KYTHERA Biopharmaceuticals Announces 2012 Operating Results
LOS ANGELES -- March 21, 2013
KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today reported financial
results for its quarter and year ended December 31, 2012.
“2012 was a transformational year for KYTHERA, during which we strengthened
our capital position through the successful completion of our initial public
offering with gross proceeds of $81 million,” said Keith Leonard, KYTHERA’s
President and CEO. “We also made important advances in our clinical
development program for ATX-101, an investigational injectable drug for the
reduction of unwanted submental fat, commonly known as double chin. In April,
we announced positive European Phase III clinical trial results in conjunction
with Bayer, our collaborator outside of the U.S. and Canada. Additionally, in
August, we completed enrollment in our pivotal U.S. and Canadian Phase III
clinical trials and expect to report topline results in mid-2013. If approved,
ATX-101 will be the first drug approved for the reduction of submental fat.
Over the coming year we will continue to advance our development program for
this potential first-in-class injectable drug.”
2012 Summary Financial Results
Cash and cash equivalents totaled $79.3 million at December 31, 2012. This
compares to $34.6 million at December 31, 2011. Based on current operating
plans, the Company believes its existing cash and cash equivalents will allow
it to fund its operating plan through at least the next 12 months.
Research and development expenses totaled $14.4 million for the fourth quarter
2012 and $43.2 million for the full year 2012, compared to $6.2 million for
the fourth quarter 2011 and $15.8 million for the full year 2011. The increase
in research and development expenses in 2012 compared to the similar periods
in 2011 is primarily attributable to the initiation of pivotal Phase III
trials in the U.S. and Canada.
General and administrative expenses totaled $3.4 million for the fourth
quarter of 2012 and $10.5 million for the year ended December 31, 2012,
compared to $1.9 million for the fourth quarter of 2011 and $6.9 million for
the year ended December 31, 2011. The increase in general and administrative
expenses in 2012 compared to the similar periods in 2011 is primarily
attributable to increased personnel costs, increased marketing in preparation
for a potential commercial launch of ATX-101 and services associated with the
support of operations as a public company.
Net loss was $18.0 million for the fourth quarter of 2012 and $36.8 million
for the year ended December 31, 2012, compared to $5.6 million for the fourth
quarter of 2011 and $11.2 million for the year ended December 31, 2011.
Key 2012 and Recent Accomplishments
*In March 2013, announced the appointment of Frederick Beddingfield, III,
MD, PhD, as Chief Medical Officer. He joins the company from Allergan,
Inc., where he worked in an executive capacity across the entire
aesthetics portfolio including Botox® Cosmetic, Juvederm® and Latisse®.
Dr. Beddingfield most recently held the role of Allergan’s Vice President
and Therapeutic Area Head, Dermatology and Aesthetics.
*In March 2013, four abstracts were presented at the 71st American Academy
of Dermatology (AAD) Annual Meeting that evaluated the safety, efficacy
and pharmacokinetics of ATX-101.
*In October 2012, completed its initial public offering of 5,060,000 shares
of its common stock at an initial public offering price of $16.00 per
share, which included the exercise in full by the underwriters of their
option to purchase up to 660,000 additional shares of common stock. The
Company received net proceeds of approximately $72.5 million after
deducting underwriting discounts, commissions and offering costs.
*In August 2012, completed enrollment in two pivotal U.S. and Canadian
Phase III clinical trials of ATX-101.
*In April 2012, Bayer announced positive results from two pivotal European
Phase III multi-center, randomized, double blind, placebo controlled
trials of ATX-101. ATX-101 was found to be well tolerated and resulted in
a statistically significant reduction in submental fat, as assessed by a
validated clinician scale and a patient satisfaction scale.
