Ziopharm Oncology to Report Third Quarter Financial Results on November 8, 2021

On November 1, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported that it will report financial results for the third quarter ended September 30, 2021 on Monday, November 8, 2021, after the close of U.S. markets (Press release, Ziopharm, NOV 1, 2021, View Source [SID1234594013]). Following the announcement, the Company will host a conference call and webcast at 4:30 p.m. ET to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 877-451-6152 (United States) or 201-389-0879 (International) with the conference code 13724384. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. After the live webcast, the event will be archived on Ziopharm’s website for approximately 90 days after the call.

McKesson Reports Fiscal 2022 Second-Quarter Results

On November 1, 2021 McKesson Corporation (NYSE:MCK) reported strong second-quarter results for the period ended September 30, 2021 (Press release, McKesson, NOV 1, 2021, View Source [SID1234594011]).

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"Our enterprise strategy is enabling us to successfully navigate a dynamic environment. McKesson delivered strong second-quarter results, including double-digit Adjusted Operating Profit growth across all segments," said Brian Tyler, chief executive officer. "We remain committed to investing in our growth strategies of biopharma services and oncology ecosystems, while simultaneously increasing shareholder returns."

"We continue to play a central role in the COVID-19 response efforts. As a result of our strong first half performance and outlook for the remainder of the year, we are raising our previous guidance range for fiscal 2022 Adjusted Earnings per Diluted Share to $21.95 to $22.55."

Second-quarter revenues were $66.6 billion, an increase of 9% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to increased specialty volumes and market growth, partially offset by branded to generic conversions.

Second-quarter earnings per diluted share from continuing operations of $1.71 included an after-tax charge of $472 million primarily for the fair value remeasurement related to McKesson’s sale of certain European businesses to the PHOENIX Group. McKesson also incurred an after-tax loss of $141 million on debt extinguishment related to a recent tender offer in the second quarter of fiscal 2022. Second-quarter Adjusted Earnings per Diluted Share does not include these charges.

Second-quarter Adjusted Earnings per Diluted Share was $6.15 compared to $4.80 a year ago, an increase of 28%, driven by the contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government and growth in the Medical-Surgical Solutions segment, partially offset by a higher tax rate compared to the prior year. Second-quarter Adjusted Earnings per Diluted Share also included pre-tax net gains of approximately $97 million, or $0.46 per diluted share, associated with McKesson Ventures’ equity investments, compared to $49 million in the second quarter of fiscal 2021.

For the first six months of the fiscal year, McKesson returned $1.4 billion of cash to shareholders, which included $1.3 billion of common stock repurchases and $134 million of dividend payments. During the first six months of the fiscal year, McKesson generated cash from operations of $170 million, and invested $279 million in capital expenditures, resulting in negative Free Cash Flow of $109 million.

Business Highlights

U.S. Pharmaceutical’s operational excellence and capabilities was demonstrated by the successful shipment of over 311 million COVID-19 vaccines on behalf of the U.S. government through October 28, 2021, including vaccine distribution in the U.S. and related to the U.S. government’s international donation mission.
Medical-Surgical Solutions recently expanded its partnership with the U.S. government to support the COVID-19 response efforts through an additional kitting and storage contract of COVID-19 ancillary supplies.
McKesson continued to progress in its planned exit from Europe:
Announced on November 1, 2021 an agreement to sell its retail and distribution businesses in the U.K. to Aurelius.
Recorded after-tax loss of $472 million related to the previously announced agreement to sell businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group.
U.S. Pharmaceutical Segment

Second-quarter revenues were $53.4 billion, an increase of 11%, driven by increased specialty volumes and market growth, partially offset by branded to generic conversions.
Second-quarter Segment Operating Profit was $760 million. Adjusted Segment Operating Profit was $735 million, an increase of 12%, driven by growth in distribution of specialty products to providers and health systems and the contribution from COVID-19 vaccine distribution.
Prescription Technology Solutions Segment

