--Conference Call Today at 4:30 p.m. ET--
Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today reported
financial results for the fourth quarter and full year
ended December 31, 2017 and provided a corporate update.
“2017 was a year of significant achievement for
Portola, highlighted by the FDA approval of our first medicine,
Bevyxxa, and the regulatory application for FDA approval of our
breakthrough-designated Factor Xa-inhibitor antidote, AndexXa,”
said Bill Lis, chief executive officer of Portola. “We are pleased
with the early indicators of the U.S. commercial launch of Bevyxxa,
which began in January, and the potential to have a major public
health impact on millions of patients in the U.S. and beyond. We
also are rapidly approaching the FDA action date for AndexXa,
which, if approved, would position Portola with two first-in-class
medicines in the field of thrombosis. In the meantime, we are
working with European regulatory authorities on the path forward
for both medicines and are continuing to advance our dual, oral
Syk/JAK inhibitor, cerdulatinib, for hematologic cancers.”
Recent Achievements, Upcoming Events and
Milestones
Bevyxxa® (betrixaban) – an 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 of Bevyxxa in January
2018
- Received FDA approval for the manufacturing of betrixaban in
Cork, Ireland
- Completed an oral explanation to the European Committee for
Medicinal Products for Human Use (CHMP); determining next steps in
light of negative CHMP trend vote
- New APEX trial results published in The American Heart Journal
showing betrixaban’s effect on symptomatic VTE and VTE-related
deaths; 12th major peer-reviewed publication
AndexXa® (andexanet alfa) – an antidote for
Factor Xa inhibitor treated patients with life-threatening
bleeding; designated a Breakthrough Therapy and an Orphan Drug by
the FDA.
- The FDA set a new action date of May 4,
2018 for the Biologics License Application (BLA)
- Successfully completed the first commercial campaign for Gen 2
product
- Enrollment remains on track for the ongoing Phase 3b/4 ANNEXA-4
study in patients with acute major bleeding
- Late-breaking clinical trial presentation on March 12, 2018 at
the American College of Cardiology’s 67th
Annual Scientific Session & Expo (ACC.18) featuring
new interim data from ANNEXA-4
- Successfully completed an oral explanation to the European
CHMP; received a positive CHMP trend vote and are working with
regulatory authorities to address their accompanying request for
additional data
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.
- Continued to enroll patients in a 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
Fourth Quarter and Full Year 2017
Financial ResultsCollaboration and license revenue earned
under Portola’s collaboration and license agreements
with Bristol-Myers Squibb Company, Pfizer, Bayer
Pharma, Janssen Pharmaceuticals, Daiichi Sankyo and
Dermavant Sciences was $9.8 million for the fourth
quarter of 2017, compared with $13.7 million for the
fourth quarter of 2016. Collaboration and license revenue for the
year ended December 31, 2017 was $22.5
million, compared with $35.5 million for the year
ended December 31, 2016.
Total operating expenses for the fourth quarter
of 2017 were $95.7 million, compared with $68.9
million for the same period in 2016. Total operating expenses
for the fourth quarter of 2017 included $10.9 million in
stock-based compensation expense, compared with $7.9
million for the same period in 2016. Total operating expenses
for the year ended December 31, 2017 were $295.2
million, compared with $305.1 million for 2016.
Total operating expenses for the full year ended December 31,
2017 included $43.3 million in stock-based compensation
expense compared with $30.4 million for 2016.
Research and development expenses
were $68.5 million for the fourth quarter of 2017,
compared with $56.0 million for the fourth quarter of
2016. Research and development expenses were $203.7 million for the
year ended December 31, 2017, compared with $246.9 million for
2016.
Selling, general and administrative expenses for
the fourth quarter of 2017 were $26.9 million, compared
with $12.9 million for the same period in 2016. Selling,
general and administrative expenses for the year ended December 31,
2017 were $91.1 million, compared with $58.2 million for 2016.
For the fourth quarter of 2017, Portola reported
a net loss of $91.8 million, or $1.41 net loss per
share, compared with a net loss of $53.8 million,
or $0.95 net loss per share, for the same period in 2016.
Shares used to compute net loss per share attributable to common
stockholders were $65.3 million for the fourth quarter of 2017
compared with $56.5 million for the same period in 2016. Net loss
for the year ended December 31, 2017 was $286.1 million, or $4.81
net loss per share, compared with a net loss of $269.0 million, or
$4.76 net loss per share, for the same period in 2016. Shares used
to compute net loss per share attributable to common stockholders
were $59.5 million for 2017 compared with $56.5 million for
2016.
Cash, cash equivalents and investments
at December 31, 2017 totaled $534.2 million, compared
with cash, cash equivalents and investments of $318.8
million as of December 31, 2016.
If the FDA approves andexanet alfa in Q2 2018,
the Company will be entitled to receive an additional $100 million
from its royalty-based financing with Health Care Royalty
Partners.
2018 Annual Financial
GuidanceFor the fiscal year 2018, Portola expects total
GAAP operating expenses to be between $390 million and $430
million, including stock based compensation. These expenses are
primarily for manufacturing of both andexanet alfa and betrixaban,
ongoing clinical trials, support for the commercial launch of
Bevyxxa and preparation for the potential commercial launch of
AndexXa.
