Acceleron Announces Presentations on REBLOZYL® (luspatercept-aamt) at the 2020 American Society of Clinical Oncology and European Hematology Association Virtual Annual Meetings

On May 20, 2020 Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported that a total of six distinct abstracts on REBLOZYL (luspatercept-aamt) will be presented at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, held May 29-31, and at the 25th Annual European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25) Virtual Congress, held June 11-21 (Press release, Acceleron Pharma, MAY 20, 2020, View Source [SID1234558338]).

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Poster Presentations at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program

Title: Longer-Term RBC Transfusion Reduction in the Phase 3 MEDALIST Study of Luspatercept in Patients (Pts) With Lower-Risk myelodysplastic syndromes (MDS) with Ring Sideroblasts (RS) – Abstract: #7518

Session:

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Title: Clinical Benefit of Luspatercept in Patients (Pts) With Lower-Risk MDS (LR-MDS) and High Transfusion Burden in the Phase 3 MEDALIST Study – Abstract: #7554

Session:

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Poster presentations and poster discussions will be available on demand through the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on May 29, 2020, at 8:00 a.m. EDT.

Presentations at EHA (Free EHA Whitepaper)25 Virtual Congress

Title: Assessment of Response to Luspatercept by β-Globin Genotype in Adult Patients With β-Thalassemia in the BELIEVE Trial – Abstract: Oral presentation S295

Title: Assessment of Longer-Term Efficacy and Safety in the Phase 3 BELIEVE Trial of Luspatercept to Treat Anemia in Patients (Pts) with β-Thalassemia – Abstract: e-Poster 1548

Title: Assessment of Dose-Dependent Response to Luspatercept in Patients (Pts) With Lower-Risk Myelodysplastic Syndromes (LR-MDS) With Ring Sideroblasts in the Phase 3 MEDALIST Trial – Abstract: e-Poster 812

Title: Effects of Luspatercept on Serum Ferritin in Patients (Pts) With Lower-Risk Myelodysplastic Syndromes (MDS) With Ring Sideroblasts (RS) in the Phase 3 MEDALIST Trial – Abstract: e-Poster 807

Title: Longer-Term RBC Transfusion Reduction in the Phase 3 MEDALIST Study of Luspatercept in Patients (Pts) With Lower-Risk myelodysplastic syndromes (MDS) with Ring Sideroblasts (RS) – Abstract: e-Poster 813

Title: Clinical Benefit of Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) and High Transfusion Burden (HTB) in the Phase 3 MEDALIST Study – Abstract: e-Poster 798

All e-Poster and oral abstract presentations will be made available on the on-demand EHA (Free EHA Whitepaper)25 Virtual Congress Platform beginning on June 12, 2020 at 8:30 a.m. CEST.

About REBLOZYL (luspatercept-aamt)

REBLOZYL is the first and only U.S. Food and Drug Administration-approved erythroid maturation agent designed to promote red blood cell production through a novel mechanism. Luspatercept-aamt is being developed to treat anemia in patients with beta-thalassemia, MDS, and myelofibrosis. REBLOZYL is part of the global collaboration between Acceleron and Bristol Myers Squibb.

McKesson Reports Fiscal 2020 Fourth-Quarter and Full-Year Results

On May 20, 2020 McKesson Corporation (NYSE:MCK) reported results for the fourth quarter and fiscal year ended March 31, 2020 (Press release, McKesson, MAY 20, 2020, View Source [SID1234558337]).

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"McKesson delivered a strong finish to fiscal 2020, reflecting continued momentum in the business and meaningful progress in our transformation towards becoming a more focused organization as we look to capture future growth opportunities," said Brian Tyler, chief executive offer. "During fiscal 2020, we achieved adjusted operating profit growth in all three operating segments, generated $3.9 billion of free cash flow, and successfully completed the exit of our investment in Change Healthcare."

"As we enter fiscal 2021, McKesson is leveraging our expertise, leadership and scale to play a critical role in the fight against the COVID-19 pandemic," Mr. Tyler continued. "We continue to remain focused on supporting our people, our customers and our communities during this challenging time. I want to thank caregivers worldwide for their heroic efforts and acknowledge the entire McKesson team, particularly our frontline workers, for their extraordinary dedication. Despite the uncertainties in the near-term macro environment, we remain confident in the resiliency of our business model and committed to creating long-term shareholder value."

