000-19125
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33-0336973
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(Commission File No.)
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(IRS Employer Identification No.)
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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99.1 | Press Release dated August 4, 2014. |
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Isis Pharmaceuticals, Inc.
|
|
Dated: August 4, 2014
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By:
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/s/ B. Lynne Parshall |
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B. Lynne Parshall
|
|
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Chief Operating Officer
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99.1 | Press Release dated August 4, 2014. |
· | $40 million in milestone payments from partners drives improved quarterly financial performance |
· | Conference Call Webcast Monday, August 4, 10:30 a.m. ET at www.isispharm.com |
· | Initiate an additional Phase 3 clinical study on ISIS-SMNRx. |
· | Initiate a Phase 3 clinical program on ISIS-APOCIIIRx. |
· | Report the full data analysis of the Phase 2 study of ISIS-FXIRx at an upcoming medical meeting. |
· | Report data from Phase 2 studies of ISIS-SMNRx in both children and infants with SMA at an upcoming medical meeting. |
· | Report Phase 2 data from ISIS-GCCRRx and ISIS-PTP1BRx in patients with type 2 diabetes. |
· | $24.5 million from Biogen Idec related to advancing ISIS-SMNRx, initiating a Phase 1 study for ISIS-DMPKRx, and validating an undisclosed target to treat a neurological disorder; |
· | $15 million from AstraZeneca related to initiating a Phase 1 clinical study of ISIS-ARRx; and |
· | $2 million from GSK related to advancing ISIS-TTRRx. |
·
|
Isis reported positive clinical results from five drugs in later-stage development. These data exemplify the broad applicability and potential for antisense drugs to provide therapeutic benefit to many different diseases.
|
o
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Isis reported positive Phase 2 data on ISIS-APOCIIIRx in patients with high to extremely high triglyceride levels as a single agent and in combination with fibrates. In these studies, patients experienced substantial reductions of triglyceride and apoC-III levels with significant increases in HDL-cholesterol. These Phase 2 data were presented at the Arteriosclerosis, Thrombosis and Vascular Biology and the National Lipid Association meetings.
|
o
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Isis presented positive results from both of the ongoing multiple-dose open label Phase 2 studies of ISIS-SMNRx in infants and children with SMA, which were consistent with earlier reported data. In these studies, Isis reported increases in muscle function scores in infants and children treated with ISIS-SMNRx. These Phase 2 data were presented at the American Academy of Neurology meeting.
|
o
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Isis reported positive Phase 2 data for ISIS-GCGRRx in patients with type 2 diabetes. In this study, patients with type 2 diabetes uncontrolled on stable metformin therapy experienced up to a 2.25 percentage point mean reduction in HbA1c levels after 13 weeks of dosing. These Phase 2 data were presented at the American Diabetes Association Scientific Sessions.
|
o
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Isis reported positive top-line Phase 2 clinical results for ISIS-FXIRx in patients undergoing total knee replacement. In this study, ISIS-FXIRx-treated patients experienced a dose-dependent decrease in venous thromboembolism and numerically fewer bleeding events compared to patients treated with enoxaparin.
|
o
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Isis reported Phase 2 results showing that ISIS-CRPRx produced statistically significant mean reductions of CRP protein of 65% with reductions as great as 84% in patients with atrial fibrillation (AF). In addition, two patients who had elevated levels of CRP (>5 mg/L) experienced a reduction of CRP that was associated with a decline to zero in overall AF burden while on treatment.
|
·
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Isis continued to advance its pipeline of drugs.
|
o
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Isis initiated a Phase 3 study, ENDEAR, of ISIS-SMNRx in infants with SMA and will earn an $18 million milestone payment upon dosing of the first infant. This is the first of several planned studies in a broad and comprehensive late-stage clinical development program for ISIS-SMNRx.
|
o
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Isis initiated a Phase 2 study of ISIS-APO(a)Rx in patients with high levels of lipoprotein(a), an independent risk factor for cardiovascular disease.
|
o
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Isis initiated a Phase 1 study of ISIS-PKKRx, an antisense drug to treat patients with hereditary angioedemia, and a Phase 1 study of ISIS-DMPKRx, an antisense drug to treat patients with myotonic dystrophy type 1.
|
o
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AstraZeneca initiated a Phase 1 study of ISIS-ARRx, an antisense drug discovered by Isis to treat patients with cancer.
|
o
|
Isis added a new drug, ISIS-HTTRx, to its pipeline. ISIS-HTTRx is part of Isis’ alliance with Roche and is in development to treat patients with Huntington’s Disease.
|
·
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Isis and its partners were recognized by the drug development community for Isis’ innovative and collaborative alliances and Isis’ commitment to developing drugs to treat patients with serious, unmet medical needs.
|
o
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Isis and Genzyme received the 2014 Partners in Progress Corporate Award from the National Organization for Rare Disorders (NORD) for the development and approval of KYNAMRO, a drug selected for being a very important orphan therapy to reach the market in the United States. This award honors companies that have brought important and innovative treatments to market for patients with rare disorders.
|
o
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Isis’ and Biogen Idec’s innovative collaboration was voted breakthrough alliance of 2014 by Thomson Reuters Recap.
|
o
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Frank Bennett, Ph.D., Isis’ senior vice president, research, was a recipient of the Commitment to a Cure Award by the ALS Association for his and Isis’ research and commitment to develop a treatment for amyotrophic lateral sclerosis (ALS).
|
D. Wade Walke, Ph.D.
Vice President, Corporate Communications and Investor Relations
760-603-2741
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Amy Blackley, Ph.D.
