january, 2019

01janAll Day31MDWD Phase 3 NexoBrid

Event Details

NexoBrid for severe burns. Phase 3 data due January 2019.

MediWound Reports Third Quarter 2018 Financial Results

Awarded additional BARDA contract valued up to $43 Million for the development of NexoBrid® for sulfur mustard injuries

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

YAVNE, Israel, Nov. 13, 2018 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the three and nine months ended September 30, 2018.

Third Quarter Highlights:

“This has been an active quarter, and we continue to make progress on numerous fronts. We were very pleased to have been awarded an additional BARDA contract for the development of NexoBrid® for Sulfur Mustard injuries,” commented Gal Cohen, MediWound’s President and Chief Executive Officer. “The contract provides approximately $12 million of funding to support research and development activities up to pivotal studies in animals, under the U.S. Food and Drug Administration (FDA) Animal Rule, allowing for marketing approval based on animal studies. It also includes options for additional funding of up to $31 millionfor additional and subsequent development activities, including animal pivotal studies and FDA Biologics License Application (BLA) submission.”

“Now that the last enrolled patient in our NexoBrid® Phase 3 DETECT study has completed the acute treatment and entered the follow-up period, we look forward to announcing top line results in January 2019,” added Mr. Cohen. “Additionally, we continue to recruit patients in the U.S. and Europe for our expanded NexoBrid® Phase 3 CIDS study in children after receiving both FDAconcurrence on the protocol and BARDA funding. As planned, we have submitted our pivotal protocol for clinical development of EscharEx® to the FDA, and we recently met with the Agency. We had a constructive discussion, received concurrence on many aspects, and suggested additional secondary efficacy endpoints on which we were requested to provide additional information. We plan to submit, the information, and subject to FDA concurrence, to initiate EscharEx® clinical development program in the first half of 2019.”

“Finally, we were also happy to receive marketing authorization from the Russian Ministry of Health to sell NexoBrid® to patients with deep partial and full-thickness thermal burns. This authorization augments additional clearances we have secured from the European Medicines Agency (EMA) and from the Israeli, Argentinian and South Korea’s Ministries of Health for the same indication. It also further validates our strategy of using the EMA approved registration file for seeking approval in international markets through collaboration with local companies that possess the expertise in the local regulatory, market access and marketing efforts, and assume the financial commitment and diligence,” concluded Mr. Cohen.

Stephen T. Wills, MediWound’s Chairman, added, “As we have discussed in our prior earnings calls, MediWound was approached earlier this year by a third party to consider a potential strategic transaction. Subsequently, we engaged an investment bank to help us review the proposal and advise in our discussions.  We commenced discussions, and thereafter, received approaches and engaged in discussions and diligence with other strategic parties on different strategic transaction scenarios. At this stage, we continue to be in discussions and diligence with a subset of those parties. The Board continues to be advised by Moelis & Company regarding evaluation and assessment of all strategic options and avenues. As we have said, there can be no assurances that a definitive agreement between the parties or any other agreement will be reached.”

Third Quarter Financial Results
Revenues for the third quarter of 2018 were $0.9 million, an increase of 16% compared to $0.7 million of revenues for the third quarter of 2017.

Gross profit for the third quarter of 2018 was $0.5 million, compared to a gross profit of $0.4 million for the third quarter of 2017.

Research and development expenses for the third quarter of 2018, net of participations, were $1.1 million, increase of 26% compared with $0.8 million for the third quarter of 2017. The increase was as a result of an increase of $1.5 million in the gross research and development expenses, which was offset by an increase of $1.2 million in participation, primarily by BARDA.

Selling, general and administrative expenses for the third quarter of 2018 were $1.6 million, compared with $2.4 million for the third quarter of 2017.

Operating loss for the third quarter of 2018 was $2.2 million, an improvement of 20% from $2.8 million in the third quarter of 2017, as a result of the decrease in operating expenses.

The Company posted a net loss of $2.9 million, or ($0.11) per share, for the third quarter of 2018 compared with a net loss of $11.0 million, or ($0.49) per share, for the third quarter of 2017.
The Company’s net loss in 2017 included one-time loss from discontinued operation in the amount of $7.5 million as a result of the district court ruling and a full provision for the PolyHeal’s shares purchase price plus the accrued interest.

Adjusted EBITDA, as defined below, for the third quarter of 2018 was a loss of $2.0 million, compared with a loss of $2.3million for the third quarter of 2017.

Year-to-Date 2018 Financial Results 
Revenues for the first nine months of 2018 were $2.4 million compared with $2.0 million for the first nine months of 2017, an increase of 23%.

Gross profit for the first nine months of 2018 was $1.0 million, compared with a gross profit of $0.8 million in the prior year period, reflecting a gross margin of 40%.

Research and development expenses, net of participations, were $3.8 million for the first nine months of 2018, compared with $4.3 million for the first nine months of 2017. The decrease in research and development, net, was as a result of an increase of $3.8 million primarily in NexoBrid® clinical trials expenses, which was offset by an increase of $4.3 million in participations in the Company’s R&D expenses, primarily by BARDA.

Selling, general and administrative expenses in the first nine months of 2018 were $5.8 million compared with $6.7 million in the prior year period.

Operating loss for the first nine months of 2018 was $9.2 million, down 9% from $10.2 in the first nine months of 2017. Operating expenses in the first nine months of 2018 included other one-time expenses of $0.7 million associated with review and analysis of potential strategic transactions. The decrease in operating loss was primarily due to the increased revenues and the decrease in operating expenses in the first nine months of 2018 compared to the prior year period, which was offset by one-time other expenses as mentioned above.

For the nine months ended September 30, 2018, the Company posted a net loss of $11.7 million, or ($0.43) per share, compared with a net loss of $19.8 million, or ($0.89) per share, for the same period in 2017. The Company’s net loss in 2017 included one-time loss from discontinued operation in the amount of $7.5 million as a result of the district court ruling and a full provision for the PolyHeal’s shares purchase price.

Adjusted EBITDA, as defined below, for the nine months of 2018 was a loss of $7.6 million, compared with a loss of $8.7 million for the first nine months of 2017.

Balance Sheet Highlights
As of September 30, 2018, the Company had cash, cash equivalents and short-term bank deposits of $25.7 million, compared with $36.1 million at December 31, 2017.

For the remainder of 2018, the Company intends to allocate its cash resources to advance the development of EscharEx® while the NexoBrid® development plans are fully funded by BARDA.

We now expect cash use to support ongoing operating activities in 2018 will be in the range of $13 to $14 million, lower than the Company’s previous guidance for 2018 of $14.0 million to $16.0 million.



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