Second-quarter revenues were $932 million, an increase of 40%, driven by higher volumes of technology and service offerings to support biopharma customers and growth of prescription volumes.
Second-quarter Segment Operating Profit was $128 million. Adjusted Segment Operating Profit was $144 million, an increase of 38%, driven by core growth from access and adherence solutions.
Medical-Surgical Solutions Segment

Second-quarter revenues were $3.1 billion, an increase of 23%, driven by increased sales of COVID-19 tests and growth in the primary care business.
Second-quarter Segment Operating Profit was $296 million. Adjusted Segment Operating Profit was $319 million, an increase of 52%, driven by increased sales of COVID-19 tests, improvements in primary care patient visits, and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
International Segment

Second-quarter revenues were $9.1 billion. On an FX-Adjusted basis, revenues were $8.8 billion, a decline of 8%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance which was completed during the third quarter of fiscal 2021, partially offset by volume recovery in the pharmaceutical distribution and retail businesses.
Second-quarter Segment Operating Loss was ($146) million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $155 million, an increase of 34%, driven by the discontinued recording of depreciation and amortization on certain European assets included in the transaction with the PHOENIX Group, which were classified as held for sale beginning in the second quarter of fiscal 2022.
Company Updates

Dr. Richard H. Carmona, a former U.S. Surgeon General, joined McKesson’s Board of Directors as a new independent director and member of the Board of Directors’ Compensation and Compliance Committees effective September 6, 2021.
On September 4, 2021, McKesson announced that, under the previously announced proposed settlement agreement and process designed to resolve the opioid claims of state and local governmental entities, it was determined that enough states have agreed to settle to proceed to the next phase.
On September 28, 2021, McKesson announced that an agreement was reached with the Cherokee Nation. This settlement was negotiated in connection with ongoing negotiations toward a broad resolution of opioid-related claims brought by Native American tribes that, as previously disclosed by the companies, are not covered by the ongoing settlement process involving state and local governmental entities.
Fiscal 2022 Outlook

McKesson raised fiscal 2022 Adjusted Earnings per Diluted Share guidance to $21.95 to $22.55 from the previous range of $19.80 to $20.40 to reflect strong operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs.

Fiscal 2022 Adjusted Earnings per Diluted Share guidance includes approximately $2.30 to $3.05 of impacts, which are attributable to:

$1.30 to $1.80 related to the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs;
$0.50 to $0.75 related to COVID-19 tests and impairments for personal protective equipment and related products;
$0.49 related to year-to-date gains or losses associated with McKesson Ventures’ equity investments.
Excluding the impacts of the above items from both fiscal 2022 guidance and fiscal 2021 results, indicates 20% to 29% forecasted growth.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

McKesson has scheduled a conference call for today, Monday, November 1st at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

McKesson Investor Day

McKesson will host its Investor Day on December 8th at 1:00 PM ET. The half-day event will include presentations from Brian Tyler, chief executive officer, Britt Vitalone, chief financial officer, and other members of McKesson’s leadership team. The video webcast and additional details will be available on McKesson’s Investor Relations website.

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

J.P. Morgan 40th Annual Healthcare Conference, January 10-13, 2022
Audio webcasts will be available live and archived on McKesson’s Investor Relations website. A complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Loss on Debt Extinguishment, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

Apollo Endosurgery, Inc. Reports 28% Revenue Growth in Third Quarter
Conference Call and Webcast to Discuss Results Today at 3:30 p.m. CT / 4:30 p.m. ET

On November 1, 2021 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the third quarter ended September 30, 2021 and recent corporate highlights (Press release, Apollo Endosurgery, NOV 1, 2021, View Source [SID1234594010]).

