Q2 2020 Immunomedics Inc Earnings Call
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Ladies and gentlemen, please standby your conference will begin momentarily. Thank you for your patience and please standby.
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Good afternoon, ladies and gentlemen, thank you for standing by as a reminder, this conference call. This being recorded today is Wednesday August.
Yes, 2020 at this time I'd like to turn the conference over to child Chang Senior director of Investor Relations of human.
Immunomedics, Sir please begin.
Thank you at all.
Good afternoon, everyone welcome to Immunomedics second quarter 2021 to the school. Please note that we have supporting slides to accompany today's call.
You can access those like Oh not website.
Page.
With us on the board today, a deposit base I got the date executive Chairman.
I will give a quick overview of the quarter rented Delaney chief commercial officer, who will provide early commercial uptick commentary and metric.
MPG, Chief Medical Officer, who will walk us through clinical development priority and what's coming up the.
Some of money Chief Financial Officer, and Chief Business Officer, who will provide you with an overview of our financial was this past quarter before opening the call well question.
[laughter].
Before we begin I'd like to remind everyone Thats doing this call me movie, making forward looking statements made pursuant to the private securities.
It can be bone act of 1995, such statements made in Boston Nipigon and uncertainty therefore actual results could differ materially from those expressed or implied won't be cool.
Does that make both such a difference include the uncertainties associated with pharmaceutical development and the regulatory approval process. That's why we had difficulty in forecasting sales revenues and expenses.
Mention about the risks and uncertainties faced by Immunomedic is contained under the caption respected and put it into the company.
Robbie reports filed with the Securities and Exchange Commission, including the company's annual report on form 10-K for the year ended December 31st Wednesday Night.
With that let me turn to coal but to be dock.
Thank you Chad 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 were able to launch fidelity in the U.S. within one week of Ft A's accelerated approval.
Currently we delivered on our promise to report topline results from the confirmatory phase three assent study in mid 2020.
The results clearly demonstrated significant benefits for Dolby is bringing to patients with metastatic triple negative breast cancer.
Financially, we successfully bolstered our balance sheet with a very well received offering and a well positioned to fund our toward growth trajectory.
And finally as the World continues to contend with the challenges presented by the Cobot 19 pandemic I'm just.
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 it's clear that today will be has been well received by patients under treating physicians alike.
In only two short months since approval, we achieved $20.1 million in net sales I.
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 to Dalbey, it's 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 stay on this topic in a few moments.
So there will be the excellent risk benefit profile has recently been corroborated by the confirmatory phase three assent study in a study that involve more than 500 patients treatment with fidelity resulted in a 59% reduction in the risk of cancer progression compared to a single agent chemotherapy.
More importantly, fidelity also met the key secondary endpoints of this study, including overall survival an objective response rate.
With these results today will be becomes the first antibody drug conjugate or 80 C to improve the clinical outcomes in people with relapse or refractory metastatic triple negative breast cancer would receive two prior therapies.
More broadly we're proud to be the first company to bring an empty trope to AIDC to patients and successfully validated trip to as a target for cancer treatment in the process.
So there will be has a unique and differentiated safety and efficacy profile that is is that as distinct from other ADCC 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 to deleverage development activities into earlier lines and combination setting.
Nobody 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.
The first Brendan will now discuss in greater detail our launch on a commercial progress today [noise].
Thank you base.
It is an exciting time at immunomedics and I'm thrilled to have the opportunity to update you today on the exceptional launch of trove delvina in triple negative breast cancer.
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 and by our entire organization now the time as Tom. The finally share out all of that work has culminated into a very strong product launch where the reason.
It's 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 launch has been driven by three strategic imperatives first we need to quickly established codell the 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 schroedahl the 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 throw Dolby prescribers. These early adopters, having 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.
No im going to 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 oncologist had been anxiously awaiting trial. These approval. So I applaud my immunomedics colleagues for finding every way possible to shave days hours and even minutes off the drug availability timeline.
Despite the headwinds that launching within a coated 19 pandemic can.
Have presented.
Launched seems never wavered and never lost focus.
Their execution started with Codell, the dot 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.
Launch to date over 1000 healthcare providers in the United States have attended a tour Deli education events.
Through the ongoing education efforts. Many of these healthcare providers are being exposed to the clinical profile showed lv 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 for Dolby clinical profile has been positive and many oncologist express a comfort with managing patients on therapy.
