Press Releases
Ionis Reports Third Quarter 2018 Financial Results
"We enter the fourth quarter in a position of financial strength, driven by strong worldwide SPINRAZA sales. In addition, we achieved numerous successes during the quarter that advanced our pipeline, technology and business and contributed to our financial strength. In 2019 and beyond, we are positioned for continued growth bolstered by the addition of TEGSEDI commercial revenue," said
Third Quarter 2018 Financial Highlights
- Revenues increased year-to-date by more than 15 percent compared to 2017
- Total revenue was
$145 million and$408 million for the third quarter and year-to-date 2018, respectively, compared to$118 million and$346 million for the same periods in 2017 - Commercial revenue from SPINRAZA for year-to-date 2018 was
$168 million , a nearly three-fold increase over year-to-date 2017 - Commercial revenue was 45 percent of Ionis' total revenue in the first nine months of 2018 compared to less than 20 percent for the same period in 2017, reflecting Ionis' transition to a commercial-stage company
- On track for third consecutive year of pro forma operating profitability while investing in the launches of two drugs
- GAAP operating results were a loss of
$19 million and$72 million for the third quarter and year-to-date 2018, respectively, compared to operating income of$11 million and$37 million for the same periods in 2017 - Pro forma operating income was
$16 million and$25 million for the third quarter and year-to-date 2018, respectively, compared to$33 million and$101 million for the same periods in 2017 - Operating expenses increased primarily due to higher SG&A expenses related to preparing to launch TEGSEDI and WAYLIVRA
- Substantial cash position of
$2 billion enabling investment in commercial products and pipeline - The increase in Ionis' cash position was primarily due to the
$1 billion Ionis received from Biogen for the 2018 strategic neurology collaboration
"Our strong third quarter financial results put us on track for our third consecutive year of pro forma operating income. In the fourth quarter, we are excited to add TEGSEDI commercial sales to our growing SPINRAZA revenue and substantial base of R&D revenue, positioning us for significant revenue growth going forward," said
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. Additionally, Ionis has labeled its prior period financial statements "as revised" to reflect the new revenue recognition accounting standard the Company adopted on
Business Highlights
- SPINRAZA – the first and only approved treatment for people with spinal muscular atrophy
- SPINRAZA sales continued to grow in the third quarter, both in the U.S. and ex-U.S., with global sales of more than
$1 billion for year-to-date 2018, as reported by Biogen. - Nearly 6,000 SMA patients were on SPINRAZA as of the third quarter.
- In the U.S., the number of adult patients on therapy grew by over 20 percent compared to the second quarter. Adult SMA patients, which represent the largest and most undertreated patient segment, accounted for more than 50 percent of start forms in the third quarter.
- Access outside the U.S. expanded with formal reimbursement in 28 markets and continued revenue growth in the EU,
Asia Pacific andLatin America . - TEGSEDI™ (inotersen) – launched in multiple markets for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients
- TEGSEDI approved in the U.S., EU and
Canada - Commercial patients in
Germany on TEGSEDI - TEGSEDI prescriptions received in the U.S.
- WAYLIVRA™ (volanesorsen) – under regulatory review for the treatment of people living with FCS
- Preparing for launch in the EU following approval
- Planning to confirm a path forward in the U.S. and
Canada
Pipeline and Business Progress
- Ionis and Akcea reported positive top-line data from a Phase 2 study of AKCEA-APO(a)-LRx in people with high levels of Lp(a) and established cardiovascular disease demonstrating robust target reductions and a favorable safety and tolerability profile
- Ionis and
Roche entered a new collaboration to develop IONIS-FB-LRx for the treatment of people with complement-mediated diseases. Ionis received a$75 million upfront payment and will be eligible for development, regulatory and sales milestone payments and license fees of up to$684 million plus royalties of up to 20 percent on commercial sales - Positive Phase 1b/2 data for danvatirsen (IONIS-STAT3-2.5Rx) in combination with durvalumab were presented at the
European Society for Medical Oncology (ESMO ) 2018Congress , demonstrating a response rate approximately double that of durvalumab alone, based on previous studies in patients with refractory head and neck cancer. Ionis earned a$17.5 million milestone payment becauseAstraZeneca is advancing the program - Ionis completed enrollment in a Phase 2b study of IONIS-FXIRx in patients with end-stage renal disease on dialysis, with data planned for mid-2019
- Ionis or its partners initiated clinical studies with IONIS-GHR-LRx (Phase 2), IONIS-C9Rx (Phase 1/2), IONIS-FXI-LRx and IONIS-AZ4-2.5-LRx (Phase 1)
- Ionis earned a
$10 million milestone payment fromAstraZeneca for advancing an undisclosed oncology program into development - Ionis appointed Dr.
