On April 29, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the first quarter ended March 31, 2021 and raised 2021 guidance (Press release, LabCorp, APR 29, 2021, View Source [SID1234578816]).

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"We delivered very strong results in the first quarter driven by revenue growth across both our Diagnostics and Drug Development businesses," said Adam H. Schechter, chairman and CEO, Labcorp. "Overall revenue in our base business grew 14.6% as people continued to return to their pre-pandemic healthcare routines and our biopharmaceutical clients resumed their important research and development. Our drug development pipeline remained robust, with a book-to-bill of 1.47 on a trailing twelve-month basis driven by strong demand across major therapeutic areas."

In the quarter, Labcorp continued to bring science and technology innovations to market quickly to improve health and improve lives. The company opened a fully automated kit production facility in Belgium to support its Central Lab customers, ultimately improving access and cost efficiency for biopharma and clinical trial clients across Europe, the Middle East and Africa. In the fight against COVID-19, Labcorp expanded its work with the CDC to identify variants to the virus, and now offers Pixel by Labcorp COVID-19 home collection kits in thousands of pharmacies across the United States.

"We are pleased with our strong first quarter performance and improved outlook, and are raising our full year adjusted EPS guidance range to between $20.00 and $24.00. I am proud of our more than 70,000 employees and their commitment to our patients and customers during this pandemic and the difference they are making in the lives of people around the world," said Schechter.

Consolidated Results

First Quarter Results
Revenue for the quarter was $4.16 billion, an increase of 47.4% over $2.82 billion in the first quarter of 2020. The increase in revenue was due to organic growth of 45.0%, acquisitions of 0.9%, and favorable foreign currency translation of 1.4%. The 45.0% increase in organic revenue includes a 32.9% contribution from PCR and antibody testing (COVID-19 Testing) and a 12.2% increase in the company’s organic Base Business. Base Business includes Labcorp’s business operations except for COVID-19 Testing.

Operating income for the quarter was $1,057.9 million, or 25.4% of revenue, compared to ($192.6) million, or (6.8%), in the first quarter of 2020. The increase in operating income and margin was primarily due to COVID-19 Testing, organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs. The company recorded amortization, restructuring charges, and special items, which together totaled $124.0 million in the quarter, compared to $558.5 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $1,181.9 million, or 28.4% of revenue, compared to $365.9 million, or 12.9%, in the first quarter of 2020.

Net earnings (losses) for the quarter were $769.6 million, compared to ($317.2) million in the first quarter of 2020. Diluted EPS were $7.82 in the quarter, up from ($3.27) in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $8.79 in the quarter, up from $2.37 in the first quarter of 2020.

Operating cash flow for the quarter was $1,157.6 million, compared to $203.8 million in the first quarter of 2020. The increase in operating cash flow was due to higher cash earnings and lower working capital. Capital expenditures totaled $95.4 million, down from $106.6 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $1,062.2 million, up from $97.2 million in the first quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $1.9 billion and $5.4 billion, respectively. During the quarter, the company invested $34.1 million on acquisitions, repurchased $68.5 million of stock representing approximately 0.3 million shares, and paid down $375.0 million of debt. As of March 31, 2021, the company had $731.5 million of authorization remaining under its share repurchase program.
3

First Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics
Revenue for the quarter was $2.76 billion, an increase of 62.0% over $1.70 billion in the first quarter of 2020. The increase in revenue was primarily due to organic growth of 60.8%, acquisitions of 0.9%, and favorable foreign currency translation of 0.4%. The increase in organic revenue was due to a 54.5% contribution from COVID-19 Testing and a 6.3% increase in the Base Business, which includes the unfavorable impact of weather of approximately (2.0%).

Total volume (measured by requisitions) increased by 27.3% as organic volume increased by 26.6% and acquisition volume contributed 0.7%. The organic volume growth was due to a 27.9% contribution from COVID-19 Testing demand, partially offset by a (1.3%) reduction in organic Base Business, which includes the unfavorable impact from weather of approximately (2.0%). Price / mix increased by 34.7% primarily due to COVID-19 Testing of 26.6% and organic Base Business of 7.5%.

Adjusted operating income for the quarter was $991.6 million, or 36.0% of revenue, compared to $254.2 million, or 14.9%, in the first quarter of 2020. The increase in adjusted operating income and adjusted operating margin were primarily due to the increase in COVID-19 Testing, organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development
Revenue for the quarter was $1.44 billion, an increase of 25.7% over $1.14 billion in the first quarter of 2020. The increase in revenue was due to organic growth of 21.9%, acquisitions of 1.0%, and favorable foreign currency translation of 2.9%. The increase in organic revenue was due to a 19.7% increase in the Base Business and a 2.2% contribution from COVID-19 Testing performed through its Central Laboratories business. Drug Development benefited from broad-based demand across businesses, including COVID-19 vaccine and therapeutic work.

