- Filing of certain prospectuses and communications in connection with business combination transactions (425)
30 Setembro 2011 - 6:01PM
Edgar (US Regulatory)
Filed by AMAG Pharmaceuticals, Inc.
Pursuant to Rule 425 under the Securities Act of 1933, as amended
and deemed filed pursuant to Rule 14a-12
of the Securities Exchange Act of 1934, as amended
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, as amended, by and among Allos, AMAG and Merger Sub.
Below is are materials from an AMAG meeting with ISS on September 30, 2011.
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AMAG
Pharmaceuticals, Inc. FALL 2011 1
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Forward-looking
Statements 2 This presentation contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 and other
federal securities laws. Any statements contained herein which do not
describe historical facts, including but not limited to, our statements
regarding the expected timing of regulatory decisions on our Feraheme
marketing applications in the EU, Canada and Switzerland, our expectations
regarding the timing of completion of enrollment in our Feraheme phase III
global registrational program for a broad IDA indication, our estimates of
the potential size and growth of the non-dialysis CKD and broad IDA markets
and opportunities, our belief that the addition of FOLOTYN® to our product
portfolio will enable us to gain valuable synergies and create additional
shareholder value, our expectations on the expected size and timing of
realization of synergies, our beliefs in the strategic, commercial and financial
rationale for the merger, the expected timing of closing of the proposed
merger, our expectations regarding the future cash flow impact of the merger
on the combined company, our expectations regarding the combined net product
revenues and expenses of the combined company, our expectation to achieve
cash flow neutrality by year-end 2013, our expectation regarding the combined
companys cash position and potential milestone payments we may receive from
Takeda and/or Mundipharma, the potential financial upside opportunities
associated with Feraheme and Folotyn, and our statements regarding the 2011
and 2012 milestones for Feraheme and Folotyn are forward-looking statements
which involve risks and uncertainties that could cause actual results to
differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include: the failure of Allos or AMAG
stockholders to approve the proposed transaction; the challenges and costs of
closing the proposed transaction, integrating the two companies, and
restructuring the combined company; the possibility that the expected
synergies and additional cost savings will not be realized, or will not be
realized within the expected time period; our ability to retain key
employees; competitive risks associated with both Feraheme and Folotyn;
uncertainties regarding our ability to successfully and timely complete our
clinical development programs and obtain regulatory approval for Feraheme in
new indications and in territories outside of the U.S.; uncertainties
relating to patents and proprietary rights; 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 Risk Factors
section of Allos Quarterly Report on Form 10-Q for the quarter ended June
30, 2011, the Risk Factors section of AMAGs Quarterly Report on Form 10-Q
for the quarter ended June 30, 2011, and in Allos and AMAGs other periodic
reports and filings with the SEC. We caution you not to place undue reliance
on any forward-looking statements, which speak only as of the date they are
made. We disclaim any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events, conditions or
circumstances on which any such statements may be based, or that may affect
the likelihood that actual results will differ from those set forth in the
forward-looking statements.
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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 AMAG and Allos for their consideration. AMAG has filed 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).
The Registration Statement on Form S-4 has been declared effective by the
SEC. Investors are urged to read the joint proxy statement/prospectus and
other relevant documents filed with the SEC because they contain important
information. Security holders may obtain a free copy of the proxy
statement/prospectus 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 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 investors or
AMAGs investors generally, are set forth in the joint proxy
statement/prospectus filed with the SEC. 3
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Deal Background
AMAG Board of Directors met in December 2010 and discussed the companys
business and strategy Determined that the company should pursue two parallel
paths to enhance long-term stockholder value the sale of the company and/or
a transformative strategic acquisition Engaged Morgan Stanley as a financial
advisor Established a transaction committee To review the Allos and related
transactions: AMAGs Board of Directors met 6 times Independent transaction
committee met 9 times AMAG pursued discussions with numerous companies, deal
scenarios included both the company being acquired and being acquisitive No
offers were received for AMAG during this time and the Board determined that
the best path forward was a transformative acquisition to leverage the
infrastructure at AMAG 4
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Merger
Highlights 5 Terms Stock for stock transaction Allos stockholders will
receive 0.1282 AMAG shares for each Allos share held Ownership at Closing
AMAG 61% / Allos 39% 2010 Product Revenues Feraheme 2010 net product
revenues: $59.3 million Folotyn 2010 net product revenues: $35.2 million Cash
Position 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 Board of Directors Total of 9 Directors 5 from AMAG [Brian J.G.
