Q2 2023 Theravance Biopharma Inc Earnings Call
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Ladies and gentlemen, good afternoon, I'd like to welcome everyone to their road bans Biopharma second quarter 2023 conference call. During the presentation. All participants will be in a listen only mode. A question and answer session will follow the company's formal remarks to ask a question simply press star one one on your telephone.
Again, that's star one wanted to ask a question if you'd like to remove yourself from the queue simply press star one again.
And if you're listening via webcast. Please mute the audio on your webcast device before asking a question over the phone.
Will repeat these instructions after management completes their prepared remarks also today's conference call is being recorded and now I'd like to turn the call over to Rick Winningham, Chief Executive Officer. Please go ahead Sir.
Good afternoon, and thank you for joining the <unk> Biopharma second quarter 2023 conference call.
On slide two I'd remind you that this call will contain forward looking statements that involve risks and uncertainties, including statements about our development pipeline expected benefits of our products anticipated timing of clinical trials regulatory filings and expected financial results information can.
Certain factors that could cause results to differ materially from our forward looking statements is described further in our filings with the SEC.
Turning your attention to slide three I'm joined today by Rhonda <unk>, Chief business Officer, Rick Gram head of research and development as a swath Chief financial Officer.
Beginning today's presentation with slide four.
We set out earlier this year with three clear strategic objectives in mind to continue to grow your perl rate by executing on our in our hospital strategy, while closely collaborating with via trusts.
Launch and build momentum behind our phase III Cypress study, an MSA patients with neurogenic orthostatic hypotension.
And to deliver on our capital return commitment, while managing our expense base.
Through the first six months of the year, we've made good progress and remain on track to accomplish these objectives.
As we move into the second half of the year. We're prepared also preparing for an exciting new chapter in Terabits as evolution in the coming months, we expect to learn the results of our phase four peffer to study for you Pal rate to begin early regulatory and commercial planning for <unk> and attain non-GAAP .
Profitability subject to you Pal <unk> continued growth.
Moving to slide five I'd like to highlight our 2023 progress today.
During the quarter, our commercial team work closely with our <unk> partners.
Post solid results for you Pal rate with the brand achieving record performance on a number of key metrics.
Net sales increased 12%, while delivering strong retail demand growth and achieving new highs in market share with the long acting nebulous Asian segments.
We continue to drive <unk> calorie brand awareness for the maintenance treatment of COPD, including its concomitant use with long acting beta agonist therapy and its adoption amongst patients who have difficulty with an ELD devices.
Part of this latter population is the subject of our peffer to study the results of which we expect to communicate early next year in.
In addition to having received orphan drug designation for <unk> team in May we made significant progress with Cypress opening sites in the U S and working with our outside the U S regulators to achieve key milestones towards meeting our enrollment objectives. Our teams also submitted abstracts for.
Patient at medical meetings scheduled for the second half of this year.
These are a potential of importance in helping establish ample oxyt teams' differentiated clinical profile as we approach cypress's conclusion and potential commercialization.
Third we made good progress on both our capital returns program and on our goal of reaching non-GAAP profitability as of June 30, <unk> returned nearly 264 million through this program.
The company remains debt free and stands to benefit financially from important milestones and royalties derived from assets and territories for which the Companys partners carry commercial responsibility and.
In summary, our team is working hard and executing well against the priorities we laid out for the year. We remain enthusiastic about the potential catalysts, we have before us as always we approach these challenges and opportunities with a core mission of delivering medicines, which truly make a difference thereby maximized.
The organization's long term value on behalf of our shareholders.
At this point I'd like to turn the call over to Rhonda to cover your <unk> performance and significant opportunity that we see to continue its growth for the foreseeable future Rhonda.
Thanks, Rick.
Moving to slide seven we are pleased to share the latest performance for your salary.
During the quarter total net sales of <unk> reached 55 million up 12% year over year.
