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SPPI投资热点及参考策略
2011年3月22日
1. SPPI现金富裕, Approximately $104 Million。（Ref: 当前SPPI市值 $400 Million）
2. 有两个治疗癌症的药品去年以来一直销售旺盛，利润可观。2010 Consolidated Revenue $74 Million。
3. 下个月4/29 SPPI - PDUFA Date for Fusilev sNDA 。（这是第二次审批）
4. 有两个新药正在三期临床试验, 2011年Q2-Q4将有新结果发布。
当前SPPI投资热点及目标价：
今年以来SPPI股价一直在6-8之间徘徊，最近一直在7.9左右盘整。随着4月29日FDA第二次审批日期的临近，SPPI突破在即。
目标价：
1. 4月29日之前：10-13；
2. 如4月29日Fusilev获批（可能性较大），SPPI将跃至16-20，年内将稳定在20以上。
3. 如4月29日Fusilev再次被拒（也有可能），SPPI将暂时跌至7以下；（2009年10月9日Fusilev首次被拒，SPPI由10跌至4），但考虑当今SPPI已上市药物的巨大效益及其它新药试验结果，2011年内SPPI将回升到10以上。
当前SPPI投资参考策略：在FDA关键日期1个月之前应该及早动手:
1.目前价位（8左右）买入，至4月28日前卖出，有限但稳定盈利。
2.目前价位（8左右）买入，并买SPPI 5月的8刀PUT保护，持有到4月29日之后。（根据对DNDN和HGSI等的观察，临界的PUT和CALL在FDA决定日期之前往往双双上窜）。
3.买SPPI 5月的Call；
4. 同时买5月的Call和Put （straddle），4月29日将有巨浪。
风险与利润并存。下面是SPPI的一些最新资料，有兴趣的朋友可以参考。
Spectrum Pharmaceuticals（SPPI）Overview
“We are a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. Our strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. We market two oncology drugs, ZEVALIN and FUSILEV and have two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. We have assembled an integrated in-house scientific team, including formulation development, clinical development, medical research, regulatory affairs, biostatistics and data management, and have established a commercial infrastructure for the marketing of our drug products. We also leverage the expertise of our worldwide partners to assist in the execution of our strategy. Apaziquone is presently being studied in two large Phase 3 clinical trials for non-muscle invasive bladder cancer, or NMIBC, under strategic collaborations with Allergan, Inc., ("Allergan"), Nippon Kayaku Co. Ltd., ("Nippon Kayaku"), and Handok Pharmaceuticals Co. Ltd., ("Handok"). Belinostat, is being studied in multiple indications including a Phase 2 registrational trial for relapsed or refractory peripheral T-cell lymphoma, or PTCL, under a strategic collaboration with TopoTarget A/S or TopoTarget.”
Spectrum Pharmaceuticals Financial Results Highlights:
(1) Strong Financial Results Include a Nearly Five-Fold and Two-Fold Increase in Fourth Quarter and Fiscal 2010 Product Revenue Vs. Fourth Quarter and Fiscal Year 2009, Respectively
(2) Three and 12-Month 2010 Consolidated Revenues Approximately $34 Million and $74 Million, Respectively
(3) Three and 12-Month 2010 Product Revenues Approximately $31 Million and $61 Million, ZEVALIN® Fourth Quarter and Fiscal Year 2010 Sales Up 54% and 84% Vs. Fourth Quarter and Fiscal Year 2009, Respectively
(4) FUSILEV® Fiscal Year 2010 Sales Up 156% Vs. Fiscal Year 2009
(5) Approximately $104 Million In Cash, Cash Equivalents and Investments as of December 31, 2010, Up From $92 Million as of September 30, 2010
2011/2012 Corporate Events and Potential Valuation Catalysts:
1. FUSILEV® : FDA PDUFA Action date in metastatic colorectal cancer by April 29, 2011.
2. ZEVALIN® : (1)Anticipate FDA decision on bioscan removal before the end of 2011; (2) Initiation of a Diffuse Large B-Cell Lymphoma trial in 2011.
