Q2 2022 Ascendis Pharma A/S Earnings Call
As a leading product in our global growth hormone market.
And are planning to launch in Europe next year.
We have now.
Ashish successful phase III results for two.
Independent.
Candidates in a row and continue to see highly consistent.
Clinical trial hotels across multiple batteries and populations.
We believe.
That we are well positioned.
To drive sustainable long term growth with our three additional independent clinical product candidates in rare disease endocrinology and oncology.
Yeah.
Outside the same aggregate amount for innovation that we use for sky topper, our transcon PTH.
We believe.
That would be on track to become cash flow positive given our strong cash position.
One is in Europe .
Combined with the expected revenue from scratch offer in the U S.
Combined with the expected U S launch of Transcon PTH in Bergen Op next year.
Now, let me update you on each of our programs.
For transcon growth hormone.
Margaret is scheduled in the U S.
Our commercial strategy is to build schedule, but into leading growth hormone product in value.
While growing the overall value of the glaucoma market.
Our once we've discussed often.
It's differentiated from once weekly growth hormone products in multiple ways.
Reinforce its value.
Scott is the only once we do product to deliver on modified somewhat choppy.
Thereby maintaining the same mode of action <unk> tomo.
In addition.
It's the only product recruit similar tool storage, no preservatives, and an MTR cut which provides clear visible dividend to patients and caregivers.
<unk> has been delivered.
<unk>.
I'm also proud to share with you.
That's a sky 12, our auto Injector award pharma Opex 2022 patient centric design.
This prestigious award recognized pioneering drug delivery solution that has significantly contributed to improved design innovation patient experience and ease of use.
This changed.
The U S commercial leadership in May.
And the new leadership immediately implemented improved commercial Texas for Skype for Pat.
One of the goals behind these changes was to increase conversion of prescription to paid reimbursed therapy.
We have already seen the benefit of these efforts.
With a more than doubling sequentially, resulting in a reported revenue of $4 4 million euros in Q2 compared to one 9 million Europe .
In Q1.
Nearly half of Q2 revenue was generated in the months of June alone.
Okay.
We've also seen an increase in the number of <unk> prescriptions.
Written for new patients.
With a total new with now total number more than 1700 at the end of Q2.
A typical prescription has a duration for one year.
This is an increase of 75% compared to the end of Q1.
With this improved commercial taxes, we believe we are on track to achieve current 2022 full year.
It is compiled sell side analyst consensus subscribed total revenue estimate of around 25 million euros.
We continue our efforts to build transcon growth hormone to a leading global product with a global phase III adult growth hormone deficiency trial.
Our Japanese phase III.
Growth hormone deficiency trial.
Claim Turner syndrome trial.
Let us now turn to Transcon PTH.
Potentially our most valued product candidate in technology rare disease pipeline.
We just on Transcon PTH.
Two of these ppas and physiological levels or 20 hours to deliver the missing and Dr. <unk>.
We believe that <unk> has the potential if approved to become the first hormone replacement therapy to address the underlying cause of this disease.
For this reason, we believe that transcon PTH is the only product candidate.
Openly and completely address this more than $5 billion market opportunity.
The results from our phase III trials with Smith, the competitive composite primary endpoint and all key secondary endpoints.
Along with our phase II trial support our belief in this protection.
Even more promising.
57 out of 59 patients continue in the open label portion of the Phase II trial.
Two years of treatment.
78 out of 17 nine pizza continue in the open label portion of the Phase III trial.
All that reinforce our view that this product candidate.
Having an ongoing impact on these patients' lives.
These positive results were consistent across transcon PTH treated adult patients independent of the disease spectrum or conventional therapy dosed at baseline.
Which gives me comfort that basically all adult hydropower parison patient have looked at potential pain has the potential to benefit from treatment with transplant pjs.
Okay.
With this long term and pivotal data in hand, and our planned NDA submission in the coming weeks, we are focusing on preparation for the expected U S approval and launch in mid 2023.
We have <unk> three segment within the estimated.
70, <unk> hundred 90000 patient with chronic HP in the U S.
The first segment consist of adult patients in the U S. We previously or currently treated with short acting <unk> preparation.
Also most of them no longer have access to this treatment because of the record of net <unk> in the U S.
This patient group, we believe can be the early adaptors of Transcon PTH.
They have previous experience with <unk> treatment.
