argenx to Present at the 11th Annual SVB Leerink Global Healthcare Conference

On February 10, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that members of management will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on Thursday, February 17, 2022 at 10:40 a.m. ET (Press release, argenx, FEB 10, 2022, View Source [SID1234607989]).

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A live webcast of the presentation may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately 90 days following the presentation.

Genocea to Present at the 11th Annual SVB Leerink Global Healthcare Conference

On February 10, 2022 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that Chip Clark, President and Chief Executive Officer, will present a corporate overview at the virtual 11th Annual SVB Leerink Global Healthcare Conference on Thursday, February 17th at 10:40 A.M. ET (Press release, Genocea Biosciences, FEB 10, 2022, View Source [SID1234607988]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available in the "Events and Presentations" tab of the investor relations section of the Genocea website at View Source A replay of the webcast will be archived for 90 days following the presentation.

Kura Oncology to Participate in SVB Leerink Global Healthcare Conference

On February 10, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the 11th Annual SVB Leerink Global Healthcare Conference (Press release, Kura Oncology, FEB 10, 2022, View Source [SID1234607986]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at 12:40 p.m. PT / 3:40 p.m. ET on Thursday, February 17, 2022.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.

Labcorp Announces 2021 Fourth Quarter and Full-Year Results

On February 10, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the fourth quarter and year ended Dec. 31, 2021, full-year 2022 guidance and longer-term outlook (Press release, LabCorp, FEB 10, 2022, View Source [SID1234607985]).

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"Labcorp’s ability to harness science, innovation and technology helped us advance our strategy, effectively respond to the global pandemic, and drive meaningful financial performance throughout 2021," said Adam Schechter, chairman and CEO of Labcorp. "We experienced Base Business growth of 8.2% in the fourth quarter and 19.4% in 2021. This provides significant momentum and sets the stage for continued Base Business growth in 2022 and beyond."

In the fourth quarter and throughout the year, Labcorp made important contributions to the ongoing pandemic response while growing its core business.

The company furthered its efforts to advance cancer testing and the development of innovative treatments, including through the pending acquisition of Personal Genome Diagnostics, a leading provider of comprehensive liquid biopsy and tissue-based genomic products and services. Labcorp expanded on its solid record of pursuing high-growth opportunities and leveraging its unique diagnostics and drug development capabilities. By entering into a long-term relationship with Ascension, one of the nation’s largest health systems, the company expects to broaden access to its clinical laboratory services in 10 states. Labcorp will also acquire select assets of the health system’s outreach laboratory. The company expects first year annualized revenues to be between $550 million and $600 million. The transaction is expected to be accretive to the company’s earnings in year one and return its cost of capital by year two.

In December, Labcorp announced several actions to further enhance shareholder value following the conclusion of the company’s previously announced, comprehensive review of its structure and capital allocation strategy. The actions include the initiation of a dividend in the second quarter of 2022, the authorization of a $2.5 billion share repurchase program, of which $1.0 billion is being repurchased through an accelerated plan, and the implementation of a new LaunchPad business process improvement initiative that targets $350 million in savings over the next three years. The Board also unanimously concluded that the company’s existing structure is in the best interest of shareholders at this time. The Labcorp management team and Board are committed to continuing to evaluate all avenues for enhancing shareholder value.

Consolidated Results

Fourth Quarter Results

Revenue for the quarter was $4.06 billion, a decrease of (9.7%) from $4.49 billion in the fourth quarter of 2020. The decrease was due to organic revenue of (10.3%) and divestitures of (0.1%), partially offset by acquisitions of 0.6% and foreign currency translation of 0.1%. The (10.3%) decline in organic revenue was driven by a (15.3%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 5.0% increase in the company’s organic Base Business. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $730.6 million, or 18.0% of revenue, compared to $1,293.2 million, or 28.8%, in the fourth quarter of 2020. The company recorded amortization, restructuring charges, and special items, which together totaled $171.5 million in the quarter, compared to $136.3 million during the same period in 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $902.2 million, or 22.2% of revenue, compared to $1,429.5 million, or 31.8%, in the fourth quarter of 2020. The decrease in operating income and margin was due to a reduction in COVID-19 Testing.

Net earnings for the quarter were $553.0 million compared to $938.3 million in the fourth quarter of 2020. Diluted EPS were $5.75 in the quarter compared to $9.54 during the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $6.77 in the quarter compared to $10.56 in the fourth quarter of 2020.

Operating cash flow for the quarter was $697.5 million compared to $774.6 million in the fourth quarter of 2020. The decrease in operating cash flow was due to lower cash earnings, partially offset by favorable working capital. Capital expenditures totaled $150.0 million compared to $99.4 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $547.5 million compared to $675.2 million in the fourth quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $1.5 billion and $5.4 billion, respectively. During the quarter, the company invested $170.9 million on acquisitions and executed an accelerated stock repurchase program totaling $1.0 billion. As a result of the accelerated stock repurchase program, the company purchased approximately 2.7 million shares at inception, and a final share settlement will occur on or before April 29, 2022.

Full Year Results

Revenue was $16.12 billion, an increase of 15.3% from $13.98 billion in 2020. The increase was due to organic growth of 13.8%, acquisitions of 0.7%, and foreign currency translation of 0.9%, partially offset by divestitures of (0.1%). The organic revenue increase includes a 14.0% contribution from the company’s organic Base Business and a (0.2%) decrease in COVID-19 Testing.

