On May 8, 2018 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant" or the "Company" or "we") reported its first-quarter 2018 financial results (Press release, Valeant, MAY 8, 2018, http://ir.valeant.com/news-releases/2018/05-08-2018-120156169 [SID1234526270]).

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"Our first-quarter 2018 results demonstrate that we are making significant progress in our turnaround. For the first time since 2015, the Company delivered overall organic revenue growth2 that tracked above expectations and was driven by our Branded Rx and Bausch + Lomb/International segments," said Joseph C. Papa, chairman and CEO, Valeant. "As a result, we are raising our full-year revenue and Adjusted EBITDA (non-GAAP) guidance ranges to reflect our strong performance in the first quarter."

Company Highlights

Executing on Core Businesses and Advancing Pipeline

Reported revenue in the Bausch + Lomb/International segment decreased by 3% compared to the first quarter of 2017 primarily due to divestitures and discontinuations; revenue in this segment grew organically2 by 2% compared to the first quarter of 2017
Grew revenue in the Global Vision Care business by 15% compared to the first quarter of 2017; revenue in this business grew organically2 by 9% compared to the first quarter of 2017
Grew revenue in the aggregate in China by 24% compared to the first quarter of 2017; revenue in this business grew organically2 by 15% compared to the first quarter of 2017
Launches underway for additional two of the "Significant Seven" products, including:
VYZULTA, a treatment option for glaucoma
LUMIFY, the only over-the-counter eye drop with low-dose brimonidine for the treatment of eye redness
Reported revenue in the Branded Rx segment decreased by 6% compared to the first quarter of 2017 primarily due to divestitures and discontinuations, and declines in the Ortho Dermatologics business; revenue in this segment grew organically2 by 8% compared to the first quarter of 2017
Grew revenue in the Salix business by 40% compared to the first quarter of 2017
XIFAXAN revenue increased by 49% compared to the first quarter of 2017
RELISTOR franchise revenue increased by 54% compared to the first quarter of 2017
APRISO revenue increased by 31% compared to the first quarter of 2017
UCERIS franchise revenue increased by 27% compared to the first quarter of 2017
The U.S. Food and Drug Administration (FDA) approved PLENVU, a 1-liter bowel cleansing preparation for colonoscopies, which is expected to be available in the third quarter of 2018
Continued to stabilize the Ortho Dermatologics business
Increased dermatology sales force by approximately 25% in January 2018
Expanded the SILIQ launch after executing REMS certifications for more than 2,500 physicians, which includes more than 50% of the target prescribers
Launched RETIN-A MICRO 0.06% topical treatment for acne in January 2018 with sales tracking above the Company’s expectations
The FDA accepted New Drug Applications for:
ALTRENO3 (IDP-121), an acne treatment in lotion form; PDUFA action date of Aug. 27, 2018
BRYHALI3 (IDP-122), a topical treatment for plaque psoriasis; PDUFA action date of Oct. 5, 2018
Pivotal efficacy and safety data for DUOBRII3 (IDP-118), a topical treatment for plaque psoriasis, was published in The Journal of the American Academy of Dermatology
Completed Phase 2 studies for IDP-120, a topical treatment for acne that contains a fixed dose combination of tretinoin and benzoyl peroxide gel; Phase 3 studies are expected to begin in the second half of 2018
Entered into an exclusive licensing agreement with Kaken Pharmaceutical Co., Ltd. to develop and commercialize products containing a new chemical entity that, if approved, would represent a novel drug with an alternate mechanism of action in the topical treatment of psoriasis
Reducing Debt and Extending Maturities

Repaid approximately $280 million of debt with cash on hand in the first quarter of 2018
Repaid $200 million of the Company’s senior secured term loans, using cash on hand, in January 2018
Redeemed remaining $71 million aggregate principal amount of our outstanding 7.000% Senior Unsecured Notes due 2020, using cash on hand, on March 30, 2018
Issued $1.5 billion aggregate principal amount of 9.250% senior notes due 2026 on March 26, 2018
Used net proceeds, along with cash on hand, to repurchase, through cash tender offers, approximately $1.45 billion aggregate principal amount of outstanding Senior Notes due 2020 and 2021, and to pay fees and expenses
Resolving Legal Issues