The second announced this segment consists of chronic adult <unk> patient.
Currently unconventional therapy with active vitamin D and cut some supplement.
Women PTA treatment.
In this segment, we will focus on building awareness for patients providers and healthcare system to understand the clinical value of <unk>.
Transcon PTH treatment.
The search segment consists of newly diagnosed adult patients with chronic HBV.
Patient in this group often develop chronic HBV as a result of mix surgeries on therapies.
Result, in the removal or damage to the payout of our clients.
In addition, we plan to explore the potential benefit of Transcon PTH more broadly in post surgical settings, and pediatric patient in future clinical studies.
Yes.
Expanding global reach for Transcon, <unk>, we expect and potential approval.
EU in Q1 2024, followed by long shortly thereafter.
For Japan, We plan to report top line results for our Phase III Parkway Japanese trial in the fourth quarter of this year.
Switching now to Transcon CMP.
The accomplished trial, our phase two randomized double blind placebo controlled clinical trial of Transcon CMP.
Children, the echo location from the age of two up to eight obtain continues.
We are pleased to report that we continue to see a better tolerated safety profile in all patient continue in good trials.
With the longest treatment duration now about two years without any dose reduction discontinuation.
All patients in the open label extension on our 100 microgram per kilo per.
Per week a dose.
We look forward to sharing with top line results from the double blinded placebo controlled part of the Columbus trial.
And the opening David extension results during the fourth quarter of this year.
We are planning to submit a new protocol.
R&D in the U S and to meet Cta's in countries.
In the <unk>.
Q4, this year in order to initiate a new global randomized double blind placebo controlled phase two trial in achondroplasia patients down to the age of two.
<unk> is expected to enroll around 80 patients and Michelle annualized scope velocity as the primary endpoint.
We expect to have the topline results of this clinical trial in 2024.
Okay.
With this we believe that we remain on track to all vision $3 three.
Growth of obtaining approvals for three endocrinology rare disease product by 2025.
Turning now to oncology based our recent progress on more and more convinced that we can make a paradigm shift in the treatment of cancer because of our unique transplant technologies.
The transcon telos seven agonist into starting to kick start their <unk> system inside the tumor where our hydrogel technology provides sustained release of the telos seven eight agonist, thereby activating the immune system without systemic <unk>.
Toxicity.
Enrollment continues in our phase one two trial of Transcon CLO equities.
Therapy alone and combination with <unk>.
A checkpoint inhibitor in patients with solid tumor will have failed prior lines of therapy.
The trial continues to show transplant CLR agonist is well tolerated as a monotherapy or in combination with a checkpoint inhibitor consistent with no systemic exposure of telos, seven eight agonist and demonstrating preliminary evidence of antitumor activity as monotherapy.
Or in combination with a checkpoint inhibitor.
Our transcon <unk> product candidate is designed to broadly increase.
Mixed stimulation of the body's own anticancer system and to become a new backbone.
For cancer immunotherapy.
The phase one two.
Dose escalation dose expansion trials continue to evaluate this product candidate alone or in combination with a checkpoint inhibitor.
Or chemotherapy in patients with solid tumors, who have faith.
Fair enough therapy.
During the second quarter, we dosed, our first patient in the combination transcon <unk> comma.
The checkpoint inhibitors.
The phase one two trial continues to show Transcon <unk> to pay the government is well tolerated as monotherapy.
Or in combination therapy.
To date, we have seen dose dependent increase in absolute the pursuit come along with increases in pseudo taxes subset of.
Seagate positive.
And NK cells without an increase.
As <unk> indicated they attended the tightened bias towards Peter comment activity.
There had been no dose limiting toxicities reported to date and we continue with dose escalation.
I will now turn the call over to Scott for additional details in his financial.
Before we open for questions.
Yes.
Yeah.
<unk>.
Cartoons.
<unk>, Colorado.
At the end noted we're in a very strong position to achieve vision three by three to become a sustainable cash flow positive Biopharma company.
With the U S commercialization of Skype profile near term regulatory filings for Transcon PTH and.
And nearly 1 billion euro on hand.
Reported use spectrum revenue for the second quarter more than doubled sequentially to $4 4 million Euro four from $1 9 million barrel in Q1.
Growth in Sketchup revenues reflects the strong increase in reimbursed demand and we continue to see robust increase in cumulative new patient prescriptions as summarized in the press release.
