Full Press Release Details
Protalix BioTherapeutics Reports Full
Year 2014 Financial Results
and Provides Corporate Update
CARMIEL, Israel, March 12, 2015 -- Protalix
BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the year ended December 31, 2014 and
provided an update on recent corporate developments.
for the Year Ended December 31, 2014
Corporate Update and Operation Highlights
"We continue to work closely with Pfizer, the Gaucher
community and payors to increase ELELYSO market share across all territories. While this growth has been slower than anticipated,
the number of patients on drug continues to increase steadily year over year," said Moshe Manor, Protalix's President
and Chief Executive Officer. "On the clinical development front, we are very excited about the potential of PRX-102 to treat
Fabry disease. This sentiment was echoed by the physician community at the WORLD annual meeting last month, where the positive
interim results from the first dosing cohort were presented. In 2015, we look forward to announcing additional interim and full
results from the PRX-102 phase I/II clinical trial and commencing proof of concept studies for oral antiTNF and AIR DNase."
About Protalix BioTherapeutics,
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.
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 BioTherapuetics
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share amounts)
| December 31, | ||||||||
| 2013 | 2014 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 86,398 | $ | 54,767 | ||||
| Accounts receivable- Trade | 2,091 | 1,884 | ||||||
| Other assets | 1,457 | 2,202 | ||||||
| Inventories | 7,957 | 6,667 | ||||||
| Total current assets | 97,903 | 65,520 | ||||||
| FUNDS IN RESPECT OF EMPLOYEE | ||||||||
| RIGHTS UPON RETIREMENT | 1,578 | 1,555 | ||||||
| PROPERTY AND EQUIPMENT, NET | 13,711 | 11,282 | ||||||
| DEFERRED CHARGES | 141 | 113 | ||||||
| Total assets | $ | 113,333 | $ | 78,470 | ||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 5,254 | $ | 3,951 | ||||
| Other | 12,073 | 15,496 | ||||||
| Deferred revenues | 9,369 | 6,763 | ||||||
| Total current liabilities | 26,696 | 26,210 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 67,048 | 67,464 | ||||||
| Deferred revenues | 41,796 | 37,232 | ||||||
| Liability in connection with collaboration operation | 2,371 | 912 | ||||||
| Liability for employee rights upon retirement | 2,368 | 2,253 | ||||||
| Total long term liabilities | 113,583 | 107,861 | ||||||
| Total liabilities | 140,279 | 134,071 | ||||||
| COMMITMENTS | ||||||||
| CAPITAL DEFICIENCY: | ||||||||
| Common Stock, $0.001 par value: | ||||||||
| Authorized - as of December 31, 2013 and 2014, | ||||||||
| 150,000,000 shares; issued and outstanding - as of December 31, 2013 and 2014, 93,551,098 shares and 93,603,819 shares, respectively | 93 | 94 | ||||||
| Additional paid-in capital | 184,346 | 185,633 | ||||||
| Accumulated deficit | (211,385 | ) | (241,328 | ) | ||||
| Total capital deficiency | (26,946 | ) | (55,601 | ) | ||||
| Total liabilities net of capital deficiency | $ | 113,333 | $ | 78,470 |
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except shares and per share amounts)
| Year ended December 31, | ||||||||
| 2013 | 2014 | |||||||
| REVENUES | $ | 10,479 | $ | 13,651 | ||||
| COMPANY'S SHARE IN COLLABORATION AGREEMENT | 1,034 | 1,509 | ||||||
| COST OF REVENUES | (5,428 | ) | (9,053 | ) | ||||
| GROSS PROFIT | 6,085 | 6,107 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES | (33,313 | ) | (29,761 | ) | ||||
| Less - grants and reimbursements | 8,497 | 8,111 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (24,816 | ) | (21,650 | ) | ||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (8,385 | ) | (9,661 | ) | ||||
| OPERATING LOSS | (27,116 | ) | (25,204 | ) | ||||
| FINANCIAL EXPENSES | (1,065 | ) | (4,935 | ) | ||||
| FINANCIAL INCOME | 391 | 196 | ||||||
| FINANCIAL INCOME (EXPENSES) - NET | (674 | ) | (4,739 | ) | ||||
| NET LOSS FOR THE YEAR | $ | (27,790 | ) | $ | (29,943 | ) | ||
| Net loss per share of common stock - basic and diluted | $ | (0.30 | ) | $ | (0.32 | ) | ||
| Weighted average number of shares of common | ||||||||
| stock used in computing loss per share of | ||||||||
| common stock, basic and diluted | 92,368,138 | 92,891,846 |