Q1 2022 Insmed Inc Earnings Call
In early 2023 for the Phase III <unk> study.
The second meeting of the DSM V. For this trial was held in March and it was again recommended that the Aspen trial continue as planned.
When we look to the market size in bronchiectasis, we see that it is a very substantial opportunity at.
At the time of potential launch, we will be targeting a patient population that aligns with the patient population, we're studying in Aspen further.
Further our commercial preparations for <unk> dovetail off the infrastructure, we have already built for aerospace.
For our cystic fibrosis program the phase III PK PD study continues to progress as planned and we look forward to sharing top line data later this year or early 2023.
In line with our strategy of building building, an anti inflammatory portfolio harnessing the DPP one inhibition pathway. We recently announced that we are advancing development of Brent So cats it into two additional indications, which we believe represents substantial potential market opportunities.
The first is chronic rhinosinusitis without nasal polyps or Crs.
As a reminder, crs without nasal polyps, which we are targeting generally involves more neutrophil recruitment in the inflammatory process versus crs with nasal polyps.
Currently there are no approved treatments for the approximately 26 million patients with Crs without polyps in the U S.
We will be targeting patients with severe disease characterized by eligibility for endoscopic sinus surgery.
Each year in the U S. Approximately 155000 patients undergo surgery for Crs without nasal polyps of those approximately 15% or 23000 patients require a revision or repeat surgery.
The second indication is hydro and that is super tivo or Hs for which the only approved therapy is humira.
We believe a well tolerated once a day oral therapies, such as <unk> would be a welcome addition to the treatment armamentarium.
We anticipate that success in these four indications bronchiectasis cystic fibrosis, Crs without nasal polyps and Hs could position <unk> as a leading anti inflammatory therapy for neutrophil driven diseases.
Our third pillar TPI P. A dry powder formulation of <unk> for the treatment of pulmonary hypertension is in three parallel phase II trials, the phase Iia trial evaluating <unk> for the treatment of PIH is currently underway.
We plan to share preliminary data from a small number of patients over the course of this year.
As a reminder, this study is not gating to the other phase two trials for TPI P.
These are the phase III <unk> trial in ph and the phase II trial in ph ILD, both of which are currently active and recruiting patients. We look forward to providing updates for these three trials throughout the year.
Finally, our fourth pillar translational medicine, which encompasses a wide range of innovative technologies and modalities, including gene therapy gene editing protein D immunization and manufacturing capabilities.
This platform, we plan to file at least one IND per year.
Preclinical work in our two most advanced indications continues to look very encouraging.
Upon completion of these studies, we will look to provide a comprehensive update of our translational medicine work and its anticipated next steps.
Turning to the upcoming American Thoracic Society conference or Etfs, taking place later this month, we will have a number of presentations across three of our pillars at Ats and I'd like to highlight two of those for you now.
The first of these is a retrospective cohort study of <unk> patients demonstrating reduction in hospitalizations after initiating <unk> treatment.
Another noteworthy presentation provides a post hoc analysis of the phase II Willow study assessing the number needed to treat and the number needed to harm, indicating a favorable benefit risk profile for Brent sarcasm and non cystic fibrosis bronchiectasis.
In closing <unk> is in a period of execution in our late stage pipeline alongside our commercial franchise.
Broadly we are keenly aware that these are the most challenging biotech market conditions seen in our lifetime, which we anticipate will persist throughout the year.
However, <unk> is in the enviable position of having the resources to see through the current market conditions and beyond.
We are a revenue generating company that benefits from a rich late stage pipeline and a strong cash position to support further development.
And with that let me now turn the call over to Sarah.
Thank you al and good morning, everyone.
We ended the first quarter in a position of financial strength that we believe will continue to support the four pillars of our business.
Earlier today, we issued a press release with our detailed first quarter finance cortisol all of which fall in line with our internal expectations.
Let me highlight a few of those yourself screen now.
As reported this morning, we ended the quarter with $664 $7 million in cash and cash equivalents and marketable securities.
Distant with our earlier guidance, we anticipate this cash position will support our ongoing business into 2024.
Total net revenue for aerospace was $53 $1 million for the first quarter of 2022.
