0001628280-19-013326.txt : 20191105 0001628280-19-013326.hdr.sgml : 20191105 20191105161245 ACCESSION NUMBER: 0001628280-19-013326 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20191105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20191105 DATE AS OF CHANGE: 20191105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PORTOLA PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001269021 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35935 FILM NUMBER: 191193430 BUSINESS ADDRESS: STREET 1: 270 EAST GRAND AVENUE, SUITE 22 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-244-6864 MAIL ADDRESS: STREET 1: 270 EAST GRAND AVENUE, SUITE 22 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 a8-kportola11519.htm 8-K Document
false0001269021 0001269021 2019-11-05 2019-11-05


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 5, 2019
 
Portola Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
001-35935
20-0216859
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
 
 
 
270 E. Grand Avenue
 

South San Francisco
California
94080
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (650) 246-7300
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
Common Stock
 
PTLA
 
The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.





Item 2.02 Results of Operations and Financial Condition
On November 5, 2019, Portola Pharmaceuticals, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2019. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits





SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
Portola Pharmaceuticals, Inc.
Dated: November 5, 2019
 
 
 
 
 
By:
/s/ Mike Ouimette
 
 
 
Mike Ouimette
 
 
 
Vice President and Assistant Corporate Secretary, Legal



EX-99.1 2 ex991.htm EX-99.1 Exhibit


Exhibit 99.1
logoa01.jpg
Portola Pharmaceuticals Reports Third Quarter 2019 Financial Results
and Provides Corporate Update
– Andexxa®/Ondexxya® Net Product Revenues of $35.7 million, a 32% Increase Over the Prior Quarter –
– Andexxa Now Stocked in Approximately 550 U.S. Hospitals; 76% of U.S. Sales from Reorders –
– Expanded Market Opportunity with Strong Initial Ondexxya Demand in Europe –
– Strengthened Balance Sheet; Added Net Proceeds of $245 million in Third Quarter–
South San Francisco, Calif., (November 5, 2019) – Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today reported financial results for the three months ended September 30, 2019, and provided a corporate update.
“We delivered another quarter of strong Andexxa revenue in the U.S. and expanded our growth potential with our first sales of Ondexxya in Europe. The use of Factor Xa inhibitors in both markets continues to grow, driving the underlying market opportunity for Andexxa/Ondexxya and long-term value of Portola,” said Scott Garland, Portola’s president and chief executive officer. “Looking forward, we will continue to focus on exceptional launch execution, leveraging external support from health authorities and favorable society guidelines, and building the clinical evidence and awareness of Andexxa. In addition, we remain on track to initiate a registration trial for cerdulatinib in early 2020 and will present updated data at the ASH meeting in December.”
Product Sales:
Total global revenues for the third quarter of 2019 were $36.8 million compared with $14.2 million for the third quarter of 2018. This includes $35.7 million in net product revenues from sales of Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], $17,000 in revenues from Bevyxxa® (betrixaban) sales and $1.1 million in collaboration and license revenues.
Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP) was $49.6 million, or $0.68 net loss per share for the third quarter of 2019, compared with a net loss of $71.3 million, or $1.08 net loss per share, for the same period in 2018.
Operating Expenses:
For the third quarter of 2019, compared to the same period in 2018:
Research and development (R&D) expenses decreased by $14.6 million, or 36.3%, 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 increased by $13.3 million, or 34.2%, due to commercial costs to support the Andexxa launch including the expansion of the field sales teams and launch preparations in Europe.
Cost of Sales (COS) were $2.7 million for the third quarter of 2019, compared to $4.3 million for the same period in 2018. This decrease was primarily due to transition from our Gen 1 to our Gen 2 Andexxa product.
These amounts on a GAAP and non-GAAP basis are reflected in the table below. A table reflecting the reconciliation of GAAP to non-GAAP amounts is included at the end of this release.





