Delaware
|
94-3023969
|
(State or Other Jurisdiction of Incorporation)
|
(I.R.S. Employer Identification No.)
|
¨
|
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))
|
Exhibit No.
|
Description
|
|
99.1
|
Press Release
|
|
99.2
|
Information Sheet
|
PDL BIOPHARMA, INC.
|
||
(Company)
|
||
By:
|
/s/ Christine R. Larson
|
|
Christine R. Larson
|
||
Vice President and Chief Financial Officer
|
Cris Larson
|
Jennifer Williams
|
PDL BioPharma, Inc.
|
Cook Williams Communications
|
775-832-8505
|
360-668-3701
|
Cris.Larson@pdl.com
|
jennifer@cwcomm.org
|
|
·
|
The expected rate of growth in royalty-bearing product sales by PDL’s existing licensees;
|
|
·
|
The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus manufactured or sold in the U.S.;
|
|
·
|
The ability of our licensees to receive regulatory approvals to market and launch new royalty-bearing products and whether such products, if launched, will be commercially successful;
|
|
·
|
Changes in any of the other assumptions on which PDL’s projected royalty revenues are based;
|
|
·
|
The outcome of pending litigation or disputes;
|
|
·
|
The change in foreign currency exchange rates; and
|
|
·
|
The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
|
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Revenues:
|
||||||||||||||||
Royalties
|
$ | 122,127 | $ | 120,343 | $ | 195,463 | $ | 182,404 | ||||||||
License and other
|
- | - | 10,000 | - | ||||||||||||
Total revenues
|
122,127 | 120,343 | 205,463 | 182,404 | ||||||||||||
General and administrative expenses
|
3,776 | 8,820 | 9,555 | 18,230 | ||||||||||||
Operating income
|
118,351 | 111,523 | 195,908 | 164,174 | ||||||||||||
Loss on repurchase of convertible notes
|
(766 | ) | (16,327 | ) | (766 | ) | (16,327 | ) | ||||||||
Interest and other income
|
157 | 90 | 332 | 170 | ||||||||||||
Interest and other expense
|
(9,780 | ) | (11,560 | ) | (18,934 | ) | (24,087 | ) | ||||||||
Total non-operating expense, net
|
(10,389 | ) | (27,797 | ) | (19,368 | ) | (40,244 | ) | ||||||||
Income before income taxes
|
107,962 | 83,726 | 176,540 | 123,930 | ||||||||||||
Income tax expense
|
37,976 | 33,588 | 62,009 | 47,785 | ||||||||||||
Net income
|
$ | 69,986 | $ | 50,138 | $ | 114,531 | $ | 76,145 | ||||||||
Net income per basic share
|
$ | 0.50 | $ | 0.42 | $ | 0.82 | $ | 0.64 | ||||||||
Net income per diluted share
|
$ | 0.38 | $ | 0.30 | $ | 0.63 | $ | 0.44 | ||||||||
Cash dividends declared per common share
|
$ | - | $ | - | $ | 0.60 | $ | 1.00 | ||||||||
Shares used to compute net income per basic and diluted share:
|
||||||||||||||||
Shares used to compute income per basic share
|
139,650 | 119,536 | 139,645 | 119,530 | ||||||||||||
Shares used to compute income per diluted share
|
186,060 | 173,398 | 186,055 | 178,821 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Net income
|
$ | 69,986 | $ | 50,138 | $ | 114,531 | $ | 76,145 | ||||||||
Add Back:
|
||||||||||||||||
Loss on repurchase of convertible notes, net of estimated taxes
|
498 | 14,737 | 498 | 14,737 | ||||||||||||
Amortization of debt discount for May 2015 Notes, net of estimated taxes
|
337 | - | 337 | - | ||||||||||||
Non-GAAP net income
|
70,821 | 64,875 | 115,366 | 90,882 | ||||||||||||
Add back interest expense for shares associated with convertible notes included in determination of fully diluted shares, net of estimated taxes
|
1,275 | 1,360 | 2,594 | 2,995 | ||||||||||||
Non-GAAP income used to compute non-GAAP net income per diluted share
|
$ | 72,096 | $ | 66,235 | $ | 117,960 | $ | 93,877 | ||||||||
Non-GAAP net income per diluted share
|
