Q1 2022 Y-mAbs Therapeutics Inc Earnings Call
[music].
Yeah.
Good day and welcome to the Y M. EPS Therapeutics, Inc. Earnings Conference call. The first quarter of 2022 today's conference is being recorded.
Operator: Good day and welcome to the Y-mABS Therapeutics Inc. Earnings Conference Call for the first quarter of 2022. Today's conference is being recorded. Let me quickly remind you that the following discussion contains certain forward-looking statements that are considered forward-looking statements, as defined in the Private Security Litigation Reform Act of 1995. 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 company's annual report on the Form 10-K for the fiscal year ended December 31, 2021, as filed with the FEC on March 1, 2021. At this time, I would now like to turn the conference over to Thomas Gad, the company's founder, interim CEO, and president. Please go ahead, sir.
Quickly remind you that the following discussion contains certain forward looking statements that are considered forward looking statements is defined in the private Securities Litigation Reform Act.
1995, because forward looking statements involve risks and uncertainties 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.
Those risk factors discussed in the company's annual report on Form 10-K for the fiscal year ended December 31, 2021.
Files with the SEC on March five 2022.
At this time I would now like to turn the conference over to Thomas Gad.
The company founded interim CEO and President. Please go ahead Sir.
Thank you good morning, everybody and thank you for joining us today.
Thomas Gad: Thank you. Good morning, everybody, and thank you for joining us today. I'm very pleased to briefly review our accomplishment in the first quarter. We saw a great start to 2022, with excellent progress on our key programs, notably the resubmission of your BLA from Bertramat. Thank you very much, and the advancement of the SARLA technology platform with.., with the data recently presented at AACR in April. We expect 2022 to be yet another transformative year for YMAP. As we announced last week, Klaus Müller has stepped down from his position as Chief Executive Officer.
I'm very pleased to briefly review our accomplishment in the first quarter.
We saw a great start to 2022.
With excellent progress on our key programs are notably the Resubmission of <unk>.
P L a small embarrass him up.
In Q1 as promised we had a 9% sequential increase in net revenues, but then you also.
And the advancement of the Sada technology platform.
But the data recently presented at ACR in April .
We expect 'twenty to 'twenty two to be yet another transformative year for why maps.
As we announced last week, Klaus Miller, who stepped down from his position as Chief Executive Officer.
Thomas Gad: The company made considerable progress under his leadership and we are grateful for his contributions and wish him all the best in his future endeavors. I've assumed the role as Interim CEO, while the search is ongoing for a new Chief Executive Officer, and today I'm joined on the call by Bo Kruse, our CFO, Sue Smith, our Chief Commercial Officer, Vignesh Rajah, our Chief Medical Officer, and Dr. Steen Lisby, our Chief Scientific Officer. All of us here at Y-mAbs are truly proud of two of our Danielle's children who have experienced multiple relapses from high-risk neuroblastoma in the bone or bone marrow, or who did not respond to previous treatment.
The company made considerable progress under his leadership and we are grateful for his contributions and wish him all the best in his future endeavors.
I have assumed the role as interim CEO , while the search is ongoing for a new Chief Executive Officer and today I'm joined on the call by Bo Kruse, All CFO Sue Smith, our Chief commercial officer.
It's Ryan our Chief Medical Officer on doctors in this view, our Chief Scientific officer.
All of US all of US are truly proud of to offer Danielle says children, who have experienced multiple relapses from high risk neuroblastoma in the bone the bone marrow or who did not respond to previous treatment.
And yes. It is our first commercial product and was launched 15 months ago. After the Fda's accelerated approval.
Thomas Gad: Danielle's is our first commercial product and was launched 15 months ago after the FDA's accelerated approval for the treatment of patients with relapsed and refractory iris nobustoma, in the bone and bone marrow who have demonstrated a partial response or stable disease to prior therapy. Our Chief Commercial Officer, Sue Smith, who joins us at the start of the year, is already leveraging her rare disease experience to highlight and differentiate Danielse in the U.S. and other markets. She has implemented several positive changes to our approach, and I'm very pleased to have Sue on the call today, and we'll now hand it over to her. Go ahead, Sue.
But the treatment of patients with relapsed and refractory high risk neuroblastoma.
In the bone the bone marrow with demonstrated a partial response or stable disease to prior therapy.
Our Chief commercial Officer, Sue Smith, who joins us at the start of the year.
It's already leveraging her rare disease experience to highlight and differentiate then Nielsen the U S and other markets.
He has implemented several positive changes to our approach and I'm very pleased to have you on the call today, and we'll now hand it over to her.
That's true.
Thank you Thomas Good morning, I'm pleased to be with you all today and happy to have the opportunity to talk about some of them can your strategies and processes put into place to drive our new growth opportunities and also to mitigate barriers to entry during the first quarter based on valuable key learnings from our first launch market.
Sue Smith: Thank you, Thomas. Good morning. I'm pleased to be with you all today and happy to have the opportunity to talk about some of the new strategies and processes put into place to drive our new growth opportunities and also to mitigate barriers to entry. During the first quarter, based on valuable key learnings from our post-launch market experience, we've developed a roadmap to further focus our efforts along the full pediatric neuroblastoma patient journey. This includes identifying and supporting patients at all community hospitals and not just relying on the academic institutions.
We've developed a roadmap to further focus our efforts on the full pediatric neuroblastoma patient journey.
This includes identifying and supporting patient community.
Community hospitals, not just relying on the academic institutions or commercial plan consists of three pillars first we are maintaining and growing the existing business, we'd been enriching our account management team support formulary inclusion focus and peer to peer engagement with more than half of our accounts.
Sue Smith: Our commercial plan consists of three parts. First, we are maintaining and growing the existing business. We've been enriching our account management team support, formula inclusion focus, and peer-to-peer engagement. With more than half of our accounts now having experience with multiple patients, we're also growing our network of key opinion leaders to help with education. Second, we're filling the funnel.
Now having experience with multiple patients. We're also growing our network of key opinion leaders to help with education.
Second we're filling the funnel.
Sue Smith: The team is now using claims data to identify customers with active patients and understand where they are in their journey. This allows us to improve our targeting and provide our account managers with real-time leads for the first time. This allows us to engage with customers with relevant patients and drive the appropriate use of Danielza earlier in their journey. And third, we have very clear goals and are aligning team recognition to those goals.
Team is now using claims data to identify customers with active patients and understand where they are in their journey. This allows us to improve our targeting and provider account managers with real time leads for the first time it's.
This allows us to engage with customers with relevant patients and drive the appropriate use of Daniels are earlier in their journey.
And third we have a very clear goals and are aligning team recognition to those goals.
Sue Smith: I've worked with the commercial leadership team to create and operationalize a new strategic roadmap based on the levers I mentioned, and we have aligned all commercial team activities to these goals, including incentive compensation, awards, and recognition for success. Our refined approach appears to show early signs of working, as we recorded Danielle's net sales of $10.5 million for the first quarter, a 9% increase from the previous quarter. We're also encouraged by the increase in the number of treatment centers that have gained experience with Danielza, with 34 treatment centers now having administered Danielza across the nation, up 21 percent compared to 28 centers by the end of last year. Approximately 50% of the vials sold in the U.S. are now sold outside of Memorial Sloan-Kettering or MSK.
With the commercial leadership team to create and operationalize, our new strategic roadmap based on the levers I mentioned and we have aligned all commercial team activities to these schools, including incentive compensation awards and recognition for success.
Our refined approach appears to show early signs of working as we recorded Daniels in net sales was $2 5 million for the first quarter and 9% increase from the previous quarter.
