Q2 2023 BioCryst Pharmaceuticals Inc Earnings Call
[noise] today, and welcomes Biocryst second quarter 2023 earnings call Oh.
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Thank you very much good morning, and welcome to Biocryst second quarter of 2023, corporate update and financial results Conference call. Today's press release, an accompanying slides are available on our website participating with me today are C. E O John Stonehouse C F O Anthony Doyle.
Commercial officer, Charlie Guy or and Chief R&D Officer, Dr. Helen's back right.
Following our remarks will answer your questions.
Before we begin please note that today's conference call will contain forward looking statements, including those regarding future results unaudited and forward looking financial information as well as the company's future performance Andorra achievements. These.
These statements are subject to known and unknown risks and uncertainties, which may cause our actual results performance or achievements to be materially different from any future results or performance expressed or implied in this presentation you should not place undue reliance on these forward looking statements for additional information, including a detailed discussion of our risk factors. Please refer to the company's documents filed with the Securities and Exchange Commission.
Which can be accessed on our website. In addition, today's conference call includes non-GAAP pro forma financial measures for a reconciliation of these non-GAAP measures against the most directly comparable GAAP financial measure. Please refer to the earnings press release posted in the press releases section of our Investor Relations website Biocryst dotcom.
I'd like to turn the call over to John Stonehouse.
Thanks, John the strong step up and revenue that we expected and achieved in the second quarter and the consistent steady growth, we continued to see patients on treatment.
Physicians as well to achieve no less than $320 million Orla Dale revenue for the year.
And $1 billion at peak.
Charlie will share more of the details, but I want to point out the success, Charlie and his commercial team has had.
In a rare market, where there are many treatment options for patients and yet they're still switching to orla Dale that is great execution by the entire team.
Charlie and I also recently attended the U S. A J E a patient summit in Orlando, Florida.
This was the first major gathering of U S. H a U patients since 2019.
Which was before the approval of all the data.
A record 1200, H AE patients and their families were in attendance.
And it was an amazing opportunity for us to showcase our company and make connections with this community.
Patient activation is a major part of our strategy in this event was a fantastic launching pad for that.
Lastly, we're very excited about the progress, we're making with their pipeline.
We will host and R&D day on November 3rd at our Labs in Birmingham, Alabama, we.
We plan to show you much more about additional assets and programs we haven't discussed previously.
Our hope is you will see more clearly how our structure based drug designed platform focused on pursuing first in class or best in class medicines for patients with rare disease allow.
[noise] allows us to spread the inherent risk of drug discovery across multiple programs targets and diseases.
And increases our probability to get at least one of them to the market to.
Followed the successor board of the day off.
We look forward to sharing more with you in November and I'll hand, it over to Charlie.
Thanks, John .
Second quarter results for early data rolled out as we expected.
The longterm linear growth and patience on therapy continued and revenue revenue jumped following the first quarter prescription reauthorization process I'll provide more color on both.
Growth in patients treated with Orla day O continued at the same consistent pace, we've seen over the past two years <unk>.
After a strong first quarter in the United States for net patients added to therapy. We added about the same number of patients again in the second quarter.
This is what linear growth looks like.
We also made great progress in getting patients to paid therapy, adding the most net paid patients and a quarter since Q2 of last year. In fact, we added the exact same number of net paid patients as a year ago.
We also had a very similar number of discontinuations as in the second quarter last year, even though our current patient base is significantly larger so the discontinuation rate continues to go down.
Again linear growth.
As we forecasted revenue took a substantial jump in Q2 over Q1, just like it did a year ago.
The biggest driver was the continued growth in our patient base, but we are also improving our ability to get patients to paid therapy.
In January and February for example, roughly 34% of patients run free product during the heavy reauthorization period that.
That fell to about 32% by the end of March.
By the end of the queue to the percentage of patients on free product fell to 30%.
So we made a lot more progress after reauthorizations were completed.
Every percentage point of our current patient base that we moved to paved therapy is worth about $4 million in annual revenue.
So these improvements are very meaningful.