4

Adjusted operating income for the quarter was $234.1 million, or 16.3% of revenue, compared to $150.8 million, or 13.2%, in the first quarter of 2020. The increase in adjusted operating income and adjusted operating margin were primarily due to organic Base Business growth, COVID-19 Testing, and LaunchPad savings, partially offset by higher personnel costs. The company continues to develop and execute new LaunchPad programs to support profitable growth in Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $7.61 billion and 1.47, respectively. Backlog at the end of the quarter was $13.97 billion, compared to $13.76 billion last quarter, and the company expects approximately $4.62 billion of its backlog to convert into revenue in the next twelve months.

5

Outlook for 2021

Labcorp is raising its 2021 full year guidance to reflect the improved recovery in the Diagnostics and Drug Development base businesses, while the COVID-19 Testing contribution remains within the original guidance range provided. The following guidance assumes foreign exchange rates effective as of March 31, 2021 for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(Dollars in billions, except per share data) Previous Updated Results 2021 Guidance 2021 Guidance 2020 Low High Low High Revenue
Total Labcorp Enterprise (1)(2)
$ 13.98 (1.0%) 4.5% 2.0% 6.5%
Base Business (2)
$ 11.19 11.0% 13.5% 13.5% 16.0%
COVID-19 Testing (2)
$ 2.78 (50.0%) (35.0%) (50.0%) (35.0%)
Total Diagnostics (3)
$ 9.25 (7.5%) (0.5%) (5.0%) 0.0% Base Business $ 6.47 11.0% 14.0% 13.5% 16.0% COVID-19 Testing $ 2.78 (50.0%) (35.0%) (50.0%) (35.0%)
Total Drug Development (4)
$ 4.88 8.0% 10.5% 12.0% 14.0% Base Business $ 4.76 9.5% 12.0% 14.0% 16.0% Adjusted EPS $ 23.94 $ 19.00 $ 23.00 $ 20.00 $ 24.00
Free Cash Flow (5)
$ 1.75 $ 1.70 $ 1.90 $ 1.80 $ 2.00 (1) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.7%, Previous 2021 Guidance was 0.9% (2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue (3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.3%, Previous 2021 Guidance was 0.1% (4) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.4%, Previous 2021 Guidance was 2.2% (5) Free Cash Flow consists of operating cash flow less capital expenditures

6Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-898-8036 (720-634-2811 for international callers). The conference ID is 6566853. A telephone replay of the call will be available through May 13, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 6566853. A live online broadcast of Labcorp’s quarterly conference call on April 29, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through April 15, 2022.

On April 29, 2021 Hexagon reported that Interim Report 1 January – 31 March 2021 (Press release, Hexagon Bio, APR 29, 2021, View Source;31-march-2021-301280107.html [SID1234578853]).

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First quarter 2021

Net sales increased by 10 per cent to 977.9 MEUR (889.9). Using fixed exchange rates and a comparable group structure (organic growth), net sales increased by 11 per cent
Adjusted operating earnings (EBIT1) increased by 34 per cent to 257.9 MEUR (192.4)
Earnings before taxes, excluding adjustments, amounted to 250.3 MEUR (186.6)
Net earnings, excluding adjustments, amounted to 205.2 MEUR (153.0)
Earnings per share, excluding adjustments, amounted to 0.56 EUR (0.41)
Operating cash flow increased to 211.9 MEUR (136.9)
For further information please contact:

Maria Luthström, Head of Sustainability and Investor Relations, Hexagon AB, +46 8 601 26 27, [email protected]

This information is information that Hexagon AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CET on 29 April 2021.

This information was brought to you by Cision View Source

View Source;31-march-2021,c3336589

On April 29, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported business highlights and financial results for the first quarter ended March 31, 2021.

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"With the recent closing of the sale of our oncology business, we are excited to embrace a focused future in genetically defined diseases," said Jackie Fouse, Ph.D., chief executive officer at Agios. "In the weeks and months ahead, we look forward to a number of important catalysts, beginning with presentations at the EHA (Free EHA Whitepaper) 2021 Virtual Congress, where we will share data from our ACTIVATE and ACTIVATE-T studies of mitapivat in adults with pyruvate kinase (PK) deficiency, as well as data from our Phase 2 study of mitapivat in thalassemia. The PK deficiency data will form the basis of our upcoming submissions for regulatory approval in the U.S. this quarter and in the EU mid-year. Additionally, we look forward to further exploring the impact of mitapivat in thalassemia and sickle cell disease as we launch two Phase 3 studies and a Phase 2/3 study, respectively, later this year. The courage and needs of the patients and families that we seek to serve continue to be our great motivation, and we are proud of our recent educational and patient-focused efforts that aim to make a meaningful impact on rare hemolytic anemia communities."

FIRST QUARTER 2021 & RECENT HIGHLIGHTS
Closed the sale of commercial, clinical and research-stage oncology portfolio to Servier Pharmaceuticals, LLC, on March 31, 2021.

