Q4 2023 Kiniksa Pharmaceuticals Ltd Earnings Call
Okay.
Operator: Good day, and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a lesson only mode.
Good day, and thank you for standing by welcome to the <unk> Pharmaceuticals fourth quarter and full year 2023 earnings conference call.
This time, all participants are in a listen only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one one on your telephone. You will then hear an automated message advising you that your hand is raised.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need a press star one on your telephone you will then hear an automated message of making you. Your hand is raised to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker.
Operator: To withdraw your question, please press star one one again. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Rachel Frank, head of investor relations. Please go ahead.
Rachel Frank head of Investor Relations. Please go ahead.
Rachel Frank: Thank you, operator. Good morning, everyone, and thank you for joining Kiniksa's call to discuss our fourth quarter and full year 2023 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investor section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with the introduction.
Thank you operator, good morning, everyone and thank you for joining this call to discuss our fourth quarter and full year 2023 financial results and recent portfolio execution.
A press release highlighting these results can be found on our website under the investors section.
So the agenda, our Chief Executive Officer, Don Casey will start with the introduction.
Sanj K. Patel: Ross Mote, our Chief Commercial Officer, will provide an update on our Arkliffs commercial execution. John Paolini, our Chief Medical Officer, will review the Abbey's Pruvart program in recent Phase 2 data. And Mark Burgosa, our Chief Financial Officer, will review our fourth quarter and full year 2023 financial results. And finally, Sanj will return for closing remarks and to kick off the Q&A session, during which Evan Tesari, our Chief Operating Officer, will also be on the line. Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. A review of such statements and risk factors can be found on this slide, as well as under the caption, risk factors, contained in our SEC filing. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements except as required by law. Thanks, Rachel. And good morning, everyone.
Both our chief commercial officer, who will provide an update on our commercial execution, John Paolini, Our Chief Medical Officer will review the Abbvie prove out program.
Data and Mark <unk>, our Chief Financial Officer will review, our fourth quarter and full year 2023 financial results.
Finally, I will return for closing remarks is to kick off the Q&A session or whichever sorry, our chief operating officer will also be on the line.
Before getting started please note that we will be making forward looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements argued such statements and risk factors can be found on this slide as well under the caption risk factors contained in our SEC filings each.
These statements speak only as of the date of this presentation and we undertake no obligation to update such statements.
With that I'll turn it over to songs.
Thanks, Rachel and good morning, everyone I'll review, our fourth quarter and full year 2020, we financial results today.
Sanj K. Patel: I'll review our fourth quarter and full year 2023 financial results today. Consistent execution in both commercial and clinical settings throughout 2023 has put us in a strong position to further advance our business in the year ahead. The Arkellys commercialization continues to see meaningful growth with Q4 net product revenue of $71.2 million, putting us at $233.2 million for the past year.
Consistent execution in both commercial and clinical settings throughout 2023 is causing a strong position to further advance our business in the year ahead.
The okaloosa commercialization continues to see meaningful growth with Q4 net product revenue of $71 2 million, putting us at $233 2 million for the past year.
Sanj K. Patel: We're very encouraged with the commercial execution to date, which is underscored by growing prescriber adoption and increased duration, as well as continued high patient satisfaction and payer approvals. Moving forward, we remain highly focused on reaching even more patients and driving long-term sustained growth with our. Looking to the year ahead, we have guided to arc-less sales of between $360 to $380 million, which would represent roughly 59% year-over-year growth at the midpoint. In terms of our pipeline, we recently provided data from the first three cohorts of the Abiprobar Phase 2 Rheumatoid Arthritis trial, and data from cohort 4, the monthly dosing cohort, are expected in April.
We're very encouraged with the commercial execution to date, which is underscored by growing prescriber adoption and increased duration as well as continued high patient satisfaction and payer approvals.
Moving forward, we remain highly focused on reach even more patients and driving long term sustained growth with alkylation.
