Press Releases
Ionis provides third quarter financial results and improved 2019 guidance
"Our commitment to innovation and to advancing our antisense technology has enabled us to produce a broad pipeline of potentially transformational medicines for patients with rare and common diseases. Our commercial medicines, SPINRAZA, TEGSEDI and WAYLIVRA, are important examples of the life-changing potential of our pipeline. In early October, we licensed AKCEA-ANGPTL3-LRx to Pfizer, which plans to develop it for the millions of people with certain cardiovascular and metabolic diseases. The favorable up-front and back-end economics we achieved with this transaction, coupled with the recent commitments by
Revised 2019 Financial Guidance
The Company's revised full year 2019 financial guidance consists of the following components (on a non-GAAP basis):
Improved Guidance |
Previous Guidance |
|
Total Revenue |
~$1 billion |
>$725 million |
R&D Expenses |
unchanged |
~$360 million to $390 million |
SG&A Expenses |
unchanged |
~$260 million to $290 million |
Operating Income |
>$375 million |
>$100 million |
Net Income |
>$300 million |
achieve net income |
Cash and Short-Term Investments |
~$2.2 billion |
~$2 billion |
"Our strong financial results put us on track to achieve
Year-to-Date 2019 Financial Results and Highlights
- Revenues for the first nine months ended
September 30, 2019 increased by more than 50 percent, driven by SPINRAZA's continued blockbuster performance and increasing R&D revenue- Commercial revenue from SPINRAZA® (nusinersen) royalties increased by more than 25 percent to
$212 million compared to 2018. - Product sales from TEGSEDI® (inotersen) and WAYLIVRA® (volanesorsen) were
$29 million . - R&D revenue increased by more than 65 percent to
$377 million compared to 2018.
- Commercial revenue from SPINRAZA® (nusinersen) royalties increased by more than 25 percent to
- On track to achieve the fourth consecutive year of operating income and third consecutive year of net income, both on a non-GAAP basis
- Operating income and net income significantly improved to
$105 million and$110 million , respectively, compared to 2018, on a GAAP basis. - Non-GAAP operating income increased by more than 8-fold compared to 2018.
- Non-GAAP net income increased by more than 4-fold compared to 2018.
- Operating income and net income significantly improved to
- Maintained substantial cash position of
$2.2 billion for the third quarter - Ionis' board of directors approved an initial share repurchase program of up to
$125 million . The company may consider additional share repurchases in the future as part of the company's overall capital allocation strategy.
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.
"With Phase 3 programs for AKCEA-APO(a)-LRx and AKCEA-TTR-LRx expected to begin soon, we are on track to achieve our goal of advancing four late-stage medicines into Phase 3 development this year. These programs, together with our medicines for Huntington's disease and SOD1-ALS, represent significant commercial opportunities. We had multiple new medicines enter development, including our medicine targeting LRRK2 for the treatment of people with Parkinson's disease. We also added multiple wholly owned programs to our already broad pipeline," said
Recent Business Highlights
- SPINRAZA – global foundation-of-care for the treatment of patients of all ages with spinal muscular atrophy (SMA)
- Worldwide sales of SPINRAZA in the first nine months of 2019 increased by nearly 25 percent to over
$1.5 billion compared to last year. - Patients on SPINRAZA treatment increased by approximately 11 percent compared to last quarter to approximately 9,300 patients across global commercial, clinical and expanded access settings.
- Biogen plans to initiate the Phase 2/3 DEVOTE study evaluating the safety and potential to achieve increased efficacy with a higher dose of SPINRAZA in SMA patients of all ages, including adults.
- Biogen presented new long-term follow up data from NURTURE and SHINE, adding to the body of evidence underscoring SPINRAZA's durable efficacy and established safety profile across a broad range of SMA patients.
- NURTURE: Data from pre-symptomatic infants treated for up to nearly four years demonstrating consistent safety and unprecedented motor milestone achievement compared to natural history were published online in Neuromuscular Disorders.
- SHINE: Data demonstrating continuing improvement or stabilization in one or more measures of motor function in patients with later-onset SMA treated with SPINRAZA for up to nearly six years were presented at the annual
Congress of theEuropean Pediatric Neurology Society .