Based on the increase the success rate of patient reimbursement and our continued momentum gaining prescriptions I want to reiterate <unk> comments. We believe we can achieve that current at sandisk compiled sell side analyst consensus estimate of $25 million Euro for.
For the full year 2022, Skytrooper revenues, which consists of 14 publishing analysts.
Now turning to operating expenses.
Research and development costs for the second quarter were $90 4 million euro compared to $83 3 million narrow during the second quarter of 2021.
This reflects ongoing normalization of our overall R&D cost structure as more programs progress from early through late stage development and approval.
Selling general and administrative expenses for the second quarter were $56 6 million euro compared to $35 3 million narrow during the second quarter of 2021.
These expenses, primarily reflect higher commercial costs in the U S. Following the launch of Sky profile.
Finance income for the second quarter was $71 1 million Euro of which includes a net foreign exchange rate gain of $36 million Euro related to translation of our U S. Dollar holdings of cash cash equivalents and marketable securities and our U S dollar denominated convertible.
Senior notes to euro.
And a noncash $39 3 million gain from Remeasurement of the conversion option embedded in the convertible notes.
Finance expenses for the second quarter were $9 3 million euro primarily related to amortization of transaction costs and interest expense related to our convertible senior notes.
In future quarters, the following items related to the convertible notes, we will continue to impact finance income and expenses.
First re measurement of the U S dollar denominated convertible notes from U S dollar into euro.
Second re measurement of the conversion option embedded in the convertible notes, which <unk> accounting rules require us to re measure on each reporting date.
Third interest expense related to the cash coupon and finally amortization of costs from issuing the convertible notes.
Yeah.
Sure.
Overall, we had a net loss of $81 3 million euro or 146 euro per basic and diluted share compared to a net loss of $134 4 million euro or two five euro per basic and diluted share during the second quarter of 2021.
We ended the second quarter with cash cash equivalents and marketable securities totaling nearly $1 billion Euro, which we believe will enable us to become cash flow positive.
Turning to the remainder of 2022, we expect our operating expenses to increase modestly as our pipeline matures and as we prepare for anticipated product launches.
Let me now also provide you an update on timing for select milestones for the remainder of the year.
For Transcon PTH were.
On track for a planned NDA submission this quarter and a planned European submission in Q4.
And for a pathway, Japan topline results are expected in Q4.
Our transcon CMT.
We look forward to sharing the top line results from the double blind placebo controlled period of the accomplished trial.
And also the open label extension results during Q4.
And we plan to submit regulatory filings in Q4 for a new randomized double blind placebo controlled phase II trial in children with achondroplasia.
For Transcon, <unk> agonist topline monotherapy and combo therapy dose escalation data.
The phase one to transcend.
101 clinical trial are expected in Q3.
For Transcon <unk> beta gamma monotherapy topline results are expected from the phase one two I believe trial in Q4.
Within oncology, we expect to submit an IND or equivalent for a phase II cohort expansion in order to evaluate the combination of transcon <unk> agonist and transcon IL two beta gamma therapy in Q4.
And finally, we plan to announce a third therapeutic area by the end of the year.
As you can see it's a busy second half of the year percentage with key catalysts across the pipeline.
<unk> and endocrine rare disease and oncology.
Yeah.
At the end and I noted with approximately 1 billion euro on our balance sheet, we have the capital to fund our growth initiatives and we are positioned to hotel version three by three cash flow positive.
With that operator, we're now ready to take questions.
Okay.
As a reminder to ask a question you will need to press star one on your telephone please.
And Lee will be compile the Q&A roster.
Yeah.
Your first question comes from the line of Jessica Fye from Jpmorgan. Your line is open.
Hey, guys. Good afternoon, Thanks for taking my question.
I have one high level question and then a few specific ones.
First what are the PTH.
Or Sky Trust the assumptions that are embedded in your expectation to become cash flow positive and just to confirm should we take that to mean, you expect to become cash flow positive without the need for additional capital.
I'll stop there and come back with the other product specific ones.
Thanks.
We are in a unique.
Unique position at our centers.
During the last years, we have buildup and unique pipeline of five independent product opportunities.
Each of them have the plus.
But what is unique with the pipeline.
We believe we can make it extremely successful.
We have not paid in one single clinical trial.
