Q3 2023 Lantheus Holdings Inc Earnings Call
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Good morning, welcome to the last year's third quarter, 'twenty, two or three financial results conference call.
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I will now turn the call over to your host for today, Mark minority Vice President of Investor Relations Mark.
Thank you good morning, and welcome to today's call with me are Mary Anne Heino, Our CEO, Paul Blanchfield, our President and Bob Marshall, Our Chief Financial Officer.
<unk> will begin the call with introductory remarks, and then turn the call over to Paul to provide a strategic and operational update.
Bob will cover our financial results and provide updated guidance Maryann will provide closing remarks, and then we will open the call for Q&A.
This morning, we issued a press release, which was furnished to the Securities and Exchange Commission under form 8-K reporting our third quarter 2023 results.
The release and today's slide presentation or in the investors section of our website Atlantica is dot com.
I would like to remind you that any comments made during our call. Today could include forward looking statements actual results may differ materially from these statements due to a variety of risks and uncertainties.
Please note that we assume no obligation to update or commentary or any forward looking statements, except as required by applicable law, even if actual results or future expectations change materially.
Please refer to our SEC filings for a detailed discussion of these risks and uncertainties.
Discussions during the call will also include certain non-GAAP financial measures.
Reconciliation of these measures to the most directly comparable GAAP financial measures is also included on the Investor section of our website.
It is my pleasure to now turn the call over to our CEO Marianne. Thank.
Thank you Mark and good morning to everyone. This was another terrific quarter for Atlanta, Yes, we reported revenue of $319 9 million up 33, 7% year over year and progressed, our internal R&D and our business development efforts to expand our pipeline.
I am proud to report we have impacted the lives of more than $4 7 million patients a year to date.
We believe our market leading position in P. S M a imaging and our advancing pipeline combined with our unique capabilities will continue to support our position as the leading radiopharmaceutical focused company.
Polaris I is the clear market leader in PSM eight pet imaging.
Growth during the quarter was driven by brand preference for Polaris high due to its clinical and commercial value proposition.
We believe Polaris by offering the best combination with our proprietary P. SMA targeted law again, and the F 18 isotope.
Turning to the total market opportunity, we estimate the current addressable market for the <unk> pet imaging agents to be $1 6 billion and believe this market potential will grow to more than $3 billion by 2028 as such we remain encouraged by the current and future growth potential of clarify.
PMT Tuesday, or zero to our investigational P. S may targeted radiotherapeutic asset represents another significant opportunity for growth within our prostate cancer franchise.
PMT to series a year or two is designed to treat patients with metastatic castrate resistant prostate cancer or <unk> see our PC, who have progressed following treatment with an androgen receptor pathway inhibitor or a RPI. We are excited about the progress we have made with our partner point Biopharma and look forward to the top line data from that.
Phase III class Splash trial in fourth quarter 2023.
As we consider the radiopharmaceutical landscape, we view the proposed acquisition of point by Eli Lilly is further validation of the opportunity we see for PMT Tuesday every day, or two and PMT Tuesday, or Z or three and the increasing role of Radiopharmaceuticals and life Sciences.
In addition to prostate cancer, we have a number of exciting assets, including P. N T 2003, or late stage radio therapeutic product candidate for neuroendocrine tumors. Another asset is MK 60 to 40 are investigational Tau imaging agent intended to assist the diagnosis and staging of Alzheimer's disease patients.
Which was recently granted fast track designation by the FDA and.
And finally, our fibroblast activation protein or FAP targeted pet diagnostic imaging agent is being clinically investigated in multiple tumor types.
To supplement our ongoing R&D efforts, we will continue to leverage our significant radiopharmaceutical expertise and resources to target business development opportunities.
With that I'll now turn the call over to Paul.
Thank you maryanne and good morning, everyone.
During the third quarter clarified delivered sales of $215 4 million, representing almost 50% year over year growth.
We attribute this strong performance to the prostate cancer communities recognition of clarifies clinical and commercial value.
Year over year growth was driven by existing accounts, new accounts and additional Pms activations.
