$MYL pipeline candidate is an epinephrine pre-fil
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Posted On: 05/05/2017 2:53:23 PM
$MYL pipeline candidate is an epinephrine pre-filled syringe for the emergency treatment of anaphylaxis (mainly food allergies and bee stings). This is designed as an alternative to Mylan’s (NYSE:MYL) EpiPen which spent most of 2016 dealing with a pricing fiasco that grabbed national headlines. This is an approximate $1.1 billion market and competitors to the EpiPen have made some recent headway and now account for some 30% of the market.
The stock sold for north of $10.00 a share before its New Drug Application (NDA) was hit with a complete response letter (CRL) from the FDA last summer. Adamis has addressed the manufacturing concerns within that request and resubmitted the NDA in mid-January. I expect the application to be approved this time around and this product to garner $50 million to $100 million in annual sales over time. Not a big part of the overall market, but certainly significant to a company the size of Adamis.
The last part of Adamis’ business is a couple of mid-stage inhalers the company is currently developing. The market is assigning no value to this piece of the business at all, so this is just a “free call option” that investors are picking up for nothing right now.
The stock sold for north of $10.00 a share before its New Drug Application (NDA) was hit with a complete response letter (CRL) from the FDA last summer. Adamis has addressed the manufacturing concerns within that request and resubmitted the NDA in mid-January. I expect the application to be approved this time around and this product to garner $50 million to $100 million in annual sales over time. Not a big part of the overall market, but certainly significant to a company the size of Adamis.
The last part of Adamis’ business is a couple of mid-stage inhalers the company is currently developing. The market is assigning no value to this piece of the business at all, so this is just a “free call option” that investors are picking up for nothing right now.
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