Portola Pharmaceuticals Reports Fourth Quarter and Year-End 2015 Financial Results and Provides Corporate Update
10 Mars 2016 - 1:46AM
Portola Pharmaceuticals (Nasdaq:PTLA) today provided a corporate
update and reported its financial results for the fourth quarter
and year ended December 31, 2015.
“During the fourth quarter of 2015, we executed on several
milestones that we expect will make 2016 a year of unprecedented
progress. We plan to commercially launch andexanet alfa and report
pivotal Phase 3 results from our APEX study that, if positive, will
support the global approval of betrixaban,” said Bill Lis, chief
executive officer of Portola. “Both have the potential to benefit
the patients and transform the field in the multibillion dollar
thrombosis market. Additionally, our R&D pipeline
continues to progress with our ongoing Phase 1/2 study with
cerdulatinib, our oral, dual syk/JAK inhibitor in
refractory/relapsed hematologic cancer patients.”
Recent Achievements, Upcoming Events and
Milestones
Betrixaban – an FDA-designated Fast Track oral Factor Xa
inhibitor anticoagulant in development for the prevention of venous
thromboembolism (VTE) in acute medically ill patients.
- Plan to report topline results from the 7,514-patient pivotal
Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended
Duration Betrixaban) Study in early April.
- Plan to submit a New Drug Application to the FDA in the second
half of 2016, subject to positive APEX data.
Andexanet alfa – an FDA-designated Breakthrough Therapy Factor
Xa inhibitor antidote in development for reversal of
anticoagulation in patients treated with a Factor Xa inhibitor and
who are admitted to the hospital with uncontrolled bleeding or need
urgent surgery.
- The FDA accepted the Biologics License Application (BLA) for
filing February 16, 2016. The BLA was granted a priority review
under an Accelerated Approval pathway, and assigned a PDUFA date of
August 17, 2016. We plan to launch andexanet alfa commercially in
the U.S. in the second half of 2016, subject to FDA approval.
- The full data set from the ANNEXA-R study with rivaroxaban was
presented in a Late-Breaking Clinical Trial Session at the American
Heart Association’s Scientific Sessions 2015 and simultaneously
published in the New England Journal of Medicine.
- Licensed development and commercial rights in Japan to
Bristol-Myers Squibb Company and Pfizer Inc. Separately, entered
into a clinical collaboration agreement with Bayer HealthCare to
include its Factor Xa inhibitor rivaroxaban in the development
program in Japan.
- Continue to enroll patients in ANNEXA-4, a Phase 4 confirmatory
study of patients receiving apixaban, rivaroxaban, edoxaban or
enoxaparin who present to the hospital with an acute major
bleed.
- Plan to present data from the Phase 2 proof-of-concept
andexanet study with betrixaban in healthy volunteers at a medical
conference in 2016 The study was designed to evaluate safety and
define the dose of andexanet required to reverse the anticoagulant
effect of betrixaban.
- Plan to complete FDA pre-approval inspection of the initial
launch supply (Generation 1 2,500 liter scale at CMC
Biologics). Generation 1 validation batch runs at the 6 x
2,000 liter scale are ongoing.
- Completed two Generation 2 engineering batches manufactured by
Lonza at the 10,000 liter scale, with target yields achieved.
Expect commercial validation batches to begin in the second half of
2016.
Cerdulatinib – an oral, dual Syk/JAK kinase inhibitor in
development to treat resistant or relapsed hematologic cancer
patients.
- Presented three abstracts at the 2015 ASH Annual Meeting on
cerdulatinib’s preclinical activity in chronic lymphocytic
leukemia; clinical and pharmacodynamic results of a Phase 1/2 study
with relapsed/refractory B cell malignancies; and pharmacokinetic
modeling of cerdulatinib plasma concentrations in patients with
relapsed/refractory B cell malignancies.
- Continue to dose-escalate for clinical activity and
tolerability in the ongoing Phase 1/2 study in patients with
relapsed/refractory B-cell malignancies. Plan to initiate
enrollment in expansion cohorts this year.
Corporate
- Raised $162.7 million in net proceeds from an underwritten
public offering of common stock in December 2015.
Fourth Quarter and Year-End Financial
ResultsCollaboration revenue earned under Portola's
collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer
Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Lee's
Pharmaceutical was $4.4 million for the fourth quarter of 2015
compared with $2.4 million for the fourth quarter of 2014.
Collaboration revenue for the year ended December 31, 2015, was
$12.1 million compared with $9.6 million for the year ended
December 31, 2014.
