Chau Cheng: Thank you, Noma. Good afternoon everyone and 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 IR page. With us on the call today are Dr. Behzad Aghazadeh, Executive Chairman, who will give us quick overview of the quarter; Brendan Delaney, Chief Commercial Officer, who will provide early commercial uptick commentary and metrics; Dr. Loretta Itri, Chief Medical Officer, who will walk us through clinical development priorities and upcoming update; and Usama Malik, Chief Financial Officer and Chief Business Officer, who will provide you with an overview of our financials 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 and therefore actual results could differ materially from those expressed or implied on this call. Factors that could cause such a difference include the uncertainty associated with pharmaceutical development and 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 with 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.
Dr. Behzad Aghazadeh: Thanks you, Chau. Good afternoon everyone and thank you for joining. Second quarter 2020 was transformative for Immunomedics. In particular, we reached an important milestone of receiving our first ever drug approval from the FDA and we're able to launch Trodelvy in the U.S. within one week of FDA's accelerated approval. Currently, we delivered on our promise report, top line results from the confirmatory Phase 3 ASCENT study in mid-2020. And the results clearly demonstrated significant benefits to the 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 toward growth trajectory. And finally, as the world continues to contend with the challenges presented by the COVID-19 pandemic 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're still early in our launch, it is clear that Trodelvy has been well received by patients under treating physicians alike in only two short months since approvals, we achieved $20.1 million in net sales. I would like to thank Brendan and his hard commercial team for pulling off a great starts. 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 3 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 end points 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 relapse 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 to Trop-2 as a target for cancer treatment process. Trodelvy has a unique and differentiated safety and efficacy profile. That is distinct from other ADC 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 early align and combination. Loretta will provide you with a more comprehensive update about 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 to-date.
Brendan Delaney: 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 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 22nd, our launched has been driven by three strategic imperatives. First, we need to quickly establish Trodelvy as the standard of care after prior treatment 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 health care providers to ensure a positive 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 seem consistent with what has previously been observed in the clinical trial setting. Lastly, 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 drugs 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 share days, hours and even minutes off the drug availability timeline. Despite the headwinds that marching within a COVID-19 pandemic have presented, our team never wavered and never lost focus. Their execution started with trodelvy.com going live within hour, quickly followed by representatives, educating prescribers within 24 hours and peer-to-peer education programs being executed during the first week on the market. Launch to-date over 1,000 healthcare providers in the United States have attended a Trodelvy education events. 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 express a comfort with managing patients on therapy. Although early market share estimates can be unreliable, recent market research conducted with community of oncologists in the U.S. 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 represents 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 of 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 paved the way for broad patient access. Time to review and implementation of a coverage policy will vary across different payers and across different disease area. As we have been monitoring the time for review metrics, which Trodelvy during the first two months of launch, we see that it is exceeding the performance of both breast cancer and oncology benchmarks. I am happy to report that wants to date that trend has continued with payers covering 70% of lives in the U.S. market reviewing and adopting a coverage policy. I am 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 restrictions, 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 interests 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 to give you an update on our clinical program.
Dr. Loretta Itri: Thank you, Brandan. 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 a confirmatory Phase 3 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 rates. 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 abstracts. Based on these data, we are in the process of compiling a supplemental biologic slice this 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 it last year ESMO we reported an interim objective response rate of 29% in 35 patients who had failed prior platinum based therapy, as well as the checkpoint inhibitor. We are now preparing to submit final results from the full cohort of 113 patients as the second late breaker abstract to this year as 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 and metastatic urothelial cancer subject to review by the FDA. Additionally, enrollment has commenced for cohort 3 that is in studying the combination of Trodelvy and pembrolizumab. These cohort 3 patients are checkpoint inhibitor naive, and failed the platinum containing regimen in metastatic setting. Following the stoppage of enrollment due to COVID-19, we have recently resumed enrollment and I am pleased with the early pace of accrual. We are additionally pleased to announce that, the clinical sites to the registrational Phase 3 TROPiCS-02 of Trodelvy and hormone response in 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 level, 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 a subset of patients, the results of which could 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 2 TROPiCS-02 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 the acceptance of an abstract for oral presentation at ESMO. This study is enrolling patients that 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 SM-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 2 NeoSTAR steady 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. Delaney as Dana-Farber has launched two studies combining Trodelvy with pembrolizumab in PD-L1 negative metastatic triple-negative breast cancer and in PD-L1 positive hormonal responses HER-2 negative metastatic breast cancer. Finally in China, our corporate partner, Everest Medicine has launched a new single-arm multicenter Phase 2b study of Trodelvy in third line locally advanced or metastatic triple negative breast cancer. Like Brendan, I'd also like to thank my regulatory and clinical team for their dedication in ensuring that our timelines and goals were met and as well as for the continued push in coming months. There is no rest for the weary its seeing. I will now turn the call over to Usama Malik for financial update.
