Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today provided a
corporate update and reported its financial results for the fourth
quarter and year ended December 31, 2016.
“We are working towards gaining approval of both
betrixaban, our investigational oral Factor Xa inhibitor, and
andexanet alfa, our investigational antidote for oral Factor Xa
inhibitors, in the United States and Europe over the next year,”
said Bill Lis, chief executive officer of Portola. “Each has the
potential to become the first product approved for their respective
indications and both are highly anticipated by the medical
community. We are confident in the robust clinical data for both
products, and are focused on addressing the regulatory risks that
remain.”
Recent Achievements, Upcoming Events and
Milestones
Betrixaban – an oral Factor Xa inhibitor
anticoagulant in development for extended prophylaxis of venous
thromboembolism (VTE) in acute medically ill patients with risk
factors for VTE; designated Fast Track status by the U.S. Food and
Drug Administration (FDA)
- The FDA accepted the New Drug Application (NDA), granted
priority review, and established a Prescription Drug User Fee Act
(PDUFA) action date of June 24, 2017
- FDA informed Portola at the mid-cycle review that it does not
plan to schedule an Advisory Committee meeting to discuss the
NDA
- The European Medicines Agency (EMA) validated the Marketing
Authorization Application (MAA) under a standard 210-day review
period; the Committee for Medicinal Products for Human Use (CHMP)
opinion is expected by the end of the year
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 or uncontrolled bleeding; designated a
Breakthrough Therapy and an Orphan Drug by the FDA
- Expanded the existing agreement with Daiichi Sankyo; Portola
received a $15 million upfront payment and is eligible to receive
up to an additional $10 million upon meeting certain milestones;
upon AndexXa’s approval, Daiichi will be eligible to receive a
capped royalty
- Resubmission of the Biologics License Application (BLA) is
anticipated in the second quarter of 2017
- Continued to enroll patients in the ongoing Phase 3b/4
ANNEXA®-4 Study in patients with acute major bleeding; the Data and
Safety Monitoring Board (DSMB) successfully completed its third
review
Cerdulatinib – an oral, dual Syk/JAK inhibitor in
development to treat resistant or relapsed hematologic cancer
patients
- Continued to enroll patients in a Phase 2a study evaluating the
safety and efficacy of cerdulatinib in patients with
relapsed/refractory B-cell malignancies who have failed multiple
therapies
- Entered into an exclusive worldwide licensing agreement with
Dermavant Sciences for the development and commercialization of
cerdulatinib in topical applications beyond oncology; Portola
retains full rights to all non-topical formulations of
cerdulatinib, including oral formulations
Corporate
- Entered into a $50 million loan agreement with Bristol-Myers
Squibb Company and Pfizer Inc. for continued development and
clinical studies of andexanet alfa
- Entered into a $150 million royalty agreement in the first
quarter of 2017 with HealthCare Royalty Partners in exchange for a
tiered, mid-single-digit royalty based on worldwide andexanet alfa
sales
Fourth Quarter and Year-End Financial
ResultsCollaboration and license revenue earned under
Portola's collaboration and license agreements with Bristol-Myers
Squibb Company and Pfizer, Bayer Pharma and Janssen
Pharmaceuticals, Daiichi Sankyo and Dermavant Sciences was $13.7
million for the fourth quarter of 2016 compared with $4.4 million
for the fourth quarter of 2015. Collaboration and license revenue
for the year ended December 31, 2016, was $35.5 million compared
with $12.1 million for the year ended December 31, 2015.
Total operating expenses for the fourth quarter of
2016 were $68.9 million compared with $70.7 million for the same
period in 2015. Total operating expenses for the fourth quarter of
2016 included $7.9 million in stock-based compensation expense
compared with $6.8 million for the same period in 2015. Total
operating expenses for the year ended December 31, 2016, were
$305.1 million compared with $239.2 million for 2015. Total
operating expenses for the full year ended December 31, 2016,
included $30.4 million in stock-based compensation expense compared
with $22.9 million for 2015.
