The Company ended the third quarter with over $1B in cash.
- CONTINUED IMPROVEMENT IN OPERATING RESULTS WITH YEAR TO DATE 2017 OPERATING INCOME OF $26 MILLION AND PRO FORMA OPERATING INCOME OF $90 MILLION
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[07-November-2017] |
CARLSBAD, Calif., Nov. 7, 2017 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) today reported GAAP operating income of $13.9 million and $26.2 million for the three and nine months ended September 30, 2017, respectively, compared to GAAP operating income of $16.1 million and a GAAP operating loss of $87.5 million for the same periods in 2016. Ionis also reported pro forma operating income of $35.4 million and $89.9 million for the three and nine months ended September 30, 2017, respectively, compared to pro forma operating income of $33.7 million and a pro forma operating loss of $30.5 million for the same periods in 2016. This quarter is Ionis’ fifth consecutive quarter of pro forma operating income. The Company ended the third quarter with over $1 billion in cash. Ionis is on track to meet its 2017 guidance. “With sales of over $520 million so far this year, SPINRAZA is on track to be one of the most successful rare disease drug launches in history. Demand for SPINRAZA remains strong in the U.S., with Biogen reporting a 75% increase in the number of patients on therapy in the third quarter compared to the second quarter. Notably, last month Biogen reported it had received hundreds of start forms for patients who were not yet on therapy, further demonstrating strong demand for SPINRAZA. SPINRAZA sales outside the U.S. were $73 million in the third quarter, surpassing the initial launch in the U.S., in part due to the broad expanded access program Biogen is conducting globally, including in the EU. Biogen is now selling SPINRAZA in 11 European countries plus Japan, and on a named patient basis in the Middle East and Latin America,” said B. Lynne Parshall, chief operating officer of Ionis Pharmaceuticals. “SPINRAZA also continues to gain recognition in prestigious publications such as The New England Journal of Medicine and The Lancet. Importantly, SPINRAZA was recently awarded the esteemed Prix Galien USA Award for the Best Biotechnology Product in 2017, which recognizes extraordinary achievement in scientific innovation that improves the state of human health.” “Inotersen is now under regulatory review in the U.S. and EU for the treatment of hereditary TTR amyloidosis (hATTR). The European Medicines Agency recently granted accelerated assessment to inotersen, which may reduce the standard review time. We are pleased to have met the last 2017 filing deadline for an EU accelerated assessment filing. In the Phase 3 NEURO-TTR study, inotersen-treated patients experienced significant benefit in their quality of life and in measures of neurological disease compared to placebo-treated patients, and 50% of inotersen-treated patients improved in their quality of life from baseline. We believe that the benefit seen with inotersen in the NEURO-TTR study, combined with its superior convenience, could make inotersen the treatment of choice for this patient population. We are making substantial progress in advancing inotersen to the market, and we are in advanced discussions with potential co-commercialization partners. Inotersen has the potential to contribute significantly to our commercial revenue beginning next year.” “Volanesorsen is now under review for marketing authorization in the U.S., EU, and Canada for the treatment of patients with familial chylomicronemia syndrome. Volanesorsen will be reviewed in the U.S. and EU under a standard review and we were pleased that Akcea received priority review in Canada. Akcea is well along in creating a global commercial organization to support a potential launch of volanesorsen next year. We believe volanesorsen also has the potential to contribute significantly to our commercial revenue beginning next year.” “We have also continued to advance our large, diverse pipeline of over 40 drugs. With continued growth in SPINRAZA sales, and inotersen and volanesorsen moving towards the market, we believe we are well on our way to becoming a multi-product, profitable, commercial company, delivering innovative medicines to patients in need,” concluded Ms. Parshall. Q1:17* Q2:17* Q3:17* ----- ----- ----- $47M $203M $271M SPINRAZA Sales -------------- U.S. U.S., EU, Canada, Japan U.S., EU, Canada, Japan, Brazil, Switzerland Current Approvals ----------------- 88 145 180 U.S. Administration Sites ------------------- 203 233 250 U.S. Site Start Submission Forms ----------------- U.S. Insurance Coverage 100 commercial plans 65 Medicaid plans 80% of commercially insured patients 65% of 85% of commercially insured patients 80% of Medicaid patients Most cover all SMA types Medicaid patients Most cover all SMA types ----------------------- --------------------------------------- --------------------------------------------- --------------------------------------------- 353 in