Portola Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Corporate Update
May 08 2019 - 8:01AM
Portola Pharmaceuticals, Inc. ® (Nasdaq: PTLA) today reported
financial results for the three months ended March 31, 2019 and
provided a corporate update.
“Our first quarter results continue to reflect
strong demand for Andexxa, as well as focused execution on our
commercial launch. The full commercial U.S. launch of Andexxa is
off to a great start, and with approval of Ondexxya in Europe, we
now have another long-term growth catalyst and the ability to
impact thousands of additional patient lives,” said Scott Garland,
Portola’s president and chief executive officer. “Additionally, we
continue to make progress with cerdulatinib and look forward to
further defining its safety and efficacy profile, along with
that of Andexxa, in a number of scientific presentations
anticipated in Q2.”
Quarter Ending March 31,
2019
- Total revenues for the first
quarter of 2019 were $22.2 million, compared with $6.6
million for the first quarter of 2018. This
includes $20.3 million in net product revenues from
Andexxa sales, $77 thousand in revenues from Bevyxxa®
sales and $1.8 million in collaboration and license
revenues. Please see the tables at the end of this press release
for a detailed breakdown of revenues.
- Net loss attributable to Portola,
according to generally accepted accounting principles in the U.S.
(GAAP), was $78.2 million for the first quarter of 2019,
or $1.17 net loss per share, compared with a net loss
of $84.2 million, or $1.28 net loss per share, for
the same period in 2018. This includes the effect of two charges
taken in the first quarter related to the U.S. Food and Drug
Administration (FDA) approval of the Company’s Gen 2
manufacturing process. The first is a $5.8 million charge
associated with the valuation of the Company equity that will be
issued to Lonza, our Andexxa Gen 2 manufacturer (“manufacturing
site charge”), and the second is a $3.9 million charge associated
with the Andexxa Gen 1 product as hospitals transition to the Gen 2
product (“Gen 1 supply charge”).
- Non-GAAP net loss for the first
quarter of 2019 was $68.4 million, or a non-GAAP basic and diluted
loss per share of $1.02. Non-GAAP net loss and net loss per share
have been adjusted to remove the manufacturing site charge and the
Gen 1 supply charge. Please see the reconciliation of GAAP to
non-GAAP financial measures at the end of this release for more
details.
- Cash, cash equivalents and
investments at March 31, 2019 totaled $322.8
million, compared with $317.0 million as
of December 31, 2018. In March, the Company entered into a
$125 million loan agreement and received an initial tranche of
$62.5 million, with the balance available at Portola’s option in
the third quarter, subject to certain conditions, extending our
cash runway to the end of 2020.
- Total operating expenses for the
first quarter of 2019 were $95.8 million, compared
with $91.9 million for the same period in 2018. The
increase was driven by the timing of launch activities in the U.S.,
the build-out of the Company’s field force and launch preparations
in Europe.
- Non-GAAP total operating expenses,
which excludes the two charges outlined above, were $86.0 million
for the first quarter of 2019. Please see the reconciliation of
GAAP to non-GAAP financial measures table at the end of this
release for more details.
- Stock-based compensation expense
for the first quarter of 2019 was $17.9 million, compared
with $11.0 million for the same period in 2018. This
year-over-year increase was driven primarily by the equity issued
for the manufacturing site charge.
- Cost of Sales (COS) for the first
quarter of 2019 were $7.2 million, compared to $336
thousand for the same period in 2018. The increase was driven
by the launch of Andexxa and the Gen 1 supply charge.
- Research and development (R&D)
expenses were $35.6 million for the first quarter of
2019, compared with $60.1 million for the first 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.
- Selling, general and administrative
(SG&A) expenses for the first quarter of 2019 were $53.0
million, compared with $31.5 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
- Received European Commission approval of Ondexxya and hired
Head of Europe to build a team to support planned commercial
activity.
- Received C-code from The Centers for Medicare & Medicaid
Services, allowing hospitals an additional reimbursement pathway
for Andexxa.
- Submitted additional data to the FDA on the proposed dose
for cerdulatinib.
- Announced the retirements of Portola co-founder Charles Homcy,
M.D. from the Board of Directors, and John Curnutte, M.D., Ph.D.,
Executive Vice President of Research and Development.
Upcoming Milestones
- Staged launch of Ondexxya in a select group of high-potential
European countries where Factor Xa inhibitor use is among the
highest.
- Present new data on:
- The impact of Andexxa on patients with an intracranial
hemorrhage at the European Stroke Organization Conference in Milan
in May.
- The question of whether PCCs have clinical activity in the
reversal of direct FXa inhibitors at the International Society of
Thrombosis and Hematology meeting in Melbourne.
- The safety and efficacy of cerdulatinib in relapsed/refractory
follicular lymphoma, either alone or in combination with
rituximab.
- Initiate discussions with the FDA on a number of potential
label expansion opportunities including the addition of the
ANNEXA-4 efficacy data, the inclusion of edoxaban and enoxaparin,
and the potential initiation of a study in urgent surgery.
Conference Call DetailsPortola
will host a conference call today, Wednesday, May 8, 2019, at 8:30
a.m. ET, during which time management will discuss the first
quarter 2019 financial results, as well as updates on the U.S.
launch of Andexxa, launch preparations in Europe and other matters.