Conference Call DetailsPortola
will host a conference call today, Wednesday, February 28,
2018, at 4:30 p.m. ET, during which time management will
provide fourth quarter and full year 2017 financial results,
updates on the U.S. launch of Bevyxxa and other matters. The live
call can be accessed by phone by dialing (844) 452-6828
from the United States and Canada or 1 (765)
507-2588 internationally and using the passcode 4893459. 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 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,
statements regarding the potential public health impact and
commercial success of Bevyxxa, regulatory approval of andexanet
alfa, projected operating expenses for 2018 and cerdulatinib’s
potential as a treatment for hematologic cancers. 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.
Investor Contact:Cara MillerPortola
Pharmaceuticalsir@portola.com
Media Contact:Laurie MasonsonW2O
Grouplmasonson@w2ogroup.com
| |
| Unaudited Condensed Consolidated Statements of
Operations |
| (In thousands, except share and per share
data) |
| |
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
Collaboration and license revenue |
$ |
9,803 |
|
|
$ |
13,693 |
|
|
$ |
22,546 |
|
|
$ |
35,504 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
| Cost of
sales |
|
260 |
|
|
|
— |
|
|
|
415 |
|
|
|
— |
|
| Research
and development |
|
68,491 |
|
|
|
56,032 |
|
|
|
203,701 |
|
|
|
246,854 |
|
| Selling,
general and administrative |
|
26,903 |
|
|
|
12,861 |
|
|
|
91,109 |
|
|
|
58,235 |
|
| Total
operating expenses |
|
95,654 |
|
|
|
68,893 |
|
|
|
295,225 |
|
|
|
305,089 |
|
| Loss
from operations |
|
(85,851 |
) |
|
|
(55,200 |
) |
|
|
(272,679 |
) |
|
|
(269,585 |
) |
| Interest
and other income (expense), net |
|
(2,290 |
) |
|
|
497 |
|
|
|
(1,338 |
) |
|
|
1,533 |
|
| Interest
expense |
|
(3,360 |
) |
|
|
(61 |
) |
|
|
(11,603 |
) |
|
|
(61 |
) |
| Loss
before taxes |
|
(91,501 |
) |
|
|
(54,764 |
) |
|
|
(285,620 |
) |
|
|
(268,113 |
) |
| Income
tax benefit |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Net
loss |
|
(91,501 |
) |
|
|
(54,764 |
) |
|
|
(285,620 |
) |
|
|
(268,113 |
) |
| Net loss
(income) attributable to noncontrollinginterest (SRX Cardio) |
|
(280 |
) |
|
|
923 |
|
|
|
(470 |
) |
|
|
(930 |
) |
| Net loss
attributable to Portola |
$ |
(91,781 |
) |
|
$ |
(53,841 |
) |
|
$ |
(286,090 |
) |
|
$ |
(269,043 |
) |
| Net loss
per share attributable to Portola commonstockholders: |
|
|
|
|
|
|
|
| Basic and
diluted |
$ |
(1.41 |
) |
|
$ |
(0.95 |
) |
|
$ |
(4.81 |
) |
|
$ |
(4.76 |
) |
| Shares
used to compute net loss per shareattributable to Portola common
stockholders: |
|
|
|
|
|
|
|
| Basic and
diluted |
|
65,260,653 |
|
|
|
56,543,875 |
|
|
|
59,508,156 |
|
|
|
56,480,647 |
|
|
|
|
|
|
|
|
|
|
| Consolidated Balance Sheet Data |
|
| (In thousands) |
|
|
|
December 31, 2017 |
|
December 31, 2016 |
|
| |
(Unaudited) |
|
| |
|
|
|
|
| Cash,
cash equivalents and investments |
$ |
534,233 |
|
$ |
318,771 |
|
|
Receivables from collaborators |
|
3,750 |
|
|
— |
|
| Prepaid
research and development |
|
734 |
|
|
7,299 |
|
| Total
current assets |
|
477,923 |
|
|
328,928 |
|
| Property
and equipment, net |
|
5,217 |
|
|
6,143 |
|
|
Intangible assets |
|
7,851 |
|
|
3,151 |
|
| Prepaid
and other long-term assets |
|
9,609 |
|
|
5,214 |
|
| Total
assets |
|
571,676 |
|
|
343,436 |
|
| Accounts
payable |
|
9,304 |
|
|
14,546 |
|
| Accrued
research and development |
|
44,973 |
|
|
23,818 |
|
| Accrued
compensation and other liabilities |
|
15,078 |
|
|
6,502 |
|
| Deferred
revenue (current portion and long-term) |
|
29,967 |
|
|
45,763 |
|
| Total
current liabilities |
|
80,524 |
|
|
65,664 |
|
| Long
term obligation to Collaborator |
|
8,000 |
|
|
8,000 |
|
| Notes
payable, long-term and Long-term debt |
|
104,816 |
|
|
49,815 |
|
| Total
liabilities |
|
222,183 |
|
|
150,747 |
|
| Total
Portola stockholders’ equity |
|
346,866 |
|
|
190,532 |
|
|
Noncontrolling interest (SRX Cardio) |
|
2,627 |
|
|
2,157 |
|
| Total
stockholders' equity |
|
349,493 |
|
|
192,689 |
|
| Total
liabilities and stockholders’ equity |
|
571,676 |
|
|
343,436 |
|
|
|
|
|
|
|
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