Able Laboratories (MM) (ABRX) News

4 admit fraud at now-defunct Able Laboratories
By JEFFREY GOLD
AP Business Writer

March 8, 2007, 4:40 PM EST

NEWARK, N.J. -- Four managers at the now-defunct Able Laboratories Inc. pleaded guilty Thursday to roles in a scheme to falsify data at the generic drug maker, a seven-year plot that ultimately led to the company's collapse.

The highest-ranking of the four, Shashikant Shah, vice president for quality control and regulatory affairs, also pleaded guilty to conspiring to commit securities fraud, admitting that he netted more than $900,000 by selling company stock while aware of the illegal test practices.

All four implicated the company's chief executive officer, Dhananjay G. Wadekar. He was not named in court and faces no charges to date.

"The investigation is active and ongoing," Assistant U.S. Attorney Robert A. Kirsch said.

The Cranbury-based company had made 46 generic versions of name-brand drugs for pain, inflammation, obesity and cardiovascular conditions.

"The damage from the fraud at Able Labs was devastatingly complete," U.S. Attorney Christopher J. Christie said. "Consumers were put at risk, a company that employed 500 people was destroyed, and shareholders were left with nothing in the end."

The guilty pleas represent the first criminal charges regarding Able, which began its slide in 2005 when federal regulators said the company falsified test results.

The Food and Drug Administration has said Able created data so its drugs would appear to meet federal standards when they did not. In 41 incidents dating to 2001, drugs were found to have too much or too little of their active ingredients. However, each time their strength was reported to be within legal limits, the FDA said. On nine other occasions, Able failed to issue alerts about impure drugs, the FDA said.

From 1999 _ when the defendants said the plot began _ to 2002, Able's shares traded from 17 cents a share to 55 cents a share. Its stock then climbed dramatically, along with sales and product lines, reaching a record high of $26.50 in May 2005, prosecutors said.

But later that month, Able announced it was suspending shipments of all drugs, and recalling some of them. The stock dropped 75 percent in a day to $6.36 a share, a $340 million meltdown, Kirsch said. All its products were ultimately recalled, he said.

Able filed for bankruptcy reorganization in July 2005, but changed to liquidation in March 2006.

The CEO, Wadekar, resigned after problems emerged in 2005. A listing could not be found for him, and prosecutors declined to comment on whether he had a lawyer.

In pleading guilty to stock fraud, Shah, 65, of Dayton, admitted that his insider trades gave him profits of over $900,000, and that other executives who got stock options were also aware of data falsification.

In addition to the criminal charges, Shah consented to return ill-gotten gains, with interest and penalties, as part of an insider trading civil action filed by the Securities and Exchange Commission on Thursday. He agreed to be barred for five years from serving as an officer or director of a public company.

Also pleading guilty Thursday to one count of conspiracy to distribute misbranded and adulterated drugs were Jyotin Parikh, 56, of Clifton, who was Able's laboratory manager in its quality control department from mid-2000 through the beginning of 2005; Ashish Macwan, 47, of Tinton Falls, Able's group leader, supervisor, and assistant manager in its quality control department, and Jose Concepcion, 57, of Hazlet, Able's group leader and supervisor in the quality control department.

All four face up to five years in prison and a $250,000 fine when sentenced July 24 by U.S. District Judge Susan D. Wigenton.

On the Net:

U.S. Attorney's Office: http://www.usdoj.gov/usao/nj/press/index.html

Were ABRX insiders paid to dump the business? Just a thought that came to mind. No proof! Just thought!

http://biz.yahoo.com/ap/060424/ftc_drugs.html?.v=2

Generic Drug Payoff Draws Gov't. Interest
Monday April 24, 9:00 pm ET
By Andrew Bridges, Associated Press Writer
Payoff of Generic Drug Companies by Brand-Name Makers Draws Government Regulatory Interest


WASHINGTON (AP) -- Brand-name pharmaceutical companies have resumed paying generic drug manufacturers to stay off the market under the terms of some legal settlements, attracting renewed scrutiny from federal regulators, trade officials said Monday.

For the first time since 1999, brand-name and generic drug makers are entering patent challenge agreements under which the latter companies receive compensation in exchange for agreeing to restrictions on their ability to market generic versions of branded drugs.

Consumers usually save money if they can buy generic brands of drugs, which spark price competition. Keeping generic competitors off the market allows brand-name manufacturers to charge premium prices.

Three such settlements were reached in the 12 months ending Sept. 30, 2005, according to a Federal Trade Commission report issued Monday. Roughly six similar deals have been struck in the months since then, FTC Commissioner Jon Leibowitz said.

Pharmaceutical companies ceased striking such agreements in the late 1990s following several legal challenges mounted by the FTC, Leibowitz said.

Pharmaceutical companies have been emboldened by two recent court decisions that sanctioned those types of settlements, Leibowitz said in remarks prepared for a speech Monday in Philadelphia. The remarks were posted on the FTCs Web site.

"We are seeing far more settlements today that potentially raise competition concerns than before these decisions," Leibowitz said.

The FTC commissioner cited the recent example of Plavix, a blood-thinning drug made by Sanofi-Aventis and distributed in the United States by Bristol-Myers Squibb that has $3.8 billion in annual sales. The two companies recently settled with Apotex Corp., which sought to market a generic version of the drug.

Under the terms of that settlement, filed with the FTC, the two companies will pay Apotex an undisclosed sum. Apotex in turn agreed to defer launching its generic version of Plavix until 2011.

That deferral could cost consumers hundreds of millions of dollars, Leibowitz said.

