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Upcoming Catalysts Make MediWound a Stock to Watch Out for!

02 Mar Upcoming Catalysts Make MediWound a Stock to Watch Out for!

MediWound Ltd (NASDAQ: MDWD), a Company creating cutting-edge solutions for tissue repair and regeneration, recently announced its Q4 and Full-year 2020 Financial results. While the revenue was up by 23 percent, at $6.7 Million, compared to $5.4 million for the same period in 2019, product revenues stood at $7.8 million, an increase of 117% compared with the full year of 2019, driven by the initiation of the BARDA emergency stockpile procurement.

Sharon Malka, Chief Executive Officer of MediWound, commented,

“I am very proud of our team’s perseverance and resilience in delivering positive results in our clinical programs and financial performance despite the enormous COVID-19 challenges that we all face globally. We look forward to 2021 as a pivotal year of important catalysts for MediWound. “We remain focused on our continued growth with the advancement of our EscharEx clinical program with a U.S phase 2 study interim assessment later this year. NexoBrid’s global expansion continues as we look forward to NexoBrid’s BLA approval in 2021. Finally, we are excited to initiate the clinical development program of MWPC005 as a treatment for BCC, leveraging our platform technology to enhance our diverse and innovative portfolio.”

The Company is looking forward to some major catalysts in 2021, including the Prescription Drug User Fee Act (PDUFA) of NexoBrid on June 29, 2021, additional deliveries due to BARDA of NexoBrid for emergency stockpile in 2021, enrolment in NexoBrid’s pivotal Phase 3 (CIDS) study, besides results from a U.S. phase I/II clinical study for the treatment of basal cell carcinoma (BCC), expected to be made available in Q2,2021.

MediWound Ltd (NASDAQ: MDWD)

Market Cap: $148.72M; Current Share Price: 5.48 USDChart
Data by YCharts

The Global Wound Care market
is poised to reach USD 24.8 billion by 2024, growing at a CAGR of 4.6% from USD 19.8 billion in 2019 as per a report by Markets and Markets. The advanced state of medical services, rise in disposable income, increased awareness and early intervention, advances in technology, increasing geriatric population, higher incidences of diabetes, Ulcers, obesity and a growing number of surgical procedures are providing impetus to the growth in the industry.

Introduction of new technology such as tissue sealants, negative pressure therapy systems, and synthetic skin replacements are changing the landscape of the industry. Novel therapies such as nanotechnology, use of silver, electrical stimulation and electromagnetic are making wound care products more comfortable and flexible than traditional wound care products. The focus is to create epithelialization by lessening the frequency of changing required, thereby fastening the healing process.

Image Source: Company

A niche specialist in the severe Burn and chronic wound management category, MediWound’s innovative NexoBrid®, that uses its patented proteolytic enzyme technology, is used for treating eschar in adults with deep partial and full thickness thermal burns. It enjoys orphan drug status in the U.S and E.U markets along with patent protection and exclusivity for 7 and 10 years. The product was approved by the EMA in December 2012.

In September 2020, the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, with a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. The Company has entered into a strategic partnership with BARDA and a commercial collaboration with Vericel in the North American market, which provides it with milestone payments and royalty payments. In addition, MediWound is pursuing global expansion of NexoBrid through distribution agreements.

The company also has other novel products in the pipeline. EscharEx a topical drug for application in chronic, difficult-to-heal wounds has undergone two phase 2 trials and has demonstrated clinical efficacy in the debridement of chronic wounds. The candidate fulfils an unmet need for non-surgical debridement treatment for severe burns, which currently faces challenges such as limited efficacy and higher eschar-related morbidities. MediWound is likely to provide data from an interim analysis in H1,2021.

MWPC003, the Company’s lead candidate for the treatment of connective tissue disorders such as Scars, Dupuytren’s Contracture and Peyronie’s Disease has completed preclinical studies. In February 2021, the Company initiated clinical development of MWPC005 in patients with non-melanoma skin cancer. The candidate is already being evaluated for the treatment of basal cell carcinoma (BCC) and the Company has submitted a protocol to the FDA for a phase I/II clinical study in the U.S, which is likely to be initiated in Q2,2021.

Image Source: Company

The company has been awarded a U.S Biomedical Advanced Research and Development Authority (BARDA) Contract Valued Up to $43 Million for Development of NexoBrid® for Sulfur Mustard Injuries. The contract also provides an additional $12 million for research and development activities under the FDA Animal Rule. The up to eight-year contract also provides for an additional funding of $31 million for other development activities, animal pivotal studies, and the FDA Biologics License Application (BLA) submission. Additionally, the Company will receive nearly $159M from BARDA for development of NexoBrid in Thermal Burns.

Key Takeaways

  • The Company believes that the Targeted Addressable Market for NexoBrid is more than 200 million in the U.S alone. In addition, Eschar EX is a potential $2 billion opportunity, while MWPC003, its injectable enzyme therapy is likely to address a $1 billion market. MediWound’s commercial strategy involves targeting sites of care such as outpatient departments in hospitals, wound care clinics and nursing and homecare services, besides engaging vascular specialists, plastic surgeons and primary care physicians. The Company intends to make use of existing reimbursement codes for enzymatic debridement, namely Hospital Outpatient Prospective Payment System (OPPS) code 97602.
  • MediWound programs are fully funded by BARDA and enjoy significant government support. In fact, BARDA has initiated a procurement agreement with NexoBrid for a strategic national stockpile. The Company has been chosen to fulfill a $16.5 million procurement order with an option for $50 million in additional procurement. Furthermore, the Company has entered into a commercial collaboration with Vericel and will receive $7.5M upon U.S. BLA approval and additionally, will receive tiered royalty payments and nearly $125M in annual sales milestones. The deal enables NexoBrid to gain access to Vericel’s active commercial infrastructure and expertise in the burn care market.
  • The Company has extensive presence in four key markets such as France and Switzerland in the EU and a direct sales force that is focused on burn centers. MediWound is also pursuing additional regional marketing approvals in the international market, wherein the distributor is responsible for registration and commercialization activities. The Company has also entered the Middle Eastern market with the signing of a distribution agreement in the United Arab Emirates.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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