Q4 2019 Earnings Call
Ladies and gentlemen, thank you for standing by and walk into the Alexia Pharmaceuticals fourth quarter and full year 2019 results conference call.
This time, all participant lines are in listen only mode.
After the speakers presentation that'd be a question answer session. Please.
Please be advised to today's conference maybe recorded.
I'd like to hand, the conference over to Morgan Sanford Director Investor Relations. Please go ahead ma'am.
Thank you operator good morning, Thank you for joining us on today's call to discuss Alexey ons performance for the fourth quarter and full year 2019.
Today's call will be led by Ludvik Hanson, our CEO , but it will be joined by already broadness or in our Chief Financial Officer, John or lost our global head of R&D, and Brian Golf, our chief commercial and global operations Officer.
You can access the webcast slides that will be presented on this call by going to be events section of our Investor Relations page on our website.
Before we begin I would like to point out that we'll be making forward looking statements and these statements involve certain risks and uncertainties that could cause our actual results to differ materially.
Please take a look at the risk factors discussed in our FCC filings for additional detail.
These forward looking statements apply only as of today and we undertake no duty to update any of the statements after the call except as required by law.
I'd also like to remind you that we would be using non-GAAP financial measures, which we believe provides useful information for the understanding of our ongoing business performance.
Reconciliations of our financial results and financial guidance are included in our press release.
These non-GAAP financial measure should be considered in addition to but not as a substitute for our GAAP results. Thank you bye-bye.
Thank you Morgan and good morning, everyone.
Before we review our fourth quarter and 2019 full year performance I.
I would like to take a brief moment to announce that we have successfully closed on <unk> acquisition of the Kilian pharmaceuticals, which represents an important step in diversifying our business.
True. This acquisition, we had two clinical stage assets to our portfolio with Daniel pen and five two to eight.
I'm thrilled to welcome are acutely on colleagues to election and excited about the opportunity to collaborate on the development of disaffected D assets for a broad range of rare diseases.
Turning now to our 2019 performance, we delivered on all of our key objectives and in many cases have surpassed all goals.
Well to marry with its not a market leader in P. any age you know three larger markets, the U.S., Germany and Japan.
Well to make it was H.U.S. conversion is progressing well in U.S. and we anticipate launching indeed, you and Japan this year.
We are also very pleased with the uptick although neurology franchise with continued growth of Soleris in G.M. Gi and the launch in an invoice D.
And just over two years no all the GE has become our largest franchise in U.S. like patient volumes.
Well ambition is to quadruple the number off Mg and I'm always de patients treated by Soliris and eventually build to mayors and U.S. by 2025.
Well metabolic portfolio continues to deliver strong growth as we work to expand access for H.P.P.L.D. patients.
Importantly, we.
We have made great progress on all pipeline and have an ambition for 10 launches from now until the end of 2023.
The combination of new assets, new Fulminations and new indications.
And once again have delivered on all financials were 21% revenue growth and 33% non-GAAP earnings growth in 2019.
Turning to slide six.
We have a clear strategy for long term value creation.
First we will move past Solaris and establish ultimately assess markedly in p. and each in each U.S. INO three key geographies.
Secondly, we will expand on seed pod franchise beyond the end each in each U.S. into larger rare diseases.
We have altimeters programs plant in six new indications, including four neurology and two nephrology indications in parallel we will continue to innovate for patients with new formulations and sub acute treatment options.
Finally.
We will diversified portfolio beyond see thought.
Kelly on is the most recent example of this effort, which affected d., we have the opportunity to pursue development in a broad range of indications.
Outside of this transaction, we have built a robust rare disease pipeline over the past few years and have clear line of sight to multiple potential blockbuster launches, including treatments for Wilson's disease and email amyloidosis.
We have significant financial capacity to continue to diversify our pipeline in the future.
In addition to bringing in external assets to diversify our business. We are evolving our leadership in complement to expand our addressable patient population.
On slide seven you can see a business this rapidly moving beyond Solaris.
Well to mirror is approved for two indication.
Ladies and gentlemen, please standby.
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You may resume.
Yes, I just this leads accounts and again, we had a technical issue.
I hope that you guys can hear us okay. So what I will do is instead of restarting we're gonna start on slide six.
And then we will take it from there.
So turning to slide six.
We have a clear strategy for long term value creation.
First we will move past Solaris and establish old to mayors as market leader in P. and each in each of us in our three key geographies.
Secondly.
We will expand or C. Five franchise be on ph in each of us into larger rare diseases.
