Portola Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Corporate Update
09 Mai 2018 - 10:05PM
-- Conference Call Today at 4:30 p.m. ET --
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today reported
financial results for the three months ended March 31, 2018
and provided a corporate update.
“We achieved several major manufacturing and
regulatory milestones this past year, including last week’s
U.S. approval of Andexxa®. We are now concentrating the Company’s
efforts on the successful launch of Andexxa and Bevyxxa®, which
both have the potential to impact public health and become
standards of care in the field of thrombosis,” said Bill Lis, chief
executive officer of Portola. “We are also encouraged by
interim data for our next compound for hematologic cancers,
cerdulatinib, which will be presented next month at the American
Society of Clinical Oncology Annual Meeting. Together, these three
compounds comprise a leading thrombosis and hematology portfolio,
all with global rights.”
Recent Achievements, Upcoming Events and
Milestones
Andexxa [coagulation factor Xa
(recombinant), inactivated-zhzo] – antidote for the reversal of the
Factor Xa inhibitors rivaroxaban and apixaban.
- Andexxa received Accelerated Approval from the FDA on May 3,
2018 for patients treated with rivaroxaban and apixaban, when
reversal of anticoagulation is needed due to life-threatening or
uncontrolled bleeding.
- Earned an additional $100 million milestone payment from the
Company’s royalty-based financing with Health Care Royalty Partners
based on the FDA approval of Andexxa in May 2018.
- Early Supply Program to launch in June with broader commercial
launch anticipated in early 2019, upon FDA approval of the
Generation 2 product.
- Presented interim data from the ongoing Phase 3b/4 ANNEXA-4
study in a late-breaking clinical trial presentation at the
American College of Cardiology’s 67th Annual Scientific
Session & Expo (ACC.18). Enrollment on track for
completion this summer.
- Received a positive CHMP trend vote and working with regulatory
authorities to address their accompanying request for additional
data.
- Built significant Generation 2 product inventory to meet broad
demand upon regulatory approval in the U.S. and Europe.
Bevyxxa (betrixaban) – oral, once-daily Factor
Xa inhibitor approved for extended prophylaxis of venous
thromboembolism (VTE) in acute medically ill patients with risk
factors for VTE.
- Initiated U.S. commercial launch and continued to expand the
field force and market access teams.
- Additional results from the APEX trial published in the
American Heart Journal and the American Journal of Medicine
continue to highlight betrixaban’s effect on symptomatic VTE and
VTE-related deaths.
- Eight abstracts accepted at the upcoming International Society
on Thrombosis and Haemostasis (ISTH) and European Society of
Cardiology (ESC) meetings.
Cerdulatinib – an oral, dual-spleen tyrosine
kinase (SYK) and janus kinase (JAK) inhibitor in development for
the treatment of relapsed/refractory B-cell and other T-cell
malignancies in patients who have failed multiple therapies.
- Completed enrollment in two of four cohorts of the ongoing
Phase 2a study evaluating the safety and efficacy of cerdulatinib
in patients with relapsed/refractory B-cell and T-cell malignancies
who have failed multiple therapies.
- Interim results from the ongoing Phase 2a study accepted for
presentation at the 2018 American Society of Clinical Oncology
(ASCO) Annual Meeting.
- Received initial feedback from the FDA on the potential
regulatory pathway.
First Quarter 2018 Financial
ResultsTotal revenue for the first quarter of 2018 was
$6.6 million, compared with $5.1 million for the first quarter of
2017. This includes $6.0 million in collaboration and license
revenue earned under Portola’s collaboration and license agreements
with Bristol-Myers Squibb Company, Pfizer, Bayer
Pharma, Janssen Pharmaceuticals and Daiichi Sankyo, as
well as $0.6 million in product revenue from initial sales of
Bevyxxa, which was launched in the U.S. in January 2018.
Total operating expenses for the first quarter
of 2018 were $91.9 million, compared with $45.7
million for the same period in 2017. Total operating expenses
for the first quarter of 2018 included $11.0 million in
stock-based compensation expense, compared with $9.0
million for the same period in 2017.
Research and development expenses
were $60.1 million for the first quarter of 2018,
compared with $30.6 million for the first quarter of
2017. The increase is due to the second Generation 2 commercial
manufacturing campaign. Selling, general and administrative
expenses for the first quarter of 2018 were $31.5 million,
compared with $15.0 million for the same period in
2017. The increase is due to the build-out of the field force
and marketing spend for the Bevyxxa launch.
For the first quarter of 2018, Portola reported
a net loss of $84.2 million, or $1.28 net loss per
share, compared with a net loss of $41.7 million,
or $0.74 net loss per share, for the same period in 2017.
Shares used to compute net loss per share attributable to common
stockholders were 65.5 million for the first quarter of 2018
compared with 56.7 million for the same period in 2017.
Cash, cash equivalents and investments
at March 31, 2018 totaled $451.1 million, compared with
cash, cash equivalents and investments of $534.2
million as of December 31, 2017.
Based on the FDA approval of Andexxa
in May 2018, the Company earned an additional $100
million milestone payment from its royalty-based financing
with Health Care Royalty Partners.
Conference Call DetailsPortola
will host a conference call today, Wednesday, May 9, 2018,
at 4:30 p.m. ET, during which time management will provide
first quarter 2018 financial results, updates on Andexxa, the U.S.
launch of Bevyxxa and other matters. The live call can be accessed
by phone by dialing (844) 452-6828 from the
U.S. and Canada or 1 (765) 507-2588 internationally
and using the passcode 7068059. The webcast can be accessed live on
the Investor Relations section of the Company's website
at http://investors.portola.com. It will be archived for 30
days following the call.