"Our staff will take a good hard look at this -- as we should -- and the commission will decide what action to take, if any," he said.

The FTC has asked the Supreme Court to reverse an 11th Circuit Court of Appeals decision in a similar case involving the drug company Schering-Plough. If the Supreme Court doesn't, it could give brand-name and generic companies "carte blanche to avoid competition and share resulting profits," Leibowitz said.

A spokesman for the Pharmaceutical Research and Manufacturers of America declined to comment. A spokeswoman for the Generic Pharmaceutical Association said the group is reviewing the report.

The FTC said last month it planned to subpoena nearly 200 pharmaceutical companies as part of a probe of possible anticompetitive practices in the prescription drug industry.

The subpoenas, which require Office of Management and Budget approval, would form part of an investigation into whether pharmaceutical companies are stifling competition by releasing authorized generic copies of their own brand-name drugs to coincide with the debut of generic challengers made by competitors.

Federal Trade Commission: http://www.ftc.gov

I highly doubt it. ABRXQ will be cancelled IMO. Bankruptcy stocks, however, tend to make some fantastic moves for big profits if played right.

Been on a roll the last 2 days. Any news?

Nah.

Rawnoc, is CMBV up your ally today?

OT: RAW ya check CMED?

plus ABRXQ still trades and may make for some trading opportunities to discuss here until the stock is officially cancelled. ;)

don't have the power to delete a board. Maybe if a new company takes its symbol some day it will be naturally deleted.

Time to delete IHUB ABRX, Rawnoc!

Its all over!

Salute!

RIP Able Labatories

Guess this was it. Probably will loose everything I invested.

Newby on the board

Hi to all

Recently I took ABRXQ in my portfolio and already lost thousends. Is there anyone around who can spread some light on what is happening here. If the stock is so low now, would it not make Able Labatories a take over candidate?

I bought another 10K to downtrade my average, but I am quite uncertain now.

Any reactions welcome.

So is $1 a good entry point or do wa wait until after BK?

Able Labs cancels shareholders meeting,
Fri Jul 1, 2005 05:41 PM ET

The company announced the cancellation after the market closed, but in after-hours activity shares plunged 22 percent to $2.75 on the Inet electronic brokerage system from a close of $3.52 on Nasdaq.
---------------------------------------------
After Hours (RT-ECN):$2.70 0.82 (23.30%)
---------------------------------------------

Posted 6/19/2005 9:17 PM Updated 6/20/2005 4:25 AM
http://www.usatoday.com/money/industries/health/drugs/2005-06-19-able-usat_x.htm

Massive drug recall spurs questions
By Julie Schmit, USA TODAY
A small New Jersey company is at the center of one of the biggest drug recalls ever, and a month after it began, little is clear about why millions of doses were suddenly pulled off the market.
Able Laboratories, a growing maker of generic prescription drugs, recalled all of its products on May 23, saying deficiencies in its testing procedures might have resulted in "sub or super potent" drugs.

The Food and Drug Administration says millions of doses were likely in the market. "We're getting reports of a large number of products being recalled, literally truckloads," says Margaret Glavin, associate commissioner at the FDA.

Check your drugs

Consumers who have drugs made by Able Laboratories should return them to their pharmacies, the FDA says.
Bottles or packages may not say the name Able. But numbers or letters imprinted on tablets or capsules will identify them. A recall list is at:
www.fda.gov
www.ablelabs.com
Able can be reached at: 800-982-2253.


Able produces about 30 generic drugs, some well known, including generic versions of the painkiller Vicodin, Tylenol with codeine, blood-pressure drug Atenolol and nitroglycerin tablets for chest pain.

Promethazine, an antihistamine, is its top seller, with more than 50% of the generic U.S. market.

The recall — highly unusual because all products were involved — has devastated Able and shareholders. Able's stock has dropped 86% since mid-May.

The recall is also likely to raise questions for the FDA. Able passed 11 FDA plant inspections in the past three years, the FDA says. Never did the FDA raise what it considered to be a serious concern about the company's manufacturing processes.

When all is known, "The FDA might end up with egg on its face," says Sharon di Stefano, stock analyst with Sky Capital. "The recall was unprecedented and shocking."

Able's downfall was swift

May 5: Able announces first-quarter revenue up 43% to $30.7 million. Damage was "fairly contained," CEO says in next-day conference call when questioned about a February product recall. "I thought to myself, 'Oh, no big deal,' " says Tom Bishop, editor of investment newsletter BI Research.

May 10: Able files a report with Securities and Exchange Commission. It says company is probing operating practices because of three recent product recalls.

May 19: Able says it suspended shipments, found "departures from standard operating procedures" in lab testing and that the CEO was resigning.

May 23: Able announces total recall.

May 25: Able tells customers what to do with their drugs.

June 9: Able announces more job cuts, in addition to the 200 announced on May 27.


The recall's exact size won't be known for weeks or months. Able produced 1.3 billion tablets, capsules and suppositories last year.

Drugs made earlier might be in the market, too, if they haven't expired.

The FDA and the company advise consumers to keep taking the drugs until they get new medications from their doctors. A sudden stop could do more harm than taking a possibly compromised drug, they say.

"The drugs might be fine, but you just don't know," says Sheila Weiss Smith, associate professor in the University of Maryland's school of pharmacy.

Manufacturing ends

Since the recall, Able, with sales of $103 million last year, has halted manufacturing and laid off more than half its 400 employees. Its CEO and co-founder, Jay Wadekar, has resigned, and the company has given no assurance as to when, or if, it'll resume production.

