed the way that MS is treated over the last five years.
Adam Waldman: We are very proud of our teams and believe their outstanding efforts are contributing to the positive experience with brown b and continue to build confidence in our organization.
Adam Waldman: The cumulative facts of what we've accomplished certainly helped to drive momentum that we saw in 2023 and.
And we expect to see that momentum carry forward this year.
Adam Waldman: Looking forward, we see the CD 20 market continuing to grow this class of drugs has transformed the way that that M. S has treated over the last five years.
Adam Waldman: With the CD 20 share continuing to grow and now capturing approximately 50% to 55% share of new patients every year and.
Adam Waldman: And we would expect that that will that will expand even further going forward.
Adam Waldman: We believe this is a continued tailwind for our business. We also expect that most patients in centers will continue to prefer and fixed in a every six month IV dosing schedule.
Adam Waldman: With the CD20 share continuing to grow and now capturing approximately 50 to 55% of new patients every year, and we would expect that that will expand even further going forward. We believe this is a continued tailwind for our business. We also expect that most patients and centers will continue to prefer an every six month IV dosing schedule, where patients don't have to think about their disease every day or every month, and providers have the confidence that their patients are being compliant in receiving their medication.
Where patients don't have to think about their disease every day or every month and providers have the confidence that their patients are being compliant receiving their medications.
Adam Waldman: We estimate there are approximately 40000 patients going onto CD 20 therapy, each year or about 10000 patients per quarter and in the fourth quarter of 2023, we had approximately 1000 prescriptions come into the T. G hub.
Adam Waldman: Which would reflects approximately a 10% market share if if all these patients were infused since not all these patients prescribed <unk> will actually be infused. These prescriptions through the hub will not translate precisely in the market share.
Adam Waldman: But nevertheless, we do believe this is an indicator of strong early demand for <unk>, especially in their first year of launch.
Adam Waldman: We estimate there are approximately 40,000 patients going on CD20 therapy each year, or about 10,000 patients per quarter. And in the fourth quarter of 2023, we had approximately 1,000 prescriptions come into the TG Hub, which would reflect approximately a 10% market share if all these patients were infused. However, since not all these patients prescribed Briumvi will actually be infused, these prescriptions through the hub will not translate precisely into the market share.
Adam Waldman: We also believe we have significant room to grow in what is a large and growing and expanding market based on our market research and extensive interaction with neurologists. We continue to believe Brown. These profile remains very compelling and will eventually be the IV therapy of choice in the relapsing Ms market. This will of course take us time to achieve but that's.
Adam Waldman: Very much what we're focused on doing.
Adam Waldman: In 2024 will expand our targets and continue to work on educating our customers on the Brown B difference.
Adam Waldman: We will also continue to ramp up our efforts to increase patient awareness, which we believe can be an important driver in this market.
Adam Waldman: But nevertheless, we do believe this is an indicator of strong early demand for Briumvi, especially in our first year. We also believe we have significant room to grow in what is a large, growing, and expanding market. Based on our market research and extensive interaction with neurologists, we continue to believe Brown v. Profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market.
So far this year is off to a really strong start where we have seen record enrollments into our hub in January.
Adam Waldman: And we believe we're tracking towards the upper end of our first quarter guidance range of $41 million to $46 million.
Adam Waldman: And potentially higher if demand demand trends persist over the next month.
Adam Waldman: We also feel very good about our full year guidance of $220 million to $260 million, which we provided at J P. Morgan.
Adam Waldman: This will, of course, take us time to achieve, but that's very much what we're focused on. In 2024, we'll expand our targets and continue to work on educating our customers on Brown v. DiFiore. We'll also continue to ramp up our efforts to increase patient awareness, which we believe can be an important driver in this market. So far, this year is off to a really strong start, where we have seen record enrollments into our hub in January, and we believe we are tracking towards the upper end of our first quarter guidance range of 41 to 46 million, and potentially higher if demand trends persist over the next year. We also feel very good about our full-year guidance of $220 to $260 million, which we provided at JPC.
Adam Waldman: We certainly have work to do but where we're focused and extremely motivated to continue to work every day to bring <unk> to those people living with them and their families.
CFO: With that I'll call I'll turn the call over to show empower our CFO.
CFO: Thank you Adam and thanks again to everyone for joining US earlier. This morning, we reported our detailed fourth quarter and full year 2023 financial results, which can be viewed on the investors and media section of our website.
CFO: This morning, I'll start with a discussion of our revenue for the fourth quarter and full year of 2023.
CFO: As previously mentioned, we are pleased to report U S. Pre M. B net product revenue of $39 9 million during the fourth quarter.
CFO: Also included in our total net product revenue for the fourth quarter is approximately $3 2 million of revenue from products sold generics farm in support of the ex U S. Commercial launch and 800000 of other revenue taking total revenue for the fourth quarter to approximately $44 million as.
Sean A. Power: We certainly have work to do, but we are focused and extremely motivated to continue to work every day to bring Briambi to those people living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO. Thank you, Adam.
CFO: <unk>.
Sean A. Power: And thanks again to everyone for joining us. Earlier this morning, we reported our detailed fourth quarter and full year 2023 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 for the fourth quarter and full year of 2023. As previously mentioned, we are pleased to report U.S. pre-OMB net product revenue of $39.9 million during the fourth quarter. Also included in our total net product revenue for the fourth quarter is approximately $3.2 million of revenue for products sold to NeuroX Pharm in support of the XUS commercial launch, and $800,000 of other revenue For the full year, we reported total revenue of approximately $234 million, which was predominantly comprised of $88.8 million in U.S. Breamby net product sales, $140 million in license revenue stemming from the upfront payment for our ex-U.S. commercialization agreement with NeuroX Pharm, and $3.2 million in product revenue for products sold to NeuroX Pharm, as previously mentioned.
