SUMMIT, N.J. Buy Glucophage Xr (Metformin) & SAN DIEGO--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) and Receptos, Inc. About Patanol (Olopatadine Hcl) with free prescription (NASDAQ:
RCPT) today announced the signing of a definitive agreement in which
Celgene has agreed to acquire Receptos. Buy Kamagra (Sildenafil Citrate) with no Rx Under the terms of the merger
agreement, Celgene will pay $232.00 per share in cash, or a total of
approximately $7.2 billion, net of cash acquired.
The acquisition of Receptos significantly enhances Celgene’s
Inflammation & Immunology (I&I) portfolio, further diversifies the
Company’s revenue beginning in 2019 and beyond, and builds upon
Celgene’s growing expertise in inflammatory bowel disease (IBD). About Depreks with free Rx The
transaction adds Ozanimod, a novel, potential best-in-class, oral,
once-daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator
(S1P) to Celgene’s deep and diverse pipeline of potential
disease-altering medicines and investigational compounds.
Based on clinical studies, Ozanimod demonstrated several areas of
potential advantage over existing oral therapies for the treatment of
ulcerative colitis (UC) and relapsing multiple sclerosis (RMS),
including its cardiac, hepatotoxicity and lymphocyte recovery profile. Xeloda (Capecitabine) without Rx
The phase III TRUE NORTH trial in UC is currently underway with data
expected in 2018. Buy Skin Care - Face online The phase III RADIANCE and SUNBEAM RMS trials are
ongoing and data are expected in the first half of 2017 to support a RMS
approval in 2018. http://medical-questions-answers.blogspot.com Additionally, Ozanimod is positioned to potentially
become the first S1P receptor modulator to be approved for IBD.
"The Receptos acquisition provides a transformational opportunity for
Celgene to impact multiple therapeutic areas,” said Bob Hugin, Chairman
and Chief Executive Officer of Celgene. “This acquisition enhances our
I&I portfolio and allows us to leverage the investments made in our
global organization to accelerate our growth in the medium and
long-term.”
Celgene has a strong scientific foundation in inflammation and
immunology that covers a broad spectrum of diseases. Anchored by the
successful global launch of OTEZLA® (apremilast) in psoriasis
and psoriatic arthritis, and new opportunities for expansion as a result
of the addition of the Receptos programs, Celgene’s I&I pipeline will,
upon completion of the transaction, consist of three high-potential
commercialized or late-stage assets; OTEZLA, GED-0301 and Ozanimod. All
three candidates are in phase III development and encompass four
indications: Behcet’s disease, Crohn’s disease (CD), UC and RMS. The
pipeline also includes seven molecules in phase II development in a
variety of indications, including RPC4046 for eosinophilic esophagitis
(EoE), and a growing number of phase I and preclinical assets. Learn
more about Celgene’s I&I pipeline here.
“In Celgene, we have found the ideal partner to maximize the potential
of Ozanimod and our promising pipeline in order to improve the lives of
patients worldwide,” said Faheem Hasnain, President and Chief Executive
Officer of Receptos.
“Ozanimod is a potentially transformational oral therapy that has
demonstrated robust clinical activity with impressive
immune-inflammatory modulating properties in phase II trials,” said
Scott Smith, President, I&I for Celgene. “Ozanimod is a highly
differentiated next-generation S1P receptor modulator with important
efficacy and safety features that create the opportunity for development
across a spectrum of immune-inflammatory diseases.”
Recent Receptos Clinical Data: Ulcerative Colitis
Ozanimod phase II data were presented by Receptos at the
Gastroenterology Conference Digestive Disease Week (DDW)
in May 2015 in Washington, D.C. The TOUCHSTONE phase II study,
evaluating Ozanimod in UC, met key clinical and endoscopic endpoints for
both induction and maintenance with statistical significance in patients
on the 1.0 mg dose of Ozanimod in the 8-week induction and 32-week
maintenance periods. The overall safety and tolerability profile of
Ozanimod was consistent with the results of the phase II trial in RMS. A
phase III program, TRUE NORTH, in UC has initiated enrollment and a
phase II program in CD is expected to initiate by year-end.