We have ultramist programs planned and six new indications, including four neurology and two nephrology indications in parallel we will continue to innovate for patients with new formulations and subcu treatment options.
Finally, we will diversify your portfolio beyond C. Five Killian is the most recent example of this effort, which affected d., we have the opportunity to pursue development in a broad range of indications.
Outside of this transaction, we have built a robust rare disease pipeline over the past few years and have clear line of sight to multiple potential blockbuster launches, including treatments for Wilson's disease and al amyloidosis.
We have significant financial capacity to continue to diversify our pipeline in the future.
In addition to bringing an external assets to diversify our business. We are evolving our leadership in complements to expands our addressable patient population.
On slide seven you can see our business is rapidly moving beyond Solaris.
Bill commitments is approved for two indications and in development for six additional indications across neurology and nephrology.
This year, we will transition to a high concentration formulation, which will shorten infusions to only 45 minutes.
Next year, we plan to launch all once weekly on body Subcu ultimately as formulation.
Offering patients are home base self administration option.
Our next generation Subcu assets.
Tim 10, and 17 20 offer improved patient dosing regiments.
We have significant optionality for indication selection with each of these assets.
From there, we will expand with AQX Helios factor the platform.
We see immense opportunity for oral proximal complement treatments to transform standard of care in many complement mediated diseases.
On slide eight.
You see that once again, we have delivered strong top and bottom line growth for the fourth quarter and the full year.
Which provides a solid foundation to continued to deliver on our value creation strategy.
Again, I'm very pleased with our strong execution against our 2019 priorities and excited for 2020 as we built on our successes.
With that I will now turn the call over to around that.
Thank you Ludwig starting with Slide 10, we reported fourth quarter total revenues of approximately 1.4 billion, an increase of 23% year over here.
This was driven by strength in our neurology franchise continued growth in the core businesses and ultra Maris launch.
Our non-GAAP operating margin was 51%.
A reduction of 155 basis points versus prior year, driven by increased R&D spend as we advanced and further build our development portfolio.
non-GAAP EPS was $2.71, representing 27% growth year over year, driven primarily by strong topline growth and lower effective tax rate.
Moving to slide 11.
Fourth quarter total net product sales were primarily driven by patient volume growth in our key markets.
Turning to slide 12.
Solaris revenues in the fourth quarter were approximately 1 billion with each year over year growth.
4%.
Solaris revenue growth was driven primarily by GMT revenues, partially offset by Ulta Myrisk conversion dynamics.
Aftermarket revenues in the fourth quarter were 170 million, which now includes contributions from atypical H. you asked in the United States.
Metabolic revenues in the fourth quarter were 201 million, representing 32% year over year growth.
Turning to the BNL on slide 13.
During the quarter non-GAAP R&D expense was 227 million or 16% of revenues.
non-GAAP EPS DNA expense was 340 million or 25% of revenues.
non-GAAP effective tax rate in the quarter was approximately 12% and continued to benefit from certain onetime events, including the release of state income tax reserves related to the conclusion of an audit.
We reported fourth quarter, non-GAAP EPS of $2.71 growing 27% year over year.
GAAP earnings per share were $4.
We ended the fourth quarter with approximately $2.7 billion in cash and marketable securities.
This is not adjusted for the Kelly on transaction.
I'll now turn to slide 14 for our 2020 financial guidance.
We are guiding to total revenues between 5.5 billion and 5.56 billion.
This represents 11% growth year over year at the midpoint of the range.
For Solaris, an ultra Maris, our revenue guidance is 4.755 billion 4.800 billion.
This assumes continued momentum for Solaris MGMT, our ongoing launch of Solaris and animal study and the launches of Alta Maris for P. NH, an atypical HLS.
Turning to metabolic our revenue guidance is 745 million to 760 million for both Strensiq and Kanuma.
This includes the impact of the strategic pricing decision priest transact in the U.S. disappear sustainability and access given weight based dosing.
In 2020 and beyond it is important to consider the dynamics associated with conversion from Solaris to Ulta Maris as it relates the annual cost per patient.
There's a revenue benefit when each patient starts ulta myrisk BNS treatment due to the increased number of vials consume during the loading dose.
We benefited from this loading dose dynamic having converted 60 plus percent of patients.
In P. NH to Ulta Maris over the course of 29 team.
We now expect to be impacted by lower animal treatment cost per patient as the majority of patients move to maintenance dosing.
In atypical H.U.S. and other indications and development, we will see lower animal cost per patient compare to Solaris for both loading dose and maintenance building.
It is also important to consider quarter over quarter variability due to every eight week dosing for Ulta Maris.
