Biogen Inc (BIIB) 2016 Q2 法說會逐字稿

Good morning.

My name is Dan, and I will be your conference operator today.

At this time, I would like to welcome everyone to the Biogen second-quarter 2016 financial results and business update.

(Operator Instructions)

Thank you.

I would now like to turn the call over to Mr. Matt Calistri, Senior Director of Investor Relations.

Please go ahead.

Thanks, Dan.

Thank you, everyone, and welcome to Biogen's second-quarter 2016 earnings conference call.

Before we begin, I encourage everyone to go to the investors section of Biogen.com to find the press release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we'll discuss today.

Our GAAP financials are provided in tables 1 and 2.

Table 3 includes a reconciliation of our GAAP to non-GAAP financial results.

We believe non-GAAP financial results better represent the ongoing economics of our Business, and reflect how we manage the Business internally.

We have also posted slides on our website that follow the discussions related to this call.

I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs.

These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

I encourage you to consult our SEC filings for additional details.

On today's call, I'm joined by our Chief Executive Officer, Dr. George Scangos; Dr. Michael Ehlers, EVP of Research and Development; our Chief Commercial Officer, Michel Vounatsos; and our CFO, Paul Clancy.

We'll also be joined for the Q&A portion of the call by our Chief Medical Officer, Dr. Al Sandrock.

Now I'll turn the call over to George.

Okay.

Thank you, Matt, and good morning to everyone.

Thanks for joining us.

I'd like to begin with a personal statement.

I'll be stepping down as CEO of Biogen sometime within the next few months.

The Board and I recognize that this is an excellent time for a transition.

The Company is doing well now.

The management team is complete and extremely capable.

The commercial and R&D activities are going well, and we're on our way to adding to the pipeline through internal and external opportunities.

It's a good time for a new CEO to take the helm, and see Biogen through to what I believe is a very exciting future.

This also is an opportune time for me to return to the West Coast, take on one more set of activities, and spend more time with my family.

I've been at Biogen for six years.

I'm proud of the Company, and what we've been able to accomplish in that time.

We've introduced six new products onto the market, and increased our revenues, earnings, and stock price, all by several-fold.

And I believe that we're well positioned to keep delivering on our potential to bring even more therapies to patients, and returns to our investors.

Our R&D and commercial organizations are now world-class, joining our already industry-leading biologics manufacturing capabilities.

All aspects of the Company are operating at a high level.

We've brought several potentially game-changing compounds into later stage development, and are in the process of adding further to that pipeline.

With the addition of Michel Vounatsos, Mike Ehlers, and Paul McKenzie, the Company has a full and vibrant leadership team that's capable of moving the Company thoughtfully forward.

I truly believe that the Company has a bright future, and it's with mixed emotions that I leave at this time and not see that future come fully to fruition.

We're making the announcement now, in order to provide an orderly transition for the Company, and to allow the Board to conduct an open and effective search.

I'll work with the Board to find a great successor, who can continue to build on what we've accomplished.

We expect to consider both internal and external candidates, and I'm confident that we'll identify an outstanding new leader.

I expect to remain as CEO until a successor is identified and can begin.

In the interim, I'll continue to work with the Board and management team to accomplish Biogen's goals for 2016.

I believe that we're on a good trajectory, that we have great new additions to the management team, and I look forward to a successful second half of the year.

So, enough about me.

Let's turn to the Business.

Biogen had a solid second quarter, delivering strong financial performance, and important advances in our pipeline.

For the second quarter of 2016, Biogen generated $2.9 billion in total revenues, a 12% increase from the same period a year ago.

Our GAAP earnings were $4.79 per share, a 22% increase year over year, and non-GAAP EPS was $5.21, a 23% increase year over year.

We continue to grow our leading MS franchise and our hemophilia business, and our efforts to maximize revenues while thoughtfully managing expenses helped to drive attractive earnings growth.

As a result, we've raised our financial guidance for the full year.

And today we announced that our Board of Directors has authorized a program to repurchase up to $5 billion of our common stock.

Looking back, we had quite an eventful second quarter.

To begin, we welcomed three new members of our management team.

Our new Head of Commercial, Michel Vounatsos, joined us in April.

He's completed a thorough assessment, and has identified four key priorities for driving our MS business forward, which he'll share with you later in this call.

Our new Head of R&D, Mike Ehlers, joined us at the end of May.

Mike is a brilliant neuroscientist and an established R&D leader who has excelled in both academic and corporate settings.

Mike has demonstrated the ability to translate science into the development of important new medicines, and he's already bringing terrific leadership to the Organization.

And finally, with John Cox preparing to lead the new hemophilia company, we promoted Paul McKenzie to oversee our pharmaceutical operations and technology group.

These three new leaders bring a wealth of experience and expertise, and we believe that they're poised to take Biogen into its next phase of growth.

I'm proud to have them in our Organization.

Last quarter brought a number of positive developments for both our commercial products and our pipeline.

We announced our intent to spin off our hemophilia business.

That business continues to perform well, with combined second-quarter revenues of over $200 million for ELOCTATE and ALPROLIX.

ALPROLIX also was approved by the European Commission for the treatment of hemophilia B, and would be commercialized in the EU by our collaboration partner, Sobi.

We had a positive label update for TYSABRI in Europe, including an extended indication.

We received regulatory approval for ZINBRYTA in both the US and the EU for the treatment of relapsing MS.