$ | 0.39 | $ | 0.38 | $ | 0.63 | $ | 0.52 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Compensation and benefits
|
$ | 970 | $ | 996 | $ | 1,912 | $ | 1,997 | ||||||||
Legal expense
|
1,404 | 5,811 | 4,898 | 12,161 | ||||||||||||
Other professional service
|
623 | 1,005 | 1,191 | 2,083 | ||||||||||||
Insurance
|
176 | 195 | 380 | 423 | ||||||||||||
Depreciation
|
14 | 28 | 29 | 62 | ||||||||||||
Stock-based compensation
|
74 | 171 | 124 | 359 | ||||||||||||
Other
|
515 | 614 | 1,021 | 1,145 | ||||||||||||
Total general and administrative expenses
|
$ | 3,776 | $ | 8,820 | $ | 9,555 | $ | 18,230 |
|
June 30,
|
December 31,
|
||||||
2011
|
2010
|
|||||||
Cash, cash equivalents and investments
|
$ | 236,321 | $ | 248,229 | ||||
Total assets
|
$ | 284,261 | $ | 316,666 | ||||
Convertible notes payable
|
$ | 314,142 | $ | 310,428 | ||||
Non-recourse notes payable
|
$ | 141,700 | $ | 204,270 | ||||
Total stockholders' deficit
|
$ | (293,508 | ) | $ | (324,182 | ) |
Six Months Ended
|
||||||||
June 30,
|
||||||||
2011
|
2010
|
|||||||
Net income
|
$ | 114,531 | $ | 76,145 | ||||
Adjustments to reconcile net income to net cash provided by operating activities
|
24,941 | 17,889 | ||||||
Changes in assets and liabilities
|
(51,549 | ) | 29,593 | |||||
Net cash provided by operating activities
|
$ | 87,923 | $ | 123,627 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Avastin
|
||||||||||||||||
% Ex-U.S. Sold
|
55 | % | 49 | % | 55 | % | 49 | % | ||||||||
% Ex-U.S.-based Manufactured and Sold
|
20 | % | 27 | % | 20 | % | 16 | % | ||||||||
Herceptin
|
||||||||||||||||
% Ex-U.S. Sold
|
72 | % | 70 | % | 71 | % | 70 | % | ||||||||
% Ex-U.S.-based Manufactured and Sold
|
30 | % | 47 | % | 35 | % | 45 | % | ||||||||
Lucentis
|
||||||||||||||||
% Ex-U.S. Sold
|
57 | % | 57 | % | 57 | % | 57 | % | ||||||||
% Ex-U.S.-based Manufactured and Sold
|
- | - | - | - | ||||||||||||
Xolair
|
||||||||||||||||
% Ex-U.S. Sold
|
40 | % | 36 | % | 39 | % | 35 | % | ||||||||
% Ex-U.S.-based Manufactured and Sold
|
40 | % | 36 | % | 39 | % | 35 | % |
|
·
|
On May 26, 2011, Roche announced positive data using ACTEMRA/RoACTEMRA to treat patients with rheumatoid arthritis. The data showed that monotherapy with Actemra had comparable clinical efficacy to treatment with Actemra plus methotrexate.
|
|
·
|
On July 19, 2011, Chugai announced that a subcutaneous injection of Actemra has shown efficacy in rheumatoid arthritis compared to intravenous infusion. Based on these non-inferiority data, the company plans to file for approval in Japan in 2012.
|
|
·
|
On June 4, 2011, Roche reported positive results from a Phase 3 clinical trial in women with recurrent platinum-sensitive ovarian cancer treated with Avastin in combination with chemotherapy (gemcitabine and carboplatin), followed by continued use of Avastin alone. Women who received Avastin experienced a 52 percent reduction in the risk of their disease progressing, compared to women who received chemotherapy alone.
|
|
·
|
On June 30, 2011, Roche announced that a special appeals panel of advisors to the U.S. Food and Drug Administration (FDA) recommended that the FDA withdraw its approval of Avastin in combination with paclitaxel chemotherapy for first-line HER2-negative metastatic breast cancer. Avastin plus paclitaxel is still FDA-approved for women with HER2-negative metastatic breast cancer. The FDA commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The appeals panel’s recommendation has no impact on Avastin’s approved uses for other cancers or the use of Avastin for metastatic breast cancer in other countries.
