Ionis reports second quarter 2020 financial results and recent business achievements
CARLSBAD, Calif., Aug. 5, 2020 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today reported its financial results for the second quarter of 2020 and recent business highlights.
"The first half of this year was marked by numerous important achievements. Our Phase 3 programs progressed, we advanced our cardio-renal, metabolic and neurological disease franchises and added new medicines to our Ionis-owned pipeline. Together, these catalysts moved us closer to delivering 10 or more marketing applications through 2025, which we expect to result in a number of new commercial medicines. In the second half of this year, we are expanding the reach of our technology in neurological and pulmonary diseases, as studies in sporadic ALS and COPD get underway. We also look forward to proof-of-concept data from additional mid-stage programs," said Brett P. Monia, Ph.D., chief executive officer at Ionis. "Our achievements, together with our significant financial resources, position us to realize my vision for Ionis - to lead in the delivery of transformational medicines for patients around the world."
Second Quarter 2020 Financial Results and Highlights
-- On track to achieve financial guidance of being meaningfully profitable
this year
-- Net income of $8 million on a non-GAAP basis and a net loss of $32
million on a GAAP basis
-- Achieved quarter over quarter growth in commercial and R&D revenues
-- Commercial revenue from SPINRAZA(®) (nusinersen) royalties
increased to $72 million
-- Product sales from TEGSEDI(®) (inotersen) and WAYLIVRA(®)
(volanesorsen) increased to $16 million
-- R&D revenue increased to more than $55 million, including $26
million from Ionis' neurological disease franchise, $13 million from
the oncology franchise and more than $10 million from the
cardio-renal franchise
-- Cash position of more than $2.3 billion provides substantial financial
resources to continue executing on strategic goals
"We ended the second quarter with net income on a non-GAAP basis, an increase compared to our first quarter results. Looking ahead, we are maintaining our 2020 financial guidance and expect revenue and earnings growth in the second half of this year. With our substantial resources, we are well positioned to continue executing on our ambitious agenda and to deliver increasing value near-term and into the future," said Elizabeth L. Hougen, chief financial officer of Ionis.
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.
Commercial Medicine Highlights
-- SPINRAZA: a global foundation-of-care for the treatment of spinal
muscular atrophy (SMA) patients of all ages
-- $495 million in worldwide sales in the second quarter of this year
-- More than 11,000 patients were on SPINRAZA treatment worldwide at
the end of the second quarter, including patients across commercial,
expanded access and clinical trial settings
-- The Phase 4 RESPOND study to evaluate SPINRAZA benefit in patients
with a suboptimal clinical response to Zolgensma(®) (onasemnogene
abeparvovec) is expected to begin early next year
-- The DEVOTE study evaluating a higher dose of SPINRAZA with the
potential to deliver even greater efficacy in SMA patients of all
ages is progressing
-- New clinical data from the NURTURE and SHINE studies, as well as new
real-world data, further support SPINRAZA's durable efficacy and
established safety profile across SMA patients of all ages
-- TEGSEDI: the only approved at-home subcutaneous therapy for the
treatment of hereditary transthyretin amyloidosis (hATTR) with
polyneuropathy in adult patients
-- Commercially available in 15 countries
-- Reimbursement approved in Portugal, Spain, Italy and Austria
-- Expanding commercial availability in additional EU countries and in
Latin America this year
-- WAYLIVRA: the only approved treatment in the EU for adults with
genetically confirmed familial chylomicronemia syndrome (FCS) at high
risk for pancreatitis
-- Launch progressing in Germany, Austria, Greece and through the ATU
in France; launching in additional EU countries this year
-- Filed for marketing approval in Brazil; refiling new drug
application for U.S. marketing authorization
Second Quarter 2020 and Recent Pipeline Highlights
-- Completed enrollment in the global GENERATION HD1 Phase 3 study of
tominersen in patients with Huntington's disease
-- Progressed multiple neurological disease medicines under Ionis' broad
Biogen collaboration
-- Published data from the Phase 1/2 study of tofersen in the New
England Journal of Medicine
-- Progressed the IONIS-MAPT(Rx) long-term extension study in patients
with Alzheimer's disease and achieved a $12 million milestone
payment
-- Advanced ION464 into a Phase 1/2 study in patients with multiple
system atrophy and achieved an $18 million milestone payment
-- Advanced medicines for the treatment of cancer and immune-mediated GI
