full-time investing; total portfolio up over 130% in 2009; but 2010 sucks!
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OT: Bipolar Illness, Lentinman (Martin Manley):
My opinion only: Lentinman (Martin Manley) who used to be a regular here until a couple of years ago, seems to have suffered from Type 2 Bipolar Illness before he killed himself recently.
He prided himself on not going to the doctor or being sick much during his lifetime, he did not mention this about himself, I assume he may never have been diagnosed and therefore was untreated for the disease. This is only my personal guess, based on reviewing a lengthy video on Bipolar Illness. His personal history of sleeplessness, eating one meal a day, skipping food often, feelings of guilt about his failed marriages, obsessive behavior (working most hours of the day; inability to relax), and occasional grandiosity, planning suicide for over a year, and completed suicide (clinically there is no such thing as a "successful suicide", lead me to think that Type 2 Bipolar Illness must have been the case.
Type 2 Bipolar Illness is characterized by high productivity and occasional Minor Manic episodes (vs. Major Manic episodes) and occasional Minor Depressive episodes (vs. Major Depressive episodes). Type 2 Bipolar Illness is different from Type 1, which is characterized by occasional Major Manic episodes lasting a few weeks and Major Depressive episodes typically lasting up to 6 months). Type 1 Bipolar Illness is a more clinical name for "Manic Depressive" disorder.
In any case, Bipolar Illness is a very treatable genetic disorder characterized by a chemical imbalance in the body, and it often goes undiagnosed unless a Major Manic episode occurs.
The above explanation is my own personal guess after having watched the very lengthy (almost 2 hour) video below:
http://vimeo.com/68533867
The reason I watched the video is that my brother-in-law was diagnosed about a year ago with Type 2 Bipolar Disease. As I watched the video, I kept thinking about Martin Manley, whose website I reviewed extensively. In my mind, the major difference between Martin Manley and my brother-in-law is that Martin appears not to have ever been diagnosed or treated for his condition. Had he been treated, he may have decided against suicide, but we will never know for sure.
I reiterate that the above opinions are mine alone; I cannot say for sure what Martin Manley's situation really was; I have just decided to share my opinion here after doing my small amount of DD on the topic. There is certainly no ill will intended toward Martin Manley. As many of you here, I regard him highly as one of the more valuable contributors to the Value Microcap community over the years!
Although Yahoo took down his website, it is still mirrored here:
http://martinmanleylifeanddeath.com.nyud.net/
Best Regards to all of you,
stock_peeker
12:33 JPM: Headlines that JPM will look to sell off commodity assets in September.
Briefing.com Comment: This was expected following news that the Fed was reviewing regulations on banks ability to hold physical commodities as well as the July announcement that JPM would be exploring strategic alternatives for the business.
12:33 JPM: Headlines that JPM will look to sell off commodity assets in September.
Briefing.com Comment: This was expected following news that the Fed was reviewing regulations on banks ability to hold physical commodities as well as the July announcement that JPM would be exploring strategic alternatives for the business.
For the record, Lentinman's claim to have buried his gold and silver was an amusing cruelty joke on his part, which probably led to more website hits. It was a good example of his sense of humor (wanting to get some of the "village idiots" to self-identify). Bunches of people showed up at the arboretum that included his stated coordinates for the buried treasure, and the arboretum had to call the cops to chase away people with shovels. Many who wanted not to pay the arboretum's $5 entry fee simply jumped the fence and headed for the spot (reminds me of Woodstock).
However, for my part, I would not want to over-romanticize his suicide. IMHO it was probably the act of a deeply disturbed and self-isolated man. Excessive time spent on the internet does isolate us in many ways afterall. In other words, I must assume that he did not have enough loving people and enjoyable recreational activities in his own life.
Depression probably played a part, but in his honor, I must admit we do not know enough about what was not mentioned on his website to make informed guesses (or state probabilities) about the various reasons and situations that made him take his own life.
RIP, Martin Manley (our Lentinman).
RIP, Lentinman! Martin Manley committed suicide yesterday.
http://www.martinmanleylifeanddeath.com/
That site may not be active due to the host's policy; if you cannot see it using the link above, it has been mirrored here:
http://martinmanleylifeanddeath.com.nyud.net/
Here is an article that appeared today about his suicide:
http://www.tonyskansascity.com/2013/08/shock-overland-park-dude-martin-manley.html
In this article, he supposedly even posted the location of his gold and silver.
http://www.kernelmag.com/features/report/4554/death-in-the-public-square/
MMT.v/MAUXF released a VERY NICE quarterly report this afternoon. Great Q2 production (especially compared to Q1, which was a bust). Excellent writeup on accomplishments and plans. New item is plan for the new rig to re-enter UMU-8 and drill to deeper sands, supporting new reserve estimates. Of course UMU-10 and UMU-11 results will add to the reserves, too. After drilling UMU-8 to depth they will commence with re-entering a couple of other existing wells and turn them into producing horizontal. Good plan; nicely laid out; best quarterly report I remember seeing in quite some time. Should move the stock Friday (or I'm just whistlin' Dixie).
http://finance.yahoo.com/news/mart-announces-financial-operating-results-210459985.html
AMAVF has had a huge run, for instance, up 125% since early May. Don't you think it's probably a good stock to sell here?
Look at this Glyphosate vs. Autism chart:
http://www.higher-health.org/2013/06/monsantos-roundup-linked-to-autism.html
Look at this chart correlating autism to use of Glyphosate.
Not definitive proof, but certainly implicates Glyphosate.
DGLY finally popped today on big order news. Second biggest order in their history. Well, fine. I got out after 2 months of watching it smell like "rotten peaches, rottin' in the morning sun".
3D printing companies have had a great run, and as a result, their insiders are cashing in by doing additional public stock offerings and private placements. Examples are ONVO (Organovo) and SGLB (Sigma Labs).
The moderator has probably made a ton of money holding these stocks for the last year or so, and he seems to have a tendency to look at 3D Printing Stocks thru rose colored glasses since he is long many of the ones he comments on. This is not a condemnation, just an observation from my point of view.
Arcam (profitable) appears to be one of the better stocks out there, but when the whole sector is overvalued (high P/Es across the board), investors should be wary and maintain tight stops. Even so, it will be almost impossible to prevent damage to the portfolio when the companies offer cheap stock to their insiders and special connections thru private placements (like SGLB certainly did).
Disclosure: Currently own no 3D Printing Stocks. Lost a little on SGLB recently; made a little on ONOV in the past. Quite honestly I just don't see the sector as suitable for "value investors" like myself.
Good luck!
stock_peeker
So you were selling at the time you were agreeing that SGLB looks like it could bust out? Oh, OK, that's "credibility".
3DP', where is this publicly available trading information that establishes your credibility? I don't see it on this 3D Printing Stocks board or your personal website 3DPrintingStocks.com anywhere. Please post a link.
SGLB: Candor has it that on 21 July you agreed that SGLB appeared ready to bust out. At that point it was eleven cents ($0.11), from which it did not bust out. Yesterday (10 days after your "bust out") it was down about 60%. Today it is all the way up to a nickel.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90169139
Admitting you were wrong on SGLB is a reasonable thing to do, and it would add to your credibility. It happens to all of us.
Regards,
stock_peeker
SGLB ... Pardon my candor, but there's no reason to think a bottom is in when they just issued 120million shares at .01/share. You seem to be talking up your own book.
Mart management must have decided that accomplishing things would be counterproductive, as they would have to remove items from their list of future catalysts.
KNDI doing very well today (up 10%) after announcing delivery of pure Electric Vehicles (EVs) to Hangzhou's Public EV sharing system. Note that KNDI is profitable (with help from gov't and JVs).
