Portola Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
March 01 2019 - 8:05AM
– Fourth Quarter Andexxa® Revenues of $14.0
Million; Third Consecutive Quarter of Strong
Revenues –
Portola Pharmaceuticals, Inc. ® (Nasdaq: PTLA) today reported
financial results for the three and twelve months ended December
31, 2018 and provided a corporate update.
“Today’s positive opinion on Ondexxya™ from the
Committee for Medicinal Products for Human Use (CHMP) builds
upon the momentum established in 2018, which included the U.S. Food
and Drug Administration (FDA) approval of our
breakthrough-designated, Factor Xa inhibitor reversal agent
Andexxa®, followed by three consecutive quarters of strong revenues
and the approval of our Generation 2 manufacturing process. We
also continued the build-out of our experienced leadership team and
advanced our Syk/JAK inhibitor cerdulatinib,” said Scott Garland,
Portola’s president and chief executive officer. “With the full
commercial launch of Andexxa now underway in the United States, the
pending approval from the European Commission anticipated in early
May, and the further extension of our cash runway, we look forward
to continuing our positive momentum through 2019.”
Quarter Ending Dec. 31, 2018 and Full
Year 2018 Financial Results
- Total revenues for the fourth
quarter of 2018 were $15.3 million, compared with $9.8
million for the fourth quarter of 2017. This
includes $14.0 million in net product revenues from
Andexxa sales, $35 thousand in revenues from Bevyxxa® sales
and $1.2 million in collaboration and license revenues.
Total revenues for the full year 2018 were $40.1 million, compared
with $22.5 million for the full year 2017. 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 $88.5 million for the fourth quarter of 2018,
or $1.34 net loss per share, compared with a net loss
of $91.8 million, or $1.41 net loss per share, for
the same period in 2017. Net loss for the full year 2018
was $350.2 million, or $5.31 net loss per share, compared
with a net loss of $286.1 million, or $4.81 net loss per
share, for the full year 2017. This includes the effect of two
charges taken in the fourth quarter of 2018 related to the FDA
approval for the Company’s Gen 2 manufacturing process. The first
is a $9.2 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
$10.3 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 fourth
quarter of 2018 was $69.0 million, or a non-GAAP basic and diluted
loss per share of $1.04. For the full year 2018, non-GAAP net loss
was $330.7 million, or non-GAAP basic and diluted loss per share of
$5.01. Non-GAAP net loss and 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 December 31, 2018 totaled $317.0
million, compared with $534.2 million as
of December 31, 2017.
- Total operating expenses for the
fourth quarter of 2018 were $102.5 million, compared
with $95.7 million for the same period in 2017. Total
operating expenses for the full year 2018 were $385.5 million,
compared with $295.2 million for the full year 2017. This
year-over-year increase was driven by the Company’s Gen 2
manufacturing expenses, the build-out of the Company’s field force,
as well as the two charges outlined above in the fourth
quarter.
- Non-GAAP total operating expenses,
which excludes the two charges outlined above, were $83.0 million
for the fourth quarter of 2018, and $365.9 million for the full
year 2018. 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 fourth quarter of 2018 was $19.8 million, compared
with $10.9 million for the same period in 2017.
Stock-based compensation expense for the full year 2018
was $55.4 million, compared with $43.3 million for
the full year 2017. This year-over-year increase was driven mainly
by the manufacturing site charge.
- Cost of Sales (COS) for the fourth
quarter of 2018 were $12.4 million, compared to $260 thousand for
the same period in 2017. COS for the full year 2018 were $18.1
million, compared to $415 thousand for the same period in 2017.
This year-over-year increase was driven by the launches of Andexxa
and Bevyxxa, and the Gen 1 supply charge.
- Research and development (R&D)
expenses were $49.5 million for the fourth quarter of
2018, compared with $68.5 million for the fourth quarter
of 2017. The decrease was driven primarily by the timing of
manufacturing costs for Andexxa Gen 2 campaigns. R&D expenses
were $216.2 million for the full year 2018, compared
with $203.7 million for the full year 2017. This
year-over-year increase was driven by expenses related to Andexxa
Gen 2 manufacturing.
- Selling, general and administrative
(SG&A) expenses for the fourth quarter of 2018 were $40.6
million, compared with $26.9 million for the same period
in 2017. SG&A expenses for the full year 2018 were $151.2
million, compared with $91.1 million for the full year
2017. These increases were driven by the hiring of the Company’s
field force to support the launches of Andexxa and Bevyxxa.