Although early market share estimate can be unreliable recent market research conducted with community oncologists in the U.S. revealed that intent to prescribed totality 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.
Im 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 which odell. These within the academic breast cancer centers of excellence.
Evidenced by the rapid update of NCCN guidelines to reflect the TRO del the FDA approval.
However, we have also been pleasantly surprised by the robust uptake of pro Delvina 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 we're over 500 accounts that have ordered Philadelphia.
Recognition of both the unmet need in triple negative breast cancer and the strong throw Dolby clinical profile has also been reflected in the sense of urgency with which payers have been adopting formal coverage policies for the products.
Having formal coverage policies in place with large payers removes barriers for treating physician and paves the way for broad patient access.
Thank you review and 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 totality. During the first two months of launch we see that it is exceeding the performance of both breast cancer and broader oncology benchmark.
I am happy to report that wants to date that trend has continued with payers covering 70% of lies in the U.S. market reviewing and adopting a toward LD 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 P eight to pie position without major restrictions.
All this rapid payer progress combined with a strong suite of patient support resources available through trudell. The access services has resulted in strong patient access to throw delving since at FDA approval.
In summary, we are excited about the rapid uptake of Codell decent FDA approval and are happy that triple negative breast cancer patients now have access to the first trucks to 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'd like to extend another sincere. Thanks to all my immunomedics colleagues for making this early launch a tremendous success.
Now Loretta, we'll give you an update on our clinical program.
Thanks Brandon.
The next months are going to be very busy and very exciting drastically in two important studies to report and file for regulatory approval.
First and foremost is a confirmatory phase three cents study in metastatic triple negative breast cancer last month, we announced that this study met its primary endpoint of progression free survival 468, brain metastasis negative MTN DC patients with a hazard.
Ratio 0.41, and a P value less than 0.0001.
Together, we also met key secondary endpoints, including overall survival and objective response rate.
Importantly, the safety profile after daily 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 and the 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 Twentytwenty that seat full approval of Tri County.
We also anticipate Europeanist admission of these data in the first half of 2021.
Another dataset that we hope to presented at ESMO Invitro Cu Oh, one study in metastatic Urothelial cancer, you may recall that at last year's ethanol. We recorded an interim objective response rate of 29% in 35 patients who had failed prior platinum.
Based therapy as well to 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 at ESMO Congress.
As a reminder, earlier this year at FDA granted to Downey fast track designation for the syndication.
That designation along with data from Trophy you all one can potentially form the basis of a biologics license application for accelerated approval of traditionally in metastatic urothelial cancer subject to review by the FDA.
Additionally, enrollments have come down for cohort three that is studying the combination accidentally anvil listen map.
These cohort three patients are checkpoint inhibitor naive and as sales of platinum containing regimen in metastatic setting.
Following with stoppage of enrollment is it comes in 19, we have recently resumed enrollment and I am pleased with the early pace of accrual.
We are additionally, pleased to announce that clinical sites to the Registrational phase three tropics owed to study ups for delving in hormones response and hormone receptor positive hertwo negative metastatic breast cancer have resumed patient enrollment, while we're very pleased by the pace of accrued.
Which is almost back to pre code that level.
Given that some regions are still facing our resurgence in new co that 19 cases.
We look to this period ahead to gauge whether there's any impact on trial sites before we commit to timeline 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 a submission for accelerated approval. In 2021. This interim look was agreed with FDA prior to stay.
The initiation.
We're also pleased that the open label Phase two trial phase three study after Downey in metastatic non small cell lung cancer has very recently also roots in patient enrollment at select site. This study will be expanded to include patients with claimants carcinoma of the head and neck later this.
Here.
I'd like now to give an update on selected collaborative studies.
How 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 at either glioblastoma or brain tumors metastatic breast cancer to evaluate the bio availability totality in the brain.
In this study in addition to evaluating efficacy and safety. The team is measuring the levels of Sn 38, and its metabolite in the tumor biopsy samples to enable a comparison to this year I'm concentration ratio will demonstrate the amounts externality 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 two neo stars steady if accounting in patients with localized triple negative breast cancer in the Neoadjuvant setting has dose first patients.
As announced last month, we have expanded our ongoing collaboration with Roche to evaluate for daily plus.
She is listen map to include metastatic urothelial cancer in metastatic non small cell lung cancer. In addition to metastatic triple negative breast cancer.
