Portola Pharmaceuticals Reports Second Quarter 2018 Financial Results and Provides Corporate Update
09 Août 2018 - 2:01PM
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today reported
financial results for the three months ended June 30, 2018 and
provided a corporate update.
“The second quarter of 2018 brought a
significant addition to our product suite with the U.S. Food and
Drug Administration’s Accelerated Approval of Andexxa and the
initiation of our Early Supply Program. Together with Bevyxxa, we
now have two FDA-approved, first-and-only medicines for their
indications in the field of thrombosis with the potential to impact
public health,” said Mardi Dier, interim co-president and chief
financial officer of Portola. “In the second half of the year, we
remain focused on continuing to lay the foundation for the U.S.
launch of Bevyxxa and preparing for a number of significant
milestones, including our regulatory submission in the U.S. for the
Generation 2 Andexxa product, review and potential approval for
andexanet alfa in Europe, and determining the development and
regulatory path forward for cerdulatinib, our Syk/JAK inhibitor and
the third novel compound discovered in our labs.”
Second Quarter 2018 Financial
ResultsTotal revenue for the second quarter of 2018 was
$4.0 million, compared with $3.8 million for the second quarter of
2017. This includes $1.7 million in collaboration and license
revenue earned under Portola’s collaboration and license agreements
with Bristol-Myers Squibb Company, Pfizer, Bayer
Pharma, Janssen Pharmaceuticals and Daiichi Sankyo, as
well as $2.2 million from initial sales of Andexxa in the U.S.
under the Company’s Early Supply Program launched in May 2018, and
$33,000 in product revenue from sales of Bevyxxa, which launched in
the U.S. in January 2018.
Total operating expenses for the second quarter
of 2018 were $107.7 million, compared with $69.6
million for the same period in 2017. Total operating expenses
for the second quarter of 2018 included $13.2 million in
stock-based compensation expense, compared with $13.3
million for the same period in 2017.
Research and development expenses
were $66.4 million for the second quarter of 2018,
compared with $49.3 million for the second quarter of
2017. The increase is due to the second Generation 2 Andexxa
commercial manufacturing campaign. Selling, general and
administrative expenses for the second quarter of 2018
were $40.2 million, compared with $20.3 million for
the same period in 2017. The increase is due to the build-out of
the field force and marketing spend for the Andexxa Early Supply
Program and the Bevyxxa launch.
For the second quarter of 2018, Portola reported
a net loss of $106.2 million, or $1.61 net loss per
share, compared with a net loss of $69.7 million,
or $1.22 net loss per share, for the same period in 2017.
Shares used to compute net loss per share attributable to common
stockholders were 65.9 million for the second quarter of 2018
compared with 57.1 million for the same period in 2017.
Cash, cash equivalents and investments
at June 30, 2018 totaled $456.7 million, compared with
$534.2 million as of December 31, 2017.
Based on the FDA approval of Andexxa
in May 2018, the Company earned an additional $100
million milestone payment from its royalty-based financing
arrangement with Health Care Royalty Partners.
Recent Achievements and
Events
- Received Accelerated Approval from the FDA for Andexxa and
initiated commercial launch under the Early Supply Program.
- Completed the second successful manufacturing campaign of
Generation 2 Andexxa product.
- Continued progress with the Bevyxxa U.S. commercial launch,
including formulary wins, reimbursement coverage and physician
education.
- New interim results from the ongoing Phase 2a study of
cerdulatinib presented at the 2018 American Society of Clinical
Oncology (ASCO) Annual Meeting and 23rd Congress of the European
Hematology Association (EHA).
- Four abstracts presented at the International Society on
Thrombosis and Haemostasis (ISTH) meeting.
- Received New Technology Add-on Payment for Andexxa from the
Centers for Medicare and Medicaid Services.
Upcoming Milestones
- Eight abstracts to be presented at the European Society of
Cardiology (ESC) meeting.
- Submit Prior Approval Supplement (PAS) for Generation 2 Andexxa
product by the end of August, positioning the Company for a broader
commercial launch in early 2019, upon FDA approval.
- On track to deliver additional data to European regulatory
authorities in the fourth quarter, with potential for European
approval of andexanet alfa in the first half of 2019.
- Ongoing discussion with the FDA on the potential regulatory
pathway for cerdulatinib.
Conference Call DetailsPortola
will host a conference call today, Thursday, August 9, 2018,
at 8:30 a.m. ET, during which time management will discuss the
second quarter 2018 financial results, updates on the U.S. launches
of Andexxa and Bevyxxa, 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 6650817. 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.
