Valeant Pharmaceuticals International, Inc. (VRX) - NYSE
  • Fri, Jul. 22, 7:10 AM
    • Valeant Pharmaceuticals' (NYSE:VRX) Bausch + Lomb unit receives a Complete Response Letter (CRL) regarding its New Drug Application (NDA) seeking approval of latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
    • The CRL cited deficiencies observed during a Current Good Manufacturing Practice (CGMP) inspection at B+L's manufacturing site in Tampa, FL. The letter did not identify any safety or efficacy issues with the product.
    • Valeant intends to meet with the agency as soon as possible to address the matter.
    • VRX is down 2% premarket on light volume.
    | Fri, Jul. 22, 7:10 AM | 159 Comments
  • Tue, Jul. 19, 6:30 PM
    • RELISTOR (methylnaltrexone bromide) developer Progenics Pharmaceuticals (NASDAQ:PGNX) is up 7% after hours on increased volume in response to the news that the FDA has approved an oral formulation of the medicine that is indicated for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.
    • The FDA approved the injectable formulation in April 2008.
    • Exclusive licensee Valeant Pharmaceuticals (NYSE:VRX) is up 3% after hours on robust volume, mainly from the positive Ad Comm vote for brodalumab.
    • Read now Progenics: Key FDA Decision Could Power This Under $5 Biopharma Stock 
    | Tue, Jul. 19, 6:30 PM | 55 Comments
  • Wed, Jul. 6, 12:31 PM
    • Valeant Pharmaceuticals (VRX +9.6%) jumps on average volume in apparent response to comments from Walgreens Boots Alliance (WBA -2.5%) that it is "satisfied" with its relationship with the embattled drug maker. Looks like the shorts are scrambling to cover.
    | Wed, Jul. 6, 12:31 PM | 70 Comments
  • Thu, Jun. 9, 3:43 PM
    • Valeant Pharmaceuticals (VRX +5.2%) jumps on increased volume in response to the news that it is considering selling Egyptian drug maker Amoun Pharmaceutical in order to speed up its debt reduction. Goldman Sachs is advising.
    • Valeant acquired Amoun in July 2015 for ~$800M.
    • Previously: Valeant buys Amoun Pharma for $800M (July 17, 2015)
    | Thu, Jun. 9, 3:43 PM | 59 Comments
  • Tue, Jun. 7, 12:50 PM
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  • Tue, Jun. 7, 11:00 AM
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  • Tue, Jun. 7, 9:29 AM
    • Embattled Valeant Pharmaceuticals (NYSE:VRX) hosted its Q1 earnings call this morning. New chief Joseph Papa and other executives discussed their plans to stabilize the business, pay down debt and ramp growth.
    • Q1 revenues were up 9.3% yoy but GAAP EPS dropped to a loss of $1.08 from a gain of $0.28. Cash flow from operations was $558M, up 13.6%. Non-GAAP EPS was $1.27, down 38.0% from Q1 2015's $2.05.
    • The biggest bogies are dermatology, accounting for $410M (37.3%) of the $1.1B downward revision in revenue guidance and liver drug Xifaxan (rifaximin), accounting for $390M (35.5%). The Walgreens deal is the main drag on dermatology sales. According to Mr. Papa, many prescriptions are currently being filled at a loss for Valeant.
    • The company says its will be in compliance with its debt covenants this year. It has $1.2B in cash at present and expects to generate $1.73B in free cash flow in 2016. It has $273M in mandatory debt payments for the remainder of the year. Its goal is to pay down $1.7B in debt by the end of December and have no more than a 6x leverage ratio.
    • Mr. Papa's plan to stabilize the business includes re-recruiting Valeant employees, adding new talent and buffing up its relationships with patients, prescribers, payors and investors. He is confident that he can fix the dermatology business and ramp Salix and Xifaxan sales growth. Over 20 new product launches are expected this year.
    | Tue, Jun. 7, 9:29 AM | 17 Comments
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  • Fri, May 27, 11:00 AM
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  • Thu, May 26, 7:19 PM
    • Valeant Pharmaceuticals (NYSE:VRX) is up 7.1% after hours, following a report from The Wall Street Journal that Takeda (OTCPK:TKPYY) and private-equity firm TPG made a combined takeover approach in recent weeks that the company rejected.
    • No talks are ongoing between the three, though.
    • The approach came before Valeant hired Joseph Papa as its new CEO and didn't get to a firm price.
