Delaware | 94-3023969 | |
(State or Other Jurisdiction of Incorporation) | (I.R.S. Employer Identification No.) |
Exhibit No. | Description | |
99.1 | Presentation | |
99.2 | Information Sheet |
PDL BIOPHARMA, INC. | ||
(Company) | ||
By: | /s/ Peter S. Garcia | |
Peter S. Garcia | ||
Vice President and Chief Financial Officer | ||
Exhibit No. | Description | |
99.1 | Presentation | |
99.2 | Information Sheet |
• | On January 29, 2014, PDL’s Board of Directors declared regular quarterly dividends of $0.15 per share of common stock, payable on March 12, June 12, September 12 and December 12 of 2014 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2014, the record dates for each of the dividend payments, respectively. On June 12, 2014, PDL paid the second quarterly dividend to stockholders of record totaling $24.0 million using earnings generated in the second quarter of 2014. |
• | In the second quarter of 2014, after consultation with our auditor’s and the Office of Chief Accountant of the SEC, PDL recorded a change in accounting related to its acquisition of royalty rights from Depomed. As part of this change, PDL has elected to measure these assets at fair value. The change in fair value along with net cash royalties received from Depomed is currently presented as a component of “royalty rights - change in fair value” in PDL’s condensed consolidated statements of income. Of the $34.5 million recognized in royalty rights for the quarter ended June 30, 2014, $25.8 million were net cash royalty receipts from Depomed and $8.7 million was the net increase in fair value including prior period adjustments. |
• | The cost of revenue caption, previously reported in the first quarter of 2014 was reversed in the second quarter and will no longer be reported. |
• | The change in accounting is further described in Correction of an Immaterial Error section below. |
• | In recognition of its transitioning business model to acquire new revenue generating assets, PDL reclassified $12.6 million in interest income in the quarter ended June 30, 2014 related to interest from its notes receivable to interest revenue, which compares to $4.9 million in interest revenue for the second quarter of 2013. The reclassification of $21.7miilion and $8.7milllion was also made for the six months ended June 30, 2014 and 2013, respectively. |
• | The second quarter 2014 royalty payment received from Genentech products was for worldwide net sales in the first quarter 2014. Prior to 2014, PDL's second quarter royalty revenue was historically the highest amount of any quarter because the applicable tiered royalty rate was three percent. However, as aggregate net sales increased with each subsequent quarter, the tiered royalty rate declined, dropping to one percent in PDL’s third, fourth and first quarters. As a result, the blended royalty rate for all of 2013 for Genentech Products was 1.9 percent. The settlement with Genentech resulted in a single fixed royalty rate of 2.125 percent, which results in more uniform royalty revenue on a quarter to-quarter basis in the current fiscal year. Thus, this decrease in Queen et al. related royalties between the second quarters of 2013 and 2014 is a function of the transition to the new fixed royalty rate, which new royalty rate is anticipated to result in greater royalties to PDL when measured on an annual basis |
• | On July 24, 2014, Genentech/Roche reported that 1H14 worldwide sales were $3.778 billion* and increased by 6%. |
• | On July 21, 2014, Genentech announced that its application for approval for the treatment of recurrent platinum-resistant ovarian cancer in US had been granted priority review with a PDUFA date of November 19, 2014. |
• | On August 6, 2014, Roche reported EU approval for the treatment of ovarian cancer that is resistant to platinum-based chemotherapy. |
• | On August 14, 2014, Genentech announced US approval for the treatment of persistent, recurrent or metastatic cervical cancer in the US in combination with chemotherapy. |
• | On July 24, 2014, Genentech/Roche reported that 1H14 worldwide sales were $3.76 billion* and increased by 6%. |
• | Subcutaneous formulation being rapidly adopted in vast majority of EU. |
• | On July 24, 2014, Genentech/Roche reported that 1H14 US sales were $1 billion* and increased by 6%. |
◦ | AMD and RVO: Stable use and increasing size of market but potential competition in BRVO in 2H14. |
◦ | DME: Increasing patient share but also expecting competition in 2H14. |
• | On July 17, 2014, Novartis reported that 2Q14 ex-US sales were $619 million and increased by 7% over 2Q13. |
• | On August 7, 2014, Genentech filed in US for approval for treatment of diabetic retinopathy. |
◦ | Diabetic retinopathy is the leading cause of new cases of blindness of working-age people. |
• | On July 23, 2014, Biogen Idec reported that 2Q14 worldwide sales were $533 million. |
• | On July 24, 2014, Genentech/Roche reported that 1H14 US sales were $533 million* and increased by 19%. |
• | On July 17, 2014, Novartis reported that 2Q14 ex-US sales were $197 million and increased by 30% over 2Q13. |
