Q2 2020 Akcea Therapeutics Inc Earnings Call

Good afternoon, and welcome to the Akcea Therapeutics incorporated second quarter 2020 Conference call. As a reminder, this call is being recorded I would now like to turn the conference over to Angelo actually its vice President of corporate Communications and Investor Relations Mrtwo. Please begin.

Thank you Chuck.

Hello, everyone. Thank you for joining today's call with me today, our Damian Mcdevitt, our Chief Executive Officer.

Okay, our chief commercial officer, and Michael price, our Chief Financial Officer.

As a reminder, this conference call includes forward looking statements regarding the financial outlook for Akcea, Axios business, and the therapeutic and commercial potential abaxis products in development.

Any statements, describing axiom goals expectations financial or projections intentions or beliefs, including the commercial potential of Tech city, we lived <unk> and ex U.S other medicines and development is a forward looking statements when should we consider that risk.

Such statements are subject to certain risks and uncertainty.

Typically goes in here into the process of discovering developing and commercializing medicines that are safe and effective for use with human therapeutics and India endeavor of building a business around such medicines.

I see as forward looking statements also involve assumptions that if they never materialized or prove correct could cause its results to differ materially from those expressed or implied by such forward looking statements. Although actually goes forward looking statements reflect the good faith judgment. If its management. These statements are based on me all the facts and.

Factors currently known by Akcea in particular, we caution you that are forward looking statements are subject to the ongoing and developing circumstances related to the Coca 19th pandemic, which may have a material adverse effects on our business operations and future financial results.

As a result, you are cautioned not to rely on these forward looking statements. These and other risks concerning axioms programs are described in additional detail NXT. His most recent quarterly report on form 10-Q asked in the most recent annual report on form 10-K on file with the FCC.

Copies of these and other documents are available from the company inhibition earlier today, we issued a press release and related financial tables, including a reconciliation of GAAP to our reported non-GAAP financial measures.

I'll discuss today to read this press release on to access the slides that accompany today's call. Please visit the investor section of our web sites now I'll turn the call over convenience.

Thank you as Lynn good afternoon, everyone and thank you for drilling stays cool.

We performed well in the second quarter, you continued to grow revenue for both tech savvy and way Liberal we advanced our robust pipeline of transformational medicines and we added 40 years of cheap despite the challenging cope with my team environments.

We ended Q2 with $319 million in cash and short term investments on the balance sheet.

Giving us the financial flexibility to execute on our shores and longer term strategic priorities.

We are a commercial stage biopharmaceutical company that has committed to developing and commercializing transformational life changing medicines to treat patients with serious and rare diseases.

In just five years, we're proud to have already launched two commercial medicines kick study and way there.

Built a strong cash position I'm builds an exciting late stage differentiate the pipeline antisense all the good you excited medicines covering multiple well validated targets.

This allows us to capitalize on our strengths and supporting patients. We're currently under served as well as health care professionals and caregivers in treating serious and rare diseases.

We are advancing six medicine from the groundbreaking ioannis, if so platform and are pleased with the progress take study and we never Oh, there already launched commercially.

And our for next generation like investment in the pipeline Akcea teach youre lrx and I see a blue whale Rex healthy gum phase three studies Akcea April see three Rx is moving into phase three I'm, hoping olson is moving into phase to be.

The consistent performance across the like a program in terms of efficacy safety and Tolerability further validates the advantages of the platform.

During the time then they are patients have been able to stay on therapy and quickly access. Our medicines are approved antisense medicines are subcutaneous self injection into our patients can choose to take the therapy at home.

It is one of the important benefits uptick study and my Liberal along with are demonstrating to see a manageable well understood safety profiles.

In the second quarter, we continued to see revenue growth with both tech savvy and weight over total product revenue was $16 million, an increase of 66% from the second quarter 2019, and an increase of 8% from the first quarter Twentytwenty.

We're making excellent progress in expanding into new countries for both medicines.

Kick study first launched in the third quarter 2018, and there's no commercially available in 15 countries.