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Third Quarter 2021 Selected Financial Results

Total revenue of $16.4 million, an increase of 28% compared to the third quarter of 2020
Endoscopic Suturing System (ESS) revenue increased 34% and Intragastric Balloon (IGB) revenue increased 21% compared to the third quarter of 2020
Gross margin of 56%
Pro forma cash of $98.3 million, including net proceeds from October 2021 follow-on offering
Recent Corporate Highlights

Announced that investigators of the Multi-Center ESG Randomized Interventional (MERIT) study reported data from the MERIT-Trial, which met its primary endpoints for safety and efficacy, with patients undergoing the Endoscopic Sleeve Gastroplasty (ESG) procedure achieving excess body weight loss of 49.2% at 12 months, improvements in weight-related comorbidities, and a serious adverse event rate of 2%;
Submitted a De Novo classification request to the U.S. Food and Drug Administration seeking 510(k) classification and clearance for the Apollo ESGTM and Apollo REVISETM devices;
Grew year-to-date revenue from Apollo’s top 10 direct accounts by 100% compared to 2020;
Continued X-Tack penetration in key accounts, with over 70% of third quarter 2021 revenue from repeat orders;
Closed a follow-on equity offering that generated net proceeds of approximately $69.9 million to support continued growth-related investments and expand the institutional shareholder base; and
Announced the publication of a multi-center study of Apollo’s X-Tack System, demonstrating high success rates, ease of use, and economic value in the treatment of GI defects.
"In the third quarter, we continued to build momentum and energize our business in the U.S. and overseas, delivering strong financial performance for both revenue and gross margin," said Chas McKhann, Apollo’s president and CEO. "Our recently completed follow-on financing enables us to thoughtfully invest in advancing large-scale opportunities to expand our addressable markets. For example, our recent De Novo 510(k) classification request for Apollo ESG and Apollo REVISE is based on well documented therapeutic solutions in categories where patients are increasingly seeking effective but less invasive alternatives. We are building a foundation for long-term value creation here at Apollo."

Third Quarter Results

Total revenues of $16.4 million for the third quarter of 2021 increased $3.5 million, or 28%, compared to $12.8 million in revenue during the third quarter of 2020. Compared to the third quarter of 2020, U.S. product sales increased 30% and OUS increased 24%.

Compared to the third quarter of 2020, total ESS product sales increased $2.6 million or 34% and total IGB product sales increased $1.0 million or 21% due to the improvement in demand for our products, the launch of X-tack product in the U.S. earlier this year, and an increase in product sales in our distributor markets compared to the prior year quarter when those markets were still destabilized from the initial impact of the COVID-19 pandemic.

Gross margin increased to 56% for the third quarter of 2021 from 55% in the third quarter of 2020 due to higher product sales and unabsorbed overhead costs from reduced production volumes in the prior year quarter as a result of the COVID-19 pandemic.

Total operating expenses increased $5.2 million compared to the third quarter of 2020. The increase was due to the normalization of temporary cost controls that were implemented in response to the pandemic in the prior year and higher non-cash stock-based compensation expense of $1.5 million in the third quarter of 2021.

Net loss for the third quarter of 2021 was $6.7 million compared to $2.6 million for the third quarter of 2020.

Non-GAAP adjusted EBITDA, which excludes interest, taxes, depreciation, amortization, unrealized foreign exchange and stock-based compensation, in the third quarter 2021 was a loss of $2.5 million, compared to a loss of $0.3 million in the third quarter 2020.

Cash, cash equivalents and restricted cash were $28.5 million as of September 30, 2021, representing a net cash burn of $2.8 million for the third quarter.

In October, the Company completed a follow-on equity offering of 9,660,000 shares for gross proceeds of $75 million.

2021 Financial Outlook

Apollo expects full year 2021 revenue between $63-$64 million. The Company continues to monitor the potential and uncertain impact of the ongoing COVID-19 pandemic. Should hospitals or outpatient centers where the company’s procedures are performed experience continued or additional surges in cases and need to defer elective procedures to preserve capacity for COVID-19 patients, the company’s ability to achieve these financial projections could be adversely affected.

