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Valeant (VRX)

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  1. [verwijderd] 14 juli 2016 20:16

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    Billionaire hedge fund manager and Valeant board member Bill Ackman was a guest on CNBC Thursday to discuss various issues, including his outlook on Valeant.

    "The underlying franchises here are strong," Ackman said in the interview. "There has clearly been business disruption as a result of recent events, but I think we got a really strong CEO."

    Ackman added that under the new CEO, Joseph Papa, Valeant is now generating cash "every single day." He added that the cash flow will be allocated towards de-levering the business and there will be no need to sell core assets.

    Ackman also stated that investing in Valeant "isn't without risk" but Papa is already "doing a very good job" and will "have a lot more to report" in a few weeks will help make investors "comfortable."

    En da's precies wat we willen, d'r warmpjes bij zitten. Welke miljairdair zullen we geloven, de shorter of longer? ;)

    Read more: www.benzinga.com/media/cnbc/16/07/821...
  2. [verwijderd] 15 juli 2016 14:29

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    Valeant Pharmaceuticals International Inc.’s stock chart has been flashing some bullish signals, defying the recent bearish actions of some prominent investors and former chief executive.

    "..............the stock’s relative strength index, a momentum indicator which compares the magnitude of recent gains with the magnitude of recent losses, has been trending higher since it bottomed at 20.83 on March 18, according to FactSet. On June 27, the RSI was up to 18.73.

    Meanwhile, Valeant’s rate-of-change indicator, which measures the pace of changes in price over a specific time period, rose from an all-time low of -61.91 on March 31 to -26.49 on June 27.

    Chart watchers refer to that type of mixed message as a bullish technical divergence. In other words, while prices continue to decline, the change in the pace or intensity of the selling suggests momentum was starting to swing the other way. And as any sports fan can attest, a sudden swing in momentum can overwhelm talent at any given moment.

    Technical divergences aren’t necessarily good market-timing tools, as they can last for months before bearing fruit. But they should be viewed as warnings against piling into a move that has taken prices to extreme levels....."

    www.marketwatch.com/story/valeants-st...
  3. [verwijderd] 15 juli 2016 16:53

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    Valeant Sure Picks the Winners
    By Derek LoweJuly 15, 2016
    You may remember brodulamab, the anti-IL-17 antibody that was under development by Amgen and AstraZeneca for psoriasis (among other indications). But it was abandoned last year when the clinical trials showed “suicidal ideation” turning up. But those canny market-driven Valeant folks picked it up for a mere $100 million, in full knowledge that this was going to be a tough one.

    And a tough one it is. The FDA advisory committee briefing documents on it are out today, and things are not going well, if these are any indication (and they often are). It turns out that there were four suicides during the psoriasis phase III trials, and two others in other trials (which I don’t think had been known until now). Additionally, there are potential cardiovascular risks. The ad-com documents start in on all the black-box warnings, patient monitoring, pharmacist education programs and so on that Valeant will have to do if the drug were to actually get approved, but the subtext is pretty clear: maybe we could save all this trouble by, you know, not approving it in the first place. It’s not like there are no other options; several therapies with good efficacy data are out there, and they don’t make people hang themselves, as far as anyone knows. . .

    blogs.sciencemag.org/pipeline/archive...
  5. [verwijderd] 20 juli 2016 00:47

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    Valeant Pharmaceuticals International Inc. VRX, +0.17% and Progenics Pharmaceuticals Inc. PGNX, -8.52% said late Tuesday the Food and Drug Administration approved their drug Relistor to treat opioid-induced constipation. Valeant shares rose 3.4% to $24.35 after hours, while Progenics shares jumped 17% to $5.80. Progenics licenses Relistor to Valeant, who plans to start marketing the drug in the U.S. in the third quarter. Earlier Tuesday, Valeant said an FDA panel recommended approval for a psoriasis treatment it licenses from AstraZeneca.

    www.marketwatch.com/story/valeant-pro...
  6. [verwijderd] 20 juli 2016 20:13

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    The FDA Showing Valeant Some Love With Recent Drug Approvals
    Today 1:58 PM ET (Benzinga)

    Valeant Pharmaceuticals Intl Inc (NYSE: VRX)'s stock got a boost on Wednesday after the U.S. Food and Drug Administration (FDA) approved the company's RELISTOR Tablets for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.

    Valeant said in a press release that it will commence sales of the new drug in the United States during the third quarter of 2016.