|
|
·
|
On June 30, 2011, the European Commission extended the existing Avastin metastatic breast cancer label to include Avastin in combination with Xeloda® (capecitabine) in first-line therapy.
|
|
·
|
Also on June 30, 2011, Medicare announced that it would continue to cover use of Avastin for patients with breast cancer.
|
|
·
|
On July 20, 2011, the expert breast cancer panel of the National Comprehensive Cancer Network recommended the use of Avastin plus paclitaxel as a therapeutic option for metastatic breast cancer.
|
|
·
|
On April 28, 2011, The New England Journal of Medicine reported results from the National Eye Institute’s CATT study comparing Lucentis and Avastin of fixed and variable schedules in the treatment of AMD. Efficacy results from the first year of the two year study showed that, with respect to primary endpoint of mean change in visual acuity (number of lines of letters on an eye chart) at 12 months, less expensive Avastin was not inferior to Lucentis.
|
|
·
|
On May 4, 2011, Genentech and Novartis reported a new analysis conducted by Johns Hopkins University showing that the risk of death and stroke is higher for patients treated with intravitreal Avastin when compared to Lucentis.
|
|
·
|
On June 6, 2011, Novartis announced that Lucentis had been approved in Europe for the treatment of visual impairment due to macular edema secondary to retinal occlusion.
|
|
·
|
On June 28, 2011, Genentech reported positive results from two pivotal Phase 3 clinical studies in patients with diabetic macular edema. Both studies showed that patients treated with Lucentis experienced significant, rapid and sustained improvement in vision compared to those who received sham injections. Additional analyses showed that patients who received Lucentis were significantly more likely to achieve 20/40 vision and experience less progression of underlying diabetic retinopathy disease.
|
|
·
|
On May 26, 2011, Johnson & Johnson stated that it will seek U.S. regulatory approval of bapineuzumab in 2012 or 2013. This drug was linked to a transient side effect similar to swelling of the brain when given at high doses in study results released last year.
|
|
·
|
On July 12, 2011, academic and industry experts convinced U.S. regulators to ease safety restrictions imposed on clinical trials of Alzheimer’s drugs, including bapineuzumab.
|
|
·
|
On July 19, 2011, researchers from Pfizer and Johnson & Johnson reported long-term safety of 194 patients in a mid-stage trial of the drug that stayed on treatment after the initial phase ended. The brain swelling condition called vasogenic edema, which caused safety concerns early on in the trial, may decrease over time.
|
|
·
|
The expected rate of growth in royalty-bearing product sales by PDL's existing licensees;
|
|
·
|
The relative mix of royalty-bearing Genentech products manufactured and sold outside the U.S. versus manufactured or sold in the U.S.;
|
|
·
|
The ability of our licensees to receive regulatory approvals to market and launch new royalty-bearing products and whether such products, if launched, will be commercially successful;
|
|
·
|
Changes in any of the other assumptions on which PDL's projected royalty revenues are based;
|
|
·
|
The outcome of pending litigation or disputes;
|
|
·
|
The change in foreign currency exchange rates; and
|
|
·
|
The failure of licensees to comply with existing license agreements, including any failure to pay royalties due.
