Q1 2024 Calliditas Therapeutics AB (publ) Earnings Call
<unk> of the company and him to do it today joined by Frederic Johansen, Our Chief Financial Officer, Richard Philippson, Our Chief Medical Officer, and Maria <unk>, Our President of North America.
Next page please.
Speaker Change: I'd like to draw your attention to the disclaimer notice which covers forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095, as amended and I refer to public filings.
Putting those containing risk factors next page please.
Speaker Change: Yeah.
Speaker Change: So I'd like to take you through some of our Q1 highlights which included the appointment of myriad torn fan as president in North America.
Speaker Change: He brings over 10 years of rare disease experience or kalitta tests, including multiple product launches both in the U S and ex U S.
Following a full approval in December last year, we were able to roll out new marketing materials to a fully trained field team in February introducing the new indication of reduction of loss of kidney function to nephrologists in the U S.
Speaker Change: In February we also announced that the U S. PTO had issued a new patent covering our payout with exploration in 2043.
Speaker Change: In March we could also announced that the FDA had granted her seven years of orphan exclusivity for the new indication, which expires in December of 2030.
Speaker Change: Finally, we also saw the approval in Singapore or in Africa, which will be known as Nerf again next page. Please.
In terms of commercial highlights for the quarter.
Speaker Change: This I want to from a commercial perspective this quarter was another record quarter in terms of enrollments with 705, new enrollments, reflecting a 27% increase over the previous quarter, and which we saw a 51% increase.
Speaker Change: This continued strong demand is very encouraging and we continue to see strong demand for the product in the market.
Speaker Change: As expected we saw somewhat of a lighter quarter from a revenue perspective due to the typical re verification process, but this quarter also saw something quite unexpected in the form of a cyber attack on change health one of the three providers of claims processing in the U S.
Speaker Change: We use one specialty pharmacy management, biologics, which exclusively use change health.
Speaker Change: Which due to the delays in processing.
Speaker Change: Due to the cyber attack led to a negative impact on the quarter of approximately $4 $7 million, resulting in net product revenues for the quarter of $26 8 million.
Speaker Change: We do not expect this to have any impact on our annual revenues that these revenues are not lost but merely pushed out in time.
Speaker Change: We did also borne out by the strong start to Q2 reflected by net product revenues quarter to date of approximately $25 $5 million with an additional five weeks to go in the quarter.
Speaker Change: The team is during the quarter undertaking a very substantial number of PMT committee meetings, and we're starting to see some plans update their rules, but our expectations remain that the majority of plans will update their rules in the June July timeframe.
Speaker Change: We're also hopeful that EMA will review and make recommendations regarding a potential full approval of <unk> at their next meeting.
Speaker Change: And in the period post the quarter. We also were excited to see the commercial launch in China by our partner Everest medicines.
Speaker Change: H B.
Speaker Change: Yeah.
Speaker Change: Other post period events. So we did have a positive readout of our phase II proof of concept trial in head and neck cancer.
Speaker Change: Which Richard will give you a little bit more information on what we saw statistically significant benefits in progression free survival as well as overall survival.
Richard: There's also an R&D day, that's been scheduled for may 30th to provide some additional information around certain exit.
Richard: Yeah.
Richard: We also have supportive open label extension data, which was presented at era EDTA. There were several abstracts presented at the <unk> World Congress of Nephrology, which again Richard will cover shortly.
Speaker Change: There was also new patent in the form of a notice of allowance that was received for such an active in the area of cancer.
Everest medicines: And as I already mentioned there was the commercial launch in China by Everest medicines.
Next page please.
Speaker Change: So in conclusion to this section I just want to highlight that we are very excited about what 2024 will bring following a successful start in Q1.
That includes the potential full approval or can pay go in Europe, the commercial build out in China with the potential.
Four in Africa to be included in negotiations related to national reimbursement already this year potentially.
Speaker Change: The readout of <unk> data from the phase II trial in PBC, which we expect to be able to share with you in Q3.
Speaker Change: The readout from our phase two investigator led study in IPF, which we're hoping to be able to share with you in Q4.
Speaker Change: Reimbursement decisions expected for additional countries in Europe by our partner working with that startup.
Speaker Change: And then we're also hopeful that we will see the start with phase III study in Japan with <unk> by our partner by actress and obviously, we're certainly looking forward to continued strong growth of <unk> in the U S market.
Speaker Change: And with that I'm going to hand over to Richard Philippson. Okay. Thank you very much money.
Richard Philippson: The next slides I'd like to start by talking briefly about our recent conference attendance.
We're delighted to have had a strong presence at the World Congress of Nephrology a call.
Richard Philippson: Organized by the International Society of Nephrology, which was held in Buenos Aires.
The 16th April this year.
Speaker Change: For posters and also how will the sponsored symposium.
Speaker Change: Richard Lafayette, Laura Mariani, and Heather Reef presented and discussed the evolving landscape of Egfr and proteinuria surrogate markers in Iga nephropathy.
Speaker Change: We very much value the opportunity to meet with Nephrologists from the U S. And also for many other countries, where we were able to talk or Iga nephropathy and hear about their experiences in managing the condition.
I'd like to highlight some of the data and analyses that we presented.
Speaker Change: This conference call.
Speaker Change: One of the important observations that we've made in the secondary analysis of the phase III <unk> trial was at the time to 30% reduction in Egfr or kidney failure was significantly delayed in patients treated with Mexico.
Speaker Change: This analysis was presented in a poster WCS and is also illustrated in the figure on the rights of this slide demonstrates in a 55% reduction in the risk of an event in patients treated with ethicon.
Speaker Change: <unk> placebo treated patients, which was statistically significant with a P value of 0.001 pool.
Speaker Change: It's also noteworthy that this treatment effect was consistent irrespective of baseline UPC all category.
Speaker Change: Is that ratio is 1.5142 for the <unk>.
Speaker Change: Below and above one five gram per Gram UPC categories.
Speaker Change: Other posters presented additional additional analyses from the difficult comp. These posters included a subgroup analysis, indicating that <unk> was efficacious and well tolerated irrespective of white or Asian race.
Speaker Change: Our poster described the beneficial effects of an ethical in egfr slope in patients with lower levels of baseline proteinuria.
Speaker Change: And finally, a poster describing quality of life outcomes.
Speaker Change: Next slide.
Speaker Change: So I'd now like to move on and talk about the recently announced results of the Companys phase II proof of concept study in squamous cell carcinoma of the head and neck and.
Speaker Change: Excellent.
As a brief reminder, this was a randomized placebo controlled double blind phase II study investigating the effects of <unk> 800 milligrams twice daily in conjunction with <unk> 200 milligrams IV administered every three weeks.
Speaker Change: Patients with recurrent or metastatic squamous cell carcinoma of the head and neck and with moderate or high levels of cancer associated fibroblast in the tumor will randomized to receive <unk> or placebo on top of standard of care <unk>.
Speaker Change: The tumor biopsy was taken prior to randomization and again approximately nine weeks after the staff treatment.
Speaker Change: Treatment continued until disease progression.
Speaker Change: For brevity I'll subsequently described the treatment groups assessing Mexico placebo, but please remember that these randomized treatments given an addition to embellish on that one.
Speaker Change: Thanks.
Speaker Change: The study was conducted in 37 sites in seven countries. The last patient was randomized on the 20 <unk> of October 2023 data collected until all randomized patients.
Speaker Change: <unk> 15 weeks of follow up.
Speaker Change: The primary analysis comprised 55 randomized patients and included 38 progression events, which was in line with our target for the statistical analysis.
Speaker Change: The treatment groups were well balanced at baseline and importantly, no patients were excluded from any of the analysis says nor whether any important protocol deviations that we'll consider it likely to impact efficacy.
Speaker Change: Next slide.
Speaker Change: Yeah.
Speaker Change: We observed statistically significant improvements in progression free survival and overall survival.
Speaker Change: Median progression free survival was five months in sysmex of treated patients versus two nine months in placebo treated patients. The hazard ratio for this outcome was <unk> five eight in other words patients treated with <unk> had a 42% lower risk of experiencing disease progression at any time during the study.
Speaker Change: Six months, 92% assessment.
Speaker Change: Patients were alive compared to 68% placebo treated patients.
Speaker Change: The respective percentages were 88% and 58% to nine months and the hazard ratio for this outcome was <unk> 45 and <unk>.
Speaker Change: Other words patients treated with <unk> had.
Speaker Change: 55% lower risk of death at any time during the study.
Speaker Change: We also saw a higher percentage assessment exit treated patients achieving a best response of at least stable disease.
Speaker Change: 70% of <unk> treated patients showed the best response at least stable disease compared to 52% of placebo treated patients and their responses in <unk> patients appear to be more favorable.
Speaker Change: It was very pleasing to see a corresponding increase in CDA positive T cells in tumor tissue in response to <unk> treatment, which supports the mechanism of action assist <unk> in solid tumors and indicates an increase in the immunological activity that the tumor.
It has a 42% lower risk of experiencing disease progression at any time during the study.
Speaker Change: Is there a significant difference in the primary endpoint of best percentage change from baseline in tumor size from a safety point of view the tolerability of <unk> when given with <unk> was generally good with no new safety signals items.
Six months, 92% of <unk> treated patients were alive compared to 68% of placebo treated patients.
Speaker Change: Next slide.
The respective percentages were 88% and 58% to nine months.
Speaker Change: So in summary, we saw statistically significant improvements in progression free survival and overall survival with more durable responses and <unk> treated patients.
Hazard ratio for this outcome was four five.
Other words patients treated with <unk> had a 55% lower risk of death at any time during the study.
Speaker Change: An increase in intra tumoral CDA positive T cells in Cessna ex of treated patients, which is in line with the mechanism of action assessing exit and integrate indicates an increase in the immunological activity of the tumor finally, <unk> was generally well tolerated when given with pepper lithium out there were no new safety signals.
We also saw a higher percentage of <unk> treated patients achieving a best response of at least stable disease.
70% of <unk> treated patients showed the best response at least stable disease compared to 52%.
<unk> treated patients and their responses in <unk> patients are paid to be more favorable.
Speaker Change: <unk>.
Speaker Change: So I'd like to now hand over to <unk>.
It was very pleasing to see a corresponding increase in CDA positive T cells and Cima tissue in response to <unk> treatment, which supports the mechanism of action of Cessna exhibit in solid tumors and indicates an increase in the immunological activity the tumor.
Speaker Change: Thank you very much Richard.
Speaker Change: Slide.
Speaker Change: Okay.
Speaker Change: As you recall in Q4 2023, we had our strongest quarter since launch with 555 enrollment forms.
Speaker Change: And in the first quarter of 'twenty 'twenty four we continue to see very strong demand for <unk> is 705 enrollment forms received by our patient services hub to our payer touch points.
Speaker Change: Was there a significant difference in the primary endpoint of best percentage change from baseline in tumor size.
Speaker Change: I'm a safety point of view the Tolerability assessments.
Speaker Change: When given with <unk> was generally good.
Speaker Change: During this quarter. We also have 354, new prescribers, which is another record since launch we now have close to 2000 health care providers, who have prescribed our payout.
Speaker Change: No new safety signals items.
Speaker Change: Next slide.
Speaker Change: So in summary, we saw statistically significant improvements in progression free survival and overall survival with more durable responses and <unk> treated patients.
