Q2 2021 ADC Therapeutics SA Earnings Call
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Operator: Thank you for your patience. The conference will start momentarily. Once again, thank you for your patience. The conference will start momentarily. Thank you.
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Operator: Welcome to the ADC Therapeutics Second Quarter 2021 Financial Results Conference Call. My name is Victor, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-answer session. During the question-answer session, if you have any questions, please press star, then one on your touch-tone. I want to turn the call over to Amanda Hamilton, investor relations and manager. Amanda, you may begin.
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Amanda Loshbaugh: Thank you, Operator. This morning we issued a press release announcing our second quarter 2021 financial results and business updates. This release is available on the ADCT website at ir.adcthropetics.com under the press releases section. On today's call, Chris Martin, Chief Executive Officer, Jennifer Heron, Chief Commercial Officer, Jay Feingold, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our second quarter 2021 financial results before opening the call for questions.
Yes.
Welcome to the ADC Therapeutics second quarter, 2021 financial results conference call.
My name is Victor and I'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question answer session. During the session. During the question. The answer session. If you have any question. Please press Star then 1 on your Touchtone phone.
Amanda Loshbaugh: As a reminder, this conference call may contain forward-looking statements. For additional information concerning forward-looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements, see We refer you to the section titled Cautionary Statement regarding forward-looking statements in Exhibit 99.3 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today. Such statements speak only as of the date of this conference call, and we expressly disclaim any obligation or undertaking to update these forward-looking statements unless required to do so by applicable law.
I'll now turn the call over to amend the Hamilton Investor Relations manager Amanda you may begin.
Thank you operator this morning, the issued a press release announcing our second quarter 2021 financial results and business update.
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On today's call, Chris Martin Chief Executive Officer, Jennifer Herron, Chief Commercial Officer Keith.
Thank God Chief Medical Officer.
And then for young Chief Financial Officer will discuss recent business highlights and review our second quarter 2021 financial results before opening the call for a question.
Amanda Loshbaugh: 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 second 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, Chris Martin.
As a reminder of this conference call may contain forward looking statements such statements are subject to risks and uncertainties for additional information concerning forward looking statements and factors that could cause actual results to differ materially from those expressed or implied in the statements. We refer you to the sections titled cautionary statement regarding forward looking for.
The line.
The 99.3 of our report on form 6K filed with the U S Securities and Exchange Commission or in the year today, such statements speak only as of the date of this conference call and we expressly disclaim any obligation or undertaking.
Chris Martin: Thanks Amanda, and thank you everyone for joining us today. The second quarter was nothing less than transformative for our company as we received our first accelerated FDA approval and brought Zinlanta, with its broad label and differentiated profile, to this area of high unmet medical needs. We achieved key objectives across the board, including commercial, clinical development, and corporate development goals. Let's start with our first commercial product.
These forward looking statements unless required to do so by applicable law.
Today's presentation also includes non I F. R. S financial measures. These non I FRS 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 I F. R. S. You should refer to the information contained in the.
Chris Martin: In April, we received Accelerated FDA approval for Zinlanter for our first indication in Relaptro Factory, DLBCL, and became a fully integrated biopharmac company. Today, it's early in the launch, and we're pleased with our progress and the positive reception from the physician and payer community. Jennifer Heron, our chief commercial officer, will share more details about our launch a little later in this call. On the R&D front, we continue to advance our pipeline programs, which we expect to also drive long-term value for the company.
Company second quarter earnings release for Definitional information and reconciliations of historical non <unk> measures for the comparable I FRS financial measure.
It is now my pleasure to pass the call over to our CEO, Chris Martin.
Thanks, Amanda and thank you everyone for joining us for Blake.
The second quarter was nothing less than transformative for our company as we received our first et cetera, I should the FDA approval of boats and lumps of with its broad label differentiation protocol to this area of high unmet medical need.
Chris Martin: We presented new data at ASCO and ICML on a few of our key programs, including updated duration of response for the pivotal Zinlantha Phase 2, Lotus 2 trial and the Phase 1 trial of Zinlanta in combination with Ebrusin. We also presented encouraging interim data for the phase two trial of our second program, Kami, and Hodgkin and Foams. Jay will elaborate further on these and our other programs in a few moments. We are also focused on expanding our geographic footprint, providing LONTA to as many patients as possible worldwide.
We achieved key objectives across the board, including commercial clinical development and corporates about the goals.
Let's start with our first commercial product.
In April we received the extended rescue the FDA approval, because there's lots of copel.
The indication and read out the 2 fire Creek DLP.
And because of a fully integrated Biopharma company.
Today, it's early in the launch we're pleased with our progress of the positive reception from the physician community.
Jennifer Herron, our chief commercial officer.
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Chris Martin: As you know, we formed the joint venture Overland ADCT Biopharma to develop and commercialize four of our products, including Zinlant, in Greater China and Singapore. The joint venture has made tremendous progress, including the appointment of the CEO, Eric Koo, who has substantial experience in China. Eric and his team are now making rapid progress towards initiating a critical bridge. As for Europe, we have recently engaged with EU regulators, and based on that feedback, we plan to submit a marketing authorization application to the EMA in the second half of 2021.
On the R&D front, we continue to advance our pipeline programs, which we expect to also drive long term value for the company.
We presented new data of <unk> and all of the CMO on the.
A few of our key programs, including update of duration of response for the pivotal as anyone sort of place to look just to troll and the phase 1 trial of <unk>.
In combination with Ibrutinib.
We also presented encouraging interim data for the <unk>.
