ARALEZ PHARMACEUTICALS INC. (NASDAQ:ARLZ) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry Into A Material Definitive Agreement.
As previously reported, on February23, 2017, Aralez
Pharmaceuticals US Inc. (Aralez US), a Delaware company and a
wholly-owned, indirect subsidiary of Aralez Pharmaceuticals Inc.
(the Company), a company formed under the laws of the Province of
British Columbia, Canada, entered into a Novation Agreement (the
Novation Agreement) with AstraZeneca Pharmaceuticals LP
(AstraZeneca LP) and the United States of America (the
Government) to which all of the rights and responsibilities of
AstraZeneca LP under that certain VA National Contract signed
February11, 2016 and effective April29, 2016 between AstraZeneca
LP and the Government were novated to Aralez US (as novated, the
Agreement). The Novation Agreement was entered into to the Asset
Purchase Agreement, dated October3, 2016 (the Asset Purchase
Agreement), by and between the Company, Aralez Pharmaceuticals
Trading DAC, an Irish designated activity company and a
wholly-owned, indirect subsidiary of the Company and affiliate of
Aralez US, and AstraZeneca AB. Under the Agreement, Aralez US
provides products containing metoprolol succinate (sold under the
brand name Toprol-XL) as the active pharmaceutical ingredient at
fixed prices to the U.S. Department of Veterans Affairs and
certain other United States federal government agencies. The
Agreement has a one-year term expiring April 28, 2017, renewable
at the option of the Government for four successive additional
one-year terms.
On April6, 2017, Aralez US and the Government entered into a
Modification of Contract (the Contract Modification) to which the
Government exercised its first renewal option under the
Agreement, extending the term of the Agreement by one year to
April28, 2018 with modified pricing for the duration thereof. The
Contract Modification is filed as Exhibit10.1 to this report and
is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
The Company does not believe the Contract Modification will
impact its fiscal 2017 financial guidance issued on March13,
2017.
Forward-Looking Statements
This Current Report on Form8-K includes certain statements that
constitute forward-looking statements within the meaning of
applicable securities laws. Forward-looking statements include,
but are not limited to, statements regarding the Contract
Modification and that the Company does not believe the Contract
Modification will impact its fiscal 2017 financial guidance
issued on March13, 2017, and other statements that are not
historical facts, and such statements are typically identified by
use of terms such as may, will, would, should, could, expect,
plan, intend, anticipate, believe, estimate, predict, likely,
potential, continue or the negative or similar words, variations
of these words or other comparable words or phrases, although
some forward-looking statements are expressed differently.
You should be aware that the forward-looking statements included
herein represent managements current judgment and expectations,
and are based on current estimates and assumptions made by
management in light of its experience and perception of
historical trends, current conditions and expected future
developments, as well as other factors that it believes are
appropriate and reasonable under the circumstances, but there can
be no assurance that such estimates and assumptions will prove to
be correct and, as a result, the forward-looking statements based
on those estimates and assumptions could prove to be incorrect.
Accordingly, actual results, level of activity, performance or
achievements or future events or developments could differ
materially from those expressed or implied in the forward-looking
statements.
Our operations involve risks and uncertainties, many of which are
outside of our control, and any one or any combination of these
risks and uncertainties could also affect whether the
forward-looking statements ultimately prove to be correct and
could cause our actual results, level of activity, performance or
achievements or future events or developments to differ
materially from those expressed or implied by the forward-looking
statements. These risks and uncertainties include, without
limitation, our inability to maintain a sales force of sufficient
scale for the commercialization of our products in a timely and
cost-effective manner; our failure to successfully commercialize
our products and product candidates; competition, including
increased generic competition; costs and delays in the
development and/or approval of our product candidates (including
Yosprala in the EU), including as a result of the need to conduct
additional studies or due to issues with third-party API or
finished product
manufacturers, or the failure to obtain such approval of our
product candidates for all expected indications, including as a
result of changes in regulatory standards or the regulatory
environment during the development period of any of our product
candidates; with respect to certain products, dependence on
reimbursement from third-party payors and the possibility of a
failure to obtain coverage or reduction in the extent of
reimbursement; the inability to maintain or enter into, and the
risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and
distribution of any products, including our dependence on
AstraZeneca AB and Horizon Pharma USA,Inc. for the sales and
marketing of VIMOVO, our dependence on Patheon Pharmaceuticals
Inc. for the manufacture of Yosprala, our dependence on
Schering-Plough (Ireland) Company for the supply of Zontivity
and our dependence on AstraZeneca AB for the manufacture and
supply of Toprol-XL and its currently marketed authorized
generic (AG); our dependence on maintaining and renewing
contracts with customers, distributors and other counterparties
(certain of which are currently under negotiation), including
our inability to renew existing contracts on favorable terms,
and the risks that we may not be able to maintain our existing
terms with certain customers, distributors and other
counterparties; our ability to protect our intellectual
property and defend our patents; regulatory obligations and
oversight; failure to successfully identify, execute,
integrate, maintain and realize expected benefits from new
acquisitions, such as the acquisitions of Tribute
Pharmaceuticals Canada Inc., Zontivity and Toprol-XL and its
AG; fluctuations in the value of certain foreign currencies,
including the Canadian dollar, in relation to the U.S. dollar,
and other world currencies; changes in laws and regulations,
including tax laws and unanticipated tax liabilities and
regulations regarding the pricing of pharmaceutical products;
risks related to our financing; general adverse economic,
market and business conditions; and those risks detailed from
time-to-time under the caption Risk Factors and elsewhere in
the Companys filings and reports with the U.S. Securities and
Exchange Commission (SEC) and Canadian securities law filings,
including in our Annual Report on Form10-K for the year ended
December31, 2016, which is available on EDGAR at www.sec.gov,
on SEDAR at www.sedar.com, and on the Companys website at
www.aralez.com, and those described from time to time in our
future reports filed with the SEC and applicable securities
regulatory authorities in Canada. You should not place undue
importance on forward-looking statements and should not rely
upon this information as of any other date. We undertake no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future
events or otherwise, unless required by law.
Item9.01. Financial Statements and Exhibits
(d)List of Exhibits
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EXHIBIT NO. |
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DESCRIPTION |
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10.1 |
Modification of Contract, executed on April6, 2017, |
About ARALEZ PHARMACEUTICALS INC. (NASDAQ:ARLZ)
Aralez Pharmaceuticals Inc. is a Canada-based specialty pharmaceutical company. The Company focuses on acquiring, developing and commercializing products in cardiovascular, pain and other areas. The Company’s products include Fibricor, Cambia, Fiorinal, Fiorinal C, Soriatane, Bezalip SR, NeoVisc, Uracyst, Durela, Proferrin, Resultz and Collatamp G. Its development products include YOSPRALA and Bilastine. Fibricor (fenofibric acid) is indicated as a complementary therapy along with diet for the treatment of hypertriglyceridemia, and as a complementary therapy along with diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG) and apolipoprotein B (Apo B). Fibricor is also used to increase high-density lipoprotein (HDL) cholesterol (HDL-C) in patients with hypercholesterolemia or mixed dyslipidemia. Cambia (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug (NSAID). ARALEZ PHARMACEUTICALS INC. (NASDAQ:ARLZ) Recent Trading Information
ARALEZ PHARMACEUTICALS INC. (NASDAQ:ARLZ) closed its last trading session down -0.15 at 1.71 with 870,014 shares trading hands.