disease
-- Licensed ION736 to AstraZeneca for the treatment of cancer and
achieved a $13 million license fee
-- Initiated a Phase 1 study of ION253 for the treatment of
immune-mediated GI disease and achieved a $5 million milestone
payment from Janssen
-- Expanded the Ionis-owned pipeline with the addition of ION363 for the
treatment of FUS-ALS
Upcoming Catalysts
-- Report clinical proof-of-concept results for four or more programs
-- Present positive Phase 2 results from vupanorsen and AKCEA-APOCIII-L(Rx)
-- Initiate a Phase 3 study of AKCEA-APOCIII-L(Rx) in patients with FCS
-- Initiate a registration study of ION363 in patients with FUS-ALS
-- Initiate a Phase 1/2 study of ION541 in patients with sporadic ALS
-- Initiate a Phase 2 study of IONIS-ENaC-2.5(Rx) in patients with chronic
obstructive pulmonary disease (COPD)
-- Initiate a Phase 2 study of IONIS-FXI-L(Rx) in patients with clotting
disorders
-- Initiate a Phase 2 study of IONIS-HBV(Rx) in patients with hepatitis B
virus infection
-- Advance additional new medicines into development
Revenue
Ionis' revenue was comprised of the following (amounts in millions):
Three months ended, Six months ended
June 30,
June 30,
2020 2019 2020 2019
Revenue:
Commercial revenue:
SPINRAZA royalties $72 $71 $138 $130
Product sales, net 16 10 32 17
Licensing and royalty revenue 2 7 4 9
Total commercial revenue 90 88 174 156
R&D Revenue:
Amortization from upfront payments 28 41 49 75
Milestone payments 7 12 30 52
License fees 15 22 15 173
Other services 6 1 11 5
Total R&D revenue 56 76 105 305
Total revenue $146 $164 $279 $461
Operating Expenses
Ionis' operating expenses for the second quarter of 2020 increased compared to the same period in 2019 driven by its investments in advancing its strategic priorities, including advancing the Phase 3 program for AKCEA-TTR-L(Rx) and other medicines in its Ionis-owned pipeline.
Net Loss Attributable to Noncontrolling Interest in Akcea
At June 30, 2020, Ionis owned approximately 76 percent of Akcea. The Company's net loss attributable to noncontrolling interest in Akcea for the second quarter of 2020 was consistent with the same period last year. The line titled "Net loss attributable to noncontrolling interest in Akcea" on Ionis' statement of operations reflects the portion of Akcea's net income or loss attributable to the other owners of Akcea's common stock.
Net Income (Loss) Attributable to Ionis Common Stockholders
Ionis' net loss attributable to Ionis' common stockholders for the second quarter of 2020 was larger compared to the same period in 2019 primarily due to higher revenue and lower operating expenses in the same period last year.
Balance Sheet
Ionis ended June 2020 with cash, cash equivalents and short-term investments of more than $2.3 billion, compared to $2.5 billion at December 31, 2019.
Webcast
Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast to discuss this earnings release and related activities. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address.
About Ionis Pharmaceuticals, Inc.
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 potentially treat a broad range of diseases, including neurological, cardio-renal, metabolic, infectious, and pulmonary diseases.
To learn more about Ionis visit www.ionispharma.com or follow us on twitter @ionispharma.
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 Akcea Therapeutics, Inc., Ionis' majority-owned affiliate. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2019, and the most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to Ionis Pharmaceuticals and its subsidiaries.
Ionis Pharmaceuticals((TM)) is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics(®) is a registered trademark of Akcea Therapeutics, Inc. TEGSEDI(®) is a registered trademark of Akcea Therapeutics, Inc. WAYLIVRA(®) is a registered trademark of Akcea Therapeutics, Inc. SPINRAZA(®) is a registered trademark of Biogen.
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
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,
2020 2019 2020 2019
(unaudited)
Revenue:
Commercial revenue:
SPINRAZA royalties $72 $71 $138 $130
Product sales, net 16 10 32 17
Licensing and royalty revenue 2 7 4 9
Total commercial revenue 90 88 174 156
Research and development revenue under collaborative agreements 56 76 105 305
Total revenue 146 164 279 461
Expenses:
Cost of products sold 3 1 6 2
Research, development and patent 122 106 239 213
Selling, general and administrative 73 76 147 143
Total operating expenses 198 183 392 358
Income (loss) from operations (52) (19) (113) 103
Other income, net 8 2 7 2
Income (loss) before income tax benefit (expense) (44) (17) (106) 105
Income tax benefit (expense) 7 4 (24)
Net income (loss) $(44) $(10) $(102) $81
Net loss attributable to noncontrolling interest in Akcea
Therapeutics, Inc. 12 9 22 3
Net income (loss) attributable to Ionis Pharmaceuticals, Inc.
