mlkrborn
12 years ago
Wider-than-Expected Loss at Optimer
ZacksBy Zacks Equity Research | Zacks – 5 hours ago
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Optimer Pharmaceuticals Inc.’s (OPTR) first quarter 2013 net loss (excluding special items) of 65 cents per share was wider than the Zacks Consensus Estimate of a loss of 42 cents but narrower than the year-ago loss of 73 cents per share. Lower-than-expected revenues were primarily responsible for the wider-than-expected loss incurred by the company in the first quarter of 2013.
Revenues in the first quarter of 2013 came in at $19.4 million, up 35.1% from the year-ago quarter. The increase was primarily due to higher Dificid sales. Revenues, however, missed the Zacks Consensus Estimate of $21 million.
Quarter in Details
Revenues in the reported quarter included Dificid sales in the US and Canada along with contract revenue of $2.5 million under the company’s collaboration agreements with companies like Astellas Pharma, Inc. (ALPMY), AstraZeneca (AZN) and Specialized Therapeutics Australia, Pty. Ltd.
We remind investors that Dificid, Optimer’s sole marketed product, was launched in the US in Jul 2011 for treating patients suffering from clostridium difficile-associated diarrhea (:CDAD) -- the most common form of nosocomial, or hospital acquired, diarrhea. Dificid was launched in Canada in Jun 2012. Net sales of the drug shot up 16.7% to $16.8 million in the reported quarter. The increase was primarily attributable to higher demand along with a 5.6% price increase which was effective from Jan 2013.
Dificid was approved in the EU under the trade name, Dificlir, in Dec 2011. Last month the drug was also approved in Australia for the treatment of confirmed clostridium difficile infection (CDI) in adults. Dificid is expected to be launched in Australia shortly.
We note that Optimer has an exclusive two-year agreement (through Jul 2013) with Cubist Pharmaceuticals (CBST) to co-promote Dificid in the US for the treatment of CDAD. Co-promotion expenses amounted to $3.8 million during the first quarter of 2013, compared with $10.1 million in the year-ago quarter.
Optimer is planning to expand Dificid’s label. The company is currently running a phase IIIb study evaluating the prophylactic use of Dificid in patients undergoing bone marrow transplantation or hematopoietic stem cell transplant. Optimer expects an interim analysis on the study in the latter half of the year. Optimer is also conducting a phase IIa study evaluating the pharmacokinetics of Dificid in pediatrics.
Selling, general and administrative (SG&A) expenses during the reported quarter were up 33.2% to $34 million. However, research & development (R&D) expenses were down 10.7% to $9.9 million during the period.
Optimer currently carries a Zacks Rank #4 (Sell). Meanwhile, Cubist Pharma carries a Zacks Rank #2 (Buy).
surf1944
12 years ago
8:03AM Optimer Pharma shows age has a significant effect on outcomes in patients being treated for clostridium difficile infection (OPTR) 11.86 : Results of the analysis showed that DIFICID and vancomycin were comparably effective in attaining clinical cure in all age groups studied; in those younger than 40 years of age, clinical cure was achieved in 97.2% of patients and in those older than 80, clinical cure was achieved in 87.5% to 88.2% of patients. For patients who achieved clinical cure, DIFICID-treated patients were half as likely to have had a recurrence compared to patients treated with vancomycin (OR=0.46, 95% CI [0.32, 0.67], p<0.001). The analysis showed the probability of sustained clinical response nearly doubled among DIFICID-treated patients compared to patients who received vancomycin (OR=1.86, 95% CI [1.40, 2.47], p<0.001). When researchers conducted an analysis adjusting for age and other factors that may impact treatment outcome, including the administration of concomitant antibiotics and C. difficile strain, DIFICID was associated with a 60% lower risk of recurrence (p<0.001) compared to vancomycin.
surf1944
12 years ago
8:08AM Optimer Pharma estimates DIFICID gross sales in the United States and Canada for the three months ended Dec 31, 2012 were $21.3 mln, an increase of over 14.4% versus the prior quarter (OPTR) 9.25 : Co provided an update on 2012 sales for DIFICID (fidaxomicin) tablets, an antibacterial drug launched in July 2011 for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age or older in the United States. Preliminary 2012 gross product sales in the United States and Canada totaled $74.4 million. Preliminary gross product sales for the fourth quarter of 2012 were $21.3 million in the United States and Canada.
