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Akorn Names Douglas S. Boothe as President and CEO

Akorn, Inc. (NASDAQ: AKRX), today announced that Douglas S. Boothe has been named president and chief executive officer effective January 1, 2019, bringing deep pharmaceuticals expertise and a proven track record as Akorn looks forward to its next phase as an independent company committed to rebuilding shareholder value.

Boothe is an industry veteran with extensive accomplishments in the specialty, generic and over-the-counter pharmaceuticals business. He brings to Akorn a long history of senior level expertise in general management, strategy, sales and marketing, product selection, supply chain and business development in the US and global arenas.

Highlights among his many skills are the abilities to produce strong revenue growth for specialty and generic products and lead companies through challenging environments with key stakeholders. Boothe has overseen many successful new product development projects, regulatory reviews and approvals, paragraph IV litigations and commercial launches. He has also reinvigorated research and development, regulatory, compliance and supply chain platforms in his past roles.

Most recently, Boothe served as the president of the $600 million generics division of publicly held Impax Laboratories, which developed, manufactured and marketed bioequivalent pharmaceuticals and was acquired by Amneal Pharmaceuticals LLC in a reverse merger transaction in May 2018.

Prior to that Boothe was the executive vice president and general manager of Perrigo Company Plc, with responsibility for the approximately $1 billion U.S. pharmaceuticals business, which included generics and specialty pharmaceutical products. He also served as the CEO of Actavis Inc., the U.S. manufacturing and marketing division of Actavis Group, and held senior positions at Alpharma and Pharmacia Corp.

“My fellow board members and I are truly excited to welcome Doug to Akorn at this pivotal time for the company,” said Board of Directors Chairman Alan Weinstein. “After a comprehensive search, Doug quickly rose to the top of the list due to his proven track record in helping build businesses, navigate regulatory complexities and guide companies through competitive market environments.”

Boothe said: “I am excited and humbled with the opportunity to lead Akorn and our dedicated employees as we focus our energies toward expanding our offerings to customers, improving our financial performance and enhancing long-term shareholder value. Akorn and I are committed to manufacturing excellence and quality as we move forward.”

Boothe received his undergraduate degree from Princeton University and his MBA from the Wharton School of Business at the University of Pennsylvania.

=> na dann, frohes Gelingen
Antwort auf Beitrag Nr.: 59.492.781 von faultcode am 21.12.18 20:08:39
Akorn receives 'warning letter' from FDA related to a manufacturing facility

...Akorn Inc. said Wednesday that it received a warning letter from the Food and Drug Administration, related to an inspection of the generic drug maker's Decatur, Illinois manufacturing facility.

The stock was halted for news, and was inactive prior to the halt. The FDA had investigated the facility in April and May 2018. The company said it will respond to the FDA letter, dated Jan. 4, within 15 working days.

"Akorn is committed to the highest standards of quality and compliance, and will continue to work collaboratively with the FDA to resolve all issues addressed in the warning letter," Akorn said in a statement...
Antwort auf Beitrag Nr.: 59.592.743 von faultcode am 09.01.19 14:03:25Au - Fresenius hat nachgelegt ("amendment"):

Akorn Comments on Fresenius’ Proposed Amended Claims

...Akorn, Inc. (Nasdaq: AKRX) today announced that it strongly contests Fresenius’ proposed amended claims filed earlier today.

Akorn believes these claims are meritless and overreaching. Akorn denies the allegations and will vigorously defend itself in this litigation, while continuing to focus on advancing its pipeline, strengthening its business and developing a strategic plan for improving financial performance and long-term shareholder value....

=> -9% gestern
Antwort auf Beitrag Nr.: 59.931.692 von faultcode am 21.02.19 13:43:3628.2.

Fourth Quarter 2018 and Recent Business Highlights

Net revenue was $153 million, a decline of $33 million, or 17.6%, compared to the fourth quarter of 2017, predominantly due to the effect of competition on key products and shortfalls in supply

• Net loss was $215 million compared to a net loss of $65 million in the fourth quarter of 2017. Adjusted EBITDA was $(20) million compared to $28 million in the fourth quarter of 2017

• Continued progress on completion of FDA action items related to the inspections of our facilities in Decatur and Somerset

• Appointed Douglas Boothe as President and Chief Executive Officer, bringing significant generic and specialty pharmaceutical leadership experience

• Announced new additions to Board of Directors and Executive Management team adding significant expertise to the Company’s leadership

• Focused on moving forward and rebuilding shareholder value as an independent company following the terminated Fresenius Kabi AG merger agreement

• Engaged financial, operational, and legal advisors to help develop and execute long-term growth plan

• Healthy cash position of $225 million as of December 31, 2018
Antwort auf Beitrag Nr.: 59.989.915 von faultcode am 28.02.19 20:24:27
Akorn Comments on Favorable Court Order
http://investors.akorn.com/news-releases/news-release-detail…" target="_blank" rel="nofollow">http://investors.akorn.com/news-releases/news-release-detail…

=> LAKE FOREST, Ill., March 01, 2019 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq: AKRX) announced today that the Delaware Court of Chancery has denied a request by Fresenius Kabi AG to bring a fraud claim against Akorn. ...
Akorn Provides Preliminary First Quarter 2019 Results and Full Year Guidance => +18% premarket

First Quarter 2019 and Recent Business Highlights

• Net revenue was $166 million, up 8% from the fourth quarter of 2018, down 10% from the prior year quarter

• Net loss was $82 million, compared to $215 million in the fourth quarter of 2018 and $29 million in the prior year quarter

• Adjusted EBITDA was $10 million, compared to ($20) million in the fourth quarter of 2018 and $25 million in the prior year quarter

Cash position of $184 million as of March 31, 2019

Full year 2019 guidance anticipates continued sequential improvement throughout the year

• Ongoing progress towards completion of FDA action items related to the inspections of our facilities in Decatur and Somerset

• Further strengthening of leadership team and organizational capabilities

• Significant reduction in backorders and failure to supply penalties

• Two products launched year-to-date: Ropivacaine Hydrochloride Injection, USP (2mg/ml) and TheraTears® SteriLid® Antimicrobial, the 1st FDA Accepted Antimicrobial Eyelid Cleanser

• Two New Product Approvals: Loteprednol Etabonate Ophthalmic Suspension, 0.5% and Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC)

• Extended revolving credit facility and executed a Standstill Agreement with current lending institutions

See "Non-GAAP Financial Measures" below.
Antwort auf Beitrag Nr.: 60.505.692 von faultcode am 07.05.19 14:01:17..und nun +27%
AH +3&

May 20, 2019 4:05 PM EDT
Akorn Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.1%

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