Q2 2022 Seagen Inc Earnings Call
Good day and welcome to the CN second quarter 2022 financial results conference call. All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero.
After today's presentation there'll be an opportunity to ask questions to ask a question you May Press Star then one on your Touchtone phone to withdraw your question. Please press Star then two please note. This event is being recorded I would now like to turn the conference over to Doug Murphy, Vice President of Investor Relations. Please go ahead.
Thank you operator, and good afternoon, everyone I'm pleased to welcome you to <unk> second quarter 2022 financial results Conference call.
This afternoon, we issued a press release with our results.
Our press release and supporting slides are available on our website in the investors section events and presentations page.
Because on today's call will be rush's that'd be interim Chief Executive Officer, and Chief Medical Officer, Todd Simpson Chief Financial Officer.
Chip Romp executive Vice President commercial U S.
Following our prepared remarks, we will open the line for questions. We aim to keep this call to one hour and all that you limit yourself to one question to give everyone an opportunity to participate in Q&A.
Today's conference call will include forward looking statements regarding future or anticipated events and results, including the company's 2022 financial outlook anticipated product sales revenues costs and expenses.
Future developments related to legal matters potential clinical and regulatory milestones, including data readouts and regulatory submissions.
Potential marketing and reimbursement approvals and commercial performance.
Actual results or developments may differ materially from those projected or implied in the forward looking statements.
Factors that might cause such a difference include the difficulty in forecasting sales revenues costs and expenses.
Impacts related to the COVID-19, pandemic and the uncertainty associated with legal disputes.
And with the pharmaceutical development and regulatory approval process.
More information about the risks and uncertainties based by CGM is contained under the caption risk factors included in the company's quarterly report on Form 10-Q for the quarter ended March 31st.
2022, followed with the Securities and Exchange Commission and the company's subsequent reports filed with the FCC.
Now I will turn the call over to Roger.
Thank you Doug.
Good afternoon, everyone and welcome to our second quarter earnings call I.
I was recently appointed interim CEO and I am honored and privileged to lead such an extraordinary company.
Along with my season colleagues I am deeply committed to continuing our mission of bringing transformative medicines to market that make a meaningful difference in the lives of people with cancer.
<unk> has a rich history of oncology innovation and I would like to acknowledge place to golf as our founder he was integral to building the company that we have become.
Today, we are pleased to announce total quarterly revenue of $498 million. This represents growth of 28% compared to the same quarter last year.
This growth reflects robust commercial sales across our four approved products as well as strength in royalties and collaboration revenue.
We continue to progress our assets with more than 17 programs across our approved medicines and pipeline.
We remain focused on two strategic priorities. Our first priority is maximizing the global potential of our products through commercial execution supporting robust clinical development programs for future label expansions and leveraging our strategic partnerships to broaden.
Our geographic reach.
Our second strategic priority is to advance a deep and diverse pipeline as we look to bring additional medicines to market in the coming years, our financial strength and solid balance sheet drive internal and external investments to support our priorities.
Beginning with pads is a first in class ADC for metastatic <unk> cancer.
Net product sales were strong in the second quarter.
This was driven by continued uptake in labeled indications along with clinical trial supply orders, which Todd will discuss.
So it has become standard of care in the United States, where patients in the post PD one PD L. One station. It has now been approved in nearly 40 countries based on the overall survival advantage demonstrations in the global EV 301 trial.
Furthermore, we continue to expand our commercial footprint internationally and booked our first sales of pets in Brazil. During the quarter. We also secured approvals in Singapore, and Australia through our partner Astellas, who we continue to work with to commercialize this important therapy.
We were excited earlier this week to released positive top line data from cohort K of the EV 103 trial. This study evaluated passive in combination with Keytruda in frontline cisplatin ineligible patients with Unresectable locally advanced or metastatic <unk> cancer results from this try.
Bill showed a confirmed overall response rate to.
Independent Radiographic review of 64.5%. The median duration of response was not reached.
The combination had a manageable and tolerable safety profile.
These are patients with a very high unmet medical need and we are encouraged by these important results. We look forward to presenting additional data from this trial at an upcoming medical conference and we also plan to discuss these results with regulatory authorities with the intention of submitting an S. P. L. A to the F D. A.
Later this year to support the potential accelerated approval in the United States.
Further clinical development for passive continues the global phase III E. B three O two trial in frontline metastatic setting is on track to complete enrollment. This year. This trial enrolls both cisplatin eligible and ineligible patients irrespective of PD lone expression and is intended to serve as a confirmatory.
Trial in support of an accelerated approval.
In collaboration with Merck enrollment is also ongoing in two phase III trials assessing pads saving combination with keytruda in muscle invasive bladder cancer. In addition, we are progressing the phase one easy one O four trial, which is investigating pets, if monotherapy administered intravenously in BCG non risk.
Sponsored non muscle invasive bladder cancer patients and finally, we are exploring <unk> potential utility beyond that of cancer with our phase two E V. Two O two trial, which is studying the effects of pets at mono therapy in other Nixon for expressing solid tumors, our partner Astellas, who is conducting this trial.
Has obtained topline results in some cohorts and we will be jointly reviewing the results and discussing future direction.