Operating income was $3.26 billion, or 20.2% of revenue, compared to $2.45 billion, or 17.5%, in 2020. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $571.5 million compared to $886.5 million during 2020. This decrease was due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $3.83 billion, or 23.8% of revenue, compared to $3.33 billion, or 23.8%, in 2020. The increase in operating income was primarily due to a recovery in the Base Business, partially offset by a decrease in COVID-19 Testing.

Net earnings were $2.38 billion compared to $1.56 billion in 2020. Diluted EPS were $24.39 compared to $15.88 in 2020. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $28.52 compared to $23.94 in 2020.

Operating cash flow was $3.11 billion compared to $2.14 billion in 2020. The increase in operating cash flow was due to favorable working capital. Capital expenditures totaled $460.4 million compared to $381.7 million in 2020. As a result, free cash flow (operating cash flow less capital expenditures) was $2.65 billion compared to $1.75 billion in 2020.

During the year the company repurchased $1,668.5 million of stock representing approximately 5.2 million shares, invested $496.9 million on acquisitions, and paid down $375.0 million of debt.

Fourth Quarter Segment Results

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

Diagnostics

Revenue for the quarter was $2.62 billion, a decrease of (16.9%) from $3.15 billion in the fourth quarter of 2020. The decrease was due to organic revenue of (17.8%), partially offset by acquisitions of 0.7% and foreign currency translation of 0.2%. The decrease in organic revenue was due to a (21.8%) reduction in COVID-19 Testing, partially offset by a 4.1% increase in the Base Business.

Total volume (measured by requisitions) decreased by (8.7%) as organic volume decreased by (8.9%), partially offset by acquisition volume of 0.3%. Organic volume was impacted by a (14.6%) decrease in COVID-19 Testing, partially offset by a 5.7% increase in Base Business. Price/mix decreased by (8.2%) due to COVID-19 Testing of (7.2%) and Base Business of (1.6%), partially offset by acquisitions of 0.5%, and currency of 0.2%. Organic Base Business volume was up 8.1% compared to the Base Business last year, while price/mix was down (1.0%).

Adjusted operating income for the quarter was $775.9 million, or 29.6% of revenue, compared to $1,234.4 million, or 39.1%, in the fourth quarter of 2020. Adjusted operating income and margin declined due to a reduction in COVID-19 Testing. Base Business adjusted operating income and margin were up due to increased demand and LaunchPad savings, partially offset by higher personnel costs. The company achieved its goal 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 $1.45 billion, an increase of 3.9% from $1.40 billion in the fourth quarter of 2020. The increase was due to organic Base Business growth of 7.9% and acquisitions of 0.3%, partially offset by lower COVID-19 Testing performed through its Central Laboratories business of (4.0%) and divestitures of (0.3%).

Adjusted operating income for the quarter was $205.7 million, or 14.2% of revenue, compared to $248.4 million, or 17.8%, in the fourth quarter of 2020. Adjusted operating income and margin declined primarily due to lower COVID-19 Testing. In the Base Business, higher personnel and other inflationary costs were partially offset by organic growth and LaunchPad savings. Drug Development excludes expense related to the Enterprise component of its bonus, which is included in unallocated corporate expense.

Net orders and net book-to-bill during the trailing twelve months were $7.28 billion and 1.25, respectively. Backlog at the end of the quarter was $14.96 billion, an increase of 8.7% compared to last year. The company expects approximately $5.01 billion of its backlog to convert into revenue in the next twelve months.

2022 Guidance

The following guidance assumes foreign exchange rates effective as of Dec. 31, 2021, for the full year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

Longer-Term Outlook (2022-2024)

The following outlook assumes foreign exchange rates effective as of Dec. 31, 2021. Enterprise level outlook includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

Tiziana Life Sciences CEO to Present at
Annual BIO CEO & Investor Conference

On February 10, 2022 Tiziana Life Sciences Ltd (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, reported that Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer, will be presenting at the upcoming 2022 BIO CEO & Investor Conference being held at the Marriott Marquis in NYC on February 14-15 and virtually through the 17th (Press release, Tiziana Life Sciences, FEB 10, 2022, View Source [SID1234607984]).

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Management will be available for 1×1 investor meetings on February 14-15. Register here to request a meeting with management.

Presentation Focus:

Tiziana is developing proprietary and novel formulation technologies to enable alternative routes of immunotherapy. Tiziana’s lead programs are focused on developing the fully-human antibody, foralumab via varied modes of delivery, alone or in combination to address different therapeutic indications. Data from clinical and animal studies support the underlying hypothesis that nasally administered foralumab acts via site-targeted immunomodulation. This concept was further validated by clinical data from a recently completed study with nasally administered foralumab in COVID-19 patients.

Further, interim data from a clinical study in a patient with secondary progressive multiple sclerosis (SPMS) also indicated that the treatment was not only well-tolerated, but it also produced clinical response after three months of treatment. Consequently, the Food and Drug Administration (FDA) reviewed the safety data and allowed continuation of dosing. Six-month treatment results in this patient will be reported in the first quarter of 2022.

A similar mechanism of site-targeted immunomodulation exists for orally administered foralumab for treatment of inflammatory bowel diseases (IBD) such as Crohn’s Disease and ulcerative colitis. Recently, Tiziana submitted an amended Investigational Drug Application (IND) for a Phase 1b study evaluating safety and tolerability of orally administered foralumab in patients with mild-to-moderate Crohn’s Disease. The study is expected to conclude in the fourth quarter of this year.