IONS 8-K
Ionis Pharmaceuticals Inc (IONS)
8-K
2021-08-04
For: 2021-08-04
View Original
Added on
April 07, 2026
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): August 4, 2021
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation)
|
|
|
|
(Commission File No.)
|
(IRS Employer Identification No.)
|
(Address of Principal Executive Offices and Zip Code)
Registrant’s telephone number, including area code: (760 ) 931-9200
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions:
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading symbol
|
Name of each exchange on which registered
|
||
|
|
“
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Section 230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Section 240.12b-2 of this chapter).
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 |
Results of Operations and Financial Condition.
|
On August 4, 2021, Ionis Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June
30, 2021. In addition to disclosing results that are determined in accordance with Generally Accepted Accounting Principles (GAAP), the Company also discloses pro forma or non-GAAP results of operations, which are adjusted from GAAP to exclude
non-cash compensation expense related to equity awards, expenses related to the Company’s acquisition of Akcea Therapeutics, Inc. (“Akcea”), and expenses related to the Company’s restructured commercial operations and
the related tax effects. The Company is presenting pro forma information excluding non-cash compensation expense related to equity awards, expenses related to the Akcea acquisition, and expenses related to the restructured commercial operations
and related tax effects because the Company believes it is useful for investors in assessing the Company’s operating results compared to the prior year. A copy of the release is furnished with this report as an exhibit pursuant to “Item 2.02.
Results of Operations and Financial Condition” of Form 8-K in accordance with SEC Release Nos. 33-8216 and 34-47583.
The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general
incorporation language in such filing.
| Item 9.01. |
Financial Statements and Exhibits.
|
(d) Exhibits.
|
Exhibit No.
|
Description
|
|
Press Release dated August 4, 2021.
|
|
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL document).
|
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
|
Ionis Pharmaceuticals, Inc.
|
||
|
Dated: August 4, 2021
|
By: |
/s/ Patrick R. O’Neil
|
|
Patrick R. O’Neil
|
||
|
Executive Vice President, Legal, General Counsel and Chief Compliance Officer
|
||
Exhibit 99.1
Ionis reports second quarter 2021 financial results and recent business achievements
Key Phase 3 milestones move tofersen, eplontersen and pelacarsen closer to the market
Exclusive license to Bicycle Therapeutics’ technology potentially expands LICA technology capabilities
Webcast today, August 4, 2021, at 11:30 a.m. Eastern Time
CARLSBAD, Calif., August 4, 2021 – Ionis
Pharmaceuticals, Inc. (Nasdaq: IONS) today reported its financial results for the second quarter of 2021 and recent business achievements.
“Since our last quarterly update, we continued to execute on our strategic objectives to prepare for multiple Ionis commercial launches, expand our drug
delivery capabilities and advance new products towards the market. Biogen completed dosing in the tofersen Phase 3 VALOR study and began offering tofersen to SOD1-ALS patients on an individual compassionate use basis. We achieved full enrollment in
the eplontersen Phase 3 NEURO-TTRansform study and 50 percent enrollment in the pelacarsen Phase 3 Lp(a) HORIZON study. Additionally, we licensed Bicycle Therapeutics’ technology to expand the capabilities of our LICA technology,” said Brett P. Monia, Ph.D., chief executive officer of Ionis. “Looking ahead, we expect data from multiple pipeline programs, including additional data supporting
the potential for our IONIS-PKK-LRx program to change the standard of care for patients with hereditary angioedema. And by this fall, we expect data from the Phase 3 VALOR study of tofersen in patients with SOD1-ALS. If results from the
VALOR study are positive, we expect tofersen to be our next commercial medicine. These key recent achievements and upcoming catalysts keep us on track for a regular cadence of Phase 3 data and new drug applications, leading to 12 or more products
on the market in 2026.”
