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Immunomedics Inc (NASDAQ:IMMU)
Q2 2020 Earnings Call
Aug 5, 2020, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. As a reminder, this conference call is being recorded today, this Wednesday, August 5, 2020.

At this time, I'd like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics. Sir, please begin.

Chau Cheng -- Senior Director, Investor Relations

Thank you, Norma. Good afternoon, everyone. Welcome to Immunomedics Second Quarter 2020 Conference Call. Please note that we have supporting slides accompanying today's call. You can access those slides on our website on our IR page.

With us on the call today are Dr. Behzad Aghazadeh, Executive Chairman, who will give a quick overview of the quarter; Brendan Delaney, Chief Commercial Officer, who will provide early commercial uptake commentary and metrics; Dr. Loretta M. Itri, Chief Medical Officer, who will walk us through clinical development priorities and forthcoming updates; and Usama Malik, Chief Financial Officer and Chief Business Officer, who will provide you with an overview of our financial this past quarter before opening the call up for questions.

Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties. Therefore, actual results could differ materially from those expressed or implied on this call. Factors that may cause such a difference includes the uncertainty associated with pharmaceutical development and the regulatory approval process as well as difficulty in forecasting sales, revenues and expenses.

More information about the risks and uncertainties faced by Immunomedics is contained under the caption Risk Factors included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's annual report on Form 10-K for the year ended December 31, 2019.

With that, let me turn the call over to Behzad.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thank you, Chau. Good afternoon, everyone and thank you for joining. Second quarter 2020 was transformative for Immunomedics. In particular, we reached important milestone of receiving our first ever drug approval from the FDA and were able to launch Trodelvy in the US within one week of FDA's accelerated approval. Clinically, we delivered on our promise to report top line results from the confirmatory Phase III ASCENT study in mid 2020, and the results clearly demonstrated the significant benefit Trodelvy is bringing to patients with metastatic triple negative breast cancer. Financially, we successfully bolstered our balance sheet with a very well received offering and are well positioned to fund our solid growth trajectory.

And finally, as the world continues to contend with the challenges presented by the COVID-19 pandemic, I'm [Technical Issues] of our organization for rising up to the challenge and effectively navigating this difficult period, delivering in virtually every aspect of our business and fulfilling our promise to patients and shareholders. While we are still early in our launch, it is clear that Trodelvy has been well received by patients and their treating physicians alike. In only two short months since approval, we achieved $20.1 million in net sales.

I would like to thank Brendan and his entire commercial team for pulling off such a great start. Energized by this early success, we're going to push harder to have more patients benefit from this important new treatment. We believe this quick adoption of Trodelvy is clear evidence that we have a highly differentiated product in a difficult-to-treat cancer with a dire unmet need. And Brendan will have a lot more to say on this topic in a few moments.

Trodelvy's excellent risk-benefit profile has recently been corroborated by the confirmatory Phase III ASCENT study. In a study that involved more than 500 patients, treatment with Trodelvy resulted in a 59% reduction in the risk of cancer progression compared to single agent chemotherapy. More importantly, Trodelvy also met the key secondary endpoints of this study, including overall survival and objective response rate.

With these results, Trodelvy becomes the first antibody drug conjugate or ADC to improve the clinical outcomes in people with relapsed or refractory metastatic triple-negative breast cancer who have received two prior therapies. More broadly, we are proud to be the first company to bring an anti-Trop-2 ADC to patients and successfully validated Trop-2 as a target for cancer treatment in the process.

Trodelvy has a unique and differentiated safety and efficacy profile that is distinct from other ADCs in that the major emergent -- adverse events across multiple tumor types are hematologic and gastrointestinal in nature, which are reversible and well manageable. I strongly believe this differentiated safety profile will become even more critical as we brought in Trodelvy's development activities into earlier lines and combination settings. Loretta will provide you with a more comprehensive update of our clinical studies momentarily. And of course, we look forward to the presentation of significantly more information at upcoming medical conferences.

But first, Brendan will now discuss in greater detail our launch and our commercial progress today.

Brendan Delaney -- Chief Commercial Officer

Thank you, Behzad. It is an exciting time at Immunomedics, and I'm thrilled to have the opportunity to update you today on the exceptional launch of Trodelvy in triple-negative breast cancer. I've given many presentations over the last few years detailing the significant market opportunity for this product, highlighting the strength of our commercial team and describing the intense preparation by our entire organization.

Now the time has come to finally share how all of that work has culminated into a very strong product launch, where the results truly speak for themselves. It is humbling to think that behind all the launch metrics and behind all the early launch success are the women who are battling triple-negative breast cancer who now have access to this important new treatment option. They represent the most meaningful success story of this launch.

Since receiving FDA approval on April 22, our launch has been driven by three strategic imperatives. First, we need to quickly establish Trodelvy as a standard of care after two prior treatments in the metastatic setting. In order to accomplish that goal, as with any new product launch, our ability to accelerate brand awareness is paramount to success. It is too early to share meaningful brand awareness metrics. However, the overall breadth of ordering institutions and the rapid Trodelvy uptake within the community oncology setting leads us to believe that our brand awareness metrics are tracking ahead of target.

Next, our teams have been focused on managing expectations for treatment and educating healthcare providers to ensure a positive first clinical experience. Based on feedback from first time Trodelvy prescribers, these early adopters have a positive reaction to the clinical profile of the drug, which many described as predictable and manageable and it appears that these new users can effectively initiate treatment and manage patients through multiple cycles of therapy.

It is also encouraging to hear that early signs of clinical benefit seemed consistent with what has previously been observed in the clinical trial setting. Lately, throughout the early launch, we have continued to strengthen our partnerships within the breast cancer community by putting the needs of patients first. We will continue to differentiate Immunomedics as a leader in the triple negative breast cancer space.

