– Positive top-line PROMISE 1 study
results further support eptinezumab’s unique clinical profile
–
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage
biopharmaceutical company developing monoclonal antibody
therapeutics, today announced financial results for the second
quarter ended June 30, 2017, and provided a corporate update.
“Migraine is a debilitating disease in which current
preventative treatment options fail to meet the needs of severe
migraine patients. There is a significant market need for new
effective treatment options that we believe can be served by
eptinezumab, our investigational migraine prevention candidate and
one of a new class of anti-CGRP migraine treatments in
development,” said Randall C. Schatzman, Ph.D., president and chief
executive officer of Alder. “We were pleased to report
positive top-line results from PROMISE 1, our first pivotal trial
for eptinezumab, during the second quarter, which builds upon the
robust clinical data we have observed to date. We believe
that eptinezumab’s highly competitive and differentiated profile,
coupled with the fact that it is the only anti-CGRP migraine
treatment administered by infusion in development, will provide a
distinct commercial advantage for Alder in the emerging
CGRP-directed treatment market. We believe that this would
translate to a U.S. market opportunity for eptinezumab infusion
therapy, if approved, in the range of approximately $1.5 to $2.0
billion. With our balance sheet enhanced by our recently completed
public offering and our disciplined spending plan, we are
well-positioned to continue advancing eptinezumab and our goal of
transforming the treatment of migraine.”
Recent Corporate Highlights
Eptinezumab – Pivotal-stage novel monoclonal antibody targeting
the calcitonin gene-related peptide (CGRP) for the prevention of
migraine
- Reported top-line three and six month results from the PROMISE
1 (PRevention Of
Migraine via Intravenous
eptinezumab Safety and Efficacy
1) Phase 3 pivotal clinical trial on June 27,
2017. PROMISE 1 is evaluating the safety and efficacy of
eptinezumab administered via infusion once every 3 months in 888
patients with frequent episodic migraine in the United States. The
results demonstrated: • Eptinezumab met the
primary endpoint: highly statistically significant
reductions in monthly migraine days from baseline through three
months; • Rapid speed to clinical
benefit: a statistically significant >50% reduction in
the proportion of patients experiencing a migraine on Day 1 post
dose; • Statistically significant efficacy
responses observed at all key time points: ~ 1/3 of
patients attained a >75% reduction in migraine days through 1
month and sustained through 3 months (300mg dose); •
Migraine free relief: average 1 in 5
patients had 100% response (i.e., no migraines) in any given month
(reduction from a baseline of >8 mean migraine days/month);
and • Safety profile similar to
placebo: consistent with previously reported eptinezumab
studies.
- Completed public offering of common stock on July 18, 2017
resulting in net proceeds to Alder of approximately $161.5 million,
after underwriting discounts, commissions and estimated offering
expenses.
- Presented additional data in June 2017 at the 59th Annual
Scientific Meeting of the American Headache Society from Alder’s
eptinezumab program, including additional positive data from the
Phase 2b trial of eptinezumab for the prevention of chronic
migraine and information describing the rational design objectives
and selection of attributes that are important for supporting the
desired clinical profile of a migraine prevention
therapy.
- In June 2017, submitted Alder’s statement setting out the
grounds of appeal with respect to the decision of the European
Patent Office Opposition Division to maintain certain patent claims
granted to Teva.
Upcoming Eptinezumab Milestones Expected in
2H-2017
- Presentation of additional data from Alder’s eptinezumab
program at the 18th Congress of the International Headache Society,
to be held September 7-10, 2017.
- Completion of enrollment in PROMISE 2
(PRevention Of
Migraine via Intravenous
eptinezumab Safety and Efficacy
2) study in the second half of 2017. PROMISE 2 is
the company's ongoing pivotal study that is evaluating the safety
and efficacy of eptinezumab administered via infusion once every 3
months in approximately 1,050 patients with chronic migraine.
Second Quarter 2017 Financial Results
Research and development expenses for the
quarter ended June 30, 2017 totaled $65.3 million, compared to
$33.8 million for the same period in 2016. The increase in expenses
was primarily due to the eptinezumab program, with increased
external manufacturing costs for commercial readiness activities
and drug supply in support of planned and ongoing clinical trials
and increased external clinical trial costs. Alder also experienced
increased salaries expense and stock-based compensation expense
because of headcount growth in research and development to support
ongoing and planned clinical trials and other development
activities.