We believe that the strong demand. We're seeing is an early sign of the impact of a full approval, our new label with the removal of the UPC, our criteria and physicians recognizing the impact to pay you have on reducing the loss of kidney function.
Speaker Change: As an increase in intra tumoral CDA positive T cells in <unk> treated patients.
Speaker Change: Which is in line with the mechanism of action assessing exit and integrate indicates an increase in the immunological activity of the tumor finally, <unk> was generally well tolerated when Kevin with Tempur lithium out there were no new safety signals.
Our total sales so choppy in Q1 was $26 8 million.
Speaker Change: As Rene mentioned earlier Q1 was impacted by seasonal changes due to the open enrollment period in the U S as well as the cyber attack unchanged hub.
Speaker Change: So I'd like to now hand over to Maria <unk>.
Maria: Thank you very much.
Speaker Change: Next slide.
Speaker Change: It does not impact our 2020 for guidance.
Speaker Change: As you recall in Q4 2023, we had our strongest quarter since launch with 555 enrollment forms.
Speaker Change: As you can see from our estimated 2% to sales to date, we have seen a very strong revenue in the first eight weeks of the quarter with approximately $25 $5 million of net sales.
Speaker Change: And in the first quarter of 2024, we continue to see very strong demand.
Speaker Change: It's 705 enrollment forms received by our patient services hub, our payout touch points.
Speaker Change: Next slide please.
Speaker Change: Yeah.
Speaker Change: In the first quarter, we launched a full approval of <unk> with multiple commercial and medical activities.
Speaker Change: During this quarter. We also have 354, new prescribers, which is another record since launch we now have close to 2000 health care providers, who have prescribed our payout.
Speaker Change: As a reminder for payers the first and only product approved by the FDA to reduce the loss of kidney function for patients at risk of progression.
Speaker Change: We believe that the strong demand. We're seeing is an early sign of the impact of a full approval a new label with the removal of the ECR criteria and physicians recognizing the impact on reducing the loss of kidney function.
Speaker Change: Our field teams are trained on a new label and are promoting it to health care professionals.
Speaker Change: We have also launched various new patient educational programs and materials.
Speaker Change: And for market research, we know that patients appreciates tour pay us nine months treatment course with no rems requirement.
Speaker Change: Our total sales such our pay in Q1 was $26 8 million.
Speaker Change: Provides them with the freedom to complete the course and see the long term benefit.
Speaker Change: As Rene mentioned earlier Q1 was impacted by seasonal changes due to the open enrollment period in the U S.
Speaker Change: Our medical team have been engaged in multiple scientific exchanges and participated congresses.
Speaker Change: As the cyber attack unchanged.
WGN presenter: At WGN in April we have presentations, highlighting the egfr results and impact of course of loss experienced by patients in the clinical trial.
And this does not impact our 2020 for guidance.
Speaker Change: As you can see from our estimated two to sales to date, we've seen a very strong revenue in the first eight weeks of the quarter with approximately $25 $5 million of net sales.
Speaker Change: And finally, our market access team has been busy engaging with payers educating them on the new label the inclusion of the Egfr data and removal of the UPC our criteria.
Speaker Change: Next slide please.
Speaker Change: In the first quarter, we launched a full approval of <unk> with multiple commercial and medical activities.
Speaker Change: Next slide please.
Speaker Change: We're very excited about the opportunity ahead of us.
Speaker Change: As a reminder for payers the first and only product approved by the FDA to reduce the loss of kidney function for patients at risk of progression.
Speaker Change: It would be a very strong demand for <unk>, both from existing and new prescribers, who recognized for payors positioning as a disease modifying therapy in Idaho.
Speaker Change: Our field teams are trained on a new label and are promoting it to health care professionals.
Speaker Change: Our focus is on continuing our promotional efforts with our expanded field team and drive scientific exchange at large comprehensive.
Speaker Change: We have also launched various new patient educational programs and materials.
Speaker Change: And for market research, we know that patients appreciates or pay us nine months treatment course is no rems requirement.
Speaker Change: We're eagerly awaiting the update of the <unk> guidelines.
Speaker Change: Estimate there will be published in the second half of 2024.
Speaker Change: It provides them with the freedom to complete the course and see the long term benefit.
These guidelines have the potential to broaden the definition of the at risk population and also support the use of <unk> as the only fully approved drug with impact of Egfr.
Speaker Change: Our medical team have been engaged in multiple scientific exchanges and participated a congresses.
Speaker Change: At WGN in April we have presentations, highlighting the egfr results and impact of quality of life experienced by patients in the clinical trial.
Speaker Change: As mentioned earlier, we're continuing to focus on engaging with U S payers to ensure that their policy to reflect the new label.
Speaker Change: And finally, our market access team have been busy engaging with payers educating them on a new label inclusion of the Egfr data and removal of the UPC our criteria.
Speaker Change: We've already seen one of the largest payers in the U S Unitedhealthcare ups.
Speaker Change: State their policy in May.
Speaker Change: We are anticipating that the largest payers will update their policies mid 2024.
Speaker Change: Next slide please.
Speaker Change: This should facilitate access for patients a reduced market access barriers.
They're very excited at the opportunity ahead of us.
Fredrik: And with that I will hand, it over to our CFO fredrik to have something to talk about our financials. Patrick. Thank you Maria next slide please.
Speaker Change: It would be a very strong demand for crop hail book.
Speaker Change: From existing and new prescribers, who recognize our payors positioning as a disease modifying therapy in <unk>.
CFO Fredrik: I will now present to you the financial overview for the first quarter.
Speaker Change: Our focus is continuing our promotional effort with our expanded field team and drive scientific exchange at large comprehensive.
CFO Fredrik: Yes.
Speaker Change: The numbers presented to you our immune sick unless otherwise stated.
Historically, we reported through nine months volume put $5 million in net revenues for the quarter for the same quarter last year, we reported net revenues of 191 for $3 billion.
Speaker Change: We're eagerly awaiting the update of the <unk> guidelines.
Speaker Change: Estimates it will be published in the second half of 2024.
Speaker Change: So apparel net product sales for the quarter amounted to $273 million work for $6 8 billion.
Speaker Change: These guidelines have the potential to broaden the definition of the at risk population and also support the use of <unk> as the only fully approved drugs with impact of Egfr.
Speaker Change: Which is a reported increase of 50% from the same quarter previous year.
Speaker Change: As Ray mentioned this Winfield cyber attacks had an estimated negative impact from our revenues in the quarter of approximately four 7 million were approximately $50 million.
Speaker Change: As mentioned earlier, we're continuing to focus on engaging with U S payers to ensure that their policy to reflect the new label.
Speaker Change: This revenue is not lost but we will roll forward into the next several months. Therefore, we're after the you today on our progress.
Speaker Change: We've already seen one of the largest payers in the U S unitedhealthcare.
Speaker Change: State their policy in May and we are anticipating that the largest payers will update their policies mid 2024.
Speaker Change: To date for the payout in the second quarter and we were very encouraged to report that the preliminary net sales in the second quarter to date amongst one to five 5 million.
Speaker Change: This should facilitate access for patients a reduced market access barriers.
And with that I will hand, it over to our CFO fredrik to have something to talk about our financials.
Speaker Change: Each are almost already at the level. The report Q1, Threep unit sales with approximately 40% of the remaining.
Speaker Change: Thank you Maria next slide please.
Speaker Change: The remaining $30 million in revenues in the quarter is related to our partnerships primarily from royalties for Europe from startup.
Fredrik: I will now present to you the financial overview for the first quarter.
Speaker Change: Yeah.
Speaker Change: The numbers presented to you our immune sick unless otherwise stated.
Speaker Change: For the same quarter last year, we had royalty revenues for Europe, four 4 million.
Fredrik: Historically, we reported $299.5 million and net revenues for the quarter.
Speaker Change: Our total operating expenses for the quarter amounted to $485 3 million compared to $362 million for the same quarter last year.
Fredrik: For the same quarter last year, we reported net revenues of 191 for $3 million.
Fredrik: So our premium net product sales for the quarter amounted to $273 million work for $6 8 billion, which.
Speaker Change: The cost for research and development increased by $24 million in the quarter to 156.
Fredrik: Which is a reported increase of 50% from the same quarter previous year.
Speaker Change: $6 million compared to $126 7 million for the same quarter previous year.
Speaker Change: As Ryan mentioned potential cyber attacks had an estimated negative impact from our revenues in the quarter for approximately $4 $7 million were approximately $50 million.
Speaker Change: And this is primarily related to a pipeline will reduce the cost to bring it up and had a Nick and I have two more expected data readouts this year, including the reader can be PVC, which.
Speaker Change: This revenue is not lost but we will roll forward into the next several months.
Speaker Change: Which is expected in the third quarter.
Speaker Change: Therefore, we are up to the year to date on our progress to date.
Speaker Change: Moreover, because we had four trials rami, including the open label extension extension in the head and neck, which are close to be completed also from a cost perspective.
Speaker Change: In the second quarter, and we were very encouraged to report that the preliminary program net sales in the second quarter to date amongst $225 million.
Speaker Change: The <unk> trial, which are running which will speed the R&D costs between the quarters may be somewhat lumpy and less linear this year.
Speaker Change: Which are almost already at the level at the report Q1 net sales with approximately 40%.
Speaker Change: But as previously communicated we expect R&D cost for the year to be broadly in line with the previous year.
Speaker Change: Remaining.
Speaker Change: The remaining Codamine and revenues in the quarter is related to our partnerships primarily from royalties for Europe from startup.
Speaker Change: The cost for sales and marketing increased by $72 nine new luminary quarter to $240 1 million compared to 160 to $7 2 million for the same quarter previous year.
Speaker Change: For the same quarter last year, we have royalty revenues for Europe, four 4 million.
Speaker Change: Our total operating expenses for the quarter amounted to $485 3 million compared to $362 million for the same quarter last year.
The increase is primarily related to sales and marketing of to bring in the U S where were during the quarter continue to work to leverage the market opportunity particular payer food approval. We received at the end of last year.
Speaker Change: The cost for research and development increased by $24 million in the quarter to 150.
Speaker Change #100: These included costs related to complete the new marketing materials due to the new indication.
Speaker Change: 6 million compared to $126 7 million for the same quarter previous year.
Speaker Change #101: And as previously communicated we started these investments in the commercial organization already in Q4, and we have particular strength in the sales marketing and market access functions during the first quarter.
Speaker Change: And this is primarily related to a pipeline, where we just had the cost to bring it out in head and neck.
Speaker Change: Two more expected data readouts this year, including the reader can be PVC, which.
We made an operating loss in the quarter of $203 8 million compared to a loss of $108 1 million for the same quarter last year.
Speaker Change: Which is expected in the third quarter.
Speaker Change: Moreover, as we have four trials rami, including the open label extension extension in the head and neck, which are close to be completed also from a cost perspective.
Speaker Change #102: Cash flow used in operating activities in the quarter was $198 2 million compared to June $31 9 million from same quarter previous year and this leaves us with a net decrease in cash in the first quarter up from the seven 5 million and we continue to have a healthy cash position of $810 3 million at the end of the quarter.
Speaker Change: The <unk> trial, which are running which will speed the R&D costs between the quarters may be somewhat lumpy and less linear this year.
