Ladies and gentlemen, thank you for standing by, and welcome to the BioCryst 4th Quarter 2020 Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mr. John Bluth With BioCryst, you may begin.
Thanks, Daphne. Good morning, and welcome to BioCryst's 4th quarter 2020 corporate update and financial results Conference Call. Today's press release is available on our website. Participating with me today are CEO, John Stonehouse CFO, Anthony Doyle Chief Medical Officer, Doctor. Bill Sheridan Chief Business Officer, Megan Snisinski and Chief Commercial Officer, Charlie Geyer.
Following our remarks, we will answer your questions. Before we begin, please note that today's conference call will contain forward looking statements, including those statements regarding future results, Unaudited and forward looking financial information as well as the company's future performance and or achievements. 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. 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.
I'd now like to turn the call over to John Stonehouse.
Thanks, John. Good morning to all of you and thanks for joining us. Meaningful value is created by companies that translate great science into clinical benefit, Leading to approvals and successful market launches of new medicines that patients are waiting for. And the most successful biotech Companies are able to repeat this process of discovery, development and commercialization across multiple drugs In multiple disease areas, building this capability doesn't happen overnight. But when you make this transformation, you see real change and real value.
That transformation is happening right now at BioCryst. We know patients with rare diseases Are waiting for oral treatments despite having injectable therapy to manage their disease. We've heard that for years in HAE and are hearing the same thing in PNH. We have built an exceptional drug discovery platform to go after challenging targets like kalacrine inhibitors, Factor D inhibitors and ALK2 inhibitors, so that we can take this great science, get drug approvals and finally to the market to put an end to the patients waiting.
The approval of Orla Deo
in the U. S. And Japan is evidence of this change. Charlie and Megan will describe what we are doing and what we are hearing from customers in the marketplace. And while it's early days in the U.
S. Launch, they will share why we believe we're off to a good start. Megan will then share with you the even bigger unmet need in Japan for patients suffering from HAE and how ORILIDEO can have a big impact as the first approved treatment for preventing attacks. We believe Orlodeo has the potential to generate north of $500,000,000 in global peak sales. Next up is European approval.
We expect that approval in Q2 and Charlie will describe how his team in Europe has been preparing for the launch so we can hit the ground running just like we have in the U. S. We also have an increasing body of evidence that we can repeat this success and complement mediated diseases with our oral Factor D inhibitor. Last year, we shared proof of concept data in For PNH patients treated with BCX9930. Bill will update you on the progress of the study And what to expect when we announce the data from a full set of 16 patients, including both treatment naive patients And C5 inadequate responders.
What makes our oral Factor D program even more valuable and exciting As we plan to go after many complement mediated rare diseases, having one molecule to go after many indications could enable us to have several different approvals For many more patients. And finally, you can see the change in our balance sheet. As you will hear from Anthony, capital from our December financing has transformed our company and allows us to put our head down to So this transformation is no longer aspirational. It's happening right now, and we're focused on going fast because we know patients are waiting. Now I'll turn the call over to Charlie to share early insights into our launch.
Charlie?
Thanks, John. We invested early to be ready for a fast launch, To get patients on therapy quickly and to secure reimbursement access for Orlandeo, what we're seeing so far is very encouraging. We are wrapping up clinical trial conversions and the great majority of these patients are choosing to continue with ORILODEA. We are also seeing strong early demand from new patients. So far, patients on therapy are equally split between clinical conversions and those new to Orlydeo And our sales and marketing efforts are filling the funnel quickly.
What's notable is we are also seeing as many new patients switching to Orlodeo from injectable prophy products as those starting prophy on Orlodeo after previously treating their HAE with only acute medications. This is right in line with our strategy because we believe ORILIDEO offers significant and sustained attack with a reduced burden of treatment regardless of a patient's background therapy or attack rate. More early evidence that we're off to a good start in addressing the strong pent up demand is that HAE treaters are embracing Orlodeo. We have significantly expanded the prescriber base beyond those involved in the APeX clinical trials. Once patients decide to switch to Orlydeo, our EMPOWUR patient services team works with them to get started on product right away.