Turning to Kaiser, which is our best in class tyrosine kinase inhibitor and is approved for her two positive metastatic breast cancer patients with and without brain metastases. We are pleased with <unk> performance in the second quarter. Despite the competitive headwinds, we're working towards additional European launches in 2022 and <unk>.
Work is progressing weak industry submission and reimbursement activities intended to expand <unk> reach in their territories at.
At the ESMO Gi meeting earlier this month, we presented results from the mountaineer trial that assess two kinds of plus trastuzumab in patients with previously treated her two positive metastatic colorectal cancer.
The combination of <unk> and Trastuzumab resulted in a confirmed overall response rate of 38% with a median duration of response of 12.4 months. The safety profile further demonstrated the combination was tolerable with only 6% of patients needing to stop therapy due to adverse events.
Based on the strength of these data we have submitted a supplemental NDA under the accelerated approval program in the United States, which has the potential for approval. In 2023. We are also conducting the phase III mountain, yet Oh, three trial, which adds to Kaiser and Trastuzumab to standard of care chemotherapy.
In the frontline CRC City. This is intended to serve as a confirmatory trial in the U S. For her two positive CRC and could also support global submissions.
In metastatic breast cancer, we recently completed global enrollment in her two client Oh to this study is investigating <unk> in combination with <unk> compared with tensile a monotherapy in the first or second line metastatic setting including patients with brain metastases.
I will now move on to Tim Dec. Our first in class tissue factor directed ADC approved in the United States for recurrent or metastatic cervical cancer patients.
Second quarter net product sales of <unk> was strong and reflect the high unmet medical need these significant clinical data and exceptional commercial execution from the CGM and Genmab teams.
The innovative 301 phase three monotherapy study is enrolling well and is intended to serve as the confirmatory trial in the U S and to enable global regulatory applications at.
At ESMO last month, we presented encouraging data from our innovative two a five phase two study evaluating <unk> and keytruda in the front line metastatic cervical cancer setting.
The combination demonstrated a confirmed overall response rate of 41% and a median duration of response that was not reached after a median follow up of 19 months. In addition updated data from the combination of chips deck and carboplatin in the frontline setting showed a confirmed oh.
Or a 55% with a median duration of response of $8. Six months. We are encouraged by these doublet results and innovative two O. Five is now investigating <unk>, plus carboplatin and keytruda plus or minus avastin in the frontline setting.
Results from these triple and quadruple combinations will inform our next steps.
Next to highlight isn't citrus, which through our collaboration with Takeda has become a foundation of care for CD 30, expressing lymphomas and is approved in over 75 countries.
Two important phase III et cetera trials was featured as oral presentations at ESMO last month. The first was echelon, one which showed that ADCETRIS in combination with a b D significantly improved overall survival compared with a BBB D in patients with advanced Hodgkin lymphoma the outset.
This combination reduce the risk of death by 41% with a P value of 0.009.
These results were recently published in the New England Journal of Medicine, and we also plan to submit the data to FDA this year, who possible inclusion in the label.
The second presentation was from the Phase III children's oncology group study a hard 1331 in pediatric patients with high risk Hodgkin lymphoma. This study met its primary endpoint of event free survival with ADCETRIS, plus chemotherapy, reducing the risk of disease progression by 59 per.
When compared to a chemotherapy regimen that included bleomycin. The pediatric patient data were included in an S. P. L. A which has already been granted priority review by FDA with a target action date of November 16th 2022.
These two studies emphasize the meaningful difference that a tetris could make in patients' lives.
There's such a member dose no D. V is a late stage novel her two directed ADC that utilizes Alba Dotan based technology, our clinical development program is evaluating monotherapy and combination approaches in a variety of cancers. We recently began enrolling into the phase two pivotal monotherapy trial in second line.
Line her two expressing metastatic urothelium cancer, we plan to initiate additional pivotal studies in bladder cancer and virtual or breast cancer over the next several months. We are also considering development in other her two expressing solid tumors, including gastric cancer.
Turning to our earlier stage pipeline given our robust R&D engine, we are advancing a growing number of drug candidates in phase one clinical trials across a range of solid tumors and hematologic malignancies.
Our ADC collaborator collaborators continue to make progress with programs that utilize our technology and.
Abbvie initiated a phase III trial in non small cell lung cancer with a C met directed ADC and Roche has now filed an application for approval of policy in first line D. L. B C. L. In the United States based on their phase III Polo X trial.
I will now briefly touch on our ongoing legal proceedings with Daiichi Sankyo as many of you are aware we received a positive jury verdict in April that Daiichi sankyo. Thank Joe had willfully infringed our 039 patent and we were awarded past damages of 41.8 am.
Millions of dollars, where sales have been hurt your through the trial date.
Despite the jury's verdict Daiichi Sankyo requested the court to find a patent unenforceable. We are pleased the court recently ruled against Daiichi on their request and entered a judgment in favor of see Jim based on the Jury's Award.
We intend to now requested the court to award a royalty for future sales have been her two through the end of the patent term in another favorable decision recently, the patent trial and appeal board of the U S patent and trademark office has again denied Daiichi requests to Institute a post grant review proceeding against Us.
Three nine patents.
We now await the arbitration outcome regarding ownership of the ADC technology used by Daiichi and in her two and its other pipeline a D C products, which we believe represents the most meaningful element of these digital methods as a pioneer and leader in Adcs. It is vitally important for us to do.