- Worldwide sales of SPINRAZA in the first nine months of 2019 increased by nearly 25 percent to over
- TEGSEDI – launched in multiple markets for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
- Approved in
Brazil and preparing to launch throughPTC Therapeutics - First commercial patients treated in the
United Kingdom following acceptance by theNational Institute for Health and Care Excellence (NICE) and theScottish Medicines Consortium (SMC) - Successfully completed pricing negotiations in Germany
- Launched in
Sweden andAustria following successful completion of reimbursement negotiations - Preparing to launch in additional EU countries
- Approved in
- WAYLIVRA – launched in the EU for the treatment of adults with genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for pancreatitis
- First commercial patients treated in
Germany , and a reimbursed early access program (ATU) launched inFrance - Preparing to launch in additional EU countries
- Published results from Phase 3 APPROACH study in patients with FCS in
The New England Journal of Medicine (NEJM) - Reported top-line results from the BROADEN study of WAYLIVRA in patients with familial partial lipodystrophy (FPL), which met the primary endpoint and a key secondary endpoint
- First commercial patients treated in
- Biogen Collaboration – Developing robust pipeline of medicines for the treatment of neurological diseases
- Dosed the first patient in a Phase 1/2 study targeting LRRK2 for the treatment of people with Parkinson's disease
- Advanced multiple programs, with eight programs now in development
- Ionis and Akcea generated
$250 million when Pfizer licensed AKCEA-ANGPTL3-LRx to treat patients with certain cardiovascular and metabolic diseases.- The companies are eligible to receive up to
$1.3 billion in milestone payments plus tiered double-digit royalties on worldwide net sales. - Ionis' 50 percent portion of the
$250 million license fee is expected to be settled in Akcea common stock, demonstrating Ionis' confidence in the future of Akcea.
- The companies are eligible to receive up to
- Ionis earned a
$25 million license fee from GSK to develop and commercialize Ionis' program for the treatment of people with chronic hepatitis B virus infection. - Ionis generated
$10 million from Bayer to advance IONIS-FXI-LRx for the treatment of people with clotting disorders. - Akcea and Ionis presented data from the Phase 1/2 study of AKCEA-TTR-LRx in healthy volunteers demonstrating >90 percent target reduction and a positive safety profile at the European ATTR Amyloidosis meeting and at the
Heart Failure Society of America . Roche expanded enrollment in the GENERATION HD1 Phase 3 study of IONIS-HTTRx (RG6042) in patients with Huntington's disease (HD).- Ionis initiated a Phase 2 study of IONIS-FB-LRx in patients with IgA nephropathy, the second disease indication under its collaboration with
Roche to develop the medicine for complement-mediated diseases.
Key Upcoming Events
- Ionis and GSK plan to report data from the HBV clinical program at the AASLD Liver Meeting in
November 2019 . - Ionis and Akcea plan to initiate the Phase 3 program for AKCEA-TTR-LRx in the fourth quarter of 2019.
Novartis plans to begin enrolling patients in the Phase 3 HORIZON cardiovascular outcomes study of AKCEA-APO(a)-LRx.- Akcea and Ionis plan to report top line results from Phase 2 studies of AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx in early 2020.
- Ionis plans to report data from healthy volunteers evaluated in a Phase 1 study of IONIS-ENaC-2.5Rx, an aerosol-delivered medicine in development for the treatment of people with cystic fibrosis.
Roche plans to present data from the open-label extension portion of the Phase 1/2 study of IONIS-HTTRx (RG6042) and natural history study in patients with Huntington's disease.
Revenue
Ionis' revenue increased by more than 50 percent for the first nine months of 2019 compared to the same period in 2018 and was comprised of the following (amounts in millions):
Three months ended, |
Nine months ended |
|||||||
September 30, |
September 30, |
|||||||
2019 |
2018 |
2019 |
2018 |
|||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$82 |
$70 |
$212 |
$168 |
||||
Product sales, net |
12 |
- |
29 |
- |
||||
Licensing and royalty revenue |
2 |
13 |
11 |
14 |
||||
Total commercial revenue |
96 |
83 |
252 |
182 |
||||
R&D Revenue: |
||||||||
Amortization from upfront payments |
23 |
31 |
100 |
92 |
||||
Milestone payments |
12 |
26 |
64 |
45 |
||||
License fees |
26 |
1 |
198 |
64 |
||||
Other services |
11 |
4 |
15 |
25 |
||||
Total R&D revenue |
72 |
62 |
377 |
226 |
||||
Total revenue |
$168 |
$145 |
$629 |
$408 |
In the fourth quarter of 2019, Ionis expects to recognize substantially all of the
Operating Expenses
Operating expenses increased for the nine months ended
Income Tax Expense
Ionis' income tax expense in the nine months of this year was primarily due to Ionis' expectation that it will generate U.S. federal and state taxable income in 2019.
