MISSISSAUGA,
ON, July 30, 2014 /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 second
quarter ended June 30, 2014.
WF10 Phase 2 Clinical Trial Update
The enrolment for the Phase 2 WF10 clinical trial for the treatment
of allergic rhinitis commenced in March
2014 and to-date, 121 patients have been enrolled at 15
sites in Germany. Enrolment
was slower than anticipated due to a late onset to the allergy
season in Germany. The trial
is a 160-subject, randomized, double blind, placebo-controlled,
4-arm multi-centre trial to assess the efficacy and safety of a
regimen of five WF10 infusions for the treatment of patients with
moderate to severe persistent allergic rhinitis. The Company
expects the study to be completed in late 2014 with top-line
results available in the first quarter of 2015.
Table of Selected Financial Results
For further details on the results, please refer to Nuvo's
Management, Discussion and Analysis (MD&A) and Condensed
Consolidated Interim Financial Statements which are available on
the Company's website (www.nuvoresearch.com).
|
|
Three months
ended |
|
Six months
ended |
|
|
June
30,
2014 |
|
June
30,
2013 |
|
Change |
|
June
30,
2014 |
|
June
30,
2013 |
|
Change |
(Canadian dollars
in thousands,
except per share and share figures) |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
Revenue |
|
3,863 |
|
3,320 |
|
543 |
|
6,620 |
|
5,571 |
|
1,049 |
Operating Expenses |
|
6,034 |
|
5,624 |
|
410 |
|
11,677 |
|
11,040 |
|
637 |
Net loss |
|
(2,307) |
|
(2,220) |
|
(87) |
|
(5,050) |
|
(5,490) |
|
440 |
Per share - basic and diluted |
|
(0.23) |
|
(0.25) |
|
|
|
(0.53) |
|
(0.63) |
|
|
Q2 Financial Highlights
Revenue, consisting of product sales, royalties, license fee
revenue and research and other contract revenue for the three
months ended June 30, 2014 was
$3.9 million compared to $3.3 million for the three months ended
June 30, 2013. The increase was
attributable to higher product sales of Pennsaid 2% to support the
launch in the U.S. and higher Pennsaid product sales to our
distributors outside of the U.S. Total revenue for the six
months ended June 30, 2014 was
$6.6 million compared to $5.6 million in the comparative period.
Total operating expenses for the three months
ended June 30, 2014 increased to
$6.0 million from $5.6 million for the three months ended
June 30, 2013. The increase was
primarily due to higher General and Administrative (G&A) costs
in the quarter. Total operating expenses for the six months
ended June 30, 2014 increased to
$11.7 million from $11.0 million in the comparative period.
Cost of Goods Sold (COGS) was unchanged at
$1.5 million for the three months
ended June 30, 2014 and June 30, 2013. The Company's gross margin
on product sales increased to $0.7
million compared to $0.2
million in the comparative period, due to an increase in
Pennsaid and Pennsaid 2% product sales in the quarter. Gross
margin as a percent of product sales increased in the quarter to
32% from 9% in the comparative period. For the six months
ended June 30, 2014, COGS increased
to $2.7 million compared to
$2.5 million for the six month ended
June 30, 2013.
Research and Development expenses were unchanged
at $1.5 million and $3.4 million for the three and six months ended
June 30, 2014 and June 30, 2013. In the quarter, the costs
associated with the Company's Phase 2 clinical trial for WF10 were
offset by the savings realized from the closure of the Company's
facility in Salt Lake City and the
TPT Group office in 2013.
G&A expenses were $2.9 million for the three months ended
June 30, 2014 compared to
$2.3 million for the three months
ended June 30, 2013. The
increase in the quarter related to an increase in stock-based
compensation and professional fees related to the Company's
litigation with Mallinckrodt, partially
offset by a decrease in non-cash charges related to amortization of
the Company's intangible assets. G&A expenses for the six
months ended June 30, 2014 were
$5.3 million compared to $4.6 million for the six months ended
June 30, 2013.
Net loss was $2.3
million for the three months ended June 30, 2014 compared to $2.2 million for the three months ended
June 30, 2013. The increase in
revenue in the quarter was offset by higher operating expenses and
a foreign currency loss in the quarter compared to a foreign
currency gain in the comparative period. Net loss was
$5.1 million for the six months ended
June 30, 2014 compared to
$5.5 million for the six months ended
June 30, 2013.
Cash and cash equivalents were $10.7 million as at June
30, 2014 compared to $12.6
million as at December 31,
2013.
Cash used in operating activities increased to
$2.7 million for the three months
ended June 30, 2014 compared to
$2.0 million for the three months
ended June 30, 2013. The
increase was primarily due to higher investment in non-cash working
capital in the quarter related to an increase in accounts
receivable due to greater Pennsaid and Pennsaid 2% product
sales. For the six months ended June
30, 2014, cash used in operating activities was $3.6 million compared to $3.8 million for the six months ended
June 30, 2013.
Net cash used in financing activities totaled
$0.7 million for the three months
ended June 30, 2014 compared to
$0.5 million for the three months
ended June 30, 2013. During both
periods, the Company made repayments on finance, lease and other
obligations. Net cash provided by financing activities
totaled $1.7 million for the six
months ended June 30, 2014 compared
to net cash used in financing activities of $0.9 million for the six months ended
June 30, 2013.
The number of common shares outstanding as at
June 30, 2014 was 10,239,619.
Pennsaid and Pennsaid 2% in the U.S.
According to IMS Health, a provider of dispensed prescription data,
during the second quarter of 2014, U.S. prescriptions of Pennsaid
2% were 18,000 with an average of 1.23 bottles per script compared
to 6,000 prescriptions in the first quarter of 2014. Pennsaid
2% was launched on February 10,
2014. Pennsaid prescriptions were 14,000 in the three
months ended June 30, 2014, a 42%
decrease from the prescriptions in the first quarter of 2014. The
decrease in Pennsaid prescriptions was related to the launch of
Pennsaid 2% as Mallinckrodt is working
to switch the market from Pennsaid to Pennsaid 2% and the launch of
a generic version of Pennsaid in the U.S. in May 2014.
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 has four
U.S. Food and Drug Administration (FDA) approved commercial
products, a pipeline of topical and transdermal products focusing
on pain and dermatology and four 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, a development program for the treatment of
allergic rhinitis and an immune system modulation platform that has
the potential to support treatments for a broad range of immune
system related disorders. For additional company information
visit www.nuvoresearch.com.
Forward-Looking Statements
Certain statements in this news release constitute
forward-looking statements within the meaning of applicable
securities laws. Forward-looking statements include, but are not
limited to the Company's anticipated use of proceeds from the
Private Placement, the Company's future share price and the
Company's possible election to accelerate the expiry date of any of
the warrants or the brokers warrants 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 20,
2014 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 news 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 news release are qualified by these cautionary statements. The
forward-looking statements contained herein are made as of the date
of this news 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.