Sequentially growth was again driven by our existing accounts offset by seasonal trends consistent with those reported across the health care sector as well as well as greater holiday impact and one less selling day.
This resulted in relatively consistent weekly dose demand in June July and August followed by more robust growth in September which carried over to October.
We expect Polaris <unk>, which has been used in more than 250000 scans since launch to maintain its position as the number one ordered P. SMA pet imaging agent because of three main clinical attributes.
Polaris <unk> delivers reliable diagnostic performance with accurate detection rates without a high false positive rate.
Second a robust pivotal clinical data shows change in intended management in patients with Biochemically recurrent prostate cancer.
Third Polaris <unk> demonstrated consistently high reader agreement and reliability in our pivotal trials.
We also believe the adoption and utilization of clarify are further supported by our commercial value proposition, including Polaris <unk> as the number one ordered PMA pet imaging agent in the U S and is a proven diagnostic backed by real world experience, including an over 250000 scan.
Across 47 states.
Widespread availability with Polaris <unk> being the only <unk> pet imaging agent that is available through a diverse multi partner F 18 network, which ensures convenient and reliable supply.
And broad market access with more than 90% of covered lives having access to P. SMA pet with clarifying.
For these reasons, we believe clarify will continue to be the clear market leader in PSM eight pet imaging.
We are encouraged by the recent developments in the reimbursement landscape in July the centers for Medicare and Medicaid services or CMS put forth several proposals for comment regarding possible changes, including separate payment for diagnostic radiopharmaceuticals.
<unk> along with numerous industry organizations submitted comments and we expect CMS to publish final 2024 regulations shortly.
Simultaneously, we continue to collaborate with industry and advocacy organization to past defined act to ensure all prostate cancer patients continue to have access to innovative radiopharmaceuticals, including Polaris Sai.
Regardless of the outcome of the CMS regulations and status of the fine.
We are confident in Polaris <unk> future growth prospects.
We see a significant growth opportunity for <unk> imaging.
We believe the current addressable market remains about 350000 scans or $1 6 billion.
We have updated our estimates for the total addressable market to be approximately 600000 scans are more than $3 billion by 2028.
To realize this potential we anticipate radio ligand therapeutics will move into earlier lines of therapy, including bolt pre chemo M C RPC and hormone sensitive prostate cancer, which would increase the need for PSA MA pet imaging for bolt patient selection and monitoring.
Additionally, we expect to see increased adoption of <unk> pet imaging in the intermediate favorable patient population as physicians realize its clinical benefits and additional data is generated.
Finally, we expect the incidence and prevalence of prostate cancer to grow approximately 2% to 3% per year.
Due to these factors we believe there is significant opportunity for clarify to growth in both the near and long term.
Switching to our Microbubble business definitive maintained its strong momentum with third quarter sales of $67 3 million up almost 11% year over year, we expect increasing procedure volumes and our promotional efforts to enable sustainable growth.
We continue to work closely with our partner <unk> Biopharma to progress PMT to zero zero to clinical and regulatory manufacturing and commercial readiness work streams, including establishing an expanded access program otherwise known as a compassionate use.
We look forward to top line Splash study data in the fourth quarter of 2023.
We have also seen positive developments for MK 60 to 40 are clinical stage pet Tau imaging agent intended to assist the diagnosis of Alzheimer's disease.
During the third quarter, we signed agreements with four prominent pharmaceutical companies to provide M. K $62 40 as a biomarker.
With these additional agreements MK 60 to 40 is now being used in more than 90 active clinical trials.
We believe that Tau imaging has the potential to play an important role in patient staging selection and monitoring for future treatments and could be a surrogate endpoint for treatment efficacy.
I will now turn the call over to Bob.
You, Paul and good morning, I'll provide highlights of the third quarter financials, focusing on adjusted results unless otherwise noted.
Revenue for the third quarter was $319 9 million, an increase of $80 7 million or 33, 7% over the prior year period earnings per share for the third quarter were $1 47.
An increase of 48 or 48% over the prior year.
