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Portola Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Corporate Update
– First Quarter Revenues of $22.2 Million;
Andexxa® Product Revenues Grow 45% to
– European Commission Approval of Ondexxya®; Staged Commercial Launch Planned in Second Half of 2019 –
– Conference Call Today at
“Our first quarter results continue to reflect strong demand for Andexxa, as well as focused execution on our commercial launch. The full commercial U.S. launch of Andexxa is off to a great start, and with approval of Ondexxya in
- Total revenues for the first quarter of 2019 were $22.2 million, compared with $6.6 million for the first quarter of 2018. This includes $20.3 million in net product revenues from Andexxa sales, $77 thousand in revenues from Bevyxxa® sales and $1.8 million in collaboration and license revenues. 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 $78.2 million for the first quarter of 2019, or $1.17 net loss per share, compared with a net loss of $84.2 million, or $1.28 net loss per share, for the same period in 2018. This includes the effect of two charges taken in the first quarter related to the
U.S. Food and Drug Administration( FDA) approval of the Company’s Gen 2 manufacturing process. The first is a $5.8 millioncharge 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 $3.9 millioncharge 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 first quarter of 2019 was
$68.4 million, or a non-GAAP basic and diluted loss per share of $1.02. Non-GAAP net loss and net 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 March 31, 2019 totaled $322.8 million, compared with $317.0 million as of December 31, 2018. In March, the Company entered into a
$125 millionloan agreement and received an initial tranche of $62.5 million, with the balance available at Portola’s option in the third quarter, subject to certain conditions, extending our cash runway to the end of 2020.
- Total operating expenses for the first quarter of 2019 were $95.8 million, compared with $91.9 million for the same period in 2018. The increase was driven by the timing of launch activities in the U.S., the build-out of the Company’s field force and launch preparations in
- Non-GAAP total operating expenses, which excludes the two charges outlined above, were
$86.0 millionfor the first quarter of 2019. 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 first quarter of 2019 was $17.9 million, compared with $11.0 million for the same period in 2018. This year-over-year increase was driven primarily by the equity issued for the manufacturing site charge.
- Cost of Sales (COS) for the first quarter of 2019 were $7.2 million, compared to $336 thousand for the same period in 2018. The increase was driven by the launch of Andexxa and the Gen 1 supply charge.
- Research and development (R&D) expenses were $35.6 million for the first quarter of 2019, compared with $60.1 million for the first quarter of 2018. The decrease was driven primarily by 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 first quarter of 2019 were $53.0 million, compared with $31.5 million for the same period in 2018. The increase was driven by the expansion of the Company’s field force, commercial activities to support the launch of Andexxa and launch preparations in
Recent Achievements and Events
Received European Commissionapproval of Ondexxya and hired Head of Europeto build a team to support planned commercial activity.
- Received C-code from
The Centers for Medicare & Medicaid Services, allowing hospitals an additional reimbursement pathway for Andexxa.
- Submitted additional data to the FDA on the proposed dose for cerdulatinib.
- Announced the retirements of Portola co-founder
Charles Homcy, M.D. from the Board of Directors, and John Curnutte, M.D., Ph.D., Executive Vice President of Research and Development.
- Staged launch of Ondexxya in a select group of high-potential European countries where Factor Xa inhibitor use is among the highest.
- Present new data on:
- The impact of Andexxa on patients with an intracranial hemorrhage at the
European Stroke Organization Conferencein Milanin May.
- The question of whether PCCs have clinical activity in the reversal of direct FXa inhibitors at the
International Society of Thrombosis and Hematologymeeting in Melbourne.
- The safety and efficacy of cerdulatinib in relapsed/refractory follicular lymphoma, either alone or in combination with rituximab.
- The impact of Andexxa on patients with an intracranial hemorrhage at the
- Initiate discussions with the
FDAon 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 Details
Portola will host a conference call today,
Use of Non-GAAP Financial Measures
This 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 March 31, 2019|
|(In thousands, except per share data)||GAAP
|Product revenue, net||$||20,362||-||$||20,362|
|Collaboration and license revenue||1,807||-||1,807|
|Cost of sales||7,150||(3,949||)||3,201|
|Research and development||35,584||(5,824||)||29,760|
|Selling, general and administrative||53,034||-||53,034|
|Total operating expenses||95,768||(9,773||)||85,995|
|Net loss attributable to Portola||$||(78,156||)||9,773||$||(68,383||)|
|Net loss per share (basic/diluted)||$||(1.17||)||$||0.15||$||(1.02||)|
|Shares used to compute loss per share||67,070,168||67,070,168|
|Notes: Non-GAAP adjustments consist of: (1) A $5.8 million charge associated with the valuation of the Company equity that was issued in 1Q'19 to Lonza, our Andexxa Gen 2 manufacturer, and (2) a $3.9 million charge associated with our Andexxa Gen 1 product as we transition hospitals to Gen 2 product, following approval on December 31, 2018.|
|Unaudited Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended March 31,|
|Product revenue, net||$||20,362||$||606|
|Collaboration and license revenue||1,807||6,038|
|Cost of Sales||7,150||336|
|Research and development||35,584||60,067|
|Selling, general and administrative||53,034||31,541|
|Total operating expenses||95,768||91,944|
|Loss from operations||(73,599||)||(85,300||)|
|Interest and other expense, net||1,984||3,371|
|Net (income) loss attributable to noncontrolling interest||(60||)||332|
|Net loss attributable to Portola||$||(78,156||)||$||(84,178||)|
|Net loss per share attributable to Portola common stockholders:|
|Basic and diluted||$||(1.17||)||$||(1.28||)|
|Shares used to compute net loss per share attributable to Portola common stockholders:|
|Basic and diluted||67,070,168||65,509,945|
|Unaudited Condensed Consolidated Balance Sheet Data|
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and investments||$||322,841||$||316,964|
|Trade and other receivables, net||11,787||5,849|
|Unbilled - collaboration and license revenue||6,317||9,880|
|Property and equipment, net||5,032||5,236|
|Total stockholders’ equity||50,650||90,567|
|Total liabilities and stockholders’ equity||$||400,382||$||386,419|
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 the anticipated launch timing, strategy and revenues for Ondexxya in
Source: Portola Pharmaceuticals, Inc.