We haven't managed to move each single product opportunity.
Preclinical stage two capes Skytrooper approved now in Europe , and U S. We have moved transcon PTH from preclinical into positive phase III currently.
And we now expect to file in the next weeks here in the U S.
If you just focus on these two product opportunities.
And to be profitable and to be cash positive days two different element. This is like a pocket.
You fill in the pocket.
When you start with some water.
And then you have a hole where thinks run out.
We started with 1 billion of water now.
And then we fill them with revenues from scratch ROFO in the U S.
Our expected launch of Transcon PTH next year.
And then we have a home.
What is interesting now we have such a mature pipeline, we've not really in reality, increasing R&D expenses, because we take product out nearly in the states.
<unk>, let me take it in.
So this is why Scott Eni the management and everyone. Feeling now we are in a position we can hit profitability with our current.
One building in that bucket of cash.
Scott any additional thing.
I don't have anything to add to that yes, that's right.
Great.
The other ones I had was just.
How many of the.
1707 patients who have gotten a sky trust the prescription have received upon or started taking sky trough at this point.
Then switching to CMP.
You expect to learn from the accomplish data and the open label extension data that will become available in the fourth quarter.
And I'm also curious of your thoughts on it seems like now two other agents in the space have had a tough time.
Detecting an efficacy signal in kids under age five what proportion of the kitchen you accomplished trial are under age five.
Yes, still a lot of questions, let me start on that.
Part because then I can still remember most of the question here in the later.
Hagen hours, but I.
I do believe that you need to think about how we did start our Congress.
We designed it out from that perspective is that we wanted to really to see.
The expected.
Strengths of our product opportunities.
And we did it in a way, where we double blinded and having an intern.
Placebo control, where we randomize each single after for cohort two 1% or so.
We basically have in outcome. This time the same amount of.
Placebo as we have treated patient.
<unk>.
<unk> different compared to anyone knows where some trying to compare to historical data somebody trying to compare to pre cheeseman outcome that is a bit different. So we basically will have one year of annualized growth velocity data.
<unk> controlled double blinded trial with about 10 to 12 patients in each city.
We will pay us to position that we really want to treat all the patients. We will not just selected to Slash award anything deep indeed that basic Tankful viewpoint, you should have a treatment option and we believe we also have such a strong product opportunities we could see an effect there.
So what we are doing and what we expect to share with you in Q4, we will share with you.
All the data. So you can take an informed decision about the strength of this product opportunity how it can be lethal to the patient we will show you the annualized growth velocity for each single cohort.
One year, we will compare to placebo mover keep your absolute value. So you can make a real adjustment and not just a bit because this is the only way you can do it we have a show with a much more important also the safety profile how is safe for this treatment group because that is priority one in our Peter Asics.
Eight unique to be safe.
But what is more.
Interesting we have patient now that don't have been new try for more than two years.
Meaning is that there had been an open label extension trial for up to one.
We have not seen any single patient.
This trial.
All the patients are still in there.
And our hope is feeling that is keeping me comfort.
That if you in up to two years treating pediatric population and not cheap anyone's Lee is because the seat metric.
Also feeling thats very important to show to you what is happening in open label extension because the first group the six microgram group other call it wasn't there Luke.
In treatment basic got filtered up now to 100 microgram. Because then you will have basic and duration, where you also can follow.
And patient groups that are treated for one year with six microgram and then suddenly got switched up 200, Michael and then see what is the expected outcome. So we basically will have to wait to Josh and we will be as we always are known when we shift to Egypt transparent, giving you potential Tomas data sometime.
But we really want to share to you really can understand why we are excited about our product opportunities.
Okay.
Just do that explained.
My excitement about CMP.
Right.
Okay.
Yeah.
As a reminder, please limit your questions to one question and one follow up on the should you wish to ask more questions. Please press star one again to reenter the queue.
Your next question is from the line of Josh <unk> from Evercore. Your line is now open.
Hey, Thanks for taking the question couple of questions about Sky Trophy first in terms of access dynamics and parameters can you give us a sense of.
The percent of targeted covered lives that are able test.
Excess sky trough, either as a frontline option over a switch option.
Any step at it requirements and we've also heard some concerns about the device potentially jamming at times.
Maybe you can help quantify the rate at which that is occurring.
Whether there are any mitigation steps to correct that especially as novo Nordisk, maybe maybe launching.
