ADC Therapeutics - Q3 2023

Transcript

Operator (participant)

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. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star, then one, one on your touchtone phone.

I'll now turn the call over to Eugenia Litz, Vice President of Investor Relations and Corporate Communications. Eugenia, you may now begin.

Eugenia Litz (VP of Investor Relations and Corporate Communications)

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 our products, product launches and market share for our products,

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' products, 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, in the company's live 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?

Ameet Mallik (CEO)

Thanks, 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 following the field force restructuring and 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 at the 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 in 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 of 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, and 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 in 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 to 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?

Kristen Harrington-Smith (Chief Commercial Officer)

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 was 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.

Mohamed Zaki (CMO)

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, refractory to the last treatment, which represents the real-world patient demographic.

While encouraging, we recognize that these data are from 20 patients cohort out of the total planned 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 refractory 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 routes to optimizing the potential of ZYNLONTA.

Of note, I would like to highlight an ASH abstract published last week from University of Miami Investigator-Initiated Trial, exploring ZYNLONTA in combination with rituximab in high-risk relapsed or refractory follicular lymphoma. The combination was well-tolerated, with a 95% overall response rate at week 12, and at week 21, an 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 proceeding. 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?

José Carmona (CFO)

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 with 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 companion 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 we'll continue to drive our productivity initiatives to enable capital allocation toward the most promising nearer-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?

Ameet Mallik (CEO)

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 (participant)

Yes, thank you. We'll now begin the question and answer session. If you have a question, please press star one one on your touchtone phone. If you wish to be removed from the queue, please press star one one again. If you're using a speakerphone, you may need to pick up the handset first before pressing the numbers. Once again, if you have a question, please press star one one on your touchtone phone. One moment for our first question. Gregory Renza from RBC Capital Markets is on the line with a question.

Gregory Renza (Biotechnology Analyst)

Hi, thank you so much for taking our questions. This is Supriya for Greg. I guess the first question I have is on ZYNLONTA. I'm just I noted that you mentioned that, you know, you expect growth to return over the next few quarters. Just curious if you can get to more on the granularities, like how, you know, in terms of the quarters or, you know, which point in 2024 you see as the potential inflection? And to which point do you anticipate to provide guidance on ZYNLONTA again? And then I have a follow-up.

Ameet Mallik (CEO)

Yeah, thanks for the question. Yeah, I think as you can see, there are three reasons for the performance in Q3. You know, one was, of course, the disruption. As we had mentioned before, the time and depth of which we disrupted the field force to get to the right commercial model was longer than 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's quite a bit higher gross to net in this quarter versus the prior year. So those are the three factors for the performance.

Also, as you know, we adjusted the commercial model knowing that bispecifics and other new entrants would play a bigger role in the academic setting, that the real opportunity for ZYNLONTA growth was gonna 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.

Gregory Renza (Biotechnology Analyst)

Got it. 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, you know, with bispecific, do you anticipate to see that more on the response rate or more on the durability side? And then what's the internal bar for advancing this program, and would we get the clarity, you know, with the data that you will share in the first half next year? Thank you.

Mohamed Zaki (CMO)

Yeah. Thanks for your question, Greg. And actually, we see the potential for ZYNLONTA to be the combination agent of choice. It's like a backbone therapy. With the combination with bispecific, each one separately have demonstrated single-agent activity with distinct mechanism of action and no 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 dosed so far. It's a dose escalation. We're continuing to dose escalate, and hopefully next year, we'll be able, by mid-next year, approximately, to share more information on the dose escalation and possibly 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 three different types of diseases: DLBCL-...

follicular and marginal zone lymphoma. So investigators are very excited about it. We receive interest and request to be part of the study almost on a weekly basis. In addition, we believe we could make a major change in, of course, as I mentioned, the landscape of the DLBCL with this combination.

Ameet Mallik (CEO)

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

Mohamed Zaki (CMO)

Mm-hmm.

Gregory Renza (Biotechnology Analyst)

Got it. Thank you so much.

Operator (participant)

Thank you. One moment for our next question. Boris Peaker with TD Cowen is on the line with a question.

Nick Lorusso (Biotechnology Analyst)

Great. Thanks for taking our question. 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 to 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? Thanks.

Kristen Harrington-Smith (Chief Commercial Officer)

Hi, Nick, thanks for the question. So I'll start with the changes to the commercial model. And like Amit said, we absolutely believe that the 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 healthcare ecosystems.

One of the key advantages that we have with this new model is that we have one role 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 improved the collaboration between the teams. With that, I can hand it over to Pepe.

José Carmona (CFO)

Yeah, thanks for the question. So on gross to net, we communicated at the beginning of the year that there were two elements that were gonna impact gross to net in 2023. Compared to 2022, one was the GPO contracting, and that would be in the 2-3 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 two elements are gonna impact every quarter and have impacted the year-to-date numbers as well as Q3 numbers. So there's gonna be always fluctuation from quarter to quarter, but 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 increased gross per year.

Ameet Mallik (CEO)

Yeah, and the one thing I just-

Nick Lorusso (Biotechnology Analyst)

Great. Thanks very much.

Ameet Mallik (CEO)

One thing I'd just add to what Kristen said about the commercial model is, you know, 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, if you're working in isolation.

Now we have small focused teams that cut across academic and community to do a lot of the pull-through that she was talking about. So those teams only got up and running in August. So, you know, you don't see the results in the first two months completely, but I believe they're really hitting their stride right now, and we'll start seeing the impact over time.

Nick Lorusso (Biotechnology Analyst)

Understood. Thanks very much.

Operator (participant)

Thank you. One moment for our next question. Naureen Quibria from Capital One Securities is on the line with a question.