Achieved dismissals or other positive outcomes in resolving and managing litigation and investigations in approximately 20 matters since Jan. 1, 2018
The UCERISarbitration was decided in favor of Valeant with the Arbitral Tribunal issuing a ruling that rejected the other party’s claims and ordering that they pay the entirety of Valeant’s legal costs
Agreed to resolve the SOLODYNantitrust litigations, with the class settlement ($58 million) being subject to final court approval
Agreed to resolve California Department of Insurance matter relating to Philidor, with no finding of admission or liability by Valeant
Summary judgment granted that upheld validity of RELISTOR Injection patent, U.S. Patent No. 8,552,025, preventing generic competition until 2024
First-Quarter 2018 Revenue Performance
Total reported revenues were $1.995 billion for the first quarter of 2018, as compared to $2.109 billion in the first quarter of 2017, a decrease of $114 million, or 5%. Excluding the impact of the 2017 divestitures and discontinuations of $214 million and the favorable impact of foreign exchange of $66 million, revenue grew organically2 by 2% compared to the first quarter of 2017, primarily driven by growth in the Salix business and the Bausch + Lomb/International segment. Organic2 revenue growth was partially offset by declines in the Ortho Dermatologics business and lower volumes in the U.S. Diversified Products segment, attributed to the previously reported loss of exclusivity for a basket of products.

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.103 billion for the first quarter of 2018, as compared to $1.134 billion for the first quarter of 2017, a decrease of $31 million, or 3%. Excluding the impact of divestitures and discontinuations of $113 million, and the favorable impact of foreign exchange of $65 million, the Bausch + Lomb/International segment grew organically2 by approximately 2% compared to the first quarter of 2017.

Branded Rx Segment
Branded Rx segment revenues were $593 million for the first quarter of 2018, as compared to $629 million for the first quarter of 2017, a decrease of $36 million, or 6%. Excluding the impact of divestitures and discontinuations of $83 million and the favorable impact of foreign exchange of $1 million, the Branded Rx segment grew organically2 by approximately 8% compared to the first quarter of 2017. Compared to the first quarter of 2017, the Salix business grew revenue by 40%, largely driven by sales growth in XIFAXAN and other promoted products.

U.S. Diversified Products Segment
U.S. Diversified Products segment revenues were $299 million for the first quarter of 2018, as compared to $346 million for the first quarter of 2017, a decrease of $47 million, or 14%. The decline was primarily driven by decreases attributed to the previously reported loss of exclusivity for a basket of products and by the impact of the 2017 divestitures and discontinuations of $18 million.

Operating Loss
Operating loss was $2.281 billion for the first quarter of 2018, as compared to an operating income of $211 million for the first quarter of 2017, a decrease of $2.492 billion. The decrease in operating results for the first quarter of 2018 primarily reflects goodwill impairment charges of $2.213 billion related to the Salix and Ortho Dermatologics businesses. These charges were recognized when the Company adopted new accounting guidance from the Financial Accounting Standards Board in January 2018.

Net Loss
Net loss for the three months ended March 31, 2018 was $2.693 billion, as compared to net income of $628 million for the same period in 2017, a decrease of $3.321 billion. The decrease in net income is primarily attributed to a decrease in the benefit from income taxes and the goodwill impairment charges recorded in the first quarter of 2018. Net income in the first quarter of 2017 included an income tax benefit of $908 million from a non-cash internal restructuring in that quarter.

Adjusted net income (non-GAAP) for the first quarter of 2018 was $312 million, as compared to $273 million for the first quarter of 2017, an increase of 14%.

Operating Cash
The Company delivered $438 million in operating cash in the first quarter of 2018, which was above expectations due to reductions in working capital and despite settlement payments of $170 million that were made in the first quarter for certain legacy legal matters, including the SOLODYN Antitrust Class Actions and Allergan Shareholder Class Actions.