CFO: For the full year, we reported total revenue of approximately $234 million, which is predominantly predominantly comprised of $88 8 million in U S net product sales.
CFO: $140 million in license revenue stemming from the upfront payment for ex U S commercialization agreement with <unk> Pharm.
CFO: And $3 2 million in product revenue for products sold sooner Alex farm yesterday's dimensions.
CFO: Our opex during the fourth quarter and full year has remained well controlled and in line with previously discussed ranges for.
CFO: For the fourth quarter and full year 2023, our operating expenses were $56 million and $213 million, respectively, which includes Cogs of $7 8 million and $14 1 million in the respective periods.
CFO: When excluding noncash compensation, our cash operating expenditures during the fourth quarter and full year 2023 were approximately $47 million and $175 million respectively.
CFO: On the back of the reported revenues and well controlled the Opex. We were able to report net income of $12 7 million or nine cents per diluted share during the full year of 2023.
CFO: For the fourth quarter of 2020, three we reported a net loss of $14 4 million or nine cents per diluted share.
CFO: And finally from a cash standpoint, we ended the year with approximately 217 and a half million dollars in cash cash equivalents and investment securities.
Sean A. Power: Our OPEX during the fourth quarter and full year remained well controlled and in line with previously discussed ranges. For the fourth quarter and full year 2023, our operating expenses were $56 million and $213 million, respectively, which included COGS of $7.8 million and $14.1 million in the respective period. When excluding on-cash compensation, our cash operating expenditures during the fourth quarter and full year 2023 were approximately $47 million and $175 million, respectively. On the back of the reported revenues and well-controlled OPEX, we were able to report net income of $12.7 million, or $0.09 per diluted share, during the full year of 2023. For the fourth quarter of 2023, we reported a net loss of $14.4 million, or $0.09 per diluted share.
CFO: And we believe our current cash position coupled with our previously guided revenue and expense guidance.
CFO: It 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.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Thank you the floor is now open for questions.
Speaker Change: To ask a question. Please press star one on your telephone keypad at this time, a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up the handset before pressing the star keys.
Speaker Change: Again, Thats Star one to register a question at this time.
Speaker Change: Today's first question is coming from Michael <unk> of Evercore. Please go ahead.
Speaker Change: Hi, This is Jessica on for Mike.
Jessica: My first question is in the past you guys have said that you've heard anecdotal reports of patients not petering out in the days and weeks, leading up to you I guess subsequent Brian V dose, which is not always the case with competitor anti F. 'twenty.
Operator: And finally, from a cash standpoint, we ended the year with approximately $217.5 million in cash, cash equivalents, and investment security. We believe our current cash position, coupled with our previously guided revenue and expense guidance, provides us with sufficient capital to fund our operations with cash flow positivity. With that, I will now turn the call over to the conference operator to begin the Q&A. Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at the confirmation tone will indicate your line is active. You may press star 2 if you would like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the button to give that star one to register.
Jessica: So what's been feedback on this front and how much do you see.
Jessica: Treatment duration as a key differentiating factor and then also if I can sneak in another question. What can we expect on an question that cadence for the balance of it yeah. Thank you.
Speaker Change: Got it thanks for the question Adam you want to field. The first one and then Sean.
Adam Waldman: I'll take the second.
Speaker Change: Persistence I assume you mean, the discontinuation rate.
Speaker Change: For patients going from.
Speaker Change: First your second infusion to the 13th season as you know, it's it's still it's still early but what I said in my remarks is through so far the the trends seem positive and around what we expected based on what we saw with the other Ibs C and in 'twenty.
Speaker Change: So it's right in that range I don't have any information right now to say that it is better.
Operator: Today's first question is coming from Michael DiFiore of Evercore. Please go ahead. Hi, this is Jessica on behalf of Mike.
Speaker Change: Certainly don't have any information to say that's worth depends right, where we expected.
Unknown Speaker: My first question is, in the past, you guys have said that you've heard anecdotal reports not petering out in the days and weeks leading up to their subsequent Braham vetoes, which is not always the case with competitor anti-CD20s. So what's been the feedback on this front and how much do you see, Braham? And then also, if I can sneak in another question, what can we expect on growth to net cadence for the balance of the year? I got it. Thanks for the question. Adam, you want to field the first one, and then I'll have Sean take the second. Persistence, I assume you mean the discontinuation rate for patients going from first or second infusion to third infusion.
Speaker Change: And we'll continue to look at it certainly if it's more positive than we think certainly that will be a accelerating going forward.
Speaker Change: Yes.
Speaker Change: Alright, and then on the gross to net but we have not provided go important forward guidance on what to expect.
Speaker Change: There will be some variability quarter to quarter, but again not precise.
Speaker Change: Precise guidance on what 'twenty 'twenty four will look like.
Speaker Change: Great. Thank you.
Speaker Change: Yeah.
Speaker Change: Thank you. Thank you. The next question is coming from Ed White of H C. Wainwright. Please go ahead.
Ed White: Good morning, Thanks for taking my questions.
Ed White: Just wondering if you have any numbers on the switches from prior.