"I've never heard of a recall resulting in the shutdown of an entire company," Smith says. "It's hard to tell if this was a new problem or something that had been going on for a long time."

The company has refused to comment. Wadekar could not be reached. Calls to four Able board members were not returned. At least eight shareholder lawsuits have been filed since the recall's announcement

"The board is diligently working to solve the problem," says company adviser Mallory Factor, who refused to comment further.

The first hints of trouble emerged in mid-May, when Able announced an internal review after recalling three products in the first quarter. Days later, Able said some laboratory testing practices showed "departures from standard operating procedures."

The full recall came four days later.

It was also three months after the FDA had inspected the South Plainfield, N.J., plant, where most of Able's production was done. The February inspection, designed to check the practices that Able later said were lacking, turned up nothing that would warrant an FDA warning letter, the FDA says. Warning letters are made public and demand corrections under threat of more serious sanctions.

Five of the FDA's 11 Able inspections since early 2002 looked at the company's manufacturing practices, the FDA says. The others focused on new-product approvals, so were narrower in scope.

In 2004, Able was cited for failing to tell the FDA about 27 consumers who had adverse reactions after taking Able-made drugs. Seven other drugmakers received warning letters for similar issues since 2002, FDA records show.

While Able repeatedly passed FDA muster in recent years, it hasn't always.

In 1991, the FDA charged Able with failing to comply with good manufacturing practices, and the company operated under a consent decree for 10 years.

Able has also had at least 12 product recalls since 1991, the FDA Web site says. The far bigger generic-drug maker Mylan Laboratories, with $1.3 billion in fiscal 2005 sales, has never had a product recall due to its own error, it says.

Able's recalls show that the company struggled with a broad range of problems:

• In 1993, it recalled non-prescription aspirin and a vegetable laxative that were feared subpotent, and non-prescription cold tablets that had longer expiration dates than allowed.

• In 2001, it recalled 126,000 nitroglycerin tablets, taken for chest pain, because they were mislabeled in terms of strength.

• This year, it recalled 3 million Atenolol tablets, distributed in Florida and Ohio, because of subpotency concerns; 75,000 mislabeled bottles of antibiotic Metronidazole capsules; and 2 million suppositories made of Promethazine Hydrochloride, used to treat allergies and control nausea. The suppositories failed stability tests, which include purity and efficacy.

FDA steps in

The FDA says it's investigating what went wrong at Able.

The company's two biggest distributors, McKesson and Cardinal Health, say they've returned all of their product. They handle about 29% of Able's production.

The recall has also ensnared other companies. Quality Care Products of Michigan bought Able drugs and sold them under the Quality name. Last week, it put out its own recall notice.

It was the first that co-owner and CEO Mike Holmes remembers doing in years — and the first for a manufacturer's entire product line.

The recall won't cost his company much, Holmes says, but "you never want to have your company name in a recall even though we had nothing to do with it."

While Quality expects little sting from the event, Able's future is uncertain.

In addition to suspending manufacturing, Able withdrew seven new drug applications pending at the FDA because it said it can no longer rely on the data upon which they were based.

That is a sharp reversal from the direction Able had been heading. Since 2001, it was FDA-approved to make 25 new drugs. It is close to opening a new plant that could boost production at least 300%.

The trouble that struck the company was unseen on May 5 when Able said first-quarter profit was up 75%.

Several stock analysts, on a conference call with company executives the next day, complimented the strong quarter.

Able Labs' stunning fall still rippling
From Florida to India, other drug firms are feeling the pain
Sunday, June 05, 2005
BY GEORGE E. JORDAN
Star-Ledger Staff
http://www.nj.com/business/ledger/index.ssf?/base/business-0/1117947445116140.xml&coll=1&thi...


Pailla Reddy said he spent last week waiting anxiously by the telephone for a call that never came.

Now, he thinks it never will.

Reddy, chief executive of InvaGen, an upstart pharmaceutical research firm on Long Island, said he had been expecting a $1.5 million check from Able Laboratories, a generic drug maker based in Cranbury. But two weeks ago, Able abruptly halted operations and recalled all of its products from the market. Since then, it has lost its credit line and cut almost half its staff.

The problem for Reddy is that last month Able signed an agreement to produce and sell generic drugs developed by InvaGen, a private venture launched two years ago. The initial payment, for $1.5 million, was due May 27.

"We're going to have financial problems because of these stupid people," Reddy said of Able's executives. "They are not calling me and I want to know what happens. I'm looking for my money."

Now, Reddy said, InvaGen faces the real possibility of going belly up, caught in the backwash of Able's implosion.

InvaGen isn't alone. From Boca Raton, Fla., to Madison, Miss., and Bangalore, India, other drug companies that did business with Able have been hurt by its apparent collapse.

The Able case highlights the complex web of interrelationships in the generic drug industry, and shows how the problems of a tiny drug maker can potentially have a wide impact on the nation's prescription drug supply.

"When there is a recall, it's going to affect the entire market, depending upon the size of the company's sales," said lawyer Peter Reichertz, who works with drug companies on manufacturing issues from his office in Washington, D.C.

"Able doesn't have a blockbuster product, but they have niche products," he said. "Even though they are a small player overall, they could be a significant player in one product."

Page 2 of 3
Able was a familiar name in the pharmaceutical industry because of its fast-growing stable of products, including widely available generic versions of popular brand-name drugs for pain, inflammation, obesity, cardiovascular problems and neurological ailments. Its top seller was a generic version of the allergy tablet Promethazine.