Turning now to the details beginning with radiopharmaceutical oncology. The category contributed revenue of $216 3 million up 49, 5% year over year with Polaris high at $215 4 million with consistent sequential quarterly growth when adjusting for seasonal and holiday impacts and one fewer billing.
In the quarter as was noted by Paul.
Precision diagnostics recorded revenue of $96 3 million up eight 2% from the prior year quarter sales a definitive were $67 3 million 10, 9% higher as compared to the prior year quarter technology revenue was $23 3 million up five 3% from the prior year due mainly to.
Mystic sales.
Lastly, strategic partnerships and other revenue was $7 3 million driven primarily by milestone in dose revenue from MK $62 40 within pharma solutions. As a reminder, we sold our rights to the Relistor licensed intangible asset associated with net sales royalties mid year and don't expect to be recording any further revenue with the.
<unk> of any potential future milestone payments.
Gross profit margin for the third quarter was 67, 2% an increase of 100 basis points over the third quarter 2022 on a similar basis as has been the case in recent quarters. The increase is due mainly to favorable volume and product mix led by <unk> infinity, partially offset by the margin headwind of 93.
Basis points attributable to the Relistor royalty asset sale.
Operating expenses were 10 basis points unfavorable from the prior year at 23, 5% of net revenue and $19 $2 million higher on an absolute dollar basis, which is in line with previously guided expense levels.
<unk> investment continues to focus on driving Polaris high branding awareness and adoption alongside ramping efforts to prepare for the launch of PMT to 002 inclusive of market research and overall commercialization readiness G&A expense increases year over year related to our ERP implementation, which.
<unk> on track as well as investments in Ciber compliance enterprise risk management analysis and employee engagement.
Adjusted operating profit for the quarter was 139 5 million an increase of 36, 5% over the same period prior year total.
Total adjustments in the quarter totaled $24 6 million before taxes of this amount 14, and $11 7 million of expense are associated with noncash stock and incentive plans and acquired intangible amortization respectively.
$2.1 million, an increase of 14.6 million over the prior year period.
During the quarter if the company received net proceeds from the roaster royalty asset sale and the amount of $97.8 million, which has been recorded net cash flows from investing activities cash and cash equivalents net of restricted cash now stand at $614.1 million. We continue to have access to our $350 million Undrawn Bang.
Revolver and are very comfortable with our strong liquidity position.
Turning now to our updated guidance for the full year, we are tightening our full year revenue estimate to be in a range of $1.2552127 billion from the prior range of $1.2452127 billion in doing so we are lifting the lower end of our prior clarify revenue range to 842 800.
$60 million from $835 million to $860 million.
As was the case last year.
Excuse me as was the case last quarter, we expect the <unk> to continue its momentum and also expect M. K 62, 40 to contribute 15 to 20 million of revenue rather than the prior guidance of $15 million <unk>.
Turning now to earnings adjusted EPS will be in a range of $5.80 to $5.85 versus the prior range of $5.60 to $5.70 with that let me turn the call back over to Marianne. Thank you Bob our third quarter results were driven by the commercial growth of our market leading products.
We believe I differentiated capabilities commitment to innovation and excellent is there a significant capital resources physician lanthier to remain the leading radiopharmaceutical focused company as we work to find fight and file a disease to deliver better patient outcomes.
That Bob pollen I I'm now ready to take your questions. Operator. Please go ahead.
Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again.
And just a reminder, we need to leave it to questions to one per person.
After asking the question.
Feel free to re enter the queue and police time, while while we compile the Q and a roster.
For your next question. Her first question. It comes from the line of her whenever wisdom Leerink relying on your line is open please answer.
Question.
Great morning, everyone.
So among.
So Monday assumptions going into your new feature total addressable Mark an assumption of over 3 billion. I was curious what are the largest drivers in terms of how many scans would be added to build up to the 600 K scans. I think you mentioned on the call and just how are you considering new piece of my pie competition in there.
Along with your strategies for clarify gross going forward.
Sure happy to take a romantic good morning. Thank you for the question. So yes, we raised.
