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ADY Never ran yet in China space & 1/3rd net tangible assets after debt & at 1/5th price to sales with current 2012 P/E of 3 could & should get jiggy especially with Press release coming soon stating that Sequoia Capital is Fully repaid 65 million dollars in cash ....
ADY Mkt Cap 60 Mill $$$
ADY got hammered last year $10 to $2's cause EVERYONE thought they would/could never pay Sequoia Capitial the 65 Mill $$$ in debt, ALL thought ADY as all China's would convert the debt into shares at $3 or 22 Mill New Shares YIKES !!!! Didn't happen. Now that this forgotten Co is left for dead read Alfred Littles take on ADY & coming true exactly as he called it
http://seekingalpha.com/article/288467-feihe-international-rapidly-improving-balance-sheet-growing-market-share-and-strong-earnings
remember share count lowered to 19 mill from 21.4 mill as ADY elected to buyback preferred shares instead of letting 65 Mill $$$ worth convert at $3 a share. Tell me 1 China smallcap that has done this ??? ALL would have let them convert instead of coughing up 65 mill $$$ in Cash to Sequioa Capital.
Another Rare event ADY sold dairy farms for 133 mill $$$ UNLIKE every small cap chiscam buying over priced land or buildings or factories or other business that have little or no value.
ADY has Net Tangible Assets after Debt of $9.33 a share & tiny Mkt Cap of 60 Mill $$$ compare with sector peer SYUT at 340 Mill $$$ Mkt Cap even though they both have similar sales & earnings BUT SYUT has tons more debt & $154 a share Net Book Value....
Float is very small approx 9 mill shares as Insiders own almost 10 mill Shares...
Infant formula & milk is one of the highest regulated biz in China thus reducing fraud chance to nill & ADY celebrating it's 50th year in biz.
ADY the only China infant formula co. doing clinical research trials being conducted by china Govt & had stellar results.Also of note ADY 1 of the Only China milk co.s NOT involved in any way of the Melamine debacle of 2008 & has never had any quality issues.
Pull up a 5 Year Chart ADY was NEVER under $6 a share till a few months ago then look at Vol that dropped it from $8.70 to $2's ??? Low to No Vol every day no mill share days
Cash flow from operations in 2011 was Positive 87 million dollars & reduced their debt from 147 Million dollars in Dec 2010 to currently 82 million dollars reducing debt by almost 66 MILLION $$$$. Also please note Sequoia will be 100% paid off this month = total repayment of 65 million dollars certainly not the mark of a co. going BK lol....
Couple of other quick points ADY still will receive another 101 Million Dollars over the next 5 Quarters from farm sale & will most likely be completely Debt Free by Years end.
ADY's line of credit is for 111 Million Dollars with 31 Million used & 80 Million Dollars in Unused credit & BTW Interest rates are Tier 1 rates at 5.8% to 6.2% very low for China .
As far as other assets they could sell if needed would be one of their multiple newer updated GMP compliant production facilities which imo they wont sell as they have no need to but could...
While I agree there are some negatives on ADY like the quality of their earnings & relying on Govt subsides the bottom line is their Premium Astrobaby formula is gaining real traction & becoming a higher % of sales every Qtr enhancing margins nicely. Avg selling prices for ADY formula thanks to Astrobaby line rose from $7.94 per kilo to $10.57 per kilo 33% Increase YOY....
ADY is trading over $6.00 per share below Net Tangible Assets after Debt valuation & when compared to SYUT ( 340 Mill Mkt Cap ) one does have to wonder is SYUT severely overvalued or is ADY ( 61 Mill Mkt Cap ) severely undervalued ??? Time will tell...
couldn't buy junk fast enough ADY though moved 15% that's it CREG CLNT THTI GPRC NFEC all nice $$$$ winners for me
China space like crazy town last few days hope many made $$$$$$$$$$
ADY catching Vol & price .
ADY ADY Mkt Cap 60 Mill $$$ remember share count lowered to 19 mill from 21.4 mill as ADY elected to buyback preferred shares instead of letting 65 Mill $$$ worth convert at $3 a share. Tell me 1 China smallcap that has done this ??? ALL would have let them convert instead of coughing up 65 mill $$$ in Cash to Sequioa Capital.
Another Rare event ADY sold dairy farms for 133 mill $$$ UNLIKE every small cap chiscam buying over priced land or buildings or factories or other business that have little or no value.
ADY has Net Tangible Assets after Debt of $9.33 a share & tiny Mkt Cap of 60 Mill $$$ compare with sector peer SYUT at 340 Mill $$$ Mkt Cap even though they both have similar sales & earnings BUT SYUT has tons more debt & $154 a share Net Book Value....