Adam Waldman: As you know, it's still early, but what I said in my remarks is true. So far, the trends seem positive and around what we expected based on what we saw with the other IV CD20, so it's right in that range. I don't have any information right now to say that it's better, and certainly don't have any information to say that it's worse, but it's right where we expected.
Ed White: Prior therapies.
Ed White: And how that's impacting your your sales growth.
Ed White: Yeah, So I'll start there and Adam can jump in we haven't provided anything new I mean, what we've said previously and it still holds true is that in terms of distribution of patients we see about.
Adam Waldman: We have three buckets just to be clear those patients that are now used to all treating those patients that switch from a non CD 20.
Sean A. Power: And we'll continue to look at it. Certainly, if it's more positive than we think, certainly that will be an accelerator going forward. Hi, and on the growth to net front, we have not provided going forward guidance on what to expect. There will be some variability quarter to quarter, but again, we haven't provided precise guidance on what 2024 will look like.
Adam Waldman:
Adam Waldman: Products to see it in 'twenty. So there's the non CD training the soothing 20 switches.
Adam Waldman: What we said is that the the largest group coming on temporary onvia or those that were naive to to see the 20, but were pre treated with something else.
Adam Waldman: And then the other two buckets one are not equal to each other are relatively similar.
Unknown Speaker: Thank you. Good morning, thanks for taking my question. So, I'm just wondering if you have any numbers on the switches from prior therapy and how that's impacting your sales growth. Yes, I'll start there, and Adam can jump in. We haven't provided anything new.
Adam Waldman: And there they are.
Adam Waldman: Reasonably close to the first bucket so they usually there's a nice distribution across all all the buckets.
Speaker Change: Okay, Thanks, Mike and.
Europe: Europe, congratulations on getting the launch in Germany.
Speaker Change: Can you give us your thoughts on the launch in Germany, and you know and in other countries and perhaps the cadence of future milestone payments.
Michael S. Weiss: I mean, what we've said previously, and it still holds true is that in terms of the distribution of patients we see, we have three buckets. Just to be clear, there are patients that are naive to all treatment. There are patients that switch from non-CD20 products to a CD20. So there's the non-CD20, and then there's the CD20 switches. What we've said is that the largest group coming on to Brionbi are those that were naive to CD20 but were pre-treated with something else. And then the other two buckets, while they're not equal to each other, are relatively similar.
Speaker Change: Yeah, Adam you've been close do you want to take a crack.
Speaker Change: Yeah.
Speaker Change: Sure.
Adam Waldman: Hi, Ed So yeah, as you know and as we've spoken about before getting the launch in Germany was a really important it's the biggest market by far in Europe, So getting that going out of the start was was important and we're right on track with that which is great.
Michael S. Weiss: And they're reasonably close to the first bucket. So there's usually, there's a nice distribution across all the buckets. Okay, thanks, Mike. And on Europe, congratulations on getting the launch in Germany. Can you give us your thoughts on the launch in Germany and, you know, in other countries and perhaps the cadence of future milestone payments? Yeah, Adam, you've been a lot closer. You want to take a crack at it? Sure. Hi Ed.
Adam Waldman: The other country. The other countries will start to come in.
Adam Waldman: Later part of this year into next year, including the UK, France, Spain, Italy.
Adam Waldman: And they're continuing to work with the reimbursement authorities in getting through the process, they need to and making for the drug and can be accessed their working diligent diligently on that they have a lot of experience doing it and we'll continue to work through the process, but Germany is by far the largest opportunity.
Adam Waldman: So, yeah, as you know, and as we've spoken about before, getting BreMV launched in Germany was really important. It's the biggest market by far in Europe, so getting that going from the start was important, and we're right on track with that, which is great. The other countries will start to come in the latter part of this year and next year, including the UK, France, Spain, Italy, and they're continuing to work with the reimbursement authorities in getting through the process they need to in making sure the drug can be accessed.
Adam Waldman: And the one that we prioritized first.
Speaker Change: Yeah, and then just on the cadence of a future milestones.
Speaker Change: We're not expecting any additional milestones this year.
Speaker Change: There's a chance we would see a milestone towards the end of next year, an additional milestone.
Speaker Change: But we will get more and more of that later, but I wouldn't expect any additional milestones this year.
Speaker Change: As we reported at Jpmorgan, obviously, it's a launch year for these folks and we're not expecting.
Speaker Change: A whole lot in royalty revenues as well.
Speaker Change: Okay. Thanks, Mike and just lastly, Adam had mentioned, adding to the sales force and expanding your reach.
Adam Waldman: They're working diligently on that, and they have a lot of experience doing it, and we'll continue to work through the process. But Germany is by far the largest opportunity and the one that we prioritized.
Speaker Change: Okay.
Speaker Change: How should we be thinking about that as far as the growth over the ramp of SG&A expenses.
Michael S. Weiss: Yeah, and then just on the cadence of future milestones, we're not expecting any additional milestones this year. There's a chance we could see a milestone toward the end of next year, an additional milestone, but we'll get more on that later. But I wouldn't expect any additional milestones this year. And, as we reported to Morgan, obviously, it's a launch year for these folks, and we're not expecting Okay, thanks, Mike. And just lastly, Adam mentioned adding to Salesforce and expanding your reach. How should we be thinking about that as far as growth or the ramp-up of SG&A expenditure is concerned? Are you currently adding?
Speaker Change: Are you currently adding it's something that we should see in the second half of the year just any guidance that you can give us on how you're expanding your sales force.
Yes.
