Otonomy Reports First Quarter 2015 Financial Results and Provides Corporate Update
May 12 2015 - 4:01PM
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 ended
March 31, 2015 and provided an update on its corporate activities
and product pipeline.
First Quarter 2015 and Subsequent
Highlights
- Filed New Drug Application (NDA) with 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. On April 28,
2015, Otonomy announced the FDA's acceptance of the AuriPro NDA
submission for review. The FDA has assigned a Prescription Drug
User Fee Act (PDUFA) action date of December 25, 2015. If approved
by or on the PDUFA date, Otonomy expects to launch the product in
the United States during the first quarter of 2016.
- Presented Positive AuriPro Phase 3 Results at American
Society of Pediatric Otolaryngology (ASPO) Meeting: On
April 24, 2015, results of the AuriPro Phase 3 trials were the
subject of an oral presentation at the ASPO meeting, titled
"Results of Two Phase 3 Clinical Trials To Assess The Safety and
Efficacy Of Extended-Release Ciprofloxacin Gel For Intratympanic
Administration In Children With Middle Ear Effusion Undergoing
Tympanostomy Tube Placement."
- Initiated and Completed Enrollment in Phase 2 Clinical
Trial for AuriPro in Label Expansion Indication: In March
2015, Otonomy announced the enrollment of the first patients in a
Phase 2 clinical trial evaluating AuriPro for the treatment of
pediatric patients with acute otitis media with tympanostomy tubes
(AOMT), and in May 2015, Otonomy announced the completion of
enrollment in the trial. The one-month, prospective, multicenter,
open-label trial enrolled a total of 39 pediatric patients in the
United States and the initial results demonstrated feasibility of
AuriPro use in AOMT.
- Completed Enrollment of OTO-104 Multiple-Dose Safety
Study in Ménière's Disease: On April 20, 2015, Otonomy
announced the completion of enrollment in a multiple-dose safety
study of OTO-104 in patients with Ménière's disease. This
prospective, randomized, placebo-controlled study is designed to
evaluate the safety of quarterly dosing of OTO-104. The study
enrolled a total of 128 Ménière's patients across multiple trial
sites in the United Kingdom.
- Appointed Dean Hakanson, M.D., as Chief Medical
Officer: On April 1, 2015, Otonomy announced the
appointment of Dean Hakanson, M.D., as chief medical officer. Dr.
Hakanson has more than 16 years of industry experience in medical
affairs, market access and health economic research with leading
pharmaceutical companies including Novartis, Bristol-Myers Squibb,
Genentech and GlaxoSmithKline.
- Appointed George J. Morrow as Director: On
April 30, 2015, Otonomy announced the appointment of George J.
Morrow to the Board of Directors. Mr. Morrow has extensive
experience in pharmaceutical sales and marketing. He led global
commercial operations at Amgen for nearly a decade, held senior
level commercial roles for nearly 10 years at GlaxoSmithKline and
its subsidiaries including president and CEO of Glaxo Wellcome
Inc., and served in various sales and marketing positions of
increasing responsibility during 11 years at Merck.
- 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. Net proceeds from the
follow-on offering were approximately $80 million.
- Requested Patent Interference Proceeding with
USPTO: In April 2015, Otonomy filed a Suggestion of
Interference with the United States Patent and Trademark Office
(USPTO) related to one of Otonomy's patent applications and a
patent application assigned to Auris Medical Holding AG. This
action does not involve issued U.S. patents covering Otonomy's
product candidates but is intended to support Otonomy's strategy to
broadly protect sustained-exposure drug delivery to the ear.
- Entered Lease Agreement for New Headquarters
Facility: In May 2015, Otonomy entered into a lease
agreement with ARE-SD Region No. 34, LLC for the lease of an
approximately 61,755 square foot building to be constructed at 4796
Executive Drive, San Diego, California. The new building will
accommodate growth of the Otonomy team to support commercialization
efforts and development of an expanding product pipeline. The lease
provides for the landlord to construct the building at its cost and
to use reasonable efforts to complete the building in October
2016.
"It has been a busy and highly productive start to the year for
Otonomy as evidenced by our filing and acceptance of the AuriPro
NDA ahead of schedule, the initiation and completion of a clinical
trial demonstrating the feasibility of AuriPro use for a label
expansion indication, and the completion of enrollment in a study
that will provide multiple-dose safety data for OTO-104 in
Ménière's disease patients," said David A. Weber, Ph.D., president
and CEO of Otonomy. "We have also made significant strides in
preparing for our transition to a commercial enterprise by making
key appointments to both our management team and Board of
Directors. Looking forward, we expect important news flow in the
second quarter of 2015 including results from our Phase 2b clinical
trial for OTO-104 in Ménière's disease patients."
