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La Jolla Pharma axes plan to dissolve company
La Jolla says it could not get shareholder support for dissolution, and will find alternatives
* On 4:56 pm EST, Wednesday November 25, 2009
o La Jolla Pharmaceutical Co.
SAN DIEGO (AP) -- La Jolla Pharmaceutical Co. said Wednesday its shareholders did not support a proposal to dissolve the company, and it will consider other options.
La Jolla said it is evaluating its options and will announce future plans after it determines the best way to obtain value for its shareholders.
The company proposed its dissolution in October, but has been unable to get a majority of shareholders to support the idea. It convened several shareholder meetings in November to try to gather the votes, but said 92 percent of shareholders still had not voted.
In February, La Jolla and its partner BioMarin Pharmaceutical stopped a trial of a lupus drug called Riquent, which La Jolla had developed. Reviewers determined the drug was not working. La Jolla was not testing any other products and had no approved drugs on the market. Last month, the company said it had completely written off the value of its Riquent assets and would not maintain the patents or any other spending related to Riquent.
La Jolla said it owed $4.4 million as of Aug. 31, and it had no other drugs in development or products on the market.
La Jolla shares closed at about 7.7 cents on Wednesday.
Dan,
IMO in the next few years, we'll be seeing additional Inca retail stores open up across the US as the brand grows. Agree?
JMO.
GLTA!
Most pinks move on hype, not numbers. Look @ BEHL when it had it's run earlier. Look @ PDMI (went from .002-.007 a while back). Look @ ASFX, EXPH, etc...
JMO.
GLTA!
Ok Incans, let's slap that .013 ask some more and close green for the day!
GLTA!
Ask just slapped @ .013! I had a few bucks left over to add some more.
GLTA!
GO IDGI!
I ended up slapping the ask @ .014, fyi.
GLTA!
I just put in an order for .0115. Maybe I'll get filled. :)
IVD currently has a 510k in w/ FDA. Could possibly be a nice jump in price if approved. However, in the 3Q earnings, the company announced that the FDA has requested extra info before they can approve the device.
http://finance.yahoo.com/news/IVAX-Diagnostics-Diamedix-bw-4275284540.html?x=0&.v=1
JMO.
GLTA!
11/12/2009 -- IVAX Diagnostics, Inc. Reports Third Quarter 2009 Financial Results
--Anticipated Realignment of Sales Force and New Product Introductions Expected to Favorably Impact 2010 Results--
* Press Release
* Source: IVAX Diagnostics, Inc.
* On 10:15 am EST, Thursday November 12, 2009
MIAMI--(BUSINESS WIRE)--IVAX Diagnostics, Inc. (AMEX: IVD - News), a fully integrated in vitro diagnostics company, reports its financial results for the third quarter and nine months ended September 30, 2009.
Charles Struby, Ph.D., Chief Executive Officer and President of IVAX Diagnostics, said, “Since the beginning of the year we have been focused on building a stronger organization, taking the necessary actions to strengthen our revenue and improve our operating results. Planning for the expected launch next year of our new product lines stemming from the distribution agreement we signed with IMMCO Diagnostics in July, includes realignment of our U.S. sales force, and preparations for an intensive product promotion campaign to support the sales of our new products. Those new products will more than double the number of Autoimmune ELISA (Enzyme-linked Immunosorbent Assay) test kits and add 50 new IFA (Immunoflourescence Assays) test kits to our product line. During September we received our first orders for the Simtomax® Blood DropTest, a new product for the detection of celiac disease that we obtained the right to distribute under our recently signed distribution agreement with Augurix SA.”
“As previously announced, we submitted a 510(k) premarket submission with the U.S. Food and Drug Administration (FDA) for the MAGO® 4S, our next-generation fully automated Enzyme-linked Immunosorbent Assay (ELISA) system for autoimmune and infectious disease testing. We believe the new instrumentation will provide a flexible, efficient and cost-effective solution to today’s high-performance laboratory demands. We filed this 510(k) submission on September 30, 2009, which was well in advance of our previously announced goal of making that submission prior to year-end. We have received feedback from the FDA requesting that we provide additional analytics and clinical test data, and are working with them to provide the requested information and expedite the approval process. We remain hopeful that we can achieve our previously announced goal of receiving regulatory approval during the first quarter of 2010 and, in any event, expect to receive regulatory approval during the first half of 2010,” Dr. Struby continued.
