First Time Loading...

ADC Therapeutics SA
NYSE:ADCT

Watchlist Manager
ADC Therapeutics SA Logo
ADC Therapeutics SA
NYSE:ADCT
Watchlist
Price: 4.66 USD 5.67%
Updated: May 9, 2024

Earnings Call Analysis

Summary
Q3-2023

ZYNLONTA's Growth Amidst Challenges

The company is encouraged by positive data and expanding trials for ZYNLONTA to potentially open up significant opportunities. While recent declines in sales were primarily due to field force restructuring, the company remains confident in their growth strategy, focusing on community opportunities where ZYNLONTA offers an accessible off-the-shelf option, especially important where complex therapies are less accessible. The company is set to provide meaningful data from ongoing studies like LOTIS-7 in the first half of 2024, expecting to offer deeper insights as more patients participate over time.

Earnings Call Transcript

Earnings Call Transcript
2023-Q3

from 0
Operator

Welcome to the ADC Therapeutics Third Quarter 2023 Financial Results Conference Call. My name is Kathy and I will be your operator for today's call.[Operator Instructions] I'll now turn the call over to Eugenia Litz, Vice President of Investor Relations and Corporate Communications. Eugenia, you may now begin.

E
Eugenia Litz
executive

Thank you, operator. This morning we issued a press release announcing our third quarter 2023 financial results and business updates. This release is available on the ADCT website at ir.adctherapeutics.com under the Press Releases section.On today's call Ameet Mallik, Chief Executive Officer; Kristen Harrington-Smith, Chief Commercial Officer; Mohamed Zaki, Chief Medical Officer; and Pepe Carmona, Chief Financial Officer will discuss recent business highlights and review our third quarter 2023 financial results before opening the call for questions.Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include those related to our future financial and operating results, the impact of our updated strategic path forward including our commercial field strategy, portfolio prioritization and capital allocation and restructuring plan, our ability to achieve our guidance for 2023 operating expenses as well as our future cash requirement projections, future revenue growth, market acceptance, competition, and volume growth for products, product launches and market share for our product either alone or through our foreign partners, timing and results of ongoing and future development programs and clinical trials for our products, either alone or in combination with our partner products, FDA and foreign regulatory authorities actions and potential regulatory approval for our products, either alone or in combination with our strategic partners product, future strategic partnerships and business development efforts, our ability to regain and maintain compliance with the New York Stock Exchange listing requirements, our ability to repay our outstanding debt obligations, and future access to capital. These forward-looking statements are subject to certain risks and uncertainties and actual results could differ materially. They are identified and described in today's press release and the accompanying slide presentation on Slide 2, and in the company's filings with the SEC on Form 20-F, and as updated in ADCT's recent periodic filings on Form 6-K. ADCT is providing this information as of the date of today's conference call and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events or circumstances after the date hereof, except as required by law or otherwise. The company cautions investors not to place undue reliance on these forward-looking statements. Today's presentation also includes non-IFRS financial measures. These non-IFRS measures have limitations as financial measures and should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with IFRS. You should refer to the information contained in the company's third quarter earnings release for definitional information and reconciliations of historical non-IFRS measures to the comparable IFRS financial measures.It is now my pleasure to pass the call over to our CEO, Ameet Mallik. Ameet?

