Quest Diagnostics Reports First Quarter 2020 Financial Results

On April 22, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the first quarter ended March 31, 2020 (Press release, Quest Diagnostics, APR 22, 2020, View Source [SID1234556495]).

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"We were very pleased with Quest’s results in January and February, which were consistent with the full-year guidance we provided in January," said Steve Rusckowski, Chairman, CEO and President. "However, in March, we experienced a material decline in testing volumes due to the COVID-19 pandemic. During the last two weeks of March, volumes declined in excess of 40%, including COVID-19 testing."

Mr. Rusckowski continued: "We are managing the company for the long term and have taken a series of actions to protect our financial flexibility. These include pay cuts for me, the board, and my team; suspension of certain benefits, such as our 401(k) match; reduced hours for employees whose work has significantly declined; and approved furloughs for employees with diminished work who expressed interest. The temporary actions we are taking, combined with our cash position and access to additional capital, put us in a strong financial position to operate in a range of scenarios as we navigate the COVID-19 crisis.

"I am proud that the Quest team has stepped up to bring crucial COVID-19 testing capacity to the nation during this crisis. To date, we have performed approximately one million molecular tests and have begun to perform blood-based antibody testing. We believe antibody testing will become a critical tool to understand who has been exposed to the virus and who may have immunity. Quest has been at the tip of the spear in responding to this crisis, and we continue to play a critical role in the next phase of containing COVID-19.

"While there is uncertainty in the near term, we look forward to gradually improving conditions. Eventually, the healthcare system will start to return to normal. When that happens, Quest will emerge from the crisis stronger with significant opportunities in front of us."

(a) 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.

Financial Position

As of March 31, 2020, Quest Diagnostics had cash on hand of $342 million and had $1.3 billion of borrowing capacity available under existing credit facilities, including $529 million available under a secured receivables credit facility and $750 million available under a senior unsecured revolving credit facility. There were no outstanding borrowings under these facilities as of March 31st. In April, the Company borrowed $100 million under the secured receivables credit facility and $100 million under the senior unsecured revolving credit facility.

The Company’s secured receivables facility is subject to certain financial covenants with respect to the receivables that comprise the borrowing base and secure the borrowings under the facility. The unsecured revolving credit facility is also subject to certain financial covenants and limitations on indebtedness. In particular, the unsecured revolving credit facility requires the Company to maintain a leverage ratio of no more than 3.5 times EBITDA as of the last day of each fiscal quarter. As of March 31, 2020, the Company was in compliance with all applicable financial covenants.

The COVID-19 pandemic is likely to impact the Company’s ability to comply with applicable financial covenants, beginning as early as the end of the second quarter. In this scenario, the Company would not be able to borrow against these credit facilities and the lenders would have the right to demand payment of any amounts outstanding. The Company has been in advanced discussions with its lead lender regarding an amendment to certain financial covenants of its unsecured revolving credit facility. The Company believes this would provide it with the necessary flexibility to remain in compliance for the remainder of 2020. The Company is confident that it will be able to enter into this amendment later in the quarter. The Company also believes that its investment grade credit rating would provide it with access to alternate sources of financing should they become necessary.

Share repurchase program and quarterly dividend

For the three months ended March 31, 2020, the company repurchased 0.7 million shares of its common stock for $75 million but has suspended additional share repurchases through the end of the year under its existing authorization.

The company’s Board of Directors remains committed to its quarterly dividend at this time.

Outlook for full year 2020 withdrawn

On March 31, 2020, Quest Diagnostics filed a Current Report on Form 8-K with the Securities and Exchange Commission to outline the impact of the COVID-19 pandemic on its operating results, cash flows and financial condition and withdraw its previously announced guidance for full year 2020. The company is unable to accurately forecast the near term impact of the pandemic on its business given the rapidly evolving uncertainties and likely outcomes but intends to provide an updated outlook at an appropriate time.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under 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 benefits ("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 non-GAAP 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: 7895081; 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 800-839-1170 for domestic callers or 402-998-0559 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 22, 2020 until midnight Eastern Time on May 6, 2020. 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.

Ligand’s First Quarter Financial Results to be Reported May 6th

On April 22, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that details of its plans to report first quarter 2020 financial results on May 6, 2020 (Press release, Ligand, APR 22, 2020, View Source [SID1234556493]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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What:

Ligand conference call to discuss financial results and provide general business updates

Date:

Wednesday, May 6, 2020

Time:

4:30 p.m. Eastern time (1:30 p.m. Pacific time)

Conference Call:

Dial (833) 325-0071 within the U.S.