| • |
Second quarter results reflect focus on Ionis’ strategic objectives
|
| o |
$126 million in total revenues
|
| o |
$154 million of operating expenses on a non-GAAP basis(1) and $199 million on a GAAP basis
|
| o |
Net loss of $36 million on a non-GAAP basis(1) and $81 million on a GAAP basis
|
| • |
“In addition to advancing our pipeline and expanding our drug discovery capabilities, we have taken multiple steps to streamline our operations in
support of our wholly owned medicines. We have completed the integration of Akcea, entered distribution arrangements with Sobi and restructured our commercial
operations. These steps enabled us to unlock significant resources that we are redirecting towards our highest priority programs,” said Elizabeth L. Hougen, chief financial officer of Ionis. “We remain on track to achieve our 2021 revenue guidance of more than $600 million. We continue to expect increased R&D revenue in the second half of this year. Already in the third quarter, we earned $25
million from Novartis for the pelacarsen enrollment milestone. We are revising our 2021 operating expense and net loss guidance because of our license of Bicycle’s technology. Importantly, we remain well-capitalized with the resources we need to
achieve our strategic objectives.”
1
Revised 2021 Financial Guidance
| • |
Updated operating expense and net loss guidance because of Ionis’ license of Bicycle’s technology(1)
|
|
Prior 2021 Guidance
|
Revised 2021 Guidance
|
|
|
Revenue
|
>$600 million
|
Unchanged
|
|
Operating Expenses (1)
|
$675 million to $725 million
|
$710 million to $750 million
|
|
Net Loss (1)
|
<$75 million
|
<$110 million
|
| (1) |
All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards and expenses related to the Akcea acquisition
and restructured commercial operations and the related tax effects. Please refer to the section below titled “Financial Impacts of Akcea Acquisition and Restructured Commercial Operations” for a summary of the costs specific to these
transactions. Additionally, please refer to the detailed reconciliation of non-GAAP and GAAP measures, which is provided later in this release.
|
| • |
SPINRAZA®: The global market leader for the treatment of spinal muscular atrophy (SMA) patients of all ages
|
| o |
$500 million in worldwide sales in the second quarter
|
| o |
More than 11,000 patients worldwide on therapy at the end of the second quarter across commercial, expanded access and clinical trial settings
|
| o |
New data presented at CureSMA reinforce the potential for higher-dose SPINRAZA to improve SMA patient outcomes and further support SPINRAZA’s potential long-term
benefit for SMA patients of all ages
|
| • |
| o |
Successfully completed the transition of North American TEGSEDI operations to Swedish Orphan Biovitrum AB (Sobi)
|
Second Quarter 2021 and Recent Events
| • |
Phase 3 Pipeline: Six Phase 3 studies on track for a regular cadence of data readouts beginning this year
|
| o |
Completed dosing in the Phase 3 VALOR study of tofersen in patients with SOD1-ALS, with data expected by this fall
|
| ◾ |
Opened individual compassionate use access for SOD1-ALS patients with the most rapidly progressive disease
|
| o |
Achieved full enrollment in the Phase 3 NEURO-TTRansform study of eplontersen in patients with TTR polyneuropathy, with data expected by mid-2022
|
| o |
Achieved 50 percent enrollment in the Phase 3 Lp(a) HORIZON study of pelacarsen for patients at risk for Lp(a)-driven cardiovascular disease, resulting in a $25
million payment from Novartis
|
| o |
Advanced ION363 into a Phase 3 study in patients with FUS-ALS
|
| • |
Mid-stage Pipeline: multiple medicines with potential to change the standard of care for patients with severe diseases