However, this quarterly fluctuation will even out on an annual basis.
We have included a slide in the appendix of this presentation to provide a summary of this dynamic and to serve as a reference going forward.
non-GAAP operating margin is expected to be between 53.5% and 54.5% of revenues.
non-GAAP R&D expense is expected to be between 17.5% and 18.5% of revenues and represents a step up of approximately 270 million versus prior year consistent with our intention to further build out and progress the pipeline.
Clinical program spend particularly for late stage development is planned to increase in 2020 .
R&D expense also includes program costs and potential milestones for previously announced BD transactions and collaboration.
non-GAAP EPS DNA span is expected to be between 19.5% and 20.5% of revenues for the full year 2020 and reflect increased leverage from top line growth.
We expect the non-GAAP effective tax rate to be between 16 and 17%.
In 2019, the non-GAAP effective tax rate benefited from certain onetime item.
Absent. These onetime benefits are 2019, non-GAAP tax rate would have been approximately 15%.
We expect our non-GAAP effective tax rate to increase in the future as a result of das regulation changes outside the U.S.
GAAP EPS is expected to be between $7.91 an $8.71.
non-GAAP EPS is expected to be between $10.65 and $10 an 85 cents.
The midpoint of the non-GAAP EPS is approximately 2% growth year over year as a result of increased R&D spend and an increase tax rate compared to prior year.
This guidance reflect the financial impact of our recently closed a Kelly on acquisition, but does not reflect any future M&A that we may pursue.
As you can see on slide 15, we've established a track record strong financial execution.
Since 2017, we have delivered double digit total revenue and non-GAAP EPS growth, while maintaining a competitive non-GAAP operating margin.
We continue to invest in our R&D programs and have increased our non-GAAP R&D spend as a percentage of revenues to within 16% to 19% in line with our biotech peers.
With the current momentum of the business, we're well positioned to deliver on our 2020 financial goals.
Ill now turn the call over to John to provide an update on the R&D.
Thank you arena on Slide 17, you can see our current development portfolio. We now have 19 planned clinical stage development programs for 2020.
In the coming weeks and months, we expect to report interim data from our phase three once weekly on body subcutaneous auto mirrors program in update on our anti Fcrn studies in interim data from the phase two study organic copan and see Threeg.
We're excited about the acquisition of a killing on and look forward to providing additional detail in the coming months as we embark on the integration.
Just a few weeks ago, we reiterated our ambition to execute 10 launches by 2023 from our current portfolio.
On Slide 18, you can see our R&D highlights, which summarize these programs, including stage in clinical development and the estimated addressable population.
We are expanding our C presence well beyond the Pan Asian, atypical hqs business in our advancing Ulta myris into five additional indications across neurology nephrology.
Together, the ultra mirrors programs present, an opportunity to expand our treated patient population by tens of thousands of patients.
We believe in the compelling value proposition of ultra mirrors, which has been received well by patients physicians and other key stakeholders and are continuing to innovate with a high those concentration reducing infusion time to 45 minutes in a once weekly on body Altamira subcutaneous formulation.
In addition to ultra mirrors indication expansion programs, we see opportunity to diversify our business beyond C. Five with four additional late stage novel assets.
Our phase three superiority trial for Alex on 18 40 in Wilson's disease remains ongoing 18, 40 is an oral once daily therapy with 10000 fold higher affinity for copper than current standard of care key leaders, which have core compliance rates due to burdensome dosing regimens.
We're on the verge of completing enrollment and expect to topline read out in the first half of next year.
We plan to initiate a phase two three program for CA 101, inhale amyloidosis in the coming months, we see potential for this late stage asset to transform the treatment of al amyloidosis, a disease characterized by Misfolded cap on Lambda light change, resulting an abnormal deposits of amyloid, which can lead to organ failure.
Patients are currently treated with Chemotherapeutics agents not approved for amyloidosis and median survival rates are only 18 months post diagnosis.
Clinical data supporting our rationale for the collaboration showed a 63% overall organ response rate in addition to efficacy on cardiac and renal endpoints.
Our phase two three program, we'll look at an overall survival primary endpoint with patient function quality of life in cardiac imaging, serving a secondary endpoints.
Last year, we announced a license agreement with iOS to develop income or commercialize AG 10 for 80 TTR cardiomyopathy in Japan.
Agee 10, as a small molecule designed to address these stabilized and misfolded transpired in protein, which is the root cause at 80 TR.
We believe Agee 10 has potential to stabilize TTR in heart disease progression.
Pending regulatory discussions we plan to extend the Agee 10 development program into Japan later this year.