FLIXABI, an infliximab biosimilar referencing Remicade, received approval in Europe.

This will be the second anti-TNF biosimilar that we'll manufacture and commercialize in the EU.

And SB5, an adalimumab biosimilar candidate referencing Humira, has been accepted for review by the European Medicines Agency.

Aducanumab was accepted into the European Medicines Agency's PRIority MEdicines program, known as PRIME.

It was one of only four applications accepted out of 18 submitted, and the only Alzheimer's disease therapy in development that was accepted.

On the early stage research front, we entered into a broad collaboration and alliance with the University of Pennsylvania and two world-renowned gene therapy experts, Drs.

James Wilson and Jean Bennett.

This quarter, we also reported the top-line results of the SYNERGY trial for opicinumab.

As you are all aware, opicinumab missed both the primary and secondary endpoints, which certainly was disappointing.

However, the rigorous design and planning of SYNERGY has yielded an abundance of data that will help us make a well-informed decision about our path forward with opicinumab, and our work in remyelination generally.

These results are indicative of the significant challenge of targeting neuro repair.

During the upcoming ECTRIMS conference in September, we expect to present more detailed efficacy, biomarker, and safety data.

I'll now turn the call over to Mike, and we're eager for you to get to know Mike and experience his passion for our Business.

Thank you, George, and good morning, everyone.

By way of introduction, I spent a number of years in academia as professor and Howard Hughes Medical Institute investigator at Duke University, where my research was focused on cell, biological, and circuit mechanisms of brain function, and the normal, developing, and diseased nervous system.

My career took an exciting turn six years ago when I joined Pfizer.

I served as the Chief Scientific Officer for the company's neuroscience and pain research unit, and ultimately became group leader for biotherapeutics R&D, with responsibility over rare disease, the centers for therapeutic innovation, and all large biomolecule sciences.

I am just now finishing my second month at Biogen, so there's still a lot I'm getting up to speed on.

But I can tell you from the outset that I am working to reshape and progress our pipeline, while aggressively pursuing promising assets, both internally and externally.

I plan to update you on progress on these fronts in the future.

In the meantime, I will comment on the important clinical study readouts this quarter, and note some good progress made in advancing our clinical programs.

Starting with opicinumab, or anti-LINGO, as George discussed, the top-line results from the Phase 2 SYNERGY study were reported, in which opicinumab unfortunately missed both the primary and secondary endpoints.

However, evidence of a clinical effect with a complex, unexpected dose response was observed.

The SYNERGY top-line efficacy, safety, and biomarker results will be presented at ECTRIMS in September.

Continuing in MS, EC approval was received for an extended indication for TYSABRI in highly active relapsing remitting MS patients with inadequate response to prior MS therapy.

TYSABRI was previously only indicated for patients who had failed to respond to beta-interferon or glatiramer acetate.

This label extension follows recent EC approval for a new patient management plan, including an updated risk algorithm based on JC virus antibody index values.

These changes will allow physicians to have more individualized benefit/risk discussions with their patients.

Turning to other promising late-stage assets, our collaboration partner, Ionis, continues to execute the Phase 3 studies of nusinersen for infants and children with spinal muscular atrophy, both of which are now fully enrolled.

In Alzheimer's disease, it was recently announced that aducanumab was one of only four applicants accepted in the European Medicine Agency's PRIority MEdicines program, or PRIME.

PRIME aims to bring treatments to patients faster, by enhancing the EMA's support for the development of investigational medicines for diseases without available treatment or in need of better treatment options.

We continue to work diligently to enroll our aducanumab Phase 3 trials.

Looking ahead, safety data from the titration arm of the Phase 1b study is anticipated by the end of this year.

We are working toward the start of Phase 3 trials for amiselimod, or MT-1303, in inflammatory bowel disease, and BIIB074, formerly known as raxatrigine, in trigeminal neuralgia.

An initiation of the Phase 2 trial with BIIB074 in patients with neuropathic pain from lumbosacral radiculopathy is planned for later this year.

In further activities, natalizumab's clinical profile and treatment window supports its continued investigation as a potential novel approach for treating acute ischemic stroke, and the first patient was recently dosed in a second Phase 2 study in stroke called ACTION 2.

Encouraging data was recently generated on earlier stage assets, BIIB059, our anti-BDCA2 for systemic lupus erythematosus, and BG00011, or STX-100, for idiopathic pulmonary fibrosis.

Anti-BDCA2 data in healthy volunteers, and a lupus cohort of 12 subjects, has provided confidence to move into Phase 2, with trial initiation planned to begin over this summer.

These data are anticipated to be presented later this year.

The BG00011 study is enrolling its final cohort, and it is expected that data will be presented after the trial completes.

Finally, as George mentioned, Biogen announced a broad collaboration and alliance with the University of Pennsylvania and Drs.

James Wilson and Jean Bennett, to advance gene therapy and gene editing technologies.

The expansive research and translational development collaboration has multiple objectives, and will primarily focus on the development of therapeutic approaches that target the eye, skeletal muscle, and the central nervous system.

Again, I am pleased to participate in my first earnings call here at Biogen.

I anticipate sharing more detail on the advancement of the Biogen pipeline in the coming months, as the Company works diligently to deliver new therapies to patients.

With that, I will now pass the call to my good colleague, Michel Vounatsos.

Thanks, Mike.

I'm very pleased to be with you this morning.