We never out after launching the third quarter 2019 is no commercially available in four countries.

We expect these new countries to fuel revenue growth going forward.

Oh, we'll talk more about the progress, we're making with tech savvy and where your breath later on the coal.

During the quarter, we and I am I was announced the publication of long term clinical data for tech savvy in patients with Paul you're off the driven by hereditary trends I recently, one doses.

Results from the ongoing open label extension study of the pivotal neuro TTR trial harvest in the European Journal Neurology show the patients treated with takes they experienced sustained improvements and measures on your patent progression at 39 months of therapy compared to the natural history of the disease.

Patients were administered who are where Mr. Tech savvy also experienced clinically relevant improvements measures the quality of life compared to the natural history of the disease and no new safety signals were identified.

This further establishes a favorable risk benefit profile seen in Haiti agency or patients treated with tech savvy for their polyneuropathy.

These data also demonstrate how important it is for patients with this debilitating disease have access to a treatment that can deliver long term clinical benefits.

It's taking over as CEO last September I have made as a priority to enhance and build upon the strength of our management team.

In the second quarter, we added several new members the team I'm extremely happy to report that's a new senior leadership team is now fully in place.

We added Michael price as executive Vice President and Chief Financial Officer, who you will hear from later on the coal.

We also added Carl tools, and a senior Vice President and Chief Human Resources Officer.

Dr Kid much of Sherri senior Vice President of isn't a corporate strategy.

Tracy Palmer Burns as Chief compliance Officer, and most recently Dr. Christophe Liederman's Senior Vice President of Global Medical Affairs, Dr., William Andrews as Chief Medical Officer.

Dr. Andrews is taking over from Dr. Livio D, who recently retired and who will continue to serve as an advisor to the company to ensure a smooth transition.

We're excited to have the full team in place I look forward to their many contributions as we know the company board and execute on a rare diseases strategy.

For this year with our commercial medicines, we're anticipating a number of upcoming events, including additional weight different tech savvy country launches throughout the year.

Now turning to weigh liver in the U.S.

We haven't encouraging meeting with the FDA This spring.

Based on feedback from the meeting we're preparing the Resubmission, which will include real world data, while we do not need to conduct and you clinical study we need to complete some administrative steps to access data that supports our refiling.

We will keep you posted on the timing of this we finally.

Now moving to the pipeline.

We're all scheduled to begin the phase three study in SCS. This year for Akcea April Sicree Lrx.

For FOUP, an orphan the program has it back towards the phase to be dose ranging study that will be led by Pfizer.

And then the subsequent phase three Pfizer that program is planned to include studies to support an indication for severe hypertriglyceridemia as well as a cardiovascular outcome trial to support a cardiovascular risk reduction indication.

We will be presenting the late breaking clinical trial abstracts for both the group Norcen and Akcea April C. Lrx at a medical Congress this quarter.

With Akcea April eight Lrx also known as teaching Jay to 30. The outcome study is progressing well on the trial read out is currently expected in Twentytwenty for.

And for Akcea teacher Lrx, we're on track for data read outs in 2023.

In addition, we're looking to expand our portfolio of medicines like closely collaborating with illness <unk> densify intensely license a novel rare disease medicine on the wholly on pipeline and we're searching for a potential third party medicines that complement our rare diseases focus and capabilities.

With that I'll now turn the call over to call to discuss our commercial efforts in more detail.

Thank you Damian and good afternoon, everyone.

We achieved exciting commercial milestones in the second quarter with Tech study on way liberal, including securing pricing and reimbursement in several key markets across Europe, and we're making good progress with pricing and reimbursement discussions and other European markets.

Check said he is now commercially available in 15 countries, we're competing effectively in countries, where we have launched and patient growth continues to accelerate.

We leveraged commercially available in Germany, Austria, Greece, and through an eight to you in France.

Let's start with Tech study, we saw continued revenue growth from the first to the second quarter.

We're growing the number of patients on commercial check city across both North America and Europe.

Patients and doctors are looking for an alternative solution to hospitals are infusion centers for treatment.