Also adopted Delaney as Dana Farber has launched two studies, combining two definitely with Pembro listen man in PDL, one negative metastatic triple negative breast cancer and in PDL, one positive hormone hormone responses hertwo negative metastatic breast cancer.
Finally in China, our corporate partner Everest Medicine has launched a new single arm Multicenter phase Twob study at Fidelity in third line locally advanced or metastatic triple negative breast cancer.
Like Brendan I'd also like to thank my regulatory and clinical teams for their dedication in ensuring that our timelines in gold for four cents for Matt.
And as well as for the continued push in coming months. There is no rent for the weary it seems.
I'll now turn the call over to summer for financial update.
Thank you Loretta for the second quarter ended June Thirtyth 2020, Immunomedics reported net product revenue for Dolby of 20.1 million compared to no product revenue for the comparable quarter ended June Thirtyth 2019.
The FDA granted accelerated approval for today will be on April 22nd 2020.
Cost of goods sold was 1.7 million for the quarter ended June Thirtyth 2020, there was no cost of goods sold for the comparable quarter ended June 30 29.
R&D expenses decreased by approximately 10 million to $42.6 million for the second quarter ended June Thirtyth 2020, compared to the comparable quarter ended June Thirtyth 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 of course.
One of such costs are capitalize on the current period.
Approval so Doug.
The decrease was partially offset by an increase in labor costs as well as clinical development and operational costs from expansion of clinical trials with increased enrollment.
As DNA expenses increased by 14.6 million to 28.9 million for the quarter ended June 32020, compared to the comparable quarter ended June 32019, primarily due to increased labor cost from incentive and stock based compensation recognized upon FDA approval of two adobe the United States as well as.
Increase in marketing and promotions costs in connection with the commercial launch of fidelity.
Net loss attributable to stockholders was 66.5 million or 30 cents per share for the quarter ended June 30, 2020, compared to 76 million or 40 cents per share for the comparable quarter ended June 30 2019.
As of June Thirtyth 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 $60 million milestone payment from ever medicines for today.
The approval the United States.
We believe our projected financial resources are adequate to some are adequate to support our commercial launch of two delving in the United States and metastatic triple negative breast cancer continue to expand our clinical development programs torture delving invest in the broader clinical development of the Hdc platform continue to scale up manufacturing and manufacturing.
Process improvement and general working capital requirements.
This summarizes our second quarter 2020 financial results and now concluding remarks from beta.
Thank you saw loved brands and then Loretta.
Given up took two is widely expressed in a number of solid cancers. We have a robust clinical development program for two belviq aimed at establishing it as a standard of care in triple negative breast cancer and broadening its potential use in other cancer types advancing into earlier lines, either as a monotherapy or in combination with other agents.
We were excited to submit the some supplemental being able to elevate them CNBC for full approval in the coming month, and we look forward to present in the comprehensive study results for instance, and final study results, which will fuel one hopefully at ESMO in a few short weeks further we're highly encouraged by the data in MTN BC and the potential implications for the topics so too so.
For the control our mirrors the assent study exactly.
And with that operator, please open up the call for questions.
Thank you. Thank you.
As a reminder of asking the question your need to press star one on your telephone.
Withdraw your question. Please press the pound cake. Please stand by what we called out the culinary roster.
Our first question comes from.
Peter Lawson with Barclays. Your line is open.
Hi, Thanks for taking my questions just maybe a question initially.
Brendan all levels the level of potential off label use certain levels of.
Inventory stocking orders.
Yes, Peter how are you.
As you would expect were promoting the drug within the labeled indication and.
Don't really had too much visibility into what's going on in the off label and wont comment on it.
And then maybe just on the level of inventory or stocking orders you think you got in the quarter.
You know with the type of drug in the type of distribution I think were in line with what you'd expect.
For relatively low levels of.
Inventory.
Okay. Thank you and then maybe any any details around any.
Reimbursement pushed back are you seeing or bolt.
Great.
Yes.
Peter as I said in the in the comments, we've had very little pushback and it's really been encouraging because I think on the payer side you use you see the as well as 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 than the benchmarks, which is I think speaks to the unmet need and speaks to the impressive results that we've put forward and 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 PPA the pie.
Situation and for most of them for any restrictions that have put in place there very minor for example, prior taxane or something like that and Thats.
You know kind of standard of care anyway on the treatment algorithm within triple negative so.
