SOUTH SAN FRANCISCO, Calif.,
Feb. 26, 2020 /PRNewswire/
-- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA)
today reported financial results for the fourth quarter and full
year ended December 31, 2019.
"2019 was a year of significant accomplishments for Portola with the launch of our Gen 2
formulation of Andexxa in the United
States and the approval and launch of Ondexxya in
Europe. In 2020 we have several
catalysts that we expect to drive further adoption and growth
worldwide," said Scott Garland,
Portola's president and chief
executive officer. "This includes the presentation of new clinical
data, enhanced education and support related to reimbursement, the
initiation of our urgent surgery study, and continued execution of
the Ondexxya launch in Europe.
Combined with the robust growth in the Factor Xa inhibitor market
and our other strategic initiatives, we are confident that Andexxa
has significant long-term growth potential."
Quarter Ending December 31,
2019, and Full-Year 2019 Financial Results
- Total global revenues for the fourth quarter of 2019
were $29.2 million compared with $15.3 million for
the fourth quarter of 2018. This includes $28.4
million in net product revenues from sales of Andexxa/Ondexxya
[coagulation factor Xa (recombinant), inactivated-zhzo],
and $0.9 million in collaboration and license revenues.
Total global revenues for the full year 2019 were $116.6
million compared with $40.1 million for the full year
2018. This includes $111.5 million in net product
revenues from sales of Andexxa/Ondexxya, and $5.0
million in collaboration and license revenues.
- Net loss attributable to Portola was $96.7 million, or $1.24
net loss per share for the fourth quarter of 2019, compared with a
net loss of $88.5 million, or $1.34 net loss per
share, for the same period in 2018. Net loss attributable to
Portola was $290.7 million,
or $4.06 net loss per share for the full year 2019, compared
with a net loss of $350.2 million, or $5.31 net loss
per share, for the full year 2018. This includes the effect of a
$27.5 million charge taken in the
fourth quarter of 2019 for Bevyxxa inventory and manufacturing
related to the decision to discontinue the commercialization of
Bevyxxa, and a $3.2 million
impairment charge taken in the second quarter of 2019 related to
the discontinuation of our SRX program.
- Non-GAAP net loss for the fourth quarter of 2019 was
$58.3 million, or a non-GAAP basic
and diluted loss per share of $0.75.
For the full year 2019, non-GAAP net loss was $198.2 million, or a non-GAAP basic and diluted
loss per share of $2.77. Non-GAAP net
loss and loss per share have been adjusted to exclude the Bevyxxa
inventory and manufacturing charge and an impairment charge as well
as stock-based compensation expenses. Please see the reconciliation
of GAAP to non-GAAP financial measures at the end of this release
for more details.
- Total operating expenses for the fourth quarter of 2019
were $119.4 million compared with $102.5 million for
the same period in 2018. Total operating expenses for the full year
2019 were $387.9 million, compared with $385.5
million for the full year 2018.
- Non-GAAP total operating expenses, which excludes the Bevyxxa
inventory and manufacturing charge and impairment charge as well as
stock based compensation expenses, were $81.1 million for the fourth quarter of 2019, and
$295.5 million for the full year
2019. Please see the reconciliation of GAAP to non-GAAP financial
measures table at the end of this release for more details.
- Research and development (R&D) expenses were $29.9 million for the fourth quarter of 2019,
compared with $49.5 million for the
fourth quarter of 2018. R&D expenses for the full year 2019
were $124.6 million, compared with
$216.2 million, for the full year
2018. The decrease in both periods is primarily due to the
manufacturing costs for Andexxa Gen 2 being capitalized and no
longer flowing through R&D.
- Selling, general and administrative (SG&A) expenses for the
fourth quarter 2019 were $60.0
million compared with $40.6
million for the fourth quarter of 2018. SG&A expenses
for the full year 2019 were $218.9
million compared with $151.2
million for the full year 2018. The increase in both periods
is due to commercial costs to support the launch of Andexxa,
including the expansion of the field sales teams and support for
the launch of Ondexxya in Europe.
- Cost of sales (COS) for the fourth quarter of 2019 was
$29.6 million compared to
$12.4 million for the same period in
2018. COS for the full year 2019 was $44.4
million compared with $18.1
million for the full year 2018. The increase in both periods
is due to a charge for Bevyxxa inventory and manufacturing as the
Company winds down that program.
- Please see the GAAP to non-GAAP reconciliation table at the end
of this release for a detailed breakdown.
Cash, Cash Equivalents and Investments:
- Cash, cash equivalents and investments at December 31,
2019, totaled $466.2 million, compared with $317.0
million as of December 31, 2018. During the fourth
quarter, the Company drew down the remaining $62.5 million available under its $125.0 million loan agreement with HealthCare
Royalty Partners (HCR) and investment funds manager Athyrium
Capital Management, LP.
