UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
SCHEDULE TO
Tender Offer Statement under Section 14(d)(1)
or 13(e)(1)
of the Securities Exchange Act of 1934
RECEPTOS,
INC.
(Name of Subject
Company (Issuer))
STRIX CORPORATION
(Offeror)
A Wholly Owned
Subsidiary of
CELGENE CORPORATION
(Parent of Offeror)
(Names of Filing
Persons (identifying status as offeror, issuer or other person))
COMMON STOCK,
$0.001 PAR VALUE
(Title of Class
of Securities)
756207106
(CUSIP Number
of Class of Securities)
Robert J. Hugin
Chairman and Chief Executive Officer
Celgene Corporation
86 Morris Avenue
Summit, New
Jersey 07901
(908) 673-9000
(Name, address,
and telephone numbers of person authorized
to receive notices
and communications on behalf of filing persons)
Copies to:
Robert A. Cantone,
Esq.
Daniel I. Ganitsky,
Esq.
Ori Solomon,
Esq.
Proskauer Rose LLP
Eleven Times
Square
New York, New
York 10036
(212) 969-3000
CALCULATION
OF FILING FEE
Transaction
Valuation |
Amount
of Filing Fee |
N/A* |
N/A* |
* A filing fee is not required in connection with this filing as
it relates solely to preliminary communications made before the commencement of a tender offer.
| o | Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting
fee was previously paid. Identify the previous filing by registration statement number, or the Form or Schedule and the date of
its filing. |
|
Amount Previously Paid: |
n/a |
Filing Party: |
n/a |
|
|
Form of Registration No.: |
n/a |
Date Filed: |
n/a |
|
| x | Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer. |
Check the appropriate boxes below to designate any transactions
to which the statement relates:
| x | third-party tender offer subject to Rule 14d-1. |
| o | issuer tender offer subject to Rule 13e-4. |
| o | going-private transaction subject to Rule 13e-3. |
| o | amendment to Schedule 13D under Rule 13d-2. |
Check the following box if the filing is a final amendment reporting
the results of the tender offer. o
If applicable, check the appropriate box(es) below to designate
the appropriate rule provision(s) relied upon:
| o | Rule 13e-4(i) (Cross-Border Issuer Tender Offer) |
| o | Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) |
This filing relates solely to preliminary communications
made before the commencement of a planned tender offer by Strix Corporation (“Purchaser”), a wholly owned subsidiary
of Celgene Corporation (“Celgene”), for all of the outstanding shares of common stock, par value $0.001 per share,
of Receptos, Inc. (“Receptos”), to be commenced pursuant to the Agreement and Plan of Merger, dated as of July 14,
2015, by and among Celgene, Purchaser and Receptos.
The tender offer described in the attached
exhibits 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 Purchaser 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, Purchaser 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 Purchaser with the SEC
at the website maintained by the SEC at www.sec.gov.
Exhibit Index
Exhibit |
|
Description |
|
|
|
99.1 |
|
Investor Presentation. |
99.2 |
|
Joint Press Release, dated July 14, 2015. |
|
|
|
Exhibit 99.1
Celgene Announces Acquisition of Receptos July 14, 2015
Agenda 2 Bob Hugin, Celgene Chairman & Chief Executive Officer • Strategic Overview Scott Smith, Celgene President of Global Inflammation and Immunology • Enhancing the I&I Franchise Peter Kellogg, Celgene Executive Vice President & Chief Financial Officer • Transaction Overview Mark Kreston, Celgene Corporate Vice President, Global Marketing I&I • Ozanimod Opportunity in IBD and MS
Forward Looking Statements and Adjusted Financial Information Thi s presentatio n contain s forward - lookin g statements , whic h ar e generall y s tatement s tha t ar e not historica l facts . Forward - lookin g s tatement s ca n b e identifie d b y th e word s “ expects, ” “anticipates,” “believe s, ” “ intends ,” “esti m ate s, ” “p la n s ,” “will , ” “outlook ” an d simila r ex pressions . F orward - lookin g statement s ar e base d o n m anagemen t ’ s curren t plans , estimates , assumption s a n d projections , and spea k onl y as o f th e dat e the y ar e m ade . W e underta ke n o obligatio n to updat e an y forward - looking statemen t in ligh t o f new i nformatio n o r futur e eve n ts , e xcep t as o therwis e require d b y la w . Forward - lookin g s tatement s i nvolv e inheren t r isk