Otonomy Reports Third Quarter 2018 Financial Results and Provides Corporate Update
November 05 2018 - 4:12PM
Conference call and webcast today at 4:30
p.m. EST
Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
otology, today reported financial results for the quarter ended
September 30, 2018 and provided an update on its corporate
activities and product pipeline including a review of the OTO-413
program recently selected as a "Hot Topic" at the Society for
Neuroscience Annual Meeting.
Third Quarter 2018 and Subsequent
Highlights
- Announced Multiple Presentations at Society for
Neuroscience Annual Meeting and Selection of OTO-413 Presentation
as "Hot Topic": Otonomy recently announced multiple
presentations related to the company's programs in hearing loss and
tinnitus at the Society for Neuroscience Annual Meeting being held
from November 3-7 in San Diego. This includes two presentations
demonstrating the therapeutic potential of OTO-413, a
sustained-exposure formulation of brain-derived neurotrophic factor
(BDNF), for the repair of cochlear synaptopathy, and a single
presentation related to OTO-313, a sustained-exposure formulation
of gacyclidine in development for tinnitus. One of the OTO-413
presentations was selected as a Neuroscience 2018 Hot Topic.
Otonomy expects to initiate a Phase 1/2 clinical trial for OTO-413
in patients with speech-in-noise hearing difficulty and a Phase 1/2
clinical trial for OTO-313 in tinnitus patients in the first half
of 2019.
- Attended a Patient-Focused Drug Development (PFDD)
Workshop on Chemotherapy-Induced Hearing Loss (CIHL) in Pediatric
Oncology: In September 2018, Otonomy attended and helped
sponsor a PFDD workshop on pediatric CIHL organized by patient
advocates that included participation from members of the Oncology
Center of Excellence at the U.S. Food and Drug Administration
(FDA). Presentations by patients and parents highlighted the
significant negative impact of CIHL on the lives of children and
the need for a therapeutic that provides otoprotection without
tumor protection. Otonomy expects to select a clinical candidate
for its OTO-5XX CIHL otoprotection program by end of 2018 to
address this important unmet medical need.
- Initiated Phase 3 Trial for
OTIVIDEX™ in Ménière’s
Disease: In July 2018, Otonomy announced initiation of the
additional Phase 3 trial required to support submission for U.S.
registration of OTIVIDEX in Ménière’s disease. The design and
conduct of this pivotal trial, which will enroll approximately 160
patients, is based on the successful AVERTS-2 Phase 3 trial.
Otonomy expects top-line results in the first half of 2020.
- Presented Results from OTIVIDEX AVERTS-2 Trial at
International Otolaryngology Conference: In September
2018, Mr. John Phillips, FRCS (ORL-HNS), Consultant
Otolaryngologist at Norfolk & Norwich University Hospitals in
the United Kingdom, presented positive results from the AVERTS-2
Phase 3 trial of OTIVIDEX in Ménière’s disease at the annual
meeting of the American Academy of Otolaryngology - Head and Neck
Surgery Foundation. The AVERTS-2 trial achieved its primary
endpoint, count of definitive vertigo days (DVD) by Poisson
Regression analysis in Month 3 (p value = 0.029), based on analysis
of all 174 patients enrolled in the trial.
- Completed Co-Promotion Partnership for
OTIPRIO® in Acute Otitis
Externa: In August 2018, Otonomy
announced the signing of a co-promotion agreement with Mission
Pharmacal, a well-established privately held pharmaceutical
company, that provides Mission with an exclusive right to promote
OTIPRIO for acute otitis externa (AOE) in pediatrician and primary
care physician offices as well as urgent care clinics in the United
States. This agreement is expected to generate positive cashflow
for Otonomy, which retains all commercial rights for other OTIPRIO
indications and customer segments.
- Obtained Favorable Ruling in Patent Interference
Case: Although not involving issued patents covering
OTIPRIO or the company's product candidates, Otonomy filed a
request for interference in April 2015 against a U.S. patent
application controlled by Auris Medical Holding in order to broadly
protect the company's technology in the field of sustained-exposure
otic drug delivery. Otonomy appealed an initial ruling by the
Patent Trial and Appeal Board, and in August 2018, the Federal
Circuit Court issued a final ruling in Otonomy’s favor.
“The selection of our OTO-413 presentation as a Hot Topic at the
2018 Society for Neuroscience Annual Meeting and the recent
workshop on pediatric CIHL highlight the important unmet medical
need addressed by our hearing loss programs,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “When taken together with our
OTIVIDEX Phase 3 program for Ménière’s disease and OTO-313 program
for tinnitus, we have the broadest product pipeline addressing the
largest market opportunities in the untapped neurotology field. I
look forward to further discussing our pipeline and upcoming
milestones with investors in the coming months beginning with our
review of the OTO-413 program on today's call."
