Q1 2021 Apellis Pharmaceuticals Inc Earnings Call
Good afternoon, My name is Sarah and I'll be your conference operator today at this time I would like to welcome everyone to the pellet Pharmaceuticals first quarter 2021 financial results conference call.
Sarah: Good afternoon. My name is Sarah, and I
Sarah: I'll be your conference operator today. At this time, I would like to welcome everyone to Apellis Pharmaceuticals.
Sarah: First Quarter 2021 Financial Results Conference Call. Today's call is being recorded, and a replay will be available soon.
Today's call is being recorded and a replay will be available at of pellets Dot com.
Sarah: 1 Financial Results Conference Call. Today's call is being recorded, and a replay will be available at Apellis.com. I would now like to turn the call over to Tracy Bunise, Vice President of Communications at Apellis.
I'd now like to turn the call over to Tracy for knees, Vice President of communications of out of Palace.
Good afternoon, and thank you for joining us to discuss the Pallas is the first quarter 2021 financial results with me on the call our co founder and Chief Executive Officer, Dr. Cedric Francois Chief.
Tracy Bunise: Good afternoon, and thank you for joining us to discuss Apellis's first quarter 2021 financial results. With me on the call are co-founder and chief executive officer, Dr. Cedric Francois, chief medical officer, Dr. Federico Grossi, chief commercial officer, Adam Townsend, and chief financial officer, Timothy Sullivan.
Medical Officer, Dr. Federico Grossi, Chief Commercial Officer, Adam Townsend, and Chief Financial Officer of kidney Sullivan.
Tracy Bunise: Before we begin, I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail.
Before we begin I would like to point out that we will be making forward looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially.
Courage you to consult the risk factors discussed in our SEC filings for additional detail.
Cedric Francois: Now, I'm pleased to turn the call over to Cedric.
Now I'm pleased to turn the call over to Cedric.
Thank you Tracy and good afternoon to everyone joining us today for our income from school.
Cedric Francois: Thank you, Tracy, and good afternoon to everyone joining us today for our conference. It is an exciting time at Apellis, with a potential U.S. approval of texitocopan and paroxysmal nocturnal hemoglobinuria, or PNH, just a couple of weeks away. We are fully prepared for our PDUFA date of May 14th and ready to launch Pexita Coplan shortly after approval. Our Chief Commercial Officer, Adam Townsend, will provide the latest updates on our efforts to ensure a successful launch in PMA.
It is an exciting time at our babies with the potential U S approval of fix it that goes on in bedrock system of nocturnal hemoglobinuria or peonage, just a couple of weeks of weight.
We are fully prepared for RP due dates of may 14th and ready to launch fixed debt coupland shortly after approval.
Our chief commercial officer, Adam Townsend will provide the latest updates on our efforts to ensure a successful launch M. P of age.
As this slide shows we are focused on advancing our global leadership income for them and their potential approval M. P of niche is just the starts for what will be a transformational year for us.
Cedric Francois: As this slide shows, we are focused on advancing our global leadership across continents, and our potential approval in PNH is just the start to what will be a transformational year for Atetti. With PNH as our lead indication, we aim to establish systemic dexethecotine, our targeted C3 therapy, as a disruptive treatment across rare, complement-driven diseases. We plan to become number one in the retina with the first treatment for geographic atrophy, and we continue to advance innovative technologies to control complement with a focus on complement factor C3.
With the NH as our lead indication, we aim to establish systemic fix it that goes on.
With the C three therapy.
Disruptive treatments across rare complement driven diseases.
We plan to become number one in the rest of the with the first treatment for geographic atrophy.
And we continue to advance innovative technologies to control complement with a focus on comes on the pictures of the tree.
Last month, we were thrilled to see results from our programs and H and the geographic axis or G published in three leading medical journals.
Cedric Francois: Last month, we were thrilled to see results from our programs in P&H and Geographic Atrocities, or GA, published in three leading medical journals. In PNH, results from our Phase III Pegasus Study were published in the prestigious New England Journal of Medicine. The recognition by NEJM underscores the importance of the Pegasus data to the PNH community and the high caliber of science that we are advancing at Apellis. Additionally, two separate analyses of our Philly study in GA were published in the American Journal of Ophthalmology and Ophthalmology.
In P N H results from our Phase III Pegasus study were published in the prestigious New England Journal of Medicine.
The recognition by any jam underscores the importance of the Pegasus data to the fee on each community and the high caliber of science that we are advancing at applebee's.
Additionally, two separate analyses are of a skinny study N. G. E were published in the American Journal of Ophthalmology and ophthalmology.
Our Chief Medical Officer, Dr. The city equaled Rossi will provide additional details nature, but together these publications showcase the broad.
Cedric Francois: Our Chief Medical Officer, Dr. Federico Grossi, will provide additional details later, but together, these publications showcase the broad platform potential of our targeted C3 therapy for complement-driven disease. The GA publications also reinforce our confidence in our upcoming Phase 3 readouts, which we continue to expect in the third quarter of this year. Top-line results from our DERBY and OCHS studies will be an important event for Apellis and for the more than 5 million people worldwide living with this relentless and disabling disease. Geographic atrocity is a leading cause of blindness and the most significant remaining unmet need in the West.
That's for and potential of our targeted free therapy for complement driven diseases.
The G. A publications also reinforce our confidence in our upcoming phase III Readouts, which we continue to expect in the third quarter of this year.
So at the end results from our Derby and Oaks. The studies will be an important event for the for the more than five millions of people worldwide living with this relentless and disabling disease.
Geographic atrophy is a leading cause of blindness in the most significant remaining unmet need in the rest of that.
We believe that targeting <unk> three has the potential to control the excessive complement activation responsible for the growth of <unk> and all of us that the needs are committed to advancing the first full page for treatment for people living with G E.
Cedric Francois: We believe that targeting C3 has the potential to control the excessive complement activation responsible for the growth of GA lesions, and all of us at Apellis are committed to advancing the first potential treatment for people living with GEA. Finally, our world-class researchers continue to develop new technologies to control complements. On June 30th, we will host an R&D day that will include new product candidates that we plan to advance into clinical development by the end of next year.
Finally, our world class researchers continue to develop new technologies to control of component.
On June 30, we will host an R&D day that will include the new product candidates that we plan to advance into clinical development by the end of next year.
These programs are focused on three key areas.
Cedric Francois: These programs are focused on three key areas: less frequent dosing while maintaining the strong clinical benefits seen in multiple studies of pexitacobalamin; second, treating all forms of AMD; and thirdly, exploring new indications in neurology. We look forward to sharing more details as we get closer to the event. As I mentioned earlier, 2021 is a transformational year for AdPedi. We have spent the past decade building the foundation for our leadership incompetence, and we look forward to seeing the results of those efforts come together over the next several months.
Less frequent dosing, while maintaining the strong clinical benefit seen in multiple studies so of fixed at the Goldman.
Secondly, treating all forms of energy.
And thirdly, exploring new indications in neurology.
And the ports to sharing more details as we get closer to visa.
As I mentioned earlier 2021 is a transformational year for our business. We have spent the past decade building the foundation for our leadership in company and we look forward to seeing the results of those efforts come together over the next several months.
And now I'd like to turn the call over to our Chief Medical officer booked or for the equal Brushy for a review of our pipeline updates beginning with our work to establish systemic fixes that Goldman as a disruptive therapy across their confidence.
Cedric Francois: And now I'd like to turn the call over to our Chief Medical Officer, Dr. Federico Grossi, for a review of our pipeline updates, beginning with our work to establish systemic Pexita-Cotlan as a disruptive therapy across rare, complement-driven diseases.
He says.
Yeah.
Thank you Cedric.
Federico Grossi: I will first begin with P&H, the program that serves...
I will first begin with teenage the program. The serves as the foundation of a variety of his franchise.
Federico Grossi: The program that serves as the foundation of a rare disease fund. We're all looking forward to our PDUFA date, and we remain on track for May 14th.
Well, we're all looking forward to a baidu for day and we made on track for May 14th.
The positive phase III.
Federico Grossi: The positive phase 3 Pegasus results demonstrated the potential effects of copyright to elevate the standard of care in PNH. And the recent publication by the New England Journal of Medicine reinforced the significance of these results for the medical community and patients with PNA. We hope to build on the strong clinical profile of Plexus decouplants seen to date with the upcoming results from the PIMMS study. As shown on this slide, our first preprint study in treatment in IBMH patients is designed to evaluate two primary endpoints at WIPS 20.
Salt demonstrated the potential effects of the compound.
To elevate the standard of care of M P of niche and.
The recent publication by the New York, New England Journal Medicine.
Enforced the significance of these results for the medical community on patients would be of niche.
We hope to build on the strong clinical profile of the Opex of the Copeland seem to date with the upcoming results from the study.
As shown on the slide of face to the clean study in treatment naive B and H patience is the sign to evaluate true primary endpoints at weeks 26.
Federico Grossi: Hemoglobin Stabilization in Diastasis and Transfusions and Reduction in LDH Levels. These co-primary endpoints were intentionally aligned with those used in previous PNH studies of C5 inhibitors and therefore focused on intravascular hemolysis.
The Mcglory of 70 stations in batches on transformations on reduction in LDH levels.
These co primary endpoints for it and essentially aligned with dose used in previous studies.
Studies, obviously, if I inhibitors on the.
Therefore focused on in for basketball of Hemolysis.
However, since being a true Scott.
Federico Grossi: However, since B&H is
The intra and extra vascular hemolysis.
