defa14a
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
(Rule 14a-101)
INFORMATION REQUIRED IN PROXY STATEMENT
SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE
SECURITIES
EXCHANGE ACT OF 1934 (Amendment No. )
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 § Rule 14a-12
ALKERMES, INC.
(Name of Registrant as Specified In Its Charter)
(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: |
|
|
|
|
NOT APPLICABLE |
|
|
(2) |
|
Aggregate number of securities to which transaction applies: |
|
|
|
|
NOT APPLICABLE |
|
|
(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): |
|
|
|
|
NOT APPLICABLE |
|
|
(4) |
|
Proposed maximum aggregate value of transaction: |
|
|
|
|
NOT APPLICABLE |
|
|
(5) |
|
Total fee paid: |
|
|
|
|
NOT APPLICABLE |
o Fee paid previously with preliminary materials:
NOT APPLICABLE
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: |
|
|
|
|
NOT APPLICABLE |
|
|
(2) |
|
Form, Schedule or Registration Statement No.: |
|
|
|
|
NOT APPLICABLE |
|
|
(3) |
|
Filing Party: |
|
|
|
|
NOT APPLICABLE |
|
|
(4) |
|
Date Filed: |
|
|
|
|
NOT APPLICABLE |
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 24, 2011 at the UBS Global
Specialty Pharmaceuticals Conference by James Frates, Senior Vice President, Chief Financial
Officer and Treasurer 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, Inc. 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, Inc.s 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, Inc.s filings with the Securities and Exchange
Commission, including Alkermes, Inc.s 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, Inc.
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, Inc. 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, Inc.s 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, Inc.s Investor Relations department at Alkermes,
Inc., 852 Winter Street, Waltham, Massachusetts 02451, Attn: Investor Relations or to Alkermes,
Inc.s 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, Inc.s 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, Inc. shareholder. Alkermes,
Inc. 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, Inc.s 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 UBS Global Specialty Pharmaceuticals Conference
Event Date/Time: May 24, 2011 / 10:00AM GMT
1
THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us
© 2011 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by
framing or similar means, is prohibited without the prior written consent of Thomson Reuters. Thomson Reuters and the
Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. |
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
CORPORATE PARTICIPANTS
James Frates
Alkermes, Inc. CFO
PRESENTATION
James Frates Alkermes, Inc. CFO
Thank you. Good morning, everybody. Its nice to be here in London. Its actually sunnier here
than it is in Boston; weve had two straight weeks of rain, so but we wouldnt know it because
weve been on the road quite a bit.
And as you know, two weeks ago on Monday we announced a very exciting deal, we think, with our
merger with Elan Delivery Technologies, the drug delivery business from Elan. And Id be happy to
take you through that this morning and then take some time for questions.
Lets see. So, I will make forward-looking statements this morning. Its awfully hard to talk about
a biotechnology or pharmaceutical company and not make forward-looking statements, but I would
direct you to our SEC filings for disclosures about our risks and a full description of our
business.
And I would also say that were as we would be filing a merger document, an S4, and a proxy
statement with the SEC, that this is not an offer to sell securities or solicitation of an offer to
sell, but that certainly you should review the proxy statement when theyre filed in the next few
weeks around the transaction.
So, with that out of the way, Id like to tell you a little bit about what we thought was so
compelling about this transaction, because both from an operational perspective and from a
financial perspective we think the deal is actually quite transformative for Alkermes.
So finally, as you know, Alkermes is a Company that was investing in our R&D pipeline and in a
controlled way we used about $5 million or $6 million in operations last year. You should remember
that were in a March fiscal end, too, so we just finished fiscal year 11 March 31 and were now
in the beginning of fiscal year 12, in our first quarter fiscal year 12. Im sorry to say we will
be keeping a fiscal year end March 30. Its just much easier from a transaction perspective.
But this deal will make us immediately accretive in cash earnings. Elan generated about $100
million in EBITDA last year, and so that combination going forward will be very important for us.
In many ways, financially thats all we need to say because that growth is going to continue over
time.
But more importantly, too, we also think that with five key products that Ill touch on a minute
with long patent lives, that this really creates a very unique opportunity as a pharmaceutical
Company with financially growing revenues. Were thinking single-digit growth for pro forma fiscal
year 12 and then accelerating to double-digit growth as we have some new product launches coming
and, more importantly, expanding our EBITDA margin, which we think is really attractive. Again,
more on that later.
