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Jazz Pharmaceuticals Announces Participation in Two Upcoming Investor Conferences

On August 27, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentations at two upcoming investor conferences (Press release, Jazz Pharmaceuticals, AUG 27, 2019, View Source [SID1234539031]).

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Wells Fargo Securities Healthcare Conference in Boston on Wednesday, September 4, 2019 at 8:30 a.m. EDT / 1:30 p.m. IST. Daniel Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.
Morgan Stanley Annual Global Healthcare Conference in New York on Monday, September 9, 2019 at 8:45 a.m. EDT / 1:45 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
A live audio webcast of each presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of each webcast will be available for at least one week following each presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

Penumbra, Inc. to Present at the Morgan Stanley 17th Annual Global Healthcare Conference

On August 27, 2019 Penumbra, Inc. (NYSE: PEN) reported that its management team is scheduled to present at the Morgan Stanley 17th Annual Global Healthcare Conference in New York, NY on Tuesday, September 10, 2019 (Press release, Penumbra, AUG 27, 2019, View Source [SID1234539029]).

Event:

Morgan Stanley 17th Annual Global Healthcare Conference

Date:

Tuesday, September 10, 2019

Time:

1:30pm ET / 10:30am PT

A webcast of the presentation will be available by visiting the investors’ section of the company’s website at www.penumbrainc.com. The webcast will be available on the company’s website for at least two weeks following the event.

Lannett Announces Fiscal 2019 Fourth-Quarter, Full-Year Financial Results; Issues Guidance For Fiscal 2020

On August 27, 2019 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2019 fourth quarter and full year ended June 30, 2019 (Press release, Lannett, AUG 27, 2019, View Source [SID1234539028]).

"In fiscal 2019, we made excellent progress rebuilding our business," said Tim Crew, chief executive officer of Lannett. "We feel positive about our company’s future following a number of significant accomplishments. Since January 2018, we have launched 25 products with annualized sales of approximately $100 million, acquired or in-licensed more than 40 ANDAs and paid down approximately $187 million of our outstanding debt, which included $87 million of voluntary payments. In the past year, we have expanded existing strategic alliances and established new ones, and submitted to the FDA nine product applications, all while we implemented and recently completed a net $33 million cost savings plan.

"Financial results for our fiscal 2019 fourth quarter, the first full quarter of the fiscal year without sales of Levothyroxine, exceeded or were at the upper end of our expectations. The quarter did benefit from a few items that were related to timing.

"Looking ahead, we expect to launch a number of new products that will continue to build our business in the near term and have begun adding products to our pipeline that have significant potential in the medium term and beyond."

For the fiscal 2019 fourth quarter, on a GAAP basis, net sales were $133.8 million compared with $170.9 million for the fourth quarter of fiscal 2018. Gross profit was $49.3 million, or 37% of total net sales, compared with $66.5 million, or 39% of total net sales. Research and development (R&D) expenses were $9.4 million compared with $8.3 million for the fiscal 2018 fourth quarter. Selling, general and administrative (SG&A) expenses were $22.2 million compared with $20.6 million. Restructuring expenses were $2.4 million compared with $4.1 million. Asset impairment charges were $5.9 million compared with $25.0 million for the prior year fourth quarter. Operating income increased to $9.4 million from $8.6 million. Interest expense decreased to $20.2 million from $21.2 million for the fourth quarter of fiscal 2018. Net loss was $7.6 million, or $0.20 per share, compared with $11.4 million, or $0.30 per share, for the fiscal 2018 fourth quarter.

For the fiscal 2019 fourth quarter reported on a Non-GAAP basis, net sales were $133.8 million compared with $170.9 million for the fourth quarter of fiscal 2018. Adjusted gross profit was $59.8 million, or 45% of adjusted net sales, compared with $76.0 million, or 44% of adjusted net sales, for the prior-year fourth quarter. Adjusted R&D expenses were $8.6 million compared with $8.3 million. Adjusted SG&A expenses were $17.0 million compared with $17.4 million. Adjusted operating income was $34.1 million compared with $50.3 million for the prior-year fourth quarter. Adjusted interest expense was $16.0 million compared with $16.6 million for the fourth quarter of fiscal 2018. Adjusted net income was $14.7 million, or $0.37 per diluted share, compared with $24.5 million, or $0.64 per diluted share, for the fiscal 2018 fourth quarter.

For the fiscal 2019 full year, on a GAAP basis, net sales were $655.4 million compared with $684.6 million for the fiscal 2018 full year. Gross profit was $243.6 million, or 37% of total net sales, compared with $288.7 million, or 42% of total net sales. R&D expenses were $38.8 million compared with $29.2 million for the fiscal 2018 full year. SG&A expenses were $87.6 million compared with $82.2 million. Restructuring expenses were $4.1 million compared with $7.1 million. The company reported operating loss of $262.3 million, which included asset impairment charges of $375.4 million. This compares to fiscal 2018 full year operating income of $129.7 million, which included asset impairment charges of $25.0 million and a loss on sale of intangible asset of $15.5 million. Interest expense decreased to $84.6 million from $85.6 million. Net loss was $272.1 million, or $7.20 per share, versus net income of $28.7 million, or $0.75 per diluted share, for fiscal 2018.

For the fiscal 2019 full year reported on a Non-GAAP basis, net sales were $655.4 million compared with $684.6 million for the fiscal 2018 full year. Adjusted gross profit was $291.4 million, or 44% of adjusted net sales, compared with $326.2 million, or 48% of adjusted net sales, for the prior year. Adjusted R&D expenses were $36.1 million compared with $29.2 million. Adjusted SG&A expenses were $71.2 million compared with $71.0 million. Adjusted operating income was $184.1 million compared with $226.0 million for the prior year. Adjusted interest expense was $67.0 million compared with $65.4 million for fiscal 2018. Adjusted net income was $91.8 million, or $2.35 per diluted share, compared with $118.2 million, or $3.10 per diluted share, for the fiscal 2018 full year.

