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Proxy Communication Statement
Biogen Idec and its directors, executive officers and other members of its management and employees
may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen
Idec in connection with the Companys 2008 annual meeting of stockholders. On April 18, 2008,
Biogen Idec filed a preliminary proxy statement with the Securities and Exchange Commission (the
SEC) and will file a definitive proxy statement and other materials concerning the proposals to
be presented at the Companys 2008 annual meeting. Information concerning the interests of
participants in the solicitation of proxies is included in the proxy statement.
THE PROXY STATEMENT CONTAINS IMPORTANT INFORMATION ABOUT BIOGEN IDEC AND THE 2008 ANNUAL MEETING OF
STOCKHOLDERS. Biogen Idecs stockholders are advised to read carefully the proxy statement, and any
amendments or supplements thereto, and other materials filed by Biogen Idec in connection with the
Companys 2008 annual meeting of stockholders, when available, before making any voting or
investment decision. The Companys proxy statement and other materials, as well as the annual,
quarterly and special reports filed with the SEC, when available, can be obtained free of charge at
the SECs web site at www.sec.gov or from Biogen Idec at www.biogenidec.com. The
Companys definitive proxy statement and other materials will also be available for free by writing
to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142 or by contacting our proxy solicitor,
Innisfree M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at
info@innisfreema.com.
CORPORATE PARTICIPANTS
Elizabeth Woo
Biogen Idec VP of IR
Jim Mullen
Biogen Idec CEO, President
Bill Sibold
Biogen Idec SVP, U.S. Neurology Business Unit
Dr. Cecil Pickett
Biogen Idec President R&D
Paul Clancy
Biogen Idec CFO, EVP Finance
CONFERENCE CALL PARTICIPANTS
Mark Schoenebaum
Bear Stearns Analyst
Kareem De Felipe
Citi Analyst
Joel Sendek
Lazard Capital Markets Analyst
Michael Aberman
Credit Suisse Analyst
Geoff Meacham
JPMorgan Analyst
Eric Schmidt
Cowen & Co. Analyst
William Ho
Banc of America Analyst
Jim Birchenough
Lehman Brothers Analyst
May-Kin Ho
Goldman Sachs Analyst
Bill Tanner
Leerink Swann Analyst
Mike King
Rodman & Renshaw Analyst
Maged Shenouda
UBS Analyst
Adam Walsh
Jefferies & Co. Analyst
Jason Zhang
BMO Capital Analyst
George Farmer
Wachovia Securities Analyst
PRESENTATION
Operator
Good morning; my name is Janice and I will be your conference operator today. At this time I
would like to welcome everyone to the Biogen Idec first-quarter 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). Ms. Woo, you may begin your conference.
Elizabeth Woo - Biogen Idec VP of IR
Thank you. Welcome to Biogen Idecs first-quarter earnings conference call. Before we begin
Id ask everyone to go to the investor relations section of our website, BiogenIdec.com, and print
out the press release and related financial tables. These will be particularly useful when our CFO,
Paul Clancy, reviews the financial results and reconciliation to non-GAAP financial measures
discussed today. Weve also posted the slides on our website that outline the topics discussed on
todays call.
Ill start with the Safe Harbor statement. Comments made in this conference call include
forward-looking statements about the Companys expectations regarding future financial results,
including our 2008 financial guidance, our longer term operational and financial goals, sales
potential of TYSABRI and plans for external growth and pipeline advancement. Such statements are
subject to risks and uncertainties which could cause actual results to differ materially from
expectations.
In particular, careful consideration should be given to the risks and uncertainties that are
described in our earnings release and in Item 1A of the Companys reports on the Form 10-K and Form
10-Q and in other periodic and current reports Biogen Idec files with the SEC. The Company does not
undertake any obligation to publicly update any forward-looking statements.
In addition, because we have received a Board of Directors nomination and bylaw amendment proposal
from one of our shareholders, we are obliged to inform you of this and to be sure that our
stockholders have access to all information they might need around this process.
On todays call Im joined by Jim Mullen, CEO of Biogen Idec; Bill Sibold, Senior Vice President
U.S. Neurology Business Unit; Dr. Cecil Pickett, President of R&D; and Paul Clancy, Chief Financial
Officer and EVP of Finance. I will now turn the call over to Jim.
Jim Mullen - Biogen Idec CEO, President
Thank you, Elizabeth. Good morning, everyone, and thanks for joining us. Q1 2008 was another
great quarter. We delivered record revenues and outstanding financial results in the first quarter
as we more than tripled TYSABRI sales compared to the same period last year and our core products,
AVONEX and RITUXAN, continue to generate strong sales. We made an outstanding start to 2008 and
were well on our way towards achieving our goals for 2010.
We delivered record revenue and strong profits in Q1 and year-over-year revenues grew 32% and
non-GAAP earnings grew 41%. We saw an acceleration of TYSABRI patient adds as physicians grow more
comfortable with the safety profile. We added 5,000 new patients in Q1 with more than half of them
internationally and, importantly, no new cases of PML have been reported since the relaunch.
AVONEX sales were very strong and outperformed expectations. AVONEX continues to maintain its
worldwide leadership position in the competitive MS marketplace and provides a strong and growing
cash flow contribution to the business. And we advanced our pipeline. Clinical trial activities
ramping up significantly in 2008 and were eagerly awaiting a series of new clinical data reports
this year for products not yet considered in our long-term forecast.
So 2008 is shaping up to be another strong year from both a financial and clinical standpoint and
were raising full-year 2008 guidance. So let me just expand on a few points before I turn it over
to others on the call.
RITUXAN U.S. net sales for Q1 were $605 million which is up 13% year over year. This translates
into revenues from the related joint business were $247 million which is up 19% year over year.
AVONEX worldwide sales were $536 million in Q1 2008 representing a 19% growth year over year. With
TYSABRI we exited the first quarter at a run rate of over $600 million of in-market revenues
globally. Between AVONEX and TYSABRI our MS franchise share continues to expand. Bill Sibold, the
SVP U.S. Neurology, will take you through the good news for TYSABRI.
