Media
“With two commercial products on the market, the initiation of two Phase 3 programs, and two drugs in our pipeline with positive Phase 2 data, 2019 was a successful year for Akcea and our patients. We have a solid foundation in place for future clinical and commercial achievements, which includes ongoing efforts to potentially expand our pipeline,” said
“With the commercial launches of TEGSEDI and WAYLIVRA in additional countries, we generated total product revenues of
Upcoming Events
- Launch of TEGSEDI in additional E.U. countries, and through PTC Therapeutics in
Latin America - Launch of WAYLIVRA in additional E.U. countries, and potential approval in
Brazil through PTC Therapeutics - Announce detailed development plans for AKCEA-APOCIII-LRx and advance into Phase 3 study for
FCS , plus potentially other indications - Present Phase 2 results of AKCEA-APOCIII-LRx and AKCEA-ANGPTL3-LRx at a medical meeting
- Update regarding WAYLIVRA® (volanesorsen) in the
U.S. with a goal of re-filing with theFood and Drug Administration , or FDA, this year - Work with Ionis to potentially license an additional medicine into the Akcea pipeline
Recent Business Updates
- Strengthened the management team by appointing
Alex Howarth as Chief Operating Officer and promotingKyle Jenne to Chief Commercial Officer - Appointed
Lynne Parshall , J.D. as Chairman of the Board, and addedBarbara Yanni and Dr.Amber Saltzman to the board of directors - Licensed worldwide rights to Pfizer, Inc. for AKCEA-ANGPTL3-LRx
- Retained the rights to AKCEA-APOCIII-LRx which the company intends to develop in rare disease and potentially broader cardiovascular disease indications
Full Year 2019 Commercial Achievements
- Achieved total product sales of
$42 million in 2019 including$14 million in Q4, achieving consistent quarter over quarter growth - Made TEGSEDI commercially available in over 10 countries
- Shipped commercial TEGSEDI in
Canada ; successfully received positive listing recommendation from both Health Technology Assessment, or HTA, bodies inCanada - Continued launch of WAYLIVRA in
Germany and inFrance through the ATU, or reimbursed early access program - PTC Therapeutics announced approval of TEGSEDI in
Brazil inOctober 2019 ; with this achievement, Akcea earned a$4 million milestone payment which was split 60% to Ionis and 40% to Akcea per the TEGSEDI agreement
Recent Pipeline Achievements
- Reported positive top line results from the Phase 2 study of AKCEA-APOCIII-LRx
- Reported positive top line results from the Phase 2 study of AKCEA-ANGPTL3- LRx
- Initiated the NEURO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with polyneuropathy driven by hereditary TTR amyloidosis. Find more info at www.neuro-ttransform.com
- Initiated the CARIO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with TTR-mediated amyloid cardiomyopathy. Find more info at www.cardio-ttransform.com
- Reported positive top line results from the Phase 1 study of AKCEA-TTR-LRx
- Published results in the New England Journal of Medicine from the Phase 2 study of AKCEA-APO(a)-LRx in patients with Lp(a)-driven cardiovascular disease
- Novartis treated first patients in Phase 3 trial for AKCEA-APO(a)-LRx
Financial Results
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.
Revenue
Akcea’s total revenue for the fourth quarter and year ended
Expenses
Akcea’s operating expenses, net of the reimbursement due from Ionis through the companies’ profit/loss share arrangement, for the fourth quarter and year ended
Net Income/Loss
Akcea reported net income of $82 million and
For the fourth quarter and year ended
Balance Sheet
As of
Conference Call
At
ABOUT
FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the business of
In this press release, unless the context requires otherwise, “Ionis”, “Akcea,” “Company,” “Companies,” “we,” “our,” and “us” refers to
Ionis Pharmaceuticals™ is a trademark of
AKCEA THERAPEUTICS INC. SELECTED FINANCIAL INFORMATION Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Data) |
||||||||||||||||
Three Months Ended December 31, |
Years Ended December 31, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenue: | ||||||||||||||||
Product revenue, net | $ | 13,690 | $ | 2,237 | $ | 42,253 | $ | 2,237 | ||||||||
Licensing revenue | 4,000 | - | 10,172 | 12,000 | ||||||||||||
Total commercial revenue | 17,690 | 2,237 | 52,425 | 14,237 | ||||||||||||
Research and development and license revenue under collaborative agreements | 259,790 | 7,960 | 436,118 | 50,630 | ||||||||||||
Total revenue | 277,480 | 10,197 | 488,543 | 64,867 | ||||||||||||
Expenses: | ||||||||||||||||
Cost of sales and license | 5,031 | 2,789 | 15,659 | 11,733 | ||||||||||||
Research and development | 148,165 | 33,532 | 292,852 | 130,340 | ||||||||||||
Selling, general and administrative | 51,434 | 45,934 | 181,681 | 153,610 | ||||||||||||
Net loss share from commercial activities under arrangement with |
