Full Press Release Details
Protalix BioTherapeutics Reports 2018 Full
Year Results and Provides Corporate Update
CARMIEL, Israel, March 18, 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 full-year ended December 31, 2018 and provided a corporate update.
"Throughout 2018 and into early 2019, we significantly advanced
our clinical development program for PRX-102 and, as of today, have enrolled 127 Fabry disease patients across all of our PRX-102
clinical trials. Most recently, we had a very productive meeting with the U.S. Food and Drug Administration (FDA) to discuss the
potential filing of an application for accelerated approval and, at the FDA's request, we intend to hold a follow up meeting
by the end of the second quarter of 2019 to discuss the data and content of the potential filing for accelerated approval. We are
very pleased with the collaborative manner our engagement with the FDA has been to date and cautiously optimistic about the prospects
of our discussions with the agency," said Mr. Moshe Manor, Protalix's President and Chief Executive Officer. "We
are very excited as we move forward into 2019 which could be a transformational year for us, including the read outs from our Fabry
trials and the potential for establishing the path for accelerated approval for PRX-102 with the FDA."
2018 Clinical and Corporate Highlights
Pegunigalsidase alfa (PRX-102) for the treatment of Fabry Disease
Oral antiTNF (OPRX-106) for Ulcerative Colitis
Alidornase alfa (PRX-110) for the treatment of Cystic Fibrosis
Full-Year 2018 Financial Results
Conference Call and Webcast Information
The Company will host a conference call on Monday, March 18,
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 9583103.
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
About Protalix BioTherapeutics,
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.
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 "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; 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.
Marcy Nanus, Managing Director
Source: Protalix BioTherapeutics, Inc.
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2017 | 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 51,163 | $ | 37,808 | ||||
| Accounts receivable - Trade | 1,721 | 4,729 | ||||||
| Other assets | 1,934 | 1,877 | ||||||
| Inventories | 7,833 | 8,569 | ||||||
| Total current assets | 62,651 | 52,983 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Funds in respect of employee right upon retirement | 1,887 | 1,758 | ||||||
| Property and equipment, net | 7,676 | 6,390 | ||||||
| Total assets | $ | 72,214 | $ | 61,131 | ||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 7,521 | $ | 5,211 | ||||
| Other | 9,310 | 10,274 | ||||||
| Contracts liability | 9,868 | |||||||
| Convertible notes | 5,921 | |||||||
| Total current liabilities | 22,752 | 25,353 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 46,267 | 47,966 | ||||||
| Contracts liability | 25,015 | 33,027 | ||||||
| Liability for employee rights upon retirement | 2,586 | 2,374 | ||||||
| Other long term liabilities | 5,051 | 5,292 | ||||||
| Total long term liabilities | 78,919 | 88,659 | ||||||
| Total liabilities | 101,671 | 114,012 | ||||||
| COMMITMENTS | ||||||||
| CAPITAL DEFICIENCY: | ||||||||
| Common Stock, $0.001 par value: | ||||||||
| Authorized - as of December 31, 2017 and 2018, 250,000,000 shares; issued and outstanding, respectively - as of December 31, 2017 and 2018, 143,728,797 shares and 148,382,299 shares, respectively | 144 | 148 | ||||||
| Additional paid-in capital | 266,495 | 269,524 | ||||||
| Accumulated deficit | (296,096 | ) | (322,553 | ) | ||||
| Total capital deficiency | (29,457 | ) | (52,881 | ) | ||||
| Total liabilities net of capital deficiency | $ | 72,214 | $ | 61,131 |
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share amounts)
| Year ended December 31, | ||||||||||||
| 2016 | 2017 | 2018 | ||||||||||
| REVENUES FROM SELLING GOODS | $ | 9,199 | $ | 19,242 | $ | 8,978 | ||||||
| REVENUES FROM LICENSE AND R&D SERVICES | 1,836 | 25,262 | ||||||||||
| COST OF GOODS SOLD | (8,398 | ) | (15,231 | ) | (9,302 | ) | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES | (30,412 | ) | (32,170 | ) | (35,534 | ) | ||||||
| Less - grants | 5,804 | 3,336 | 2,204 | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (24,608 | ) | (28,834 | ) | (33,330 | ) | ||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (9,356 | ) | (11,530 | ) | (10,916 | ) | ||||||
| OPERATING LOSS | (33,163 | ) | (34,517 | ) | (19,308 | ) | ||||||
| FINANCIAL EXPENSES | (4,192 | ) | (9,725 | ) | (7,685 | ) | ||||||
| FINANCIAL INCOME | 589 | 188 | 536 | |||||||||
| LOSS FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES EMBEDDED DERIVATIVE | (6,473 | ) | (38,061 | ) | ||||||||
| (LOSS) GAIN oN EXTINGUISHMENT OF CONVERTIBLE NOTES | 14,063 | (1,325 | ) | |||||||||
| FINANCIAL (EXPENSES) INCOME - NET | 3,987 | (48,923 | ) | (7,149 | ) | |||||||
| LOSS FROM CONTINUING OPERATIONS | (29,176 | ) | (83,440 | ) | (26,457 | ) | ||||||
| LOSS FROM DISCONTINUED OPERATIONS | (189 | ) | ||||||||||
| NET LOSS FOR THE YEAR | $ | (29,365 | ) | $ | (83,440 | ) | $ | (26,457 | ) | |||
| Net loss per share of common stock - basic and diluted | ||||||||||||
| Loss from continuing operations | $ | (0.29 | ) | $ | (0.64 | ) | $ | (0.18 | ) | |||
| Loss from discontinued operations | (0.00 | ) | ||||||||||
| Net loss per share of common stock | $ | (0.29 | ) | $ | (0.64 | ) | $ | (0.18 | ) | |||
| Weighted average number of shares of common stock used in computing loss per share of common stock, basic and diluted | 101,387,704 | 131,085,958 | 147,135,182 |