Float is very small approx 9 mill shares as Insiders own almost 10 mill Shares...
Infant formula & milk is one of the highest regulated biz in China thus reducing fraud chance to nill & ADY celebrating it's 50th year in biz.
ADY the only China infant formula co. doing clinical research trials being conducted by china Govt & had stellar results.Also of note ADY 1 of the Only China milk co.s NOT involved in any way of the Melamine debacle of 2008 & has never had any quality issues.
Pull up a 5 Year Chart ADY was NEVER under $6 a share till a few months ago then look at Vol that dropped it from $8.70 to $2's ??? Low to No Vol every day no mill share days
Cash flow from operations in 2011 was Positive 87 million dollars & reduced their debt from 147 Million dollars in Dec 2010 to currently 82 million dollars reducing debt by almost 66 MILLION $$$$. Also please note Sequoia will be 100% paid off this month = total repayment of 65 million dollars certainly not the mark of a co. going BK lol....
Couple of other quick points ADY still will receive another 101 Million Dollars over the next 5 Quarters from farm sale & will most likely be completely Debt Free by Years end.
ADY's line of credit is for 111 Million Dollars with 31 Million used & 80 Million Dollars in Unused credit & BTW Interest rates are Tier 1 rates at 5.8% to 6.2% very low for China .
As far as other assets they could sell if needed would be one of their multiple newer updated GMP compliant production facilities which imo they wont sell as they have no need to but could...
While I agree there are some negatives on ADY like the quality of their earnings & relying on Govt subsides the bottom line is their Premium Astrobaby formula is gaining real traction & becoming a higher % of sales every Qtr enhancing margins nicely. Avg selling prices for ADY formula thanks to Astrobaby line rose from $7.94 per kilo to $10.57 per kilo 33% Increase YOY....
ADY is trading over $6.00 per share below Net Tangible Assets after Debt valuation & when compared to SYUT ( 340 Mill Mkt Cap ) one does have to wonder is SYUT severely overvalued or is ADY ( 61 Mill Mkt Cap ) severely undervalued ??? Time will tell...
ADY DD & Reported sales of 87 Mill $$$ this A.M. vs 71 mill EST had several 1 time charges in report causing a loss instead of positive net income. Missing Govt & Tax subsides that s/b rolling into 1rst quarter. Bottom line here is a DD list on ADY & why I still think this co. has a stellar chance of being a double/Triple in the weeks & months ahead...
ADY Mkt Cap 60 Mill $$$ remember share count lowered to 19 mill from 21.4 mill as ADY elected to buyback preferred shares instead of letting 65 Mill $$$ worth convert at $3 a share. Tell me 1 China smallcap that has done this ??? ALL would have let them convert instead of coughing up 65 mill $$$ in Cash to Sequioa Capital.
Another Rare event ADY sold dairy farms for 133 mill $$$ UNLIKE every small cap chiscam buying over priced land or buildings or factories or other business that have little or no value.
ADY has Net Tangible Assets after Debt of $9.33 a share & tiny Mkt Cap of 60 Mill $$$ compare with sector peer SYUT at 340 Mill $$$ Mkt Cap even though they both have similar sales & earnings BUT SYUT has tons more debt & $1.54 a share Net Book Value....
Float is very small approx 9 mill shares as Insiders own almost 10 mill Shares...
Infant formula & milk is one of the highest regulated biz in China thus reducing fraud chance to nill & ADY celebrating it's 50th year in biz.
Will be debt free by years end as ADY has 4 more qtr's of receiving 19 Mill $$$ per Qtr from farm sales & still has approx 20% of production facilities that if needed could sell but I doubt they will as plans to grow into extra capacity.
ADY the only China infant formula co. doing clinical research trials being conducted by china Govt & had stellar results.Also of note ADY 1 of the Only China milk co.s NOT involved in any way of the Melamine debacle of 2008 & has never had any quality issues.
Pull up a 5 Year Chart ADY was NEVER under $6 a share till a few months ago then look at Vol that dropped it from $8.70 to $2's ??? Low to No Vol every day no mill share days
Some links
http://seekingalpha.com/article/288467-feihe-international-rapidly-improving-balance-sheet-growing-market-share-and-strong-earnings
http://ady.irpage.net/details.php?id=47460
http://ady.irpage.net/details.php?id=48171
http://ady.irpage.net/details.php?id=46434
ADY Earnings Call Fri Morn $3.10 share Net Book $9.33 Do the DD ADY 1 of few LEGIT Chinas listed here's why & easy double++ in 2012
One of the very rare Chinas to SELL assets to pay off debt typically we have seen Chinas buying real estate or some factory at huge bloated prices....