These 2 trials of our second program Kennedy Hodgkin lymphoma.
Chris Martin: We are evaluating all of our go-to-market options and look forward to updating you on our plans for Europe when we have more specific details to share. I would now like to turn the call over to Jennifer to provide some insights from the early days of the Zinlaunton launch.
Jack will elaborate further on these at the all of the programs and a few items.
We also focus on expanding our geographic footprint for broad adoption.
The patients as possible worldwide.
As you know we pulled the joint venture Oberland, ADC <unk>, followed the polymer to the.
Jennifer Heron: Thank you, Chris. Good morning, everyone. Let me start with our focus, to bring Zunlanta to any third-line DLBCL patient who may benefit. We have an exceptional team of seasoned industry professionals who have executed very well with this single objective in mind. To that end, I'm happy to report that the Dinalanta launch is off to an encouraging start in its early stages. We are pleased to report DeLontan Net Sales in the second quarter of $3.8 million.
Developed and commercialized pool of our products, including Cymbalta, Greater China and Singapore.
The joint venture has made tremendous progress, including the heart the CEO Eric <unk>.
He has substantial experience in China.
Eric and his team all of them, making rapid progress towards the machine.
For the bridging study.
As for Europe, we have recently engaged with the regulators based on that feedback we plan for it makes the marketing authorization application for the Eni in the second half of 2021.
Jennifer Heron: This represents approximately two months of sales following approval in late April and reflects launch-to-date patient demand with no material inventory built. The encouraging early launch performance is the result of the strong execution of our seasoned cross-functional team of oncology professionals across medical, market access, marketing, sales, and commercial operations, all working together to educate physicians, nurses, and pharmacists on Zinlanta's differentiated product profile in third-line DLBCL, which remains an area of high unmet medical needs.
We are evaluating all of our go to market options. The look forward to updating you on the plans for Europe, when we have more specific details to share.
I would now like to turn the call over to Jennifer to provide some thoughts for the LD values of the deductible.
Jennifer.
Thank you Chris good morning, everyone.
Let me start with our silicon to bring isn't launcher to any third line D. L. P. C L patients who may benefit.
We have an exceptional team of seasoned industry professionals, who have executed very well with the single objective in mind share.
Jennifer Heron: Providing some additional context on the early launch dynamics, our commercial team has engaged all key accounts, with patient starts at a significant number of those. A substantial number of NCPN centers have ordered and reordered Dinlanta in Los Angeles. The differentiated Dinlanta product profiles, as reflected in our pivotal Lotus 2 trial, have been well received by both academic and community-based physicians. Zinlanta's consistent efficacy across a broad patient population, including heavily pre-treated patients and patients with difficult-to-treat diseases, its manageable safety profile, and ease of administration apply equally well to real-world patient populations in both academic and community settings, resulting in an approximate 50-50 split in terms of accounts ordering Zinlanta.
And I'm happy to report that there's been lots of launch is off to an encouraging start in its early stages.
We are pleased to report the launch of net sales in the second quarter of $3.8 million.
This represents approximately 2 months of sales following approval in late April and reflects launch to date patient demand with no material inventory built.
The encouraging early launch performance is the result of the strong execution of our seasoned the cross functional team of oncology professionals across the medical market access marketing sales and commercial operations.
All working together to educate physicians nurses and pharmacists on thin lots of differentiated product profile in third line D. L. Bcl.
Jennifer Heron: Over the next few quarters, we expect a greater proportion of Zinlanta volume to come from community-based physicians. Finally, we have seen significant increases in aided and unaided awareness, reflecting the impact of our hybrid launch approach and comprehensive digital campaign. In terms of access, we are pleased with our progress to date. Our payer and medical teams have actively engaged with key payer stakeholders, laying the groundwork for Swiss access. Nearly all key payer accounts have now been engaged, and we have made strong progress with published medical policies.
Which remains an area of high unmet medical need.
Providing some additional context on the early launch dynamics, our commercial team has engaged all key accounts.
With patient starts at a significant number of those accounts.
A substantial number of MTN centers have order and reorder demand.
The differentiated the lots of product profile as reflected in our pivotal notice to trial has been well received by both academic and community based physicians.
The launches consistent efficacy across a broad patient population income.
Jennifer Heron: With inclusion in the NCCN guidelines, just two weeks after accelerated approval, we are gaining access ahead of. We expect to receive our permanent J code in January 2022, which will help with local community reimbursement. As for operating in the COVID environment, we were fully prepared to launch under these exceptional circumstances and thus far have executed a strong hybrid line, with the flexibility to engage both virtually or in person, depending on geography and physician. We are encouraged to see increases in face-to-face visits, which we expect to continue to improve over the coming months.
Heavily pretreated patients and patients with difficult to treat disease.
Manageable safety profile and ease of administration apply equally well to the real world patient population in both of the academic and community settings, resulting in an approximate 50.50 split in terms of accounts ordering the long term.
Over the next few quarters, we expect a greater proportion of the lots of volume to come from community based physicians.
Finally, we have seen significant increases in aided and unaided awareness, reflecting the impact of our hybrid launch approach and comprehensive digital campaign.
Jennifer Heron: To summarize the first two months of launch, we are encouraged by the early positive launch momentum we've generated to date. However, we also recognize that these are early days of the Dinalanta launch, and there remains some uncertainty with the pandemic. However, we believe there is a lot of opportunity to continue driving awareness and demand. Our team is motivated, focused, and determined to bring Zinlanta to any third-line DLBCL patient who may benefit. We look forward to keeping you updated on our progress. Now, I'll turn the call over to Jay to provide an update on our pipeline, okay?