“Since the beginning of the year we have laid the groundwork to make our company stronger and more efficient, through a thorough evaluation of our operations, our distribution agreements, manufacturing facilities and product offerings. It has been a challenging year in many ways, from both a macro and micro standpoint. While the IVAX Diagnostics team cannot impact world economic conditions, we believe the steps we are taking to improve our operations and competitiveness, while increasing our footprint in the global in vitro diagnostics market, will have beneficial effects for both our customers and stockholders alike. We believe these improvements will help improve our company’s long-term performance in our growing marketplace,” Dr. Struby added.
Financial Highlights for the Quarter and Nine Months Ended September 30, 2009
Net revenues for the third quarter of 2009 were $4.6 million, compared with $5.4 million in the third quarter of 2008. While domestic revenues for the third quarter of 2009 were relatively consistent with domestic revenues achieved during the first and second quarters of 2009, net revenues from domestic operations comprised $717,000 of the year-over-year quarterly overall decrease in net revenues. Italian revenues declined by $138,000, of which $79,000 was due to the fluctuation of the United States dollar relative to the Euro. As measured in Euros, Italian revenues for the third quarter of 2009 decreased 4.8% compared to Italian revenues generated in the same period of 2008, principally due to relatively small reagent and instrumentation sales declines to the company’s international distributors. Domestic revenue was affected by declines in reagent sales to instrumentation customers, as well as decreases in contract manufacturing revenue and antigen sales. Global economic conditions continued to adversely affect revenues in both segments of the company’s business.
Gross profit for the third quarter of 2009 was $2.4 million compared with $3.2 million in the third quarter of 2008. Gross profit margins were 53.3% for the third quarter of 2009 compared with 59.9% in the same period of 2008. The decrease in gross profit was primarily attributable to the decline in net revenues, including the effect of exchange rate fluctuations, and the decrease in gross profit margins was principally the result of a decline in domestic gross profit due to an increase in domestic manufacturing costs and unfavorable manufacturing variances.
Operating expenses for the third quarter of 2009 were $3.5 million compared with $3.2 million in the third quarter of 2008. Contributing to this increase was an increase in domestic selling expenses resulting from increased travel costs as well as consulting fees incurred in the company’s comprehensive review of its business plans and operations. General and administrative costs also increased, primarily as a result of the review of the company’s business plans and operations, as well as a bad debt recovery in Italy in 2008 that reduced expenses during that period. Partially offsetting these increases were declines in compensation costs and professional fees incurred in connection with the company’s change of control transaction in 2008, and a decline in board of director compensation from the quarter ended September 30, 2008. Research and development costs increased slightly. Included in current year expenses are costs incurred in connection with the company’s 510(k) premarket submission to the FDA for its MAGO® 4S as well as development costs for this instrumentation system.
Loss from operations was $1,117,000 during the third quarter of 2009 compared to income from operations of $6,000 in the third quarter of 2008. Loss from operations in the third quarter of 2009 was composed of a loss from domestic operations of $667,000 and loss from Italian operations of $454,000. Income from operations in the third quarter of 2008 was composed of income from domestic operations of $156,000 partially offset by a loss from Italian operations of $145,000. Included in the company’s domestic operations are corporate expenditures, such as costs required to maintain its status as a public company.
Net loss for the third quarter of 2009 was $1.2 million, or $0.04 loss per share, compared with net income of $19,000, or $0.00 earnings per share, in the third quarter of 2008.
For the nine months ended September 30, 2009, net revenue was $13.9 million compared with $16.0 million in the same period of the prior year. Domestic revenues for the nine months ended September 30, 2009 were $9.6 million compared with $10.8 million in the same period of the prior year, and Italian revenue for the nine months ended September 30, 2009 was $4.3 million compared to $5.2 million same period of the prior year. Gross profit for the nine months ended September 30, 2009 was $7.7 million compared with $9.7 million in the same period of the prior year. Gross profit margins for the nine months ended September 30, 2009 were 55.1% compared with 60.5% in the same period of the prior year. Operating expenses for the nine months ended September 30, 2009 was $10.8 million compared with $9.2 million in the same period of the prior year. Loss from operations for the nine months ended September 30, 2009 was $3.1 million compared to income from operations of $484,000 in the same period of the prior year. Net loss for the nine months ended September 30, 2009 was $3.1 million, or $0.11 loss per share, compared to net income of $661,000, or $0.02 earnings per share, in the same period of 2008.
