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): March 9, 2010
PDL BioPharma, Inc.
(Exact name of Company as specified in its charter)
000-19756
(Commission File Number)
| Delaware | 94-3023969 | |
| (State or Other Jurisdiction of Incorporation) |
(I.R.S. Employer Identification No.) |
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 7.01 Regulation FD Disclosure.
On March 9, 2010, PDL BioPharma, Inc. (the “Company”) will make a presentation at the Cowen 30th Annual Health Care Conference in Boston. A copy of the Company’s presentation materials has been posted to the Company’s website and is attached hereto as Exhibit 99.1.
Limitation of Incorporation by Reference
In accordance with General Instruction B.2. of Form 8-K, the information in this report, including the exhibit, is furnished pursuant to Item 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. This Current Report will not be deemed an admission as to the materiality of any information in the report that is required to be disclosed solely by Regulation FD.
Cautionary Statements
This filing and the presentation 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 2009 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2010. 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.
(d) Exhibits.
| Exhibit |
Description | |||
| 99.1 | Presentation at the Cowen 30th Annual Health Care Conference on March 9, 2010 | |||
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/ CHRISTINE LARSON | |
| Christine Larson | ||
| Vice President and Chief Financial Officer | ||
Dated: March 9, 2010
EXHIBIT INDEX
| Exhibit |
Description | |||
| 99.1 | Presentation at the Cowen 30th Annual Health Care Conference on March 9, 2010 | |||
 Cowen 30 Annual Health Care Conference March 2010 Exhibit 99.1 th |
 Forward Looking Statements This presentation contains forward-looking statements, including PDL’s expectations with respect to its future royalty revenues, expenses, net income, and cash provided by operating activities. 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. Factors that may cause differences between current expectations and actual results include, but are not limited to, the following: • The expected rate of growth in royalty-bearing product sales by PDL’s existing licensees; • The relative mix of royalty-bearing Genentech products manufactured and sold outside
the U.S. versus manufactured or sold in the U.S.; • The ability of our licensees to receive regulatory approvals to market and launch new
royalty-bearing products and whether such products, if launched, will be
commercially successful; • Changes in any of the other assumptions on which PDL’s projected royalty revenues are based; • The outcome of pending litigation, interferences or disputes; and • The failure of licensees to comply with existing license agreements, including any
failure to pay royalties due. Other factors that may cause PDL’s actual results to differ materially from those expressed or implied in the forward- looking statements in this presentation are discussed in PDL’s filings with the SEC, including the "Risk Factors" sections of its annual and quarterly reports filed with the SEC. Copies of PDL’s filings with the SEC may be obtained at the "Investors" updates or revisions to any forward-looking statements contained herein to reflect any change in PDL’s expectations with regard thereto or any change in events, conditions or circumstances on which any such
statements are based for any reason, except as required by law, even as new
information becomes available or other events occur in the future. All forward-looking statements in this presentation are qualified in their entirety by
this cautionary statement. 2 section of PDL’s website at www.pdl.com. PDL expressly disclaims any obligation or undertaking to release publicly any |
 Agenda • Overview of PDL BioPharma • Royalty revenue & licensed products • Optimizing stockholder return 3 |
 Overview of PDL BioPharma 4 |
 Company Background • PDL pioneered the humanization of monoclonal antibodies which enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases • PDL’s primary assets are its antibody humanization patents and royalty assets which consist of its Queen et al. patents and license agreements • Licensees consist of large biotechnology and pharmaceutical companies including Roche/Genentech, Elan/BiogenIDEC, Wyeth and Chugai 5 |
 Mission • Manage patent portfolio • Manage license agreements • Optimize return for shareholders 6 |
 2009
Performance 7 We do not invest in R&D or in operating companies • PDL is a highly profitable company with revenue in 2009 in of $318 million and fewer than 10 employees • PDL is domiciled in Nevada where there is no state corporate income tax • PDL’s mission is to improve shareholder return We paid three dividends of $0.50/share in April, $0.50/share in October and $1.67/share in December totaling $2.67 in 2009 Our goal is to pay dividends annually & have declared two dividends of $0.50 each/share in 2010 We signed one new license under the Queen et al. patents in 2009 and are seeking new licenses in 2010 |