3. Belinostat: Complete enrollment in registrational study and file rolling NDA for Peripheral T-Cell Lymphoma in 2011/2012.
4. Apaziquone: Anticipate filing NDA for bladder cancer in 2012.
On April 29, 2011, the FDA, upon reevaluation, will decide whether it will approve Spectrum Pharmaceuticals' (SPPI) supplemental new drug application (sNDA) for Fusilev, which is indicated for patients with metastatic colorectal cancer (mCRC).
On 3/7/2008, FDA approved SPPI's new drug application (NDA) for FUSILEV in patients with osteosarcoma (bone cancer) after high-dose methotrexate therapy to diminish toxicity. Under this indication, FUSILEV is designated as an orphan drug.
On October 9, 2009. FDA rejected SPPI’s new drug application (NDA) for Fusilev in patients with metastatic colorectal cancer (mCRC). The agency said SPPI failed to demonstrate that Fusilev was non-inferior to racemic or generic leucovorin. The SPPI share price dropped to $4 from $10.
On 11/29/2010, FDA accepted SPPI resubmission of sNDA for FUSILEV in patients with mCRC.
On 1/4/2011, SPPI submitted additional sNDA for a Ready-to-Use version of FUSILEV in patients with mCRC.
Since Fusilev has been sold in the EU for more than a decade under the mCRC indication, SPPI has compiled data from thousands of patients across Europe and other countries (EU+), who received the treatment. In addition to the results of three Phase 3 trials, the EU+ patient data should confirm that Fusilev is, in fact, non-inferior to generic leucovorin.
After reviewing SPPI's sNDA resubmission, which consists of more than 10 years of data from colorectal cancer patients in countries all throughout Europe and some countries outside the EU, where the drug has been approved and administered to thousands of patients, it is likely the US regulators will finally approve Fusilev for mCRC in the US.
Drugs are very short (奇缺) for for patients with metastatic colorectal cancer (mCRC). By approving Fusilev, the FDA will help alleviate the current shortage as well as boost supplies to meet the increasing demand from a growing, aging patient population.
With FDA approval and full reimbursement, I also believe that many doctors will gravitate towards Fusilev. Here's why:
1.Reliability - Fusilev supplies should be sufficient to meet future demands (excluding the ongoing, short-term Cangene plant closing).2.Ready-to-Use - SPPI recently submitted a second sNDA for a Ready-to-Use version of Fusilev that will make it more convenient for end-users to administer the treatment to patients. That's good stuff.3.Less Toxicity and more effective - Fusilev has been shown in some studies to be less toxic and more effective than its generic competitor. With annual sales of $200 million in the EU, it certainly appears that doctors overseas prefer the potentially less toxic levoleucovorin (Fusilev) over the generic. Hmm. Post FDA approval, Fusilev will have $10 million / quarter potential. Coupled with continued growth of Zevalin sales, SPPI could generate $100 million+ in total revenue during FY 2011.
Target price：before the PDUFA date (4/29/2011), it is anticipated shares will quickly penetrate the 9/4/09 high of $10. With approval, price will jump to $14~$20 easily (Whereas if Fusilev is rejected again, share price will drop to $7 or lower). With total revenue between $80 and $100 million, SPPI will trade above $20 in 2011.
It's going to be an exciting year for SPPI, full of expected milestones long waited from investors. These are the main:
Q2 2011: FDA response to sNDA for Fusilev approval in colorectal cancer (PDUFA date 29 of April)
Q2/Q4 2011: PTCL Belinostat Trial expexted to complete enrollment and top-line results.
During 2011 more results are expected in important Belinostat trial conducted by investigators. Among that Belinostat in ovarian cancer, thymoma cancer and sarcoma.
Q4 2011: NDA for Belinostat in PTCL (Peripheral T-cell lymphoma).
Q2-Q4, 2011, The top-line data of phase III two pivotal trial of Eoquin in bladder cancer, a real "switch-on" event for a company on the verge of a great success...depending, of course, like always, on what the results will be.
Belinostat may be approved in late 2011 to early 2012, and Eoquin in 2012. |
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发表于 2011-3-22 04:31 AM
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发表于 2011-3-22 09:04 AM