Dr. Struby concluded, “IVAX Diagnostics’ improving diagnostic capabilities and expanded product line, our solid reputation in the marketplace and debt-free balance sheet, we believe, help position the company to capitalize on the positive trends in the marketplace. With the continued aging of the global population and the increased role that disease management is playing in the healthcare industry, we look forward to taking advantage of the many opportunities that are ahead of us.”
About IVAX Diagnostics, Inc.
IVAX Diagnostics, Inc. (www.ivaxdiagnostics.com), headquartered in Miami, Florida, is a fully integrated in vitro diagnostics company that develops, manufactures and distributes in the United States and internationally, proprietary diagnostic reagents, test kits and instrumentation, primarily for autoimmune and infectious diseases, through its three subsidiaries: Diamedix Corporation, Delta Biologicals S.r.l. and ImmunoVision, Inc.
Safe Harbor Statement
Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect the business and prospects of IVAX Diagnostics, Inc., including, without limitation: the risks and uncertainties associated with IVAX Diagnostics’ strategic initiatives, including, without limitation, that IVAX Diagnostics’ anticipated realignment of its sales force and introduction of new products may not result in improved operating results for IVAX Diagnostics or otherwise positively impact its financial condition or cash position, that IVAX Diagnostics’ efforts since the beginning of the year may not result in a stronger organization, result in a more efficient company, strengthen its revenue or improve its operating results, financial condition or cash position, that IVAX Diagnostics may not improve its operations and competitiveness or increase its footprint in the global in vitro diagnostics market, and that IVAX Diagnostics’ strategic initiatives may not have beneficial effects for its customers or stockholders or otherwise improve IVAX Diagnostics’ long-term performance; the risks and uncertainties associated with IVAX Diagnostics’ distribution agreement with IMMCO Diagnostics, including, without limitation, that IVAX Diagnostics’ anticipated realignment of its sales force and intensive product promotion campaign may not establish the foundation or support necessary for the successful launch of new product lines from IMMCO Diagnostics under such agreement, that such agreement may not be an important element in IVAX Diagnostics’ growth, result in improved operating results for IVAX Diagnostics or otherwise positively impact IVAX Diagnostics’ financial condition or cash position, that some or all of the tests and products covered by such agreement may not be well received in the markets covered by the agreement or otherwise offer the anticipated benefits that IVAX Diagnostics believes they offer, that IVAX Diagnostics may not begin distributing IMMCO Diagnostics’ test kits in the time frame anticipated, or at all, that such agreement may not result in the successful expansion of IVAX Diagnostics’ suite of ELISA or IFA test kits or, if it does so result in the expansion of IVAX Diagnostics’ suite of ELISA or IFA test kits, that such expansion will not result in improved operating results for IVAX Diagnostics or otherwise positively impact IVAX Diagnostics’ financial condition or cash position, and that IVAX Diagnostics may not generate the revenue, gross profits or gross profit margins from its distribution of IMMCO Diagnostics’ test kits in the amounts or in the time frame anticipated, or at all; the risks and uncertainties associated with the MAGO® 4S, including, without limitation, that IVAX Diagnostics may not submit the entirety of the required regulatory filings relating to the instrument, and any additional information which may be requested by regulatory authorities, when expected, or at all, that IVAX Diagnostics may not receive regulatory approval for the instrument when expected, or at all, that the instrument may not be available when expected, or at all, that IVAX Diagnostics may not successfully market the instrument, that IVAX Diagnostics’ customers may not integrate the instrument into their operations and that the instrument may not perform as expected, be a source of revenue growth for IVAX Diagnostics, be a factor in IVAX Diagnostics’ growth, expand the menu of test kits that IVAX Diagnostics offers or result in improved operating results for IVAX Diagnostics or positively impact IVAX Diagnostics’ financial condition or cash position; the risks and uncertainties associated with existing global economic conditions, including, without limitation, that IVAX Diagnostics’ operating results, and net revenues in particular, may continue to be adversely impacted if existing global economic conditions do not improve and that any such impact may be significant and have a long-term effect on IVAX Diagnostics and its financial condition, operating results and cash position; the risk that IVAX Diagnostics may not successfully implement operational improvements to help support its future growth; the risk that IVAX Diagnostics may not be able to take advantage of opportunities which may be presented by the continued aging of the global population and the increased role that disease management is playing in the health care industry or otherwise capitalize on positive trends in the marketplace; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risks and uncertainties set forth above, investors should consider the economic, competitive, governmental, technological and other risks and uncertainties discussed in IVAX Diagnostics’ filings with the Securities and Exchange Commission, including, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in such filings.