Net Loss Attributable to Noncontrolling Interest in Akcea
At
Net Income (Loss) Attributable to Ionis Common Stockholders
The increase in Ionis' net income attributable to Ionis' common stockholders for the three and nine months ended
Ionis' basic and diluted earnings per share also improved during the three months and nine months ended
Balance Sheet
Ionis maintained its strong balance sheet, ending the third quarter of 2019 with cash, cash equivalents and short-term investments of $2.2 billion, compared to
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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, |
Nine months ended, |
|||||||
September 30, |
September 30, |
|||||||
2019 |
2018 |
2019 |
2018 |
|||||
(unaudited) |
||||||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$82 |
$70 |
$212 |
$168 |
||||
Product sales, net |
12 |
- |
29 |
- |
||||
Licensing and royalty revenue |
2 |
13 |
11 |
14 |
||||
Total commercial revenue |
96 |
83 |
252 |
182 |
||||
Research and development revenue under collaborative agreements |
72 |
62 |
377 |
226 |
||||
Total revenue |
168 |
145 |
629 |
408 |
||||
Expenses: |
||||||||
Cost of products sold |
1 |
- |
3 |
- |
||||
Research, development and patent |
104 |
95 |
317 |
301 |
||||
Selling, general and administrative |
60 |
69 |
204 |
179 |
||||
Total operating expenses |
165 |
164 |
524 |
480 |
||||
Income (loss) from operations |
3 |
(19) |
105 |
(72) |
||||
Other income (expense): |
||||||||
Investment income |
13 |
10 |
39 |
19 |
||||
Interest expense |
(12) |
(11) |
(35) |
(34) |
||||
Income (loss) before income tax benefit (expense) |
4 |
(20) |
109 |
(87) |
||||
Income tax benefit (expense) |
14 |
- - |
(10) |
(1) |
||||
Net income (loss) |
$18 |
$(20) |
$99 |
$(88) |
||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
8 |
15 |
11 |
42 |
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$26 |
$(5) |
$110 |
$(46) |
||||
Basic net income (loss) per share |
$0.19 |
$(0.03) |
$0.81 |
$(0.33) |
||||
Diluted net income (loss) per share |
$0.18 |
$(0.03) |
$0.79 |
$(0.33) |
||||
Shares used in computing basic net income (loss) per share |
141 |
137 |
140 |
131 |
||||
Shares used in computing diluted net income (loss) per share |
143 |
137 |
143 |
131 |
IONIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION Condensed Consolidating Statement of Operations
(In Millions)
|
||||||||
Nine months ended, |
||||||||
(unaudited) |
||||||||
Ionis |
Akcea |
Eliminations |
Ionis Consolidated |
|||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$ |
$212 |
$ - |
$ - |
$212 |
|||
Product sales, net |
- |
29 |
- |
29 |
||||
Licensing and royalty revenue |
5 |
6 |
- |
11 |
||||
Total commercial revenue |
217 |
35 |
- |
252 |
||||
Research and development revenue under collaborative agreements |
201 |
176 |
- |
377 |
||||
Intercompany revenue |
97 |
- |
(97) |
- |
||||
Total revenue |
515 |
211 |
(97) |
629 |
||||
Expenses: |
||||||||
Cost of products sold |
- |
10 |
(7) |
3 |
||||
Research, development and patent expenses |
253 |
145 |
(81) |
317 |
||||
Selling, general and administrative |
102 |
102 |
- |
204 |
||||
Profit/ loss share for TEGSEDI commercialization activities |
29 |
(29) |
- |
- |
||||
Total operating expenses |
384 |
228 |
(88) |
524 |
||||
Income (loss) from operations |
131 |
(17) |
(9) |
105 |
||||
Other income (expense): |
||||||||
Investment income |
35 |
4 |
- |
39 |
||||
Interest expense |
(35) |
- |
- |
(35) |
||||
Income (loss) before income tax expense |
131 |
(13) |
(9) |
109 |
||||
Income tax expense |
(9) |
(1) |
- |
(10) |
||||
Net income (loss) |
$122 |
$(14) |
$(9) |
$99 |
||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
11 |
11 |
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$122 |
$(14) |
$2 |
$110 |
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, September 30, |
Nine months ended, September 30, |
||||||||
2019 |
2018 |
2019 |
2018 |
||||||
(unaudited) |
|||||||||
As reported research, development and patent expenses according to GAAP |
