Q4 2024 Precigen Inc Earnings Call
Speaker Change: Good evening and welcome to the Precigen's full year 2024 financial results and business update call. At this time, all lines are in listen only mode.
Speaker Change: Following the prepared remarks, there will be a question and answer session.
Please note that this event is being recorded.
Speaker Change: I would now like to turn the conference over to Steve Harasym from Investor Relations. Please
Steve Harasym: Thank you, Allen, and thank you for everyone joining us this afternoon. With me today, our Dr. Helen Sabzevari, President and CEO of Precigen, Harry Thomasian, our CFO , Phil Tennant, our Chief Commercial Officer, and Retool Shaw, our Chief Operating Officer.
Before we begin, let me briefly review our former looking statements.
Steve Harasym: During today's call, we will make various forward-looking statements. Investors are cautioned that our forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ from those indicated by our forward-looking statements.
Steve Harasym: Please read the Safe Hauer statement contained in our most recent SEC filings as well as risk factors contained in Precigen's filings.
Speaker Change: With that, I would like to now turn the call over Dr. Sabzevari.
Helen: Thank you, Steve, and thank you to all for taking the time to join us for our year and 2024 update.
Helen: It is indeed a transformative plan for at the Precigen and as we are on the verge of commercializing our lead asset PRGN 2012 in RRP, potentially bringing a treatment to this patient population with a high on meth needs.
from Discovery in 2020.
Phase I initiation in 2021 in 2021.
Helen: Phase 2 with Breakthrough Designation and Accelerated Approval Pathway in 2023, followed by publication in Science translation and presentation of the groundbreaking data at ASCO in 2024.
Helen: This finished 2024 with submissions of our BLA and announced FDA's acceptance with priority review with an upcoming Precifer date of August 27, 2025.
Helen: The FDA has indicated that there are not currently planning to hold an advisory committee meeting
Helen: I would like to now take a few minutes to recap of our data which actually recently has come out in Lancet publication.
Helen: We are extremely excited about PRG in 2012, potential in RRP, to not only be the first but the best in the class treatment
Helen: Due to significant effect in terms of efficacy, safety, the ease of root of administrations.
in our pivotal clinical data.
Piorgian 2012 demonstrated a statistically significant efficacy.
Helen: I want to emphasize that our clinical study was designed with a robust
Helen: Clinically meaningful and most importantly, a prospectively defined a statistical primary efficacy and points of complete responses in RRP patients.
[inaudible]
Helen: Complete responses have been durable with medium durability of response at 24 months.
Helen: and all of our phase one complete responders remain surgery free and incomplete response three years.
Helen: This is highly significant and I'm going to stress that the data that was presented at ASCO showing collectively phase 1 and phase 2, it has such a close.
Helen: repeats that in our phase one we had 50% complete responders and phase two 52% for the average of 51% complete response in a prospective manner.
Helen: Furthermore, 86% of all of our patients had reduction in the number of soldiers.
Helen: That's shown it can be repeatedly dose not only in our current program a P O Jan 2012, which has been four doses, but also in all the other programs such as P. O Jan 2009, which has been done.
Helen: More than 20 times.
Helen: These platform is different than either a lease or other viral platform that they have a limited amount of time that you can dose dump sciences, once and twice gorilla adenovirus it can be repeat dose.
Helen: And continues to lead to the enhancement of the T cells and the absence of neutralizing antibody significant and neutralizing antibodies.
Helen: And finally, I would like to say that the appeals in 2012 based on all the data that has been shown under follow up.
Helen: It's extremely well tolerated with no dose limiting toxicity no treatment related adverse events greater than like too.
Helen: And as we have already shown the route of administration is just a simple sub Q administration that can be given that any of it.
Helen: Well, we also have continued with our readiness to hit the ground running post to do Friday.
Helen: In August of 2025, as we shift from R&D to commercialization and the sale of commercial would be speaking to that.
Helen: Finally, I would say a few words about our confirmatory trial, which already has been initiated and has started enrolling patients.
Helen: Our confirmatory trials in alignment with the F. D. A is a single arm no placebo control required.
Helen: 35 patients to be enrolled and we are well on our way not only we have started enrolling patients but to move very rapidly and finishing this thought so.
Tool Shah: So with that I will now turn the call to her tool Shah, our chief Operation Officer, which will be speaking to our CMC and manufacturing readiness.
