001-10865 | 04-2742593 | |
(Commission File Number) | (IRS Employer Identification No.) | |
1100 Winter Street | ||
Waltham, Massachusetts | 02451 | |
(Address of principal executive offices) | (Zip Code) |
Exhibit Number | Description | |
99.1 | Press release dated November 3, 2016. | |
99.2 | Copy of Company’s presentation slides dated November 3, 2016. |
AMAG PHARMACEUTICALS, INC. | |||
By: | /s/ Joseph D. Vittiglio, Esq. | ||
Name: Joseph D. Vittiglio, Esq. | |||
Title: Senior Vice President, General Counsel and Secretary | |||
Date: | November 3, 2016 |
Exhibit Number | Description | |
99.1 | Press release dated November 3, 2016. | |
99.2 | Copy of Company’s presentation slides dated November 3, 2016. |
• | Delivered total revenue of $143.8 million in the third quarter of 2016, compared with $96.2 million in the same period last year. This increase of approximately 50% was driven by record sales of Makena and the recognition of a full quarter of revenue from CBR. |
• | Achieved Makena sales of $93.4 million in the third quarter of 2016, compared with $65.2 million in the same period last year. Makena's robust sales growth of 43% was driven exclusively by an increase in volume. This growth resulted in Makena market share of 41%, four percentage points over the second quarter of 2016 and an 11 percentage point gain year-to-date. |
• | Generated 1.8% growth to $29.9 million1 in non-GAAP revenue from CBR over the second quarter of 2016 due to improved net revenue per new customer. In addition, enrollments were higher versus the second quarter of 2016. |
• | Reported $22.3 million in Feraheme sales, maintaining market share in the intravenous iron market, which experienced a slight decline in the third quarter of 2016. |
1 | See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release. |
• | Achieved key milestones in the Makena subcutaneous auto-injector development program. The company dosed first subjects in both the definitive pharmacokinetic study and comparative pain study. Data from each of these studies is intended to support the supplemental new drug application (sNDA) that the company plans to file with the Food and Drug Administration (FDA) in the second quarter of 2017. |
• | Continued to enroll patients more rapidly than expected in the company’s head-to-head, Phase 3 clinical trial evaluating Feraheme in adults with iron deficiency anemia (IDA). The company is seeking to broaden Feraheme’s current label beyond its chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment. The timeline to anticipated approval has been shortened by approximately six months as a result of the trial’s rapid enrollment, which has accelerated the company's expected sNDA submission date to mid-2017. |
• | Generated an increase of $147.7 million in cash and investments in the first nine months of 2016 to $614.1 million, net of $20.0 million utilized to repurchase the company’s common stock and $13.1 million to repay debt. |
2016 GAAP Guidance | 2016 Non-GAAP Guidance | |||||
$ in millions | Previous | Updated | Previous | Updated | ||
Makena sales | $310 - $340 | $330 - $340 | $310 - $340 | $330 - $340 | ||
Feraheme and MuGard sales | $95 - $105 | $95 - $105 | $95 - $105 | $95 - $105 | ||
