DUBLIN and EXTON, Pennsylvania, November 11, 2013 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG) and ViroPharma Incorporated (NASDAQ: VPHM) today
announce that their Boards of Directors have unanimously approved, and the companies have
entered into, a merger agreement pursuant to which Shire will acquire all the outstanding
shares of the rare disease company ViroPharma for $50 per share in cash, for a total
consideration of approximately $4.2 billion. The $50 per share price in the transaction
represents a 27% premium to ViroPharma's closing share price on Friday, November 8, 2013,
the last trading day prior to announcement, and a 64% premium to ViroPharma's unaffected
share price of $30.47 on September 12, 2013.
ViroPharma is a high growth, rare disease biopharmaceutical company, whose commercial
product CINRYZE(R) (C1 esterase inhibitor [human]), is a leading brand for the
prophylactic treatment of Hereditary Angioedema (HAE).
Shire transaction highlights
- Excellent strategic fit
- Expands rare disease portfolio which Shire is strategically committed to
- Adds CINRYZE, with growing sales in the prophylactic treatment of HAE, which
complements Shire's FIRAZYR(R) (icatibant injection)
- Enhances Shire's short and long term revenue growth profile
- Expected annual cost synergies of approximately $150 million by 2015, over and
above the improved operating leverage already being driven by the ongoing One Shire
- Immediately accretive to Shire's Non GAAP EPS following completion and
enhances earnings growth profile
- Shire expects transaction to deliver ROIC in excess of its weighted average
cost of capital
- Acquisition to be effected by a tender offer and funded from Shire's cash
resources and existing and new bank facilities
- Conference call for investors today (details below)
Shire Chief Executive Officer, Flemming Ornskov MD, comments:
"The acquisition of ViroPharma will immediately benefit Shire and is entirely
consistent with our clear strategic objective of strengthening our rare disease portfolio.
It brings us a new growth driving product which augments our already strong growth
"Shire is uniquely positioned to drive the continued success of CINRYZE for the
benefit of patients through our knowledge of the rare disease space, our international
infrastructure and our biologics manufacturing expertise.
"Shire is also excited by the prospect of being able to offer two complementary
treatments, FIRAZYR for the treatment of acute HAE attacks and CINRYZE for prophylactic
treatment of patients suffering from HAE. Shire's priority will be to ensure CINRYZE
patients continue to enjoy high standards of service.
"Shire has conducted a thorough and collaborative due diligence process over the last
few months and, following completion of the transaction, the integration process will be
focused on delivering value to all stakeholders. This acquisition is expected to create a
$2 billion rare disease revenue base and delivers further strong growth prospects."
Vincent J. Milano, ViroPharma's Chief Executive Officer, stated:
"We are pleased to announce our merger with Shire, which like ViroPharma, is focused
on developing products for patients suffering from rare diseases.
"After thoroughly evaluating our strategic options we determined that this transaction
is in the best interests of ViroPharma, our shareholders and our patients.
"By joining with Shire, ViroPharma will become part of a larger, more diverse
biopharmaceutical company and will benefit from Shire's innovation, scale and global
reach. We will have access to resources to expand product distribution, giving us a
platform to provide our crucial therapies, such as CINRYZE, to more patients than ever
before. We look forward to working with Shire's team and to being part of an even
stronger, more geographically diverse organization."
Further information on ViroPharma
ViroPharma is a leading rare disease company with CINRYZE, a high growth product for
prophylactic treatment of HAE, as well as a number of other marketed products and a
pipeline of product candidates in the rare disease space. ViroPharma generated total
worldwide net revenues of $428 million in 2012. Total worldwide net revenues are forecast
by ViroPharma to be in the range of $445 million to $465 million in 2013.
Further information on CINRYZE
In the United States, CINRYZE is indicated for routine prophylaxis against HAE attacks
in adolescent and adult patients.
HAE is a rare genetic disease characterized by recurrent sudden attacks of swelling of
the skin or the mucous membranes which can be disfiguring, painful and potentially
life-threatening in the case of laryngeal attacks. Shire believes that of the
approximately 8,000 patients in the U.S. with HAE, the disease is only actively managed in
about 3,500 patients.
CINRYZE was approved with orphan drug designation in October 2008 and has grown
rapidly since launch in 2009 to generate revenues of $321 million in the U.S. in 2012. On
October 31, 2013, ViroPharma forecasted CINRYZE net revenues in North America in 2013 to
be between $395 million and $405 million.
Shire believes there is a significant opportunity for future revenue growth, in both
the U.S. and ex-U.S. markets, as new HAE patients are identified and treated and
additional physicians gain experience with this important therapy. Current consensus
estimates for global CINRYZE sales forecast strong revenue growth in the coming years.
CINRYZE has US orphan drug exclusivity which expires in 2015 and US biologics data
exclusivity until 2020.