(10,313 | ) | - | (39,723 | ) | - | ||||||||||
Total expenses | 194,317 | 82,255 | 450,469 | 295,683 | ||||||||||||
Income (loss) from operations | 83,163 | (72,058 | ) | 38,074 | (230,816 | ) | ||||||||||
Other income (expense): | ||||||||||||||||
Investment income | 1,223 | 1,542 | 5,505 | 5,631 | ||||||||||||
Other expense | (339 | ) | (41 | ) | (615 | ) | (189 | ) | ||||||||
Income (loss) before income tax expense | 84,047 | (70,557 | ) | 42,964 | (225,374 | ) | ||||||||||
Income tax expense | (1,641 | ) | - | (2,192 | ) | (447 | ) | |||||||||
Net income (loss) | $ | 82,406 | $ | (70,557 | ) | $ | 40,772 | $ | (225,821 | ) | ||||||
Net income (loss) per share of common stock owned by Ionis, basic | $ | 0.87 | $ | (0.79 | ) | $ | 0.49 | $ | (2.74 | ) | ||||||
Weighted-average shares of common stock outstanding owned by Ionis, basic |
71,342 | 67,130 | 70,100 | 59,812 | ||||||||||||
Net income (loss) per share of common stock owned by others, basic | $ | 0.87 | $ | (0.79 | ) | $ | 0.29 | $ | (2.87 | ) | ||||||
Weighted-average shares of common stock outstanding owned by others, basic |
23,723 | 21,870 | 22,816 | 21,553 | ||||||||||||
Net income (loss) per share of common stock owned by Ionis, diluted | $ | 0.86 | $ | (0.79 | ) | $ | 0.48 | $ | (2.74 | ) | ||||||
Weighted-average shares of common stock outstanding owned by Ionis, diluted |
71,342 | 67,130 | 70,100 | 59,812 | ||||||||||||
Net income (loss) per share of common stock owned by others, diluted | $ | 0.86 | $ | (0.79 | ) | $ | 0.29 | $ | (2.87 | ) | ||||||
Weighted-average shares of common stock outstanding owned by others, diluted |
24,863 | 21,870 | 25,282 | 21,553 | ||||||||||||
AKCEA THERAPEUTICS INC. Reconciliation of GAAP to Non-GAAP Basis: Condensed Consolidated Operating Expenses, Income (Loss) from Operations, and Net Income (Loss) (In Thousands) |
||||||||||||||||
Three Months Ended December 31, |
Years Ended December 31, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
As reported operating expenses according to GAAP | $ | 194,317 | $ | 82,255 | $ | 450,469 | $ | 295,683 | ||||||||
Excluding compensation expense related to equity awards | 7,653 | 13,043 | 37,112 | 44,282 | ||||||||||||
Non-GAAP operating expenses | $ | 186,664 | $ | 69,212 | $ | 413,357 | $ | 251,401 | ||||||||
As reported income (loss) from operations according to GAAP | $ | 83,163 | $ | (72,058 | ) | $ | 38,074 | $ | (230,816 | ) | ||||||
Excluding compensation expense related to equity awards | 7,653 | 13,043 | 37,112 | 44,282 | ||||||||||||
Non-GAAP income (loss) from operations | $ | 90,816 | $ | (59,015 | ) | $ | 75,186 | $ | (186,534 | ) | ||||||
As reported net income (loss) according to GAAP | $ | 82,406 | $ | (70,557 | ) | $ | 40,772 | $ | (225,821 | ) | ||||||
Excluding compensation expense related to equity awards | 7,653 | 13,043 | 37,112 | 44,282 | ||||||||||||
Income tax effect related to compensation expense related to equity awards | (394 | ) | - | (394 | ) | - | ||||||||||
Non-GAAP net income (loss) | $ | 89,665 | $ | (57,514 | ) | $ | 77,490 | $ | (181,539 | ) |
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) were adjusted from GAAP to exclude compensation expense related to equity awards, which are non-cash expenses. Akcea 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. Akcea 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 Akcea’s non-GAAP results is consistent with how Akcea’s management internally evaluates the performance of its operations.
Condensed Consolidated Balance Sheets (In Thousands) |
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December 31, | ||||||
2019 | 2018 | |||||
(unaudited) | (unaudited) | |||||
Assets: | ||||||
Cash and cash equivalents | 306,866 | 86,454 | ||||
Short-term investments | 156,806 | 166,155 | ||||
Accounts receivable | 10,496 | 4,597 | ||||
Receivable from |
3,231 | - | ||||
Inventories | 8,817 | 85 | ||||
Other current assets | 10,689 | 9,944 | ||||
Property, plant and equipment, net | 5,261 | 5,696 | ||||
Operating lease right-of-use assets | 11,094 | - | ||||
Intangible assets, net | 83,051 | 88,914 | ||||
Deposits and other assets | 2,939 | 3,416 | ||||
Total assets | 599,250 | 365,261 | ||||
Liabilities and stockholders' equity | ||||||
Accounts payable | 10,216 | 12,068 | ||||
Payable to |
- | 18,901 | ||||
Accrued compensation | 12,793 | 8,583 | ||||
Accrued liabilities | 14,191 | 14,787 | ||||
Current portion of deferred revenue | 2,165 | 25,354 | ||||
Other current liabilities | 2,633 | 968 | ||||
Long-term portion of lease liabilities | 14,248 | 4,442 | ||||
Long-term portion of deferred revenue | - | 3,434 | ||||
Stockholders' equity | 543,004 | 276,724 | ||||
Total liabilities and stockholders’ equity | 599,250 | 365,261 | ||||
Media and Investor Contact:
Vice President of Corporate Communications and Investor Relations
617.207.8509
kgallagher@akceatx.com