Discovery Labs Updates on 3Q 2013 Financial Results

Discovery Laboratories, Inc. , a specialty biotechnology, announced financial results for the third quarter ended Sept. 30 , as well as recent business updates. In a release on Nov. 12 , the Company said: -Surfaxin: On Oct. 4 , the U.S. Food and Drug Administration agreed to the Company’s updated product specifications for Surfaxin (lucinactant) Intratracheal Suspension. Surfaxin is FDA -approved synthetic, peptide containing surfactant available for the prevention of respiratory distress syndrome in premature infants and the only approved alternative to animal-derived surfactants currently available in the U.S. On Nov. 8 , the Company announced that it has initiated the commercial introduction of Surfaxin in the U.S. -Aerosurf: In October 2013 , the Company submitted an investigational new drug application to the FDA to initiate its Aerosurf phase 2 clinical program. The FDA has completed its review and cleared the IND, and the Company can now proceed with its phase 2 clinical program. Aerosurf is a novel investigational drug-device combination product being developed to deliver the Company’s KL4 surfactant in aerosolized form to premature infants with RDS. Aerosurf could potentially provide neonatologists with the ability to avoid invasive procedures and thereby enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy and currently are not treated. The Company anticipates results from the first phase of its Aerosurf phase 2 clinical program in mid-2014. -Financial Update: As of Sept. 30 , the Company reported cash and cash equivalents of $21.2 million . In November 2013 , the Company completed a public offering of its common stock that resulted in net proceeds, including amounts expected from an over-allotment recently exercised by the underwriters, of approximately $54 million . Additionally, with the initiation of the commercial launch of Surfaxin, the Company became eligible under its secured loan facility with Deerfield Management Co. to receive an additional advance of $20 million , which is expected in early December 2013 . “With the commercial introduction of Surfaxin, initiation of our clinical program for Aerosurf and our strengthened financial position, we are a much stronger company and better positioned to implement our business plan and achieve our vision of advancing a new standard of care for premature infants with RDS,” said John Cooper , President and Chief Executive Officer at Discovery Labs . Summary Financial Results for the Third Quarter Ended Sept. 30 For the quarter ended Sept. 30 , the Company reported a net loss of $12.2 million ( $0.22 basic net loss per share) on 54.8 million weighted-average common shares outstanding, compared to a net loss of $13.3 million ( $0.31 basic net loss per share) on 43.4 million weighted-average common shares outstanding for the same period in 2012. Included in the net loss is the change in fair value of certain common stock warrants that are classified as derivative liabilities, resulting in a non-cash loss of $1.1 million and $3.3 million in 2013 and 2012, respectively. The Company reported an operating loss of $10.8 million for the quarter ended Sept. 30 , compared to an operating loss of $10.0 million for the same period in 2012. Net cash outflows before financing activities for the quarter ended Sept. 30 , were $10.1 million compared to $9.9 million for the same period in 2012. The operating loss for the quarter ended Sept. 30 , includes a $1.3 million investment to prepare for the Aerosurf phase 2 clinical trials. As of Sept. 30 , the Company had cash and cash equivalents of $21.2 million . On Nov. 5 , the Company completed a public offering of 25 million shares of common stock at a price of $2.00 per share, resulting in net proceeds to the Company (after underwriting discount and anticipated expenses) of approximately $46.8 million . The Company also granted the underwriters a 30-day option to purchase up to an additional 3.75 million shares of common stock at an offering price of $2.00 to cover over-allotments, if any. On Nov. 8 , the underwriter notified the Company that it has exercised its over-allotment option to purchase 3.75 million additional shares of common stock. The exercise of the option is expected to close on or about Nov. 14 , and result in net proceeds (after underwriting discount) of approximately $7.1 million . Additionally, with the commercial introduction of Surfaxin, the Company became eligible under its $30 million secured loan facility with Deerfield to receive the final $20 million advance, which is expected on or about Dec. 3 . The initial $10 million was advanced in February 2013 upon execution of the facility agreement. In connection with the $20 million advance, Deerfield will receive a transaction fee equal to 1.5 percent of the advance, and warrants to purchase approximately 4.7 million shares of common stock at an exercise price of $2.81 per share. In October 2013 , the Company initiated an offering under its at- the-market Program with Stifel, Nicolaus & Company, Inc. and issued 713,920 shares of common stock at an average price per share of $2.75 , resulting in net proceeds (after a 3 percent commission) of approximately $1.9 million . Following this offering, approximately $23.1 million remains available under the Company’s ATM Program. For the fourth quarter of 2013, the Company anticipates operating cash outflows before financing activities of $10.5 million , and approximately $85 million in cash and cash equivalents at Dec. 31 . As of Sept. 30 , the Company reported a common stock warrant liability of $4.7 million , predominantly related to five-year warrants issued in February 2011 . These warrants are not subject to cash settlement; however, they have been classified as derivative liabilities in accordance with generally accepted accounting principles because they contain anti-dilution provisions that adjust the exercise price of the warrants in certain circumstances. The Company had 54.9 and 43.7 million shares of common stock outstanding as of Sept. 30 , and Dec. 31, 2012 , respectively. The Company currently has 80.7 million shares of common stock outstanding, not including 3.75 million shares to be issued upon closing of underwriters’ over-allotment option.