Based on the trends we see in the work our team is doing we expect to see continued steady improvements in that percentage over the next few years. We're confident we will reach our long term goal of getting over 80% of U S patients on orla data to paid status.
The bottom line in the U S has this.
We are growing total patients on therapy at a very consistent rate every quarter Justice. We have done since launch and we are getting even better at moving patients to paid therapy.
For the rest of 2023, we expect revenue to track along with steady patient growth to reach note low less than $320 million in global revenue for the year.
In future years, you can expect the same pattern based on patient growth trends and insurance seasonality Q1 revenue being slightly down based on Reauthorizations Q to being a larger bump in revenue and steady growth in Q3 and Q4.
The U S. Currently accounts for about 90% of global sales, but this may overshadow, how well we're doing in Europe and the rest of the world.
What we're seeing right now in Europe is very similar to the U S steady quarterly growth in patients on therapy.
We are laying the groundwork for similar patient growth trajectories, as we launch and more and more countries around the world on the way to 20% of peak global sales coming from markets beyond the U S.
As John said earlier, we recently attended the U S. Haa summit in Orlando, along with 1200 patients and their family members.
Their interest and enthusiasm showed us how much demand there is for an oral once daily prophylaxis therapy.
We are seeing the same thing around the world our teams and our partners in North America, Europe , Latin America, and the Middle East are doing phenomenal work to bring orla deyo to patients who need it.
We keep growing and we keep improving.
I'm, so proud of our global teams and how they are bringing this transformative therapy to patients living with H E E. All over the world.
Helen alternate over to you.
Thanks, Charlie.
It was exciting to hear from so many patients at the Haa summit about how orla Deyoe has control their attacks and change their lives.
H a is a hereditary disease passed down from parents to children and we spoke with many parents who wants to know what progress we are making towards bringing early damage the pediatric population.
The burden of H E E and then protect and particularly the burden in injectable therapy is especially difficult for children.
That is why we're focused on the future pediatric indications what oral once daily Orla Dal and the apex P trial, including evaluation of the new formulation using granules to best meet the needs of children with H E E.
Apex P is up and running at multiple sites and I'm pleased to note that enrollment is proceeding is affected.
Turning now to the pipeline, we're looking forward to our R&D day in November we will share with your details on new programs and molecules that you haven't seen before.
Goal with our pipeline is spring first in class or best in class molecules.
Since with rare diseases and to have a second product and more following that which we bring to market as we did with oil it out.
As we focus our investments across multiple molecules targets and rare diseases that meet our criteria, we are diversifying risk by adding to our options and discovery in early development.
Adding these options and increases are overall chances for success in achieving that goal of bringing additional products through registration and to patients.
Have you as you've seen.
We are also disciplined about decisions to invest in later stage products whichever forces proportionately more extensive.
We wanted to accelerate R&D spending for a pivotal program until we have clear data that we are likely to have a first in class or best in class molecule.
This is our approach with P. C X 10 zero 13.
We want to see data that shows VCX censor of 13 is an oral factor D inhibitor with once daily dosing excellent safety and efficacy if it is as good or better than the other options for patients.
If the data show VCX censor of searching has this profile is the profile of the best in class molecule and we will invest to run pivotal trials and bring it to market.
If the data show, we don't have a best in class molecule here will stop development.
It is early and there's still plenty of unknown. So it's B C X 10 zero 13 program, but we do have two updates to share with you today.
We have restarted dosing are multiple sending guys trial in healthy volunteers to add another dose level. We've previously evaluated multiple data sets up to 80 milligrams and also single doses of up to 110 milligrams, where we saw excellent durable control the alternative pathway at 24 hours <unk>.
These data to support proceeding with evaluation and patience.
Now, we will take our healthy volunteer dosing higher to refine our model a PK model dataset with daily dosing at 160 milligrams for 14 days.
This is in parallel to the work will do impatient to obtain more robust information for our P. K model and eventually inform pivotal final pivotal desk selection.
We are now also proceeding with our dose ranging trial VCX 10 zero 13 impatience.