s an d unce r tainties , m os t of whic h ar e di f f icul t to predic t and ar e generall y beyon d ou r contro l . Actual result s o r outcome s m ay di f fe r m aterially from thos e im pl ied b y th e f orward - lookin g s tatement s a s a resul t o f th e i m pac t o f a nu m be r o f factors , man y o f which ar e discusse d in m or e detai l in ou r Annua l Repo r t on F orm 10 - K an d ou r othe r report s f iled wit h the Securities and Exchange Commission . In additio n to unaudite d financia l informatio n prepare d in accordanc e wit h U . S . GAA P , this presentatio n also c ontain s adjuste d f inancia l measure s tha t w e beli e v e provid e in vestor s and managemen t wit h supplementa l informatio n relatin g to operatin g performanc e an d trend s t hat facilitate c o m parison s betwee n period s an d wit h respec t to projecte d infor m ation . Thes e adjusted measure s ar e no n - GAAP an d should b e considere d in additio n t o , bu t no t as a s ub stitute fo r , the informatio n prepare d in accordanc e wit h U . S . GAA P . W e t ypicall y exclud e certai n GAA P i tem s that managemen t d oe s no t believ e a f f e c t ou r basi c operation s an d tha t d o no t mee t th e GAA P definition o f unusua l o r non - recurrin g i tems . Othe r companie s ma y defin e t hes e m ea s ure s in di f feren t ways . Furthe r informatio n relevan t to th e i nterpretatio n o f a djuste d f inancia l m easur e s, and reconciliations of thes e a dj u s te d fi nan cial measure s to th e m o s t compar able G AAP measures , ma y be f oun d on our website at ww w . Celgene . com in the “Investor Relations” section . 3
Additional Information on the Tender Offer 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 www.sec.gov . In addition, stockholders will be able to obtain a free copy of these documents (when they become available) from the information agent named in the offer to purchase or from Celgene. 4
Agenda 5 Bob Hugin, Celgene Chairman & Chief Executive Officer • Strategic Overview Scott Smith, Celgene President of Global Inflammation and Immunology • Enhancing the I&I Franchise Peter Kellogg, Celgene Executive Vice President & Chief Financial Officer • Transaction Overview Mark Kreston, Celgene Corporate Vice President, Global Marketing I&I • Ozanimod Opportunity in IBD and MS
Our Mission and Vision Celgene is building a preeminent global biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for unmet medical needs in cancer and immune - inflammatory diseases 6
OUR FOCUS: Executing on Five Strategic Imperatives Operational excellence Capitalizing on strength in Hematology Expanding the Oncology franchise Sustaining innovation and long - term growth Building an Immunology & Inflammation franchise 7
Operational Excellence • Exceptional Q2:15 Financial Performance (preliminary) – Total Revenue of approximately $2.28 billion, 22% year - over - year increase – Adjusted EPS of approximately $1.23, including a $0.06 gain on the sale of an equity investment, 37% year - over - year increase • Significant Operational Accomplishments in the H1 of 2015 – Six approvals in major markets – Advancing 15 pivotal trials across the in - line brands and pipeline portfolio • Strong Momentum Expected Through the Remainder of 2015 – Total Net Product Sales between $9.0 to $9.5 billion, in - line with earlier FY guidance – Raising adjusted EPS guidance to $4.75 - $4.85, inclusive of the Receptos impact, compared to earlier guidance of $4.60 - $4.75 Delivering Financial & Operational Performance 8
Sustaining Innovation and Long - Term Growth • Added Significant Next - generation Growth Drivers – Deals with AstraZeneca, Juno, and Receptos enhance our existing pipeline by adding the potential of 4 product approvals in multiple diseases by 2020 – Accelerated revenue and earnings growth expected beyond 2020 • Expanded Our Immuno - Oncology Foundation – AstraZeneca and Juno collaborations are highly complementary – Comprehensive strategy activating innate and adaptive immunity • Enhancing Our I&I Franchise with the Receptos Acquisition – Ozanimod is a strong strategic fit with blockbuster potential – Robust combined portfolio addressing $ 70B marketplace with up to 10 indications Investing in the Future from a Position of Strength 9
