SOUTH SAN FRANCISCO, Calif.,
May 11, 2020 /PRNewswire/ -- Portola Pharmaceuticals,
Inc.® (Nasdaq: PTLA) today reported financial results
for the three months ended March 31, 2020, and provided a
corporate update, including the Company's actions to continue to
support public health efforts and the health and safety of
employees, patients and healthcare providers during the COVID-19
pandemic.
"2020 started strong with January representing our highest month
of Andexxa demand in the U.S. since launch, driven in part by a
return of growth in our tier one accounts," said Scott Garland, Portola's president and chief executive
officer. "While encouraging, the emergence of the COVID-19 pandemic
impacted our revenue in March and the quarter due to three main
factors. First, market research and customer feedback indicate that
shelter-in-place restrictions issued by over 40 states have led to
fewer patients coming into emergency departments. Second, most
healthcare systems shifted their focus to preparing for and
addressing COVID-19 patients, which impacted the number of new
accounts added in the quarter. Finally, on March 13, we suspended face-to-face field
interactions with healthcare providers. Despite these challenges,
we continue to execute on our growth drivers and make progress with
virtual meetings and education programs to highlight the value
proposition of Andexxa, including recently presented clinical
data."
As previously announced on May 5,
2020, Portola entered into
a definitive merger agreement to be acquired by Alexion
Pharmaceuticals, Inc. (NASDAQ: ALXN). Under the terms of the merger
agreement, a subsidiary of Alexion will commence a tender offer to
acquire all of the outstanding shares of Portola common stock at a
price of $18 per share in cash. The
tender offer is subject to customary conditions, including the
tender of a majority of the outstanding shares of Portola common
stock, the expiration or termination of the waiting period under
the Hart-Scott Rodino Antitrust Improvements Act of 1976 and
receipt of certain other regulatory approvals. Following successful
completion of the tender offer, Alexion will acquire all remaining
shares not tendered in the offer at the same price of $18 per share in cash through a merger. The
transaction is expected to close in the third quarter of 2020.
Quarter Ending March 31, 2020, and Related Financial
Results
- Total global revenues for the first quarter of 2020
were $26.4 million compared with $22.2 million for
the same period in 2019. This includes $25.6 million in
net product revenues from sales of Andexxa/Ondexxya [coagulation
factor Xa (recombinant), inactivated-zhzo], and $0.8
million in collaboration and license revenues.
- Net loss attributable to Portola for the first quarter of 2020
was $68.8 million, or $0.88 net loss per share, compared
with $78.2 million, or $1.17 net loss per share, for
the same period in 2019.
- Total operating expenses for the first quarter of 2020
were $84.8 million, including $9.5
million in stock-based compensation, compared
with $95.8 million for the same period in 2019. Included
in total operating expenses was a stock-based compensation expense
of $9.5 million for the first quarter
of 2020, compared with $17.9 million,
including one-time equity valuation for a manufacturer of
$5.8 million, for the same period in
2019.
- Research and development (R&D) expenses for the first
quarter of 2020 were $26.1 million
compared with $35.6 million for the
same period in 2019. Included in R&D expenses was a stock-based
compensation expense of $2.6 million
for the first quarter of 2020, compared with $10.1 million, including one-time equity
valuation for a manufacturer of $5.8
million, for the same period in 2019.
- Selling, general and administrative (SG&A) expenses for the
first quarter of 2020 were $54.4
million compared with $53.0
million for the same period in 2019. Included in SG&A
expenses was a stock-based compensation expense of $6.9 million for the first quarter of 2020,
compared with $7.8 million for the
same period in 2019.
- Cost of sales (COS) for the first quarter of 2020 was
$4.3 million compared with
$7.2 million for the same period in
2019.
Cash, Cash Equivalents and Investments
Cash, cash equivalents and investments at March 31,
2020, totaled $394.1 million compared with $466.2
million as of December 31, 2019.
Updated 2020 Annual Financial Guidance
Portola is reducing its 2020
operating expenses by approximately $50
million. For the fiscal year 2020, Portola is updating its guidance for R&D
and SG&A expenses. Portola now
expects GAAP R&D expenses to be between $90 million and
$105 million, including stock-based
compensation expenses of approximately $15
million, a decrease of $15
million from the prior guidance range of $105 million and $120
million. Portola now
expects GAAP SG&A expenses to be between $200 million and $215
million, including stock-based compensation expenses of
approximately $38 million, a decrease
of $35 million from the prior
guidance range of $235 million and
$250 million. This updated guidance
reflects near-term cost containment measures to extend the cash
runway as Portola navigates the
COVID-19 pandemic.
With the uncertainty around the duration of COVID-19 impacts,
Portola is suspending prior
guidance provided during its fourth quarter 2019 call for
approximately 350 new hospital adds in 2020.
