Press Releases
Ionis Reports Second Quarter 2019 Financial Results
"We enter the second half of 2019 in a position of substantial financial strength driven by revenue growth of more than 75 percent. SPINRAZA's blockbuster performance, with over
"Our strong year-to-date financial results were driven by continued revenue growth across both commercial and R&D revenues. These results put us on track to meet or potentially improve upon our 2019 guidance. We are also on track to achieve our fourth consecutive year of operating income and our third consecutive year of net income, both on a non-GAAP basis. 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
Year-to-Date 2019 Financial Results and Highlights
- Year-to-date revenues increased more than 75 percent
- Commercial revenue from SPINRAZA® (nusinersen) royalties increased more than 30 percent to
$130 million for the first half of 2019 compared to 2018. - TEGSEDI® (inotersen) product sales were
$17 million in the first half of 2019, reflecting a more than 40 percent increase in the second quarter compared to the first quarter. - R&D revenue nearly doubled in the first half of 2019 compared to 2018.
- Significant net income for the first half of 2019 puts Ionis on track for its third consecutive year of net income
- Operating income and net income significantly improved to
$103 million and$84 million , respectively, in the first half of 2019 compared to 2018. - Non-GAAP operating income increased by more than 20-fold in the first half of 2019 compared to 2018.
- Non-GAAP net income increased by approximately 10-fold in the first half of 2019 compared to 2018.
- Maintained substantial cash position of
$2.3 billion while aggressively investing broadly across Ionis' business
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 addition to our commercial medicines, we have a broad and advancing pipeline of potentially transformational medicines we are moving toward the market. In our late-stage pipeline, our medicines targeting Huntington's disease and SOD1-ALS are progressing in Phase 3 studies, both with the potential to support registration. Our LICA medicines targeting Lp(a)-driven cardiovascular disease and TTR amyloidosis are on track to initiate Phase 3 programs this year. Positive results from our HBV program, our advancing FXI program, which is nearing completion, and the initiation of multiple Phase 2 studies demonstrate the potential value in our mid-stage pipeline. All of these potentially transformational medicines demonstrate the ability of our technology to address a broad range of diseases from rare diseases to those affecting millions of patients," said
Recent Business Highlights
- SPINRAZA – a worldwide foundation-of-care for the treatment of patients of all ages with spinal muscular atrophy (SMA)
- Worldwide sales of SPINRAZA increased by nearly 30 percent to
$1 billion in the first half of 2019 compared to 2018. - Patients on SPINRAZA treatment increased by approximately 12 percent, compared to last quarter, to approximately 8,400 patients across global commercial, clinical and expanded access settings.
- Biogen believes the global SMA opportunity to be significantly greater than previous estimates, with over 45,000 patients in markets where Biogen has a direct presence.
- TEGSEDI – launch underway in multiple markets for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
- Product sales were
$17 million in the first half of 2019 and$10 million in the second quarter of 2019. - On track to launch in
England this month following a positive reimbursement recommendation from NICE. - Launch in additional EU countries planned; launch in
Latin America planned withPTC Therapeutics . - WAYLIVRA® (volanesorsen) – the only medicine approved in the EU for the treatment of adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis
- On track to launch in the EU this month, beginning in
Germany , with additional EU country launches planned in 2020. - Encouraging discussions continued with the
U.S. Food and Drug Administration to clarify a path forward in the U.S. - Received
$6 million milestone payment fromPTC Therapeutics for the EU approval of WAYLIVRA in the second quarter. - Achieved the primary endpoint of a statistically significant reduction in triglyceride levels and an important secondary endpoint of a statistically significant reduction in liver fat with good safety and tolerability in patients with familial partial lipodystrophy (FPL) in the BROADEN study.
- Ionis achieved positive results in its program to treat patients with hepatitis B viral infection as reported by GSK.
- Ionis initiated a Phase 2 study of IONIS-FB-LRx in patients with geographic atrophy secondary to age-related macular degeneration.
- Ionis initiated a Phase 2 study of IONIS-PKK-LRx in patients with hereditary angioedema.
- Ionis appointed
Joan E. Herman , MBA, MS, president and chief executive officer ofHerman and Associates, LLC to the Ionis board of directors.
