Endo: An Underappreciated Platform
Endo's Bid For Auxilium Makes Sense
Stephen Simpson, CFA
Stephen Simpson, CFA
Endo Health Scores A Huge Win
Stephen Simpson, CFA
Stephen Simpson, CFA
Tue, Jun. 28, 2:57 AM
- Endo International (NASDAQ:ENDP) has held discussions with P-E firms about potential asset sales to reduce its more than $8B debt pile.
- Pfizer (NYSE:PFE) is investing $350M to build its first biotech center in China.
- Horizon Pharma (NASDAQ:HZNP) has hired Bank of America to help it explore selling a significant equity stake that would bolster its balance sheet.
Fri, Jun. 17, 7:06 AM
- Hill Rom Holdings (NYSE:HRC) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $62 (20% upside) from $54.
- Arbutus Biopharma (NASDAQ:ABUS) upgraded to Neutral from Sell by Chardan. Price target is $3.25 (1% downside risk).
- Achaogen (NASDAQ:AKAO) upgraded to Outperform from Neutral by Wedbush. Price target raised to $10 (111% upside) from $7.
- PRA Health Sciences (NASDAQ:PRAH) upgraded to Overweight from Sector Weight by KeyBanc. Price target is $55 (25% upside).
- Agios Pharmaceuticals (NASDAQ:AGIO) upgraded to Buy from Hold by JPMorgan. Price target raised to $62 (30% upside) from $50.
- Quidel (NASDAQ:QDEL) upgraded to Outperform from Market Perform by Raymond James. Price target is $21.50 (20% upside).
- Aptose Biosciences (NASDAQ:APTO) upgraded to Buy from Neutral by Roth Capital. Price target raised to $8 (186% upside) from $4.
- Endologix (NASDAQ:ELGX) upgraded to Buy from Hold with a $15.50 (23% upside) price target by Canaccord Genuity.
- Endo International (NASDAQ:ENDP) upgraded to Neutral from Underperform by Mizuho Securities. Price target raised to $16 (5% downside risk) from $13.
- United Therapeutics (NASDAQ:UTHR) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $95 (11% downside risk) from $175.
- Infinity Pharmaceuticals (NASDAQ:INFI) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $1 (32% downside risk) from $11.
- LDR Holding (NASDAQ:LDRH) downgraded to Market Perform from Outperform by Cowen & Company.
- Marinus Pharmaceuticals (NASDAQ:MRNS) downgraded to Perform from Outperform by Oppenheimer. $17 price target removed. Also downgraded to Sector Perform from Outperform by RBC Capital.
- Mesoblast (NASDAQ:MESO) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $5 (21% upside) from $10.
- Revance Therapeutics (NASDAQ:RVNC) downgraded to Hold from Buy by Brean Capital. Price target removed.
- OraSure (NASDAQ:OSUR) downgraded to Market Perform from Outperform by Raymond James. Price target is $8 (15% upside).
Wed, Jun. 15, 9:58 AM
- The FDA has informed Endo International (ENDP +1.4%) unit Endo Pharmaceuticals that an Advisory Committee will meet in the fall to review and discuss its Supplemental New Drug Application (sNDA) seeing approval of an abuse-deterrent formulation of opioid pain med OPANA ER (oxymorphone HCl). The schedule means that the agency's current July 29 action date (PDUFA) will not be met. A decision should happen shortly after the meeting.
- The abuse-deterrent version of OPANA ER is based on Grunenthal's INTAC technology which uses a high molecular weight polymer (polyethylene oxide) to harden pills making them resistant to crushing.
Mon, Jun. 13, 1:17 PM
- A Phase 2 clinical trial assessing BioSpecifics Technologies' (BSTC +3.4%) collagenase clostridium histolyticum (CCH) for the treatment of human lipoma successfully achieved its primary endpoint of reducing the visible surface area of the target lipomas compared to placebo. All secondary efficacy endpoints were also met.
- Results from the 19-subject trial showed an 81.3% reduction in the visible surface area of the target lipoma in the CCH group compared to a 2.1% increase for placebo (p<0.0001) as measured by caliper six months following injection. In addition, 89.5% of CCH-treated patients were responders at month 6 versus 0% for placebo (p<0.0001).
