I have been long this one for 3 years and believed it to be DOA. A few events over the last 6 months have caused me to reconsider:
1) A new management team was installed at year-end
2) 2 recent private placements have given CRMD some much-needed breathing room.
3) Yesterday's 8-K (see below)
The 8-K release likely has more importance than many realize. The company has been on an endless quest to obtain a CE mark in Europe to begin selling its catheter lock product. I believe yesterday's 8-K translates into "they are very close" since the clinical aspect is a go. Essentially, I think it boils down to CRMD needing to create acceptable packaging and regulatory approval will be granted.
CRMD seems to be laying plans for a Euro launch. They have hired Joachim Petrak(the guy who led the German launch of Renagel (Sevelamer)) as sales manager in Europe. Very smart move to hire a local. (see below)
Downside here is balance sheet is very, very thin and they will need to raise $$$ this year. Upside is that current market cap is miniscule.
Additional Considerations: IP issue here could provide upside re: TauroPharm ( a German competitor) See CRMD S-1 for details.
Long and Hopeful Here
Other Events, Change in Directors or Principal Officers
Item 8.01. Other Events.
On March 5, 2013, T&V-S&D, the European notified body managing the CE Mark application for our product candidate CRMD003, or Neutrolin&, informed us that the Medicinal Evaluation Board of the Netherlands, or MEB, gave us a positive response on the clinical aspect of our application. The MEB is responsible for authorizing and monitoring safe and effective medicinal products on the Dutch market and shares responsibility for authorizing medicinal products throughout the European Union.
We are now working on the final packaging for Neutrolin with internationally recognized consultants and a leading packaging systems company to meet T&V-S&D requirements. As a result, we anticipate final approval for the CE Mark certification for Neutrolin during the second quarter in 2013.
Additionally, to lead the commercialization of Neutrolin in the European Union, we have formed a European subsidiary, CorMedix Europe GmbH.
Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
(e) On March 6, 2013, our Board of Directors approved an amendment to the vesting schedule of the options granted to our directors and executive officers on December 5, 2012. Such options are described further in our Current Report on Form 8-K filed with the SEC on December 7, 2012. Given the anticipated final approval for the CE Mark certification for Neutrolin during the first half of 2013, such options will now vest as follows: (a) fifty percent (50%) on the date of issuance of the CE Mark certification for Neutrolin in Europe, if the CE Mark approval is obtained on or before June 30, 2013 (as opposed to March 31, 2013 as previously provided by our Board), and (b) fifty percent (50%) on December 31, 2013.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it has signed a commercial agreement with MKM Co-Pharma GmbH (http://mkm-europe.com/en/), a European sales, marketing and advertising company with extensive experience in the launch of cardiorenal products. CorMedix entered into this agreement while awaiting the outcome of its application in the European Union (NYSEARCA:EU) for a CE mark for Neutrolin®, a catheter lock solution (NYSE:CLS). If approved for use in the EU, Neutrolin will be used for the prevention of catheter related bloodstream infection (CRBI) and maintenance of catheter patency in hemodialysis (NYSE:HD) patients.
To help prepare for a successful launch of the Neutrolin solution, which is planned initially in Germany, MKM hired as a national sales manager Joachim Petrak, who led the German and Central European launch of Renagel (sevelamer), a phosphate binder used to control phosphorus levels in people with chronic kidney disease who are on dialysis. Mr. Petrak has extensive experience with therapeutics (devices and drugs) in the renal dialysis market and strong relationships with European key opinion leaders (KOLs) in this segment.
"We believe our new relationship with MKM, including the addition of Joachim Petrak, will help drive successful sales and marketing efforts for the Neutrolin catheter lock solution in Germany at first, and later in the European Union, in anticipation of product approval," said Randy D. Milby, CorMedix Chief Executive Officer. "Together, we will aim to ensure that Neutrolin becomes widely available in Europe for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease."
"These activities reflect the recent business and management progress we've made at CorMedix," Milby added. "After obtaining the CE mark, we plan to further our efforts for a U.S. FDA regulatory program for Neutrolin and to advance our company and pipeline programs."
Recently, CorMedix reorganized the company bringing in a new management team to enhance its transformation into a commercial organization. Pharmaceutical industry executive Randy Milby was named Chief Executive Officer of CorMedix, supported by Richard Cohen, Chief Financial Officer, and Arthur Morelli, Vice President of Commercial Operations. Morelli brings 30 years of pharmaceutical experience at Du Pont Pharma, Du Pont Merck Pharma, Cardinal Health, Elan Biopharmaceuticals and Solstice Neurosciences. Throughout his career, Morelli has held positions from sales representative to Executive Vice President of Commercial Operations. The new management is focused on efficient execution, and will be the key link between CorMedix's operations in Germany and its Bridgewater, NJ headquarters.
Antony E. Pfaffle, M.D., a CorMedix founder and Chief Scientific Officer, remarked, "The test of a great new product is whether it can raise the standard of care for patients. We believe that, if approved, Neutrolin will reduce potentially life-threatening infections and prevent catheter loss. We are pleased to have achieved this important milestone that we believe will strengthen our ability to launch Neutrolin, once approved in the EU."