UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14D-9
SOLICITATION/RECOMMENDATION STATEMENT
UNDER
SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934
Sepracor Inc.
(Name of Subject Company)
Sepracor
Inc.
(Name of Person(s) Filing
Statement)
Common
Stock
(Title of Class of Securities)
817315104
(CUSIP Number of Class of Securities)
Andrew I.
Koven, Esq.
Executive Vice President, General Counsel and Corporate Secretary
Sepracor Inc.
84 Waterford Drive
Marlborough, Massachusetts
01752
(508) 481-6700
(Name, Address and Telephone Number of Person Authorized to Receive
Notices
and Communications on Behalf of the
Person(s) Filing Statement)
Copies to:
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William J. Grant, Jr.
Russell L. Leaf
Adam M. Turteltaub
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York, New York 10019
(212) 728-8000
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Hal J. Leibowitz
Susan W. Murley
Lia Der Marderosian
Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, MA 02109
(617) 526-6000
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x
Check the box if the filing relates solely to preliminary
communications made before the commencement of a tender offer.
The
following is a transcript of a conference call hosted by Dainippon Sumitomo
Pharma Co., Ltd. (DSP) on September 3, 2009 regarding the proposed
acquisition of Sepracor Inc. (Sepracor).
2
FINAL TRANSCRIPT
Thomson StreetEvents
SM
450600.T -
DAINIPPON SUMITOMO PHARMA CO LTD Merger & Acquisition Announcement to
Acquire Sepracor Conference Call
Event
Date/Time: Sep. 03. 2009 / 10:00AM GMT
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FINAL TRANSCRIPT
Sep. 03. 2009 / 10:00AM,
450600.T - DAINIPPON SUMITOMO PHARMA CO LTD Merger & Acquisition
Announcement to Acquire Sepracor Conference Call
CORPORATE
PARTICIPANTS
Masayo Tada
Dainippon
Sumitomo Pharma Co. Ltd. - President & CEO
Hiroshi
Nomura
Dainippon
Sumitomo Pharma Co. Ltd. - Executive Officer
Yutaka
Takeuchi
Dainippon
Sumitomo Pharma Co. Ltd. - Executive Officer, Chief Director of Business
Strategy
C O N F E R E N C E C A L L P A R T
I C I P A N T S
Hidemaru Yamaguchi
Citigroup - Analyst
Ryoichi Urushihara
Nomura
Securities - Analyst
Mr. Sawada
JP Morgan
Asset Management - Analyst
Fumiyoshi
Sakai
Credit
Suisse - Analyst
Hiroshi
Tanaka
Mizuho
Securities - Analyst
Shinichiro
Muraoka
Morgan
Stanley - Analyst
Yasuhiro
Nakazawa
Mitsubishi
UFJ - Analyst
Mr. Kaneko
- Analyst
Samuel Law
Deutsche
Asset Management - Analyst
PRESENTATION
Unidentified
Company Representative
(Interpreted) Thank you very
much for coming to the explanation meeting for the acquisition of Sepracor. I
would like to extend my heartfelt gratitude for coming despite very late in the
evening. We would like to introduce the members from our Company - Masayo Tada,
the Representative Director, President and Chief Executive Officer and also
Yutaka Takeuchi, the Executive Director of Strategic Planning and Business
Development, as well as Hiroshi Nomura, the Corporate Planning, Finance and
Accounting. And Tada is going to explain according to the materials at hand.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Thank you very
much, ladies and gentlemen. In spite of your busy schedule and in spite of the
busy of the short notice announcement late at night, still we have so many
people. We express our gratitude to all of you. Already Nikkei newspaper has
reported according to their speculation so you may be aware of the agreement.
But just our Company has agreed with Sepracor in US regarding the TOB and the
agreement on acquisition. And we reached agreement and we will explain the
background and also the contents of the agreement. We would like to explain so
that you will understand the situation.
4
I hurt my hip joint and it is
difficult for me to keep standing as I explain to you. So please allow me to
explain to you while I sit. Thank you very much for your understanding.
Let me start explanation.
First, objectives of acquisition. Please open page two. We have our
mid-term plan and in February 2007 we announced our mid-term management
plan for the next three years. In that we stated we want to strengthen our
business basis as a global company. And looking ahead in 10 years and 15 years,
we want to be a global company which is R&D based pharma. And also the
overseas sales and domestic sales should be also the two pillars to support
business.
And Lurasidone is going to be
our first global product and this is under development which will be explained
later. In US we have the Phase III study positive results and it would submission
to FDA I think we can do that ahead of the schedule. And we expect that we can
start launching 2011 and we are preparing sales and marketing network for that.
Regarding sales and marketing
platforms we had considered three options, in-house development or alliance or
acquisition. The three options have been considered and as we acquired
Sepracor, it is clear that we chose acquisition. By this decision we are sure
that we will have a stronger platform in US and also realization of mid-term
plan will be accelerated.
This slide two shows the
first three years and also the next three years for take-off and we were
showing here mid-term and long term plan. And this mid-term plan will be for
the next five years. So in this background we have decided on this acquisition.
Now let me explain the
purposes and significance of the acquisition. We had other options like
in-house development and alliance, but compared to those options, acquisition
will enable us to retain profit in-house and potential for Lurasidone can be
achieved in a maximum manner.
The second aspect is we want
to strengthen our overseas business basis and by the acquisition of Sepracor,
about 40% of our sales will be from overseas.