- No drug-related serious adverse events were reported and no participant dropped out of the trial. The most common adverse events were injection site-related (swelling, pain, itching).
- CCH, administered directly into a lipoma via injection, potentially offers patients an alternative to surgery. Lipomas are benign encapsulated deposits of fat that appear as bulges under the skin. The cause is unknown but is believed to be hereditary.
- The company intends to review the data with partner Endo International (ENDP +0.1%) who has the right to opt-in for this indication. If it exercises its option, BSTC will earn a cash payment, future milestones and royalties on net sales. Also, Endo would be responsible for future development costs.
- CCH is currently marketed by Endo under the brand name XIAFLEX for the treatment Dupuytren's contracture and Peyronie's disease.
Mon, Jun. 13, 12:10 PM
- Adamas Pharmaceuticals (ADMS -1.3%) announces positive results from a Phase 2 proof-of-concept clinical trial assessing lead product candidate ADS-5102 in patients with multiple sclerosis (MS) who have trouble walking. According to the company, the data "suggests" that ADS-5102 was well-tolerated and had a significant impact on walking speed. It plans to present the results at an upcoming scientific conference.
- The 60-subject randomized, double-blind, placebo-controlled trial evaluated a daily dose of 340 mg of ADS-5102 for four weeks. The key metric was the timed 25-foot walking test (T25FW) where treated patients showed a ~15% improvement in walking speed versus placebo (p<0.05) in the modified intent-to-treat population (n=56). Other walking performance measures were directionally consistent, which means that the results favored ADS-5102 but fell short of statistical significance.
- Adverse events were consistent with the known safety profile of amantadine. The majority of participants experienced at least one adverse event (AE) with most being mild or moderate. Five patients in the ADS-5102 group discontinued treatment due to an AE, one due to a serious AE related to ADS-5102.
- CEO Greg Went says, "We are now ready to speak with the FDA about a pivotal (Phase 3) registration program for impaired walking in people with MS."
- ADS-5102 is an extended-release formulation of Parkinson's disease drug amantadine, originally approved by the FDA in November 2003 under the brand name Symmetrel, marketed by Endo Pharmaceuticals (ENDP).
Fri, Jun. 10, 7:19 AM
- Boston Scientific (NYSE:BSX) initiated with Buy rating and $26 (13% upside) price target by Guggenheim Securities.
- Zimmer Biomet Holdings (NYSE:ZBH) initiated with Neutral rating and $140 (18% upside) price target by Guggenheim Securities.
- Edwards Lifesciences (NYSE:EW) initiated with Neutral rating and $120 (18% upside) price target by Guggenheim Securities.
- Oncobiologics (Pending:ONS) initiated with Buy rating and $15 (218% upside) price target by Cantor Fitzgerald.
- Walgreens Boots Alliance (NASDAQ:WBA) reinstated with Buy rating and $95 (20% upside) price target by Bank of America.
- Goldman Sachs initiates coverage of specialty pharma with a Neutral rating: Buy: Jazz Pharma (NASDAQ:JAZZ) - $196 (26% upside) price target, Horizon Pharma (NASDAQ:HZNP) - $24 (30% upside) price target; Neutral: Endo International (NASDAQ:ENDP) - $20 (11% upside) price target, Mallinckrodt (NYSE:MNK) - $73 (17% upside) price target, Momenta Pharmaceuticals (NASDAQ:MNTA) - $14 (19% upside) price target; Concordia Healthcare (NASDAQ:CXRX) - $32 (31% upside) price target; Sell: Impax Laboratories (NASDAQ:IPXL) - $33 (2% downside risk) price target.
- Biocept (NASDAQ:BIOC) initiated with Buy rating and $1.20 (71% upside) price target by Roth Capital.
- Seres Therapeutics (NASDAQ:MCRB) initiated with Outperform rating and $40 (22% upside) price target by Cowen & Company.
- Omeros (NASDAQ:OMER) initiated with Buy rating and $21 (94% upside) price target by Cantor Fitzgerald.
