USMI and JCRI-ABTS Receive FDA Approval to Conduct the First U.S. Clinical Trial Using Cold Atmospheric Plasma for the Treatment of Cancer

On July 31, 2019 US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS), LLC reported that the U.S. Food and Drug Administration (FDA) has approved the first clinical trial in the U.S. to evaluate Cold Atmospheric Plasma (CAP) Technology for the treatment of cancer (Press release, US Medical Innovations, JUL 31, 2019, View Source [SID1234537963]).

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USMI is the first company in the world to integrate a high frequency electrosurgical generator and plasma gas to deliver a Cold Atmospheric Plasma (Plasma Helium Beam) for the selective treatment of cancer US Patent #9,999,462 June 19, 2019 (Integrated Cold Plasma and High Frequency Plasma Electrosurgical System and Method). This novel non-thermal process has been developed for treating solid cancerous tumors. JCRI-ABTS and several plasma laboratories around the world have reported that CAP can trigger chemical and molecular changes in the cancerous cells that cause significant stress and drastically decrease the cancer cell’s viability and death. Canady Helios Cold Plasma System (CHCPS) has a selective action only on tumor cells and not healthy normal cells. CHCPS technology demonstrates a temperature equal or less than 30°C (85°F) and cause no thermal injury to normal tissue.

The Canady Helios Cold Plasma System and Canady Plasma Cold Plasma Ablator were developed by Jerome Canady, M.D. CEO, Chief Science Officer and the scientists at the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI/ABTS), USMI’s engineering team led by Taisen Zhuang, PhD VP Research & Development; Michael Keidar PhD, Professor School of Engineering and Applied Sciences, Director of Micropropulsion and Nanotechnology lab at The George Washington University (GWU); and Alex Shashurin, PhD, Assistant Professor School of Aeronautics and Astronautics at Purdue University.

Dr. Canady explained, "After the surgeon removes the cancerous tumor during surgery, CAP is subsequently sprayed at the surgical margins to target any remaining cancerous tissue or cells for 2 to 7 minutes, thus reducing the chances of cancer recurrence. We see our CAP treatment as an important adjunct to the current treatment protocols for solid cancerous tumors. The FDA has given approval for 20 patients and we plan to start the program in August 2019."

The JCRI-ABTS Translational Molecular Center has developed a robust research program targeting Breast, Ovarian, Lung, Renal Cell, Sarcoma, Prostrate, Melanoma and Gastrointestinal solid tumors.

Five Prime Therapeutics to Announce Second Quarter 2019 Financial Results and Host Conference Call

On July 31, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that will report its second quarter 2019 financial results on Wednesday, August 7, 2019 after the U.S. financial markets close (Press release, Five Prime Therapeutics, JUL 31, 2019, View Source [SID1234537962]). Five Prime will also host a conference call and live audio webcast on August 7th at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

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The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 3575436.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

Five Prime Therapeutics to Present at Upcoming Healthcare Conference

On July 31, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported that Aron Knickerbocker, Chief Executive Officer, is scheduled to present at the following investor conference (Press release, Five Prime Therapeutics, JUL 31, 2019, View Source [SID1234537961]):

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The 2019 Wedbush PacGrow Healthcare Conference Wednesday, August 14, 2019 at 8:35am ET / 5:35am PT
The presentations will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at:

View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

McKesson Reports Fiscal 2020 First-Quarter Results

On July 31, 2019 McKesson Corporation (NYSE:MCK) reported that revenues for the first quarter ended June 30, 2019, were $55.7 billion compared to $52.6 billion a year ago, an increase of 6% on a reported basis and an increase of 7% on an FX-adjusted basis (Press release, McKesson, JUL 31, 2019, View Source [SID1234537960]).

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On the basis of U.S. generally accepted accounting principles ("GAAP"), first-quarter earnings per diluted share from continuing operations was $2.27, compared to a loss per diluted share of $(0.69) a year ago.

First-quarter Adjusted Earnings per diluted share was $3.31, an increase of 14% compared to $2.90 a year ago, primarily driven by growth in the U.S. Pharmaceutical and Specialty Solutions segment and a lower share count, partially offset by a higher tax rate.