 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
(In thousands)
 
2019
 
2018
 
2019
 
2018
Cost of Sales
 
$
2,684

 
$
4,292

 
$
14,825

 
$
5,680

Non-GAAP cost of sales
 
$
2,684

 
$
4,292

 
$
10,876

 
$
5,680

 
 
 
 
 
 
 
 
 
Research and development expenses
 
$
25,647

 
$
40,237

 
$
94,769

 
$
166,744

Non-GAAP research and development expenses
 
$
21,916

 
$
35,858

 
$
68,358

 
$
152,593

 
 
 
 
 
 
 
 
 
Selling, general and administrative expenses
 
$
52,050

 
$
38,792

 
$
158,939

 
$
110,547

Non-GAAP selling, general and administrative expenses
 
$
44,735

 
$
31,778

 
$
135,183

 
$
89,111

 
 
 
 
 
 
 
 
 
Totaling operating expenses
 
$
80,381

 
$
83,321

 
$
268,533

 
$
282,971

Non-GAAP Total operating expenses
 
$
69,335

 
$
71,928

 
$
214,416

 
$
247,384

Cash, Cash Equivalents and Investments:
Cash, cash equivalents and investments at September 30, 2019, totaled $476.8 million, compared with $317.0 million as of December 31, 2018. During the third quarter, the Company added net proceeds of $245 million in connection with the follow on offering of the Company’s common stock.
Recent Achievements and Events
 
Ondexxya launched with $2.7 million of European net sales in the third quarter of 2019.
Andexxa added to the Veteran’s Health Administration national formulary, making access to 170 VA hospitals across the U.S. possible.
Andexxa recommended as first line therapy by The American Academy of Family Physicians (AAFP).
Centers for Medicare and Medicaid Services (CMS) New Technology Add-on Payment (NTAP) reimbursement for Andexxa increased from 50% to 65% effective on October 1, 2019.
Presented sub-analysis of ANNEXA-4 study at the American College of Gastroenterology annual meeting, highlighting the efficacy and safety of Andexxa in Factor Xa patients with acute gastrointestinal bleeding, which demonstrated excellent or good hemostasis achieved in 82% of evaluable patients.
Presented in vitro data at International Society of Thrombosis and Hemostasis annual meeting, demonstrating that four-factor prothrombin complex concentrate (4F-PCC) does not appear to have an effect on the inhibition of thrombin generation by apixaban or rivaroxaban unless the Factor Xa inhibitor concentration was less than 75 ng/mL. In contrast, data from the same thrombin generation assay demonstrated that Andexxa fully corrected the inhibition of thrombin generation by apixaban and rivaroxaban across a broad range of inhibitor concentrations.
Net proceeds of $245 million raised in a public offering of the Company's common stock.
Planned Upcoming Milestones
 
Continue launch of Ondexxya in a select group of high-potential European countries with significant usage of Factor Xa inhibitors and supportive access and reimbursement.
Plan to initiate an urgent surgery study for Andexxa by year end or in early 2020.
Plan to launch a cerdulatinib registration study in peripheral T-cell lymphoma (PTCL) in early 2020.
Multiple abstracts related to Andexxa and cerdulatinib accepted for presentation at the American Society of Hematology annual meeting in December.
Analyst and Investor Meeting
Portola will host an analyst and investor meeting focused on Andexxa on Thursday, November 14, 2019, from 8:00 to 10:30 a.m. ET in New York. Seating is limited to those who RSVP. Please contact events@portola.com for an invitation. The event will also be webcast live and can be accessed live on the Investor Relations section of the Company’s website at http://investors.portola.com. It will be archived for one year following the date of the event.





Conference Call Details
Portola will host a conference call today, Tuesday, November 5, 2019, at 4:30 p.m. ET, during which time management will discuss the third quarter 2019 financial results, updates on the U.S. and European launch 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 2980632. 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.”
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 the anticipated initiation of a registrational trial for cerdulatinib in PTCL, the growing demand for our products, our continued commercial launch for Ondexxya in Europe, our ability to leverage external support from health authorities and build clinical evidence and awareness of Andexxa and our plans to present new data and continue development of our products and product candidates. 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 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 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.






