AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG) Files An 8-K Entry into a Material Definitive Agreement

AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG) Files An 8-K Entry into a Material Definitive Agreement

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Item 1.01 Entry into a Material Definitive Agreement

On February 13, 2017, AMAG Pharmaceuticals, Inc. (AMAG) and
Endoceutics, Inc. (Endoceutics) entered into a license agreement
(the License Agreement) to which Endoceutics has agreed to grant
to AMAG rights to IntrarosaTM>(prasterone), an
FDA-approved product for the treatment of moderate-to-severe
dyspareunia (pain during sexual intercourse). The License
Agreement grants AMAG the right to develop and commercialize
pharmaceutical products containing dehydroepiandrosterone (DHEA),
including Intrarosa, at dosage strengths of 13 mg or less per
dose and formulated for intravaginal delivery (the Product),
excluding any dosage strengths over 13 mg per dose and
combinations with other active pharmaceutical ingredients, in the
United States for the treatment and prevention of vulvar and
vaginal atrophy (VVA) and female sexual dysfunction (FSD) (the
Field). The closing of the transactions contemplated by the
License Agreement (the Effective Date) is subject to clearance
under the Hart-Scott-Rodino Act and other customary closing
conditions.
Subject to the terms of the License Agreement, Endoceutics has
agreed to conduct clinical studies for use of the Product in FSD
to support an application for regulatory approval for the Product
for use in FSD in the United States. AMAG and Endoceutics have
agreed to share the direct costs related to such studies based
upon a negotiated allocation with AMAG funding up to $20.0
million. AMAG may, with Endoceutics consent (not to be
unreasonably withheld, conditioned or delayed), conduct any other
studies of the Product in the Field anywhere in the world for the
purpose of obtaining or maintaining regulatory approval of or
commercializing the Product in the Field in the United States.
All data generated in connection with the above described studies
would be owned by Endoceutics and licensed to AMAG to the License
Agreement.
AMAG will be granted the exclusive right to commercialize the
Product in the Field in the United States, subject to the terms
of the License Agreement, including having final decision making
authority with respect to commercial strategy, pricing and
reimbursement and other commercialization matters. AMAG has
agreed to use commercially reasonable efforts to market, promote
and otherwise commercialize the Product in the Field in the
United States. Endoceutics has the right to directly conduct,
itself or through its affiliates or subcontractors, additional
commercialization activities for the Product in the Field in the
United States, which scope of activities will be agreed to by the
parties acting reasonably and in good faith, and has the right to
conduct activities related generally to the field of
intracinology, in each case, subject to AMAGs right to withhold
approval in certain instances.
to the terms of the License Agreement, promptly following the
Effective Date, AMAG has agreed to make an upfront cash payment
of $50.0 million, and (subject to certain conditions) has agreed
to issue 600,000 shares of unregistered common stock, to
Endoceutics, 300,000 of which will be subject to a 180-day
lock-up provision, and the other 300,000 of which will be subject
to a one-year lock-up provision. AMAG has also agreed to make a
payment of $10.0 million to Endoceutics on the first anniversary
of the Effective Date and up to $10.0 million upon the delivery
of launch quantities of the Product. AMAG has also agreed to pay
tiered royalties to Endoceutics equal to a percentage of net
sales of the Product in the United States ranging from mid-teens
(for calendar year net sales up to $150 million) to mid twenty
percent (for any calendar year net sales that exceed $1 billion)
(such royalty rate to be dependent on the aggregate net sales of
the Products) for the commercial life of the Product, with
deductions after the later of (i) the expiration date of the last
to expire of a licensed patent containing a valid patent claim or
(ii) ten years after the first commercial sale of the Product in
the Field in the United States, generic competition and third
party payments. Endoceutics is also eligible to receive certain
sales milestone payments, including a first sales milestone
payment of $15.0 million, which would be triggered when Intrarosa
annual net U.S. sales exceed $150.0 million, and a second
milestone payment of $30.0 million, which would be triggered when
annual net U.S. sales exceed $300.0 million. If annual net U.S.
sales exceed $500.0 million, there are additional sales milestone
payments totaling up to $850 million, which would be triggered at
various sales thresholds.
In connection with the License Agreement, AMAG and Endoceutics
have agreed to enter into a commercial supply agreement on or
about the Effective Date, to which Endoceutics, itself or through
affiliates or contract manufacturers, would agree to manufacture
and supply the Product to AMAG (the Supply Agreement) and would
be AMAGs exclusive supplier of the Product in the United States,
subject to certain rights for AMAG to manufacture and supply the
Product in the event of a cessation notice or supply failure (as
such terms are defined in the Supply Agreement). Under the Supply
Agreement, Endoceutics would maintain at all times a second
source supplier for the manufacture of DHEA and the drug product
and identify and validate and transfer manufacturing intellectual
property to the second source supplier within two years of the
Effective Date. The Supply Agreement remains in effect until the
termination of the License Agreement, unless terminated earlier
by either party for an uncured material breach or insolvency of
the other party, or by AMAG if it exercises its rights to
manufacture and supply the Product following a cessa
tion notice or supply failure.
