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Exhibit 99.1
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 to Merge with Elan Drug Technologies (EDT) to Create
Alkermes plc Conference Call
Event Date/Time: May 09, 2011 / 12:30PM GMT
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Final Transcript
May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
CORPORATE PARTICIPANTS
Rebecca Peterson
Alkermes, Inc. VP Corporate Communications
Richard Pops
Alkermes, Inc. Chairman, President, CEO
Shane Cooke
Elan Corporation, plc EVP, CFO, Head of Elan Drug Technologies
Jim Frates
Alkermes, Inc. SVP, CFO, Treasurer
CONFERENCE CALL PARTICIPANTS
Cory Kasimov
JPMorgan Analyst
Terence Flynn
Goldman Sachs Analyst
Ami Fadia
UBS Analyst
Steve Yoo
Leerink Swann Analyst
Biren Amin
WJB Capital Group Analyst
Dave Windley
Jefferies & Co. Analyst
Bill Tanner
Lazard Capital Markets Analyst
Tom Russo
Robert W. Baird Analyst
PRESENTATION
Operator
Welcome to the Alkermes corporate conference call. My name is Matt and I will be your operator
for todays call. At this time all participants are in a listen-only mode. Later we will conduct a
question-and-answer session. Please note that this conference is being recorded.
I will now turn the call over to Ms. Rebecca Peterson. Ms. Peterson, you may begin.
Rebecca
Peterson Alkermes, Inc. VP Corporate Communications
Thanks, Matt. Welcome to the Alkermes conference call to discuss our definitive agreement with
Elan to merge with the Elan Drug Technologies business unit. With me today from Alkermes are
Richard Pops, our CEO; Jim Frates, our CFO; and from Elan Drug Technologies, Shane Cooke, Executive
Vice President and head of Elan Drug Technologies.
Before we begin let me remind you that during the call today we will make forward-looking
statements relating to, among other things, our expectations concerning the consummation of the
merger between Alkermes and EDT; potential shareholder benefits resulting from the merger;
commercialization of RISPERDAL CONSTA, VIVITROL, BYDUREON, and products in EDTs commercial
portfolio; the timing of additional development activities for BYDUREON; the approval and
commercialization of BYDUREON in the US and in the EU; our future financial expectations and
business performance; and our expectations concerning the therapeutic value and development of our
products and those of EDT.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Listeners are cautioned that these forward-looking statements are neither promises nor
guarantees and are subject to risk and uncertainty. Our press release issued today and our annual
report on Form 10-K for the fiscal year ended March 31, 2010, identify certain factors that could
cause our actual performance to differ from the results contemplated by these forward-looking
statements. We undertake no obligation to update or revise the information provided on this call as
a result of new information or future results or developments.
Our annual report on Form 10-K is available from us or online through the Company website or the
SEC website. Slides to accompany the call today can be found on the investor relations section of
our corporate website at www.Alkermes.com.
Today, Richard Pops, will provide an overview on the proposed transaction, and Shane Cooke will
provide some additional background information on EDT, followed by a discussion of the terms and
financial aspects of the transaction by Jim Frates. After our remarks we will open up the call for
Q&A. Now, I would like to turn over the call to Richard. Rich?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Great. Thank you, Rebecca, and hello, everybody. Greetings from Dublin. Actually we are not in
Dublin anymore; we are in Athlone, Ireland, which is about an hour and a half west of Dublin.
This morning, as you just heard, we announced a definitive agreement to merge with Elan Drug
Technologies, or EDT. The transaction is immediately accretive to our cash earnings, and it will
bring new revenue streams, business opportunities, and scale to Alkermes. Our top-line revenues
will jump to over $450 million annually, and we will become a profitable Company on a cash earnings
basis.
This starts a new phase of growth for us. We are incredibly enthusiastic about this transaction,
and we are quite happy to be able to announce it today, after several months of intense diligence
and structuring.
It is 1.30 in the afternoon here and we have already had a full day of meetings with the Irish and
European media and investors, so I can tell you already that this transaction is generating a lot
of interest and excitement.
So let me begin by just outlining the key features of the transaction and give you a sense of what
the new company, Alkermes plc, is going to look like. You can think of the formation of Alkermes
plc as being transformative in two different dimensions, financially and operationally.
So first from a financial standpoint, Alkermes plc will be immediately profitable on a cash
earnings basis, with strong and expanding adjusted EBITDA margins. Alkermes plc will have growing
revenues in excess of $450 million a year from over two dozen products, including revenues from
five major commercial products with long patent lives that we see driving future growth, all in
significant disease areas that affect millions of patients. And as an Irish company, we leverage
decades of operating history at Elan and add new financial, legal, and strategic features to
Alkermes.
