Company prepares to launch Moxatag(TM), the first and only
FDA-approved once-daily amoxicillin, in the first quarter of 2009
GERMANTOWN, Md., Nov. 13 /PRNewswire-FirstCall/ -- Highlights --
MiddleBrook Pharmaceuticals received stockholder approval for and
closed a $100 million financing transaction with Equity Group
Investments, L.L.C. (EGI). (Sept.) -- MiddleBrook repurchased the
Keflex(R) assets for approximately $11.0 million from Deerfield
Management and redeemed the Deerfield warrant for $8.8 million in
conjunction with the EGI transaction. (Sept.) -- John Thievon
became president & CEO, and David Becker became executive vice
president & CFO effective upon the close of the EGI
transaction. (Sept.) -- The MiddleBrook team was expanded to
include additional senior leaders with proven track records in
commercial operations. (Sept. - Nov.) -- MiddleBrook engaged
TalenTactics(TM) to lead its national sales force hiring efforts
and teamed with VCG & Associates to obtain managed-care
coverage for Moxatag (extended-release amoxicillin) Tablets, 775mg.
(Oct.) -- The Company's Moxatag patents were listed in FDA's Orange
Book. (Oct.) -- MiddleBrook President & CEO John Thievon
presented at the 10th Annual Rodman & Renshaw Healthcare
Conference. (Nov.) MiddleBrook Pharmaceuticals, Inc. (NASDAQ:MBRK)
today announced financial and operational results for the quarter
ended Sept. 30, 2008. MiddleBrook President & CEO John Thievon
said, "We have made significant progress since September. We have
expanded the MiddleBrook senior leadership team, and our
accomplished science team is now complemented with operationally
strong executives, many of whom have a shared history of commercial
success." "We will begin recruiting our national field force
shortly, and the entire MiddleBrook team is energized and focused
on the execution of our plan to successfully launch our first
proprietary Pulsys(R) product, Moxatag -- the first and only
FDA-approved once-daily amoxicillin -- in first quarter 2009,"
Thievon continued. Third Quarter 2008 Financial Results:
MiddleBrook reported third quarter 2008 revenue of $2.3 million,
compared to revenue of $3.1 million in the third quarter of 2007.
The lower revenue is due primarily to the fact that during 2007
MiddleBrook reduced the size of its contract sales force from 75 to
30 representatives in order to lower expenses. The Company reported
cost of goods sold in the amount of $0.3 million, compared to $1.2
million in the prior year period. The decline is due primarily to
the third quarter 2007 write-off of obsolete immediate-release
Keflex (cephalexin USP) capsules inventory. Research and
development (R&D) expenses in the third quarter were $6.9
million, compared to third quarter 2007 R&D expenses of $5.5
million. Third quarter 2008 R&D expenses include a loss on
R&D equipment sold during the quarter of $1.0 million and a
$3.1 million impairment of leasehold improvements related to
currently unused leased space which the Company plans to sublease.
In 2007, R&D headcount was reduced and all development
activities outside of those related to Moxatag were put on hold.
These actions partially offset the expense associated with the loss
and the impairment. Selling, general and administrative (SG&A)
expense was $7.0 million in the third quarter of 2008, compared to
$6.5 million in the prior-year period. Third quarter 2008 SG&A
expense includes $2.1 million in severance expense associated with
management changes related to the EGI transaction. The severance
expense more than offset savings generated from lower headcount,
including the reduced contract sales force and the other cost
reduction efforts. Net loss was $(12.5) million for the third
quarter, compared to a net loss of $(10.1) million in the third
quarter of 2007. Net loss per share during the third quarter of
2008 was $(0.19), compared to a net loss per share of $(0.22) in
the prior- year quarter. The number of shares used in the per share
calculation was 64.6 million for the current quarter and includes
the weighted average impact of the 30.3 million new shares
purchased by EGI in Sept. 2008. Outlook: MiddleBrook now expects
2008 net sales to be approximately $9.0 million as a result of
declining Keflex prescriptions due to the lower number of physician
detail calls made as a result of the reduction in the size of the
Company's contract sales force. At the end of 2008, MiddleBrook
anticipates that it will have combined cash and marketable
securities balance in excess of $70 million. Cash utilization
during the fourth quarter 2008 is expected to increase as a result
of the new sales infrastructure and the purchase of the initial
Moxatag inventory for the upcoming launch. MiddleBrook's current
plan anticipates that 2009 net sales will be in excess of $40
million for Moxatag and Keflex combined, assuming the successful
commercial launch of Moxatag in the first quarter of 2009 and no
generic competition for Keflex 750mg. As part of MiddleBrook's
current 2009 plan, MiddleBrook will build a field force consisting
of about 270 professional field sales representatives at a
fully-burdened annual cost of approximately $190 thousand per sales
representative. MiddleBrook's current 2009 plan indicates that the
Company expects to advance the Keflex Pulsys development project,
contingent upon the success of the Moxatag launch. Additionally,
the current MiddleBrook 2010 plan supports the potential for
achieving operating profitability without the need for additional
equity financing. Third Quarter 2008 Conference Call and Webcast
MiddleBrook Pharmaceuticals, Inc. is scheduled to announce its
financial results for the third quarter of 2008 today, Thursday,
Nov. 13, 2008, before the market opens. At 9:00 a.m. (ET) today,
MiddleBrook management will conduct a conference call to review the
Company's third quarter financial results. To listen live to the
call, dial 1-800-813-8504 or 1-706-643-7752. A replay of the call
will be available starting at approximately 11 a.m. on Nov. 13
through 5 p.m. on Nov. 20, 2008. To listen to the replay, dial
1-800-642- 1687 or 1-706-645-9291 and enter the conference ID #
71538195. A live audio webcast of the conference call also will be
available by going to the Investor Relations section of
MiddleBrook's web site, http://www.middlebrookpharma.com/. A replay
of the webcast will be available starting at approximately 11 a.m.
