AMAG Pharmaceuticals,Inc. (NASDAQ:AMAG) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement
On January8, 2017, AMAG Pharmaceuticals,Inc. (the Company)
entered into a license agreement (the License Agreement)
with Palatin Technologies,Inc. (Palatin). Under the terms
of the License Agreement, subject to the conditions set forth
therein, Palatin will grant to the Company (i)an exclusive
license in all countries of North America (the Territory), with the right to
grant sub-licenses, to research, develop and commercialize
products containing bremelanotide (each a Product, and collectively,
Products), an investigational product designed to be an
on-demand treatment for hypoactive sexual desire disorder
(HSDD) in pre-menopausal women, (ii)a non-exclusive
license in the Territory, with the right to grant sub-licenses,
to manufacture Products, and (iii)a non-exclusive license in all
countries outside the Territory, with the right to grant
sub-licenses, to research, develop and manufacture (but not
commercialize) the Products.
to the terms of the License Agreement, and subject to the
conditions set forth therein, the Company is required to make the
following payments to Palatin: (i)$60 million as a one-time
initial research payment within five days following the date of
the closing of the transactions contemplated by the License
Agreement (the Effective
Date), and (ii)up to an aggregate amount of $25 million to
reimburse Palatin for all reasonable, documented, out-of-pocket
expenses incurred by Palatin, following the Effective Date, in
connection with the development and regulatory activities
necessary to file a new drug application (NDA) for a
Product for HSDD in the United States.
In addition, to the terms of the License Agreement, Palatin will
be eligible to receive from the Company: (i)up to $80 million in
specified regulatory payments upon achievement of certain
regulatory milestones, and (ii)up to $300 million in sales
milestone payments based on achievement of annual net sales
amounts for all Products in the Territory.
The Company is also obligated to pay Palatin tiered royalties on
annual net sales of Products, on a product-by-product basis, in
the Territory ranging from the high-single digits to the low
double-digits. The royalties will expire on a product-by-product
and country-by-country basis until the latest to occur of (i)the
earliest date on which there are no valid claims of Palatin
patent rights covering such Product in such country, (ii)the
expiration of the regulatory exclusivity period for such Product
in such country and (iii)ten years following the first commercial
sale of such Product in such country. Such royalties are subject
to reduction in the event that: (a)the Company must license
additional third party intellectual property in order to develop,
manufacture or commercialize a Product or (b)generic competition
occurs with respect to a Product in a given country, subject to
an aggregate cap on such deductions of royalties otherwise
payable to Palatin. After the expiration of the applicable
royalties for any Product in a given country, the license for
such Product in such country would become a fully paid-up,
royalty-free, perpetual and irrevocable license.
Closing is subject to customary conditions, as well as, if
required, Palatins delivery of financial statements to be filed
by the Company with the Securities and Exchange Commission
(SEC) to Rule3-05 of Regulation S-X.
The Company and Palatin have made customary representations and
warranties and have agreed to certain customary covenants,
including confidentiality and indemnification.
The License Agreement expires on the date of expiration of all
royalty obligations due thereunder unless earlier terminated in
accordance with the agreement. If any of the closing conditions
have not been met within 120 days of the date of signing of the
License Agreement, the Company has the right to terminate the
License Agreement upon ten days written notice to Palatin. In
addition, the Company has the right to terminate the License
Agreement without cause, in its entirety or on a
product-by-product and country-by-country basis upon at least 180
days prior written notice to Palatin. Either party may terminate
the License Agreement for cause if the other party materially
breaches or defaults in the performance of its obligations, and,
if curable, such material breach remains uncured for 90 days.
The foregoing is only a summary of the material terms of the
License Agreement and does not purport to be a complete
description of the rights and obligations of the parties under
such agreement. The foregoing summary is qualified in its
entirety by reference to the available text of the License
Agreement, a redacted copy of which the Company expects to file
as an exhibit to its Annual Report on Form10-K for the fiscal
year ended December31, 2016.
Item 2.02. Results of Operations and Financial
Condition.
The following information and Exhibit99.1 attached hereto shall
not be deemed filed for purposes of Section18 of the Securities
and Exchange Act of 1934, as amended (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 of 1933, as amended (the Securities
Act), except as expressly set forth by specific reference in
such filing.
On January9, 2017, the Company issued a press release entitled
AMAG Pharmaceuticals Provides Financial and Business Update,
providing a business update, including preliminary unaudited
fourth quarter and annual 2016 financial results, 2017
financial guidance, and an update on its Makena subcutaneous
auto-injector (SC) program. A copy of the Companys press
release is furnished herewith as Exhibit99.1.
Item 7.01. Regulation FD.
The following information and Exhibit99.2 attached hereto shall
not be deemed filed for purposes of Section18 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.
The Company will present further details on the matters noted
above, including the Companys License Agreement with Palatin at
the 35th Annual J.P. Morgan Healthcare Conference in San
Francisco on January10, 2017, which will be accessible by a
live audio webcast through the Companys website at
www.amagpharma.com on January10, 2017 at 11:30 a.m.Pacific Time
(2:30 p.m.Eastern Time). A copy of the Companys presentation
slides are furnished herewith as Exhibit99.2.
Item 8.01 Other Events
On January9, 2017, the Company issued a press release, entitled
AMAG Pharmaceuticals and Palatin Technologies Enter Into
Exclusive Licensing Agreement for North American Rights to
Rekynda (Bremelanotide), a Potential Treatment for a Common
Female Sexual Disorder, announcing that it had entered into the
License Agreement. A copy of such press release is filed as
Exhibit99.3 hereto.
This report contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
(PSLRA) and other federal securities laws. Any
statements contained herein which do not describe historical
facts, including, among others, expectations for the Companys
growth strategy; the Companys anticipated expansion in womens
health through the licensing transaction with Palatin and plans
regarding the development activity of Rekynda; the structure of
planned and pending clinical trials for Rekynda; the expected
timeline, indications and expenditures for clinical development
and commercialization of Rekynda, including the timing for the
NDA, subsequent FDA action and commercial launch; Rekyndas
strategic fit for the Companys womens health business; the
competitive landscape and breadth of the female sexual
dysfunction (FSD) and HSDD markets and Rekyndas
potential benefits and market potential; expectations for
future next-generation formulations of Rekynda; the Companys
and Palatins anticipated intellectual property rights
associated with Rekynda; the expected timing for the closing of
the Rekynda transaction; the timing and value of payments by
the Company under the Rekynda licensing transaction; the impact
of the Rekynda product on the Companys financial results;
expectations regarding the safety, efficacy and benefits of
Rekynda, including that no boxed warning or restrictive REMS
programs are anticipated; the potential value Rekynda will
create for the Companys shareholders; Makenas position in the
market and future growth drivers for Makena, including the
potential market opportunity, progress for the next-generation
development programs and customer engagement and outreach;
beliefs that the current SC formulation for Makena offers
potential for more convenient and alternative administration;
plans to explore alternative injection sites and formulations
for Makena; expected timing for the Companys supplemental new
drug application (sNDA) for Makena (including expected
timing for an FDA decision on the sNDA) and collection and
analysis of data, and results, from the definitive
pharmacokinetic study; the Companys belief that it will not
request orphan drug exclusivity; the Companys intentions to
request Orange Book listing of Antares eligible drug-device
patents; growth drivers for Cord Blood Registry (CBR),
including plans to differentiate CBR offerings and increase
engagement and communications in the industry; expectations for
Feraheme, including growth for the intravenous (IV) iron
market and the position of Feraheme within the IV iron market;
anticipated growth drivers for Feraheme, including plans to
optimize net revenue per gram and grow in key segments;
expected timing for reporting clinical trial results and
submitting the sNDA for the expanded Feraheme label and
expectations that the size of the addressable market, if the
broader indication is approved, would double; preliminary and
unaudited financial results and cash and debt position for 2016
and the Companys 2017 financial guidance, including forecasted
GAAP and non-GAAP revenues, GAAP and non-GAAP net income, GAAP
operating income and adjusted EBITDA; expectations for the
Companys key priorities in 2017, including plans to drive net
product sales growth, increase non-GAAP adjusted EBITDA and
undertake portfolio expansion activities, including by
licensing and acquisition of products or companies; the
Companys beliefs that its commercial team will serve it well
for the long-term and that its record revenues in 2016 position
it well for future growth in 2017; the Companys 2017 financial
outlook, including revenue, operating income, adjusted EBITDA
and net income; expectations regarding top-line and adjusted
EBITDA growth in 2017; plans to continue to diversify the
Company portfolio and achieve a mix of commercial assets and
development pipeline for long-term growth; plans to continue to
enhance and scale the Companys internal capabilities; and
beliefs that newborn stem cells have
the potential to play a valuable role in the development of
regenerative medicine 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, if required, Palatins delivery of
any financial statements to be filed by the Company under
Rule3-05 of Regulation S-X, will not be met and that the
parties will be unable to consummate the proposed transactions,
(2)uncertainties regarding the Companys and Palatins ability to
successfully and timely complete clinical development programs
and obtain regulatory approval for Rekynda in North America,
(3)the possibility that significant safety or drug interaction
problems could arise with respect to Rekynda, (4)the ability of
the Company to raise awareness and understanding of HSDD and
the potential benefits of Rekynda, (5)uncertainties regarding
the manufacture of Rekynda, (6)uncertainties relating to our
and Palatins patents and proprietary rights associated with
Rekynda in North America, (7)that the cost of the Rekynda
transaction to the Company will be more than planned and/or
will not provide the intended positive financial results,
(8)that the Company or Palatin will fail to fully perform under
the License Agreement, (9)uncertainty regarding the Companys
ability to compete in the FSD market in North America, and
(10)as well as those risks identified in the Companys filings
with the SEC, including its Annual Report on Form10-K for the
year ended December31, 2015, its Quarterly Reports on Form10-Q
for the quarters ended March31, 2016, June30, 2016 and
September30, 2016 and subsequent filings with the SEC. Any such
risks and uncertainties could materially and adversely affect
the Companys results of operations, its profitability and its
cash flows, which would, in turn, have a significant and
adverse impact on the Companys stock price. The Company
cautions you not to place undue reliance on any forward-looking
statements, which speak only as of the date they are made. The
Company 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 and Feraheme are registered trademarks of
the Company. MuGard is a registered trademark of Abeona
Therapeutics,Inc. Makena is a registered trademark of AMAG
Pharmaceuticals IP,Ltd. Cord Blood Registry and CBR are
registered trademarks of CBR Systems,Inc. RekyndaTMis a
trademark of Palatin.
Item 9.01 Financial Statements and Exhibits
(d)Exhibits
|
ExhibitNo. |
|
Description |
|
99.1* |
Press Release, entitled AMAG Pharmaceuticals Provides |
|
|
99.2* |
Copy of Companys presentation slides dated January2017 |
|
|
99.3** |
Press Release, entitled AMAG Pharmaceuticals and Palatin |
* Furnished herewith
** Filed herewith
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 -12.70 at 23.00 with 742,652 shares trading hands.