I'll share my initial thoughts on the MS market and our MS portfolio, outline my priorities going forward, and then I will discuss this quarter's results for MS products.

Since I arrived at Biogen three months ago, I have spent time in the field with our operations team, meeting with patients, the neurology community, and many of the scientific leaders in multiple sclerosis.

Also I have engaged with the strong Biogen leaders across our commercial organizations.

I have listened and learned a lot, and together with the team, we have prioritized immediate opportunities across four key areas.

We believe these opportunities will benefit our MS franchise today, and at the same time, prepare the Organization for potential future product launches.

Before speaking about our therapies, I think it is important to note MS is a growing market, with approximately 850,000 treated patients worldwide, out of a global prevalence estimated at 2.3 million, which includes progressive forms of MS. We estimate the number of treated patients worldwide is growing in the mid-single digits on an annual basis, driven by low single-digit growth in the US, and high single-digit growth in Europe.

The relatively higher market growth rate overseas is largely due to increasing rate of diagnosis and treatment.

And as a leader in MS, we believe we are well positioned to benefit from these trends over time.

Using the US as an example, where we have the most detailed data, we estimate that approximately three-quarters of the 300,000 treated patients are stable, and presumably satisfied on their current therapy.

We believe Biogen is holding a clear leadership position in the stable segment of the market.

We believe the dynamic opportunity of patients in the US is comprised of approximately 15,000 newly diagnosed patients, and approximately 60,000 patients changing medication each year.

We believe that Biogen also holds a leadership position in new patient starts within this dynamic portion of the market.

Turning to MS portfolio, we believe that the value of our products is well recognized in the eyes of many of our customers, as reflected in our leading global market share of approximately 38%.

We believe the breadth of our portfolio is, and will continue to be, a source of strength in the marketplace, by allowing physicians to prescribe the right drug, to the right patient, at the right time.

As the most prescribed oral therapy for MS worldwide, TECFIDERA benefits from a compelling combination of efficacy, convenience, and relative safety.

As a result, we estimate that TECFIDERA captures roughly 25% of newly diagnosed and switching patients.

Our market research indicates that TYSABRI is clearly viewed as differentiated in terms of efficacy, and retains an important role for patients with highly active disease, capturing roughly 30% of all patients switching for efficacy reasons.

Our interferon products, AVONEX and PLEGRIDY, combined, hold leading share amongst the interferon therapies, despite facing headwinds.

Due to the uptake of [orals], we believe these products will continue to play an important role going forward.

We are also preparing to launch ZINBRYTA next month in the US and Germany.

ZINBRYTA is the first in a new class of MS therapy.

We believe it will be used by patients switching for efficacy reasons, benefiting from once monthly at-home subcutaneous administration, and a differentiated mechanism of action.

Going forward, we will concentrate our work in the commercial organization across four key priorities, namely: portfolio strategy, commercial excellence, medical leadership, trust and value.

With portfolio strategy, we plan to further define our strategy for products, market segments, and geographies.

We will work to ensure that our targeted growth opportunities drive consistency across our resource allocation, messaging, marketing tactics, and salesforce execution.

Within commercial excellence, we will work to increase our sophistication in [multi]-channel marketing including enhancing our digital capabilities, while also strengthening our engagement with key customers at the local level.

While clearly perceived as a leader in neurology research and clinical development, we believe we also have an opportunity to further enhance our medical leadership.

This includes close collaboration with our medical field teams, and partnership with scientific leaders.

Finally, trust and value -- we will work towards developing innovative, beyond the [pill] solution for our customers to enhance our reputation, and strengthen our partnership and role as a leader in MS. I think that, as the leader in MS, we have this responsibility.

Today, we already have a well-defined plan outlining next steps and target dates, which we have started to implement across the Organization.

We are initiating this with the aim to accelerate our Business, to be more focused, to make conscious choices, and to be diligent in resource allocation.

We believe that this work will be beneficial for our Company and our shareholders.

For competitive reasons, I am not prepared to go more into the details of these four initiatives, but I look forward to updating you on our progress at future meetings.

Turning to the results for the quarter, total MS revenues were $2.2 billion this quarter, an increase of 9% versus Q2 of last year.

We believe our global market share continued to grow.

Starting with TECFIDERA, in the US we saw a modest increase in demand compared to the first quarter, largely due to a normalization of the seasonality typically seen early in the year.

All of our metrics lead us to expect a continued stable trend for TECFIDERA going forward.

Outside of the US, we continue to see increased adoption in the UK, Italy, Spain.

In fact, the number of TECFIDERA patients in Europe has increased approximately 40% over the last year.

PLEGRIDY is now available in roughly 20 markets in Europe, and where launched, we believe it is helping to slow the rate of decline of our interferons.

TYSABRI continued to add patients this quarter.

We recognize the potential for increased competition from other [high efficacy] therapies, but we believe TYSABRI's 10 years of post-marketing experience and well-understood safety profile position it very well.

In collaboration with AbbVie, we are actively preparing to launch ZINBRYTA starting next month.

We are particularly encouraged by the broad indication and data reinforcing the product safety included in the EU label.

We are also making progress in our biosimilar business this quarter.

We are seeing strong initial uptake for BENEPALI, the first biosimilar approved in the EU referencing Enbrel.

And we expect to launch FLIXABI, our biosimilar referencing Remicade, in the coming weeks.

While we only expect a modest contribution from biosimilars in 2016, we do believe this is an attractive opportunity in the longer term.

