Insmed Inc (INSM)

[coinstarz]

Speculation on iPlex..........

First and foremost, please read my Disclaimer Statement at the bottom of this post

I made a phone call to 1-866-GO-IPLEX after the market close to confirm the morning call I received from someone. I trust my source, but I still want to check it out myself. It’s a toll-free number and doesn’t cost me anything. I was glad I did. It was a pleasant to speak a real iPlex sales person. I was told that iPlex will be shipped on this Thursday through a pharmaceutical distributor. The distributor is located in Mid-Atlantic. Insmed has four major call centers that cover entire country. There are 20+/- sales/field person plus 4 executive patients account managers, or called flexpoint. It was designed as a single contact point. Doctor just makes one phone call to the center and Insmed sales people takes care of the rest. They will help patients to fill out the necessary paper work and file to insurance for reimbursement and arrange delivering schedule and other things. I asked the official launching date, but I didn’t get any answer. The Thursday May 18 is a shipping date not launch date per the sales rep.

Then here comes my speculations on launching date and many other things related to iPlex. Again, please read my Disclaimer Statement at the bottom of this post before the continuation.

Now. My speculation begins…

Speculation on iPlex Launching Date

The official launch could be on Thursday May 18, Friday May 19 or Monday May 22. The launch event is a few weeks ahead of external schedule (June 12th) but is a little late (several weeks) behind internal schedule. There were a few issues related to bottling and labeling with 3rd party manufacturing contractors. They delayed launch for more than a month! However, the Insmed management has anticipated this delay due to the delicated making process. They are work extremely hard and to ensure the launch is 100% successful. I am happy that they didn’t provide exact launch date because the bottling and labeling processes were not in the hand of Insmed mgt. Still, they don’t provide any PR or hint through their own IR firm. I believe they want to see iPlex in the patient’s hand and then call for launch. And I must emphasize one more time that the sales rep I talked to didn’t provide any launching date or clue.
http://events.cobioscience.com/index.cfm?action=event&eventid=90

Speculation on iPlex Patients Number

The first batch (5000 vials) has been booked/sold out already. From go-iplex.com, IPLEX™ (mecasermin rinfabate [rDNA origin] injection) is supplied as a 36 mg/0.6 mL preservative-free sterile solution in single dose glass vials. Each box contains 35 vials. IPLEX™ can be stored frozen up to two months at constant temperature (-20°C, -4°F). Taking 5000 and divide it by 35, we get 142 boxes of iPlex vials. The company send a patient one box only. So I assume there are about 100+ patients have prescribed iPlex now. Also, three more batches are bottling and labeling, therefore I guess there could be 200-300 patients for this Q and next. Off-label use is possible. But I doubt that Insmed has 300 patients during the launch. I hope Insmed will have 1000 patients by the end of this year.

Speculation on Distribution Partner

The distribution partner is responsible for packaging, labeling, and shipping. I guess this partner is one of top 3 healthcare provider/specialist with frozen-required product handling and substance-controlled packaging capability. We don’t need to know their names as long as they do the work.

Speculation on Marketing Partner

Pfizer if any.

Speculation on EU EMEA Submission

In 3Q 2006. Mr. Young confirmed the submission at R&R conference. They are putting data (from PSA meeting) together and may submit to EU in August. However, the company said in September, 2006.

Speculation on IPlex Pricing

Increlex is selling for $23,000 per patient per year. I think iPlex will be priced around 26,000 or higher due to the cost of materials and processing.

Speculation on Buyout

Buyout in 2012. The company will be sold for 20+/- in 2012 when they have FDA approval for MMD and Insulin resistance. .

Speculation on Patent Litigation

No results until Spring 2008. Insmed will win. I hope abharploonta will cover this subject.

Speculation on 2nd iPlex generation

Insmed’s ITP is working with DowPharam using its pfenex to make liquid form iPlex. The product will be available in early 2007. FDA submission will be happened in 3Q this year.

Speculation on Institution Holdings (IH)

According to recent SEC filings and NASDAQ website, IH has approx 20% of O/S. Insiders have about 3%. IH could be increased to 30-40% when the PPS hits 3.

Speculation on Convertible Debts (CD)

Based on the latest 10Q and 8-Ks, there is about $2M CD left or 1.2 M +/- shares that may be converted to the common, and I think all those leftovers might have been already converted in the past few weeks.

Speculation on Price-Per-Share (PPS)

Since we cannot control the share price, I leave this speculation to a market maker. Buy-and-hold strategy will be rewarded in 2010.

Speculation on the future of INSM

I firmly believe iPlex will control 70-85% of U.S. market shares (6,000 patients) by the end of 2007, and 60-80% EU shares in 2008. 7-yr orphan protection will make iPlex a wonder drug in the world. The iPlex products are in high demand. ITP works 24/7 to increase production. If you have a chance to go to Insmed HQ or ITP boulder, Co, you will see. $2-$3 Billion market cap by 2010.

All is well.

Disclaimer: The content of this post is my personal opinion only. The purpose of this post is to stimulate and entertain sophisticated market professionals with my researches, judgments, and opinions based on highly controversial and unproven hearsay to attempt to forecast the inherently unknowable future course of iPlex markets. Individual Insmed investor shall be responsible for diligently researching and judging for him/herself all the many factors that can significantly impact his INSM position. Nothing in this post must ever be construed as a solicitation or recommendation to buy or sell INSM security, an act that involves risks of substantial financial loss. Don’t trade INSM security, period!