MISSISSAUGA, ON, May 12, 2015 /PRNewswire/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced its
financial and operational results for the first quarter ended
March 31, 2015.
First Quarter and Recent Corporate
Developments:
WF10™
- In January, the Company announced topline results of its Phase
2 trial to investigate the safety and efficacy of WF10 in patients
with refractory allergic rhinitis. The WF10 arm and the 2 separate
arms that included constituent elements of WF10 all demonstrated a
reduction in allergy symptoms and performed better than placebo;
however, due to an unexpectedly strong placebo response, the
differences from placebo were not statistically significant;
and
- In April, the Company announced it would conduct a new Phase 2
trial using WF10 for the treatment of allergic rhinitis.
Commencement of the trial, which is subject to Canadian regulatory
approval, is expected in Q2 2015 with topline results expected in
Q4 2015 or Q1 2016.
Pennsaid®2%
- The Company anticipates that its Phase 3 trial in Germany of Pennsaid 2% for the treatment of
acute pain to support regulatory approval applications for Pennsaid
2% in international jurisdictions will commence in Q2 2015, subject
to German regulatory approval, with topline results expected Q4
2015 or Q1 2016.
Table of Selected Financial Results
For further
details on the results, please refer to the Management, Discussion
and Analysis (MD&A) and Consolidated Financial Statements which
are available on the Company's website (www.nuvoresearch.com).
|
Three months
ended
|
|
March
31,
2015
|
March 31,
2014
|
Change
|
(Canadian dollars
in millions)
|
$
|
$
|
$
|
Revenue
|
4.5
|
2.8
|
1.7
|
Operating
Expenses
|
5.1
|
5.6
|
(0.5)
|
Net loss
|
(0.3)
|
(2.7)
|
2.4
|
Per share – basic and
diluted
|
(0.03)
|
(0.31)
|
|
Q1 Financial Highlights
Revenue, consisting of product
sales, royalties, license fee revenue and research and other
contract revenue for the three months ended March 31, 2015 was $4.5
million compared to $2.8
million for the three months ended March 31, 2014. The increase in revenue was
primarily related to higher Pennsaid 2% product sales to Horizon
plc (Horizon) in the U.S. market to support their launch of
Pennsaid 2%, combined with increased Pennsaid product sales to our
distributor in Greece. The increase in product sales was
partially offset by a decrease in royalty revenues as the Company
does not earn royalty revenue on Horizon's net sales of Pennsaid 2%
in the U.S. market as it did prior to January 1, 2015 on net sales by its previous U.S.
marketing licensee, Mallinckrodt.
Total operating expenses for the three months ended March 31, 2015 decreased to $5.1 million versus $5.6
million for the three months ended March 31, 2014. The decrease in operating
expenses was primarily due to the revaluation of cash settled
stock-based compensation (SBC) costs which are primarily included
in general and administrative (G&A) costs for the quarter,
partially offset by increased cost of goods sold (COGS) due to a
greater volume of production sales.
COGS for the three months ended March 31,
2015 was $2.6 million compared
to $1.2 million for the three months
ended March 31, 2014. The
increase in COGS was associated with increased Pennsaid and
Pennsaid 2% product sales. The increase in product sales
improved the gross margin to $1.3
million for the three months ended March 31, 2015 compared to a negative margin of
$0.1 million for the three months
ended March 31, 2014. For the
three months ended March 31, 2015,
the gross margin as a percentage of product sales was 34%.
Research and development (R&D) expenses increased to
$2.0 million for the three months
ended March 31, 2015 compared to
$1.9 million for the three months
ended March 31, 2014. The
increase in the quarter related to costs associated with the
Pennsaid 2% Phase 3 trial for the treatment of acute pain to
support regulatory approval applications for Pennsaid 2% in
international jurisdictions.
G&A expenses decreased to $0.7
million for the three months ended March 31, 2015 compared to $2.4 million for the three months ended
March 31, 2014. The decrease in
the quarter was related to decrease in SBC primarily from the
revaluation of cash settled SBC to market value. Excluding
this impact, G&A expenses were consistent with the comparative
period at $2.1 million.
Net loss was $0.3 million for the
three months ended March 31, 2015
compared to $2.7 million for the
three months ended March 31,
2014. The improvement in net loss in the current period was
attributable to higher Pennsaid and Pennsaid 2% product revenue and
a decrease in operating expenses in the current period, offset by
lower royalty revenues.
Cash and short-term investments was $56.8
million at March 31, 2015, a
decrease of $1.5 million compared to
$58.3 million at December 31, 2014.
Cash used in operating activities was $1.7 million for the three months ended
March 31, 2015 compared to
$0.9 million for the three months
ended March 31, 2014. In the
quarter, the Company used $0.2
million of cash in its operations and invested $1.4 million in non-cash working capital.
In the comparative period, the Company used $2.7 million of cash in its operations and
recovered $1.8 million of non-cash
working capital.
The number of common shares outstanding as at March 31, 2015 was 10,854,989.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty
pharmaceutical company with a diverse portfolio of products and
technologies. The Company operates two distinct business units: the
Topical Products and Technology (TPT) Group and the Immunology
Group. The TPT Group currently has four commercial products,
a pipeline of topical and transdermal products focusing on pain and
dermatology and multiple drug delivery platforms that support the
development of patented formulations that can deliver actives into
or through the skin. The Immunology Group has two commercial
products and an immune system modulation platform that supports the
development of drug products that modulate chronic inflammation
processes resulting in a therapeutic benefit. For additional
company information visit www.nuvoresearch.com.
Forward-Looking Statements
Certain statements in
this press release constitute forward-looking statements within the
meaning of applicable securities laws. Forward-looking
statements include, but are not limited to statements concerning
the Company's future objectives, strategies to achieve those
objectives, as well as statements with respect to management's
beliefs, plans, estimates, and intentions, and similar statements
concerning anticipated future events, results, circumstances,
performance or expectations that are not historical facts.
Forward-looking statements generally can be identified by the use
of forward-looking terminology such as "outlook", "objective",
"may", "will", "expect", "intend", "estimate", "anticipate",
"believe", "should", "plans" or "continue", or similar expressions
suggesting future outcomes or events. Such forward-looking
statements reflect management's current beliefs and are based on
information currently available to management.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
contemplated by such statements. Factors that could cause
such differences include general business and economic
uncertainties and adverse market conditions as well as other risk
factors included in the Company's Annual Information Form dated
February 19, 2015 under the heading
"Risks Factors" and as described from time to time in the reports
and disclosure documents filed by the Company with Canadian
securities regulatory agencies and commissions. This list is
not exhaustive of the factors that may impact the Company's
forward-looking statements. These and other factors should be
considered carefully and readers should not place undue reliance on
the Company'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 neither
the Company nor any other person assumes responsibility for the
accuracy and completeness of these forward-looking
statements. The factors underlying current expectations are
dynamic and subject to change. Although the forward-looking
information contained in this press release is based upon what
management believes are reasonable assumptions, there can be no
assurance that actual results will be consistent with these
forward-looking statements. All forward-looking statements in
this press release are qualified by these cautionary
statements. The forward-looking statements contained herein
are made as of the date of this press release and except as
required by applicable law, the Company undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
SOURCE Nuvo Research Inc.