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Protalix BioTherapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update Announced positive top-line data in its Phase III BRIDGE study of PRX-102 for the Treatment of Fabry disease Submission

Key Takeaway: Protalix BioTherapeutics Reports Second Financial Results and Provides Business Announced positive top-line data in its Phase III BRIDGE study of PRX-102 for the Treatment of Fabry disease Submission of a Biologics License Application (BLA) to the U.S. Food and Drug Adminis

Full Press Release Details

Protalix BioTherapeutics Reports Second
Financial Results and Provides Business
Announced positive top-line data
in its Phase III BRIDGE study of
PRX-102 for the Treatment of Fabry disease
Submission of a Biologics License
Application (BLA) to the U.S. Food and Drug Administration for PRX-102 for the treatment of Fabry disease
Conference call and live webcast scheduled
for Monday, August 10, 2020 at 8:30 am ET
CARMIEL, Israel, August 10, 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 second quarter ended June 30, 2020, and provided a business update on recent corporate
and clinical developments.
"This quarter, we delivered on two very important milestones
for the company: announcing positive topline results in our BRIDGE phase III clinical trial of PRX-102 for the treatment
of Fabry disease and subsequent BLA submission to the U.S. Food and Drug Administration (FDA). We were able to accomplish
these goals even as we faced the challenging headwinds from the global COVID-19 pandemic, and I am very proud of our entire team
for their commitment and dedication," said Dror Bashan, Protalix's President and Chief Executive Officer. "As
we look towards an exciting second half of the year, we are continuing to build Protalix for the long term. We augmented our research
and development team with highly qualified and seasoned veterans to support and enhance our pipeline, and we announced a new partnership
to explore the development of PRX-110." Mr. Bashan concluded, "We are gratified to have a balance sheet supporting
our strategic plans and look forward to continuing to execute as we move towards the anticipated commercial launch of PRX-102 for
the treatment of Fabry disease."
Recent Business Highlights
Second Quarter 2020 Financial Highlights
The Company recorded revenues from selling
goods of $3.6 million during the three months ended June 30, 2020, an increase of $0.2 million, or 6%, compared
to revenues of $3.4 million for the same period of 2019.
Revenues from license and R&D services
for the three months ended June 30, 2020, were $7.3 million, a decrease of $1.5 million, or 17%, compared to revenues
of $8.8 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues
the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion
of two out of the three phase III clinical trials of PRX-102 as well as lower costs related to the Company's phase III BALANCE
clinical trial of PRX-102 for the treatment of Fabry disease.
Cost of goods sold was $1.8 million for
the three months ended June 30, 2020, a decrease of $0.9 million, or 32%, from cost of goods sold of $2.7 million
for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to
the Israeli Innovation Authority.
Research and development expenses were $9.2 million
for the three months ended June 30, 2020, a decrease of $4.1 million, or 31%, compared to $13.3 million of research
and development expenses for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III
clinical trials of PRX-102 and reduced costs related to the Company's phase III BALANCE clinical trial as well as a
decrease in costs related to manufacturing of the Company's drug in development as some of the manufactured drug product
and related costs have been recorded as inventory.
Selling, general and administrative expenses
were $2.2 million for the three months ended June 30, 2020, an increase of $0.1 million, or 6%, compared to $2.1 million
for the same period of 2019.
Cash and cash equivalents at June 30,
2020 was $4.8 million, with $35.2 million in bank deposits.
Conference Call and Webcast Information
The Company will host a conference call on Monday, August 10,
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: 13706783
Webcast: https://tinyurl.com/y3cuc7gw
The conference call will be broadcast live and also 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, 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;
PRX-115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; 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 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
Last updated: Aug 10, 2020