PLX Protalix BioTherapeutics Inc

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

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FORM 8-K

 

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): August 10, 2015

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Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

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Florida		001-33357		65-0643773
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

2 Snunit Street		20100
Science Park, POB 455
Carmiel, Israel
(Address of principal executive offices)		(Zip Code)

 

Registrant's telephone number, including area code +972-4-988-9488

 

 

(Former name or former address, if changed since last report.)

 

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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Item 2.02. Results of Operations and Financial Condition

 

On August 10, 2015, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2015. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d)

Exhibits

 

99.1

Press release dated August 10, 2015.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

	PROTALIX BIOTHERAPEUTICS, INC.
Date: August 10, 2015	By:		/s/ Moshe Manor
	Name:		Moshe Manor
	Title:		President and Chief Executive Officer

 

 

Exhibit 99.1

 

Protalix BioTherapeutics Reports Second Quarter 2015 Financial Results

Net Losses narrowed with clinical progress in all three product candidates

  

CARMIEL, Israel, August 10, 2015 -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the second quarter of 2015.

 

“We recently reported positive Phase I results for PRX-106 (oral Anti-TNF), with exciting results showing biological activity in the gut and activation of regulatory T cells,” said Moshe Manor, Protalix’s President and Chief Executive Officer. “We look forward to selecting an indication and moving this program into proof of concept trial around year-end. Additionally, we anticipate interim results for PRX-102 for the treatment of Fabry disease in September, including 6-month data for the 1mg/kg dose group and 12-month data for the 0.2mg/kg group. We also expect to initiate a proof of concept study for AIR DNase^TM in Cystic Fibrosis patients early next year.”

 

Financial Results for the Period Ended June 30, 2015

 

•     Net loss narrowed to $5.1 million, or $0.05 per share, for the three months ended June 30, 2015, down $1.0 million, or 17%, from $6.1 million, or $0.07 per share, for the same period in 2014.

 

•     Total revenues for the three months ended June 30, 2015 were $3.8 million compared to $2.4 million in the same period in 2014. The increase resulted primarily from an increase of $1.3 million in sales in Brazil compared to the same period in 2014.

 

•     Revenue from the Company’s share of net income from the collaboration under the Pfizer agreement increased by $573,000, to $834,000 for the three months ended June 30, 2015 compared to $261,000 for the same period in 2014.

 

•     Total worldwide sales of Elelyso^TM during the six months ended June 30, 2015 were $15.8 million, an increase of $2.7 million, or 21%, compared to worldwide sales of $13.1 million for the six months ended June 30, 2014.

 

•     Cost of revenues was $4.4 million for the six months ended June 30, 2015 compared to $5.7 million for the same period in 2014.

 

•     Selling, general and administrative expenses decreased 24% to $4.0 million for the six months ended June 30, 2015 compared to $5.3 million for six months ended June 30, 2014. The decrease resulted primarily from a decrease of $1.0 million in salaries expenses, and the devaluation of the New Israeli Shekel against the U.S. Dollar during the period.

 

•     Cash and cash equivalents as of June 30, 2015 were $43.2 million representing an average quarterly cash consumption of approximately $5.8 million, a $1.9 million decrease compared to the same period in 2014.

 

 

Second Quarter and Recent Clinical and Corporate Highlights

 

•     The Company is actively discussing with Fundação Oswaldo Cruz (“Fiocruz”) potential actions that Fiocruz may take to comply with its purchase obligations under the Tech Transfer and Supply agreement since, as of July 31, 2015, Fiocruz has not yet achieved its minimum purchase obligation thereunder. The Company is, at this time, continuing to supply Uplyso^TM to Fiocruz under the agreement, and patients continue to be treated with Uplyso in Brazil, as approximately 10% of adult Gaucher patients in Brazil are currently treated with Uplyso.

 

•     Ex-vivo efficacy studies in Cystic Fibrosis patients’ sputum DNase show greater efficiency of AIR DNase compared to Pulmozyme® by reducing sputum viscoelasticity and DNA content. Toxicology studies of AIR DNase are being concluded to support the initiation of a phase I clinical study in healthy volunteers during the next quarter followed by a proof of concept study in Cystic Fibrosis patients early next year.

