Press Releases
Ionis reports first quarter 2019 financial results
"Our strong first quarter results put us on track to achieve our 2019 goals. We added commercial revenue from the first full quarter of the TEGSEDI launch to our growing commercial revenue from SPINRAZA. WAYLIVRA is now our third antisense medicine approved in just over two years, and we look forward to launching in
First Quarter 2019 Financial Results and Highlights
- Revenues more than doubled compared to Q1 2018
- Total revenue was
$297 million compared to$144 million in Q1 2018. - Commercial revenue from SPINRAZA® (nusinersen) was
$60 million compared to$41 million in Q1 2018. - TEGSEDI™ (inotersen) product sales were
$7 million in its first full quarter on the market and$9 million since launching in Q4 2018. - R&D revenue included
$150 million fromNovartis for its license of AKCEA-APO(a)-LRx and$35 million fromRoche when it enrolled the first patient in the Phase 3 study of IONIS-HTTRx (RG6042) in patients with Huntington's disease. - Achieved substantial operating income and net income
- Operating income and net income were
$121 million and$84 million , respectively, compared to an operating loss and net loss of$3 million and$1 million , respectively, in Q1 2018, all on a GAAP basis. - Non-GAAP operating income and net income were
$167 million and$126 million , respectively, compared to$25 million for both non-GAAP operating income and net income in Q1 2018. - Operating expenses increased in the first quarter primarily due to Ionis' investment in commercializing TEGSEDI.
- Substantial cash position grew to
$2.3 billion enabling aggressive investment broadly across Ionis' business
"We achieved another quarter of strong financial performance with both operating income and net income in the first quarter of 2019, substantially outperforming the same quarter in 2018. Our revenues in the first quarter were composed of growing commercial revenues from SPINRAZA royalties and TEGSEDI product sales, on top of substantial R&D revenues, driven in large part by the one-time
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.
Recent Business Highlights
- SPINRAZA – the worldwide standard-of-care for the treatment of people with all forms of spinal muscular atrophy
- Biogen reported worldwide sales of SPINRAZA of
$518 million in the first quarter of 2019, a 42 percent increase compared to Q1 2018, driven primarily by increased penetration in existing markets, new country launches and continued uptake in the U.S. by children and adult patients. - There were more than 7,500 SMA patients from over 40 countries on SPINRAZA treatment at the end of the first quarter of 2019, including commercial patients and patients in the expanded access program and clinical trials.
- SPINRAZA data from the ongoing NURTURE and SHINE open-label extension studies demonstrated continued durable efficacy and reinforced the safety profile of SPINRAZA in patients treated for up to 6 years, as presented by Biogen at the 2019 AAN Annual Meeting.
- TEGSEDI – launch underway in multiple markets for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
- TEGSEDI product sales were
$7 million in its first full quarter on the market and$9 million since launching in Q4 2018. - TEGSEDI received a positive Final Evaluation Document (FED) from the
National Institute for Health and Care Excellence (NICE) authorizing reimbursement for the treatment of patients with polyneuropathy due to hATTR amyloidosis inEngland . - Data presented at AAN from the TEGSEDI NEURO-TTR open-label extension study demonstrated long-term efficacy and safety in patients with hATTR.
- WAYLIVRA® (volanesorsen) – approved in the EU for the treatment of adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis
- Akcea's preparations to launch in the EU are underway, beginning in
Germany in Q3 2019. - Launch in additional EU countries is planned in 2020.
- Earned a
$6 million milestone payment fromPTC Therapeutics for the EU approval of WAYLIVRA. Roche presented nine-month data from the ongoing Phase 1/2 open-label extension study of IONIS-HTTRx (RG6042) in patients with Huntington's disease at AAN, demonstrating continued and sustained reductions in mutant huntingtin protein with bi-monthly dosing.- Based on these data,
Roche amended the dosing regimen in the Phase 3 study of IONIS-HTTRx (RG6042) in patients with Huntington's disease to replace the monthly dosing regimen with a tri-annual (every four months) dosing regimen. - Biogen presented data from the Phase 1/2 study of tofersen (IONIS-SOD1Rx) in ALS patients with SOD-1 mutations (SOD1-ALS) at AAN, demonstrating benefit in clinical measures of ALS disease progression after three months of treatment.
- Tofersen is in a Phase 3 clinical study that could support a rapid path to patients.
- Biogen is collaborating with regulators to further define the scope of the clinical data package required to support registration.
- Ionis generated a
$7.5 million milestone payment for advancing a new target for an unidentified neurological disease under its 2018 strategic neurology collaboration with Biogen. Brett P. Monia , Ph.D., chief operating officer of Ionis was appointed to the Ionis board of directors.
