Fri, Aug. 14, 3:45 PM
- The U.S. District Court for the Southern District of New York rules that Actavis, the U.S. generics business of Allergan (AGN -0.4%), infringed on two Endo International (ENDP +2%) patents with its generic version of Endo's OPANA ER (oxymorphone HCl), an opioid agonist for the treatment of pain severe enough to require daily, around-the-clock treatment with an opioid.
- As a result of the ruling, Allergan's generic product will be removed from the market and planned launches from other generic drug makers will be delayed indefinitely.
- Endo filed suit against Actavis in December 2012.
Mon, Aug. 10, 8:38 AM
- Endo (ENDP +2.5%) Q2 results: Revenues: $735.2M (+24.0%); COGS: $438.9M (+44.7%); R&D Expense: $19M (-37.5%); SG&A: $154.5M (+24.2%); Operating Income: $1.5M (-98.6%); Net Loss: ($90.9M) (-323.9%); Loss Per Share: ($0.49) (-296.0%); Quick Assets: $2.5M (+525.0%).
- 2015 Guidance: Total revenue: $2.90B - 3.00B (unch); GAAP EPS: $1.42 - 1.62 from $1.70 - 1.90; non-GAAP EPS: $4.40 - 4.60 (unch).
Mon, Aug. 10, 6:32 AM
Sun, Aug. 9, 5:30 PM
Tue, Jul. 21, 12:03 PM
- Thinly traded micro cap BioSpecifics Technologies (BSTC +1.7%) is up again today. Shares were up over 20% since yesterday morning when the company announced that the Japanese Pharmaceutical and Medical Device Agency approved XIAFLEX (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture (DC).
- Asahi Kasei Pharma has the rights to develop and market XIAFLEX in Japan via an agreement with Biospecifics partner Endo International (NASDAQ:ENDP). BSTC will receive a milestone payment when the product launches.
- DC is caused by an abnormal accumulation of collagen in the palm of the hand. The thickening of the fibrous tissue underneath the skin causes the fingers to curl. The precise cause is unknown but hereditary factors appear to play a role.
- XIAFLEX was approved in the U.S. for the treatment of DC in February 2010 and Peyronie's disease in December 2013. The European Commission approved it for DC in February 2011 and Peyronie's in February 2015.
Fri, Jun. 19, 9:54 AM
Fri, Jun. 5, 4:19 PM
Mon, May 18, 10:05 AM
- Endo International (ENDP -2.2%) acquires privately-held generic drug maker Par Pharmaceuticals from private equity firm TPG for $8B. The cash-and-stock deal consists of 18M ENDP shares and $6.5B in cash, including the assumption of debt.
- Par markets a portfolio of almost 100 products. The generics business of the combined companies will rank in the top five in terms of U.S. sales.
Mon, May 11, 9:43 AM
- Endo (ENDP -1.2%) Q1 results: Revenues: $714.1M (+51.7%); COGS: $384.3M (+80.7%); R&D Expense: $17.9M (-42.1%); SG&A: $211.6M (+32.2%); Operating Income: $45.7M (+108.7%); Net Income: $150.5M (+417.5%); EPS: $0.85 (+329.7%); Quick Assets: $377.5M (-7.7%).
- 2015 Guidance: Total revenue: $2.90B - 3.00B; GAAP EPS: $1.70 - 1.90 from $2.73 - 2.93; non-GAAP EPS: $4.40 - 4.60 from $4.35 - 4.55.
Mon, May 11, 9:01 AM
- Endo International (NASDAQ:ENDP) acquires a broad portfolio of branded and generic injectable and established drugs from a subsidiary of Aspen Holdings, a publicly traded firm in South Africa, for $130M. The products include pain and cardiovascular medications, anti-infectives and other specialty therapeutic areas.
- The products generated ~$28M in top-line sales in South Africa for the 12-month period ending June 30, 2014. The transaction also includes a pipeline of candidates that should launch in the next few years.
- Endo will fold the business into its Litha Healthcare Group. It is expected to increase Litha's pro-forma 2015 revenues by 30%.
- The deal should close in Q3.
Mon, May 11, 7:02 AM
Sun, May 10, 5:30 PM
Fri, Apr. 24, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Fri, Mar. 27, 4:16 PM
- Brean Capital's Difei Yang says small cap Hyperion Therapeutics (NASDAQ:HPTX) should be on the acquisition radar considering Big Pharma's appetite for rare disease players. The company's revenues are generated by two products, Ravicti (glycerol phenylbutyrate) and Buphenyl (sodium phenylbutyrate), that treat urea cycle disorders, inherited metabolic diseases caused by a deficiency in one of the enzymes or transporters in the urea cycle. Elevated ammonia, a consequence of the failure to convert ammonia to urea, can have serious consequences, such as brain damage, coma and even death.
- Mr. Yang estimates that the company's takeout price at $60 per share. He lists Shire plc (NASDAQ:SHPG), Valeant Pharmaceuticals (NYSE:VRX), and Endo International (NASDAQ:ENDP) as potential suitors. HPTX closed today at just under $43.
- The company booked ~$114M in revenues last year but took a loss of ($6.3M).
Mon, Mar. 16, 8:12 AM
- In response to Endo's (NASDAQ:ENDP) cash-and-stock bid of $175 for Salix Pharmaceuticals (NASDAQ:SLXP), Valeant Pharmaceuticals (NYSE:VRX) ups it all-cash bid to $173, representing an enterprise value of $15.8B. Valeant expects the transaction to close on April 1, contingent on the satisfaction of the minimum tender condition.
- As a result of the sweetened offer, the termination fee increases $100M to $456M.
- Previously: Endo makes a move for Salix Pharma (March 11)
Mon, Mar. 16, 1:47 AM
- Endo International (NASDAQ:ENDP), which is in a bidding war with Valeant Pharmaceuticals (NYSE:VRX) for Salix Pharmaceuticals (NASDAQ:SLXP), believes it could close a takeover within as little as five weeks of a negotiated deal, Reuters reports.
- The timing is possible because under Irish law, there is only a minimum of 17 days required between mailing proxy materials and holding a shareholder meeting. The $11.2B proposal is also not subject to financing conditions.
- Previously: Endo makes a move for Salix Pharma (Mar. 11 2015)
- Previously: Endo would have to eat breakup fee to get Salix (Mar. 11 2015)
- Previously: Valeant bond sale continues despite Endo bid (Mar. 12 2015)
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