We're also encouraged by the increase in the number of treatment centers and have gained experience with Nielsen with 34 treatment centers now having administered daniels than across the nation up 21% compared to 20 centers by the end of last year.
Approximately 50% of the milestone in the U S are now sold outside of Memorial Sloan Kettering or M. S. K.
Sue Smith: This is a notable increase, since only approximately 40% of the vials were sold outside of MSK in prior quarters. We continue to be very focused on the Daniella launch and are pleased with the traction we're getting in the market at this point. Accordingly, we've recently made the decision to increase our field sales headcount by about 20%. We have reported five consecutive quarters of growth, and we believe we have now gained a fundamental understanding of the market penetration patterns. The first quarter revenue of $10.5 million is a notch above our internal expectations, and we now expect total product full-year revenues for 2022 to be between $45 and $50 million.
This is a notable increase since only approximately 40% of the vials were sold outside of M. S. K in prior quarters, we continue to be very focused on the Daniels our lunch and are pleased with the traction we're getting in the market at this point Accordingly, we've recently made the decision to increase our field sales head count by about 20%.
<unk>.
We have reported five consecutive quarters of growth and we believe we have now gained a fundamental understanding of the market penetration patterns. The first quarter revenue of $10 5 million is a notch above our internal expectations and we now expect total product full year revenues for 2022 to be between <unk> 25.
And $50 million.
A year into the launch the team continues to drive daniels's adoption and we're very encouraged by its benefits over the other currently available options, including rapid infusion fewer hospitalization days and in an outpatient setting.
Sue Smith: A year into the launch, the team continues to drive Danielle's adoption and we're very encouraged by its benefits over the other currently available options, including rapid infusion, fewer hospitalization days, and in an outpatient setting. We are squarely focused on expediting Danielza's adoption, and we are continuing its development in expanded indications. So to summarize, we are optimistic about the long-term opportunity for Danielza as underscored by clinicians' feedback. Our focus remains on continued accelerated adoption, and looking ahead, we plan to conduct additional medical education training to further broaden site activations. Thank you, Sue.
We are squarely focused on expediting daniels's adoption.
We are continuing its development and expanded indications so to summarize we are optimistic about the long term opportunity for Daniel Zhang as underscored by clinicians feedback our focus remains on continued accelerated adoption and looking ahead, we plan to conduct additional medical education and training to further broaden side.
Activates.
Okay.
Thank you Sue.
Thomas Gad: Going on, on Danielsa, we're also very focused on introducing Danielsa into larger adult indications and have started ongoing partnership discussions to address this opportunity. As you can hear, we're very excited about the possibilities of Danyelzer going forward. Staying very focused on the continued commercial opportunity that NILSA provides as a drug, growing top-line revenue while capturing additional pediatric unmet medical needs as we've, focus on larger adult indications as DD2 remains a well-defined target. Moving on to on birth through MAP.
Going on I'm Danielle. So we also are very focused on introducing Danielle signs. So lots of adult indications and have started ongoing partnership discussions to address this opportunity.
As you can hear we're very excited about the possibilities of 10 yards that going forward.
Staying very focused on the continued commercial opportunities in Dallas that provides us a drug growing top line revenue, while capturing additional pediatric unmet medical needs as we've.
Focus on lots of at all indications SGD two remains a well defined target.
Moving on to embark on a map.
We are thrilled with our recent resubmission of the Emirates My P. L. A.
Thomas Gad: We are thrilled with our recent resubmission of Liam Birdsmith's BLA for the treatment of CNS lepsingin metastasis from neuroblastoma. As you might recall, we had a pre-BLA meeting with the FDA in January of this year and confirmed our path towards a March BLA resubmission, which we ultimately achieved. We are hopeful that ombudsman will be approved given the meaningful improvements in overall survival rates, which data has significantly matured with time, and in view of the fact that there are no FDA-approved therapies, for this indication, addressing an unmet medical need for high-risk nervous stoma patients. Developing Siena's Metastasis.
Treatment of CNS that someone's got Mr Metastases from neuroblastoma.
As you might recall, we have a pre BLA meeting with the FDA in January of this year and confirm our path.
What's a march BLA resubmission.
Which we ultimately achieved.
We are hopeful that <unk> will be approved given the meaningful improvements in overall survival rates, which data have significantly matured with time.
And in view of the fact that there is no FDA approved therapies.
But this indication addressing an unmet medical need for high risk neuroblastoma patients.
Eloping CNS metastasis, we look forward to shank this important data in the future with you.
Thomas Gad: We look forward to sharing this important data in the near future with you. We believe that if approved on BirdsMap, it will fit well into our existing commercial infrastructure. Susan Yeltsin, and enable us to further leverage our commercial infrastructure without any major additional investment.
We believe that if approved on birdsmouth will fit well into our existing commercial infrastructure.
Uh huh.
She was on Delta and enable us to further leverage our commercial infrastructure without any major additional investments.
Thomas Gad: Additionally, we believe that ombudsman will mature into an important drug with significant label expansion opportunities over several unmet medical needs within pediatric rare diseases and also present a larger indication opportunity as B783 is a widely expressed target. As Lombardo has been granted a rare pediatric disease designation by the FDA, we are eligible to receive a priority review voucher from the agency. As you recall, we previously received a POV for Linielsen's approval and subsequently sold that POV for $105 million.
Additionally, we believe that a birthmark will mature into unimportant drug with significant label expansion opportunities over several unmet medical needs within pediatric rare diseases and also present, a larger indication opportunity SB 783 is a widely expressed target.
As embarrassment, but has been granted a rapid ethic disease designation by the FDA agree eligible to receive a priority review voucher from the agency if a person is approved.
Excuse me as you recall, we previously received the peer V. Portland, Yes, its approval and subsequently sold at three of your $405 million.
Thomas Gad: Last year, on to our lives, agreement with MSK, they received 40% of the net proceeds generated from the sale of the first PRV. And MSK is entitled to receive 33% of the net proceeds generated from the Ombudsman PRV sale, potentially securing a solid non-dilutive cash contribution to the company that will further extend our cash run. Moving on to SATA.
Last year.
Under our licensing agreement with M. S. K. They received 40% of the net proceeds generated from the sale of the first JV and M. S. K is entitled to receive 33% of the net proceeds generated from the Albertson about P. O V sale potentially securing a solid non dilutive cash contribution to the company.
We will further extend our cash runway.
Moving onto Sada, turning to a sada technology Sada as a key platform in our biomass portfolio.
Thomas Gad: Turning to our SATA technology, SATA is a key platform in the Y-mAps portfolio, that continues to show great promise in unlocking the potential for pre-targeted radiopharmaceutical which precisely target multiple tumors. As we continue to optimize the technology, we become even more encouraged about the scientific advancement it represents for the company and the medical community. The IND for our first SATA construct, a DD2 SATA, for DD2-positive salted tumors, was filed last year.
That continues to show great promise and unlocking the potential for pre targeted radiopharmaceuticals, which precisely target multiple tumors as we continue to optimize the technology, we've become even more encouraged about the scientific advancement. It represents for the company and the medical community.
The R&D fall first Sada construct D D. Two sada for TD to positive solid tumors was filed last year.
We have made great process.
Thomas Gad: We have made great progress. Progress on the IND and expect to treat the first patients during the third or fourth quarter this year. We are focused on a two-prone strategy here, treating adults in small cell lung cancer, a large indication validating DD2-SARA, while we work on our well-known pediatrics. Two positive tumors.
Progress on the I N D unexpected treat the first patients during the third or fourth quarter. This year.
We are focused on a two pronged strategy here treating adults in small cell lung cancer, a lots of indications validating TD to sada, while we work on a well known pediatric.
