Fifth Third Bancorp Q1 2023 Earnings Call Transcript

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Provided by Quartr
May 9, 2023

There are 12 speakers on the call.

Operator

Morning and welcome to the Wyomabs Therapeutics Inc. Earnings Conference Call for the Q1 of 2023. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, today's conference is being recorded.

Operator

Let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements as defined in the Private Securities the Gaitian Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, Commercialization and product distribution plans, current and future clinical and preclinical studies and our research development programs, Expectations related to the timing of the initiation and completion of regulatory submissions, regulatory and reimbursement approvals, including statements with respect to future development of other development programs, potential for Danielson Territory Expansion and Advancement of SADA, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway The sufficiency of our cash resources, guidance and expectations for 2023 and beyond and our financial performance, including our statements regarding revenues, expenses and capital expenditure requirements and other statements that are not historical facts. Because forward looking statements involve risks and uncertainties, they are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward looking statements due to a variety of factors, including those risk factors discussed in the This quarterly report on Form 10 Q for the quarter ended March 31, 2023, as filed with the SEC on May 8, 2023.

Operator

At this time, I would like to turn the conference over to Thomas Gadd, the company's Founder, Interim CEO and President. Please go ahead, sir.

Speaker 1

Thank you. Good morning, everyone, and thank you for joining us today. On the call today, we have our Chief Financial Officer, Beau Kruse our Chief Commercial Officer, Sue

Speaker 2

Smith and

Speaker 1

our Chief Medical Officer, Doctor. Vinesh Raja. Let me begin by briefly reviewing with you the highlights So our Q1. 1st and foremost, Daniela's sales continued their momentum from second half of twenty twenty two, And we are proud to report record quarterly net product revenue in Q1 2023 of $20,300,000 up 24% compared to Q4 2022. Product revenues for the quarter are higher than originally anticipated And even though the results include initial inventory stocking at WEP, which increased International sales relatively significantly to Q1 sales performance, underpinned by positive trends in number of vials sold, Both in the U.

Speaker 1

S. And internationally and the addition of significant new treatment centers allow us to increase full year 2023 Daniela's revenue guidance from the prior range of $60,000,000 to $65,000,000 to $80,000,000 to 85,000,000 This expected increase in product revenue will have an accompanying impact on our projected full year 2020 cash burn, which we now expect To be reduced to $40,000,000 to $50,000,000 from the prior guidance of $50,000,000 to $55,000,000 In January, we announced a restructuring plan, which Focused on expanding commercialization of Daniela and developing our SATA technology. The plan included a 35% reduction in force And an anticipated 28% reduction of annual operating expenses for 2023. Reflecting implementation of this plan, we Expect that our $92,600,000 in cash and cash equivalents as of March 31, 2023, When combined with anticipated Daniela revenues, should be sufficient to support our business operations as currently planned into 2026. This estimate excludes any further development of omburtumab as well as any potential business development, And Bo will talk more about that later.

Speaker 1

Lastly, we are thrilled to announce the first couple of patients have been dosed in the Phase I GD2 SADA trial. The goal of this dose escalation open label trial is to determine the recommended Phase II dose and dosing interval of protein and isotope. We believe that the SADA technology has the potential to deliver radiation precisely to a tumor antigen while minimizing Radiation toxicity of healthy tissues potentially resulting in significantly increased therapeutic indices. We are actively recruiting malignant melanoma, sarcoma and small cell lung cancer patients and are pleased to give you an update on the first couple of patients Looking at half lives or blood clearance, which Doctor. Raya will get back to.

Speaker 1

Turning to Daniela franchise. Daniela is approved by the FDA for the treatment of relapsed and refractory high risk neuroblastoma in the bone or bone marrow for patients who have demonstrated a partial response, minor response or stable disease to prior therapies. We are very pleased to see that under the leadership of Sue Smith, our Chief Commercial Officer, Our commercialization efforts are gaining momentum in the U. S. Landscape, and we are making considerable efforts To expand access to Daniela outside of the U.

