Biogen Inc (BIIB) 2009 Q2 法說會逐字稿

Good morning, my name is Celeste, and I will be your conference operator today.

At this time I would like to welcome everyone to the Biogen Idec second-quarter 2009 earnings conference call.

All lines have been placed on mute to prevent any background noise.

After the speakers' remarks there will be a question and answer session.

(Operator instructions).

Thank you.

Mr.

Hoffman, you may now begin your conference.

Thank you, Celeste, and welcome to Biogen Idec's second quarter 2009 earnings conference call.

Before I begin, I encourage everyone to go to investor relations website to find the press release and related financial tables, including a reconciliation of the non-GAAP financial measures that we will discuss today.

We have also posted slides on our website that outline the topics discussed on today's call.

As usual, I'll start with the safe harbor statement.

Comments made in this conference call include forward-looking statements about our expected future results, including our 2009 financial guidance, our longer-term operational financial goals, the sales potential of TYSABRI and other products and pipeline advancements.

These statements are subject to risks and uncertainties, which could cause actual results to differ materially from expectations.

You should carefully review the risks and uncertainties that are described in our earnings release and in Item 1-A of our most recent annual and quarterly reports filed with the SEC.

We do not undertake any obligation to publicly update any forward-looking statements.

Today on the call, I'm joined by Jim Mullen, CEO of Biogen Idec; Dr.

Al Sandrock, SVP Neurology, R&D; Bob Hamm, Chief Operating Officer; and Paul Clancy, CEO and Executive Vice President of Finance.

With that, I'll turn the call over to Jim Mullen.

Thank you, Eric, good morning.

Very pleased to be able to report a successful quarter.

Not only was our financial performance strong, but we also made significant progress on a number of strategic fronts.

Total revenue grew 10% year-over-year to $1.1 billion, and product revenues were up 16% year-over-year.

Non-GAAP EPS for the second quarter of 2009 was $0.75, and this includes a $0.32 impact attributable to the $110 million upfront payment Acorda.

Our pipeline is progressing both organically and through business development.

Within the last month we dosed our first patient in the PEGylated interferon Phase III trial, reached a data readout and discontinued CDP323 Phase II study and in-licensed the ex-US rights to Fampridine-SR from Acorda Therapeutics.

Our marketed products posted strong business performance in the second quarter.

AVONEX revenue continues to grow with revenues up 12% year-over-year, its success driven by the long-term safety and efficacy profile.

TYSABRI patient growth has accelerated.

More than 3300 net new patients were added in Q2 for a total of 43,300 patients on therapy.

We believe that our marketing and sales efforts focused on the compelling efficacy started to take hold with physicians in Q1 and translated to accelerated patient growth in Q2.

We achieved TYSABRI global in-market net sales in the quarter of more than $250 million, which puts us on a blockbuster $1 billion run rate.

And, revenue from the RITUXAN unconsolidated joint business was $276 million on net US sales of $696 million.

Chief Operating Officer Bob Hamm will take you through an update of the commercial franchises.

Strategically, our pipeline is focused on first-in-class or best-in-class specialty products and diseases with high unmet need and global applications.

I'll provide a couple examples of recent progress.

In the PEGylated interferon program we made significant progress on this program for relapsing multiple sclerosis.

We enrolled our first patients in our Phase III ADVANCE trial in June, and the program was granted fast-track status by the FDA recently.

On the Acorda licensing agreement, we were very happy to announce on July 1 an exclusive collaboration and license agreement with Acorda to develop and commercialize Fampridine-SR in the markets outside the US.

We are excited by the potential benefits this functional modifier can bring to MS patients.

Al Sandrock, who leads the neurology and R&D organization, will give you an update on a number of the pipeline programs.

We're also pleased to have a resolution during the quarter of our arbitration with Genentech over decision-making rights for the CD20 franchise.

The arbitration panel issued a decision in June and reaffirmed Biogen Idec's contractual right to fully participate in strategic decisions regarding the development of RITUXAN and other anti-CD20 antibodies.

Finally, with respect to performance, our goal for 2007 to 2010 is to deliver 15% top-line and 20% non-GAAP bottom-line compounded annual growth rate.

With six strong quarters in the book, we are on track to achieve these financial goals.

We are updating our 2009 non-GAAP earnings per share to be above $3.85, and we continue to expect cash flow to exceed earnings.

The new guidance includes the impact of the $110 million up-front payment to Acorda, which will have a $0.38 impact for the full year 2009.

CFO Paul Clancy will give you additional financial details.

In conclusion, the second quarter was a successful one and we are updating our full-year 2009 guidance.

Our main focus was reaccelerating TYSABRI patient growth in the quarter, and we accomplished that goal.

We have strong franchises, cash flow and balance sheet, ending the quarter with approximately $2.7 billion in cash and marketable securities.

We continue to focus on products, pipeline and performance as drivers of long-term shareholder value creation.

I will now hand the call over to Dr.

Al Sandrock, Senior Vice President, Neurology R&D.

Al?

Thank you, Jim.

Today I'll be providing a number of updates on our pipeline with an emphasis on neurology.

Before we get to neurology, I want to provide a brief update on our ADENTRI program, which was recently assigned the generic name Tonapofyline.

Based on discussions internally and with external experts, and following Merck's results with Rolofylline, we have decided to revise the TRIDENT-1 trial of Tonapofyline [is in] acute decompensated heart failure patients with renal insufficiency from a Phase III study to a Phase II study.