Usama Malik: Thank you, Loretta. For the second quarter ended June 30, 2020, Immunomedics reported net revenue for 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 end, June 30, 2020. There was no cost of fiscal 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 at all costs for expensive research and development in the prior period and a portion of such costs for capitalizing the credit period to FDA approval for Trodelvy. The decrease is partially offset by an increase in labor costs as well as clinical development and operational costs from expansion of clinical trials with increase enrollment. SG&A expenses increased by 14.6 million to 28.9 million for the quarter ended June 30, 2020 compared to the 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 the commercial launch of Trodelvy. Net loss attributable to stockholders were 56.5 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 equivalent and marketable security as well as 231 million outstanding shares of common stock. This cash balance included a $60 million milestone payment from Everett medicine for Trodelvy approval to the United States. We believe our projected financial resources are adequate to support our commercial launches Trodelvy in the United States and metastatic triple negative breast cancer continues to extend our clinical development program for Trodelvy, invest in the broader clinical development of the ADC platform, continued to scale up manufacture and manufacturing process improvement and general working capital requirements. This summarizes our second quarter of 2020 financial results and now concluding remarks from Behzad.
Dr. Behzad Aghazadeh: 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 and that establishing it as a standard of care in triple negative breast cancer and broadening its potential use in all the cancer types, advancing it to order lines either as a monotherapy or in combination with other agents. We’re excited to submit the supplemental BLA for Trodelvy and mTNBC for full approval in the coming month and we look forward to presenting the comprehensive study results for a sense 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 for the control arm mirrors the ASCENT study exactly. And with that, operator, please open up the call for questions.
Operator: Thank you. [Operator Instructions] Our first question comes from Peter Lawson with Barclays. Your line is open.
Peter Lawson: Hi. Thanks for taking the questions. Just maybe a question initially for Brandan on the level of potential off-label use and levels of inventory of stock in orders?
Brendan Delaney: Yes. 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: And then maybe just the level of inventory or stock in orders you think you got in the quarter?
Brendan Delaney: The type of drug and the distribution, I think we're in line with what you'd expect for relatively low levels of inventory.
Peter Lawson: Perfect. Thank you. And then maybe any details around any reimbursement pushback that you've seen or not, that would be great?
Brendan Delaney: Yes. You know what, 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, my slide portrait 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 I think speaks to the unmet need and speaks to the impressive results that we put forward in the overall clinical profile. More importantly, the quality of access is as impressive as we said. I think there've been very few restrictions put in place at the 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: Great. Thank you. Just a final question. The initial patients, are they different anyway for clinical trial setting?
Brendan Delaney: 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: Great. Thanks guys. Congrats on the first quarter.
Brendan Delaney: Thank you very much.
Operator: Thank you. Our next question comes from Phil Nadeau with Cowen. Your line is open.
Phil Nadeau: Yes. Congratulations on the progress and thanks for taking my questions. Just a couple on the pipeline, you mentioned the TROPHY U-01 data is 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 dataset, anything that could bias the results one way or the other?
Dr. Loretta Itri: The two sets of data appear very, very similar in terms of patient characteristics and certainly anything that we can see as differentiating.
Phil Nadeau: 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 instrument a bit more detail? Have you ever disclosed the number of patients who'd be included in near term in the powering for ORR that is built into the site design at the interim?
Brendan Delaney: We haven't disclosed that Phil. It's Behzad here. We have disclosed a number of patients. I think it was important to know we need to hit that number of patients, but then we also need a follow up areas that you just assume generally is on the order of six plus month 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, it would be the basis of an acceptable filing in 2021. So, if you work backwards from that, I think we will be certainly as reported date sometime in the first half of next year, and if we could move it as soon as we would certainly do that, not perfect to know exactly when that will occur, but we're zeroing in or knowing when that can occur.