Speaker 1

S, where we continue to seek partners to potentially provide access to Daniela on a global scale. As I mentioned, our Danielson net revenues in the Q1 of 2023 increased by 24% sequentially From the Q4 of 2022, primarily driven by an increase in the number of new U. S. Patients As we are seeing the positive results from a successful execution of our 2022 commercial strategy development plan, As well as an incremental benefit outside of the U. S.

Speaker 1

Where initial inventory stocking at WEP generated revenues of $2,500,000 in the first quarter. And we do not anticipate sales under this early access program to be high as high in the future quarters. We are confident that we are gaining momentum both in the U. S. And internationally.

Speaker 1

I'm very pleased to have Sue with us today on our call To provide more insights on the sources of Lendlysis growth. Over to you, Sue. Thank you.

Speaker 3

Thank you, Talendes, and good morning, everyone. I'm pleased to be with you all today, and I'm happy to have the opportunity to talk about the progress we've made. We believe the Q1 twenty twenty three revenue growth demonstrates that our strategic commercialization plan positions us well for future growth in the marketplace. Now over 2 years since launch, more and more, we believe physicians are gaining experience and seeing the benefits of Daniela. First, keeping the patient at the center of everything we do, our team has seized the opportunity to educate the market about the safe and effective use of Daniela, The Q1 of 2023 continued building upon our work in identifying and supporting new patients And our foundational rare disease approach and aligned omnichannel mix yielded the highest consistent number of patients in our hub 30.

Speaker 3

2nd, focused the team is very focused on their accounts and working as a team. With the restructuring that Thomas mentioned, the team adjusted territory alignment against refined target segments to provide laser focus on the greatest potential accounts For Daniela, for enhanced efficiency and impact. We gained 5 new accounts in Q1, including several notable centers of excellence. We have 53 accounts using Daniela's since launch with 25 of those active in Q1 alone. I am very proud of the team as they have adapted and kept their focus and it is evidence of the team's professionalism and commitment to keeping patients at the center 3rd, we continue to provide ongoing customer support.

Speaker 3

The team's customer support has resulted in a more Confident administration experience, which we believe has led to an upward trend in the number of cycles patients receive as well. It has also led to a 45% of our accounts having had 2 or more patients on Daniela since the launch in 2021. By continuing to execute on these initiatives, our mission is to ensure that Daniela can reach its full potential and help as many appropriate patients as possible. We are encouraged to see Daniela adoption and market share trending upward in the U. S.

Speaker 3

Anti GD2 market, Exiting the Q1 of 2023 and based on the number of vials sold, we estimate we now have a 17% market share I'm proud of the team and we are excited to continue building on the solid foundation that we have in place for Daniela. Thank you for your time. Back to you, Thomas.

Speaker 1

Thank you, Sue. Great. As you know, we also continue to work with MSK on its multicenter investigator sponsored osteosarcoma trial for nacitamab to potentially expand our Daniela label to new indications. In addition, we are actively recruiting patients for a new investigator sponsored study, we call the BCC-eighteen beating childhood cancer study sponsored. This multicenter Phase II trial evaluates nacitamab in combination with standard induction therapy For patients with newly diagnosed high risk neuroblastoma.

Speaker 1

The study has now initiated 5 sites, And we are working to activate additional sites, and we have dosed 3 patients so far. We believe that the potential addition of anti GD2 therapy to induction chemotherapy. To add anti GD2 therapy to induction chemotherapy early in the treatment Process may result in an improved endoplankdosing response and Dosh overall survival. Nacitamab's activity in triple negative breast cancer in preclinical study conducted by MD Anderson Cancer Center was showcased in a poster presentation at AACR in April this year. The poster showed that GD2 was up regulated in triple negative breast cancer and its high expression is associated with poor prognosis.

