Exhibit 99.3
PDL BioPharma, Inc.
Q3-2013
November 6, 2013
Following are some of the key points regarding PDL’s third quarter 2013 financial and business results.
Net Income
| |
• | Net income for the third quarter of 2013 was $56.2 million, or $0.36 per diluted share, as compared with net income of $48.6 million, or $0.32 per diluted share, in the same quarter of 2012. The increase in net income in the third quarter is primarily due to the 13 percent increase in royalty revenues. |
2013 Dividends
| |
• | On January 30, 2013, 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 2013 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively. On September 12, 2013, PDL paid the third quarterly dividend to stockholders of record totaling $21.0 million using earnings generated in the third quarter of 2013. |
Four Recent Transactions
Debt Financing Provided to Direct Flow Medical, Inc.
| |
• | On November 5, 2013, PDL entered into a debt financing transaction with Direct Flow Medical, Inc. (DFM), a transcatheter heart valve innovator focused on improving patient outcomes. PDL will provide a total of up to $50 million to DFM to be used to refinance its existing credit facility and fund the commercialization of its transcatheter aortic valve system used to treat aortic stenosis. An initial $35 million was provided at the close of the transaction, with the remaining $15 million to be funded upon the achievement of a specified revenue milestone. |
Debt Financing Provided to Durata Therapeutics, Inc.
| |
• | On October 31, 2013, PDL entered into a debt financing transaction with Durata Therapeutics, Inc. , a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. PDL will provide Durata with up to $70 million of debt financing to be used to refinance its existing credit facility and fund the commercialization of dalbavancin, an intravenous antibiotic product candidate, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI, caused by Gram-positive bacteria, such as S. aureus, including methicillin-resistant and multi-drug resistant strains, and certain streptococcal species. An initial $25 million was provided at the close of the transaction, with the remaining $45 million to be made available pending regulatory approval of dalbavancin. |
Acquisition of Diabetes Royalty Rights and Milestones from Depomed, Inc.
| |
• | On October 18, 2013, PDL acquired the rights to receive royalties and milestones payable on sales of Type 2 diabetes products licensed by Depomed in exchange for a $240.5 million cash payment. PDL will receive all royalty and milestone payments due under the agreements until it has received payments equal to two times the cash payment made to Depomed, after which all payments received will be shared evenly between PDL and Depomed. |
Debt Financing Provided to LENSAR, Inc.
| |
• | On October 1, 2013, PDL entered into a credit agreement with LENSAR, Inc., a leader in the development and commercialization of a more intelligent solution for refractive laser-assisted cataract surgery. PDL will provide LENSAR with up to $60 million of debt financing to be used to refinance its existing credit facility and fund the commercialization of its currently marketed LENSAR Laser System. An initial $40 million was provided at close of the transaction, with the remaining $20 million to be funded upon the attainment of a specified sales milestone. |
PDL BioPharma, Inc.
Q3-2013
November 6, 2013
Update on Litigation with Genentech/Roche
| |
• | PDL and Genentech/Roche have mutually agreed to stay the arbitration proceeding and to delay the time for responses in the Nevada litigation to allow time for discussions to determine if a settlement of certain issues is possible. The parties may not reach agreement regarding settlement terms and PDL expects that it will renew its litigation efforts if settlement is unsuccessful. PDL will have no further comment on this matter. |
Term-loan of $75 Million
On October 28, 2013, PDL entered into a credit agreement with Royal Bank of Canada and Wells Fargo Bank. The Credit Agreement consists of a term loan of $75,000,000, with a term of one year. PDL took advantage of an opportunity to borrow money at a very low cost of capital. The interest rates per annum applicable to amounts outstanding under the term loan are, at the Company’s option, either (a) the base rate (as defined in the Credit Agreement) plus 1.00%, or (b) the Eurodollar rate (as defined in the Credit Agreement) plus 2.00% per annum. Interest payments under the Credit Agreement are due on the interest payment dates specified in the Credit Agreement.