Looking to the year ahead, we've guided to Arcalis sales of between 362.
$380 million, which would represent roughly 59% year over year growth at the midpoint.
In terms of our pipeline. We recently provided data from the first three cohorts of the abbey prove out phase III rheumatoid arthritis trial.
<unk> data from cohort for the monthly dosing cohort are expected in April.
Sanj K. Patel: Data from this cohort will provide additional dosing insights and are intended to inform future trial design. Based on the data we have evaluated to date, we now expect to advance the asset into a Phase 2B trial in a new indication, which will also be announced in April. This next step is already included in our current cash one way guidance. And with that, I'll turn it over to Ross to review our commercial execution. Ross.
Data from this cohort will provide additional dosing insights and our intended to inform future trial design.
Based on the data we've evaluated to date, we now expect to advance the asset into a phase two b trial in a new indication, which will also be announced in April.
This next step is already included in our current cash runway guidance.
And with that I'll turn it over to walk to review our commercial execution Ross. Thank you so much.
Ross Mote: Thank you, Sanj. I am happy to share further details on our fourth quarter and full year 2023 commercial performance, as well as our key priorities for the long-term growth of Arkelyst during the current period. In the fourth quarter, Arclis Net Revenue grew to $71.2 million, representing nearly 80% growth versus Q4 of 2020. This resulted in $233.2 million for the full year 2023, which is a 90% year-on-year growth. This revenue growth was driven by our strategy to increase the awareness of recurrent percolators and alkalis across the U.S. By the end of 2023, more than 1,700 unique prescribers had written a prescription for Alkalis since launch, with approximately 24% of those having prescribed for two or more. Additionally, we've continued to observe robust payer approval rates of greater than 90% for all completed, and patient compliance remains greater than 85% even with the longer durations of therapy.
I'd like to share further details on our fourth quarter and full year 2023 commercial performance as well as our key priorities for the long term growth of Barclays and recurrent pericarditis.
In the fourth quarter <unk> net revenue grew to $71 $2 million, representing nearly 80% growth versus Q4 of 2022.
This resulted in $233 2 million for the full year 2023, which is a 90% year on year price.
This revenue growth was driven by our strategy to increase the awareness of recurrent pericarditis and uplifts across the U S.
End of 2023 more than 1700 unique prescribers have written a prescription for <unk> since launch with approximately 24% of days, having prescribed for two or more patients.
Additionally, we've continued to observe robust payer approval rates of greater than 90% of all completed cases and patient compliance remains greater than 85%, even with the longer durations of therapy.
Ross Mote: As of the end of 2023, the average total duration of therapy had increased to approximately 23 months, and our focus, through education and increasing familiarity with art, is to continue to better align real-world prescriber practice with the natural history of recurrent pericarditis, where the data show patients with two or more recurrences suffer with the disease for a median of three years.
As of the end of 2023, the average total duration of therapy has increased to approximately 23 months and our focus through education and increasing familiarity with Atlas is to continue to better align real world Prescriber practice with the natural history of recurrent pericarditis.
The data show patients with two or more of a conscious suffered with the disease median of three years.
Ross Mote: Across the business, we continue to be thoughtful and data-driven with the investments in our commercial infrastructure, and we're focused on prioritizing continued double-digit revenue growth and increasing collaboration profit year on year. Since launch, we've continued to activate an ever-growing prescriber base, with anywhere from between 100 to 250 new first-time prescribers writing an Alkalys prescription each month. As we know, recurrent pericarditis is a rare, flaring disease with few high-volume specialty disease centers managing the disease, which means most prescribers can go an extended period of time before identifying their next patient.
Across the business, we continue to be thoughtful and data driven with the investments in our commercial infrastructure and we're focused on prioritizing continued double digit revenue growth and increase in the collaboration profit year on year.
Yes.
Since launch we've continued to activate an ever growing prescriber base with anywhere from between 100 to 250, New first time prescribers, writing it off list prescription each quarter.