- Glaukos (NYSE:GKOS) initiated with Buy rating and $35 (30% upside) price target by Cantor Fitzgerald.
- Shire plc (NASDAQ:SHPG) initiated with Overweight rating and GBX5,600 (34% upside) price target by Morgan Stanley.
Wed, May 11, 4:51 AM
- The U.S. Attorney's Office for the Southern District of New York is investigating contracts between drugmakers and pharmacy benefit managers.
- Federal prosecutors have approached at least three companies, including Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK) and Endo International (NASDAQ:ENDP).
- When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.
Fri, May 6, 12:45 PM
Fri, May 6, 9:11 AM
Fri, May 6, 8:51 AM
- Endo International (NASDAQ:ENDP) slumps 33% premarket on robust volume in response to its lowered 2016 guidance provided after the close yesterday. The company beat Q1 consensus on earnings and sales but revised its non-GAAP EPS outlook for the year to $4.50 - 4.80 on revenues of $3.87B - 4.03B, down from $5.85 - 6.20 on revenues of $4.32B - 4.52B.
- Non-GAAP EPS for Q1 was down almost 8% yoy, while GAAP net income dropped 159%.
Thu, May 5, 5:35 PM
Thu, May 5, 4:18 PM
Wed, May 4, 5:35 PM
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Mon, Apr. 25, 12:47 PM
Thu, Mar. 31, 10:10 AM
- The U.S. Federal Trade Commission (FTC) has filed a complaint in federal court accusing Endo International (ENDP -4.3%) unit Endo Pharmaceuticals and several other drug firms of using pay-for-delay deals to block the market launch of lower-cost generic versions of pain med Opana ER (oxymorphone HCl) and shingles pain patch Lidoderm (lidocaine patch 5%).
- The FTC's suit alleges Endo paid the first filers, Impax Laboratories (IPXL -1%) and Watson Laboratories (AGN -0.2%), to delay the launches of their versions of the two products. The complaint seeks a court judgement declaring that the defendants' conduct violated antitrust laws, the disgorgement of their ill-gotten gains and a permanent injunction barring them from future anti-competitive behavior.
- In 2010, Endo alleged paid Impax more than $112M to delay the launch of its generic version of Opana ER until January 2013. Opana ER sales in 2012 were more than $250M. In May 2012, Endo and its partners Teikoku Seiyaku Co. Ltd. and Teikoku Pharma USA allegedly paid Watson hundreds of millions of dollars, including $96M of free Lidoderm product, to delay the launch of its generic version of Lidoderm, a $1B business at that time, until September 2013. For the first 7 1/2 months after September 2013, Endo made a deal with Watson not to market its own generic version which enabled Watson to be the only generic supplier on the market.
- The charges against the Japanese firms has been settled via a stipulated order for permanent injunction that prohibits the Teikoku entities from engaging in certain types of reverse-payment agreements for 20 years.
Mon, Mar. 21, 12:32 PM
- Endo International (ENDP -3.1%) eases on increased volume in response to the news that the FDA has approved a generic version of Voltaren Gel (diclofenac sodium topical gel) 1%, a topical non-steroidal anti-inflammatory medication for the treatment of arthritis pain, a product that accounted for more than 6% of company's 2015 sales ($207.2M/3268.7M).
- The company says its 2016 guidance issued last month anticipated that the appearance of a generic competitor would not materially impact Voltaren Gel sales until the end of the year. Should the market launch commence soon, management will update its guidance no later than its Q1 earning presentation in early May. It has the option of launching its own generic under its December 2015 license agreement with Novartis (NVS +1.1%) and its Sandoz unit.
- Endo also says it has no plans to reduce its pain salesforce as it is in the midst of launching BELBUCA (buprenorphine HCl buccal film), cleared by the FDA in October 2015.
Endo International Plc operates as a pharmaceutical company. It focuses on developing, manufacturing, and distributing of branded and generic pharmaceutical products. The company was founded on October 31, 2013 and is headquartered Dublin, Ireland.
Industry: Drug Manufacturers - Other
Country: United States
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