Kandi Technologies Announces the Delivery of First 100 Kandi-Geely Co-Developed Pure EVs for the Official Launch of Hangzhou's Public EV Sharing System
3 hours 18 minutes ago - DJNF
Kandi Technologies Announces the Delivery of First 100 Kandi-Geely Co-Developed Pure EVs for the Official Launch of Hangzhou's Public EV Sharing System
JINHUA, China, July 26, 2013 (GLOBE NEWSWIRE) -- Kandi Technologies Group, Inc. (the 'Company' or 'Kandi') (Nasdaq:KNDI), today announced that the first 100 Kandi-Geely co-developed Pure EVs were delivered for the official launch of the public EV sharing system in Hangzhou City. The first pure EV smart vertical parking and charging facility was recently completed on schedule and started its trial operation. As previously announced, Hangzhou City has laid out an ambitious five-year plan to establish a mini-public transportation system which will include up to 100,000 self-serving rental EVs and all necessary service infrastructure, such as pure EV smart vertical parking and charging facilities, throughout Hangzhou City.
(To view an image, please visit http://orders.newsfilecorp.com/files/2079/6180_kandi_2.jpg)
Since the initial announcement in June, the planned pure EV sharing system has been well received by Hangzhou consumers as well as local political leaders. Ms. Lihua Wang, the Party Secretary of Xihu District, Hangzhou City along with her government delegation visited the first pure EV smart vertical parking and charging facility located in Gudang Technology Park on July 24(th) to inspect the initial operation to ensure the successful execution of the Hangzhou public EV sharing system.
During the visit, Mr. Xiaoming Hu, the Chairman of Kandi & the General Manager of Zhejiang Kandi Electric Vehicles Co, Ltd. (the "JV Company"), Mr. Jinliang Liu, the Vice President of Geely Auto Holding Group (the "Geely") and the Vice President of Sales & Marketing for the JV Company, and other core team members expressed the appreciation for the visit and the unwavering support from the local government. Mr. Hu and Mr. Liu provided to the delegation a detailed overview on the scope of work for the Hangzhou public EV sharing system and the advantages this project will bring to the city environment and its citizens' commutes.
The Party Secretary Ms. Wang was very satisfied with the progress Kandi has achieved and said in her remarks at the end of her tour, "To establish a mini-public transportation system by using pure EVs greatly enhanced our citizen's convenience for efficient transportation. It is also a giant step forward in terms of improving the urban transportation and the environment. We will continue to provide all government support to Kandi in order to complete the delivery of 5,00010,000 Kandi pure EVs in Hangzhou City within the next year. We are aiming to establish Xihu District as a national model to implement the public EV sharing system."
About Kandi Technologies Group, Inc.
Kandi Technologies Group, Inc. (Nasdaq:KNDI), headquartered in Jinhua, Zhejiang Province, is engaged in the research and development, manufacturing and sales of various vehicles. Kandi has established itself as the one of the world's largest manufacturer of pure electric vehicles (EVs), Go-Kart vehicles, and tricycle and utility vehicles (UTVs), among others. More information can be viewed at its corporate website is http://www.kandivehicle.com.
Safe Harbor Statement
This press release contains certain statements that may include "forward-looking statements." All statements other than statements of historical fact included herein are "forward-looking statements." These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the risk factors discussed in the Company's periodic reports that are filed with the Securities and Exchange Commission and available on the SEC's website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
CONTACT: Kandi Technologies Group, Inc.
SPECIAL REPORTS | Updated: 25-Jul-13
Strategies for profiting from various market-driven themes or events using stocks and/or options.
Weekly Biotech/Pharma Volatility Tracker -- GTXI slide continues; BCRX surges on positive data
GTXI shares have declined 25% on continued concern about the upcoming release of Phase 3 data for enobosarm. BCRX shares have more than doubled on positive Phase 1 data. Check out the "Recent Events" section and Anticipated Movers list below for more information on these catalysts and to identify others in the coming weeks. Finally, be sure to use our Calendar of Upcoming Events to prepare for the many catalysts scheduled for 2013.
Recent Events
GTx (GTXI) shares have declined approximately 25% over the course of the week. Last Friday the company announced a corporate update and its second quarter financial results. Management said that the highly anticipated topline results from the company's Phase 3 trial of enobosarm for the treatment of muscle wasting in patients with advanced non-small cell lung cancer will not be provided until, "later this quarter." Shares hit 52-week highs of $7.24 on June 18 in anticipation of the enobosarm data but have pulled back significantly over the past few weeks on concerns that the run up was overdone. GTx was listed on our anticipated movers table last week.
BioCryst Pharmaceuticals (BCRX) has had an amazing week, rising from last Friday's opening price of $2.15 to highs of $5.02 yesterday. The move began with an upgrade to Market Outperform from Market Perform at JMP securities last Friday, which sent shares higher by about 5%. On Monday the company announced that its Phase 1 clinical trial of orally-administered BCX4161 in healthy volunteers successfully met all of its objectives. Management said, "The safety, tolerability, drug exposure and on-target kallikrein inhibition results of this Phase 1 trial strongly support advancing the development program into a Phase 2a study in hereditary angioedema (HAE) patients." BCX4161 is a novel, selective inhibitor of plasma kallikrien in development for the prevention of attacks in patients with HAE. Biocryst was listed on our Anticipated Movers table last week.
Sarepta Therapeutics (SRPT) jumped back into the conversation on Wednesday after announcing that it plans to submit an NDA to the FDA for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) in the first half of 2014. There was serious concern that Sarepta's clinical data would not be sufficient to support an approval, however, it appears as if the FDA is willing to be flexible. The FDA would not commit to declaring dystrophin an acceptable surrogate endpoint under the CFR 314 Subpart H Accelerated Approval pathway prior to the NDA filing. Shares spiked sharply higher by 20+ points initially but ended up down nearly 20% at the end of the day. Sarepta was listed on our Anticipated Movers table last week.
OXiGENE (OXGN) shares spiked higher by as much as 54% last Friday after announcing it received orphan drug designation from the European Medicines Agency for ZYBRESTAT (fosbretabulin tromethamine) for the treatment of ovarian cancer. Shares have given up nearly all gains over the course of the week.
Shares of Celsion (CLSN) also jumped higher last Friday on the news that the company entered into a Memorandum of Understanding with Zhejiang Hisun Pharmaceutical to pursue ongoing collaborations for the continued clinical development of ThermoDox as well as the technology transfer relating to the commercial manufacture of ThermoDox for the greater China territory. In what seems to be a trend among cheap biotech stocks receiving good news, shares were unable to hold on to much of the gains and are currently only up slightly from pre-announcement levels.
Uroplasty (UPI) shares surged higher by approximately 35% on Tuesday. The company announced the completion of a review of its internal control over financial reporting and said it did not result in any changes in previously announced financial results or financial statements for prior reporting periods.
Transition Therapeutics (TTHI) received two pieces of good news. Last Thursday, after the close, the company announced that the FDA granted Fast Track Designation to the development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms in Alzheimer's disease. Tuesday evening the company announced the exclusive licensing of worldwide rights to a novel small molecule transcriptional regulator, TT-601, from Eli Lilly (LLY) for the treatment of osteoarthritis pain. TT-601 has completed preclinical development to date and Transition anticipates can enter the clinic in the first half of 2014. The stock is up approximately 40% since last week's report.
Array Biopharma (ARRY) announced positive results from its Phase 2 trial or ARRY-502 for the treatment of mild to moderate persistent allergic asthma. ARRY-502 achieved the primary endpoint, significant improvement in pre-bronchodilator Forced Expiratory Volume in one second (FEV1), a measure of lung function. Shares rose approximately 10% on the news.