And as we start 2008 we see a continuing acceleration towards our goal of 100,000 patients on
TYSABRI by year-end 2010. As a result were raising full-year non-GAAP 2008 earnings guidance. CFO
Paul Clancy will take you through the financial and guidance details.
A couple of comments on the pipeline our pipeline advanced for 2007 and we now have 15 products
in Phase II and beyond and 2008 will be a year of a significant number of clinical readouts. We
built this impressive pipeline with a balanced approach of organic development and execution of
highly effective business development programs. Significant R&D investment has yielded a robust
pipeline with four novel compounds in registration trials and another to start later this year.
While were disappointed with the RITUXAN OLYMPUS trial and it was unable to meet the primary
endpoint in the difficult-to-treat primary progressive MS setting, we have a number of meaningful
data readouts as the year goes on and Cecil Pickett will review the pipeline accomplishments and
upcoming milestones in his comments.
Ill conclude the introduction by saying the future of Biogen Idec is extremely bright as evidenced
by our recent operating results. In my nearly two decades with the Company I dont believe the
prospects for growth today and growth in the future have been any better for the Company. Ill now
turn the call over to Bill Sibold, the head of the U.S. Neurology business.
Bill Sibold - Biogen Idec SVP, U.S. Neurology Business Unit
Thanks, Jim. Im pleased to report that in Q1 we continued the momentum established in 2007.
Biogen Idecs global MS franchise continues to grow everyday with more new patients entering the
franchise.
No one is doing more for MS than Biogen Idec. We have the number one prescribed MS therapy today,
AVONEX; we have the product that has established a new level of efficacy, TYSABRI, which has been
shown to delay the progression of the disease and reduce relapses by two thirds; and we have the
best and broadest pipeline of MS products for the future.
This reality distinguishes us from other companies in the market and positions us, unlike any
other, for the future. More and more physicians that I talk to understand and appreciate this
commitment which I believe positively impacts both the short- and long-term prospects for the
business.
Our presence in MS was highlighted at AAN in Chicago last week where there were nine platform
presentations and 27 poster presentations related to Biogen Idec products. This is double the next
closest competitor for total presentations, once again demonstrating the breadth of our portfolio.
We also had a corporate therapeutic update titled Multiple Sclerosis, Biogen Idec and the Future of
Personalized Medicine which was oversubscribed with more than 500 attendees.
Turning to Q1 results global neurology revenues were $650 million $651 million, an increase
of 10% versus the prior quarter and 36% versus the prior year. Our combined global franchise market
share continues to grow. In the U.S. it is now at its highest level since 2005 and it is at its
highest level since 2000 outside the U.S.
We expect this trend to continue in step with TYSABRIs growth. AVONEX remains the product to start
with and TYSABRI for those patients needing more efficacy. With their clear positioning and strong
product profiles the bulk of relapsing remitting MS patients are candidates for either AVONEX or
TYSABRI. As our pipeline matures we will have new options for additional patients in need.
Looking specifically at the products, AVONEXs $536 million in global revenue in Q1 was up 19% year
over year and 7% quarter over quarter. AVONEXs revenue was up 14% year over year in the U.S. and
27% year over year internationally.
With over 135,000 patients on therapy worldwide and over 1 million patient years of experience,
AVONEX remains the foundation of our global MS business. After 11 years on the market, AVONEX
remains the only once-weekly product and is the only product indicated to both slow the
accumulation of physical disability and be effective for patients who have experienced a first
clinical episode and have MRI features consistent with MS.
Perhaps this is why it is the treatment most associated with patients in the early stages of the
disease and with those patients who lead an active daily lifestyle and why it is the number one MS
therapy in the world. AVONEX disrupts disease, not patients lives.
Now to TYSABRI. TYSABRI continues to build momentum with in-market revenue of $160 million in the
quarter which is 23% growth over the prior quarter and an over three-fold increase over the prior
year. At the AAN meeting in Chicago last week we announced the latest patient
numbers for TYSABRI. As of late March there were approximately 26,000 patients on TYSABRI worldwide
in the commercial and clinical trial setting. There were approximately 15,300 TYSABRI patients in
the U.S. with about 2,750 prescribing physicians, which is a doubling in the number of prescribers
since last year. Internationally there were about 10,200 patients on therapy.
Finally, we announced that there were over 9,900 patients on therapy for over one year and over
3,600 on therapy for more than 18 months. The update was very well received by physicians who are
growing more and more comfortable with the benefit/risk profile of TYSABRI.
Also at AAN, a poster was presented that showed that TYSABRI treatment significantly increases the
proportion of patients with MS considered to be disease free. According to post-talk analysis of
the AFFIRM and SENTINEL clinical trials about one-third of patients were shown to have no relapses,
no disability progression and no new MRI markers.
Additionally, at AMCP and AAN last week, a poster was presented with results from a recent study of
451 patients on TYSABRI. The study showed that over 95% of patients reported doing as well or
improving in their quality of life, functional status and disease step levels as early as three
months after starting TYSABRI.
Additionally, over half of the patients reported improvements in their ability to do physically
demanding tasks and feeling well in the same period. These data suggest the real-world efficacy of
TYSABRI.
Also since the last call, our partner Elan has launched TYSABRI for Crohns Disease and TOUCH
online has been rolled out and has been extremely well received. TOUCH online offers substantial
service benefits to our prescribers and infusion sites.
Additionally, we continue to see encouraging trends in the market. Worldwide, TYSABRI is considered
to be the most effective MS therapy by neurologists. In the U.S. the number is over 94% of
neurologists responded this way. Positive switching trends continue with TYSABRI being the most
switched-to therapy. And on the subject of switching, in the U.S., Copaxone with its everyday
injection remains the largest single source of TYSABRI patients.
Finally, about 80% of TYSABRI patients in the U.S. and nearly 90% of TYSABRI patients
internationally are new to the Biogen Idec franchise. We believe TYSABRI will continue to build
momentum throughout the remainder of 2008. We had a strong Q1. There continues to be positive new
data about TYSABRI as evidenced at AAN last week, and in July TYSABRI celebrates two years on the
market, which is a significant milestone. All of these things make us more confident than ever that
TYSABRI will achieve the previously stated goal of 100,000 patients on therapy and eventually
become the leading MS therapy in the world.
