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): February 27, 2019
IONIS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
|
000-19125
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33-0336973
|
|
|
(Commission File No.)
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(IRS Employer Identification No.)
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2855 Gazelle Court
Carlsbad, CA 92010
(Address of Principal Executive Offices and Zip Code)
Registrant’s telephone number, including area code: (760) 931-9200
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation 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)
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| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Section 230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Section 240.12b-2 of this chapter).
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Emerging growth company
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☐ |
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 February 27, 2019, Ionis Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter and
fiscal year ended December 31, 2018. In addition to disclosing results that are determined in accordance with Generally Accepted Accounting Principles (GAAP), the Company also discloses pro forma or non-GAAP results of operations, which are
adjusted from GAAP to exclude non-cash compensation related to stock awards. The Company is presenting pro forma information excluding non-cash compensation because the Company believes it is useful for investors in assessing the Company’s
operating results compared to the prior year. A copy of the release is furnished with this report as an exhibit pursuant to “Item 2.02. Results of Operations and Financial Condition” of Form 8-K in accordance with SEC Release Nos. 33-8216 and
34-47583.
The information in this Current Report on 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 (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 or the Exchange Act, regardless of any
general incorporation language in such filing.
| Item 9.01. |
Financial Statements and Exhibits.
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(d)
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Exhibits
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99.1
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Press Release dated February 27, 2019.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
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Ionis Pharmaceuticals, Inc.
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||
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Dated: February 27, 2019
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By:
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/s/ Patrick R. O’Neil
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Patrick R. O’Neil
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||
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Senior Vice President, Legal, General Counsel and Chief Compliance Officer
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INDEX TO EXHIBITS
| 99.1 |
Press Release dated February 27, 2019.
|
Exhibit 99.1
Ionis Exceeds 2018 Financial Guidance
Total revenue increased 17% compared to 2017 to $600 million
Commercial revenues more than doubled
Conference call and webcast today, February 27, 2019, at 11:30 a.m. Eastern Time
CARLSBAD, Calif., February 27, 2019 – Ionis Pharmaceuticals, Inc.
(Nasdaq: IONS) today reported financial results for the fourth quarter and full year 2018 and reviewed highlights of its successful year.
“We begin 2019 in the strongest position in our 30-year history. Building on this foundation, we believe we are positioned for continued growth,” said
Stanley T. Crooke, M.D., Ph.D., chairman of the board and chief executive officer of Ionis. “In 2018, we launched TEGSEDI globally through our affiliate, Akcea, adding revenue from TEGSEDI sales to our substantial commercial revenue from SPINRAZA.
We also achieved many important milestones in our pipeline, particularly among the medicines within our late-stage pipeline. This week, Novartis exercised its option to license
AKCEA-APO(a)-LRx for which we earned $150 million. Novartis plans to initiate a Phase 3 cardiovascular outcomes study and initiation activities are already underway. We and Akcea are finalizing Phase 3 study designs for the AKCEA-TTR-LRx
pivotal program that we plan to initiate in the second half of this year. In addition, our late-stage neurological disease programs recently achieved important milestones. Roche is now enrolling patients in the Phase 3 study of IONIS-HTTRx
for Huntington’s disease and Biogen is planning to add an additional cohort to the ongoing study of IONIS-SOD1Rx for patients with SOD1-related ALS that has the potential to support marketing approval. We achieved these
successes while growing revenues, investing in the commercialization of TEGSEDI, advancing our broad and diverse pipeline, and consistently leading our industry in innovation – demonstrating the success of our business model and robust technology
platform.”