About Portola Pharmaceuticals,
Inc.Portola Pharmaceuticals is a commercial-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel therapeutics that could significantly
advance the fields of thrombosis and other hematologic diseases.
The Company’s two FDA-approved medicines are Bevyxxa® (betrixaban),
the first and only oral, once-daily Factor Xa inhibitor, and
Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo],
the first and only antidote for the Factor Xa inhibitors
rivaroxaban and apixaban. The company also is advancing
cerdulatinib, a SYK/JAK inhibitor for the treatment of hematologic
cancers.
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. 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 public health impact of Andexxa
and Bevyxxa, the timing of the anticipated Early Supply Program
launch of Andexxa, our plans to present cerdulatinib interim Phase
2a clinical trial results and our expected receipt of an additional
$100 million in royalty-based financing investment. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the risk that physicians, patients and payers
may not see the benefits of utilizing Andexxa or Bevyxxa for the
indications which they are approved; our ability to continue to
manufacture our products and to expand approved manufacturing
facilities; the possibility of unfavorable results from additional
clinical trials involving Andexxa; the risk that the EMA may not
approve Andexxa in the currently anticipated timelines or at all,
and that any marketing approvals or reimbursement limitations may
have significant limitations on its use; the risk that Portola may
not obtain additional regulatory approvals necessary to expand
approved indications for Andexxa; 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 expenses and capital requirements; our ability to
successfully build a hospital-based sales force and commercial
infrastructure; 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 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. 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.
Investor
Contact: |
Media
Contact: |
Cara Miller |
Laurie Masonson |
Portola
Pharmaceuticals
|
Pure
Communications |
ir@portola.com |
lmasonson@purecommunications.com |
|
|
Unaudited Condensed Consolidated Statements of
Operations |
|
(In thousands, except share and per share
data) |
|
|
|
Three Months Ended March 31, |
|
|
|
2018 |
|
2017 |
|
Revenues: |
|
|
|
|
|
Product
revenue, net |
|
$ |
606 |
|
|
$ |
— |
|
|
Collaboration and license revenue |
|
|
6,038 |
|
|
|
5,128 |
|
|
Total
revenues |
|
|
6,644 |
|
|
|
5,128 |
|
|
Operating expenses: |
|
|
|
|
|
Cost of
Sales |
|
|
336 |
|
|
|
— |
|
|
Research
and development |
|
|
60,067 |
|
|
|
30,645 |
|
|
Selling,
general and administrative |
|
|
31,541 |
|
|
|
15,021 |
|
|
Total
operating expenses |
|
|
91,944 |
|
|
|
45,666 |
|
|
Loss
from operations |
|
|
(85,300 |
) |
|
|
(40,538 |
) |
|
Interest
and other income, net |
|
|
3,371 |
|
|
|
413 |
|
|
Interest
expense |
|
|
(2,581 |
) |
|
|
(1,639 |
) |
|
Net
loss |
|
|
(84,510 |
) |
|
|
(41,764 |
) |
|
Net loss
attributable to noncontrolling interest (SRX Cardio) |
|
|
332 |
|
|
|
45 |
|
|
Net loss
attributable to Portola |
|
$ |
(84,178 |
) |
|
$ |
(41,719 |
) |
|
Net loss
per share attributable to Portola common stockholders: |
|
|
|
|
|
Basic and
diluted |
|
$ |
(1.28 |
) |
|
$ |
(0.74 |
) |
|
Shares
used to compute net loss per share attributable to Portola common
stockholders: |
|
|
|
|
|
Basic and
diluted |
|
|
65,509,945 |
|
|
|
56,692,788 |
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Balance Sheet
Data |
|
(In thousands) |
|
|
|
|
|
March 31, 2018 |
|
December 31, 2017 |
|
|
(Unaudited) |
|
Cash, cash equivalents
and investments |
|
$ |
451,085 |
|
|
$ |
534,233 |
|
Prepaid
research and development |
|
|
3,449 |
|
|
|
734 |
|
Trade
and other receivables, net |
|
|
1,693 |
|
|
|
3,750 |
|
Unbilled
- collaboration and license revenue |
|
|
4,660 |
|
|
|
— |
|
Total
current assets |
|
|
436,237 |
|
|
|
477,923 |
|
Property
and equipment, net |
|
|
5,393 |
|
|
|
5,217 |
|
Intangible assets |
|
|
7,710 |
|
|
|
7,851 |
|
Prepaid
and other long-term assets |
|
|
4,812 |
|
|
|
9,609 |
|
Total
assets |
|
|
496,666 |
|
|
|
571,676 |
|
Accounts
payable |
|
|
20,788 |
|
|
|
9,304 |
|
Accrued
research and development |
|
|
22,105 |
|
|
|
44,973 |
|
Accrued
compensation and other liabilities |
|
|
10,754 |
|
|
|
15,078 |
|
Deferred
revenue (current portion and long-term) |
|
|
9,273 |
|
|
|
29,967 |
|
Total
current liabilities |
|
|
57,508 |
|
|
|
80,524 |
|
Notes
payable, long-term and Long-term debt |
|
|
107,397 |
|
|
|
104,816 |
|
Long
term obligation to Collaborator |
|
|
8,000 |
|
|
|
8,000 |
|
Total
liabilities |
|
|
186,498 |
|
|
|
222,183 |
|
Total
Portola stockholders’ equity |
|
|
307,992 |
|
|
|
346,866 |
|
Noncontrolling interest (SRX Cardio) |
|
|
2,176 |
|
|
|
2,627 |
|
Total
stockholders’ equity |
|
|
310,168 |
|
|
|
349,493 |
|
Total
liabilities and stockholders’ equity |
|
|
496,666 |
|
|
|
571,676 |
|
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