common stockholders $(32) $(1) $(80) $84
Basic net income (loss) per share $(0.23) $(0.01) $(0.58) $0.62
Diluted net income (loss) per share $(0.23) $(0.01) $(0.58) $0.61
Shares used in computing basic net income (loss) per share 139 140 139 139
Shares used in computing diluted net income (loss) per share 139 140 139 142
IONIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
Condensed Consolidating Statement of Operations
(In Millions)
Six months ended
June 30, 2020
(unaudited)
Ionis
Akcea
Eliminations Ionis
Consolidated
Revenue:
Commercial revenue:
SPINRAZA royalties $
$138
$-
$- $138
Product sales, net 32 32
Licensing and royalty revenue 4 4
Total commercial revenue 142 32 174
Research and development revenue under collaborative agreements 98 7 105
Intercompany revenue 7 (7)
Total revenue 247 39 (7) 279
Expenses:
Cost of products sold 10 (4) 6
Research, development and patent expenses 197 47 (5) 239
Selling, general and administrative 59 88 147
Profit/ loss share for TEGSEDI commercialization activities 10 (10)
Total operating expenses 266 135 (9) 392
Loss from operations (19) (96) 2 (113)
Other income, net 4 3 7
Loss before income tax benefit (15) (93) 2 (106)
Income tax benefit 3 1 4
Net loss $(12) $(92) $2 $(102)
Net loss attributable to noncontrolling interest in Akcea
Therapeutics, Inc.
$-
$- $22 $22
Net loss attributable to Ionis Pharmaceuticals, Inc. common
stockholders $(12) $(92) $24 $(80)
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 Six months ended
June 30,
June 30,
2020 2019 2020 2019
(unaudited)
As reported research, development and
patent expenses according to GAAP $122 $106 $239 $213
Excluding compensation expense related to
equity awards (26) (24) (52) (49)
Non-GAAP research, development and
patent expenses $96 $82 $187 $164
$73 $76 $147 $143
As reported selling, general and
administrative expenses according to
GAAP
Excluding compensation expense related to
equity awards (22) (18) (37) (39)
Non-GAAP selling, general and
administrative expenses $51 $58 $110 $104
$198 $183 $392 $358
As reported operating expenses according
to GAAP
Excluding compensation expense related to
equity awards (48) (42) (89) (87)
Non-GAAP operating expenses $150 $141 $303 $271
As reported income (loss) from operations
according to GAAP $(52) $(19) $(113) $103
Excluding compensation expense related to
equity awards (48) (42) (89) (87)
$(4) $23 $(24) $190
Non-GAAP income (loss) from operations
$(32) $(1) $(80) $84
As reported net income (loss)
attributable to Ionis Pharmaceuticals,
Inc. common stockholders according to
GAAP
Excluding compensation expense related to
equity awards attributable to Ionis
Pharmaceuticals, Inc. common
stockholders (45) (39) (84) (78)
Income tax effect related to compensation
expense related to equity awards
attributable to Ionis Pharmaceuticals,
Inc. common stockholders 5 14 11 13
$8 $24 $(7) $149
Non-GAAP net income (loss) attributable
to Ionis Pharmaceuticals, Inc. common
stockholders according to GAAP
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. common shareholders were adjusted from GAAP to exclude compensation expense related to equity awards and the related tax effect. Compensation expense related to equity awards 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,
2020 2019
(unaudited)
Assets:
Cash,
cash
equivalents
and
short-
term
investments $2,349 $2,500
Contracts
receivable 28 63
Other
current
assets 155 158
Property,
plant and
equipment,
net 173 154
Other
assets 374 358
Total
assets $3,079 $3,233
Liabilities
and
stockholders'
equity:
Other
current
liabilities $132 $155
Current
portion
of
deferred
contract
revenue 100 118
0.125%
convertible
senior
notes 445 435
1%
convertible
senior
notes 284 275
Long-
term
obligations,
less
current
portion 75 75
Long-
term
deferred
contract
revenue 448 490
Total
Ionis
stockholders'
equity 1,377 1,471
Noncontrolling
interest
in Akcea
Therapeutics,
Inc. 218 214
Total
stockholders'
equity $1,595 $1,685
Total
liabilities
and
stockholders'
equity $3,079 $3,233
IONIS PHARMACEUTICALS, INC.
Condensed Consolidating Balance Sheet
(In Millions)
June 30, 2020
(unaudited)
Ionis
Ionis
Akcea
Eliminations
Consolidated
Assets:
Cash, cash equivalents and
short-term investments $1,959 $390
$- $2,349
Contracts receivable 14 14 28
Other current assets 136 24 (5) 155
Property, plant and
equipment, net 167 6 173
Other assets 1,122 94 (842) 374
Total assets $3,398 $528 $(847) $3,079
Liabilities and stockholders'
equity:
Other current liabilities $102 $35 $(5) $132
Current portion of deferred
contract revenue 100 100
0.125% convertible senior
notes 445 445
1% convertible senior notes 284 284
Long-term obligations, less
current portion 61 14 75
Long-term deferred contract
revenue 451 (3) 448
Total stockholders' equity
before noncontrolling
interest 1,955 479 (1,057) 1,377
Noncontrolling interest in
Akcea Therapeutics, Inc. 218 218
Total stockholders' equity $1,955 $479 $(839) $1,595
Total liabilities and
stockholders' equity $3,398 $528 $(847) $3,079
View original content to download multimedia:http://www.prnewswire.com/news-releases/ionis-reports-second-quarter-2020-financial-results-and-recent-business-achievements-301106244.html
SOURCE Ionis Pharmaceuticals, Inc.