Key Upcoming Events
- Ionis and Akcea plan to initiate the Phase 3 program for AKCEA-TTR-LRx in patients with TTR amyloidosis before the end of 2019.
Novartis plans to initiate the Phase 3 HORIZON cardiovascular outcomes study of AKCEA-APO(a)-LRx (TQJ230) in patients with elevated Lp(a)-driven cardiovascular disease before the end of 2019.- Ionis and Akcea plan to present data from the Phase 1/2 study of AKCEA-TTR-LRx in healthy volunteers in
September 2019 at the European ATTR Amyloidosis meeting and at theHeart Failure Society of America . Roche plans to present data from the open label extension portion of the Phase 1/2 study of IONIS-HTTRx (RG6042) in patients with Huntington's disease.- Ionis plans to initiate a Phase 2 study of IONIS-FB-LRx in a second indication under Ionis' collaboration with
Roche to develop medicines for the treatment of complement-mediated diseases. - Ionis and its partners plan to report data from the HBV and FXI clinical programs at future medical conferences.
- Ionis and Akcea plan to report top line results from Phase 2 studies of AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx in 1H 2020.
Revenue
Ionis' revenue in the three and six months ended
Three months ended, |
Six months ended |
|||||||
June 30, |
June 30, |
|||||||
2019 |
2018 |
2019 |
2018 |
|||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$71 |
$57 |
$130 |
$98 |
||||
TEGSEDI product sales, net |
10 |
- |
17 |
- |
||||
Licensing and royalty revenue |
7 |
- |
9 |
1 |
||||
Total commercial revenue |
88 |
57 |
156 |
99 |
||||
R&D Revenue: |
||||||||
Amortization from upfront payments |
41 |
34 |
75 |
61 |
||||
Milestone payments |
12 |
12 |
52 |
18 |
||||
License fees |
22 |
1 |
173 |
63 |
||||
Other services |
1 |
14 |
5 |
21 |
||||
Total R&D revenue |
76 |
61 |
305 |
163 |
||||
Total revenue |
$164 |
$118 |
$461 |
$262 |
For the first half of 2019, Ionis significantly increased both commercial revenue and R&D revenue compared to the same period in 2018. Commercial revenue from SPINPRAZA royalties increased over 30 percent primarily due to increased SPINRAZA product sales. TEGSEDI product sales increased more than 40 percent over the first quarter of this year and were another important source of commercial revenue for Ionis.
Ionis' R&D revenue substantially increased in the first half of 2019 compared to the same period in 2018 primarily due to the following:
$150 million the Company earned fromNovartis whenNovartis licensed AKCEA-APO(a)-LRx;$35 million the Company earned fromRoche whenRoche enrolled the first patient in the Phase 3 study of IONIS-HTTRx in patients with Huntington's disease; and$20 million the Company earned from Alnylam when Alnylam licensed Ionis' technology to Regeneron.
Operating Expenses
Operating expenses for the three and six months ended
Income Tax Expense
Ionis recorded an income tax benefit of
Net Loss Attributable to Noncontrolling Interest in Akcea
At
Net Income (Loss) Attributable to Ionis Common Stockholders
On a GAAP basis, Ionis reported net loss and net income attributable to Ionis' common stockholders of $1 million and
For the three months ended
Balance Sheet
Ionis maintained its strong balance sheet, ending the second quarter of 2019 with cash, cash equivalents and short-term investments of $2.3 billion, compared to
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Today, at
About
As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can 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. We created the first and only approved treatment for children and adults with spinal muscular atrophy as well as the world's first RNA-targeted therapeutic approved for the treatment of polyneuropathy in adults with hereditary transthyretin amyloidosis. Our sights are set on all the patients we have yet to reach with a pipeline of more than 40 novel medicines designed to treat a broad range of diseases including cardiovascular diseases, neurological diseases, infectious diseases, pulmonary diseases and cancer.
To learn more about Ionis visit www.ionispharma.com or follow us on twitter @ionispharma.