A
Ameet Mallik
executive

Thank you, Eugenia, and thank you all for joining us. Starting with ZYNLONTA, we had a challenging quarter with net sales of $14.3 million, down 33% year-over-year. The decline was attributable to the extended disruption on the field force restructuring, an increasing competitive environment and higher gross to net deductions. We continue to believe that restructuring the commercial model was necessary to fully capture the longer-term value of ZYNLONTA, and we expect to see progressive growth in the coming quarters. Kristen will provide further details shortly.Turning to our clinical development program for ZYNLONTA. Enrollment in our ongoing Phase 3 LOTIS-5 confirmatory trial in combination with rituximab in second line plus DLBCL is progressing well. In September we shared updated safety run-in results from LOTIS-5 SOHO Congress, which showed signs of durable responses and importantly, no new safety signals. In Japan, our partner Mitsubishi Tanabe has now joined the LOTIS-5 study to fulfill local regulatory requirements. Enrollment continues to progress as planned in our Phase 2 LOTIS-7 clinical trial of ZYNLONTA in combination with bispecifics for the treatment of DLBCL, follicular lymphoma and marginal zone lymphoma. We now expect to share initial data from this program in the first half of next year.We also look forward to expanding the clinical evidence base for ZYNLONTA with upcoming data from several ongoing investigator-initiated trials. These include the oral presentation from the University of Miami of a study exploring ZYNLONTA in combination with rituximab and follicular lymphoma at ASH in December. We also expect monotherapy data from an investigator-initiated trial in marginal zone lymphoma next year. Overall, these anticipated data updates are especially exciting as we see the current approved indication in third line plus DLBCL as a stepping stone to expanding the potential ZYNLONTA to earlier lines of therapy in combination in DLBCL and across other lymphomas.Turning to the remainder of our pipeline, we continue to strategically invest in our higher priority portfolio programs. We look forward to several potential value creating data readouts in the first half of 2024. In particular we expect to share initial Phase 1 data from ADCT-601 targeting AXL from ADCT-901 targeting KAAG1. We also expect additional Phase 1 data to be shared from ADCT-602 targeting CD22.Lastly, I want to highlight our continued progress and increasing operating efficiencies throughout the organization. This resulted in a 23% year-over-year decrease in operating expenses in the quarter. Going forward we will continue pursuing a disciplined approach in our capital allocation to ensure that we maintain our expected cash runway to mid-2025.To summarize, we're confident that we have the right team and strategy in place progressively drive ZYNLONTA growth. Our pipeline has several potential meaningful catalysts over the next 12 months, and we believe our expected cash runway provides us with the ability to execute our business plan. The team has a clear roadmap for execution, and I remain confident that we are on track to unlock the tremendous value in the company.With that I'd like to turn the call over to Kristen for a commercial update. Kristen?

K
Kristen Harrington-Smith
executive

Thanks, Ameet. Third quarter net sales of ZYNLONTA decreased by 33% year-over-year, impacted by disruption from the field force restructuring and the evolving competitive environment, particularly with the launch of bispecifics. We also faced gross to net headwinds from the Medicare Part B discarded drug policy. We continue to believe that restructuring our commercial model is critical to fully capture the longer-term value of ZYNLONTA. In particular, with our realigned field force, I am confident that we are now set up to most effectively reach treaters in the community where increasing awareness and trial is a top priority.While there was significant disruption during this period as around half of the field force was either entirely new or in new roles, I am happy to report that we are now fully ramped up and seeing strong customer engagement. This is an important component of our strategy to keep ZYNLONTA top of mind in the crowded DLBCL market.As you see on this chart, call volume has recovered to pre-restructuring levels, with an approximate 40% increase in August and September compared to the prior 4 months. Call volumes are one of the key leading indicators with the commercial impact typically lagging by a couple of months. This explains why we felt the brunt of the restructuring in the third quarter and also why we expect to see a return to growth over the coming quarters, particularly as we look into 2024. The pace of that growth will also depend on the evolving competitive dynamics. Despite the evolving competitive landscape, we believe ZYNLONTA has a clear role to play in the treatment of relapsed/refractory DLBCL today and over the long term. This is a highly fragmented market with no standard of care in the third line, third line plus setting and with different dynamics between the academic setting and the larger community opportunity.Bispecifics have seen early adoption in the academic setting. However, we are confident that ZYNLONTA will continue to play a role for patients who are either not suitable candidates for bispecifics or CAR-T or for patients who have progressed on these complex therapies. We believe maintaining a strong presence in this setting is vital as the experts in the academic centers are critical in recommending ZYNLONTA to the community treaters who patients are unwilling or unable to access complicated therapies like CAR-T and bispecifics. In addition, we have seen increased use of polatuzumab across all lines of DLBCL following their first-line approval. However, as it becomes more embedded as a frontline treatment, over time, we believe this should open up further opportunity for ZYNLONTA in the later lines. While it's important we maintain a solid base and influence in the academic setting, we continue to see the majority of the growth opportunity for ZYNLONTA in the community, and we are focusing our resources and efforts accordingly. For physicians in the community setting, ZYNLONTA represents a highly effective monotherapy with a manageable safety profile that can be administered in the outpatient setting. One of the major obstacles we face is that prescribing behavior in the community is slow to change due to the entrenchment of older and/or less effective agents. We understand the challenges, and I am confident that we have the right team and the right strategy in place to effectively position ZYNLONTA now as a monotherapy and in the future as we look to move to earlier lines of therapy in combination.With that, I'll turn the call over to Mohamed.

