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MiddleBrook Pharmaceuticals Reports Third Quarter 2007 Results
Keflex Product Sales Total $3.1 Million in Quarter; Amoxicillin
PULSYS NDA
Review Ongoing - PDUFA Date in January 2008
GERMANTOWN, Md.
Nov.
14
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 ended September 30, 2007.
MiddleBrook reported third quarter 2007 revenue of $3.1 million,
up from revenue of $2.7 million in the second quarter of 2007 and
from $2.4 million in the third quarter of 2006. Revenue for the
first nine months of 2007 increased to $7.6 million, from revenue
of $3.6 million for the first nine months of 2006.
MiddleBrook reported research
and development (R&D) expenses
in the third quarter of $5.5 million, compared to second quarter
2007 R&D expenses of $5.4 million and third quarter 2006 R&D
expenses of $5.7 million. Total expenses for the third quarter of
2007 were $13.2 million, compared to $12.2 million in the second
quarter of 2007 and $12.2 million in the third quarter of 2006.
Net loss was $10.1 million for the third quarter, compared to a
net loss of $9.5 million in the second quarter of 2007 and a net
loss of $9.9 million in the third quarter of 2006. Net loss for
the first nine months of 2007 was $33.2 million, compared to a net
loss of $28.2 million in the first nine months of the prior year.
Net loss per share applicable to common stockholders during the
third quarter of 2007 was ($0.22), compared to a net loss per share
of ($0.21) in the prior quarter, and a net loss per share of ($0.33)
in the comparable quarter of last year. Net loss per share applicable
to common stockholders during the first nine months of 2007 was
($0.78), down from a net loss per share of ($0.93) in the first
nine months of 2006.
"We believe the Amoxicillin PULSYS NDA review process has
progressed very well thus far and we look forward to continuing
to work with the FDA throughout the remainder of their review," stated
Edward M. Rudnic, Ph.D., president and CEO of MiddleBrook.
OPERATIONAL HIGHLIGHTS
Amoxicillin PULSYS NDA Review -- PDUFA Date January 23, 2008
On May 22, 2007, MiddleBrook's New Drug Application (NDA) for its
once- daily Amoxicillin PULSYS product was accepted for filing by
the U.S. Food and Drug Administration (FDA). MiddleBrook has worked
closely with the FDA throughout the subsequent review process and
anticipates a decision on the application on its Prescription Drug
User Fee Act (PDUFA) target action date of January 23, 2008.
Amoxicillin is currently not approved for once-daily dosing to
treat pharyngitis. If approved for marketing, physicians prescribing
Amoxicillin PULSYS would have available the first once-daily product
in the aminopenicillin class for the treatment of pharyngitis while
utilizing approximately one-half the amount of amoxicillin currently
used. About 15 million patients annually seek relief of sore throat
symptoms in the United States.
Keflex(R) Capsules (Cephalexin, USP) -- Commercialization Update
During the third quarter, MiddleBrook continued the commercialization
of its 750 mg strength Keflex capsules through a targeted and dedicated
national contract sales force and MiddleBrook district sales managers.
Based on prescription data from IMS Health, total prescriptions
filled for Keflex 750 mg capsules in the third quarter of 2007 were
83,767 prescriptions, up from second quarter 2007 total prescriptions
of 82,621.
MiddleBrook recently conducted a review of its Keflex sales initiatives
and as a result reduced the size of its sales force to approximately
30 contract sales representatives and three MiddleBrook district
sales managers.
Financing Raises Up To an Additional $10 Million in Gross Proceeds
As announced on November 7, 2007, MiddleBrook closed an agreement
with Deerfield Management, a healthcare investment fund and one
of the Company's largest equity shareholders, raising up to $10
million in cash through the sale of the Company's cephalexin assets,
which the Company will have the option to repurchase in the future.
