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Protalix BioTherapeutics Reports First Quarter 2015 Financial Results - Losses narrowed by 19% - Interim data and full results for PRX-102 expected in the Second Half of 2015

Key Takeaway: Protalix BioTherapeutics Reports First Quarter 2015 Financial Results - Losses narrowed by 19% - Interim data and full results for PRX-102 expected in the Second Half of 2015 CARMIEL, Israel, May 7, 2015 -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today repo

Full Press Release Details

Protalix BioTherapeutics Reports First
Quarter 2015 Financial Results
- Losses narrowed by 19%
- Interim data and full results for PRX-102 expected in the Second Half of 2015
CARMIEL, Israel, May 7, 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,
First Quarter and Recent Operational and Clinical Highlights
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 Funda o
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.
The Trout Group, LLC
Source: Protalix BioTherapeutics, Inc.
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
March 31, 2015 December 31, 2014
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
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
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
Three Months Ended
March 31, 2015 March 31, 2014
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
Last updated: May 7, 2015