So, the team delivered a very solid quarter.

I look forward to taking Biogen into what I believe is an exciting future.

With that, I turn the call over to Paul.

Thanks, Michel.

In the second quarter, our GAAP diluted earnings per share were $4.79, a 22% increase year over year, while our non-GAAP diluted earnings per share were $5.21, an increase of 23%.

Total revenue for Q2 grew 12% year over year to approximately $2.9 billion.

It's important to note, we had $173 million in foreign exchange hedge gains in the full year of 2015, which impact our year-over-year revenue comparisons this year.

In Q2, versus prior year, revenues were unfavorably impacted by $45 million from hedging.

Combined with the $1 million benefit from foreign exchange rates, overall revenue was weakened by approximately $44 million year over year.

I'll highlight the impact of foreign exchange and hedging on each of our major MS therapies.

Global second-quarter TECFIDERA revenue was $987 million, an increase of 12% versus the same quarter last year.

This included revenues of $780 million in the US, and $206 million outside the US.

In the US, TECFIDERA modestly benefited from an inventory rebalancing in the wholesaler channel, versus prior quarter.

Outside the US, foreign exchange and hedge impact weakened TECFIDERA revenue comparison by approximately $13 million.

Interferon revenues including both AVONEX and PLEGRIDY were $728 million during the second quarter, an increase of 6% versus the same quarter last year.

This included $519 million in the US, and $209 million in sales outside the US.

In the US, AVONEX also modestly benefited from an inventory rebalancing in the wholesaler channel versus prior quarter.

Outside the US, foreign exchange and the hedge impact weakened interferon revenue comparison by approximately $17 million.

TYSABRI worldwide revenues were $497 million this quarter, an increase of 7% versus the same quarter last year.

This included $305 million in the US, and $192 million outside the US.

Foreign exchange and the hedge impact weakened TYSABRI revenue comparison by approximately $13 million.

Turning to our hemophilia business, which generated $205 million this quarter, ELOCTATE revenue for the quarter was $125 million and ALPROLIX revenue in Q2 was $80 million.

We continue to work towards spinning off our hemophilia business and related assets, and plan to file the Form 10 later this summer, and complete the distribution in early 2017.

Turning to our anti-CD20 revenues, we recorded $349 million for Q2, an increase from prior quarter, driven by solid demand.

Total other revenues, which include revenues from collaboration relationships, royalties, and contract manufacturing were $79 million.

Now turning to the expense lines on the P&L, Q2 GAAP cost of goods sold were $370 million or 13% of revenue.

Non-GAAP cost of goods sold were $354 million or 12% of revenue.

As a percentage of sales, COGS was impacted by increased inventory write-offs, versus the lows seen in prior quarter.

In addition, based on our valuation of our small-scale manufacturing capacity needs, we booked a GAAP-only charge for accelerated depreciation related to our intent to close or divest our small-scale manufacturing facility in Cambridge.

Q2 GAAP and non-GAAP R&D expense was $473 million or 16% of revenue, which includes $20 million related to the gene therapy collaboration with the University of Pennsylvania.

Overall, R&D reflects relatively low business development expense, though this remains a critical strategic priority for us, as we look to bring in high-quality assets.

Q2 GAAP SG&A was $492 million or 17% of revenue.

Q2 non-GAAP SG&A expense was $489 million, also 17% of revenue.

We remain committed to achieving savings by reducing lower priorities and services for the balance of the year.

Recall, over the last few years we've gone through a number of product launches, and thought it was the right decision to invest behind these products.

Starting in 2015, we pivoted, and took a number of actions to curb operating expense growth, including a restructuring, and further efforts to reduce costs, which is reflected in our operating leverage for the quarter.

This will also allow us to reinvest in the pipeline.

Other net expense was $59 million in Q2, which includes $66 million in interest expense related to our 2015 bond offering.

In Q2, both our GAAP and non-GAAP tax rates were approximately 25%.

Our weighted average diluted share count was approximately 219 million for Q2.

This brings us to our diluted earnings per share, which were $4.79 on a GAAP basis, and $5.21 on a non-GAAP basis for the second quarter.

We ended the quarter with approximately $7.3 billion in cash and marketable securities, with approximately 40% of this in the United States.

Today we also announced a $5 billion share repurchase program, which we anticipate will be executed over the course of the next three years.

We believe this leaves ample room for flexibility for strategic deployment.

So overall, we had a strong quarter, driven by revenue growth from our MS therapies rebounding from the seasonality seen in the first quarter, continued growth from our hemophilia business, and diligent cost controls.

This now brings us to our full-year 2016 guidance.

We now expect revenues of approximately $11.2 billion to $11.4 billion, a modest improvement from prior guidance.

Our outlook assumes continued, stable demand -- patient demand for TECFIDERA in 2016 in the United States.

We believe TYSABRI will also remain on a stable trajectory for the balance of the year.

Our outlook assumes AVONEX and PLEGRIDY patients combined will continue to gradually decline, as patients move toward orals.

For ZINBRYTA, we anticipate a modest revenue contribution in the US and EU, as launches are expected to begin in August.

And our revenues outlook is based on stable foreign exchange rates.

From an expense perspective, we anticipate upward pressure on cost of goods sold due to the unexpected issuance by the US Patent Office of a patent to a third party related to recombinant interferon beta protein.

This patent, issued on June 28 and expiring in June 2033, is relevant to AVONEX and PLEGRIDY.