Research and development expenses for the fourth
quarter of 2016 were $56.0 million compared with $59.8 million for
the same period in 2015. Research and development expenses were
$246.9 million for the year ended December 31, 2016, compared with
$200.4 million for 2015. The increase in R&D expenses was
primarily due to increased program costs to advance andexanet alfa
of $64.7 million, including a $27.3 million one-time charge to
write off certain prepaid manufacturing costs and increased program
costs to support cerdulatinib and early research programs of $3.8
million, partially offset by decreased program costs related to
betrixaban of $22.0 million following the completion of the
APEX clinical trial enrollment.
Selling, general and administrative expenses for
the fourth quarter of 2016 were $12.9 million compared with $10.9
million for the same period in 2015. Selling, general and
administrative expenses for the year ended December 31, 2016, were
$58.2 million compared with $38.9 million for 2015. The increase in
SG&A expenses was primarily due to increased headcount-related
costs, commercial launch preparation activities and business
development-related costs, and costs associated with professional
and accounting fees of $2.0 million.
For the fourth quarter of 2016, Portola reported a
net loss of $53.8 million, or $0.95 net loss per share, compared
with a net loss of $66.1 million, or $1.23 net loss per share, for
the same period in 2015. Shares used to compute net loss per share
attributable to common stockholders were 56.5 million for the
fourth quarter of 2016 compared with 53.6 million for the same
period in 2015. Net loss for the year ended December 31, 2016, was
$269.0 million, or $4.76 net loss per share, compared with a net
loss of $226.5 million, or $4.36 net loss per share, for the same
period in 2015. Shares used to compute net loss per share
attributable to common stockholders were 56.5 million for 2016
compared with 52.0 million for 2015.
Cash, cash equivalents and investments at December
31, 2016, totaled $318.8 million compared with cash, cash
equivalents and investments of $460.2 million as of December 31,
2015.
2017 Annual Financial GuidanceFor
the fiscal year 2017, Portola expects total GAAP operating expenses
to be between $323 million and $344 million. For the fiscal year
2017, Portola expects total pro-forma operating expenses to be
between $290 million and $310 million, excluding stock-based
compensation. These expenses will be primarily for manufacturing of
both andexanet and betrixaban, support of ongoing clinical trials
and preparation for the potential commercial launches of betrixaban
and AndexXa.
Non-GAAP Financial ProjectionThis
press release and the reconciliation table included herein include
a non-GAAP projection of 2017 operating expenses, excluding
stock-based compensation. A reconciliation to projected GAAP 2017
operating expenses is provided in the accompanying table entitled
"Reconciliation of GAAP to Non-GAAP Projected Operating Expenses."
Portola management believes this non-GAAP information is useful for
investors because it provides information about the Company's
ability to independently fund and advance its operations with
existing capital resources. Share-based compensation is not an
expense that requires cash settlement, and therefore, the Company
excludes these charges for purposes of evaluating our ability to
fund future operations.
Conference Call Details The live
conference call today, Tuesday, February 28, 2017,
at 4:30 p.m. Eastern Time, can be accessed by phone by calling
(844) 452-6828 from the United
States and Canada or 1 (765)-507-2588
internationally and using the passcode 71935945. 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 is advancing three programs,
including betrixaban, an oral, once-daily Factor Xa inhibitor;
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
www.portola.com and follow the Company on Twitter
@Portola_Pharma.