Cash flow in the first quarter of 2018 decreased by $516 million, as compared to $954 million in the first quarter of 2017. The first quarter of 2017 included a one-time cash receipt attributed to our fulfillment agreement with Walgreens.

EPS
GAAP Earnings Per Share (EPS) Diluted for the first quarter of 2018 was $(7.68), as compared to $1.79 for the first quarter of 2017.

Adjusted EBITDA(non-GAAP)
Adjusted EBITDA (non-GAAP) was $832 million for the first quarter of 2018, as compared to $861 million for the first quarter of 2017, a decrease of $29 million, primarily driven by the impact of the 2017 divestitures of $75 million, offset by growth in the Salix business.

2018 Financial Outlook
Valeant has raised guidance for the full year of 2018 and has not changed anticipated dates for products losing exclusivity (LOE) later this year:

Full-Year Revenues in the range of $8.15 – $8.35 billion from $8.10 – $8.30 billion
Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.15 – $3.30 billion from $3.05 – $3.20 billion
Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP). The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

Additional Highlights

Valeant’s cash and cash equivalents were $909 million at March 31, 2018
The Company’s availability under the Revolving Credit Facility was approximately $1.1 billion at March 31, 2018
Conference Call Details

Date:

Tuesday, May 8, 2018

Time:

8:00 a.m. EDT

Web cast:

http://ir.valeant.com/events-and-presentations

Participant Event Dial-in:

(844) 428-3520 (North America)

(409) 767-8386 (International)

Participant Passcode:

6185877

Replay Dial-in:

(855) 859-2056 (North America)

(404) 537-3406 (International)

Replay Passcode:

6185877 (replay available until July 8, 2018)

On May 8, 2018 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant" or the "Company" or "we") reported that the Company will change its name to Bausch Health Companies Inc., effective in July 2018 (Press release, Valeant, MAY 8, 2018, http://ir.valeant.com/news-releases/2018/05-08-2018-120255538 [SID1234526269]).

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"Becoming Bausch Health Companies is a major step forward in our transformation," said Joseph C. Papa, chairman and CEO, Valeant. "The Bausch name embodies the rich history of innovation, fortitude and dedication to patient health dating back to when J.J. Bausch opened his first optical goods shop more than 165 years ago. These qualities form the foundation of who we are today as we continue to build an innovative company striving to improve the health of patients globally."

Since joining Valeant in May 2016, Mr. Papa and his leadership team have embarked on a multi-year effort to turnaround the Company. In the past two years, the Company has completed more than a dozen divestitures to strategically streamline operations, has reduced debt by more than 20%, and has resolved numerous legacy issues.

"Now is the right time in our turnaround to unite our Company’s core businesses, subsidiaries and brands under the Bausch Health name," continued Mr. Papa. "We believe Bausch Health Companies more accurately represents the full scope of the Company today – a leader in the development and manufacture of a wide range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology."

Because the Company’s businesses and subsidiaries have strong brand equity, all entities that have separate established brands will continue to operate under the corporate umbrella using their existing names.

As part of the name change, the Company will roll out a new corporate brand identity in July 2018, which will include new imagery and web site, and will trade under a new symbol, BHC. Until that time, the Company will continue to trade on the New York Stock Exchange and Toronto Stock Exchange under its present symbol, VRX.

"We completed an extensive assessment of the name entities available from within our portfolio and also assessed several potential new names. As our review progressed, it became clear that Bausch Health Companies best represents the company we are today," said Mr. Papa. "With a history that ranges from creating revolutionary Vulcanite eye glass frames in 1861 to being the first to mass produce and market soft contact lenses globally in 1971, the Bausch brand is synonymous with innovation and quality."

Notice of the name change has been submitted to both the New York Stock Exchange and the Toronto Stock Exchange, and the effectiveness of the name change is subject to the satisfaction of customary conditions of such exchanges.

