Full Press Release Details
Protalix BioTherapeutics Reports 2017
Third Quarter Results and Provides Corporate Update
Agreement with Chiesi Farmaceutici Further Validates Fabry Program and Significantly Improves Financial Position
Resources to Fund Operations into 2020
Further Strengthened by the Reduction of Debt via Conversion of
the Entire $8.55 Million of 2022 Notes
CARMIEL, Israel, November 8, 2017 -- GlobeNewswire /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 nine months ended September 30, 2017 and provided a corporate update.
"I am excited about the progress we made recently," said Moshe Manor, Protalix's President
and Chief Executive Officer. "We are no longer facing any debt issue or financing overhang. Moreover, with the recent strategic
collaboration with Chiesi, not only did we secure a strong, experienced clinical and commercial partner, but we also meaningfully
increased our capital resources, providing us with sufficient cash into 2020, irrespective of any milestone payments we are entitled
to from Chiesi, increased revenues or from future partnerships. In addition, on the strategic front, we now have three novel and
clinically differentiated product candidates in the clinic with potentially superior efficacy which provides us multiple shots
at goal to realize significant value for our stockholders."
Third Quarter and Recent Clinical Highlights
Pegunigalsidase alfa (PRX-102) for Fabry Disease
Alidornase alfa (PRX-110) for Cystic Fibrosis
Oral antiTNF (OPRX-106) for Ulcerative Colitis
Alfataliglicerase for Gaucher Disease
Financial Results for Nine Months ended September 30, 2017
Conference Call and Webcast Information
The Company will host a conference
call on Wednesday, November 8, 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: (844) 358-6760; International: (478) 219-0004. Conference ID number 6767278.
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
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.
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 Funda o 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 Funda o Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology
transfer agreement; risks related to our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other
collaborator, distributor or partner; 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.
The Trout Group, LLC
BioTherapeutics, Inc.
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| September 30, 2017 | December 31, 2016 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 33,482 | $ | 63,281 | ||||
| Accounts receivable - Trade | 7,292 | 693 | ||||||
| Other assets | 2,689 | 2,321 | ||||||
| Inventories | 7,479 | 5,245 | ||||||
| Assets of discontinued operation | 211 | 327 | ||||||
| Total current assets | $ | 51,153 | $ | 71,867 | ||||
| FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,919 | 1,677 | ||||||
| PROPERTY AND EQUIPMENT, NET | 7,986 | 8,703 | ||||||
| Total assets | $ | 61,058 | $ | 82,247 | ||||
| LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 8,691 | $ | 4,007 | ||||
| Other | 11,989 | 7,496 | ||||||
| Convertible notes | 5,911 | 53,872 | ||||||
| Deferred revenues | 837 | |||||||
| Total current liabilities | $ | 26,591 | $ | 66,212 | ||||
| LONG TERM LIABILITIES: | ||||||||
| Convertible notes | 53,625 | 19,343 | ||||||
| Liability for employee rights upon retirement | 2,612 | 2,348 | ||||||
| Promissory note | 4,301 | 4,301 | ||||||
| Total long term liabilities | $ | 60,538 | $ | 25,992 | ||||
| Total liabilities | $ | 87,129 | $ | 92,204 | ||||
| COMMITMENTS | ||||||||
| CAPITAL DEFICIENCY | (26,071 | ) | (9,957 | ) | ||||
| Total liabilities net of capital deficiency | $ | 61,058 | $ | 82,247 |
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share
| Nine Months Ended | Three Months Ended | |||||||||||||||
| September 30, 2017 | September 30, 2016 | September 30, 2017 | September 30, 2016 | |||||||||||||
| REVENUES | $ | 16,773 | $ | 7,118 | $ | 7,526 | $ | 4,670 | ||||||||
| COST OF REVENUES | (13,677 | ) | (6,446 | ) | (6,066 | ) | (4,248 | ) | ||||||||
| GROSS PROFIT | 3,096 | 672 | 1,460 | 422 | ||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES (1) | (22,389 | ) | (23,700 | ) | (7,118 | ) | (6,353 | ) | ||||||||
| Less - grants | 2,545 | 4,800 | 729 | 1,297 | ||||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, NET | (19,844 | ) | (18,900 | ) | (6,389 | ) | (5,056 | ) | ||||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) | (8,187 | ) | (6,215 | ) | (2,836 | ) | (2,014 | ) | ||||||||
| OPERATING LOSS | (24,935 | ) | (24,443 | ) | (7,765 | ) | (6,648 | ) | ||||||||
| FINANCIAL EXPENSES | (8,809 | ) | (2,715 | ) | (3,680 | ) | (910 | ) | ||||||||
| FINANCIAL INCOME | 1,670 | 606 | 8 | 268 | ||||||||||||
| LOSS FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES EMBEDDED DERIVATIVE | (38,061 | ) | ||||||||||||||
| FINANCIAL EXPENSES, NET | (45,200 | ) | (2,109 | ) | (3,672 | ) | (642 | ) | ||||||||
| LOSS FROM CONTINUING OPERATIONS | (70,135 | ) | (26,552 | ) | (11,437 | ) | (7,290 | ) | ||||||||
| LOSS FROM DISCONTINUED OPERATIONS | - | (189 | ) | - | - | |||||||||||
| NET LOSS FOR THE PERIOD | $ | (70,135 | ) | $ | (26,741 | ) | $ | (11,437 | ) | $ | (7,290 | ) | ||||
| NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED | ||||||||||||||||
| Loss from continuing operations | (0.55 | ) | (0.27 | ) | (0.09 | ) | (0.07 | ) | ||||||||
| Loss from discontinued operations | (0.00 | ) | ||||||||||||||
| Net loss per share of common stock | $ | (0.55 | ) | $ | (0.27 | ) | $ | (0.09 | ) | $ | (0.07 | ) | ||||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND DILUTED | 128,223,722 | 99,766,245 | 132,549,001 | 99,821,970 | ||||||||||||
| (1) Includes share-based compensation | $ | 163 | $ | 448 | $ | 43 | $ | 82 | ||||||||
| (2) Includes share-based compensation | $ | 128 | $ | 317 | $ | 32 | $ | 81 |