Send our intellectual property as we continue to drive ADC innovation.
Next I'll turn the call over to Todd, who will discuss our financial results and chip will provide an update on our commercial performance Todd.
Thanks, Roger and thanks to everyone for joining us on the call are financial results continued to reflect significant advancements made across the business today I'll briefly summarize our results and then discuss a few updates to our financial outlook for the remainder of 2022.
Total revenues were $498 million in the second quarter and $924 million for the first half of 2022.
Product sales were $432 million in the second quarter and $815 million for the first half of the year, each representing approximately 25% growth over the same periods in 2021.
These results reflect continued growth across our commercial portfolio of note had some sales in the second quarter of 2022 included $19 million in sales to another company for a combination clinical trial, but they are conducting.
Royalty revenues were $39 million in the second quarter and $67 million for the first half of 2022.
Growth in the second quarter was 8% compared to the prior year and driven by et cetera sales by Takeda as well as sales of pull a V by Roche and blend wrapped by GSK, both of which are Adcs that you see Gen technology.
Collaboration revenues were $27 million in the second quarter and $42 million for the first half of 2022.
These reflect royalties on sales of pad served by Astellas in its territories as well as other collaboration activities, including a milestone from Abbvie in the second quarter of this year.
Cost of sales were $106 million in the second quarter and $194 million in the first half of 2022. This included cost of product sales and royalties for each of our four brands profit share amounts owed to our collaboration partners Astellas and genmab as well as noncash amortization of acquired.
Our technology works.
Yes.
R&D expenses were $304 million in the second quarter and $602 million in the first half of 2022. This reflected continued to do an investment to expand the potential of our approved products and to advance our pipeline programs.
SG&A expenses were $220 million in the second quarter and $394 million in the first half of 2022.
This was driven by commercialization efforts, including investments to support country launches of <unk> in Europe , the ongoing Tim Dec launch in the U S and other corporate activities.
Regarding our financial guidance, we are increasing our et cetera sales guidance to a new range of $750 million to $775 million reflect reflecting strong performance year to date.
We are maintaining our guidance for pads seven to Kaiser and we are not providing guidance for <unk> at this time chip.
Chip will provide more context on market dynamics related to each of our brands in a moment.
Based on progress made by our existing collaborators and a new collaboration we are increasing our guidance for collaboration revenues to a new range of $50 million to $60 million.
Our guidance for royalty revenues remains unchanged, although we are monitoring the effects of foreign currency fluctuations.
With regard to expenses, we are maintaining our guidance ranges.
We ended the second quarter with $1 $9 billion in cash and investments our financial performance and strong balance sheet allow us to continue investing in our portfolio of business.
With that I'll now turn the call over to chip for an overview of our commercial performance.
Thank you Todd I am pleased to provide an update on our commercial performance, which set a new quarterly product sales record of $432 million driven by our four approved brands. We are pleased with the performance of our commercial portfolio of best or first in class drugs that have become important treatment options and now have treated approximately 100.
20000 patients across the globe.
<unk> second quarter sales were $124 million, a 50% increase over the second quarter of 2021, excluding clinical trial supply orders growth was up 27% over the second quarter of last year and 15% over the first quarter of this year.
Underlying growth continues to be primarily driven by use in the post checkpoint setting where passive is a U S standard of care.
We are pleased with the recent positive top line data reported from the EV 103 cohort K trial. As a reminder, there are approximately 20000 total addressable patients in the frontline metastatic setting in the U S with about 80% of these being drug treated 40% to 50% of these patients arent eligible for.
Platinum based chemotherapy, which represents the population studied in cohort kit.
Moving onto the Decatur second quarter sales were $89 million, a 7% increase over the second quarter of 2021.
You will recall that our 2022 outlook for <unk> assumes the impact of competitive pressure from <unk> U S launch in the second line setting and inclusion in guidelines and pathways. This remains our expectation despite seeing modest impact in the first half of the year.
With her choose approval in this setting in May we continue to anticipate a shift in how these regimens are sequenced with increased use of in her two resulting in a delay of patient flow into the third line plus setting where to Kaiser is mostly used we continue to be confident in the case of strong value proposition in the second line plus setting.
Especially for patients with CNS involvement.
In addition, following the positive Mountaineer study results, we look forward to a potential label expansion in the U S into the second line plus setting in combination with Trastuzumab in metastatic colorectal cancer patients at some point in 2023.
Although a modestly sized patient population it represents a high unmet medical need.
As existing approved colorectal cancer therapies typically offer limited response rates.
Et cetera second quarter sales were a record $202 million, an 11% increase over the second quarter of 2021 post <unk>. We are actively promoting the unprecedented overall survival data from the echelon one trial and are pleased with the positive reaction we are seeing from prescribers.
And finally, <unk> sales were $17 million for the second quarter. While this initial indication in metastatic cervical cancer patients represents a modest opportunity. We are very pleased with the positive reception from physicians and patients we've seen to date.
The CE Gen and Genmab commercial teams are managing the eyecare visit requirements with best practices being shared between clinics. We continue to promote this important treatment option for patients with such high unmet need now I'll hand, the call back to Roger.
Thank you chip.
Regarding recent media reports focused on potential M&A, we do not comment on market speculation and we will not respond to questions on this topic during the Q&A session Inc.