total of which 306 in EU 600 in total of which 460 in EU 680 in total across 26 countries Patients in EAP --------------- EU, Canada, Japan Australia, Brazil, Switzerland, Israel, South Korea Australia, Israel, South Korea, Argentina Current Filings --------------- *As announced by Biogen in their earnings call for the relevant quarter Financial Results “We continued our strong financial performance in the third quarter of 2017. We reported pro forma operating income of $90 million and pro forma net income of $51 million for the first nine months of this year demonstrating our progress toward sustained profitability. Our results were driven by the more than $335 million of revenue we earned in the first nine months of this year, including more than $60 million of commercial revenue from SPINRAZA sales and $270 million of R&D revenue. As expected, our operating expenses increased for the first nine months of 2017 compared to 2016 primarily due to higher commercialization expenses as we and Akcea prepare to launch inotersen and volanesorsen. Fees we owe under our SPINRAZA in-licensing agreements also contributed to the year over year increase. We received over $625 million in cash during the first nine months of 2017, including payments from partners and the proceeds from Akcea’s IPO. We ended the quarter with a cash balance of more than $1 billion,” said Elizabeth L. Hougen, chief financial officer of Ionis Pharmaceuticals. “As we prepare for the launch of inotersen and Akcea prepares for the launch of volanesorsen, we are projecting an increase in our operating expenses for the fourth quarter of 2017 compared to the third quarter of 2017. Even with this increase in operating expenses, we remain on track to meet our financial guidance for 2017 of pro forma operating income in the mid $50 million range and more than $950 million in cash,” concluded Ms. Hougen. 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. Revenue
Commercial Revenue:
R&D Revenue:
Operating Expenses Net Income (Loss)
Net Loss Attributable to Noncontrolling Interest in Akcea Therapeutics, Inc. Net Income (Loss) Attributable to Ionis Pharmaceuticals, Inc. Common Stockholders Balance Sheet Refer to the condensed consolidating statement of operations and balance sheet contained in the financial tables of this earnings release for further information on Ionis’ noncontrolling interest in Akcea. Conference Call At 11:30 a.m. Eastern Time today, November 7, 2017, Ionis will conduct a live webcast conference call to discuss this earnings release and related activities. Interested parties may listen to the call by dialing 877-443-5662 or access the webcast at www.ionispharma.com. A webcast replay will be available for a limited time at the same address. ABOUT IONIS PHARMACEUTICALS, INC. IONIS’ FORWARD-LOOKING STATEMENT 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 trademark of Ionis Pharmaceuticals, Inc. SPINRAZA® is a registered trademark of Biogen. Ionis Pharmaceuticals’ Corporate and Drug Development Highlights Recent SPINRAZA Accomplishments:
Recent Corporate and Pipeline Accomplishments:
Recent Akcea Accomplishments:
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, 2017 2016 2017 2016 ---- ---- Revenue: (unaudited) (unaudited) Commercial revenue: SPINRAZA royalties $32,890 $ - $60,467 $ - Licensing and royalty revenue 879 2,014 4,983 19,689 --- ----- ----- ------ Total commercial revenue 33,769 2,014 65,450 19,689 Research and development revenue under collaborative agreements 87,142 108,913 269,917 166,583 ------ ------- ------- ------- Total revenue 120,911 110,927 335,367 186,272 ------- ------- ------- ------- Expenses: Research, development and patent expenses 80,214 84,631 246,358 243,169 Selling, general and administrative 26,788 10,188 62,782 30,574 ------ ------ ------ ------ Total operating expenses 107,002 94,819 309,140 273,743 ------- ------ ------- ------- Income (loss) from operations 13,909 16,108 26,227 (87,471) Other income (expense): Investment income 2,811 989 7,504 3,912 Interest expense (10,825) (9,746) (33,966) (28,861) Loss on extinguishment of financing liability for leased facility (7,689) - (7,689) - Other expenses (2,141) - (3,528) - --- Income (loss) before income tax expense (3,935) 7,351 (11,452) (112,420) Income tax expense (961) - (1,184) (1) ---- --- ------ --- Net income (loss) (4,896) 7,351 (12,636) (112,421) ====== ===== ======= ======== Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. 3,920 - 3,920 - ===== === ===== === Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders $(976) $7,351 $(8,716) $(112,421) ===== ====== ======= ========= Basic net income (loss) per share $(0.00) $0.06 $0.02 $(0.93) ====== ===== ===== ====== Diluted net income (loss) per share $(0.00) $0.06 $0.02 $(0.93) ====== ===== ===== ====== Shares used in computing basic net income (loss) per share 124,370 120,989 123,746 120,795 ======= ======= ======= ======= Shares used in computing diluted net income (loss) per share 124,370 123,378 123,746 120,795 ======= ======= ======= =======