As we know recurrent pericarditis.
Flaring disease with few.
High volume specialty disease centers, managing the disease, which means most prescribers could go an extended period of time until identify and then next patients encouragingly as time passes since the initial prescription and further patient. So identified we've seen a steady growth in prescribers, who have written too.
Ross Mote: Encouragingly, as time passes since the initial prescription and further patients are identified, we've seen a steady growth in prescribers who have written two or more prescriptions. Then, as you can see on the right-hand side of this slide, over time, we also see a steady increase in the number who have written for three, four, or more patients. Our focus continues to be on a dual strategy of continuing to grow the total prescriber base while increasing the depth of prescribing. To do this, we're very focused on targeting where we believe the multiple recurrent patients are, as well as ensuring that both physicians and their patients have a positive experience when initiating ARC-LIST and throughout the course of the disease. Additionally, at the end of 2023, greater than 40% of all new prescriptions within the year came from repeat prescribers, demonstrating an increasingly meaningful contribution from this steadily growing group. We previously announced that as of the end of Q4, approximately 9% of the target population of 14,000 multiple recurrent patients were actively on Alkalys therapy. This represents approximately 80% annual growth versus the 5% penetration that we announced as of the end of 2022.
More patients than as you can see on the right hand side of this slide over time, we also see a steady increase in the number who have written for three four or more patients.
Our focus continues to be on a dual strategy of continuing to grow out of the total prescriber base, while increasing the depth of prescribing.
To do this we're very focused on targets and while we believe the multiple of the current patients.
As well as ensuring that both physicians and patients have a positive experience, while initiating uplift and throughout the course of the disease.
Additionally, at the end of 2023 greater than 40% of all new prescriptions within the year came from repeat prescribers demonstrates an increasingly meaningful contribution from the steadily growing great of physicians.
We previously announced that as of the end of Q4, approximately 9% of the target population of 14000 multiple recurrent patients while actively on our Atlas therapy.
This represents approximately 80% annual growth versus the 5% penetration that we announced as of the end of 2022.
Ross Mote: This underscores the progress we've made since launch, as well as the significant opportunity we have in the years ahead to drive much greater growth into the patient population that we can support with us. To address the opportunity ahead, our strategy is to accelerate our reach and frequency with the top-tier healthcare professionals, as well as interact with many of the long-tailed physicians, making up around 11,000 healthcare professionals in total, who we believe look after the majority of patients suffering from We're nearly three years post-approval of Alkalyst for the treatment of recurrent pericarditis, and our commercial execution has been robust, driving net revenue growth every Earlier this year, we announced that we expect our continued execution to generate full year 2024 net revenue of between $360 and $380 million. With that, I'll hand over to John to discuss our group. John.
This underscores the progress we've made since launch as well as the significant opportunity. We have in the years ahead to drive much greater clarity into the patient population that we can support with office.
To address the opportunity ahead, our strategy is to accelerate our reach and frequency with a top tier healthcare professionals as well as interact with many of the long tired of physicians, making up around 11000 health care professionals in total we believe the cost of the majority of patients suffering from the disease.
We're nearly three years post approval of <unk> for the treatment of recurrent pericarditis and our commercial execution and speed bypass.
Driving net revenue growth every single quarter since launch and providing increasing collaboration profitability.
Earlier this year, we announced that we expect.
<unk> execution to generate full year 2024, net revenue of between 360 and $380 million.
With that I'll hand over to John to discuss after three months.