Unaudited Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
 
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
 
Product revenue, net
 
$
35,743

 
$
7,176

 
$
83,269

 
$
10,047

Collaboration and license revenue
 
1,056

 
7,001

 
4,123

 
14,785

Total revenues
 
36,799

 
14,177

 
87,392

 
24,832

Operating expenses:
 
 
 
 
 
 
 
 
Cost of sales
 
2,684

 
4,292

 
14,825

 
5,680

Research and development
 
25,647

 
40,237

 
94,769

 
166,744

Selling, general and administrative
 
52,050

 
38,792

 
158,939

 
110,547

Total operating expenses
 
80,381

 
83,321

 
268,533

 
282,971

Loss from operations
 
(43,582
)
 
(69,144
)
 
(181,141
)
 
(258,139
)
Interest and other income, net
 
1,953

 
3,924

 
7,958

 
9,123

Interest expense
 
(7,998
)
 
(5,957
)
 
(23,017
)
 
(12,642
)
Net loss
 
(49,627
)
 
(71,177
)
 
(196,200
)
 
(261,658
)
Net (income) loss attributable to noncontrolling interest
 

 
(126
)
 
2,213

 
(17
)
Net loss attributable to Portola
 
$
(49,627
)
 
$
(71,303
)
 
$
(193,987
)
 
$
(261,675
)
Net loss per share attributable to Portola common stockholders:
 
 
 
 
 
 
 
 
Basic and diluted
 
$
(0.68
)
 
$
(1.08
)
 
$
(2.79
)
 
$
(3.97
)
Shares used to compute net loss per share attributable to Portola common stockholders:
 
 
 
 
 
 
 
 
Basic and diluted
 
73,017,609

 
66,165,104

 
69,427,124

 
65,855,672



Unaudited Condensed Consolidated Balance Sheet Data
(In thousands)
 
 
 
September 30, 2019
 
December 31, 2018
 
 
(Unaudited)
Cash, cash equivalents and investments
 
$
476,807

 
$
316,964

Trade and other receivables, net
 
18,236

 
5,849

Unbilled - collaboration and license revenue
 
3,788

 
9,880

Inventories
 
2,357

 
7,873

Property and equipment, net
 
4,561

 
5,236

Intangible assets
 
3,699

 
7,279

Other assets
 
67,737

 
33,338

Total assets
 
577,185

 
386,419

Total current liabilities
 
87,491

 
69,005

Long-term liabilities
 
276,806

 
226,847

Total stockholders’ equity
 
212,888

 
90,567

Total liabilities and stockholders’ equity
 
577,185

 
386,419






PORTOLA PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Financial Information
(In thousands, except for per share data)
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
2019
 
2018
 
2019
 
2018
Reconciliation of cost of sales:
 
 
 
 
 
 
 
 
GAAP cost of sales
 
$
2,684

 
$
4,292

 
$
14,825

 
$
5,680

Gen1 transition
 

 

 
(3,949
)
 

Non-GAAP cost of sales
 
$
2,684

 
$
4,292

 
$
10,876

 
$
5,680

 
 
 
 
 
 
 
 
 
Reconciliation of research and development:
 
 
 
 
 
 
 
 
GAAP research and development
 
$
25,647

 
$
40,237

 
$
94,769

 
$
166,744

Stock-based compensation expense
 
(3,731
)
 
(4,379
)
 
(17,437
)
 
(14,151
)
SRX intangible impairment
 

 

 
(3,151
)
 

Equity valuation to manufacturer
 

 

 
(5,824
)
 

Non-GAAP research and development expenses
 
$
21,916

 
$
35,858

 
$
68,358

 
$
152,593

 
 
 
 
 
 
 
 
 
Reconciliation of selling, general and administrative expenses:
 
 
 
 
 
 
 
 
GAAP selling, general and administrative expenses
 
$
52,050

 
$
38,792

 
$
158,939

 
$
110,547

Stock-based compensation expense
 
(7,315
)
 
