defa14a
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
PROXY STATEMENT PURSUANT TO SECTION 14(a) OF
THE SECURITIES EXCHANGE ACT OF 1934
Filed by the Registrant þ
Filed by a Party other than the Registrant o
Check the appropriate box:
o |
|
Preliminary Proxy Statement |
|
o |
|
Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
|
o |
|
Definitive Proxy Statement |
|
o |
|
Definitive Additional Materials |
|
þ |
|
Soliciting Material Pursuant to § 240.14a-12 |
BIOGEN IDEC INC.
(Name of Registrant as Specified In Its Charter)
N.A.
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
þ |
|
No fee required. |
|
o |
|
Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. |
|
(1) |
|
Title of each class of securities to which transaction applies: |
|
|
|
|
|
|
|
(2) |
|
Aggregate number of securities to which transaction applies: |
|
|
|
|
|
|
|
(3) |
|
Per unit price or other underlying value of transaction
computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which
the filing fee is calculated and state how it was determined): |
|
|
|
|
|
|
|
(4) |
|
Proposed maximum aggregate value of transaction: |
|
|
|
|
|
|
|
(5) |
|
Total fee paid: |
|
|
|
|
|
o |
|
Fee paid previously with preliminary materials. |
|
o |
|
Check box if any part of the fee is offset as provided by Exchange Act
Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid
previously. Identify the previous filing by registration statement number,
or the Form or Schedule and the date of its filing. |
|
(1) |
|
Amount Previously Paid: |
|
|
|
|
|
|
|
(2) |
|
Form, Schedule or Registration Statement No.: |
|
|
|
|
|
|
|
(3) |
|
Filing Party: |
|
|
|
|
|
|
|
(4) |
|
Date Filed: |
|
|
|
|
|
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
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. Information concerning
the interests of participants in the solicitation of proxies will be included in any proxy
statement filed by Biogen Idec in connection with the Companys 2008 annual meeting of
stockholders. In addition, Biogen Idec files annual, quarterly and special reports with the
Securities and Exchange Commission (the SEC). The proxy statements and other reports, 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. Biogen Idec stockholders are advised to read carefully any proxy statement
filed in connection with the Companys 2008 annual meeting of stockholders when it becomes
available before making any voting or investment decision. The Companys proxy statement will also
be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142. In
addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree M&A
Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at info@innisfreema.com.
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
CORPORATE PARTICIPANTS
Jim Mullen
Biogen Idec CEO
CONFERENCE CALL PARTICIPANTS
Eric Schmidt
Cowen and Company Analyst
PRESENTATION
Eric Schmidt Cowen and Company Analyst
My name is Eric Schmidt. Im a member of the Cowen Biotech Research Team. Its my pleasure to
welcome everyone again back to the Cowen and Company 28th Annual Healthcare Conference and a
special welcome to Biogen Idec who I think has participated in a great majority of these conference
historically. Today were delighted to have with us the Companys Chief Executive Officer, Jim
Mullen. I see we also have Paul Clancy, the Companys Chief Financial Officer; Elizabeth Woo, Vice
President, Investor Relations; and Eric Hoffman, Director of Investor Relations. So we have the
whole Biotech the whole Cowen excuse me, the whole Biogen team here. And Jim says he should
have some time to take your questions both in this room and if we run over, upstairs in conference
room Provincetown, well be hosting a further breakout session. So, Jim, please?
Jim Mullen Biogen Idec CEO
Thank you very much, Eric. Good morning, everyone. Glad to see you here this morning. As
always, well start with the forward looking statements and of course we have a new addition to
this one, the proxy solicitation statement. Of course this presentation is going to include some
forward-looking statements including expectations about revenues, earnings, cash flow, progression
of pipeline, execution of our strategy. I think you guys all know that results could actually
differ fairly materially from what we either are hoping for or express today or imply. So I
encourage everybody to continue to go back to the securities filings.
Now the second part of this, as many of you probably know, we received a board of director
nomination and bylaw amendment proposal from a shareholder recently and as a result were obliged
among other things to inform you of such and to be sure shareholders have access to all the
information they might need around this process. So with that, let me get into the presentation. It
always feels like a downer to start with a forward-looking statement.
But this is probably the most exciting time for me having been associated with the Company now for
19 years. Ive never been in a position to have this kind of fundamental underpinning to the
business with also a great developing pipeline. So youll see that the three main products, AVONEX,
TYSABRI, and RITUXAN are all growing very nicely. Were coming off some very strong performance.
Weve now developed a pretty rich and late stage pipeline with 15 products in Phase II or beyond
and weve done that all with very, very good strategic with good, good financial results. I
think the strategy that we put in place a number of years ago has obviously been paying off. But
more important, I think this is going to continue to pay off as we work forward here into the
future.
So let me touch on sort of the underpinnings, the fundamentals. This purplish bar is the AVONEX
sales. You can see its been a nice progression since the merger in 04. Almost $1.9 billion. We
think that this product and this brand can still grow modestly, particularly as we continue to take
market share and increase penetration outside the U.S. and add new regions.