Last year alone, Able produced 1.3 billion doses of prescription medication in nondescriptwarehouses in New Brunswick and South Plainfield.

Since the May 19 resignation of Chief Executive Dhananjay Wadekar, the company has said its product line suffered from "improper laboratory practices and noncompliance with standard operating procedures," and that some of its products may be "sub- or super-potent."


The company has repeatedly declined to answer questions about its difficulties.

Arthur Wong, a pharmaceutical analyst at Standard & Poor's, said generic drug makers buy one another's products and enter into development agreements to expand their operations on the cheap.

"How else to they expand their portfolios? Their internal research and development is not fast enough, so they license, buy, do distribution agreements, development agreements," he said. "A lot of the pharmaceutical industry is intertwined these days."

In addition to InvaGen, Able entered into a development agreement last year with the New Jersey subsidiary of Strides Arcolab, one of India's largest manufacturers and exporters of pharmaceutical products. At the same time, Able purchased raw products from suppliers in India, according to its filings with the Securities and Exchange Commission.

The recall affected medicines produced under both the Able Laboratories brand and LiquiSource, a New Brunswick manufacturer and supplier acquired by Able two years ago. It manufactured 12 difficult-to-produce liquid medications, including cough-cold products and antihistamines.

Glenn Pruitt, regulatory director at Cypress Pharmaceutical, a generic drug house in Madison, Miss., said the LiquiSource portion of the recall has generated a mountain of paperwork and expense. Cypress stopped buying Able products a year ago, he said, but the long expiration dates on LiquiSource goods means many bottles are still in circulation.

"That certainly hurt us pretty hard," he said. "It's not just the cost of the product, but a recall is expensive. The costs can run thousands and thousands of dollars. You have to pay the wholesalers, there's a lot of shipping and a lot of aggravation. Nobody wants a recall."

Recalls last year by Able -- including batches of a liquid pediatric nausea medication and tablets of the popular blood pressure medication Atenolol -- prompted Cypress to stop doing business with Able, Pruitt said.

Larry Runsdorf, president of Boca Raton-based Breckenridge Pharmaceutical, said the only drugs his company purchased from Able were LiquiSource antihistamines. IVAX, a Miami-based generic drug manufacturer, said it also purchased a significant number of goods from LiquiSource.

Both Breckenridge and IVAX said Able's recall was causing them serious financial and logistical headaches.

Reddy of InvaGen said he soon expects to get angry letters from consultants and suppliers that are owed a total of $692,000 for work related to the agreement with Able.

He recalled the satisfaction on the faces of his scientists -- lured from Genentech, Pfizer and other top pharmaceutical laboratories -- the day Able signed to bring InvaGen's first products to the marketplace.

"We don't have money to pay. Now we need more bio-studies. We don't know what to do," Reddy lamented. "We're looking for new investors, who are very difficult to find.

"Everybody is hurt because of this stupid company."



George E. Jordan may be reached at gjordan@starledger.com or (973) 392-1801.

Old IBOX just for whatever reference:

Website: http://www.ablelabs.com/





INSTITUTIONAL HOLDERS & SHORT INTEREST: (just enter 'ABRX' and click 'GO')
http://lionshares.com/details.cfm?SEARCH=symbol&CUSIP=00371N407&SID=DSUD001%2081301460419103....
http://quotes.nasdaq.com/asp/MasterDataEntry.asp?page=Short%20Interest

Shares Outstanding: 17.95 million
Float: 16 million
Book Value: 4.964/share
http://finance.yahoo.com/q/ks?s=ABRX

REVENUE (ABLE LABS ONLY):..............EARNINGS PER SHARE (split-adjusted, fully diluted): .......(taken from SEC filings and press releases)

2000: 1.3 million.......................................2000: -1.80
2001: 16.5 million.....................................2001: -.525 (-1.50 including one-time, non-cash items)
2002: 52.9 million.....................................2002: +.63 (1.44 including one-time, non-cash items)

2003:
--Q1: 15.0 million.....................................--Q1: +.06
--Q2: 18.9 million.....................................--Q2: +.14
--Q3: 20.9 million.....................................--Q3: +.13
--Q4: 22.8 million.....................................--Q4: +.13
Total: 77.6 million.............................................+.46

2004:
--Q1: 21.5 million.....................................--Q1: +.10
--Q2: 23.0 million.....................................--Q2: +.11
--Q3: 27.3million......................................--Q3: +.23
--Q4: 31.4 million.....................................--Q4: +.32
Total: 103.2 million...........................................+.75

2005:
--Q1: 30.7 million.....................................--Q1: +.24

CURRENT PRODUCTS: http://www.ablelabs.com/products/products.html

ALL PRS SINCE NOVEMBER 2000: http://www.ablelabs.com/investors/pr.html
MANAGEMENT: http://www.ablelabs.com/about/management.html
RESEARCH & DEVELOPMENT: http://www.ablelabs.com/about/rd.html

SEC FILINGS (ABRX): http://www.pinksheets.com/quote/filings.jsp?symbol=ABRX

Primary Investor Contact
Able Laboratories Investor Relations
Andreea C. Cordoba
phone: 908.754.2253 ext 664
fax: 908.754.1736
IR@ablelabs.com
http://www.ablelabs.com/investors/investors.html

INDUSTRY LINKS AND ARTICLES:
Generic Vs. Brand Name Drugs: What's The Real Difference? http://www.healthcentral.com/drdean/deanfulltexttopics.cfm?id=35609
FDA Ensures Equivalence of Generic Drugs http://www.fda.gov/fdac/special/newdrug/generic.html
FDA New and Generic Drug Approvals By Name http://www.fda.gov/cder/approval/index.htm
International Journal of Generic Drugs http://www.locum.co.il/

Thanks.