We are encouraged by strong first quarter sales, which showed a 32% increase compared to first quarter 2021 performance. Despite significant unfavorable exchange rates in both Japan and Europe .
On a regional basis net revenue in the first quarter with $40 $8 million in the U S.
$10 $7 million in Japan, and $1 $6 million in Europe and rest of world.
Of our three key regions, Japan, and Europe are hit the hardest as a result of OMA product, but we remain excited for what the rest of the year may bring as those territories continue to emerge from the pandemic.
In Japan, specifically, we look forward to the list of the two week dispensing limit in June which should lead to a more affordable co pay for patients.
Despite the mixed trends worldwide, we reiterate our guidance of at least 30% revenue growth on a global basis. This year.
Let me now touch on a few financial highlights from the quarter.
Our gross to nets in the U S for the first quarter of 2022 were approximately 16, 6%.
Recall that the gross to net in the first quarter of each year are typically the highest and this is in line with what we have seen historically with higher cost treatments for rare diseases.
We are reiterating our previous guidance of U S gross to nets to be in the mid teens for 2022, which is consistent with prior years.
Cost of product revenues for the first quarter of 2022 with $12 $2 million or 23% of revenues, which on a percentage basis is consistent with prior periods.
Turning to our GAAP operating expenses.
In the first quarter of 2020 to research and development expenses were $84 $4 million and SG&A expenses were $56 $7 million.
These expense levels reflect the continued support of our four pillars, including seven ongoing clinical trials in our pipeline and the commercial infrastructure to support are key in our three key geographies.
Importantly, I'm pleased to note that we had a slightly lower cash burn level in the first quarter of this year compared to the first quarter of 2021, a decrease that speak to our careful evaluation of spend levels, especially in this difficult biotech market.
In closing in Smith finished the first quarter of 2022, and a position of financial strength that supports continued execution across our commercial business clinical pipeline and early stage research.
I'll now turn the call back to Bill for closing remarks.
Thank you Sarah.
Smith continues to deliver against our strategic objectives, we have an exciting future on the horizon and the remainder of 2022 will be an extremely important execution period across our programs. The catalyst for all of this work is our vigilant pursuit to create medicines that have a meaningful positive impact on patients' lives.
I'd like to extend a thank you to the entire intimate team as well as the patients and caregivers who participated in our studies and with that I'd like to open the call to questions. Operator can we take the first question. Please.
Of course, thank you very much if anyone would like to ask a question. Please press star followed by one on your telephone keypad. If you would like to withdraw. Your question. Please press star followed by T. When per pound to ask a question. Please ensure you Amit lately.
Kindly ask two questions after which you may rejoin the queue.
That stuff slipped by one to register a question.
Our first question is from.
Jessica Fye from J P. Morgan Jessica Youre line is open. Please go ahead.
Hey, guys. Good morning, Thanks for taking my questions are first one is about Eric Keith I was hoping you could just characterize the extent to which you see COVID-19 still affecting your business in the U S and in Japan, and the rest of the year and just kind of compare and contrast that relative to the first quarter.
<unk> of this year.
And then second question is with this phase <unk> study for TPI P. In ph in the phase two for ph ILD is there any chance we could see data from either of those in 2023.
Thanks, Jessica first question, Eric is I would say.
Covid was certainly evident in the first quarter, especially in Japan, and Europe . The omicron variant to put a finer point on it was very severe in Japan much more so than for example, Delta was here in the U S and that is both in terms of hospitalization and death rates et cetera, and the although we're on that.
<unk> now significantly.
That a return to normal has been slower than it was in the aftermath of the omicron retreat in the U S. That's probably because the booster rate in Japan was about 7% in January it was quite low.
But as we've moved through that I think we started to see some.
To steal a phrase green shoots.
And the Best example of that was the Japanese respiratory society, which just took place about a week ago or so and it was actually held in person and we had a tremendous <unk>.
<unk> of interest and support at that conference. So I'm I'm bullish about Japan for the balance of the year, particularly after June when the two week restriction on prescriptions gets lifted I'm hopeful that we won't see a resurgence of another variance in any of the territories.
Hoping that omicron as the last stand if you will.
And if that's the case I would expect.