Anticipated Upcoming Milestones
- Results from the OTO-104 Phase 2b clinical trial in Ménière's
disease patients are expected during the second quarter of 2015. If
results are positive, Otonomy intends to initiate a second pivotal
trial of OTO-104 in Ménière's disease patients in 2015.
- Initiation of a clinical trial for AuriPro in a second
potential expansion indication is expected in 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.
First Quarter Financial Highlights
- Cash, cash equivalents, and short-term investments totaled
$223.6 million as of March 31, 2015, compared with $156.0 million
as of December 31, 2014. This includes proceeds from the January
2015 follow-on public offering totaling approximately $80.0
million, net of underwriting discounts, commissions and
offering-related transaction costs.
- Operating expenses totaled $12.1 million for the first quarter
of 2015 compared to operating expenses of $10.6 million for the
first quarter of 2014.
- Research and development expenses for the first quarter of 2015
were $8.6 million, compared with $9.0 million for the first quarter
of 2014. The decrease was primarily a result of lower clinical
trial-related expenses for AuriPro following the completion of two
Phase 3 clinical trials during the second half of 2014, partially
offset by increased preclinical development expenses for OTO-311, a
$1.0 million development milestone that was met when the AuriPro
NDA was submitted to the FDA in February 2015, increased personnel
costs and increased clinical trial-related expenses for OTO-104.
- General and administrative expenses for the first quarter of
2015 were $3.5 million, compared to $1.6 million for the first
quarter of 2014. The increase was primarily attributable to
expanded operating activities, costs related to commercial
preparation activities and costs associated with becoming a
publicly traded company.
- Net loss for the first quarter of 2015 was $12.0 million,
compared to net loss of $10.8 million for the first quarter of
2014.
- Management continues to expect operating expenses for 2015 to
be in the range of $70-$75 million.
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, and a New Drug Application for AuriPro in this indication
has been filed with 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 timing of results from
the Phase 2b clinical trial of OTO-104, the initiation of a second
pivotal trial of OTO-104, the initiation of a clinical trial for
AuriPro in a second potential expansion indication, the timing of
an IND filing with the FDA and initiation of a Phase 1 clinical
trial for OTO-311, estimated operating expenses for 2015,Otonomy's
chief executive officer's statement regarding the second quarter of
2015, and Otonomy's new headquarters facility. 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 Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the SEC) on May 12, 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 Statements of
Operations |
(in thousands, except
share and per share data) |
|
|
|
|
Three Months
Ended |
|
March
31, |
|
2015 |
2014 |
|
(unaudited) |
Operating expenses: |
|
|
Research and development |
$ 8,607 |
$ 8,991 |
General and administrative |
3,501 |
1,565 |
Total operating expenses |
12,108 |
10,556 |
Loss from operations |
(12,108) |
(10,556) |
|
|
|
Other income (expense) |
91 |
(265) |
Net loss |
(12,017) |
(10,821) |
Accretion to redemption value of convertible
preferred stock |
-- |
(13) |
Net loss attributable to common
stockholders |
$ (12,017) |
$ (10,834) |
|
|
|
Net loss per share attributable to common
stockholders, basic and diluted |
$ (0.52) |
$ (129.52) |
|
|
|
Weighted-average shares used to compute net
loss per share attributable to common stockholders, basic and
diluted |
23,196,011 |
83,649 |
|
|
|
Otonomy,
Inc. |
Condensed Balance Sheet
Data |
(in
thousands) |
|
|
|
|
As of March 31, |
As of December 31, |
|
2015 |
2014 |
|
(unaudited) |
|
|
|
|
Cash and cash equivalents |
$ 201,042 |
$ 139,810 |
|
|
|
Short-term investments |
22,560 |
16,223 |
|
|
|
Total assets |
230,016 |
159,164 |
|
|
|
Total liabilities |
6,999 |
5,551 |
|
|
|
Accumulated deficit |
(114,486) |
(102,469) |
|
|
|
Total stockholders' equity |
223,017 |
153,613 |
CONTACT: Media Inquiries
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Heidi Chokeir, Ph.D.
Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
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Managing Director
858.356.5932
robert.uhl@westwicke.com
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