SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
______________________
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER
 
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
 
For the month of January 2016
 
Commission File Number: 001-36349
 
                  MediWound Ltd.                   
(Translation of registrant’s name into English)
 
42 Hayarkon Street
Yavne, 8122745 Israel
 (Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
Form 20-F x           Form 40-F o
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):   __

 

 
 
EXPLANATORY NOTE

On January 25, 2016, MediWound Ltd. issued a press release entitled “MediWound reports 2015 fourth quarter and full year financial results”. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.

2

 
 
SIGNATURE
 
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, thereunto duly authorized.
 
 	MEDIWOUND LTD.	 	
 	 	 	 	
Date: January 25, 2016  	By:	/s/ Sharon Malka	 	
 	 	Name: Sharon Malka	 	
 	 	Title:   Chief Financial Officer	 	

 
3

 

EXHIBIT INDEX

The following exhibit is filed as part of this Form 6-K:
 
Exhibit
 
99.1	Description
 
Press release dated January 25, 2016 titled “MediWound reports 2015 fourth quarter and full year financial results”.	
 
4

 

Exhibit 99.1

 
News Release

MediWound Reports 2015 Fourth Quarter and Full Year Financial Results

Conference call begins today at 8:30 a.m. Eastern time
 
YAVNE, Israel (January 25, 2016) – MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, reports financial results for the three and 12 months ended December 31, 2015.

Highlights of the fourth quarter of 2015 and recent weeks include:

 	·	Provided NexoBrid® as humanitarian aid for a mass casualty incident (MCI) in Romania	

 	·	Highlighted NexoBrid’s potential role in managing MCIs in several presentations at the 4th International Conference on Healthcare System Preparedness and Response to Emergencies and Disasters	

 	·	Appointed Aharon Yaari as Chairman of the Board of Directors and Dr. Roland Frosing as European Medical Director	

 	·	Received authorization from the Ministry of Health in Argentina to market and distribute NexoBrid for the removal of dead or damaged tissue in adults with deep partial and full-thickness thermal burns	

 	·	Expanded Latin American distribution of NexoBrid through agreement with Avalon Pharmaceutical S.A	

Management Commentary

“Throughout 2015 we made significant progress increasing awareness of and interest in NexoBrid throughout Europe as evidenced by more than 90 clinical presentations at premier medical meetings by numerous burn specialists highlighting NexoBrid's merits in a number of severe burn applications. We have trained more than 75% of the European burn centers while more than half of the burn centers in Europe have treated an increasing number of patients with NexoBrid every quarter. Internationally, we obtained marketing authorization for NexoBrid in Argentina, submitted registration files in Mexico, Russia and South Korea and expended the reach of NexoBrid to most of South America with the recent distribution agreement with Avalon. In addition, we made meaningful progress with our clinical development programs including the initiation of our U.S. Phase 3 study of NexoBrid to treat severe burns and the completion of enrollment in our second Phase 2 study of EscharEx ®  for the treatment of chronic and hard-to-heal wounds,” stated Gal Cohen, President and Chief Executive Officer of MediWound.

“Importantly, we entered a new market for NexoBrid in the preparedness for Mass Casualty Incidences (MCI) with the signing of a strategic agreement valued at up to $112 million with the U.S. Biomedical Advanced Research and Development Authority (BARDA) in late September.  This agreement provides non-dilutive funding for our NexoBrid U.S. development program and also has procurement commitments and options. We were particularly pleased to provide NexoBrid as humanitarian aid to victims of a MCI in Romania, where approximately 40 severe burn patients were treated with NexoBrid in less than 3 days, providing a real-world demonstration of the important role NexoBrid can play in such events where physician and surgical capacity are a bottleneck in saving patients’ lives. We believe this is an important market where we can jointly work with governments and militaries in an effort to better prepare for such inevitable occurrences.

 

 

“We were particularly pleased to complete our second Phase 2 study with EscharEx for the treatment of chronic and hard-to-heal wounds and we look forward to reporting top-line data in early February.  We are excited about the potential for EscharEx in these indications based on a comprehensive market study we performed with more than 200 healthcare professionals and our U.S. advisory board, both indicating the huge commercial potential for an approved product that meets this target product profile. As EscharEx is based on the same technology as NexoBrid, we believe that the wealth of existing development data for NexoBrid, as well as clinical data from our first Phase 2 feasibility study, de-risks EscharEx’s development as EscharEx benefits from the data developed for the European approval of NexoBrid including preclinical, toxicology, manufacturing and control data.
 
“The progress we made throughout 2015 puts us in a strong position to achieve a number of value-creating milestones during 2016, including the readout of top-line data from our Phase 2 study of EscharEx, the continued adoption of NexoBrid in Europe, the ongoing enrollment in our U.S. Phase 3 study of NexoBrid, expansion of NexoBrid as an important tool in managing MCIs and further commercialization of NexoBrid in international markets," concluded Mr. Cohen.
 