2018 Financial Results and Highlights
| · |
Revenues increased by 17 percent compared to 2017
|
| o |
Total revenue was $600 million compared to $514 million in 2017.
|
| o |
Commercial revenue from SPINRAZA for 2018 was $238 million, more than double compared to 2017.
|
| o |
TEGSEDI sales were $2.2 million in the fourth quarter of 2018, with commercial sales commencing in the EU in October and in the U.S. in December.
|
| o |
Commercial revenue was over 40 percent of total revenue in 2018 compared to less than 25 percent in 2017, reflecting Ionis’ transition to a commercial-stage company.
|
| · |
Achieved third consecutive year of non-GAAP operating profitability
|
| o |
GAAP operating income was $11 million for the fourth quarter and an operating loss of $61 million for the full year 2018, compared to an operating loss of $6 million
and operating income of $31 million for the same periods in 2017.
|
| o |
Non-GAAP operating income was $45 million for the fourth quarter and $70 million for the full year 2018, compared to operating income of $16 million and $117 million
for the same periods in 2017.
|
| o |
Operating expenses increased in 2018 primarily due to investment in the commercialization of TEGSEDI.
|
| · |
Strong financial results trigger the recognition of a significant tax benefit
|
| o |
In 2018, Ionis reported GAAP net income attributable to Ionis common stockholders of $274 million, primarily driven by a $291 million one-time non-cash income tax benefit
Ionis recorded in 2018 related to its income tax assets.
|
| o |
Because of Ionis’ strong financial performance over the past few years and its outlook regarding the continued growth of its business, the Company believes it is more
likely than not that it will be able to use the significant amount of income tax assets it has accumulated to offset future taxable income.
|
| · |
Substantial cash position of over $2 billion enables continued investment in commercial
products and pipeline
|
2019 Financial Guidance
The Company’s full year 2019 financial guidance consists of the following components (on a non-GAAP basis):
|
Net income on a non-GAAP basis
|
|
|
Total Revenue
|
>$725 million
|
|
R&D Expenses
|
~$360 million to $390 million
|
|
SG&A Expenses
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~$260 million to $290 million
|
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Operating Income
|
>$100 million
|
|
Cash and Short-Term Investments
|
~$2 billion
|
“Building upon our success in 2018, we expect to continue our momentum this year and beyond. We anticipate both commercial and R&D revenues to
contribute to our overall earnings growth this year, potentially making 2019 our fourth consecutive year of non-GAAP operating profitability. And for the first time, due to our
strong financial performance in recent years and strong confidence in our future, we are projecting to be profitable on the bottom line on a non-GAAP basis in 2019. We believe our ability to be profitable while investing in commercial activities,
fully exploiting our pipeline and advancing our technology, clearly sets us apart from our peers,” said Elizabeth L. Hougen, chief financial officer of Ionis.
All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the
reconciliation of non-GAAP and GAAP measures, which is provided later in this release. In prior financial results releases, Ionis referred to amounts that excluded non-cash compensation expense related to equity awards as “pro forma”.
Additionally, Ionis has labeled its prior period financial statements “as revised” to reflect the revenue recognition accounting standard the Company adopted on January 1, 2018.
Business Highlights
| · |
SPINRAZA – the worldwide standard-of-care for the treatment of all people with
spinal muscular atrophy
|
| o |
In 2018, SPINRAZA sales nearly doubled to $1.7 billion compared to 2017, driven by growth in the U.S. and outside the U.S., as reported by Biogen.
|
| o |
As of the fourth quarter of 2018, more than 6,600 SMA patients from over 40 countries were on SPINRAZA, including commercial patients and patients in the expanded
access program and clinical trials.
|
| o |
In the fourth quarter of 2018, the number of adult patients on therapy in the U.S. grew by over 20 percent compared to the third quarter, accounting for more than 50
percent of new patient starts in the U.S.
|
| · |
TEGSEDI™ (inotersen) – launch underway in multiple markets for the treatment of
polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
|
| o |
TEGSEDI generated $2.2 million in sales from the U.S. and EU in its first quarter of launch.
|
| o |
PTC Therapeutics, Ionis and Akcea’s commercialization partner in Latin America, filed for marketing authorization for TEGSEDI in Brazil and was granted priority review.