Our next city as a subcutaneous self injection, which means patients can take chegg study on the comfort of their own homes.

In the second quarter, we had patient switch from other therapies to tech savvy and doctors are seeing the value of tech city for patients naive to treatment with A.J. TTR with Polyneuropathy.

Disadvantaged coupled with the demonstrated efficacy and manageable safety profile continues to be the driver of check said he's growth.

Let's now turn to our progress with Tech study in the U.S., where we are competing effectively for naive patient starts.

We continued to see more new patient start on Tech study in the second quarter.

This highlights the unique value this medicine brings to the U.S. market as an at home treatment.

Patients have stayed on therapy, and we are seeing patients remain on therapy due in part to our patient support program Akcea connect.

Our ha TTR compass genetic testing program now has more than 2000 physicians testing and over 10000 genetic tests have been administered since launching less than two years ago.

We experienced a slowdown in testing in the second quarter. However, we continue to see newly diagnosed HD TTR patients appalling neuropathy start on Tech study.

As a result of our robust physician outreach, we are continuing to see new physicians prescribe tech savvy and those with Tech city experience are choosing this medicine for additional patients.

In terms of market access we have 96% of total U.S. commercial lives covered today and we have negotiated long term coverage that secure 75% of commercial lives through 2023.

These positive signs of continued progress with our U.S. pair strategy demonstrate our ability to provide tech study to a broad population of patients in need of treatment.

Q2 was an exciting quarter for Tech study in Europe, we continued to grow the number of patients on commercial therapy in the markets, where we have already launched we secured final pricing and reimbursement in Portugal, Italy, and Spain, and we are in the process of converting patients currently being treated with tech steady from early access programs.

Over to commercial therapy.

These markets have significant potential, especially Portugal due to its endemic population.

In Austria, We recently announced the Tech study was officially approved for reimbursement.

Fix studies, the only medicine available for HIV, TTR with Polyneuropathy patients and Austria for at home subcutaneous injection.

In Canada, we concluded negotiations with the Pan Canadian Pharmaceutical alliance with a letter of intent and we have secured liftings in several providences clearing the path for reimbursement for the majority of our current patients.

In addition, we have secured multiple agreements with private payers in Canada.

And in Brazil launch activity continues to progress with new patient finding and PTC remains engaged in pricing discussions with CMS.

Overall, we made significant progress with tech city in the U.S. Europe in Canada in Q2, and we look to carry this positive momentum for for the balance of the year and beyond.

Turning to weigh liberal.

We live or is the only approved treatment for FCS patients in Europe, where liver is commercially available in Germany, Austria in Greece, and we continue to enroll patients and are easy to you in France.

We have continued to grow the number of patients on commercial we live right in the markets, where it is commercially available.

All four markets added patients on commercial therapy in the second quarter, including our first patient on commercial therapy in Greece.

Our team is focused on building FCS awareness with HCP is supporting patient advocacy groups identifying additional patients and securing market access as we've all the typical launch sequence in Europe.

In Germany, we concluded pricing negotiations and we now have secured a fixed price for the duration of the contract.

In the UK, we are in the negotiation process with nice to secure reimbursement after a temporary pause due to the covert 19 pandemic.

In Italy pricing and reimbursement negotiations are ongoing and patients have access to a liberal through law three to six an early access program.

And we're advancing toward pricing and reimbursement in several other markets in Europe.

In Brazil, the PTC team announced the marketing authorization application has been submitted to Anvisa.

GTC continues to work to provide access to a lever to patients across Latin America.

In the U.S. as Damon mentioned earlier, we had an encouraging meeting with the FDA. This spring we are preparing the Resubmission, we'll keep you posted on the timing of the Refiling.

Our team is working diligently as we execute on both the tech savvy and we liver launches and we look forward to keeping you updated on our progress I'll now turn the call over to Damian to discuss our pipeline.

Thanks, Carl I'll start with Akcea teach youre lrx, the cardio transform and euro transform phase three studies are underway with both our registry and wild type forms of future on the doses.