Second, from an operational perspective, the deal is also transformational. We believe that
Alkermes plc will be one of the worlds most significant biopharmaceutical companies, with a track
record of successful drug development, and an exciting pipeline of high-potential drug candidates,
with particular focus in the CNS area.
The company is going to have global operational scale, headquartered in Dublin, Ireland, with
approximately 1,200 employees in the US and Ireland; established R&D expertise based on proprietary
technologies; world-class GMP manufacturing sites for complex drug formulations at Alkermes
facility in Wilmington, Ohio, and EDTs facilities in Gainesville, Georgia, and Athlone, Ireland.
We are going to have a powerful combination of expertise and financial resources to grow and
maximize the value of the product portfolio. So what we are building is a new, powerful engine for
near- and long-term growth.
The most immediate opportunity from the merged entity comes from the five major commercial products
I mentioned. These products are largely in the early stages of the product lifecycle and positioned
for strong growth trajectories in large markets.
So here is the list AMPYRA, VIVITROL, BYDUREON, RISPERDAL CONSTA, and INVEGA SUSTENNA. So lets
take them one at a time.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
AMPYRA is a potassium channel blocker, approved just last year in the US as a treatment to
improve walking in patients with multiple sclerosis. It has had a rapid launch and is continuing to
gain traction in the MS market. It has patent protection through 2026. Our manufacturing and
royalty rate will be 18% of net sales.
VIVITROL is the first and only once-monthly extended-release injectable treatment for alcohol
dependence and was recently launched in a promising new indication for the prevention of relapse to
opioid dependence following opioid detoxification. VIVITROL has patent protection through 2029.
This is our proprietary product; so we book all of the top-line sales.
BYDUREON is just coming out of the gate as the first once-weekly GLP-1 for type 2 diabetes with the
CHMPs recommendation for approval only a few weeks ago in Europe, and plans to refile in the US in
the second half of the year. BYDUREON has patent protection through 2025 and our worldwide royalty
there will be 8% of net sales globally.
Lastly, two of our most significant growth phase contributors will be the long-acting atypical
antipsychotics RISPERDAL CONSTA and INVEGA SUSTENNA. For those of you who have been following our
Company for a while, you will recognize the addition of INVEGA SUSTENNA to the portfolio as highly
complementary.
With this transaction, Alkermes will earn substantial revenues not only from CONSTA, as we have for
years, but we will also earn royalties on worldwide sales of INVEGA SUSTENNA. Thus Alkermes plc
will be completely aligned with J&Js ongoing strategy of growing the long-acting atypical class
overall. This positions us as the clear leader in the long-acting antipsychotic space and removes
any concerns about the competitive positioning of the two products.
The royalties that Alkermes plc will receive on SUSTENNA are on par with the net manufacturing and
royalty revenues we currently earn from CONSTA. So the merger with EDT results in a win-win with
respect to our position in the atypicals market.
In addition to providing significant near-term revenue growth opportunities, the combined
commercial portfolio also gives us the resources to invest smartly in the combined companys
pipeline, which will serve as a springboard for the long-term growth. Both Alkermes and EDT have
proven development capabilities and track records for creating innovative commercial products.
The pipeline of Alkermes plc will build upon the proprietary pipeline we have been building so
actively here for the past few years and will reinforce our position as one of the most exciting
companies in the CNS space. The combined pipeline will include promising candidates from both
Alkermes and EDTs proprietary pipelines and is focused on important disease areas where we have
established expertise, such as schizophrenia, treatment-resistant depression, reward and impulse
control disorders, and pain.
Late-stage candidates in this portfolio include ALKS 9070 for schizophrenia; ALKS 33 for multiple
indications across various reward disorders; ALKS 33 buprenorphine combination for
treatment-refractory depression and cocaine addiction; ALKS 37 for opioid-induced constipation;
ZX002, an EDT-partnered product for pain with potential safety advantages; and meloxicam IV, an EDT
nonsteroidal anti-inflammatory drug candidate for pain.
While this is a truly transformational transaction, some things will remain the same. The new
company will be listed on the NASDAQ Stock Exchange. I will remain CEO of the new company, and
senior leadership at both companies will remain intact.
Importantly, there will be continuity across the board, and we are happy to welcome the leadership
from EDT, including Shane Cooke as president of Alkermes plc, who has been in key positions in Elan
for the last 10 years, including serving as CFO of Elan and head of EDT. I have gotten to know
Shane well over the last several months, and I am really looking forward to working with him.
And with that I will close, and I will turn it over to Shane.