Very very well accepted by the payer audience as well so far right. Thank you are just a final question. The initial patients that they differ in any way from the clinical trials setting.
Pardon for us to tell we read the patient level data, we don't necessarily have right now so really hard to comment on that.
Great. Thanks question Congrats on the first quarter. Okay. Thank you very much view. Thank you.
Our next question comes from Phil Nadeau with Cowen Your line is open.
Good afternoon, congratulations on the progress and thanks for taking my questions.
Just a couple on the pipeline you mentioned the trophy euro on kind of data that's going to be coming at ESMO.
Based on me from issue or have are there any.
Major differences in the patient characteristics between 35 patients in the interim versus the 113 full dataset anything there could be.
Biased results, one way or the owner.
No the to the two sets of data appear very very similar in terms of patient characteristics and certainly anything that we can see as differentiate them.
Great. That's helpful and then second on the tropics, who too.
Is there any update on when you would anticipate the interim analysis.
And maybe maybe diving into an instrument a bit more detail have you ever disclose the number of patients.
To be included in the near term in that in the powering for core or that is built into the study design out the interim.
We haven't disclosed that Phil either because of your revenue both disclose the number of patients I think it was 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 plus months.
As the duration of response assessment.
And that all together I think it's it's.
Too early to tell definitively, but we did provide clarity today that it.
Data warrants that it would be the basis for the next fiscal filing in 2021. So if you work backwards from that I think we'll be certainly have reported data.
I'm in the first half of next year, and if we could move with any sooner we certainly do that.
Not perfect to know exactly when that will occur, but we're zeroing in on knowing when that can occur.
Perfect. That's helpful. Thanks, again for taking my questions.
Thanks. So thank you next question comes from Joe Kentaro with Piper Sandler Your line is open.
Hey, guys. Thanks, so much for taking my questions and congrats on a strong start here maybe first in recognizing that we've only seen topline ascent data just wondering if you've seen any impact then in terms of prescribing patterns and usage since the topline read out and in early July and and wondering if there's any.
The with what the filing around those data to have a discussion with the FDA around changing into like let met language in the label around prior treatments, but again understanding that it sent the same population that the accelerated approval.
Yes. So Joe this is Brendan I'll 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.
Try to parse out I 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 have been impressed overall with the the.
The growth in the trajectory and it's hard to parse out what that what's driving that as you know whether it's the announcement or or just general excitement for what is a very impressive drug.
Okay. Thanks, any any thoughts around opportunity for maybe having a discussion around the the language in the label indication what the sent the again understanding that there is.
Some early on usage potentially one going beyond the available therapies in the second line setting just any thoughts there.
Yeah, so little hard to comment on especially given that it would be a regular dialogue with sort of wouldnt comment on anything ahead of the discussion, but let us get this data to the FDA make sure we get their label fully updated than if theres enough to have those kind of discussion of through come up but so.
Rather not comment on any regulatory strategy.
Okay fair enough.
I want to follow up also unfolds part question and tropics, though too I know you guys are guiding to potential accelerated filing in 2021. Then is that you just noted that that data potentially the first half of next year.
Have you guys already enrolled the number of patients required for that interim or to occur and just again understanding that there's some.
Durability and follow up required for that in term to occur.
So without going to blow by blow I think given that we're giving that general guidance that we feel comfortable when we're going to report Avenue to file as I think you can assume if we haven't reached we're very close but we might have reached as well I really don't want to get into where we are exactly.
On enrollment.
Okay. That's helpful. Leslie I continue that modeling skills I'm worried [laughter].
What was gross to net in the quarter and any guidance around that moving forward. Thanks.
Sure Hey, Joe This is Tom I.
Listen I'm sure you read the Q and and see the footnote there, but our guidance remains in the 15% to 20% range. It's early days. These are best assumptions based on industry comparable sales and as we got that better data. The gross to net will continue to get refined over time.
Okay got it thanks, so much for taking my questions and congrats again on the quarter here.
Thank you Joe.
Our next question comes from to same I met with Bank of America. Your line is open.
Thanks, so much for taking my questions, maybe want to non small cell lung cancer I'm thinking where are you work today bad word 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 do an 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 her thoughts about the deal that was announced expanding the relationship that extra has.
That to include that this particular trip to.
Or.
On timing of data because in that study is the one that we've most recently turned back on as a following the shutdown of all our enrollments for.
Due to cope with and so that's unlikely to be it's 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 Tensixty two efficacy from ASCO two world long in the NASSCO updates.
