SOUTH SAN FRANCISCO, Calif.,
Nov. 5, 2019 /PRNewswire/
-- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA)
today reported financial results for the three months ended
September 30, 2019, and provided a corporate update.
"We delivered another quarter of strong Andexxa revenue in the
U.S. and expanded our growth potential with our first sales of
Ondexxya in Europe. The use of
Factor Xa inhibitors in both markets continues to grow, driving the
underlying market opportunity for Andexxa/Ondexxya and long-term
value of Portola," said
Scott Garland, Portola's president and chief executive
officer. "Looking forward, we will continue to focus on exceptional
launch execution, leveraging external support from health
authorities and favorable society guidelines, and building the
clinical evidence and awareness of Andexxa. In addition, we remain
on track to initiate a registration trial for cerdulatinib in early
2020 and will present updated data at the ASH meeting in
December."
Product Sales:
- Total global revenues for the third quarter of 2019 were
$36.8 million compared with
$14.2 million for the third quarter
of 2018. This includes $35.7 million
in net product revenues from sales of Andexxa/Ondexxya [coagulation
factor Xa (recombinant), inactivated-zhzo], $17,000 in revenues from Bevyxxa®
(betrixaban) sales and $1.1 million
in collaboration and license revenues.
- Net loss attributable to Portola, according to generally accepted
accounting principles in the U.S. (GAAP) was $49.6 million, or $0.68 net loss per share for the third quarter of
2019, compared with a net loss of $71.3
million, or $1.08 net loss per
share, for the same period in 2018.
Operating Expenses:
For the third quarter of 2019, compared to the same period in
2018:
- Research and development (R&D) expenses decreased by
$14.6 million, or 36.3%, 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
increased by $13.3 million, or 34.2%,
due to commercial costs to support the Andexxa launch including the
expansion of the field sales teams and launch preparations in
Europe.
- Cost of Sales (COS) were $2.7
million for the third quarter of 2019, compared to
$4.3 million for the same period in
2018. This decrease was primarily due to transition from our Gen 1
to our Gen 2 Andexxa product.
- These amounts on a GAAP and non-GAAP basis are reflected in the
table below. A table reflecting the reconciliation of GAAP to
non-GAAP amounts is included at the end of this release.
|
|
Three Months Ended September
30,
|
|
Nine Months Ended September
30,
|
(In
thousands)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Cost of
Sales
|
|
$
|
2,684
|
|
|
$
|
4,292
|
|
|
$
|
14,825
|
|
|
$
|
5,680
|
|
Non-GAAP cost of
sales
|
|
$
|
2,684
|
|
|
$
|
4,292
|
|
|
$
|
10,876
|
|
|
$
|
5,680
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
$
|
25,647
|
|
|
$
|
40,237
|
|
|
$
|
94,769
|
|
|
$
|
166,744
|
|
Non-GAAP research and
development expenses
|
|
$
|
21,916
|
|
|
$
|
35,858
|
|
|
$
|
68,358
|
|
|
$
|
152,593
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses
|
|
$
|
52,050
|
|
|
$
|
38,792
|
|
|
$
|
158,939
|
|
|
$
|
110,547
|
|
Non-GAAP selling,
general and administrative expenses
|
|
$
|
44,735
|
|
|
$
|
31,778
|
|
|
$
|
135,183
|
|
|
$
|
89,111
|
|
|
|
|
|
|
|
|
|
|
Totaling operating
expenses
|
|
$
|
80,381
|
|
|
$
|
83,321
|
|
|
$
|
268,533
|
|
|
$
|
282,971
|
|
Non-GAAP Total
operating expenses
|
|
$
|
69,335
|
|
|
$
|
71,928
|
|
|
$
|
214,416
|
|
|
$
|
247,384
|
|
Cash, Cash Equivalents and Investments:
- Cash, cash equivalents and investments at September 30, 2019, totaled $476.8 million, compared with $317.0 million as of December 31, 2018. During the third quarter, the
Company added net proceeds of $245
million in connection with the follow on offering of the
Company's common stock.