|
| o |
Continued to advance the Phase 2b RE-THINc ESRD study of IONIS-FXI-LRx, with data expected in the first half of 2022
|
| o |
Reported data from the Phase 1/2 study of IONIS-MAPTRx in patients with Alzheimer’s disease, demonstrating durable, time and dose-dependent reductions in
CSF tau protein; IONIS-MAPTRx was generally well tolerated
|
| o |
Advanced the ongoing Phase 2 study of ION541 in patients with ALS regardless of family history, resulting in a $10 million payment from Biogen
|
| o |
Advanced ION224 into a Phase 2b study in patients with non-alcoholic steatohepatitis (NASH)
|
| o |
Advanced ION373 into the Phase 2 portion of a pivotal study in patients with Alexander disease
|
2
| • |
Strategic and Business Events
|
| o |
Entered a license agreement with Bicycle Therapeutics for exclusive rights to Bicycle’s peptide technology to expand the capabilities of Ionis’ LICA technology
|
| o |
Announced changes to the Ionis board of directors
|
| ◾ |
Joseph Loscalzo, M.D., Ph.D., appointed as chairman and Allene M. Diaz as a member of the board
|
| ◾ |
Joseph Wender appointed as lead independent director
|
| ◾ |
Ionis founder and executive chairman, Stanley T. Crooke M.D., Ph.D. and Breaux B. Castleman retired from the board
|
Upcoming 2021 Pipeline Catalysts(2)
|
Anticipated Key 2021 Data Readouts
|
|||||||
|
Program
|
Phase
|
Anticipated Indication
|
H1
|
H2
|
|||
|
IONIS-PKK-LRx
|
2
|
Hereditary angioedema (top-line data)
|
 |
||||
|
IONIS-AGT-LRx
|
2
|
Hypertension
|
|
||||
|
Tominersen
|
3
|
Huntington’s disease
|
|
||||
|
IONIS-ENAC-2.5Rx
|
2
|
Cystic fibrosis
|
|
||||
|
IONIS-MAPTRx
|
1/2
|
Alzheimer’s disease
|
|
||||
|
Tofersen
|
3 (VALOR)
|
SOD1-ALS
|
•
|
||||
|
Vupanorsen
|
2b
|
sHTG/CVD risk reduction
|
•
|
||||
|
IONIS-PKK-LRx
|
2
|
Hereditary angioedema (full data)
|
•
|
||||
|
IONIS-GHR-LRx
|
2 + OLE
|
Acromegaly
|
•
|
||||
Anticipated Key 2021 Study Initiations
|
Program
|
Phase
|
Anticipated Indication
|
H1
|
H2
|
|||
|
SPINRAZA
|
4 (RESPOND)
|
SMA, suboptimal gene therapy response
|
|
||||
|
Tofersen
|
3 (ATLAS)
|
Presymptomatic SOD1-ALS
|
|
||||
|
ION363
|
3
|
FUS-ALS
|
|
||||
|
IONIS-AGT-LRx
|
2b
|
Resistant hypertension
|
|
||||
|
IONIS-AGT-LRx
|
2
|
Heart failure with reduced ejection fraction
|
|
||||
|
ION373
|
2/3
|
Alexander disease
|
|
||||
|
ION224
|
2b
|
NASH
|
|
||||
|
IONIS-APOCIII-LRx
|
3
|
Second TG indication (sHTG)
|
•
|
||||
|
ION582
|
2
|
Angelman Syndrome
|
•
|
(2) Timing of partnered program catalysts based on partners’ most recent publicly available disclosures
Second Quarter 2021 Financial Results
Revenue
Ionis' revenue was comprised of the following (amounts in millions):
|
Three months ended,
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
Revenue:
|
||||||||||||||||
|
Commercial revenue:
|
||||||||||||||||
|
SPINRAZA royalties
|
$
|
72
|
$
|
72
|
$
|
132
|
$
|
138
|
||||||||
|
TEGSEDI and WAYLIVRA revenue, net
|
12
|
16
|
31
|
32
|
||||||||||||
|
Licensing and royalty revenue
|
2
|
2
|
7
|
4
|
||||||||||||
|
Total commercial revenue
|
86
|
90
|
170
|
174
|
||||||||||||
|
R&D Revenue:
|
||||||||||||||||
|
Amortization from upfront payments
|
20
|
28
|
40
|
49
|
||||||||||||
|
Milestone payments
|
15
|
7
|
20
|
30
|
||||||||||||
|
License fees
|
-
|
15
|
-
|
15
|
||||||||||||
|
Other services
|
5
|
6
|
7
|
11
|
||||||||||||
|
Total R&D revenue
|
40
|
56
|
67
|
105
|
||||||||||||
|
Total revenue
|
$
|
126
|
$
|
146
|
$
|
237
|
$
|
279
|
||||||||
3
In the second quarter of 2021, the Company successfully completed the transition of its TEGSEDI operations in North America to Sobi. As a result, the Company’s commercial revenue from product sales shifted to distribution fees based on net sales generated by Sobi.