 

•     Phase I data for PRX-106 received in July demonstrate a favorable safety profile as well as biological activity in the gut and the activation of regulatory T cells.

 

•     The Company has commenced upgrading its manufacturing facility to become a multiproduct facility and support the manufacturing of PRX-102, in addition to taliglucerase alfa in a commercial scale. The Company expects that the upgraded facility will be able to support the worldwide marketing needs of both products. Due to the Company’s unique platform technology, the Company does not expect that these efforts will entail additional capital expenditures.

 

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, by Israel’s Ministry of Health in September 2012, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in April 2013, by the Australian Therapeutic Goods Administration(TGA) in May 2014 and by the regulatory authorities of other countries. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel and 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, also 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 the United States, Israel, Brazil, Canada, Australia and other countries; 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.

 

Investor Contact

 

Marcy Nanus

The Trout Group, LLC

646-378-2927

mnanus@troutgroup.com

 

Source: Protalix BioTherapeutics, Inc.

 

 

PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)

 

 

		June 30, 2015				December 31, 2014
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	43,238			$	54,767
Accounts receivable - Trade			1,936				1,884
Other assets			2,326				2,202
Inventories			6,368				6,667
Total current assets			53,868				65,520
FUNDS IN RESPECT OF EMPLOYEE
RIGHTS UPON RETIREMENT			1,596				1,555
PROPERTY AND EQUIPMENT, NET			10,392				11,282
DEFERRED CHARGES			98				113
Total assets		$	65,954			$	78,470
LIABILITIES NET OF CAPITAL DEFICIENCY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade		$	4,275			$	3,951
Other			14,316				15,496
Deferred revenues			6,928				6,763
Total current liabilities			25,519				26,210
LONG TERM LIABILITIES:
Convertible notes			67,670				67,464
Deferred revenues			35,614				37,232
Liability in connection with collaboration operation							912
Liability for employee rights upon retirement			2,288				2,253
Total long term liabilities			105,572				107,861
Total liabilities			131,091				134,071
COMMITMENTS
CAPITAL DEFICIENCY			(65,137	)			(55,601	)
Total liabilities net of capital deficiency		$	65,954			$	78,470

 

 

 

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, 2015				June 30, 2014				June 30, 2015				June 30, 2014
REVENUES		$	8,174			$	9,121			$	3,782			$	2,425
COMPANY’S SHARE IN COLLABORATION AGREEMENT			1,539				948				834				261
COST OF REVENUES			(4,439	)			(5,678	)			(2,039	)			(1,605	)
GROSS PROFIT			5,274				4,391				2,577				1,081
RESEARCH AND DEVELOPMENT EXPENSES (1)			(13,233	)			(15,228	)			(6,471	)			(7,076	)
Less – grants and reimbursements			2,649				4,199				1,514				2,114
RESEARCH AND DEVELOPMENT EXPENSES, NET			(10,584	)			(11,029	)			(4,957	)			(4,962	)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)			(4,005	)			(5,277	)			(2,092	)			(1,566	)
OPERATING LOSS			(9,315	)			(11,915	)			(4,472	)			(5,447	)
FINANCIAL EXPENSES			(1,799	)			(1,789	)			(642	)			(874	)
FINANCIAL INCOME			71				240				43				202
FINANCIAL EXPENSES – NET			(1,728	)			(1,549	)			(599	)			(672	)
NET LOSS FOR THE PERIOD		$	(11,043	)		$	(13,464	)		$	(5,071	)		$	(6,119	)
NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED:		$	(0.12	)		$	(0.15	)		$	(0.05	)		$	(0.07	)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE – BASIC AND DILUTED:			93,418,666				92,754,640				93,635,213				92,820,897
(1) Includes share-based compensation			409				591				283				163
(2) Includes share-based compensation			564				(14	)			271				(256	)