On May 8, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its first quarter 2018 financial results for the period ended March 31, 2018 (Press release, Merrimack, MAY 8, 2018, View Source [SID1234526268]).

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"At Merrimack, we set out to design targeted solutions with pharmacological properties to match our team’s understanding of cancer pathways and drug metabolism. We have been focused on executing this strategy as we advance the ten wholly-owned programs across our clinical and preclinical pipeline, each addressing biomarker-defined cancers," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "We look forward to our three upcoming clinical readouts: randomized Phase 2 data for istiratumab (MM-141) in pancreatic cancer and seribantumab (MM-121) in non-small cell lung cancer and Phase 1 data for MM-310 in solid tumors."

First Quarter and Recent Highlights

Key events from the first quarter and more recently include:

Appointment of Lee Newcomer, M.D., M.H.A., former Senior Vice President for Oncology and Genetics and Chief Medical Officer at UnitedHealthcare and board-certified medical oncologist, to Merrimack’s Scientific Advisory Board (SAB). Dr. Newcomer, with his perspective on medical oncology and patient access, joins distinguished experts in precision oncology, bioengineering, drug discovery and clinical development on Merrimack’s SAB; and

Presentation of preclinical data at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Merrimack hosted four poster sessions, highlighting preclinical data from MM-310 as well as other preclinical programs currently in development.
Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

Top-line results in the first half of 2018 from the CARRIE study, an event-driven, randomized Phase 2 clinical trial evaluating istiratumab (MM-141) added to standard of care in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1;

Top-line results in the second half of 2018 from the SHERLOC study, an event-driven, randomized Phase 2 clinical trial evaluating seribantumab (MM-121) added to standard of care in patients with heregulin positive non-small cell lung cancer; and

Safety data and maximum tolerated dose in the second half of 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.
First Quarter 2018 Financial Results

The following summarizes Merrimack’s financial results for the three months ended March 31, 2018:

Research and development expenses for the three months ended March 31, 2018 were $13.1 million, compared to $21.6 million for the three months ended March 31, 2017. Research and development spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to Merrimack’s refocused clinical and preclinical pipeline;

General and administrative expenses for the three months ended March 31, 2018 were $4.3 million, compared to $5.6 million for the three months ended March 31, 2017. General and administrative spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to a decrease in corporate expenses related to headcount levels following the asset sale to Ipsen S.A.;

Net loss from operations for the three months ended March 31, 2018 was $17.8 million, or $1.33 per share, compared to a net loss from continuing operations of $28.7 million, or $2.20 per share, for the three months ended March 31, 2017;

As of March 31, 2018, Merrimack had cash and cash equivalents and marketable securities of $76.3 million, compared to $93.4 million as of December 31, 2017; and

As of March 31, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.
Financial Outlook

Merrimack continues to believe that its cash and cash equivalents and marketable securities of $76.3 million as of March 31, 2018 and certain potential net milestone payments anticipated from Shire will be sufficient to fund its planned operations into the second half of 2019.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Tuesday, May 8, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 1596995. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

On May 8,2018 AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the European Medicines Agency (EMA) has approved LYNPARZA (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status (Press release, Merck & Co, MAY 8, 2018, View Source [SID1234526267]).

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Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca, said, "With this new approval for LYNPARZA, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterized safety and tolerability profile."

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease. Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women."

The EU approval was based on two randomized trials, SOLO-2 and Study 19, which showed that LYNPARZA reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.

On May 8, 2018 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2018 (Press release, Vericel, MAY 8, 2018, View Source [SID1234526266]).

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First Quarter 2018 Financial Highlights

Total net revenues of $18.0 million compared to $9.4 million in the first quarter of 2017; first quarter 2017 revenues included a $2.8 million revenue reserve for Carticel and MACI related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer;

Gross margins of 57% compared to gross margins of 24% in the first quarter of 2017;

Net loss of $7.7 million, or $0.21 loss per share, which included warrant-related expense of $2.9 million, compared to net loss of $9.8 million, or $0.31 per share, in the first quarter of 2017, which included $0.1 million of warrant income;

Non-GAAP adjusted EBITDA loss of $2.6 million compared to a loss of $5.9 million in the first quarter of 2017; and

As of March 31, 2018, the company had $29.8 million in cash compared to $26.9 million in cash at December 31, 2017.