CBR revenue | $98 - $108 | $98 - $108 | $115 - $125 | $115 - $125 | ||
Total revenue | $503 - $553 | $523 - $553 | $520 - $570 | $540 - $570 | ||
Net income | $0 - $30 | $3 - $23 | $195 - $225 | $200 - $220 | ||
Operating income | $93 - $123 | $98 - $118 | N/A | N/A | ||
Adjusted EBITDA | N/A | N/A | $255 - $285 | $260 - $280 |
2 | See share count reconciliation at the conclusion of this press release. |
3 | See reconciliation of 2016 financial guidance of non-GAAP adjusted EBITDA and non-GAAP net income at the conclusion of this press release. |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Revenues: | ||||||||||||||||
Makena | $ | 93,387 | $ | 65,155 | $ | 236,824 | $ | 184,258 | ||||||||
Feraheme/MuGard | 22,390 | 23,762 | 71,500 | 66,726 | ||||||||||||
Cord Blood Registry | 27,965 | 7,177 | 71,863 | 7,177 | ||||||||||||
License fee, collaboration and other revenues | 40 | 58 | 313 | 51,380 | ||||||||||||
Total revenues | 143,782 | 96,152 | 380,500 | 309,541 | ||||||||||||
Operating costs and expenses: | ||||||||||||||||
Cost of product sales | 25,706 | 19,088 | 65,942 | 59,793 | ||||||||||||
Cost of services | 4,984 | 3,261 | 15,705 | 3,261 | ||||||||||||
Research and development expenses | 17,116 | 9,809 | 45,579 | 24,981 | ||||||||||||
Option rights to license orphan drug | — | 10,000 | — | 10,000 | ||||||||||||
Selling, general and administrative expenses | 57,216 | 46,141 | 172,314 | 110,054 | ||||||||||||
Impairment charges of intangible assets | — | — | 15,963 | — | ||||||||||||
Acquisition-related costs | — | 8,500 | — | 11,153 | ||||||||||||
Restructuring expenses | — | 738 | 712 | 1,752 | ||||||||||||
Total costs and expenses | 105,022 | 97,537 | 316,215 | 220,994 | ||||||||||||
Operating income | 38,760 | (1,385 | ) | 64,285 | 88,547 | |||||||||||
Other income (expense): | ||||||||||||||||
Interest expense | (18,309) | (14,222 | ) | (55,002 | ) | (34,794 | ) | |||||||||
Loss on debt extinguishment | — | (10,449 | ) | — | (10,449 | ) | ||||||||||
Interest and dividend income | 838 | 524 | 2,319 | 967 | ||||||||||||
Other income (expense) | (24 | ) | (9,182 | ) | 197 | (9,180 | ) | |||||||||
Total other income (expense) | (17,495 | ) | (33,329 | ) | (52,486 | ) | (53,456 | ) | ||||||||
Income (loss) before income taxes | 21,265 | (34,714 | ) | 11,799 | 35,091 | |||||||||||
Income tax expense (benefit) | 5,069 | (14,130 | ) | 3,725 | 9,513 | |||||||||||
Net income (loss) | $ | 16,196 | $ | (20,584 | ) | $ | 8,074 | $ | 25,578 | |||||||
Net income (loss) per share | ||||||||||||||||
Basic | $ | 0.47 | $ | (0.62 | ) | $ | 0.23 | $ | 0.84 | |||||||
Diluted | $ | 0.43 | $ | (0.62 | ) | $ | 0.23 | $ | 0.73 | |||||||
Weighted average shares outstanding used to compute net income (loss) per share: | ||||||||||||||||
Basic | 34,171 | 33,223 | 34,377 | 30,379 | ||||||||||||
Diluted | 42,111 | 33,223 | 34,764 | 34,962 |
September 30, 2016 | December 31, 2015 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 305,279 | $ | 228,705 | |||
Investments | 308,792 | 237,626 | |||||
Accounts receivable, net | 70,079 | 85,678 | |||||
Inventories | 38,157 | 40,645 | |||||
Receivable from collaboration | — | 428 | |||||
Prepaid and other current assets | 14,474 | 13,592 | |||||
Total current assets | 736,781 | 606,674 | |||||
