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Summary

  • Manufacturing and commercializing products to address unmet needs in the fields of severe burns, chronic and hard-to-heal wounds and connective tissue disorders.
  • Launched its first product in Europe in December 2013.
  • Plans to initiate a Phase 3 pivotal study in the United States in the first half of 2014.

Based in Yavne, Israel, MediWound (NASDAQ:MDWD) scheduled a $75 million IPO on the Nasdaq with a market capitalization of $306 million at a price range midpoint of $15 for Thursday, March 20, 2014.

The full IPO calendar is available at IPOpremium.

SEC Documents
Manager, Joint managers: Credit Suisse, Jefferies, BMO Capital Markets

Co-Managers: Oppenheimer & Co.

End of lockup (180 days): Tuesday, September 16, 2014

End of 25-day lockup period: Monday, April 14, 2014

Summary
MDWD is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, chronic and hard-to-heal wounds and connective tissue disorders.

Valuation

Glossary

Valuation Ratios

Mrkt

Price /

Price /

Price /

Price /

% offered

Dec 12 mos

Cap (MM)

Sls

Erngs

BkVlue

TanBV

in IPO

MediWound Ltd.

$306

n/a

-20

5.3

5.5

25%

Conclusion

MDWD launched its first product in Europe in December 2013.

Based on sales expectations, the IPO rating on MDWD is positive.

To put the conclusions and observations in context, the following is reorganized, edited and summarized from the full S-1 referenced above.

Business

MDWD is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, chronic and hard-to-heal wounds and connective tissue disorders.

MDWD's innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency, or EMA, in December 2012 for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns, also referred to as severe burns.

NexoBrid represents a new paradigm in burn care management and has clinically demonstrated, with statistical significance, the ability to non-surgically and rapidly remove the eschar, without harming viable tissue.

MDWD has devoted significant efforts to the research and development of its patented proteolytic enzyme technology upon which NexoBrid is based.

NexoBrid product launch

MDWD is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, chronic and hard-to-heal wounds and connective tissue disorders.

MDWD manufactures NexoBrid in a state-of-the-art, EMA-certified, cGMP-compliant, sterile pharmaceutical products manufacturing facility at headquarters in Yavne, Israel.

Clinical trials
MDWD plans to initiate a Phase 3 pivotal study in the United States in the first half of 2014 to support a Biologics License Application, or BLA, submission to the U.S. Food and Drug Administration, or FDA.

However, MDWD expects that it will be several years, if ever, before it has approval to commercialize NexoBrid for the treatment of burn wounds in the United States and other international markets.

Participation by Teva

Starting in 2007, MDWD entered into a number of agreements with Teva related to collaboration in the development, manufacturing and commercialization of solutions for the burn and chronic wound care markets. As of December 31, 2012, all of these agreements terminated.

Income statement, balance sheet adjustments

The Teva liability was reevaluated, and MDWD recorded a financial income of $2.4 million. Additionally, in connection with the revaluation of MDWD's option to repurchase shares from Teva, which was presented as a derivative instrument in the balance sheet, MDWD recorded nonrecurring financial income of approximately $15.4 million for the year ended December 31, 2012. The total repurchased shares, valued at $34.6 million, appear in the consolidated statements of changes in equity as treasury shares.

Growth Plan

Dividend Policy

No dividends are planned.

Intellectual Property

As of February 28, 2014, MDWD had been granted a total of 57 patents and have 18 pending national phase applications.

The family of patents that covers NexoBrid specifically includes 31 granted patents worldwide and five pending applications.

MDWD submits applications under the Patent Cooperation Treaty, or PCT, which is an international patent law treaty that provides a unified procedure for filing a single initial patent application to seek patent protection for an invention simultaneously in each of the member states.

Although a PCT application is not itself examined and cannot issue as a patent, it allows the applicant to seek protection in any of the member states through national-phase applications.

The main patents for MDWD's proteolytic enzyme technology, which underlies NexoBrid and MDWD's current pipeline products have been issued in Europe, the United States and other international markets.

Competition

While MDWD believes that its innovative technology, knowledge, experience and scientific resources provide it with competitive advantages, MDWD may face competition from many different sources with respect to NexoBrid and its pipeline products or any product candidates that MDWD may seek to develop or commercialize in the future.

Possible competitors may be medical practitioners, pharmaceutical and wound care companies, academic and medical institutions, governmental agencies and public and private research institutions, among others.

Any product that MDWD successfully develops and commercializes will compete with existing therapies and new therapies that may become available in the future.

In addition, MDWD faces competition from current SOC. The current SOC for eschar removal in severe burns is surgery, where debridement can be performed by tangential excision, dermabrasion or hydro jet, or non-surgical alternatives, such as applying topical medications to the eschar to facilitate the natural healing process.

Consequently, MDWD faces competition from surgical procedures and topical agents such as Smith & Nephew Plc's Santyl, a collagenase-based product indicated for the debriding chronic dermal ulcers and severely burned area.

However, based on its clinical trials, MDWD believes that NexoBrid has a sustainable competitive advantage over the current non-surgical alternatives and is less invasive than surgery in removing eschar in patients with burn wounds.

5% stockholders

Clal Biotechnology Industries Ltd. 63.5%

Harel Insurance Investments & Financial Services Ltd. 8.4%

Migdal Insurance and Finance Company Ltd. 8.0%

Lior Rosenberg 12.2%

Use of proceeds

MDWD expects to net $68 million from its IPO. Proceeds are allocated as follows:

$25-$30 million to expand its sales and marketing infrastructure;

$25-$30 million on research and development;

$10 million to expand its manufacturing capabilities; and

the balance, if any, for other general corporate purposes.

Disclaimer: This MDWD IPO report is based on a reading and analysis of MDWD's S-1 filing, which can be found here, and a separate, independent analysis by IPOdesktop.com. There are no unattributed direct quotes in this article.

Source: IPO Preview: MediWound