There are answers imply 35% share of net sales for <unk> during the first quarter of 2023 with $19 3 million.
As a reminder, serve anthem Beatrice co promote <unk> in the U S with <unk> commercial and medical teams covering the hospital segment and the interest being responsible for outpatient based community health care needs and promotion for the product.
With a return to net sales growth in Q2, we remain confident that our team will deliver strong performance for the year based on a number of positive key performance indicators to this end retail patient demand continues to reach new highs.
As Rick mentioned in his opening comments, we have formulated and are executing a winning strategy for driving <unk> growth in the hospital setting.
We focus our efforts on a number of areas, including formulary wins clinical pathways and discharge planning protocol.
The goal of making <unk> available to PD patients, who may benefit from the only long acting Nebulize llama.
Looking at their answers hospital results on the right side of slide seven.
Q2 doses sold exclusively in the hospital setting represented a slight 2% decrease from the previous quarter, but increased 45% compared to the same period a year ago.
Turning to slide eight <unk> share of the long acting nebulize market in the hospital setting reached an all time high of 15, 2% in Q2 of 2023.
We believe a number of new account wins and forthcoming system formulary additions will yield continued growth through 2023 as you power. It will be the first woman of choice in many hospital due to the growing recognition and acceptance of <unk> clinical benefits and once daily value proposition.
As a key component of the joint strategy between the Bureau van can be interesting data continue to show that the large majority of patients receiving <unk> in the hospital setting are discharged with a prescription to continue their treatment in the outpatient setting, allowing for continuity of repowering maintenance therapy post hospitalization.
Reflecting further on the community setting, which includes both the retail and DMA channel <unk> market share increased to 29%.
Through may of 2023 based on our latest available data.
On slide nine we provide a snapshot as you tolerate retail script performance, which serves as a reliable proxy and a more real time view of community demands.
With total prescriptions and new patient starts continue to reach new quarterly highs during the second quarter.
Hello scripts increased seven 8% quarter over quarter, and 25, 9% year over year, while new patient starts increased five 6% quarter over quarter and 53% year over year.
New patient starts are key to future performance and the recent exceptional growth in both new patient starts and total prescriptions can be attributed to the realization of new commercial initiatives, which include concomitant use education.
<unk> into additional site of care channel and continued focus on fulfillment support.
Looking beyond this quarter success, there still exists significant long term growth opportunities for <unk>.
On slide 10, starting with the current long acting <unk> patient population in the upper left corner.
We expect our market share to continue to grow.
Switches as well as an add on therapy with further deployment of concomitant use education.
As we have previously noted.
Dated 2023 gold guidelines now recommend initial combo Lama LABA therapy for both groups B and E. Yet a substantial number of patients in these groups remain symptomatic on nebulizer, labat mono therapy and could receive additional benefit from adding new pelerine.
There are also many patients in appropriately using short acting nebulize treatments for maintenance you may benefit from switching to a once a day long acting therapy, such as <unk>.
These are patients who are obviously familiar with nebulizer therapy and have a reason to be using the nebulizer, but choose to rely on short acting therapies, which typically require four to six administrations daily versus transitioning to a once a day maintenance therapy.
Lastly, there are even more patients on handheld only maintenance regimens that remain symptomatic due to a number of reasons, including dexterity challenges cognitive impairment and are suboptimal peak <unk>.
We believe that this population could benefit by switching to Nebulize therapy involving <unk> is the only once daily Nebulizer Lama indicated for COPD Nathan maintenance treatment.
In particular, we are looking forward to learning the results of the <unk> study, which compares you can tolerate directly to Tia trophaeum administered via a dry powder handheld device in patients with suboptimal peak <unk> trial.
As many of you know via Tropaeum is one of the most prescribed lama therapies for COPD.
Yeah.
At present, we estimate that approximately 60000 patients are receiving you tolerate therapy, representing only a small fraction of the sizable niche opportunity these patient segments represent.