CombiMatrix (CBMX) announced it entered into a contractual agreement with the health insurer, Blue Shield of California, for coverage of its diagnostic laboratory services. Blue Shield of California is the third largest health insurance carrier in the state, adding over 3 million covered lives and enabling its members access to CombiMatrix's molecular diagnostic solutions and comprehensive clinical support -- specializing in prenatal, miscarriage and pediatric healthcare. Shares rose as much as 28% on the news.
Neostem (NBS) shares are up over 20% this week. The company announced on Tuesday that it has met the listing criteria for the NASDAQ Capital Market and will move its listing from NYSE MKT to the NASDAQ Capital Market effective with the start of trading on August 5, 2013.
With earnings season well underway a number of stocks are seeing large moves. Notable gainers after reporting earnings include Healthstream (HSTM +12%), Align Technologies (ALGN +9%), PetMed Express (PETS +9%), Illumina (ILMN +11%), Boston Scientific (BSX +11%), and Medidata Solutions (MDSO +18%). A few decliners on earnings are Intuitive Surgical (ISRG -11%), Community Health Systems (CYH -9%), and Sequenom (SQNM -30%).
Two stocks have declined after pricing offerings: Oxygen Biotherapeutics (OXBT -33%) and AEterna Zentaris (AEZS -22%).
Trading Ideas, Anticipated Movers & Upcoming Events
Anticipated Movers:
Volatility remains high in several stocks on our Anticipated Movers list, most notably GTXI and VICL. One new addition to the list is OPTR. Volatility moderated or near term catalysts have been eliminated in BCRX, SRPT, OREX, and MDVN, which have been removed from the list.
Looking at the bigger list, implied volatility is elevated in a large number of biotech/pharmacy stocks, including the following: GTXI, VICL, MNKD, MPE, LNK, PTR, CNDO, and DNDN. These elevated volatility levels are indicative of expectations for greater volatility in these stocks in the future.
Anticipated Movers Table:
Ticker Price Implied Volatility Historical Volatility Implied vs. Historical 1-day move based on historical Current implied 1-day event SD Event Date
GTXI 4.40 256% 102% 2.5x 6.4% 17.3% GTx is a is a biopharmaceutical company focused on the treatment of cancer, cancer supportive care, and other serious medical conditions. On April 15, 2013 the company announced that an independent Data Safety Monitoring Board recommended GTx continue its two pivotal Phase 3 clinical trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer. The company expects to receive topline data in the third quarter of 2013. A negative article by biotech blogger Adam Feuerstein sent shares lower by approximately 25% on July 10. By 9/30/2013
VICL 3.46 173% 40% 4.4x 2.5% 11.2% Vical's lead development program, Allovectin, is currently in a Phase 3 registration trial vs. chemotherapy in patients with metastatic melanoma. A survival data sweep conducted in March 2013 confirmed that the target number of death events for the secondary endpoint (overall survival) should be reached in mid-2013. The independent assessment and adjudication process for the primary endpoint (response rate at 24 weeks or more after randomization) is advancing through final audits and quality checks, and the company expects the adjudicated response data to be locked in July 2013. Top-line results for both endpoints are expected to be released during the third quarter of 2013. The company will report second quarter financial results on Thursday, August 1, 2013. By 9/30/2013
MNKD 7.16 150% 63% 2.4x 4.0% 10.2% MannKind focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. On June 17, 2013 the company announced that all follow-up visits have been completed for the patients enrolled in Study 175, a Phase 3 clinical study of AFREZZA (insulin human [rDNA origin]) inhalation powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation inhaler. MannKind expects to release data from this study later this summer. Mid 2013
AMPE 5.91 128% 55% 2.3x 3.4% 8.8% Ampio Pharmaceuticals focuses on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampion, for the reduction of pain in osteoarthritis of the knee, is being evaluated in the SPRING trial. Clinical results are expected in the third quarter of 2013. By 9/30/2013
NLNK 17.27 127% 52% 2.5x 3.3% 8.7% NewLink Genetics' portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. The company recently presented positive results from multiple Phase 1 and Phase 2 trials at ASCO. NewLink is currently conducting a Phase 2b/3 trial comparing tergenpumatucel-L to docetaxel for patients with previously treated NSCLC. Analysts at MLV & Co and Cantor Fitzgerald expect interim data from the company's Phase 3 trial of algenpantucel-L (HyperAcute pancreas) by mid-year. Mid 2013
OPTR 13.29 108% 44% 2.4x 2.8% 7.4% Optimer Pharmaceuticals' DIFICID, a macrolide antibacterial drug, was approved by the FDA on May 27, 2011, for the treatment of Clostridium difficile -associated diarrhea. The company has been the subject of takeover rumors for months, with reported interest from Cubist Pharmaceuticals, Astellas Pharma, Salix Pharmaceuticals, and AstraZeneca. Reuters said that Cubist offered to buy the company for $20 per share in August of last year. Ongoing
CNDO 7.86 103% 62% 1.7x 3.9% 7.6% Coronado Biosciences' two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML), multiple myeloma and solid tumors. On July 1, 2013 the company announced it completed enrollment of TRUST-I, its Phase 2 clinical trial with TSO in 250 Crohn's disease patients. Coronado expects to report top-line data in the fourth quarter of 2013. A second interim analysis of data from the TRUST-II trial in Europe is also expected in the second half of 2013. The company will report second quarter financial results on Monday, August 5, 2013. 8/5/2013
DNDN 4.50 101% 36% 2.8x 2.3% 6.8% Dendreon's first product, PROVENGE, for the treatment of prostate cancer, was approved by the FDA in April 2010. The company has recently undergone cost-saving measures and has ongoing clinical trials combining PROVENGE and other cancer drugs. On June 28, 2013 the company announced that the European Medicines Agency Committee for Medicinal Products for Human Use adopted a positive opinion recommending PROVENGE for approval. The company is scheduled to report second quarter financial results on August 8, 2013 after the close. 8/8/2013
*The Current implied 1-day standard dev. is the 1-day, 1-standard deviation move in the stock, based on the implied 1-day event volatility. Based on current options prices, the underlying stock is expected to remain within a +/- 1 standard deviation range, about 2/3 of the time, and within a +/- 2 standard deviation range about 95% of the time.
Calendar of Upcoming Biotech/Pharmacy Events
= Highly Anticipated
March 2013
Date Ticker Company Optionable Event Product Treatment Briefing Notes/Links
3/1/2013 ZGNX Zogenix N PDUFA Zohydro ER Chronic pain DELAYED
On February 26, 2013 Zogenix was informed by the FDA that it is unlikely to receive an action letter for Zohydro ER (hydrocodone bitartrate extended-release capsules) by the PDUFA date of March 1, 2013. The FDA indicated that they are preparing to take action on the Zohydro NDA in the summer 2013. While they declined to provide any specific reasons for the delay, Zogenix has concluded the FDA are working on several broader opioid-related issues that need to be addressed prior to an action.
July 2013
Date Ticker Company Optionable Event Product Treatment Briefing Notes/Links
7/19/2013 ALPMY
(OTC listing) Astellas Pharma N PDUFA Astagraf XL Prophylaxis of organ rejections APPROVED
On July 19, 2013 the FDA approved ASTAGRAF XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.
7/23/2013 ABBV AbbVie Y Advisory Committee Meeting Humira (adalimumab) Spondyloarthritis NEGATIVE VOTE
On July 23, 2013 the Arthritis Advisory Committee voted against recommending approval of HUMIRA (adalimumab) for the proposed indication of active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation by elevated CRP or MRI, who have had inadequate response or are intolerant to nonsteroidal antiinflammatory drugs.
