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MiddleBrook Pharmaceuticals Reports Fourth Quarter
and Full Year 2007 Results
Keflex Product Sales Grow to $10.5 Million in
2007;
MOXATAG, Company's Lead PULSYS Product, Approved Following Year-end;
Process to Explore Strategic Alternatives Ongoing
GERMANTOWN, Md.
March 4
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK),
a pharmaceutical company focused
on developing and commercializing novel anti-infective products,
today announced financial and operational results for the quarter
and fiscal year ended December 31, 2007.
MiddleBrook reported fourth
quarter 2007 revenue of $2.9 million, compared to revenue of $3.1
million in the third quarter of 2007
and $1.2 million in the fourth quarter of 2006. Revenue for the
full year of 2007 increased to $10.5 million, up 117% from revenue
of $4.8 million for the full year of 2006.
MiddleBrook reported
research and development (R&D) expenses
in the fourth quarter of $3.5 million, down from third quarter 2007
R&D expenses of $5.5 million and fourth quarter 2006 R&D
expenses of $6.3 million. For the full year of 2007, R&D expenses
declined to $22.0 million, from $26.0 million in R&D expenses
for the full year of 2006.
Total operating expenses for the fourth
quarter of 2007 were $9.8 million, down from $13.2 million in
the third quarter of 2007 and
$14.9 million in the fourth quarter of 2006. However, total expenses
for the full year of 2007 increased slightly to $50.6 million,
compared to total expenses of $48.2 million in 2006.
Net loss was
$9.1 million for the fourth quarter, compared to a net loss of
$10.1 million in the third quarter of 2007 and a net
loss of $13.8 million in the fourth quarter of 2006. Net loss
for the full year of 2007 was $42.2 million, compared to a net loss
of $42.0 million in the prior year.
Net loss per share applicable
to common stockholders during the fourth quarter of 2007 was ($0.19),
compared to a net loss per share
of ($0.22) in the prior quarter, and a net loss per share of ($0.44)
in the comparable quarter of last year. Net loss per share applicable
to common stockholders during the full year of 2007 was ($0.96),
down from a net loss per share of ($1.38) in the full year of
2006.
"Having received FDA approval for MOXATAG and raising more
than $20 million in the first quarter of 2008, we believe we are
now in a very favorable position to be considering strategic alternatives
for the Company," stated Edward M. Rudnic, Ph.D., president
and CEO of MiddleBrook. "We intend to work closely with Morgan
Stanley over the coming months to drive the strategic process toward
a potential transaction having the greatest benefit for our shareholders."
OPERATIONAL
HIGHLIGHTS
Keflex(R) Capsules (Cephalexin, USP) - Commercialization
Update
During the fourth 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 fourth quarter of 2007 were 79,628 prescriptions, compared
to third quarter 2007 prescriptions of 83,767.
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.
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.
Keflex Transaction Raises $7.5 Million in Gross
Proceeds
As previously announced, MiddleBrook closed an
agreement on November 7, 2007, with Deerfield Management, a healthcare
investment
fund
and one of the Company's largest equity shareholders, raising
$7.5 million in cash through the sale of the Company's non-PULSYS
Keflex
assets, which the Company has the option to repurchase in the
future.
Under the terms of the agreement, the Company
received $7.5 million of gross proceeds, less a $0.5 million payment
to Deerfield.
The
Company has the right to repurchase the assets sold in the transaction
for a total of $11.0 million prior to year-end 2009. Proceeds
from the agreement allowed MiddleBrook to repay in full its outstanding
loan facility with Merrill Lynch and eliminate the associated
interest
and principal payments.
Equity Financing in January 2008 Raises
$21 Million in Gross Proceeds
Subsequent to year-end, MiddleBrook
closed a private placement of common stock and warrants to institutional
investors, resulting
in the receipt of $21.0 million in gross proceeds, less approximately
$1.1 million in transaction expenses. The transaction included the
private placement of 8,750,000 shares of MiddleBrook common stock
and five-year warrants to purchase an additional 3,500,000 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
DETAILS
-- Total revenue, resulting entirely from net Keflex product sales,
was
$2.9 million in the fourth quarter of 2007, compared to revenue
of $3.1
million in the prior quarter, and $1.2 million for the fourth
quarter
of 2006. Revenue during the full year of 2007 was $10.5 million,
up
from revenue of $4.8 million during the full year of 2006. Increased
product sales in 2007 were mainly attributable to the Company's
Keflex
750 mg strength capsules which were launched during the second
half of
2006.