"We ended 2012 experiencing solid growth in fourth quarter DIFICID sales after introducing strategic initiatives to increase patient access to DIFICID and accelerate product adoption. Treatments shipped increased by over 14% from the third quarter. We believe the early response to our new strategy is very encouraging. Hospital contracting, among other efforts, appears to be having a positive impact. We are particularly encouraged by increased DIFICID use in hospitals that our sales force is targeting, and by the number of hospitals that are initiating a review of DIFICID's formulary position.
surf1944
12 years ago
8:03AM Optimer Pharma and AstraZeneca (AZN) collaborate to commercialize fidaxomicin for clostridium difficile infection in Latin America (OPTR) 10.17 : Co announced today the execution of an exclusive agreement with AstraZeneca to commercialize fidaxomicin tablets for the treatment of Clostridium difficile Infection in South America, including Brazil, Central America, Mexico and the Caribbean.
Under the terms of the agreement AZN is responsible for the commercialization of fidaxomicin in the territory covered by the collaboration and OPTR is entitled to receive an up-front payment of $1 mln, up to $3 mln in milestone payments upon first commercial sale in certain countries, and up to $19 mln in other milestone payments contingent on the achievement of sales-related targets for fidaxomicin in the territory. Co is further entitled to receive payments from AstraZeneca that provide a return resulting in a double digit percent of net sales in the territory under a fidaxomicin supply agreement.
surf1944
12 years ago
7:03AM Optimer Pharma: CMS grants new technology add-on payment to DIFICID for treatment of clostridium difficile-associated diarrhea (OPTR) 12.88 : Co announced that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment for DIFICID tablets administered in the inpatient setting to treat Clostridium difficile-associated diarrhea. The NTAP payment will provide hospitals with a payment, in addition to the standard-of-care DRG reimbursement, of up to 50% of the cost of DIFICID for a period of two to three years, effective in the fiscal year starting on October 1, 2012. For 2013, CMS has assigned a maximum payment of $868.00. The NTAP payment is available to hospitals only for individual patient cases that are more costly than the average DRG charges.
surf1944
13 years ago
7:08AM Optimer Pharma (Halted) removes Chang as Board of Directors and Prunty as CFO following compliance issue; co appoints Hank McKinnel new Board of Directors; preannounces Q1 rev below ests (OPTR) 14.29 : The Optimer Board of Directors removed Dr. Michael Chang as Chairman and terminated John D. Prunty, Chief Financial Officer, and Dr. Youe-Kong Shue, Vice President. The Board, excluding Dr. Chang, unanimously approved the personnel changes. The co said that Dr. Chang remains as a Director of the co , but that the Board has requested his resignation. Dr. Chang's removal as Chairman resulted from the Board's views as to his actions in his capacity as Optimer's representative on the Board of Directors of OBI as well as his failure to identify and effectively manage compliance, record keeping and conflict of interest issues in connection with OBI's grant to Dr. Chang, potentially for the benefit of a third party, of 1.5 million shares of OBI. The terminations of Mr. Prunty and Dr. Shue were related to the belief of Optimer's Independent Directors that both individuals failed to follow proper procedures when they became aware of the issues related to the issuance of the OBI shares to Dr. Chang. The co said it has disclosed the matter to the relevant U.S. authorities and is cooperating with those authorities in reviewing the matter. Optimer's Board has determined to remove Dr. Chang from OBI's Board of Directors and to appoint Dr. McKinnell to replace Dr. Chang as Optimer's representative on the OBI Board. Board of Directors has appointed Hank McKinnell as its new Chairman. Dr. McKinnell was previously appointed Lead Independent Director at the Feb 29, 2012 Board meeting. The Company also announced that Kurt Hartman -- who currently serves as General Counsel, Chief Compliance Officer and Senior Vice President -- has been appointed acting CFO and a search for a permanent CFO has commenced. The changes are not expected to materially impact the Company's revenues or operations.
