To the Meat of the Matter: Current interim CorMedix (CRMD) CEO, Randy Milby and his management team (Anthony Pfaffel, M.D. - CSO, Steven Lefkowitz - former interim CFO, etc...) and BOD (lead by current Chair, Cora Tellez, and former Chair, Dr. Gelbfish, etc...) have IMO done a formative job in steering the company through challenging times.
What has Occurred: Since Mr. Milby's arrival at CorMedix, he has seen the company be granted EU approval of Neutrolin as a catheter lock solution in hemodialysis, Neutrolin's EU label expansion, initiate a legal defense of CorMedix's European intellectual property & defend CorMedix against alleged unfair practices in Germany, receive FDA Fast Track designation, be granted GAIN Act QIDP (Qualified Infectious Disease Product) approval and thereby extending Neutrolin's marketing & sales exclusivity to 101/2 years upon Phase 3 approval, receive FDA Phase 3 trial approval for Neutrolin, begin to seek Orphan Drug designation for several pediatric indications (chronic TPN for malabsorption/Severe Combined Immune Deficiency/Common Variable Immune Deficiency), which could add additional extension of marketing & sales exclusivity for those Pediatric conditions beyond the 101/2 years provided for by QIDP, and see Cormedix added to the Russell 3000.
Also, since Mr. Milby's arrival at the company, he has increased CorMedix's balance sheet's cash from just over $850,000 to enough to run Neutrolin's Phase 3 trials, and by some estimates up to $40,000,000. The stock price has increased from $0.29/share to $4.25/share at the close of trading on Friday, July 17, 2015 -- before the announcement of his stepping down as CorMedix's CEO, representing an almost 14x ROI.
In My Opinion: Credit must be given to Mr. Milby's and BOD's decisive decision to seek out a new CEO to carry CorMedix along to the next stage of company development. Mr. Milby has overseen the growth of CorMedix from a virtual clinical-stage microcap biopharmaceutical company, to an emerging commercial-stage, small cap biopharmaceutical company, preparing to enter Phase 3 clinical trials for a potential GREATER than $1Billon US market.
Thank goodness, Mr. Milby and CorMedix's Board recognize a different set of managerial skills and experience is required to oversee the company to it's next stage of development!
CorMedix will not have a challenging time successfully recruiting a new CEO. In my opinion, I believe the company may actually be further along in the executive selection process than most are expecting.
I believe the company will attract a significant slate of qualified executive candidates. I have given considerable thought to potential candidates. For example, I would expect that the CEO candidate would be an experienced professional with a successful track record in overseeing a publicly-traded, emerging life sciences/pharmaceutical company in the anti-infective space, and having successfully managed the oversight of clinical trials and proctoring that company from development to commercialization. In that regard, I did a data base search with certain implied parameters, and identified potential sources of candidates. Of particular interest, would be former executives and management from Cubist Pharamaceuticals -- recently acquired by Merck for $8.4B in cash in January (2015) of this year. In March (2015) of this year, Merck dumped 120 former Cubist employees in Massachusetts, beginning the integration of Cubist into the Merck culture. Perhaps that is enough to stimulate the likes of Michael Bonney or Robert Perez, former Cubist CEOs to cast an eye CorMedix's way?!
Why Not!!: The CorMedix CEO position is a gift on a silver platter...fully funded for Phase 3 trials, CEO already announced stepping aside, Phase 3 trial approval, QIDP & Fast Track approval, anti-infective space, multi-billion dollar potential US, alone, market, Phase 3 slated to begin 4Q:15, 18 months to completion, and VERY LOW equity price for restricted stock options, EverCore Partners & Elliot Management involved, etc...
Where do I sign up!
Disclosure: I am/we are long CRMD.
Additional disclosure: I am long this security, CRMD. This piece was written solely by me and the views and opinions written and expressed in this piece are are solely this author's. I have NOT received any type of compensation for authoring this piece, and I have NO business relationship with any company or stock mentioned in this piece.