Highlights of second Seeking Alpha article, from Andy Batts
Insmed: Upcoming Catalysts
ARIKACE successfully met the primary endpoint in a Phase III trial in CF patients with Pseudomonas lung infections in Europe. The FDA designated ARIKACE as a Qualified Infectious Disease Product (QIDP) for the treatment of NTM lung infections. Additionally, the FDA granted Fast Track designation to ARIKACE for the treatment of NTM, which means it will have an accelerated approval time with the goal review time of only 60 days.
Insmed's near-term catalysts:
Europe: ARIKACE Phase III trial to treat CF patients with Pseudomonas lung infections enrollment completed. Top line data reported in July, 2013.
US: ARIKACE Phase II trial to treat NTM enrollment well underway. Top line data expected by year end 2013.
Summary: Reasons to Buy
The once-daily dosing of ARIKACE in CF is its greatest advantage over TOBI, particularly for older people that live on their own.
European Phase III trial showed that ARIKACE is at least equally competitive with TOBI in treating CF with Pseudomonas aeruginosa.
The FDA designated ARIKACE as QIDP for NTM, which will help the company to raise further capital easily for funding future trials.
ARIKACE received Fast Track designation from the FDA for treating NTM, which has increased the probability of getting final approval.
Independent clinical trials show that Insmed's Liposomal Technology with nebulized delivery system is a feasible alternative for CF patients that can't tolerate tobramycin dry powder formulation.
There exists a strong barrier to entry in respiratory medicine business, as huge capital and time are needed to conduct clinical trials.
Despite the tremendous growth prospects of ARIKACE, Insmed is available at a dirt cheap valuation in terms of a Price to Book of only ~3x.
Insmed's shares are expected to get rock-solid support around the current level, as the latest public offering was done at this level. This could be an excellent entry point for medium-term investors.
Going forward Insmed shareholders could see significant share dilution due to frequent public offerings by the company for raising capital.
If ARIKACE doesn't get final regulatory approvals due to technical reasons, Insmed may find it difficult to stay afloat.
In March, the FDA approved a new inhaler delivery system for TOBI. If the efficacy of ARIKACE versus TOBI for treating CF doesn't improve in terms of statistical significance in future trials, Insmed's shares may suffer temporary setbacks going ahead.
Early stage biotech companies most often don't succeed after burning huge cash due to poor teamwork. Insmed has an excellent team working for an ambitious project in respiratory medicine. Over the past nine months Insmed has built its team by adding talented professionals across the company. I strongly believe that the company will live up to the expectations.
Source: Insmed: A Respiratory Medicine Stock With Upcoming Catalysts