In terms of access we are pleased with our progress to date.
Our payer and medical teams have actively engaged with key payer stakeholders laying the groundwork for Swift access.
Nearly all key payer accounts have now been engaged and we have made strong progress with published medical policies.
With inclusion and the NCC guidelines just 2 weeks after accelerated approval. We are gaining access ahead of plan.
We expect to receive our permanent J code in January 2022, which will help with local community of reimbursement.
As for operating in the Covid environment, we were fully prepared to launch under these exceptional circumstances and thus far have executed a strong hybrid launch with the flexibility to engage both virtually or in person depending on geography and physician preferences. We are encouraged to see increases in face to face visits which we.
Jay Feingold: Beyond the first approved indications for Zimantha, we are exploring opportunities to expand the addressable patient population into earlier lines of treatment and into additional histologies. As Chris mentioned earlier, updated data from the Zamantha Pivotal Lotus 2 trial were presented at ASCO and ICML. The overall response rate was 48%, and the complete response rate was 25%.
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To summarize the first 2 months of launch we are encouraged by the early positive launch of momentum we've generated to date. We also recognize that these are early days of the didn't launch of launch and there remains some uncertainty with the pandemic. However.
However, we believe there is a lot of opportunity to continue driving awareness and demand. Our team is motivated focused and determined to bring to Atlanta to any third line D. L. Bcl patients who may benefit we look forward to keeping you updated on our progress.
Jay Feingold: As of the March 1, 2021 cutoff date, the median duration of response increased to 13.4 months for all respondents, with durable responses, even high-risk sub-grim. In addition, the median duration of response for pre-responding patients will not reach. As a reminder, the patient population of this trial included patients who did not respond to first-line therapy or any prior lines of therapy, patients who failed CART therapy or stem cell transplant, and patients with high These results reinforce the efficacy and safety of Lamenta as monotherapy, the manageable safety profile, and its convenient ease of administration.
Now I'll turn the call over to Jay to provide an update on our pipeline okay.
Thank you Jennifer.
Beyond the first approved indication for the market, we are exploring opportunities to expand the addressable patient population into earlier lines of treatment and into additional histology.
As Chris mentioned earlier updated data from this the months of pivotal Lotus to trial were presented at Astro in ICL.
The overall response rate was 48% in the complete response rate of 25 per cent.
As of the March 1.2021 cutoff date, the median duration of response increased to $13.4 months for all of responders.
The responses even high risk subgroups.
The median duration of response of responding patients was not reached.
Jay Feingold: David was recently presented at ICML from the Lotus Flu trial of Zimanda in combination with abutinib for patients with relapsed or refractory DLBCL or mental cell lymphoma. Updated phase one data showed encouraging efficacy and manageable toxicity with the overall response rate of 67% and a complete response rate of 38% in non-GCB subtype DLBCL patients. Based on interim data from the ongoing phase two trial, we have decided to amend the protocol to evaluate the administration of Zinlanta with every cycle to potentially further enhance efficacy and durability.
As a reminder, the pay.
The population of this trial included patients who did not respond the first line therapy for any prior lines of therapy patients, who failed car T therapy for stem cell transplant in patients with high grade T cell lymphoma, including those with double and Triple net genetics.
These results reinforce the efficacy and safety of the Martha as a monotherapy.
Safety profile is convenience ease of administration.
The data were recently presented of ICL from the Lotus free trial of the model the combination with ibrutinib for patients with relapsed or refractory <unk> or mental cell lymphoma.
Updated phase 1 data showed encouraging efficacy of manageable toxicity with the overall response rate of 67% and the complete response rate of 38% of non GCB subtype of <unk> patients.
Jay Feingold: Based on this additional data, we could potentially pursue a phase three study in second-line DOBCL, sparing any address an open market and a number of patients who could benefit from it. The phase two portion of this trial continues to enroll. Our ongoing confirmatory phase 3, Lotus 5, clinical trial of Zimlanta in combination with retoxmab is intended to support a supplemental BLA filing as a second-line therapy for relapsed refractory DLBCL patients not eligible for stem cell transport.
Based on the interim data from the ongoing phase 2 trial, we decided to amend the protocol to evaluate the administration of the model with every cycle to potentially further enhance efficacy and durability.
Based on this initial data we could potentially pursue of phase III study. The second line <unk> expanding the addressable market the number of patients who could benefit from the London.
So there's 2 portion of this trial continues to enroll.
Our ongoing confirmatory phase 3 lowest 5 clinical trial of the.
Jay Feingold: This trial continues to enroll patients, and we expect to complete the safety-leading portion of this trial in the second half of the year. There are plans to initiate several additional studies in the Manta trial in the second half of the year, including an umbrella trial in Lanta and multiple combinations in VLof subtractory B-Sel non-Hodgkin lymphoma. And a dose-finding study is in Manta in combination with R CHOPP and previously untreated DLBCL patients.
That in combination with Rituximab.
To support the supplemental BLA filing in the second line therapy for these absolute price, we deal bcl patients not eligible for stem cell transplant.
This trial continues to enroll patients and we expect to complete the safety lead in portion of this trial in the second half of the year.
We also plan to initiate several additional amounts of trial the second half of the year.
Including the umbrella trial this month at the multiple combinations of relapsed refractory b cell non hodgkin lymphoma.