The size of the study will be reduced accordingly, and data from this placebo-controlled multi-center trial are now expected in the first half of 2010.

This new approach will provide us high-quality data to inform the doses, patient population and endpoints of future clinical trials as well as reduce the investment risk, given the failure of a similar compound.

Most importantly, we expect this will have limited impact on our approval time line.

Now I'll spend the rest of my time updating you on our MS programs.

As we have said in the past, our goal with MS is simple but powerful -- slow, stop and eventually reverse the disease.

With AVONEX, we have made major progress on slowing the disease.

At the recent AAN meeting we presented the CHAMPION 10-year extension study.

In this study we follow patients on AVONEX for a decade after initiating therapy at the first clinical event suggestive of multiple sclerosis.

These patients continue to have a significantly lower probability of experiencing a second attack versus those patients with delayed treatment.

The data show that, of the patients taking AVONEX, 80% remain below an EDSS score of three, meaning they remain fully ambulatory with moderate disability.

These data show that starting AVONEX treatments shortly after symptom onset may translate into an ability to remain active and enjoy daily activities that otherwise might be lost without early treatment.

Turning to TYSABRI, it's been about three years since TYSABRI was reintroduced in the United States and launched internationally, and we have learned a great deal in that time about both the efficacy and safety of TYSABRI.

Based on the growing body of unprecedented efficacy data, we believe that TYSABRI goes a long way towards stopping disease activity in relapsing MS patients.

In February, we and our collaborators published in the Lancet Neurology that after two years of therapy, 37% of TYSABRI-treated patients remained free of disease activity compared to 7% of placebo-treated patients.

For these patients, disease-free meant no relapses, no sustained disability progression and no MRI evidence of disease activity, a significant advancement over the ABCR therapies.

More recently, as presented at the AAN meeting, a post-hoc analysis of the two-year AFFIRM pivotal trial showed that a substantial proportion of patients on TYSABRI treatment experienced sustained improvement of physical disability.

In addition, data from an ongoing one-year longitudinal health outcome study demonstrated overall improvement from baseline in cognitive functioning, fatigue and quality of life in as early as three months.

No other drug for the treatment of relapsing MS has demonstrated efficacy across such a broad range of outcome measures.

With respect to safety, we are of course aware of the recent speculations on TYSABRI's safety, including external analyses linking PML risk to therapy duration or to geography, preliminary case reports of adverse events and various single-center studies.

However, I would caution that it can be misleading to draw conclusions from isolated snapshots of limited data.

For example, had one drawn conclusions after the first four post-marketing cases, one might have determined that males have a higher risk.

I point this out only to caution against premature conclusions based on limited data.

It is important to note that TYSABRI is one of the most intensively monitored drugs on the market today.

You will recall that there are three main components of our risk management plan.

First, every single US patient is enrolled in the TOUCH registry to monitor for PML.

Outside the US there are a number of patient registries in major European countries.

As such, we believe we have complete ascertainment of PML cases worldwide.

Second, we have more than 5600 patients enrolled in our [TIGRIS] study, a five-year global observational study powered to detect rare and unexpected safety signals.

Lastly, we have more than 1000 patients enrolled in the STRATA long-term extension study, where we were collecting longitudinal data such as JCV load in the plasma, peripheral blood lymphocytes and urine.

Based on the wealth of information we have to date, the incidence of PML remains well within the rate indicated by the TYSABRI label, and it is too soon to come to any conclusions about specific risk factors.

We are nearly one year removed from the initial post-marketing cases of PML reported with TYSABRI.

As you know, there have been 10 confirmed cases with TYSABRI monotherapy since July 2006 out of a total of 56,500 patients treated.

Nine of the 10 patients remain alive with varying levels of disability.

While not all of them are where we'd like them to be, the range of outcomes appears to be better than estimated at the time the drug was unanimously recommended for approval by the FDA advisory committee more than three years ago.

With clinical vigilance and intervention, we have learned that PML can be detected early and may in fact be survivable.

Since the withdrawal in February of 2005, we have made every effort to learn all we can about PML, in particular to look for risk factors, to develop ways to mitigate the risk and to improve outcomes, should PML occur.

Early on, these efforts were focused on early diagnosis and treatments for PML.

We now have a validated, sensitive and standardized commercial assay to enable the accurate diagnosis of PML.

We were able to provide guidance to physicians on the use of plasma exchange to rapidly remove the effects of TYSABRI in the event of PML, and this may have improved the clinical outcome in our post-marketing cases.

We also identified Mefloquine as a potential treatment for PML and are conducting a clinical trial to test its effectiveness.

Of late, the team has turned its attention to identifying risk factors and risk mitigation strategies.

The premise behind these efforts is that PML results from a convergence of factors including the presence of JC virus in sights of latency, immune compromise, viral mutations and perhaps risk alleles in the host.

With respect to the prevalence of virus, the old textbook notion that JC virus is present in 80% or 90% of humans has been refuted by the preponderance of recent data in larger US and European cohorts using modern serological techniques that indicate that the seroprevalence is actually closer to 50%.

Should we be able to identify specific risk factors, we plan to provide the appropriate information to physicians which will enable them to make the right treatment decisions for their patients.

Moreover, we have reached out to other companies in our industry that have products associated with PML, and we are pooling our resources in a consortium to accelerate efforts to understand and develop mitigation strategies for PML.

