Trading FDA, Clinical Trial Binary Events: Cumberland Pharma

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

Shares of Cumberland Pharma (NASDAQ:CPIX) have shed approximately 65% of market value since its initial public offering (IPO) last August at $17 per share.

With shares of this specialty pharmaceutical company focused on the hospital market niche now trading around 6 bucks, a market cap of about $122 million, and an enterprise value of about $63 million ahead of an expected FDA decision later this quarter; investors may want to take a second look at the stock.

Summary of 1Q10 Results and Financials for CPIX...

  • $10.1 million (M) (+7% from year-ago period): $7.7M ACETADOTE, $2.3M KRISTALOSE
  • Total operating expenses of $9.3M vs. $7.3M in year-ago period, increase due to hiring expenses to expand hospital sales force associated with market launch of CALDOLOR (intravenous or IV formulation of the widely used NSAID ibuprofen for treatment of pain and reduction of fever)
  • Net income of $0.3M vs. $1.2M in the year-ago period, lower due to increased sales/marketing expenses and increased number of common stock shares outstanding associated with IPO
  • Weighted average diluted shares outstanding of 21.4M vs. 16.1M in the year-ago period
  • Ended 1Q10 with $73.8M in cash/equivalents and $98.7M in total assets vs. $78.7M and $103.7M, respectively, at year-end 2009
  • Total debt of $15.3M at end of 1Q10 vs. $6.8M of total debt in the year-ago period

Pending FDA decision under priority review...

In May 2010, the FDA officially accepted the Company's supplemental New Drug Application (sNDA) for ACETADOTE (acetylcysteine for injection) and granted a six-month priority review. In addition to potential expanded product labeling, CPIX has requested additional exclusivity for the product. If approved, CPIX expects to begin marketing ACETADOTE for the new indication in 2011.

On 3/30/10, CPIX announced its sNDA filing to expand the FDA-approved product use in patients with non-acetaminophen acute liver failure, and the Agency subsequently accepted the sNDA with a priority (six-month) review designation in May 2010. ACETADOTE is currently used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter (OTC) pain drugs such as TYLENOL. ACETADOTE is the only approved injectable product in the US for the treatment of acetaminophen overdose.

Disclosure: No positions