Once a week with with.
Our competitive devices. Thanks, so much.
Yes. Thanks.
Yeah.
Let me start on the last question, it's always easier for me to remember Scott can you give me the same for the first one.
Just talk about the schedule for device.
When you talk about device you talked you through.
The patient and how you basically have a treatment option for their pension and what we did develop with us cutover and it's developed ultra injector, which we just really got the wall fault, because the basic how robust patient frankly and things like that.
Showing.
How do we really have succeeded with what we try to develop with our best guide towards the outer injector.
So one of the things we wanted to build in this alternative is basic to have room temperature stability.
And this has really been the key element for the leading position of the daily growth hormone market, because it's really a huge burden for patient caregiver August to have accrued chain stores, when you're traveling or other things just moving from one home to the <unk> homes doing other things and this is why we built it up in this.
But one of the unique wheat buildup what is single use conference because it also gives us unique opportunities for the caregiver never being down it really gives the child and injection that week or not.
And we really seeing unique benefit good desk what.
Great.
From every week.
An update about complete because in the complaints we haven't actually monitoring about what do we see out in the market and now we have.
<unk>.
Basic Charleston patients in treatment and other things like that so but not of start to come in.
I can guarantee when I look them numbers there.
Not getting any data.
That indicating that we have any issues with what you are referring to with the auto injector, we cannot see from the data sometime perception are stronger than reality, but when I look at the data we have new indication from that perspective.
The first question.
I think the first question, we can answer but we can answer under this assumption that is basic is duration is changing.
Because as Youll see in our press release, we have about.
57% of U S lives covered but it means that it's really is at and highly diverse positioning and disposition is changing daily.
By day.
Week by week, because as Joe is doing with his people the commercial team Theyre trying to bear Margaret assess team to improve every day every week that our patient and the physician has the most optimal way to get access to.
The patient of schedule.
Scott do you have any comments to offer such a joke.
Yes, I would just.
Maybe augment that Josh by saying there is a variety of coverage and we believe that our formulary positioning.
Basically in line with our goal of preserving and growing the value of this market specifically for our sky drove our product, which we believe is a premium product.
Yes, I think what are the key element.
You can have different kind of strategy and position about our brand.
About the schedule for how we want to be.
Having an oral strategy for us.
We have a superior product, we believe we have a best in class product opportunities.
We believe the promises that we have discussed Rover is providing the endocrine benefit type of patient should to service.
What we see today is that when we position that into the market. We have two goes.
To be number one in value in the U S market.
Also want to ensure that the entire growth hormone market will grow.
To a level from the current 1% to 3% to a higher level, because we are providing a better treatment outcomes for patients and therefore from the society perspective, we can somebody sure that benefit everyone.
This is why we believe our market access strategy is building on not being in a position, where we not getting and taking market assess.
Except that we feeling pieces into the framework, where we believe we can see these two elements.
Joe I would like to introduce you to Joe Joe is the head of our U S commercial team and Joe do you have some further comments to this discussion.
Thanks Scott.
Josh, but yes, I'll just reinforce.
Strategy around gaining.
Profitable access for Sky Trophy, and Thats something were continuing to execute on it.
Yan has mentioned a couple of times already.
Commercially we have made some tactical adjustments by reallocating resources to capitalize.
We know we have access opportunities with better targeting and we're also reinvesting in areas that has and will continue to help us increase the number of patients that get reimbursed.
Look at June by itself, representing half of our revenues in Q2, It's an example of our approach working.
We're just getting started.
Thanks very much.
One thing I would like to say I would like to see what we have seen here in the last two quarters now where we have doubled the revenue.
Last quarter to this quarter.
Our goal as we can continue doing the business of how we want really to build up the brand and I believe Joe and the entire.
Commercial team because really from sonesta team.
Really now dedicated to get that to happen we believe.
Okay.
Patients in the U S with growth hormone deficiency to search to have the treatment option of scratch over and get what we believe the benefit of this treatment.
Yeah.
Yes.
Your next question is from the line of <unk> Ahmad from Bank of America. Your line is open.
Hi, Good afternoon. Thank you for taking my question.
Yeah, and I just wanted to get your thoughts about the competitive landscape for achondroplasia. So we know about the competitive advantage your products would have potentially.
On dosing dosing frequency.
