Adverum Biotechnologies, Inc. Reports Third Quarter 2016 Financial Results
November 08 2016 - 4:05PM
Adverum Biotechnologies, Inc. (Nasdaq:ADVM), a gene therapy company
committed to discovering and developing novel medicines for
patients suffering from diseases with few or burdensome treatment
options, today reported financial results for the third quarter
ended September 30, 2016.
“Our new leadership team is focused on executing our plans to
advance our three lead gene therapy programs into the clinic to
address alpha 1 antitrypsin deficiency, wet AMD and hereditary
angioedema,” said Amber Salzman, Ph.D., president and chief
executive officer of Adverum Biotechnologies. “At recent scientific
conferences, we have presented promising preclinical efficacy data
on our two new anti-VEGF candidates for wet AMD, ADVM-022 and
ADVM-032. These intravitreally administered therapies have the
potential to minimize the treatment burden of frequent injections
and maximize visual outcomes in patients living with this disease.
For ADVM-043, our gene therapy for alpha 1 antitrypsin deficiency,
we are upgrading to a robust, commercial-ready manufacturing
process. We expect to initiate patient enrollment in a Phase 1/2
clinical trial in the fourth quarter of 2017. We have a strong AAV
vector platform, AAV manufacturing technology expertise, an
advancing pipeline of novel gene therapies, and a solid cash
position, which we believe will enable us to develop important new
treatment options for patients.”
Financial Results for the Three Months Ended September
30, 2016
- Cash, cash equivalents and marketable
securities were $231.3 million as of September 30,
2016, compared to $241.3 million as of June 30, 2016 and
$259.1 million as of December 31, 2015.
- Revenues, consisting of revenue from
collaborative research, were $0.4 million for the three months
ended September 30, 2016, compared to $1.0 million for
the same period in 2015. Revenues for the three months ended
September 30, 2015 included the recognition of a one-time milestone
under a collaboration agreement.
- Research and development expenses
were $8.4 million for the three months
ended September 30, 2016, compared to $7.5 million for the
same period in 2015. This increase was primarily attributable to
material production, preclinical study, and toxicology study
expenses for the Company’s wet AMD, A1AT deficiency and HAE
programs, partially offset by a decrease in stock-based
compensation expense.
- General and administrative expenses
were $6.1 million for the three months
ended September 30, 2016, compared to $7.6
million for the same period in 2015. This reduction was
primarily due to a decrease in stock-based compensation expense,
partially offset by an increase in severance-related and
professional services expenses.
- Goodwill impairment charge was $0.4 million
for the three months ended September 30, 2016 and relates to an
additional non-cash goodwill impairment charge recorded in
connection with the Annapurna transaction that closed in May 2016.
This non-cash charge is the result of the Company’s goodwill
assessment that is based on its market capitalization relative to
the carrying value of its net assets.
- Net loss attributable to common stockholders
was $14.3 million or $0.35 per basic and diluted
share, for the three months ended September 30, 2016,
compared to $14.1 million, or $0.55 per basic and diluted
share, for the same period in 2015.
About Adverum Biotechnologies,
Inc.Adverum is a gene therapy company committed to
discovering and developing novel medicines that can offer
life-changing benefits to patients living with rare diseases or
diseases of the eye who currently have limited or burdensome
treatment options. Adverum has a robust pipeline that includes
product candidates to treat wet AMD, A1AT deficiency, and
hereditary angioedema. Leveraging a next-generation
adeno-associated virus (AAV)-based directed evolution platform, the
Company generates product candidates designed to provide durable
efficacy by inducing sustained expression of a therapeutic protein.