Naureen Quibria (Director & Senior Equity Research Analyst, Biotechnology)

Hi, good morning. Thanks for taking my question. I guess the first one that I have is either for Ameet or Mohamed. So, you know, you had that ASH oral presentation from the IIT study of ZYNLONTA with rituximab and follicular lymphoma. So seeing the early results, are you considering a move into that setting now, or is it too early?

Mohamed Zaki (CMO)

Thanks, Naureen. The population of this study, I want to highlight, that is very difficult to treat patient population with 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 relapsed refractory setting.

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 this data 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, no matter what the plan is, we will be doing it in the context of the disciplined capital allocation strategy.

And also, want to remind you that this is a step towards LOTIS-7, which actually in combination with another CD20, which but this time is much more stronger CD20-like bispecific, and the follicular form is also included in LOTIS-7. So it's a good initial strategy to see what the data looks like in combination with rituximab, and then hopefully you'll transition into LOTIS-7.

Ameet Mallik (CEO)

Yeah. I think if you take a step back, Naureen, you know, right now we're playing with ZYNLONTA in almost a small setting. We're playing in 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 lymphomas, like follicular marginal lymphomas.

So we're in the smallest part of this, and we keep getting encouraged by the positive data that we start seeing in combinations in these other settings. And I think that's gonna open up the much bigger opportunity that we see for ZYNLONTA.

Naureen Quibria (Director & Senior Equity Research Analyst, Biotechnology)

All right. That's really helpful. Thank you. 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 know got you excited to include that now?

Mohamed Zaki (CMO)

Yeah. As you might expect, we continue to develop our bioassay and patient selection strategies. As we testing more tissues and more things, we observe that a high expression in pancreatic cancer. 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 therapeutic area, such as pancreatic cancer, with a patient engagement strategy, and hopefully that's in addition to sarcoma and most lung cancers.

Naureen Quibria (Director & Senior Equity Research Analyst, Biotechnology)

Okay, great. That's all for me. Thank you.

Operator (participant)

Thank you. One moment for our next question. Kelly Shi from Jefferies is on the line with a question.

Yun Zhong (SVP, Senior Research Analyst, Biotechnology)

Hi, good morning. This is Yun for Kelly. Thanks very much for taking questions. So, the first question is on the LOTIS-7 data in the 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 ADCT-601, ADCT-901, will potentially have biomarker information included? Thank you.

Mohamed Zaki (CMO)

Regarding LOTIS-7, as you know, this is a dose escalation, and we, at this point, not sharing specific number of patients. However, when we share the data, we'll be giving context around it, and we'll be very well explaining it. In terms of other earlier programs like AXL and KAAG1, 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 the immunohistochemistry assay in both programs is still ongoing, and we are not yet preselecting. We're doing retrospective analysis of the current available assay.

Ameet Mallik (CEO)

Yeah, and then just one thing to add to LOTIS-7, just give you some context on numbers. If you think about it, each dose cohort, there's 3 different dose cohorts, possibly, assuming again, safety thresholds are met. At each dose cohort, we're doing 6 patients, because in LOTIS-7, we're studying the combination with both mosunetuzumab and glofitamab.

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, if we get through all 3 dose cohorts. We believe we'll be through dose escalation and potentially into expansion by the first- in the first half of the year. So just give you a context of numbers. Obviously, as the year goes on, we're gonna keep getting more and more patients and more and more follow-up in terms of the data.

We're gonna have meaningful data in the first half of the year and probably even more meaningful data as you get into the second half of the year.

Yun Zhong (SVP, Senior Research Analyst, Biotechnology)

Great. Thank you.

Operator (participant)

Thank you. One moment for our last question. Brian Cheng with JPMorgan is on the line with a question.

Brian Cheng (Analyst)

Hey, guys. Good morning. Thanks for taking my question. 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 the underlying demand for ZYNLONTA? And, you know, is the trajectory normalizing, and how do you feel about the next quarter or two? And I have a follow-up. Thank you.

Kristen Harrington-Smith (Chief Commercial Officer)

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've 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.

Brian Cheng (Analyst)

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? Then just to follow up on your comments related to academic versus community doctors, how do you see about the, you know, the split of academic versus community doc change, you know, the ratio between the two change over the next couple of quarters? At what point do you think that, you know, you'll be at a good time to a good point to guide the street on where, you know, the what the next year will look like for ZYNLONTA sales? Thank you.

Kristen Harrington-Smith (Chief Commercial Officer)

Sure. So, I'm gonna break it down just a little bit. So, you know, we've seen that bispecifics have had an increasing impact in the academic setting as their launch 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 it's 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 a 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 it 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'll be a good point to give guidance on it?

Ameet Mallik (CEO)

Yeah, I mean, at this point, we're not, we're not adding guidance, Brian. But one, one more thing I just wanna say about the bispecifics. You know, one is not every patient can tolerate a bispecific after a CAR T. I mean, once you fail a CAR T, so you see, you're pretty sick.

Those patients are pretty sick at this point. So for those who can tolerate it, I think they're likely gonna get a bispecific in academic center, but some patients can't. And a treatment like ZYNLONTA, with a cleaner safety profile and also very fast action, you know, very fast time to adjust response, is critical for those patients. But also, the majority of patients are going to progress post a bispecific. So also in the fourth line setting, that starts to open up as well.

So there's clearly a place for ZYNLONTA in the academic setting. It's gonna be less than what it was before, and we knew that was gonna happen, which is why our strategy has been to adjust the model to capitalize on the bigger opportunity, which is growth in the community.

Brian Cheng (Analyst)

Great. Thank you so much. That was very helpful. Thank you.

Operator (participant)

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

Ameet Mallik (CEO)

Well, I just wanna 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.

Operator (participant)

This concludes our program, and you may now disconnect. Thank you.