2019 Annual Financial
GuidanceFor the fiscal year 2019, Portola expects total
R&D expenses to be between $125 million and $140 million,
including stock-based compensation of approximately $22 million.
Portola expects total SG&A expenses to be between $200 million
and $215 million, including stock-based compensation expenses of
approximately $36 million. These operating expenses are primarily
for ongoing clinical trials, potential label enhancing studies for
Andexxa, and support for the commercial launch of Andexxa in the
U.S and launch activities in Europe.
Recent Achievements and
Events
- Received positive opinion on
Ondexxya from CHMP.
- Signed $125 million loan agreement
with HealthCare Royalty Partners and Athyrium Capital
Management.
- Published full ANNEXA-4 study
results in The New England Journal of Medicine following
presentation of results at the International Stroke Conference
(ISC) 2019.
- Appointed 30+-year industry veteran
Sheldon Koenig as chief commercial officer.
- Completed cerdulatinib
end-of-phase-2 meeting, which provided guidance on regulatory
pathway for a peripheral T-cell lymphoma (PTCL) registrational
study that is anticipated to begin by year-end.
- Initiated broad U.S. launch of
Andexxa following FDA approval of Gen 2 supply, and expanded sales
force by approximately 40 representatives.
Upcoming Milestones
- Anticipated receipt of C-code from
The Centers for Medicare & Medicaid Services,
allowing hospitals an additional reimbursement pathway for
Andexxa.
- European Commission decision on the
marketing authorization application for Ondexxya expected in early
May 2019.
- 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, Friday, March 1, 2019,
at 8:30 a.m. ET, during which time management will discuss the
fourth quarter and full year 2018 financial results, updates on the
U.S. launch of Andexxa, 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 6999805. 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
December 31, 2018 |
|
|
Twelve Months Ended
December 31, 2018 |
(In thousands, except
per share data) |
GAAP Amount |
|
Non-GAAP Adjustments |
|
Non-GAAP Amount |
|
|
(In thousands, except
per share data) |
GAAP Amount |
|
Non-GAAP Adjustments |
|
Non-GAAP Amount |
|
Product revenue, net |
$ |
14,070 |
|
- |
|
$ |
14,070 |
|
|
Product revenue, net |
$ |
24,117 |
|
- |
|
$ |
24,117 |
|
Collaboration and license revenue |
1,228 |
|
- |
|
1,228 |
|
|
Collaboration and license revenue |
16,013 |
|
- |
|
16,013 |
|
Total revenues |
15,298 |
|
- |
|
15,298 |
|
|
Total revenues |
40,130 |
|
- |
|
40,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
12,401 |
|
(10,311 |
) |
2,090 |
|
|
Cost of sales |
18,081 |
|
(10,311 |
) |
7,770 |
|
Research and development |
49,461 |
|
(9,201 |
) |
40,260 |
|
|
Research and development |
216,205 |
|
(9,201 |
) |
207,004 |
|
Selling, general and administrative |
40,617 |
|
- |
|
40,617 |
|
|
Selling, general and administrative |
151,164 |
|
- |
|
151,164 |
|
Total operating expenses |
102,479 |
|
(19,511 |
) |
82,968 |
|
|
Total operating expenses |
385,450 |
|
(19,511 |
) |
365,939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Portola |
$ |
(88,548 |
) |
19,511 |
|
$ |
(69,037 |
) |
|
Net loss attributable to Portola |
$ |
(350,223 |
) |
19,511 |
|
$ |
(330,712 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic/diluted) |
$ |
(1.33 |
) |
$ |
0.29 |
|
$ |
(1.04 |
) |
|
Net loss per share (basic/diluted) |
$ |
(5.31 |
) |
$ |
0.30 |
|
$ |
(5.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute loss per share |
66,497,034 |
|
|
|
66,497,034 |
|
|
Shares used to compute loss per share |
66,017,330 |
|
|
|
66,017,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes: Non-GAAP adjustments
consist of: (1) A $9.2 million charge associated with the valuation
of the Company equity that will be issued to Lonza, our Andexxa Gen
2 manufacturer, and (2) a $10.3 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