With CINRYZE in its portfolio, Shire will be able to offer broader outreach to HAE
patients and a continuum of care alongside FIRAZYR.
Additional value from ViroPharma's other marketed products and pipeline
ViroPharma's portfolio of marketed products also includes PLENADREN(R) (hydrocortisone
modified release) and BUCCOLAM(R) (midazolam oromucosal solution), both recently launched
in major European countries. PLENADREN is a product for adrenal insufficiency in adults.
BUCCOLAM treats prolonged seizures in infants, children and adolescents.
The acquisition also brings ViroPharma's pipeline products to Shire, including two
phase 2 products being investigated for infectious diseases: Maribavir (for the treatment
of cytomegalovirus infection in transplant patients) and VP20621 (for the prevention of
recurrent Clostridium difficile infection). Also in the ViroPharma pipeline are VP-20629
for Friedreich's Ataxia, currently in phase 1, and an option to acquire Meritage Pharma,
which is conducting phase 2 trials with oral budesonide for the treatment of eosinophilic
esophagitis. ViroPharma has also sponsored or supported programs to examine potential new
indications for CINRYZE in Autoimmune Hemolytic Anemia, Antibody-Mediated Rejection post
renal transplantation and Neuromyelitis Optica.
Shire will review these programs as part of its regular pipeline review process to
ensure that Shire's R&D resources are appropriately deployed to those projects that are
both strategically relevant to Shire's commercial focus and have the greatest potential
Financial benefit to Shire
Shire expects the addition of CINRYZE to its Rare Disease Business Unit to create a
growing $2 billion revenue business in 2014 which will represent approximately 40% of
Shire's total product sales on a pro forma basis. The acquisition of ViroPharma is
expected to enhance Shire's revenue growth profile in both the short and long term.
Related to the acquisition, Shire estimates that it will realize approximately $150
million of annual cost synergies across the business by 2015, over and above the improved
operating leverage already being driven by the ongoing One Shire reorganization.
Following completion, Shire expects that the acquisition of ViroPharma will be
accretive to Shire's Non GAAP EPS immediately and in the longer term. Shire also expects
that the transaction will deliver ROIC in excess of its weighted average cost of capital.
Shire has secured a $2.6 billion fully underwritten short term bank facility, which,
in addition to Shire's cash and cash equivalents and its existing $1.2 billion revolving
credit facility, is available to finance the transaction, pay fees and expenses related to
the transaction and repay Shire's existing $1.1 billion convertible bond at its maturity
in May 2014 if required. Shire plans to refinance a portion of the short term bank
facility through new debt issuances and the use of ViroPharma's cash and short term
Share Buy-back program
Following the announcement of this transaction, Shire intends to terminate its share
buyback program. Shire's Board of Directors will continue to review Shire's capital
structure on an ongoing basis.
The acquisition is structured as an all cash tender offer for all the outstanding
shares of ViroPharma common stock at a price of $50 per share followed by a merger in
which each remaining untendered share of ViroPharma common stock would be converted into
the same $50 cash per share consideration as in the tender offer.
Closing of the transaction is subject to customary conditions, including the tender of
a majority of the outstanding ViroPharma shares and the receipt of regulatory clearances.
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 tender offer is not subject to a financing contingency.
Lazard and Morgan Stanley are acting as joint financial advisors to Shire.
Goldman, Sachs & Co. is acting as financial advisor to ViroPharma. Davis Polk & Wardwell
LLP is acting as legal advisor to Shire and Skadden, Arps, Slate, Meagher & Flom LLP is
acting as legal advisor to ViroPharma.
Conference Call with Shire CEO and CFO
Live conference call for investors:
Flemming Ornskov, MD, Chief Executive Officer and Graham Hetherington, Chief Financial
Officer will host the investor and analyst conference call today (Monday 11 November 2013)
at 08:30am GMT/03:30am EST.
The details of the conference call are as follows:
UK dial in: 08082370030 or 02031394830
US dial in: 1 866 928 7517 or 1 718 873 9077
International Access Numbers: Click here
Password/Conf ID: 30849732#
Live Webcast: Register here for the live webcast
A replay of the presentation will be available for two weeks by phone and by webcast
for three months. The details of the replay are below:
Playback number: +44 (0)20 3426 2807
Playback UK toll free number: 0808 237 0026
Password/Conf ID: 643242#
Webcast replay Click here
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Shire's strategy is to focus on developing and marketing innovative specialty
medicines to meet significant unmet patient needs.
Shire provides treatments in Neuroscience, Rare Diseases, Gastrointestinal, Internal
Medicine and Regenerative Medicine and we are developing treatments for symptomatic
conditions treated by specialist physicians in other targeted therapeutic areas.
