- Total net revenues increased 35% to $6.7 million in the third quarter of 2012, compared to $4.9 million in the third quarter of 2011.
- Net product revenues were $5.6 million, compared to $4.1 million in the third quarter of 2011, due to higher sales of CRINONE ® (progesterone gel) to Merck Serono S.A. (“Merck Serono”) and Watson Pharmaceuticals, Inc. (NYSE:WPI)(“Watson”).
- Gross profit on net product revenues was 43%, compared to 24% in the third quarter of 2011, due primarily to greater sales in higher-margin country markets.
- Operating income was $1.4 million, versus an operating loss of $0.6 million in the third quarter of 2011, reflecting the higher revenues and a $0.4 million decrease in operating expenses from prior year levels.
- Cash, cash equivalents and short-term investments increased by $2.6 million in the quarter to $25.6 million at September 30, 2012.
Total net revenues for the third quarter of 2012 were $6.7 million, compared to $4.9 million for the third quarter of 2011. The increase in total net revenues was driven primarily by a $1.5 million increase in net product revenues and, to a lesser extent, higher royalty revenues.
- Net product revenues increased to $5.6 million in the third quarter of 2012 as compared to $4.1 million in the third quarter of 2011, primarily due to higher sales to Merck Serono and Watson.
- Total royalty revenues were $1.0 million in the third quarter of 2012, compared to $0.8 million in the third quarter of 2011, primarily reflecting royalty revenues from Watson on CRINONE products.
- There were essentially no other revenues in the third quarter of 2012 or 2011.
Operating income was $1.4 million in the third quarter of 2012, compared to an operating loss of $0.6 million in the prior year period. The change primarily reflects the $1.5 million increase in net product revenues and $0.2 million increase in royalty revenues, coupled with the $0.4 million decrease in operating expenses, in the third quarter of 2012.Other income and expense aggregated to a net loss of $1.0 million for the third quarter of 2012, compared to net income of $5.0 million in the third quarter of 2011, primarily reflecting the recognition of the $1.1 million change in the fair value of the warrants issued in conjunction with the October 2009 stock issuance resulting from the increase in Columbia's stock price from June 30, 2012 to September 30, 2012. As a result, the Company reported net income of $0.4 million, or $0.00 per basic and diluted share, compared to net income of $4.4 million, or $0.05 per basic and $(0.01) per diluted share, for the third quarter of 2011. At September 30, 2012, Columbia had cash, cash equivalents and short-term investments of $25.6 million, compared to cash, cash equivalents and short-term investments of $23.0 million at June 30, 2012, and $25.1 million at December 31, 2011. The Company believes its cash, cash equivalents and short-term investments will sustain its operations for the foreseeable future. On October 26, 2012, it was confirmed that the FDA has denied Watson's Formal Dispute Resolution Request (FDRR) related to its New Drug Application (NDA 22-139) for PROCHIEVE for the prevention of preterm birth in women with a short cervical length. Watson filed its FDRR in August of 2012. Financial Outlook Columbia has streamlined the organization to operate as cash flow neutral-to-positive. The Company is currently evaluating potential strategic transactions to add value for its stockholders. Any significant expenses resulting from pursuing a possible strategic transaction could affect cash flow in the quarters incurred.
Conference CallAs previously announced, Columbia Laboratories will hold a conference call to discuss financial results for the third quarter ended September 30, 2012, as follows:
|Date:||Thursday, November 8, 2012|
|Time:||11:00 am EST|
|Dial-in numbers:||(877) 303-9483 (U.S. & Canada) or (760) 666-3584|
|Live webcast:||www.columbialabs.com, under 'Investor'|
CRINONE ® and PROCHIEVE ® are registered trademarks of Watson Pharmaceuticals, Inc.
|COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30, 2012 (unaudited)||December 31,2011|
|Cash and cash equivalents||$||10,185,582||$||10,114,163|
|Accounts receivable, net||4,866,249||4,695,410|
|Prepaid expenses and other current assets||503,731||667,927|
|Total current assets||34,641,275||34,137,229|
|Property and equipment, net||2,019,996||1,481,071|
|LIABILITIES AND SHAREHOLDER'S EQUITY|
|Series C redeemable shares||550,000||600,000|
|Total current liabilities||5,164,933||7,236,517|
|Common stock warrant liability||2,769,277||8,168,846|
|Preferred stock, $.01 par value; 1,000,000 shares authorized,|
|Series B convertible preferred stock,130 shares issued and outstanding (liquidation preference of $13,000)||1||1|
|Series E convertible preferred stock, 22,740 shares issued and outstanding (liquidation preference of $2,274,000)||227||227|
|Common Stock $.01 par value; 150,000,000 shares authorized; 87,543,781 and 87,367,313 shares issued in 2012 and 2011, respectively||875,437||873,673|
|Capital in excess of par value||278,695,861||278,060,138|
|Less cost of 36,448 treasury shares||(125,381||)||(125,381||)|
|Accumulated other comprehensive income||279,856||104,902|
|TOTAL SHAREHOLDERS' EQUITY||28,729,179||20,630,807|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||36,700,149||$||36,082,586|
|COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)|
|Nine Months EndedSeptember 30,||Three Months EndedSeptember 30,|
|Net product revenues (including amounts from related party:|
|2012 - $3,590,073; 2011 - $1,513,296)||$||16,101,350||$||12,536,141||$||5,620,889||$||4,129,112|
|Royalties (including amounts from related party:|
|2012 - $2,232,397; 2011 - $1,845,154)||2,532,197||2,070,226||1,017,609||782,694|
|Other revenues (including amounts from related party:|
|2012 - $0; 2011 - $21,974,383)||103,568||22,078,785||34,540||34,888|
|Total net revenues||18,737,115||36,685,152||6,673,038||4,946,694|
|COST OF PRODUCT REVENUES|
|Cost of product revenues (including amounts from related party:|
|2012 - $3,263,376; 2011 - $1,453,720)||9,655,624||8,161,210||3,186,792||3,124,284|
|Selling and distribution||—||87,669||—||—|
|General and administrative||6,376,561||6,765,420||1,901,880||1,908,616|
|Research and development (net of reimbursement from related|
|party: 2012 - $435,199; 2011 - $2,690,163)||856,545||2,362,434||143,795||508,884|
|Net gain on U.S. sale of STRIANT||—||(2,533,127)||—||—|
|Total operating expenses||7,233,106||6,682,396||2,045,675||2,417,500|
|Income (loss) from operations||1,848,385||21,841,546||1,440,571||(595,090)|
|OTHER INCOME (EXPENSE):|
|Change in fair value of redeemable warrants||—||(2,721,205)||—||—|
|Change in fair value of stock warrants||5,399,569||2,790,337||(1,065,498)||5,050,520|
|Total other income (expense)||5,442,565||(259,287)||(1,049,500)||5,045,537|
|Income before taxes||7,290,950||21,582,259||391,071||4,450,447|
|Provision for income taxes||(5,018)||(37,710)||(2,342)||(33,206)|
|NET INCOME PER COMMON SHARE:|
|WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:|