Updates on Approved Royalty Bearing Products
| |
• | On October 17, 2013, Genentech/Roche reported that YTD worldwide sales increased by 13%. |
| |
◦ | There was significant increase in sales in US in colorectal cancer due to label expansion through multiple lines of therapy. |
| |
◦ | Strong sales in EU were driven by ovarian and colorectal cancers with the latter due to the label expansion through multiple lines of therapy. |
| |
◦ | Steady growth in Japan in colorectal cancer, breast cancer and non-small cell lung cancer. |
| |
• | On July 25, 2013, Genentech/Roche stated that it intends to file for approval for treatment of cervical cancer in US and EU in 2014. |
| |
• | On December 12, 2012 and January 24, 2013, Genentech/Roche announced EU and US approval, respectively for second line metastatic colorectal cancer. |
|
|
Herceptin® (trastuzumab):
|
| |
• | On October 17, 2013, Genentech/Roche reported that YTD worldwide sales increased by 6%. |
| |
• | On September 2, 2013, Genentech/Roche said European Commission approved a subcutaneous formulation of Herceptin to treat HER2-positive breast cancer. |
| |
◦ | Subcutaneous administration takes 2-5 minutes instead of 30-90 minutes with the approved IV administration. |
| |
• | On October 17, 2013, Genentech/Roche reported that YTD US sales increased by 13%. |
| |
◦ | Less frequent than monthly dosing regimen is stabilizing market share in AMD. |
| |
◦ | Increasing share in RVO and DME markets. |
| |
• | On October 22, 2013, Novartis reported that 32Q13 ex-US sales were $581 million, down 1% from 3Q12. |
| |
• | On October 28, 2013, Biogen Idec reported that global sales in 3Q13 were $403 million, flat from a year ago. |
| |
• | On October 17, 2013, Genentech/Roche reported that YTD US sales increased by 12%. |
| |
• | On October 22, 2013, Novartis reported that 3Q13 ex-US sales were $151 million, up 13% from 3Q12. |
| |
• | On June 26, 2013, Novartis announced that the second Phase 3 trial in 335 patients ages 12-75 with moderate to severe refractory chronic idiopathic urticaria (CIU) treated with 300 mg subcutaneous Xolair given every 4 weeks for 24 weeks as an add-on to antihistamine therapy met the primary efficacy endpoint with a similar incidence and severity of adverse events between treated and placebo patients. |
| |
◦ | In February 2013, Novartis reported data from the first Phase 3 in 323 patients ages 12-75 with moderate to severe refractory CIU showing that 150 and 300 mg doses of Xolair as an add-on to antihistamine therapy each met the primary efficacy endpoint. |
| |
• | On July 17, 2013, Novartis disclosed that it had filed for EU approval for CIU. |
PDL BioPharma, Inc.
Q3-2013
November 6, 2013
| |
• | On October 10, 2013, Genentech/Roche announced that the FDA had accepted for filing the US approval application for CIU with a PDUFA date in second quarter of 2014. |
| |
• | On October 17, 2013, Genentech/Roche reported that YTD worldwide sales increased by 33%. |
| |
◦ | Sales growth was driven by monotherapy use with US being the biggest contributor to growth. |
| |
• | On October 21, 2013, Genentech/Roche announced approval of the subcutaneous formulation. |
| |
• | On April 30, 2013, Genentech/Roche announced that FDA had approved its use for the treatment of a rare, debilitating condition in children known as polyarticular juvenile idiopathic arthritis. |
| |
• | On October 17, 2013, Genentech/Roche reported YTD sales of CHF 186 million. |
| |
• | Genentech/Roche announced EMA approval in March 2013. |
| |
• | On September 30, 2013, Genentech/Roche announced that FDA had granted accelerated approval for the neo-adjuvant indication. |
|
|
Kadcyla™ (TDM-1 or ado-trastuzumab emtansine): |
| |
• | On October 17, 2013, Genentech/Roche reported YTD sales of CHF 156 million. |
| |
◦ | On February 22, 2013, Genentech/Roche announced that FDA approval for second line treatment of HER2+ metastatic breast cancer and first line treatment for patients who relapse within 6 months following adjuvant therapy. |
| |