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
22,283
|
41,967
|
-
|
-
|
64,250
|
2010
|
16,870
|
44,765
|
29,989
|
24,922
|
116,547
|
2009
|
13,605
|
35,161
|
21,060
|
15,141
|
84,966
|
2008
|
9,957
|
30,480
|
19,574
|
12,394
|
72,405
|
2007
|
8,990
|
21,842
|
17,478
|
9,549
|
57,859
|
2006
|
10,438
|
15,572
|
15,405
|
12,536
|
53,952
|
Herceptin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
25,089
|
42,209
|
-
|
-
|
67,298
|
2010
|
23,402
|
38,555
|
27,952
|
25,441
|
115,350
|
2009
|
16,003
|
32,331
|
26,830
|
18,615
|
93,779
|
2008
|
14,092
|
34,383
|
28,122
|
20,282
|
96,880
|
2007
|
19,035
|
28,188
|
22,582
|
14,802
|
84,608
|
2006
|
15,142
|
19,716
|
21,557
|
20,354
|
76,769
|
Lucentis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
8,878
|
24,313
|
-
|
-
|
33,191
|
2010
|
7,220
|
19,091
|
10,841
|
8,047
|
45,198
|
2009
|
4,621
|
12,863
|
8,123
|
6,152
|
31,759
|
2008
|
3,636
|
11,060
|
7,631
|
4,549
|
26,876
|
2007
|
2,931
|
6,543
|
6,579
|
3,517
|
19,570
|
2006
|
-
|
-
|
289
|
3,335
|
3,624
|
Xolair
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
4,590
|
7,621
|
-
|
-
|
12,211
|
2010
|
3,723
|
6,386
|
4,980
|
4,652
|
19,741
|
2009
|
2,665
|
5,082
|
4,085
|
3,722
|
15,553
|
2008
|
1,488
|
4,866
|
3,569
|
2,927
|
12,850
|
2007
|
1,684
|
3,942
|
3,332
|
2,184
|
11,142
|
2006
|
2,263
|
2,969
|
3,041
|
2,495
|
10,768
|
Tysabri
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
9,891
|
10,796
|
-
|
-
|
20,687
|
2010
|
8,791
|
8,788
|
8,735
|
9,440
|
35,754
|
2009
|
6,656
|
7,050
|
7,642
|
8,564
|
29,912
|
2008
|
3,883
|
5,042
|
5,949
|
6,992
|
21,866
|
2007
|
839
|
1,611
|
2,084
|
2,836
|
7,370
|
2006
|
-
|
-
|
-
|
237
|
237
|
Avastin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
1,597,461
|
1,582,705
|
-
|
-
|
3,180,166
|
2010
|
1,506,788
|
1,596,892
|
1,594,707
|
1,646,218
|
6,344,605
|
2009
|
1,345,487
|
1,295,536
|
1,439,730
|
1,514,053
|
5,594,806
|
2008
|
980,715
|
1,084,930
|
1,180,427
|
1,239,382
|
4,485,454
|
2007
|
678,068
|
746,587
|
797,013
|
875,084
|
3,096,752
|
2006
|
439,318
|
516,052
|
570,551
|
592,897
|
2,118,817
|
Herceptin
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
1,391,568
|
1,559,975
|
-
|
-
|
2,951,543
|
2010
|
1,270,846
|
1,349,512
|
1,300,934
|
1,409,310
|
5,330,602
|
2009
|
1,210,268
|
1,133,993
|
1,226,435
|
1,278,626
|
4,849,323
|
2008
|
1,105,426
|
1,195,215
|
1,211,982
|
1,186,806
|
4,699,428
|
2007
|
891,761
|
949,556
|
979,602
|
1,015,033
|
3,835,952
|
2006
|
529,585
|
659,719
|
761,099
|
803,576
|
2,753,979
|
Lucentis
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
887,757
|
943,418
|
-
|
-
|
1,831,175
|
2010
|
721,967
|
698,890
|
745,376
|
804,684
|
2,970,917
|
2009
|
462,103
|
469,736
|
555,296
|
615,212
|
2,102,347
|
2008
|
363,615
|
393,682
|
460,167
|
454,922
|
1,672,386
|
2007
|
224,820
|
219,579
|
299,995
|
322,300
|
1,066,695
|
2006
|
-
|
-
|
10,689
|
157,742
|
168,431
|
Xolair
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
267,754
|
277,642
|
-
|
-
|
545,396
|
2010
|
228,859
|
225,878
|
251,055
|
263,389
|
969,179
|
2009
|
184,669
|
181,086
|
211,006
|
219,693
|
796,454
|
2008
|
137,875
|
169,521
|
177,179
|
183,753
|
668,329
|
2007
|
129,172
|
130,700
|
144,250
|
147,754
|