Speaker Change: But as previously communicated we expect R&D cost for the year to be broadly in line with the previous year.
Speaker Change #103: At last I wanted to bring to your attention that lever or 24 total difficult perennial net sales estimate unchanged of between $150 million to $180 million for the year.
Speaker Change: The cost for sales and marketing increased by $72 $9 million quarter to June of $40 1 million compared to $167 2 million for the same quarter previous year.
Speaker Change: The increase is primarily related to sales and marketing up to bring in the U S where we're doing the quarter continue to work to leverage the market opportunity put it or pay a full approval. We received at the end of last year.
Speaker Change #104: Therefore, all for me, Thank you and now back to you with.
Speaker Change #105: Thank you very much next page please there to go.
Speaker Change #106: So just some key takeaways for the quarter as you've heard this was another record quarter. Both in terms of enrollments and new prescribers with 705, new enrollments and 354, new unique prescribers.
Speaker Change: These included costs related to complete the new marketing materials due to the new indication.
And as previously communicated we started these investments in the commercial organization already in Q4, and we are particularly strength in the sales marketing and market access functions during the first quarter.
We have seen an improved product protection of <unk> on the form of both orphan exclusivity as well as patent protection.
Speaker Change: We made an operating loss in the quarter of $203 8 million compared to a loss of $108 1 million for the same quarter last year.
Speaker Change #107: With the new patents expiring in 2043 have ranked our payout and orphan exclusivity in the U S for the new indication expiring December 2030.
Speaker Change: Cash flow used in operating activities in the quarter was $198 2 million compared to June of $31 9 million from same quarter previous year and this leaves us with a net decrease in cash in the first quarter of $275 million and we continue to have a healthy cash position of $810 3 million at the end of the quarter.
Speaker Change #107: As Maria has shown there continues to be strong demand for <unk>.
Speaker Change #108: With this disease modifying mechanism.
Maria: And we believe that the recent <unk> data clearly supports its anti fibrotic effect.
Maria: And we are looking forward to and excited about the upcoming readouts in our clinical pipeline related to our rare diseases.
Speaker Change: At last I wanted to bring to your attention that believe or 24 total difficult perennial net sales estimate unchanged at between $150 million to $180 million per year.
Speaker Change #110: And finally, our total revenue guidance remain unchanged, reflecting strong growth expectations.
Rich: That was all for me, Thank you and now back to rich.
Speaker Change #111: $150 million to $180 million for the year for the entire <unk> franchise.
Rich: Thank you very much.
David: Please David.
Speaker Change #112: And with that we're happy to take your questions.
Speaker Change: So just some key takeaways for the quarter as you've heard this was another record quarter, both in terms of enrollments and new prescribers.
Speaker Change: 705, new enrollments and 354, new unique prescribers.
Speaker Change #113: If you wish to ask a question. Please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question. Please dial pound key.
Speaker Change: We have seen an improved product protection of <unk> on the form of both orphan exclusivity as well as patent protection.
Speaker Change: With the new patents expiring in 2043 have been to our payout and orphan exclusivity in the U S for the new indication expiring December 2030.
Speaker Change #113: <unk> on your telephone keypad.
Speaker Change #113: The next question comes from Maury Raycroft from Jefferies.
Speaker Change: As Maria has shown there continues to be strong demand for <unk>.
Maury Raycroft: Please go ahead.
Joe: Good morning. This is Joe on the call for Maury.
Speaker Change: With this disease modifying mechanism.
Speaker Change: And we believe that the recent set the Max data clearly supports its anti fibrotic effect.
Joe Maury: Can you maybe talk about how many new patients star forms you have seen so far in the second quarter.
And we are looking forward to and excited about the upcoming Readouts.
Speaker Change #117: 4% to 25 five.
Speaker Change: Our clinical pipeline related to our rare diseases.
Speaker Change #118: <unk> revenue in the second quarter, which day, where the cutoff date and was the $4 7 million.
Speaker Change: And finally, our total revenue guidance remain unchanged, reflecting strong growth expectations.
Speaker Change #119: Included in it and what are some of the additional assumptions and drivers behind the reiterating revenue guidance for 2024.
Speaker Change: $150 million to $180 million for the year.
Speaker Change: For the entire <unk> franchise.
Speaker Change #120: I'll have a follow up question.
Speaker Change: And with that we're happy to take your questions.
Speaker Change #121: Alright, well those are four questions, let me see if I can.
Speaker Change #121: And start with that.
Speaker Change #121: So in terms of the actual.
Speaker Change #122: Of the $4 7 million, let's start there obviously they will be.
Speaker Change #123: Kind of if somebody that will catch up over the next several months so its not something that necessarily only going to be in Q2, it'll probably be go both over Q2 and Q3 as the quarter Hasnt and then we're not really in a position to be any more precise about where we might have seen what coming in from Canada.
Speaker Change: If you wish to ask a question. Please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question. Please dial pound key.
Speaker Change: <unk> on your telephone keypad.
Speaker Change: The next question comes from Maury Raycroft from Jefferies.
Speaker Change #124: The hybrid <unk>.
Speaker Change #125: So I think that's going to have to wait until the quarter is actually completed.
Speaker Change: Please go ahead.
Yao: Good morning. This is yao on the call for Maury.
Speaker Change #126: In terms of the we're not going to report on any other aspects of Q2.
Yao: Can you maybe talk about how many new patients are formed you have seen so far in the second quarter.
Speaker Change #127: We felt that this was a kind of a bit of an exception because obviously the cyber attack or something that was outside of our control.
Speaker Change: 4% to $25 five.
Speaker Change #127: And it was kind of like the technical issues. We wanted to provide some insight into kind of the quarter to date and that is truly quarter to date. So that is as of the reporting date.
<unk> revenue in the second quarter, which day, where the cutoff date and was the $4 7 million.
Speaker Change: Included in that and what are some of the additional assumptions and drivers behind the reiterating revenue guidance for 2024.
Speaker Change #128: And so that's I think that covered all of the questions.
Speaker Change #128: Okay.
Speaker Change #128: Yeah.
Speaker Change #129: Yeah. Thanks, so much for that.
Speaker Change: And I'll have a follow up question.
Speaker Change #129: Then I guess the second question is.
Speaker Change: Alright, well that's it for questions.
Speaker Change: I can start with that.
Speaker Change #130: Could you maybe provide some additional color on the phase III open label extension data for <unk>, how does the data inform the treatment gap in timing for starting a second course of therapy.
Speaker Change: So in terms of the actual.
Speaker Change: Kind of the $4 7 million, let's start there, it's obviously they will be kind.
Speaker Change: Kind of if somebody will catch up over the next several months so its not something that necessarily only going to be in Q2, it'll probably be go both over Q2 and Q3 as the quarter Hasnt and then we're not really in a position to be any more precise about where we might have seen work coming in from Canada.
Speaker Change #131: Also our the data consistent with what Youre seeing in a real world. Thank.
Thank you so much I'll hop back in the queue.
So the data will be presented at the upcoming era EDTA.
Speaker Change #132: And I think that as we mentioned in the press release.
Speaker Change: The hybrid.
Speaker Change #133: What we've seen is kind of consistent trends and patterns that we saw in the original phase III trial.
Speaker Change: I think that's going to have to wait until the quarter is actually completed.
Speaker Change: In terms of the we're not going to report on any other aspects of Q2 I think we felt that this was a kind of a bit of an exception because obviously the cyber attack or something that was outside of our control.
Speaker Change #134: So I think that we'll be happy to kind of take more questions or discuss is maybe more at the R&D day when the when we when we cover some of those aspects as well and where we will be joined by Professor Barnes.
Speaker Change: And it was kind of like the technical issues. We wanted to provide some insight into kind of the quarter to date and that is truly quarter to date for that is as of the reporting date.
Speaker Change #134: Okay.
Speaker Change #134: Okay.
Speaker Change: And so that's I think that covered all of the questions.
Speaker Change #134: Hello.
Speaker Change: Yes.
Speaker Change #134: Yeah.
Yeah. Thanks, so much for that.
<unk> Divan: The next question comes from <unk> Divan from Guggenheim Securities.
Speaker Change: Then I guess the second question is could.
Speaker Change: Could you maybe provide some additional color on the phase III open label extension data for <unk>, how does the data inform the treatment gap in timing for starting a second course of therapy.
<unk> Divan: Please go ahead.
<unk> Divan: Yeah.
Speaker Change #136: Great. Thanks for taking my question. So I just had one other follow up on the change the $4 seven could you probably understand the dynamic there. So those patients are already receive the product. It's just a matter of getting the reimbursement now.
Speaker Change: Also our the data consistent with what Youre seeing in a real world. Thank.
Speaker Change: Thank you so much I'll hop back in the queue.
Speaker Change #137: Hitting the payment there is no risk that they may.
Speaker Change: So the data will be presented at the upcoming era EDTA.
Speaker Change #138: You may not end up getting the product I just wanted to.
Speaker Change: And I think that as we mentioned in the press release.
Speaker Change #139: I confirm that if you could.
Speaker Change #139: And then my other question is on.
Speaker Change: What we've seen is kind of consistent trends and patterns that we saw in the original phase III trial.
Speaker Change #140: Yes, so the prescriber base that you are seeing obviously, a nice increase in the number numerous scrubbers.
Speaker Change: So I think that we'll be happy to kind of take more questions or discuss is maybe more at the R&D day when that when we when we cover some of those aspects as well and where we will be joined by professor Barnes.
Speaker Change #140: Is there any change that you're seeing now in terms of which sorts of prescribers are.
Speaker Change #141: Writing the product given the broader label.
Speaker Change #142: Just thinking in terms of academic group.
Speaker Change #143: Based positions versus more community based doctor, so any sort of insights in terms of where the prescriptions are coming from now would be would be helpful. Thank you.
Speaker Change: Yes.
Speaker Change #143: Mario you want to take that sure. So maybe I'll first address your first question unchanged health. So change health is one of the larger.
Speaker Change: Okay.
Speaker Change: Hello.
Speaker Change: The next question comes from <unk> Divan from Guggenheim Securities.
James: James processes in the U S. They process approximately one third of U S lives.
Speaker Change: Please go ahead.
Speaker Change #145: And the way. It works is that every single time, you have a new claim as you need to get a new prescription either new patients are in existing patients that it's going to get another <unk> <unk>.
Great. Thanks for taking my question. So I just had one other follow up on the change the $4 seven could you probably understand that.
Speaker Change #145: Shipment.
Speaker Change: Dynamics there. So those patients are already receive the product, it's just a matter of getting the reimbursement now.
Speaker Change #146: You shouldnt they need in our pharmacy need to confirm.
change health: That the patient still has coverage from their insurance and that is what change health is providing to their online.
Speaker Change: And in the payment there is no risk today.
Speaker Change: Not end up getting the product I just wanted to.
Speaker Change #148: System and ask the system was down.
Speaker Change: I confirm that if you could.
Speaker Change: And then my other question is on.
<unk> had some issues in terms of verifying insurances.
Yes, so the prescriber base and Youre seeing the obviously a nice increase in our maneuver scrubbers is there any change that you're seeing now in terms of.
Speaker Change #149: I want to reassure you that all patients.
Speaker Change #149: Are have still received drug we didn't lose any patient per se, but it did provide a bit of a delay of approximately 10 days when we were unable to verify the insurance for the patients, but that's why Rene mentioned early adapt.