$104 |
$95 |
$317 |
$301 |
|||||
Excluding compensation expense related to equity awards |
(24) |
(19) |
(72) |
(57) |
|||||
Non-GAAP research, development and patent expenses |
$80 |
$76 |
$245 |
$244 |
|||||
As reported selling, general and administrative expenses according to GAAP |
$60 |
$69 |
$204 |
$179 |
|||||
Excluding compensation expense related to equity awards |
- |
(16) |
(39) |
(40) |
|||||
Non-GAAP selling, general and administrative expenses |
$60 |
$53 |
$165 |
$139 |
|||||
As reported operating expenses according to GAAP |
$165 |
$164 |
$524 |
$480 |
|||||
Excluding compensation expense related to equity awards |
(24) |
(35) |
(112) |
(97) |
|||||
Non-GAAP operating expenses |
$141 |
$129 |
$412 |
$383 |
|||||
As reported income (loss) from operations according to GAAP |
$3 |
$(19) |
$105 |
$(72) |
|||||
Excluding compensation expense related to equity awards |
(24) |
(35) |
(112) |
(97) |
|||||
Non-GAAP income from operations |
$27 |
$16 |
$217 |
$25 |
|||||
As reported net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$26 |
$(5) |
$110 |
$(46) |
|||||
Excluding compensation expense related to equity awards attributable to Ionis Pharmaceuticals, Inc. common stockholders |
(25) |
(32) |
(104) |
(89) |
|||||
Income tax effect related to compensation expense related to equity awards attributable to Ionis Pharmaceuticals, Inc. common stockholders |
12 |
- |
25 |
- |
|||||
Non-GAAP net income attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$39 |
$27 |
$189 |
$43 |
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) attributable to
IONIS PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets |
||||||
September 30, |
December 31, |
|||||
2019 |
2018 |
|||||
(unaudited) |
||||||
Assets: |
||||||
Cash, cash equivalents and short-term investments |
$2,221 |
$2,084 |
||||
Contracts receivable |
49 |
13 |
||||
Other current assets |
138 |
111 |
||||
Property, plant and equipment, net |
149 |
132 |
||||
Other assets |
338 |
328 |
||||
Total assets |
$2,895 |
$2,668 |
||||
Liabilities and stockholders' equity: |
||||||
Other current liabilities |
$94 |
$ 120 |
||||
Current portion of deferred contract revenue |
138 |
160 |
||||
1% convertible senior notes |
596 |
568 |
||||
Long-term obligations, less current portion |
76 |
65 |
||||
Long-term deferred contract revenue |
493 |
567 |
||||
Total Ionis stockholders' equity |
1,336 |
1,049 |
||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
162 |
139 |
||||
Total stockholders' equity |
1,498 |
1,188 |
||||
Total liabilities and stockholders' equity |
$2,895 |
$2,668 |
||||
IONIS PHARMACEUTICALS, INC. Condensed Consolidating Balance Sheet (In Millions) |
||||||||
September 30, 2019 |
||||||||
(unaudited) |
||||||||
Ionis |
||||||||
Ionis |
Akcea |
Eliminations |
Consolidated |
|||||
Assets: |
||||||||
Cash, cash equivalents and short-term investments |
$1,968 |
$253 |
$- |
$2,221 |
||||
Contracts receivable |
38 |
11 |
- |
49 |
||||
Other current assets |
124 |
14 |
- |
138 |
||||
Property, plant and equipment, net |
144 |
5 |
- |
149 |
||||
Other assets |
959 |
100 |
(721) |
338 |
||||
Total assets |
$3,233 |
$383 |
$(721) |
$2,895 |
||||
Liabilities and stockholders' equity: |
||||||||
Other current liabilities |
$62 |
$32 |
$- |
$94 |
||||
Current portion of deferred contract revenue |
127 |
11 |
- |
138 |
||||
1% convertible senior notes |
596 |
- |
- |
596 |
||||
Long-term obligations, less current portion |
61 |
15 |
- |
76 |
||||
Long-term deferred contract revenue |
495 |
- |
(2) |
493 |
||||
Total stockholders' equity before noncontrolling interest |
1,892 |
325 |
(881) |
1,336 |
||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
162 |
162 |
||||
Total stockholders' equity |
1,892 |
325 |
(719) |
1,498 |
||||
Total liabilities and stockholders' equity |
$3,233 |
$383 |
$(721) |
$2,895 |
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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