Delaware | 94-3023969 | |
(State or Other Jurisdiction of Incorporation) | (I.R.S. Employer Identification No.) |
Exhibit No. | Description | |
99.1 | Press Release | |
99.2 | Presentation | |
99.3 | 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 | Press Release | |
99.2 | Presentation | |
99.3 | Information Sheet |
Contacts: | ||
Peter Garcia | Jennifer Williams | |
PDL BioPharma, Inc. | Cook Williams Communications, Inc. | |
775-832-8500 | 360-668-3701 | |
Peter.Garcia@pdl.com | jennifer@cwcomm.org |
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Revenues | ||||||||
Royalties from Queen et al. patents | $ | 127,810 | $ | 116,026 | ||||
Royalty rights - change in fair value | 11,362 | 11,707 | ||||||
Interest revenue | 10,534 | 9,071 | ||||||
Total revenues | 149,706 | 136,804 | ||||||
Operating Expenses | ||||||||
General and administrative expenses | 7,666 | 4,582 | ||||||
Operating income | 142,040 | 132,222 | ||||||
Non-operating expense, net | ||||||||
Interest and other income, net | 86 | 50 | ||||||
Interest expense | (8,610 | ) | (10,525 | ) | ||||
Loss on extinguishment of debt | — | (6,143 | ) | |||||
Total non-operating expense, net | (8,524 | ) | (16,618 | ) | ||||
Income before income taxes | 133,516 | 115,604 | ||||||
Income tax expense | 49,018 | 42,721 | ||||||
Net income | $ | 84,498 | $ | 72,883 | ||||
Net income per share | ||||||||
Basic | $ | 0.52 | $ | 0.48 | ||||
Diluted | $ | 0.50 | $ | 0.44 | ||||
Shares used to compute income per basic share | 162,829 | 151,198 | ||||||
Shares used to compute income per diluted share | 170,412 | 164,571 | ||||||
Cash dividends declared per common share | $ | 0.60 | $ | 0.60 |
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
Cash, cash equivalents and investments | $ | 418,920 | $ | 293,687 | ||||
Total notes receivable | $ | 365,806 | $ | 363,212 | ||||
Total royalty rights - at fair value | $ | 269,668 | $ | 259,244 | ||||
Total assets | $ | 1,114,133 | $ | 962,350 | ||||
Total term loan payable | $ | 99,393 | $ | — | ||||
Total convertible notes payable | $ | 432,567 | $ | 451,724 | ||||
Total stockholders' equity | $ | 451,944 | $ | 460,437 |
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Net income | $ | 84,498 | $ | 72,883 | ||||
Adjustments to reconcile net income to net cash provided by (used in) operating activities | (3,442 | ) | (1,612 | ) | ||||
Changes in assets and liabilities | (9,210 | ) | (3,130 | ) | ||||
Net cash provided by operating activities | $ | 71,846 | $ | 68,141 |
• | On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 1.61 billion and increased by 6%. |
◦ | EU: Growth driven by further uptake in ovarian and breast cancer. |
◦ | US: Sales largely driven by cervical, ovarian and lung cancer. |
◦ | Japan: Growth in all indications. |
◦ | International: Strong growth in all regions. |
• | On August 14, 2014 and April 8, 2015, Genentech/Roche announced US and EU approval for the treatment of persistent, recurrent or metastatic cervical cancer in combination with chemotherapy, respectively. |
• | On August 6, 2014 and November 14, 2014, Genentech/Roche announced EU and US approval for the treatment of recurrent platinum-resistant ovarian cancer, respectively. |
• | On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 1.652 billion and increased by 12%. |
◦ | 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 Latin America due to access to public markets and in China due to patient assistance program. |
• | On April 23, 2015, Novartis reported that 1Q15 ex-US sales were $539 million and were flat. |
• | On April 22, 2015, Genentech/Roche reported that 1Q15 US sales were CHF 281 million and increased by 28%. |
◦ | Growth in asthma and chronic idiopathic urticaria (hives) post-FDA approval in 1Q14. |
• | On April 23, 2015, Novartis reported that 1Q15 ex-US sales were $180 million and increased by 22%. |
• | On April 24, 2015, Biogen reported that 1Q15 worldwide sales were $463 million and increased by 5%. |
• | On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 334 million and increased by 27%. |
◦ | EU: Strong uptake in first line monotherapy and subcutaneous launch. |
◦ | US: Over 35% growth driven by continued uptake of new subcutaneous formulation. |