Unknown Speaker: Thank you very much. I would also like to remind you that we set a high bar for
Believe that sorts of secondary endpoints, including hemoglobin levels.
Traditions of facets of the score.
Unknown Speaker: Thank you.
Critical measures of the overall impact of the species has on patients.
Unknown Speaker: 2013 University of Georgia College of Agricultural and Environmental Sciences UGA Extension Office In print, patients are considered to have unstable hemoglobin levels if those levels drop by only 1 gram per deciliter, whereas studies of C5 inhibitors historically allowed hemoglobin levels to drop by 2 grams per deciliter before being considered unstable. We're excited to see the results from PRINCE at the end of May or the beginning of June. I will now hand over the call.
I would also like to remind you that we set a high bar for banks of the top line on the primary endpoint for the time of the domains.
The only station compared to previous studies of C. Five behaviors.
Range basis, I'll consider like to hop unstable hemoglobin levels. It's also the level stopped by on the one gram per deciliter, whereas studies, obviously five inhibitors historically allowed from the blood levels dropped by two grams per deciliter the.
Before being conscious of the unstable.
We're excited to see the results for the planes at the end of May or the beginning of June.
I will now hand, the call all of our George Chief Commercial Officer, Alan Thompson to provide an update on the <unk> launch preparations.
Adam J. Townsend: I will now hand the call over to our Chief Commercial Officer, Adam Townsend, to provide an update on our P&H loan preparations.
Adam.
Thank you for a day.
Adam J. Townsend: FedA, our commercial organization, is excited and ready for our May-P-Doo for date, and we are laser-focused on ensuring a successful U.S. launch of Peg Setticoppelin in P&A. Our market research continues to reinforce the urgent need for new treatments for PNC. As you can see on this slide, people with PNH continue to suffer from significant unmet needs despite their current treatment with C5 inhibitors like celeris and altamirin. Retrospective studies show that one-third of patients on C5 inhibitors continue to require transfusions to address their falling hemoglobin levels.
First of all organization is excited and ready for a may produce the date and we are laser focused on ensuring a successful U S launch of <unk> Copeland N. P. N H on market research continues to reinforce the urgent need for new treatments for P. N. H as you can see on this slide people with P. N H continue.
To suffer from significant unmet needs. Despite the current treatment with <unk> inhibitors, like Soliris and Ulta mirrors.
Retrospective studies show that one set of patients on <unk> five inhibitors continue to require transfusions to address the falling hemoglobin levels. Another third of these patients remain anemic and experience other symptoms like severe fatigue.
Adam J. Townsend: Another third of these patients remain anemic and experience other symptoms like severe fatigue. The final third of patients on C5 inhibitors have hemoglobin levels closer to normal, but many only achieve that at the expense of maximum output of red blood cells from their bones.
The final set of patients on the <unk> five inhibitors have closer to normal hemoglobin levels, but many only achieve that at the expense of maximum output of red blood cells from net.
Thus, we believe there is of significant need for peg sets of culture and to elevate the standard of care in P. M H and our commercial team is ready to address the needs of people living with P. N H at launch.
Adam J. Townsend: Thus, we believe there is a significant need for Peg Setter-Coughlin to elevate the standard of care in PMAs, and our commercial team is ready to address the needs of people living with PNH at launch. Our latest launch preparedness activities are outlined on this slide.
Our latest launch preparedness activities are outlined on the slides.
All of value and access team is engaging with high priority payers, representing more than 80% of all U S. P N H patients.
Adam J. Townsend: Our Value and Access team is engaging with high-priority payers, representing more than 80% of all U.S. P&H patients. This includes completing more than 50 unique payer interactions, during which we received positive feedback on the clinical efficacy and safety profile of Pegstetter cops. On average, we anticipate that reimbursement decisions will be made approximately three to six months post-label.
This includes completing more than 50 unique payer interactions during which we received positive feedback on the clinical efficacy and safety profile of peg sets of Copeland.
On average, we anticipate that reimbursement decisions to be made approximately three to six months post launch.
We will work hard to make sure the any patient who chooses takes that the kauffman will have access to it from day one of our launch.
Adam J. Townsend: We will work hard to make sure that any patient who chooses Pegstetter-Coughlin will have access to it from day one of our life. We have established our distribution model as well as our patient support resources and programs. This includes Apellis Assist, a program designed to provide a comprehensive support system for patients throughout their treatment journey, including dedicated Apellis Care Education who will help train patients on self-administering peg cytokine. Apellis Assist will help ensure a high-quality treatment experience and provide infusion training, continuing education on the treatment of PNH, and ongoing support with Co-Pays, where eligibility criteria are met.
We have established our distribution model as well as our patient support resources and programs. This includes a palace the sixth a program designed to provide a comprehensive support system for patients throughout their treatment journey, including dedicated of pallets cat educators.
Who will help train patients from self administering peg sense of confidence.
The palace assessed will help ensure of high quality treatment experience and provide infusion training continuing education on the treatment of P. N H and ongoing support with co pay assistance, where eligibility criteria on that.
As we continue to navigate through COVID-19, our team both commercial and medical affairs is closely monitoring the regional COVID-19 restrictions in areas, where we can have in passing the engagements. We have field teams meeting health care professionals or hcp's in their offices.
Adam J. Townsend: As we continue to navigate through COVID-19, our team, both commercial and medical affairs, is closely monitoring regional COVID-19 restrictions. In areas where we can have in-person engagements, we have field teams meeting healthcare professionals or HCPs in their offices. And we will obviously remain diligent in following all appropriate guidance.
And we will obviously.
The main diligent and following all appropriate guidelines.
In the meantime, our commercial strategy remains focused on digital education, and the virtual engagements for both patients and Hcp's.
Federico Grossi: In the meantime, our commercial strategy remains focused on digital education and virtual engagements for both patients and healthcare professionals. We have built a very strong sales force with significant rare disease and hematology experience, and we believe our team has the right skill set to address any HCP access challenges in this COVID-19 environment. Finally, our focused and experienced sales teams are trained and, as of March 1, have been deployed to cover the top 1,000 to 2,000 HCPs, including more than 90 key treatment centers.
We have built a very strong sales force with significant rare disease in hematology experience and we believe our team has the right skill set to address any HCP access challenges in this COVID-19 environment.
Finally, I'll focus on experienced sales teams are trained and as of March. The first have been deployed to cover the top 1000 to 2000, hcp's, including more than 90 key treatment centers.
We have spent the last two years listening to and engaging with the <unk> community in preparation for all of the launch.
Federico Grossi: We have spent the last two years listening to and engaging with the P&H community in preparation for our launch. Our team has developed a very thoughtful and strategic approach to our launch, reaching first the patients with the highest unmet need and then transitioning to a broader group of patients. We await the decision from the FDA and are ready to elevate the standard of care with Pegsetter-Coughlin upon approval. In parallel to P&H, our commercial organization continues to plan for future potential approvals, and we are excited to see the results of our GA studies later this year. I will now turn the call back to our Chief Medical Officer, Dr. Federico Grossi, to review the additional systemic program indications as well as GH.
The team has developed a very thoughtful and strategic approach to our launch.
<unk> first the patients with the highest unmet need and then transitioning to a broader group of patients.
We await the decision from the FDA and are ready to elevate the standard of care with egg sets of Copeland upon approval.
In parallel to P. M. H, our commercial organization continues to plan for future potential approvals and we are excited to see the results of our GI studies later this year.
I will now turn the call back to our Chief Medical Officer, Dr. Federico grocery to review the additional systemic program indications as well as Gi Betty.
Thank you Adam.
Federico Grossi: Beyond P&H, we are advancing four registrational programs of systemic pexitocoplan with our partner SOPS. Our disease programs are focused on complement-driven diseases where patients have few or no treatment options and where we believe targeting C3 has the potential to offer a differentiated product profile.
The M P and H, whereas unseen for Registrational programs of systemic banks at the cop on with a partner of salt.
But where do you see as programs are focused on complement driven diseases, where patients have Q on.
Treatment options and where we believe targeting <unk> three has the potential to offer a differentiated product profile.
Federico Grossi: Key upcoming milestones are outlined on this slide, including several study initiations in the second half of this year. In parallel to our work in rare diseases, we continue to execute on our Phase III studies of intravitreal pexitococcalin in GA with top-line results expected in the third quarter. We're excited about the potential of Plexetocopin to become the first treatment for people with GH.
The upcoming milestones are outlined on this slide.
Including several of the study initiations in the second half of this year.
In parallel to our work in rare diseases, we continue to execute on our phase III studies of the interim each of Opex at the Copeland in G E with topline results expected in the third quarter.
We're excited about the potential effects of the pulp and to become the first treatment for people with D. A.
The recent publications in two leading ophthalmology Joel on us reinforce the clinical profile for for targeted therapy.
Federico Grossi: And recent publications in two leading ophthalmology journals reinforce the clinical profile of our targeted C3 therapy. Last month, publications in the Americal Journal of Ophthalmology, or AJO, and Ophthalmology highlighted post-shock analysis of a positive phase 2 field study of Pexotecoplan in GA. The AJL publication shows that Pexeta-Cocaine reduced lesion growth similarly across patient subgroups.
Last month for applications in the medical journal of Ophthalmology for a J L.
The Margie highlighted post hoc analysis of the positive phase III study of bits of the Copeland NGA.
On the AGL publication showed the effects of the broken with use of lesion growth seemingly across the patient subgroups and the results remained significant even when accounting for restructuring associated with more rapid progression.
