GERMANTOWN, Md., May 13 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced financial and operational results for the quarter ended March 31, 2008.
MiddleBrook reported first quarter 2008 revenue of $2.4 million, compared to revenue of $2.9 million in the fourth quarter of 2007 and $1.8 million in the first quarter of 2007. The Company reported research and development (R&D) expenses in the first quarter of $3.7 million, compared to fourth quarter 2007 R&D expenses of $3.5 million and first quarter 2007 R&D expenses of $7.5 million. Total operating expenses for the first quarter of 2008 were $9.1 million, down from $9.8 million in the fourth quarter of 2007 and $15.5 million in the first quarter of 2007.
Net loss was $13.8 million for the first quarter, compared to a net loss of $9.1 million in the fourth quarter of 2007 and a net loss of $13.7 million in the first quarter of 2007. The Company recorded a $7.4 million noncash warrant expense in the first quarter of 2008 resulting from the change in the contractual fair value of outstanding warrants which were marked to market as of quarter-end. The Company incurred a $2.1 million noncash warrant expense in the fourth quarter of 2007; however, there were no such expenses in prior periods.
Net loss per share applicable to common stockholders during the first quarter of 2008 was ($0.26), compared to a net loss per share of ($0.19) in the prior quarter, and a net loss per share of ($0.38) in the comparable quarter of last year.
"Since receiving FDA approval for MOXATAG in January, we have been working closely with our contract manufacturer preparing for a potential commercial launch of MOXATAG by as early as the fourth quarter," stated Edward M. Rudnic, Ph.D., president and CEO of MiddleBrook. "Also, we intend to conclude our ongoing strategic process over the coming months."
OPERATIONAL HIGHLIGHTS
Keflex(R) Capsules (Cephalexin, USP) - Commercialization Update
During the first quarter, MiddleBrook continued the commercialization of its 750 mg strength Keflex capsules through a targeted and dedicated national contract sales force. Based on prescription data from IMS Health, total prescriptions filled for Keflex 750 mg capsules in the first quarter of 2008 were 68,064 prescriptions, compared to fourth quarter 2007 prescriptions of 79,628.
MiddleBrook is currently marketing Keflex 750 mg capsules through its sales force of approximately 30 contract sales representatives and three MiddleBrook district sales managers.
MOXATAG(TM) (amoxicillin extended-release) Tablets Approval - January 23, 2008
On January 23, 2008, MiddleBrook received U.S. Food and Drug Administration (FDA) approval of the Company's New Drug Application (NDA) for its once-daily amoxicillin PULSYS(R) product, under the trade name, MOXATAG(TM) (amoxicillin extended-release) Tablets. MOXATAG is approved for the treatment of pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (strep throat) in adults and pediatric patients 12 years or older.
During the first quarter, MiddleBrook was actively engaged in the commercial manufacture, testing and validation of its MOXATAG scaled-up tablet production process in cooperation with its contract manufacturer, STADA Production in Clonmel, Ireland. The Company believes it will be prepared for a potential commercial launch of MOXATAG during the fourth quarter of 2008, pending the outcome of its ongoing strategic evaluation.
MOXATAG is the first and only once-daily aminopenicillin therapy approved by the FDA to treat strep throat. Physicians prescribing MOXATAG would be able to provide their patients the convenience of once-daily dosing while utilizing approximately one-half the amount of amoxicillin currently used. According to prescription data from IMS Health, more than 30 million prescriptions were written for strep throat, pharyngitis and tonsillitis in the U.S. in 2007.
Equity Financing in January 2008 Raises $21 Million in Gross Proceeds
On January 28, 2008, MiddleBrook closed a private placement of common stock and warrants to institutional investors, resulting in the receipt of approximately $19.9 million in net proceeds. The transaction included the private placement of 8.75 million shares of MiddleBrook common stock and five-year warrants to purchase an additional 3.5 million shares of common stock.
The Company intends to use the proceeds from the financing to support the manufacture of MOXATAG, and for working capital and general corporate purposes. In addition, the financing is designed to provide the Company with additional financial flexibility in its ongoing strategic discussions.
Process to Explore Strategic Alternatives Ongoing
In February 2008, MiddleBrook announced that it engaged Morgan Stanley as its strategic advisor in the Company's ongoing strategic evaluation process. MiddleBrook is evaluating a full range of available strategic alternatives intended to further enhance shareholder value.
Strategic alternatives the Company may pursue could include, but are not limited to, continued execution of the Company's operating plan, the sale of some or all of the Company's assets, partnering or other collaboration agreements, or a merger or other strategic transaction. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. The Company does not intend to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed.