Speaker 1

Further, Nexinimab targets cancer stem cells and may be able to inhibit tumor growth by enhancing macrophase mediated ADCC and T cell mediated cytotoxicity. We will also be providing nacizumab for an investigator sponsored Phase 1b study planned at Ohio State University. This study will evaluate the addition of nacizumab to GEMSA and NK cells in advanced breast cancer. It is currently awaiting IRB approval. We anticipate patient recruitment to start in Q3 of this year, And we plan to provide an update at our annual R and D Day in December of this year.

Speaker 1

I believe our strategy to provide nacizumab to support Investigator sponsored studies to potentially establish proof of concept in adult indications is beginning to take shape. This approach allows us to test our drug in a controlled environment before potentially advancing to larger clinical trials. As you can hear, we are very excited about the possibilities going forward to address additional pediatric and adult unmet medical needs And thus augment the commercial opportunity of Daniela. I'm also very pleased now to have Doctor. Raja on our call today.

Speaker 1

Over to you, Vinesh.

Speaker 2

Thank you, Thomas. Good morning, everyone. Turning now to our self assembly disassembly or SADA, which is a 2 step We are now ready to take our first question from SADA. Please go ahead. Thank you.

Speaker 2

Thank you. Our next question comes from the line of SADA. Please go ahead. Thank you.

Speaker 4

Thank you. Our next question comes from

Speaker 2

the line of SADA. Please go ahead. Hi, SADA. Good morning, everyone. SADA is a key innovative platform in our portfolio that we believe continues to show great promise In the targeted delivery of radiopharmaceuticals to tumor sites with minimal off target effects, creating potential opportunities to significantly increase the therapeutic index.

Speaker 2

As we continue to optimize this technology, we become even more encouraged about the potential scientific advancement it represents SADA's differentiation stems from our 2 step infusion. We expect SADA's ability to pre target the tumor while rapidly clearing unbound protein prior to administering a DOTA caged radioisotope That can only bind to the protein sitting on the tumor to result in a significantly increased therapeutic index that we have not seen before. Furthermore, the 2 step technology makes it possible for our potential partners to use existing major treatment infusion centers Because our drug candidate is first infused as a protein only injection followed by the second step of the radioisotope injection. This unique two step method facilitates the involvement of the medical oncologists and removes the needs to send patients directly to nuclear medicine departments among other advantages. Furthermore, we have the ability to collect pharmacokinetic data by imaging.

Speaker 2

Such imaging may potentially enable us to assess tumor targeting and confirm at an early stage the feasibility of the therapeutic treatment. At this point, a total of 5 sites in the U. S. Are now open, including UPMC, the clinical trial lead site and MSK opened a few weeks ago and we have started treating patients with GD2 positive solid tumors including small cell lung cancer, I'm pleased to share with you today that we have treated the first couple of patients and we are excited to see that the blood PK profile from these patients appears to match our preclinical models in terms of clear and stater. We initially started treating patients with 120 hours or 5 day interval, but have now cleared the first cohort and the next We intend to share initial PK data later this year from this first in human Phase 1 trial.

Speaker 2

Beyond GV2, we're also pursuing a CD38 SADA program against non Hodgkin's lymphoma with an IND plan to be submitted to the FDA later this year. We aim to address the unmet need in relapsed and refractory non Hodgkin's lymphoma and in particular those of T cell origin. We believe that we are well positioned to explore potential partnership options to leverage our proprietary SADA platform, our team's expertise and a streamlined process validation. We're very excited to continue building out our Scioto franchise and I'm proud of our progress. Thank you all, and back to you, Thomas.

Speaker 1

Thank you, Ines. We continue to work efficiently to support Daniela with a global commercial footprint Through regional partnerships in multiple territories. As you know, we established a partnership with Cyclone Pharmaceuticals for Daniela expansion in Greater China. We're especially excited about the regulatory approval for marketing in China that took place in December 2022, and we look forward to the planned launch in China in Q2 2023. We believe that this market could potentially be an important revenue driver for Daniela's sales In Asia, the Q1 of 2023 demonstrated the continued progress among our other partners covering LATAM, Central Eastern Europe and Israel to support Daniela's potential and gaining access to global markets subject to regulatory approval in the relevant territories.

