Portola Pharmaceuticals Reports Third Quarter 2016 Financial Results and Provides Corporate Update
November 07 2016 - 04:05PM
Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today provided a
corporate update and reported its financial results for the third
quarter ended September 30, 2016.
“We continue to focus on obtaining regulatory approval for our
two lead programs in the United States and EU. Both programs have
the potential to become the standard of care in two growth areas of
thrombosis that have a high unmet medical need and limited
treatment options. If approved, betrixaban, our oral Factor Xa
inhibitor, would be the first anticoagulant indicated for extended
VTE prophylaxis in the over 24 million medically ill patients
admitted to the hospital annually in the G7. AndexXa, our much
anticipated Factor Xa inhibitor antidote, would be the first agent
approved to treat the growing number of patients admitted to the
hospital with life-threatening anticoagulant-related bleeding. We
have made important progress toward bringing both betrixaban and
AndexXa to market. We submitted an NDA for betrixaban in the United
States and plan to submit an MAA in the EU,” said Bill Lis, chief
executive officer of Portola. “Also, we continue to engage in
positive, productive dialogue with the FDA to resolve outstanding
questions regarding the Complete Response Letter for
AndexXa, most of which are focused on
manufacturing.”
Recent Achievements, Upcoming Events and
Milestones
Betrixaban – an oral Factor Xa inhibitor anticoagulant in
development for the prevention of venous thromboembolism (VTE) in
acute medically ill patients; designated Fast Track status by the
U.S. Food and Drug Administration (FDA)
- Submitted a New Drug Application (NDA) to the FDA seeking
approval to market betrixaban for extended-duration prophylaxis of
VTE in acutely ill medical patients with risk factors for VTE
- Plan to submit a Marketing Authorization Application (MAA) with
the European Medicines Agency (EMA) by year-end
- Three abstracts on results of sub-analyses of the Phase 3 APEX
Study conducted by the PERFUSE Study Group were accepted for oral
and poster presentations at the upcoming American Heart Association
Scientific Sessions 2016
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
- Submitted an MAA, which completed the validation period and was
accepted for review by the EMA
- Continued productive dialogue with the FDA regarding the
Complete Response Letter; Portola currently plans to resubmit the
BLA in the second quarter of 2017
- Presented a preliminary analysis of interim data from the
ongoing Phase 3b/4 ANNEXA™-4 Study in patients with acute major
bleeding in a Late-Breaking Science Hot Line session at the
European Society of Cardiology 2016 Congress with simultaneous
publication online by The New England Journal of Medicine
- Plan to present data from the ongoing Phase 2 study of
andexanet alfa reversal of betrixaban in an oral presentation at
the American Society of Hematology (ASH) Annual Meeting 2016
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
- Two abstracts were accepted for presentation at the upcoming
ASH Annual Meeting 2016
Third Quarter 2016 Financial
ResultsCollaboration revenue earned under Portola's
collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer
Pharma and Janssen Pharmaceuticals, and Daiichi Sankyo was $9.3
million for the third quarter of 2016 compared with $2.9 million
for the third quarter of 2015. The increase in revenue was
primarily due to $2.5 million received upon achievement of a
milestone from the Bayer and Janssen Phase 3 agreement, $2.5
million received upon achievement of a milestone from the Daiichi
Sankyo Phase 3 agreement, and incremental revenue of $2.0 million
from three collaboration and license agreements executed in the
first quarter of 2016 to develop and commercialize andexanet alfa
in Japan.
Total operating expenses for the third quarter of 2016 were
$100.8 million compared with $58.5 million for the same period in
2015. Total operating expenses for the third quarter of 2016
included $7.8 million in stock-based compensation expense compared
with $6.1 million for the same period in 2015.
Research and development expenses were $87.2 million for the
third quarter of 2016 compared with $48.4 million for the third
quarter of 2015. The increase in R&D expenses was primarily due
to a $27.3 million impairment charge for AndexXa manufacturing
expenses that Portola prepaid to CMC Biologics. These expenses were
intended to be credited against future batch manufacturing costs
for the Line C, or 6x2,000 liter, manufacturing process. This
impairment charge was triggered by the Company’s decision to focus
on Line A/B manufacturing at CMC Biologics and Gen 2 manufacturing
at Lonza, and suspend Line C manufacturing at CMC Biologics.
Selling, general and administrative expenses for the third
quarter of 2016 were $13.6 million compared with $10.1 million for
the same period in 2015 as the Company increased headcount to
support its growth and increased commercial launch preparation
activities for AndexXa in advance of the PDUFA date in August
2016.
For the third quarter of 2016, we reported a net loss of $92.9
million dollars, or a net loss per share of $1.64, compared with a
net loss of $55.2 million dollars, or a net loss per share of
$1.05, for the same period in 2015. Net loss for the third
quarter of 2016 included the $27.3 million impairment charge.