M
Mohamed Zaki
executive

Thank you, Kristen. It is my pleasure to share an update on the pipeline. We continue to focus our efforts and resources on the programs, which we believe have the highest potential to drive value. Enrollment in the Phase 3 LOTIS-5 study is progressing well. As a reminder, this trial examines the combination of ZYNLONTA and rituximab in second-line plus DLBCL patients not eligible for transplant. At the SOHO Congress in September, updated safety lead-in data from LOTIS-5 demonstrated an overall response rate of 80%, a complete response rate of 50% and a median duration response of 8 months with no new safety signals. This study includes patients that are difficult to treat, double-hit, triple-hit primary refractory to the last treatment, which represents the real-world patient demographic. While encouraging, we recognize that these data are from 20 patients cohorts out of the total plan 350 patients.Moving to LOTIS-7. This is our study to explore novel combinations of ZYNLONTA with Roche's bispecific glofitamab, or mosunetuzumab in relapsed or refractive non-Hodgkin lymphoma, including DLBCL, follicular lymphoma and marginal zone lymphoma. There is a tremendous amount of interest in this study from physician community. And if successful, we believe this novel combination could change the non-Hodgkin lymphoma treatment paradigm. We look forward to sharing initial data in the first half of next year.I would like to highlight that beyond our own clinical studies, we are encouraged to see substantial interest in the investigator community to explore ZYNLONTA in novel combinations and across multiple types of B-cell malignancies. We believe this will be important in identifying new reps to optimizing the potential of ZYNLONTA.Of note, I would like to highlight an ASH abstract published last week from University of Miami in this investigator-initiated trial, exploring ZYNLONTA in combination with rituximab in high-risk relapse or refractive follicular lymphoma. The combination was well tolerated with a 95% overall response rate at week 12 and at week 21, and 86% metabolic complete response rate. This is very encouraging, and we look forward to additional details in the oral presentation.Turning to the rest of the pipeline beyond ZYNLONTA, starting with ADCT-601, targeting AXL. Dose escalation is proceeding in patients with non-small cell lung cancer and sarcoma. Importantly, the maximum tolerated dose has not yet been reached. Based on preclinical data, we are adding a pancreatic cancer cohort with an enriched patient population. In parallel, we are working towards finalizing the immunohistochemistry assay for a possible biomarker approach. We continue to expect to share initial data from this prioritized Phase 1 trial in the first half of 2024.Turning to the ADCT-901 targeting KAAG1, dose escalation is also procceeding. As with 601, we are completing validation of the immunohistochemistry assay, and we expect to share initial data in the first half of 2024. Finally, dose escalation and expansion are proceeding in the Phase 1 trial of ADCT-602 targeting CD22 in patients with relapsed or refractory ALL in collaboration with MD Anderson Cancer Center. New clinical trial sites are being added to help accelerate enrollment. We expect additional data from the trial to be shared in the first half of 2024. I look forward to providing further updates on the progress of our pipeline over the coming months.And with that, I will turn the call over to Pepe to give a financial update. Pepe?

