Alexion Pharmaceuticals Inc (ALXN) Q1 2019 Earnings Call Transcript

Alexion Pharmaceuticals Inc  (ALXN)
Q1 2019 Earnings Call
April 25, 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 First 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, Investor Relations. Please go ahead, ma'am.

Susan Altschuller -- Vice President, Investor Relations

Thank you, Daniel. Good morning and thank you for joining us on today's call to discuss Alexion's performance for the first quarter 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 thank you, everyone for joining us this morning. I'm very pleased with the strong start to the year. We've delivered on the top and bottom line, and have already made great progress so far on our 2019 key objectives. If you're on Slide 5, I want to highlight some of these achievements. First with ULTOMIRIS, we have an opportunity to redefine the standard of care in PNH and aHUS. Our US launch for PNH is on track to meet our best-in-class goal of 70% or greater conversion by year two. We hope to launch in Germany mid-year and in Japan by the end of this year.

Furthermore, I'm pleased to announce that just this week, we filed the approval of ULTOMIRIS for atypical HUS in US, with a potential launch in early 2020, and are also planning to file in Europe and Japan, this year. Second, we are accelerating on neurology portfolio, building on the best Alexion launch to date. We're seeing continuous strong patient growth with SOLIRIS in gMG. With a PDUFA date of June 28 for SOLIRIS in NMOSD, our team is dedicated and focused on launch preparedness, as we hope to expand into our next rare neurology indication. We also received orphan drug product review for filing in Japan.

In May, we will present additional Phase 3 data at the AAN conference. Given the strength of our clinical data, we believe SOLIRIS could be transformative for patients with this devastating disease. Third, our metabolics portfolio continues to grow with STRENSIQ and KANUMA. We also have an opportunity to bring a transformative product to Wilson disease patients with ALXN1840, and enrollment is on track in our ongoing pivotal study. Fourth, we're executing and expanding our pipeline. We continued to make progress with our internal assets and we have now dosed the first patients in the Phase 3 trial of ULTOMIRIS in gMG, and the Phase 3 trial of ULTOMIRIS administered in a weekly subQ formulation designed to support potential registration in both PNH and atypical HUS.

Furthermore, we continued to build our portfolio with three business development deals, two clinical stage and one pre-clinical stage. Additional business development is a core focus and we have the financial and operational capacity to build our pipeline further. Finally, we delivered very strong financial performance and have updated our guidance to reflect the upward trajectory and growth of the business.

Turning to Slide 6, earlier this year, we laid out our strategy in building four durable growing block bluster pillars as we diversify our portfolio. With our hematology and nephrology, neurology, metabolics and FcRn franchises, we're aspired deliver continued double-digit revenue growth over the coming years. However, we're not sitting still as we plan to further build each of these four pillars as well as potentially expand in other areas of rare disease with a goal of delivering transformative therapies to even more patients.

With that, I will now turn the call over to Paul to discuss our first quarter financial results and updated guidance. Paul?

Paul Clancy -- Executive Vice President, Chief Financial Officer

Thanks, Ludwig. We delivered an excellent quarter to start the year. Starting with Slide 8, we reported total revenues the quarter of $1,140 million, an increase of 23% year-over-year, driven by growth in gMG, the ULTOMIRIS conversion and growth in the core business. Our non-GAAP operating margin was 57% in the first quarter, an expansion of 741 basis points driven by top line leverage in phasing of R&D spend. Non-GAAP earnings per share was $2.39, representing 42% growth year-over-year.

Moving to Slide 9, first quarter net product sales were driven by volume growth of 26%, partially offset by a FX headwind of 1% and a price headwind of 2%. The price headwind was largely result of SOLIRIS price changes in Turkey driven by our formalized reimbursement agreement in the third quarter of 2018.

Turning to Slide 10, SOLIRIS revenue in the first quarter was $962 million with year-over-year volume growth of 23% driven primarily by strength in the US and Japan owing to the growing contribution from gMG. SOLIRIS growth was partially impacted by the conversion to ULTOMIRIS. On Slide 11, you'll see ULTOMIRIS revenue in Q1. The first full quarter since FDA approval was $25 million. Underlying volume growth into PNH and atypical HUS business inclusive of both SOLIRIS and ULTOMIRIS remained strong in the quarter, and we expect it to be in the high single digits for the full year.

Moving to Slide 12, STRENSIQ revenues for the first quarter were $130 million, representing 18% revenue growth and 26% volume growth year-over-year. KANUMA revenues in the first quarter were $24 million, representing 20% revenue growth and 28% volume growth year-over-year. Turning to the P&L on Slide 13, during the quarter, non-GAAP R&D expense was $159 million or 14% of revenues

Non-GAAP SG&A expense was $244 million or 21% of revenues. The non-GAAP effective tax rate in the quarter was approximately 16%. The GAAP tax rate was negative 9% driven by certain one-time tax benefits, primarily related to a tax election associated with the Wilson intellectual property. We reported first quarter non-GAAP earnings per share of $2.39, growing 42% year-over-year. GAAP earnings per share was $2.61 inclusive of the one-time tax benefits. We ended the first quarter with approximately $1.7 billion in cash in marketable securities.

I'll now turn to Slide 14 for the 2019 financial guidance. We're guiding to total revenues between $4,675 million to $4,750 million, an increase from prior guidance. This represents 14% growth year-over-year at the midpoint of the range. For the combination of SOLIRIS and ULTOMIRIS, our revenue guidance is $4,020 million to $4,070 million. This assumes continued momentum in gMG as well as a modest initial contribution from our anticipated US approval in launch in NMOSD in the second half of the year.

Earlier this month, it was announced that SOLIRIS biosimilar was approved in Russia. While Russia represents a small portion of our overall sales, we anticipated this event and it was factored in to our original guidance and included in our updated guidance today. For ULTOMIRIS, we expect steady patient conversion from SOLIRIS to continue for PNH in the US. 2019 revenues benefit from conversion due to the loading dose in the first year.

Turning to metabolics, our revenue guidance is unchanged at $655 million to $680 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 at 2% headwind in 2019 and FX impact net of hedging to represent a $50 million headwind. GAAP operating margin is expected to be 35% to 42% inclusive of restructuring and related expenses as well as upfront payments. Non-GAAP operating margin guidance is expected to be between 54% to 55% unchanged from prior guidance.

Non-GAAP R&D expense is expected to be 16% to 17% of revenues and we expect R&D spend to increase through the course of the year. Non-GAAP SG&A spend is expected to be 20% to 21% of revenues. At the midpoint of this guidance, non-GAAP operating profit is expected to grow approximately 18% year-over-year. We expect the non-GAAP effective tax rate similar to 2018. GAAP earnings per share is expected to be between $6.76 and $7.96. And non-GAAP earnings per share guidance is expected to be between $9.25 and $9.45. The midpoint of this range is approximately 18% growth year-over-year. With the strong first quarter, we're well positioned to deliver on our 2019 financial ambitions.

I'll now turn the call over to John.

John Orloff -- Executive Vice President, Head of Research and Development

Thank you, Paul. We continue to execute on advancing and building out our pipeline. We've made significant progress in each of our four block bluster pillars, which I will highlight today. As seen on the three right-hand columns, we currently have 16 development programs in our pipeline. During the past 12 months we reported positive pivotal data in ULTOMIRIS and PNH and atypical HUS, and with SOLIRIS and NMOSD have progressed ULTOMIRIS into additional Phase 3 trials, and have announced the total of seven business development deals, four clinical stage and three pre-clinical stage. Last month at our Investor Day, we conducted a deep dive on the R&D portfolio and I would encourage you to take a look if you haven't done so already.

On Slide 17, we have outlined our R& D program phasing over the next 18 months. As you can see, we expect the clinical trial activity to ramp up toward the back half of 2019 into 2020 with numerous Phase 3 ULTOMIRIS programs and our ongoing Phase 3 superiority trial for ALXN1840 in Wilson disease. We expect early clinical research and business development will also contribute.

