Protalix BioTherapeutics Reports First Quarter 2015 Financial Results
May 07 2015 - 4:30PM
- Losses narrowed by 19%
- Interim data and full results for
PRX-102 expected in the Second Half of 2015
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today
reported financial results for the quarter ended March 31,
2015.
"We continue to execute on our strategy for accelerated growth,
which centers on developing products with clinically superior
profiles and clear competitive advantages," said Moshe Manor,
Protalix's President and Chief Executive Officer. "We have a
number of key milestones anticipated to occur over the next few
quarters that have the potential to create significant shareholder
value. We plan to announce interim and full results from our
phase I/II clinical trial of PRX-102 for the treatment of Fabry
disease during the second half of 2015. Around year-end, we
anticipate holding an end of Phase II meeting with the U.S. Food
and Drug Administration for PRX-102, and initiating proof of
concept clinical trials in patients for both oral antiTNF and AIR
DNase. In the first half of 2016, we expect to launch a
pivotal head-to-head phase III clinical trial of PRX-102 for the
treatment of Fabry disease, and report results from our oral
antiTNF and AIR DNase trials."
Financial Results for the Quarter Ended March 31,
2015
- Net loss narrowed to $6.0 million, or $0.06 per
share, for the first quarter of 2015 down $1.3 million or 19%
from $7.3 million, or $0.08 per share, for the same
period in 2014.
- Total revenues for the first quarter of 2015 were $4.4
million compared to $6.7 million for the first quarter of
2014. The decrease resulted primarily from a decrease of $1.8
million of products sold in Brazil and a decrease of $597,000 of
products we delivered at cost to Pfizer Inc. under our license
agreement.
- During April 2015, we delivered an additional $1.3 million of
products to Brazil.
- Revenue from our share of net income from the collaboration
under the Pfizer agreement increased 3% to $705,000 for the first
quarter 2015 compared to $687,000 for the first quarter of
2014. The increase resulted primarily from the $5.4 million in
revenues generated by Pfizer, mainly in the United States, during
the three months ended March 31, 2015 compared to $4.0 for the
three months ended March 31, 2014.
- Cost of revenues was $2.4 million for the first quarter of
2015, a decrease of $1.7 million or 41%, compared to $4.1
million for the same period in 2014.
- Selling, general and administrative expenses decreased 48% to
$1.9 million for the first quarter of 2015 compared to $3.7 million
for first quarter of 2014. The decrease resulted primarily
from a decrease of $1.0 million in salaries expenses, mainly due to
bonuses that were paid during the first quarter of 2014, and the
devaluation of the New Israeli Shekel against the U.S. dollar
during the period.
- Cash and cash equivalents as of March 31,
2015 were $48.0 million representing cash consumption for
the quarter of approximately $6.8 million.
First Quarter and Recent Operational and Clinical
Highlights
- In January 2015, we announced a new strategy for accelerated
growth focused on developing products with potentially clinically
superior profiles that offer a clear competitive advantage over
other products.
- For PRX-102, we announced completion of enrollment in our Fabry
disease trial on February 2, 2015. We expect to release
interim data from the 1mg/kg dose cohort of the trial during the
third quarter of 2015, with final results to be released by
year-end. We anticipate holding an end of Phase II meeting
with the U.S. Food and Drug Administration around year-end and
intend to launch a phase III head-to-head pivotal trial comparing
PRX-102 to a commercially available enzyme replacement therapy for
the treatment of Fabry disease in early 2016.
- For PRX-106, our oral antiTNF product candidate, a phase I
trial is currently on-going. We expect to select an indication
for the product candidate and to initiate a proof of concept
efficacy study around year-end with results expected in the first
half of 2016.
- We are also currently evaluating clinical sites for our planned
AIR DNase clinical trial, which is expected to first enroll healthy
volunteers and then cystic fibrosis patients. The trial is
being designed to run as a head-to-head study comparing AIR DNase
to Pulmozyme. We expect that this trial will be launched
around year-end with results to be released in the first half of
2016.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the
development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell-based
expression system, ProCellEx®. Protalix's unique expression
system presents a proprietary method for developing recombinant
proteins in a cost-effective, industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase
alfa, was approved for marketing by the U.S. Food and Drug
Administration (FDA) in May 2012,
by Israel's Ministry of Health in September
2012, by the Brazilian National Health Surveillance
Agency (ANVISA) in March 2013, by the Mexican
Federal Commission for the Protection against Sanitary Risk
(COFEPRIS) in April 2013, by the Australian Therapeutic
Goods Administration(TGA) in May 2014 and by the
regulatory authorities of other countries. Marketing
applications for taliglucerase alfa have been filed in additional
territories as well. Protalix has partnered with Pfizer
Inc. for the worldwide development and commercialization of
taliglucerase alfa, excluding Israel and Brazil,
where Protalix retains full rights. Protalix's development
pipeline includes the following product candidates: PRX-102, a
modified version of the recombinant human alpha-GAL-A protein for
the treatment of Fabry disease; PRX-112, an orally-delivered
glucocerebrosidase enzyme that is produced and encapsulated within