Adverum has collaboration agreements with Regeneron Pharmaceuticals
to research, develop, and commercialize gene therapy products for
ophthalmic diseases and Editas Medicine to explore the delivery of
genome editing medicines for the treatment of inherited retinal
diseases. Adverum has clinical development expertise and core
capabilities in vector optimization, process development,
manufacturing, and assay development. For more information please
visit www.adverum.com.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements
include, but are not limited to, statements regarding Adverum’s
plans, potential opportunities, expectations, projections, goals,
objectives, milestones, strategies, product pipeline, financial
condition and results of operations, the sufficiency of its cash,
cash equivalents and marketable securities, as well as the
advancement of, and anticipated development and regulatory
milestones and plans related to, Adverum’s product candidates and
preclinical and clinical studies, and the commercial potential of
its product candidates, all of which are based on certain
assumptions made by Adverum on current conditions, expected future
developments and other factors Adverum believes are appropriate in
the circumstances. Adverum may not consummate any plans or product
or clinical development goals in a timely manner, or at all, or
otherwise carry out the intentions or meet the expectations or
projections disclosed in its forward-looking statements, and you
should not place undue reliance on these forward-looking
statements. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, the risk that Adverum’s resources will
not be sufficient for Adverum to conduct or continue planned
development programs and planned clinical trials, the risk of a
delay in the enrollment of patients in Adverum’s clinical studies
or in the manufacturing of products to be used in such clinical
studies, and the risk that Adverum will not be able to successfully
develop or commercialize any of its product candidates. Risks and
uncertainties facing Adverum are described more fully in Adverum’s
periodic reports filed with the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Adverum undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
|
|
ADVERUM BIOTECHNOLOGIES, INC. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
ASSETS |
|
|
(unaudited) |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
$ |
231,271 |
|
|
$ |
259,080 |
|
Prepaid
expenses and other current assets |
|
|
4,625 |
|
|
|
1,912 |
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
|
235,896 |
|
|
|
260,992 |
|
Property
and equipment, net |
|
|
4,335 |
|
|
|
3,187 |
|
Intangible assets |
|
|
16,200 |
|
|
|
- |
|
Deposits
and other long-term assets |
|
|
140 |
|
|
|
140 |
|
|
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
256,571 |
|
|
$ |
264,319 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
8,844 |
|
|
$ |
4,612 |
|
Restructuring liability |
|
|
25 |
|
|
|
1,013 |
|
Current
portion of deferred rent |
|
|
89 |
|
|
|
66 |
|
Current
portion of deferred revenue |
|
|
1,691 |
|
|
|
883 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
|
10,649 |
|
|
|
6,574 |
|
|
|
|
|
|
|
|
|
|
Deferred
rent, less current portion |
|
|
378 |
|
|
|
447 |
|
Deferred
revenue, less current portion |
|
|
6,834 |
|
|
|
4,706 |
|
Deferred
tax liability |
|
|
2,025 |
|
|
|
- |
|
Other
liabilities |
|
|
455 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
|
20,341 |
|
|
|
11,727 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
236,230 |
|
|
|
252,592 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
256,571 |
|
|
$ |
264,319 |
|
|
|
|
|
|
|
|
ADVERUM BIOTECHNOLOGIES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September
30, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
|
395 |
|
|
$ |
|
953 |
|
|
$ |
|
967 |
|
|
$ |
|
1,359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,362 |
|
|
|
|
7,523 |
|
|
|
|
23,772 |
|
|
|
|
18,270 |
|
General and administrative |
|
|
6,146 |
|
|
|
|
7,631 |
|
|
|
|
19,578 |
|
|
|
|
16,733 |
|
Goodwill impairment charge |
|
|
394 |
|
|
|
|
- |
|
|
|
|
49,514 |
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
14,902 |
|
|
|
|
15,154 |
|
|
|
|
92,864 |
|
|
|
|
35,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(14,507 |
) |
|
|
|
(14,201 |
) |
|
|
|
(91,897 |
) |
|
|
|
(33,644 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
206 |
|
|
|
|
117 |
|
|
|
|
544 |
|
|
|
|
285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to |
|
|
|
|
|
|
|
|
|
|
|
common stockholders |
$ |
|
(14,301 |
) |
|
$ |
|
(14,084 |
) |
|
$ |
|
(91,353 |
) |
|
$ |
|
(33,359 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common |
|
|
|
|
|
|
|
|
|
|
|
stockholders, basic and diluted |
$ |
|
(0.35 |
) |
|
$ |
|
(0.55 |
) |
|
$ |
|
(2.66 |
) |
|
$ |
|
(1.31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares |
|
|
|
|
|
|
|
|
|
|
|
outstanding, basic and diluted |
|
|
41,416 |
|
|
|
|
25,685 |
|
|
|
|
34,382 |
|
|
|
|
25,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts for Adverum:
Leone Patterson
Chief Financial Officer
Adverum Biotechnologies, Inc.
650-665-7222
lpatterson@adverum.com
Jill Steier
Senior Vice President
The Trout Group LLC
646-378-2946
jsteier@troutgroup.com
Adverum Biotechnologies (NASDAQ:ADVM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adverum Biotechnologies (NASDAQ:ADVM)
Historical Stock Chart
From Sep 2023 to Sep 2024