About Hereditary Angioedema
HAE is a rare genetic disease caused by low levels or a dysfunction of C1 esterase
inhibitor (C1-INH). Reduced C1-INH activity can lead to elevated plasma levels of
bradykinin, which is thought to be responsible for HAE symptoms.
HAE is characterized by recurrent sudden attacks of edema (swelling) of the skin
(hands, arms, feet, legs, thighs, face, genitals) or the mucous membranes (
gastrointestinal tract, larynx or voicebox). The swelling can be disfiguring and painful,
especially in case of abdominal attacks. Laryngeal attacks are potentially
life-threatening due to the risk of suffocation. Unlike angioedema caused by allergic
reactions, signs and symptoms such as hives and itching do not occur in HAE. Signs and
symptoms of HAE do not respond to standard treatments for allergic angioedema such as
epinephrine, corticosteroids, and antihistamines.
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
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
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
http://www.FIRAZYR.com. For more information about HAE visit http://www.haea.org.
Prescribing information may differ between countries. Please consult your local
ViroPharma Incorporated is an international biopharmaceutical company committed to
developing and commercializing novel solutions for physician specialists to address unmet
medical needs of patients living with diseases that have few if any clinical therapeutic
ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases
including C1 esterase inhibitor deficiency, cytomegalovirus (CMV), Friedreich's Ataxia,
eosinophilic esophagitis (EoE) and adrenal insufficiency. ViroPharma's goal is to provide
rewarding careers to employees, to create new standards of care in the way serious
diseases are treated, and to build international partnerships with the patients,
advocates, and health care professionals it serves. ViroPharma's commercial products
address diseases including hereditary angioedema (HAE), seizures in children and
adolescents, adrenal insufficiency and C. difficile-associated diarrhea (CDAD). For full
U.S. prescribing information on ViroPharma's products, please download the package inserts
at http://www.viropharma.com/Products.aspx; the prescribing information for other
countries can be found at http://www.viropharma.com.
ViroPharma routinely posts information, including press releases, which may be
important to investors in the investor relations and media sections of ViroPharma's web
site, http://www.viropharma.com. ViroPharma encourages investors to consult these
sections for more information on ViroPharma and its business.
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
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
ADDITIONAL INFORMATION AND WHERE TO FIND IT
This announcement 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 Pharmaceutical Holdings Ireland Limited (SPHIL)
and a subsidiary of SPHIL with the U.S. 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 SPHIL and ViroPharma with the SEC at the website maintained
by the SEC at http://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 the contact information listed below.
ViroPharma also will provide a copy of these materials without charge on its website at
http://www.viropharma.com under the "Investors" section.
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.
1) Based on the most recent consensus estimates compiled by Consensus
Forecast Ltd, as of the date of this release, of combined net revenues for Elaprase,
Firazyr, Replagal and VPRIV for the year ending December 31, 2013, available on
Shire's website (http://www.shire.com/shireplc/en/investors/forecasts) and FactSet
consensus forecasts (downloaded November 4, 2013) for ViroPharma and for the year
ending December 31, 2014 for Shire.
SHIRE FORWARD - LOOKING STATEMENTS
Statements included in this announcement 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, Shire's results could be materially adversely affected. The
risks and uncertainties include, but are not limited to, that:
- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion;
- the failure to obtain and maintain reimbursement, or an adequate level of
reimbursement, by third-party payors in a timely manner for Shire's products may
impact future revenues and earnings;
- Shire relies on a single source for manufacture of certain of its products and
a disruption to the supply chain for those products may result in Shire being unable
to continue marketing or developing a product or may result in Shire being unable to
do so on a commercially viable basis;
- Shire uses third party manufacturers to manufacture many of its products and
is reliant upon third party contractors for certain goods and services, and any
inability of these third party manufacturers to manufacture products, or any failure
of these third party contractors to provide these goods and services, in each case in
accordance with its respective contractual obligations, could adversely affect Shire's
ability to manage its manufacturing processes or to operate its business;
- the development, approval and manufacturing of Shire's products is subject to
extensive oversight by various regulatory agencies and regulatory approvals or
interventions associated with changes to manufacturing sites, ingredients or
manufacturing processes could lead to significant delays, increase in operating costs,
lost product sales, an interruption of research activities or the delay of new product
- the actions of certain customers could affect Shire 's ability to sell or
market products profitably and fluctuations in buying or distribution patterns by such
customers could adversely impact Shire's revenues, financial conditions or results of
- investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated markets in
which it operates may result in the distraction of senior management, significant
legal costs and the payment of substantial compensation or fines;
- 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 obtained, or may be obtained subject to conditions that are not
anticipated, or another condition to the closing of the proposed acquisition may not
- 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 other 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.
