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MediWound: Managing A Position Ahead Of NexoBrid's PDUFA

May 02, 2021 5:16 AM ETMediWound Ltd. (MDWD)30 Comments


  • MediWound is preparing for NexoBrid's PDUFA date that is scheduled in June of this year. If approved, NexoBrid will be entering a $200M TAM with numerous benefits over the standard-of-care.
  • I provide some background on NexoBrid and point out some key data points that support approval.
  • FDA PDUFA events are binary events that create extreme volatility in the weeks leading up to the action date and after the FDA decision. I discuss my strategy for MDWD.

Doctor bandaging the wrist. Concept of first aids and treatment in wrist injuries.
Photo by Siriporn Lin/iStock via Getty Images

MediWound (NASDAQ:MDWD) continues to execute in the clinic, in the C-Suite, and on the balance sheet. Now, the company is waiting to see if the FDA will give them the green light to start executing

This article was written by

Biologics profile picture

Biologics is a full-time healthcare investor who developed a passion for biotech and life saving therapies after working in the medical field for years. His trade focus is around innovative companies developing breakthrough therapies and/or pharmaceuticals with catalysts for potential acquisitions.

He is the leader of the investing group Compounding Healthcare. Features of the group include: Several model healthcare portfolios, a weekly newsletter, a daily watchlist, and chat for dialogue and questions. Learn more.

Analyst’s Disclosure: I am/we are long MDWD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Comments (30)

Veni Vidi Vici profile picture
@Biologics MDWD announced today that it received a Complete Response Letter from the FDA regarding the BLA for Nexobrid. In addition to CMC issues and the inability of the FDA to complete the required inspections of NexoBrid's manufacturing facilities, the CRL also asked the Company for a safety update as part of a BLA resubmission, and to provide its perspective on the potential impact, if any, on certain observations identified during good clinical practice (GCP) inspections related to MDWD's U.S. Phase 3 DETECT clinical trial.

Did MDWD ever publish the Phase 3 DETECT study results?
no news or surprises in earning(unless i have missed). so wondering why it is down. any thoughts ?
Biologics profile picture
@time1 sector getting pummelled.
Anyone know if there production facility is located in the USA?
@Deeeds Israel and Taiwan.
That sounds like a certain CRL to me
@john boy appears, FDA started doing visits again. latest one they will do in May 2021 is for $SPPI
Veni Vidi Vici profile picture
The most important news from yesterday's earning call was that the FDA has asked MDWD for additional CMC information and that as a result of COVID-19 the agency is unlikely to be able to inspect MDWD's manufacturing facilities in Israel and Taiwan prior to the 6/29/20 PDUFA date.
CEO profile picture
@Veni Vidi Vici delay can be several months...
EscharEx has significant potential. I listened to their presentation and they estimate the TAM to be $2B which MDWD believes they can capture 20%.
@bdymndsoul . I sure hope they hire a CFO that can guide the process or they'll never make money.
Shankley profile picture
MDWD SP is severely under valued currently by any metric used.
Great article, as previously noted. Only areas of disagreement involve the shorter term notions of approval being baked in and technicals being neutral.
I'm not a technical analyst, and don't want to be! But MDWD peaked at $6.07 on Feb 5th, and bottomed at $4.30 on April 23rd. If a 30% drop is neutral...
Just feels like classic "shaking of the tree" has been taking place. And my guess is that those who picked up all the low-hanging fruit are targeting something much higher than current levels before "sell on the news" kicks in.
Love your long-term outlook, though. And I'll be THRILLED if those tree-shakers dump it at $6, and then run it right back down to the $4s again!
More free apples for that trip down the yellow brick road!
@thedoc5350 How low can they drive us this time by your technicals?
CEO profile picture
Nexobrid good for BARDA stockpiles but not an FDA approval?...
Frank Thomas in Florida profile picture
If NexoBrid is such a lifesaving product, and has such superior benefits to the other burn treatments on the market, why not triple or quadruple the price? If I were a burn victim, I would gladly pay more for NexoBrid. I'm sure other burn victims and insurers would as well. If MediWound doesn't raise the price, then I don't see how the Company can make much of a return on its investment given the small size of the addressable market.
Frank Thomas in Florida profile picture
Mediwound has an excellent product line and robust pipeline. At some point, when I don't know, I believe a larger pharmaceutical company eventually buys mediwound out at a significant premium
MikeFromNZ profile picture
Where is NexoBrid being manufactured?
The market may be 200 mil. but if they sell 100 mil. how much would said company recieve with their partnership with vcel
Great way to approach and analyze the investment opportunities in this company. I'm curious what price points the author has set for triggering buys or sales. Thanks
matttrakker profile picture
I used my monster vcel gains 400% (I sold at 20 who knew?) to buy mdxg which is now also up 400% trimmed there to buy mdwd getting ready for the run!
Eric Bradley profile picture
@matttrakker just luck on my part, but I had a meniscus tear from running, and while researching treatment, discovered VCEL. Bought at $4. Could never have guessed the potential gains.
@Eric Bradley Did you get treated with Vericel technology?
Eric Bradley profile picture
No, I did not. In my case, about 40% of my meniscus was cut out in the middle. It ended the pain, but also ended my long-distance running. :-(

As far as I can understand, MACI doesn't treat meniscus.
I do agree with the author the FDA approval is pretty baked into the price and in the mind of the investors. Therefore the catalyst FDA event serves merely an affirmation event without surprise. Thus, coupled with its small moat for the product may not drive up the price. Worse, investors will start having concerns of for the marketing skill and the inevitable secondary offering sure to come shortly. There have been already numerous examples of secondary offerings immediately following positive news among many small promising biotechs so far.
Any upside based on the anticipated FDA approval will be limited, if at all. The risk rests actually in its downward move.
Author’s cautious comments on the short term is right on the mark.
RS1409 profile picture
@Rhmassing the $200 million TAM doesn’t seem like a lot for a company worth ~100 million. It doesn’t seem like there’s much to grow. Am I mistaken?
Great article. And certainly a well thought out trading strategy.
My far less sophisticated plan on MDWD has been to (a) accumulate it for 2 years now, taking advantage of periods where it mysteriously traded like garbage; (b) sit on the unrealized gain; and (c) hold my nose right through NexoBrid AND EscharEx. The latter product, in my opinion, is where the multi-bagger potential lies.
As you noted, management has consistently delivered. And the $125mm market cap represents the best "option value" I've seen in this space since VCEL, not long ago.
Thanks for your work!
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