J
Jose Carmona
executive

Thank you, Mohamed. Before I get into the financials, I would like to reiterate our continued progress in achieving operational efficiencies throughout the business. We're confident in keeping operational expenses in both 2023 and 2024 below 2022 levels. This is crucial to funding the development of our key pipeline programs and maintaining our cash runway into mid-2025. As for Q3 performance, starting with our balance sheet, as of September 30, we had cash and cash equivalents of $310 million, representing a $37 million decrease from our position at the end of the second quarter.Moving to the P&L. As you already heard, ZYNLONTA net sales were $14.3 million in the third quarter. Moving down the P&L, our combined operating expenses on a non-IFRS basis, which excludes stock-based compensation were down 23% compared to the same period in 2022. This mainly reflected the operating efficiencies I referred to earlier. Together, we reduced R&D expenditures due to focused investment in our clinical studies and lower selling and marketing expenses. You can find the reconciliation of IFRS measures to non-IFRS measures in the compounding financial tables on the press release issued earlier today and in the appendix of this presentation.Moving to the bottom of the P&L. On an IFRS basis, we reported a net loss of $47.8 million for the third quarter or $0.58 per basic and diluted shares. Finally, this slide highlights the potential value-driving milestones, which we expect in 2024. We're looking forward to a catalyst-rich year ahead with initial data from several key programs in the first half, more mature data in the second half of the year and completion of LOTIS-5 enrollment during the year. We're also actively pursuing partnership opportunities and will continue to drive our productivity initiatives to enable capital allocation towards the most promising near-term value drivers. The potential catalyst in 2024 will shape the company's future to further serve patients and be able to create additional value.With that, I will turn the call back to Ameet for closing remarks. Ameet?

A
Ameet Mallik
executive

Thank you, Kristen, Mohamed and Pepe. To conclude, we are confident we have a clear roadmap as well as the capabilities to execute on our strategy to drive future value creation for all our stakeholders. We are excited about the future and look forward to keeping you updated on our progress. Now the team will be available for questions. Operator?

Operator

[Operator Instructions] Gregory Renza from RBC Capital Markets.

G
Gregory Renza
analyst

This is Paul on for Greg. I guess the first question I have is on ZYNLONTA. I'm just -- I noted that you mentioned that you expect growth to return over the next few quarters. Just curious if you can get to more on the granularity like how -- in terms of the quarters? Or you should plug in 2024, you see as a potential inflection? And to which point do you anticipate to provide guidance on ZYNLONTA again? And then I have a follow-up.

A
Ameet Mallik
executive

Yes, thanks for the question. Yes, I think as you can see, there are 3 reasons for the performance in Q3. One was close to disruption. As we have mentioned before, the time and depth of which we disrupted the field force to get to the right commercial model was longer. And so we expected and saw a disruption happen in Q3. We also saw it at a time of increasing competitiveness from new product entrants. And then finally, we had higher gross to net, especially when you look year-over-year, there is quite a bit higher gross to net in this quarter versus the prior year. So those are the 3 factors for the performance. Also, as you know, we adjusted the commercial model, knowing that bispecifics and other new entrants play bigger role in the academic setting, that the real opportunity was not the growth, it was going to be in the community. And so we reoriented the model to be able to win in the community. The field force is now back up and running. As of August, our call lines have returned back to normal. There's always a lag between activity and getting a new team and a new model up and running and when you see the impact. But we believe we will steadily see the impact and drive growth over the coming quarters. At this time, we're not providing any further guidance.

G
Gregory Renza
analyst

Got it. Understood. And then my second question is on LOTIS-7. I was wondering if you can remind us in terms of the synergy with bispecifics, do you anticipate to see that more on the response rate or on the durability side? And then what's the internal bar for advancing this program and would we get the clarity with the data that you shared in the first half next year?