Finally, we're excited about our acquisition of a killing on Ns factor de platform.
Killing on reported positive phase two data Fergana, copan MPN, aged patients with extra Vasco homologous at a medical conference last year, we see opportunity Fergana copan in the small subset of pianist CNH patients with extra vascular mosses.
We see additional opportunity Fergana co Canyon C Gi and expect interim phase two data in the coming weeks and we see great potential for AC age five to two way as twice daily best in class factor de oral treatment MPN age in a broad range of rare diseases.
We are excited about the opportunity for these 10 potential launches to significantly exam expand the number of treated patients.
And look forward to providing you with updates as we progress through the year.
Moving to slide 19, we have plans to further expand and diversify our C leadership with our next generation assets.
Starting on the left our weekly subcutaneous formulation of ultra mirrors for use in Pn age in a typical hqs isn't an ongoing phase three PK based trial.
Leveraging the west Jan on body device. We believe this will provide patients with the flexibility to choose how they wish to manage their D disease within their lifestyle lifestyle.
We are expecting interim PK data in the second quarter this year with the potential launch in 2021.
Next we have the opportunity to evolve our terminal complement subcutaneous treatment options with Alex and 17 20 in 18 10.
17, 20 years, our internally designed by specific Cfive inhibitor.
At only 25 killed owns 17 20 is a unique mini body tailor made for convenience subcutaneous administration.
We see opportunity for this asset in a number of larger rare disease indications and we look to initiate a proof of concept study in the first half of next year.
Finally, 18 tenders are co formulation of all to mirrors and Halozymes ph 20, ironic days, which allows for bi weekly subcutaneous dosing.
We recently disclosed our plans to start a phase two renal basket trial with 18, 10 and look forward to providing additional updates as this program progresses.
Together these three assets represent an opportunity for election to expand our offerings for patients living with complement mediated rare disease.
Our development portfolio has grown significantly in the last two and a half years and I'm incredibly proud of all the hard work undertaken by the entire R&D organization.
With that I'll turn the call over to Brian to provide commercial highlights for the quarter Brian .
Thank you John turning first to slide 22.
We've seen unprecedented progress excuse me in establishing Ulta mirrors has the market leader in Pn age.
This is due in large part to the compelling value proposition, which includes strong data from the largest and most inclusive pn each clinical program ever conducted.
The brought inclusion criteria in the two phase three trials insured or study patient population would be representative of the real world Pn age population.
Specifically, we enrolled transfusion independent in transfusion dependent patients with no baseline hemoglobin or absolute ridiculous site count requirements. We also included patients with prior history of bone marrow failure, which is critical because roughly 40% to 50% of ph patients have a history of bone marrow.
So failure or a plastic anemia.
As of Monday of this week, we've converted 60% of ph patients to ultimately this in the US 62% in Germany, and 53% in Japan, making Ulta mirrors, the P. NH market leader in our three largest volume countries.
Our latest launch of all to Myris in a typical each us of the US is also off to a strong start.
While it's still early days conversion is tracking in line with the P. NH conversion curve at the same time point since launch.
Or neurology business is now our largest franchise by patient volume in this was achieved in just two years since launch.
On Slide 23, you can see we exited the fourth quarter with 1885 patients on treatment with Soliris for Gmg in animal Westy in the U.S.
We've made significant progress advancing our presence in gmg and with our animal Westy launch.
Gmg patients continue to have broad access to Solaris.
Our strong and Immodesty launch is underpinned by a remarkable phase three data showing 98% of patients relapse free at 48 weeks with sustained efficacy out to three years.
We're making progress educating payers on the severity of animalistic attacks the objective of preventing all relapses and the difference between animal as CMS.
As a result of these efforts payer adoption of coverage policies for intermodal SD has been rapid and we're seeing strong adherence to soliris therapy in both GM Gi and ammo as Steve.
Looking ahead, we're well positioned to deliver on our ambition of quadrupling or us gmg and immodesty treated patient population within the next five years with potential for also mirrors to launch in late 2022 or early 2023 as in every eight week infusion.
Or once weekly on body subcutaneous formulation planned to launch simultaneously with the IB formulation will provide another important treatment option for patients who prefer self or home based administration.
Our target Gmg population represents more severe uncontrolled patients and we believe this is a unique space, where Solaris and then also myris can serve as a highly effective treatment option.
In emo SD our target patient population mirrors inclusion criteria.
In our phase three cilliers prevent trial.
With our dedicated neurology team, we believe our commercial organization is well positioned to deliver on our 2025 ambitions.