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Key Upcoming Events
| · |
Roche plans to present data from the OLE study of IONIS-HTTRx in patients with Huntington’s disease in 2019.
|
| · |
Biogen plans to present data from the completed portions of the Phase 1/2 study of IONIS-SOD1Rx in 2019.
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| · |
Ongoing regulatory discussions on WAYLIVRA in the EU, and if approved, launch.
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| · |
Ionis and its partners plan to report data from numerous Phase 2 studies including IONIS-FXIRx, IONIS-HBVRx and IONIS-GHR-LRx.
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Revenue
Ionis’ revenue in the three months and year ended December 31, 2018 was $192 million and $600
million, respectively, compared to $168 million and $514 million for the same periods in 2017 and was comprised of the following (amounts in millions):
|
Three months ended,
December 31,
|
Year ended
December 31,
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|||||||||||||||
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2018
|
2017
|
2018
|
2017
|
|||||||||||||
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Revenue:
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(as revised)
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(as revised)
|
||||||||||||||
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Commercial revenue:
|
||||||||||||||||
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SPINRAZA royalties
|
$
|
70
|
$
|
52
|
$
|
238
|
$
|
113
|
||||||||
|
TEGSEDI product sales, net
|
2
|
-
|
2
|
-
|
||||||||||||
|
Licensing and royalty revenue
|
1
|
2
|
15
|
7
|
||||||||||||
|
Total commercial revenue
|
73
|
54
|
255
|
120
|
||||||||||||
|
R&D Revenue:
|
||||||||||||||||
|
Amortization from upfront payments
|
33
|
28
|
125
|
98
|
||||||||||||
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Milestone payments
|
38
|
17
|
83
|
152
|
||||||||||||
|
License fees
|
38
|
51
|
102
|
116
|
||||||||||||
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Other services
|
10
|
18
|
35
|
28
|
||||||||||||
|
Total R&D revenue
|
119
|
114
|
345
|
394
|
||||||||||||
|
Total revenue
|
$
|
192
|
$
|
168
|
$
|
600
|
$
|
514
|
||||||||
The increase in revenue in 2018 compared to 2017 was primarily due to increasing commercial revenue from SPINRAZA royalties, which more than doubled.
Additionally, Ionis earned more than $2 million from TEGSEDI product sales in the fourth quarter of 2018.
Ionis’ R&D revenue demonstrates the Company’s ability to generate sustainable revenue from its numerous partnerships. R&D revenue from the
amortization of upfront payments increased over $25 million in 2018 compared to 2017. The increase in amortization was primarily due to Ionis’ 2018 strategic neurology collaboration with Biogen. Also, in 2018, Ionis added amortization revenue
from its new collaboration with Roche to develop IONIS-FB-LRx. Ionis’ R&D revenue from milestone payments, license fees and other services for 2018 continued to make a significant contribution to Ionis’ financial results.
Already in the first quarter of 2019, Ionis has earned $185 million. The Company earned $150 million from Novartis when it licensed AKCEA-APO(a)-LRx
and $35 million from Roche when it enrolled the first patient in the Phase 3 study of IONIS-HTTRx in patients with Huntington’s disease.
Operating Expenses
Operating expenses for the three months and year ended December 31, 2018 on a GAAP basis were $181 million and $661 million, respectively, and on a
non-GAAP basis were $147 million and $530 million, respectively. These amounts compare to GAAP operating expenses for the three months and year ended December 31, 2017 of $174
million and $483 million, respectively, and non-GAAP operating expenses of $152 million and $397 million, respectively. The full year increase in operating expenses in 2018 compared to 2017 was principally due to Ionis’ investments in the global
launch of TEGSEDI. The Company’s SG&A expenses also increased due to an increase in fees the Company owed under its in-licensing agreements related to SPINRAZA, due to increased SPINRAZA product sales.