Property, plant and equipment, net | 25,255 | 28,725 | |||||
Goodwill | 639,484 | 639,188 | |||||
Intangible assets, net | 1,122,535 | 1,196,771 | |||||
Restricted cash | 2,593 | 2,593 | |||||
Other long-term assets | 1,005 | 2,259 | |||||
Total assets | $ | 2,527,653 | $ | 2,476,210 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,742 | $ | 4,906 | |||
Accrued expenses | 126,363 | 106,363 | |||||
Current portion of long-term debt | 62,791 | 17,500 | |||||
Current portion of acquisition-related contingent consideration | 100,359 | 96,967 | |||||
Deferred revenues | 34,653 | 20,185 | |||||
Total current liabilities | 328,908 | 245,921 | |||||
Long-term liabilities: | |||||||
Long-term debt, net | 747,869 | 803,669 | |||||
Convertible 2.5% notes, net | 177,146 | 170,749 | |||||
Acquisition-related contingent consideration | 127,094 | 125,592 | |||||
Deferred tax liabilities | 192,608 | 189,145 | |||||
Deferred revenues | 12,513 | 5,093 | |||||
Other long-term liabilities | 3,562 | 3,777 | |||||
Total liabilities | 1,589,700 | 1,543,946 | |||||
Total stockholders’ equity | 937,953 | 932,264 | |||||
Total liabilities and stockholders’ equity | $ | 2,527,653 | $ | 2,476,210 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
GAAP revenues | $ | 143,782 | $ | 96,152 | $ | 380,500 | $ | 309,541 | ||||||||
Service revenues | 1,985 | 4 | 7,321 | 4 | 15,600 | 4 | 7,321 | 4 | ||||||||
License fee, collaboration and other revenues | — | — | — | (39,965 | ) | 5 | ||||||||||
Non-GAAP revenues | 145,767 | 103,473 | 396,100 | 276,897 | ||||||||||||
GAAP CBR revenues | 27,965 | 7,177 | 71,863 | 7,177 | ||||||||||||
Service revenues | 1,985 | 4 | 7,321 | 4 | 15,600 | 4 | 7,321 | 4 | ||||||||
Non-GAAP CBR revenues | 29,950 | 14,498 | 87,463 | 14,498 | ||||||||||||
GAAP costs of product sales and services | 30,690 | 22,349 | 81,647 | 63,054 | ||||||||||||
Cost of product sales | (20,915 | ) | 6 | (15,336 | ) | 6 | (53,151 | ) | 6 | (49,597 | ) | 6 | ||||
Cost of services | (359 | ) | 7 | (215 | ) | 7 | (1,072 | ) | 7 | (215 | ) | 7 | ||||
Non-GAAP costs of product sales and services | 9,416 | 6,798 | 27,424 | 13,242 | ||||||||||||
GAAP costs and expenses | 105,022 | 97,537 | 316,215 | 220,994 | ||||||||||||
Cost of product sales | (20,915 | ) | 6 | (15,336 | ) | 6 | (53,151 | ) | 6 | (49,597 | ) | 6 | ||||
Cost of services | (359 | ) | 7 | (215 | ) | 7 | (1,072 | ) | 7 | (215 | ) | 7 | ||||
Research and development expenses | (901 | ) | 8 | (1,550 | ) | 8 | (3,541 | ) | 8 | (3,241 | ) | 8 | ||||
Selling, general and administrative expenses | (13,244 | ) | 9 | (10,561 | ) | 9 | (33,971 | ) | 9 | (20,246 | ) | 9 | ||||
Option rights to license orphan drug | — | (10,000 | ) | 10 | — | (10,000 | ) | 10 | ||||||||
Impairment charges of intangible assets | — | — | (15,963 | ) | 11 | — | ||||||||||
Acquisition-related costs | — | (8,500 | ) | 12 | — | (11,153 | ) | 12 | ||||||||
Restructuring expenses | — | (738 | ) | 13 | (712 | ) | 13 | (1,752 | ) | 13 | ||||||
Non-GAAP costs and expenses | 69,603 | 50,637 | 207,805 | 124,790 | ||||||||||||
GAAP other income (expense), including income tax expense (benefit) | (22,564 | ) | (19,199 | ) | (56,211 | ) | (62,969 | ) | ||||||||
Non-cash interest expense | 3,171 | 14 | 3,111 | 14 | 9,333 | 14 | 8,943 | 14 | ||||||||