Separately, the co announced that, based upon preliminary results, it expects to report Q1 gross revenues of ~$16.45 mln vs. the $29.4 mln consensus, an increase of ~36% over gross revenues for the fourth quarter of 2011.
surf1944
13 years ago
1:54AM Optimer Pharma presents post-hoc subgroup analysis of DIFICID in adult cancer patients being treated for clostridium difficile-associated diarrhea had higher clinical cure rates, better sustained response and lower recurrence (OPTR) 13.90 : Co announces the presentation of results from a post-hoc subgroup analysis of the co's two large Phase 3 trials which demonstrated that cancer patients with Clostridium difficile-associated diarrhea had higher clinical cure rates, better sustained response and lower recurrence when treated with DIFICID tablets compared to oral vancomycin. In the overall combined population, patients with cancer had significantly lower cure and sustained response rates than patients without cancer. DIFICID was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence. Specifically, DIFICID provided superior response compared to vancomycin across all clinical endpoints studied: clinical response (97.3% vs. 87.5%), sustained response (83.6% vs. 61.3%) and disease recurrence (14.1% vs. 30.0%). Furthermore, cancer patients who were treated with DIFICID in the clinical studies had similar cure, recurrence and sustained response rates as non-cancer patients who received the drug, while cancer patients treated with vancomycin tended to have poorer outcomes than non-cancer patients. The overall safety profile was similar between the DIFICID and vancomycin treatment groups.
surf1944
13 years ago
January 9, 2012
08:47 EDT OPTR
theflyonthewall.com: Optimer provides update on DIFICID tablets launch
Optimer Pharmaceuticals provided an update on commercial sales of DIFICID, or fidaxomicin, tablets since launching the antibacterial drug in July 2011 for the treatment of Clostridium difficile associated-diarrhea, or CDAD, in adults 18 years of age or older in the U.S. Pedro Lichtinger, President and CEO commented: "Sales of DIFICID in the U.S. over the past five and a half months reflect the strong initial demand for a new antibacterial drug providing a superior sustained clinical response through 25 days after the end of treatment for CDAD. Wholesale level shipments in Q4 of 2011 increased almost 87% compared to Q3, drawing down wholesaler inventory levels. We also observed continued strong month over month growth through the fourth quarter of about 11%." :theflyonthewall.com
surf1944
13 years ago
Optimer Pharmaceuticals and Astellas Receive Positive Opinion from CHMP for European Approval of DIFICID
Press Release Source: Optimer Pharmaceuticals, Inc. On Friday September 23, 2011, 8:00 am
SAN DIEGO, Sept. 23, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR - News) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR™ (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea (CDAD).
(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)
DIFICLIR, which is known as DIFICID™ in the United States (US), was approved by the US FDA in May 2011 for the treatment of CDAD in adults 18 years of age and older. Astellas is Optimer's exclusive licensee to develop and commercialize DIFICLIR in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States.
The CHMP positive opinion is based on Phase 3 clinical studies that were conducted to compare the safety and efficacy of 400mg/day fidaxomicin with 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in 629 subjects in North America (US and Canada). The second Phase 3 study was carried out in 535 subjects in North America and Europe. The results of the studies showed that the proportion of subjects in which clinical cure was achieved at the end of 10 days of treatment were similar for both treatments; thus fidaxomicin met its primary endpoint of non-inferiority to vancomycin. Furthermore in both trials, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin at 30 days after completion of treatment.
"A positive CHMP opinion is an important milestone for Optimer and is a key step to making fidaxomicin more widely available to patients around the globe for this serious disease," said Pedro Lichtinger, President and CEO of Optimer.