Under the terms of the agreement, the Company received $7.5 million,
less a $0.5 million payment to Deerfield, with an additional $2.5
million to become available, if necessary, if and when the Company
receives FDA approval of Amoxicillin PULSYS.
The agreement is designed to provide the Company with the financial
flexibility to continue its ongoing strategic discussions through
the PDUFA date for Amoxicillin PULSYS. The cash provided from the
Deerfield agreement also allowed MiddleBrook to repay in full its
outstanding loan facility with Merrill Lynch and eliminate the associated
interest and principal payments.
Process to Explore Strategic Alternatives Ongoing
As previously announced, MiddleBrook's board of directors authorized
the Company to evaluate various strategic alternatives to further
enhance shareholder value. Subsequently, MiddleBrook retained Pacific
Growth Equities, LLC, an investment bank focused on the life sciences
industry, to assist in the evaluation of a full range of strategic
alternatives available to the Company.
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
$3.1 million in the third quarter of 2007, up from revenue of
$2.7 million in the prior quarter, and $2.4 million for the third
quarter of 2006. Revenue for the quarter included $1.8 million that
had been deferred in the previous quarter, as well as one month's
actual sales in the quarter as the company resumed shipments of product
in September upon completion of relabeling. Revenue during the first
nine months of 2007 was $7.6 million, up from revenue of $3.6 million
during the first nine months of 2006. Increased product sales were
mainly attributable to the Company's Keflex 750 mg strength capsules
which were launched during the third quarter of 2006.
-- Operating expenses. Third quarter research and development
expenses,
primarily consisting of salaries, stock-based compensation, and related
expenses for personnel and the costs of the Company's clinical trials
and research initiatives, were $5.5 million, compared to $5.4 million
in the previous quarter and $5.7 million in the third quarter of 2006.
Additional costs of $0.8 million were incurred in the third quarter as
the Company consolidated operations into a single site, but these were
offset by lower personnel costs and reduced spending on developing the
Company's amoxicillin manufacturing facility.
Selling, general and administrative
(SG&A)
expenses totaled
$6.5 million in the third quarter of 2007, up from $6.3 million in the
second quarter of 2007, and $6.1 million in the third quarter of 2006.
SG&A expenses increased in the third quarter of 2007 versus the second
quarter of 2007 primarily due to costs associated with consolidating
operations into a single site.
Stock-based compensation recorded in the third quarter 2007 was
a total
of $0.7 million, consisting of $0.2 million recorded in R&D
expense and
$0.5 million recorded in SG&A expense. In the second quarter
2007 and
third quarter 2006, total stock-based compensation was an expense of
$0.7 million and $1.1 million, respectively.
-- Net loss for the third quarter of 2007 was $10.1 million. This
compares
to a net loss of $9.5 million in the second quarter of 2007, and
$9.9 million in the third quarter of 2006. Net loss for the first nine
months of 2007 was $33.2 million, compared to a net loss of
$28.2 million for the first nine months of 2006.
-- Net loss per share applicable to common stockholders for the
third
quarter of 2007 was ($0.22), compared to a loss per common share of
($0.21) in the prior quarter and ($0.33) in the third quarter of 2006.
Per share figures were computed on the basis of an average of
46.7 million shares outstanding in the third quarter of 2007,
45.3 million shares outstanding in the second quarter of 2007, and
30.3 million shares outstanding in the third quarter of 2006.
-- Cash and marketable securities decreased by $6.3 million during
the
third quarter. Changes were composed of $10.0 million of operating
losses, $0.7 million in loan payments; offset by $2.2 million for non-
cash expenses and $2.2 million for working capital changes and other
items.
-- The Balance Sheet at the end of the third quarter of 2007 reflected
$5.9 million of unrestricted cash, cash equivalents and marketable
securities, compared to $12.2 million as of June 30, 2007, and
$12.6 million as of September 30, 2006. Following the third quarter of
2007, MiddleBrook entered into an agreement with Deerfield Management
resulting in the addition of $7.5 million of gross proceeds to the
Company. MiddleBrook used a portion of the proceeds from this
financing to retire the Company's outstanding credit facility of
approximately $4.6 million.