ATX-101 is a potential first-in-class injectable drug candidate under clinical
investigation for the reduction of unwanted submental fat. ATX-101 is a
proprietary synthetic formulation of deoxycholate, a well-characterized
endogenous bile acid that is naturally occurring in the body and promotes the
natural breakdown of dietary fat. ATX-101 is designed to be a locally-injected
drug that causes proximal, preferential destruction of adipocytes, or fat
cells, with minimal effect on surrounding tissue. Based on clinical trials
conducted to date, ATX-101 has exhibited significant, meaningful and durable
results in the reduction of submental fat, which commonly presents as an
undesirable “double chin.” These results correspond with subject satisfaction
measures demonstrating meaningful improvement in perceived chin appearance.
In August 2010, Bayer signed a licensing and collaboration development
agreement with KYTHERA, thereby obtaining development and commercialization
rights to ATX-101 outside of the U.S. and Canada. Bayer recently completed two
pivotal Phase III trials of ATX-101 in Europe for the reduction of submental
fat. Topline results from these trials were reported in the second quarter of
2012. KYTHERA completed enrollment in its pivotal Phase III clinical program
for ATX-101 in more than 1,000 subjects, randomized to ATX-101 or placebo, in
70 centers across the U.S. and Canada in August 2012. The Company expects to
release topline results in mid-2013.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of novel
prescription products for the aesthetic medicine market. KYTHERA initiated its
pivotal Phase III clinical program for ATX-101 in March 2012, and completed
enrollment of more than 1,000 patients, randomized to ATX-101 or placebo, in
70 centers across the U.S. and Canada in August 2012. KYTHERA also maintains
an active research interest in hair and fat biology. Find more information at
To the extent that statements contained in this press release are not
descriptions of historical facts regarding KYTHERA, they are forward-looking
statements reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, including our expectations regarding the timing of
reporting data from our Phase III clinical trials of ATX-101, our expectations
regarding the sufficiency of our cash resources for the next 12 months and the
potential to commercialize ATX-101. Such forward-looking statements involve
substantial risks and uncertainties that could cause our clinical development
programs, future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent in the
clinical drug development process, including the regulatory approval process,
and the development progress of our collaborative partners, our substantial
dependence on ATX-101, the requirement of substantial additional financing to
achieve our goals and other matters that could affect the availability or
commercial potential of our drug candidate. KYTHERA undertakes no obligation
to update or revise any forward-looking statements. For a further description
of the risks and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as risks relating
to the business of the Company in general, see KYTHERA’s reports filed with
the Securities and Exchange Commission, including its Quarterly Report on Form
10-Q for the quarter ended September 30, 2012 and, when filed, our Annual
Report on Form 10-K for the year ended December 31, 2012.
KYTHERA BIOPHARMACEUTICALS, INC.
CONDENSED FINANCIAL RESULTS
(in thousands, except per share amounts)
Three Months Ended Years Ended
December 31, December 31,
2012 2011 2012 2011
License income $ — $ 2,886 $ 19,687 $ 12,985
Sublicense — 264 1,936 1,188
Gross margin — 2,622 17,751 11,797
Research and 14,376 6,173 43,184 15,766
General and 3,403 1,945 10,505 6,879
operating 17,779 8,118 53,689 22,645
Loss from (17,779 ) (5,496 ) (35,938 ) (10,848 )
other interest (257 ) (132 ) (861 ) (304 )
Net loss $ (18,036 ) $ (5,628 ) $ (36,799 ) $ (11,152 )
Net loss per
share, basic $ (1.04 ) $ (0.44 ) $ (2.62 ) $ (1.00 )
weighted 17,330,000 12,932,000 14,058,000 11,139,000
CONDENSED BALANCE SHEET DATA
Cash and cash equivalents $ 79,311 $ 34,577
Working capital 71,367 27,964
Total assets 96,222 45,079
Redeemable convertible preferred stock — 107,587
Accumulated deficit (120,306 ) (83,507 )
Total stockholders' equity (deficit) $ 68,906 $ (81,024 )
KYTHERA Biopharmaceuticals, Inc.
Associate Director, Investor Relations
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