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Executives

Irving Adler - Executive Director of Corporate Communications

Leonard Bell - Co-Founder, Chief Executive Officer, Treasurer and Director

Vikas Sinha - Chief Financial Officer and Executive Vice President

David L. Hallal - Chief Commercial Officer and Executive Vice President

Martin MacKay - Global Head of Research & Development and Executive Vice President

Analysts

Eric Schmidt - Cowen and Company, LLC, Research Division

Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division

Rachel L. McMinn - BofA Merrill Lynch, Research Division

Ying Huang - Barclays Capital, Research Division

Salveen J. Richter - Canaccord Genuity, Research Division

David Friedman - Morgan Stanley, Research Division

Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division

Brian Corey Abrahams - Wells Fargo Securities, LLC, Research Division

Matthew Roden - UBS Investment Bank, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

Howard Liang - Leerink Swann LLC, Research Division

Terence C. Flynn - Goldman Sachs Group Inc., Research Division

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

Yaron Werber - Citigroup Inc, Research Division

Joshua E. Schimmer - Piper Jaffray Companies, Research Division

Alexion Pharmaceuticals (ALXN) Q4 2013 Earnings Call January 30, 2014 10:00 AM ET

Operator

Good morning, and welcome to the Alexion Pharmaceuticals Incorporated Fourth Quarter 2013 Results Conference Call. Today's call is being recorded. For opening remarks and introductions, I'd like to turn the call over to Mr. Irving Adler, Executive Director, Corporate Communications. Go ahead, sir.

Irving Adler

Thank you, Whitney. Good morning, and thanks, everyone, for joining us on today's call to discuss Alexion's performance for the fourth quarter of 2013 and our outlook for 2014. Today's call will be led Dr. Leonard Bell, our Chief Executive Officer. Lenny will be joined by members of Alexion management: Vikas Sinha, Executive Vice President and Chief Financial Officer; David Hallal, Executive Vice President and Chief Commercial Officer; Martin MacKay, Executive Vice President and Global Head of R&D; Steve Squinto, Executive Vice President and Chief Global Operations Officer; and Saqib Islam, Senior Vice President and Chief Strategy and Portfolio Officer.

Before we begin, I'd like to note that during this call, we will make forward-looking statements, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause our actual results to differ materially from these statements. A description of these risks can be found in our most recent 10-Q and 10-K filings with the SEC. Any forward-looking statements apply only as of today's date, and we undertake no duty to update any of these statements after this call.

I'd also like to remind you that our reported non-GAAP operating results are adjusted from our U.S. GAAP operating results for certain items that we described in our press release issued this morning. A reconciliation of our GAAP to non-GAAP results is included in the release.

Thank you. Lenny?

Leonard Bell

Thank you, Irving. With focus execution in Q4, Alexion's global team achieved a strong finish to 2013, which positions us to reach an even broader and higher range of commercial and clinical milestones in 2014 and the years ahead. Our accomplishments in 2013 and our expectations for 2014 are driven by the urgency of our mission to develop and deliver life-transforming therapies for patients with devastating and life-threatening disorders that are also ultra-rare.

Our fourth quarter performance underscored our strategic growth initiatives. First, our commercial team provided Soliris to an increasing number of patients with PNH and aHUS worldwide and broadened the base in which we will serve more patients in 2014 and beyond.

Second. Our R&D team advanced our current lead development programs toward a potential of as many as 7 anticipated product approvals with Soliris and other highly innovative therapies starting in 2014.

Looking first on our PNH operations during Q4. We, again, continue to demonstrate strong Soliris growth in our core territories with increasing contribution from the next group of major countries, including Turkey, Russia and Brazil. In 2014, we will go deeper in each of these countries, while also increasing our presence to serve more patients across our nearly 50-country platform. We are driven in these efforts by the knowledge that globally, the majority of patients with PNH have yet to receive an accurate diagnosis, let alone began appropriate therapy.

Turning to our aHUS launch. In Q4, we again observed a steady addition of new patients in the United States, made continued progress in key European countries and initiated aHUS commercial operations in Japan, following our marketing approval late last year. The ongoing strength of the global aHUS launch in the United States and other countries reinforces our confidence that our opportunity to serve patients with aHUS is at least as large as our opportunity to serve patients with PNH, and perhaps larger. As one measure, we continue to observe that match for the time since their respective approvals, more patients in the United States are currently receiving Soliris for aHUS than there had been for PNH. These results support our belief that the incidence of aHUS is higher than that of PNH.

In 2014, we expect to continue to extend our aHUS initiatives in the United States, complete the aHUS reimbursement processes across Western Europe, achieve a robust launch in Japan on our first full year of aHUS operations, and build on our initial presence in Turkey, Russia and Brazil.

Turning to R&D, during Q4, we made significant progress across all of our lead development programs. In 2014, we are now well positioned to achieve 10 or more development milestones. As Martin will describe further, these include, in HPP, our U.S, EU and Japan filings for marketing approval for asfotase alfa.

In AMR: the completion of enrollment and dosing in both, our ongoing living-donor study, and our newly expanded diseased-donor study. For DGF, NMO and MG: significant advances in enrollment of the single registration study in each of these indications.

For cPMP: completion of the retrospective study, completion of enrollment in the natural history study, and initiation of the synthetic cPMP bridging study.

For ALXN1007: the initiation of 2 Phase II proof-of-concept clinical studies in patients with 2 different severe and ultra-rare disorders with initial data from at least 1 of these indications by year end.

And finally, turning to our next-generation Soliris candidates, we expect to initiate clinical studies with 2 or more molecules in 2014.

Our 2014 development milestones are all important steps toward our anticipated series of as many as 7 potential major product approvals between 2014 and 2018, starting with our second product, asfotase alfa near late 2014, and then followed by Soliris for AMR and DGF and kidney transplant, and for both NMO and MG; our third product, cPMP for infants with MoCD Type A, and we expect approval of 1 or more of our next-generation follow-on products to Soliris within the same 2014 to 2018 period.

Beyond our current late-stage clinical development programs, we were pleased to recently announce a significant expansion of our research capabilities through our broad and long-term exclusive strategic agreement with Moderna, with the discovery and development of messenger RNA Therapeutics to treat patients with rare diseases.

