On August 4, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported select preliminary unaudited second quarter financial and operating results (Press release, EDAP TMS, AUG 4, 2021, View Source [SID1234585920]). The company anticipates reporting total second quarter revenue of approximately EUR 10.4 million (USD $12.4 million), representing an increase of 11.8% over EUR 9.3 million (USD $10.3 million) in the second quarter of 2020. First half total company revenue of EUR 20.7 million (USD $24.8 million) increased 22.5% over EUR 16.9 million (USD $18.7 million) for the first half of 2020.

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "While the effects of the COVID pandemic continued to impact hospital capital equipment timelines and our overall HIFU revenue during the second quarter, we made steady progress building further clinical validation with leading reference centers. We are seeing a robust pipeline of Focal One opportunities and believe several leading institutions will begin offering treatments during the second half of the year."

"Notwithstanding the weakness in hospital capex, however, we were very pleased to see significant growth – 79% – in our U.S. treatment volumes, a metric that we regard as a key leading indicator of HIFU utilization. The significant growth in the number of treatments performed is a very positive trend that reflects accelerating adoption of HIFU in the US. With the successful financing that we completed in April, we exited the second quarter with cash of more than $53 million and are well financed to continue to execute against our U.S. growth and expansion plans."

Management plans to release full second quarter 2021 financial and operating results after the close of the market on Wednesday, August 25 and host a conference call and webcast the following day.

Q2 2021 Conference Call and Webcast Details:

Note: exchange rates used in the conversion of EUR to USD are: H1 2021=1.2008, 1H 2020=1.1063, Q2 2021=1.2024, Q2 2020=1.1093

On August 3, 2021 Incyte (Nasdaq:INCY) reported 2021 second quarter financial results and provides a status update on the Company’s development portfolio (Press release, Incyte, AUG 3, 2021, View Source [SID1234585576]).

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"In the second quarter, we saw an acceleration of growth of Jakafi (ruxolitinib) and encouraging uptake in Europe for Pemazyre (pemigatinib). In addition, the recent positive CHMP opinion for tafasitamab and the potential subsequent launch of tafasitamab (Minjuvi) in Europe represents another significant growth opportunity for Incyte," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We continue to achieve clinical development success across our portfolio with positive outcomes from multiple programs, including topline results from ruxolitinib cream’s pivotal trials in vitiligo (TRuE-V), 52-week safety and efficacy data of ruxolitinib cream in atopic dermatitis (TRuE-AD), Phase 2 data of parsaclisib in autoimmune hemolytic anemia (AIHA) and the achievement of bioequivalence with once-daily (QD) ruxolitinib."

Portfolio Update

MPNs and GVHD – key highlights

Ruxolitinib in GVHD: Data from the REACH3 trial of ruxolitinib versus best available therapy (BAT) in patients with steroid-refractory chronic graft-versus-host disease (GVHD) have been published in The New England Journal of Medicine. The supplemental New Drug Application (sNDA) seeking approval of ruxolitinib for the treatment of steroid-refractory chronic GVHD is under review; the Prescription Drug User Fee Act (PDUFA) date was extended to September 22, 2021.

LIMBER (Leadership In MPNs BEyond Ruxolitinib): Bioavailability and bioequivalence data were published for ruxolitinib’s QD extended release (XR) formulation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress. QD ruxolitinib is in stability testing with an NDA submission planned for early 2022. Clinical studies evaluating ruxolitinib in combination with parsaclisib, INCB57643 (BET) and INCB00928 (ALK2), are progressing as expected.

Updated interim data from the proof-of-concept trial evaluating parsaclisib in combination with ruxolitinib in myelofibrosis (MF) patients with an inadequate response to ruxolitinib monotherapy were also presented at EHA (Free EHA Whitepaper).

