Protalix BioTherapeutics Reports Full Year 2014 Financial Results and Provides Corporate Update
CARMIEL,
Financial Results for the Year Ended
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Total revenues for the full year ended
December 31, 2014 were$13.7 million compared to$10.5 million for the full year endedDecember 31, 2013 . -
Elelyso™ revenues from sales of the product increased 53.6% to
$9.1 million for the full year endedDecember 31, 2014 compared to$5.9 million for the full year endedDecember 31 , 2013. This increase is primarily due to$3.5 million in revenues recorded from sales inBrazil under the supply and technology transfer agreement. -
Protalix's share in the collaboration agreement with Pfizer for the full year ended
December 31, 2014 increased to $1.5 million compared to$1.0 million for the full year endedDecember 31, 2013 , despite last quarter's net loss of approximately$750,000 , mainly due to one-time charges in connection with launch activities in Canada. -
Elelyso worldwide product sales for the full year ended
December 31, 2014 were$25.9 million , an increase of approximately 30%, compared to sales of$20.0 million for the full year endedDecember 31, 2013 . -
Cost of revenues was
$9.1 million for the full year endedDecember 31, 2014 compared to $5.4 million for the full year endedDecember 31 , 2013. Protalix recognized $6.1 million in gross profit for both fiscal years 2014 and 2013. The increase in cost of revenues is mainly attributed to the cost of products sold to Pfizer. -
Selling, general and administrative expenses for the full year ended
December 31, 2014 were $9.7 million compared to$8.4 million for the full year endedDecember 31, 2013 . -
Net loss for the full year 2014 was $29.9 million, or $0.32 per share, compared to
$27.8 million , or $0.30 per share, for the full year 2013. -
Cash and cash equivalents as of December 31, 2014 were $54.8 million.
Corporate Update and Operation Highlights
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In
January 2015 , Protalix announced a new strategy for accelerated growth focused on developing products with potentially clinically superior profiles that offer a clear competitive advantage over other products. -
For PRX-102, interim results from the phase I/II clinical trial of Fabry patients demonstrated positive results across all disease parameters. Completion of enrollment in this trial was announced on
February 2 , 2015. Interim data from the 1mg/kg dose cohort of the trial is expected during the third quarter of 2015, with final results by year end. Protalix expects to launch a phase III pivotal trial, which is planned to be a head-to-head study comparing PRX-102 to a commercially available enzyme replacement therapy for Fabry disease, in early 2016. -
In
February 2015 , the last Gaucher patient was treated in Protalix's phase IIa clinical trial of oral GCD. An initial analysis of the results demonstrates that oral GCD was safe and well tolerated. Active GCD enzyme was detected in the blood circulation of 10 out of the 17 participants in the trial. In addition, elevated platelet levels were observed in 10 out of the 17 participants in the trial. In 2015, Protalix intends to focus its efforts on reformulating oral GCD in order to prepare a viable solution for further clinical development. - Protalix is currently reviewing potential indications for its planned oral antiTNF study. This trial is expected to be launched in the second half of this year, enrolling first healthy volunteers and then patients. Results are expected to be released in early 2016.
- Protalix is also currently evaluating clinical sites for its planned AIR DNase trial, which is expected to first enroll healthy volunteers and then cystic fibrosis patients. The trial is being designed to run as a head-to-head study comparing AIR DNase to Pulmozyme. Protalix expects that this trial will be launched in the second half of this year with results released in early 2016.
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In
the United States , Elelyso is being prescribed to approximately 30% of newly diagnosed patients and to approximately 25% of all switch patients; however, the total number of patient switches is relatively low. -
Protalix reorganized its scientific advisory board establishing a core team consisting of
Roger D. Kornberg , Ph.D., ProfessorAaron Ciechanover , M.D., D.Sc.,Alexander Levitzki , Ph.D. andRichard Lerner , M.D. Dr. Kornberg and Dr. Ciechanover are both laureates of the Nobel Prize in Chemistry.