Speaker Change: I'll chime in an atom and Sean can jump in afterwards, so yeah. So as it stands today, even in the fourth quarter.
Speaker Change: Some of that expansion I'd say most of that expansion is already included the current extension process. So it's already probably built in most of it into the fourth quarter and they'll probably be a little bit more of that trickles into the first.
Speaker Change: First quarter.
Michael S. Weiss: Is this something that we should see in the second half of the year? Just any guidance that you can give us on how you're expanding your sales. Yeah, so I'll chime in, and Adam can, and Sean can jump in afterwards. So yeah, so as it stands today, even in the fourth quarter, some of that expansion, actually, most of that expansion is already included in the current expansion process. So it's probably built most of it into the fourth quarter, and there'll probably be a little bit more that trickles into the first quarter. And then it's possible, over the course of the year, there'll be a slow additional build.
Sean A. Power: And then it's possible over the course of the year.
Sean A. Power: They'll be slow additional build.
Sean A. Power: But most of it is already incorporated in and for sure. It's incorporated into our our Opex estimate of approximately 250 million for the year. So that's all that's all built in.
Sean A. Power: Two what we're what we have.
Sean A. Power: Heidi already.
Sean A. Power: Okay.
Sean A. Power: Okay.
Speaker Change: You got it thanks.
Roger Song: Thank you. The next question is coming from Roger song of Jefferies. Please go ahead.
Speaker Change: Hi, This is <unk> on for Roger Hi, Mike and team and good morning.
Michael S. Weiss: But most of it's already incorporated. And for sure, it's incorporated in our OPEX estimate of approximately 250 million for the year. So that's all that's built in to what we're already guiding. You got it.
Speaker Change: What timeframe do you think it's possible.
Speaker Change: To achieve the number one prescribed IV CV 20 <unk> by.
Speaker Change: Danny make sure and then the second question are there any remaining gating factors for you to enter at the Bioequivalence studies for <unk> formulations of <unk>.
Adam Waldman: Thanks. Thank you. The next question is coming from Roger Song of Jeffreys. Please go ahead. Hi, this is Kambizan for Roger. Hi, Mike, and team. Good morning.
Speaker Change: Yeah, you broke up a little bit at the end there, but I think I got it in terms of timeframe to be number one.
Unknown Speaker: What time frame do you think it's possible to achieve the number one prescribed IVCV 20 for BMV by, Unknown Speaker share. The second question, are there any remaining gating factors for you to enter the human and bioequivalent studies for sub-U formulation? Yeah, you broke up a little bit at the end there, but I think I got it in terms of timeframe to be number one.
Danny: We havent set a timeframe yet so I can't share one it's it's a goal that we have and we're going to keep working toward it but certainly as we get further along.
Danny: I don't anticipate 24 will be the year that we do that so I think that that that's pretty sure about that but.
Michael S. Weiss: We haven't set a timeframe yet, so I can't share one. But it's a goal that we have, and we're going to keep working toward it. But certainly, as we get further along, I mean, I don't anticipate 24 will be the year that we do that, so I think that's pretty certain about that, but we are working toward that, and we'll keep you posted. In terms of the sub-2 development... We do have our preliminary SOQ formulation that we want to take into the clinic. We don't think that there's anything in our way to do that. We've got some filing to do, but it should be pretty straightforward, and we're hoping to have patients on, you know, hopefully by midyear. And then maybe as a couple follow-up questions, is there any preparatory work required to enter Brionbi into studies outside of MS?
Danny: But we are working towards that and we'll keep you posted.
Danny: In terms of the sub two development.
Danny: We do have are.
Danny: Preliminary a sub Q formulation that we want to take into Q.
Danny: Into the.
Danny: And to the clinic.
Danny: We don't think that there's anything in our way to do that we've got that.
Danny: Some filings to do but it should be pretty straightforward and.
Danny: And we're hoping to have patients on.
Danny: Hopefully by mid year.
Speaker Change: And then maybe as a couple of follow up questions are there is there any preparatory work required to enter biamby into but outside of that now.
Speaker Change: And the last question, we've noticed theres still a small number of scripts and third party trackers. Some investors are still curious about the trends maybe we could put this topic to bad for once at all do.
Michael S. Weiss: And as a last question, we've noticed there's still a small number of scripts and third-party trackers. Some investors are still curious about that. Maybe we could put this topic to bed for once and all. Do you see any value at all in third-party script tracking data?
Speaker Change: Do you see any value.
Speaker Change: And the third party expert.
Yeah.
Speaker Change: Yeah.
Speaker Change: Certainly love that.
Speaker Change: Adam you want to hit that one.
Adam Waldman: Yeah, I would certainly love that. Adam, you want to want to hit that one? Roger Song, TG Therapeutics Inc. You know, the data you're seeing is SP data, which is a very small portion of our business lesson. So, to put it to bed, I would say it is absolutely not something I would look at.
Speaker Change: Third party answer yes.
Adam Waldman: From what I understand Roger.
Adam Waldman: Sorry, so what I understand is.
Adam Waldman: The data you're seeing is S. P data, which is a very small portion of our business less than 10%. So yeah to put it to bed.
Adam Waldman: I would say it is absolutely not something I would look at.
Adam Waldman: Thank you. And then your last question about moving outside of MS, I don't think there's any..., any pre-work that we need to do. I think it's just the logistics of getting it done within the context of all the other things that we have on our plate for this year. So that's probably a later event in the year event than in earlier years.
Adam Waldman: Okay. Thank you and then and then your last question about moving outside of M. S.