Operationally, weve turned ourselves into a global biopharmaceutical Company. Alkermes previously
has had operations in Waltham, Massachusetts, where we do R&D, and Wilmington, Ohio, where we do
manufacturing. And Elan, as you know, EDT, has a very large manufacturing facility in Athlone,
Ireland and a large manufacturing facility in Gainesville, Georgia. So its going to be turning us
into a worldwide Company.
Were going to have a deep expertise in CNS products, and thats going to be very interesting as we
move forward and look at commercializing some of our own products over time. Well not only be able
to diversify our revenue streams from day one with a lot of royalties, but it will build out our
commercial infrastructure.
As you know, we sell VIVITROL in the United States for the treatment of opioid dependence and
alcohol dependence. And as we build out that operational infrastructure, we have the benefit of
diversifying our revenues, but in any area of CNS that we know very well. So were not looking
2
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
at device companies or generic companies or cardiovascular companies; were going to be in our home
in CNS, which we think is a hallmark of very successful deal.
And then finally, well have 1,200 employees around the world with R&D experience and manufacturing
experience, and we think our management team is quite capable of running the Company. Important to
note, all the senior managers from EDT are coming with the business.
So we were able to carve out exactly the business that we wanted to purchase. It was very similar
in many ways, and so that business we had a square hole and we carved out a square peg to fit
right in that square hole. So we dont have a lot of synergies in terms of layoff or things like
that. The businesses are really very complementary, which were quite excited about.
So, with five major products, and with even recently had some good news that we did not anticipate
with AMPYRA, starting at the top of the alphabet with the recommendation for approval in Europe
last Friday from the CHMP. So that was not something we had anticipated when we looked at this
transaction, but were very excited about it. Certainly, we didnt anticipate it in the near-term;
we anticipated it over a much longer term.
So, thats a very interesting view because, as you probably remember, Elan actually developed the
product initially. And then in the earlier phase in their life, out-licensed it to Acorda and then
Acorda out-licensed it to Biogen Idec, which is obviously a very experience partner in MS around
the world.
So its been a great launch. EDT receives an 18% royalty in manufacturing mix, so a very hefty
chunk of the profits from the launch of AMPYRA. And we think with the patent term extension that
theyve received in the United States and the ten years of exclusivity thats coming in Europe, the
long patent life and the high royalties are going to be something thats very exciting.
VIVITROL. Thats a proprietary product, developed at Alkermes, recently approved last fall for the
treatment of opioid dependence. Been over a lot of slides in this step. Weve talked about it a lot
before. Opioid dependence, and particularly the abuse of prescription opiates, is a major problem
in the United States and around the world.
In the United States, we have roughly 300 million people. There are 260 million prescriptions for
opiates written every year in the United States. Its a major problem. The addiction to these
painkillers has been a major problem, and theres really no treatment that is not an opiate.
Theres substitution therapy with Suboxone and Methadone.
But VIVITROL, a monthly antagonist, is really a very unique treatment. Were getting a fantastic
response by the medical community, by the national governments, by the state governments. Its
going to take some time to change the way people treat opiate dependence. Its a very difficult
disease, but we think that VIVITROL has a lot of legs. And we recently actually received a patent
extension through 2029. So that, again, is a product that will be protected and is controlled 100%
by Alkermes. So were excited about that.
BYDUREON. Also, recently some very good news as we received recommendation for approval in Europe
for this very important GLP-1 antagonist. I dont think that you can underestimate the power of a
weekly dose, a weekly GLP-1 antagonist for the treatment of diabetes.
The medication leads an important class. Its just in its beginnings. The other competitors,
several by Novo Nordisk, is in its second year and will a several billion dollar plus drug thats a
daily injection. And I think the difference between once-a-day injection and once-a-week injection
is very, very important if youre a type II diabetic. So were very excited that get that product
to the marketplace.
As you know, weve had two now reviews by the FDA that have resulted in complete response letters.
Amylin and Lilly are running that QT study right now and the goal is to file in the United States
in the second half of this year. And again, we should be receiving approval in the next month or
two in Europe and be able to launch in Europe in the second half of the year.
