Protalix BioTherapeutics Reports Third Quarter 2015 Financial Results
November 09 2015 - 4:05PM
Net losses narrowed Recent sale of Company's
Share in Collaboration and Equity Issuance to Pfizer Yielding a
Total of $46 Million to Help Aggressively Push all Three Product
Candidates
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today
reported financial results for the third quarter of 2015.
"The past three months have been very exciting for the company
with positive clinical data shown in PRX-102 and PRX-106," said
Moshe Manor, Protalix's President and Chief Executive Officer. "We
continued to advance our pipeline, and selling our share in the
collaboration of ElelysoTM to Pfizer will allow us to continue to
move forward, stronger than before. We look forward to
reporting on our upcoming End of Phase II meeting with the FDA, and
moving closer to creating a better option for the Fabry
community."
Financial Results for the Period Ended September 30,
2015
- Net loss narrowed to $3.8 million, or $0.04 per share, for the
three months ended September 30, 2015, down $4.2 million, or 52%,
from $8.0 million, or $0.09 per share, for the same period in
2014.
- Total revenues for the three months ended September 30, 2015
were $4.3 million compared to $2.4 million in the same period in
2014. The increase resulted primarily from $1.3 million of
UplsyoTM sales in Brazil.
- Revenue from the Company's share of net income from the
collaboration under the Pfizer agreement increased by $234,000, to
$1.5 million for the three months ended September 30, 2015,
compared to $1.3 million for the same period in 2014.
- Cost of revenues was $6.8 million for the nine months ended
September 30, 2015 compared to $7.5 million for the same period in
2014.
- Selling, general and administrative expenses decreased 14% to
$6.3 million for the nine months ended September 30, 2015 compared
to $7.3 million for nine months ended September 30, 2014.
- Cash and cash equivalents as of September 30, 2015 were $34.2
million representing an average quarterly cash consumption of
approximately $6.7 million, a $1.9 million decrease compared to the
same period in 2014. The cash balance does not include the
$46.0 million from the sale of our share in collaboration as
detailed below.
Third Quarter and Recent Clinical and Corporate
Highlights
- The Company recently sold its share in collaboration for
Elelyso for $36.0 million and issued approximately 6% of its
outstanding shares to Pfizer for additional $10.0 million. The
pro forma cash balance of approximately $80.0 million as of
September 30, 2015, after giving effect to the transaction allows
us to aggressively push our clinical pipeline forward and
concentrate on our new strategy of developing superior
biologics.
- Results from the 12 month study of the 0.2mg, lowest dose of
PRX-102 in Fabry patients showed significant improvement across
multiple parameters. Most importantly, the clinical data on
Kidney Function was promising with reversal of the eGFR slope.
The low incidence of antibody formation leads to full active
dose availability for effective treatment.
- Interim clinical data of the 1mg dose of PRX-102 in Fabry
patients demonstrated significant improvement across all disease
parameters coupled with an excellent safety profile. Only one
patient experienced hypersensitivity, and approximately 19% of the
patients developed antibodies. Additionally, PRX-102
demonstrated a reduction in renal peritubular capillary Gb3 of
86%.
- The Company expects to report on its End of Phase II meeting
with the FDA before the end of the year and provide additional
guidance on its plans regarding its plans for a pivotal phase III
clinical trial of PRX-102 to support drug approval.
- The Company is currently producing Fabry drug substance for its
planned phase III trial as part of the process of converting its
current approved manufacturing facility to an approved multi
product facility, thereby introducing potentially significant
operational savings.
- The Company is currently planning an Inflammatory Bowel Disease
(IBD) proof of concept study in patients for PRX-106 which the
Company anticipates commencing by the first quarter of 2016.
The Company is also exploring Non Alcoholic Steato Hepatitis
(NASH) as a candidate for PRX-106. In preclinical studies,
PRX-106 alleviated immune-mediated hepatitis and reduced interferon
gamma levels in ConA inflammatory mouse models. Further, the
drug was shown to alleviate liver damage and reduce liver necrosis
and reduce ALT and AST which led to an improvement in liver
biopsies.
- The Company completed a toxicity study in PRX-110 AIR DNaseTM
for the treatment of Cystic Fibrosis. The toxicity study was
designed to support a phase I clinical trial, which is scheduled to
start before the end of the year, to be followed by a proof of
concept study in Cystic Fibrosis patients during the first half of
2016.
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(R). 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: PRX-102, a modified version of the recombinant
human alpha-GAL-A protein for the treatment of Fabry disease;
PRX-112, an orally-delivered glucocerebrosidase enzyme that is
produced and encapsulated within carrot cells, for the treatment of
Gaucher disease; PRX-106, an orally-delivered anti-inflammatory
treatment; PRX-110 for the treatment of Cystic Fibrosis; and
others.