Federico Grossi: And the results remain significant even when accounting for risk factors associated with more rapid progression. In the ophthalmology publication, the authors characterized the exudations reported in Philly and found that investigators determined exudations were responsive to standard anti-BTF therapy and did not have a clinically meaningful impact on vision. The analysis also found that exudations were more common in patients with a history of wet MD in the fellow eye. This observation is consistent with real-world clinical data mined from the A.O.
And the ophthalmology publication the power source characterized the explanations reported in Chile and found that the investigator determined extra nations, where we sponsored.
On the anti VEGF therapy, and did not have of clinical meaningful impact on vision.
The analysis also found that explanations for more common in patients with a history of wet AMD in the fellow eye.
This observation is consistent with real world clinical data mining from the Ale Irish registry in our ongoing collaboration with bear on the health.
Federico Grossi: Iris Registry in our ongoing collaboration with Verana Health. Earlier this month, we also announced that 10 abstracts, including five oral presentations from our artificial intelligence collaboration with the Medical University of Vienna's Optima Group, were accepted for presentation at the Association for Research in Vision and Ophthalmology, or ARBO, virtual annual meeting in May. Our strong presence at this important nostalgia meeting further showcases our leadership position in GA. Also in GA, we recently shared encouraging new 24-month data from our Phase 1B study of hexatocopium in patients with advanced GA and low-risk. The study, which enrolled patients with bilateral GER, is designed to assess the safety of the phase 3 formulation of Bexotacopin. Post-hoc analysis on eight patients from...
Earlier. This month, we also announced the 10 abstracts, including five core of presentations from the form of artificial intelligence collaboration with the medical University of BNS Optima group were accepted for presentation at the association for research in vision on the store margin both horrible.
The actual on your meeting in May.
Our strong presence at this important Lasalle margin meeting further showcases our leadership position in <unk>.
Also on G a release.
Since the share and crunching you 24 month data from the phase one B study of exit the copy on in patients with that kind of SGA on innovation the.
The study, which enrolled patients with bilateral G is designed to assess the safety of the phase III formulation affects of the coffee.
Cost of analysis on eight patients from on data warehouse of 24 months demonstrated of 46% decrease in means the lesion growth compared to the opposite and treated.
Federico Grossi: All home data were available at 24 months and demonstrated a 46% decrease in mean GA lesion growth compared to the opposite untreated eye. Of the 12 enrolled patients, there were no reported cases of inflammation, and two patients developed new onset exudation during the 24 months.
Of the 12 adult patients there were no reported cases of the inflammation and.
And two patients developed new onset of exploration during the 24 months study.
Federico Grossi: Thank you.
Federico Grossi: Patients were treated with anti-BGF therapy in combination with texetocotlin and experienced no clinical impact on vision. While this is a small study, these long-term results further highlight the potential of Plexus decoupling in this field. Together, this will solve some problems.
Patients were treated with anti VEGF therapy in combination with the exit of Copeland and explains non clinical impact on vision.
While this of small study this long term results for the highlights the potential of Brexit the Copeland and the species.
Together these results on publications continue to strengthen our belief in the GAA program ahead of.
Federico Grossi: Thank you. As shown on this slide, Derby and Oaks are multicenter, randomized trials.
For the pivotal phase III readouts of.
As shown on the slide there'll be a notes are multi center randomized controlled studies that compared the efficacy and safety of monthly on every other month interim each of the cooking with Shang chuang treatment in more than 1200 Gi patients.
Federico Grossi: Thank you very much. The primary endpoint of those studies is the reduction in growth of GA lesions at month 12. A full study of the signs can be seen on this slide. We are excited to see the top-line results from Derby and Oaks in the third quarter.
The primary end point of both studies is the reduction in gross of Ta nation at month 12.
Full of studying the science can be seen on the slides.
We're excited to see the top line results from Derby, and Oaks, and the third quarter.
Success here will position us as the neither in the treatment of retinal diseases.
Timothy E. Sullivan: Success here will position us as a leader in the treatment of retinal disease. I will now turn the call over to our Chief Financial Officer, Kim Sullivan, for a review of the financial results. End.
I'll now turn the call other George Chief Financial Officer, Tim Sullivan on for a review of the financial results.
King.
Thank you per day.
Timothy E. Sullivan: Since we issued a press release earlier today with our full financial results, I will just focus on the highlights for the first quarter of 2021. As of March 31, 2021, Apellis had $723.7 million in cash, cash equivalents, and short-term marketable security. Research and development expenses were $84 million for the first quarter of 2021 compared to $69.3 million for the same period in 2020. The increase in R&D expenses was primarily attributable to costs associated with ongoing and planned clinical trials, compensation, and related personnel costs, primarily due to the hiring of additional personnel, among others.
Since we issued a press release earlier today with our full financial results I will just focus on the highlights for the first quarter of 2021.
As of March 31, 2021 of Palace had $723 7 million in cash cash equivalents and short term marketable securities.
Research and development expenses were $84 million for the first quarter of 2021 compared to $69 3 million for the same period in 2020.
The increase in R&D expense was primarily attributable to costs associated with the ongoing and planned clinical trials compensation and related personnel costs, primarily due to the hiring of additional personnel among others.
General and administrative expenses were $40 6 million for the first quarter of 2021 compared to $29 5 million for the same period in 2020.
Timothy E. Sullivan: General and administrative expenses were $40.6 million for the first quarter of 2021, compared to $29.5 million for the same period in 2020. The increase in general and administrative expenses was primarily attributable to employee-related costs, professional and consulting fees, and general commercial preparation activities, among others.
The increase in general and administrative expenses was primarily attributable to employee related costs professional and consulting fees.
In general commercial preparation activities among others.
For the first quarter ended March 31, 2021 of the Palace reported the net loss of $183 7 million compared to a net loss of $168 8 million for the same period in 2020.
Cedric Francois: For the first quarter ended March 31, 2021, Apellis reported a net loss of $183.7 million compared to a net loss of $168.8 million for the same period in 2020. We remain well capitalized to execute on the potential launch of pegcetacoplin and PNH and continue to advance our robust clinical development. Our cash runway is expected to fund operations into the second half of 2022. I will now turn the call back over to Cedric for closing remarks.
We remain well capitalized to execute on the potential launch of it takes you the compound and <unk> and continued to advance our robust clinical development plans are.
Our cash runway is expected to fund operations into the second half of 2022.
I will now turn the call back over to Cedric for closing remarks.
Cedric Francois: Thank you, Tim. We've made strong progress this quarter and have several important commercial, clinical, and regulatory milestones anticipated over the next several months, as shown on this slide. With our PDUFA date for P&H just over two weeks away, we would like to take this opportunity to recognize and thank the patients, investigators, caregivers, partners, employees, and investors who have helped us get to this pivotal moment. We look forward to keeping you updated on our progress.
Thank you Tim we've made strong progress this quarter and have several important commercial clinical and regulatory milestones anticipated over the next several months as shown on this slide.
Whether it be deferred at four P. M. H just over two weeks away, we would like to take this opportunity to recognize and thank the patients investigators caregivers partners employees and investors, who have helped us get to this physical moments we the.
The towards the keeping you updated on our progress.
Cedric Francois: And now, operator, please open the call for questions. Thank you. To ask a question, you will need to press star then 1 on your telephone. To withdraw your question, please press the pound key. Again, that is Star, then 1 if you would like to ask a question. Our first question comes from the line of Anu Pam Rama with J.P. Morgan. Your line is now open. I was wondering if I could ask a question that I've been getting a lot recently, which is related to the Phase III geographic atrophy studies and how you're thinking about presenting some of the top-line data as it relates to exudates, whether it's the rate of exudation in the different arms or the portion of patients getting VEGF.
And now operator, please open the call for questions.
Thank you to ask a question you don't need the press Star then one on your telephone to withdraw your question. Please press the pound key again that is star then one if you would like to ask a question.
Our first question comes from the line of our new Panorama with J P. Morgan. Your line is now open.
The question I.
I was wondering if I could ask the question that I've been getting a lot recently, which is related to the phase III.
Geographic atrophy studies, and how youre thinking about presenting some of the topline data as it relates to extra data, whether it's the rate of <unk>.
<unk> in our in the different arms or the portion of patients getting of bedrock treatment or the rate of CMV and how we should be thinking about this and what are the most important important metrics on this topic related from.
Anupam Rama: Treatment, or the Rate of CNV, and how we should be thinking.
Anupam Rama: And how should we be thinking about this, and what are the most important metrics on this topic related to your market research from physicians? Thank you so much, Anupam, and it's great hearing your voice. So that is indeed a question that we get quite often.
From your market research from physicians.
Yeah.
Thank you so much underpinned the great hearing your voice.
So that is indeed, the question that we get quite often.
I think the first element to mention there is that we will report these expeditions.
Cedric Francois: I think the first element to mention there is that we will report these exudations as physician-reported exudations. So in that sense, very similar to how it was done in the Phase II clinical trial, with the caveat, as we have discussed many times before, that the Phase III clinical trial is better controlled to compensate for potential investigator bias, etc., and with the knowledge that in the Phase III clinical trial, the number of patients that came into the Derby and Oakes study, Demographically, we're much less represented by patients who started off the study with wet MD and 1I already at baseline, NGA and the contralateral I, because when we did the Philly study, the Phase II study, we were competing with another large Phase III program that was excluding that particular type of patient, and that matters because it is well known that patients with wet MD and 1I, NGA and the contralateral I have quite a high rate of exudation development, wet MD development in the GAI, based on a large study that we did to the extent of approximately 21% over the course of two years. I will also briefly hand it to Adam to give a brief feedback on what we have heard from physicians in terms of adoption. Thanks, Cedric, and thanks, Anupam.