Key Upcoming Data Events
- Open-label extension study of IONIS-HTTRx (RG6042) in patients with Huntington's disease
- Phase 1/2 study of AKCEA-TTR-LRx in healthy volunteers
- BROADEN study of WAYLIVRA in patients with familial partial lipodystrophy (FPL)
- Development program targeting FXI for the treatment of patients with clotting disorders
- Development program for the treatment of patients with HBV infection
- Phase 2 study of IONIS-GHR-LRx in patients with acromegaly
- Phase 1 study of IONIS-ENAC-2.5Rx in healthy volunteers
Revenue
Ionis' revenue for the first quarter of 2019 was
Three months ended, |
||||
March 31, |
||||
2019 |
2018 |
|||
Revenue: |
||||
Commercial revenue: |
||||
SPINRAZA royalties |
$60 |
$41 |
||
TEGSEDI product sales, net |
7 |
- |
||
Licensing and royalty revenue |
1 |
1 |
||
Total commercial revenue |
68 |
42 |
||
R&D Revenue: |
||||
Amortization from upfront payments |
36 |
27 |
||
Milestone payments |
40 |
7 |
||
License fees |
150 |
62 |
||
Other services |
3 |
6 |
||
Total R&D revenue |
229 |
102 |
||
Total revenue |
$297 |
$144 |
In the first quarter of 2019, Ionis significantly increased both commercial revenue and R&D revenue. Commercial revenue from SPINRAZA royalties increased more than 45 percent. The Company also added growing TEGSEDI product sales to its commercial revenue.
Ionis' R&D revenue substantially increased in the first quarter of 2019 due to the
In the second quarter of 2019, Alnylam announced it licensed Ionis' technology to Regeneron. Once the transaction closes, Ionis expects to earn
Operating Expenses
Operating expenses for the first quarter of 2019 on a GAAP basis were $176 million and on a non-GAAP basis were $130 million. These amounts compare to GAAP operating expenses for the first quarter of 2018 of $147 million and non-GAAP operating expenses of
Income Tax Expense
Ionis recorded income tax expense of
Net (Income) 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 $84 million for the first quarter of 2019 compared to a net loss of
For the first quarter of 2019, basic and diluted net income per share were
Balance Sheet
Ionis added to its strong balance sheet, ending the first quarter of 2019 with cash, cash equivalents and short-term investments of $2.3 billion, compared to
Webcast and Conference Call
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 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), 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, |
||||
March 31, |
||||
2019 |
2018 |
|||
(unaudited) |
||||
Revenue: |
||||
Commercial revenue: |
||||
SPINRAZA royalties |
$60 |
$41 |
||
TEGSEDI product sales, net |
7 |
- |
||
Licensing and royalty revenue |
1 |
1 |
||
Total commercial revenue |
68 |
42 |
||
Research and development revenue under collaborative agreements |
229 |
102 |
||
Total revenue |
297 |
144 |
||
Expenses: |
||||
Cost of products sold |
1 |
- |
||
Research, development and patent |
107 |
104 |
||
Selling, general and administrative |
68 |
43 |
||
Total operating expenses |
176 |
147 |
||
Income (loss) from operations |
121 |
(3)
|
||
Other income (expense): |
||||
Investment income |
12 |
3 |
||
Interest expense |
(12) |
(10) |
||
Income (loss) before income tax benefit |
121 |
(10) |
||
Income tax expense |
(31) |
- |
||
Net income (loss) |
$90 |
$(10) |
||
Net (income) loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
(6) |
9 |
||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$84 |
$(1) |
||
Basic net income (loss) per share |
$0.63 |
$(0.01) |
||
Diluted net income (loss) per share |
$0.62 |
$(0.01) |
||
Shares used in computing basic net income (loss) per share |
138,582 |
125,330 |
||
Shares used in computing diluted net income (loss) per share |
141,537 |
125,330 |
IONIS PHARMACEUTICALS, INC. SELECTED FINANCIAL INFORMATION Condensed Consolidating Statement of Operations (In Millions) |
||||||||
Three months ended, March 31, 2019 (unaudited) |
||||||||
Ionis |
Akcea |
Eliminations |
Ionis |
|||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$60 |
$- |
$- |
$60 |
||||
TEGSEDI product sales, net |
- |
7 |
- |
7 |
||||
Licensing and royalty revenue |
1 |
- |
- |
1 |
||||
Total commercial revenue |
61 |
7 |
- |
68 |
||||
Research and development revenue under collaborative agreements |
72 |
157 |
- |
229 |
||||
Intercompany revenue |
88 |
- |
(88) |
- |
||||
Total revenue |
221 |
164 |
(88) |
297 |
||||
Expenses: |