Nothing demonstrates that leadership or our commitment to patients and their providers more than the sense of urgency with which our organization has executed this important launch. Knowing that a launch strategy is only as good as the tactical execution on the ground, it's important to highlight some of these accomplishments, starting with our ability to make drug available across the distribution channel within the first week of approval.

Patients, caregivers and oncologists have been anxiously awaiting Trodelvy's approval. So I applaud my Immunomedics colleagues for finding every way possible to shave days, hours and even minutes off the drug availability time line. Despite the headwinds that launching within COVID-19 pandemic can -- have presented, our launch teams never wavered and never lost focus. Their execution started with trodelvy.com going live within hours, quickly followed by representatives educating prescribers within 24 hours and peer-to-peer education programs being executed during the first week on the market.

Launched to date, over 1,000 healthcare providers in the United States have attended a Trodelvy education event. Through these ongoing education efforts, many of these healthcare providers are being exposed to the clinical profile of Trodelvy for the first time. It is important that they understand how to initiate and manage patients optimally in order to achieve best clinical outcomes.

Based on early feedback, the reaction to the Trodelvy clinical profile has been positive and many oncologists expressed the comfort with managing patients on therapy. Although early market share estimates can be unreliable, recent market research conducted with community oncologists in the US revealed that intent to prescribe Trodelvy in the third line treatment setting exceeded 80%.

During the early launch, we have also had a strategic focus on the top 150 breast cancer accounts in the United States, which represent over 50% of the potential within the market. I'm happy to report that through the first-two months, penetration into that group of accounts exceeded 80% and has continued to increase since then.

Going into launch, we expected to have strong support for Trodelvy within the academic breast cancer Centers of Excellence, evidenced by the rapid update of NCCN Guidelines to reflect the Trodelvy FDA approval. However, we have also been pleasantly surprised by the robust uptake of Trodelvy within the community oncology setting. Since the early launch, community hospitals and clinics have represented nearly 70% of the ordering institutions. During the first-two months of launch, there were over 500 accounts that have ordered Trodelvy.

Recognition of both the unmet need in triple-negative breast cancer and the strong Trodelvy clinical profile has also been reflected in the sense of urgency with which payers have been adopting formal coverage policies for the product. Having formal coverage policies in place with large payers removes barriers for treating physicians and paves the way for broad patient access. Time to review an implementation of a coverage policy will vary across different payers and across different disease areas.

As we have been monitoring the time to review metrics for Trodelvy during the first-two months of launch, we see that it is exceeding the performance of both breast cancer and broader oncology benchmarks. I'm happy to report that launch-to-date that trend has continued, with payers covering 70% of lives in the US market reviewing and adopting a Trodelvy coverage policy.

I'm also pleased to report that the quality of that coverage is equally impressive, with the vast majority of policies implementing a PA to PI position without major restriction. All this rapid payer progress, combined with a strong suite of patient support resources available through Trodelvy Access Services, has resulted in strong patient access to Trodelvy since FDA approval.

In summary, we are excited about the rapid uptake of Trodelvy since FDA approval and are happy that triple-negative breast cancer patients now have access to the first Trop-2-directed antibody drug conjugate within the oncology space. Furthermore, we believe that broader awareness of the ASCENT data at future medical conferences should continue to drive strong interest and contribute to our momentum.

Before turning it over to Loretta, I would like to extend another sincere thank you to all my Immunomedics colleagues for making this early launch a tremendous success.

Now Loretta will give you an update on our clinical program.

Loretta Itri -- Chief Medical Officer

Thank you, Brendan. The next months are going to be very busy and very exciting for us as we have two important studies to report and to file for regulatory approval. First and foremost is the confirmatory Phase III ASCENT study in metastatic triple negative breast cancer. Last month, we announced that this study met its primary endpoint of progression free survival in 468 brain metastasis negative mTNBC patients with a hazard ratio of 0.41 and a p-value of less than 0.0001.

Trodelvy also met key secondary endpoints, including overall survival and objective response rate. Importantly, the safety profile of Trodelvy in this study was consistent with the FDA approved label, and no new safety signals were observed. These impressive results will be submitted to this year's ESMO Congress as a late breaking abstract. Based on these data, we are in the process of compiling a supplemental biologic license application to be submitted to the FDA in the fourth quarter of 2020 that seeks full approval of Trodelvy. We also anticipate European submission of these data in the first half of 2021.

Another data set that we hope to present at ESMO is the TROPHY U-01 study in metastatic urothelial cancer. You may recall that at last year's ESMO, we reported an interim objective response rate of 29% in 35 patients who had failed prior platinum based therapy as well as a checkpoint inhibitor. We are now preparing to submit final results from the full cohort of 113 patients as a second late breaker abstract to this year's ESMO Congress.

As a reminder, earlier this year, FDA granted Trodelvy Fast Track designation for this indication. That designation, along with data from TROPHY U-01, can potentially form the basis of a biologics license application for accelerated approval of Trodelvy in metastatic urothelial cancer, subject to review by the FDA. Additionally, enrollment has commenced for cohort 3 that is studying the combination of Trodelvy and pembrolizumab. These cohort 3 patients are checkpoint inhibitor-naive and have failed a platinum-containing regimen in the metastatic setting.

Following the stoppage of enrollment due to COVID-19, we have recently resumed enrollment, and I'm pleased with the early pace of accrual. We are additionally pleased to announce that clinical sites for the registrational Phase III TROPiCS-02 study of Trodelvy in hormone response -- hormone receptor-positive HER2-negative metastatic breast cancer have resumed patient enrollment. While we are very pleased by the pace of accrual, which is almost back to pre-COVID levels, given that some regions are still facing a resurgence in new COVID-19 cases, we look to the period ahead to gauge whether there is any impact on trial sites before we commit to timelines for full enrollment.

With that being said, this study does include an interim look at objective response rate as well as duration of response from the subset of patients, the results of which to potentially support the submission for accelerated approval in 2021. This interim look was agreed with FDA prior to study initiation. We are also pleased that the open-label Phase II TROPiCS-03 study of Trodelvy in metastatic non-small cell lung cancer has very recently also resumed patient enrollment at select sites. This study will be expanded to include patients with squamous carcinoma of the head and neck later this year.