I'd like to take a brief moment to thank both our global commercial and global operations organizations for their hard work and dedication, which has enabled us to excel with multiple launches and continue to bring hope to the rare disease patients we serve.
Ill now turn the call back to Ludwig for closing comments literally. Thank you Brian once again I'm very proud of what the team delivered 2019, we're well positioned to further build on our momentum in 2020.
And there's much to look forward to this year.
We have laid out a clear strategy to deliver long term shareholder value by establishing ultimately this as market leader in P. NH in each of us expanding our presence and C, including plan programs in the analogy and nephrology and continue to look for opportunities to diverse.
Supply of business beyond C.
Importantly, we maintain our unwavering focus on patients and our commitment to advance our mission to deliver life changing therapies to people living with rare diseases.
With that we will now open the call two questions operator.
Ladies and gentlemen ask a question do we need to press star 100 telephone.
So as draw your question press the pound key we ask that you limit yourself to one question. Please standby we've compiled acumen a roster.
Our first question comes from Cory Kasimov of JP Morgan Your line is open.
Great. Good morning, guys. Thank you for taking the question.
Yes, I just want to get a better sense of the drivers behind your guidance for 2020, particularly on the top line on the surface. It looks pretty conservative business, primarily just a function of the pricing dynamic of assuming moral tumors patients on maintenance dosing. This year or are there. Other factors that are also important behind the scenes that I'm missing.
The runner to answer is yes, you're right, but go ahead. So first of all we add an amazing year end 2019, 21% topline growth, 33% EPS growth.
Exceeded all our conversion.
Star gets six BD deals at 2019 was an amazing year.
On 2020 , we've guided to 11% topline growth. So there are few dynamics that are going on here first of all we had because we had great conversion from Solaris to him Ulta Medicine 2019, as we go into 2020 there'll be an impact to revenues due to the lower animal cost of pre.
Men per patient as majority of patients have now already converted and we'll now go into maintenance dosing that's on the Pmeight side.
On the atypical Hqs side, we're just starting to launch Ulta Maris there, we do not have the loading dose benefit there in fact on the first year, there's a 22% lower price per patient annual treatment cost and an ear to there's a 33% lower threed.
And cost annually for the patient.
As a result that dynamic also is sort of a headwind for from a revenue standpoint. This is to some extent mitigated by our urology growth as you know we put out an ambition for neurology, having four X. The number of patients by 2025, So we're still seeing strong years.
Allergy growth.
On the patient volume side. In addition were also seeing.
High single digit growth for IP, NH, and atypical aid us patients and our metabolic business continues to grow as well. So it's a mix of all these different factors that impact the topline.
On the bottom line there are several other factors that impact the EPS guidance.
As you can see our R&D spend has going up substantially it's about a 270 million dollar increase on a dollar basis.
And it's 19 clinical programs that you have heard about many of which we did not have in 2018 or 2019.
In addition, the R&D spend also includes the spend that we will have as a result of the close of the a Kelly on transaction. In addition, the R&D spend includes the BD transactions that we've already announced and the milestone that we expect to pay for those transactions as those programs move forward.
In addition, you see that the tax rate, which was on a non-GAAP basis, 13% in 2019 is on the midpoint expected to be between or six between 16, and 17 or 16 and half percent. So that's about 350 basis points change from 2019. So those are some of the factors that impact.
Act the Bottomline.
Or does that answer your question.
Yes. It does its for the call is very helpful. Thank you very much okay. We'll take the next question operator.
Our next question comes from Geoff Meacham of Bank of America. Your line is open.
Morning, guys. Thanks for the question just have a couple of quick ones for for Brian , Jeff deadlines picking up a little bit very difficult to here.
As a better.
Okay, let's try okay. So for Brian on on North America conversion are there are differences between DNA Chen Hqs.
And down the road anemone Mg with respect to conversion from sellers I wasn't sure third nuances.
When the indications are of the 70% target was broadly applicable and then.
Literally just curious if there had been further dialogue with between you and Elliot since the announcement and maybe just highlight where you see the biggest differences between.
And opinion between the strategies going forward. Thank you.
Hey, Jeff Brian I'll start on the.
On the conversion first of all your comment on is the 70% broadly applicable to our.
Base business appealed HD typically choose the answer is yes.
We have the same ambition of course, we have made excellent progress on pn, each and as we reported now under three largest markets with PNC, which were over the 50% Mark So ulta mirrors definitively the market leader a typically choose is a different dynamic in terms of conversion because it's a more acute condition.
