Full Press Release Details
Protalix BioTherapeutics Reports Third
Quarter 2015 Financial Results
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
CARMIEL, Israel, November 9, 2015 -- 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
- 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
- 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 Hepatits (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
- 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 . 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
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 Funda o 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.
The Trout Group, LLC
Source: Protalix BioTherapeutics, Inc.
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| 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 |