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Ionis Pharmaceuticals, Inc.

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Msg  61494 of 61511  at  11/4/2020 7:03:02 AM  by

movin_on_again

The following message was updated on 11/4/2020 7:03:46 AM.

Ionis reports third quarter 2020 financial results and recent business achievementsOn track to achieve 2020 financial guidanceAkcea acquisition supports Ionis' commercial strategyWebcast today,

  
CARLSBAD, Calif., Nov. 4, 2020 /PRNewswire/ -- Ionis Pharmaceuticals, Inc.  
(Nasdaq: IONS) today reported its financial results for the third quarter of
2020 and recent business highlights.

"We took an important step forward in our evolution when we acquired Akcea.
This transaction supports our commercial strategy, further enabling us to
maximize the value of our Ionis-owned pipeline. As one company, we believe we
are stronger and more efficient, with an enhanced ability to achieve even
greater future success," said Brett P. Monia, Ph.D., chief executive officer at
Ionis. "We made significant progress across our pipeline this year. Recently,
we advanced inhaled delivery with IONIS-ENAC-2.5Rx, positioning us to bring new
treatment options to patients with pulmonary diseases. We also initiated
mid-stage studies for vupanorsen in cardiovascular disease patients and ION541,
our medicine to treat nearly all forms of ALS. Additionally, our five Phase 3
studies continue to progress, with our sixth expected to begin by the end of
this year. We believe our achievements this year move us closer to delivering
10 or more marketing applications through 2025. Our goal is to bring these
medicines to millions of patients around the world."

Third Quarter 2020 Financial Results and Highlights

* On track to achieve financial guidance of being meaningfully profitable
this year
* Net income of $5 million on a non-GAAP basis and a net loss of $31
million on a GAAP basis for the third quarter

* Achieved quarter over quarter revenue growth
* Commercial revenue from SPINRAZA(r) (nusinersen) royalties of $74
million, in line with the prior quarter
* Product sales from TEGSEDI(r) (inotersen) and WAYLIVRA(r) (volanesorsen)
increased more than 15 percent
* R&D revenue increased more than 15 percent from advancing several
partnered programs

* Maintained a strong balance sheet with cash of $2.3 billion
* Estimated pro forma cash following the Akcea acquisition of $1.8 billion


"Our acquisition of Akcea further strengthens our business and financial
position in numerous ways. We now retain more value from Akcea's rich pipeline
and commercial products. We are also able to use Akcea's current cash and
future cash flows to advance Ionis' strategic priorities. And beginning next
year, we expect to realize meaningful cost synergies as we continue to
integrate the two companies," said Elizabeth L. Hougen, chief financial officer
of Ionis. "Looking ahead, we are maintaining our 2020 financial guidance driven
by the significant revenue and earnings growth we expect in the fourth quarter.
We have already earned revenue from multiple sources this quarter, including
$75 million from Pfizer for advancing vupanorsen. Importantly, we remain well
capitalized with the financial resources to achieve our strategic goals."

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 third quarter
* More than 11,000 patients were on SPINRAZA treatment worldwide at the
end of the third quarter, including patients across commercial, expanded access
and clinical trial settings
* The open-label safety cohort of the DEVOTE study of higher-dose SPINRAZA
is fully enrolled and the pivotal randomized treatment cohort will begin
enrolling patients next
* The Phase 4 RESPOND study in patients with a suboptimal clinical
response to gene therapy is expected to begin early next year

* 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
* Secured pricing and reimbursement in multiple new EU markets and in
Canada in the largest provinces and with multiple private payers
* Won 2020 Prix Galien USA Award for the Best Biotechnology Product

* WAYLIVRA: the only approved treatment in the EU for adults with
genetically confirmed familial chylomicronemia syndrome (FCS) at high risk for
pancreatitis
* Commercially available in 4 countries
* Finalized pricing negotiations in additional EU markets, including in
the UK


Third Quarter 2020 and Recent Pipeline Highlights

* Positive Phase 2 vupanorsen and AKCEA-APOCIII-LRx results presented at
the European Society of Cardiology annual meeting
* Advanced multiple programs into key mid-stage studies
* Vupanorsen advanced into Phase 2b development with the initiation of the
TRANSLATE-TIMI 70 dose-ranging study in statin-treated patients with
dyslipidemia, resulting in a $75 million payment from Pfizer
* IONIS-FXI-LRx advanced into Phase 2b development in patients with
end-stage renal disease
* IONIS-HBVRx advanced into Phase 2b development in patients with
hepatitis B virus infection