The live call can be accessed by phone by dialing (844) 452-6828
from the U.S. and Canada or 1 (765) 507-2588 internationally and
using the passcode 1684446. 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
MeasuresThis press release and the reconciliation table
included herein include non-GAAP net loss, non-GAAP basic and
diluted loss per share and non-GAAP operating 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 Measures."
|
|
|
Reconciliation of GAAP to Non-GAAP Financial
Measures |
|
|
|
|
Three Months Ended March 31, 2019 |
|
(In thousands, except per
share data) |
GAAPAmount |
Non-GAAPAdjustments |
Non-GAAPAmount |
|
Product revenue, net |
$ |
20,362 |
|
|
- |
|
$ |
20,362 |
|
|
Collaboration and license revenue |
|
1,807 |
|
|
- |
|
|
1,807 |
|
|
Total revenues |
|
22,169 |
|
|
- |
|
|
22,169 |
|
|
|
|
|
|
|
Cost of sales |
|
7,150 |
|
|
(3,949 |
) |
|
3,201 |
|
|
Research and development |
|
35,584 |
|
|
(5,824 |
) |
|
29,760 |
|
|
Selling, general and administrative |
|
53,034 |
|
|
- |
|
|
53,034 |
|
|
Total operating expenses |
|
95,768 |
|
|
(9,773 |
) |
|
85,995 |
|
|
|
|
|
|
|
Net loss attributable to Portola |
$ |
(78,156 |
) |
|
9,773 |
|
$ |
(68,383 |
) |
|
|
|
|
|
|
Net loss per share (basic/diluted) |
$ |
(1.17 |
) |
$ |
0.15 |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
Shares used to compute loss per share |
|
67,070,168 |
|
|
|
67,070,168 |
|
|
|
|
|
|
|
Notes: Non-GAAP
adjustments consist of: (1) A $5.8 million charge associated with
the valuation of the Company equity that was issued in 1Q'19 to
Lonza, our Andexxa Gen 2 manufacturer, and (2) a $3.9 million
charge associated with our Andexxa Gen 1 product as we transition
hospitals to Gen 2 product, following approval on December 31,
2018. |
|
Unaudited Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
data) |
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Revenues: |
|
|
|
|
Product revenue, net |
|
$ |
20,362 |
|
|
$ |
606 |
|
Collaboration and license revenue |
|
|
1,807 |
|
|
|
6,038 |
|
Total revenues |
|
|
22,169 |
|
|
|
6,644 |
|
Operating expenses: |
|
|
|
|
Cost of Sales |
|
|
7,150 |
|
|
|
336 |
|
Research and development |
|
|
35,584 |
|
|
|
60,067 |
|
Selling, general and administrative |
|
|
53,034 |
|
|
|
31,541 |
|
Total operating expenses |
|
|
95,768 |
|
|
|
91,944 |
|
Loss from operations |
|
|
(73,599 |
) |
|
|
(85,300 |
) |
Interest and other expense, net |
|
|
1,984 |
|
|
|
3,371 |
|
Interest expense |
|
|
(6,481 |
) |
|
|
(2,581 |
) |
Net loss |
|
|
(78,096 |
) |
|
|
(84,510 |
) |
Net (income) loss attributable to noncontrolling interest |
|
|
(60 |
) |
|
|
332 |
|
Net loss attributable to Portola |
|
$ |
(78,156 |
) |
|
$ |
(84,178 |
) |
Net loss per share attributable to Portola common
stockholders: |
|
|
|
|
Basic and diluted |
|
$ |
(1.17 |
) |
|
$ |
(1.28 |
) |
Shares used to compute net loss per share attributable to Portola
common stockholders: |
|
|
|
|
Basic and diluted |
|
|
67,070,168 |
|
|
|
65,509,945 |
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Balance Sheet
Data |
(In thousands) |
|
|
|
March 31, 2019 |
|
December 31, 2018 |
|
(Unaudited) |
Cash, cash equivalents and investments |
|
$ |
322,841 |
|
|
$ |
316,964 |
Trade and other receivables, net |
|
|
11,787 |
|
|
|
5,849 |
Unbilled - collaboration and license revenue |
|
|
6,317 |
|
|
|
9,880 |
Inventories |
|
|
2,672 |
|
|
|
7,873 |
Property and equipment, net |
|
|
5,032 |
|
|
|
5,236 |
Intangible assets |
|
|
7,137 |
|
|
|
7,279 |
Other assets |
|
|
44,596 |
|
|
|
33,338 |
Total assets |
|
$ |
400,382 |
|
|
$ |
386,419 |
Current liabilities |
|
$ |
73,828 |
|
|
$ |
69,005 |
Long-term liabilities |
|
|
275,904 |
|
|
|
226,847 |
Total stockholders’ equity |
|
|
50,650 |
|
|
|
90,567 |
Total liabilities and stockholders’ equity |
|
$ |
400,382 |
|
|
$ |
386,419 |
|
|
|
|
|
|
About Portola Pharmaceuticals,
Inc.Portola Pharmaceuticals is a 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 diseases.
The Company’s two FDA-approved medicines are Andexxa® [coagulation
factor Xa (recombinant), inactivated-zhzo], the first and only
antidote for patients treated with rivaroxaban or apixaban when
reversal of anticoagulation is needed due to life-threatening or
uncontrolled bleeding, and Bevyxxa® (betrixaban), the first and
only oral, once-daily Factor Xa inhibitor for the prevention of VTE
in adult patients hospitalized for an acute medical illness. The
company also is advancing cerdulatinib, a Syk/JAK inhibitor for the
treatment of hematologic cancers.
Forward-Looking StatementsStatements 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 launch timing,
strategy and revenues for Ondexxya in Europe and potential
treatment benefits of our products and product candidates; our
plans to present new data and continue development of our products
and product candidates; our expectation that our cash runway will
extend to the end of 2020. 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 establish commercial operations in the EU and generate
product revenue within projected timelines and budget; the risk
that Portola 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. 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.
Investor Contact:Cara MillerPortola
PharmaceuticalsIR@portola.com |
|
Media
Contact:Julie NormartPure
Communicationsjnormart@purecommunications.com |
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