On August 3, 2020 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines to fight against infectious diseases including COVID-19, reported that it will hold a conference call and webcast on Wednesday, August 12, 2020 at 8:00 a.m. ET to discuss the company’s second quarter 2020 financial and operational results (Press release, IMV, AUG 3, 2020, View Source [SID1234562716]).

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Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID: 2593517.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On August 3, 2020 McKesson Corporation (NYSE:MCK) reported results for the first quarter ended June 30, 2020 (Press release, McKesson, AUG 3, 2020, View Source [SID1234562715]).

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"I am proud of the dedication and discipline of McKesson’s employees as we navigate the complexities and uncertainties of the COVID-19 pandemic while continuing to serve our customers and our communities" said Brian Tyler, chief executive officer. "Thanks to the strong execution of our employees around the world, McKesson delivered first-quarter results ahead of our original expectations, as volumes across the business improved earlier than anticipated. Based on our first-quarter performance and current outlook for the remainder of the year, we are raising our previous guidance range for fiscal 2021 and now expect Adjusted Earnings per diluted share of $14.70 to $15.50".

First-quarter revenues were $55.7 billion, flat year-over-year, as market growth and higher volumes from retail national account customers within the U.S Pharmaceutical and Specialty Solutions segment were largely offset by the impact of lower prescription volumes and primary care patient visits across the enterprise.

First-quarter Earnings per diluted share of $2.72 included an after-tax net gain of $97 million for insurance proceeds received in connection with the settlement of the shareholder derivative action related to McKesson’s controlled substances monitoring program.

First-quarter Adjusted Earnings per diluted share was $2.77 compared to $3.31 a year ago, a decrease of 16%, driven by the impact of lower prescription volumes and primary care patient visits and the lapping of the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"), partially offset by a lower share count.

For the first quarter, McKesson used cash from operations of $1.1 billion, returned $74 million to shareholders via dividend payments, and invested $117 million internally, resulting in negative Free Cash Flow of $1.2 billion.

U.S. Pharmaceutical and Specialty Solutions Segment

First-quarter revenues were $45.1 billion, up 2%, driven by market growth and higher volumes from retail national account customers, partially offset by branded to generic conversions and lower prescription volumes in the quarter.
First-quarter Segment Operating Profit was $608 million and operating margin was 1.35%. Adjusted Segment Operating Profit was $589 million, down 2% from a year ago, driven by lower prescription volumes, partially offset by growth in the specialty provider business. Adjusted operating margin was 1.31%, down 5 basis points.
European Pharmaceutical Solutions Segment

First-quarter revenues were $6.2 billion, down 7% on a reported basis and down 4% on an FX-Adjusted basis, primarily driven by lower volumes in the pharmaceutical distribution business.
First-quarter Segment Operating Loss was ($10) million and operating margin was (0.16%), and included restructuring charges related to our business in the U.K. Adjusted Segment Operating Profit was $35 million, flat on a reported basis. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $36 million, up 3%, driven by lower operating expenses, partially offset by lower volumes in the pharmaceutical distribution and retail pharmacy businesses. On both a reported and FX-Adjusted basis, adjusted operating margin was 0.56%, up 4 basis points.
Medical-Surgical Solutions Segment

First-quarter revenues were $1.8 billion, down 5%, driven by declines in primary care patient visits, partially offset by higher volumes of personal protective equipment.
First-quarter Segment Operating Profit was $89 million and operating margin was 4.94%. Adjusted Segment Operating Profit was $124 million, down 22%, driven by declines in primary care patient visits. Adjusted operating margin was 6.89%, down from 8.36% in the prior year.
Other remaining businesses

First-quarter revenues were $2.6 billion, down 13% on a reported basis and down 10% on an FX-Adjusted basis, driven by lower pharmaceutical volumes in the Canadian business.
First-quarter Segment Operating Profit was $98 million, down 30%. Adjusted Segment Operating Profit was $137 million, down 50% on both a reported and FX-Adjusted basis, driven by the lapping of the prior year contribution of $108 million from the company’s investment in Change Healthcare and the negative impact of lower prescription volume trends within the Canadian and MRxTS businesses.
Company Updates