Given the significant impact TYSABRI has on the lives of patients with relapsing MS, we are committed to learning as much as we can about the risk of PML and developing strategies and tactics so that the drug can be used in the most appropriate way for the most appropriate patients.

Now a word about communication.

Our communication of the TYSABRI benefit risk profile has long been led by the needs of clinicians and their MS patients, and we will continue to provide the MS community with timely information important to making critical decisions in a responsible manner.

As I stated previously, this is an intensively monitored drug, and we continue to have discussions with regulators on an ongoing basis.

I know I have spent a lot of time talking about safety, but it is important to put that in the context of the benefit TYSABRI brings to patients with relapsing MS.

Every day we hear from physicians and patients about how TYSABRI has made a significant positive impact on their lives.

They are, in fact, corroborating the benefit that we have observed in our clinical trials on a wide array of measures of efficacy and quality of life.

This drug was approved because it offers hope for many patients with this devastating disease.

Now a few words about the progress we've made in our MS pipeline.

We enrolled our first patient in our Phase III ADVANCE trial of PEGylated interferon last month, and the program was recently granted fast-track status by the FDA.

We expect to complete enrollment in our second Phase III trial of BG-12 later this year, and our daclizumab and anti-CD20 programs remain on track.

We and our partner UCB recently announced that a Phase II study of the oral alpha4 integrin antagonist CDP323 in relapsing MS was terminated following a preliminary interim analysis.

And, finally, we are preparing to file an IND on anti-LINGO at around the end of the year.

The anti-LINGO antibody has been shown to remyelinate nerve fibers in our animal studies and thus promises to reverse some of the damage done by diseases like MS.

Lastly, I'll also mention the newest and very exciting addition to our MS portfolio, Fampridine-SR.

This oral small molecule is a first-in-class selective blocker of voltage-gated potassium channels, which is thought to improve nerve conduction in demyelinated nerve fibers.

Fampridine-SR has completed two successful Phase III clinical trials under special protocol assessments, and these trials have demonstrated improved walking ability in patients with multiple sclerosis.

Mobility is a critical issue for many MS patients, and we believe that this novel functional modifier can provide clinically meaningful benefit for many patients.

Biogen Idec is responsible for ex-US regulatory filings and are planning a submission to the EMEA in the first half of 2010.

So, again, it is our goal to slow, stop and reverse MS.

We are making progress and we look forward to continuing to update you on our progress in the quarters ahead.

With that I'll hand it over to our Chief Operating Officer, Bob Hamm.

Thanks, Al.

During the second quarter our global revenue was $1.093 billion, up 10% year-over-year.

Second-quarter RITUXAN US net sales were up 7% year-over-year to $696 million.

RITUXAN revenues on our P&L were $276 million, down 1% year-over-year, driven by 12% growth in quarter two US profit share, offset by a 29% decline in our international RITUXAN revenues as our ex-US royalties began to expire.

Our product revenues of $791 million grew nearly 16% year-over-year, fueled primarily by new 10-year data on early use of AVONEX and re-accelerating TYSABRI patient growth.

Q2 marked our first quarter of TYSABRI sales over $250 million, a blockbuster run rate.

RITUXAN -- our solid RITUXAN sales performance has been driven by continued adoption in the NHL post-induction setting, as well as inroads as a second-line biologic in RA.

We believe that our recent marketing efforts updating RITUXAN's safety profile with over six years of clinical experience totaling more than 5000 patient years have supported physicians' increasing use of RITUXAN in RA.

Our marketing efforts emphasizing lasting efficacy with RITUXAN have started to take hold as well.

On the regulatory front, we supplemented our DMARD IR sBLA filing with some additional data from the recent IMAGE study, and our current PDUFA date is now in October.

In addition, we and our partners filed CLL data in May from both the CLL-8 and the REACH studies.

Moving to the neurology business, AVONEX's $591 million in global revenue for Q2 is up 12% year-over-year.

With a run rate of over $2 billion and approximately 135,000 patients on therapy worldwide, AVONEX is the foundation of our market leading franchise in neurology.

In the US we have completed an expansion of our AVONEX sales force.

This expansion will increase our AVONEX share of voice and position us to take advantage of the recently released AVONEX 10-year CHAMPIONS data.

The results of this study have been positively received by physicians.

AVONEX pioneered early treatment of MS; and now, with the CHAMPIONS 10-year follow-up data, we're the only brand showing long-term benefit in early MS, also known as clinically isolated syndrome.

Dr.

Sandrock took you through some of the data, but the message is simple -- start AVONEX early and stay active longer than with delayed therapy.

Turning to TYSABRI, we had global in-market revenues of $254 million in the second quarter, a 27% increase compared to the prior year.

We continued to increase the number of patients on TYSABRI in the US and globally, and we have seen strong recovery in our patient growth rates.

During Q2 our weekly net new patient adds increased more than 50% from a Q1 average of about 170 a week to a Q2 average of more than 260 per week.

As we mark our third anniversary on the market this month, approximately 43,300 patients are receiving TYSABRI each month.

And of those, approximately 10,000 patients have now been on therapy for over two years.

At R&D day in March, we laid out our plans for driving reacceleration of TYSABRI growth -- be candid and honest with our customers, put the risk in perspective and then clearly communicate the benefits.

Our global commercial organization is now focused on maximizing the impact of new TYSABRI data discussed by Dr.

Sandrock.

Collectively, these unique data suggest that TYSABRI has the ability to slow and potentially stop or even reverse some symptoms of MS.