(7,014
)
 
(23,756
)
 
(21,436
)
Non-GAAP selling, general and administrative expenses
 
$
44,735

 
$
31,778

 
$
135,183

 
$
89,111

 
 
 
 
 
 
 
 
 
Reconciliation of total operating expenses:
 
 
 
 
 
 
 
 
GAAP total operating expenses
 
$
80,381

 
$
83,321

 
$
268,533

 
$
282,971

Gen1 transition
 

 

 
(3,949
)
 

Stock-based compensation expense
 
(11,046
)
 
(11,393
)
 
(41,193
)
 
(35,587
)
SRX intangible impairment
 

 

 
(3,151
)
 

Equity valuation to manufacturer
 

 

 
(5,824
)
 

Non-GAAP total operating expenses
 
$
69,335

 
$
71,928

 
$
214,416

 
$
247,384

 
 
 
 
 
 
 
 
 
Reconciliation of net loss attributable to Portola:
 
 
 
 
 
 
 
 
GAAP net loss attributable to Portola shareholders
 
$
(49,627
)
 
$
(71,303
)
 
$
(193,987
)
 
$
(261,675
)
Gen1 transition
 

 

 
3,949

 

Stock-based compensation expense
 
11,046

 
11,393

 
41,193

 
35,587

SRX intangible impairment
 

 

 
3,151

 

Equity valuation to manufacturer
 

 

 
5,824

 

Non-GAAP net loss attributable to Portola shareholders
 
$
(38,581
)
 
$
(59,910
)
 
$
(139,870
)
 
$
(226,088
)
 
 
 
 
 
 
 
 
 
Reconciliation of diluted net loss per share:
 
 
 
 
 
 
 
 
GAAP net loss per share
 
$
(0.68
)
 
$
(1.08
)
 
$
(2.79
)
 
$
(3.97
)
Gen1 transition
 

 

 
0.06

 

Stock-based compensation expense
 
0.15

 
0.17

 
0.59

 
0.54

SRX intangible impairment
 

 

 
0.05

 

Equity valuation to manufacturer
 

 

 
0.08

 

Non-GAAP net loss per share
 
$
(0.53
)
 
$
(0.91
)
 
$
(2.01
)
 
$
(3.43
)





 
 
 
 
 
 
 
 
 
Shares used to compute loss per share
 
73,018

 
66,165

 
69,427

 
65,856

 
 
 
 
 
 
 
 
 
Non-GAAP adjustment summary:
 
 
 
 
 
 
 
 
Cost of sales
 
$

 
$

 
$
(3,949
)
 
$

Research and development
 
(3,731
)
 
(4,379
)
 
(26,412
)
 
(14,151
)
Selling, general and administrative expenses
 
(7,315
)
 
(7,014
)
 
(23,756
)
 
(21,436
)
Total non-GAAP adjustments
 
$
(11,046
)
 
$
(11,393
)
 
$
(54,117
)
 
$
(35,587
)
# # #
 
 
 
 
Investor Contact:
 
Media Contact:
Jennifer Zibuda
 
Pure Communications
Portola Pharmaceuticals
 
Portola_Media@purecommunications.com
IR@portola.com
 
 


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Grand Avenue South San Francisco CA 94080 650 246-7300 false false false false Common Stock PTLA NASDAQ false XML 16 R1.htm IDEA: XBRL DOCUMENT v3.19.3
Document and Entity Information Document
Nov. 05, 2019
Cover page.  
Document Type 8-K
Document Period End Date Nov. 05, 2019
Entity Registrant Name Portola Pharmaceuticals, Inc
Entity Incorporation, State or Country Code DE
Entity File Number 001-35935
Entity Tax Identification Number 20-0216859
Entity Address, Address Line One 270 E. Grand Avenue
Entity Address, City or Town South San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code 650
Local Phone Number 246-7300
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock
Trading Symbol PTLA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001269021
Amendment Flag false
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