Jay Feingold: These trials will explore the expansion of the Manta into early lines of therapy across Be-cell non-hatchkin and phone. Pivotal Phase 2 trial and relapse to refractive for Lickinininoma are now open for enrollment as well. As Chris mentioned, we planned to file for the MAA in Europe later this year based on the lowest two data.
I'm, just wondering studies of a month or the combination with R. Chop the previously untreated <unk> patients.
These trials will explore the extension of the month of into earlier lines of therapy of course.
B cell non Hodgkin lymphomas.
Pivotal phase 2 trial relapse refractory Follicular lymphoma is now open for enrollment as well.
As Chris mentioned the time.
Jay Feingold: From Ramin to Cami, we have made progress in both our Hodgkin lymphoma and solid tumor program. We completed enrollment in our 117 patient Pivotal Phase 2 trial and relapsed to refractory Hachkininin. Updated interim results were presented to ICML and showed an overall response rate of 66% and a complete response rate of 28% in a heavily pretreated population with a median of six protocols of systemic therapy. Medium duration response was not reached, and no new safety signals were identified.
All of the MAA in Europe late this year based on the lowest 2 data.
Moving to Tommy we have made progress with both of our Hodgkin lymphoma and solid tumor programs the.
The complete enrollment of all 117 patient pivotal phase 2 trial.
The refractory Hodgkin lymphoma.
Updated interim results, we are presenting the ICL and showed an overall response rate of 66% income.
The response rate of 28% the heavy.
The pre treated population the median of 6 prior lines of systemic therapy.
Median duration of response was not reached and no new safety signals have been identified.
We are encouraged by these results, which highlight the potential to address the unmet medical need in heavily pretreated Hodgkin lymphoma patients most of whom have failed stem cell transplant and all of whom have failed and tucks noted the checkpoint inhibitor.
Jay Feingold: We are encouraged by these results, which highlight the potential to address an unmet medical need and heavily pre-treated hospital hospital patients, most of whom have failed stem cell transplants, and all of whom have failed in Tuxtonamare of Doton and a checkpoint inhibitor. We look forward to providing additional updates as these data continue to mature. We also continue to advance CAME with our ongoing Phase 1B dose escalation trial in combination with Pemboluzumab and patients with advanced solitumids.
The approach providing additional updates as these data continue to mature.
We also continued to advance with our ongoing phase <unk> dose escalation trial in combination with Pam Goldsmith and patients with advanced solid tumors.
The data presented in the ESCO showed the current mono therapy has encouraged the safety profile and the Mac.
Jay Feingold: Data presented at ASCO showed that CAME MENTO therapy had an encouraging safety profile, and the maximum tolerated dose was not reached. It's also encouraging to see that treatment with CAME showed a significant increase in a T-affected-to-T reg ratio in a number of patients with T-cell infiltration of the tumors, which is thought to be associated with immune-related antitumor effects. If our county program exemplifies, we are deploying a validated ADC platform to achieve a solid tumor.
Some of tolerated dose was not reached.
It's also encouraging to see the to lose kind of showed a significant.
The increase T effector T Reg ratio and a number of patients with T cell infiltration of the tumors, which distorts the associated with immune related anti tumor effects.
So carrying program exemplifies the deploying of validated ADC platform for the Chilean solid tumors.
<unk> 9 of 1 targeting the average of tag 1 is a novel first in class candidate for the treatment of patients with advanced solid tumors the fire.
Jay Feingold: ADCT-901 targeting the antigen Cag1, is a novel first-in-class candidate for the treatment of patients with advanced solid tumors with high-hunt medical needs, including patients with platinum-resistant ovarian cancer and triple-negative breast cancer. We filed the IND for ADCT 9-1 in the second quarter, which the FDA cleared, and we expect to initiate the phase one study in the second half of this year. Another of our promising pipeline candidates, ADCT 601, targeting Axel, which has overexpressed in many solitubes, such as lung, breast, prostate, pancreas, clioma, and esophageal cancad.
Medical needs, including patients with platinum resistant ovarian cancer and triple negative breast cancer.
Finally, IMD for ADC to 9.1 in the second quarter.
The FDA cleared and we expect to initiate the phase 1 study the second half of this year.
Another of our promising pipeline candidates ADC <unk> 601.
It's targeting actual share over expressed in many solid tumors, such as lung breast prostate pancreas chorioma in esophageal cancer.
We expect to initiate the phase 1 of the combination study in multiple solid tumors in the first half of 2022.
Jay Feingold: We expect to initiate the phase 1B combination study and multiple solid tumors in the first half of 2022. In addition, our ADCT 602 program, targeting CB22, continues to enroll patients in a phase 1-2 trial for relapse through a factory acute lymphoblastic leukemia in collaboration with MDN. Finally, we have a robust R&D pipeline with six pre-clinical development programs, and we're the prolet to keep you updated on our progress. With that, I will turn the call over to Jen to give a financial update.
In addition, our ADC to 602 program targeting CD 22 continues to enroll patients in the phase 1.2 trial for relapsed or refractory acute lymphoblastic leukemia, the collaboration with MD Anderson.
Finally, we have a robust R&D pipeline with 6 preclinical development programs and we look forward to keep you updated on our progress.
With that I will turn the call over to Jim to give of financial update.
Thank you Jay and good morning, everyone.
Jen Creel: Thank you, Jay, and good morning, everyone. As reported in the press release issued earlier today, Zinlanta's second quarter net sales were $3.8 million, reflecting the two months of sales. As of June 30th, 2021, we had cash and cash equivalents of approximately $372 million as compared to approximately $383 million as of March 31st. During the quarter, we drew down the last $50 million tranche from our Deerfield facility, which was contingent upon Zimlanta approval.
