4th of July holiday special

Join Chimera Research Group for the best biotech insight! We are running a 4th of July holiday special for $299/year until Sunday, July 8th. 

www.chimeraresearchgroup.com/join

See some of our recent blog pieces here

https://www.chimeraresearchgroup.com/category/report/chimera-blog/

Best,

Patrick

Transitioning to Chimera Research Group

To All Visitors & Subcribers,

I want to thank you for visiting ChasingtheAlpha.com over the past few years. It has been my pleasure to provide what I hope has been the most relevant and insightful content in the biotech and pharmaceutical sectors.

I am proud to announce that Jason Chew, Tony Pelz, Tro Kalayjian, Richard Kursman, and I have co-founded Chimera Research Group, where I will be serving as a Senior Writer and Chief Research Officer. On Wednesday, October 12th, the site will officially launch.

Chimera Research Group will provide completely independent, actionable investment and trading ideas backed by comprehensive research and analysis for listed companies in the biotech and pharmaceutical sectors. Our coverage will focus on early stage companies with impending FDA decisions or clinical trial results, in addition to mid-to-large cap bio-pharma companies with known catalysts.

I appreciate your patronage and I hope you will continue to follow my work at Chimera Research Group, where my co-founders and I will provide the best content available in the bio-pharmaceutical sectors. Please visit www.ChimeraResearchGroup.com for more information.

Sincerely,

Patrick Crutcher

$PFE/$BMY score big with ELIQUIS(apixaban)

Pfizer($PFE) and Bristol-Myers Squibb($BMY) scored a huge win for ELIQUIS(apixaban) in their Phase 3 ARISTOTLE trial. ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), was a randomized, double-blind, multicenter, head-to-head trial, including 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. Now, the market had known that the drug had met the primary endpoint back in June, but with anticoagulant agents, the safety data is just as important. 

ELIQUIS will be 3rd to market out of the recently approved new anticoagulants Pradaxa(Boehringer Ingelheim) and Xaralto(Bayer/$JNJ). However, this clean safety data is a really big deal/success for $BMY and $PFE. So much so, that in my opinion, the data looks better than Pradaxa or Xaralto in Afib. They plan on submitting the NDA, EMA  end by year end. 

"ELIQUIS® (apixaban) was superior towarfarin for the reduction of stroke or systemic embolism with significantly less major bleeding in patients with atrial fibrillation in Phase 3 ARISTOTLE Trial. ARISTOTLE Demonstrated that ELIQUIS is the First Oral Anticoagulant to Significantly Reduce All-Cause Death. ELIQUIS, compared to standard of care warfarin, significantly reduced: risk of stroke or systemic embolism by 21 percent, risk of major bleeding by 31 percent, mortality by 11 percent."

Disclosure: Long $PFE Weekly calls and Sept $BMY calls

PFE/BMY ELIQUIS(apixaban) news wrap up with links to multiple articles 

NEJM article - Apixaban versus Warfarin in Patients with Atrial Fibrillation - http://bit.ly/q49394 

Forbes' Matthew Herper: Pfizer and Bristol Overtake Rivals In Multi-Billion Blood Thinner Market - http://onforb.es/rtunCn 

Forbes' - Pfizer and Bristol's ARISTOTLE Study Finds the Golden Mean of Anticoagulation - http://onforb.es/pguVe0 

Fierce Biotech - Pfizer, BMS unveil mega-blockbuster data on apixaban - http://bit.ly/q5pBaE 

Bloomberg - Pfizer, Bristol-Myers Experimental Blood Thinner Reduced Deaths in Study - http://bloom.bg/phjmdN 

"Pfizer and Bristol-Myers may now take 60 percent of the market for blood thinners to ward off strokes in people with an irregular heartbeat, according to analysts for ISI Group and Leerink Swann & Co. Leerink estimates sales of warfarin replacements will reach $7 billion to $9 billion a year."