carrot cells, also for the treatment of Gaucher disease; PRX-106,
an orally-delivered anti-inflammatory treatment; PRX-110 for the
treatment of Cystic Fibrosis; and others.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. The terms
"anticipate," "believe," "estimate," "expect," "plan" and "intend"
and other words or phrases of similar import are intended to
identify forward-looking statements. These forward-looking
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. These statements are
based on our current beliefs and expectations as to such future
outcomes. Drug discovery and development involve a high degree
of risk. Factors that might cause material differences
include, among others: risks relating to the compliance by Fundação
Oswaldo Cruz with its purchase obligations under our supply and
technology transfer; risks related to the commercialization efforts
for taliglucerase alfa in the United States, Israel, Brazil,
Canada, Australia and other countries; failure or delay in the
commencement or completion of our preclinical and clinical trials
which may be caused by several factors, including: unforeseen
safety issues; determination of dosing issues; lack of
effectiveness during clinical trials; slower than expected rates of
patient recruitment; inability to monitor patients adequately
during or after treatment; inability or unwillingness of medical
investigators and institutional review boards to follow our
clinical protocols; and lack of sufficient funding to finance
clinical trials; the risk that the results of the clinical trials
of our product candidates will not support our claims of safety or
efficacy, that our product candidates will not have the desired
effects or will be associated with undesirable side effects or
other unexpected characteristics; our dependence on performance by
third party providers of services and supplies, including without
limitation, clinical trial services; delays in our preparation and
filing of applications for regulatory approval; delays in the
approval or potential rejection of any applications we file with
the FDA or other health regulatory authorities, and other
risks relating to the review process; the inherent risks and
uncertainties in developing drug platforms and products of the type
we are developing; the impact of development of competing therapies
and/or technologies by other companies and institutions; potential
product liability risks, and risks of securing adequate levels of
product liability and other necessary insurance coverage; and other
factors described in our filings with the U.S. Securities and
Exchange Commission. The statements in this release are valid
only as of the date hereof and we disclaim any obligation to update
this information.
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PROTALIX
BIOTHERAPEUTICS, INC. |
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
(U.S. dollars in
thousands) |
|
|
(Unaudited) |
|
|
|
|
|
|
March 31, 2015 |
December 31,
2014 |
|
|
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ASSETS |
|
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash
equivalents |
$ 47,958 |
$ 54,767 |
|
Accounts receivable -
Trade |
1,816 |
1,884 |
|
Other assets |
2,931 |
2,202 |
|
Inventories |
6,879 |
6,667 |
|
Total current
assets |
59,584 |
65,520 |
|
|
|
|
|
FUNDS IN RESPECT OF
EMPLOYEE RIGHTS UPON RETIREMENT |
1,520 |
1,555 |
|
PROPERTY AND EQUIPMENT,
NET |
10,839 |
11,282 |
|
DEFERRED CHARGES |
105 |
113 |
|
Total assets |
$ 72,048 |
$ 78,470 |
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|
|
|
|
LIABILITIES NET OF CAPITAL
DEFICIENCY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable and
accruals: |
|
|
|
Trade |
$ 5,195 |
$ 3,951 |
|
Other |
14,282 |
15,496 |
|
Deferred revenues |
7,072 |
6,763 |
|
Total current
liabilities |
26,549 |
26,210 |
|
|
|
|
|
LONG TERM LIABILITIES: |
|
|
|
Convertible notes |
67,566 |
67,464 |
|
Deferred revenues |
36,890 |
37,232 |
|
Liability in connection
with collaboration operation |
|
912 |
|
Liability for employee
rights upon retirement |
2,197 |
2,253 |
|
Total long term
liabilities |
106,653 |
107,861 |
|
Total
liabilities |
133,202 |
134,071 |
|
COMMITMENTS |
|
|
|
|
|
|
|
CAPITAL DEFICIENCY |
(61,154) |
(55,601) |
|
Total liabilities
net of capital deficiency |
$ 72,048 |
$ 78,470 |
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PROTALIX
BIOTHERAPEUTICS, INC. |
|
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
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|
(U.S. dollars in
thousands, except per share data) |
|
|
(Unaudited) |
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Three Months
Ended |
|
March 31, 2015 |
March 31, 2014 |
|
|
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REVENUES |
$ 4,392 |
$ 6,696 |
COMPANY'S SHARE IN COLLABORATION
AGREEMENT |
705 |
687 |
COST OF REVENUES |
(2,400) |
(4,073) |
GROSS PROFIT |
2,697 |
3,310 |
RESEARCH AND DEVELOPMENT EXPENSES
(1) |
(6,762) |
(8,152) |
Less –
grants and reimbursements |
1,135 |
2,085 |
RESEARCH AND DEVELOPMENT EXPENSES,
NET |
(5,627) |
(6,067) |
SELLING, GENERAL AND
ADMINISTRATIVE EXPENSES (2) |
(1,913) |
(3,711) |
OPERATING LOSS |
(4,843) |
(6,468) |
FINANCIAL EXPENSES |
(1,157) |
(915) |
FINANCIAL INCOME |
28 |
38 |
FINANCIAL EXPENSES –
NET |
(1,129) |
(877) |
NET LOSS FOR THE PERIOD |
$ (5,972) |
$ (7,345) |
NET LOSS PER SHARE OF COMMON STOCK –
BASIC AND DILUTED |
$ 0.06 |
$ 0.08 |
WEIGHTED AVERAGE NUMBER OF SHARES OF
COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND
DILUTED |
93,200,739 |
92,686,638 |
(1) Includes share-based
compensation |
126 |
428 |
(2) Includes share-based
compensation |
293 |
242 |
|
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CONTACT: Investor Contact
Marcy Nanus
The Trout Group, LLC
646-378-2927
mnanus@troutgroup.com
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