The third point is in the with
the expansion of our pharma business and Sepracors first half 2009 at non-GAAP
basis, excluding special one-time event, their operating margin is about 28%.
So you can see Sepracor is a very profitable company and this will also
contribute to the expansion of our ethical drugs business.
And also we can expand the
development pipeline. Well have a stronger pipeline in US. They have a very
strong pipeline which will be explained later. They have also in-house
development and also some license-in. They have a continuous pipeline being
established so far and that will contribute greatly to our future performance.
Next page, slide page five.
This is overview of Sepracor. Overview is already explained in the press
release. In the following slides, we originally thought we are going to invite
CEO of Sepracor. If he could explain directly to you, we thought that would be
a very meaningful to you. But of course at the same time, the CEO of Sepracor
is explaining at the same time on the US side. So he is quite busy
unfortunately. Therefore he could not be here in person. What I explain to you
now is prepared by Sepracor. So that English material was translated into
Japanese and on behalf of the CEO of Sepracor I am explaining to you.
Overview is explained here.
This has been already communicated to you but let me highlight some aspects. On
the third line it talks about development of isomers and metabolites and
Sepracor has been a pioneer in this field.
And then the fourth line
below that Allegra, Clarinex, and Xyzal those three products compounds are
out-licensed and they are all isomers. They develop in-house and they
out-license to major pharmas. Allegra is to Sanofi-Aventis, Clarinex to
Schering-Plough and Xyzal to UCB. So they are licensed out to major
pharmaceutical companies. And also cash and cash equivalents as of June 30
this year about $500m.
Next page, page six
explains the continuous growth through business development. Established in
1984, Sepracor has developed various aspects and especially in 90s they have
succeeded in developing isomers. And in the late latter part of the 90s and
5
also early part of 2000,
Lunesta and then Xopenex, they have succeeded in developing those products. And
they have succeeded in marketing.
On the right hand side you
see a graph, 05, 06 you can see a drastic growth. Especially the blue part,
Xopenex and light blue Lunesta, those are leading products supporting Sepracors
business.
The sales network [has]
strengthened and through launching of these products they have very strong
marketing and sales platform in US market. And up to now, they have various
business models. And they have licensed out some products and that has been
promoted. And also in purple, except Canada business, there are some compounds
and they are licensed-in. Stedesa in red is shown in the bottom. This is also
licensed-in. In the past few years, there are some promising compounds
licensed-in and that is the new business model now.
Next slide please. The Total
Functional Capacity is the title. This company Sepracor is different from
so-called bio-ventures. Some companies do not have a sales force or sometimes
some specialty pharma do not have R&D. But Sepracor has full functions.
Marketing, for example. They
cover primary physicians and also specialists. They have about 1,200 MRs in the
marketing force. And also in R&D they originally started with isomers then
they have other products. There are new compounds which will be explained in
the CNS field. Against depression they have good candidates and there are six
INDs after 2003.
And business development this
is a direct translation. So license-in products and that kind of business, they
have been aggressively licensing-in products Omnaris, Alvesco, Stedesa. Those
are licensed-in products. In CNS area or in respiratory area, they have focused
and they have a unique strategy and very strong sales force. Therefore, they
have been very successful in licensing-in products.
Regarding manufacturing, the
Canada business is basically manufacturing business. And regarding the
management I will explain later. They have promoted various innovations and
they have a strong leadership in management.
Major products and sales
force is slide eight. Total MR number 1,200. Lunesta and Omnaris covering
primary care and 755 MRs. Other than that new product Brovana 150 MRs. Xopenex
and Alvesco have MR number of 295. So by products they allocate MRs and they
have the coverage nationwide.
Next is major pipeline
products in slide nine. As I touched upon these points, on the right hand side,
you see under FDA review and Phase III, Phase II and Phase I. And when you
follow those bars, you see there is no disruption. You have continuous
compounds in the pipeline other than licensed-in products. SEP for example,
225289 in Phase II and other SEP compounds are self-developed. Depression or
insomnia, those are their focus areas. Neuropathic pain and those are very
strong therapeutic areas.
Next page is talking
about the experienced management. The CEO, Mr. Adrian Adams, he used to be
the CEO of Kos Pharmaceuticals. And he developed Kos into a very positive manner
and he could sell it very well. So he has very good experience and good track
record. I have seen him many times. He knows about discipline and passion and
of course he is knowledgeable. He has wide experiences and he is a very capable
and trustworthy person as management. And other people listed here are also
high quality people, with very good experience. So they have a great management
line up.
Let me talk about merits or
advantages of acquisition. I mentioned four points as the meaning of acquisition
and Expected Effects of Acquisition is the title of this slide. And I will
explain in more detail about the significance of this.
The first, the potential to
accelerate penetration and maximize sales of Lurasidone in the US and how we
achieve that is explained. Sepracor has a strong sales and marketing network
and synergies with existing products in the CNS area. And also if we have to
start up ourselves it will take time and effort. But we can minimize time and
cost required to build an extensive sales network in US.
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And also the second point is
establish international platform. As I said before overseas revenue
contribution will be expanded to 40%. And in US we have only development
capability. But this transaction will enable DSP to establish sales platform in
this critically important market. So the infrastructure will be much
strengthened and that also includes to a regulatory affairs, IT and patent
strategies. And they have a very strong legal team. So that kind of
infrastructure can be obtained by this acquisition.