Michael Hayden and Mr.Peter N. Reikes to its Board of Directors
Key Upcoming Events
- Potential approval and launch of WAYLIVRA in the EU
- Pivotal program initiation for IONIS-HTTRx in patients with Huntington's disease
- Results from up to three Phase 2 studies and four Phase 1 studies
- Initiations of up to three Phase 2 studies and two Phase 1 studies
Revenue
Ionis' revenue in the three and nine months ended
Three months ended, |
Nine months ended |
|||||||
September 30, |
September 30, |
|||||||
2018 |
2017 |
2018 |
2017 |
|||||
Revenue: |
(as revised) |
(as revised) |
||||||
Commercial revenue: |
||||||||
SPINRAZA royalties |
$70 |
$33 |
$168 |
$60 |
||||
Licensing and royalty revenue |
13 |
2 |
14 |
6 |
||||
Total commercial revenue |
83 |
35 |
182 |
66 |
||||
R&D Revenue: |
||||||||
Amortization from upfront payments |
31 |
23 |
92 |
70 |
||||
Milestone payments |
26 |
56 |
45 |
135 |
||||
License fees |
1 |
- |
64 |
65 |
||||
Other services |
4 |
4 |
25 |
10 |
||||
Total R&D revenue |
62 |
83 |
226 |
280 |
||||
Total revenue |
$145 |
$118 |
$408 |
$346 |
The increase in revenue in the first nine months of 2018 compared to the same period in 2017 was primarily due to increasing commercial revenue from SPINRAZA royalties, which increased over 175 percent. Our R&D revenue for the first nine months of 2018 was significant and demonstrates our ability to generate sustainable revenue from our numerous partnerships.
R&D revenue from the amortization of upfront payments increased by
Ionis' 2018 R&D revenue from milestone payments was bolstered by two
Operating Expenses
Operating expenses for the three and nine months ended
Net Income (Loss) Attributable to Ionis Common Stockholders
Ionis reported a net loss attributable to Ionis' common stockholders of $5 million and
At
For the three months ended
Balance Sheet
As of September 30, 2018, Ionis had cash, cash equivalents and short-term investments of $2 billion compared to $1 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 drugs 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, TEGSEDI (inotersen), 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 Thousands, Except Per Share Data) |
|||||||
Three months ended, |
Nine months ended, |
||||||
September 30, |
September 30, |
||||||
2018 |
2017 |
2018 |
2017 |
||||
(as revised) |
(as revised) |
||||||
Revenue: |
(unaudited) |
||||||
Commercial revenue: |
|||||||
SPINRAZA royalties |
$70,010 |
$32,890 |
$167,743 |
$60,467 |
|||
Licensing and royalty revenue |
12,746 |
1,727 |
14,232 |
5,639 |
|||
Total commercial revenue |
82,756 |
34,617 |
181,975 |
66,106 |
|||
Research and development revenue under collaborative agreements |
62,639 |
83,697 |
225,584 |
280,281 |
|||
Total revenue |
145,395 |
118,314 |
407,559 |
346,387 |
|||
Expenses: |
|||||||
Research, development and patent |
95,255 |
80,214 |
301,153 |
246,358 |
|||
Selling, general and administrative |
68,712 |
26,788 |
178,563 |
62,782 |
|||
Total operating expenses |
163,967 |
107,002 |
479,716 |
309,140 |
|||
Income (loss) from operations |
(18,572) |
11,312 |
(72,157) |
37,247 |
|||
Other income (expense): |
|||||||
Investment income |
9,963 |
2,811 |
18,711 |
7,504 |
|||
Interest expense |
(11,282) |
(10,825) |
(33,332) |
(33,966) |
|||
Loss on debt extinguishment |
- |
(7,689) |
- |
(7,689) |
|||
Other expenses |
(22) |
(2,141) |
(145) |
(3,528) |
|||
Income (loss) before income tax expense |
(19,913) |
(6,532) |
(86,923) |
(432) |
|||
Income tax expense |
(452) |
(961) |