Speaker Change: Which sorts of prescribers are.
Speaker Change: Writing the product given the broader label.
Speaker Change: Shifting in terms of academic group.
Speaker Change: [noise] based physicians versus more community based doctor, so any sort of insight in terms of where the prescriptions are coming from would be helpful. Thank you.
Speaker Change #150: And the revenue will is not lost that it's going to come in over the coming months or is that a catch up on that that gap that we experienced in the first quarter.
Mario: Mario you want to take that sure. So maybe I'll first address your first question unchanged health. So change health is one of the larger claims processes in the U S. They process approximately one third of U S lives.
Speaker Change #151: And with regards to your second question of prescribers.
Speaker Change #152: We're very happy that we're seeing both new prescribers, but also existing prescribers prescribing traditional patients.
Mario: And the way. It works is that every single time, you have a new claim as you need to get a new prescription either new patients are in existing patients that is going to get another <unk>.
Speaker Change #153: I don't think we've seen any change in terms of academic versus community Nephrologists, but we've always had prescriptions coming from both both groups about.
Mario: Shipment.
Speaker Change #153: I guess, you can say that.
Danny: Sure Danny are farmers that need to confirm.
Speaker Change #153: Both seeing healthy growth in terms of new prescribers, but also in the existing prescribers identifying additional patients.
Danny: That the patient still has coverage from their insurance and that is what change health is providing to their online.
Speaker Change #154: Okay, Alright, thank you very much.
Danny: System and asked the system was down <unk>.
Speaker Change #154: Welcome.
Danny: You've created some issues in terms of verifying insurances I want to reassure you that all patients.
Speaker Change #155: The next question comes from Eagle from now come of it.
Speaker Change: Our silversea drug we didn't lose any patient per se, but it did provide a bit of a delay of approximately 10 days. When we were unable to verify the insurance limitation on spot that's why Rene mentioned earlier that in.
Speaker Change #156: Please go ahead.
Ross: Hi, This is Ross your company Ralph Thanks for taking our questions.
Ross Ralph: Im just wondering what youre expecting for the updated Katanga guidelines I'm, assuming that will broaden the definition about the at risk population and reflect the updated label language I'm. Just curious what you would expect will be specifically included if you really view that as a sales inflection point.
And the revenue will is not loss that it's going to come in over the coming months or is that a catch up on that that's got to face stares in the first quarter.
Speaker Change: And with regards to your second question so prescribers.
Ross Ralph: Especially with.
Speaker Change: We're very happy that we're seeing both new prescribers, but also existing prescribers prescribing to additional patients.
Speaker Change #159: New prescribers.
Speaker Change #159: Yes. So I think we are we are expecting.
Speaker Change #160: Eagle guidelines to at least come up for public review at some point in time in Q3.
Speaker Change: I don't think we've seen any change in terms of academic versus community Nephrologists, but we've always had prescriptions coming from both both groups about.
Speaker Change #161: And I think that there have we have no knowledge of exactly what is going to be in those guidelines, but what we have heard and we'll be observing different conferences and interactions with a lot of Kols is clearly that there is a concern generally that the existing level of one gram per Gram may.
Speaker Change: I guess you can say that we are both seeing healthy growth in terms of new prescribers, but also in the existing prescribers identifying additional patients.
Speaker Change: Okay, Alright, thank you very much youre welcome.
Speaker Change #161: May not kind of truly reflect the correct patient population is being defined as being at risk.
Speaker Change: The next question comes from Eagle from now come of it.
Speaker Change #161: So I think there is a a kind of a in our view a significant probability that that level may be reduced to what level I don't think that we know.
Speaker Change: Please go ahead.
Ralph: Hi, This is Russia company, Ralph Thanks for taking our questions.
Speaker Change #162: But certainly I think that would obviously just further broaden the kind of target market.
Speaker Change: I'm, just wondering what youre expecting for the updated contango guidelines I'm, assuming that will broaden the definition about the at risk population and reflect the updated label language I'm. Just curious what you would expect will this be specifically included and if you really view that as a sales inflection point.
Speaker Change #163: As in our label it does cover patients that are considered to be at risk.
Speaker Change #164: Okay understood and then in terms of European store at this point I guess, we're waiting for.
Ralph: Especially with the.
Ralph: New prescribers.
Speaker Change #165: Some of your commentary I'm, just curious what the remaining.
Speaker Change: Yes. So I think we are we are expecting the kid Eagle guidelines to at least come up for kind of public review at some point in time in Q3.
Speaker Change #165: Steps are the.
Speaker Change #165: Any reason to think that you might push back on a full approval or is it your expectation that every biggest contributes more filling from this model.
Speaker Change: And I think that there have we have no knowledge of exactly what is going to be in those guidelines, but what we have heard and we will be observing different conferences and interactions with a lot of kols is clearly that there is a concern generally that the existing level of one gram per Gram may.
Speaker Change #166: It is our expectation that we that can paygo will receive a positive opinion from EMA, however, as all regulatory processes.
Speaker Change #167: You kind of never know until you know and there is you can never be sure of what's exactly going to happen, but that would certainly be our expectation.
Speaker Change: It may not kind of truly reflect the correct patient population being defined as being at risk.
We're hopeful that email will.
Take this up on their agenda in our upcoming meeting so if that is the case.
Speaker Change: So I think there is a a kind of in our view a significant probability that that level may be reduced to what level I don't think that we know.
Speaker Change #168: There is a possibility that there would be a positive opinion fairly shortly and then obviously there is that kind of 66 to seven day kind of delay between a positive opinion and the actual kind of formal decision by the European Commission.
Speaker Change: But certainly I think that would obviously just further broaden the kind of target market.
Speaker Change: As in our label it does cover patients that are considered to be at risk.
Speaker Change #169: Got it thank you very much.
Speaker Change #169: Thank you.
Speaker Change: Okay understood and then in terms of European store at this point I guess, we're waiting for.
Speaker Change #169: Yeah.
Speaker Change: Some of your commentary I'm, just curious what the remaining.
Speaker Change: Steps are the if there's any reason to think that there that you might push back on a full approval or if it was your expectation that everything should be smooth sailing from the spun off.
Annabel <unk>: The next question comes from Annabel <unk> from Stifel.
Annabel <unk>: Please go ahead.
Speaker Change: It is our expectation that we that can paygo will receive a positive opinion from EMA, however, as all regulatory processes.
Annabel <unk>: Hi, everyone. Thanks for taking my question. So just following on the canine goes island guidelines.
Annabel <unk>: You did mentioned that.
Speaker Change #171: Those things.
Speaker Change: You kind of never know until you know there is you can never be sure of what's exactly going to happen, but that would certainly be our expectation.
Speaker Change #172: The guidelines Argus here potentially identifying the at risk population, but you said that it could.
Speaker Change #173: Also include par payoffs specifically.
Speaker Change: And we're hopeful that email will.
Speaker Change #174: As as a potential treatment.
Speaker Change: Take this up on their agenda in our upcoming meetings if that is the case.
Speaker Change #175: Do you have any sense as to how they might talk about term payout.
Speaker Change: There is a possibility that there would be a positive opinion fairly shortly and then obviously there is that kind of 66 to seven day kind of delay between a positive opinion and the actual kind of formal decision by the European Commission.
Speaker Change #175: Within these guidelines.
Speaker Change #175: And then secondly.
Speaker Change #176: I was just curious you know we've all been.
Speaker Change #177: Focus on how long patients are staying on fitness, whether it's below nine months about nine months.
Speaker Change #178: But it is really the wrong way of thinking about it or are you now using this nine months treatment period is selling points I guess, especially in light of the competitive environment that seems to be evolving with only chronic therapies.
Speaker Change: Got it thank you very much.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change #179: Available for these patients so.
Speaker Change: The next question comes from Annabel <unk> from Stifel.
Speaker Change #179: Or are possible for these patients. So can you just talk about I guess higher uhm nine months treatment period as the possible selling point as opposed to.
Annabel <unk>: Please go ahead.
Annabel <unk>: Hi, everyone. Thanks for taking my question. So just following on the <unk> guidelines guidelines.
Speaker Change #179: Sort of a guideline for treatment.
Speaker Change #179: Yeah.
Speaker Change: You did mentioned that.
Thanks, So with regards to the clinical guidelines.
Speaker Change: Guidelines obvious here potentially identifying the at risk population, but you said that it could.
Speaker Change #180: We are clearly expecting to our payer to be part of the guidelines.
Speaker Change #180: And I think that the guidelines obviously are based on kind of scientific evidence, which is ranked <unk>.
Speaker Change: Also include payoffs specifically.
Speaker Change: As as a potential treatment.
Speaker Change #181: Based on kind of like by a third party really who provides the author with that kind of a ranking and so we believe obviously that our data is very strong.
Speaker Change: Do you have any sense as to how they might talk about term payout.
Speaker Change: Within these guidelines.
Speaker Change #181: And that it will be recognized in the guidelines in terms of the fact that we have.
Speaker Change: And then secondly.
Speaker Change: I was just.
Speaker Change: <unk> evolving.
Speaker Change #182: Really in our view kind of a disease modifying.
Speaker Change: Focus on how long patients are staying on treatment, whether it's nine.
Speaker Change #183: Immuno modulating effect on B cells.
Speaker Change: Nine months about nine months.
Speaker Change #183: And so this is something that we would expect to hopefully be reflected in the guidelines, but as to exactly how that treatment paradigm will be expressed and discussed we don't at this point in time.
Speaker Change: But it is really the wrong way of thinking about it are you now using this nine months treatment period as a selling point I guess, especially in light of the competitive environment that seems to be evolving with <unk>.
Speaker Change #183: Have any insights into how that exactly what would be kind of described.
Speaker Change: Chronic therapies.
Speaker Change: Available for these patients so.
Speaker Change #183: In terms of nine months and I'll have mario's comment on that I guess my view is actually that.
Speaker Change: Or are possible for these patients. So can you just talk about I guess higher use from that nine months treatment period as the past.
Mario: There is a very significant benefit from Ah patient population from a patient perspective with sometimes they think is forgotten in some of these conversations.
Speaker Change: Selling point as opposed to.
Speaker Change: Sort of a guideline for treatment.
We're obviously in a vast majority of patients are actually diagnosed between the ages of tiny and 40, 40% of these patients are female.
Speaker Change: Thanks, So with regards to the clinical guidelines. So obviously, we are clearly expecting to our payer to be part of the guidelines.
Mario: And for from pretty much most or if not all of these kinds of treatments there.
Speaker Change: And I think that the guidelines obviously are based on China's scientific evidence, which is ranked <unk>.
Speaker Change #185: There is an issue in terms of becoming pregnant. If you are on any of these chronic treatments I think that this is actually an extremely important issue for a very large and important part of this patient population. So yes, I do think that there could be a very substantial benefit.
Speaker Change: Based on kind of like by a third party really who provides the author without kind of a ranking.
Speaker Change: So we believe obviously that our data is very strong.
Speaker Change: And that it will be recognized in the guideline in terms of the fact that we have.
Speaker Change: Really in our view kind of a disease modifying.
Of actually being able to hopefully delay dialysis keep patients out of dialysis, hopefully with intermittent treatment rather than forcing all patients to be kind of a chronic treatment from a kind of for sales perspective Orient you have any comments.