Physician reported extraditions so in that sense, it's very similar to how it was done in the phase two clinical trial with the caveat as we have discussed many times before that the phase III clinical trial is better controls to compensate for potential investigator bias etcetera.
And with the knowledge that in the phase III clinical trial, the number of patients that came into the Derby and Oaks studies.
On demographically.
We're much less represented by patients who started off the study with wet in the in one I already at baseline and G. In the control of that rely on.
Because when we did the city study the phase II study, we were competing with another large phase III program that was excluding debt particular type of patients and that matters because of this well known that patients with wet AMD and when I N. G. On the control of that of rely of quite a high rates of.
The exhibition developments with MD development and the G I.
Based on the large study that we did to the extent of approximately 21% over the course of two years.
I will also briefly hand, it to Adam to give the brief of feedback on what we have heard from physicians in terms of the docs.
Thanks, Patrick and thanks <unk> so.
And our market research with the <unk>.
Adam J. Townsend: In our market research with GA physicians, be they injecting ophthalmologists or retina specialists, we find that some of the important impacts that resonate very well with them start with the ability to slow lesion growth. That's the number one piece that resonates very strongly. And then, if you use the parameters that we saw within our Philly study, we found that a clinically meaningful average based on our market research of lesion growth is about 20% to 30%.
<unk> physicians be day.
Injecting ophthalmologists are right in the specialists, we find that some of the important impacts the resonate very well with them starts with the ability to slow lesion growth. That's the number one piece of the resonates very strongly and then.
If you use the parameters that we saw within the filly study we found debt.
A clinically meaningful average based on our market research of of lesion less lesion growth is about 20% to 30% and we get that consistently true kols, the retinal specialists and ophthalmologists, so lesion size lesion growth.
Adam J. Townsend: And we get that consistently through KOLs, retina specialists, and ophthalmologists. So lesion size, lesion growth, and the ability to replicate some of the FIDI data are very strongly associated with our prescriber base. They also are very thoughtful about safety, dosing, roof administration, and mechanisms. One thing that is consistent is there's an emotional burden for these physicians who currently can't help these patients as much as they can. So we're excited to see the data towards the end of the year, and we hope to really, really have a big impact on GA patients moving forward. From a high level, maybe you could give us some perspective on your regulatory interactions here going into the P&H approval in terms of
And the ability to replicate some of the city data.
Very strongly with our prescriber base.
Also a very thoughtful around safety dosing route of administered.
Ministration and mechanism.
One thing that is consistent is that the emotional burden for these physicians, who currently con help these patients as much as they can so we're excited to see the data towards the end of the year and we hope to really really half of big impacts on Gi patients moving forward.
And then if I could just squeeze one more quick question and.
From a high level, maybe you could give us some perspective on.
Your regulatory interactions here going into the PMA approval in terms of I guess.
Anupam Rama: I guess there's a concern right now in Padova.
There's a concern right now on on.
Anupam Rama: Padufa is getting pushed out, given the kind of F2. Yeah, thank you so much. And of course, Anupam, we get a lot of questions on that as well. We are within two weeks of our PDUFA date, so we are not commenting on regulatory issues at this point in time. It is public knowledge that we went through the whole process without any major findings, and we are hopeful that by the middle of this month we will have something good to announce. Thanks so much for taking the questions, guys. Thank you. Thank you. Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open. Hi guys,
Paducah is getting pushed out given the kind of yeah.
Yeah. Thank you so much.
Of course, we get a lot of questions on debt as well we are within two weeks of LP due for it. So we are not commenting on regulatory questions at this point in time.
It is public knowledge debt.
No.
We went through the whole process without any major findings.
We are hopeful that the middle of this month, we will have something goods tune-ups.
Thanks, so much for taking the questions guys.
Thank you.
Thank you. Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open.
Hi, guys. Thanks, so much for taking the question.
Jonathan Miller: Thanks so much for taking the question. Two, one on the P&H launch and then a follow-up on GA, I guess. How are reimbursement discussions going for P&H launch at this point? You mentioned three to six months for commercial payers to get through the reimbursement process. Can you talk us through how you expect that payer ramp-up to happen and what percentage of those patients that you're talking about are commercial versus government, and what's the launch for government payers as well? All right, I'm going to hand that one over to Mr. Townsend, Adam.
Two one on the <unk> launch and then the follow up on G. A I guess.
Our reimbursement discussions going for Pn H launch at this point you mentioned.
The three to six months for commercial payers getting through the reimbursement process can you talk us through how you expect that payer ramp up to happen and what percentage of those patients that you're talking about a commercial versus government and whats the lunch up for for the government payers as well.
Yeah.
Alright, im going to hand that one over to Mr. Thompson Adam.
Yes. Thank you thanks, Jonathan the question so.
Adam J. Townsend: Yep, thank you. Thanks, Jonathan, for the question. So firstly, our value and access team is fully staffed and has been engaging with the high priority payers for the last couple of months. And those payers represent more than 80% of all US P&H lives. One thing that stands out from our pair interactions is that they've been hugely positive.
Firstly, our value and exit the team is fully staffed and has been engaging with the high priority payers for.
For the the last couple of months on those payers of representing a more than 80% of all U S. P. N H lives.
One thing that stands out from a payer interactions as they.
Been hugely positive we expect broad coverage.
Adam J. Townsend: We expect broad coverage, and we don't see any major issues with reimbursement. However, it does take, on average, between three and six months post-launch for us to work with those payers and get through their internal processes quickly.
And we don't see any major issues with reimbursement.
It does take on average between three and six months post launch for us to work with those payers and get through their internal processes.
And as a quick.
Adam J. Townsend: Sidestep to the second part of your question. 50% of the patients that we expect will have commercial private insurance, and the other 50% are governed under Medicare and Medicaid, with some slight error bars around them. We expect that on the Medicare plans, they typically take up to about 180 days, and the Medicaid plans up to about six months.
Sidestep to the second part of your question 50.
<unk> 50 per cent of the patients that we expect will have a commercial private insurance and the other 50% of government on the Medicare and Medicaid with some slight error bars around the edges.
We expect that on the Medicare plans, they typically take up to about 180 days.
Medicaid plans up to about six months and as I said before the commercial plans three to six months.
Adam J. Townsend: And as I said before, the commercial plans, three to four months. Our team is really, really impressive in how they've been interacting with the payers. The value story of PEC sets of companies is very, very high.
Team is is really really impressive and how they've been interacting with the past the value story of <unk> of companies very very strong. So we believe that will be out of smoothly moving three of those those discussions with the U S based pads and we're prioritizing access so any patient the wants to come on to our drug will be given the.
Jonathan Miller: So we believe that we'll be able to smoothly move through those discussions with U.S.-based payers, and we're prioritizing access. So any patient that wants to come onto our drug will be given access, even as we work through that payer landscape, as I've described. Great, that makes sense. And I guess, then, a follow-up on GA, I noticed that you highlighted some of that efficacy update you gave from the phase one safety study, but it looks to me like the efficacy delta we're seeing there has plateaued a little bit versus the last update. Obviously, still a very impressive headline number, but should we expect this to be the general observation with Teixeira-Copeland and GA?
Access even as we went through the payer landscape as I have described.
Great that makes sense I guess, then a follow up on G. A I noticed that you highlighted some of that debt efficacy updates you gave from the phase one safety study, but it looks to me like the efficacy of Delta. We're seeing there has plateaued a little bit versus the last update of.
This is still very impressive headline number but should we expect this to be the general observation with takes you to Copeland and G. A should we expect there to be this plateaued at around that 50% level or could that delta continue to expand dosing for days.
Cedric Francois: Should we expect there to be this plateau at around that 50% level, or could that delta be, Yeah, thank you so much, John. Again, that is a great question. Of course, by the way, or by the mechanism, I should say, in which Dexytacoplan works in geographic atrophy, we look forward to the readout from one year to two years. What we disclosed in that Phase 1b study was a very small sample set of patients.
Thank you so much John again that is a great question.
Of course by the way the provides.
For by the mechanism I should say.
Because at the coupon works in geographic atrophy, we look forward to the Readouts from one year to two years.
What we disclosed on the phase one B study is the very small simple set of patients that becomes very interesting. When you start looking on an individual patient level, even but.
Cedric Francois: It becomes, you know, very interesting when you start looking at individual patient levels even, but we are going to need the results from the larger studies to make a determination in that regard. All right, fair enough, Cedric.
But we are going to need the results from the larger studies to make a determination on that regard.
Alright fair enough. Thanks, a lot.
Jonathan Miller: Thanks a lot. Thank you, John. Thank you. Our next question comes from the line of Madhu Kumar with Goldman Sachs. Your line is now open.
Thank you John.
Thank you. Our next question comes from the line of Madhu Kumar with Goldman Sachs. Your line is now open.
Hey, guys. Thanks for taking our question, so I'll sort of with the Prince trial, how should we think about the Prince trial readout and <unk>.
Madhu Sudhan Kumar: Hey, guys, thanks for taking our questions. So I'll start with the PRINCE trial. How should we think about the PRINCE trial readout and what kind of impact it has on your P&H strategy? And kind of how contingent is that on what happens at the fiduciary?
What kind of impact could have on your P&L strategy and kind of how contingent is that on what happened, but the the Jupiter.