Shares used to compute net loss per share attributable to common
stockholders were approximately 56.5 million for the third quarter
of 2016 compared with approximately 52.6 million for the same
period in 2015.
As of September 30, 2016, cash, cash equivalents and investments
totaled $274.6 million compared with cash, cash equivalents and
investments of $460.2 million as of December 31, 2015.
Conference Call Details The live conference
call today, Monday, November 7, 2016, 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 conference ID number
5031296. 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, our goal of becoming a
fully commercialized biopharmaceutical company, the projected
timing of our development, the occurrence and timing of planned
discussions and filings with the FDA and EMA and the timing of our
reporting of clinical data and statements regarding: the timing and
ability to achieve the milestones and events, including those
described under the section "Recent Achievements, Upcoming Events
and Milestones." 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
quarterly report on Form 10-Q, which we expect to file today. 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, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
Collaboration and license revenue |
|
$ |
9,322 |
|
|
$ |
2,912 |
|
|
$ |
21,811 |
|
|
$ |
7,656 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
87,209 |
|
|
|
48,405 |
|
|
|
190,822 |
|
|
|
140,563 |
|
|
Selling, general and
administrative |
|
|
13,556 |
|
|
|
10,071 |
|
|
|
45,374 |
|
|
|
27,987 |
|
|
Total operating expenses |
|
|
100,765 |
|
|
|
58,476 |
|
|
|
236,196 |
|
|
|
168,550 |
|
|
Loss from
operations |
|
|
(91,443 |
) |
|
|
(55,564 |
) |
|
|
(214,385 |
) |
|
|
(160,894 |
) |
|
Interest
and other income (expense), net |
|
|
407 |
|
|
|
406 |
|
|
|
1,036 |
|
|
|
495 |
|
|
Net
loss |
|
|
(91,036 |
) |
|
|
(55,158 |
) |
|
|
(213,349 |
) |
|
|
(160,399 |
) |
|
Net income
attributable to noncontrolling interest (SRX Cardio) |
|
|
(1,853 |
) |
|
|
— |
|
|
|
(1,853 |
) |
|
|
— |
|
|
Net loss
attributable to Portola |
|
$ |
(92,889 |
) |
|
$ |
(55,158 |
) |
|
$ |
(215,202 |
) |
|
$ |
(160,399 |
) |
|
Net loss
per share attributable to Portola common stockholders: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.64 |
) |
|
$ |
(1.05 |
) |
|
$ |
(3.81 |
) |
|
$ |
(3.12 |
) |
|
Shares used
to compute net loss per share attributable to Portola common
stockholders: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
56,508,426 |
|
|
|
52,576,005 |
|
|
|
56,459,418 |
|
|
|
51,428,117 |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet Data |
|
(In thousands) |
|
|
|
September 30, 2016 |
|
December 31, 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
Cash, cash
equivalents and investments |
|
$ |
274,597 |
|
|
$ |
460,161 |
|
|
Receivables
from collaborators |
|
|
5,000 |
|
|
|
1,000 |
|
|
Prepaid
research and development |
|
|
15,575 |
|
|
|
16,976 |
|
|
Total
current assets |
|
|
301,698 |
|
|
|
465,577 |
|
|
Property
and equipment, net |
|
|
6,384 |
|
|
|
6,243 |
|
|
Intangible
asset |
|
|
3,151 |
|
|
|
3,151 |
|
|
Prepaid and
other long-term assets |
|
|
6,316 |
|
|
|
11,993 |
|
|
Total
assets |
|
|
317,549 |
|
|
|
502,924 |
|
|
Accounts
payable |
|
|
8,993 |
|
|
|
10,279 |
|
|
Accrued
research and development |
|
|
15,433 |
|
|
|
24,195 |
|
|
Accrued
compensation and other liabilities |
|
|
5,856 |
|
|
|
8,285 |
|
|
Deferred
revenue (current portion and long-term) |
|
|
43,705 |
|
|
|
27,016 |
|
|
Total
current liabilities |
|
|
47,430 |
|
|
|
51,146 |
|
|
Total
liabilities |
|
|
76,248 |
|
|
|
72,601 |
|
|
Total
stockholders’ equity |
|
|
236,521 |
|
|
|
427,396 |
|
|
Noncontrolling interest (SRX Cardio) |
|
|
4,780 |
|
|
|
2,927 |
|
|
Total
stockholders' equity |
|
|
241,301 |
|
|
|
430,323 |
|
|
Total
liabilities and stockholders’ equity |
|
|
317,549 |
|
|
|
502,924 |
|
|
|
|
|
|
|
|
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
415.946.1087
Portola Pharmaceuticals (NASDAQ:PTLA)
Historical Stock Chart
From Feb 2024 to Mar 2024
Portola Pharmaceuticals (NASDAQ:PTLA)
Historical Stock Chart
From Mar 2023 to Mar 2024