John F. Paolini: Thanks, Ross. As a reminder, the Phase 2 proof of concept trial of Abiprobard and rheumatoid arthritis is designed to evaluate the efficacy, dose response, pharmacokinetics, and safety of chronic subcutaneous dosing over a duration of 12 weeks. We announced data from the first three cohorts of the trial earlier this year, and Abby Prubart showed meaningful clinical effects in each of those cohorts, in Cohorts 1 and 2, the PK lead-in. Multiple doses of Aviprubart were well-tolerated and enabled the proof-of-concept portion of the study. Cohort 3 of the trial achieved its primary efficacy endpoint change from baseline in DAS28 CRP versus placebo with statistical significance in the 5 milligram per kilo weekly dose group. However, the 5 milligram per kilo bi-weekly dose group did not achieve statistical significance, although a higher than expected placebo rate was observed.
Yes.
Thanks Ross.
As a reminder, the phase II proof of concept trial of <unk> in rheumatoid arthritis is designed to evaluate the efficacy dose response pharmacokinetics and safety of chronic subcutaneous dosing over a duration of 12 weeks, we announced data from the first three cohorts of the trial earlier this year and Abbvie prove our showed meaningful.
Clinical effect in each of those cohorts.
In cohorts, one and two the PK read in multiple doses of Abbvie prove art were well tolerated and enables the proof of concept portion of the study.
Cohort three of the trial achieved its primary efficacy end point change from baseline in <unk> 2008, CRP versus CMO with statistical significance in the five milligram per kilo weekly dose group.
<unk> five milligram per kilo biweekly dose group did not achieve statistical significance, although a higher than expected placebo rate was observed.
John F. Paolini: Abhi Prubark was also well-tolerated in this cohort. As we have continued analyzing the data package from the first three cohorts, we are confident that Abiprobard is a highly active and well-tolerated molecule and has strong potential to reduce autoantibody production, as evidenced by the greater than 40 percent reduction in rheumatoid factor observed at both cohort three dose levels. The Phase 2 study is continuing with a fourth cohort that advances the dosing regimen from weight-based dosing to fixed milligram dosing using the 400 milligram every four-week dose level. We did that to achieve plasma concentrations intermediate between the clinically active 2 mg per kilo biweekly and 5 mg per kilo biweekly dose groups, and which are projected to be an order of magnitude above what is necessary to achieve complete receptor occupancy and TDAR suppression, but at a potentially more clinically relevant dosing interval.
<unk> was also well tolerated in this cohort.
As we have continued analyzing the data package from the first three cohorts. We are confident that abbvie prove or it is a highly active and well tolerated molecule and has strong potential to reduce auto antibody production as evidenced by the greater than 40% reduction in regulatory factor observed in both cohorts three dose levels.
The phase III study is continuing with a fourth cohort, which advances the dosing regimen for weight based dosing to fixed milligram dosing using the 400 milligram every four week dose level, we did that to achieve plasma concentrations intermediate between the clinically active two milligram per kilo biweekly and.
Five milligram per kilo biweekly dose groups, and which are projected to be in order of magnitude above what is necessary to achieve complete receptor occupancy and <unk> suppression, but at a potentially more clinically relevant dosing interval.
John F. Paolini: Cohort 4 maintains the placebo-controlled efficacy and safety endpoints from Cohort 3, with change from baseline and DAS-28-CRP at Week 12 as the primary efficacy endpoints. As Sanj mentioned, we continue our preparations for further phase two development and a new indication with Abbey Prubar. And, as the data from Cohort 4 are added to the totality of the dataset, informing PK-PD relationships, we plan to finalize future dosing regimens that we will take forward in development. We will have more to say on that in April, in conjunction with the Cohort 4 data. With that, I will turn it over to Mark to cover our financials. Thanks, John.
Cohort four maintains the placebo controlled efficacy and safety endpoints from cohort three with change from baseline in <unk> 2008, CRP at week 12, as the primary efficacy endpoint.
As Andrew mentioned, we continue our preparations for further phase II development, and a new indication with Abbvie Pru bear and as the data from cohort four are added to the totality of the data set informing PK PD relationships, we plan to finalize future dosing regimens that we will take forward in development.
We will have more to say on that in April in conjunction with the cohort four data.
With that I will turn it over to mark to cover our financials.