And as TYSABRI takes hold here, we do expect, and were very committed to maintaining our
competitive position in the ABCR market. RITUXAN, the $926 million you see there is our share of
the profit share. Weve got the enviable number one position in Non-Hodgkins Lymphoma but the
future growth story really is about the autoimmune indications. So a couple of years ago, we
launched in rheumatoid arthritis in the TNF inadequate responder segment. Earlier this year we
announced positive Phase III results in the DMARD inadequate responder
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
population. So well file for a label expansion along with our partner Genentech there. Were very
anxiously awaiting to get trial results on lupus and on the primary progressive MS trials which
Ill come back to in a moment.
And then lastly, you see the smaller blue bars on the bottom but growing very quickly and the
performance has been great on TYSABRI. You may remember that in the late third quarter last year,
September, I put out a goal, I said, I think we can get to 100,000 patients on product in MS and
Crohns Disease by the end of 2010. I would say that was received with some skepticism by the
investment community. But Im going to sort of take you through what underpins that because I think
youre going to see that we really are on track to do that.
So you may recall, we said 21,000 patients, we exited the year in December 31. And I want to give
you a few reference points. On the left are the number of patients on AVONEX treatment today in
just the MS alone. So on the bottom of that, thats the U.S. sales. The top is ex-U.S. sales. And
youll see its a little bit more in the U.S. than outside the U.S. Im going to come back to that
in a moment.
So if you just took the run rate of accrual of patients as we exited the year and just took that
linearly forward youd get to about 75,000 patients. Now weve been watching this market obviously
unfold for a while and in every market that weve been in, weve seen increased depth and breadth
of prescribing. As such, were seeing a gradual acceleration of the accrual rates in every market
that were in today. Were seeing a nice ramping of that and that was evident throughout all of
last year. So if this gradual acceleration continues, getting to the 100,000 mark is certainly well
within reach.
The other thing youll see is that we expect that theres going to be more sales outside the U.S.
than inside the U.S. and thats really driven from a couple reasons. The first is that were just
starting from a much stronger foundation internationally than we were in 1996 1997 when we were
launching AVONEX outside the U.S. Were direct in 25 countries outside the U.S. Thats a much
different position. The second is weve actually just got more patients to go after. And the third
is those markets are a little less penetrated than the U.S. marketplace. So we see the
international growing faster than the U.S. market and by 2010 it will be larger than the U.S.
market.
I think as we come through this year and if the safety profile continues to hold up particularly
favorable relative to the label, I think you may very well be saying, Jeez, Jim. I think you
underestimated the real potential for this product in MS and Crohns Disease. Ill be thrilled if
that happens.
Im very excited about the pipeline. This is really the first time where this year youre going to
start to see a lot of proof points over the pipeline. In 2004, 2005 after the merger we knew it.
You guys reported it. All the analysts knew it. We probably didnt have enough pipeline to reliably
grow this Company over the long-term. We spent a lot of time both accelerating internal development
but importantly, putting a lot of focus on business development. Weve brought in about ten
compounds, really through all stages of development.
So as we come into 2008 weve got four products in registrational trials, well have a fifth in
registrational trials by yearend. As evidence of how quickly this pipeline is maturing and the
large late stage trials, well have four times as many patients in clinical trials in 08 as 07
and thats a big step up over 06. As Ive said before, 15 programs in Phase II or beyond, I think
that is a nice, broad pipeline.
Weve got eight important data readouts coming here in 2008. Weve already reported out the first
one in the first half of the year. Theyre all RITUXAN just as it would happen to be and weve
already reported out the top line results for the Phase III DMARD inadequate responders. And so we
will apply for that label expansion with the FDA. The RITUXAN lupus, weve got a Phase II-III trial
in SLE. We also have a Phase III trial ongoing in lupus nephritis. That will report out next year.
And then of course the RITUXAN primary progressive MS. This is a pretty exciting area because
theres virtually nothing to help these patients in a pretty aggressive form of multiple sclerosis.
In the second half of the year, weve got a number of readouts. The BIIB14 program is a small
molecule orally available A2 antagonist for Parkinsons disease. So well see Phase IIa results
there. The HSP90, this is our lead oral program in the HSP90 area. We also have some backup
programs of that. And were in Phase I-II in GI stromal tumors. Were very excited about the HSP90
area in solid tumors and also potentially taking that into some other degenerative diseases.
The baminercept in RA and Im going to focus a little bit more attention on that in a couple of
slides. Well report out Phase IIb. We reported out IIa last year. RITUXAN in chronic lymphocytic
leukemia. That will be a Phase III trial in the second half of the year. Volociximab which is a
monoclonal antibody we have in partnership with PDL BioPharma we have in Phase II in ovarian. We
also have it in several other Phase I trials. And then a recombinant factor IX which weve just got
the IND approval for and moving forward on and Ill spend a minute on that program as well.
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
I want to highlight just a couple of programs that should give people a sense of really whats the
potential behind some of these products. So let me start with RITUXAN in lupus. The standard of
care today in lupus is not fabulous. Its steroids, immunosuppressants, chemotherapy, cellcep.
Theres really not been any significant advancements in decades there. Theres been 1.5 million
active SLE patients worldwide. A very big population, huge unmet need.
I think theres pretty strong evidence that the B cells implicated in the pathology of this
disease, that makes RITUXAN an ideal product here. RITUXAN of course has been on the market for ten
years. We know what the safety profile looks like. Its been in the RA market for a couple of
years. I think theres a comfort level with how to use this product at the rheumatologists office
and also with the safety profile. So weve got, as Ive said, a Phase II-III trial in SLE and a
Phase III in lupus nephritis.
If you look at the market size today, its a fairly small market. Its all generic products that
are going in there. We think with some advances with some reasonable amount of success this market
can grow pretty quickly. If you just think about a 10% penetration or something of that 1.5 million
patients, thats a $1 billion opportunity or greater for RITUXAN. So we think thats a big, big
opportunity.
Baminercept in Phase IIb rheumatoid arthritis. This is some exciting new biology and weve got a
great IP position and a great know-how position in this area. And were really excited about this,
not only in RA but in a lot of other diseases, lupus, Crohns, ulcerative colitis, MS,
transplantation, just to name a few. Now we started in rheumatoid arthritis for the same reason a
lot of people start in rheumatoid arthritis. First, theres still a lot of unmet need in this
market place particularly for a product with new biology. And then secondly, you know what the
clinical endpoints are. Theyre well understood. The regulators know them. You know what you need
to do and you can get the readouts relatively quickly before you move on to more complicated
diseases like lupus.
If you just take a look at those bar charts on the left, theres 1.5 million patients that have
DMARD therapy or TNF therapy and you can see in the blue portion, the majority of those patients
are really non-responders or inadequate responding. So the only way to get after these folks is
really to bring some new biology, a new product, new mode of action. Were pretty excited about
that. We saw the Phase IIa results in the middle of last year. We immediately accelerated this into
IIb and expanded the trials, one going after the DMARD segment, one going after the TNF segment. So
we do expect a Phase II readout for this in the second half of the year.
And then I just want to touch on the Factor IX program. This came in via our acquisition of
Syntonix. We have a Factor IX program. The INDs been approved. We have a Factor VIII program
behind this. We think this is a growing market but more importantly, theres a fairly significant
unmet need here for a longer acting Factor IX and Factor VIII to really get more into the
prophylaxis treatment. So thats the thesis that were pursuing. This has the advantage of you know
the target, you know what you have to do to hit the target. If you hit the target, the product
works, this is really a question of, can we hit this target, get the half-life that were looking
for and a safety profile thats acceptable. Relatively rapid trial, relatively small numbers. This
could get done, the Phase I-II in 08. It may tip over into 09. Just depends how the accruals run
out on this one. We think this is a big opportunity and this is hyperconcentrated market that does
not take a lot of commercial infrastructure to get after. And as I said, weve got a Factor VIII
program behind this one.
Not going to spend any real time on these. I can do it in questions and answer. But just to remind
you of some of the other late stage programs. BG12 is an oral, small molecule in MS. Its in Phase
III. We had completed trials in psoriasis. Those were successful but were actually weve
prioritized MS as the first trial. So this has been in a lot of patients over many years. Were
pretty excited about that program as potentially the first oral molecule in MS.
Galiximab which is a monoclonal antibody for Non-Hodgkins Lymphoma. This would be used in addition
to RITUXAN. So we think theres a opportunity to really increase impressively the response rates.
Lixivaptan, a program that we in-licensed. Its in Phase III for hyponatremia associated with
congestive heart failure. Lumiliximab, another monoclonal antibody out of our pipeline for CLL.
Thats in registration trials, the Phase I-II, impressive results. We saw a 52% response rate
versus the 25% of the typical standard of care and of course ADENTRI will enter Phase III trials in
the later part of this year in congestive heart failure.
This just gives you a quick snapshot of what the financial performance looked like. On the left,
you can see the performance of the shares against the BTK on a one year or four year view. I think
weve nicely outperformed the BTK in either one of those metrics. And then on the right hand side
you see revenue EPS growth.
When Bill Rastetter and I were putting together these two companies into one in 2003, we did
establish a number of goals, two of which were the financial goals and the goals were from 04
through 07, end of 07 that we felt we could get 15% top line growth and 20% bottom line growth. I
think we got very close to that, on the top line a little over 14% and we exceeded that a bit on
the bottom line. So I think weve had good financial performance and strong metrics here.
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
I want to change gears a little bit, elevate the discussion a little bit more to corporate strategy
and some of the challenges facing the industry and what are we doing as part of our strategy to
address some of those challenges. So, first Ill just focus on the left hand side, these global
industry challenges. We read it in the newspapers every day. Healthcare expenditures are going up
and up and up, pricing pressure is in the discussion in the U.S. every day.
The U.S. is really going to be the last place to arrive at real price pressure and price control
because thats whats really going on every place else in the world. Part of our advantage of
having a more global footprint is weve really learned how to address these issues and thrive and
know what the pressure points are but were going to have to address it. Its a challenge for
everybody in the industry. In the developed world youve got slowing economic growth. I dont think
thats any surprise to anybody. This was written, by the way, before this week. So it may be even
slower than we thought.
But youve also got slowing population growth in all of the developed world. Youve got population
growth 1%, 2%, 3%. Youve got slowing economic growth and then youve got demographic shifts which
are making the populations getting older and older and older. This is just going to put more
and more pressure on the healthcare system.
On the flipside, you do have a couple of rapidly emerging economies India, China, where the
wealth is increasing rapidly. Latin and South America. So being able to really approach the global
market, think about how to do global development and think about how to amortize and extract your
value from the product and build those values and amortize that over larger markets is critical.
R&D productivity, big problem for everybody. In spite of all the advances in biology, the fact is
the regulatory hurdles on efficacy, on safety, have been going up and up and up. The time to do
trials and the cost to do trials is going up and up. And I see nothing to abate that. Again, I
think this puts the emphasis on what can you do to maximize the value of the products you have,
good life cycle management, et cetera, and do you have access to all the important markets in the
world?
As we go into the next decade, we are going to start to see what, of course, big pharma saw in the
late 80s which is the entry of bio generics. It will probably be not quite the same version that
we saw with the small molecules but nevertheless, were going to have to figure out how we address
all those issues and, of course, we all have the challenge of attracting, retaining, cultivating
talent.
So what were doing and these are really not meant to be a one for one match up. But I touched
on a couple of these points already. Develop and commercialize blockbuster brands. Youve got to
take them globally. Youve got to make sure youve got aggressive lifecycle management. Youve got
to make sure that you take them in all the indications that really are valuable. So its not
development to some degree almost starts when you get your first approval for these products and
thats the mentality youve got to think about these products.
Were going to continue to expand our geographic reach. Were now direct in 25 countries outside
the U.S. Were direct in a couple of big markets in South America, Argentina, and Brazil. And weve
opened up in India and China. So were going to continue to aggressively expand our geographic
reach and weve done that with a very good formula which in almost every market weve gone into
weve been profitable in a very, very short period of time.
Advancing the pipeline, a challenge for everybody. In our case, weve got a great pipeline now.
This is really an execution challenge. Those are the kind of challenges you like to have. There is
a lot of competition out there for clinical trial patients so youve got to be creative on where
you do your trials and how you conduct them. But this is really an execution problem.
The next point really is different. Accelerating innovation internally and externally. Thats a
culture problem. Thats a question of how do you keep the innovation and productivity of these
smaller companies as you advance and become a larger company. And weve approached this from a
couple of different ways. One is how weve organized ourselves. We organize these things in teams
that are big enough to really have all the expertise but small enough to really keep the passion
around the products and to give you a more vertical structure around getting from development,
discovery, into development and through into commercialization.
And second is the venture investing strategy that weve had. We put in place venture investing four
years ago. It gives us the front seat in a lot of companies. But importantly, the different thing
that we did is we integrated it very closely with our R&D organization. So weve got scientists in
the R&D organization championing these deals and following these deals. Its not just a financial
instrument because in the end were interested in products and technology. Its also led to a
couple of significant acquisitions, Conforma being one and Syntonix being the other, that if we
were not in that network we probably would not have seen those opportunities.
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
And then lastly, we saw a gap in the funding ability of the venture capitalists on bringing some
great projects out of academia and financing them initially. The venture capitalists have gone a
little bit later. Theres been a gap there. So we tried a new approach with this incubator
strategy. So where we fund some projects coming out of academia, we bring those scientists with
them, we have some product right, we surround it with a little bit of infrastructure and then leave
them off to do the science with some specific milestones attached. So were going to try a number
of these experiments. I dont know which ones are going to work. But were going to try to be
creative. But it does create a mindset of continuous innovation internally.
Weve had a great position in biologics for years. We continue to have great biology in the
discovery labs and that goes right through our ability to attract compounds in on business
development because we know how to develop them, get them to the regulators, and we also know how
to manufacture them at high quality in large quantities. And of course the strong financial
performance, the impact of that on stock price is obvious but maybe whats less obvious is that
were in an enviable position because we are in a position to really look at opportunities and take
advantage of those opportunities as they may appear in the marketplace, particularly interesting
when you go through a lot of stress in the marketplace as we as the biotechs have been through
and are likely to go through.
Now, execution of strategy is not a straight line and I want to just touch on this slide because it
draws out a couple thing on strategy for us. When Bill Rastetter and I were looking at the two
companies going back to 2003, 2002, one of the challenges you had was did you have enough pipeline,
did you have enough resources that you could reliably continue to bring products to the market and
grow the Company. That was a big challenge that we both had. What we spotted was an opportunity to
really put two companies together where we could make use of capabilities that already existed in
the other company and then reallocate resources and capital to the pipeline. Alright? Thats really
the essence of the merger and the thinking.
Shortly after that we really got down to it with the board and we worked through the strategy and
we realized that we could develop a pipeline quick enough just on internal developments. We were
going to have to be aggressive and competitive on BD. And we made sure we had the room in the
financial structure, in the capital structure, and in the P&L to be able to do that and we went off
and did that.
Along the way we had all the excitement, TYSABRI launching, it was going to the moon. And
unfortunately in early 2005 we had the big disappointment and we had to retrench. And we focused on
that question. This is the second product this is only the second product thats ever been
brought to the market and I think it will be the first one that gets back to blockbuster status. I
think were well on our way.
Along the way, weve continually asked the question, what are we doing? How is it going to create
value? And if were doing something and you cant answer the question of how its going to create
value in the future, irrespective if it created value in the past, then it needs to be divested,
shut down, or those resources refocused. You can see sort of along the top line, weve sold hard
assets, weve sold product assets, weve restructured the work force. And weve done that on a
pretty continuous basis.
As we got back into TYSABRI comes back to the market and it became a little clearer where we
were going with that, I started to focus on a little bit longer term strategic plan for the
Company. I touched on a little bit of that in the prior slide. Im not going to get into that
today. But we are thinking long-term, thats why were doing venture investing. Thats why were
doing incubators and those kind thats why were expanding geographically. Last year, we did a
$3 billion share repurchase. We werent excited about assets that we could buy out there. We
decided our stock was the better value. We did that very quickly, in 30 days, we repurchased $3
billion worth of shares.
And as you know, with all the excitement around the MedImmune acquisition by AstraZeneca earlier in
the year, there was enthusiasm among investors that this was going to be the time when big pharma
started to go after the more developed biotech assets. We tested that thesis late in the year and
at least for now, thats not going to be the case. But we remain open to every way to think about
how do we really create shareholder value as we go forward here.
So Im going to finish up. I think weve got a very strong investment thesis. Weve got great
fundamentals. Weve got strong growth across all these products, strong growth across every region
of our business. Weve got a rich pipeline. And this is going to be the year this is really the
first year where the investment communitys really going to get a lot of data about this pipeline
and were all going to know how much value is sitting in that pipeline and thats going to unfold
over the course of the next nine months and it will continue to unfold as we go into 09, 10. And
I think we have demonstrated weve got a proven strategy to deliver financial results in good times
and bad. Our 08 guidance is 15% to 20% top line, 17% to 20% bottom line and we think we can
continue that kind of performance through that 2010 timeframe as we move into 09, 10, youre
going to see the pipeline, were going to see the pipeline, and we can all sort of set the
trajectory beyond that.
So, with that, do we have time to take a few questions right now? Yes? Great. Im going to repeat
the questions because it is a webcast. And then were going to more upstairs, later.
Final Transcript
Mar. 18. 2008 / 11:00AM ET, BIIB Biogen Idec Inc. at Cowen and Company Health Care Conference
QUESTION AND ANSWER
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. The question is biosimilars that could affect the AVONEX franchise. Let me split it into
two parts of the world or three parts of the world.
Europe, where right now, the next product to come on the market isnt truly in the category of a
biosimilar. Theres some patents that protect that for a little bit of time as well as our product
and thats the old bio-partners product. And so that will come, probably not super competitive
initially because thats really the low dose, Rebif strategy. So theyre going to have to do a
little bit more to expand that. You probably will see a second brand, Betaseron coming out of
Novartis. Unclear precisely what their strategy is but I would say
thats prepared for FTY 720,
down the road is to get their feet into the MS market.
In the U.S., the legislation is not in place. My guess is it might get in place in 09, 10. As a
practical matter, the patents go out into the early part of the next decade, 13 or 14 depending
on how you read them.
Outside of those two areas there are a few biosimilars that have been in the marketplaces in Mexico
and Cuba and Iran. There are a few places like that. Theyve really had not a significant impact on
the business and theyve been out there for a few years. Okay? Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
The question is around Copaxones high dose study and if it were to show superior efficacy.
Well, if it shows superior efficacy to Copaxone, the low dose, of course thats going to be an
important marketing tool for Copaxone. They are a very strong marketing company and we assume
theyre going to continue to be strong in the future. You cant take it away from them. Theyve
done a good job developing products.
But those are all products that are still sort of back in the interferon-like efficacy. TYSABRI, if
it continues to hold up, youve got a completely different efficacy profile and as people get more
and more comfortable with the safety profile and as we get thousands of patients beyond the two
year point and people can get more comfortable, I think that really becomes the efficacy part to
shoot at.
The next thing to look at is really going to be the oral molecule, things that bring a whole new
convenience. BG12 I think is in that category. FTY could be there. And we also have a Phase II
compound, CDP 323 which is on the same pathway as TYSABRI. So thats where I really think the
future is going. I think that could give them a nice life in the interim. But thats not ultimately
the strong competitive position. Yes?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Final Transcript
Yes. Great question. The question is around PML and what happens when we see PML cases. Its
always hard to sort of take yourself back in time but you almost have to see the situation at the
moment that it occurred. We had no signals in 3,000 plus patients. At that point we had never seen
a PML event in the MS sector in AVONEX which weve been in for eight years at that point in time.
And you get two reports in a day. We just launched the product and you had a huge queue of people
behind that. That was in the backdrop of the exact time when Vioxx and hearings on the Hill were
all in high relief. So I think there was a whole combination of events that come together that
cause you to pull back and you say, Okay, weve got to really study this product.
Now we studied that product and we studied that issue and we determined, in fact, there were three
cases. We knew of two. The third one was actually in Crohns setting, actually much earlier that
had been misdiagnosed I think three or four different times.
So thats the background. We now understood at least the outlines of the safety issue. The experts
recommended against concomitant administration of interferons or any immunosuppressive with TYSABRI
so thats the way its come back into the marketplace. Importantly, you know, its sitting there
with a warning label and I think thats important. We have now advised everybody that this is a
potential. So its in every piece of communication. Its in
every conversation. And the TOUCH
program in the U.S. which is the risk management program, literally we have dose by dose
understanding and review of every one of these patients.
So if it is to reemerge, its in a very different category. First, its in the label. Everybody
understands it. Were now past 21,000 patients. Weve seen none. I think the question that remains
out there is there perhaps some association with time on product and increasing risk. Thats why in
some peoples minds the two year time point becomes important. But I think a case or two or
whatever, as long as its within the label is really not, from a regulatory point of view, a reason
that this product would come off the marketplace. It will have an impact in the investment
community and it may have a temporary impact in the market.
I think there was how are we doing? A few minutes? Okay. Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Well, I wish I remembered. The question was would sales of TYSABRI equal sales of Betaseron by
end of 08? First, Im not sure I remember doing that but thats not that strange that I dont
remember something. Thats why weve got an Alzheimers program that we just started. Boy. I dont
look. Heres what I can say because I dont remember the exact Betaseron numbers off the top of
my head. I think were going to have, as we exit this year, to get on this 100,000 plan, were
going to be at $1 billion plus run rate. So I feel like thats pretty much in reach. I dont
remember precisely what the Betaseron sales levels are at this point but its probably its
still north of $1 billion.
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. Well, the 20% of the market actually equates to this 100,000 patients is about 20% of
that market at that point in time. So thats probably more what were talking about.
Okay. Im getting the cut off signal from Eric. So were going to go where? Upstairs?
Provincetown? And we can continue. Thank you very much.
Final Transcript
Breakout Session
CORPORATE PARTICIPANTS
Jim Mullen
Biogen Idec CEO
PRESENTATION
Jim Mullen Biogen Idec CEO
Theres a great warning up here which probably more politicians need to read. It says,
Beware. Microphones are live at all times. Questions and answers. This is webcast as well so bear
with me because Ill be paraphrasing and repeating questions again. I know that can be a little
annoying for you guys in the audience but I want people on the webcast to be able to hear the
question.
Okay. We can do that.
That wasnt a question, right?
Jim Mullen Biogen Idec CEO
Okay. Now were in front of the curtain, not behind it. Just for the people listening. Okay.
Questions? Ive got Paul here. Eric? Yes?
QUESTION AND ANSWER
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. You know, when we got into the difficulties a couple years ago, I spent time with Art
Levinson and we both felt important that we try to isolate the debate which was turning into
arbitration and Ill come back to what that is and isolate that from whats going on in the
commercial realm. I think the performance in the commercial realm has continued to be positive and
productive and this has had a minimal amount of impact at the operating level.
The debate is really about decision making rights. And certainly Genentech has a different
interpretation of the contract than we have on that. Given that this relationship is going to go on
forever, we think its important that we get a final reading on what those decision rights are. I
also know that theres been some speculation that theres a bunch of downside in this for us but
this is really about decision making rights. Theyve chosen to move forward with all these other
programs anyway so theres really nothing thats slowed down from a development point of view that
Im aware of and we continue to progress in those different programs clinically. So if anything we
may have a little bit of upside to this if it gets resolved in our favor. At worst, we get clarity
on the decision making rights going forward and then what weve agreed is, look, whatever that
decision is is how were all going to behave from that moment on. If its if the Genentech
interpretation is right, okay. And if our interpretation is right, then the relationship will
change a little bit.
Final Transcript
But theres every one of these partnerships is going to have a few of these little bumps in the
road because theyre two different companies, two different objectives, and theres always a little
bit of misalignment and its always hard, in my experience, to predict exactly how one phrase in a
contract actually turns out in reality. So yes?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. What the decision making I mean, the first of the decision making rights and we feel
we have a little more influence on that than they believe and we wouldve made some slightly
different choices in some of these development programs. The overriding principle of this contract
is maximize on collaboration profit which so taken literally, which is exactly how we do, I
dont sit here and go, How do I ? Its how do we optimize the CD20 franchise across all those
products.
A specific example which is not in our particularly in our corporate interest but I thought was
in the interest of the collaboration and the patients is pursuing relapsing, remitting MS with
RITUXAN. They terminated those trials in Phase II and decided to skip forward to the next compound.
They had an idea that that could be done in an accelerated fashion. The we did not believe that
was going to be true and the FDA has not agreed with them either. And by terminating that trial,
thats cost a few years in the development of RITUXAN in relapsing remitting MS, for example. Yes?
Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Okay. So to repeat it for the people on the webcast, theres really two sets of comments. One
is about the usability of the website with AVONEX or TYSABRI and then the second part of it is
really around TYSABRI and why is the website filled with warnings and discouragements if I can put
it that way? Is that a fair characterization?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Lets address on the website side, we periodically get some feedback on that. Id say by
and large I mostly dont get complaints about that or customer service which, of course, if you
call our customer service, youll get a live person unlike if you called AT&T or somebody. So
youll get live people that manage the cases and often know the patients by name. That tends to be
a better avenue for patients. Ill take the feedback and well take a look at that. Im in contact
with those folks.
The second part, which is TYSABRI, the fact is we have a very regulated set of distribution and
everything we put up there or everything we put out, whether its in print or on a website is
reviewed, approved, and regulated by the FDA. And given its history, thats all youre going to see
pretty much are the warnings. Its unfortunately that I heard and Ive got piles of letters.
Weve got piles of anecdotes and youve recited many of them. I think thats probably the most
exciting thing about TYSABRI is not only what people report about the disease and how they feel but
people that are reporting that they can now do things that they couldnt do before. Unfortunately,
were not able to use any of that from a promotional point of view. Third parties are free to use
it but we cannot, given the regulations. Its a little discouraging to patients. That I can
appreciate. But thats the answer. Thats where we are with the FDA regulations. Yes, sir?
Final Transcript
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. The question is about our partnership that goes across three antibodies with PDLI. Were
very excited about a couple of those programs. One, of course, we mutually agreed to terminate
probably a year ago. That was the HuZAF RA program. I understand theres actually some third party
interest in that program and so were working closely with PDLI to see if thats real because if
thats true, that asset should go forward in somebody elses hand. The Volociximab program were
excited about. Its in a few different Phase Is in solid tumors. Obviously were in the Phase II in
ovarian. That would be an exciting outcome. And then the third one is
the Daclizumab program which
was weve seen Phase II results as combination therapy with AVONEX. Were now in a Phase II
trial to establish monotherapy efficacy as the approach going into Phase III with those programs.
In terms of changing the relationship, we made some minor changes. Theres certainly been a lot of
discussion as theyve gone through their difficulties and so weve tried to work with them in a
close partnership to make sure that these programs continue to advance forward. Obviously those are
critical programs to them. On a relative basis, more critical than they are to us. But theyre
important programs to us. We are doing all the manufacturing and a lot of the heavy lifting on
Volociximab and Daclizumab at this point even though Daclizumab was being manufactured by them.
Weve changed some bits of the relationship. Weve really not changed the economics to any
significant degree but of course were open to that. But were not necessarily pressing for that.
Yes?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. So this is a question on the 2010 goal, 100,000 patients around TYSABRI. So I think the
first thing is it is 2010. And I didnt select that I selected that because thats sort of the
time horizon to see really where the rest of the pipeline and the typical time horizon the analyst
has worked on is three years. Now most of the new competitors, competitive products, whether they
be ours or others really come into the scene after that timeframe. Ive seen a lot of programs
about to blow us up in MS and, you know, over ten years I guess Ive become a little bit jaded on
that and Id like to actually see the final data before I conclude how terrible its going to be.
But in terms of the assumptions behind the 100,000, its really just its fairly straight
forward. We need to see continued depth and breadth of prescribing. We are expecting, we continue
to warn people, were anticipating there will be some cases of PML. Well see how that safety
profile really unfolds as we go through this year and we see a significant number of patients that
are on therapy for 18 months or two years. I think thats sort of the remaining large safety
questions that physicians and patients can sort of better understand really what the incidence is.
What weve seen is certainly a shift in the psychology in the marketplace where initially when we
went back out they were reserving patients that had failed everything else that were fairly late
stage. Those are the patients we sort of call the train wrecks. Those are also the patients we
wouldve thought might be at higher risk of PML given their exposure to immunosuppressants over
long periods of time. But thats all theoretical. We are seeing people move it forward in the
treatment regimen and in some countries, Germany being one, for example, theres a fair amount of
initiation of therapy on TYSABRI. More so than we see in some of the other markets.
So specifically what were expecting is we watch the weekly accrual rates in the U.S. and outside
the U.S. Those have accelerated fairly steadily over the past year. And were assuming that will
continue to accelerate as we see more prescribers which were seeing and more depth and really its
the patients psychology. And you heard the anecdotes from the gentlemen a few rows back. We hear
those everywhere we go and we hear them by the dozens. Thats really what goes around the patient
community and when the physicians see in front of them what I call the two dimensional data that we
send out and New England Journal of Medicine articles or whatever turn into people with real
clinical response, the whole mindset around a risk benefit starts to shift.
Final Transcript
So we are expecting that were going to see PML. Thats what weve continued to warn against. No
doubt because of the history of this product, that will cause a lot of excitement in the short
term. I think it really is what are the circumstances around the cases and how many are there over
what period of time. Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Yes. If we get a couple of cases of PML, its what do you learn from those cases? One of the
objectives theres a couple objectives for the risk management program thats been installed in
the U.S. Number one is to ensure that only patients that are appropriate to receive therapy receive
therapy. Second is that these patients are fairly closely monitored. So every time the go in for an
infusion, they actually get a questionnaire from the healthcare provider. Have they seen any
changes in symptoms and whatever? And if the answer to any of those boxes is yes they get
recycled back to the treating neurologist.
And so a lot of it and so the second is to have a very high quality database on whos received
product, whats their medical history, what other products have they been on, how long have they
been on the product, how many infusions have they gotten, and then what do you learn from the cases
you get? It would the wisdom of the experts was avoid patients that are immunosuppressed and
avoid giving patients concomitant therapy concomitant immunosuppressants.
Thats what weve been doing. Does that hold up over time and what do we learn about the specific
cases? But for a few cases that are within the incident rate thats in the label, I see no
particular regulatory issues. I see a lot of investment concern and I think well get a reaction to
that in the investment community. And I think it may take a couple weeks or a month or two for the
prescribing community to digest whatever information we learn from that. But a few that are within
the label, both in the U.S. and Europe and I dont think that poses any particular regulatory
problem. Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
This is about our Alzheimers disease program. We actually have a few different programs in
Alzheimers disease, most of which we havent really spent a lot of time discussing externally. The
one we have talked about is in licensing that we did in the fourth quarter with Neurimmune. And so
this is an antibody approach but I think the different piece of this is its an auto-antibody so
its coming out of patients that have had positive responses or positive evolution if you will of
the disease of Alzheimers. Theres a couple of other technical hooks which Im not qualified to
even talk about.
We also have some more standard programs like gamma-secretase modulators and things like that. So
were obviously interested broadly in neurodegenerative diseases. Id say as the HSP-90 field moves
forward, were pretty excited about that as a potential as well because these misfolded proteins
and chaperoning were always thought to be part of the mechanism there. So we think there may be a
way to cross over the HSP-90s into Parkinsons and Alzheimers. But thats a little ways off still.
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen - Biogen Idec CEO
Final Transcript
So the question is on TYSABRI. Will we see an inflection point because people starting now
really can see the results for people that have been on it for a year or two years in front of them
and therefore have the ability if theres events to change their medication, if you will, before
the risk goes up?
Ive heard that theory out there a few times. Actually recently Ive heard it. We thats not a
marketing message that we can be going out and talking about. But thats the kind of thing that
will get driven through the opinion leaders in the medical community. I dont know that I hear that
among those folks. But the logic is interesting. Ive heard that logic actually several times just
in the last couple weeks. I hadnt heard it being discussed before that. Maybe people are thinking
about that.
What we can say is the psychology as the months go on, as the numbers go up of patients and as the
cases are treated in front of the physicians eyes, thats why were seeing this gradual
acceleration of accruals. Is there a magic inflection point? Were not assuming there is one. It
could happen though. Well all know it looking in the rearview mirror probably. I dont think
theres a magic switch out there. But thats when youre going to be accusing me of being just low
balling the 100,000 patients. Which would be great because everybodys laughing at me three months
ago. So Id love to be wrong, on the high side. Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
The question is isnt it a high probability that the risk of PML goes up with time? I think
the answer is nobody really knows that. I think thats kind of the last theory that can be out
there. But theres no real mechanistic or scientific basis
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
As I said, its the only one thats left out there but I wouldnt say that theres any
underpinning scientifically. Importantly, because I want to point people over to the other thing;
we havent been just sitting on our hands around PML. We have been looking at risk mitigation.
Weve done flex studies which is to get TYSABRI rapidly off board. We have screened lots of
different compounds to see what compounds might have efficacy against J.C. virus. There are some
hits of approved drugs. So were actually going to do some work in the clinic in the HIV patients
with those populations. So were actually looking at it a number of different ways. Can we predict
it? Can we know whos at risk? Can we do something about it if we saw it to address those? I think
any or all of those together also help I think mitigate the risk in reality and particularly in the
minds of treating physicians. Yes, sir?
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
So the assertion is that theres no history of PML in monotherapy. If you only looked at the
two patients with MS, your statements are true but unfortunately there was a third patient which
indeed was actually chronologically the first patient which was in Crohns disease. And theyd
actually been they were on monotherapy. They had a long, long history of immunosuppression but
they were not on concomitant immunosuppressants at that time.
Unidentified Audience Member
Final Transcript
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Alright. This is the situation were often in in the drug development business which is
proving something is never going to occur, never happen, is an almost impossible task. So were
associated with what were associated with. I think by and large the medical community understands
that and thats certainly where we try to talk about that.
Unidentified Audience Member
(Inaudible question microphone inaccessible)
Jim Mullen Biogen Idec CEO
Those kinds of conversations can occur between medical professionals and medical professionals
in our Company. They cannot happen at the sales force level because its just illegal. Its just
that happens to be the fact. It arguably isnt true, either, depending on how broadly you want to
draw the definition.
Believe me, wed love to be out there more aggressively doing this. What we have done here has been
taking a very careful approach, a very responsible approach, and we have the trust of the
regulators, the physicians, and the patients. I think that is very important to how we continue to
move this business forward, that they feel like theyve got the full safety update. Thats probably
the most critical thing that they look for and that were going to be as conservative as they are.
I think that has, more than any other thing, helped us bring this product and get it back to where
it is.
Any other questions? I think thats it. Thank you very much. Appreciate your time.