Following are some of the key points regarding PDL’s third quarter 2012 financial results and business activities.
- Net income for the third quarter of 2012 was $48.6 million, or $0.32 per diluted share, as compared with net income of $45.9 million, or $0.28 per diluted share, in the same quarter of 2011.
- In January 2012, we declared a regular, quarterly dividend of $0.15 per share of common stock payable on March 14, June 14, September 14 and December 14 to stockholders of record on March 7, June 7, September 7 and December 7.
- We paid $0.15 per share of common stock, or $21.0 million, on September 14, 2012, to our stockholders of record on September 7, 2012 as part of our regular, quarterly dividend policy for 2012.
Revenue Generating Assets
- PDL completed a transaction with Wellstat Diagnostics, LLC on November 2, 2012, in which PDL provided $40 million to Wellstat in return for interest and royalties on Wellstat’s diagnostic system.
- Wellstat was founded by Samuel J. Wohlstadter, the company’s chief executive officer who was also a founder of Amgen, Applied Biosystems, IGEN (a diagnostics system company that was acquired by Roche for approximately $1.4 billion), BioVeris (a diagnostics system company that was also acquired by Roche for approximately $600 million), and Hyperion Catalysis.
- Wellstat is developing a point of care diagnostic system that utilizes a disposable cartridge system, requires no user intervention, relies on standard blood collection techniques and can achieve results comparable to, or better than, central testing laboratories.
- PDL completed a transaction with AxoGen, Inc., on October 5, 2012, in which PDL provided $20.8 million to AxoGen in return for royalties on certain AxoGen products.
- AxoGen is a regenerative medicine company dedicated to advancing the science and commercialization of surgical solutions for peripheral nerve repair.
- These are PDL’s second and third publicly-announced transactions.
- On July 10, 2012, PDL entered into a credit agreement with Merus Labs International under which PDL made available up to $55 million to Merus secured by, among other things, its approved drug for overactive bladder.
- The final payment was made on our Non-Recourse Note during the third quarter of 2012. This $300 million securitization was entered into in November 2009 and most of the proceeds were paid to shareholders as a special dividend in December 2009. Approximately 60% of PDL’s Genentech/Roche royalties were obligated to repay this Note. We anticipate that our free cash flows will increase as a result of retiring this Note.
Current Conversion Rates of Convertible Notes
- PDL entered into a bond hedge that effectively increases the conversion price in the May 2015 Notes to $8.09.
Updates on Approved Royalty Bearing Products
- On October 31, 2012, Roche announced that the European Commission has approved Avastin in combination with standard chemotherapy (carboplatin and gemcitabine) as a treatment for women with first recurrence of platinum-sensitive ovarian cancer.
- On August 10, 2012, Genentech/Roche announced that a Phase 3 trial investigating Avastin plus radiation and chemotherapy in first line treatment of patients with newly diagnosed glioblastoma met its co-primary endpoint of a significant improvement in progression free survival.
- Data for final overall survival, the other co-primary endpoint, are expected in 2013.
- In its October 16, 2012, conference call with the financial community, Roche reported worldwide sales growth of 12% in the first three quarters of 2012.
- Based on data presented at the European Society of Medical Oncology, neither six month treatment nor two year treatment with Herceptin appears to confer patient benefit beyond the current standard of care of one year treatment.
- In its October 16, 2012, call with the financial community, Roche reported that Lucentis US market share declined by 8% in the first three quarters of 2012 with sales in AMD starting to stabilize.
- On August 10, 2012, FDA approved Lucentis for treatment of diabetic macular edema (DME).
- Genentech launched Lucentis for DME on August 15, 2012, with a price of $1,170 per 0.3 mg dose equal to the cost of the 0.5 mg dose of Lucentis, which is approved in the U.S. for macular edema secondary to retinal vein occlusion (RVO) and wet age-related macular degeneration (AMD).
- Lucentis is already approved for this indication in EU.
- On October 15, 2012, Genentech/Roche announced that the label had been expanded to include patients who had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
- In its October 16, 2012, call with the financial community, Roche reported worldwide sales growth of 34% in the first three quarters of 2012.
- On June 8, 2012, Genentech and Roche announced the U.S. Food and Drug Administration (FDA) approval of Perjeta in combination with Herceptin and docetaxel for the first line treatment of patients with HER2+ metastatic breast cancer.
- Price is $5,900 per month.
- Genentech and Roche have notified PDL of its status as a licensed product.
- PDL began receiving royalties in 3Q12 based on sales occuring in 2Q12.
- Royalties will be subject to the tiered system applicable to Avastin, Herceptin, Lucentis and Xolair sales.
- Genentech and Roche projected peak sales in excess of $1 billion annually for Perjeta.
- In its October 16, 2012, call with the financial community, Roche reported that Perjeta has a 31% new patient share in first line setting in US.
- In the adjuvant setting, Phase 2 data showed that patients on Perjeta, Herceptin and docetaxel had a pathologic complete response or pCR of 45.8% compared to 29% for those HER2+ breast cancer patients receiving only Herceptin and docetaxel.
- Perjeta is currently being studied in Phase 3 in the adjuvant setting.
Updates on Select Development Stage Potential Royalty Bearing Products
TDM-1 (trastuzumab emtansine):
- Genentech/Roche estimate annual peak sales in excess of $1 billion.
- On June 2, 2012, Roche/Genentech said that the Phase 3 trial of second line therapy in patients with metastatic HER2+ breast cancer comparing treatment with T-DM1 versus treatment with Tykerb and Xeloda showed:
- Significant improvement in PFS of 35% (9.6 months v. 6.4 months);
- One-year survival of 84.7% compared to 77.0%;
- Response rate of 43.6% compared to 30.8%; and
- Grade 3 or higher AE’s of 40.8% compared to 57.0%
- On August 27, 2012, Genentech/Roche announced that it had filed in US for approval as second line therapy in patients with metastatic HER2+ breast cancer.
- Roche said that it expects to make a similar filing in EU shortly.
- On October 1, 2012, Genentech/Roche announced that Phase 3 trial of T-DM1 as second line therapy in metastatic HER2+ breast cancer patients comparing treatment with T-DM1 versus treatment with Tykerb and Xeloda reduced the risk of death by 32%, meeting the trial’s coprimary endpoint.
- Both US Phase 3 trials in apoE4 and non-apoE4 carrier did not meet the primary co-endpoints of the trials.
- Further development in mild-to-moderate Alzheimer’s patients has been terminated.
- On August 24, 2012, Lilly announced that both of its Phase 3 trials did not meet the primary endpoints of cognitive and functional benefit.
- A pre-specified secondary subgroup analysis of the pooled data from both trials showed that solanezumab slowed the cognitive decline in patients with mild disease but not patients with moderate disease.
- On October 8, 2012, Lilly disclosed that the reduction in cognitive decline was 34% (p=.001) and there was a 17% reduction in functional decline as measured by ADCS-ADL that was not statistically significant (p=.057).
- On October 8, 2012, researchers at the Alzheimer’s Disease Cooperative Study reported that, based on their independent analysis of the data, there was a statistically significant reduction in cognitive decline as measured by ADAS Cog14 in the mild and moderate patients in the pooled data from both Phase 3 trials.
- Lilly said that it plans to discuss the data with regulatory authorities, and that its Phase 3 extension study is fully enrolled and on-going.
- If solanezumab were to receive marketing authorization, PDL would receive a patent royalty of 3% in addition to a 12.5 year know-how royalty of 2% from date of first sale.
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 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.
John P. McLaughlin
President and Chief Executive Officer
PDL BioPharma, Inc.