Portola Pharmaceuticals Reports Third Quarter Financial Results and Provides Corporate Update
05 Novembre 2013 - 10:00PM
Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today will provide a
corporate update and report its financial results for the third
quarter ended September 30, 2013.
"Throughout this year, we demonstrated our continued ability to
execute on our strategic plan and reconfirm our long-term
commitment to building an enduring growth company," said William
Lis, chief executive officer of Portola. "We believe we have an
exciting portfolio of wholly-owned product candidates. Our lead
agent, betrixaban, is being developed as an anticoagulant for the
prevention of fatal blood clots in acute medically ill patients.
Andexanet alfa has the potential to be a first-in-class reversal
agent for anticoagulated patients experiencing a fatal bleed or
requiring emergency surgery. And PRT2070 is a unique oral dual
kinase inhibitor being evaluated in patients with hematologic
cancers, including those with genetically-defined and
difficult-to-treat subtypes. With the proceeds from our recently
completed follow-on equity offering, we are well positioned to
advance these assets to value-creating milestones planned for 2014
and 2015, including Phase 3 APEX data for betrixaban, Biologics
License Application filing for andexanet alfa, and proof-of-concept
data for PRT2070."
Recent Events Corporate
- Completed a follow-on equity financing on October 22, 2013,
raising approximately $100 million in net proceeds for the Company.
With the follow-on offering, the Company now plans to advance
andexanet alfa to a BLA filing and expand the scope of the PRT2070
Phase 2 proof-of-concept study to include additional cancer
types.
- Appointed Mark Gossett as senior vice president of commercial
to build, lead and develop the commercial organization. He has more
than 25 years of experience commercializing important medicines,
including the multi-billion dollar anticoagulant Lovenox®
(enoxaparin).
Betrixaban
- Continued to enroll patients in the global Phase 3 APEX study
(Acute Medically Ill VTE Prevention with Extended Duration
Betrixaban), which is evaluating betrixaban for hospital and
post-discharge prevention of venous thromboembolism in high-risk,
acute medically ill patients. The independent data monitoring
committee for this study held its second meeting in August and
recommended that the Company proceed with the study as
planned.
Andexanet alfa (PRT4445*)
- Announced new findings from a Phase 2 proof-of-concept study of
andexanet alfa administered as a bolus plus continuous infusion for
up to two hours. Results showed a rapid and near complete reversal
of the anticoagulation effect of the Factor Xa inhibitor Eliquis®,
which was sustained for the duration of the infusion.
- Presented data at the 2013 European Society of Cardiology
Congress demonstrating that andexanet alfa reduced blood loss in
anticoagulated animals experiencing an active bleed by reversing
Factor Xa inhibitor activity.
- Completed an end-of-phase 2 meeting with the Food and Drug
Administration regarding the clinical and manufacturing paths
forward for andexanet, and based on those discussions, the Company
plans to pursue an Accelerated Approval pathway.
- Entered into a collaboration agreement with Daiichi Sankyo for
a Phase 2 program to evaluate andexanet alfa in reversing the
anticoagulant activity of the investigational Factor Xa inhibitor
edoxaban.
PRT2070
- Initiated and began enrollment in a Phase 1/2 proof-of-concept
clinical study of the oral dual Syk-JAK inhibitor PRT2070 in
patients with non-Hodgkin's lymphoma or chronic lymphocytic
leukemia, including those patients who have progressive or relapsed
disease, genetically-defined subtypes or acquired mutations.
Planned Upcoming Milestones Betrixaban
- Complete a futility analysis in 2014 of the Phase 3 APEX Study.
Portola remains on track to complete APEX enrollment and report
data in mid-2015.
Andexanet alfa
- Report data from two Phase 2 studies of andexanet alfa and the
Factor Xa inhibitors XARELTO® (rivaroxaban) and Lovenox®
(enoxaparin) over the next two quarters.
- Initiate a pivotal Phase 3 study and Phase 4 confirmatory study
in 2014, while concurrently working on manufacturing transfer and
process development changes at Lonza Group.
PRT2070
- Report proof-of-activity data from the Phase 1/2 clinical study
in 2014.
Third Quarter Financial Results
Collaboration revenue for the third quarter of 2013 was $2.8
million earned under the Company's collaborations with
Bristol-Myers Squibb Company and Pfizer Inc., Bayer Pharma AG and
Janssen Pharmaceuticals, Inc., Daiichi Sankyo, Inc. and Lee's
Pharmaceutical (HK), Ltd. Collaboration revenue for the third
quarter of 2012 was $0.7 million earned under the Company's
collaboration with Novartis AG, which was terminated effective July
1, 2012.
Total operating expenses for the third quarter of 2013 were
$22.0 million compared with $12.8 million for the third quarter of
2012. The increase in operating expenses was primarily attributable
to increased investment in research and development expenses to
advance clinical development of betrixaban, andexanet alfa and
PRT2070.
Net loss for the third quarter of 2013 was $18.6 million, or
$0.53 per share, compared with a net loss of $11.5 million, or
$8.38 per share, for the third quarter of 2012.
As of September 30, 2013, cash, cash equivalents and investments
were $218.9 million compared with cash, cash equivalents and
investments of $137.4 million as of December 31, 2012. In October
2013, the company raised approximately $100 million in net proceeds
through a follow-on offering of common stock that is not reflected
in the third quarter cash balance.