T D two positive tumors.
Thomas Gad: Remember, our strategy here is to out-license large applications, while we focus on unmet medical needs. Pediatric Indications, Building Our Rare Pediatric Disease Portfolio. We presented preclinical data for our GD2-SARTA construct at the AACI Annual Meeting, in April of this year. As demonstrated in the post- or pre-clinical models have shown that the trimeric state of SATA, have a stronger binding affinity and anti-tumor effects compared to the monomer state.
Remember our strategy is to out license larger indications.
We focused on unmet medical need.
Pediatric indications building, our rare pediatric disease portfolio.
We presented preclinical data for Gd to Sada construct at the ACR annual meeting.
In April 20 of this year.
As demonstrated in the post of preclinical models have shown that the American state of Sada.
Have a stronger binding affinity and antitumor effects compared to the monomer state.
Data further confirmed that the startle domain seems to significantly increase uptake.
Thomas Gad: Data further confirmed that the startle domain seems to significantly increase uptake and is persistent in tumor tissue in vivo with anti-tumor activity lasting over 100 days after treatment. We are well-positioned to explore partnership options to leverage the SADA platform in the coming months. We are working on several targets that address both pediatric and medical needs, while also addressing large... Indications fitting into our partnership strategy. We are truly excited about the potential of Stata Technology, also in terms of its ability to potentially optimize and repurpose failed Phase III targets that have already been proven safely in humans by making a SATA construct based on these topics.
And as persistent in tumor tissue in vivo antitumor activity lasting over 100 days after treatment.
We are well positioned to explore partnerships options to leverage the sada platform in the coming months.
We are working on several targets that address both pediatric unmet medical needs, while also addressing a lot into.
Indications fitting into our partnership strategy.
We are truly excited about the potential upside of the technology.
So in terms of its ability ability to potentially optimize and repurpose fail.
Phase three targets that have already been proven.
Safely in humans by making a sada construct based on Destocking.
So auto targets could potentially significantly enhance therapeutic index as evident by the cheap PK attributes of the Sada platform further unlocking the potential of pretax radiopharmaceuticals and.
Thomas Gad: SATA targets could potentially significantly enhance therapeutic index as evident by the key PK attributes of the SATA plasma, further unlocking the potential of pre-targeted radiopharmaceuticals in tumors that have not historically demonstrated meaningful responses to therapeutic agents. Now moving on to the white bike loan class. The IND file CD33 bispecific for pediatric AML has been cleared, and we believe this promising treatment can potentially address an important pediatric unmet medical need. As AML remains one of the most challenging hematological malignancies for children.
In two months that have not historically demonstrated meaningful responses to therapeutic agents.
Yeah.
I'm moving on to the white box on platform.
G I N D. A C. D 33 by specific pediatric AML has been clear and we believe this is this promising treatment can potentially address an important pediatric unmet medical need.
S. A M. L remains one of the most challenging him it's outgrown that Lincoln sees for children.
Thomas Gad: We expect to dose the first patients over the summer. We have de-prioritized NIVA Trultamap, our DD2-CD3 bispecific program, as we want to focus on the future potential of both Danielsa as a DD2 monotherapy, Addressing large adult indications, as well as the GD2 SATA being disclosed to the clinic, going into small cell, lung cancer, and other GD2-positive solid tumors. This will enable us to more efficiently utilize our financial capital to realize our full commercial potential and extend our financial runways.
We expect to dose the first patients over the summer.
We have D prioritize NEVA truths about our G D to C suite Bispecific program as we want to focus on the future potential of boats and the outside as a G. D. Two monotherapy addressed.
Addressing large at all indications as well as the G. Two sada being this close to the clinic flowing into small cell lung.
Oh in cancer and other TD to positive solid tumors. This will enable us to more efficiently utilize our financial capital to realize.
Our full commercial potential and extend our financial runway.
As you know we have a partnership with cycling on thousands of Columbus Circle, Fulton Yeltsin and abroad snap in greater China.
Thomas Gad: As you know, we have a partnership with Cyclone Pharmaceuticals for Danielsa and on BirdSmart in Greater China. We are especially excited about... Danielsa, and the potential near-term approval, to take place late this summer in China, which will trigger a regulatory milestone. We have continued to see an uptick in patients treated in the pilot zone in China and expect this market to be an important revenue driver for Danielsa's Asian sale. We continue to work on making sure that the Alzheimer's Embryo Map, if approved, will have global commercial footprint.
Especially excited about.
Then the ulcer and the potential near term approval.
Let's take place late this summer in China, which will trigger a regulatory milestone we.
We are continuing to see an uptick in patients treated in the pilots one in China and expect this market to be unimportant revenue driver for Danielle cessation cells.
We continue to work on making sure Danielle It's Adam Berlin about if approved will have global commercial footprint.
And we have additional partnerships covering Latam central Eastern Europe and Israel.
Thomas Gad: And we have additional partnerships covering LATAM, Central Eastern Europe, and the, We ended the quarter with $156.7 million in cash, and as you can see, we have tightened the belt by prioritizing our pipeline in order to be able to unlock near-term value by leveraging our pipeline through focused internal execution and by external partners, with a strong cash runway and a robust pipeline. We are on track to deliver many more clinical and commercial milestones, support the continued commercialization of Danielsen and the potential launch of Ombudsman, as well as advance our early stage programs, including the SARA Technology Conference.
We ended the quarter with $156 7 million in cash and as you can see we have tightened the belt.
Prioritizing our pipeline in order to be able to unlock near term value by levering leveraging our pipeline through focused internal execution and by external partnerships.
With a strong cash runway and our robust pipeline.
On track to deliver many more clinical and commercial milestones.
Support the continuous commercialization of Nielsen and the potential launch of <unk>.
As well as advance our early stage programs, including the Sada technology construct.
Thomas Gad: We are very pleased with our current financial position, which Bo Kruse, our Chief Financial Officer, will elaborate on in a minute. Thank you. Let me now turn it over to Bo. Thank you, Thomas. We reported Danielsa Net Product Revenues of $10.5 million for the first quarter of sales this year, which corresponds to a 9% increase from the fourth quarter of 2021.
We're pleased with our current financial position, which folks who's our chief financial Officer will elaborate on in a minute.
Thank you.
Let me now turn it over to Bob.
Yes.
Thank you Thomas.
We reported Danielle.
Product revenue was up seven and a half million for the first quarter of sales this year, which corresponds to a 9% increase from the fourth quarter of 'twenty one.
We experienced a year on year net product revenue growth of 94% compared to the.
Bo Kruse: We experienced a year-on-year net product revenue growth of 94% compared to the 5.4 million reported for the first quarter of 2021, when the first 10 years of vials were delivered. As we take a closer look at the operating expenses for the first quarter of 2022, we note that research and development expenses increased by $1.3 million from $21.6 million for the quarter ended March 31, 2021, to $22.9 million for the quarter ended March 31, 2022.
$5 4 million reported for the first quarter of 2021 when the first stimulus Abbas were delivered.
Let's take a closer look at the operating expenses for the first quarter of 'twenty 'twenty. Two we note that research and development expenses increased by $1 3 million from $21 6 billion for the quarter ended March 31st 2021 to 22 9 million.
For the quarter ended March 31st 2022.
Bo Kruse: The increase affects our increased clinical trial, and employee-related costs, partially offset by decreased outsourced manufacturing expenses. SG&A expenses increased by $1.4 million from $12 million for the quarter ended March 31, 2021 to $13.4 million for the quarter ended March 31, 2021.
The increase reflects our increased clinical trial and any.
Employee related costs, partially offset by decreased outsourced manufacturing expenses.