Initiated the repurchase of up to $1.2 billion of outstanding shares, as authorized by the board of directors, and entered into a definitive agreement with Bristol-Myers Squibb Company (BMS) to repurchase 7,121,658 shares of Agios common stock held by BMS and its affiliates for an aggregate purchase price of $344.5 million, or $48.38 per share. Agios expects to execute a meaningful portion of the planned repurchases by year-end through a combination of 10b5-1 plans and open market purchases.

Supported several educational and patient-focused initiatives, including the sponsorship of a health literacy program for sickle cell disease and the launch of a collaboration with 23andMe that led to addition of the very first PK deficiency carrier status report.

KEY UPCOMING MILESTONES

Finalize global regulatory filings for mitapivat in adults with PK deficiency; submit new drug application (NDA) in the U.S. in the second quarter of 2021 and marketing authorization application (MAA) in the EU in mid-2021.
Initiate two Phase 3 studies of mitapivat, ENERGIZE and ENERGIZE-T, in not regularly transfused and regularly transfused adults with thalassemia in the second half of 2021.
Initiate Phase 2/3 study of mitapivat in sickle cell disease by year-end.
Prioritize new indications for pyruvate kinase R (PKR) and pyruvate kinase M2 (PKM2) activator clinical development by year-end.

Data Presentations
Present data from the following clinical studies for presentation at the EHA (Free EHA Whitepaper) Virtual Congress, hosted June 9-17, 2021:
Phase 3 ACTIVATE study of mitapivat in adults with PK deficiency who do not receive regular transfusions
Phase 3 ACTIVATE-T study of mitapivat in adults with PK deficiency who receive regular transfusions
Phase 2 study of mitapivat in adults with α- and β-thalassemia who do not receive regular transfusions
Submit data from ongoing clinical studies of mitapivat in sickle cell disease for presentation at medical meetings in 2021.
Present data from the Phase 1 study of AG-946, the company’s next-generation PKR activator, in healthy volunteers by year-end.

FIRST QUARTER 2021 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for continuing operations were $57.7 million for the first quarter of 2021 compared to $55.4 million for the first quarter of 2020. The year-over-year increase in R&D was driven primarily by start-up costs associated with the Phase 3 studies of mitapivat in thalassemia and sickle cell disease.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for continuing operations were $33.6 million for the first quarter of 2021 compared to $31.7 million for the first quarter of 2020. The year-over-year increase in SG&A expenses was primarily attributable to one-time workforce expense.

Discontinued Operations: Due to the sale of the oncology business during the first quarter of 2021, we have reclassified the results of the oncology business as discontinued operations, including total revenue of $41.4 million, TIBSOVO net sales of $37 million, and operating expenses of $50.2 million related to discontinued operations.
Net Income: Net income was $1.9 billion for the first quarter of 2021 compared to a net loss of $40.3 million for the first quarter of 2020.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of March 31, 2021 were $2.4 billion compared to $613.1 million as of March 31, 2020. The company expects that its cash, cash equivalents and marketable securities as of March 31, 2021, together with anticipated interest income, future product sales and TIBSOVO royalties, will enable the company to fund its planned operating expenses and capital expenditure requirements through major catalysts and to cash-flow positivity without the need to raise additional equity.

CONFERENCE CALL INFORMATION

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss first quarter 2021 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 4497151. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On April 29, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported an oral presentation on RBN-2397 at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 4 to 8, 2021 (Press release, Ribon Therapeutics, APR 29, 2021, View Source [SID1234578799]). The full meeting program is available at: www.asco.org.

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Abstract Title: A first-in-human phase 1 study of a novel PARP7 inhibitor RBN-2397 in patients with advanced solid tumors
Session Date & Time: Friday, June 4, 2021 at 11:00 AM ET
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract ID: 3000

About RBN-2397

RBN-2397, is an orally available small molecule inhibitor of PARP7 that we are developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors. PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.

On April 29, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has filed an action in the General Court of the European Union asking for annulment of the European Commission’s decision asserting jurisdiction to review Illumina’s acquisition of GRAIL (Press release, Illumina, APR 29, 2021, View Source [SID1234578837]). The Commission asserted jurisdiction to review the acquisition under Article 22 of the EU Merger Regulation on April 19, 2021, seven months after the deal was announced.

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"The European Commission’s unprecedented and untimely decision to review this procompetitive acquisition without proper engagement with the parties leaves businesses uncertain as to how the EU Merger Regulation will be applied," said Charles Dadswell, Senior Vice President and General Counsel for Illumina. "The Commission’s actions will stifle innovation, fail patients and increase healthcare costs by needlessly delaying this transaction. The acquisition will allow Illumina to bring GRAIL’s lifesaving testing to more patients, more quickly and at a lower cost."

While the Court process is ongoing, Illumina will continue to work with the European Commission’s Directorate-General for Competition to bring the review to a conclusion as quickly as possible.