Chris Smith Named Next Chief Executive Officer of Ortho Clinical Diagnostics

On August 27, 2019 Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, reported that its board of directors has appointed Chris Smith as Chief Executive Officer effective September 9, 2019 (Press release, Ortho-Clinical Diagnostics, AUG 27, 2019, View Source [SID1234539027]). Chris will succeed Robert Yates who is stepping down as CEO. Mr. Yates will continue to serve as Ortho’s non-Executive Chairman as a member of the board of directors.

"I am delighted to lead Ortho as its next CEO," said Mr. Smith. "This is an exciting time for the company and I am thrilled to have the opportunity to work with such a talented group of professionals around the world. I look forward to building upon Ortho’s rich history of customer-focused innovation while taking the business to its next chapter of growth as a global diagnostics leader."

"It has been an honor to serve as Ortho’s CEO," said Mr. Yates. "Ortho is strongly positioned for sustainable and predictable growth, with more efficient operations and talented next-generation leaders. I am excited that we were able to recruit Chris who brings the executive leadership, experience and capabilities to continue Ortho’s transformation and value creation."

Stephen Wise, Managing Director and Global Head of Healthcare for The Carlyle Group, which invested in Ortho Clinical Diagnostics in 2014, said, "We are thrilled to welcome Chris as Ortho’s next CEO. Chris brings over 30 years of healthcare sector experience and has a proven track record driving value creation for multinational businesses. We look forward to a long-term partnership with Chris that we believe will create significant value for Ortho."

Mr. Wise continued, "We are grateful to Robert for his significant contribution to Ortho’s success through his strong leadership in recommitting the entire organization to predictable growth and operational efficiencies. His continued guidance as non-Executive Chairman of the board of directors will ensure a seamless transition for Ortho."

In addition to serving as Ortho’s non-Executive Chairman, Mr. Yates will continue to serve as a senior advisor to The Carlyle Group.

Mr. Smith brings a wealth of leadership and operating experience to Ortho. He most recently served as the CEO of Cochlear Limited, a publicly-traded global medical device company headquartered in Australia, from 2015 through 2018. Under his leadership, Cochlear Limited reached annual sales in excess of AU$ 1 billion dollars while the market cap of the company more than doubled to over AU$ 10 billion dollars (US$ 7.5 billion). Mr. Smith also served as the President of Cochlear Americas for more than a decade. Prior to Cochlear, Mr. Smith held several senior executive roles including CEO in Residence for Warburg Pincus and Global Group President of Gyrus Group Plc., a surgical products company.

Mr. Smith currently serves on the board of directors of several companies including Results Physiotherapy, Nyxoah and Akouos, and was a senior external advisor for McKinsey & Co., AngelMD and EQT Partners. He previously served on the board of directors of publicly-listed Xtent Inc. as well as Startek Inc., Universal Biosensors, Gyrus Group Plc, and Acclarent Inc. Mr. Smith holds a Bachelor of Science degree from Texas A&M University.

Pancreatic Cancer Action Network and CDISC Partner to Develop First Therapeutic Area Data Standards for Pancreatic Cancer

On August 27, 2019 The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, reported a collaboration to establish the first-ever data standards specifically for pancreatic cancer (Press release, PanCAN, AUG 27, 2019, View Source [SID1234539026]).

Pancreatic cancer has the lowest survival rate among all major cancers. In nearly every country, pancreatic cancer is the only major cancer with a single-digit five-year survival rate. Every day, more than 1,250 people worldwide will be diagnosed with pancreatic cancer, and an estimated 1,180 will die from the disease. It is estimated that in 2020, 480,000 new cases will be diagnosed globally.

CDISC and PanCAN will develop global, nonproprietary clinical metadata standards that build upon existing CDISC standards to create a Therapeutic Area User Guide (TAUG), which describes how to use CDISC standards to represent data in research studies pertaining to specific diseases. CDISC TAUGs provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

The TAUG is intended to facilitate increased ease of global health data sharing and will include core precision medicine-focused concepts in pancreatic cancer. The suite of CDISC standards – from planning and data collection to organization, analysis and reporting – capture how to structure commonly collected data and outcomes measurements in observational, academic and regulated clinical trials.

The project is being funded through a two-year grant awarded to CDISC by PanCAN.

"Standardizing clinical research data is especially critical with a disease like pancreatic cancer – time is of the essence for patients participating in clinical trials," said PanCAN Chief Data Officer Sudheer Doss, PhD. "With the creation of these new industry-wide standards, which will lead to higher quality data capture, improved efficiencies and cost-savings, data sharing and collaboration within the pancreatic cancer scientific community will be enhanced. This can accelerate clinical advancement and improved patient outcomes. We are pleased to partner with CDISC on this important initiative to benefit patients."

Pancreatic cancer is a devastating disease that is too often diagnosed far too late to respond to currently available treatments," said CDISC President and CEO David R. Bobbitt, MSc, MBA. "CDISC is very pleased to partner with PanCAN to develop the first data standards to drive more meaningful and efficient critical research that will facilitate new treatments. Our work with PanCAN will bring clarity to data."

The TAUG for pancreatic cancer will be freely available via the CDISC website. A machine-readable version designed to facilitate automation in research studies will be available via the CDISC Library API, which all members of the pancreatic cancer research community will be able to access. The anticipated timeline for completion is two years.