April 1, 2014 Tuesday

Transcription

1 $ Millions April 1, 2014 Tuesday Today s Intelligence at a Glance 1. Incyte: Proof of Mechanism Data for IDO Inhibitors Expected This Year, Could Provide Insights on Future Positioning of INCB24360 JMP Securities/Bayko, April 1, 2014 Indication: Hematologic 2. Incyte: Jakafi's WAC Raised 4.8%; Price Increase Should Help Jakafi to Continue to Meet or Exceed Expectations Cowen and Company/Schmidt, April 1, 2014 Indication: Multiple 3. Lilly: Alimta Forecasts Raised as Court Ruled in Favor of Its 209 Patent, Exclusivity Extends to 2022; Modest Erosion Expected Due to Competitive Pressures from the PD-1s JPMorgan/Schott, March 31, 2014 Indication: Multiple 4. Pfizer: Palbociclib s Approval May Be Possible If Final Phase II Data Shows Similar PFS as Interim and Some OS Benefit; Novartis LEE011 Roughly One-Year Behind Morgan Stanley/Risinger, March 31, 2014 Indication: Breast 5. Active Biotech: TASQ in Pre-Chemo mcrpc Could Be a $1.4B WW Opportunity Based on 2nd/3rd-Line Use; Positive Phase III Results Expected Goldman Sachs/Fung, March 31, 2014 Indication: Prostate 6. Myriad Genetics: Survey Shows Physicians are More Than Willing to Convert Away from BRACAnalysis; Competition Expected to Have Significant Impact on Pricing and Share JPMorgan/Peterson, March 31, 2014 Indication: Multiple 7. GlaxoSmithKline: More RCC Patients Prefer Continuing Treatment with Votrient Than Sutent in a Phase III Preference Study Press Release, April 1, 2014 Indication: Kidney 8. Celgene: Expands Collaboration with Forma for Up to $600M, with a Possible Buyout; Will Evaluate Emerging Families of Targets for New Drugs Genetic Engineering & Biotechnology News, April 1, 2014 Indication: Ovarian $1,400 $1,200 $1,000 Additional Analysis $800 $600 $400 $200 $0 355 Sources: Company Reports; 5+ Brokerage Analyst Reports Study Name Estimated Design Indication Endpts Completion Date NCT Myelofibrosis 1º: Proportion of June 2015 COMFORT-I subjects achieving 35% reduction in spleen volume; 2º: Duration of maintenance, OS Has Results NCT Myelofibrosis 1º: Proportion of February 2015 COMFORT-II subjects achieving 35% reduction in spleen volume; 2º: Duration of maintenance, PFS, LFS, OS, Histomorphology Has Results NCT PV 1º: Proportion of March 2014 RESPONSE; vs. Best Available Care (Resistant to or Intolerant of Hydroxyurea) subjects achieving a response at Week 32; 2º: Proportion of subjects achieving complete hematologic remission at Week 32 Ongoing NCT PV 1º: Proportion of November 2013 The Relief Study (Switch Study From Hydroxyurea to Ruxolitinib) LFS: Leukemia Free Survival PFS: Progression-Free Survival PV: Polycythemia Vera OS: Overall Survival Incyte - Annual Revenues Forecast Phase III Trials for Jakafi 968 subjects with 50% reduction in a cluster of PV-related symptoms; 2º: Proportion of subjects with 50% reduction in individual PV-related symptoms at Week 16, Duration of symptomatic improvement 1, A 2014E 2015E 2016E 2017E Recruiting Source:

2 Incyte: Proof of Mechanism Data for IDO Inhibitors Expected This Year, Could Provide Insights on Future Positioning of INCB24360 This year, we expect proof of mechanism data for indoleamine 2,3 dioxygenase (IDO) inhibitors - an immunotherapy in development for a wide range of cancers. We look to data at ASCO in June from Incyte's IDO inhibitor INCB24360 ('360) to show enhancement of response rates in combination with Bristol's (BMY) ipilimumab as the first proof of principal, and believe it represents the next inflection point in shares of Incyte. Inhibitors from Incyte and NewLink Genetics are the most advanced in the class, in our view. With the potential to augment many forms of immunotherapy, we see the market potential in the multi-billions range. IDO inhibitors in development. Incyte's '360 is a selective IDO inhibitor. The compound has shown IDO inhibition in vitro and in humans as measured by an ex-vivo assay of IDO inhibition. A Phase 1 study demonstrated a dose response that maxes out IDO inhibition at >300mg of IDO dosed BID. The compound has also been shown in animal models to improve T cell proliferation, decrease Kyn levels and decrease production of Tregs. '360 demonstrates synergistic activity in vitro with other checkpoint inhibitors including BMY's CTLA4 inhibitor or PD-1 inhibitors - data that has catalyzed partnerships between Incyte and BMY and Merck & Co. (MRK). Collaborations and future positioning of '360. Our conversations with management suggest that once Incyte receives data from combinations with ipilimumab and MRK's PD-1 inhibitor, the path forward for '360 will be clearer. Incyte believes '360 may boost activity of checkpoint inhibitors in indications where the compounds are marginal as single agents, such as in solid tumors like prostate. The development plan will be data driven to move '360 into areas where it can bring the most value in combination. Source: JMP Securities/Bayko, April 1, 2014 Oncology Indication: Multiple Keyword: Clinical Trials/Pipeline

3 Incyte: Jakafi's WAC Raised 4.8%; Price Increase Should Help Jakafi to Continue to Meet or Exceed Expectations Third party sources indicate that as of March 28 th, Incyte has increased the price of Jakafi by 4.8%. Jakafi's WAC is now approximately $105K/year. Jakafi's price was previously increased 9.5% and 9% in August 2013 and November Historically, management has been able to capture nearly all of the previous Jakafi price increases. Our Jakafi U.S. revenue model assumes average price increases of 3% per annum. Hence, today's news suggests that pricing could support upside to our estimates. We continue to view Jakafi as a drug with striking efficacy in MF, PV, and potentially other cancers and limited near-term competition. In addition, Incyte has multiple promising early (an IDO-inhibitor INCB24360, c-met inhibitor INCB28060, and a PI3K inhibitor INCB40093) and mid-stage (INCB39110; JAK1 inhibitor) oncology programs as well as baricitinib a Phase III rheumatoid arthritis (PII for psoriasis and diabetic nephropathy) compound partnered with Lilly. As a result, we believe Incyte possesses one of the premier pipelines in mid-cap biotech. Source: Cowen and Company/Schmidt, April 1, 2014 Oncology Indication: Hematologic Keyword: Pricings/Generics

4 Lilly: Alimta Forecasts Raised as Court Ruled in Favor of Its 209 Patent, Exclusivity Extends to 2022; Modest Erosion Expected Due to Competitive Pressures from the PD-1s Lilly announced that U.S. District Court for the Southern District of Indiana ruled in favor of Lilly on the '209 Alimta patent (dosing with vitamin B12 and folic acid) which extends out until While there had been some expectation that Lilly would prevail in the case, we nonetheless view today s ruling as an incremental positive for the company. We are raising our Alimta forecasts which had previously reflected the product going generic in We are raising our longer-term US Alimta forecasts to reflect exclusivity in the US through the 209 patent expiration. We had previously forecast the product going generic in the US following the expiration of the compound patent in We now expect Alimta to reach a peak of $3 billion WW sales in 2017, with modest erosion due to competitive pressures from the PD-1s toward the end of the decade. Source: JPMorgan/Schott, March 31, 2014 Oncology Indication: Multiple Keyword: Sales/Rx Trends