In conclusion, with the number one prescribed MS therapy today, AVONEX, a product that has
established a new level of efficacy, TYSABRI, and the best and broadest pipeline of MS products for
the future, Biogen Idec is the leader in multiple sclerosis. Our goal is to provide products and
services for MS patients from diagnosis to disease resolution. We are extremely pleased with the
results of the first quarter and optimistic about the rest of the year and the future. I will now
hand the call to Dr. Cecil Pickett, President R&D.
Dr. Cecil Pickett - Biogen Idec President R&D
Thank you, Bill, and good morning, everyone. Today Ill report, as usual, on accomplishments
in the quarter and upcoming data readouts. First Ill review recent progress and data readouts.
As you know, our sBLA on TYSABRI to treat Crohns disease was approved by the FDA on January 14th.
Our partner, Elan, has since launched the drug and TYSABRI for Crohns has been available in the
U.S. since the end of February, with final stages of education and training completed during the
second week of March. Crohns patients have started to receive TYSABRI therapy in the U.S. and we
are pleased to offer them this important option.
We had a recent data readout and were disappointed that our RITUXAN OLYMPUS trial in primary
progressive MS failed to meet the primary endpoint. The unmet medical need remains high in this
difficult-to-treat disease.
Next Ill mention some data on TYSABRI. Starting with PML mitigation, Dr. Fox presented at AAN a
sub study from the PLEX trial on leukocyte transmigration that suggested plasma exchange could be
an effective means of removing TYSABRI and allowing the immune system to reestablish more rapidly.
In theory this may allow a patient to better fight off a reactivated JC virus.
Staying with PML mitigation, we have initiated a program to test the anti-malarial Mefloquin in HIV
patients with PML. Mefloquin has shown some antiviral activity in an in vitro screening of JC virus
replication.
Moving to safety, at the recent AAN meeting our global head of drug safety, Dr. Carmen Bozic
presented an update of TYSABRI safety and, as you know, weve seen no new PML cases. As Bill
mentioned, physicians are growing more and more comfortable with the benefit/risk profile of
TYSABRI.
To provide additional perspective, PML is associated with a growing list of immunosuppressive
drugs. So it may be time to start considering PML as a potential side effect of any powerful
therapy that modulates the immune system and not as something specific to TYSABRI.
Next, we had a number of R&D accomplishments this quarter. We continue to make good progress on
advancing and developing our late stage clinical pipeline. We currently are accruing patients to
our four ongoing pivotal registration programs with novel molecules, lumiliximab and CLL, galiximab
in non-Hodgkins lymphoma, BG-12 in relapsing remitting MS, and lixivaptan in hyponatremia. In
addition, we expect to initiate another pivotal program during 2008, ADENTRI in acute decompensated
congestive heart failure.
We have completed enrollment for the RITUXAN Phase III LUNAR trial in lupus, nephritis and the
baminercept alpha Phase IIb respond trial in rheumatoid arthritis. We have achieved first patient
enrolled for the daclizumab Phase II SELECT monotherapy trial in relapsing remitting MS; the
volociximab Phase II combination trial with DOXIL in ovarian cancer; our lead HSP-90 inhibitor
Phase II trial in gastrointestinal stromal tumors; and the anti-IGF-1R Phase I trial in solid
tumors.
Finally, we have active INDs for TYSABRI in multiple myeloma and anti-Cripto-DM4 for solid tumors.
We also published an in vitro study of Neublastin in nature and neural science. Neublastin promoted
regeneration of damaged sensory nerve cells and restored sensory and motor function. And also keep
on the lookout for a number of abstracts from us at the upcoming ASCO and UR meetings.
Ill end by reminding you about the number of data readouts expected by the end of 2008. Soon we
anticipate results from Explore, the Phase III RITUXAN study in SLE. The BILAG scale will be used
to assess SLE disease activity in this study and is a comprehensive, reliable, sensitive to change
and effective in capturing the waxing and waning nature of lupus. Major or partial clinical
response will be assessed at 52 weeks. The unmet medical need remains high in this sizable
indication.
We also expect to see clinical readouts in 2008 from a number of novel programs including Phase IIb
data on baminercept alpha in RA, BIIB14 for Parkinsons disease, and long-acting Factor IX in
hemophilia B. Also our heat shock protein 90 inhibitor in volociximab in solid tumors.
So in conclusion, I remain very impressed with the caliber of both the pipeline and our R&D team.
2008 is a very active year on the R&D front and on average four times as many patients in clinical
trials compared to 2007. We are as eager as you to see the data from the ongoing trials. With that
Ill hand the call over to Paul Clancy, our CFO.
Paul Clancy - Biogen Idec CFO, EVP Finance
Thanks Cecil. We delivered another strong quarter of financial results. Our impressive
top-line and bottom-line growth is a solid testament to Biogen Idecs economic growth engine and
our focus on delivering tangible results and building shareholder value.
We achieved 32% top-line growth with strong performance across all products in all geographies and
over 40% earnings growth on a year-over-year basis. We delivered these excellent financial results
while simultaneously investing heavily in our pipeline, a key imperative for sustainable long-term
growth.
Now Ill walk through the P&L in more detail. The GAAP financials are provided in Tables 1 and 2 of
the earnings release. Table 3 is a reconciliation of the GAAP to non-GAAP financial results. So
lets begin with our GAAP to non-GAAP reconciliation. In accordance with Reg G weve provided Table
3 which breaks out the items by major driver.
The main items excluded from the non-GAAP P&L in Q1 were first, we adjusted $75 million for the
amortization of intangibles; second, we adjusted $25 million related to the contingent
consideration payment associated with the Conforma acquisition; third, we adjusted $6 million in
employee stock option expenses, approximately half of this is in SG&A and the remainder in R&D; and
fourth, we had $18 million of tax impact for the items I just mentioned.
Now Ill move on to the non-GAAP P&L operating performance. We believe its important to share this
non-GAAP perspective with shareholders because it better represents the ongoing economics of our
business and it reflects how we manage the business internally and set operational goals.
In Q1 we delivered $0.54 diluted EPS on the GAAP P&L and, after the adjustments shown in Table 3,
our non-GAAP diluted EPS was $0.83. Both of these numbers increased by over 40% versus Q1 2007.