Indication and status

Once-a-day ruxolitinib
(JAK1/JAK2)

Myelofibrosis, polycythemia vera and GVHD:
clinical pharmacology studies

ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)

Myelofibrosis: Phase 3 (first-line therapy) (LIMBER‑313)
Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER‑304)

ruxolitinib + INCB57643
(JAK1/JAK2 + BET)

Myelofibrosis: Phase 2 in preparation

ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)

Myelofibrosis: Phase 2 in preparation

itacitinib
(JAK1)

Myelofibrosis: Phase 2 (second-line therapy)

ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)

Myelofibrosis: PoC in preparation

ruxolitinib
(JAK1/JAK2)

Steroid-refractory chronic GVHD2: sNDA under review

itacitinib
(JAK1)

Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS‑309)

1 Development collaboration with Cellenkos, Inc.

2 Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis

Other Hematology/Oncology – key highlights

Tafasitamab: In June, Incyte and MorphoSys announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).

Updated three-year data from the Phase 2 L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL were presented at EHA (Free EHA Whitepaper). Multiple studies evaluating tafasitamab as a backbone therapy in various combinations for the treatment of patients with DLBCL, follicular lymphoma, marginal zone lymphoma and other B-cell malignancies are underway, including two Phase 3 trials (inMIND and frontMIND) currently ongoing. An additional proof of concept trial (coreMIND) of tafasitamab in combination with parsaclisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) is expected to start in the next six months.

Pemigatinib: The ongoing launch in the United States continues to go well and the recent launches in Europe and Japan are on track. FIGHT-207, evaluating pemigatinib in tumor agnostic FGFR malignancies, is now closed to recruitment. Based on findings from this study, Incyte has identified populations that may potentially benefit from treatment with pemigatinib and intends to initiate Phase 2 studies in glioblastoma and non-small cell lung cancer by early next year.

Retifanlimab: In July, Incyte announced that the FDA issued a complete response letter for the Biologics License Application (BLA) for retifanlimab as a treatment for squamous cell carcinoma of the anal canal (SCAC). Registration-directed trials of retifanlimab in MSI-high endometrial and Merkel cell carcinoma are ongoing. The Marketing Authorization Application (MAA) seeking approval of retifanlimab in SCAC remains under review with the European Medicines Agency (EMA).

Indication and status

pemigatinib
(FGFR1/2/3)

CCA: Phase 2 (FIGHT‑202), Phase 3 (FIGHT‑302)
Myeloid/lymphoid neoplasms (MLN): Phase 2 (FIGHT‑203)
Tumor agnostic: Phase 2 (FIGHT-207)
Glioblastoma: Phase 2 in preparation
NSCLC: Phase 2 in preparation

tafasitamab
(CD19)1

r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); CHMP+ opinion
1L DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND)
r/r FL and r/r MZL: Phase 3 (inMIND)
r/r CLL: Phase 2 (coreMIND) in preparation
r/r B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ) in preparation
r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation2

parsaclisib
(PI3Kδ)

r/r FL: Phase 2 (CITADEL‑203)
r/r MZL: Phase 2 (CITADEL‑204)
r/r MCL: Phase 2 (CITADEL‑205)
r/r FL and r/r MZL: Phase 3 (CITADEL‑302) in preparation
1L MCL: Phase 3 (CITADEL‑310) in preparation

retifanlimab
(PD‑1)3

SCAC: Phase 2 (POD1UM‑202); Phase 3 (POD1UM‑303); CRL from FDA; MAA under review
MSI-high endometrial cancer: Phase 2 (POD1UM‑101, POD1UM‑204)
Merkel cell carcinoma: Phase 2 (POD1UM‑201)
NSCLC: Phase 3 (POD1UM‑304)

CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma; MCL = mantle cell lymphoma; CLL = chronic lymphocytic leukemia

1 Development of tafasitamab in collaboration with MorphoSys

2 Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab.

3 Retifanlimab licensed from MacroGenics

Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

Ruxolitinib cream: In June, 52-week safety and efficacy data from the two Phase 3 TRuE-AD studies evaluating ruxolitinib cream in mild-to-moderate atopic dermatitis were presented at the Revolutionizing Atopic Dermatitis (RAD) virtual symposium. These data were the basis for an NDA seeking approval of ruxolitinib cream for the treatment of atopic dermatitis (AD); the PDUFA date has been extended to September 21, 2021.