In closing I am very proud about second quarter financial and commercial performance as well as our development accomplishments throughout the year.
We recently reported pivotal data from trials for ADCETRIS, Pat said and to Kaiser that are each intended to support potential label expansions Sejant is well positioned to continue advancing our mission to deliver cutting edge innovation that positively impact the lives of people with cancer.
With that we'll open for your questions operator.
Please open the line for Q&A.
Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Okay.
Yeah.
Okay.
Our first question comes from <unk> Richter from Goldman Sachs. Please go ahead.
And thanks for taking my question any updates here on the timing for an arbitration decision and any color you can provide on why the judge has not yet well done <unk> royalties and the infringement case. Thank you.
Hi, Thank you.
And as we see right now and Oh, yeah.
Best estimate is around mid year.
That continues to be our guidance with regards to timing.
As a reminder.
Spending is controlled by Goldman Sachs and the timeline.
Oh yeah.
Any thoughts.
On that.
We are in the major carriers and so we are expecting that results come out.
Yeah.
And then sell being with.
With respect to the Texas matter.
Normal process.
The judge has entered into an award.
Final motions with the court for the judge to now consider future.
Future damages. So just procedurally that takes a little bit of time, but that's something that we are working on right now and expect to happen shortly.
Thank you.
The next question comes from Matthew Harrison from Morgan Stanley . Please go ahead.
Great. Good afternoon, thanks for taking the question.
I guess can I can I just ask on cohort K I think one of the one of the key factors people are trying to understand it.
Potential duration of follow up in that study and what that implies in terms of potential durability. So I don't know if you're willing to just tell us what the median duration of follow up was at the time that you reported those resolved and then just secondly on two O. Two for Pat can you just remind us of.
The different cohorts in which cohorts, maybe you're potentially most excited about thanks.
Thanks for the question.
A replay of this cohort.
We're excited.
And then just a minute.
As soon as we can.
But as I'm sure you understand that we are limited in how much comes I'm talking about in their press release.
I need to maintain confidentiality until it gets presented to the meeting.
Can you just hold off number once you, but what I can say, it's just in broad strokes spending starting to enroll in January of 2020.
We declared last patient enrolled.
In October of last year.
And the data in mid July timeframe. So you can get some sort of sense.
The change in the trial.
I'm quite confident and its my journey otherwise like ourselves.
So at this point, but unfortunately have to St. James I'm told me again.
At the medical meeting.
With regards to Toronto.
There are a number of cohorts we are unfortunately, not going to be on the sandwich, which cohorts on top on themselves, but they are.
Some points based on channels.
Putting things like cancer.
So breast cancer gastric cancer, and perhaps some others.
Thank you.
The next question comes from Cory cast them off from J P. Morgan. Please go ahead.
Hey, good afternoon, guys. Thanks for taking my question want to follow up on cohort K as well from a regulatory point of view can you kind of discuss the type of discussions you've had with the FDA prior.
Prior to the release of data from cohort K that that this particular study with robust results in hand, which you seem to have now could be enough to form the basis of an accelerated approval, especially with Pat the monotherapy is technically the control. Thank you.
Yeah. Thanks, Thanks for the question Corey.
Just to remind you that all.
On the basis of cohort.
Which was the first data set to be presented with this combination we will.
But we're able to garner brain.
And that's an on track smaller seamless to the agency.
It is getting to that place.
Cohort.
The time, they went to somebody to answer them.
And subsequent to the oncology.
Coupled with the specific intent.
Yes.
The data supports to looks like celebrating approval, so without getting into any of the details and the sequence of events is obviously.
In generation that initial data that we had conversations with the agency.
We were granted breakthrough therapy designation.
Okay.
The monotherapy is primary purpose.
And supply centers.
Contemplation.
A combination.
Okay.
Yeah.
That's helpful. Thank you Roger.
Yeah.
The next question comes from Gena Wang from Barclays. Please go ahead.
Thank you for taking my questions are regarding your fishers combo with Campbell in solid tumor initial data late later this year.
I'm wondering if you can give a little bit more color.
How many patients.
What are kind of solid tumors and will be a flasher you'll be looking for.
Yeah. Thanks for the question.
Very interesting area.
We're exploring with Suntrust.
The population just to remind folks.
These are patients who have payments and responded in the Montana anyone on PD, one inhibitors that have subsequently progressed.
And the scientific basis for this.
That et cetera.
Amongst other things T regulatory cell module.
It happens I can't make them themselves, which maybe one of the mechanisms by which for anyone.
<unk> inhibition in the past.
Can be over expressed in 10 minutes.
Jim sorry, eliminate them population that may allow.
Recovery sensitivity tend to PD one inhibition.
PD one inhibitors.
And then Tim but the two diseases that we're interested in.
Good reason one is in melanoma.
As you know PD one inhibition.
Coal melanoma therapy.
And then the other is in lung cancer. So both of these tenants are immune responses.
The initial period and so those are the two cohorts that wins internationally. We can't give you any further details as to regards to numbers and you know exactly when they might come out in the data, but it is an area for us so stay tuned for that.
These results when you can get them out yet.
Thank you.
The next question comes from Andrew Berens from S. V. P Securities. Please go ahead.
Hi, guys congrats on the bulk of beats and raises.
Two questions for me.