On July 29, 2020, McKesson’s Board of Directors declared an increase in the regular quarterly dividend to 42 cents per share of common stock, demonstrating McKesson’s commitment to returning cash to shareholders and confidence in its outlook.
On July 1, 2020, McKesson announced the realignment of its reportable segments commencing in the second quarter of fiscal 2021.
McKesson appointed Tom Rodgers as Executive Vice President and Chief Strategy and Business Development Officer effective June 5, 2020.
For the fifth year in a row, McKesson was named a ‘Best Place to Work’ for Disability Inclusion. McKesson earned a top-ranking score of 100 on the 2020 Disability Equality Index (DEI), a joint initiative of the American Association of People with Disabilities (AAPD) and Disability:IN.
Fiscal 2021 Outlook

McKesson raised fiscal 2021 Adjusted Earnings per diluted share guidance to $14.70 to $15.50 from the previous range of $13.95 to $14.75 to reflect earlier improvement in volumes relative to original expectations. McKesson continues to expect Adjusted Earnings per diluted share growth in the second half of fiscal 2021.

Conference Call Details

The company has scheduled a conference call for today, Monday, August 3rd at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Baird Global Healthcare Conference, September 9, 2020
Morgan Stanley 18th Annual Global Healthcare Conference, September 15, 2020
Webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’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 Equity Income from Change Healthcare, Adjusted Income from Continuing Operations Before Income Taxes, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, 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, gains from antitrust legal settlements, 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.

On August 3, 2020 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (Nasdaq: ANIP) reported that Nikhil Lalwani has been named the Company’s President and Chief Executive Officer, effective September 8, 2020 (Press release, ANI Pharmaceuticals, AUG 3, 2020, View Source [SID1234562713])
. Mr. Lalwani will also be elected to the Company’s Board of Directors, effective upon his start date. Mr. Lalwani will succeed Patrick D. Walsh, who will continue to serve as Interim President and CEO until Mr. Lalwani joins the Company and who will remain as Chairman of the Board.

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"We are delighted to welcome Nikhil to ANI Pharmaceuticals. With his proven ability to create high-growth cultures and deliver financial results, together with his operational experience in both generics and specialty pharmaceuticals, Nikhil is an ideal choice to lead our next phase of growth and to achieve our corporate objectives," stated Patrick Walsh, Interim President and Chief Executive Officer of ANI Pharmaceuticals.

"Nikhil’s track record of building strong performance-based environments and his experience in strategic planning and acquisitions, marketing, P&L optimization, and product development and commercialization, will complement our senior team as we advance our lead product candidate, Cortrophin Gel, and pursue additional strategic expansion opportunities," concluded Walsh.

"I am delighted to join ANI Pharmaceuticals at an exciting time for the business. ANI has an attractive product mix, a robust pipeline of commercial opportunities, including the Cortrophin Gel opportunity, and expansion potential in North American-based contract manufacturing. I look forward to working with the Board of Directors and all of the dedicated employees of ANI to realize the full potential of the Company’s diverse products and services, and to ensure access to our cost effective therapeutics for the patients, physicians and payors we serve," said Nikhil Lalwani.

Mr. Lalwani is a proven executive who brings over 20 years of pharmaceutical and healthcare industry experience to ANI. Mr. Lalwani recently served as CEO of Cipla USA, a top 10 pharmaceutical company, and the U.S. subsidiary of Cipla Ltd (NSE: CIPLA), a global pharmaceutical company with a focus on respiratory, anti-retroviral, oncology, urology, cardiology, anti-infective and CNS segments. Mr. Lalwani held positions of increasing responsibility while at Cipla, including CEO of InvaGen, Head of US Strategy, M&A & Integration, and Head of Cipla’s Global Respiratory business. In these roles, Mr. Lalwani developed and executed multi-year strategic growth plans for key products and facilitated successful acquisitions as Cipla entered the specialty pharmaceutical space. Prior to Cipla, Mr. Lalwani was an Associate Partner with McKinsey & Company serving pharmaceutical and healthcare companies across the world, and an engineer with Medtronic.