I'd like now to give an update on selected collaborative studies. Our collaborator at the University of Texas Health, San Antonio, Dr. Andrew Brenner, has submitted and received acceptance of an abstract for oral presentation at ESMO. This study is enrolling patients with either glioblastoma or brain tumors metastatic from breast cancer to evaluate the bioavailability of Trodelvy in the brain.

In this study, in addition to evaluating efficacy and safety, the team is measuring the levels of SN-38 and its metabolites in the tumor biopsy samples to enable a comparison to the serum concentration. The ratio will demonstrate the amount of Trodelvy that crosses the blood-brain barrier. Given that glioblastoma is an aggressive cancer with a very large unmet need, these results are obviously very important.

Another investigator-initiated study, the Phase II NeoSTAR study of Trodelvy in patients with localized triple negative breast cancer in the neoadjuvant setting has dosed first patients. As announced last month, we have expanded our ongoing collaboration with Roche to evaluate Trodelvy plus atezolizumab to include metastatic urothelial cancer and metastatic non-small cell lung cancer in addition to metastatic triple-negative breast cancer.

Also, Dr. Tolaney at Dana-Farber has launched two studies, combining Trodelvy with pembrolizumab in PD-L1 negative metastatic triple-negative breast cancer and in PD-L1 positive hormone responses, HER2 negative metastatic breast cancer. Finally, in China, our corporate partner, Everest Medicines, has launched a new single arm multicenter Phase IIb study of Trodelvy in third line, locally advanced metastatic triple negative breast cancer. Like Brendan, I would also like to thank my regulatory and clinical teams for their dedication in ensuring that our time lines and goals for ASCENT were met and as well as for the continued push in coming months. There is no rest for the weary, it seems.

I'll now turn the call over to Usama for a financial update.

Usama Malik -- Chief Financial Officer and Chief Business Officer

Thank you, Loretta. For the second quarter ended June 30, 2020, Immunomedics reported net product revenue of Trodelvy of $20.1 million compared to no product revenue for the comparable quarter ended June 30, 2019. The FDA granted accelerated approval for Trodelvy on April 22, 2020. Cost of goods sold was $1.7 million for the quarter ended June 30, 2020. There was no cost of goods sold for the comparable quarter ended June 30, 2019.

R&D expenses decreased by approximately $10 million to $42.6 million for the second quarter ended June 30, 2020, compared to the comparable quarter ended June 30, 2019, primarily due to a decrease in manufacturing and quality costs as all costs were expensed through research and development in the prior period, and a portion of such costs are capitalized in the current period due to FDA approval of Trodelvy. The decrease was partially offset by an increase in labor cost as well as clinical development and operational costs from expansion of clinical trials with increased enrollment.

SG&A expenses increased by $14.6 million to $28.9 million for the quarter ended June 30, 2020, compared to comparable quarter ended June 30, 2019, primarily due to increased labor costs from incentive and stock based compensation recognized upon FDA approval of Trodelvy in the United States, as well as increase in marketing and promotions costs in connection with commercial launch of Trodelvy. Net loss attributable to stockholders was $66.5 million or $0.30 per share for the quarter ended June 30, 2020, compared to $76 million or $0.40 per share for the comparable quarter ended June 30, 2019.

As of June 30, 2020, the company had $975 million in cash, cash equivalents and marketable securities as well as 231 million outstanding shares of common stock. This cash balance included a $60 million milestone payment from Everest Medicines for Trodelvy approval in the United States. We believe our projected financial resources are adequate to support our commercial launch of Trodelvy in the United States in metastatic triple negative breast cancer, continue to expand our clinical development programs for Trodelvy, investment in the broader clinical development of the ADC platform, continue to scale up manufacturing and manufacturing process improvements and general working capital requirements.

This summarizes our second quarter 2020 financial results. And now concluding remarks from Behzad.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thank you, Usama, Brendan and Loretta. Given that Trop-2 is widely expressed in a number of solid cancers, we have a robust clinical development program for Trodelvy, aimed at establishing it as a standard of care in triple negative breast cancer and broadening its potential use in other cancer types, advancing it to earlier line, either as a monotherapy or in combination with other agents.

We're excited to submit the supplemental BLA for Trodelvy in mTNBC for full approval in the coming months. And we look forward to presenting the comprehensive study results for ASCENT and final study results for TROPHY U-01, hopefully, at ESMO in a few short weeks. Further, we're highly encouraged by the data in mTNBC and the potential implications for the TROPiCS-02 study, where the control arm mirrors the ASCENT study exactly.

And with that, operator, please open up the call for questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question comes from Peter Lawson with Barclays. Your line is open.

Peter Lawson -- Barclays -- Analyst

Hi. Thanks for taking the questions. Just maybe a question initially for Brendan on the level of potential off-label use and levels of inventory or stocking orders?

Brendan Delaney -- Chief Commercial Officer

Yeah. Peter, how are you? As you would expect, we're promoting the drug within the labeled indication. And don't really have too much visibility into what's going on in the off-label and then won't comment on it.

Peter Lawson -- Barclays -- Analyst

And then maybe just on the level of inventory or stocking orders you think you've got in the quarter?

Brendan Delaney -- Chief Commercial Officer

With the type of drug and the type of distribution, I think we're in line with what you would expect for -- were relatively low levels of inventory.

Peter Lawson -- Barclays -- Analyst

Perfect. Thank you. And then maybe any details around any reimbursement pushback that you've seen or not, that would be great.

Brendan Delaney -- Chief Commercial Officer

Yeah. Peter, as I said in the comments, we've had very little pushback. And it's really been encouraging because I think on the payer side, you see the -- my slide portrayed the sense of urgency with which they're reviewing the product and also adopting a coverage policy, that they're doing that faster than the benchmarks, which is, I think, speaks to the unmet need and speaks to the impressive results that we've put forward in the overall clinical profile.

