Portola Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Corporate Update
06 Novembre 2017 - 10:01PM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) will today report
financial results and provide a corporate update for the quarter
ended September 30, 2017.
“Following FDA approval of our first product, Bevyxxa, our team
has been working diligently to bring this important new medicine to
patients in need, and we are pleased to report good progress with
the FDA on achieving product release,” said Bill Lis, chief
executive officer of Portola. “We are also continuing to advance
AndexXa, the first-ever Factor Xa inhibitor antidote. This
treatment is highly anticipated by the medical community and we are
continuing discussions with U.S. and European regulatory
authorities on our filings for this novel therapy.”
Recent Achievements, Upcoming Events and
Milestones
Betrixaban -– an oral, once-daily Factor Xa inhibitor
- Bevyxxa® (betrixaban) received U.S. Food and Drug
Administration (FDA) approval for hospital and extended duration
prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in
adult patients hospitalized for an acute medical illness who are at
risk for thromboembolic complications due to moderate or severe
restricted mobility and other risk factors for VTE
- Committee for Medicinal Products for Human Use (CHMP) opinion
anticipated by the end of 2017
- Multiple abstracts accepted at the upcoming American Heart
Association (AHA) and American Society of Hematology (ASH) annual
meetings
AndexXa® (andexanet alfa) – a Factor Xa inhibitor antidote in
development for patients treated with a Factor Xa inhibitor when
reversal of anticoagulation is needed due to life-threatening
bleeding or when urgent surgery is required; designated a
Breakthrough Therapy and an Orphan Drug by the FDA
- The FDA has set an action date of February 3, 2018 to respond
to our Biologics License Application (BLA)
- CHMP opinion anticipated in Q1 2018
- Multiple abstracts accepted at the upcoming AHA and ASH annual
meetings
Corporate
- Public offering successfully completed in September 2017, the
net proceeds of which, including exercise of the underwriters’
over-allotment option, were $380.6 million.
- Industry veteran John “Jack” Lawrence, M.D., appointed senior
vice president and chief medical officer. Dr. Lawrence previously
served as vice president and cardiovascular therapeutic area head
for Bristol-Myers Squibb, including global responsibilities for
apixaban.
Third Quarter 2017 Financial
ResultsCollaboration and license revenue earned under
Portola’s collaboration and license agreements with Bristol-Myers
Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and
Daiichi Sankyo was $3.8 million for the third quarter of 2017,
compared with $9.3 million for the third quarter of 2016.
Total operating expenses for the third quarter of 2017 were
$84.3 million, compared with $100.8 million for the same period in
2016. Total operating expenses for the third quarter of 2017
included $10.1 million in stock-based compensation expense,
compared with $7.8 million for the same period in 2016.
Research and development expenses were $55.3 million for the
third quarter of 2017, compared with $87.2 million for the third
quarter of 2016. The decrease in R&D expenses was largely
attributable to a $27.3 million one-time charge taken in the third
quarter of 2016 resulting from the Company’s decision to suspend
Line C manufacturing at CMC Biologics.
Selling, general and administrative expenses for the third
quarter of 2017 were $28.9 million, compared with $13.6 million for
the same period in 2016.
For the third quarter of 2017, Portola reported a net loss of
$82.9 million, or $1.41 net loss per share, compared with a net
loss of $92.9 million, or $1.64 net loss per share, for the same
period in 2016.
Cash, cash equivalents and investments at September 30, 2017
totaled $597.8 million, compared with cash, cash equivalents and
investments of $318.8 million as of December 31, 2016. The increase
is due to the net proceeds of $380.6 million from the Company’s
September 12, 2017 public offering.
If the FDA approves andexanet in Q1 2018, the Company will
receive an additional $100 million from its royalty-based financing
with Health Care Royalty Partners.
Conference Call Details Portola will host a
conference call today, Monday, November 6, 2017, at 4:30
p.m. Eastern Time, during which management will provide
updates on the U.S. launch of Bevyxxa, third quarter 2017 financial
results and other matters. The live call can be accessed by phone
by calling (844) 452-6828 from the United
States and Canada or (765) 507-2588 internationally
and using the passcode 7269839. 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 biopharmaceutical company developing
product candidates that could significantly advance the fields of
thrombosis and other hematologic diseases. The Company’s first
medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa
inhibitor, was approved by the U.S. Food and Drug Administration in
June 2017. The company is also working to advance two clinical
programs for AndexXa® (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
http://www.portola.com and follow the Company on Twitter
@Portola_Pharma.