on Nov. 13 through 5 p.m. on Dec. 12, 2008. About Moxatag: Moxatag
(amoxicillin extended-release) Tablets, 775mg, is a once-a-day
extended-release formulation of amoxicillin for oral administration
consisting of three components: one immediate-release component and
two delayed-release components. The three components of Moxatag are
combined in a specific ratio to prolong the release of amoxicillin
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. For more information about Moxatag,
please visit http://www.middlebrookpharma.com/. About Keflex:
Keflex, immediate-release (cephalexin USP) capsules, 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.
About MiddleBrook Pharmaceuticals: MiddleBrook Pharmaceuticals,
Inc. (NASDAQ:MBRK) is a pharmaceutical company focused on
developing and commercializing anti-infective products that fulfill
unmet medical needs. We are currently developing a portfolio of
anti- infective products utilizing our proprietary, once-a-day
pulsatile delivery technology called Pulsys. Our near-term
corporate strategy is to improve dosing regimens and/or frequency
of dosing which we believe will result in improved patient dosing
convenience and compliance for antibiotics that have been used and
trusted by physicians and patients for decades. The Company
currently markets the Keflex brand of cephalexin and has received
regulatory approval for Moxatag -- the first and only once-daily
amoxicillin product approved for marketing in the U.S. For more
information about MiddleBrook, please visit
http://www.middlebrookpharma.com/. Forward-Looking Statements This
announcement contains forward-looking statements, within the
meaning of Section 21E of the Securities Exchange Act of 1934 and
Section 27A of the Securities Act of 1933, that involve risks and
uncertainties. In some cases, forward-looking statements are
identified by words such as "believe," "anticipate," "expect,"
"intend," "plan," "potential," "estimate," "will," "may,"
"predict," "should," "could," "would" and similar expressions. You
should not place undue reliance on these forward-looking
statements, which speak only as of the date of this announcement.
All of these forward-looking statements are based on information
available to us at this time. Actual results could differ from
those projected in these forward-looking statements as a result of
many factors, including those identified in the sections titled
"Risk Factors," in our Registration Statement on Form S-3 as filed
with the Securities and Exchange Commission on October 17, 2008,
and in our "Management's Discussion and Analysis of Financial
Condition and Results of Operations" and elsewhere in our Annual
Report on Form 10-K for the year ended Dec. 31, 2007 and in similar
disclosures made by us from time to time in our other filings with
the Securities and Exchange Commission. We undertake no obligation
to update forward-looking statements, whether as a result of new
information, future events or otherwise. You are advised, however,
to consult any further disclosures we make on related subjects in
our filings with the Securities and Exchange Commission.
MiddleBrook, MiddleBrook Pharmaceuticals (stylized), MiddleBrook
Pharmaceuticals, Inc., Pulsys, Moxatag and Keflex are our
trademarks and have been registered in the U.S. Patent and
Trademark Office or are the subject of pending U.S. trademark
applications. Each of the other trademarks, tradenames or services
marks appearing in this document belongs to its respective holder.