Operator: Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.
Joe Catanzaro: Hey guys. Thanks so much for taking my questions and congrats on the strong start here, maybe first in recognizing that we've only seen top line data, just wondering if you've seen any impact in terms of prescribing patterns and usage since the top line readout and 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 the language and the label around prior treatment, but again understand if that was the same population as the accelerated approval?
Brendan Delaney: 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. You try to part that 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 party or we've been impressed overall with the growth and the trajectory and target part that what that's, what's driving, whether it's the announcement or just general excitement for what is a very impressive drug.
Joe Catanzaro: Okay. Thanks. Any thoughts around opportunity for maybe having a discussion around the language in the label indications, with the sense again, understanding that there's some early line usage potentially ongoing the available therapies in the second line setting. Just any thoughts there?
Brendan Delaney: That's a little hard to comment on, especially given that it would be a regular 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 if there's nothing to have those kinds of discussions will come up, but rather not comment on any regulatory strategy.
Joe Catanzaro: Okay. So fair enough. I just want to follow up on feldspar question and TROPiCS. I know you guys are driving to potential accelerated filing in 2021. And as you just noted that data potentially the first half of next year, have you guys already enrolled the number of patients required for that interim ORR to occur and just again, understanding that there's some durability and follow up required for that interim to occur?
Brendan Delaney: Without going to blow by blow, I think giving them we're giving the general guidance that we feel comfortable when we're going to report out and just file it. I think you can assume if we haven't reached, you were very close that might've reached it as well. I really don't want to get into where we are exactly.
Joe Catanzaro: Okay. That's helpful.
Brendan Delaney: I've seen your modeling skills more.
Joe Catanzaro: What was the gross to net in the quarter and any guidance around that moving forward? Thanks.
Usama Malik: Joe, this is Usama. Listen, I'm sure you'll read the Q and see the footnote there, but our guidance remains in the 15% to 20% range, it's early days. These are our best assumptions based on comparables, and as we get that better data, the growth in that we'll continue to refine overtime.
Joe Catanzaro: Okay. Got it. Thanks so much for taking my questions and congrats again on quarter.
Brendan Delaney: Thank you, Joe.
Operator: Thank you. Our next question comes from Tazeen Ahmad with Bank of America. Your line is open.
Tazeen Ahmad: Thank you for taking my questions. Maybe one on non-small cell lung cancer. Based on where you are today, when can we expect to see some data from this study? And can you also just give us your thoughts about, it's hard to see apple-to-apple comparison, but how would you think about the profile of your drugs versus the Daiichi drug for example both in terms of efficacy and safety. And then also, I'd just like your thoughts about the deal that was announced, expanding the relationship that you have that to include this particular Trop-2?
Brendan Delaney: Sure. On timing of data Tazeen, that study is the one that we've most recently turned back on as following the shutdown of all our enrollments due to COVID. And so, that are likely to be certainly a 2021 events in terms of the data from that study. In terms of this comparison on the efficacy side, if you follow the trajectory of this 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. We saw substantially higher response rates and I think finally landed in the high teens 19% or so per 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 been saying is important as you think about earlier lines in combination setting is a safety profile and there it is clear differentiation where we've, I think only had one case of ILD in the 500 or so basket study Phase 1 and the data in ASCENT will come out soon. It has one, you can judge the safety profile, but there was nothing that whatsoever suggest we have an ILD signal or any major side effects that that would be irreversible and/or potentially trying to be life threatening. I can say most recent data said they disclosed to Grade 5 ILD and across 4 6 per case. 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 the combination setting. With respect to the collaboration with AstraZeneca, I can't really comment on that. I think you saw the deal terms. You saw the stages of development, and I think we just feel generally very pleased with where we are in terms of first approval all along with ASCENT and multiple indications registrational to come. Yes, I'll just leave it there.
Tazeen Ahmad: Okay. And what are your thoughts on additional collaborations you obviously look to be pretty fruitful among others. Are you of the view that, the more or do you think you have an collaboration now?