Now lets move through the first-quarter detail in a bit more. Q1 total revenue was $942 million.
This represents an impressive 32% growth over the same period last year. Key drivers again across
all products, all geographies, the continued revenue growth of the AVONEX business, the increasing
penetration of TYSABRI, and the continued growth of the RITUXAN franchise.
Now Ill go through the product revenues; Ill begin with AVONEX. Q1 AVONEX worldwide product
revenue was $536 million representing a 19% increase over the same period last year. Q1 U.S. AVONEX
product revenue was $308 million representing a 14% increase over the same period last year. This
revenue growth was supported by the strength of the AVONEX brand and its ability to support price
increases in 2007.
Q1 international AVONEX product revenue was $228 million representing an increase of 27% on a
year-over-year basis. Approximately 10% of that increase was driven by favorable foreign exchange
rates and the balance driven by volume and mix increases.
Q1 TYSABRI worldwide Biogen Idec product revenue increased to $115 million. As Bill highlighted,
TYSABRI continues to make strong progress. TYSABRI financial highlights include inpatient total
sales of $160 million worldwide. U.S. end-user TYSABRI sales totaled $86 million representing a 13%
quarter-over-quarter increase. Biogen Idec booked $41 million of this amount. International
end-user TYSABRI sales totaled $73 million which is a 39% increase from the prior quarter.
Moving to other product revenue, Q1 FUMADERM revenue was $12 million and Q1 ZEVALIN product sales,
which really represents our supply agreement with CTI, were $2 million.
Now moving on to the RITUXAN collaboration revenues, which is referred to as revenue from
unconsolidated joint business, we recorded $247 million in revenue for the quarter representing a
19% year-over-year increase. This number has three elements first, we receive our share of the
U.S. RITUXAN profits. As reported by Genentech our partner, U.S. RITUXAN sales were $605 million in
the first quarter, up 13% versus prior year. And our Q1 profit share from that business was $158
million, up 16% versus prior year.
Second, we receive royalty revenue on sales of rituximab outside the U.S. and in Q1 this was $77
million, up 35% versus prior year. Third, we were reimbursed $13 million for selling and
development costs incurred related to RITUXAN. Q1 royalties were $24 million for the quarter. Our
Q1 royalty revenue reflects a step down from Q4 driven by ANGIOMAX which I described in our last
call.
Now turning to the expense lines on the P&L, which includes the non-GAAP adjustments that I
described earlier. Q1 COGS were $101 million representing 11% of revenues. Q1 R&D expense was $255
million which is approximately 27% of revenues. Increases in our R&D spend was driven by our
continued advancement of our robust pipeline.
As Cecil mentioned, we have several programs in registrational trials including BG-12, lixivaptan,
galiximab and lumiliximab, and we expect ADENTRI to join this group by the end of the year. We
expect these late stage programs coupled with our advancing early-stage pipeline to drive
significant increase in the number of patients on clinical trials when comparing 2008 to 2007.
Q1 SG&A expenses were $213 million which represents 23% of revenues and a 17% year-over-year
increase. Drivers of the year-over-year increase in absolute dollars included investments to
support TYSABRI growth. Specifically several international markets including Germany and France as
well as the Crohns launch in the U.S. in the first quarter of 2008.
Continuing down the P&L, our collaboration profit-sharing line totaled $21 million of expense for
the quarter. As a reminder, this line represents Biogen Idecs payment of 50% of the profits
outside the U.S. to Elan and the reimbursement of third-party royalties incurred by Elan outside
the U.S. We expect this number to continue to grow in the coming quarters reflecting the growing
profitability and uptake of our international TYSABRI business.
Now moving to other income and expense. This represented a $500,000 loss for the quarter, a
significant change to our OIE line since the same period last year is the impact of our $3 billion
share repurchase in June of 2007 which equated to 16% of our shares outstanding. Specifically this
line has been impacted by the loss of interest income from a reduction in cash and the addition of
the interest expense from taking on debt.
Ill also note that during the quarter we converted our $1.5 billion temporary bridge loan to $1
billion in permanent debt. The $500 million difference was paid down with cash. The permanent debt
offering included $450 million in principal at 6.0% due 2013 and 515 $550 million in principal
at 6-7/8% due 2018.
Additionally, in Q1 2008 we repurchased 4 million shares under the 20 million share repurchase
program authorized by our Board of Directors in October of 2006. The purpose of this program is for
share stabilization. Since the close of the quarter an additional 5 million shares have been
purchased as well. Even after our impressive share buybacks our cash position remains strong and
growing.
Q1 tax rate on a non-GAAP basis is 29% which brings us to our Q1 non-GAAP diluted EPS of $0.83,
again representing a 41% increase over the same period last year.
Now Id like to conclude by discussing our updated 2008 guidance. Given our strong Q1 performance
were raising our 2008 financial guidance. We expect annual revenue growth of 20% over 2007 driven
in large part by strengthening TYSABRI uptake. This is now at the high end of our previous revenue
guidance.
We expect operating margin leverage to be similar to previous guidance and the combination of
non-GAAP R&D and SG&A expenses for the year to be approximately $2 billion. This number may be
impacted by potential business development activity and the pace of patient accruals in our
important four, and moving to five, late stage development programs.
Ive excluded from Ive excluded are collaboration profit line from the $2 billion expense
guidance for 2008. I should note that we do expect this line to grow each quarter, again reflecting
the uptake in increasing profitability of the international TYSABRI business.
Our non-GAAP tax rate is expected to be between 28 and 30% and this assumes the renewal of the R&D
tax credit legislation. Non-GAAP diluted EPS is expected to be in the range of $3.25 to $3.45, this
represents a 19 to 26% year-over-year growth rate.
In addition to increasing our guidance weve slightly widened the range to reflect the potential
impact of business development activities and the pace and success of clinical trials, notably
again the four to five programs in late stage. GAAP EPS is expected to be in the range of $2.28 to
$2.48.
