- Filing of certain prospectuses and communications in connection with business combination transactions (425)
20 Julho 2011 - 9:01AM
Edgar (US Regulatory)
Filed by Allos Therapeutics, Inc.
Pursuant to Rule 425 Under the Securities Act of 1933
And Deemed Filed Pursuant to Rule 14a-12
Under the Securities Exchange Act of 1934
Subject Company: Allos Therapeutics, Inc.
Commission File No. 000-29815
This filing relates to the proposed merger of Allos Therapeutics, Inc., a Delaware corporation (Allos) with Alamo Acquisition Sub, Inc. (Merger Sub), a Delaware corporation and subsidiary of AMAG Pharmaceuticals, Inc., a Delaware corporation (AMAG), pursuant to the terms of that certain Agreement and Plan of Merger and Reorganization, dated as of July 19, 2011, by and among Allos, AMAG and Merger Sub.
Additional Information and Where You Can Find It
This report does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. The proposed merger between AMAG and Allos will be submitted to the respective stockholders of AMAG and Allos for their consideration.
AMAG will file a Registration Statement on Form S-4 containing a joint proxy statement/prospectus of Allos and AMAG and other documents concerning the proposed acquisition with the SEC. Investors are urged to read the joint proxy statement/prospectus when it becomes available and other relevant documents filed with the SEC because they will contain important information. Security holders may obtain a free copy of the proxy statement/prospectus (when it is available) and other documents filed by Allos and AMAG with the SEC at the SECs website at www.sec.gov. The joint proxy statement/prospectus and other documents may also be obtained for free by contacting Allos Investor Relations by e-mail at investorrelations@allos.com, by telephone at (303) 426-6262 or by mail at Investor Relations, Allos Therapeutics, Inc., 11080 CirclePoint Road, Suite 200, Westminster, CO 80020 or by contacting AMAGs Investor Relations by e-mail at asullivan@amagpharma.com, by telephone at (617) 498-3303 or by mail at Investor Relations, AMAG Pharmaceuticals, Inc., 100 Hayden Avenue, Lexington, MA 02421.
Allos, AMAG, certain of their respective directors, executive officers, members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitation of proxies in connection with the proposed merger. Information regarding Allos directors and executive officers and their beneficial ownership of Allos common stock is also set forth in Allos annual proxy statement on Schedule 14A filed with the SEC on April 29, 2011. This document is available free of charge at the Security and Exchange Commissions website at www.sec.gov or by going to Allos Investors page on its corporate website at www.allos.com. Information concerning AMAGs directors and executive officers and their beneficial ownership of AMAGs common stock is set forth in AMAGs annual proxy statement on Schedule 14A filed with the Security and Exchange Commission on April 18, 2011. This document is available free of charge at the Security and Exchange Commissions website at www.sec.gov or by going to AMAGs Investors page on its corporate website at www.amagpharma.com. Additional information regarding the persons who may, under the rules of the Security and Exchange Commission, be deemed participants in the solicitation of proxies in connection with the proposed merger, and a description of their direct and indirect interests in the proposed merger, which may differ from the interests of Allos investors or AMAGs investors generally, will be set forth in the joint proxy statement/prospectus when it is filed with the Security and Exchange Commission.
Forward-Looking Statements
This report contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Terminology such as may, will, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, potential, continue, and other similar terminology or the negative of these terms, are intended to identify such forward-looking statements, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These statements are not guarantees of future performance, involve risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. For example, if Allos or AMAG does not receive its respective required stockholder approval or the parties fail to satisfy other conditions to closing, the transaction may not be consummated. In any forward-looking statement in which AMAG or Allos expresses an expectation or belief as to future results, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: failure of Allos or AMAG stockholders to approve the proposed transaction; the challenges and costs of closing, integrating, restructuring and achieving anticipated synergies; disruptions to the businesses of Allos and AMAG during the pendency of the merger and during the realization of the cost synergies, including diminished performance by the commercial organizations due to planned reductions in the size of the sales and marketing organization at the combined company; the ability to retain key employees; and other economic, business, competitive, and/or regulatory factors affecting the businesses of Allos and AMAG generally, including those set forth in the filings of Allos and AMAG with the SEC, especially in the Risk Factors section of Allos Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 filed with the SEC on May 10, 2011, the Risk Factors section of AMAGs Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 filed with the SEC on May 9, 2011, and in Allos and AMAGs other periodic reports and filings with the Security and Exchange Commission. Allos cautions investors not to place undue reliance on the forward-looking statements contained herein. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.