The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months of the CHMP opinion.
Important Safety Information for DIFICID
DIFICID should not be used for systemic infections
Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria
The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%)
About CDAD
Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDAD is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDAD, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDAD patients are 65 years of age or older.
surf1944
13 years ago
Avg Vol (3 month)3: 901,036
Avg Vol (10 day)3: 2,131,490
Shares Outstanding5: 46.60M
Float: 42.26M
% Held by Insiders1: 8.89%
% Held by Institutions1: 44.10%
Shares Short (as of Aug 31, 2011)3: 7.20M
Short Ratio (as of Aug 31, 2011)3: 7.90
Short % of Float (as of Aug 31, 2011)3: 19.30%
Shares Short (prior month)3: 7.07M
the shorts are helping the OPTR PPS
stocktrader001
13 years ago
3 Stocks Shaking the Market
By Rich Duprey | More Articles
September 14, 2011 | Comments (1)
Some stocks are one-hit wonders, making a big splash when they first appear, then quickly fizzling into obscurity or oblivion. But for other stocks, that initial big move is only a preview for even bigger and better gains to come.
Today, we've listed three stocks that made some of the biggest upward moves over the past month, despite the incredible volatility in the market, which we'll pair with the ratings issued by our Motley Fool CAPS community. The higher each stock's rating, the greater CAPS members' faith in that company's ability to keep on beating the market.
Stock
1-Month Change
CAPS Rating
(out of 5)
Optimer Pharmaceuticals (Nasdaq: OPTR ) 66.5% **
Eastman Kodak (NYSE: EK ) 53.3% *
Majesco Entertainment (Nasdaq: COOL ) 43.7% **
Source: FinViz.com.
While you were out, the markets collapsed and may continue to do so as concerns over Europe escalate. So before we get shaken out again, let's see why the CAPS community thinks these three companies might continue to outperform the market.
A mighty temblor
Ignore the wider losses that Optimer Pharmaceuticals reported this past quarter, since it was ramping up the launch of its diarrhea drug Dificid. The launch is going well, with sales, while small at $3.9 million, doubling analyst estimates. Approved by the FDA back in May, Dificid -- which is used to treat hospital-acquired diarrhea -- was launched in July.
The drug -- which was found to be non-inferior to ViroPharma's Vancocin in achieving its goals at the end of treatment, but superior to it by having a sustained clinical response -- will be co-promoted with Cubist Pharmaceuticals (Nasdaq: CBST ) over a two-year period. A second agreement with Astellas will have that pharmaceutical market the drug pretty much everywhere outside of the U.S. Looking to target more than 2,000 hospitals domestically, and with costs associated with the ailment estimated to be around $3.2 billion annually, there's a fairly large market to tackle.
Insiders have been buying up shares, but the CAPS community has been rather sanguine about Optimer's potential, with just 78% expecting it to outperform the market. Add your thoughts on where the drug developer will go on the Optimer Pharmaceuticals CAPS page and put it on your watchlist to keep track of its progress.
Picture this
Euphoria over the rich valuation suddenly assigned to patent portfolios sent Eastman Kodak's shares soaring. A $4.5 billion payout for a bankrupt company's IP and a $12.5 billion buyout of Motorola Mobility (NYSE: MMI ) by Google had investors sending shares of everyone from InterDigital (Nasdaq: IDCC ) to VirnetX (AMEX: VHC ) higher thinking they, too, would be able to cash in.
Kodak has thought its rather deep portfolio might be worth a pretty penny or two. It floated the idea that it was considering going to market to see what the patents might fetch, particularly the one with which they've been trying to bludgeon Apple and Research In Motion.
Although some analysts pegged Kodak's patent value at about $3 billion, that might be wishful thinking. Kodak's patents may not be worth anywhere near what the market was willing to pay for mobile communications patents, as a rising tide doesn't necessarily lift boats in a different port. Kodak's star has fallen considerably from its heyday, and even if it's able to wrangle a few dollars from its IP, the fast-fading brand likely won't attract the kind of money an up-and-coming one would.