Anticipated Upcoming Milestones
- By the end of 2018, select a candidate for clinical development
for both OTO-5XX and OTO-6XX hearing loss programs.
- In first half of 2019, initiate a Phase 1/2 clinical trial of
OTO-313 in tinnitus patients.
- In first half of 2019, initiate a Phase 1/2 clinical trial of
OTO-413 in hearing loss patients.
Third Quarter Financial Highlights
- Cash Position: Cash, cash equivalents, and
short-term investments totaled $92.6 million as of September 30,
2018, compared to $120.0 million as of December 31, 2017.
- Operating Expenses: GAAP operating expenses
were $13.1 million for the third quarter of 2018, compared to $21.6
million for the third quarter of 2017. Non-GAAP operating expenses,
which exclude stock-based compensation and rent abatement expense,
were $10.1 million for the third quarter of 2018, compared to $17.4
million for the third quarter of 2017.
- Research and Development Expenses: GAAP
research and development (R&D) expenses for the third quarter
of 2018 were $8.3 million, compared to $10.8 million for the third
quarter of 2017. The decrease was primarily a result of decreased
clinical trial activities for OTIVIDEX versus the prior year
period.
- Selling, General and Administrative Expenses:
GAAP selling, general and administrative (SG&A) expenses in the
third quarter of 2018 were $4.7 million, compared to $10.5 million
for the third quarter of 2017. The decrease was primarily a result
of reduced selling expenses due to the discontinuation of
promotional support for OTIPRIO.
- Financial Guidance: Otonomy reaffirms its
expectations that GAAP operating expenses for 2018 will be in the
range of $52-$57 million, and that non-GAAP operating expenses for
2018 will be in the range of $40-$45 million.
Webcast and Conference Call
Otonomy management will host a webcast and conference call
regarding this announcement at 4:30 p.m. EST/1:30 p.m. PST today.
The live call may be accessed by dialing (877) 305-6769 for
domestic callers and (678) 562-4239 for international callers with
conference ID code number: 9792838. A live webcast of the call will
be available online in the investor relations section of Otonomy’s
website at www.otonomy.com and will be archived there for 30
days.
Non-GAAP Operating Expenses
In this press release, Otonomy’s operating expenses are provided
in accordance with generally accepted accounting principles (GAAP)
in the United States and also on a non-GAAP basis. Non-GAAP
operating expenses exclude stock-based compensation and rent
abatement expense. Non-GAAP operating expenses are provided as a
complement to operating expenses provided in accordance with GAAP
because management believes non-GAAP operating expenses help
indicate underlying trends in the company’s business, are important
in comparing current results with prior period results and provide
additional information regarding the company’s financial position.
Management also uses non-GAAP operating expenses to establish
budgets and operational goals that are communicated internally and
externally and to manage the company’s business and to evaluate its
performance. The attached financial information includes a
reconciliation of the GAAP operating expenses to non-GAAP operating
expenses and a reconciliation of GAAP operating expense guidance to
non-GAAP operating expense guidance.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the
development of innovative therapeutics for otology. The company
pioneered the application of drug delivery technology to the ear in
order to develop products that achieve sustained drug exposure from
a single local administration. This approach is covered by a broad
patent estate and is being utilized to develop a pipeline of
products addressing important unmet medical needs including
Ménière’s disease, hearing loss, and 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 the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, the potential benefits of the co-promotion
agreement between Otonomy and Mission, timing of top-line results
and patient recruitment and enrollment plans for the Phase 3 trial
for OTIVIDEX, timing of a Phase 1/2 clinical trial for OTO-313,
timing of a Phase 1/2 clinical trial for OTO-413, timing of
candidate selection for OTO-5XX and OTO-6XX programs, financial
guidance for 2018, and statements by Otonomy’s president and CEO.
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 additional financing; Otonomy’s dependence on the regulatory
success and advancement of its product candidates; 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
nonclinical and clinical results for its product candidates, which
may not support further development, and challenges related to
patient enrollment in clinical trials; Otonomy’s ability to obtain
regulatory approval for its product candidates; the risks of the
occurrence of any event, change or other circumstance that could
give rise to the termination of the co-promotion agreement between
Otonomy and Mission; side effects or adverse events associated with
Otonomy’s product candidates; Otonomy’s ability to successfully
commercialize its product candidates, if approved; competition in
the biopharmaceutical industry; Otonomy’s dependence on third
parties to conduct nonclinical studies and clinical trials;
Otonomy’s dependence on third parties for the manufacture of its
product candidates; Otonomy’s dependence on a small number of
suppliers for raw materials; Otonomy’s ability to protect its
intellectual property related to its 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 November 5, 2018,
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.