7/27/2013 FRX Forest Laboratories Y PDUFA Levomilnacipran Major Depressive Disorder On September 27, 2012 Forest Laboratories and Pierre Fabre Laboratories announced that Forest submitted an NDA to the FDA for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of Major Depressive Disorder (MDD) in adults. The expected PDUFA date is July 27, 2013.
August 2013 & Beyond
Date Ticker Company Optionable Event Product Treatment Briefing Notes/Links
8/2/2013 TKPYY Takeda N PDUFA Vortioxetine Major Depressive Disorder On October 2, 2012 Takeda Pharmaceutical and H. Lundbeck A/S announced the submission of an NDA to the FDA for investigational agent vortioxetine (Lu AA21004) for the treatment of major depressive disorder in adult patients. The estimated PDUFA date is August 2, 2013.
8/11/2013 BAYRY Bayer N PDUFA Riociguat Chronic thromboembolic pulmonary hypertension On April 8, 2013 the FDA granted a priority review for Bayer Healthcare's riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent CTEPH after pulmonary endarterectomy (PEA) and pulmonary arterial hypertension (PAH). The PDUFA date is expected to be August 8, 2013.
8/26/2013 QXRPY
(OTC Listing) QRxPharma N PDUFA (NDA) Moxduo Acute pain On March 14, 2013 the FDA set August 26, 2013 as the PDUFA date for QRxPharma's NDA for MOXDUO for the treatment of acute pain. An FDA Advisory Committee will discuss the NDA on July 17.
By
8/31/2013
(estimated) MRK Merck Y PDUFA (NDA) Sugammadex sodium injection Reversal of neuromuscular blockade Merck announced on January 7, 2013 that the resubmission of the NDA for sugammadex sodium injection was accepted by the FDA. Merck expects the review to be completed in the first half of 2013. Sugammadex sodium injection is the company's investigational agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium (neuromuscular blocking agents). An FDA Advisory Committee will review the NDA on July 18, 2013.
9/3/2013 GSK GlaxoSmithKline Y PDUFA Trametinib Metastatic melanoma On May 1, 2013 the FDA extended the PDUFA date of trametinib by three months to September 3, 2013. The extension is to allow the FDA sufficient time to review the submission of additional data. Trametinib, a MEK inhibitor, is for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.
9/6/2013 AUXL, BSTC Auxilium and BioSpecifics Technologies Y PDUFA XIAFLEX Peyronie's disease On December 27, 2012 the FDA accepted for filing and granted standard review status to Auxilium's sBLA for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease. The PDUFA date is September 6, 2013. BioSpecifics is partnered with Auxilium for XIAFLEX.
9/13/2013 DCTH Delcath Y PDUFA Melblez Kit Unresectable metastatic ocular melanoma in the liver On April 8, 2013 Delcath announced that the FDA extended the PDUFA date of Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. The PDUFA date is now September 13, 2013. On May 2, 2013 the FDA's Oncologic Drugs Advisory Committee voted 16-0 that the benefits of treatment with the Melblez Kit do not outweigh the risks.
9/14/2013 SGEN Seattle Genetics Y PDUFA (sBLA) ADCETRIS (brentuximab vedotin) Hodgkin lymphoma and systemic anaplastic large cell lymphoma On May 14, 2013 the FDA accepted Seattle Genetics' sBLA supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The FDA is expected to take action on the application by September 14, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.
9/21/2013 CELG Celgene Y PDUFA (sNDA) Abraxane Pancreatic Cancer On May 23, 2013 Celgene announced that the FDA assigned a Priority Review designation to the sNDA for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first–line treatment of patients with advanced pancreatic cancer. The PDUFA date for the sNDA is September 21, 2013.
9/27/2013 GIVN Given Imaging Y PDUFA PillCam COLON 2 Visualization of the lower gastrointestinal tract On November 27, 2012 Given Imaging filed an FDA application seeking regulatory clearance to market its PillCam COLON 2 for visualization of the lower gastrointestinal tract. Given's CEO said he expects approval by the end of the third quarter or the beginning of the fourth quarter.
9/28/2013 JNJ Johnson & Johnson (via Janssen R&D) and Medivir (private) Y PDUFA Simeprevir (TMC435) Hepatitis C On March 28, 2013 Janssen R&D (a JNJ company) and Medivir submitted an NDA to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients. The application was granted a priority review. The anticipated PDUFA date is September 28, 2013.
10/3/2013 LGND, PFE Ligand Pharmaceuticals and Pfizer Y PDUFA Bazedoxifene / conjugated estrogens Vasomotor symptoms and vulvar and vaginal atrophy On December 13, 2012 the Ligand Pharmaceuticals and Pfizer announced that the FDA accepted for review an NDA for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, as well as the prevention of postmenopausal osteoporosis. The PDUFA date is October 3, 2013.
10/6/2013 JNJ Johnson & Johnson (via Janssen R&D) Y PDUFA (sBLA) Stelara Psoriatic arthritis On December 6, 2013 Janssen Biotech and Janssen Biologics announced the submission of an sBLA to the FDA requesting approval of STELARA (ustekinumab) for the treatment of adult patients with active psoriatic arthritis. Janssen Biotech is one of the Janssen Pharmaceutical companies of Johnson & Johnson. The estimated PDUFA date is October 6, 2013.
10/14/2013 ATRS Antares Pharma Y PDUFA Otrexup Rheumatoid arthritis On December 17, 2013 Antares Pharma announced the submission of an NDA to the FDA for OTREXUP, a combination product for the delivery of methotrexate (MTX) using Medi-Jet technology. OTREXUP was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and moderate to severe psoriasis. The PDUFA date is October 14, 2013.
10/16/2013 AMRN Amarin Y Advisory Committee Meeting Vascepa High triglycerides The FDA will convene an advisory committee on October 16, 2013 in connection with the its review of the sNDA seeking approval for the use of Vascepa (icosapent ethyl) capsules as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and <500 mg/dL) with mixed dyslipidemia. The FDA has assigned a PDUFA date of December 20, 2013 for completion of its review of the sNDA.
10/17/2013 PSDV pSivida Y PDUFA Iluvien Chronic diabetic macular edema On May 1, 2013 pSivida announced that the FDA acknowledged receipt of the resubmission of the NDA for ILUVIEN for treatment of chronic diabetic macular edema (DME) and stated that the resubmission was considered a complete, class 2 response to the FDA’s November 2011 complete response letter. The new PDUFA date is October 17, 2013.
10/21/2013 AMAG AMAG Pharmaceuticals Y PDUFA (sNDA) Feraheme Iron deficiency anemia On March 6, 2013 the FDA accepted AMAG Pharmaceutical’s sNDA for Feraheme (ferumoxytol) Injection for Intravenous use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to adult patients with IDA who have failed or could not take oral iron treatment. The PDUFA date is October 21, 2013.
10/21/2013 CBST Cubist Pharmaceuticals Y PDUFA (sNDA) Entereg GI recovery On December 21, 2012 Cubist announced that it submitted an sNDA to the FDA requesting approval for the use of ENTEREG (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease. The estimated PDUFA date is October 21, 2013.
11/4/2013 BIIB Biogen Idec Y PDUFA (BLA) Alprolix Hemophilia B On March 4, 2013 the FDA accepted Biogen's BLA for the marketing approval of ALPROLIX (recombinant factor IX Fc fusion protein, or rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. The expected PDUFA date is November 4, 2013.
11/11/2013 BIIB Biogen Idec Y PDUFA (sNDA) Tysabri Multiple sclerosis On January 16, 2013 Biogen Idec and Elan submitted an application to the FDA requesting updates to the TYSABRI (natalizumab) labels. The application requests an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis who have tested negative for antibodies to the JC virus. Biogen completed a purchase of full rights and control of TYSABRI from Elan on April 2, 2013. The expected PDUFA date is November 11, 2013.
