UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 8, 2013
PDL BioPharma, Inc.
(Exact name of Company as specified in its charter)
000-19756
(Commission File Number)
|
|
|
Delaware |
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94-3023969 |
(State or Other Jurisdiction of |
|
(I.R.S. Employer Identification No.) |
Incorporation) |
|
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932 Southwood Boulevard
Incline Village, Nevada 89451
(Address of principal executive offices, with zip code)
(775) 832-8500
(Company’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Company under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2013, PDL BioPharma, Inc. (the Company) issued a press release announcing the financial results for the second quarter ended June 30, 2013. A copy of this earnings release is attached hereto as Exhibit 99.1. The Company will host an earnings call and webcast on August 8, 2013, during which the Company will discuss its financial results for the second quarter ended June 30, 2013.
Item 7.01 Regulation FD Disclosure.
Presentation Materials
On August 8, 2013, the Company posted to its website a set of presentation materials that it will use during its earnings call and webcast to assist participants with understanding the Company’s financial results. A copy of this presentation is attached hereto at Exhibit 99.2
Information Sheet
On August 8, 2013, the Company distributed to analysts covering the Company’s securities a summary of certain information regarding the Company’s net income, dividends and licensed product development and sales (the Information Sheet) to assist those analysts in valuing the Company’s securities. The Information Sheet and its associated tables are attached hereto as Exhibit 99.3.
Limitation of Incorporation by Reference
In accordance with General Instruction B.2. of Form 8-K, the information in this report, including the exhibits, is furnished pursuant to Items 2.02 and 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
Cautionary Statements
This filing and its exhibits include “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. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Important factors that could impair the Company’s royalty assets or business are disclosed in the “Risk Factors” contained in the Company’s Annual Report on Form 10-K, as updated by subsequent quarterly reports, 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.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. |
Description | |
99.1 99.2 99.3 |
Press Release Presentation Information Sheet |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PDL BioPharma, inc. (Company) |
|||
By: | /s/ Peter S. Garcia | ||
Peter S. Garcia
Vice President and Chief Financial Officer |
|||
Dated: August 8, 2013
Exhibit Index
Exhibit No. |
Description | |
99.1 99.2 99.3 |
Press Release Presentation Information Sheet |
Exhibit 99.1
Contacts: |
|
Peter Garcia |
Jennifer Williams |
PDL BioPharma, Inc. |
Cook Williams Communications |
775-832-8500 |
360-668-3701 |
peter.garcia@pdl.com |
jennifer@cwcomm.org |
PDL BioPharma Announces Second Quarter 2013 Financial Results
INCLINE VILLAGE, NV, August 8, 2013 – PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the second quarter and six months ended June 30, 2013.
Royalty revenues for the second quarter of 2013 increased 14 percent to $143.6 million from $125.9 million reported in the second quarter of 2012. For the first six months of 2013, royalty revenues increased 16 percent to $235.5 million from $203.2 million reported in the comparable period of 2012.
Royalty revenues for the second quarter of 2013 are based on first quarter 2013 product sales by PDL’s licensees. The royalty revenue growth year to date is driven by increased sales by PDL’s licensees in the fourth quarter of 2012 and first quarter of 2013 of Avastin®, Herceptin®, Lucentis®, Perjeta®, Kadcyla®, Tysabri®, and Actemra®. Net sales of Avastin, Herceptin, Lucentis, Xolair, Perjeta, and Kadcyla are subject to a tiered royalty rate except in the case when the product is ex-U.S. Manufactured and Sold, in which case it is subject to a flat three percent royalty rate.
General and administrative expenses for the second quarter of 2013 were $6.8 million, compared with $5.1 million in the same quarter of 2012. For the six months ended June 30, 2013, general and administrative expenses were $14.0 million compared to $12.1 million in the comparable period of 2012. The increase in expenses for both the quarter and six months ended June 30, 2013, was a result of increased legal expenses related to litigation.
Net income for the second quarter of 2013 was $93.7 million, or $0.62 per diluted share, as compared with net income of $73.5 million, or $0.52 per diluted share, in the same quarter of 2012. The increase in net income in the second quarter is primarily due to the 14 percent increase in royalty revenues, and the release of a tax liability of $5.7 million which reduced the effective tax rate for the quarter. Net income for the first six months of 2013 was $147.2 million, or $0.96 per diluted share, as compared with net income of $113.7 million, or $0.80 per diluted share, in the same period of 2012.