Recent Achievements and Events
- Ondexxya launched with $2.7
million of European net sales in the third quarter of
2019.
- Andexxa added to the Veteran's Health Administration national
formulary, making access to 170 VA hospitals across the U.S.
possible.
- Andexxa recommended as first line therapy by The American
Academy of Family Physicians (AAFP).
- Centers for Medicare and Medicaid Services (CMS) New Technology
Add-on Payment (NTAP) reimbursement for Andexxa increased from 50%
to 65% effective on October 1,
2019.
- Presented sub-analysis of ANNEXA-4 study at the American
College of Gastroenterology annual meeting, highlighting the
efficacy and safety of Andexxa in Factor Xa patients with acute
gastrointestinal bleeding, which demonstrated excellent or good
hemostasis achieved in 82% of evaluable patients.
- Presented in vitro data at International Society of Thrombosis
and Hemostasis annual meeting, demonstrating that four-factor
prothrombin complex concentrate (4F-PCC) does not appear to have an
effect on the inhibition of thrombin generation by apixaban or
rivaroxaban unless the Factor Xa inhibitor concentration was less
than 75 ng/mL. In contrast, data from the same thrombin generation
assay demonstrated that Andexxa fully corrected the inhibition of
thrombin generation by apixaban and rivaroxaban across a broad
range of inhibitor concentrations.
- Net proceeds of $245 million
raised in a public offering of the Company's common stock.
Planned Upcoming Milestones
- Continue launch of Ondexxya in a select group of high-potential
European countries with significant usage of Factor Xa inhibitors
and supportive access and reimbursement.
- Plan to initiate an urgent surgery study for Andexxa by year
end or in early 2020.
- Plan to launch a cerdulatinib registration study in peripheral
T-cell lymphoma (PTCL) in early 2020.
- Multiple abstracts related to Andexxa and cerdulatinib accepted
for presentation at the American Society of Hematology annual
meeting in December.
Analyst and Investor Meeting
Portola will host an analyst
and investor meeting focused on Andexxa on Thursday, November 14, 2019, from 8:00 to 10:30 a.m. ET in New York. Seating is limited to those who
RSVP. Please contact events@portola.com for an invitation. The
event will also be webcast live and can be accessed live on the
Investor Relations section of the Company's website at
http://investors.portola.com. It will be archived for one year
following the date of the event.
Conference Call Details
Portola will host a conference
call today, Tuesday, November 5,
2019, at 4:30 p.m. ET, during
which time management will discuss the third quarter 2019 financial
results, updates on the U.S. and European launch 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 2980632. 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."
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
the anticipated initiation of a registrational trial for
cerdulatinib in PTCL, the growing demand for our products, our
continued commercial launch for Ondexxya in Europe, our ability to leverage external
support from health authorities and build clinical evidence and
awareness of Andexxa and our plans to present new data and continue