We have a current addressable market as you noted of about 350000, and that's the estimate of this year, which equates to about $1.6 billion. We've heard you're in and Bachelors feedback. If you think about what the future potential could be and so we've highlighted today the total addressable market, which we would estimate by 2028 to be it.
About 600000 scams.
The Investor presentation. This morning, you'll see the largest driver of growth. There is the expansion of radio log in therapy into earlier lines of treatment effectively from the post chemo setting or third line into second line and first line otherwise known as pre chemo as well as the metastatic hormone sensitive prostate cancer.
A group and therefore that would increase from potential 30000 scans for patient selection and monitoring to approximately 210000 scam. It's a relatively consistent number of scans per patient, but more patients would be eligible for radio wagon therapy, and so that's naturally the largest ah.
Driver of the expectation by 2028 based on our belief of radio like and therapeutic approvals in the coming years, including potentially piano P 2002.
The second biggest driver would be in the recurrence setting and this is really driven by overall incidence and prevalence as men continued to live longer as well as a slight uptick in the number of scans per patient over their lifetime assumptions and then finally, the initial staging for suspected metastases, which is.
Some incidents increases over time, which we expect to be about 2% to 3% per year.
There. There is also an assumption that we see greater penetration into the intermediate favorable population and so that's really where we're looking at all out of 2028 to say this has the potential to have a 3 billion dollar market in that timeframe, which overall makes us incredibly excited about the future of <unk> and <unk>.
Verify in particular, and we believe with our continued commercial and clinical value proposition that we highlighted today and that we continue to promote in the marketplace that we can and will be the market leader for many years to come.
Rowan and many of the comments apologist shared are outlined on slide nine of the deck that we used with this cough and which will be also on our website. If you want to refer back for more of those data points.
Thank you and for your next question. It comes from the line of <unk> from tourists Securities Recharge. Your line is open please ask a question.
Hi, Thanks for taking my questions Congrats on a solid quarter and thanks for the the increased detail on the addressable Tan. So I guess, you Highland and a lot of Expanders, where to go from $1.6 billion to $3 billion.
Over time, but not all of these obviously you're gonna be accessible Paul as you just pointed out overnight.
So I just you know the question I have is we looked at 24, you know is there enough runway with the 1.6 billion 10.
And the initial Tammy Sanders at the front end of that 23 to 28 timeframe to grow clarify next year I think the consensus is looking for high single digit growth not that 940 million just looking to see if.
That a reasonable starting point and can we can we expect.
Growth next year and clarify thanks.
So rich first of all I appreciate the question today, where naturally talking about the third quarter and in due course, we will be talking about 2024, I think were incredibly pleased with <unk> growth launch to date, we grew year over year as I mentioned, it almost 50% what we're able to do the current.
Addressable market is about $1.6 billion uhm, but overall, we still see continued growth potential in both the near and the long term for us to be able to.
To see continued growth and indeed, we do expect to see continued growth of clarified next year and for multiple years to calm, but we haven't put an exact number on that we will naturally provide guidance as we do every year. When we report our fourth quarter earnings and February of next year.
The one point that I would add reaches and you heard in entering around his question you hear Paul say, we still have a very conservative estimate as two number of scans per patient a lot of what <unk>. What we the outline for growth is really just based on new patient populations coming into the pool for consideration, but certainly at physician.
Continue to appreciate the clinical utility of using P. S made pet imaging, especially with Polaris I, we would expect us to see the number of scans per patient grow.
Thank you.
<unk> next question.
And for your next question. It comes from the line of Matt Taylor's from Jeffries match. Your line is open please ask a question.
Hi, Thanks for taking my question your morning.
So can be for for energy I guess, but I did want to touch on point you mentioned the Lily deal is validation.
And I saw on the presentation you were talking about doing some investments in market research and launch readiness. So.
Guess, maybe you could just illustrate for us what you're what you're doing to get ready for it and and he reads that you have from seeing the kovykta data.
Couple weeks ago, and what that could mean for <unk> and your opportunity there.
