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Protalix BioTherapeutics Reports Third Quarter 2019 Results and Provides Corporate Update

Key Takeaway: Protalix BioTherapeutics Reports Third Quarter 2019 Results and Provides Corporate Update CARMIEL, Israel, November 7, 2019 -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercializati

Full Press Release Details

Protalix BioTherapeutics Reports Third
Quarter 2019 Results
and Provides Corporate Update
CARMIEL, Israel, November 7, 2019 -- Protalix
BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization
of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system,
today announced its third quarter 2019 financial results and provided a corporate update.
"This has been a consequential
quarter for Protalix during which we continued to make solid progress on our goals to move our Fabry program toward commercialization
and to pursue strategic partnerships and alliances, and we commenced efforts to improve our capital structure," said Dror
Bashan, Protalix's President and Chief Executive Officer. "During the third quarter, we completed enrollment in our
pivotal, head-to-head BALANCE study evaluating PRX-102 compared to Fabrazyme . We also recently reported positive
12-month interim data from our switch-over Phase III BRIDGE study comparing PRX-102 to another standard-of-care treatment,
"With three, now fully enrolled
Phase III clinical trials of PRX-102, we have a robust and thorough clinical program for the treatment of Fabry disease,"
concluded Mr. Bashan. "Our management, scientific and clinical teams are all fully committed to bringing this important treatment
to the Fabry patient community."
Third Quarter 2019 and Recent Clinical
and Corporate Highlights
Financial Results for the Nine Months Ended September 30,
- A reverse stock split at a ratio of not less than
1-for-10 and not greater than 1-for-20, with the exact ratio to be set within that range at the discretion of the Board of Directors
before the day prior to the Special Meeting of Stockholders without further approval or authorization of the stockholders; and
to reduce the total number of shares of the Company's common stock that the Company is authorized to issue from 350 million
to 120 million shares.
Conference Call and Webcast Information
The Company will host a conference call on Thursday, November
7, 2019, at 8:30 am, Eastern Standard Time, 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:
Domestic (USA): 888-224-1005
International: 323-994-2093
Conference ID: 1931108
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
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 was the first company to gain U.S. Food and Drug Administration (FDA)
approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system
represents a new method for developing recombinant proteins in an industrial-scale manner. Our pipeline consists of proprietary,
potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets.
Protalix's first product manufactured
by ProCellEx, taliglucerase alfa, was approved for marketing by the 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, in phase III clinical trials (BALANCE, BRIDGE and BRIGHT studies); and OPRX-106, an orally
delivered anti-inflammatory treatment, and alidornase alfa, both in phase II clinical trials. 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: risks related to our ability to identify
and complete strategic alternatives on attractive terms or at all within the time period required to regain compliance with the
continued listing standards of the NYSE American; risks related to our ability to continue as a going concern absent a refinancing
or restructuring; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance
future research and development, general and administrative expenses and working capital activities; 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; and inability or unwillingness of medical investigators and institutional
review boards to follow our clinical protocols; the risk that the results of the clinical trials of our product candidates will
not support our claims of 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 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 the amount of our future revenues 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; 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.
Chuck Padala, Managing Director
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
September 30, 2019 (Unaudited) December 31, 2018
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 21,442 $ 37,808
Accounts receivable - Trade 8,716 4,729
Other assets 2,756 1,877
Inventories 7,525 8,569
Total current assets $ 40,439 $ 52,983
NON-CURRENT ASSETS:
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT $ 1,953 $ 1,758
PROPERTY AND EQUIPMENT, NET 5,573 6,390
OPERATING LEASE RIGHT OF USE ASSETS 5,764 -
Total assets $ 53,729 $ 61,131
LIABILITIES NET OF CAPITAL DEFICIENCY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade $ 7,755 $ 5,211
Other 12,730 10,274
Operating lease liabilities 1,222 -
Contracts liability 11,612 9,868
Total current liabilities $ 33,319 $ 25,353
LONG TERM LIABILITIES:
Convertible notes $ 50,163 $ 47,966
Contracts liability 28,586 33,027
Liability for employee rights upon retirement 2,606 2,374
Operating lease liabilities 4,532 -
Other long term liabilities 5,372 5,292
Total long term liabilities $ 91,259 $ 88,659
Total liabilities $ 124,578 $ 114,012
COMMITMENTS
CAPITAL DEFICIENCY $ (70,849 ) $ (52,881 )
Total liabilities net of capital deficiency $ 53,729 $ 61,131
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Last updated: Nov 7, 2019