Most recently I think you'll see a very similar trajectory is what our results were where they we started this is actually higher response rates and I think the finally landed in the high teens, 19% for so for the publication I think there in the low 20%. So it looks pretty comparable we haven't seen a follow up for them to get any sense of duration. The only other key to friends.
Asia, which we've always maintained as important as you think about earlier lines in combination setting is a safety profile in there there's clear differentiation where weve.
I think only had one case of the Io d. in the 500 or so basket study.
Phase one and the data in a sense, we'll come out soon it as one you can judge the safety profile, but there was nothing whatsoever suggests we have I LDC signal or up or any major side effects that that would be irreversible.
And or potentially frankly life threatening it I think they've most recent data. So they just go to wait five oil deed.
And across doses of four six in a big strategic 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 personal superior.
Safety when it comes single agent, but we'll certainly in the combination setting.
With respect to the.
Collaboration without specific I can't really call is on that I mean, I think you saw the deal terms, we saw the stages developments and.
I think we just feel generally very pleased with where we are in terms of first approval along with a sense in multiple indications registrational to come.
Yeah, I'll just leave it there.
Okay, and what are your thoughts on additional cooperations, you've obviously got.
Well look to be pretty for one quick question, Mark among others or you have to do that and all the more the merrier or do you think you have enough cooperation snow.
So I think we've sort of covered by and large the key bases with respect to the settings. So earlier line, although after frontline even in some instances neoadjuvant setting and then also covered many of the bases with respect to both checkpoint combinations in parts and PD one PDL one.
Well as an PDL, one positive and Peter one 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 hundred pharma partner were to step forward and provides an attractive terms to assert our terms in all our collaboration is a very favorable to us immunomedics. It really only improves our ability to touch more patients and identify more opportunities and if such options were presented themselves, which certainly entertain them, but as far as.
Our main objective, but always been to identify it will be areas, we need to assess and then.
Ultimately figure out which will be worthy of for the Registrational studies. Those are obviously costlier and would not be what I would call sort of collaborations or lose collaborations the way we've in infotainment until now and how we go about funding those and collaborating with those if that's a different coffee.
Okay, and then maybe one financed question or financially related question, what do you ultimately expect the.
Payer mix could be for for triple negative between government and commercial.
Yes. This is brendan touching our estimates still are the same.
55% commercial 30% to 35% Medicare the mix is a little different than other tumor types because of the relatively young age of the the population in triple negative breast cancer. So.
Okay. Thank you.
Thank you.
Next question comes from Michael Smith of Guggenheim. Your line is open.
Hey, guys congrats on the.
The 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 and the second quarter I'm just thinking about some of the trajectory over the remainder of the year. If there is.
You know some more steady patient flow.
Going forward if that was some type of photos upfront that helped in the second quarter.
Hi, I'm, it's hard to tell Michael it's Brendan hard to tell I think people generally assume that there is a bolus. However in triple negative I think there is because of how devastating diseases and how rapidly patients progress I'm not sure.
I think there where patients waiting, but I'm not sure.
Built up to to be a tremendous bolus.
As you described also based on its 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 that doesn't necessarily look like you are seeing a traditional bolus type of.
Launch curve, a Mike 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 of ancillary total lockdown, including the city Pfizer than I guess now I know you're both mid realism.
Cities like New York, Some major cancer centers were did not come alive until much later into the quarter because of the coal with Fedex. So I think if there had been a bolus. It certainly was more than offset by but with that dynamics.
Alright that makes sense. Thanks, and then couple on the pipeline maybe first on Urothelial cancers with the with that data coming up here soon and that's in third line patients. Just wondering how you see the drop positioned relative to C.M. snakes pad SAP and the initial indication.
Not sure if you've done any market research in terms of its potential use relative to two that.
This is Brendan yeah, I can I can comment first Michael a we've done a lot of work with the do you docs, who treat bladder cancer, obviously pads of is it a good product there were happy to patients have such a.
A strong treatment option in the space first of all their out to a lead moving up in the earlier lines of therapy.
Therapy, which I think is advantageous for us because that means theres room for us to grow earlier I do think our profile is differentiated certainly.
We expect strong efficacy, but we also expect expect with error.
The profile and specifically, what we don't have peripheral neuropathy and and some of the other deferred at different limiting side effects I think we will.
I have a place to play strong place to play in 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 patients.
