Press Releases
Ionis Pharmaceuticals Reports Financial Results and Highlights for Third Quarter 2017
"With sales of over
"Inotersen is now under regulatory review in the U.S. and EU for the treatment of hereditary TTR amyloidosis (hATTR).
"Volanesorsen is now under review for marketing authorization in the U.S., EU, and
"We have also continued to advance our large, diverse pipeline of over 40 drugs. With continued growth in SPINRAZA sales, and inotersen and volanesorsen moving towards the market, we believe we are well on our way to becoming a multi-product, profitable, commercial company, delivering innovative medicines to patients in need," concluded Ms. Parshall.
Q1:17* |
Q2:17* |
Q3:17* |
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SPINRAZA Sales |
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Current Approvals |
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U.S. Administration Sites |
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U.S. Site Start Submission Forms |
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U.S. Insurance Coverage |
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Patients in EAP |
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Current Filings |
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*As announced by Biogen in their earnings call for the relevant quarter |
Financial Results
"We continued our strong financial performance in the third quarter of 2017. We reported pro forma operating income of
"As we prepare for the launch of inotersen and Akcea prepares for the launch of volanesorsen, we are projecting an increase in our operating expenses for the fourth quarter of 2017 compared to the third quarter of 2017. Even with this increase in operating expenses, we remain on track to meet our financial guidance for 2017 of pro forma operating income in the mid
All pro forma amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of pro forma and GAAP measures, which is provided later in this release.
Revenue
Ionis' revenue for the three and nine months ended
Commercial Revenue:
$60 million from SPINRAZA royalties; and$5 million from other licensing and royalty payments.
R&D Revenue:
$105 million from Biogen, including$50 million for the EU approval of SPINRAZA,$40 million for SPINRAZA pricing approval inJapan and$15 million for validating two undisclosed neurological disease targets;$67 million from Bayer primarily for the license of IONIS-FXI-LRx;$86 million from the amortization of upfront fees; and$12 million primarily from services Ionis performed for its partners.
Operating Expenses
Ionis' operating expenses for the three and nine months ended
Net Income (Loss)
Ionis reported a net loss of
Net Loss Attributable to Noncontrolling Interest in
Akcea sold shares of its common stock to third parties in its IPO. From the closing of the IPO through the end of the third quarter of 2017, Ionis owned 68 percent of Akcea. The shares held by third parties 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 holders 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 third quarter of 2017 was
Net Income (Loss) Attributable to
Ionis reported a net loss attributable to Ionis' common stockholders of
Balance Sheet
As of
Refer to the condensed consolidating statement of operations and balance sheet contained in the financial tables of this earnings release for further information on Ionis' noncontrolling interest in Akcea.
Conference Call
At
ABOUT
Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases. Using its proprietary antisense technology, Ionis has created a large pipeline of first-in-class or best-in-class drugs, with over three dozen drugs in development. SPINRAZA® (nusinersen) has been approved in global markets for the treatment of spinal muscular atrophy (SMA). Biogen is responsible for commercializing SPINRAZA. Drugs that have successfully completed Phase 3 studies include inotersen, an antisense drug Ionis is developing to treat patients with hereditary TTR amyloidosis (hATTR), and volanesorsen, an antisense drug discovered by Ionis and co-developed by Ionis and Akcea Therapeutics to treat patients with either familial chylomicronemia syndrome or familial partial lipodystrophy. Akcea, an affiliate of Ionis, is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders. If approved, volanesorsen will be commercialized through Ionis' affiliate, Akcea. Inotersen filings for marketing approval have been submitted in the U.S. and EU. Volanesorsen filings for marketing approval have been submitted in the U.S., EU, and
IONIS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding
In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to
Ionis Pharmaceuticals™ is a trademark of
(Q3 2017 and subsequent activities)
Recent SPINRAZA Accomplishments:
- Biogen reported more than
$270 million from sales of SPINRAZA in the third quarter, bringing 2017 year-to-date sales to more than$520 million . - Ionis earned a
$40 million milestone payment from Biogen for SPINRAZA pricing approval inJapan . - SPINRAZA was approved in
Brazil andSwitzerland , with additional approvals anticipated. - Ionis and Biogen received the prestigious
Prix Galien USA Award for the Best Biotechnology Product in 2017 for SPINRAZA. - Results from the ENDEAR study of SPINRAZA in patients with infantile-onset SMA were published in
The New England Journal of Medicine . - Ionis and Biogen received the 2016-2017 Oligonucleotide Therapeutics Society Paper of the Year Award for the Phase 2 SPINRAZA publication in The Lancet.