Since rare disorders are most commonly caused by protein deficiencies, this innovative mRNA drug discovery platform optimally positions Alexion to address the broadest number of severe and rare conditions. Martin will provide more information on this program later in the call.

Over our 20-year history, and as we continue to grow strongly here in the United States, we have been focused on building a strong and independent organization. That will always have as its core mission the emphasis on patient care.

To this end, during Q4, we also reached an important milestone in our expanded service to patients around the world with the expansion of our technical operations and the opening of our global supply chain and quality facility in Ireland. I am pleased to note that as part of this expansion, we have recently agreed to purchase a vialing facility in Ireland. Following the appropriate validation processes and regulatory approval, this will become Alexion's first company-owned vialing facility for Soliris and our other clinical and commercial products.

As we centralize our global supply chain operations in Ireland, we also expect greater operational efficiencies, which Vikas will discuss later in the call. Separately, we have begun to distribute Soliris from our newly-approved contract manufacturing facility in Singapore.

Finally, we are pleased with the continued improvements in our Rhode Island manufacturing and quality operations and look forward to the FDA reinspection of this facility in the first half of 2014.

Turning briefly to our financial performance. Our 2013 results reflected 37% growth in revenues and 47% growth in non-GAAP EPS year-over-year. Moreover, towards the end of 2013, we realigned our global structure to facilitate stronger growth and more efficient performance in the years ahead. Our 2014 guidance reflects both our strong top-line and bottom-line growth forecasts.

At this point, I'll turn the call over to Vikas for a closer look at our financial performance in Q4 and 2013, and our expectations for 2014. Vikas?

Vikas Sinha

Thanks, Lenny. The fourth quarter of 2013 was another period of sustained growth in revenues and profitability for Alexion and provided a strong finish to the year. Revenue in Q4 increased 38% year-on-year to $441.9 million, representing a strong ongoing growth in established market, augmented by initial contributions from aHUS in Japan and Russia, following approvals in these countries in late Q3 2013. For the full year 2013, we recorded sales of $1.55 billion, an increase of 37% compared to 2012.

Looking at the geographic breakdown of sales in 2013: the U.S. contributed 36% of revenue; Europe, 33%; Asia Pacific, 13%; and rest of world, 18%.

Year-on-year revenue growth was robust across all our territories in 2013. Compared to 2012, U.S. sales increased by 40%, Europe by 23%, Asia Pacific by 26%, and rest of world increased by 76%. The growth rate in Europe was impacted by the fact that we did not have a full year of aHUS revenue in any European country. As a result of exceeding our revenue target, while maintaining strict financial discipline in our growing commercial and clinical activities, we were able to report 2013 non-GAAP EPS of $3.8 per diluted share, an increase of 47% year-on-year.

Looking at our balance sheet. Cash, cash equivalents and marketable securities at quarter end grew by $212 million to $1.52 billion, reflecting continued strong positive cash flow from operations.

I would like to review some individual line items with regard to Q4 and 2013, starting with cost of goods. In November, we announced our intention to record an additional expense in cost of goods resulting from the replacement of certain inventory. Compared to our previous estimate of as much as $25 million, we recorded an expense of $14.3 million in cost of goods in Q4. During Q4, this increase in cost was partially mitigated by the benefit of the lower cost of goods shipped from our contract facility in Singapore. As a result, cost of goods was 11.5% in Q4 and 10.6% for the year.

Our Q4 non-GAAP results excluded $33.5 million related to an impairment of early-stage assets. Also in Q4, and importantly, to build a platform for long-term operating efficiency, we incurred an incremental noncash tax expense of approximately $96 million by centralizing and optimizing of global supply chain and business operation within our Irish affiliates. We expect this realignment of our operations to bring a significant operational and financial efficiencies beginning in 2014.

I would now like to turn to our 2014 guidance. First, we are again guiding strong top-line year-on-year revenue growth. Revenues for 2014 are forecasted in a range of $2 billion to $2,020,000,000, an increase of approximately 30% year-on-year. 2014 guidance reflects our expectation for continued strong organic growth. As in past years, sequential growth in Q1 will be lower than Q4, reflecting fewer treatment days in Q1. In addition, we do not expect any meaningful new country initiations in Q1 2014.

Second, our forecast for 2014 SG&A expense of $560 million to $500 million -- $560 million to $580 million will be approximately 28% of sales. Our 2014 guidance includes the expense associated with the build-out of our metabolic therapeutic area in anticipation of a robust HPP launch.

Third, our non-GAAP R&D guidance in 2014 is forecasted in the range of $360 million to $380 million, which is approximately 18% of sales, as we pursue the broadest pipeline in our history to support future product approvals and launches. Q1 non-GAAP results will exclude $100 million related to our strategic agreement with Moderna, which will be recorded for GAAP purposes only.

Fourth, as we guided this morning, we expect our cost of goods sold to be reduced to approximately 9% in 2014.

Fifth, looking at our 2014 tax guidance, we have taken several steps to create a platform to continuously achieve greater operational and financial efficiencies. We now expect that our non-GAAP tax rate will be approximately 10% to 11%, reflecting our more efficient global structure and the utilization of available tax credits. Following utilization of our remaining tax credits, we expect that our non-GAAP tax rate will gradually rise to a range of 16% to 18% by 2016.

Finally, with regard to our 2014 guidance, by continuing to strongly grow revenues while maintaining our financial discipline, we are providing 2014 non-GAAP EPS guidance of $3.70 to $3.80. This forecast is based on an average of 205 million shares outstanding during the year. We are very pleased with our financial performance in 2013 and our robust outlook for 2014.

At this point, I'll turn the call over to David, who will provide an update of our global commercial operations. David?

David L. Hallal

Thanks, Vikas. During 2013, we achieved strong Soliris revenue growth of 37%, reflecting continued steady growth in PNH and our ongoing strong launch at aHUS in initial countries.

Looking first at PNH. We continue to grow our PNH operations by achieving deeper penetration in the nearly 50 countries in which we serve patients, with key countries benefiting from field team expansions deployed for the aHUS launch.