Adam Waldman: I don't think there's any.
Adam Waldman: Any pre work that we need to do I think it's just.
Adam Waldman: Just logistics of getting it done within the context of all the other things that we have on our plate for this year. So that's probably a later later in the year event and an earlier year I think we've got.
Michael S. Weiss: I think we've got the higher priority projects will be the stuff I talked about where we're trying to make IV pre-op even more convenient. The sub-Q and the azer cell stuff is probably on the higher priority setting for the earlier part of the year. But yeah, I don't see any barriers to going outside of MS.
Adam Waldman: The higher priority projects will be.
Adam Waldman: The the stuff I talked about we're trying to make IV priyanka, even more convenient.
Adam Waldman: Sub Q and the ease yourself stuff is probably on.
Adam Waldman: The higher priority settings.
Adam Waldman: The early part of the year, but yeah, I don't see any barriers to going outside of that mess.
Michael S. Weiss: Thanks, Mike. Appreciate it. Thank you guys, thank you. Thank you. The next question is coming from Matt Kaplan of Ladenburg-Thelman. Please go ahead. Hey, good morning, guys, and congrats on the progress. Um, just to stay on the enhanced.
Thanks, Mike I appreciate it.
Speaker Change: Yes, you got it thank you.
Thank you. The next question is coming from Matt Kaplan of Ladenburg Thalmann. Please go ahead.
Matt Kaplan: Hey, good morning, guys and congrats on the progress.
Matt Kaplan: Just to stay on the enhanced.
Matthew Lee Kaplan: Yeah, just to stay on the enhanced Phase 3B switching trial, can you provide a little bit more information in terms of what we should be looking for from that data as it's released? at ACTRIMS and at other conferences this year? Matt, it's like a day or two away.
Matt Kaplan: Yeah good morning.
Matt Kaplan: Just to stay on the enhance phase III Dean switching trial can you provide a little bit more information in terms of what we should be looking for from that data all of its assets release call.
Speaker Change: So all those actions on a later.
Speaker Change: Later conferences this year.
Speaker Change: Matt It's like a day or two away really want me to give you if at all the way.
Michael S. Weiss: Really? You want me to give it all the way? Yeah, I mean, look, what are we trying to accomplish? I think it's a fair question. So, you know, we want to make it as easy as possible for folks to be able to switch seamlessly from another CD20 on to pre-OMV. It's, yeah, no secrets.
Matt Kaplan: Yeah, I mean like so what are we trying to accomplish.
Speaker Change: A fair question.
Speaker Change: You know, we want to make it as easy as possible for folks to be able to switch seamlessly from another CD 20 on soup Ravi.
Speaker Change: It's no secret doing extra doing an extra four hour infusion.
Michael S. Weiss: Doing an extra doing an extra four hour infusion is not the ideal situation for that patient population who are already B cell depleted. So, the goal is, step one is, can you safely take a patient who is on another drug, they're B cell depleted, and put them on another CD20 without sort of this initial conditioning with a regimen that we have for the starting dose? So, that's step one. Safety is of utmost importance, and that's what we wanted to do. Partly, we wanted to get that done, too, because we had heard in the field that people were just switching people straight through to the one-hour break. So we wanted to make sure we had safety.
Speaker Change: Is it not the ideal situation for that patient population already.
Speaker Change: Our T cell depleted.
Speaker Change: So the goal is step one is can you safely take a patient who's on another drug and other b cell depleted and put them on another CD 20 without sort of this initial conditioning regimens that we have today the starting dose.
Speaker Change: So that's step one so safety is the utmost importance to us.
Speaker Change: Is it a due partly we wanted to get it to get that done because we had heard in the field that people were just switching people straight through.
Speaker Change: Two one hour of Ramsey.
Speaker Change: So we wanted to make sure we have safety. The next part is the you know.
Michael S. Weiss: The next part is, look, you know, I think we would love to get it into the label. You know, we are eliminating 150 milligrams of drug, so there will be an efficacy question. I don't think it's a material efficacy question, but it has to be answered. So I think as we move forward, you know, one question we should ask ourselves is, what are we looking for? We need to make sure it's safe and well-tolerated to switch people directly to a one-hour pre-emptive from another CD20, and if there's any signal that we'd somehow be losing some activity by eliminating the 150 milligrams.
Speaker Change: I think they would.
Speaker Change: Love to get it into the label.
Speaker Change: We are eliminating 150 milligrams of drug so there will be an efficacy question I don't think it's material.
Speaker Change: I forgot sorry efficacy question, but.
Speaker Change: But it has to be answered so I think as we move forward you know one you know what.
Speaker Change: Are we looking for make sure it's safe and well tolerated to switch people directly to a one hour reality from from another CD 20.
Speaker Change: And if there's any signal that we somehow be losing some activity by eliminating the 150 milligrams.
Michael S. Weiss: So, I think we're still probably in the safety phase of this trial, so I think at ECTRIMS, we'll be looking for more safety information. Probably, by the time we get to ECTRIMS, we should be able to have some additional efficacy again. It's single-arm, so the efficacy information will be, you know, pretty straightforward: looking at MRIs and just making sure that there's nothing going on that would be surprising.
Speaker Change: So I think we're still probably in the in the safety phase of.
Speaker Change: This trial, so we didn't get actions, we'll be looking for more safety information probably by the time, we get to at terms, we shouldn't be able to have some some additional efficacy you get it.
Speaker Change: Arm, so the efficacy information will be.