More importantly, the quality of access is as impressive. As I said, I think the -- there have been very few restrictions put in place. It's a PA to PI situation for most of them. For any restrictions that have put in place, they're very minor, for example, prior taxane or something like that. And that's kind of standard of care anyway in the treatment algorithm within triple negative. So very, very well accepted by the payer audience as well so far.

Peter Lawson -- Barclays -- Analyst

Great. Thank you. Just a final question. The initial patients, are they different in any way from the clinical trial setting?

Brendan Delaney -- Chief Commercial Officer

Hard for us to tell. The patient level data, we don't necessarily have right now. So really hard to comment on that.

Peter Lawson -- Barclays -- Analyst

Great. Thanks, guys. Congrats on the first quarter. Take care.

Brendan Delaney -- Chief Commercial Officer

Thank you very much, Peter.

Operator

Thank you. Our next question comes from Phil Nadeau with Cowen. Your line is open.

Phil Nadeau -- Cowen -- Analyst

Good afternoon. Congratulations on the progress and thanks for taking my questions. Just a couple on the pipeline. You mentioned the TROPHY U-01 data that's going to be coming at ESMO. Based on the information you have, are there any major differences in the patient characteristics between the 35 patients in the interim versus the 113 in the full data set? Anything that could bias the results one way or the other?

Loretta Itri -- Chief Medical Officer

No. The two sets of data appear very, very similar in terms of patient characteristics, and certainly anything that we can see as differentiated.

Phil Nadeau -- Cowen -- Analyst

Great. That's helpful. And then second, on the TROPiCS-02, is there any update on when you would anticipate the interim analysis? And maybe diving into that interim in a bit more detail. Have you ever disclosed the number of patients who will be included in the interim, in the powering for ORR that is built into the study design at the interim?

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

We haven't disclosed that, Phil. Hi. It's Behzad here. We haven't disclosed the number of patients. I think what's important to know is we need to hit that number of patients, but then we also need a follow-up period that you should assume generally is on the order of six months plus as a duration of response assessment. So if you add that all together, I think it's too early to tell definitively. But we did provide clarity today that if data warrants, then it would be the basis of an acceptable filing in 2021.

So if you work backwards from that, I think we'll be certainly have -- report the data sometime in the first half of next year. And if we could move it any sooner, we would certainly do that. Not perfect to know exactly when that will occur, but we're observing it and knowing when that can occur.

Phil Nadeau -- Cowen -- Analyst

Perfect. That's all. Thanks again for taking my questions.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thanks, Phil.

Operator

Thank you. Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.

Joe Catanzaro -- Piper Sandler -- Analyst

Hey, guys. Thanks so much for taking my questions and congrats on the strong start here. Maybe first, and recognizing that we've only seen top line ASCENT data. Just wondering if you've seen any impact then in terms of prescribing patterns and usage since the top line readout in early July. And wondering if there's any opportunity with the filing around those data to have a discussion with the FDA around changing in the language and the label around prior treatments, but again understanding that ASCENT is the same population as the accelerated approval?

Brendan Delaney -- Chief Commercial Officer

Yeah. So Joe, this is Brendan. I'll answer the first question. It's really hard to parse out the impact. I mean we're on a pretty strong growth trajectory to try to parse out. I would expect -- as I said, I would expect a bit of a tailwind when the actual data is presented and publication -- subsequent publication, that I would expect to see continued momentum. But in the early part here, we've been impressed overall with the growth and the trajectory. And it's hard to parse out what that -- what's driving that, whether it's the announcement or just general excitement for what is a very impressive drug.

Joe Catanzaro -- Piper Sandler -- Analyst

Okay. Thanks. Any thoughts around opportunity for maybe having a discussion around the language in the label indication with ASCENT, again understanding that there's some early line usage potentially ongoing, the available therapies in the second line setting? Just any thoughts there?

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Yeah. That's a little hard to comment on, especially given that it would be a regulatory dialogue. We certainly wouldn't comment on anything ahead of it -- discussion. But let us first get this data to the FDA, make sure we get the label fully updated. And if there's an opportunity to have those kinds of discussions, I'm sure it will come up. But I'd rather not comment on any regulatory strategy.

Joe Catanzaro -- Piper Sandler -- Analyst

Okay. Sure, fair enough. I just want to follow-up also on Phil's prior question in TROPiCS-02. I know you guys are guiding to a potential accelerated filing in 2021 and Behzad, you just noted that data potentially in the first half of next year. Have you guys already enrolled the number of patients required for that interim ORR to occur? And just, so again understanding that there's some durability of any follow-up required for that interim to occur.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Joe, without going to blow-by-blow, I think given that we're giving the general guidance that we feel comfortable, when we are going to report that and we can file it, I think you can assume if we haven't reached it, we're very close, but we might have reached it as well. I really don't want to get into where we are exactly on enrollment.

Joe Catanzaro -- Piper Sandler -- Analyst

Okay. That's helpful.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

I've seen your staff modeling skills. I'm worried.

Joe Catanzaro -- Piper Sandler -- Analyst

What was the gross to net in the quarter and any guidance around that moving forward? Thanks.

Usama Malik -- Chief Financial Officer and Chief Business Officer

Sure. Hey, Joe. This is Usama. Listen, I'm sure you'll read the queue and see the footnotes there. But our guidance remains in the 15% to 20% range. It's early days. These are our best assumptions based on industry comparables and as we get that better data, the gross to net will continue to get refined over time.

Joe Catanzaro -- Piper Sandler -- Analyst

Okay. Got it. Thanks so much for taking my questions and congrats again on the quarter here.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thank you, Joe.

Operator

Thank you. Our next question comes from Tazeen Ahmad with Bank of America. Your line is open.

