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Alexion Pharmaceuticals Inc (ALXN)
Q2Â 2019 Earnings Call
Jul 24, 2019, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning, and welcome to the Alexion Pharmaceuticals Incorporated Conference Call to discuss Second Quarter 2019 Financial Results. Today's call is being recorded. For opening remarks and introductions, I would now like to turn the call over to Susan Altschuller, Vice President of Investor Relations. Please go ahead, ma'am.
Susan Altschuller -- Vice President of Investor Relations
Thank you, Crystal. Good morning, and thank you for joining us on today's call to discuss Alexion's performance for the second quarter of 2019. Today's call will be led by Ludwig Hantson, our CEO. Ludwig will be joined by Paul Clancy, our Chief Financial Officer; John Orloff, our Global Head of R&D and Brian Goff, our Chief Commercial Officer. You can access the webcast slides that will be presented on this call by going to the Events section of our Investor Relations page on our website.
Before we begin, I would like to point out that we will 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 SEC 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 will be using non-GAAP financial measures, which we believe provide 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 measures should be considered in addition to, but not a substitute for, our GAAP results.
Thank you. Ludwig?
Ludwig Hantson -- Chief Executive Officer
Thank you, Susan, and good morning, everyone. We have made great progress so far this year further solidifying the durability of the base business in PNH and aHUS continuing to drive neurology and metabolics growth building out the pipeline for long-term value creation and continuing to deliver on our financials.
Slide 5 highlights some of our recent achievements. The US launch of ULTOMIRIS with PNH is off to a strong start. And I'm pleased to report that as of the beginning of this week, we have facilitated conversion for 40% of PNH patients. On July 2nd, we received approval of ULTOMIRIS of PNH in the EU and have already launched in Germany. We have remained consistent with our global sustainable pricing strategy and have a best-in-class conversion ambition of at least 70% of patients in the first two years from launch.
Our ULTOMIRIS atypical aHUS filing was accepted by the FDA and granted priority review with a target action date of October 19, ahead of our initial expectations. With the US approval of SOLIRIS in NMOSD in late June, we took a major step forward in neurology. SOLIRIS is the first ever FDA approved therapy for NMOSD, a disease in which even one relapse can have a devastating consequences for patients.
We have already made good progress with the US launch and are working on pre-launch plan in the EU and Japan where we hope to gain approvals by the end of the year. With the launch of NMOSD and growing contribution from gMG, we expect neurology to be our biggest franchise by patient volume in the US by year-end.
In metabolics, STRENSIQ and KANUMA once again delivered double-digit year-over-year growth, with 1840 for Wilson disease. We have an opportunity to bring another transformative therapy to patients and our pivotal trial remains on track to complete enrollment by early next year.
Our pipeline is progressing. Dosing is under way in the Phase 3 studies for ULTOMIRIS subcu and ULTOMIRIS in gMG. We are also preparing for multiple late stage clinical trial initiations over the coming year. Business development remains a core organizational focus, that we are working to add to the three deals completed in the first half of the year: Caelum, Affibody and Zealand Pharma.
Finally, we delivered very strong financial performance with 15% revenue growth and 28% non-GAAP EPS growth. And our updated 2019 guidance reflects the momentum of the business. All this positions as very well to deliver against our objectives in the remainder of the year. We also continue to look for opportunities to further build out our core therapeutic areas and expand into orders, aligns with our mission to bring transformative therapies to even more patients with rare diseases.
With that, I will turn the call over to Paul to discuss our second quarter financial results. Paul?
Paul Clancy -- Executive Vice President and Chief Financial Officer
Thanks, Ludwig. Starting with Slide 7, we reported second quarter total revenues of $1.203 billion, an increase of 15% year-over-year. This was driven by gMG, continued growth in the core business and the ULTOMIRIS PNH conversion.
Our non-GAAP operating margin was 58% in the second quarter an expansion of 417 basis points, driven by top line leverage in lower than planned R&D expense. Non-GAAP earnings per share was $2.64, representing 28% growth year-over-year.
Moving to Slide 8. Second quarter net product sales were driven by volume growth of 23% offset by an FX headwind of 1% in a price headwind of 7%. The price headwind was largely a result of $32 million reduction to revenue for SOLIRIS in our Canada business in the second quarter. This is related to our ongoing dispute with the Canadian Patented Medicine Prices Review Board or PMPRB related to several SOLIRIS pricing in Canada. In May of this year, the Federal Court of Canada dismissed our application for judicial review. While we are appealing the decision led to a reduction of revenue in the quarter, which includes the impact for the period from September 2017 to June 2019. We estimate that going forward, this will result in approximately a $5 million headwind per quarter.
Turning to Slide 9, SOLIRIS revenue in the second quarter was $981 million with year-over-year volume growth of 17%. Revenue growth in Rest of World markets was negatively impacted by the Canada judicial order in erosion in the Russia business. In the US, we benefited from order timing ahead of the July 4th holiday by approximately $8 million, which is consistent with prior year.
Turning to Slide 10. ULTOMIRIS revenue in the second quarter was $54 million. Recall is patients switch there is a 10% benefit in the first year due to the loading dose dynamic.
On Slide 11, we've included the C5 franchise of SOLIRIS and ULTOMIRIS combined where we saw 15% year-over-year growth across PNH, atypical HUS and gMG. Underlying volume growth in PNH and aHUS remains solid in the quarter and we expect high single-digit underlying volume growth for the year for those two indications.
Moving to Slide 12, STRENSIQ revenues for the second quarter were and $141 million representing 13% revenue growth in 21% volume growth year-over-year. KANUMA revenues in the second quarter were $26 million representing 22% revenue growth in 33% volume growth year-over-year.
Turning to the P&L on Slide 13. During the quarter, non-GAAP R&D expense was $149 million for 12% of revenues. Our non-GAAP R&D expense is much lower than we had planned. This is due to the phasing of late-stage program spend, which we expect to ramp up in 2020, and we've not seen significant R&D burn from the business development deals we've closed so far this year.
Non-GAAP SG&A expense was $256 million or 21% of revenues. The non-GAAP effective tax rate in the quarter was approximately 13%, the GAAP tax rate was 8% both non-GAAP and GAAP taxes were driven by our ability to claim a foreign tax credit in the quarter. We reported second quarter non-GAAP earnings per share of $2.64 growing 28% year-over-year. GAAP earnings per share was $2.04. We ended the second quarter with approximately $2.1 billion in cash and marketable securities.
I'll now turn to Slide 14, for our updated full year financial guidance. We're guiding to total revenues between $4,750 million to $4,800 million, an increase from prior guidance. This represents 16% growth year-over-year at the midpoint of the range. For the combination of SOLIRIS and ULTOMIRIS our revenue guidance is $4,095 million to $4,130 million. This assumes continued momentum in gMG incorporates our recent launch of NMOSD in the United States. And now includes the expected of FDA approval in US launch of ULTOMIRIS for aHUS in the fourth quarter.
Turning to metabolics, our revenue guidance is $655 million to $670 million for both STRENSIQ and KANUMA. This includes the impact of a strategic pricing decision for STRENSIQ in the US to support sustainability given weight based dosing. We estimate price will be a 3% headwind in 2019, higher than prior guidance driven primarily by the Canada pricing item. Foreign exchange impact net of hedging is expected to represent a $40 million headwind. GAAP operating margin is expected to be between 42% and 43% inclusive of restructuring and related expenses as well as upfront payments.
Non-GAAP operating margin is expected to be between 55% to 56% of revenue. Non-GAAP R&D expense is it projected to be 14% to 16% of revenues, lower than our original expectations for 2019. Phasing has shifted and we now expect much of the late-stage program spend to accelerate into 2020. We intend to further build the pipeline and anticipate R&D spend both in dollars and as a percentage of sales to increase going into next year.
Non-GAAP SG&A spend is expected to be 20% to 21% of revenues for full year 2019. We expect non-GAAP effective tax rate similar to 2018. GAAP earnings per share is expected to be between $8.13 and $8.41 and non-GAAP earnings per share is expected to be between $9.65 in $9.85. The midpoint of this range is approximately 23% growth year-over-year. We've delivered an excellent first half in well positioned to deliver on our 2019 financial goals.
I'll now turn the call over to John to provide an update on R&D.
John Orloff -- Executive Vice President, Head of Research and Development
Thank you, Paul. I want to start by recognizing the significant accomplishments of the R&D organization in the first half of this year. SOLIRIS became the first FDA approved therapy for NMOSD marking a significant milestone in the treatment of this devastating rare disease. ULTOMIRIS was approved for PNH in both the EU and Japan and granted priority review for atypical HUS in the United States. We continue to advance our pipeline and our dosing patients in our pivotal ULTOMIRIS gMG trial as well as our once-weekly ULTOMIRIS subcutaneous trial.
We also added to our pipeline with three business development deals. We announced the collaboration with Caelum Biosciences for CAEL101 and AL Light Chain Amyloidosis; a collaboration with Affibody Biosciences for ABY-039 and novel Anti-FcRn asset; and a collaboration with Zealand Pharma for peptide therapeutics targeting complement.
On Slide 17, you can see the breadth of our development portfolio, which currently encompasses 15 development programs across our four blockbuster pillars. We expect clinical trial activity to ramp up toward the back half of 2019 and into 2020 as we initiate numerous late-stage development programs.
Turning to Slide 18, I'd like to highlight some of the key late-stage programs, starting with our plans for ULTOMIRIS in hematology and nephrology, we are announcing today that we plan to initiate a Phase 3 study in Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy or HSCT-TMA in 2020. This provides us the opportunity to potentially serve HSCT-TMA patients. We have very limited treatment options.
With our ULTOMIRIS once-weekly subcutaneous Phase 3 study, we believe we will be able to offer optionality for patients with PNH and atypical HUS. In neurology, our Phase 3 study of ULTOMIRIS and gMG is ongoing, with plans to pursue a weekly subcutaneous bridging strategy in parallel. We are on track to initiate a Phase 3 trial for ULTOMIRIS and NMOSD later this year. We plan to initiate a clinical trial in ALS, early next year pending regulatory feedback. This would likely be a Phase 2/3 study with a goal to gain early proof-of-concept for the role of complement inhibition in the pathogenesis of ALS.
Moving to CAEL-101, in our collaboration with Caelum Biosciences. The plan to initiate a Phase 2/3 study in early 2020 in patients with AL Light Chain Amyloidosis, a rare disease with rapid progression to organ failure and high mortality. Recall the Phase 1a/1b program demonstrated early proof-of-concept with clinical benefit on cardiac and renal function and target engagement in vivo.
Turning to metabolics with ALXN1840 for Wilson Disease. We remain on track to complete enrollment in our Phase 3 trial early 2020. 1840 has the potential to be highly differentiated from current therapies due to a 10,000-fold higher affinity for copper potentially improving liver function and neuropsychiatric symptoms and significant improvement in dosing.
Finally, ALXN1840 [Phonetic] is our lead candidate in our emerging anti-FcRn portfolio. We remain on track to manufacture sufficient supply for the 1830 [Phonetic] clinical programs by year-end. In warm autoimmune hemolytic anemia, we plan to start a Phase 2/3 operationally seamless trial of 1830 in early 2020.
In gMG, given the evolving landscape, we have decided to focus our development of 1830 on a subcutaneous formulation and we'll begin a trial in 2020 [Phonetic] after generating subcutaneous data in healthy volunteers.
I'm incredibly proud of the progress made so far this year and we'd like to thank the global R&D organization for their tireless efforts in advancing our pipeline and portfolio strategy. I look forward to providing future updates as our pipeline continues to build.
With that, I'll turn the call over to Brian to discuss commercial highlights for the quarter. Brian?
Brian Goff -- Executive Vice President, Chief Commercial Officer
Thanks, John. I'll start on Slide 20 with all the progress we've made with ULTOMIRIS. In the US, we continue to be very pleased with the launch in our efforts to facilitate patient conversion. As of the beginning of this week, 43% of PNH patients were enrolled in OneSource and 40% are on treatment with ULTOMIRIS. So we remain on a very solid path toward achieving our goal of best-in-class patient conversion and now believe we can reach that goal of at least 70% even faster targeting mid-2020 in the United States. This is not only important for patients, but also reflects the strength of the ULTOMIRIS [Technical Issues].
Earlier this month, we received approval for ULTOMIRIS in Europe and have already begun treating patients in Germany, where we have a sustainable pricing strategy as is already established in the US. Similar to the global price range for SOLIRIS our ambition is to maintain a relatively narrow price band globally for ULTOMIRIS. We aspire to facilitate a rapid best-in-class conversion in each launch geography.
In Japan, we received approval in June and while we're waiting for the National Health Insurance price listing in order to launch. We're actively engaged in efforts to improve physician awareness of ULTOMIRIS. We anticipate patients can begin conversion in September.
Turning to Slide 21, neurology represents a significant growth opportunity. As you see on the left, we ended the quarter with nearly 1,200 gMG patients treated with SOLIRIS in the US and we're still less than two years into the launch. On the right, you can see the continuum of gMG disease severity. Building on our base of SOLIRIS, our goal is to expand treatment options for gMG patients with ULTOMIRIS ALXN1830 [Phonetic]. We believe a portfolio approach will help us to serve patients across the spectrum of disease.
Turning to Slide 22, we're excited to build upon our gMG success with the recent expansion of SOLIRIS into NMOSD. SOLIRIS is the first ever FDA approved therapy for NMOSD, a disease in which patients live in constant fear of the unpredictable and potentially devastating effects of another attack. As you can see on the right, our Phase 3 trial demonstrated that SOLIRIS has a profound effect on reducing the risk of an NMOSD relapse. We've expanded our neurology field in medical teams this year, which positions us well for launch. There are strong synergies and overlap with gMG, but we're also targeting new call points such as MS centers of excellence. With the right infrastructure in place and a sense of urgency to serve these patients, I'm pleased to report that we already have a number of open cases in OneSource as well as the first NMOSD patients now treated with SOLIRIS.
Moving to our metabolics franchise on Slide 23. We reported second quarter STRENSIQ revenue of $141 million with our CALIPER each adjusted initiative we aim to increase awareness and adoption of the appropriate diagnostic ranges for HPP, helping to support earlier diagnosis, particularly of pediatric patients.
KANUMA ended the quarter with revenue of $26 million with both LAL-D and HPP, we continue to identify new patients and plan to seek reimbursement agreements in additional geographies. This was a great and action packed second quarter, and I want to especially thank the commercial team for their hard work and dedication to bringing hope to patients suffering from our now expanded rare disease indications.
I'll now turn the call back to Ludwig for closing comments. Ludwig?
Ludwig Hantson -- Chief Executive Officer
Thank you, Brian. I'm very pleased with our 2019 progress so far. I look forward to further building on this momentum. As we strengthen our position in each of our four blockbuster pillars, we also continue to look for ways to further leverage our unique and established rare disease expertise.
Looking ahead, we have a strong foundation with our base business and exciting opportunities for growth, including our expanded neurology portfolio and numerous late-stage pipeline programs. We're committed to executing on our strategy with the aim to transform patient lives and create long-term shareholder value. As always, I would like to thank our global employees for their dedication to our mission and the patients we serve for their continued trust in us.
With that, we will now open the call to questions. Operator?
Questions and Answers:
Operator
[Operator Instructions] And our first question comes from Geoffrey Porges from SVB Leerink. Your line is open.
Geoffrey Porges -- SVB Leerink -- Analyst
Thank you very much and congratulations for all of you on the progress and particularly the approvals. I guess the big question, Ludwig, is the -- that the share price. You're executing strongly both in the pipeline and commercially the trajectories are looking good for the new products and new indications. But yet the share price has been flat for three years. And that probably reflects people's concerns about pricing, patents and concentration of the portfolio. So as you think about more options you might have with the company. Is there anything that you could contemplate that might potentially generate value for shareholders or else things you could do with the balance sheet? And assuming that there's not much you can say about that, could you just also update us on the EU patent appeal as well, which is part of the other hand?
Ludwig Hantson -- Chief Executive Officer
Yeah, we have a lot of questions in there, Geoff. But, thanks. Thanks for that. So first of all, we are -- we have a strong strategic plan and the team is doing an awesome job in executing the plan here in. When you look at our business model on where we were a couple of years ago, and where we are now, I think the team is really redefines what the fundamentals of this organization is. And we're growing from old to new, and it's only like year-and-a-half ago that we've got the ULTOMIRIS data, which was strong. We're moving our business from of SOLIRIS to ULTOMIRIS business, with respect to some of your questions on concentration IP by similar.
As we execute or continue to execute on our conversion, those questions are going to become less relevant. Because biosimilars in IP is related to the SOLIRIS story, not related to the ULTOMIRIS story. And as we're building that conversion quarter-after-quarter, country-after-country, we're going to have a new portfolio that will raise different type of discussion.
So I'm really pleased with what we've done so far. We're not going to change our strategy. As I said, we believe we have a very strong strategy. We're looking at strengthening our portfolio through internal innovation and as you saw that we have 1720, which is internal assets of first one in the last two years going into CTA as well as we will continue to use our cash toward building our pipeline through external innovation.
So I think, my story is, we don't change this company overnight. The team has a very strong strategic plan, we're delivering on what we said, we were going to do. And every quarter we're getting stronger and stronger with our fundamentals.
With respect to your questions on IP, there is no new news on the EPO. In Europe, no new updates. So beginning of September we should know more about composition of matter and matter of use patents. But again, a come back to what I just said, that is our strategy, our chapter 2 for this company is to make ULTOMIRIS the standard of care for PNH and once approved the standard of care for aHUS. So the topic of IP and biosimilars will become less relevant for this organization.
So I hope that answers your question. I'm looking my colleagues to see if further anything you want to add to that.
Paul Clancy -- Executive Vice President and Chief Financial Officer
No. Well said.
Geoffrey Porges -- SVB Leerink -- Analyst
Okay. Thanks, Ludwig.
Ludwig Hantson -- Chief Executive Officer
Thanks, Geoff.
Operator
Thank you. Our next question comes from Matthew Harrison from Morgan Stanley. Your line is open.
Matthew Harrison -- Morgan Stanley -- Analyst
Great. Good morning, and thanks for taking the question. I guess I wanted to focus on a couple of the R&D programs if I could, and just ask about especially timelines related FcRn, it looks like those studies are now starting a bit later than you had talked about last quarter and so. I was wondering if you could update us on the manufacturing issues that you had and if you've been able to work through those and then what some of the drivers have been around the pushing out at the timeline related to those? Thanks.
John Orloff -- Executive Vice President, Head of Research and Development
Thanks, Matt. This is John. Actually no change relative to what we communicated last quarter. We basically what we said and what we've identified is an impurity in the manufacturing process that we've addressed now. And we've run new drug substance runs that will deliver new drug product by the end of the year. So drug product will be delivered by December, which allows us to restart the program in January. So that's consistent with what we said. We do plan to go back into hemolytic anemia with a Phase 2/3 operations seamless design with the IV formulation. We're also pursuing a subcu formulation with higher concentration drug product that will also be delivered at the end of the fourth quarter for us to start dosing healthy volunteers.
And then, as I indicated in during my prepared comments, we are looking at Myasthenia Gravis as well with that subcu formulation recognizing evolving landscape in that space. And I will take the opportunity to say that we are committed to Myasthenia Gravis. We clearly have gone great product in severe patients with severe gMG [Phonetic] with SOLIRIS. We're conducting a trial now with ULTOMIRIS in Myasthenia Gravis that does not require the failure of an IST, so to move further upstream in the patient journey less severe patients. And then with our FcRn, we have few shots on goal here. We have ABY-039 is in Phase 1 dosing now as SAD and MAD, as well as our 1830 that will give us the opportunity to span the spectrum of all patients with Myasthenia Gravis.
Operator
Thank you. Our next question comes from Chris Raymond from Piper Jaffray. Your line is open.
Chris Raymond -- Piper Jaffray -- Analyst
Hi. Thanks. Just another R&D question, I guess. Just one, really just. I wonder if you could talk a little bit about what's going on with ALXN1810. I think last quarter you talked about completing a Phase 1 study. And I think you even had a slide talking about a potential launch in 2023. But as I read the description now looks like you're in the midst of strategic planning for that asset. So is this some driven by what you're seeing with ULTOMIRIS subcu or is there something else going on with 1810? Thanks.
Ludwig Hantson -- Chief Executive Officer
So, as you know, for 1810 we've completed the healthy volunteer study that allowed us to increase the bioavailability from 60% for 1210 which is ULTOMIRIS to 73%, which gives us options to dose at every two weeks. We are looking at our options here given the fact that ULTOMIRIS now is rapidly expanding to now seven [Phonetic] new indications in total with PNH and atypical HUS, it's serving that patient popular -- those patient populations very well. In parallel, we have a subcu program that's enrolling now that will allow optionality for patients in our core business when that reach out in 2021, and it gets to market. And we have a bridging strategy to expand that once weekly subQ formulation to the other indications we're pursuing with ULTOMIRIS. So right now we have options in our portfolio with regard to C5 that include 1720 as well as 1810 we're exploring now the potential to go into alternative indications and go into new horizons.
Chris Raymond -- Piper Jaffray -- Analyst
Thank you.
Operator
Thank you. And our next question comes from Martin Auster from Credit Suisse. Your line is open.
Martin Auster -- Credit Suisse -- Analyst
Hey, guys, thanks for taking the question. Congrats on the continued strong operating results. I have a follow-up on the Canada pricing decision. I was just curious -- so does the lowering of Canada prices where you had presents any near-term risks as it creates a lower price point that could then be used by as a competitor by other countries that are evaluating pricing or on SOLIRIS? So just curious that would trigger potentially in near-term risks around other countries repricing SOLIRIS.
And then secondly, I was wondering if you could articulate more precisely what the international pricing vendor on SOLIRIS is? And then for ULTOMIRIS, do you expect a similar pricing band or relatively tighter international band when you currently have with SOLIRIS? Thanks.
Paul Clancy -- Executive Vice President and Chief Financial Officer
All right, Martin. This is Paul. Thanks for the question. The Canada situation goes back to kind of 2017, as I had noted, it's been our legal disclosure since that time period. We believe it's pretty localized issue. It relates to what the core issue relates to -- what's the appropriate comparison and it actually gets involved with foreign exchange rates and so on and so forth. We're appealing it, but for the time being, there'll be a little bit of a headwind as we kind of march through the balance of the year. But we do believe it's local -- it's a localized issue at this point, Brian?
Brian Goff -- Executive Vice President, Chief Commercial Officer
Yeah. And just on the second question about the SOLIRIS pricing band. We haven't quantified that, but I mean, qualitatively we've described it as a relatively narrow global pricing band. And I think that's really relative to what we know in terms of most other pharmaceutical products on the market who have a global footprint similar to ours. So the ambition that we have, and we've already taken big steps toward this with the launch of ULTOMIRIS in the US, and then most recently in Germany is with ULTOMIRIS. We want to have maintained a similar pricing range. So in Germany, just to be specific about what that looks like, it is similar to the pricing in the US. And so in the maintenance fees, there is about a 10% discount of ULTOMIRIS versus SOLIRIS. The way, Germany looks at these patients is they have kind of more of a longer-term view they blend together years one and two. And when you take that average there is essential parity with ULTOMIRIS versus SOLIRIS. And then when you get into maintenance and beyond. You capture the system savings of the discount and that's our ambition to have that pricing range globally.
Ludwig Hantson -- Chief Executive Officer
Yeah, I'm going to add to this. The government published end of 2018 a international pricing review.com and SOLIRIS as part of this. So maybe that's a good reference document. But what it said is that our SOLIRIS price in the US is not that much different from the price you're going to see Internationally. And maybe you have already seen this document.
Martin Auster -- Credit Suisse -- Analyst
Thanks. That's very helpful color. Appreciate it.
Paul Clancy -- Executive Vice President and Chief Financial Officer
Okay. You bet.
Ludwig Hantson -- Chief Executive Officer
Take the next question.
Operator
Thank you. Our next question comes from Paul Matteis from Stifel. Your line is open.
Nate -- Stifel -- Analyst
Hi. Thanks for taking the question. This is Nate [Phonetic] on for Paul. Maybe one question for Brian. So you've got almost 1,200 gMG patients on SOLIRIS. Well, I guess two: a, how is persistent and book so far. And then b, just longer term. What do you think taps the upside of SOLIRIS in gMG. Is this, I mean, by that, is this payers restricting use or do you think is going to be physicians being reticent to use that in a lesser refractory population? Thanks.
Paul Clancy -- Executive Vice President and Chief Financial Officer
Sure. Well, we are really pleased with the progress that we're making. So we're nearly two years into launch and we've been very consistent reporting the numbers. So you guys can see exactly what we see and we continue to make progress with all the stakeholders, whether it's physicians, patients or payers. Just to quantify where we are in the bigger picture in the US gMG, refractory population, which really aligns with our regain pivotal Phase 3 study at the high end of that there were about 8,000 patients. And as you just noted, we have now achieved nearly 1,200, but that's still is a pretty small number in the bigger picture, which suggests there is plenty of opportunity to go.
I think most importantly, in terms of how we continue on that journey. It's really clear that SOLIRIS continues to deliver clinically, and we see that reflected by the steady growth as well as particularly at this stage in launch both breadth of prescribing as well as depth of prescribing and both of those components for all of our launches are important measures. So what this does is this reinforces at the physician level, their advocacy to payers. So if the payer were to come back to a physician and require some form of documentation for continuity of therapy that reinforcing clinical delivery that SOLIRIS is offered has only strengthen the case.
And then I would add that, from a payer perspective to where we are with now both gMG and NMOSD is that we continue to reach out to payers proactively in the combination of that proactive communication as well as the steady growth creates one of the most important elements for payers and that's predictability as they set their budgets going forward. So we feel really good about the progress.
Operator
Thank you. Our next question comes from Phil Nadeau from Cowen and Company. Your line is open.
Phil Nadeau -- Cowen and Company -- Analyst
Good morning, thanks for taking my question and congrats on the progress. Just a couple around the European patent situations. Our understanding is that the, on September 5th the Board will issue a ruling on the two patents on that day. Is that correct? And if it is correct, we'll Alexion be in a position to announce what the ruling is on September 5th or you have to wait for some written correspondence.
And then second, broadly in the European situation if you don't successfully get those patents issued, the concern that we continue to hear is that biosimilars should they launch in Europe would not just compress the price of SOLIRIS, but would have some impact on the utilization and pricing of ULTOMIRIS and price sensitive countries? What do you think of that concern? Is there a chance that deeply discounted SOLIRIS biosimilar could impact utilization or pricing of ULTOMIRIS in European price sensitive countries? Thanks.
Ludwig Hantson -- Chief Executive Officer
Yeah. So with respect to the EPO hearing, correct at September 5th, so no new updates there. And yes, it is about two patent applications which is composition of matter. And noted of US, this is a closed hearing and we think that's a written decision would come soon after. But we expect to know the outcome of the completion of the hearing, the outcome at the completion of the hearing. So this will be on the same day. And with respect to what it means for the European situation, a couple of things. First of all, as you know, we have the formulation patent granted, and we have an appeal process ongoing. So that means that, that patent is going to stick with us after next three to five years, that's Number one.
Number two is, our strategy is to make ULTOMIRIS the standard of care for PNH. And as I said once approved those will standard of care for aHUS. And with the approval and the launch in Germany, we have -- we feel we have a time enough to convert a business to second-generation, so which is ULTOMIRIS. The timelines for biosimilars to the best of our knowledge. We think best case scenarios is three years from now. And I think, we can do a lot of conversion and upgrade standard of care or redefine standard of care in the next three years.
Which respect to interchange ability of ULTOMIRIS and SOLIRIS, these are two different molecules in -- I'm not aware of a market and a lot where biosimilars is moving into a branded product. So if you have market analogs in Europe, please [Indecipherable] to that, I can learn, but I'm thinking of older biosimilar launches in Europe in the market dynamics in each of these countries. This will be two distinct molecules and two distinct pricing dynamics.
So I'm looking at Brian here.
Brian Goff -- Executive Vice President, Chief Commercial Officer
Yeah, I would just only add that, if you stick to that timeframe three years from now and the ambition that we have with ULTOMIRIS, facilitated patient conversion. It gets harder and harder to imagine that you have patients who have had repeated by monthly infusions in the experience that comes with that, that we've already seen play out in the US. It's hard to imagine that those patients would then or the physicians would be motivated to take a step backwards to go back to biweekly therapy. So the more that we continue to deliver on that facilitated conversion, the better off our position is in the less relevant the prospect of a biosimilar becomes.
Ludwig Hantson -- Chief Executive Officer
Yeah, I think every quarter we are in a much better situation now, since we have the approval. We starting with the conversion. We have good uptick in US and we hope to do the same in Europe. Next being aHUS, there is a lot we can do in three years. And I do believe that we have the opportunity to really redefine standard of care for PNH and HUS and make the IP discussion and good [Phonetic] point. So we'll take next question.
Operator
Thank you. Our next question comes from Kennen MacKay from RBC. Your line is open.
Kennen MacKay -- RBC Capital Markets -- Analyst
Hey, thanks for taking the question. Maybe one for John Orloff. I was wondering if you could just help us understand the decision behind starting the trial in thrombotic microangiopathy HSCT-TMA. Isn't there already some off-label use of SOLIRIS here it is? The decision to run the trial here based on competitive dynamics with other complement inhibitors or just any color there would be hugely appreciated? And maybe a follow-up for Ludwig on strategy, which was brought up previously. I was wondering if there is any potential or thinking around issuing, perhaps a very small dividend. I know this is going to give me some looks from my biotech peers or premyopically [Phonetic] focused on growth, but this really could broaden the shareholder base given some investors might be interested in the story, but they might be precluded from investing if there is on has a mandate for cash return. Thanks so much.
John Orloff -- Executive Vice President, Head of Research and Development
So I'll start with first one. I think we're looking at this is a significant new opportunity in a severe and devastating disease that currently doesn't have really any treatment options. As you may know, HSCT-TMA was excluded from our atypical HUS program, even though many of these patients actually have underlying complement dysfunction. There are approximately 20,000 patients undergoing such transplants in the US annually. 30% to 40% of those experience of TMA event, and about half of those are considered severe related to complement dysregulation and you alluded to SOLIRIS -- actually published case series [Indecipherable] and others that have shown a benefit of SOLIRIS in this population with the reductions in TMA and improvement in mortality, improvement in survival. In fact, the mortality rate is over 80% at one year and in that paper, they had about 60% survival after a year. So it's a reason to believe that we understand the mechanism of action and there is an opportunity here to have a real big impact and yet another indication for ULTOMIRIS.
Paul Clancy -- Executive Vice President and Chief Financial Officer
Hey, Kennen. This is Paul. I'll grab the strategy or capital allocation question. It is -- our priority is strategic deployment, so building the pipeline, I think we've been -- we've tried to be very, very clear about that, that is our priority at this point in time. We're obviously working on the cash flow generation of the company, so that we could potentially broad note, kind of capital allocation and possibly in a few years return capital to shareholders. I think the way we think about it, particularly with the volatility in the sector is that, if we get to that point in time, share repurchases would be the preferred avenue for doing that. So at this point, dividends is not on the horizon.
Ludwig Hantson -- Chief Executive Officer
Yeah. We still have work to do on the pipeline. So that's our main focus at this point. We'll take next question.
Operator
Our next question comes from Mohit Bansal from Citi. Your line is open. Please check that your line is on mute.
Mohit Bansal -- Citigroup -- Analyst
Sorry. Thanks for taking my question, and congrats on all the progress. Maybe one quick question on PNH conversion. Is it possible for you to characterize the early adopters or early switchers in that market? What I'm trying to understand, is it coming more from the bucket of optimal responders on one end of the spectrum or these are the previous who are responders on SOLIRIS? And then going forward, what challenges do you feel from the 40% number to move from 40% to 70% or even beyond that? Thank you.
Brian Goff -- Executive Vice President, Chief Commercial Officer
Yeah. Hi, Mohit. This is Brian. Thanks a lot. Good questions. I would say that from what we've seen so far in the conversions, there really isn't any one call it dominant patient phenotype for conversion. One of the more prominent early factors seems to be, and this is often the case in rare disease launches. It's the frequency of patient visit. So if patient is seeing the clinician every month or every other month versus once every six months, obviously, there are more opportunities to have a discussion on conversion with their clinician.
We also think, and this is a very practical point that patients who live some distance away from their infusion center would be not surprisingly more motivated to switch. So overall, on your question of where do we go from the 40% to get to the 70%, it's going to be the same continued journey as education becomes more prominent across a wider part of the patient and clinician community. Those patient visits will continue, we've made really good progress with the commercial payers. We're now over 75% of the covered lives have a defined policy in place and we don't really hear any resistance on any level from clinicians. It's more about moving through those timelines and the progress that we've made so far.
Ludwig Hantson -- Chief Executive Officer
Next question?
Operator
Thank you. Our next question comes from Steven Seedhouse from Raymond James. Your line is open.
Steven Seedhouse -- Raymond James -- Analyst
Good morning. Thank you. What is the current US insurance mix for patients on SOLIRIS and ULTOMIRIS. And can you at least say, is it appreciably different in gMG versus PNH versus aHUS. And if the new Senate financing Committee drug pricing reform plan were implemented as law as written? What do you assess the impact would be to Alexion? Thank you.
Ludwig Hantson -- Chief Executive Officer
So I'll start with your later, and just a couple of things. As you know, nothing is really concrete, so we'll follow what's going to happen. But overall, we believe our potential exposure is limited. Let me go through a couple of of topics here. First of all, Medicare is a relatively small part of our business, as you know, 60% of our global business this US Medicare is about 20% of our US business. And same true for our Medicare Part D business, which is a very small part of our total global business.
The second point I want to highlight is that our price increases -- or price increases above CPI is not really our business model. We stayed away from that, and that's not how we drive our business. Our direct business is true innovation and an excess and volume.
Then with respect to our pricing strategy, as you know, we have a global sustainable pricing strategy, and Brian already addressed the pricing band that we're trying to respect, but we have a narrow pricing band internationally for SOLIRIS as well as for ULTOMIRIS moving forward. And maybe the last point I want to make is that, rebates is not really our business model, so we have, you could call it price transparency in our business model. So I hope that helps you to frame opposition.
Brian Goff -- Executive Vice President, Chief Commercial Officer
Maybe I'll just add. This is Brian. So I think what we made the points, but it's about 20% Medicare in the US and in the largest portion for us or the commercial payers. There's not really a material difference when you go across indications. But that's why in the case for example of the ULTOMIRIS PNH progress, it's especially important for us that we continue to navigate through the commercial live policy determinations. And each one of those engagements now with multiple launches under way, gives us a chance to give those payers predictability about the outlook ahead. So really commercial is the biggest part of the story.
Ludwig Hantson -- Chief Executive Officer
Okay. We take two more questions.
Operator
Thank you. Our next question comes from Salveen Richter from Goldman Sachs. Your line is open.
Salveen Richter -- Goldman Sachs -- Analyst
Thanks for taking my questions. And just a follow-up on Phil's question. Can you frame for us your expectations into this EU IP oral hearing? And then secondly, when we look at the SOLIRIS launch in NMO, do you expect this to follow a similar cadence to the launch that we've seen for gMG in US and Europe even though I do recognize more touch points here?
Ludwig Hantson -- Chief Executive Officer
Yeah. With respect to the EPO, and Brian will do the second question. EPO there is not much more I can say. So we believe that we have a strong case here. As I said, we have the formulation patent but our overall strategy again is not about SOLIRIS. Our overall strategy is about build to me is making that the standard of care. It will moving quarter-from-quarter, we're moving. So we have note the approval. Germany is launching. We have other countries that will join Germany in the launch later this year. So we believe that we're in a pretty good spot here. With respect to your second question.
Brian Goff -- Executive Vice President, Chief Commercial Officer
Sure. And then with respect to NMOSD, we are excited about the launch opportunity. The fact that this is the first FDA approved treatment option for these patients who were really living in a world of fear given the unknowns in the devastating impacts of these attacks is meaningful, and it's very motivating for us. It is an important growth opportunity. And just to characterize it in gMG, we often cite the -- at the high end of the refractory spectrum. There were about 8,000 patients in the US and that aligns with the Regain pivotal Phase 3 study criteria to dimensionalize it NMOSD in the US is about 4, 000 to 5,000 patients. So a roughly half of the refractory gMG US population. Hopefully that helps sort of frame-up the opportunity. I would say that we have gained a lot of neurology experience in the almost two years that we've been commercializing with gMG as we amortize that into NMOSD as well, but there are some different market dynamics with respect to NMOSD.
One is that, physicians have had nothing that is FDA approved to use, so that with their use of something for example like Rituxan, that's created a sense, we believe a false sense of stability from the tax. And so we're working through that educational aspects of every attack matters and really stable is a false sense of security. And the second one is that we also know that there is potential near-term branded competition on the horizon. We could not be prouder of the very high bar that we've set with the SOLIRIS Prevent study, and none of the competitors on the horizon address complement a core part of the underlying pathophysiology of NMOSD. So those are a couple of dynamics. We don't expect a bolus. We do expect more of a linear uptake as we've seen with the rather neurology launch.
Ludwig Hantson -- Chief Executive Officer
Okay. So we take one more question.
Operator
Thank you. And our final question comes from Hartaj Singh from Oppenheimer. Your line is open.
Justin Kim -- Oppenheimer -- Analyst
Good morning. This is Justin Kim [Phonetic] on for Hartaj. And thanks for the question. I just wanted to see if you could speak a little to how many of the total patients are on SOLIRIS, ULTOMIRIS in the context of the 5,000 patient goal by year-end?
Brian Goff -- Executive Vice President, Chief Commercial Officer
Yes, this is Brian, Justin. So, thanks for the question. We haven't broken down those numbers specifically. But I think we've given enough that you can walk around the numbers and get to the right landing spot. So our ambition is, as you noted to get to 5,000 patients or beyond by year-end. And what's important about that when again to reflect back on prior comments we've made is from the launch of SOLIRIS and PNH back in 2007, up until the middle part of 2017. We had achieved about 2,500 patients on therapy and that's the base indications of PNH and atypical HUS. And in the roughly 2 years, 2.5 years, subsequent to that, we will have double that number. So that gives you a sense of the velocity of change in the meaningfulness of neurology in the business.
And then of course, inside of that, we're actively in the US converting now the PNH patients over to ULTOMIRIS. We're thrilled about the early PDUFA date that we achieved for atypical HUS or excited to upon approval get going on that journey. And then SOLIRIS will continue near term on the neurology path. So hopefully that gives you enough color to dimensionalize the numbers.
Ludwig Hantson -- Chief Executive Officer
Thanks, again, everybody. As I mentioned, I'm really pleased with what we've accomplished so far this year. And I'm really, really proud of the Alexion team. So to all of my colleagues, a big thank you and thanks to everyone for your time today. So, thanks so much.
Operator
[Operator Closing Remarks]
Duration: 56 minutes
Call participants:
Susan Altschuller -- Vice President of Investor Relations
Ludwig Hantson -- Chief Executive Officer
Paul Clancy -- Executive Vice President and Chief Financial Officer
John Orloff -- Executive Vice President, Head of Research and Development
Brian Goff -- Executive Vice President, Chief Commercial Officer
Geoffrey Porges -- SVB Leerink -- Analyst
Matthew Harrison -- Morgan Stanley -- Analyst
Chris Raymond -- Piper Jaffray -- Analyst
Martin Auster -- Credit Suisse -- Analyst
Nate -- Stifel -- Analyst
Phil Nadeau -- Cowen and Company -- Analyst
Kennen MacKay -- RBC Capital Markets -- Analyst
Mohit Bansal -- Citigroup -- Analyst
Steven Seedhouse -- Raymond James -- Analyst
Salveen Richter -- Goldman Sachs -- Analyst
Justin Kim -- Oppenheimer -- Analyst