Importantly, throughout 2013, we continued to identify new patients with PNH each quarter, even in our longest established territories. Looking specifically at Q4, strong rates of patient identification and rapid treatment initiation with Soliris continued as in prior quarters, as our disease awareness and diagnostic programs continue to support optimal patient care. We were pleased with our performance in our core territories of the U.S., Western Europe and Japan; saw a steady growth in Turkey, Brazil and Russia; and continued to serve new patients in Korea and Latin America. In 2014, we expect that our efforts will result in more patients being rapidly diagnosed and treated in both established and newer markets and continue to selectively broaden our footprint to address opportunities in Latin America, Europe and Asia Pacific.

We are optimistic about our growth potential in PNH, as globally, the majority of patients with PNH have yet to receive an accurate diagnosis, let alone commenced appropriate therapy. In aHUS, we were pleased with the strength of the early stages of our global launch in 2013, and we are continuing this momentum in 2014.

In Q4, our disease education and diagnostic initiatives again resulted in a steady increase in a number of new patients in the U.S. commencing Soliris therapy, as well as the steady addition of new patients in the major countries of Western Europe, where we have established reimbursement. We added a significant number of new patients in Western Europe during 2013, even though we did not have a full year of reimbursement in any individual country. During 2013, we made significant progress to establish reimbursement for aHUS. And in 2014, we look forward to our first full year of serving patients with aHUS in several major European countries.

Looking more closely at our progress in key European countries. Starting with England, new and existing aHUS patients are receiving Soliris through a very broad funding policy commissioned by NHS England in Q3, which we expect will form the basis of ongoing access to Soliris. The NICE process is ongoing, and the decision is anticipated later in 2014.

In Germany, in Q4, we were very pleased that the government announced a rollback of the mandatory rebate on pharmaceuticals. The 16% rebate will revert back to the original level of 6% in Q1 2014 and then increase slightly to 7%. We are also pleased that we continue to see an increasing number of aHUS patients in Germany diagnosed and treated by nephrologist and hematologists.

In Spain, we are beginning the reimbursement processes in individual provinces, following a national agreement with the federal government regarding the use of Soliris for patients with aHUS at the end of Q3.

Elsewhere in Europe, in France, we continue to advance reimbursement discussions with the government and expect these discussions to conclude by mid-2014.

In Italy, while the government continues to provide Soliris through an early access program, we also expect to complete the reimbursement process by mid-2014 to enable a full commercial launch. Also, in our EMEA region, we continued to observe steady growth in serving new aHUS patients in Turkey in Q4.

Beyond EMEA, we've reached an important milestone as we served initial patients with aHUS in Japan, and now expect to execute on a robust launch in our first full year of aHUS operations in Japan.

The ongoing strength of the global aHUS launch continues to reaffirm our view that our opportunity to serve patients with aHUS is at least as large as our opportunity to serve patients with PNH, and perhaps larger. As one measure, we continue to observe that match for time. Since their respective approvals, more patients in the U.S. are currently receiving Soliris for aHUS than there had been for PNH. These results support our belief that the incidence of aHUS is higher than the incidence of PNH.

Beyond our current commercial operations, I would like to now turn to our preparations for a robust launch with asfotase alfa for patients with hypophosphatasia, or HPP. Importantly, our market research confirms our understanding, reflected in the FDA's Breakthrough Therapy designation that age of onset is a key clinical indicator for the need to provide a transformative treatment. As we continue to establish our metabolic therapeutic area for our anticipated launch near late 2014, we have now added our initial field-based medical teams in the U.S. and Western Europe. At launch, we will be prepared to serve all patients with pediatric onset HPP, including adults. Additionally, we continue to recognize the importance of continuing to understand the needs of patients with adult onset HPP. For all patients with HPP, our metabolic therapeutic area is leveraging our learnings and expertise in PNH and aHUS to develop commercial programs to support the HPP community. Beyond planning for the launch of asfotase alfa, we are beginning to establish commercial teams to assess and plan for the opportunities in AMR, DGF, NMO, MG, and the next-generation Soliris molecules. These teams will work closely with our R&D colleagues as they advance these programs through the development process.

At this point, I'll turn the call over to Martin for a look at our development programs. Martin?

Martin MacKay

Thanks, David. I am pleased to provide an update on our lead development programs. We are currently aiming for up to 7 potential launches between 2014 and 2018. In addition, I will discuss our strategic agreement with Moderna, a key step towards expanding our research capabilities to serve additional patients with severe and rare disorders and to drive growth well into the 2020s. In keeping with our tight focus with regards to target disorders and therapeutic candidates, all of our programs are focused on devastating and life-threatening disorders affecting extremely small patient populations. And our therapeutic candidates have the potential to deliver a transformative impact on patients' lives.

To begin, I would like to discuss the progress of our development programs with eculizumab, starting with our studies in antibody-mediated rejection, or AMR, in kidney transplant patients. We have now made significant progress towards completing enrollment in our living-donor study, and we expect to complete enrollment in this study in Q1. We also continue to enroll patients in our expanded deceased-donor study, and expect to complete enrollment this summer.

Also in the area of transplant, and as we announced last week, the FDA has granted orphan drug designation to eculizumab for the prevention of delayed graft function, or DGF, in renal transplant patients. DGF is an early and serious competition of organ transplantation that is characterized by the failure of a transplanted organ to function normally immediately following transplantation, requiring that the patient undergo dialysis in order to survive. There is currently no approved therapy for kidney-transplant patients who develop DGF. In addition, a significant number of donor kidneys are reportedly discarded each year due to the risk of poor outcomes associated with DGF. Following positive discussions with regulators in the U.S. and EU, we expect to initiate a single multinational DGF registration trial in mid-2014.

Turning now to neurology. Our program in neuromyelitis optica, or NMO, is on track, as we prepare to commence a single registration trial with eculizumab in relapsing NMO in the first quarter of 2014. This will be a double-blind, placebo-controlled, multicenter study, with the primary outcome measure of time to relapse. As previously discussed, the study design now aligns more closely with the thinking of leading practitioners and is focused on patients who continue to have relapses, regardless of which therapy or therapies they may have received.