Everywhere to improve but it was also quite severe in Europe , I would say and Thats still dragging on now.
The US is by contrast, much more open I'd say, we're probably 80% of the way there.
Our best guess.
And I would expect in contrast to last year, where we saw ebbs and flows of different variance, even if we were to see some omicron.
<unk>. Unlike variant return in some of these territories I think the attitude of everybody has changed a lot people are going to find a way to work through whatever is.
<unk>.
Presenting itself unless we go back to lockdown because the key to this in the end of the day is not whether people are infected with COVID-19, it's whether theyre being hospitalized because it's the hospitalization that blocks the onboarding of patients in Japan. Its the hospitalization in the U S that ties up the physicians, who would otherwise be able.
To prescribed to patients.
I think the only lingering effect of COVID-19 throughout the year and we're hopeful that the labor market will repair is actually the availability of health care personnel. There was a real downdraft in the U S. In that regard and I would say the picture there is better on the commercial front than it is on the clinical trial front the challenges on the clinical.
Trial front are largely due to staffing around.
Centres and people that are involved in clinical trial enrollment.
I would say the commercial side that the treatment of patients is in much better place. So hopefully that detail is helpful.
With regard to the <unk>.
P J H trials.
So it takes a while to enroll them to be in the phase two in ph ILD.
But as soon as we get a sense of what the tempo for that is we'll update it but that is not distinct to us it youll see that across the board in any ph trial setting.
Thank you.
Yeah.
Thank you. Our next question is from Andrea <unk> from Goldman Sachs. Andrea Your line is open. Please go ahead.
Hey, everyone. Thanks for taking my question. My first one is a follow up question on Erra case in Japan.
Strong performance here, despite the Covid and FX headwinds and you've spoken about this lift of the TUI dispensing one that Thats coming post June just wondering if you can provide more color here just how quickly do you expect that to translate to sales is it pretty immediate or should we expect a lag before physicians really change how they prescribe the drug and then I have a follow up question.
Yeah, no. So I think on that particular issue related to the two week Lyft.
It's always hard to know what kind of a response youll get but just to clarify this right now patients have to go back every two weeks. This is true for every new drug in Japan.
In the first calendar year, they have to get their prescription two weeks at a time, that's because of <unk>.
Instinct to want to watch very carefully the safety profile of any new drug arriving in Japan.
After the first calendar year that two week restriction is lifted and so for example, our patients could get a more typical three month allocation of medication and a prescription and they pay a co pay every time they return to get a prescription filled so you go from getting two weeks' worth of product to getting perhaps three months worth of product. It's a.
Tangible savings to these people.
And that I think will generate.
Less resistance to to Onboarding of new patients. So we would expect to see.
Response from that and I would expect it to be immediate.
Got it and then just as you look to the emerging data for aerospace, including the hospitalization production data that you're presenting at the upcoming Ats meeting how does that shape in any way. How you can go out and market the product to Pulmonologists is I guess, maybe if you could speak how meaningful that endpoint is compared to Sweden.
Very generous exacerbation rate.
Well I think.
And what we want to do is obviously speak our commercial effort will speak to the label and the label alone, but these kinds of data that get into circulation through conferences at places like Etfs them. Later this year at European respiratory Society as I mentioned about a week ago Japanese respiratory society. These are forums, where this kind of information gets <unk>.
Changed physicians talk about what is best practice and this.
Information that we're putting out there that really gets at the heart of what does your patient get for going through the treatment cycle, they're going to get at the data and label suggest culture conversion as a potential outcome. This suggest further that they may be able to reduce hospitalization should they.
Successful treatment and that is really quite a compelling argument to be made as you know we are already included in the global guidelines in the U S Europe , and Japan with a recommendation of a strong recommendation for the use of Erra case for refractory patients. So this just augments that argument with another tangible.
<unk> is a benefit to patients.
Great. Thanks, guys.
Thank you. Our next question comes from Jeff Hung from Morgan Stanley Jeff. Your line is open. Please go ahead.
Thanks for taking my questions for the TPI Pea Phase Iia study you remain on track to share preliminary data. This year have any patient has gone through the 24 hour monitoring or do you have better visibility on when that might start and then when you say a small number of patients. The study was already going to be in a relatively limited number of patients. So with the preliminary data being a subset of the patients you plan to enroll.