Pereira, M.D., Michael Narachi (Chairman), Dr. Lesley Russell, Davey S. Scoon
and Ron Zwanziger] 4 from Allos (Paul L. Berns, Stephen J. Hoffman, David M.
Stout and one additional member to be determined) CEO, Headquarters and Name
Brian J.G. Pereira, MD, Chief Executive Officer Headquarters: Lexington, MA Combined
company expected to be renamed to reflect strategic focus Closing Conditions
Subject to customary closing conditions Stockholder approval for both Allos
and AMAG Transaction Close Stockholder votes on October 21, 2011 Expected
closing in fourth quarter 2011
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NewCo:
Improving Patients Lives and Enhancing Value for Stockholders 6
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NewCo Two
Commercial Products Provide Solid Foundation for Growth 7
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FERAHEME
FOLOTYN Description Therapeutic iron formulation delivered via intravenous (IV)
injection Folate analogue metabolic inhibitor delivered via intravenous (IV)
injection Labeled Indication Approved in June 2009 for the treatment of iron
deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD)
Approved in September 2009 for the treatment of relapsed or refractory
peripheral T-cell lymphoma (R/R PTCL) Label Expansion Opportunities Ongoing
registrational program for the treatment of IDA regardless of the underlying
cause Two post-approval global Phase 3 registration studies; newly diagnosed
PTCL patients (enrolling) and relapsed or refractory cutaneous T-cell
lymphoma (CTCL) planned Commercial Rights Retains U.S. commercialization
rights Ex-U.S. rights licensed to Takeda and 3SBio (China) Retains U.S. /
Canada commercialization rights ROW rights licensed to Mundipharma
International Geographic Expansion Canadian and EU regulatory decisions for
IDA in CKD expected in 2011 and 2012, respectively EU regulatory decision for
R/R PTCL expected in early 2012 Patent Life 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 Competition One of five IV irons on the market; recent
class labeling levels the planning field among competitive products One of
three agents for PTCL, first to market Value Proposition Demonstrated
clinical efficacy Favorable dosing schedule Full one gram dose of iron
delivered in 2 visits Each 510 mg administration is injected in under 1
minute Broad indication in R/R PTCL subtypes Demonstrated durable clinical
responses Rapid onset of action 3 to 5 minute IV push Two Commercial Products
with Compelling Value Propositions 8
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Feraheme and
Folotyn: Attractive Opportunities for Continued Growth 9 Market detail
Non-dialysis CKD Incidence 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 typically administered at hematology / oncology infusion center,
hospital outpatient infusion center or nephrology clinics; Patients receive
approximately 1.5 grams of IV iron per year AMAG estimates that approximately
50% of non-dialysis IV iron used in the US is for the treatment of CKD
patients Sources: 1 US Census 2 U.S. Renal Data System, USRDS 2010 Annual
Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in
the United States, National Institutes of Health, National Institute of
Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42. 3 Fishbane,
S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol.