This represents another important milestone and further demonstrating akcea allowances commitments, bringing new treatment option to patients living with teacher I'm like doses or 80 to your around the world.

Well the wild type I'm hereditary forms of HR under diagnosed and stable with limited treatment options available.

After a brief pause in studies, we are enrolling patients and on track for a data read out in 2023.

Next is enough days on Akcea April a allregs.

This medicine was recently granted fast track designation by the U.S. food and drug administration underscoring the significant unmet medical need a patients with lpa driven cardiovascular disease.

The phase three Horizons study is a 7500 patient cardiovascular outcomes trial, that's up and running with Novartis and is progressing well.

The trial read out is currently expected in Twentytwenty for Novartis is heavily investment program and its success.

Turning to Vista, Norcen, which has partnered with Pfizer.

Earlier in the year, we announced positive top line results from the Phase two study in a population of patients would hypertriglyceridemia type two diabetes, a non alcoholic fatty liver disease our NAFLD.

The phase two data will be presented at a medical Congress this summer.

Given the results of this study we see a lot of potential for this medicine. The program has advance towards the phase to be starts that will be led by Pfizer.

Finally, Akcea April see three Rx, which we are also very excited about in January we announced positive top line results from the phase two study of Akcea April C. Rx in the treatment of patients would hypertriglyceridemia, who are at risk for or who have established cardiovascular disease.

A more detailed data for this medicine, which presented at a medical Congress this summer.

We're on track to begin the phase three study Mfcs later this year the patient community and the market, we know very well.

We're committed to investing heavily in this medicine and we're also exploring the potential for use in other rare and broad disease indication.

Overall with our pipeline Akcea TTR Lrx Akcea eight fillet lrx have begun phase three studies.

Akcea April see three Lrx is moving into phase three and proven Orson is advancing into phase to be.

The consistent performance across our like a programs in terms of efficacy safety and Tolerability further validate the advantages of the next generation like technology platform.

Now turn it over to Mike to discuss our financials.

Thanks, Dan.

And good afternoon, everyone. It's a pleasure to be a part of the team here at Ixia and I look forward to moving order one soon.

In the second quarter, we had total revenues of $22 million revenue includes 16 million or commercial product sales from tech savvy and way liver.

Which is an increase of 66% year over year.

It's an increase of 8% on a sequential basis.

Research and development and license revenue under our collaborative agreements totaled $6 million and the second quarter.

Combined operating expenses were $57 million, we had an operating loss of 35 million.

We ended the second quarter, where the net loss of $33 million all on a non-GAAP basis.

We had a net loss of 49 cents per basic and diluted share a common stock owned by both our own acts and other shareholders.

And we look forward to continued growth as we continue to launch both commercial matter comes in additional countries. This year.

We ended the quarter with $390 million, good cash and short term investments and with our strong balance sheet, we're well positioned to execute on our current strategic objective and our vision for the future.

I'll turn the call back over to Dana.

Thank you Mike.

To wrap up we execute well in the second quarter, we achieved important commercial milestones I continue to see revenue growth with tech savvy and whenever we further advanced our broad pipeline or transformational medicines, and we strengthened our management team.

We have life changing medicines that we believe can have a significant impact on patients who are currently underserved.

We look forward to present in the phase two positive data for both Duke Norcen Alexia eight plus the three Rx at an upcoming medical Congress.

With additional country launches on the horizon protect set in middle of Rep that commitment from my own is to potentially license additional break. These medicines that are complementary to our pipeline and capabilities and with our impressive additions to the management team. We're very excited about the future of our company.

I want to close by thanking all of our employees patients caregivers and advocates for their share dedication to advancing supporting new therapies in serious and rare diseases.

Now open up the line for questions.

We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone, if you're using a speakerphone. Please pick up your handset before pressing the keys. If at any time. Your question has been addressed and people like to withdraw. Your question. Please press Star then to at this time, we'll pause amendments.

Early to assemble our roster.

And our first question will come from Chad Messer Needham and company. Please go ahead.