-- Deferred product revenue. Due to the Company's corporate name
change on
June 28, 2007, inventories of products on hand at that time were
required to be relabeled. At the end of the second quarter 2007, the
Company offered a one-time incentive to wholesalers to purchase up to a
two-month supply of Keflex products, to avoid stock-out situations at
wholesalers during the relabeling process. This incentive offer
resulted in orders of approximately $2.0 million of gross sales.
Revenue recognition for this transaction was deferred as of June 30,
2007, and the Company recognized net revenue of $1.8 million during the
third quarter of 2007, the period when the related product was sold by
the wholesalers.
FINANCIAL GUIDANCE AND FUTURE CASH REQUIREMENTS
As previously announced, in order to preserve corporate resources,
the Company has undertaken cost reductions during 2007, including
personnel reductions, postponement of PULSYS clinical development
programs other than Amoxicillin PULSYS for adults, and elimination
of other discretionary spending.
Total revenue for 2007 is expected to be approximately $10 million
to $12 million, resulting from Keflex product sales. Total cash
used in operating activities and capital expenditures in 2007 is
estimated to be between $33 and $35 million.
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 through the Company's
PDUFA action date of January 23, 2008. These 2007 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, Wednesday,
November 14, 2007 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 November 14, 2007 beginning at 12:30 PM ET and will
be accessible until Wednesday, November 21, 2007 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 23072308.
The conference call will also be broadcast simultaneously on the
Company's website, http://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, formerly Advancis Pharmaceutical Corporation)
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 a portfolio of
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(TM). By examining the resistance patterns
of bacteria and applying its delivery technologies, MiddleBrook
has the potential to redefine infectious disease therapy and significantly
improve drug efficacy, shorten length of therapy, and reduce drug
resistance versus currently available antibacterial products. For
more on MiddleBrook, please visit http://www.middlebrookpharma.com.
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 and nine-month periods ended September 30,
2007 and September 30, 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 and 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 2007 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 an ongoing concern, (2) increase Keflex 750 sales, (3)
obtain FDA approval for its Amoxicillin PULSYS product candidate,
(4) successfully reduce costs, (5) maintain compliance with provisions
under its financing arrangements, (6) reach profitability, (7) prove
that the preliminary findings for its product candidates are valid,
(8) receive required regulatory approvals, (9) successfully conduct
clinical trials in a timely manner, (10) establish its competitive
position for its products, (11) develop and commercialize products
that are superior to existing or newly developed competitor products,
(12) develop products without any defects, (13) have sufficient
capital resources to fund its operations, (14) protect its intellectual
property rights and patents, (15) implement its sales and marketing
strategy, (16) successfully attract and retain collaborative partners,
(17) successfully commercialize and gain market acceptance for its
Keflex products, (18) successfully obtain sufficient manufactured
quantities of its drug products at acceptable rates, and (19) 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.