    • Updated 7:28 p.m.: The board wants to give Papa time to chart a course for the company, sources told the WSJ.
    | Thu, May 26, 7:19 PM | 133 Comments
  • Fri, May 20, 6:58 AM
    • Acorda Therapeutics (NASDAQ:ACOR) pulls the plug on developing PLUMIAZ (diazepam) Nasal Spray for the treatment of seizure clusters in patients with epilepsy. Its decision was based on ongoing clinical studies that failed to demonstrate the product candidate's bioequivalence to Valeant Pharmaceuticals' (NYSE:VRX) Diastat AcuDial (diazepam rectal gel), a requirement for the refiling of the New Drug Application (NDA). The specific issue was lower-than-expected mucosal absorption of diazepam in epileptics compared to studies in healthy volunteers.
    • The company is in communication with investigators to discontinue all clinical trials and will assist in the transition of study participants. The data will be presented as a future medical conference.
    • Acorda originally submitted its NDA in 2013 but received a Complete Response Letter (CRL) in May 2014 citing the need for three more clinical trials. Its plan was to refile the NDA in Q1 2017.
    • Shares are down 3% premarket on average volume.
    • Previously: Acorda Therapeutics projects Plumiaz NDA filing in early 2017 (May 27, 2015)
    | Fri, May 20, 6:58 AM | 4 Comments
  • Thu, May 19, 9:40 PM
    • Valeant Pharmaceuticals (NYSE:VRX) receives a notice of default from the trustee under one of its senior note indentures triggered by the delay in filing its 10-Q for the quarter ended March 31, 2016. The notice, which does not precipitate an acceleration in any of the company's debt, stipulates a 60-day window from the receipt of the notice to file the 10-Q to cure the default. Valeant intends to file the document no later than June 10, well within the July 18 cure date.
    • Shares are down 2% after hours on increased volume.
    | Thu, May 19, 9:40 PM | 46 Comments
  • Tue, May 17, 5:06 PM
    • Under new leadership, Valeant (VRX +7.5%) is looking at selling some dermatology and cancer drugs it acquired in recent years, in a move to cut debt, Bloomberg reports.
    • It's looking at selling Provenge, its treatment for advanced prostate cancer, and Obagi Medical Products, the dermatology company. Also on the block might be products it acquired from Marathon Pharmaceuticals last year (and then jacked up prices on), including Isuprel and Nitropress, sources said.
    • That could raise up to $1B as the company faces more than $30B in debt.
    • Valeant had acquired Provenge from bankrupt Dendreon early last year, and purchased Obagi in 2013.
    • New CEO Joe Papa joined Valeant earlier this month. The drugmaker's shares are down 71.4% YTD.
    • Now read Andrew Left Is Long And Valeant Could Triple From Here »
    | Tue, May 17, 5:06 PM | 80 Comments
  • Fri, May 13, 5:52 PM
    • David Tepper and Appaloosa have filed their 13F, and while it shows new positions in Valeant (NYSE:VRX), Bank of America (NYSE:BAC), Facebook (NASDAQ:FB) and Fox (FOX, FOXA), a source told CNBC that he's already sold that Valeant stake.
    • Shares in Valeant moved accordingly after the release: First up as much as 2.9% after hours, then back again to a 0.6% gain.
    • Meanwhile, the firm notes dissolved stakes in Apple (AAPL, sold 1.26M shares), HP Enterprise (HPE, sold 3.66M shares) and Eastman Chemical (EMN, sold 700K shares).
    • In energy bets, Tepper heavily increased stakes in Williams Partners (WPZ, +10.87M shares) and Energy Transfer Partners (ETP, +11M shares), while cutting a stake in Kinder Morgan (NYSE:KMI) by 4.95M shares.
    | Fri, May 13, 5:52 PM | 85 Comments
  • Mon, May 9, 8:37 AM
    • Valeant Pharmaceuticals (NYSE:VRX) intends to file its 10-Q for the quarter ending March 31 no later than June 10. Management reiterates its Q1 guidance of $2.3B - 2.4B in revenues and non-GAAP EPS of $1.30 - 1.55.
    • Shares are up 5% premarket on robust volume.
    | Mon, May 9, 8:37 AM | 48 Comments
Company Description
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology, and branded generics. The company operates through two... More
Sector: Healthcare
Industry: Drug Delivery & Accessories
Country: Canada