From earlier, "Results of this caliber may mean that while the drug lags behind two rivals in the race to win approval in the U.S., it could still take up to half of the market, Christopher Schott, a New York-based analyst for JPMorgan Chase & Co., wrote in a note to investors before the data was public. Schott said a “best- case scenario” may add $1 billion in peak annual sales to the $2.8 billion he estimated Eliquis will generate by 2017." 

[ in my view, the data would seem to fall under best-case scenario. ] 

WSJ: Boost for New Stroke-Prevention Drug - http://on.wsj.com/qZ0L6T 

$BMY PR - LINK / Slides from ESC 2011(PDF)

8/8/2011 - More biotech capitulation and news roundup

If you haven't noticed, biotechs are still getting slaughtered left and right. One word to describe this: capitulation. Capitulation means to surrender or give up. In short, speculative money has run for the hills and is now hiding under a rock. Investing in biotech has never been easy nor risk-less, so it's one of the first industries to be dumped in a sell-off like this. Most biotechs are being dropped down to below cash per share levels and some even worse. This obviously creates some great "bargains", but be careful catching falling knives.

I am in all cash right now and keeping things close to the vest; intra-day trades with no overnight holds. Mostly watching and trading the indices via weekly options. Adapt to survive.

Anyways, some news from today.
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$CLSN Convenes Symposium of Leading Experts in Primary Liver Cancer - Yahoo! Finance - http://t.co/G5ySHdL

-- Note they will hold a conference call to discuss second quarter 2011 results at 11:00 a.m. ET.  

$ARRY 4Q/FY results - http://t.co/1cS77gX

- current cash $65 million with $28M coming in September from Genentech

- Genentech pays Array Biopharma $28m upfront in deal to combine co's ChK-1 inhibitor programs (GDC0425 & ARRY575) with $600M+ in backend payments

- expects $AZN to have data from 2 Phase 2 combo trials of AZD6244 in melanoma & NSCLC in coming months. Both are targeted trials, where the melanoma trial is going after those who are BRAF+ and the NSCLC for those who are KRAS+.

$FOLD 2Q Results - http://t.co/nv0v1u4 

- current cash of $83 million

- Phase 2 (Study 013) preliminary results of Amigal co-administered with enzyme replacement therapy (ERT) on track for 4Q11(for Fabry's disease)

$ONTY 2Q Results - http://t.co/JMYkPtM

- current cash of $66 million

- Stimuvax 2nd interim look now not expected until Q1 2012. 

• Now, I am sure the uber-bulls want to proclaim victory, but it's not that simple or easy. Clearly, it seems that patients are living longer than expected, which typically means that doctors are better at treating the disease in both groups. Also, too many employ circular logic to come to the conclusion that the delay is unduly bullish.

$KERX 2Q Results - http://t.co/d9ARz1h

- See Gekkowire's commentary here

- current cash of $52.5 million

- expects DSMB futility analysis in late August/September for the “X-PECT” trial using Perifosine in patients with colorectal cancer.

$LGND 2Q Results - http://t.co/M8Vq4Uf 

- current cash of $14.8 million

- lots of upcoming catalysts over the next few quarters (2nd Promacta Phase 3, etc.)/ see Analyst Day slide deck(PDF)

$ACHN 2Q Results - http://t.co/otQlEDs

- current cash $99.6 million

- 12-week cEVR results with ACH-1625 in genotype 1 later this year (Q4)

- results anticipated near the end of 2011 from a Phase 1 study evaluating ACH-2684 will include proof-of-concept data not only against genotype 1 but also HCV genotype 3.

$ALXA 2Q Results -  http://t.co/OhvABOE

- current cash $38.7 million

- NDA for AZ-004 was resubmitted on August 4th

$RGDX 2Q Results - http://t.co/c5iFpTf

$ECTE Announces Multiple Patents and Trademark Grants - http://t.co/Q5mZjIo

$DSCI Achieves Key MEDIHONEY® Sales Milestone - http://t.co/bGPJNcq

Biotech news to note(8/4/11); overall market in bear mode

Sorry that I have been light on blog posts recently. I've been dealing with moving into a new apartment, finishing up my summer session teaching and a side project. In that time, we've seen the market stumble, politicians fumble and fear take hold. I cashed out of most of my positions earlier in the week and have been sitting on my hands for the most part.