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I N V E S T O R
P R E S E N T A T I O N AMAG Pharmaceuticals and Allos Therapeutics to Merge
p g July 20, 2011 Creates Company With Strengthened Commercial Portfolio 1
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Forward Looking
Statements This communication contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Terminology such as may, will, should,
expects, intends, plans, anticipates, believes, estimates,
predicts, j i l i d h i il i l h i f h i d d id if hf dl ki 2
projects, potential, continue, and other similar terminology or the
negative of these terms, are intended to identify such forward-looking
statements, but their absence does not mean that a particular statement is
not forward-looking. Such forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that may cause
actual results to differ materially from those anticipated by the
forward-looking statements. These statements are not guarantees of future
performance, involve risks, uncertainties and assumptions that are difficult
to predict, and are based upon assumptions as to future events that may not
prove accurate. Examples of such forward looking statements include Allos and
AMAGs expectations with respect to the synergies, costs and other
anticipated financial impacts of the proposed transaction; future financial
and operating results of the combined company, including potential future
revenues, milestone payments and royalties; the combined company's plans,
objectives, expectations and intentions with respect to future clinical
development and marketing programs; expectations and intentions with respect
to future operations; approval of the proposed transaction by requisite
stockholders; the satisfaction of the closing conditions to the proposed
transaction; and the timing of the completion of the proposed transaction. In
any forwardlooking statement in which AMAG or Allos expresses an expectation
or belief as to future results, such expectation or belief is expressed in
good faith and believed to have a reasonable basis, but there can be no
assurance that the statement or expectation or belief will result or be
achieved or accomplished. The following factors, among others, could cause
actual results to differ materially from those described in the
forwardlooking statements: failure of Allos or AMAG stockholders to approve
the proposed transaction; the challenges and costs of closing the proposed
transaction, integrating the two companies, restructuring the combined
company; the possibility that the expected synergies will not be realized, or
will not be realized within the expected time period; the possibility that
future clinical development and marketing programs may be delayed or revised;
the ability to retain key employees; and other economic, business,
competitive, and/or regulatory factors affecting the businesses of Allos and
AMAG generally, including those set forth in the filings of Allos and AMAG with
the Securities and Exchange Commission, especially in the g y, g g g , p y
Risk Factors section of Allos Quarterly Report on Form 10-Q for the
quarter ended March 31, 2011 filed with the SEC on May 10, 2011, the Risk
Factors section of AMAGs Quarterly Report on Form 10-Q for the quarter
ended March 31, 2011 filed with the SEC on May 9, 2011, and in Allos and
AMAGs other periodic reports and filings with the SEC. Allos and AMAG
cautions investors not to place undue reliance on the forward-looking
statements contained herein. All forward-looking statements are based on
information currently available to Allos and AMAG on the date hereof, and
Allos and AMAG undertake no obligation to revise or update these
forward-looking statements to reflect events or presentation required by law
circumstances after the date of this presentation, except as law.
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Important
Merger Information and Additional Information and Where to Find It This
communication does not constitute an offer to sell or the solicitation of an
offer to buy any securities or a solicitation of any vote or approval. The
proposed merger between AMAG and Allos will be submitted to the respective
stockholders of 3 AMAG and Allos for their consideration. AMAG will file a
Registration Statement on Form S-4 containing a joint proxy
statement/prospectus of Allos and AMAG and other documents concerning the
proposed acquisition with the Securities and Exchange Commission (the SEC).