Income Tax Benefit
Ionis reported an income tax benefit of $292 million and $291 million for the three months and year ended December 31, 2018, respectively, compared to $7
million and $6 million for the same periods in 2017. Ionis’ tax benefit increased significantly in 2018 primarily due to a one-time non-cash tax benefit related to its deferred income tax assets. In the fourth quarter of 2018, the Company
released a large portion of the valuation allowance associated with its deferred tax assets. Because of Ionis’ strong financial performance over the past few years and its outlook regarding the continued growth of its business, the Company
determined that it is more likely than not that it will be able to utilize most of the deferred income tax assets it has accumulated to offset future taxable income.
Net Loss Attributable to Noncontrolling Interest in Akcea
At December 31, 2018, Ionis owned approximately 75 percent of Akcea. The shares of
Akcea third parties own represent an interest in Akcea’s equity that Ionis does not control. However, because Ionis continues to maintain overall control of Akcea through its voting interest, Ionis reflects the assets, liabilities and results of
operations of Akcea in Ionis’ consolidated financial statements. Ionis reflects the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line called “Net loss attributable to noncontrolling interest in Akcea”
on Ionis’ statement of operations. Ionis’ net loss attributable to noncontrolling interest in Akcea for the three months and year ended December 31, 2018, was $17 million and $59 million, respectively. Ionis’ net loss attributable to
noncontrolling interest in Akcea for the three months and year ended December 31, 2017, was $6 million and $11 million, respectively.
Net Income (Loss) Attributable to Ionis Common Stockholders
Ionis reported net income attributable to Ionis’ common stockholders of $320 million and $274 million for the three months and year ended December 31,
2018, respectively, compared to a net loss of $3 million and net income of $0.3 million for the same periods in 2017, all on a GAAP basis. On a non-GAAP basis, Ionis reported net income attributable to Ionis’ common stockholders of $351 million
and $394 million for the three months and year ended December 31, 2018, respectively, compared to $18 million and $85 million for the same periods in 2017. The increase in 2018 net income attributable to Ionis’ common stockholders was primarily
due to increases in revenue and the income tax benefit Ionis recognized in the fourth quarter of 2018.
For the three months ended December 31, 2018, basic and diluted net income per share were $2.32 and $2.21, respectively. For the year ended December 31,
2018, basic and diluted net income per share were $2.09 and $2.07, respectively. For the three months ended December 31, 2017, basic and diluted net loss per share were each
$0.03. For the year ended December 31, 2017, basic and diluted net income per share were each $0.15. All
amounts are on a GAAP basis.
Balance Sheet
As of December 31, 2018, Ionis had cash, cash equivalents and short-term investments of $2.1 billion compared to $1.0 billion at December 31, 2017. The
increase in Ionis’ cash, cash equivalents and short-term investments was primarily due to the $1 billion Ionis received from Biogen for the 2018 strategic neurology collaboration.
Webcast and Conference Call
Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast conference call to discuss this earnings release and related activities. Interested
parties may listen to the call by dialing 877-443-5662 or access the webcast at www.ionispharma.com. A webcast replay will be available for a limited time.
About Ionis Pharmaceuticals, Inc.
As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, proprietary antisense technology
platform with the potential to treat diseases where no other therapeutic approaches have proven effective. Our drug discovery platform has served as a springboard for actionable promise and realized hope for patients with unmet needs – such as
children and adults with spinal muscular atrophy (SMA). We created SPINRAZA® (nusinersen)* and are proud to have brought new hope to the SMA community by developing the first and only approved treatment for this disease.
Our sights are set on all the patients we have yet to reach with a pipeline of more than 40 medicines with the potential to treat patients with
cardiovascular disease, rare diseases, neurological diseases, infectious diseases and cancer. We created TEGSEDI™ (inotersen) the world’s first RNA-targeted therapeutic approved for the treatment of polyneuropathy of hereditary transthyretin
(TTR) amyloidosis (ATTR) in adult patients that our affiliate Akcea Therapeutics is commercializing. Together with Akcea, we are also bringing new medicines to patients with cardiometabolic lipid disorders.