General and administrative expenses for the
quarter ended June 30, 2017 totaled $9.5 million, compared to $6.5
million for the same period in 2016. The increases in spending were
primarily due to an increase in stock-based compensation expense
and salaries expense due to an increase in headcount, as well as
increases in professional fees and other administrative costs to
support commercial readiness activities.
Net loss for the quarter ended June 30, 2017
totaled $74.6 million, or $1.48 per share, compared to net loss of
$38.9 million, or $0.79 per share on a fully-diluted basis, for the
same period in 2016.
Cash and cash equivalents and short-term
investments totaled $224.5 million as of June 30, 2017, compared to
$289.6 million as of March 31, 2017.
Financial Outlook
Alder estimates its available cash and cash equivalents and
short-term investments totaling $224.5 million as of June 30, 2017,
together with the net proceeds of approximately $161.5 million
received from its July 2017 public offering, will be sufficient to
meet the company’s projected operating requirements through late
2018/early 2019 and enable it to achieve the following key
activities:
- Read-out of top-line data from PROMISE 2;
- Completion of the eptinezumab infusion pivotal trial
program;
- Planned submission of a Biologics License Application for the
eptinezumab infusion formulation;
- Establishment of a commercial drug supply chain for the
eptinezumab infusion formulation; and
- Advancement of the eptinezumab subcutaneous mode of
administration.
Conference Call and Webcast
Alder will host a conference call today at 5:00 p.m. EDT to
discuss these financial results and recent corporate highlights.
The live call may be accessed by dialing (877) 430-4657 for
domestic callers or (484) 756-4339 for international callers, and
providing conference ID number 51609769. The webcast and any
accompanying slides can be accessed from the Events &
Presentations page in the Investors section of Alder's website at
www.alderbio.com and will be available for replay following the
call for 30 days.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc., is a clinical-stage
biopharmaceutical company that discovers, develops and seeks to
commercialize genetically engineered therapeutic antibodies with
the potential to meaningfully transform current treatment
paradigms. Alder's lead pivotal-stage product candidate,
eptinezumab, is being evaluated for migraine prevention.
Eptinezumab is a monoclonal antibody that inhibits calcitonin
gene-related peptide (CGRP), a protein that is active in mediating
the initiation of migraine. Alder is additionally evaluating
ALD1910, a preclinical product candidate also in development as a
migraine prevention therapy. ALD1910 is a monoclonal antibody that
inhibits pituitary adenylate cyclase-activating polypeptide-38
(PACAP-38), another protein that is active in mediating the
initiation of migraine. Clazakizumab, Alder's third program, is a
monoclonal antibody candidate that inhibits interleukin-6 and is
licensed to Vitaeris, Inc. For more information, please visit
http://www.alderbio.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements relating to: the
continued development and clinical, therapeutic and commercial
potential of eptinezumab; the significant market need for new
effective preventative migraine treatment options; the availability
of results from clinical trials; future regulatory filings and the
potential regulatory approval of eptinezumab; eptinezumab’s
competitive and differentiated profile and anticipated commercial
advantage; the U.S. market opportunity for eptinezumab; Alder’s
goal of transforming the treatment of migraine; future data
presentations; and Alder’s financial outlook, including the
sufficiency of Alder’s cash resources to meet projected operating
requirements and enable the achievement of key activities. Words
such as “support,” “expected,” “enable,” “continue,” “advancement,”
“planned,” “achieve,” “need,” “options,” “believe,” “can,”
“builds,” “will,” “advantage,” “emerging,” “would,” “opportunity,”
“well-positioned,” “goal,” “presentation,” “completion,” “outlook,”
“estimates,” “sufficient,” or other similar expressions, identify
forward-looking statements, but the absence of these words does not
necessarily mean that a statement is not forward-looking. In