Investors are urged to read the joint proxy statement/prospectus when it
becomes available and other relevant documents filed with the SEC because
they will contain important information. Security holders may obtain a free
copy of the proxy statement/prospectus (when it is available) and other
documents filed by Allos and AMAG with the SEC at the SECs website at
www.sec.gov. The joint proxy statement/prospectus and other documents may
also be obtained for free by contacting Allos Investor Relations by e-mail
at investorrelations@allos.com, by telephone at (303) 426-6262 or by mail at
Investor Relations, Allos Therapeutics, Inc., 11080 CirclePoint Road, Suite
200, Westminster, CO 80020 or by contacting AMAGs Investor Relations by
e-mail at cmiceli@amagpharma.com, by telephone at (617) 498-3361 or by mail
at Investor Relations, AMAG Pharmaceuticals, Inc., 100 Hayden Avenue,
Lexington, MA 02421. Allos, AMAG, certain of their respective directors,
executive officers, members of management and employees may, under the rules
of the SEC, be deemed to be participants in the solicitation of proxies in
connection with the proposed merger. Information regarding Allos directors
and executive officers and their beneficial ownership of Allos common stock
is also set forth in Allos annual proxy statement on Schedule 14A filed with
the SEC on April 29, 2011. This document is available free of charge at the
SECs website at www.sec.gov or by going to Allos Investors page on its
corporate website at www.allos.com. Information i AMAG di d i ffi d h i b fi
i l hi f AMAG k i f h i AMAG concerning AMAGs directors and executive
officers and their beneficial ownership of AMAGs common stock is set forth
in AMAGs annual proxy statement on Schedule 14A filed with the SEC on April
18, 2011. This document is available free of charge at the SECs website at
www.sec.gov or by going to AMAGs Investors page on its corporate website at
www.amagpharma.com. Additional information regarding the persons who may,
under the rules of the SEC, be deemed participants in the solicitation of
proxies in connection with the proposed merger, and a description of their
direct and indirect interests in the proposed merger, which may differ from
the interests of Allos AMAGs generally Allos investors or AMAG s investors
generally, will be set forth in the joint proxy statement/prospectus when it
is filed with the SEC.
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Merger
Highlights 4 Terms Stock for stock transaction 0 1282 AMAG shares for
each Allos Allos stockholders will receive 0.1282 share held; total equity
value of approximately $686 million Ownership at Closing AMAG 61% / Allos
39% Cash Position 30 373 7M; June 30, 2011 combined cash and investments of
$373.7M; no debt Combined companys cash position expected to be sufficient
to reach cash flow positive status Board of Directors Total of 9 Directors;
5 from AMAG, 4 from Allos Chairman: Michael Narachi Director: Paul L.
Berns CEO, Headquarters and Name Brian J.G. Pereira, MD, Chief Executive
Officer Headquarters: Lexington, MA N q g , M Combined company expected
to be renamed to reflect strategic focus Closing Conditions Subject to
customary closing conditions and regulatory approval Stockholder approval
for both Allos and AMAG Transaction Close Expected in fourth quarter 2011
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Financial and
Strategic Benefits of Merger . Combined company will have a diversified
portfolio of commercial products 5 focused on high-potential markets with
overlapping customer segments . FERAHEME® (ferumoxytol injection) for the
treatment of iron deficiency anemia (IDA) in adult patients with chronic
kidney disease (CKD) . FOLOTYN® (pralatrexate injection) for the treatment
of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) .
Global development programs expected to drive expanded market opportunities
for both brands . Combined company expected to realize annual synergies of
$55 million to $60 million from cost reductions . Majority to be realized in
the first fiscal year after close . Strong balance sheet for business
reinvestment and further portfolio diversification
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Two Commercial
Products with Compelling Value FERAHEME FOLOTYN Description . Therapeutic
iron formulation delivered via intravenous (IV) injection . U S l J . Folate
analogue metabolic inhibitor delivered via intravenous (IV) injection . U S l
S t b Propositions 6 U.S. approval June 2009 U.S. approval September 2009
Labeled Indication . Approved for the treatment of iron deficiency anemia
(IDA) in adult patients with chronic kidney disease (CKD) . Approved for the
treatment of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL)
2nd line plus Label . Ongoing development program for the . Two planned
post-approval global Phase 3 registration studies Expansion Opportunities
treatment of IDA regardless of the underlying cause . Two Phase 3 studies
ongoing . Completion of enrollment expected in 2011 . sNDA submission
expected in 2012 . Front-line PTCL . SPA in place, initiation of enrollment
expected in 2011 . Combination study in relapsed or refractory cutaneous
T-cell lymphoma (CTCL) . Completion of Phase 1 maximum tolerated dose (MTD)
study expected in 2011; initiation of Phase 3 study p y p ; y expected in
2012 Commercial Rights . Retains U.S. commercialization rights . Ex-U.S.
rights licensed to Takeda and 3SBio (China) . EU and Canadian regulatory
decisions for . Retains U.S. / Canada commercialization rights . ROW rights
licensed to Mundipharma . EU regulatory decision for R/R PTCL expected in
early 2012; launch in 2012 IDA in CKD expected in 2011; launches in 2012 .