Only China to actually lower share count by buying back preferred shares paying back to Sequioa Capital 65 Mill $$$ Instead of letting them convert at $3 a share !!!!!!!!!!!! That never happens right EVERY China would have let them convert into shares.
Milk is one of the toughest regulated industries in China especially after the Melamine debacle in 2008 which BTW ADY was one of the only companies NOT involved in any way as testing of their milk came out squeaky clean....
Highly profitable 2011 & now the drag of their dairy farms is behind them & should put up a banner year ... Trading at 2 to 3X's EPS for 2012 as a legitimate China Company should bode very $$$$ well for those buying while all Chinas considered a fraud....
BTW Famous Short Alfred Little with his investigators on the ground in China is LON
public since 2003 & NEVER EVER been accused of Fraud as there is no doubt about ADY's legitimacy ....
Look at chart history on Melamine debacle ADY soared to $40's a share & historically a $10+ a share stock & imo deserves to be there now & will be in 2012...
very very good read on ADY
http://seekingalpha.com/article/288467-feihe-international-rapidly-improving-balance-sheet-growing-market-share-and-strong-earnings
ADY Link to upgrade article & keep in mind full effects of farm sales not included in debt ratios nor is preferred shares that were repaid.
http://www.thestreet.com/story/11471302/1/feihe-international-inc-stock-upgraded-ady.html
ADY weakness ? geez at 61 mill $$$ Mkt Cap vs SYUT's 335 Mill $$$ Mkt Cap & ADY with a far better balance sheet ADY would need to go to $16 a share to equal SYUT's valuation. Imo without the dairy farm drag ADY is now trading at 2 to 3X's Net Income & far below the approx $10 a share in Net Tangible Assets after Debt valuation.... BTW SYUT's after debt valuation is $1.55. I'll take my chances with ADY being found soon.
ADY good news for ADY bad news for Abbott Abbott Laboratories Chinese Infant Formula Violates China National Standards, According to Tests
PR NewswirePress Release: CER Research –
HONG KONG, March 22, 2012
/PRNewswire-Asia/ -- An infant formula product produced by Abbott Laboratories (ABT.NYSE), failed to reach China national safety standards and tested worst among a selection of six infant formula powders sold on the Chinese market, according to a research report released by Hong Kong-based research house CER Research on Thursday.
The release of the research report on Abbott's Similac Stage 1 milk powder product coincided with Chinese media reports Wednesday of a father in the China city of Hangzhou who says he had found half of a condom inside an Abbott milk powder package which he had purchased for his daughter.
CER Research said it sent samples of six infant formula products bought in Shanghai and Hong Kong to a professional food testing laboratory, Muva Kempten in Allgau, Germany, for analysis, and had planned to use the Abbott product as a benchmark for quality, on the assumption that it would top the results.
"To our surprise, the Abbott product tested the worst of the six samples provided, and well below accepted international and even China standards," said CER Research CEO, Graham Earnshaw.
China requires infant formula to have a minimum whey to casein protein ratio of at least 60%. Abbott Similac Stage 1 product, bought in Hong Kong on December 16, 2011, failed to meet the standard by a wide margin. The tests also showed the Abbott product to have a very high heat treatment intensity. These are both significant negative factors with regard to infant formula.
High intake of casein protein has been shown to cause intestinal bleeding, malnutrition, diarrhea and kidney stress in infants.
The Research Director of INRA, the French National Institute for Agricultural Research, specializing in milk and egg research, Dr Didier Dupont, examined the Abbott sample test results and said that the whey/casein ratio was below accepted standards and the level of denaturation was "extremely high".
"Personally, I would not give this formula to my children," Dr Dupont said.
Abbott's total mainland China revenues for 2011 are estimated to have been between US$0.95 billion - US$1.10 billion, based on CER Research's investigations.
The full report, headlined "Abbott Laboratories Similac Stage 1; A First Step Towards Malnutrition", is available at www.cerresearch.com.
CER Research said it had submitted the test results and report findings to the relevant food quality assessment government organizations in Shanghai and Guangdong province – the Shanghai Municipal Bureau of Quality and Technical Supervision and the Administration of Quality and Technology Supervision of Guangdong Province. Both confirmed receipt and said they are looking into the case.
The poor performance of the Abbott infant formula product was confirmed in additional testing performed by DTS Food Laboratories in Kensington, Australia.
CER Research called Abbott Laboratories Hong Kong office and asked to speak to the quality control manager about a product quality issue and the receptionist declined to transfer the call without a specific name being offered.
"But to be clear, this is with regard to an important issue of product quality," the CER Research staff member said.
"I have to follow company policy," replied the Abbott receptionist.
