MediWound Ltd. (NASDAQ: MDWD) 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.
On Nov 13th, 2018, the company announced its financial results for the quarter ended September 30, 2018 and provided an update on its operations and upcoming milestones. This has been an active quarter, and MediWound continues to make progress on numerous fronts. Furthermore, alongside an improvement in business and financial profile, the company provided an important update on an M&A Potential.
Third Quarter Product and Pipeline Highlights:
- Revenues for the third quarter of 2018 were $0.9 million, a 16% increase from $0.7 million in the third quarter of 2017
- MediWound Awarded Additional Biomedical Advanced Research and Development Authority (BARDA) Contract Valued Up to $43 Million for Development of NexoBrid® for Sulfur Mustard Injuries
- NexoBrid® received marketing authorization from Russian’s Ministry of Health. Genfa Medica S.A., MediWound’s exclusive distribution partner in Russia, intends to launch NexoBrid in the first half of 2019
Management commentary on potential M&A:
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.”
Promising near-term milestone/Catalysts:
This quarter has been very active for MediWound and the company looks forward to continuing to progress its programs forward and announcing several important milestones including the top line acute data in its Phase 3 DETECT study for NexoBrid in January 2019, initiation of its clinical program for EscharEx in the U.S. and further global expansion of NexoBrid as certain of MDWD’ international distributors are expecting to gain regulatory approval and launch.
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Analyst ratings and target price:
Per www.marketbeat.com, Their average twelve-month price target is $12.50, suggesting that the stock has a possible upside of 159.34%. The high price target for MDWD is $14.00, and the low-price target for MDWD is $11.00.
Below are the excerpts of recent analyst rating/Price targets on the company:
About the Company: 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.
- NexoBrid: MediWound’s first innovative biopharmaceutical product, NexoBrid®, received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean and Russian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. 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.
- EscharEx: MediWound’s second innovative product, EscharEx® is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to a large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx® contains the same proteolytic enzyme technology as NexoBrid® and benefits from the wealth of existing development data on NexoBrid®. In two Phase 2 studies, EscharEx® has demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications.
Pipe Line & Other Development Projects
Recent news in details:
- The Company was awarded an additional BARDA contract for the development of NexoBrid® for Sulfur Mustard injuries. The contract provides approximately $12 millions 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 million for additional and subsequent development activities, including pivotal animal studies and FDA Biologics License Application (BLA) submission.
- Last enrolled patient in NexoBrid® Phase 3 DETECT study has completed the acute treatment and entered the follow-up period; the company is looking forward to announcing top-line results in January 2019. Additionally, MDWD continues to recruit patients in the U.S. and Europe for its expanded NexoBrid® Phase 3 CIDS study in children after receiving both FDA concurrence on the protocol and BARDA funding.
- As planned, MediWound has submitted its pivotal protocol for clinical development of EscharEx® to the FDA, and the management recently met with the Agency, received concurrence on many aspects, and suggested additional secondary efficacy endpoints on which MediWound was requested to provide additional information. The company plan to submit, the information, and subject to FDA concurrence, to initiate EscharEx® clinical development program in the first half of 2019.
- The company received 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 the company has secured from the European Medicines Agency (EMA) and the Israeli, Argentinian and South Korea’s Ministries of Health for the same indication. It also further validates MediWound’s 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
Revenue and profitability:
- 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 participation, were $1.1 million, an 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.
- 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.
Liquidity and financial flexibility:
- 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 on December 31, 2017.
- For the remainder of 2018, the Company intends to allocate its cash resources to advance the development of EscharEx® while BARDA fully funds the NexoBrid® development plans.
- The Company now expects cash used 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.
Key Stock Influences:
- Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.
- MDWD is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
- MDWD has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
- The company may experience financial, regulatory, or operational difficulties, which may impair its ability to commercialize their products.
- Biopharma space in itself is a high-risk sector due to uncertainties associated with the novel drug development. Therefore, a favorable outcome of the upcoming catalyst is necessary for the stock to retain its momentum.
- On Friday, January 4th, MDWD was at $4.37 on volume of 23KK shares exchanging hands. Market capitalization is $131.002 million. The current RSI is 37.77
- In the past 52 weeks, shares of MDWD have traded as low as $3.5570 and as high as $7.3500
- At $4.37, shares of MDWD are trading below its 50-day moving average (MA) at $5.27 and below its 200-day MA at $5.99
- The present support and resistance levels for the stock are at $4.72 & $4.98 respectively.
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