In aggregate, we size the addressable patient population and approximately 2 million potential patients for whom <unk> may be appropriate, suggesting we've only started to scratch the surface.
Given the significant remaining opportunity, we expect to be able to continue.
Not accelerate the pace of <unk> adoption moving forward.
With that I will turn the presentation over to Rick Graham Rick.
Thanks Rhonda.
As we've covered in the past slide 12 illustrates the design of the ongoing phase <unk> study in patients with severe or very severe COPD and suboptimal peak inventory flow rates.
Patients are randomized one to one to receive either <unk> utilization or Tia tropaeum delivered via dry powder inhaler and the primary endpoint is changed from baseline and trough, maybe one at day 85.
Enrollment is nearly complete and we expect to have top line results late in the fourth quarter of the year will.
We're continuing to work with our partners that would be interest regarding the exact timing of disclosure, but currently intend to disclose results in January of 2024.
On slide 13, I'd like to remind our audience briefly of the rationale behind the paper to study design.
Our previously conducted Pepper one study published in 2019.
Thanks.
Included 206 patients two three and four status.
And our peak inventory flow of less than 60 liters per minute.
Gold two three or four patients have moderate to severe moderate to very severe COPD and baseline F&B one of less than 80% of what would be predicted.
In paper one Rev. Venison treatment did not demonstrate a statistically significant advantage over Tia tropaeum.
Though there was a numerical trend favoring road with venison driven by gold three and four patients with baseline F&B one of less than 50% of predicted.
Importantly, our pre specified analysis of gold three and four patients shown on the right hand figure demonstrated a clear and clinically relevant treatment benefit of <unk> over <unk>.
We therefore designed the pepper to study in this population of responders.
Patients with suboptimal peak inspiratory flow and baseline <unk> values of less than 50% of predicted.
As Rhonda covered in our comments a positive result from pepper too will provide the commercial organization a catalyst to help drive <unk> calorie update and a portion of the maintenance COPD market, whose symptoms are inadequately controlled despite treatment with handheld lama containing regimens.
Turning to ample OXXO team slide 15 outlines the design of a Registrational study 197 also known as Cyprus.
The treatment of symptomatic moh and MSA patients.
On the strength of the prior phase III study results and alignment with the FDA on the primary endpoint and study designs. We believe the Cypress study has a high probability of technical and regulatory success.
The study consists of a 12 week open label period, followed by an eight week double blind placebo controlled randomized withdrawal phase.
The duration of the open label and randomized withdrawal periods were optimized based on the results from our prior $1 70 study.
Given the strong results from the 170 study the primary efficacy endpoint in Cyprus is the change in Ohn's a composite score.
The composite score captures a broad set of symptoms and is expected to reduce variability relative to an individual's symptom scores such as IHS a number one an endpoint that has been used in other programs.
As announced last quarter the phase III Cypress study is open and actively recruiting patients and we project enrollment to be completed in the second half of 2024.
I'm proud of the team's accomplishments as they've made good progress in activating multiple clinical trial sites in the U S with several more coming online in the near future.
We have also made substantial progress with the new centralized EU clinical trial application process and expect to be in a position to activate a large number of EU sites throughout the second half of this year.
As shown on slide 16, we estimate that the addressable patient population for <unk> is between 35% and 45000 individuals in the United States.
Despite two approved therapies indicated to treat symptoms of orthostatic hypotension, there remains a significant unmet need which we believe <unk> could address.
First based on data generated to date, we believe <unk> has the potential to impact multiple symptoms of NIH durably with a favorable safety profile.
Either approved or wage therapy has demonstrated broad and durable symptom relief and patients with NIH, including those with MSA.
Second ample OXXO team is dosed as a single 10 milligram tablet administered once daily.
Is especially beneficial for MSA patients with Dysphasia, which is a frequent and disabling symptom of the disease current therapies typically require patients to take multiple tablet several times a day.