We expect to didn't begin enrolling patients by the end of the year with initial data available next year.
We are conducting this trial and patience and we have chosen to work in P. N H for evaluation, if those alternative pathway activity and clinical outcomes to.
To determine if we have a safe effective once daily dose that meets our criteria to move forward into a pivotal program and renal complement mediated diseases like I G. A N.
Before P. C X turns your third or beyond P. C X 10, or 13, we continue to build in advance or early pipeline as we invest in discovery for new targets, where.
We're now ready to share our exciting progress with a growing pipeline of molecules and we look forward to doing this at our R&D day in November at the Biocryst Discovery Center of excellence in Birmingham, Alabama.
Now I'll turn the call over is Anthony.
Thanks Alan.
With global Orla day of revenue for Q2 coming in at $81 million, we solve a step up that we anticipated from Q1 based on the strong second quarter revenue performance and continuing underlying patient growth.
And similar to last year's quarterly cadence, we anticipate that revenues will increase slightly in the third and then again in the fourth quarter.
Your today's oil revenue is that over 149 million.
Would expect revenue in the second half to come in at approximately $171 million or an average of 85.5 over the next two quarters.
We're confident that we will achieve our revenue guidance of no less than $320 million for the year.
Confined or details second quarter financial than today's earnings press release, and I'd like to call your attention to a few items.
Total revenue for the quarter came in at $82.5 million $81 million of which came from Orlando of that $81 million of global Orla. Their revenue 72 point H came from U S sales with the remaining $8 $2 million coming from X U S increases of 24% and 26% over Q2 of 2022 respect.
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Operating expenses, not including non kind of stock compensation for the quarter were $94 million flat to Q2 of 2022.
R&D investment for the first half of 2023 reduced significantly compared to the same period of 2022, and we expect that trend to continue and that R&D investment in the second half of 2023 will be lower than in the second half of 2022, even as we factor in the additional trials for <unk> 13, but how long discussed and continued investment in our.
Pipeline that we won't share more about the R&D day in November .
We reiterate our full year opex guidance at $375 million for the year flat the prior year.
Cash at the end of the second quarter was at 415.7 million that includes net proceeds of $26 million from the Pharmacon refinancing that we closed in April a deal that moved our debt repayment repayment. The house into 2020 ice gave us greater access to capital and improved our terms net.
Net operating costs utilization for the quarter improved from $28 million in Q2 of 2022 to approximately $13 million last quarter, primarily driven by our increased revenues.
Earnings per share for the quarter were negative 40 cents that includes the impact of venom Proximately 29 million dollar debt extinguishment charge. Following the refined with Pharmacon adjusting this one time charge out on a pro forma basis earnings per share came in at approximately length negative 24 for the quarter.
With the continuing strong performance of <unk> as we move towards our $2023 no less than $320 million and onwards to peak sales of 1 billion.
Alpex flat to prior year, while continuing to invest in advancing our pipeline all combined with our strong capital position, we're in great financial shape to generate value as we move the company forward now I'll pass the Buck to drive.
Sydney So.
So we had a great quarter, whether it's the orla Dale performance or the advancing in the pipeline and that is a direct result of great execution and so I want to thank the biocryst employees for that we.
We plan to report Q3 earnings on November 2nd from Birmingham, The day before R&D day, and we are very excited to host some of you at our labs in Birmingham, Alabama, We've got limited space of the rest of you will be able to participate.
Via webcast. Some of you may be asking why are we holding this on a Friday afternoon in Alabama, and there's two main reasons. One we found that when you're there and have hands on seeing what we do and how we do it in meeting our scientists you have a better appreciation for what we're capable of doing.
And the second reason is Saturday the next day after for those of you who are college football fans are not there's a pretty important game down the road in Tuscaloosa, where L. S. U is coming to play Alabama. So we look forward to hosting our R&D day on November 3rd in Birmingham, Alabama, and that's it for our prepared remarks.
We're now going to open it up for your questions.
Thank you.
Well now begin the question and answer slash.
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Thank you Tony.
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Our first question comes from them has seen a mud bank of America. Please go ahead.