The other thing that we like about this deal is that its a pure royalty for us. So, 8% of net
sales around the world will be coming straight to our bottom line. Well be profitable on this
product from the first vial sold, and well also receive two milestone payments upon first launch
in Europe. Well receive a $7 million milestone payment in first launch in the United States;
again, another $7 million milestone payment. So this is a very important drug for us economically.
RISPERDAL CONSTA, a drug you probably know well, sort of around the world, its J&Js third largest
pharmaceutical product, $1.5 billion in sales. Its growth is actually starting to accelerate
again. We will receive a 10% royalty for RISPERDAL CONSTA and its been the key driver of our
revenues. In fact, last year it provided about 84% of our revenue.
3
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
One of the things people were very worried about is the only competitor that seems to be on the
horizon is a drug called INVEGA SUSTENNA, also made by J&J and based on the nanoparticular
technology of EDT. So this deal actually repatriates both the CONSTA and the SUSTENNA revenue under
the roof the royalties under the roof of Alkermes.
The SUSTENNA royalty is between 5% and 9%, with escalating sales. And again, is a pure royalty for
EDT; J&J manufactures this. So while the cost to J&J is the same, the goal is to really expand the
use of long-acting therapies.
And for schizophrenia, honestly, theres a third competitor on the market and theres some older
generic long-acting preps. But if you know someone with schizophrenia, the medical outcomes are
very, very clear. They ought to be on a long-acting prep.
They have much lower rates of relapse, they do much better longer term, and, in fact, the largest
place where RISPERDAL CONSTA the highest penetration around the world is here in Europe, where
the single payors, who can see the whole benefit and cost of the healthcare system, have adopted
it. And RISPERDAL CONSTA has roughly a 16% market share in the five largest countries; only has a
4% or 5% market share in the United States.
So were still [learning] to grow with these long-acting preps. And one of the competitive threats
that people worried about with Alkermes, i.e. why is J&J developing both these long-acting drugs,
whats in their mind, gosh, were worried that RISPERDAL CONSTA might not have that growth
continue. Weve seen that growth, again, as I said, in the last two quarters start to reaccelerate
again in the United States.
INVEGA SUSTENNA just received approval and was launched earlier this year in Europe, and so were
quite excited, again, have these unified under one roof. And the patents for RISPERDAL CONSTA and
INVEGA SUSTENNA SUSTENNA goes to 2019; CONSTA goes to 2020 and 2021 in Europe.
So again, five products, major diseases, major economic opportunities for Alkermes, and theyre all
under one roof. We think that diversification of revenue clearly in the life cycle of all of these
products is really quite unique.
We talked a little bit about AMPYRA. As you know, its to improve walking in MS patients. So it
doesnt treat the disease itself, but the symptoms of the disease. Its going to expand our scope.
Again, the 18% royalty is very attractive for us. A long patent life, and you can see let me see
if theres a . You can see here that sales really, there was an amazing amount of pent-up
demand.
And as Acorda has said in their recent conference call, were beginning to see in these patients
it works not in every patient, but in those it works on, theyre beginning to see an acceleration
of the overall script trends, even as they fulfill the pent-up demand for launch. So with the
launch coming in Europe and the extended patent life in the United States, were quite excited
about the opportunity for AMPYRA.
With VIVITROL, were beginning to see an acceleration in sales. We grew sales on an operational
basis 43% year-over-year in our last fiscal year. The launch in opiates has gone well, but is
really in the very beginning stages. Really, in the month of June well have full materials that
have been approved by DDMAC and out in the field. Its taken us this long to get that approval of
the marketing materials.
And so as our field force its a small group, about 60 people in the United States. But as they
call on their physicians, now really just this month and next, we will be able to have the full
marketing materials and discussions. And also, theres also an additional slide deck thats been
approved so peer-to-peer education can go on. Physicians can now talk about the product through an
approved slide deck.
We think those things are going to be important. Weve had good reception from the payors. Weve
had good reception from the states, and were beginning to work some of the states and federal
governments in the criminal justice system as well.
So that hasnt impacted sales yet, but were beginning to interface with them. As you can imagine,
a number of folks unfortunately, in the United States we incarcerate more people than any place
in the world, and a large percentage of those 40% in the state of Massachusetts alone are
there associated with drug problems.
So whats the first thing a drug addict does when they get out of jail? They go seek drugs again.
So we think theres a real opportunity with VIVITROL to use medication and the monthly injection
that is an antagonist. And were beginning to do some pilot programs with various states. So again,
thats going to take some time to unfold, but were quite excited about the potential trajectory
that VIVITROL has and sadly, a very big market for opiate dependence.
