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.

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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.

On May 8, 2018 Pieris Pharmaceuticals, Inc. presented Deutsche Bank Health Care Conference presentation (Presentation, Pieris Pharmaceuticals, MAY 8, 2018, View Source [SID1234526265]).

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