I was just wondering how we should interpret your comments about some of the EV 202 basket trial cohorts reading out.
Not being a top line release about the findings shall we look at tea leaves or the Ouija Board and then a question on arbitration on the district trial it sounds like the district Court's decision.
Future royalties could take some time is that something you think that the arbitrator might want to see is collaboration.
Thank you and number one.
Congratulations.
Many of our products.
Our quarter was outstanding.
Many levels I. Thank you for that comment.
With regard to understanding.
This is very recent information.
Astellas is.
Running the trial.
And so the information is available it doesn't erode tiered and then some next steps in terms of when we present the data.
Timing and all of that song.
Stay tuned on that on that aspect.
Instead, we will onboard in a reasonable period of the plan.
Regard to.
The masses around the arbitration, perhaps I'll ask Todd to comment sure. So thanks for the question I you know again remember there are two separate matters.
The Texas case to the patent infringement or the jury award, 9% royalty and we're now asking for the judge to rule.
Award us future damages, we think that as I mentioned earlier, we will take.
A matter of bonds. Some additional time the arbitration on the other hand is a question of ownership.
<unk> to our EC <unk> technology that we believe are embedded in some of the work of Daiichi did with our systems.
So it's a <unk>.
A separate matter, we don't think they're necessarily tied together and just based on what we know when which is certainly everything we we do expect that the arbitration won't read out for.
Anything further from the Texas Court.
Okay. The reason I was asking.
Just there'll be damages potentially awarded from the arbitration matter.
Matt I was just wondering whether the arbitrator looks at the 8% you got retroactively them maybe proactively.
It's a good question I think is perhaps one of the things will be looked at but we've provided a whole different.
Damage taste of your arbitration drugs that we think will be sufficient in order for him to make a ruling.
Okay. Thanks for letting me ask more than one question.
The next question comes from Michael Schmidt from Guggenheim. Please go ahead.
Hey, Thanks for taking my question Roger I had one on EV three O two which you said is the confirmatory study for cohort K.
My question is what is the regulatory bar for overall survival now in frontline bladder cancer with Oh about MTO maintenance being routinely used in pads have obviously, that's well in later stage patients.
And how confident are you in the EV 302 trial design and powering assumptions now with cohort K data being available to you.
Michael Thank you that's a that's a great question.
With regard to the outcome.
Outcome.
On the experimental arm.
We do have the luxury now of two datasets.
When she has been indicated in the press release are generally consistent with each other so competence around experiments.
In terms of its great potential.
Outcomes based on and based on that data and so the question becomes Halloween.
Hum.
And just to remind you.
As you know.
In defence intervention.
Additionally.
As a maintenance therapy is not for everyone.
So.
The.
Patients have to respond.
Did not.
Do not progress and it wasn't didn't really map.
Attunity.
And our.
EBIT for your time everyone.
The populations alone are not bad.
Obviously, they won't be it doesn't matter.
In the trial.
There'll be other PD one inhibitor use.
Again, as I sort of see.
Thanks again.
Okay.
So from our perspective as you're asking the question are we confident that we have adequate power.
So the outcome.
In terms of differential.
Yes, I think the answer is yes the outcomes.
We think the trial is big enough.
Reminding you that it's about one trial, that's something I think eight to 900 patients.
And we have dozens of others.
And to what the experimental arm.
It is a question of how it works.
Uh huh.
Okay very helpful. Thank you so much and congrats on the quarter.
Thank you guys.
The next question comes from Geoff Meacham from Bank of America. Please go ahead.
Hey, guys.
Congrats on the quarter I guess I had more of a commercial question wanted to kind of.
Here to take your temperature they used to be.
What's happened or what's changed commercially or.
So then in Chicago in particular versus what your original assumptions were to start the <unk>.
The year and then the second part of that is just on the industrial side of things just wondering what the feedback was on the recent data on O S for for echelon, one and maybe what kind of commercial impact do you think that could happen down the road. Thank you.
Yeah, Thanks, Jeff and thanks again for Paul Paul Congrats.
With regard to I think I understand your question is.
Hey.
The beginning of the year, we obviously gave guidance that we had some.
Our emphasis on the ones you want to talk about guidance.
How do you see that compared to where we are right now.
Yeah.
About the brands.
I think that's what I thought.
I'll ask chip.
To respond please.
Sure Jeff Thanks for the question so well.
Well, we're pleased with the quarter. It was a very strong quarter across all of our brands.
At the end of the day, it kind of reaffirms our thinking around guidance, where we think we are on track with regard to our guidance recommendation, which was at the beginning of the year, Pat So I've had a very strong quarter at 15% growth over the first quarter.
In addition to that we saw very strong et cetera growth. So as you mentioned.
We do attribute this to the E. One data that we released the OS data we've seen a significant.
<unk> response to that data physicians are pleased with it and I think it is reaffirmed some of the messaging that we've been getting over the last couple of years.
In addition to that we did see a rebound in patient diagnosis and in Q2.
With regard to newly diagnosed AML patients, which was close to pre pandemic levels dependent and kind of had an impact on et cetera that we spoke to that in the past with regard to the case up to a place that has held up very well.
It is a valued treatment option for physicians and particularly for patients with CNS involvement and so we're pleased with the performance of the queso.
Continued to maintain our guidance on it and we'll continue to monitor the market closely.