The Company’s R&D revenue decreased in the second quarter of 2021 compared to the same period last year primarily because the Company earned more
milestone payments in the second quarter of 2020 than the same period this year. The Company expects its R&D revenue to increase in the second half of 2021 compared to the first half as its partnered programs advance. Already in the third quarter of 2021, the Company earned a $25 million milestone payment from Novartis when Novartis achieved 50 percent enrollment in the Phase 3 Lp(a) HORIZON study
of pelacarsen.
Financial Impacts of Akcea Acquisition and Restructured Commercial Operations
In the second quarter of 2021, the Company incurred $15 million of costs in conjunction with the Akcea acquisition and restructuring of the Company’s
commercial operations. The Company excluded these costs from its non-GAAP amounts for the period. Refer to the detailed reconciliation of non-GAAP and GAAP measures that is provided later in this release.
Operating Expenses
Ionis’ operating expenses for the second quarter of 2021 increased slightly compared to the same period last year driven by an increase in R&D
expenses, partially offset by a decrease in SG&A expenses. Ionis’ increased R&D expenses were primarily driven by the Company’s investments in advancing its late-stage wholly owned pipeline. Ionis’ decreased
SG&A expenses were primarily from operating efficiencies achieved from integrating Akcea and restructuring the Company’s commercial operations.
Net Loss Attributable to Ionis Common Stockholders
Ionis’ net loss attributable to Ionis’ common stockholders for the second quarter of 2021 increased compared to the same period in the prior year for the
reasons discussed above. Additionally, the Company recognized an $8.6 million non-cash loss from the early retirement of a significant portion of its 1 percent senior convertible notes.
Balance Sheet
Ionis ended June 2021 with cash, cash equivalents and short-term investments of $2.1 billion, compared to $1.9 billion at
December 31, 2020. In April 2021, Ionis issued $632.5 million of 0 percent senior convertible notes due in April 2026 and repurchased $247.9 million of its 1
percent senior convertible notes. The Company’s remaining $62 million of 1 percent senior convertible notes mature in November 2021.
The Company revised its 2020 amounts to reflect the simplified convertible instruments guidance the Company adopted retrospectively on January 1, 2021.
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.
4
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing the standards of care with
its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the
knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.