Conference Call

Apollo will host a live webcast audio call with slides today at 3:30 p.m. CT / 4:30 p.m. ET. Investors are invited to join the live call via webcast from the Investors section of the Company’s corporate website at www.apolloendo.com. An audio-only option is available is available by dialing +1-973-528-0011 and referencing "Apollo Endosurgery Third Quarter 2021 Earnings Call." Investors who opt for audio-only will need to download the related slides at www.apolloendo.com.

A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com, shortly after completion of the call.

Viracta Therapeutics to Present at Upcoming Investor Conferences

On November 1, 2021 Viracta Therapeutics, Inc. (NASDAQ: VIRX), a precision oncology company targeting virus-associated malignancies, reported that company management is scheduled to present and host one-on-one meetings at the following upcoming investor conferences (Press release, Viracta Therapeutics, NOV 1, 2021, View Source [SID1234594009]):

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Credit Suisse 30th Annual Healthcare Conference (virtual)

Conference Dates:

November 8 – 12, 2021

Presentation Date:

November 11, 2021

Presentation Time:

1:50 PM ET

Format:

Corporate presentation

Jefferies London Healthcare Conference (in-person)

Conference Dates:

November 16 – 17, 2021

Presentation Date:

November 17, 2021

Presentation Time:

10:40 AM GMT/ 5:40 AM ET

Format:

Corporate presentation

Piper Sandler 33rd Annual Healthcare Conference (virtual)

Conference Dates:

November 29 – December 2, 2021

Presentation Available:

November 22, 2021, at 10:00 AM ET

Format:

Corporate presentation

Evercore ISI 4th Annual HealthCONx Conference (virtual)

Conference Dates:

November 29 – December 2, 2021

Presentation Date:

December 2, 2021

Presentation Time:

3:55 PM ET

Format:

Fireside chat

A live webcast of each of the presentations will be available under "Events and Webcasts" in the Investors section of the Viracta website at View Source Replays of each webcast will be archived on the Viracta website for at least 30 days following the presentation.

Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2021 Financial Results

On November 1, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2021 (Press release, Corvus Pharmaceuticals, NOV 1, 2021, View Source [SID1234594008]).

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"Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. This includes mupadolimab, our anti-CD73 antibody, and ciforadenant, our small molecule antagonist of the adenosine A2A receptor," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We continue to advance mupadolimab with a focus on non-small cell lung cancer (NSCLC) and HPV positive (human papilloma virus) head and neck cancers (HNSCC). Two expansion cohorts in our Phase 1b/2 trial are enrolling patients with these tumors and we are evaluating treatment with a combination of mupadolimab and pembrolizumab. We believe mupadolimab is well positioned to potentially improve patient outcomes based on its mechanism of inhibiting immunosuppressive adenosine in the tumor microenvironment and by enhancing immune responses to the tumor. Its novel immune enhancing properties are based on its known B cell stimulating activities, which have been observed in our cancer and COVID-19 clinical trials. We also continue to expand our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently received an IND approval notice in China to initiate Phase 1/1b clinical development of CPI-818 for the treatment of T cell lymphomas."

2021 Key Areas of Focus
The Company is efficiently advancing its clinical programs – mupadolimab, CPI-818 and ciforadenant – along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:

Mupadolimab for NSCLC and Head and Neck Cancer

The Company has completed enrollment of patients with NSCLC and Head and Neck Cancer in its Phase 1/1b clinical trial of mupadolimab monotherapy; combination with ciforadenant, Corvus’ small molecule inhibitor of the A2A receptor; combination with pembrolizumab; or triplet combination with ciforadenant and pembrolizumab. We anticipate that the results will be presented at the annual meeting of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2021.
Mupadolimab for HPV+ Oropharyngeal Cancer of the Head and Neck

The Company is enrolling a Phase 1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and initial results are anticipated in 2022.
Mupadolimab for NSCLC