Net cash provided by operating activities in the first six months of 2013 was $163.9 million, compared with $122.8 million for the first six months of 2012. At June 30, 2013, PDL had cash, cash equivalents and investments of $258.9 million, compared with $148.7 million at December 31, 2012. The increase was primarily attributable to net cash provided by operating activities of $163.9 million and repayment of notes receivable of $15.6 million, offset in part by payment of dividends of $42.0 million and cash advanced on the issuance of notes receivable of $27.3 million.
Recent Developments
Significant Additions to the PDL Team
PDL announced the addition of two key members to the Company’s finance team—Peter Garcia as vice president and chief financial officer and David Montez as controller and chief accounting officer. Mr. Garcia spent his previous 16 years in various CFO positions for biotechnology companies. He joins PDL from BioTime, Inc. (NYSE MKT: BTX) where he served as CFO since 2011. Mr. Montez, who is a licensed certified public accountant, brings more than 13 years of experience overseeing accounting and financial functions and most recently served as director of finance at GlassPoint Solar, Inc.
PDL also announced the addition of an external advisor, Glenn Reicin, who was retained by PDL to assist the company in acquiring income generating assets. He brings many years of experience in the medical device space, 15 years of which were spent as a ranked, medical device analyst at Morgan Stanley.
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 June 12, 2013, PDL paid the second quarterly dividend to stockholders of record totaling $21.0 million using earnings generated in the second quarter of 2013.
Revenue Guidance for 2013
As previously announced, PDL will continue to provide revenue guidance for each quarter in the third month of that quarter. Third quarter 2013 revenue guidance will be provided in September.
Conference Call Details
PDL will hold a conference call to discuss financial results at 4:30 p.m. ET today, August 8, 2013.
To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 25578899. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through August 14, 2013, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 25578899
To access the live and subsequently archived webcast of the conference call, go to the Company’s website at http://www.pdl.com and go to “Events & Presentations.” Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
About PDL BioPharma
PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases. Today, PDL is focused on intellectual property asset management, investing in new income generating assets and maximizing value for its shareholders. For more information, please visit www.pdl.com.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.
Forward-looking Statements
This press release 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 royalty bearing 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 and updated by subsequent Quarterly Reports on Form 10-Q. 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.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME DATA
(Unaudited)
(In thousands, except per share amounts)
Three Months Ended |
Six Months Ended |
||||||||||||||||
June 30, |
June 30, |
||||||||||||||||
2013 |
2012 |
2013 |
2012 |
||||||||||||||
Revenues |
|||||||||||||||||
Royalties |
$ | 143,617 | $ | 125,904 | $ | 235,464 |
# |
$ | 203,248 | ||||||||