Loss on debt extinguishment | — | 10,449 | 15 | — | 10,449 | 15 | ||||||||||
Other income (expense) | — | 9,187 | 16 | — | 9,185 | 16 | ||||||||||
Income tax expense (benefit) | 5,069 | 17 | (14,130 | ) | 17 | 3,725 | 17 | 9,513 | 17 | |||||||
Non-GAAP other income (expense) | (14,324 | ) | (10,582 | ) | (43,153 | ) | (24,879 | ) | ||||||||
GAAP net income (loss) | 16,196 | (20,584 | ) | 8,074 | 25,578 | |||||||||||
Total adjustments | 45,644 | 62,838 | 137,068 | 101,650 | ||||||||||||
Non-GAAP net income (loss) | 61,840 | 42,254 | 145,142 | 127,228 |
4 | Represents purchase accounting adjustments related to deferred revenue in connection with the CBR acquisition. |
5 | Represents adjustments to exclude certain non-cash revenue associated with the 2014 termination of the company’s ex-US ferumoxytol marketing agreement. |
6 | Adjustments to eliminate the following: (i) non-cash step-up of inventory from purchase accounting; (ii) amortization expense related to intangible assets; (iii) depreciation expense; and (iv) stock-based compensation expense. |
7 | Adjustments to eliminate depreciation expense. |
8 | Adjustments to eliminate the following: (i) non-cash step-up of inventory used in research and development from purchase accounting; (ii) depreciation expense; and (iii) stock-based compensation expense. |
9 | Adjustments to eliminate the following: (i) non-cash adjustments related to contingent consideration; (ii) amortization expense related to intangible assets; (iii) depreciation expense; and (iv) stock-based compensation expense. |
10 | Eliminate one-time costs related to Velo option. |
11 | Impairment expense of $15.7 million related to the MuGard intangible asset and $0.2 million related to the favorable lease intangible asset |
12 | Adjustments to eliminate one-time costs related to CBR acquisition. |
13 | Adjustments to eliminate non-recurring restructuring costs. |
14 | Adjustments to eliminate non-cash interest expense. |
15 | Eliminate non-cash or one-time expenses related to the August 2015 term loan refinancing. |
16 | Eliminate one-time expenses related to the August 2015 debt financing. |
17 | Adjustments to eliminate non-cash income tax expense (benefit). |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
GAAP Net Income (Loss) | $ | 16,196 | $ | (20,584 | ) | $ | 8,074 | $ | 25,578 | ||||||
Adjustments: | |||||||||||||||
Interest expense, net | 17,471 | 13,698 | 52,683 | 33,827 | |||||||||||
Loss on debt extinguishment | — | 10,449 | — | 10,449 | |||||||||||
Other income | 24 | 9,182 | (197 | ) | 9,180 | ||||||||||
Provision for income tax | 5,069 | (14,130 | ) | 3,725 | 9,513 | ||||||||||
Operating income | 38,760 | (1,385 | ) | 64,285 | 88,547 | ||||||||||
Purchase accounting adjustments related to CBR deferred revenue | 1,985 | 7,321 | 15,600 | 7,321 | |||||||||||
Non-cash collaboration revenue | — | — | — | (39,965 | ) | ||||||||||
Depreciation and intangible asset amortization | 24,672 | 15,350 | 65,104 | 40,333 | |||||||||||
Non-cash inventory step-up adjustments | 1,573 | 2,122 | 4,718 | 11,948 | |||||||||||
Stock-based compensation | 5,468 | 4,889 | 16,808 | 11,572 | |||||||||||
Adjustments to contingent consideration | 3,708 | 2,886 | 5,106 | 4,525 | |||||||||||