VIROPHARMA FORWARD - LOOKING STATEMENTS
Statements contained or incorporated by reference in this document contain information
that includes or is based on "forward-looking statements". These statements include
statements regarding planned completion of the offer and the merger. We have tried,
whenever possible, to identify such statements by words such as "believes," "expects,"
"anticipates," "intends," "estimates," "plan," "projected," "forecast," "will," "may" or
similar expressions. Because these statements reflect our current views concerning future
events and are based on a number of assumptions that could ultimately prove inaccurate,
these forward-looking statements are subject to risks and uncertainties including, but not
limited to: all elements of our financial guidance for 2013, our ability to continue to
successfully commercialize our products in the United States and Europe, the timing and
results of anticipated events in our clinical development programs, and our ability to
identify and execute upon business development opportunities.
Our actual results may vary depending on a variety of factors, including:
- our ability to continue to identify and retain prophylaxis Cinryze
patients in the United States and Europe at the rate we anticipate, the total number
of potential prophylaxis Cinryze patients in the United States and Europe and our
market share of HAE patients in the United States and Europe;
- the size of the market, future growth potential and market share for Buccolam
and Plenadren in Europe;
- the availability of sufficient third party payer reimbursement for each of our
products in the United States and Europe;
- fluctuations in wholesaler and SP order patterns and inventory levels;
- competition from the approval of products which are currently marketed for
other indications by other companies or new pharmaceuticals and technological advances
to treat the conditions addressed by Cinryze, Buccolam and Plenadren;
- changes in prescribing or procedural practices of physicians, including
off-label prescribing of products competitive with Cinryze, Buccolam and Plenadren;
- manufacturing, supply or distribution interruptions, including but not limited
to our ability to acquire adequate supplies of Cinryze and our other products in order
to meet demand for each product;
- our ability to receive regulatory approval for the use of Cinryze for
additional indications and routes of administration and in additional territories in
the timeframes we anticipate or at all;
- the impact of healthcare reform legislation in the United States;
- actions by the FDA and EMA or other government regulatory agencies;
- the timing and results of anticipated events in our clinical development
programs including studies with Cinryze subcutaneous formulations, Cinryze for
antibody mediated rejection, and maribavir for treatment of CMV infections in
transplant recipients; and
- whether we pursue regulatory approval of Plenadren in the United States.
Biologics such as Cinryze require processing steps that are more difficult than those
required for most chemical pharmaceuticals, and as a result, Sanquin, our manufacturer of
Cinryze has received observations on Form 483 and a warning letter which require us to
continue to meet commitments made to the FDA related to various manufacturing issues. In
the event Sanquin fails to meet these commitments, the FDA may take actions that limit our
ability to manufacture Cinryze. In the event Sanquin is not able to manufacture the
anticipated volume of product at the industrial scale as a result of either FDA
requirements, batch failures, variability in batch yields, required maintenance or other
causes, we may not be able to satisfy patient demand or build safety stock. Our inability
to obtain adequate product supplies to satisfy our patient demand may create opportunities
for our competitors and we will suffer a loss of potential future revenues.
Forward looking statements related to the transaction include: the timing of the
filings and approvals relating to the transaction and the expected timing of the
completion of the transaction; uncertainties as to the percentage of the ViroPharma's
stockholders tendering their shares in the offer; the possibility 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 or may approve the transaction
with certain burdensome conditions that may result in a termination of the Merger
Agreement; the effects of disruption caused by the transaction making it more difficult to
maintain relationships with employees, collaborators, vendors and other business partners;
the risk that stockholder litigation in connection with the transaction may result in
significant costs of defense, indemnification and liability; and other risks and
uncertainties discussed in the ViroPharma's filings with the SEC, including the "Risk
Factors" sections of the ViroPharma's most recent annual report on Form 10-K and
subsequent quarterly reports on Form 10-Q, as well as the tender offer documents to be
filed by SPHIL and a subsidiary of SPHIL, and the Solicitation/Recommendation Statement to
be filed by ViroPharma. These risks, uncertainties and other factors, individually or in
the aggregate, could cause actual results and events to differ materially from those
referred to in the forward-looking statements. All forward-looking statements are based on
information currently available to ViroPharma, and ViroPharma assumes no obligation to
update any such forward-looking statements.
For further information please contact:
Eric Rojas, [email protected], +1-781-482-0999
Sarah Elton-Farr, [email protected], +44(0)1256-894157
Robert A. Doody, [email protected], +1-610-321-6290
Jessica Mann, [email protected], +44(0)1256-894-280
Gwen Fisher, [email protected], +1-484-595-9836
Paul Caminiti, [email protected], +1-212-687-8080
Robin Weinberg, [email protected], +1-212-687-8080
Michael Henson, [email protected], +44(0)20-3178-8914
SOURCE Shire plc & ViroPharma Incorporated