We will pay royalties in the mid-single digits during the life of this patent.

For the remainder of 2016, we expect the royalty payment to be approximately $[50] million.

We anticipate GAAP and non-GAAP R&D expense between 17% and 18% of sales, and GAAP and non-GAAP SG&A expense to be between 16% and 17% of revenue.

We anticipate GAAP EPS results between $18.10 and $18.40, and non-GAAP EPS to be between $19.70 and $20.

Our outlook assumes a very modest reduction in our full-year weighted average diluted share count.

Of note, this guidance assumes contribution from our hemophilia business through the balance of the year, as we expect the spinoff to complete in early 2017.

Additionally, this guidance does not include any impact from potential acquisitions, or large late-stage business development transactions, as both are hard to predict.

Overall, this increase in guidance reflects the solid revenue seen this quarter, combined with the continued operating expense control.

I'll turn the call over to George for his closing comments.

Okay.

Thank you, Paul.

Financially, I'm pleased with where we are so far this year.

Our results year to date have been better than expected.

We've raised guidance, and we have a new share repurchase program authorized by the Board.

We've made good progress towards the three focus areas I discussed after the first quarter -- careful management of expenses, maximizing revenues, and rapidly advancing the pipeline.

As I look forward and think about the future growth of Biogen, I want to stress how those key focus areas will evolve.

The team expects to continue managing expenses.

But as you know, we can't save our way to growth.

Maximizing revenues and rapidly advancing the pipeline will become front and center, especially with Michel and Mike now in their respective roles.

Michel's four key priorities of portfolio strategy, commercial excellence, medical leadership, and trust and value will be the pillars we use to maximize revenues.

And under Mike's leadership, we intend to reshape the pipeline, rationalize existing programs, and aggressively pursue promising assets, both internally and externally.

We believe this focus will help advance more assets through the pipeline, and ideally deliver more therapies to patients.

At the same time, as we're bringing focus and investment to our core area of expertise in neurology, we'll continue to be opportunistic when we see internal and external opportunities to enhance shareholder value.

As a result, we've progressed some of the most promising earlier stage assets that we have in our pipeline, even outside of neurology.

We've invested in our biosimilar joint venture to leverage our competitive strengths in manufacturing and commercialization.

We've chosen to spin off our growing hemophilia business, because we believe it's the right decision to ensure fit and focus.

And as we've announced today, we'll buy back shares when appropriate.

So we've delivered strong financial results this quarter, while making progress advancing our pipeline and our commercial business.

We have a great leadership team, and a passionate group of employees who come to work every day to make a positive impact on patients' lives.

It's been an honor and a privilege to serve this Organization as the CEO for the last six years, and I remain committed to leading the Company until my successor is identified.

I want to take this opportunity to thank all of our employees for their hard work and dedication, and I want to thank you all for joining us this morning.

And, operator, we'll now open up the call for questions.

(Operator Instructions)

Your first question comes from the line of Mark Schoenebaum from Evercore ISI.

Please go ahead.

Hey, guys.

Just wanted, George, I wanted to say -- just, the stock only quintupled under your leadership.

So was wondering if you could, I think you should be held accountable for that.

(laughter) So was wondering if you could address that?

So congratulations, you will be missed.

Thanks for the honesty, transparency that you brought to Biogen over the years.

And I'd like to know who your least favorite sell-side analyst is, please?

(laughter) Or not, assure me, that it's not me?

It's definitely not you.

Okay, got it.

Especially after that last comment.

Okay, very good.

And Paul, could you (multiple speakers)

You've moved up from the bottom, Mark.

Patriots still suck (laughter).

My question is -- this has been asked before, but I just want to engage you guys in a little bit of discussion.

Why not release efficacy data from the titration cohort of the [Amab] trial, given that -- I know it's small numbers, but the numbers aren't that much smaller than the individual dose arms we've already seen.

And the follow-up is just, can you just update us with any specifics on enrollment?

Is enrollment tracking within your expectations?

And can you just remind us at this point when you'd expect data readouts, and if there are interims?

Thanks.

Hello, Mark.

This is Al.

So yes, it makes sense that the number of patients is roughly the same.

Our plan is to introduce the safety data, the tolerability data from the titration but -- and efficacy is an exploratory endpoint.

I'm sure at some scientific meeting, we'll be able to disclose that for completeness' sake.

And in terms of enrollment, we're not really commenting on it, except to say that we're pleased, and that things are on track.

And we hope to update you more on that in the future.

You next question comes from the line of Brian Abrahams from Jefferies.

Please go ahead.

Thanks very much for taking my question.

And Mike, congrats to George, as well on all your accomplishments, and best of luck in the future.

A question on the business development front: as you talk about aggressively reshaping the pipeline and pursuing promising assets, I'm curious your latest thinking, in terms of stage of development, size of the potential deals, the types of assets therapeutically that you might focus on?

How are you thinking these days about balancing maintenance of focus on neurology, versus further diversifying the business?

And how does the CEO transition potentially affect all these goals?

Thanks.

Yes, first, well, let me take that last point, first.

I don't think the CEO transition affects these goals at all.

The Company is committed to bolstering the pipeline, and we're working aggressively to do that.

And [actually], we would look at deals at all stages of development, from preclinical through Phase 3, and we are currently doing that.

We're in a number of discussions now, and we hope to bring some of those to a conclusion.

We are focused largely on neurology.

That's where we have our core expertise.