Overall this full-year guidance provides strong top-line and bottom-line growth and is an important
steppingstone in achieving our longer-term operating and financial goals. So in conclusion,
extremely strong performance for the quarter with a solid testament to our strategy and our focus
on creating shareholder value. We delivered 32% in the top line and grew non-GAAP EPS by 41%, all
while aggressively investing in our pipeline. Now I will hand it over to Jim for his closing
comments.
Jim Mullen - Biogen Idec CEO, President
Thanks, Paul. In summary, were very pleased with the Q1 2008 financial results and the strength
across all products. Given the strong momentum underway and the key data readouts expected later
this year the prospects for the Company have never been better.
We continue to grow our MS franchise share. By year-end several thousand patients will have been on
TYSABRI therapy for two years which will provide the MS community with a better understanding of
the impact of duration of TYSABRIs safety profile.
Were moving our pipeline programs forward and a number of data readouts on late-stage programs
will come over the next month. The next readout will be the top-line results for RITUXAN in lupus
which will be available soon, certainly in this quarter.
The future of Biogen Idec is bright; we continue to work to bring more meaningful therapies to
patients in need which in turn we believe will generate strong growth that will create significant
value for our shareholders. Just as we did successfully over the prior four-year period, were
confident we will achieve our 2010 goal. And just to reiterate those 2010 financial goals, its 15%
revenue compounded annual growth rate, 25% GAAP EPS compounded annual growth rate, and 20% non-GAAP
EPS compounded annual growth rate. With that Ill turn it back over to Elizabeth and open it up for
Q&A.
Elizabeth Woo - Biogen Idec VP of IR
Thanks, Jim. Operator, were now ready to open up the call for Q&A and wed ask participants on the
call to please limit themselves to one question and then reenter the queue for any follow-up
questions. Please state your name and company affiliation. Operator (multiple speakers) first
question.
QUESTION AND ANSWER
Operator
(OPERATOR INSTRUCTIONS). Mark Schoenebaum, Bear Stearns.
Mark Schoenebaum - Bear Stearns Analyst
Thanks for taking my question, I really appreciate it. Can I ask about RITUXAN for lupus? And
obviously I know you dont know the data yet, so Im not going to put you in that uncomfortable
position of trying to handicap those data. But maybe you can just help the Street perhaps
understand this market a little bit better.
There have been all kinds of sell side reports coming out and Genentech has given out I think
200,000 eligible patients. I see on your slide it looks like its closer to 300,000 eligible
patients. In reality, kind of at peak, if the trial works and works well, how many patients do you
think are actually could be on RITUXAN in kind of a peak normalized year?
Jim Mullen - Biogen Idec CEO, President
Hey, Mark, Ill take that because the answer is while we have, I think you well pointed out, its
fairly rough estimates of what the total patient numbers are available out there, which by our
experience is pretty typical in these marketplaces, particularly in something like lupus where the
line of exactly how theyre classified tends to move around a bit.
But the real answer comes with the data and how strong is the data, and how compelling is the data
and then all the other factors that surround that. But until weve really seen the data, anything
would just be a finger in the wind at this point.
So were anxious to see that data, be able to really analyze the data, understand subgroup
analysis, understand safety so remember, all were going to get on the first day is sort of
top-line stuff. And then youve got an ability to start taking it back out and talking to real
practitioners to understand what the real world relevance of the results are.
Mark Schoenebaum - Bear Stearns Analyst
And what kind of subgroups are you talking about?
Jim Mullen - Biogen Idec CEO, President
Well, it is a very heterogeneous disease by definition. So youre going to be looking at everything
from gender to age to prior treatments to organs involved, etc. So I think there will be a huge
treasure trove of data to go through which will help guide us where to go in the future.
Mark Schoenebaum - Bear Stearns Analyst
Okay, thanks. Good luck.
Operator
Yaron Werber, Citi.
Kareem De Felipe - Citi Analyst
Hi, this is actually [Kareem De Felipe] dialing in for Yaron. Thanks for taking my question. My
question is in terms of the strong AVONEX growth youve been seeing; can you perhaps give a little
more detail if its just a volume increase or just price increases? And how much room do you have
for more price increases both in AVONEX and TYSABRI? Thank you.
Paul Clancy - Biogen Idec CFO, EVP Finance
Yes, this is Paul. Ill try to take that. We certainly benefited from foreign exchange outside the
United States sales and then from the benefit of the price actions inside the U.S., the price
actions that were taken in full-year 2007. Nevertheless, I would characterize Q1 as very solid with
respect to our unit trends and, in fact, in both geographies we saw some of the best unit trends
that weve seen in a number of quarters. Which is testimony to, in the United States, some of the
new marketing programs that weve put in place are really taking hold as well as outside the United
States kind of continuing a very, very strong momentum.
With respect to forward-looking price, we really dont as a policy talk about that. And so Id kind
of probably just leave it there at that for now.
Kareem De Felipe - Citi Analyst
Okay, great. Thank you very much.
Operator
Joel Sendek, Lazard Capital Markets.
Joel Sendek - Lazard Capital Markets Analyst
Thanks a lot. Actually, I wanted to follow up on that last question and with regard to what you
said about unit trends. Can you help us understand if the instance of patients with MS is
increasing and maybe youre getting more patients off the sidelines in the TYSABRI into the
TYSABRI fold and maybe that could be increasing the potential patients on AVONEX as well even
though its kind of counterintuitive given the potential cannibalization?
Paul Clancy - Biogen Idec CFO, EVP Finance
Joel, I think that what were seeing in terms of unit trends outside the United States is actually
quite good. Inside the United States Id say that its probably characterized by slowing growth in
2008 as we saw in 2007. But the penetration in other geographies and just kind of expansion across
the world is actually beginning to help us.
We now with respect to disease-modifying therapies, there are actually now more patients across all
disease-modifying therapies on therapy outside the United States than inside the United States.
So I think its one of the things that weve tried to talk about over the last year or two is the
importance of the business outside the United States. And I think our strategy is really starting
to pay off as it relates to that.
Operator
Michael Aberman, Credit Suisse.
Elizabeth Woo - Biogen Idec VP of IR
Why dont we go to the next question?
Operator
Geoff Meacham, JPMorgan.
Elizabeth Woo - Biogen Idec VP of IR
Are we having technical difficulties, operator?