The view of CER Research would be that a company selling milk powder and other similar consumer products should be willing to take calls with regard to product quality for consumers. The fact Abbott is not willing to do so is another indication that the company has a problem in terms of quality control in the China market.
CER Research provides due diligence and financial analysis services to companies looking to invest or do business in China.
Contact:
Graham Earnshaw
graham.earnshaw@cerresearch.com
+852 3174 6136
+86 139 016 68748
ADY 1 of few LEGIT Chinas listed here's why & easy double++ in 2012
One of the very rare Chinas to SELL assets to pay off debt typically we have seen Chinas buying real estate or some factory at huge bloated prices....
Only China to actually lower share count by buying back preferred shares paying back to Sequioa Capital 65 Mill $$$ Instead of letting them convert at $3 a share !!!!!!!!!!!! That never happens right EVERY China would have let them convert into shares.
Milk is one of the toughest regulated industries in China especially after the Melamine debacle in 2008 which BTW ADY was one of the only companies NOT involved in any way as testing of their milk came out squeaky clean....
Highly profitable 2011 & now the drag of their dairy farms is behind them & should put up a banner year ... Trading at 2 to 3X's EPS for 2012 as a legitimate China Comapny should bode very $$$$ well for those buying while all Chinas considered a fraud....
BTW Famous Short Alfred Little with his investigators on the ground in China is LON
public since 2003 & NEVER EVER been accused of Fraud as there is no doubt about ADY's legitimacy ....
Look at chart history on Melamine debacle ADY soared to $40's a share & historically a $10+ a share stock & imo deserves to be there now & will be in 2012...Heck was $4 just 6 days ago ....
very very good read on ADY
http://seekingalpha.com/article/288467-feihe-international-rapidly-improving-balance-sheet-growing-market-share-and-strong-earnings
ADY agreed as I haven't been invested in China stocks for 14 months now, traded a few but ADY the more I dig the more I agree is one of the few legit co.s trading on U.S. Mkts... Very rare to see a co. SELLING assets to pay debt as it's always Buying some over priced something to strip cash away from co. Also when did you ever see a China co BUY back preferred shares rather then let them convert ??? reducing share count by millions of shares approx 17+ million VS current 21 Million shares for ADY. Seems with a very profitable 2011 in the books & getting rid of drag on profits ( milk Farms) ADY will be far more profitable coupled with new high margin Astrobaby milk gaining significant mkt traction. This co has a share price history normally 5 to 10X's current pricing.
Who can forget that run from $10 to $44 in middle of 2009 ....
ADY very different China co Selling assets to pay debt rather then buying some crazy bloated co or real estate deal to rob money. Also of note ADY buying back preferred shares from Sequoia instead of letting them convert into common shares ??? thus reducing shares outstanding by several million shares. ADY been around a very long time & never accused of being a fraud & with latest moves imo setting up to have some really profitable quarters coming up. BTW been out of China stocks since Jan 2011 & ADY the first to pique my interest.
ADY nice low vol pullback after high vol up days reloading $3.50's
ADY starting to catch fire nice turnaround for possibly one of the few China legit co.s listed
TBET 11 mill $$$ Mkt Cap besides 26 Mill in Cash has $3.30 a share in Net Tangible Assets after Debt...Doubled in Dec to Jan s/b a high % winner again big vol bar today...
TBET getting Vol $1.75 Cash .83 cents IPOd at $5.50 a share last year
TBET vol picking up $1.75 in Cash @ .83 IPO last year at $5.50 a share looks interesting for % move
QCOR agreed QCOR will be a great $$$ maker this week imo easily s/b $38 to $40 after earnings blowout....
PERF s/b on watchlist was $19 weeks ago now $10 after announcing a buyout of PARL.
PERF CEO & family own 82% of total outstanding leaving just over 900K Float & CEO & family putting in 30 million dollars from their own pockets to help finance the buyout so they obviously believe in the deal despite the share price. Perfumania stores across the U.S doing double digit growth. PERF moves quickly when in play got way to cheap imo.
http://finance.yahoo.com/news/Perfumania-Holdings-Inc-pz-1404203964.html?x=0
ZGNX picture perfect setup after digesting a double last month looking now for next leg up. Spent last few weeks digesting monster move
ZGNX strong volume again $2.34 been digesting a monster move up very well $1.40 to $2.40 in days... 4 Big Analysts with a combined $5.33 target on ZGNX. Will be announcing new partner on migraine drug next few weeks as per CEO on last CC.