In refractory myasthenia gravis, or MG, we will also initiate a single registration trial in Q1. This will be a double-blind, placebo-controlled, multicenter study in which the primary outcome is change in total MG-ADLs score from baseline to Week 26. A measure of patient outcomes aligns with our discussions with regulators.

Finally, with regards to lifecycle management of Soliris, well through the 2020s, we expect to initiate clinical studies with 2 or more next-generation Soliris molecules in 2014, with another molecule at an earlier stage of development.

I will now turn to our lead development programs with our highly innovative therapies beyond eculizumab, starting with asfotase alfa. We continue to benefit from the Breakthrough Therapy designation received from the FDA, as we look to complete our registration program for pediatric-onset hypophosphatasia, or HPP. Importantly, we have also now had productive discussions with both EMA and PMDA regarding our HPP program.

The analysis of our infant natural history study continues to be strongly supportive of our anticipated filing, and we have now initiated a natural history study in juveniles with HPP. We remain on track to file for our initial marketing authorization in HPP in the U.S. and Europe by mid-2014, and we also expect to file for approval in Japan near the end of 2014.

Further in our metabolic disease area, we continue to accelerate the development of our cPMP replacement therapy for the treatment of patients with molybdenum cofactor deficiency Type A, an ultra-rare, genetic metabolic disorder that causes catastrophic, neurologic damage in newborns. In 2014, we expect to drive this program forward on 3 levels: Completion of both the retrospective data collection and enrollment in the natural history study, and the initiation of a synthetic cPMP bridging study in the first quarter of 2014.

With regard to ALXN1007, our novel anti-inflammatory antibody, we expect to conduct parallel development in 2 severe and ultra-rare conditions. Following our meeting with regulators, we will initiate the Phase II proof-of-concept clinical studies in Q1, and expect to have initial data near year end and at least 1 condition.

Beyond our current clinical development programs, we were pleased to recently announce a significant expansion of our research capabilities through our long-term exclusive strategic agreement with Moderna for the discovery and development of messenger RNA therapeutics to treat patients with rare diseases. This innovative drug discovery platform optimally positions Alexion to address the broadest number of severe and rare disorders, which are most commonly caused by protein deficiencies. As part of our exclusive strategic agreement, we have the ability to cycle through many different potential rare disease targets to pick the optimal one for development. In this context, we have already identified a large number of targets relevant to rare and severe disorders.

Our relationship with Moderna is structured so that each party can focus on what it does best. They will design and manufacture mRNA therapeutic candidates based on targets we identify, and we will lead the discovery, development and commercialization of the treatments that are produced. We look forward to providing further updates on these programs on future calls.

As we look ahead in 2014, we are expecting 10 or more development milestones in our in-house programs whilst also enhancing our R&D capabilities through disciplined research collaborations, licensing and acquisitions. Our strong focus remains on developing therapeutic candidates with life-transforming potential for patients with rare and severe disorders.

I will now turn the call back to Lenny. Lenny?

Leonard Bell

Thank you, Martin. 2013 was a year of strong performance for Alexion across a growing number of commercial and clinical objectives. In 2014, we will build on our recent accomplishments as we seek to serve more patients with PNH and aHUS worldwide, prepare for a robust launch in HPP, reach a wide range of milestones across our lead development programs, and aggressively push forward the frontiers of scientific discovery for the benefit of patients with severe and rare disorders.

As always, we thank our employees for their dedication to our mission, as we work to transform the lives of patients.

Operator, we'll now take questions.

Question-and-Answer Session

Operator

[Operator Instructions] And will take our first question from Eric Schmidt with Cowen & Company.

Eric Schmidt - Cowen and Company, LLC, Research Division

First, across all the facets of the organization, a question for Vikas maybe on the business operation transfer to Ireland. Can you talk mechanically about what's maybe going on there? Are you transferring IP to Ireland? And in terms of the cash you'll be generating, is that going to be domiciled in Ireland? Would that be available for things like M&A or future dividend payments? Would you have to pay taxes if you were to repatriate that cash, et cetera?

Leonard Bell

Eric, its Lenny. Thank you very much for that question. Let me start out by giving some context, and then actually I'll turn the rest of the response to Vikas. Over our 20-year history and as we continue to grow strongly here in the United States, as I mentioned earlier, we have been focused on building a strong and independent organization. That will always have as its core its mission and emphasis on patient care. In addition to our relentless focus on the development of innovative therapies, we also recognize our need to achieve increased operational efficiency in order to optimally serve patients worldwide. As we highlighted earlier, we've recently reached important milestones in the centralization of our technical operations with the opening of our global supply chain facility and agreement to purchase a the vialing facility in Ireland. During 2013, we have developed a substantial presence in quality, technical operations and global supply chain in Ireland. Already in 2014, as I mentioned, our presence is further accelerating as we made our agreement to purchase and now operate a vialing facility in Ireland. As our quality, technical operations, global supply chain and vialing facilities come online, they are designed to provide further support for patients in Europe and around the world. In addition, our increasing investment in Singapore production further improves our cost structure and strengthens our global supply chain. The tax rate guidance that we are giving this morning reflects the changes we have made for our operations to accommodate this substantial growth in our global business. Importantly, this increase is efficiency will enable us to continue to investing in our expanding research initiatives as well as the global introductions of innovative therapies to serve patients around the world. For more details, Vikas?

Vikas Sinha

So Eric, further to what Lenny pointed out, the tax rate guidance we gave this morning reflects the changes we have made to our operations to accommodate the substantial growth in our business. In order to accomplish these objectives in Q4, we incurred an incremental noncash tax expense of approximately $96 million as we centralized our global supply chain and business operation within our Irish affiliates, right? And as part of the centralization of our business, effective 2014, our Irish affiliates will hold certain IP rights to Soliris and other compounds. Now going to the -- towards the math portion of this, as you'll recall, we had $454 million in NOLs and $65.3 million in tax credits at the beginning of 2013. During Q4, we created additional foreign tax credits as we centralize business operations within our Irish affiliates. At the end of 2013, we have approximately $9 million of NOLs and approximately $190 million in tax credits remaining. We will use these foreign tax credits to offset our taxable profits beginning in 2014. As a result, 2014 non-GAAP tax rate will be approximately 11% to 12% in 2014. And then in 2015, it will be 13% to 14%. And then it'll rise to 16% to 18% in 2016 and beyond. I hope that answers your question.

