Written Communication Relating to an Issuer or Third Party (sc To-c)
12 November 2013 - 10:31PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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SCHEDULE TO
TENDER OFFER STATEMENT UNDER SECTION 14(D)(1)
OR 13(E)(1) OF THE SECURITIES EXCHANGE ACT OF 1934
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VIROPHARMA INCORPORATED
(Name of Subject Company (Issuer))
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VENUS NEWCO, INC.
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SHIRE PHARMACEUTICAL HOLDINGS IRELAND LIMITED
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(Names of Filing Persons (Offeror))
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Common Stock, Par Value $0.002 Per Share
(Title of Class of Securities)
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928241108
(Cusip Number of Class of Securities)
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Michael Garry
Shire Pharmaceutical Holdings Ireland Limited
5 Riverwalk, Citywest Business Campus,
Dublin 24, Ireland
+353 1 4297700
(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)
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Copies to:
George R. Bason, Jr.
William J. Chudd
Davis Polk & Wardwell
450 Lexington Avenue
New York, New York 10017
Telephone: (212) 450-4000
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Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.
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Check the appropriate boxes below to designate any transactions to which the statement relates:
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x
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third-party tender offer subject to Rule 14d-1.
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issuer tender offer subject to Rule 13e-4.
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going-private transaction subject to Rule 13e-3.
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amendment to Schedule 13D under Rule 13d-2.
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Check the following box if the filing is a final amendment reporting the results of the tender offer.
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Draft 12
Shire acquisition of ViroPharma
- Strategic move to strengthen Shire's Rare Disease business - Augments already
strong growth prospects
Flemming Ornskov, MD
Chief Executive Officer
Graham Hetherington
Chief Financial Officer
Our purpose
We enable people with life-altering conditions to lead better lives.
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CAUTIONARY STATEMENT REGARDING FORWARD -LOOKING STATEMENTS
Statements included in this communication that are not historical facts are
forward -looking statements. Forward -looking statements involve a number of
risks and uncertainties and are subject to change at any time. In the event
such risks or uncertainties materialize, results could be materially adversely
affected. The risks and uncertainties include, but are not limited to, that:
[]Shire's proposed acquisition of ViroPharma may not be consummated due to the
occurrence of an event, change or other circumstances that gives rise to the
termination of the merger agreement;
[]a governmental or regulatory approval required for the proposed acquisition
of ViroPharma may not be obtained, or may be obtained subject to conditions
that are not anticipated, or another condition to the closing of the proposed
acquisition may not be satisfied;
[]ViroPharma may be unable to retain and hire key personnel and/or maintain its
relationships with customers, suppliers and other business partners pending the
consummation of the proposed acquisition by Shire, or ViroPharma's business may
be disrupted by the proposed acquisition, including increased costs and
diversion of management time and resources;
[]difficulties in integrating ViroPharma into Shire may lead to the combined
company not being able to realize the expected operating efficiencies, cost
savings, revenue enhancements, synergies or other benefits at the time
anticipated or at all;
and risks and uncertainties detailed from time to time in Shire's or
ViroPharma's filings with the U.S. Securities and Exchange Commission,
including their respective most recent Annual Reports on Form 10-K.
ADDITIONAL INFORMATION AND WHERE TO FIND IT
This communication is for informational purposes only and does not constitute
an offer to purchase or a solicitation of an offer to sell ViroPharma common
stock. The offer to buy ViroPharma common stock will only be made pursuant to a
tender offer statement (including the offer to purchase, letter of transmittal
and other related tender offer materials) . Investors and security holders are
urged to read both the tender offer statement (which will be filed by Shire
subsidiaries with the Securities and Exchange Commission (SEC) and the
solicitation/recommendation statement on Schedule 14d-9 with respect to the
tender offer (which will be filed by ViroPharma with the SEC) when they become
available because they will contain important information, including the terms
and conditions of the offer. Investors and security holders may obtain a free
copy of these materials (when available) and other documents filed by Shire and
ViroPharma with the SEC at the website maintained by the SEC at www.sec.gov.
The tender offer statement and related materials, and the
solicitation/recommendation statement, may also be obtained (when available)
for free by contacting Shire Investor Relations, at [+1 781 482 0999 or +44
1256 894157] .