SG&A expenses increased by $1 4 million from 12 million for the quarter ended March 31st 2021 to $13 4 million for the quarter ended March 31st 2022.
Bo Kruse: The increase in SG&A expenses primarily reflects costs related to the launch and commercialization of Dan Nielsen, which include a $0.7 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensation, as well as an increase in operating or commercial expenses. We reported a net loss for the quarter ended March 31, 2022 of $28.1 million or $0.64 per share basic and diluted compared to a net income of $33.4 million or $0.80 per share basic or $0.75 per share diluted for the quarter ended March 31, 2021.
The increase in SG&A expenses, primarily reflects costs related to the launch and commercialization upon Nielsen, which included $7 million increase in employee related costs, including salary benefits and non cash stock based compensation. That's what I was an increase in operating.
Commercial expenses.
We reported a net loss for the quarter ended March 31st 2022.
$28 1 million.
64 cents per share basic and diluted compared to a net income of $33 4 million or 80 cents per share basic or 75 cents per share dilutive.
For the quarter ended March 31st 2021.
The net income in the quarter ended March 31st 2021.
Bo Kruse: The net income in the quarter ended March 31st, 2021, including a $62 million net gain from the sale of our Danielle's Priority Review Voucher, after sharing 40% of the net proceeds from the sale with MSK. The decrease in earnings in the first quarter of 2022 was partially offset by the favorable impact of the NSF's growing revenues. We ended the first quarter of 2022 with a cash position of $156.7 million compared to $181.6 million at year-end 2021. The decrease of $24.9 million was driven by the cash used in operational activities for the quarter ended March 31, 2022.
Including a $62 million net gain from the sale of over 10 years. The priority review voucher after sharing 40 per cent of the net proceeds from the sale were damaged case, that's part of the license agreement with.
The decrease in earnings in the first quarter of 'twenty, two but was partially offset by the favorable impact of the Nielsen quoting revenues.
We ended the first quarter of 'twenty, two with a cash position of $156 7 million compared to 181 six months of your range at 21, a decrease of $24 9 billion was driven by the cash used in operational activities for the quarter ended March 31st 2020.
Sure.
Now in terms of the financial runway based on the re prioritization of the various pipeline programs, which Thomas mentioned, we currently estimate that our cash position of $156 7 million.
Bo Kruse: Now, in terms of the financial runway, based on the re-prioritization of the various pipeline programs which Thomas mentioned, we currently estimate that our cash position of 156.7 million is sufficient to cover our current operations to mid-2024. The underlying assumptions for this guidance are important to understand, so let me just explain that we took a conservative approach and did not include any assumptions for the net proceeds to be received on the anticipated PFE which we could sell upon the potential approval of Embedema. In addition, no new partnerships or other new BD-related sources of income are included.
Patient so cover our current operations so mid 'twenty fall.
Underlying assumptions for this guidance are important to understand so let me just explain that we took a conservative approach and did not include any assumptions for the net proceeds to be received in the sense of patent P IV, which we could sell upon approval.
Oh onto your potential approval of betterment. In addition, no new partnerships or the new BD related sources of income.
Sure.
Potential embedded map revenues upon approval.
Bo Kruse: Potential burden of revenues upon approval are also not included, and the Danyelta revenues are only assumed to increase modestly each year for the purpose of this analysis of one month. Just to be clear, we hope to see an entirely different growth range for the years in the years to come as we execute our refined commercial strategy and continue to deliver clinical data that could lead to expanded indications and greater physician adoption.
Also not included in the 10 years of revenues I only assume to increase modestly each year for the purpose of this analysis of runway.
To be clear, we hope to see an entirely different close rates for 10 years and years to come as we execute our refined commercial strategy and continue to deliver clinical data that could lead to expanded indications and greater efficient production.
In terms of development expenses, we have assumed the current programs.
Bo Kruse: [inaudible] In terms of development expenses, we have assumed that current programs would be advanced at our own expense and no new programs are assumed at this point. This forecast of financial runway benefits from the fact that most of the expenses related to pivotal trials, post-marketing commitments, and regulatory activities are behind us at this point. As disclosed in our press release last week, We are expecting operating expenses, of $162 to $167 million, and a total cash burn of $78 to $83 million for 2021. No public equity or debt offerings or borrowings are included in this guidance.
At our own expense and no new programs are assumed at this point.
This forecast our financial runway benefits from the fact that most of the expenses related to pivotal trials post marketing commitments and regulatory activities are behind us at this point.
It's close to in our press release last week, we are expecting operating expenses.
Oh, 160 to 267 million and a total cash burn of $78 million to $83 million for 2022.
No public what's your tape offerings of borrowings are included in this guidance.
Bo Kruse: We do believe Wanos remain in a healthy financial position to execute on its strategic priorities. Now this concludes the financial update, and I'll now turn the call back to Tom. Okay, thank you, Bo. This marks the end of today's prepared remarks.
We do believe whereas remain in a healthy financial position to execute on its strategic priorities.
This concludes the financial update.
Turn to call back some.
Okay. Thank you Bo this marks the end of today's prepared remarks at this time I'd like to open up the line for questions. Thank you.
Operator: At this time, I'd like to open up the line for questions. Thank you. Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star and then one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue.
[laughter].
Thank you Sam.
At this time, we will be conducting a question and answer session.
If you would like to ask a question. Please press star and then one on your telephone keypad.
Nation tone will indicate your line is in the question queue.
You need to start into a true if he would like to move your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. The first question we have is from Alec Stranahan from Bank of America. Please go ahead. Hey, guys. Thanks for the questions, two from us, both commercial. First on Danielza, 10.5 million in one queue. That's plus 9 percent quarter over quarter. I think we saw plus 7 percent sequentially in four queue. And if you look at the midpoint of the guidance range, are you thinking it's sort of a linear trajectory to continue from here?
Before passing the stocks.
The first question, we have you shouldn't Alec Stranahan from Bank of America. Please go ahead.
Hey, guys. Thanks for the questions two from US both are both commercial firsthand Daniels, a $10 5 million in one queue, that's plus 9% quarter over quarter, I think we saw plus 7% sequentially and <unk> and if you look at the midpoint of the guidance range Oh are you.
It's sort of a linear trajectory to.
To continue from here or are there some points for inflection later this year and as a follow up for for Sue maybe.
Alec Stranahan: Or are there some points for inflection later this year? And as a follow-up for Sue, maybe, could you just talk through your choice to expand outside of the academic treatment centers, sort of the considerations that went into this strategy shift? You know, what was maybe limiting uptake from your prior approach? And how do you plan to balance driving volumes while keeping SG&A in check?
Can you just talk through your choice to expand outside of the academic treatment centers.
Throw the considerations that went into this.
<unk> shipped you know what what was maybe limiting uptake from your prior approach and how do you plan to balance driving volumes, while keeping our SG&A in check and then a second question on Burton map I'm, assuming the FDA accepted the submission and then it gets approved what would be sort of involved in the launch efforts Thomas.
Alec Stranahan: And then our second question on BurtinMab, assuming the FDA accepts the submission and it gets approved, what would be sort of involved in the launch efforts? Thomas, you mentioned that, you know, there's really no added sales force that you would need for the launch. Could you just sort of describe the synergies in terms of, you know, what you've already built for Danielza? Thanks. Thank you, Alec. I'll let you take the first question, and then I'll go on to Burns.
You mentioned that you know the.
There's really no added sales force that you would need for the launch and could you just sort of describe the synergies.
In terms of what you've already built for Danielle. Thanks.
Thank you Alec.
I'll, let you take the first question and then I'll go on so that's one.