-- Operating expenses. Research and development
expenses, which primarily
consist of salaries, stock-based compensation, and related expenses
for
personnel and the costs the Company's clinical trials and research
initiatives, were $3.5 million in the fourth quarter of 2007, down
from
$5.5 million in the previous quarter and $6.3 million in the fourth
quarter of 2006. R&D expenses declined for the full year of 2007 to
$22.0 million, compared to $26.0 million in the prior year. Reduced
R&D
expenses resulted mainly from lower spending on the Company's MOXATAG
clinical trial which concluded in 2006.
Selling, general and administrative
(SG&A) expenses totaled
$5.6
million in the fourth quarter of 2007, down from $6.5 million in
the
third quarter of 2007, and $8.3 million in the fourth quarter of
2006.
Fourth quarter SG&A costs declined due to lower third-party costs
associated with the reduced size of Company's contract sales force.
For
the full year of 2007, SG&A expenses increased to $26.0 million, from
$21.3 million, as the Company incurred a full year of Keflex 750
selling and marketing expenses in 2007, versus incurring such costs
only during a portion of 2006.
-- Other expenses for the fourth quarter
of 2007 included a $2.1 million
noncash expense for the contractual value of warrants issued to
Deerfield Management pursuant to the Keflex transaction in the
quarter.
There were no such expenses in prior periods.
-- Net loss for the
fourth quarter of 2007 was $9.1 million. This compares
to a net loss of $10.1 million in the third quarter of 2007, and
$13.8
million in the fourth quarter of 2006. Net loss for the full year
of
2007 was $42.2 million, compared to a net loss of $42.0 million
for the
full year of 2006. The net loss for the three months and full year
ended December 31, 2007, was reduced by $0.2 million attributable
to
the loss from noncontrolling interest in two companies affiliated
with
Deerfield Management pursuant to the Keflex transaction, resulting
from
MiddleBrook's consolidation of the two affiliates under Financial
Accounting Standards Board Interpretation No. 46 (revised 2003)
"Consolidation of Variable Interest Entities."
-- Net loss per share
applicable to common stockholders for the fourth
quarter of 2007 was ($0.19), compared to a loss per common share of
($0.22) in the prior quarter and ($0.44) in the fourth quarter of 2006.
For the fiscal year of 2007, net loss per share applicable to common
stockholders was ($0.96), down from ($1.38) for the fiscal year of
2006.
Per share figures were computed on the basis of
an average of 46.7
million shares outstanding in the fourth quarter of 2007, 46.7
million
shares outstanding in the third quarter of 2007, 31.5 million
shares
outstanding in the fourth quarter of 2006; and 43.8 million shares
outstanding for the full year of 2007 and 30.5 million shares
outstanding for the full year of 2006.
-- Cash and marketable securities
decreased by $4.0 million during the
fourth quarter. Changes were composed of $6.9 million of operating
losses, $4.9 million in loan payments, and $2.3 million for working
capital changes and other items; offset by $7.0 million raised
from the
Deerfield Management Keflex transaction and $3.1 million for
non-cash
expenses.
-- The Balance Sheet at the end of 2007 reflected
$2.0 million of
unrestricted cash, cash equivalents and marketable securities,
compared
to $15.4 million as of year-end 2006. Following the fourth quarter
of
2007, MiddleBrook completed a private placement of common stock
and
warrants resulting in the addition of $19.9 million of net proceeds
to
the Company.
FINANCIAL GUIDANCE
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.
CONFERENCE
CALL
The Company has scheduled a conference call for today, Tuesday,
March 4, 2008 at 10:30 AM ET. During the call, Dr. Edward Rudnic,
president and CEO, and Robert Low, vice president, finance and CFO,
will discuss quarterly results and other corporate activities. Investors
can call 1-800-813-8504 (domestic) and 1-706-643-7752 (international)
prior to the 10:30 AM start time and ask for the MiddleBrook Pharmaceuticals
conference call hosted by Dr. Rudnic. A replay of the call will
be available on Tuesday, March 4, 2008 beginning at 12:30 PM ET
and will be accessible until Tuesday, March 11, 2008 at 5:00 PM
ET. The replay call-in number is 1-800-642-1687 for domestic callers
and 1-706-645-9291 for international callers. The access number
is 37507035.
The conference call will also be broadcast simultaneously
on the Company's website, www.middlebrookpharma.com. Investors should
click
on the Investor Relations tab and are advised to go to the website
at least 15 minutes early to register, download, and install any
necessary audio software. The call will also be archived on the
MiddleBrook website.
About MiddleBrook Pharmaceuticals:
MiddleBrook
Pharmaceuticals, Inc. (Nasdaq: MBRK) 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 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 www.middlebrookpharma.com/products_antibiotics/keflex_antibiotics.aspx.
This
announcement contains historical financial information as of
and for three-month and twelve-month periods ended December 31,
2007 and December 31, 2006 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.
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