SOUTH SAN FRANCISCO, Calif.,
Aug. 7, 2019 /PRNewswire/ -- Portola
Pharmaceuticals, Inc.® (Nasdaq: PTLA) today
reported financial results for the three months ended June 30, 2019, and provided a corporate
update.
"This is our fifth consecutive quarter of strong revenue growth
reflecting our exceptional launch execution and continued demand
for Andexxa. Support for this novel therapy continues to grow with
CMS' decision to increase our NTAP reimbursement and two recent
updates from the Joint Commission which recommend specific reversal
agents for Factor Xa inhibitors. In Europe, the team exceeded
expectations on timing for the first sale of Ondexxya, and we are
positioned well to continue our launch in key European countries,"
said Scott Garland, Portola's president and chief executive
officer. "We look forward to building upon our momentum backed by a
rapidly growing Factor Xa inhibitor market and increasing global
demand for Andexxa. Beyond Andexxa, we plan to initiate a
registrational trial for cerdulatinib."
Quarter Ending June 30,
2019
- Total revenues for the second quarter of 2019 were $28.4 million, compared with $4.0 million for the second quarter of 2018. This
includes $27.1 million in net product
revenues from sales of Andexxa [coagulation factor Xa
(recombinant), inactivated-zhzo], $74
thousand in revenues from Bevyxxa® (betrixaban) sales and
$1.3 million in collaboration and
license revenues.
- Net loss attributable to Portola, according to generally accepted
accounting principles in the U.S. (GAAP), was $66.2 million, or $0.97 net loss per share for the second quarter
of 2019, compared with a net loss of $106.2
million, or $1.61 net loss per
share, for the same period in 2018. This includes the effect of a
$3.1 million impairment charge taken
in the second quarter related to the discontinuation of our SRX
program.
- Cash, cash equivalents and investments at June 30, 2019, totaled $273.9 million, compared with $317.0 million as of December 31, 2018.
- Total GAAP operating expenses for the second quarter of 2019
were $92.4 million, compared with
$107.7 million for the same period in
2018. This decrease was driven primarily by manufacturing costs for
Andexxa Gen 2 being capitalized and no longer flowing through
R&D.
- Stock-based compensation expense for the second quarter of 2019
was $12.3 million, compared with
$13.2 million for the same period in
2018.
- Cost of Sales (COS) for the second quarter of 2019 was
$5.0 million, compared to
$1.1 million for the same period in
2018. The increase was driven by the launch of Andexxa.
- Research and development (R&D) expenses were $33.5 million for the second quarter of 2019,
which includes the impairment charge, compared with $66.4 million for the second quarter of 2018. The
decrease was driven primarily by the manufacturing costs for
Andexxa Gen 2 being capitalized and no longer flowing through
R&D and partially offset by the SRX program impairment
charge.
- Non-GAAP research and development expenses, which excludes the
SRX program impairment charge, were $30.4
million for the second quarter of 2019. Please see the
reconciliation of GAAP to non-GAAP financial measures table at the
end of this release for more details.
- Selling, general and administrative (SG&A) expenses for the
second quarter of 2019 were $53.9
million, compared with $40.2
million for the same period in 2018. The increase was driven
by the expansion of the Company's field force, commercial
activities to support the launch of Andexxa and launch preparations
in Europe.
Recent Achievements and Events
- Launched Ondexxya with first orders in Europe.
- CMS increased maximum NTAP reimbursement for Andexxa from 50 to
65 percent effective on October 1,
2019.
- Presented new Andexxa data from a subset of patients from the
ANNEXA-4 study with spontaneous (non-traumatic) intracranial
hemorrhage, which demonstrated excellent or good hemostasis
achieved in 79% of evaluable patients.
- Presented in vitro data 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.
- Presented new interim results from the cerdulatinib Phase 2a
study demonstrating favorable safety and efficacy profiles in
patients with relapsed/refractory follicular lymphoma (FL)
receiving cerdulatinib alone (45% objective response rate) or in
combination with rituximab (62% objective response rate).