• | On September 20, 2013, EU's Committee for Medicinal Products for Human Use recommended approval for the treatment of adults with HER2-positive, inoperable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. |
| |
• | Also on September 20, 2013, Japan approved it for the same indication. |
| |
• | On July 25, 2013, Genentech/Roche announced that a Phase 3 trial comparing Kadcyla to the physician's choice of treatment in patients with HER2-positive breast cancer who have already been treated with a HER2-targeted therapy, met its co-primary endpoint of progression free survival. The other endpoint is overall survival, but these data are not yet mature. |
|
|
Gazyva™ (Obinutuzumab or GA101): |
| |
• | On November 1, 2013, Genentech/Roche announced that Gazyva™ (obinutuzumab), formerly known as GA101, became the first therapy approved through the FDA’s breakthrough therapy designation, indicated in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL). Genentech/Roche expect Gazyva to be on the market in the United States by mid-November. |
| |
• | On May 15, 2013, Genentech/Roche announced approval applications for the treatment of chronic lymphocytic leukemia (CLL) had been submitted to regulatory authorities including the European Medicines Association (EMA) and the FDA. |
| |
◦ | Also announced, FDA designated it as a breakthrough therapy for CLL. |
| |
◦ | Previously, Genentech/Roche announced that results from Stage 1 of a Phase 3 trial showed CLL patients treated with obinutuzumab + chlorambucil had a progression free survival (PFS) of 23 months compared to 10.9 months for patients treated with chlorambucil only. |
| |
• | On July 2, 2013, Genentech/Roche announced FDA accepted their approval application and it had been granted priority review by FDA with a PDUFA date of December 20, 2013. |
| |
• | On July 23, 2013, Genentech/Roche announced that results from planned interim analysis of Stage 2 of same Phase 3 trial showed CLL patients treated with obinutuzumab + chlorambucil lived significantly longer without disease worsening (PFS) than patients receiving Rituxan + chlorambucil. |
| |
• | While the differences in PFS will not be disclosed until ASH in early December 2013, Genentech/Roche stated that the endpoint was achieved sooner than the target date of 2014 because of the magnitude of the difference between the two arms in Stage 2. |
PDL BioPharma, Inc.
Q3-2013
November 6, 2013
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. 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.
Q3-2013
November 6, 2013
|
| | | | | | | | | | |
Royalty Revenue by Product ($ in 000's) * |
Avastin | Q1 | Q2 | Q3 | Q4 | Total |
2013 | 33,234 |
| 46,720 |
| 32,224 |
| — |
| 112,177 |
|
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 |
2013 | 30,287 |
| 47,353 |
| 30,961 |
| — |
| 108,602 |
|
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 |
2013 | 12,032 |
| 30,066 |
| 13,536 |
| — |
| 55,633 |
|
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 |
2013 | 5,930 |
| 10,025 |
| 7,334 |
| — |
| 23,288 |
|
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 |
2013 | 340 |
| 1,414 |
| 748 |
| — |
| 2,502 |
|
2012 | — |
| — |
| 58 |
| 250 |
| 308 |
|
2011 | — |
| — |
| — |
| — |
| — |
|
2010 | — |
| — |
| — |
| — |
| — |
|
2009 | — |
| — |
| — |
| — |
| — |
|
2008 | — |
| — |
| — |
| — |
| — |
|
2007 | — |
| — |
| — |
| — |
| — |
|
2006 | — |
| — |
| — |
| — |
| — |
|
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total |
2013 | — |
| 551 |
| 830 |
| — |
| 1,381 |
|
2012 | — |
| — |
| — |
| — |
| — |
|
2011 | — |
| — |
| — |
| — |
| — |
|
2010 | — |
| — |
| — |
| — |
| — |
|
2009 | — |
| — |
| — |
| — |
| — |
|
2008 | — |
| — |
| — |
| — |
| — |
|
2007 | — |
| — |
| — |
| — |
| — |
|
2006 | — |
| — |
| — |
| — |
| — |
|
Tysabri | Q1 | Q2 | Q3 | Q4 | Total |
2013 | 12,965 |
| 13,616 |
| 11,622 |
| — |
| 38,203 |
|
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 |
2013 | 2,631 |
| 2,816 |
| 2,939 |
| — |
| 8,386 |
|
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 | — |
| — |
| — |
| — |
| — |
|
* As reported to PDL by its licensees | | |
Totals may not sum due to rounding | | |
PDL BioPharma, Inc.