I also wanted to get your thoughts on bridge bio, which recently did show some early stage data for an oral molecule that is developing it's early of course it still be several years ahead, but I guess in theory, how do you view the potential profile of an orally delivered drugs.
If efficacy is somewhat comparable to your proposed weekly injection. Thank you.
Yeah.
<unk>.
It's not really my job to make comments about other companies' products.
But I always willing to share my personal analysis.
The entire competitive landscape.
First of all my fundamental.
Terrific perspective, and this is where all of us believe.
<unk> opportunities mode of action.
Direct the clinical outcome in the end independent on how we do the clinical trials.
Number one.
This is in oncology.
Doc.
Debt position into a pediatric indications.
From the mode of action.
And where the target tissue are integral place.
I would need to be convinced by data data and data that is safe.
Because that is.
Number one it needs to be safe in the.
Doses were.
Provided that took effect.
And therefore attrition come in when I look at the data.
I have no clue how to analyze it.
Because.
One of the key element I need to understand <unk>.
Cause I've seen so many many many many data with annualized growth velocity for three months six months and everything.
If you don't see a delta it's meaningless for me.
I need to see absolute growth velocities are need to see background I need to see other things like that so for me I have new.
Dividends and no opinion that this product is function or not because I can personally not Josh.
For the competitive landscape is that.
Safety is number one.
But I think a condo patient.
You cannot compromise what ever you talk about you can never compromise safety.
And this is why we believe.
To get all of it.
Yes.
See absolute growth velocities are need to see background I need to see other things like that so for me I have new.
Dividend and no opinion that this product is function or not because I can personally not Josh.
For the competitive landscape is that.
Safety is number one.
With ASIC echolocation.
You cannot compromise what ever you talk about you can never compromise safety.
And this is why we believe.
To get all of it.
Yes.
CMP Parkway has now proven with so many patient data is extremely safe pump with <unk>.
So now we just need to adjust need we need to find out how we can optimize the treatment regime to be really get the best of the CMP treatment and that is what we hopefully we'll get some clues about we can just need we need to find out how we can optimize the treatment regime to be really.
The best of the CMP treatment.
That is what we hopefully we'll get some clues about we can give you some comfort that as possible when we come out with our data in Q.
Q4, with basic are coming from a patient group from the 8% to up two 8% Tim because we also.
Believe that should have a treatment option.
Okay.
Okay.
<unk>.
Please standby for your next question.
Next question is from the line of David Lebowitz from Citibank. Your line is open.
Thank you very much for taking my question.
I guess with.
With respect to the the number of prescriptions at this point.
To what extent are the patients.
Getting reimbursement overall.
And to what extent are patients.
Giving discounts or for.
Okay.
The launch at this point and in addition, how long are the prescriptions for.
<unk> mentioned as far as duration.
Two because a prescription is for one year.
Two because Ah patient.
Trucks four months some patients will Kate talks for three months, but obviously, it's much more small small comment just to get a one month's supply.
So when we talk about a prescription is basic will have a duration for one year before start to be renewed.
What Joe has indicated.
We had the overall goal when we launched.
Scott over here in the U S. We wanted to build it up in the leading brand in value.
Yes.
We also wanted to do it in a glaucoma market that will be increase in value at the same time.
Awesome that peoples of our commercial launch strategy.
Our target is this strategy.
And you can have different tactic to achieve our overall goal.
And what Joe and.
His team has done is really optimizing this tactic and notices wide receiver results now, where we really see that benefit opportunities of tactics and how really to achieve our corporate goals.
On how we want to develop skytrooper. So what we're doing now we are converging on a.
Higher and higher rate.
Prescription over to reimburse.
And that is our goal because this is where we recognize revenue we don't recognize revenue upfront prescription we recognize revenue when we sell into the system in the U S that distribute the truck to the patients.
Okay.
Got it.
And with respect to an initial.
Prescription how long does it take until.
That patient becomes a full paying customer.
And do you have enough data to see how thats evolved since launch.
We have a lot of data and it's evolving.
And once per months some of them as few days some of them.
Do not know because theyre not guided yet but Joe.
Comments about some of their own metrics and how we really improving.
Are we really can optimize this because this is one of the way obviously, we have changed our tactics.
Hey, David.
Really varies quite a bit from patients that already come in approved reimbursed.
To go on our free drug program.