Tool Shah: Thank you Helen I would like to take a few moments to discuss our manufacturing strategy and for women.
Tool Shah: As you are aware, we have made significant commitment and investment to be in control of our GMP manufacturing activities with that strategic goal in mind, we hadn't built an in house dedicated GMP facility, but are adding almost jumps up since manufacturing back in 2019.
Tool Shah: Again manufactured all peers in 2012 drug substance lots utilized in our clinical trials that this facility now we have upgraded the facility and with a strong leadership and operations team. We are ready to support the commercial launch of Gen. 2012. In addition, we utilized an established commercial.
Tool Shah: C D L O for the fill and finish operations for the Pea out again in 2012 drug product.
Tool Shah: We have also built significant G M P quality control capabilities in house to support release testing of Pier G. In 2012, together, a GMP manufacturing and testing strategy is designed to give us better control over more specialized operations overall timelines and provide independence.
Tool Shah: From external vendors as much as practical while containing costs.
Tool Shah: As part of the June 2012, we had completed the process validation as previously aligned with the FDA. We are confident in our ability to supply P. O G. In 2012 product to meet anticipated demand at launch and beyond.
Speaker Change: With that I'd like to now hand over to full talent, our chief commercial officer to provide update on pier G. In 2000, and total market opportunity and our commercialization strategy. So great. Thank you Richard good afternoon, everyone.
Past few months have been incredibly dynamic for a commercialization team as we advance preparations for the commercial launch around the August 27th producer and as Helen said. This is a pivotal milestone for us as an organization and I am excited to share the progress that we've made since our last update so we've made some significant strides in our launch.
Speaker Change: Readiness, including several major accomplishments firstly, we've completed the build out of our prestige and commercial leadership team, we have very strong and experienced team now across sales marketing medical affairs and market access and distribution, who have the experience and the capabilities to guide the launch with precision.
Speaker Change: And impact.
Speaker Change: Secondly, we've established a comprehensive commercialization strategy for the U S launch in this spans all facets of our operations to ensure we hit the ground running at launch.
Speaker Change: And then in terms of a broader commercial infrastructure, we are delighted to announce our partnership with <unk> to implement the U S launch is.
Speaker Change: As a proven leader in supporting rare disease launches.
Speaker Change: Sound It brings a wealth of experience that complements our vision for P. O G. In 2012 together, we are executing on critical launch activities across the spectrum.
Speaker Change: <unk> the training and deployment of dedicated field teams to ensure seamless and impactful launch.
Speaker Change: Our updated analytics underscore the importance of this work our advanced analysis has shed at J P. Morgan. It suggests that up to 27000 adult patients in the U S. A living with a P which is higher than the previous estimates of up to 20000 and indicative of an even greater unmet need.
Speaker Change: These data strengthen our resolve to launch P. O G. In 2012 with a patient centric focus ensuring timely access to this transformative treatment. So in summary, we're moving decisively towards launch driven by an experienced leadership team.
Speaker Change: Really capable commercialization partner and a robust strategy.
Speaker Change: These elements position us well to realize the full potential of P. O G. In 2012 with commercial revenues expected to begin in the second half of 2025, we are trying to hit the ground running given our producer date.
Speaker Change: And that would clearly position us as the first and only medical treatment available for these patients.
Speaker Change: Back to you Havent, Thank you felt well.
Speaker Change: Well as you can see that on.
Speaker Change: The level of excitement among our surgeon and our teams are obviously P. O. G. N 2012 has been our highest priority and remains to be our highest priority as we take on and transform their organizations from R&D to commercial organization without them.
Speaker Change: Mind, However, I would like to also give you an update on two other program that has been very exciting and very important the fair.
Speaker Change: First one is our pier G. In 2009, which is our go realize in a virus strong product that targets HPV 16, and 18, which is the lead cause of HPV related cancers will have a total of 5% of all cancers at H B.
Speaker Change: Really that and that includes a recall cancers head and neck and anal cancer indications on P. O. Jan 2009 had been targeting HPV 16 18.
Speaker Change: We presented the data the phase one data at ash, so in 'twenty to 'twenty three we showed not only a very favorable.
Speaker Change: Safety and Tolerability profile, but more importantly in the relapsed refractory patients that they had failed even all the checkpoint inhibitors.