Hi, guys, good morning, and I'll start looking for flights to Alabama.
I wanted to maybe get a little bit of color I had you're thinking about the second half of the year for oil a day I know we're supposed to talk about things that you expect to see some growth and a third and fourth quarter I think people would be interested in knowing.
How your growth, which is very strong.
Uhm turn into outsized growth in coming years, then where do you.
Your area is that of you know real I'm not need now that you're you know thoroughly.
Mm mature instead this launch what are your focus areas bring your marketing team for example, and where do you think most of the upside is gonna be coming back.
Sure does easy I can I can take that.
So so first of all the the question about the second half of this year. So we expect the revenue too.
To go up in at the pace of are the additions of of patients on therapy. So as as I've talked about we've had really consistent growth in patients on therapy. So that that's what's going to drive the growth in Q3 and Q4 Justice is done since launch.
And as far as your question about the the unmet need the opportunity what we know is that the all things being equal the great majority of HIV patients would rather treat their disease with one pill once a day and so the unmet need is to get all the people who haven't tried yet to try or <unk> and a lot of.
Those are patients who are taking other prophylaxis therapies injectable prophylaxis. So we're going to keep focusing is our number one priority on giving them the chance to switch over and try orla Dio and seeing how much more they can benefit by treating their their disease with an oral drug.
Charlie.
When we were at the patient summit in Orlando.
One of the things that we had a challenge with at the launch was patient activation because of Covid and and what we heard from patients is this the first time. They were aware that it was approved and available to them and I think the more that we get going to zine I think that's the potential for continued growth, but the bottom line is there's a lot of good drugs out.
There there are people are controlled out and so it's tackling it doctor by Doctor patient by patient to get them to want to try it because if that works for them, it's way better than being injecting yourself.
Okay.
And you know you.
And your confidence in reaching a billion dollars.
You have a sense of.
How long it would take from where you are now to reach Dot com.
So so I think what we've said before and will say say again on this dizziness, you can draw a line between.
<unk> revenue of about $122 million to 50 last year and 320 of this year and that will give you a pretty good sense of when we expect to get 1 billion to $1 billion it'll take it will take some more years based on what John was talking about it's it's <unk>.
Moving this market takes a while but everything we've seen are forward looking market research as well as are the.
The results that we're putting on the board gives us great confidence that we're going to get there in that line crosses the ability and around the turn of the decade and remember we have patent protection up to 2039. So we've got almost another 10 years of protection at peak so.
Real value.
You're welcome.
Our next question comes from Greece.
Piper Sandler. Please go ahead.
Good morning. This is not a coca <unk>. Thanks for taking my question.
Maybe just around that Tang Oh, Terry King program. I know you guys are going to evaluate a higher both in hockey volunteers I guess, just any color around maybe how that translates to take care of some preclinical models by you observed a chronic taxes.
And then just to clarify I've got to have the chronic <unk> experiment been completed at that point.
Yeah. Good morning, So I would just hate those in reverse order.
In terms of the chronic talks we had a chronic talks program, it's still ongoing and we don't expect that to complete until later in the year.
In terms of the.
Information and translating that to affect what we really what we know is from healthy volunteers, where we see that the clinical.
Complement pathway is inhibited to greater than 97% at 110 milligrams and we need to go into patience and we'll do that with our patient trial M. P. N H to assess further information round compliment inhibition at that isn't and dose escalating as well as then how that translates into clinical ow.
<unk>, so that we can confirm the dose.
But I think at the end of the day Nicole It. It's it's all about what do we see in humans and.
And do we have a safe and effective dose that's once a day. So that's that's the whole point behind that trial.
Yep got it and then just really quick I know last credit there are some I mean typically I just had one quick the lack of funding comes from external charity, hoping to provide copay for patients on holiday I guess, where does that situation currently.
So the situation has stabilized so.
We are not losing more patients who are having patients having to drop back to free product.
Since the first quarter those that we did put on long term free product in the first quarter have to stay on it for the rest of this year, but but for now the situation is stabilized.
