Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer

On October 29, 2020 Roche (SIX: RO, ROG;OTCQX: RHHBY) reported U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, OCT 29, 2020, https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-the-cobas-egfr-mutation-test-v2-as-the-first-companion-diagnostic-test-for-expanded-egfr-tki-therapies-in-patients-with-non-small-cell-lung-cancer-301163170.html [SID1234569441]). This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy.

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"Clinicians can now have greater confidence in the robustness, reliability and proven clinical utility of the cobas EGFR Mutation Test v2 when evaluating lung cancer patients who may benefit from targeted EGFR TKI therapies," said Neil Gunn, Head of Roche Sequencing Solutions. "By approving a single test for a broad group of therapies, this new and innovative approach by the FDA[3] can pave the way for future EGFR TKI therapies to utilise the cobas EGFR Mutation Test v2 to help identify patients for personalised medicine."

About the cobas EGFR Mutation Test v2
The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating tumour DNA (ctDNA) from plasma derived from ethylenediamine tetraacetic acid (EDTA) anti-coagulated peripheral whole blood.

Protalix BioTherapeutics to Reschedule Third Quarter 2020 Financial Results and Business Update Call for Friday, October 30

On October 29, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it has rescheduled today’s conference call due to technical issues with a third-party provider (Press release, Protalix, OCT 29, 2020, View Source [SID1234569437]). The rescheduled call to discuss the financial results and provide a general business update will take place on Friday, October 30, 2020 at 8:30 a.m. Eastern Daylight Time (EDT). The Company reported financial results for the third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical developments in a press release issued earlier today.

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Rescheduled Conference Call and Webcast Information:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13712792

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

Cryoport to Report Third Quarter 2020 Financial Results on November 5, 2020

On October 29, 2020 Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"), a global leader in life sciences solutions, reported that the Company will report financial results for the third quarter ended September 30, 2020 on Thursday, November 5, 2020 after U.S. markets close (Press release, Cryoport, OCT 29, 2020, View Source [SID1234569434]).

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In addition to the earnings release, a document titled "Cryoport Third Quarter 2020 in Review", providing a review of Cryoport’s recent financial and operational performance and a general business update, will be issued at 4:05 pm ET on Thursday, November 5, 2020. The document is designed to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations.

Cryoport management will host a conference call at 5:00 pm ET on November 5, 2020. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding the Company’s reported results.

Conference Call Information

‘Investor Relations’ section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

Questions and answers will be recorded and available approximately three hours after completion of the live event on the Investor Relations section of the Company’s website at www.cryoport.com for a limited time. To access the replay of the questions and answers, please follow this link. A dial-in replay of the call will also be available, to those interested, until November 12, 2020. To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671 (International) and enter replay pin number: 4671157.

Concure Oncology Secures Additional $2 Million in Funding to Expand its Reach with Innovative Breast Cancer Treatment

On October 29, 2020 Concure Oncology, whose mission is to ease the burden for women facing early-stage breast cancer by providing an innovative new kind of radiation treatment option, reported that it has secured another $2 million in capital, showing continued momentum for the treatment that has been giving new hope to women battling breast cancer (Press release, Concure Oncology, OCT 29, 2020, View Source [SID1234569432]).

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This additional round of funding will allow Concure to further grow its organization and train new clinicians across the country to bring this treatment option to even more women. It follows an earlier $2 million that was raised in March and company growth in 2019 when Concure expanded its high-profile team of clinical experts in breast cancer treatment, and brings the company’s new funding to $4 million within the last 9 months, a time period that has been very difficult for early-stage medical device companies.

"This additional financing speaks to the excitement and momentum we’ve been seeing for this truly groundbreaking type of breast cancer therapy," said Scott Armstrong, chief executive officer of Concure Oncology. "With this funding, we can build out our team and give women facing breast cancer a better and more effective form of treatment as we move forward."

Breast Microseed Treatment is safe, effective and convenient in providing radiation therapy to patients with early-stage breast cancer. This technique, also known as low-dose-rate brachytherapy, is based on a similar method that has already been proven to successfully treat prostate cancer. What distinguishes this treatment from conventional radiation therapy is that it allows post-lumpectomy patients the chance to have a one-time, one-hour procedure, as opposed to the more burdensome conventional radiation that may last from three to six weeks and require daily visits to a radiation facility.

Concure Oncology’s treatment has been recognized as being as effective as traditional whole breast irradiation relative to local recurrence and overall survival rates, with excellent cosmetic outcomes as well as reported high patient satisfaction levels in peer-reviewed, published data. The procedure involves the placement of tiny, low dose-rate brachytherapy sources – or Microseeds – into the breast tissue, which release a safe but effective dose of radiation for 2-3 months to the immediate area surrounding the lumpectomy site. Once fully released, the seeds become inert, with no radioactivity remaining.

Individuals interested in clinical applications, sales or marketing roles at Concure should visit the company’s website for more information.

DaVita Inc. 3rd Quarter 2020 Results

On October 29, 2020 DaVita Inc. (NYSE: DVA) reported financial and operating results for the third quarter ended September 30, 2020 (Press release, DaVita, OCT 29, 2020, View Source [SID1234569429]). During the quarter, notwithstanding the challenges of responding to COVID-19, the Company delivered strong financial and operating results, and continued its focus on patient care and the safety of its patients, caregivers, teammates, and physician partners.

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"I am proud of the hard work and dedication of our 65,000 teammates in delivering essential, life-preserving care to our patients," said Javier Rodriguez, CEO of DaVita Inc. "Due to their efforts, we have been able to sustain continuity of care despite the disruption caused by the pandemic, while maintaining our strategic focus on leading the transformation of kidney care."

