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Protalix BioTherapeutics Reports 2018 First Quarter Results and Provides Corporate Update

Key Takeaway: Protalix BioTherapeutics Reports 2018 First Quarter Results and Provides Corporate Update CARMIEL, Israel, May 9, 2018 -- GlobeNewswire /Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization o

Full Press Release Details

Protalix BioTherapeutics Reports 2018
First Quarter Results and Provides Corporate Update
CARMIEL, Israel, May 9, 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 three months ended March 31, 2018 and provided a corporate update.
"We continue to execute against our upcoming milestones,
including the completion of enrollment in our phase III clinical trials of PRX-102 and exploring potential partnering opportunities
for our clinical assets," said Moshe Manor, Protalix's President and Chief Executive Officer. "We reported positive
results for OPRX-106 in the first quarter of this year, which not only demonstrate the drug's potential in the treatment
of ulcerative colitis, but also highlight the potential of our ProCellEx platform technology to deliver biologics orally."
2018 First Quarter and Recent Clinical Highlights
Financial Results for Three Months ended March 31, 2018
Conference Call and Webcast Information
The Company will host a conference
call on Wednesday, May 9, 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 8190507.
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 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.
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. 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
March 31, 2018 December 31, 2017
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 41,319 $ 51,163
Accounts receivable - Trade 4,756 1,721
Other assets 2,594 1,934
Inventories 7,019 7,833
Total current assets $ 55,688 $ 62,651
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT 1,798 1,887
PROPERTY AND EQUIPMENT, NET 7,311 7,676
Total assets $ 64,797 $ 72,214
LIABILITIES NET OF CAPITAL DEFICIENCY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade $ 4,872 $ 7,521
Other 10,697 9,310
Convertible notes 5,930 5,921
Total current liabilities $ 21,499 $ 22,752
LONG TERM LIABILITIES:
Convertible notes 46,108 46,267
Deferred revenues 29,030 26,851
Liability for employee rights upon retirement 2,427 2,586
Other long term liabilities 5,172 5,051
Total long term liabilities $ 82,737 $ 80,755
Total liabilities $ 104,236 $ 103,507
COMMITMENTS
CAPITAL DEFICIENCY (39,439 ) (31,293 )
Total liabilities net of capital deficiency $ 64,797 $ 72,214
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Three Months Ended
March 31, 2018 March 31, 2017
REVENUES $ 4,553 $ 2,889
COST OF REVENUES (2,924 ) (2,088 )
GROSS PROFIT 1,629 801
RESEARCH AND DEVELOPMENT EXPENSES (1) (7,286 ) (5,967 )
Less - grants 843 1,338
RESEARCH AND DEVELOPMENT EXPENSES, NET (6,443 ) (4,629 )
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) (2,498 ) (2,537 )
OPERATING LOSS (7,312 ) (6,365 )
FINANCIAL EXPENSES (2,220 ) (2,087 )
FINANCIAL INCOME 132 1,625
LOSS FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES embedded derivative (52,321 )
FINANCIAL (EXPENSES) INCOME, NET (2,088 ) (52,783 )
LOSS FOR THE PERIOD (9,400 ) (59,148 )
NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED $ (0.06 ) $ (0.48 )
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND DILUTED 145,305,982 124,467,602
(1) Includes share-based compensation 42 65
(2) Includes share-based compensation 20 53
Last updated: May 9, 2018