Conference Call Details
To access the live conference call today, November 5, 2013, at
4:30 p.m. Eastern Time via phone, please dial (866) 515-2912 from
the United States and Canada or +1 (617) 399-5126 internationally.
The participant passcode is 80397477. 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.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company focused
on the development and commercialization of novel therapeutics in
the areas of thrombosis, other hematologic disorders and
inflammation. Portola's wholly-owned lead compound, betrixaban, is
a novel, oral, once-daily Factor Xa inhibitor in Phase 3
development for extended-duration prophylaxis of a form of
thrombosis known as venous thromboembolism (VTE) in acute medically
ill patients. Currently, there is no anticoagulant approved for
extended-duration VTE prophylaxis in this population. Portola's
second lead development candidate, andexanet alfa (PRT4445*), has
the potential to be the first universal antidote to reverse the
effects of Factor Xa inhibitors in patients who suffer an
uncontrolled bleeding episode or who require emergency surgery.
Portola retains full, worldwide commercial rights to andexanet
alfa. Portola's third product candidate, PRT2070, is an orally
available kinase inhibitor that uniquely inhibits two validated
tumor proliferation pathways -- spleen tyrosine kinase (Syk) and
janus kinase (JAK). It is currently being studied in patients with
genetically-defined hematologic cancers, as well as for patients
who have failed therapy due to relapse or acquired mutations.
Portola's fourth program is partnered with Biogen Idec and is
focused on the development of PRT2607, a selective Syk inhibitor.
For more information, visit www.portola.com.
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 potential efficacy and use of betrixaban, andexanet alfa and
PRT2070; development of a commercial manufacturing process for
andexanet alfa; and the statements in the section titled "Upcoming
Milestones." Risks that contribute to the uncertain nature of the
forward-looking statements include: the accuracy of Portola's
estimates regarding its ability to initiate and/or complete its
clinical trials; the success of Portola's clinical trials and the
demonstrated efficacy of Portola's product candidates thereunder;
the accuracy of Portola's estimates regarding its expenses and
capital requirements; regulatory developments in the United States
and foreign countries; Portola's ability to obtain and maintain
intellectual property protection for its product candidates; and
the loss of key scientific or management personnel. These and other
risks and uncertainties are described more fully in Portola's
filings with the Securities and Exchange Commission, including
without limitation its most recent Quarterly Report on Form 10-Q.
All forward-looking statements contained in this press release
speak only as of the date on which they were made. Portola
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
*PRT4445 has a proposed International Nonproprietary Name (pINN)
of andexanet alfa.
PORTOLA
PHARMACEUTICALS, INC. |
Unaudited Condensed
Statements of Operations Data |
(In thousands, except share and
per share data) |
|
|
|
|
|
|
Three Months
Ended September 30, |
Nine Months Ended
September 30, |
|
2013 |
2012 |
2013 |
2012 |
Collaboration and license revenue |
$ 2,766 |
$ 738 |
$ 8,474 |
$ 70,084 |
Operating expenses: |
|
|
|
|
Research and
development |
18,088 |
9,954 |
56,642 |
36,004 |
General and
administrative |
3,907 |
2,879 |
10,654 |
8,744 |
Total operating
expenses |
21,995 |
12,833 |
67,297 |
44,748 |
Income (loss) from operations |
(19,229) |
(12,095) |
(58,822) |
25,336 |
Interest and other income (expense),
net |
679 |
607 |
532 |
(188) |
Net income (loss) |
$ (18,550) |
$ (11,488) |
$ (58,290) |
$ 25,148 |
Net income (loss) attributable to common
stockholders: |
|
|
|
|
Basic |
$ (18,550) |
$ (11,488) |
$ (58,290) |
$ 322 |
Diluted |
$ (18,550) |
$ (11,488) |
$ (58,290) |
$ 462 |
Shares used to compute net income (loss) per
share attributable to common stockholders: |
|
|
|
Basic |
35,200,761 |
1,370,190 |
17,218,475 |
1,342,919 |
Diluted |
35,200,761 |
1,370,190 |
17,218,475 |
1,976,618 |
Net income (loss) per share attributable to
common stockholders: |
|
|
|
|
Basic |
$ (0.53) |
$ (8.38) |
$ (3.39) |
$ 0.24 |
Diluted |
$ (0.53) |
$ (8.38) |
$ (3.39) |
$ 0.23 |
|
PORTOLA
PHARMACEUTICALS, INC. |
Unaudited Condensed
Balance Sheet Data |
(In thousands) |
|
September 30,
2013 |
December 31,
2012 |
Cash, cash equivalents and investments |
$ 218,928 |
$ 137,384 |
Receivables from collaborations |
227 |
662 |
Total current assets |
178,672 |
134,913 |
Property and equipment, net |
2,428 |
2,861 |
Total assets |
225,367 |
146,001 |
Accounts payable |
1,517 |
4,840 |
Accrued and other liabilities |
15,960 |
7,399 |
Deferred revenue – current portion |
3,930 |
4,042 |
Total current liabilities |
23,270 |
18,824 |
Deferred revenue – noncurrent portion |
3,337 |
-- |
Total liabilities |
27,418 |
20,290 |
Total stockholders' equity
(deficit) |
197,949 |
(191,569) |
CONTACT: Investor Contact:
Alexandra Santos
Portola Pharmaceuticals
ir@portola.com
650.246.7239
Media Contact:
Joey Fleury
BrewLife
jfleury@brewlife.com
415.946.1090
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