||||||||
Cost of products sold |
- |
2 |
(1) |
1 |
||||
Research, development and patent expenses |
82 |
100 |
(75) |
107 |
||||
Selling, general and administrative |
23 |
45 |
- |
68 |
||||
Profit/ loss share for TEGSEDI commercialization activities |
9 |
(9) |
- |
- |
||||
Total operating expenses |
114 |
138 |
(76) |
176 |
||||
Income from operations |
107 |
26 |
(12) |
121 |
||||
Other income (expense): |
||||||||
Investment income |
11 |
1 |
- |
12 |
||||
Interest expense |
(12) |
- |
- |
(12) |
||||
Income before income tax expense |
106 |
27 |
(12) |
121 |
||||
Income tax expense |
(31) |
- |
- |
(31) |
||||
Net income |
$75 |
$27 |
(12) |
$90 |
||||
Net (income) loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
$- |
$- |
$(6) |
$(6) |
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$75 |
$27 |
$(18) |
$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, March 31, |
|||||
2019 |
2018 |
||||
(unaudited) |
|||||
As reported research, development and patent expenses according to GAAP |
$107 |
$104 |
|||
Excluding compensation expense related to equity awards |
(25) |
(20) |
|||
Non-GAAP research, development and patent expenses |
$82 |
$84 |
|||
As reported selling, general and administrative expenses according to GAAP |
$68 |
$43 |
|||
Excluding compensation expense related to equity awards |
(21) |
(8) |
|||
Non-GAAP selling, general and administrative expenses |
$47 |
$35 |
|||
As reported operating expenses according to GAAP |
$176 |
$147 |
|||
Excluding compensation expense related to equity awards |
(46) |
(28) |
|||
Non-GAAP operating expenses |
$130 |
$119 |
|||
As reported income (loss) from operations according to GAAP |
$121 |
$(3) |
|||
Excluding compensation expense related to equity awards |
(46) |
(28) |
|||
Non-GAAP income from operations |
$167 |
$25 |
|||
As reported net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$84 |
$(1) |
|||
Excluding compensation expense related to equity awards attributable to Ionis Pharmaceuticals, Inc. common stockholders |
(42) |
(26) |
|||
Non-GAAP net income attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$126 |
$25 |
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) |
|||||
March 31, |
December 31, |
||||
2019 |
2018 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$2,254 |
$2,084 |
|||
Contracts receivable |
10 |
13 |
|||
Other current assets |
110 |
111 |
|||
Property, plant and equipment, net |
134 |
132 |
|||
Other assets |
328 |
328 |
|||
Total assets |
$2,836 |
$2,668 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$108 |
$ 120 |
|||
Current portion of deferred contract revenue |
145 |
160 |
|||
1% convertible senior notes |
577 |
568 |
|||
Long-term obligations, less current portion |
76 |
65 |
|||
Long-term deferred contract revenue |
542 |
567 |
|||
Total Ionis stockholders' equity |
1,208 |
1,049 |
|||
Noncontrolling interest in Akcea Therapeutics, Inc. |
180 |
139 |
|||
Total stockholders' equity |
1,388 |
1,188 |
|||
Total liabilities and stockholders' equity |
$2,836 |
$2,668 |
|||
IONIS PHARMACEUTICALS, INC. Condensed Consolidating Balance Sheet (In Millions) |
||||||||
March 31, 2019 |
||||||||
(unaudited) |
||||||||
Ionis |
||||||||
Ionis |
Akcea |
Eliminations |
Consolidated |
|||||
Assets: |
||||||||
Cash, cash equivalents and short-term investments |
$1,932 |
$322 |
$- |
$2,254 |
||||
Contracts receivable |
- |
10 |
- |
10 |
||||
Other current assets |
102 |
19 |
(11) |
110 |
||||
Property, plant and equipment, net |
128 |
6 |
- |
134 |
||||
Other assets |
950 |
102 |
(724) |
328 |
||||
Total assets |
$3,112 |
$459 |
$(735) |
$2,836 |
||||
Liabilities and stockholders' equity: |
||||||||
Other current liabilities |
$87 |
$32 |
$(11) |
$108 |
||||
Current portion of deferred contract revenue |
123 |
22 |
- |
145 |
||||
1% convertible senior notes |
577 |
- |
- |
577 |
||||
Long-term obligations, less current portion |
61 |
15 |
- |
76 |
||||
Long-term deferred contract revenue |
542 |
2 |
(2) |
542 |
||||
Total stockholders' equity before noncontrolling interest |
1,722 |
388 |
(902) |
1,208 |
||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
180 |
180 |
||||
Total stockholders' equity |
1,722 |
388 |
(722) |
1,388 |
||||
Total liabilities and stockholders' equity |
$3,112 |
$459 |
$(735) |
$2,836 |
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SOURCE
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