    Neil Maruoka of Canaccord Genuity commented in a research note on Wednesday that the FDA's approval of Relistor should be viewed as an "incremental positive" and a "small degree of vindication" for Valeant's R&D-lite model.
  7. [verwijderd] 22 juli 2016 14:49

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    BRIEF-FDA to inspect Nicox partner Bausch + Lomb
    Nicox SA :

    * Has been informed by its partner Bausch + Lomb, a Valeant unit, of receipt of a complete response letter from U.S. FDA concerning latanoprostene bunod

    * FDA's letter did not identify any efficacy or safety concerns with respect to NDA or additional clinical trials needed for approval of NDA for latanoprostene bunod ophthalmic solution, 0.024 pct

    * Concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida

    * Some deficiencies were identified by the FDA at the Tampa plant

    * Valeant intends to meet with FDA as soon as possible to work on a resolution and address these concerns Source text for Eikon: Further company coverage: (Gdynia Newsroom)
  8. [verwijderd] 2 augustus 2016 19:39

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    Shareholder Letter

    02 August 2016

    Dear Nicox Shareholder,

    As you may have noticed this has been without doubt an intense few weeks for Nicox, with the US FDA granting Priority Review for our New Drug Application (NDA) for AC-170 on June 18th, followed by the signing of an innovative agreement with GHO Capital for the future development of our European Commercial operations on July 4th. Two weeks later, on July 21st, our partner Valeant / Bausch + Lomb received a Complete Response Letter (CRL) from the FDA concerning the NDA for latanoprostene bunod, our highly promising new intraocular pressure lowering eye drop, citing some concerns related to a Bausch + Lomb manufacturing facility in Tampa.

    While we are of course disappointed not to have received the NDA approval yet because of these very specific concerns, we were pleased that the FDA’s Letter did not identify any efficacy or safety concerns or the need for any additional clinical trials for the approval of the NDA. The only reasons identified for the delay in the approval were the concerns raised by the FDA pertaining to a Current Good Manufacturing Practices (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida.

    We understand that Valeant will be meeting with the FDA to discuss the CRL. We have been told that Valeant is working diligently to satisfy the observations made by the FDA for the Tampa plant. In the meantime, Valeant continues to manufacture other products in the Tampa plant and distribute them to the market. Valeant plans to provide updates as appropriate. We expect latanoprostene bunod will receive FDA approval and we will continue to support Bausch + Lomb. We are also confident that approval will validate Nicox’s proprietary nitric oxide (NO)-donating research platform in the reduction of intraocular pressure (IOP) and we are committed to progressing our innovative development programs in this area.

    I am as well particularly delighted that a number of specialist healthcare investors share our optimism about the potential for latanoprostene bunod and AC-170, as well as for the rest of our highly promising pipeline, enabling us to complete an additional financing of € 18 million (gross proceeds) to pursue our focused R&D strategy. The funds raised give us the financial strength to proceed with the development of our other key pipeline assets without delay. We plan to accelerate the development of our extensive R&D pipeline including NCX 4251 for blepharitis, NCX 470 for the treatment of elevated IOP – both of which we expect will start in phase 2 clinical studies by the second half of 2017 – and the next generation of promising stand-alone NO donors.

    I want to thank you all once more for your continued support and we look forward to updating you on our progress.

    Sincerely yours,

    Michele Garufi
    Chairman and CEO
  10. [verwijderd] 9 augustus 2016 14:00

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    LAVAL, Que. — Valeant Pharmaceuticals International Inc is reporting a US$302 million net loss for its second quarter — nearly six times bigger than during the same period last year.

    The Quebec-based company — which reports in U.S. currency — also had lower adjusted earnings, which fell to $488 million from $751 million in the second quarter of 2015.

    Revenue fell by 11 per cent to $2.42 billion from $2.73 billion, mainly because of reduced sales from its existing businesses and a negative impact from a shift in foreign exchange rates. Acquired businesses provided a partial offset.

    Related
    Valeant Pharmaceuticals International Inc names new general counsel, says PR head to leave
    Valeant’s Relistor drug said to draw interest of potential buyers
    Why one FDA snag is moving Valeant Pharmaceuticals investors more than two successes
    One bright point for the company, which has seen its value plunge over the past year as a result of numerous issues, was an increase in cash flow from operations. It was up nine per cent to $448 million.

    The company also said it’s on track to meet the previously announced financial objectives for 2016.

    In pre-market trading, Valeant shares were up about seven per cent from Monday’s close at US$22.45 on the New York Stock Exchange.

    Despite missing estimates, the drugmaker maintained the financial forecasts it gave in June. Adjusted Ebitda for the year will be US$4.8 billion to US$4.95 billion. That forecast is a key metric for investors who are watching as the company works to repay a mountain of debt built up through acquisitions. Ebitda stands for earnings before interest, taxes, amortization and depreciation. Valeant also maintained its revenue and earnings per share forecasts. Analysts had been projecting a cut.

    Valeant’s recently installed chief executive officer, Joseph Papa, says the company is making progress on stabilizing the organization.

    “Although it will take time to implement and execute our turnaround plan, I am confident that we will show progress in the coming quarters,” Papa said in a statement ahead of a conference call with analysts.