Sure.
Sue Smith: Sure, so in terms of Danielza, I think that we will see a fairly linear trajectory with more inflection in the second half of the year. In order to hit the 50 million, we need an average estimate of about 12 patients per month by the fourth quarter, and we've been averaging about six. So what is leading to that is essentially the patient identification, the team is very engaged in currently understanding the accounts, speaking with the multidisciplinary teams, and really, they have a very clear plan in terms of engaging compliantly with, earlier in the patient journey, for instance, talking to a bone marrow transplant doctor. And sometimes a rare disease can take six to 12 months from patient identification to time when it's appropriate for that patient.
In terms of.
Daniels them I think we will see a fairly linear trajectory with more inflection in the second half of the year.
In order to hit the 50 million, we need an average estimate doesn't.
12 patients per month by the fourth quarter, and we've been averaging about six so.
What is leading to that is essentially the patient identification. The team is very engaged in currently understand any kilns I'm speaking with the multi disciplinary teams.
And really we only have a very clear plan in terms of <unk>.
Engaging completely with you know earlier in the in the patient journey for instance, talking to a bone marrow transplant doctor and it sometimes in rare disease can take six to 12 months from patient identification to time, when it's appropriate for that patient. So they're currently when I say, we're filling the funnel that is.
Sue Smith: So they're currently, when I say we're filling the funnel, that is what I mean, and that's why we think we'll see the fruits of their efforts taking root by, you know, as we go through the year. So I see that as a more linear and justifiable growth. I think in terms of going outside of the, our first imperative is to maintain and grow in the academic center. So we're certainly by no means abandoning that focus, and we have made good progress there. But in terms of looking at the current market dynamics, we have seen actually during COVID, more of an interest of some parents to be closer to home and get treatment closer to home.
What I mean and.
That's why we think we'll see the fruits of their efforts taking route by you know towards as we go through the year, So I see that as a more linear and justifiable growth.
Do you think in terms of going outside of the where we are our first imperative is to maintain and grow your academic centers. So we're certainly by no means [laughter] abandoning that focus and we have made good progress there.
But in terms of looking at the current market dynamics, we have seen actually during COVID-19 more of an interest in some parents to be closer to home.
And get treatment closer to home and that really aligns well with our value proposition.
Sue Smith: And that really aligns well with our value proposition of the outpatient treatment setting. So by identifying through the claims, we know now where a patient could be turning up in the community setting, which we didn't have before. So the team is able to discriminate their time very specifically, go to an account knowing that they have a neuroblastoma pediatric patient, and spend their time there, you know, to engage and see if that's an appropriate patient.
Outpatient treatment setting.
So by identifying through the claims we know now where a patient could be turning up in the community setting, which we didn't have before.
So the team is able to discriminate their time very specifically go into an account knowing that they have a neuroblastoma.
And your lifestyle, the pediatric patient and spend their time there.
You know not to engage in and see if that's an appropriate patient so.
Thomas Gad: So that is essentially why we're doing this. And we see the trends going that way, and we're seeing the referral patterns and tracking those referral patterns with a plan around that. And so that's really, we're certainly engaging with academic centers, but we, and expanding there. But in the community setting, we're definitely seeing a lot more engagement and interest from those pediatric oncologists. Great. Thank you, Sue. So, Alec, to your second question.
That.
<unk> is essentially why we're doing this and we see that trend going that way and we're seeing a referral patterns and tracking those referral patterns with them you know our plan around that.
So that's really we're certainly engaging with academic centers.
But we and in expanding here.
But in the community setting, we're definitely seeing a lot more engagement and interest from those pediatric oncologists.
Oh, great. Thank you Sue so Alex your second question.
So yeah.
Thomas Gad: CNS metastases, you know, the way it works is normally that you come to control scans every three to six months after you're on full remission, systemic treatments, and it's the same KOL that will eventually diagnose the patient.
CNS metastasis as you know the way. It works is normally that you come to control scans every three to six months after you on full remission.
Stomach treatments and it's the same kols that will eventually diagnose the patient.
And you have a fairly long lead time.
Thomas Gad: And you have a fairly long lead time, into the treatment of ombudsman where there's no other therapy existing in the market. So it's basically the same doctors, same floors. There's logistic planning around it, so. Radio Safety Officers is what needs to be built up, but besides that, it's the same MSLs and pretty much the same team that can cover that indication.
Into the treatment of from birth from at where there's no other therapy existing in the market. So it's basically the same doctors.
Same floors, there's logistic planning around it so.
Radio safety officers.
What needs to be built up but besides that it's the same M S LS and pretty much the same team that can cover that indication.
So we should be fully ready to launch if we get approved.
Thomas Gad: So we should be fully ready to launch if we get approved. Got it. Thank you for the color and look forward to the continued progress.
Got it. Thank you for the color and look forward to the continued progress.
Thank you.
Thank you. The next question comes from Joseph Thome from Cowen and company.
Operator: Thank you. Thank you. The next question we have is from Joseph Tonk from Cohen & Company. Hi there.
Hi, there good morning, and thank you for taking my question, maybe the first one just could you you did mention partnership opportunities both for the adult indications and Daniel that and then also for <unk>.
Joseph Tonk: Good morning, and thank you for taking our questions. Maybe the first one, just because you did mention partnership opportunities, both for the adult indications of Danielza and then also for the SADA platform. How are you thinking about that? Are you prioritizing one agent over the other?
The Sada platform because how are you thinking about that are you prioritizing one agent over the other would you like one partner to kind of take both of these forward.
Joseph Tonk: Would you like one partner to kind of take both of these forward? And in terms of visibility, I know you said the next few months, is that for? Both products.
And in terms of visibility I know you said in the next few months is that for.
Both products.
Okay.
And then a follow up.
Thank you Joseph.
Thomas Gad: Thank you, Joseph. First talking about Danielsa, Danielsa is maturing as a great drug. Many potential indications, as DD2 is very well defined as a target.
First talking about Danielle something else that is maturing as a as a great drug.
Many potential indications S. T D. Two is very well defined as a target so.
So we are working on on that.
Thomas Gad: We are working on that. And, I think that's probably the most important part of it, and keeping our pediatrics while we are looking for partners, and discussing with partners going into larger indications, in the U.S. and actually in a global footprint. Going to Sara. Sara, we are envisioning. Multiple start-up partnerships. We're not envisioning one partnership.
Part of it and keeping all pediatrics, while we are looking for partners and discussing with partners going into larger indications.
In the U S and and actually in our global footprint.
I'm going to Sada Sadat weird.
Thomas Gad: We're envisioning optimizing the platform with third-party targets, and also going into large indications while we keep the pediatric unmet medical need indication. Great. And then I'm… I was just saying, as I said in my remarks, you know, the SADA platform works very nicely also by identifying you know, targets that have failed, but have proven safe in humans, couldn't manage to get a significant therapeutic index, and those can be optimized on the platform. So there's lots of work to be done on pilot.
Envisioning.
Multiple sada Sada partnerships, we're not envisioning one partnership with visiting optimizing the platform with third party targets.
And also going into larger indications, while we keep the pediatric unmet medical need indications.
Oh great.
I'm sorry go ahead.
Oh I was just saying as I said in my remarks, you know the Sada platform works very nicely also by identifying.
You know targets that have failed a proven safe in humans, but.
Couldn't manage together significant therapeutic index and those can be optimized on the platform. So there's lots of work to be done on partnerships.
Perfect and then I'm Danielle.
Thomas Gad: And then, on Danielta, do we have an update on when we could potentially see the updated titration program implemented officially into practice? And for osteosarcoma, are we still expecting data in the second half of the year from that? So I will take, I will turn it around and take the Austria-Jacoba question and I'll give Vignesh our.
