Exhibit 99.3
PDL BioPharma, Inc.
Q2 2015
August 5, 2015
Following are some of the key points regarding PDL’s second quarter 2015 financial and business results.
Net Income
Net income in the second quarter of 2015 was $78.3 million, or $0.47 per diluted share as compared with net income in the second quarter of 2014 of $92.1 million, or $0.52 per diluted share.
ARIAD Revenue Interest Assignment
On July 28, 2015, the Company entered into a revenue interest assignment agreement (the “Agreement”) in which it agreed to provide ARIAD Pharmaceuticals, Inc. ("ARIAD") with up to $200 million in cash in exchange for royalties on the net revenues of Iclusig® (ponatinib). Funding of the first $100 million will be made in two tranches of $50 million each, with the initial amount having already been funded on the closing date of the Agreement and an additional $50 million to be funded on the 12-month anniversary of the closing date. In addition, ARIAD has an option to draw up to an additional $100 million at any time between the six and twelve month anniversaries of the closing date.
PDL will initially receive 2.5% of the worldwide net revenues of Iclusig until the 12-month anniversary of the closing date, at which time the royalty increases to 5.0% of the worldwide net revenues of Iclusig and remains until December 31, 2018. Beginning January 1, 2019 and thereafter, the royalty rate will increase to 6.5%, subject to an additional increase to 7.5% if PDL’s funding exceeds $150 million.
If PDL does not receive payments equal to or greater than the total amount funded on or before the fifth anniversary of each of the respective fundings, ARIAD will pay PDL make-whole payments calculated as the difference between the amounts funded by PDL and the amounts paid to PDL to such date. In addition, if the net revenues from Iclusig do not reach certain agreed-upon projections in future years, PDL has a right to the same percentage of net revenues from brigatinib.
PDL has a put option based upon certain events and ARIAD has a call option to repurchase the revenue interest at any time. The financial terms for the put and call are the same: the greater of a 10% IRR or 1.5 times cash-on-cash in year one, 1.2 times cash-on-cash in year two and 1.3 times cash-on-cash in year three and beyond.
Updates on Approved Royalty Bearing Products related to Queen et al. patents
Avastin® (bevacizumab):
| |
• | 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. |
Herceptin® (trastuzumab):
| |
• | 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. |
Xolair® (omalizumab):
| |
• | 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%. |
PDL BioPharma, Inc.
Q2 2015
August 5, 2015
Tysabri® (natalizumab):
| |
• | On July 24, 2015, Biogen reported that 2Q15 worldwide sales were $463 million, flat from 1Q15 but decreased by 13% from 2Q14. |
Perjeta® (pertuzumab):
| |
• | 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. |
Kadcyla® (TDM-1 or ado-trastuzumab emtansine):
| |
• | 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. |
Updates on Unapproved Royalty Bearing Products Related to Queen et al. patents
Solanezumab
| |
• | 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. |
Forward-looking Statements
This document contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new income generating assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward looking statement except as required by law.
PDL BioPharma, Inc.
Q2 2015
August 5, 2015
|
| | | | | | | | | | |
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 |
|
PDL BioPharma, Inc.
Q2 2015
August 5, 2015
|
| | | | | | | | | | |
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 $5 million payment received from Genentech in Q1 2014 for a retroactive settlement payment from 2013. |
PDL BioPharma, Inc.
Q2 2015
August 5, 2015
|
| | | | | | | | | | |
Queen et al. Sales Revenue |
Reported Licensee Net Sales Revenue by Product ($ 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 |
|
PDL BioPharma, Inc.
Q2 2015
August 5, 2015
|
| | | | | | | | | | |
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. | |