Contacts:
Media InquiriesSpectrum ScienceLeticia DiazVice President
202.587.2517ldiaz@spectrumscience.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
|
Otonomy,
Inc. |
Condensed Balance Sheet Data |
(in thousands) |
|
|
|
|
|
As of September
30, |
|
As of December
31, |
|
2018 |
|
2017 |
|
(unaudited) |
|
|
Cash and cash
equivalents |
$ |
21,382 |
|
|
$ |
18,456 |
|
|
|
|
|
Short-term
investments |
|
71,180 |
|
|
|
101,548 |
|
|
|
|
|
Total assets |
|
100,215 |
|
|
|
128,364 |
|
|
|
|
|
Total liabilities |
|
10,217 |
|
|
|
11,085 |
|
|
|
|
|
Accumulated
deficit |
|
(402,373 |
) |
|
|
(364,850 |
) |
|
|
|
|
Total stockholders' equity |
|
89,998 |
|
|
|
117,279 |
|
|
|
|
|
|
Otonomy,
Inc. |
Condensed Statements of
Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September
30, |
|
September
30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
(unaudited) |
Product sales, net |
$ |
113 |
|
|
$ |
282 |
|
|
$ |
537 |
|
|
$ |
966 |
|
Costs and operating
expenses: |
|
|
|
|
|
|
|
Cost of
product sales |
|
162 |
|
|
|
290 |
|
|
|
675 |
|
|
|
1,150 |
|
Research
and development |
|
8,300 |
|
|
|
10,761 |
|
|
|
22,175 |
|
|
|
36,660 |
|
Selling,
general and administrative |
|
4,652 |
|
|
|
10,548 |
|
|
|
16,428 |
|
|
|
35,387 |
|
Total costs and
operating expenses |
|
13,114 |
|
|
|
21,599 |
|
|
|
39,278 |
|
|
|
73,197 |
|
Loss from
operations |
|
(13,001 |
) |
|
|
(21,317 |
) |
|
|
(38,741 |
) |
|
|
(72,231 |
) |
|
|
|
|
|
|
|
|
Interest income |
|
455 |
|
|
|
319 |
|
|
|
1,218 |
|
|
|
934 |
|
Net loss |
$ |
(12,546 |
) |
|
$ |
(20,998 |
) |
|
$ |
(37,523 |
) |
|
$ |
(71,297 |
) |
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.41 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.23 |
) |
|
$ |
(2.35 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
used to compute net loss per share, |
|
|
|
|
|
|
|
basic and
diluted |
|
30,630,125 |
|
|
|
30,314,155 |
|
|
|
30,597,874 |
|
|
|
30,280,267 |
|
|
|
|
|
|
|
|
|
|
Otonomy,
Inc. |
Reconciliation of GAAP to Non-GAAP Operating
Expenses |
(in thousands) |
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September
30, |
|
September
30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
(unaudited) |
GAAP operating
expenses |
|
|
|
|
|
|
|
Research
and development |
$ |
8,300 |
|
|
$ |
10,761 |
|
|
$ |
22,175 |
|
|
$ |
36,660 |
|
Selling,
general and administrative |
|
4,652 |
|
|
|
10,548 |
|
|
|
16,428 |
|
|
|
35,387 |
|
Total GAAP operating
expenses |
|
12,952 |
|
|
|
21,309 |
|
|
|
38,603 |
|
|
|
72,047 |
|
Non-GAAP
adjustments |
|
|
|
|
|
|
|
R&D
stock-based compensation expense |
|
(1,037 |
) |
|
|
(823 |
) |
|
|
(3,372 |
) |
|
|
(3,167 |
) |
SG&A
stock-based compensation expense |
|
(1,770 |
) |
|
|
(2,424 |
) |
|
|
(6,580 |
) |
|
|
(7,285 |
) |
Rent
abatement |
|
- |
|
|
|
(695 |
) |
|
|
- |
|
|
|
(2,084 |
) |
Total non-GAAP
adjustments |
|
(2,807 |
) |
|
|
(3,942 |
) |
|
|
(9,952 |
) |
|
|
(12,536 |
) |
Non-GAAP operating
expenses |
$ |
10,145 |
|
|
$ |
17,367 |
|
|
$ |
28,651 |
|
|
$ |
59,511 |
|
|
|
|
|
|
|
|
|
|
Otonomy,
Inc. |
Reconciliation of 2018 GAAP to Non-GAAP
Operating Expense Guidance |
(in millions) |
|
|
|
|
GAAP operating
expenses |
$52 -
$57 |
Non-GAAP
adjustments |
|
Stock-based compensation expense |
12 |
Non-GAAP operating
expenses |
$40 - $45 |
|
|
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