Fourth-quarter revenues were $58.5 billion, up 12%, and full-year revenues were $231.1 billion, up 8%, driven by growth in the U.S. Pharmaceutical and Specialty Solutions segment, largely due to branded pharmaceutical price increases and higher volumes from retail national account customers.

Fourth-quarter earnings per diluted share of $5.82 included an after-tax gain of $414 million, recognized upon the separation of the company’s investment in Change Healthcare LLC ("Change Healthcare"). Full-year earnings per diluted share of $4.99 also included after-tax impairment and dilution charges of $1 billion related to Change Healthcare and after-tax charges of $275 million within our European Pharmaceutical Solutions segment for the remeasurement to fair value of assets and liabilities held for sale related to the expected formation of a new German wholesale joint venture with Walgreens Boots Alliance.

Fourth-quarter Adjusted Earnings per diluted share was $4.27 compared to $3.69 a year ago, an increase of 16%, primarily driven by a lower share count and growth in the European Pharmaceutical Solutions segment. Full-year Adjusted Earnings per diluted share was $14.95 compared to $13.57 a year ago, an increase of 10%, primarily driven by a lower share count and growth in the U.S. Pharmaceutical and Specialty Solutions and Medical Surgical segments, partially offset by higher corporate expenses and the lapping of a prior year pre-tax benefit of $90 million related to a reversal of a contractual liability associated with McKesson’s investment in Change Healthcare.

For the full year, McKesson returned $2.2 billion of cash to shareholders via $1.9 billion of common stock repurchases and $294 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.4 billion, and invested $506 million internally, resulting in free cash flow of $3.9 billion.

U.S. Pharmaceutical and Specialty Solutions Segment

Fourth-Quarter:

Revenues were $46.3 billion, up 13%, driven by branded pharmaceutical price increases and higher volumes from retail national account customers, partially offset by branded to generic conversions.
Operating profit was $862 million and operating margin was 1.86%. Adjusted operating profit was $772 million, up 3% from a year ago, driven by continued growth in the specialty businesses. Adjusted operating margin was 1.67%, down 17 basis points.
Full-Year:

Revenues were $183.3 billion, up 9%, driven by branded pharmaceutical price increases and higher volumes from retail national account customers, partially offset by branded to generic conversions.
Operating profit was $2.8 billion and operating margin was 1.51%. Adjusted operating profit was $2.7 billion, up 6% from a year ago, driven by growth in the specialty businesses and the lapping of a prior year approximately $60 million pre-tax charge related to a customer bankruptcy. Adjusted operating margin was 1.46%, down 4 basis points.
European Pharmaceutical Solutions Segment

Fourth-Quarter:

Revenues were $7.2 billion, up 6% on a reported basis and up 9% on an FX-adjusted basis, driven by growth in the pharmaceutical distribution business.
Operating profit was $36 million and operating margin was 0.50%. Adjusted operating profit was $75 million, up 226%, and adjusted operating margin was 1.05%. On an FX-adjusted basis, adjusted operating profit was $78 million, up 239%, and adjusted operating margin was 1.06%, up 72 basis points, driven by expense rationalization and the lapping of a prior year inventory charge of approximately $20 million.
Full-Year:

Revenues were $27.4 billion, up 1% on a reported basis and up 5% on an FX-adjusted basis, driven by growth in the pharmaceutical distribution business.
Operating loss was ($261) million and operating margin was (0.95%), driven by after-tax charges of $275 million for the remeasurement to fair value of assets and liabilities held for sale related to the expected formation of a new German wholesale joint venture with Walgreens Boots Alliance. Adjusted operating profit was $231 million, up 5%, and adjusted operating margin was 0.84%. On an FX-adjusted basis, adjusted operating profit was $240 million, up 10%, and adjusted operating margin was 0.84%, driven by expense rationalization and the lapping of a prior year inventory charge of approximately $20 million.
Medical-Surgical Solutions Segment

Fourth-Quarter:

Revenues were $2.2 billion, up 13%, driven by growth in the Primary Care business, due to higher pharmaceutical volumes and a stronger influenza season.
Operating profit was $121 million and operating margin was 5.49%. Adjusted operating profit was $170 million, down 1%, driven primarily by higher operating expenses, partially offset by growth in the Primary Care business. Adjusted operating margin was 7.71%, down 109 basis points.
Full-Year:

Revenues were $8.3 billion, up 9%, driven by growth in the Primary Care business.
Operating profit was $499 million and operating margin was 6.01%. Adjusted operating profit was $679 million, up 12%, and adjusted operating margin was 8.18%, up 24 basis points, driven by growth in the Primary Care business.
Other remaining businesses

Fourth-Quarter:

Revenues were $2.9 billion, up 3% on a reported basis and up 4% on an FX-adjusted basis, driven by growth in the Canadian and MRxTS businesses.
Operating profit was $514 million, driven by an after-tax gain of $414 million, recognized upon the separation of the company’s investment in Change Healthcare. Adjusted operating profit was $242 million, down 6% on both a reported and FX-adjusted basis, driven by a lower contribution from the company’s investment in Change Healthcare, partially offset by growth in the MRxTS business.
Full-Year:

Revenues were $12.0 billion, up 3% on a reported basis and up 4% on an FX-adjusted basis, driven by growth in the Canadian and MRxTS businesses.
Operating loss was ($595) million, primarily driven by a previously disclosed impairment in the second quarter, in connection with McKesson’s separation of its investment in Change Healthcare. Adjusted operating profit was $953 million, down 4% on both a reported and FX-adjusted basis, driven by the lapping of the $90 million contractual liability reversal in the prior year partially offset by organic growth in the MRxTS and Canadian businesses.
Company Updates

On March 10, 2020, McKesson completed the separation of its investment in Change Healthcare.
McKesson awarded approximately $30 million in special one-time bonus payments in the fourth-quarter to recognize frontline workers and other non-bonus eligible employees for their contributions.
McKesson invested approximately $20 million into the McKesson Foundation in the fourth-quarter, designating $5 million for deployment to McKesson’s "Taking Care of Our Own Fund" to provide support for employees impacted by the COVID-19 pandemic.
Fiscal 2021 Outlook

McKesson expects full-year fiscal 2021 Adjusted Earnings per diluted share of $13.95 to $14.75, which reflects anticipated headwinds in fiscal 2021 as a result of the COVID-19 pandemic and a continuation of disciplined, efficient capital deployment, including investments in the business. McKesson expects 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, Wednesday, May 20th 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 The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’. A telephonic replay of this conference call will be available for 14 calendar days. For individuals wishing to listen to the replay, the dial-in number is 404-537-3406 and the passcode is 6206708. 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:

Jefferies Virtual Healthcare Conference, June 2, 2020
Goldman Sachs 41st Annual Global Healthcare Conference, June 9, 2020
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, including details and updates, will be available on the company’s Investor Relations website.

Oncternal Therapeutics Announces $5.0 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

On May 20, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 1,943,636 shares of its common stock, at a purchase price of $2.5725 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Oncternal Therapeutics, MAY 20, 2020, View Source [SID1234558330]). Oncternal has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 971,818 shares of its common stock. The closing of the offering is expected to occur on or about May 21, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $2.51 per share, will be exercisable immediately upon issuance and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering are expected to be approximately $5.0 million, before deducting placement agent’s fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical development of cirmtuzumab and TK216, preclinical development of our ROR1 CAR-T program and other preclinical programs, and for working capital.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

BeiGene to Present at the Bernstein 36th Annual Strategic Decisions Conference

On May 20, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the Company will present at the Bernstein 36th Annual Strategic Decisions Conference on Wednesday, May 27, 2020 at 8:00 a.m. ET (Press release, BeiGene, MAY 20, 2020, View Source/news-releases/news-release-details/beigene-present-bernstein-36th-annual-strategic-decisions" target="_blank" title="View Source/news-releases/news-release-details/beigene-present-bernstein-36th-annual-strategic-decisions" rel="nofollow">View Source [SID1234558329]).

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A live webcast can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available following the event for 90 days.

Sales of darolutamide started in the EU and Japan – Orion receives total of EUR 28 million milestones

On May 20, 2020 Orion Corporation and Bayer reported Sales of Nubeqa (darolutamide), jointly developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), has started in the EU and Japan (Press release, Orion , MAY 20, 2020, View Source [SID1234558328]). From the first commercial sales in the EU Orion receives from Bayer a EUR 20 million and from the first commercial sales in Japan a EUR 8 million milestone. Orion will book the milestones in its second quarter 2020 result. The booking has no impact on Orion’s outlook for 2020 as the total of EUR 28 million milestones have been included in the financial guidance provided by the company.

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