Q1 2024 bluebird bio Inc Earnings Call

Operator: Thank you for standing by, and welcome to the Bluebird Bio first quarter 2024 results call. All lines have been placed into a listen-only mode. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star followed by the number one on your telephone keypad. If you would like to withdraw your question, press the star one again. Finally, you are reminded that this conference is being recorded. I would like to turn the call over to Courtney O'Leary from Investor Relations. Please go ahead.

Thank you for standing by and welcome to the Bluebird Bio first quarter 2024 results call all lines have been placed into listen only mode.

After the Speakers' remarks, there will be a question and answer session.

If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad.

I would like to withdraw your question press the star one again.

Finally get reminded that this conference is being recorded.

Like to turn the call over to corneal theory from Investor Relations. Please go ahead.

Courtney O'leary: Good morning, everyone, and thank you for joining our first quarter 2024 results call today. My name is Courtney O'Leary, Director of Investor Relations at Bluebird Bio.

Courtney O'leary: Good morning, everyone and thank you for joining our first quarter 2024 results call. Today. My name is Courtney O'leary director of Investor Relations at Bluebird bio.

Courtney O'leary: Before we begin, let me review our safe harbor statement. Today's discussion contains statements that are forward-looking under the Private Securities Litigation Reform Act of 1995, including expectations regarding our future financial results and financial position. In addition to statements of the company's plans, expectations, or intentions regarding regulatory progress, commercialization plans, and business operations, such statements are based on current expectations and assumptions that are subject to risks and uncertainties and involve a number of risk factors that could cause actual results to differ materially from projected results.

Courtney O'leary: Okay.

Our safe Harbor statement.

Courtney O'leary: This call will contain statements that are forward looking under the private Securities Litigation Reform Act of 1995.

Courtney O'leary: Expectations regarding our future financial results and financial position. In addition to statements are the company's plans expectations or intentions regarding the regulatory product commercialization plans and business operations.

Courtney O'leary: Such statements are based on current expectations and assumptions that are subject to risks and uncertainties and involve a number of best factors that could cause actual results to differ materially from projected results.

Courtney O'leary: A description of these risks is contained in our filings with the SEC, which are available on the Investor Relations section of our website Www Dot Bluebird bio dotcom.

Courtney O'leary: A description of these risks is contained in our filings with the SEC, which are available on the investor relations section of our website, www.bluebirdbio.com. On today's call, Andrew Obenshain, Bluebird Bio's CEO, will provide opening remarks. Then, Tom Klima, Chief Commercial and Operating Officer, will discuss progress on the commercial launches of Liftgenia, Zentegro, and SkySona. And finally, Chris Krawtschuk, Chief Financial Officer, will provide a financial update before opening the call for Q&A. With that, I will turn it over to Andrew.

Speaker Change: On today's call Andrew Albert Chi, whereby our CEO will provide opening remarks, and Tom cleanup Chief commercial and operating officer will discuss progress on the commercial lunches uplift Jennie O <unk> and Sky.

Speaker Change: Finally, Chris Koch, our Chief Financial Officer will provide a financial update before opening the call up for Q&A with that I'll turn it over to Andrew Thanks, Courtney and thank you everyone for joining the call. This morning, as we provide an update on our first quarter 2024 results and recent highlights.

Andrew Obenshain: Thanks, Courtney, and thank you, everyone, for joining the call this morning as we provide an update on our first quarter 2024 results and recent highlights. I'm thrilled to be here today on the heels of our first Lithuanian commercial cell collection, which we announced earlier this week. Nearly a decade after we began clinical development for Lifgenia for sickle cell disease, seeing a patient initiate commercial treatment for our gene therapy is a monumental milestone, both for Bluebird, for the researchers and the clinicians who worked tirelessly on this program, and also for the sickle cell community who have been our partners every step of the way.

Andrew Obenshain: Thrilled to be here today on the heels of our first with Kenya commercial soft collection, which we announced earlier this week.

Andrew Obenshain: Nearly a decade after we began clinical development to Ms. Jenny <unk> for sickle cell disease.

Andrew Obenshain: The patient initiated commercial treatment for our gene therapy is a monumental milestone both for Bluebird for the researchers and clinicians who worked tirelessly on this program and also for the sickle cell community, who have been our partners every step of the way.

Andrew Obenshain: Now with our first patient start completed, and with a strong established commercial foundation in place, Bluebird is poised for accelerated growth throughout the rest of 2024. We look forward to sharing more updates as momentum builds. I will now hand the call over to Tom to discuss the progress in our commercial launches in greater Washington, D.C. Thanks, Andrew.

Andrew Obenshain: Now with our first with Kenya patient start completed and with a strong established commercial foundation in place Newberg is poised for accelerated growth throughout the rest of 2024.

Andrew Obenshain: Third to sharing more updates as momentum builds.

Andrew Obenshain: I will now hand, the call over to Tom to discuss the progress in our commercial launches in greater detail.

Thomas J. Klima: Thanks, Andrew. And good morning, everyone.

Thomas J. Klima: This week, we achieved yet another amazing milestone in our gene therapy journey at Bluebird with our first commercial patient start for Lipgenia. Over the past year, we have pointed to the benefits of our commercial head start and the foundation we built with Syntaglo for beta thalassemia and Skysona for cerebral adrenal leukodystrophy. And today, we are seeing not only that momentum build for our first two launches, but these synergies are coming to fruition for Lipgenia. As a reminder, our launches are focused on three core elements for success.

Tom: Thanks, Andrew and good morning, everyone. This week, we achieved yet another amazing milestones in our gene therapy journey at Blue Bird with our first commercial patient start from a junior.

Tom: Over the past year, we are pointing to the benefits of our commercial head start and the foundation, we built with <unk> for beta thalassemia and sky sooner for cerebral adrenoleukodystrophy.

Tom: We are seeing not only that momentum build for our first two launches, but also these synergies are coming to fruition for la <unk>.

Tom: As a reminder, our launches are focused on three core elements for success.

Thomas J. Klima: First, establishing a robust network of qualified treatment centers, or QTCs. These are transplant centers with significant experience in cell and gene therapy. Today, we have 64 activated QTCs, unparalleled compared to others in the

Tom: First establishing a robust network of qualified treatment centers or Q T sees these transplant centers with significant experience in cell and gene therapy. Today, we have 64 activate acute gcs unparalleled compared to others in the field.

Thomas J. Klima: Second, ensuring the value of our therapies and that patients have timely, equitable access, and lastly, optimizing the patient and provider experience. Gene therapy requires a high-touch approach, and transparency, collaboration, and understanding the needs of patients, families, and providers are paramount. Our deep understanding of the gene therapy process, our dedicated focus, and our experience over the last 18 months allow us to be a strong partner to our activated QTCs as we help them bring life-changing therapies to their patients.