Michael Aberman - Credit Suisse Analyst
Yes, we are.
Jim Mullen - Biogen Idec CEO, President
Weve lost a queue or something?
Operator
One moment, sir.
Jim Mullen - Biogen Idec CEO, President
If we can reload those and start with Michael if we can find him again here and then go to Geoff.
Operator
One moment, please. Mr. Aberman, could you please press star 1 again? Okay, Mr. Aberman, your line
is open.
Michael Aberman - Credit Suisse Analyst
All right. Are you guys there? Fantastic. You had me in a panic. Looking at the trends for TYSABRI,
in the U.S. the actual number of patients added was flat compared to the fourth quarter whereas in
ex U.S. you had a significant increase. Going forward was there something unique about Europe in
terms of this quarter in terms of the rollout in countries where we think this might temper a
little bit going forward? Or should we think of this as a run rate in the U.S. based on this new
updated safety would you expect an inflection in the outer quarters or the next few quarters given
the recent safety update?
Bill Sibold - Biogen Idec SVP, U.S. Neurology Business Unit
So this is Bill. So internationally we did see the benefit of additional countries coming on board
and we expect that that effect will continue through the year and into the future. In the U.S. Q1
was what we had expected and we expect that there will be a steady growth in the number of new
patient adds which puts us on track overall for 2010 of our goal of 100,000 patients.
Paul Clancy - Biogen Idec CFO, EVP Finance
Hey Michael, this is Paul. Id just add and try to echo the fact that as weve articulated our
longer-term goals weve always thought about the contribution of TYSABRI in terms of patients to be
kind of in the 60% outside the U.S., 40% inside the U.S., and thats just based on kind of market
projections and planning. In the early read, based on Q4 and Q1 now, is that that assumption may
really start to be coming to fruition.
Michael Aberman - Credit Suisse Analyst
Thank you very much.
Jim Mullen - Biogen Idec CEO, President
Can we find Geoff Meacham again?
Operator
Geoff Meacham, JPMorgan.
Geoff Meacham - JPMorgan Analyst
Hey guys, can you hear me?
Jim Mullen - Biogen Idec CEO, President
We can, Geoff.
Geoff Meacham - JPMorgan Analyst
Okay, so to ask Michaels question a different way, I guess now that youre a few quarters in the
EU launch of TYSABRI is there any data you can give us on the source of patients? So basically the
EU version of slide 10 in your deck.
Jim Mullen - Biogen Idec CEO, President
The EU version of slide 10? Probably what Id say is it looks better outside the U.S. than inside
the U.S. in terms of the number of patients that are kind of new to the franchise. So few are
coming from AVONEX, more are coming from the competitors. And probably the return to the market is
about similar to what weve seen here. So where we say four out of five TYSABRI patients in the
U.S. are new to the Biogen Idec franchise, its probably closer to nine out of 10 outside the U.S.
And interesting, there are a couple of markets where TYSABRI is pretty quickly moving to the number
two position.
Geoff Meacham - JPMorgan Analyst
And just as a follow-up, do you see in Europe, any bias towards use of TYSABRI in first-line
patients in Europe?
Jim Mullen - Biogen Idec CEO, President
No, I dont know that weve seen a lot of change for physicians yet to initiate patient newly
diagnosed patients on TYSABRI. It happens in some circumstances but thats still a minority.
Operator
Eric Schmidt, Cowen & Co.
Eric Schmidt - Cowen & Co. Analyst
Congrats on the strong first quarter. My question has to do with the AAN meeting, maybe either for
Bill or Cecil. We noticed there were a couple of poster presentations at AAN that talked about
monitoring patients for JC virus reactivation. Im just kind of wondering what Biogens take would
be on some of that data.
Dr. Cecil Pickett - Biogen Idec President R&D
Yes, I guess youre specifically talking about the poster from Dr. Sadiqs study.
Eric Schmidt - Cowen & Co. Analyst
Thats right.
Dr. Cecil Pickett - Biogen Idec President R&D
Just to back up just for a second, just want to remind everyone, as of the end of March of 2008
there were approximately 26,000 patients on TYSABRI with no new cases of PML. Thats very
important. Dr. Sadiqs study identified two patients with JC virus, one in the blood and one in the
cerebral spinal fluid. I want to point out that these patients did not have PML and there is
actually no data that exists to suggest that they are at increased risk of developing PML. So we
believe the best approach to monitor for PML is through examination and clinical vigilance.
Operator
William Ho, Banc of America.
William Ho - Banc of America Analyst
Hey guys, congratulations on the quarter. I guess my question comes I guess with respect to your
current views of PML and the mechanism, given the FDAs recent advisories due to PML from Novartis
Myfortic and Roches CellCept, what are your future or your going-forward thoughts on the risk of
PML? Is it a TYSABRI-related event or is it just due to immunosuppression and do you see clinicians
becoming more comfortable with the use of TYSABRI?
Dr. Cecil Pickett - Biogen Idec President R&D
Well, I think what mycophenolic acid, which is CellCept its the ester of mycophenolic acid is
basically CellCept it inhibits sort of the key enzyme in purine metabolism. And because of that
it actually blocks proliferation both of T-cells and B-cells. So its a pretty powerful
immunosuppressant. So my take on that although the data is limited to date, but my take on that
is that any potent immunosuppressive agent may induce an increased risk of PML. And I think youve
heard from Bill that physicians are becoming much more comfortable with the benefit/risk profile of
TYSABRI.
Operator
Jim Birchenough, Lehman Brothers.
Jim Birchenough - Lehman Brothers Analyst
Hi, guys. Let me add my congratulations on the quarter. Just a question on the PLEX study results
and implications for the market. Maybe you could just comment on the number of infusion centers
that have apheresis capabilities and whether you think the data will give some comfort, not only
around PML, but for patients that might have to transition from TYSABRI to an immunosuppressive
quicker than the three-month lag time?
Dr. Cecil Pickett - Biogen Idec President R&D
Well again, I mean, the PLEX data basically suggested that three plasma exchanges actually reduces
TYSABRI levels quite significantly in the plasma. And the in vitro transmigration assay that was
done also suggests that with PLEX, with a plasma exchange, you can basically reconstitute the
immune system. So I guess we also have done some modeling which suggests that if you go out to five
cycles that you really significantly reduce TYSABRI levels to the extent I guess of greater than
95%.
