Portola Pharmaceuticals Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Corporate Update
SOUTH SAN FRANCISCO, Calif., Feb. 26, 2020 /PRNewswire/ -- Portola Pharmaceuticals, Inc.(®) (Nasdaq: PTLA) today reported financial results for the fourth quarter and full year ended December 31, 2019.
"2019 was a year of significant accomplishments for Portola with the launch of our Gen 2 formulation of Andexxa in the United States and the approval and launch of Ondexxya in Europe. In 2020 we have several catalysts that we expect to drive further adoption and growth worldwide," said Scott Garland, Portola's president and chief executive officer. "This includes the presentation of new clinical data, enhanced education and support related to reimbursement, the initiation of our urgent surgery study, and continued execution of the Ondexxya launch in Europe. Combined with the robust growth in the Factor Xa inhibitor market and our other strategic initiatives, we are confident that Andexxa has significant long-term growth potential."
Quarter Ending December 31, 2019, and Full-Year 2019 Financial Results
-- Total global revenues for the fourth quarter of 2019 were $29.2 million
compared with $15.3 million for the fourth quarter of 2018. This
includes $28.4 million in net product revenues from sales of
Andexxa/Ondexxya [coagulation factor Xa (recombinant),
inactivated-zhzo], and $0.9 million in collaboration and license
revenues. Total global revenues for the full year 2019 were $116.6
million compared with $40.1 million for the full year 2018. This
includes $111.5 million in net product revenues from sales of
Andexxa/Ondexxya, and $5.0 million in collaboration and license
revenues.
-- Net loss attributable to Portola was $96.7 million, or $1.24 net loss
per share for the fourth quarter of 2019, compared with a net loss of
$88.5 million, or $1.34 net loss per share, for the same period in 2018.
Net loss attributable to Portola was $290.7 million, or $4.06 net loss
per share for the full year 2019, compared with a net loss of $350.2
million, or $5.31 net loss per share, for the full year 2018. This
includes the effect of a $27.5 million charge taken in the fourth
quarter of 2019 for Bevyxxa inventory and manufacturing related to the
decision to discontinue the commercialization of Bevyxxa, and a $3.2
million impairment charge taken in the second quarter of 2019 related to
the discontinuation of our SRX program.
-- Non-GAAP net loss for the fourth quarter of 2019 was $58.3 million, or a
non-GAAP basic and diluted loss per share of $0.75. For the full year
2019, non-GAAP net loss was $198.2 million, or a non-GAAP basic and
diluted loss per share of $2.77. Non-GAAP net loss and loss per share
have been adjusted to exclude the Bevyxxa inventory and manufacturing
charge and an impairment charge as well as stock-based compensation
expenses. Please see the reconciliation of GAAP to non-GAAP financial
measures at the end of this release for more details.
-- Total operating expenses for the fourth quarter of 2019 were $119.4
million compared with $102.5 million for the same period in 2018. Total
operating expenses for the full year 2019 were $387.9 million, compared
with $385.5 million for the full year 2018.
-- Non-GAAP total operating expenses, which excludes the Bevyxxa inventory
and manufacturing charge and impairment charge as well as stock based
compensation expenses, were $81.1 million for the fourth quarter of
2019, and $295.5 million for the full year 2019. Please see the
reconciliation of GAAP to non-GAAP financial measures table at the end
of this release for more details.
-- Research and development (R&D) expenses were $29.9 million for the
fourth quarter of 2019, compared with $49.5 million for the fourth
quarter of 2018. R&D expenses for the full year 2019 were $124.6
million, compared with $216.2 million, for the full year 2018. The
decrease in both periods is primarily due to 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 fourth
quarter 2019 were $60.0 million compared with $40.6 million for the
fourth quarter of 2018. SG&A expenses for the full year 2019 were $218.9
million compared with $151.2 million for the full year 2018. The
increase in both periods is due to commercial costs to support the
launch of Andexxa, including the expansion of the field sales teams and
support for the launch of Ondexxya in Europe.
-- Cost of sales (COS) for the fourth quarter of 2019 was $29.6 million
compared to $12.4 million for the same period in 2018. COS for the full
year 2019 was $44.4 million compared with $18.1 million for the full
year 2018. The increase in both periods is due to a charge for Bevyxxa
inventory and manufacturing as the Company winds down that program.
-- Please see the GAAP to non-GAAP reconciliation table at the end of this
release for a detailed breakdown.