Great Good afternoon, and thanks for taking my questions.

Maybe just start with.

Diving, a little bit deeper here on me.

Users plans with proven nordson.

I, probably just but should that but the phase two dose ranging is that specifically in a look at higher doses I think I remember from the data back in January that did.

Comments that the safety profile would potentially support looking at higher doses and there might have been some interest.

And then when you say that the focus of phase three development is going to be on severe hypertriglyceridemia and CV outcomes is that I mean should I think of that is sort of guidance towards doing a CV outcomes trial in that patient population or worried there you know.

Maybe other studies and things that would be of interest.

Yeah.

Thanks, Chad Thanks for the question.

Statement here and its yet who can Orson it's a mouthful. So look we're obviously very excited about this program and the targets genetically validated target.

And the phase two data was excellent see the study.

Met its primary endpoint to multiple secondaries and.

We're very pleased with the clear evidence of reduction of risk factors for cardiovascular disease. There was no reductions in liver hot or hemoglobin able to see and yeah. Also is very well tolerated and very favorable safety tolerability profile. So so very excited about the program.

Pfizer have talked about advancing the program that was the sales to be dose dose ranging study and the objective of this study is two to identify the right Joseph phase three and so that's that's great. We've been sort of help him who take through that they have no sort of weve not disclosed that.

Those range of doses that were time to to look out in the to be study I think that's for information will come in due course.

Okay fair enough to can you remind me.

What doses have already been looked at.

Yes, so so I can I can now come back to on that but it's sort of in the 50 to 80 milligram range.

As my recollection, but I'll come back to I'm not exactly correct.

Hi, I'm sure I can find it to and then just just don't take setting those comments that you live testing the genetic testing sort of slowed in the second quarter, just just wanted to confirm.

I presume that was.

Colgate related and was wondering if you know as we've seen with you know a lot of sort of return to normalcy amongst a good people seeking care a couple of all sorts whether that.

Trended higher at the end of the second quarter into the third quarter, we're not.

[laughter].

Yes, so that that was co bid related it's as you can imagine patients I'm staying at home and no both physicians and not going getting genetic tested so the the decrease was due to cope with 19 by 100, it's causing some more information about that.

Yeah, Chad good afternoon, and thanks for the question. The short answer is yes. It was covered related we did see a bounce back at the end of Q2, and we've seen it pickup is well here as we kicked off Q3.

But we're continuing to that program to identify.

Positive patients and obviously then be able to connect with the physicians provides the right education.

That helps support those patients transition on detect study if and when appropriate.

The physicians and patients choose to do so so a very encouraged by hopefully.

The state's opening back up and the ability for patients to get NFC their physicians and be treated for for HR TTR.

Yeah, Great no mix makes less sense to me I saw doctors for the first time enjoying myself [laughter] alright, congratulations on the quarter and and a great city updates.

Yeah. Thank you Chad.

Our next question will come from Jamison coal, but be ammo capital. Please go ahead.

This is Jim Thanks for taking your questions and congrats on the progress. So a question on a pro C. On your pivotal CF study when do you expect to release the study design and protocol and where do you anticipate the majority of clinical sites will be located and the geographic mix of patient U.S. versus accurate.

And a follow up to that is how should we be thinking about that study potentially taking away patients from waiting for that.

Yeah. Thank you Jim some for the question again April C. I'm very excited about the program. This isn't in the targeted the independent risk factor cardiovascular disease. The study met its primary endpoints with robust triglyceride lowering 90% of.

Patients reach normal triglyceride levels below 150 makes the deciliter in study at the highest multi dose of 50 megs per month and the study also Matt it's a multiple secondary and exploratory endpoints and also very favorable safety and Tolerability profile. So it's a really good Lucky medicine, we're very excited about it and we will.

Plan to invest heavily in this medicine.

In terms of all the protocol so finalizing the protocol on our goal of fine. It's still too you start the phase three this year I will share with you. The details of the protocol. Later later on the year I think in terms of sites you know, it's it's a mix of sites.