$DNDN's earnings/poor guidance caused a HUGE capitulation in biotech($NBI $BTK and $IBB were all down big). I don't think $DNDN's situation applies to most biotechs, but  not sure when the selling is going to end. I have a lot of stocks on my watch list!
_____________________________

Some of the news I picked up from after-hours and throughout the day. A lot of companies reported yesterday.

$MNTA Momenta Pharmaceuticals Reports $1.26 Earnings Per Share for the Second Quarter of 2011 - http://srph.it/pAc6zS

- Another incredible quarter for this company. In the CC, they noted a one time change in the royalty rates should another generic Lovenox enter the market; a 20-25% increase over previous arrangement. From high single digits to low double digits. $MNTA ended 2Q11 with $331M in cash and receivables(!). Exploring multiple partners for biosimilars program instead of one sole partner for the whole program.


$BIOD Biodel Reports Third Quarter Fiscal Year 2011 Financial Results http://t.co/GBOGWk3

- Cash of $42 million , completed Phase 1 testing of two new ultra-rapid-acting formulations(105 and 107) of recombinant human insulin, or RHI, for subcutaneous injection
- $BIOD - 3Q11 CC notes (8/4/11) - http://bit.ly/p3akmq  { courtesy of mcbio }


$SPPI Spectrum Pharmaceuticals Generates Cash from Operations, Reports Third Consecutive Profitable Quarter - http://aol.it/oW7ZJ6

- Fusilev $33.9 million, sales are down sequentially; no guidance given except they expect similar sales levels. Current cash around $165 million; Belinostat should complete enrollment in 2011, file NDA in 2012; still expect to file Apaziquone NDA in 2012

$THLD Threshold Pharmaceuticals Reports Second Quarter 2011 and Year to Date Financial Results - http://yhoo.it/oOtt4B

- Current cash of $31.5 million
- Topline TH-302 Phase 2 pancreatic cancer trial data at end of 2011 and Phase 1 leukemia data in second half of 2011


$SGEN Seattle Genetics Reports Second Quarter 2011 Financial Results - aol.it/pV7Doc

- Current cash of $424 million; expects to end 2011 with about $300 million
- FDA is scheduled to act on the two Biologics License Applications (BLAs) for ADCETRIS by August 30, 2011
- Stopped development on SGN-40 and SGN-70 programs


$SQNM Sequenom Reports Financial Results for the Second Quarter of 2011 - aol.it/nGaImi

- Current cash and equivalents $114 million; reported revenue of $13.3 million, net loss for the second quarter of 2011 was $20.9 million
- MaterniT21 is the brand name for its proprietary noninvasive trisomy 21 laboratory developed test (LDT)
- still expects to launch testing services commercially in late 2011 or early 2012


$PBTH PROLOR Biotech Announces Positive Top-Line Results From Phase II Trial of its Long-Acting Human Growth Hormone That Achieved All Key Study Goals - http://srph.it/nEKMAT

- weekly formulation going forward looks like 2mg per week of hGH-CTP, containing 50% of the cumulative weekly hGH dose
- Phase III trial is planned to begin in 2012


$VRML Vermillion Reports Results for the Second Quarter 2011 - http://srph.it/rv4iEH

- Cash and cash equivalents of $36.3 million
- Growth in OVA1 tests; 27% QoQ growth in test volume
- remains on track to yield top-line VASCLIR data during the third quarter of 2011


$ARQL ArQule Reports Second Quarter 2011 Financial Results - http://srph.it/osuSSi

- Current cash of $127 million; expects to end 2011 with between $85 and $90 million
- Tivantinib (ARQ 197) randomized Phase 2 trial in HCC anticipates having data toward the end of 2011 ( depends on event rate )
- Initiation of a randomized, open-label Phase 2 combination trial of tivantinib and erlotinib in NSCLC patients with KRAS mutations


