Question for experienced MNKD longs ONLY, no bashers, no shortie boys!
This is the first biotech stock I have purchased so I have a few questions that I need someone to clear up for me and tell me if I am missing something. What does MNKD accomplish by announcing a partner before FDA accepts the submission of the NDA? Do they have to announce a partnership if it is contingent upon FDA approval(which we know it will be)?.....I understand the need to get to work, but why not wait until after the NDA is accepted? I see a separate announcement giving more bang for your buck and what it will do to the stock price....more free publicity, too....Keep them talking about Mannkind and Afrezza. With the DC nonsense, I would definitely think it beneficial to wait a bit. Let everything cool down in the market. If those DC turkeys default on the debt, who knows where any of us may be in a few weeks.......If I were Al, I wouldn't let DC steal my thunder...He has waited for this moment, along with approval and I just don't see him announcing anything in this type of political environment right now...and with the Wall Street nerves now. I still think it is Sanofi and maybe others. I don't know. Why would MNKD be hiring in Danbury now if they were not preparing for something? . Would Al still make preparation in Danbury if selling was his objective? Sorry to ask these questions, but those are the things I ask myself.
Q1:What does MNKD accomplish by announcing a partner before FDA accepts the submission of the NDA?
MNKD did not male any statement about partnership before FDA accepts NDA submission. MNKD said 4Q 2013 would be ideal. This is because it takes anywhere from 6 - 12 months of preparation to launch a product. This includes hiring hundreds of people, advertising and promotion, scheduling visits to doctors, getting product out to the distribution channels (e.g. pharmacy), and getting approved by insurance plans including government plans. Maintaining a fully staffed manufacturing facility for 6 to 12 months without selling anything is costly, not to mention the lost sales of anywhere between $100M-$500M. We are in 4Q, so anytime now would be ideal to announce partnership.
Q2:Why would MNKD be hiring in Danbury now if they were not preparing for something? . Would Al still make preparation in Danbury if selling was his objective? The FDA has to inspect the manufacturing facility actually working. So full staffing is necessary for the inspection. Full staffing for full production is necessary whether MNKD is planning on partnership or outright sale. Outright sale does not mean they collect their money and leave. Outright sale could mean just being bought out but continuing as a subsidiary of a larger pharma with everything else being the same including Al retaining his CEO position. This is very common in the pharma industry because of the uniqueness of the drugs and production processes. So it is possible that selling or partnership can happen. Either way, they have to be fully staffed and ready to roll out the product to market.
mann ontop, I forgot to mention that patent life is also very valuable to branded products. A blockbuster drug with at least $1B annual sales would lose $1B every year a patent life runs without launching the product. Imagine if Afrezza was a $2B-$3B a year product. For want of hiring people that would cost anywhere from $100M to $300M/year, you lose $2B-$3B. This is why time is of the essence. The buyer of MNKD will count the total productive patent life and deduct any lost time.