Otonomy Reports Second Quarter 2016 Financial Results and Provides Corporate Update
August 04 2016 - 4:09PM
Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics for diseases and disorders of the ear, today reported
financial results for the quarter ended June 30, 2016 and provided
an update on its corporate activities and product pipeline.
Second Quarter 2016 and Subsequent
Highlights
- OTIPRIO™ Launch Update: In March 2016, Otonomy
announced the commercial availability of OTIPRIO (ciprofloxacin
otic suspension) in the United States for the treatment of
pediatric patients with bilateral otitis media with effusion
undergoing tympanostomy tube placement (TTP). For 2016 Otonomy's
commercial effort is focused on building awareness and advocacy for
OTIPRIO with physicians, gaining formulary approval in target
facilities, and establishing reimbursement. These efforts require
contact and coordination with multiple stakeholders including
physicians, hospital pharmacists, facility administrators, and
payors. A typical review by a hospital pharmacy and therapeutics
(P&T) committee can take six to nine months to complete and is
essential before utilization of OTIPRIO can begin in a given
institution. We completed this process with a limited number of
facilities through the second quarter which is reflected in the
minimal revenues.Commercial launch highlights through July include:
- The Centers for Medicare and Medicaid Services (CMS) approved
transitional pass-through status and established a new billing code
for OTIPRIO. The code, C9479, became effective July 1, 2016.
Hospital outpatient departments and ambulatory surgery centers
billing for drugs assigned a C code are eligible for payment by
Medicare for the pass-through drug in addition to the fee received
by the facility for the related procedure. Otonomy believes that
other payors including Medicaid and commercial insurers will, in
many instances, follow Medicare’s lead.
- Otonomy has made one or more OTIPRIO presentations to 90% of
the top 100 target physicians, 85% of the top 500, and
approximately 80% of the 2,000 physicians in its target
audience.
- Approximately 400 physicians who are affiliated with more than
650 facilities have received OTIPRIO for use during TTP surgery
through Otonomy's distribution of product samples.
- OTIPRIO has now received formulary approval in more than 110
hospitals and reviews in an additional 240 hospitals are already
scheduled. Otonomy's success rate for formulary approval is
currently over 90% in target hospitals, demonstrating the
importance of Otonomy's methodical, multiple stakeholder
approach.
- Approximately 75 facilities have now purchased OTIPRIO, of
which 40% have placed multiple orders.
- Collectively, the facilities that have purchased OTIPRIO, have
formulary approvals or scheduled reviews, or are affiliated with
physicians who have received product samples, account for more than
one-third of total TTP volume in the United States.
- Otonomy has had introductory discussions with 14 of the largest
20 commercial payors that represent over 125 million covered lives,
and has had initial contact with all of the state Medicaid
programs. Based on these discussions, the company believes that
there will be limited restrictions placed by payors on the use of
OTIPRIO during TTP surgery and there will be an opportunity for
many facilities to receive reimbursement for OTIPRIO in addition to
the TTP procedure payment.
- Initiated Phase 3 Registration Trial of OTIPRIO in
Acute Otitis Externa: In June 2016, Otonomy announced
enrollment of the first patient in a Phase 3 clinical trial in
pediatric and adult patients with acute otitis externa, also known
as swimmer’s ear. The company expects to complete this trial and
report topline results in the fourth quarter of 2016. If the
results are positive, Otonomy expects to submit a supplemental New
Drug Application (sNDA) to the U.S. Food and Drug Administration
(FDA) in the first half of 2017.
- Completed Patient Enrollment in an Open Label Phase 3b
Clinical Trial of OTIPRIO in Expanded Population of Pediatric
Patients Undergoing TTP Surgery: During the second
quarter, Otonomy completed enrollment in an open label Phase 3b
clinical trial that enrolled 501 pediatric patients undergoing TTP
surgery. This trial is designed to evaluate OTIPRIO in a broader
pediatric patient population than the previous Phase 3 trials by
including patients undergoing common concurrent surgeries, and
patients without bilateral effusion on the day of surgery. In
addition, this study includes an extended follow-up observation
period of 2 months and is designed to assess a novel Ear Drop
Caregiver Burden Questionnaire in those patients requiring
treatment with antibiotic ear drops. Topline results are expected
to be available in the third quarter of 2016.