11/27/2013 BMY / AZN Bristol-Myers Squibb, AstraZeneca Y PDUFA (BLA) Metreleptin Metabolic disorders associated with lipodystrophy On June 4, 2013 the FDA accepted and granted a Priority Review designation for the Biologics License Application (BLA) for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy (LD). The expected PDUFA date is November 27, 2013.
By 11/28/2013 (estimated) SNY Sanofi Y PDUFA (sBLA) Lemtraded Relapsing multiple sclerosis On January 28, 2013 the FDA accepted for review Genzyme's sBLA seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis. Genzyme is a Sanofi company. The company said it expects FDA action in late 2013.
-- Tyler Desmond
DGLY came out with some good quarterly earnings. News release is very positive, but I'm not sure how well we can expect it to do going forward.
Anybody have an opinion one way or the other on DGLY?
LENEXA, KS--(Marketwired - Jul 23, 2013) - Digital Ally, Inc. (NASDAQ: DGLY), which develops, manufactures and markets advanced video surveillance products for law enforcement, homeland security and commercial applications, today announced its operating results for the second quarter and first half of 2013. An investor conference call is scheduled for 2:15 p.m. EDT tomorrow, July 24, 2013 (see details below).
Second Quarter Highlights
Total revenue increased 10% to $5.1 million, compared with total revenue of $4.6 million in the second quarter of 2012.
Gross profit margin improved to 60.1% of revenue vs. 53.8% in prior-year period.
General and administrative expenses declined 6% from year-earlier levels.
The Company reported an operating loss of ($21,239), which represented an improvement of $854,291 when compared with an operating loss of ($875,530) in the second quarter of 2012.
The Company reduced its net loss by 93% to ($67,151), or ($0.03) per diluted share, compared with a year-earlier net loss of ($949,201), or ($0.47) per share.
Non-GAAP adjusted net income improved to $306,462, or $0.15 per diluted share, versus non-GAAP adjusted net income of $79,411, or $0.04 per diluted share, in the prior-year quarter.
The Company was notified in July 2013 that the U.S. Patent Office has allowed two patent applications for the Company's Digital Video Mirror ("DVM") product offerings and related transmitters that are used by law enforcement personnel in the field.
Six-Month Highlights
Total revenue increased 17% to $9.8 million, versus total revenue of $8.4 million in the first half of 2012.
Gross profit margin widened to 60.3% of revenue, compared with 53.3% in corresponding period of previous year.
General and administrative expenses were 10% lower than in prior-year period.
An operating profit of $160,178 compared with an operating loss of ($1,607,710) in the six months ended June 30, 2012.
Net income improved by $1.8 million to $46,544, or $0.02 per diluted share, in the first half of 2013, compared with a net loss of ($1,753,930), or ($0.87) per share, in the first half of 2012.
Non-GAAP adjusted net income improved to $700,014, or $0.33 per diluted share, versus a non-GAAP adjusted net loss of ($335,261), or ($0.17) per share, in the year-earlier period.
Full text at:
http://finance.yahoo.com/news/digital-ally-inc-announces-second-201500553.html
On a fundamental basis it would seem to require a few handfuls of new ApneaRX equipment rental contracts and a few new Encore staffing offices.
Execution by management and Honest Discussion about the outlook for improving business metrics (revenues, profitability, P/E, etc., like you have mentioned before) is what this company needs if it is to grow its investor base (add buyers to the mix).
Currently, and over the last two years, SHOM appears to have gotten stuck in a situation where the staff gets paid, so the company is stable, but there is nothing obviously going on that will build momentum and increase cashflow and profitability.
MMT - interesting trading...
According to gulo19 on IV
http://premium.investorvillage.com/groups.asp?mb=17397&mn=15358&pt=msg&mid=12957396
Cormark (73) buying and selling to and from Anon(01), almost exclusively ... in large quantity ....
MyComment: Nothing ominous, just a Canadian broker arranging a few large sales internally or with another broker.
Actually I relax much better after a good gripe!
As for your $3 prediction, they'd have gotten there by end of 2013 if all the planned catalysts had been executed according to plan. We can disagree about why some milestones have been delayed, but the result is that the lengthy delays have hurt us common stockholders, while management pockets more cheap options.
Yes, $3 (in late 2013, or even late 2014) would be nice. Then I can really relax.
Salutations, all!
'peeker
Of course not. Management would not allow anything to get in the way of a meeting that was required to approve more management options.
While I am disappointed at Mart's busted timelines and the atrocious ongoing pipeline losses via Agip, I am not selling here; I have learned through experience that it is pragmatic to double all time durations and milestones provided by management.
Mart's portion of that would be about half, further reduced by 15% pipeline losses (probably 12-16%), so monthly revenues are closer to maybe $14 million, wouldn't you guess?
Mart's timelines have been seriously busted for awhile now, and they are basically dependent on partners and Agip for any increase in drilling activity and production. Of course the board was motivated enough to attend the AGM in the middle of a flood in Calgary since the annual management options awards required a vote.
Crap! Poor monthly production again . . . . May pipeline losses should be known by now, and they still cannot even be bothered to announce status of UMU-11 drilling? Where is Mart management vacationing this month?
Very OT: Yes, if you plant Hostas around the sign.
Plant them, and they will come.
Warning: Do not plant the Hostas near the graves of Texas Republican legislators, as multiple species will arrive to Pee on the graves, also killing the Hostas.
PTO.to/PTQMF exhibiting strength today on above avg volume. Not sure where the interest is coming from, but there have been some nice buys, especially in the last hour.
I own PTQMF and believe it is undervalued, especially since I'm down 40% on it....
Any ideas as to what is driving PTQ higher would be appreciated!
Regards,
'peeker
My notes from Mart's AGM today:
Wade's Totally Excellent AGM Adventure
Did not attend, but I listened to the AGM via phone and was verrrrry impressed with Wade's mastery of the story, maybe because he's been saying much the same thing for the last year. My sarcasm aside, I thought Wade did a masterful job of explaining plans for increasing Mart's value, and I do not intend to sell a single share until we are significantly higher.
Pipeline capacity constraints from the Umusadege field have continued to be the greatest limiting factor for Mart's growth. Wade would like to partner on multiple fields, not just Umusadege, to diversify production and get away from the severe dependence on Agip. Pipeline losses were about 13-14% for Agip pipeline to Brass terminal in 2012 vs. about 8-9% for Shell pipeline to Forcados line. If UMU partners get switched over to using Shell, that will actually increase their reserve computations because reserves must deduct for expected/experienced pipeline losses.
New pipeline progressing and should be done later this year. Crude Sales Agreement with Shell was signed long ago. Crude Handling Agreement needs to be agreed by NPDC (government) and Heritage Oil; he sees no problem, just waiting for the bureaucracy to do its magic.
Pioneer status ends this year but they have tax pools (due field development expenses) accrued that will reduce taxes into 2014. My comment: Although the tax pools help, Mart still missed the opportunity to ramp production in 2013 while Pioneer status taxes were verrrry low.
Regarding stock price, Wade mentioned rightly that all oil stocks have been whacked, most more than Mart. The Agip pipeline problems did significant damage to the stock price. Mart is working on Toronto listing, to be followed by London listing. They are currently in process of filing an AIF, whatever the heck that is, which should facilitate the Toronto listing.
He and the CFO are continuing to try to get the story out to analysts, and he expects rerating (improvement) of Mart's stock value as the plans for the future unfold.