Option rights to license orphan drug | — | 10,000 | — | 10,000 | |||||||||||
Impairment charges of intangible assets | — | — | 15,963 | — | |||||||||||
Acquisition-related costs | — | 10,901 | — | 13,735 | |||||||||||
Restructuring costs | — | 753 | 712 | 4,090 | |||||||||||
Non-GAAP adjusted EBITDA | 76,166 | 52,837 | 188,296 | 152,106 | |||||||||||
Cash interest | (14,323 | ) | (10,582 | ) | (43,154 | ) | (24,879 | ) | |||||||
Non-GAAP Net Income | $ | 61,843 | $ | 42,255 | $ | 145,142 | $ | 127,227 | |||||||
Basic: | |||||||||||||||
GAAP net income (loss) per share - Basic | $ | 0.47 | $ | (0.62 | ) | $ | 0.23 | $ | 0.84 | ||||||
Shares used in GAAP per share computation | 34,171 | 33,223 | 34,377 | 30,379 | |||||||||||
Non-GAAP net income per share - Basic | $ | 1.81 | $ | 1.27 | $ | 4.22 | $ | 4.19 | |||||||
Shares used in non-GAAP per share computation | 34,171 | 33,223 | 34,377 | 30,379 | |||||||||||
Diluted: | |||||||||||||||
GAAP net income (loss) per share - Diluted | $ | 0.43 | $ | (0.62 | ) | $ | 0.23 | $ | 0.73 | ||||||
Shares used in GAAP per share computation | 42,111 | 33,223 | 34,764 | 34,962 | |||||||||||
Non-GAAP net income per share - Diluted | $ | 1.78 | $ | 1.02 | $ | 4.18 | $ | 3.31 | |||||||
Shares used in non-GAAP per share computation | 34,730 | 41,229 | 34,764 | 38,430 |
2016 Financial Guidance | |||||
Previous | Updated | ||||
GAAP Net Income | $0 - $30 | $3 - $23 | |||
Adjustments: | |||||
Interest expense | 73 | 73 | |||
Provision for income tax | 20 | 22 | |||
Operating income | $93 - $123 | $98 - $118 | |||
Purchase accounting adjustments related to CBR deferred revenue | 17 | 17 | |||
Depreciation and intangible asset amortization | 91 | 91 | |||
Non-cash inventory step-up adjustments | 5 | 5 | |||
Stock-based compensation | 26 | 26 | |||
Adjustments to contingent consideration | 6 | 6 | |||
Impairment charges of intangible assets | 16 | 16 | |||
Restructuring costs | 1 | 1 | |||
Non-GAAP adjusted EBITDA | $255 - $285 | $260 - $280 | |||
Cash interest | (60 | ) | (60 | ) | |
Non-GAAP Net Income | $195 - $225 | $200 - $220 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Weighted average basic shares outstanding | 34.2 | 33.2 | 34.4 | 30.4 | |||||||||||||
Employee equity incentive awards | 0.5 | — | 18 | 0.4 | 1.6 | ||||||||||||
Convertible notes | 7.4 | — | 18 | — | 18 | — | 18 | ||||||||||
Warrants | — | 18 | — | 18 | — | 18 | 3.0 | ||||||||||
GAAP diluted shares outstanding | 42.1 | 33.2 | 34.8 | 35.0 | |||||||||||||
Employee equity incentive awards | — | 1.5 | 19 | — | — | ||||||||||||
Convertible notes | (7.4 | ) | 19 | 7.4 | 19 | — | 7.4 | 19 | |||||||||
Effect of bond hedge and warrants | — | (0.9 | ) | 20 | — | (4.0 | ) | 20 | |||||||||
Non-GAAP diluted shares outstanding | 34.7 | 41.2 | 34.8 | 38.4 |
18 | Employee equity incentive awards, convertible notes and warrants would be anti-dilutive in this period utilizing the “if-converted” method, which adjusts net income for the after-tax interest expense applicable to the convertible notes. |
19 | Reflects the Non-GAAP dilutive impact of employee equity incentive awards and convertible notes. |
20 | Reflects the impact of the non-GAAP benefit of the bond hedge and warrants. |
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