Protalix BioTherapeutics Reports 2019 First Quarter Results and Provides Corporate Update
May 06 2019 - 7:00AM
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, 2019 and provided a corporate update.
“In the first three months of 2019, we have
continued to execute on enrollment in our PRX-102 studies and have
worked to prepare ourselves for a potential accelerated approval
path,” said Mr. Moshe Manor, Protalix’s President and Chief
Executive Officer. “In addition, we are encouraged by the
initial pharmacokinetic (PK) data from our BRIGHT study, which were
presented at the 15th Annual WORLDSymposiumTM 2019 in February
2019, that demonstrate the potential for PRX-102 to be infused
once-monthly, compared to the current treatment regimen of every
two weeks.”
First Quarter 2019 and Recent Clinical and
Corporate Highlights
- The Company’s BRIGHT phase III clinical trial of
pegunigalsidase alfa, or PRX-102, for the treatment of Fabry
disease is currently one patient away from completion of
enrollment.
- The Company’s BALANCE phase III clinical trial of
pegunigalsidase alfa for the treatment of Fabry disease is
currently eleven patients away from completion of
enrollment.
- The Company presented results from the BRIGHT Study at the 15th
Annual WORLD Symposium showing that infusion of pegunigalsidase
alfa every 4 weeks results in the presence of continuous active
enzyme throughout the entire infusion interval.
- The Company is scheduled to present three posters during the
6th Update on Fabry Disease international conference being held in
Prague, Czech Republic, on May 26-28, 2019.
- To date, more than 40 patients are being treated in the
Company’s various extension studies after opting to continue
treatment with pegunigalsidase alfa after they completed an initial
study.
- The Company plans to meet with the U.S. Food and Drug
Administration (FDA) for a follow up meeting during the second
quarter of 2019 in connection with the potential accelerated
approval filing path for pegunigalsidase alfa.
First Quarter 2019 Financial Results
- The Company recorded total revenues of $10.4 million
during the three months ended March 31, 2019, compared
to $6.7 million for the same period of 2018. The
increase is primary attributable to the recognition of
$6.9 million of license revenues in the three months ended on
March 31, 2019 compared to the recognition of
$2.2 million in the same period of 2018.
- Research and development expenses for the three months ended
March 31, 2019, were $11.7 million, compared
to $7.3 million for the same period in 2018.
Selling, general and administrative expenses for the three
months ended March 31, 2019 were $2.2 million,
compared to $2.5 million incurred during the same period in
2018.
- Net loss for the three months ended March 31,
2019 was $7.3 million compared to $7.2 million
for the three months ended March 31, 2018.
- On March 31, 2019, the Company had $30.4 million
of cash and cash equivalents, compared to $37.8 million
at March 31, 2018, which is currently projected to fund
operations into mid-2020. As of March 31, 2019, the
Company had outstanding $57.9 million of its 7.50% convertible
promissory notes due November 2021.
Conference Call and Webcast Information
The Company will host a conference call on Monday, May 6,
2019, 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 6169584.
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.
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’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.
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: 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; 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 Fundação 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 Fundação 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 by law.