◦ | International: Over 55% growth driven by all regions, especially Latin America. |
• | On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 322 million and increased by 82%. |
◦ | Perjeta sales grew in all regions with strong uptake in the US, Germany and France. |
◦ | 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 and neoadjuvant indication approved in US and 17 countries. |
• | On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 179 million and increased by 80%. |
• | EU: Strong uptake in second line metastatic breast cancer. |
• | On December 18, 2014, Genentech reported that the two Kadcyla arms in MARIANNE trial in first line metastatic breast cancer failed to demonstrate superiority over Herceptin + chemotherapy. This does not affect its current approval as second line treatment for HER2+ metastatic breast cancer. |
• | On April 23, 2015, Lilly stated that its new Phase 3 trial in patients with mild Alzheimer’s Disease is fully enrolled with the last patient visit expected in October 2016 and topline results thereafter. |
• | Lilly also stated that two year data from the extension of its earlier Phase 3 Expedition trials in patients with mild-to-moderate Alzheimer’s Disease will be available in the middle of this year, that disease modification is the focus of the dataset and that they will break out patients with mild disease in the analysis. |
◦ | Unlike in the new Phase 3, Lilly did not use PET scans or similar tests to screen potential trial enrollees for beta amyloid build up. |
• | If solanezumab were to receive marketing authorization, PDL would receive a 12.5 year know-how royalty of 2% from date of first sale. |
• | Effective April 1, 2015 Valeant Pharmaceuticals International, Inc. completed its acquisition of Salix Pharmaceuticals. |
• | Current royalty bearing products include: |
◦ | Glumetza (U.S, sold by Salix/Valeant Pharmaceuticals) |
◦ | Glumetza (Canada, sold by Valeant Pharmaceuticals) |
◦ | Glumetza (Korea, sold by LG Life Sciences) |
◦ | Janumet XR (world-wide, Sold by Merck) |
• | Additional products for which we may receive milestones and royalties: |
◦ | Combination of Invokana® (canagliflozin) and extended-release metformin (Janssen Pharmaceutica) |
◦ | Two investigational fixed-dose combinations of drugs and extended-release metformin (Boehringer Ingelheim) |
• | In the first quarter of 2015 we recorded a $9.1 million increase in revenue related to the royalty rights- change in fair value of the Depomed asset, which included a net cash payment of approximately $0.5 million. PDL expects that the sales of Glumetza in the U.S., and therefore royalties on such sales paid to the Company, will be minimal through the second quarter of 2015 as distributors continue to reduce their excess levels of inventory of Glumetza. |
• | Our forecast of $49 million in cash receipts in 2015 related to the Depomed transaction remains unchanged from estimates given in February of 2015. |
• | Since inception of the transaction (October 2013) to date we have received $113.5 million in cash from this transaction. |
Queen et al. Royalties | ||||||||||
Royalty Revenue by Product ($ in 000's) * | ||||||||||
Avastin | Q1 | Q2 | Q3 | Q4 | Total | |||||
2015 | 38,809 | — | — | — | 38,809 | |||||
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 | — | — | — | 37,875 | |||||
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 | — | — | — | 10,971 | |||||
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 | — | — | — | 6,596 | |||||
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 | — | — | — | 3,852 | |||||
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 | — | — | — | 14,385 | |||||
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 | — | — | — | 1,826,289 | |||||
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 | — | — | — | 1,789,404 | |||||
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 | — | — | — | 523,340 | |||||
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 | — | — | — | 310,410 | |||||
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 | — | — | — | 181,275 | |||||
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 | — | — | — | 479,526 | |||||
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. |