Make one for Charlie and his team despite that they are making great.
Attracts you are having great traction and converting patients from pre product to to pay it as he said it was at 34% and now it's down to 30, and my expectation I think Charlie's as well as that that's going to continue to go down.
Great. Thanks for the call.
Our next question comes from basic.
Calling please go ahead.
Thanks, so much for taking our questions. We have a few follow ups. So first regarding 10 13 additional cohort was this a request from the F D. A or just the next natural step in your development for this program.
And then regarding the potential range of services for the global Peanut study willing to provide some details there and I know he's disgusted and next year, but their potential to get a sense of the safety profile any earlier. So those are our questions on kind of a pipeline and then regarding or let down I know you've.
In the past not discussed exactly the <unk> the size of the sales force, but now that you've increased it. Thank you for could you just talk about the relative sizing prices other competitors like Decatur as you think about expanding uhm potential efforts and maybe can you settings and <unk> patience. Thanks, so much.
So you Wanna take the tens or 13 in Charlotte you can take the sales force.
So 10 13D, they dose that we're adding what.
The healthy volunteer trial, the hundred 60 milligrams that is it for our own purposes that is so that we can assess.
Mostly PK from that does level and those are the anti PK model will need that once we had our patient data in order to confirm the final days for pivotal trial initiation.
So that's that's why we're adding that.
At this level in terms of the range of doses and that we're looking in the P and each trial will be starting at 80 milligrams and dosing up from there. What we're looking for is compliment activity, we're looking for that to be.
Looking at that for multiple doses engine. The disease State. We're also looking men for clinical outcomes and we're trying to assess fend for safety, but more importantly for efficacy ink and that in the in the <unk> in the population said it will be in clinical outcomes like looking at hemoglobin L. C. H.
Helen it might be good to just talk about roughly how many patients do you think we need for that study to get a sense of that and how long do we need to follow those patients to get a sense of the safety at least in the short this initial study yeah.
So that's that's a small study and we don't need many patients and that's one of the reasons to assess our continent inhibitor and and patients with <unk> you can just escalate and we will be doing that within individual patients and each one will be giving us information on then how that patients confident system is affected and their own clinical outcomes and dose escalating with.
Outcome.
And then on the the the sizing of the Salesforce, what I've said before is that our teams between.
Right in the mid point between 30, and 50 people I've never said the exact number but.
The beginning of the year, we did add a few sales territories. The the biggest thing though that we did is double the number of our region. So that it gave a regional managers of regional directors more time to spend with their teams and with key customers.
When we build our sales force the number one thing we look at is the market potential in terms of.
H, a prescriber is out there and so we build it on a on a workload basis for each each.
Sales reps so they can be efficient, but we also do look at what the best we can tell what the competition is doing and we think that our team is sized very comparably to them and Charlie it's not just the rep right. What we hear from doctors that they see somebody from Biocryst every week until you might Wanna just talk about the whole team that.
Simultaneously what we do is we have we have a market access team out in the field. So we built up that team we've expanded our patient services team. So that they work closely with patients, but also with the practices and then of course on our medical side, we've got a very excellent medical team out there.
Working to educate physicians. So we look at the whole the whole package and as we do our yes, we we get feedback that that they're seeing biocryst people.
The most frequently.
And very helpful. Thank you.
Welcome.
Our next question comes from Brian Abraham RBC. Please go ahead.
Hi, everyone. This is nevin on for Brian .
Again on a good quarter, so I have a couple of questions about.
That you guys are taking to confer free drug.
Patients to pay drug can you talk about some of the efforts there in regards to patient education.
Simplification of some of the paperwork that's been mentioned in a previous call and.
And then also if you could speak to some of the gross to net friends of the quarter on some of the recovery too.
He's quarters as well.
Sure Yeah on the.
The conversion from free drug to paid drug the place where we've made the most progress is within the the commercially insured market, which is the largest portion of our business a little over 60%.
And the number one thing is you are alluding to is is making sure that we are working with customers to get all the complete paperwork. So what that means is for a new prescription coming in that the start form is complete we've got the lab tests, we've got the clinical background of justification, if we get that all complete up.