Shane Cooke Elan Corporation, plc EVP, CFO, Head of Elan Drug Technologies
Thanks, Rich, and good morning and good afternoon to everybody. I am delighted to be joining
the team and believe that the merger of Alkermes and EDT will create a lot of interest amongst the
investment community.
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Final Transcript
May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
The combination is an ideal fit at the right time, when both businesses are strong and
positioned for growth. EDT has many commercial products, two of which INVEGA SUSTENNA and AMPYRA
are at the beginning of their growth trajectories. More than a year after launches in the US, we
have a clear sense that the revenue streams provided by these products will be a major driver for
growth on top of EDTs foundation of diversified revenues.
Further, both companies have complementary and world-class drug formulation and manufacturing
capabilities and share a focus on developing medications for the treatment of CNS diseases in major
markets like schizophrenia and pain, which led us to the compelling strategic conclusion that
bringing these two companies together will create an organization poised to uncover innovative
ideas, develop market-leading products, make a positive impact for patients, and deliver value to
shareholders.
EDT is a cash generating, profitable business with a proven and successful business model. We have
been focused on applying our proprietary formulation technologies to create and commercialize
medicines that have a meaningful impact.
EDT has developed 35 products over its more than 40-year history, 22 of which are on the market
still today. Our two principle drug technology platforms are the oral controlled-release
technologies and the bioavailability enhancement platform, which includes NanoCrystal, the
technology behind INVEGA SUSTENNA. I would also like to underscore here that EDTs role as an
innovator approximately 40% of EDTs 2010 revenue was derived from EDT-originated product ideas,
including well-known brands like AMPYRA, AVINZA, NAPRELAN, and VERELAN.
EDT earns royalties on commercialized products, contract revenue from candidates that it is
developing in partnership with pharmaceutical companies, and manufacturing revenues from the
production of commercialized products that incorporate EDTs proven technology as well as contract
manufacturing revenues. We are confident that the combined company, Alkermes plc, will have the
development and manufacturing expertise as well as the financial resources to advance the promising
candidates in EDTs proprietary pipeline and ensure uninterrupted product supply to EDTs
commercial partners.
At Elan, we have long recognized that the EDT and bioneurology businesses are different. They have
different risk profiles, capital requirements, and investment time horizons.
Consequently, we explored how we might separate the businesses in a manner which would allow each
business to realize its full potential, while at the same time deleveraging Elans balance sheet.
This transaction fulfills these objectives; and importantly, the structure of the deal enables Elan
to participate in this new company with a very significant potential to create future value.
On a personal level, the EDT team and I have very much enjoyed working with the Alkermes team led
by Rich over the last several months, and we are very excited to be a part of the new Alkermes plc.
Rich has very eloquently laid out for you the strategic rationale and the growth opportunities that
lie ahead, and we share his optimism and enthusiasm for that future.
I am particularly pleased that Alkermes plc will be an Irish company headquartered in Dublin, which
is a location from which to build an international business. With that, I will hand the call over
to Jim. Jim?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Thanks, Shane; good day, everyone. As Rich noted earlier, in addition to all the strategic
advantages offered by the formation of Alkermes plc, this transaction will result in enhanced
financials and has been structured at favorable terms to Alkermes. The transaction is valued at
approximately $960 million, with Elan to receive $500 million in cash and 31.9 million shares of
the new Alkermes plc.
Elans appetite for this ownership in Alkermes plc underscores their belief that the companys
growth potential is clear and tangible. As part of its ownership, Elan has entered into a
shareholder agreement which will include a firm lock-up provision designed to manage the timing and
the manner in which its shares are sold, as well as an agreement to vote its shares in alignment
with Alkermes plc.
Let me describe the mechanics of the transaction. Alkermes and EDT will be combined under a new
holding company incorporated in Ireland, creating a financially efficient structure. Existing
shareholders of Alkermes, Inc., will receive 1 share of Alkermes plc in exchange for each share of
Alkermes they own at the time of the merger. This is expected to be a taxable event for our
shareholders.
This transaction is expected to close in the third quarter of this calendar year. We will use a
combination of our current cash and debt financing to fund the acquisition.
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Final Transcript
May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
We have committed financing in place from Morgan Stanley and HSBC for $450 million. We also
currently have over $290 million in cash as of March 31. So we have the flexibility in terms of how
much debt we will incur.
We believe that the operating cash flow provided by the combined business will allow us to access
the debt markets on favorable terms. For instance, even if we borrow all $450 million under our
committed financing, our pro forma total debt to adjusted EBITDA ratio based on the trailing 12
months would be only 4.6 times, and our net debt to adjusted EBITDA would be 2.5 times. We expect
these ratios to improve quickly as we grow EBITDA and pay down debt. Further, we expect cash flows
from the joint business will be sufficient to repay this debt in four to five years.
