On May 4, 2021 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the first quarter of fiscal year 2021 (Press release, Leidos, MAY 4, 2021, View Source [SID1234579104]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented: "First quarter results reflect the perseverance, focus and tremendous execution of our employees and business partners. New quarterly record levels of revenue, non-GAAP EPS and backlog were achieved, and significant organic growth was delivered across all business segments. This early momentum favorably positions Leidos to deliver on our full year financial commitments."

Summary Results

Revenues for the quarter were $3.32 billion, compared to $2.89 billion in the prior year quarter, reflecting a 14.7% increase. Excluding our revenue growth from our acquisitions of $168 million for Dynetics, Inc. ("Dynetics"), L3Harris Technologies’ security detection and automation businesses (the "SD&A Businesses") and 1901 Group, LLC ("1901 Group"), organic revenue increased by $258 million or 8.9%. This increase was primarily attributable to program wins and a net increase in volumes on certain programs.

Operating income for the quarter was $308 million, compared to $192 million in the prior year quarter, reflecting a 60.4% increase. Operating income margin increased to 9.3% from 6.6% in the prior year quarter. Non-GAAP operating income margin for the quarter was 11.1%, compared to 8.5% in the prior year quarter, primarily attributable to a net increase in higher margin program volumes, program wins and a $26 million net benefit from an adjustment to legal reserves related to the Mission Support Alliance joint venture.

Diluted earnings per share ("EPS") attributable to Leidos common stockholders for the quarter was $1.42, compared to $0.80 in the prior year quarter. Non-GAAP diluted EPS for the quarter was $1.73, compared to $1.19 in the prior year quarter. The weighted average diluted share count for the quarter was 144 million for both the current and prior year quarters.

Defense Solutions

Defense Solutions revenues for the quarter of $1,958 million increased by $253 million, or 14.8%, compared to the prior year quarter. The increase in revenues was primarily attributable to program wins, a net increase in volumes on certain programs and a benefit in exchange rate movements. The acquisition of Dynetics contributed incremental revenues of $83 million in the current quarter, which represents an additional month of revenues as compared to the prior year quarter and our acquisition of the 1901 Group contributed $13 million of revenues. The increases in revenues were partially offset by the completion of certain contracts.

Defense Solutions operating income margin for the quarter was 7.8%, compared to 5.6% in the prior year quarter. On a non-GAAP basis, operating income margin for the quarter was 9.2%, compared to 6.8% in the prior year quarter, primarily attributable to program wins, a net increase in program volumes on higher margin contracts and lower indirect expenditures.

Civil

Civil revenues for the quarter of $766 million increased by $112 million, or 17.1%, compared to the prior year quarter. The revenue increase was primarily attributable to $72 million of revenues related to the acquisition of the SD&A Businesses in the second quarter of fiscal 2020 and a net increase in program volumes.

Civil operating income margin for the quarter was 9.7%, compared to 9.0% in the prior year quarter. On a non-GAAP basis, operating income margin for the quarter was 12.0%, compared to 10.9% in the prior year quarter, primarily attributable to a $26 million net benefit from an adjustment to legal reserves related to the Mission Support Alliance joint venture.

Health

Health revenues for the quarter of $591 million increased by $61 million, or 11.5%, compared to the prior year quarter. The revenue increase was primarily attributable to a net increase in volumes on certain programs and program wins, partially offset by the completion of certain contracts.

Health operating income margin for the quarter was 17.3%, compared to 13.8% in the prior year quarter. On a non-GAAP basis, operating income margin for the quarter was 18.6%, compared to 15.5% in the prior year quarter, primarily attributable to a net increase in higher margin program volumes.

Cash Flow Summary

Net cash provided by operating activities for the quarter was $239 million compared to $372 million in the prior year quarter. The decrease in cash inflows was primarily due to the lower customer advance payments, lower sale of accounts receivable and the timing of vendor payments.

Net cash used in investing activities for the quarter was $244 million compared to $1,685 million in the prior year quarter. The decrease in cash outflows was primarily due to net cash paid related to the acquisition of 1901 Group in the current year quarter compared to net cash paid related to the acquisition of Dynetics in the prior year quarter.

Net cash used in financing activities for the quarter was $148 million compared to net cash provided by financing activities of $1,161 million in the prior year quarter. The decrease in cash inflows was primarily due to proceeds received related to the issuance of the Bridge Facility in the prior year quarter, $100 million of open market stock repurchases in the current year quarter and the timing of quarterly principal payments, partially offset by capital contributions to Hanford Mission Integration Solutions from non-controlling interests.

As of April 2, 2021, we had $377 million in cash and cash equivalents and $4.8 billion of debt.

New Business Awards

Net bookings totaled $3.8 billion in the quarter, representing a book-to-bill ratio of 1.2.

