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As Of Filer Filing For·On·As Docs:Size 8/05/15 PDL Biopharma, Inc. 8-K:2,7,9 8/05/15 4:2.6M |
Document/Exhibit Description Pages Size 1: 8-K Current Report HTML 20K 2: EX-99.1 Press Release HTML 61K 3: EX-99.2 Presentation HTML 7K 4: EX-99.3 Information Sheet HTML 145K
PDLI-2015.08.05-8-K EX 99.3 |
• | On
July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 3.263 billion and increased by 9%. |
◦ | EU: Growth driven by ovarian and cervical cancer, the latter of which was approval in 1Q15. |
◦ | US: Sales largely driven by ovarian, cervical and first line colorectal cancer. |
◦ | Japan:
Growth in all indications. |
◦ | International: Strong growth in all regions, especially Latin America. |
• | On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 3.265 billion and increased by 11%. |
◦ | US:
Strong growth in first line metastatic breast cancer due to longer treatment times. |
◦ | EU: Stable sales with continuing conversion to subcutaneous formulation. |
◦ | International: Strong growth in all regions. |
• | On
July 23, 2015, Genentech/Roche reported that 1H15 US sales were CHF 593 million and increased by 28%. |
◦ | Growth in allergic asthma and chronic idiopathic urticaria (hives). |
• | On July 21, 2015, Novartis reported that 2Q15 ex-US sales were $194 million and increased by 18%. |
• | On July 24, 2015, Biogen reported that 2Q15 worldwide sales were $463 million, flat from 1Q15 but decreased by 13% from 2Q14. |
• | On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 659 million and increased by 72%. |
◦ | Perjeta sales grew in all regions, driven by US in the neoadjuvant and metastatic breast cancer settings, and EU in the metastatic breast cancer setting. |
◦ | Approved
in all major markets for first line metastatic breast cancer. |
◦ | Approved in US and 20 markets for neoadjuvant setting with positive CHMP opinion in neoadjuvant setting in 1Q15. |
◦ | Benefiting from increase in overall survival in first line metastatic breast cancer when combined with Herceptin and docetaxel which data was added to US label in 1Q15. |
• | On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 362 million and increased by 65%. |
◦ | EU and International: Strong uptake in second line metastatic breast cancer. |
• | Data
expected from Phase 2/3 trial in HER2+ gastric cancer (GATSBY) in 2H15. |
• | On July 22, 2015 at a healthcare conference focused on Alzheimer’s Disease, Lilly presented two year data from an extension study of two earlier Phase 3 studies of solanezumab. These studies included patients with mild and moderate Alzheimer’s Disease, and while they did not meet the primary efficacy endpoint, they did show benefit in patients with mild disease.
The two year extension study utilized a delayed start analysis. The new data suggest that patients who started solanezumab earlier retained an advantage in cognition and daily function over those who started later and that the difference persisted for two years. Lilly commenced a new Phase 3 trial in patients with only mild Alzheimer's Disease in 2013. On April 23, 2015, Lilly stated that this Phase 3 trial was fully enrolled with the last patient visit expected in 4Q16 and topline results thereafter. Because of the difficulty in distinguishing between patients with dementia and those with Alzheimer's Disease, Lilly used PET scans or similar screens to test patients before enrolling them in this new Phase 3 trial. The screens differentiate between patients with beta amyloid buildup = Alzheimer's Disease and who should be in the trial versus those without beta amyloid buildup = dementia and who should not be in the trial.