Cash, Cash Equivalents and Investments:
-- Cash, cash equivalents and investments at December 31, 2019, totaled
$466.2 million, compared with $317.0 million as of December 31, 2018.
During the fourth quarter, the Company drew down the remaining $62.5
million available under its $125.0 million loan agreement with
HealthCare Royalty Partners (HCR) and investment funds manager Athyrium
Capital Management, LP.
2020 Annual Financial Guidance
For the fiscal year 2020, Portola expects total R&D expenses to be between $105 million and $120 million, including stock-based compensation expenses of approximately $14 million. Portola expects total SG&A expenses to be between $235 million and $250 million, including stock-based compensation expenses of approximately $38 million.
Recent Achievements and Events
-- Completed an internal restructuring to align resources to drive Andexxa
growth including the discontinuation of commercialization and partnering
efforts for Bevyxxa. In addition, the Company has decided not to
initiate the CELTIC-1 trial for the SYK/JAK inhibitor cerdulatinib until
a partner is identified.
-- Initiated the single-arm urgent surgery study for Andexxa, ANNEXA-S.
-- Andexxa was highlighted as a first-line Factor Xa reversal option by the
American College of Emergency Physicians in recommendations published in
the Annals of Emergency Medicine, bringing the total number of guideline
inclusions to 19.
-- Presented multiple abstracts related to cerdulatinib at the American
Society of Hematology 2019 Annual Meeting in December. The data
demonstrated good tolerability and clinical response in patients with
relapsed/refractory peripheral T-cell lymphoma (PTCL) and cutaneous
T-cell lymphoma (CTCL), including a 52% overall response rate in
patients with angioimmunoblastic T-cell lymphoma (AITL), and a 76%
overall response rate in patients with follicular lymphoma treated with
cerdulatinib in combination with rituximab.
-- Appointed 20-year industry veteran Rajiv Patni, M.D., as executive vice
president and chief medical officer, with responsibility for leading
Clinical Development, Clinical Operations, Medical Affairs, Regulatory
Affairs, Biometrics, Pharmacovigilance and Project Management.
-- Launched support of the American Heart Association's(®) hospital-based
quality improvement initiative for enhanced awareness and understanding
of best care practices for hemorrhagic stroke.
Planned Upcoming Milestones
-- Present and publish clinical, research and HEOR studies supporting the
adoption of Andexxa at medical meetings and in peer-reviewed journals
throughout the year, starting with the presentation of three abstracts
at the American College of Cardiology 2020 Annual Meeting in March.
-- Secure reimbursement coverage in the United Kingdom (mid-June 2020),
Germany (2H 2020) and other Wave 1 European countries.
-- Continue launch of Ondexxya into Wave 2 countries in Europe, which
include the additional EU5 countries of France, Spain, and Italy.
Conference Call Details
Portola will host a conference call today, Wednesday, February 26, 2020, at 4:30 p.m. ET, during which time management will discuss the fourth quarter and full-year 2019 financial results, updates on the U.S. and European launches of Andexxa/Ondexxya, and its operations. The live call 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 6192918. 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 Measures
This press release and the reconciliation table included herein include non-GAAP R&D 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 Information."
Unaudited Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
Three Months Ended December 31, Twelve Months Ended December 31,
2019 2018 2019 2018
Revenues:
Product revenue, net $
28,375 $
14,070 $
111,644 $
24,117
Collaboration and license revenue 873 1,228 4,996 16,013
Total revenues 29,248 15,298 116,640 40,130
Operating expenses:
Cost of sales 29,553 12,401 44,378 18,081
Research and development 29,858 49,461 124,627 216,205
Selling, general and administrative 59,980 40,617 218,919 151,164
Total operating expenses 119,391 102,479 387,924 385,450
Loss from operations (90,143) (87,181) (271,284) (345,320)
Interest and other income, net 1,740 4,393 9,698 13,516
Interest expense (8,273) (6,098) (31,290) (18,740)
Net loss (96,676) (88,886) (292,876) (350,544)
Net loss attributable to
noncontrolling interest 338 2,213 321
Net loss attributable to Portola $
(96,676) $
(88,548) $
(290,663) $
(350,223)
Net loss per share attributable to
Portola common stockholders:
Basic and diluted $
(1.24) $
(1.34) $
(4.06) $
(5.31)
Shares used to compute net loss per