And as I said for the
business development, license-in, thats also very advantageous. In Canada,
manufacturing and the sales network will be developed. We can expand our
opportunity in in-license products. And also the expansion of R&D, they
have the capability and we can take advantage of that.
Next page. Now expansion of
the pharmaceutical business. Well, I touched upon before that Sepracor has a
very strong cash generating capability. At the first half of 2009, 28% was the
operating profit. So for the first half, that was the level. So they do have
the cash generating power which is indicated by this operating profit margin of
28%. Now in 2010/2011, we are going to face a very severe situation. However we
are expecting that by having this Sepracor in our family we will be able to do
have a contribution to revenues and profits.
And then the R&D expenses
well, we are spending about JPY55b and then in a non-GAAP basis, Sepracors R&D
expenses is about JPY25b. So in total, that will total up to the R&D of
JPY80b as our Group. And that will be available to us. And because of the
financial constraints there are some things that we were not able to do so.
However, that will be changed. We think that we will be able to do more in the
development of the strategic products and compounds.
And as for the development
pipeline, as I mentioned that the Sepracor has the very various pipeline in
various stages, from the early to the late stages. And so we consider that we
will be able to have the synergistic effects in CNS and respiratory and the
allergy area.
Now about the synergy. Well,
the CNS franchise will be able to be capitalized and thus we will be able to
penetrate the market earlier. And then we will be able to push up our revenue.
700 plus people are in the business of the Lunesta, of the hypnotic. Of course
they sell Lunesta and to be our schizophrenic agent is different. However, we
think that we will be able to capitalize on their experiences by having some
training. And by doing so we think that we will be able to expand the number of
the MRs for in the CNS area.
Now in terms of the cost
synergy, of course comparing to do it on ourself on our own, we will be able
to minimize the cost for hiring new MRs. And also we think that we will be able
to avoid the new investment for the infrastructure building in the United
States for the sales.
Now the Lurasidone. Well, the
primary objective is to do the sales of the Lurasidone after the successful
development. And we consider that the acquisition will be very significant in
having that sales system. And as for this schizophrenia, the PEARL 1 and PEARL
2, the Phase III studies, the two studies were carried out successfully. In the
PEARL 1, 80 milligrams and then in the second PEARL 2, the 40 and 120
milligrams showed a very good result vis-a-vis the placebo.
And then from starting the
end of the next year, we would like to start the PEARL 3 vis-a-vis the placebo.
And as I said here, for the bipolar disorder Phase III study which we call
PREVAIL its it will be available in terms of the result at the end of next
year.
And this has been shown
before but I think it was in August 26, we announced the results of the
PEARL 2. And this shows the efficacy in terms of the PANSS score vis-a-vis the
placebo. For the 40 milligrams and 120 milligrams, it showed significant
differences from 15 milligrams of Olanzapine. Likewise from the different index
we compared, that is vis-a-vis the CGI-S which is the secondary endpoint, the
same result has been shown.
And now about the weight
change. This PEARL 2, the study duration was six weeks and there was a
continuous multiple dosing through six weeks. And our Lurasidone was not
different in terms of the weight gain vis-a-vis the placebo. However, with
regard to the Olanzapine, the average of three kilograms was the weight gain.
And as you know the Olanzapine has this problem.
7
And now for the TGD triglycerides
has been measured as well. Compared to the Olanzapine, like in the case of the
weight gain, there was differences from the Olanzapine.
Now next is the expansion of
the pipeline in the West. And with regards to the licensing-in product, that is
only limited to the US market. But the green ones shows the US market and
Lurasidone as well. And our compounds are shown in green and the Sepracors
compounds that are already in the market are in red. And the Lunesta and
Stedesa are the ones that are going to be growing. And Stedesa is an
anti-epilepsy compound which we expect highly.
And the last two pages show
the overview of the acquisition and the financial impact.
Now about the acquisition
price, $23 per share was the price that we agreed upon. And there was a premium
over the closing price as of September 1. It was 27.6% . And the TOB has
started from September 1 and if we will be able to see the smooth going we
think that we will be able to conclude that in the mid October.
And then in the VOD of the Sepracor,
it was yesterday, categorically the acquisition by our Company was agreed upon.
And then in the premium we took the price at September 1. But there was a
Nikkei newspaper article coming out and that was still when the market was not
before closing of the US market. So the stock price actually went up to the
[stopping] level. And so that is why we had taken the closing price as of September 1.
And I mentioned that the it was categorically agreed upon on the part of
Sepracor. That is because they have taken into the expectations of the changes
in the stock price.
And then the as far as the
acquisition finance, the cash on hand is JPY50b and then the bridge loan
JPY200b. However, as for the permanent finances, we havent decided what will
be the one.
Now as far as the in-process
R&D and the good the impact on the goodwill or intangible assets that has
not been finalized. So we would like to announce when it is finalized.
Now as for the impacts on
EPS, because of the acquisition in the at latest in the fiscal year ending March 2012
we will see some positive result. And as for the amortization of the goodwill,
we think that we will be able to see a positive impact in the fiscal year
ending March 2011. And there are very uncertainties so we will not be able
to make a very definitive comment.
Now as for the shareholder
returns and this is going to be a very big investment or a big borrowing to do
the investment. So maybe there might be some suspicion or questioning coming
out. However, we would like to take the policy to have the stable dividend
payment. And also through this acquisition we think that we will be able to see
the positive growth which we would like to return to the shareholders.