* Advanced inhaled delivery
* Positive IONIS-ENAC-2.5Rx healthy volunteer results provided support for
inhaled antisense medicine delivery
* Dosing completed in the IONIS-ENAC-2.5Rx Phase 2 study in patients with
cystic fibrosis

* Advanced the IONIS-PKK-LRx program
* Proof-of-concept data from the PKK development program in patients with
hereditary angioedema were reported in the New England Journal of Medicine
* Enrollment completed in the IONIS-PKK-LRx Phase 2 study in patients with
hereditary angioedema
* IONIS-PKK-LRx advanced into an investigator-initiated study in
hospitalized COVID-19 patients in Brazil

* Progressed multiple neurological disease medicines under Ionis' broad
collaboration with Biogen, earning more than $50 million
* ION541 advanced into Phase 1/2 development in patients with nearly all
forms of ALS
* ION464 advanced into Phase 1/2 development in patients with multiple
system atrophy
* IONIS-MAPTRx continued to advance in a long-term extension study in
patients with Alzheimer's disease

* The U.S. FDA granted orphan drug designation to Ionis-owned medicines
for people with Alexander disease, -thalassemia and Lafora diseases

Upcoming Catalysts

* Report clinical data, potentially enabling key programs to advance
towards the market:
* Subcutaneous and orally delivered ION449 targeting PCSK9 at the American
Heart Association Scientific Sessions 2020
* IONIS-AGT-LRx Phase 2 studies in patients with hypertension
* IONIS-ENAC-2.5Rx Phase 2 study in patients with cystic fibrosis
* IONIS-GHR-LRx Phase 2 study in patients with acromegaly
* IONIS-PKK-LRx Phase 2 study in patients with hereditary angioedema

* Advance the pipeline with numerous study initiations:
* AKCEA-APOCIII-LRx Phase 3 study in patients with FCS
* ION363 registrational study in patients with FUS-ALS
* IONIS-ENAC-2.5Rx Phase 2 study in patients with chronic obstructive
pulmonary disease
* Phase 1/2 studies of Ionis-owned medicines:
* ION251 for patients with multiple myeloma
* ION373 for patients with Alexander disease
* ION716 for patients with Prion diseases


* Expand TEGSEDI and WAYLIVRA commercial availability in the EU and Latin
America
* Refile the WAYLIVRA application for marketing authorization in the U.S.
next year

Revenue

Ionis' revenue was comprised of the following (amounts in millions):

Three months ended, Nine months ended,

September 30, September 30,

2020 2019 2020 2019

Revenue:

Commercial revenue:

SPINRAZA royalties $74 $82 $212 $212

Product sales, net 19 12 51 29

Licensing and royalty revenue 2 2 6 11

Total commercial revenue 95 96 269 252

R&D Revenue:

Amortization from upfront payments 19 23 68 100

Milestone payments 44 12 73 64

License fees - 26 15 198

Other services 2 11 14 15

Total R&D revenue 65 72 170 377

Total revenue $160 $168 $439 $629

Operating Expenses

Ionis' operating expenses for the third quarter of 2020 increased compared
to the same period in 2019 driven by the Company's investments in advancing the
Phase 3 program for AKCEA-TTR-LRx and other medicines in its Ionis-owned
pipeline.

Net Loss Attributable to Noncontrolling Interest in Akcea

Prior to completing its acquisition of Akcea in October 2020, Ionis owned
approximately 76 percent of Akcea. 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. In October 2020, after the acquisition of Akcea closed,
Ionis no longer recognizes any noncontrolling interest in Akcea on its
statement of operations.

Net Income (Loss) Attributable to Ionis Common Stockholders

Ionis recognized a net loss attributable to Ionis' common stockholders for
the third quarter of 2020 compared to net income in the same period in 2019
primarily due to higher revenue in 2019, including a $150 million license fee
Ionis earned from Novartis. Additionally, Ionis' operating expenses increased
in 2020 compared to the same period last year as described above.

Balance Sheet

Ionis ended September 2020 with cash, cash equivalents and short-term
investments of more than $2.3 billion, compared to $2.5 billion at December 31,
2019. In October 2020, Ionis used approximately $545 million of its cash for
the Akcea acquisition.

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' wholly owned subsidiary. 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
 
 


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