x Leverages existing I&I capabilities and future IBD commercial infrastructure x Neutral to adjusted EPS in 2018; accretive beginning in 2019 x Raising 2020 targets to $ 21B+ in revenue (+$1B) & $13.00+ in adjusted EPS (+$0.50) Financially Compelling Ozanimod Is a Strong Strategic Fit with Significant Potential 10 x Potential best - in - class profile demonstrated in ulcerative colitis (UC) and multiple sclerosis (MS) x Phase III trials in UC and RMS underway; data expected beginning in H1:17 with first approvals in 2018 x Expected peak sales of $4 to $6 billion with intellectual property protection extending to 2030+ High Potential Therapy x Established mechanism of action with broad applicability across a range I&I diseases x Potential disruptive oral therapy for chronic care markets x Enhances our inflammatory bowel disease (IBD) portfolio Strong Strategic Fit x Complementary to OTEZLA ® , GED - 0301 and CC - 220 x Potential for paradigm - changing early utilization in markets with high unmet medical need x Multi - indication potential including Crohn’s disease (CD), lupus and psoriasis Well - Aligned with Existing Pipeline
Agenda 11 Bob Hugin, Celgene Chairman & Chief Executive Officer • Strategic Overview Scott Smith, Celgene President of Global Inflammation and Immunology • Enhancing the I&I Franchise Peter Kellogg, Celgene Executive Vice President & Chief Financial Officer • Transaction Overview Mark Kreston, Celgene Corporate Vice President, Global Marketing I&I • Ozanimod Opportunity in IBD and MS
Receptos is a Strong Strategic Fit for Celgene I&I Disruptive I&I Products • Ozanimod is a potential best - in - class oral S1P receptor modulator in late - stage development presenting a $4B - $6B peak sales opportunity • Ozanimod advancing in Phase III for Ulcerative Colitis and Relapsing Multiple Sclerosis with tremendous potential across multiple indications • Second product candidate, RPC4046, an IL - 13 antibody in Phase II for Eosinophilic Esophagitis, an orphan disorder with no FDA approved drugs Robust Ozanimod Clinical Data • Phase II TOUCHSTONE trial in UC, met key clinical and endoscopic endpoints for both induction and maintenance • Phase II RADIANCE trial in RMS, met the primary efficacy endpoint and all key secondary endpoints • Potential to offer an improved cardiac profile, reduced hepatoxicity and faster lymphocyte recovery versus currently marketed S1P drugs Differentiated Asset Targeting Large Markets • IBD is a $ 9 B market today with very few effective treatment options, especially for moderate - to - severe disease • Ozanimod could be the first S1P receptor modulator approved for IBD • RMS is a $20B market today and Ozanimod has the potential to be highly differentiated versus current therapies 12 Receptos Enhances our I&I Franchise with Additional Cornerstone Product
Programs and Indications Pre - Clinical Phase I Phase II Phase III Reg. Approval OTEZLA (PDE4 inhibitor) Psoriatic Arthritis Psoriasis Beh ç et Syndrome Ankylosing Spondylitis Atopic Dermatitis Ulcerative colitis GED - 0301 (Smad7 antisense oligo) Crohn’s Disease Ulcerative Colitis (planned) Ozanimod (S1PR modulator) Relapsing Multiple Sclerosis Ulcerative Colitis Crohn’s Disease (planned) RPC 4046 (IL - 13 inhibitor) 1 Eosinophilic Esophagitis Sotatercept (ACT2RB fusion protein) Renal Anemia / Bone CC - 292 (BTKi) B - Cell Mediated Disease/ RA CC - 220 (CELMod) Lupus CC - 90001 (JNK1i) IPF / Liver Fibrosis CC - 90005 ( PKC - θ i) Psoriasis/ other indications GLP - 1 receptor modulator Type 2 Diabetes Combined Robust and Deep I&I Pipeline 13 Celgene existing Receptos 1 Under co - development option with AbbVie
Phase III Ozanimod Data Expected Beginning in H1:17 14 • RADIANCE: Phase II / III trial in R elapsing Multiple Sclerosis – Enrollment completed in March 2015 – Data expected in H1:17 • SUNBEAM: Phase III trial in Relapsing Multiple Sclerosis – Enrollment initiated December 2014 – Data expected in H1:17 • TRUE NORTH: Phase III trial in Ulcerative Colitis – Enrollment initiated in July 2015 – Data expected in 2018 Ozanimod: Key Expected Clinical Milestones
Accelerating Momentum in the I&I Portfolio Celgene existing Receptos 15 1 Under co - development option with AbbVie Multiple Blockbuster Products Expected in I&I Significant Growth through 2020 and beyond OTEZLA ® PsA / Psor 2014 Ozanimod RMS 2018E Ozanimod UC 2019E GED - 0301 CD 2019E