M
Mohamed Zaki
executive

Yes. Thanks for your question, Greg. And actually, we see the potential for ZYNLONTA to be the combination agents like a backbone therapy. With the combination with bispecific, each one separately have demonstrated single-agent activity with distinct mechanism of action and known overlapping toxicities. The combination seems to be very interesting. The study of LOTIS-7 is progressing very well. We have not seen safety issues for the patients' dose so far. It's a dose escalation, we're continuing dose escalate. And hopefully, next year, we'll be able by mid next year, approximately to share more information on the dose escalation and possible some expansions. The uniqueness of this is that it could be a transformational combination in the landscape of non-Hodgkin lymphoma as a whole because the study includes 3 different types of diseases: DLBCL, follicular and marginal zone lymphoma. So investigators are very excited about it. We received interest and request to be part of the study almost on a weekly basis. In addition, we believe we could make a major change. And of course, as I mentioned, the landscape of DLBCL of this combination.

A
Ameet Mallik
executive

Yes. And then to get your question around what does good look like? Obviously, the fact that they can combine safely. Yes, the first and foremost thing that we're testing in dose escalation and other efficacy you want to see higher response rates than you would see with either agent alone. I think they're both highly active, so to get to CR rates that are higher than either agent alone and with durable response.

Operator

Boris Peaker with TD Cowen.

U
Unknown Analyst

This is Nick on for Boris. So my first one is, can you provide a little more color on the new commercial strategy? And how -- like what changes you've made to focus more on the community setting rather than on the academic setting? And then the second question is on gross to net, was it a higher gross to net for the year, like the highest gross net that you've had for the year? And do you expect this gross to net to continue moving on like years to come, quarters to come?

K
Kristen Harrington-Smith
executive

So I'll start with the changes to the commercial model. And like Ameet said, we absolutely believe that changing how we go to market was essential, particularly with the new competitive environment. Some of the key changes that we made were really adapting our model to local health care ecosystem. One of the key advantages that we have with this new model is that we have one well that is fully dedicated to driving demand in the community. These teams work together at the local level to make sure that they are aligned with how the referral patterns work. We're set up better to enable the leveraging of advocacy from the medical experts in the academic setting to the community treaters, so essentially who these community treaters turn to for advice or where they would generally send their patients. So making sure that we can leverage that advocacy from the academic centers to the community treaters is essential in this model.And we also overall improve the collaboration between the teams. With that, I can hand it over to Pepe.

J
Jose Carmona
executive

Yes. Thanks for the question. So on gross to net, we communicated at the beginning of the year that there were 2 elements that were going to impact gross to net in 2023 compared to 2022. One was the GPA contracting, and that will be in the 2 to 3 percentage points year-over-year. And the second one is in Medicare Part B Discarded Drug policy, which we said it would be between mid- to- high single digits. Those 2 elements are going to impact every quarter and have impacted the year-to-date numbers as well as Q3 numbers. So there's going to be always fluctuation from quarter to quarter. But that -- those are the key drivers. I cannot comment on the specific quarter. We don't disclose that data, but that's the main driver of the increase versus prior year.

A
Ameet Mallik
executive

One thing I'd just add to what Kristen said about the commercial model is, before we had people that were sort of working independently and you have systems of care that cut across territories. And when you're working independently, very tough to penetrate a more rare disease like third-line plus DLBCL, which are working in escalation. And now we have small focused teams that cut across academic and community to do a lot of the pull through that you were talking about. So teams really got up and running in August. So you don't see the result in the first 2 months completely, but I believe they're really hitting their stride right now and we'll start seeing the impact over time.

Operator

Naureen Quibria from Capital One Securities.

N
Naureen Quibria
analyst

I guess the first one that I have is either for Ameet or Mohamad. So you have that ASH presentation oral presentation from the IST study of ZYNLONTA with rituximab in follicular lymphoma. So seeing the early results. Are you considering a move into that setting now? Or is it too early?