And I think we believe that you can make more sophisticated decisions about things in areas that you understand really in detail.

So mainly, we're looking in neurology.

With Mike's arrival, we have a new person here who's got his own set of expertise, his own views on things.

And I would say, we wouldn't rule out things outside of neurology, but the bar gets higher, as they get further from our center of excellence.

As Mike put it yesterday, we want to have laser vision, but we don't want to have tunnel vision.

And we want to be open to things that are interesting, and could provide shareholder value.

Your next question comes from the line of Geoffrey Porges from Leerink Partners.

Please go ahead.

Thank you very much for taking the question.

George, we're not sure what's so special about California, but all the very best of luck with your next chapter.

And thanks again for all the information you've shared with us, and for the success you've had at Biogen.

Thank you, Geoff.

I would say, if you're not sure what's special about it, you haven't been there (laughter).

So one question -- a couple questions for Michel, actually.

Michel, could you give us a sense of what your contributions from price and volume were on the MS franchise during the quarter on the US side?

And then, what your price contribution, or price effect was on the ex-US side?

And then, could you secondly add -- as you look at the MS franchise, presumably you will have no role in ocrelizumab's commercialization, but nevertheless they're your partner.

Could you give us your view of how you see that playing out, in terms of the effect that drug might have in the MS market, and on the outlook for Biogen's own products?

Thanks.

Thanks for the question.

And let me start with ocre, and Paul will comment on the other part of the question.

First, I would like to say that we are very pleased, and we applaud any new innovation in MS, for which we have contributed, we contribute, and we continue to invest in our pipe.

So this is a great news for patients in need [to address] gaps in therapy.

And I think this is a great news, and Roche's results on the PPMS is even more encouraging.

So we are very happy about that.

Having said that, we have a strong presence in the high-efficacy segment of the market.

And this is basically a market trend, where we can see that basically providers are treating earlier, and physicians are treating earlier, more aggressively.

And TYSABRI held, is holding a very strong position in the high-efficacy segment.

And ZINBRYTA, we come, and we complement this presence there.

So I anticipate that ocre will be playing into this segment also, and we will see how it plays.

But for the time being, there is no risk/benefit assessment, so we have to be very cautious before talking.

So I will wait to see where regulators stand.

But I will say, that the first approach from, again, a humble but leadership position is to take care of our assets, and elevate the capability of the organization.

And the four capabilities that we are launching will just do that.

Jeff, this is Paul on the price versus volume question.

I think the way you framed it, is probably pretty accurate, is that it's a tale of two cities.

In the United States, the lion's share from a change year-over-year basis is price, and is pretty stable unit trends on TECFIDERA; pretty stable unit trends on TYSABRI, and modest gradual decline on the interferon franchise.

Ex United States, we are not seeing any pricing on a year-over-year basis, and all of the gains are attributable to volume and unit expansion.

TYSABRI is holding well outside the United States, as well as the interferon business.

And we continue in a small way penetrate some markets, and get some accretive benefits of things, even outside of Europe.

In TECFIDERA, continues to expand on a year-over-year basis, and gaining market share, particularly as we are moving into relatively early launch timing in Southern European countries, and having very good success in the UK.

Your next question comes from the line of Eric Schmidt from Cowen and Company.

Please go ahead.

Thanks for taking the question, and congrats, George.

Good to see you leave on a high note.

Best of luck with the next opportunity.

Maybe just a quick one for Paul on this new interferon patent that you pay out a royalty on -- or expect to pay a royalty on.

Can you clarify a little bit who's patent that is?

And what happened to your own interferon patent that you thought was, at one point, going to be able to extract royalties from others?

Yes, great question, Eric, thanks.

It was, as I noted, unexpected, that it is not actually related; despite it is on the recombinant interferon beta protein, it's not actually the same.

It has to do with JFCR.

In the Q this afternoon, we'll actually have the patent number for you.

I actually, just actually don't have it handy for myself, and it's a mid single-digit royalty.

We aren't disclosing the name of the third party, but so just the third party at this point in time.

And we expect it will be a $50 million impact all in the second half, effectively, and will be a bigger impact as we go into 2017 on a full-year basis.

The 755 patent -- we continue to feel like that -- despite it was like back to 2009 when it was issued.

But we still to feel, and we're still in litigation with other parties on that.

But there's a chance that we're coming towards the end of that process for something favorable.

Your next question comes from the line of Geoff Meacham from Barclays.

Please go ahead.

Morning, guys.

Thanks for the question.

George, I also want to offer my congrats.

You will be missed.

So I had a question for Michel, maybe a bigger picture commercial question.

Now that you've had a chance to look at the products, the assets at Biogen, and a fresh look at the MS market, maybe just give us some perspective on what you see as the bigger growth opportunities ahead on a volume basis?

Is it geographic, is it rest of world opportunities, is it new product launches?

And then, maybe for Paul, just wanted to check and see what you guys learned from the DTC campaign for TEC and the sustainability of that?

Thanks.

Thank you for the great question.

In my 25 years experience around the world, I have never seen such a situation, whereby we have five or six assets in the same therapy area; the 20 years of those [solid unique] I would say experience in MS; a solid portfolio today; a solid pipeline; a remarkable group of talents of with clinical experience and scientific experience within the Company.

So it's a leadership position on interferons, a leadership position on orals, a leadership position on high efficacy, their products.

So this is a remarkable situation.

And on top of that, we are launching ZINBRYTA.