Speaker Change: Pretty straightforward looking at that right and just making sure that there's nothing going on that that would be surprising.
Speaker Change: Okay. That's really helpful. Thank you and then.
Michael S. Weiss: And then, in terms of your plans for beyond the outside of the MS opportunity, can you help us think about how you prioritize the different indications that you're potentially looking at? Yeah, I mean, I think we want to get started probably somewhere in the RA lupus arena with it. I can't promise that that's what's going to happen, but we do think that there's an interesting opportunity. It also will dovetail nicely as we look to get Azure Cell and some of those indications as well. There's a nice synergy of clinical resources. So that's an angle that we're looking at, but I can't promise that as the year goes on, we may have additional thoughts, and we may start someplace else. But we do believe that Brionvi is designed well for large market indications.
Speaker Change: In terms of your plans for beyond being outside of the U S opportunity.
Speaker Change: Can you help us think about how you prioritize the different indications that you're potentially looking at.
Speaker Change: Yeah.
Speaker Change: Yeah, I mean, I think look we wanted to get started.
Speaker Change: Probably somewhere in the R E. This arena.
Speaker Change: With within that cant promise that that's what's going to happen, but we do think that there's an interesting opportunity. It also will dovetail nicely as we as we look to get either selling some of those indications as well, there's a nice synergy of our clinical resources. So that's.
Speaker Change: That's a that's an angle that we're looking at but I can't promise as the year goes on we may have.
Speaker Change: Additional thoughts and then they start someplace else, but we do believe that.
That really is designed well for large market indications and right behind it as yourselves designed Furthermore.
Michael S. Weiss: And right behind it, Azure Cell is designed for the smaller, thicker kind of patient populations, potentially within the same indication. And then lastly, in terms of the recent patents that you announced, can you provide us with some more detail in terms of what they cover? and providing protection after it was at 2040. Uh, yeah, I'm gonna... There's a lot of detail in those patents, but I think that some sense is that, in addition to a new composition of matter patent that covers the glycosylation profile of Brion-V, plus some use patents within that, we feel good about the 2042 patent protection. So we feel that we've got a really nice runway here, but the patents are issued, they're out there, people can read them, but the over Composition of Matter, plus some used patents.
Speaker Change: The smaller sicker kind of patient population potentially within the same indications.
Speaker Change: Okay, Great Great and then lastly in terms of.
Speaker Change: The recent patents that you're in now.
Speaker Change: Biosimilar detail in terms of what they cover and.
Speaker Change: And providing more protection I'll call. It was a 2022.
Speaker Change: Yeah.
Speaker Change: There's there's a lot of detail on those patents, but I think there's some substances that are in addition to new composition of matter patent that covers the.
Speaker Change: Like that go like oscillation profile of Brown V plus some use patents are within that.
Speaker Change: We feel good about the 2042 patent protection so that we can fill.
Speaker Change: That we've got a really nice runway here.
Speaker Change: But the.
Speaker Change: These are issues that are out there and people can read them, but the overriding concept is that it's a.
Speaker Change: Composition of matter plus some use patents.
Michael S. Weiss: 2042 is a nice new place for our exclusivity to run to. All right. Thanks. Thanks a lot.
Speaker Change: 2042 is a nice new.
Speaker Change: Pleasure exclusivity to rupture.
Speaker Change: Perfect. Thanks, a lot.
Eric William Joseph: Yep. From Eric Joseph of J.P. Morgan, please go ahead. Hi guys, this is Noah on behalf of Eric.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: From Eric Joseph of J P. Morgan. Please go ahead.
Speaker Change: Yeah.
Speaker Change: Hi, guys. This is Noah on for Eric Thanks for taking our question or.
Unknown Speaker: Thanks for taking our question. The question is, with regard to subcube Brion-V, how important to drive uptake would it be to demonstrate efficacy via relapse rate compared to demonstrating comparability on biogas? So, the current competitor that's moving from their IV to sub-Q did a bioequivalence study. We're hoping that we'll be able to follow a similar pathway, so I don't think we're going to need to do a full efficacy study to bring the sub-Q forward, but that will definitely be subject to more conversations with the FDA. But as of now, the competitor sub-Q that's moving from IV has conducted a bioequivalence study, and we think that's an appropriate pathway. You got it. Thank you. The next question is coming from Prakhar Agrawal of Cantor Fitzgerald. Please go ahead.
Noah: My question is.
Noah: In regard to Q3 on the.
Noah: How important.
Noah: To drive uptake would it be to.
Noah: Demonstrate efficacy relapse rate.
Noah: Compared to demonstrating comparative bioequivalence.
Noah: Yes.
Noah: Okay.
Noah: So the current competitor that's moving from their IV to subcutaneous Bioequivalence study.
Noah: We're hoping that we'll be able to follow a similar similar pathway.
Noah: So I don't think we're going to need to do a full efficacy study.
Noah: To bring this up to forward.
Noah: But that would be definitely subject to more conversations with the FDA, but.
Noah: As of now that the competitor subdue that's moving from IV.
Noah: Conducted a bioequivalence setting we think that's.
Noah: Inappropriate pathway.
Speaker Change: Thank you.
Speaker Change: Got it.
Speaker Change: Thank you. The next question is coming from <unk> <unk> of Cantor Fitzgerald. Please go ahead.