Disclaimer: We have represented all information above as objectively and accurately as possible. Opinion, including our own, is contained in the above page. Please call Jay Wadekar at 908-754-2253 for clarificiation on any of the above information. Please do not buy or sell ABRX based on this post alone. You are responsible for doing your own due diligence to confirm any of the above and to assess any other available investor information.

Good point. May be misleading now too. EOM

Raw excellent site and alot of hard work in due diligence.

But just maybe you should take this site down.
Just to see someone blame you for their abrx problems.
================================================================

excellent site, but no reason for you to become part of the vulture meat.

Able Laboratories Reports Financial Results for 2004 Fourth Quarter and Full Year
Monday March 7, 4:25 pm ET
- Net Sales Increase 38% to $31.4 Million for Q4 2004 from $22.8 Million for Q4 2003Net Sales Increase 33% to $103.2 Million for 2004 from $77.6 Million for 2003Diluted Earnings per Share Increases 146% to $0.32 for Q4 2004 from $0.13 for Q4 2003Diluted Earnings per Share Increases 63% to $0.75 for 2004 from $0.46 for 2003


CRANBURY, N.J., March 7 /PRNewswire-FirstCall/ -- Able Laboratories, Inc. (Nasdaq: ABRX - News) today announced financial results for the three months and year ended December 31, 2004.
ADVERTISEMENT


Fourth Quarter 2004 Financial Results

For the fourth quarter of 2004, the Company reported net sales of $31.4 million, a 38.2% increase from net sales of $22.8 million in the fourth quarter of 2003, primarily due to the Company's expanded product family. The Company also reported operating income of $8.5 million for the fourth quarter of 2004, a 135.6% increase compared to operating income of $3.6 million for the fourth quarter of 2003. These results included an increase in research and development expenses of $409,000, or 10.9%, compared to the fourth quarter of 2003. Diluted earnings per share increased to $0.32 for the fourth quarter of 2004 compared to diluted earnings per share of $0.13 for the fourth quarter of 2003.

(Logo: http://www.newscom.com/cgi-bin/prnh/20030721/ABLELOGO )

Gross profit was $16.5 million for the quarter, an increase of 54.7%, compared to $10.7 million for the fourth quarter of 2003. The Company's gross profit margin was 52.5%, compared to 46.9% for the fourth quarter of 2003. Gross margin increased as a percentage of net sales for the quarter primarily as a result of selling newly-approved products at higher gross margins.

Dollars invested in research and development expenses increased as a result of additional research and development conducted to further develop the Company's product pipeline and costs associated with partnering arrangements. Research and development expenses were 13.2% of net sales for the fourth quarter of 2004 versus 16.4% of net sales for the fourth quarter of 2003. The Company currently has six ANDAs pending approval by the U.S. Food and Drug Administration ("FDA") addressing a total market size of approximately $500 million. In addition, the Company has 18 projects currently under development addressing a total market size of approximately $2.6 billion.

Selling, general and administrative expenses increased to $3.8 million for the fourth quarter of 2004 compared to $3.3 million for the fourth quarter of 2003. Selling, general and administrative expenses were 12.1% of net sales for the quarter compared to 14.5% of net sales for the fourth quarter of 2003. The increase of $508,000 was primarily attributable to increased administrative, selling and marketing expenses to support the Company's growth.

Operating income for the fourth quarter of 2004 was $8.5 million, or 27.2% of net sales, versus $3.6 million, or 15.9% of net sales, for the fourth quarter of 2003. The operating income increase is attributable to increased sales and higher gross profit margins offset by the $917,000 increase in operating expenses. The effective tax rate for the fourth quarter of 2004 was 25.8% compared to an effective tax rate of 36.4% for the fourth quarter of 2003. The decrease in the effective tax rate is primarily due to the recognition of $864,000 of additional deferred income tax benefits. The recognition of the additional deferred income tax benefits increased diluted earnings per share by $0.04. Net income applicable to common stockholders for the quarter was $6.2 million versus $2.4 million for the fourth quarter of 2003. Fully diluted earnings per share increased 146.2% to $0.32 for the fourth quarter of 2004 versus the $0.13 reported for the fourth quarter of 2003.

Fiscal 2004 Financial Results

For the year ended December 31, 2004, the Company reported net sales of $103.2 million, a 33.0% increase from net sales of $77.6 million for the year ended December 31, 2003.

Gross profit was $51.8 million for 2004, an increase of 43.0%, compared to $36.2 million for 2003. The Company's gross profit margin was 50.2% for 2004, compared to 46.7% for 2003. Gross margin increased as a percentage of net sales primarily as a result of selling newly-approved products at higher gross margins.

Research and development expenses increased by $4.0 million, or 35.8%, to $15.2 million for 2004 compared to $11.2 million for 2003. Research and development expenses were 14.8% of net sales for 2004 versus 14.5% of net sales for 2003. The Company received FDA approval for 16 new products during 2004.

Selling, general and administrative expenses increased to $14.0 million for 2004 compared to $10.7 million for 2003. Selling, general and administrative expenses were 13.6% of net sales for 2004 compared to 13.8% of net sales for 2003. The increase of $3.3 million was primarily attributable to increased expenses for salaries and benefits necessary to support the Company's growth.