Mark Burgosa: Over the next few minutes, I'll walk you through our fourth quarter and full year 2023 financial performance. You can find our detailed financial information in today's press release, and I'd like to call your attention to a few items. First, total revenue for the fourth quarter was $83.4 million, including RplusNet product revenue of $71.2 million, representing nearly 80% growth year-over-year, and collaboration revenue of $12.2 million, driven primarily by the recognition of a $10 million development milestone for a second new indication under the Genentech license agreement for Vixor OMS. Total revenue for the full year 2023 was $270.3 million, including ArcLisNet product revenue of $233.2 million, representing approximately 90% year-over-year growth, and collaboration revenue of $37.1 million from the Genentech license.
Thanks, John.
Over the next few minutes I'll walk through our fourth quarter and full year 2023 financial performance.
You can find our detailed financial information in today's press release and I will.
Like to call your attention to a few items.
First total revenue for the fourth quarter was $83 4 million.
Including our <unk> net product revenue of $71 $2 million, representing nearly 8% growth year over year and collaboration revenue of $12 2 million driven primarily by the recognition of a $10 million development milestone for a second new indication under the genetic license agreement perfect zero on that.
Total revenue for the full year 2023 was 273 billion.
Including Arcalis net product revenue of $233 2 million, representing approximately 90% year over year growth in collaboration revenue of $37 1 million from the genetic license agreement.
Mark Burgosa: Regarding the $10 million development milestone from Genentech recognized as collaboration revenue in the fourth quarter, the cash was received in January and will be captured in our first quarter 2024 cash balance. To date, we have recognized over $124 million of the $125 million earned under the Genentech license agreement, and we expect to realize the small remaining balance over the next two quarters. Second, Arklets collaboration operating profit was $33.9 million in the fourth quarter, representing over 125% growth year-over-year and leading to collaboration expenses of $16.9 million.
Regarding the $10 million development milestone from Genentech recognized as collaboration revenue in the fourth quarter. The cash was received in January and will be captured in our first quarter of 2024 cash balance.
To date, we have recognized as collaboration revenue over $124 million of the 125 million earned under the genetic license agreement, we expect to realize the small remaining balance over the next two quarters.
Second Arkla's collaboration operating profit was $33 9 million in the fourth quarter, representing over 125% growth year over year, and leading to collaboration expenses of $16 9 million.
Mark Burgosa: Our collaboration operating profit for the full year 2023 was $113 million, representing over 210% year-over-year growth and leading to collaboration expenses of $56.5 million. Third, higher cost of goods sold and collaboration expenses, both of which are largely driven by ARCWLIS revenue growth, as well as the advancement of the Abby Prubark Phase II trial in rheumatoid arthritis and investment related to ARCWLIS commercialization through year-over-year operating expense growth for both the fourth quarter and full year 2023. Fourth, net income for the fourth quarter and full year 2023 was $25.2 million and $14.1 million, respectively, aided by both collaboration revenue as well as the treatment of our non-cash deferred tax assets. Lastly, we received $35 million in cash from the Genentech License Agreement in 2023. This contributed to a net cash flow of approximately $16 million for the year and an ending cash balance of $206.4 million.
Arcalis collaboration operating profit for the full year, 2023 was $113 million, representing over 210% year over year growth and leading to collaboration expenses of $56 5 million.
Third higher cost of goods sold and collaboration expenses, both of which are largely driven by <unk> revenue growth as well as the advancement of the <unk> phase III trial in rheumatoid arthritis, and investment related to <unk> commercialization drove year over year operating expense growth for both the fourth quarter and full year two.
23.
Net income for the fourth quarter and full year, 2023 was $25 2 million and $14 $1 million, respectively. Aided by both collaboration revenue as well as the treatment of our noncash deferred tax assets.
Lastly, we received $35 million in cash from the genetic license agreement in 2023. This contributed to net cash flow of approximately $16 million for the year and an ending cash balance of $206 4 million.