We believe that these strong data have helped physicians move past the shock of the first post-marketing case of PML and again focus on the compelling efficacy.

This continuing stream of evidence supporting TYSABRI's unprecedented efficacy is resonating with physicians, and we are seeing this translate into a reacceleration of patient growth rates to the highest level since July of 2008.

Dr.

Sandrock discussed some of the Fampridine-SR data and what it might mean to patients.

From a commercial perspective, Fampridine is a good strategic fit and supports Biogen Idec's commitment to bring new therapies to MS patients and expand our global MS leadership.

Fampridine fits nicely into the bag of our existing MS sales force.

We expect it to be used as a [concomitant] medication with disease-modifying therapies such as AVONEX and TYSABRI, as well as in patients with progressive forms of the disease, to help them maintain their mobility.

The partnership is highly synergistic with Biogen's existing MS infrastructure, so it will require limited incremental OpEx.

Biogen Idec's large global footprint provides significant access to non-US markets.

In conclusion, we are embarking on the second half of this year with an increased AVONEX sales force and unique new long-term efficacy data.

TYSABRI patient growth is reaccelerating well, and this quarter puts TYSABRI on a blockbuster run rate.

And we are very excited about our partnership with Acorda Therapeutics to bring Fampridine to the MS market as the first functional modifier to help MS patients keep the one thing they prize highly, their mobility.

With that, I'll hand it over to our CFO, Mr.

Paul Clancy.

I'll provide detail on our Q2 financial results and our updated 2009 guidance.

Q2 non-GAAP diluted earnings per share were $0.75.

This includes the impact of the $110 million payment to Acorda that reduced EPS by $0.32 this quarter and, we expect, will reduce EPS by $0.38 for the full year.

I'll explain in a bit more detail the tax impact for Q2 and the balance of the year.

Without the $110 million payment, Q2 non-GAAP EPS would have been approximately $1.07.

The GAAP financials are provided in tables 1 and 2 of the earnings release; table 3, you will find a reconciliation of GAAP to non-GAAP financial results.

Our Q2 GAAP diluted earnings per share was $0.49 including the Acorda upfront payment.

The primary differences between our GAAP and non-GAAP results for the quarter were $93 million related to the amortization of intangible assets, $6 million for pre-tax employee stock option expense and a $25 million tax impact related to these items.

Now I'll move on to the non-GAAP P&L operating performance of Biogen Idec, which we believe better represents the ongoing economics of the business and reflects how we manage the business internally and set operational goals.

Q2 total revenue was $1.093 billion, representing a 10% growth over the same period last year.

Q2 AVONEX worldwide product revenue was $591 million, representing a 12% increase over the same period last year.

Q2 US AVONEX product revenue was $366 million, representing a 20% increase over the same period last year.

On a sequential basis US AVONEX revenues were up 8%.

Units increased by nearly 2% versus Q1, and a March price increase accounted for the remaining growth.

We ended Q2 with approximately 2.3 weeks of inventory in the channel, essentially unchanged from Q1.

Q2 international AVONEX product revenue was $225 million, representing an increase of 2% on a year-over-year basis.

Units increased at double-digit rates versus prior year in both our direct and distributor markets.

This growth was offset by unfavorable foreign exchange impact of approximately $30 million on the international AVONEX sales.

Q2 TYSABRI worldwide Biogen Idec product sales were $188 million, a 27% increase versus Q2 2008.

In-market sales were $254 million, making TYSABRI a blockbuster drug on a run rate basis.

As Bob noted, we were encouraged to see a rebound in global TYSABRI patient demand during Q2.

Net new patient adds on a worldwide basis for Q2 2009 accelerated to average more than 260 per week versus about 170 per week in Q1 '09.

US end user in-market TYSABRI sales totaled $125 million.

Biogen Idec booked $57 million of this amount.

International end-user TYSABRI sales totaled $129 million.

The unfavorable impact of foreign exchange on Q2 TYSABRI international sales was approximately $13 million.

Combined, the unfavorable impact for both TYSABRI and AVONEX revenue for the quarter was approximately $44 million or greater than 5%.

Now moving to the RITUXAN collaboration revenues referred to as revenue from unconsolidated joint business, we recorded $276 million in revenue for the quarter, representing a decrease of 1% on a year-over-year basis.

Our RITUXAN revenues are broken down into three components; first, our share of the net US RITUXAN profits.

US RITUXAN sales were $696 million in the second quarter, up 7% versus prior year, and our profit share from that business was $199 million, up 12% versus prior year.

The year-over-year increase benefited from price increases and lower collaboration operating expenses.

Second, we received revenue on sales of rituximab outside the US, and in Q2 this was $60 million, down 29% versus prior year, driven by the expiration of our royalties on a country-by-country basis and unfavorable foreign exchange.

Lastly, we were reimbursed $16.7 million for selling and development costs incurred related to RITUXAN.

Q2 royalties for the quarter were $25 million.

Now turning to the expense lines in the P&L, which includes the non-GAAP adjustments that I described earlier, Q2 cost of goods sold were $91 million or 8% of revenues.

During Q2 we incurred only $2.1 million in write-offs related to unmarketable inventory.

This is what primarily drove the sequential quarter decline in COGS.

On a year-over-year basis COGS declined due to the expiration of certain third-party royalties on AVONEX.

Q2 R&D expense was $412 million, a 65% increase on a year-over-year basis and approximately 38% of revenues.

The drivers of this were the $110 million payment to Acorda and the continued progression of our late-stage pipeline.