Let me give you a sense of the financial picture of the combined company now. While we will provide
additional results from our fiscal-year 2011 year on May 18, we can tell you that Alkermes
revenues for the year were approximately $185 million. So that on a trailing 12 month basis as of
March 31, 2011, the combined company would have had pro forma revenues of approximately $450
million and adjusted EBITDA of approximately $80 million.
Now looking forward on a pro forma basis, revenues for Alkermes plc are expected to grow from this
level in fiscal 2012 and to reach double-digit growth rates in fiscal-year 2013 and beyond. Pro
forma adjusted EBITDA margins for Alkermes plc are expected to be in the 15% to 20% range in
fiscal-year 2012, yielding pro forma adjusted EBITDA of between $70 million and $90 million. And we
expect EBITDA margins to expand to the 30% to 35% range in fiscal 2013 and beyond.
Operationally this combination is very complementary. Since EDT is a unit of Elan and does not have
significant corporate overhead, there isnt substantial overlap in our business operations. That
said, approximately $20 million of annual synergies in US operations have been identified and are
expected to be fully realized by fiscal 2013. We will provide further financial guidance for
Alkermes plc following the closing of the transaction.
This is an exciting and financially sound transaction for us on many levels. The expansion of
revenue sources significantly diversifies our existing portfolio in terms of both products and
geography. We will make the transition from deriving revenues from two products to having a
portfolio of 25 commercial products.
We will be immediately profitable on a cash earnings basis. We will have numerous new growth
drivers and the financial strength to grow earnings while investing prudently in an exciting
CNS-focused pipeline. With that, I would like to turn the call back to Rich for some closing
comments. Rich?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Thats great, Jim. Thank you; and thank you, Shane, as well. So there it is. The merger of
Alkermes with EDT makes tremendous financial and strategic sense on a number of levels.
By undertaking the transaction at this time we have positioned Alkermes for faster, more
diversified, and more amplified growth than would have been immediately achievable as a stand-alone
business. We think the transaction offers a long list of attractive features a stable base of
cash flows and earnings; near-term and sustainable growth through currently commercialized products
with no regulatory approval risk; additional business-enhancing new product candidates that
contribute to further growth in the out-years; global scale in capacity; and an exciting new
corporate structure, all in a package that pays for itself.
I couldnt be more excited and optimistic about the prospects for Alkermes plc. And with that, we
will open the call up for questions, and I will turn it back to Rebecca.
Rebecca Peterson Alkermes, Inc. VP Corporate Communications
Great. Operator, can you now queue up some questions?
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Final Transcript
May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
QUESTION AND ANSWER
Operator
(Operator Instructions) Cory Kasimov, JPMorgan.
Cory Kasimov JPMorgan Analyst
Hey, good morning, guys. Thanks for taking the question and congrats on the deal. More
importantly, Rich, I look forward to visiting you out in Dublin, hopefully sometime soon.
Richard Pops Alkermes, Inc. Chairman, President, CEO
You are welcome anytime, Cory.
Cory Kasimov JPMorgan Analyst
So first question. Can you comment at all I know you said you will have some more financial
guidance later; but can you talk a little bit about R&D spend going forward and whether or not now
youre going to have to embark on some sort of pipeline review?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Yes, I will answer that; and then I will ask Jim to make a comment on it as well. We will
provide guidance next week as we normally do in our May call on an Alkermes stand-alone basis, so
you can see what we are doing with the R&D line.
The R&D line is going to go up, but not in a dramatic way. But I think that the combined company
with the financial resources that it has and the portfolio that it has absolutely we are going
to have a jump ball between the top priority projects.
We will guide, I believe next week I am quite confident next week, and I believe even when we
guide for the combined company probably with the expectation of no partnering revenues in there,
simply to remove the uncertainty around that. But we are still, with such a rich portfolio and such
a large geographic opportunity and ownership to a lot of these products globally, we will still be
actively in the partnering, co-promoting, and strategic alliance business. But we probably wont
guide to that.
So the actual R&D spend will be the synthesis of what we spend ourselves and what comes in from the
partnering side as well. Jim, do you want to elaborate on that at all?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Yes, I will add a couple things, Rich. Thanks. The EDT business spent a little bit over $50
million in R&D in their last 12-month period. As you know, Cory, we are in the range of $90 million
to $100 million. So there will be a significant amount of R&D that these combined companies will
have to focus on a portfolio.
As Rich said, we are going to be combining that, focusing that. We will give you a little update on
where Alkermes plans are for fiscal-year 12 on a stand-alone basis.