share attributable to Portola common
stockholders:
Basic and diluted 77,870,113 66,497,034 71,555,220 66,017,330
Unaudited Condensed Consolidated Balance Sheet Data
(In thousands)
December 31, 2019 December 31, 2018
(Unaudited)
Cash, cash equivalents and
investments $
466,244 $
316,964
Trade and other
receivables, net 13,547 5,849
Unbilled -collaboration
and license revenue 3,783 9,880
Inventories 4,101 7,873
Property and equipment,
net 4,264 5,236
Intangible assets 7,279
Other assets 86,543 33,338
Total assets 578,483 386,419
Total current liabilities 102,418 69,005
Long-term liabilities 346,240 226,847
Total stockholders' equity 129,825 90,567
Total liabilities and
stockholders' equity 578,483 386,419
PORTOLA PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Financial Information
(In thousands, except for per share data)
Three Months Ended December 31, Twelve Months Ended December 31,
2019 2018 2019 2018
Reconciliation of cost of sales:
GAAP cost of sales $
29,553 $
12,401 $
44,378 $
18,081
Gen1 transition (10,311) (3,949) (10,311)
Bevyxxa impairment (27,451) (27,451)
Non-GAAP cost of sales $
2,102 $
2,090 $
12,978 $
7,770
Reconciliation of research and
development:
GAAP research and development $
29,858 $
49,461 $
124,627 $
216,205
Stock-based compensation
expense (1,903) (13,543) (19,340) (27,694)
SRX intangible impairment (3,151)
Equity valuation to manufacturer (9,201) (5,824) (9,201)
Non-GAAP research and
development expenses $
27,955 $
26,717 $
96,312 $
179,310
Reconciliation of selling,
general and administrative
expenses:
GAAP selling, general and
administrative expenses $
59,980 $
40,617 $
218,919 $
151,164
Stock-based compensation
expense (8,979) (7,276) (32,735) (28,712)
Non-GAAP selling, general and
administrative expenses $
51,001 $
33,341 $
186,184 $
122,452
Reconciliation of total
operating expenses:
GAAP total operating expenses $
119,391 $
102,479 $
387,924 $
385,450
Gen1 transition (10,311) (3,949) (10,311)
Bevyxxa impairment (27,451) (27,451)
Stock-based compensation
expense (10,882) (20,819) (52,075) (56,406)
SRX intangible impairment (3,151)
Equity valuation to manufacturer (9,201) (5,824) (9,201)
Non-GAAP total operating
expenses $
81,058 $
62,148 $
295,474 $
309,532
Reconciliation of net loss
attributable to Portola:
GAAP net loss attributable to
Portola shareholders $
(96,676) $
(88,548) $
(290,663) $
(350,223)
Gen1 transition 10,311 3,949 10,311
Bevyxxa impairment 27,451 27,451
Stock-based compensation
expense 10,882 20,819 52,075 56,406
SRX intangible impairment 3,151
Equity valuation to manufacturer 9,201 5,824 9,201
Non-GAAP net loss attributable
to Portola shareholders $
(58,343) $
(48,217) $
(198,213) $
(274,305)
Reconciliation of diluted net
loss per share:
GAAP net loss per share $
(1.24) $
(1.34) $
(4.06) $
(5.31)
Gen1 transition 0.16 0.06 0.16
Bevyxxa impairment 0.35 0.38
Stock-based compensation
expense 0.14 0.31 0.73 0.85
SRX intangible impairment 0.04
Equity valuation to manufacturer 0.14 0.08 0.14
Non-GAAP net loss per share $
(0.75) $
(0.73) $
(2.77) $
(4.16)
Shares used to compute loss per
share 77,870,113 66,497,034 71,555,220 66,017,330
Non-GAAP adjustment summary:
Cost of sales $
(27,451) $
(10,311) $
(31,400) $
(10,311)
Research and development (1,903) (22,744) (28,315) (36,895)
Selling, general and
administrative expenses (8,979) (7,276) (32,735) (28,712)
Total non-GAAP adjustments $
(38,333) $
(40,331) $
(92,450) $
(75,918)
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.
Forward-Looking Statements
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 statements include, but are not limited to, statements regarding our Andexxa program, including our intention to present new clinical data enhanced education and support related to reimbursement, the initiation of our urgent surgery study, and continued execution of the Ondexxya launch in Europe; statements regarding our expected financial performance, including our 2020 financial guidance, and other objectives described under the caption "Planned and 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 Andexxa for the indications which it is approved; we do not receive favorable pricing reimbursement in the United Kingdom and Germany and other EU countries; 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 clinical trials may take longer and be more costly than anticipated; our ability to grow our commercial operations in the EU and generate product revenue within projected timelines and budget; 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 annual report on Form 10-K and 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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