Eric Schmidt - Cowen and Company, LLC, Research Division

Well, what about the cash domiciled, Vikas?

Vikas Sinha

Yes, so cash domicile-wise, for acquisition purposes, I think we have a good opportunity to do it from either subsidiary or in terms of providing buyback opportunities to cover the dilution. And in the future, if there's a need for providing dividends, which we don't have an intention at this point, we will have enough cash that will come in to U.S.

Leonard Bell

Yes, 2 things to clarify. One is the -- again, as we provided our guidance this morning, the -- we anticipate the 2014 non-GAAP tax rate to be approximately 10% to 11%, then moving up as we exhaust some of our tax credits to 13% to 14% in 2015. And then from 2016 for the foreseeable future forward, 16% to 18%. Second, actually, we also anticipate having sufficient capacity to really build the organization globally and strategically as well from the United States and from all of our affiliates. So we don't feel constrained anywhere.

Operator

We'll take our next question from Geoff Meacham with JPMorgan.

Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division

I know you guys were working on, for asfotase, the optimizing and manufacturing process but I wasn't sure what stage was this -- this was in. And then just curious, do you think that your changes to the manufacturing will require a label amendment down the road, if you have to run some sort of bridging study? And then I have just one quick follow-up on the pack.

David L. Hallal

Yes, we actually have made a firm amount progress in creating a second-generation manufacturing process for asfotase alfa. I think at this point, it's a little bit too early to determine what the regulatory strategy will be. As we learn more about the next-generation molecule and better characterization around that molecule, we'll be able to identify better how the regulatory path will play out.

Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division

That's good. And then just to confirm, I know the cost on the new tax structure, just to confirm it, if that include asfotase, future indications of Soliris, et cetera, et cetera.

Vikas Sinha

Yes.

Operator

We'll take our next question from Rachel McMinn with Bank of America Merrill Lynch.

Rachel L. McMinn - BofA Merrill Lynch, Research Division

I was hoping to ask a question where Lenny couldn't read from the scripts. For aHUS, I know you've not really provided a lot of granularity but was hoping you could give us a sense. Is it somewhere around 20% of sales? It looks like you had such a big uptick in U.S. sales growth for the year that a lot of that has got to be attributed to it. I just wanted to get a ballpark number, if I'm thinking about it correctly. And then, again, capital allocation for R&D in the past, you talked about that being in and around 18% of sales. But as you look at the pipeline today, do you think that you have enough programs to really achieve that goal? Or should we be thinking about a lot of deals going forward to help support your longer-term growth goals?

Leonard Bell

So I'll take the first question, which has something to do with the aHUS versus PNH and then the second question, Martin will take. So as I think that people have noticed, obviously, you can see the bump up in our reported U.S. sales in 2012 over 2011, which actually reflects then the addition at the end of 2011 of aHUS in the United States, the PNH agent. And we think that's indicative, frankly, if one backs that out of the preceding several years of year-on-year absolute growth of how much aHUS contributed versus how much PNH contributed. We have further made a comment that outside the United States, we really have not had one full year of sales in any country following all of our discussions, and we anticipate that this will further serve patients as we move forward during the remainder of this year. We think as well, as we note, that overall looking at the United States, and certainly as we mentioned, David and I both mentioned earlier, is that as well as other countries, we think that, that time for time, aHUS to PNH, there are more patients typically on a treatment but at the same time post approval in those countries where we're fully active. And we think that indicates, as we mentioned, that we believe the incidence of aHUS is higher than PNH. Martin, would you like to discuss R&D and our strategic approaches there?

Martin MacKay

Yes, thank you. Thank you, Lenny. Yes, Rachel, in terms of 2014, from a development part, is certainly a busy year if I think about the filing of asfotase alfa, the completion of the living-donor, deceased-donor trial and AMR, and we have several starts, as you know, from NMO, MG, DGF, the bridging cPMP study, 2 programs with ALXN1007 and then, of course, our next generation. However, I believe that our budget is very well positioned to be able to prosecute this portfolio. So that said, top of my mind to deliver those programs. The other part you raised is a good one, though in terms of looking at other things and as I mentioned in the script, whether it be research, collaborations or acquisitions or licensing, we're very active in this field, looking to bring those things in. And we will handle the budget accordingly.

Operator

We'll take our next question from Ying Huang with Barclays.

Ying Huang - Barclays Capital, Research Division

So first one, can you talk a little bit about the average aHUS dosing for Soliris now? So now we can have an idea like, on average, what the age group is for the current patients receiving Soliris. And then secondly, I was hoping Martin can give a little bit more clarity on the Moderna collaboration in terms of which indications you guys might be looking at? And then how is this messenger RNA delivered?

David L. Hallal

Yes, Ying, it's David. I'll take your first question. The way to think about aHUS is that on average, across the children and adults, it reflects very similarly to that of PNH. Some of the adults, obviously, that we have on treatment or all of the adults are on the higher dose as reflected in our labels. But of course, because we're serving children as well, on average, it squares up with PNH.

Martin MacKay

Well, thank you, Ying, for your question on Moderna. I'd say a couple of things. As you probably know, the key finding here that really underpins the technology was the ability to inject modified RNA in animals to avoid the immune system and actually produce proteins at potentially therapeutic levels. And the Moderna scientists have shown in vivo that you can make these therapeutic levels of proteins via this mRNA technology. Of course, in our world, most of the diseases that we look at in the rare and ultra-rare space are caused by protein deficiencies, and therefore, a lack of a protein caused by some gene defect. So if you think about it, it's really a very good fit to apply this technology to the diseases that we are most interested in. And that's what we will prosecute. In terms of the types of diseases we're thinking of, literally, we have scores of diseases in the ultra-rare space that would fit the bill here for replacement proteins, and we're working through these diligently now to select a number of them that we'll be able to test with the technology. The really neat thing from my perspective is this is all really very testable. The ability to make the construct inject it, which is the answer to the last part of your question, and then test if you get those therapeutic proteins is all within the realms of what we do in the laboratory today. So very exciting technology and we're looking forward to addressing a number of disease targets.