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
"anticipate," "believe," "estimate," "expect," "plan" 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: 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
commercialization efforts for taliglucerase alfa in Brazil; 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 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; 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; 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 release are valid
only as of the date hereof and we disclaim any obligation to update
this information.
PROTALIX
BIOTHERAPEUTICS, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(U.S. dollars in
thousands) |
(Unaudited) |
|
|
September 30,
2015 |
December 31,
2014 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash
equivalents |
$ 34,248 |
$ 54,767 |
|
Accounts receivable -
Trade |
4,573 |
1,884 |
|
Other assets |
2,716 |
2,202 |
|
Inventories |
6,339 |
6,667 |
|
Total current
assets |
47,876 |
65,520 |
|
|
|
|
|
FUNDS IN RESPECT OF EMPLOYEE RIGHTS
UPON RETIREMENT |
1,569 |
1,555 |
|
PROPERTY AND EQUIPMENT,
NET |
9,957 |
11,282 |
|
DEFERRED CHARGES |
90 |
113 |
|
Total
assets |
$ 59,492 |
$ 78,470 |
|
|
|
|
|
LIABILITIES NET OF CAPITAL
DEFICIENCY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable and
accruals: |
|
|
|
Trade |
$ 4,057 |
$ 3,951 |
|
Other |
11,946 |
15,496 |
|
Deferred revenues |
6,850 |
6,763 |
|
Total current
liabilities |
22,853 |
26,210 |
|
|
|
|
|
LONG TERM LIABILITIES: |
|
|
|
Convertible notes |
67,774 |
67,464 |
|
Deferred revenues |
35,127 |
37,232 |
|
Liability in connection with
collaboration operation |
|
912 |
|
Liability for employee rights
upon retirement |
2,249 |
2,253 |
|
Total long term
liabilities |
105,150 |
107,861 |
|
Total
liabilities |
128,003 |
134,071 |
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
CAPITAL DEFICIENCY |
(68,511) |
(55,601) |
|
Total liabilities net of
capital deficiency |
$ 59,492 |
$ 78,470 |
|
|
PROTALIX
BIOTHERAPEUTICS, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(U.S. dollars in thousands,
except share and per share data) |
(Unaudited) |
|
|
Nine Months
Ended |
Three Months
Ended |
|
September 30,
2015 |
September 30,
2014 |
September 30,
2015 |
September 30,
2014 |
REVENUES |
$ 12,475 |
$ 11,517 |
$ 4,301 |
$ 2,396 |
COMPANY'S SHARE IN COLLABORATION
AGREEMENT |
3,084 |
2,259 |
1,545 |
1,311 |
COST OF REVENUES |
(6,785) |
(7,476) |
(2,346) |
(1,798) |
GROSS PROFIT |
8,774 |
6,300 |
3,500 |
1,909 |
RESEARCH AND DEVELOPMENT EXPENSES
(1) |
(18,493) |
(23,280) |
(5,260) |
(8,052) |
Less –
grants and
reimbursements |
3,856 |
6,146 |
1,207 |
1,947 |
RESEARCH AND DEVELOPMENT EXPENSES,
NET |
(14,637) |
(17,134) |
(4,053) |
(6,105) |
SELLING, GENERAL AND
ADMINISTRATIVE EXPENSES (2) |
(6,259) |
(7,289) |
(2,254) |
(2,012) |
OPERATING LOSS |
(12,122) |
(18,123) |
(2,807) |
(6,208) |
FINANCIAL EXPENSES |
(2,805) |
(3,490) |
(1,030) |
(1,851) |
FINANCIAL INCOME |
64 |
139 |
17 |
49 |
FINANCIAL EXPENSES –
NET |
(2,741) |
(3,351) |
(1,013) |
(1,802) |
NET LOSS
FOR THE PERIOD |
$ (14,863) |
$ (21,474) |
$ (3,820) |
$ (8,010) |
NET LOSS
PER SHARE OF COMMON STOCK -- BASIC AND
DILUTED: |
$ (0.16) |
$ (0.23) |
$ (0.04) |
$ (0.09) |
WEIGHTED AVERAGE NUMBER OF SHARES OF
COMMON STOCK USED IN COMPUTING LOSS PER SHARE – BASIC AND
DILUTED: |
93,599,414 |
92,828,851 |
93,943,772 |
92,971,572 |
(1) Includes
share-based compensation |
667 |
764 |
258 |
173 |
(2) Includes
share-based compensation |
752 |
(81) |
188 |
(67) |
CONTACT: Investor Contact
Alan Lada
The Trout Group, LLC
646-378-2952
alada@troutgroup.com
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