 Legal
Matters • Genentech Settlement agreement resolved all disputes regarding infringement of the Genentech
products and the validity and enforceability of our patents Multiple product licenses with tiered royalty structure • Alexion Settlement in December 2008 stipulated infringement, validity and enforceability of
PDL patents and no future contest of PDL patents License for Soliris in exchange for $25 million and option for four additional licenses at 4% royalty • MedImmune In 2008, MEDI initiated litigation seeking declaratory judgment of patent invalidity and non-infringement and a lower royalty rate based on its “most
favored licensee” (MFL) rights - PDL believes that it has no obligation to offer a lower royalty rate to MEDI under the MFL clause PDL is suing MEDI for patent infringement because PDL has cancelled the MEDI
license agreement due to MEDI’s failure to pay all royalties due and blockage of PDL’s exercise of its contractual rights • UCB/Celltech US Patent Office has declared two interference proceedings between certain claims of
Queen et al. patents and pending claims of Adair et al. UCB/Celltech is the assignee of the Adair et al. patent 8 |
 Converts and Securitization Note • $200 million 2.75% convertible subordinated notes due August 2023 Conversion rate is 164.7254 shares per $1,000 face amount ($6.07/share)
Holders have a put right in August 2010, August 2013, and August 2018 - August 2010 put can be for cash or stock, at noteholder’s discretion - Subsequent puts are cash or stock at PDL’s discretion Price as of March 3rd was ~118 vs. stock price of $7.00 • $228 million 2.00% convertible senior notes due February 2012 Conversion rate is 119.294 shares per $1,000 face amount ($8.38/share) Price as of March 3rd was ~96 vs. stock price of $7.00 • $300 million 10.25% note with expected maturity of December 2012 Securitized by 60% of 5-year NPV of Genentech royalties Anticipated final maturity is December 2012; legal maturity is March 2015 After final maturity securitized Genentech royalties return to PDL Distributed $200 million as special dividend of $1.67/share in December 2009 9 |
 Corporate Governance Management • John McLaughlin President & CEO • Christine Larson VP & CFO • Christopher Stone VP, General Counsel & Secretary • Karen Wilson VP of Finance Board of Directors • Fred Frank Lead Director • Joseph Klein • Jody Lindell • John McLaughlin • Paul Sandman • Harold Selick 10 |
 Royalty Revenue &
Licensed Products 11 |
 Royalty Revenue & Licensed Products PDL Royalties by Product ($ in millions) 12 $100 $150 $200 $250 $300 $350 Herceptin Avastin Lucentis Synagis Tysabri Other 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 $0 $50 |
 Royalties: When Licensed Product is Made or Sold • PDL’s revenues consist of royalties generated on sales of licensed products Sold before the expiration of the Queen et al. patents in 2013/14 or Made prior to the expiration of the Queen et al. patents and sold anytime
thereafter 13 Example of Antibody Formulation, Fill and Finish Schedule ½ month 1 month ½ month 2-3 months Thaw, Formulation & Vial Filling Quality Release Packaging & Quality Inventory Example of Antibody Bulk Manufacturing Schedule Cell Culture Quality Release Testing Bulk Frozen Storage 1 mo 3 mos 5 mos 10 mos 15 mos 20 mos 27 mos Purification to Concentrated Bulk/Frozen 3 mos 2-18 months 1mo 1mo |
 Product Made in US Net Sales up to $1.5 Billion 3.0% Net Sales Between $1.5 Billion and $2.5 Billion 2.5% Net Sales Between $2.5 Billion and $4.0 Billion 2.0% Net Sales Over $4.0 Billion 1.0% Product Made and Sold Ex-US All Sales 3.0% Genentech/Roche Royalties • In 2009, only 12% of Genentech/Roche sales was ex-US manufactured and sold product • Average royalty rate on all Genentech/Roche products under Genentech license was 1.14% 14 |
 Genentech/Roche—Future Manufacturing • Roche has begun to move some manufacturing ex-US Two new plants in Singapore More production at Penzburg, Germany plant • Roche says it will complete global
restructuring of manufacturing in 2010 15 |
 Select Licensed Products 16 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Lucentis Approved Phase 3 AMD RVO DME Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes |
 Select Licensed Products 17 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Ela Roc Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On November 16, 2009, Roche filed two sBLAs with FDA for treatment of women who have not received chemotherapy for metastatic HER2-negative breast cancer (first-line treatment) One sBLA is for use of Avastin in combination with docetaxel chemotherapy Second sBLA is for Avastin in combination with a taxanes. On November 24, 2009, Roche made similar filings in Europe. Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer |
 Select Licensed Products 18 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On December 11, 2009, Roche announced results from a Phase 3 study (RIBBON 2) in
women who had previously been treated with initial (first-line) chemotherapy
for advanced HER2-negative breast cancer and needed additional
(second-line) treatment The study showed that women who received Avastin in combination with a commonly used chemotherapy had a 28% improvement in the likelihood of living without the disease
getting worse, compared with those who received chemotherapy alone (hazard
ratio=0.78; p=0.0072) |
 Select Licensed Products 19 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On February 24, 2010, Roche announce that Phase 3 study showed the combination of
Avastin and chemotherapy followed by maintenance use of Avastin alone increased the time women with previously untreated advanced ovarian cancer lived without the disease
worsening (progression-free survival), compared to chemotherapy
|
 Select Licensed Products 20 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On February 22, 2010, Roche announced that Phase 3 study (AVAGAST) did not meet its
primary endpoint of showing Avastin plus Xeloda or 5-FU and cisplatin chemotherapy extended the lives of people with inoperable or advanced stomach (gastric) cancer, compared to chemotherapy alone |
 Select Licensed
Products 21 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On January 28, 2010, Roche announced EU approval for the use of Herceptin first line treatment of HER-2 positive stomach or gastro-esophageal junction cancers
|
 Select Licensed Products 22 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes Ela Ro Wy Ela Lilly Additional data from on-going Phase 3 trial in over 3,000 early stage breast cancer patient
showed one year treatment with Herceptin plus one of several commonly used chemotherapeutics reduced the risk of recurrence by 36% and risk of death by 37% compared to chemotherapy alone - at least 80% of the women who received one year treatment with Herceptin were cancer free at five years Additional data from on-going open label Phase 3 trial in 3,400 early stage breast cancer patients showed disease free survival rates at five years of 80% and 84% (depending on whether Herceptin treatment was sequential or concurrent with chemotherapy, respectively) compared to 72% for chemotherapy alone |
 Select Licensed Products 23 Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes Licensee Product Status Indications Roche announced results from a Phase 2 study of T-DM1 showing that it shrank the
tumors in 33% of women with HER2+ breast cancer that had worsened following
previous treatment. In this single-arm study of over 100 patients; 45%
of women experienced a clinical benefit. This is significant because the
women had essentially exhausted all other medical options Roche has said that it expects to discuss this data with the FDA to ascertain whether it can file a BLA for third line treatment in 2010 For second line treatment, patient enrollment is on track in the Phase 3 trial For first line treatment, patient enrollment has been completed in a Phase 2 with
interim data expected this year, and a first line Phase 3 trial is targeted
to begin mid-2010 Ela Ro Wy Ela Lill |
 Licensee Product Status Indications Roche (Genentech) Avastin Approved Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Lucentis Approved Phase 3 AMD RVO DME Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes Select Licensed Products 24 On December 22, 2009, Genentech announced that it had submitted a sBLA to the FDA for treatment of patients with macular edema following retinal vein occlusion (RVO) Assuming a 10-month standard review, PDUFA date would fall on October 22, 2010
|
 Select Licensed Products 25 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings DME Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On November 18, the FDA Advisory Committee on Pulmonary-Allergy Drugs Advisory
Committee did not support approval of the sBLA to expand the label from adults to include children 6 to <12 years old with moderate to severe persistent asthma
|
 Select Licensed Products 26 Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Lucentis Approved AMD Xolair Approved sBLA Moderate-Severe Asthma Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes FDA and EMEA changed the labeling to reflect risk of PML increased with duration of treatment Licensee Product Status Indications |
 Select Licensed
