DaVita Inc. 3rd Quarter 2019 Results

On November 5, 2019 DaVita Inc. (NYSE: DVA) reported results for the quarter ended September 30, 2019 (Press release, DaVita, NOV 5, 2019, View Source [SID1234550497]).

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Third quarter 2019 financial and operational highlights:

Consolidated revenues of $2.904 billion.
Operating income of $378 million and adjusted operating income of $462 million.
Cash flows from continuing operations of $648 million.
Entered into a new $5.5 billion senior secured credit agreement and redeemed our 5.75% senior notes.
Repurchased 30,591,750 shares of our common stock at an average cost of $57.14 per share.

For the definitions of non-GAAP financial measures see the note titled "Note on Non-GAAP Financial Measures" and related reconciliations beginning at page 14.

Certain items impacting the quarter:

Debt transactions: On August 12, 2019, we entered into a new $5.5 billion senior secured credit agreement consisting of a $1.75 billion senior secured Term Loan A facility with a delayed draw feature, a $2.75 billion senior secured Term Loan B facility and a $1.0 billion senior secured revolving line of credit. As of September 30, 2019, the new Term Loan A and Term Loan B were fully drawn and the new revolving line of credit remained undrawn. We used the proceeds from the new senior secured credit facilities to pay off the remaining balances outstanding on our previous senior secured credit facilities, redeem our 5.75% senior notes due 2022 and pay related redemption fees, and fund our modified "Dutch auction" tender offer (Tender Offer) to purchase shares of our common stock as further described below, as well as to repurchase additional shares of our common stock through open market transactions. The remaining debt borrowings added cash to our balance sheet for potential acquisitions, share repurchases and other general corporate purposes.

As a result of the debt transactions described above, we recorded debt refinancing and redemption charges of $21 million in the third quarter of 2019. These charges consist of write-offs of old debt discount and deferred financing costs, as well as the redemption premium associated with our 5.75% senior notes and professional fees.

Share repurchases: The following table summarizes repurchases of our common stock during the three and nine months ended September 30, 2019.

The amount paid for shares repurchased associated with the Company’s Tender Offer during the three and nine months ended September 30, 2019 includes the clearing price of $56.50 per share plus related fees and expenses of $2 million.

In addition to the share repurchases described above, we have also repurchased 4,283,376 shares of our common stock for $246 million at an average cost of $57.32 per share from October 1, 2019 through November 4, 2019. Effective November 4, 2019, our Board of Directors terminated all remaining prior share repurchase authorizations available to us and approved a new share repurchase authorization of $2 billion.

Non-GAAP adjustments to operating income:

Goodwill impairment charge: During the quarter ended September 30, 2019, we recognized a non-cash goodwill impairment charge of $79 million in our Germany kidney care business as a result of continuing developments in the business and our expected timing and ability to mitigate them. This charge included a $17 million increase to the goodwill impairment charge due to the deferred tax assets that the impairment itself generated. The result was a $79 million goodwill impairment charge to operating income, a $17 million credit to tax expense, and a net $62 million impact on net income. We also recognized a $5 million goodwill impairment charge in our other German health operations.

For the definitions of non-GAAP financial measures see the note titled "Note on Non-GAAP Financial Measures" and related reconciliations beginning at page 14.

Volume: Total U.S. dialysis treatments for the third quarter of 2019 were 7,673,191, or an average of 97,129 treatments per day, representing a per day increase of 2.7% over the third quarter of 2018. Normalized non-acquired treatment growth in the third quarter of 2019 as compared to the third quarter of 2018 was 2.2%.

Effective income tax rate: Our effective income tax rate on income from continuing operations was 23.8% and 24.3% for the three and nine months ended September 30, 2019, respectively. This effective income tax rate was impacted by the amount of third party owners’ income attributable to non-tax paying entities. The effective income tax rate on income from continuing operations attributable to DaVita Inc. was 30.3% and 29.8% for the three and nine months ended September 30, 2019, respectively.