Speaker 1

In January 2023, we initiated restructuring in the form of a strategic repurchase station focused on Daniela and the SADA platform. It includes deprioritization of omburtumab and other early stage programs, including the CD33 bispecific And the DD2, DD3 vaccine programs. Though we continue to consider the future of our onbirgemab development program, We are focused on LANELSA and growing its on label revenue and label expansion opportunities and the development of SADA constructs With the goal of making us a commercial state biotech company with a sharper focus on value creation. As part of this restructuring, We implemented a reduction in our workforce in the Q1 of 2023 of approximately 35%, And we anticipate our revised business plan will result in a reduction in annual operating expenses of 28% for 2023, Which we expect when combined with anticipated Daniela revenues to extend our cash runway into 2026 based on our current business plan. We ended the Q1 of 2023 with $92,600,000 in cash and cash equivalents.

Speaker 1

With a strong cash runway, growing revenues and robust pipeline, we believe we are well positioned to continue our efforts to deliver further clinical And commercial milestones support the continued commercialization of Daniela and advanced our early stage programs With the revolutionary SATA technology construct, Bo Cruz, our CFO, will now elaborate on these topics in his financial update. Over to you, Bo.

Speaker 5

Thank you, Thomas, and good morning, everyone. Sanyasa net product revenues of CAD 20,300,000 in the Q1 of 2023 increased by 24% sequentially compared to the Q4 of 2022, We had revenues of $16,400,000 The increase was primarily driven by an increase in new U. S. Patients in the Q4 of 2022 And the Q1 of 2023 as we are building momentum and an incremental benefit from international net revenues. Our net product revenues from other countries in the Q1 of 2023 included $2,500,000 worth of revenues from our distribution partner in connection with the early access program for the Neosin Europe.

Speaker 5

The product revenue from this early access program generated an initial inventory stocking order of $2,500,000 which we do not expect to Moving to operating expenses. Our R and D Expenses decreased by $9,500,000 to $13,400,000 for the quarter ended March 31, 20 And 23, the decrease was primarily due to the decrease in spending on deprioritized programs, which resulted in decreased Spending for costs for outsourced manufacturing services, outsourced research and supplies and clinical trials, partially offset by an incremental increase $2,000,000 for the out of period impact for accrued severance related benefits and accelerated stock based compensation expense associated with our 1st quarter restructuring charge. SG and A expenses decreased by $1,200,000 to $12,200,000 for the 3 months ended March 31, 2023 compared to $13,400,000 for the 3 months ended March 31, 2022. The decrease in SG and A was primarily the result of decreased personnel related costs, including of stock based compensation And insurance costs. The decrease in personnel related costs is inclusive of an incremental $800,000 accelerated sub based compensation expense related to our Q1 restructuring charge.

Speaker 5

We reported a net loss for the Q1 ended March 31, 2023, of $6,400,000 or $0.15 per share basic and diluted Compared to a net loss of $28,100,000 or $0.64 per share basic and diluted for the quarter ended March 31, 2022. The significant improvement in our net loss was primarily driven by the increased Danielson revenues and decreased R and D expenses in the Q1 of 2023, partially offset by the restructuring charge. As Thomas mentioned, we ended the Q1 of 20 With cash and cash equivalents of $92,600,000 our first quarter Cash burn of $13,100,000 was 31% below the 2022 quarterly average. We believe that our cash position is sufficient to fund our operations as currently planned into 2026 And provides a solid financial runway to support our commercial initiatives and our prioritized pipeline programs as currently planned. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand.

Speaker 5

No new partnerships or other new BD income is included in the assumptions. The Daniilte product revenues are assumed to increase 10% easier in 2024 and 2025 for the purpose of this analysis of runway. We hope to see a higher growth rate for Taneza as we execute our refined commercial strategy and work to deliver clinical data that could In terms of development activities, we have assumed that our Prioritized programs will be advanced at our own expense and no new programs are assumed at this point for the purpose of the analysis. This financial runway forecast benefits from the fact that most of the expenses related to the pivotal trials, Post marketing commitments, regulatory activities and the restructuring are behind us at this point. For the purpose of the guidance, we have not assumed any equity of debt offerings over the borrowings.