Recent Corporate and Pipeline Accomplishments:
- Ionis filed for marketing authorization for inotersen in the U.S. and EU.
- Ionis presented data from the NEURO-TTR study of inotersen at the
American Neurology Academy congress and European ATTR meeting demonstrating benefit compared to placebo in multiple measures of quality of life and disease severity, including both co-primary endpoints: the Norfolk quality of life score and mNIS+7. - Ionis entered into a collaboration with Seventh Sense Biosystems to support the development of a novel push-button blood collection device to make blood testing more convenient and virtually painless, potentially enabling more convenient monitoring for patients being treated with inotersen and volanesorsen.
AstraZeneca presented data from the Phase 1b/2 study of IONIS-STAT3-2.5Rx in combination with its PD-L1 blocking antibody, Imfinzi (durvalumab) showing encouraging antitumor activity in patients with advanced solid tumors and recurrent metastatic head and neck cancer, with a safety and tolerability profile supporting continued development.- Ionis initiated a Phase 1 study of IONIS-MAPTRx in patients with Alzheimer's disease and earned a
$10 million milestone payment from Biogen.
Recent Akcea Accomplishments:
- Akcea and Ionis filed for marketing authorization in the U.S., EU, and
Canada for volanesorsen for the treatment of FCS. - Volanesorsen was granted Priority Review in
Canada . - Akcea received Promising Innovative Medicine (PIM) designation for volanesorsen in the
United Kingdom . - Akcea announced positive results from the Phase 1/2 study of AKCEA-APOCIII-LRx in healthy volunteers and patients with elevated triglycerides.
- Akcea presented final results from the IN-FOCUS study demonstrating the significant burden of illness for patients with FCS at the
National Organization for Rare Disorders (NORD) Summit . - Akcea completed its initial public offering, including the underwriters' full exercise of their overallotment option generating over
$180 million in net proceeds. - Akcea expanded the leadership team in the U.S. and established a global presence in
Canada ,United Kingdom ,Germany , andFrance .
IONIS PHARMACEUTICALS, INC. |
|||||||||
SELECTED FINANCIAL INFORMATION |
|||||||||
Condensed Consolidated Statements of Operations |
|||||||||
(In Thousands, Except Per Share Data) |
|||||||||
Three months ended, |
Nine months ended, |
||||||||
September 30, |
September 30, |
||||||||
2017 |
2016 |
2017 |
2016 |
||||||
Revenue: |
(unaudited) |
(unaudited) |
|||||||
Commercial revenue: |
|||||||||
SPINRAZA royalties |
$32,890 |
$ - |
$60,467 |
$ - |
|||||
Licensing and royalty revenue |
879 |
2,014 |
4,983 |
19,689 |
|||||
Total commercial revenue |
33,769 |
2,014 |
65,450 |
19,689 |
|||||
Research and development revenue under collaborative agreements |
87,142 |
108,913 |
269,917 |
166,583 |
|||||
Total revenue |
120,911 |
110,927 |
335,367 |
186,272 |
|||||
Expenses: |
|||||||||
Research, development and patent expenses |
80,214 |
84,631 |
246,358 |
243,169 |
|||||
Selling, general and administrative |
26,788 |
10,188 |
62,782 |
30,574 |
|||||
Total operating expenses |
107,002 |
94,819 |
309,140 |
273,743 |
|||||
Income (loss) from operations |
13,909 |
16,108 |
26,227 |
(87,471) |
|||||
Other income (expense): |
|||||||||
Investment income |
2,811 |
989 |
7,504 |
3,912 |
|||||
Interest expense |
(10,825) |
(9,746) |
(33,966) |
(28,861) |
|||||
Loss on extinguishment of financing liability for leased facility |
(7,689) |
- |
(7,689) |
- |
|||||
Other expenses |
(2,141) |
- |
(3,528) |
- |
|||||
Income (loss) before income tax expense |
(3,935) |
7,351 |
(11,452) |
(112,420) |
|||||
Income tax expense |
(961) |
- |