Associate Director, Corporate Communications
760-603-2772
|
|
Three months ended,
|
Six months ended,
|
||||||||||||||
|
June 30,
|
June 30,
|
||||||||||||||
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
Revenue:
|
(unaudited)
|
(unaudited)
|
||||||||||||||
Research and development revenue under collaborative agreements
|
$
|
56,628
|
$
|
37,615
|
$
|
76,177
|
$
|
79,285
|
||||||||
Licensing and royalty revenue
|
448
|
477
|
9,060
|
2,166
|
||||||||||||
Total revenue
|
57,076
|
38,092
|
85,237
|
81,451
|
||||||||||||
Expenses:
|
||||||||||||||||
Research, development and patent expenses
|
59,264
|
42,631
|
112,712
|
80,944
|
||||||||||||
General and administrative
|
4,462
|
3,389
|
8,842
|
6,811
|
||||||||||||
Total operating expenses
|
63,726
|
46,020
|
121,554
|
87,755
|
||||||||||||
Loss from operations
|
(6,650
|
)
|
(7,928
|
)
|
(36,317
|
)
|
(6,304
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Investment income
|
671
|
589
|
1,328
|
967
|
||||||||||||
Interest expense
|
(4,961
|
)
|
(4,808
|
)
|
(9,904
|
)
|
(9,603
|
)
|
||||||||
Gain (loss) on investments, net
|
(260
|
)
|
840
|
137
|
1,898
|
|||||||||||
Loss before income tax benefit
|
(11,200
|
)
|
(11,307
|
)
|
(44,756
|
)
|
(13,042
|
)
|
||||||||
|
||||||||||||||||
Income tax benefit (expense)
|
(881
|
)
|
1,181
|
1,395
|
1,244
|
|||||||||||
|
||||||||||||||||
Net loss
|
$
|
(12,081
|
)
|
$
|
(10,126
|
)
|
$
|
(43,361
|
)
|
$
|
(11,798
|
)
|
||||
|
||||||||||||||||
Basic and diluted net loss per share
|
$
|
(0.10
|
)
|
$
|
(0.09
|
)
|
$
|
(0.37
|
)
|
$
|
(0.11
|
)
|
||||
Shares used in computing basic and diluted net loss per share
|
117,588
|
108,539
|
117,359
|
105,225
|
|
Three months ended,
June 30,
|
Six months ended,
June 30,
|
||||||||||||||
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
(unaudited)
|
(unaudited)
|
||||||||||||||
|
||||||||||||||||
As reported operating expenses according to GAAP
|
$
|
63,726
|
$
|
46,020
|
$
|
121,554
|
$
|
87,755
|
||||||||
Excluding compensation expense related to equity awards
|
(7,708
|
)
|
(2,636
|
)
|
(14,777
|
)
|
(5,505
|
)
|
||||||||
|
||||||||||||||||
Pro forma operating expenses
|
$
|
56,018
|
$
|
43,384
|
$
|
106,777
|
$
|
82,250
|
||||||||
|
||||||||||||||||
As reported loss from operations according to GAAP
|
$
|
(6,650
|
)
|
$
|
(7,928
|
)
|
$
|
(36,317
|
)
|
$
|
(6,304
|
)
|
||||
Excluding compensation expense related to equity awards
|
(7,708
|
)
|
(2,636
|
)
|
(14,777
|
)
|
(5,505
|
)
|
||||||||
|
||||||||||||||||
Pro forma income (loss) from operations
|
$
|
1,058
|
$
|
(5,292
|
)
|
$
|
(21,540
|
)
|
$
|
(799
|
)
|
|||||
As reported net loss according to GAAP
|
$
|
(12,081
|
)
|
$
|
(10,126
|
)
|
$
|
(43,361
|
)
|
$
|
(11,798
|
)
|
||||
Excluding compensation expense related to equity awards
|
(7,708
|
)
|
(2,636
|
)
|
(14,777
|
)
|
(5,505
|
)
|
||||||||
|
||||||||||||||||
Pro forma net loss
|
$
|
(4,373
|
)
|
$
|
(7,490
|
)
|
$
|
(28,584
|
)
|
$
|
(6,293
|
)
|
|
June 30,
|
December 31,
|
||||||
|
2014
|
2013
|
||||||
|
(unaudited)
|
|||||||
Assets:
|
||||||||
$
|
590,835
|
$
|
656,761
|
|||||
Investment in Regulus Therapeutics Inc.
|
56,678
|
52,096
|
||||||
Other current assets
|
58,284
|
26,653
|
||||||
Property, plant and equipment, net
|
86,321
|
86,198
|
||||||
Other assets
|
25,659
|
25,448
|
||||||
Total assets
|
$
|
817,777
|
$
|
847,156
|
||||
|
||||||||
Liabilities and stockholders’ equity:
|
||||||||
Other current liabilities
|
$
|
49,256
|
$
|
49,677
|
||||
Current portion of deferred contract revenue
|
51,560
|
48,135
|
||||||
2 3/4% convertible senior notes
|
153,700
|
150,334
|
||||||
Long-term obligations, less current portion
|
76,014
|
77,830
|
||||||
Long-term deferred contract revenue
|
120,387
|
142,790
|
||||||
Stockholders’ equity
|
366,860
|
378,390
|
||||||
Total liabilities and stockholders’ equity
|
$
|
817,777
|
$
|
847,156
|