Full Press Release Details
Protalix BioTherapeutics Reports 2016
Full Year Results and Provides Corporate Update
is projected to Fund the Company through Three Clinical Trial Read-Outs and into 2019
CARMIEL, Israel, March 16, 2017 -- GlobeNewswire /Protalix BioTherapeutics,
Inc. (NYSE MKT:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell-based expression system, ProCellEx , today announced its financial
results for the full-year ended December 31, 2016, and provided a corporate update.
"Recently, our Executive Vice President, Research and
Development and two Principal Investigators that have been involved in our clinical trials of pegunigalsidase alfa for Fabry disease
each gave presentations at the 13th Annual WORLDSymposium in San Diego on the data generated in our phase I/II clinical trial of
pegunigalsidase alfa for the treatment of Fabry disease, and received very positive feedback from physicians and patient advocacy
groups," said Moshe Manor, Protalix's President and Chief Executive Officer. "Looking ahead into 2017,
we anticipate reporting results from both the phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis and
the phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. In 2018, if we generate positive interim results
from the pegunigalsidase phase II trial, we expect to begin the filing process for approval with the European Medicines Agency."
"Following a note exchange and
private placement completed in December 2016, we have a strong cash position of approximately $63.3 million," said Yossi
Maimon, Protalix's Vice President and Chief Financial Officer. "We anticipate these funds will be sufficient to fund
our operations into 2019."
2016 and Recent Clinical and Corporate Highlights
Pegunigalsidase alfa (PRX-102) for Fabry Disease
Alidornase alfa (PRX-110) for Cystic Fibrosis
Oral anti-TNF (OPRX-106) for Ulcerative Colitis
Alfataliglicerase for Gaucher Disease
Full-Year 2016 Financial Results
Conference Call and Webcast Information
The Company will host a conference
call on Thursday, March 16, 2017, at 8:30 am ET to review the clinical, corporate and financial highlights.
To participate in the conference call, please dial the following
numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004.
The conference call will also be broadcast live and available
for replay for two weeks on the Company's website, www.protalix.com, in the Events Calendar of the Investors section.
Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary
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 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: pegunigalsidase alfa, 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;
alidornase alfa for the treatment of Cystic Fibrosis; and others.
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 "expect," "anticipate,
"believe," "estimate," "project," "plan," "should" 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 related to the ultimate purchase by Funda o Oswaldo Cruz of alfataliglicerase pursuant to
the stated purchase intentions of the Brazilian Ministry of Health of the stated amounts, if at all; risks related to
the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of alfataliglicerase
generally; risks related to our commercialization efforts for alfataliglicerase in Brazil; 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 amount and sufficiency of our cash and cash equivalents; risks related to the amount of
our future revenues, operations and expenditures; 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 our ability to obtain stockholder
approval prior to issuing 20% or more of our pre-refinancing outstanding shares of common stock, in compliance with certain listing
standards of the NYSE MKT; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or
to refinance our outstanding notes or any other indebtedness; 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; our ability to identify suitable product candidates and to complete
preclinical studies of such product candidates; 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 press release
are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
The Trout Group, LLC
BioTherapeutics, Inc.
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2015 | 2016 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 76,374 | $ | 63,281 | ||||
| Accounts receivable - Trade | - | 693 | ||||||
| Other assets | 1,667 | 2,321 | ||||||
| Inventories | 5,767 | 5,245 | ||||||
| Assets of discontinued operation | 2,073 | 327 | ||||||
| Total current assets | 85,881 | 71,867 | ||||||
| FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,628 | 1,677 | ||||||
| PROPERTY AND EQUIPMENT, NET | 9,744 | 8,703 | ||||||
| Total assets | $ | 97,253 | $ | 82,247 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 3,629 | $ | 4,007 | ||||
| Other | 5,534 | 7,496 | ||||||
| Convertible notes | - | 53,872 | ||||||
| Deferred revenues | 504 | 837 | ||||||
| Liabilities of discontinued operation | 1,568 | - | ||||||
| Total current liabilities | 11,235 | 66,212 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 67,796 | 19,343 | ||||||
| Deferred revenues | 744 | - | ||||||
| Liability for employee rights upon retirement | 2,304 | 2,348 | ||||||
| Promissory note | 4,301 | 4,301 | ||||||
| Total long term liabilities | 75,145 | 25,992 | ||||||
| Total liabilities | 86,380 | 92,204 | ||||||
| COMMITMENTS (Note 6) | ||||||||
| SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY): | ||||||||
| Common Stock, $0.001 par value: Authorized - as of December 31, 2015 and 2016, 150,000,000 and 250,000,000 shares; issued and outstanding, respectively - as of December 31, 2015 and 2016, 99,800,397 shares and 124,134,085 shares, respectively | 100 | 124 | ||||||
| Additional paid-in capital | 194,064 | 202,575 | ||||||
| Accumulated deficit | (183,291 | ) | (212,656 | ) | ||||
| Total shareholders' equity (capital deficiency) | 10,873 | (9,957 | ) | |||||
| Total liabilities and shareholders' equity (net of capital deficiency) | $ | 97,253 | $ | 82,247 |
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share amounts)
| Year ended December 31, | ||||||||||||
| 2014 | 2015 | 2016 | ||||||||||
| REVENUES | $ | 3,523 | $ | 4,364 | $ | 9,199 | ||||||
| COST OF REVENUES | (630 | ) | (730 | ) | (8,398 | ) | ||||||
| GROSS PROFIT | 2,893 | 3,634 | 801 | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES | (27,352 | ) | (24,889 | ) | (30,412 | ) | ||||||
| Less - grants | 5,128 | 4,864 | 5,804 | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (22,224 | ) | (20,025 | ) | (24,608 | ) | ||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (9,228 | ) | (7,279 | ) | (9,356 | ) | ||||||
| OPERATING LOSS | (28,559 | ) | (23,670 | ) | (33,163 | ) | ||||||
| FINANCIAL EXPENSES | (4,935 | ) | (3,735 | ) | (10,665 | ) | ||||||
| FINANCIAL INCOME | 196 | 123 | 589 | |||||||||
| GAIN ON EXTINGUISHMENT OF CONVERTIBLE NOTES | 14,063 | |||||||||||
| FINANCIAL INCOME (EXPENSES) - NET | (4,739 | ) | (3,612 | ) | 3,987 | |||||||
| LOSS FROM CONTINUING OPERATIONS | (33,298 | ) | (27,282 | ) | (29,176 | ) | ||||||
| (LOSS) Income FROM DISCONTINUED OPERATIONS | 3,355 | 85,319 | (189 | ) | ||||||||
| NET INCOME (LOSS) FOR THE YEAR | $ | (29,943 | ) | $ | 58,037 | $ | (29,365 | ) | ||||
| Net INCOME (loss) per share of common stock - basic and diluted | ||||||||||||
| Loss from continuing operations | $ | (0.36 | ) | $ | (0.29 | ) | $ | (0.29 | ) | |||
| Income from discontinued operations | 0.04 | 0.90 | (0.00 | ) | ||||||||
| Net (loss) income per share of common stock | $ | (0.32 | ) | $ | 0.61 | $ | (0.29 | ) | ||||
| Weighted average number of shares of common stock used in computing loss per share of common stock, basic and diluted | 92,891,846 | 94,922,390 | 101,387,704 |