    Valeant also announced the divestiture or agreement to sell assets such as the European rights to psoriasis drug brodalumab; the U.S. equipment manufacturing arm of Synergetics, part of eye-care company Bausch & Lomb; and drug Ruconest. The divestitures will bring in US$181 million, with the potential for US$329 million in additional payments dependent on sales milestones and approvals.

    Valeant’s stock has lost more than 90 percent of its value in the last year after scrutiny of its prices led the drugmaker to cut ties with a pharmacy that allegedly used aggressive tactics to boost sales, and Congress and U.S. regulators began investigating the company’s practices. The Laval, Quebec-based drugmaker inked a new distribution deal with Walgreens Boots Alliance Inc. earlier last year, but said in June that it was losing money on some prescriptions sold through the pharmacy chain.
  11. [verwijderd] 9 augustus 2016 14:31

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    Valeant Posts a Loss, Says It Will Retool--Update
    Today 8:28 AM ET (Dow Jones)Print
    By Anne Steele

    Valeant Pharmaceuticals International Inc. posted a wider loss in its latest quarter, and the company said it would reorganize, continuing a push to remake itself as a normal pharmaceutical firm.

    The company also affirmed its yearly guidance after a string of cuts, easing fears of triggering a debt-covenant breach. Shares in the company added 6% premarket to $23.80.

    It has been just over a full year since Valeant shares hit an all-time closing high. Since that peak last August at $262.52, the stock has erased more than 90% of its value amid a slate of concerns, including drug-price hikes, accounting problems, a brush with a potential debt default, and investigations by Congress and federal regulators.

    Investors have been watching for signs of what kind of profitability Valeant can deliver as it distances itself from big acquisitions and severe price increases for its drugs, the method it used to build its business.

    Chief Executive Joseph Papa, who took the helm from Michael Pearson in May, said Valeant would be going in a "new strategic direction" that involves reorganizing the company and its reporting segments.

    Valeant said in an investor presentation that, as part of its reorganization, it is looking at potential alternatives for some non-core businesses with revenue totaling more than $2 billion. Through asset sales and cash flow, the company said it looks to shore up its balance sheet by cutting its debt by more than $5 billion over the next year and a half.

    "We continue to make progress towards stabilizing the organization," Mr. Papa said. "Although it will take time to implement and execute our turnaround plan, I am confident that we will show progress in the coming quarters."

    For the quarter ended in June, Valeant posted a loss of $302.3 million, or 88 cents a share, wider than its loss of $53 million, or 15 cents a share, a year earlier.

    On an adjusted basis that strips out some costs and uses a new tax-reporting method, earnings fell to $1.40 a share from $2.14. Revenue slid 11% to $2.42 billion. Analysts were looking for adjusted earnings of $1.48 a share on $2.46 billion in revenue, according to Thomson Reuters.

    Valeant backed its guidance for the year -- which it had cut sharply in June -- for earnings of $6.60 to $7 a share and revenue between $9.9 billion and $10.1 billion. By backing its guidance, Valeant essentially said it thinks it can earn enough to keep its financial ratios in compliance with its debt covenants.

    But Evercore analyst Umer Raffat points out the lower-than-consensus results in the second quarter mean business has to improve in the second half to meet guidance. And some important segments struggled in the latest quarter.

    Dermatology revenue more than halved while ophthalmology skidded 25% lower. Neurology and branded generics revenue slipped 11%; gastrointestinal fell 10%.

    Developed-market revenue fell 14%, mostly owing to lower pricing. Valeant has faced fierce criticism for its drug pricing after The Wall Street Journal reported in April last year that the company had raised the prices of Isuprel and Nitropress, two cardiac-care drugs, by 525% and 212%, respectively, after acquiring the rights to the medicines.

    In May, Valeant said it would expand discounts for the pair of heart drugs following heavy scrutiny over its pricing tactics. It has also formed a committee to determine drug prices.

    Valeant also said it reached a deal to sell all North American commercialization rights to angioedema treatment Ruconest to Pharming Group NV for $60 million upfront and additional sales-based milestone payments of up to $65 million.

  12. [verwijderd] 9 augustus 2016 15:37

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    www.bloomberg.com/news/articles/2016-...

    ..................The company will be reorganized into three parts: Branded Rx, Bausch & Lomb/International, and U.S. Diversified products. Many of the company’s biggest drug categories saw declining sales, including in dermatology and prescription ophthalmology. Papa said the company is working to rebuild relationships with doctors and reduce employee turnover.
    Asset Divestitures
    He also laid out a plan for future divestitures, proceeds from which could be used to pay down debt. The company is examining assets with revenue worth more than $2 billion, Papa said, that could be worth about $8 billion in a sale.
    “This excludes our core assets,” Papa said. “We don’t have a plan to sell them -- we are exploring our strategic options with some bankers we’ve asked to help us.”...................
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