Thank you so much for the question, Matt So the Prince trial as we've mentioned many times before is the phase III clinical trial in treatment naive patients with Pn H that was very much designed to be there as an insurance policy.
Cedric Francois: Thank you so much for that question, Madhu. So the PRINCE trial, as we've mentioned many times before, is a phase three clinical trial in treatment-naive patients with PNH that was very much designed to be there as an insurance. Because when we did the Pegasus study, which was the Phase III clinical trial on which our approval is currently based, that was a study that aimed to do three things in one. First of all, to show that systemic pexitacopran was a treatment for PNH.
Because when we did the biggest the study which was the phase III clinical trial on <unk>.
Each of our approval is currently base that was the study that aimed to do three things in one first of all to show that systemic fixes. The coupon was the treatments for peonage seconds to show that it would be superior to show the res and number three to show that you could safely switch between the two of drugs in either direction.
Cedric Francois: Second, to show that it would be superior to soderies. And number three, to show that you could safely switch between the two drugs in either direction. And because that was a lot to handle for one trial, you know, we, of course, didn't know the outcome in advance. We wanted PRINCE to be there in case things did not go according to plan.
And because of that was a lot to handle for one trial.
Of course didn't know the outcome in advance we want the prints the b there in case things would not go according to plan as it turns out the things the study gave us.
Madhu Sudhan Kumar: Well, as it turns out, the Pegasus study gave us everything we had hoped for and then some. PRINCE there is now to really give us a snapshot of patients with PNH that are from a much more uniform background. So not patients with PNH on treatment with soderies that have, you know, what you could call suboptimal responses, but more representative of a broad population. And what we expect to see in PRINCE is, as we've seen in all of our studies so far, good control of PNH, as measured in this case by the measurement of lactate dehydrogenase control and stabilization of the hemoglobin level.
Everything we had hoped for and then some.
<unk> there is now to really give us the snapshots into patients with <unk> the dark from a much more uniform background, so not patients with <unk> on treatment with Soliris.
And have you know what you could call sub optimal responses, but more representative of the broad population and what we expect to see in Prince is as we've seen in all of our studies. So far good control of the in H as measured in this case by the measurement of lactate dehydrogenase control and stabilization of the hemoglobin.
Loans.
Okay great.
Madhu Sudhan Kumar: Okay, great. So I'll follow up with a question you're probably not going to be able to answer, but I have to try. But really, two questions. One, make the case for approval of the PEG-SUTECA plan outside of post-cellularist treatment in PMH, based on the data you have so far. And then, to what extent do you think there is a case for approval broadly in PMH, given the kind of design of PEG-SUTECA?
Follow up with the question, you're probably not going to be able to answer, but I gotta try but the two questions. One make the case for approval on pegs. The tech of playing outside of post Sameer as treatment in P. M. H based on the data you have so far and then to what extent do you think there is a case for approval brought.
Lee and <unk>, given the kind of design of Pegasus and payroll on pad of kind of altogether.
Madhu Sudhan Kumar: of Pegasus, and Ferola and Patek, all together.
So as you correctly assumed we cannot comment on the on label discussions at this point in time of course since we are only two weeks away from it.
Cedric Francois: So, as you correctly assumed, we cannot comment on label discussions at this point in time, of course, since we are only two weeks away from PDUFA. But, you know, we have commented in the past that we believe in the Pegasus study that we showed good control of PNH in a long period of treatment, I should say monotherapy, with Bexitech. Okay, then I'll have one go at a GA question. So how do you think about dose frequency for GA and the kind of similarities and differences to the treatment of geographic atrophy as compared to the treatment of wet AM? Thank you so much for that question, Madhu. So that is a the two are very different manifestations of probably a similar underlying disease process.
The <unk>.
We have commented in the best that we believe that in the Pegasus study we showed good control of <unk>.
And in the long period of treatment naive price.
I should say monotherapy with fixed type of plan.
Okay well on.
One go in and out of G. A question. So how do you think about dose frequency for gea and kind of the similarities and differences to the treatment of geographic atrophy compared to say the treatment of wet AMD.
Thank you so much for that question matters. So that is the.
The two are very different manifestations of probably a similar underlying disease process.
Madhu Sudhan Kumar: We've done a lot of work as it relates to understanding, I'd say, physician and patient receptivity to these two regimens. And I will hand the word to Adam in a minute as it relates to that. The bottom line is that currently, there is no treatment for geographic atheroclerosis, which is a debilitating and blinding disease affecting 5 million patients in the world. And it is a disease that, when it is treated, will not have the kind of immediate feedback to the physician as you have with an anti-PHF treatment, that the exfidates in the retina go away.
We've done a lot of work as it relates to understanding.
I'd say of physician and patient receptivity to these two regimens and I will hand, the word so adam in the minutes as it relates to that.
Bottom line is the currency there is no treatment for geographic atrophy, which is the ability and blinding disease affecting segment of patients in the world.
And it is a disease that when it will be treated as we will not have alcohol at the.
And of the immediate feedback for the physician as you have with an anti VEGF treatment that the extra dates and the rest of that go away. So this is a treatment that will much more rely on the positioning of the patients sticking to the prescribed regimen as we will establish it hopefully in our phase III clinical trends.
Cedric Francois: So this is a treatment that will much more rely on, you know, the physician and the patients sticking to the prescribed regimen, as we will hopefully establish in our phase three clinical trials. And where we are working on an artificial intelligence background, you will see much more about that at the ARVO conference as well, to be able to predict in patients with GA what is going to be the natural rate of photoreceptor cell loss in these particular patients and what a drug could do in order to slow that down. So I don't know, Adam, if you want to add something as it relates to monthly versus every other month. Yeah, thanks, Cedric.
And where we are working on the artificial intelligence backgrounds, you will see much more about debt at the.
ARVO conference as well to be able to predict and patients with G. What is going to be the natural rate of for the receptor. So loss in these particular patients and what could the drug to in order to slow that down.
Certain of Adam if you want to add something as it relates to the monthly versus every other month.
Yeah. Thanks, Cedric Thanks, Matthew so yet so obviously, the one thing that drives our excitement.
Adam J. Townsend: Thanks, Madhu. So yeah, obviously, the one thing that drives excitement is that we have the chance of being the first approvable product in GA, and currently, there is no treatment. So we get some great responses from retina specialists when we speak to them around dosing, and they're along these types of themes.
Is that we have the chance of being the first approvable product NGA and currently no treatment. So we get some great.
Responses from retina specialists, when we speak to them around dosing and Theyre along with these types of themes matters. So it's you know we get the I think monthly dosing is fine my my wet AMD patients.
Adam J. Townsend: So it's, you know, we could be, I think monthly dosing is fine. My wet AMD patients are motivated, and I can see GA patients being equally driven. And we also get comments about infrastructure, like we have the infrastructure to inject patients every month. So I think the excitement about current treatment gives us great options as we progress. And I'm just looking forward to seeing the data come out towards the end of this year.
Motivated and I can see gea patients being equally driven.
And we also get infrastructure comments like we have the infrastructure to inject patients every month. So I think the excitement about current treatment gives us great options as we progress of I'm, just looking forward to seeing that the day to come out towards the end of this year.
Alright, great. Thanks for taking the questions that I guess, we'll hear from the all in a couple of weeks.
Madhu Sudhan Kumar: All right, great. Thanks for taking our questions, and I guess we'll hear from y'all in a couple weeks. Thank you, Madhu. Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is now open. Hi Cedric and team, thank you very much for taking the questions.
Thank you Matthew.
Thank you. Our next question comes from the line of Geek out on a chunk of it let's Citigroup. Your line is now open.
Suddenly contain thank you very much for taking the questions.
I had two arms of day.
Regarding Derby and Oaks, if you get very good news on the third quarter on both the monthly on every other month end up being stat Sig.
Yigal Dov Nochomovitz: And then my second question was, if you could just explain the reasons why you're confident that pegylation isn't causing the exudations. Thank you. Thank you so much, Yigal.
It will be the commercial plan when you just move forward with the every other month since that's the lower treatment burden or for any reason why you would also want to market the monthly regimen.
And then my second question was if you could just explain the reasons why you are confident that the pegylation.
Causing the explanation. Thank you.
Thank you so much you got again two very good questions on.
Cedric Francois: Again, two very good questions. On geographic atrophy, I will again hand it to Adam, but it is worth mentioning that, based on everything we have seen, I think it's reasonable to expect a dose response, if you want to call that that. In other words, the efficacy of the monthly treatment is unlikely to be identical to every other month. So from that starting premise, that efficacy advantage would be something to take into account as it relates to commercialization. Adam, I don't know if you want to add something to that. No, I think you said it very well. I think they're both important for us to move forward.
On the geographic atrophy, I will again, and it's to Adam but it is worth mentioning debt based on everything we have seen.
I think it's reasonable to expect a dose response, if you want to call that in other words the efficacy for monthly is unlikely to be identical for every other month, so from that starting premise.
I guess the advantage wood.
It would be something to take into accounts as it relates to commercialization.
Adam I don't know if he wants to add something to that.
No I think you said it very well I think that most important for us moving forward.
Thank you Adam and then as it relates to the regulation.
Adam J. Townsend: Thank you, Adam. And then as it relates to the regulation, I think it is very important to point out that the few publications that are out there that have looked at polyethylene glycol as an agent that can promote exudations in certain models are highly artificial models. So, these are not animal models of macular degeneration. I'll give one example where they do a laser-induced ablation. So, essentially, you shine a laser in the retina, and you induce a type of wound that is, you know, going to be very much driven by digestion, and where polyethylene glycol may have an effect on how that wound healing occurs. That is, of course, very different from what we see in macular degeneration. And we do not believe that the polyethylene glycol that is part of dexethycoplan has an effect on the exudates in our patients.
