Full Press Release Details
Protalix BioTherapeutics Reports 2017
First Quarter Results and Provides Corporate Update
from Phase II Trial in CF Program with Number of Potential Strategic Alternatives for Further Development
Monthly Dosing Trial in Fabry Patients to Commence Next Quarter
in the Commercialization of alfataliglicerase in Brazil
CARMIEL, Israel, May 10, 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 three months ended March 31, 2017 and provided a corporate update.
"This quarter we remained focused on driving our lead clinical
asset pegunigalsidase alfa through clinical development including FDA clearance of our IND for the first ever once monthly dose
of pegunigalsidase alfa. This will further differentiate pegunigalsidase and its potential superiority to currently available therapies.
We also announced very strong, positive results for alidornase alfa from our Phase II study in Cystic Fibrosis," said Moshe
Manor, President and CEO of Protalix. "Additionally, in the first quarter we recorded increased revenue from sales of alfataliglicerase
in Brazil and we anticipate revenues will further increase significantly throughout the year."
2017 First Quarter 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
Three Months ended March 31, 2017 Financial Results
Conference Call and Webcast Information
The Company will host a conference
call on Wednesday, May 10, 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. Conference ID number
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 audio
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 superiority, 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 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| March 31, 2017 | December 31, 2016 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 48,017 | $ | 63,281 | ||||
| Accounts receivable - Trade | 2,737 | 693 | ||||||
| Other assets | 3,484 | 2,321 | ||||||
| Inventories | 7,100 | 5,245 | ||||||
| Assets of discontinued operation | 205 | 327 | ||||||
| Total current assets | 61,543 | 71,867 | ||||||
| FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,837 | 1,677 | ||||||
| PROPERTY AND EQUIPMENT, NET | 8,472 | 8,703 | ||||||
| Total assets | $ | 71,852 | $ | 82,247 | ||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 5,999 | $ | 4,007 | ||||
| Other | 12,365 | 7,496 | ||||||
| Convertible notes | 53,872 | |||||||
| Deferred revenues | 1,925 | 837 | ||||||
| Total current liabilities | 20,289 | 66,212 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 113,204 | 19,343 | ||||||
| Liability for employee rights upon retirement | 2,528 | 2,348 | ||||||
| Promissory note | 4,301 | 4,301 | ||||||
| Total long term liabilities | 120,033 | 25,992 | ||||||
| Total liabilities | 140,322 | 92,204 | ||||||
| COMMITMENTS | ||||||||
| CAPITAL DEFICIENCY | (68,470 | ) | (9,957 | ) | ||||
| Total liabilities net of capital deficiency | $ | 71,852 | $ | 82,247 |
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share
| Three Months Ended | ||||||||
| March 31, 2017 | March 31, 2016 | |||||||
| REVENUES | $ | 2,889 | $ | 679 | ||||
| COST OF REVENUES | (2,088 | ) | (523 | ) | ||||
| GROSS PROFIT | 801 | 156 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES (1) | (5,967 | ) | (7,334 | ) | ||||
| Less - grants | 1,338 | 1,309 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (4,629 | ) | (6,025 | ) | ||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) | (2,537 | ) | (1,995 | ) | ||||
| OPERATING LOSS | (6,365 | ) | (7,864 | ) | ||||
| FINANCIAL EXPENSES | (2,087 | ) | (904 | ) | ||||
| FINANCIAL INCOME | 1,625 | 242 | ||||||
| LOSS FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES embedded derivative | (52,321 | ) | ||||||
| FINANCIAL EXPENSES, NET | (52,783 | ) | (662 | ) | ||||
| LOSS FROM CONTINUING OPERATIONS | (59,148 | ) | (8,526 | ) | ||||
| LOSS FROM DISCONTINUED OPERATIONS | (72 | ) | ||||||
| NET LOSS FOR THE PERIOD | $ | (59,148 | ) | $ | (8,598 | ) | ||
| NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED | ||||||||
| Loss from continuing operations | $ | (0.48 | ) | $ | (0.09 | ) | ||
| Loss from discontinued operations | (0.00 | ) | ||||||
| Net loss per share of common stock | $ | (0.48 | ) | $ | (0.09 | ) | ||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND DILUTED | 124,467,602 | 99,715,625 | ||||||
| (1) Includes share-based compensation | 65 | 238 | ||||||
| (2) Includes share-based compensation | 53 | 137 |