Otonomy Reports Fourth Quarter and Full Year 2014 Financial Results and Provides Corporate Update
March 18 2015 - 4:14PM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the inner and
middle ear, today reported financial results for the quarter and
year ended December 31, 2014, and provided an update on its
corporate activities and product pipeline. The company will host a
webcast and conference call today at 4:30 p.m. ET.
Fourth Quarter 2014 and Subsequent
Highlights
- Submitted New Drug Application (NDA) to FDA for
AuriProTM: On February 25, 2015, Otonomy submitted an NDA
to the U.S. Food and Drug Administration (FDA) for the approval of
AuriPro as a treatment of middle ear effusion in pediatric patients
undergoing tympanostomy tube placement (TTP) surgery. The NDA
submission is supported by data from two identical randomized,
prospective, double-blind, sham-controlled Phase 3 clinical trials
with a combined total of 532 pediatric patients. In both trials,
AuriPro achieved the primary efficacy endpoint with statistical
significance (p<0.001) and was well tolerated. If approved
within the standard review period, Otonomy expects to launch the
product in the United States during the first quarter of 2016.
- Completed follow-on public offering: In
January 2015, Otonomy completed a follow-on public offering of
2,932,500 shares of its common stock (including exercise of the
underwriters' option to purchase an additional 382,500 shares) at
an offering price of $29.25 per share. Proceeds from the follow-on
offering were approximately $80 million, net of underwriting
discounts, commissions and offering-related transaction costs.
- Completed patient enrollment in Phase 2b trial of
OTO-104 in Ménière's disease: In December 2014, Otonomy
completed patient enrollment in its Phase 2b clinical trial of
OTO-104 in patients with Ménière's disease. The prospective,
randomized double-blind, placebo-controlled study is designed to
assess the efficacy and safety of OTO-104 for the treatment of
Ménière's disease, and to serve as one of two pivotal, single-dose
efficacy trials required to support U.S. regulatory approval. The
trial enrolled a total of 154 patients, exceeding the initial
target of 140 patients. The company expects to report results from
this trial during the second quarter of 2015 and, if results are
positive, to initiate a second pivotal trial of OTO-104 in 2015.
OTO-104 has been granted Fast Track designation by the FDA.
- Obtained rights to clinical and non-clinical data for
OTO-311: In November 2014, Otonomy announced an exclusive
licensing agreement with Ipsen under which Otonomy acquired rights
to utilize Ipsen's clinical and non-clinical gacyclidine data in
the development and registration of OTO-311, a sustained-exposure
formulation of gacyclidine in development for the treatment of
tinnitus.
- Appointed experienced chief commercial
officer: In October 2014, Otonomy appointed Anthony J.
Yost as chief commercial officer. Mr. Yost brings 30 years of
experience in pharmaceutical product sales and marketing that
includes building and managing commercial teams at multiple
companies.
- Enrolled first patients in OTO-104 multiple-dose safety
study: In October 2014, Otonomy enrolled the first
patients in a multiple-dose safety study of OTO-104 in the United
Kingdom in patients with Ménière's disease. The study is designed
to evaluate the safety of quarterly dosing with OTO-104 and is
expected to enroll 125 patients across multiple trial sites in the
United Kingdom.
"Last year was a breakout year for Otonomy as we made
significant progress on the clinical, corporate and financial
fronts. We successfully completed Phase 3 trials for AuriPro,
expanded our management team to support our transition to a
commercial enterprise and secured significant funding with our
successful IPO," said David A. Weber, Ph.D., chief executive
officer and president of Otonomy. "I expect this year to be equally
noteworthy given our recent follow-on offering and AuriPro NDA
submission, as well as significant upcoming milestones including
Phase 2b results for OTO-104 in Ménière's disease and planned
initiation of clinical trials for both AuriPro and OTO-311."
Anticipated Upcoming Milestones
- Results for the OTO-104 Phase 2b trial in Ménière's disease
patients are expected during the second quarter of 2015.
- Initiation of a clinical trial for AuriPro in one or more
additional indications expected to begin in the first half of 2015.
- Investigational New Drug (IND) filing and initiation of a Phase
1 clinical trial for OTO-311, a potential treatment for tinnitus,
is expected in 2015.
Fourth Quarter and Full Year 2014 Financial
Highlights
- Cash, cash equivalents, and short-term investments totaled
$156.0 million as of December 31, 2014, compared with $37.3 million
as of December 31, 2013. In addition, Otonomy completed a follow-on
public offering in January 2015 that provided proceeds of
approximately $80 million net of underwriting discounts,
commissions and offering-related transaction costs.
- Operating expenses totaled $9.9 million for the fourth quarter
of 2014 compared to operating expenses of $7.9 million for the
fourth quarter of 2013. For the full year 2014, operating expenses
totaled $39.6 million compared to $19.8 million for 2013.
- Research and development expenses for the fourth quarter of
2014 were $7.2 million, compared with $6.6 million for the fourth
quarter of 2013. The increase was primarily a result of additional
clinical trial-related expenses for OTO-104. For the full year
2014, research and development expenses were $31.8 million compared
to $16.3 million for 2013.
- General and administrative expenses for the fourth quarter of
2014 were $2.7 million, compared to $1.2 million for the fourth
quarter of 2013. The increase was primarily attributable to
expanded operating activities, costs related to commercial
preparation activities and costs associated with becoming a
publicly traded company. For the full year 2014, general and
administrative expenses were $7.8 million compared to $3.5 million
for 2013.
- Net loss for the fourth quarter of 2014 was $9.8 million,
compared to net loss of $7.8 million for the fourth quarter of
2013. For the full year 2014, net loss was $42.9 million compared
to $19.6 million for 2013.