development of our products and product candidates. 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
for which it is approved; 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 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 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,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
|
35,743
|
|
|
$
|
7,176
|
|
|
$
|
83,269
|
|
|
$
|
10,047
|
|
Collaboration and
license revenue
|
|
1,056
|
|
|
7,001
|
|
|
4,123
|
|
|
14,785
|
|
Total
revenues
|
|
36,799
|
|
|
14,177
|
|
|
87,392
|
|
|
24,832
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
2,684
|
|
|
4,292
|
|
|
14,825
|
|
|
5,680
|
|
Research and
development
|
|
25,647
|
|
|
40,237
|
|
|
94,769
|
|
|
166,744
|
|
Selling, general and
administrative
|
|
52,050
|
|
|
38,792
|
|
|
158,939
|
|
|
110,547
|
|
Total operating
expenses
|
|
80,381
|
|
|
83,321
|
|
|
268,533
|
|
|
282,971
|
|
Loss from
operations
|
|
(43,582)
|
|
|
(69,144)
|
|
|
(181,141)
|
|
|
(258,139)
|
|
Interest and other
income, net
|
|
1,953
|
|
|
3,924
|
|
|
7,958
|
|
|
9,123
|
|
Interest
expense
|
|
(7,998)
|
|
|
(5,957)
|
|
|
(23,017)
|
|
|
(12,642)
|
|
Net loss
|
|
(49,627)
|
|
|
(71,177)
|
|
|
(196,200)
|
|
|
(261,658)
|
|
Net (income) loss
attributable to noncontrolling interest
|
|
—
|
|
|
(126)
|
|
|
2,213
|
|
|
(17)
|
|
Net loss attributable
to Portola
|
|
$
|
(49,627)
|
|
|
$
|
(71,303)
|
|
|
$
|
(193,987)
|
|
|
$
|
(261,675)
|
|
Net loss per share
attributable to Portola common stockholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.68)
|
|
|
$
|
(1.08)
|
|
|
$
|
(2.79)
|
|
|
$
|
(3.97)
|
|
Shares used to
compute net loss per share attributable to Portola common
stockholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
73,017,609
|
|
|
66,165,104
|
|
|
69,427,124
|
|
|
65,855,672
|
|
Unaudited
Condensed Consolidated Balance Sheet Data
|
|
(In
thousands)
|
|
|
|
September 30,
2019
|
|
December 31,
2018
|
|
|
(Unaudited)
|
Cash, cash
equivalents and investments
|
|
$
|
476,807
|
|
|
$
|
316,964
|
|
Trade and other
receivables, net
|
|
18,236
|
|
|
5,849
|
|
Unbilled -
collaboration and license revenue
|
|
3,788
|
|
|
9,880
|
|
Inventories
|
|
2,357
|
|
|
7,873
|
|
Property and
equipment, net
|
|
4,561
|
|
|
5,236
|
|
Intangible
assets
|
|
3,699
|
|
|
7,279
|
|
Other
assets
|
|
67,737
|
|
|
33,338
|
|
Total
assets
|
|
577,185
|
|
|
386,419
|
|
Total current
liabilities
|
|
87,491
|
|
|
69,005
|
|
Long-term
liabilities
|
|
276,806
|
|
|
226,847
|
|
Total stockholders'
equity
|
|
212,888
|
|
|
90,567
|
|
Total liabilities and
stockholders' equity
|
|
577,185
|
|
|
386,419
|
|
PORTOLA
PHARMACEUTICALS, INC.
|
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
|
(In thousands,
except for per share data)
|
|
|
|
Three Months Ended September
30,
|
|
Nine Months Ended September
30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Reconciliation of
cost of sales:
|
|
|
|
|
|
|
|
|
GAAP cost of
sales
|
|
$
|
2,684
|
|
|
$
|
4,292
|
|
|
$
|
14,825
|
|
|
$
|
5,680
|
|
Gen1
transition
|
|
—
|
|
|
—
|
|
|
(3,949)
|
|
|
—
|
|
Non-GAAP cost of
sales
|
|
$
|
2,684
|
|
|
$
|
4,292
|
|
|
$
|
10,876
|
|
|
$
|
5,680
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
research and development:
|
|
|
|
|
|
|
|
|
GAAP research and
development
|
|
$
|
25,647
|
|
|
$
|
40,237
