Advancis Pharmaceutical Provides Update on Keflex Launch
October 13 2006 - 8:05AM
PR Newswire (US)
Retail Stocking Delays Result in Lowering of 2006 Revenue
Expectations; Keflex 750 Soon to be Stocked in More Than 20,000
U.S. Pharmacies GERMANTOWN, Md., Oct. 13 /PRNewswire-FirstCall/ --
Advancis Pharmaceutical Corporation (NASDAQ:AVNC), a pharmaceutical
company focused on developing and commercializing novel
anti-infective products, today provided an update on the launch of
its recently approved 750mg strength Keflex Capsules (Cephalexin,
USP) and revised its financial expectations for the remainder of
2006. Retail pharmacy stocking of Keflex 750 was lower than
expected in August and September of 2006, and, as a result, the
Company has reissued financial guidance for 2006. In late
September, Advancis commenced specific initiatives to significantly
increase the number of pharmacies stocking Keflex 750. Based on
these initiatives, the Company believes more than 20,000 pharmacies
will carry Keflex 750 by the end of October, including several
major retail pharmacy chains that will stock Keflex 750 in a
majority of their stores. "While our Keflex 750 launch has taken
longer to develop than our original expectations, we are optimistic
that the expanded distribution of Keflex 750 to more than 20,000
pharmacies, especially in the major chains, will enable us to meet
our 2007 and long-term goals for the product," said Dr. Edward
Rudnic, Advancis president and CEO. "We do not believe that this
delay will have a material effect on our performance next year or
impact the long-term potential of Keflex 750." FINANCIAL GUIDANCE
Due to the impact from a delayed post-launch ramp of Advancis'
Keflex 750mg capsules, financial guidance for 2006 has been
reduced. The Company cautions that its revised expectations are
based on limited prescription data to date and assume a favorable
market acceptance of Keflex 750 for the remainder of 2006. Total
revenue for 2006 from sales of Keflex products is now expected to
be approximately $7 million to $10 million, down from prior
expectations of $16 million to $17 million. The Company generally
recognizes revenue from product sales at the time products are
delivered to customers. The revenue guidance assumes the accounting
policy for Keflex 750 sales in 2006 will also be to generally
recognize revenue as products are delivered to customers. Net loss
for the year is expected to be between $37 million and $40 million,
or approximately $1.21 to $1.31 per diluted common share; compared
to previous loss expectations of between $32 million and $37
million, or approximately $1.05 to $1.25 per diluted common share.
Cash, cash equivalents, and marketable securities at the end of
2006 are now expected to be approximately $4 million to $6 million,
changed from prior expectations of approximately $12 million to $13
million. As previously stated, given suitable market conditions and
favorable financing terms, the Company may consider raising
additional capital during 2006 or 2007. KEFLEX OVERVIEW Following
U.S. Food and Drug Administration approval in May, 2006, Advancis
commenced its commercialization initiatives for Keflex 750mg
capsules through a targeted nationwide sales force of 75 contract
sales representatives and eight Advancis district sales managers.
On July 25, 2006, the Company announced that Keflex 750mg capsules
had been manufactured and packaged, and that it had shipped Keflex
bottles to pharmacies nationwide for initial inventory stocking.
Advancis contract sales representatives began directly promoting
Keflex 750mg capsules to targeted physicians as well as providing
patient starter samples in late July 2006. Advancis believes the
new Keflex 750mg strength provides healthcare professionals a more
convenient way to deliver a total daily dose of 1500mg per day, by
providing them an option to prescribe just two daily doses of the
750mg capsules. Keflex is approved for adult dosages ranging from
one to four grams per day in divided doses; however, the majority
of prescriptions are currently written for cephalexin 500mg three
times daily -- totaling 1500mg per day. Cephalexin, the generic
form of Keflex, is the third most prescribed outpatient antibiotic
in the United States, with more than 25 million prescriptions
written annually representing a retail market size of approximately
$500 million. Cephalexin is the number-one most prescribed oral
cephalosporin antibiotic and is also the number-one recommended
oral antibiotic therapy for uncomplicated skin and skin structure
infections. About Keflex: Keflex(R) Capsules (Cephalexin, 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. Keflex is currently available in
250mg capsules, 500mg capsules, 750mg capsules, and powder for oral
suspension. Keflex is contraindicated in patients with known
allergy to the cephalosporin group of antibiotics. Before therapy
with cephalexin is instituted, careful inquiry should be made to
determine whether the patient has had previous hypersensitivity
reactions to cephalexin, cephalosporins, penicillins, or other
drugs. Keflex should be administered with caution in the presence
of markedly impaired renal function or a history of
gastrointestinal disease, particularly colitis. More information on
Keflex and prescribing information are available at
http://www.keflex.com/ . About Advancis Pharmaceutical Corporation:
Advancis Pharmaceutical Corporation (NASDAQ:AVNC) is a
pharmaceutical company focused on the development and
commercialization of pulsatile 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 than those under standard treatment regimens. Based on
this finding, Advancis 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, Advancis 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 Advancis, please
visit http://www.advancispharm.com/ . 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 Advancis' 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 future development plans, clinical trials, potential
commercial success, and any financial forecasts and projections for
the full year of 2006 and thereafter included under the Financial
Guidance section of this announcement. The actual results realized
by Advancis 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) reach
profitability, (2) prove that the preliminary findings for its
product candidates are valid, (3) receive required regulatory
approvals, (4) successfully conduct clinical trials in a timely
manner with favorable results, (5) establish its competitive
position for its products, (6) develop and commercialize products
that are superior to existing or newly developed competitor
products, (7) develop products without any defects, (8) have
sufficient capital resources to fund its operations, (9) protect
its intellectual property rights and patents, (10) implement its
sales and marketing strategy, (11) successfully attract and retain
collaborative partners, (12) successfully commercialize and gain
market acceptance for its Keflex products, and (13) 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.
Advancis 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.
DATASOURCE: Advancis Pharmaceutical Corporation CONTACT: Robert
Bannon, Vice President, Investor Relations & Corporate
Communications of Advancis Pharmaceutical Corp., +1-301-944-6710,
Web site: http://www.advancispharm.com/ http://www.keflex.com/
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