Speaker Change: Immuno modulating effect.
Speaker Change: On B cells.
Speaker Change: And so this is something that we would expect to hopefully be reflected in the guidelines, but as to exactly how that treatment paradigm will be expressed and discussed we don't at this point in time.
Speaker Change: Have any insight into how that exactly what would be kind of described.
Speaker Change #186: Yes, so I would say.
Speaker Change #187: It's two things I mean first Gino.
Speaker Change: In terms of nine months and I'll have <unk> comment on that I guess my view is actually that.
Speaker Change #188: No the what our label says is that the recommended.
Speaker Change: There is a very significant benefit from a patient populate from a patient perspective with sometimes they think is forgotten in some of these conversations.
Speaker Change #189: Our duration is nine months of therapy.
Speaker Change #190: And that is also what we provide in all of our promotional materials in all of our communications to our field teams.
Speaker Change: Or obviously the vast majority of patients are actually diagnosed between the ages of tiny and 40, 40% of these patients are female.
Speaker Change #191: We also know from market research that this is something that patients appreciate good basketball Tony mentioned before this is a lifelong disease.
Speaker Change: And for from pretty much most storage not all of these kind of treatments.
Speaker Change #192: Young patients can be seen in market research that patients.
Speaker Change #193: Really appreciate this nine months course with extended benefits.
Speaker Change: There is an issue in terms of becoming pregnant. If you are on any of these chronic treatments I think that this effectively an extremely important issue for a very large and important part of this patient population. So yes, I do think that there could be a very substantial benefit.
Speaker Change #193: And.
Tony: But that is something that they see us as a benefit in treating their their disease. So it's definitely something that is appreciated by by patients for what we can see and also something that physicians recognize.
Speaker Change: Of actually being able to hopefully delay dialysis keep patients out of dialysis hopefully with.
Speaker Change #195: When they were the prescribed for payout.
Speaker Change #195: Okay, Great and just one more follow up question on the <unk> guidelines do you have any analyze as to what kind of impact that could have one Andrew I guess specifically included in guidelines as oppose to just say.
Speaker Change: With intermittent treatments, rather than forcing all patients to be kind of on chronic treatment from a kind of a sales perspective Orient you have any comments.
Speaker Change: Yes.
Orient: I would say.
Speaker Change #196: And our risk population with more general.
Speaker Change: It's two things I mean first.
Speaker Change #196: Okay.
Speaker Change #197: What I wish I did have something off the top of my head that I can provide you with is an excellent question, but.
That's what our label says is the recommended.
Speaker Change: Duration is nine months of therapy.
Speaker Change #198: But I don't necessarily have an analog but I do think obviously this is a rare disease and I think it is something where these nephrologists are not highly specialized in the subcategories of nephrology. So it's actually a very you know it's a it's quite a it's quite a feat to be nephrologist and cover everything that kind of relates to nephrology.
Speaker Change: And that is also what we provide in all of our promotional materials in all of our communications to our field teams.
Tony: We also know from market research that this is something that patients appreciate good basketball Tony mentioned before this is a lifelong disease.
Tony: Fairly young patients NBC in market research that patients.
So do you think that these guidelines are going to be very impactful because I do not think that many of the kols, who are often kind of may be interviewed or discussed in this kind of setting that they are very representative in terms of the broader nephrology community I. My guess is that the broader community nephrology community Nephrologist.
Tony: Really appreciate this nine months course with extended benefits.
Tony: And.
Tony: But that is something that they see us as the benefit in treating theyre there.
Tony: Rare disease. So it's definitely something that is appreciated by patients from what we can see and also something that physicians recognize.
It will very much appreciate and refer to the guidelines and to get some.
Tony: When they when they prescribe for payout.
Speaker Change: Okay, Great and just one more follow up question on the <unk> guidelines do you have any analyze as to what kind of impact that could have one enter I guess specifically included in guidelines as oppose to just say.
Speaker Change #198: Some insight into how they might treat these patients.
Speaker Change #199: Okay, great. Thank you.
Tony: In our risk population.
Tony: General.
Christopher <unk>: The next question comes from Christopher <unk> from Seb.
Tony: Okay.
Speaker Change: You know what I wish I did have something off the top of my head that I can provide you with is an excellent question.
Christopher <unk>: Please go ahead.
Speaker Change: But I don't necessarily have an analog but I do think obviously this is a rare disease and I think it is something where these nephrologist are not highly specialized in subcategories of nephrology. So it's actually a very it's a it's quite a it's quite a feat to be nephrologist and cover everything that it kind of relates to nephrology.
Chris <unk>: Hi, there Chris <unk> from Seb, Thanks, very much for taking my questions I just wanted him to chicken in terms of what.
What can you tell us about.
Speaker Change #202: The rate of conversion.
Speaker Change #203: In the quarter from.
Speaker Change #204: Enrollments to actually dispensing pneumatic medicines, and then I had a question on <unk>.
Speaker Change: So I do think that these guidelines are going to be very impactful because I do not think that many of the kols, who are often kind of may be interviewed or discussed in this kind of setting that they are very representative in terms of the broader nephrology community.
Speaker Change #204: <unk>.
Speaker Change #205: What are your thoughts preliminarily for a phase III trial design.
Speaker Change #206: When you go to to the FDA for an end of phase II.
In particular, I'm curious about the number of arms.
Speaker Change: My guess is that the broader community nephrology community Nephrologist will very much appreciate and refer to the guidelines and to get some lemon.
Speaker Change #207: But other comments would be great as well thanks.
Speaker Change #208: So with regards to kind of set and access.
Speaker Change #209: I think that obviously, we probably would not go to the FDA on our own with regards to kind of any progression on the oncology side.
Speaker Change: Some insight into how they might treat these patients.
Speaker Change: Okay, great. Thank you.
Speaker Change #210: Our preference would be to.
Speaker Change #211: Use this time right after the client clinical data to engage with potential partners with other interested partners and gain a bit of insight into which which way would kind of be the most effective and efficient way to kind of take this forward oncology as we don't have any plans to really kind of do that on our own I also think that if it's an anti fibrotic effect.
Speaker Change: The next question comes from Christopher <unk> from Seb.
Speaker Change: Please go ahead.
Speaker Change: Chris <unk> from Seb, Thanks, very much for taking my questions I just wanted to check in in terms of what <unk>, what can you tell us about.
Speaker Change #212: This obviously could very well have or it would be expected to have a very similar kind of effect and in solid tumors, such as pancreatic cancer et cetera. So there might be other kind of solid tumors that are partners would choose to kind of go into not necessarily just head and neck cancers. So so I think that this is something that we will enter.
Speaker Change: The rate of conversion and.
Speaker Change: In the quarter from.
Speaker Change: Uh huh.
Speaker Change: Enrollments to actually dispensing pneumatic medicines, and then I had a question on <unk>.
Speaker Change: Certain acts.
Speaker Change: What are your thoughts preliminarily for a phase III trial design.
Speaker Change #213: <unk> for the variety of parties, which we have plans to do over the next kind of couple of months.
Speaker Change: When you go to the FDA for an end of phase II.
Speaker Change #213: And really I think on the basis of that we will we will kind of jointly decide on kind of what the.
Speaker Change: In particular, I'm curious about the number of arms.
Speaker Change: But other comments would be great as well thanks.
Speaker Change #214: What steps, we may or may not take.
Speaker Change: So with regards to kind of set and access.
Speaker Change #215: And the kind of near term related to oncology.
Speaker Change: I think that obviously, we probably would not go to the FDA on our own with regards to kind of any progression on the oncology side.
Speaker Change #216: Okay. Thanks, that's great.
Speaker Change #217: In terms of rate of conversions, we don't really provide any specifics around that.
Speaker Change: Our preference would be to.
Speaker Change #218: But obviously I think what we are kind of seeing and we can talk a little bit about kind of like potential market access friction that we're seeing today, yeah. So it's I would say.
Speaker Change: For us this time right after the client clinical data to engage with potential partners with other interested partners and gain a bit of insight into which which way would kind of be the most effective and efficient way to kind of take this forward oncology as we don't have any plans to really kind of do that on our own I also think that if it's an anti fibrotic effect.
Speaker Change #218: Awesome.
Speaker Change #219: The way I would look at it is that we have a very strong demand for our payer we get a lot of enrollment forms as you've seen from what we've reported today.
Speaker Change #220: In the U S patients need to go through the prior authorization process, where we verify the benefits sce's their payer will cover for appeal.
Speaker Change: This obviously could.
Speaker Change: Very well have or it would be expected to have a very similar kind of effect in solid tumors, such as pancreatic cancer et cetera. So there might be other kind of solid tumors that partners would choose to kind of go in June and not necessarily just head and neck cancer. So so I think that this is something that we will.
Speaker Change #220: This is Jason we are in right now is that we have a full approval label with a broad label.
Speaker Change #220: But as we mentioned.
Jason: Not all of the payers have updated their policies at some of the largest payers we expect to update their policies mid year, which is why we have guided.
<unk> for the variety of parties, which we have plans to do over the next kind of couple of months.
Speaker Change: And really I think on the basis of that we will we will kind of jointly decide on kind of what the.
The second half of the year is going to have a stronger revenue.
Jason: So we don't provide a specific conversion rates and how quickly are patients converting from an enrollment form two on therapy, because it depends on the type of Ms Uropathy Hot.
Speaker Change: <unk>.
Speaker Change: We may or may not take.
Speaker Change: And the kind of near term related to oncology.
Speaker Change: Okay. Thanks, that's clear.
Speaker Change: In terms of rate of conversions, we don't really kind of provide any specifics around that.
Speaker Change #222: But I think the way I would look at it is we have a very strong demand, which I think is the lead indicator for future growth and future revenue for the past.
Speaker Change: But obviously I think what we are kind of seeing in that we can talk a little bit about kind of like potential market access friction that we're seeing today, yeah. So it's I would say.
Speaker Change #223: Alright, thanks very much.
Speaker Change #223: Okay.
Speaker Change #223: Yes.
Speaker Change #224: The next question comes from Suzanne Van Vasu Eisen from V. L. K. Please.
Speaker Change: Yeah.
Speaker Change: The way I would look at it is that we have a very strong demand for our payer we get a lot of enrollment forms as you've seen from what we've reported today in.
Speaker Change #225: Please go ahead.
Speaker Change #225: Okay.
Speaker Change: In the U S patients need to go through the prior authorization process, where we verify the benefits.
Speaker Change #226: Hi team thanks for taking my questions.
Speaker Change #227: First of all can you comment on the operating expenses, how should we think about how those will develop coming time for both R&D and SG&A.
Speaker Change: <unk> their payer will cover for appeal.
Speaker Change: This is Jason we are in right now is that we have a full approval label a broad label.
Speaker Change #227: And.
Speaker Change #228: Perhaps especially with regards to the sales and marketing expenses.
Speaker Change: But as we mentioned.
Speaker Change #228: Can you clarify what drove the increase in yeah, what how to think about the run rate going forward.
Speaker Change: Not all of the payers have updated their policies at some of the largest payers we expect to update their policies mid year, which is why we have guided.
Speaker Change #229: And then I have a follow up question.
Speaker Change: The second half of the year is going to have a stronger revenue.
Speaker Change #230: Yes, Thank you I'll take that.
Speaker Change #231: So starting with R&D cost us.