2009 January; 4(1): 5761. 4 Company Estimates FERAHEME Market detail Peripheral
T-Cell Lymphoma High Unmet Need 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 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 FOLOTYN 33 million U.S. adults with CKD1,2 >1.6
million have diagnosed CKD and iron deficiency anemia3,4 Between 200,000 and
250,000 are treated with IV Iron4 5,900 newly diagnosed patients 4,900 2nd
line 5,100 3rd line plus 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. 9 16
million adults with stage 3 - 5 CKD2
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Multiple
Milestones Provide Future Growth Opportunities 2011 Milestones Feraheme
Second source manufacturing approved Decision expected regarding Canadian
regulatory application for IDA in CKD Folotyn Initiate Phase 3 study in newly
diagnosed PTCL patients; SPA agreement with FDA in place first patient
enrolled 08/11 Seek FDA agreement for Phase 3 combination study in R/R
cutaneous T-cell lymphoma 2012 Milestones Feraheme Complete enrollment of
broad IDA Phase 3 registration program EU CKD approval and launch Canadian
CKD launch Swiss CKD decision and launch IDA program data; sNDA submission
for broad IDA indication Folotyn Decision expected in EU for R/R PTCL
Potential EU R/R PTCL launch Initiate Phase 3 global registration combination
study in patients with R/R CTCL 10
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Strategic
Rationale of Merger First step in building a profitable specialty
pharmaceutical company focused on hematology and oncology Overlapping call
points in hematology/oncology and hospitals provide enhanced access for
Feraheme Largest non-dialysis CKD market segments for IV iron today Folotyn
strengthens hematology/oncology relationships, which could be leveraged if
broad IDA indication is approved Commercial footprint that exists today will
support both Feraheme and Folotyn Increases account access & penetration
70 75 representative provide 100% coverage of target accounts for both
brands Increases share of voice for both brands NewCo expected to realize
annual synergies of $55 - $60 million 11
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NewCo Financial
Rationale Conservative combined net product revenues in 2013 of at least $125
million Assuming current US labels/indications for Folotyn and Feraheme, and
EU and Canadian approval for Feraheme for CKD NewCo cash operating expenses
in 2013 expected to be no greater than $120 million (excluding COGS)
Companies had estimated $215 - $230 million in combined cash operating
expenses for full year 2011 (excluding COGS and merger related expenses)
Folotyn provides approximately $20 million in incremental annual cash flow
generated by deal in 2013 Management is committed to driving NewCo to cash
flow breakeven by year-end 2013, earlier than either company alone NewCo cash
position not expected to fall below $220 million 12
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NewCo Expected
to Realize Annual Synergies of $55 to $60 Million Expected Annual Synergies
Primary Driver Selling, General and Administrative (includes facilities
rationalization) $38 mm - $41 mm Rationalization of redundant public company
expenses 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* 13 *excludes stock-based compensation expense synergies Majority
of cost synergies to be achieved in 2012 Additional $10 to $20 million of
annual cost savings to be achieved starting in 2013 through additional
commercial and clinical development cost reductions Clinical trial expenses
will be reduced by ~$30 million associated with IDA program completion in
2012
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Potential
Financial Upside Revenues Feraheme CKD and Folotyn revenue synergies through
expanded share of voice and access Feraheme sales from US IDA approval/launch
Folotyn sales from label expansions (first-line PTCL and rrCTCL) Folotyn use
derived from results of investigator sponsored research Royalties Feraheme
ex-US IDA royalties Earlier Folotyn EU royalties Milestones Up to $187
million additional milestones related to Feraheme clinical and commercial
success Up to $310.5 million related to Folotyn regulatory and commercial
progress and sales R&D Expenses 60/40 transitions to 50/50 cost sharing
with Mundipharma for Folotyn external clinical trial costs 14 Multiple
options and upside opportunities to financial valuation from new revenue
sources and cost sharing
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Focused on
Building Long-term Value for Shareholders We believe the merger with Allos
Therapeutics Expands access to hematology/oncology for Feraheme in CKD and
broad IDA indications Leverages existing commercial infrastructure and
cost-base in hematology/oncology space Spreads public company costs over
larger revenue base Provides further revenue opportunities and
diversification through new geographical markets and additional indications
NewCos center of gravity is hematology/oncology Feraheme and Folotyn share
this critical call point An area of high strategic interest NewCo
strategically positioned for future growth and value generation through
additional product acquisitions or licensing 15
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Thank You
INVESTOR CONTACT: 617-498-3361 16
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