Tom: Ensuring the value of our therapies is recognized and that patients have timely equitable access and lastly, optimizing the patient and provider experience.

Tom: Gene therapy requires a high touch approach and transparency collaboration and understanding the needs of patients families and providers is paramount.

Tom: Deep understanding of the gene therapy process, our dedicated focus and our experience over the last 18 months allow us to be a strong partner to our activated <unk> as we help them bring life changing therapies to their patients.

Thomas J. Klima: We are extremely encouraged by the excitement in the sickle cell community and the number of patients preparing for treatment. As we sit here today, more than half of our Lefgenia QTCs have communicated to us that they are actively evaluating patients for gene therapy initiation, and one quarter of our centers are in the prior authorization process for one or more patients. As a reminder, the journey to a patient start or cell collection takes time.

We are extremely encouraged by the excitement in the sickle cell community and the number of patients preparing for treatment as we sit here today more than half of our lip journey of acute tcs have communicated to us that they are actively evaluating patients for gene therapy initiation and one quarter of our centers are in the prior authorization process for one.

Tom: More patients.

Tom: As a reminder, the journey to a patient start or cell collection takes time.

Thomas J. Klima: While every patient is different, the typical path for a patient to first initiate a consultation with a transplant or at a QTC, then to enroll in My Bluebird support, and then, often concurrently, the QTC will initiate reimbursement negotiations with the payer, while also taking steps to ensure clinical readiness, which includes a two-month washout period for hydroxyurea. These steps must be coordinated, and the patient's health must be considered.

Tom: Every patient is different the typical path for a patient to first initiated consultation with a transplant Arctic UGC then to enroll in my Blue Bird support and then often concurrently the UTC will initiate reimbursement negotiations with the payer while also taking steps to ensure clinical readiness, which includes a two month washout period.

For Hydroxyurea. These.

Tom: These steps must be coordinated in the patient's health it must be considered.

Thomas J. Klima: With that in mind, we continue to anticipate revenue for Lipgenia to grow quarter over quarter with the majority occurring in the second half of the year as momentum builds and factoring in the time for drug product manufacturing. Once the patient cells are collected, we anticipate that first revenues for Lipgenia will be recorded, reported in Q3. Moving to Zynteglo, we continue to see strong linear growth with 11 patient starts since the beginning of 2024.

Tom: With that in mind, we continue to anticipate starts to lift tenure to grow quarter over quarter with the majority occurring in the second half of the year as momentum builds and factoring in the time for drug product manufacturing once the patient cells are collected we anticipate that first revenues from Virginia will be recorded reported in Q3.

<unk>, we continue to see strong linear growth with 11 patient starts since the beginning of 2024 as we previously shared in mid 2023, we initiated steps to increase drug product manufacturing capacity for <unk> sirona commensurate with demand through our experience in the market. We are also determined that.

Thomas J. Klima: As we previously shared, in mid-2023, we initiated steps to increase drug product manufacturing capacity for Zynteglo and SkySona commensurate with demand. Through our experience in the market, we have also determined the need to increase adherent vector supply, and we've initiated steps to bolster supply to meet the launch trajectory.

Tom: Need to increase adherence factor supply and.

Tom: And we've initiated steps to bolster supply to meet the launch trajectory.

Thomas J. Klima: Additionally, we have completed three patient starts for Skysonis since the beginning of 2024. As a reminder, patient starts, which is when cell collection occurs, remain the key commercial metric to watch in the early stages of our launch, as this is the value-creating moment for the company, with revenue being recognized when the patient is in. For modeling purposes, you can continue to expect that patients are infused one to two quarters following cell collection. In our experience, once a patient goes through cell collection, they continue on the treatment journey and are dedicated.

Tom: Additionally, we have completed three patient starts for <unk> since the beginning of 2024.

Tom: As a reminder, patient starts which is when cell collection occurs remain the key commercial metric to watch in the early stages of our launch as this is the value creating moment for the company with revenue being recognized when the patient is infused for modeling purposes. You can continue to expect that patients are infused one to two quarters following silica.

Tom: <unk>.

Tom: In our experience once the patient goes through cell collection. They continue on the treatment journey and are dedicated to date every patient who has started the process has completed or remained in the process and we continue to expect between 85 and 105 patient starts across our commercial portfolio in 2024.

Thomas J. Klima: To date, every patient who started the process has completed or remained in the process, and we continue to expect between 85 and 105 patient starts across our commercial portfolio in 2024. Now moving to access and reimbursement. Our validated strategy from our Zintegro and SkySono experience is driving favorable coverage for Lithuania. We are very pleased to have our cost-effectiveness model for Lifegenea peer-reviewed and published in the Journal of Pharmacoeconomics in April. The publication offers significant insight into the potential lifetime impact that reducing or eliminating DOE-associated pain crises may have on patients' health and well-being, healthcare utilization, future earnings, and life opportunities.

Tom: Now moving to access and reimbursement are validated strategy for MRSA and <unk> and Sky zone experience is driving favorable coverage for Lyft journey we.

Tom: We are very pleased to have our cost effectiveness model to lip journey of peer reviewed and published in the journal of Pharmacodynamics in April.

Tom: The publication offers significant insight into the potential lifetime impact that reducing or eliminating.

Tom: Associated pain crises may have on patients' health and wellbeing health care utilization future earnings and life opportunities. The publication founded lip journey as cost effective up to a price of $3 $9 million.

Thomas J. Klima: The publication found that Lipgeny is cost-effective up to a price of $3.9 million. The value is being recognized, and we are making great progress securing access for patients with sickle cell disease. Just five months post-launch, both commercial and Medicaid-insured patients have successfully obtained prior authorization for lift generation. Additionally, we have multiple outcomes-based agreements signed for Lithuania with national commercial payoff organizations and have published coverage policies in place for more than 200 million U.S. lives.

Tom: The value is being recognized and we are making great progress securing access for patients with sickle cell disease.

Tom: Just five months post launch both commercial and Medicaid insured patients has successfully obtained prior authorization for Lyft Junior.

Tom: Additionally, we have multiple outcomes based agreements signed for lip Kenya with national commercial payer organizations.

Tom: Have published coverage policies in place for more than 200 million U S lives.

Thomas J. Klima: Our goal has always been timely, equitable access to Lifgenia, irrespective of a patient's insurance type. Discussions are ongoing with Medicaid agencies representing 80% of Medicaid-insured individuals with sickle cell disease in the U.S. Additionally, timely access to Zynteglo and Sky Sona has continued with zero ultimate denials for either therapy across both Medicaid and commercial payers. Moving to our QTC network, we have established a substantial QTC footprint very quickly following Lufgenia's approval. Today, Bluebird has activated 64 QTCs for Lufgenia and Zantaglo.