Recent Receptos Clinical Data: Relapsing Multiple Sclerosis
At the 2015 Annual Meeting of the American Academy of Neurology (AAN) in
Washington, D.C., Receptos presented results of an Ozanimod phase II
study in RMS. The study demonstrated that Ozanimod achieved the primary
endpoint of reduction in MRI brain lesion activity as well as secondary
endpoints measuring effects on other MRI parameters. The overall safety
profile of Ozanimod was consistent with the results of prior trials and
continues to demonstrate differentiation against other oral agents for
the treatment of RMS. Two phase III clinical trials are underway:
RADIANCE and SUNBEAM, both of which are randomized, controlled,
double-blind studies designed to compare 0.5 mg and 1.0 mg of Ozanimod
against interferon beta-1a (Avonex®) in patients with RMS.
Terms of the Agreement
Celgene will acquire all of the outstanding shares of common stock of
Receptos through a tender offer, followed by a second-step merger. In
the tender offer, Celgene, through a wholly-owned subsidiary, will offer
to purchase all of the outstanding shares of common stock of Receptos
for $232.00 per share in cash, or an aggregate of approximately $7.2
billion, net of cash acquired. The transaction has been approved by the
boards of directors of both companies and is subject to customary
closing conditions, including the tender of at least a majority of
outstanding shares of Receptos common stock and expiration of the
applicable waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976. The transaction is anticipated to close in
2015.
Celgene will acquire all remaining shares of Receptos common stock that
are not tendered in the tender offer through a second-step merger, which
will be completed shortly following the tender offer. Celgene expects to
fund the transaction through a combination of existing cash and new
debt. The resulting capital structure is consistent with Celgene’s
financial strategy and investment grade profile. This acquisition
maintains flexibility for additional value creating transactions and
share buyback.
J.P. Morgan and Citi are acting as financial advisors to Celgene on the
transaction. Centerview Partners LLC is acting as financial advisor to
Receptos. Legal counsel for Celgene is Proskauer Rose LLP, and Receptos’
legal counsel is Latham & Watkins LLP.
Preliminary Second Quarter 2015 Financial Highlights for Celgene
Preliminary net product sales of $2,254 million for the second quarter
of 2015 compared to $1,845 million in the second quarter of 2014,
represents an increase of 22 percent. Second quarter total revenue also
increased 22 percent to approximately $2,278 million compared to $1,873
million in the second quarter of 2014. For the same period, adjusted
diluted EPS increased 37 percent to approximately $1.23 from $0.90.
Adjusted diluted EPS for the second quarter of 2015 included a $0.06 per
share gain related to the sale of an equity investment upon the
completion of their acquisition by another company.
Based on U.S. GAAP (Generally Accepted Accounting Principles),
preliminary second quarter 2015 diluted EPS was approximately $0.43 per
diluted share. For the second quarter of 2014, diluted EPS was $0.72 per
diluted share. Second quarter 2015 GAAP EPS included increased expenses
for upfront collaboration payments.