- Completed Patient Enrollment in a Phase 2 Clinical
Trial of OTIPRIO in Pediatric Patients with Acute Otitis Media with
Tympanostomy Tubes (AOMT): In June 2016, Otonomy completed
patient enrollment in a Phase 2 clinical trial evaluating a single
administration of OTIPRIO for the treatment of pediatric patients
with AOMT. A total of 95 pediatric patients were enrolled in this
trial which is intended to determine the appropriate dose for
further development of OTIPRIO in this indication. Topline results
are expected to be available in the fourth quarter of
2016.
- OTIPRIO Data Presentation and Symposium Held at a
National ENT Conference: In May 2016 at the Combined
Otolaryngology Spring Meetings (COSM), Otonomy presented data from
a Phase 3b clinical trial that demonstrated the feasibility of
administering OTIPRIO through the tube during a TTP procedure. In
the Phase 3 clinical trials, OTIPRIO was administered prior to tube
placement. Otonomy’s Medical Affairs group also sponsored a
symposium for conference attendees which included a live
demonstration of OTIPRIO’s thermosensitive properties.
- Enrollment in AVERTS-1 and AVERTS-2 Phase 3 Clinical
Trials for OTO-104 in Ménière’s Disease is Ongoing:
Otonomy is conducting two Phase 3 trials for OTO-104 in patients
with Ménière’s disease, AVERTS-1 in the United States and AVERTS-2
in the European Union (AVERTS = Alleviation of Vertigo Episodes
Study). Each trial is a 16-week, prospective, randomized,
double-blind, placebo-controlled trial that will enroll
approximately 160 patients with unilateral Ménière’s disease.
Results of both Phase 3 trials are expected in the second half of
2017. Patients completing AVERTS-1 and AVERTS-2 will be eligible to
participate in an open label, multiple-dose safety study where they
can receive two quarterly doses of OTO-104. OTO-104 has been
granted Fast Track designation for this indication by the FDA.
- Successfully Completed One-Year, Multiple-Dose Clinical
Safety Trial for OTO-104 in Ménière’s Disease Patients: In
August 2016, Otonomy announced the successful completion of a
one-year, multiple-dose clinical safety trial of OTO-104 in
patients with Ménière’s disease. This prospective, randomized,
placebo-controlled clinical safety trial enrolled a total of 128
patients across multiple trial sites in the United Kingdom and
demonstrated that quarterly dosing of OTO-104 was well tolerated. A
multiple-dose clinical safety trial was initiated in Canada in the
second quarter of 2016 to provide additional patients to meet the
registration requirements for one-year repeat dose
safety.
- Phase 1 Clinical Safety Trial of OTO-311 is
Ongoing: OTO-311 is a single-dose, sustained-exposure
formulation of the potent and selective N-Methyl-D-Aspartate (NMDA)
receptor antagonist gacyclidine that is in development for the
treatment of tinnitus. Several dose cohorts in the Phase 1 clinical
safety trial have been completed without concerns of patient
tolerability. The trial will remain open in the second half of 2016
pending the potential evaluation of additional dose levels.
“Throughout 2016, we will remain focused on laying the
foundation for OTIPRIO by establishing broad awareness within the
target physician audience and successfully building advocacy
through the sample trial program. The first quarter of launch has
provided us with valuable experience in gaining formulary
acceptance which we believe will be supported by the assignment of
a unique C code for OTIPRIO that was effective as of July 1,” said
David A. Weber, Ph.D., president and CEO of Otonomy. “In addition
to our commercial execution, we continue to advance our product
development programs as evidenced by the timely initiation of the
Phase 3 trial for OTIPRIO in acute otitis externa, completion of
patient enrollment in both the Phase 3b TTP and Phase 2 AOMT trials
for OTIPRIO, and ongoing progress of the OTO-104 AVERTS-1 and
AVERTS-2 Phase 3 clinical trials in Ménière’s disease.”
Anticipated Upcoming Milestones
- Announcement of topline results for the Phase 3b trial of
OTIPRIO in expanded pediatric patient population undergoing TTP
surgery is expected in the third quarter of 2016.
- Announcement of topline results for the Phase 2 clinical trial
of OTIPRIO in AOMT is expected in the fourth quarter of
2016.
- Completion of a Phase 3 registration trial of OTIPRIO in acute
otitis externa and announcement of topline results is expected in
the fourth quarter of 2016.
- Initiation of a Phase 2 feasibility trial for OTO-104 in
pediatric patients undergoing cisplatin chemotherapy treatment is
expected in the second half of 2016.