So you have many of the patients will start in the inpatient setting and they may actually start on Soleris, but then as soon as they are discharge theres an opportunity for facilitated patient conversion to Ulta mirrors and part of that is hospital formulary dynamics in part is just awareness of ultra mirrors availability, but.
Again same ambition and the other half of your question was around neurology and I guess, you're you're asking about with Soleris, because it's too premature to talk about ulta mirrors in neurology and there are very different dynamics between GM GE and emo as C.
So we're really pleased with the progress we're making with both launches gmg as you know is two years and counting in in the US we continue to to continue to make progress in both breadth of prescribing as well as depth or prescribing.
In in Emo SD, we began that journey in the middle part of last year. The launch is a very much on track and we gave the combined numbers of fee as of the end of last year 1800, 85 patients. So that that starting point of two years with gmg in six months plus within a moas Steve.
And the progress we've made has really set our ambition to be at Fourx.
Within five years from now.
And with respect to your second question Jeff.
So we continue to have a constructive dialogue with elliot's as we have with all of our shareholders. As you know our dialogue with L. you started in 2017, and we listen very carefully to to all of you.
We also believe that we have a a stock that is undervalued, especially giving our strong execution.
In.
We'd so the management team, including the board's.
Believes that we have a strong strategy in that we need to continue to focus on executing that strategy and there will create long term shareholder value as not much more that can that too to that.
Operator question Wes.
Our next question comes from Geoffrey Porges SVP Leerink. Your line is open.
Okay. Thanks couple of questions first the roadmap.
On the guidance.
So it sounds to me as though you're saying that ultimately this is guided to be sort of flattish to down because there is obviously a strong underlying trend in solaris so.
If I just take me Q4 revenue run rate and carry that forward then I get to to your guidance for 2020, so it sounds as though you're telling us that ultra mirrors.
He is actually going to go down compared to the Q4 run rate because of the dose shift and I just want to make sure about flair and then another communication clarification question.
Your 10 launches by 2023.
Is that what you see being possible or is that your strategic commitment, meaning if some of those which are currently high risk such as iOS or even the carry on program.
If the if they fall by the way side and the trials on successful will you out other programs to ensure that you deliver turn by 2023 I just want to understand how to think about that thanks.
Sure.
So I'll address the first question and then John can address the second question.
So I don't think it's accurate to assume that Alta myrisk revenues are actually going down we expect Ulta Maris revenues do still go up for a number of reasons first of all we've only converted say around 60% of the market in our three major geographies and there is.
Well, you know long way to go.
On the PNM side secondly, we just started launching altamira us an atypical H.U.S. and that's a conversion dynamic that we will see.
Now, there's a mix of both volume as well as price and you have been you can see in the appendix the pricing dynamic so we still expect the conversion.
Dude to drive the volume and there will obviously be some price headwind as a result of the lower annual cost per patient.
That will be balanced by on the Solaris side strong growth on the neurology franchise as well as on the metabolic side, both of which both of those businesses still continue to grow very well.
Yeah, we have a.
One seven the for the quarter. So we have a run rate of 60, we plan to do a much further than that Jeff.
You know, it's almost no it's U verse sales in 2019.
And use this is picking up and Brian was talking about the fact that the it's us conversion tool to mirrors the similar to what we've seen with Pn age which is best in class.
Plus.
We think that were on the good track to get European H. US approval before mid tougher of this year. So there will come in as well was every month, we have another country.
Globally, that's launching a altamira so ultimately is going to gross substantially.
And then with respect to your question on your than launches, yes, So Jeff highest Sean I think the 10 launches is clearly our ambition. We believe it's an achievable ambition five of those launches are related to you all to mirrors, which we think is de risk based on the data we have so far many of those are in disease areas, where we've already.
The establish proof of concept and mechanism. The other five relate to new assets are two of those are our organic copan and in fact study where we think we have strong supporting data and as you indicate we continue to press. The envelope. If you will with regard to business development and bringing in new assets.
That we think we'll be able to kind of plug and play and so we think thats. Some it's highly achievable and if one or more of those fall off than than we have other opportunities as well that we haven't really talked about both internally as well as potentially through external innovation.
Does that answer your questions Jeff.
Next question. Our next question comes from Chris Raymond of Piper Sandler Your line is open.
Yeah. Thanks for taking the question Justin.
Lotus thing in your slides I guess at slide 12, specifically it looks like.
There's a lot more growth in Q4 for ultra mirrors in APAC or the rest of world versus you. Maybe just if you could talk about the assumptions you made in 2020 for.
Europe versus.
First of all the APAC on ultra Myris.
And also maybe can you quantify any Russian bio similar impact.