Total operating expenses for the fourth quarter of 2015 were
$70.7 million compared with $41.7 million for the same period in
2014. Total operating expenses for the fourth quarter of 2015
included $6.8 million in stock-based compensation expense compared
with $2.5 million for the same period in 2014. Total operating
expenses for the year ended December 31, 2015, were $239.2 million
compared with $147.2 million for 2014. Total operating expenses for
the full year ended December 31, 2015, included $22.9 million in
stock-based compensation expense compared with $9.3 million for
2014. Research and development expenses were $200.4 million for the
year ended December 31, 2015, compared with $123.6 million for
2014, as the Company continued to support its manufacturing
scale-up of andexanet alfa in preparation for the BLA submission
and commercial launch and work on its larger-scale Generation 2
manufacturing process at Lonza, its Phase 3 and Phase 4 ANNEXA
studies of andexanet alfa, completing enrollment in the Phase 3
APEX Study of betrixaban, and its Phase 1/2a clinical study of
cerdulatinib. Selling, general and administrative expenses for the
fourth quarter of 2015 were $10.9 million compared with $7.0
million for the same period in 2014. Selling, general and
administrative expenses for the year ended December 31, 2015, were
$38.9 million compared with $23.6 million for 2014, as the Company
increased headcount to support its growth and increased
pre-commercial launch activities, including hiring key regional
sales directors and national account managers and further
developing medical affairs.
For the fourth quarter of 2015, Portola reported a net loss of
$66.1 million, or $1.23 net loss per share, compared with a net
loss of $39.3 million, or $0.82 net loss per share, for the same
period in 2014. Net loss for the year ended December 31, 2015, was
$226.5 million, or $4.36 net loss per share, compared with a net
loss of $137.1 million, or $3.19 net loss per share, for the same
period in 2014.
Cash, cash equivalents and investments at December 31, 2015,
totaled $460.2 million compared with cash, cash equivalents and
investments of $392.3 million as of December 31, 2014.
Conference Call DetailsTo access the live
conference call today, February 26, 2016, at 8:30 am Eastern Time
via phone, please dial (844) 452-6828 from the United States and
Canada or +1 (765) 507-2588 internationally, and use the passcode
48937755. Please dial in 10 minutes prior to the start of the call.
To access the live and subsequently archived webcast of the
conference call, go to the Investor Relations section of the
Company's website at http://investors.portola.com. Please connect
to the website at least 15 minutes prior to the call to allow for
any software download that may be necessary. A replay of the
webcast will be available on the Company's website for 30 days
following the live event.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company
developing product candidates that could significantly advance the
fields of thrombosis and other hematologic diseases. The Company is
advancing its three wholly-owned programs using novel biomarker and
genetic approaches that may increase the likelihood of clinical,
regulatory and commercial success. These programs include
betrixaban, an oral, once-daily Factor Xa inhibitor being evaluated
in the APEX Phase 3 study for prophylaxis of venous
thromboembolism; andexanet alfa, a recombinant protein designed to
reverse the anticoagulant effect in patients treated with an oral
or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK
inhibitor in development to treat hematologic cancers. Portola's
partnered program is focused on developing selective Syk inhibitors
for inflammatory conditions. For more information, visit
www.portola.com and follow the Company on Twitter
@Portola_Pharma.
Portola Forward-looking Statement Statements
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.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such statements
include, but are not limited to, statements regarding: the timing
and ability to achieve the milestones and events described under
the section "Recent Achievements, Upcoming Events and Milestones,"
our goal of becoming a fully commercialized biopharmaceutical
company, the projected timing of our product launches, the
occurrence and timing of planned filings with the FDA and the
timing of our reporting of clinical data. Risks that contribute to
the uncertain nature of the forward-looking statements include:
failure to obtain FDA approval for one or more of our product
candidates, our expectation that we will incur losses for the
foreseeable future and will need additional funds to finance our
operations; the accuracy of our estimates regarding our ability to
initiate and/or complete our clinical trials and the timing and
expense of these trials; the pace of enrollment in our clinical
trials; the results of our clinical trials related to the efficacy
and safety of our product candidates; our potential inability to
manufacture our product candidates on a commercial scale in a
timely or cost-efficient manner; the accuracy of our estimates
regarding expenses and capital requirements; our ability to
successfully build a hospital-based sales force and commercial
infrastructure; regulatory developments in the United States and
foreign countries; our ability to obtain and maintain intellectual
property protection for our product candidates; and our ability to
retain key scientific or management personnel. These and other
risks and uncertainties are described more fully in our most recent
filings with the Securities and Exchange Commission, including our
Annual Report on Form 10-K, which we expect to file on February 29,
2016. All forward-looking statements contained in this press
release speak only as of the date on which they were made. We
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date on which they
were made.