Board of Directors and Management Team
Updates
- Resignation of Chau Q. Khuong from Board of
Directors: On July 29, 2016, Chau Q. Khuong resigned from
Otonomy’s board of directors and from his positions on the audit
and compensation committees in order to devote additional attention
to his responsibilities as a private equity partner at OrbiMed
Advisors. The decision of Mr. Khuong to resign is not the result of
any disagreement with the company on any matter relating to its
operations, policies or practices.
- Appointment of Iain McGill to Board of
Directors: On August 2, 2016, Otonomy appointed Iain
McGill to the board of directors and to the audit committee. Mr.
McGill has served as senior vice president, Jazz Pharmaceuticals
Europe and Rest of World for Jazz Pharmaceuticals PLC since March
2015. In this role, he has responsibility for all ex-U.S.
operations and leads a multidisciplinary team covering commercial,
development, medical, legal, compliance, business development and
finance. From March 2014 to March 2015, Mr. McGill served as head
of EUSA Pharma and senior vice president, Jazz Pharmaceuticals, and
as chief commercial officer, EUSA Pharma, a specialty
pharmaceutical company, from June 2012 to March 2014, when he
joined Jazz Pharmaceuticals in connection with its acquisition of
EUSA Pharma. From October 2011 to June 2012, Mr. McGill served
as chief commercial officer at EUSA Pharma (Europe) Ltd. From
August 2010 to September 2011, he served as president Europe,
international & global marketing of EUSA Pharma (Europe) Ltd,
and from January 2010 to July 2010, as president of
Europe. From 2006 to 2009, Mr. McGill served as vice president
and global business manager at Wyeth, a pharmaceutical company
acquired by Pfizer Inc. Previously, Mr. McGill held commercial
positions of increasing responsibility over thirteen years with
Novartis, Roche and Syntex. He holds a Bachelor of Science degree
in Biochemistry from the University of London.
- Retirement of Chief Scientific Officer:
Otonomy’s chief scientific officer, Carl LeBel, Ph.D., has informed
the company of his plan to retire from full-time employment. Dr.
LeBel will continue in a full-time capacity until his replacement
has been hired plus an additional transition period. After that,
Dr. LeBel has committed to provide consulting support for an
extended period. The company has initiated a search for a suitable
replacement.
“I am delighted to welcome Iain to the board and believe that
Otonomy will benefit greatly from his broad international
pharmaceutical experience as we define our strategy for the
development and commercialization of our product pipeline in
markets outside the United States,” added Dr. Weber. “I would also
like to take this opportunity to express my sincere gratitude and
appreciation for the service and contributions made by both Carl
and Chau. As one of Otonomy’s early employees, Carl played a key
role in establishing the company’s development group and
capabilities, and his commitment to support a smooth transition and
serve in a part-time consulting role over an extended period
clearly demonstrates his dedication to the success of Otonomy.
Likewise, Chau’s active participation and thoughtful contributions
and guidance to the company and its board through our initial
public offering and transition to a commercial-stage company have
been greatly appreciated.”
Second Quarter Financial Highlights
- Cash Position: Cash, cash equivalents, and
short-term investments totaled $239.0 million as of June 30, 2016,
compared to $184.8 million as of December 31, 2015.
- Operating Expenses: GAAP operating expenses
were $30.0 million for the second quarter of 2016, compared to
$12.6 million for the second quarter of 2015. Non-GAAP operating
expenses, which exclude stock-based compensation and depreciation
expense, were $26.6 million for the second quarter of 2016,
compared to $10.8 million for the second quarter of 2015.
- Research and Development Expenses: GAAP
research and development (R&D) expenses for the second quarter
of 2016 were $16.7 million, compared to $7.3 million for the second
quarter of 2015. The increase was primarily a result of clinical
expenses for OTIPRIO related to the open-label Phase 3b clinical
trial initiated in late 2015 and label expansion trials initiated
during the first half of 2016 as well as clinical expenses for
OTO-104 related to the AVERTS-1 and AVERTS-2 trials initiated in
the fourth quarter of 2015 and first quarter of 2016, respectively.
R&D-related stock-based compensation expense was $0.8 million
for the second quarter of 2016, compared to $0.7 million for the
second quarter of 2015.
- Selling, General and Administrative Expenses:
GAAP selling, general and administrative (SG&A) expenses in the
second quarter of 2016 were $12.9 million, compared to $5.3 million
for the second quarter of 2015. The increase was primarily
attributable to increased personnel expense and operating costs
related to the commercial launch of OTIPRIO. SG&A-related
stock-based compensation expense was $2.4 million for the second
quarter of 2016, compared to $1.0 million for the second quarter of
2015.