Investor Contact
Marcy Nanus, Managing Director Solebury Trout 646-378-2927
mnanus@soleburytrout.com
|
|
PROTALIX BIOTHERAPEUTICS, INC. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(U.S. dollars in thousands) |
|
|
|
|
|
|
March 31, 2019(Unaudited) |
|
|
|
December 31, 2018 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
30,363 |
|
|
$ |
37,808 |
|
Accounts
receivable – Trade |
|
|
8,565 |
|
|
|
4,729 |
|
Other
assets |
|
|
1,706 |
|
|
|
1,877 |
|
Inventories |
|
|
6,707 |
|
|
|
8,569 |
|
Total
current assets . |
|
$ |
47,341 |
|
|
$ |
52,983 |
|
|
|
|
|
|
|
|
|
|
FUNDS IN
RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT |
|
$ |
1,801 |
|
|
$ |
1,758 |
|
PROPERTY AND
EQUIPMENT, NET |
|
|
6,058 |
|
|
|
6,390 |
|
OPERATING LEASE
RIGHT OF USE ASSETS |
|
|
5,844 |
|
|
|
- |
|
Total assets |
|
$ |
61,044 |
|
|
$ |
61,131 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES NET
OF CAPITAL DEFICIENCY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
|
|
Accounts
payable and accruals: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
5,870 |
|
|
$ |
5,211 |
|
Other |
|
|
10,480 |
|
|
|
10,274 |
|
Operating lease
liabilities |
|
|
1,257 |
|
|
|
|
|
Contracts
liability |
|
|
9,429 |
|
|
|
9,868 |
|
Total
current liabilities |
|
$ |
27,036 |
|
|
$ |
25,353 |
|
|
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES: |
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
48,670 |
|
|
$ |
47,966 |
|
Contracts
liability |
|
|
32,979 |
|
|
|
33,027 |
|
Liability
for employee rights upon retirement |
|
|
2,426 |
|
|
|
2,374 |
|
Operating
lease liabilities |
|
|
4,498 |
|
|
|
|
|
Other
long term liabilities |
|
|
5,290 |
|
|
|
5,292 |
|
Total
long term liabilities |
|
$ |
93,863 |
|
|
$ |
88,659 |
|
Total
liabilities |
|
$ |
120,899 |
|
|
$ |
114,012 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CAPITAL
DEFICIENCY |
|
|
(59,855 |
) |
|
|
(52,881 |
) |
Total
liabilities net of capital deficiency |
|
$ |
61,044 |
|
|
$ |
61,131 |
|
|
|
|
|
|
|
|
|
|
|
|
PROTALIX BIOTHERAPEUTICS, INC. |
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
(U.S. dollars in thousands, except per share data) |
|
(Unaudited) |
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
March 31, 2019 |
|
|
|
March 31, 2018 |
|
REVENUES FROM
SELLING GOODS |
|
$ |
3,530 |
|
|
$ |
4,553 |
|
REVENUES FROM
LICENSE AND R&D SERVICES |
|
|
6,909 |
|
|
|
2,161 |
|
COST OF GOODS
SOLD |
|
|
(2,045 |
) |
|
|
(2,924 |
) |
RESEARCH AND
DEVELOPMENT EXPENSES (1) |
|
|
(11,701 |
) |
|
|
(7,286 |
) |
Less – grants |
|
|
3 |
|
|
|
843 |
|
RESEARCH AND
DEVELOPMENT EXPENSES, NET |
|
|
(11,698 |
) |
|
|
(6,443 |
) |
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES (2) |
|
|
(2,230 |
) |
|
|
(2,498 |
) |
OPERATING
LOSS |
|
|
(5,534 |
) |
|
|
(5,151 |
) |
FINANCIAL
EXPENSES |
|
|
(1,920 |
) |
|
|
(2,220 |
) |
FINANCIAL
INCOME |
|
|
190 |
|
|
|
132 |
|
FINANCIAL
EXPENSES, NET |
|
|
(1,730 |
) |
|
|
(2,088 |
) |
LOSS FOR THE
PERIOD |
|
$ |
(7,264 |
) |
|
$ |
(7,239 |
) |
NET LOSS PER
SHARE OF COMMON STOCK – |
|
|
|
|
|
|
|
|
BASIC AND
DILUTED |
|
$ |
(0.05 |
) |
|
$ |
(0.05 |
) |
WEIGHTED
AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING
LOSS PER SHARE-BASIC AND DILUTED |
|
|
148,382,299 |
|
|
|
145,305,982 |
|
(1) Includes share-based compensation |
|
$ |
178 |
|
|
$ |
42 |
|
(2) Includes share-based compensation |
|
$ |
112 |
|
|
$ |
20 |
|
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