Speaker Change: We're able to show for the first time for any drug products in these settings.
Speaker Change: 30% objective responses.
Speaker Change: Complete responders as well as partial responders, we had a complete responders are standing close to two years of a response.
Speaker Change: I mean these same patients we have shown in some of them have received excess of 20 doses.
Speaker Change: Oh Pier G. In 2009, which has the exact same backbone S. P O Jan 2012, and have shown not only the neutralizing antibodies are that day.
Speaker Change: I'm not increasing at all but also.
Speaker Change: Alere enhancement of T cell responses.
Speaker Change: Upon re dosing of these patients. So this clearly these clinical data in conjunction with other neurological data points again to the differentiation of our realizing a virus platform than any other platforms and currently on P. O G. In 2009 is Atlanta.
Speaker Change: Sing.
Speaker Change: Phase two both for cervical cancer, and head and neck I N C. I and we continue to expand on that and we will be looking forward in near future to be giving updates on these two programs.
Speaker Change: At the same time.
Speaker Change: I like to give you an update on our ultra car T platform. As you are aware, our ultra car T platform to our knowledge is generally the only car T platform that can deliver autologous car T.
Speaker Change: Patients overnight at the setting of the hospital without a centralized manufacturing.
Speaker Change: These centralized manufacturing, it's overnight and it's a tall I guess it contains the car of the interest plus the safety switch, which becomes very important if anything goes wrong. You can eliminate these cells immediately at the same token with the mechanism of membrane bound IL 15.
Speaker Change: Which allows actually the persistence and the expansion of these cells in a way the manufacturing of these cells directly in vivo in patients and you do not need in vitro expansion of these cells.
Speaker Change: Last year, we communicated that we had finished all.
Speaker Change: He's one b.
Speaker Change: In AML patients.
Speaker Change: And we also communicated that that we are preparing for the presentation for the end of phase one b to F D. A.
Speaker Change: In my life J P. Morgan, we presented further data and quite exciting days out that and I believe it's the first time ever that any company.
Speaker Change: Uh huh.
Joan: Joan this.
Speaker Change: For the first time, we have developed and discovered a specific biomarkers.
Speaker Change: For the AML patients in all responders versus non responders after the treatment with the car Ts.
Speaker Change: And we have shown parts of that data at J P. Morgan and I finally encourage people to take a look at that presentation. If they have not seen that we are currently very much excited about putting this matter altogether and we are preparing for our meetings with the F D a to discuss.
Speaker Change: They are not only the platform, but also on the AML data and also to discuss the strategy for the pivotal phase two and the path for approval and starting with the AML.
Speaker Change: Please stay tuned we will be giving you updates on that level as well.
Speaker Change: And finally I would like to also mention that our ultra car T platform.
Speaker Change: Has it been generating very exciting data in the autoimmune setting and as you know the requirements for autoimmune settings.
Speaker Change: You have to have a safe cars that you can be actually generated that with the price tag that can be.
Speaker Change: Used in number of dosing and our car T platform meet all of that including with our safety switches and also the next generation.
Speaker Change: Just meant that it does not require any use of checkpoint inhibitors in them and with that data. We believe that in the field of autoimmune disease not only we have the ability to be first in the class, but also the best in the class and this is ongoing and we are very.
Speaker Change: Writing about this.
Speaker Change: So with that update I would like now to hand over to our CFO Harry sorry, Thanks, very much Alan and welcome to those participating on the call today.
Speaker Change: This really is an exciting time at precedent as we prepare for the launch of our first commercial drug product you've already heard from other members of the precedent team as to our preparedness toward this goal and I'd like to spend some time discussing our financial position as we move toward commercialization.
Speaker Change: I'll begin by highlighting our financial results for 2024.
Speaker Change: Overall, we finished the 2024 year with a net loss of $126 $2 million.47 per basic and diluted.
Speaker Change: Sure compared to a net loss of $95 9 million or <unk> 39 per basic and diluted share in.
Speaker Change: And the year ended December 31 2023.
Speaker Change: I'd like to point out that our current year net loss, including over $55 million of noncash charges net.
Speaker Change: Our cash burn for 2024, consisting of cash used in operations plus capital expenditures totaled $76 $8 million.
Speaker Change: Our press release and management's discussion and analysis included in our 10-K, both of which were just filed with the SEC provide further detail as to fluctuations in our statement of operations between 2024 and 2023.