And now because I wanted to
have question and answer time in a sufficient manner, so I would like to close
my presentation. Thank you.
QUESTIONS AND
ANSWERS
Unidentified
Company Representative
(Interpreted) We have our
Q&A session now. Your question is translated into Japanese through an
interpreter, one by one. (Operator Instructions).
8
Hidemaru
Yamaguchi
- Citigroup - Analyst
(Interpreted) Its Yamaguchi
from Citigroup. I have some basic questions. Lunesta and Xopenex, those two are
the major products of Sepracor. When do the patents for them expire?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) I am sure you
know that we investigate that. But 2012 and 2014 Lunesta 2014.
Hidemaru
Yamaguchi
- Citigroup - Analyst
(Interpreted) So for the few
years, you can maintain the current performance. But after the patent expires,
this Companys profitability will be undermined. And that is counted in your
decision of acquisition I suppose. And how do you make up for the loss when the
patents expire? And Lurasidone needs to be selling very well in order to cover
for that part of decrease. And Lurasidones estimated sales target is how much?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) I am sure you
are very much interested in this but I cannot comment on that because we want
to avoid misleading information. And the data we have now is all available to
you and you can just estimate on your own.
As you mentioned marketed in
US, Lunesta and Xopenex, the sales of two products are about 80%. But we have
new products and Stedesa is going to grow big. So with their current products
and products to be marketed its going to be good sales and then Lurasidone. So
Lurasidone when it is selling at peak then the expiration of patents will be
coinciding. So that could be we think this is a smooth transition. And this is
good for us and this is great for Sepracor also. This deal works very well and
one of the reasons is that the timing match for us and for them. They have what
we want and we have what they wanted. So that answers to your first question.
Hidemaru
Yamaguchi
- Citigroup - Analyst
(Interpreted) Okay. And
Lunestas domestic sales and marketing right is Eisai right? But you are
acquiring Sepracor and the global marketing right is going to be regained?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) No, not at all.
Hidemaru
Yamaguchi
- Citigroup - Analyst
(Interpreted) So Eisai
maintains the marketing right?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, I havent
read the agreement in detail too much. But there is this agreement and there
are various options we can think. But we dont think we have the marketing
right in Japan.
9
Hidemaru
Yamaguchi
- Citigroup - Analyst
(Interpreted) Lastly, the
finance, the amount is rather big. [CB] or just normal borrowing or are you
going to have equity involved?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) As you said we
have broad-based options available. So we will be very cautious. Bridge loan
will last for some time. So we would be considering that in a cautious manner.
Hidemaru
Yamaguchi
- Citigroup - Analyst
(Interpreted) Thank you very
much.
Unidentified
Company Representative
(Interpreted) Any other
questions?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, about the
patent time of the Xopenex, it will be until March of 2013. I made a
mistake, sorry.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) Thank you. I am
Urushihara from the Nomura Securities. Thank you very much for your
presentation. There are some several questions that I would like to pose.
The first one is about the
ones that have got the license in the Nycomed. Is it going to be a change of
control and is that going to be any relation with Nycomed?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Which ones are
you talking about?
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) Omnaris and
Alvesco.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) No, there is
going to be none.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) So about the
patent of the Lunesta you mentioned that it is up to 2014. Is it not up to
2012?
10
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) The patent is
until 2012. However we are planning to have extensions and Sepracor as well. We
think that we will be able to cover until 2014.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) Thank you. And
next is about the Lurasidone. In the explanations in May you said that the
FDA stance is that it is okay for you to file earlier because it is of a high,
good safety profile. That position has not changed?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Yes, I think
actually the safety profile was reconfirmed by the results of the PEARL 2.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) The last
question is about the research capability. Through the acquisition you said
that you would like to create and develop your own compound. Could you please
elaborate further?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
Y(Interpreted) es, the
research that the Sepracor is doing, for example, the anti-depressant or the
amino acids inhibitors are the compounds which are very unique and which have
not been touched by us. So the basic research well, its going to be R&D.
However, the idea or innovativeness and the research idea by the persons, they
are going to be very important.
So I think the Sepracor will
be able to develop the compounds that are very unique. And I think that will
complement our compound. So through the exchanges of the researchers I believe
that we will be able to see the synergy effect bearing fruit.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) So are you
planning to also streamline the organization?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, at the
present moment with regard to the organization, whether what we should do
with our research organization and their organization are not decided. What is
clear is that the sales organization, as soon as possible, we would like to
strengthen the marketing organization. So to that effect, we would like to
consolidate our marketing team to that of Sepracor.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) May I ask
one other question, about the goodwill? What will be the total of the goodwill?
Well, more specifically, in-process R&D, in rough figures, what will be the
percentage or the level of goodwill in-process R&D?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, Nomura
will answer.
11
Hiroshi
Nomura
- Dainippon Sumitomo Pharma Co.
Ltd. - Executive Officer
(Interpreted) Well, of
course, you know that the net assets and acquisition price differences will be
calculated. But we dont know about the in-process R&D level. And as for
the accounting of the in-process R&D, well, of course, there is a one way
to try to convert it at the time of the acquisition. And also that there is
another way to actually put it into the asset. But we have to consult with the
accountant. And we would like to decide how we are going to do that at the
in-process R&D.