Jim Birchenough - Lehman Brothers Analyst
I guess the question is in terms of practically are infusion centers in a position to plasma
pherese.
Bill Sibold - Biogen Idec SVP, U.S. Neurology Business Unit
Yes, we dont see that as being a barrier.
Operator
May-Kin Ho, Goldman Sachs.
May-Kin Ho - Goldman Sachs Analyst
Hi, I have a question on the Lupus study. If that study is negative what kind of sorry, what
kind of conclusion should we draw with respect to the upcoming trial for nephritis lupus
nephritis?
Dr. Cecil Pickett - Biogen Idec President R&D
Very difficult to say. I think many of us in this field for several years have thought that there
was a significant B-cell there is a significant B-cell involvement in Lupus. And so well get
the data and see what the data tells us about the Lupus study and sort of go from there. So I dont
think actually we completed enrollment in the lupus nephritis study also so well get data from
both of those studies. And we dont have to sort of guess, we can base our decisions on actual
data.
May-Kin Ho - Goldman Sachs Analyst
I was just really trying to refer to with SLE maybe you were less organ specific and with lupus
nephritis you are more selective there. So trying to figure out in terms of trial design or the
biology can one really extrapolate anything?
Dr. Cecil Pickett - Biogen Idec President R&D
I dont think so. I dont think so.
Operator
Bill Tanner, Leerink Swann.
Bill Tanner - Leerink Swann Analyst
Thanks for taking the question. A question for Bill Sibold maybe. Just as we thinking about
TYSABRI and looking at all the numbers that we have, obviously the ones that you guys provide, but
if we look at the numbers of patients per physician in the U.S., I guess the glass half-empty way
of looking at it is the growth really has come from new physician adds. The glass half-full I guess
would be that youve got perhaps physicians still dipping a toe in the water and youve actually
establish broader physician adoption.
So as you do the market research in understanding that two years is really epidemiological or
pathologically not a meaningful milestone, I mean do you get the sense that physicians are going to
begin to do more than just dip a toe in the water going forward?
Bill Sibold - Biogen Idec SVP, U.S. Neurology Business Unit
Yes, we believe that its not just the two years, but it is the release of utilization updates like
at AAN and other positive data as well as just the physician experience which is taking place. One
of the things that we are hearing from physicians is some very compelling results with the MS
patients that they treat.
So we really believe that with time, with the continued use of the product were hearing stories of
what other colleagues are doing, etc., that there will be a continued increase in the use of the
product from both a depth perspective, so the physicians that are currently writing, and also from
a breadth perspective that we expect additional neurologists will start to utilize TYSABRI.
Operator
Mike King, Rodman & Renshaw.
Mike King - Rodman & Renshaw Analyst
Thank you for taking my question and let me add my congratulations. Sorry to belabor the questions
on Lupus, but I was wondering I think one thing we could benefit from would be to understand how
the actual BILAG results are going to be presented to the Street. And perhaps again, without
trying to get the results from you, just how are they going to be represented? Will they be broken
down into the major and minor? Will we see one large number? Can you just give us some context of
how those results are going to be conveyed to investors?
Jim Mullen - Biogen Idec CEO, President
Well, I think what youre going to get so first, Genentech has been running the trial and our
experience working with Genentech is theyre very prompt at doing analysis and getting the top-line
results out, but thats really all youre going to get at the beginning because they will do a very
thorough but fairly quick review which means theres a lot of other thinking and analysis to be
done after that.
So I think youre going to get the top-line results did it meet the primary, didnt it meet the
primary and I dont know that it will be much more than that when we have it. I think the
details will follow as is the tradition for any of the companies, but especially Genentech and
Biogen Idec at appropriate scientific forum where theyll drill into the data and a fair bit of
detail with investigators.
Mike King - Rodman & Renshaw Analyst
Okay. But just to understand correctly, the primary is major and minor?
Elizabeth Woo - Biogen Idec VP of IR
Correct.
Jim Mullen - Biogen Idec CEO, President
Correct.
Elizabeth Woo - Biogen Idec VP of IR
Mike, thats correct.
Mike King - Rodman & Renshaw Analyst
Thank you.
Operator
Geoffrey Porges, Sanford Bernstein.
Unidentified Participant
Hi, its actually Isaac calling in for Geoff. Congratulations on the quarter again. I was hoping
you guys could provide a little bit more color on TYSABRI and Crohns disease. Both have the status
of a potential approval here in the EU, as well as some color on your conversations with physicians
ahead of the U.S. launch or following the U.S. launch, how you think the roughly 10,000 patients on
TYSABRI and MS is going to aid that and any safety concerns. And then finally, any assumptions you
guys have made for like TYSABRI uptake in Crohns for that 100,000 patients on TYSABRI by 2010?
Jim Mullen - Biogen Idec CEO, President
Okay, so its probably premature to raise the 100,000 number seeing as Ive spent the last nine
months or so getting people warmed up to the 100,000 number. But Ill be pleased to be accused of
sandbagging by the end of the year on the 100,000 number.
With respect to Crohns in the EU, just to take everybody back to what the issue there was, and I
think you properly put your finger on it it was the question of risk-benefit profile. And
certainly as we get more patients exposures in the EU, U.S. in MS but especially in Crohns, there
is just more real data to bring to that discussion.
So the plan right now is were re-engaging the EU regulatory authorities in that conversation. I
think its premature to say where thats going to go exactly and what theyre going to look for.
Hopefully within the next call or two here well be able to give you more specific guidance on
that.
With respect to the U.S. launch, what youre witnessing now is just what we witnessed at the launch
with MS. Theres a big educational phase in qualifying physicians. There has been a number of
scripts written, but I dont think theres anything you can conclude from the very early going. So
I think we just have to watch this evolve over the next couple of quarters. And Elan is leading the
commercial effort there, so they will be the company with a little bit more specific finger on the
pulse there as we roll forward.
Operator
Maged Shenouda, UBS.
