Full Press Release Details
Protalix BioTherapeutics Reports Second
Quarter 2016 Financial Results
Patient Screening Underway for Fabry
Phase III Clinical Trial
Data from the Cystic Fibrosis Phase II
Clinical Trial Expected Around Year-End
CARMIEL, Israel, August 8, 2016 -- Protalix BioTherapeutics,
Inc. (NYSE MKT:PLX) (TASE:PLX), today announced financial results for the fiscal quarter ended June 30, 2016.
"We remain focused on developing our clinical assets,
and now have three drugs being evaluated in clinical trials," said Moshe Manor, Protalix's President and Chief Executive
Officer. "We are currently screening patients in our phase III clinical trial of PRX-102 and anticipate the first patient
being enrolled imminently."
Financial Results for the Period Ended June 30, 2016
Recent Company 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(R). 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 and, subsequently, by the regulatory authorities of other countries. Protalix
has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding 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; OPRX-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: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused
by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing
issues; lack of effectiveness during clinical trials; 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; risks related to the amount and sufficiency of our cash and cash equivalents;
risks relating to the compliance by Funda o Oswaldo Cruz with its purchase obligations and related milestones under
our supply and technology transfer agreement; risks related to the commercialization efforts for taliglucerase alfa in Brazil;
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 SHEET
(U.S. dollars in thousands)
| June 30, 2016 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 54,626 | $ | 76,374 | ||||
| Accounts receivable - Trade | 1,493 | - | ||||||
| Other assets | 5,135 | 1,667 | ||||||
| Inventories | 6,067 | 5,767 | ||||||
| Assets of discontinued operations | 324 | 2,073 | ||||||
| Total current assets | 67,645 | 85,881 | ||||||
| FUNDS IN RESPECT OF EMPLOYEE | ||||||||
| RIGHTS UPON RETIREMENT | 1,739 | 1,628 | ||||||
| PROPERTY AND EQUIPMENT, NET | 9,480 | 9,744 | ||||||
| Total assets | $ | 78,864 | $ | 97,253 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 3,819 | $ | 3,629 | ||||
| Other | 6,844 | 5,534 | ||||||
| Deferred revenues | 504 | 504 | ||||||
| Liabilities of discontinued operations | 293 | 1,568 | ||||||
| Total current liabilities | 11,460 | 11,235 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 68,017 | 67,796 | ||||||
| Deferred revenues | 617 | 744 | ||||||
| Liability for employee rights upon retirement | 2,445 | 2,304 | ||||||
| Promissory note | 4,301 | 4,301 | ||||||
| Total long term liabilities | 75,380 | 75,145 | ||||||
| Total liabilities | 86,840 | 86,380 | ||||||
| COMMITMENTS | ||||||||
| SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | (7,976 | ) | 10,873 | |||||
| Total liabilities and shareholders' equity (net of capital deficiency) | $ | 78,864 | $ | 97,253 |
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, 2016 | June 30, 2015 | June 30, 2016 | June 30, 2015 | |||||||||||||
| REVENUES | $ | 2,448 | $ | 3,028 | $ | 1,769 | $ | 1,336 | ||||||||
| COST OF REVENUES | (2,198 | ) | (507 | ) | (1,675 | ) | (225 | ) | ||||||||
| GROSS PROFIT | 250 | 2,521 | 94 | 1,111 | ||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES (1) | (17,347 | ) | (12,123 | ) | (10,013 | ) | (6,023 | ) | ||||||||
| Less - grants | 3,503 | 2,457 | 2,194 | 1,329 | ||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (13,844 | ) | (9,666 | ) | (7,819 | ) | (4,694 | ) | ||||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) | (4,201 | ) | (3,823 | ) | (2,206 | ) | (2,001 | ) | ||||||||
| OPERATING LOSS | (17,795 | ) | (10,968 | ) | (9,931 | ) | (5,584 | ) | ||||||||
| FINANCIAL EXPENSES | (1,805 | ) | (1,799 | ) | (901 | ) | (642 | ) | ||||||||
| FINANCIAL INCOME | 338 | 71 | 96 | 43 | ||||||||||||
| FINANCIAL EXPENSES - NET | (1,467 | ) | (1,728 | ) | (805 | ) | (599 | ) | ||||||||
| LOSS FROM CONTINUING OPERATIONS | (19,262 | ) | (12,696 | ) | (10,736 | ) | (6,183 | ) | ||||||||
| (LOSS) income FROM DISCONTINUED OPERATIONS | (189 | ) | 1,653 | (117 | ) | 1,112 | ||||||||||
| NET LOSS FOR THE PERIOD | $ | (19,451 | ) | $ | (11,043 | ) | $ | (10,853 | ) | $ | (5,071 | ) | ||||
| NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED: | ||||||||||||||||
| Loss from continuing operations | (0.20 | ) | (0.14 | ) | (0.11 | ) | (0.06 | ) | ||||||||
| Income from discontinued operations | 0.00 | 0.02 | 0.00 | 0.01 | ||||||||||||
| Net loss per share of common stock | $ | (0.20 | ) | $ | (0.12 | ) | $ | (0.11 | ) | $ | (0.05 | ) | ||||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - BASIC AND DILUTED: | 99,737,348 | 93,418,666 | 99,758,511 | 93,635,213 | ||||||||||||
| (1) Includes share-based compensation | $ | 366 | $ | 409 | $ | 128 | $ | 283 | ||||||||
| (2) Includes share-based compensation | $ | 236 | $ | 564 | $ | 99 | $ | 271 |