Catalysts for improving the stock price would include:
1. the new pipeline comes online this year. My comment: cough, cough,
2. UMU-11 and UMU-10 completion should increase production capability to 22-23,000 bopd,
3. new rig (contract to be awarded soon) for drilling up to three horizontals this year to increase total production to the 35,000bopd capacity of their central processing facility (inspection due 7 July, so that capacity will be there as new production comes online). Three horizontal wells will include reentry of UMU-3 and UMU-4 and one totally new horizontal well. My comment: With completion of UMU-10, UMU-11, and the 3 horizontals, we should see Umusadege producing up to the 35,000 bopd.
4. exploration wells should add significantly to total Umusadege field reserves (expects to drill exploratory wells in eastern extension immediately following UMU-11 and completion of UMU-10). Exploration program will eventually include probably 4-5 wells on eastern extension and 4-5 wells on western extension with the drilling pace being driven by production successes and further increases in pipeline capacity. Expectation is that UMU partners will continue to deliver to market thru Agip and Shell as production increases over time. My comment: This will probably take all of 2014 and 2015, but the result could be a great increase to production and reserves over these next two years.
5. partnering with additional indigenous companies on new marginal fields and additional properties divested by major oils.
6. large 2014 and 2015 cashflow increases become apparent.
My comment: Catalyst has been much-used over the last year to describe the above items. We stockholders want to see these catalysts turned into ACCMPLISHMENTS.
Asked about buyouts and mergers, Wade says he and the board will consider all offers, but there are currently no offers to consider. Asked about benefits of merging to become an indigenous company vs. remaining standalone and partnering with multiple indigenous companies, Wade indicated that the big advantages are with indigenous companies (Only indigenous companies can bid on new marginal field round, can buy other properties as large majors divest some of their land holdings). My comments: I interpret his comments to mean that he still wants to merge with an indigenous company, most probably Midwestern. It will certainly be interesting to see whether Mart really does partner with indigenous companies (in addition to Midwestern) on Marginal Field bids and on bids for other properties that large majors (Shell, Conoco, etc.) are divesting.
Wade again described the importance of working closely with the local communities to maintain good relations all around, including plans to provide power to local communities as they generate power for local communities (rather than flaring gas) from their processing facilities. My comment: It's hard to really understand what goes on in Nigeria, but one gets the sense that Wade is genuinely interested in Mart's being a positive influence in the areas that they operate. It sounds like he doesn't want to harm the environment or the local communities. He likes that they hire local contractors and support the local communities. I find that commendable.
He was positive about govt efforts to reduce bunkering (and therefore, pipeline losses), but mentioned that it must be accomplished in a balanced way, that is, you cannot just send in thousands of troops without the local communities responding very negatively. Govt has been dismantling some illegal refineries and is looking at things like putting tracers in the oil to track stolen oil and also looking at ways to monitor the pipelines more closely. My comment: Who knows, maybe pipeline losses can be reduced over the next few years rather than continuing to increase.
Asked about dividend vs. stock buybacks, he reiterated that the dividends have been well received, and as cashflow improves in future, increasing the dividend seems like a better approach than stock buybacks.
My last comment: I was very impressed with Wade's presentation, and I am hopeful that progress will come faster in the next year than it did in the last year. I mean, since last year's AGM they accomplished at least 3 months worth of work in less than a year.
Be well!
'peeker
Oh really, Soothsayer?
W H Y ???
Due to crystal ball cloudiness, I have trouble seeing the catalyst for Mart's next big run. They've lost a lot of momentum this year due to Agip pipeline problems, and the new pipeline and new wells have been delayed, so they cannot ramp up to big production before Pioneer tax status runs out.
Though I own a lot of the stock, I see challenges, lots of big challenges.
12:09 VVUS
Vivus: Spike being attributed to Leerink note suggesting a bipartisan group of lawmakers will introduce a bill to allow Medicare to cover weigh loss (14.19 +0.43)
Secondaries include: ARNA, OREX.
08:33 RFIL
RF Industries reports Q2 EPS of $0.14 vs. $0.08 last year; rev +37% to $9.2 mln (no ests) (7.11)
AMBA ($16.17)THE NEXT BIG THING | Updated: 04-Jun-13 |
Ambarella (AMBA) Earnings Preview:Quality Fundamentals & Track Record of Beats, But Risks Still High
After the close tonight, Ambarella (AMBA) is scheduled to release its fiscal Q1 results with a conference call to follow at 5:00 pm ET. Following its dreadful pricing on October 10, 2012 ($6 vs. $9-$11), AMBA has dramatically turned the tables to become one of the top-performing IPOs of the past year, up 160% versus its IPO price. Its success and strong growth has largely been fueled by the growing popularity of wearable sports cameras -- namely, the "GoPro" camera -- in which its semiconductors enable high-end HD video capture. More recently, however, it has gained traction in auto and video security industries, especially in emerging Asian Pacific markets. With this momentum behind it, AMBA surpassed analysts' expectations in its first two quarterly reports, which has also propelled the stock higher.
For tonight, it will need another upside report to keep the momentum going, and as we discuss below, the table may be set for it to do just that. We continue to like the stock heading into the print tonight from a fundamental perspective, but the risks are high. Given how this stock tends to move rapidly, investors and traders could be in for a wild ride. A miss would likely send the stock tumbling lower in short order, and vice versa.
Whats Expected
For its fiscal Q1, AMBA is expected to report EPS of $0.13 on revenue of $31.89 million, which would represent year/year topline growth of 23%. This is one of its seasonally softer quarters, with fiscal Q3 being the strongest ahead of the holiday season.
During its Q4 conference call, it guided for Q1 revenue of $31-$33 million, of which about 84% will be derived from camera-related products -- a big jump from the 67% in the year-ago period. Recall that in its Infrastructure segment, AMBA also develops chips and technology that is used in television broadcasting. As AMBA continues to focus on varying camera markets (wearable sports, automotive, security), this business has steadily declined as a percentage of revenue.
During its Q4 call, AMBA also guided for Non-GAAP net income of $3.5-$5.0 million, with fully diluted shares outstanding of 28.7 million. This would pencil out to an EPS range of $0.12-$0.17, or about $0.15 at the mid-point. It is interesting that the Street's EPS estimate is at the low-end of its Q1 guidance, especially since it beat the EPS number by $0.06 in Q3 and $0.05 in Q4. This could simply be a case of analysts setting a low bar to hurdle, and could set up well for AMBA again beating EPS estimates.
Those that follow AMBA realize that its gross margin has been declining, but this is basically by design, and is a function of its strategy to focus on building its camera-related business. The trade-off is to build on its market leading position in a fast growing wearable sports market and gain traction in auto and security markets overseas, at the expense of its gross margin falling from about the 70% levels in 2011 to the current low-to-mid 60% range. Last quarter, gross margin came in at 63.3%.
In regards to guidance, AMBA will likely provide Q2 revenue guidance during the call, and perhaps Q2 Non-GAAP net income guidance as well. For Q2, analysts currently are forecasting revenue of $34.72 million, equating to year/year growth of 24%, consistent with its recent topline growth rates.
Recent Earnings History
Since going public, AMBA has reported earnings twice, and on both occasions, it topped the EPS and revenue expectations. Its initial report came on December 5 when it reported EPS of $0.31, good for a six cent beat, with revenue up 24% year/year to $35.7 million versus the $34.3 million consensus. The stock was pretty volatile the following day, swinging from a high of $9.58 to a low of $8.60, ultimately closing at $9.08, up 1% for the day. Although the report didn't immediately cause a strong upward reaction in the stock, it did spark a run over the next month or so, with AMBA gaining nearly 50%.
Following its Q4 report, the stock did have a much more pronounced reaction, as the name was more familiar to traders and investors by this time. Its strong Q4 report also solidified it as a legitimate growth story in the eyes of more traders. Specifically, EPS came in at $0.18, five cents better than the $0.13 estimate, as revenue rose 28% to $31.5 million vs. the $29.2 million consensus. What was especially impressive was that its revenue growth rate was its best performance in recent history (1Q12: +20% ... 2Q12: +26% ... 3Q12: +24% ... 4Q12: +28%).