Without the $110 million quarter payment, R&D expense grew by 21% on a year-over-year basis and was approximately 28% of revenues.

For the third quarter we expect R&D expense to be impacted by a milestone payment of $20 million to Cardiokine related to the progress on the lixivaptan program.

Q2 SG&A expenses were $216 million, representing 20% of revenues and an 11% year-over-year decrease.

The year-over-year comparison benefited from the strengthening dollar and G&A efficiencies.

Continuing down the P&L, our collaboration profit sharing line totaled $49 million in expense for the quarter.

Other income and expense for the quarter was a gain of approximately $15 million.

This was driven by $10 million of gain realized on marketable securities and strategic investments.

Specifically in the second quarter, we liquidated certain debt securities, all of our non-agency mortgage-backed securities and an investment in a biotech company, all for net gains versus book.

We ended the quarter with $2.7 billion of cash and marketable securities on the balance sheet.

Our Q2 non-GAAP tax rate was approximately 34.6%, which is higher than our normal effective tax rate.

The increase in the non-GAAP effective tax rate was driven by two factors.

First, certain stated items resulted in an unfavorable impact of approximately 200 basis points.

This is a discrete impact for Q2 only.

Second, the agreement with Acorda was entered into by an ex-US Biogen affiliate, and as a result there is no US tax benefit.

This resulted in an unfavorable impact for Q2 of approximately 500 basis points to the non-GAAP effective tax rate.

This will also increase our effective tax rate in Q3 and Q4 as non-discrete tax impacts are reflected across all quarters.

Specifically, we expect that our effective tax rate will increase in Q3 and Q4 by approximately 200 basis points to about 30% non-GAAP tax rate for Q3 and Q4.

This short-term unfavorable impact is obviously more than offset when the Fampridine business becomes cash flow positive.

This brings us to our Q2 non-GAAP diluted earnings per share of $0.75.

And without the Acorda payment, non-GAAP diluted EPS would have been $1.07.

Now I'd like to provide our updated 2009 guidance.

Revenue growth is expected to be in the high-single digits on a year-over-year basis, essentially unchanged from previous guidance.

Operating expenses excluding collaboration profit share are expected to be between $2.1 billion and $2.2 billion.

This now includes the payment of $110 million to Acorda Therapeutics.

R&D is expected to be approximately 28% to 30% of total revenue.

Balance of our year, R&D is expected to be between 26% and 28% of revenue.

SG&A is expected to be between 19% and 20% of total revenue.

Our non-GAAP tax rate is expected to be between 29% and 31% for the year.

As noted, the balance-of-year tax rate, non-GAAP, is expected to be approximately 30%.

Our GAAP tax rate expected to be between 30% and 32%.

Non-GAAP diluted earnings per share is expected to be above $3.85.

GAAP diluted EPS is expected to be above $2.75.

This now includes the Acorda impact for the year of approximately $0.38.

Additional note regarding TYSABRI -- we've been posting weekly updates related to PML on our website for more than six months.

In keeping with the plan we outlined in January, our final weekly website update about PML cases will be on July 24, the third anniversary of the reintroduction of TYSABRI.

Going forward, information about TYSABRI's benefit/risk profile will be communicated in a way that's much more consistent with other approved drugs.

So, in summary, Q2 was a very strong quarter for Biogen Idec that puts us on track to exceed our original full-year operating plan.

During Q2 we delivered accelerating TYSABRI growth with revenues now at a blockbuster run rate, solid AVONEX performance leveraging the 10-year CHAMPIONS data, progress in key pipeline programs including PEGylated interferon beta program, disciplined BD activity that expanded our pipeline to include the ex-US rights to Fampridine and the continued generation of significant operating cash flow.

I'll turn the call back to Jim for his closing comments.

Thanks, Paul, and I'll be brief.

In summary, business performance pipeline progress for the quarter was excellent.

We had double-digit revenue growth, reacceleration of TYSABRI patient growth, and completed the strategic Fampridine-SR ex-US licensing agreement.

We believe that the strong fundamentals of the business across all products and geographies will continue to deliver robust results and create significant value for our shareholders.

With that, Eric, we'll open up for Q&A.

Also joining us for the Q&A session will be Dr.

Evan Beckman, SVP of Immunology, Cardiopulmonary and Emerging Area R&D.

Celeste, we're ready to open up for Q&A now.

We ask the participants to please limit themselves to one question and then reenter the queue for follow-up questions.

Please state your name and company affiliation.

Operator, we are ready for the first question.

(Operator instructions) May-Kin Ho, Goldman Sachs.

You indicated that one should not really draw conclusions based on the low numbers of PML cases.

When do you think that we can actually draw some conclusions, including the optimal duration of therapy?

Well, I'll answer that question, May-Kin because I think it's relatively simple.

But it's not going to be terribly satisfying, I don't think, which is, when there's sufficient data both in terms of numbers as well as risk factors that point you in a direction.

And we're just not there yet.

So do you have any idea what is the approximate number of either cases or patients and -- or patient years that will (multiple speakers) --?

Well, obviously, as we wrap around having larger cohorts of patients that have been on the drug for 18 months, 24 months, 36 months, the confidence intervals on what the rate is, either cumulative or at any one of these intervals, gets better and better.

Probably, when you've got 10,000 or 15,000 patients that have passed 36 months, people will get comfortable.

But I do remember when people were talking about, well, it will be 12 months; well, it will be 18 months; well, it will be 24 months.