Our effective income tax rate on income from continuing operations attributable to DaVita Inc. for the three and nine months ended September 30, 2019 was further impacted by the write-off of deferred financing costs, other debt costs and goodwill impairment charges. Excluding these items from the three and nine months ended September 30, 2019, our effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. would have been 27.6% and 28.4% for the three and nine months ended September 30, 2019, respectively.

Center activity: As of September 30, 2019, we provided dialysis services to a total of approximately 233,300 patients at 2,985 outpatient dialysis centers, of which 2,736 centers were located in the United States and 249 centers were located in nine countries outside of the United States. During the third quarter of 2019, we opened a total of 24 new dialysis centers, acquired two dialysis centers and closed 13 dialysis centers in the United States. In addition, we opened one new dialysis center, acquired two dialysis centers and closed two dialysis centers outside of the United States during the third quarter of 2019.

Outlook:

The following forward-looking measures and the underlying assumptions involve significant risks and uncertainties, including those described below, and actual results may vary significantly from these current forward-looking measures. We do not provide guidance for consolidated operating income, diluted net income from continuing operations per share attributable to DaVita Inc. or effective tax rate on income from continuing operations on a GAAP basis nor a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures on a forward-looking basis because we are unable to predict certain items contained in the GAAP measures without unreasonable efforts. These non-GAAP financial measures do not include certain items, including goodwill impairment charges and foreign currency fluctuations, any of which may be significant. The guidance for effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. also excludes the write-off of deferred financing costs, other debt costs and the amount of third party owners’ income and related taxes attributable to non-tax paying entities.

We will be holding a conference call to discuss our results for the third quarter ended September 30, 2019, on November 5, 2019, at 5:00 p.m. Eastern Time. To join the conference call, please dial (877) 918-6630 from the U.S. or (517) 308-9042 from outside the U.S., and provide the operator the password ‘Earnings’. A replay of the conference call will be available on our website at investors.davita.com for the following 30 days.

Montefiore Medicine Names Philip O. Ozuah, MD, PhD, As CEO

On November 5, 2019 Montefiore Medicine’s Board of Trustees reported that Dr. Philip O. Ozuah has been named the next Chief Executive Officer of Montefiore Medicine, the umbrella organization for Montefiore Health System (MHS) and Albert Einstein College of Medicine (Press release, Montefiore Medical Center, NOV 5, 2019, View Source [SID1234550495]). As CEO, Dr. Ozuah will lead Montefiore Medicine’s next phase of growth and evolution as a global healthcare leader, renowned for its leading medical school, groundbreaking research and technology, and highly specialized, coordinated care of diverse populations in the New York region, across the country and globally. Dr. Ozuah will begin as Chief Executive Officer on November 15, 2019.

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"We are thrilled Dr. Philip Ozuah, a proven senior executive and strong strategic thinker, will lead Montefiore into the next decade," said Dan Tishman, Chair of the Board of Trustees of Montefiore Medicine. "What stood out was his impressive record of success at MHS, his intellect and warmth as a physician, his strength as a leader and manager and his deep commitment to Montefiore’s mission. I’d also like to thank our outgoing CEO, Dr. Steven Safyer, for his 40 years of service that put our organization on a path of excellence."

"It will be a privilege to lead Montefiore Medicine, an organization with a clear purpose – to heal, to teach, to discover and to advance the health of the communities we serve," said Dr. Ozuah. "Ever since first joining Montefiore in 1989, I’ve been inspired by our institution’s commitment to excellence. We are an organization of exceptionally talented and compassionate people. Working closely with the Board, I look forward to continuing to expand inclusive access to state-of-the-art care and to furthering Montefiore’s role as a global leader in healthcare and biomedical research."

Outgoing CEO Dr. Steven Safyer commented: "It has been a privilege to serve the Montefiore community over the past four decades and, having worked alongside Dr. Ozuah for the past 25 years, I know I am leaving our institution in the best possible hands. I have consistently been impressed by Dr. Ozuah’s strategic vision for the Montefiore Health System. His appointment as CEO will guarantee a smooth transition, and I know he’ll continue to uphold the standard of excellence on which Montefiore has built its reputation."