*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), TEGSEDI (inotersen) and WAYLIVRA (volanesorsen) 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 Millions, Except Per Share Data) |
||||||||
Three months ended, |
Six months ended, |
|||||||
June 30, |
June 30, |
|||||||
2019 |
2018 |
2019 |
2018 |
|||||
(unaudited) |
||||||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$71 |
$57 |
$130 |
$98 |
||||
TEGSEDI product sales, net |
10 |
- |
17 |
- |
||||
Licensing and royalty revenue |
7 |
- |
9 |
1 |
||||
Total commercial revenue |
88 |
57 |
156 |
99 |
||||
Research and development revenue under collaborative agreements |
76 |
61 |
305 |
163 |
||||
Total revenue |
164 |
118 |
461 |
262 |
||||
Expenses: |
||||||||
Cost of products sold |
1 |
- |
2 |
- |
||||
Research, development and patent |
106 |
102 |
213 |
206 |
||||
Selling, general and administrative |
76 |
66 |
143 |
110 |
||||
Total operating expenses |
183 |
168 |
358 |
316 |
||||
Income (loss) from operations |
(19) |
(50) |
103 |
(54) |
||||
Other income (expense): |
||||||||
Investment income |
14 |
5 |
25 |
9 |
||||
Interest expense |
(12) |
(11) |
(23) |
(22) |
||||
Income (loss) before income tax benefit (expense) |
(17) |
(56) |
105 |
(67) |
||||
Income tax benefit (expense) |
7 |
- - |
(24) |
- |
||||
Net income (loss) |
$(10) |
$(56) |
$81 |
$(67) |
||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
9 |
16 |
3 |
25 |
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$(1) |
$(40) |
$84 |
$(42) |
||||
Basic net income (loss) per share |
$(0.01) |
$(0.29) |
$0.62 |
$(0.30) |
||||
Diluted net income (loss) per share |
$(0.01) |
$(0.29) |
$0.61 |
$(0.30) |
||||
Shares used in computing basic net income (loss) per share |
140 |
129 |
139 |
127 |
||||
Shares used in computing diluted net income (loss) per share |
140 |
129 |
142 |
127 |
IONIS PHARMACEUTICALS, INC. |
||||||||
SELECTED FINANCIAL INFORMATION |
||||||||
Condensed Consolidating Statement of Operations |
||||||||
(In Millions) |
||||||||
Six months ended, |
||||||||
June 30, 2019 |
||||||||
(unaudited) |
||||||||
Ionis |
Akcea |
Eliminations |
Ionis Consolidated |
|||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$130 |
$ - |
$ - |
$130 |
||||
TEGSEDI product sales, net |
- |
17 |
- |
17 |
||||
Licensing and royalty revenue |
4 |
5 |
- |
9 |
||||
Total commercial revenue |
134 |
22 |
- |
156 |
||||
Research and development revenue under collaborative agreements |
137 |
168 |
- |
305 |
||||
Intercompany revenue |
91 |
- |
(91) |
- |
||||
Total revenue |
362 |
190 |
(91) |
461 |
||||
Expenses: |
||||||||
Cost of products sold |
- |
8 |
(6) |
2 |
||||
Research, development and patent expenses |
168 |
120 |
(75) |
213 |
||||
Selling, general and administrative |
48 |
95 |
- |
143 |
||||
Profit/ loss share for TEGSEDI commercialization activities |
20 |
(20) |
- |
- |
||||
Total operating expenses |
236 |
203 |
(81) |
358 |
||||
Income (loss) from operations |
126 |
(13) |
(10) |
103 |
||||
Other income (expense): |
||||||||
Investment income |
22 |
3 |
- |
25 |
||||
Interest expense |
(23) |
- |
- |
(23) |
||||
Income before income tax expense |
125 |
(10) |
(10) |
105 |
||||
Income tax expense |
(24) |
- |
- |
(24) |
||||
Net income (loss) |
$101 |
$(10) |
$(10) |
$81 |
||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
3 |
3 |
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$101 |
$(10) |
$(7) |
$84 |
IONIS PHARMACEUTICALS, INC. |
|||||||||
Reconciliation of GAAP to Non-GAAP Basis: |
|||||||||
Condensed Consolidated Operating Expenses, Income (Loss) From Operations, and Net Income (Loss) |
|||||||||
(In Millions) |
|||||||||
Three months ended, June 30, |
Six months ended, June 30, |
||||||||
2019 |
2018 |
2019 |
2018 |
||||||
(unaudited) |
|||||||||
As reported research, development and patent expenses according to GAAP |