MIDDLEBROOK PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Sept 30, Nine Months Ended Sept 30,
2007 2006 2007 2006
Product sales $3,144,532 $2,369,975 $7,598,127 $3,566,563
Costs and
expenses:
Cost of product
sales 1,183,772 440,159 1,864,643 517,765
Research and
development 5,509,093 5,737,047 18,485,164 19,700,263
Selling, general
and administrative 6,475,742 6,069,529 20,473,947 13,001,312
Total
expenses 13,168,607 12,246,735 40,823,754 33,219,340
Loss from
operations (10,024,075) (9,876,760) (33,225,627) (29,652,777)
Interest income 126,655 221,333 481,855 747,921
Interest expense (159,359) (241,735) (528,924) (292,018)
Other income - - 75,000 976,815
Net loss $(10,056,779) $(9,897,162) $(33,197,696) $(28,220,059)
Basic and diluted
net loss per share $(0.22) $(0.33) $(0.78) $(0.93)
Shares used in
calculation of basic
and diluted net
loss per share 46,650,833 30,302,628 42,831,867 30,209,948
MIDDLEBROOK PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2007 2006
ASSETS
Current assets:
Cash and cash equivalents $4,987,690 $14,856,738
Marketable securities 929,812 522,723
Accounts receivable, net 1,331,764 303,514
Inventories, net 1,088,913 2,077,390
Prepaid expenses and other
current assets 1,199,515 1,682,685
Total current assets 9,537,694 19,443,050
Property and equipment, net 11,533,248 11,764,627
Restricted cash 872,180 872,180
Deposits and other assets 348,006 1,548,585
Intangible assets, net 7,509,070 8,377,327
Total assets $29,800,198 $42,005,769
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $2,991,269 $2,285,736
Accrued expenses and advances 5,898,096 7,817,224
Lines of credit and short-term debt 4,888,889 6,888,889
Note payable - 75,000
Deferred product revenue - 189,000
Total current liabilities 13,778,254 17,255,849
Deferred contract revenue 11,625,000 11,625,000
Deferred rent and credit on
lease concession 1,204,506 1,252,900
Total liabilities 26,607,760 30,133,749
Commitments and contingencies
Stockholders' equity:
Preferred stock, undesignated - -
Common stock, par value 466,955 363,625
Capital in excess of par value 189,008,385 164,593,930
Accumulated deficit (186,283,158) (153,085,462)
Accumulated other comprehensive
income (loss) 256 (73)
Total stockholders' equity 3,192,438 11,872,020
Total liabilities and
stockholders' equity $29,800,198 $42,005,769
MIDDLEBROOK PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine Months Ended September 30,
2007 2006
Cash flows from operating activities:
Net loss $(33,197,696) $(28,220,059)
Adjustments to reconcile net
income to net cash used
in operating activities:
Depreciation and amortization 3,447,503 2,949,486
Stock-based compensation 1,971,687 2,861,585
Deferred rent and credit on
lease concession (48,393) (4,297)
Amortization of premium on
marketable securities (69,242) 222,332
Loss on disposal of fixed assets 23,185
Recognition of advance payment
for potential sale of Keflex (1,000,000)
Changes in:
Accounts receivable (1,028,251) (1,255,473)
Inventories 988,477 (1,110,616)
Prepaid expenses and other
current assets 483,170 220,484
Deposits other than on
property and equipment, and
other assets 249,667 -
Accounts payable 705,533 1,215,109
Accrued expenses and advances (1,975,496) 608,590
Deferred product and contract
revenue (189,000) 270,061
Net cash used in
operating activities (28,662,041) (23,219,613)
Cash flows from investing activities:
Purchase of marketable securities (5,867,519) (13,274,560)
Sale and maturities of marketable
securities 5,530,000 19,655,000
Purchases of property and
equipment (246,330) (50,653)
Deposits on property and
equipment (1,150,624) (250,000)
Proceeds from sale of fixed
assets - 25,000
Change in restricted cash - 730,444
Net cash provided by
(used in) investing
activities (1,734,473) 6,835,231
Cash flows from financing activities:
Proceeds from issuance of debt,
net of issue costs - 7,792,976
Payments on lines of credit (2,000,000) (1,913,062)
Proceeds from private placement
of common stock,
net of issue costs 22,412,260 -
Proceeds from exercise of common
stock options 115,206 280,156
Net cash provided by
financing activities 20,527,466 6,160,070
- -
Net decrease in cash and cash
equivalents (9,869,048) (10,224,312)
Cash and cash equivalents,
beginning of period 14,856,738 18,116,968
Cash and cash equivalents, end of
period 4,987,690 7,892,656
SOURCE MiddleBrook Pharmaceuticals, Inc.
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