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On June 22, Fibrocell (NASDAQ:FCSC) announced that the FDA had approved laVív for smile wrinkles. This was a highly anticipated event as the stock climbed over 120% since the beginning of February. Following the approval, I had the pleasure of speaking with Fibrocell CEO and Chairman David Pernock. My one sentence take on the interview is that the company has a plan and is ready to go with the introduction of laVív into the market.

For some background, laVív is the first and only personalized aesthetic cell therapy approved by the FDA for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. In clinical trials, laVív was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within one week. The patented technology behind laVív is an advanced process that extracts and multiplies a specific kind of a person’s own skin cells (fibroblasts) to create laVív, which is then injected into the patient to improve the appearance of smile lines. In normal skin, fibroblasts are responsible for producing collagen.

Here is what the CEO had to say on the different topics.

laVív - The product is cells that will be shipped in vials. It looks like a clear liquid and the company is using 29 gauge needles for injections. It is easy to inject laVív but it is important for the physician not to go too deep. The company said that 8-10 weeks after injection people start to see peak effect. The indication for laVív is for 6 months but it will ultimately be up to the physician on when to inject the patient. According to a study done by the company, 95% of the people felt the same or better at 12 months versus at six months after injection. Fibrocell is happy with the labeling and it will be available to view on their website shortly.

Manufacturing - The company plans to just use its facility in Pennsylvania for manufacturing laVív. The CEO said that the company has the physical space to expand manufacturing capabilities there and it is very important that the company has the manufacturing facility under close supervision because laVív is a custom therapy that requires a rigorous and meticulous process for manufacturing. The company will have enough capacity to supply all of the United States just from that facility. Mr. Pernock said building out the facility should be fairly easy because all the company has to do is add equipment to their facility.

Product Rollout - Fibrocell is ready to go with the rollout of laVív in a few weeks with a core group of 30 or so clinical investigators. Management does expect some supply constraints in the beginning. The company expects to have a small sales staff in the early days but expects to add staff throughout the year. The sales staff will be focused on high volume marketplaces. Mr. Pernock also added that management is focused on having impeccable customer service to develop customer relationships over the long-term.

Sales Forecast – The company would not give a detailed forecast but said that sales for laVív will start in July and will be slow and steady. Sales should get more in full swing as the year progresses. The company said sales in the first 6 months will be small but expects to reach the critical masses in January 2012.

Raising Capital - Mr. Pernock admitted that despite having some cash in the bank, Fibrocell will need to raise more capital. It is currently in the process of developing a plan for more capital.

Marketing - The cell therapy company cannot afford to do big direct to consumer advertising and it will rely on public relations in their target markets. The CEO noted that beauty magazines lead to good press. The company is going to target a number of cities in the country. The plan is to focus on Southern California, South Florida, Chicago, Dallas and a couple of cities on the eastern seaborne.

Market Potential - There are 1,200 dermatologists the company is targeting. These 1200 do a great majority of dermatology business in the United States. In the target market, there were 4.5 million procedures last year and it amounted to $11 billion.

Other Indications - The company is excited about the laVív platform after approval for the first indication. Fibrocell thinks it will be easy to extend the laVív platform into other indications as the way to produce the sales is exactly the same. The CEO noted that laVív can be easily developed for other indications such as small lines and wrinkles around lips and eyes, acne scars, and burn scars. The CEO added that there is a very "substantial" opportunity in these markets as there is no competition in these areas. The company already has some promising data on burn scars and is in the process of setting up a meeting with the FDA on its trials of laVív for acne scars.

Pricing - Fibrocell will disclose pricing for laVív in a few weeks but it is going to be consistent with the strategy of having a long-term relationship with the customer and will be in-line with the price basket of aesthetic treatments.

Source: Fibrocell: laVív Sales to Reach Critical Masses in 2012, CEO Says