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Period Ended September 30, Three months Nine months
2009 2008 2009 2008
Net revenues $ 4,561,595 $ 5,416,859 $ 13,941,783 $ 16,022,055
Cost of sales 2,129,634 2,173,309 6,263,883 6,334,910
Gross profit 2,431,961 3,243,550 7,677,900 9,687,145
Operating expenses:
Selling 1,419,940 1,259,097 4,190,270 3,740,292
General and administrative 1,673,326 1,550,332 5,311,766 4,146,296
Research and development 456,130 428,374 1,281,818 1,316,799
Total operating expenses 3,549,396 3,237,803 10,783,854 9,203,387
Income (loss) from operations (1,117,435 ) 5,747 (3,105,954 ) 483,758
Other income:
Interest income 3,369 25,540 16,368 165,345
Other income (expense), net (1,476 ) 18,965 68,826 108,372
Total other income, net 1,893 44,505 85,194 273,717
Income (loss) before income taxes (1,115,542 ) 50,252 (3,020,760 ) 757,475
Provision for income taxes 41,428 31,289 111,112 96,136
Net income (loss) $ (1,156,970 ) $ 18,963 $ (3,131,872 ) $ 661,339
Net income (loss) per share
Basic and diluted $ (0.04 ) $ 0.00 $ (0.11 ) $ 0.02
WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING:
Basic 27,649,887 27,649,887 27,649,887 27,649,887
Diluted 27,649,887 27,649,887 27,649,887 27,649,887
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2009 2008
ASSETS
Current assets:
Cash and cash equivalents $ 4,737,133 $ 4,420,900
Marketable securities - 4,100,000
Accounts receivable, net of allowances for doubtful
accounts of $365,858 in 2009 and $358,268 in 2008 6,125,790 5,789,901
Inventories, net 5,023,862 4,678,069
Other current assets 240,708 271,069
Total current assets 16,127,493 19,259,939
Property, plant and equipment, net 1,858,873 1,848,637
Equipment on lease, net 631,932 210,743
Product license 682,936 682,936
Goodwill, net 870,290 870,290
Other assets 183,367 175,523
Total assets $ 20,354,891 $ 23,048,068
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 931,797 $ 698,693
Accrued license payable 146,165 140,062
Accrued expenses and other current liabilities 2,788,295 3,116,755
Total current liabilities 3,866,257 3,955,510
Other long-term liabilities:
Deferred tax liabilities 285,819 238,200
Other long-term liabilities 1,076,893 902,551
Total other long-term liabilities 1,362,712 1,140,751
Commitments and contingencies
Shareholders’ equity:
Common stock, $0.01 par value, authorized 50,000,000 shares,
issued and outstanding 27,649,887 in 2009 and 2008 276,498 276,498
Capital in excess of par value 41,211,079 41,065,840
Accumulated deficit (26,145,805 ) (23,013,933 )
Accumulated other comprehensive loss (215,850 ) (376,598 )
Total shareholders’ equity 15,125,922 17,951,807
Total liabilities and shareholders’ equity $ 20,354,891 $ 23,048,068
Contact:
IVAX Diagnostics, Inc.
Dr. Charles R. Struby, CEO & President
305-324-2300
or
Investor Relations:
Porter, LeVay & Rose, Inc.
Linda Decker, Vice President
212-564-4700
Looks promising, imo.
Bid building @ .0965. Ask @ .0975.
GLTA!
We've closed over $1 for 10 days straight by now, correct?
Buying pressure takes us over .10, imo...
JMO.
GLTA!
Got some shares just now in anticipation of the hearing..
GLTA!
Wow. Nice call!
GLTY.
DARA BioSciences Presented Results of Its Phase 2 Study for KRN5500 at the "12th International Conference on the Mechanisms and Treatment of Neuropathic Pain"
KRN5500 Demonstrated Significant Reduction in Pain and Superior Performance vs. Placebo
RALEIGH, N.C., Nov. 23, 2009 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA - News), a biopharmaceutical development company, presented clinical data results for KRN5500, its lead compound for Neuropathic Pain, which achieved its primary endpoint of pain reduction and demonstrated superior performance vs. Placebo (p=0.03). These study results were presented at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, held November 19-21, 2009 in San Francisco.