Speaker 5

As Thomas mentioned earlier, We are very pleased to announce that we are updating our financial guidance and we now anticipate full year 2023 Danielson net product revenues guidance to be in the range of $80,000,000 to $85,000,000 and we are now decreasing our projected cash burn to $40,000,000 to $50,000,000 for the full year 2023. As previously disclosed, we continue to expect operating expenses of $115,000,000 to $120,000,000 We believe Ymabs remains in a healthy financial position To execute our strategic mission, our priorities and to support the delivery of multiple milestones. This concludes the financial update. And I'll now turn the call back to Thomas. Okay.

Speaker 1

Thank you very much, Bo. So this

Operator

Ladies and gentlemen, we will now begin the question and answer session. First question comes from Alex Janahan at Bank of America. Please go ahead.

Speaker 4

Hey, guys. Good morning. This is John on for Alex. Congrats on the sales number for Danielle's 24% sequential increase. For 2023, are we looking at so what Are we looking at maybe a future inflection point that we can meet?

Speaker 4

For example, maybe ex U. S. China sales adding to top line, is that a possibility? Second question on SADA Recruitment, in terms of patient recruitment for SADA, you did mention, I think, 3 tumor types, myeloma And non small cell lung, any specific metrics you're looking at when you're recruiting patients, mutation you're screening for, Absence the mutations you're screening for? Any color on that would be appreciated.

Speaker 4

Thanks.

Speaker 1

All right. Thank you. So the first one, yes, we are very excited about the launch in China to happen this year and we do think that that will add to our ex U. S. Sales and they should launch here in the second half any day now.

Speaker 1

So we do think that will contribute to our sales. On the second question, I would leave that over to you, Vinesh.

Speaker 2

Yes. Thank you. Well, The tumors that we are looking at is small cell lung cancer, melanoma and sarcomas. So for each of these patient groups, we are looking Those who have failed first line therapy or in second line, third line therapy, I don't have the details of specific types of markers We're looking at in the specific indications, but they are all very much in the relapsedrefractory setting.

Speaker 4

Okay. Thanks.

Operator

Thank you. The next question comes from Bill Maughan at Canaccord Genuity. Please go ahead.

Speaker 6

Good morning and thanks. So on the Daniela growth, I was just looking for any additional commentary on the types of patients that are being enrolled. I know You previously talked about if you can get into patients earlier in the treatment paradigm, you could potentially that would lead to More vials per patient, more treatments per patient. I'm just wondering if you have a sense that you're seeing that dynamic happen. Also on Daniela, I know you said $2,500,000 in stocking.

Speaker 6

Is that entirely stocking or is there any underlying Patient demand in Europe that drove that number. And I'll have a follow-up after that.

Speaker 1

Thanks. Sue, you can take the first question.

Speaker 3

Okay. Thanks. Yes, Bill, I think we are seeing a slight trend towards the patient types. When you see the patient who has failed induction therapy and they're receiving bridge therapy, so there is a bit of a change. It's very slow, but we're doing more to support that with training our field team around patient identification And working on those conversations with customers, I think that the main part of the growth has really come from Seeing, it's a combination of having a solid foundation plus growth in breadth and depth.

Speaker 3

So it's a number of things. But yes, to your point, one of the dynamics is a slight trend of seeing some more of those earlier patients.

Speaker 1

Vinesh, do you want to give an update on WEP?

Speaker 2

Yes. So this is a main patient program for Europe that we launched earlier this year. We have a number of Requested patients who are undergoing screening and anticipated treatment with naxitamab. Primarily, these are going to be in one center in Barcelona. So this is ongoing at the moment.

Speaker 2

So far, we believe there are 3 to 5 patients That are about to be treated.