As reported in the press release issued earlier today and the Atlanta second quarter net sales were $3.8 million.
In the 2 months of been lots of sales.
As of June 32021, we had cash and cash equivalents of approximately $372 million as compared to approximately $383 million as of March 31.2021.
The quarter, we drew down the last $50 million tranche from our Deerfield facility, which was contingent upon us in line to approval.
We used approximately $58 million and net cash for operating activities in the second quarter of 2021.
Jen Creel: We used approximately $58 million in net cash for operating activities in the second quarter of 2021. R&D expenses were $40 million for the second quarter of 2021, compared to $26 million for the same quarter in 2020. The increase was primarily related to the medical affairs support for the Zinlanta launch and the expansion of our Zinlanta clinical program and our broad portfolio. Selling and marketing expenses were $15 million for the second quarter of 2021, compared to $4 million for the same quarter of 2020. The increase in selling in marketing reflects the preparations for the DeLanta launch and the ongoing commercial effort.
R&D expenses were $40 million for the second quarter of 2021 compared to 26 million for the same quarter in 2020.
The increase was primarily related to the medical affairs support of the didn't want to launch and the expansion of ours in launch.
The nickel program and our broad portfolio.
Selling and marketing expenses for $15 million for the second quarter of 2021 compared to $4 million for the same quarter of 2020.
The increase in selling and marketing reflects the preparations for the launch of launch and the ongoing commercial efforts.
G&A expenses were $19 million for the second quarter of 2021 compared to $15 million for the same quarter of 2020. The increase was primarily due to the cost of being a public company.
Jen Creel: DNA expenses were 19 million for the second quarter of 2021, compared to 15 million for the same quarter of 2020. The increase was primarily due to the cost of being a public company. The net loss was $73 million for the second quarter of 2021, compared to a net loss of $127 million for the same quarter of 2020. The net loss included share-based compensation expense of $18 million for the second quarter of 2021. Our diluted net loss per share was 95 cents in the second quarter of 2021, compared to a net loss of $2.1 in the same quarter of 2020.
Net loss was $73 million for the second quarter of 2021 compared to a net loss of 127 million for the same quarter of 2020.
Net loss included share based compensation expense of $18 million for the second quarter of 2021 hour.
Our diluted net loss per share was <unk> 95 cents in the second quarter of 2021 compared to a net loss of $2 and 1 at the same quarter of 2020.
Finally, adjusted net loss of measure that excludes certain items associated with the Deerfield convertible loan and share based compensation expense was 54 million for the second quarter of 2021 compared to an adjusted net loss of $32 million in the same quarter of 2020.
Jen Creel: Finally, adjusted net loss, a measure that excludes certain items associated with the Deerfield convertible loan and share-based compensation expense, was $54 million for the second quarter of 2021, compared to an adjusted net loss of $32 million in the same quarter of 2020. The increase in adjusted net loss was primarily driven by the investment in the Zinlanta launch and our clinical program. The adjusted diluted net loss per share was 70 cents for the quarter compared to a loss of 51 cents for the same quarter of 2020.
The increase in adjusted net loss was primarily driven by the investment and is in line to launch and our clinical programs.
The adjusted diluted net loss per share was <unk> 70 for the quarter compared to a loss of 51 for the same quarter of 2020.
With that I will turn the call back to Chris for closing remarks, Chris.
Chris Martin: With that, I will turn the call back to Chris for closing remarks. Chris? Thank you, Jen and Jennifer.
Thank you J J and Jennifer.
To conclude this has been the productive and important first half 2021.
Chris Martin: Thank you, Jen, Jay, and Jennifer. To conclude, this has been a productive and important first half of 2021. We achieved important milestones, including, of course, the transformative changes in Lhunter, are prunable, and law. Our objectives for the remainder of the year are equally ambitious, and we are well positioned to execute on all aspects of the business. We look forward to updating you on the progress of our launch and our progress part-time in the coming quarter. I'm pleased now to open the call to your question.
We achieved important milestones including of course, the transformative Cindy hopes are critical for globe.
Our objectives for the remainder of the year are equally ambitious and we are well positioned to execute on all aspects of the business.
We look forward to updating you on the progress of our launch of dollar of bumps and thoughts on the coming quarters.
I'm pleased now to open the call to your questions.
Operations.
Okay.
Thank you we will now.
Operator: Thank you. We will now begin the question and answer session. If you have a question, please press star, then one on your touchstone phone. If you wish to be removed from the queue, please press the town sign or the hash key. If you are 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, then one on your Touchstone phone. Our first question on Comfortline is from Brian Chang from Cancer Fitzgerald. You may begin. Hey team!
I will begin the question and answer session. If you have a question. Please press Star then 1 on your Touchtone phone.
If you wish to be removed from the queue.
Please press the pound sign all of the hash key if youre 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 then 1 on your Touchtone phone.
Our first question comes from the line of Brian Cheng from Cantor Fitzgerald, you may begin.
Hey, Tim Congrats on the line John Thanks for taking my question.
Brian Cheng: Hey, team, congrats on the launch, and thanks for taking my question. It's good to see the 50-50 split-off between academic versus community docs using Solanza.
It's good to see the 50.50 split off I got the Amex alright, the community docs here. Thanks for launch, but can you talk about how that split coincides of your launch strategy and expectations and Kevin you have a differentiator of datasets in the double and triple hit the upside compared to other of reasonably approved agents do you see them more.