"We continue to work closely with Pfizer, the Gaucher community and payors to increase ELELYSO™ market share across all territories. While this growth has been slower than anticipated, the number of patients on drug continues to increase steadily year over year," said
About Protalix
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 (
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
PROTALIX BIOTHERAPEUTICS, INC. | ||
CONSOLIDATED BALANCE SHEETS | ||
(U.S. dollars in thousands, except share amounts) | ||
December 31, | ||
2013 | 2014 | |
ASSETS | ||
CURRENT ASSETS: | ||
Cash and cash equivalents | $86,398 | $54,767 |
Accounts receivable- Trade | 2,091 | 1,884 |
Other assets | 1,457 | 2,202 |
Inventories | 7,957 | 6,667 |
Total current assets | 97,903 | 65,520 |
FUNDS IN RESPECT OF EMPLOYEE | ||
RIGHTS UPON RETIREMENT | 1,578 | 1,555 |
PROPERTY AND EQUIPMENT, NET | 13,711 | 11,282 |
DEFERRED CHARGES | 141 | 113 |
Total assets | $113,333 | $78,470 |
LIABILITIES NET OF CAPITAL DEFICIENCY | ||
CURRENT LIABILITIES: | ||
Accounts payable and accruals: | ||
Trade | $5,254 | $3,951 |
Other | 12,073 | 15,496 |
Deferred revenues | 9,369 | 6,763 |
Total current liabilities | 26,696 | 26,210 |
LONG TERM LIABILITIES: | ||
Convertible notes | 67,048 | 67,464 |
Deferred revenues | 41,796 | 37,232 |
Liability in connection with collaboration operation | 2,371 | 912 |
Liability for employee rights upon retirement | 2,368 | 2,253 |
Total long term liabilities | 113,583 | 107,861 |
Total liabilities | 140,279 | 134,071 |
COMMITMENTS | ||
CAPITAL DEFICIENCY: | ||
Common Stock, $0.001 par value: | ||
Authorized - as of December 31, 2013 and 2014, 150,000,000 shares; issued and outstanding - as of December 31, 2013 and 2014, 93,551,098 shares and 93,603,819 shares, respectively | 93 | 94 |
Additional paid-in capital | 184,346 | 185,633 |
Accumulated deficit | (211,385) | (241,328) |
Total capital deficiency | (26,946) | (55,601) |
Total liabilities net of capital deficiency | $113,333 | $78,470 |
PROTALIX BIOTHERAPEUTICS, INC. | ||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||
(U.S. dollars in thousands, except shares and per share amounts) | ||
Year ended December 31, | ||
2013 | 2014 | |
REVENUES | $10,479 | $13,651 |
COMPANY'S SHARE IN COLLABORATION AGREEMENT | 1,034 | 1,509 |
COST OF REVENUES | (5,428) | (9,053) |
GROSS PROFIT | 6,085 | 6,107 |
RESEARCH AND DEVELOPMENT EXPENSES | (33,313) | (29,761) |
Less – grants and reimbursements | 8,497 | 8,111 |
RESEARCH AND DEVELOPMENT EXPENSES, NET | (24,816) | (21,650) |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (8,385) | (9,661) |
OPERATING LOSS | (27,116) | (25,204) |
FINANCIAL EXPENSES | (1,065) | (4,935) |
FINANCIAL INCOME | 391 | 196 |
FINANCIAL INCOME (EXPENSES) – NET | (674) | (4,739) |
NET LOSS FOR THE YEAR | $(27,790) | $(29,943) |
NET LOSS PER SHARE OF COMMON STOCK – BASIC AND DILUTED | $(0.30) | $(0.32) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE OF COMMON STOCK, BASIC AND DILUTED | 92,368,138 | 92,891,846 |
CONTACT: Investor Contact Marcy NanusThe Trout Group, LLC 646-378-2927 mnanus@troutgroup.com