2020 Annual Financial Guidance
For the fiscal year 2020, Portola expects total R&D expenses to be
between $105 million and $120
million, including stock-based compensation expenses of
approximately $14 million.
Portola expects total SG&A
expenses to be between $235 million
and $250 million, including
stock-based compensation expenses of approximately $38 million.
Recent Achievements and Events
- Completed an internal restructuring to align resources to drive
Andexxa growth including the discontinuation of commercialization
and partnering efforts for Bevyxxa. In addition, the Company has
decided not to initiate the CELTIC-1 trial for the SYK/JAK
inhibitor cerdulatinib until a partner is identified.
- Initiated the single-arm urgent surgery study for Andexxa,
ANNEXA-S.
- Andexxa was highlighted as a first-line Factor Xa reversal
option by the American College of Emergency Physicians in
recommendations published in the Annals of Emergency
Medicine, bringing the total number of guideline inclusions to
19.
- Presented multiple abstracts related to cerdulatinib at the
American Society of Hematology 2019 Annual Meeting in December. The
data demonstrated good tolerability and clinical response in
patients with relapsed/refractory peripheral T-cell lymphoma (PTCL)
and cutaneous T-cell lymphoma (CTCL), including a 52% overall
response rate in patients with angioimmunoblastic T-cell lymphoma
(AITL), and a 76% overall response rate in patients with follicular
lymphoma treated with cerdulatinib in combination with
rituximab.
- Appointed 20-year industry veteran Rajiv Patni, M.D., as executive vice president
and chief medical officer, with responsibility for leading Clinical
Development, Clinical Operations, Medical Affairs, Regulatory
Affairs, Biometrics, Pharmacovigilance and Project Management.
- Launched support of the American Heart
Association's® hospital-based quality improvement
initiative for enhanced awareness and understanding of best care
practices for hemorrhagic stroke.
Planned Upcoming Milestones
- Present and publish clinical, research and HEOR studies
supporting the adoption of Andexxa at medical meetings and in
peer-reviewed journals throughout the year, starting with the
presentation of three abstracts at the American College of
Cardiology 2020 Annual Meeting in March.
- Secure reimbursement coverage in the United Kingdom (mid-June 2020), Germany (2H 2020) and other Wave 1 European
countries.
- Continue launch of Ondexxya into Wave 2 countries in
Europe, which include the
additional EU5 countries of France, Spain, and Italy.
Conference Call Details
Portola will host a conference
call today, Wednesday, February 26,
2020, at 4:30 p.m. ET, during
which time management will discuss the fourth quarter and full-year
2019 financial results, updates on the U.S. and European launches
of Andexxa/Ondexxya, and its operations. The live call 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 6192918. 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.
Use of Non-GAAP Financial Measures
This press release and the reconciliation table included herein
include non-GAAP R&D expenses. The Company believes the
presentation of non-GAAP financial measures provides useful
information to management and investors regarding the company's
financial condition and results of operations. When viewed in
conjunction with GAAP financial measures, investors are provided
with a more meaningful understanding of the Company's ongoing
operating performance and are better able to compare the Company's
performance between periods. In addition, these non-GAAP financial
measures are among those that the Company uses as a basis for
evaluating performance, allocating resources and planning and
forecasting future periods. Non-GAAP financial measures are not
intended to be considered in isolation or as a substitute for GAAP
financial measures. A reconciliation of GAAP to non-GAAP financial
measures is provided in the accompanying table entitled
"Reconciliation of GAAP to Non-GAAP Financial Information."