Tom: Our goal has always been timely equitable access to Virginia irrespective of the patients insurance type discussions are ongoing with Medicaid agencies, representing 80% of Medicaid insured individuals with sickle cell disease in the U S.

Additionally, timely access to <unk> and Sky Solar has continued with zero ultimate denials for either therapy across both Medicaid and commercial payers.

Tom: Moving to our <unk> network, we have established a substantial Q Tc footprint very quickly filing with Jenny as approval today Bluebird is activated 60 <unk> four <unk>.

Christopher Krawtschuk: We were able to quickly transition these centers for Lifginia due to both the learning experience of setting up these centers for Zantaglo and the strong relationships we've built with these centers during 2023. As of this writing, 11 QTCs have started their first patient for one of our products, and the majority of sites who have started their first patient have started their second or third. While we anticipate we may bring on a handful of additional centers throughout 2024, our focus has shifted to patient pull-through at our 64 centers and deepening their experience with Bluebird's gene therapy portfolio.

Tom: We were able to quickly transition these centers for la <unk> due to both for learned experience of setting setting up these centers for <unk> and the strong relationships. We've built with these centers during 2023.

Tom: 11, Q Tcs have started their first patient for one of our products and the majority of sites who started their first patients have started their second or third.

Tom: While we anticipate we may bring on a handful of additional centers throughout 2024, our focus has shifted to patient pull throughout our 64 centers and deepening their experience with blue birds gene therapy portfolio. Additionally, six centers in our network are also activated to administer <unk> for patients with C. L D.

Christopher Krawtschuk: Additionally, six centers in our network have also been activated to administer Skysona for patients with CALD. To recap, Zynteglo and Skysona launches continue to progress as planned, and we anticipate strong linear growth for Zynteglo in 2024, along with 5 to 10 patient starts for Skysona. We are extremely excited about the early progress in our Lichenia launch, building on our validated commercial platform. And, most importantly, gene therapy is becoming a reality for patients in the United States.

Tom: To recap since <unk> and Sky Center launches continue to progress as planned and we anticipate strong linear growth for <unk> in 2024, along with 5% to 10 patient starts for <unk>. We are extremely excited about the early progress in our lift Ginia launch building on our validated commercial platform and most importantly.

Tom: <unk> therapy is becoming a reality for patients in the United States. We look forward to updating you as our momentum builds in our lunches and patient starts grow over the next few quarters and now I would like to turn the call over to Chris.

Christopher Krawtschuk: We look forward to updating you as our momentum builds in our launches and patients start to grow over the next few quarters. Now, Tom, and good morning, everyone.

Christopher Krawtschuk: In the first quarter, we reported $18.6 million in total revenue, driven by revenue from Zenteglo. As a reminder, we recognize revenue upon the infusion of the drug product. As previously guided in 2024, we anticipate gross net discounts in the range of 20 to 25% with fluctuations based on product mix, payer mix, as well as utilization of our outcomes-based agreement. As of March 31st, 2024, we had $264 million in cash on hand, inclusive of $52 million in restricted cash.

Christopher Krawtschuk: Tom and good morning, everyone.

Christopher Krawtschuk: In the first quarter, we reported $18 6 million in total revenue driven by revenue from Integra.

As a reminder, we recognize revenue upon infusion of the drug product.

Christopher Krawtschuk: As previously guided in 2024, we anticipate gross to net discounts in the range of 20% to 25% with fluctuations based on product mix payer mix as well as utilization of our outcomes based agreements.

Christopher Krawtschuk: As of March 31, 2024, we had $264 million in cash on hand inclusive of $52 million in restricted cash.

Christopher Krawtschuk: Based on our current business plans, including our ability to achieve certain commercial revenue milestones, we have a cash runway through Q1 of 2026. This runway includes our current cash equivalents and also assumes that we receive the two remaining tranches totaling $50 million from our term loan facility. Additionally, we continue to work expeditiously to complete our restatement and file our 2023-10-K and Q1 2024-10-Q. I want to personally thank and recognize the tremendous work and unwavering dedication of the bluebird finance and accounting teams that are finalizing the restatement. Importantly, and as a reminder, the restatement is not expected to impact our cash position or our revenue. With that, I'll turn it back over to Andrew.

Christopher Krawtschuk: Based on our current business plans, including our ability to achieve certain commercial revenue milestones, we have a cash runway through Q1 of 2026.

Christopher Krawtschuk: This runway includes our current cash equivalents and also assumes that we received the two remaining tranches totaling $50 million from our term loan facility.

Christopher Krawtschuk: Additionally, we continue to work expeditiously to complete our restatement and file our 2023 10-K, and Q1 2024 10-Q.

Christopher Krawtschuk: I want to personally thank and recognize the tremendous work and unwavering dedication of the Bluebird finance and accounting teams that are finalizing the restatement.

Christopher Krawtschuk: Importantly, and as a reminder, the restatement is not expected to impact our cash position or our revenue.

Christopher Krawtschuk: With that I'll turn it back over to Andrew.

Andrew Obenshain: Thanks, Chris. As we highlighted today, it's an exciting time for Bluebird. We stand in the midst of a monumental year with the potential for growth on the near-term horizon. And with that, I'd like to open it up to questions. Operator?

Andrew: Thanks, Chris.

Andrew: Highlighted today is an exciting time for Bluebird, we stand in the midst of a monumental year, where the potential for growth in the near term horizon.

Andrew: With that I'd like to open it up for questions operator.

Operator: Thank you, and as mentioned, the floor is now open for questions. To ask a question, please press star one on your telephone keypad to raise your hand and join the queue. In the interest of time and to ensure we cover as many participants as possible, we do request a limit of one question and one follow-up per person. And your first question comes from the line of Jason Gerberry from Bank of America. Your line is open.

Speaker Change: Thank you and as mentioned the floor is now open for questions to ask a question. Please press star one on your telephone keypad to raise your hand and joined the queue in the interest of time and to ensure we cover as many participants as possible. We do request a limit of one question and one follow up per person.

Speaker Change: And your first question comes from the line of Jason <unk> from Bank of America. Your line is open.

Jason Gerberry: Morning. Thanks for taking my question, guys. I guess I'll ask a question about the, just the update on the Medicaid reimbursement work that's ongoing and curious. I think we asked this question last quarter, but just wanted to make sure that it's not a rate-limiting factor at all for new patient starts for Lifgenia as you build up the Medicaid reimbursement coverage. And just trying to put that in context relative to your competitors' updates on their new starts, I guess the question is one of, are they watching faster in the U.S., or is their new patient start number more just a function of a broader geographical reach?