Q3-2013
November 6, 2013
|
| | | | | | | | | | |
Reported Net Sales Revenue by Product ($ in 000's) * |
Avastin | Q1 | Q2 | Q3 | Q4 | Total |
2013 | 1,653,108 |
| 1,694,678 |
| 1,746,135 |
| — |
| 5,093,921 |
|
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 |
2013 | 1,681,574 |
| 1,744,145 |
| 1,681,860 |
| — |
| 5,107,579 |
|
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 |
2013 | 1,203,179 |
| 1,171,423 |
| 1,200,791 |
| — |
| 3,575,394 |
|
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 |
2013 | 341,309 |
| 365,778 |
| 391,900 |
| — |
| 1,098,987 |
|
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 |
2013 | 34,008 |
| 55,076 |
| 66,353 |
| — |
| 155,437 |
|
2012 | — |
| — |
| 5,080 |
| 25,000 |
| 30,079 |
|
2011 | — |
| — |
| — |
| — |
| — |
|
2010 | — |
| — |
| — |
| — |
| — |
|
2009 | — |
| — |
| — |
| — |
| — |
|
2008 | — |
| — |
| — |
| — |
| — |
|
2007 | — |
| — |
| — |
| — |
| — |
|
2006 | — |
| — |
| — |
| — |
| — |
|
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total |
2013 | — |
| 21,459 |
| 73,626 |
| — |
| 95,085 |
|
2012 | — |
| — |
| — |
| — |
| — |
|
2011 | — |
| — |
| — |
| — |
| — |
|
2010 | — |
| — |
| — |
| — |
| — |
|
2009 | — |
| — |
| — |
| — |
| — |
|
2008 | — |
| — |
| — |
| — |
| — |
|
2007 | — |
| — |
| — |
| — |
| — |
|
2006 | — |
| — |
| — |
| — |
| — |
|
Tysabri | Q1 | Q2 | Q3 | Q4 | Total |
2013 | 434,677 |
| 451,358 |
| 387,407 |
| — |
| 1,273,442 |
|
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 |
2013 | 87,703 |
| 91,374 |
| 97,961 |
| — |
| 277,038 |
|
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 |
|
2006 | — |
| — |
| — |
| — |
| — |
|
* 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 | | |
PDL BioPharma, Inc.
Q3-2013
November 6, 2013
|
| | | | | | | | | | | | |
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) * | | |
| | | | | | |
Avastin Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | 724,483 |
| 679,914 |
| 710,501 |
| 664,109 |
| 750,491 |
| 716,337 |
|
US Made & ex-US Sold | 532,979 |
| 428,976 |
| 281,905 |
| 161,369 |
| 165,651 |
| 360,177 |
|
ex-US Made & Sold | 316,265 |
| 442,437 |
| 670,572 |
| 827,629 |
| 778,536 |
| 669,621 |
|
Total | 1,573,727 |
| 1,551,327 |
| 1,662,977 |
| 1,653,108 |
| 1,694,678 |
| 1,746,135 |
|
US Made & Sold | 46 | % | 44 | % | 43 | % | 40 | % | 44 | % | 41 | % |
US Made & ex-US Sold | 34 | % | 28 | % | 17 | % | 10 | % | 10 | % | 21 | % |
ex-US Made & Sold | 20 | % | 29 | % | 40 | % | 50 | % | 46 | % | 38 | % |
| | | | | | |
Herceptin Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | 497,109 |
| 503,612 |
| 515,790 |
| 514,113 |
| 583,677 |
| 518,790 |
|
US Made & ex-US Sold | 466,477 |
| 545,625 |
| 552,127 |
| 486,400 |
| 563,243 |
| 522,159 |
|
ex-US Made & Sold | 661,727 |
| 614,459 |
| 582,578 |
| 681,060 |
| 597,225 |
| 640,911 |
|
Total | 1,625,313 |
| 1,663,695 |
| 1,650,495 |
| 1,681,574 |
| 1,744,145 |
| 1,681,860 |
|
US Made & Sold | 31 | % | 30 | % | 31 | % | 31 | % | 33 | % | 31 | % |
US Made & ex-US Sold | 29 | % | 33 | % | 33 | % | 29 | % | 32 | % | 31 | % |