COVID-19 Response
As the global pandemic continues to evolve rapidly, Portola's first priority is the health and
safety of employees, patients and healthcare providers. Effective
March 13, 2020, the Company suspended
face-to-face field activity and instituted a mandatory
work-from-home policy for all employees, including those in the
Company's South San Francisco and European
headquarters. The Company shifted to a virtual
field force to continue engaging customers with digital tools
and remote meetings where possible. Portola's plan to present and publish data
throughout the year remains intact.
At this time, the global Andexxa supply chain and distribution
structure is intact for customers to continue to use and re-order
Andexxa. Portola has adequate
supply of this important medicine on hand for the next couple of
years in the United States and Europe.
Recent Achievements and Events
- Added 68 new accounts in the first quarter of 2020. Andexxa is
now stocked in over 700 U.S. hospitals.
- Establishment of a permanent J-code for Andexxa by the Centers
for Medicare & Medicaid Services, effective July 1, 2020, ensuring greater patient access by
providing hospitals with a clearer reimbursement pathway when
administering Andexxa in the outpatient hospital setting.
- Presented the budget impact model demonstrating that using
Andexxa may provide a net cost reduction for the treatment of
intracranial hemorrhage (ICH) associated with oral Factor Xa
inhibitors. The analysis, presented at the Emergencies on Medicine
conference, projects that hospital use of Andexxa with NTAP
reimbursement can reduce cost per hospitalization by up to
$5,400 compared to 4F-PCC's.
- Presented new data at ACC demonstrating that Andexxa was
associated with a lower rate of in-hospital and 30-day mortality in
patients with multiple types of life-threatening Factor Xa
inhibitor-related bleeds compared with other treatment options.
Propensity matched data from the ANNEXA-4 and ORANGE studies showed
30-day mortality was 15% with Andexxa versus 34% with 4F-PCC across
all bleed types. Additionally, in a real-world database analysis,
in-hospital mortality was 4% with Andexxa and 10% with 4F-PCC
across all bleed types.
- Agreed to terminate the collaboration and license agreement
with Bristol-Myers Squibb Company and Pfizer, Inc. regarding the
development and commercialization of andexanet alfa in Japan. Portola will regain full Japanese rights for
andexanet alfa. Japan represents
the third largest market for Factor Xa inhibitors after
the United States and the EU 5
countries. Portola will have
exclusive rights to develop and commercialize andexanet alfa in
the United States, Europe, Japan
and rest of the world markets.
Planned Upcoming Milestones
- Present and publish comparative clinical, mechanistic and
economic data supporting the adoption of Andexxa at medical
meetings and in peer-reviewed journals throughout the year
including:
-
- The ANNEXA-4 study ICH subgroup
- Retrospective comparisons of Andexxa vs. 4F-PCC's on clinical
outcomes using data from the ANNEXA-4, ORANGE and RETRACE
studies
- Advance reimbursement discussions in the United Kingdom (2H 2020), Germany (2H 2020) and other Wave 1 European
countries.
- Submit a supplemental Biologics License Application (BLA) to
the U.S. Food and Drug Administration (FDA) by year end for
inclusion of the additional Factor Xa inhibitors edoxaban and
enoxaparin in the Andexxa label.
Unaudited
Condensed Consolidated Statements of Operations
|
(In thousands,
except share and per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
Product revenue,
net
|
|
$
|
25,637
|
|
|
$
|
20,362
|
|
Collaboration and
license revenue
|
|
752
|
|
|
1,807
|
|
Total
revenues
|
|
26,389
|
|
|
22,169
|
|
Operating
expenses:
|
|
|
|
|
Cost of
sales
|
|
4,320
|
|
|
7,150
|
|
Research and
development
|
|
26,089
|
|
|
35,584
|
|
Selling, general and
administrative
|
|
54,418
|
|
|
53,034
|
|
Total operating
expenses
|
|
84,827
|
|
|
95,768
|
|
Loss from
operations
|
|
(58,438)
|
|
|
(73,599)
|
|
Interest and other
expense, net
|
|
(2,186)
|
|
|
1,984
|
|
Interest
expense
|
|
(8,147)
|
|
|
(6,481)
|
|
Net loss
|
|
(68,771)
|
|
|
(78,096)
|
|
Net income
attributable to noncontrolling interest
|
|
—
|
|
|
(60)
|
|
Net loss attributable
to Portola
|
|
$
|
(68,771)
|
|
|
$
|
(78,156)
|
|
Net loss per share
attributable to Portola common stockholders:
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.88)
|
|
|
$
|
(1.17)
|
|
Shares used to
compute net loss per share attributable to Portola common
stockholders:
|
|
|
|
|
Basic and
diluted
|
|
78,171,313
|
|
|
67,070,168
|
|
Unaudited
Condensed Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
Cash, cash
equivalents and investments
|
|
$
|
394,060
|
|
|
$
|
466,244
|
|
Trade and other
receivables, net
|
|
7,410
|
|
|
13,547
|
|
Unbilled -
collaboration and license revenue
|
|
3,408
|
|
|
3,783
|
|
Inventories
|
|
3,576
|
|
|
4,101
|
|
Property and
equipment, net
|
|
4,872
|
|
|
4,264
|
|
Other
assets
|
|
99,980
|
|
|
86,544
|
|
Total
assets
|
|
513,306
|
|
|
578,483
|
|
Total current
liabilities
|
|
80,499
|
|
|
102,418
|
|
Long-term
liabilities
|
|
360,774
|
|
|
346,240
|
|
Total stockholders'
equity
|
|
72,033
|
|
|
129,825
|
|
Total liabilities and
stockholders' equity
|
|
513,306
|
|
|
578,483
|
|
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.