2015 Guidance for Celgene
Reaffirming total net product sales to a range of $9 billion to $9.5
billion
Raising adjusted diluted EPS to a range of $4.75 to $4.85 from the
previous range of $4.60 to $4.75, an increase of approximately 29
percent over 2014 adjusted diluted EPS
GAAP diluted EPS is expected to be in the range of $2.43 to $2.71 from
the previous range of $2.97 to $3.19
2020 Long-term Financial Targets for Celgene
Increasing 2020 net product sales to exceed $21 billion, up from the
previous target of greater than $20 billion
Hematology franchise expected to exceed $14.8 billion
Oncology franchise expected to exceed $2.2 billion
I&I franchise now expected to exceed $4.0 billion, up from the
previous target of $3.0 billion
Adjusted diluted EPS is expected to exceed $13.00, up from the
previous target of $12.50
Fully diluted share count is expected to be approximately 830 million
About Ozanimod
Ozanimod is a selective immune-inflammatory modulator of the G
protein-coupled receptors sphingosine 1-phosphate 1 and 5, which are
part of the sphingosine 1-phosphate (S1P) receptor family. Treatment
with S1P receptor modulators interferes with S1P signaling and blocks
the response of lymphocytes (a type of white blood cell) to exit signals
from the lymph nodes, sequestering them within the nodes. The result is
a downward modulation of circulating lymphocytes and anti-inflammatory
activity by inhibiting cell migration to sites of inflammation.
About Receptos
Receptos is a biopharmaceutical company developing therapeutic
candidates for the treatment of immune and metabolic diseases. Receptos
lead program, Ozanimod, is a sphingosine 1-phosphate 1 and 5 receptor
small molecule modulator in development for immune-inflammatory
indications including IBD and RMS. Patents supporting Ozanimod were
exclusively licensed to Receptos from The Scripps Research Institute
(TSRI). Receptos is also developing RPC4046, an anti-interleukin-13
(IL-13) antibody for (EoE), an allergic/immune-mediated orphan disease,
as well as other pipeline and pre-clinical stage compounds.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through gene and
protein regulation. For more information, please visit .celgene.com.
Follow Celgene on Social Media: @Celgene,
Pinterest,
LinkedIn
and YouTube.
Conference Call and Webcast Information
Celgene will host a conference call today, July 14, to discuss the
strategic acquisition of Receptos at 5:30 p.m. EDT. The conference call
will be available by webcast on the Investor Relations page of Celgene’s
website, .Celgene.com.
An audio replay of the call will be available from midnight July 14,
2015 until midnight July 30, 2015. To access the replay in the U.S.,
dial (855) 859-2056; outside the U.S. dial (404) 537-3406. The
participant passcode is 81657332.
Additional Information about the Transaction and Where to Find It
The tender offer described herein has not yet commenced. The description
contained herein is for informational purposes only and is not an offer
to buy or the solicitation of an offer to sell any shares of
Receptos. At the time the tender offer is commenced, Celgene and its
wholly-owned subsidiary, Strix Corporation, intend to file with the U.S.
Securities and Exchange Commission (the “SEC”) a Tender Offer Statement
on Schedule TO containing an offer to purchase, a form of letter of
transmittal and other documents relating to the tender offer, and
Receptos intends to file a Solicitation/Recommendation Statement on
Schedule 14D-9 with respect to the tender offer. Celgene, Strix
Corporation and Receptos intend to mail these documents to the
stockholders of Receptos. THESE DOCUMENTS, AS EACH MAY BE AMENDED OR
SUPPLEMENTED FROM TIME TO TIME, WILL CONTAIN IMPORTANT INFORMATION ABOUT
THE TENDER OFFER AND RECEPTOS STOCKHOLDERS ARE URGED TO READ THEM
CAREFULLY WHEN THEY BECOME AVAILABLE. Stockholders of Receptos will be
able to obtain a free copy of these documents (when they become
available) and other documents filed by Receptos, Celgene or Strix
Corporation with the SEC at the website maintained by the SEC at .sec.gov.
Forward-Looking Statements
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
similar expressions. Forward-looking statements are based on
management s current plans, estimates, assumptions and projections, and
speak only as of the date they are made. Celgene and Receptos undertake
no obligation to update any forward-looking statement in light of new
information or future events, except as otherwise required by law.