A Phase 3 trial (TRuE-AD3) evaluating ruxolitinib cream in children (ages 2 to <12 years) with atopic dermatitis is ongoing.

In May, Incyte announced positive topline results from its pivotal Phase 3 TRuE-V program of ruxolitinib cream in adolescent and adult patients with vitiligo. Both TRuE-V1 and TRuE-V2 studies met the primary and key secondary endpoints, including patient reported outcomes. The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data, and no new safety signals were observed. The long-term efficacy and safety portions of both studies will continue as planned. The regulatory submission seeking approval of ruxolitinib cream in vitiligo is expected later this year.

Other IAI

Parsaclisib: At EHA (Free EHA Whitepaper), Incyte presented Phase 2 data evaluating parsaclisib in autoimmune hemolytic anemia. The majority of patients achieved a response with parsaclisib over the initial 12-week treatment period. Treatment with parsaclisib was generally well tolerated. Based on these results, Incyte plans to initiate a Phase 3 trial by end of year.

Indication and status

ruxolitinib cream
(JAK1/JAK2)

Atopic dermatitis: NDA under review; Phase 3 pediatric study ongoing (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2, primary endpoint met in both studies); sNDA in preparation

INCB54707
(JAK1)

Hidradenitis suppurativa: Phase 2b
Vitiligo: Phase 2

parsaclisib
(PI3Kδ)

Autoimmune hemolytic anemia: Phase 2; Phase 3 in preparation

INCB00928
(ALK2)

Fibrodysplasia ossificans progressiva: Phase 2 in preparation

Discovery and early development – key highlights

Incyte’s portfolio of other earlier-stage clinical candidates is summarized below.

Modality

Candidates

Small molecules

INCB01158 (ARG)1, INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1), INCB106385 (A2A/A2B)

Monoclonal antibodies2

INCAGN1876 (GITR), INCAGN2385 (LAG‑3), INCAGN1949 (OX40), INCAGN2390 (TIM‑3), INCA00186 (CD73)

Bispecific antibodies

MCLA‑145 (PD-L1xCD137)3

1 INCB01158 development in collaboration with Calithera

2 Discovery collaboration with Agenus

3 MCLA‑145 development in collaboration with Merus

Partnered – key highlights

Baricitinib: In July, Incyte and Lilly announced that the FDA would not meet the PDUFA action date for the sNDA for baricitinib for the treatment of adults with moderate to severe atopic dermatitis. Baricitinib is also being studied in alopecia areata with an expected submission in H2 2021.

Indication and status

Baricitinib
(JAK1/JAK2)1

Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and Japan; sNDA under review
Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2)
Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II)

capmatinib
(MET)2

NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan

1 Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis

2 Worldwide rights to capmatinib licensed to Novartis

Corporate Update

After almost 20 years at Incyte, Wenqing Yao, Ph.D. has announced his retirement as Executive Vice President and Head of Medicinal Chemistry. Dr. Yao will be succeeded by a member of his senior leadership team.

2021 Second Quarter Financial Results

The financial measures presented in this press release for the three and six months ended June 30, 2021 and 2020 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Financial Highlights

Product and Royalty Revenues Product and royalty revenues for the quarter ended June 30, 2021 increased 17% over the prior year comparative period as a result of increases in Jakafi, Iclusig and Pemazyre net product revenues and higher product royalty revenues from Jakavi, Olumiant and Tabrecta.

1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.

2 Non-GAAP research and development expenses exclude the cost of stock-based compensation.

3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and a legal reserve.

4 Non-GAAP change in fair value of acquisition-related contingent consideration is null.

Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2021 increased 20% and 24%, respectively, compared to the same period in 2020, primarily due to the progression of our pipeline including parsaclisib and our 55% share of the global and U.S. specific development costs for tafasitamab as well as product supply related costs to support the potential launch of ruxolitinib cream as a treatment for atopic dermatitis. Excluding the $12 million impact of incremental product supply costs and upfront and milestone payments, GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2021 increased approximately 16% and 20%, respectively, compared to the same period in 2020.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2021 increased 43% and 46%, respectively, compared to the same period in 2020, primarily due to expenses related to the establishment of our dermatology commercial organization and activities to support the potential launch of ruxolitinib cream for the treatment of atopic dermatitis.