Brendan Delaney: So, I think we've sort of covered by in large, the key basis with respect to the setting. So, earlier line all the way up to frontline, even in some instances, neoadjuvant or adjuvant setting, and then also covered many of the bases of respectable checkpoint combinations and parts that PD-1 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 sequel 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 service to us, terms in all our collaboration's are very favorable to us. I mean, the medics, it really only improves our, our ability to touch more patients and identify more opportunities and if such opportunities were presented themselves would 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 of for the registrational studies. Those are obviously costly and would not be what I would call sort of collaborations or loose collaborations that way we didn't entertain them now. And how we go about funding those and collaborating with those, except the different topics.
Tazeen Ahmad: Okay and then maybe one finance question or financially related question. What you ultimately expect the payer mix to be for negative between government and commercial?
Brendan Delaney: This is Brendan. Our commits still are the same55% commercial, 30% to 35% Medicare. The mix is a little different than other tumor sites because of the relatively young age of the population in triple negative breast cancer.
Operator: Our next question comes from Michael Schmidt of Guggenheim. Your line is open.
Michael Schmidt: Hey guys, congrats on the Trodelvy launch and thanks for taking my questions. I had a couple of maybe first on the launch itself. I was wondering if there was some kind of a pent up demand or a patient bolus. And in the second quarter, I'm just thinking about some of the trajectory over the remainder of a year. If there is, some more steady patient flow going forward, if there was some type of photos up front that helped in the second quarter.
Brendan Delaney: It's hard to tell. Michael, this is Brendan, hard to tell. I think people generally assume that there's a bullet, however, in triple negative, I think there's a because of how devastating the disease is and how rapidly patients progress. I'm not sure I think there were patients waiting, but I'm not sure. We didn't build up a tremendous bolus. As you describe, 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 generally, but it doesn't necessarily look like you're seeing a traditional bolus type of launch curve.
Dr. Behzad Aghazadeh: Have 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 total lockdown, including the city, I guess, now we you're -- in cities like New York, the major cancer centers were, did not come alive until much later into the quarter, because of the COVID pandemic, so I think have an certainly was more than offset by that dynamic.
Michael Schmidt: All right. That makes sense. Thanks and then a couple in the pipeline, maybe first on your cancers with the data coming up here soon and I guess in third line patients just wondering how you see the drug position relative to Celgene part in the initial indication. I'm not sure if you've done any market research in terms of its potential use relative to that?
Brendan Delaney: Yes. I can comment first, Michael. We've done a lot of work with GU docs who treat bladder cancer, obviously -- is a good product and 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 used first doesn't preclude the other product from being used second. So, 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.
Michael Schmidt: Okay.
Dr. Loretta Itri: 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 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 Brendan also alluded to these products don't appeared to have cross assistance. We have had patients in our studies that have received pembrolizumab 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. Pembrolizumab has just a different set of 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 looks like we're going stay in neutropenia and diarrhea. So, it's just population, and so if you're managing patients, if someone comes in with a platinum-based neuropathy to star or is diabetic and has diabetic neuropathy you're going to kick a drug that is more suitable for that patient from a 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 benefits for patients because of the amount of lapping 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: Yes. And then just a question on the bigger picture development and neuron cancers, I know you have a couple of studies ongoing or plan now in combination with PD-1 inhibitors, with Roche and then with Keytruda, and both of those are post-platinum in the second line setting. I was just wondering, number one, if those studies are especially the cohort 3 combination, if that is something that could potentially be turned into a registration study? And how you think about the opportunity maybe in first line or even the setting on the term?
Dr. Loretta Itri: It's so very early for us to be making any kind of regulatory plans around it. But I mean, I believe ultimately Trodelvy belongs farther up front, I think after talking with the leadership of the community, that is the general feeling and when it goes up for us, it's probably going to go in combination. So I think time will tell, but there's certainly nothing about, Trodelvy in terms of this toxicity profile that prevents it from being brought up front or being used in combination.
Michael Schmidt: Okay. And then 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 tolerating of the Trodelvy study including the interim analysis. And I was just wondering if you could provide any additional comments on, your thinking at the time as to how to control in an absence, large data, especially around response rate PFS?
