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News Release          

 

NexoBrid^® sales grow 60% in 2017 vs. 2016

Raised gross proceeds of $25.2 million through an equity offering

to fund EscharEx^® clinical plan

Awarded additional $32 million from BARDA

bringing NexoBrid^® to be self-funded program

Announces discussions regarding potential strategic transaction

 

Conference call begins today at 8:30 a.m. Eastern Time

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At the current recruitment rate, we plan to complete the recruitment of 175 patients to our ongoing NexoBrid^® U.S. Phase 3 DETECT study around mid-2018 and report the primary, secondary and safety acute topline data around year-end, following a 3 month follow-up. MediWound is also expanding the pediatric Phase 3 CIDS study into the U.S. We have submitted the protocol to the IRBs and expect to open the sites in the first half of 2018,” noted Mr. Cohen.

 

The Company posted a net loss of $2.4 million, or $0.09 per share, for the fourth quarter of 2017 compared with a net loss of $1.9 million, or $0.09 per share, for the fourth quarter of 2016. The increase in net loss was primarily as a result of non-cash financial income from revaluation of contingent liabilities recorded in 2016.

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Research and development expenses for the year ended December 31, 2017, net of participations, were $5.5 million, down 23% compared to the $7.1 million recorded in the year ended December 31, 2016. The decrease was primarily due to an increase of $1.5 million in participation by BARDA and the Israeli Innovation Authority in the Company’s R&D expenses.

Operating loss for the year ended December 31, 2017 was $13.7 million, an improvement of 32% versus an operating loss of $20.2 million recorded in the year ended December 31, 2016. The decrease was primarily due to the positive change in gross profit in 2017 and the decrease of approximately $5 million in operating expenses compared to the prior year period.

For the year ended December 31, 2017, the Company posted a net loss of $22.1 million, or $0.95 per share, compared with a net loss of $18.9 million, or $0.86 per share, for year ended December 31, 2016. The change in net loss is comprised of: (i) a decrease of $4.4 million in net loss from continuing operations, primarily due to a $6.5 million decrease in operating loss which was offset by an increase of $2.1 million net financial expenses, largely comprised of non-cash revaluation of contingent liabilities; and (ii) a one-time loss from discontinued operation of $7.6 million for 2017, following a full provision for the share purchase price plus the accrued interest, that was recorded as a result of the district court ruling.

Adjusted EBITDA, as defined below, for the year ended December 31, 2017 was a loss of $11.8 million, compared with a loss of $16.4 million for the year ended December 31, 2016.

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MediWound management will host a conference call for investors today, Monday, March 19, 2018 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 800-289-0438 (in the U.S.)  1-80-921-2883 (Israel), or 323-794-2423 (outside the U.S. & Israel) and entering passcode 5767650. The call also will be broadcast live on the Internet on the Company’s website at http://ir.mediwound.com/events.cfm.

A replay of the call will be accessible two hours after its completion through March 22, 2018 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 5767650. The call will also be archived on the Company website for 90 days at www.mediwound.com.

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, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid^®, received marketing authorization from the European Medicines Agency as well as the Israeli and Argentinian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns and was launched in Europe and Israel and Argentina. 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.

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 the regulatory authorizations and launch dates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. 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. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2017 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. 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:	Bob Yedid
Sharon Malka	Managing Director
Chief Financial and Operations Officer	LifeSci Advisors
MediWound Ltd.	646-597-6989
ir@mediwound.co.il	bob@lifesciadvisors.com

 

MediWound, Ltd.

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

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MediWound, Ltd.

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

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ADJUSTED EBITDA

U.S. dollars in thousands

 

 

MediWound, Ltd.

CONDENSED CONSOLIDATED CASH FLOW

U.S. dollars in thousands