"McKesson is off to a strong start in fiscal 2020, and our first-quarter earnings performance exceeded our expectations," said Brian Tyler, chief executive officer. "Based on the momentum from our first-quarter results and our confidence in the full year outlook, we are raising our previous guidance range for fiscal 2020 and now expect Adjusted Earnings per diluted share of $14.00 to $14.60."

For the first quarter, McKesson used cash from operations of $51 million, and invested $111 million internally, resulting in negative free cash flow of $162 million. During the quarter, McKesson paid $46 million for acquisitions, and returned $759 million of cash to shareholders via $684 million of common stock repurchases and $75 million of dividend payments. The Board of Directors also approved a 5% increase in the quarterly dividend to $0.41 per share. The company ended the quarter with cash and cash equivalents of $1.9 billion.

U.S. Pharmaceutical and Specialty Solutions Segment

First-quarter revenues were $44.2 billion, up 8%, driven primarily by market growth, partially offset by branded to generic conversions. GAAP operating profit was $579 million and GAAP operating margin was 1.31%. Adjusted operating profit was $600 million, up 11%, and adjusted operating margin was 1.36%.
European Pharmaceutical Solutions Segment

First-quarter revenues were $6.7 billion, down 3% on a reported basis and up 3% on an FX-adjusted basis, driven primarily by market growth in the pharmaceutical distribution business. GAAP operating profit was $5 million and GAAP operating margin was 0.07%. Adjusted operating profit was $35 million, down 53%, and adjusted operating margin was 0.52%. On an FX-adjusted basis, adjusted operating profit was $37 million, down 50%, and adjusted operating margin was 0.52%, driven by the weak retail pharmacy environment in the U.K.
Medical-Surgical Solutions Segment

First-quarter revenues were $1.9 billion, up 12%, driven by an acquisition and growth in the Primary Care and Extended Care businesses. The aforementioned acquisition closed in the prior fiscal year on June 1, 2018, and has now been fully lapped. GAAP operating profit was $125 million and GAAP operating margin was 6.57%. Adjusted operating profit was $159 million, up 27%, and adjusted operating margin was 8.36%.
Other remaining businesses (primarily including McKesson Canada, McKesson Prescription Technology Solutions (MRxTS) and the equity method investment in the Change Healthcare Joint Venture (Change Healthcare))

First-quarter revenues were $3.0 billion, down 1% on a reported basis and up 2% on an FX-adjusted basis, driven primarily by growth in our MRxTS business. GAAP operating profit was $141 million and adjusted operating profit was $276 million, up 30%. On an FX-adjusted basis, adjusted operating profit was $279 million, up 31%.
Company Updates

Change Healthcare, Inc., a leading independent healthcare technology company, began trading on the Nasdaq Global Select Market under the trading symbol "CHNG" on June 27, 2019.
For the fourth 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 2019 Disability Equality Index (DEI), a joint initiative of the American Association of People with Disabilities (AAPD) and Disability:IN.
Dr. Ken Washington joined McKesson’s Board of Directors as a new independent director effective July 1, 2019.
Fiscal 2020 Outlook and Change Healthcare Update

McKesson raised fiscal 2020 Adjusted Earnings per diluted share guidance to $14.00 – $14.60 from a range of $13.85 – $14.45.

Following the completion of the Change Healthcare, Inc. IPO, McKesson owns approximately 58.5% of Change Healthcare, reduced from 70%. McKesson will continue to report the equity income from its interest in Change Healthcare based on its revised equity ownership percentage and with a one-month lag.

McKesson reaffirmed the guidance range for adjusted equity earnings from Change Healthcare of approximately $250 million to $270 million in fiscal 2020. This range reflects McKesson’s revised equity ownership, and includes the expected benefit of lower interest expense for Change Healthcare driven by its repayment of long-term debt.

Dividend Declaration

The company’s Board of Directors yesterday declared a 5% increase in the regular quarterly dividend to 41 cents per share of common stock. The dividend will be payable on October 1, 2019, to stockholders of record on September 3, 2019.

