Today, 8:28 AM
- Endo International (ENDP +0.4%) Q4 results: Revenues: $800M (+36.8%); COGS: $423.7M (+66.9%); R&D Expense: $40.4M (+20.2%); SG&A: $192.3M (+3.2%); Operating Loss: ($72.7M) (+90.1%); Net Loss: ($53.5M) (+93.1%); Loss Per Share: ($0.35) (+94.8%).
- FY2014 results: Revenues: $2,877.2M (+9.9%); COGS: $1,400.6M (+34.7%); R&D Expense: $154.2M (+8.2%); SG&A: $795.9M (-6.3%); Operating Loss: ($896.9M) (-110.7%); Net Loss: ($721.3M) (-5.3%); Loss Per Share: ($4.91) (+18.8%); Quick Assets: $409.6M (-22.2%); CF Ops: $337.8M (+13.2%).
- 2015 Guidance: Total revenue: $2.90B - 3.00B; GAAP EPS: $2.73 - 2.93; non-GAAP EPS: $4.35 - 4.55.
Today, 7:06 AM
Yesterday, 5:30 PM
Mon, Feb. 23, 1:00 PM
- The FDA's acceptance of the New Drug Application (NDA) for Belbuca (buprenorphine HCl) buccal film for the management of pain severe enough to require daily, around-the-clock long-term opioid treatment triggers a $10M milestone payment from licensee Endo International (ENDP -0.8%) subsidiary Endo Pharmaceuticals to BioDelivery Sciences (BDSI +1.9%). The PDUFA date will be in October.
- BDSI will be eligible for an additional milestone of up to $50M upon the approval of the NDA.
- Previously: Endo and BioDelivery Sciences submit NDA for transmucosal pain med (Dec. 25, 2014)
Sun, Feb. 22, 6:53 AM
- Valeant Pharmaceuticals (NYSE:VRX) has agreed to buy Salix Pharmaceuticals (NASDAQ:SLXP) for about $10.1B, or $158 per share in cash, Bloomberg reports.
- Two other drugmakers were rumored to be on the hunt for Salix prior to the newly reported deal, including Endo International (NASDAQ:ENDP) and Shire (NASDAQ:SHPG).
- On Friday, Salix shares rose $7.11 to $157.85, almost completely eliminating any premium in the purchase price.
- Separately, Valeant received approval to buy the assets of bankrupt Dendreon (OTCPK:DNDNQ) for $495M. Dendreon is best known for its prostate cancer vaccine, Provenge.
Mon, Feb. 16, 5:50 PM
- A person close to the matter says Endo International (NASDAQ:ENDP) is and has been interested in acquiring Salix Pharmaceuticals (NASDAQ:SLXP). It has apparently sent Salix several letters stating its interest in a transaction, but Salix has yet to respond.
- Valeant Pharmaceuticals (NYSE:VRX) and Shire (NASDAQ:SHPG) are also rumored to be in hunt for the maker of products that treat gastrointestinal disorders.
- Previously: Valeant close to a bid for Salix (Feb. 12)
- Previously: Shire now on the hunt for Salix (Feb. 13)
Thu, Feb. 12, 5:33 PM
- Impax Laboratories (NASDAQ:IPXL) receives three Civil Investigative Demands (CIDs) from the Office of the Attorney General of the State of Alaska concerning its investigation into whether the company violated Alaskan state law by entering into settlement agreements with the respective brand name maker to delay the entry of generic versions of the products Adderall XR (NASDAQ:SHPG), Effexor XR (NYSE:PFE) and Opana ER (NASDAQ:ENDP).
- Such transactions are called "pay-to-delay" deals because the generic firm accepts a cash payment in exchange to delay the commercial launch of a lower-priced generic version to the branded product. This enables the branded manufacturer to maintain higher prices for an extended period.
- A CID is beefed-up subpoena which can require the recipient to produce documents, answer interrogatories or give testimony under oath.
- Impax plans to cooperate fully with the Alaska AG.
Thu, Jan. 29, 5:10 PM
Wed, Jan. 21, 7:40 PM
- Endo International (NASDAQ:ENDP) +2.9% AH on news it will join the S&P 500 later this month, replacing Covidien (NYSE:COV) after its acquisition by Medtronic (NYSE:MDT), which is expected to close next week.
- Also, Boston Beer (NYSE:SAM) will take ENDP’s spot on the S&P MidCap 400, and Southside Bancshares (NASDAQ:SBSI) is tapped to join the S&P SmallCap 600.
Wed, Jan. 21, 9:03 AM
Tue, Jan. 20, 9:25 AM| Comment!
Dec. 25, 2014, 12:41 PM
- Endo International plc (NASDAQ:ENDP) subsidiary Endo Pharmaceuticals and BioDelivery Sciences (NASDAQ:BDSI) submit a New Drug Application (NDA) to the FDA for Buprenorphine HCl Buccal Film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- The product uses BioDelivery's BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek) via a thin film that adheres to the cheek lining in less than five seconds and then completely dissolves.
- Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist which is different than full mu-opioid agonists like morphine. It is a Schedule III controlled substance which has a lower abuse potential than Schedule II drugs.
- Opioid-related tickers: (NASDAQ:ZGNX) (NYSE:PFE) (NASDAQ:EGLT) (NASDAQ:ACUR) (NYSE:MNK) (NYSE:ABBV) (NYSE:TEVA) (NASDAQ:ALKS)
Dec. 12, 2014, 7:19 AM
Nov. 24, 2014, 10:23 AM
- Endo International (ENDP +2.1%) secures the exclusive rights to Trimel BioPharma's Natesto (testosterone nasal gel) for the U.S. and Mexico. Under the terms of the agreement, Endo will pay Trimel $25M upfront plus additional regulatory- and sales-based milestones. Trimel will be responsible to manufacturing and supply and Endo will pay a tiered price based on volume.
- Natesto is an androgen indicated for replacement therapy in males with hypogonadism. It the first and only nasal gel for this indication. The FDA approved it in May 2014.
Nov. 19, 2014, 11:55 AM
- The U.S. Federal Trade Commission terminates the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for Endo International's (ENDP -0.8%) intended acquisition of Auxilium Pharmaceuticals (AUXL +0.6%).
- As previously announced, Endo will acquire all of the outstanding shares of Auxilium for $33.25 in a cash-and-stock deal valued at $2.6B. The transaction should close in Q1 2015.
- Previously: Auxilium agrees to sale to Endo for $2.6B
Nov. 7, 2014, 7:34 AM
- The FDA clears Dr. Reddy's Laboratories (NYSE:RDY) to make a generic version of Roche's antiviral Valcyte (valganciclovir). The approval follows the agency's withdrawal of tentative approval and six-month exclusivity from competitor Ranbaxy Ltd.
- The agency also granted the same approval to Endo International Plc (NASDAQ:ENDP).
- Valcyte generated ~$370M in U.S. sales in 2013.
- Previously: FDA reverses Ranbaxy tentative approvals
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