Valeant Pharmaceuticals (VRX) : psoriasis treatment rejection by FDA

• Note: Valeant Pharma (VRX) has been renamed Bausch Health (NYSE:BHC)  (July 2018)

 

 Valeant Pharma receives Complete Response Letter (CRL) regarding the New Drug Application for DUOBRII (IDP-118) lotion in the treatment of plaque psoriasis
"The CRL did not specify any deficiencies related to the clinical efficacy or safety of DUOBRII and no issues with CMC* processes. The CRL only noted questions regarding pharmacokinetic data," said Joseph C. Papa, chairman and CEO, Valeant. "We are working to resolve this matter expeditiously and have already requested a meeting with the FDA. We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible."

Valeant Pharmaceuticals (VRX) to be renamed Bausch Health Companies

 

• The change to Bausch Health Companies Inc. and the new ticker BHC, is scheduled for July. 

 

It will be the company’s second scandal-inspired name change in less than 10 years. In 2010, after the troubled pharmaceutical company Biovail acquired Valeant, and the combined company went by the name Valeant instead.

Rebranding is a time-honored tool for companies, giving them a fresh start and bringing them closer to what they want to be known for.

Andersen Consulting is now Accenture plc (NYSE:ACN), Philip Morris is Altria Group Inc (NYSE:MO), and most of what was once Enron is now Kinder Morgan Inc (NYSE:KMI).

In Valeant’s case, that would be its well-known Bausch + Lomb eye products line, which sells contact lenses, dry eye products, prescription eye products, surgical products and more. The business unit brought in $4.9 billion in revenue last year, making it by far Valeant’s biggest unit by revenue.

This week's biggest % winners & losers : Feb 26 - March 2, 18 (wk 9)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: MGNX (28.94 +23.36%), VEEV (73.77 +19.85%), ONCE (65.67 +19.36%), ACHN (3.51 +18.78%), NKTR (102.87 +14.81%), SGYP (2.17 +14.21%)
• Materials: TAHO (4.91 +23.06%)
• Industrials: STB (7.5 +19.43%)
• Consumer Discretionary: DDS (87.97 +23.33%), ETSY (25.71 +22.02%)
• Information Technology: UBNT (67.4 +18.25%), HLIT (3.45 +16.95%)
• Financials: PHH (10.62 +22.35%), NGHC (23.55 +16.87%)
• Energy: SWN (4.47 +19.52%), TUSK (28.42 +16.48%)
• Telecommunication Services: NIHD (1.28 +24.27%), I (4.76 +20.51%)

This week's top 20 % losers

• Healthcare: AKRX (18.97 -37.02%), PTLA (34.25 -25.25%), ACAD (23.68 -24.87%), PDCO (25.01 -22.47%), VRX (14.88 -20.34%), EGRX (53.63 -19.79%), EXEL (24.08 -18.4%), RDUS (32.92 -18.02%)
• Materials: ALB (95.02 -19.98%), SQM (47.85 -18.05%)
• Industrials: BW (5.53 -20.09%)
• Consumer Discretionary: NTRI (31.45 -24.31%), ODP (2.51 -18.77%)
• Information Technology: BOX (18.82 -19.3%)
• Energy: CRC (14.98 -25.95%), HK (5.35 -23.46%), CRZO (14.9 -19.2%)
• Consumer Staples: MNST (54.16 -17.79%)
• Telecommunication Services: FTR (7.00 -23.08%)

Valeant Pharma (VRX) reported earnings on Wed 28 Feb 18 (b/o)

  

Valeant Pharma beats by $0.02, reports revs in-line; guides FY18 revs below consensus

• Reports Q4 (Dec) earnings of $0.98 per share, excluding non-recurring items, $0.02 better than the Capital IQ Consensus of $0.96; revenues fell 10.0% year/year to $2.16 bln vs the $2.18 bln Capital IQ Consensus. 
  • The Bausch + Lomb/International segment comprised ~56% of the Company's revenue in 2017. Reported revenue decreased by 1% compared to 2016; excluding foreign exchange and divestitures, revenue grew organically by 6% compared to 2016. Generated mid-single digit organic growth during each of the four quarters of 2017
  • The Salix business, which is reported within the Branded Rx segment, comprised ~18% of the Company's revenue in 2017. Reported revenue grew by 2% and revenue grew organically by 5%, compared to 2016. Generated mid-single digit or higher organic growth during the second, third and fourth quarters of 2017
  • Continued to focus on stabilizing the dermatology business, which is reported within the Branded Rx segment Recruited new leadership team and rebranded the business as Ortho Dermatologics. Increased dermatology sales force by more than 25% in January 2018. Reduced total debt by more than $4.4 billion in 2017
• Co issues downside guidance for FY18, sees FY18 revs of $8.1-8.3 bln vs. $8.37 bln Capital IQ Consensus Estimate. EBITDA $3.05-3.20 bln. 

=Valeant Pharma (VRX) reported earnings on Tue 7 Nov 017 (b/o)

Valeant Pharma reports Q3 (Sep) results, beats on revs; lowers FY17 revs guidance, maintains Adj-EBITDA outlook

• Reports Q3 (Sep) GAAP earnings of $3.69 per share, may not be comparable to the Capital IQ GAAP Consensus of ($1.00); revenues fell 10.5% year/year to $2.22 bln vs the $2.17 bln Capital IQ Consensus.
  • Commentary on revenues: The decrease was primarily driven by decreases in volume in the U.S. Diversified Products and Branded Rx segments attributed to the previously reported loss of exclusivity for a basket of products and also reflects the impact of divestitures and discontinuations and the unfavorable impact of foreign exchange. The decline was partially offset by increased sales in our Bausch + Lomb/International segment and Salix business.
• Adjusted EBITDA (non-GAAP) was $951 million for the third quarter of 2017, as compared to $1,163 million for the third quarter of 2016, a decrease of $212 million, primarily due to revenue declines coming from the loss of exclusivity impact on the U.S. Diversified Products segment, volume declines in the Ortho Dermatologics business and the previously announced divestitures, partially offset by lower Selling, General and Administrative and Research and Development expenses.
• Co issues in-line guidance for FY17, sees FY17 revs of $8.65-8.8 bln (Prior $8.7-8.9 bln) vs. $8.69 bln Capital IQ Consensus Estimate, continues to see Adj-EBITDA of $3.6-3.75 bln despite asset divestitures 

=Valeant (VRX) to sell Obagi Medical Products business for $190 million

• Dr. Zein E. Obagi, M.D.  founded Obagi Medical Products. He is a board certified practicing dermatologist in Beverly Hills, California. Dr. Obagi received his M.D. from Damascus Medical School in 1972 and emigrated to the United States, where he interned in general medicine and completed a 2-year anatomic pathology residency.

(Reuters) - Valeant Pharmaceuticals International Inc (VRX) said on Monday it would sell its Obagi Medical Products business for $190 million in cash, as part of the Canadian drugmaker's efforts to cut down its debt.

Valeant, which bought the Irvine, California-based Obagi for about $344 million in 2013, will sell the business to Haitong International Zhonghua Finance Acquisition Fund I LP.

The Obagi Medical Products unit includes skin-care products designed to help minimize the appearance of premature skin aging, skin damage and hyperpigmentation, the company said.

Proceeds from the deal, which is expected to close in the second half, will be used to further repay term loan debt, Valeant said.

U.S.-listed shares of the company reversed course and were up 1.2 percent at $17.45 in premarket trading. They had gained about 37 percent since June 1.

The drugmaker has been looking to reduce its debt pile of about $29 billion as of March 31, following a furious spate of deal-making under former CEO Mike Pearson.

Valeant said last week it paid down $811 million of debt with proceeds from the sale of its cancer treatment unit Dendreon Pharmaceuticals.

Limited partners of the Haitong fund include industry veterans in other geographic markets, such as China Regenerative Medicine International Ltd (8158.HK).

Morgan Stanley is Valeant's financial adviser, while Norton Rose Fulbright the legal adviser.

Valeant Pharmaceuticals (VRX) reported earnings on Tue 9 May 17 (b/o)

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(Reuters) - Canada's Valeant Pharmaceuticals International Inc (VRX) raised its 2017 earnings forecast and reported its first profit in six quarters, helped by a one-time tax gain, and its U.S. shares jumped nearly 21 percent.

The maker of Bausch + Lomb contact lenses and irritable bowel treatment Xifaxan is trying to regain investor confidence after investigations into its drug pricing and other business practices, such as its use of a specialty pharmacy, by multiple U.S. government agencies.

Laval, Quebec-based Valeant said it expected 2017 earnings before interest, tax, depreciation and amortization of $3.60 billion to $3.75 billion, excluding special items. It previously forecast $3.55 billion to $3.70 billion.

The outlook cheered investors who may have expected a reduction, said BTIG analyst Tim Chiang.

"The market was very fearful that something else was going to go wrong," Chiang said. "Maybe management is getting their hands around the situation. Still, they have this uphill climb."

The results came after billionaire investor William Ackman sold his entire stake in Valeant in March at a loss of more than $3 billion.

Valeant is focusing on its dermatology, eyecare and gastrointestinal units while selling other assets to repay heavy debt.

Despite challenges, the company is "the turnaround opportunity of a lifetime" as it fixes its balance sheet, Chief Executive Officer Joe Papa told analysts.

Valeant's shares were up 20.6 percent at $11.71 in New York. At Monday's close, they had fallen 70 percent since August.

The drugmaker reduced its long-term debt by $1.3 billion in the first quarter, leaving it at $28.54 billion on March 31.

Refinancing has created a more comfortable repayment schedule, Chief Financial Officer Paul Herendeen said.

Net income was $628 million, or $1.79 per share, in the quarter, compared with a year-earlier loss of $374 million, or $1.08 per share.

The results included a one-time income tax benefit of $908 million from internal restructuring.

On a per-share basis, Valeant's earnings were 78 cents, excluding items, below the analysts' average estimate of 82 cents, according to Thomson Reuters I/B//E/S.

Revenue fell to $2.11 billion from $2.37 billion, missing the average estimate of $2.18 billion.

Revenue at Valeant's branded Rx unit fell 9 percent to $604 million. The company said a decrease in volume offset higher prices.

Valeant (VRX) : Ackman exit fails to sway valuation expert

Valeant Pharmaceuticals International Inc. has enough value left for Aswath Damodaran to maintain a stake. The New York University professor and author of four books about company valuation disclosed in a blog posting Thursday that he still owns shares bought last year, before Valeant dropped to its lowest price since 2009 and investor Bill Ackman sold his entire holding at a loss. Damodaran estimated the drugmaker’s value as a going concern at $13.68 a share, 26 percent higher than Thursday’s close -- and 35 percent lower than his average cost of about $21.

Valeant Pharmaceuticals (VRX) reported earnings on Tue 28 Feb 17 (b/o)

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LAVAL, Quebec (AP) _ Valeant Pharmaceuticals International Inc. (VRX) on Tuesday reported a loss of $515 million in its fourth quarter.

On a per-share basis, the Laval, Quebec-based company said it had a loss of $1.47. Earnings, adjusted for one-time gains and costs, came to $1.26 per share.

The results beat Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for earnings of $1.24 per share.

The drugmaker posted revenue of $2.4 billion in the period, also exceeding Street forecasts. Six analysts surveyed by Zacks expected $2.35 billion.

For the year, the company reported that its loss widened to $2.41 billion, or $6.94 per share. Revenue was reported as $9.67 billion.

Valeant expects full-year revenue in the range of $8.9 billion to $9.1 billion.

Valeant shares have risen 15 percent since the beginning of the year. The stock has decreased 80 percent in the last 12 months.

L'Oreal to pay $1.3B for Valeant skin-care brands

PARIS-- L'Oréal SA plans to buy CeraVe and two other skin-care brands (AcneFree and Ambi) from Valeant Pharmaceuticals Inc. for $1.3 billion, expanding the French cosmetics firm's U.S. presence and deepening its portfolio in a product segment that has become the beauty industry's largest.

• Earlier in the day, Valeant said it would sell its Dendreon Pharmaceuticals unit to closely held Chinese conglomerate Sanpower Group Co. for about $820 million.
• The agreements mark a start to Valeant's efforts to pay down about $30 billion in debt. The Laval, Quebec-based company has been embroiled in scandals about its drugs' high prices and accounting that led to legal and regulatory investigations along with declines in its share price. 
• The three brands have combined annual sales of about $168 million and will become part of L'Oreal's Active Cosmetics Division, alongside La Roche-Posay, Vichy and SkinCeuticals.
• Through Monday, 9 Jan 2017, Valeant's U.S. shares had plunged 94 percent from their 2015 peak, cutting the company's market value to $5.2 billion.

The all-cash deal will give L'Oréal the CeraVe brand, which includes cleansers, moisturizers and healing ointments, as well as the AcneFree and Ambi brands, which distribute a range of acne treatments and skin-care products.

L'Oréal, one of the world's leading cosmetics makers, said the three brands have an annualized combined revenue of around $168 million.

CeraVe offers a range of skin-care products including cleansers, moisturizers and sunscreens, as well as a baby line. It is one of the fastest-growing skin-care brands in the U.S., averaging 20% annual growth over the past two years, L'Oréal said.

L'Oréal said the three brands would stand alongside the likes of Vichy, La Roche-Posay and SkinCeuticals in its Active Cosmetics division, which has been growing in recent quarters, boosted by strong performances in North America and Latin America.

For Valeant, the sale is part of new Valeant Chief Executive Joseph Papa's efforts to focus the company on its key franchises by selling noncore assets or milking them for cash to pay down $30 billion in debt.

Valeant Pharma (VRX) reported earnings on Tue 8 Nov 2016 (b/o)

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Valeant Pharma misses by $0.21, misses on revs; cuts FY16 guidance:

• Reports Q3 (Sep) earnings of $1.55 per share, excluding non-recurring items, $0.21 worse than the Capital IQ Consensus of $1.76; revenues fell 11.0% year/year to $2.48 bln vs the $2.51 bln Capital IQ Consensus.
• "This past quarter, we made further progress toward establishing the new Valeant," said Joseph C. Papa, Chairman and Chief Executive Officer. "We have, where appropriate, begun to centralize some parts of the business, and hired two key senior executives: Paul Herendeen, Chief Financial Officer, and Dr. Louis Yu, Chief Quality Officer. We also have started to present our financial results under three operating and reportable segments, which we believe will help clarify areas of strength and provide additional transparency. While we have revised our expectations for the remainder of 2016, I continue to be encouraged by the commitment of our employees who work each day toward meeting our mission of helping improve people's lives through our healthcare products."
• Adjusted EBITDA (non-GAAP) for the third quarter of 2016 came in at $1.16 billion, an improvement over second quarter results of $1.09 billion and first quarter results of $1.01 billion.
• GAAP Cash flow from operations was $570 million in the third quarter of 2016 as compared to $733 million in the third quarter of 2015. On a sequential basis, GAAP Cash flow from operations was $557 million in the first quarter of 2016, $448 million in the second quarter and $570 million in the third quarter.
• Co lowers guidance for FY16, sees EPS of $5.30-5.50 (Prior $6.60-7.00) vs. $6.49 Capital IQ Consensus Estimate; sees FY16 revs of $9.55-9.65 bln (Prior $9.9-10.1 bln) vs. $9.93 bln Capital IQ Consensus Estimate, sees Adj-EBITDA of $4.25-4.35 bln (Prior $4.8-4.95 bln)

Valeant Pharma (VRX) reported earnings Tue 7 June 2016 (b/o)

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Valeant Pharma misses by $0.10, beats on revs; cuts FY16 EPS, revs guidance:

• Reports Q1 (Mar) earnings of $1.27 per share, $0.10 worse than the Capital IQ Consensus of $1.37; revenues rose 9.3% year/year to $2.37 bln vs the $2.34 bln Capital IQ Consensus.
• Co lowers guidance for FY16, sees EPS of $6.60-7.00 (Prior $8.50-9.50) vs. $8.51 Capital IQ Consensus Estimate; sees FY16 revs of $9.90-10.01 bln (Prior $11.0-11.2 bln) vs. $10.92 bln Capital IQ Consensus Estimate; Sees Adj-EBITDA of $4.80-4.95 bln (Prior $5.60-5.80 bln)
• "The first quarter's results reflect, in part, the impact of significant disruption this organization has faced over the past nine months," said Joseph Papa, chairman and chief executive officer. "This has been a difficult period for Valeant and its stakeholders, and while there are some challenges to work through in certain business operations in 2016, such as our U.S. dermatology unit, the majority of our businesses are performing according to expectations. While we recognize that we did not meet the timeline for filing our first quarter results, with our filing expected this week, we will be current in our financial reporting. We have made progress toward stabilizing the organization over the past few months, and we expect to file our financial results in a timely manner going forward."

Valeant Pharma (VRX) reported earnings on Tue 3/15/16 (b/o)

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Valeant Pharma misses by $0.12, reports revs in-line; offers downside Q1/FY16 EPS, revs guidance :

Reports Q4 (Dec) earnings of $2.50 per share, $0.12 worse than the Capital IQ Consensus of $2.62; revenues rose 22.3% year/year to $2.79 bln vs the $2.76 bln Capital IQ Consensus.

• Co lowers guidance for Q1, sees EPS of $1.30-1.55 (Prior $2.35-2.55) vs. $2.66 Capital IQ Consensus Estimate; sees Q1 revs of $2.3-2.4 bln ($2.8-3.1 bln) vs. $2.85 bln Capital IQ Consensus Estimate.
• Co lowers guidance for FY16, sees EPS of $9.50-10.50 (Prior $13.25-13.75) vs. $13.48 Capital IQ Consensus Estimate; sees FY16 revs of $11.0-11.2 bln (Prior $12.5-12.7 bln) vs. $12.54 bln Capital IQ Consensus Estimate.
• The co also offered guidance for the next four quarters (2Q16 - 1Q17), saying it expects revs to be $11.6-11.8 bln, and EPS of $10.75-11.25
• "The challenges of the past few months are not yet behind us and our goal for 2016 is to better balance our priorities across all of our constituencies - physicians, patients, employees, payors, debt holders and shareholders...In discussion with the Board, we have assumed lower growth in our U.S. dermatology, gastrointestinal, and woman's health portfolios, as well as certain geographies like Western Europe, while keeping our expenses largely unchanged. We plan to work hard to improve these metrics by delivering higher revenues and reducing our costs and, if successful, we hope to beat this guidance in the quarters to come. In the meantime, we are comfortable with our current liquidity position and cash flow generation for the rest of the year, and remain well positioned to meet our obligations."

Worth noting that while Valeant's guidance for Q1 and 2016 have been reduced from prior expectations, the company did announce upon the return of Michael Pearson that it was withdrawing all prior guidance.