FINANCIAL GUIDANCE
MiddleBrook's financial guidance remains unchanged from prior forecasts. Total revenue for 2008 is expected to be approximately $10 million to $12 million, resulting from Keflex product sales and assuming no generic competition to Keflex 750 mg capsules occurs during the year. Total cash used in operating activities and capital expenditures in 2008 is estimated to be between $17 and $19 million. These forecasts also assume no financial impact from the Company's recently approved MOXATAG product, pending the outcome of its ongoing strategic process.
Assuming the Company's expectations for continued sales of its Keflex 750 mg product and anticipated level of R&D spending and other obligations, MiddleBrook believes that its current funds, together with expected Keflex product sales, will be sufficient to support its currently planned operations into 2009. These 2008 estimates are forward-looking statements that involve risks and uncertainties, and actual results could vary materially.
ABOUT MIDDLEBROOK PHARMACEUTICALS:
MiddleBrook Pharmaceuticals, Inc. is a pharmaceutical company focused on the development and commercialization of anti-infective drug products that fulfill substantial unmet medical needs in the treatment of infectious disease. The Company is developing anti-infective drugs based on its novel biological finding that bacteria exposed to antibiotics in front-loaded staccato bursts, or "pulses," are killed more efficiently and effectively than those under standard treatment regimens. Based on this finding, MiddleBrook has developed a proprietary, once-a-day pulsatile delivery technology called PULSYS(R). The Company currently markets the Keflex(R) brand of cephalexin and has received regulatory approval for MOXATAG(TM) -- the first and only once-daily amoxicillin product approved for marketing in the U.S. For more on MiddleBrook, please visit http://www.middlebrookpharma.com.
ABOUT MOXATAG:
MOXATAG(TM) (amoxicillin extended-release) Tablets are a once-a-day extended-release formulation of amoxicillin for oral administration consisting of three components: one immediate-release and two delayed-release. The three components are combined in a specific ratio to prolong the release of amoxicillin from MOXATAG compared to immediate-release amoxicillin. MOXATAG is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis.
ABOUT KEFLEX:
Keflex(R) (cephalexin capsules, USP) is a first-generation cephalosporin antibiotic shown to be active against strains of both gram-positive and gram-negative aerobes in vitro and in clinical infections. Keflex is indicated for treatment of the following infections: respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. More information on Keflex and prescribing information are available at http://www.middlebrookpharma.com/products_antibiotics/keflex_antibiotics.aspx.
This announcement contains historical financial information as of and for three-month period ended March 31, 2008 that is unaudited, and MiddleBrook assumes no obligation to update this information based on new information or future performance except as may be specifically required by applicable law or regulation. The unaudited annual financial information is subject to audit by independent accountants on an annual basis following the close of each calendar year.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on MiddleBrook's current expectations and assumptions. These statements are not guarantees of future performance and are subject to a number of risks and uncertainties that would cause actual results to differ materially from those anticipated. The words, "believe," "expect," "intend," "anticipate," and variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Statements in this announcement that are forward-looking include, but are not limited to, statements about the Company's product development and commercialization schedule, including, particularly, future plans with respect to its Amoxicillin PULSYS products; any statements regarding Dr. Rudnic's comments and expectations concerning the Company; the Company's initiatives to develop improved antibiotics; the Company's existing and anticipated collaborative agreements; and any financial forecasts and projections for 2008 and thereafter included under the Financial Guidance section of this announcement.
The actual results realized by MiddleBrook could differ materially from these forward-looking statements, depending in particular upon the risks and uncertainties described in the Company's filings with the Securities and Exchange Commission. These include, without limitation, risks and uncertainties relating to the Company's financial results and the ability of the Company to (1) raise additional capital and continue as a going concern, (2) maintain its Keflex 750 sales, (3) retain marketing approval for its MOXATAG product, (4) successfully reduce costs, (5) reach profitability, (6) prove that the preliminary findings for its product candidates are valid, (7) receive required regulatory approvals, (8) successfully conduct clinical trials in a timely manner, (9) establish its competitive position for its products, (10) develop and commercialize products that are superior to existing or newly developed competitor products, (11) develop products without any defects, (12) have sufficient capital resources to fund its operations, (13) protect its intellectual property rights and patents, (14) implement its sales and marketing strategy, (15) successfully attract and retain collaborative partners, (16) successfully commercialize and gain market acceptance for its Keflex products, (17) successfully obtain sufficient manufactured quantities of its drug products at acceptable rates, and (18) retain its senior management and other personnel. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. MiddleBrook undertakes no obligation to update or revise the information in this announcement, whether as a result of new information, future events or circumstances or otherwise.
CONTACT: Robert Low, Vice President, Finance & CFO, +1-301-944-6690,
rlow@middlebrookpharma.com, or Bob Bannon, Vice President, Investor
Relations, +1-301-944-6710, rbannon@middlebrookpharma.com, both of
MiddleBrook Pharmaceuticals, Inc.
Web site: http://www.middlebrookpharma.com/