Operator

We'll take our next question from Salveen Richter with Canaccord.

Salveen J. Richter - Canaccord Genuity, Research Division

Just a follow-up question on the tax credit. Just wondering, post 2016, should we expect non-GAAP taxes to go up to full tax rates? And then also, the cost, if you could give us an idea of the FX impact in Q4 and then your assumption for 2014 in guidance for FX and how we should think about Q1 given the yen and Australian dollar?

Vikas Sinha

Thanks, Salveen. The first one is in 2016, we will get to 16% to 18% range in taxes as we exhaust our foreign tax credit in '14 and '15. Relating to the foreign exchange, from Q3 to Q4, the pressure on yen was there and was slightly offset by the euro so we didn't see a significant impact going into Q4. But when we go from Q4 to Q1, the yen and the commodity currencies there are under tremendous pressure right now, and we will definitely see pressure going into Q1 from Q4 2013. And as a reminder, Q1 always has 2 fewer shipping days. So between that and the FX, we see that impact also if you compare it to the last year and the year before. We see that impact coming in, in Q1 also. So those 2 factors will impact our Q1, namely 2 fewer days and yen and Aussie dollars from commodity currencies.

Salveen J. Richter - Canaccord Genuity, Research Division

Okay. And then -- so then, Vikas, the tax credits will run out in 2016 and we should expect tax rates to kind of go up towards the 32% range or so as we go to 2017 onwards?

Vikas Sinha

No, no, no. Salveen, 16.8 -- 16% to 18% will be 2016 and beyond. So it will not go up. And then I will -- so from the GAAP tax rate perspective also, I don't expect GAAP tax rate to be more than 3%, 4%, more than that.

Operator

[Operator Instructions] We'll take our next question from David Friedman with Morgan Stanley.

David Friedman - Morgan Stanley, Research Division

It's on the delayed-graft function. I was wondering if you could discuss, a, are we going to be any of the delayed-graft function data of this year? And then, b, in terms of the planning for Phase III, are you thinking about dosing more along the lines of what you're using for acute rejection or more along the lines of some of the investigator sort of studies or some of the discussions around single dosing or a couple of doses?

Martin MacKay

Thank you, David. In answer to 2 parts of your question, in terms of when we will expect to see some data, clearly, that we look the data that's coming out of the AMR studies, living-donor and deceased-donor over the next period. Clearly, the DGF trial itself, which is the randomized double-blind eculizumab versus placebo, we'll not have that data for some time. We aim to start that study in the middle of the year. And I think as you know, the primary endpoint there is incidence of DGF following posttransplantation. Obviously, our aim is to start in 2014. In terms of the dosing, we expect that to run along more of the lines of the AMR. Clearly, we've looked very carefully at the investigator studies and are continuing to work through that. Hope that answers both questions.

David Friedman - Morgan Stanley, Research Division

I guess, just to clarify that. Will we see some of the data that you've generated to date this year? Or is that not to be?

Martin MacKay

We're still working through that actually, David. As I mentioned, maybe mentioned in the script, it's something that we are considering given that we will complete the living-donor data in the first quarter and aim to complete the deceased-donor, the expanded study that you remember from the 47 to 80 patients towards midyear. As we gather those data, then we'll make a decision about how we will externalize them.

Leonard Bell

Obviously, David, as well, the DGF is part of deceased-donor, which, as we mentioned, now, as Martin said, is being expanded. So we're hustling, of course, and we're very grateful to all the investigators as they try to rapidly enroll the increased number.

Operator

We'll take our next question from Chris Raymond from Robert Baird.

Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division

Lenny, just a question on the Moderna deal. As I recall, you had a few things to say about RNAi as a technology. Maybe in the context of those comments, can you maybe talk a little what drew you to mRNA? And specifically, on Moderna, we've done a little bit of work on this, and I think they've got some really good direct injection data. But could you maybe comment on sort of the plan going forward for a systemic delivery?

Leonard Bell

Yes, I'll make an initial comments and then I'll defer to Martin for sure. I think that as we look at the scope of patients suffering with devastating disorders that are within the filter that we look to address, the overwhelming majority of these conditions, as Martin mentioned, are really caused by protein deficiency. And so we look at the end how we're looking to help a patient -- how we're looking to help the patients with the most devastating disorders. As we then back up all the way to say what types of technologies would allow us to address the broadest group of those patients with the most severe and devastating disorders that are rare, it happens to be that technologies that cause increase in endogenous protein production are perfectly matched to the setting where almost the vast majority of rare, devastating disorders are caused by protein deficiencies. Certainly, there are patients who may have excess proteins. Certainly, oncology is a typical area where this is. Its overexpression and so forth. But when you look at devastating and rare disorders, the overwhelming majority of these severe conditions are caused by protein deficiencies by which the addition of mRNA as a template for protein or endogenous protein production, in our view, allows us to address the broadest group. Not to say that we don't have interest in a variety of different technologies to address different populations of patients, as we look at the platform, the broadest group would really be with something that accentuates protein production.

Martin MacKay

Nothing to add, Lenny. You've covered both points. It's not just this technology, its other technologies where we are looking at things being knocked down also. Basically, anything brought to bear on these devastating diseases.

Operator

We'll take our next question from Brian Abrahams with Wells Fargo.

Brian Corey Abrahams - Wells Fargo Securities, LLC, Research Division

I was wondering if you could talk about the latest on persistency rates in aHUS, how your educational efforts around all the data you've generated are resonating and if there's any regional differences in the level of understanding of the need for chronic therapy.

David L. Hallal

Yes, thank you, it's David. We sort of noted in past calls that our compliance rate with aHUS is solid. But it is less than we've historically observed in PNH. And as we described and discussed down at ASH, we were very pleased with new information at both ASN and ASH last year that was producing for the first time our 3-year data. So the impact of Soliris on those aHUS patients that were remaining on treatment for now up to and through 3 years. And I think what's important about that is it's giving physicians not only the comfort on the fact that patients are remaining TMA free, but there continues to be improvement in patient's renal function over that time. And so there's 2 risks associated with stopping patients early. One, of course, is the return of clinical manifestation of TMA that is outlined in our labels around the world, and those severe TMA complications are very dangerous to patients upwards and including the risk of death. And then secondly, the overall improvement of renal function as patients remain on treatment for the long run. And then secondly, at ASH, the biomarket data, which showed a large cohort of patients that were on treatment for 1 year, and that while Soliris had a dramatic impact on clinical outcomes, it also reduced all key levels of diseases measured by biomarkers except that. What we showed 1 year later was that complement alternative pathway was still elevated above the levels of normal, which highlights that without a terminal complement inhibitor on board, those patients are at risk. So we've gone out, we've started to educate many of the physicians on this new data and it is certainly resulting in a greater appreciation for the chronic nature of the disease. So early stages, but we want to bring the levels up.