Operating income for 2004 was $22.5 million, or 21.8% of net sales, versus $14.3 million, or 18.4% of net sales, for 2003. The operating income increase is attributable to increased sales and higher gross profit margins partially offset by the $7.3 million increase in operating expenses. The effective tax rate for 2004 was 33.6% compared to an effective tax rate of 38.9% for 2003. The decrease in the effective tax rate is primarily due to the recognition of $864,000 of additional deferred income tax benefits. The recognition of the additional deferred income tax benefits increased diluted earnings per share by $0.04. Net income applicable to common stockholders for 2004 was $14.6 million compared to $8.2 million for 2003. Fully diluted earnings per share increased 63.0% to $0.75 for 2004 versus the $0.46 reported for 2003.

At December 31, 2004, the Company had cash and cash equivalents of $11.7 million and working capital of $52.0 million compared to cash and cash equivalents of $20.1 million and working capital of $47.1 million at December 31, 2003. During 2004, we invested approximately $24.3 million in new property and equipment.


Fourth Quarter 2004 Corporate Highlights
-- The Company promoted Nitin V. Kotak to Vice President, Finance and
Accounting. Mr. Kotak has taken over responsibility for the Company's
financial and accounting management.
-- The Company entered into a development agreement for a specialty
prescription generic drug product with Strides, Inc., NJ, a
wholly-owned subsidiary of Strides Arcolab, Limited, one of India's
largest manufacturers and exporters of pharmaceutical products.

"We achieved record sales and earnings in the fourth quarter and for the year. Supported by our 16 ANDA approvals in 2004, we have also seen increased acceptance of our products by several key customers as a result of the efforts of our sales management team," commented Jay Wadekar Chairman and CEO of Able Laboratories, Inc.

"Last year was a transition year for us as we began relocating to the new facility. We also enhanced our growth prospects by making several key additions to our management team. We are excited about our R&D plans and partnership agreements, which we believe, will provide us with opportunities for significant long term growth."

Conference Call Information

Able Laboratories has scheduled a conference call and web cast regarding this announcement to be held tomorrow, Tuesday, March 8, 2005, beginning at 10:00 a.m. Eastern Time. To participate in the live call via telephone, please call (877) 464-5947 or (706) 679-0842 internationally. A telephone replay will be available for 48 hours following the call by dialing (800) 642-1687 or (706) 645-9291 internationally and entering reservation number 4523818.

Individuals interested in listening to the conference call via the Internet may do so by visiting our web site http://www.ablelabs.com. A replay will be available on the web site for 90 days.

Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Further information on Able may be found on the Company's web site, http://www.ablelabs.com.

Except for historical facts, the statements in this news release, as well as oral statements or other written statements made or to be made by Able Laboratories, Inc., are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. For example, statements about the Company's operations, its ability to formulate and bring to market its drug products under development, its ability to increase sales and profits and manage its growth, the expected effects of the Company's expansion of its production facilities, the current or expected market size for the Company's products, the adequacy of the Company's manufacturing capacity, the availability of sufficient capital, the success of current or future product offerings, research and development efforts and the Company's ability to file for and obtain U.S. Food and Drug Administration approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company's current predictions of future events, the statements are inherently uncertain, and actual results could differ materially from the statements made herein. There is no assurance that the Company will continue to achieve the sales levels necessary to make its operations profitable or that its ANDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10- Q for the quarter ended September 30, 2004 and its Annual Report on Form 10-K for the year ended December 31, 2003. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments.


ABLE LABORATORIES, INC.
CONDENSED STATEMENTS OF INCOME
(Unaudited) Three Months Ended Year Ended
December 31, December 31, December 31, December 31,
2004 2003 2004 2003 Sales, net $31,435,989 $22,752,442 $103,193,652 $77,561,115
Cost of sales 14,918,772 12,073,554 51,433,991 41,355,192
Gross profit 16,517,217 10,678,888 51,759,661 36,205,923 Operating expenses:
Selling, general
and administrative 3,817,648 3,309,216 14,001,498 10,696,864
Research and
development 4,150,400 3,741,320 15,231,815 11,212,418
Total operating
expenses 7,968,048 7,050,536 29,233,313 21,909,282 Operating income 8,549,169 3,628,352 22,526,348 14,296,641 Other income (expense):
Interest and
financing expense (37,737) (54,378) (188,463) (543,849)
Loss on early
retirement of debt ---- ---- (118,440) (241,999)
Miscellaneous income
(expense), net (190,128) 250,236 (144,612) 388,755
Other income
(expense), net (227,865) 195,858 (451,515) (397,093) Income before
income taxes 8,321,304 3,824,210 22,074,833 13,899,548
Provision for
income taxes 2,144,000 1,393,900 7,423,000 5,412,000
Net income 6,177,304 2,430,310 14,651,833 8,487,548 Dividends on
preferred stock 11,712 42,090 89,642 274,559
Net income
applicable
to common
stockholders $6,165,592 $2,388,220 $14,562,191 $ 8,212,989 Net income per share:
Basic $0.34 $0.14 $0.84 $0.56
Diluted $0.32 $0.13 $0.75 $0.46 Weighted average
shares outstanding:
Basic 17,983,452 16,536,986 17,401,740 14,709,040
Diluted 19,571,168 19,301,487 19,433,451 18,374,894 ABLE LABORATORIES, INC.
CONDENSED BALANCE SHEETS
(Unaudited) ASSETS
December 31, December 31,
2004 2003
Current assets:
Cash and cash equivalents $11,650,886 $20,065,248
Accounts receivable, less allowances
of $38,272,886 and $24,007,583 17,878,380 8,626,023
Inventory 18,105,275 16,602,608
Deferred income tax asset 7,500,000 4,760,000
Prepaid expenses and other current assets 1,843,882 1,644,068
Total current assets 56,978,423 51,697,947 Property and equipment, net 40,228,942 18,953,744 Other assets:
Debt financing costs,
net of accumulated amortization --- 91,708
Cash deposits with bond trustee --- 525,907
Deferred income tax asset 2,743,000 9,709,000 Goodwill 3,922,655 3,904,094
Deposits and other assets 418,082 481,755
Total other assets 7,083,737 14,712,464
$104,291,102 $85,364,155 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities:
Notes payable and current portion
of long-term debt $--- $239,038
Accounts payable 2,742,823 3,293,168
Accrued expenses 2,268,763 1,114,976
Total current liabilities 5,011,586 4,647,182
Long-term debt, less current portion 3,000,000 3,935,000
Total liabilities 8,011,586 8,582,182 Stockholders' equity:
Preferred stock, $.01 par value,
10,000,000 shares authorized, none
and 17,025 shares of Series Q
outstanding (liquidation value
$1,702,500 at December 31, 2003) --- 171
Common stock, $.01 par value,
25,000,000 shares authorized,
18,353,281 and 16,761,216 shares
issued and outstanding 183,532 167,611
Additional paid-in capital 120,804,537 116,060,210
Accumulated deficit (24,644,108) (39,295,941)
Unearned stock-based compensation (64,445) (150,078)
Total stockholders' equity 96,279,516 76,781,973
$104,291,102 $85,364,155 Company Contacts:
Jay Wadekar, Chairman & CEO
Nitin V. Kotak, Vice President, Finance and Accounting
Phone (609) 495-2800 Investor Contact:
Investor Relations
Phone (609) 495-2805
Email: IR@ablelabs.com




