Quest Diagnostics Reports First Quarter 2019 Financial Results

On April 23, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the first quarter ended March 31, 2019 (Press release, Quest Diagnostics, APR 23, 2019, View Source [SID1234535341]).

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"We’re off to a good start in 2019, with solid volume growth from our expanded health plan access," said Steve Rusckowski, Chairman, President and CEO. "As we anticipated, volume accelerated through the quarter, and we look forward to continued progress as a member of UnitedHealthcare’s Preferred Lab Network beginning July 1. We continue to drive productivity to address ongoing reimbursement pressure, and are well positioned to meet our financial commitments for the remainder of 2019."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Beginning in 2019, the company has changed how it presents adjusted income measures to additionally exclude amortization expense for all periods. We believe this presentation provides investors with additional insight to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business.

Outlook for full-year 2019

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefit ("ETB") associated with stock-based compensation, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: Investor; or via live webcast on the Company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-480-3547 for domestic callers or 203-369-1551 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 23, 2019 until midnight Eastern Time on May 7, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

ExCellThera’s lead technology, ECT-001, receives FDA Regenerative Medicine Advanced Therapy (RMAT) designation

On April 23, 2019 ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies (Press release, ExCellThera, APR 23, 2019, View Source [SID1234535340]). The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers.

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RMAT designation is granted by the FDA under the 21st Century Cures Act for cell therapies, tissue-engineered or similar products intended to treat or cure a serious disease, and which demonstrate preliminary evidence to address an unmet clinical need. It accords all the benefits of the FDA’s fast track and breakthrough therapy designation programs, including an ability to interact with the agency to discuss the potential acceleration of regulatory approval. Under the auspices of the RMAT designation, FDA will work closely with ExCellThera and provide advice on generating the evidence needed to support approval of ECT-001 in an efficient manner.

"The FDA’s RMAT designation is a clear signal of confidence in the potential of our lead cell therapy drug product, ECT-001, to treat patients with hematologic malignancies," said Dr. Guy Sauvageau, CEO and founder of ExCellThera. "We look forward to working with the FDA within the RMAT framework to advance ECT-001 through the final phases of clinical development in an expedited manner."

Various clinical studies using ECT-001 are currently ongoing in the treatment of multiple myeloma, high-risk leukemia and other hematologic malignancies. In addition, ExCellThera plans to initiate additional clinical trials, including a pivotal trial in the United States and Canada, in the coming months. ECT-001 has also received FDA orphan drug designation for the prevention of graft-versus-host disease.

About ECT-001
The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative cord blood transplant therapies for patients with blood cancers, allowing rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.

Halozyme To Host First Quarter 2019 Financial Results Webcast And Conference Call

On April 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the first quarter 2019 on Tuesday, May 7 at 4:30 p.m. ET / 1:30 p.m. PT (Press release, Halozyme, APR 23, 2019, View Source [SID1234535337]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the first quarter ended March 31, 2019 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (866) 393-4306 (domestic callers) or (734) 385-2616 (international callers). A telephone replay will be available after the call by dialing (855) 859-2056 (domestic callers) or (404) 537-3406 (international callers) using replay ID number 3076769.

Jazz Pharmaceuticals to Report 2019 First Quarter Financial Results on May 7, 2019

On April 23, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2019 first quarter financial results on Tuesday, May 7, 2019, after the close of the financial markets (Press release, Jazz Pharmaceuticals, APR 23, 2019, View Source [SID1234535336]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EDT/9:30 p.m. IST to discuss first quarter 2019 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 6667859

A replay of the conference call will be available through May 14, 2019 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 6667859

Zimmer Biomet to Present at Bank of America Merrill Lynch Healthcare Conference

On April 23, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that it will participate in the Bank of America Merrill Lynch Healthcare Conference at the Encore Hotel in Las Vegas, Nevada (Press release, Zimmer Holdings, APR 23, 2019, View Source [SID1234535335]). Daniel P. Florin, Executive Vice President and Chief Financial Officer and Cole Lannum, CFA, Senior Vice President of Investor Relations, will present for the company on Thursday, May 16, 2019 at 8:00 a.m. Pacific Time.

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A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. The webcast will be archived for replay following the conference.