But that is why I wanted to really stress the margins, though, and stress the fact that we think
EBITDA margins are going to be expanding. Because this is a story now focused on profitability and
growth, not just investing in a pipeline anymore.
Cory Kasimov JPMorgan Analyst
Okay, thats helpful. Then on the issue of SUSTENNA versus CONSTA, its kind of weird now that
they are both on the same team, from your standpoint. As you mentioned in your comments, we have
talked a lot in the past about how you believe CONSTA can defend its turf. But now that you do have
economics or you expect to have economics in both, can we turn around here and discuss what you
think the growth outlook is for the long-acting atypical market?
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Final Transcript
May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Richard Pops Alkermes, Inc. Chairman, President, CEO
Well, I think our view on the role of long-actings globally is a bullish one, because of
information that you are well aware of. That is the data showing superior outcomes for patients
even who are otherwise, quote unquote, stabilized on oral atypicals, particularly in the
schizophrenia indication.
Long-acting atypicals are really good medicine and I think they are also congruent with the
healthcare environment that we are in, where they save systems money over time. So J&J has always
argued to us that, as we have mentioned to you many times, that they see SUSTENNA and CONSTA
fulfilling slightly different needs in the marketplace and providing an opportunity to grow the
class overall.
We are extremely interested in that. As you know, we have 9070 in the pipeline ourselves, which is
another long-acting form of an important atypical antipsychotic; in this case aripiprazole. But,
generally I think that our view is bullish on the class.
Cory Kasimov JPMorgan Analyst
Okay. Then my last question for Jim. Can you just mention what the long-term tax implications
of this deal are, now that you are going to be headquartered in Ireland?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Sure, Cory. You know, Elan has been taxed at a roughly 12.5% rate over time, so the simplest
thing to do at this stage is to blend the two tax rates together. I think the overall corporate tax
rate will be in the range of 20% to 25%. But we will have more color on that as we develop our
projections over time.
Cory Kasimov JPMorgan Analyst
All right, great. Thats helpful. Thank you very much.
Operator
Terence Flynn, Goldman Sachs.
Terence Flynn Goldman Sachs Analyst
Hi, thanks for taking the questions this morning. Congrats as well. First, just wondering in
terms of your assumptions for double-digit growth in fiscal 2013; can you just comment on, I guess,
expectations for, number one, BYDUREON in the US; and then number two maybe AMPYRA in Europe; and
how they play into those assumptions on growth?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Jim, why dont you take that?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Sure, Terence; thanks. Good morning. You know, the benefit of this portfolio frankly is its
breadth. As I touched on we are going to have a number of products adding to that.
I would simply say that in the planning that we did for the purchase we did not assume a European
approval; so that would all be upside if things happen outside the United States in AMPYRA.
We do assume a US approval for BYDUREON along the lines of where the Street is essentially. I think
actually in the long-term modeling that we have done we used numbers for BYDUREON at or below
Street expectations.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Terence Flynn Goldman Sachs Analyst
Okay, great. Then in terms of are there any products currently in Phase 3 that EDT might be
eligible to receive royalty revenues on or manufacturing revenues on that we should be thinking
about?
Richard Pops Alkermes, Inc. Chairman, President, CEO
In our modeling, the core economic model is based on AMPYRA SUSTENNA, the portfolio of
approved products, and an analysis of meloxicam IV, which is in completed Phase 2 clinical
trials. But there is nothing and, Shane, you can correct me go ahead.
Shane Cooke Elan Corporation, plc EVP, CFO, Head of Elan Drug Technologies
There is a product which we have partnered with Zogenix, ZX002, which is a hydrocodone product
which we would expect to have Phase 2 or Phase 3 data sometime at the end of this year, early next
year. That is a product that if it gets approved we will get royalties on and we would also
manufacture.
Terence Flynn Goldman Sachs Analyst
Okay. Thanks a lot.
Operator
Ami Fadia, UBS.
Ami Fadia UBS Analyst
Hi, thanks for the question. Good morning. A couple of two quick questions actually. First
of all, if you could elaborate a little bit more on EDTs base business? I mean aside from the
newer, growing products, what are your assumptions around the trajectory of growth for the base
business?
Secondly, around the EBITDA margin expansion, what do you believe is going to really drive it? Is
it just top-line growth, or do you expect any improvements in the spending line?
And also if you could characterize where the synergies will come from.