Speaker 6

Okay, thanks. And just looking further out, I know You reiterated 1Q 'twenty six for cash runway, but that's despite an improving Daniela's growth trajectory. At only a $6,400,000 net loss this quarter, at some point you approach cash flow positivity. So do you Is that something that's in the horizon? Or as you approach that, do you feel that you could use your cash balance to spend on other Programs that might be deprioritized right now.

Speaker 6

I'm just trying to balance the financial aspect of cash flow positivity versus Growth from the R and D.

Speaker 1

Yes, thanks. So I think at this point, we are staying disciplined on R and D In order to validate SADA and GD2, and then obviously, our strategy is to go out and see potential Multi Target Drug Development Partnerships. But of course, if we turn up R and D, breakeven Goes on the horizon, but at this point, we are staying very disciplined and very focused on our strategy.

Speaker 7

Maybe just one on the GD2 SADA program. You mentioned it starting at a dosing interval about 5 days, I believe, and you've cleared that and now you're at 48 hours. Is the target there for an interval of 48 hours or could you potentially shorten that as well? Thanks.

Speaker 1

So Vinesh, I'll just so the our preclinical data shows 48 hours to be the optimal interval. But I'd let you add to that, Manesh.

Speaker 2

Yes. I think as Thomas says, all our murine mass models and the PK data Suggests that majority of the GD2SATA protein is cleared from the plasma around 48 hour mark, And we expect that to be a similar picture for our human clinical data as well. And that's pretty much what we have seen in First initial data from the first patient, we're seeing a very similar clearance of 48 hours, 50 hours by which The GD2SARO serum concentrations are virtually cleared from the blood. So we don't anticipate To go any lower than that, just based on the shape of the curve, you'll recall that one of the Key elements of maintaining a high therapeutic index is to ensure that we minimize The amount of startup protein, unbound protein in the plasma. So I think that's the trade off we need to make as to ensure we Maximize on the narrow PK window where we allow for a plasma half life just long enough to reach the tumor, But short enough to almost completely be removed from the blood before the payload administration.

Speaker 2

So short answer to your question is, We don't expect it to go below 48 hours in terms of interval, but we believe this will probably be the most optimal interval.

Speaker 7

Got it. And then maybe just one quick follow-up. As you dose escalate, will you be starting at the 48 hour interval? Or do you need to test A longer interval initially as you dose escalate. Thanks.

Speaker 1

We'll then move on at the 40. Yes, go ahead. Okay.

Speaker 2

We'll remain under 48 hours. So at the moment based on the PK data, we will remain at 48 hours based on the optimal clearance and the half life that we've seen from that. So we don't anticipate changing that.

Speaker 5

Got it. Thank you.

Operator

Thank you. The next question comes from Charles Zhu at Guggenheim Securities. Please go ahead.

Speaker 8

Hey, yes. Good morning and thanks for taking the questions. Maybe just a couple more follow ups on the GD2 SADA. First of all, it sounds You've really been speeding up enrollment on that front. But also just regarding the how are you guys Thinking about additional dose escalation on the protein side, it sounds like you're narrowing down the dosing interval, but how should we

Speaker 2

So if I understood your question correctly, the SADA protein dose administered for this 1st cohort was at 0.3 milligrams per kilo for these first two patients. And we have now passed that first cohort We are now moving on to the 2nd cohort, which will still remain at the same dose level of 0.3 milligrams per kilo, But with a shortened interval of 2 days. The next cohort level, the 3rd cohort level will be increased to 1 milligram per kilo. Subsequent to that, it will be 3 milligrams per kilo and then the final Cohort 5 will be up to 10 milligrams per kilo. So we anticipate, we expect a similar PK picture in all of these situations where the clearance of the SADA protein from the plasma We'll mimic the pattern we've seen earlier, which is 48 hours being the optimal interval.

Speaker 2

So that's the kind of concentration or dosage we anticipate to give. Sounds good question.

Speaker 8

Got it. Great. Yes, thanks for that. And maybe just one quick follow-up. I'm not so sure if I missed this one earlier in your remarks are on earlier Q and A, but I guess just based on some of your earlier your early experience with the first cohort so far, when might You expect to be able to administer the therapeutic dose of Lulutetium for GD2 SADA.