Other Financial Information

Operating income (loss) GAAP and Non-GAAP operating income for the quarter ended June 30, 2021 decreased by $90 million and $93 million, respectively, compared to the same period in 2020 primarily due to an $85 million decrease in milestone and contract revenues.

Cash, cash equivalents and marketable securities position As of June 30, 2021 and December 31, 2020, cash, cash equivalents and marketable securities totaled $2.1 billion and $1.8 billion, respectively.

2021 Financial Guidance

Incyte is tightening its full year 2021 guidance for Jakafi net product revenues to reflect the impact of higher than anticipated government rebates and chargebacks and the new PDUFA date for ruxolitinib for the treatment of steroid-refractory chronic GVHD and is revising upward the range for other Hematology/Oncology net product revenues based on the performance of Pemazyre in the first half of 2021. In addition, the Company is reducing the range for selling, general and administrative expense to reflect lower expenses for ruxolitinib cream as a treatment for atopic dermatitis in the U.S. based on the PDUFA date extension to September 21, 2021. Guidance does not include revenue from any potential new product launches or the impact of any potential future strategic transactions. Incyte’s updated guidance is summarized below.

1 Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.

2 Adjusted to exclude the estimated cost of stock-based compensation.

3 Adjusted to exclude the estimated cost of stock-based compensation and a legal reserve.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877‑407‑3042 for domestic callers or 201‑389‑0864 for international callers. When prompted, provide the conference identification number, 13718346.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877‑660‑6853 and the dial-in number for international callers is 201‑612‑7415. To access the replay you will need the conference identification number, 13718346.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

On August 3, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.24 per share, payable on September 21, 2021 to shareholders of record on September 3, 2021 (Press release, Perrigo Company, AUG 3, 2021, View Source [SID1234585598]).

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On August 3, 2021 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the second quarter of fiscal year 2021 (Press release, Leidos, AUG 3, 2021, View Source [SID1234585614]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented, "Our results in the second quarter reflect our leadership position in the government technology market. I am tremendously proud of the way Leidos has responded throughout the pandemic, as our employees and business partners continually delivered for our customers and shareholders. While we remain vigilant with the recent uptick in COVID-19 cases, Leidos is stronger than ever, with new quarterly record levels of revenue and backlog consistent with our industry-leading organic growth."

Revenues for the quarter were $3.45 billion, up 18% compared to the prior year quarter. Excluding acquired revenues of $58 million, revenues increased 16% organically. Revenues grew across all reportable segments; the largest contributors were the increase in veterans’ disability examinations after the pause from the COVID-19 pandemic and the start-up of the Navy Next Generation IT contract.

Operating income for the quarter was $269 million, up 8.0% from the prior year quarter. Operating income margin decreased from 8.5% to 7.8% year-over-year as a result of the $81 million net gain recognized upon the receipt of proceeds related to the VirnetX, Inc. ("VirnetX") legal matter in the second quarter of fiscal year 2020. Net income attributable to Leidos shareholders was $169 million, or $1.18 per diluted share. Net income attributable to Leidos shareholders was up 10% and diluted EPS was up 11% from the second quarter of fiscal year 2020. The weighted average diluted share count for the quarter was 143 million compared to 144 million in the prior year quarter.

Adjusted EBITDA was $359 million for the second quarter, up 5% year-over-year; adjusted EBITDA margin decreased from 11.8% to 10.4% over the same period. Excluding the VirnetX gain in the prior period, adjusted EBITDA margin increased by 140 basis points in the quarter, primarily due to strong program management and better direct labor utilization. Non-GAAP net income was $218 million for the second quarter, which was down 2% year-over-year, and non-GAAP diluted EPS for the quarter was $1.52, which was down 2% compared to the second quarter of fiscal year 2020. Excluding the VirnetX gain, non-GAAP net income and diluted EPS were both up 37%.

