Kronos Bio and Gilead Sciences Enter Into Asset Purchase Agreement for Gilead’s SYK Inhibitor Portfolio

On July 16, 2020 Kronos Bio, Inc., a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics designed to transform patient outcomes by targeting dysregulated transcription, reported that it has entered into an asset purchase agreement with Gilead Sciences, Inc. to acquire Gilead’s spleen tyrosine kinase (SYK) inhibitor portfolio (Press release, Kronos Bio, JUL 16, 2020, View Source [SID1234561945]). The portfolio includes the clinical stage compounds entospletinib, which has been evaluated in Phase 1 and Phase 2 clinical trials in oncology patients, and lanraplenib, which has been evaluated in Phase 2 clinical trials in patients with autoimmune diseases.
"Kronos is uniquely positioned to advance these differentiated and selective SYK inhibitors by leveraging our expertise in oncology and transcriptional regulatory networks," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "We believe the acquisition of these compounds not only propels us more quickly into clinical development but also brings us closer to our goal of transforming patient outcomes."

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Kronos intends to initially focus on developing the SYK inhibitor program in a biomarker-defined subset of patients with acute myelogenous leukemia (AML). SYK is a critical node in AML overexpressing the HOXA9 and MEIS1 transcription factors. HOXA9 and MEIS1 become dysregulated as a result of recurring mutations found in up to one half of AML patients.

"Despite recent advancements in AML, there remains a substantial need for targeted therapies that can extend life," said John Byrd, M.D., D. Warren Brown Chair of Leukemia Research, and Distinguished University Professor of The Ohio State University Comprehensive Cancer Center and Chief Medical Officer of The Leukemia & Lymphoma Society Beat AML Trial. "SYK inhibition has demonstrated promising activity in clinical trials of AML patients who have high HOXA9/MEIS1 expression and is an optimal target for further clinical research to understand how HOXA9/MEIS1 dysregulation drives AML in these patients. The Beat AML Trial directed by The Leukemia & Lymphoma Society has partnered closely with Gilead and looks forward to continued close collaboration with Kronos Bio."

Entospletinib has produced promising early clinical data in a biomarker-defined subset of AML patients (Liu, et al. EHA (Free EHA Whitepaper) poster abstract PF246, 2018). Entospletinib has been investigated in over 500 patients across six Gilead sponsored studies in a variety of hematologic malignancies, including AML, demonstrating activity as a single-agent and in combination with standard-of-care.

Lanraplenib has been investigated in over 250 patients across seven Gilead sponsored studies in various autoimmune diseases. Its pharmaceutical properties may make it a commercially attractive next generation product candidate.

Under the terms of the agreement, Gilead will receive an upfront cash payment and a note convertible into Kronos equity, and will be eligible to receive regulatory and commercial milestones and royalties on future sales of products arising from the acquired programs.

Veracyte to Release Second Quarter 2020 Financial Results on July 30, 2020

On July 16, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the second quarter of 2020 after the close of market on Thursday, July 30, 2020 (Press release, Veracyte, JUL 16, 2020, View Source [SID1234561942]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 4:30 p.m. Eastern time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):


(855) 541-0980

International participant dial-in number:


(970) 315-0440

Conference I.D.:


2496566

Abbott Reports Second-Quarter 2020 Results, Exceeds Analysts’ Expectations

On July 16, 2020 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2020 (Press release, Abbott, JUL 16, 2020, View Source [SID1234561941]).

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Second-quarter worldwide sales of $7.3 billion decreased 8.2 percent on a reported basis and 5.4 percent on an organic basis, which excludes the impact of foreign exchange.
Reported diluted EPS from continuing operations under GAAP was $0.30 and adjusted diluted EPS from continuing operations, which excludes specified items, was $0.57 in the second quarter.
Abbott projects full-year 2020 diluted EPS from continuing operations on a GAAP basis of at least $2.00 and full-year adjusted diluted EPS from continuing operations of at least $3.25.
In April, Abbott announced CE Mark approval for its TriClip heart valve repair system, the world’s first minimally invasive, clip-based tricuspid heart valve repair device.
In June, Abbott announced U.S. FDA approval of FreeStyle Libre 2 as an integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes, achieving the highest level of accuracy and performance standards.1
Last week, Abbott announced U.S. FDA approval of its next-generation Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices to help manage heart rhythm disorders. These devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring and enhanced patient-physician engagement.
"Our diversified business model has proven to be a true strength during this time," said Robert B. Ford, president and chief executive officer, Abbott. "We’re a leader in the global COVID-19 testing efforts, we’ve continued to advance our pipeline and, importantly, we saw significant improvements in growth trends throughout the quarter in the business areas that were initially most impacted by the pandemic."

