- US$7.0 million
purchase price funded from existing cash -
- Immediately
accretive acquisition -
MISSISSAUGA, ON, Jan. 2, 2018 /PRNewswire/ - Nuvo Pharmaceuticals
Inc. (Nuvo or the Company) (TSX: NRI; OTCQX: NRIFF), a commercial
healthcare company with a portfolio of commercial products and
pharmaceutical manufacturing capabilities, today announced it has
acquired the global, ex-U.S. (the Territory) rights to
Resultz® (50% isopropyl myristate, 50% cyclomethicone D5
topical solution lice and egg removal kit) from Piedmont
Pharmaceuticals LLC (Piedmont).
The transaction includes existing royalty streams in the
Royalty Markets (as defined below) and all product and intellectual
property (IP) rights in the Territory.
Resultz is a commercial-stage, best-in-class, clinically proven,
safe, non-pesticide, over-the-counter (OTC) treatment for head
lice. This market-leading product is currently sold in
several European markets, including France, Spain, Portugal, Belgium, Ireland and the United Kingdom, as well as Canada, Russia, Australia and Israel (collectively the Royalty Markets),
through a network of existing license agreements and partners that
will be assumed by Nuvo. Aggregate net sales of Resultz in
the Royalty Markets, for the twelve months ending September 2017, were approximately US$16.0 million generating royalty payments of
approximately US$1.5 million.
Resultz is currently approved for sale under its European
Conformity (CE) mark as a class 1 medical device, but not yet
partnered or launched in all remaining E.U. territories, including
the key markets of Germany,
Italy, the Netherlands, Scandinavia and Greece.
The current head lice market in the remaining E.U. territories was
valued at approximately US$150
million in 2016. Resultz has not been partnered or
approved in most rest of world markets, including the Middle East and Africa, Latin
America and Asia Pacific
(outside of Japan and Australia). However, the European CE
mark is recognized in many of these markets and may facilitate
class 1 medical device registration procedures via local
partners. With a global head lice prevalence of approximately
6%, the market opportunity for Resultz in all non-Royalty Markets
is attractive and growing. This transaction is immediately
accretive and provides Nuvo with an additional global product that,
alongside existing manufacturing partners, can be produced at
Nuvo's Varennes, Québec
manufacturing site.
"This is an exciting day for Nuvo," said Jesse Ledger, Nuvo's President & CEO.
"The addition of the Resultz brand to our global product portfolio
is an example of the disciplined transactions we are pursuing to
make Nuvo a more diversified and profitable company. Resultz
checks all of the boxes for an ideal new Nuvo product: it is
approved, has commercialized-generating royalty revenue, broad
global IP protection, provides significant opportunity for global
geographic expansion and revenue growth and can be manufactured in
our Varennes, Québec
facility."
Purchase Agreement Details
Under the terms of the
agreement, Nuvo has paid US$7.0
million on close to Piedmont. The transaction also includes
a single-digit royalty payable by Nuvo on net sales generated from
non-Royalty Markets through 2023 and potential added future
consideration in the form of payments for achieving certain
aggregate annual net sales-based milestones.
Stifel, Nicolaus & Company, Incorporated acted as exclusive
financial advisor to Piedmont Pharmaceuticals LLC in this
transaction.
About Resultz
Resultz is a pesticide-free pediculicide
rinse which was originally developed by Piedmont that addresses the challenge of
increasing pesticide resistance in lice and concerns about patient
safety through exposure to pesticides. In as little as a
5-minute application (the shortest treatment time for head lice
products), Resultz acts to disrupt the wax covering of the head
louse resulting in their dehydration and death. Resultz lice
and egg removal kit facilitates removal of lice, nymphs and nits
with efficacy of up to 100%. If necessary, a second
application approximately 7-10 days later will eliminate any
remaining lice. The Resultz lice and egg removal kit and its
unique physical mechanism of action allows Resultz to work even
with pesticide resistant super lice. Resultz is indicated for
treating both children and adults. It has an excellent safety
profile and contains active ingredients commonly found in many
cosmetic products. Resultz was first launched as a medical
device in the United Kingdom and
Ireland in 2005 and more than ten
million patients have been treated globally to-date. Current
global licensees include Reckitt Benckiser Group PLC, Aralez
Pharmaceuticals Inc. and Lapidot Medical. Resultz is also
pending registration in Japan,
where the local license is held by Sato Pharmaceutical Co.
Ltd. Resultz is protected by a robust portfolio of 40 issued
patents globally.
About Piedmont Pharmaceuticals LLC
Piedmont
Pharmaceuticals is committed to continuing to grow the Resultz
Brand globally. It is closely affiliated with Piedmont Animal
Health LLC which at one time was a wholly owned subsidiary.
Piedmont Animal Health is a Greensboro, N.C.-based companion animal
pharmaceutical development and marketing company focused on
inventing and developing innovative technologies to address
veterinary healthcare needs. Piedmont's founders have developed, launched,
and/or marketed over 20 FDA Rx companion animal products for dogs,
cats, and horses, including four innovative products developed and
launched in the U.S. by Piedmont Animal Health in the last four
years. The company is currently developing a broad range of
convenient and long-acting medications, including ones focusing on
the therapeutic areas of pain management and anti-infectives.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX: NRI; OTCQX:
NRIFF) is a commercial healthcare company with a portfolio of
commercial products and pharmaceutical manufacturing
capabilities. Nuvo has three commercial products that are
available in a number of countries; Pennsaid 2%, Pennsaid and the
heated lidocaine/tetracaine patch. Pennsaid 2% is sold
in the U.S. by Horizon Pharma plc (NASDAQ: HZNP) and is available
for partnering in certain other territories around the world.
Nuvo manufactures Pennsaid for the global market and Pennsaid 2%
for the U.S. market at its FDA, Health Canada and E.U. approved
manufacturing facility in Varennes, Québec. For additional
information, please visit www.nuvopharmaceuticals.com.
Forward-Looking Statements
This Press Release
contains "forward-looking statements" within the meaning of
applicable securities laws. Forward-looking statements can be
identified by words such as: "anticipate," "intend," "plan,"
"goal," "seek," "believe," "project," "estimate," "expect,"
"strategy," "future," "likely," "may," "should," "will" and similar
references to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
the Company's current beliefs, expectations and assumptions
regarding the future of its business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of the Company's control. Nuvo's actual results
and financial condition may differ materially from those indicated
in the forward-looking statements. Therefore, readers should not
rely on any of these forward-looking statements. Important factors
that could cause Nuvo's actual results and financial condition to
differ materially from those indicated in the forward-looking
statements include, among others, the risk factors included in
Nuvo's most recent Annual Information Form dated March 1, 2017 under the heading "Risks Factors",
and as described from time to time in the reports and disclosure
documents filed by Nuvo with Canadian securities regulatory
agencies and commissions. These and other factors should be
considered carefully and readers should not place undue reliance on
Nuvo's forward-looking statements. As a result of the foregoing and
other factors, no assurance can be given as to any such future
results, levels of activity or achievements and none of Nuvo or any
other person assumes responsibility for the accuracy and
completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this
Press Release is based only on information currently available to
it and speaks only as of the date on which it is made. Except as
required by applicable securities laws, Nuvo undertakes no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
SOURCE Nuvo Pharmaceuticals Inc.