Full Press Release Details
Protalix BioTherapeutics Reports 2017
Full Year Results and Provides Corporate Update
all Fabry Trials is ongoing in over Forty Active Sites
is Projected to Fund the Company through Clinical Trial Read-Outs and into 2020
CARMIEL, Israel, March 6, 2018 - GlobeNewswire
/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, 2017 and provided a
"This has been an exciting year with a great partnership
deal and good progress in all of our clinical programs," said Moshe Manor, Protalix's President and Chief Executive
Officer. "Looking ahead to 2018, we expect to generate and release more data regarding our clinical trials, and to continue
the progress of our programs, both with potential partners and with our current partner, Chiesi Farmaceutici."
2017 and Recent Clinical and Corporate Highlights
Pegunigalsidase (PRX-102) for Fabry Disease
Alidornase (PRX-110) for Cystic Fibrosis
Oral antiTNF (OPRX-106) for Ulcerative Colitis
Alfataliglicerase for Gaucher Disease
Full-Year 2017 Financial Results
Conference Call and Webcast Information
The Company will host a conference
call on Tuesday, March 6, 2018, 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. Protalix has entered into an ex-United States partnership with Chiesi Farmaceutici
S.p.A. for the development and commercialization of pegunigalsidase alfa. Protalix maintains full rights to pegunigalsidase
alfa in the United States.
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: 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 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; risks related to our ability to maintain and manage
our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; 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; 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.
Solebury Trout Group
Source: Protalix BioTherapeutics,
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share amounts)
| December 31, | ||||||||
| 2016 | 2017 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 63,281 | $ | 51,163 | ||||
| Accounts receivable - Trade | 693 | 1,721 | ||||||
| Other assets | 2,648 | 1,934 | ||||||
| Inventories | 5,245 | 7,833 | ||||||
| Total current assets | 71,867 | 62,651 | ||||||
| FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,677 | 1,887 | ||||||
| PROPERTY AND EQUIPMENT, NET | 8,703 | 7,676 | ||||||
| Total assets | $ | 82,247 | $ | 72,214 | ||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 4,007 | $ | 7,521 | ||||
| Other | 7,496 | 9,310 | ||||||
| Convertible notes | 53,872 | 5,921 | ||||||
| Deferred revenues | 837 | |||||||
| Total current liabilities | 66,212 | 22,752 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 19,343 | 46,267 | ||||||
| Deferred revenues | 26,851 | |||||||
| Liability for employee rights upon retirement | 2,348 | 2,586 | ||||||
| Other long term liabilities | 4,301 | 5,051 | ||||||
| Total long term liabilities | 25,992 | 80,755 | ||||||
| Total liabilities | 92,204 | 103,507 | ||||||
| COMMITMENTS (Note 6) | ||||||||
| CAPITAL DEFICIENCY: | ||||||||
| Common Stock, $0.001 par value: Authorized - as of December 31, 2016 and 2017, 250,000,000 shares; issued and outstanding, respectively - as of December 31, 2016 and 2017, 124,134,085 shares and 143,728,797 shares, respectively | 124 | 144 | ||||||
| Additional paid-in capital | 202,575 | 266,495 | ||||||
| Accumulated deficit | (212,656 | ) | (297,932 | ) | ||||
| Total capital deficiency | (9,957 | ) | (31,293 | ) | ||||
| Total liabilities net of capital deficiency | $ | 82,247 | $ | 72,214 |
PROTALIX BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share amounts)
| Year ended December 31, | ||||||||||||
| 2015 | 2016 | 2017 | ||||||||||
| REVENUES | $ | 4,364 | $ | 9,199 | $ | 19,242 | ||||||
| COST OF REVENUES | (730 | ) | (8,398 | ) | (15,231 | ) | ||||||
| GROSS PROFIT | 3,634 | 801 | 4,011 | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES | (24,889 | ) | (30,412 | ) | (32,170 | ) | ||||||
| Less - grants | 4,864 | 5,804 | 3,336 | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (20,025 | ) | (24,608 | ) | (28,834 | ) | ||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (7,279 | ) | (9,356 | ) | (11,530 | ) | ||||||
| OPERATING LOSS | (23,670 | ) | (33,163 | ) | (36,353 | ) | ||||||
| FINANCIAL EXPENSES | (3,735 | ) | (4,192 | ) | (9,725 | ) | ||||||
| FINANCIAL INCOME | 123 | 589 | 188 | |||||||||
| 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 | (3,612 | ) | 3,987 | (48,923 | ) | |||||||
| LOSS FROM CONTINUING OPERATIONS | (27,282 | ) | (29,176 | ) | (85,276 | ) | ||||||
| (LOSS) INCOME FROM DISCONTINUED OPERATIONS | 85,319 | (189 | ) | |||||||||
| NET (LOSS) INCOME FOR THE YEAR | $ | 58,037 | $ | (29,365 | ) | $ | (85,276 | ) | ||||
| NET (LOSS) INCOME PER SHARE OF COMMON STOCK - BASIC AND DILUTED | ||||||||||||
| Loss from continuing operations | $ | (0.29 | ) | $ | (0.29 | ) | $ | (0.65 | ) | |||
| Income from discontinued operations | 0.90 | (0.00 | ) | |||||||||
| Net (loss) income per share of common stock | $ | 0.61 | $ | (0.29 | ) | $ | (0.65 | ) | ||||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE OF COMMON STOCK, BASIC AND DILUTED | 94,922,390 | 101,387,704 | 131,085,958 |