So I suspect, when we get to 36 months, people will be talking about 48.

Eric Schmidt, Cowen & Company.

Congrats on a great quarter.

Let me ask the obvious.

What kind of trends have you seen with TYSABRI over the last few weeks, post the string of cases that we saw, the PML cases we saw in June?

As we discussed, Eric, we've seen a re-increase and re-acceleration.

We are seeing more than 200 new patients on therapy each week on a worldwide basis, and this summer has some ups and downs.

But generally speaking, it's not been affected.

Steve Harr, Morgan Stanley.

As you've seen this string of cases, have you had any discussions with European or US regulators around potentially any change in the risk/benefit profile for TYSABRI?

We have been in regular conversations with European and US regulators and other regulators, for that matter, wherever this product is approved, since 2005.

So at this point I don't think there's any significant discussions about changing the label.

Bret Holley, Oppenheimer.

I've got a follow-up question to Eric's question.

I'm wondering, outside of the US, what the trends will look like on a weekly basis.

It seems like it's picked up, and I'm just wondering how you break it down, ex-US versus US, for TYSABRI.

They've remained very consistent, along with the US, in that regard.

So we've seen acceleration in both US and ex-US.

And the other thing I would note, this is something that we pointed out a few years ago, that we expected the ex-US sales and patient numbers would exceed the US.

And indeed, that's kind of where we are now.

Jim Birchenough, Barclays Capital.

I just wanted to add my congratulations on the quarter.

I'm just trying to understand better how each individual case of PML is reported to the clinical community.

I'm guessing clinicians aren't tuning into the website every Friday, so just wondering are clinicians sensitive to the string of cases we've seen recently?

And how is that communicated?

I think it varies by the clinician.

Much of what we do is word-of-mouth.

We have a large medical science liaison group.

They go out and communicate on a regular basis everything we know about TYSABRI, all the emerging data on efficacy as well as safety.

We also have medical information, a phone number, we have a website.

And also the medical directors in my group as well as in medical affairs have regular communication.

I think the amount of interest kind of varies from physician to physician.

Some, who actually have known about the risk for years, they accept it and they don't need a daily or a weekly update.

Others are a little bit more concerned and want more regular contact.

And I think the value of having a large MSL force is that they can tailor their communication according to the physicians' needs.

Michael Aberman, Credit Suisse.

I'm struggling whether to ask another question to try to get at the impact of duration versus cash.

Maybe, let's talk about cash for a second.

You guys have $2.7 billion in cash now.

You've done one licensing deal which didn't really use a lot of cash.

How are you thinking about the environment out there in terms of potential deals versus potentially returning some cash to shareholders through share buyback?

Well, our history has been, we have been very disciplined on the [BD].

I do think we are in an environment where the valuations of interesting assets are much more attractive.

We always measure any of these deals against what's the value of returning that same amount of money back to the shareholders.

And so I think my view is we are in an active period, and if we conclude that we really don't have great investment opportunities, then we will find a way to return it to shareholders.

But I think our view right now is that's premature.

Mark Schoenebaum, Deutsche Bank.

Congratulations on another well-executed quarter.

You keep squeezing more earnings out of this business than people think.

Just on a [quota], could you help us understand how many patients you think might be -- actually have problems walking or maybe express it in terms of a percent?

Just help us understand the commercial potential of that market.

I'm going to start with that, and then I may send that back to Al or Bob.

But there is a slide in this deck, and it's an important slide.

And I'm going to point it to you because it's the one that also shows the little man walking -- let's see, I don't know what number it is.

I guess it's number 11.

It's actually an Acorda slide.

I think what's interesting on that slide is, when you actually look at the span of people when you go out to clinicians and say, who are you likely to use this for, it certainly includes people who you would not traditionally conclude were going to be helped on the mobility scale because they are already EDSS 6 and above.

So clearly, the impression by clinicians that have used this product is it has a broader impact beyond the mobility endpoint that was measured for the approval in the US, and it would be the same endpoint in Europe.

So you have to think about it much more broadly because it's the same question I kept asking and asking and asking our team as they bring it back.

I'd say, how can we be thinking about people above EDSS 6, but in fact there is great interest in that category.

Maybe I'll turn it to Al now.

Well, mobility impairment is sort of the hallmark of the onset of secondary progressive MS.

A natural history study states that 50% of MS patients get this SPMS in about 10 years after the diagnosis.

So we all watch for loss of mobility, and as soon as we start to see it, we worry that we are entering into the SPMS phase of the disease, which is almost inevitable unless you are in the lucky 10% or so group that has benign MS, virtually everybody is headed towards SPMS at some time or another.

And in terms of people who benefit, in their Phase III trials when they looked at responders on the ambulation measure, we had two Phase III trials that had varied from 35% to 45%, sort of in that range.

But I would caution that that's probably an underestimate of who actually benefits from this drug because this drug would be predicted to affect more spheres beyond mobility.

In fact, many studies have shown that it may affect fatigue, vision, other important symptoms that MS patients deal with every day.

So ambulation has clearly been proven in the Phase III trial, and there are other published reports of improvements in other spheres.

And so, clearly, a large proportion of patients benefit.

And I think the point that Jim made is important.

Most of the patients in the Phase III trial actually had progressive forms of MS.

These are not patients that we are reaching right now with our drugs because our drugs are approved for relapsing forms of MS, so very important drug for MS patients.

Yaron Werber, Citigroup.

