Protalix BioTherapeutics Reports 2018 First Quarter Results and Provides Corporate Update
May 09 2018 - 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, 2018 and provided a corporate update.
"We continue to execute against our upcoming milestones,
including the completion of enrollment in our phase III clinical
trials of PRX-102 and exploring potential partnering opportunities
for our clinical assets,” said Moshe Manor, Protalix’s President
and Chief Executive Officer. “We reported positive results
for OPRX-106 in the first quarter of this year, which not only
demonstrate the drug’s potential in the treatment of ulcerative
colitis, but also highlight the potential of our ProCellEx platform
technology to deliver biologics orally.”
2018 First Quarter and Recent Clinical
Highlights
- Continued enrollment in the three Phase III trials, the
BALANCE, BRIDGE and BRIGHT studies, for pegunigalsidase alfa
(PRX-102) for the treatment of Fabry disease at nearly 50 clinical
trial sites worldwide.
- Testing of blood samples from certain patients screened for the
BALANCE study were analyzed for anti-drug antibody (ADA) presence
and neutralizing activity, and the cross-reactivity and inhibition
of such antibodies to PRX-102. A description of the data from
the analysis has been accepted as a poster presentation scheduled
on May 25, 2018 at the 55th ERA-EDTA Congress (European Renal
Association – European Dialysis and Transplant Association) being
held in Copenhagen, Denmark, May 24-27, 2018.
- Reported positive top-line clinical results for the Company’s
OPRX-106 phase IIa clinical trial in ulcerative colitis
patients.
- Oral presentation detailing the results from the Company’s
phase IIa clinical trial of OPRX-106 for the treatment of
ulcerative colitis accepted for the Digestive Disease Week® (DDW)
2018 Annual Meeting in Washington, D.C., June 2-5, 2018.
- The presentation at the DDW will include new clinical data and
detailed per patient results further supporting the consistent
effect in patients.
Financial Results for Three Months ended March 31,
2018
- The Company reported a net loss of $9.4 million, or $0.06
per share, basic and diluted for the three-month period ended
March 31, 2018 compared to a net loss of $8.4 million, or
$0.07 per share, basic and diluted, excluding a one-time, non-cash
charge of $52.3 million in connection with the remeasurement
of a derivative, for the three-month period ended March 31,
2017.
- The Company recorded total revenues of $4.6 million for
the three-month period ended March 31, 2018, compared to
$2.9 million for the same period of 2017. The increase
is attributed mainly to increased sales of alfataliglicerase in
Brazil.
- Research and development expenses were $7.3 million for
the three-month period ended March 31, 2018, compared to
$6.0 million for the same period of 2017. The increase
is mainly due to the advanced stages of the Company’s clinical
trials of its drug candidates.
- Selling, general and administrative expenses were
$2.5 million for the three-month period ended March 31,
2018 and March 31, 2017.
- As of March 31, 2018, the Company had $41.3 million
of cash and cash equivalents.
Conference Call and Webcast Information
The Company will host a conference call on Wednesday, May
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 8190507.
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 entered into an ex-United States
partnership with Chiesi Farmaceutici S.p.A. for the development and
commercialization of pegunigalsidase alfa. Protalix maintains
full rights to pegunigalsidase alfa in the United States.
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. 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 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; risks related to our ability
to maintain and manage our relationship with Chiesi Farmaceutici
and any other collaborator, distributor or partner; 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; 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 NanusSolebury Trout Group646-378-2927
mnanus@troutgroup.com
PROTALIX BIOTHERAPEUTICS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)
(Unaudited)
|
March 31, 2018 |
|
December 31,
2017 |
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
41,319 |
|
|
$ |
51,163 |
|
Accounts
receivable – Trade |
|
4,756 |
|
|
|
1,721 |
|
Other
assets |
|
2,594 |
|
|
|
1,934 |
|
Inventories |
|
7,019 |
|
|
|
7,833 |
|
Total
current assets |
$ |
55,688 |
|
|
$ |
62,651 |
|
|
|
|
|
|
|
|
FUNDS IN
RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT |
|
1,798 |
|
|
|
1,887 |
|
PROPERTY AND
EQUIPMENT, NET |
|
7,311 |
|
|
|
7,676 |
|
Total
assets |
$ |
64,797 |
|
|
$ |
72,214 |
|
|
|
|
|
|
|
|
LIABILITIES NET
OF CAPITAL DEFICIENCY |
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accruals: |
|
|
|
|
|
|
Trade |
$ |
4,872 |
|
|
$ |
7,521 |
|
Other |
|
10,697 |
|
|
|
9,310 |
|
Convertible
notes |
|
5,930 |
|
|
|
5,921 |
|
Total
current liabilities |
$ |
21,499 |
|
|
$ |
22,752 |
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES: |
|
|
|
|
|
|
Convertible notes |
|
46,108 |
|
|
|
46,267 |
|
Deferred
revenues |
|
29,030 |
|
|
|
26,851 |
|
Liability
for employee rights upon retirement |
|
2,427 |
|
|
|
2,586 |
|
Other
long term liabilities |
|
5,172 |
|
|
|
5,051 |
|
Total
long term liabilities |
$ |
82,737 |
|
|
$ |
80,755 |
|
Total
liabilities |
$ |
104,236 |
|
|
$ |
103,507 |
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
CAPITAL
DEFICIENCY |
|
(39,439 |
) |
|
|
(31,293 |
) |
Total
liabilities net of capital deficiency |
$ |
64,797 |
|
|
$ |
72,214 |
|
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (U.S. dollars in thousands, except share and
per share data) (Unaudited)
|
Three Months Ended |
|
|
March 31, 2018 |
|
March 31,
2017 |
REVENUES |
$ |
4,553 |
|
|
$ |
2,889 |
|
COST OF
REVENUES |
|
(2,924 |
) |
|
|
(2,088 |
) |
GROSS
PROFIT |
|
1,629 |
|
|
|
801 |
|
RESEARCH AND
DEVELOPMENT EXPENSES (1) |
|
(7,286 |
) |
|
|
(5,967 |
) |
Less – grants |
|
843 |
|
|
|
1,338 |
|
RESEARCH AND
DEVELOPMENT EXPENSES, NET |
|
(6,443 |
) |
|
|
(4,629 |
) |
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES (2) |
|
(2,498 |
) |
|
|
(2,537 |
) |
OPERATING
LOSS |
|
(7,312 |
) |
|
|
(6,365 |
) |
FINANCIAL
EXPENSES |
|
(2,220 |
) |
|
|
(2,087 |
) |
FINANCIAL
INCOME |
|
132 |
|
|
|
1,625 |
|
LOSS FROM
CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES embedded
derivative |
|
|
|
|
(52,321 |
) |
FINANCIAL
(EXPENSES) INCOME, NET |
|
(2,088 |
) |
|
|
(52,783 |
) |
LOSS FOR THE
PERIOD |
|
(9,400 |
) |
|
|
(59,148 |
) |
NET LOSS PER
SHARE OF COMMON STOCK – BASIC AND DILUTED |
$ |
(0.06 |
) |
|
$ |
(0.48 |
) |
WEIGHTED
AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER
SHARE-BASIC AND DILUTED |
|
145,305,982 |
|
|
|
124,467,602 |
|
(1) Includes share-based compensation |
|
42 |
|
|
|
65 |
|
(2) Includes share-based compensation |
|
20 |
|
|
|
53 |
|
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