addition, any statements that refer to expectations, projections or
other characterizations of future events or circumstances are
forward-looking statements. The forward-looking statements in this
press release are based upon Alder's current plans, assumptions,
beliefs, expectations, estimates and projections, and involve
substantial risks and uncertainties. Actual results and the timing
of events could differ materially from those anticipated in the
forward-looking statements due to these risks and uncertainties as
well as other factors, which include, without limitation: risks
related to the potential failure of eptinezumab to demonstrate
safety and efficacy in clinical testing; Alder's ability to conduct
clinical trials and studies of eptinezumab sufficient to achieve a
positive completion; the availability of data at the expected
times; the clinical, therapeutic and commercial value of
eptinezumab; risks and uncertainties related to regulatory
application, review and approval processes and Alder's compliance
with applicable legal and regulatory requirements; risks and
uncertainties relating to the manufacture of eptinezumab; Alder's
ability to obtain and protect intellectual property rights, and
operate without infringing on the intellectual property rights of
others; the uncertain timing and level of expenses associated with
Alder's development and commercialization activities; the
sufficiency of Alder's capital and other resources; market
competition; changes in economic and business conditions; and other
factors discussed under the caption "Risk Factors" in Alder's
Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2017, which was filed with the Securities and Exchange
Commission (SEC) on August 8, 2017, and is available on the SEC's
website at www.sec.gov. Additional information will also be set
forth in Alder's other reports and filings it will make with the
SEC from time to time. The forward-looking statements made in this
press release speak only as of the date of this press release.
Alder expressly disclaims any duty, obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Alder's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets |
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
224,481 |
|
|
$ |
351,867 |
Prepaid expenses and
other assets |
|
|
29,487 |
|
|
|
57,287 |
Total assets |
|
$ |
253,968 |
|
|
$ |
409,154 |
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
34,547 |
|
|
$ |
26,371 |
Total stockholders’
equity |
|
|
219,421 |
|
|
|
382,783 |
Total liabilities and
stockholders’ equity |
|
$ |
253,968 |
|
|
$ |
409,154 |
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of
Operations |
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
(Amounts in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2017 |
|
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and
license agreements |
$ |
683 |
|
|
|
$ |
113 |
|
|
|
$ |
683 |
|
|
|
$ |
113 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
683 |
|
|
|
|
113 |
|
|
|
|
683 |
|
|
|
|
113 |
|
Research
and development |
|
65,276 |
|
|
|
|
33,833 |
|
|
|
|
155,965 |
|
|
|
|
61,480 |
|
General
and administrative |
|
9,548 |
|
|
|
|
6,466 |
|
|
|
|
19,529 |
|
|
|
|
12,511 |
|
Total operating
expenses |
|
75,507 |
|
|
|
|
40,412 |
|
|
|
|
176,177 |
|
|
|
|
74,104 |
|
Gain on
license of clazakizumab |
|
0 |
|
|
|
|
1,050 |
|
|
|
|
0 |
|
|
|
|
1,050 |
|
Loss from
operations |
|
(74,824 |
) |
|
|
|
(39,249 |
) |
|
|
|
(175,494 |
) |
|
|
|
(72,941 |
) |
Other income, net |
|
195 |
|
|
|
|
383 |
|
|
|
|
537 |
|
|
|
|
712 |
|
Net loss |
$ |
(74,629 |
) |
|
|
$ |
(38,866 |
) |
|
|
$ |
(174,957 |
) |
|
|
$ |
(72,229 |
) |
Net loss per share -
basic and diluted |
$ |
(1.48 |
) |
|
|
$ |
(0.79 |
) |
|
|
$ |
(3.47 |
) |
|
|
$ |
(1.55 |
) |
Weighted average number
of common shares used in net loss per share - basic and
diluted |
|
50,427,865 |
|
|
|
|
49,284,573 |
|
|
|
|
50,411,837 |
|
|
|
|
46,519,045 |
|
Media Contacts:
David Schull
Russo Partners, LLC
(212) 845-4271
david.schull@russopartnersllc.com
Investor Relations Contact:
David Walsey
Alder BioPharmaceuticals
(425) 408-8032
ir@alderbio.com
Alder BioPharmaceuticals (NASDAQ:ALDR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Alder BioPharmaceuticals (NASDAQ:ALDR)
Historical Stock Chart
From Apr 2023 to Apr 2024