Sharon M. Weinstein, MD, a leading investigator in the study, presented a poster entitled "KRN5500 Demonstrates Significant Reduction in Neuropathic Pain Intensity in Patients with Cancer." The presentation provided an overview of the results from the recently completed multicenter, placebo-controlled, blinded, randomized, parallel group study designed to evaluate the safety and efficacy of KRN5500 in patients with neuropathic pain and advanced cancer. In this study KRN5500 demonstrated clinical proof of concept by meeting the primary efficacy endpoint of pain reduction.
Dr. Weinstein is a physician at the University of Utah and Huntsman Cancer Institute in Salt Lake City, UT, and is a Fellow in the American Academy of Hospice and Palliative Medicine (FAAHPM).
"Chemotherapy-induced neuropathic pain occurs in approximately 40% of patients treated with polychemotherapy and often responds poorly to presently available pain medications. Based on these positive results, DARA plans to commence a Phase 2b study in 2010," said Linda Jett, MSN, RN, leader of the pain program at the Company.
"With two drug candidates in the clinic and collaboration with America Stem Cell, DARA is poised for an exciting and productive 2010," said Richard Franco, CEO.
Additional information about the conference can be found at http://www.neuropathicpain.org/.
About DARA BioSciences, Inc.
DARA BioSciences, Inc. is a Raleigh, North Carolina based development-stage biopharmaceutical company that acquires promising therapeutic small molecules and develops them through proof of concept in humans for subsequent sale or out-licensing to larger pharmaceutical companies. Presently DARA has two drug candidates with cleared IND's (Investigational New Drug) Applications from the US FDA. One of these drug candidates KRN5500 has successfully completed a Phase 2a clinical trial treating cancer patients for neuropathic pain. It has a portfolio of drug candidates for neuropathic pain, type 2 diabetes, and psoriasis. For more information please contact the Company at 919-872-5578 or visit our web site at http://www.darabio.com.
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, risks and uncertainties relating to the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to develop and bring new products to market as anticipated, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property, the intellectual property of others, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward -looking statements contained herein to reflect an y change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.
From the Nov. 10 earnings release:
"Our third quarter results reflect our continued efforts to carefully manage and deploy our cash in what remains an uncertain financing environment," said Brian M. Culley, Principal Executive Officer at ADVENTRX. "We estimate that the net proceeds from the financing we completed on October 9, together with our cash at September 30, will support our operations well into 2010 and, importantly, through the significant milestone of an FDA decision on ANX-530."
From the information I've gathered, ANX-530 (if approved) would be entering a $200 million market.
GLTA!
NDA should be submitted by EOY, according to the CEO.
GLTA!
Yeah, they got some pretty good news today, imo.
BTW, have you seen ANX? They're trading near their 52-wk low. I picked up some shares today.
GLTY!
Just got in today...
GLTA!
Yup, I agree 100%. DARA is in a great position right now. Sadly, I didn't have enough cash to add as many as I would've liked when it was in the .30s...
GLTA!
Hey everyone, what are we possibly looking at for PPS tomorrow?
GLTA!
ONE MM left @ .019!
GLTA!
8PM I believe...
GLTA!
2 MMs left @ .018...
GLTA!
LOL wow....
GLTA!
No, I don't play ball. :/ I haven't been to the Longhorn Steakhouse, let me know if it's good!
CAB looks pretty promising, I'll definitely put it on watch!
One you might want to watch is HEPH. They have a pretty promising prostate cancer drug, in my opinion. Currently trading under $1.
GLTY!
I'm holding all of my shares as well. Not selling for less than .07-.10
GLTA!
If they're right on one coming Monday... KABOOM!!
JMO.
GLTA!
GO IDGI!
IMO just some early profit taking... Crazy, why would you take profits on IDGI now? When they've got their first PR in over a year?
GLTA!
Anyone care to take out NITE @ .0197?
GLTA!
NEWS!!!!!!
GO IDGI!
We have .02!!!
3 MMs left @ .02!
GO IDGI!!!
GLTA!
NITE back at ask for .0199
GLTA!
12PM w/ PR.
GLTA!
Good morning Incans!
GLTA!
Yeah. DARA is going over $1 sometime... It may be a few months, but IMO it'll get there.
GLTY!
Hope you can get back your losses!!
GLTY!