On April 7, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported certain unaudited preliminary first quarter financial results (Press release, Integra LifeSciences, APR 7, 2020, View Source [SID1234556168]). The company also announced that it will release full first quarter 2020 financial results on Thursday, May 7, 2020, prior to market open. Given the existing uncertainty related to COVID-19, the company is withdrawing its guidance for the first quarter and full-year 2020 previously issued on February 19, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Preliminary First Quarter Revenue Results and Second Quarter Outlook

First quarter 2020 reported revenue is expected to be in the range of $352 million to $354 million, representing a decline of approximately -1.9% on a reported basis and approximately -0.5% on an organic basis compared to the first quarter of 2019. While the first two months of the quarter were in line with management expectations, surgical procedures declined significantly in March as healthcare providers reallocated resources to address the increasing demands caused by COVID-19. The preliminary results set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

The Company expects the ongoing impact from restrictions on surgical procedures and shelter-in-place policies to have a more substantial negative impact on second quarter performance. Though we currently are unable to determine the magnitude of the impact, we are continuing to monitor, assess and respond to the situation, and we will provide an update on May 7, 2020.

Response to COVID-19 (Coronavirus)

Integra’s primary focus during this global crisis remains on supporting patients, providing customers with life-saving products, and protecting the well-being of its employees.

In February, the Company implemented contingency plans to address the operational impact of COVID-19 and ensure ongoing operations, focusing primarily on the Asia Pacific region. During March, the rapid and evolving spread of the virus resulted in an unprecedented challenge to the global healthcare industry. In response to the challenge, the Company has expanded its contingency plans to enable its manufacturing and distribution sites around the world to continue operating at levels required to meet demand and to provide for the safety of its employees. In addition, the Company has initiated significant cost-savings measures. Those measures include freezing hiring, eliminating overtime, ending third-party services and temporary contractor relationships, and rapidly reducing capital expenditures and discretionary spending including travel, events, and marketing programs. The Company will provide more details on these cost-savings measures on May 7, 2020. Given the ongoing uncertainty to revenues and operating costs surrounding COVID-19, the first quarter 2020 and the full-year 2020 financial guidance provided by the Company on February 19, 2020 should no longer be relied upon.

The Company remains confident that the markets in which it competes remain attractive over the long term, and that growth will return as the impact of COVID-19 diminishes.

Integra’s financial position and liquidity remain strong. In early February, the Company renegotiated the terms of its $2.2 billion bank facility, extended the maturity of its credit agreement by two years to 2025, and issued a $575 million convertible note with a 0.5% fixed interest rate. Inclusive of these 2020 transactions, the 2019 year-end balances would have been a cash balance of $321 million, net debt of $1.3 billion and a bank leverage ratio of about 3.0 times.

First Quarter 2020 Financial Results Conference Call
The Company will release full first quarter 2020 financial results on Thursday, May 7, prior to market open. In conjunction with the earnings release, Integra’s management team will host a conference call at 8:30 a.m. ET.
The live call is accessible by dialing (800) 263-0877 and using the passcode 5089204. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.
A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until May 12, 2020 by dialing (888) 203-1112 and using the passcode 5089204.

On April 7, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2020 results on Wednesday, April 22, 2020, before the market opens (Press release, Quest Diagnostics, APR 7, 2020, View Source [SID1234556166]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The company also will provide an update on the impact of the COVID-19 pandemic. 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 pandemic on its operating results, cash flows and financial condition and withdraw its previously announced guidance for full year 2020.

The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on 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.

On April 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of cervical cancer (Press release, Agenus, APR 7, 2020, View Source [SID1234556165]). This designation was based on comprehensive data that support the potential for balstilimab to address a significant unmet medical need. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second line cervical cancer," said Dr. Anna Wijatyk, Head of Clinical Development, Agenus. "The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review, and we are excited to work with the FDA to quickly advance novel agents for women who suffer from metastatic cervical cancer."

Agenus has updated data from a pre-planned interim analysis revealing robust and durable activity for balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The data for the combination demonstrated 26.5% objective response rates (ORR) (4 CRs, 5 PRs) which are durable (median not yet reached) and for balstilimab monotherapy, a 14.3% ORR (1 CR, 5 PRs) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizumab.

Fast Track designation1 is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a Biologic Licensing Application (BLA).

On April 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of cervical cancer (Press release, Agenus, APR 7, 2020, View Source [SID1234556165]). This designation was based on comprehensive data that support the potential for balstilimab to address a significant unmet medical need. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second line cervical cancer," said Dr. Anna Wijatyk, Head of Clinical Development, Agenus. "The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review, and we are excited to work with the FDA to quickly advance novel agents for women who suffer from metastatic cervical cancer."

Agenus has updated data from a pre-planned interim analysis revealing robust and durable activity for balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The data for the combination demonstrated 26.5% objective response rates (ORR) (4 CRs, 5 PRs) which are durable (median not yet reached) and for balstilimab monotherapy, a 14.3% ORR (1 CR, 5 PRs) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizumab.

Fast Track designation1 is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a Biologic Licensing Application (BLA).

On April 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of cervical cancer (Press release, Agenus, APR 7, 2020, View Source [SID1234556165]). This designation was based on comprehensive data that support the potential for balstilimab to address a significant unmet medical need. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second line cervical cancer," said Dr. Anna Wijatyk, Head of Clinical Development, Agenus. "The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review, and we are excited to work with the FDA to quickly advance novel agents for women who suffer from metastatic cervical cancer."

Agenus has updated data from a pre-planned interim analysis revealing robust and durable activity for balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The data for the combination demonstrated 26.5% objective response rates (ORR) (4 CRs, 5 PRs) which are durable (median not yet reached) and for balstilimab monotherapy, a 14.3% ORR (1 CR, 5 PRs) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizumab.

Fast Track designation1 is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a Biologic Licensing Application (BLA).