Leonard Bell

Was there a second part that you wanted David to answer to that?

Brian Corey Abrahams - Wells Fargo Securities, LLC, Research Division

No, that's very clear.

Operator

We'll take our next question from Matt Roden with UBS.

Matthew Roden - UBS Investment Bank, Research Division

And I have to say, Vikas, consensus seems to be that if you ever wanted to do some moonlighting, that I'm sure there's lots of people in the investment community that would love to have you do their tax returns. In HPP, you've gotten a variation of this question before, I just want to get your latest thinking. Would it be correct to assume that the later the onset of disease, that the less severe the manifestations? We know there's a range of severity, but I'm just trying to get a sense for what the most appropriate patient population would be, and frankly, just trying to determine how far we should go in our models beyond the [indiscernible] onset population?

David L. Hallal

Yes, so I think what the Breakthrough Therapy designation highlighted and certainly what we are focused on is those patients with perinatal, infantile and juvenile onset were those patients that very much needed a transformative treatment. And that opens up the dialogue with the FDA and Martin's team even further on [indiscernible] patients faster. So what we do know though and our market research validates is there are adults with HPP that have been living with this disease since prior to the time that they were 18 years of age. And so it is the time and onset of first symptoms of HPP that can be very indicative of the severity in adults. And that's what we're focused on, is understanding that adult segment while not in any way, as I discussed in the script, ignoring the need that patients may have with adult-onset HPP as well. And so we're going to continue to work with the community. We're going to continue to work with all segments of the population and develop our launch strategies appropriately. Martin?

Martin MacKay

Yes, just to add to David's commentary. As time goes on, we're also understanding much more about the pathophysiology of the disease and understanding the onset piece and the age piece. And as David said, we know there are adults that have quite a serious form of hypophosphatasia.

Operator

We'll take our next question from Robyn Karnauskas with Deutsche Bank.

Robyn Karnauskas - Deutsche Bank AG, Research Division

I guess, on the aHUS side, you had mentioned at ASH that you're working toward increasing duration. How is that going? And on HPP adults, are there patients that are diagnosed after 18 that have a severe form as well or a subset of people that have a severe form? And why -- and what do you know about that population?

David L. Hallal

Sure. So I'll take on the aHUS piece and then have Martin address the HPP. So I think there's one key point about patient retention and compliance rates in aHUS and that is, as Lenny and I described on the call, the metric that we're using for time-adjusted numbers of patients on treatment with aHUS at the same point in which we had 4 PNH, being higher for aHUS, that is patients actively on treatment. So I think what that highlights is as we continue to progress and help physicians understand the long-term nature of the disease, we see great, really great leverage to try to improve patient outcomes and improve those patient numbers even further. But again, even with the compliance rates, which are not as high as we've come to expect with PNH, we still have a higher number of patients actively on treatment with aHUS as opposed to PNH. Martin?

Martin MacKay

Yes. Just briefly, Robyn, the database is relatively small at the moment, and as I mentioned earlier, we're really trying to understand the disease better across age groups. It certainly appears that today, most of the adults have onset earlier than 18. That's what we have seen. But again, much more work to be done there to truly understand this disease.

David L. Hallal

And then Robyn, I would just close. As we move toward our team getting more involved with HPP, with any ultra-rare disease, there's typically a misunderstanding as to which patients have the disease. So I would anticipate that as we extend our decease and diagnostic initiatives in HPP, there will be patients who are adults that, for the first time, physicians do evaluate their long-term medical history and onset of disease that will be diagnosed with HPP as an adult but will be validated as having pediatric-onset HPP because of greater awareness of the disease. So we're looking forward to making a significant impact there.

Operator

We'll take our next question from Howard Liang with Leerink.

Howard Liang - Leerink Swann LLC, Research Division

You talked about the incidence of aHUS is greater than PNH. I think also, obviously, you're converting the incidence to prevalence more for aHUS than for PNH. Can you talk about how you see the prevalence evolves over time for aHUS, and eventually, the prevalence of aHUS, how might that be relative to PNH?

David L. Hallal

Sure, Howard, thanks. So yes, I mean, as we introduce Soliris in any individual country at launch, because of the very, very high rates of ESRD and death associated with aHUS, there is typically not a very large prevalent pool of patients at all. But our belief is that on ongoing basis in any 12-month period, there would be more patients with initial symptoms and clinical manifestation of TMA with aHUS than there would be with PNH. And that is newly presenting symptoms and newly diagnosed, okay? It does not necessarily mean, and we are still focused on this, the growth opportunity, as I indicated, for PNH is still very, very high because patients have been living with the disease with symptoms that resemble other diseases. And through our efforts, we're able to identify new patients with PNH that, frankly, had symptoms of the disease for a longer period of time. So then how does all of this impact prevalence of aHUS? As we get there sooner with our efforts to enable patients to receive a rapid and accurate diagnosis and then gain access to treatment, obviously, the long-term outcomes associated with Soliris and aHUS are very positive and we would expect the number of patients then to increase, the prevalent pool to increase, because now they are not progressing to ESRD or death.

Operator

We'll take our next question from Terence Flynn with Goldman Sachs.

Terence C. Flynn - Goldman Sachs Group Inc., Research Division

I just had 2 because I'm guessing you aren't going to answer the first one. But any hint about 1007, either the target and/or the diseases you're going after? And if you guys aren't going to answer that one yet, then just wondering in terms of the business development efforts here going forward, if Moderna's the type of asset company we should think about so early stage platform or is still everything on the table as you continue to scour the landscape.

Unknown Executive

Lenny, do want to...

