SOUTH SAN FRANCISCO, Calif.,
Jan. 9, 2020 /PRNewswire/ -- Portola
Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced
preliminary unaudited Andexxa global net revenues for the fourth
quarter and full year 2019. For the fourth quarter, the Company
expects Andexxa global net revenues to be approximately
$28 million. For the full year 2019,
the Company expects Andexxa global net revenues to be approximately
$111 million.
In the U.S., net revenues of Andexxa in the fourth quarter 2019
were approximately $24 million, which
compares to net revenues of $14.0
million in the same period a year ago and $33.0 million in third quarter 2019.
In Europe, net revenues of
Ondexxya were approximately $4
million, which compares to net revenues of $2.7 million in the third quarter of 2019. Fourth
quarter 2019 was Ondexxya's first full quarter of sales following
its launch in July 2019 in
Europe, where it is now marketed
in Germany, Austria, the U.K., the Netherlands, Sweden, Denmark and Finland.
During the fourth quarter, approximately 90 new accounts, and
over 425 new accounts in 2019, ordered Andexxa in the U.S. This
brings the total number of accounts now ordering Andexxa to
approximately 640 at the end of 2019. There continues to be a
significant hospital penetration opportunity within the Company's
2,100 target accounts in 2020 and beyond. Also in the fourth
quarter, re-ordering accounts contributed 80% of U.S. revenues,
compared to 76% of revenues in the third quarter.
Fourth quarter Andexxa net sales in the U.S. were impacted
primarily by two factors:
- A $5 million gross to net
adjustment due to a return reserve for short-dated product. The
Company expects this to be mitigated going forward by its current
longer-dated, 36-month product, which began shipping in
November 2019.
- Flat quarter over quarter demand due to a decrease in
utilization, primarily in tier 1 accounts. While physician demand
remains strong, the Company believes that in certain of these
accounts, hospital pharmacies curtailed use of Andexxa following
drug utilization reviews in an effort to manage pharmacy budgets.
Following this reduction, re-ordering patterns are stabilizing in
many of these accounts.
"While we are disappointed in the fourth quarter net revenues
for Andexxa in the U.S., 2019 was a year of significant growth. We
exceeded $100 million in revenues,
including encouraging contributions from our global launch of
Ondexxya, and Andexxa remains on track as one of the top five
hospital drug launches in the U.S. in the last 30 years," said
Scott Garland, Portola's president and chief executive
officer. "Our belief in the long-term potential of Andexxa remains
strong, and we maintain our projection that this highly innovative,
orphan drug has an over $2 billion
opportunity in the rapidly growing FXa-inhibitor market in the U.S.
and Europe. We look forward to continuing to build long-term
revenue growth and value for our shareholders as we establish
Andexxa as the standard for care for doctors addressing the urgent
needs of patients facing serious, life-threatening bleeds."
"Physician support for Andexxa and Ondexxya in the U.S. and
Europe has been tremendous, and we
continue to receive outstanding feedback from members of the
medical community who have seen first-hand the benefits of Andexxa
in treating DOAC-related bleeds," said Sheldon Koenig, Portola's chief commercial officer. "The drug
has excellent efficacy, works fast and is the only FDA-approved
agent available. In 2020, we are moving aggressively to execute on
our launch strategy and build greater awareness of the life-saving
benefits of Andexxa by further educating hospitals on its
value."
2020 Growth Drivers
The Company expects continued strong demand of Andexxa, driven
by the growth of the Factor Xa inhibitor market in the U.S. and
Europe. In 2019, the Factor Xa
inhibitor market volume grew by 27% globally to reach $24 billion. In addition, growth in new hospital
customers and deeper hospital utilization of Andexxa is expected in
2020 driven by:
- Presentation and publication of newly generated health
economics and outcomes research data at multiple medical meetings
starting with three abstracts at the American College of
Cardiology's Annual Scientific Session together with the World
Congress of Cardiology, showing the impact of Andexxa on inpatient
mortality, burden of illness, budget impact model and cost
effective analysis
- Presentation and publication of data demonstrating 4-factor
PCCs, which are only approved to reverse warfarin, are not
effective for reversing Factor Xa related bleeds
- The launch of key educational initiatives to raise awareness of
best practices for the various access and reimbursement pathways
available, including: The New Technology Add-on Payment (NTAP) for
Medicare beneficiaries in the inpatient setting; a pass through
C-code for Medicare and commercial patients in the outpatient
setting; participation in both Medicaid and the 340B drug pricing program; and consignment
opportunities
- Initiation of a single arm study in patients taking Factor Xa
inhibitors that require urgent surgery, providing experience to
inform the design of a randomized clinical trial
- Conclusion of reimbursement discussions in European Wave 1
countries
- Expansion of European launch into Wave 2 countries
The Company has a strong cash position to continue to invest in
the launch of Andexxa and Ondexxya. As of December 31, 2019, the Company's cash position
totaled $464 million, compared with
$317 million as of December 31, 2018.
These preliminary results are based on management's initial
analysis of operations for the quarter ended December 31, 2019. The Company expects to issue
full financial results for the fourth quarter and fiscal year 2019
in late February.
Conference Call Details
The Company will host a live conference call on Thursday, January 9, 2020, at 5:00 p.m. ET, which 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 3995797. The
webcast can also be accessed live on the Investor Relations section
of the Company's website at http://investors.portola.com.
Corporate Update on January 14,
2020
As previously announced, Portola will provide a corporate update on
Tuesday, January 14, at 7:00 a.m. PT (10:00 a.m.
ET). The live webcast will be available on the Company's
website at http://investors.portola.com. A replay of that
presentation will remain available on the website after the live
webcast.
About Portola
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
The preliminary financial results for the fourth quarter and
full year 2019 represent the most current information available to
management and reflect estimates and assumptions. The company's
actual results may differ materially from these preliminary results
due to the completion of the company's financial closing
procedures, final adjustments and other developments that may arise
between the date of this press release and the time that financial
results for the fourth quarter and full year 2019 are finalized.
The foregoing preliminary financial results have not been compiled
or examined by our independent registered public accounting firm
nor have our independent registered public accounting firm
performed any procedures with respect to this information or
expressed any opinion or any form of assurance of such information.
These preliminary financial results should not be viewed as a
substitute for full financial statements prepared in accordance
with U.S. GAAP or as a measure of performance. In addition, these
preliminary financial results are not necessarily indicative of the
results to be achieved for any future period.
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
forward-looking statements include, but are not limited to,
statements regarding the projected over $2
billion Andexxa opportunity, the hospital penetration
opportunity in the Company's target accounts, the anticipated
impact of longer-dated product on future gross to net adjustments,
the potential for Andexxa to be established as a standard of care
and for its launch to be one of the top 5 U.S. hospital drug
launches in the last 30 years, and the Company's anticipated
execution of its clinical and commercial initiatives. 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 or cost-effectiveness of utilizing Andexxa
for the indications for 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 outcomes of
reimbursement discussions in Europe; 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.®