- Financial Guidance: The company reaffirms its
expectation that non-GAAP operating expenses for 2016 will total
$100-$105 million.
Non-GAAP Financial Measures
In this press release, Otonomy’s financial results are provided
in accordance with generally accepted accounting principles (GAAP)
in the United States and also on a non-GAAP basis. Non-GAAP
financial results exclude stock-based compensation and depreciation
expense. These non-GAAP results are provided as a complement to
results provided in accordance with GAAP because management
believes these non-GAAP financial measures 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 these non-GAAP financial measures to establish budgets
and operational goals that are communicated internally and
externally and to manage the company’s business and to evaluate its
performance. Otonomy is unable to provide GAAP operating expense
guidance since stock-based compensation expense is a significant
component of GAAP operating expenses and stock-based compensation
expense is difficult to predict and estimate due to its dependence
on Otonomy’s future stock price. A reconciliation of the GAAP
financial results to non-GAAP financial results is included in the
attached financial information.
About OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for the treatment of pediatric patients
with bilateral otitis media with effusion undergoing tympanostomy
tube placement. OTIPRIO is administered by a physician as a single
0.1 mL (6 mg) intratympanic administration into each affected ear,
following suctioning of the middle ear effusion. The
thermosensitive suspension exists as a liquid at or below room
temperature and gels when warmed. In two Phase 3 trials, a single
intraoperative administration of OTIPRIO demonstrated a
statistically significant reduction in the cumulative proportion of
study treatment failures compared to tubes alone (p-value
<0.001).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated
in patients with a history of hypersensitivity to ciprofloxacin, to
other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential for Microbial
Overgrowth: OTIPRIO may result in overgrowth of
nonsusceptible bacteria and fungi. If such infections occur,
institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence
at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs
sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and
rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established.
Full prescribing information can be found at
www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for
diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use during
tympanostomy tube placement surgery in pediatric patients, and
commercial launch commenced in March 2016. OTO-104 is a steroid in
development for the treatment of Ménière's disease and other severe
balance and hearing disorders. Two Phase 3 trials in Ménière's
disease patients are underway, with results expected during the
second half of 2017. OTO-311 is an NMDA receptor antagonist for the
treatment of tinnitus that is in a Phase 1 clinical safety trial.
Otonomy’s proprietary formulation technology utilizes a
thermosensitive gel and drug microparticles to enable single dose
treatment by a physician. 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 future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, the statements regarding a C code and potential
actions by Medicaid and private insurers, opportunities for
reimbursement for OTIPRIO, the timing of completion and results of
the OTIPRIO Phase 3 clinical trial for acute otitis externa, the
timing of the submission of the sNDA to the FDA for OTIPRIO for
acute otitis externa, the timing of results of the Phase 3b
clinical trial of OTIPRIO in an expanded population of pediatric
patients undergoing TTP surgery, enrollment in, and the timing of
results of, the two OTO-104 Phase 3 clinical trials for Ménière’s
disease, the timing of initiation of the OTO-104 Phase 2 clinical
trial for cisplatin-induced hearing loss, the Phase 1 clinical
safety trial of OTO-311 for treatment of tinnitus, the timing of
results of the OTIPRIO Phase 2 clinical trial for AOMT, the sample
distribution program and its potential results, the statements of
Otonomy’s president and CEO, all upcoming milestones and all
financial guidance. 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 commercial success of OTIPRIO and the regulatory
success and advancement of additional product candidates, such as