Tazeen Ahmad -- Bank of America -- Analyst

Thanks so much for taking my questions. Maybe one on non-small cell lung cancer. Based on where you are today, Behzad, when could we expect to see some data from this study? And can you also just give us your thoughts about -- it's hard to see when apples-to-apples comparison, but how would you think about the profile of your drug versus the Daiichi drug, for example, both in terms of efficacy and safety? And then I'd also just like your thoughts about the deal that was announced, expanding the relationship that Astra has to include this particular Trop-2.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Sure. On timing of data, I think, Tazeen, that study is the one that we've most recently turned back on as -- following the shutdown of all our enrollments for -- due to COVID. And so that's unlikely to be certainly a 2021 event in terms of the data from that study. In terms of the comparison, on the efficacy side, if you follow the trajectory of the 1062 efficacy from ASCO to World Lung and then ASCO update just recently, I think you'll see a very similar trajectory to what our results were, where we started substantially higher response rates.

And I think we finally landed in the high teens, 19% or so. Toward the publication, I think they're in the low 20%. So it looks pretty comparable. We haven't seen a follow-up for them to get any sense of duration. And the only other key differentiator, which we've always maintained as important, as you think about earlier lines in combination setting is a safety profile. And there, there's clear differentiation where we've, I think, only had one case of ILD in the 500 or so basket study.

Phase I and the data in ASCENT will come out soon at ESMO and you can judge the safety profile. But there was nothing that whatsoever suggests we have an ILD signal or any major side effects that would be irreversible and/or potentially, frankly, life-threatening, And I think they have most recent data set. They disclosed two Grade 5 ILD and across doses of 4, 6 and 8 mgs per kg. So I think from a safety profile, it's really pretty clear that we have a different safety profile and one that lends itself to, first of all, superior safety when it comes to single agent, but most certainly in a combination setting.

With respect to the collaboration with AstraZeneca, I can't really comment on that. I mean I think you saw the deal terms, you saw the stage of development, and I think we just feel generally very pleased with where we are in terms of first approval, follow on with ASCENT and multiple indications, registrational to come. Yeah, I'll just leave it there.

Tazeen Ahmad -- Bank of America -- Analyst

Okay. And what are your thoughts on additional collaborations? You've obviously got what looked to be pretty fruitful ones with Roche and Merck, among others. Are you of the view that the more, the merrier or do you think you have enough collaborations for now?

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

So I think we've sort of covered, by and large, the key basis with respect to the settings of earlier line all the way up to front-line, even in some instances, neoadjuvant settings. And then also covered many of the bases with respect to both checkpoint combinations and parts and P1 and PD-L1 as well as in PD-L1 positive and PD-L1 negative patients. So I think if you sort of think of it as a three dimensional matrix, we've almost covered every quadrant with respect to signal finding, in some instances, maybe registration enabling studies. And I don't think there's a tremendous need on our part to pursue additional combinations.

But at the other hand, if a pharma partner were to step forward and provide attractive terms to us, our terms and all our collaborations are very favorable to us, Immunomedics, it really only improves our ability to touch more patients and identify more opportunities. And if such opportunities were to present themselves, we'd certainly entertain them. But as far as, our main objective has always been to identify all the areas we need to assess and then ultimately figure out which will be worthy for the registrational studies. Those are obviously costly and would not be what I would call sort of collaborations or loose collaborations the way we entertain them until now. And how we go about funding those and collaborating with those, that's a different topic.

Tazeen Ahmad -- Bank of America -- Analyst

Okay. And then maybe one finance question or financially related question. What do you ultimately expect the payer mix to be for triple negative between government and commercial?

Brendan Delaney -- Chief Commercial Officer

Yeah. This is Brendan, Tazeen. Our estimates still are the same, but 55% commercial, 30% to 35% Medicare. The mix is a little different than other tumor types because of the relatively young age of the population in triple-negative breast cancer.

Tazeen Ahmad -- Bank of America -- Analyst

Okay. Thank you.

Operator

Thank you. Our next question comes from Michael Schmidt of Guggenheim. Your line is open.

Michael Schmidt -- Guggenheim -- Analyst

Hey, guys. Congrats on the Trodelvy launch and thanks for taking my questions. I had a couple. Maybe first on the launch itself, I was wondering if there was some kind of pent-up demand or a patient bolus in the second quarter. I'm just thinking about sort of the trajectory over the remainder of the year if there is some more steady patient flow going forward or if there was some kind of bolus upfront that helped in the second quarter.

Brendan Delaney -- Chief Commercial Officer

It's hard to tell. Michael, this is Brendan. Hard to tell. I think people generally assume that there's a bolus. However, in triple negative, I think there's -- because of how devastating the diseases and how rapidly patients progress, I'm not sure -- I think there were patients waiting, but I'm not sure, if it's built up to be a tremendous bolus, as you described. Also based on -- it's been pretty consistent growth since day one, and it's hard to identify anything in the pattern that would suggest that at this point. It's early, but it doesn't necessarily look like you're seeing a traditional bolus type of launch curve.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

And Michael, had there been any -- I think it would have been more than offset by the fact that some regions of the country, for the early part of the launch due to total lockdown, including the cities [Indecipherable] I guess. Now I know you're in Boston. I didn't realize of it. Cities like New York, some major cancer centers were -- did not come alive until much later into the quarter because of the COVID pandemic. So I think if there had been a bolus, it certainly was more than offset by that dynamics.

Michael Schmidt -- Guggenheim -- Analyst

All right. That makes sense. Thanks. And then couple on the pipeline. Maybe first on urothelial cancers with that data coming up here soon and, I guess, in third line patients. Just wondering how you see the drug positioned relative to Celgene's part as an initial indication? I'm not sure if you've done any market research in terms of its potential use relative to that.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Let me -- Brendan, can you...