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, Nine months ended, September 30, September 30, 2017 2016 2017 2016 ---- ---- ---- ---- (unaudited) (unaudited) As reported operating expenses according to GAAP $107,002 $94,819 $309,140 $273,743 Excluding compensation expense related to equity awards (21,472) (17,586) (63,642) (56,950) Pro forma operating expenses $85,530 $77,233 $245,498 $216,793 ======= ======= ======== ======== As reported income (loss) from operations according to GAAP $13,909 $16,108 $26,227 $(87,471) Excluding compensation expense related to equity awards (21,472) (17,586) (63,642) (56,950) Pro forma income (loss) from operations $35,381 $33,694 $89,869 $(30,521) ======= ======= ======= ======== As reported net income (loss) according to GAAP $(4,896) $7,351 $(12,636) $(112,421) Excluding compensation expense related to equity awards (21,472) (17,586) (63,642) (56,950) Pro forma net income (loss) $16,576 $24,937 $51,006 $(55,471) ======= ======= ======= ======== 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) September 30, December 31, 2017 2016 ---- ---- (unaudited) Assets: Cash, cash equivalents and short-term investments $1,010,808 $665,223 Contracts receivable 42,924 108,043 Other current assets 57,381 22,252 Property, plant and equipment, net 116,624 92,845 Other assets 24,824 24,104 ------ ------ Total assets $1,252,561 $912,467 ========== ======== Liabilities and stockholders’ equity: Other current liabilities $72,734 $82,504 Current portion of deferred contract revenue 104,913 51,280 1% convertible senior notes 524,744 500,511 Long-term obligations, less current portion 72,846 87,409 Long-term deferred contract revenue 79,656 91,198 Total Ionis stockholders’ equity 307,968 99,565 Noncontrolling interest in Akcea Therapeutics, Inc. 89,700 - ------ --- Total stockholders’ equity 397,668 99,565 ------- ------ Total liabilities and stockholders’ equity $1,252,561 $912,467 ========== ========
IONIS PHARMACEUTICALS, INC. SELECTED FINANCIAL INFORMATION Condensed Consolidating Statement of Operations (In Thousands) Nine months ended, September 30, 2017 (unaudited) ---------- Ionis Akcea Eliminations Ionis Consolidated ------------ Revenue: Commercial revenue: SPINRAZA royalties $60,467 $ - $ - $60,467 Licensing and royalty revenue 4,983 - - 4,983 ----- --- --- ----- Total commercial revenue 65,450 - - 65,450 Research and development revenue under collaborative agreements 232,744 $37,173 - 269,917 Intercompany revenue 54,407 - (54,407) - ------ --- ------- --- Total revenue 352,601 37,173 (54,407) 335,367 ------- ------ ------- ------- Expenses: Research, development and patent expenses 199,934 100,921 (54,497) 246,358 Selling, general and administrative 42,819 19,963 - 62,782 ------ ------ --- ------ Total operating expenses 242,753 120,884 (54,497) 309,140 ------- ------- ------- ------- Income (loss) from operations 109,848 (83,711) 90 26,227 Other income (expense): Investment income 8,241 994 (1,731) 7,504 Interest expense (33,966) (1,731) 1,731 (33,966) Loss on extinguishment of financing liability for leased facility (7,689) - - (7,689) Other expenses (3,652) 124 - (3,528) --- Income (loss) before income tax expense 72,782 (84,324) 90 (11,452) Income tax benefit (expense) 882 (2,066) - (1,184) --- ------ --- ------ Net income (loss) 73,664 (86,390) 90 (12,636) ====== ======= === ======= Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. - - 3,920 3,920 === === ===== ===== Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders $73,664 $(86,390) $4,010 $(8,716) ======= ======== ====== =======
IONIS PHARMACEUTICALS, INC. Condensed Consolidating Balance Sheet (In Thousands) September 30, 2017 (unaudited) ---------- Ionis Akcea Eliminations Ionis Consolidated ------------ Assets: Cash, cash equivalents and short-term investments $724,677 $286,131 $ - $1,010,808 Contracts receivable 42,424 500 - 42,924 Receivable from Akcea Therapeutics, Inc. 9,501 - (9,501) - Other current assets 56,132 1,249 - 57,381 Property, plant and equipment, net 116,520 104 - 116,624 Other assets 297,733 1,365 (274,274) 24,824 ------- ----- -------- ------ Total assets $1,246,987 $289,349 $(283,775) $1,252,561 ========== ======== ========= ========== Liabilities and stockholders’ equity: Other current liabilities $62,822 $19,413 $(9,501) $72,734 Current portion of deferred contract revenue 50,870 54,043 - 104,913 1% convertible senior notes 524,744 - - 524,744 Long-term obligations, less current portion 72,832 14 - 72,846 Long-term deferred contract revenue 63,319 18,035 (1,698) 79,656 Total stockholders’ equity before noncontrolling interest 472,400 197,844 (362,276) 307,968 Noncontrolling interest in Akcea Therapeutics, Inc. - - 89,700 89,700 --- ------ ------ Total stockholders’ equity 472,400 197,844 (272,576) 397,668 ======= ======= ======== ======= Total liabilities and stockholders’ equity $1,246,987 $289,349 $(283,775) $1,252,561 ========== ======== ========= ==========
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Company Codes: NASDAQ-NMS:IONS |