MiddleBrook Pharmaceuticals, Inc. Consolidated Statements of Income
(Amounts in thousands, except per share amounts) For the Three
Months For the Nine Months Ended September 30, Ended September 30,
2008 2007 2008 2007 Product sales $2,267 $3,145 $7,183 $7,598 Costs
and expenses: Cost of product sales 350 1,184 1,345 1,865 Research
and development 6,898 5,509 14,270 18,485 Selling, general and
administrative 7,004 6,476 15,695 20,474 Total expenses 14,252
13,169 31,310 40,824 Loss from operations (11,985) (10,024)
(24,127) (33,226) Interest income 172 126 387 482 Interest expense
- (159) - (529) Change in fair value of warrants (954) - (6,714) -
Other income (expense) - - - 75 Loss including noncontrolling
interest (12,767) (10,057) (30,454) (33,198) Loss (gain)
attributable to noncontrolling interest 305 - 485 - Net loss
$(12,462) $(10,057) $(29,969) $(33,198) Basic and diluted net loss
per share applicable to common stockholders $(0.19) $(0.22) $(0.52)
$(0.78) Shares used in calculation of basic and diluted net loss
per share 64,649 46,651 58,021 42,832 MiddleBrook Pharmaceuticals,
Inc. Condensed Consolidated Balance Sheets (Amounts in thousands,
except per share amounts) September 30, December 31, 2008 2007
ASSETS Current assets: Cash and cash equivalents $74,343 $1,952
Marketable securities 8,927 - Accounts receivable, net 577 688
Inventories, net 419 688 Prepaid expenses and other current assets
1,565 1,142 Total current assets 85,831 4,470 Property and
equipment, net 3,637 10,929 Restricted cash 872 872 Deposits and
other assets 426 175 Intangible assets, net 11,691 7,220 Total
assets $102,457 $23,666 LIABILITIES, NONCONTROLLING INTEREST AND
STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts
payable $2,591 $1,660 Accrued expenses 4,945 5,613 Total current
liabilities 7,536 7,273 Warrant liability - 2,100 Deferred contract
revenue 11,625 11,625 Deferred rent and credit on lease concession
955 1,178 Total liabilities 20,116 22,176 Noncontrolling interest -
7,338 Commitments and contingencies Stockholders' equity (deficit):
Preferred stock, $0.01 par value; 25,000 shares authorized, no
shares issued or outstanding at September 30, 2008 and December 31,
2007 - - Common stock, $0.01 par value; 225,000 shares authorized,
and 86,420 and 46,749 shares issued and outstanding at September
30, 2008 and December 31, 2007, respectively 864 467 Capital in
excess of par value 306,743 189,019 Accumulated deficit (225,303)
(195,334) Accumulated other comprehensive income 37 - Total
stockholders' equity (deficit) 82,341 (5,848) Total liabilities,
noncontrolling interest and stockholders' equity (deficit) $102,457
$23,666 MiddleBrook Pharmaceuticals, Inc. Condensed Consolidated
Statements of Cash Flows (Amounts in thousands, except per share
amounts)(unaudited) Nine Months Ended September 30, 2008 2007 Cash
flows from operating activities: Net loss $(29,969) $(33,198)
Adjustments to reconcile net income to net cash in operating
activities: Loss attributable to noncontrolling interest (485) -
Depreciation and amortization 5,850 3,447 Change in fair value of
warrants 6,714 - Stock-based compensation 1,256 1,972 Deferred rent
and credit on lease concession (223) (48) Amortization of premium
on marketable securities (30) (69) Loss on disposal of fixed assets
968 - Changes in: Accounts receivable 111 (1,029) Inventories 269
988 Prepaid expenses and other current assets 472 483 Deposits
other than on property and equipment, and other assets (250) 250
Accounts payable 931 706 Accrued expenses (657) (1,975) Deferred
product revenue - (189) Net cash used in operating activities
(15,043) (28,662) Cash flows from investing activities: Repurchase
of Keflex assets from Deerfield (12,190) - Purchases of marketable
securities (11,240) (5,868) Sale and maturities of marketable
securities 2,380 5,530 Purchases of property and equipment (39)
(246) Deposits on property and equipment - (1,150) Proceeds from
sale of fixed assets 472 - Net cash used in investing activities
(20,617) (1,734) Cash flows from financing activities: Proceeds
from private placement of common stock, net of issue costs 115,943
22,412 Payments on lines of credit - (2,000) Proceeds from exercise
of common stock options 758 115 Proceeds from exercise of common
stock warrants 164 - Payment to settle warrant liability (8,814) -
Net cash provided by financing activities 108,051 20,527 Net
increase (decrease) in cash and cash equivalents 72,391 (9,869)
Cash and cash equivalents, beginning of period 1,952 14,857 Cash
and cash equivalents, end of period $74,343 $4,988 Supplemental
disclosure of cash flow information: Cash paid for interest $--
$475 Supplemental disclosure of noncash transactions:
Reclassification of liability related to early exercises of
restricted stock to equity upon vesting of the restricted stock $--
$19 DATASOURCE: MiddleBrook Pharmaceuticals, Inc. CONTACT: Faith
Pomeroy-Ward, +1-301-944-6585 Web site:
http://www.middlebrookpharma.com/
Copyright
Middlebrook Pharmaceuticals (MM) (NASDAQ:MBRK)
Historical Stock Chart
From Jul 2024 to Aug 2024
Middlebrook Pharmaceuticals (MM) (NASDAQ:MBRK)
Historical Stock Chart
From Aug 2023 to Aug 2024