5 Pfizer: Palbociclib s Approval May Be Possible If Final Phase II Data Shows Similar PFS as Interim and Some OS Benefit; Novartis LEE011 Roughly One-Year Behind Expert views Pfizer s palbociclib (palbo) interim Phase 2 data as extremely compelling. He called the improvement in progression-free survival (PFS 26.1 months vs. 7.5 months, HR 0.37) unprecedented. He does not expect a benefit in overall survival (OS) because OS benefit is generally difficult to show in first-line breast cancer and the trial was very small (N~160). He is not concerned about the high rates of low white blood cell count (both neutropenia and leukopenia) because no increased rates of infection were reported. He discounts the chance of FDA approval based on Phase 2 data only, and believes that it may be possible only if the final PFS is similar to the interim plus palbo shows some OS benefit. His reasoning is based on inaparib (PARP inhibitor) that showed a significant PFS and OS benefit in Phase 2 triple-negative breast cancer but failed in Phase 3. We model palbo launch in 2016; we await data on Apr. 6 plus management updates on filing discussions with FDA. He thinks Phase 3 metastatic breast cancer trials could report some data in Pfizer is running two Phase 3 trials in metastatic ER+ breast cancer first-line (PALOMA-2) and prior endocrine failures (PALOMA-3). There is also a trial in high-risk adjuvant (PENELOPE-B), but adjuvant trials generally run for several years. He believes that Novartis LEE011 (CDK 4/6) is roughly one year behind and would have a very similar profile to palbo. His experience is that drugs with similar mechanisms generally are more similar than not. He also mentioned that Novartis Afinitor (mtor inhibitor), which is approved in combo with Aromasin for endocrine-failure ER+ breast cancer, has an arguably worse side effect profile than palbo because Afinitor s side effects are symptomatic whereas neutropenia is not (as long as there are no infections). Source: Morgan Stanley/Risinger, March 31, 2014 Oncology Indication: Breast Keyword: Clinical Trials/Pipeline

6 Active Biotech: TASQ in Pre-Chemo mcrpc Could Be a $1.4B WW Opportunity Based on 2 nd /3 rd -Line Use; Positive Phase III Results Expected TASQ represents a mid-sized commercial opportunity (after ex-eu and Asia out-licensing) with a unique mechanism of action. However, we note that it also has low barriers to entry (oral compound with risk of generic competition after loss of exclusivity in 2024) and is a high risk opportunity given its mechanism of action is unproven. This compares to lead assets that are biologics with high barriers to entry for other European Biotech companies. Active Biotech has several other assets in its pipeline, including Nerventra (oral drug filed for multiple sclerosis in Europe), ANYARA (fusion protein that activates the immune system to attack cancer cells, Phase III development for renal cancer), RhuDex (oral immunomodulator, Phase II for primary biliary cirrhosis by partner, MediGene), ISI (platform technology). We believe that the near-term focus of Active Biotech will be the outcome of the TASQ Phase III trial in prostate cancer (10TASQ10). We expect a positive trial outcome, based on solid PFS activity in the Phase II study (ITT HR=0.57, p=0.0042). We see TASQ pre-chemo mcrpc as a $1.4 bn worldwide opportunity (company-compiled consensus of $800 mn), based on use in second/third-line use (after Xtandi/Zytiga and before chemo treatment). We estimate it receives peak risk-adjusted royalties of Skr1.1 bn. TASQ is also in Phase II development for solid tumors (data end-2014). Albeit early stage, positive data in one or more tumor types unlocks a potential $1.5 bn opportunity. It has another asset, Nerventra (partnered with Teva) for multiple sclerosis. Following a negative European regulatory decision in Jan-2014, we believe expectations have been rebased for a 2016 refiling. A positive appeals decision (mid-2014) represents upside to our base case. Source: Goldman Sachs/Fung, March 31, 2014 Oncology Indication: Prostate Keyword: Clinical Trials/Pipeline

7 Myriad Genetics: Survey Shows Physicians are More Than Willing to Convert Away from BRACAnalysis; Competition Expected to Have Significant Impact on Pricing and Share BRCA headwinds will be hard to overcome. The primary longer-term risks for Myriad, in our opinion, remain increased competition and pricing pressure within the legacy BRCA business, while there remains significant uncertainty around the outlook for myrisk. While Myriad has taken steps to diversify, we do not see a clear means to overcome the significant BRCA headwind over the coming months. Physician survey highlights numerous near-term challenges. With competition increasing, we recently surveyed physicians (n=28), including both oncologists and ob/gyns, to better understand the BRCA testing environment. Nearly all (96%) physicians responded that they would be willing to convert away from BRACAnalysis for competitive tests, and when asked to forecast five years out for both average BRCA price and Myriad s market share, the feedback was also concerning ($832 average price projection, 58% average for Myriad s market share). We also asked physicians how much influence payors would have on the decision to use a specific test and overall, physicians expect payors to play a significant role, with 21% answering that payors would have a lot of influence and 46% responding that payors would have some influence. On the positive side, we are favorably biased on several factors for Myriad, including: (1) the $270M Crescendo acquisition, as the company remains committed to diversifying away from BRCA; (2) continued strong cash flow generation and buyback activity; (3) fiscal 2014 consensus estimates that still appear conservative; and (4) the potential for several new products, including Prolaris and PARP inhibitors, which present intriguing opportunities to further diversify away from BRCA. Source: JPMorgan/Peterson, March 31, 2014 Oncology Indication: Multiple Keyword: Management/Strategy/Financials