An update on when we could potentially see the updated penetration program.
Implemented officially into practice.
And for Osteosarcoma or are we still expecting data in the second half of the year from that.
Thanks.
So I will take that will turn around and take the osteosarcoma question I'll give you that.
Yes, Oh.
Thomas Gad: A few other questions. So, osteosarcoma, we have a... Well, it's a multi-center trial going on at MSK. We have recruited 40 out of 49 potential patients. It is three sites. It's MSK.
Your other question so osteosarcoma, we have Ah.
Well, it's a multicenter trial going on at M. S. K, we've recruited 40 out of 49 potential patients it.
It has three sites. It's M. S. K, it's M D Anderson and it's C. H L. A are we do expect that to be fully recruited by then.
Thomas Gad: It's MD Anderson, to the floor. I'll hand over the other questions to Vignesh. Our Chief Medical Officer. I thank you, Dolores. Yes, good morning.
By the end of the year, and we hope to be able to share data with you as soon as possible. So that's the update on that and we are excited about.
That indication as well.
I'll hand over.
The other question to Vanessa.
Oh, Chief medical yesterday.
Hi, Thank you Thomas good morning, so regarding the step up infusion is a gradual increase in weighted infusion of Mexican amount, which we shared in previous calls.
Vignesh Rajah: So, regarding the... Step-up infusion is a gradual increase in radial infusion of maxidermab, which we shared in previous calls. The status for this, we are currently evaluating and validating the data where we have the most experience with this, in our expert referral center in Barcelona. Our principal investigator there has compiled all the data and has submitted an abstract for ASCO. So that's the date of the embargo, but it will be available shortly after the embargo date on May 26.
The status for this we are.
Currently evaluating and validating the data wherever we have the most experience with this.
Extra Grupo center in Barcelona.
The principal investigator of the <unk>.
Compile all the daytime has submitted an abstract for a.
So that's the data is embargoed, but people will be available shortly after the embargo date on May 26.
Vignesh Rajah: And we're also in preparation for a manuscript. Depending on the data and the validation of the data, our plan is to seek FDA advice regarding a label update, probably end of quarter two or quarter three, depending on the data validation. Once we've done that, of course, our plan is to incorporate this inclusion protocol regime in not only ongoing but future planned studies involving maxitumab, and this includes, for example, even our 201 study, once we've met our post-marketing requirement recruitment targets, as well as others such as osteosarcoma or even adult indications.
And we're also the preparation for a manuscript.
Depending on the data.
The validation of the data.
One is to seek FDA advice regarding a label update probably end of quarter two quarter three.
Pending the data validation once we've done that of course, we our plan is to incorporate this infusion protocol regime and not on the ongoing but future planned studies involving Mexico demand and this includes for example, even though to a one study once we've met all post marketing requirement recruitment targets.
As well as others, such as <unk>, such as I'll show, you saw come out or even adult indications. So throughout this stage once we get a obviously endorsement from the F D. A.
Vignesh Rajah: So, throughout this stage, once we get, obviously, endorsement from the FDA, and we are in a position to be able to implement these, we plan to then appropriately communicate that to our physicians and our prescribing community. So, yeah, this is our current plan at the moment with this Gradient Infusion Protocol. Great, very helpful. Thank you very much.
We are in a position to be able to implement these we plan to them appropriately communicate that's too long positions and prescribing community.
So this is the current plan at the moment with this grunted infusion protocol.
Great very helpful. Thank you very much.
Hum.
Operator: Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1. The next question we have is from Charles Zhou from Guggenheim. Please go ahead.
Ladies and gentlemen, just a reminder, if you would like to ask a question. Please press Star then one.
The next question is from Charles <unk> from Guggenheim. Please go ahead.
Okay.
Hey, good morning, everyone. Thanks for taking our questions. My first one perhaps on your leads Sato programs. So.
Charles Zhou: Hey, good morning, everyone, and thanks for taking our questions, of my first one, perhaps, on your lead SADA program. So, I guess, you know, given it sounds like you'll be ready to dose patients, in either third or fourth quarter of this year, and the IND was filed at the end of last year. I'm just kind of wondering, presumably the FDA has come back with questions on your IND filing. Could you perhaps provide a little bit more color around the topics around which they asked, as well as how you're tracking towards responding?
Given it sounds like you'll be ready to dose patients in either third or fourth quarter of this year and you know the I M. D was filed at the end of last year I'm, just kind of wondering you know presumably the F. D. A has come back with.
With questions on your IND filing could you, perhaps provide a little bit more color around you know the topics around which they asked as well as how youre tracking towards a REIT responding. Thank you.
Yeah, Steve I would like.
Steen Lisby: Thank you. Yeah, Steen, I would like to hand this question to you so you can give us a quick update on the IND process. Thank you. It's correct that we have interactions with the FDA, and currently we're very positive. We have very good dialogue, and... We anticipate there's no questions that we cannot answer to satisfy the FDA, but this will be a review issue, and we do expect to have clinical sites open and ready to dose in Q3 or in Q4 this year.
We'll have this question to you. So you get some quick update on the yeah. Indeed crosses.
Thank you.
Correct that we have the interactions with the food and drink and to be very positive that we have a very good dialogue.
And.
We anticipate there's no question that he cannot Oh I'm sorry.
To satisfy 15, but yeah, but.
But this wouldn't be a major issue and we do we expect to have clinical sites open and ready to dose it in.
Q3 or in Q4. This year. So are the proceeds from the clinical sites.
Steen Lisby: So the process for the clinical sites are a little bit different. Some sites start their approach when the IND is completely cleared, but we also are working with sites already now in order for us to be able to treat patients close to the time where we expect and hope for, and if the clearance of the IND is complete. Got it, got it. Great. That makes sense.
Different sometimes stocks their approach when the item you just couldn't get to see it but we also are working with sites already now in order for us to be able to treat peso close to the time, where we expect and hope for and if they could always that's the 19th.
Yeah.
Got it got it great that makes sense and if I may just have a bit of a follow up on that.
Charles Zhou: And if I may, you know, just have a bit of a follow-up on that, I think, you know, on prior calls, you had mentioned that you had already aligned with the FDA on the starting dose of 200 millicuries for this construct. So am I correct to presume, then, that perhaps the clinical module you have already aligned with the FDA and perhaps any remaining questions might surround, you know, potentially the CMC module, given that this is a very novel construct? Go ahead, Steen.
I think on prior calls you had mentioned that you had already aligned with the FDA.
The starting dose of 200 really carries a four this construct so am I correct to presume then.
That perhaps the clinical module you have already aligned with the FDA and perhaps any remaining questions might surround Patel.
Potentially the CMC module given that this is a very novel concept.
Oh go ahead sorry.
Yeah.
Steen Lisby: Err... We have, again, I cannot disclose details of the interaction with the FDA, but from the clinical side, I'm very, very positive and don't see any unforeseen events emerging. So we are very confident with the protocol that have been pre-discussed and revised during the discussions with the FDA. So we are very confident that we can open up the clinical trial when we get, hopefully when we get the IND clearance. Got it.
We have again I cannot disclose details I'm going to ask you where do you see but apart from the clinical side I am very very positive and don't see any Uh huh.
Charles Zhou: Great. I understand. And maybe one, a bit of a high-level question, more broadly, among radiopharmaceuticals. So it's not exactly a secret that things like supply chain manufacturing and CMC on radiopharmaceuticals perhaps have additional special considerations, and perhaps it's even a bit more telling now, given some of the recent news from Novartis. So could you guys also perhaps just provide your thoughts on to some of these recent occurrences, as well as how your internal supply and the supply chain really stack up relative to your near-term needs? Well, Charles, that's a, that's a... That's a long question.