Yeah, maybe I'll just add.
The dynamics that we included in our guidance are as follows. So first forward to cards and chip mentioned, we were expecting to see her to approval, we're really happy with the way. The brand has performed in the first half of the year, we only now seen.
Hertz to approved it was approved I guess late in the second quarter. So we're still watching the effect of that but as we talked about when we gave our guidance we do see.
Little bit of a disruption in how the drugs are sequenced in that setting so.
To watch and see how that plays out but again I think we're really pleased with how the first half of the year has gone and then with respect to pads.
We weren't expecting growth from cohorts you know we're also looking at the use of <unk>.
Maintenance and how that informs patients that come onto the.
The label for pads. So you know all in all things are playing out the way we thought they would.
When we gave guidance and again I think chipset.
Really happy with how the brands have performed in the first half of the year.
Yeah.
The next question comes from Gregory <unk> from RBC capital. Please go ahead.
Great. Thank you very much for taking my question and congratulations on an on the quarter and maybe Roger or perhaps more of a higher level question you acknowledge the interim CEO role at the top of the call, perhaps I could just ask you to comment a bit about what you're learning about the organization the culture and the progress to date as you think about.
<unk> future from the interim CEO standpoint, thank you very much.
Yeah. Thank you for the congrats and thanks for those questions.
I have to say.
I am energized and this company is really interesting.
The workforce.
All of the employees will remain focused on Anastasia mission, which is to try and make a difference.
The lives of cancer patients and.
We've obviously had.
We've had.
Excellent execution.
The first half of this year.
And is it is I'd get energized honestly by them by the employees and their enthusiasm.
Commencement and their desire to make adjustments in that area.
How much of an environment as it was experienced in Amsterdam.
Our nation I have nothing but positive things.
Do you think can say about the low and the company has it has I saw there was a culture in this company, which is very interesting to us.
Absolutely.
Plan to maintain and retain.
As we grow and as we essentially scale for what is it.
Ahead of us.
And my focus right now as interim CEO .
Keeping the business moving on this great right.
Yes.
Thanks Roger.
The next question comes from Stephen Willey from Stifel. Please go ahead.
Yeah. Thanks for taking my question and congratulations so maybe just a follow up I guess on the last question. So.
I know Roger you are holding the interim CEO role here, congratulations, but I think there is an ongoing search for.
A permanent CEO and just wondering if you could provide any commentary just with respect to where that process is and what timeline might look like and then I just have a quick guidance follow up.
Yeah. Thanks for the question.
It's an important one.
We've indicated the board has initiatives such as.
This is a great opportunity for any one of them.
So what happens to land them all.
And so in terms of timing, yes, we have we have our sales of St. We have plans in place.
It does not necessarily an urgent thing to do we are in great shape.
So I think we have the time to look for.
The ideal candidate.
What type of company that we are and the mission that we're on and so there is no there isn't a clear guidance on timing other than to indicate that the process has begun.
We look forward to reviewing cabinet.
Okay. That's helpful. And then maybe just quickly for card. It doesn't look like the infringement awards included and any updated guidance and just.
Just curious if that's a function of that being subject to some kind of appeal or if you could just provide any commentary on that thanks.
Thanks for the question. So it is not it's not included in our guidance well, we've had a positive jury verdict there've been.
Legal manoeuvrings to try to have this overturned.
Nicely I think the court continues to find in our favor. So we're feeling very good about the award, but we haven't recorded anything yet in terms of.
Payments or damages.
There was an accounting framework, if you will that we need to apply which we're doing.
<unk> gotten to the level, where you've recorded anything in their report starting point of our guidance as you mentioned.
Great. Thanks for taking the questions.
Yeah.
The next question comes from Andy say from William Blair. Please go ahead.
Oh, great. Thanks for taking my question really glad to see the strong commercial performance and clinical success.
Quarter.
So regarding the system that they do it and I'm just curious about how you think about exploring the opportunity there maybe for a white space perspective.
And and also kind of kicking into a couch.
Other therapies out there that could fill that unmet medical need thank you.
Thanks, Andy.
That's a great question so.
And as we've indicated in the whole assessment of adulthood.
As a novel Hudson directed antibody on the front end, which has been optimized we believed for an agency type construct.
It uses a dozen technologies.
There is somebody else.
I'm trying to think of.
With regard to the opportunity.
It is a broad potential for how do you mean.
Obviously, we're fortunate.
Data in hand.
Concept Raymond James in China generated in China.
In diseases such as.
Cancer.
And breast cancer.
And to some extent in gastric cancer and just to remind you that they have approval in.
But in a number of diseases in China.
With regard to we're always driving I believe already.
I am pretty clearly.
Okay.
The first trial and you're a senior.
Senior cancer.
And all our clinical trials with patches.
Tom.
Lifting data enrolling patients from a you know a couple of western population.
To be more amenable to review by agencies, such as the FDA. So we are committed to your residual cancer and our first trial.
Looking for an accelerated approval approach and as you know going down that path.
And basically entails a confirmatory trial.
Because that's that's what's required for an accelerated approval and so will we will be conducting at least two trials in U S. Haynesville cancer, one mono therapy, we haven't disclosed what our plans are with regard to what our consultants look like and obviously as we always do.
We conducted a.