Copies of these materials and any documentation relating to the tender offer
are not being, and must not be, directly or indirectly, mailed or otherwise
forwarded, distributed or sent in, into or from any jurisdiction where to do so
would be unlawful.
To be as brave as the people we help.
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Compelling strategic rationale
Flemming Ornskov, MD
Chief Executive Officer
Our purpose
We enable people with life-altering conditions to lead better lives.
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Compelling acquisition rationale
Excellent strategic fit with Shire's rare disease expertise
Augments Shire's already strong growth profile
Adds CINRYZE ([R]) (C1 esterase inhibitor [human]) -- a growing product which
is complementary to FIRAZYR ([R]) Shire expects annual cost synergies of
approximately $150 million by 2015 Immediately accretive to Non-GAAP EPS and
enhances earnings growth profile Shire expects transaction to deliver ROIC in
excess of weighted average cost of capital
To be as brave as the people we help.
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ViroPharma Incorporated background
[] Founded in 1994, with a commitment to the
development and commercialization of innovative products that address unmet
needs History [] The company has grown through a focus on Business Development,
most recently acquiring Lev Pharmaceuticals Inc. in 2008 and DuoCort Pharma AB
in 2011
[] Key product is CINRYZE indicated for routine
prophylaxis against angioedema attacks in adolescent and adult patients with
Hereditary Angioedema (HAE) Products [] Other marketed products include
BUCCOLAM ([R]) (midazolam oromucosal solution) and PLENADREN ([R])
(Hydrocortisone, Modified Release Tablet)
[] Additional pipeline assets
[] NASDAQ listing
[] 410 employees as at 31 December 2012
Facts [] Head office in Exton, PA with other locations in countries throughout
the EU
[] Manufacturing rights to CINRYZE held by Sanquin, based in the Netherlands
To be as brave as the people we help.
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Expected to create a growing ~$2 billion Rare Disease business
On closing, CINRYZE will make an immediate and significant contribution to
the Rare Disease business []
Sales estimates based on 2013 consensus sales forecasts (1)
[] supported by a track record of significant growth
Cinryze US sales since launch ($m)
*Viropharma has guided to North American sales of $395m - $405m for 2013
To be as brave as the people we help.
(1) Shire consensus sales forecasts: based on the most recent consensus sales
estimates compiled by Consensus Forecast Ltd, as of the date of this release
for the year ending December 31, 2013, available on Shire's website CINRYZE
sales forecasts: based on FactSet consensus for year ended December 31, 2013
(accessed 4 November 2013)
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ViroPharma strengthens our growing In-Line portfolio
Gastrointestinal Regenerative
Rare Diseases Neuroscience Internal Medicine
(GI) Medicine
To be as brave as the people we help.
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[R] (C1 esterase
CINRYZE inhibitor [human])
Our purpose
We enable people with life-altering conditions to lead better lives.
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Hereditary Angioedema (HAE)
Edema attack
[] HAE is a very rare but debilitating genetic disorder characterized by
unpredictable and recurring edema (swelling) attacks, of varying duration,
severity, and frequency (see below)
[] There are approximately 7,000 -- 8,000* US HAE sufferers, of which an
estimated 3,000 -- 4,000 are treated**
[] Many patients continue to be treated with androgens
Source: US HAEA website
HAE is a variable condition that can be life threatening Complementary
treatment options are necessary
Infrequent symptoms
Acute treatments -considered poor candidates for prophylaxis due to low disease
burden
Frequent/moderate symptoms
Prophylactic therapy may be added, depending on individual patient preferences/
characteristics. Patients still should have access to acute therapy
Frequent/severe symptoms
Severe patients have high need and generally receive prophylaxis and acute
treatment for breakthrough attacks
To be as brave as the people we help.
