On April 13, 2020 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported preliminary unaudited revenue for UDENYCA and net income for the quarter ended March 31, 2020 (Press release, Coherus Biosciences, APR 13, 2020, View Source [SID1234556258]). Coherus also provided an update on the impact of COVID-19 for first quarter 2020 as well as additional insights on COVID-19 impact for the balance of 2020.

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First Quarter 2020 Financials and Update

The Company expects preliminary unaudited first quarter 2020 net product revenue to be between $115.0 million and $117.5 million, a 210% to 217% increase compared to the net product revenue of $37.1 million for the first quarter of 2019. Preliminary unaudited first quarter 2020 net income is expected to be between $33.5 million and $38.0 million, compared to a net loss of $(20.0) million for the first quarter of 2019. These financial results reflect a modest COVID-19 impact in March 2020.

First quarter 2020 showed good unit growth for the pegfilgrastim class with the last four weeks of March having 6% growth over the previous four weeks according to the IQVIA March 27, 2020 report. A 6% increase, year-over-year, for pegfilgrastim was also seen according to the report. Specifically, UDENYCA saw a 7% unit growth in the last four weeks ending March 27, 2020 over the previous four weeks as the COVID-19 crisis accelerated.

Second Quarter 2020 and Second Half 2020 Insights

There are reasons to expect that the adverse effects we are experiencing and expect to continue to experience from COVID-19 in the second quarter and second half of 2020 will be transient and most significant during the period that the COVID-19 pandemic is having its greatest impact on the medical system and personal behaviors. We expect that patients and physicians will balance the need for the administration of drugs, such as pegfilgrastim, which are indicated for curable cancer treatment or other serious diseases against the risks associated with COVID-19.

Patients who have already initiated chemotherapy, especially with curative intent, appear to be continuing on therapy, as any dose reduction or delay could have a significant impact on survival.

Coherus believes referrals and cancer diagnoses could recover as referring providers determine ways to navigate the new environment and previously delayed treatments are initiated.

"We think it’s important when projecting second quarter COVID-19 impact to look primarily at recent pegfilgrastim sales and demand data in the context of current customer feedback, and not to impute trends from other drugs such as antiemetics. Additionally, any preliminary usage trends for such drugs at an early stage of the Covid-19 crisis may not be good predictive models for overall pegfilgrastim use, or pegfilgrastim use during the second quarter of 2020," stated Chris Thompson, Senior Vice President, Sales at Coherus.

Declines in referrals and cancer diagnoses are potentially compensated for by revised National Comprehensive Cancer Network ("NCCN") treatment guidelines that recommend growth factor use in chemotherapy regimens where there is at least a 10% risk of febrile neutropenia. This new guidance expands the previous guidelines of a greater than 20% risk of febrile neutropenia, thereby potentially increasing overall usage of pegfilgrastim.

On April 13, 2020 Danaher Corporation (NYSE: DHR) ("Danaher" or "the Company") reported that for the quarter ended April 3, 2020 it expects revenue growth of approximately 3.0% and non-GAAP core revenue growth of approximately 4.5% (Press release, Danaher, APR 13, 2020, View Source [SID1234556274]).

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President and CEO Thomas P. Joyce, Jr. said, "We anticipate positive results in each of our three reporting segments in the first quarter, with particular strength in our Cepheid, Radiometer, Pall and ChemTreat businesses. While we had a good start to the year, we saw a meaningful slowdown in demand toward the end of the quarter, particularly in our more instrument-oriented businesses, as the COVID-19 pandemic spread worldwide."

Joyce continued, "We are incredibly proud of our team’s response to these unprecedented challenges. We are directly contributing to the fight against this virus, providing much-needed diagnostic testing capabilities and supporting our customers in pursuit of new treatments and vaccines."

Due to the evolving and uncertain impact of the COVID-19 pandemic, Danaher also announced that it is withdrawing its previously communicated 2020 financial guidance, which was provided on January 30, 2020.

The Company will report first quarter 2020 financial results on Thursday, May 7, 2020. Danaher will webcast its quarterly earnings conference call beginning at 8:00 a.m. ET and lasting approximately 1 hour.

The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

You can access the conference call by dialing 866-503-8675 within the U.S. or +1 786-815-8792 outside the U.S. a few minutes before 8:00 a.m. ET and notifying the operator that you are dialing in for Danaher’s earnings conference call (access code 3845297). A replay of the conference call will be available shortly after the conclusion of the call until May 21, 2020. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations."

Danaher’s earnings press release, the webcast slides and other related presentation materials will be posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings" beginning at 6:00 a.m. ET on the date of the earnings call and will remain available following the call.

On April 13, 2020 Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for the company’s New Drug Application (NDA) for PEDMARK (a unique formulation of sodium thiosulfate) (Press release, Fennec Pharmaceuticals, APR 13, 2020, View Source [SID1234556259]). PEDMARK is an investigational drug for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to <18 years of age with localized, non-metastatic, solid tumors.

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"The FDA filing acceptance of our NDA and granting of Priority Review represents a significant milestone in the development of PEDMARK and we look forward to working closely with the Agency during this review process," said Rosty Raykov, chief executive officer of Fennec.

The FDA grants Priority Review to applications for medicines that treat a serious condition, and, if approved, would demonstrate the potential to be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Priority Review designation shortens the review period from the standard ten months to six months from the submission of the NDA. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of August 10, 2020 for the completion of FDA’s review.

About PEDMARK

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The FDA has accepted for filing the Company’s New Drug Application (NDA) for PEDMARK and has granted Priority Review. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename to be determined) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.

On April 13, 2020 DaVita Inc. (NYSE: DVA), reported that it will hold its quarterly conference call to discuss first quarter results on Tuesday, May 5, 2020, at 5:00 p.m. Eastern Time (Press release, DaVita, APR 13, 2020, View Source [SID1234556275]). The company plans to release its results after market close the same day.

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This call is also being webcast and can be accessed at the DaVita IR web page. You can join this call as follows:

Tuesday, May 5, 2020
Starting at 5:00 p.m. EDT
Dial in number: 877-918-6630
International dial in: 517-308-9042
Webcast: investors.davita.com

When calling in, please provide the operator the password "Earnings" and provide your name and company affiliation. Investors unable to listen to the conference call will be able to access a replay via our website at investors.davita.com. There will be no telephone replay.

On April 13, 2020 IntegraGen reported the company’s MERCURY cloud-based analytical software tool has achieved Conformité Européenne (CE) marking (Press release, Integragen, APR 13, 2020, View Source [SID1234556260]). This registration enhances the ability for IntegraGen sell MERCURY throughout the European Union (EU). MERCURY is utilized by researchers and clinicians to assist with the analysis of sequencing data derived from small and large gene sequencing panels as well as whole exome, RNA-Seq and whole genome sequencing.

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CE-IVD marking of MERCURY indicates that it meets the provisions of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Click here to view MERCURY’s CE Declaration of Conformity certificate.

The cloud-based platform utilized by MERCURY also regularly undergoes independent verification of security, privacy, and compliance controls, achieving certifications in line with global standards. Learn more about how IntegraGen ensures the security and privacy of genomic data.