Coherus BioSciences to Report First Quarter Financial Results on May 7th

On April 22, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported that its first quarter 2020 financial results will be released after market close on Thursday, May 7, 2020 (Press release, Coherus Biosciences, APR 22, 2020, View Source [SID1234556498]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update.

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After releasing first quarter financial results, the Company will post them on the Coherus website at View Source

Conference Call Information

When: Thursday, May 7, 2020 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (Toll Free) or (765) 507-2587 (International)
Conference ID: 6167564

FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple Negative Breast Cancer

On April 22, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that the U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease (Press release, Immunomedics, APR 22, 2020, View Source [SID1234556497]). Trodelvy is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC.1

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Trodelvy, which was granted Breakthrough Therapy Designation and Priority Review, was approved under the FDA’s Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase 2 study. Continued approval may be contingent upon verification of clinical benefit in the confirmatory Phase 3 ASCENT study, which was recently halted by the independent Data Safety Monitoring Committee (DSMC) for compelling evidence of efficacy across multiple endpoints.

"The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease," stated Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and Assistant Professor of Medicine at Harvard Medical School. Dr. Bardia was the lead investigator of the Phase 2 study. "In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer."

In the single-arm Phase 2 study, Trodelvy demonstrated an ORR of 33.3 percent (95 percent CI: 24.6, 43.1) and a median DoR of 7.7 months (95 percent CI: 4.9, 10.8), as determined by local assessment, in 108 adult TNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting (range: 2-10).1

"We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer," said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. "This approval highlights the potential of our unique ADC platform and strengthens the premise that the Trop-2 antigen found in many solid cancers is an important target for drug delivery. We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need."

Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease.1

"Trodelvy’s approval is a major milestone in our transformation from a research-based organization to a fully-integrated biopharmaceutical company, underscoring our commitment to bring innovative therapies to patients with hard-to-treat cancers," said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "We are grateful to all of the patients, their families, physicians, and nurses who participated in our clinical trials and played a significant role in making this moment possible."

The Company recently announced that the Phase 3 confirmatory ASCENT study of Trodelvy in metastatic TNBC, with over 500 patients enrolled, will be stopped early due to compelling efficacy across multiple endpoints, based on the unanimous recommendation of the DSMC. The Company remains on track to achieve topline results from the ASCENT study by mid-2020.

Conference Call

The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss the FDA approval. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 4987526. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

About TRODELVY

Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics’ unique antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers, making it an attractive target for Trodelvy to potentially address multiple types of cancer.2 Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells. Trodelvy is currently being evaluated as a treatment for eight hard-to-treat solid cancers.

About triple-negative breast cancer

Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer, accounting for up to 20 percent of all breast cancers.3 TNBC is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American and Hispanic women.4 TNBC cells do not have estrogen or progesterone hormone receptors, or very much of the human epidermal growth factor receptor 2 – hence the term triple negative. This means that medicines that target these receptors are not typically effective in TNBC. There is currently no approved standard of care for people with previously-treated mTNBC.3

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.