4
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
Weve talked about BYDUREON. [BYDUREONs] last 12-month sales of over $500 million.
Importantly, though, that market now has expanded to over $1 billion in sales around the world.
[Victroza] is off to a very good launch. BYETTA seems to be, in fact, holding its own. And we think
the weekly product is going to be a very, very nice alternative.
Indeed, we talked about the submission timeline in the US, submitting in the second half, patent
coverage to 2025. And interestingly, theres going to be a number of improvements as time goes by.
Not only easier methods of use, so a dual chamber syringe, potentially a follow-on product where
the product that wont have to be reconstituted, and ultimately a monthly product that Amylin has
completed Phase II testing on and later this year will be moving forward with a monthly.
So, a very exciting project; we think theres opportunities there for many years to come with
BYDUREON, and approval recommendation here in Europe was obviously very important from a regulatory
perspective.
RISPERDAL CONSTA. We touched on that, the long patent life. And really, the key message Id like to
leave you with is that that very narrow penetration of the long-acting in schizophrenia. So in
Europe its doing better. Its recently launched in Japan and its already up to a 6% market share
in Japan after about two years of sales.
And in the United States, again, slower adoption, mainly because each state Medicaid this is a
disease thats mainly treated by Medicaid so each state, often each individual county, makes
choices often driven by budget. And in a disjoined system where pharmacy managers are choosing,
rather than overall people with overall control of the total costs, not just the pharmacy costs,
that continues to be a battle.
J&J is starting to see growth. And along with INVEGA SUSTENNA, J&Js business of schizophrenia now
really is about increasing the penetration of the long-acting preps, having them used sooner and
sooner, so maybe even as first-line therapy as opposed to last-line therapy. Okay, Ive tried the
orals. Now Ill try the long-acting prep. Its actually much better medicine to use the long-acting
prep first, and thats been shown in a number of clinical studies.
So the exciting thing is having those together under one roof at Alkermes, the opportunity to take
advantage of both with the new Alkermes PLC, offsets a number of concerns people had about the
future of RISPERDAL CONSTA we believe unfounded, but there we are.
So, the other thing is in CNS we actually have a very attractive pipeline. So as weve outlined for
a number of years now, weve always tried to build the Company for growing top line, for growing
bottom line, but in the end the premium value Company will also have an exciting pipeline, and we
think we have one in CNS.
This just talks about some of the areas were working in. Schizophrenia we have a follow-on
compound, a long-acting form of Abilify, 90-70. This is a proprietary molecule for Alkermes using
our LinkeRx technology. Its currently in the Phase IIa study; well have results on by the end of
June.
And were quite excited about that because a single dose should cover the patient for a month, and
what were asking, really, is to define that PK profile. Can we do it consistently? Can we do it
without injection site reaction? Can we deliver the appropriate amount of Aripiprazole? Because
what we dont have to answer is whether Aripiprazole treats schizophrenia.
So, if we can share that monthly release of Aripiprazole, were quite excited and I think we can
invest in it with a great deal of confidence, and that will create a very important market
opportunity for us. So, exciting news awaiting us in June for that.
In reward disorders and depression, were working on a very interesting opiate antagonist, a new
antagonist that weve developed in our own laboratory, a new [NCE] called ALKS-33. Weve studied it
in alcohol dependence and seen very, very good results.
But now, were trying to broaden it out into binge eating, again, where people eat because of
psychological reward as opposed to satiety. And in the DSM-V criteria, its been proposed as the
third eating disorder. So it is a recognizable and diagnosable disorder. So were in a Phase II
study in binge eating.
Were also in a Phase II study were going to start, excuse me, in the second half of the year,
we a Phase II study, interestingly, in combination with Buprenorphine. So this is an opiate agonist
Buprenorphine and an antagonist 33 on the new receptor of the opiates. And what it leaves is
a kappa agonist, which is an area that people have been very excited about.
5
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
You can read [quota] literature, actually, on the morphine treatment for depression. The reason,
though, opiates arent used to treat depression is because theyre so addictive. So whenever I come
to London, Im a big Arthur Conan Doyle fan. Sherlock Holmes in the old days used to treat with
depression by smoking opium, okay? So, this treatment for depression has been around for a very,
very long time.