Within those 700 patients prescribed.
Prescribed <unk>, but there is a subset.
And again, our reimbursed rather quickly.
That do go on our free drug program and then there is another subset that don't go on free drug but are going through the reimbursement process through medical exceptions.
Sometimes appeals, but at this point, David we're not willing to share specifics about that data, but I can tell you that some of the tactics that we have.
Adjusted are really.
Showing that we can accelerate that process to where we are getting approvals much quicker now than we were before.
From the Pbms and the payers, whether we're on formulary or not on formulary, we're seeing Ah patients at the authorizations in both categories.
Okay.
Thanks, Joe.
An additional comment I would just say importantly, Dave.
Increase in Skype broker revenue from Q1 to Q2 reflects.
It reflects the underlying increase in reimbursed demand and you can see there the acceleration based on the tactics that Joe and the team are implemented.
Thanks Scott.
Your next question is from the line of Lee <unk> from Cantor Your line is open.
Hey, Thanks for taking my question.
I guess I'll start with Transcon <unk>, just can you remind us I guess.
From the phase <unk> data would be.
<unk> got good clinical.
And I guess other than the gorilla.
<unk>, what other clinical outcomes that we should focus on most relevant.
<unk>.
It's extremely interesting.
Christian <unk> from the perspective is that from a regulatory perspective that has now been established of a procedure that the primary endpoint is annualized growth velocity.
And two is when a precedent has been established is really really hard to drive away from that perspective. So this is why we have focused so much on annualized growth velocity as the primary endpoint because that is how regulatory one to have approval of this product but.
100% right.
100% right.
Annualized growth velocity is only an indication of effect.
We want to treat the comorbidities, we want to improve the quality of life, we want to improve that.
<unk> and <unk> spend.
And this is why I am so.
And honestly I'm thrilled because if you have so many pediatric patients now going after two years and none of them have stopped.
Ms drug or anything but continued continue to be on treatment.
Is some clear benefit.
In the trials.
At least that's my belief.
What we love to do and this is what we're going to do when we have online at all the data we looking on all the different element on clean data and other things. So that we hopefully we can see.
Potentially some effect that'd be basic can follow up on and try to understand data.
But currently.
I have only a lot of.
Ideas on a huge menu list of what we potentially could see but I need to look at the data and understand the data to susser level, what we can do it but what we like to do that.
This is why we now are in EG and the <unk> trial, which we ate Seo patients Peter.
Children from too.
That basically are starting.
Starting now on treatment and we know when we have analyzed the first series of data we potentially can.
Tick.
In corn for that area into our phase <unk> trial and potential start to have that in our interaction with regulatory agencies of taking them secondary endpoint or other pumps.
But we chose and we believe.
And hope that we can prove some benefit that really addressing the cobalt BTT.
Okay great.
So I guess just a follow up here you mentioned, maybe the regulatory pathway and maybe a possible maybe accelerated once I just wonder if you have any interaction with FDA about this possibility and again get a sense of what the ancient <unk> thousand 19.
T.
Because it seems like trends kind of 14th quite safe, So I wonder how you're thinking about them.
Constantly premiere.
I can start with my thinking of them Dana can follow up but I think the key element. We are waiting for is the data.
Its must must put up to as much more.
Effective to come and discuss when we have the data here in Q4 today, we can only speculate we can think but we need to see the data and then we can stop the prostitute dialogue with regulatory agencies in different places in the world to find out how it can be as fast as.
Possible get this unique product opportunity out to the patient on a profit perspective, Dana do you have any comments.
Yes, Youre absolutely right, we haven't had any.
Indication with FCA and our plan.
To take the place they accomplish data.
And then.
We are already planning in.
Page <unk>.
Then we will have.
Two studies eventually that will form the basis of our discussion.
Uh huh.
Yeah.
So more to come after the data.
Yeah.
Your next question is from the line of Vikram <unk> from Morgan Stanley . Your line is open.
Hi, good afternoon, Thanks for taking my question.
So I had one on scratch sofa.
As you've progressed through another quarter of the launch are you still seeing the majority of patients coming from.
Being a switch patients versus treatment naive patients and.
Four patients switching from other therapies in a particular region that you are seeing a majority of efficient Switzerland.
I think still we see what the actual.
Was experienced in the first.
Quarters or the first full quarter in Q1. We also saw that include too we see.