Total revenues |
143,617 | 125,904 | 235,464 | 203,248 | |||||||||||||
Operating Expenses |
|||||||||||||||||
General and administrative expenses |
6,783 | 5,145 | 13,969 | 12,090 | |||||||||||||
Operating income |
136,834 | 120,759 | 221,495 | 191,158 | |||||||||||||
Non-operating expense, net |
|||||||||||||||||
Interest and other income, net |
4,963 | 428 | 8,801 |
# |
518 | ||||||||||||
Interest expense |
(6,051 | ) | (7,872 | ) | (12,051 | ) |
# |
(16,573 | ) | ||||||||
Total non-operating expense, net |
(1,088 | ) | (7,444 | ) | (3,250 | ) | (16,055 | ) | |||||||||
Income before income taxes |
135,746 | 113,315 | 218,245 | 175,103 | |||||||||||||
Income tax expense |
42,004 | 39,813 | 71,032 |
# |
61,417 | ||||||||||||
Net income |
$ | 93,742 | $ | 73,502 | $ | 147,213 | $ | 113,686 | |||||||||
Net income per share |
|||||||||||||||||
Basic |
$ | 0.67 | $ | 0.53 | $ | 1.05 |
# |
$ | 0.81 | ||||||||
Diluted |
$ | 0.62 | $ | 0.52 | $ | 0.96 |
# |
$ | 0.80 | ||||||||
Shares used to compute income per basic share |
139,825 | 139,683 | 139,821 | 139,681 | |||||||||||||
Shares used to compute income per diluted share |
152,224 | 142,213 | 152,784 | 142,890 | |||||||||||||
Cash dividends declared per common share |
$ | - | $ | - | $ | 0.60 | $ | 0.60 |
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In thousands)
June 30, |
December 31, |
|||||||
2013 |
2012 |
|||||||
Cash, cash equivalents and investments |
$ | 258,850 | $ | 148,689 | ||||
Total notes receivable |
$ | 110,633 | $ | 93,208 | ||||
Total assets |
$ | 401,424 | $ | 279,966 | ||||
Convertible notes payable |
$ | 315,320 | $ | 309,952 | ||||
Total stockholders' deficit |
$ | (1,261 | ) | $ | (68,122 | ) |
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW DATA
(Unaudited)
(In thousands)
Six Months Ended |
||||||||
June 30, |
||||||||
2013 |
2012 |
|||||||
Net income |
$ | 147,213 | $ | 113,686 | ||||
Adjustments to reconcile net income to net cash provided by operating activities |
6,145 | 12,779 | ||||||
Changes in assets and liabilities |
10,496 | (3,672 | ) | |||||
Net cash provided by operating activities |
$ | 163,854 | $ | 122,793 |
Three Months Ended |
Six Months Ended |
||||||||||||||||
June 30, |
June 30, |
||||||||||||||||
2013 |
2012 |
2013 |
2012 |
||||||||||||||
Avastin |
|||||||||||||||||
% Ex-U.S. Sold |
56 | % | 54 | % | 58 | % | 55 | % | |||||||||
% Ex-U.S.-based Manufactured and Sold |
46 | % | 20 | % | 48 | % | 23 | % | |||||||||
Herceptin |
|||||||||||||||||
% Ex-U.S. Sold |
67 | % | 69 | % | 68 | % | 70 | % | |||||||||
% Ex-U.S.-based Manufactured and Sold |
34 | % | 41 | % | 37 | % | 38 | % | |||||||||
Kadcyla |
|||||||||||||||||
% Ex-U.S. Sold |
0 | % | 0 | % | 0 | % | 0 | % | |||||||||
% Ex-U.S.-based Manufactured and Sold |
0 | % | 0 | % | 0 | % | 0 | % | |||||||||
Lucentis |
|||||||||||||||||
% Ex-U.S. Sold |
64 | % | 62 | % | 66 | % | 61 | % | |||||||||
% Ex-U.S.-based Manufactured and Sold |
0 | % | 0 | % | 0 | % | 0 | % | |||||||||
Perjeta |
|||||||||||||||||
% Ex-U.S. Sold |
11 | % | 0 | % | 9 | % | 0 | % | |||||||||
% Ex-U.S.-based Manufactured and Sold |
0 | % | 0 | % | 0 | % | 0 | % | |||||||||
Xolair |
|||||||||||||||||
% Ex-U.S. Sold |
40 | % | 38 | % | 40 | % | 39 | % | |||||||||
% Ex-U.S.-based Manufactured and Sold |
40 | % | 38 | % | 40 | % | 39 | % |
Exhibit 99.2
Exhibit 99.3
PDL BioPharma, Inc.
Q2-2013
August 8, 2013
Following are some of the key points regarding PDL’s second quarter 2013 financial and business results.