(1,184) |
(1) |
|||||
Net income (loss) |
(4,896) |
7,351 |
(12,636) |
(112,421) |
|||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
3,920 |
- |
3,920 |
- |
|||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$(976) |
$7,351 |
$(8,716) |
$(112,421) |
|||||
Basic net income (loss) per share |
$(0.00) |
$0.06 |
$0.02 |
$(0.93) |
|||||
Diluted net income (loss) per share |
$(0.00) |
$0.06 |
$0.02 |
$(0.93) |
|||||
Shares used in computing basic net income (loss) per share |
124,370 |
120,989 |
123,746 |
120,795 |
|||||
Shares used in computing diluted net income (loss) per share |
124,370 |
123,378 |
123,746 |
120,795 |
IONIS PHARMACEUTICALS, INC. |
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Reconciliation of GAAP to Pro Forma Basis: |
||||||||
Condensed Consolidated Operating Expenses, Income (Loss) From Operations, and Net Income (Loss) |
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(In Thousands) |
||||||||
Three months ended, September 30, |
Nine months ended, September 30, |
|||||||
2017 |
2016 |
2017 |
2016 |
|||||
(unaudited) |
(unaudited) |
|||||||
As reported operating expenses according to GAAP |
$107,002 |
$94,819 |
$309,140 |
$273,743 |
||||
Excluding compensation expense related to equity awards |
(21,472) |
(17,586) |
(63,642) |
(56,950) |
||||
Pro forma operating expenses |
$85,530 |
$77,233 |
$245,498 |
$216,793 |
||||
As reported income (loss) from operations according to GAAP |
$13,909 |
$16,108 |
$26,227 |
$(87,471) |
||||
Excluding compensation expense related to equity awards |
(21,472) |
(17,586) |
(63,642) |
(56,950) |
||||
Pro forma income (loss) from operations |
$35,381 |
$33,694 |
$89,869 |
$(30,521) |
||||
As reported net income (loss) according to GAAP |
$(4,896) |
$7,351 |
$(12,636) |
$(112,421) |
||||
Excluding compensation expense related to equity awards |
(21,472) |
(17,586) |
(63,642) |
(56,950) |
||||
Pro forma net income (loss) |
$16,576 |
$24,937 |
$51,006 |
$(55,471) |
Reconciliation of GAAP to Pro Forma Basis
As illustrated in the Selected Financial Information in this press release, pro forma operating expenses, pro forma income (loss) from operations, and pro forma 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 pro forma results. These measures are provided as supplementary information and are not a substitute for financial measures calculated in accordance with GAAP. Ionis reports these pro forma 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' pro forma results is consistent with how Ionis' management internally evaluates the performance of its operations.
IONIS PHARMACEUTICALS, INC. |
|||||
Condensed Consolidated Balance Sheets |
|||||
(In Thousands) |
|||||
September 30, |
December 31, |
||||
2017 |
2016 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$1,010,808 |
$665,223 |
|||
Contracts receivable |
42,924 |
108,043 |
|||
Other current assets |
57,381 |
22,252 |
|||
Property, plant and equipment, net |
116,624 |
92,845 |
|||
Other assets |
24,824 |
24,104 |
|||
Total assets |
$1,252,561 |
$912,467 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$72,734 |
$82,504 |
|||
Current portion of deferred contract revenue |
104,913 |
51,280 |
|||
1% convertible senior notes |
524,744 |
500,511 |
|||
Long-term obligations, less current portion |
72,846 |
87,409 |
|||
Long-term deferred contract revenue |
79,656 |
91,198 |
|||
Total Ionis stockholders' equity |
307,968 |
99,565 |
|||
Noncontrolling interest in Akcea Therapeutics, Inc. |
89,700 |
- |
|||
Total stockholders' equity |
397,668 |
99,565 |
|||
Total liabilities and stockholders' equity |
$1,252,561 |
$912,467 |
|||
IONIS PHARMACEUTICALS, INC. |
||||||||
SELECTED FINANCIAL INFORMATION |
||||||||