To learn more about Ionis follow us on twitter @ionispharma or visit http://ir.ionispharma.com/.
*Spinraza is marketed by Biogen.
Ionis’ Forward-looking Statement
This press release includes forward-looking statements regarding Ionis’ business, financial guidance and the therapeutic and commercial potential of
SPINRAZA (nusinersen) and TEGSEDI (inotersen) and Ionis’ technologies and products in development, including the business of Akcea Therapeutics, Inc., Ionis’ majority-owned
affiliate. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and
uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Ionis’
forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking
statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks
concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2017, and most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of these and other
documents are available from the Company.
Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics™ is a trademark of Akcea Therapeutics, Inc.
TEGSEDI™ is a trademark of Akcea Therapeutics, Inc. WAYLIVRA™ is a trademark of Akcea Therapeutics, Inc. SPINRAZA® is a registered trademark of Biogen.
Ionis Pharmaceuticals Investor Contact:
D. Wade Walke, Ph.D.
Vice President, Investor Relations
760-603-2741
Ionis Pharmaceuticals Media Contact:
Roslyn Patterson
Vice President, Corporate Communications
760-603-2681
IONIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
Condensed Consolidated Statements of Operations
(In Thousands, Except Per Share Data)
|
Three months ended,
December 31,
|
Year ended,
December 31,
|
|||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
|||||||||||||
|
(as revised)
|
(as revised)
|
|||||||||||||||
| (unaudited) |
||||||||||||||||
|
Revenue:
|
||||||||||||||||
|
Commercial revenue:
|
||||||||||||||||
|
SPINRAZA royalties
|
$
|
70,187
|
$
|
52,073
|
$
|
237,930
|
$
|
112,540
|
||||||||
|
TEGSEDI product sales, net
|
2,237
|
-
|
2,237
|
-
|
||||||||||||
|
Licensing and royalty revenue
|
523
|
1,835
|
14,755
|
7,474
|
||||||||||||
|
Total commercial revenue
|
72,947
|
53,908
|
254,922
|
120,014
|
||||||||||||
|
Research and development revenue under collaborative agreements
|
119,166
|
113,883
|
344,752
|
394,165
|
||||||||||||
|
Total revenue
|
192,113
|
167,792
|
599,674
|
514,179
|
||||||||||||
|
Expenses:
|
||||||||||||||||
|
Cost of products sold
|
777
|
-
|
1,820
|
-
|
||||||||||||
|
Research, development and patent
|
113,451
|
128,285
|
414,604
|
374,644
|
||||||||||||
|
Selling, general and administrative
|
67,103
|
45,707
|
244,622
|
108,488
|
||||||||||||
|
Total operating expenses
|
181,331
|
173,992
|
661,046
|
483,132
|
||||||||||||
|
Income (loss) from operations
|
10,782
|
(6,200
|
)
|
(61,372
|
)
|
31,047
|
||||||||||
|
Other income (expense):
|
||||||||||||||||
|
Investment income
|
11,484
|
673
|
30,187
|
8,179
|
||||||||||||
|
Interest expense
|
(11,458
|
)
|
(10,787
|
)
|
(44,789
|
)
|
(44,752
|
)
|
||||||||
|
Loss on debt financing liability for leased facility
|
-
|
-
|
-
|
(7,689
|
)
|
|||||||||||
|
Other expenses
|
(37
|
)
|
(19
|
)
|
(182
|
)
|
(3,548
|
)
|
||||||||
|
Income (loss) before income tax benefit
|
10,771
|
(16,333
|
)
|
(76,156
|
)
|
(16,763
|
)
|
|||||||||
|
Income tax benefit
|
291,964
|
7,164
|
291,141
|
5,980
|
||||||||||||
|
Net income (loss)
|
$
|
302,735
|
$
|
(9,169
|
)
|
$
|
214,985
|
$
|
(10,783
|
)
|
||||||
|
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc.