Ryoichi
Urushihara
- Nomura Securities - Analyst
(Interpreted) But is it okay
to consider that in the interim report, so interim, settlement of the
accounting well be able to know?
Hiroshi
Nomura
- Dainippon Sumitomo Pharma Co.
Ltd. - Executive Officer
(Interpreted) Well, maybe, I
think so.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Any other
questions from the floor?
Mr. Sawada
- JP Morgan Asset Management - Analyst
(Interpreted) From JP Morgan
Asset Management, my name is [Sawada]. First, about Lunesta. There is patent
litigation against Teva. Could you give us an update including the schedule?
And what do you think of the risk to lose in this litigation? Thats my first
question.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) I hope you
understand that we cannot answer to that question so discussion regarding that,
no comment.
Mr. Sawada
- JP Morgan Asset Management - Analyst
(Interpreted) My second
question, the Xopenex patent expires in 2013, but in 2012, patent litigation
settlement coming in that time. I understand one company has this agreement to
start introducing generics by August 2012. I suppose you receive royalty,
but from August 2012, there will be a generic in the market. That is my
understanding. Is this correct?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, we cant
really answer to that question. There are various risks associated with patents
and we all consider that, and we considered probability of those risks, and we
come up with the final judgment decision about this acquisition. The points you
mentioned are incorporated in our decision process.
Mr. Sawada
- JP Morgan Asset Management - Analyst
(Interpreted) This is
mentioned in 10-K. So its just a fact-finding question. You mentioned 2013, so
I want to clarify the fact. And I wanted you to explain that clearly.
12
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) So there is one
company, a generic company is going to be around in the market by August 2012.
Mr. Sawada
- JP Morgan Asset Management - Analyst
(Interpreted) I think this
was released already, you had this compound in Phase II, I think it was 289,
this compound. You did not have a significant difference. I think that was
mentioned in the release. Regarding that, things are going to be rather
difficult going ahead. That is also included in your outlook?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Yes, we have
the outcome that you mentioned, and we are analyzing the data. And including
that, regarding this deal, the discussion is going on, and we had that kind of
result. And we have considered that.
And regarding this compound
289, this is from [TRI] group. And there is a back-up compound from the similar
group. So the back-up compounds can catch up, we hope.
Mr. Sawada
- JP Morgan Asset Management - Analyst
(Interpreted) Thank you very
much.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Then another
question in front.
Fumiyoshi
Sakai
- Credit Suisse - Analyst
(Interpreted) Sakai from Credit
Suisse. I would like to ask two questions. One is the kind of confirmation of
what you said about the VOD, the VOD categorically agreed that upon, and
approved the acquisition. And then, about the soaring of the share price
yesterday, you mentioned that the VOD has already taken into consideration the
likely growth of the share price.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Yes. That is
why I mentioned about Nikkeis article because we were very much concerned.
However, they had decided assuming that the share price is likely to go up. And
then, however, I think that there are other IRs so that the share price is
nearing to the TOB price. Then I think it might be a possibility to increase
the level of the bidding.
Fumiyoshi
Sakai
- Credit Suisse - Analyst
(Interpreted) Are you
concerned about that?
13
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, I dont
think I will be able to answer to that question. But I think its kind of
planned in the share price, concerning or knowing beforehand that there might
be some possibility that its going to the bidding is going to go up.
However, I think it will be normalized as everything settles.
Fumiyoshi
Sakai
- Credit Suisse - Analyst
(Interpreted) So we take this
acquisition, Sumitomo (inaudible) Chemistry, but the parent company, what kind
of role did they play? They didnt they werent involved at all?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Yes, basically
they werent involved. If you suspect that Sumitomo Chemical was involved, then
I am sorry about to hear that. But, well, I think to have the autonomy, I think
DSP will be able to decide on its own hand. And as for the financials, so yes.
Fumiyoshi
Sakai
- Credit Suisse - Analyst
(Interpreted). And then Id
like to ask about the pipeline. You said that Stedesa that is for the epilepsy,
you said that it is possible to expand. However, unless you get the
monotherapy, I dont think that you will be able to expand in the market. And
then also that I think the in 2010 January will come. Is that the right
understanding?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Yes. As for
Stedesa for epilepsy, the treatment for the epilepsy, and, well, I think
therefore its nature it cannot grow as much as the schizophrenic agent. And
then also Lunesta or Xopenex, and also they will have the patent expiration. So
we think that we will be able to cover everything. However, we consider that
however we will be able to cover the market risk with Stedesa.
Well, when I said the large
scale, I think you have jumped on my expression. But the feeling is that its
not as big as Lunesta. Stedesa is likely to grow. So please dont misunderstand
that Stedesa is going to grow as Lunesta. So next year, January, for Stedesa,
yes.
Fumiyoshi
Sakai
- Credit Suisse - Analyst
(Interpreted) And then as for
the results of the PEARL 2, I think Id like to ask Mr. Takeuchi because
240 milligrams and 120 milligrams that the reverse efficacy was shown. I dont
know whether 80 milligrams will be most effective dose. But how are you going
to treat or handle the 120 milligram dose? How shall we interpret the results
of the PEARL 2? Could you please say that?
Yutaka
Takeuchi
- Dainippon Sumitomo Pharma Co.
Ltd. - Executive Officer, Chief Director of Business Strategy
(Interpreted) Well, I might
have a long answer, but basically speaking, well, this schizophrenia or this
class of agent, have to do the clinical study with a very wide, different
patient background. So it was very difficult to have those dependent results.