So rich I'm going to start and then I'm gonna turn it over to Paul because what I'd like to I'll say declare right. Now is that we will follow the same model for piano teaches you you're too that we did with clarify and that is the the testament to how ready we work with that market, how we enter that market, how we reacted or.
Related with all the stakeholders in the market, we really see that as having been very successful in creating a wonderful market model that can be replicated with piano teachers years here too and in some ways it'll be easier because we're at this point now we're already familiar with largely the entire audience certainly with the channel and so we will leverage all those relation.
Shifts as we prepare for that launch before.
Before I turn over to Paul he can make some more comments on our commercial redness I will speak to the pier to me for data in saying that we're we're glad to see data on these types of products being reported now certainly there'll be more data analysis by Novartis and we are eagerly awaiting our own read out.
Of the splash data, which will be fourth quarter 2023, but we think these both these modality show up and I just.
<unk> plasma system, and then all of a couple of follow ups.
Good morning.
Okay.
Can everyone hear me.
Because we believe that there.
Okay. Thank you we believe they're strong therapeutic promise for these products will wait to see the exact data and also of course analyze our own splashed data in fourth quarter 2023, and with that alternative tipoff to finish up comments about our commercial readiness for T. N. T 2002, Thanks, Marianne and thanks for the question, Matt So is highlighted.
Today, we continue to work with point across clinical and regulatory across manufacturing as well as commercial readiness and so we are working closely indeed daily with our colleagues from point to ensure that we are ready for a best in class launch a piano P. 2002 that will naturally include a number of traditional work.
It's understanding the market it's patient mapping it is effectively market research to understand this I would also note that while we're focused on the commercial side of things, bringing a radiopharmaceutical to market is also reliant on a fully integrated supply chain and so understanding and working with our customers to be able to get.
I'm ready to be able to treat with a potentially another lutecium product is also in the mix and so we've got a number of activities. There that have kicked off in 2023, and we would expect to continue into 2024 and beyond.
Alright, thank you.
Next question a customer in the line of Anthony Tony from Mizuho crew. Anthony Your line is open please ask a question.
Hi, Thank you for the question congratulations on the corner, maybe just one on P. N T O two the opportunity very size <unk>, but just wondering if you could provide an outlook on T. N T O two versus the expectations and the market sizing that Novartis has.
Up there.
So again I'm going to turn it over to Paul to offer commentary, but I would point you to slide number nine in the deck that we just released because that does speak to as one of the categories. Those patients who are being Kennedy to radio like in therapy.
Yeah. Thanks for the question Anthony So as we've highlighted recently and I D.
Both Bob and I actually discuss this at a investor confidence September we had previously said that the market potential for P&C 2002 in the U S is approximately three and a half billion dollars that with a number that we put out effectively last year, when we announced the point collaboration what we've seen Sanchez while we.
Not formally updated that number we have highlighted that we think the potential overall for radio log in therapy, and MCR P. C patient could be substantially Baker, what we've seen with <unk> year to date public would say they would be.
Approximately doing $1 billion in sales in.
In their first full year on the market, even with supply challenges, where they were not able to add new patients. Indeed in there I believe their recent earnings call. They noted that they are now actively adding new patients and so for a product in the post chemo setting to do potentially $1 billion in its first of all year on the market without full supply demonstrates that we think there is.
Significant opportunity.
In this not to mention it's only Ineffectively third line or post chemo and so when we expand P. SMA therapeutics to pre as well as post chemo. We think this is a substantial opportunity that ourselves and our partners point are incredibly excited about and we look forward to sharing top line data for the splash try.
<unk> in the fourth quarter of 2023.
That's helpful. In one quick follow up would be just synergies if we assume clarify M. P. T O two.
Is under the same umbrella just.
It'd be a little bit on how go to market would play out it looks to us that.
T N T O two if approved would be.
Sickly synergistic to the existing clarify Salesforce and would you contemplate maybe bundling those two solutions. Thanks again.
So thanks for the question Anthony I think there's naturally benefits of having a franchise that includes a pier semey therapeutic as well as a P. S. M. A diagnostic recognizing that in order to be eligible for appear semey therapeutic you do need to be scanned with appears may diagnostic and so I think we do have certainly I would call. This <unk>.