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the second quarter 2020:

* Total Q2 2020 Abbott sales from continuing operations include Other Sales of approximately $15 million.

* Total 1H 2020 Abbott sales from continuing operations include Other Sales of approximately $30 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2020 worldwide sales of $7.3 billion decreased 8.2 percent on a reported basis. On an organic basis, worldwide sales decreased 5.4 percent. First-half 2020 worldwide sales of $15.1 billion decreased 3.0 percent on a reported basis and 0.7 percent on an organic basis.

Worldwide Nutrition sales increased 0.4 percent on a reported basis and 3.1 percent on an organic basis in the second quarter. Strong U.S. and international sales performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, led to global Adult Nutrition sales growth of 7.4 percent on an organic basis. In Pediatric Nutrition, sales were led by U.S. growth of Pedialyte, Abbott’s oral rehydration brand, as well as growth in Southeast Asia, which were offset by challenging conditions in Greater China.

For the first half of 2020, worldwide Nutrition sales increased 3.3 percent on a reported basis and 5.1 percent on an organic basis, including organic sales growth of 3.0 percent in Pediatric Nutrition and 7.9 percent in Adult Nutrition.

Worldwide Diagnostics sales increased 4.7 percent on a reported basis in the second quarter, including an unfavorable 2.4 percent effect of foreign exchange, and increased 7.1 percent on an organic basis.

In Core Laboratory Diagnostics, lower routine diagnostics testing due to COVID-19 was partially offset by sales of Abbott’s COVID-19 laboratory-based tests for the detection of the IgG antibody, which determines if someone was previously infected with the virus. Core Laboratory IgG antibody testing-related sales on Abbott’s Architect and Alinity i platforms were $152 million in the quarter.

Molecular Diagnostics sales increased 233.6 percent on a reported basis and 241.4 percent on an organic basis in the second quarter. Strong growth was driven by demand for Abbott’s laboratory-based molecular tests for COVID-19 on its m2000 and Alinity m platforms. Molecular Diagnostics COVID-19 testing-related sales were $283 million in the quarter.

Rapid Diagnostics sales increased 9.6 percent on a reported basis and 11.0 percent on an organic basis in the second quarter. Lower base business sales were more than offset by strong demand for Abbott’s point-of-care COVID-19 molecular test on its ID NOW platform. Rapid Diagnostics COVID-19 testing-related sales were $180 million in the quarter.

Established Pharmaceuticals sales decreased 8.6 percent on a reported basis in the second quarter and decreased 0.7 percent on an organic basis. For the first half of 2020, Established Pharmaceuticals sales decreased 2.1 percent on a reported basis and increased 4.0 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 10.3 percent on a reported basis in the second quarter and decreased 0.4 percent on an organic basis. Sales growth in certain countries, including double-digit growth in China, was more than offset by lower demand due to the increased spread of COVID-19 across several emerging market countries, including Russia, Brazil and Colombia.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Worldwide Medical Devices sales decreased 21.2 percent on a reported basis in the second quarter and decreased 19.9 percent on an organic basis. Sales growth was negatively impacted by reduced cardiovascular and neuromodulation procedure volumes due to COVID-19. Procedure volume trends improved significantly over the course of the second quarter as both demand for procedures and availability of healthcare resources began to return to more normalized levels.

In Diabetes Care, strong growth was led by FreeStyle Libre, which grew 36.8 percent on a reported basis and 39.9 percent on an organic basis versus the prior year. In June, Abbott announced U.S. FDA approval of FreeStyle Libre 2 as an integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes, achieving the highest level of accuracy and performance standards.1 The FreeStyle Libre 2 system will be available in the coming weeks at participating pharmacies and durable medical equipment providers at the same price as the currently available FreeStyle Libre 14 day system.

ABBOTT’S GUIDANCE FOR 2020
Abbott projects full-year 2020 diluted earnings per share from continuing operations under GAAP of at least $2.00. Abbott forecasts specified items for the full-year 2020 of $1.25 primarily related to intangible amortization, acquisition-related expenses, restructuring and cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $3.25 for full-year 2020.

ABBOTT DECLARES 386TH CONSECUTIVE QUARTERLY DIVIDEND
On June 12, 2020, the board of directors of Abbott declared the company’s quarterly dividend of $0.36 per share. Abbott’s cash dividend is payable August 17, 2020, to shareholders of record at the close of business on July 15, 2020.