Moving onto Slide 18, you can see our plans to expand patient optionality with our innovative C5 portfolio. Focusing on hematology and nephrology, we have an ambition to raise the standard of care with ULTOMIRIS every week IV in PNH, and have filed for approval in atypical HUS. With our planned higher concentration formulation, which we plan to file in the back half of this year, ULTOMIRIS patients will benefit from both every eight week dosing and reduced infusion time of only 45 minutes. We expect to file our ULTOMIRIS once weekly subcutaneous, utilizing West's patient friendly SmartDose device in late 2020 or early 2021 with potential approval in 2021. Our additional subcutaneous programs including ALXN1720 and our collaboration with Halozyme for ALXN1810 provide opportunity in additional indications. We expect these hematology and nephrology focus complement efforts to extend both the durability and longevity of our complement leadership.

Now, turning to neurology on Slide 19. Building on our base of SOLIRIS, we plan to expand treatment options for gMG patients with ULTOMIRIS as well as our anti-FcRn program ALXN1830. This portfolio approach would allow us to serve patients across the spectrum of disease. I would also note that it is our ambition to launch the first subcutaneous therapy in gMG with our weekly subcutaneous ULTOMIRIS.

In NMOSD, we were granted priority review for SOLIRIS with a US PDUFA date of June 28, and hope to be the first FDA approved therapy. We are committed to innovating for patients and are finalizing our Phase 3 program design for ULTOMIRIS in NMOSD with plans to initiate a pivotal study by year-end. Given the success of SOLIRIS in neuromuscular junction and the CNS, Complement appears to play an important role in neurological diseases. Based on existing scientific literature as well as our own pre-clinical modeling, we see rational to initiate a proof-of-concept study of ULTOMIRIS in ALS in an exploratory clinical trial for the treatment of PPMS in late 2019.

Turning to Slide 20. Our collaboration with Caelum Biosciences is intended to expand and diversify our hematology footprint with the potential to serve patients with AL amyloidosis, a rare disease with a high mortality rate. We saw early proof-of-concept with CAEL-101, which demonstrate a clinical effect on organ function and target engagement in vivo. Pending feedback from regulators of Phase 2/3 study investigating CAEL-101 as add-on to current chemotherapeutic standard of care is planned to begin in early 2020.

Our program in ALXN1840 in Wilson disease depicted on Slide 21, represents an opportunity to expand our existing metabolics business. The Phase 3 trial comparing ALXN1840 was standard of care copper (inaudible) is ongoing and we have enrolled over 70 patients. We believe ALXN1840 has potential to be differentiated with a 10,000 fold higher affinity to copper that results in a unique ability to extract copper directly from the liver, potentially improving liver function and neuropsychiatric symptoms.

Moving to our FcRn pillar on Slide 22. With the recent Affibody deal, we will have the opportunity to address the wide range of IgG-mediated autoimmune diseases with two products. ABY-039 is in a Phase 1 single-ascending dose study. Recall, ABY-039 is a 19 kilodalton bivalent anti-FcRn with a long half life, stemming from its albumin binding domain. We believe there maybe multiple chronic autoimmune diseases well-suited for potentially best-in-class subcutaneous anti-FcRn. With ALXN1830 our initial focus is in warm autoimmune hemolytic anemia and gMG. Due to CMC issUSwith our clinical supply we have made some adjustments to the development plan. While we'll not have supply to complete the Phase I/II warm autoimmune hemolytic study this year we are now planning to move into seamless seamless adaptive Phase II/III studies in warm autoimmune hemolytic anemia and gMG.

We have addressed the CMC issUSand we'll have sufficient clinical supply to initiate these studies by year-end 2019 or early 2020. We will also initiate a Phase I for our 1830 subcutaneous formulation by year-end. I'd like to thank the R&D and business development organizations for their continued efforts to advance our pipeline and portfolio strategy. I'm looking forward to updating you on our progress over the coUS of this year. With that but turn the call over to Brian to discUScommercial highlights for the quarter. Brian?

Brian Goff -- Executive Vice President, Chief Commercial Officer

Thank you John. Starting on Slide 24. While only four months into the launch of ULTOMIRIS for PNH In the US we're very encouraged with the initial progress we've made. As of the beginning of this week 27% of PNH patients were enrolled in one source a leading indicator of conversion and 22% of PNH patients are on treatment with ULTOMIRIS. So we believe we're on the very solid path toward achieving our goal of facilitating a best-in-class SOLIRIS to ULTOMIRIS phn patient conversion of at least 70% within the first two years of launch. The commercial and operational expertise of our team are critical to the success of our launch and we believe ULTOMIRIS sets a new bar for patients. As yoUSe on the left ULTOMIRIS delivers on the key attributes of a best-in-class therapy for PNH. So far patient and physician feedback has been positive. And from a payer standpoint there have been minimal barriers for conversion. And to date over 60% of commercialized now have a defined policy for ULTOMIRIS.

We have a similar ambition to facilitate a rapid best-in-class conversion in Europe and Japan and prelaunch planning is under way with the first potential ex US launch in Germany mid-year. Turning to Slide 25 our Neurology franchise represents a significant growth opportunity both near and long term. This franchise is built upon the success of our launch of SOLIRIS and gMG the best Alexion launch to date. In fact as of this month we're proud to announce that in the US there are over 1000 patients currently being treated with SOLIRIS. And by the end of this year our second full year of launch we anticipate gMG to be the largest US SOLIRIS indication by patient volume. We're excited to build upon our success with gMG as we actively prepare for a potential expansion of SOLIRIS into NMOSD in the US mid-year. There are currently no approved therapies for NMOSD. Patients live in constant fear of the unpredictable and potentially devastating effects of another attack. Therefore relapse prevention remains the primary treatment goal. Given the strength of our data and the significant need we have a sense of urgency to serve these patients.

We are right now expanding our field in medical teams and prelaunch internal training is well under way. We believe we have the right infrastructure in place ahead of our June 28th PDUFA date. Moving to our Metabolic's franchise on Slide 26. We reported first quarter STRENSIQ revenue of $130 million. We expect continued growth coming from STRENSIQ in 2019 as we identify new patients and seek reimbUSment agreements in additional geographies. Kanuma ended the quarter with revenue of $24 million and continUSon the path of steady growth. With the addition of ALXN1840 for Wilson disease we have the potential to further strengthen and grow our Metabolic's portfolio.

We believe 1840 could provide meaningful differentiation superiority over the current standard of care for Wilson disease with approximately 20 000 patients in the US and U5 and the potential to be the first approved therapy in decades. We see significant opportunity for 1840 which if approved will share strong synergies with Kanuma. I want to thank our team for their dedication to bringing hope to patients suffering from rare diseases and would like to reiterate the organizations enthusiasm and commitment as we move through the year. I'll now turn the call back to Ludwig for closing comments. Ludwig?

Ludwig Hantson -- Chief Executive Officer

Thank you Brian. We have already made great progress in the first few months of the year but we're not stopping here. We're well positioned to build on the momentum and deliver on our 2019 objectives. Alexion 2.0 is in its next phase of growth. We continue to execute on our strategy with the goal to make a meaningful impact on patient lives and create long-term shareholder value. As always I would like to thank our global employees for that and dedication to our mission and patients we sort of for their continued trust in us. With that we will now open the call to questions. Operator?

Operator

Good morning and welcome to the Alexion Pharmaceuticals Inc. Conference Call to discUSfirst 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, Investor Relations

Thank you Daniel. Good morning and thank you for joining us on today's call to discUSAlexion's performance for the first quarter 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 discUSd 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 would 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 sUSitute for our GAAP results. Thank you. Ludwig?

Ludwig Hantson -- Chief Executive Officer

Thank yoUSsan and thank you everyone for joining us this morning. I'm very pleased with the strong start to the year. We've delivered on the top and bottom line and have already made great progress so far on our 2019 key objectives. If you're on Slide 5 I want to highlight some of these achievements. First with ULTOMIRIS. We have an opportunity to redefine the standard of care in PNH and HUS. Our US launch for PNH is on track to meet our best-in-class goal of 70% or greater conversion by year 2. We hope to launch in Germany mid-year and in Japan by the end of this year. Furthermore I'm pleased to announce that just this week we filed the approval of ULTOMIRIS for atypical HUS in U. S. with a potential launch in early 2020 and are also planning to file in Europe and Japan this year. Second we are accelerating our neurology portfolio building on the best Alexion launch to date. We're seeing continued strong patient growth with Soliris in gMG. With a PDUFA date of June 28 for Soliris in NMOSD our team is dedicated and focused on preparedness as we hope to expand into our next indication.

We also received orphan drug product review for filing in Japan. In May we will present additional Phase III data at the AAN conference. Given the strength of our clinical data we believe Soliris could be transformative for patients with this devastating disease. Third our metabolic's portfolio continUSto grow with Strensiq and Kanuma. We also have an opportunity to bring a transformative product to Wilson disease patients with 1840 and enrollment is on track in our ongoing pivotal study. Fourth we're executing and expanding our pipeline. We continued to make progress with our internal assets and we have now dosed the first patients in the Phase III trial of Ultomiris and gMG and the Phase III trial of ULTOMIRIS administered in a weekly subQ formulation designed to support potential registration in both PNH and atypical HUS. Furthermore we continued to build our portfolio with three business development deals two clinical stage and one preclinical stage.

Additional business development is a core focus and we have the financial and operational capacity to build our pipeline further. Finally we delivered very strong financial performance and have updated our guidance to reflect the upward trajectory and growth of the business. Turning to Slide 6. Earlier this year we laid out our strategy in building four durable growing block bluster pillars as we diversify our portfolio. With our hematology and nephrology neurology metabolic's and FcRn franchises we're to deliver continued double-digit revenue growth over the coming years. However we're not sitting still as we plan to further build each of these four pillars as well as potentially expand in other areas of rare disease with a goal of delivering transformative therapies to even more patients.With that I'll now turn the call over to Paul to discUSour first quarter financial results and updated guidance. Paul?

Paul Clancy -- Executive Vice President, Chief Financial Officer

Thanks Ludwig. We delivered an excellent quarter to start the year. Starting with Slide 8. We reported total revenUSin the quarter of $1.140 billion an increase of 23% year-over-year driven by growth in gMG the ULTOMIRIS conversion and growth in the core business. Our non-GAAP operating margin was 57% in the first quarter an expansion of 741 basis points driven by top line leverage in phasing of R&D spend. Non-GAAP earnings per share was $2.39 representing 42% growth year-over-year. Moving to Slide 9. First quarter net product sales were driven by volume growth of 26% partially offset by a FX headwind of 1% and a price headwind of 2%. The price headwind was a largely result of Soliris price changes in Turkey driven by our formalized reimbUSment agreement in the third quarter of 2018.

Turning to Slide 10 Soliris revenue in the first quarter was $962 million with year-over-year volume growth of 23% driven primarily by strength in the US and Japan owing to the growing contribution from gMG. Soliris growth was partially impacted by the conversion to ULTOMIRIS. On Slide 11 you'll see ULTOMIRIS revenue in Q1. The first full quarter since FDA approval was $25 million. Underlying volume growth in PNH and atypical HUS business includes the of both Soliris and ULTOMIRIS remained strong in the quarter and we expected to be in the high single digits for the full year. Moving to Slide 12 Strensiq revenUSfor the first quarter were $130 million representing 18% revenue growth and 26% volume growth year-over-year. Kanuma revenUSin the first quarter were $24 million representing 20% revenue growth and 28% volume growth year-over-year. Turning to the P&L on Slide 13. During the quarter non-GAAP R&D expense was $159 million or 14% of revenUS

Non-GAAP SG&A expense was $244 million or 21% of revenUS The non-GAAP effective tax rate in the quarter was approximately 16%. The GAAP tax rate was negative 9% driven by certain onetime tax benefits primarily related to a tax election associated with the Wilson intellectual property. We reported first quarter non-GAAP earnings per share of $2.39 growing 42% year-over-year. GAAP earnings per share was $2.61 inclusive of the onetime tax benefits. We ended the first quarter with approximately $1.7 billion in cash in marketable securities. I'll now turn to Slide 14 for the 2019 financial guidance. We're guiding to total revenUSbetween $4.675 billion to $4.750 billion an increase from prior guidance. This represents 14% growth year-over-year at the midpoint of the range. For the combination of Soliris and ULTOMIRIS our revenue guidance is $4.020 billion to $4.070 billion. This assumes continued momentum in gMG as well as a modest initial contribution from our anticipated US approval in launch in NMOSD in the second half of the year. Earlier this month it was announced that Soliris biosimilars was approved in RUSa.

While RUSa represents a small portion of our overall sales we anticipated this event and it was factored in to our original guidance and included in our updated guidance today. For ULTOMIRIS we expect steady patient conversion from Soliris to continue for PNH in the US 2019 revenUSbenefit from conversion due to the loading dose in the first year. Turning to Metabolic's. Our revenue guidance is unchanged at $655 million to $680 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 at 2% headwind in 2019 and FX impact net of hedging to represent a $50 million headwind. GAAP operating margin is expected to be 35% to 42% inclusive of restructuring and related expenses as well as upfront payments. Non-GAAP operating margin guidance is expected to be between 54% to 55% unchanged from prior guidance.

Non-GAAP R&D expense is expected to be 16% to 17% of revenUSand we expect R&D spend to increase through the coUS of the year. Non-GAAP SG&A spend is expected to be 20% to 21% of revenUS At the midpoint of this guidance non-GAAP operating profit is expected to grow approximately 18% year-over-year. We expect the non-GAAP effective tax rate similar to 2018. GAAP earnings per share is expected to be between $6.76 and $7.96. And non-GAAP earnings per share guidance is expected to be between $9.25 and $9.45. The midpoint of this range is approximately 18% growth year-over-year. With the strong first quarter we're well positioned to deliver on our 2019 financial ambitions. I'll now turn the call over to John.

John Orloff -- Executive Vice President, Head of Research and Development

Thank you Paul. We continue to execute on advancing and building out our pipeline. We've made significant progress in each of our four block bluster pillars which I will highlight today. As seen on the three right-hand columns we currently have 16 development programs in our pipeline. During the past 12 months we reported positive pivotal data in ULTOMIRIS and PNH and atypical HUS and with Soliris and NMOSD have progressed ULTOMIRIS into additional Phase III trials and have announced the total of seven business development deals four clinical stage and three preclinical stage. Last month at our Investor Day we conducted a deep dive on the R&D portfolio and have announced the total of seven business development deals four clinical stage and three preclinical stage. Last month at our Investor Day we conducted a deep dive on the R&D portfolio and have announced the total of seven business development deals four clinical stage and three preclinical stage. Last month at our Investor Day we conducted a deep dive on the R&D portfolio and I would encourage you to take a look if you haven't done so already.

On Slide 17 we have outlined our R& D program phasing over the next 18 months. Complement efforts to extend both the durability and longevity of our complement leadership. Now turning to Neurology on Slide 19. Building on our base of Soliris we plan to expand treatment options for patients with ULTOMIRIS as well as our anti-FcRn program 1830. This portfolio approach would allow us to serve patients across the spectrum of disease. I would also note that it is our ambition to launch the first subcutaneous therapy in gMG with our weekly subcutaneous ULTOMIRIS. In NMOSD we were granted priority review for Soliris with the US PDUFA date of June 28 and hope to be the first fda-approved therapy. We are committed to innovating for patients and are finalizing our Phase III program design for ULTOMIRIS in NMOSD with plans to initiate a pivotal study by year-end. Given the success of Soliris in neuromuscular junction and the CNS complement appears to play an important role in neurological diseases based on existing scientific literature as well as our own preclinical modeling we see rational to initiate a proof-of-concept study of ULTOMIRIS and ALS in an exploratory clinical trial for the treatment of PPMS in late 2019.

Turning to Slide 20. Our collaboration with Caelum Biosciences is intended to expand and diversify our hematology footprint with the potential to serve patients with a rare disease with a high mortality rate the early proof-of-concept study which demonstrate clinical effect on organ function and target engagement in vivo. Pending feedback from regulators of Phase II/III study investigating 101 as add on to current chemotherapeutic standard of care is planned to begin in early 2020. Our program in ALXN 1840 and Wilson disease depicted on Slide 21 represents an opportunity to expand our existing Metabolic's business. The Phase III trial comparing 1840 was standard of care is ongoing and we have enrolled over 70 patients. We believe 1840 has potential to be differentiated with a 10 000 full that results in a to extract copper directly from the liver potentially improving liver function and neuropsychiatric symptoms.

Moving to our FcRn pillar on Slide 22. With the recent deal we would have the opportunity to address the wide range of mediated autoimmune diseases with two products. Is in a Phase I single-ascending dose study. Recall 039 is a 19 anti-FcRn with a long half life stemming from its albumin binding domain. We believe there maybe multiple chronic autoimmune diseases well-suited for potentially best-in-class of subcontinuous anti-fcRn.

With ALXN1830, our initial focus is in warm autoimmune hemolytic anemia and gMG. Due to CMC issues with our clinical supply, we have made some adjustments to the development plan. While we'll not have supply to complete the Phase 1/2 warm autoimmune hemolytic anemia study this year, we are now planning to move into seamless adaptive Phase 2/3 studies in warm autoimmune hemolytic anemia and gMG. We have addressed the CMC issues and we'll have sufficient clinical supply to initiate these studies by year-end 2019 or early 2020. We will also initiate a Phase 1 SAD/MAD study for our ALXN1830 subcutaneous formulation by year-end.

I'd like to thank the R&D and business development organizations for their continued efforts to advance our pipeline and portfolio strategy. I'm looking forward to updating you on our progress over the course of this year.

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

Thank you, John. Starting on Slide 24, while only four months into the launch of ULTOMIRIS for PNH In the US, we're very encouraged with the initial progress we've made. As of the beginning of this week, 27% of PNH patients were enrolled in one source, a leading indicator of conversion and 22% of PNH patients are on treatment with ULTOMIRIS. So we believe we're on a very solid path toward achieving our goal of facilitating a best-in-class SOLIRIS to ULTOMIRIS PNH patient conversion of at least 70% within the first two years of launch.

The commercial and operational expertise of our team are critical to the success of our launch and we believe ULTOMIRIS sets a new bar for patients. As you see on the left, ULTOMIRIS delivers on the key attributes of a best-in-class therapy for PNH. So far patient and physician feedback has been positive. And from a payer standpoint, there have been minimal barriers for conversion and to-date over 60% of commercialized now have a defined policy for ULTOMIRIS. We have a similar ambition to facilitate a rapid best-in-class conversion in Europe and Japan, and pre-launch planning is under way with a first potential ex-US launch in Germany mid-year.

Turning to Slide 25, our neurology franchise represents a significant growth opportunity both near and long term. This franchise is built upon the success of our launch of SOLIRIS in gMG, the best Alexion launch to-date. In fact, as of this month we're proud to announce that in the US, there are over 1,000 patients currently being treated with SOLIRIS. And by the end of this year, our second full year of launch, we anticipate gMG to be the largest US SOLIRIS indication by patient volume.

We're excited to build upon our success with gMG as we actively prepare for a potential expansion of SOLIRIS into NMOSD in the US mid-year. There are currently no approved therapies for NMOSD. Patients live in constant fear of the unpredictable and potentially devastating effects of another attack. Therefore relapse prevention remains the primary treatment goal. Given the strength of our data and the significant need, we have a sense of urgency to serve these patients. We are right now expanding our field in medical teams and pre-launch internal training is well under way. We believe we have the right infrastructure in place ahead of our June 28, PDUFA date.

Moving to our metabolics franchise on Slide 26, we reported first quarter STRENSIQ revenue of $130 million. We expect continued growth coming from STRENSIQ in 2019 as we identify new patients and seek reimbursement agreements in additional geographies. KANUMA ended the quarter with revenue of $24 million and continues on a path of steady growth.

With the addition of ALXN1840 for Wilson disease, we have the potential to further strengthen and grow our metabolics portfolio. We believe ALXN1840 could provide meaningful differentiation and superiority over the current standard of care for Wilson disease with approximately 20,000 patients in the US and EU5, and the potential to be the first approved therapy in decades. We see significant opportunity for ALXN1840, which if approved will share strong call point synergies with KANUMA.

I want to thank our team for their dedication to bringing hope to patients suffering from rare diseases. And we'd like to reiterate the organization's enthusiasm and commitment as we move through the year.

I'll now turn the call back to Ludwig for closing comments. Ludwig?

Ludwig Hantson -- Chief Executive Officer

Thank you, Brian. We have already made great progress in the first few months of the year, but we're not stopping here. We're well positioned to build on our momentum and deliver on our 2019 objectives. Alexion 2.0 is in its next phase of growth. We continue to execute on our strategy with the goal to make a meaningful impact on patient lives and create long-term shareholder value. As always, I would like to thank our global employees for that and dedication to our mission and patients we serve for their continued trust in us.

With that, we will now open the call to questions. Operator?

Questions and Answers:

Operator

We will now turn to the question-and-answer portion of our call. (Operator Instructions) Our first question comes from Geoff Meacham with Barclays. Your line is now open.

Geoff Meacham -- Barclays -- Analyst

Good morning, guys. Thanks for the question. I just had a commercial one and then a real quick one for John. So on ULTOMIRIS in the US Brian, what's been the gating factor for access? It seems straightforward to do so to switch and fairly quickly, but how would you expect that to differ outside the US? I would obviously think pricing will be a big driver outside the US for example. And then for John, you guys have obviously pretty broad roll-out for ULTOMIRIS in terms of new studies and it's having an impact on perhaps the competition in enrolling patients. I want to maybe ask you that more broadly, are you finding it tougher as you expand the ULTOMIRIS breadth of development to find patients for some of -- for going back to ALS and then also looking forward to gMG or to NMO? Thank you.

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. Hey, Jeff, it's Brian. I'll start with your first question around the access. And for ULTOMIRIS as I mentioned, we're pleased with the progress. As I noted, we're now over 60% of commercial covered lives with the determined policy and that's right on track with the pace that we expected. We saw the same general progress with gMG with the launch of SOLIRIS for gMG. And really what in the US what gates it is, you noted price, of course that's a key factor and the value story, but there's also a lot of these payors have scheduled timing for their reviews to make their policy determinations. So we're working through that. And then a little bit deeper in the institutional setting, there also are formulary decisions that likewise need to be made. And that's what covers the academic access for the most part.

Ex-US, I think, you have similar dynamics in a way pricing value becomes a key part of the discussion of course. And then there will be single-payer policy determinations, which in a way could accelerate that pathway and then you get more locally the same thing at the institutional level. I think just keeping in mind what happens for 2019, beyond the US it's really a story about Germany at the mid-year point. And in Germany, you essentially have free pricing in the first year of pre-AMNOG, and then later in the year we would look to reimbursement determination for Japan, our second key launch. And then, John?

John Orloff -- Executive Vice President, Head of Research and Development

Hey, Geoff, this is John. So with regard to trial enrollment, as you know, we've completed a atypical HUS study and we filed now in the US and we're on the verge of filing also in Europe and Japan. gMG is probably the highest competitive intensity and yet we have the advantage of knowing those investigators and those sites worldwide. And we are in the process now of enrolling that study, so we're pretty confident we'll be able to enroll that as quickly as we possibly can.

For NMO, that's going to start later this year; lower competitive intensity, but again we know the players in the field. And with regard to the high reward high risk indications ALS and PPMS that's totally new territory, so we're confident we can execute on the clinical development plan.

Geoff Meacham -- Barclays -- Analyst

Okay. Thanks, guys.

Ludwig Hantson -- Chief Executive Officer

Thank you. Next question?

Operator

Thank you. Our next question comes from Kennen MacKay with RBC Capital Markets. Your line is now open.

Kennen MacKay -- RBC Capital Markets -- Analyst

Hi. Thanks very much for taking the question. I was wondering maybe if you could help us understand a little bit what's some of the manufacturing issues were before getting the Phase 3 started for the FcRn. Is this something that was in-house or is this an issue with the CMOs or intellectual transfer? And then separately, I was just wondering about the Russian biosimilars. I was wondering if you could help us understand the clinical trial that got that biosimilar there from Generium, and whether that was something that could be supportive of an approval for that agents in the rest of mainland Europe given they do have some partnerships with European biosimilars such as (inaudible)

Ludwig Hantson -- Chief Executive Officer

(multiple speakers) Yes. Go ahead.

John Orloff -- Executive Vice President, Head of Research and Development

Yes. For the ALXN1830 program as you know, we acquired Syntimmune, and process the manufacturing that supported those clinical trials. And as you also know, we had three Phase 1b/2a studies ongoing in PV warm autoimmune hemolytic anemia in a healthy volunteer multiple ascending dose study, and those were progressing well. But we discovered an impurity in their drug product that we've investigated. We've identified the cause and the source and we've corrected those manufacturing issues with new drug substance runs that will allow for clinical supply by the end of this year when we can sort of reinitiate the clinical program. So we're doing everything we can to preserve the original time lines. But there will be a delay in starting the pivotal programs as we articulated previously for WAIHA and for gMG.

Brian Goff -- Executive Vice President, Chief Commercial Officer

It's Brian. So the Russian biosimilar still no surprise for us and also no surprise moving forward.

Ludwig Hantson -- Chief Executive Officer

Yes. And maybe I'll start and Paul if you want to add anything. As Paul, had noted in his commentary that we have worked this into our guidance. It's already included, we believe it's generally limited to Russia, CIS. In terms of the exact specifics of the clinical program. We don't know we haven't seen it. But for EU and boundaries outside of Russia, CIS, there are different regulated requirements like conducting clinical trials and having sites in Europe. And so generally we believe that this is isolated to Russia, CIS. Anything else Paul?

Paul Clancy -- Executive Vice President, Chief Financial Officer

Yes. And Mack, I just -- I'd also Mack just point you to that we have protection in Europe right now as well as ODD protection. And just to reinforce what Brian said, the regulatory hurdles are fundamentally different.

Ludwig Hantson -- Chief Executive Officer

Yes, which we didn't have in Russia. So...

Paul Clancy -- Executive Vice President, Chief Financial Officer

Exactly.

Ludwig Hantson -- Chief Executive Officer

...we -- our IP was -- we didn't have an IP in Russia. So I would say, it is as expected. I think most of us or all of us have experience with dealing with Russian market. We think it's going to be isolated to Russia plus the countries that Brian highlighted. So we don't see anything happening in Europe with Generium. Next question?

Operator

Thank you. Our next question comes from Geoffrey Porges with SVB Leerink. Your line is now open.

Geoffrey Porges -- SVB Leerink -- Analyst

Good morning and thanks for taking my question. One perhaps for Brian and then one for Paul. Brian, just quickly on the NMOSD, as you prepare for the launch, can you give us a sense of what the unmet need in the patient population is, particularly what the population of recent relapses or more active in refractory diseases that you think is possible to start on treatment relatively quickly? And then Paul, looking at all of the clinical trials you have getting under way in the beginning of next year, and also the investments you're making in the neuro and muscle franchises, could you give us a sense of where you think your operating margin could go, is it feasible for us to be modeling stable operating margins next year, or is it (inaudible) come under pressure?

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. Hi, Jeff. Good morning. It's Brian. I'll start with your first question on NMOSD. And of course I'll begin by saying that we're really pleased to have the opportunity. Every time we reflect on the data and the strength of what we saw in terms of the patients who are relapsed free, which we really think will be the key aspect of focus on NMOSD, the fact that we had nearly 98% at 48 weeks is very significant. So that's kind of the starting point for where our focus will be is it's all about the relapse.

That said to your question about how do we think about the opportunity. We've talked that in the US it's 4,000 to 5,000 patients that are -- that on line with the PREVENT pivotal Phase 3 clinical program. It's a subset of that that we would expect in the early days would be in the so-called actively relapsing segment. And that will be our very initial area of focus once we do have approval from the FDA. There are also important differences between NMOSD and the launch that we had in gMG, maybe just to name a couple, one is that there are no approved therapies available, but Rituxan is commonly used as off-label treatment.

And because of the severity and the significance of these attacks or these relapses in NMOSD, we do anticipate that there'll be some patient reluctance to switch therapies, and we're going to have to work through the educational aspects at both the patient level as well as the provider level. Secondly, we're also aware that there is potential near-term competition on the horizon. Although what will be unique of course about SOLIRIS is the complement mechanism of action, which we believe is fundamental to addressing this disease. And then the third point is what I already mentioned that the population is smaller than gMG, but still for us another example of potentially moving from ultra-rare to rare. So we're excited to have the chance to expand our neurology footprint focus.

Paul Clancy -- Executive Vice President, Chief Financial Officer

Jeff, this is Paul. Thanks for the question. I'm going to try to answer it at a little bit more reconceptual level because obviously we're not kind of getting into 2020 numbers at this point in time. But I think, you're absolutely right from a thesis perspective that what we would love to see and it's part and parcel to the strategy of the Company is growing R&D driven by a growing and expanding pipeline. And as we progress through the year, it's exactly as you kind of pointed out is probably three things that really drives that growing R&D, which is ULTOMIRIS broadening into additional indications and additional studies, subQ, gMG, NMOSD, ALS, PPMS. So it's a really big strategy around ULTOMIRIS for the long term.

Progression of kind of what I call the newly -- the newer assets into the pipeline through business development activity over the last 12 to 18 months including Wilson, both the FcRn assets moving forward Caelum, and we have dollars earmarked for additional pipeline coming from business development. So we -- that's not -- we don't know what that is yet, but we do. And that we flip over into 2020. I think, that's very, very healthy and it's actually consistent with the strategy, and it will result in a growing -- hopefully a growing R&D budget.

I think we see SG&A leverage on the flipside. And I wouldn't point to kind of SG&A dollars meaningfully coming down or anything like that. It's just more SG&A leverage on top of hopefully double-digit kind of revenue growth. And the combination of those things I think, can expand margins modestly in continued progress margins. We will do what's right for growing the business over a long period of time. But with that mentality kind of -- so I'll keep it a conceptual level for the time being. Hopefully that helps.

Geoff Meacham -- Barclays -- Analyst

Okay.

Operator

Thank you. And our next question comes from Paul Matteis with Stifel. Your line is now open.

Paul Matteis -- Stifel -- Analyst

Great. Thanks very much for taking the questions. A couple quick questions on MG and ULTOMIRIS. I was wondering if you could offer any color on the characteristics of the early adopters of the ULTOMIRIS population, whether or not they're younger or whether or not they have more or less comorbidities and the insurance mix? And then separately gMG, it looks like the patients on therapy are remarkably stable over the past couple of quarters, are the underlying drivers of that stable being new prescriptions and also discontinuations? Thanks so much.

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. Hey, Paul, it's Brian. So I'll start. I'll go in the order that you just mentioned with ULTOMIRIS. I probably won't be able to give you as much detailed color as you're looking for, for the patient types. I think what you're seeing in the uptick we've had so far, which has been steady. I mean, we've been consistently reporting out the progress we've made is a function of a few different attributes. One is patients who have awareness of the availability of ULTOMIRIS, of course and the motivation to benefit from that shift going from living life in two-week cycles to every two months, which is significant.

That has to be matched up with the doctors themselves being aware of ULTOMIRIS. And it's interesting with PNH. It's an ultra-rare disease, so in a lot of the cases you have doctors who -- it might be the first time that they've actually been exposed to a PNH patient in the case of new patients. With the switchers, the awareness is pretty high with doctors who have PNH patients and then it's gated (ph) by their access, that's why we're pleased with the progress that we're making with commercial payers as well as I noted at the institutional level. And I just think as we progress, you'll see continued different cohorts of patients moving on therapy once they pass through that access and their awareness of the product. So far so good and very consistent uptake as you've seen in the numbers.

In the case of gMG, I would agree with your commentary that it is remarkably stable. It's what we had predicted. That's the dynamic that we see (technical difficulty) in rare diseases. We're looking at in the case of gMG a larger population of course than in PNH. And we continue to make progress on both breadth of prescribing new prescriber, new neurologists who are experiencing SOLIRIS and understanding the complement mechanism in gMG for the first time. And we're also beginning to make some inroads in terms of depth of prescribing -- repeat prescribing that is. And that with again the background of strong payer support and a product profile with SOLIRIS that plays out very nicely has just continued us on that journey of continued uptake.

Susan Altschuller -- Vice President, Investor Relations

Great. Next question?

Operator

Thank you. Our next question comes from Chris Raymond with Piper Jeffrey. Your line is now open.

Chris Raymond -- Piper Jeffrey -- Analyst

Yes. Thanks. Just on the ULTOMIRIS, PNH conversion, so your chart on Slide 24 I think shows a really nice linear conversion trend. I guess just eyeballing it, it looks like if that trend continues linearly, you could be at that 70% number quite a lot earlier than your guidance for that two-year point. So maybe you could you just talk, is there something that you see down the road that indicates the flattening of that conversion curve, any sort of color there would be great.

And then maybe for John. On the Affibody compound, I know guys you have guided to disclosing initial indications, I think in pursuit by the end of the year. But can you talk about what's gating that disclosure? Is it a matter of deciding between multiple options and that the healthy volunteer data will be critical to picking that -- those indications, or are you more focused on keeping competitors in the dark as long as possible?

Ludwig Hantson -- Chief Executive Officer

Good questions, Chris.

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. Hey, Chris, it's Brian. So I'll start. On ULTOMIRIS, we are really pleased with the progress that we've made it. We put out what we believe to be a bold but appropriate ambition to have facilitated patient conversion in PNH of 70% or more by the two-year mark from launch. And we're -- as I noted, we're right on track with that. We're -- I would hedge to make any predictions about where we are going to be at the end of the year, other than to say we stick with the same ambition. Just as a reminder, we're only a little less than four months into the launch in the US. And it goes in a way back to the previous questions that Paul had asked about what types of patients are we seeing in the early adoption, too difficult to know at this stage. And that's what makes it a little bit challenging to know what the exact uptake will be. But I've been in rare diseases long enough to say that we're not seeing a bolus. We see consistent progress and that's essentially what I would expect going forward. And we're really proud of what the team has executed so far.

Ludwig Hantson -- Chief Executive Officer

I would add that the first six months define the success of the launch and we're really pleased with what we've seen so far. But I don't think anything in our business is linear forever, so we're going to stick to a 70% conversion ambition that the team has done a great job. But it comes back to the value of this molecule and what it means for patients. And then Affibody?

John Orloff -- Executive Vice President, Head of Research and Development

Yes. And with regard to ABY-039, I think we're considering the same menu of indications that we're targeting for ALXN1830 in terms of autoimmune rare diseases. Its differentiating features would include a longer half-life as well as a smaller volume for subcutaneous administration. So we're looking at diseases where that is a key attribute for the target patient population. And I would add also for ALXN1830, we have very strong data supporting that product profile. And while we had prematurely pause the Phase 2 program as we reported last year in pemphigus vulgaris, we had at -- what I would consider a subtherapeutic dose at 10 milligrams per kilogram IV weekly over five weeks, a 57% reduction in IgG lowering, and a reduction in PDI (ph) scores.

And with warm autoimmune hemolytic anemia study, which we've also had to pause after the first cohort, again dosing with what we consider subtherapeutic dose at 10 milligrams per kilogram over five weeks we had 55% reduction in IgG lowering with a clinical response seen in some patients. And then in healthy volunteer MAD study, we're able to get up to 20 milligrams per kilogram IV times three weeks with 64% IgG lowering before we had to pause. So we're very positive on this program. We want to take forward and get into Phase 2/3 seamless adaptive pivotal studies for hemolytic anemia in gMG early next year.

Chris Raymond -- Piper Jeffrey -- Analyst

Thank you.

Ludwig Hantson -- Chief Executive Officer

Grateful. Take the next question.

Operator

Thank you. Our next question comes from Anupam Rama with JPMorgan. Your line is now open.

Unidentified Participant -- -- Analyst

Hi. This is (inaudible) Anupam this morning. Thank you for taking our questions and for the updates here. Maybe two from us. Competitively how are are you thinking about hemoglobin changes with ULTOMIRIS, SOLIRIS and PNH, and what specifically are you hearing in the marketplace on this endpoint? And then second one if I could on SOLIRIS gMG. You highlighted a 1,000 patients on SOLIRIS in the US in mid April, has there been sources of inefficiency on getting patients on therapy with time? I'm just curious what percent of those patients are currently enrolled in SOLIRIS and how might these trends look outside of the US. Thanks so much, guys.

Ludwig Hantson -- Chief Executive Officer

John?

John Orloff -- Executive Vice President, Head of Research and Development

Yes So we previously reported the results of the 301 and 302 study, which had hemoglobin stabilization in three quarters to 85% of patients transfusion independence, and 74% in the 301 trial, and 88% in the 302 trial. So we have a really -- a positive impact in hemoglobin, which did go up in the 301 study. I think, you maybe referencing some of the competition that's looked at out patients starting out with a low hemoglobin who have had increases. And I think that those are carefully selected patients that had no bone marrow failure, high reticulocyte count and anemia to begin with to demonstrate that response, which is a subset of patients as we said previously with extravascular hemolysis representing less than 10% of the overall population of patients with PNH that have -- that as a potential issue to address. But it doesn't represent the broad population of PNH patients, which has driven by intravascular hemolysis, which is well addressed in the past with the SOLIRIS and now with the ULTOMIRIS are raising the bar.

Brian Goff -- Executive Vice President, Chief Commercial Officer

And then I'll pick up with the gMG question, I'll try to get them all, so just let me know if I missed one. But starting with your question on the -- more than a 1,000 patients as of the midpoint in April that we're very proud of the continued progress. I'll try a little bit of the literation here on you asked about efficiency, I think, it comes down to number one expertise. We now have quite a significant expertise, particularly in gMG and we expect fingers crossed to be moving into the NMOSD space once we have approval there as well. So expertise comes into play.

The experience itself, not just our own experience, but as I noted with a growing prescriber base of neurologists as we build out that breadth and depth. And then the third is, I had noted in my comments that we've expanded and we did that because we see a broad population for gMG that could benefit from SOLIRIS and we want to continue on that journey, and as well that's a look ahead to NMOSD in -- potentially even longer term other areas in neurology that we'd like to move into.

Outside the US, which was the other part of your question, we have gMG in both Germany and Japan. I think both of those markets are different from US and in fact different from each other. Japan is making good progress, probably more similar to US types of prescribing dynamics. Germany has been slower going, which we've talked about on prior calls and tends to be more gated by dependency on guidelines, which just inherently take longer to form an update. So that's where we are. But again in the US, which is the bulk of our business, in gMG we're particularly proud. And one last one that you had asked about is OneSource. The overwhelming majority of those patients are enrolled in the OneSource program, which is helpful for patients to get on therapy as well as to navigate through the system.

Ludwig Hantson -- Chief Executive Officer

As we have said, SOLIRIS MG is never going to be a big business in Europe. But we're really pleased with two biggest countries, US and Japan. Next question, please?

Operator

Thank you. Our next question comes from Phil Nadeau with Cowen and Company. Your line is now open.

Phil Nadeau -- Cowen and Company -- Analyst

Good morning. Thanks for taking my question. Just a follow-up question on competition from the last one. First on 301 and 302 studies, have you ever disclosed what the hemoglobin levels were for patients in those trials? And secondly, what is your understanding of the status of the competition that's out there, so where the biosimilars in enrolling patients, the other branded players like Chugai, Regeneron, are they still planning to move forward in PNH (inaudible) or have their plans changed?

John Orloff -- Executive Vice President, Head of Research and Development

So with regard to the 301, 302 studies, the baseline hemoglobin in 301 was 9.5, and we had about 70% that stabilized and there was maybe about a gram increase in response to therapy during the study. The 302 study had baseline hemoglobin of 11. And I'd point out that based on our feedback from many KOLs in the field, typically the trigger for transfusion is about 8 grams per deciliter, even though a value of 9 or 10 or 11 is below the lower limit of normal. Normally patients don't have symptoms related to that level of anemia.

Contrast that to some of the other trials that have been conducted where based on hemoglobins have been as low as 8 like in the hepatic trial in a monotherapy in naive PNH patient population, which I think represents a careful selection of patients with anemia in absence of bone marrow failure. So we are enrolling the broad set of patients in our program. This was the largest PNH program ever conducted with nearly 450 patients that represents PNH population that we treat today.

Ludwig Hantson -- Chief Executive Officer

With respect to the status of competition for biosimilars, we are not aware of any active enrollment in the Phase 3 program for the Amgen Phase 3 study. So our best estimate is that this will take at least three years from start. We think it's an 18-month study, but that's a question for Amgen regulatory time lines and so on. So I think it's at least three years away I would say to the best of our knowledge. And then on Chugai and Regeneron, I think we all know the epitope issue what it means now for PNH and HUS because that's a question for Chugai and Regeneron, but we're not aware of any active Phase 3 program.

Susan Altschuller -- Vice President, Investor Relations

Next question?

Operator

Thank you. Our next question comes from Josh Josh Schimmer with Evercore ISI. Your line is now open.

Josh Schimmer -- Evercore ISI -- Analyst

Thanks for taking the questions. First, can you provide a little bit more granularity on the timing of the launch of the gMG and NMO indications beyond US, Germany and Japan for key incremental markets? And then there is clearly a pent up unmet need for the gMG population, any thoughts as to how much longer it will take to work through those patients to get them on therapy, and what are the gating steps for them considering the severity of that disease? Thank you.

Ludwig Hantson -- Chief Executive Officer

John, you want to do?

John Orloff -- Executive Vice President, Head of Research and Development

Yes. I would just say for NMO, we have a PDUFA date in the US for June 28, so we do anticipate approvals both in Japan and in Europe in the latter half of 2019. Those filings are under review currently and then...

Ludwig Hantson -- Chief Executive Officer

And Japan is -- could be a strong NMO market. Brian?

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. I'll just say, Japan has higher prevalence actually than most other countries in the world, and so it's an interesting opportunity for us in the case of NMOSD to match up with the launch in the US as an opportunity. So those are the near-term launch opportunities, which would be in the second half of this year with approval. And then I think the other question you had was around...

John Orloff -- Executive Vice President, Head of Research and Development

gMG.

Brian Goff -- Executive Vice President, Chief Commercial Officer

...gMG, and I just wanted to make sure I understood, which you're looking for.

Josh Schimmer -- Evercore ISI -- Analyst

Sorry. The first question was markets beyond US, Germany and Japan, and then for gMG, how much longer do you think it will take to work through the -- this kind of pent up unmet need of patients?

Brian Goff -- Executive Vice President, Chief Commercial Officer

Okay. Well, so for gMG, the -- I mean it is a big opportunity. We've talked many times about the population that aligns with the regain trial of -- in the US 3,000 to 8,000 patients, but the overall population is 60,000 to 80,000 patients. So what's the finish line of that opportunity, I don't know. We're very pleased with the continued progress we've had. The fact that we crossed over 1,000 patients in mid-April, not just because it's a round number, but it just signifies that at this point in the continued launch, we are continuing to identify patients and to appropriately educate physicians around complement as a novel mechanism of action that they've not had experienced with before.

And I think what you have is a dynamic where the physicians are now seeing themselves personally how the product plays out with their patients and also hearing from others how their peers are experiencing SOLIRIS. And so I just -- I'd go back to the comment that I think we'll stay on a solid trajectory of continued growth and penetration into that market. And not only does that help the patients with gMG, it also continues to build experience for us in neurology and creates a pathway to move hopefully with approval in NMOSD from a peripheral neurological condition to one that act centrally as well.

Ludwig Hantson -- Chief Executive Officer

Operator, we'll take three more questions.

Operator

Thank you. Our next question comes from Matthew Harrison with Morgan Stanley. Your line is now open.

Matthew Harrison -- Morgan Stanley -- Analyst

Hi. Good morning. Thanks for taking the question. And just a clarification for John, and then a second question. John, on the FcRn study that you've had to stop, would we end up seeing any of that data or just what you described earlier is that all we're going to hear about that before we see Phase 3 data? And then the second, I'm just wondering if you guys can maybe comment on the current pricing environment? And there's been more talk of maybe IPI (ph) coming back as a -- as something that HSS (ph) will push forward, I wonder if you have a view on that? Thanks.

John Orloff -- Executive Vice President, Head of Research and Development

So with regard to ALXN1830, as you know, we have shared the PV data. It was last year. And right now because we had prematurely paused the hemolytic anemia of Phase 2 program after only dosing the first cohort, we will not be sharing anything further this year beyond what I just said in terms of IgG lowering and the fact that we had a clinical response in some of those patients. And look forward to exploring higher doses in the front end of a pivotal program that would include a dose ranging component to that study, so that we can properly identify dose that we would take into the pivotal stage of the trial.

Ludwig Hantson -- Chief Executive Officer

Yes. With respect to pricing and we've discussed this several occasions, Matthew. So we believe in a global sustainable pricing strategy, it is essential that we continue to focus on innovation in ultra-rare and rare diseases. As you know, 7,000 rare diseases that we have a long long way to go in trying to find solutions for those patients. You also know that our growth is driven by volume, innovation being central. You know what our ULTOMIRIS pricing strategy is in the US where we have a 10% discount for PNH. And once we get approval for aHUS, we're talking about 30% discount and we'll start the aHUS conversion at that point.

We are focusing on a tight pricing band globally and we've done that in the past and our ambition is to continue to do so. Having said that, we also are going beyond patch, which means that we are proactively assessing and also implementing innovative ways of working with payers to support patient access.There is also dialogue in addition to the international pricing reference dialogue -- potential dialogue on a single payer -- a potential single payer system in the US. We have successfully operated in countries with single payer system. So we believe that the focus that we've had as an organization on this important topic is the right one. And we believe that we're in a sustainable pricing situation. I hope that helps.

We'll take two more questions. Susan, I'm looking at you. Do we have time for two more questions?

Operator

Thank you. Our next question comes from Robyn Karnauskas with Citi. Your line is now open.

Robyn Karnauskas -- Citi -- Analyst

Hi, guys, thanks for taking the question. So just some thought questions on FcRn. So for the Affibody, do you think that there could be any difference in the profile as far as headache given the trial administration and how it's acting on the body, or if there's any risk of lowering albumin too much that'll be a concern? And second question would be do you know if FcRn has an impact on lowering complement, not just lowering IgG do like IV -- IgG does, so does it do other things besides lowering IgG? Thanks.

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. So with regard to ABY-039, we do know the binding epitope on albumin for that molecule, and we know that it does not share any overlap with the binding site for albumin on FcRn, so therefore there is no reduction in albumin with ABY-039. As we also said for ALXN1830 in contrast to some of the anti-FcRn competition where there is a overlap with the IgG bonding sites as well the albumin binding sites on the FcRn, so there is no effect on albumin. I can say that based on the fact that we've initiated the SAD/MAD studies already that are ongoing.

And then with regard to additional effects beyond IgG lowering, we don't have evidence that there is per se reduction in complement, but of course lowering IgG will have a downstream effect of less comp -- activation of complement. The fact that we cannot lower it to zero and we don't want to lower it to zero, there will still be some underlying complement activation in diseases where that plays a role. We also know that these molecules do interact with other receptors Fc gamma receptors and some of them are proinflammatory or anti-inflammatory, and that could be potentially differentiating across the class.

Susan Altschuller -- Vice President, Investor Relations

Question?

Ludwig Hantson -- Chief Executive Officer

I think Susan we can take two more. Yes.

Operator

Thank you. Our next question comes from Steven Seedhouse with Raymond James. Your line is now.

Steven Seedhouse -- Raymond James -- Analyst

Thank you. Good morning. Can you perhaps quantify what percent of patients on SOLIRIS and PNH have actually visited their physician so far since ULTOMIRIS approval with the coverage policy in place, and sort of made the explicit decision to either switch to SOLIRIS or switch to ULTOMIRIS or stay on SOLIRIS? And is it that number closer to 70% or closer or a much higher? Just trying to understand after you hit 70% conversion, what the ceiling might be on total conversion.

And then secondly, as you think about new indications for ULTOMIRIS like ALS and PPMS, it looks like those trials will utilize IV ULTOMIRIS, and if that's the case what I guess drives the decision to start development of new indications with IV formulations opposed to subQ and is it because the IV formulation might be the best proof-of-concept test or optimal exposure? Thank you.

Brian Goff -- Executive Vice President, Chief Commercial Officer

Yes. Stephen, it's Brian. Good morning. So I wish I could answer your question, but we're talking about an ultra-rare population with a lot of variability actually in the cadence with which these patients visit their clinicians, that's dictated based on their own condition and the agreement that they have with their clinician. So it's variable. You have some who see their clinicians tends to be once a quarter, some who are every six months or so and some less frequently, again depending on what intensity they agree on with their physician. So I can't give you the facts as to exactly where we are.

I think what we're encouraged is that we are making progress as I noted with the payers and so that just removes one more sort of logistical barrier for when they do make that visit. Secondly, the awareness continues to grow, and particularly among those who have active PNH patients. And then there is also the scenario of new patients who are not switches per se, but have now been diagnosed with PNH may see a physician who has not had any experience with SOLIRIS or ULTOMIRIS. And there there is a dynamic where they may actually prescribe SOLIRIS first and then what we do is deploy our teams to give appropriate education around ULTOMIRIS as a treatment option, and that's also a part of the switching component. But it's still early days and I just can't give you too much more detail than that at this stage.

John Orloff -- Executive Vice President, Head of Research and Development

And with regard to the new indications, as you know, we are studying the subQ formulation within on-body delivery device in PNH that will get us approval hopefully pending successful competition of study in PNH as well as atypical HUS. I think, the decision to go forward with IV is more related to timing and repetity (ph) as well as the plan to bridge to the 303 subQ data, which would appply not only to PPMS and ALS, but also to MG and NMO.

Susan Altschuller -- Vice President, Investor Relations

Final question.

Operator

Thank you. Our final question comes from Ying Huang with Bank of America Merrill Lynch. Your line is now open.

Ying Huang -- Bank of America Merrill Lynch. -- Analyst

Hi. Good morning. Thanks for taking my questions. My first one is regarding the guidance you provided today with the update. So if I add up this quarter's revenue for both SOLIRIS and ULTOMIRIS, it gets to about $986.6 million. If I just flat lines the next three quarters, I really don't see a lot of room for growth to the midpoint of the guidance. I was wondering if you can elaborate the factors when you contemplated on your guidance besides the one time in $9 million tender? And then secondly maybe for John. You announced today that ALXN1810 you've completed dosing in Phase 1, so I was wondering when we might learn about the data from the Phase 1 compared to let's say the PK/PD data? And also can you remind us the volume of injection for the subQ? Thanks.

Paul Clancy -- Executive Vice President, Chief Financial Officer

Ying, this is -- I'll start. And it's Paul. I just point you to what we kind of have said in the past is what was today. FX as we move through the year would be a little bit of a headwind, that's kind of a lot of the wraparound impact on Brazil and Turkey. We think there's a bit of a price headwind that we pointed out. Now, about one-third of that attributable toward SOLIRIS. Included in our guidance as it was included at the beginning of the year is competitor trial estimates and we'll see how that plays.

And then as we had pointed out at the beginning of the year, in some of the international markets, we're making a direct to distributor change that will be plus or minus PVT or profit neutral, but will be a little bit of headwind on the top line. That's the stuff I think I'd just point to. And then clearly on the other side, the underlying growth we think on a unit basis continues to be high-single digit on PNH and aHUS, strong growth on MG, contribution from NMOSD in the back end of the year.

John Orloff -- Executive Vice President, Head of Research and Development

And with regard to ALXN1810, we've completed dosing in a healthy volunteer study. And the results of that indicate that we were able to increase bio-availability from the previous studies we've done with ALXN1210 subQ, which was about 60% bio-availability, and now we can increase that with the addition of PH20 and the ALXN1810 formulation to 73% at a minimum. This allows us to be able to dose at least every two weeks with a single on body delivery system. And we're exploring the opportunity to dose it less frequently, and of course that depends on the volume, which may require additional device or devices.

Ludwig Hantson -- Chief Executive Officer

And the device, we show you the device during the IRR Day. It was the -- we're a small dose drug delivery platform and the volume for that device was 3.5 ml. And maybe you remember that John was on stage using one of those device, they didn't had needle.

John Orloff -- Executive Vice President, Head of Research and Development

With the needle-free version, yes.

Ludwig Hantson -- Chief Executive Officer

Yes. They didn't have the needle and no product in it. I hope that answers the question. So we're going to stop the call. So needless to say that, I'm really pleased with the start of the year. As you heard ULTOMIRIS is off to a great start, MG continues to do very well and we continue to see great progress with our pipeline. We have a strong momentum in objective as to continue to do so. I can tell you, I'm very, very proud of the Alexion team, so I want to thank all of our colleagues for what they've done. And I wish you a good day. So enjoy the rest of your day, everybody. Thank you so much.

Operator

This concludes today's call. You may now disconnect. Everyone, have a great day.

Duration: 64 minutes

Call participants:

Susan Altschuller -- Vice President, Investor Relations

Ludwig Hantson -- Chief Executive Officer

Paul Clancy -- Executive Vice President, Chief Financial Officer

John Orloff -- Executive Vice President, Head of Research and Development

Brian Goff -- Executive Vice President, Chief Commercial Officer

Geoff Meacham -- Barclays -- Analyst

Kennen MacKay -- RBC Capital Markets -- Analyst

Geoffrey Porges -- SVB Leerink -- Analyst

Paul Matteis -- Stifel -- Analyst

Chris Raymond -- Piper Jeffrey -- Analyst

Unidentified Participant -- -- Analyst

Phil Nadeau -- Cowen and Company -- Analyst

Josh Schimmer -- Evercore ISI -- Analyst

Matthew Harrison -- Morgan Stanley -- Analyst

Robyn Karnauskas -- Citi -- Analyst

Steven Seedhouse -- Raymond James -- Analyst

Ying Huang -- Bank of America Merrill Lynch. -- Analyst

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