Osiris Therapeutics Beset By Newer And Bigger Troubles
Richard Pearson • 17 Comments
Richard Pearson • 17 Comments
Osiris: Aggressive Channel Stuffing, Accounting Irregularities Or Outright Fraud?
Richard Pearson • 55 Comments
Richard Pearson • 55 Comments
Fri, Jun. 10, 4:10 PM| Fri, Jun. 10, 4:10 PM | 2 Comments
Fri, Jun. 3, 11:00 AM
- The trading halt in Mesoblast (NASDAQ:MESO) ADSs, instituted June 1, will remain in effect until June 10, at the company's request. Based on experience, this type of scenario almost always portends negative news.
- Analysts speculate that Teva Pharmaceutical Industries (TEVA -2.3%) could pull out of its collaboration with the company since it lies outside of its core business or the news could relate to an accounting issue, FDA warning or safety matter. In a tweet, TheStreet's Adam Feuerstein speculated that the news could be related to a criminal probe of Osiris Therapeutics (OSIR -1.9%), whose culture-expanded mesenchymal stem cell business Mesoblast acquired in 2013.
- Investors began heading for the exits more than two months before June 1. Shares had slumped 35% from the high of $10.89 on March 17 when halted.
Tue, May 31, 12:50 PM
Tue, May 31, 11:00 AM
Tue, May 31, 10:44 AM
- Thinly traded micro cap Osiris Therapeutics (OSIR -14.8%) is down on higher-than-normal volume in response to a regulatory filing in which the company discloses that it is the target of a criminal investigation by the U.S. Attorney's Office for the Southern District of New York concerning matters currently being investigated by the SEC.
Tue, May 3, 12:12 PM
- In a statement issued today, MiMedx Group (MDXG -2.3%) takes issue with a press release issued yesterday by Osiris Therapeutics (OSIR -3.3%) touting "results" from a retrospective analysis of medical records at a 70-bed Montana hospital that showed Osiris' Grafix placental membrane allograft was more effective in healing wounds than MiMedx's EpiFix, an amniotic membrane allograft.
- According to Osiris, the analysis was based on 79 patients with 101 acute/chronic wounds who received at least one application of either Grafix or EpiFix between February 2014 and March 2016 at the Bozeman Health Deaconess Hospital, Wound and Hyperbaric Center. 39 patients with 55 wounds received EpiFix and 40 patients with 46 wounds received Grafix.
- The analysis showed a 63.0% complete wound closure rate (n=29/46) in the Grafix group compared to 18.2% (n=10/55) for EpiFix. A p value <0.0001 was provided to lend credibility to the difference, but it is meaningless considering the retrospective non-random nature of the data. 90% of the wounds in both groups achieved closure by week 12. Several other metrics were cited that showed Grafix was more effective than EpiFix.
- MiMedx cites a laundry list of problems with the analysis, including the lack of matching comparable wounds and treatments, the failure to take into account comorbidities, infections, wound type and age, an ill-defined treatment period of 12 weeks, the lack of information re the number of allograft applications and the absence of information about patients who discontinued treatment or were lost to follow-up. In addition, the company's sales of EpiFix to the medical center failed to correlate with expected volumes based on appropriate treatment of 55 patients during the review period.
- Wound care products accounted for ~74% of MiMedx's Q1 revenue of $53.4M.
Tue, Mar. 22, 7:59 PM
- Osiris Therapeutics (NASDAQ:OSIR) receives a deficiency letter from Nasdaq prompted by its failure to file its 2015 10-K on time. It has until May 16 to submit a plan to regain compliance. Last week, it announced that it would be unable to file its annual report on time due to accounting errors related to certain distributor contracts.
- Previously: Osiris unable to file 2015 annual report due to accounting errors; shares down 26% premarket (March 16)
Wed, Mar. 16, 9:21 AM
- Thinly traded micro cap Osiris Therapeutics (NASDAQ:OSIR) is off 26% premarket on average volume in response to a regulatory filing disclosing that it will be unable to file its 2015 10-K on a timely basis. The delay is due to accounting errors found by the Audit Committee related to revenue recognition under certain distributor contracts. The company has determined that its 2014 10-K and its reports for the three- and nine-month periods ending September 30, 2015 can no longer be relied upon.
- The corrected statements will be filed as soon as possible.
Fri, Feb. 5, 7:29 AM
- BioSpace's Mark Terry reports that the resignation of Osiris Therapeutics' (NASDAQ:OSIR) CEO Lode Debrabandere on Wednesday is yet another red flag permeating the troubled company's operations. The company's auditor, BDO USA, backed out in December. Never a good sign.