Mr. Lalwani earned an MBA from the Wharton School at the University of Pennsylvania and graduated Summa Cum Laude with a B.S. in Electrical Engineering from the Georgia Institute of Technology in Atlanta.

On August 3, 2020 PharmaCyte Biotech (OTCQB: PMCB) reported that it has reached what can only be described as a momentous milestone in its history and what should be considered a remarkable moment for any small biotech—the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, AUG 3, 2020, View Source [SID1234562712]). This upcoming interaction with the FDA to request a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) is the product of years of meticulous work and dedication to the development of a treatment for the third leading cause of cancer-related deaths in the United States.

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Pancreatic cancer is a hard-to-treat disease with only a 9% five-year survival rate, so the recent announcement that PharmaCyte’s partner, Austrianova, has submitted a Drug Master File (DMF) to the FDA is welcomed news because it symbolizes the IND package that we expect will be submitted to the FDA early this month (August) is very near completion.

PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, said "We’ve reached an exciting milestone at PharmaCyte that has us on the precipice of reaching our long-awaited goal of submitting an IND. We’re elated to announce that our partner, Austrianova, submitted a DMF with the FDA for the production of our Cell-in-a-Box encapsulated cell product CypCaps. This DMF is an important and significant event since it is the last prerequisite for the formal FDA application process. It will support and now facilitate the submission of our IND."

Dr. Brian Salmons, the CEO and President at Austrianova, said, "The DMF provides all of the confidential and detailed, comprehensive, information covering the production of Cell-in-a-Box encapsulated cell products, including PharmaCyte’s CypCaps product.

"As you well know, the DMF is an important milestone event that represents a culmination of many years of work on the GMP-production process, the studies that led to the parameters chosen, the materials used in the manufacturing and their specs, processing, packaging, and storing of the Cell-in-a-Box encapsulated cell products, including CypCaps. It also provides detailed information on Austrianova’s production facilities in Thailand where the CypCaps product is produced under GMP."

Of note, a DMF is a prerequisite to securing approval and commercialization and "ensures confidentiality of proprietary information" related to the Active Pharmaceutical Ingredient (API). It is this confidentiality that is sacred to both Austrianova and PharmaCyte and exactly why it’s one of the very last items to be crossed off the lengthy checklist before the IND can be submitted.

Dr. Salmons agrees, "Information on the drug product must be included in the IND and detailed information on, among other things, the manufacture and testing of the drug product, is contained in the DMF. So, in a way, it can be considered the final piece of the puzzle."

In reality, just 2 items remain before PharmaCyte can submit its IND and both will likely be accomplished in the coming days. In a June 23rd press release, PharmaCyte announced a list of tasks that needed to be completed before it could submit its IND to the U.S. FDA. Most of that work was performed by PharmaCyte’s consultants and has been completed.

PharmaCyte’s CEO, commenting on the status of the IND, said, "Virtually all of the IND has been completed. During the last few months, we have completed the Trial Protocol, the Investigator’s Brochure, the Environmental Analysis, the General Investigation Plan, the Introduction Summary, the Nonclinical Overview, the Clinical Overview, the Nonclinical Written and Tabulated Summaries, the Pharmacy Manual, the Study Reports and related information of the prior clinical studies pertinent to the treatment for LAPC, the Regulatory Publishing of the IND and supporting documents, and the Drug Master File. Some of these documents are being updated with new data.

"So, we’re now left with completing the Informed Consent, which is being prepared by our Principal Investigator, Dr. Manuel Hidalgo and his staff, and we need to hire a Chief Medical Officer (CMO) in oncology to represent the company’s interest in the planned clinical trial. Two well-qualified candidates have been interviewed and the selection process is nearly complete. We expect that both the Informed Consent and the hiring of a CMO should be completed over the next week. When this is complete, we plan to file the long-awaited IND."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On August 3, 2020 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will present a corporate overview at the 2020 BTIG Virtual Biotechnology Conference on Monday, August 10th, at 11:30 am EDT (Press release, Tracon Pharmaceuticals, AUG 3, 2020, View Source [SID1234562711]).

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To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com.