Speaker Change: So we don't provide a specific conversion rates and how quickly are patients <unk> from an enrollment form two on therapy, because it depends on the type of Mr. Apathy.
Speaker Change #231: As I said earlier.
Speaker Change #232: We expect.
Speaker Change #232: Expect some lumpiness between quarters on the R&D costs up overall for the year.
But I think the way I would look at it as we are.
We expect them to be broadly in line with.
A very strong demand, which I think is the lead indicator for future growth and future revenue for the past.
Previous year.
Speaker Change #233: And for the sales and marketing expenses.
Speaker Change: Yeah.
Speaker Change #100: Alright, thanks very much.
Speaker Change #233: Sure.
Speaker Change #100: Yeah.
Speaker Change #234: What we're seeing now.
Speaker Change #100: Yes.
Speaker Change #234: From Q4 to Q1.
The next question comes from Susan Van Vasu Eison from V L. K.
Speaker Change #235: Stand alone.
Speaker Change #236: I think it was around 20% the increase in AR.
Speaker Change #237: I believe you should think that we have now taken I mean, most of our investments and I believe that the first quarter.
Speaker Change #101: Please go ahead.
Speaker Change #101: Yeah.
Speaker Change #102: Hi team thanks for taking my questions.
It's kind of.
Speaker Change #103: First of all can you comment on the operating expenses, how should we think about how those will develop coming time for both R&D and SG&A.
Speaker Change #237: Representative.
Speaker Change #237: I would think.
Speaker Change #237: For the year, you should expect kind of a.
Speaker Change #237: 52.
Speaker Change #103: Perhaps especially with regards to the sales and marketing expenses.
Speaker Change #237: 20%.
Speaker Change #238: <unk> strong from the level over from last year.
Speaker Change #104: Can you clarify what drove increase in yeah.
Speaker Change #104: How to think about the run rate going forward.
Speaker Change #239: Got it that's very clear and then maybe a question on for the next ship them now with the recent data in oncology signaling a potential anti fibrotic effects.
Speaker Change #104: And then I have a follow up question.
Speaker Change #105: Yes, Thank you I'll take that.
Speaker Change #106: So starting with R&D cost us as I said earlier.
Speaker Change #240: For the upcoming Readouts can you give some context on what you would like to see there.
Speaker Change #106: We expect.
Speaker Change #106: Expect some lumpiness between quarters on the R&D costs up overall for the year.
Speaker Change #241: I'm, the interim futility and PVC is probably straightforward.
Speaker Change #106: We expect them to be broadly in line with.
Speaker Change #241: Yeah, maybe some thoughts that you can share on the IPF data.
Speaker Change #106: Previous year.
Speaker Change #106: And for the sales and marketing expenses.
Speaker Change #241: The study design, there and thereafter outboard data.
Speaker Change #241: What would be a senior view.
Speaker Change #106: Sure.
Speaker Change #106: What we've seen from Q4 to Q1 is kind of the law.
Speaker Change #241: So I think in terms of the PBC, obviously overall right now apart from.
Speaker Change #107: I think it was around 20% the increase in AR.
Speaker Change #242: The endpoints and the secondary endpoints I mean, we also in that we are looking at things like fiber scan.
Speaker Change #107: I believe you should think that we have now taken I mean, most of our investments and I believe that the first quarter.
Speaker Change #243: That would obviously be another really interesting kind of component of kind of validating this.
Speaker Change #107: It's kind of.
Speaker Change #243: Anti fibrotic effect.
Speaker Change #107: Representative.
Speaker Change #107: So I would think.
Speaker Change #243: So I think there'll be quite a lot on the PBC data that will complement what we've seen kind of from the.
Speaker Change #107: For the year, you should expect Jundollah.
From kind of the head and neck cancer trial.
Speaker Change #107: 52.
Speaker Change #107: 20%.
IPF. Obviously is is a really interesting and I think we as we reported out I mean, we've also seen in the interim readout from the head and neck cancer. We saw that that was one of the pathways that was modulate it in that kind of smaller group of patients.
<unk> strong from the level over from last year.
Speaker Change #108: Got it that's very clear and then maybe a question on <unk> now with the recent data in oncology signaling a potential anti fibrotic effects.
Speaker Change #244: And so I think that would obviously be something that's very exciting the drug trial is being run right. Now as you know is an investigator led study.
Speaker Change #109: For the upcoming Readouts can you give some context on what you would like to see there.
Speaker Change #110: I'm, the interim futility and PVC is probably straightforward but.
Speaker Change #245: And it's also run a day kind of half the dose of what were using in our other clinical trials.
Speaker Change #111: Yeah, maybe some thoughts that you can share on the IPF data.
Speaker Change #246: But clearly I think any signal that we could get from that in terms of efficacy would be really exciting.
Speaker Change #112: The study design, there and thereafter outboard data.
Speaker Change #247: And so this is obviously, what we're hoping that we can get to see that data kind of in Q4 of this year, we will spend a little bit more time on this clearly in our R&D day. So the whole point really have the R&D day is to provide a little bit more thinking about this we will take you through all of the kind of different designs in the pipeline.
Speaker Change #113: What would be in your view.
Speaker Change #114: So I think in terms of the PBC, obviously overall apart from.
Speaker Change #114: The endpoints and the secondary endpoints. We also in that we are looking at things like fiber Sam.
Speaker Change #114: That would obviously be another really interesting kind of component of kind of validating this.
Speaker Change #248: And I think obviously also talk a little bit more about what we might be expecting to see or what we would think would be kind of a.
Speaker Change #114: Anti fibrotic effect.
Speaker Change #114: So I think there'll be quite a lot on the PBC data that will complement what we've seen kind of from the.
Speaker Change #248: Positive to see but I think generally in the PBC.
Speaker Change #114: From kind of the head and neck cancer trial.
Speaker Change #249: I would say apart from the obvious kind of things I think really it's a fiber scan that we're really interested in seeing and I think also really be.
Speaker Change #114: IPF. Obviously is is a really interesting and I think as we reported out I mean, we've also seen in the interim readout from the head and neck cancer. We saw that that was one of the pathways that was modulate it in that kind of smaller group of patients.
Speaker Change #250: Possibility of having a statistically significant effect on fatigue, I think is something else that we'd be very excited to see so I think that those are probably the two things.
Speaker Change #114: I think that would obviously be something that's very exciting the drug trial is being run right. Now as you know is an investigator led study and it's also run a day kind of half the dose of what were using in our other clinical trials, but.
Speaker Change #251: Got it thank you very much.
Johan <unk>: The next question comes from Johan <unk> from Redeye.
Speaker Change #114: But clearly I think any signal that we could get from that in terms of efficacy would be really exciting.
Johan <unk>: Please go ahead.
Speaker Change #253: Taking all request and took a few add on.
Speaker Change #114: And so this is obviously, what we're hoping that we can get to see that data kind of in Q4 of this year, we will spend a little bit more time on this.
Johan <unk>: You mentioned that one.
Speaker Change #254: Private insurance.
Speaker Change #255: PMT Committee has taken a decision already and do you expect several to follow by midyear July portal, what's your.
Speaker Change #114: Nearly in our R&D day, so the whole point really have the R&D day is to provide a little bit more thinking about this they will take you through all of the kind of different designs in the pipeline.
Speaker Change #256: What can we expect from that.
Speaker Change #114: And I think obviously also talk a little bit more about what we might be expecting to see or what we would think would be kind of a.
Speaker Change #257: Tobacco burden.
Speaker Change #257: Label and when you do you expect to see.
Speaker Change #257: Reimbursable without prior quarter.
Speaker Change #114: In a positive to see but I think generally in the PBC.
Speaker Change #258: Of course Asia Korea.
Speaker Change #114: I would say apart from the obvious kind of things I think really the fiber scan that we're really interested in seeing and I think it also really be.
Speaker Change #258: Yes.
Maria: Maria do you want to make sure so.
Maria: So the insurance company as you referred to is an artist healthcare they cover approximately 13 million U S lives they.
Speaker Change #114: Possibility of having a statistically significant effect on fatigue, I think is something else that we'd be very excited to see so I think that those are probably the two things.
Maria: They made an update to their policy in May.
Maria: It reflects our new label.
Speaker Change #115: Got it thank you very much.
Speaker Change #259: We have a broad inclusion criteria removal of UPC our criteria.
Speaker Change #260: The recognition of the impact on Egfr, so exactly in line with what we expected.
Speaker Change #116: The next question comes from Johan <unk> from Redeye.
Speaker Change #260: Yeah.
Speaker Change #261: I still believe that for payable will require prior authorization and the majority of cases that is very typically the U S.
Speaker Change #117: Please go ahead.
Speaker Change #118: Taking our questions with a few add on.
Speaker Change #119: You mentioned that one.
Speaker Change #261: Most rare disease highly specialized drugs have a prioritization and the majority of cases.
Speaker Change #120: Private insurance.
Speaker Change #121: PMT Committee has taken a decision already and do you expect several to follow by mid year July portal, what's your.
Speaker Change #262: But I think the anticipated.
Speaker Change #263: The positive change that we are anticipating is that it will be easier to get that first approval because they are.
Speaker Change #122: What can we expect from that.
Speaker Change #122: On the back of burden.
Speaker Change #263: Their policies will be aligned to our label so.
Speaker Change #122: Table when you do you expect to see.
Speaker Change #263: But it will still require prior authorization or expectation.
Speaker Change #263: Okay.
Speaker Change #123: Reimbursement without prior.
Great and you also expanded your commercial team and the support team.
Speaker Change #123: Sure.
Speaker Change #123: Of course creation story.
Speaker Change #123: Yeah.
Speaker Change #264: Whom I believe partly to support this review and.
Speaker Change #124: Maria do you want to make sure so.
Speaker Change #125: So the insurance company as you referred to as genetic health care, they cover approximately $13 million use slides.
Speaker Change #265: Of course work with it.
Specialist can you, perhaps give us some more flash what that requires or what do you walk away into since the teammates in place since February I believe.
Speaker Change #126: They made an update to their policy in May.
Speaker Change #126: Which reflects our new label.
Speaker Change #126: So we have a broad inclusion criteria removal of UPC our criteria.
Speaker Change #265: Yes.
Speaker Change #265: Of course, so we we.
Speaker Change #126: The recognition of the impact on Egfr, so exactly in line with what we expected.
Speaker Change #266: We took the decision in Q3 last year to expand our field team.
Speaker Change #267: And some other type of functions in anticipation of a board approval.
Speaker Change #126: Yeah.
Speaker Change #126: I still believe that for payables will require prior authorization and the majority of cases that is very typical in the U S.
Speaker Change #268: We now have today.
Speaker Change #269: 70, <unk> rare disease account managers. So these are sales specialists in the field.
Speaker Change #126: Most rare disease harvest specialized strikes have the prioritization in the majority of cases.
Speaker Change #270: We have in addition.
Speaker Change #271: Hired Saucony Dolby Atmos, we have expanded our market access teams in terms of bringing in house, our field reimbursement managers and our national account managers and we've also expanded some of our home office functions and marketing.
Speaker Change #126: But I think the anticipated.
Speaker Change #126: The positive change that we are anticipating a start it will be easier to get that first approval because they are there.
Speaker Change #126: Their policies will be aligned to our label so.
Speaker Change #126: But it will still require prior authorization or expectation.
