Press Releases
Ionis exceeds 2018 financial guidance
"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
2018 Financial Results and Highlights
- Revenues increased by 17 percent compared to 2017
- Total revenue was
$600 million compared to$514 million in 2017. - Commercial revenue from SPINRAZA for 2018 was $238 million, more than double compared to 2017.
- 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. - 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.
- Total revenue was
- Achieved third consecutive year of non-GAAP operating profitability
- 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. - 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. - Operating expenses increased in 2018 primarily due to investment in the commercialization of TEGSEDI.
- GAAP operating income was
- Strong financial results trigger the recognition of a significant tax benefit
- 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. - 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.
- In 2018, Ionis reported GAAP net income attributable to Ionis common stockholders of
- 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 |
~$260 million to $290 million |
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
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
Business Highlights
- SPINRAZA – the worldwide standard-of-care for the treatment of all people with spinal muscular atrophy
- 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. - 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.
- 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.
- In 2018, SPINRAZA sales nearly doubled to
- TEGSEDI™ (inotersen) – launch underway in multiple markets for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
- TEGSEDI generated
$2.2 million in sales from the U.S. and EU in its first quarter of launch. PTC Therapeutics , Ionis and Akcea's commercialization partner inLatin America , filed for marketing authorization for TEGSEDI inBrazil and was granted priority review.
- TEGSEDI generated
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.
- Ongoing regulatory discussions on WAYLIVRA in the EU, and if approved, launch.
- Ionis and its partners plan to report data from numerous Phase 2 studies including IONIS-FXIRx, IONIS-HBVRx, and IONIS-GHR-LRx.
Revenue
Ionis' revenue in the three months and year ended
Three months ended, |
Year ended |
||||||||
December 31, |
December 31, |
||||||||
2018 |
2017 |
2018 |
2017 |
||||||
Revenue: |
(as revised) |
(as revised) |
|||||||
Commercial revenue: |
|||||||||
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 |
|||||
Milestone payments |
38 |
17 |
83 |
152 |
|||||
License fees |
38 |
51 |
102 |
116 |
|||||
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
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
Already in the first quarter of 2019, Ionis has earned
Operating Expenses
Operating expenses for the three months and year ended
Income Tax Benefit
Ionis reported an income tax benefit of $292 million and
Net Loss Attributable to Noncontrolling Interest in Akcea
At
Net Income (Loss) Attributable to Ionis Common Stockholders
Ionis reported net income attributable to Ionis' common stockholders of $320 million and
For the three months ended
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
Webcast and Conference Call
Today, at
About
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
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
In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to
IONIS PHARMACEUTICALS, INC. |
|||||||||||||
SELECTED FINANCIAL INFORMATION |
|||||||||||||
Condensed Consolidated Statements of Operations |
|||||||||||||
(In Thousands, Except Per Share Data) |
|||||||||||||
Three months ended, |
Year ended, |
||||||||||||
December 31, |
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, |
December 31, |
|||||
2018 |
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 |
||||||||
Ionis |
Akcea |
Eliminations |
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 |
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SOURCE
Ionis Pharmaceuticals Investor Contact: D. Wade Walke, Ph.D., Vice President, Investor Relations, 760-603-2741, OR Ionis Pharmaceuticals Media Contact: Roslyn Patterson, Vice President, Corporate Communications, 760-603-2681