Speaker Change: With that summary of our operating results I'd like to spend a little time focused on our financial position.
Speaker Change: As I believe most of you listening in are aware, we raised $79 million at the end of 2024, we are preferred stock issuance, which included the issuance of warrants to purchase common stock.
Speaker Change: We believe that the terms of this preferred share instrument friendly to the company.
Speaker Change: The preferred stock carries an 8% dividend of which the first two years are to be paid in time.
Speaker Change: Beginning with the third year, while dividends will be payable in cash the payment of such are due when and if declared by presages board of directors.
Speaker Change: While the preferred shares are convertible into common stock the conversion feature resets each quarter, thus, reducing the dilutive effect of a potential conversion as our stock price increases.
Speaker Change: In addition, the company has the ability to redeem the preferred shares for the stated value plus accumulated and unpaid dividends, while the holders do not have the ability to put the shares to the company.
Speaker Change: You can find more detail summary of the terms of the preferred stock issuance and the financial statements in our Form 10-K, just filed with the SEC or within.
Speaker Change: Alright tell you announcing the transaction that was filed with the SEC on December 30th 2024.
Speaker Change: On top of the funds received from the preferred stock issuance. We also monetized in a non dilutive manner certain intellectual property rights and our royalty rights related to noncore asset of the company in December 2024, which resulted in proceeds of $8 5 million.
Speaker Change: Yeah.
Speaker Change: The preferred issuance plus the aforementioned sale of intellectual property rights of royalty rights help shore up our balance sheet and we finished the year with cash cash equivalents and investments of $97 $9 million were confident that this balance will support us well beyond our anticipate.
Speaker Change: The launch date and well into 2026.
Speaker Change: This runway is based on current projections, which includes anticipated revenue from the commercialization of Pier G N 2012.
Speaker Change: As Helen mentioned earlier, our BLA was accepted by the FDA in February under a priority review with a produce the target action date set for August 27th of 2025. This target action date, plus the preparedness of our commercial team as you heard from Phil earlier.
Speaker Change: Divides me with a level of comfort to include revenue in my projections, although from an accounting perspective. This anticipated revenue is considered outside of our direct control as that revenue is dependent upon the successful FDA approval of the PRT in 2012 BLA.
Speaker Change: In closing I want to reiterate that precedent has always shown a strong financial discipline and we will continue to do so in the future. Our focus has and always will be to utilize our resources to garner the highest value for our shareholders.
Speaker Change: With that I'd like to open up the call for Q&A and turn it over to Alan the operator.
Speaker Change: Thank you.
Alan: Ladies and gentlemen, we will now begin the question and answer session.
Alan: Should you have a question. Please press star one on your Touchtone phone.
Alan: You'll hear a prompt that your hand, that's been raised.
Alan: Do you wish to decline from the polling process. Please press star two.
Alan: If you are using a speaker phone please lift the handset before pressing any keys.
Alan: Please limit your question to.
Alan: To one and one follow up then you can go back to the queue.
One moment. Please for your first question.
Speaker Change: Your first question comes from Jason Butler of citizens Youre line is already open.
Jason Butler: Hi, Thanks for taking my question and congrats on the progress.
Jason Butler: Two for me one just at a high level can you give us an update on the interactions with FDA and just how would you characterize the ongoing review for 2012 and then just on the commercial side can you speak to what your current thoughts are on the size of the field force and the number of centers that you'll be targeting.
Jason Butler: During the initial launch thank you.
Okay.
Jason Butler: Hi, Jason. Thank you for the question. So in regard to the BLA submission and actually receiving a priority review we have been having as we have mentioned throughout.
Jason Butler: There are submissions as well as even before that very very close interaction and alignment with the FDA and we are very thankful to the SBA for a close interaction in the guidance is on continues to do so we are I think are in there.
Jason Butler: Very good position in our our.
Jason Butler: Our submission of the BLA in discussions and we continue to do so.
Jason Butler: As you can imagine throughout there.
Jason Butler: A few cycles. So colorants Lee of course, we stay very close in alignment with FDA.
Jason Butler: And in regards to the commercial I think maybe Phil can address that.