(824) |
(1,184) |
|||
Net income (loss) |
$(20,365) |
$(7,493) |
$(87,747) |
$(1,616) |
|||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
15,806 |
4,882 |
41,412 |
4,882 |
|||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$(4,559) |
$(2,611) |
$(46,335) |
$3,266 |
|||
Basic net income (loss) per share |
$(0.03) |
$(0.02) |
$(0.33) |
$0.13 |
|||
Diluted net income (loss) per share |
$(0.03) |
$(0.02) |
$(0.33) |
$0.13 |
|||
Shares used in computing basic net income (loss) per share |
143,314 |
124,370 |
132,518 |
123,746 |
|||
Shares used in computing diluted net income (loss) per share |
143,314 |
124,370 |
132,518 |
125,858 |
IONIS PHARMACEUTICALS, INC. |
|||||||
SELECTED FINANCIAL INFORMATION |
|||||||
Condensed Consolidating Statement of Operations |
|||||||
(In Thousands) |
|||||||
Nine months ended, |
|||||||
September 30, 2018 |
|||||||
(unaudited) |
|||||||
Ionis |
Akcea |
Eliminations |
Ionis |
||||
Revenue: |
|||||||
Commercial revenue: |
|||||||
SPINRAZA royalties |
$167,743 |
$- |
$- |
$167,743 |
|||
Licensing and royalty revenue |
9,432 |
12,000 |
(7,200) |
14,232 |
|||
Total commercial revenue |
177,175 |
12,000 |
(7,200) |
181,975 |
|||
Research and development revenue under collaborative agreements |
182,914 |
42,670 |
- |
225,584 |
|||
Intercompany revenue |
49,937 |
- |
(49,937) |
- |
|||
Total revenue |
410,026 |
54,670 |
(57,137) |
407,559 |
|||
Expenses: |
|||||||
Research, development and patent expenses |
209,690 |
96,808 |
(5,345) |
301,153 |
|||
Selling, general and administrative |
69,394 |
116,620 |
(7,451) |
178,563 |
|||
Total operating expenses |
279,084 |
213,428 |
(12,796) |
479,716 |
|||
Income (loss) from operations |
130,942 |
(158,758) |
(44,341) |
(72,157) |
|||
Other income (expense): |
|||||||
Investment income |
14,625 |
4,086 |
- |
18,711 |
|||
Interest expense |
(33,332) |
- |
- |
(33,332) |
|||
Other expenses |
- |
(145) |
- |
(145) |
|||
Income (loss) before income tax expense |
112,235 |
(154,817) |
(44,341) |
(86,923) |
|||
Income tax expense |
(377) |
(447) |
- |
(824) |
|||
Net income (loss) |
$111,858 |
$(155,264) |
$(44,341) |
$(87,747) |
|||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
41,412 |
41,412 |
|||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders |
$111,858 |
$(155,264) |
$(2,929) |
$(46,335) |
IONIS PHARMACEUTICALS, INC. |
|||||||
Reconciliation of GAAP to Pro Forma Basis: |
|||||||
Condensed Consolidated Operating Expenses, Income (Loss) From Operations, and Net Income (Loss) |
|||||||
(In Thousands) |
|||||||
Three months ended, September 30, |
Nine months ended, September 30, |
||||||
2018 |
2017 |
2018 |
2017 |
||||
(as revised) |
(as revised) |
||||||
(unaudited) |
|||||||
As reported operating expenses according to GAAP |
$163,967 |
$107,002 |
$479,716 |
$309,140 |
|||
Excluding compensation expense related to equity awards |
(34,883) |
(21,472) |
(97,210) |
(63,642) |
|||
Pro forma operating expenses |
$129,084 |
$85,530 |
$382,506 |
$245,498 |
|||
As reported income (loss) from operations according to GAAP |
$(18,572) |
$11,312 |
$(72,157) |
$37,247 |
|||
Excluding compensation expense related to equity awards |
(34,883) |
(21,472) |
(97,210) |
(63,642) |
|||
Pro forma income from operations |
$16,311 |
$32,784 |
$25,053 |
$100,889 |
|||
As reported net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$(4,559) |
$(2,611) |
$(46,335) |
$3,266 |
|||
Excluding compensation expense related to equity awards |
(34,883) |
(21,472) |
(97,210) |
(63,642) |