Brendan Delaney -- Chief Commercial Officer

Yeah. I can comment first, Michael. We've done a lot of work with GU docs, who treat bladder cancer. Obviously, Padcev is a good product. We're happy for patients to have such a strong treatment option in the space, first of all. They're out to a lead moving up in the earlier lines of therapy, which I think is advantageous for us because that means there's room for us to grow earlier. I do think our profile is differentiated. Certainly, we expect strong efficacy, but we also expect with our safety profile, and specifically what we don't have, peripheral neuropathy and some of the other different limiting side effects.

I think we will have a place to play -- strong place to play in bladder cancer therapy. As more options come out, therapy gets more individualized instead of a cookie-cutter approach, and that's the way physicians see it going forward. So based on the patient's characteristics and what they're presenting with, one option may be better than the other first. But certainly, whatever is used first doesn't preclude the other product from being used second.

So all in all, I think we're pretty -- very excited about our differentiation within the space and our competitive position. But as I said, I think it's all positive for patients to have multiple options across multiple lines of therapies.

Loretta Itri -- Chief Medical Officer

Like I said...

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Clinically -- Loretta, what -- you want to comment on clinical?

Loretta Itri -- Chief Medical Officer

Clinically, there -- as Brendan has already said, I think everyone is very excited in this area where there has not really been a major breakthrough for a very, very long time that we suddenly have two major new products available for the treatment of this population that is greatly in need. And as Brendan has also alluded to, these products don't appear to have cross-resistance. We have had patients in our studies that have received enfortumab and have done well on it and then gone on to progress and then have done well on sacituzumab. So I think that there's room certainly for both of these products.

I think the other thing that we're hearing a lot from the clinic is that these two products have very different side effect profiles. Enfortumab has -- just a different set, more ILD that is something of a concern, and neuropathy, which is something of a concern, whereas we are primarily neutropenia and diarrhea, and we have always been neutropenia and diarrhea. And it looks like we're going to stay in the neutropenia and diarrhea. So it's just a different population.

And so if you're managing patients, if someone comes in with a platinum-based neuropathy to start or is diabetic and has diabetic nephropathy or neuropathy, you're going to pick a drug that is more suitable for that patient from the side effect profile. So again, we are very, very excited to have both drugs available, and we think that there's going to be lots of benefit for patients because of their nonoverlapping toxicity. We are even examining, in some studies, the possibility of putting the two drugs together. But it's way too early to talk about what that might look like.

Michael Schmidt -- Guggenheim -- Analyst

Yeah. And then just a question on the bigger picture development plan in urothelial cancers. I know you have a couple of studies ongoing or planned now in combination with PD-1 inhibitors, with Roche and then with Keytruda. And both of those are into the post-platinum, in a second line setting. I was just wondering, number one, if those studies are -- especially the cohort 3 Keytruda combination, if that is something that could potentially be turned into a registration -- a single arm registration study and how you think about the opportunity maybe in first line or even neoadjuvant setting longer term?

Loretta Itri -- Chief Medical Officer

It's so very early for us to be in making any kind of regulatory plans around it. But yes, I mean, I believe, ultimately, Trodelvy belongs farther upfront. I think after talking with the leadership of the community, that is the general feeling. And when it goes upfront, it's probably going to go in combination. So I think time will tell, but there's certainly nothing about Trodelvy in terms of its toxicity profile that prevents it from being brought upfront or being used in combination.

Michael Schmidt -- Guggenheim -- Analyst

Okay. And then one last question. I have to ask my TROPiCS-02 statistics question as well. So I guess my question is really around the control arm. And I guess the question is you didn't have the full ASCENT data, especially on the control arm at the time of the -- powering of the TROPiCS-02 study, including your interim analysis. And I was just wondering if you could provide any additional comments on your thinking at the time as to how the control arm might have performed in an absence of large data, especially around response rate or PFS.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Well, I'll take that one. I think the control arm of ASCENT, we generally thought would be high-single digit, low-double digit. And in terms of response rate, and you'll get to see yourself what that number looks like, but I think the PFS already tells you that number you already know for the control arm of ASCENT, that I think literature might have overstated what to expect in a randomized setting in this very late-line patient population.

Now what's also remarkable on the -- again, on data that now we've disclosed, how similar Trodelvy performs in ASCENT versus our Phase I study. And I think, generally, our collective view would have been, I imagine you'd share that opinion, that a Phase III study generally deteriorates versus a Phase I/II site study, but Trodelvy has recapitulated in triple negative breast cancer the data from the Phase I and on the first 35 patients in urothelial cancer. It also recapitulated, post checkpoint, what we previously reported in the more mixed patient population.

And now we have a control arm that is identical between this study and TROPiCS-02 and a late-line patient population that I think also is going to be so heavily refractory that while we generally hear from our KOL community to expect high-single digit, low-double digit, maybe up to 15% of response in chemo, there's really no evidence to support that, that once a patient has experienced monotherapy, then CDK406 and two other chemos, the question to the clinicians is, Well, what's left?

And if they say, well, we would use eribulin, well, sure. But here is a patient that just saw eribulin, triple negative, different disease, a little bit slower progressing, generally saw. But after so many lines of therapy, once they're confronted with that sort of thinking, their view is that the TROPiCS probably won't be that different to ASCENT, at least not the performance in the chemo RR.

And again, you don't have to wait that much longer until ESMO to see what the response rate comparisons look like. And you can then use your statistical tools, Michael, to make your probability adjustments. But I think from a patient trial study design standpoint, from a powering standpoint, I think we feel pretty good about TROPiCS-02.

Tazeen Ahmad -- Bank of America -- Analyst

Okay. Thanks for all those detailed answers. Really appreciate it.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Sure. Thanks.

Operator

Thank you. Our next question comes from Jim Birchenough of Wells Fargo Securities. Your line is open.