December 31, |
|
|
Twelve Months Ended
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenue, net |
|
$ |
14,070 |
|
|
$ — |
|
|
$ |
24,117 |
|
|
$ — |
|
Collaboration and license revenue |
|
1,228 |
|
|
9,803 |
|
|
16,013 |
|
|
22,546 |
|
Total
revenues |
|
15,298 |
|
|
9,803 |
|
|
40,130 |
|
|
22,546 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
Sales |
|
12,401 |
|
|
260 |
|
|
18,081 |
|
|
415 |
|
Research
and development |
|
49,461 |
|
|
68,491 |
|
|
216,205 |
|
|
203,701 |
|
Selling,
general and administrative |
|
40,617 |
|
|
26,903 |
|
|
151,164 |
|
|
91,109 |
|
Total
operating expenses |
|
102,479 |
|
|
95,654 |
|
|
385,450 |
|
|
295,225 |
|
Loss
from operations |
|
(87,181 |
) |
|
(85,851 |
) |
|
(345,320 |
) |
|
(272,679 |
) |
Interest
and other income (expense), net |
|
4,393 |
|
|
(2,290 |
) |
|
13,516 |
|
|
(1,338 |
) |
Interest
expense |
|
(6,098 |
) |
|
(3,360 |
) |
|
(18,740 |
) |
|
(11,603 |
) |
Net
loss |
|
(88,886 |
) |
|
(91,501 |
) |
|
(350,544 |
) |
|
(285,620 |
) |
Net
(income) loss attributable to noncontrolling interest (SRX
Cardio) |
|
338 |
|
|
(280 |
) |
|
321 |
|
|
(470 |
) |
Net loss
attributable to Portola |
|
$ |
(88,548 |
) |
|
$ |
(91,781 |
) |
|
$ |
(350,223 |
) |
|
$ |
(286,090 |
) |
Net loss
per share attributable to Portola common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(1.34 |
) |
|
$ |
(1.41 |
) |
|
$ |
(5.31 |
) |
|
$ |
(4.81 |
) |
Shares
used to compute net loss per share attributable to Portola common
stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
66,497,034 |
|
|
65,260,653 |
|
|
66,017,330 |
|
|
59,508,156 |
|
Unaudited Condensed Consolidated Balance Sheet
Data |
(In thousands) |
|
|
|
December 31, 2018 |
|
December 31, 2017 |
|
|
Cash, cash equivalents
and investments |
$ |
316,964 |
|
$ |
534,233 |
Trade and other
receivables, net |
5,849 |
|
3,750 |
Unbilled -
collaboration and license revenue |
9,880 |
|
- |
Inventories |
7,873 |
|
1,099 |
Prepaid
expenses and other current assets |
11,699 |
|
9,744 |
Total
current assets |
353,327 |
|
477,923 |
Property
and equipment, net |
5,236 |
|
5,217 |
Intangible
assets |
7,279 |
|
7,851 |
Prepaid and
other long-term assets |
20,577 |
|
9,609 |
Total
assets |
386,419 |
|
571,676 |
Accounts
payable |
13,215 |
|
9,304 |
Accrued
compensation and other liabilities |
22,310 |
|
15,078 |
Accrued
research and development |
19,831 |
|
44,973 |
Deferred
revenue (current portion and long-term) |
6,335 |
|
29,967 |
Current
portion of notes payable and long term debt |
11,802 |
|
- |
Total
current liabilities |
69,005 |
|
80,524 |
Notes
payable, less current portion |
48,298 |
|
50,565 |
Long term
debt, less current portion |
155,256 |
|
54,251 |
Long term
obligation to collaborator, less current portion |
6,881 |
|
8,000 |
Total
liabilities |
295,852 |
|
222,183 |
Total
Portola stockholders’ equity |
88,401 |
|
346,866 |
Noncontrolling interest (SRX Cardio) |
2,166 |
|
2,627 |
Total
stockholders’ equity |
90,567 |
|
349,493 |
Total
liabilities and stockholders’ equity |
386,419 |
|
571,676 |
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, our
intention to conduct a broad commercial launch of Andexxa in the
United States and increase patient access to Andexxa, obtain
regulatory approvals in Europe, advance development of cerdulatinib
and anticipated events discussed under the caption “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 our
products for the indications for which they are 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; the risk
that the EC may not approve Andexxa in the currently anticipated
timelines or at all, and that any marketing approvals or
reimbursement limitations may have significant limitations on its
use; 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 or annual
report filed with the SEC. 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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