Front, the insurer is much more likely to to approve the claim.
Likewise anyone who has been on free drug going back and doing a really comprehensive appeal letter of medical necessity.
Putting in the whole patient and family history.
Is critical to the insurers changing their mind and as our team is more and more focused on this and helping educate health care providers in particular.
We're seeing more and more success in getting people moved over to paid product.
The growth to net.
Gross to net that's a part of what happens in the first quarter, where your revenue goes down a bit one of those factors is that we take it in on the commercial side with our co payment assistance program. The biggest <expletive> happens in Q1, where many patients and get up to the point of their out of pocket Maximums are exhausted.
And then that normalizes in Q2 and for the rest of the year. So gross to that was all.
Was as bad as it's ever gonna be in in Q1, and then it normalizes for the rest of the quarters.
Friend out of what we said in queue on it and thought it was not the higher end of about 15% to 20% range than we had expected that in Q2 would come in to the lower end of that range and then maintain that throughout the year and that's exactly what we saw happen.
Okay. Thank you and then if I could also ask about the retention rates of patients who are on the drug you had mentioned that the same number of patients who dropped off despite the higher up I guess the higher denominator there.
And so what do.
Are those retention rate and in regards to the retention rates are they kind of the same in the U S and X U S are you seeing any.
Different within what the.
Right foot like those geography.
Great question, So what we're seeing at this point and we've got Ah.
A lot of history now that gives us confidence and saying this is that the pattern of discontinuation is very consistent so when a patient starts in the U S. A patient starts on therapy about 60% of them make it to one year and then we lose very few people after a year and so what that means in in the U S.
Market is every month as we're getting a consistent number of patients coming onto product.
We we can predict how many people are going to drop off and our base is growing so the absolute discontinuation rate as a as a proportion of our base keeps going down X U S. We're seeing the same pattern of when people discontinue but actually the overall retention rate is has been <unk>.
Better.
We think a lot of that has to do with just the in Europe , you tend to have larger.
H a treatment centers, where the health care providers are very focused on their patients in and maybe be just generally providing better education overall the key to retention is and we're very focused on this is setting expectations with patients. So that they know what to expect in those few.
First few months of of therapy, and if they hit any bumps then they don't.
They don't panic and drop off therapy, and we've seen that has been very effective and I think that's why we've got this stable pattern that we're seeing now.
Okay. Thank you all.
Our next question comes from John .
Jn Securities. Please go ahead.
Hey, good morning, Thanks for taking the questions on the free drug dynamic Charlie you mentioned the goal to go to at least 20%.
Less on free drug I'm wondering when you think that could happen in better with the guidance for the second half of the year with steady revenues between three to four Q.
Should we expect any movement on the free drug status in the back half of the year of your speeding steady patient and steady revenue. It seems like that should that'd be stable, but whenever you talk a little bit about this to those two points.
Sure Yeah. So.
Kind of the the the second question Yeah, we expect to make just continued incremental progress in the second half of the year getting people to pay drug it will contribute but I think the patient growth is really what's going to drive.
Our sales growth the second half of the year.
As far as when do we expect to get to the 20% or better it's gonna take a few years to get there, but the early as we're really focused on this what we're seeing in the last few months is new patient starting.
Therapy are already getting too and 80% plus paid right and so that gives us that confidence that over time, we are going to be able to get everyone. There. So I think it's the team focusing our patient services team our market access team our sales team working to educate patients and healthcare providers.
About this and continue to work with Payors.
That all of that together is what's what's making the difference.
Got it and X as you mentioned things are going well wondering if we should expect to see an acceleration eight point affairs tipping point or that's gonna be.
Grind higher as well, there and maybe a little bit about if it's gonna be certain countries contributing the most or that's gonna be consistent geographic expansion driving the revenue X U S.
Yeah, I wouldn't expect.
Tipping point, our acceleration, we're really seeing the same pattern of patient growth.
Talked about it takes a good for patients X U S to add up to.