Yes, I appreciate that and I'm, just going to be very transparent with everybody. This is an incredibly frustrating study for us because we think the information will be quite valuable at the same time, we probably almost certainly underestimated the demand it puts on patients.
And on physicians in the context of executing against this protocol. This is for everyone's education, a 24 hour right heart catheterization of a ph patients in an ICU setting, where we administer a single dose of our drug and then track the impact on pulmonary vascular resistance through our various measurements across.
Of course that 24 hour timeframe.
We're hoping to establish is that there will be a reduction in pulmonary vascular resistance that will occur and we will remain and if that does happen. Although no. One has ever done a study like this before we think it ties directly to the preclinical animal data, where we showed that by accomplishing that you resulted in disease modification and Thats really the Daisy chain.
Link that we're after year, how many patients do we have to secure in order to establish that link I think that's a little bit.
Qualitative judgment, what we're trying to do is get enough said, there is credibility and the assertion that that PBR reduction and its sustainability is established once that is taken place I think this trial will have served its purpose. What we're doing right now is concentrating on trying to get the appropriate patients who are not only.
[noise] willing to undergo this procedure, but at sites that are now <unk>.
Free and clear of other demands related to Covid and that needle has been very difficult for us to thread.
I don't think that this is manifest in any of our other clinical trials just to be crystal clear, we have executed extremely well on Brexit CASM in the aerospace trials, but this one has been a challenge and will remain so I suspect. So we're a little hesitant to give any more clarity on this until actually we have the data in hand, I think perhaps a handful.
<unk>, two or three patients would be enough for us to present data to the outside world, but we're going to kind of make that judgment once we get to the other side of it.
Hope that helps.
Yes.
Yes.
Okay.
Thank you. Our next question is from Ritu <unk> from Cowen. Your line is open. Please go ahead.
Hi, guys.
Good morning, Thanks for taking the question.
Go ahead to start with my usual, how our Aspen event rates.
And also.
How how has conduct of Aspen arise.
And that's basically been affected.
Hi.
The war in Ukraine, and what have you seen.
As far as enrollment rates eastern European.
Bradley.
Bradley.
And whether you have specific sites in Ukraine.
It's pretty steady.
Sure. So let me just.
Start at the back end first Eastern Europe was one of our earliest regions that was enrolling in these trials and we have capped now eastern Europe because of the significant number of patients that we were able to enroll early on that's not in any way disrupted.
By what's going on in Ukraine, Ukraine is an absolute tragedy and I could.
<unk> for a long time on my thoughts surrounding this I will simply tell you that out of respect for those patients we have effectively set them aside from this study and replace.
Used additional patient counts elsewhere.
To ensure that we have the adequate powering that's consistent with guidance from FDA and our interactions there so.
People in Ukraine, and have better things to do right. Now then worried about participating or following up on a clinical study we had just to be specific.
Almost a dozen sites across Ukraine. There were 44 patients we had enrolled of so it's a small number.
We had none in Russia for any of our clinical trials and for Ukraine. It was only in Aspen in those 44 patients and as I said they are already accounted for and that will not have any impact on our timelines.
With respect to Aspen event rates, they continue to track as expected and consistent with the Willow study. So we consider that a positive and to refresh everyone's recollection, we examine event rates on a blend a blinded basis on.
On a very regular basis inside the company and at a country level. So we are tracking this worldwide to assess whether or not.
The surge or abatement of Covid has had any impact on event rates and I would say we are in a very good position with regard to that.
Information, albeit on a blended basis.
Got it in a very quick follow up.
The turnover to six month prescriptions in Japan.
Automatic or is there anything that could delay the compression.
That's automatic it'll happen in June got it.
Got it thank you.
Thank you. Our next question is from Judah Frommer from Credit Suisse. J. Your line is open. Please go ahead.
Yeah, Hi, guys. Thanks for taking the questions a couple of financial ones first.
You did hit that 30% sales growth guidance in Q1, with what sounds like maybe a more intense COVID-19 environment than anticipated. So just curious if kind of the COVID-19 impact was in line with expectations in Q1, and as that subsides. What would you say that perhaps COVID-19 is receding quicker than you anticipated for this year.