|||
Pro forma net income attributable to Ionis Pharmaceuticals, Inc. common stockholders according to GAAP |
$30,324 |
$18,861 |
$50,875 |
$66,908 |
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) (unaudited) |
|||||
September 30, |
December 31, |
||||
2018 |
2017 |
||||
(as revised) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$1,958,989 |
$1,022,715 |
|||
Contracts receivable |
14,732 |
62,955 |
|||
Other current assets |
105,503 |
83,064 |
|||
Property, plant and equipment, net |
132,003 |
121,907 |
|||
Other assets |
36,686 |
32,133 |
|||
Total assets |
$2,247,913 |
$1,322,774 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$103,093 |
$118,276 |
|||
Current portion of deferred contract revenue |
157,145 |
125,336 |
|||
1% convertible senior notes |
559,184 |
533,111 |
|||
Long-term obligations, less current portion |
64,963 |
72,745 |
|||
Long-term deferred contract revenue |
523,384 |
108,026 |
|||
Total Ionis stockholders' equity |
710,550 |
281,013 |
|||
Noncontrolling interest in Akcea Therapeutics, Inc. |
129,594 |
84,267 |
|||
Total stockholders' equity |
840,144 |
365,280 |
|||
Total liabilities and stockholders' equity |
$2,247,913 |
$1,322,774 |
IONIS PHARMACEUTICALS, INC. |
||||||||||||||||
Condensed Consolidating Balance Sheet |
||||||||||||||||
(In Thousands) |
||||||||||||||||
September 30, 2018 |
||||||||||||||||
(unaudited) |
||||||||||||||||
Ionis |
||||||||||||||||
Ionis |
Akcea |
Eliminations |
Consolidated |
|||||||||||||
Assets: |
||||||||||||||||
Cash, cash equivalents and short-term investments |
$1,638,674 |
$320,315 |
$- |
$1,958,989 |
||||||||||||
Contracts receivable |
14,096 |
636 |
- |
14,732 |
||||||||||||
Receivable from Akcea Therapeutics, Inc. |
23,888 |
- |
(23,888) |
- |
||||||||||||
Other current assets |
99,952 |
8,397 |
(2,846) |
105,503 |
||||||||||||
Property, plant and equipment, net |
126,246 |
5,757 |
- |
132,003 |
||||||||||||
Other assets |
543,569 |
44,023 |
(550,906) |
36,686 |
||||||||||||
Total assets |
$2,446,425 |
$379,128 |
$(577,640) |
$2,247,913 |
||||||||||||
Liabilities and stockholders' equity: |
||||||||||||||||
Other current liabilities |
$71,574 |
$58,252 |
$(26,733) |
$103,093 |
||||||||||||
Current portion of deferred contract revenue |
124,798 |
32,347 |
- |
157,145 |
||||||||||||
1% convertible senior notes |
559,184 |
- |
- |
559,184 |
||||||||||||
Long-term obligations, less current portion |
60,310 |
4,653 |
- |
64,963 |
||||||||||||
Long-term deferred contract revenue |
522,619 |
2,464 |
(1,699) |
523,384 |
||||||||||||
Total stockholders' equity before noncontrolling interest |
1,107,940 |
281,412 |
(678,802) |
710,550 |
||||||||||||
Noncontrolling interest in Akcea Therapeutics, Inc. |
- |
- |
129,594 |
129,594 |
||||||||||||
Total stockholders' equity |
1,107,940 |
281,412 |
(549,208) |
840,144 |
||||||||||||
Total liabilities and stockholders' equity |
$2,446,425 |
$379,128 |
$(577,640) |
$2,247,913 |
SPINRAZA Q3 2017 – Q3 2018 Patient Dynamics |
|||||
U.S. Patient Dynamics* |
Q3:17 |
Q4:17 |
Q1:18 |
Q2:18 |
Q3:18 |
Total patients |
1,230 |
1,640 |
1,910 |
2,160 |
2,410 |
New patient starts |
520 |
420 |
290 |
270 |
260 |
Average doses per patient |
1.8 |
1.5 |
1.2 |
1.1 |
1.1 |
% Loading doses |
90% |
75% |
60% |
45% |
40% |
% Maintenance doses |
10% |
25% |
40% |
55% |
60% |
% Free doses |
20% |
20% |
20% |
15% |
15% |
*As reported by Biogen |
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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