Middlebrook Pharmaceuticals announces financial and operational results for third quarter 2009

MiddleBrook Pharmaceuticals, Inc.Nov 5 2009

MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) today announced its financial and operational results for the quarter ended Sept. 30, 2009.

“MOXATAG tripled its share of the oral-solid penicillin-class antibiotic market during the 2009 third quarter,” said MiddleBrook President and CEO John Thievon. “With the height of the strep throat season approaching in the first calendar quarter of 2010, we believe our nationwide sales and marketing campaign will continue to increase awareness of MOXATAG and drive significant market share and prescription growth over the coming months.”

Third Quarter 2009 Financial Results:

MiddleBrook reported third quarter 2009 net revenue of $1.1 million, compared to net revenue of $2.3 million in the third quarter of 2008. Net sales of MOXATAG (extended-release amoxicillin) Tablets, 775 mg, totaled $(0.6) million for the 2009 third quarter and were negatively impacted by a $1.3 million one-time cumulative adjustment related to the July 2009 implementation of the MOXATAG $20 maximum co-pay program. The $1.3 million adjustment applies to MOXATAG inventory sold into the channel before the third quarter of 2009. Net sales for the KEFLEX® (cephalexin, USP) franchise totaled $1.7 million in the third quarter of 2009.

Net loss was $17.0 million for the 2009 third quarter, compared to a net loss of $12.5 million attributable to MiddleBrook in the third quarter of 2008. Net loss per share during the third quarter of 2009 was $0.20, compared to a net loss per share of $0.19 in the prior-year third quarter.

MiddleBrook reported cost of goods sold in the amount of $0.5 million for the 2009 third quarter, compared to $0.3 million in the prior-year period. Research and development (R&D) expense in the third quarter of 2009 was $1.4 million, compared to third quarter 2008 R&D expense of $6.9 million. Selling, general and administrative expense was $16.2 million in the third quarter of 2009, compared to $7.0 million in the prior-year period.

As of Sept. 30, 2009, MiddleBrook’s cash, cash equivalents, and marketable securities totaled $28.4 million, compared to $74.7 million as of Dec. 31, 2008.

Outlook:

MiddleBrook is narrowing its 2009 annual revenue guidance and expense estimate and is providing a total operating expense estimate for 2010. Combined 2009 net sales for MOXATAG and KEFLEX are now expected to range between $16 and $18 million. Total 2009 operating expenses are anticipated to range between $75 and $78 million. MiddleBrook estimates that its total 2010 operating expenses will range between $65 and $70 million. The Company anticipates the need to raise additional capital to fund operations through 2010.

Third Quarter 2009 Conference Call and Webcast

As previously announced, MiddleBrook Pharmaceuticals is releasing its financial and operational results for the third quarter of 2009 today, Thursday, Nov. 5, 2009, before the market opens. At 9:00 a.m. (ET) today, MiddleBrook management will conduct a conference call to review results for the third quarter.

To listen to the call live, dial 1-800-813-8504 or 1-660-422-4526. A replay of the call will be available at approximately 11 a.m. on Nov. 5 through 5 p.m. on Nov. 12, 2009. To listen to the replay, dial 1-800-642-1687 or 1-706-645-9291, and enter the conference ID #36178550.

A live audio webcast of the conference call also will be available by going to the Investor Relations section of MiddleBrook's web site, www.middlebrookpharma.com. A replay of the webcast will be available for approximately one year starting the afternoon of Nov. 6, 2009.

Please note: A slide presentation to accompany the audio webcast of the conference call will be available by going to the Investor Relations section of MiddleBrook’s Web site, www.middlebrookpharma.com.

MiddleBrook Pharmaceuticals Reports Inducement Grants Under NASDAQ Marketplace Rule 4350

MiddleBrook Pharmaceuticals also announced today that on Oct. 30, 2009, it granted options to purchase a total of 30,000 shares of MiddleBrook's common stock to three (3) new employees as a material inducement for them to join MiddleBrook. The options were granted pursuant to NASDAQ Marketplace Rule 4350(i)(1)(A)(iv) and under MiddleBrook's New Hire Stock Incentive Plan, which was approved by MiddleBrook's Board of Directors on Sept. 26, 2008 and further ratified by the Company’s Compensation Committee on August 20, 2009. The options have a per share exercise price equal to the closing price of MiddleBrook's common stock on the NASDAQ Global Market on the business day immediately preceding the grant date, a ten-year term and vesting over four years, with 25 percent of the options vesting one year from the grant date and 1/48th of the options vesting monthly thereafter. The options have a grant date of Oct. 30, 2009.