Products 27 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer sBLA Pediatric Asthma Elan Tysabri Approved Multiple Sclerosis Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On January 8, 2010, Genentech announced US approval for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor antagonists Actemra was already approved for this indication in the EU |
 Select Licensed Products 28 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Herceptin Approved Breast HER2+ Cancer HER2+ stomach and gastro-esophageal Cancers trastuzumab-DM1 Phase 2 and 3 Breast HER2+ Cancer Ela Roche/Chugai Actemra Approved Rheumatoid Arthritis Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On February 26, results from a Phase 2 study of 28 patients with Alzheimer’s disease were
reported on Lancet Neurology which showed 9 percent reduction in amyloid-beta deposits
on the brain from a baseline in treated patients compared to a plaque increase of 15
percent in placebo patients Amyloid-beta deposits were measured using a neuroimaging technique known as PiB PET
|
 Select Licensed
Products 29 Licensee Product Status Indications Roche (Genentech) Avastin Approved Phase 3 Colorectal Cancer NSCLC Metastatic Breast Cancer Glioblastoma Metastatic Renal Cell Ovarian Cancer Gastric Prostate Cancer Adjuvant settings Elan Roc Wyeth Mylotarg Approved Acute Myeloid Leukemia Elan/J&J/Pfizer Bapineuzumab Phase 3 Alzheimer’s Disease Lilly Solanezumab Phase 3 Alzheimer’s Disease Teplizumab Phase 3 Newly Diagnosed Type 1 Diabetes On December 21, 2009, PDL and Lilly entered into a non-exclusive license with respect to
teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next generation anti-CD3 molecules Teplizumab is currently being studied by Lilly and its partner MacroGenics for the treatment of individuals with newly-diagnosed type 1 diabetes mellitus In June 2009, the pivotal Phase 2/3 reached its targeted enrollment Also in June 2009, a Phase 3 global study was initiated and is designed to capture patient- reported outcome measures in addition to safety and efficacy data |
 Genentech/Roche—Future Products • In December 2008, Genentech exercised options for four additional antigens and extended other options paying fees totaling $1.8 million • Genentech can seek to convert the exercised options into license agreements by identifying the target antigen and so long as certain other conditions are met • Genentech/Roche has a number of humanized antibodies in Phase 3 Pertuzumab HER2+ breast cancer- Phase 3 started in 1Q08 GA101 CLL, NHL – Phase 3 started in Q409 Orcrelizumab RA – Positive Phase 3 in 4Q09, methotrexate naive and TNF inadequate responders in 2010 but Roche/BIIB announced on Monday suspension of RA trials based on safety concerns raised by DSMB 30 |
 Genentech / Roche
– US & EU Filings 31 2009 2010 2011 2012 Avastin + docetaxel mBC 1L (US) Avastin mBC 2L Avastin Recurrent ovarian ca platinum sensitive Avastin BC adj HER2- Avastin +STD chemo mBC 1L Avastin CC adj Avastin Prostrate ca Herceptin SC formulation (EU) Herceptin Gastric ca HER+ (EU) Avastin Ovarian ca 1L Avastin + Herceptin mBC HER2+ 1L GA 101 1 CLL Lucentis Retinal vein occlusion (US) Herceptin Gastric ca HER2+ (US) Pertuzumab 1 mBC HER2+ T-DM1 mBC HER2+ 2L T-DM1 mBC HER2+ 3L (US) Lucentis Diabetic macular edema (US) Avastin Herceptin Lucentis T-DM1 Pertuzumab 1 GA-101 1 1. Not a licensed product |
 Optimizing Stockholder Return 32 |
 Optimizing Stockholder Return • Intend to distribute royalty revenues, net of operating expenses, debt service and income taxes Will pay special dividend of $0.50 per share on April 1, 2010 to holders of record on March 15, 2010 Will pay second special dividend of $0.50 per share on October 1, 2010 to holders of record on September 15, 2010 • Continuously evaluating alternatives Purchase of commercial stage, royalty generating assets Convertible note buyback or share repurchase Company sale Do not expect to securitize any additional assets in 2010 33 |
 High
Dividend Yield with Upside Optionality • Inventory on hand at Queen patent et al. expiry 12/2014 • Change in manufacturing US / ex-US mix for Roche/Genentech resulting in higher average royalty rates • New Phase 2/3 indications with existing commercial products • New Phase 2/3 pipeline products: Solanezumab (Alzheimer’s disease) Bapineuzumab (Alzheimer’s disease) Teplizumab (newly diagnosed Type 1 Diabetes) • Genentech exercised 4 options in December 2008 34 |
 Investment Rationale • Strong revenue growth from approved products • Potential for additional indications from existing products and new product approvals • Significantly reduced expenses with no R&D burn • Liquidity—Volume averages 2 to 3 million share per day • Return to stockholders Declared three special cash dividends totaling $2.67/share in 2009 Will pay two special cash dividends totaling $1.00/share in 2010 35 |