Rather the PEARL 1 and PEARL 2, based on the results, the 40 milligrams to 120
milligrams with a therapeutic dose. And I think in a certain level, I think the
more the certain dose level was most effective to the schizophrenic patient.
14
So, based on that, I think
you can imagine that each and every patient has a different symptom. So for
each physician or investigator is actually deciding what dose will be the best
fit for the patient and then they are going to either up-titrate or down-titrate.
That is how it is handled. So from 40 milligrams to 120 milligrams, they will
rate it on how its able to be utilized in a very safe manner. And so I think
that will be very good advantage in the sales of Lurasidone.
Then for the hypertensive, I think
it is possible to monitor the blood pressure, so it is possible to narrow down
the patients background. However, that is not the case in the schizophrenia
area.
In case of the hypertensive,
I think that it is possible to have a very good, clean cut dose-dependent
result, however, not with this class of compound. And I dont know whether it
is going to be giving you some reference, but in PEARL 3 the 80 milligrams and
160 milligrams will be the dose. So I think that results based on the results
of the 80 milligrams and 160 milligrams which will be available next year, then
I think we will have a better understanding of what will be the best optimum
dose.
Fumiyoshi
Sakai
- Credit Suisse - Analyst
(Interpreted) Thank you.
Hiroshi
Tanaka
- Mizuho Securities - Analyst
(Interpreted) My name is
Tanaka from Mizuho Securities. I have two questions. Lunesta, when it was
launched, it grew very well. And then the patent would expire. And when you
look at the number of prescriptions, its coming down. But on accounting its
not coming down. I wonder why. So Lunestas new formulation was mentioned. What
is that?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) I think there
was some statement about the new formulation. Maybe its not mentioned in the
slides that we distribute today. But Lunesta, well, we do not have too much
detailed information about sales. But of course potential formulation agent has
much impact on sales, and how to market is also another factor for the sales.
For Lunesta, for the past
years, advertisement and promotion, much money has been spent for promotion.
Money and people are spent to increase sales, as I understand it. But in the
beginning of this year, as you know, their sales approach was changed. And for
the time being we think, and also Sepracors management thinks that they can
maintain the sales. And also for the formulation, rather than additional
indications, we, as I understand, they are thinking of new formulations.
Hiroshi
Tanaka
- Mizuho Securities - Analyst
(Interpreted) And about
development of Lurasidone, you have MRs over 750 people. And those people will
be used for promotion of Lurasidone. But for Lurasidone, you have about 300 to
350 people per specialist as the number of MRs, and you have about 750 MRs that
includes dealing with specialist, and also you have bipolar and I wonder if the
sales force is enough to cover all that.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Of course, we
need to talk with Adrian and other people, the Vice President of the Sales, we
need to talk. But we are thinking of making a separate group for Lurasidone,
then 750 people are in Lunesta and some will go to Lurasidone and some will be
newly hired. So thats going to be the sales team for Lurasidone. But the
number, when we do on our own, then 300 to 300 people, MRs, to be supporting,
but we would have more bigger numbers for the Lurasidone team. We dont know
exactly how many MRs are going to be in the sales team.
15
At the beginning we, of
course, want to have a head start for Lurasidone. So for that, we would like to
have more number of MRs. And that includes bipolar. Now, in the beginning, it
would be just schizophrenia. And after that, with bipolar, primary care aspect
will be included. Therefore we would need to review our sales force. Maybe
additional people is an option. So we do have flexibility because we have more,
stronger sales people.
Hiroshi
Tanaka
- Mizuho Securities - Analyst
(Interpreted) And you want to
retain your profit so you are not going to team up with others?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, that is
what we are thinking. But there are various players approaching to us, even
after the announcement of this alliance. And, as I said before, our new team
for the commercial and marketing aspect is going to be an integrated team. And
with this new team, how to promote Lurasidone is not really well discussed in
detail, so this is limited what I can say at present.
Hiroshi
Tanaka
- Mizuho Securities - Analyst
(Interpreted) Thank you very
much.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Thank you.
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted) Muraoka from
Morgan Stanley. Well, about this sale. Whether there was a market for bidder or
what is the background situation if you can give us that information?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, actually,
I will not be able to give the detail. But we are going to give some
information to the SEC. And there might be some information coming out from
Sepracor. But I am not in a position to talk about that.
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted) This $2.6b is
the acquisition price. That is the valuation of the sales and marketing force
and then the new compounds. But how are you prioritized and how shall I
interpret the valuation of $2.6b?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, from the
necessity point of view, well that is sales forces or the sale platform. The
Lurasidone sales was the most important, whether we are going do it on our own
or whether we are going to team up or acquire other company. That was the cycle
of our thinking. And then we looked for the potential possible company. And
then we found a very unique research company. And also the Sepracor, as I
mentioned earlier, it has a very good management. And this business development
is the
16
phrase that it utilized. And
it seems that they are doing very well in business development. And I think
this is a capability that is not held by our Company. And this other the two
major ones are patent and life cycle management.
Well, I think we will not be
able to have a long-term valuation, but in five or in 10 years time, we can
see we are going to face a very similar situation, but we think that because of
the high revenue, I believe that they are going to make a big contribution. And
that is how we evaluate.