--------------------------------------------------------------------------------
Source: Able Laboratories, Inc.

ABRX TO $30 CONTEST

Time supplied is for use as a tie-breaker (if equal number of TRADING days off). If no time is supplied, 12:45pm will be entered. After hours and premarket trading does not qualify.

01/10/05 - 10:45am...........ThePillOne (AOL)
01/21/05 - 11:22am...........sir_charles_of_telecom (yahoo)
02/10/05 - 03:35pm...........Lowballhitter (yahoo)
03/01/05 - 12:45pm...........yrrej35 (yahoo)
03/17/05 - 11:45am...........dewars1313 (yahoo)
04/01/05 - 11:30am...........macromny (RB)
04/03/05 - 12:00pm...........bpipes8810 (RB)
04/16/05 - 12:45pm...........drugmanrx (RB)
04/25/05 - 10:17am...........drumshd (Yahoo)
04/29/05 - 12:30pm...........HEYROXANNE (AOL)
05/06/05 - 02:30pm...........mikelimeo (yahoo)
05/07/05 - 01:10pm...........R2BKnight (AOL)
05/12/05 - 10:30am...........rwpauli (RB)
05/17/05 - 01:30pm...........rawnoc05 (yahoo)
05/18/05 - 10:00am...........harry7422 (RB)
05/19/05 - 12:45pm...........FCJR1 (AOL)
05/23/05 - 12:45pm...........Stockwhiz (AOL)
05/25/05 - 11:00am...........dante6249 (RB)
06/06/05 - 10:30am...........sleestack76 (yahoo)
06/16/05 - 10:20am...........Laura5969 (AOL)
08/02/05 - 11:00am...........stockmaster4ever (RB)
08/13/05 - 09:45pm...........bobsagetfanatic (yahoo)
10/10/05 - 09:00am...........JBird10000 (RB)
10/31/05 - 10:14pm...........paisano42 (Investorshub.com)
09/01/06 - 12:45pm...........shortonabrx (yahoo)
never........................Asxykitten23 (AOL)

Raw

Able Laboratories "buy," target price raised

Wednesday, November 03, 2004 9:41:54 AM ET
First Albany


NEW YORK, November 3 (newratings.com) - Analysts at First Albany reiterate their "buy" rating on Able Laboratories (ABRX.NAS). The target price has been raised from $25 to $27.

Most popular stories:
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In a research note published this morning, the analysts mention that the company reported its Q3 EPS marginally ahead of the estimates and the consensus. The upside during the quarter was driven by higher-than-expected sales from Able Laboratories' new products, the analysts say. The company is expected to file 15-to-20 ANDAs by 1H05, First Albany adds.

Hi Raw!

I couldn't believe it when I first saw it. If this stock hits 25 by next quarter, it is an easy double in the option price, imo. You get more bang for less money than buying the stock itself. Not good for writing options though, lol!

Hmmmm...interesting. Thanks.

Raw

I picked up June 17.50 calls for 3.50 a few days ago. Only 4X4.40 today, unbelievable. Already 3 bucks in the money and only 1 buck to pay for over 8 months. Why are people not looking at this option if anybody believes this stock will hit 25 or more by first quarter next year? Sometimes, I don't understand it!

thank you EOM

10/31/05 10:14 pdt

ABRX TO $30 CONTEST - contest extended one week.

Entry due by Monday, Nov 15th, 9:30am EST via e-mail or post.

Rules - only one person may pick any one date and only one date

per person. Supply a time as a tie-breaker (if equal number of

TRADING days off). If no time is supplied, 12:45pm will be

entered. After hours and premarket trading does not qualify.