Brian Cheng: So can you talk about how that split coincides with your launch strategy and expectations? And given you have a differentiated dataset, you know, double-hidden, triple heads upset compared to other reasonably approved agents, do you see a more concentrated uptick there? And then I have a follow-up, thanks. Turn on a button.
We had an uptick there.
And then I have a follow up thanks.
I'm trying to book.
Yeah, Thanks, Chris and Brian Thanks for your question.
Jennifer Heron: Yeah, thanks, Chris. And, Brian, thanks for your question. As I mentioned in my remarks, our accounts ordering Zinlanta are split 50-50 across academic and community. And I think that's really reflective of the differentiated product profile, our broad third-line indication, ease of administration, and the fact that we haven't seen any significant payer barriers to date. We do believe that the versatility of Zin Lant's differentiated profile has enabled both academic and community physicians to identify patients who may benefit from ZNLonC.
As I mentioned in my remarks, our accounts ordering is in line to our split 50.50 across academic and community.
I think that's really reflective of the differentiated product profile are broad third line indication ease of administration and the fact that we haven't seen any significant payer barriers to date.
We do believe that the versatility of the launch of differentiated profile has enabled both academic and community physicians to identify patients who may benefit from the long term.
We do however, expect a greater proportion of patients that come from the community.
Jennifer Heron: We do, however, expect a greater proportion of patients to come from the community as an increasing number of medical policies are published and, ultimately, with our permanent J-code expected in January of 2022. And in terms of your question on double and triple hit subpopulations, from what we've heard anecdotally in the early weeks of launch, physician and patient real-world experience date has been consistent with the profile as described in the pivotal Lotus 2 trial in terms of efficacy, safety, and dosing across a broad patient population in third-line DLBCL. We haven't seen any specific concentration in subgroups.
As an increasing number of medical policies are published and ultimately with a permanent J code expected in January of 2022.
And in terms of your.
Your question on double hit Triple hit Subpopulation.
From what we've heard anecdotally in the early weeks of launch the physician and patient real World experience to date has been consistent with the profile as described in the pivotal loaded 2 trial in terms of efficacy safety and dosing across a broad patient population in third line <unk>.
We haven't seen any specific concentration in subgroups, we believe its being used broadly in alignment with our indication.
Jennifer Heron: We believe it's being used broadly in alignment with our indicator. Okay, thank you, Jennifer. And for Jen, just one quick one.
Okay. Thanks, Thank you Jennifer and then for Jen.
1 quick 1 for you in the $3.8 million number for the lines that how much of that is the go out of the EAP that you saw earlier this year, alright, thats organic new patient start and I know that you don't have inventory build this year should we expect any inventory of Bill later this year. Thank you.
Jen Creel: So in the $3.8 million number for Salonza, how much of that is rolled over from the EAP that you started earlier this year versus organic new patient starts? And I know that you don't have an inventory bill this year. Should we expect any inventory bill later this year? Thank you. So hi, this is Jen.
So.
Hi, This is jen thanks, Thanks, Brian for the question.
Jen Creel: Thanks, Brian, for the question. We did not have any significant material rollover from the EAP program. And then, I'm sorry, can you remind me of your second question? Sorry. Should we expect any inventory built later this year? We're not expecting any material build. The second quarter sales didn't have any material impact from an inventory build, and we're not expecting that in the future. Great.
We did not have any significant material.
Rollover from the EAP program.
And then I'm sorry can you remind me of your second question sorry.
Should we expect any inventory of belt later this year.
We're not expecting any material build the.
The second quarter sales didn't have any material impact from an inventory build and we're not expecting that in the future.
Great. Thank.
Unknown Speaker: Great, thank you, Chathson.
Thank you Catherine.
Matthew Harrison: Our next question is on the comfort line from Matthew Harrison from Morgan Stanley. You may begin.
Thank you.
Yes.
Our next question will come from the line of Matthew Harrison from Morgan Stanley You may begin.
Matthew Harrison: Great, good morning, thanks for taking the questions. I have two for you. So I guess first on launch dynamics. Can you maybe just talk about, I assume these are all demand patients and you didn't see any sort of bolus of patients waiting for the drug, but maybe if you could just confirm that. And then the second question is just around the ibupnebub combo. It sounds like there's a point here at which you're going to enroll more patients and then be able to speak to regulators about potentially a phase three program. Maybe you could just talk about when you think you're going to get to that point. Thanks.
Great. Good morning, Thanks for taking the questions 2 for me. So I guess first on on launch dynamics.
Can you maybe just talk about I assume these are these are all demand patients and you didn't see any sort of a bolus of patients waiting for drug, but maybe if you could just confirm that.
And then the the second question is just around the.
Of the Ibrutinib combo, it sounds like Theres, a point here at which you're going to enroll more patients in and and and then be able to speak to regulators about potentially of phase III program, maybe you could just talk about.
When you think you're going to get to that point. Thanks.
Jennifer do you want to call 1 of them J Paul too.
Chris Martin: Jennifer, do you want to take Part 1 and Jay Part 2? Yeah, absolutely.
Yes, absolutely Matthew Thanks for the question, Yes, I can confirm that we don't believe there was any pent up demand in Q2, largely because of the aggressive nature of the disease. So we do believe that all of the $3.8 million of net sales in Q2 reflects real time patient demand and more and more importantly, the unmet medical need for these patients.
Jennifer Heron: Yeah, absolutely. Matthew, thanks for the question. Yeah, I can confirm that we don't believe there was any pent-up demand in Q2, largely because of the aggressive nature of the disease. So we do believe that all of the 3.8 million in net sales in Q2 reflects real-time patient demand and, more importantly, the unmet medical needs for these patients.