Lilly estimates that scans will increase patient enrollment failures from less than 25% to more than 50% - a good thing because it enriches the patient population with those most likely to benefit from solanezumab. PDL has a know-how royalty on solanezumab which extends beyond the expiration of the Queen patents. This is because PDL helped to design solanezumab. If solanezumab is approved, PDL would receive a 2% royalty for 12.5 years from the date of its first sale. |
Queen et al. Royalties | ||||||||||
Royalty Revenue by Product
($ in 000's) * | ||||||||||
Avastin | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 38,809 | 38,447 | — | — | 77,256 | |||||
2014 | 38,122 | 38,924 | 38,864 | 40,723 | 156,632 | |||||
2013 | 33,234 | 46,720 | 32,224 | 32,287 | 144,464 | |||||
2012 | 23,215 | 41,670 | 25,955 | 30,041 | 120,882 | |||||
2011 | 22,283 | 41,967 | 23,870 | 22,886 | 111,006 | |||||
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 | |||||
2015 | 37,875 | 39,476 | — | — | 77,351 | |||||
2014 | 36,646 | 38,292 | 39,407 | 40,049 | 154,394 | |||||
2013 | 30,287 | 47,353 | 30,961 | 33,038 | 141,640 | |||||
2012 | 25,702 | 44,628 | 30,433 | 28,307 | 129,070 | |||||
2011 | 25,089 | 42,209 | 31,933 | 21,812 | 121,042 | |||||
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 | |||||
2015 | 15,920 | — | — | — | 15,920 | |||||
2014 | 17,390 | 16,777 | 16,883 | 16,695 | 67,746 | |||||
2013 | 12,032 | 30,066 | 13,536 | 12,127 | 67,760 | |||||
2012 | 10,791 | 27,938 | 12,552 | 11,097 | 62,377 | |||||
2011 | 8,878 | 24,313 | 12,157 | 10,750 | 56,099 | |||||
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 | |||||
2015 | 10,971 | 11,075 | — | — | 22,046 | |||||
2014 | 8,886 | 9,099 | 10,442 | 11,237 | 39,663 | |||||
2013 | 5,930 | 10,025 | 7,334 | 7,330 | 30,619 | |||||
2012 | 5,447 | 8,609 | 6,504 | 6,145 | 26,705 | |||||
2011 | 4,590 | 7,621 | 5,916 | 5,823 | 23,949 | |||||
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 | |||||
Perjeta | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 6,596 | 7,419 | — | — | 14,015 | |||||
2014 | 3,375 | 4,385 | 5,157 | 5,850 | 18,767 | |||||
2013 | 340 | 1,414 | 748 | 879 | 3,381 | |||||
2012 | — | — | 58 | 250 | 308 |
Queen et al. Royalties | ||||||||||
Royalty Revenue by Product
($ in 000's) * | ||||||||||
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 3,852 | 4,177 | — | — | 8,029 | |||||
2014 | 1,934 | 2,491 | 3,048 | 3,464 | 10,937 | |||||
2013 | — | 551 | 830 | 859 | 2,240 | |||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 14,385 | 13,614 | — | — | 27,999 | |||||
2014 | 12,857 | 13,350 | 16,048 | 15,015 | 57,270 | |||||
2013 | 12,965 | 13,616 | 11,622 | 12,100 | 50,304 | |||||
2012 | 11,233 | 12,202 | 11,749 | 12,255 | 47,439 | |||||
2011 | 9,891 | 10,796 | 11,588 | 11,450 | 43,725 | |||||
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 | |||||
Actemra | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 4,990 | — | — | — | 4,990 | |||||
2014 | 3,446 | 3,932 | 4,419 | 5,406 | 17,202 | |||||
2013 | 2,631 | 2,816 | 2,939 | 3,744 | 12,131 | |||||
2012 | 1,705 | 2,074 | 2,145 | 2,462 | 8,385 | |||||
2011 | 913 | 1,136 | 1,401 | 1,460 | 4,910 | |||||
2010 | 1,587 | 237 | 315 | 688 | 2,827 | |||||
2009 | 585 | 537 | 909 | 1,197 | 3,228 | |||||
2008 | 44 | — | 146 | 369 | 559 | |||||
2007 | 32 | — | — | 17 | 49 | |||||
Gazyva | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 313 | — | — | — | 313 | |||||
2014 | 51 | 283 | 325 | 436 | 1,094 | |||||
Entyvio | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 2,223 | — | — | — | 2,223 | |||||
2014 | — | — | 153 | 2,192 | 2,344 | |||||
* As
reported to PDL by its licensees. Totals may not sum due to rounding. | ||||||||||
Q1 2014 royalty revenue by product above do not include a $5 million payment received from Genentech in Q1 2014 for a retroactive settlement payment from 2013. |
Queen
et al. Sales Revenue | ||||||||||
Reported Licensee Net Sales Revenue by Product ($ in 000's) * | ||||||||||