Randomized phase III, it's not just the consultancy trial that gives the opportunity is.
Positive.
Quite honestly approval basically around the world.
Gotta cancers, and Scott second area.
As such.
Is breast cancer.
And obviously in the results that were Ms. Angela Hertz can be something standing.
Points, the way to the potential for an ADC, which is not dependent upon.
Some holes addiction to the pathway the pathway itself doesn't necessarily have to say that we just have to be there such that the agency can they internalize and that's why in ADC has a possibility to have once again.
11 population. So we're very interested in that and one of the Differentiators pass.
Which we believe is important and it's like okay.
Thanks to this is there.
He is something important going on when you combine <unk> with Dougherty.
Did you see for the PD, one inhibitor symphony that as opportunities.
That is an element.
But I think we will explore.
With TV and various diseases, including potentially.
Just in gastric cancer and so on wherever we think that's appropriate.
That is something like a PD one inhibitor and then lastly, I would say just sort of mind you. We do have to concept. So we have another hotel asset.
That is available and we are thinking through.
Walk clause.
<unk> development program looks like.
We didn't cooperate.
Combination of <unk> and so there's a lots of work ahead of US I think we're excited by the program. There's lots of opportunity we're trying to be thoughtful about how to navigate what is.
The competitive landscape.
We will bring we will bring more plans forward has been mature.
Yeah.
Thanks Roger.
Sure.
The next question comes from Joe Catanzaro from Piper Sandler Sandler. Please go ahead.
Hey, guys. Thanks, so much for taking my questions. Maybe just one follow up on cohort K. So so Roger you mentioned that there's a monotherapy arm within that trial. Just wondering if you guys have taken a cut.
Of those monotherapy data, yet and if so when would you expect to present those data and if not when would you expect to take a data cut.
Thanks, Thanks for the question so.
When a car it's a randomized trial so both arms contemporaneous.
And anytime we do an analysis and then the circumstance, even though there's no inferential statistics between the two arms.
The randomized when you take a complaint data cuts.
So we will be presenting all of the daily we have and it is a rich dataset.
I'll include the monotherapy and the combination at a medical meeting and we will get to.
And as soon as possible.
Okay got it that's clear thanks, so much.
The next question comes from Jay Olson from Oppenheimer. Please go ahead.
Oh, Hey, thanks for the update and congrats on the quarter can.
Can you comment on any read across from Roche's teach it antibody to your ticket program and.
Remind us what are some of the important differences between your see ticket and tiered Golden map and maybe comment more broadly on any plans to expand your key technology platform. Thank you.
Thank you for all the programs and the question.
Great one so.
Our point of view, what is the level of conviction around.
The pathway and the attention pathway.
There was obviously enormous initial excitement.
Roche generates embed randomized outcome, which was which was very encouraging initially in the phase two we haven't seen the data. So it's really hard for us to actually make any judgments about the body.
The treatment effects.
They are insane.
The science is strong.
We really like our molecule.
Franchises and that's basically because the backbone is in an activated state.
With regard to me.
Consultation.
What it does is it essentially increases the potency of all of the interactions.
With a bank partner may have with various other cell types and so we've got a lot of preclinical data that I think shows that we have a differentiated intentions, but maybe.
Preclinical component turns out to be useful in the clinic.
You know put us in a in a very.
Strong position with regard to where we are.
We are still in phase one.
We are in.
We are focusing on determining what does.
That dosing schedule that we would take forward and.
And we are also exploring.
Signals are in there.
These diseases.
Such as gastric cancer, and the partners, which I think is an interesting area for us to look at and we've also begun.
Or a collaboration.
Let's start with anti PD, one inhibitor just to evaluate.
Tianjin together with a PD one inhibitor may look like.
The point that team.
The potential to add scale is perhaps.
Not as positive as it was a whole I think the point.
So I'm glad we're still committed to evaluating a drug like we have the potential for the franchise in the phase one sets us up to try and get an understanding of whether that actually doesn't occur and then obviously the opportunity depending on what we see from all sides. One presents itself to move forward.
Okay.
To be very much.
The next question comes from the Kiang shoe from bearing Berg. Please go ahead.
Great. Thank you I like to add my congrats as well.
IRA.
Cohort K data in terms of the accelerated approval.
And at.
They try out the agreement with the FDA on the accelerated progress.
April 2020, and then in August .
2021.
Hey, Brandon first line patients, who are who are not eligible for any platform.
Treatment. So do you see any risk regarding the et cetera approval only being granted too.
To flatten out the algebra patients and the potential approval for our plan.
Okay.
You know how much of a patients mostly weighted towards the U S. B.
And for me now.
Okay.
So there was a fair amount of background noise.
I'll do my best.
Yeah.
What youre asking is quite a nuanced around international.
Paul.
With that label of them telling them eligible population.
The population we studied on.
From the point of view of the expected outcome from our side.
Really strongly that we will get it.
The data are compelling to the agency and they agreed that this is something that shouldn't be a trend we expect to see.
The invitation to match the population that we enrolled and just to remind you.
This platform ineligible.
Installation and the definition of what's happening there, which obviously is clearly stages in the protocol and we project that is about some.
Somewhere between 40 and 70%.
Patients with frontline.
Metastatic uveal cancer.
And so I don't know if I.