Speaker Change #271: Port.
Speaker Change #126: Okay.
Speaker Change #272: Our field team with with materials and also the digital efforts. So in total we now have approximately 100 people in the field in the U S to support the full approval and.
Speaker Change #127: Great and you also extended your commercial team and the support team.
Speaker Change #128: Whom I believe partly to support it.
Speaker Change #129: A review and.
Speaker Change #273: The promotion of <unk>.
Speaker Change #129: Of course block.
Speaker Change #130: Specialist can you, perhaps give us some more flash what that requires or where do you walk away. Since the team is in place since February I believe.
Speaker Change #274: Okay excellent and finally.
Speaker Change #275: From our side.
Speaker Change #276: The cyber attack it seems to be.
Speaker Change #277: Well, even though it was substantial especially on the change health care side, perhaps you can give.
Speaker Change #129: Yes.
Speaker Change #129: So we.
Speaker Change #131: We took the decision in Q3 last year to expand our field team.
Speaker Change #278: I'll give some feel for it.
Speaker Change #131: And some other several functions in anticipation of a board approval.
Speaker Change #279: What do you sort of what you measures you've taken on the preparation of something.
Speaker Change #131: We now have today.
Speaker Change #131: 70, <unk> rare disease account managers. So these are sales specialists in the field.
Speaker Change #280: Similar would happen again.
Speaker Change #281: So I think obviously this is a third party provider and then obviously once some when these things happen Theyre always quite a lot of follow up activities, particularly on the change health side.
Speaker Change #131: We have in addition.
Speaker Change #131: Hired thought leader liaisons are we have expanded our market access teams in terms of bringing in house, our field reimbursement managers and our national account managers and we've also expanded some of our home office functions and marketing.
Speaker Change #282: I mean, we know from kind of.
Speaker Change #283: They've been actually also gone to Congress and have kind of to explain themselves as to what happened there etcetera. So I think on their side. They have certainly announce that they are they have taken action to try to avoid that this can happen again, but exactly what those details are we are not privy to.
Speaker Change #131: Port.
Speaker Change #131: Our field team with materials that also the digital efforts. So in total we now have approximately 100 people in the field in the U S to support the full approval on.
Speaker Change #283: Okay.
Speaker Change #284: Yes, and is there something that you have done on your side to grab.
Speaker Change #131: The promotion of Tara payout.
Speaker Change #285: Ups and mitigate.
Speaker Change #132: Excellent and finally.
Speaker Change #285: Yeah.
Speaker Change #133: From our side.
Speaker Change #286: This vision change or.
Speaker Change #134: The cyber attack it seems to be.
Speaker Change #287: Good morning.
Speaker Change #288: We can't really do anything because it's really kind of biologics that cover our hub.
Speaker Change #135: Well, even though it was substantial especially on the change health care side, perhaps you can give.
Speaker Change #289: So we can only kind of try and collaborate with them and look at their systems et cetera, what they might do but actually it's very difficult to do anything as a kind of a third party because obviously this really relates to the situation of the change hub.
Give some feel for it.
Speaker Change #136: But you sort of.
Speaker Change #137: What you measures you've taken in preparation if something.
Speaker Change #288: Yeah.
Speaker Change #137: Similar would happen again.
Speaker Change #288: Thank you. Thank you.
Speaker Change #138: So I think obviously this is a third party provider and then obviously once some when these things happen there always quite a lot of follow up activities, particularly on the change health side.
Speaker Change #288: Okay.
Speaker Change #288: The next question comes from Rami Cuda from Nice Ci capital.
Speaker Change #138: I mean, we know from kind of.
Rami Cuda: Please go ahead.
Speaker Change #138: They've been actually also gone to Congress and have kind of to explain themselves as to what happened there et cetera, I think on their side. They have certainly announced that they are they have taken actions to try to avoid that this can happen again, but exactly what those details are we are not privy to.
Rami Cuda: Hi, guys. Congrats on the progress and thank you for taking my questions as well.
Rami Cuda: I guess for certain enacted do you have any hypotheses of why you didn't see changes from baseline in tumor size in conjunction I guess with the PFS and OS benefit and then did you measure the Cps score for these patients and could those values have been influenced the overall results.
Speaker Change #138: Yeah.
Speaker Change #138: Yes.
Speaker Change #139: It's something that you have done on your side too.
Rami Cuda: Richard.
Sean: Hi, Sean.
Speaker Change #139: <unk> mitigate.
Richard: I think in this kind of assessing of what we were evaluating where looking at his treatment on top of Penn release, Your map pember lithium app itself.
Speaker Change #139: Yeah.
Speaker Change #139: Vis vis change or.
Speaker Change #139: Net barrel cost.
Speaker Change #139: We can't really do anything because it's really kind of biologics that cover our hub.
Richard: It's not typically a drug that we would use to that is used to shrink achievements, what you see as the longer term benefits in terms of progression.
Speaker Change #139: So we can only kind of try and collaborate with them and look at their systems et cetera, what they might do but actually it's very difficult to do anything as a kind of a third party because obviously this really relates to the situation of the change.
Richard: Progression free survival and overall survival with <unk> and what we're seeing at Cessna sit on top of that as we're seeing.
Speaker Change #140: Yeah. Thank you. Thank you.
Speaker Change #292: Evidence of patients when they respond.
Speaker Change #140: Okay.
More patients.
Speaker Change #293: Preceding assessment acceptance achieved stable disease.
Speaker Change #141: The next question comes from Rami Cuda from Nice Ci capital.
Speaker Change #293: And those responses when they are achieved more.
Speaker Change #142: Please go ahead.
Speaker Change #293: Sure.
Speaker Change #293: So.
Speaker Change #294: I think I think Ivy.
Rami Azeez Katkhuda: Hi, guys. Congrats on the progress and thank you for taking my questions as well.
Speaker Change #295: When we were setting up the study.
Rami Azeez Katkhuda: I guess for certain active do you have any hypotheses of why you didn't see changes from baseline in tumor size in conjunction I guess with the PFS and OS benefit and then did you measure the Cps score for these patients and could those values have to influence the overall results.
Speaker Change #296: You know progression free survival ideally might've been chosen as the primary endpoint, but we also have to approach it from a feasibility point of view.
Speaker Change #296: What's reasonable from a sort of sample size calculation point of view.
Speaker Change #297: Change in tumor size is a sensitive way.
Rami Azeez Katkhuda: Richard.
Sean: Hi, Sean.
Speaker Change #297: Ah protecting.
Speaker Change #145: I think in this kind of assessing of what we were evaluating.
Speaker Change #297: Ah clinical effect, so from sample size point of view, it's a kind of.
Speaker Change #146: Looking at his treatment on top of <unk> release, you map pember lithium app itself.
It was a pragmatic decision to use at any point.
Speaker Change #147: Is not typically a drug that we would use to that is used to shrink achievements, what you see along with some benefits in terms of.
To allow a reasonable size to study in a feasible study, but nevertheless, we had sufficient passage check changes in PFS and indeed, that's what we did so overall in summary, what we're saying is.
Speaker Change #147: Progression free survival and overall survival with releasing map and what we're seeing when we add <unk> on top of size was saying.
Speaker Change #297: Is it kind of.
Speaker Change #298: Increase in patients with C, achieving at least stable disease, and the durability of those responses being longer in patients who receive certain exit.
Speaker Change #147: Evidence of patients when they respond.
Speaker Change #147: More patients.
Speaker Change #147: Saving assessment acceptance achieved stable disease.
Speaker Change #299: If there's anything that would indicate we did have a cps score requirement to get into the study.
Speaker Change #147: And those responses when they are achieved.
Speaker Change #147: No.
Speaker Change #147: Sure.
Speaker Change #147: So.
Speaker Change #300: But I don't think Theres anything there.
Speaker Change #148: I think I think Ivy.
Speaker Change #300: That would indicate patients responding differently.
Speaker Change #148: When we were setting up the study.
Speaker Change #300: With respect to that baseline Cps score, while we do see.
Speaker Change #148: Progression free survival ideally might've been chosen as a primary endpoint, but we also have to approach it from a feasibility point of view and.
Speaker Change #301: Is that when patients receive treatment with <unk> said, we see evidence from heritage behind markers.
Speaker Change #148: And what is reasonable from a sort of sample size calculation point of view.
Speaker Change #302: And transcriptome Mcnellis fees that we see an increase in the immunological activity of the tumor.
Speaker Change #148: Change in tumor size is a sensitive way.
Speaker Change #148: Protecting.
Speaker Change #302: Yeah.
Speaker Change #148: Ah clinical effects. So from sample size point of view is it.
Got it that makes sense and then I guess switching gears a bit to have the baseline characteristics of patients being prescribed SAR payout changed at all with the full approval or is it still too early to tell.
Speaker Change #148: It was a pragmatic decision to use at any point.
Speaker Change #148: To allow a reasonable sized study in a feasible study, but nevertheless, we had sufficient passage check changes in PFS and indeed, that's what we did so overall in summary, what we're seeing is.
Speaker Change #302: Hi.
Speaker Change #303: Well great question.
Speaker Change #304: I think if you look at the patients that we received prior to the full accrual, but did receive patient set the bar below the one five that was the cutoff.
Is it kind of.
Speaker Change #148: Increase in patients with C, achieving at least stable disease, and the durability of those responses being longer than patients who received certain exit.
Speaker Change #305: So I think we're seeing a broader you know it's early it's early days, but we're definitely seeing a broader group of patients being prescribed to store payroll and I think you can see that in the enrollment numbers.
Speaker Change #148: If there's anything that would indicate we did have a cps score requirement to get into the study.
Speaker Change #305: That they've reported.
The physician stops.
Speaker Change #306: As previously prescribed to one patients may have a second patient now that is eligible for treatment. So we're starting to see the positive sign I think it's too early to say.
Speaker Change #148: But I don't think Theres anything there.
Speaker Change #148: That would indicate patients responding differently.
With respect to that baseline Cps school, while we do see.
Speaker Change #306: The type of patient.
Speaker Change #307: What does the profile look like us it's only a few months.
Speaker Change #148: Is that when patients receive treatment with <unk>, we see evidence from various biomarkers.
Speaker Change #308: The new label.
Speaker Change #308: Okay.
Speaker Change #309: Sounds good thank you very much.
Speaker Change #148: And transcriptome Mcnellis fees that we see an increase in the immunological activity of the tumor.
Speaker Change #309: Thanks.
Eric <unk>: The next question comes from Eric <unk> from Carnegie.
Speaker Change #148: Yeah.
Speaker Change #149: Got it that makes sense and then I guess switching gears a bit to have the baseline characteristics of patients being prescribed SAR payout changed at all with the full approval or is it still too early to tell.
Eric <unk>: Please go ahead.
Okay.
Eric <unk>: Other.
Eric <unk>: Thanks, a lot for taking my questions and congrats on the progress.
Speaker Change #149: Hi.
Speaker Change #311: Two questions from my side.
Speaker Change #150: Well great question.
Speaker Change #150: I think.
The first maybe for Richard on the Mac said.
Speaker Change #151: If you look at the patients that we received prior to the full accrual, but did receive patients set the bar below the one five of the cutoff.
Speaker Change #312: The next day. So I was just wondering if you have discussed the data with any.
Speaker Change #151: So I think we're seeing a broader you know it's there.