Brendan Delaney: The control arm we generally thought it would be a high single digit, low double digit, and in terms of response rate, and you'll get to see for yourself what that number looks like. But I think the PFS already tells you that number you're know for the control arm of ASCENT, that literature might've overstated what to expect in a randomized setting, this very late line patient population. Now, what's also remarkable again, on data that now we disclose, how similar Trodelvy performed in a sense versus our Phase 1 study. And I think generally our collective view would have imagined you'd share that opinion that basically study genuinely deteriorates versus a Phase 1, few sites studies, but Trodelvy has recapitulated in triple negative breast cancer, the data from the Phase 1 and on the first 35 patients, and you see the oral cancer, it also recapitulated post checkpoints what we previously reported in a 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 15% of the sponsor in chemo, there's really no evidence to support that once the patient has experienced for monotherapy than CDK4/6 and two other chemo, the question to the clinician is we'll watch less. And if they say, well, we would use a rebel and well sure, but here's a patient that just saw a ruble triple-negative different disease a little bit slower progressing generally thought that after so many lines of therapy, once they're confronted with that sort of thinking their view is that, -- probably won't be that different to ASCENT, at least not the performance of the chemo. 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 probably adjustments. But I think, from a trial study design standpoint, from a powering standpoint, I think we feel pretty good about.
Michael Schmidt: Okay, great. Thanks for all this detailed answers. I really appreciate it.
Brendan Delaney: Sure. Thanks.
Operator: Thank you. Our next question comes from Jim Birchenough from Wells Fargo Securities. Your line is open.
Nick Abbott: Good afternoon. It's Nick on Jim and congratulations on the splendid launch in long time coming. My question is, what point do you think the Phase 3 ASCENT result is to the overall message on Trodelvy? I guess another way, are there a group of physicians out there who would be slow to adopt this without posting Phase 3 confirmatory trial? And if that's the case here, you considering a Phase 3 confirmatory trial in a late-line urothelial cancer?
Brendan Delaney: Hi. This is Brendan. Yes. So, I think the ASCENT data will be very meaningful within the market. The reason I say that is for people who are slow, I mean, physicians who are slow to adopt, there is a perception of a survival advantage with Alvin in the third line setting based on I believe a retrospective analysis. So, certainly coming with a Phase 3 perspective trial reporting the data that we have, then subsequently updating the prescribing information will have a strong impact in the market. So, long way to answer your question, but yes, certainly, will have I think a large impact on the market.
Dr. Behzad Aghazadeh: Nick, I'll add to that though. I think triple negative, per say, I personally am not so convinced that it's going to have a pay and night effect. Thanks Brendan. I always go back and forth on it. But I always say, what else would a physician prescribed in that indication, we all said for many years with no prior treatment option. But I think it is important in when you sequence it versus other agents that's generally being considered to have a survival benefit. So having the survival benefit, I think is additive here and so takes away one reason why someone may not want to prescribe Trodelvy ahead of why seeing or how you seen previously for -- setting. But I think it is far more important here is, it's going to make it very hard for anyone else to answer this thing, number one. Because you have a survival advantage and that is still the gold bar. This model matches meaningful, clinically meaningful. But importantly also in Europe and other jurisdictions, survival is a very important end points from a pricing standpoint and while the U.S. is generous in that regard from reversal standpoint. In Europe, this is a better meaningful development for the Company.
Nick Abbott: Thank you. And so, just on your urothelial cancer, do you need to follow the same playbook?
Dr. Behzad Aghazadeh: I think a rather comment. But my opinion is that once you have clear differentiation and there'll be other studies that are read out before comparative study or Phase 3 randomized study to read out, we have probably focus on read out and if it. I mean, I think at some point the incremental data, while its still important probably not going to be as surprising or impactful because people will obviously become very aware of data that we generated from a sense and hopefully from other studies that we rejoined in, but specifically you would feel having an overall survival end point, Loretta.
Dr. Loretta Itri: 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 rates of progression free survival, duration of response, valuable pieces of information, and people were prescribed on the basis of that. Additionally with the safety profile of our drugs, given the limited available treatments that we have for these advanced patients, I don't think any of them going to hold fast then using Trodelvy in the appropriate setting.
Nick Abbott: Thank you. And then, you provide us some comments on product supply and also the timing of the switch to Samsung?