FERAHEME has patent protection through 2020, potentially longer with
extensions . FOLOTYN has patent protection through 2017; potentially to 2022
with extensions; T-cell use patent through 2025 Value P iti . Demonstrated
clinical efficacy . F bl d i hdl . Broad indication in R/R PTCL subtypes . D
t td d bl lii l Proposition Favorable dosing schedule . Full one gram dose of
iron delivered in 2 visits . Rapid IV injection Demonstrated durable clinical
responses . Rapid onset of action . Predictable and manageable safety profile
. Convenient 3 to 5 minute IV push
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FERAHEME and
FOLOTYN Have Attractive Opportunities for Continued Growth and Value
Creation, Sharing Many Common Call Points Market detail Non-dialysis CKD
Incidence 7 . The overall U.S. non-dialysis IV iron market is estimated to be
$400 million . 1.6 million Americans are estimated to have non-dialysis
dependent CKD and IDA, a fraction of which are treated . IV iron for CKD is
administered at hematology / oncology infusion center, hospitals and
nephrology clinics RAHEME 18 million adults with stage 3 & 4 CKD1 3
million are anemic (15%) p gy . AMAG estimates that approximately 50% of
overall IV iron is used in the treatment of CKD Sources: 1NDD-CKD: Coresh J,
et al. Prevalence of Chronic Kidney Disease in the United States. JAMA,
November 2007. DD-CKD. 2Fishbane, S. et al. Iron Indicies in CKD in the
NHANES 1988-2004,CJASN, Jan. 2009, Vol 4, No. 1 FER Market detail Peripheral
T-Cell Lymphoma High Unmet Need >1.6 million2 have iron deficiency
anemia (>50%) T . The total U.S. market for second line peripheral T-cell
lymphoma is estimated to be $400 million . The total U.S. relapsed or
refractory PTCL treatable population is estimated to be approximately 10,000
patients M j i f i l i l h f di i f TYN 5,900 newly diagnosed patients 4,900
2nd line . Majority of PTCL patients ultimately have refractory disease to a
variety of treatments, such as CHOP . PTCL patients are treated by
hematologist / oncologist . Treatment is administered either in the
hematology / oncology infusion center, community clinics, academic cancer
centers, and hospitals FOLOT 5,100 3rd line plus M k t S PTCL Market Sources
1 Incidence and 2nd line patients includes all PTCL subtypes; estimated using
market research studies, secondary reports, independent 3rd party research,
oncology benchmarks; 2010 U.S. estimates based on Allos analysis 2 The
Non-Hodgkin's Lymphoma Classification Project. A clinical evaluation of the
International Lymphoma Study Group classification of non-Hodgkin's lymphoma.
Blood. 1997;89(11):3909-3908. 3 Hennessy BT, Hanrahan EO, Daly PA.
Non-Hodgkin lymphoma: an update [review]. Lancet Oncol. 2004;5(6):341-353. 4
O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell lymphomas
[review]. Curr Oncol Rep. 2008;134(5):202-207. 5 Market size based on range
of average single agents used off-label in U.S. - This is not a FOLOTYN
forecast.
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Strengthened
Commercial Company Expected to Leverage Customer Relationships for Brands .
Products: FERAHEME and FOLOTYN 8 . Address attractive markets with targeted
sales force . Improved share of voice . Target call points include hematology
/ oncology infusion centers, g p gy/ gy , community clinics, academic cancer
centers, hospitals & strategic nephrology customers . Market Opportunity:
Hematology / Oncology Sites of Care . Facilitates increased brand awareness
and market penetration . Optimizes promotional selling time through
two-product call across healthcare provider continuum (physicians, nurses, h
i ffi d i i ) pharmacists, office administrators, etc.) . Enhances visibility
of both products through existing KOL relationships
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Global
Development Programs Expected to Drive Expanded Market Opportunities .
Strategic collaborations outside the U.S. with industry leaders with T k d
i l U S i d 3Sbi i Chi f FERAHEME d 9 Takeda in several ex-U.S. regions and
3Sbio in China for FERAHEME, and Mundipharma for FOLOTYN ex-U.S. and Canada .
FERAHEME marketing applications are under review in the EU, Canada and
Switzerland for the treatment of IDA in adult CKD patients, regulatory p g y
decisions expected in the EU and Canada in 2011 and in Switzerland in 2012 .