<unk> advantages because of that.
Robust market position and indeed, we believe that was one of the reasons why it was a natural fit for point in lamp. He has to work together.
Last fall when we announced our collaboration agreement and so there are certainly advantages to having both if you will under one.
One franchise to be able to have conversations with customers that said, we also recognize that there are distinct needs of a therapeutic versus a diagnostic and therefore, we're going to continue to invest to be able to support a therapeutic.
And ensure that we maximize the potential.
<unk> two as well as clarify recognizing there are also comparable Paul points, specifically for urology as well as potentially medical oncology, but we're going to ensure that we invest adequately to support the launch a piano <unk> there are two and the significant market potential that it brings.
Thank you and please stand by for your next question.
Your next question comes from the line of Andy Chef for William Blair. Andy. Your line is open please ask a question.
Oh, great. Thanks for taking my question and congratulations on continued execution.
I want to ask about data coming out of his though and the regulatory dynamics. It seems like Novartis has to wait until 2024 to make a submission decision due to the.
Appearing detriment on overall survival with a has a ratio of 1.16 and.
And when you look at the internal pipeline does that open that door four P. At the 2002 to potentially leapfrog novartis as the first <unk> keep preki most Eddie.
Mmm. So it's it's impossible at this point to estimate what the regulatory filing timelines will be for both products. As we noted I think very repeatedly we are eagerly awaiting the splash day to read out in the fourth quarter of 2023 and that will really form all of our strategy what.
I will say is I think that there is a you know a willing and open attitude at the F. D. A to bring these modality to market and I think that is something that both we and Novartis are also focused on making these treatments available and accessible to.
Patient and we're very confident wear and as I say again, we're looking forward to seeing the splash data. Once we have it will be able to compare it more fully to the P. S me for data and to have that inform our regulatory strategy and what we would see as the regulatory timeline for both these products.
One moment for your next question.
And for your next question comes from the line of Justin was from Jones trading just in your line is open. Please ask a question.
Hi, Thanks for taking my question it might be a little early to get a solid answer on this but I'm wondering if you could help contextualize how you view the size of the potential mid to long term market for an asset like M. K 62 40.
That is really a great question and one that is top of mind for us.
We we look at what's happening in Alzheimer's disease, and the progress of the therapeutic candidates. There and then also the scientific communities I would say analysis and consideration of amyloid versus cow imaging and the what it what it encouraged about patient.
And where they are and they're staging and where they are and they're kind of your clinical timeline and for many reasons of what are really emerging data, we see great potential for Tao imaging agents in their role in helping to not only diagnose, but more importantly stage Alzheimer's patients and while I'm not willing to give a darn.
Figure around that market now I will say that we are we are very very impressed with what the size of that market can be and again, we are not the only company with the towel imaging agent under development or approved but we think that M. K 62 40.
There is some advantages in performance that will be important to the market just as a as a note. There is on an annual basis. There are 6.5 million patients who are diagnosed and it is wonderfully still very highly prevalent population as well. So it's a very large market and we're really thrilled about her.
And the opportunities survey.
One large for your next question.
Okay.
Scott.
Next question. It comes from the line of Blair's solo from CJR Securities. Larry. Your line is open please ask a question.
Oh, great. Thanks, good morning right.
Couple of follow ups. Most of my questions were answered on clarify call you mentioned.
Come from new and existing account.
Actually.
Obviously, a little slower growth too, but just in terms of user mostly at existing account.
Could you just give us an update on sort of where you stand and you've reached there's still a lot of.
Potentially new accounts that you haven't reached yet.
Give us some thoughts around that and also you mentioned came up facility expansion can you give us an update.
Sort of score card there.
Yeah sure. Thanks, Larry I appreciate the question.
So we made a distinction year over year, if we compare the third quarter of 23 of the third quarter of 22 growth was driven by existing accounts as well as new counts and additional pms Activations. If we speak sequentially. The majority the vast majority of growth was driven by existing accounts.