Forward-looking
Statements 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,
anticipated product approvals, the potential of our product
candidates to advance the field of thrombosis and benefit patients
and the timing of our regulatory events and statements regarding
the timing and ability to achieve other milestones and events,
including those described under the section "Recent Achievements,
Upcoming Events and Milestones" and “2017 Annual Financial
Guidance." 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, 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; 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
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 December 31, |
|
Twelve Months Ended December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
Collaboration and license revenue |
|
$ |
13,693 |
|
|
$ |
4,414 |
|
|
$ |
35,504 |
|
|
$ |
12,070 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
56,032 |
|
|
|
59,814 |
|
|
|
246,854 |
|
|
|
200,376 |
|
|
Selling,
general and administrative |
|
|
12,861 |
|
|
|
10,881 |
|
|
|
58,235 |
|
|
|
38,869 |
|
|
Total operating expenses |
|
|
68,893 |
|
|
|
70,695 |
|
|
|
305,089 |
|
|
|
239,245 |
|
|
Loss
from operations |
|
|
(55,200 |
) |
|
|
(66,281 |
) |
|
|
(269,585 |
) |
|
|
(227,175 |
) |
|
Interest
and other income (expense), net |
|
|
436 |
|
|
|
(190 |
) |
|
|
1,472 |
|
|
|
305 |
|
|
Loss
before taxes |
|
|
(54,764 |
) |
|
|
(66,471 |
) |
|
|
(268,113 |
) |
|
|
(226,870 |
) |
|
Income
tax benefit |
|
|
— |
|
|
|
365 |
|
|
|
— |
|
|
|
365 |
|
|
Net
loss |
|
|
(54,764 |
) |
|
|
(66,106 |
) |
|
|
(268,113 |
) |
|
|
(226,505 |
) |
|
Net
income attributable to noncontrolling interest (SRX Cardio) |
|
|
923 |
|
|
|
— |
|
|
|
(930 |
) |
|
|
— |
|
|
Net loss
attributable to Portola |
|
$ |
(53,841 |
) |
|
$ |
(66,106 |
) |
|
$ |
(269,043 |
) |
|
$ |
(226,505 |
) |
|
Net loss
per share attributable to Portola common stockholders: |
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(0.95 |
) |
|
$ |
(1.23 |
) |
|
$ |
(4.76 |
) |
|
$ |
(4.36 |
) |
|
Shares
used to compute net loss per share attributable to Portola common
stockholders: |
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
56,543,875 |
|
|
|
53,623,313 |
|
|
|
56,480,647 |
|
|
|
51,981,463 |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet
Data |
(In thousands) |
|
|
December 31, 2016 |
|
December 31, 2015 |
|
|
(Unaudited) |
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
318,771 |
|
$ |
460,161 |
Receivables from
collaborators |
|
|
— |
|
|
1,000 |
Prepaid research and
development |
|
|
7,299 |
|
|
16,976 |
Total current
assets |
|
|
328,928 |
|
|
465,577 |
Property and equipment,
net |
|
|
6,143 |
|
|
6,243 |
Intangible asset |
|
|
3,151 |
|
|
3,151 |
Prepaid and other
long-term assets |
|
|
5,214 |
|
|
11,993 |
Total assets |
|
|
343,436 |
|
|
502,924 |
Accounts payable |
|
|
14,546 |
|
|
10,279 |
Accrued research and
development |
|
|
23,818 |
|
|
24,195 |
Accrued compensation
and other liabilities |
|
|
6,502 |
|
|
8,285 |
Deferred revenue
(current portion and long-term) |
|
|
45,763 |
|
|
27,016 |
Total current
liabilities |
|
|
65,664 |
|
|
51,146 |
Long term obligation to
Collaborator |
|
|
8,000 |
|
|
- |
Notes payable,
long-term |
|
|
50,061 |
|
|
- |
Total liabilities |
|
|
150,747 |
|
|
72,601 |
Total stockholders’
equity |
|
|
190,532 |
|
|
427,396 |
Noncontrolling interest
(SRX Cardio) |
|
|
2,157 |
|
|
2,927 |
Total stockholders'
equity |
|
|
192,689 |
|
|
430,323 |
Total liabilities and
stockholders’ equity |
|
|
343,436 |
|
|
502,924 |
Reconciliation
of GAAP to Non-GAAP Projected Operating
Expenses |
|
|
|
|
(in millions) |
|
|
|
|
|
|
|
|
|
|
|
Low |
|
High |
|
|
|
|
|
2017 Projected Operating Expenses-GAAP |
|
$ |
323 |
|
$ |
344 |
Stock-based compensation expenses |
|
|
33 |
|
|
34 |
2017 Projected Operating Expenses-Non-GAAP |
|
|
290 |
|
|
310 |
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
Pure Communications
jnormart@purecommunications.com
415.946.1087
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