So I think it is very important to point out that kind of the the <unk>.
Few publications that are out there that have looked at.
Fully ethylene glycol as an agent that promotes.
For the extra additions in certain models are highly artificial models. So these are not the animal models of macular degeneration I'll give you. One example, where the.
The laser induced ablation, so essentially you shine the laser in the retina and you induce a type of wounds that is going to be very much driven by the judge and where polyethylene glycol may have any effect on how that's wound healing of occurs that is of course very different from what we see in macular degeneration and we do not believe.
Is that the polyethylene glycol that as part of fixed at the coupon.
Has the effect on the exited.
Sure.
Got it thank you Cedric.
Yigal Dov Nochomovitz: Got it. Thank you, Seth. Thank you, Yigal.
Thank you Hugo.
Thank you.
Alethea Young: Thank you. Our next question comes from the line of Alethea Young with Cantor Fitzgerald. Your line is now open.
Our next question comes from the line of elite the of young with Cantor Fitzgerald. Your line is now open.
Okay. Thanks for taking my questions too.
Cedric Francois: Thanks for taking my questions, too. Obviously, GA's a big market, but can you just talk a little bit about physician feedback and how they think about segmenting it, practically speaking, just in light of, you know, the study that you're running? And then just, you know, as it relates to the U.S. and Europe, as it relates to PEG-C and Copeland, can you characterize, like, if there have been any kind of notable differences in, like, the EMA conversation versus the U.S.? Thank you so much, Alika. I will give the first part of that question again to Adam. Thanks, Alethea.
Can you just talk obviously, the big market, but can you just talk a little bit of.
Feedback on how they think about segmenting it practically speaking.
The study that Youre running and and then just you know.
As it relates to the U S and Europe as it relates to the pigs get of Cleveland.
Can you characterize like if there been any kind of notable differences in like the EMI conversation on the person.
Thank you so much on Egypt will give the first starts with the question again to the Adam.
Thanks, Alicia so yeah segmenting the market, obviously, a very sizable.
Adam J. Townsend: So yeah, segmenting the GA market, obviously, there is a very sizable patient demand there. So one thing we found that's been consistent is we expect the market to be segmented a little bit by Georgia size and location. So some of the clinical features that naturally resonate when you speak to physicians about treatment are, is the lesion central or non-central, and how big is the lesion, small, medium, or large? And then you find that you apply some patient parameters to that segmentation, and that seems to be consistent. They also take into account bilateral GA, et cetera, and patients with wet AMD. So lesion size and location and patient demographics are the way that we can see the segmentation occurring within the GA model.
Patient demand there. So one thing we found that's been consistent is that we expect the market to be segmented for little bit <unk> size and location. So some of the clinical features that naturally resonate when you speak to physicians about treatment is is the lesion central of non essential on how big is the lesion small media.
And then you find you.
You apply some patient parameters for that segmentation and that seems to be consistent they also take into account for.
Lateral G I.
Veteran on patients with wet AMD, so the Haitian size and location and patient demographic is is the way that we can see the segmentation of occurring within the market.
Thank you Adam and then as it relates to your second question Alethia So for.
Cedric Francois: Thank you, Adam. And then as regards your second question, Alitia, for questions related to European commercialization and the regulatory path for systemic pexitacoplan and PNH and the other indications, I would ask you to speak with SOBI directly. What I can tell you from our perspective is that this has been a fantastic partnership with no change in guidance as we set it out a couple of months ago. Yeah, I figured it was worth a try.
Or questions related to the European commercialization of the regulatory path.
On the systemic fixes the coupon in Pn H and the other indications I would ask you to speak with the sort of be directly.
Can't tell you from our perspective is that this has been fantastic partnership.
With no change in guidance as we set it out a couple of months ago.
Yeah, I figured it was worth a try.
Thank you.
Alethea Young: Thanks. Thank you. Thank you. Our next question comes from the line of Phil Nadeau with Cowen & Company. Your line is now open.
Sure.
Thank you. Our next question comes from the line of Phil Nadeau with Cowen and company. Your line is now open.
Non Derby and Oaks in the past you've been very good about giving updates on missed visits.
Philip M. Nadeau: And on Durban Oaks, in the past, you've been very good about giving updates on missed visits as COVID has waxed and waned. With the trials drawing to a close, I'd be curious if you have any updates on missed visits today. Are they still within the tolerances that you set out when you designed the trial and any update on your discussions with the FDA over how misvisits and mismeasures are going to be handled statistically?
COVID-19 has waxed and waned.
With the trial Charles drawing to a close I'd be curious if you have any update on on missed visits today.
Are they still within the tolerance is you sit out when you.
Just on the trial and any update on your discussions with FDA over how mis.
Mis visits.
On this measures are going to be handled statistically in the study.
Cedric Francois: Yeah, thank you so much, Phil. As you correctly mentioned, of course, this is something that has been top of mind for us since the spring of last year, and our guidance has not changed. So, ever since the spring of last year, when the trial came under control, even with the subsequent waves, etc., the patient visits and the injections, which we track on a weekly basis, are where we wanted them to be. We have had regulatory interactions with the FDA, and, you know, without providing any specific comments, we feel that both trials are well-powered to make us meet our primary endpoint in the third quarter.
Yeah. Thank you so much feels so as you correctly mentioned of course this is something that.
It has been top of mind for us since the spring of last year of of course.
Our guidance has not changed so ever since the spring of last year when the I'd say the day trial came under control.
Even with the subsequent waves etcetera of the patient visits and the injections, which we track on the weekly basis.
We are aware of where you wanted them to be.
We have had regulatory interactions with the FDA and we know without providing any specific comments, we feel that both trials are willpower to make us meet our primary endpoints in the third quarter.
I believe at your analyst meeting.
Philip M. Nadeau: I believe in your analyst meeting, you discussed a change to the statistics or how they're going to be handled with misvisits. Did I, am I mischaracterizing that? Are the statistics the same as initially designed, or has there been some sort of adjustment made for misvisits?
Discuss the change to the statistics.
Or how theyre going to be handled with missed visits right am I mischaracterizing that are the statistics. The same is initially designed or has there been.
Some sort of adjustment made it for the for missed visits.
Cedric Francois: Yeah, we have not changed the statistical analysis plan. And again, based on the control of the trial, we feel very good about the readout based on the existing.
Yeah, we have we have not changed the statistical analysis plan.
And again based on the control of the trial, we feel very good because of the readout based on the existing Sep.
Philip M. Nadeau: Perfect. Thank you.
Perfect. Thank you.
Philip M. Nadeau: And then, the second question on P&H, I guess, what are your most recent thoughts on pricing? What type of price would open up access the best or the most, and when will you disclose the price? Do you think you'd be in a position to disclose the exact price at the time of approval, or would you wait until until until the launch actually begins in our country?
Then.
Second question on ph.
I guess what are your most recent thoughts on pricing.
The type of price would open up access to the best for the most.
And when will you disclose the price competitive position to disclose the exact price at the time of approval or would you wait.
Until until the launch actually begins in earnest.
Cedric Francois: Thank you, Phil. I will hand that one over to Adam.
Thank you, Phil I will hand that one over to Adam.
Adam J. Townsend: Thanks for the question, Phil. So, yeah, we're committed, as I said, to ensuring that everything
Thanks for the question sales so yeah.
Yes, we can.
As I said to ensuring that every patient who wants to take such of Kauffmann can have access.
Adam J. Townsend: Yeah, we're committed, as I said, to ensuring that every patient who wants pexotococcaline can have access, regardless of their ability to pay, so we've made sure that that patient, For more information on PNH, please visit www.pnph.org. And we compared ourselves to the standard of care in PNH at the moment, so cilirus and ultimirus, as well as some other similar rare disease drugs
Regardless of their ability to pay so.
We've made sure that that patient access was the core of our pricing strategy in all of our work. So our pricing strategy involves benchmarking the clinical value that we believe that we can deliver to teenage patients.
And we compared ourselves to the standard of care in PMA for the moment of Soliris in Altamira as well as some other similar rates of these drugs.
As we get closer to our potential approval, we'll finalize our pricing in terms of our label and then post approval, we'll start to talk about the the value that we believe that we can have for peanuts patients so more to come.
Philip M. Nadeau: As we get closer to our potential approval, we'll finalize our pricing in terms of our label, and then, post-approval, we'll start to talk about the value that we believe that we can have for PNH patients. So, more to come. Perfect. Thanks for taking my question. Thank you so much. Thank you. Our next question comes from the line of Steve Seedhouse with Raymond James. Your line is now open. Yes, hi, this is Timur Ivanovic of ONN with Steve Seedhouse.
Perfect. Thanks for taking my questions.
Thank you so much for them.
Thank you. Our next question comes from the line of Steve Seed House with Raymond James Your line is now open.
Yes, Hi, this is the two more of on it goes on for Steve Steve House.
Timur Ivanovic: So, thank you for taking our question. So, we have a question about Pegasus. Do you think Pegasus alone provides enough data to prove that you have a robust effect on intravascular hemolysis since the primary endpoint was a change in hemoglobin? And then, relatedly, and not sure if you can answer this, but has the FDA asked you to quantify the contribution to intra- versus
So thank you for taking our question.
So the other question about the <unk> do you think plagued us. This alone provides enough data to prove that you have a robust effect on intra vascular hemolysis.