|
17,343
|
6,247
|
58,756
|
11,129
|
||||||||||||
|
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
320,078
|
$
|
(2,922
|
)
|
$
|
273,741
|
$
|
346
|
|||||||
|
Basic net income (loss) per share
|
$
|
2.32
|
$
|
(0.03
|
)
|
$
|
2.09
|
$
|
0.15
|
|||||||
|
Diluted net income (loss) per share
|
$
|
2.21
|
$
|
(0.03
|
)
|
$
|
2.07
|
$
|
0.15
|
|||||||
|
Shares used in computing basic net income (loss) per share
|
137,699
|
124,818
|
132,320
|
124,016
|
||||||||||||
|
Shares used in computing diluted net income (loss) per share
|
149,856
|
124,818
|
134,056
|
126,098
|
||||||||||||
IONIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
Condensed Consolidating Statement of Operations
(In Thousands)
|
Year Ended,
December 31, 2018
|
||||||||||||||||
|
Ionis
|
Akcea
|
Eliminations
|
Ionis
Consolidated
|
|||||||||||||
|
Revenue:
|
||||||||||||||||
|
Commercial revenue:
|
||||||||||||||||
|
SPINRAZA royalties
|
$
|
237,930
|
$
|
-
|
$
|
-
|
$
|
237,930
|
||||||||
|
TEGSEDI product sales, net
|
-
|
2,237
|
-
|
2,237
|
||||||||||||
|
Licensing and royalty revenue
|
2,755
|
12,000
|
-
|
14,755
|
||||||||||||
|
Total commercial revenue
|
240,685
|
14,237
|
-
|
254,922
|
||||||||||||
|
Research and development revenue under collaborative agreements
|
294,122
|
50,630
|
-
|
344,752
|
||||||||||||
|
Intercompany revenue
|
107,137
|
-
|
(107,137
|
)
|
-
|
|||||||||||
|
Total revenue
|
641,944
|
64,867
|
(107,137
|
)
|
599,674
|
|||||||||||
|
Expenses:
|
||||||||||||||||
|
Cost of products sold
|
-
|
11,733
|
(9,913
|
)
|
1,820
|
|||||||||||
|
Research, development and patent expenses
|
289,650
|
130,340
|
(5,386
|
)
|
414,604
|
|||||||||||
|
Selling, general and administrative
|
90,562
|
153,610
|
450
|
244,622
|
||||||||||||
|
Total operating expenses
|
380,212
|
295,683
|
(14,849
|
)
|
661,046
|
|||||||||||
|
Income (loss) from operations
|
261,732
|
(230,816
|
)
|
(92,288
|
)
|
(61,372
|
)
|
|||||||||
|
Other income (expense):
|
||||||||||||||||
|
Investment income
|
24,563
|
5,624
|
-
|
30,187
|
||||||||||||
|
Interest expense
|
(44,789
|
)
|
-
|
-
|
(44,789
|
)
|
||||||||||
|
Other expenses
|
-
|
(182
|
)
|
-
|
(182
|
)
|
||||||||||
|
Income (loss) before income tax expense
|
241,506
|
(225,374
|
)
|
(92,288
|
)
|
(76,156
|
)
|
|||||||||
|
Income tax (expense) benefit
|
291,588
|
(447
|
)
|
-
|
291,141
|
|||||||||||
|
Net income (loss)
|
$
|
533,094
|
$
|
(225,821
|
)
|
$
|
(92,288
|
)
|
$
|
214,985
|
||||||
|
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc.