Avastin | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 1,826,289 | 1,809,286 | — | — | 3,635,575 | |||||
2014 | 1,786,912 | 1,838,764 | 1,828,900 | 1,916,353 | 7,370,929 | |||||
2013 | 1,653,108 | 1,694,678 | 1,746,135 | 1,819,877 | 6,913,798 | |||||
2012 | 1,502,757 | 1,573,727 | 1,551,327 | 1,662,977 | 6,290,788 | |||||
2011 | 1,597,461 | 1,582,705 | 1,581,095 | 1,469,994 | 6,231,255 | |||||
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 | |||||
2015 | 1,789,404 | 1,857,696 | — | — | 3,647,100 | |||||
2014 | 1,731,564 | 1,801,990 | 1,854,452 | 1,877,614 | 7,265,621 | |||||
2013 | 1,681,574 | 1,744,145 | 1,681,860 | 1,726,551 | 6,834,130 | |||||
2012 | 1,515,255 | 1,625,313 | 1,663,695 | 1,650,495 | 6,454,759 | |||||
2011 | 1,391,568 | 1,559,975 | 1,642,898 | 1,432,771 | 6,027,211 | |||||
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 | |||||
2015 | 749,182 | — | — | — | 749,182 | |||||
2014 | 818,376 | 789,483 | 794,505 | 785,669 | 3,188,031 | |||||
2013 | 1,203,179 | 1,171,423 | 1,200,791 | 1,212,651 | 4,788,045 | |||||
2012 | 1,079,092 | 1,086,543 | 1,097,541 | 1,109,695 | 4,372,871 | |||||
2011 | 887,757 | 943,418 | 1,052,809 | 1,075,015 | 3,958,999 | |||||
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 | |||||
2015 | 523,340 | 521,192 | — | — | 1,044,532 | |||||
2014 | 425,243 | 428,171 | 491,372 | 521,726 | 1,866,512 | |||||
2013 | 341,309 | 365,778 | 391,900 | 401,333 | 1,500,321 | |||||
2012 | 310,234 | 314,638 | 347,796 | 340,431 | 1,313,100 | |||||
2011 | 267,754 | 277,642 | 310,874 | 314,911 | 1,171,182 | |||||
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 | |||||
Perjeta | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 310,410 | 349,125 | — | — | 659,535 | |||||
2014 | 158,809 | 206,333 | 242,700 | 275,311 | 883,153 | |||||
2013 | 34,008 | 55,076 | 66,353 | 87,949 | 243,386 | |||||
2012 | — | — | 5,080 | 25,000 | 30,079 |
Queen et al. Sales Revenue | ||||||||||
Reported Licensee
Net Sales Revenue by Product ($ in 000's) * | ||||||||||
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 181,275 | 196,556 | — | — | 377,831 | |||||
2014 | 91,031 | 117,212 | 143,414 | 163,028 | 514,685 | |||||
2013 | — | 21,459 | 73,626 | 85,906 | 180,991 | |||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 479,526 | 453,786 | — | — | 933,312 | |||||
2014 | 428,561 | 442,492 | 534,946 | 500,511 | 1,906,510 | |||||
2013 | 434,677 | 451,358 | 387,407 | 403,334 | 1,676,776 | |||||
2012 | 374,430 | 401,743 | 391,623 | 408,711 | 1,576,508 | |||||
2011 | 329,696 | 356,876 | 388,758 | 381,618 | 1,456,948 | |||||
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 | |||||
Actemra | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 166,338 | — | — | — | 166,338 | |||||
2014 | 114,865 | 124,736 | 147,285 | 180,197 | 567,082 | |||||
2013 | 87,703 | 91,374 | 97,961 | 124,815 | 401,852 | |||||
2012 | 56,662 | 66,624 | 71,505 | 82,053 | 276,843 | |||||
2011 | 30,433 | 35,370 | 46,709 | 48,671 | 161,183 | |||||
2010 | 52,908 | 5,405 | 10,493 | 22,919 | 91,725 | |||||
2009 | 19,504 | 17,920 | 30,313 | 39,888 | 107,625 | |||||
2008 | 1,452 | 1,377 | 5,981 | 12,305 | 21,115 | |||||
2007 | — | — | — | 1,137 | 1,137 | |||||
Gazyva | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 9,627 | — | — | — | 9,627 | |||||
2014 | 3,095 | 8,697 | 11,531 | 13,428 | 36,750 | |||||
Entyvio | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 59,287 | — | — | — | 59,287 | |||||
2014 | — | — | 5,347 | 58,500 | 63,848 | |||||
* As
reported to PDL by its licensee. Dates in above charts reflect when PDL receives | ||||||||||
royalties on sales. Sales occurred in the quarter prior to the dates in the above charts. | ||||||||||
Totals may not sum due to rounding. |
This ‘8-K’ Filing | Date | Other Filings | ||
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1/1/19 | ||||
12/31/18 | ||||
Filed on / For Period End: | 8/5/15 | |||
7/28/15 | 8-K | |||
7/24/15 | ||||
7/23/15 | ||||
7/22/15 | ||||
7/21/15 | ||||
4/23/15 | 8-K | |||
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