Phil: Right Yeah sure there were a couple of past that so regarding the size of the field force we've been fairly consistent and I was thinking that we believe it's somewhere in the range of 15 to 20 representatives in the field and that hasn't changed in terms of what we're thinking sort of fairly modest sales team. We believe there are around 500.
Phil: Our fellowship trained otolaryngologist out there who will be responsible for treating the bulk of the patients and those will largely be concentrated in the urban academic centers and the large idms and that will be.
Phil: An important part of.
Phil: We're targeting.
Phil: Alright, Thank you very much.
Phil: Okay.
Speaker Change: Your next question comes from Ben Burnett of Stifel. Your line is already open.
Speaker Change: Hello. Good afternoon. This is catalina.
Speaker Change: So.
Speaker Change: Thank you for taking our questions and congratulations on all the.
Speaker Change: Thanks.
Speaker Change: Do you do you have any line of sight at this point on the timing for any additional meetings with the FDA pre licensing spectrum. Some labeling discussions given the review process.
Speaker Change: <unk> as well.
Speaker Change: Hi, Carolyn and thank you for the questions of course, a part of the regulatory process are there all the inspections on the Florida facilities are because of that we will not be making any comment but this is to be.
Speaker Change: Call, especially for a GMP facilities as I mentioned, we have been always in very close alignment continues to be a way that S. P. A and we look forward to further communication as the obviously, we get closer to our producer date.
Carolyn: Okay. Thank you Tom.
Carolyn: Pier G M 20 trials gets appeal.
Carolyn: Do you anticipate there would it be a bolus of patients and how do you plan to position yourself.
It.
Carolyn: Yeah, Great question I mean, we absolutely do think there's pent up demand here. These patients have known as I have no other options really are on label.
Carolyn: At all it's the only surgery and some off label treatments, which don't under don't address the underlying infection. So absolutely. We believe that there will be a concentration of patients.
Carolyn: Who are in desperate need of this type of medication when we get to market and so we will be deploying our team and our efforts accordingly to make sure that as many of those patients appropriately get our treatment as soon as possible.
Carolyn: Okay.
Speaker Change: Okay. That's good thank you very much.
Carolyn: Thank you Kyle.
Carolyn: Okay.
Carolyn: Your next question comes from so.
Pakula Ramekins: So I am pakula Ramekins of H C. Wainwright your line is already open.
Speaker Change: Thank you this is RK.
Speaker Change: From his he ran right good afternoon, Alan so.
Speaker Change: Steven.
Speaker Change:
Speaker Change: So in terms of.
Speaker Change: The indication itself.
Speaker Change: Phil you were saying that you know based on you are looking at the claims there.
Speaker Change: That number seems to be a higher than the Ars 27000 in the United States and probably around 125000 outside the U S.
Speaker Change: But.
Speaker Change: You know that is with with no therapy.
Speaker Change: No approved therapy as I said in one of their patients who are brave enough to go under the knife, so with an approved drug.
Speaker Change: How easy do things how easy is it.
Speaker Change: Four four.
Speaker Change: For patients to get diagnosed.
Speaker Change: They do have our ERP and number two.
Speaker Change: How are you thinking of trying to get those patients.
Speaker Change: Our approach to dose patients who.
Speaker Change: Now that who have not yet been diagnosed.
Speaker Change: Is there a mechanism by which you can actually get these patients diagnosed.
Speaker Change: Correctly.
Speaker Change: Yeah, Great Great. Let me take the first okay. So you know the patients are very visible.
Speaker Change: So they're having surgeries they have many of them are frequent surgeries on an annual basis. So.
Speaker Change: We believe a lot of those patients are going to be readily identifiable at launch.
Speaker Change: And obviously, that's it that's a key area for us to focus on.
Speaker Change: You know like all good launches we will have.
Speaker Change:
Speaker Change: Personal and non personal promotion, we will have remote.
Speaker Change: Promotion.
Available and so you know where we can't reach everyone.
Speaker Change: With a face to face interaction, we will be able to provide information and direct people to the appropriate information.
Speaker Change: Are there patients, but the focus is definitely on those who are already visible because we think that will be the bulk of the patients actually that are out there at the moment. The other phenomenon and I would say that we have seen in other rare diseases is when you start to get a new treatment in a rare disease area.
Speaker Change: The amount of.
Speaker Change: Diagnose patients who were presenting patients actually increases because of the enhanced awareness understanding and education health. It we've seen that in a number of them.