Unforeseen events emerging so we are very confident with the protocols that have been discussed in the revised during the discussion with these D. So so we are very confident that we can oh I'm up the kidney can trial.
When do we get hopefully when you get to see.
I N T tiers.
Got it great I understand and maybe one a bit of a high level question more broadly.
Among radiopharmaceuticals, so it's not exactly a secret that things like supply chain manufacturing and CMC on Radiopharmaceuticals, perhaps have additional.
Special considerations and perhaps its even a bit more telling now given some of the recent leads from Novartis. So could you guys. You know also perhaps just provide your thoughts on to some of these recent occurrences as well as you know how how your internal supply and the supply chain really stacked up relative to your near term needs.
<unk>.
Well Oh, Charles that's a that's a that's a.
That's a long question.
You know I can say, we are very pleased with our CMC we've worked our.
Thomas Gad: I can say we are very pleased with our CMC. We've worked, for quite some years now on optimizing and the platform, and we feel our CMC is, actually one of the strong parts of the SADA platform and Y-mAbs, the IND, we expect that to be cleared in the third or fourth quarter, and you know, we don't, See any issues moving forward with I-5 or CMC. Got it.
For quite some years now on optimizing.
The platform and we feel our CMC is actually one of the strong cause them off the sada platform and Wimax.
And as Steve said, you know the <unk>, we expect that to to be clear in the third or fourth quarter.
And you know we don't.
See any issues moving forward, where that fly off C. M C.
Yes.
Yeah.
Got it great. Thanks for taking my questions.
Thank you. The next question we have Mr. Mike Phillips from Morgan Stanley . Please go ahead.
Mike Ulz: Great. Thank you. The next question we have is from Mike Ulz from Morgan Stanley. Please go ahead.
Great. Thanks, Good morning, everyone and thanks for taking the question just a quick follow up on the step dosing protocol for Danielle. So you mentioned a.
Vignesh Rajah: Great. Thanks. Good morning, everyone, and thanks for taking the question. Just a quick follow-up on the step-dosing protocol for Danielsa. You mentioned... Presentation at the upcoming ASCO meeting, I'm just curious if you expect any adoption following that, or is this really a situation where you probably need to update the label to sort of change? Physicians Practice.
At the upcoming Astro meeting I'm just curious if you expect any adoption following that or is this really a situation where you probably need to update the label to sort of change the physician's practice. Thanks.
Yes, so it's a.
Vignesh Rajah: Yes, so it's a publication, not a presentation, Alastair. Clearly, there will be a lot of interest from physicians who, as we know from day-to-day practice, are very interested in finding ways of mitigating particular infusion-related reactions, which we believe this new infusion protocol does address. Certainly, when we speak to physicians, they're looking forward to seeing this data, evaluating this, and potentially discussing this further with the investigator who's been driving this, Dr. Mora, from Barcelona.
Application or a presentation at asking clearly there will be a lot of interest from physicians.
Who as we know from day to day practice are very interested in.
Finding ways of mitigating, particularly infusion related reactions, which we believe this new infusion protocol does address suddenly when we speak to physicians. They are about they are looking forward to seeing this data evaluating this and potentially discussing this further with the investigators who has been.
Driving this Dr Mora from Barcelona now.
Based on what they see obviously, there will be some interest and uptake of this infusion schedule.
Vignesh Rajah: Now, based on what they see, obviously, there will be some interest in uptake of this infusion schedule. There has already been interest in adopting this in one of our investigator-sponsored studies, and Dr. Mora is obviously also independently discussing with physicians based on his experience. So, the simple answer to your question is, yes, I expect there will be some interest to adopt this as a result of the publication, but there will be a need to formally have this endorsed by the FDA, who will go through to make sure the collection, the validation of the data has gone through a rigorous process of this. So, the full publication of the manuscript is also being prepared in parallel, and that will be available later in the year. That's helpful.
There's already been interests and and adopting this in one.
One of our investigator sponsored studies.
And Dr. Morris, obviously also independently discussing with physicians based on his experience. So the simple answer to your question is yes, I expect there will be some interests to adopt this as a result of the publication, but there will be a need to formally have this endorsed by the F. D. A.
Go through to make sure the collection the validation of the data has gone through a rigorous process of this so the full publication of the manuscript is also being prepared in parallel and that would be available later in the year.
That's helpful. Thank you.
Yes.
Thank you ladies and gentlemen, just a final reminder, if you would like to ask a question. Please press star and then one now.
The next question, we have listened carefully I know who's a private investor.
Operator: Thank you. Thank you. Ladies and gentlemen, just a final reminder, if you would like to ask a question, please press star and then 1. The next question we have is from Kessler Romero, who is a private investigator. Hey guys, this is Tess from J.P. Morgan.
Kessler Romero: Thanks for taking our questions. First one for me is, I think it would be helpful if you can lay out for us what the key assumptions are underpinning the $45 to $50 million guidance for Daniella for sales for this year. And what do you assume for growth to net?
Hey, guys. This is <unk> from J P. Morgan.
My question first one for me.
I think it would be helpful. If you can lay out for us what the key assumptions are underpinning the 45 to 50 million guidance for Danielle that's more sales for them.
What do you assume for gross came out.
Kessler Romero: And then, second part of the question is just, do you have any insight regarding the real-world duration of treatment and what the trends have been looking like there? Thanks so much. Pavel, will you go ahead? Yeah, I'll be happy to, Thomas. So, essentially, our guidance of 45 to 50 million for the Danielse revenues for 2022 is to a very large extent, like 90 percent of it, of course, comprising the U.S. commercial revenues of Danielse.
And then second part of the question is just do you have any insight regarding the real world duration of treatment and what the trends have been looking like there. Thanks so much.
Oh will you go.
Go ahead.
Yeah, Yeah, I'd be happy to Thomas So essentially our guidance of 45 to 50 million for US and then you also revenues for 2022.
So a very large extent like 90% of the visit cost comprising the U S. Commercial revenues and also on top of that we have a modest number of vials being sold internationally.
Bo Kruse: On top of that, we have a modest number of vials being sold internationally. Thank you. So that's how it's all put together. And as you can tell from the first quarter revenues of $10.50, it doesn't take much of an increased quarter over quarter to really meet the, Pade Insolent, which is reflected in our guidance. And then I think it comes with providing our first ever guidance as a newly commercial company that we have to be careful in how we put this together.
At the.
Such a partner so that's at a lower price than what the U S market price would be and then to the extent partners are selling product during the course of 'twenty two.
We would receive some royalty income on top of that but the sale of <unk>.
Internationally and the royalty income is like less than 10% that's available.
So so that's how it's all put together and as you can tell from the first quarter revenue churn in our house.
It doesn't take much of an increase quarter over quarter to really meet the anticipated.
Interval.
Which is reflected in our guidance and then I think it comes with we provide.
Providing our first ever guidance.
That's a muni commercial company.
We have to be careful in how we put this together.
In terms of the gross to net we haven't really spoken about that publicly but what we've seen since the.
Bo Kruse: In terms of the gross net, we haven't really spoken about that publicly, but what we've seen since the... Thank you very much. The gross net percentage has been fluctuating quite a bit. It seems to be stabilizing over time, and for the last couple of quarters, we've been around the midpoint of 10 to 15%.
Since the launch.
Okay about a year ago is that for each quarter.
The gross to net percentage has been fluctuating quite a bit it seems to be stabilizing over time and for the last couple of quarters with that and around the midpoint of 10% to 15%, but it's it's really a lesson learned that in the beginning it fluctuated a lot.