Unaudited
Condensed Consolidated Statements of Operations
(In thousands,
except share and per share data)
|
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months
Ended December 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
|
28,375
|
|
|
$
|
14,070
|
|
|
$
|
111,644
|
|
|
$
|
24,117
|
|
Collaboration and
license revenue
|
|
873
|
|
|
1,228
|
|
|
4,996
|
|
|
16,013
|
|
Total
revenues
|
|
29,248
|
|
|
15,298
|
|
|
116,640
|
|
|
40,130
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
29,553
|
|
|
12,401
|
|
|
44,378
|
|
|
18,081
|
|
Research and
development
|
|
29,858
|
|
|
49,461
|
|
|
124,627
|
|
|
216,205
|
|
Selling, general and
administrative
|
|
59,980
|
|
|
40,617
|
|
|
218,919
|
|
|
151,164
|
|
Total operating
expenses
|
|
119,391
|
|
|
102,479
|
|
|
387,924
|
|
|
385,450
|
|
Loss from
operations
|
|
(90,143)
|
|
|
(87,181)
|
|
|
(271,284)
|
|
|
(345,320)
|
|
Interest and other
income, net
|
|
1,740
|
|
|
4,393
|
|
|
9,698
|
|
|
13,516
|
|
Interest
expense
|
|
(8,273)
|
|
|
(6,098)
|
|
|
(31,290)
|
|
|
(18,740)
|
|
Net loss
|
|
(96,676)
|
|
|
(88,886)
|
|
|
(292,876)
|
|
|
(350,544)
|
|
Net loss attributable
to noncontrolling interest
|
|
—
|
|
|
338
|
|
|
2,213
|
|
|
321
|
|
Net loss attributable
to Portola
|
|
$
|
(96,676)
|
|
|
$
|
(88,548)
|
|
|
$
|
(290,663)
|
|
|
$
|
(350,223)
|
|
Net loss per share
attributable to Portola common stockholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(1.24)
|
|
|
$
|
(1.34)
|
|
|
$
|
(4.06)
|
|
|
$
|
(5.31)
|
|
Shares used to
compute net loss per share attributable to Portola common
stockholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
77,870,113
|
|
|
66,497,034
|
|
|
71,555,220
|
|
|
66,017,330
|
|
Unaudited
Condensed Consolidated Balance Sheet Data
(In
thousands)
|
|
|
|
December 31,
2019
|
|
December 31,
2018
|
|
|
(Unaudited)
|
Cash, cash
equivalents and investments
|
|
$
|
466,244
|
|
|
$
|
316,964
|
|
Trade and other
receivables, net
|
|
13,547
|
|
|
5,849
|
|
Unbilled -
collaboration and license revenue
|
|
3,783
|
|
|
9,880
|
|
Inventories
|
|
4,101
|
|
|
7,873
|
|
Property and
equipment, net
|
|
4,264
|
|
|
5,236
|
|
Intangible
assets
|
|
—
|
|
|
7,279
|
|
Other
assets
|
|
86,543
|
|
|
33,338
|
|
Total
assets
|
|
578,483
|
|
|
386,419
|
|
Total current
liabilities
|
|
102,418
|
|
|
69,005
|
|
Long-term
liabilities
|
|
346,240
|
|
|
226,847
|
|
Total stockholders'
equity
|
|
129,825
|
|
|
90,567
|
|
Total liabilities and
stockholders' equity
|
|
578,483
|
|
|
386,419
|
|
PORTOLA
PHARMACEUTICALS, INC.
Reconciliation of
GAAP to Non-GAAP Financial Information
(In thousands,
except for per share data)
|
|
|
|
Three Months Ended December
31,
|
|
Twelve Months Ended December
31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Reconciliation of
cost of sales:
|
|
|
|
|
|
|
|
|
GAAP cost of
sales
|
|
$
|
29,553
|
|
|
$
|
12,401
|
|
|
$
|
44,378
|
|
|
$
|
18,081
|
|
Gen1
transition
|
|
—
|
|
|
(10,311)
|
|
|
(3,949)
|
|
|
(10,311)
|
|
Bevyxxa
impairment
|
|
(27,451)
|
|
|
—
|
|
|
(27,451)
|
|
|
—
|
|
Non-GAAP cost of
sales
|
|
$
|
2,102
|
|
|
$
|
2,090
|
|
|
$
|
12,978
|
|
|
$
|
7,770
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
research and development:
|
|
|
|
|
|
|
|
|
GAAP research and
development
|
|
$
|
29,858
|
|
|
$
|
49,461
|
|
|
$
|
124,627
|
|
|
$
|
216,205
|
|
Stock-based
compensation expense
|
|
(1,903)
|
|
|
(13,543)
|
|
|
(19,340)
|
|
|
(27,694)
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
(3,151)
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
(9,201)
|
|
|
(5,824)
|
|
|
(9,201)
|
|
Non-GAAP research and
development expenses
|
|
$
|
27,955
|
|
|
$
|
26,717
|
|
|
$
|
96,312
|
|
|
$
|
179,310
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
|
GAAP selling, general
and administrative expenses
|
|
$
|
59,980
|
|
|
$
|
40,617
|
|
|
$
|
218,919
|
|
|
$
|
151,164
|
|
Stock-based
compensation expense
|
|
(8,979)
|
|
|
(7,276)
|
|
|
(32,735)
|
|
|
(28,712)
|
|
Non-GAAP selling,
general and administrative expenses
|
|
$
|
51,001
|
|
|
$
|
33,341
|
|
|
$
|
186,184
|
|
|
$
|
122,452
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
total operating expenses:
|
|
|
|
|
|
|
|
|
GAAP total operating
expenses
|
|
$
|
119,391
|
|
|
$
|
102,479
|
|
|
$
|
387,924
|
|
|
$
|
385,450
|
|
Gen1