Dr. Ozuah currently serves as President of Montefiore Health System and previously served as Physician-in-Chief of the Children’s Hospital at Montefiore (CHAM), where he worked to deliver best-in-class clinical care with a commitment to healthcare access for the underserved. Under his leadership, U.S. News and World Report has ranked Montefiore Health System’s medical specialties in the top 1% of the nation’s hospitals and Children’s Hospital at Montefiore (CHAM) as one of "America’s Best Children’s Hospitals." Dr. Ozuah also has a strong commitment to medical education as well as deep academic medical research expertise, including as an NIH-funded investigator and as Professor and University Chairman of Pediatrics at the Albert Einstein College of Medicine.

In these roles, Dr. Ozuah expanded access for underserved communities, recruited and cultivated outstanding talent, advanced programs of excellence, fostered innovations in medical education, and improved financial and operational performance by integrating care across a rapidly growing and evolving Montefiore system that sees over six million patient interactions a year. He’s been recognized regionally and nationally for excellence in teaching and patient care, including as an inductee into the Alpha Omega Alpha Honor Medical Society and a two-time recipient of the Academic Pediatric Association’s prestigious Helfer Award for Innovation in Medical Education. Along with his various awards for teaching and clinical excellence, Dr. Ozuah has also been recognized by Modern Healthcare as one of the "Top 25 COOs in Healthcare."

Dr. Ozuah earned his medical degree from the University of Ibadan, Nigeria, a Master’s Degree in Education from the University of Southern California, Los Angeles, and a PhD in Educational Leadership and Administration from the University of Nebraska, Lincoln. He completed his Pediatric Internship and Residency at the Albert Einstein College of Medicine and Montefiore, and his Post-Doctoral Fellowship in Medical Education at the University of Southern California School of Medicine, Los Angeles.

Dr. Ozuah’s appointment follows a succession planning process conducted by the Board, who were advised by leadership consulting firm Spencer Stuart.

Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)

On November 5, 2019 Sandoz, a Novartis division and a global leader in biosimilars, reported that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez) (Press release, Sandoz, NOV 5, 2019, View Source [SID1234550446]). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.

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Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

"When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy," said Carol Lynch, President of Sandoz Inc. "The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services."

A study has shown that each year in the US, more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result.1 Sandoz is now the first and only company to offer physicians in the US the choice between a long- and short-acting biosimilar filgrastim treatment to best suit the individual needs of tens of thousands of patients undergoing chemotherapy.

The FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104).2 This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.

Sandoz has proven biosimilars create early and expanded patient access to life-changing biologics while increasing healthcare savings. Its four approved biosimilars in the US are part of a leading global portfolio with eight marketed biosimilars. Building on this success, Ziextenzo can help increase positive treatment outcomes for patients undergoing chemotherapy and drive significant savings for the healthcare system.2,3

Sandoz is a global biosimilar leader and will continue to help millions of patients in oncology, immunology, endocrinology and other underserved therapy areas access biologic medicines sustainably and affordably.

About Ziextenzo (pegfilgrastim-bmez)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person’s own body. Ziextenzo is indicated in the US to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.4 Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.5

Cumberland Pharmaceuticals To Announce Third Quarter 2019 Financial Results

On November 5, 2019 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release third quarter 2019 financial results after the market closes on Tuesday, November 12, 2019 (Press release, Cumberland Pharmaceuticals, NOV 5, 2019, View Source [SID1234550387]). A conference call and live Internet webcast will be held on Tuesday, November 12, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9865969. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Ryvu Therapeutics to Present at BIO-Europe 2019

On November 5, 2019 Ryvu Therapeutics (WSE: RVU) reported that Pawel Przewiezlikowski, Chief Executive Officer, will present a corporate overview at the following conference in Hamburg, Germany (Press release, Ryvu Therapeutics, NOV 5, 2019, View Source [SID1234550386]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Event: BIO-Europe 2019, Nov. 11-13, 2019
Location: Congress Center Hamburg
Date/Time: Tuesday, Nov. 12, at 4:15 p.m. CET