Jason: Good morning, Thanks for taking my question guys.

Jason: I guess I'll ask a question about the.

Jason: Just the update on the Medicaid.

Jason: Reimbursement work, that's ongoing and curious I think we asked this question last quarter, but just wanted to make sure that it's not a rate limiting factor at all to <unk>.

Jason: New patient starts for <unk>.

Jason: As you build up the Medicaid reimbursement coverage.

Jason: And just trying to put that in context relative to your competitors update on their new starts I guess the question is one of are they watching faster in the U S or is there new patient start number more just a function of a broader geographical reach.

Andrew Obenshain: Yeah, morning Jason. I'll hand that over to Tom. Why don't we take them in order, kind of in reverse order? Why don't we talk about the patient starts first and then talk about Medicaid as well. Go ahead.

Speaker Change: Yes, good morning, Jason I'll hand that over to Tom Let me take those in order kind of reverse order, while we talk about the patient starts first.

Tom: And then talk about the Medicaid as well go ahead, yes. Good morning, Jason we're extremely pleased with what we're seeing in terms of starts obviously, we have a tremendous head start with <unk>.

Thomas J. Klima: We're extremely pleased with what we're seeing in terms of starts. Obviously, we have a tremendous head start with Syntaglo and a lot of progress there, but when you look at Lifgenia, we have multiple patients in multiple QTCs going through the initiation process for gene therapy and are very excited about the first collection. We're really not going to comment about, you know, what the competitor is doing, but, you know, more so, I think we feel really good about what we're seeing with Lifgenia.

Speaker Change: Progress there, but when you look at Lyft journey.

Tom: We have multiple patients and multiple <unk> going through the initiation process for gene therapy.

Tom: And Im very excited about the first collection.

Tom: We're really not going to comment about what the competitors doing but more so I think we feel really good about what we're seeing with <unk>.

Thomas J. Klima: As far as Medicaid is concerned, it's not a rate-limiting factor. Obviously, we've been working with Medicaid for many, many years now to make sure they understand and recognize the value of a one-time potentially curative therapy. Also, offering our outcomes-based agreement and tying that to the value of our therapy. In the meantime, until they have coverage policies or, you know, sign up for our outcomes-based agreement, they can always have access. Basically, patients can have access to the medical acceptance process, so it's really not a barrier for patients.

Tom: As far as Medicaid, it's not a rate limiting factor obviously, we've done work with Medicaid for many many years now.

Tom: Making sure they understand and recognize the value of a onetime potentially curative therapy also offering our outcomes based agreement.

Tom: That's the value of our therapy and in the meantime until they have coverage policies or.

Tom: The centre for outcomes based agreement. They can always have access basically patients can have access through the medical exceptions process. So it's really not a barrier for patients.

Speaker Change: Got it thank you.

Jack Kilgannon Allen: Your next question comes from the line of Jack Allen from Baird. Please go ahead.

Speaker Change: Your next question comes from the line of Jack Allen from Baird. Please go ahead.

Andrew Obenshain: All right, thank you so much for taking my question. I guess to start, I wanted to ask you about studying Lithgenia in younger patients. Do you have a study ongoing? And how are things progressing as it relates to expanding access as it relates to age for Lithgenia?

Alright. Thank you so much for taking my question I guess to start I wanted to ask about your.

Jack Kilgannon Allen: Your thoughts as it relates to starting with genuine in younger patients do you have a study ongoing and how are things progressing as it relates to expanding access there is early stage, but of a tenure.

Andrew Obenshain: Yeah, thanks for the question, Jack. So we have a trial on HDB210 ongoing in pediatric patients. Enrollment is ongoing. We anticipate to complete that by Q4 2024. And that's going to evaluate patients 2 to 12 for left genia. As a reminder, for syntagma, we have an indication down to the age of

Jack Kilgannon Allen: Yes.

Thanks for the question Jack So.

Speaker Change: We have a trial in ACB Q10 onward in pediatric patients that enrollment is ongoing we anticipate to complete that by Q4 2024.

Speaker Change: And thats going to evaluate patients two to 12.

Speaker Change: For a lot of left Kenya, as a reminder, present <unk>, we have an indication down to age of two.

Jack Kilgannon Allen: Got it. Great. And then I'll give it a shot here.

Speaker Change: Got it great and then I'll give it a shot here I'm not sure.

Speaker Change: I'll get on this but how many patients are in the Bluebird support system as it relates to China do you have any idea about the pull through of those patients at baseline is in Taiwan is there anything to read through there as it relates to people starting that uptick in the process.

Thomas J. Klima: I'm not sure what kind of reception I'll get on this, but how many patients are in the bluebird support system as it relates to Lipgenia? Do you have any idea about the pull-through of those patients based on your Zantaglo experience? Is there anything to read through there as it relates to people starting that aspect of the process?

Speaker Change: Yes. Good question, Jack we've learned a lot through everything <unk> experienced were not going to comment individually on the pull through because I think when you look at beta thalassemia and it's a lot different in patients who have sickle cell disease, and it's kind of early in the process right now with obviously a small end for Lyft tenure, so we really don't want to call.

Speaker Change: Rent on that but I will tell you that there are a lot of patients who are very excited for gene therapy. As I said, there are multiple patients across multiple <unk> initiating the process and usually once they start the process. They are committed and continue through the process. So we're we're just excited with the momentum we're seeing and we look forward to getting more Dave.

Thomas J. Klima: Yes, a good question, Jack. You know, we've learned a lot through our Zynteclo experience. We're not going to comment individually on the pull through because I think, you know, when you look at beta thalassemia, it's a lot different than patients who have sickle cell disease. And it's kind of early in the process right now with obviously a small N for Lipgenia. So we really don't want to comment on that.

Jack Kilgannon Allen: But I will tell you that there are a lot of patients who are very excited about gene therapy. As I said, there are multiple patients across multiple QGCs initiating the process. And usually, once they start the process, they're committed and continue through the process. So we're just excited with the momentum we're seeing. And we look forward to, you know, getting more data as the year progresses.

Speaker Change: As the year progresses.

Jack Kilgannon Allen: Great, thanks so much for taking the questions.

Great: Great. Thanks, so much for taking the questions.

Danielle Catherine Brill Bongero: Your next question comes from the line of Danielle Brill from Raymond James. Please go ahead.

Great: Your next question comes from the line of Danielle Brill from Raymond James. Please go ahead.

Great: Yeah.

Danielle Catherine Brill Bongero: Morning, this is Daniel Ong for Daniel. We have a question about the QTC being qualified for both Koskove and Virginia. Any particular reason why the patient chose to pursue the treatment with Virginia? And have you seen any push and pull from payers deciding on either therapy?