Since the primary endpoint was changed in hemoglobin, and then Relatedly and not sure. If you can answer the but has the FDA asking you to quantify the contribution to intra versus extra vascular hemolysis debt text. The fact of planned brink's.
Timur Ivanovic: Extravascular Homolysis that Taxotactile Plants bring. Thank you so much for those questions and nice to meet you too.
Thank you so much for those questions and nice to nice to hear you.
Cedric Francois: Thank you so much for those questions, and it's nice to hear you. So we are not commenting on the regulatory process at this point in time since we are only two weeks away from PDUFA, but Pegasus as a study has been and is the only study included in this filing, which went through a proper pre-MDA meeting and the proper evaluation. Therefore, the data contained in the Pegasus study is deemed sufficient to evaluate the efficacy of Bixi-Tacoclanin-PNH.
So we are we are not commenting on the regulatory process at this point in time again since we are only two weeks away from <unk>, but.
So I guess just as a study.
Has been on is the only study included in this filing which went through April for pre NDA meeting and the appropriate.
The evaluations. So the data contains the biggest the study is deemed sufficient to evaluate the efficacy of the makes it difficult on <unk>.
Okay. Thank you very much.
Cedric Francois: Thank you. Yeah, thank you. Thank you. Our next question comes from the line of Justin Kim with Oppenheimer. Your line is open. Hi, good afternoon, and thanks for taking the question. You may have touched on this a little bit, but with ARVO approaching near term, can you just discuss a little bit about how these tools and findings may influence your thinking on the potential commercial use of pegcetacopalin and maybe even help enhance the development approach for now?
Yes. Thank you.
Thank you.
Our next question comes from the line of Justin Kim with Oppenheimer. Your line is open.
Hi, good afternoon, and thanks for taking the question.
Maybe you touched on this a little bit, but with ARVO approaching near term can you just discuss a little bit about how these tools on the findings.
May influence your thinking on potential for commercial use the exit of Copeland and maybe even help enhance the development approach for the next generation compounds on Andy.
Justin Alexander Kim: and Approach for Next Generation Compounds and AMD
Justin Alexander Kim: Thank you, Justin. That is an excellent question.
Thank you just and that is an excellent question. So this is work that we are really very excited about them. I mean, we had you know we have a lot of that coming up at the ARVO as you know the specifically the work around the artificial intelligence is very important.
Cedric Francois: So this is work that we're really very excited about. I mean, we have a lot of aspects coming up at ARVO, as you know, but specifically the work around artificial intelligence is very important. And I think ultimately, you know, in a long-range planning context, being able to predict for a patient what the natural rate of progression of GA is going to be and what a patient and a physician could reasonably expect the drug to do, obviously sets up an interesting framework for, you know, future pricing strategies. Adam, I'm going to hand it over to you, if you want to comment beyond that. Transcribed by https://otter.ai. Thank you, Adam.
And I think ultimately in the in the long range planning context being able to predict in the patients.
The natural rate of progression of G is going to be and what a patient on a physician could reasonably expect.
The drug to do obviously sets up for.
And interesting frameworks for future pricing strategies.
Adam I'm going to hand, it over to you if you want to comment beyond that.
You said it very nicely Cedric.
Thank you you have the and I think this is this is really something that we're very excited about I think.
Adam J. Townsend: And I think, yeah, this is really something that we're very excited about. I think another piece to bear in mind here is that if you tell a patient with geographic atrophy, we are going to give them, for example, a monthly injection of Pexitacopan intraradially. I'm sure that in the first year, there will be good compliance, but at some point, you know, when you forget to have an injection or you're on holiday, you won't see a difference. So to be able to retain these patients in the long run and being able to, hopefully, give them a good treatment for the long run, is going to require something like this.
Another piece of the bear in mind here is debt.
If you tell the patient with geographic atrophy, we are going to give you for example, the most of the injection with fixed at the coupon into of this really.
I'm sure that in the first year, there will be good complaints, but at some point when you forget to have an injection of your on holiday you won't see of difference so to be able to retain these patients in the long run and being able to hopefully give them. The good treatments for the long run it's going to require something like this.
Got it alright, great great.
Justin Alexander Kim: Great. And maybe just one question. On the Phase 3 MPGN C3G program, can you just discuss with us what steps remain, if any, before initiating the study, whether there's any sort of interaction with regulatory agencies, etc., required? Thank you for that question as well. As you know, this is, of course, a trial that requires close interaction and collaboration with our partner, SOBE, but the guidance on the start of Phase 3 has not changed. It will start in the second half of this year, and we are excited to explore systemic pixie tackle in those conditions.
And maybe just one question on the phase III <unk> III program can you just discussed the that's what steps remain if any before initiating the study whether there is any sort of interaction with regulatory agencies et cetera required.
Yes. Thank you for the question as well so as you know this is of course of the trial that requires close interaction and collaboration with our partner sobey, but the guidance on the start of the phase III has not changed the two will start in the second half of this year and we are excited to explore system fix of tecogen in the.
The conditions.
Justin Alexander Kim: Great. Thanks very much. Thank you, Justin. Thank you. Our next question comes from the line of Matthew Lucini with BMO Capital Markets. Your line is now open. Good afternoon. So, I think one for me would be, just in the context, this is probably for Adam, of geographic atrophy patient segmentation, I'd just be curious...
Great. Thanks very much.
Can you just.
Thank you. Our next question comes from the line of Matthew <unk> with BMO capital markets.
Your line is now open.
Thank you good afternoon.
So I think one for me would be just.
In the context, probably for Adam on the complex the geographic atrophy of patient segmentation.
Matthew Lucini: I'd be curious if you could talk a little bit about physician levels of enthusiasm for treating earlier stage patients, those with Mason's disease. I'm thinking, you know, in
Cash if you could talk a little bit about physician level of enthusiasm.
For trading.
Earlier stage portion of the status with the nascent continues I'm thinking on the.
Complex of the EU rat and the data from last year.
Thank you so much meant to Adam do you want to take that.
Matthew Lucini: You know, in the context of the EU retina data from last year. Thank you so much, Madhu. Adam, do you want to take this? Yes, thank you.
Yeah. Thank you yeah based on the on the segmentation that we discussed we actually find that.
We use we use of in total transparency of all day to use the filling in the data.
Adam J. Townsend: Based on the segmentation that we discussed, we actually found that, and again, in total transparency, our data used Philly data when we did our market research, and we're obviously updating that. We found that actually there was a strong motivation driven often by the patient and supported by the retina specialists for earlier use than we perhaps even anticipated. Again, if you look at our segmentation and you look at the lesion size being small and non-central, and you look at the central and small lesion size, you find that physicians are motivated based on what we've seen in Philly, and I think they'll be even more motivated based on what we see in everything else that we're publishing at the moment, that there was a good groundswell for wanting to use the treatment earlier. Again, we're excited to see the data towards the end of the year. It will be a good opportunity for us to help meet some unmet needs in Georgia.
When we did on market recession, but obviously updating that we found that actually that was a strong motivation driven often by the patient and supported by the retinal specialists for <unk>.
Earlier, you said, perhaps even anticipated so again, if you look at.
Segmentation and you look at the lesion size being small and on central.
And you look at the central consolidation sides, you find that the physicians that motivated based on what we've seen in Philly and I think there'll be even more motivated based on what we see and everything else that we're publishing at the moment.
Debt.
That was a good groundswell for wanting to use the treatment earlier. So again, we're excited to see the data towards the end of the year.
So a good good opportunity for us the helped meet unmet needs in <unk>.
Alright.
On one a little bit kind of its hard to answer at this point, but you know.
Matthew Lucini: Great, thanks. And the second one, a little bit, perhaps hard to answer at this point, but...
Assuming that geographic atrophy of successful tasteful compound with the person.
Presumably a fairly large part b drug.
Matthew Lucini: But, you know, assuming that geographic access is successful, the pipeline would be, you know, presumably a fairly large part of it.
Yes, the carrying extra.
To get your thinking around sort of your approach to.
Price Youre, just your views on the evolving pricing dynamics coming out of Washington.
Matthew Lucini: I would just be curious to hear your thinking around.
Since <unk> in particular and VEGF drugs.
Matthew Lucini: that you're thinking around sort of your approach to
Adam J. Townsend: Price, your just your views on the evolving pricing dynamics coming out of Washington.
Tend to be particularly sensitive from a clinical per sector.
Adam J. Townsend: Adam, do you want to take that? Thank you. Absolutely. So, yeah, we expect about 95% of OGA to be Medicare. We've done our initial pricing work and our value discussions, obviously, based again on what we're seeing coming out of Philadelphia. I mean, it's super, super early for us.
Do you want to say thank you absolutely. So yes, so you're right we expect about 95%.
Oh Gee ATB Medicare.
We've done our initial pricing work in a value of discussions obviously based again on what we're seeing coming out of the Philly and.
I mean, it's Super Super early for US. So one thing I will say that we have seen is that people naturally gravitate when you speak to payers physicians and X pass.
Matthew Lucini: So one thing I will say that we have seen is that people naturally gravitate when you speak to payers, physicians, and expats outside of the US; they naturally gravitate towards Lucentis and Nylea as their first initial gut when it comes to pricing benchmarks for us to anchor on. Again, we have the same rationale as we have within P&H. We want to prioritize patient access. If our drug is as good as we hope it can be, then we want to make sure that patients have access to it. And we'll make sure that we talk about the value of treating GA patients. So definitely more to come, but you're spot on with your analysis of access.