And Matthew with regards to the burden of trial. This is Jay.
Jay Feingold: Matthew, with regard to the Brutnik trial, this is Jay. So we have to amend the trial, which always takes time to not only write but, more importantly, to get to the institutional review boards, the IRBs. So to do that, it's going to take a bit of time, and then we'll reopen for enrollment. And we really want to nail down the appropriate dosing regimen, and just as importantly, we want to make sure we find out with regard to cell of origin. And so we will take some time to enroll that study. So I'm not anticipating that we'll have much more to say about that study for, you know, into 2020. We'll see how it goes then.
So we have to amend the trial, which always takes time to not only right, but more importantly to get to the institutional review boards beyond the obese.
So thats kind of took a bit of time.
And then when we opened for enrollment and we really wanted to nail down the.
Appropriate dosing regimen and just as importantly.
We wanted to.
Make sure we find out with regard to sell of biology.
No.
We will take some time from rule that study so I'm not anticipating that we will have much more to say about that stemming from.
Into 2022, you won't see how it goes then.
Thank you.
Operator: Thank you. And once again, as a reminder, that's still one for questions. Our next question on Comfort Line is from Ken and McKay from RBC. You may begin. Hi.
Once again as a reminder, that's the 1 for questions.
The next question will come from the line of Kennan Mackay from RBC you may begin.
Hi, Thanks for taking the question maybe of initially of question on Germany.
Ken McKay: Hi, thanks for taking the question. Maybe initially a question on Cammy, after the data at ICML, can you maybe talk it all through around any regulatory interactions you've had around plans for an accelerated approval? And I'd love to also hear any K-W feedback you've had on the data as well as managing the incidence of GBS and whether there is what the current thinking is around that mechanism and whether there are any sort of preventative measures or even, you know, differences in expected incidents between lymphomas and solid tumors. And then I just have a quick follow-up on Zaylons.
After the debt ICM out can you maybe talk at all around any regulatory interactions you've had around plans for an accelerated approval.
I would love to also here for you all feedback you've had on the data as well as manager of the incidence of of.
GBS.
Whether they're the same.
What the current thinking is around the mechanism.
Whether there are of any sort of any preventative measures or even differences.
The expected incidents between lymphomas and solid tumors and then I just have a quick follow up on the same answer.
Okay. So.
Jay Feingold: Okay, so, sorry, Chris, this is Jay again. With you go to regulatory, we have, you know, in agreement with FDA from the end of Phase 1 meetings that we would follow patients for one year after the last patient was enrolled and responded to Cammy. We're in that time of follow-up right now, while the patients were enrolled in January. So we anticipate that we'll have data obviously in the first half of 2022.
Sorry, Chris This is Jay again.
We go into the regulatory we have.
And agreement with FDA from the end of Phase 1 meeting that we will follow patients for 1 year.
The last patient was enrolled and responded to county, where we're not the time to follow up right now all of the patients who enrolled in January.
So we anticipate that we will have data obviously in the first half of 2022 for then we have to review the data by the <unk>.
Jay Feingold: Then we have to review the data, write a BLA, submit the BLA, and go from there. Probably anticipate a regulatory path in terms of our planning similar to what we did in Monta, but we're not at this point advising yet on when we exactly plan to submit that BLA.
Submit the BLA and go from there.
However, we anticipate.
The regulatory path in terms of our planning similar to what we did for some months.
But we're not at this point of advising yet on when the exactly you plan to submit the BLA.
In terms of.
Jay Feingold: In terms of, um, care well feedback first with regard to a response, I think it's important to understand the patients we were treating in this study. So during ICML, we report on the first 101 patients involved in the study from the point of view of efficacy, and those patients had failed a meeting of fixed prior lines of therapy. All the patients failed a checkpoint inhibitor, all except one who had failed, and had failed, Brentoximab, Bedelton; that one, which was a mistake on the part of the investigator involving the patient.
Okay, well feedback first with regard to our response.
To understand the patients we're treating in this study so doing <unk>, we reported on the <unk>.
First 101 patients of all the study.
For the from the point of view of efficacy.
Those patients who failed the meeting of 6 prior lines of therapy all of the patients fulfill the checkpoint inhibitor of all except 1 of itself when tux Mab adult net 1.
For the mistake on the part of the investigator moving the patient and over 60% of the patients of sales from Central Samsung Samsung Sten.
Jay Feingold: And over 60% of the patients had failed stem cell transplants as well, but mostly autologous, some with auto, with ALO, and some with both. And despite all that, we had a 66% overall response rate and a 28% complete response rate, and we didn't reach the median duration response.
The stem cell transplant as well.
Most of the auto some of the auto.
For the Avalon and some with both of them and despite all of that we had of 66% overall response rate in the 28% complete response rate and we didn't reach the median duration of response I think it's important to understand all of that in the context of the safety issue of GBS clearly we believe.
Jay Feingold: I think it's important to understand all that in context of the safety issue of GBS. Clearly, we believe, our advisors believe, our independent data safety safety, the VINBOR believes, and FDA believes that there's enough anti-tumor activity in these very late-based patients to warrant the continuation of the study. And so the potential for a positive benefit over risk continues.
Absolutely.
The data safety monitoring board believes and the FDA believes that there's enough of antitumor activity of inventory late stage patients to warrant the continuation of the study.
And so the potential for a positive.
A positive benefit risk.
<unk> continues so that is why the study has continued in terms of GBS itself the.