Just 58% of the CAPS All-Stars rating Kodak think it can beat the market. Tell us in the comments section below or on the Eastman Kodak CAPS page if you see it developing any growth from here.
Cool, dude
When Microsoft surprised the market by selling boatloads of its Kinect motion-sensing systems (10 million as of March), it gave a much-needed boost to the software industry that was weakened by the recession. Yet, it has only two real breakout hit games to speak of so far, Dance Central and Kinect Sports. Both are multimillion-unit sellers, but you'd be hard-pressed to name another big one.
Similarly, game maker Majesco Entertainment has relied upon the mammoth success it enjoyed with its Zumba Fitness title, which accounts for three-quarters of all its revenues. Although it acquired free-to-play sports title developer Quick Hit to bolster its social-gaming division, it's doubling down on Zumba by coming out with a follow up release of the title. To keep growing, though, it's going to need a more robust lineup.
While the CAPS community is bullish on Majesco and CAPS member Jonock sees it doubling in value over the next three months, should such faith be placed in a company whose fortunes are tied to one title? Let us know on the Majesco Entertainment CAPS page if you think the game is rigged against it succeeding.
Shake, rattle, and roll
With these stocks shaking the market this past month it pays to start your own research on them at Motley Fool CAPS. Read a company's financial reports, scrutinize key data and charts, and examine the comments your fellow investors have made, all from a stock's CAPS page.
http://www.fool.com/investing/general/2011/09/14/3-stocks-shaking-the-market.aspx
surf1944
13 years ago
2. Optimer Pharmaceuticals, Inc. (OPTR): Focuses on discovering, developing and commercializing hospital specialty products worldwide. Market cap of $488.37M. Current ratio at 13.97, quick ratio at 13.85. Long-term debt/equity at 0. Net institutional shares purchased over the current quarter at 7.0M, which is 16.56% of the company's 42.26M share float. The stock is a short squeeze candidate, with a short float at 15.59% (equivalent to 10.1 days of average volume). The stock has had a couple of great days, gaining 20.05% over the last week.
http://seekingalpha.com/article/292273-7-highly-liquid-low-debt-biotech-stocks-seeing-smart-money-buys?source=yahoo
surf1944
14 years ago
News Breaks
June 2, 2011
08:04 EDT OPTR
theflyonthewall.com: Optimer reports inducement grants under NASDAQ listing rule 5635c4
Optimer Pharmaceuticals announced that on May 31, the Compensation Committee of its Board of Directors approved the grant of inducement stock options to purchase an aggregate of 411,750 shares of common stock to 27 new employees. Each stock option has an exercise price per share equal to $14.51, the fair market value on the grant date, and vests over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and 1/48 of the shares vesting monthly thereafter, subject to the new employee's continued service relationship with the company. Each stock option also has a ten year term and is subject to the terms and conditions of the company's 2006 Equity Incentive Plan and the stock option agreement pursuant to which the option was granted. The stock options were granted as inducements material to the new employees entering into employment with Optimer in accordance with NASDAQ Listing Rule 5635c4. :theflyonthewall.com
invest2win
14 years ago
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) should be getting shredded today, after Friday's bearish outside day reversal - that's usually a real killer for small cap stocks that trade this thinly. Yet, here we are, with OPTR not only blowing off Friday's high-volume selloff, but on track to finish the day above where it left off Thursday (totally negating Friday's implosion), and poised to do so on higher volume than we saw behind Friday's implosion. Simply put, that was the best shot the bears had at knocking OPTR down once and for all, and they just couldn't do it. Maybe it's got something to do with the fact that Optimer Pharmaceuticals is a $643 million company that now has a real and marketable drug to treat intestinal infections - a market that could be worth at least the same amount.
http://www.smallcapnetwork.com/Reading-the-Tea-Leaves-for-RUTH-OPTR-and-EEE/s/via/1789/article/view/p/mid/1/id/10/
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Penny Roger$
13 years ago
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