You asked me European sites now I can get back to absorb more detailed information about bass.

You know fine yeah, absolutely.

Eventually we see this is a next yeah. When we think in terms of franchises here. So we live right is the commercial products doing well in the marketplace and with time with the next generation Madison comes through April C.

On the 2023 to four timeframe, we see patients moving over from weighted average equal C. Like Fcs patients and cause it's going to be a stronger medicine in terms of lower dose lower dosing frequency. So you know most likely will be hello.

Most once among low dose volume and and C. M protein from safety perspective is our hope and so we would expect to see patients move over when equal C gets approved for this patient population.

Great. Thanks for the uptake and congrats again on all the progress.

Yeah, Thanks, a lot of Jensen.

Our next question will come from Jim Birch enough with Wells Fargo Securities. Please go ahead.

Good afternoon to Nick on total Jim This afternoon.

First question would you be willing to split out the sale between the two drugs.

Hi, Nick Nice to talk to again, we are not sprint as slipping out with sales up to two medicines at this point.

Okay. Let me try another how about in terms of specifically protect city. Then you will see you knew still to switches.

No I'm very consistent we're still.

Yeah, Yeah, Yeah, [laughter], Oh, let's let's go to three knows that eroded and so if you mentioned in your prepared comments you have patients on the EPA meal.

Transitioning those on commercial drug.

Do you have a timeline school that and what the impact could be on sales in terms of patient numbers that are on the programs in Europe.

Oh for four way liver, you're asking about or for tech savvy.

Next I'd.

Exactly yes. So you know in most countries we have patients on EAP programs. For example in Portugal, we have many patients 14 patients on the VIP and so now that we've got pricing reimbursement in Portugal. We you know we are starting to see these patients.

Well, if its commercial commercial medicine, and so that's going to you the same in Italy, and Spain, where we also just recently received pricing reimbursements as well complex I had anything to those costs.

Yes, it's just a couple of quick comments around it it's going to take a little bit of time as you would expect it's depending upon country in terms of how that process will unfold.

Sometimes you have to get region specific hospitals in line and things like that so we anticipate you know it's already started by the way. So that really good news is we're already seeing commercial revenues in July coming out of Spain, and Portugal, Italy for example growth in the UK and Germany in Canada. So were.

Seeing a lot of progress already.

But in the southern Europe countries, you know, we anticipate it will probably take a couple of months. So on into probably mid Q4 mid to into Q4 before we finalize all of those transition to patients, but keep in mind not only are we focused on the existing patients that are being treated but we're also identifying new patients and trying to.

To make sure that any and all patients that need access to tech city anyway Liberal in Europe have access to it. So it's kind of a dual path that we are focused on not only with the IP, but also with new patients as their identified.

Okay.

And then just last one for me in terms of the no a study for TTR like.

Presuming that was a patients who would be eligible for commercial take city. So.

Are you is there an impact.

Seeing on commercial sales by patients going on so the trial.

Oh, Yeah, if it's the same patient population.

Ed free hereditary patients page eight youre pulling your occupancy so symptoms the Paul you're off the so it is a similar patient population. The study 140 patients 120 will go on Akcea teach youre Lrx plenti, we're going to into tourists and randomized six to one as we've described before.

Work, so yes, I mean that they ours. They are competing commercial commercial patients with clinical trial patients that is true.

Yeah, but you know take said he is here and now it's it's on the market.

It's available is doing well and it's up to pace, you physicians and patients to make the choice between one to two options that were providing both tech savvy, that's available commercially or to go on the clinical trials are eligible for the trial.

Okay, great. Thank you very much.

And our next question will come from Paul Mathias with Stifel. Please go ahead.

Hi, Thanks for taking my question is is Alex on for Paul I, just a couple for US I guess first off given your positive commentary around Roşia, specifically in the time of coal that I'm curious if you would describe.

Uh huh.

[laughter] coal bed is at headwind or tailwind and I guess qualitatively are you seeing more switching than you have historically.

