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Protalix BioTherapeutics Reports First Quarter 2020 Financial Results and Business Update Conference call and live webcast scheduled for Monday, June 1 st , 2020 at 8:30 am

Key Takeaway: Protalix BioTherapeutics Reports First Financial Results and Business Update Conference call and live webcast scheduled for Monday, June 1st, 2020 at 8:30 am EDT CARMIEL, Israel, June 1, 2020 /PRNewswire/Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopha

Full Press Release Details

Protalix BioTherapeutics Reports First
Financial Results and Business Update
Conference call and live webcast scheduled
for Monday, June 1st, 2020 at 8:30 am EDT
CARMIEL, Israel, June 1, 2020 /PRNewswire/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 reported financial results for the first quarter ended March 31, 2020, and provided a business update on recent corporate
and clinical developments. The Company's management will discuss the financial results and provide a clinical, corporate
and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight
"The first quarter of 2020 has most certainly been transformational
for Protalix, despite the COVID-19 pandemic that affected the global markets," said Dror Bashan, Protalix's President
and Chief Executive Officer. "I am proud to say that despite the pandemic, Protalix was able to keep the company running
smoothly and adapt quickly to the changing environment."
"During the quarter, we were able to close a $43.7 million
private placement," he continued. "Furthermore, the topline results from the completion of our Phase III BRIDGE study
and the subsequent BLA submission for PRX-102 announced in May prove that Protalix has actually gained momentum by leaning into
this unprecedented challenge. I am convinced now more than ever that our team is positioned for long-term success and look forward
to continuing our momentum through the rest of this year and into 2021."
Conference Call and Webcast Information
The Company will host a conference call on Monday, June 1,
2020, at 8:30 am, Eastern Daylight 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: 877-423-9813
International: 201-689-8573
Conference ID: 13704328
Webcast: https://tinyurl.com/yc32s9jn
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
First Quarter 2020 and Recent Business Highlights
Clinical and Regulatory Advancements
Corporate & Financial Developments
For the three months ended March 31, 2020, compared
to the three months ended March 31, 2019
About Protalix 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 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.
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 consists of proprietary
versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates:
pegunigalsidase alfa, a modified version of the recombinant human -Galactosidase-A protein for the proposed 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: 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 and, if
approved, whether PRX-102 will be commercially successful; 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; and inability or unwillingness of medical investigators and
institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID-19)
outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we
may effect in the public or private equity markets to raise capital to finance future research and development activities, general
and administrative expenses and working capital; 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 amount and sufficiency of our
cash and cash equivalents; risks related to the ultimate purchase by Funda o Oswaldo Cruz of BioManguinhos 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 BioManguinhos
alfataliglicerase generally; risks related to our commercialization efforts for BioManguinhos 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; the risk
that despite the FDA's grant of fast track designation for PRX-102, 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.
Chuck Padala, Managing Director
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
March 31, 2020 December 31, 2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 14,166 $ 17,792
Short-term bank deposits 22,509 -
Accounts receivable - Trade 8,876 4,700
Other assets 2,728 1,832
Inventories 9,488 8,155
Total current assets $ 57,767 $ 32,479
NON-CURRENT ASSETS:
Long-term bank deposits $ 12,505 -
Funds in respect of employee rights upon retirement 1,879 $ 1,963
Property and equipment, net 5,012 5,273
Operating lease right of use assets 5,713 5,677
Total non-current assets $ 25,109 $ 12,913
Total assets $ 82,876 $ 45,392
LIABILITIES NET OF CAPITAL DEFICIENCY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade $ 9,430 $ 6,495
Other 13,757 11,905
Operating lease liabilities 1,126 1,139
Contracts liability 19,014 16,335
Promissory Note 4,301 4,301
Total current liabilities $ 47,628 $ 40,175
LONG TERM LIABILITIES:
Convertible notes $ 51,777 $ 50,957
Contracts liability 7,130 16,980
Liability for employee rights upon retirement 2,531 2,565
Operating lease liabilities 4,481 4,528
Other long term liabilities 210 509
Total long term liabilities $ 66,129 $ 75,539
Total liabilities $ 113,757 $ 115,714
COMMITMENTS
CAPITAL DEFICIENCY (30,881 ) (70,322 )
Total liabilities net of capital deficiency $ 82,876 $ 45,392
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
Last updated: Jun 1, 2020