Net Income
● |
Net income for the second quarter of 2013 was $93.7 million, or $0.62 per diluted share, as compared with net income of $73.5 million, or $0.52 per diluted share, in the same quarter of 2012. The increase in net income in the second quarter is primarily due to the 14 percent increase in royalty revenues and the release of a tax liability of $5.7 million, which reduced the effective tax rate for the quarter. |
2013 Dividends
● |
On June 12, 2013, PDL paid its second quarterly dividend in 2013 to stockholders of record, totaling $21 million and using earnings generated in the second quarter of 2013. The Board of Directors previously declared two remaining dividends for 2013, each of $0.15 per share of common stock, payable on September 12 and December 12 of 2013 to all stockholders who own shares of PDL on September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively. |
Updates on Approved Royalty Bearing Products
Avastin® (bevacizumab):
● |
On July 25, 2013, Genentech/Roche reported that 1H13 worldwide sales increased by 12%. |
o |
There was significant increase in US sales in colorectal cancer due to label expansion through multiple lines of therapy. |
o |
Strong sales in EU were driven by ovarian and colorectal cancers, with the latter due to the label expansion through multiple lines of therapy. |
o |
In Japan, sales increase was driven by steady growth in non-small cell lung cancer. |
● |
Also 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 July 25, 2013, Genentech/Roche reported that 1H13 worldwide sales increased by 5%. |
● |
On June 28, 2013, Genentech/Roche said EMA’s CHMP issued a positive opinion recommending approval of a subcutaneous formulation of Herceptin to treat HER2-positive breast cancer. |
o |
Subcutaneous administration takes 2-5 minutes instead of 30-90 minutes with the approved IV administration. |
Lucentis® (ranibizumab):
● |
On July 25, 2013, Genentech/Roche reported that 1H13 US sales increased by 9%. |
o |
Less frequent than monthly dosing regimen is stabilizing market share in AMD. |
o |
RVO market share is stable and DME increased market share contributing to majority of Lucentis growth. |
● |
On July 17, 2013, Novartis reported that 2Q13 ex-US sales decreased by 3%. |
o |
Double digit volume growth offset by one-time price reductions required to secure reimbursement for new indications. |
o |
Eylea launched in key EU countries. |
● |
On July 5, 2013, Novartis announced that EU had expanded the label to include treatment for visual impairment due to choroidal neovascularization. |
o |
Lucentis is first therapy to be approved for this indication in EU. |
Xolair® (omalizumab)
● |
On July 25, 2013, Genentech/Roche reported that 1H13 US sales increased by 11%. |
● |
On July 17, 2013, Novartis reported that 2Q13 ex-US sales increased by 20%. |
● |
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. |
o |
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. |
o |
Genentech/Roche is expected to file for approval of this indication in 2H13. |
PDL BioPharma, Inc.
Q2-2013
August 8, 2013
Actemra® (tocilizumab):
● |
On July 25, 2013, Genentech/Roche reported that 1H13 worldwide sales increased by 33%. |
o |
Sales growth was driven by monotherapy use with US being the biggest contributor to growth. |
● |
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. |
Perjeta™ (pertuzumab):
● |
On July 25, 2013, Genentech/Roche reported 1H13 sales of CHF 108 million. |
● |
Genentech/Roche announced EMA approval in March 2013. |
● |
On July 1, 2013, Genentech/Roche announced that it had been granted priority review by FDA for use in neo-adjuvant setting for HER2+ breast cancer with PDUFA date of October 31, 2013. |
Kadcyla™ (TDM-1 or ado-trastuzumab emtansine):
● |
On July 25, 2013, Genentech/Roche reported 1H13 sales of CHF 83 million. |
● |
[Not Q2 but may be relevant to understand first bullet] 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. |
● |
Also 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. |
Updates on Select Development Stage Potential Royalty Bearing Products
Obinutuzumab:
● |
On May 15, 2013, Genentech/Roche announced Phase 3 data from the CLL11 study to be presented at ASCO for the treatment of chronic lymphocytic leukemia (CLL). |
o |
Announced marketing applications had been submitted to regulatory authorities including the European Medicines Association (EMA) and the FDA. |
o |
Also announced, FDA designated it as a breakthrough therapy for CLL. |
o |
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 that FDA accepted their Biologics License Application (BLA) 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. |
o |
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. |
Solanezumab:
● |
On July 12, 2013, Lilly announced details regarding its new Phase 3 trial. |
o |
2,100 patients with mild Alzheimer’s Disease with amyloid pathology confirmed by either PET or cerebrospinal fluid instead of 1,322 mild Alzheimer’s Disease patients in previous Phase 3s. |
o |
Co-primary endpoints of ADAS-Cog14 (cognition) and ADCS-iADL (function) instead of ADAS-Cog11 and ADCS-ADL used in previous Phase 3s. |
o |
22 months for patient enrollment beginning in September 2013 plus 18 month for patient follow up equals 40 months, or late 2016, to data. |
● |
If solanezumab were to receive marketing authorization, PDL would receive a patent royalty of 3% through the expiration of Queen et al. patents in addition to a 12.5 year know-how royalty of 2% from date of first sale. |
PDL BioPharma, Inc.