Random news

$AMRN Amarin Phase 3 ANCHOR and MARINE Trial Data to be Presented in November at the American Heart Association's Scientific Sessions - http://srph.it/payYdu

$PTIE Pain Therapeutics Reports Q2 2011 Financial Results - http://srph.it/o9zLVM

$SCMP Sucampo Pharmaceuticals Reports Second Quarter 2011 and Year to Date Financial Results - yhoo.it/pYpJr0

$PACB Pacific Biosciences of California Announces Second Quarter Financial Results - aol.it/qjrOAs

$MNKD MannKind Corporation Reports 2011 Second Quarter Financial Results - http://srph.it/oBLt92

$AMLN and Takeda Discontinue Development of Pramlintide/Metreleptin Combination Treatment for Obesity - yhoo.it/r1QsaX

$EXEL CEO Discusses Q2 2011 Results - Earnings Call Transcript - bit.ly/oHACk9

$EXEL Announces Second Quarter 2011 Financial Results - http://t.co/xygjsip

$ITMN Reports Second Quarter 2011 Financial Results - aol.it/pN13yk

$NVO Novo Nordisk Raises 2011 Sales, Profit Forecasts on Higher Victoza Revenue - bloom.bg/qg5upX

Biotech news for 7/14

$VICL : Vical and Astellas Announce Worldwide License Agreements for TransVax(TM) Cytomegalovirus Vaccine - http://srph.it/oFfBGY

- $25 million upfront and $10 million once the Phase 3 design is finalized

$CBST : Cubist Pharmaceuticals 2Q11 Total Net Revenues $176.8M - http://srph.it/nB2Rs8

- Great quarter, but they're still spending a lot of cash on their pipeline.

$IPXL : Impax Pharmaceuticals Awarded Michael J. Fox Foundation Grant for Ongoing Research of IPX066 for Parkinson’s Disease - http://t.co/rSDmh0Q

- They hope to file an NDA in the 4th quarter.

$EXEL Exelixis notified investors that $BMY is dropping development on XL281. http://bit.ly/qBhCKW

$SGEN Seattle Genetics Announces Unanimous Recommendations from FDA Advisory Committee in Favor of Accelerated Approval of ADCETRIS™ for Post-Transplant Relapsed Hodgkin Lymphoma and Relapsed or Refractory Systemic ALCL - http://t.co/nJzqxvy

- AdComm went 'ok', but there was a lot of questions about the post-approval confirmatory Phase 3 they want $SGEN to run. 

In other news, $DCTH(5M shares) and $ECYT( 4.8M shares) are raising money.

Some biotech options movement to note

Some trades I saw on 7/13 that I thought I would point out.

$SGEN : Lots of put action in front of $SGEN's FDA advisory panel for Adcetris. Specifically, we saw 4500+ July $15, 2800+ July $17.5 and 1400 July $20 puts traded. See the screenshot for more info.

Briefing documents here - http://1.usa.gov/pnYKnL

$SQNM : 1100+ August $8 calls traded, open interest is only ~ 800. $SQNM has gotten some recent upgrades and has T21 results in Q4.

$ONTY : 1000 Nov. $11 and 1200 Aug. $8 calls traded. They have a 2nd interim look later this year for their Stimuvax trial.

$AMRN : 5000+ Dec. $15 calls (vs. open interest of 800+). We also saw 3000+ Dec. $15 and 1000+ Dec. $14 puts trade.

$AMGN : 1000+ Aug $60 calls traded(vs. open interest of 5000+). They should be announcing Phase 3 OncoVex results in melanoma sometime in the second half.

$HGSI : 700+ Aug $27 calls traded(vs. open interest of 400+). On July 21st, $HGSI will have their quarterly update; we should hear more about Benlysta sales.

$SPPI : Lots of call action today in the August series. Namely, 8000+ Aug $9(vs. 2600+ open interest) and 1300+ Aug $10 calls. I believe they have earnings on 8/2. See screenshot for more info on the trades.