Celgene I&I Targets Sizable Evolving Markets with a Portfolio of Disruptive Oral Therapies 16 Celgene I&I Portfolio Rheumatology Dermatology Gastroenterology / IBD Neuro - Inflammation Therapeutic Area Market Size ($B) 2014E 2020E $27 $34 $11 $17 $9 $15 $20 $27 Total ($B) $67 $93 Targeted Indications Products • PsA • Behçet’s • AS • SLE • Sjogrens • Psoriasis • Atopic Dermatitis • CD • UC • EoE • RMS CC - 220 Ozanimod Ozanimod GED - 0301 Ozanimod RPC - 4046 Ozanimod The Celgene I&I portfolio will target the majority of a $90 - $100B market in 2020 Footnote: Expansion of Ozanimod in Rheumatology and Dermatology planned Source : Evaluate Pharma
Agenda 17 Bob Hugin, Celgene Chairman & Chief Executive Officer • Strategic Overview Scott Smith, Celgene President of Global Inflammation and Immunology • Enhancing the I&I Franchise Peter Kellogg, Celgene Executive Vice President & Chief Financial Officer • Transaction Overview Mark Kreston, Celgene Corporate Vice President, Global Marketing I&I • Ozanimod Opportunity in IBD and MS
Ozanimod: Potential Best - in - Class Oral S1PR Modulator Transformational Potential in UC, MS and Beyond • Highly selective for S1P1 & S1P5 • Negligible S1P3 activity = less CV tox • PK – delayed C max , T 1/2 , V d • No pro - drug Dose - Attuned Titration Schedule Intrinsic Properties: Product Attributes: Treatment Benefits: Potential for Improved Cardiac Profile (HR, QTc) Potential for Reduced Hepatotoxicity Rapid Lymphocyte Recovery MS (Multiple Sclerosis) UC (Ulcerative Colitis) CD (Crohn’s Disease) SLE (Systemic Lupus Erythematosus) AD (Atopic Dermatitis) Psoriasis Broad Applications for Clinical Development 18
Ozanimod: A Potentially Transformational Profile in UC Ozanimod Induction of Remission and Response Mucosal Healing Once - daily Oral Dosing AEs & SAEs Similar to Placebo Rapid Onset of Efficacy 32 - Week Maintenance 19 x Novel oral treatments x Effective treatments to induce clinical response and to maintain remission x Therapies that are well tolerated with limited side effects x Safe (non - immunosuppressive ) and effective therapy; reduction of corticosteroid use x Alternative disruptive MOAs Unmet Needs in IBD Differentiated Clinical Profile Current profile based on Phase II
Tremendous Opportunity for Ozanimod to Disrupt the UC Treatment Paradigm Expected Positioning of UC Treatments 1 st line treatment 2 nd line treatment 3rd line treatment Last line treatment 5 - Aminosalicylates Immunosuppressants and Corticosteroids Tysabri ® Ozanimod Remicade ® Humira ® Entyvio ® 45% 37% 18% Majority of >1.3 million Patients with UC are Moderate to Severe Potential to be used as first line drug of choice in moderate to severe UC patients 20 55% Mild Moderate Severe
6.2% 9.3% 8.5% 16.4% 16.5% 17.3% 0% 5% 10% 15% 20% Ozanimod Wk 8 Phase II Humira Wk 8 Phase III Ozanimod Wk 32 Phase II Humira Wk 52 Phase III TOUCHSTONE Trial Results Reveal Transformational Potential for Ozanimod in the Treatment of Moderate - to - Severe UC • Efficacy: – Met primary efficacy and all secondary endpoints for patients on 1 mg dose after 8 weeks of treatment (induction) – Met primary efficacy and all secondary endpoints for patients on 1 mg dose after 32 weeks of treatment (maintenance) • Safety: G enerally favorable and consistent with prior studies – Incidence of adverse events across active treatment groups and placebo appeared similar – No new safety signals observed – Changes in heart rate generally modest during first 6 hours after administration – Rates of liver enzyme elevations observed were low Placebo Ozanimod 1.0mg Humira All key endpoints achieved Data presentation expected in H2 21 Cross Trial Comparison with Humira in UC
x Therapies that offer improved disease control for relapsing forms of MS x Additional safe and well - tolerated oral therapies x Therapies appropriate for long - term use x Agents that halt and / or reverse disability Unmet Needs in RMS Differentiated Clinical Profile Current profile based on Phase II Ozanimod Addresses Significant Unmet Medical Needs in Relapsing Multiple Sclerosis 22 Ozanimod Reduction in GdE lesions Favorable Cardiac Profile (HR, QTc ) Once - daily Oral Dosing Generally Well Tolerated Reduced Annualized Relapse Rate Favorable Hepatotox