Fourth Quarter Financial Results

Revenues for the fourth quarter of 2015 increased to $267,000 compared with $124,000 for the same quarter last year, primarily due to sales of NexoBrid associated with the MCI in Romania, which were ordered in addition to the Company’s donation of product.

Operating expenses for the fourth quarter of 2015 were $6.4 million, in line with the Company’s expectations, compared with $5.6 million for the fourth quarter of 2014.  The increase was primarily due $0.8 million of research and development activities related to clinical development and $0.5 million of general and administrative expense, offset by a $0.5 million decrease in non-cash stock-based compensation expense.

For the fourth quarter of 2015, the Company reported a net loss of $7.8 million, or $0.36 per share, compared with a net loss of $7.1 million, or $0.33 per share, in the fourth quarter of 2014.

Adjusted EBITDA, as defined below, for the fourth quarter of 2014 was a loss $6.0 million compared with a loss of $5.3 million for the same quarter last year.

Full year Financial Results

For the 12 months ended December 31, 2015, revenues were $601,000, compared with $259,000 for the same period in 2014, representing primarily sales of NexoBrid in Europe and Israel in both periods.

Operating expenses for 2015 were $19.3 million, in line with expectations, compared with $18.9 million for 2014. The increase was primarily due to $1.2 million of commercial activities associated with the European marketing infrastructure and $0.8 million due to research and development activities related to clinical development, offset by a $1.7 million decrease in non-cash stock-based compensation expense.

 

 
 
The Company reported a net loss for 2015 of $22.1 million, or $1.02 per share, compared with a loss for 2014 of $18.9 million, or $0.95 per share in the prior year. The increase in net loss was primarily due to one-time net financial income recognized in 2014, which was largely comprised of non-cash revaluation of warrants.

Adjusted EBITDA, as defined below, for 2015 was a loss of $18.1 million, compared with a loss of $16.1 million for 2014.

Balance Sheet Highlights

As of December 31, 2015, the Company had cash and short-term deposits of $45.8 million, and working capital of $45.2 million.  The Company used $19.1 million to fund ongoing activities during 2015, which was in line with its guidance of $20.0 million.

During 2016 the Company will continue to invest primarily in its marketing infrastructure in Europe to advance the commercialization of NexoBrid and in research and development efforts of NexoBrid supported by BARDA funding as well as amplify the development of EscharEx for chronic wounds and other pipeline product candidates. As a result, cash use for the year is expected to be in the range of $20.0 million to $22.0 million.

Conference Call

MediWound management will host a conference call for members of the investment community today beginning at 8:30 a.m. Eastern time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the call by dialing (877) 280-2296 (domestic) or (1809) 212-925 (Israel) and entering passcode 8854485. The call also will be broadcast live on the Internet on the Company’s website at  www.mediwound.com .

A replay will be available beginning two hours after the completion of the live call through February 1, 2016 by dialing (866) 932-5017 (domestic) or (800) 358-7735 (UK) and entering passcode 8854485. The call will also be archived for 90 days on the Company’s website at  www.mediwound.com .

Non-IFRS Financial Measures

To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which is defined as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and stock-based compensation expenses.

Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not  believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining  compensation, and when assessing the performance of our business with our  senior management.

However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

 

 
 
About MediWound Ltd.

MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns and has been launched in Europe. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials and the regulatory authorizations. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the FDA or the EMA regulatory approval process or additional competition in the market. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
 
Contacts:
Sharon Malka
Chief Financial & Operations Officer
MediWound Ltd.
ir@mediwound.co.il	Anne Marie Fields
Senior Vice President
LHA
212-838-3777
afields@lhai.com	
 
- Financial Tables to Follow -

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS 

U.S. dollars in thousands
 
 	 	December 31,	 	
 	 	2015	 	 	2014	 	
CURRENT ASSETS:	 	 	 	 	 	 	
Cash, cash equivalents and short term deposits	 	 	45,768	 	 	 	64,853	 	
Accounts and other receivable	 	 	2,912	 	 	 	2,223	 	
Inventories	 	 	1,715	 	 	 	1,421	 	
 	 	 	50,395	 	 	 	68,497	 	
LONG-TERM ASSETS:	 	 	 	 	 	 	 	 	
Long term deposits	 	 	192	 	 	 	168	 	
Property, plant and equipment, net	 	 	1,040	 	 	 	1,088	 	
Intangible assets, net	 	 	896	 	 	 	951	 	
Other assets	 	 	-	 	 	 	417	 	
 	 	 	52,523	 	 	 	71,121	 	
CURRENT LIABILITIES:	 	 	 	 	 	 	 	 	
Trade payables	 	 	1,123	 	 	 	1,214	 	
Accrued expenses and other payables	 	 	4,083	 	 	 	2,683	 	
 	 	 	5,206	 	 	 	3,897	 	
LONG-TERM LIABILITIES:	 	 	 	 	 	 	 	 	
Liabilities in respect of Chief Scientist government grants net of current maturities	 	 	7,275	 	 	 	6,985	 	
Contingent consideration for the purchase of treasury shares net of current maturities	 	 	16,475	 	 	 	17,361	 	
Severance pay liability, net	 	 	97	 	 	 	7	 	
 	 	 	23,847	 	 	 	24,353	 	
 	 	 	 	 	 	 	 	 	