Thomas Gad: But it's really a lesson learned that in the beginning, it fluctuated a lot, like very significant fluctuations been depending on, on the PHS and Medicaid and all of the other factors that goes into the questionnaire. But it's great to see that it's stabilizing and it's making our forecasting so much easier. Thank you, Paul. So, Tessa, the next question about duration on treatment. You know, the new strategy set up, which you can elaborate on, is catching patients earlier, meaning we're getting, moving, hopefully, our, Vignesh is down into second line more and thereby increasing. The average schedule for each patient up to more in line with what's in our clinical trial. You know, five cycles, but you can elaborate on that.
Very significant fluctuations depending on.
The Phs and Medicaid and all the other factors that goes into my question.
It's great to see that it's stabilizing and it's making our forecasting so much easier now.
Yeah.
Thank you well so says to the next question.
Duration on treatment.
The new strategy set up which would you kind of elaborate on this is catching patients earlier, meaning we are getting moving hopefully are.
Then you also down into second line more.
Thereby increasing.
T average.
Scott.
Scheduled for each patient up to more in line with it wasn't a clinical trial you.
You know five cycles, but sue you can elaborate on that.
Yeah. Thanks Thomas.
Thomas Gad: Yeah, thanks, Thomas. It's a very good question, Catherine. It's actually part of the thinking behind our revised approach, that about two-thirds of our patients are being treated per the label, but about a third of them are being used third-line for really a Hail Mary patient, so the duration of response is averaging much lower at around three months. So we are a two-fold approach. By going earlier, we're looking, as Thomas said, to hopefully engage the multidisciplinary team so that they're aware of us as an option, and then also looking to grow in community where they're not so entrenched with other products so that they are looking at us as an option to use us closer to the label. Great, thanks for taking our questions. The next question we have is from Sebastian von der Schutt from Chem10.
Catharine its actually part of the thinking behind our revised approach and.
About two thirds of honor and patients are being treated currently labor.
A third of them are being used third line for really a human or a patient does the duration of responses is averaging routes aren't around three months. So we are a twofold approach by going earlier, we're looking at is to understand totally engaged in a multi disciplinary team.
And as Nate said that they are aware of us as an option.
So.
You know looking to grow in the community, where they're not sort of entrenched with them.
Products. So that they are you know looking at us as an option to to use us closer to the labor.
Great. Thanks for taking my question.
Sure.
Yeah.
Thank you.
Next question here is from Sebastian.
Sebastian finish at Kensington. Please go ahead.
Hi, guys. Thank you for taking my question you mentioned the expansion of like sheet them up if it went to other GDP plus the adult indications is only if elevation.
Sebastian von der Schutt: Please go ahead. Hi, guys. Thank you for taking my questions. You mentioned that expansion of Nuxetamap development to other GD2-positive control indications is under evaluation with possible partners. I believe this was based on a reduction of the neuropathic pain through the step dosing program. But I believe that those were not completely resolved. Can you maybe recap what the safety profile looks currently like with the steps of dosing program and what the feedback is that you're getting from potential partners on that? Well, I'm not sure we can go through the whole safety profile, but we're getting very good interest in Danielsa as a drug for larger indications on a global footprint, and we are discussing that.
With possible partners.
I believe this was based on a reduction of the neuropathic pain towards step dosing program.
But I believe that those will not compete with so can you maybe recap what the safety profile looks currently like with the steps with dosing program and what the feedback that you're getting from potential partners on this topic.
Yes.
Well well.
I am not sure we can go through the whole safety profile, but but you know we're getting a very good interest and then you also as a drop a larger indications on our global footprint and we are discussing that.
Thomas Gad: And we are discussing how to bring it forward into these indications, and the Step-Up Protocol would obviously be part of that. I don't know, Vignesh, if you want to give a quick overview of the major. Yes, sir. Yes, I mean, the raison d'être for having this infusion, as you may recall, was this observation in a center that was using this on a compassionate use basis, where there was a notable reduction in the incidence of grade three, grade four adverse events, particularly for infusion reactions such as hypotension. And that was the basis for formalizing the data collection and this study that was conducted in Spain, with the data which will be shared at ASCO.
And we are discussing how to how to bring it forward into these indications and let's stay about protocol would obviously be part of that so I don't know Vanessa if you want to give a quick overview of the major.
Oh, yes.
Yes, Uh huh.
Yes, I mean, that's the raise on that for having this infusion because you might recall what was this observation in a center that was using this from a combustion use basis.
There was a notable reduction in the incidence of grade three grade four adverse events, particularly for infusion reactions, such as hypertension and that was the basis for a formalizing the data collection and this Ah study that was conducted in Spain.
The date of which will be shared at Oscar I'm not able to share the details of the results that came out of that.
Vignesh Rajah: I'm not able to share the details of the results that came out of that. But all I can share is that, you know, the... The expectation is that this will confirm our initial starting point, which is to see if this particular infusion reduces the risk of infusion reactions. Related to that, you mentioned also the link with the adult indications going forward. Absolutely, I think this is a key component to enable us to broaden our development of maxidermab in other indications where we do want to make sure we can take every action necessary to mitigate these kind of reactions, such as infusion relation or pain, for example.
That's all I can.
Sure is that right.
The expectation is that this room.
Confirmed our initial starting point, which is to see this particular infusion.
So the risk of infusion reactions not related to that you mentioned also the link with the adult indications going forward.
Absolutely I think this is a key component to enable us to broaden our development of mixing them up in other indications, where you know we do want to make sure. We can take every action necessary to mitigate these kind of reactions such as intrusion relation or paint for example, so.
Vignesh Rajah: So we are taking a keen interest in the results of this data, and based on this, we hope this will allow us also to explore new different schedules as well, not necessarily the current schedule in the pediatric population neuroblastoma, which is a day 1, day 3, day 5, 3 nits per kilo per infusion, but explore alternative indications that are more amenable to the adult patient population that you might see with other monoclonal antibodies on the market. Great, thank you so much.
We are taking a clean and hooper keen interest in the results of this data.
Based on this we hope this will allow us also to explore new different schedules as well not necessarily the current scheduled in the pediatric population neuroblastoma, which as of day, one day three day five Phoenix the killer.
Post infusion, but explore alternative.
Indications that are more amenable to the adult patient population that you might see with other monoclonal antibodies on the market.
Okay. All right. Thank you so much.
Yeah.
Great. Thanks, so much.
Okay.
Thank you ladies.
Vignesh Rajah: Thank you. Ladies and gentlemen, just a final reminder, if you would like to ask a question, please press star and then one. One moment, please, while we poll for more questions. At this stage, it seems there are no further questions. And with that, we have reached the end of our question and answer session. I would like to call the...
Ladies and gentlemen, just a final reminder, if you would like to ask a question. Please press Star then one.
Thomas Gad: Thank you, Thomas Gad, for closing remarks. Thank you. Thank you, everyone, for joining us this morning. Thank you to Y-mAbs and thank you to everyone else on the line. Have a great day. Thank you. Ladies and gentlemen, that concludes today's conference. You may now disconnect your lines. Thank you for your participation. © The Ultimate Parody Site!
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Yeah.
At this stage.
On the part of the question.
With that we have a question and answer session I would like to turn the call back to Thomas for closing remarks. Please go ahead.
Thank you. Thank you everyone for joining us. This morning. Thanks, that's why I'm actually thank you to everyone else on the line I have a great day.
Okay.
Thank you ladies and gentlemen that concludes today's conference you may now disconnect. Your lines. Thank you for your participation.
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