Fresenius has decided today to terminate the company’s merger agreement with Akorn, due to Akorn’s failure to fulfill several closing conditions.
Fresenius’ decision is based on, among other factors, material breaches of FDA1 data integrity requirements relating to Akorn’s operations found during Fresenius’ independent investigation. Fresenius offered to delay its decision in order to allow Akorn additional opportunity to complete its own investigation and present any information it wished Fresenius to consider, but Akorn has declined that offer.
Fresenius confirms its guidance for 2018. The Group continues to expect a sales growth of 5% to 8%2 in constant currency. Group net income3 is expected to increase by 6% to 9%4 in constant currency (excluding expenditures for the further development of the biosimilars business around 10% to 13%5).
On Saturday, Fresenius Medical Care announced the sale of Sound Inpatient Physicians Holdings, LLC. The expected pre-tax book gain of around €800 million on this transaction is excluded from Fresenius’ 2018 Group guidance.
Fresenius will report its first-quarter results, as scheduled, on May 3, 2018.
1FDA: Food and Drug Administration
22017 adjusted for IFRS 15 (EUR486 million at Fresenius Medical Care)
3Net income attributable to shareholders of Fresenius SE & Co. KGaA
4Base 2017: EUR1,816 million; 2018 before special items (acquisition-related expenses); including expenditures for further development of biosimilars business (EUR43 million after tax in FY/17 and ~EUR120 million after tax in FY/18)
5Base 2017: EUR1,859 million; 2018 before special items (acquisition-related expenses); excluding expenditures for further development of biosimilars business (EUR43 million after tax in FY/17 and ~EUR120 million after tax in FY/18)
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Kabi has started work on a major expansion of its production site for medical devices in Haina, Dominican Republic, which will create about 500 new jobs. At a groundbreaking ceremony yesterday attended by the country’s President Danilo Medina, the cornerstone was laid for the approximately 7,400-square-meter (80,000-square-foot) expansion. It will significantly increase capacity in Haina through the addition of new plasma kit assembly lines, injection molding equipment, sterilization units and dedicated warehouse space.
Completion of the expansion is scheduled for late 2019. The new employees, including production workers, technical personnel, engineers and managers, will join a Fresenius Kabi workforce in Haina that currently numbers about 3,000. The total investment is more than €20 million ($25 million).
The Haina plant manufactures and exports apheresis systems for plasma and platelet collection as well as medical devices for blood separation. These products are used, for example, to allow blood components to be separated while the blood is being donated, making it possible for these life-saving donations to be used more quickly and efficiently.
Mats Henriksson, CEO of Fresenius Kabi, said the products manufactured by the company in the Dominican Republic are important in the provision of healthcare far beyond the country. “Our employees here in Haina do an excellent job, and will continue to produce high-quality medical devices that provide healthcare professionals with the equipment they need to help their patients,” Henriksson said.
Also on hand for the ceremony was Dr. Christian Hauer, President Medical Devices Division of Fresenius Kabi. “This expansion will enable us to reach new potential in regard to our production capacities,” Hauer said. “Our strong commitment to our production site in Haina will benefit even more patients, and allow us to play an even greater role in improving the lives of chronically and critically ill people around the world.”
Caption for press photo:
Front row from left to right: Bernardo Alvarez, General Plant Manager Haina, Christian Hauer, Board Member of Fresenius Kabi and President of the Medical Devices Division, Mats Henriksson, CEO of Fresenius Kabi, Danilo Medina, President of the Dominican Republic, Manuel Tavares, CEO PIISA Industrial Park, Luisa Fernandez, Free Zone Council Director, Nelson Toca, Minister of Commerce and Industry of the Dominican Republic, Ramon Fadul, Labor Minister of the Dominican Republic, Tommy Galan, Senator of San Cristobal Province
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Melphalan Hydrochloride for Injection is the newest addition to the company’s oncology portfolio.
Palonosetron Hydrochloride Injection is the newest addition to the company’s expanding portfolio of IV drugs. It is an antiemetic that can be used for chemotherapy-induced nausea and vomiting.
Remifentanil is the newest addition to the company’s extensive portfolio of anesthesia and analgesia products. Remifentanil is a controlled substance sold only to licensed health care professionals for patient care and is distributed under strict controls in compliance with FDA and DEA regulations.
Bortezomib for intravenous use is the first and only available alternative to Bortezomib for Injection and is the newest addition to the company’s expanding oncology portfolio.
Fresenius Kabi has submitted a Marketing Authorization Application to the European Medicines Agency for its adalimumab biosimilar candidate of Humira®. The application is the first biosimilar regulatory filing for Fresenius Kabi. Adalimumab is approved in the EU for use in the treatment of chronic inflammatory autoimmune conditions, including different types of arthritis or Crohn's disease.
Fresenius Kabi has submitted a Marketing Authorization Application to the European Medicines Agency for its adalimumab biosimilar candidate of Humira®. The application is the first biosimilar regulatory filing for Fresenius Kabi. Adalimumab is approved in the EU for use in the treatment of chronic inflammatory autoimmune conditions, including different types of arthritis or Crohn's disease.
Fresenius Kabi opened the extension of its production plant in Mihla, Germany, today with a festive dedication ceremony attended by Mayor Rainer Laemmerhirt. The healthcare company invested about €10 million in the project.
In the new production hall, employees will make core injection-molded components for pharmaceutical containers, port systems – which enable infusions to be administered as gently as possible, for example during chemotherapy – and medical disposables. The latter include such products as feeding tubes and giving sets, which are routinely used in hospitals to administer infusion therapies, clinical nutrition and intravenous drugs. The extension will enable Fresenius Kabi to produce components it previously had to purchase from suppliers.
At approximately 1,000 square meters (10,700 square feet), the new hall doubles the amount of space available for production activities at the plant in Mihla, a town in the eastern German state of Thuringia. The project also includes an expansion of the plant’s warehouse to hold as many as 2,000 pallets – a more than six-fold increase.
Dr. Christian Hauer, President Medical Devices Division of Fresenius Kabi, said: “Products from Fresenius Kabi are used in the care of chronically and critically ill patients, which makes the highest standards of quality and reliability essential. Our employees in Mihla have been doing outstanding work for many years. I’m delighted that with this extension, we are making our Mihla production location ready for the future.”
Mayor Laemmerhirt praised Fresenius Kabi for its commitment to his community: “I am very happy that Fresenius Kabi, as a globally active company, is investing here in Mihla. This can also be seen as a positive sign for our region and its economic development.”
Fresenius Kabi is expanding its activities in Indonesia. PT ETHICA Industri Farmasi, a joint venture of Fresenius Kabi and the Indonesian pharmaceuticals company SOHO Global Health, opened a new plant in Cikarang, just outside the country’s capital and biggest city Jakarta. The plant’s approximately 230 employees will produce a wide range of injectable drugs needed in therapeutic areas including gynecology, anesthesia and intensive care. The products are planned for use by Indonesian patients and for export to other Southeast Asian countries. Fresenius Kabi employs a total of about 530 people in Indonesia.