Notable recent awards received include:

Military and Family Life Counseling Support Services: The Company was awarded a new prime contract to provide non-medical counseling to military service members and their families through the Military and Family Life Counseling (MFLC) program. Under the contract, Leidos will provide face-to-face non-medical counseling, consultation and outreach services at approximately 100 U.S. military installations or nearby civilian communities. Leidos will also provide management and logistical support for counselors to provide services in accordance with established performance measures. The award has a total estimated value of approximately $1 billion and includes a 12-month base period with four 12-month options and two 12-month award term incentive periods.
U.S. Customs and Border Protection Multi-Energy Portal Systems Support: The Company was awarded a prime contract by U.S. Customs and Border Protection (CBP) to provide Multi-Energy Portal (MEP) systems for non-intrusive inspection of commercial vehicles at land and sea ports of entry. Under the contract, Leidos will integrate, deploy and train CBP staff to use its VACIS MEP with low-energy backscatter and high-energy transmission cargo inspection system. The multiple-award indefinite delivery/indefinite quantity contract has a total value of $480 million and includes a five-year base period of performance and options up to 10 years, if exercised.
Naval Array Technical Support Center Services: The Company was awarded a prime contract by the Naval Undersea Warfare Center – Newport Division to provide engineering, technical and management services for the Naval Array Technical Support Center. Under the contract, Leidos will perform tasks for the U.S. Navy’s Sensors and SONAR Systems Department. Leidos will be responsible for production engineering, technical and logistics support of the Navy and foreign governments’ towed array assets. The single-award, indefinite delivery/indefinite quantity, cost-plus-fixed-fee and firm-fixed-price contract has a total estimated value of $149.2 million.
U.S. Intelligence Community: The Company was awarded contracts valued at $822 million, if all options are exercised, by U.S. national security and intelligence clients. Though the specific nature of these contracts is classified, they all encompass mission-critical services that help to counter global threats and strengthen national security.
Backlog at the end of the quarter was $32.6 billion, of which $7.0 billion was funded.

Forward Guidance

As a result of the Company’s year-to-date performance and updated expectations, the Company is revising its fiscal year 2021 guidance as follows:

Revenues of $13.7 billion to $14.1 billion, remained unchanged from previous guidance;
Adjusted EBITDA margins of 10.5% to 10.7%, up from 10.3% to 10.5%;
Non-GAAP diluted EPS of $6.35 to $6.65, up from $6.15 to $6.45; and
Cash flows provided by operating activities at or above $875 million, up from previous guidance of $850 million.
Non-GAAP diluted EPS excludes amortization of acquired intangible assets, acquisition, integration and restructuring costs and other tax adjustments. For additional information regarding non-GAAP diluted EPS and Leidos’ other non-GAAP financial measures, see the related explanations and reconciliations to GAAP measures included elsewhere in this release.

The Company does not provide a reconciliation of forward-looking adjusted EBITDA margins (non-GAAP) or non-GAAP diluted EPS to GAAP net income, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income may vary significantly based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income at this time. The amounts of these deductions may be material and, therefore, could result in projected GAAP net income and diluted EPS being materially less than projected adjusted EBITDA margins (non-GAAP) and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8:00 A.M. eastern time on May 4, 2021. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (toll-free U.S.) or +1 (201) 689-8261 (international callers).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international callers) and entering conference ID 13718327.

On May 4, 2021 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has completed a Private Placement ("Placement") of new shares to new and existing institutional and sophisticated investors (Press release, Amplia Therapeutics, MAY 4, 2021, View Source;TE [SID1234579120]). The Placement will raise a total of approximately $3.8 million at an issue price of $0.23 per new, fully paid, ordinary share representing a 10.0% discount to the 15-day volume weighted price of shares traded up to 29 April 2021.

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A total of 16,585,000 new shares will be issued within the Company’s placement capacity under ASX Listing Rules 7.1 and 7.1A. The new shares are expected to be issued on 7 May 2021.

The placement was strongly supported by the Company’s largest shareholders, Platinum Investment Management Ltd. and Blueflag Holdings Pty Ltd. A new institutional shareholder, Acorn Capital, also participated in the Placement.

The proceeds from the Placement will be used to fund enabling activities for the Company’s planned Phase 2 clinical trials in pancreatic cancer and pulmonary fibrosis and provide working capital for the Company. The Phase 2 enabling activities include manufacture of drug substance and drug product, conduct of additional toxicology studies to support extended dosing in pulmonary fibrosis patients and clinical planning and lodgement of regulatory filings to support clinical trials in patients with pancreatic cancer.

Commenting on the results of the Placement, Amplia’s Chief Executive Officer DrJohn Lambert said "We are delighted to receive the continuing support of existing investors as well as to welcome new investors to our register. Over the last year, Amplia has put in place the necessary foundations for our planned Phase 2 clinical program for AMP945. Specifically, the recent completion of dosing in our Phase 1 trial of AMP945 together with the exciting results we have seen in our parallel non-clinical studies have provided the clinical safety data and preclinical rationale needed for us to push forward into Phase 2 clinical studies."