One U S patient just from a revenue perspective, we will keep AD. So the the steady patient growth is is the number one thing we'll keep adding countries. So we expect next year or two.
To launch in our wave to of of Europe , So countries, like Italy, and Spain and Benelux.
So we will have those.
Those continued additions to a revenue stream, but I wouldn't expect a big inflection point steady growth.
Thanks, I appreciate the call.
Our next question comes from Justin Kim Oppenheimer and Coke. Please go ahead.
Hi, good morning, Thanks for taking my question.
Maybe just a quick one first and then a commercial I just think about the additional data being a crude for P. N. H can you just describe how those results may inform I again, and whether you think the clinical bar might be lower in terms of the alternative pathway inhibition required perhaps due to the nature of these or competitive.
<unk>, Yeah, and then maybe on the commercial front Charlie could you just update us on the mix of growth you're observing.
Whether those patients being added are naive to prophylaxis or experiences as well as coming from high prescribers were Slovak prescribed thanks.
So on the piano each question.
That what we need to understand next is the dose that gets us.
Two efficacy so we're looking for a safe status that is effective and that's measured by both the effect on the compliments pathway and then the clinical outcomes.
Looking at that in P. N H because that is an excellent.
Opportunity to understand fairly quickly with a small number of patients whether we're getting too rigorous complement inhibition and the clinical outcomes that translate and we know what we need to see to demonstrate a dose that is achieving both we would expect that does tend to translate to other diseases and.
We're treating the PNA itch opportunity is one that we would assign we would achieve and understand the pivotal doesn't it take that into IGN and other diseases.
And we are as a reminder, we are looking for differentiated dragged to take forward, we're looking for safety and efficacy that's as good or better from what we're seeing in the field accomplishment and <unk> and we're looking at that with once daily dosing and Thats, what others have done in the field with alternative pathway inhibitors. So this is new ground.
And then on the patient and prescriber mixed Justin again. The story is is consistent patterns. So still fit about 50% of the patients are coming from other prophylaxis products and the other 50% at least best we can tell we're not recently on a prophylaxis product or.
We're completely appropriate naive so.
So it's great to see that consistency and then on the prescriber mix.
We get a little more than half of our prescriptions from those top 500 doctors that I've talked about the ones, who treat about 50% of the market and then we get a little less than half from the larger group of other physicians.
And what's great is that every quarter, we're seeing a very consistent number of new early day of prescribers being added. So we continue to go abroad. The prescriber market and then deeper within existing prescribers.
Okay, great. Thanks, so much.
Ladies and gentleman as a reminder, if you would like to ask a question. Please press star one.
<unk>.
Our next question comes from search Bellinger, New 10 minutes. Please.
Please go ahead.
Hi, good morning.
A lot of questions I'm Gonna ask at this point, so maybe a couple of around the <unk>.
A stomach that will tell recently, let me just talk about the the level of awareness bill within the patients that you met there whether you've seen.
You've experienced any kilwinning from attending the meeting.
Maybe some additional enrollment in a quick start program.
Yeah search.
John said earlier, we did.
First of all we had a we had a a big presence there and this was the first time attending.
Since we've launched Orla Dio and so we had a booth there we actually had two booths, both a branded an unbranded booth lot of patient traffic coming through our booth a lot of great conversations.
And.
It's it's always a little frustrating, but what a patient says Oh is this drug launched but we did hear that and so it's great now they know or what day. It was on the market and.
As we said 1200 patients and family members. They all left knowing that oil a day I was on the market. So what we're telling our health care providers out there is that this conference just happened and they may be getting patients coming in and asking different questions about their therapy in that or the day it was as.
Is that.
They may have questions about early Dale So we'll see if we get a tailwind, but it was definitely an important.
Milestone and it was just it was great to see the community again and just to to see their excitement.
Just them getting together again it was it was a really great meeting.
I think I think too it's it's.
It's like the first of what I hope will be a bunch of patient meetings regionally all that stuff stopped with COVID-19 and so a certain state a certain part of the country.