Third patient with NIH are also at risk for Supine hypertension, a dangerous Inc increase in blood pressure, while lying down.
The two FDA approved therapies that are used for the treatment of orthostatic hypotension have black box warnings in the label highlighting the risk and recommending both frequent monitoring and management thereof.
Relative to the current treatment options ample oxiclean has the potential to decrease the risk of supine hypertension.
At night ample Occitane remains in the system, resulting from its relatively long half life, but because the natural norepinephrine levels are reduced during sleep <unk> team does not cause overstimulation and as a result reduces the risk of hypertension.
In fact in our safety database of more than 800 patients in healthy subjects no signal for supine hypertension has been observed with ample oxygen treatment.
As we enter a new era in trading MSA symptoms. We believe <unk> offers hope to MSA patients with symptomatic Noh H.
On slide 17, we summarize how the current treatment landscape translates into opportunity for Amdocs team.
Owing in part to only two therapy is being FDA approved coupled with their limited effectiveness as well as safety and tolerability issues treatment tends to be highly individualized and NIH.
Issues, such as inconsistent response to therapy, and the risk of supine hypertension, complicate medical management and lead to high administrative burden burden.
Depending on their experiences patients may remain on therapy for only a short duration.
Based on our clinical experience with ample oxygen to date, we believe that it offers significant potential to improve both the number of symptomatic MSA patients treated with pharmacotherapy for NIH and both compliance and persistence rates amongst those treated.
<unk> appears to be safe and well tolerated and given its differentiated efficacy and safety profile. We are optimistic that it will yield clinically relevant and durable benefit for patients I'll now turn the call over to the east to review the financials.
Thanks, Rick on slides 19, and 20, you can find our financial results for the quarter, which came in in line with our expectations.
Shipping ahead to the highlights on slide 21, our collaboration revenue recognized through our Beatrice partnership grew 26% in the quarter to $13 $7 million.
As a reminder, while this figure incorporates 35% of <unk> net sales as recorded by via trips it may fluctuate from quarter to quarter due to the shared expenses <unk> reimburse each other under the terms of our collaboration.
During the quarter, our operating expenses, excluding stock based comp and nonrecurring items were approximately $22 million down from $27 million in Q1, 2023 landing us in line with internal expectations and on track to meet our 2023 guidance.
Stock based comp, excluding restructuring expenses declined 21% year over year and including restructuring expenses.
Were incurred in 2022 and not in 2023, our stock based comp declined 35% year over year.
One item to call out, though is not in our previous guidance of $1 2 million nonrecurring charge related to the sale of lab equipment in the quarter.
While generating an accounting loss the sale actually brought in approximately one 5 million of net cash proceeds.
As mentioned on previous calls, we do not anticipate incurring any additional cash related restructuring cost in the future.
Our non-GAAP loss in the quarter was $7 4 million and excluding the aforementioned noncash nonrecurring accounting charge, our non-GAAP loss would have been $6 2 million.
We ended Q2 with $167 million of cash and equivalents no debt and 30.
$53 7 million shares outstanding, reflecting a 30% reduction in share count year over year due to the continued progress of our share buyback program.
Looking ahead, we are maintaining our operating expense guidance for the year, excluding share based comp and onetime items. As we have previously mentioned R&D expense should be steady in the third quarter before beginning to build into year end.
We expect SG&A SG&A to slightly decline in Q3, and Q4 and remained relatively steady throughout the remainder of the year.
As Rick mentioned earlier, we continue to expect to generate non-GAAP profitability in the second half of the year, which will be primarily driven by the expectation of increased net sales growth from new tolerance.
Turning to slide 23 for a brief update on our capital return program, we bought back over $80 million worth of shares in the quarter.
Giving us with $61 million left on our authorization and bringing the total capital return since inception to $264 million.
We continue to expect to complete the program by year end.
Finally on slide 24, I'd remind everyone of our potential to earn milestones and royalties on global net sales of trilogy realized by GSK.