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, cerdulatinib’s potential as a treatment for hematologic
cancers and the potential of Portola’s other product candidates.
Risks that contribute to the uncertain nature of the
forward-looking statements include: failure to obtain FDA and/or
EMA approval for one or more of our product candidates, regulatory
developments in the United States and foreign countries; 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 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; 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.
Unaudited Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
data) |
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Collaboration and license revenue |
|
$ |
3,828 |
|
|
$ |
9,322 |
|
|
$ |
12,743 |
|
|
$ |
21,811 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of
Sales |
|
|
155 |
|
|
|
— |
|
|
|
155 |
|
|
|
— |
|
Research
and development |
|
|
55,273 |
|
|
|
87,209 |
|
|
|
135,210 |
|
|
|
190,822 |
|
Selling, general and administrative |
|
28,856 |
|
|
|
13,556 |
|
|
|
64,206 |
|
|
|
45,374 |
|
Total
operating expenses |
|
|
84,284 |
|
|
|
100,765 |
|
|
|
199,571 |
|
|
|
236,196 |
|
Loss
from operations |
|
|
(80,456 |
) |
|
|
(91,443 |
) |
|
|
(186,828 |
) |
|
|
(214,385 |
) |
Interest and other income (expense), net |
|
663 |
|
|
|
407 |
|
|
|
952 |
|
|
|
1,036 |
|
Interest
expense |
|
|
(3,148 |
) |
|
|
— |
|
|
|
(8,243 |
) |
|
|
— |
|
Net
loss |
|
|
(82,941 |
) |
|
|
(91,036 |
) |
|
|
(194,119 |
) |
|
|
(213,349 |
) |
Net
income attributable to noncontrolling interest (SRX Cardio) |
|
|
5 |
|
|
|
(1,853 |
) |
|
|
(190 |
) |
|
|
(1,853 |
) |
Net loss
attributable to Portola |
|
$ |
(82,936 |
) |
|
$ |
(92,889 |
) |
|
$ |
(194,309 |
) |
|
$ |
(215,202 |
) |
Net loss
per share attributable to Portola common stockholders: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(1.41 |
) |
|
$ |
(1.64 |
) |
|
$ |
(3.38 |
) |
|
$ |
(3.81 |
) |
Shares
used to compute net loss per share attributable to Portola common
stockholders: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
58,940,764 |
|
|
|
56,508,426 |
|
|
|
57,569,593 |
|
|
|
56,459,418 |
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Balance Sheet
Data |
(In thousands) |
|
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
Cash, cash equivalents
and investments |
|
$ |
569,128 |
|
|
$ |
318,771 |
Prepaid
research and development |
|
|
1,888 |
|
|
|
7,299 |
Total
current assets |
|
|
579,952 |
|
|
|
328,928 |
Property
and equipment, net |
|
|
5,614 |
|
|
|
6,143 |
Intangible assets |
|
|
7,996 |
|
|
|
3,151 |
Long-term investments |
|
|
28,625 |
|
|
|
— |
Prepaid
and other long-term assets |
|
|
9,609 |
|
|
|
5,214 |
Total
assets |
|
|
631,796 |
|
|
|
343,436 |
Accounts
payable |
|
|
17,463 |
|
|
|
14,546 |
Accrued
research and development |
|
|
24,144 |
|
|
|
23,818 |
Accrued
compensation and other liabilities |
|
|
12,975 |
|
|
|
6,502 |
Deferred
revenue (current portion and long-term) |
|
|
33,020 |
|
|
|
45,763 |
Total
current liabilities |
|
|
69,769 |
|
|
|
65,664 |
Notes
payable, long-term |
|
|
52,505 |
|
|
|
49,815 |
Long
term debt |
|
|
52,388 |
|
|
|
— |
Long
term obligation to Collaborator |
|
|
8,000 |
|
|
|
8,000 |
Total
liabilities |
|
|
203,407 |
|
|
|
150,747 |
Total
Portola stockholders’ equity |
|
|
426,042 |
|
|
|
190,532 |
Noncontrolling interest (SRX Cardio) |
|
|
2,347 |
|
|
|
2,157 |
Total
stockholders’ equity |
|
|
428,389 |
|
|
|
192,689 |
Total
liabilities and stockholders’ equity |
|
|
631,796 |
|
|
|
343,436 |
|
|
|
|
|
|
|
|
Investors:Michele MantynenPortola
PharmaceuticalsIR@portola.com
Media:Patrick RyanW2O Grouppryan@w2ogroup.com
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