Richard: The opinion leaders.
Speaker Change #151: It is early days, but we're definitely seeing a broader group of patients being prescribed restart payroll and I think you can see that in the enrollment numbers.
If you're getting any initial feedback on on the PFS and OS data.
More specifically the clinical irrelevance over two months extension of the PFS and <unk> would be helpful come down also.
Speaker Change #151: We've reported.
Speaker Change #152: The physician stops.
Speaker Change #152: Is that prescribed to one patients may have a second patient now that is eligible for treatment. So we're starting to see the positive sign I think it's too early to say.
Richard: Ron.
Speaker Change #313: We would expect to see the peer reviewed publication for the data or any presentation at the scientific meeting.
Speaker Change #152: <unk>.
Speaker Change #152: The type of patient.
Speaker Change #153: What does the profile look like US you still have a few months.
Speaker Change #314: And then finally.
Speaker Change #153: The new label.
<unk>.
Speaker Change #153: Okay.
Speaker Change #314: Sure.
Speaker Change #154: Sounds good thank you very much.
Speaker Change #315: I was just wondering if you could update us a bit on the competitive situation.
Speaker Change #153: Thanks.
Speaker Change #315: Hello.
The competitive programs in the clinic book, we should monitor thank you.
Speaker Change #155: The next question comes from Eric <unk> from Carnegie. Please.
Speaker Change #156: Please go ahead.
Speaker Change #316: Okay, Yes, so definitely we spoken to.
Speaker Change #156: Okay.
Eric <unk>: Other thanks, a lot for taking my questions and congrats on the progress.
Speaker Change #317: External experts.
Speaker Change #318: We also have.
Speaker Change #158: Two questions from my side.
Speaker Change #319: Very experienced people working with us.
Speaker Change #159: The first maybe for Richard on the <unk> had the negative thoughts though.
Speaker Change #320: Works in large pharma oncology settings.
Speaker Change #321: From that point of view and from the external expert point of view. They consider these outcomes in terms of progression free survival.
Speaker Change #160: I was just wondering if you have discussed the data with any the opinion leaders.
Speaker Change #160: You're getting any feedback on on the PFS and OS data.
Speaker Change #321: Impressive.
Speaker Change #322: I think one of the.
Speaker Change #160: More specifically the clinical irrelevance over two months extension of the PFS or and have you said it wouldn't be helpful come down also.
Speaker Change #323: Reassuring things that we observed as the patients who were randomized to placebo and received pember lithium out of the behavior of those patients in terms of these <unk>.
Speaker Change #161: When we could expect this as the peer reviewed publication.
Speaker Change #323: The term outcomes like PFS, which is exactly as has been seen in other studies. So we know that.
Speaker Change #161: Data or any presentation of the scientific meeting.
Speaker Change #324: Control alarm was behaving Barry.
Speaker Change #325: Very expected way, there's nothing unusual about that control arm. So we are seeing an augmentation apparent augmentation of benefit when we obsess in Mexico on top of that treatment of jets definitely those outcomes are considered impressive.
Speaker Change #161: And then finally.
Speaker Change #162: So this is.
Speaker Change #163: I was just wondering if you could update us a bit on the competitive situation.
Speaker Change #162: Hello.
Speaker Change #164: The competitive programs in the clinic, we should monitor thank you.
Speaker Change #326: We will be.
Speaker Change #327: Pairing application.
Speaker Change #328: And we will hope to present the data.
Speaker Change #165: Okay, Yes, so definitely we spoken to.
ESMO later this year.
Speaker Change #165: External experts.
Speaker Change #329: So regarding your question on PBC.
We also have.
Speaker Change #165: Very experienced people working with us.
Speaker Change #330: So obviously there is at this point in time really the dominant kind of.
Speaker Change #165: Works in large pharma oncology settings.
Speaker Change #330: Area in PBC.
Speaker Change #331: Being kind of focused on are are the kind of the <unk> at the moment era and kind of regulatory review.
Speaker Change #165: From that point of view and from the external expert point of view. They consider these outcomes in terms of progression free survival.
Speaker Change #332: I think that there is an expectation that both of those.
Impressive.
Speaker Change #333: Candidates may very well.
Speaker Change #165: I think one of the.
Speaker Change #165: Reassuring things that we observed as the patients who were randomized to placebo and received pember lithium map the behavior of those patients in terms of these <unk>.
Speaker Change #333: Achieve approval.
Speaker Change #333: This year.
Speaker Change #334: So I think that that's probably where the and I think there are other kind of similar <unk> kind of in in in kind of development I.
Speaker Change #165: The term outcome side, PFS, which is exactly as has been seen in other studies. So we know that.
Speaker Change #335: I would say that the way that we've obviously looked at kind of the PVC is not to kind of be an all comer for PBC. That's not the way. The trial is designed either so it's really kind of stratify for patients that have a higher score in terms of a reading of fiber scan.
Speaker Change #165: Control arm was behaving Barry.
Speaker Change #165: Very expected way, there's nothing unusual about that control arm. So we are seeing an orientation apparent augmentation of benefit when we obsess Max if on top of that treatment of them, Jeff definitely those outcomes are considered as impressive.
Speaker Change #336: So actually we have a trial that is specifically targeting a particular kind of patient group.
Speaker Change #165: We will be.
Speaker Change #336: And so I think from our perspective. This is really about looking at either of those patients that have a more kind of.
Speaker Change #165: Pairing application.
And we will hope to present the data.
Speaker Change #165: Asthma later this year.
Speaker Change #336: Compromised I guess kind of more fiber optic from the from the view of looking at fiber scan.
Speaker Change #166: So regarding your question on PBC.
Speaker Change #336: Kind of liver disease.
Speaker Change #166: Obviously, there is at this point in time really the dominant kind of.
Speaker Change #337: And or really looking at these patients in terms of fatigue, which is a really debilitating and very broadly.
Speaker Change #166: Area in PBC.
Speaker Change #166: Being kind of focused on are are the kind of the <unk> at the moment era and kind of regulatory review.
Speaker Change #337: Very broad kind of issue for all of these patients. So I think that those are the two kind of components that we really look at China complementing with them. So you are not.
Speaker Change #166: I think that there is an expectation that both of those.
Speaker Change #166: Candidates may very well.
Speaker Change #338: Not positioning ourselves as kind of.
Speaker Change #166: Achieve approval.
Speaker Change #339: Directly competing.
Speaker Change #166: This year.
Speaker Change #166: So I think that that's probably where the and I think there are other kind of similar <unk> kind of in in in kind of development I.
Speaker Change #340: The P powers or with op alive or for that matter, which is also why in this trial, we've actually allowed patients to come in with both look alive as well as better fiber et cetera. So.
Speaker Change #166: I would say that the way that we've obviously looked at kind of the PBC is not to kind of be an all comer for PBC. That's not the way. The trial is designed either so it's really kind of stratify for patients that have a higher score in terms of a reading of fiber scan.
Speaker Change #340: That that's really kind of a slightly different positioning that we have and those I think are still those two kind of drugs is really what I think the main focus of our footprint. If you anyone looking at PBC at the moment.
Speaker Change #166: So actually we have a trial that is specifically targeting a particular kind of patient group.
Speaker Change #341: Thank you so much.
Speaker Change #166: And so I think from our perspective. This is really about looking at either of those patients that have a more kind of.
Arthur <unk>: The next question comes from Arthur <unk> from H C. Wainwright. Please.
Speaker Change #166: Compromised I guess kind of more fibrotic from the from the view of looking at fiber scan.
Arthur <unk>: Please go ahead.
Arthur <unk>: Okay.
Arthur <unk>: Yes.
Speaker Change #166: Kind of liver disease.
Arthur <unk>: Hey, Renee and her team thanks for taking my question.
Speaker Change #167: Got it.
Speaker Change #167: And or really looking at these patients in terms of fatigue, which is a really debilitating and very broadly.
Speaker Change #343: Just had.
Renee: I had a quick one could you guys give us more color.
Renee: On the the launch in China for the <unk>.
Speaker Change #167: Very broad kind of issue for all of these patients. So I think that those are the two kind of components that we really look at China complementing with them. So we are not positioning ourselves as kind of.
Speaker Change #345: Africa, and I believe you still provide the drug as of now.
Speaker Change #346: How that is going to evolve in the upcoming years or quarters regarding that part. Thanks.
Speaker Change #167: Directly competing.
The <unk> win alive or for that matter, which is also why in this trial, we've actually allowed patients to come in with both look alive as well as better fiber et cetera. So.
Speaker Change #346: Yeah.
Speaker Change #347: Yes, so actually it's a little bit early for us to have any feedback really from from them and obviously it was launched.
Speaker Change #348: Really a week or two ago really kind of in China.
Speaker Change #167: Think that that's really kind of a slightly different positioning that we have and those I think are still those two kind of drivers is really what I think the main focus.
But it is something obviously that we're super excited about them and we're just as curious as you are in terms of.
Speaker Change #348: How that will develop.
Speaker Change #168: Joanna when looking at PBC at the moment.
Speaker Change #349: So the but yes, and obviously because China is not a rare disease and it's a much bigger patient population.
Thank you so much.
Speaker Change #350: In terms of supply you are correct, we are obviously not directly but through our existing Tennessee demo relationships.
Speaker Change #168: Yeah.
Speaker Change #170: The next question comes from Arthur <unk> from H C Wainwright.
Speaker Change #169: Please go ahead.
Speaker Change #351: We are providing.
Speaker Change #352: Supply also to China.
Speaker Change #169: Okay.
Speaker Change #353: And I don't see that changing in the near term. So my expectation would be that in the near term we would certainly still continue to to play that role.
Speaker Change #171: Hey, Renee and her team thanks for taking my question.
Speaker Change #171: I just.
Speaker Change #171: Had a quick one could you guys give us more color.
Speaker Change #171: On the <unk> the launch in China.
Speaker Change #354: Oh, great. Thanks, guys.
Speaker Change #171: Africa, and I believe you still provide the drug as of now.
Speaker Change #355: Okay. Thanks, a lot.
Speaker Change #356: And I think that was the last question.
Speaker Change #171: How is that going to evolve in the upcoming years or quarters regarding that part. Thanks.
Speaker Change #357: For this particular session.
Speaker Change #172: Yes, so actually it's a little bit early for us to have any feedback really from from them and obviously it was launched.
Speaker Change #172: Really a week or two ago really kind of in China.
Speaker Change #172: But we it is something obviously that we're super excited about them and we're just as curious as you are in terms of.
Speaker Change #172: How that will develop.
Speaker Change #172: So the but yes, and obviously because China is not a rare disease and it's a much bigger patient population.
Speaker Change #172: In terms of supply you are correct.
Speaker Change #172: We are obviously not directly but through our existing Tennessee BMO relationships.
Speaker Change #172: We are providing.
Speaker Change #172: Supply also to China.
Speaker Change #172: And I don't see that changing in the near term. So my expectation would be that in the near term we would certainly still continue to to.
Speaker Change #172: To play that role.
Speaker Change #173: Oh, great. Thanks, Renee I talked to you guys.
Speaker Change #174: Okay. Thanks, a lot.
Speaker Change #175: And I think that was the last question.
Speaker Change #176: For this particular session.
Speaker Change #176: Yeah.
Speaker Change #176: [music].