|
$
|
-
|
$
|
-
|
$
|
58,756
|
$
|
58,756
|
||||||||
|
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
533,094
|
$
|
(225,821
|
)
|
$
|
(33,532
|
)
|
$
|
273,741
|
||||||
IONIS PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Basis:
Condensed Consolidated Operating Expenses, Income (Loss) From Operations, and Net Income (Loss)
(In Thousands)
|
Three months ended,
December 31,
|
Year ended,
December 31,
|
|||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
|||||||||||||
|
(as revised)
|
(as revised)
|
|||||||||||||||
|
(unaudited)
|
||||||||||||||||
|
As reported research, development and patent expenses according to GAAP
|
$
|
113,451
|
$
|
128,285
|
$
|
414,604
|
$
|
374,644
|
||||||||
|
Excluding compensation expense related to equity awards
|
(18,860
|
)
|
(16,078
|
)
|
(76,557
|
)
|
(64,521
|
)
|
||||||||
|
Non-GAAP research, development and patent expenses
|
$
|
94,591
|
$
|
112,207
|
$
|
338,047
|
$
|
310,123
|
||||||||
|
As reported selling, general and administrative expenses according to GAAP
|
$
|
67,103
|
$
|
45,707
|
$
|
244,622
|
$
|
108,488
|
||||||||
|
Excluding compensation expense related to equity awards
|
(15,083
|
)
|
(6,255
|
)
|
(54,595
|
)
|
(21,454
|
)
|
||||||||
|
Non-GAAP selling, general and administrative expenses
|
$
|
52,020
|
$
|
39,452
|
$
|
190,027
|
$
|
87,034
|
||||||||
|
As reported operating expenses according to GAAP
|
$
|
181,331
|
$
|
173,992
|
$
|
661,046
|
$
|
483,132
|
||||||||
|
Excluding compensation expense related to equity awards
|
(34,103
|
)
|
(22,333
|
)
|
(131,312
|
)
|
(85,975
|
)
|
||||||||
|
Non-GAAP operating expenses
|
$
|
147,228
|
$
|
151,659
|
$
|
529,734
|
$
|
397,157
|
||||||||
|
As reported income (loss) from operations according to GAAP
|
$
|
10,782
|
$
|
(6,200
|
)
|
$
|
(61,372
|
)
|
$
|
31,047
|
||||||
|
Excluding compensation expense related to equity awards
|
(34,103
|
)
|
(22,333
|
)
|
(131,312
|
)
|
(85,975
|
)
|
||||||||
|
Non-GAAP income from operations
|
$
|
44,885
|
$
|
16,133
|
$
|
69,940
|
$
|
117,022
|
||||||||
|
As reported net income (loss) attributable to Ionis Pharmaceuticals, Inc. common
stockholders according to GAAP
|
$
|
320,078
|
$
|
(2,922
|
)
|
$
|
273,741
|
$
|
346
|
|||||||
|
Excluding compensation expense related to equity awards attributable to Ionis Pharmaceuticals, Inc. common
stockholders
|
(30,897
|
)
|
(20,518
|
)
|
(119,790
|
)
|
(84,369
|
)
|
||||||||
|
Non-GAAP net income attributable to Ionis Pharmaceuticals, Inc. common stockholders
according to GAAP
|
$
|
350,975
|
$
|
17,596
|
$
|
393,531
|
$
|
84,715
|
||||||||
Reconciliation of GAAP to Non-GAAP Basis
As illustrated in the Selected Financial Information in this press release, non-GAAP operating expenses, non-GAAP income (loss) from operations, and
non-GAAP net income (loss) were adjusted from GAAP to exclude compensation expense related to equity awards, which are non-cash. Ionis has regularly reported non-GAAP measures for operating results as non-GAAP results. These measures are provided
as supplementary information and are not a substitute for financial measures calculated in accordance with GAAP. Ionis reports these non-GAAP results to better enable financial statement users to assess and compare its historical performance and
project its future operating results and cash flows. Further, the presentation of Ionis’ non-GAAP results is consistent with how Ionis’ management internally evaluates the performance of its operations. In prior financial results releases, Ionis
referred to amounts that excluded non-cash compensation expense related to equity awards as “pro forma”.