Sanj K. Patel: We continue to expect these reserves, as well as strong Arkloss commercial execution, to fund our current operating plan into at least 2026. With that, I'll turn the call back to Sanj for closing. Thanks Mark. As you heard this morning, we expect 2024 to be another exciting year for Kiniksa.
We continue to expect these reserves as well as strong arcalis commercial execution to fund our current operating plan into at least 2027 and with that I'll turn the call back to Sam for closing remarks.
Thanks, Mark as you've heard this morning, we expect 2024 to be another exciting year for <unk>.
Our execution in 2023.
Sanj K. Patel: Thank you very much, and Advancing Our Portfolio in the Year Ahead. Importantly, we expect our robust commercial performance to meaningfully contribute to our strong financial position and our ability to drive growth across the business. And as Mark said, our current cash position provides one way to fund our operations, including a new indication for Abbey Prupath, into at least 2027. Ultimately, we're determined to continue to provide life-changing medicines for patients and build sustainable value, and we believe we are strategically positioned to do that. We want to thank all of you for your time today, and I'll hand it back to the operator for any questions. Thank you. As a reminder, if you would like to ask a question at this time, please press star 1 1 on your phone and wait for your name to be announced. To withdraw your question, please press star 1 1 again.
On the path to continued commercial success.
And advancing our portfolio in the year ahead.
Importantly, we expect our robust commercial performance to meaningfully contribute to our strong financial position.
And our ability to drive growth across the business and.
And as Mark said, our current cash position provides runway to fund our operations, including a new indication for IV poop out into at least 2027.
Ultimately, we're determined to continue to provide life changing medicines to patients.
Building sustainable value.
And we believe we are strategically positioned to do that.
Want to thank all VP of time today, and I'll hand, it back to the operator for any questions.
Thank you as a reminder, if you would like to ask a question at this time. Please press star one.
And then wait for your name to be announced to withdraw your question. Please press star one again, one moment, while we compile our Q&A roster.
Operator: One moment while we compile our Q&A roster, and our first question is going to come from the line of Unirom. Anupam Rama with JPM.
And our first question comes from the line of <unk>.
Your next <unk> Rama with J P. M. Your line is open. Please go ahead.
Anupam Rama: Your line is open. Please go ahead. Hey guys, this is Anupam.
Hey, guys. This is unit palm.
Anupam Rama: Thanks so much for taking the question. We talked a lot about repeat prescribers in the opening comments. What are the keys to getting new prescribers at this point, given now we're entering kind of like the third year of launch, or is this slowly transitioning to more of a repeat prescriber model to drive growth? Thanks so much. Hi Anupam, this is Ross.
Thanks, so much for taking the question.
And we talked a lot about repeat prescribers.
In the opening comments what are the keys to getting new prescribers at this point given now we're entering kind of like the third year of launch or is this slowly transitioning to more of a repeat prescribers to drive growth. Thanks. So much.
Hi, Adam Hi, This is Ross thanks, very much for the question, Yes, we continue to see good goodbye and both new prescribers and repeat prescribers as of the end of 2020 to it and we've got lots of headroom ahead of us as well just to look back a little bit we ended 2022 with around 800 over.
Ross Mote: Thanks very much for the question. Yeah, and we continue to see good growth in both new prescribers and repeat prescribers as of the end of 2022, and we've got a lot of headroom ahead of us as well. Just to look back a little bit, we ended 2022 with around 800 or more than 800 prescribers, and about 22% of those were repeat prescribers. By the end of 2023, we had more than 1700 prescribers. So, obviously, more than doubling year on year, and 24% of those were repeat prescribers. So, as outlined in the prepared remarks, we've seen good, steady growth in the repeat prescriber base, but to your question about new prescribers, again, we think we've still got a long way to go with the expansion of our field force. We entered this year with around 85 representatives.
800, prescribers and about 22% of those who have repeat prescribers at the end of 2023, we had more than 1700 prescriber, so obviously more than doubling.