551,876
|
2006
|
95,241
|
99,354
|
112,608
|
118,002
|
425,204
|
Tysabri
|
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
2011
|
329,696
|
356,876
|
-
|
-
|
686,572
|
2010
|
293,047
|
287,925
|
293,664
|
316,657
|
1,191,292
|
2009
|
221,854
|
229,993
|
257,240
|
285,481
|
994,569
|
2008
|
129,430
|
163,076
|
200,783
|
233,070
|
726,359
|
2007
|
30,468
|
48,715
|
71,972
|
94,521
|
245,675
|
2006
|
-
|
-
|
-
|
7,890
|
7,890
|
Avastin Sales
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
US Made & Sold
|
755,680
|
814,872
|
820,453
|
800,139
|
708,539
|
719,967
|
US Made & ex-US Sold
|
668,478
|
355,742
|
338,929
|
415,576
|
580,981
|
548,710
|
ex-US Made & Sold
|
82,630
|
426,277
|
435,325
|
430,503
|
307,941
|
314,028
|
Total
|
1,506,788
|
1,596,892
|
1,594,707
|
1,646,218
|
1,597,461
|
1,582,705
|
US Made & Sold
|
50%
|
51%
|
51%
|
49%
|
44%
|
45%
|
US Made & ex-US Sold
|
44%
|
22%
|
21%
|
25%
|
36%
|
35%
|
ex-US Made & Sold
|
5%
|
27%
|
27%
|
26%
|
19%
|
20%
|
Herceptin Sales
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
US Made & Sold
|
375,139
|
406,222
|
410,563
|
416,611
|
409,854
|
442,903
|
US Made & ex-US Sold
|
353,539
|
312,792
|
306,085
|
425,303
|
423,053
|
642,670
|
ex-US Made & Sold
|
542,168
|
630,498
|
584,286
|
567,396
|
558,661
|
474,402
|
Total
|
1,270,846
|
1,349,512
|
1,300,934
|
1,409,310
|
1,391,568
|
1,559,975
|
US Made & Sold
|
30%
|
30%
|
32%
|
30%
|
29%
|
28%
|
US Made & ex-US Sold
|
28%
|
23%
|
24%
|
30%
|
30%
|
41%
|
ex-US Made & Sold
|
43%
|
47%
|
45%
|
40%
|
40%
|
30%
|
Lucentis Sales
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
US Made & Sold
|
306,995
|
300,501
|
326,840
|
360,911
|
378,451
|
409,674
|
US Made & ex-US Sold
|
414,972
|
398,389
|
418,536
|
443,773
|
509,307
|
533,745
|
ex-US Made & Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
Total
|
721,967
|
698,890
|
745,376
|
804,684
|
887,757
|
943,418
|
US Made & Sold
|
43%
|
43%
|
44%
|
45%
|
43%
|
43%
|
US Made & ex-US Sold
|
57%
|
57%
|
56%
|
55%
|
57%
|
57%
|
ex-US Made & Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
Xolair Sales
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
US Made & Sold
|
149,628
|
145,245
|
165,109
|
170,001
|
164,621
|
167,608
|
US Made & ex-US Sold
|
-
|
-
|
-
|
-
|
-
|
-
|
ex-US Made & Sold
|
79,231
|
80,632
|
85,945
|
93,388
|
103,133
|
110,034
|
Total
|
228,859
|
225,878
|
251,055
|
263,389
|
267,754
|
277,642
|
US Made & Sold
|
65%
|
64%
|
66%
|
65%
|
61%
|
60%
|
US Made & ex-US Sold
|
0%
|
0%
|
0%
|
0%
|
0%
|
0%
|
ex-US Made & Sold
|
35%
|
36%
|
34%
|
35%
|
39%
|
40%
|
Total Sales
|
2010 - Q1
|
2010 - Q2
|
2010 - Q3
|
2010 - Q4
|
2011 - Q1
|
2011 - Q2
|
US Made & Sold
|
1,587,442
|
1,666,840
|
1,722,965
|
1,747,662
|
1,661,465
|
1,740,152
|
US Made & ex-US Sold
|
1,436,989
|
1,081,147
|
1,063,551
|
1,284,652
|
1,513,340
|
1,725,125
|
ex-US Made & Sold
|
704,029
|
1,137,407
|
1,105,556
|
1,091,287
|
969,735
|
898,464
|
Total
|
3,728,460
|
3,885,394
|
3,892,072
|
4,123,601
|
4,144,540
|
4,363,741
|
US Made & Sold
|
43%
|
43%
|
44%
|
42%
|
40%
|
40%
|
US Made & ex-US Sold
|
39%
|
28%
|
27%
|
31%
|
37%
|
40%
|
ex-US Made & Sold
|
19%
|
29%
|
28%
|
26%
|
23%
|
21%
|
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