Richard Pops Alkermes, Inc. Chairman, President, CEO
Thank you, Ami. Hi. Jim, why dont you go ahead with those?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Sure, thanks. Let me make sure I get them in order here. You know, the EDT base business as we
have talked about, Ami, is going to be really driven by growth in SUSTENNA and AMPYRA. We have
looked at the other breadth of the business royalties really staying steady over time, with a
slight amount of growth that has been really borne out in their historical financials.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
In terms of the margin expansion it is really the growth coming from the products I mentioned
on the EDT side, AMPYRA and SUSTENNA as well as BYDUREON and VIVITROL and RISPERDAL CONSTA,
frankly, continuing to remain a major product on the Alkermes side.
You know, the key thing for us is that RISPERDAL CONSTA was 85% of our revenues last year. In the
combined companies on a pro forma basis for fiscal-year 2011 it will be approximately 35%. So this
transaction massively diversifies our business.
Then on the cost side so we think the EBITDA margin expansion is going to come from growth in
those key products as well as improving margins over time as we pull the synergies out of the
operations in the United States. And again that is going to be generally some overlap in some
small overlap in manufacturing but mainly in our R&D spend, as we focus in on the products that we
are developing together.
Then finally, I will remind you as these products grow, SUSTENNA and BYDUREON are both pure
royalties for the business. So as they grow they really improve our margin in an outsized way
because they are going to drop straight to the bottom line. So hopefully that gives you some color.
Ami Fadia UBS Analyst
Yes, thank you so much.
Operator
Steve Yoo, Leerink Swann.
Steve Yoo Leerink Swann Analyst
Thanks for taking my question and congratulations on the deal. So I was wondering; of the
pipeline compounds in EDT, which is the one that is most exciting to you?
And now that you have the EDT business, do you have a change in R&D priorities going forward?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Hi, Steve. I am actually when I look at the EDT business, I am excited by two major
domains. Number one is the fact that they have got products that have been through the regulatory
hurdles and are beginning to grow. So essentially when we were modeling the business, putting aside
our respect for the technology, the oral controlled-release stuff, the nano-particulate systems, we
said can we justify this transaction and get excited about it simply based on the financial
aspects of it and the quality of the products that are already through regulatory approval? And our
answer to that was yes.
To answer your question, we think that the Zogenix product that Shane just mentioned as well as the
meloxicam IV, which has shown some very interesting data in its Phase 2 program in pain, are
interesting to us.
But when you take the basic capabilities within EDT and the track record and the experience in
formulation of complex drug molecules, and you marry that with ours on the R&D side, we actually
think there are going to be some new product candidates that emerge fairly quickly that neither of
us would have had the capability to do independently. We like the types of development programs, as
you know, in our Company that arent really based on brand-new biology and unproven pathways but
where we can address specific medical needs that we have identified in the context of patients
taking medicines every day for their diseases. And we are quite excited about what is going to come
from the combination in that regard.
Steve Yoo Leerink Swann Analyst
Okay. Lets see. As far as the VIVITROL patent, I believe you said 2029 on this call;
whereas previously, if I remember correctly it was 2017. Was there a new patent issued, or am I missing something?
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Richard Pops Alkermes, Inc. Chairman, President, CEO
That was a test and you passed it. So yes, we just had a patent issue last week, a new patent
on VIVITROL that takes that to that end.
Steve Yoo Leerink Swann Analyst
Okay. Also on the AMPYRA patent situation, I believe in US they just had a patent issued. But
how about in Europe? Do they have a method of use patent out there also?
Richard Pops Alkermes, Inc. Chairman, President, CEO
In Europe, we are modeling really based on the data exclusivity term which is about seven
years from approval.
Steve Yoo Leerink Swann Analyst
Okay. Thank you very much.
Operator
Biren Amin, WJB Capital.
Biren Amin WJB Capital Group Analyst
Hi, guys. Thanks for taking my question. I noticed on slide 16 of your deck you have included
TRICOR. I just wanted to get your thoughts on that product going forward, considering it is going
generic. What are your assumptions for that in 2012 and 2013?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Jim, why dont you answer how we model the financials; then I will ask Shane to comment on the
view forward.
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Yes. Thank you, Biren. We do have it actually beginning to trail off, as you might expect; and
it is not a major piece of our valuation going forward. Because after two years it is actually very
quite small numbers that dont play into that dont come into play.
Also I should note too theres also some guaranteed minimums, which is actually how we modeled it.
So those arent disclosed, but we are well in hand and TRICOR is not a risk for us.
Biren Amin WJB Capital Group Analyst
Great. Thanks.
Operator
Dave Windley, Jefferies & Company.
Dave Windley Jefferies & Co. Analyst
Hi, thanks for taking the questions. Rich, how does this affect your thoughts about developing
products for Alkermes own commercialization?
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Richard Pops Alkermes, Inc. Chairman, President, CEO
Well, I think that the premise of the whole transaction is that we are setting up stepping up
now to another level of play. Where our base assumption for many years was use partners resources
and diversification of the portfolio to assure that we would be able to build the Company stepwise;
and we have done that through a series of cash flows coming in from partnered products.