And then second I was wondering if you could give us a little bit more info on the timeline of the way lever every filing in the U.S. I think last quarter. You had mentioned that you were on track for this year. Just curious if your lack of you know timeline update this time is koby related or what's going on there. Thanks.

Sure. Thanks, Alex for the for the two questions.

Yes, so in terms of you know.

Little bit 19, being a headwind or tailwind tailwind for tech steady sales.

Yeah, it's it's sort of.

Certain netting itself out I would say the batches of tech savvy or charity and at home subcutaneous therapy, and we have seen switches and we're doing well competing for naive patients. So we've all seen combination use. So that's that's good am however, the you know we patients or no.

Going so physicians and not getting generic tested as Tom mentioned, so they probably are netting themselves out at this point and the happy for clouds, adding some additional countries slot.

Yeah, just a quick comment just around the growth I mean, I was very pleased to see from Q1 to Q2 that we added new patients that we found new patients through our genetic testing program and that we increased our net revenues quarter over quarter and we've done that consistently since the launch of Tech study so.

Well covert is real and it's been a challenge and it had some limitations I think that we are we're operating effectively through it and we've been able to secure pricing reimbursement in some of these countries, which has allowed us to launch commercially in these countries sooner than what we had expected, especially in the face of some of the complexities and.

Overall, I think the execution of the team and the focus on the patient is really served us well, let's say, it's great to see actually.

And then Alex your second question was around ways of Rep, and our plans to refile and I mentioned in the script that we had a an encouraging meeting with the FDA and spring and based faced some this feedback you know where prepping the resubmission.

And.

Well, we're adding this time is oh, yeah real world data. So that's that's exciting we've got a lot of it now to add to the refile. We are conducting some increased procedural work to include this real words that real world data along two final data and so we.

We're not going to declare the timing at this point, we'll keep you posted on the timing of the referral.

But the important point here is that all the data exists today, so we're falling basis of existing data and we're just working today just forget the data collected and analyzed for the repack we file.

Great. Thank you.

Our next question will come from your own Werber with Cowen. Please go ahead.

Yes, Hi, I'm.

Okay fair amount of a follow up through the last question just don't worry Libra.

The lungs attributable data that you're looking to collect can you give us a sense <unk>, obviously would assume it's probably efficacy, but probably more relevant safety wise.

Is this data that is in some kind of a registry, but you have an access to or is this data real world data from providers due to two collects and analyzes.

Then I've a follow up as well.

Yeah, Thanks, Hichrom nice set mice to catch up.

So this this is an early access data in the UK. We haven't teams program, which is an early access program, where we would yeah. We have data from from patients who have been on the medicine and so we're excited about the data. Its you know we're collecting it now and online.

I think a as I mentioned.

And is is there a certain amount of follow up that you need from patients, let's call. It a year or so or is it just collecting data from as many patients can you kind of a certain number of patients kinda best effort based on whats available in submitted about.

Yes, so it's it's and collecting data sets with existing data from patients and we've done a cut off all data. So now it's just collecting the data and of course, there's there's there's there's compared to the original filing there.

Additional time that the patients have been on therapy and there's also additional data.

Looking back over to treatment to patients.

It's it's a it's definitely a stronger package of data that will be submitted here.

Okay, Great and I'm just a quick question on April eight with Novartis. The horizon phase three can you just remind us the powering for the primary endpoint and then are there any in terms along the way interim looks thank you.

Oh.

Yes. So there is an interim time points for this study and that Novartis hubs have mentioned such great in terms of hiring for the study I'm going ask it back to you on that mobile follow up I don't have an off the top my head I don't think anybody on the team on this call has it either no. So we'll follow you you're all.

On that.

Thank you.

Yeah no appreciate questions.

Again, if you have a question. Please press Star then one.

This concludes our question and answer session I would like to turn the conference back over to Damian Mcdevitt for any closing remarks. Please go ahead Sir.

Thank you for join today, we look forward to keeping you updated on our progress as we continue to execute on the tech savvy and we'll have a launches and build upon the strong foundation that akcea have a great afternoon everybody.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

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