If we can knock out the addictive new receptor and leave the kappa agonist, were quite excited
about treatment resistant depression and will be studying 33 in combination with Buprenorphine in
that.
We also have a study that combination was actually funded by NIDA because they wanted to look at
cocaine. So theyre doing a Phase II study and have had positive results in Phase I. Another study
in cocaine is going to be getting started there in the next few months. So, in reward disorders, a
lot going on with 33.
In pain, two EDT compounds, actually. One in Phase III [ZX002] with Zogenix, which is
currently in its second Phase III. This is a hydrocodone without acetaminophen, so it wont have
those liver concerns that people have in the hospital, a very nice prep.
And then, Melixicam IV has just finished its second Phase II. Again, this is a compound controlled
entirely by EDT, developed internally. And the goal here would be to get an end state with fast
onset of action and 24-hour coverage to be used in the hospital setting. Again, opiate staring, a
thing that we know a thing or two about and it fits right in with our concern about the overuse of
opiate pain relievers.
ALKS-37 for opiate-induced constipation. Again, as the proliferation of these 260 million
prescriptions for opiate pain relief, roughly 50% of the patients on an opiate get debilitating
constipation because the gut is lined with opiate receptors. When the antagonist hits those, the
gut motility just shuts down and it can be quite debilitating.
So, weve had positive results on 37 and well be moving aggressively into later-stage development
there with a broader dose ranging study in preparation for Phase III, thats going on. And then we
talked about AMPYRA and expanding AMPYRA around the world.
So, it was a very interesting strategic fit for us. It positions us for growth with the launch of
AMPYRA in its early stage, with the launch of SUSTENNA in its early stage, and anticipate of the
launch of BYDUREON. All three of these are going to drive expanding margins, we believe, on a very,
very nice top line and bottom line. Complementary delivery formulation and manufacturing
technologies that we have, and a CNS-focused portfolio that I just went through, and the capability
to invest prudently with a larger base, but also with the ability to drive EBITDA.
Again, weve never been at Alkermes nor EDT, frankly, a heavy R&D-focused organization. You wont
come and find buildings filled with scientists. In fact, at Alkermes fully 50% of our R&D is
externally spent on clinical studies, third-party manufacturing, things like that to drive growth.
So were not investing in lots of basic, high risk research, which is great if thats what you do.
But were focused on developing products, and we think we are focused in doing that and were very
happy with that.
So, EDT has an established model of profitability that were going to but it is those cash flows
over the years have been taken by Elan to invest in their higher risk neuroscience portfolio, the
bioneurology portfolio so Tysabri, Bapi, etc., Alzheimers disease. Were going to try and
deliver more of those revenues to the bottom line into profits, so were very excited about that
and that diversified revenue stream should really help us do that.
You can see some of the products that EDT has. This is their calendar 10 $270 million in revenues
and $100 million in EBITDA, a broad range of products some are on patent, some are coming off
patent. But as we have the growth, that was the exciting thing that we saw, the beginning of
another phase of growth for EDT, which fit very nicely into what we were doing.
So, just quickly on the transaction. Youve probably seen this by now, but I would be amiss if I
didnt talk about it. $500 million in cash. Well be borrowing roughly $400 million, essentially
using the EDT cash flow to support that debt. Its very appropriately sized for us and were quite
happy with that.
Because, at the end of the day, what we would have paid for this business is 31.9 million shares,
or 25% of our equity, and the interest on that debt because we see the ability to pay that debt
back in the next four or five years if things turn out as they seem. So we think thats a
reasonable purchase price for us.
The pro forma Company should be immediately profitable on a cash earnings basis. And were
committed to paying down the debt and expanding our EBITDA, not through synergies, but again, with
the launch of these products and the growth and profitability we think thats very important.
6
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
So, we need a shareholder vote on the Alkermes side to close the transaction; thats why I
mentioned well be filing a proxy statement probably in the mid to late June timeframe. And theres
customary closing conditions with Hart-Scott-Rodino and antitrust filings, but we dont believe
that there are any issues there. And the deal is expected to close in the third quarter of the
calendar year.
This picture says a thousand words because we go from revenues of under $200 million to roughly
$450 million, and from a loss position to a profitability position. So, we like that slide very
much.
