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.

NuVasive Announces Third Quarter 2020 Financial Results

On October 29, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter ended September 30, 2020 (Press release, NuVasive, OCT 29, 2020, View Source [SID1234569427]).

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Third Quarter 2020 Highlights

Net sales increased 1.5% to $295.3 million, or 1.2% on a constant currency basis;
GAAP operating margin of 9.2%; Non-GAAP operating margin of 15.8%; and
GAAP diluted earnings per share of $0.11; Non-GAAP diluted earnings per share of $0.55.
"In the third quarter, NuVasive experienced faster-than-anticipated recovery from the impact of COVID-19 with net sales increasing year over year driven by high-single digit growth in our International business and further stability of the US spine market," said J. Christopher Barry, chief executive officer of NuVasive. "The Company remains focused in the fourth quarter on executing against its innovation roadmap, including the launch of our re-designed cervical portfolio, the furthering of our Advanced Materials Science implant portfolio with multiple new implants and executing on key Pulse milestones."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release. NuVasive announced in April 2020 that it had withdrawn its annual financial guidance due to the uncertainty related to COVID-19, and is not reinstituting its annual financial guidance for the remainder of the year.

Third Quarter 2020 Results
NuVasive reported third quarter 2020 total net sales of $295.3 million, a 1.5% increase compared to $290.8 million for the third quarter 2019. On a constant currency basis, third quarter 2020 total net sales increased 1.2% compared to the same period last year.

For the third quarter 2020, both GAAP and non-GAAP gross profit was $210.6 million and GAAP and non-GAAP gross margin was 71.3%. These results compared to GAAP and non-GAAP gross profit of $213.8 million and GAAP and non-GAAP gross margin of 73.5%, for the third quarter 2019.

The Company reported GAAP net income of $5.9 million, or diluted earnings per share of $0.11, for the third quarter 2020, compared to GAAP net income of $11.0 million, or diluted earnings per share of $0.21, for the third quarter 2019. On a non-GAAP basis, the Company reported net income of $28.3 million, or diluted earnings per share of $0.55, for the third quarter 2020, compared to non-GAAP net income of $30.9 million, or diluted earnings per share of $0.59, for the third quarter 2019.

The Company ended the quarter with $982.1 million in cash and cash equivalents, and short term investments.

Supplementary Financial Information
For additional financial detail, please visit the Investor Relations section of the Company’s website at www.nuvasive.com to access Supplementary Financial Information.

Reconciliation of GAAP to Non-GAAP Information
Management uses certain non-GAAP financial measures such as non-GAAP diluted earnings per share, non-GAAP net income, non-GAAP operating expenses and non-GAAP operating margin, which exclude amortization of intangible assets, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses from strategic investments, gains and losses from changes in fair value of derivatives and non-cash interest expense (excluding debt issuance cost). Management also uses certain non-GAAP measures which are intended to exclude the impact of foreign exchange currency fluctuations. The measure constant currency utilizes an exchange rate that eliminates fluctuations when calculating financial performance numbers. The Company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital. Additionally, the Company uses an adjusted EBITDA measure which represents earnings before interest, taxes, depreciation and amortization and excludes the impact of stock-based compensation, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses on strategic investments, gains and losses from changes in fair value of derivatives and other significant one-time items.

Management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to further and more consistently analyze the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional information to enable them to assess, in the same way management assesses, the Company’s current and future continuing operations. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

BioLife Solutions to Report Third Quarter 2020 Financial Results and Provide Business Update on November 5, 2020

On October 29, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction products and services for cell and gene therapies, reported that the Company’s third quarter 2020 financial results will be released after market close on Thursday, November 5th, 2020, and that the Company will host a conference call and live webcast at 4:30 p.m. ET (1:30 p.m. PT) that afternoon (Press release, BioLife Solutions, OCT 29, 2020, View Source [SID1234569425]). Management will provide an overview of the Company’s financial results and a general business update.

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To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you may access the live conference call by dialing 1 (844) 825-0512 with the following Conference ID: 1296883. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.

AcelRx to Host Third Quarter 2020 Financial Results Call and Webcast on Thursday, November 5, 2020

On October 29, 2020 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release third quarter financial results after market close on Thursday, November 5, 2020 (Press release, AcelRx Pharmaceuticals, OCT 29, 2020, View Source [SID1234569424]). AcelRx management will host a live webcast and conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on November 5, 2020 to discuss the financial results and provide an update on the company’s business.

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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

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The webcast is accessible by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4204 for international callers.