VIVITROL was our first foray into the proprietary product domain. But with the financial resources
here and with this nascent commercial enterprise that we are building, we have absolutely the scale
and the capability to bring products to market.
Now that said, there is such a tremendous demand, as you have heard me say many times, from large
pharma for innovative products with long patent life; and given the fact that so much of revenue in
the pharmaceutical industry comes from markets O-US now, we see ourselves continuing to partner and
collaborate while at the same time preserving commercial rights for many of these products.
So take them in turn. 9070 for example, long-acting injectable antipsychotic, we know how to sell
that product in the US. In Europe, we derive so much revenue O-US from RISPERDAL CONSTA, we know
that O-US markets are very, very important.
Alkermes plc has the beginning of a footprint where we could begin to build O-US. But that said, it
would also be a superb product to collaborate around, which to help us build that kind of
infrastructure.
So none of these thoughts are completely fully formed now, as we get together and start to map out
the business going forward. But our instinct is to capture more and more of the top line.
Dave Windley Jefferies & Co. Analyst
Okay, great. Jim, I wondered if the combination creates any opportunity to use more quickly or
more aggressively any NOLs? Any other (multiple speakers)?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Yes, Dave, that is a great question on the NOL front. So obviously we wont have to use the
NOLs in the United States in the United States; and then Elan has some NOLs in Ireland that we will
be able to use. So as we begin to do our tax planning, kind of post-deal, it is one of the definite
opportunities for us.
But I would say that the strategic rationale of the deal has really been combining the companies,
getting to immediate profitability, and making sure that we are not dependent on any one or two
products as we go forward. So there will be an opportunity for that, and I would say more on that
guidance later as we get closer to close.
Dave Windley Jefferies & Co. Analyst
Okay. So perhaps a slightly different way to ask the earlier question about tax rate. I think
you said that you expect the combined tax rate to be somewhere in the 20% to 25% range. Is that
what you expect early on with the benefit of perhaps some of these shields? Or is that more the
longer-term steady-state tax rate?
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Yes, David, I think it is a basic modeling of the Irish rates that Elan income is driven off
of, EDT income is driven off of. So they the basic tax rate, corporate tax rate in Ireland is
12.5%.
As we look at the US and we will do modeling here, because the plan is to borrow in the United
States; and so wed have those interest costs borne by the US business, not by the Irish business.
So overall I think as you plan out to do your DCF that is why I gave that 20% to 25% number, so
people could do long-term rates.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Dave Windley Jefferies & Co. Analyst
Got you. Okay.
Jim Frates Alkermes, Inc. SVP, CFO, Treasurer
Which would be an adjustment from if you were just looking at Alkermes, and a significantly
positive one.
Dave Windley Jefferies & Co. Analyst
Right, okay. Last question for you. Is Elan I understand the rationale here that they are
taking stock to continue to participate in the ups of the combined company. What are perhaps the
lock-up stipulations around that nearly 32 million shares?
Richard Pops Alkermes, Inc. Chairman, President, CEO
This is Rich. What we will do is we will when we file the 8-K and file the registration
statement, there will be exhaustive description of the shareholders agreement. In summary, as we
said in the press release, there is a fairly well-engineered shareholder agreement that provides
for a lock-up deal for a standstill and for orderly disposition of Elans stake over time, should
they choose to do that. Because one of the key features of this deal is, as you mentioned and I
am glad you brought it up this idea that Elan can participate in the value that we think is
going to be created through the combination over time.
Dave Windley Jefferies & Co. Analyst
Okay, great. Thank you.
Operator
Bill Tanner, Lazard Capital.
Bill Tanner Lazard Capital Markets Analyst
Thanks for taking the question. For Rich, maybe for you or Shane, just want to drill down a
little bit more on the EDT, just the pipeline. If anybody could speak qualitatively as to perhaps
maybe the number of products that are currently in develop or the addressable markets. And then
somebody could remind us on the underlying technology, what is the durability I guess of it from an
IP perspective.
And then I have one more.
Richard Pops Alkermes, Inc. Chairman, President, CEO
Yes, I will start, Bill; hi. I think that it is important for us to say for the purposes of
modeling and for the disclosure that we are making today we really just decided to pick on the
products that we think are the ones that are driving value. Theres a whole host of product
candidates and opportunities within EDT.