*Agostoni A, Aygoren -Pursun E, Binkley KE, et al. Hereditary and acquired
angioedema: problems and progress: proceedings of the third C1 esterase
inhibitor deficiency workshop and beyond. J Allergy Clin Immunol 2004;114(3
Suppl):S51 -131 **Internal market research
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FIRAZYR and CINRYZE are complementary therapies
Acute therapy
[] Acute attacks of HAE in adults of 18 years and older
[] 1,500 patients have tried Firazyr in the US, and 2,500 in Europe
[] Suitable for adult patients with acute episodes
[] On-demand, self-administered, portable, SQ
[] Monotherapy for patients with infrequent attacks
[] Adjunctive therapy to treat breakthrough attacks for patients using
prophylaxis
Prophylactic therapy
* Prophylaxis treatment of HAE in adolescents and adults
* ~ 1,000 patients on therapy in US and Europe
* Used in moderate to severe HAE patients
* 2 infusions per week, IV
* 75% of patients are treated through IV infusion at home
* Many patients still experience breakthrough attacks despite their
prophylactic treatment and thus require acute treatment options
CINRYZE and FIRAZYR occupy different market segments; where overlap in
patients exists, the products are complementary
To be as brave as the people we help.
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]
Delivering value from transaction
Driving future CINRYZE growth
1. Leverage of Shire's infrastructure:
- International commercial expertise and infrastructure
- RandD expertise
- Biologic manufacturing expertise
2. Expansion of patient outreach programs
Additional In-Line products
Synergies Pipeline optionality
To be as brave as the people we help.
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Transaction details
Graham Hetherington
Chief Financial Officer
Our purpose
We enable people with life-altering conditions to lead better lives
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Proposed transaction details
Offer price of $50 per share in cash
Total consideration of approximately $4.2 billion
Pending anti-trust authority clearances, it is anticipated that the transaction
will close in the last quarter of 2013, the first quarter of 2014 or as soon as
possible thereafter
The transaction is not subject to any financing contingency
To be as brave as the people we help.
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Financial benefits to Shire
Creates a Rare Disease business unit with a growing $2 billion revenue base(1)
Enhances Shire's short and long term revenue growth
Shire expects annual cost synergies of approximately $150 million by 2015
Immediately accretive to Non-GAAP EPS and augments earnings growth profile in
short and long term Shire expects transaction to deliver ROIC in excess of
weighted average cost of capital
To be as brave as the people we help.
(1) Shire consensus sales forecasts: based on the most recent consensus sales
estimates compiled by Consensus Forecast Ltd, as of the date of this release
for the year ending December 31, 2013, available on Shire's website CINRYZE
sales forecasts: based on FactSet consensus for year ended December 31, 2013
(accessed 4 November 2013)
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Financing
Funded using: [] cash on hand
[] existing $1.2bn committed bank facility [] newly arranged $2.6bn short term
bank facility
Financing arranged also provides Shire with sufficient capacity to repay
Shire's existing $1.1 billion convertible bond in May 2014 if required
To be as brave as the people we help.
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Summary
Excellent strategic fit
Increases rare disease portfolio which Shire is strategically committed to
strengthen
Attractive financial profile
To be as brave as the people we help.
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Questions and Answers
Our purpose
We enable people with life-altering conditions to lead better lives.
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Appendix
Our purpose
We enable people with life-altering conditions to lead better lives.
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Two further marketed products
PLENADREN ([R]) for adrenal insufficiency in adults
[] Modified release hydrocortisone for adrenal insufficiency in adults []
European approval received 2011, with launches underway [] Discussions with FDA
ongoing regarding US regulatory path
BUCCOLAM ([R]) for prolonged seizures in children and adolescents
[] Oromucosal midazolam provided in an individual dose formulation for buccal
delivery [] Portable, ready to use, pre-filled oral syringe containing an age-
specific dose [] Approved in the EU in 2011 [] Launched in seven EU countries
plus one in the Middle East
To be as brave as the people we help.
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ViroPharma development pipeline (ex CINRYZE additional indications)
Subcutaneous [] Phase 3 ready
CINRYZE [] An optimized, low volume version of CINRYZE for subcutaneous
administration (HAE) [] Discussions with FDA for pathway into Phase 3 planned
for 1H 2014
Maribavir [] Phase 2 studies in refractory and treatment na[]ve CMV patients
ongoing in US and EU respectively (CMV in [] Unique mechanism of action
transplant [] Encouraging Ph2 data reported June 2013 with viral clearance
observed patients) [] Top line data expected 2014
[] Phase 2 results reported April 2013
VP20621 [] A non-toxigenic spore based strain of C. difficile that helps
to prevent recolonization with toxic strains (c. difficile) [] Phase 2 studies
showed a favourable tolerability profile with 98% having no recurrence of
infection [] Further data evaluation underway to determine next steps
[] Phase 2 studies ongoing in eosinophilic
esophagitis (EoE), a chronic inflammatory disorder of Oral budesonide the
esophagus affecting an estimated 160,000 patients in the US alone (eosinophilic
[] Being developed by Meritage Pharma -- ViroPharma has an option to acquire
esophagitis) [] A proprietary formulation of budesonide that acts topically on
the esophagus [] Orphan Drug designation, no treatments currently available []
Phase 1 currently enrolling
VP20629
[] A small molecule for the treatment of Friedreich's Ataxia, a life
threatening, multi-system
(Friedreich's degenerative disorder
Ataxia)
[] Affects 1 in 50,000 people -- no therapies available currently
To be as brave as the people we help.