That were over 50, Pms Whereabout 54, Pms currently activated we do continue to activate new Pms, specifically in geographic areas, where additional dose time flexibility is important.
But the the driver has been and continues to be if we look kind of quarter over quarter and it certainly into the future will be the activation of existing accounts, where we already have imaging centers, whether they be free standing or hospital or government facilities that have access to on a regularly offering clarify.
Where in where it is certainly being requested by name the the real work that we've been on for the last year is to continue to activate the referring community that would be urology that would be a medical oncology radiation oncology for them to understand who the target patient is the frequency in which those patients could be scan and we.
Still see significant room for growth in that space the vast majority of accounts.
Have adopted some sort of P. S. Meg pet imaging a market that's annualizing approximately $1.3 billion, meaning that there's not too. Many accounts out there that are not already adopting there may be some small mobile facilities, where either due to geographics or just timing of offering we have to be able to add but I would call that effective.
<unk> <unk> Ah going forward really the growth in this market is going to continue to be the activation of referring physicians insuring that they understand the breadth of our label and a significant potential that P. S may pet imaging can make the clinical practice.
Evident by the change and intended management data, where this is not just the diagnostic this can truly informed patient management and we think that clinical benefit plus our broader commercial benefits will continue to support our growth going forward.
Thank you answer. Your next question comes from the line a few N Z Frumpy O'reilly Q and your line is open please ask a question.
Mmm.
Thank you for working out of our questions and congrats on the call her.
Can you. Please clarify the total cost of a <unk> outrage I mean, the cost of the agents and the procedure in either hospitals tacking or outpatient thank.
Thank you.
As you you want first of all thank you for the question I may ask.
Follow up question to you if you will but the total cost of the procedure is certainly going to vary.
So if you think about the cost of procedure to either a hospital or a free standing imaging center, there's naturally a cost of the tracer.
Would effectively be <unk> for the vast majority of <unk> pet scans and then there are certainly three other commercial agent and two other academic agents available commercially.
Commercially the agents are priced relatively close together and so when we look at what that what that is that's a fairly consistent cost across the market place now.
To estimate the cost of.
The procedure.
There's a fixed cost that's going to be associated with the pet C. T scanner, which is usually an investment in the millions of dollars, but then will last many years.
And then there's naturally the.
The staff associate and otherwise I can't estimate with that is that is a difference for each imaging center and hospital.
But overall Pepsi T has been adopted in this marketplace for decades. It continues to grow and I think we've seen the benefits of <unk> cause a number of institutions to even think about increasing number of pet C. T scanners that they have to be able to better support the patients they serve in the referring physicians that.
Come to that.
So I don't know if that helps answer the question I would just add one that the the the whole market that was built by F. D. G is really what built the pet scanning market, especially young and oncology in the United States market, So as well build out and I think it's it's well the financial aspects of it are well understood. But they are also then.
Burnt by each product because it's Paul noted, while the medical art associated with with offering a pet scan maybe similar across different products. It would be the cost of the trade so that would be different.
Thank you answer your next question comes from the line of David Starkly from JMP Securities. David. Your line is open. Please ask you a question.
Great. Good morning, maybe just a real quick one for Bob.
Thanks for pointing out some of the impacts in the corner, but if we looked at the the seasonal trends the holiday and then the one last Sunday.
Any way you could put like an approximate dollar amount and what you think that that cost you in the corner.
The whale answer that David Uhm is maybe like sort of normalising or adjusting to the sequential growth rate uhm. So if you make the adjustments and we do see this and we pointed out come.
Coming out of the last quarter that we would see increasing sort of impacts from holidays, particularly.
<unk> going to July four in this case and Labor day, and then we will see it again when we get to.
Thanksgiving and then the week between Christmas and new years.
But if we look at the impact of the things that we highlighted we would have expected that is b.
Adjusted growth rate sequentially to be something in the mid single digits.
Which is why we kind of use the language around a consistent quarterly sequential growth rate because if you look at the growth rate from Q1 to cue to an al Q2, Q3, then and then the implied guidance. If you will in queue for they are all very similar kinds of growth rates.