Beginning this year and extending through 2026, we have the potential to earn up to $250 million and sales milestone depending on <unk> performance in.
In the second quarter, <unk> sales reached $760 million up 29% and year to date sales reached approximately $1 3 billion up 27%.
While it is still unclear, whether we will achieve the first of the milestones in 2023, we are increasingly optimistic based on trilogy has continued strong growth that we should achieve at least some of the sales milestones between now and 2026 available to us through our arrangement with royalty pharma.
With that I'll turn the call back to Rick for closing remarks, Rick.
Thanks disease.
I'm happy to share that the second quarter of 2023 represented a strong example of how their events is focused strategy positions the company and its shareholders to benefit from balanced value creation.
<unk> enjoyed good growth this quarter, owing to solid execution by our commercial partnership and continued messaging around concomitant use with nebulize losses on.
On top of this we also see a substantial opportunity to replace inappropriate use of short acting therapies as maintenance and handheld devices were nebulizer therapy may offer clinical advantages, we continue to work hard to advance the Cypress study.
Might make this important therapy available.
More broadly and we look forward to sharing further details on the program in the coming months.
Finally, it is heartening to see trilogy growing so strongly with several important financial milestones right around the corner.
We're delivering all of this from a position of solid from a solid financial position and having returned over $260 million of cash to our shareholders through our capital returns program, while reducing our ongoing expense base significantly we.
We appreciate both your interest and support as we continue on <unk> new growth trajectory. Thank you all for joining us today and I'll now hand, the call back to the operator for questions.
Certainly as a reminder, if you have a question at this time simply press star one on your telephone one moment for our first question.
And our first question comes from the line of David Risinger from Leerink. Your question. Please.
Yes, thanks, very much and thank you for the update so.
I have a few questions. Please first with respect to.
The revenue.
Revenue prospects for the business.
Could you talk about how we should think about.
Year over year revenue growth potential in coming quarters.
Relative to the rate of growth that you booked in revenue in the second quarter.
And then second.
With respect to the.
SG&A spending.
That was $30 million in the first half of 'twenty three excluding stock based comp.
The guidance is for 45 to 55 for the year, so at the midpoint of that guidance at $50 million.
That would reflect.
A meaningful step down in SG&A spending in the second half versus that $30 million in the first half.
If you could comment on that and help us think about.
How we should think about prospects for SG&A spending.
Both in the third quarter and the fourth quarter I E is one going to be higher than another for some reason.
You very much.
Disease.
You want to take the revenue and then bridge over to SG&A.
Yes sure.
I can comment on the on the collaboration revenue and the net sales.
David as we've talked about before.
I think there's a gap between the 35% of the net sales in our collaboration revenue has been around five or 6 million Bucks and thats been consistent over the past year or so.
That gap will probably remain pretty consistent going forward into the outer years, So the way in which you had modeled.
<unk> revenue going forward is just whatever incremental dollar of net sales 35% of that gets added to the collaboration revenue and.
In other words that gap the gap between the 35% in the collaboration revenue should remain steady. So if you want to model in next year, just take the incremental sales amount times by 35% and added to the collaboration revenue and that will get you your model out to next year and beyond for collaboration revenue.
Now we're still in the process of going through the budget with Beatrice.
Third budget that does affect that gap between the 35% of the sales and the collaboration revenue, but I don't expect to be a meaningful change to the underlying shared expenses related.
Related to the collaboration so that's question one and the second question is a good question about the SG&A.
As I mentioned during the call I do expect SG&A spend to go down in Q3 and Q4.
For overall spend we are very much in line with our with our guidance its kind of $90 million at the midpoint, we're trending a little bit lighter on the R&D side and little bit higher on the SG&A side.
Part of that.
Our SG&A relates to this an allocation issue between R&D and SG&A. After the research restructuring in Q1 as a proportion of the overall company R&D is smaller and therefore just gets allocated.