Speaker Change: Other rare diseases, and we don't think this will be any different.
Speaker Change: And maybe okay and this is Helen I can also add to what Phil mentioned in regard to the patient obviously identification that currently that adult patients that they have and they live with their RFP.
Speaker Change: This is a patient population that is at the target on these patients are highly themselves are involved in regard to the finding a new.
Speaker Change: <unk> innovative treatment because as you know for almost the past 50 years. This disease has been around and unfortunately, there has been no treatment for this disease, except the continuous surgery, which is just a bandaid in a sense and from that perspective.
Speaker Change: Not only their patients themselves, but also we have been obviously two a M.
Speaker Change: Whole educational system with a base Ah patient.
Speaker Change: Yeah.
Speaker Change: The groups and that for instance, we had last year. The R. R P day and.
Speaker Change: For patient awareness in our RFP awareness and Ids and basically campaigns will continue.
Speaker Change: We go through our producer and beyond and to ensure that not only all the patients are aware of the innovative treatments, but also that and investigators.
Speaker Change: Just and.
Speaker Change: The kols and they are fully familiar with their various aspects of that.
Speaker Change: Hopefully the new soon to be a standard of treatment.
Speaker Change: Upon obviously F.
Speaker Change: FTA approval.
Speaker Change: For our RFP, which is a we are thrilled.
Speaker Change: To have played a part.
Speaker Change:
Speaker Change: Display hopefully becomes approved for these patients in this century.
Speaker Change: Perfect. Thanks for all that color, but let me try another two part question.
Speaker Change: As far as the confirmatory trial is.
Speaker Change: Yeah.
Speaker Change: Four of the Pier G in 2012, and what's the current status and also do you think you'll.
Speaker Change: You will be Oh.
Speaker Change: Will be close to completion by the time, you get to the proof of it.
Speaker Change: And then the second part of.
Speaker Change: The second question actually is on the Piaggio and 3006.
Speaker Change: Should we expect any of that data from the phase one study to be published.
Speaker Change: Either in the first half hour later in.
Speaker Change: In the year.
Speaker Change: Right great great questions in regards to the confirmatory for P. R. J in 2012 as mentioned is a part of the BLA submission is that you have initiated the trial already and we did that last year actually are well ahead of the.
Speaker Change: Submission of the BLA and are currently the patients not only they are in.
Speaker Change: Being enrolled.
Speaker Change: Yeah.
Speaker Change: Finishing end date for the confirmatory trial.
Speaker Change: No our endpoints the confirmatory trial design, which again in full alignment and a very close eye agreements with the F. D. A S. P. A has given us the exact same design as we had for our pivotal which was basically.
That single arm trial, 35 patients no placebo requirement.
Speaker Change: For the lab as a second basically Oh arm.
Speaker Change: And it's a complete response says which takes 12 months minimum of 12 months as I mentioned, we currently have been following of course our patients.
Speaker Change: In a prospective manner well over 12 months and the median is about 24 months and a phase one patients which are the oldest patient that they have been obviously dose.
Speaker Change: They have now all of those complete responders are still in a complete response three years later, so by that definition of the complete response end point, we will not be having the days out by close to <unk> five day.
Speaker Change: We anticipate that of course in 'twenty 'twenty six 'twenty 'twenty seven.
Speaker Change: We won't be reporting on those data so but as you can imagine there is a high level of excitement from the patients.
Speaker Change: For this trial, especially in view of this safety.
Speaker Change: That we have shown the efficacy that we have shown the ease of administration. The route of administration, which is the sub Q like you are getting their flu shot basically and the obviously the durability of the response that is being seen by the patient. So I think there's.
Speaker Change: Further has the added to the enthusiasm of the patients and investigators and also really the physicians for this.
Speaker Change: Right.
Speaker Change: Okay.
Speaker Change: And thank you and yeah, and then in regard to my apology for hooked up to the ultra car on AML and.
Speaker Change: We will be having the discussions with the FDA, we will be giving an update on <unk> and also we are looking at the proper value to them and show that data and we will be and translating those information and then the San Francisco.
Speaker Change: Thank you. Thank you thanks for all that.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Your next question comes from Jennifer Kim of Cantor. Your line is already open.
Jennifer Kim: Hi, Thanks for taking my questions maybe to start off to follow up on one of the previous questions.
