Full Press Release Details
Protalix BioTherapeutics
Reports Second Quarter 2019 Results
and Provides Corporate Update
CARMIEL, Israel, August
8, 2019 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American: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 six-month period
ended June 30, 2019 and provided a corporate update.
"We are very optimistic about
our interactions with the U.S. Food and Drug Administration over the second quarter of 2019, which resulted in our decision
to, together with our partner Chiesi Farmaceutici, begin
preparing a biologics license application for pegunigalsidase alfa for the treatment of Fabry
disease, which we expect to submit in the first quarter of 2020 through the FDA's Accelerated Approval pathway," said
Mr. Dror Bashan, Protalix's President and Chief Executive Officer. "We
are now focused on completing the anticipated filing."
Second Quarter 2019 and Recent Clinical and
Corporate Highlights
Financial Results for the Six
Months Ended June 30, 2019
Conference Call and Webcast Information
The Company will host a conference
call on Thursday, August 8, 2019, 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 1497319.
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 software.
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. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and
outside the United States, for the development and commercialization of pegunigalsidase alfa.
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 and the final results of a clinical trial may be different than the preliminary findings
for the clinical trial. 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: risks that the FDA will
not accept an application for accelerated approval of PRX-102 with the data generated to date or will request additional data or
other conditions of our submission of any application for accelerated approval of PRX-102; risks related to our ability to continue
as a going concern absent access to sources of capital we will need to finance future research and development activities, general
and administrative expenses and working capital; risks related to any capital raising transactions we may effect in the public
or private equity markets to raise capital to finance future research and development activities, general and administrative expenses
and working capital; 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 related to our ability to maintain and manage our relationship
with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount and sufficiency of our
cash and cash equivalents; 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; the risk that despite the FDA's grant of fast track designation for pegunigalsidase alfa for the treatment
of Fabry disease, we may not experience a faster development process, review or approval compared to applications considered for
approval under conventional FDA procedures; risks related to the FDA's ability to withdraw the fast track designation at
any time; 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.
Source: Protalix BioTherapeutics, Inc.
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| June 30, 2019 (Unaudited) | December 31, 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 25,096 | $ | 37,808 | ||||
| Accounts receivable - Trade | 7,256 | 4,729 | ||||||
| Other assets | 2,248 | 1,877 | ||||||
| Inventories | 6,998 | 8,569 | ||||||
| Total current assets | $ | 41,598 | $ | 52,983 | ||||
| FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | $ | 1,871 | $ | 1,758 | ||||
| PROPERTY AND EQUIPMENT, NET | 5,917 | 6,390 | ||||||
| OPERATING LEASE RIGHT OF USE ASSETS | 5,856 | - | ||||||
| Total assets | $ | 55,242 | $ | 61,131 | ||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 6,728 | $ | 5,211 | ||||
| Other | 10,496 | 10,274 | ||||||
| Operating lease liabilities | 1,227 | - | ||||||
| Contracts liability | 7,542 | 9,868 | ||||||
| Total current liabilities | $ | 25,993 | $ | 25,353 | ||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | $ | 49,401 | $ | 47,966 | ||||
| Contracts liability | 34,911 | 33,027 | ||||||
| Liability for employee rights upon retirement | 2,508 | 2,374 | ||||||
| Operating lease liabilities | 4,566 | - | ||||||
| Other long term liabilities | 5,348 | 5,292 | ||||||
| Total long term liabilities | $ | 96,734 | $ | 88,659 | ||||
| Total liabilities | $ | 122,727 | $ | 114,012 | ||||
| COMMITMENTS | ||||||||
| CAPITAL DEFICIENCY | $ | (67,485 | ) | $ | (52,881 | ) | ||
| Total liabilities net of capital deficiency | $ | 55,242 | $ | 61,131 |
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, 2019 | June 30, 2018 | June 30, 2019 | June 30, 2018 | |||||||||||||
| REVENUES FROM SELLING GOODS | $ | 6,960 | $ | 6,559 | $ | 3,430 | $ | 2,006 | ||||||||
| REVENUES FROM LICENSE AND | ||||||||||||||||
| R&D SERVICES | 15,726 | 4,993 | 8,817 | 2,832 | ||||||||||||
| COST OF GOODS SOLD | (4,740 | ) | (5,107 | ) | (2,695 | ) | (2,183 | ) | ||||||||
| RESEARCH AND DEVELOPMENT | ||||||||||||||||
| EXPENSES (1) | (25,024 | ) | (14,762 | ) | (13,323 | ) | (7,476 | ) | ||||||||
| Less - grants | 3 | 1,078 | 235 | |||||||||||||
| RESEARCH AND DEVELOPMENT | ||||||||||||||||
| EXPENSES, NET | (25,021 | ) | (13,684 | ) | (13,323 | ) | (7,241 | ) | ||||||||
| SELLING, GENERAL AND | ||||||||||||||||
| ADMINISTRATIVE EXPENSES (2) | (4,298 | ) | (4,656 | ) | (2,068 | ) | (2,158 | ) | ||||||||
| OPERATING LOSS | (11,373 | ) | (11,895 | ) | (5,839 | ) | (6,744 | ) | ||||||||
| FINANCIAL EXPENSES | (3,827 | ) | (4,013 | ) | (1,907 | ) | (1,793 | ) | ||||||||
| FINANCIAL INCOME | 193 | 207 | 3 | 75 | ||||||||||||
| FINANCIAL EXPENSES, NET | (3,634 | ) | (3,806 | ) | (1,904 | ) | (1,718 | ) | ||||||||
| NET LOSS FOR THE PERIOD | $ | (15,007 | ) | $ | (15,701 | ) | $ | (7,743 | ) | $ | (8,462 | ) | ||||
| NET LOSS PER SHARE OF COMMON | ||||||||||||||||
| STOCK-BASIC AND DILUTED | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.05 | ) | $ | (0.06 | ) | ||||
| WEIGHTED AVERAGE NUMBER OF | ||||||||||||||||
| SHARES OF COMMON STOCK | ||||||||||||||||
| USED IN COMPUTING LOSS | ||||||||||||||||
| PER SHARE - BASIC AND DILUTED | 148,382,299 | 145,985,445 | 148,382,299 | 146,644,450 | ||||||||||||
| (1) Includes share-based compensation | $ | 316 | $ | 40 | $ | 138 | $ | (2 | ) | |||||||
| (2) Includes share-based compensation | $ | 87 | $ | 34 | $ | (25 | ) | $ | 14 |