Jay Feingold: So that's why the study is continued. In terms of GBS itself, the number of cases of GBS in this study are very similar to what we saw in the phase one study. We have never seen a case of GBS or polyradiculapathy in the B-cell lymphoma patients, the T-cell lymphoma patients, the acute leukemia patients, or the solid tumor patients that have been treated with CAMI. So there is some connection between the diagnosis of Hodgkin lymphoma and GBS, which is actually rare in the literature, and obviously some connection between being treated with CAME and GBS.
The number of cases of the GBS in the study very similar to what we saw in the phase..1 study we have never seen the case of GBS of Hollywood economically in the B cell lymphoma patients for the T cell lymphoma patients from acute leukemia patients or the solid tumor patients had been treated with kind of thing. So there is some connect.
Connection between the I guess of Hodgkin lymphoma.
In GBS, which is actually reported in literature, and obviously some connection between the treated with chronic.
In GBS.
We are continuing to investigate what that might be and if we can establish any risk features so far we haven't been able to do that.
Jay Feingold: And we are continuing to investigate what that might be, and if we can establish any risk features. So far, we haven't been able to do that. So we don't have any plan in place. Specifically to mitigate this, we do, of course, have all sorts of requirements for checking for viruses and other things that are known to be associated with GBS prior to enrollment in studies receiving CAME. So all that's in place. We'll continue to follow closely.
So we don't have any plan in place.
Specifically the mitigate we do of course have all sorts of requirements for checking for viruses and other things that are known to be associated with GBS prior to enrollment on the study the machine Tommy So all of that's in place. We'll continue to follow closely. It's important also of note that when the patients, which we quickly and aggressively with the onset of symptoms of GBS.
Jay Feingold: It's important also to note that when the patients are treated quickly and aggressively with the onset of symptoms of GVS, they generally do pretty well and recover fairly quickly. So definitely a serious issue of GBS, but so far, our investigators, advisors, the DSMB, and the FDA agree with us that the drug is certainly well worth studying in these Hodgkin patients with no alternative.
<unk> generally done pretty well and recovered fairly quickly so definitely a serious issue of GBS, but so far the investigators advisors.
<unk> and the FDA agreed with us that the drug is certainly well.
Studying from each hodgkin patients with no alternatives.
Okay.
Got it. Thank you know completely agree there and.
Ken McKay: Got it, thank you. No, I completely agree there.
You mentioned, the really unparalleled efficacy of the flights there.
Ken McKay: And as you mentioned, really unparalleled efficacy and those late-stage patients there in captions. Maybe just that follow-up on Zin Lanta. Just wondering if you could talk about progress getting Sin Lantone listed on hospital protocols, especially some of the largest academic centers. Is that at all associated with getting that permanent J-code, or is this sort of a step-by-step approach through those large academic centers? hospital. Thanks and congrats again on the quarter and the progress.
Each patient serves as the conscience, maybe just the follow up on <unk>. Just wondering if you could talk about progress getting sort of long term listed on hospital protocols, especially some of the largest academic centers does that.
At all associated with getting that permanent J code or is this sort of the.
Sure.
The step by step approach through the those large academic hospitals.
Chris Martin: Thanks, Ken. Jennifer, do you want to take that? Yeah, thanks, Chris. Kenan, thanks for the question.
And congrats again on the quarter and the progress.
Thanks, Kevin Jennifer do you want to take the.
Yeah. Thanks, Chris.
Jennifer Heron: Yeah, thanks, Chris. Kenan, thanks for the question.
Kevin Thanks for the question I think.
Jennifer Heron: I think from an access perspective, it all started with the fact that we got our NCCN guidelines less than two weeks after approval with a category 2A listing and recommendation. And that's really helped us accelerate all of our patient access efforts, as evidenced by our published medical policies, which we believe will enable faster access for patients, both in the community and in the academic centers. We haven't received significant pay or pushback, and I think that's reflective of the quality of our data, our documentation, such as our AMCP dossier, and the strong execution of our market access and medical teams.
From an access perspective, it all started with the fact that we got our Mtc and guidelines less than 2 weeks after approval with the category to a listing and recommendation and that has really helped us accelerate all of our patient access efforts and evidenced in our published medical policies, which.
Which we believe will enable faster access for patients both in the community and the academic centers.
We haven't received.
<unk> payer pushback and I think that's reflective of the quality of our data our documentation such as our a M. C. P dossier and the strong execution of our market access and medical teams and we are in general very pleased with our access to date through 3 of these medical policies, but it is early days and we anticipate receiving that permanent J code in the <unk>.
Jennifer Heron: And we are, in general, very pleased with our access to date through these medical policies. But it is early days, and we anticipate receiving that permanent J code at the beginning of 2022. In the meantime, we'll be continuing to support local community practices through our reimbursement and related services, which is called advancing patient support.
<unk> of 2022 and in the meantime, we will be continuing to support the local community practices through our reimbursement related services.
It's called advancing patient support.
Okay.
Thank you.
Jennifer Heron: Thank you. And I'm not showing any further questions in the queue. I'd like to turn the call back over to Chris for any closing remarks.
I'm not showing any further questions in the queue I'd like to turn the call back over to Chris for any closing remarks.
Well. Thank you very much for joining our call today every 1 of the if we look forward to keeping you up price you drilled out of progress so.
Chris Martin: Well, thank you very much for joining our call today, everyone, and we look forward to keeping you updated on our progress. So take care and stay safe. Thanks.
Take care of and stay safe.
Operator: This concludes the program. You may now disconnect. Music
This concludes the program you may now disconnect.
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