For for Ultimate Grocers, Solaris and then maybe a hub just a guidance question around you.
On the on the R&D can you maybe put some brackets around.
[music].
What the those milestones.
Our and maybe quantify some of that impact.
Thank you.
Maybe I'll start with Russia as matter of fact, you might know how the Russian market works, but we're out of the C business in Russia should you expect any old to various business in Russia moving forwards the answer is not really.
And on your second question on APEC fourth quarter loading Yeso, the APEC fourth quarter that you see it's really driven by Japan and as we launch.
He NHL comparison, Japan, there was very strong uptake we have share numbers with you in the past and that was the loading does benefit that I talked about for the DNA spatial given given the pricing and the volume difference. So so that explains the.
And then we have a question on the milestones yes. We we you know we've made public our various partnerships both on Caylloma, an antibody and dicer nine so forth and as those programs progress.
They will be they will be milestones old I don't think we're breaking down how much as milestones versus not and then also that 270 million increase includes the impact of the killing on transaction and you can estimates or how much that spend would be given we plan to progress both danica ban and.
Five to two way forward this year.
Okay, we'll take the next question.
Our next question comes from Josh Schimmer of Evercore ISI. Your line is open.
Thanks for taking the question eminent list at both was there any other contributed contributing factors for the strong performances earlier in the U.S., even even with some of that the growth drivers that store a little bit above where it might have expected and then for soliris in Japan.
With the new repricing rural with label expansion Duffy and demo.
Hi indication addition.
Is that going to change the price point for Solaris Bluesoho. Thank you.
Hi, Josh it's Brian .
With us Soleris in the US I think what you have our mostly as a story around neurology and we're really pleased with the growth that we've had with GM G.
As well as the launch event Immodesty, which again began in July and that is progressing very nicely. We also and this is more for Solaris and ultra mirrors, which goes back to earlier questions as well. In addition to all the conversion dynamics that we talk about we continue to identify new.
Naive patients with P., NHS wallasey, typically to us as well and as we've indicated we see that continuing in high single digits in low double digit growth pattern. So that's that's feeding it. Additionally.
Okay, we'll take the next question.
Our next question comes from Matthew Harrison of Morgan Stanley . Your line is open.
Hi, This is cost us on for Mark you I have a question based on your Ftn DMT study, which is now a phase two in the second half 2020 I'm wondering whether that has been any delay to the initiation of beside the values.
Versus prior expectations and follow up question, what do you need to advance the study to the phase three thank you.
Just thank you.
So we have to anti R. CRM programs one is.
Via this continuing acquisition, which is 18 30, that's back in the clinic now you may recall that last year, we had CMC issue that we've addressed we had now have new drug product. That's been delivered we initiated with a higher concentration formulation subcutaneously onto healthy volunteers that began in December .
And we're re initiating a phase two program with the Ivy formulation and hemolytic anemia. This quarter, which was also pause for the same reason so we will complete those.
Dose ranging trials and then.
In a position to launch pivotal programs later this year and in a with regard to to my senior Gravis, we may need to do some additional dose ranging upfront there that would be a seamless phase two three type of trial and then of course progressing further with hemolytic anemia.
So no no additional delays in the program, where we're pressing ahead.
Next question.
Our next question comes from Robyn Karnauskas of Suntrust Robinson Your line is open.
Hi, Thanks for taking my question and I would just quickly on the 20000 eligible target population for energy that you've noted.
How are you thinking about that in terms of that impact to price.
And and the ability to capture that given the competitive landscape and along with that you've talked about you have a way to go still with converging heard at 60%, 70% you set out originally as a goal how do we think about bottlenecks for conversion coating forward, how quickly could that flow or just any.
Color you can revise that we could figure out how they had a model that correctly. Thank you.
I Robyn, let me start with the first one on the the approximately 20000 patient addressable opportunity for Ulta mirrors in gmg.
So the way the we see the gmg market evolving is first of all.
As we've talked about many times soleris continues to occupy.
Relatively let's call. It narrows segment of the larger gmg populations about 8000 patients, which are uncontrolled more severe patients and that really aligns with the regain pivotal phase three study.
We're not by the way limited from a label perspective to stay in that 8000 patients, but that has in the last two years, that's really been the sweet spot for Soleris as we move into the opportunity with the launch of Ulta Myris based on the trial design that John and the team have put.
Forward, we see that that space expanding such that the burden of previous is t. cycles of therapy is not as high as it was for regain and we see that opening up a larger.
Segment for all to mirrors.
Now to your point about price.