Q2-2013
August 8, 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.
Q2-2013
August 8, 2013
Royalty Revenue by Product ($ in 000's) *
Avastin |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
2013 |
33,234 |
46,720 |
- |
- |
79,953 |
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 |
- |
- |
77,640 |
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 |
2013 |
12,032 |
30,066 |
- |
- |
42,097 |
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 |
- |
- |
15,955 |
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 |
- |
- |
1,754 |
2012 |
- |
- |
58 |
250 |
308 |
2011 |
- |
- |
- |
- |
- |
2010 |
- |
- |
- |
- |
- |
2009 |
- |
- |
- |
- |
- |
2008 |
- |
- |
- |
- |
- |
2007 |
- |
- |
- |
- |
- |
2006 |
- |
- |
- |
- |
- |
Kadcyla |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
2013 |
- |
551 |
- |
- |
551 |
2012 |
- |
- |
- |
- |
- |
2011 |
- |
- |
- |
- |
- |
2010 |
- |
- |
- |
- |
- |
2009 |
- |
- |
- |
- |
- |
2008 |
- |
- |
- |
- |
- |
2007 |
- |
- |
- |
- |
- |
2006 |
- |
- |
- |
- |
- |
Tysabri |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
2013 |
12,965 |
13,616 |
- |
- |
26,581 |
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 |
- |
- |
5,447 |
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.
Q2-2013
August 8, 2013
Reported Net Sales Revenue by Product ($ in 000's) *
Avastin |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
2013 |
1,653,108 |
1,694,678 |
- |
- |
3,347,786 |
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 |
- |
- |
3,425,718 |
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 |
- |
- |
2,374,602 |
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 |
- |
- |
707,088 |
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 |
- |
- |
89,084 |
2012 |
- |
- |
5,080 |
25,000 |
30,079 |
2011 |
- |
- |
- |
- |
- |
2010 |
- |
- |
- |
- |
- |
2009 |
- |
- |
- |
- |
- |
2008 |
- |
- |
- |
- |
- |
2007 |
- |
- |
- |
- |
- |
2006 |
- |
- |
- |
- |
- |
Kadcyla |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
2013 |
- |
21,459 |
- |
- |
21,459 |
2012 |
- |
- |
- |
- |
- |
2011 |
- |
- |
- |
- |
- |
2010 |
- |
- |
- |
- |
- |
2009 |
- |
- |
- |
- |
- |
2008 |
- |
- |
- |
- |
- |
2007 |
- |
- |
- |
- |
- |
2006 |
- |
- |
- |
- |
- |
Tysabri |
Q1 |
Q2 |
Q3 |
Q4 |
Total |
2013 |
434,677 |
451,358 |
- |
- |
886,035 |
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 |
- |
- |
179,077 |
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 licensees | |||||
Totals may not sum due to rounding |
PDL BioPharma, Inc.