Unaudited Condensed Consolidated Statements of
Operations |
|
(In thousands, except share and per share
data) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product
revenue, net |
|
$ |
2,265 |
|
|
$ |
— |
|
|
$ |
2,871 |
|
|
$ |
— |
|
|
Collaboration and license revenue |
|
|
1,746 |
|
|
|
3,787 |
|
|
|
7,784 |
|
|
|
8,915 |
|
|
Total
revenues |
|
|
4,011 |
|
|
|
3,787 |
|
|
|
10,655 |
|
|
|
8,915 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of
Sales |
|
|
1,052 |
|
|
|
— |
|
|
|
1,388 |
|
|
|
— |
|
|
Research
and development |
|
|
66,440 |
|
|
|
49,292 |
|
|
|
126,507 |
|
|
|
79,937 |
|
|
Selling,
general and administrative |
|
|
40,214 |
|
|
|
20,329 |
|
|
|
71,755 |
|
|
|
35,350 |
|
|
Total
operating expenses |
|
|
107,706 |
|
|
|
69,621 |
|
|
|
199,650 |
|
|
|
115,287 |
|
|
Loss
from operations |
|
|
(103,695 |
) |
|
|
(65,834 |
) |
|
|
(188,995 |
) |
|
|
(106,372 |
) |
|
Interest
and other income (expense), net |
|
|
1,828 |
|
|
|
(124 |
) |
|
|
5,199 |
|
|
|
289 |
|
|
Interest
expense |
|
|
(4,104 |
) |
|
|
(3,456 |
) |
|
|
(6,685 |
) |
|
|
(5,095 |
) |
|
Net
loss |
|
|
(105,971 |
) |
|
|
(69,414 |
) |
|
|
(190,481 |
) |
|
|
(111,178 |
) |
|
Net
(income) loss attributable to noncontrolling interest (SRX
Cardio) |
|
|
(223 |
) |
|
|
(240 |
) |
|
|
109 |
|
|
|
(195 |
) |
|
Net loss
attributable to Portola |
|
$ |
(106,194 |
) |
|
$ |
(69,654 |
) |
|
$ |
(190,372 |
) |
|
$ |
(111,373 |
) |
|
Net loss
per share attributable to Portola common stockholders: |
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(1.61 |
) |
|
$ |
(1.22 |
) |
|
$ |
(2.90 |
) |
|
$ |
(1.96 |
) |
|
Shares
used to compute net loss per share attributable to Portola common
stockholders: |
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
65,884,767 |
|
|
|
57,050,523 |
|
|
|
65,698,391 |
|
|
|
56,872,644 |
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Balance Sheet
Data |
|
(In thousands) |
|
|
|
|
|
June 30, 2018 |
|
December 31, 2017 |
|
|
(Unaudited) |
|
Cash, cash equivalents
and investments |
|
$ |
456,665 |
|
|
$ |
534,233 |
|
Prepaid
research and development |
|
|
1,282 |
|
|
|
734 |
|
Prepaid
manufacturing |
|
|
17,880 |
|
|
|
2,333 |
|
Trade
and other receivables, net |
|
|
3,421 |
|
|
|
3,750 |
|
Unbilled
- collaboration and license revenue |
|
|
6,491 |
|
|
|
— |
|
Total
current assets |
|
|
478,882 |
|
|
|
477,923 |
|
Property
and equipment, net |
|
|
5,358 |
|
|
|
5,217 |
|
Intangible assets |
|
|
7,567 |
|
|
|
7,851 |
|
Prepaid
and other long-term assets |
|
|
14 |
|
|
|
9,609 |
|
Total
assets |
|
|
512,598 |
|
|
|
571,676 |
|
Accounts
payable |
|
|
6,746 |
|
|
|
9,304 |
|
Accrued
research and development |
|
|
39,015 |
|
|
|
44,973 |
|
Accrued
compensation and other liabilities |
|
|
14,919 |
|
|
|
15,078 |
|
Deferred
revenue (current portion and long-term) |
|
|
10,122 |
|
|
|
29,967 |
|
Current
portion of notes payable and long term debt |
|
|
5,971 |
|
|
|
— |
|
Total
current liabilities |
|
|
71,579 |
|
|
|
80,524 |
|
Notes
payable, less current portion |
|
|
49,937 |
|
|
|
50,565 |
|
Long
term debt, less current portion |
|
|
150,299 |
|
|
|
54,251 |
|
Long
term obligation to collaborator, less current portion |
|
|
7,527 |
|
|
|
8,000 |
|
Total
liabilities |
|
|
292,537 |
|
|
|
222,183 |
|
Total
Portola stockholders’ equity |
|
|
217,683 |
|
|
|
346,866 |
|
Noncontrolling interest (SRX Cardio) |
|
|
2,378 |
|
|
|
2,627 |
|
Total
stockholders’ equity |
|
|
220,061 |
|
|
|
349,493 |
|
Total
liabilities and stockholders’ equity |
|
|
512,598 |
|
|
|
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 and
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, the
statements under the caption “Upcoming Milestones,” and those
regarding potential regulatory approvals, the potential public
health impact of Andexxa and Bevyxxa, and other activities planned
for the second half of 2018. 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 or Bevyxxa for the indications 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 EMA 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 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 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.
Investor Contact: Cara Miller Portola
Pharmaceuticals ir@portola.com
Media Contact: Laurie Masonson Pure
Communications lmasonson@purecommunications.com
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