- Management expects operating expenses for 2015 to be in the
range of $70-$75 million.
Conference Call and Webcast
Otonomy management will host a webcast and conference call
regarding this announcement at 4:30 p.m. ET/1:30 p.m. PT today. The
live call may be accessed by dialing (866) 953-6857 for domestic
callers and (617) 399-3481 for international callers with
conference code number: 61228517. A live webcast and archive of the
call will be available from the investor relations section of the
company website at www.otonomy.com. A telephone replay of the call
will be available by dialing (888) 286-8010 for domestic callers or
(617) 801-6888 for international callers and entering the
conference code number: 90772974.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on
the development and commercialization of innovative therapeutics
for diseases and disorders of the ear. Otonomy's proprietary
technology provides sustained exposure of drugs to the middle and
inner ear following a single intratympanic injection. Otonomy has
three product candidates in development. AuriPro™ is an antibiotic
that has completed Phase 3 clinical trials in pediatric patients
with middle ear effusion at the time of tympanostomy tube placement
surgery. A New Drug Application for AuriPro has been submitted to
the FDA. OTO-104 is a steroid that is in the first of two pivotal
clinical studies for the treatment of patients with Ménière's
disease. OTO-311 is an NMDA receptor antagonist in development as a
treatment for tinnitus. For additional information please visit
www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or Otonomy's future financial or operating performance.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the commercial
launch of AuriPro in the United States, the Phase 2b clinical trial
of OTO-104 serving as one of two pivotal, single-dose efficacy
trials required to support U.S. regulatory approval, the timing of
results from the Phase 2b clinical trial of OTO-104, the initiation
of a second pivotal trial of OTO-104, the expected enrollment for
the multiple-dose safety study of OTO-104 in the United Kingdom,
the initiation of a clinical trial for AuriPro in one or more
additional indications, the timing of an IND filing with the FDA
and initiation of a clinical trial for OTO-311, and estimated
operating expenses for 2015. Otonomy's expectations regarding these
matters may not materialize, and actual results in future periods
are subject to risks and uncertainties. Actual results may differ
materially from those indicated by these forward-looking statements
as a result of these risks and uncertainties, including but not
limited to: Otonomy's limited operating history and its expectation
that it will incur significant losses for the foreseeable future;
Otonomy's ability to obtain substantial additional financing;
Otonomy's dependence on the regulatory and commercial success of
AuriPro and OTO-104 and advancing additional product candidates,
such as OTO-311; the uncertainties inherent in the clinical drug
development process,including, without limitation, Otonomy's
ability to adequately demonstrate the safety and efficacy of its
product candidates, the preclinical and clinical results for its
product candidates, which may not support further development of
product candidates, and challenges related to patient enrollment in
clinical trials; Otonomy's ability to obtain regulatory approval
for its product candidates; side effects or adverse events
associated with Otonomy's product candidates; competition in the
biopharmaceutical industry; Otonomy's dependence on third parties
to conduct preclinical studies and clinical trials; Otonomy's
dependence on third parties for the manufacture of products;
Otonomy's dependence on a small number of suppliers for raw
materials; Otonomy's ability to protect its intellectual property
related to product candidates in the United States and throughout
the world; expectations regarding potential market size,
opportunity and growth; Otonomy's ability to manage operating
expenses; implementation of Otonomy's business model and strategic
plans for its business, products and technology;; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" in Otonomy's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (the SEC) on March 18, 2015, and Otonomy's future
reports to be filed with the SEC. The forward-looking statements in
this press release are based on information available to Otonomy as
of the date hereof. Otonomy disclaims any obligation to update any
forward-looking statements, except as required by law.
Otonomy,
Inc. |
Condensed Balance Sheet
Data |
(in
thousands) |
|
|
|
|
As of
December 31, |
|
2014 |
2013 |
|
|
|
Cash and cash equivalents |
$ 139,810 |
$ 37,284 |
|
|
|
Short-term investments |
16,223 |
-- |
|
|
|
Total assets |
159,164 |
39,757 |
|
|
|
Total liabilities |
5,551 |
3,581 |
|
|
|
Accumulated deficit |
(102,469) |
(59,557) |
|
|
|
Total stockholders' equity
(deficit) |
153,613 |
(58,977) |
|
|
|
|
|
|
Otonomy,
Inc. |
Condensed Statements of
Operations |
(in thousands, except
share and per share data) |
|
|
|
|
|
|
Three Months
Ended |
Years
Ended |
|
December 31, |
December 31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
|
|
Operating expenses: |
|
|
|
|
Research and development |
$ 7,187 |
$ 6,638 |
$ 31,803 |
$ 16,336 |
General and administrative |
2,667 |
1,230 |
7,836 |
3,514 |
Total operating expenses |
9,854 |
7,868 |
39,639 |
19,850 |
Loss from operations |
(9,854) |
(7,868) |
(39,639) |
(19,850) |
|
|
|
|
|
Other income (expense) |
60 |
111 |
(3,238) |
291 |
Net loss |
(9,794) |
(7,757) |
(42,877) |
(19,559) |
Accretion to redemption value of convertible
preferred stock |
-- |
(13) |
(35) |
(539) |
Net loss attributable to common
stockholders |
$ (9,794) |
$ (7,770) |
$ (42,912) |
$ (20,098) |
|
|
|
|
|
Net loss per share attributable to common
stockholders, basic and diluted |
$ (0.46) |
$ (103.15) |
$ (5.46) |
$ (268.79) |
|
|
|
|
|
Weighted-average shares used to compute net
loss per share attributable to common stockholders, basic and
diluted |
21,158,394 |
75,325 |
7,853,228 |
74,772 |
|
|
|
|
|
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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