Under the License Agreement, except as permitted under the
License Agreement or the Supply Agreement, and except for any
compounds or products affecting the melanocortin receptor
pathway, including without limitation, bremelanotide
(collectively, Excluded Product), AMAG will not be permitted to
research, develop, manufacture, or commercialize (i) DHEA for
delivery by any route of administration anywhere in world, (ii)
any compound (including DHEA) or product for use in VVA
anywhere in the world, or (iii) commencing on the date of an
approval of the Product for the treatment of FSD in the United
States and continuing for the remainder of the term of the
License Agreement, any compound (including DHEA) for use in FSD
(each, a Competing Product). Any compound or product for use in
FSD that would be a Competing Product in the United States but
that (i) does not contain DHEA and (ii) was acquired or
licensed or for which the research, development, manufacture or
commercialization of such compound or product is initiated by
AMAG or its affiliates, in each case, prior to the date of an
approval of the Product for the treatment of FSD in the United
States, will be an Excluded Product and will not be subject to
the exclusivity obligations under the License Agreement in the
treatment of FSD, subject to certain restrictions in the
License Agreement. These noncompete restrictions are subject to
certain exclusions relating to the acquisition of competing
programs.
AMAG and Endoceutics have made customary representations and
warranties and have agreed to certain customary covenants. The
License Agreement expires on the date of expiration of all
royalty obligations due thereunder unless earlier terminated in
accordance with the License Agreement. The License Agreement
may be terminated by either Party if the Effective Date has not
occurred within 180 days following the execution date or such
date as the parties may mutually agree. The License Agreement
may be terminated by either Party for material breach that is
either uncured after a 90-day notice period, or if such breach
cannot be cured within such 90-day period, if the breaching
party does not commence appropriate and material actions to
cure such breach within the notice period and continue to
diligently cure such breach for a period not to exceed 90 days,
in either case, subject to tolling or determination of the
arbitrators, if dispute resolution procedures are initiated
within 30 days of the termination notice. AMAG has the ability
to elect not to terminate the License Agreement in the case of
a material breach, in which case future milestone and royalty
payments owed to Endoceutics would be reduced by a negotiated
percentage or by an amount determined by arbitration. Either
party may terminate under certain situations relating to the
bankruptcy or insolvency of the other party. AMAG may terminate
the License Agreement for a valid business reason upon 365 days
prior written notice to Endoceutics; or upon 60 days written
notice in the event AMAG reasonably determines in good faith,
after due inquiry and after discussions with Endoceutics, that
AMAG cannot reasonably continue to develop or commercialize any
Product as a result of a safety issue regarding the use of the
Product. AMAG may also terminate the License Agreement upon 180
days notice if there is a change of control of AMAG and the
acquiring entity (alone or with its affiliates) is engaged in a
competing program (as defined in the Licensed Agreement) in the
United States or in at least three countries within the
European Union.
Endoceutics has represented that the historical research and
development costs incurred to date by Endoceutics and its
affiliates (including any third party costs and expenses) in
connection with the Product are approximately CAD $19.6 million
(approximately USD $15.0 million) since January 1, 2014,
including (i) CAD $10,127,220 (approximately USD $7.7 million)
during the twelve months ended December 31, 2014, (ii) CAD
$4,896,520 (approximately USD $3.8 million) during the twelve
months ended December 31, 2015, and (iii) CAD $4,559,816
(approximately USD $3.5 million) during the twelve months ended
December 31, 2016. AMAG is not assuming any liabilities
(including contingent liabilities), acquiring any physical
assets, or hiring or acquiring any employees from Endoceutics
in connection with the License Agreement.
The foregoing summary is qualified in its entirety by reference
to the License Agreement and Supply Agreement, each of which
AMAG expects to file as an exhibit to its Quarterly Report on
Form 10-Q for the quarter in which such agreement is entered,
if not earlier on a Current Report on Form 8-K. AMAG intends to
seek confidential treatment for certain portions of the License
Agreement and the Supply Agreement.
Item 2.02. Results of Operations and Financial Condition.
The following information and Exhibit 99.1 and Exhibit 99.2
attached hereto shall not be deemed filed for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended
(the Exchange Act), or otherwise subject to the liabilities of
that section, nor shall they be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended (the Securities Act), except as expressly set forth by
specific reference in such filing.
On February 14, 2017 AMAG issued a press release entitled AMAG
Reports Fourth Quarter and Full Year 2016 Financial Results
regarding its operating results for the quarter and year ended
December 31, 2016 and its intention to
hold a conference call to discuss AMAGs financial results and
provide a business update. A copy of AMAGs press release is
furnished herewith as Exhibit 99.1 and a copy of the
presentation slides to be used during the conference call is
furnished herewith as Exhibit 99.2.
Item 3.02 Unregistered Sales of Equity Securities.
to the License Agreement described in Item 1.01 of this
Current Report on Form 8-K, which description is incorporated
herein by reference, and subject to the occurrence of the
Effective Date and certain other conditions, including there
being a valid exception from registration under the