Throughout the year on year, and 24% of those as repeat prescribers as outlined in the prepared remarks, we've seen good steady growth in the repeat prescriber base.
Your question for New Prescribers again, we think we still got a long way to go with the expansion of our field force that we entered this year with about 85.
Ross Mote: We're now covering through to around 11,000 doctors, so that's a significant increase from what we were targeting previously with our slightly smaller field team. So, you can even just see from that, from 11,000 targeted doctors, we've got more than 1700 total prescribers as of the end of last year, and certainly not all of those 1700 are within the target pool as well. So, I think from that, that really shows you that there's still a huge amount of opportunity out there for us, which is also, I guess, backed up in the penetration into the target opportunity for the patients that we have on our list, around 9% as well. So, I'm pretty excited about the opportunity we've got ahead on both the new and
Representatives.
We're now covering through to around 11000 doctors, so thats a significant increase from.
What we were targeting previously with a slightly smaller field team.
So you can even just see from that from 11000 targeted adopters, we've got more than 1700 total prescribers as at the end of last year and certainly not all of those 1700 or within the targets Paul as well. So I think from that that really shows you that there's still a huge amount of opportunity out there for us which of those.
Say, I guess backdrop and the penetration into the <unk> opportunity for the patients that we have on <unk>.
Around 9% as well so.
Really excited about the opportunity we've got ahead on price that new and repeat prescribers enzyme.
Ross Mote: Thanks so much for taking our questions. Thank you, and one moment as we move on to our next question. And our next question is going to come from the line of Paul Troy with Goldman Sachs. Your line is open. Please go ahead. Hi, good morning, everyone, and congratulations on the strong finish to 2023. My first question is just about how you're thinking about additional investment here for the commercial business.
Thanks, so much for taking our question.
Okay.
Thank you and one moment as we move on to our next question.
Yeah.
And our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.
Hi, good morning, everyone and congrats on the strong finish to 2023. My first question is just on.
How youre thinking about additional investment here for the commercial business.
Ross Mote: I know, obviously, Ross just mentioned the recently expanded Salesforce, but maybe just some thoughts on promotional efforts to increase brand awareness, some DTC, and or, you know, increasing medical meeting, conference, education, and things like that. And just, you know, kind of how you're thinking about the rate of investment for the business beyond the recent Salesforce expansion. And then I had a follow-up question on, Thanks, Paul. This is Ross as well, so maybe I'll take the first pass at that at least.
Obviously, Ross mentioned recently expanded salesforce, but maybe just some thoughts on it.
Promotional efforts to increase brand awareness, some DTC <unk>, increasing medical meeting.
Conference.
Education, and things like that and just kind of how youre thinking about the rate of investment for the business beyond the recent sales force expansion and then I had a follow up question.
We put part.
Thanks, Paul This is Ross as well, so maybe I'll take the first part of that.
Ross Mote: So I think all those things that you mentioned continue to be important to us, as they have done all the right things through from launch, even with, you know, a larger field team out there now. Congress supports digital marketing, peer-to-peer education, speaker programs, speaker bureau, all those types of initiatives continue to be very important. And that's because we know patients are quite widely dispersed across the U.S., as you can see from all the numbers that we share. So those opportunities remain, and it remains important for us to do so. But we have increased the field team and feel pretty good about that and the number of physicians that we can cover. So I think, you know, we've been very thoughtful and data-driven in the build to that field team increase. And we will continue with other digital marketing and other types of initiatives as we always have done.
So I think all of those things that you mentioned continue to be important to us as they have done the right way threes from launch.
With a larger field team out that now Congress supports digital marketing peer to peer education Speaker programs Speaker Bureau, those types of initiatives continue to be very important and that's because we know patients are quite widely disbursed across the U S. As you see from all the the numbers that we share.
So those opportunities remain and it remains important for us to do that but.