So we wont take you through the whole litany of it today. We are going to go through a very
extensive winnowing process on both sides of our R&D to make sure that we come up with the best
candidates to share with you. But what that as a preamble, I will ask Shane to comment on that.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Shane Cooke Elan Corporation, plc EVP, CFO, Head of Elan Drug Technologies
Yes, Bill. I think if you look at the core technologies are, the ones that we refer to, are
the oral controlled-release technologies and also the NanoCrystal technology, which has a whole
host of patents covering it and its application to various compounds and various methodologies out
for many years to come.
Then if you look at the pipeline, we have highlighted I suppose the later-stage ones, being
meloxicam and the hydrocodone product that we have partnered with Zogenix. There is probably a
dozen more compounds that we have that are in the clinic with partners of ours which we would
expect to be coming through to the market over the next several years.
Bill Tanner Lazard Capital Markets Analyst
Okay. Then maybe, Rich, just one last one for you. Do you anticipate that the activity just in
terms of trying to leverage the technology with partners, is that something that is going to
increase or decrease under Alkermes, I guess, as it was previously under Elan or stay the same?
Richard Pops Alkermes, Inc. Chairman, President, CEO
I think that we have so much opportunity on the proprietary pipeline and when you run the
numbers, the value of these pipeline projects, even if we were to move them forward into human
proof-of-concept and then partner them, is so much higher than just the incremental lower-royalty
drug delivery deal that I think that will probably be done by exception.
Now, on the manufacturing side EDT has a very, very strong record of manufacturing complex
pharmaceutical products for pharma. I think that there is actually an opportunity and a growing
opportunity to do more manufacturing of certain dosage forms for big pharma. So we will continue to
be a very actively partnering kind of company.
Bill Tanner Lazard Capital Markets Analyst
Okay, great.
Shane Cooke Elan Corporation, plc EVP, CFO, Head of Elan Drug Technologies
Maybe I would just like to endorse that, because it is something that we in EDT find so
attractive in this merger as well, is that we have been moving more towards creating our own
proprietary pipeline and having less of an emphasis on partnered projects, although its still a
very important part of the business.
I think part of the rationale from an EDT perspective is that this accelerates that very, very
rapidly for us as a business construct.
Bill Tanner Lazard Capital Markets Analyst
Okay, thanks very much.
Rebecca Peterson Alkermes, Inc. VP Corporate Communications
Operator, I think we have time for one more question, please.
Operator
Tom Russo, Baird.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
Tom Russo Robert W. Baird Analyst
Good morning and thanks for sneaking me in. Just to I guess go a little further on that last
point, I think we have seen Alkermes anyway in the last couple of years move away from drug
delivery and in the direction of earlier stage discovery. Is that should we expect I wanted
to distinguish between proprietary projects that could be also in drug delivery and just get a
sense of what your preference is for the combined company going forward, for earlier stage
discovery versus drug delivery projects?
Richard Pops Alkermes, Inc. Chairman, President, CEO
Thanks, Tom. I will take that one. I just went to be clear on the semantics. I dont think we
do very much early-stage discovery period at Alkermes in the classic definition in pharma of
Capital D Discovery, where were looking at new biology, new pathways.
Early-stage for us are things that are in the early stages of formulation, conception, and human
clinical trials. But what we like to do is put things into the clinic where we can get to human
proof-of-concept quite quickly, and with the achievement of human proof-of-concept move with a high
degree or a higher degree of confidence into the pivotal, more expensive phases of their
development.
I think take 9070 as an example of that, where it is well known that aripiprazole is an effective
antipsychotic drug. The study we are running right now is an early-stage study, right? It is a
Phase 1/2 type study. But when that study is complete this year and we have data on the
pharmacokinetic profile of 9070, we will know with a high degree of certainty whether it makes
sense to proceed into pivotal studies with that drug.
Likewise with ALKS 37 and opiate-induced constipation where the mechanism of action, a new receptor
blockade in the gut, makes sense. We know pharmacologically it makes sense.
So in the combined company, if you cruise around the laboratories youre not going to find people
in labs working on new biology. Youre going to find people applying these technologies and insight
into disease areas that we think we have an upper hand or with formulation insights that we think
give us an upper hand.
Tom Russo Robert W. Baird Analyst
Okay, thanks.
Richard Pops Alkermes, Inc. Chairman, President, CEO
Youre very welcome.
Rebecca Peterson Alkermes, Inc. VP Corporate Communications
Everyone, thank you very much for dialing in today. If you have any additional questions,
please dont hesitate to call investor relations at Alkermes. Thanks; have a good day.
Operator
Thank you, ladies and gentlemen. This concludes todays conference. Thank you for
participating. You may now disconnect.
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May 09, 2011 / 12:30PM GMT, ALKS Alkermes to Merge with Elan Drug
Technologies (EDT) to Create Alkermes plc Conference Call
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