Great: This is Daniel on for Danielle.

Daniel: We have a question on the.

Daniel: <unk> is caused by for both Costco and with genuine any particular reason for the patients chose to pursue the treatment with <unk>.

Speaker Change: And have you seen any like push and pull from payers deciding.

Speaker Change: Either therapy. Thank you.

Danielle Catherine Brill Bongero: Thank you.

Speaker Change: Scott Thanks for the question. Tom Go ahead, yes, good morning, Daniel.

Thomas J. Klima: Thanks for the question, Tom. Go ahead. Yeah, good morning, Daniel.

Thomas J. Klima: Go ahead. Yeah. Good morning, Daniel.

Thomas J. Klima: As far as offering both therapies is concerned, we have a head start, obviously, with 64 qualified treatment centers. However, it is our expectation that most qualified treatment centers will offer both therapies, Lifgenia and the other gene therapy. We haven't seen many centers saying they're going to offer one or the other or exclude one or the other. I think most centers believe that choices for patients are good, and if they have both onboarded already, which is only a small handful, then they present both to the patient, and it becomes a patient choice.

Tom: As far as offering both therapies, we haven't we have a head start obviously with 64 qualified treatment centers. However.

Tom: However, it is our expectation that most qualified treatment centers will offer both therapies lift.

Tom: <unk> journey and the other gene therapy.

Tom: We haven't seen many centers, saying, they're going to offer one or the other or exclude one or the other.

Tom: Most centers believes that choices for patients are good.

Tom: If they have both on boarded already which is only a small handful then they present both to the patient and becomes a patient choice.

Speaker Change: Thank you.

Huidong Wang: Your next question comes from the line of Gina Wang from Barclays. Please go ahead.

Speaker Change: Your next question comes from the line of Gena Wang from Barclays. Please go ahead.

Huidong Wang: Thank you for taking my questions. Maybe also asking about the 64 QTC, out of these, how many of these actually were active for left genia? And also for the first patient, I don't know if you can share that detail, how many cycles of cell collection in order to start the manufacturing?

Gena Wang: Thank you for taking my questions.

Gena Wang: Maybe also asking about that 64 TTC.

Gena Wang: How does this how many of these.

Ashley active for <unk> and also for the first patient I don't know if you can share that detail how many cycles of cells collection in order to stop.

Speaker Change: Stock the manufacturing.

Andrew Obenshain: morning Gina, and actually, I think the second part of that first and hand it over to Tom, for the first part, just we that was the first collection for the patient, we reported their first collection, so we haven't reported whether they how many collections we'll need to miss that, that's it manufacturing is ongoing right now, so we can't comment on that Tom, go ahead, yeah, hi Gina.

Speaker Change: Yes, good morning.

Speaker Change: And actually I think I'll take the second part of that first and hand, it over to Tom for the first part to sweep that was the first collection for the patient we reported their first collection. So we havent reported whether they how many collections will need them is that manufacturing is ongoing right now.

Speaker Change: So we can't comment on that Tom go ahead, Yes, Hi, Gena 64 centers, we're really excited about that.

Thomas J. Klima: The 64 centers, we're really excited about that. Centers really do not want to go through the process of getting onboarded if they don't have patients to treat. So we believe that the 64 centers that we have will evaluate patients for Lifgenia and or Zantaglo as we go forward. And if you look at the dynamics of how we are building out the Qualified Treatment Centers, almost half of the Qualified Treatment Centers have come on board just since approval in December.

Tom: <unk> really do not want to go through the process of getting on boarded if they don't have patients to treat so we believe that the 64 centers that we have.

Tom: We will evaluate patients for la <unk> and tableau as we go forward and if you look at the dynamics of how we build out the qualified treatment center almost half of the qualified treatment centers have come on board just since approval in December.

Thomas J. Klima: So the momentum continues to build, and we're continuing to look at the patients going through the centers. We're really excited that 64 centers are now on board, and many of them have already started the process of evaluating patients.

Tom: <unk> continues to build and if you look at the patients going through the centers.

Tom: We're really excited that 64 centers are now on board and many of them already starting the process of evaluating patients.

Thomas J. Klima: I'm sorry if I can make it clearer. I think last quarter was 49 out of 62 received a referral for left genia, so just wanted to know now 64 out of 64 how many of these received a referral for left genia Yeah, it's about

Speaker Change: And I'm, sorry, if I can make it clear I think last quarter with 49 out of 62 with <unk> with BRL four left Jami. So just wanted to know now 64 out of 64, how many of these receive referrals for <unk>.

Thomas J. Klima: Yeah, it's about 50 of the 64, and we anticipate that almost all of them will be on board very soon. It's just a matter of completing some final steps. In some cases, you won't see all of them on our website, because some of them have chosen not to be listed on our website.

Speaker Change: Yes, it's about 50 of the 64, and we anticipate that almost all of them will be onboard very soon it's just a matter of completing some final steps.

Speaker Change: And in some cases, you will see all of them on our website give some of them have chose not to be listed on our website.

Speaker Change: Okay, great. Thank you.

Eric William Joseph: Your next question comes from the line of Eric Joseph from JP Morgan. Please go ahead.

Speaker Change: Your next question comes from the line of Eric Joseph from JP Morgan. Please go ahead.

Eric William Joseph: Thanks. Good morning.

Eric William Joseph: Got it thanks good morning.

Eric William Joseph: The added.

Eric William Joseph: Color that you're providing here on sort of.

Eric William Joseph: Products.

Eric William Joseph: Collections within the <unk> network is pretty interesting can you talk a little bit more about sort of what.

Eric William Joseph: Separates the initial 11 UTC is that true.

Eric William Joseph: Treated patients so far versus the balance.

Eric William Joseph: The added color that you're providing here on product collections within the QTC network is pretty interesting. Can you talk a little bit more about sort of what separates the initial 11 QTCs that have treated patients so far versus the balance? I wonder whether it's perhaps bed capacity or patient demand or something in the pre-authorization process that has the first group kind of moving a little more swiftly. And then, a follow-up to this Times article featuring your first patient collection with Lopchenia, the article notes that Children's National has a capacity of about 10,000.

Eric William Joseph: I wonder whether.

Eric William Joseph: It's perhaps bed capacity year patient demand or something in the Preauthorization pre authorization process that has the first group kind of moving a little more swiftly.

Eric William Joseph: Then.

And a follow up to this.

Eric William Joseph: Times article featuring their first patient collection with Love journey.

Eric William Joseph: The article notes children's National has a capacity of about 10.

Eric William Joseph: Capacity to do about 10 gene therapy treatments a year. Can you talk about how representative that capacity is across your QTC network? Do you anticipate any efforts to kind of expand that in a way that would support uptake? Thank you.