Dial (720) 405-1612 outside the U.S.

Conference ID is 5190682

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

BioCryst to Report First Quarter 2020 Financial Results on May 6

On April 22, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its first quarter 2020 financial results on Wednesday, May 6, 2020 (Press release, BioCryst Pharmaceuticals, APR 22, 2020, View Source [SID1234556492]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4679821. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4679821.

Chi-Med Highlights Presentations of Surufatinib at the Upcoming AACR Virtual Annual Meetings

On April 22, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that new and updated analyses on the ongoing studies of surufatinib will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place on April 27, 2020 (Press release, Hutchison China MediTech, APR 22, 2020, https://www.chi-med.com/surufatinib-presentations-at-aacr-2020/ [SID1234556491]).

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Further details of the presentations are as follows:

Title: A Phase I Trial of Surufatinib Plus Toripalimab in Patients with Advanced Solid Tumors
Presenter: Yanshuo Cao
Authors:
M Lu1, Y Cao1, J Gong1, Y Sun2, J Li1, L Shen1.

1 Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China; 2 Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China

Session: VPO.CT01
Number: CT142
Link: www.abstractsonline.com/pp8/#!/9045/presentation/10641

Title: Comparison of Pharmacokinetic Profiles and Safety of Surufatinib in Patients from China and the United States
Presenter: Arvind Dasari
Authors:
A Dasari1, S Paulson2, E Hamilton3, J Wang4, M Sung5, G Falchook6, C Tucci7, K Li7, C Chien7, J Kauh7, M Kania7, D Li8.

1 MD Anderson Cancer Center, Houston, TX, USA, 2 Baylor Sammons Cancer Center, Dallas, TX, MD Anderson Cancer Center, Houston, TX, USA, 3 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA, 4 Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA, 5 Mount Sinai Hospital, New York, NY, USA, 6 Sarah Cannon Research Institute at HealthONE, Denver, Co, USA, 7 Hutchison MediPharma International Inc., Florham Park, NJ, USA, 8 City of Hope Cancer Center, Duarte, CA, USA.

Session: VPO.CT01
Number: CT115
Link: www.abstractsonline.com/pp8/#!/9045/presentation/10614

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.

Chi-Med currently retains all rights to surufatinib worldwide.

Neuroendocrine tumors ("NET") in the U.S., Europe and Japan: We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration, based on the encouraging data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019.

Non-pancreatic neuroendocrine tumors in China: In November 2019, a New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the Independent Data Monitoring Committee ("IDMC") to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress (clinicaltrials.gov identifier: NCT02588170).

Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission, following an interim analysis review conducted in January 2020 by the IDMC that recommended that registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821). Study results will be submitted for presentation at an upcoming scientific conference.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt, approved in China by Innovent Biologics, Inc.

Achilles Therapeutics to present a manufacturing update at the virtual 2020 AACR Annual Meeting

On April 22, 2020 Achilles Therapeutics ("Achilles"), a clinical-stage oncology company developing personalised cell therapies targeting clonal neoantigens, a novel class of tumour target, reported that it will present a manufacturing update using the VELOSTM manufacturing platform for its lead programs at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (Press release, Achilles Therapeutics, APR 22, 2020, View Source [SID1234556490]).

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"This study using our VELOSTM manufacturing platform demonstrates the feasibility of generating clonal neoantigen T cells, or cNeT, for the treatment of NSCLC and recurrent or metastatic melanoma," said Ed Samuel, SVP Manufacturing, Achilles Therapeutics. "Achilles is at a transformational stage in its development as we progress our two lead products into the clinic. We have prioritised our scaled GMP manufacturing platform from the inception of the Company in order to support our long-term strategy to develop a fully closed and automated manufacturing process which is central to our plans for scaling up production capabilities to deliver personalized cell therapies to patients."

Oral Presentation details:

The virtual meeting is free and available to anyone by registering at aacr.org.

Presentation Title:

The development of a personalised autologous clonal neoantigen T cell therapy for the treatment of solid cancer using the VELOSTM manufacturing platform generates highly potent and reactive CD8+ and CD4+ T cells for clinical use
Presenter: Ed Samuel
Session Title: VCTPL05 – Adoptive Cell Transfer Therapy
Date and Presentation Time: April 28, 2020 – 11:55 – 12:05 PM EDT
Abstract Number: CT054