Orals to Represent 60 - 70% of the $27B MS Market in 2020 $0 $15 $494 $1,204 $3,029 $5,957 $17,500 $0 $5,000 $10,000 $15,000 $20,000 2009 2010 2011 2012 2013 2014 2020E Ozanimod: Best - in - Class S1P1 Potential for Utilization in First - Line RMS * = Oral treatment Newly diagnosed 1 st line treatment • Cycling • New therapies will be introduced 2 nd line treatment • 1 st line failures • Tolerability issues Last line treatment • Salvage treatment Beta Interferons / Copaxone ® Ozanimod * Gilenya ® * Aubagio ® * Daclizumab Lemtrada™ Ocrelizumab Tysabri ® JC virus negative patients Tecfidera ® * 23 Expected Positioning of RMS Treatments Explosive growth expected in MS oral revenues ($mm) Source : Company reports and Evaluate Pharma
Ozanimod Phase II Efficacy Comparison to GILENYA ® and TECFIDERA ® 82% 55% 90% 53% 74% 44% 86% 31% 86% 53% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% GD+ Lesion Reduction* ARR Reduction* GILENYA FREEDOMS (0.5mg qd) TECFIDERA DEFINE (240mg bid) TECFIDERA CONFIRM (240mg bid) Ozanimod 0.5mg Phase II * Reduction vs. Placebo 24 Cross Trial Comparisons of Select Oral MS Therapies
Agenda 25 Bob Hugin, Celgene Chairman & Chief Executive Officer • Strategic Overview Scott Smith, Celgene President of Global Inflammation and Immunology • Enhancing the I&I Franchise Peter Kellogg, Celgene Executive Vice President & Chief Financial Officer • Transaction Overview Mark Kreston, Celgene Corporate Vice President, Global Marketing I&I • Ozanimod Opportunity in IBD and MS
Acquisition leverages our commercial structure / expertise, further diversifies revenue and enhances long - term growth Transaction Overview 26 Consideration Financing Financial benefits Other • All - cash consideration of $232 per share • Total transaction value of $7.2 billion, net of cash • Sources of cash: mix of new debt and cash • Committed bridge financing in place • Plan to access debt capital markets for permanent funding • Adjusted EPS impact: $ 0.40 to $ 0.25 dilutive in 2016 and 2017, respectively; break - even in 2018; accretive beginning in 2019 • Raising 2020 targets: total net product sales $21B +; adjusted EPS $13.00+ • Significant growth driver beyond 2020: peak Ozanimod sales of $4 to $6 billion • Strong combined balance sheet • Resulting capital structure consistent with financial strategy and investment grade profile • Transaction expected to close in Q3:15 • Maintains financial flexibility for additional value creating transactions and share buyback
Celgene Announces Acquisition of Receptos July 14, 2015
Reconciliation Tables
Exhibit 99.2
Celgene to Acquire Receptos,
Advancing Leadership in
Immune-Inflammatory
Diseases
Significantly Enhances
Celgene’s I&I Franchise with the Addition of Ozanimod, Potentially a Best-in-Class Oral Agent in Phase III Trials
for Inflammatory Bowel Disease and Multiple Sclerosis
Accelerates Growth Beginning
in 2019; Significant Growth Driver Beyond 2020 with Expected Ozanimod Peak Annual Sales of $4 - $6 Billion
Raising 2020 Financial Targets
to Exceed
$21 Billion in Total Net Product
Sales and Adjusted EPS to Exceed $13.00
Raising 2015 Adjusted Diluted EPS Guidance
Based on Strong Preliminary
Second Quarter Results
SUMMIT, NJ and SAN DIEGO, CA –
(July 14, 2015) – Celgene Corporation (NASDAQ: CELG) and Receptos, Inc. (NASDAQ:
RCPT) today announced the signing of a definitive agreement in which Celgene has agreed to acquire Receptos. 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). 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. The phase III
TRUE NORTH trial in UC is currently underway with data expected in 2018. 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. 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: Behçet’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 Board 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 |
| o | Hematology franchise expected to exceed $14.8 billion |
| o | Oncology franchise expected to exceed $2.2 billion |
| o | 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 www.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 pm EDT. The conference call will be available
by webcast on the Investor Relations page of Celgene’s website, www.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 www.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 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. 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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