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. 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 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, 2020, 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™ 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:
760-603-2331
Roslyn Patterson
Vice President, Marketing and Communications
760-603-2681
5
IONIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
Condensed Consolidated Statements of Operations
(In Millions, Except Per Share Data)
|
Three months ended, ended,
June 30,
|
Six months ended,
June 30,
|
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
(as revised*)
|
(as revised*)
|
|||||||||||||||
|
(unaudited)
|
||||||||||||||||
|
Revenue:
|
||||||||||||||||
|
Commercial revenue:
|
||||||||||||||||
|
SPINRAZA royalties
|
$
|
72
|
$
|
72
|
$
|
132
|
$
|
138
|
||||||||
|
TEGSEDI and WAYLIVRA revenue, net
|
12
|
16
|
31
|
32
|
||||||||||||
|
Licensing and royalty revenue
|
2
|
2
|
7
|
4
|
||||||||||||
|
Total commercial revenue
|
86
|
90
|
170
|
174
|
||||||||||||
|
Research and development revenue under collaborative agreements
|
40
|
56
|
67
|
105
|
||||||||||||
|
Total revenue
|
126
|
146
|
237
|
279
|
||||||||||||
|
Expenses:
|
||||||||||||||||
|
Cost of sales
|
3
|
3
|
6
|
6
|
||||||||||||
|
Research, development and patent
|
139
|
122
|
279
|
239
|
||||||||||||
|
Selling, general and administrative
|
57
|
73
|
117
|
147
|
||||||||||||
|
Total operating expenses
|
199
|
198
|
402
|
392
|
||||||||||||
|
Loss from operations
|
(73
|
)
|
(52
|
)
|
(165
|
)
|
(113
|
)
|
||||||||
|
Other income (expense):
|
||||||||||||||||
|
Loss on early retirement of debt
|
(8
|
)
|
-
|
(8
|
)
|
-
|
||||||||||
|
Other income, net
|
-
|
17
|
3
|
25
|
||||||||||||
|
Loss before income tax (expense) benefit
|
(81
|
)
|
(35
|
)
|
(170
|
)
|
(88
|
)
|
||||||||
|
Income tax (expense) benefit
|
-
|
(3
|
)
|
(1
|
)
|
1
|
||||||||||
|
Net loss
|
$
|
(81
|
)
|
$
|
(38
|
)
|
$
|
(171
|
)
|
$
|
(87
|
)
|
||||
|
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc.
|
-
|
12
|
-
|
22
|
||||||||||||
|
Net loss attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(81
|
)
|
$
|
(26
|
)
|
$
|
(171
|
)
|
$
|
(65
|
)
|
||||
|
Basic and diluted net loss per share
|
$
|
(0.57
|
)
|
$
|
(0.18
|
)
|
$
|
(1.21
|
)
|
$
|
(0.47
|
)
|
||||
|
Shares used in computing basic and diluted net loss per share
|
141
|
139
|
141
|
139
|
||||||||||||
*The Company revised its 2020 amounts to reflect the simplified convertible instruments guidance the Company adopted retrospectively on January 1, 2021.
6
IONIS PHARMACEUTICALS, INC.
Reconciliation of GAAP to Non-GAAP Basis:
Condensed Consolidated Operating Expenses, Loss From Operations, and Net Income (Loss)
(In Millions)
|
Three months ended,
June 30,
|
Six months ended,
June 30,
|
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
(as revised*)
|
(as revised*)
|
|||||||||||||||
|
(unaudited)
|
||||||||||||||||
|
As reported research, development and patent expenses according to GAAP
|
$
|
139
|
$
|
122
|
$
|
279
|
$
|
239
|
||||||||
|
Excluding compensation expense related to equity awards
|
(23
|
)
|
(26
|
)
|
(49
|
)
|
(52
|
)
|
||||||||
|
Excluding Akcea acquisition and restructured commercial operation costs
|
(4
|
)
|
-
|
(6
|
)
|
-
|
||||||||||
|
Non-GAAP research, development and patent expenses
|
$
|
112
|
$
|
96
|
$
|
224
|
$
|
187
|
||||||||
|
As reported selling, general and administrative expenses according to GAAP
|
$
|
57
|
$
|
73
|
$
|
117
|
$
|
147
|
||||||||
|
Excluding compensation expense related to equity awards
|
(7
|
)
|
(22
|
)
|
(19
|
)
|
(37
|
)
|
||||||||
|
Excluding Akcea acquisition and restructured commercial operation costs
|
(11
|
)
|
-
|
(16
|