Speaker Change:
Prakhar Agrawal: Hi, good morning and congratulations on the progress and thanks for taking my question. So number one, Adam, you said OneQ is tracking at the top end of the guidance range. So maybe if you could give some more details on the January and February trends, where is the demand growth coming from in terms of patient segments, as well as physician segments, academic courses, and communications. Hi, Prakhar.
Cantor Fitzgerald: Hi, good morning, and congrats on the progress and thanks for taking my question. So number one Adam you said <unk> is tracking at the top end of the guidance range. So maybe if you can give some more details on the January and February trends, whereas the demand growth coming from in terms of patient segments as well as physician segment.
Speaker Change: Academy courses community.
Speaker Change: Yes.
Adam Waldman: Thanks for the question. I'm not going to get into too many details beyond what I said in the prepared remarks. We got off to a really strong start this quarter.
Adam Waldman: Yeah, Hi, <unk>. Thanks for the question.
Speaker Change: I'm not going to get into too many details.
Adam Waldman: Beyond what I said in the prepared remarks.
Speaker Change: We got off to a really strong start to the quarter.
Adam Waldman: And as I said, you know, we're feeling really good about our guidance to the higher end of that range. And then, you know, any other details we'll discuss on the next quarter call. Got it.
Adam Waldman: And as I said.
Adam Waldman: We're feeling really good about our guidance to the higher end of that range.
Adam Waldman: And then any other details will discuss on the next quarter call.
Speaker Change: Got it and.
Adam Waldman: Do you have a sense of what the split is between academic courses and community patient segments for BMV and how do you expect that to trend over time? Sure. So in the beginning of the year, as I mentioned, it was probably 60-40 private practice to academics. In the most recent quarters, it's more 50-50, academic to private practice, and we are seeing, as I mentioned in the remarks, growth coming from academic centers in the latter half of the year and especially in the fourth quarter. Got it. And lastly, What percentage of patients who are getting a prescription actually end up getting the infusion? Do you have any additional details on the trend there? And what's the time lag between getting a prescription and getting an infusion right now, and how does it track relative to after?
Speaker Change: Do you sort of do you have a sense of what's the split of Academy courses community patient segments for bringing me on how do you expect that to trend over time.
Speaker Change: Sure so in the beginning of the year.
Speaker Change: I mentioned it was probably 60 40 private practice to academics.
Speaker Change: In the most recent quarters, it's more 50 50.
Speaker Change: Academic the private practice and we are seeing as I mentioned in the remarks.
Speaker Change: Growth coming from academic centers.
Speaker Change: In the latter half of the year and especially in the fourth quarter.
Speaker Change: Got it and lastly.
Speaker Change: What percentage of patients who are getting a prescription actually end up getting the infusion do you have any.
Speaker Change: Some details on the on the trend there and what's the time lag between getting a prescription to getting an infusion right now and how does it track relative to OCA Lewis.
Adam Waldman: Yeah, so the conversion rate we have, it's still pretty early. And we have not given a number on that. It's, It's encouraging, but we haven't given a specific number, and perhaps in future calls, we'll look at it, but we still think it's very early to be giving. And then, Prakhar, can you repeat the second part of that question? Alright, so what's the time lag between prescription and getting the infusion and how does that trend versus Oculus?
Speaker Change: Yes, so the conversion rate we have it's still it's still pretty early and we have not given a number on that.
Speaker Change: It's.
Lewis: It's encouraging but we haven't given a specific number and perhaps in future calls, we'll look at it but we still think it's very early to be giving that number.
Speaker Change: And then for car can you repeat the second part of that crossing.
Speaker Change: So what's the time lag between.
Speaker Change: A prescription and getting the infusion and how does that trend versus locals.
Adam Waldman: Yeah. So I think of what I've said in the past, it's about a six-week timeframe from enrollment into the hub to the first and, Approximately, and from what we understand and from what we think, it's very similar to what you see with Ocrevus. There are a lot of things you can control in that process, and there are things that are outside your control.
Speaker Change: Yeah.
Speaker Change: So.
Speaker Change: I think what I've said in the past, it's about a six week.
Speaker Change: Timeframe from enrollment into the hub into the first infusion approximately and from what we understand and from what we.
Speaker Change: Very similar to what you see with OCA is a there.
Speaker Change: There are a lot of things you can control on that processing like things that are outside your control.
Adam Waldman: We continue to see a trend in that direction, we continue to shorten it over time, and so we'd like to see that trend, and we think it's very much in line with what the competitors are doing. Thank you, and good night for the quarter. Thanks. Thank you. Our final question today is coming from Mayank Mamtani of B. Riley Securities. Please go ahead. Thank you so much. This is actually William Wood.
Speaker Change: We continue to see a trend in the direction.
Speaker Change: And we continue to shorten it overtime and so we we'd like to see that trend and.
Speaker Change: And we think it's very much in line with what's the competitor product.
Speaker Change: Thank you and congrats on the quarter.
Speaker Change: Thanks.
Speaker Change: Thank you our final question today is coming from.
Speaker Change: I'm Tony of B Riley Securities. Please go ahead.
Tony: Thank you. So much this is actually a win win on for my own timing.
Mayank Mamtani: I'm from Mayank Mamtani. Congratulations on the past year and thank you for taking our questions. In terms of the cash and the OPEX burn for 2024, how should we be thinking about the spend allocation between your trials and what's been factored so far into the sub-Q trial? And then additionally, on the sub-Q trial, do you have any idea of the frequency of administration or the kind of device that you'll be using for the formulation? And then there was one follow-up.
Tony: Congratulations on the past year and thank you for taking our questions.