But we have increased the field team and feel pretty pretty good about bots and the number of physicians that we can that we can cover.
So I think we've been very thoughtful very data driven and the billboards to fill team increase.
And we continue along the other digital marketing and other types of initiatives as we always have done.
Ross Mote: Okay, great. Thanks, Ross. And then for a follow-up question from Avi Rupart, since you've picked a new indication, which has yet to be specified, can you maybe just comment on how the data from Cohort 4 might affect your developmental strategy and the Phase 2b strategy beyond dosing frequency, just anything else that you're looking for in terms of insight there from Cohort 4? Thanks for taking our question. Thanks, Paul. This is Sanj. Maybe I'll start and then John can jump in.
Okay, great. Thanks, Ralph and then for a follow up for <unk>.
You've picked a new indication, which has yet to be specified can you maybe just.
Comment on how the data from cohort four.
Your developmental strategy and in the phase <unk> strategy.
Beyond beyond dosing frequency, just anything else that youre looking for in terms in terms of insight there from cohort four thanks for taking our questions.
Thanks, Paul This is Tom maybe I'll start and then John can jump in I mean, I think as you said we were very encouraged by the data we had from cohorts one two and three which really largely has given us sort of the go signal to move forward with that program.
Sanj K. Patel: I mean, I think, as you said, we were very encouraged by the data we had from courts one, two, and three, which really largely has given us sort of a goal signal to move forward with that program and an additional indication. So the data we already have has given us a target. I think cohort four will help us, as I said earlier, with the dosing design of the trial. But maybe, John, you could elaborate a little bit on that.
And then additional indications so the data we already have is given the go I think cohort four whole pleasant as I said earlier with the dosing design of the trial, but maybe John you could elaborate a little bit on that.
Sanj K. Patel: So it's really more of a sort of design implementation as opposed to whether we go or not. Right? Thank you, Sanj. And Paul, nice to talk to you. So the way that Cohort 4 is designed is it's designed to generate plasma concentrations that sit in between two clinically active doses, the two milligrams per kilo biweekly and the five milligrams per kilo biweekly. So, in that sense, it moves down the bar, if you will, to see if there's still activity at that concentration, which is still roughly an order of magnitude above what is required for full receptor occupancy and TDR suppression.
So it's really more of a sort of design.
Implementation as opposed to whether we go now.
Thank you, Jeff and Paul Nice to talk to you.
So the way that cohort four is designed is it's designed to generate plasma concentrations that sit in between two clinically active doses. The two milligram per kilo biweekly and the five milligram per kilo biweekly so in that sense it moves down.
Bar, if you will to see if there is still activity at that concentration, which is still roughly in order of magnitude above what is required for full receptor occupancy and SEDAR suppression and so in that sense. It will round out the PK PD modeling. So then then we can choose dosing regiments that we can carry forward into subsequent.
John F. Paolini: And so, in that sense, it will round out the PK PD modeling so that then we can choose dosing regimens that we can carry forward into subsequent development and give us a full range of options to choose from. Thank you. And again, ladies and gentlemen, if you would like to ask a question at this time, please press star 11 on your telephone. And I'm showing no further questions at this time, and I'd like to hand the conference back over to Sanj Patel, Chief Executive Officer, for any further remarks. Thanks, Operator. Thanks for all the questions and, obviously, the time to join the call today. We clearly have an exciting year ahead of us, and we're very much looking forward to providing additional updates in the future. So, with that, thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!
Development gives us a full range of options to choose.
Okay.
Thank you and again, ladies and gentlemen, if you would like to ask a question at this time. Please press star one on your telephone.
Yes.
And Im showing no further questions at this time I would like to hand, the conference back over to Sanjay Patel, Chief Executive Officer for any further remarks.
Thanks, operator, so thanks for all the questions and obviously the time to join the call today, we clearly have an exciting year ahead of us and we're very much looking forward to providing additional updates in the future. So with that thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.
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