Taylor Collison acted as Lead Manager for the Placement.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On May 4, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it is a national sponsor of the Colorado Melanoma Foundation, a non-profit organization (Press release, Castle Biosciences, MAY 4, 2021, View Source [SID1234579138]). Castle will collaborate with the Colorado Melanoma Foundation and Epiphany Dermatology to provide free skin cancer screenings and public education through the Sun Bus initiative. The Sun Bus is a mobile skin cancer screening station and sun safety education classroom.

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The Colorado Melanoma Foundation and The Sun Bus, beginning in May, will travel to locations in Texas, Colorado, Arizona and New Mexico, providing free skin cancer checks, as well as educating visitors on ways to prevent skin cancer deaths through free sun safety education sessions.

"The purpose of the 2021 Sun Bus Free Skin Cancer Screening Tour is to help re-engage public attention on skin cancer screening as we come out of the pandemic," stated Dr. Neil Box, director of the Sun Bus and president of the Colorado Melanoma Foundation. "Most of us have been focused on maintaining social distancing and helping limit the spread of COVID-19, but it is important not to neglect our regular health screenings."

"May is Skin Cancer Awareness Month, and it is an important time for us to reiterate our commitment to improving the lives of patients with skin cancer," said Derek Maetzold, president and chief executive officer of Castle. "Our collaboration with the Colorado Melanoma Foundation and the Sun Bus initiative is intended to help educate the public and encourage early detection and screening. With our suite of dermatologic diagnostic tests, we’re passionate about providing patients with the most accurate and personalized care. And that begins with screenings, awareness and an understanding of the risks of skin cancer."

To see when The Sun Bus is in your area, visit View Source

On May 4, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has received a response from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application that the study for selection and treatment of Prostate-Specific Membrane Antigen (PSMA) positive prostate cancers using 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA may proceed (Press release, Clarity Pharmaceuticals, MAY 4, 2021, View Source [SID1234579036]).

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The SECuRE trial (Systemic Cu theranostics in prostate cancer) is a Phase I/IIa study for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC), which will be conducted in the U.S. (NCT04868604)1. It is a theranostic multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients. The trial employs diagnostic Positron Emission Tomography imaging with 64Cu-SAR-bisPSMA for selection of patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide2. The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease3. For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC. Annually, there are around ~34,000 men in the U.S. who are diagnosed with mCRCP3, ~90% of whom have tumours which express PSMA4.

Although there are some new therapeutic radiopharmaceutical agents for prostate cancer in late phase clinical trials, given the large patient population, product supply for therapeutic radiopharmaceuticals presents a constraint as they rely on the production of therapeutic isotopes from a small number of nuclear reactors, with reactor shutdowns often causing isotope shortages around the globe.

Clarity’s SAR-bisPSMA product utilises two isotopes of copper, which do not have the same constraints:

The therapeutic product utilises copper-67, which is being produced domestically in the USA on electron accelerators, avoiding the issues commonly associated with the production of isotopes on nuclear reactors.
The diagnostic product utilises copper-64, which is regularly produced in significant volumes on cyclotrons in the U.S., and has a half-life of 12.7 hours, avoiding the short half-life issues of other diagnostic isotopes.
The diagnostic and therapeutic products can be centrally manufactured and shipped as finished product direct to the treatment centres, which removes the need for dedicated radiopharmacy facilities at treatment centres.
Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval, "The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer, whose prognosis is currently very poor, but also validates Clarity’s copper pairing paradigm and the centralised manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications."

"We are very excited to commence the SECuRE trial in mCRCP patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of 64/67Cu SAR-bisPSMA. Clarity’s Global Clinical Development Group has unrivalled experience in the commercialisation of the only currently approved radiotherapeutic for prostate cancer. The FDA response is a crucial milestone in the development of SAR-bisPSMA theranostics and we are looking forward to progressing this trial at some of the leading cancer centres in the U.S. as part of our ultimate goal of developing better treatments for children and adults with cancer," said Dr Taylor.

Reference List
National Institute of Health, U.S. National Library of Medicine, View Source
World Cancer Research Fund, Prostate Cancer Statistics, View Source
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
A. Silver, I. Pellicer, W. R. Fair, W. D. Heston and C. Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3, 81-85, January 1997

On May 4, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will participate at the BofA Securities 2021 Virtual Health Care Conference (Press release, Ascendis Pharma, MAY 4, 2021, View Source [SID1234579063]). Company executives will provide a business overview and an update on the Company’s pipeline programs.

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Details

Event BofA Securities 2021 Virtual Health Care Conference
Location Virtual
Date Tuesday, May 11, 2021
Time 4:15 p.m. Eastern Time
A live audio webcast of the presentation will be available on the Investors and News section of the Company’s website at www.ascendispharma.com. A webcast replay will also be available on the Company’s website shortly after conclusion of the event for 30 days.