So far, most are starting on our Quick Start program, while EMPOWUR helps them through the prior authorization process. Reimbursement approvals are coming mostly through medical exceptions at this stage, but our market access team is making significant progress As payers see the strong demand from patients, payers are starting to add Orlodeo to their coverage policies and we expect this process to accelerate over the next quarter. We knew that COVID would require some adjustments and we prepared to launch in this environment. Face to face meetings with customers have been limited in many areas of the country, but physicians have been receptive to Zoom calls because they want to learn about Rolodexo. Our team has been very efficient with these interactions by transferring calls directly to colleagues when market access or medical questions come up.
Live meetings and congresses are not quite the same in a virtual format, but we've seen a lot of interest in our virtual education events for healthcare providers and patients. For example, over 200 patients attended 2 virtual events earlier this month. We also see that physicians and their patients are communicating via telemedicine when in person visits are not possible. And many Physicians have been comfortable prescribing Oralideo remotely because starting an oral medicine does not require training. Our U.
S. Launch is off to a strong start in meeting the pent up demand from patients in HAD treaters. Looking forward to Europe, Our market research tells us there is also significant pent up demand for the 1st targeted oral treatment. The difference in Europe is that prophy use has been limited by lack of options. So we have a great opportunity to grow the prophy market with Orlydeo.
Just as we did in the U. S, we have built a team with deep rare disease experience and passion for launching innovative drugs. Germany will be our 1st commercial launch in Q2 and we look forward to reporting on multiple global launches in the coming quarters. Now I'll pass it to Megan to provide more color on how we are starting to change the HAE treatment paradigm and to describe launch preparations in Japan.
Thanks, Charlie. Medical Affairs is partnering closely with Charlie's team to support a successful launch. Our efforts are aimed at increasing physician knowledge and understanding of Orlydayo. Overall, Healthcare providers are embracing the strength of our clinical data and product profile. In particular, the comparisons of how patients do before and while on Like the mean attack reduction from a baseline of 3 per month to 1 per month sustained over time and the attack free periods many patients are experiencing in our longer term safety study.
We continue to generate additional supportive data, Including what we'll share at AAAAI, which starts tomorrow, we'll show the positive outcomes of attack reductions and less on demand use regardless of prior prophylactic experience or baseline attack frequency. This adds to the body of evidence Helping physicians and patients understand the breadth of experience and improved outcomes while on Orlydeo, including from patients who've been on other prophys before. Our medical strategy is also focused on the shift towards individualized treatment plans that best meet the needs of patients with respect to reducing both disease and treatment burden. The recent publication from Doctor. Banerjee at Mass General outlining a model for shared decision making in HAE is evidence of this movement in the field.
In addition, our burden of treatment data is resonating. Physicians acknowledge injection fatigue and needle phobia is real. Breakthrough attacks still occur while on other prophys. And patients and caregivers want a treatment that is easier to administer. Our research shows Patients want more than only attack reductions.
This is why it's so important for physicians to ask about each patient's needs even if they believe the attacks are under control. Our work is helping physicians see how ORLA DAO offers patients Both the attack control they desire and the lifestyle freedom and benefits of a convenient more discrete oral once daily pill. As Charlie mentioned, with us seeing a balance of switch patients from injectable prophy products and those previously only on acute therapy, We are making early progress in shifting the paradigm. John shared how we're supporting multiple launches globally. We were thrilled to receive NHLW approval last month, marking Orlodeo's historic milestone as the first approved prophy therapy in Japan.
We chose Tori, our commercial partner, given their performance in building the HIV market. They proved they could increase disease awareness and patient identification to grow their HIV business into a $200,000,000 franchise. As a reminder, only about 500 HAE patients are identified today with prevalent estimates upwards of 2,500. With Orlodeo, Tori has the opportunity to apply their past experience to build the prophylactic market, Driving patient identification and prophy adoption similar to what we've seen in the U. S.
Over the last decade with the introductions of new HAE therapies. With approval, Torrey's medical representatives are now able to meet with physicians. They're hearing interest and excitement from physicians Our NHI pricing discussions are in progress And we expect to complete them in early Q2. After price listing, doctors can begin prescribing and Torrey's full launch promotion and marketing We will kick off. Upon successful completion of the pricing discussion, we'd receive a $15,000,000 milestone And we share inventory success with a tiered royalty from 20% to 40% of net sales.
In addition to the commercial launches, we're equally focused on advancing our Factor D program and pipeline. I'll turn the call over to Bill for more on our clinical progress.