01/21/05 - 11:22am...........sir_charles_of_telecom (yahoo)
02/10/05 - 03:35pm...........Lowballhitter (yahoo)
03/01/05 - 12:45pm...........yrrej35 (yahoo)
03/17/05 - 11:45am...........dewars1313 (yahoo)
04/03/05 - 12:00pm...........bpipes8810 (RB)
04/16/05 - 12:45pm...........drugmanrx (RB)
04/25/05 - 10:17am...........drumshd (Yahoo)
04/29/05 - 12:30pm...........HEYROXANNE (AOL)
05/06/05 - 02:30pm...........mikelimeo (yahoo)
05/17/05 - 01:30pm...........rawnoc05 (yahoo)
05/19/05 - 12:45pm...........FCJR1 (AOL)
05/23/05 - 12:45pm...........Stockwhiz (AOL)
06/06/05 - 10:30am...........sleestack76 (yahoo)
06/07/05 - 03:00pm...........R2BKnight (AOL)
08/02/05 - 11:00am...........stockmaster4ever (RB)
08/13/05 - 09:45pm...........bobsagetfanatic (yahoo)
09/01/06 - 12:45pm...........shortonabrx (yahoo)

Raw

FINALLY listened to the July earnings conference call....Jay still saying "assuming blah blah blah"... $105 million in sales for 2004.

44.5 million so far for 2004. So he's expecting $60.5 million possibly for Q3 and Q4?

That's an average of $30.25 mil per Q which appears to be a monster jump from latest reported levels.

NICE

Warming up my ABRX trading fingers as well as considering adding to my long term shares soon.

Raw

We really appreciate the input from board members, especially Rawnocs updated DD pages.

Raw - DYNT

I hope it recovers soon and lets you out unscathed. For me, since I don't like betting, I stayed out.

Happy trading.

OT: DYNT....oops. For the moment at least. EOM

Raw, I thought I knew you, since I've been reading the ABRX board on RB in the past and sometimes found you here around. I got interested in DYNT through your DD, actually. That's why I didn't expect to see you buying something out of boredom. Ok for intuition, while that's not DD either. But maybe you were joking and I didn't understand it.

Again, good luck to all of us.

You must not know me very well. EOM

Well, I hope boredom and intuition are not the only pillars of your regular DD.

Good luck to all of us.

The strongest technical fact, regarding DYNT, is the region at 2.00/2.15. It acted as support for a few weeks on the way down, then was confirmed as resistance in July and by its recent top at 1.98. Now 200 MA is flat at 2.15, while 100 MA is just crossing it to the downside. All in all, quite a strong barrier. It won't be easy to get back into the 2s and stay there, IMO.

Being a technical trader, my opinions concern its stock's behavior, which I don't like. I don't like its poor volume, its mad spikes, the aggressive selling at every climb. I've looked for fresh informations, but couldn't find any, so I've no idea whatsoever if they're selling their lasers or not. Since they'll announce during the market and not suddenly, like last time, I suppose they'll have good news to report. Will they be such as to bring its price back into the 2s, at least, and keep it there?

Why am I following it, then, if I don't like it? A youth folly made me buy some at a higher price, but I wasn't quick enough to get out. Actually, on paper I even liked their business.

Happy trading.

Honestly, I'm way behind on my DD on basically the entire stock market right now. No idea what to expect, but if I get a moment, I would love to DD DYNT's latest and possibly load up, if my DD says to, before earnings!

Any opinion you have would be appreciated by me. TIA.

Raw

Raw, any comment on what to expect out of DYNT? They're reporting on Thursday at 10 AM. Do you see a good sign in their reporting during market?

OT: Still long, getting impatient, added recently but done adding.

Raw

OT

RAW ARE STILL very bullish on ( UIBI )

THANK IN ADVANCE

OT: Was watching it today and yesterday. Nice bounce, but I'm staying away.

Raw

OT RAW what is opinion of ( bocx )

Tried to post on RB unsuccessfully. Had nothing to say really except that no one was posting despite 50 cent rise in stock price. Now I realize it's because you can't post. :)

Words of the drug trade

Patent - the right to exclude others from making, using, offering for sale, or selling.

Exclusivity - exclusive marketing rights granted by the Food and Drug Administration (FDA) upon approval of a drug.

Bioequivalent - The active ingredients in a generic drug must be absorbed at a similar rate and in a similar amount as the brand name drug. The generic does not have to act exactly the same as the brand name drug, but it does have to fall within certain guidelines set by the FDA. These guidelines may vary from drug to drug.

Generic Drug - Generic drugs must have the same active ingredients as the name brand, but the inactive ingredients could be different. Inactive ingredients may include colors, preservatives, or other fillers. However, just because a generic has the same inactive ingredients it is not automatically considered a generic equivalent.

Health Insurers using coupons for generic drugs.


This is something I did not know. Some health insurers issue generic drug coupons to plan participant doctors to give to their patients.

I know how to move this stock from the pits it is in. I will sell and move on and then I can guarantee you people that it will move up, lol. I am almost there. Fed up with it as it is gradually turning into a semi-pos, lol. Have lots of money tied into it. This and cygx are are giving me the blues, lol. I was hoping to make a killing with these two at this time. Oh well!

ABRX leveled chart.

If one looks at the all the insider sales since August 03. It may explain the downside to a leveling stall.

News has been mighty short of late. Generic approvals are not rapidly expanding as in the past.

But to the industry shelf space. ABLE has taking shelf space in huge numbers. ABle is a highly popular generic brand name within the industry.

To Raw:

You are in touch with Jay. What is happening? They have not released anything for a month.

Rawnoc = Thank you.