Q2-2013
August 8, 2013
Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
Avastin Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
652,824 |
724,483 |
679,914 |
710,501 |
664,109 |
750,491 |
US Made & ex-US Sold |
448,037 |
532,979 |
428,976 |
281,905 |
161,369 |
165,651 |
ex-US Made & Sold |
401,896 |
316,265 |
442,437 |
670,572 |
827,629 |
778,536 |
Total |
1,502,757 |
1,573,727 |
1,551,327 |
1,662,977 |
1,653,108 |
1,694,678 |
US Made & Sold |
43% |
46% |
44% |
43% |
40% |
44% |
US Made & ex-US Sold |
30% |
34% |
28% |
17% |
10% |
10% |
ex-US Made & Sold |
27% |
20% |
29% |
40% |
50% |
46% |
Herceptin Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
456,920 |
497,109 |
503,612 |
515,790 |
514,113 |
583,677 |
US Made & ex-US Sold |
523,353 |
466,477 |
545,625 |
552,127 |
486,400 |
563,243 |
ex-US Made & Sold |
534,982 |
661,727 |
614,459 |
582,578 |
681,060 |
597,225 |
Total |
1,515,255 |
1,625,313 |
1,663,695 |
1,650,495 |
1,681,574 |
1,744,145 |
US Made & Sold |
30% |
31% |
30% |
31% |
31% |
33% |
US Made & ex-US Sold |
35% |
29% |
33% |
33% |
29% |
32% |
ex-US Made & Sold |
35% |
41% |
37% |
35% |
41% |
34% |
Lucentis Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
433,428 |
412,131 |
385,746 |
381,592 |
392,207 |
419,030 |
US Made & ex-US Sold |
645,665 |
674,411 |
711,795 |
728,103 |
810,972 |
752,393 |
ex-US Made & Sold |
- |
- |
- |
- |
- |
- |
Total |
1,079,092 |
1,086,543 |
1,097,541 |
1,109,695 |
1,203,179 |
1,171,423 |
US Made & Sold |
40% |
38% |
35% |
34% |
33% |
36% |
US Made & ex-US Sold |
60% |
62% |
65% |
66% |
67% |
64% |
ex-US Made & Sold |
0% |
0% |
0% |
0% |
0% |
0% |
Xolair Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
185,505 |
193,600 |
211,702 |
210,892 |
207,976 |
218,860 |
US Made & ex-US Sold |
- |
- |
- |
- |
- |
- |
ex-US Made & Sold |
124,729 |
121,039 |
136,094 |
129,540 |
133,333 |
146,918 |
Total |
310,234 |
314,638 |
347,796 |
340,431 |
341,309 |
365,778 |
US Made & Sold |
60% |
62% |
61% |
62% |
61% |
60% |
US Made & ex-US Sold |
0% |
0% |
0% |
0% |
0% |
0% |
ex-US Made & Sold |
40% |
38% |
39% |
38% |
39% |
40% |
Perjeta Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
- |
- |
5,080 |
24,571 |
32,377 |
48,979 |
US Made & ex-US Sold |
- |
- |
- |
428 |
1,632 |
6,096 |
ex-US Made & Sold |
- |
- |
- |
- |
- |
- |
Total |
- |
- |
5,080 |
25,000 |
34,008 |
55,076 |
US Made & Sold |
0% |
0% |
100% |
98% |
95% |
89% |
US Made & ex-US Sold |
0% |
0% |
0% |
2% |
5% |
11% |
ex-US Made & Sold |
0% |
0% |
0% |
0% |
0% |
0% |
Kadcyla Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
- |
- |
- |
- |
- |
21,459 |
US Made & ex-US Sold |
- |
- |
- |
- |
- |
- |
ex-US Made & Sold |
- |
- |
- |
- |
- |
- |
Total |
- |
- |
- |
- |
- |
21,459 |
US Made & Sold |
0% |
0% |
0% |
0% |
0% |
100% |
US Made & ex-US Sold |
0% |
0% |
0% |
0% |
0% |
0% |
ex-US Made & Sold |
0% |
0% |
0% |
0% |
0% |
0% |
Total Sales |
2012 - Q1 |
2012 - Q2 |
2012 - Q3 |
2012 - Q4 |
2013 - Q1 |
2013 - Q2 |
US Made & Sold |
1,728,678 |
1,827,323 |
1,786,053 |
1,843,345 |
1,810,783 |
2,042,496 |
US Made & ex-US Sold |
1,617,054 |
1,673,867 |
1,686,395 |
1,562,564 |
1,460,373 |
1,487,383 |
ex-US Made & Sold |
1,061,607 |
1,099,031 |
1,192,990 |
1,382,690 |
1,642,023 |
1,522,679 |
Total |
4,407,339 |
4,600,221 |
4,665,438 |
4,788,598 |
4,913,178 |
5,052,559 |
US Made & Sold |
39% |
40% |
38% |
38% |
37% |
40% |
US Made & ex-US Sold |
37% |
36% |
36% |
33% |
30% |
29% |
ex-US Made & Sold |
24% |
24% |
26% |
29% |
33% |
30% |
* As reported to PDL by its licensees | ||||||
Totals may not sum due to rounding |
Page 6