• | On March 6, 2014, Novartis reported that the EU had approved Xolair as an add on therapy for chronic spontaneous idiopathic urticaria. |
• | On March 21, 2014, Genentech/Roche announced that the FDA had approved Xolair for chronic idiopathic urticaria. |
• | On July 24, 2014, Genentech/Roche reported that 1H14 worldwide sales were $693 million* and increased by 22% year over year. |
• | On April 28, 2014, Roche announced approval of the subcutaneous formulation in EU. |
• | On October 21, 2013, Genentech/Roche announced approval of the subcutaneous formulation in US. |
• | On July 24, 2014, Genentech/Roche reported 1H14 worldwide sales were $473 million* and increased by 276% year over year. |
• | On July 24, 2014, Genentech/Roche reported 1H14 worldwide sales were $277 million* and increased by 188%. |
• | On July 24, 2014, Genentech/Roche announced 1H14 US sales of $22 million. |
◦ | Gazyva was approved in the US on November 1, 2013, for previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil. |
• | On July 29, 2014, Roche announced EU approval for first line treatment of CLL with chlorambucil. |
For the year ended December 31, 2013 (in thousands) | |||||||||||||||
Amounts in 000's | As Filed | Adjustments | As Corrected | % Change | |||||||||||
Total Revenues | $ | 442,921 | $ | 190 | $ | 443,111 | 0 | % | |||||||
Operating Income | $ | 407,529 | $ | 5,013 | $ | 412,542 | 1.2 | % | |||||||
Pre-tax Income | $ | 401,876 | $ | 5,013 | $ | 406,889 | 1.2 | % | |||||||
Net Income | $ | 264,530 | $ | 3,184 | $ | 267,714 | 1.2 | % | |||||||
EPS: | |||||||||||||||
Basic | $ | 1.89 | $ | 0.02 | $ | 1.91 | 1.1 | % | |||||||
Diluted | $ | 1.66 | $ | 0.02 | $ | 1.68 | 1.2 | % |
For the three months ended March 31, 2014 (in thousands) | |||||||||||||||
Amounts in 000's | As Filed | Adjustments | As Corrected | % Change | |||||||||||
Total Revenues | $ | 139,664 | $ | 1,669 | $ | 141,333 | 1.2 | % | |||||||
Operating Income | $ | 123,151 | $ | 12,786 | $ | 135,937 | 10.4 | % | |||||||
Pre-tax Income | $ | 115,604 | $ | 12,786 | $ | 128,390 | 11.1 | % | |||||||
Net Income | $ | 72,883 | $ | 8,121 | $ | 81,004 | 11.1 | % | |||||||
EPS: | |||||||||||||||
Basic | $ | 0.48 | $ | 0.05 | $ | 0.53 | 10.4 | % | |||||||
Diluted | $ | 0.44 | $ | 0.05 | $ | 0.49 | 11.4 | % |
Royalty Revenue by Product ($ in 000's) * | ||||||||||
Avastin | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 40,538 | 38,924 | — | — | 79,462 | |||||
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 | |||||
2014 | 37,863 | 38,292 | — | — | 76,155 | |||||
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 | |||||
2014 | 17,104 | 16,777 | — | — | 33,881 | |||||
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 | |||||
2014 | 9,559 | 9,099 | — | — | 18,658 | |||||
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 | |||||
2014 | 3,892 | 4,385 | — | — | 8,277 | |||||
2013 | 340 | 1,414 | 748 | 879 | 3,381 | |||||
2012 | — | — | 58 | 250 | 308 |
Royalty Revenue by Product ($ in 000's) * | ||||||||||
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 2,393 | 2,491 | — | — | 4,884 | |||||
2013 | — | 551 | 830 | 859 | 2,240 | |||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 12,857 | 13,350 | — | — | 26,207 | |||||
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 | |||||
2014 | 3,446 | 3,932 | — | — | 7,378 | |||||
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 | |||||
2006 | — | — | — | — | — | |||||
Gazyva | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 51 | 283 | — | — | 334 | |||||
* 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 $5 million payment received from Genentech in Q1 2014 for a retroactive settlement payment from 2013. |
Reported Net Sales Revenue by Product ($ in 000's) * | ||||||||||
Avastin | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 1,786,912 | 1,838,764 | — | — | 3,625,676 | |||||
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 | |||||
2014 | 1,731,564 | 1,801,990 | — | — | 3,533,554 | |||||
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 | |||||
2014 | 818,376 | 789,483 | — | — | 1,607,859 | |||||
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 | |||||
2014 | 425,243 | 428,171 | — | — | 853,414 | |||||
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 | |||||
2014 | 158,809 | 206,333 | — | — | 365,142 | |||||
2013 | 34,008 | 55,076 | 66,353 | 87,949 | 243,386 | |||||
2012 | — | — | 5,080 | 25,000 | 30,079 |
Reported Net Sales Revenue by Product ($ in 000's) * | ||||||||||
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 91,031 | 117,212 | — | — | 208,243 | |||||
2013 | — | 21,459 | 73,626 | 85,906 | 180,991 | |||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2014 | 428,561 | 442,492 | — | — | 871,053 | |||||
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 | |||||
2014 | 114,865 | 124,736 | — | — | ||||||
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 | |||||
2014 | 3,095 | 8,697 | — | — | 11,792 | |||||
* As reported to PDL by its licensee | ||||||||||
Totals may not sum due to rounding |