A small majority of the patients coming from switch patients. So it is a small majority of patients are switch patients.
There is no single.
PD growth there coming from its basic broadly among all of the data crops.
Honestly this is pretty expected because there is no difference between the daily growth hormone all of their marketing tickets.
So there is no difference. So I think this is follow the science that is no different with data growth, we see no switches from anyone that is preferable.
Got it that's helpful.
And a follow up question on a separate topic for the transcend <unk> 101 data, we're expecting to see in the third quarter here.
First what parameters of data do you expect to report out on and then how are you defining success for this readout and what is the internal hurdle youre trying to meet here from this data set.
Okay.
Yes, I can start initial steam.
<unk> is on the coal from power.
And second follow up the.
<unk>.
<unk> is where we take our transcon telos seven eight agonist, we injected inside the tumor in patients with solid tumor.
Is that weakness is to kick start the tumor.
That you more logical system and at the same time Youll provide belo systemic exposure to ensure that you having an extreme say.
So one of the element, which we already have disclosed has shown the successful design of this product opportunities. We have disclosed per safety, we have disclosed the PK profile, we have disclosed how we have sustained released inside the tumor with a low.
Systemic toxic toxicity. So from that perspective is that what we are optimizing now is how we can also see the clinical active.
Activity or good target engagement in injected tumors and not injected tumor and.
<unk> and her entire team has decided a huge claim both related to biomarkers tissues.
Things are debt and payment.
Sorry, Stena you can explain.
How are we progressing and when we will select and recommendation phase two dose.
Thank you Yang.
So at the end of quarter three this year, we expect to have a formal analysis of the phase one dose finding portion of transact at 101, we expected yen mentioning will summarize what we have seen in dose escalation cohorts.
For monotherapy in combination with <unk>.
Our PK comp dynamic data clinical safety and initial look at anti tumor activity.
Does that answer your question.
Victor <unk> line is already closed.
Okay.
Next question. Our next question is from Joseph Schwartz from SBB Securities. Your line is now open.
Hi, I'm <unk> dialing in for Joe. Thank you for taking our question.
First one is on Sky <unk> I was just wondering what are some factors that went into building our company to reach 25 million euros by yearend could weeks and when can we expect to see an upper bound and guidance and I have a follow up.
So.
What we are doing at the company is that we have.
Coming off with clear.
Thanks.
<unk> of some of the key parameter we are following the launch with.
What is giving you now is that.
Revenue that we have seen.
By quarter for the last two quarters, we have seen more than 100% incur.
The increase in the revenue from last quarter to this quarter.
We believe.
We can continue doing that because we see the continued execution on some of the Kpis that is really following the lumps.
And I think we have provided you a guidance today.
Yes.
Come up with Ikea measured.
We feel comfort.
We can reach.
What you for cell site resource hub in a consensus.
We feel confident we can reach that.
I don't believe we can move.
Sure.
Into more.
Discussion about what our own expectation is we give you the comfort that the guidance that you have is consensus we can reach.
Okay. That's helpful. Thank you and then my next question is on <unk>.
I was just wondering if you could elaborate more on your phase <unk> trial that you plan to conduct.
On a comparable net your two phase two trials and do you have plans to go higher than the 100 micrograms per kg per week at all your patients and your own.
On your OLED study.
Yeah.
First of all one of the.
Element in.
In conducting this trial is that we have and.
Ashish trial.
And we have.
100 patient now I think in May.
Mainly Europe and U S.
We have not seen any of these patients move away from our national history study vested in that.
And basic there have a heightened level of expectation that potential will it gives them a treatment option.
And that is exactly one of the reasons why we.
Any change in the phase <unk> trial to give them.
A treatment option for Pollock.
From our side.
It also is a trial that will give us the insight in potential how we can explore oil per meter.
Yes.
Annualized core philosophy, which are the key permit we have now been focused on.
The Companys trials.
When we have the data in Q4, we basically will analyze the data back and forth as we always do go deep in the science trying to understand the data look on each single patient what's happening what is done and then we will potentially can incorporate.
Although.
Secondary endpoint in that trial and build it up in our.
Discussion with regulatory agencies.
So the purpose.
With phase II.
Basic building.
Clinical evidence.
Of what we can achieve returns come CMP.
This concludes today's conference call. Thank you all for participating you may now disconnect.
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