)
|
-
|
||||||||||
|
Non-GAAP selling, general and administrative expenses
|
$
|
39
|
$
|
51
|
$
|
82
|
$
|
110
|
||||||||
|
As reported operating expenses according to GAAP
|
$
|
199
|
$
|
198
|
$
|
402
|
$
|
392
|
||||||||
|
Excluding compensation expense related to equity awards
|
(30
|
)
|
(48
|
)
|
(68
|
)
|
(89
|
)
|
||||||||
|
Excluding Akcea acquisition and restructured commercial operation costs
|
(15
|
)
|
-
|
(22
|
)
|
-
|
||||||||||
|
Non-GAAP operating expenses
|
$
|
154
|
$
|
150
|
$
|
312
|
$
|
303
|
||||||||
|
As reported loss from operations according to GAAP
|
$
|
(73
|
)
|
$
|
(52
|
)
|
$
|
(165
|
)
|
$
|
(113
|
)
|
||||
|
Excluding compensation expense related to equity awards
|
(30
|
)
|
(48
|
)
|
(68
|
)
|
(89
|
)
|
||||||||
|
Excluding Akcea acquisition and restructured commercial operation costs
|
(15
|
)
|
-
|
(22
|
)
|
-
|
||||||||||
|
Non-GAAP loss from operations
|
$
|
(28
|
)
|
$
|
(4
|
)
|
$
|
(75
|
)
|
$
|
(24
|
)
|
||||
|
As reported net loss attributable to Ionis Pharmaceuticals, Inc. common stockholders
according to GAAP
|
$
|
(81
|
)
|
$
|
(26
|
)
|
$
|
(171
|
)
|
$
|
(65
|
)
|
||||
|
Excluding compensation expense related to equity awards attributable to Ionis Pharmaceuticals, Inc. common
stockholders
|
(30
|
)
|
(45
|
)
|
(68
|
)
|
(84
|
)
|
||||||||
|
Excluding Akcea acquisition and restructured commercial operation costs
|
(15
|
)
|
-
|
(22
|
)
|
-
|
||||||||||
|
Income tax effect related to compensation expense related to equity awards attributable to Ionis
Pharmaceuticals, Inc. common stockholders
|
-
|
4
|
-
|
12
|
||||||||||||
|
Non-GAAP net income (loss) attributable to Ionis Pharmaceuticals, Inc. common
stockholders according to GAAP
|
$
|
(36
|
)
|
$
|
15
|
$
|
(81
|
)
|
$
|
7
|
||||||
*The Company revised its 2020 amounts to reflect the simplified convertible instruments guidance the Company adopted retrospectively on January 1, 2021.
7
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 stockholders were adjusted from GAAP to exclude compensation expense related to equity awards and costs related to the Akcea acquisition and restructured commercial
operations and the related tax effects. Compensation expense related to equity awards are non-cash. Costs related to the Akcea acquisition and restructured commercial operations include: severance costs, retention costs and other costs related to
commercial operations. 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.
8
IONIS PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(In Millions)
|
June 30,
2021
|
December 31,
2020
|
|||||||
|
(as revised*)
|
||||||||
|
(unaudited)
|
||||||||
|
Assets:
|
||||||||
|
Cash, cash equivalents and short-term investments
|
$
|
2,059
|
$
|
1,892
|
||||
|
Contracts receivable
|
24
|
76
|
||||||
|
Other current assets
|
155
|
162
|
||||||
|
Property, plant and equipment, net
|
179
|
181
|
||||||
|
Other assets
|
80
|
79
|
||||||
|
Total assets
|
$
|
2,497
|
$
|
2,390
|
||||
|
Liabilities and stockholders’ equity:
|
||||||||
|
Other current liabilities
|
$
|
130
|
$
|
183
|
||||
|
Current portion of 1% convertible senior notes, net
|
62
|
309
|
||||||
|
Current portion of deferred contract revenue
|
102
|
108
|
||||||
|
0% convertible senior
notes, net
|
617
|
-
|
||||||
|
0.125% convertible senior notes, net
|
541
|
540
|
||||||
|
Long-term obligations, less current portion
|
82
|
83
|
||||||
|
Long-term deferred contract revenue
|
380
|
424
|
||||||
|
Total stockholders’ equity
|
583
|
743
|
||||||
|
Total liabilities and stockholders’ equity
|
$
|
2,497
|
$
|
2,390
|
||||
*The Company revised its 2020 amounts to reflect the simplified convertible instruments guidance the Company adopted retrospectively on January 1, 2021.
9