AMBA also issued upside Q2 revenue during its conference call and net income guidance that suggested upside EPS guidance as well. Following the beat-and-raise quarter, AMBA shares gapped higher at the open on March 8, shooting higher by 14% on the day.
Key Topics
When discussing AMBA, the topic that frequently comes up is its exposure to the wearable sports camera markets -- in particular, its leading position in the market via its placement in the popular GoPro wearable cameras. Without question, this has been a major catalyst for its business and its stock. And, it is looking to build upon its strong hold on the market through new product introductions. During the Q4 conference call, management spoke about how its chips are now included in iON's "The Game" action camera, which features W-Fi connectivity and the camera enables hands-free, remote recording of activity. So, the wearable sports camera market figures to remain its "bread and butter" for the time being.
With that said, AMBA is clearly making a concerted effort to diversify into other verticals. In fact, during its Q4 call, AMBA seemed to spend more time discussing its activities in the IP security and automotive markets. For the IP security market, AMBA stated that these products were a significant driver of revenue growth and stronger-than-expected gross margin in FY13, driven mainly by strong demand in China. Expanding in China will be a core strategy going forward as that country continues to migrate away from standard analog definition to digital IP-based high def cameras.
Automotive is the other key growth driver. In this market, AMBA provides chips for windshield-mounted camera recorders. This is a particularly strong market in countries such as China, Korea, Taiwan, and Russia. This is an area where AMBA sees a lot of potential because the overall market is growing rapidly and customers are migrating from standard definition to high-definition products.
Considering that AMBA's exposure to the wearable sports camera market is already fairly well known and understood, we would again expect it to spend a majority of time going over what it sees as its next growth catalysts: namely, IP security and automotive, in emerging economies.
Conclusion
AMBA's Q1 is one of its seasonally slower quarters, so its sequential revenue growth rate isn't going to look overly impressive (inline would be +1%). However, its revenue growth on a year/year basis continues to be remarkably consistent, in the mid-20%, as we pointed out above in the "Recent Earnings History" section. Furthermore, analysts' Q1 expectations may set up nicely for AMBA. Current consensus for revenue of $31.89 million is slightly below the mid-point of AMBA's guidance of $31-$33 million, and last quarter, AMBA topped its own revenue guidance, reporting revs of $31.5 million vs. its $28-$30 million projection. And, for EPS, the current EPS estimate of $0.13 also sits at the low-end of AMBA's indicated EPS guidance of $0.12-$0.17.
With AMBA issuing upside reports in each of its first two quarterly reports, traders and investors are likely expecting more of the same this time around, so, an inline or worse report will be viewed as a disappointment. Given that the stock is up 35% since it last reported, and given how volatile this stock can be at times, a miss would likely result in a very sharp downward reaction. So, while its topline consistency, positive track record vs. estimates, and a reasonable bar to hurdle in Q1 all make the odds of a beat look solid, taking a position ahead of its earnings report is still a risky proposition and not for the feint of heart.
But, simply put, AMBA continues to be one of our favorite recent IPOs. It offers an attractive balance of growth at a reasonable price. As its Q1 report approaches, the stock is trading with a 1-year forward EV/Sales below 2x and a 1-year forward P/E of 15x. For this fiscal year, revenue is expected to grow by 20%. In FY14, revenue and EPS are expected to grow by 20% and 32%, respectively. It already has a dominant position in the wearable sports camera market, and is finding new, fast growing venues for its video processors.
Trading Strategy: To wrap up, we continue to like AMBA as an investment and a holding. It depends on your risk tolerance as to whether entering a new position directly ahead of earnings is suitable. Remember, AMBA can be an extremely whippy stock. The initial knee-jerk reaction to the print could be severe in either direction. Even if AMBA does provide a beat, the stock could be prone to a "sell the news" reaction. Furthermore, the broader market is on shakier ground right now, with small caps taking the brunt of any weakness. There is just much more risk heading into the print, as compared to say LifeLock (LOCK), back when we profiled it on May 1 ahead of its earnings. Therefore, for investors considering a new position in AMBA, it may be more prudent to take a "wait and see" approach, and let the volatility play out before entering a trade. This could take some of the upside out of the equation, but, being a little more cautious here seems like a better way to approach it this time around.
PPHM: Peregrine Pharma Trades 12.5% Higher Following Positive Bavituximab News
Peregrine Pharma ($1.65) reports data presented at ASCO shows promising 11.7 month median overall survival in second-line NSCLC patients treated with co's novel immunotherapy bavituximab.
The company reported final data from its randomized, double-blind, placebo-controlled Phase II trial of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). Final results from the Phase II trial showed an improvement in median overall survival (OS) of 11.7 months in the 3 mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the combined control arm, with a persistent separation in the Kaplan Meier survival curves (HR=0.662).
In addition, subgroup analyses of overall survival by key patient characteristics favored the bavituximab 3 mg/kg arm, including age, gender, ECOG status, ethnicity and prior treatment. The results also indicated that the 3 mg/kg bavituximab plus docetaxel combination was well-tolerated with no significant differences in adverse events between the trial arms. These results were presented Saturday at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Staar Surgical (STAA): Sounds pretty confident that implantable lenses can replace LASIK surgery
Staar Surgical (STAA), which makes implantable lenses for the eye and which was recently re-added to our Emerging Growth rankings (added May 7 at $8.99), just wrapped up its presentation at the Deutsche Bank Healthcare Conference in Boston. It sounds like its biggest competitor (LASIK surgery) is on the decline and Staar is filling the void. Since Staar is not a well known name in the US (81% of 2012 revenue was from outside the US), we wanted to provide some highlights from the presentation.
In terms of what Staar does, they make implantable lenses for the eye both to correct vision (Visian ICL lens, which is an alternative to LASIK surgery) and to treat cataracts (IOLs). All of its lenses are foldable and can be inserted through a small incision in the eye. It's basically an implantable contact lens. STAA believes its Visian ICL lens is better than LASIK as it has better results, fewer side effects and, unlike LASIK, can be removed if the patient is not satisfied. That's a big selling point to nervous consumers. Management believes its competitive position has improved over the past six months as it appears LASIK procedures are declining in major markets. Also, lenses which are in the anterior segment of the eye all seem to be facing new clinical challenges. The Visian ICL sits behind the iris in the posterior segment. As a result, STAA believes it is taking market share. The stock jumped in early May on a surprisingly strong Q1 report and the favorable comments about its improved competitive positioning.
Probably the most interesting point to come out of today's presentation is STAA being pretty confident that LASIK surgery is on the decline. Basically, they said that there are always evolutions in healthcare. In this space, it was originally glasses then contact lenses etc. "There is clear evidence that LASIK is on the downturn and there is evidence that ICL is taking over. This is the moment for the ICL." LASIK and the related complications have seen a good deal of negative press over the past few years. While this is good for Staar, which has a competing product, unfortunately this tends to weigh down the entire elective eye surgery market as consumers lump all of them together. In particular, there has been a lot of negative press about LASIK in China over the past year. This hurt STAA's results in this important region but they have seen some improvement recently.
In terms of the R&D pipeline, STAA has regularly introduced new products over the past few years. Perhaps most importantly, STAA introduced the ICL V4c with CentraFLOW technology in Europe and other territories in 2011. The CentraFLOW technology optimizes the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant. By simplifying the procedure to a one-time visit like LASIK, STAA is much better able to compete with LASIK. STAA expects to get approval in India and Korea for the CentraFLOW technology. In the first year after approval in Europe it had a big impact on STAA's results and they expect a similar impact in other countries. Another key launch was the Toric ICL in Japan to treat patients primarily affected by astigmatism.