Characteristics and what they're presenting with one option may be better than the other first but certainly whatever use first doesn't preclude the other product from being used second so on I think were pretty very excited about our differentiation within the space in our competitive position, but as I said I think it's all positive.
For patients to have multiple options across multiple lines of therapy.
Yes, okay.
The climate slated for rid of what.
Over the coming with clinical clinically there as as Brendan.
Already said and 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 said we have two major new products available for the treatment of this population that is greatly in and in Britain and it's also alluded to.
You are these these products don't.
Appear to have crossed assistance.
We have had patients in our studies that have.
Received enfortumab and have done well on it and then going on to progress and then have done well on Sacituzumab. So I think that Theres 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 has.
Very different side effect profile in 40, Mab has a just a different set.
More I LD that is something of a concern.
On and neuropathy, which is something of a concern, whereas we are primarily new stripping and diarrhea, and we have always been nicotine in diarrhea, and looks like we're finishing extend the entire area. So you know.
It is.
And it's just a different population and so if you're managing patients if someone comes in with a flattening based neuropathy to star Wars is diabetic and has diabetic neuropathy or neuropathy, you're going to pick a drug that is more suitable for that patients from the side effect profile.
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 non overlapping toxicity. We are even examining in some studies the possibilities putting the two drugs together, but it's way too early to talk about.
What that might look like.
Yeah.
And then just a question on the bigger picture development.
Field cancers, I know you have a couple of studies ongoing or planned now in combination with PD one inhibitors.
Erosion and then what's the Keytruda and both of those are into the post platinum in a second line setting I was just wondering you know number one if.
The dose studies are especially big cohort three keytruda combination if that is something that could potentially be turned into a registration thinking on registration study and how you think about the opportunity maybe it's far slant or even the actuant setting it on the term.
Its so very early for us to be on making yeah.
Making any kind of regulatory plans around it.
But yes, I mean, I believe ultimately travails the belong farther upfront I think after talking with the leadership as the community that is the general feeling and when it goes up front, it's probably going to go in combination and so I think time will tell but there are certain.
Really nothing about I'm trying to healthy in terms of its toxicity profile that prevents it from being brought up front or being used in combination.
Okay and then one last question I have to US my at tropics, two statistics question as well so.
Well I guess my question is really around.
Control arm and I guess the question has.
You didn't have full ascend data, especially on the controlled arm at the time the tolerating.
The Tropic so to 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 I might have performed in an apps and industrial large data, especially around response rate or PFS.
Ill pick that one I think that controlled arm of a sense with generally thought would be high single digit low double digit.
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 youre no for the control arm of a sense that.
I think literature might have overstated.
What to expect in a randomized setting this very late line patient population now.
Well, it's also remarkable on the again on data that now we've disclosed.
How similar trends Lv performs in a sense versus our phase one study and I think generally our collective view would have been.
And do chair that opinion that phase three study general deteriorates versus a phase one few sites study, but two adobe has recapitulated in triple negative breast cancer. The data from the phase one and on the first 35 patients and you'll see little cancer. It also recapitulated post checkpoints, what we previously.
Reported into more mixed patient population.
And now we have a control arm that is identical between this study on topics so too.
Late line patient population that I think also is gonna be so heavily refractory that while we generally fear for markel community to expect high single digit low double digit maybe up to 15% of the sponsoring chemo theres really no evidence to support that once a patient has experienced hormonal therapy that tier four takes into two other chemo.
The question to the clinicians is we'll walk left.
If they say well, we would use the ruble and well sure but here is a patient that just thought ruble in triple negative different disease little bit slower progressing generally thought but after so many lines of therapy. Once they are confronted with that sort of thinking their view is that coolpix, probably won't be that different to ascent at least not the performance of the key more.
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 profitability adjustments, but I think where a patient trial study design standpoint from of hiring standpoint, I think we feel pretty good about took expenses.
Okay, great. Thanks for all that detailed answers really appreciated.
Thank you next question comes from Jim Birchenough.
Securities Your line is open.
Good afternoon to turn a nickel to Jim self funded and.
Congratulations on the splendid launch and a long time coming.
Hi crush it is.
Do you think the phase three sand.
Result is to the overall message on to deleverage I guess another way whether there are a group of physicians out there who would be slow to until this without posted phase three confirmatory trial and if that's the case you considering a pace reconfirmed trial M&A.