SHAREHOLDERS' EQUITY	 	 	23,470	 	 	 	42,871	 	
 	 	 	52,523	 	 	 	71,121	 	

 

 
 
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

U.S. dollars in thousands (except share and per share data)
 
 	 	Year ended	 	 	Three months ended	 	
 	 	December 31,	 	 	December 31,	 	
 	 	2015	 	 	2014	 	 	2015	 	 	2014	 	
 	 	 Audited	 	 	Unaudited	 	
Revenues	 	 	601	 	 	 	259	 	 	 	267	 	 	 	124	 	
Cost of revenues	 	 	2,519	 	 	 	2,785	 	 	 	689	 	 	 	1,142	 	
Gross loss	 	 	(1,918	)	 	 	(2,526	)	 	 	(422	)	 	 	(1,018	)	
Operating expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Research and development, net	 	 	6,021	 	 	 	5,349	 	 	 	2,294	 	 	 	1,496	 	
Selling, general & administrative	 	 	13,288	 	 	 	13,552	 	 	 	4,114	 	 	 	4,072	 	
Total operating expenses	 	 	19,309	 	 	 	18,901	 	 	 	6,408	 	 	 	5,568	 	
Operating loss	 	 	(21,227	)	 	 	(21,427	)	 	 	(6,830	)	 	 	(6,586	)	
Financial income (expenses), net	 	 	(444	)	 	 	2,552	 	 	 	(950	)	 	 	(508	)	
Loss from continuing operations	 	 	(21,671	)	 	 	(18,875	)	 	 	(7,780	)	 	 	(7,094	)	
Loss from discontinued operation	 	 	(417	)	 	 	-	 	 	 	-	 	 	 	-	 	
Loss for the period	 	 	(22,088	)	 	 	(18,875	)	 	 	(7,780	)	 	 	(7,094	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Foreign currency translation adjustments	 	 	2	 	 	 	14	 	 	 	1	 	 	 	(27	)	
Total comprehensive loss	 	 	(22,086	)	 	 	(18,861	)	 	 	(7,779	)	 	 	(7,121	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Basic and diluted loss per share:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Loss from continuing operations	 	 	(1.00	)	 	 	(0.95	)	 	 	(0.36	)	 	 	(0.33	)	
Loss from discontinued operation	 	 	(0.02	)	 	 	0.00	 	 	 	0.00	 	 	 	0.00	 	
Net loss per share	 	 	(1.02	)	 	 	(0.95	)	 	 	(0.36	)	 	 	(0.33	)	
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:	 	 	21,674	 	 	 	19,940	 	 	 	21,801	 	 	 	21,298	 	

 