This is actually Karim Defilipe dialing for Yaron.

I have a question also on Fampridine.

Have you discussed with European authorities if they are going to accept the same endpoint that the FDA -- the SPA that was reached with the FDA, or is it going to be a different endpoint?

Can you give us any guidance in that sense?

There have been some preliminary discussions that Acorda had with the European regulatory agencies in various countries, and our understanding is that the endpoints are getting broad acceptance in Europe as well as in the US.

Geoff Porges, Sanford Bernstein.

A question on pricing for AVONEX.

Just if I take apart the numbers, it looks as though 80% of the AVONEX US number growth came from price, and that, in turn, was a big chunk of your total top-line growth.

And it looks as though as you've taken three 9% price increases over the past year or so.

Do you think that's really sustainable in the current environment?

Are you getting any pushback from your customers, from payers about these price increases?

Of course, we're seeing them across all the MS drugs.

Thanks.

No; I think your math is pretty accurate, Jeff.

As a matter of policy, we don't describe or talk about what our forward-looking plans are.

From a business plan point of view, I think that's probably the best indication, is we don't expect to be able to take material price increases going forward.

Geoff Meacham, JP Morgan.

A question for you on TYSABRI and PML.

Basically, have you seen -- as you guys have seen more PML cases, what can you tell us about antibody titers, the JC virus?

And do you think a seroconversion test could become part of a routine monitoring?

That's clearly one of the things we're very interested in right now.

We are examining that carefully.

We were fortunate enough to have pre-PML, pre-disease onset serum from some of these cases.

And it's clearly an area that is of high interest to us, and we are looking at it very closely.

Eun Yang, Jeffries.

You mentioned that you have seen rebound in the patient demand.

I'm just wondering, did you see a rebound in the number of doses used per patient as well?

Let's see.

If I understood that question, you are going after what's the compliance.

So if patients are supposed to get 12 doses year, do they get 12?

Yes.

I'll give that to Paul because he's probably got the granular data.

Yes.

I think what we certainly saw and we had pointed out in the back end of 2008 is that we saw a bit of a slippage in that, and then the first kind of a few weeks going into 2009 as well.

That did have a modest impact on some of the sales figures for TYSABRI in Q4, and then in Q1, and particularly when people started looking at price per patient, as we did as well.

It has come back to what I would characterize as more normal levels.

I wouldn't characterize it as it has rebounded past anything more normal, but it has come back to more normal levels.

So that's, I think, the best way to characterize this.

Joel Sendek, Lazard Capital Markets.

I have a question on Fampridine as well.

So if the endpoints are pretty much the same and the discussions are already underway, or at least Acorda started the discussions on ex-US filing, I'm wondering why it might take up to a year to get the filing in, according to your guidance.

The teams are really just digging into all the file at this point.

Obviously, we did some of that during the diligence exercises.

And I think, within this quarter we will have a much more granular view of what that's going to take.

But we also -- we will be taking the lead on preparing the filing.

Of course, we need to work with the Acorda folks on that, and we will take the lead with discussions with regulators.

But until we've really dug into that, I think we'd just put a conservative number out there.

Sure hope to beat it.

Ian Somaiya, Thomas Wiesel Partners.

Congratulations on the good quarter.

I had a question for Al.

I was just opening to get his perspective on what has classically been the types of disabilities and maybe disability rates and mortality rates with PML, and what the experience has been with TYSABRI.

Just trying to tease out what impact your vigilance has had on improving outcomes for patients who do experienced PML.

Well, I think this is the one thing that I think we are pretty confident that the risks may have decreased.

If you look at our label since reintroduction, it states that TYSABRI -- that PML is usually fatal.

But I gave you the numbers in the post-marketing cases.

Nine out of 10 patients are alive now.

It's still early days for some of the later patients.

But our view is that the clinical vigilance has worked, that a lot of people are following our guidelines, which were to suspend TYSABRI if there's any question that it could be PML.

There's a lot of people doing that, doing MRI scans as necessary, using the required baseline scan for comparison and also doing the CSF test.

And so I believe that all of these factors have helped in early detection in many of these cases, and I think that's one of the reasons why survivability has been better than I think was predicted when the drug was reintroduced in the United States.

Can you talk about the disabilities that are experienced by these patients?

Well, it's a broad range.

There have been some success stories, but some patients haven't gotten quite to where we would like them to be, and one patient has passed away.

So I think there's more work to do.

That's why we're doing the Mefloquine controlled clinical trial, and that's why we would like to look for risk mitigation strategies.

But I think we're somewhat encouraged, I think, by the fact that early detection, and we think the plasma exchange also has helped to remove the effect of TYSABRI.

Jason Zhang, BMO Capital.

Question for Dr.

Sandrock -- if what we have seen lately is going to happen in the future, it seems that the cases of PML might be duration related.

And I know you are strongly opposing drug holiday some physicians by doing that.

You know, there is not a scientific basis for that.

But I'm just wondering, as we go forward, duration of treatment is going to be longer for a majority of the patients.

And physicians might start wondering about some type of strategy of drug holiday.

Rather than just letting physicians do that on their own, would it be better for the company to have some structural plans, if that's possibly one of the mitigating strategies going forward?

Yes.

So, in terms of duration, we did have three cases in three weeks, in the longer-duration sort of period.

But we've had two weeks without cases, and we have 1000 patients entering into the greater than two-year duration now per month.

So I think we're going to get a lot more clarity.