Thanks, Megan, and good morning, everyone. Our BCX9930 development program is making excellent progress, and we are excited to advance this novel Factor D inhibitor into advanced development trials Our overall goal in development of 9,930 is very clear to bring forward an oral monotherapy complement inhibitor treatment for both PNH And additional rare, serious and potentially life threatening diseases driven by the alternative pathway. Inhibiting Factor D in PNH is important for patients no matter their prior experience with C5 inhibitors. So our goal with the clinical program It's to support a label for monotherapy treatment in all PNH patients. This means PNH patients who are naive to C5 inhibitors, Patients who have had an inadequate response to C5 inhibitors and patients doing well medically, but who want to eliminate the burden of therapies from injections or infusions.
In 2020, we shared data from 4 C5 inhibitor naive patients treated with 9,930 monotherapy With doses escalated through 400 milligrams twice a day. This data showed that control of hemolysis was dose related and that the safety profile was excellent. We have since completed enrollment in the study with a total of 16 PNH patients, 10 were treatment naive We received 9930 as monotherapy and 6 were patients with inadequate responses to C5 inhibitors who received 99 In addition to the C5 inhibitor treatment. At our upcoming R and D day, we look forward to sharing the results The complete Phase 1 dose ranging trial in PNH. Here's what we plan to have in the data readout.
First, we will have data from all 16 PNH patients, the 10 C5 inhibitor naive and 6 C5 inhibitor inadequate responders Through at least 6 weeks of treatment at either 400 milligrams or 500 milligrams PRD and a range of both clinical outcomes and laboratory outcomes, Including, for example, hemoglobin transfusions, reticulocytes, PNH clone size and LDH and safety data from dosing for up to 48 weeks. At the R and D day, we'll also share new market research with you from PNH patients. What you'll see will feel very familiar as the insights are very similar to what we saw in HAE patients. There is a tremendous burden of treatment associated with injectables And these patients want an oral treatment. In 2020, we discussed our plan for dose selection and design considerations for future studies with both U.
S. And European regulators. First selection for BCX9930 is based on precedent For PKPD modeling of responses in PNH. With completion of this PNH study, we will have the information we need To choose the dose for accelerated advanced development programs across all indications, and we believe we will be ready to move straight from Phase 1 to pivotal trials in PNH. With the upcoming data readout, we will be ready to finalize our study plans and start pivotal trials in CNH and proof of concept trials in selected nephritis indications later this year.
We'll announce the details of those trials as we start them. Our strong balance sheet allows us to fully invest in this program. We are very excited by the progress we made in 2020 and the terrific opportunity we have in 2021 to bring an oral monotherapy closer to approval for seriously ill patients who complement MEDIAD's diseases. I'll now hand the call over to Anthony.
Thanks, Bill. What a difference a year makes. We ended 2019 with $138,000,000 of cash We ended 2020 with $303,000,000 access to another $75,000,000 and upcoming Orla Deo revenues from the U. S, Japan and Europe. The strengthening of our balance sheet, which takes us into 2023, allows us to focus on creating value for the company and shareholders by investing in areas that will provide maximum efficiency and return.
The main areas that we are investing in continue to be supporting the launch of Orla Deo globally And investing in the development of BCX9930 across multiple indications, while of course making sure that we have the infrastructure in place As the CFO, it's also nice to have significant financial flexibilities and levers to pull as we move forward. As the launch for Lydale continues to progress, we can make strategic and financial adjustments that correlate with the pace of the revenues that are being generated. Our investment in Factor D also continues to evolve and our continuing desire is to move quickly and broadly with the investment in this program's development. As I noted, we will also have the option if we need it to draw down the additional $75,000,000 from our existing credit facility with Ethereum. And as we showed with the financings that we announced in December, we have future opportunities to access capital with our growing portfolio of assets.
Because of these many variables, we are not providing specific revenue or operating expense guidance in the launch period for Orla Deo. Based on our expectations for revenue, operating expenses and our option to access the additional 75,000,000 We believe our current cash runway takes us into 2023. This position of financial strength allows us to focus on execution, To focus on value creation and not on near term cash needs, that's a new and exciting spot for BioCryst. BioCryst is transforming and so too is our value proposition. We are a commercial stage rare disease company and Orlodeo will generate meaningful revenue With BCX9930, the development team is working on a drug that has huge potential across multiple indications.