ZGNX seems to be helping not hurting as above avg vol & price action yesterday. Reading through the comments overwhelmingly positive to have a safer Hydrocodone product in extended release & APAP free which would eliminate liver toxicity... Even more so some realize the dollar potential of Zohydro Oppenhiemer pegs it around 500 million a year for Zohydro coupled with their migraine drug still growing sales would easily be a $10 to $15 stock. Then throw out there the next Oxycontin & some see $$$$ signs....imo only FDA needs & wants an Acetaminophen free Hydrocodone as they almost eliminated the entire Hydrodone class
http://www.news-record.com/content/2011/01/13/article/fda_limits_key_ingredient_in_vicodin_other_painkillers
ZGNX nice tax loss selling over $1.90's from $1.40 & imo s/b $3's right now imo... do DD huge mkt for ZGNX first to mkt APAP free & first to Mkt Extended release Hydrocodone..
ZGNX continued above avg Vol $1.85 from $1.40 nice imo s/b $3's now as dirt cheap with high growth FDA approved migraine drug & a soon to approved first to Mkt extended release & first to mkt APAP free Hydrocodone drug ...estimates for max sales of new drug 500 mill $$$ a year current mkt cap 120 mill $$$$
ZGNX nice up vol today $1.79 & Insiders loaded 7 million shares at $2 ...ZGNX has no business being under $2 & imo will be a triple digit % winner in 2012
ZGNX Tax Loss selling over ?? DD Almost at Cash Insiders bought 7.1 mill shares @ $2 now $1.57 DD on ZGNX 99 Mill $$$ Mkt Cap 71 Mill in Cash & approved Migraine drug doing 40 mill in sales 2011 & projected to do 80 mill in 2012 BUT their big dollar drug has phase 3 trials completed & positive on their ( First to Market ) Extended release Hydrocodone drug & also ( First to Market ) APAP free or Acetaminophen free ( causes Liver Toxicity) & FDA cracking down on it. ZGNX according to last CC has already been approached by Pharmas looking to partner up on drug & will make a decision in early 2012 whether to partner or go alone. Why go alone ??? Huge market for Hydrocodone ( Over 6 Billion Dollars a Year ) & Oppenhiemer has opined that ZGNX drug will do around 500 Million a year in sales. Insiders know the potential & have bought over 56% of the total outstanding shares 36.4 Million shares including the 7.1 Million shares purchased in September. Coupled with the 18 Million shares just purchased in the last 3 months by Institutions which now totals over 25 million shares & growing . BTW 18 million shares bought 11 thousand shares sold ???? FLOAT is around 4 Million shares 4 MILLION ...This is a sure shot double/triple/??? easily could be another INHX $2 to $10 quickly on FDA or Partner news or a straight buyout..INSANE Valuation here though
Oppenheimer anticipates positive top-line Phase III results from ZGNX's Zohydro by the end of August, potentially driving the shares to the ~$5-6 range. As a reminder, Zohydro is ZGNX's novel, oral, single-entity controlled-release formulation of hydrocodone, intended to treat moderate to severe chronic pain. Our positive bias on Phase III results is based on strong phase II data, as well as the well-understood safety/efficacy profile of the hydrocodone class. If approved, they estimate Zohydro's relative advantages in safety and dosing convenience could help garner a meaningful portion of the branded hydrocodone market, resulting in peak sales of ~$500 mln. On positive data, they anticipate ZGNX to file an NDA in 2012, followed by an acceleration in partnership discussions later in 2012.
No dilution till 2013 & that's IF they go it alone if they partner they will have 100's of millions of dollars....
From S.E.C. filing of latest 10Q
As of September 30, 2011, we had cash and cash equivalents of $70.8 million. We believe that our cash and cash equivalents as of September 30, 2011, together with future revenue and borrowings available under our $10.0 million revolving credit facility, will be sufficient to fund our operations into the second quarter of 2013.
ZGNX amazing every Dec the crazy prices stocks hit when some fund dumps just to get it off their books and why not it's not their money... Jan effect s/b in play for ZGNX as s/b $3 to $4 a share right now when considering they have a growing FDA approved drug & another high % approval high dollar drug about to be approved.... will be a triple digit gainer in 2012 for sure....