Speaker Change: I just wanted to clarify will the FDA is manufacturing facility inspection come ahead of the mid cycle review and I assume that's happening in late May but do you think you'll have a sense by the mid cycle review, how that gains thinking maybe I can start there.
Speaker Change: Thank you Jennifer hurdle here I think.
Speaker Change: Yes, we do anticipate a preapproval inspection OPI and before the approval, but it's as Helen mentioned in response to the prior question that is part of the regulatory process.
Speaker Change: Not able to comment on the timing at this point, but as we mentioned, we look forward to hosting them and we anticipate.
Speaker Change: That inspection.
Speaker Change: Before the approval.
Speaker Change: Okay, and maybe a question for Phil.
Speaker Change: 500 doctors that you're initially targeting.
Speaker Change: What percent of market does that capture and could you give some color on how the internal sales forces coordinating with me ever sign a partnership.
Speaker Change: Right, Yeah, I mean, those 500 TNT that I mentioned, I mean, they'll be responsible for the vast majority of the patients that we believe are out there they're always obviously a community presence as well for patients. So there. So that's something that we're not ignoring but I can't we feel that the concentration is in the urban incentives.
Speaker Change: And that's how we'll be.
Speaker Change: Thinking about our field force deployment to a large extent.
All the field teams are episodic.
Speaker Change: So we are not having any presage and employees that are in the field as such they will all be through Arizona, but obviously, they will act like precedent employees through that strong partnership with China.
Speaker Change: Okay.
Speaker Change: Okay do you have an important increase right.
Speaker Change: Sorry, Jennifer.
Speaker Change: The thing I'd point to stress I did mentioned it in my prepared notes was that their dedicated to <unk> in 2012.
Speaker Change: Okay.
Speaker Change: Okay. That's helpful. If I could squeeze one more question for Phil in your discussions with payers is the expectation still that Ah I guess the.
Speaker Change: Access to this treatment if approved would depend mostly on untreated the trial criteria in my book versus a medical exception or have those discussion default.
Speaker Change: Yeah, we continue to support its great question, we continue to speak to many payers, we've actually spoken to payers that represent collectively over 300 million lives.
Speaker Change: In the U S and we're getting a consistent response.
Speaker Change: You know that the price range that we'd be talking with them about that.
Speaker Change: We're likely to see a.
Speaker Change: Some degree of utilization management some prior authorizations, we hope that that is.
Speaker Change: To label.
That's what we are trying to achieve but there are some payers, who would who would actually include inclusion and exclusion criteria, we feel we feel that.
Speaker Change: We have a strong case, we're building a strong value proposition to make sure that in either of those scenarios. We were in a great position medical exception.
Speaker Change: Is really the last resort in terms of where we think some of these payers will go based upon the discussions that we have so.
We are preparing ourselves with a strong value proposition to complement the clinical value proposition that we have and I think Jennifer it's from their perspective.
Speaker Change: Obviously.
Speaker Change: That this would be for all RFP patience and there as.
Speaker Change: Our recent data have shown.
When these patients even receive them when they have received up to five surgeries.
Speaker Change: And the damage to the vocal cords and tracheal it becomes irreversible. So you can imagine that it becomes very important.
Speaker Change: In a setting that they treat their patients prior to getting to this level and obviously the payers also recognize that and then basically the effect of the surgery on patients that are on their life on the irreversible Dom.
Speaker Change: But also on the losses that occur as a result of all of that and I think this is one of the very important part of.
The recognition by the payers.
Speaker Change: Okay. That's helpful. Thanks, guys.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Your next question comes from Brian Cheng of Jpmorgan. Your line is already open.
Brian Cheng: Yes, thanks for taking our questions. This afternoon.
Speaker Change: And then just as far as.
Brian Cheng: Can you give us an update on the latest on where you are.
Speaker Change: In preparing.
Brian Cheng: Besides to administer 2012.
Brian Cheng: And could you talk about there there are 500 initial adopters.
Brian Cheng: Can you talk about how you know the initial 500 doctors overlap lifestyles initial sites are ready to go to administer 2012.
Brian Cheng: And then we have a follow up thank you.
Brian Cheng: Thanks, Brian.
Speaker Change: I mean, there's nothing overly complex about administering the drug at the site or special preparation that really need we know we have cold chain requirement, but we know where for subcutaneous injections.