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ViroPharma development pipeline -- CINRYZE additional indications
Antibody mediated [] Phase 2a rejection in [] ~1,600 transplant patients
globally are positive cross match but therapy could expand number of renal
transplant potential transplant patients
[] Phase 1
Autoimmune
[] Target population of approximately 20,000 (the 10% of the 200,000 incident
US and EU population that
Hemolytic Anemia is not well managed by current therapies)
Neuromyelitis [] Phase 1
Optica [] Target population of approximately 20,000 in US and EU
(Devic's syndrome)
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Financial outline of ViroPharma (in $m)
2010A 2011A 2012A
Cinryze 177 251 327
Vancocin 260 289 91
Other 3 5 10
Total Revenues 439 544 428
YoY growth 24% -21%
Cost of Goods sold (61) (80) (109)
Gross Profit 378 464 319
Gross margin 86% 85% 75%
RandD (40) (66) (68)
SGandA (96) (128) (174)
Amortisation (29) (31) (35)
Other (1) (17) (9)
Operating income 212 222 33
Operating margin 48% 41% 8%
Outline prepared using historic company data under US GAAP
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About CINRYZE (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma -derived C1
esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for
routine prophylaxis against angioedema attacks in adolescent and adult patients
with HAE. In the E.U., the product is approved by the EMA for the treatment and
pre-procedure prevention of angioedema attacks in adults and adolescents with
HAE, and routine prevention of angioedema attacks in adults and adolescents
with severe and recurrent attacks of HAE, who are intolerant to or
insufficiently protected by oral prevention treatments or patients who are
inadequately managed with repeated acute treatment. Cinryze is for intravenous
use only.
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have
occurred in patients receiving Cinryze, and in patients receiving off-label
high dose C1 inhibitor therapy. Monitor patients with known risk factors for
thrombotic events. With any blood or plasma derived product, there may be a
risk of transmission of infectious agents, e.g. viruses and, theoretically, the
CJD agent. The risk has been reduced by screening donors for prior exposure to
certain virus infections and by manufacturing steps to reduce the risk of viral
transmission including pasteurization and nanofiltration.
The most common adverse reactions in clinical trials associated with Cinryze
were rash, headache, nausea, erythema, phlebitis and local reactions at the
injection site. Adverse events of sinusitis and upper respiratory infection
also were observed in clinical trials. No drug-related serious adverse events
were reported in clinical trials.
Please visit http://www. viropharma. com/products/cinryze. aspx for the full
U.S. Prescribing Information; the prescribing information for other countries
can be found at www.viropharma. com.
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About FIRAZYR
FIRAZYR is currently approved in 41 countries worldwide, including the
countries of the European Union and the United States for the treatment of
acute attacks of HAE in adults.
After injection training, patients may self-administer FIRAZYR. Most patients
respond to a single dose of FIRAZYR. If response is inadequate or if symptoms
recur, up to 2 additional doses may be administered within a 24 hour period at
intervals of at least 6 hours.
Important Safety Information
Because laryngeal attacks may be fatal, patients with laryngeal symptoms should
administer FIRAZYR and immediately seek medical attention. The most commonly
reported adverse reactions were injection site reactions, which occurred in
almost all patients (97%) in clinical trials. These most frequently included
redness and swelling. Other common adverse reactions reported in at least 1% of
patients included fever, transaminase increase, dizziness, and rash.
Full U.S. prescribing information for FIRAZYR is available at www.FIRAZYR. com.
For more information about HAE visit www.haea.org. Prescribing information may
differ between countries. Please consult your local prescribing information.
To be as brave as the people we help.
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