Planned Upcoming Milestones
- Continue launch of Ondexxya in a select group of high-potential
European countries where Factor Xa inhibitor use is among the
highest.
- Plan to initiate surgical study for Andexxa label expansion by
year end or beginning of 2020.
- Launch a cerdulatinib registrational study in peripheral T-cell
lymphoma (PTCL) by the end of the year.
- Present new data from additional subsets of the ANNEXA-4
study.
Conference Call Details
Portola will host a conference call today,
Wednesday, August 7, 2019, at
4:30 p.m. ET, during which time
management will discuss the second quarter 2019 financial results,
updates on the U.S. launch of Andexxa, and other matters. 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 8046269. 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
27,164
|
|
$
2,265
|
|
$
47,526
|
|
$
2,871
|
Collaboration and
license revenue
|
|
1,260
|
|
1,746
|
|
3,067
|
|
7,784
|
Total
revenues
|
|
28,424
|
|
4,011
|
|
50,593
|
|
10,655
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
Sales
|
|
4,991
|
|
1,052
|
|
12,141
|
|
1,388
|
Research and
development
|
|
33,538
|
|
66,440
|
|
69,122
|
|
126,507
|
Selling, general and
administrative
|
|
53,855
|
|
40,214
|
|
106,889
|
|
71,755
|
Total operating
expenses
|
|
92,384
|
|
107,706
|
|
188,152
|
|
199,650
|
Loss from
operations
|
|
(63,960)
|
|
(103,695)
|
|
(137,559)
|
|
(188,995)
|
Interest and other
income, net
|
|
4,021
|
|
1,828
|
|
6,005
|
|
5,199
|
Interest
expense
|
|
(8,538)
|
|
(4,104)
|
|
(15,019)
|
|
(6,685)
|
Net loss
|
|
(68,477)
|
|
(105,971)
|
|
(146,573)
|
|
(190,481)
|
Net (income) loss
attributable to noncontrolling interest
|
|
2,273
|
|
(223)
|
|
2,213
|
|
109
|
Net loss attributable
to Portola
|
|
$
(66,204)
|
|
$
(106,194)
|
|
$
(144,360)
|
|
$
(190,372)
|
Net loss per share
attributable to Portola common stockholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
(0.97)
|
|
$
(1.61)
|
|
$
(2.14)
|
|
$
(2.90)
|
Shares used to
compute net loss per share attributable to Portola common
stockholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
68,128,238
|
|
65,884,767
|
|
67,602,126
|
|
65,698,391
|
Unaudited
Condensed Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
June 30,
2019
|
December 31,
2018
|
|
|
(Unaudited)
|
Cash, cash
equivalents and investments
|
|
$ 273,938
|
|
$ 316,964
|
Trade and other
receivables, net
|
|
13,955
|
|
5,849
|
Unbilled -
collaboration and license revenue
|
|
4,795
|
|
9,880
|
Inventories
|
|
1,547
|
|
7,873
|
Property and
equipment, net
|
|
4,769
|
|
5,236
|
Intangible
assets
|
|
3,844
|
|
7,279
|
Other
assets
|
|
63,649
|
|
33,338
|
Total
assets
|
|
366,497
|
|
386,419
|
Current
liabilities
|
|
84,307
|
|
69,005
|
Long-term
liabilities
|
|
281,596
|
|
226,847
|
Total stockholders'
equity
|
|
594
|
|
90,567
|
Total liabilities and
stockholders' equity
|
|
366,497
|
|
386,419
|
PORTOLA
PHARMACEUTICALS, INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
(In
thousands)
|
|
|
|
|
|
Three Months
Ended
June 30, 2019
|
Reconciliation of
research and development:
|
|
|
GAAP Research and
development
|
|
33,538
|
SRX intangible
impairment
|
|
(3,151)
|
Non-GAAP research and
development expenses
|
|
$
30,387
|
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, potential label expansion
opportunities for 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
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.
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SOURCE Portola Pharmaceuticals, Inc.