Speaker 8

And is this something that could potentially happen? And Could we have line of sight into that data whenever you present your initial clinical update? Thanks.

Speaker 2

So in order for patients to receive that therapeutic dose, of course, we need Evidence of tumor targeting through the images and in these first two patients, we weren't able to get image of So they would not have received a therapeutic dose. But had they shown tumor targeting on the image, they would have received Similar dose of PASADO protein on day 15 followed by 2 days later or 5 days later The therapeutic dose of 200 millicuries of lutetium dota. So that would have been a logical step if they had evidence of imaging on the scans. Great. Thanks for taking the questions.

Operator

Okay. Thank you. Next question comes from Tessa Marrow at JPMorgan, please go ahead.

Speaker 9

Good morning, guys. Thanks so much for taking our questions. So just Two commercial ones for me. So the first one is, can you walk us specifically through What metric or dynamic gave you the most conviction to raise your guidance here? And what portion of the net revenues within your updated guidance range do you expect to be international And then I had one quick follow-up.

Speaker 1

Bo, do you want to take that?

Speaker 5

Yes, I'll be happy to. So essentially, what we're seeing is a nice growth across the board. We are, of course, monitoring the U. S. Sales very closely.

Speaker 5

We've seen more than 20% increase in the number of Avios sold from the Q4 last year to the Q1 of this year, which is even better than what we saw from the Q3 to the Q4 last year. So we're monitoring this development very closely. Internationally, there's also Solid growth, I would say. You saw that for 2022, we had about 6% of the Overall revenues coming from international sales, and we do expect this to increase in

Speaker 4

So

Speaker 5

from the Q4 last year to the Q1 this year, we've seen An increase of about 6% when we clean up that WEP revenue. So even though none of the countries have really launched internationally, it's still a nice ramp up of the revenues. And to answer the first part of your question, We would expect U. S. Revenues to be in the mid-70s and international to be $5,000,000 to $8,000,000

Speaker 9

Okay. And just a quick follow-up. Thanks, Paul. That was helpful. I think Sue alluded to this in some of her earlier How are no patients treated on average with Daniela?

Speaker 9

And what are you hearing in your market research on Any like recent dynamics around Danielle's and Unituxan?

Speaker 3

I can take that, Tessa. So in terms of the dynamics With dinutuximab, we are essentially slowly cannibalizing dinutuximab Quarter over quarter, with a growth in GD2 market share. And, predominantly, I think there this is really because Doctors and caregivers are just seeing that Daniela is a good product. Our account is very focused on where the business is and We're consistently adding new customers from a breadth standpoint with in the Q1, we have 19 patients outside of Sloan Kettering. We also from a depth standpoint saw a significant increase from Q3 2022 last year to Q1 in this year Nearly half of our new customers with 2 or more patients.

Speaker 3

So they're getting more confidence and they're starting to Now have multiple patients on. So I think slowly those are what are contributing to our gaining more confidence in the market As a GD2 of choice.

Speaker 9

Okay. And how long are patients treated on average?

Speaker 3

Our average number of cycles is about 4 With a range from 1 to 8 roughly.

Speaker 9

Thank you.

Operator

Thank you. Your next question comes from David Nierengarten at Wedbush Securities. Please go ahead.

Speaker 10

Hey, thanks for taking the question. I had one on SADA in lymphoma. I was just wondering if there's anything that You saw our point us to on the blood cancer side that would support use or scientifically what's the rationale

Speaker 1

Go ahead, Vinesh?

Speaker 2

Yes. Well, the Sandeep rationale is AIM of the fact that number of hematological malignancies expressed are well known to express CD38. So our focus is on the non Hodgkin's lymphoma. We know that B cell lymphoma Has had a number of therapies that's shown to be effective, but there's more of an unmet need in T cell lymphoma. So we are looking at expanding our development in this particular indication.