Yes.
Sure I'm happy to address that thanks for the question.
And so we were we were encouraged by our Q1 performance.
32% increase quarter over year over year quarter over quarter. So we were very pleased with that performance and gives us continued confidence in our global 30% growth on an annual basis.
And as will mentioned earlier Covid has impacted Europe , and Japan, the toughest in the hardest in Q1 because of overcrowding in the challenge is there less so in the U S and.
And we continue.
Look to build on that momentum that we've seen in the U S. EMEA abating of Colgate in both Europe and Japan.
Okay. Thanks, and then just on the cash runway guidance.
Does that anticipate the launch of another drug or indication or is there anything you can give us on kind of whats contemplated within.
Kind of building the organization up into 'twenty four in that runway.
Yes.
<unk> into 'twenty 'twenty four is based on our ongoing programs today. So it does not contemplate additional work to begin and we feel.
Very encouraged with our cask guidance $665 million roughly on the balance sheet.
And we've been very diligent on capital expenditures and where we allocate funds and as we think about sort of the next indications for brand. So we're being smart on sort of gaining additional activities.
As we think about those new indications, we think they are valuable and the right thing to do from an overall franchise perspective, and just balancing the capital deployment options of.
Of those programs.
Thanks.
Yeah.
Thank you. Our next question is from Stephen Willey from Stifel. Steven Your line is open. Please go ahead.
Yes, thanks for taking the question maybe.
Maybe one on the aerospace business and then just a quick follow up so I.
I guess in the U S. It's good it's good to see almost 10% year over year growth.
Is there anything that you can say about just your confidence at this point and potentially seeing.
A normalization of new patient starts and maybe a return to levels that were observed.
Observed in the first five six quarters post launch.
Yes. So I appreciate the question I mean, I think what I would say about where we are is that.
The first quarter, we did see some COVID-19 omicron effect in the U S, particularly at the beginning of the quarter I would say that the early signs as we exited February and got into March. We're certainly positive trend wise and my expectation is that that will continue.
Yeah.
A little bit hyped up because we finished our national meeting this week.
Here in New Jersey, and so we had the entire commercial team in house and.
And I think things look good for the year I mean, that's where our guidance came from that's why we're reiterating it today I think the U S is going to be put in a good performance and that's my expectation.
I think Europe will continue to be challenged the good news is in that sense Europe has a relatively small number of refractory patients 1400.
They are doing.
Very well.
The opportunity that's there in that.
Expectation of challenge is consistent with the guidance that we've provided Japan is really a more substantial opportunity than anywhere else in terms of the number of patients and I think early signs there are positive.
Basement of Covid Omicron variant in Japan is slower than expected, but we still as people have observed put in a good performance in the first quarter and my expectation is that as that gradually receipts and the enthusiasm from something like <unk> in the two week restriction lips, Japan Im hope, hoping will accelerate.
Through the year.
Okay, and then maybe just a quick follow up for Sarah.
Saw a pretty meaningful.
Sequential SG&A spend during the quarter and just.
Just wondering if this is.
Our Q1 specific reduction or if this is a lever that you're actively pulling on the on the Opex front right now.
Yes, no. Thanks for the question. So we continue to look at how can we be most efficient with our capital deployment. So you will see sort of ebbs and flows in some.
Lumpiness in some of our some of our expenditures.
<unk> keenly look at where can we.
Reduce expenses invest in the future investing development, while still ensuring that our commercial business has the.
Has the fuel.
So I wouldn't I wouldn't read into sort of the lumpiness of SG&A are our infrastructure is built and all three of our regions to support R. R.
Our launch in both Japan, and Europe , as well as the U S.
Yes, Youll continue to see those levels of expenditures.
Great. Thanks for taking the questions.
Yeah.
Thank you. Our next question is from Joseph Schwartz from SBB Securities. Joseph Your line is open. Please go ahead.
Thanks very much.
A couple of questions on Brexit.
We've heard some K well say that the rate of bronchiectasis exacerbations can be somewhat variable within patients individual patients over time and the rate of exacerbations was not stat Sig in willow due to some.