I dont want to skip over this, though, because we have committed on our conference call to
double-digit growth rates in revenues after fiscal year 13 and beyond, and we think that EBITDA
margin should be in the range of 15% to 20% pro forma, just putting the companies together for the
full fiscal year 12, and expanding to 30% to 35% range in fiscal year 13 and beyond.
Theres some synergies, but again, thats really on the R&D side. As we put both companies
together, all of the spending isnt really required, so we can focus in on our main products and
save roughly $20 million in that area.
So, again, another picture. We like to see this as the revenue concentration that we have with
RISPERDAL CONSTA and VIVITROL and a little bit of pre-BYDUREON sales for polymer. But as we look,
RISPERDAL CONSTA concentration goes from 83% to 34% or 35%, as I mentioned.
So, again, financially and operationally we think the deal makes sense. And I forgot to mention
that actually as part of the transaction we will actually be ultimately domiciled in Ireland. So
the new Company, Alkermes, PLC, will be domiciled in Dublin. Ill have an office there. The senior
management team will have offices there. And were quite excited to have a European base and be
much closer to you all, so we can get here to the city and start to build as many relationships on
this side of the Atlantic as we have in New York with our investors there.
So with that, this little yellow light is blinking at me. I hope I didnt repeat myself too much
after the red-eye last night, but if you have any questions Id be happy to entertain them in the
two or three minutes that we have. Im sorry. Any questions? Yes.
QUESTION AND ANSWER
Unidentified Audience Member
How does the Ireland location change your tax structure going forward?
James Frates - Alkermes, Inc. CFO
Yes. So, the question is about the Ireland location and our tax structure. What weve told
people to do is model the revenues that come from Ireland, or that are domiciled in Ireland, are
taxed at a 12.5% Irish tax rate. Those that are domiciled in the US are taxed the higher 37% to 40%
US tax rate.
So, the Ireland domicile essentially arrives at our corporate rate to be at that lower rate. So
going forward, we can develop more products in Ireland. We can invest in the United States without
having to repatriate cash because well be an Irish Company, so investments in the United States
dont have to deal with a repatriation issue. And ultimately, we think its going to give us a lot
more flexibility as we grow to manage the tax rate more effectively for our shareholders.
And so, we havent given a lot of detail around that, but as we go thats something obviously were
going to be working on, something Elan has done very well over time. And I think one of the
(inaudible) in other companies that have tried to do it, I think the benefit that we have is were
actually merging with a bona fide Irish Company thats been in operation for 40 years and has 500
people working Ireland. In fact, Athlone will be our largest site. The next nearest is probably
Wilmington, with slightly about 290 people.
So, its going to give us a nice base to look at the world, and from a financial perspective should
be quite efficient.
Any other questions? Okay, I guess thats a wrap. Sorry I spoke for so long. Thank you very much
for your attention.
7
Final Transcript
May 24, 2011 / 10:00AM GMT, ALKS Alkermes Inc at UBS Global Specialty Pharmaceuticals Conference
DISCLAIMER
Thomson Reuters reserves the right to make changes to documents, content,
or other information on this web site without obligation to notify any person
of such changes.
In the conference calls upon which Event Transcripts are based, companies may
make projections or other forward-looking statements regarding a variety of
items. Such forward-looking statements are based upon current expectations and
involve risks and uncertainties. Actual results may differ materially from
those stated in any forward-looking statement based on a number of important
factors and risks, which are more specifically identified in the companies
most recent SEC filings. Although the companies mayindicate and believe that
the assumptions underlying the forward-looking statements are reasonable, any
of the assumptions could prove inaccurate or incorrect and, therefore, there
can be no assurance that the results contemplated in the forward-looking
statements will be realized.
THE INFORMATION CONTAINED IN EVENT TRANSCRIPTS IS A TEXTUAL REPRESENTATION OF
THE APPLICABLE COMPANYS CONFERENCE CALL AND WHILE EFFORTS ARE MADE TO PROVIDE
AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR
INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE CONFERENCE CALLS. IN NO
WAY DOES THOMSON REUTERS OR THE APPLICABLE COMPANY OR THE APPLICABLE COMPANY
ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON
THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY EVENT TRANSCRIPT. USERS
ARE ADVISED TO REVIEW THE APPLICABLE COMPANYS CONFERENCE CALL ITSELF AND THE
APPLICABLE COMPANYS SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER
DECISIONS.
© 2011 Thomson Reuters. All Rights Reserved.
8