The team in Birmingham continues to discover our next generation of medicines for rare diseases and we are now in a strong financial
Please standby while we compile the Q and A roster. Your first question comes from the line of Jessica Fye with JPMorgan.
Hey, guys. Good morning. Hope all is well. I had a few financial questions. First, on Bloomberg's oral data consensus This year is around $35,000,000 Are you comfortable with that number?
2nd, how should we think about gross to nets in the early part of the launch And could that evolve as you get coverage ramped up? And 3rd, where does formulary coverage stand now? What's your goal for coverage and when do you expect to achieve it?
All
right. Thanks, Jess. I'll take the first one And Charlie, you can take the next 2. So the consensus, as we said, we're not going to give guidance. Our goal is to meet or beat the expectations of Wall Street, and we're excited to approach the first quarter, I'll give you a 1st full quarter in the next earnings call.
So that answer. And you want to take the gross to net?
Yes, absolutely. Hi, Jeff. So as far as gross to net goes, first of all, just a reminder for everyone that oral LDAO is the lowest WACC price in the market. And we kind of we expect gross to net to change over time. As I said in my remarks, early on, we're using the Quick Start program and We're getting patients on therapy via medical exception primarily.
And so we expect this to the gross to net to evolve in the year as we get more policies So we're being conservative in how we look at gross to net for year 1 and we encourage other people to be conservative in your estimates for year 1. As far as coverage, as I mentioned, we're starting to have some early successes with plans putting ORILIDEO onto policy We're getting very good feedback from payers in terms of the value proposition of Orla Deo and understanding The patient demand for Orodeo, so we're really expecting coverage to accelerate this quarter. It's going to be a year long process for some payers. So it will continue to evolve, but we expect to make a lot of progress in the next quarter.
And Charlie, the other thing you might want to just mention is, In the interim, while we're working through negotiating for policy, what are we able to do to get paid?
Yes. So absolutely. So the first The thing we're trying to do is make sure that patients get right on therapy right away. And then we're working through medical exception processes with payers, And we've had some early success with that. It's a more labor intensive process, but it's one that we're working closely with physicians and patients on and so that's working many patients.
And we get more leverage, Jess, the more we fill the funnel with new starts. So that's a primary focus of Charlie's team.
Great. Thank you.
You're welcome.
Your next question comes from the line of Ryan Chiang with Bank of America.
Hi, team. Thanks for taking my questions this morning. My first question is on Oladeo. Can you give me an update on the rate of conversion from your EAP and When do you expect the conversion to fully complete based on what you're Seeing so far. And I have one follow-up.
Sure, Brian. This is Charlie. I'll take that question. So the conversion is Just about complete at this point. We set out to make that conversion this quarter and we're really wrapping that up at this point.
And as I mentioned in my remarks, we're seeing Great majority of patients who are on the 2 clinical trials plus our EAP deciding to continue on ORILDEA In the commercial world.
And Charlie, there's 2 steps in that process, right? There's converting them to commercial drug and then there's They have to go through the same prior authorization and the insurance.
That's right. That's right.
So what
we worked with the clinical sites is getting The start forms for patients and then they go through the prior authorization. Some of those patients just like the brand new ones will go on QuickStart. And then as I just mentioned, we're working through medical exceptions and ultimately policies for those patients. But we're really encouraged with the progress on the
Okay, great. So maybe just one more on 9,930. So we'll be getting data with Patients getting the high dose at 40500 for at least 6 weeks next month. Can you remind us that the trial allows The inadequate responders to wean off C5 since you're using the 9,930 as an add on. Is there potential for us to see the effect of
Bill, do you want to take that one?
Sure. Good morning. Thanks for the question. Yes, the protocol does allow the patients who are inadequate responders to have the C5 inhibitor withdrawn. So we'd like to see everything be stable.
It can take quite a while for the hemoglobin to plateau out, for example, and it takes a long time for the bone marrow to Get to a new steady state. So in each individual, there'll be that opportunity. It's too soon in the study To see that data yet and it's possible we might have that data later this year.
And It's a great question, Brian, because again, the goal is monotherapy, as Bill said in his prepared remarks.