Leonard Bell

Martin, do want to answer 1b? Good.

Unknown Executive

Exactly, Lenny do not want to answer 1a first. Listen, Terence, I think that with respect to BD, I think Moderna certainly fits the bill from a technology standpoint and a quality standpoint. But it is not -- we aren't limiting ourselves to early stage or late stage. There will be products that we look at. There will be technology that we continue to look at, all within the filter that we're solving for a transformative effect in very life-threatening disorders. Sorry, I'm losing my voice here.

Martin MacKay

Yes, as regards to 1007, Terence, we will give more information as we progress with the trials, both in terms of mechanism and the 2 ultra-rare disorders that we are looking to start proof-of-concept studies in the first quarter.

Operator

We'll take our next question from Geoff Porges with Bernstein.

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

Look, Lenny, you've beaten us over the head with aHUS that's got to be bigger than PNH. So I'm not trying to prompt you to say that again, but could you help venture a similar sort of comparison for asfotase? Do you think, given what you've seen right now, that asfotase has the potential to be as large contributor, either in terms of to the company or in patient numbers to where you've achieved things with PNH?

Leonard Bell

Yes, it's a great question. Thank you for as asking, Geoff. I think it's really very early. Obviously, we're -- as David described, we're just creating -- and Martin described we're just creating our medical teams around the world to help physicians understand what HPP is. It's a very, very long road, given that very rare disorders, particularly ones that such a devastating outcome for patients and families like HPP. The knowledge in the identification of patients is really uncommon. But I think it's really way too early for us to project to you, if we ever were to, what we think that will be. As we can tell, we're keenly focused, obviously. We recognize clearly, no matter what, how devastating this disorder is and that's our first and foremost priority to address that.

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

Well, you should -- you might have to remind us about aHUS being as large as PNH again then.

Leonard Bell

Sorry, I might have to remind you about what?

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

aHUS being larger than PNH then. We've talked basically on that.

Leonard Bell

Yes -- no -- yes, as I said, I think we said it several times. I think it's indicative that, as David said, I said, David said and then I said, I think that there is -- clearly, match time for time, PNH approval versus aHUS approval in the United States and selected other countries. There are more patients currently actively receiving treatment with Soliris for their aHUS as opposed to PNH at the same time. Likewise, we have a great conviction at the incidence of aHUS, as David said, I said then David said and I said, again, it is actually higher for aHUS than it is for PNH. David, do want to do it again or...

David L. Hallal

I don't want to do it again. The only thing I'll state is that this is over a few years period of time in the U.S. So it is a long period of time. We're not looking at a single quarter.

Vikas Sinha

Let's take 2 more questions.

Operator

We'll take our next question from Yaron Werber with Citi.

Yaron Werber - Citigroup Inc, Research Division

Two questions. One, Vikas, for you, the benefits from Germany, the reduction in the rebate, is that something -- it sounds like it's going to start in Q1. Is that immediate, that the whole thing is going to a roll forward starting January? And I don't know if you can qualify for us how big is Germany. And then I just have a quick follow-up on HPP.

Vikas Sinha

So I'll take the first question. The German impact is across all the companies in Germany as all of you know about that. And so yes, the impact will start seeing the benefit from Q1 onwards for the full year or most likely full year, next year.

Leonard Bell

There's also a -- just the nuance which I'm not sure if we mentioned directly in the call earlier, but again, as Vikas said, it was across all companies serving patients in Germany. But in addition to that, there's a little bit of change that we expect to occur. So it goes from 16% down to 6% and then back up to 7% starting in the second quarter, the rebate.

Yaron Werber - Citigroup Inc, Research Division

And then Lenny, just for you. Can you give us a little bit of a sense, I mean, obviously, you guys are going to go aggressively with the alkaline phosphatase, asfotase alfa in the market to try to diagnose more patients. And it's probably going to be -- it's going to be more fruitful, obviously, in the patients who are a little bit older. So what -- is there -- was it -- even if it exists, a typical presentation for an adult who was diagnosed prior to age of 18, I'm trying to get a sense what's the profile of these kind of patients. And are they symptomatic against the drug?

David L. Hallal

Thanks, Yaron. Yes, so I think the one thing I'm hesitant to say about which is more fruitful, all patients with this disease, we are focused on. From a development perspective and a commercial perspective, when we get in, we're focused on the entire community and all of our efforts has got to be focused on really serving that community. In terms of how one might be diagnosed, I'll share one example, is you're looking at dysfunctional alk phos in these patients. And what's interesting is a lot of physicians don't necessarily even have in part of their diagnostic platform. When they see, say, a presentation of a patient with early tooth loss, frequent fractures, perhaps some organ involvement, they're not necessarily thinking about testing alk phos or when they do, they perhaps are looking for elevated levels of alk phos rather than low alk phos. And there's a very basic element of our diagnostic campaign that will help to shape, very much like we did with PNH and aHUS, help to shape the clinical presentation of patients, what diseases may overlap in terms of symptoms with HPP and then the simple, available, reliable and trusted diagnostic test available to those physicians so that they can make a differential diagnosis. And so there's a lot to learn and we look forward to providing more color on our efforts in future calls.

Operator

We'll take our last question from Josh Schimmer with Piper Jaffray.

Joshua E. Schimmer - Piper Jaffray Companies, Research Division

I guess my question is a little bit of a continuum of that. Have you begun screening any bone fragility disorder populations like osteogenesis imperfecta to identify HPP patients? How many -- any estimates for how many candidates for asfotase alfa you might be able to pick up in those settings?

David L. Hallal

Yes, it's just too early to tell. I will say though that we are working with the opinion leaders globally in the HPP community to gather their feedback on what we think can be the most effective diagnostic education programs to help physicians think about screening and testing the right patient.

Leonard Bell

As David is saying, clearly, there's a significant number of disorders that may get confused with hypophosphatasia. And certainly, as what we have done in other disorders, PNH for example or aHUS, sometimes it's helpful to frame for physicians to consider those other disorders by which physicians may get confused to give them a path to identify which one of them really have the critically severe disease, in this case, hypophosphatasia.

Operator

That was our last question, and this concludes today's conference call. Thank you for your participation. You may now disconnect.

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