transition
|
|
—
|
|
|
(10,311)
|
|
|
(3,949)
|
|
|
(10,311)
|
|
Bevyxxa
impairment
|
|
(27,451)
|
|
|
—
|
|
|
(27,451)
|
|
|
—
|
|
Stock-based
compensation expense
|
|
(10,882)
|
|
|
(20,819)
|
|
|
(52,075)
|
|
|
(56,406)
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
(3,151)
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
(9,201)
|
|
|
(5,824)
|
|
|
(9,201)
|
|
Non-GAAP total
operating expenses
|
|
$
|
81,058
|
|
|
$
|
62,148
|
|
|
$
|
295,474
|
|
|
$
|
309,532
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
net loss attributable to Portola:
|
|
|
|
|
|
|
|
|
GAAP net loss
attributable to Portola shareholders
|
|
$
|
(96,676)
|
|
|
$
|
(88,548)
|
|
|
$
|
(290,663)
|
|
|
$
|
(350,223)
|
|
Gen1
transition
|
|
—
|
|
|
10,311
|
|
|
3,949
|
|
|
10,311
|
|
Bevyxxa
impairment
|
|
27,451
|
|
|
—
|
|
|
27,451
|
|
|
—
|
|
Stock-based
compensation expense
|
|
10,882
|
|
|
20,819
|
|
|
52,075
|
|
|
56,406
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
3,151
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
9,201
|
|
|
5,824
|
|
|
9,201
|
|
Non-GAAP net loss
attributable to Portola shareholders
|
|
$
|
(58,343)
|
|
|
$
|
(48,217)
|
|
|
$
|
(198,213)
|
|
|
$
|
(274,305)
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
diluted net loss per share:
|
|
|
|
|
|
|
|
|
GAAP net loss per
share
|
|
$
|
(1.24)
|
|
|
$
|
(1.34)
|
|
|
$
|
(4.06)
|
|
|
$
|
(5.31)
|
|
Gen1
transition
|
|
—
|
|
|
0.16
|
|
|
0.06
|
|
|
0.16
|
|
Bevyxxa
impairment
|
|
0.35
|
|
|
—
|
|
|
0.38
|
|
|
—
|
|
Stock-based
compensation expense
|
|
0.14
|
|
|
0.31
|
|
|
0.73
|
|
|
0.85
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
0.04
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
0.14
|
|
|
0.08
|
|
|
0.14
|
|
Non-GAAP net loss per
share
|
|
$
|
(0.75)
|
|
|
$
|
(0.73)
|
|
|
$
|
(2.77)
|
|
|
$
|
(4.16)
|
|
|
|
|
|
|
|
|
|
|
Shares used to
compute loss per share
|
|
77,870,113
|
|
|
66,497,034
|
|
|
71,555,220
|
|
|
66,017,330
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
adjustment summary:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
$
|
(27,451)
|
|
|
$
|
(10,311)
|
|
|
$
|
(31,400)
|
|
|
$
|
(10,311)
|
|
Research and
development
|
|
(1,903)
|
|
|
(22,744)
|
|
|
(28,315)
|
|
|
(36,895)
|
|
Selling, general and
administrative expenses
|
|
(8,979)
|
|
|
(7,276)
|
|
|
(32,735)
|
|
|
(28,712)
|
|
Total non-GAAP
adjustments
|
|
$
|
(38,333)
|
|
|
$
|
(40,331)
|
|
|
$
|
(92,450)
|
|
|
$
|
(75,918)
|
|
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a global, 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 conditions.
The Company's first two commercialized products are
Andexxa [coagulation factor Xa (recombinant),
inactivated-zhzo], marketed in Europe as
Ondexxya (andexanet alfa), and Bevyxxa (betrixaban). The
company also is advancing cerdulatinib, a SYK/JAK inhibitor being
developed for the treatment of hematologic cancers. Founded in 2003
in South San Francisco, California, Portola has
operations in the United States and Europe.
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, statements regarding
our Andexxa program, including our intention to present new
clinical data enhanced education and support related to
reimbursement, the initiation of our urgent surgery study, and
continued execution of the Ondexxya launch in Europe; statements regarding our expected
financial performance, including our 2020 financial guidance, and
other objectives described under the caption "Planned and Upcoming
Milestones." 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
for the indications which it is approved; we do not receive
favorable pricing reimbursement in the United Kingdom and Germany and other EU countries; 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; our clinical
trials may take longer and be more costly than anticipated; our
ability to grow our commercial operations in the EU and generate
product revenue within projected timelines and budget; the risk
that we 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 annual report on Form 10-K and 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/portola-pharmaceuticals-reports-fourth-quarter-and-full-year-2019-financial-results-and-provides-corporate-update-301012033.html
SOURCE Portola Pharmaceuticals, Inc.®