Eric William Joseph: Capacity due to steel about 10 gene therapy treatments a year can you talk about how representative that capacity across our <unk> network.

Eric William Joseph: Anticipate any efforts to kind of expand that in a way that would support.

Speaker Change: Uptake thank you.

Thomas J. Klima: Go ahead, Tom. Yeah, good morning, Eric. Two great questions. The first question, I can probably answer that in two different ways. I think if you consider the dynamics of when we brought in the QTCs, you know, we really focused on the first 10 to 15 for the most part, you know, the first half of last year, and then we rapidly accelerated into the end of last year and the start of this year. So if you look at those initial 10 to 15, now you're seeing roughly 11 are treating at least one patient or going on to treat their second and third patient. The second component is just time.

Speaker Change: Go ahead, yes, good morning, Eric.

Speaker Change: Great questions.

First question, probably I can answer that two different ways I think if you consider the dynamics of when we brought on the <unk>.

Speaker Change: We really focused on the first 10 to 15 for the most the first half of last year and then we rapidly accelerated into the end of last year and the start of this year. So if you look at those initial 10% to 15 now youre seeing roughly 11 are treating at least one patient or going on to treat their second and third patient.

Thomas J. Klima: If you look at the sickle cell patient journey for sickle cell disease, it just takes time from, you know, the initial consultation, going back and discussing it with their family, going through the process of getting prior authorization, and then being medically ready, you know, making sure they're stopping their hydroxyurea for two months and going through transfusions. I would say the early adopters kind of saw this in advance, and we were thinking about patients, and patients were already calling in prior to approval, and that's why you're seeing some QTCs get off to a faster start.

Speaker Change: The second component is this time, if you look at the sickle cell patient journey for sickle cell disease. It just takes time from the initial consultation going back and discussing them with their family going through the process of getting the prior authorization and then being medically ready, it's making sure they're stopping their hydroxyurea for two months and going through <unk>.

Speaker Change: <unk> fusions I would say the early adopters.

Speaker Change: In advance and we're thinking about patients and patients who are already calling in the prior to approval and Thats why youre seeing some gtc's get off to a faster start.

Speaker Change: Okay.

Thomas J. Klima: And the second part of your question about the New York Times article: very inspiring to see, you know, that patient go through the start of the process. I would say if you've seen one qualified treatment center, you've seen one qualified treatment center. So I wouldn't say that that's necessarily representative, but I would say that most of the large QTCs are filling out, you know, large capacities for cell and gene therapy.

Speaker Change: And the second part of your question around the New York Times article very inspiring to see the.

Speaker Change: That as you go through the start of the process.

Speaker Change: I would say if you've seen one qualified treatment centers, you've seen one qualified treatment center.

Speaker Change: So I wouldn't say, that's necessarily representative, but I would say that most of the large <unk> are building out.

Speaker Change: Large capacities for cell and gene therapy.

Thomas J. Klima: Okay, thanks. Oh, maybe just a quick follow-up to that. Did Children's National, or has it treated any patients with Syntec?

Speaker Change: Okay. Thanks.

Speaker Change: A quick follow up to that to children's National warehouse children's National.

Speaker Change: Treated any patients with some type of level.

Thomas J. Klima: And we are not going to comment individually by QTC by QTC on that information, but I think they're obviously one of the 11 that have treated patients. So, many of those many QTCs have now gone on to their second and third. So I'll just say it that way.

Speaker Change: And we're not going to comment individually by PTC by PTC on that information, but but.

Speaker Change: Obviously, one of the 11 next treated patient cell and many of those many of those <unk> have announced their second and third so I'll just say it that way.

Speaker Change: Okay. Thank you very much.

Eric Thomas Schmidt: Your next question comes from the line of Eric Schmidt from Cantor Fitzgerald. Please go ahead.

Speaker Change: Your next question comes from the line of Eric Schmidt from Cantor Fitzgerald. Please go ahead.

Eric Thomas Schmidt: Thanks for taking my questions. In terms of the new start guidance for 2024, I just want to maybe put a finer point on how you're quantifying a new start or qualifying a new start. Is it from the time a patient's first collection has been completed? Does that make them a new start?

Eric Thomas Schmidt: Thanks for taking my questions in terms of the new start guidance for 2024, just wanted to maybe put a finer point on how you are.

Eric Thomas Schmidt: Quantifying a new start of qualifying a new start is it.

Eric Thomas Schmidt: From the time of patients first collection has been completed does that make them a new a new start.

Eric Thomas Schmidt: Go ahead, Tom Yeah. Good morning, Eric So we've been pretty consistent in how we define new patient starts.

Tom: Since the beginning.

We really believe that the metric to watch as the first unique cell collection. When the silk collection is complete we believe that once a patient goes through that process that it's highly likely that they will go through the entire journey and ultimately get treated and infused at the end of the day. So we define it by that unique first cell collection being completed.

Speaker Change: Thanks for that information, maybe maybe for Chris.

Speaker Change: <unk> into uncharted waters with regard to the restatement is there anything you can say on how Cogs are trending opex cash burn in Q1 I.

Speaker Change: I guess I'm struggling with.

Speaker Change: Being able to understand your financial state right now.

Speaker Change: Great Chris.

First I'll say that the.

The restatement will not have an impact on.

Speaker Change: Cash or will have an impact on the key metrics of the company such as patient starts et cetera. That's why we continue to make that message I'm not going to comment on the other elements of the lines of the P&L associated with where we're trending just because we're in the process of the restatement and it's not fair or appropriate to comment.

Speaker Change: Do you have a better sense on when we will see those numbers.

Speaker Change: We have the skills that we're working expeditiously to complete the restatement were not providing a time line associated with when that will occur.

Speaker Change: You.

Leerink: Your next question comes from the line of many for her from Leerink. Please go ahead.

Leerink: Hey, guys. This is Ryan on for Bonnie Thanks for taking our question.

Ryan: Kind of a two parter one we were just wondering how should we think about the pace of sell collections for lip journey as we go through the year or are we going to start to reach a steady state at some point do we see this accelerating into the end of the year and then kind of dovetail off of that can you guys talk about what specific actions are field team is taking to kind of.

To help accelerate the lift Jennie O launch, whether it's through Q Tcs are core engaging with physicians et cetera. Thanks.

Thomas J. Klima: Go ahead, Tom. Yeah, good morning, Eric.

Ryan: Go ahead, Tom Yes, good morning, Ryan we really we've said all along we expect the trajectory of our starts to really accelerate and ramp into the end of the year and in Q4, Q3, and Q4 and the field team has shifted their focus completely from bringing new qualified treatment centers onboard to now focusing on <unk>.