Gather and and I think the other thing is people reconnected, it's like watching a family reunion honestly and the word of mouth spread because we got an equal number of people that came up to him and it's like Oh My God Orla data has changed my life and let me explain to you why and so when they're talking to other patients about that I think that's gonna be helpful too and then.
The last piece was.
The Kols are there as well and it's just a different dynamic at a patient meeting then when you go to the college meeting are quite AI and so.
We were able to show up in a way that differentiates us maybe from our competition and and I think it's a chance to really reinforce and connect with the kols in a way that maybe is harder in other settings. So it it was fantastic.
Our next question comes from deep talked much even Barclays's. Please go ahead.
Sorry, I think this is.
Tony on for <unk>.
Quick question I'm kind of on 10 013, what what are they still data would want you know potentially further development and what could we may be expect to see R&D day on this already minutes other new pipeline assets.
Yeah, Okay. So.
With 10, 13, and what we are looking for something that's really.
Quite straightforward and I think will be quite clear when looking for data to show.
That we're seeing the activity levels, we need to see in the clinical outcomes that we're looking for in patients and we're looking for that in a manner. It's also safe. So it's a fairly simple we're looking for safety and efficacy that's as good or better than what is available to patients and we're looking for that then with once daily dosing once.
We see that and have selected the dose per pound program. That's the point at which we would be making the decision to further invest in in shape pivotal trials.
In terms of R&D day will update across pipeline. There we have a number of things that we've been working on and I'm really excited and pleased with what's been happening in the discovery in early programs in Birmingham and within the company. So it's it's sort of breath in depth.
Pipeline that we'll be discussing there yeah.
It'll be any new information on 10 zero 13 at that point this'll be stuff, you've not heard of before.
Our final question comes from.
Crossed with Jeffery. Please go ahead.
Hi, Good morning, this is <unk>.
Thanks for taking our questions congrats on a good quarter.
I guess, our first question is on the.
The Q2 revenue growth, you're you're saying for the rest of the year. The revenue growth is going to be more steady front last year. We saw there was a bit of confounding factor.
<unk> the fourth of July holiday ordering that affected.
The relative growth rate of Q3 on queue for how should we think about the effects of this year.
Yes, so Q3, and Q4 will not be as big eyed.
Jump in revenue is cute too because Q2 was driven by the patient growth, but also the all the factors coming out of the Q1 reauthorization process. So it's Anthony described in his comments.
We should average about $85 five for the little.
A little bit less than that in Q3, a little bit more in queue for to get to the to the 320.
Of shipments that came into June .
That was part of our expectation this year, we saw that happened last year and so we built that into our plan.
And just as a reminder for everyone in the U S. We have a sole source specialty pharmacy. So this is all based on individual patient demand and there are a lot of those patients going away for the fourth of July holiday and so around times like that you will see a little bit of a pull forward, but it's usually just a day or two if shipments.
I see maybe it's just a quick one on C. One normal patients we saw.
Some data on on a day I was successfully managing C. One normal patients early this year and Yahtzee I'm just wondering if you're sharing any insights into how you are seeing your real world how patients with C. One normal profile.
Like how many of them are on the therapy.
If you see anything about retention rate and et cetera.
Thanks, Yeah, we haven't.
The the the number other than what you saw on their yoki.
Poster in terms of the proportion of our business, but we do get seen one normal patience I think all the prophylaxis products are seeing C. One normal patients. These are patients who have really struggled.
For a number of years, it's been you know their diagnosis isn't as clear cut as type one and type two and so they've they've they've looked for therapies that work and what we're seeing for a lot of them is that oil a day O is really helping them and so we're seeing consistent reduction in attack rates and.
Patient reported attack rates and then from our retention perspective, we're seeing just about as good retention with C. One normal patients as we are with type one and type two patients and so.
We.
You can expect more data from us on this in the in the future.
But right now what we're seeing as it.
We're very pleased I'm just glad that we can we can help these patients.
Got it thanks, so much congrats again.
Okay.
Our question and answer session and just at the conference has now concluded. Thank you for attaining today's presentation you may now disconnect.
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