Nick Abbott -- Wells Fargo Securities -- Analyst

Good afternoon. It's Nick on for Jim and congratulations on a splendid launch, and a long time coming. The first question is, how important do you think the Phase III ASCENT result is to the overall message on to Trodelvy? I guess another way is, are there a group of physicians out there who would be slow to adopt this without a positive Phase III confirmatory trial? And if that's the case, are you considering a Phase III confirmatory trial in a late line urothelial cancer?

Brendan Delaney -- Chief Commercial Officer

How are you doing, Nick. This is Brendan. Yeah. So I think the ASCENT data will be very meaningful within the market. The reason I say that is for people who are slow physicians, I mean who are slow to adopt, there is a perception of a survival advantage with how have been in the third line setting based on, I believe, a retrospective analysis. So certainly coming with a Phase III prospective trial, reporting the data that we have, then subsequently updating the prescribing information, we'll have a strong impact in the market. So a long way to answer your question. But yes, certainly, we'll have a, I think, a large impact in the market.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

And Nick, I'll add to that, though. I think triple negative per se, I personally I'm not so convinced that it's going to have a day and night effect. Brendan and I would go back and forth on this, but I always say what else would a physician prescribe in that indication, we all have said for many years, there's no prior treatment option. But I think it is important in, when you sequence it versus other agents because eribulin has generally been considered to have a survival benefit. And so having a survival benefit, I think, is additive here. And so it takes away the one reason why someone may not want to prescribe Trodelvy ahead of -- at least the patients seeing eribulin, if they hadn't seen it previously in the prior line setting.

But I think the far more important component here is, it's going to make it very hard for anyone else to enter the space, number one, because you have a survival advantage, and that is still the gold bar, especially the survival advantage is meaningful, clinically meaningful. But importantly, also in Europe and other jurisdictions, survival is a very important endpoint from a pricing standpoint. And while the US is, generally from that regard, from the approval and the reimbursement standpoint, in Europe, this is a very meaning development for the company.

Nick Abbott -- Wells Fargo Securities -- Analyst

Thank you. And so just on urothelial cancer, do you need to follow the same playbook?

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

I think Loretta commented. But my opinion is that once you have clear differentiation and there'll be other studies that are going to read out before a -- compared to one study, a Phase III randomized study of urothelial, would read out, we'd have probably TROPiCS-02 having read out. And if it -- I mean, I think, at some point, the incremental data, while it's still important, it's probably not going to be as surprising or impactful because people will obviously become very aware of the data that we've generated from ASCENT and, hopefully, from other studies that were -- in the interim. But specifically the urothelial having an overall survival endpoint, Loretta, how critical that is?

Loretta Itri -- Chief Medical Officer

I think it's always important to have survival. I mean it is the gold standard of clinical trials, but I don't think it's going to stop anyone from using a drug that has clear benefits, response rate, progression free survival, duration of response, all valuable pieces of information. And people were prescribed on the basis of that. Additionally, with the safety profile of our drug, given the limited available treatments that we have for these advanced patients, I don't think anyone's going to hold back from using Trodelvy in that -- the appropriate setting.

Nick Abbott -- Wells Fargo Securities -- Analyst

Thank you. And then last for me. Can you provide us some comments on product supply, Behzad, and also timing of the switch to Samsung?

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

I won't really comment in any more detail from what we've said previously, but we are working and continue to work feverishly to bring Samsung online. And we'll give the update if there is one to be provided. But at this point, we have product supply out of New Jersey, and we feel pretty good about where we are. But we need Samsung to come alive, and that's looking promising, as I've said. And as long as it comes online in a time frame that we needed to, we will be very well-off, if you will, and so far so good.

Nick Abbott -- Wells Fargo Securities -- Analyst

Thank you and congratulations on a splendid launch.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thanks very much.

Operator

Thank you. Our next question comes from Chris Howerton of Jefferies. Your line is open.

Chris Howerton -- Jefferies -- Analyst

Great. Thanks so much. And I'll also offer my congratulations on a longtime coming launch, so great to see. I guess for Brendan, maybe just a couple of questions for you, and then I suppose a question for Behzad. With respect to the launch, do you get any sense -- I understand that it's early, but what kind of reordering are you seeing from the institutions that have already ordered? I think you said 500, and then secondarily -- go ahead, I'm sorry.

Brendan Delaney -- Chief Commercial Officer

No, sorry. Yeah. No, it's -- the reorder pattern is very high, very high.

Chris Howerton -- Jefferies -- Analyst

Okay. Excellent. Okay. And then the other I just found intriguing was that in this virtual environment, typically, medical education tends to occur associated with conferences. So just curious if you could describe somewhat of that strategy to access the medical professionals in the more virtual environment and any learnings that you've had along the way?

Brendan Delaney -- Chief Commercial Officer

Yeah. Listen, it's mostly been positive, and then there's been a lot of surprises. I think engaging healthcare professionals in this virtual way is here to stay, even hopefully post COVID. It's a lot more efficient in many ways. And so I've been really impressed. I think sometimes, it takes a little more work. In a program -- live program that you may have 10 people on, you may have a one-on-one or so. Just you have to do more of them, but people are engaged. I think when you have a strong product like this, people want to learn about it. So that's certainly works in our advantage.

I think we've done a lot. We changed the marketing mix, Chris, like anticipating COVID and put things like more national broadcast with key opinion leaders in breast cancer who have experience with the drug. So we just increased the number in those ways. But certainly, in many -- the execution, for example, of some of our early speaker programs, our sales team has done a great job with that.

But in many ways, we got them started earlier because the lead time that you need to plan a live program, you just don't need for a virtual program. So a physician, theoretically in New York, who has experience with the drug, can educate group of physicians in Florida almost real time. But I don't think it could be set up very quickly. So those things have been learnings on a positive side. Obviously, working through COVID is not an ideal situation, but certainly some learnings that are here to stay.

Chris Howerton -- Jefferies -- Analyst

Okay. All right. Fantastic. And for Behzad, clearly, we understand, or I understand, that the focus is on Trodelvy at the moment. But I'm intrigued in terms of some of the commentary on use of proceeds to fund 130 and 140, some of the other pipeline assets further down the line. So just curious when and if we might expect any updates from those earlier-stage programs?