Unaudited Condensed Statements of
Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended |
|
|
Twelve
Months Ended |
December 31, |
December 31, |
|
2015 |
|
|
2014 |
|
|
2015 |
|
|
2014 |
Collaboration and license
revenue |
$ |
|
4,414 |
|
|
|
$ |
|
2,412 |
|
|
|
$ |
|
12,070 |
|
|
|
$ |
|
9,625 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
59,814 |
|
|
|
|
|
34,722 |
|
|
|
|
|
200,376 |
|
|
|
|
|
123,639 |
|
Selling, general and
administrative |
|
|
10,881 |
|
|
|
|
|
6,950 |
|
|
|
|
|
38,869 |
|
|
|
|
|
23,552 |
|
Total operating expenses |
|
|
70,695 |
|
|
|
|
|
41,672 |
|
|
|
|
|
239,245 |
|
|
|
|
|
147,191 |
|
Loss from operations |
|
|
(66,281 |
) |
|
|
|
|
(39,260 |
) |
|
|
|
|
(227,175 |
) |
|
|
|
|
(137,566 |
) |
Interest and other income
(expense),net |
|
|
(190 |
) |
|
|
|
|
5 |
|
|
|
|
|
305 |
|
|
|
|
|
441 |
|
Net loss attributable to common
stockholders |
$ |
|
(66,471 |
) |
|
|
$ |
|
(39,255 |
) |
|
|
$ |
|
(226,870 |
) |
|
|
$ |
|
(137,125 |
) |
Income tax benefit |
|
|
365 |
|
|
|
|
|
- |
|
|
|
|
|
365 |
|
|
|
|
|
- |
|
Net loss |
$ |
|
(66,106 |
) |
|
|
$ |
|
(39,255 |
) |
|
|
$ |
|
(226,505 |
) |
|
|
$ |
|
(137,125 |
) |
Net loss attributable to
Noncontrolling interest (VIE) |
|
|
- |
|
|
|
|
|
- |
|
|
|
|
|
- |
|
|
|
|
|
- |
|
Net loss attributable to
Portola |
$ |
|
(66,106 |
) |
|
|
$ |
|
(39,255 |
) |
|
|
$ |
|
(226,505 |
) |
|
|
$ |
|
(137,125 |
) |
Shares used to compute net loss
per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
53,623,313 |
|
|
|
|
|
48,153,468 |
|
|
|
|
|
51,981,463 |
|
|
|
|
|
42,997,463 |
|
Net loss per share attributable
to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
|
(1.23 |
) |
|
|
$ |
|
(0.82 |
) |
|
|
$ |
|
(4.36 |
) |
|
|
$ |
|
(3.19 |
) |
Unaudited Condensed Balance Sheet
Data |
|
|
|
|
|
|
(In thousands) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2015 |
2014 |
|
(Unaudited) |
|
Cash, cash equivalents and investments |
$ |
460,161 |
|
$ |
392,303 |
|
Prepaid research and development |
|
16,976 |
|
|
1,686 |
|
Total current assets |
|
465,577 |
|
|
315,077 |
|
Property and equipment, net |
|
6,243 |
|
|
2,776 |
|
Intangible assets |
|
3,151 |
|
|
- |
|
Total assets |
|
502,924 |
|
|
416,495 |
|
Accounts payable |
|
10,279 |
|
|
14,084 |
|
Accrued research and development |
|
24,195 |
|
|
12,545 |
|
Accrued compensation and other liabilities |
|
8,285 |
|
|
4,933 |
|
Deferred revenue (current portion and
long-term) |
|
27,016 |
|
|
36,585 |
|
Total current liabilities |
|
51,146 |
|
|
41,131 |
|
Total liabilities |
|
72,601 |
|
|
68,693 |
|
Total Portola stockholders’ equity |
|
427,396 |
|
|
347,802 |
|
Noncontrolling interest (VIE) |
|
2,927 |
|
|
- |
|
Total liabilities and stockholders equity |
|
502,924 |
|
|
416,495 |
|
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
Portola Pharmaceuticals (NASDAQ:PTLA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Portola Pharmaceuticals (NASDAQ:PTLA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024