8 GlaxoSmithKline: More RCC Patients Prefer Continuing Treatment with Votrient Than Sutent in a Phase III Preference Study Results from phase III patient preference study of GSK s Votrient (pazopanib) vs. Sutent (sunitinib) in advanced renal cell carcinoma were published in Journal of Clinical Oncology. The study (PISCES) showed more patients expressed a preference for continuing treatment with Votrient than Sutent. The objective of PISCES was to investigate patientreported treatment preference and certain health-related quality of life outcomes for patients with locally advanced and/or metastatic renal cell carcinoma (arcc or mrcc) who received no prior systemic therapy. The results showed that 70% of patients expressed a preference for pazopanib compared to 22% expressing a preference for sunitinib, as assessed by a questionnaire. This equates to a statistically significant difference of 49%. Eight percent of patients expressed no preference. The PISCES study was not designed to measure or compare the clinical efficacy of either pazopanib or sunitinib. One of the secondary endpoints in this study was assessing the reasons for patient preference. The most commonly cited reasons for preferring pazopanib were better quality of life and less fatigue. In patients preferring sunitinib the most common reasons were less diarrhoea and better quality of life. Faisal Mehmud, Head of US Oncology Medical Affairs, GSK, said: There are now a number of therapies for advanced kidney cancer and as a result clinicians are striving to understand which medicines may be suitable for different patients. We hope that the results of the PISCES study will provide additional insights from the patient s perspective into the treatment options available and further inform clinical practice. Source: Press Release, April 1, 2014 Oncology Indication: Kidney Keyword: Discovery & Research

9 Celgene: Expands Collaboration with Forma Therapeutics for Up to $600M, with a Possible Buyout; Companies Will Evaluate Emerging Families of Targets for New Drugs Celgene and Forma Therapeutics have agreed to a second collaboration with the possibility of two more, all valued at up to $600 million, and an option by Celgene to buy out its partner a year to the month that the companies launched their first partnership. Unlike their first hook-up, which focused on discovering, developing, and commercializing protein homeostasis target-regulating drug candidates, this second agreement expands across Forma s preclinical and future clinical development efforts, encompassing numerous protein target families and covering a broad range of therapeutic areas, Steven Tregay, Ph.D., Forma s President and CEO, said in a statement. The companies agreed to evaluate emerging families of targets for new drugs, with Celgene accessing Forma s drugdiscovery platforms and network of academic experts. Celgene has an option to license rights to select current and future Forma programs in exchange for undisclosed additional development and regulatory milestone payments. Celgene agreed to pay Forma $225 million in upfront cash under their collaboration, set to run 3½ years. In addition, Celgene has the option to enter into up to two additional collaborations with terms of two years each for additional payments totaling approximately $375 million. Should each collaboration succeed and Celgene opt to enter all three collaborations, they all would extend for a total of at least 7 ½ years. During the third collaboration term, Celgene has the exclusive option to acquire Forma, including the U.S. rights to all licensed programs, and worldwide rights to other wholly owned programs within Forma at that time. In return, Celgene agreed to oversee all global development activities and costs after completion of Phase I clinical trials. However, Forma retains U.S. rights to all assets licensed through the collaboration, including responsibility for manufacturing and commercialization. Forma will also maintain worldwide rights for products not licensed to Celgene. Source: Genetic Engineering & Biotechnology News, April 1, 2014 Oncology Indication: General Keyword: Partnerships/Business Developments