Abbott has increased its dividend payout for 48 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

Agios to Webcast Conference Call of Second Quarter 2020 Financial Results on July 30, 2020

On July 16, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, July 30, 2020 at 8:00 a.m. ET to report its second quarter 2020 financial results and other business highlights (Press release, Agios Pharmaceuticals, JUL 16, 2020, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-second-quarter-2020-financial [SID1234561940]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 2955575. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

Bristol Myers Squibb Announces Expiration and Final Results of Registered Exchange Offers

On July 16, 2020 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol Myers Squibb") reported the expiration and final results of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $19,000,000,000 aggregate principal amount of senior unsecured notes previously issued on May 16, 2019 ("May Notes") pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), and (ii) $18,545,623,000 aggregate principal amount of its outstanding senior unsecured notes previously issued on November 22, 2019 (the "November Notes" and, together with the May Notes, the "Original Notes") pursuant to an exemption from the registration requirements of the Securities Act, for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes") (Press release, Bristol-Myers Squibb, JUL 16, 2020, View Source [SID1234561939]).

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The Registered Exchange Offer expired at 5:00 p.m., New York City time, on July 15, 2020 (the "Expiration Date"). As of the Expiration Date, the aggregate principal amounts of Original Notes set forth in the table below had been validly tendered and not validly withdrawn. Bristol Myers Squibb has accepted for exchange all such tendered Original Notes in the Registered Exchange Offers.

Title of Series of Original Notes

Amount
Outstanding at
Commencement

Amount
Tendered as of the
Expiration Date

Percentage

2.875% Senior Notes due 2020

$1,243,777,000

$1,186,279,000

95.38%

3.950% Senior Notes due 2020

$436,313,000

$425,282,000

97.47%

Senior Floating Rate Notes due 2020

$750,000,000

$712,942,000

95.06%

2.875% Senior Notes due 2021

$434,815,000

$406,758,000

93.55%

2.250% Senior Notes due 2021

$464,576,000

$452,743,000

97.45%

2.550% Senior Notes due 2021

$1,000,000,000

$963,195,000

96.32%

3.250% Senior Notes due 2022

$861,709,000

$855,002,000

99.22%

3.550% Senior Notes due 2022

$891,870,000

$890,930,000

99.89%

Senior Floating Rate Notes due 2022

$500,000,000

$485,088,000

97.02%

2.600% Senior Notes due 2022

$1,500,000,000

$1,488,572,000

99.24%

2.750% Senior Notes due 2023

$697,660,000

$688,878,000

98.74%

3.250% Senior Notes due 2023

$932,101,000

$924,851,000

99.22%

4.000% Senior Notes due 2023

$636,086,000

$624,976,000

98.25%

3.625% Senior Notes due 2024

$882,510,000

$882,403,000

99.99%

2.900% Senior Notes due 2024

$3,250,000,000

$3,208,481,000

98.72%

3.875% Senior Notes due 2025

$2,379,532,000

$2,368,581,000

99.54%

3.200% Senior Notes due 2026

$2,250,000,000

$2,243,559,000

99.71%

3.450% Senior Notes due 2027

$961,528,000

$960,491,000

99.89%

3.900% Senior Notes due 2028

$1,456,162,000

$1,450,092,000

99.58%

3.400% Senior Notes due 2029

$4,000,000,000

$3,968,935,000

99.22%

4.125% Senior Notes due 2039

$2,000,000,000

$1,995,600,000

99.78%

5.700% Senior Notes due 2040

$245,785,000

$245,637,000

99.94%

5.250% Senior Notes due 2043

$391,925,000

$388,625,000

99.16%

4.625% Senior Notes due 2044

$976,477,000

$975,977,000

99.95%

5.000% Senior Notes due 2045

$1,959,524,000

$1,958,923,000

99.97%

4.350% Senior Notes due 2047

$1,236,433,000

$1,236,433,000

100.00%

4.550% Senior Notes due 2048

$1,456,840,000

$1,447,340,000

99.35%

4.250% Senior Notes due 2049

$3,750,000,000

$3,749,500,000

99.99%

Total

$37,545,623,000

$37,186,073,000

99.04%

Upon the settlement of the Registered Exchange Offers, holders of Original Notes who validly tendered and did not validly withdraw such notes prior to the Expiration Date will receive a like principal amount of Registered Notes of the applicable series. Bristol Myers Squibb expects that such settlement will occur on or about July 17, 2020.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the issuance of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. Bristol Myers Squibb will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes. The Registered Exchange Offers do not represent a new financing transaction.

A Registration Statement on Form S-4 (File No. 333-238533) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on May 20, 2020 and was declared effective on June 15, 2020. The Registered Exchange Offers were made pursuant to the terms and subject to the conditions set forth in a prospectus dated June 16, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement.

This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein.