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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
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INFORMATION REQUIRED IN PROXY STATEMENT
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Soliciting Material Pursuant to Rule 240.14a-12 |
ALKERMES, INC.
(Name of Registrant as Specified In Its Charter)
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This filing relates to a planned merger (Merger) between Alkermes, Inc. and the global drug
delivery technologies business of Elan (known as EDT) (such combination, the Business
Combination) pursuant to a Business Combination Agreement and Plan of Merger (the Business
Combination Agreement) by and among Elan Corporation, plc (Elan), a public limited company
incorporated in Ireland, Antler Science Two Limited, a private limited company incorporated in
Ireland, Elan Science Four Limited, a private limited company incorporated in Ireland, EDT Pharma
Holdings Limited, a private limited company incorporated in Ireland, EDT US Holdco, Inc., a
Delaware corporation, Antler Acquisition Corp., a Pennsylvania corporation and direct wholly owned
subsidiary of U.S. Holdco, and Alkermes, Inc., a Pennsylvania corporation. The businesses will be
combined under New Alkermes, a new holding company incorporated in Ireland that will be
re-registered as a public limited company, and renamed Alkermes, plc, at or prior to the completion
of the Business Combination. The Business Combination Agreement is on file with the Securities and
Exchange Commission as an exhibit to the Current Report on Form 8-K filed by Alkermes, Inc. on May
9, 2011.
The following is the transcript of an investor presentation made on May 10, 2011 at the Bank
Of America Merrill Lynch Healthcare Conference by Richard Pops,
Chairman of the Board, President and Chief
Executive Officer of Alkermes, Inc.
Forward Looking Statements
Information set forth herein contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, which involve a number of risks and uncertainties.
Alkermes cautions readers that any forward-looking information is not a guarantee of future
performance and that actual results could differ materially from those contained in the
forward-looking information. Such forward-looking statements include, but are not limited to,
statements about the benefits of the business combination transaction involving EDT and Alkermes,
including future financial and operating results, the combined companys plans, objectives,
expectations (financial or otherwise) and intentions and other statements that are not historical
facts.
The following factors, among others, could cause actual results to differ from those set forth in
the forward-looking statements: the ability to obtain regulatory approvals of the transaction on
the proposed terms and schedule; the failure of Alkermes stockholders to approve the transaction;
the outcome of pending or potential litigation or governmental investigations; the risk that the
businesses will not be integrated successfully or such integration may be more difficult,
time-consuming or costly than expected; uncertainty of the expected financial performance of
Alkermes plc following completion of the proposed transaction; Alkermes plcs ability to achieve
the cost savings and synergies contemplated by the proposed transaction within the expected time
frame; disruption from the proposed transaction making it more difficult to conduct business as
usual or maintain relationships with customers, employees or suppliers; and the calculations of,
and factors that may impact the calculations of, the acquisition price in connection with the
proposed merger and the allocation of such acquisition price to the net assets acquired in
accordance with applicable accounting rules and methodologies. Additional information and other
factors are contained in Alkermes filings with the Securities and Exchange Commission, including
Alkermes Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and other SEC filings, which
are available at the SECs web site http://www.sec.gov. Alkermes disclaims any obligation to update
and revise statements contained in these materials based on new information or otherwise.
Important Additional Information and Where to Find It
This communication does not constitute an offer to sell, or the solicitation of an offer to sell,
or the solicitation of an offer to subscribe for or buy, any securities nor shall there be any
sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under the securities laws of any such
jurisdiction.
In connection with the proposed merger, Alkermes plc will file with the SEC a registration
statement on Form S-4 that will include a preliminary prospectus regarding the proposed merger and
Alkermes will file with the SEC a proxy statement in respect of the proposed merger. After the
registration statement has been declared effective by the SEC, a definitive proxy
statement/prospectus will be mailed to Alkermes stockholders in connection with the proposed
merger. INVESTORS ARE URGED TO CAREFULLY READ THE PROXY
STATEMENT/PROSPECTUS (INCLUDING ALL
AMENDMENTS AND SUPPLEMENTS THERETO) AND OTHER DOCUMENTS RELATING TO THE MERGER FILED WITH THE SEC
WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ALKERMES, EDT AND THE PROPOSED
MERGER. You may obtain a copy of the registration statement and the proxy statement/prospectus
(when available) and other related documents filed by Alkermes and Elan with the SEC regarding the
proposed merger as well as other filings containing information about Alkermes, Elan and the
merger, free of charge, through the web site maintained by the SEC at www.sec.gov, by
directing a request to Alkermes Investor Relations department at Alkermes, Inc., 852 Winter
Street, Waltham, Massachusetts 02451, Attn: Investor Relations or to Alkermes Investor Relations
department at (781) 609-6000 or by email to financial@alkermes.com. Copies of the proxy
statement/prospectus and the filings with the SEC that will be incorporated by reference in the
proxy statement/prospectus can also be obtained, when available, without charge, from Alkermes
website at www.Alkermes.com under the heading Investor Relations and then under the heading SEC
Filings.
Participants in Solicitation
This communication is not a solicitation of a proxy from any Alkermes shareholder. Alkermes and its
directors, executive officers and certain other members of management and employees may, however,
be deemed to be participants in the solicitation of proxies in respect of the proposed merger.
Information regarding the persons who may, under the rules of the SEC, be considered participants
in the solicitation of proxies in respect of the proposed merger will be set forth in the
registration statement and the proxy statement/prospectus when it is filed with the SEC. You can
find information about Alkermes directors and executive officers in its definitive proxy
statements filed with the SEC on July 29, 2010. You can obtain free copies of these documents as
described above.
Final Transcript
Conference Call Transcript
ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
Event Date/Time: May 10, 2011 / 03:00PM GMT
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1
Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
CORPORATE PARTICIPANTS
Richard Pops
Alkermes Inc. CEO
CONFERENCE CALL PARTICIPANTS
Steve Byrne
BoA Merrill Lynch Analyst
PRESENTATION
Steve Byrne BoA Merrill Lynch Analyst
My name is Steve Byrne. I cover biotech stocks at BoA Merrill, and for me its a pleasure to
kick off this conference with Alkermes. Richard Pops took his role as keynote speaker very
seriously by inking a deal in Dublin yesterday so that he had a little more to talk about today.
So, Richard, CEO, its all yours.
Richard Pops Alkermes Inc. CEO
Thank you, Steve, and good morning, everybody. If I slur my words a little bit, its just
because weve been moving a lot over the last few days in a lot of different time zones.
First of all, I want to thank you for inviting us to the conference and doing such great work on
covering our Company. You guys are at the top of the heap.
What Ill do is Ill take you through a presentation relating to the transaction we announced
yesterday morning, but Ive been given the admonishment by our lawyers that I need to make both a
forward-looking statement, which is typical, about please refer to our Qs and Ks and the
description of the risks in our business, as we always ask you to do, in but now, theres a new
one because well be going into registration for this exciting new transaction that Ill tell you
about in a moment.
So this is a long piece of prose, and I was told that I should be wearing a sandwich board as I
walk around this conference with this on that talks about the fact that well be filing a proxy and
you should carefully read the Proxy Statement and the communications that we make today and the
communications that well make next week on our earnings call will all be governed by these proxies
or station requirements and other disclosure requirements. So, Ill ask you to please take those
seriously, as we will as well.
So with that, we had a call yesterday morning from Athlone, Ireland, which is in the middle of
Ireland. Its literally if you look at a map of Ireland, the center of Ireland is a place called
Athlone. And actually, the reason that Elan is called Elan because the middle four letters of the
word Ireland are Elan.
So, this is a company that Ive known for many, many years. We when we started out at Alkermes
building a drug delivery company based on advanced technologies, there were two models at the time.
One was [ALDA] and one was Elan, so I actually had an occasion to be in Athlone, Ireland, in the
90s and see the facility. And that was very much what we aspired.
It was a large-scale manufacturing facility, popped out of a big group of talented people making
drug product for pharmaceutical partners and for themselves for distribution around the world. It
was quite an inspiring place. So now, we find ourselves coming together with that company and, in
fact, creating a new company, which will be called Alkermes PLC.
And, as I said yesterday on the call, its a transformational deal. And, you know, people often
stand up when they talk about M&A transactions and say its a transformational deal. This one is
its literally transformational. We will transform ourselves into an Irish-based company thats
immediately profitable with over $450 million of top line revenues growing.
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May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
So, when we say in two domains, we think about the transformation. And one domain is financially,
and we put that first often for the people in investment communities because its a simple snapshot
to understand why its such an important deal from a financial point of view.
It creates immediate profitability in our business on a cash basis, and we see these adjusted
EBITDA margins growing and expanding over time, not based on cost-cutting or classical synergy type
things in M&A transactions, but driven by the fact that new products are coming into the market and
these new products are getting traction and theyre growing. And were going to grow along with it.
So, the growth of that is driven by this list of five commercial products that youll see in the
press release and Ill talk about in a second. Its a remarkable thing. Many biopharmaceutical
companies, their fate hinges on one or two products, and so we think its quite remarkable to have
a company with a commercial interest in five major, growing products with long-time lives.
And the patent lives on these products are not trivial. Many of them go into the mid and late 20s,
so theres plenty of time for the full commercial potential of these products to be realized. So,
this is why were so fundamentally confident about the basic financial hydraulics of the
transaction.
Moreover, with an Irish structure and not just an operating division in Ireland, but a legitimate
Irish company that leverages 40 years of operating history of Elan in Ireland, we have fairly
self-evident tax, financial, legal and other strategic advantages for being domiciled in Ireland.
So, thats going to be an exciting thing for us.
Then operationally, with the financial things (inaudible) what is thing going to look like, this
new entity weve created, the global biopharmaceutical company? And whats interesting is that both
of our companies are well known in the pharmaceutical industry for having developed innovative
products, brought them to market, run the regulatory traps and created real important products
based on really nice leading technologies. This isnt theoretical anymore. Weve done it, and I
think the probability of our doing again is quite high.
Interestingly, youre going to begin to see this company increasingly branded as a CNS company and
not CNS in the spectrum of neurodegeneration, new biological pathways place but in a CNS space that
big pharma is quite interested and we think is very, very well established.
These are in disease indications that we know well and that I think are quite tractable to new drug
development like schizophrenia, like depression, like impulse control disorders, like pain. This is
an area where we have a whole line litany of products and we have a really exciting pipeline
there.
Well have about 1,200 employees located in Ireland and in the US with the R&D expertise based here
primarily in the US out of our core in Waltham with manufacturing GMP world-class level in Athlone,
Ireland, our facility in Wilmington, Ohio, where we do injectable drugs, and in Gainseville,
Georgia, where they the Elan has another GMP manufacturing site.
So, its a really exciting company with a different scale, so its a its a financial shift and
its a transformational shift in terms of the scale, the reach and the ability for us to prosecute
the development of these products were so excited about.
So, it the basic motive force at the engine of this transaction are these five products. But,
whats so interesting to me about them is that many times in biotech M&A in particular youre
hoping and betting on favorable regulatory outcomes for the assets that you purchase.
In this case, these products, with the exception of BYDUREON, which we all know and we can talk
about a bit, these products were approved by the FDA and approved by European regulatory
authorities are on their way and, as I said, theyre at the beginning of their patent lives.
So, what are they? AMPYRA, AMPYRA is a drug thats sold by Acorda in the US, recently approved just
last year for the treatment of improving walking in patients with multiple sclerosis. This has had
a very rapid launch that many of you have watched. And it has patent protection into 2026.
Now Elan, their Early Drug Technology, EDT, actually developed AMPYRA and Acorda was their partner
who acquired the commercial rights to it. But, as a result, EDT and the Alkermes PLC retains a
tremendously advantageous stake in this. 18% of the top line sales will go to our Company.
VIVITROL, proprietary product, we take 100% of the top line in the US. This is our once-monthly
injectable medication for alcohol and now opioid dependence. Its something you the folks here
at BoA understand extremely well. You guys have done an enormous amount of work on this drug.
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May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
Its early in its life. Its going to grow. We have a lot to do, but its quite exciting and its
patented now until 2029. So, we have a fair amount of time and rather than take that much time
to develop the market for VIVITROL. But, we have an enormous amount of runway here.
BYDUREON, an 8% global worldwide royalty, this will be sold by Amylin and Lilly around the world.
You know much about it, the first once-weekly GLP-1 for the treatment of type 2 diabetes. This is a
game-changing medicine in the type 2 market.
We just recently received CHMP recommendation for approval in Europe, which should lead to approval
in the summertime, and we expect to refile in the US after completing the QT study in the second
half of this year. So, BYDUREON is on its way to entering the marketplace in what we think is an
exciting, expanding marketplace for GLP-1 treatment of type 2 patients around the world.
CONSTA, and the CONSTA pairing with SUSTENNA is one of the exciting things about this transaction.
CONSTA has been the economic foundation of our Company for a number of years. Its a $1.5 billion
drug. Its on patent through 2021. We receive a 10% manufacturing royalty on this, and thats 7.5%
net. Its been a fantastic product for us.
And the concern from some people in some course has been what happens if this new product, INVEGA
SUSTENNA, doesnt grow the market but is a zero sum proposition with RISPERDAL CONSTA around the
world.
Well, weve just solved this problem through this transaction because EDTs product, INVEGA
SUSTENNA, has essentially the same economics as our RISPERDAL CONSTA. And now we unite them under
one roof, were indifferent as whether RISPERDAL CONSTA or INVEGA SUSTENNA is the dominant
franchise in any particular market. We actually believe that the injectable, long-acting market is
going to continue to grow and lift all boats, but you wont have to worry about that any more.
There is if youre interested in playing the growth of the long acting market around the world,
we are the dominant player now in this space. And moreover and well get to in a little bit, we
have our own proprietary long-acting atypical antipsychotic in development now that we call ALKS
9070.
So, this is the line-up. And as I said, with the exception of some work that needs to be done for
BYDUREON in the US for getting approval and AMPYRA in the EU to get approval, these products are
commercial products. Theyre rolling. Theyre growing and theyre exciting.
And theyre going when you run the numbers on this commodity business, when you flow these
through the P&L that provides this really strong series of cash flows to build the business.
So, on top of that, you layer whats happening in our pipeline. Those of you who have been
following Alkermes for the last several years know that weve been really excited about pushing
this proprietary pipeline as aggressively as possible.
This is the next step in the evolution of the Company. Weve proved the validity of our
technologies through collaborations with pharmaceutical companies. Weve built factories. We get
products on the market. We get cash flows.
And we use those cash flows, rather than the equity markets, to then fund proprietary product
development to take the Company to the next level. These products are exciting, and weve picked up
a couple of exciting products from the EDT acquisition as well as well as the technology
foundation.
And, as I said, this CNS focus is quite distinctive and its, I think, quite attractive,
schizophrenia, depression, reward disorders, pain, opioid-induced constipation, multiple sclerosis.
So, I wont belabor these. We could take questions on these if youd like, but I would say the ones
to keep your eyes on thank you and as we come into the middle and the second half of this year,
ALKS 9070, long-acting, injectable form of Aripiprazole for the treatment of schizophrenia, in an
important Phase I/II study right now, which will define the pharmacokinetic profile of this drug
and its tolerability. With positive results here, and this is still blinded to us, we will move
aggressively into a pivotal program for that.
In depression were using our molecule ALKS 33, which is a very interesting oral compound derived
from our own chemistries, an opioid receptor modulator with potential uses across a spectrum of
diseases.
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Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
One of the more interesting ones is in combination with Buprenorphine for the treatment of
treatment-resistant depression. And well be in NDA with that this year.
In reward disorders, which is our grouping that includes alcohol dependence, opioid dependence,
binge eating and other types of impulse or reward disorders, we have an interesting line-up of
products that include ALKS 33 on a as a single agent and in combination with Buprenorphine and,
of course, VIVITROL.
Pain, pain weve been interested in in non-opioid type of pain approaches, given the prevalence of
opioid dependence and the need for non-opioid pain medicines. Through the EDT transaction, we bring
in a product from the threshold of Phase III called Meloxicam IV, which is an intravenous
formulation of a non-steroidal anti-inflammatory drug, which could be used in the hospital setting
to avoid the use of opioid narcotic painkillers.
OIC, opioid-induced constipation, ALKS 37, moving now into its broader pivotal program following
such exciting results in the Phase II that we talked about several months ago, this is an exciting
program. Were advancing this on our own, although theres great interest in this program from
other pharmaceutical companies. And wed be interested in partnering in certain domains on 37 as
well and, of course, AMPYRA in multiple sclerosis.
So, we like this transaction. We think what drives is the fact that EDT is just beginning a growth
cycle. Were beginning a growth cycle, and have these complementary technologies, manufacturing
plans. We have a very common philosophical approach to manufacturing drugs with respect to quality
and our interactions with regulatory agencies and our partners.
The CNS portfolio is going to become increasingly differentiated, I believe. The repatriation of
CONSTA and SUSTENNA under one roof we think is exciting and it just gives us, as I said, the scale
change to be able to have the ability to invest aggressively and as far as we want with the
pipeline projects that are of most interest to us.
EDT is a company that many of you dont know. Its a company that has was actually the
predecessor company to the Elan that many of you know today, which is more focused on bioneurology.
EDT was the original drug formulation and manufacturing business founded in Athlone, so its got
about a 40-year history and it had over 35 drugs approved. These folks are extremely competent at
developing these dosage forms.
They have a commercial portfolio of 22 marketed drugs, so you see cash flows thatll drive from a
whole history of legacy products, many of which in our modeling we didnt make grand assumptions
about their patent lives continuing or what. We just assumed that they would taper off naturally,
and thats why the emphasis on these five growth products for the combined company. But that said,
they do provide a flywheel of continuous cash flows that are incredibly important.
Their injectable NanoCrystal technology, which is the basis of SUSTENNA, which is a way of milling
products down molecules down to very, very fine nanoparticulates, which change their properties
in in vivo, both orally and injectably as injectables as well as their oral controlled-release
technologies are their technological foundation. And theyve got a history, as I said, of making
drugs all the way, not just partner drugs but drugs that theyve conceived of and developed
themselves.
And, as weve said many times, whats so interesting is when you look at these pie charts at how
you go from a company that has been so focused on revenues, in our case, from RISPERADOL CONSTA to
this pinwheel of diversification, which, by the way, creates the opportunity for such an aggressive
ability to borrow money to finance the transaction.
So, I wont bother you with all of the products, but the key takeaways that EDT within Elan was the
profitable piece of Elan with revenue of $274 million and adjusted EBITDA of over $100 million last
year. So, this is a proven economic engine that were fusing together with Alkermes.
The transaction terms, yes, youve seen from the disclosures yesterday, were providing $500
million of cash and 31.9 million shares of new Alkermes that will be issued when the transaction
changes closes. And its such an interesting environment for raising debt capital. Its a
positive incredibly positive environment for raising debt capital.
Because of the diversity of the cash flows, the long patent lives, the stability of the business
and the coverage ratios that youll see are quite modest in this transaction, acquiring financing
we think is going to be quite straightforward and we already have a backstop from Morgan Stanley
and HSBC.
5
Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
So, as I said, the financial impact, immediately accretive, profitable on a cash earnings basis
and, as I said, the coverage ratios are quite modest and well be able to pay down the debt, we
think, quite easily in a whole range of scenarios. We expect this transaction to close sometime in
the third quarter.
So, I think weve been through most of these things, this idea that the pro forma adjusted EBITDA
margin Jim talked about on the call yesterday, so even starting in 12, expecting to be in the
range of 15% to 20% and then expanding to over 30% as these products continue to grow.
So, as weve always done at Alkermes, were always going to be fairly fierce about managing our R&D
spend carefully to fund really those value-added programs that can drive to human proof of concept
and value deflection points quickly.
You wont see us expand our R&D efforts to become a more discovery-oriented company. No. Well keep
the discipline that we and EDT have had historically, and thats why we see the opportunity for the
margin expansion with the passage of time.
So, if a picture is worth 1,000 words, theres the pictures. The standalone basis on the revenue in
11 to what it looks on a pro forma combined basis. And on the right panel, of course, you see
Alkermes from losing money to having adjusted EBITDA significantly positive on a pro forma combined
basis for fiscal year 11.
And this is that pinwheel I was talking about. On the left is Alkermes on a standalone basis with a
huge amount of focus on the success of failure of RISPERADOL CONSTA over time, waiting for the
BYDUREON to begin to ramp, waiting for VIVITROL to begin to ramp, which we continue to be confident
about. But now, put it down on the right panel and you just see how much more rich and
uncomplicated and interesting the revenue mix is.
So, Ill finish there. And as I started off, I think its a truly transformational transaction from
a financial point of view and from an operational point of view. So, were going to work hard to
get the companies put together and get this closed up, and then we can actually begin to give you
even more specificity about what the combined business is going to look like.
So with that, Steve, Ill stop and Ill thank you.
Steve Byrne BoA Merrill Lynch Analyst
Okay. The floor is open for questions. Raise your hand and well get you a microcontroller.
QUESTION AND ANSWER
Unidentified Audience Member
I wanted to dig in a little bit more about the margin expansion in fiscal 2013. Is that more
revenue-driven or cost-driven?
Richard Pops Alkermes Inc. CEO
Its revenue-driven, because when you start looking at 13 you start seeing BYDUREON coming
on. Youre seeing VIVITROL beginning to go. Youve got AMPYRA growing. A lot of good things are
happening, particularly and add to that SUSTENNA in the EU as it starts to get its reimbursement
under it it should be growing as well.
Unidentified Audience Member
And can you comment on their view on AMPYRA? Given the first quarter revenue was kind of
flattish with fourth quarter, what is their outlook for the revenue forecast for that product?
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Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
Richard Pops Alkermes Inc. CEO
I think it they view it as a at a bit of a higher level rather than the
quarter-to-quarter swings. I think this most recent quarter for AMPYRA was expected, given the huge
number of patients who were put on originally with the pent-up demand. But first principles, this
product is going to guide to over $200 million in its first full year and its it has remarkable
benefit for patients.
So, in our modelling we view it we view it growing kind of consistent with many of the street
models but not at the far end of the street modelling range. And we actually took out EU revenues
just to be conservative, but we really do believe the drug will ultimately get approved in the EU
as well.
Unidentified Audience Member
Will they will the combined company have its own distribution channel?
Richard Pops Alkermes Inc. CEO
Its a good question. Right I think our ambition is with the scale that well have and the
global presence that well have we will seek to control more of the top line of our own products as
we move to this next stage of growth.
Now, with VIVITROL in the marketplace being sold by Alkermes we actually have quite a competent,
focused and, I think, interesting commercial group thats working on selling a product that quite
complicated as a specialty injectable and a new indication. Theyre really building a lot of
competence, so its a nucleus around which we could can grow.
And that said, we dont see moving from where we are today into global distribution in every
country. Thats why were still quite interested in partnering with large pharma, particularly to
build our own expertise in places where we might think to have a long-term presence. But, as a
general concept and as these companies get bigger and bigger, we want to control more and more of
our top line revenues. Dineen, up front here?
Steve Byrne BoA Merrill Lynch Analyst
Up here in front?
Unidentified Audience Member
Hi. Richard, can you talk a little bit about what you think the [exhumous] opportunity for
VIVITROL would be and given the agreement with Elan what you think the opportunity might be for you
guys to market VIVITROL through Alkermes as opposed to marketing it through a partner?
Richard Pops Alkermes Inc. CEO
Its a great question. Recall that VIVITROL is not approved anywhere outside the US other than
in Russia, and in Russia we think theres a real opportunity in the opioid-dependency indication as
well.
For alcohol, the regulatory environment in the various country jurisdictions was very, very
inconsistent where some countries were interested in abstinence as an endpoint. Other countries
were interested in harm reduction. There wasnt a common philosophical approach. So, we never
really pushed aggressively for pan European approvals in Europe.
Opioid dependence is different. Were sensing from governments a whole different view towards the
need for an antagonist therapy on the opioid-dependence side. So, that doesnt answer your
question.
Your question is are we going to sell it in Europe? Our belief today, and this is being refined as
we learn more and more, is that we probably wouldnt build individual country sales forces on our
own to sell only VIVITROL.
But, we are its exactly the kind of the product where we might collaborate and partner in a way
that would we could to build our infrastructure over time by collaborating with somebody OUS. So
thats where we stand on it right now, so stay tuned there.
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Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
Unidentified Audience Member
Does EDT have any sales force to speak of?
Richard Pops - Alkermes Inc. CEO
No. EDT has no commercial presence in theyve been really been focused on development and
manufacturing.
Unidentified Audience Member
Can you drill down a little bit more on the projected synergies at this point? Im sure its
just loading fruit, but do you see opportunities for either manufacturing synergies? Theres two
plants in the US. Or, is it more on the G&A side? Where do you see the synergy opportunity?
Richard Pops - Alkermes Inc. CEO
Its not hugely synergistic in that way, and thats why I said the synergy comes from the
expansion on the top line of bringing the products together. Whats interesting, because EDT
operates as a unit within Elan, as we buy EDT, merge with EDT, we dont bring along a lot of
redundant corporate overhead. So, that thats quite nice.
Because theyre based in Ireland and we have no presence in Ireland and because the GMP
manufacturing sight in Athlone is quite profitable and functional, theres really not much that
needs to be done. The plant in Gainseville is a GMP manufacturing facility as well, profitable,
making products.
We have they have a small R&D capability in King of Prussia, Pa. We have R&D in Waltham, and we
have our large manufacturing plant making injectable drugs like CONSTA and VIVITROL in Ohio.
So, well when we kind of look at synergies, we look at just jump ball in terms of the product
development programs themselves. We dont need to fund every product development program all the
way to Phase III ourselves. Well look at the best programs, rationalize them that way. But, on the
headcount side its it thats not what drives the deal.
Unidentified Audience Member
And does the ownership of both CONSTA and SUSTENNA change in any meaningful way your outlook
for the [deppa] formulations of ABILIFY and ZYPREXA? Or, were you is that that remain as much
of a focus target as it was before?
Richard Pops - Alkermes Inc. CEO
Absolutely, for the reasons mentioned before, we were obviously huge believers in the
medical value of these long-acting, atypical antipsychotics.
And the market share not withstanding the fact that data are published year after about better
outcomes, the market share for the long-acting injectables is still very small, on the order of 5%.
And already CONSTA is a $1.5 billion driving and SUSTENNA is growing, and its still a tiny bit of
a big market. So, we think that more entrants into the market will actually help expand the market.
And when you talk to physicians, the use of Paliperidone, the use of Resperidone, as long-acting
form in long-acting form makes sense. People are also looking for Aripiprazole, which satisfies
a slightly different place in the market as a very useful entrant as well.
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Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
And in that way, if we can capture the line, its a very concentrated marketing problem because we
know where CONSTA is being sold. We know where Paliperidone and [pompentate] are being sold. We
know the docs. We know the treatment centers that are using these.
The reimbursement is becoming more and more well established, so we just think its one of those
opportunities where a new entrant with a new molecule should be able to go into the slip stream of
a an expanding market.
Unidentified Audience Member
Can you talk about EDTs pipeline?
Richard Pops Alkermes Inc. CEO
Yes. One of the things we did, and we were talking about the messaging that we were going to
do around the transaction and theres so many things to talk about, we one of the things we
decided to do, well, lets not talk much about technology and pipelines because most people will
their cup will be full just understanding all the variables.
That said, we did highlight two for you to think about. One is Meloxicam IV, which is an EDT
developed product based on the nanoparticulate system, so its a way of formulating a non-steroidal
anti-inflammatory in an intravenous preparation.
And the Phase II data and well provide more of it to you over time after closing looks like it
could be opioid-sparing and very have a very useful role in algesia in the hospital setting.
The second one is a product thats being developed with Zogenix, which is another pain product. It
is in Phase III, and those Phase IIIs will be conducted this year with the expected filing of this
drug next year. Now thatll be a royalty manufacturing type relationship, but its a late-stage
product and it looks to be quite interesting.
I dont have a strong gut feel on that myself, getting to the announcement stage. I havent had the
chance to really tear into the actual data but, by closing, well have a much more refined view of
both of those products for you.
Unidentified Audience Member
(question inaudible microphone inaccessible)
Richard Pops Alkermes Inc. CEO
Yes, royalty, absolutely. I think Shane said on the call yesterday that theres, I dont know,
something on the order of 10 or so products that are cooking in various stages of development right
now.
But, in our modelling, we just didnt put those in because we just didnt have the need, given the
other major building blocks, to do diligence on each of those.
At some point, it becomes somewhat statistical. Its a portfolio that where technologies are
proven, various sponsors are developing, and well see which ones rise to the surface.
Unidentified Audience Member
The VIVITROL scripts in the US have really started to pick up in the last month. Can you
comment on the primary driver of that, whether its a particular end market or a particular
geographic region? And is it in line with your expectations?
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Final Transcript
May 10, 2011 / 03:00PM GMT, ALKS Alkermes Inc at Bank of America Merrill Lynch Health Care Conference
Richard Pops Alkermes Inc. CEO
VIVITROL is building. Its building, and I think its building in part because the awareness
is growing, both in alcohol and in opioid dependence. The new indication is obviously critical.
We had a major publication in Lancet last week, or 100 years ago it seems like, but it was last
week. The Phase III data were published in Lancet, and folks are beginning to get a sense that
VIVITROL is a new entrant.
Second, as you know, Steve, were getting a lot of interest from states and criminal justice that
are beginning to understand that theres a new antagonist-based treatment available and that
dovetails quite well with the goals of those types of systems.
But, we really are just now getting to the market with our new marketing material where, I think,
beginning in June is when well have our first slide decks available for peer-to-peer, for
doctor-to-doctor presentations.
So, in many ways, were just getting going. It takes so long to get market materials cleared
through DDMAC. So, I think the summer is going to be really exciting, and as we move into the end
of the year well have a real good sense of what that slope is going to be looking like.
Steve Byrne BoA Merrill Lynch Analyst
Great. Thank you, Richard.
Richard Pops Alkermes Inc. CEO
All right. Thanks, everybody.
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