ex-US Made & Sold | 41 | % | 37 | % | 35 | % | 41 | % | 34 | % | 38 | % |
| | | | | | |
Lucentis Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | 412,131 |
| 385,746 |
| 381,592 |
| 392,207 |
| 419,030 |
| 449,834 |
|
US Made & ex-US Sold | 674,411 |
| 711,795 |
| 728,103 |
| 810,972 |
| 752,393 |
| 750,958 |
|
ex-US Made & Sold | — |
| — |
| — |
| — |
| — |
| — |
|
Total | 1,086,543 |
| 1,097,541 |
| 1,109,695 |
| 1,203,179 |
| 1,171,423 |
| 1,200,791 |
|
US Made & Sold | 38 | % | 35 | % | 34 | % | 33 | % | 36 | % | 37 | % |
US Made & ex-US Sold | 62 | % | 65 | % | 66 | % | 67 | % | 64 | % | 63 | % |
ex-US Made & Sold | — | % | — | % | — | % | — | % | — | % | — | % |
| | | | | | |
Xolair Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | 193,600 |
| 211,702 |
| 210,892 |
| 207,976 |
| 218,860 |
| 236,180 |
|
US Made & ex-US Sold | — |
| — |
| — |
| — |
| — |
| — |
|
ex-US Made & Sold | 121,039 |
| 136,094 |
| 129,540 |
| 133,333 |
| 146,918 |
| 155,720 |
|
Total | 314,638 |
| 347,796 |
| 340,431 |
| 341,309 |
| 365,778 |
| 391,900 |
|
US Made & Sold | 62 | % | 61 | % | 62 | % | 61 | % | 60 | % | 60 | % |
US Made & ex-US Sold | — | % | — | % | — | % | — | % | — | % | — | % |
ex-US Made & Sold | 38 | % | 39 | % | 38 | % | 39 | % | 40 | % | 40 | % |
| | | | | | |
Perjeta Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | — |
| 5,080 |
| 24,571 |
| 32,377 |
| 48,979 |
| 49,111 |
|
US Made & ex-US Sold | — |
| — |
| 428 |
| 1,632 |
| 6,096 |
| 17,242 |
|
ex-US Made & Sold | — |
| — |
| — |
| — |
| — |
| — |
|
Total | — |
| 5,080 |
| 25,000 |
| 34,008 |
| 55,076 |
| 66,353 |
|
US Made & Sold | — | % | 100 | % | 98 | % | 95 | % | 89 | % | 74 | % |
US Made & ex-US Sold | — | % | — | % | 2 | % | 5 | % | 11 | % | 26 | % |
ex-US Made & Sold | — | % | — | % | — | % | — | % | — | % | — | % |
| | | | | | |
Kadcyla Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | — |
| — |
| — |
| — |
| 21,459 |
| 72,887 |
|
US Made & ex-US Sold | — |
| — |
| — |
| — |
| — |
| 739 |
|
ex-US Made & Sold | — |
| — |
| — |
| — |
| — |
| — |
|
Total | — |
| — |
| — |
| — |
| 21,459 |
| 73,626 |
|
US Made & Sold | — | % | — | % | — | % | — | % | 100 | % | 99 | % |
US Made & ex-US Sold | — | % | — | % | — | % | — | % | — | % | 1 | % |
ex-US Made & Sold | — | % | — | % | — | % | — | % | — | % | — | % |
| | | | | | |
Total Sales | 2012 - Q2 | 2012 - Q3 | 2012 - Q4 | 2013 - Q1 | 2013 - Q2 | 2013 - Q3 |
US Made & Sold | 1,827,323 |
| 1,786,053 |
| 1,843,345 |
| 1,810,783 |
| 2,042,496 |
| 2,043,139 |
|
US Made & ex-US Sold | 1,673,867 |
| 1,686,395 |
| 1,562,564 |
| 1,460,373 |
| 1,487,383 |
| 1,651,276 |
|
ex-US Made & Sold | 1,099,031 |
| 1,192,990 |
| 1,382,690 |
| 1,642,023 |
| 1,522,679 |
| 1,466,252 |
|
Total | 4,600,221 |
| 4,665,438 |
| 4,788,598 |
| 4,913,178 |
| 5,052,559 |
| 5,160,667 |
|
US Made & Sold | 40 | % | 38 | % | 38 | % | 37 | % | 40 | % | 40 | % |
US Made & ex-US Sold | 36 | % | 36 | % | 33 | % | 30 | % | 29 | % | 32 | % |
ex-US Made & Sold | 24 | % | 26 | % | 29 | % | 33 | % | 30 | % | 28 | % |
* 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 | | | | |