Recent Business Highlights
During and since the first quarter of 2018, the company:

Achieved record first quarter revenues and the fourth straight quarter of 30% or greater revenue growth versus the same quarter of the prior year;

Achieved the Company’s first quarter of positive operating cash flow;

Deployed the expanded MACI (autologous cultured chondrocytes on porcine collagen membrane) sales force, which increased from 28 to 40 sales representatives;

Launched the MACI ‘It’s Your Move’ campaign in partnership with world champion swimmer, five-time Olympian, and best-selling author Dara Torres; and

Announced the publication of results from the Phase 3 SUMMIT Extension Study in the American Journal of Sports Medicine demonstrating sustained clinical benefit of MACI out to five years.
"We had a strong start to 2018 with significant revenue growth for both MACI and Epicel, and delivered the fourth straight quarter of 30% or higher revenue growth compared to the same quarter of the prior year," said Nick Colangelo, president and CEO of Vericel. "We also reported significant margin improvements and generated the Company’s first quarter of positive operating cash flow as we continue to move our current business towards sustained profitability."

First Quarter 2018 Results
Total net revenues for the quarter ended March 31, 2018 were $18.0 million, which included $12.1 million of MACI net revenue and $6.0 million of Epicel (cultured epidermal autografts) net revenue, compared to $5.0 million of Carticel (autologous cultured chondrocytes) and MACI net revenue and $4.4 million of Epicel net revenue, respectively, in the first quarter of 2017. Total net revenues for the quarter ended March 31, 2017 included a $2.8 million revenue reserve for Carticel and MACI related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer. Total net revenues increased 93% compared to the first quarter of 2017, with MACI revenue increasing 141% and Epicel revenue increasing 37%, respectively, compared to the same period in 2017. Excluding the revenue reserve in the first quarter of 2017, non-GAAP net revenues increased 49%, with MACI revenue increasing 55% compared to first quarter of 2017.
Gross profit for the quarter ended March 31, 2018 was $10.4 million, or 57% of net revenues, compared to $2.3 million, or 24% of net revenues, for the first quarter of 2017.
Total operating expenses for the quarter ended March 31, 2018 were $14.7 million compared to $11.9 million for the same period in 2017.
Loss from operations for the quarter ended March 31, 2018 was $4.3 million, compared to a loss of $9.6 million for the first quarter of 2017. Material non-cash items impacting the operating loss for the quarter included $1.3 million of stock-based compensation expense and $0.4 million in depreciation expense.
Other expense for the quarter ended March 31, 2018 was $3.3 million compared to $0.2 million for the same period in 2017. The change in other expense for the quarter is primarily due to a $2.9 million change in the fair value of warrants.
Non-GAAP adjusted EBITDA loss was $2.6 million for the quarter ended March 31, 2018 compared to a loss of $5.9 million in the same period in 2017. See table reconciling non-GAAP measures for more details.
Vericel’s net loss for the quarter ended March 31, 2018 was $7.7 million, or $0.21 per share, compared to a net loss of $9.8 million, or $0.31 per share, for the same period in 2017.

2

As of March 31, 2018, the company had $29.8 million in cash compared to $26.9 million in cash at December 31, 2017.
"Our first quarter results demonstrated continued momentum moving into our second year with MACI on the market and that investments made in Epicel are continuing to drive additional utilization," added Mr. Colangelo. "We believe that an expanded MACI sales force in 2018, together with patient-focused marketing initiatives, will further strengthen our position in the market and build the foundation for strong revenue growth in the years ahead."
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first-quarter 2018 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until May 8, 2019. A replay of the call will also be available until 11:30am (EST) on May 13, 2018 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 1564056.