Speaker 2

CD30 has obviously expressed in other tumors such as But this is the initial tumor indication that we want to expand.

Speaker 10

Sorry, just a follow-up. I mean, there's been a lot of challenges developing radiation and Therapies in liquid tumors because of side effects, myelosuppression, things like that. Are there EOX or other characteristics that you've seen that Help you to avoid that. Is it just the fast clear? Is it something else about the technology that's important to differentiate and Supports its use in lymphoma setting.

Speaker 2

Yes. I think that where we anticipate CD38 SADA to differentiate itself from other current therapies or investigational therapies Precisely what you just said is in the safety aspects and the therapeutic index from the clearance profile. And we believe that The uptake from the tumor, removing the CD38 from the circulation because it rapidly disassembles in the serum, Therefore, allowing when we do administer the radio hyper payload for minimal systemic circulation of radio iStope and therefore Systemic side effects, we think this could potentially be a game changer as far as therapeutic index. So I think this is where So we see this adding to the armamentarium of physicians managing these patients who may not always have ideal performance status in this group.

Speaker 1

Thanks.

Operator

Thank you. And the next question comes from Sebastian S. At VLK. Please go ahead.

Speaker 11

Hi, team. Congrats on the excellent sales and thank you for taking my questions. The first question is on Daniel's. I was just wondering, Sue, if you can maybe give a breakdown on the numbers of centers that actually treat patients on a more consistent basis versus those that are Chorically treating patients, I want just to get some insight on to how the market has been growing for you guys.

Speaker 3

Sure, Sebastian. So as you can imagine, as we've seen the growth occurring, While our vial sales and our patients are increasing, because the accounts that we have in place are treating More than 2 patients, the number of accounts, it does not need to increase quite so commensurate with the vial sales. So essentially what we look we are adding an average of about 5 new accounts per quarter with a range of 2 to 9. And we currently have 53 customers treating. At any given time in our hub, we are now averaging about 30 active patients who are either in treatment or getting their insurance coverage approved for treatment.

Speaker 3

And so in the Q1, we saw that basically half of our current accounts are actively treating So in the Q1, we had about 27 accounts With new customers receiving a shipment in the Q1. And so they're smaller numbers, obviously, Because we're looking at an ultra rare indication, but the growth that we're seeing is predominantly Ex MSK, where we really grew our volume of sales We are over 150 percent of our internal goal for ex MSK growth. So that's Like I was saying before, I think the growth that we're seeing is a healthy combination of the patient finding work the team is doing. And it's spread out well over the country and growing in the depth in the number of patients per account. So in Q1, we had 19 patients outside of MSK in Q1 that were a new start, 19 new patients.

Speaker 11

Okay. Got it. Thank you so much. And then on SADA, I just was wondering, you mentioned that you did not see tumor targeting with the first dose cohort. Based on your preclinical work, can you say something on when you do expect to see actually tumor targeting?

Speaker 1

Thanks. I'm not sure if we can I mean, definitely 0.3 milligram is obviously Expect to be too low, but should it be 1 or 3? I mean, you know we dose 3 milligram with our IgG. So, but Vinesh, do you want to add to that?

Speaker 2

Yes. It's another easy question to answer, when would you expect it? But I think the likeliest explanation for why we've not Seeing this is the very low starting dose of either the solid protein and also potentially the radioactivity of So there is provision within our study design to increase that from 30 millicuries to 90 millicuries If there are a certain number of patients who are not able to show this imaging capture. So almost certainly, It's the dose that's contributing to perhaps not this being picked up at this stage, but we anticipate that obviously As we escalate to higher doses, we anticipate this to show up much more predictably.

Speaker 11

Okay, got it. Thank you so much.

Operator

Thank you. At this point, it seems there are no further questions. I'll turn the call back over to Thomas Gadd for closing remarks.

Speaker 1

Thank you. Thank you everyone for your questions and Thanks for joining us and have a great day.

Operator

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and we ask that you please disconnect

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Earnings Conference Call
Fifth Third Bancorp Q1 2023
00:00 / 00:00