Lesser amounts of the kind of overhead costs.
Which gets shifted over to SG&A becomes it because it becomes a greater proportion of the overall overall company, even though the actual overhead costs don't change at all so just kind of some shifting of dollars between R&D and SG&A artificially as a result of the research restructuring.
So thats one cup one reason, but if you think about the SG&A in Q3, and Q4 should be pretty.
Pretty similar in Q in Q3 in Q4, it's going to go down from Q2.
But again the Big picture is we're right in line for total expense perspective related to guidance, we're slightly below for R&D and slightly above.
But all within the ranges that we provided before so hopefully that provides a bit of color for you David.
Great. Thanks, David.
Yes to add just a bit a bit more on.
Drivers of sales growth in <unk>.
Rhonda.
<unk> talked about this during her section if you really look at.
The sales right now <unk> long acting beta agonist, which which are generic.
Current gold guidelines and then the fact that nearer.
Nearly 50% of our phase III program had concomitant use of either a beta agonists for beta agonist plus of inhaled corticosteroid.
The use of <unk>.
With the nebulizer long acting beta agonist.
<unk> patients.
Patients.
Hearing to gold guidelines from physicians adhering to gold guidelines can serve as a significant driver of revenue growth for us going forward with <unk> in that setting aside.
The opportunity Rhonda spoke about with with short acting <unk>.
<unk> medical medications that are currently on appropriately being used as maintenance therapy, and then any lift that we can get from the <unk> study should be positive.
Got it thank you Rick.
Yes.
Okay.
Next question operator, yes, sorry. Our next question comes from line of Douglas Tsao from H C. Wainwright Your question. Please.
Hi, Good afternoon. Thanks for taking my question is just maybe starting with <unk>.
As a follow up to the last one in terms of how we should think about.
Your share of the collaboration revenue.
Revenue.
Versus your sort of the implied revenue share I think you said that it's been about $5 million to $6 million had a quarterly basis should we think about in terms of absolute dollars or does there come a point, where we should just think about it as a certain percent.
Change in and over time should that sort of narrow as we get increased profitability in that business to Scott.
Through economies of scale.
Leverage in the business.
Yeah. Thanks, Doug.
So I would as I mentioned to David a second ago.
It is from an absolute basis, so that five or $6 million should stay consistent in other words, if you tolerate sales go up a $100 million.
Making up an extreme example.
The gap between 35% of the sales.
<unk>.
The collaboration revenue will still be $5 million now the percentage from a relative basis, it will be very minor, but the not the nominal absolute number will still be 5%.
So when when you calibrate starts to grow more materially in the future. This gap will be less relevant right it'll it'll be from a percentage standpoint relative standpoint be somewhat on meaningful.
Does that help Doug, yes that does and can you provide just a comment in terms of how you're telling me is doing from a gross to net standpoint right now.
Yes, Ron I think yes go ahead.
Yes, so we can't and I'll pass it on to run it for additional commentary here.
We don't comment on gross to net that's something that via trust managers.
But I think in terms of ASP I think it's safe to say that <unk> is a nice Jeff has done a nice job keeping asps relatively stable over time, and we have not seen any material changes to the gross to net over.
Typical things small things here and there, but overall the gross to net has been pretty steady quarter over quarter and we've been pretty we've been very happy with the way in which <unk> has managed ASP.
So Brian do you have any additional comments there.
Well said Asps is very healthy for this product.
And then just one more final question.
Now that the <unk> readout is is really.
Sort of getting close how should we think.
If we get the outcome that we expect to get how should we think about that or how what's the sort of.
Roadmap for getting the full benefit of that commercially.
Sure.
Robert you want to take that yes, I will start with the obvious that you've already stated does and that being a positive study and then ensuring that we get that publication and peer review very quickly, which would be the plan and then having the ability.
80 to communicate these data more broadly.
With our partner with the.
The optimized outcome, which would transpire over the course of the subsequent quarters for 2021.