Tony: In terms of the cash and the Opex burn for 2024, how should we be thinking about the spend allocation between your trials and what's been factored so far into the sub Q trial and then additionally on the sub Q trial.
Tony: [laughter].
Tony: Do you have any view of frequency of administration or the kind of device that you'll be using for the formulation and then one follow up thank you.
Michael S. Weiss: Thank you. Yeah, so on the subcube, you know, we don't know yet in terms of the frequency of dosing. I think part of that is just going to be figuring out what the conversion is between the two from IV to subcube.
Speaker Change: Yeah, so on the the sub Q.
Speaker Change: Don't know yet in terms of the.
Speaker Change: Frequency of dosing I think part of that is just can be let's let's look at.
Speaker Change: What the conversion is between the two from IV to sub Q.
Michael S. Weiss: And from there, we'll be able to design the appropriate dosing interval. Our goal, obviously, we know what the goalposts are. We've got once a month from one of the subcube products, and the other is once every six months with a pretty clunky product, as far as we can tell.
Speaker Change: And from there, we'll be able to design that.
Speaker Change: The appropriate.
Speaker Change: Dosing interval our goal, obviously, but we know what the goalposts are we've got a.
Speaker Change: Once a month from one of the subsea products and the other is once every six months.
Speaker Change: Were they pretty clunky.
Speaker Change:
Speaker Change: Product as far as we can tell and so somewhere.
Michael S. Weiss: And so somewhere in between, we think we'd be very successful. So we're going to try to get there. We won't know if we can until we put the material into people and see how it does and see how they react to it.
Speaker Change: We're in between we think we'd be very successful. So we're going to try to get there. We won't know if we can until we put the put the material into two people.
Speaker Change: How does and see how they react to it.
Sean A. Power: Hi, and on the OPEX guidance, obviously, we've guided 250 in OPEX for 24. But we haven't provided a detailed breakdown of how that shakes out. But everything that Mike and the team discussed today is obviously included in that 250 guidance number. I appreciate that. And then just one last question. You've obviously reported multiple new patents providing protection into 2042, including COM, as you just noted, as well as the recent launch in the EU. How should we be thinking about this in terms of potential external parties viewing these events and maybe spurring additional interest in TG? Yeah, our goal is to build our business. We're not too worried about external parties. I think if you're referring to external parties, me being investors, I would hope they'd be updating their models to understand the significance of patent protection through 2042 and what that means to the overall NPV of the stock.
Speaker Change: And on the Opex guidance.
Speaker Change: We had guided to 50.
Speaker Change: Next for 'twenty four we haven't provided.
Speaker Change: The detailed breakdown of how that shakes out but.
Speaker Change: Everything that.
Speaker Change: And the team just left today is obviously included in that 250.
Speaker Change: Guidance number.
Speaker Change: I appreciate that and then just one last question.
Speaker Change: You, obviously, you've reported multiple new patents, providing protection into 'twenty 42, including Com.
Speaker Change: Noted as well as the recent launch and do you how should we be thinking about this in terms of potential external parties doing these events and maybe spurring additional interest N T D.
Speaker Change: Yeah. Our goal is to build our business, we're not too worried about external parties I think if you're referring to external parties me being investors I would I would hope they'd be updating their models to understand.
Speaker Change: The significance of patent protection through 2042, and what that means to the overall NPV of the SaaS.
Michael S. Weiss: Other outside parties I'm not too worried about. Appreciate that, and thank you for taking our questions. Great, thank you. Thank you. At this time, I'd like to turn the floor back over to Mr. Weiss for closing. Great, and thank you. And again, thanks to everyone for joining us this morning. As reported, we had a great launch year, and year two, while early, is taking shape, and we're excited about our target guidance for this year of $220 to $260 million in U.S. net sales revenue. Our pipeline and lifecycle management activities are in full swing, and we believe these activities could translate into significant future value for TG, and our recent patent issuance will ensure a long runway to explore the full potential of Reonvate.
Speaker Change: Other outside parties I'm not too worried about.
Speaker Change: I appreciate that and thank you for taking our questions.
Speaker Change: Great. Thank you.
Michael Sean Weiss: Thank you at this time I'd like to turn the floor back over to Mr. Weiss for closing comments.
Weiss: Great and thank you and again, thanks to everyone for joining us this morning.
Michael Sean Weiss: Yeah.
Weiss: As reported we had a great launch year and year two while early is taking shape and we are excited about our target guidance for this year of $220 million to $260 million in U S. Net sales revenue.
Weiss: Our pipeline and lifecycle management activities are in full swing and believe these activities could translate to translate into significant future value for TG and.
Weiss: In a recent patent issuance will ensure a long runway to explore the full potential of reality.
Michael S. Weiss: Finally, I want to thank again the whole TG team for their dedication to serving the MS community and for their incredible efforts on behalf of TG. Hope everyone has a very nice day. Ladies and gentlemen, thank you for your participation. This concludes today's... You may disconnect your lines at this time or log off the webcast and enjoy the rest of the event. Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
Weiss: Finally, I want to thank again, the whole T. G team for their dedication to serving the MS community and for their incredible efforts on behalf of T. J.
Weiss: Hope everyone has a very nice day.
Speaker Change: Ladies and gentlemen, thank you for your participation. This concludes today's event you may disconnect. Your lines at this time or log off the webcast and enjoy the rest of your day.
Weiss: Yeah.
Weiss: Yeah.
Weiss: Okay.
Weiss: Yeah.
Weiss: Yes.