Frequent exacerbated I think I've heard you say so I was wondering whether you're blinded view of the event rate in Aspen you referred to before now.
Now suggests that this is not happening now and also weather.
Did you see those frequent exacerbations.
In the trial.
Hayes.
In ways before the trial that you could use now and enrolling them.
Aspen to prevent any such artifacts from happening.
Now in the next study.
And so this is a really important point.
The key to success in any bronchiectasis trials as we've learned from the many precedent trials that have not been successful is to have an adequate event rates to determine whether or not your medicine is actually having an impact on that very important measure as everyone knows we actually conducted that measurement process during the phase II Willow study.
Which many have characterized as kind of a mini phase III because it was 256 patients had actually looked at the clinically relevant endpoint of time to first pulmonary exacerbation and frequency of pulmonary exacerbation and at the 10 milligram dose we were stat Sig on both of those measures at the 25 milligram dose we were stat Sig on the primary end.
Point.
And trending on the on the secondary that overall was a very strong performance because it showed a 40% reduction so when we think about replicating that for phase III.
Adhere to some of the same entry criteria that gave us that opportunity to reveal that performance. The first is that we have moderate to severe patients in the study characterized as those who have had two or more exacerbations in the last 12 months. So the idiosyncrasies that surround patient and their variability with regard to <unk>.
<unk> patients is controlled for by ensuring that these are patients that have regular exacerbations importantly, the definition of a new get an exacerbation is also quite strict it isn't just the patient characterizing. It. It is also the physician who has to agree and change the treatment paradigm for that patient.
Neither by virtue of hospitalization or changing out medications. So it's quite a high hurdle to say that the patient has had an exacerbation.
That means that the patients were getting into the study or those who are going to continue to exacerbate. We saw that in the phase II study, we expect to see it in phase III and Thats why we track the blinded blended event rate across the study and compare it to willow to ensure that we're seeing consistency and indeed that is the case, so I feel very good about the <unk>.
<unk> rate profile of this study and the way we are proceeding and.
The issue of the 25 milligram arm in the phase II study, having a handful and I think it was only two or three hyper exacerbating patients, but these were patients that had.
As many as six exacerbations in as little as six months skewing a little bit the results.
We control for that in phase III by stratify.
So that shouldnt be an issue both that stratification adjustment and the fact that we are going to be enrolling more than 1600 patients in the phase III study should give us the best possible controls around these important variables.
That's really helpful. Thank you will and you have to know.
Both of my questions. There so I'll hop back in the queue. Thanks, Okay. Thanks.
Thank you. Our next question is from Anita Dushyanth from Bernbach Anita Your line is open. Please go ahead.
Hi, good morning, Thanks for taking my questions I have two here.
Could you Keith talk about the size of the team in Japan that is currently down.
If you have any plans to do that.
And that going forward now that you see.
<unk>.
Think of the pandemic.
And then the next question is.
Yeah.
Alright, thank you.
And then as you.
Again in some that are you seeing any.
Additional stigma that.
But maybe Mike.
Into the Encore study thank you.
Sure I appreciate those questions with regard to the size of the effort in Japan, we have roughly the equivalent of 20 sales reps.
Our therapeutic specialists in the field in Japan right now.
That gives us access to all of the primary areas, we want to call on at the time of launch of courseware dynamic as we move through and find success in Japan, and we will always consider augmenting that should we feel that there is.
I had a quick demand in the business model.
For investing in those additional resources and we would communicate that.
Should that should that take place, but that's something we're always looking at right now I think we feel really good about the 20 that we have they're doing a great job and we want to see that play out, particularly as we get through this two week changeover.
On the issue of arise in any insights we're gaining there you know it's a little too early to say I think one thing that can be said, though is that arise is going to provide a wealth of information and data and it will be interesting to see.
What we've learned from that study, yes, the topline very straightforward issue of did the patients culture convert how do they respond as measured by the <unk>, but even within that I think we're going to learn lots of details and trends that we're going to want to reflect on is oncor continues to move forward and were designed to do.
That so that we can adjust as needed and encore based on what we learned from arise. So I'd say those studies are moving forward.
In a time sense.