Great. Yes, I agree. Thank you so much for the answers. Looking forward to the data readout.
Great.
Your next question comes from the line of Gena Wang with Barclays.
Hi. This is David for Gena. So I have a couple of questions. The first one is on the PNH 9,930 asset. So it seems to me that all of 16 patients being treated.
Is there any new cases of rash
that's being observed? And can you just give us some additional thoughts around the mechanisms of the downside rash?
Bill, you want to take that?
Sure. So as we noted last year, we've had some cases of Inconsequential rash and these events disappear as BCX-nine thousand nine hundred and thirty treatment continues in So we'll update that at the R and D day call With the new data cut that's coming up, it hasn't been an issue. And with regard to mechanism Action. If you look in the literature and we've done extensive consulting, actually, this started way back in the development program and we saw a few similar cases. It's seldom that you actually work these things out for these benign Crashes, exactly what the making of that is.
So we don't expect that we'll have Laboratory investigations that work out the mechanism exactly that almost never happens.
But the main point is it's benign, it goes away and you can keep dosing up. So in our view, It's really non consequential.
Yes, that's really helpful. So another question is around your registrational trial for 9,000,000 30. I understand that you're probably going to share some additional color On the R and D Day, I'm just wondering if you can share some initial thoughts around the registration trial. Would it likely be a single arm trial or Do you have an arm with C5 inhibitor to show some superiority or superiority?
Bill, you might want to just focus on what's the goal of the label that we're shooting for with the drug and then that can help Give them a sense of what we need to study.
Sure. So just to clarify one thing. At the R and D Day, I won't be going into designs Future studies. When we start studies, we'll talk about that later this year. At the R and D day, we'll go over the data from the ongoing Study which we're very excited about to share with you.
And the goal for treatment here is To make our oral drug available for every patient with PMH as a monotherapy. So that means that Probably have to do more than one study because there are people who are not currently on C5 inhibitors for various reasons and there are people who are currently on C5 inhibitors. Some of them are not doing so well and having inadequate responses and some of them are doing okay. But oral drug has Powerful attraction. So we'd like to be able to cover all the bases.
You can have a look at other sponsors' Studies that are published and there's a history of controlled clinical trials in the field. I think that would give you some guidance as to where the standards are.
I think the most exciting part is we're going from a Phase 1 study into Pivotal's and Bill and his team have done a fantastic job of being creative And getting us to accelerate. That's going fast.
Great. Thank you for the color.
You're welcome.
Your next question comes from the line of Brian Abrahams with RBC Capital Markets.
Great. Thanks for taking my questions. This is Steve on for Brian. Those early days in the rollout, can you share whether ORILDEA uptake is even across severity With mild and severe patients equally represented there and any breakdown on whether new patients are coming from general practitioners or specialists? Thanks.
Sure. Hey, Steve, it's Charlie. As I said in my prepared remarks, we're really pleased with the breakdown of patients thus We're getting an equal split with people coming from switching from injectable prophys and those who are treated with acute only and then Coming over to prophy for the first time now that Orlandeo is available. As far as the prophy switches, we can't Comment specifically on the severity of those. They were on prophy already, so they're pretty severe.
But what our clinical data shows is that regardless of background therapy, Regardless of treatment rate, patients across the board do well on Orlandaio.
And then his second question was the Doc prescribing is a GV specialty? Yes.
I mean at this point, this is predominantly a market that's treated by allergists to immunologists. And we know where those doctors are and we're really excited because we're moving well beyond the group that did our clinical trials And we're seeing real uptake in a broadening base of those specialists. Eventually, we'll get some GPs and others too, but right now we're focusing on the big top treaters.
Your question is a good one. And one of the benefits of COVID is the fact that you're not behind the steering wheel driving to the next clinic or you're not in an airplane. And so diving deeper into the list, I mean, as Charlie said, the initial part of the launch is focused on the high prescribers, but we can work our way through the list Over time and doing it remotely or virtually is a real plus.
And your next question comes from the line of Maury Raycroft with Jefferies.
Hi, good morning, everyone. Congrats on the progress and thanks for taking my questions. My first question was on 9,930 data at your R and D day. I guess how should we think about hemoglobin variability And the bar for success on hemoglobin measures for the naive and experienced patient populations.