Cash Flow Summary

Leidos generated $17 million of net cash provided by operating activities, used $396 million in investing activities, and provided $313 million by financing activities in the second quarter of fiscal year 2021. After adjusting for payments for property, equipment and software, quarterly free cash flow was an outflow of $4 million. The accounts receivable sale program decreased operating and free cash flow by $94 million. In addition, consistent with the high levels of organic growth, operating and free cash inflows ran below their typical levels to fund the start-up of new programs and the expansion of existing programs.

During the second quarter of fiscal year 2021, Leidos paid net consideration of $376 million to acquire Gibbs & Cox, Inc. ("Gibbs & Cox"), the largest independent ship design firm focused on naval architecture and marine engineering. The acquisition positions Leidos to provide a broad set of engineering solutions to the U.S. Navy and to an expanding set of foreign navies. To finance the acquisition, on May 7, 2021, Leidos entered into a senior unsecured term loan facility in an aggregate principal amount of $380 million with a maturity of 364 days.

In addition, Leidos paid down $27 million of debt and returned $48 million to shareholders as part of its regular quarterly cash dividend program. As of July 2, 2021, Leidos had $338 million in cash and cash equivalents and $5.1 billion of debt.

On July 30, 2021, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on September 30, 2021 to stockholders of record at the close of business on September 15, 2021. The $0.02 per share increase in the quarterly dividend reflects Leidos’ confidence in the future outlook and commitment to shareholder returns.

New Business Awards

Net bookings totaled $3.8 billion in the quarter, representing a book-to-bill ratio of 1.1. As a result, backlog at the end of the quarter was $33.5 billion, of which $7.2 billion was funded. Included in the quarterly bookings were several particularly important awards:

En Route Automation Modernization (ERAM) System. The Federal Aviation Administration (FAA) has awarded initial tasking as part of a single source contract award to Leidos for the continued system integration, sustainment, and enhancement of the En Route Automation Modernization (ERAM) system. The ERAM system is critical for continued operations in the National Airspace System (NAS) and provides automation services for the en route domain at the 20 Continental United States Air Route Traffic Control Centers. This potential contract has a ten-year base period followed by two five-year option periods and a total estimated value of approximately $6.8 billion, if all options are exercised.

Reserve Health Readiness Program III. Leidos was awarded a new prime contract by the U.S. Army Contracting Command-New Jersey to provide commercial health services to all U.S. military reserve component forces. Under the contract, QTC Medical Services, a Leidos company, will work with the Defense Health Agency program office to help ensure service members meet health requirements before, during and after deployment. Services will include physical, mental health and dental assessments along with laboratory and diagnostic services supported by a secure IT infrastructure and customer service call center. The single award, firm-fixed-price, cost-no-fee contract has a one-year base period of performance followed by four one-year options and a total estimated value of approximately $999 million, if all options are exercised.
In addition, Leidos received prime positions on several indefinite delivery/indefinite quantity (IDIQ) contracts that provide competitive differentiation and channels for future growth but are not included in bookings or backlog beyond any awarded task orders. The largest of these IDIQs were:

Transportation Security Administration Screening Equipment Deployment Services. Leidos was awarded a prime contract by the Transportation Security Administration (TSA) to provide services related to the deployment of Transportation Screening Equipment (TSE). Under the contract, Leidos will conduct surveys while providing on-site coordination, design support, planning and execution for screening equipment installations, relocations and removals. In addition to airports, the contract includes security support for special events, such as presidential inaugurations and spectator events, along with international efforts. The single-award IDIQ award has a total ceiling value of $470.7 million.