Speaker Change: Nothing in the research that we've done in the sites that we're speaking to suggest that there's anything in terms of special preparation that is required.
Speaker Change: Other than that to think about it so.
Speaker Change: We at the academic institutions are large idms, they're well equipped where obviously understanding exactly what that last 100 yards for the drug journey looks like.
Speaker Change: Speaking to them regarding that so that basically we deliver a seamless distribution.
Speaker Change: Service as possible from from ordering the drug to the patient and that's been the focus and there's nothing particularly complex a special that we need to call out in terms of preparation.
Speaker Change: Okay, and then maybe just one on.
We are.
Speaker Change: It's on pricing and payer access.
Speaker Change: Maybe just wanted to ask.
Speaker Change: What's your latest take on pricing for 2012, and then just on the pricing standpoint.
Speaker Change: Can you talk about how we should think about I'll pause here and you know when it comes to <unk>.
Speaker Change: I agree.
Speaker Change: 10 years, do you, saying that a value based agreements or <unk>.
Speaker Change: I'll be expected here.
Any initial thoughts just based on your ongoing engagement with payers will be very helpful.
Speaker Change: Yeah sure as I said earlier I mean, we've we continue to speak to payers and we continue to get it.
Speaker Change: Fairly consistent response in terms of the value proposition, the economic and clinical that we were making.
Speaker Change: So nothing's really changed in that regard value.
Speaker Change: Value based pricing I mean, I know it's out there it's something that's being considered the payers tend to have a view that it's attractive in theory difficult in practice, sometimes so.
Speaker Change: We're exploring that a little bit more but again, we believe.
Speaker Change: The price point in a way that will bring this value to the market is going to be relatively straightforward and something that is.
Speaker Change: Within the wheelhouse of these institutions.
Speaker Change: I haven't seen before and.
Brian Cheng: And also Brian maybe I cannot just to sell it.
Speaker Change: Obviously, we have communicated before this is a rare disease.
Speaker Change: With no it's under adult care and for the past Hum.
Speaker Change: For pulp century to be honest.
Speaker Change: And payers recognize that and they recognize also the losses to these individuals not only the financial but the emotional and also from a life perspective, and then on top of that and one of the things that it becomes a.
Speaker Change: Very very important and these are the payers appreciate that and then discussions that we have had is very clear that safety and that the strike there.
Speaker Change: They'll reverse there.
Speaker Change: Efficacy, which is unseen prior by any treatment.
Speaker Change: 51% complete responders and as I mentioned today on the update that actually for the for the first time, we have now the media notwithstanding a 24 month, but also our phase one all the complete responders pharma phase one study that we started in 2021.
Speaker Change: And are they all of them are.
Speaker Change: It's still in a complete response and this is another important part of the discussions.
Speaker Change: Pay yes, I very much appreciate evolves and we got to the efficacy durability of response and the ease of administration and also the effect that it has not only on a stopping the disease for a majority of these patients as they complete.
Speaker Change: Responders on reducing the requirement for surgeries and 86% of the patients but also from the fact that once they get in it and the earlier that they they get in with our Pier G. In 2012, it can really.
Speaker Change: In fact and reverse the situation not to get to the situation that now there is an irreversible damage to their local courts or the trachea of these patients and as a result of that there is a permanent and lifetime damage and I think that's another extremely important value out there.
That they do pay attention to.
Speaker Change: Great. Thank you so much for taking my questions.
Speaker Change: Thank you.
Speaker Change: There are no further questions at this time.
Speaker Change: I would hand over the call to a doctor Helen subsidiary for closing remarks. Please go ahead.
Speaker Change: Thank you.
Speaker Change: As we move one step closer to commercialization I want to take this opportunity to thank our team at Crestwood Chang.
Speaker Change: For their tireless work and steadfast dedication to bringing PR Jan 2012 to market.
Speaker Change: Our team understands that patients with RP are burdened significantly by this disease and that with surgery. There are innumerable risks to their health and for long term irreversible injury. Our team is.
Speaker Change: Actually im acutely focused on delivering the first and only FDA approved therapy to their RFP community as quickly as possible with that I wish you all a very good evening and thank you for participating in our call.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and you may now disconnect.
Speaker Change: [noise].
Speaker Change: Yeah.