Conference Call Details

The company has scheduled a conference call for today, Wednesday, July 31st, at 5:00 PM ET to discuss the company’s financial performance. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source The conference call can also be accessed by dialing 323-994-2093. The password is ‘McKesson’. A telephonic replay of this conference call will be available for five calendar days. For individuals wishing to listen to the replay, the dial-in number is 719-457-0820 and the pass code is 5579684. 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 conference:

Morgan Stanley 17th Annual Global Healthcare Conference, September 9-11, 2019, in New York, New York.
Audio 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 is available on the company’s Investor Relations website.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income from continuing operations, excluding amortization of acquisition-related intangible assets, transaction-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments. A reconciliation of McKesson’s GAAP financial results to Adjusted Earnings is provided in Schedules 2 and 3 of the financial statement tables included with this release.

The company does not provide forward-looking guidance on a GAAP basis prospectively 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 and asset impairment 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.

FX-Adjusted

McKesson also presents its financial results on an FX-adjusted basis. The company conducts business worldwide in local currencies, including the Euro, British pound and Canadian dollar. As a result, the comparability of the financial results reported in U.S. dollars can be affected by changes in foreign currency exchange rates. FX-adjusted information is presented to provide a framework for assessing how the company’s business performed excluding the effect of foreign currency exchange rate fluctuations. The supplemental FX-adjusted information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

Free Cash Flow

McKesson also provides free cash flow, a non-GAAP measure. Free cash flow is defined as net cash provided by operating activities less payments for property, plant and equipment and capitalized software expenditures, as outlined in the company’s condensed consolidated statements of cash flows.

Exelixis and Aurigene Enter Into Exclusive Collaboration, Option and License Agreement to Discover and Develop Novel Therapies for Cancer

On July 31, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that it has entered into an exclusive collaboration, option and license agreement with Aurigene Discovery Technologies Limited (Aurigene), the India-based discovery biotechnology company focused on oncology and inflammatory disorders (Press release, Exelixis, JUL 31, 2019, View Source [SID1234537958]). The agreement gives Exelixis the opportunity to in-license as many as six programs from Aurigene, which has developed a focused approach to drug discovery that targets differentiated first-in-class and best-in-class opportunities with unique mechanisms of action. The deal is part of Exelixis’ ongoing strategy to build an innovative pipeline behind the company’s internally discovered, commercially available therapies, including its flagship product, CABOMETYX (cabozantinib).

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"Exelixis’ demonstrated success in bringing oncology therapies to market, as well as its own legacy of drug discovery expertise, make it a natural partner for Aurigene. We look forward to combining these complementary skills to drive potential new therapies for the patients that need them."

Under the terms of the agreement, Exelixis will make an upfront payment of $10 million for exclusive options to license three preexisting programs from Aurigene. In addition, Exelixis and Aurigene will initiate three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional option payments of $2.5 million per program. Exelixis will also contribute research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. As the programs mature, Exelixis will have the opportunity to exercise an exclusive option for each program up until the time of Investigational New Drug (IND) acceptance. If Exelixis decides to exercise an option, it will make an option exercise payment to Aurigene and assume responsibility for that program’s future clinical development and commercialization including global manufacturing. Aurigene will be eligible for clinical development, regulatory, and sales milestones, as well as royalties on sales. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.

"Aurigene has a proven track record in discovery collaborations with 14 partnered programs currently in clinical trials, including 10 trials in the United States," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "Our collaboration has the potential to enhance Exelixis’ early-stage pipeline with promising therapeutic candidates while mitigating financial risk for Exelixis through a success-based payment structure. Aurigene’s small molecule discovery expertise complements our internal discovery capabilities and gives us access to an expanded range of targets and mechanisms, including covalent inhibition and induced protein degradation. We’re excited to start working with Aurigene and are hopeful that our partnership will result in multiple clinical-stage compounds and, eventually, therapies that may benefit patients with cancer."

"Aurigene has deep expertise exploring novel mechanisms of action for discovering new, effective treatments for patients with cancer," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "Exelixis’ demonstrated success in bringing oncology therapies to market, as well as its own legacy of drug discovery expertise, make it a natural partner for Aurigene. We look forward to combining these complementary skills to drive potential new therapies for the patients that need them."