I mean neurology is one aspect of price that we'll continue to assess but as we've said we have eight indications that we've announced that we're pursuing for all to mirrors and as those unfold. We have consistently said, we maintain price flexibility to align the volume opportunity with the value that ultimately.
The offers and so we'll we'll stay on that path.
Your second question was around the continued conversion dynamics, we still maintain the same ambition of 70% within two years of our launch markets. We're well on track with that we've talked with a lot of pride about the three largest markets we have worldwide Us Germany, Japan.
The only real bottlenecks that we see and I wouldn't even call and bottlenecks. It's largely a function of time is moving from so called centers of excellence of treatment with Pn age higher volume centers.
As well as with the typically choose to a broader customer segment and that just takes time for us to continue to penetrate.
We take the next question operator.
Our next question comes from Mohit Bansal of Citi. Your line is open.
Great. Thanks for taking my question.
Yes.
Switching to alert the identical and as that private to eight strategy.
The Doctor testing like Bill alternative back log and for 4001 is clearly not as clean water therapy.
Could you. Please help us understand what would you want to see Wi Fi to weight in terms of profile of the Doug.
Actually make it a viable that'd be potentially of frontline either ahead of the five thank you.
Yes, sure. So first of all we're committed to progressing the clinical development plans that are killing on has already communicated publicly MPN age with 4471. That's completed the phase two data that were shared at Ash in December and now planning to move forward with a phase three study and ph patients with that extra vascular mosses.
At the same time, there is an ongoing phase two study with five two to eight which has better PK characteristics. It is got to longer half life. The applet being about 12 hours on it also has better activity against the alternative pathway with more than 90% inhibition of that pathway. So we're really excited about that compound.
In order to give it less frequently and its greater potency that allows us to expand potentially into new opportunities.
Opportunities beyond those with the EPA. So there was a phase two program going on now that is looking at it not only on top of C inhibition, but also as monotherapy.
And then I would say lastly that we're very excited about the opportunities beyond PNM range and additional disease areas that we havent operated in where the alternative pathway has been implicated in where they are exciting opportunities to treat more patients with rare disease.
Got it has taken last question.
And our last question comes from Kennen Mackay of RBC capital markets. Your line is open.
Hi, Thanks for squeezing me in and congrats on the progress throughout 2019 and into the new year, maybe a question for Brian teenage switch execution has been beyond phenomenal in in the U.S can you maybe help us understand how we should be thinking about the pace of switching off versus damage during different food and presentation and reviews more.
Good.
Yes, Hey, Ken and beyond phenomenal I wrote that one down so thanks a lot.
Right.
Annual review.
Yes.
The dynamics as I noted earlier the dynamics between typically two S&P and HR different but the of course the profile of Ulta Myris is the same and and we get the same compelling feedback from patients from physicians and certainly from payers and in fact as a Rodman had noted the.
Economics on an annual cost of therapy play out even more favorably for atypical issue us.
With Ulta Myris versus Soliris, So I think what we're going to see our different dynamics in terms of inpatient outpatient starts, but this seems 70% ambition in and just a couple of months into launch we're pleased with how we're tracking so thanks for the question.
Okay perfect.
Operator.
I'll take it from here I have two topics that.
I want to close the the missing.
With the first topic is the state of a business the second one isn't updates on IP.
With respect to our business I believe we have a very healthy business. We talk about the fact that we have a healthy topline growth moving forwards.
In the driven by volume growth. This is not about price increases, we travel business through through volume and innovation.
We believe we have a healthy R&D pipeline.
And Thats why we say we we are ambition is to launch then products new indications new formulations by 2023 and.
And thats the way it should be for abide tecogen position.
Then.
We have an operating margin that is very attractive within our industry. We know around the mid Fiftys, we come from the low Fortys and we believe that's a very healthy operating margin space to play in so we really feel good about all of this and this is reflected.
In our guidance.
The second.
Topic as I said is IP, so I have an update and some of you might have seen that the U.S. Fenton office has the low it's a new patent for Soleris.
Providing additional patent protection in U.S. true 2027.
And a new patent covers and methods of treating ph would solaris, which is a method of use patents.
Just to remind you. We also have an existing patent covering a method of use for hqs with Solaris, which expires in 20 to 32.
None of those two patents have been challenged.
It's important that you guys know all the details of what's going on in the in the U.S. patent office.
With that.
We'll close the call. Thank you for dialing in them real excited about the progress that we're making and hope you will enjoy the rest of your day. Thank you.
Ladies and gentlemen, this does concludes the conference call. Thank you for participating you may now disconnect everyone have a great day.
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Hi.
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