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted) And so the
intangible asset is not so big. And goodwill is the biggest. And the [R&D]
is also so. That is how I interpreted your response. Am I right?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, Im not
talking of a strict definition. Well, in acquiring Sepracor, what is the most
important thing or what has the most biggest worth was considered, not from the
accounting returns, but we considered from our thinking. So we cannot
prioritize that from the accounting context.
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted) Now, the equity
financing, it includes the CB or only the debenture?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, I think
there are various ways. But I think theres various options and how we are going
to do and how we are going to do in what way is what we are going to consider
from now on.
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted) Now the last
question from myself is that the MR, you have 1,200. So when launching the
Lurasidone you are going to add some MRs, I believe. So but then the two
other compounds are going to expire reach the expirations of the patents. So
maybe you might want to reduce the MRs or not?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted). No, I dont
think so. As Takeuchi mentioned, this year, in January, that we have a kind of
streamlined well, and they have streamlined. However, they were able to do it
very efficiently and then they were able to increase their revenue. So they had
a very high quality type of business.
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted) So I think you
think that you are going to maintain this size?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Yes. I think
so.
17
Shinichiro
Muraoka
- Morgan Stanley - Analyst
(Interpreted). Thank you very
much for the explanation.
Yasuhiro
Nakazawa
- Mitsubishi UFJ - Analyst
(Interpreted) Nakazawa from
Mitsubishi UFJ. About Lunestas patent 2014 expiration, in what month does it
expire?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) February 2014.
Xopenex, 2013 in March.
Yasuhiro
Nakazawa
- Mitsubishi UFJ - Analyst
(Interpreted) Youre not
including pediatrics, but the pure patent expiration itself, is that what youre
talking about?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) I dont know
whether this includes extension by pediatric. I dont know that.
Yasuhiro
Nakazawa
- Mitsubishi UFJ - Analyst
(Interpreted) Okay. And this
is related to a previous question. What is the outlook when you have the
bipolar indication, then in addition to your own MR, maybe you think of
co-promotion. That is an option that you can have. Is this correct?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted). Well, options
are options. So it may be there is a possibility. But as of now, as I have
repeated, the sales force and the sales structure of Lurasidone, we are going
to have one central team. And that is decided and we have decided Lurasidone
team is going to be established. But what kind of structure and what kind of
timing, what kind of increase or decrease, none of them are decided yet.
And if the other companies
say we are going to join with you and we can still maintain good profit, then
we may do that, but things are not that easy. In the past few months, of
course, we considered various options, three options that I mentioned. But
things are not that easy.
Yasuhiro
Nakazawa
- Mitsubishi UFJ - Analyst
(Interpreted). And my last
question, Lurasidone patent is until July 2018. Is that right?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted). Maybe thats
going to be extended. Well, we dont have a high expectation. Of course, if
there is a possibility, they would like to extend that. Depending on
formulation, maybe there can be some kind of extension, but we should depend on
that too much as we think of business strategy.
18
Yasuhiro
Nakazawa
- Mitsubishi UFJ - Analyst
(Interpreted) Thank you.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Please? And
then afterwards we would like to entertain some questions from the web.
Mr. Kaneko
- - Analyst
(Interpreted) My name is
[Kaneko] and I am the for the Sumitomo Company shares. Sepracor as far as I
look, I think that the goodwill is going to be very large. So what about the
potential of the asset? Well, I dont know how to interpret. And then listening
to the presentation and the discussion so far, I think that goodwill will have
a very large impact on the equity base. Is it okay to consider such way, or
rather in the book base?
Well, I havent felt that the
goodwill is going to have a very large impact. What youre saying is that hard
to evaluate the tangible assets, because of the market price it is going to
increase. And then I saw that under the accounting report, theres not going to
be a very large intangible asset. But you think that theres going to be the
level is going to be increased because of the large goodwill? Well, it seemed
that when you were converting it into the market price, so when the acquisition
price minus the net asset, plus the goodwill, will be the intangible asset.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, we have
carried out a due diligence. However, when it comes to the evaluation of the
assets, after the acquisition is concluded, were going to have appraiser to do
the evaluation. So we dont know for sure. However, when it comes to the
balance that is between the net assets and also the acquisition price, then in
terms of the goodwill or the other intangibles that come out in the accounting
report will have a certain level. That is the feeling that I have.
Mr. Kaneko
- - Analyst
(Interpreted) Okay. I
understand. And then the second point, that is about the bridge loan. Have you
announced and publicized the due date of the bridge loan?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, we havent
announced it. However, in a common sense, it is short term because it is a
bridge, so its kind of a bridging loan to the next step, so short term.
Mr. Kaneko
- - Analyst
(Interpreted) And the last
question, well, the permanent finance, when you decide upon the permanent
finance, well, in terms of the financing, you mentioned that you havent taken
into the thinking of the Sumitomo Chemical itself. But, well, at the present
moment youre not considering to have the [CMS] together with the parent
company? Its only one option.
19
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Well, about the
financing, as I mentioned earlier, well, we have the autonomy. Of course, we
are the consolidated subsidiary. So I think that that happens. However, when it
comes to the way to fund or financing, we have a free hand. That is what Id
like to answer to you.
Mr. Kaneko
- - Analyst
(Interpreted) Thank you.
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) So next a
question from the telephone connection. A question from English-speaking
analyst, please?
Operator
The next question is from Mr. [Samuel
Law] from Deutsche Asset Management.