Forward-looking statements involve inherent risks and uncertainties,
most of which are difficult to predict and are generally beyond the
control of either company, including the following: (a) the occurrence
of any event, change or other circumstance that could give rise to the
termination of the merger agreement; (b) the inability to complete the
transaction due to the failure to satisfy conditions to the transaction;
(c) the risk that the proposed transaction disrupts current plans and
operations; (d) difficulties or unanticipated expenses in connection
with integrating Receptos into Celgene; (e) the risk that the
acquisition does not perform as planned; and (f) potential difficulties
in employee retention following the closing of the transaction. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in the public
reports of each company filed with the SEC.
In addition to financial information prepared in accordance with U.S.
GAAP, this press release also contains adjusted financial measures that
Celgene believes provide investors and management with supplemental
information relating to operating performance and trends that facilitate
comparisons between periods and with respect to projected information.
These adjusted financial measures are non-GAAP and should be considered
in addition to, but not as a substitute for, the information prepared in
accordance with U.S. GAAP. Celgene typically excludes certain GAAP items
that management does not believe affect its basic operations and that do
not meet the GAAP definition of unusual or non-recurring items. Other
companies may define these measures in different ways. See the attached
Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP)
Diluted EPS for explanations of the amounts excluded and included to
arrive at Celgene’s adjusted EPS amounts for the three month period
ended June 30, 2015 and for the projected amounts for the year ending
December 31, 2015.
Celgene Corporation and Subsidiaries
Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP)
Diluted EPS
(Unaudited)
Three Months Ended
Twelve Months Ending
June 30, 2015
December 31, 2015
Range
Range
Low
High
Low
High
Estimated/projected diluted earnings per common share - GAAP
(1)
$
0.42
$
0.44
$
2.43
$
2.71
Per share impact of excluded items before tax:
Share-based compensation expense
(2)
0.18
0.18
0.71
0.68
Upfront collaboration expense
(1)(3)
0.69
0.69
1.40
1.29
Amortization of acquired intangible assets
(1)(4)
0.08
0.08
0.31
0.31
Change in fair value of contingent consideration
(1)(5)
(0.03
)
(0.05
)
0.07
0.05
Acquisition related charges
(1)(6)
-
-
0.09
0.03
Net income tax adjustments
(7)
(0.11
)
(0.11
)
(0.26
)
(0.22
)
Estimated/projected diluted earnings per common share - Adjusted
Approximately $ 1.23
$
4.75
$
4.85
In addition to financial information prepared in accordance with
U.S. GAAP, this press release also contains adjusted financial
measures that we believe provide investors and management with
supplemental information relating to operating performance and
trends that facilitate comparisons between periods and with respect
to projected information. These adjusted financial measures are
non-GAAP and should be considered in addition to, but not as a
substitute for, the information prepared in accordance with U.S.
GAAP. We typically exclude certain GAAP items that management does
not believe affect our basic operations and that do not meet the
GAAP definition of unusual or non-recurring items. Other companies
may define these measures in different ways.
Explanation of adjustments:
(1)
Our estimated/projected 2015 diluted EPS amounts do not include the
effect of any business combinations, collaboration agreements, asset
acquisitions, intangible asset impairments, or changes in the fair
value of our CVRs issued as part of the acquisition of Abraxis
BioScience Inc. (Abraxis) that may occur or be announced after this
press release.
(2)
Exclude share-based compensation expense.
(3)
Exclude upfront payment expense for research and development
collaboration arrangements.
(4)
Exclude amortization of intangible assets acquired in the
acquisitions of Pharmion Corp., Gloucester Pharmaceuticals, Inc.
(Gloucester), Abraxis and Celgene Avilomics Research, Inc. (Avila).
(5)
Exclude changes in the fair value of contingent consideration
related to the acquisitions of Gloucester, Abraxis, Avila and Nogra
Pharma Limited.
(6)
Exclude acquisition related charges related to the acquisition of
Receptos, Inc.
(7)
Net income tax adjustments reflect the estimated tax effect of the
above adjustments and the impact of certain other non-operating tax
adjustments, including the effects of acquisition related matters,
adjustments to the amount of unrecognized tax benefits, and an
adjustment related to the gain on the sale of an equity investment.
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