M
Mohamed Zaki
executive

Thanks, Naureen. The population of this study, I want to highlight that is very difficult to treat patient population with follicular lymphoma, which we call POD24 high-risk patients. So, the data we observed in this study is really considered to be outstanding in the field of follicular lymphoma, specifically in [ lapsed effect ]. Specifically when you're talking about 95% overall response rate and 86% complete response, it doesn't get any better than that in this patient population. We are very excited, and we are actually the investigators who are doing this study are very excited about the ZYNLONTA and encouraged by it. We will expand the study to confirm the signal and also we plan to share this information with several investigators, not just the people who did it, others after ASH and during ASH. And based on that, we will determine the plans to move forward. And we will definitely inform the market. But no matter what the plan is, we will be doing it in the context of the disciplined capital allocation strategy. And also, I want to remind you that this is a step towards LOTIS-7, which actually in combination with another CD20, which about this time is much more stronger CD20 like bispecific and the follicular lymphoma is also included in LOTIS-7. So, it's a good initial strategy to see what the data looks like in combination with a rituximab and then hopefully, you'll transition into LOTIS-7.

A
Ameet Mallik
executive

Yes. And I think if you take a step back, Naureen, right now, we're playing with ZYNLONTA in almost a small set or playing a third line plus DLBCL. With LOTIS-5 and LOTIS-7, we're expanding to earlier lines in DLBCL, but also with some of these studies like you saw the follicular study now this IIT, and with LOTIS-7, we're expanding to other indolent lymphoma for follicular and marginal zone. So, we're in the smallest part of this as we keep getting encouraged by the positive data that we start seeing in combinations in these other settings. And I think that's going to open up the much bigger opportunity that we see for ZYNLONTA.

N
Naureen Quibria
analyst

And I guess one more, and this is probably for Mohamed. This is on the 601. You mentioned today in your prepared remarks that you're now including a pancreatic cohort. So can you just talk about what you've seen that you excited to include that now?

M
Mohamed Zaki
executive

Yes. As you might expect, we continue to develop our bioassay and patient selection and strategies. And as we're testing more tissues and more things, we observed that a high expression in pancreatic cancer. And based on our overall strategy to maximize and prioritize areas of potential success, we made the decision to increase the number of cohorts and expand to another strategic area, such as pancreatic cancer with a patient enrichment strategy and hopefully that's in addition to sarcoma and small cell lung cancer.

Operator

Kelly Shi from Jefferies.

U
Unknown Analyst

This is Yun for Kelly. The first question is on the LOTIS-7 data in first half 2024. Is it reasonable to expect that the number of patients, the amount of data will be similar to what you reported from LOTIS-5? And the second question is, sorry, if I missed it, but did you say that the data in first half of 2024 from 601, 901 will potentially have biomarker information included?

M
Mohamed Zaki
executive

Regarding LOTIS-7, as you know, there is dose escalation, and we, at this point, not sharing a specific number of patients. However, when we share the data, we'll be giving context around it, and we'll be been explaining it. In terms of other earlier program AXL and KAAG, we continue to dose escalate, and we are hoping to be able to see maybe a possible retrospective analysis in terms of bioassays or expression. But the validation of immunohistochemistry in those program is still ongoing, and we are not yet pre-selecting. We're doing retrospective analysis in the current available assay.

A
Ameet Mallik
executive

Yes. And then I just wanted to add to LOTIS-7, maybe some context on numbers. If you think about each dose cohort, there's 3 different dose cohorts possibly assuming a safety threshold on that. At each dose cohort, we're doing 6 patients, because in LOTIS-7 we're studying the combination with both mosun and glofit, so there's 3 patients in each. So theoretically, if you get through all 3 doses that could be up to 18 patients, right, if we get through all 3 dose cohorts. We believe we'll be through dose escalation and potentially into expansion by the -- in the first half of the year. So just to give you a context of numbers. Obviously, as the year goes on, we're going to keep getting more and more patients and more and more follow-up in terms of the data. So we're going to have a meaningful day in the first half of the year and probably even more meaningful data as you get into the second half of the year.