 
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 	 	Year ended	 	 	Three months ended	 	
 	 	December 31,	 	 	December 31,	 	
 	 	2015	 	 	2014	 	 	2015	 	 	2014	 	
 	 	Audited	 	 	Unaudited	 	
Cash Flows from Operating Activities:	 	 	 	 	 	 	 	 	 	 	 	 	
Net loss	 	 	(22,088	)	 	 	(18,875	)	 	 	(7,780	)	 	 	(7,094	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Adjustments to reconcile net loss to net cash used in continuing operating activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Adjustments to profit and loss items:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Loss from discontinued operation	 	 	417	 	 	 	-	 	 	 	-	 	 	 	-	 	
Depreciation and amortization	 	 	503	 	 	 	492	 	 	 	153	 	 	 	88	 	
Revaluation of warrants to shareholders	 	 	-	 	 	 	(4,491	)	 	 	-	 	 	 	-	 	
Share-based compensation	 	 	2,659	 	 	 	4,827	 	 	 	699	 	 	 	1,204	 	
Revaluation of liabilities in respect of Chief Scientist government grants	 	 	(474	)	 	 	87	 	 	 	470	 	 	 	55	 	
Revaluation of contingent consideration for the purchase of treasury shares	 	 	(764	)	 	 	612	 	 	 	597	 	 	 	55	 	
Increase in severance liability, net	 	 	90	 	 	 	-	 	 	 	90	 	 	 	-	 	
Net financing expenses (income)	 	 	(219	)	 	 	226	 	 	 	(209	)	 	 	(52	)	
 	 	 	2,212	 	 	 	1,753	 	 	 	1,800	 	 	 	1,350	 	
Changes in asset and liability items:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Increase in trade receivables	 	 	(181	)	 	 	(67	)	 	 	(134	)	 	 	(46	)	
Decrease (increase) in other receivables	 	 	(556	)	 	 	186	 	 	 	(666	)	 	 	103	 	
Decrease (increase) in inventories	 	 	(273	)	 	 	(1,421	)	 	 	84	 	 	 	161	 	
Increase (decrease) in trade payables	 	 	(76	)	 	 	22	 	 	 	(124	)	 	 	301	 	
Increase in other payables	 	 	1,361	 	 	 	1,909	 	 	 	1,933	 	 	 	844	 	
 	 	 	275	 	 	 	629	 	 	 	1,093	 	 	 	1,363	 	
Net cash flows used in operating activities	 	 	(19,601	)	 	 	(16,493	)	 	 	(4,887	)	 	 	(4,381	)	
Cash Flows from Investment Activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Purchase of property and equipment	 	 	(376	)	 	 	(366	)	 	 	(78	)	 	 	61	 	
Purchase of intangible assets	 	 	(30	)	 	 	(30	)	 	 	(30	)	 	 	(30	)	
Interest received	 	 	287	 	 	 	173	 	 	 	203	 	 	 	128	 	
Proceeds from (investment in) short term bank deposits, net of investments	 	 	36,165	 	 	 	(36,931	)	 	 	21,989	 	 	 	10,643	 	
Net cash provided by (used in) investing activities	 	 	36,046	 	 	 	(37,154	)	 	 	22,084	 	 	 	10,802	 	
Cash Flows from Financing Activities:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Proceeds from exercise of options	 	 	26	 	 	 	306	 	 	 	-	 	 	 	98	 	
Proceeds from issuance of shares and warrants, net	 	 	-	 	 	 	71,824	 	 	 	-	 	 	 	-	 	
Proceeds from the Chief Scientist government grants, net of repayments	 	 	752	 	 	 	345	 	 	 	643	 	 	 	66	 	
Net cash provided by financing activities	 	 	778	 	 	 	72,475	 	 	 	643	 	 	 	164	 	
Exchange rate differences on cash and cash equivalent balances	 	 	(143	)	 	 	(459	)	 	 	112	 	 	 	(96	)	
Increase in cash and cash equivalents	 	 	17,223	 	 	 	18,828	 	 	 	17,840	 	 	 	6,585	 	
Balance of cash and cash equivalents at the beginning of the period	 	 	25,422	 	 	 	7,053	 	 	 	24,550	 	 	 	18,933	 	
Balance of cash and cash equivalents at the end of the period	 	 	42,502	 	 	 	25,422	 	 	 	42,502	 	 	 	25,422	 	

 

 
 
RECONCALIATION OF NET LOSS TO ADJUSTED EBITDA

U.S. dollars in thousands

 	 	Year ended	 	 	Three months ended	 	
 	 	December 31,	 	 	December 31,	 	
 	 	2015	 	 	2014	 	 	2015	 	 	2014	 	
Loss for the period	 	 	(22,088	)	 	 	(18,875	)	 	 	(7,780	)	 	 	(7,094	)	
Adjustments:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Financial (expenses) income, net	 	 	(444	)	 	 	2,552	 	 	 	(950	)	 	 	(508	)	
Loss from discontinued operation	 	 	(417	)	 	 	-	 	 	 	-	 	 	 	-	 	
Depreciation and amortization	 	 	(503	)	 	 	(492	)	 	 	(153	)	 	 	(88	)	
Share-based compensation expenses	 	 	(2,659	)	 	 	(4,827	)	 	 	(699	)	 	 	(1,204	)	
Total adjustments	 	 	(4,023	)	 	 	(2,767	)	 	 	(1,802	)	 	 	(1,800	)	
Adjusted EBITDA from continuing operation	 	 	(18,065	)	 	 	(16,108	)	 	 	(5,978	)	 	 	(5,294	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Share-based compensation and options expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of revenues	 	 	372	 	 	 	763	 	 	 	101	 	 	 	188	 	
Research and development	 	 	511	 	 	 	657	 	 	 	136	 	 	 	163	 	
Selling and marketing	 	 	669	 	 	 	1,430	 	 	 	189	 	 	 	351	 	
General and administrative	 	 	1,107	 	 	 	1,977	 	 	 	273	 	 	 	502	 	
Total share-based compensation expenses	 	 	2,659	 	 	 	4,827	 	 	 	699	 	 	 	1,204