|
|
|
$
|
94,769
|
|
|
$
|
166,744
|
|
Stock-based
compensation expense
|
|
(3,731)
|
|
|
(4,379)
|
|
|
(17,437)
|
|
|
(14,151)
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
(3,151)
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
—
|
|
|
(5,824)
|
|
|
—
|
|
Non-GAAP research and
development expenses
|
|
$
|
21,916
|
|
|
$
|
35,858
|
|
|
$
|
68,358
|
|
|
$
|
152,593
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
selling, general and administrative expenses:
|
|
|
|
|
|
|
|
|
GAAP selling, general
and administrative expenses
|
|
$
|
52,050
|
|
|
$
|
38,792
|
|
|
$
|
158,939
|
|
|
$
|
110,547
|
|
Stock-based
compensation expense
|
|
(7,315)
|
|
|
(7,014)
|
|
|
(23,756)
|
|
|
(21,436)
|
|
Non-GAAP selling,
general and administrative expenses
|
|
$
|
44,735
|
|
|
$
|
31,778
|
|
|
$
|
135,183
|
|
|
$
|
89,111
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
total operating expenses:
|
|
|
|
|
|
|
|
|
GAAP total operating
expenses
|
|
$
|
80,381
|
|
|
$
|
83,321
|
|
|
$
|
268,533
|
|
|
$
|
282,971
|
|
Gen1
transition
|
|
—
|
|
|
—
|
|
|
(3,949)
|
|
|
—
|
|
Stock-based
compensation expense
|
|
(11,046)
|
|
|
(11,393)
|
|
|
(41,193)
|
|
|
(35,587)
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
(3,151)
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
—
|
|
|
(5,824)
|
|
|
—
|
|
Non-GAAP total
operating expenses
|
|
$
|
69,335
|
|
|
$
|
71,928
|
|
|
$
|
214,416
|
|
|
$
|
247,384
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
net loss attributable to Portola:
|
|
|
|
|
|
|
|
|
GAAP net loss
attributable to Portola shareholders
|
|
$
|
(49,627)
|
|
|
$
|
(71,303)
|
|
|
$
|
(193,987)
|
|
|
$
|
(261,675)
|
|
Gen1
transition
|
|
—
|
|
|
—
|
|
|
3,949
|
|
|
—
|
|
Stock-based
compensation expense
|
|
11,046
|
|
|
11,393
|
|
|
41,193
|
|
|
35,587
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
3,151
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
—
|
|
|
5,824
|
|
|
—
|
|
Non-GAAP net loss
attributable to Portola shareholders
|
|
$
|
(38,581)
|
|
|
$
|
(59,910)
|
|
|
$
|
(139,870)
|
|
|
$
|
(226,088)
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
diluted net loss per share:
|
|
|
|
|
|
|
|
|
GAAP net loss per
share
|
|
$
|
(0.68)
|
|
|
$
|
(1.08)
|
|
|
$
|
(2.79)
|
|
|
$
|
(3.97)
|
|
Gen1
transition
|
|
—
|
|
|
—
|
|
|
0.06
|
|
|
—
|
|
Stock-based
compensation expense
|
|
0.15
|
|
|
0.17
|
|
|
0.59
|
|
|
0.54
|
|
SRX intangible
impairment
|
|
—
|
|
|
—
|
|
|
0.05
|
|
|
—
|
|
Equity valuation to
manufacturer
|
|
—
|
|
|
—
|
|
|
0.08
|
|
|
—
|
|
Non-GAAP net loss per
share
|
|
$
|
(0.53)
|
|
|
$
|
(0.91)
|
|
|
$
|
(2.01)
|
|
|
$
|
(3.43)
|
|
|
|
|
|
|
|
|
|
|
Shares used to
compute loss per share
|
|
73,018
|
|
|
66,165
|
|
|
69,427
|
|
|
65,856
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
adjustment summary:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(3,949)
|
|
|
$
|
—
|
|
Research and
development
|
|
(3,731)
|
|
|
(4,379)
|
|
|
(26,412)
|
|
|
(14,151)
|
|
Selling, general and
administrative expenses
|
|
(7,315)
|
|
|
(7,014)
|
|
|
(23,756)
|
|
|
(21,436)
|
|
Total non-GAAP
adjustments
|
|
$
|
(11,046)
|
|
|
$
|
(11,393)
|
|
|
$
|
(54,117)
|
|
|
$
|
(35,587)
|
|
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SOURCE Portola Pharmaceuticals, Inc.®