ZGNX DD Almost at Cash Insiders bought 7.1 mill shares @ $2 now $1.44 DD on ZGNX 95 Mill $$$ Mkt Cap 71 Mill in Cash & approved Migraine drug doing 40 mill in sales 2011 & projected to do 80 mill in 2012 BUT their big dollar drug has phase 3 trials completed & positive on their ( First to Market ) Extended release Hydrocodone drug & also ( First to Market ) APAP free or Acetaminophen free ( causes Liver Toxicity) & FDA cracking down on it. ZGNX according to last CC has already been approached by Pharmas looking to partner up on drug & will make a decision in early 2012 whether to partner or go alone. Why go alone ??? Huge market for Hydrocodone ( Over 6 Billion Dollars a Year ) & Oppenhiemer has opined that ZGNX drug will do around 500 Million a year in sales. Insiders know the potential & have bought over 56% of the total outstanding shares 36.4 Million shares including the 7.1 Million shares purchased in September. Coupled with the 18 Million shares just purchased in the last 3 months by Institutions which now totals over 25 million shares & growing . BTW 18 million shares bought 11 thousand shares sold ???? FLOAT is around 4 Million shares 4 MILLION ...This is a sure shot double/triple/??? easily could be another INHX $2 to $10 quickly on FDA or Partner news or a straight buyout..INSANE Valuation here though
Oppenheimer anticipates positive top-line Phase III results from ZGNX's Zohydro by the end of August, potentially driving the shares to the ~$5-6 range. As a reminder, Zohydro is ZGNX's novel, oral, single-entity controlled-release formulation of hydrocodone, intended to treat moderate to severe chronic pain. Our positive bias on Phase III results is based on strong phase II data, as well as the well-understood safety/efficacy profile of the hydrocodone class. If approved, they estimate Zohydro's relative advantages in safety and dosing convenience could help garner a meaningful portion of the branded hydrocodone market, resulting in peak sales of ~$500 mln. On positive data, they anticipate ZGNX to file an NDA in 2012, followed by an acceleration in partnership discussions later in 2012.
No dilution till 2013 & that's IF they go it alone if they partner they will have 100's of millions of dollars....
From S.E.C. filing of latest 10Q
As of September 30, 2011, we had cash and cash equivalents of $70.8 million. We believe that our cash and cash equivalents as of September 30, 2011, together with future revenue and borrowings available under our $10.0 million revolving credit facility, will be sufficient to fund our operations into the second quarter of 2013.
ZGNX Newswire also tax loss selling Insiders bought 7.1 mill shares @ $2.00 now $1.42
Zogenix Completes Zohydro(TM) Pre-NDA Meetings With FDA
Zohydro NDA Submission on Track
Press Release: Zogenix – 4 minutes 9 seconds ago....
......SAN DIEGO, Dec. 20, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has concluded its pre-New Drug Application (NDA) meetings with the U.S. Food & Drug Administration (FDA) related to its lead investigational product candidate, Zohydro(TM) (hydrocodone bitartrate extended-release capsules). The purpose of the meetings was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Zohydro, and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. After a detailed review of the submission timeline, Zogenix plans to submit the NDA for Zohydro early in the second quarter of 2012.
Stephen Farr, PhD, president and chief operating officer of Zogenix, said, "The completion of our pre-NDA meetings with the FDA brings us one more important step closer to potentially gaining approval for Zohydro. We appreciate the informative interactions, timeliness, and clarity provided by the FDA, as well as the full support of Alkermes, our CMC partner, in the pre-NDA meeting process."
Zohydro is being evaluated for the management of moderate to severe chronic pain in patients requiring continuous around-the-clock opioid therapy for an extended period of time. If approved, Zohydro could be the first extended-release hydrocodone therapy available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.
Hydrocodone pain products represent the largest prescription drug category in the United States, with over 128 million prescriptions filled in 2010. The Company believes Zohydro's ability to provide consistent 12-hour pain relief, without exposure to acetaminophen, will position the product well in this large market.
About Zohydro
Zohydro is a novel, oral, single entity (without acetaminophen) extended-release capsule formulation of hydrocodone bitartrate. When used in high dosages over time, acetaminophen can cause liver toxicity. If approved, Zohydro could be the first single-entity hydrocodone therapy available. Zohydro uses Alkermes' patented Spheriodal Oral Drug Absorption System (SODAS(R)) drug delivery technology which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate release combination products. Capsule strengths utilized in the Phase 3 studies included 10, 20, 30, 40 and 50 mg capsules.