- SA Contributor Richard Pearson published his take on the situation in mid-January. Among a list of questionable practices, he says the company is engaging in "buy and hold" whereby it is booking sales but holding product on site rather than shipping it customers. This is a major no-no. No legitimate accounting firm would support this activity.
- Shares have lost ~80% of their value since last summer. Somethin' ain't right.
- Previously: Osiris chief bids adieu (Feb. 3)
- Previously: Osiris down 12.8% after disclosing auditor's resignation (Dec. 17, 2015)
Wed, Feb. 3, 4:42 PM
- Osiris Therapeutics (NASDAQ:OSIR) President & CEO Lode Debrabandere, Ph.D., resigns for personal reasons. Chief Business Officer Dwayne Montgomery is appointed interim CEO and VP and General Manager of Wound Care Frank Czworka is promoted to Chief Operating Officer.
- A search for a permanent CEO is underway.
Dec. 17, 2015, 6:25 PM
- Osiris Pharma (NASDAQ:OSIR) discloses BDO USA is resigning as its independent registered public accounting firm.
- While BDO's reports on Osiris' 2013 and 2014 financial statements didn't contain "any adverse opinion or disclaimer of opinion," the firm "advised that their opinion on the effectiveness of the Company's internal controls over financial reporting as of December 31, 2014 should no longer be relied upon due to management's identification of a material weakness in internal controls over financial reporting related to the timing of revenue recognition under certain distribution contracts."
- In addition, while prepping Osiris' Q3 10-Q, BDO and Osiris "had a disagreement about the timing of revenue recognition under certain distributor contracts and about the Company's related internal controls over financial reporting." BDO recommended Osiris change its account for a Q4 2014 distributor contract, and reassess its internal controls over financial reporting to determine if a material weakness related to revenue recognition existed.
- As previously disclosed, Osiris plans to restate its Q1 and Q2 results, and amend its 2014 annual report. Ernst & Young is being hired to replace BDO.
- Shares have fallen to $9.50 after hours.
Dec. 17, 2015, 5:39 PM
Nov. 20, 2015, 1:22 PM
- Sucampo Pharmaceuticals (SCMP -0.3%) initiated with Hold rating and $19 (10% upside) price target by Jefferies.
- BioMarin Pharmaceutical (BMRN -4.8%) initiated with Buy rating and $158 (61% upside) price target; bluebird bio (BLUE +1.2%) with a Buy rating and $165 (104% upside) price target; Incyte (INCY -3.2%) with a Buy rating and $135 (20% upside) price target; Kite Pharma (KITE -0.2%) with a Buy rating and $111 (32% upside) price target and Seattle Genetics (SGEN +0.1%) with a Sell rating and $33 (25% downside risk) price target by Goldman Sachs.
- Mylan (MYL +0.4%) initiated with Overweight rating and $62 (21% upside) price target by Morgan Stanley.
- Athenahealth (ATHN +0.4%) initiated with Overweight rating and $170 (7% upside) price target and Allscripts Healthcare Solutions (MDRX +0.5%) with an Overweight rating and $17 (14% upside) price target by J.P. Morgan.
- Genomic Health (GHDX -0.7%) upgraded to Outperform from Market Perform by Cowen & Co. Price target raised to $35 (21% upside) from $27.
- Shire plc (SHPG -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $239 (12% upside) from $220.
- Cempra (CEMP -0.5%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $38 (30% upside) from $25.
- Athenahealth (ATHN +0.4%) downgraded to Underweight from Equal Weight by Barclays. Price target lowered to $110 (31% downside risk) from $140.
- Osiris Therapeutics (OSIR +1.9%) downgraded to Sell from Hold by Brean Capital. Price target is $8 (25% downside risk).
- Endo International (ENDP -0.3%) downgraded to Neutral from Buy by Mizuho. Price target lowered to $55 from $82 (7% downside risk).
- Kite Pharma (KITE -0.2%) downgraded to Hold from Buy by Standpoint Research. Price target maintained at $100 (19% upside).
Nov. 17, 2015, 12:47 PM
Nov. 17, 2015, 9:26 AM
Nov. 17, 2015, 9:16 AM
Osiris Therapeutics, Inc. engages in stem cell research and development of pharmaceutical products. Its regenerative medicine targets dermal burns, pressure ulcers, venous leg, diabetic foot ulcers, and tissue and bone repair. The company was founded by Peter A. Friedli and James S. Burns on... More
Country: United States