Relative to one another exactly as we want we preferentially enroll in <unk> two to one over oncor, we think that probably will mean that we'll see some acceleration in the enrollment of encore once arises completed because of that difference in enrollment priority and because encore frankly as a more attractive study for patients.
And physicians because it runs for a full 12 months of treatment, whereas arise is only six months and for these patients that want to be treated and are symptomatic in the frontline setting.
Short term timeframe of treatment upfront is can be a little discouraging to them. So I think we will get through the arise enrollment and we will see some pickup in oncor enrollment in the aftermath of that.
Thanks, Doug.
Uh huh.
Thank you before we take our next question I'd, just like to remind everyone. If you would like to register a question. Please press star followed by one on your telephone keypad.
Our next question is from Jennifer <unk> from Cantor Fitzgerald to Jennifer Your line is open. Please go ahead.
Hey, Thanks for taking my question. My first question is for Eric case, I know the plus 30% guidance is intact, but do you still expect growth in all regions, specifically for Europe I know, that's the smallest market, but wondering what the latest thoughts are there and maybe what your expectations are for additional reimbursement.
Opportunities.
Yes, I think the answer to that question as we've thought about the overall guidance. We wanted to put it on a global basis. Certainly we are looking for each one of these regions to perform.
Without taking anything away from the incredible efforts are being made in Europe . It is relatively speaking by far and away the smallest region in terms of addressable market and opportunity set and.
And there is no doubt that there are reimbursement headwinds in Europe across Europe , because of the cost of Covid and obviously some of the other distractions that region is dealing with at the moment I think thats put pressure on health care authorities generally and as I've said previously on a number of occasions, we think thats going to continue and probably intensify.
Not just for us, but for all companies, who have rare disease products in Europe , I would say for US. It's been mixed we've had some very good successes and some that are more challenged but overall I think our guidance continues to support be supported by what we see in Europe I'm not concerned about what's going on in Europe as it.
It relates to our guidance and I would expect.
Next regions, we're going to hear about are going to be from places like Belgium in England, then subsequently, Italy and France. There are some very positive signs within those areas and places like France, where we've had support from the ATM program on an ongoing basis, there's clear recognition of the value of this therapy.
I'm immensely proud of the effort and the ability to help patients in some of these regions through these specialized programs that they've made available.
To patients and to intimate so.
I'd say the picture in Europe , because of these pricing over pressures is mixed but it's a minor part of our overall revenue profile, we are very comfortable with at least 30% guidance.
And we will hope for the best from here.
Okay. That's helpful and maybe one more for Eric case, I think you've commented on this before but does that guidance.
They have flexibility to to remain intact, even if we see a fall or winter resurgence.
Covid.
So the honest answer that question is it depends on the resurgence.
And I think while we're all aware that that could happen I think the key to understanding its impact on our overall opportunity set as I've as I sort of alluded to a little bit earlier is this idea of hospitalization. So I wouldn't look so much to the infection rate I would look to the hospitalization rates because the hospitalization.
As were the practical blocks begin in.
In the different regions in Japan, they often hospitalized these patients as they're on boarded that's just a common practice over there and so when beds or set aside to treat COVID-19 patients. It makes it very difficult to onboard as many patients as easily in the U S.
When patients are hospitalized in large numbers it puts incredible strain on the staff and on the positions and it makes it difficult for them to see and initiate new parent new patients on therapy, I think what has been universal in the U S and in Japan as we've gone through this time frame is that notwithstanding those hospitalizations patients who are already.
On medication tend to be able to stay on medication. So notwithstanding what we saw in Japan in the first quarter, we did not see any impact on patients remaining on drug which was very encouraging and consistent with what we've seen in the U S. In the past so as we get to the fall, we'll see what we're facing but my guess is that unless you see a spike in <unk>.
Hospitalizations and calls for Lockdown.
That we should be able to find our way through that and navigate successfully.
Okay. That's very helpful. Thanks again guys.
Thank you very much with that that concludes our Q&A. So I'll hand back over to will Lewis for any closing remarks.
Thanks, everyone and have a great day.
Thank you everyone for joining today's call you may now disconnect your lines and have a lovely day.
Yeah.