Okay, maybe I'll just add you know I think when we look at the dynamics of the quarter ended I highlighted on the prepared remarks June July and August had relatively consistent volumes on a weekly basis, taking out the holiday weeks, if you will but where we saw growth continue at more.
Sturrock all levels was be August or September on the September to October and we believe that is consistent with what we see across the industry, Indeed definitive which we've been at for 22 plus years, our third quarter is always our weakest quarter and is even down sequentially.
And where you look at other procedural based reporting organizations July and August are relatively slow now in the past couple of years, we may not have been able to see that in our financials may not have depicted that as much because the growth trajectory of clarify at 100 per cent plus growth activating new pms, adding new accounts that doesn't necessarily stick out.
But if you look at last year as an example are sequential growth Q2 to Q3 was also the lowest sequential growth of the year and so that's consistent with what Bob just highlighted.
Thank you and we have a follow up question from Rwanda Ruiz from Leerink. Please go ahead.
Hi, Yeah, just a quick one from me I'm not sure I heard on the call, but have you mentioned the current market share for clarifying the quarter uhm relative to last quarter I think last corners around 70 per cent penetrated.
Thanks were on it we we had not mentioned that we have not gotten the question. You know overall I think clarify remains the clear market leader Ah number one P S and a pet imaging agent with over 250000 scans since launch we believe our share was relatively consistent in the quarter at approximately 70 per cent.
I do use the term approximate recognizer then only two of the four commercial players actually report.
P S may pet revenues.
But overall, we know we know added competition in the quarter, we believe that impact was relatively minimal and so are comfortable that our continued.
Commercial and clinical value proposition as well as the significant growth potential is highlighted by the $3 billion plus potential by 2028 will continue to insure that clarify continues to grow and also remains the clear market leader for many years to come.
Is there a follow up question from rich.
Oh, Hi can you hear me.
We can now Oh, sorry.
So thank you for taking the follow up here.
Thanks for those seasonality comments on clarified helpful. I'm just I'm just curious Bob I think you had mentioned that you still have some selling you know de issues you know holidays between three and four Q, but your your updated clarify guidance actually.
Assumes.
You show Ah Ah Ah Ah, 6% or close to it at the mid point quarter over quarter growth rate.
I'm just curious is that just fork you pick.
Pick up which more than offsets maybe the holiday impact, which it didn't have because of a week July August or weaker softer July August in three to what what drives the reacceleration.
Sure.
So.
Paul you can jump in on this as well, but you know one we've been really pleased with the recent trends that we've seen from a from a dose volume perspective, which I think is fairly consistent when you look across broader.
In a broader health care <unk> once you get into that post summer seasonality that you do see a pick up once again as patients returned to the docks and the docks return also too back to work after a summer so that range does not include.
You know, we're not addressing if you will for those holidays and you can see you know I think we provided a visibility to what those those holiday periods look like Uhm again, what we've seen more recently is informing our guidance range.
And and of course from a selling day perspective, Q4, and Q3 are similar.
So then so that we would only be the holiday impact.
I don't have a lot more to add I think we've seen robust growth we saw it coming out of the summer and the postmark holiday period as I highlighted we've seen that continued into October as people are back to the doctor's offices doctors are finished and and text and others are finished the traditional summer Holly.
At a period and so our guidance takes that into account as well as in November and Christmas week impact that we've seen in our well understood in the industry.
I will just add and I'll continue to remind people we are still very much a wonderfully in a lunch here and we are getting to know the market.
<unk> both referred to we know appreciate that similar to this entity in similar to what a lot of otherwise scientists company say third quarter has some obstacle vacation ality and it it does in past total number of procedures that then rebound in Q4 and just to be clear on the math with what Bob was saying is versus.
Two Q3 had won the less selling day, but we see the number of of available selling days in Q3 equal to that of Q4, so there'll be no impact based on number of selling days 424.
Alright, so per sensors, and ladies and gentlemen, there are no further questions at this time and thank you for participating in today's conference. This concludes the program.
And have a wonderful day.
Thanks.
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