U.S. Air Force Intelligence Surveillance Reconnaissance Support. Leidos has been awarded a prime contract by the U.S. Air Force to provide solutions for a broad spectrum of aviation requirements for the Intelligence Surveillance Reconnaissance & Special Operations Forces (ISR/SOF) Directorate (WI), Sensors Division (WIN) Non-Standard Foreign Military Sales (FMS) branches. Under the contract, Leidos will provide a cadre of professionals and tools from across the industry to improve both U.S. and allied ISR capabilities. Leidos will also provide full aircraft and ISR sensor integration, procurement of hardware and spares, sustainment support and inspections for airworthiness/configuration. The multi-award IDIQ contract has a total estimated value of $950 million and includes a 13-year base period of performance with a 10-year ordering period and options up to three years, if exercised.
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.

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income attributable to Leidos shareholders, 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 attributable to Leidos shareholders may vary significantly based on actual events, Leidos 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 attributable to Leidos shareholders at this time. The amounts of these deductions may be material and, therefore, could result in projected net income attributable to Leidos shareholders and diluted EPS being materially less than projected adjusted EBITDA margins 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 August 3, 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 13720806.

On August 3, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, reported an amendment to the Company’s option for an exclusive license with Massachusetts General Hospital ("MGH") to include intellectual property ("IP") and technology related to the use of SYN-020 intestinal alkaline phosphatase ("IAP"), the Company’s proprietary recombinant version of bovine IAP, to inhibit liver fibrosis in select diseases, including nonalcoholic fatty liver disease ("NAFLD") (Press release, Synthetic Biologics, AUG 3, 2021, View Source [SID1234585629]).

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Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)

Synthetic Biologics previously announced an option agreement with MGH to negotiate an exclusive license to IP and technology for the use of SYN-020 to prevent and treat metabolic and inflammatory diseases associated with aging. The option agreement has now been expanded to include technology developed by MGH to use SYN-020 to inhibit liver fibrosis in select diseases, including NAFLD. If executed, the license agreement would further strengthen the SYN-020 portfolio and build upon the Company’s intention to pursue SYN-020 for the treatment of NAFLD, and, in particular, to slow the course of fibrosis associated with progressive disease.

"We are pleased to announce the expansion of our collaboration with Massachusetts’s General Hospital and share their enthusiasm for SYN-020’s potential to address diseases associated with liver fibrosis such as nonalcoholic fatty liver disease," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We continue to view SYN-020 as a potential platform therapeutic that has a remarkable opportunity to address a considerable unmet need for innovative new therapies targeting GI disorders stemming from immune and inflammatory responses."

Under the terms of the amended agreement, Synthetic Biologics is granted an option to negotiate an exclusive worldwide license with MGH to commercially develop SYN-020 to treat and prevent metabolic and inflammatory diseases associated with aging and fibrosis of the liver.

About SYN-020 Phase 1 SAD & MAD Clinical Trials

Synthetic Biologics recently announced the completion of patient dosing and observation of its Phase 1 single-ascending dose ("SAD") clinical trial of SYN-020 in 24 healthy adult volunteers. Results from this trial demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to SYN-020. No serious adverse events were reported. A second Phase 1 multiple-ascending dose ("MAD") clinical trial of SYN-020 in healthy adult volunteers is expected to commence during the third quarter of 2021 with topline results anticipated during the second quarter of 2022. Both Phase 1 SAD and MAD studies are intended to support the development of SYN-020 in multiple potential clinical indications, including celiac disease, radiation enteropathy, metabolic and inflammatory disorders associated with aging, and to inhibit fibrosis in select diseases, including NAFLD.

About SYN-020 Intestinal Alkaline Phosphatase (IAP)

SYN-020 is a recombinant bovine Intestinal Alkaline Phosphatase (IAP) formulated for oral delivery to the small intestine. The published literature indicates that IAP functions to diminish intestinal inflammation, tighten the gut barrier to diminish "leaky gut," and promote a healthy microbiome. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. Synthetic Biologics has overcome this hurdle and has the ability to produce SYN-020 at a scale and cost viable for clinical and commercial development. Synthetic Biologics is currently developing SYN-020 in multiple potential clinical indications, including celiac disease, nonalcoholic fatty liver disease (NAFLD), radiation enteritis, and indications to treat and prevent metabolic and inflammatory disorders associated with aging.