FERAHEME is being evaluated in a global registration program for a broad IDA
indication; completion of enrollment is expected by year end 2011 . FOLOTYN
marketing application is under review in the EU for the treatment of patients
with relapsed or refractory PTCL, regulatory decision in EU expected in early
2012 . FOLOTYN will be evaluated in two Phase 3 global registration studies
exploring its activity in first-line PTCL and relapsed or refractory
cutaneous T-cell lymphoma
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Multiple
Milestones Provide Future Growth Opportunities 2H 2011 Mil t 2012 Mil t 10 .
CHMP recommendation expected for EU MAA for IDA in CKD D i i t d di C di .
sNDA submission to FDA and EMA for broad IDA indication Milestones Milestones
EME ME . Decision expected regarding Canadian regulatory application for IDA
in CKD . Complete enrollment of IDA Phase 3 trials . EU CKD launch . Canadian
CKD launch . Swiss CKD Decision / Launch FERAHE FERAHEM . Pursue EU
regulatory approval for R/R PTCL . Initiate Phase 3 study in first line PTCL;
SPA agreement with FDA in place . Decision expected in EU for R/R PTCL in
early 2012 . EU R/R PTCL launch TYN TYN . Seek FDA agreement for Phase 3
combination study in R/R cutaneous T-cell lymphoma . Initiate Phase 3 global
registration combination study in patients with R/R CTCL FOLO FOLOT
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Potential for
Significant Milestone Payments and Royalties from Established Collaborations
FERAHEME FOLOTYN 11 . Takeda: Strategic alliance for developments and
commercialization of FERAHEME . $60 million upfront payment received in 2010
. Up to $220 million in potential development and milestones $33 .
Mundipharma: Strategic collaboration for the codevelopment and
commercialization of FOLOTYN outside the U.S. and Canada . $50 million
upfront payment received in May 2011 U $310 5 illi i i l l d commercial
milestones, which includes up to million of potential milestones related to
EU and Canadian approvals and launches in IDA in CKD . Double-digit, tiered
royalties based on net sales in licensed territories . Up to 310.5 million in
potential regulatory and commercial progress- and sales-dependent milestone
payments . Double-digit, tiered royalties based on net sales in licensed
territories . FERAHEME commercial rights . AMAG retains full commercial
rights in the U.S. . Takeda has rights in select ex-U.S. territories,
including Europe; . Joint funding of R&D costs, initially 60% Allos and
40% Mundipharma, changes to 50:50 if certain predefined milestones are
achieved, including approval of EU MAA currently under review . FOLOTYN
commercial rights . 3SBio: responsible for development and commercialization
in China . Allos retains full commercial rights in the U.S. and Canada .
Mundipharma has rights in the rest of world C bi d h t ti l t t $530 5 illi i
d l t d i l il t Combined company has potential to earn up to 530.5 million
in development and commercial milestones
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Combined
Company Expected to Realize Annual Synergies of $55 to $60 Million Expected
Annual Primary Driver 12 Synergies Selling, General and Administrative $38 mm
- $41 mm .Rationalization of redundant public company expenses (includes
facilities rationalization) . Rationalization of redundant personnel,
including field force optimization .Consolidation of headquarters to
Lexington, MA Research & Development $17 mm - $19 mm .Rationalization of
redundant personnel Total $55 mm - $60 mm* Majority of synergies expected
to be realized in 2012 *excludes stock-based compensation expense synergies
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2010 Net
Product Revenues 2010 Net Product Revenue ($MM) 2010 Net Product Revenue
Contribution % 13 FOLOTYN 90 100 60 70 80 30 40 50 FERAHEME 0 10 20 FERAHEME
FOLOTYN Combined
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Financial and
Strategic Benefits of Merger . Combined company will have a diversified
portfolio of commercial d f d hi h i l k i h l i 14 products focused on
high-potential markets with overlapping customer segments . FERAHEME®
(ferumoxytol injection) for the treatment of iron deficiency anemia (IDA)
in adult patients with chronic kidney disease (CKD) . FOLOTYN® (pralatrexate
injection) for the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL) . Global development programs expected to
drive expanded market opportunities for both brands . Combined company
expected to realize annual synergies of $55 million to $60 million from cost
reductions . Majority to be realized in the first fiscal year after close .
Strong balance sheet for business reinvestment and further portfolio
diversification
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I N V E S T O R
P R E S E N T A T I O N AMAG Pharmaceuticals and Allos Therapeutics to Merge
p g July 20, 2011 Creates Company With Strengthened Commercial Portfolio
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