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Yeah, sure. I think it's going to be some time. Most of the effort will have to be on the manufacturing side of those agents before we can put them into the clinic. So I think just given the lead time of the manufacturing ADC, conjugation, etc., and then putting into patients, it certainly is not something that is going to be a very near-term event. But you have to plant those seeds, and when the right time comes, we pick the fruit.

Chris Howerton -- Jefferies -- Analyst

Understood. Okay. And then maybe a quick one for Usama, just perhaps what we can expect in terms of additional milestones from your collaboration with Everest? And maybe some fence around -- some time lines in terms of when we might expect some updates from that site.

Usama Malik -- Chief Financial Officer and Chief Business Officer

Sure. So as in this previous quarter, we did receive the $60 million milestone payment on the FDA approval from Everest. If you recall, the total milestones around development and sales totaled to around $710 million. Those are based on launch of the various trials, participation in global trials, first patient in, regulatory approval in different countries. And those details were 8-K when we did those -- when we completed that contract.

And there's a number of milestone payments associated with sales and sales milestones as the product gets commercialized in various markets. And then last but not least there, the royalty milestones ranging anywhere between 14% and 20% depending on various provisions [Phonetic] of revenue brought in. I think that's kind of the totality of what those milestones look like. There's a lot of detail there, which we obviously can't expand on in this call, but I think that should give you a good indication.

Chris Howerton -- Jefferies -- Analyst

Sure. Okay. Well, thanks so much and again, heartfelt congratulations to you all, and really glad to see the progress.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thank you very much.

Usama Malik -- Chief Financial Officer and Chief Business Officer

Thanks, Chris.

Operator

And our next question comes from Paul Choi of Goldman Sachs. Your line is open.

Paul Choi -- Goldman Sachs -- Analyst

Hi. Thank you. Good afternoon, everyone. And let me offer my congratulations on the great early launch as well. My first question is for Loretta. And I was wondering if you could maybe help us understand what the timing might be for a potential update in terms of your ongoing biomarker analysis across the various tumor types on Trop-2? And whether you expect any difference or how to think about potential differences between the metastatic and neoadjuvant populations?

And then my second question is for Brendan. Just on the penetration into the various settings, could you maybe comment a little more on just what academic center utilization has been? I know those typically take a little bigger to get through P&T and so forth. But just sort of where you are in terms of targeting and how many of your target centers have adopted or utilized the drug? Thank you.

Loretta Itri -- Chief Medical Officer

Okay. So I'll start with Trop-2 because I don't have much to tell you. We obviously, finally, have a large enough collection and a validated assay with which to assess Trop-2 levels. I think that we are in the process of analyzing those data now from ASCENT, and I don't have much to tell you about it. Of course, the ASCENT population was very advanced population. And I think it will be a long time before we are able to extrapolate whatever findings we have from that population to an earlier population.

There's very little information actually about Trop-2 expressions. We don't know how it evolves over the lifetime of the tumor. We don't know if patients start out with high Trop levels and stay that way. So there is -- there are many, many more questions about Trop-2 as a target than there are answers. And I think it's going to take us some time to even figure out in the advanced setting exactly what the message is. So that's all I can say about Trop-2 right now.

Paul Choi -- Goldman Sachs -- Analyst

And anything else on other solid tumor types?

Loretta Itri -- Chief Medical Officer

I think they're all in the same boat, frankly. For us, we have -- we're going to have much more data in breast because we have more samples. And we'll have a cohort from the urothelial group as well. And we'll take a look at all of it and see if we can draw or extrapolate between the populations. But again, these are very advanced patients. These are bank samples, and it's going to be very difficult, I think, to draw specific correlations.

Brendan Delaney -- Chief Commercial Officer

Paul, on your second question on uptake in the academic and that kind of split. I mean we've been pretty impressed with the uptake across both settings. I mentioned, specifically in the community oncology setting. And usually, we expect the academics to come on because they have a clinical trial experience. But we've seen robust across the academic and community.

What's interesting in the academic side is, COVID had an impact there on the ability for different institutions on the academic side to even meet and have a formulary review and a P&T meeting and that type of thing. So that was kind of interesting to see unfold because it did create a bottleneck early. However, a lot of that has resolved since.

And certainly, broadly speaking, I think the uptake in the academic setting is very strong. And from what we hear from feedback from the physicians in the academic world, they're very impressed with the profile of the drug. So some slight bumps in that area with COVID, but I think we've managed to work through them so far.

Paul Choi -- Goldman Sachs -- Analyst

Great. That's helpful color. Thank you again and congrats on the quarter.

Brendan Delaney -- Chief Commercial Officer

Thank you, Paul.

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Thanks, Paul.

Loretta Itri -- Chief Medical Officer

Thank you.

Operator

At this time, I'd like to hand the conference back over to Chau Cheng for closing remarks.

Chau Cheng -- Senior Director, Investor Relations

On behalf of the entire leadership team, I'd like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.

Operator

[Operator Closing Remarks]

Duration: 63 minutes

Call participants:

Chau Cheng -- Senior Director, Investor Relations

Behzad Aghazadeh -- Executive Chairman of the Board of Directors

Brendan Delaney -- Chief Commercial Officer

Loretta Itri -- Chief Medical Officer

Usama Malik -- Chief Financial Officer and Chief Business Officer

Peter Lawson -- Barclays -- Analyst

Phil Nadeau -- Cowen -- Analyst

Joe Catanzaro -- Piper Sandler -- Analyst

Tazeen Ahmad -- Bank of America -- Analyst

Michael Schmidt -- Guggenheim -- Analyst

Nick Abbott -- Wells Fargo Securities -- Analyst

Chris Howerton -- Jefferies -- Analyst

Paul Choi -- Goldman Sachs -- Analyst

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