Outside of the U S. They naturally gravitate towards Lucentis and Eylea as that first the initial got when it comes to pricing benchmarks for us to anchor on again, we have the same.
Rationale as we have within the <unk>, we wanted to prioritize patient access.
If our drug is as good as we hope it can be and we want to make sure. The patients have access to that and we'll make sure that we will talk about the value of treating Gi patients so definitely more to come but you're spot on with your analysis of the.
Joseph Stringer: All right. Thank you very much. Thank you, Matthew. Thank you. Our next question comes from the line of Joseph Stringer with Needham & Company. Your line is now open.
The access market.
Alright, Thank you very much.
Thank you Matthew.
Thank you. Our next question comes from the line of Joseph Stringer with Needham <unk> Company. Your line is now open.
Thanks for taking our questions I'll try another one on the.
Joseph Stringer: Thanks for taking our questions. I'll try another one on a potential P&H label. Maybe help us understand what a most favorable scenario would be and maybe a least favorable type of label would be, and I guess if you can sort of speak on that, on the details of that, maybe help us understand or put it into context those two scenarios in terms of, you know, potential number of patients or, you know, the difference, how big the gap is between those two types of scenarios. Thank you. Yeah, thank you so much, Joe. Again, we're not commenting on the label at this point in time since we are only two weeks away from PDUFA. Okay, I'll be very happy to speak about that.
Central UNH label.
Help us understand the.
One of the most favorable scenario would be.
And maybe I'll do the favorable type of label of being I guess, if you can sort of speak on debt.
On the on the details of that maybe help us understand or put it into context.
It was in terms of a potential.
Potential number of of patients or the.
The difference how big the GAAP is between those two types of types of scenarios.
For you.
Yeah. Thank you so much true again, we're not commenting on the label at this point in time since we are only two weeks away from producer.
Okay fair enough very happy very happy to speak about that.
Joseph Stringer: Okay, fair enough. Thanks for taking our questions.
Okay fair enough. Thanks for taking our question.
Colleen Margaret Kusy: Thank you. Our next question comes from the line of Colleen Kusy with Baird. Your line is now open. Hi, thanks so much for taking the question this afternoon. Starting with P&H, Adam, could you comment on how early education is going for the sub-Q administration?
Yes.
Thank you. Our next question comes from the line of Choline Kluski with Baird. Your line is now open.
Hi, Thanks, so much for taking the question afternoon.
Starting with <unk>.
Adam could you comment on how the early education going for the sub Q administration kind of any feedback you're getting on ease of use and how much education do you think patients one of them.
Colleen Margaret Kusy: Any feedback you're getting on ease of use and how much education you think...
Colleen Margaret Kusy: and how much education you think patients will need following approval.
Following approval.
Adam J. Townsend: Yep. Thank you, Colleen. Great question.
Yeah. Thank you calling great question so.
Adam J. Townsend: So, we're obviously going to make sure that we launch with a very robust patient services model. And we've been interacting with P&H patients for the last couple of months to make sure that we understand their needs when it comes to that support and patient service approach So, as I said, we will have a good footprint to make sure that we can educate people about the unmet need for P&H treatment and also any support that they might need with administration through our appellate care educators, as we call them, who will be there to help the P&H patients.
We obviously got to make sure that we launched with a very robust patient services model and we've been interacting with the pnas.
<unk> patients for the <unk>.
Last couple of months to make sure that we understand their needs when it comes to that support and patient service approach. So.
As I said, we will have a good footprint to make sure that we can educate people about the unmet need about P. N H treatment and also any support that they might need with administration true.
The palace cap educators as we call them that will be there to help the pn H patients. One thing we found is that.
Adam J. Townsend: One thing we found is that actually, patients have responded very well to the ability to have treatment at home, and the COVID scenario has amplified that. We found some great methods where we believe that, again, through face-to-face interactions where allowed, but also virtual interactions, we can support patients incredibly well with their administration. And we're very much looking forward to doing so.
Actually patients have responded very well to the ability to have treatment at home and the COVID-19 scenario is amplified that.
We found some great methods, where we believe the again through face to face interactions where allowed but also virtual interactions that we can support patients incredibly well with her administration.
And we're very much looking forward to doing so.
Colleen Margaret Kusy: Great, thanks. And then on Derby Oaks, just procedurally, will all of those patients remain randomized and blinded to 24 months, or will the study be unblinded at the 12-month readout? Just thinking about how the recent Phase 1b data continue to strengthen up to 24 months, I'm just wondering if we'll be able to see that play out in the Phase 3 data. Thank you, Colleen. Patients will stay randomized. Fede, I don't know if you want to add something to that. Yeah, no, that is the simple answer.
Great. Thanks, and then on Derby and Oaks, just procedurally, we'll all of those patients remain randomized and blinded out to 24 months or will the study the unblinded at the 12 months readout just thinking about how the recent phase one data continue to strengthen up to 24 months I'm just wondering if you can.
Some of that play out in the phase three data.
Thank you Bill ambitions, who will stay randomized.
Fit in I don't know, if you want to add something to them.
Yes that is.
So I think the simple answer so at the study will continue to be double mask on the patients will continue on the randomized schedule all the way to 24 months.
Great. Thanks.
Thank you our net.
Question comes from the line of Laura Chico with Wedbush Securities. Your line is now open.
Federico Grossi: So the study will continue to be double-masked, and the patients will continue on that randomized schedule all the way to 24 months. Great, thank you. Thank you. Our next question comes from the line of Laura Chico with Wedbush Securities. Your line is now open.
Thanks, very much for taking the question out of myself of the commentary around launch prep was actually pretty helpful and sorry, if I missed the but I'm. Just curious what is the size of the expanded access program at present and what proportion of those patients are within the U S.
Laura Kathryn Chico: Thanks very much for taking the question. Adam, I thought the commentary around launch prep was very helpful.
Okay.
Thanks, Laura for the question of I'll actually I'll hand, the expanded access program over to Dr. Federico groceries.
Yeah.
Well, we opened our expanded access program in the U S for now to help the patients with high unmet medical need to receive effects of the Gulf of them while the.
Laura Kathryn Chico: Adam, I thought that the commentary around launch prep was actually pretty helpful, and I'm sorry if I missed this, but I'm just curious, what is the size of the expanded access program at present, and what proportion of those patients are within the U.S.? Thanks, Laura, for the question. I'll actually hand the expanded access program over to Dr. Federico Grossi.
On the drug is or the application of screen review by the FDA, We don't expect the EAP program true affect our commercial.
The metrics.
When you're in the.
At least close to plateau for we're not commenting on the Florida.
On the X program.
Okay. That's helpful.
Maybe one other question then I think.
Federico Grossi: Well, we opened our Expanded Access Program in the U.S. for now to help patients with time and medical need to receive Paxilta Copeland while...
The latest 10-Q continues to point towards cash runway into the second half of 'twenty two.
I'm just wondering if you could elaborate a little bit more on the levers there that could either contract or extend that runway of bit.
Federico Grossi: We don't expect the EAP program to affect our commercial metrics or revenue. And this close to Padufa, we're not commenting any further on our early access program.
Against the backdrop of Derby and Oaks, the primary end point reading out in the third quarter of 21. The studies do run for two years or so so in the <unk> of 'twenty. Two so just trying to understand how the spend in the studies might change after that primary readout or how do we should be thinking about that thanks.
Laura Kathryn Chico: Okay, that's helpful. Maybe one other question then. I think the latest 10-Q continues to point towards cash runway into the second half of 22. I'm just wondering if you could elaborate a little bit more on the levers there that could either contract or extend that runway a bit, and just against the backdrop of Derby and Oakes, the primary
Thank you Laura Tim do you want the pig that.
Sure. Thanks, Laura Yeah, that's of Great question, because actually that debt calculation around cash runway contemplates the G. A success scenario wherein we built the.
Laura Kathryn Chico: Reading out the third quarter of 21. The studies do run for two years or so, so in the 3Q of 22. So just trying to understand how the spend in the studies might change after that primary readout or how we should be thinking about that.
Global launch capabilities and also move forward in other studies related to <unk>.
Thanks, you the comp when <unk> really so ultimately.
Timothy E. Sullivan: Thanks. Thank you, Laura. Tim, do you want to take this?
The calculation becomes very different of G. A were not to be successful and we were not to move forward on our cash runway would get extended quite a bit beyond that.
Timothy E. Sullivan: Thanks Laura. That's a great question because actually, that calculation around cash runway contemplates a GA success scenario wherein we build up our global launch capabilities and also move forward in other studies related to [inaudible] You know, how we perform in terms of our commercial launch in P&H, pretty much. I hope that answers your question.
Aside from that you know.
For the typical things relate to.
You know.
How we perform on the.
Terms of of our.
The commercial launch of peonage pretty much so.
Hope that answers your question.
Laura Kathryn Chico: Thank you so much, Laura.
Thanks, guys.
Thank you so much of our App.
Cedric Francois: Well, thank you all for joining us on our first quarter conference call. We look forward to our May 14th PIDUFA date in P&H, and we are excited about the transformational year ahead for Appelis as we continue to build our global leadership and complement.
Well. Thank you all for joining us on our first quarter conference call. We look forward to our of May 14th we do for it and peonage it'd be very excited about the transformational year ahead for our business as we continue to build our global leadership income to them. Thank you again, so much for you on yesterday.
Operator: Thank you again so much for joining us. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Operator: ["Pomp and Circumstance"] ["Pomp and Circumstance"]
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