In terms of drug holidays, the reason why we've cautioned against this is that we know that you get return of disease activity.

Many of these patients went on to TYSABRI because they have bad disease, highly active disease, even on first-line therapy.

So we were cautioning against drug holidays.

That doesn't mean that we -- we did the plasma exchange study, for example, to be able to provide guidance to physicians in the event of PML.

Should we do something like that?

We're thinking about it.

I should say that, whatever we do, we're going to take leadership in that, and we will provide guidance when and if the time is right to do that.

Maged Shenouda, UBS.

Do you have any commentary on why there are more reported PML cases ex-US versus US?

And have regulators drilled down on this with you?

Well, we've had regular contact with the regulators, and it is clearly something that has caught our attention, has been for some time now.

We have eight cases outside of the United States and two inside.

We have looked at multiple factors, including prior suppressive agents.

We've looked at the virus.

We've genotyped the virus in as many cases as we can get a hold of the virus.

And so far, we have not come up with a firm conclusion as to what is going on.

But it's clearly something that we are very interested in, and it could provide a clue.

And it may provide some insight into risk mitigation strategies in the future.

Josh Schimmer, Leerink & Swann.

Thanks for taking the question.

It's related to Jeff's earlier question on predictors of PML and TYSABRI.

We've heard that there's a peripheral lymphocyte functional assay that may be useful to evaluate the degree of immunosuppression on TYSABRI.

And I'm wondering whether you see such an assay having a role in patient management and titrating dosing to avoid over-immunosuppression.

And are there any studies under way to evaluate such an approach?

We see no evidence of peripheral immunosuppression with TYSABRI.

In fact, if anything, it's the opposite; we see an increase in peripheral blood mononuclear cells because of the TYSABRI mechanism of action.

We are looking at it, though, because, as I said, the premise of our risk mitigation strategies includes the presence of virus and also immune competence.

And we're evaluating commercially available assays, such as the Cylex assay.

We're evaluating other assays, such as the CDA response to BP-1.

There have been some recent publications on that.

It is something that we are very interested in following up on, but it's still work in progress.

Mike King, Merriman Curhan & Ford.

Thank you; my questions on Fampridine were answered.

Eric Schmidt, Cowen and Company.

The question is for Paul, on the guidance for the year.

The EPS guidance is still open-ended, and if I do the math correctly, if you continue on your current quarterly non-GAAP earnings run rate, you'll do $3.94 in non-GAAP EPS for the year.

So I guess my question is, is there any reason we should think that either Q4 or Q3 might be a down quarter?

Is there fewer AVONEX selling days to be aware of or any other increases in spending other than the milestone payment you already highlighted?

No.

I think I would note, as I made in the call, that there's a $20 million milestone associated with the lixivaptan program.

Also, just note the tax rate for the next two quarters bumps up versus our normal tax rate.

But I think we are trying to put out numbers that we feel confident that we have a really strong chance of getting towards, and we will continue as usual to push the business as hard as we can for shareholders.

Steve Harr, Morgan Stanley.

I just had a question.

It struck me as you said, there are no peripheral immunosuppressive effects of TYSABRI; how the drug, then, is efficacious in diseases outside of the CNS.

It clearly must have some impact, right, or it wouldn't have an impact in Crohn's disease.

And we saw impacts in rheumatoid arthritis back in -- seven or eight years ago.

Is that fair?

Well, the drug, we believe, works by blocking the trafficking or entry of peripheral blood cells into tissues, such as the central nervous system and the GI tract.

And so, when you take cells out of the peripheral blood and you examine their immune functions, they are normal in the ways that we've studied them.

So that's what I meant.

Geoff Porges, Sanford Bernstein.

Just a quick question on other adverse events -- there's been one report of CNS lymphoma in a patient treated with TYSABRI that's been published.

I'm just wondering if you've been notified about any other cases of that condition or similar conditions in the patients who have been treated with the drug.

Thanks.

Yes, we've known about that case for over a year; in fact, it was included in our periodic safety update report that we provide to regulators.

This was a case that occurred after 21 infusions.

We did a causality analysis when we got the case over a year ago; and, based on the pre-clinical study, the controlled clinical trial data as well as the post-marketing data, we have -- we believe that primary CNS lymphoma is not causally linked to Natalizumab therapy.

We believe the rate of this disease is consistent with the background rates observed in the general population.

I would also note that in this particular case that the lymphoma was EBV-negative.

And as you know, this disease can occur in immunoconfident individuals.

When it occurs in immunosuppressed individuals, more than 90% of the time it's EBV-positive.

So for all these reasons, we don't believe there is a causal link between Natalizumab and primary CNS lymphoma.

Celeste, we have time for just one more question.

Geoff Meacham, JP Morgan.

A question for Paul -- your EPS guidance for the rest of the year -- can you tell us what you assume here for RITUXAN ex-US?

Would you expect continued declines from here, or sort of stability at near Q2 levels?

Good question.

I think it's best -- because that would be the other factor, I think, add on from Eric's question.

I think there's going to be modest declines as we keep going through the country-by-country rolloff.

The first half saw the majority of what -- the country-by-country rolloff effect.

We were impacted in Q2 negatively by foreign exchange.

I don't think it's the rate of rolloff.

I think, prior, I had guided to kind of high -- around $270 million.

I think it probably ends the year probably $240 million to $250 million to Biogen Idec in terms of RITUXAN and rest of world royalties.

That was our last question.

We thank you for your participation in today's call.

You may now disconnect.