Thomas J. Klima: So we've been pretty consistent in how we define new patient starts, you know, since the beginning. We really believe that the metric to watch is the first unique cell collection. When the cell collection is complete, we believe that once a patient goes through that process, it's highly likely that they'll go through the entire journey and ultimately get treated and infused at the end of the day. So we define it by that unique first cell collection being completed.

Ryan: <unk> qualified treatment centers in pulling through patients and making sure that they are ready and poultry patients. So we're.

Ryan: Completely shifting gears our field team as Bill has built great relationships with the qualified treatment centers over the last year and a half.

Ryan: A lot of credibility and rapport, but now completely focused on supporting patient pull through.

Speaker Change: Awesome. Thank you.

Christopher Krawtschuk: Thanks for that information. Maybe for Chris, you know, we're kind of flying into uncharted waters with regard to the restatement. Is there anything you can say about how COGS is trending, OPEX, cash burn, and Q1? I guess I'm struggling with being able to understand your financial state right now.

Speaker Change: Your next question comes from the line of Yanan Zhu from Wells Fargo. Please go ahead.

Christopher Krawtschuk: First, I'll say that the restatement will not have an impact on cash nor will it have an impact on the key metrics for the company, such as patient starts, etc. That's why we continue to emphasize that message. I'm not going to comment on the other elements of the lines of the P&L associated with where we're trending just because we're in the process of restatement, and it's not fair or appropriate to comment on that.

Christopher Krawtschuk: Do you have a better sense of when we'll see those numbers?

Yanan Zhu: Hi, Thanks for taking our question this is <unk>.

Christopher Krawtschuk: We have the skills and are working expeditiously to complete the restatement. We're not providing a timeline associated with when that will occur.

Mani Foroohar: Your next question comes from the line of Mani Foroohar from Lerink. Please go ahead.

Yanan Zhu: Quick question on Julian.

Yanan Zhu: So any colors on how many patients are there.

Speaker Change: Oh hi.

Speaker Change: We have one show.

Speaker Change: So I think the question was how many patients have started hydroxyurea washout.

Speaker Change: So it varies we were banking to really give guidance on that and it varies by not only patient by by qualified treatment Center.

Speaker Change: Patients are on Hydroxyurea, some patients or not some qualified streamer said the qualified treatment centers have different sops in terms of when they start that washout period.

Speaker Change: Obviously.

Speaker Change: Wanted to start some of the medical readiness concurrently with some of the prior authorization work that they need to do.

Speaker Change: And thats pretty consistent, but we arent, giving guidance on kind of some of the precursors before the cell collection.

Speaker Change: Got it thank you.

Speaker Change: One quick question on manufacturing so what's your current capacity CMO for ammonia.

Speaker Change: Is there any additional investment if we want to increase the capacity in the future. Thank you.

Speaker Change: So the.

Speaker Change: I think the question about capacity for Lyft, Kenya, and I think David talking about drug product capacity. So we do have a separate supply chain from China that is integral sky solar that we do have a more robust supply.

Speaker Change: On the Jennie O side in anticipation of a higher volume and we also have the ability to increase that that supply as we see demand come in so we've always said, we're going to match, how we bring on new capacity with how we see the demand come in.

Speaker Change: It is close to lockstep as possible.

Speaker Change: Got it thank you so much.

Speaker Change: Your next question comes from the line of Luke AC from RBC. Please go ahead.

Ryan Anfermani: Hey guys, this is Ryan Anfermani. Thanks for taking our question. It's kind of a two-parter one.

Speaker Change: Oh, great. Thanks for taking our question this is Lisa for Luka.

Lisa: I was wondering if you can talk about whether you are considering launching an ex U S geographies.

Lisa: And then your competitors seems really excited about the middle eastern market, David narrow potentially 23000 eligible patients in that region.

Lisa: So wondering if you are reconsidering and ex U S launch other solo with a partner or utilizing a distributor any thoughts there much appreciated and congrats on all the progress.

Ryan Anfermani: We were just wondering, you know, how should we think about the pace of cell collections for LifGENIA as we go through the year? Are we going to start to reach, you know, a steady state at some point? Do we see this accelerating into the end of the year? And then, you know, kind of dovetail off of that, can you guys talk about, you know, what specific actions your field team is taking to kind of help accelerate the LifGENIA launch, whether it's through QTC support, you know, engaging with physicians, et cetera? Go ahead, Tom. Yeah.

Speaker Change: Yes, thanks very much so right now we are entirely focused on the U S.

Speaker Change: And that's and we will remain focused on the U S for the.

Speaker Change: At the very at least near and probably mid term future.

Speaker Change: <unk> future.

Speaker Change: We are watching the ex U S geographies. If we go there we would most likely go with a partner and not do it alone.

Speaker Change: Got it.

Speaker Change: Your next question comes from the line of semi colon from William Blair. Please go ahead.

Speaker Change: Hi, This is Brett Schuster on firstly I mean, thank you for taking our question.

Brooke Schuster: So of the total of 64 key TC centers activated I guess, what would you say is the biggest bottleneck to the initiation of patient starts and we are also wondering in some of that then peglow patients that had collected in Q4.

Speaker Change: Alright, if all of them been treated already thank you.

Thomas J. Klima: Go ahead, Tom. Yeah, good morning, Ryan.

Thomas J. Klima: We really have, we've said all along, we expect the trajectory of our starts to really accelerate and ramp into the end of the year in Q4, Q3, and Q4, and the field team has shifted their focus completely from bringing new qualified treatment centers on board to now focusing on supporting qualified treatment centers in pulling through patients and making sure that they're ready to pull through patients. So we're completely shifting gears. Our field team has built great relationships with the qualified treatment centers over the last year and a half. You know, a lot of credibility and rapport, but now completely focused on supporting patient pull through.

Speaker Change: Yes, hi, good morning so.

Yanan Zhu: Your next question comes from the line of Yanan Zhu from Wells Fargo. Please go ahead.

Yanan Zhu: Hi. Thanks for taking our question. This is Quan Ang for IANA. So first, a quick question on Lithuania.

Speaker Change: I wouldn't call. It a bottleneck I would just characterize it as time. It just takes time for patients to go through the process.

Thomas J. Klima: So any color on how many patients have started their hydroxyurea washout?

Speaker Change: If you look at sickle cell disease, one big difference in from sickle cell the beta thalassemia with beta thalassemia patients are already basically medically ready theyre going through regular red blood cell transfusions.

Speaker Change: Dan.

Speaker Change: Are identifiable and mostly ready to go for treatment when it comes to sickle cell disease. Many of these patients are not already in acute Tc.

Thomas J. Klima: So I think the question was how many patients have started the hydroxyurea or washout treatment. Yeah, so it varies. We weren't going to really give guidance on that.