Dr. Behzad Aghazadeh: I won’t really comment in any more detail from what we said previously, but we are working and continue to work to bring Samsung on the line 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 come alive. And, looking promising, as I said, as long as it comes online in any timeframe that we needed to, we will be very well off.
Operator: Our next question comes from Chris Howerton of Jefferies. Your line is open.
Chris Howerton: Congratulations on the long time incoming launch, so great to see. I guess, for Brendan, maybe just a couple of questions for you, and then I suppose the question Behzad. With respect to the launch, do you have any sense, I understand that it's early but what kind of reordering you've seen from the institutions that have already ordered? I think you said 500. Go ahead.
Brendan Delaney: The reorder pattern is very high.
Chris Howerton: Excellent and then the other I just found intriguing was that in this virtual environment typically medical education tends to occur associated with conferences. Just curious if you could describe someone of that strategy to access the medical professionals in the more virtual environment and any learning that you've had along the way.
Brendan Delaney: Listen, it's mostly been positive and 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, a program wide program that you may have 10 people. You may have one on one there. So it 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 you'll put things but more national broadcast with key opinion leaders in breast cancer who have experience with the drugs. 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 a group of physicians in Florida almost real time, right? And it can be set up very quick. 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: Okay. Alright. Fantastic. And for Behzad, clearly we understand, I understand that the focus is Trodelvy at the moment, but in terms of the some of the commentary on use of proceeds to fund 130 and 140 some as a pipeline down the line. So just curious when and if we might expect any updates from those earlier stage programs.
Dr. Behzad Aghazadeh: Yes, 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 manufacturing ADC conjugation, et cetera, and then putting it into patients, it certainly is not something that is going to be a very near-term events. But you have to plant those seeds, and when the right time comes we pick the fruit.
Chris Howerton: Understood. Okay. And then maybe a quick through some just perhaps what we can expect in terms of additional milestones from your collaboration with Everest, and maybe some sense around some timelines in terms of when we might expect some updates from that side?
Usama Malik: Sure. As I just talked this previous quarter, we did receive a $60 million milestone payment on FDA approval from Everest. If you recall the total milestones around development and sales total to around $710 million. Those are based on launches of the various trials participation in global trials for patient in our regulatory approval in different countries. And those details were when we read that contract. And there's a number of milestone payments associated with sales and sales milestones as the product that's commercialized in various markets. And then last but not least there royalty milestones, ranging anywhere between 14% and 20%, depending on various expedition 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 disclose on this call, but I think that give you a good indication.
Chris Howerton: Sure. Okay. Well, thanks so much, and again, heartfelt congratulations and very glad to see your progress.
Brendan Delaney: Thank you very much.
Operator: Thank you. And our next question comes from Paul Choi of Goldman Sachs. Your line is open.
Paul Choi: 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 longer to get through P&G and so forth, but just sort of where you are in terms of targeting and how many of your target centers have the adopter or utilize the drug? Thank you.
Dr. Loretta Itri: 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 validated assay with which to assess two levels. I think that, we are in the process of analyzing those data now, from the sense, 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 expression. We don't know how it evolves over the lifetime of the tumor. We don't know if patients start out with high trope levels and stay that way. So there are many, many more questions about a Trop-2 to target than there are answers. And I think it's going to take us some time to even figure out any advanced setting, exactly what the message is. So that's all I can say about Trop-2 right now.
Paul Choi: And then anything else on others solid tumor types?
Dr. Loretta Itri: I think they're all in the same boat, frankly. For us, 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 correlation.
Brendan Delaney: 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 the community oncology setting, and usually we expect the academics to come on because they have the clinical trial experience, but we seem robust across the academic and community. What interesting on the academic side is, COVID that had an impact there on the ability for different institutions on the academic side to even meet and have a formulary review on a P&T meeting and that type of things. 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 over here from feedback from the physicians in that the academic world, they're very impressed with the profile of the drug. So slight bumps in that area with COVID, but I think we've managed to work through them so far.
Operator: Thank you. At this time, I would like to hand the conference back over to Chau Cheng for closing remarks.
Chau Cheng: On behalf of the entire leadership team, I'd like to thank you very for joining us this afternoon. We look forward to updating you in the future on our ongoing progress
Operator: Ladies and gentlemen, this concludes the conference. You may now disconnect. Thank you everyone and everyone have a wonderful day.