So the dynamic is very good.

Having said that, when you peel the onion, and get to discover your opportunity and the operations, you find ways to do better.

And this is why together with the team, we have prioritized four key areas: portfolio management, five, six assets in the same therapy area.

It's a challenge on how to manage that well: commercial excellence, medical leadership, trust and value.

And I believe with those, we will be able to make sort of difference.

And geographically also, we can see that some parts are better managed than others, and I have already started to make some decisions.

We don't wait, and you can expect that more will come.

So this is what I would like to say -- and the portfolio management doesn't mean that all the products will be resourced and promoted equally.

It's all about the growth opportunity, the way that you outline.

And this is where there will be a clear, I would say, alignment between those resource allocation and execution.

Geoff, the beginning part of your question is, yes, just to confirm, we have sunsetted the television campaign as it relates to TECFIDERA.

I think our -- I mean, look, it was a innovative -- I'd applaud our organization for thinking about it, and giving it a try.

I think that our judgment at this point is that it didn't have a discernible movement on scripts.

And potentially came -- this is more, is much from anecdotal, with some drawbacks as well.

Michel actually confirmed from his perspective, that there quite possibly is much other levers that are still like DTC-related, and multi-channel related that we can reallocate resources toward.

So I think that's probably our learnings in a nutshell.

We didn't run the test case.

So we'll see what the -- but I think that's our learnings.

Thank you, Paul.

Hi, this is Michel, if I can add.

I mean, at the outset, and I was not here -- the main objective was increased awareness, and I think that this was achieved.

But I didn't see any inflection on any trends.

We need to circle back to the alignment of the organization on four priorities, for which we need to have some very strict resource allocation decisions.

And I don't think that broadcast TV will be there in the foreseeable future.

Your next question comes from the line of Cory Kasimov from JPMorgan.

Please go ahead.

Hi, this is Whitney on for Corey.

I'll add my congrats to George as well.

I guess, just to circle back on Alzheimer's -- where are you with combinations?

And what's the desire or urgency to get some of the combos into the clinics, before you maybe have Phase 3 data on any of the individual components?

This is Al, Whitney.

And we like the idea of combinations.

I think one day we will be using combination therapies for Alzheimer's disease.

One of the reasons why we brought in a base inhibitor into our pipeline with our collaboration with Bayside, the reason we have tau programs internally, and that we are in search of even other things potentially to add to the mix, is based on in part on that belief, that combination could be helpful.

And you can think of it in two ways.

One is to combine two drugs, each of which are active to increase the efficacy overall; or to reduce the dose of two active therapies, so that you get better safety or tolerability for the same efficacy.

And also there may be sequential treatments where you start early, perhaps even before symptoms with one type of medicine, and then treat with something else when you have a high plaque burden, and then something else still when tau starts to progress.

When you start to think about combination therapy though, it's often difficult to do the right studies, without some evidence of efficacy of each drug as monotherapy.

And then you can start to think about the right dosing regimen.

And so, I hope that's helpful.

Your next question comes from the line of Michael Yee from RBC Capital Markets.

Please go ahead.

Hey, thanks.

Good morning.

My appreciation to George as well.

Happy to see you joining me on the West Coast.

I'm lonely out here, so happy to have you back here.

Hey, a question for Al.

There will be LINGO data presented at ECTRIMS.

Can you maybe just revisit this briefly, and give us some color about what is going on here in terms of what we saw?

Because obviously that was a surprise.

And is there anything specific that we should pay attention to at ECTRIMS that you've done work that would pique our interest back here?

Or is there some issue here with the remyelination pathway, and that would bring our questions into your oral?

So how does this change our thinking about remyelination, and what we saw here?

Thanks.

Yes, Michael, thanks for the question.

So first I want to say, this is a really large and rich data set, really the first of its kind -- not only in MS, but to my knowledge in neurology, where we're in the early stages of figuring out how to repair the brain, and how to measure measurements, outcome measures of repair.

The things we're focusing on right now when we look at this rich data set are: what are the right cohort of patients to treat?

In this trial we've looked at relapsing MS patients as all the way to secondary progressive; so it's a wide range of patients.

What's the right -- what's the optimal cohort?

What's the right dose?

We studied four different doses, and we saw a complex dose response curve.

What we actually saw was sort of a bell-shaped curve, where we lost efficacy at the highest dose.

And in the middle doses, we think we see a signal of efficacy.

And so, we'll share some of that ECTRIMS.

What's the right concombinant medicine to use?

We envision that these repair therapies will be added to immunomodulators.

And so, we'll be looking at that.

And in particular, whether ongoing inflammation in the brain impedes repair?

And finally, how do we actually measure the effects of repair, if it occurs, particularly on clinical outcome measures?

So some of these questions will be answered by doing further analyses, which we're in the middle of doing right now intensively.

And we'll share whatever we find out at ECTRIMS, and some may need another study.

And so what we're honing in on is, what's the next step, what's the next study?

And obviously, this will be a judicious investment.

If we can go to Phase 3, we would try.

I don't know, until I see the specific design.

It could be a Phase 2, could be a Phase 3, could be a Phase 2/3.

And that part, we probably won't be able to share at ECTRIMS, but sometime soon, we hope to be able to share that.

Your next question comes from the line of Robyn Karnauskas from Citigroup.

Please go ahead.

Thanks for taking the question.

I guess, George, I remember meeting you when you first became the CEO.