OTO-104 and OTO-311, and label expansion indications for OTIPRIO;
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, 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; the timing and outcome of
hospital pharmacy and therapeutics reviews and other facility
reviews; the impact of coverage and reimbursement decisions by
third-party payors on the pricing and market acceptance of OTIPRIO;
Otonomy's dependence on third parties for the manufacture of
OTIPRIO and product candidates; Otonomy's dependence on a small
number of suppliers for raw materials; Otonomy's ability to protect
its intellectual property related to OTIPRIO and 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 August 4, 2016, 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 June 30, |
|
As of December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
46,569 |
|
|
$ |
158,664 |
|
|
|
|
|
|
|
Short-term
investments |
|
192,451 |
|
|
|
26,172 |
|
|
|
|
|
|
|
Total assets |
|
250,452 |
|
|
|
193,030 |
|
|
|
|
|
|
|
Total liabilities |
|
11,007 |
|
|
|
11,496 |
|
|
|
|
|
|
|
Accumulated
deficit |
|
(220,576 |
) |
|
|
(164,137 |
) |
|
|
|
|
|
|
Total stockholders'
equity |
|
239,445 |
|
|
|
181,534 |
|
|
|
|
|
|
|
Otonomy, Inc. |
Condensed Statements of
Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Product
sales, net |
$ |
76 |
|
|
$ |
- |
|
|
$ |
89 |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of product
sales |
|
395 |
|
|
|
- |
|
|
|
404 |
|
|
|
- |
|
|
Research and
development |
|
16,742 |
|
|
|
7,289 |
|
|
|
30,614 |
|
|
|
15,896 |
|
|
Selling, general and
administrative |
|
12,846 |
|
|
|
5,352 |
|
|
|
25,841 |
|
|
|
8,853 |
|
Total
operating expenses |
|
29,983 |
|
|
|
12,641 |
|
|
|
56,859 |
|
|
|
24,749 |
|
Loss from
operations |
|
(29,907 |
) |
|
|
(12,641 |
) |
|
|
(56,770 |
) |
|
|
(24,749 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense) |
|
231 |
|
|
|
97 |
|
|
|
331 |
|
|
|
188 |
|
Net
loss |
$ |
(29,676 |
) |
|
$ |
(12,544 |
) |
|
$ |
(56,439 |
) |
|
$ |
(24,561 |
) |
|
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
$ |
(0.98 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.90 |
) |
|
$ |
(1.04 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used to compute net loss per share,
|
|
|
|
|
|
|
|
|
basic and diluted |
|
30,128,150 |
|
|
|
24,139,791 |
|
|
|
29,728,477 |
|
|
|
23,670,508 |
|
|
|
|
|
|
|
|
|
|
|
Otonomy, Inc. |
Reconciliation of GAAP to Non-GAAP Financial
Information |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
Reconciliation of GAAP to non-GAAP operating
expenses |
|
|
|
|
|
|
|
GAAP
operating expenses |
$ |
29,983 |
|
|
$ |
12,641 |
|
|
$ |
56,859 |
|
|
$ |
24,749 |
|
Non-GAAP
adjustments |
|
|
|
|
|
|
|
|
Cost of product sales
stock-based compensation expense |
|
(4 |
) |
|
|
- |
|
|
|
(4 |
) |
|
|
- |
|
|
R&D stock-based
compensation expense |
|
(778 |
) |
|
|
(723 |
) |
|
|
(1,425 |
) |
|
|
(1,275 |
) |
|
SG&A stock-based
compensation expense |
|
(2,444 |
) |
|
|
(1,035 |
) |
|
|
(4,533 |
) |
|
|
(1,826 |
) |
|
Depreciation
expense |
|
(168 |
) |
|
|
(64 |
) |
|
|
(320 |
) |
|
|
(124 |
) |
Total
non-GAAP adjustments |
|
(3,394 |
) |
|
|
(1,822 |
) |
|
|
(6,282 |
) |
|
|
(3,225 |
) |
Non-GAAP
operating expenses |
$ |
26,589 |
|
|
$ |
10,819 |
|
|
$ |
50,577 |
|
|
$ |
21,524 |
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to non-GAAP net loss |
|
|
|
|
|
|
|
GAAP net
loss |
$ |
(29,676 |
) |
|
$ |
(12,544 |
) |
|
$ |
(56,439 |
) |
|
$ |
(24,561 |
) |
Non-GAAP
adjustments |
|
3,394 |
|
|
|
1,822 |
|
|
|
6,282 |
|
|
|
3,225 |
|
Non-GAAP
net loss |
$ |
(26,282 |
) |
|
$ |
(10,722 |
) |
|
$ |
(50,157 |
) |
|
$ |
(21,336 |
) |
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to non-GAAP net loss per
share |
|
|
|
|
|
|
|
GAAP net
loss per share, basic and diluted |
$ |
(0.98 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.90 |
) |
|
$ |
(1.04 |
) |
Non-GAAP
adjustments |
|
0.11 |
|
|
|
0.08 |
|
|
|
0.21 |
|
|
|
0.14 |
|
Non-GAAP
net loss per share, basic and diluted |
$ |
(0.87 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.69 |
) |
|
$ |
(0.90 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used to compute net loss per share,
|
|
|
|
|
|
|
|
|
basic and diluted |
|
30,128,150 |
|
|
|
24,139,791 |
|
|
|
29,728,477 |
|
|
|
23,670,508 |
|
|
|
|
|
|
|
|
|
|
Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior 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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