Would there be if you.
Look at.
Go ahead.
As you can say Rick is there any thought to trying to get that added to the label formally.
Well I think.
We have a.
Our label is very broad.
<unk>, it's the maintenance treatment of COPD.
There are as you can see if you could see from the publications that we've had historically.
A lot of care for patients with him in the label today.
What we've done here is just narrow down on a segment of care for patients based all of this as Rick outlined F&B, one predictor in a particular gold stage.
Gold three and four.
Where we might be able to further highlight the benefit.
Versus handheld product.
<unk>, so I think the.
It really can be positive data here can be quite meaningful to us without putting it in labor will get when we have such a broad label right now.
And that.
We're talking about showing in a fairly.
Fairly sizable patient population of COPD patients that the medicine.
Outperform.
The largest.
Product in the category, which is T a tropaeum.
Okay, Great that's really helpful.
Thank you and as a reminder, ladies and gentlemen, if you do have a question at this time. Please press star one on your telephone.
And one moment for our next question.
And our next question comes from the line of Vivat Privitera from Cowen Your question. Please.
Hi, congrats on the quarter and thanks for taking our questions.
<unk> can you talk about the slight decrease of 2% this quarter and the hospital doses despite the share increasing.
Maybe discuss this decline in the hospital market and what was the reason for that.
Sure.
I appreciate the question.
I think just to still kind of level set that that slight decline, we're coming off of the largest significant large quarter.
In Q1, and also trying to reconcile that relative to seeing that continued market share.
And some decline overall in the long FTE Nab.
Just a bit of a small blip in thinking about the impact of short acting nebulize shortages that.
Basically informed some some buying patterns within the hospital segment. However that drawdown has already occurred and looking at the current trends already in Q3, we've already exceeded that gap. So I think I would kind of classify that as a small dip and then.
Take that a consideration relative to all of the other kpis continue to increase we have a significant proportion of patients that are leading the hospital with a post discharge script for <unk>. Thank you about that translating to the outpatient persistency as well as the.
Increases in the retail view with both total prescriptions as well as the new patient start seeing those significant growth factors contributing to the larger kind of transition of care.
Thanks, Rhonda that's very helpful. So, yes, so in short yes in short EBIT.
Our view is that Q2 was really was really a blip in terms of the market.
As Ron said were the market's already back on track here in Q3.
Perfect. Thank you and for the peffer to trial.
Can you level set about what we can expect from the topline disclosure.
Which secondary endpoints youre going to be disclosed how much safety and.
In terms of the secondary endpoints, which ones do you think are particularly important to drive adoption.
So I'll start with that and then I'll hand, it over to Rick I think relative to the disclosure and what you know.
What a relief might look like.
Still working through that obviously with the with our partner.
Being able to show a difference clinically meaningful difference.
Paul in the F&B, one along the range that we saw earlier gold three gold for patients that Rick highlighted that would be quite substantial.
Yes.
We can talk about the other secondaries, but we're still working through talking about secondaries were still working through what the what the disclosure would be in our release Rick.
Yes, not much more to add but if I think.
As Rick said the primary end point change from baseline in trough F&B wanted to 85.
The key secondary endpoint trough overall treatment effect on F&B, one I think that's probably reasonable to include and then key focus on the key safety events and then as we usually do after topline will present the follow up data.
Some format, perhaps an upcoming medical meeting.
Perfect. Thank you so much.
Thank you.
This concludes the question and answer session of today's program I'd like to hand, the program back to Rick Winningham for any further remarks.
Yes, I'd just like to thank you for joining us today.
For discussion on the second quarter results, we look forward to.
Keeping you updated through the remainder of the year and we're very excited about 2023 and what it what it means for the company and what it means for our execution.
And driving our mission to medicines that make a difference for patients and driving long term shareholder value. So with that thank you very much and have a good day.
Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
Goodbye.
Okay.
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Okay.
Okay.
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