Bill, you want to take that?
Sure. Hi, Murray. Thanks. It's an interesting question. The leading physician to treat PNH patients We've started to think about what are the goals of treatment in the era of introduction of proximal complement inhibitors into clinical research.
And there's a nice publication on that that talks about grades of benefits. So controlling the transfusions and having people not be dependent on transfusions. It's a big goal. And to do that, you need to stabilize the hemoglobin. And it's clearly better for people If their anemia is relieved and their fatigue improves.
So I think that controlling transfusions and Having the hemoglobin go up, in that publication, early publication as a broad start up, There were various metrics included for hemoglobin, including 8 grams, 10 grams and 12 grams per deciliter. So I don't think there is a single magic number is the answer. The goals here are to control the transfusions and improve the anemia and improve the symptoms of the disease.
Got it. Okay. That's helpful. And then on clinicaltrials dot gov, the estimated enrollment for PNH was relatively high. Just wondering if you can provide any insight into the enrollment rate for this study and remind on rationale for why you didn't add more sites for this study?
For our Phase 1.
So
this was an innovative design that included PNH patients in a Phase 1 first in human study, we started off with healthy subjects, single ascending dose, healthy subjects, multiple ascending dose. Part 3, the study, we designed in an incredibly flexible way because when we started, we didn't know how many subjects we would need to complete first ranging. So what we did there was have potential for multiple cohorts starting at different doses that we worked out along the way. And we wanted also to study a number of patients with C5 inhibitor inadequate response history And a number with no history of ever having a C2C5 inhibitor. So that flexibility was basically there wasn't a particular Number that we had in mind.
We had enough in the trial design that we had a good envelope and we needed no more than 16 to hit our objectives.
Yes. That piece is really important. We always put numbers so we don't have to add amendments to increase the study size. 16 was plenty to figure out the dose. The other thing is it's a rare disease.
So you don't you can't use these patients in the next study. So if you over enroll in early studies, you have a more challenge in Recruiting for the later studies.
Got it. That makes sense. And maybe last quick question. So You've talked about providing clarity on additional indications to pursue with 9,930 that you could move directly into Phase 2 with. And it sounds like we can learn more about this at your R and D Day.
I guess just clarifying if that's the case, if we should expect an update on that? And then can you say if you've already reached some alignment with regulators on moving directly into Phase 2s?
Bill, you want to take that?
Sure. On the first question with regard to the nephritis indications and other indications, at the R and D Day, we will go over the field And how exciting it is and what the opportunities might be. We won't be specifying exactly what we're including in our Nephritis studies until we stop them because we've seen no it's very competitive field and don't advertise Exactly what we're doing before, if that's what's necessary. With regard to the second question on interactions with regulators, we had very good interactions last year. And the 2 key topics were how do we pick a dose for pivotal trials, and that's based on PKPD modeling, and we've got alignment on that.
And the second was just general design considerations around pivotal studies and moving directly from the Phase I dose range So here's some of the alignment around those general considerations. So we need to finalize our designs, wrap that up and And whether this year we'll be in a position to start.
This is another efficiency, Maury, in terms of being able to do a Dose ranging study in PNH patients in Phase 1 and then have the dose to be able to go into other indications. That really accelerates the program.
Yes. Let's talk about a key point, right? So Factor D is not the targeted mutation in any of these diseases. There's a whole range of different things can happen that disturb the complement system and activate the alternative pathway all the way from PIGA mutations in PNH in bone marrow stem cells to germline factor H mutations and so on. So none of those are mutations in Factor D.
So Factor D just happens to be the enzyme that starts the alternative pathway and The dose that treats is adequate to inhibit Factor D in PNH is the dose that's adequate to inhibit Factor D and everything else.
At this time, there are no further questions. And I will now turn the call over to Mr. Stonehouse for concluding remarks.
So first off, let me again thank you for joining us. This is a really exciting time at BioCryst. So we look forward, 1st off, to be sharing the 9,930 Phase 1 dose ranging data with you at our R and D Day on March 22. And we also look forward to sharing the 1st full quarter of Orlandeo sales at our next earnings call. So as I said before, The transformation in this company is happening now and we hope that we've gotten your interest and if you like to reach out to us, we're happy to connect with you in the meantime.
So thanks again and have a great day.