Late line Urothelial cancer products.
Are you doing next Brendan.
Yes, so I think the the ascent data will be very meaningful within the market. The reason I say that is for for people who are slow physicians I mean today, who are slow to adopt.
There is a perception of a survival advantage with allovectin in the third line setting based on I believe a retrospective analysis, so certainly coming with a phase three perspective.
Trial.
Reporting the data that we have then subsequently updating the prescribing information, we'll have a strong impact in the market. So long way to add to your question, but yes, certainly were very I think a large impact in the market.
And they all I'll add to that though I think triple negative per se I purposely I'm not so convinced that it's going to have a stay in either thanks, Brendan I would go back and forth on this but I always say what else would a position for slide.
And that indicates that we all set for many years with no viable treatment option, but I think it is important in when you sequences.
Versus other agency as everybody has generally been considered to have a survival benefit so having a survival benefit I think is additive here.
So let's take takes away. The one reason why someone may not want to prescribed fidelity ahead of at least division seeing resolute if it had to say that previously.
Wireline setting.
But I think the far more important.
Component here is.
It's going to make it very hard for anyone else to Ed saves number one because you have a survival advantage and that is still to go Barclays should this amount of matches meaningful clinically meaningful but importantly also in Europe in other jurisdictions survival is a very important endpoints from a pricing standpoint.
And while the U.S. generous in that regard to approval and we'll reimbursement standpoint in Europe. This is a very meaningful development for the company.
Thank you and so just on Urothelial cancer do you need to.
Hello, This thing playbook.
I think.
One other comment, but my opinion is that.
Once you have you clear differentiation and there'll be other studies are going to read out before compared to run study a phase two randomized study of the when you receive it would read out we'd have probably tropics, those who having read out and if it I mean I think at some point the incremental data while it's still important is probably not going to be as surprising or impactful.
So because people will obviously could come very aware of data that we've generated from a says that hopefully from other studies, where we can the insulin, but specifically urothelial, having overall survival endpoint Loretta.
With that.
I I think it's always important to have survival I mean as is the gold standard is clinical trial I don't think it's going to stop anyone from using a drought in that has clear benefit response rate progression free survival at duration of response and wall.
So valuable on pieces of information and people were prescribed on the basis of that.
Additionally, with the safety profile of our drugs.
Given the limited.
Limited available treatments that we have for these advanced patients I don't think anyone's going to hold back from them using using $2000 inappropriate setting.
Thank you and then last from me.
You provide us some comments on product supply bizarre and also.
The timing of the switch to Samsung.
Thank you.
I won't really comment and any more detail from what we've said previously book, we are working and continue to work feverously to bring Samsung online as well.
You have 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 concept to come come alive, and that's looking promising as I've said and as long as it comes online in a timeframe that we needed to.
We will be.
Very well off if you will and.
So far.
Thank you and congratulations on Standalone likes ended luge.
Thanks very much. Thank you. Our next question comes from.
Howard kind of Jefferies. Your line is open.
Hey, Thanks election data also offer my congratulations on a lot of 10 coming launch so great to see.
I guess you know for Brendan maybe just a couple of questions for you and then I suppose a question for based side.
With respect to the launch do you get any sense I understand it's early but what kind of reordering you've seen from the institutions that have already ordered I think you said 500.
Lin Chen daily.
Okay.
I'm sorry, yeah now at the reorder pattern is very high very high Okay excellent. Okay and then the other I just an intriguing was that you know in this virtual environment typically medical education tends to occur associated with coincidences. So just curious if you could describe some order that strategy.
Hosting the medical professionals in the more virtual environment and a learnings that you put along the way.
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 a close.
Co bid.
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.
A program wide program that you may have a 10 people on you may have a one on one or so if you have to do more of them, but but people are engaged I think when you have a strong product like that people want to learn about it so that certainly working our advantage I think we've we've done a lot we changed the marketing mix, Chris like anticipating cultivated and.
Put things like more national broadcast with key opinion leaders in breast cancer, who have experience with the drug. So yes, we just increased the number in those ways, but certainly.
In many of the execution for example, if some of our early speaker programs. Our sales team has done a great job with that but in many ways. We've gotten started earlier because a lead time that you need to plant a life program you just don't need for a virtual programs. So a physician theoretically in New York, who has experienced with the drug can educate.
Group of physicians in Florida, almost real time, right and it could be set up very quick so those those things have been learnings on a positive side.