Cautionary Note Regarding Forward-Looking Statements
To the extent that statements contained in this communication
are not descriptions of historical facts, they are forward-looking
statements reflecting the current beliefs, certain assumptions and
current expectations of management and may be identified by words
such as "believes," "plans," "anticipates," "projects,"
"estimates," "expects," "intends," "strategy," "future,"
"opportunity," "may," "will," "should," "could," "potential," or
similar expressions. Such forward-looking statements are based on
management's current expectations, beliefs, estimates, projections
and assumptions. As such, forward-looking statements are not
guarantees of future performance and involve inherent risks and
uncertainties that are difficult to predict. As a result, a number
of important factors could cause actual results to differ
materially from those indicated by such forward-looking statements,
including: the risk that the proposed acquisition of Portola by Alexion may not be completed; the
possibility that competing offers or acquisition proposals for
Portola will be made; the delay or
failure of the tender offer conditions to be satisfied (or waived),
including insufficient shares of Portola common stock being
tendered in the tender offer; the failure (or delay) to receive the
required regulatory approvals of the proposed acquisition; the
possibility that prior to the completion of the transactions
contemplated by the acquisition agreement, Alexion's or
Portola's business may experience
significant disruptions due to transaction-related uncertainty; the
effects of disruption from the transactions of Portola's business and the fact that the
announcement and pendency of the transactions may make it more
difficult to establish or maintain relationships with employees,
manufactures, suppliers, vendors, business partners and
distribution channels to patients; the occurrence of any event,
change or other circumstance that could give rise to the
termination of the acquisition agreement; the risk that stockholder
litigation in connection with the proposed transaction may result
in significant costs of defense, indemnification and liability; the
failure of the closing conditions set forth in the acquisition
agreement to be satisfied (or waived); the anticipated benefits of
Portola's therapy (Andexxa) not
being realized (including expansion of the number of patients using
the therapy); the phase 4 study regarding Andexxa does not meet its
designated endpoints and/or is not deemed safe and effective by the
FDA or other regulatory agencies (and commercial sales are
prohibited or limited); future clinical trials of Portola products not proving that the
therapies are safe and effective to the level required by
regulators; anticipated Andexxa sales targets are not satisfied;
Andexxa does not gain acceptance among physicians, payers and
patients; potential future competition by other Factor Xa inhibitor
reversal agents; decisions of regulatory authorities regarding the
adequacy of the research and clinical tests, marketing approval or
material limitations on the marketing of Portola products; delays or failure of product
candidates or label extension of existing products to obtain
regulatory approval; delays or the inability to launch product
candidates (including products with label extensions) due to
regulatory restrictions; failure to satisfactorily address matters
raised by the FDA and other regulatory agencies; the possibility
that results of clinical trials are not predictive of safety and
efficacy results of products in broader patient populations; the
possibility that clinical trials of product candidates could be
delayed or terminated prior to completion for a number of reasons;
the adequacy of pharmacovigilance and drug safety reporting
processes; and a variety of other risks set forth from time to time
in Alexion's or Portola's filings
with the SEC, including but not limited to the risks discussed in
Alexion's Annual Report on Form 10-K for the year ended
December 31, 2019 and in its other
filings with the SEC and the risks discussed in Portola's Annual Report on Form 10-K for the
year ended December 31, 2019 and in
its other filings with the SEC. The risks and uncertainties may be
amplified by the COVID-19 pandemic, which has caused
significant economic uncertainty. The extent to which
the COVID-19 pandemic impacts Portola's and Alexion's businesses,
operations, and financial results, including the duration and
magnitude of such effects, will depend on numerous factors, which
are unpredictable, including, but not limited to, the duration and
spread of the outbreak, its severity, the actions to contain the
virus or treat its impact, and how quickly and to what extent
normal economic and operating conditions can resume. Alexion and
Portola disclaim any obligation to
update any of these forward-looking statements to reflect events or
circumstances after the date hereof, except as required by law.
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SOURCE Portola Pharmaceuticals, Inc.®