A big reason STAA is not well known in the US is because its two most advanced lenses are not yet approved in the US. In particular, management concedes that the Toric not being approved in US has been a cloud over the company. STAA has shown it can do well outside of the US but cracking the US market in a bigger way would be a big positive. STAA has filed its application and has had dialogue with the FDA. STAA has been pushing that it would like some sort of decision this year (either approval, go to panel, not approved). Overall, STAA says he has felt a change at the agency that the process seems to finally be moving along.
In terms of other topics, STAA is moving its manufacturing operations from Japan and Switzerland to the US. This manufacturing consolidation should improve gross margins further. The process is wrapping up this year and it's on plan. This is a major project and gross margins should get near 80% after the consolidation. Another topic was STAA's heavy investment in sales/marketing last year. They expect to start to see some benefit this year. They also have some key new product launches and approvals coming up in 2013. Also, Spain has been converted to a direct model (instead of using distributors) which will help margins. Finally, STAA says it wants to crack the US market in a bigger way as it's an attractive opportunity but they do not expect much additional penetration until the Toric ICL gets approved.
Overall, we remain a fan of STAA. They seem confident that LASIK surgery is on the way out and the implantable lens is the next step in corrective vision technology. A huge selling point is that the lens can be removed if the patient is not happy. The unfortunate part about the STAA story is that its latest technology is not yet approved in the US, it's mostly being used in Asia and Europe. But they are working on that and if they get approval, that would be a big boost for them. Another recent development in its favor, we believe, is the recent announced acquisition of lens supplier Bausch & Lomb by Valeant Pharma (VRX). STAA is tiny but has some attractive technology that we think would be attractive to a larger player in this space.
OT: (ACRX) No, but it will reduce the kicking, screaming, and crying.
They did post a very good presentation on their nanotab pain management system at today's UBS Global Healthcare Conference.
http://ir.acelrx.com/phoenix.zhtml?p=irol-eventDetails&c=241441&eventID=4966698
09:01 ACRX (from Briefing.com)
AcelRx: Canaccord Genuity reviews this morning's clinical results announcement; NDA remains on track (6.40)
Canaccord notes ACRX reported that it has achieved its primary endpoint (SPID-48) for its placebo-controlled Phase 3 study in major orthopedic surgery (knee or hip replacement) for its sublingual Sufentanil NanoTab PCA System. This is the third (of a total of three) Phase 3 studies the Co has completed, and NDA submission remains on track for Q3 2013. Firm continues to see an attractive market opportunity for ARX-01 in the hospital setting, with un-risk adjusted peak sales of $577 mln in 2022. The study enrolled 426 adult patients at 34 US sites and showed a significantly greater SPID-48 versus placebo-treated patients (+76.1 vs -11.5, p<0.001) while also hitting secondary endpoints.
OT: WFC appears to have consciously decided to "take" the (voiceless) little guy when he screws up and overpays his bills (w/o cash to cover). WFC decided on processes to generate higher total overdraft fees; they wanted the big payments (like credit card bills and home mortgages) to go thru rather than small drafts for 64oz Big Gulps at the 7-11 store. Remember the decision they made was to pay the bigger debits first rather than abide what they had previously said they would do, that is, to pay them in chronological order.
Forrest Gump would say, "A Stinker is what a Stinker does!".
I wouldn't say this, but kozuh would say, "Don't be a stinker, Bob."
As for choosing process, yes, you are right, and having done a little work at SunTrust Bank for a brief time, it's obvious that dealing with transaction processes methodically is hard enough, especially when everything seems to run in overnight "batch" mode.
To be truthful, I'm much more concerned with things like UMU-11 delays and stock price slide, which may be the only cause of my foul mood about WFC lawsuits.
Regards,
'peeker
ps> You are no longer living in the banker's suite, so you really needn't defend them anymore... Afterall, the bankers get lots of advantages that us mere mortals could never imagine.
WFC: I may just have to close my Wells Fargo checking acct after reading that these weasels did something as despicable as this:
17:58 Wells Fargo: Lieff Cabraser Heimann & Bernstein, LLP announce Federal Court reinstates $203 mln judgement against Wells Fargo (39.30 +0.54)
Michael W. Sobol of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that U.S. District Judge William Alsup late yesterday afternoon issued an order to reinstate a $203 million judgment against Wells Fargo Bank (WFC). The judgment is based upon the court's findings, as affirmed on appeal by the Ninth Circuit, that Wells Fargo violated California's unfair competition law by deceiving its customers that debit card purchases would be posted chronologically to their accounts when in fact Wells Fargo posted them in a high-to-low order for the sole purpose of generating overdraft fees.
MMT.v April production does seem to cover about half of the repayment to Agip for "deficit oil", that is, the oil they have been paid for which was never delivered due to pipeline shutdown mid-Feb thru mid-April. I'm just hoping not too much of it squirted out of the pipeline (due bunkering) enroute to Agip's terminal. Mart gets credit for the oil that makes it to the terminal, not for all the oil they put into the pipe.
Mart still has a lot of work to catch up on now that they are back into full production, particularly they need to drill the horizontal from old UMU-3, drill UMU-11, and complete UMU-10.
OK, Mart, let's get a move on!
Link to the BCC-Conoco deal. It looks like Buccaneer really needs to raise the cash to drill a couple of deep wells now.
http://www.proactiveinvestors.com.au/companies/news/42901/buccaneer-energy-to-earn-100-working-interest-in-conocophillips-deep-oil-rights-in-alaska-42901.html
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Buccaneer Energy to earn 100% working interest in ConocoPhillips' deep oil rights in Alaska
Monday, May 06, 2013 by Proactive Investors
Buccaneer Energy (ASX:BCC) has inked a deal with U.S super major ConocoPhillips (NYSE:COP) whereby it will have the right to earn a 100% working interest in Conoco's deep oil rights in 23,368 acres in North Cook Inlet in Alaska.
As part of the transaction, Buccaneer has also entered into a licence agreement on the existing 3D seismic owned by ConocoPhillips. The 3D licence covers both the area subject to the deep oil rights agreement as well as the existing North West Cook Inlet Unit.
Buccaneer has agreed to the division of the farm-in area into two acreage blocks--Block A and Block B-- with a well commitment in each.
A well must be spudded in either Block A or Block B by December 31, 2014 and a second well in the other block by December 31, 2015.
The company plans to spud the first well in the Southern Block A to test the Hemlock Formation using the Endeavour jack up rig.
This well will be an offset to the ARCO North Forelands-1 well that was flow tested at 4,343 BOEPD from three formations (including the Hemlock) and was drilled when oil averaged US$19.25 per barrel.
Buccaneer will not pay any upfront cash for the transaction and Conoco will retain all the shallow gas rights as well an overriding royalty interest.
The oil is contained in the Lower Tyonek, Hemlock, Sunfish and West Foreland Formations and since 1962, these formations have been penetrated by 13 wells, of which 10 wells have been successfully flow tested at rates of up to 4.343 barrels of oil equivalent per day.
Buccaneer has commissioned Netherland, Sewell and Associates to provide a reserve report on the oil reserves acquired by the company and is likely to book significant 2P reserves.
Netherland, Sewell had assigned a P50 resource of 15.5 million barrels of oil and 187.2 Bcf of gas to Buccaneer's wholly owned North West Cook Inlet Unit that has the same geological structure as the leases being farmed into by the company.
The company is on the market to raise up to $36.46 million via a rights issue on a 3 for 5 basis at an issue price of $0.04 per share.
It had a cash balance of A$5.27 million at the end of March 2013 quarter.