Samuel Law
- Deutsche Asset Management - Analyst
Good evening. Its actually
Samuel Law from Deutsche Asset Management. Ive got a couple of questions.
First of all, well, we know that you said you dont know how much it was going
to be. But I just wonder how youre going to treat the goodwill in your
depreciation schedule.
And also, looking at
Sepracor, in terms of looking at their P&L, well, at the moment, they are
paying a very small amount of tax. How long will that situation continue and
when will they start paying tax?
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Okay. About the
first question of goodwill and amortization schedule, in US GAAP, amortization,
it is going to be on the impairment charges. And when they are included on our
consolidation, then goodwill be amortized according to GAAP accounting
regulation.
As for the duration and
schedule, we need to talk with accountants. But based on the general practice
of Japanese companies, about 20 years amortization period seems like the
standard. Of course, we have not finalized and of course we need to talk with
the accountants.
And the second question,
about tax, NOL, a large amount of NOL is posted on accounting, therefore very
small tax cash out. If this deal is going to be closed, then change of control,
and based on US tax law, there will be a limit to NOL application. But
regarding that, we will maybe past NOL, we are not thinking that the past NOL
will be invalid. So that means that NOL that they had can be consumed. That is
our assumption. Thank you.
Samuel Law
- Deutsche Asset Management - Analyst
Thank you very much.
20
Masayo Tada
- Dainippon Sumitomo Pharma Co. Ltd. - President & CEO
(Interpreted) Then we would
like to return the microphone to the [stage]. If you have any questions, please
raise your hand. No questions?
Then thank you very much for
attending this site. Its late in the evening. We would like to end the
meeting. Thank you.
Operator
Thank you for taking time.
And that concludes todays conference call. You may now disconnect your lines.
Editor
Portions of this transcript
that are noted interpreted were interpreted on the conference call by an
Interpreter present on the live call. The Interpreter was provided by the
Company sponsoring this Event.
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21
Forward-Looking Statements
This material contains forward-looking statements that
involve significant risks and uncertainties. All statements that are not
historical facts are forward-looking statements, including: statements that are
preceded by, followed by, or that include the words believes, anticipates, plans,
expects, could, should or similar expressions; statements regarding the
anticipated timing of filings and approvals relating to the transaction;
statements regarding the expected timing of the completion of the transaction;
statements regarding the ability to complete the transaction considering the
various closing conditions; and any statements of assumptions underlying any of
the foregoing. All estimated or anticipated future results, product performance
or other non-historical facts are forward-looking and reflect Sepracors or DSPs
(as applicable) current perspective on existing trends and information.
Investors and security holders are cautioned not to place undue reliance on these
forward-looking statements. Actual results could differ materially from those
currently anticipated due to a number of risks and uncertainties that are
subject to change based on factors that are, in many instances, beyond Sepracors
and DSPs control. Risks and uncertainties that could cause results to differ
from expectations include: uncertainties as to the timing of the tender offer
and merger; uncertainties as to how many Sepracor stockholders will tender
their shares in the offer; the risk that competing offers will be made; the
possibility that various closing conditions for the transaction may not be
satisfied or waived, including that a governmental entity may prohibit, delay
or refuse to grant approval for the consummation of the transaction; the
effects of disruption from the transaction making it more difficult to maintain
relationships with employees, licensees, other business partners or
governmental entities; other business effects, including the effects of
industry, economic or political conditions outside of Sepracors or DSPs
control; transaction costs; actual or contingent liabilities; or other risks
and uncertainties discussed in documents filed with the U.S. Securities and
Exchange Commission by Sepracor, as well as the tender offer documents to be
filed by Aptiom, Inc. (Aptiom; a wholly owned indirect subsidiary of
DSP) and the Solicitation/Recommendation Statement to be filed by Sepracor.
Accordingly, no assurances can be given that any of the events anticipated by
the forward-looking statements will occur or, if any of them do, what impact
they will have on either Sepracors or DSPs results of operations or financial
condition. Neither Sepracor nor DSP undertakes any obligation to update or
revise any forward-looking statements as a result of new information, future
developments or otherwise.
Additional Information
The tender offer for the outstanding common stock of
Sepracor referred to in this material has not yet commenced. This material is
neither an offer to purchase nor a solicitation of an offer to sell any
securities. The solicitation and the offer to buy shares of Sepracor common
stock will be made pursuant to an offer to purchase and related materials that
Aptiom, a wholly owned indirect subsidiary of DSP, intends to file with the
U.S. Securities and Exchange Commission. At the time the tender offer is
commenced, Aptiom is required to file a Tender Offer Statement on Schedule TO
with the U.S. Securities and Exchange Commission, and thereafter Sepracor is
required to file a Solicitation/Recommendation Statement on Schedule 14D-9 with
respect to the tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO
PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS), AND THE
SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT
SHOULD BE READ CAREFULLY AND CONSIDERED BEFORE ANY DECISION IS MADE WITH
RESPECT TO THE TENDER OFFER. These materials will be sent free of charge to all
stockholders of Sepracor. In addition, all of these materials (and other
materials filed by Sepracor with the U.S. Securities and Exchange Commission)
will be available at no charge from the U.S. Securities and Exchange Commission
through its web site at http://www.sec.gov. Investors and security holders may
also obtain free copies of these documents that are filed with the U.S.
Securities and Exchange Commission from Sepracor at http://www.sepracor.com.
22
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