Securities Act, AMAG expects to issue 600,000 shares of
unregistered AMAG common stock to Endoceutics within five
days of the Effective Date. The issuance of these shares to
Endoceutics will not be registered under the Securities Act
in reliance upon an exception from registration to Regulation
S promulgated under the Securities Act.
Item 7.01. Regulation FD Disclosure
The following information and Exhibit 99.3 attached hereto
shall not be deemed filed for purposes of Section 18 of the
Exchange Act, or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in
any filing under the Securities Act, except as expressly set
forth by specific reference in such filing.
On February 14, 2017, AMAG issued a press release, entitled
AMAG And Endoceutics Enter Into An Exclusive U.S. License
Agreement For IntrarosaTM>(Prasterone)
announcing that it had executed the License Agreement and its
intention to hold a conference call to present further
details regarding the License Agreement. A copy of such press
release is furnished as Exhibit 99.3 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
AMAG hereby furnishes the following exhibits:
Exhibit
Number
Description
99.1
Press release entitled AMAG Reports Fourth Quarter
and Full Year 2016 Financial Results issued by AMAG
Pharmaceuticals, Inc. on February 14, 2017.
99.2
Copy of AMAG Pharmaceuticals, Inc.s presentation
slides dated February 14, 2017.
99.3
Press release entitled AMAG And Endoceutics Enter
Into An Exclusive U.S. License Agreement For
IntrarosaTM (Prasterone) issued by AMAG
Pharmaceuticals, Inc. on February 14, 2017.
Forward Looking Statements
This Current Report on Form 8-K and the materials furnished
herewith contains forward-looking information about AMAG
within the meaning of the Private Securities Litigation
Reform Act of 1995 and other federal securities laws. Any
statements contained herein and therein which do not describe
historical facts, including, among others, statements
regarding each partys respective performance of its
obligations under the License Agreement and the Supply
Agreement, including with respect to funding additional
clinical trials and conducting commercialization activities;
anticipated clinical development plans and costs for
Intrarosa to support regulatory approval of FSD; expected
timing for the closing of the transaction under the License
Agreement; the timing and amounts of future milestone and
royalty payments; and expected investment amounts by AMAG in
the potential FSD label expansion and those statements in the
materials furnished herewith that are designated as
forward-looking statements 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, among others, (1) the
possibility that the closing conditions set forth in the
License Agreement, including, those related to antitrust
clearance, will not be met and that the parties will be
unable to consummate the proposed transactions; (2) the
possibility that AMAG will not realize the expected benefits
of the transaction, including the anticipated market
opportunity and the ability of its current or expanded sales
force to successfully commercialize Intrarosa; (3) the
possibility that significant safety or drug interaction
problems could arise with respect to Intrarosa; (4) the
ability of AMAG to drive awareness of dyspareunia and the
potential benefits of Intrarosa; (5) uncertainties regarding
the manufacture of Intrarosa; (6) uncertainties relating to
patents and proprietary
rights associated with Intrarosa in the United States; (7)
that the cost of the transaction to AMAG will be more than
planned and/or will not provide the intended positive
financial results; (8) that AMAG or Endoceutics will fail
to fully perform their respective obligations under the
License Agreement or the Supply Agreement; (9) uncertainty
regarding AMAGs ability to compete in the dyspareunia
market in the United States; and (10) other risks
identified in AMAGs Securities and Exchange Commission
(SEC) filings, including its Annual Report on Form 10-K for
the year ended December 31, 2015, its Quarterly Reports on
Form 10-Q for the quarters ended March 31, 2016, June 30,
2016 and September 30, 2016 and subsequent filings with the
SEC, including its Current Report on Form 8-K filed with
the SEC on January 9, 2017 and February 3, 2017, as well as
in its upcoming Annual Report on Form 10-K for the year
ended December 31, 2016. AMAG cautions you not to place
undue reliance on any forward-looking statements, which
speak only as of the date they are made. AMAG disclaims 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.
AMAG Pharmaceuticals is a registered trademark of AMAG
Pharmaceuticals, Inc. IntrarosaTM>is a
registered trademark of Endoceutics.


About AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG)

AMAG Pharmaceuticals, Inc. is a pharmaceutical company. The Company’s segment is the manufacture, development and commercialization of products and services for use in treating various conditions, with a focus on maternal health, anemia management and cancer supportive care. Its offerings focus on maternal health, anemia management and cancer supportive care, including its product, Makena (hydroxyprogesterone caproate injection); services related to the collection, processing and storage of umbilical cord blood stem cell and cord tissue units operated through Cord Blood Registry (CBR); its product, Feraheme (ferumoxytol), for intravenous (IV) use, and MuGard Mucoadhesive Oral Wound Rinse. It is engaged in the development of Digoxin immune fab, a polyclonal antibody for the treatment of severe preeclampsia in pregnant women. Makena is a drug indicated to reduce the risk of preterm birth in women pregnant with a single baby having a history of singleton spontaneous preterm birth.

AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG) Recent Trading Information

AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG) closed its last trading session down -0.05 at 22.65 with 1,700,322 shares trading hands.

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