Condensed Consolidating Statement of Operations |
||||||||
(In Thousands) |
||||||||
Nine months ended, September 30, 2017 (unaudited) |
||||||||
Ionis |
Akcea |
Eliminations |
Ionis |
|||||
Revenue: |
||||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$60,467 |
$ - |
$ - |
$60,467 |
||||
Licensing and royalty revenue |
4,983 |
- |
- |
4,983 |
||||
Total commercial revenue |
65,450 |
- |
- |
65,450 |
||||
Research and development revenue under collaborative agreements |
232,744 |
$37,173 |
- |
269,917 |
||||
Intercompany revenue |
54,407 |
- |
(54,407) |
- |
||||
Total revenue |
352,601 |
37,173 |
(54,407) |
335,367 |
||||
Expenses: |
||||||||
Research, development and patent expenses |
199,934 |
100,921 |
(54,497) |
246,358 |
||||
Selling, general and administrative |
42,819 |
19,963 |
- |
62,782 |
||||
Total operating expenses |
242,753 |
120,884 |
(54,497) |
309,140 |
||||
Income (loss) from operations |
109,848 |
(83,711) |
90 |
26,227 |
||||
Other income (expense): |
||||||||
Investment income |
8,241 |
994 |
(1,731) |
7,504 |
||||
Interest expense |
(33,966) |
(1,731) |
1,731 |
(33,966) |
||||
Loss on extinguishment of financing liability for leased facility |
(7,689) |
- |
- |
(7,689) |
||||
Other expenses |
(3,652) |
124 |
- |
(3,528) |
||||
Income (loss) before income tax expense |
72,782 |
(84,324) |
90 |
(11,452) |
||||
Income tax benefit (expense) |
882 |
(2,066) |
- |
(1,184) |
||||
Net income (loss) |
73,664 |
(86,390) |
90 |
(12,636) |
||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
3,920 |
3,920 |
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$73,664 |
$(86,390) |
$4,010 |
$(8,716) |
||||
IONIS PHARMACEUTICALS, INC. |
||||||||||||||||
Condensed Consolidating Balance Sheet |
||||||||||||||||
(In Thousands) |
||||||||||||||||
September 30, 2017 |
||||||||||||||||
(unaudited) |
||||||||||||||||
Ionis |
Akcea |
Eliminations |
Ionis Consolidated |
|||||||||||||
Assets: |
||||||||||||||||
Cash, cash equivalents and short-term investments |
$724,677 |
$286,131 |
$ - |
$1,010,808 |
||||||||||||
Contracts receivable |
42,424 |
500 |
- |
42,924 |
||||||||||||
Receivable from Akcea Therapeutics, Inc. |
9,501 |
- |
(9,501) |
- |
||||||||||||
Other current assets |
56,132 |
1,249 |
- |
57,381 |
||||||||||||
Property, plant and equipment, net |
116,520 |
104 |
- |
116,624 |
||||||||||||
Other assets |
297,733 |
1,365 |
(274,274) |
24,824 |
||||||||||||
Total assets |
$1,246,987 |
$289,349 |
$(283,775) |
$1,252,561 |
||||||||||||
Liabilities and stockholders' equity: |
||||||||||||||||
Other current liabilities |
$62,822 |
$19,413 |
$(9,501) |
$72,734 |
||||||||||||
Current portion of deferred contract revenue |
50,870 |
54,043 |
- |
104,913 |
||||||||||||
1% convertible senior notes |
524,744 |
- |
- |
524,744 |
||||||||||||
Long-term obligations, less current portion |
72,832 |
14 |
- |
72,846 |
||||||||||||
Long-term deferred contract revenue |
63,319 |
18,035 |
(1,698) |
79,656 |
||||||||||||
Total stockholders' equity before noncontrolling interest |
472,400 |
197,844 |
(362,276) |
307,968 |
||||||||||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
89,700 |
89,700 |
||||||||||||
Total stockholders' equity |
472,400 |
197,844 |
(272,576) |
397,668 |
||||||||||||
Total liabilities and stockholders' equity |
$1,246,987 |
$289,349 |
$(283,775) |
$1,252,561 |
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SOURCE
Ionis Pharmaceuticals Investor and Media Contacts: D. Wade Walke, Ph.D.; Vice President, Corporate Communications and Investor Relations; 760-603-2741 OR Alissa Santa Maria; Assistant Director, Corporate Development; 760-603-2643 OR Jennifer Capuzelo; Assistant Director, Corporate Communications and Investor Relations; 760-603-2606