And I remember you talking about (inaudible) the Company, and what your pipeline [was so well needed] at the time, it really changed size.

And so, then now, I think the Company is a different company, and there's been pipeline success, and there has been failures.

What do you think Biogen really needs from a new CEO at this point in time, versus when you came in?

Well, look, the Company, now is very different company from what it was a few years ago.

We have a full and excellent management team.

We have a pipeline that is, I think, quite exciting, but needs to be -- to grow.

So I think the Company needs good management.

I think the strategy of the Company is solid.

And what we need is good leadership, and somebody who can work with the people who are here, work with Michel, to maximize the commercial potential, work with Mike, [rationalize] the potential of our pipeline, grow the pipeline.

And can work with the rest of the organization, to ensure that we go forward in a way that is responsible, where we minimize expenses, but that where we invest aggressively in those areas that really have the potential to add value.

So being CEO is complicated, and I think those are the priorities I would set.

Of course, the search will be conducted by the Board, but I don't think they would view it too differently.

I think there will be a continued focus on innovation, and I'm confident we'll get someone excellent.

Your next question comes from the line of Ronny Gal from Bernstein.

Please go ahead.

Good morning, and thank you for taking my questions.

Two questions.

First, biosimilars -- you had a pretty good first quarter.

Can you describe a little bit to us where you've launched already, where you are still expecting to launch?

And now that you've had a little bit -- what it is, [as you see] in that market, can you just give us a feel for your thinking about the three to five year trajectory for this franchise, and for biosimilar, for anti-TNF?

And Europe in general, should this be 30% of the market, 50%, 70% of the market overall?

And then separately, you mentioned the impact of high deductible co-pays on the US sales in the first quarter.

Has there been still some impact to those in the second quarter -- that is, as we look from the outside of revenue, should we see another step up in revenue per unit in the third quarter?

Or is it being fully incorporated in the first quarter, and kind of the runway for pricing in the second quarter, is roughly what we should see going forward?

So this is Michel.

Thanks for the great question.

So as you have seen, two great companies came together with complementary capabilities, in order to launch anti-TNFs, to get started with.

And then, we see what is the go-foward opportunities.

And so, as our aspirations involved together with the partners, we have launched the products, the three anti-TNFs that for which we have the agreement on, two out of the three are approved, and are on their way to be launched The preliminary results are very encouraging.

As you can imagine, there is a tremendous level of variation and [variability] between countries, in terms of tendering, in terms of aggressitivity of the competition, in terms of provider decisions, basically.

And it's difficult to take an overall, I would say, recipe on how to best launch.

What I can say is that, the three anti-TNFs that we'll have the opportunity to launch, we'll be addressing a current market that is higher than $9 billion in Europe.

So this is significant, and with Biogen quality.

So we've put together a standalone [BU] that is flexible, agile, in order to launch this product, and we learn country after country.

Today mostly, in the Nordics and Scandinavia, where we have had very good results.

But as I said earlier, it's still early to comment much on the results that are negligible for 2016, but it will be more important moving forward.

Ronny, this is Paul.

Thanks for the second part of that question.

It's a good catch.

I think the answer is that we absolutely saw insurance dynamics mostly impact AVONEX in the first quarter, and we're pleased to see that choppiness settled out, and benefited the second quarter results.

Don't expect it to be meaningful, different for the balance of the year now.

And your final question comes from the line of Chris Raymond from Raymond James.

Please go ahead.

Hey, thanks for squeezing me in, and congrats, George, from us as well.

Just a question on TECFIDERA.

In the context of -- I think you highlighted in Q1, a $20 million inventory drawdown.

Could you maybe quantify -- I think you highlighted generally there was in inventory effect in Q2.

Could you quantify what that was?

And then also if I can, on TECFIDERA continuing -- I hear what you're saying on the television ads.

But one of the things that has struck us the most with our checks is, TECFIDERA for some time has been far and away the most requested disease-modifying therapy among patients.

I'm wondering, what additional levers can you pull to increase that?

Or is there some other aspect, like maybe working at better efficiency programs to get that request converted into a script?

Is there some other aspect besides just getting patients to request the drug?

Yes, thanks, Chris.

Paul, I will take the first part.

It's quite simply, I think we are at a pretty normal inventory levels on TECFIDERA.

So it was really just a sequential quarter, rebalancing off of the seasonal low that we generally see in Q1.

So on the levers and the performance.

12% growth Q over Q is not bad.

The share continues to grow to 15% globally, is also pretty good, mostly driven by the newly launched markets in Europe.

40% patients growth percentage is also a very encouraging.

I have from, my field visits, and from talking to leaders, identified one major issue, which is the discontinuation due to GI safety.

Those patients, during the first phase on the products, are suffering -- for some of them, on abdominal pain, diarrhea, discomfort -- that is leading in some cases, with a very high level of variability to discontinue on the product.

And this impacts, not only the outflow, but eventually the inflow.

The variability is tremendous.

I was in the field lately.

And on the Eastern coast in the US, 1.5% of the patient discontinued at six months, in some others, it was 30%.

So with Mike Ellis, we are fully aligned, in order to work together with the community, with the physicians, with the peer-to-peer, in order to best assess, best educate, and bring down an average which is at 20% today, to lower levels.

Okay.

With that, I thank you all for joining us this morning.

Thanks for the questions, and we'll sign off now.

Thank you, everyone.

This concludes today's conference call.

You may now disconnect.