IONIS PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(In Thousands)
|
December 31,
2018
|
December 31,
2017
|
|||||||
|
(as revised)
|
||||||||
|
Assets:
|
||||||||
|
Cash, cash equivalents and short-term investments
|
$
|
2,084,072
|
$
|
1,022,715
|
||||
|
Contracts receivable
|
12,759
|
62,955
|
||||||
|
Other current assets
|
111,055
|
83,064
|
||||||
|
Property, plant and equipment, net
|
132,160
|
121,907
|
||||||
|
Other assets
|
327,738
|
32,133
|
||||||
|
Total assets
|
$
|
2,667,784
|
$
|
1,322,774
|
||||
|
Liabilities and stockholders’ equity:
|
||||||||
|
Other current liabilities
|
$
|
120,038
|
$
|
118,276
|
||||
|
Current portion of deferred contract revenue
|
160,256
|
125,336
|
||||||
|
1% convertible senior notes
|
568,215
|
533,111
|
||||||
|
Long-term obligations, less current portion
|
64,756
|
72,745
|
||||||
|
Long-term deferred contract revenue
|
567,359
|
108,026
|
||||||
|
Total Ionis stockholders’ equity
|
1,048,079
|
281,013
|
||||||
|
Noncontrolling interest in Akcea Therapeutics, Inc.
|
139,081
|
84,267
|
||||||
|
Total stockholders’ equity
|
1,187,160
|
365,280
|
||||||
|
Total liabilities and stockholders’ equity
|
$
|
2,667,784
|
$
|
1,322,774
|
||||
IONIS PHARMACEUTICALS, INC.
Condensed Consolidating Balance Sheet
(In Thousands)
|
December 31, 2018
|
||||||||||||||||
|
Ionis
|
Akcea
|
Eliminations
|
Ionis
Consolidated
|
|||||||||||||
|
Assets:
|
||||||||||||||||
|
Cash, cash equivalents and short-term investments
|
$
|
1,831,463
|
$
|
252,609
|
$
|
-
|
$
|
2,084,072
|
||||||||
|
Contracts receivable
|
10,763
|
1,996
|
-
|
12,759
|
||||||||||||
|
Receivable from Akcea Therapeutics, Inc.
|
18,901
|
-
|
(18,901
|
)
|
-
|
|||||||||||
|
Other current assets
|
102,613
|
12,630
|
(4,188
|
)
|
111,055
|
|||||||||||
|
Property, plant and equipment, net
|
126,464
|
5,696
|
-
|
132,160
|
||||||||||||
|
Other assets
|
885,288
|
92,330
|
(649,880
|
)
|
327,738
|
|||||||||||
|
Total assets
|
$
|
2,975,492
|
$
|
365,261
|
$
|
(672,969
|
)
|
$
|
2,667,784
|
|||||||
|
Liabilities and stockholders’ equity:
|
||||||||||||||||
|
Other current liabilities
|
$
|
87,820
|
$
|
55,307
|
$
|
(23,089
|
)
|
$
|
120,038
|
|||||||
|
Current portion of deferred contract revenue
|
134,902
|
25,354
|
-
|
160,256
|
||||||||||||
|
1% convertible senior notes
|
568,215
|
-
|
-
|
568,215
|
||||||||||||
|
Long-term obligations, less current portion
|
60,314
|
4,442
|
-
|
64,756
|
||||||||||||
|
Long-term deferred contract revenue
|
565,624
|
3,434
|
(1,699
|
)
|
567,359
|
|||||||||||
|
Total stockholders’ equity before noncontrolling interest
|
1,558,617
|
276,724
|
(787,262
|
)
|
1,048,079
|
|||||||||||
|
Noncontrolling interest in Akcea Therapeutics, Inc.
|
-
|
-
|
139,081
|
139,081
|
||||||||||||
|
Total stockholders’ equity
|
1,558,617
|
276,724
|
(648,181
|
)
|
1,187,160
|
|||||||||||
|
Total liabilities and stockholders’ equity
|
$
|
2,975,492
|
$
|
365,261
|
$
|
(672,969
|
)
|
$
|
2,667,784
|
|||||||