Recent Updates
Recently added Catalysts
PLX

Protalix BioTherapeutics Reports 2018 Second Quarter Results and Provides Corporate Update

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

Full Press Release Details

Protalix BioTherapeutics Reports 2018
Second Quarter Results and Provides Corporate Update
CARMIEL, Israel, August 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 six-month period ended June 30, 2018 and provided a corporate update.
"This has been a fantastic quarter for the company highlighted
by the expansion of our partnership with Chiesi that resulted from the strong relationship developed over the past months,"
commented Moshe Manor, Protalix's President and Chief Executive Officer. "Additionally, we believe that the recent
draft guidelines from the U.S. Food and Drug Administration, or the FDA, released in July regarding enzyme replacement therapies
could significantly benefit the regulatory path forward for PRX-102."
2018 Second Quarter and Recent Clinical Highlights
Financial Results for the Six Months ended June 30, 2018
Conference Call and Webcast Information
The Company will host a conference
call on Thursday, August 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 9488046.
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 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. 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 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
Solebury Trout Group
Source: Protalix BioTherapeutics,
PROTALIX BIOTHERAPEUTICS,
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
June 30, 2018 December 31, 2017
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 28,327 $ 51,163
Accounts receivable - Trade 5,248 1,721
Other assets 2,499 1,934
Inventories 6,978 7,833
Total current assets $ 43,052 $ 62,651
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT 1,729 1,887
PROPERTY AND EQUIPMENT, NET 6,940 7,676
Total assets $ 51,721 $ 72,214
LIABILITIES NET OF CAPITAL DEFICIENCY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade $ 6,001 $ 7,521
Other 9,071 9,310
Convertible notes 5,921
Total current liabilities $ 15,072 $ 22,752
LONG TERM LIABILITIES:
Convertible notes 46,742 46,267
Deferred revenues 31,885 26,851
Liability for employee rights upon retirement 2,335 2,586
Other long term liabilities 5,258 5,051
Total long term liabilities $ 86,220 $ 80,755
Total liabilities $ 101,292 $ 103,507
COMMITMENTS
CAPITAL DEFICIENCY (49,571 ) (31,293 )
Total liabilities net of capital deficiency $ 51,721 $ 72,214
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Six Months Ended Three Months Ended
June 30, 2018 June 30, 2017 June 30, 2018 June 30, 2017
REVENUES $ 6,559 $ 9,247 $ 2,006 $ 6,358
COST OF REVENUES (5,107 ) (7,611 ) (2,183 ) (5,523 )
GROSS PROFIT (LOSS) 1,452 1,636 (177 ) 835
RESEARCH AND DEVELOPMENT EXPENSES (1) (14,762 ) (15,271 ) (7,476 ) (9,304 )
Less - grants 1,078 1,816 235 478
RESEARCH AND DEVELOPMENT EXPENSES, NET (13,684 ) (13,455 ) (7,241 ) (8,826 )
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) (4,656 ) (5,351 ) (2,158 ) (2,814 )
OPERATING LOSS (16,888 ) (17,170 ) (9,576 ) (10,805 )
FINANCIAL EXPENSES (4,013 ) (5,132 ) (1,793 ) (3,045 )
FINANCIAL INCOME 207 1,665 75 40
(LOSS) INCOME FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES EMBEDDED DERIVATIVE (38,061 ) 14,260
FINANCIAL (EXPENSES) INCOME, NET (3,806 ) (41,528 ) (1,718 ) 11,255
NET (LOSS) INCOME FOR THE PERIOD $ (20,694 ) $ (58,698 ) $ (11,294 ) $ 450
NET (LOSS) EARNINGS PER SHARE OF COMMON STOCK :
BASIC
Net (loss) earnings per share of common stock $ (0.14 ) $ (0.47 ) $ (0.08 ) $ 0.00
DILUTED
Net loss per share of common stock $ (0.14 ) $ (0.47 ) $ (0.08 ) $ (0.06 )
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING (LOSS) EARNINGS PER SHARE
BASIC 145,985,445 126,000,782 146,644,450 127,523,706
DILUTED 145,985,445 126,000,782 146,644,450 192,598,389
(1) Includes share-based compensation $ 40 $ 120 $ (2 ) $ 55
(2) Includes share-based compensation $ 34 $ 96 $ 14 $ 43
Last updated: Aug 9, 2018