Cystic Fibrosis Foundation Approves Letter of Application Enabling Protalix to Apply for Grant Funding
Debt Refinancing and Financing Significantly improves Financial Position
CARMIEL, Israel, Aug. 09, 2017 (GLOBE NEWSWIRE) -- 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 six months ended June 30, 2017 and provided a corporate update.
"Substantial progress was made across all three of our clinical assets in the second quarter, including active enrollment in all Fabry trials, nearing the end of enrollment for our PRX-106 trial and progress with our interactions with the CF Foundation,” said Moshe Manor, Protalix’s President and Chief Executive Officer. “Recently, we executed a $10 million debt financing to counter balance a similar amount of cash paid out to settle conversions of our 7.50% convertible notes. In addition, we refinanced $9 million principal amount of our 4.50% convertible notes due September 2018 into $8.55 million of new 4.50% convertible notes due February 2022. These transactions solidify our cash position into 2019.”
2017 First Half and Recent Clinical and Corporate Highlights
General Corporate Highlight
Pegunigalsidase alfa (PRX-102) for Fabry Disease
Alidornase alfa (PRX-110) for Cystic Fibrosis
Oral anti-TNF (OPRX-106) for Ulcerative Colitis
Alfataliglicerase for Gaucher Disease
Financial Results for Six Months ended June 30, 2017
Conference Call and Webcast Information
The Company will host a conference call on Wednesday, August 9, 2017, 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 64212629.
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.
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: 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 our ability to enter into transactions regarding the matters discussed herein; 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; 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 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.
PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) (Unaudited) | |||||||||
June 30, 2017 | December 31, 2016 | ||||||||
ASSETS | |||||||||
CURRENT ASSETS: | |||||||||
Cash and cash equivalents | $ | 34,533 | $ | 63,281 | |||||
Accounts receivable – Trade | 3,005 | 693 | |||||||
Other assets | 4,081 | 2,321 | |||||||
Inventories | 7,059 | 5,245 | |||||||
Assets of discontinued operation | 213 | 327 | |||||||
Total current assets | $ | 48,891 | $ | 71,867 | |||||
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,951 | 1,677 | |||||||
PROPERTY AND EQUIPMENT, NET | 8,158 | 8,703 | |||||||
Total assets | $ | 59,000 | $ | 82,247 | |||||
LIABILITIES NET OF CAPITAL DEFICIENCY | |||||||||
CURRENT LIABILITIES: | |||||||||
Accounts payable and accruals: | |||||||||
Trade | $ | 7,852 | $ | 4,007 | |||||
Other | 9,339 | 7,496 | |||||||
Convertible notes | 53,872 | ||||||||
Deferred revenues | 1,925 | 837 | |||||||
Total current liabilities | $ | 19,116 | $ | 66,212 | |||||
LONG TERM LIABILITIES: | |||||||||
Convertible notes | 53,580 | 19,343 | |||||||
Liability for employee rights upon retirement | 2,671 | 2,348 | |||||||
Promissory note | 4,301 | 4,301 | |||||||
Total long term liabilities | $ | 60,552 | $ | 25,992 | |||||
Total liabilities | $ | 79,668 | $ | 92,204 | |||||
COMMITMENTS | |||||||||
CAPITAL DEFICIENCY | (20,668 | ) | (9,957 | ) | |||||
Total liabilities net of capital deficiency | $ | 59,000 | $ | 82,247 |
PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited) | |||||||||||||||
Six Months Ended | Three Months Ended | ||||||||||||||
June 30, 2017 | June 30, 2016 | June 30, 2017 | June 30, 2016 | ||||||||||||
REVENUES | $ | 9,247 | $ | 2,448 | $ | 6,358 | $ | 1,769 | |||||||
COST OF REVENUES | (7,611 | ) | (2,198 | ) | (5,523 | ) | (1,675 | ) | |||||||
GROSS PROFIT | 1,636 | 250 | 835 | 94 | |||||||||||
RESEARCH AND DEVELOPMENT EXPENSES (1) | (15,271 | ) | (17,347 | ) | (9,304 | ) | (10,013 | ) | |||||||
Less – grants | 1,816 | 3,503 | 478 | 2,194 | |||||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET | (13,455 | ) | (13,844 | ) | (8,826 | ) | (7,819 | ) | |||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) | (5,351 | ) | (4,201 | ) | (2,814 | ) | (2,206 | ) | |||||||
OPERATING LOSS | (17,170 | ) | (17,795 | ) | (10,805 | ) | (9,931 | ) | |||||||
FINANCIAL EXPENSES | (5,132 | ) | (1,805 | ) | (3,045 | ) | (901 | ) | |||||||
FINANCIAL INCOME | 1,665 | 338 | 40 | 96 | |||||||||||
(LOSS) INCOME FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES EMBEDDED DERIVATIVE | (38,061 | ) | 14,260 | ||||||||||||
FINANCIAL (EXPENSES) INCOME, NET | (41,528 | ) | (1,467 | ) | 11,255 | (805 | ) | ||||||||
(LOSS) INCOME FROM CONTINUING OPERATIONS | (58,698 | ) | (19,262 | ) | 450 | (10,736 | ) | ||||||||
LOSS FROM DISCONTINUED OPERATIONS | - | (189 | ) | - | (117 | ) | |||||||||
NET (LOSS) INCOME FOR THE PERIOD | $ | (58,698 | ) | $ | (19,451 | ) | $ | 450 | $ | (10,853 | ) | ||||
NET (LOSS) EARNINGS PER SHARE OF COMMON STOCK: | |||||||||||||||
BASIC | |||||||||||||||
(Loss) earnings from continuing operations | (0.47 | ) | (0.20 | ) | 0.00 | (0.11 | ) | ||||||||
Earnings from discontinued operations | - | 0.00 | - | 0.00 | |||||||||||
Net (loss) earnings per share of common stock | $ | (0.47 | ) | $ | (0.20 | ) | $ | 0.00 | $ | (0.11 | ) | ||||
DILUTED | |||||||||||||||
Loss from continuing operations | (0.47 | ) | (0.20 | ) | (0.06 | ) | (0.11 | ) | |||||||
Earnings from discontinued operations | - | 0.00 | - | 0.00 | |||||||||||
Net loss per share of common stock | $ | (0.47 | ) | $ | (0.20 | ) | $ | (0.06 | ) | $ | (0.11 | ) | |||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING (LOSS) INCOME PER SHARE | |||||||||||||||
BASIC | 126,000,782 | 99,737,348 | 127,523,706 | 99,758,511 | |||||||||||
DILUTED | 126,000,782 | 99,737,348 | 192,598,389 | 99,758,511 | |||||||||||
(1) Includes share-based compensation | $ | 120 | $ | 366 | $ | 55 | $ | 128 | |||||||
(2) Includes share-based compensation | $ | 96 | $ | 236 | $ | 43 | $ | 99 |