About Chronic Pain
The American Pain Society estimated in 1999 that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain. Chronic pain can be treated with both immediate-release and extended-release opioids. Marketed hydrocodone products are the most commonly prescribed pharmaceuticals in the U.S., generating $3.2 billion in sales during the 12 months ended December 2010 (Wolters Kluwer Pharma Solutions, Source Pharmaceutical Audit Suite Retail, January 2010 -- December 2010). All of these hydrocodone products contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen may cause liver toxicity when used in high dosages over time.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX - News), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL(R) DosePro(R) (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro(TM) (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase 3 clinical trials for the management of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix's second investigational DosePro product candidate, Relday(TM), is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia
ZGNX also tax loss.. 100 Mill $$$ Mkt Cap 71 Mill in Cash & approved Migraine drug doing 40 mill in sales 2011 & projected to do 80 mill in 2012 BUT their big dollar drug has phase 3 trials completed & positive on their ( First to Market ) Extended release Hydrocodone drug & also ( First to Market ) APAP free or Acetaminophen free ( causes Liver Toxicity) & FDA cracking down on it. ZGNX according to last CC has already been approached by Pharmas looking to partner up on drug & will make a decision in early 2012 whether to partner or go alone. Why go alone ??? Huge market for Hydrocodone ( Over 6 Billion Dollars a Year ) & Oppenhiemer has opined that ZGNX drug will do around 500 Million a year in sales. Insiders know the potential & have bought over 56% of the total outstanding shares 36.4 Million shares including the 7.1 Million shares purchased in September. Coupled with the 18 Million shares just purchased in the last 3 months by Institutions which now totals over 25 million shares & growing . BTW 18 million shares bought 11 thousand shares sold ???? FLOAT is around 4 Million shares 4 MILLION ...This is a sure shot double/triple/??? easily could be another INHX $2 to $10 quickly on FDA or Partner news or a straight buyout..INSANE Valuation here though
Oppenheimer anticipates positive top-line Phase III results from ZGNX's Zohydro by the end of August, potentially driving the shares to the ~$5-6 range. As a reminder, Zohydro is ZGNX's novel, oral, single-entity controlled-release formulation of hydrocodone, intended to treat moderate to severe chronic pain. Our positive bias on Phase III results is based on strong phase II data, as well as the well-understood safety/efficacy profile of the hydrocodone class. If approved, they estimate Zohydro's relative advantages in safety and dosing convenience could help garner a meaningful portion of the branded hydrocodone market, resulting in peak sales of ~$500 mln. On positive data, they anticipate ZGNX to file an NDA in 2012, followed by an acceleration in partnership discussions later in 2012.
No dilution till 2013 & that's IF they go it alone if they partner they will have 100's of millions of dollars....
From S.E.C. filing of latest 10Q
As of September 30, 2011, we had cash and cash equivalents of $70.8 million. We believe that our cash and cash equivalents as of September 30, 2011, together with future revenue and borrowings available under our $10.0 million revolving credit facility, will be sufficient to fund our operations into the second quarter of 2013.
ZGNX 110 Mill $$$ Mkt Cap 71 Mill in Cash & approved Migraine drug 40 mill in sales 2011 & projected 80 mill in 2012 BUT has phase 3 trials completed & positive on their ( First to Market ) Extended release Hydrocodone drug & also ( First to Market ) APAP free or Acetaminophen free ( causes Liver Toxicity) & FDA cracking down on it. ZGNX according to last CC has already been approached by Pharmas looking to partner up on drug & will make a decision in early 2012 whether to partner or go alone. Why go alone ??? Huge market for Hydrocodone over 6 Billion Dollars a year & Oppenhiemer has opined that ZGNX drug will do around 500 Million a year in sales. Insiders know the potential & have bought over 56% of the total outstanding shares 36.4 Million shares including the 7.1 Million shares purchased in September. Coupled with the 18 Million shares just purchased in the last 3 months by Institutions which now totals over 25 million shares & growing . BTW 18 million shares bought 11 thousand shares sold ???? FLOAT is around 4 Million shares 4 MILLION ...This is a sure shot double/triple/??? easily could be another INHX $2 to $10 quickly on FDA or Partner news or a straight buyout....INSANE Valuation here though.....
ZGNX Phase 3 Data already out & positive & since long term safety studies also completed & positive...So it appears FDA approval is very high & will be 2nd approved drug & this drug hitting in a high dollar arena. Seems ZGNX will be much much higher in the weeks & months ahead imo...
http://finance.yahoo.com/news/Zogenix-Reports-Positive-pz-2308373064.html?x=0&.v=1
ZGNX completed offering at $2.00 share & Oppenhiemer stated their drug Mkt is closer to 500 Million Dollars.
Oppenhiemer Analyst note before Positive phase 3 results... Zogenix: Positive top-line Zohydro phase III results by end of August - Oppenheimer (4.07 )
Oppenheimer anticipates positive top-line Phase III results from ZGNX's Zohydro by the end of August, potentially driving the shares to the ~$5-6 range. As a reminder, Zohydro is ZGNX's novel, oral, single-entity controlled-release formulation of hydrocodone, intended to treat moderate to severe chronic pain. Our positive bias on Phase III results is based on strong phase II data, as well as the well-understood safety/efficacy profile of the hydrocodone class. If approved, they estimate Zohydro's relative advantages in safety and dosing convenience could help garner a meaningful portion of the branded hydrocodone market, resulting in peak sales of ~$500 mln. On positive data, they anticipate ZGNX to file an NDA in 2012, followed by an acceleration in partnership discussions later in 2012.