Financial results for the quarter ended September 30, 2020:

Consolidated revenues of $2.924 billion.
Operating income of $438 million or 15.0% operating margin.
Diluted earnings per share from continuing operations of $1.28 and adjusted diluted earnings per share from continuing operations of $1.80.
Operating cash flow from continuing operations of $483 million and free cash flow from continuing operations of $287 million.
Refinanced $1.5 billion of 5% senior notes with $1.5 billion of new 3.75% senior notes in August.
Deployed proceeds from issuance of $1.75 billion of 4.625% senior notes in June to redeem $1.75 billion of 5.125% senior notes in July.
Repurchased 8,231,679 shares of our common stock at an average cost of $88.13 per share, including 7,981,679 shares purchased in a "modified" Dutch auction tender offer in September.
U.S. dialysis metrics:

Volume: Total U.S. dialysis treatments for the third quarter of 2020 were 7,656,173, or an average of 96,914 treatments per day, representing a per day decrease of 0.2% compared to the third quarter of 2019. Normalized non-acquired treatment growth in the third quarter of 2020 compared to the third quarter of 2019 was 0.6%.

Primary drivers of the changes in the table above were as follows:

Revenue: The quarter change was primarily due to a decrease in commercial revenue per treatment, unfavorable changes in government payor mix and a decline in calcimimetics revenue per treatment, partially offset by increases in inpatient dialysis service revenue and Medicare rates due to the temporary suspension of Medicare sequestration. The year to date change was primarily due to favorable changes in government and commercial revenue per treatment, including an increase in Medicare rates due to the base rate increase in 2020 and the temporary suspension of Medicare sequestration, and an increase in inpatient dialysis services revenue, partially offset by a decline in calcimimetics revenue per treatment.

Patient care costs: The quarter change was primarily due to decreases in COVID-19-related costs, including compensation expense, and pharmaceutical intensity, partially offset by increases in health benefit expenses and other direct dialysis center operating expenses. The year to date change was primarily due to decreases in pharmaceutical unit costs, other direct dialysis center operating expenses, and health benefit expenses, partially offset by an increase in labor costs and COVID-19-related costs, including compensation expense.

General and administrative: The quarter change was primarily due to increases in advocacy costs, as described below, contributions to our charitable foundation and compensation expense. The year to date change was primarily due to increases in advocacy costs, as described below, contributions to our charitable foundation and compensation expense including costs related to COVID-19. These increases were partially offset by decreases in travel expenses, long-term incentive compensation expense and health benefit expenses.

Certain items impacting the quarter:

Share repurchases: The following table summarizes our common stock repurchases during the three months ended September 30, 2020.

Subsequent to September 30, 2020 through October 28, 2020, we repurchased 1,827,836 shares of our common stock for $161 million at an average cost of $87.96 per share.

Debt transactions: In August 2020, we issued $1.5 billion in aggregate principal amount of 3.75% senior notes due 2031 and used the net proceeds from these 3.75% senior notes, together with cash on hand, to redeem in full all $1.5 billion in aggregate principal amount of our outstanding 5% senior notes due 2025, including payment of accrued interest and a redemption premium. We also redeemed in full our $1.75 billion in aggregate principal amount of our outstanding 5.125% senior notes due 2024, including payment of accrued interest and a redemption premium, in July 2020 with the proceeds from our $1.75 billion in aggregate principal amount of 4.625% senior notes due 2030 issued in June 2020, together with cash on hand.

Advocacy costs: During the three months ended September 30, 2020, we incurred advocacy costs of approximately $66 million to counter union policy efforts, including a California ballot initiative. These costs are included in the U.S. dialysis segment’s general and administrative expenses.

Center activity: As of September 30, 2020, we provided dialysis services to a total of approximately 238,200 patients at 3,100 outpatient dialysis centers, of which 2,809 centers were located in the United States and 291 centers were located in nine countries outside of the United States. During the third quarter of 2020, we opened a total of 17 new dialysis centers, acquired five dialysis centers and closed eight dialysis centers in the United States. We also acquired eleven dialysis centers, opened one new dialysis center and sold or closed eight dialysis centers outside of the United States during the third quarter of 2020.

Outlook:

The following forward-looking measures and the underlying assumptions involve significant known and unknown risks and uncertainties, including those described below, and actual results may vary materially from these forward-looking measures. In particular, the widespread impact of the COVID-19 pandemic continues to generate significant risk and uncertainty, and as a result, our future results could vary materially from the guidance provided below. We do not provide guidance for diluted net income from continuing operations per share attributable to DaVita Inc., effective income tax rate on income from continuing operations or free cash flow from continuing operations on a basis consistent with United States generally accepted accounting principles (GAAP) nor a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures on a forward-looking basis because we are unable to predict certain items contained in the GAAP measures without unreasonable efforts. These non-GAAP financial measures do not include certain items, including loss on changes in ownership interests, accruals for legal matters, refinancing charges and foreign currency fluctuations, which may be significant. The guidance for our effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. also excludes the amount of third party owners’ income and related taxes attributable to non-tax paying entities.

We will be holding a conference call to discuss our results for the third quarter ended September 30, 2020, on October 29, 2020, at 5:00 p.m. Eastern Time. To join the conference call, please dial (877) 918-6630 from the U.S. or (517) 308-9042 from outside the U.S., and provide the operator the password ‘Earnings’. A replay of the conference call will be available on our website at investors.davita.com for the following 30 days.