In September 2021, the Company began enrolling patients in a Phase 1b/2 clinical trial in patients with relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the trial is response rate and results are anticipated to be reported in 2022.
Mupadolimab for Viral Associated Cancers and Viral Diseases

The Company is evaluating mupadolimab in other viral associated tumors such as cancer of the cervix and head and neck cancers caused by Epstein Barr virus (EBV), which is a member of the herpes virus family and one of the most common human viruses.
The Company is evaluating partnership opportunities to continue the development of mupadolimab as a therapeutic for the treatment of COVID-19. We believe this approach is supported by results from the Company’s discontinued Phase 3 randomized, double blind placebo-controlled clinical trial of mupadolimab for hospitalized patients with COVID-19, which were published in September. The primary endpoint of the clinical trial was the proportion of patients progressing to respiratory failure or death during the 28 days after dosing with either mupadolimab 2mg/kg, 1mg/kg or placebo. Forty patients were enrolled in the clinical trial prior to its voluntary discontinuation. In the 2mg/kg cohort, 93.3% of patients were alive and free from respiratory failure, compared to 85.7% in the 1mg/kg cohort and 81.1% in the placebo cohort. In addition, positive trends favoring mupadolimab treatment compared to placebo were seen for all the key secondary endpoints, including time to clinical improvement, time to sustained clinical improvement and time to hospital discharge. Due to the number of participants enrolled in the trial before it was discontinued, the foregoing results were not sufficiently powered for statistical significance.
CPI-818 Phase 1/1b Clinical Trial for T cell Lymphoma in Partnership with Angel Pharmaceuticals

The Company’s ongoing Phase 1/1b trial with CPI-818 has been expanded to enroll patients with certain types of T cell leukemias in addition to T cell lymphomas.
The Company’s partner in China, Angel Pharmaceuticals, plans to initiate a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas, with the potential to expand into autoimmune diseases over time. In October, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved Angel’s IND for CPI-818 and the trial is expected to open by early 2022. Angel Pharmaceuticals will be responsible for all expenses related to executing the trial in China.
Ciforadenant Phase 2 Clinical Trial for Front Line RCC

In addition to developing mupadolimab for blocking adenosine production, the Company is developing Ciforadenant, a small molecule antagonist of the adenosine A2A receptor. It is designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. The Company also discovered the Adenosine Gene Signature, which has demonstrated the potential to serve as a biomarker to identify patients most likely to respond to treatment with ciforadenant.
The Company plans to collaborate with the Kidney Cancer Consortium to initiate a Phase 2 clinical trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and another approved therapeutic agent for RCC. The clinical trial is expected to enroll up to 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies and data from earlier clinical trials with ciforadenant indicate adenosine may be a cause of resistance to current therapies with anti-PD(L)-1. Tumor biopsies will be evaluated for expression of the Adenosine Gene Signature.
Financial Results

As of September 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $76.3 million as compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $32.0 million resulted from the receipt of approximately $32 million in net proceeds from the sale of the Company’s common stock through an underwritten offering, approximately $29 million in net proceeds from the Company’s at the market equity offering program, and approximately $1 million in proceeds from the exercise of common stock options and was reduced by approximately $30 million of cash used in operating activities in the nine months ended September 30, 2021. Consistent with last quarter, Corvus expects full year 2021 net cash used in operating activities to be approximately $36 million, resulting in a projected balance of cash, cash equivalents and marketable securities of approximately $70 million at December 31, 2021.

Research and development expenses for the three months ended September 30, 2021 totaled $7.0 million compared to $6.6 million for the same period in 2020. The increase of $0.4 million was primarily due to an increase in clinical trial costs.

The net loss for the three months ended September 30, 2021 was $10.7 million compared to a net loss of $9.8 million for the same period in 2020. Total stock compensation expense for the three months ended September 30, 2021 was $1.1 million compared to $1.3 million for the same period in 2020.