Maged Shenouda - UBS Analyst
Hi, so my question has to do with RITUXAN and SLE. Genentech has been cautious with regard to the
ability to file for SLE with RITUXAN only with positive Explorer results, I was just wondering if
you share that caution. And then also, realistically, what labeled indication do you ultimately
anticipate for the product?
Jim Mullen - Biogen Idec CEO, President
Well, Ill take that one. What do we ultimately and with positive results in SLE positive
results in nephritis is a fairly broad label. Thats assuming a lot so I guess we have to see the
data. We know the first trial is it will be analyzed relatively soon; the second trial is fully
accrued I believe, isnt it? So well have those results in early 2009.
Its of course safe to say that the agency has become quite conservative. Thats not unique to this
particular product or Genentech or Biogen Idec. So has it been tougher to get things moved through
the FDA? Id say my perception is the answer to that is, yes. Having said that, youve got RITUXAN,
heres a product thats been out there for 10 years. Its been in the autoimmune setting for a
couple of years now with RA. So it does have a broad safety experience.
So I think some of the concerns that the FDA would typically bring to a review like this, our
answer given the huge database you now have of real-world experience. So with a positive outcome on
the data I think you can be optimistic that you can move that through. Will it require both trials?
I think you assume yes until you know otherwise.
Elizabeth Woo - Biogen Idec VP of IR
Operator, well take a couple more questions.
Operator
Adam Walsh, Jefferies & Co.
Adam Walsh - Jefferies & Co. Analyst
Hi, good morning. Jim, can you hear me, first of all?
Jim Mullen - Biogen Idec CEO, President
Yes.
Adam Walsh - Jefferies & Co. Analyst
Terrific. Jim, youve said in the past that we might expect to see additional PML cases with
TYSABRI and Im curious to know what your market research with neurologists has suggested that new
cases of PML, how they might impact prescribing behavior near-term and long-term and whether or not remind us whether or not your 100,000 patients on TYSABRI by year-end 2010 would include an
assumption of new cases?
Jim Mullen - Biogen Idec CEO, President
Good question. So I almost always get beat up by somebody whether its on a message board or some
place shortly after I make a statement that we should expect PML. But realistically what we have is
a black box warning. We have an educational program around this specifically and it would be just
irresponsible for me to say that otherwise and it would open up this company to an enormous
amount of litigation.
So until as the data continues to play out well see the statistics. But once you have that kind
of association on a label its going to be there. But what changes over time of course is the
perception of risk/benefit, and its not just the risk side of the equation which the data plays
out, but its the benefit, its what the physician actually sees in front of them in the clinical
experience over a number of patients over a significant sweep of time.
Now weve assumed in everything that weve done that we would see cases of PML. I think all of its
going to be fact and circumstances specific. If its one here, one there, what do you learn from
the cases? If its a cluster, what do you learn from those cases that you can then use to educate
physicians about the risk or how to monitor?
So weve assumed that we would continue to see some. Weve assumed though that the safety profile
will continue to unfold in a, if you will, somewhat more favorable than whats in the label, and I
think thats already probably statistically true today. But the label is the label until it gets
changed.
Elizabeth Woo - Biogen Idec VP of IR
Operator, well take one or two more.
Operator
Jason Zhang, BMO Capital.
Jason Zhang - BMO Capital Analyst
Yes, thanks for taking my question. I actually wanted to go back to slide number 10. You gave a
picture of TYSABRI users from three different sources. I assume thats a recent picture. If you
compared this to the very beginning, what would be the difference? Do you see the shape shifting
one way or another? Do you expect to see more of the patients switch from the other interferons and
Copaxone continue going into the future?
Bill Sibold - Biogen Idec SVP, U.S. Neurology Business Unit
So weve seen the this is Bill the shift that weve seen in time is perhaps more patients
coming from the AVCRs which we would expect, that as patients are in need of more efficacy that are
on current therapy that they will be switching to TYSABRI. And just the data, this is looking at
the end of March timeframe.
Jason Zhang - BMO Capital Analyst
And if you compare this slide, the pie chart to about a year ago what would be the breakdown?
Elizabeth Woo - Biogen Idec VP of IR
Not a huge change.
Jim Mullen - Biogen Idec CEO, President
Not a huge change.
Jason Zhang - BMO Capital Analyst
Not a huge difference?
Jim Mullen - Biogen Idec CEO, President
No.
Jason Zhang - BMO Capital Analyst
Okay. Thats very helpful. Thank you.
Elizabeth Woo - Biogen Idec VP of IR
Okay, well take our last question.
Operator
George Farmer, Wachovia Securities.
George Farmer - Wachovia Securities Analyst
Thanks for squeezing me in. Given I guess some of the concern about the presence of JC and BK virus
in CF, cerebrospinal fluid, and perhaps serum, is there in MS patients treated with TYSABRI, is
there any data out there that has looked at the normal levels of viral presence in healthy
individuals? Do you know how that could be compared to the MS situation, TYSABRI?
Dr. Cecil Pickett - Biogen Idec President R&D
Im not aware of any data.
Jim Mullen - Biogen Idec CEO, President
Boy, we havent looked at that for a few years. We extensively reviewed all of that information
that was available back at the time of the withdrawal and through that summer. I just dont
remember off the top of my head exactly what that data said. We also did a fairly extensive look
across some MS patients from data of a [Carolina] scan too, and theres nothing there to find. So
its a great answer. Well dig that out for you and try to give you some more specific references
to that. Maybe you can follow up with Elizabeth (multiple speakers).
George Farmer - Wachovia Securities Analyst
Yes, I havent seen anything; I was just wondering if you guys had any data on that.
Elizabeth Woo - Biogen Idec VP of IR
As Jim referred to, there was that study of the MS patients that were not pretreated and they
didnt see anything in the cerebral spinal fluid. And as we know, JC virus can be found in normal,
healthy, in the plasma but its not meaningful in terms of any predictive or diagnostic value.
George Farmer - Wachovia Securities Analyst
Great. Thank you very much.
Elizabeth Woo - Biogen Idec VP of IR
Thanks, everyone, for joining us on the call today.
Operator
Ladies and gentlemen, this concludes todays conference call. You may now disconnect.