I answered your question, but I didn't hear it all but that's our expectation is that they'll be cisplatin ineligible and that doesn't limit chips and carboplatin eligible.
And it was.
You did answer my question.
Yeah.
The next question comes from Ren Benjamin from JMP Securities. Please go ahead.
Hey, good afternoon, guys. Thanks for taking the questions and congratulations on a great commercial and political.
Quarter.
Maybe just looking at et cetera.
Definitely wouldn't have predicted that etcetera split outperformed in terms of.
Revenues you know maybe some of the other products can you talk a little bit about what kind of market share you have across the indications in which ones kind of remaining you have the potential for significant growth.
Just thinking about the commercial products with Takeda as you think about sequencing you have a sense as to the clinical benefit to Kaiser might provide.
Provide when it's used subsequently too and her team with relapsed or refractory patients.
Yes.
Yes.
And again I appreciate the comments on the quarter.
With regard to some quick comments and then I'll hand, it over to jump to make to make myself.
Response.
This is an amazing drug I mean here, we are just get on the market 10 years right now shown survival.
And its primary indication, which is hodgkin lymphoma, and we continue to develop the drug.
We are interested in seeing.
If we can find a place for its interest in the relapsed.
Population.
So it is an amazing it is an amazing drug.
I think I can just actually make some comments about the Kaiser which is do we know what causes it looks like post hunting I think that the answer to that is no because we haven't got data.
Expectation would be because.
In terms of tyrosine kinase inhibitor.
But.
Mechanistically is completely different from.
Tom anything like that.
And provided that one can pathways all same thing, it's still relevant to the tumors addicted to that path.
Isn't it.
At any stage regardless of prior exposure.
Potentially bring value, but you don't have to tell you I don't think support.
To demonstrate.
So Paul do you want to comment on them.
Yeah sure Roger So we are interested to have a very strong quarter.
The overall survival data is meaningful data, it's important data for both physicians and patients. The teams have been executing very well in getting that information out we feel that there's continued opportunity for.
For growth with regard to et cetera, and its labeled indication in frontline.
We are a standard of care in frontline therapy now.
So I think there's a there's a good platform for us to continue to build off of with regard to queso to cases viewed as it is a really important option.
For physicians and particularly for patients with CNS involvement we spoke on other calls and in the past regarding the dynamic nature of the breast cancer market associated with entries into it we continue to monitor that market very very closely but we're pleased with how the peso has held up with regard to its revenue production.
We continue to look for additional opportunities with regard to that from a development standpoint, as well and we'll continue.
Can you do to execute across to the label that we have.
Great. Thanks, guys.
The next question comes from Amit <unk> from Needham. Please go ahead.
Yeah.
Great. Thanks for taking my question and congratulation on the quarter.
Independent of data, let's say that's the key.
It's not a follow up on Netcentric.
Given our positioning.
Position in both frontline and second line, what do you see as a growth opportunity in Hodgkin lymphoma from here.
You do have a couple of programs.
And if you could.
Talk to the twin excites you more in terms of growth and then a follow up on Daiichi Sankyo arbitration. When you get the decision are we also going to get a decision on them you know what the remedy would be and instead of quantification you know whether its royalty or any other sort of payment that would be huge.
Two season or will that be something that gets determined down the line. Thank you.
Thanks for the question and thanks for the.
The comments.
With regards to incentives I think I'll I'll give a.
A quick set of comments to your.
Texas continues to grow as you can see and so there's still opportunity in frontline Hodgkin lymphoma in the advanced setting the stage III Paul.
As you know now with an overall survival signal commercially in chimps team will be looking to make sure that any pause or something.
That needs to know the data and I understand you know.
What the possibilities are interested as part of the frontline therapy is aware of that that does represent.
Some growth of course, the pediatric component, which means indicating we have submissions.
All potential approval into a successful there and some modest opportunity, but that remains an opportunity Nevertheless, and an important one and this is in high risk culture kind of thought about.
We're very interested in the earliest stage Hodgkin lymphoma, and we are interested in novel regimens.
I wouldn't describe these as label, enabling but we are certainly signal seeking.
The combination of potential volume out.
Together with an anthracycline, that's causing a in 19, so we've got a lot of effort going on.
Looking to what to look to see what is that next generation of therapies. We believe we do believe that ADCETRIS PD one combination.
It may well lead the pack in terms of what possibly could be considered for laser development with regard to D. S. I think I'll turn it over to Todd for some comments.
So thanks for the question. It's a good question Thats. One. Unfortunately, we don't have a clear answer to you know obviously what would be nice would be a ruling in our favor with your own award awarding us ownership of the IP and a pathway forward with respect to what that means in terms of that.
Images.
Fortunately, we don't we don't know how the judge is going to rule and we don't know to a degree a ruling.
Cover all the unknowns it could be.
Quite clear and easy or it could be.
A matter of CGM has ownership you guys got to figure out what that means.
Product standpoint, so you know it's a great question. Thanks for it we just need to kind of wait and see what happens there.
But we believe we have a strong case for that we're hoping for a very clear and readily interpretable outcome.
Alright, thank you.
Due to time constraints. This concludes our question and answer session.
Like to turn the conference back over to Doug Mcvey for any closing remarks.
Thank you operator, and thanks, everybody for participating in all this afternoon I have a great rest of your day.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Yes.
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