Thomas J. Klima: It varies by not only patient but by qualified treatment center. Some patients are on hydroxyurea. Some patients are not. Some qualified treatment centers have different SOPs in terms of when they start that washout period. Obviously, you know, they want to start some of the medical readiness concurrently with some of the prior authorization work that they need to do. And that's pretty consistent.

Speaker Change: Many of them are not doing trends on transfusions currently in there and some of them are on Hydroxyurea. So from a medical readiness perspective.

Thomas J. Klima: But we aren't giving guidance on the kind of some of the precursors before cell collection.

Speaker Change: Takes a little longer for a patient to be ready to go through the treatment process for Lyft Junior.

Yanan Zhu: Got it. Thank you.

The insurance process, obviously takes a little bit of time as well and that starts with the first patient in the first patient usually takes a little bit longer until the <unk> get into a cadence and the payers start to understand more about the cadence of <unk>. So it's really not a bottleneck per se. It just takes time.

Yanan Zhu: And one quick question on manufacturing. So, what's your current capacity at CDMO for Deep Genia? Is there any additional investment needed if you want to increase the capacity in the future?

Speaker Change: And your next question comes from the line of <unk> from Goldman Sachs. Please go ahead.

Thomas J. Klima: Thank you.

Goldman Sachs: Hi, This is <unk> on for soybean. Thanks, so much for taking our question.

Thomas J. Klima: Yeah, so the question about capacity for Lifgenia, and I think it's probably talking about drug product capacity. So we do have a separate supply chain for Lifgenia than for Zantaglos Gysona. We do have a more robust supply on the Lifgenia side in anticipation of a higher volume. We also have the ability to increase that supply as we see demand come in. So we've always said we're going to match how we bring on new capacity with how we see demand come in, so it's as close to lockstep as possible.

Could you just discuss your confidence in achieving a patient with our guidance this year.

Goldman Sachs: We still intend for roughly half of these patients to come try and lift that yeah. Thanks, so much.

Yanan Zhu: Got it. Thank you so much.

Speaker Change: Alright, yes, we're pleased with how the launches are going obviously a lot of momentum building was intaglio. We feel that there is there is consistency with what we're seeing with Sky Solar and then with 64 qualified treatment centers, we're hearing a lot of positive.

Luca Issi: Your next question comes from the line of Luca Issi from RBC. Please go ahead.

Lisa: Oh, great. Thanks for taking our question. This is Lisa for Luca.

Lisa: Just wondering if you can talk about whether you are reconsidering launching an XUS geography. For instance, your competitor seems really excited about the Middle Eastern market, stating there are potentially 23,000 eligible patients in that region. So, wondering if you are reconsidering a next U.S. launch, either solo, with a partner, or utilizing a distributor. Any thoughts there would be much appreciated, and congrats on all the progress. Thanks. Yeah, thanks very much. So right now, we are entirely focused on

Andrew Obenshain: Yeah, thanks very much. So right now, we are entirely focused on the U.S. And that's, and we will remain focused on the U.S. for the very, at least near and probably midterm future. Then we are watching the ex-US geographies; if we go there, we'd most likely go with a partner in

Andrew Obenshain: Your next question comes from the line of Sammy Corwin from William Blair. Please go ahead.

Samantha Danielle Corwin: Hi, this is Brooke Schuster from SAMHEE. Thank you for taking our question. So with a total of 64 QTC centers activated, I guess what would you say is the biggest bottleneck to the initiation of patient starts? And we are also wondering if some of the centaglo patients that had cells collected in Q4 have or if all of them have been treated already.

Thomas J. Klima: Go ahead, Tom. Yeah. Hi. Good morning.

Thomas J. Klima: So, I wouldn't call it a bottleneck. I would just characterize it as time. It just takes time for patients to go through the process. You know, if you look at sickle cell disease, one big difference from sickle cell to beta thalassemia is that with beta thalassemia, patients are already basically medically ready. They're going through regular red blood cell transfusions and, you know, are identifiable and mostly ready to go for treatment. But when it comes to sickle cell disease, many of these patients are not already in a QTC.

Thomas J. Klima: Many of them are not doing transfusions currently, and some of them are on hydroxyurea. So, from a medical readiness perspective, it just takes a little longer for a patient to be ready to go through the treatment process for Lifgenia.

Salveen Jaswal Richter: And your next question comes from the line of Salveen Richter from Goldman Sachs. Please go ahead.

Thomas J. Klima: or Lipgenia. The insurance process obviously takes a little bit of time as well, and, you know, that starts with the first patient. And the first patient usually takes a little bit longer until the QTCs get into a rhythm and the payers start to understand more about the rhythm of the QTCs. So it's really not a bottleneck per se; it just takes time.

Speaker Change: <unk> in terms of patients excited about gene therapy in patients ready for gene therapy. So based on not only what we did kind of prelaunch and the numbers that we're running but also based on what we're hearing in the field today and we remain confident in the 85 to 105 starts this year and obviously that will ramp in the second half of the year as the treatment centers.

Lydia: Hi, this is Lydia on behalf of Salveen. Thanks so much for taking our question. Could you just discuss your confidence in achieving the patient start guidance this year? And do you still intend for roughly half of these patients to come from Listania?

Thomas J. Klima: Go ahead, Tom. Yeah, we're pleased with how the launches are going. Obviously, a lot of momentum building was in Teglo, but we feel that there is consistency with what we're seeing with Geissona and then with 64 qualified treatment centers. We're hearing a lot of positive experiences in terms of patients excited about gene therapy and patients ready for gene therapy. So based on not only what we did kind of pre-launch and the numbers that we were running but also based on what we're hearing in the field today, we remain confident in the 85 to 105 starts this year, and obviously, that will ramp up in the second half of the year as treatment centers get through the process.

Speaker Change: Through the process.

Operator: And that does conclude our Q&A session for today. I would like to hand the call back over to Andrew for his closing remarks.

Speaker Change: And this does conclude our Q&A session for today I would like to hand, the call back over to Andrew for closing remarks.

Andrew Obenshain: Thank you. Thank you everyone for joining our call this morning and for your questions. Our management team is available for follow-up calls today, and please reach out to Courtney if you would like to connect.

Speaker Change: Yes.

Andrew: Thank you.

Andrew: Thanks, everyone for joining our call. This morning and for your questions. Our management team is available for follow up calls today and please reach out to Courtney if you'd like to get that thank you.

Operator: This concludes today's conference call. Enjoy the rest of your day. You may now disconnect.

Speaker Change: This concludes today's conference call enjoy the rest of your day you may now disconnect.

Speaker Change: [music].

Speaker Change: Yeah.

Speaker Change: Yes.

Speaker Change: [music].