They just completed a large offering raising 65 million dollars in middle of Sept & stated s/b enough to get through FDA approval & ready their drug launch. The offering is the only reason it's this low & again Insiders bought 7.1 Million shares of this offering in addition to the millions of shares already owned. GLTY & make $$$$$$$$
Sheff Can I ask your thoughts on ZGNX thanks
ZGNX not sure if anyone here following Insiders own a ton of stock & bought another 7 million shares on last offering at $2.00. Has a positive phase 3 trial completed & will apply for FDA approval in 2012 with a 2013 launch. Their target Mkt is the largest in the U.S 131 Million scripts written for Hydrocodone.Been churning in base here at $2 for last 6 weeks & looking slightly better lately From CEO
Roger Hawley, Chief Executive Officer of Zogenix, said, "These positive results represent an important step forward in the commercialization of our extended-release hydrocodone. Adding Zohydro as our second commercial product would be transformational for Zogenix's business, given the number of chronic pain patients and the growing physician demand for an acetaminophen-free hydrocodone product. If approved, as planned, we intend to expand our sales force in order to be in a position to educate prescribers about this important new option for chronic pain management and assume a greater promotional responsibility for SUMAVEL DosePro."
"Stephen J. Farr, Ph.D., President and Chief Operating Officer of Zogenix, "We are very encouraged by the study results, which we believe are meaningful for patients suffering from moderate to severe chronic pain. Zohydro will offer hydrocodone for the first time in a convenient 12-hour dose while eliminating acetaminophen. Zohydro may simplify physicians' ability to prescribe the appropriate hydrocodone dose for chronic pain while managing the inadvertent overuse of acetaminophen, which is a common ingredient in combination pain products and over-the-counter medications."
ZGNX not sure if anyone here following Insiders own a ton of stock & bought another 7 million shares on last offering at $2.00. Has a positive phase 3 trial completed & will apply for FDA approval in 2012 with a 2013 launch. Their target Mkt is the largest in the U.S 131 Million scripts written for Hydrocodone.Been churning in base here at $2 for last 6 weeks & looking slightly better lately From CEO
Roger Hawley, Chief Executive Officer of Zogenix, said, "These positive results represent an important step forward in the commercialization of our extended-release hydrocodone. Adding Zohydro as our second commercial product would be transformational for Zogenix's business, given the number of chronic pain patients and the growing physician demand for an acetaminophen-free hydrocodone product. If approved, as planned, we intend to expand our sales force in order to be in a position to educate prescribers about this important new option for chronic pain management and assume a greater promotional responsibility for SUMAVEL DosePro."
"Stephen J. Farr, Ph.D., President and Chief Operating Officer of Zogenix, "We are very encouraged by the study results, which we believe are meaningful for patients suffering from moderate to severe chronic pain. Zohydro will offer hydrocodone for the first time in a convenient 12-hour dose while eliminating acetaminophen. Zohydro may simplify physicians' ability to prescribe the appropriate hydrocodone dose for chronic pain while managing the inadvertent overuse of acetaminophen, which is a common ingredient in combination pain products and over-the-counter medications."
LPH agreed $1.60's to .90's & 10K will happen as if there wasn't going to be one I'm sure LPH would have stayed quiet .... Certainly no CC & Q & A...
LPH guess they will file 10K ..Newswire...
Longwei Petroleum Announces Conference Call to Discuss Fiscal 2011 Financial Results
Last update: 9/9/2011 2:29:00 PM
TAIYUAN CITY, China, Sept. 9, 2011 /PRNewswire via COMTEX/ -- Longwei Petroleum Investment Holding Ltd. (LPH) ("Longwei" or the "Company"), an energy company engaged in the storage and distribution of finished petroleum products in the People's Republic of China ("PRC"), today announced that it will hold a conference call to discuss its financial results for the fiscal year ended June 30, 2011.
The conference call is scheduled for Wednesday, September 14, 2011 at 10:00 a.m. EDT (7:00 a.m. PDT). Mr. Michael Toups, Chief Financial Officer, will host the call and be available during the question-and-answer session.
To participate in the call, please dial (888) 634-9984, or (719) 325-2286 for international calls, approximately 10 minutes prior to the scheduled start time. Interested parties can also listen via a live Internet webcast, which can be found via the Company's website at , or alternately at .
A replay of the call will be available for two weeks from 1:00 p.m. EDT on September 14, 2011, until 11:59 p.m. EDT on September 28, 2011. The number for the replay is (877) 870-5176, or (858) 384-5517 for international calls; the passcode for the replay is 9461341. In addition, a recording of the call will be available via the Company's website at for one year.
About Longwei Petroleum Investment Holding Limited