Obviously working through cobot is not an ideal situation, but certainly some learnings that are here to stay.
Okay, all right fantastic in.
For base overall, clearly we understand there I understand that the focus is onshore Dolby at the moment, but almond trees in terms of some of the commentary on use of proceeds to fund 130 in 140 some of the other pipeline assets for the general lighting. So just curious when and if we might expect any update.
It's from those earlier stage programs.
Yeah sure, let some I think it's going to view the 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 AIDC conjugation et cetera, and then putting into patients. It certainly is not something that is going to be a very near term events, but you have to plant those seasons when the right income please pick the food.
Understood. Okay, and then maybe a quick one cruise.
Just perhaps what we can expect in terms of additional milestones for when Youre.
Collaboration with Everest and search and maybe some fence around some timelines in terms of when we might expect some updates from that so.
Sure.
So as you know and just talk and his previous quarter, we did receive the $60 million milestone payment on ft approval from effort.
If you recall the total milestones around development in sales totaled two around $710 million. Those are based on launches of various trials participation global trials first patient in our regulatory approval in different countries and those detail.
Sales.
Were 8-K, when we when we did those when we completed that contract and there's a number from a massive milestone payments associated with sales and sales milestones as the product commercialized in various markets and then last but not least there that there the royalty milestones.
Ranging anywhere between 14 and 20% depending on various reduces revenue brought in.
I think that kind of the totality of what those milestones looked like Theres a lot of detailed there, which we obviously kenny and on this call, but I think that should give you a pretty.
Sure.
Hi, well, thanks, so much and again had so congratulations to you all it needed. Thank you see the Christmas.
Thank you very remote.
Thank you.
Our next question comes from Paul Choice of Goldman Sachs. Your line is open.
Hi, Thank you good afternoon, everyone and let me offer my congratulations on the great early launch as well.
My first question is Colorado and I was wondering if you could maybe help us understand what the timing might be for potential update in terms of your ongoing biomarker analysis across the various tumor types on on truck to and whether you expect any difference or how to think about potential differences between the math.
A static and.
Hi, driven populations.
And then my second question is for Brendan just on the on the penetration into the various settings could you maybe comment a little more and just what academic center utilization has been I know those typically take a little longer to get through PMC and so forth, but just sort of where you are in terms of targeting and how many of your target centers have adopted or utilize the drug. Thank you.
Okay. So I'll start with the true too because I don't have much to tell you. We obviously finally have a large enough collection and down a validated assay with which to assess true to levels.
I think that we're in the process.
Analyzing those data now from the sense and I don't have much tell tell you about it on of course, the ascent population unless a.
It was very advanced population and I think it will be a long time before we are able to extrapolate whenever finding we have from that population to an earlier population.
Very little information actually about truck to expression, we don't know how it evolves over the lifetime of the tumor we don't know patients start out with high choke levels and stay that way. So there is there are many many more questions about the true to target than there are answers and I think thats going to.
Take some time, even figure out in the advanced setting on exactly what what the messages.
So that's all I can say about 50 right now.
And anything else on others other solid tumor types.
I think 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 from the Urothelial group as well and we'll take a look at all of that and see if we can drive or extrapolate between the populations, but again these are.
Very advanced patients. These are bang samples and it's going to be very difficult I think it's Russ specific correlations.
Paul on your second question on uptake in the in the academic and that kind of split I mean, we've been pretty impressed with the uptick across both settings I mentioned, specifically the community oncology setting on usually we expect the academics to come on because they have a clinical trial experience.
What we've seen robust across academic and community what's interesting on the ACA in the academic side is.
Cope it had an impact there on the ability for different institutions on the academic side, even meet and have a formulary review in a PMT a 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 sense.
And certainly broadly speaking I think the the uptake in the academic.
Setting is very strong and.
From what we hear from feedback from the physicians in that the academic world there, they're very impressed with the profile of the drug so some slight bumps in that area with cobot, but I think we've we've managed to work through them so far.
Great. That's helpful color. Thank you again, congrats on the quarter.
Thank you.
Thank you.
At this time I'd like to hand, the conference back over the child Chen for closing remarks.
On behalf of the entire leadership team I'd like to thank you all very much what joining us. This afternoon, we look forward to updating you in the future no ongoing progress.
Ladies and gentlemen. This concludes the conference you may now disconnect. Thank you and everyone have a wonderful thanks.
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