Operator

Brian Cheng with JPMorgan.

B
Brian Cheng
analyst

My first one is on just the trajectory of ZYNLONTA. Can you quantify or give us a qualitative view on how much of the disruption is due to competition versus restructuring of the commercial organization? How should we think of this underlying demand for ZYNLONTA and is the trajectory normalizing? And how do you feel about the next quarter or two? And I have a follow-up.

K
Kristen Harrington-Smith
executive

Sure. So it's difficult to quantify the impact from each. What we do know is that the majority of the decline was due to the prolonged disruption from the field force restructuring, we feel that we felt the brunt of that in Q3. At the same time, the competitive environment intensified right, and as anticipated, bispecifics are playing a growing role in the academic setting. That is why our strategy is to focus on growing the opportunity in the community. That being said, ZYNLONTA will continue to play a role in the academic setting, and the good news is we are now set up with our model to capitalize on that opportunity in both settings. We feel that we've got the right strategy and the right team in place, and we'll see the impact of their impact strengthen in the coming quarters.

B
Brian Cheng
analyst

And maybe just on competition. Can you talk about how the use of ZYNLONTA has been changed since the entry of bispecific and also the increasing use of CD19 CAR-T in the second line? And then just to follow up on your comments related to academic versus community doctors. How do you see about the split of academic versus community doc change? The ratio between the 2 change over the next couple of quarters? At what point do you think that you will be at a good time to, a good point to guide the Street on where -- what the next year will look like for ZYNLONTA sales?

K
Kristen Harrington-Smith
executive

Sure. So I'm going to break it down just a little bit. So we've seen that bispecifics of that an increasing impact in the academic setting as their launch progressive -- progresses. We see them as being used in the post-CAR-T patient or in some cases where patients won't necessarily get to CAR-T. So that's where we've seen their early use. And as anticipated, we've seen the majority of the use really in those academic settings because they are equipped to handle complex therapies like bispecifics.At the same time, we also know that not every patient will get to that academic center, whether if they don't have access to it or they are unwilling to travel and commit to going to an academic center, whether it's for a CAR-T or bispecific. We see that pattern is very similar. And that is what opens up the opportunity for a product like ZYNLONTA in the community where it is an off-the-shelf option that is accessible and provides a rapid response for patients who need it. You had a question around CAR-T in the second line. We do see an increase in the utilization of CAR-T as it becomes standard of care in the second line. But again, while it is increasing, we also continue to hear from physicians that is still a challenge for patients to get access to these complex therapies. There are different stats that are shared, whether it's 25%, 35% of patients who will get access to them.And then the -- let's see, the last question, when do we feel it will be a good point to give guidance.

A
Ameet Mallik
executive

Yes. I mean at this point, we're not adding guidance. Brian, but just one more thing I just want to say about the bispecifics. One is not every patient can tolerate a bispecific after the CAR-T. I mean once you fail on a CAR-T, so you're pretty sick, those patients are pretty sick at this point. So for those who could tolerate it, I think they're likely going to get a bispecific in that [ genomic ] center, but some patients can't. And a treatment like ZYNLONTA is about, a cleaner safety profile and also very fast action, a very fast time to assess response is critical for those patients. But also the majority of patients are going to progress post the bispecific. So also in the fourth-line setting, that starts to open up as well. So there's clearly a place for ZYNLONTA in academic setting. It's going to be less than what it was before, and we knew that was going to happen, which is why our strategy has been to adjust the model to capitalize on the bigger opportunity, which is growth in the community.

Operator

Thank you. There are no further questions at this time, and I will now turn the call back to Ameet.

A
Ameet Mallik
executive

Well, I just want to thank everyone for joining. Thanks for your interest in the company, and thanks for joining the quarterly update. We look forward to keeping you updated on our progress. And I hope everyone has a great day. Thank you.

All Transcripts