$106 |
$102 |
$213 |
$206 |
|||||
Excluding compensation expense related to equity awards |
(24) |
(19) |
(49) |
(39) |
|||||
Non-GAAP research, development and patent expenses |
$82 |
$83 |
$164 |
$167 |
|||||
As reported selling, general and administrative expenses according to GAAP |
76 |
66 |
143 |
110 |
|||||
Excluding compensation expense related to equity awards |
(18) |
(14) |
(39) |
(24) |
|||||
Non-GAAP selling, general and administrative expenses |
$58 |
$52 |
$104 |
$86 |
|||||
As reported operating expenses according to GAAP |
$183 |
$168 |
$358 |
$316 |
|||||
Excluding compensation expense related to equity awards |
(42) |
(34) |
(87) |
(63) |
|||||
Non-GAAP operating expenses |
$141 |
$134 |
$271 |
$253 |
|||||
As reported income (loss) from operations according to GAAP |
$(19) |
$(50) |
$103 |
$(54) |
|||||
Excluding compensation expense related to equity awards |
(42) |
(34) |
(87) |
(63) |
|||||
Non-GAAP income (loss) from operations |
$23 |
$(16) |
$190 |
$9 |
|||||
As reported net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$(1) |
$(40) |
$84 |
$(42) |
|||||
Excluding compensation expense related to equity awards attributable to Ionis Pharmaceuticals, Inc. common stockholders |
(39) |
(30) |
(78) |
(57) |
|||||
Non-GAAP net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$38 |
$(10) |
$162 |
$15 |
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.
IONIS PHARMACEUTICALS, INC. |
||||||
Condensed Consolidated Balance Sheets |
||||||
(In Millions) |
||||||
June 30, |
December 31, |
|||||
2019 |
2018 |
|||||
(unaudited) |
||||||
Assets: |
||||||
Cash, cash equivalents and short-term investments |
$2,262 |
$2,084 |
||||
Contracts receivable |
32 |
13 |
||||
Other current assets |
121 |
111 |
||||
Property, plant and equipment, net |
135 |
132 |
||||
Other assets |
328 |
328 |
||||
Total assets |
$2,878 |
$2,668 |
||||
Liabilities and stockholders' equity: |
||||||
Other current liabilities |
$ 104 |
$ 120 |
||||
Current portion of deferred contract revenue |
137 |
160 |
||||
1% convertible senior notes |
587 |
568 |
||||
Long-term obligations, less current portion |
76 |
65 |
||||
Long-term deferred contract revenue |
517 |
567 |
||||
Total Ionis stockholders' equity |
1,269 |
1,049 |
||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
188 |
139 |
||||
Total stockholders' equity |
1,457 |
1,188 |
||||
Total liabilities and stockholders' equity |
$2,878 |
$2,668 |
||||
IONIS PHARMACEUTICALS, INC. |
||||||||
Condensed Consolidating Balance Sheet |
||||||||
(In Millions) |
||||||||
June 30, 2019 |
||||||||
(unaudited) |
||||||||
Ionis |
||||||||
Ionis |
Akcea |
Eliminations |
Consolidated |
|||||
Assets: |
||||||||
Cash, cash equivalents and short-term investments |
$1,966 |
$296 |
$ - |
$2,262 |
||||
Contracts receivable |
23 |
9 |
- |
32 |
||||
Other current assets |
106 |
23 |
(8) |
121 |
||||
Property, plant and equipment, net |
130 |
5 |
- |
135 |
||||
Other assets |
949 |
101 |
(722) |
328 |
||||
Total assets |
$3,174 |
$434 |
$(730) |
$2,878 |
||||
Liabilities and stockholders' equity: |
||||||||
Other current liabilities |
$78 |
$35 |
$ (9) |
$104 |
||||
Current portion of deferred contract revenue |
121 |
16 |
- |
137 |
||||
1% convertible senior notes |
587 |
- |
- |
587 |
||||
Long-term obligations, less current portion |
61 |
15 |
- |
76 |
||||
Long-term deferred contract revenue |
518 |
- |
(1) |
517 |
||||
Total stockholders' equity before noncontrolling interest |
1,809 |
368 |
(908) |
1,269 |
||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
188 |
188 |
||||
Total stockholders' equity |
1,809 |
368 |
(720) |
1,457 |
||||
Total liabilities and stockholders' equity |
$3,174 |
$434 |
$(730) |
$2,878 |
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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