PRA Health Sciences, Inc. Reports First Quarter 2021 Results

On April 28, 2021 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended March 31, 2021 (Press release, PRA Health Sciences, APR 28, 2021, View Source [SID1234578639]).

"I am delighted to report double-digit revenue and earnings growth for the first quarter of 2021" said Colin Shannon, PRA’s President and Chief Executive Officer. "The year has started on a strong note and we continue to be well-positioned for the remainder of 2021. We are working diligently preparing to close our merger with ICON, which is anticipated to close in July of this year."

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Net new business for our Clinical Research segment for the three months ended March 31, 2021 excluding reimbursement revenue was $797.2 million, representing growth of 31.8% and a net book-to-bill ratio of 1.24 for the period. Net new business for our Clinical Research segment for the three months ended March 31, 2021 including reimbursement revenue was $1,154.4 million, representing growth of 20.8% and a net book-to-bill of 1.33 for the period. We continue to see strength across the entire Clinical Research segment and our new business continues to be diversified across a number of different therapeutic areas. The mix of our new business awards continues to be in line with prior years with approximately 50% of our new business coming from large pharma and the remainder coming from mid-sized pharma and biotech. Net new business, excluding reimbursement revenue, contributed to an ending backlog at March 31, 2021 of $5.5 billion, an increase of 16.4% year over year.

For the three months ended March 31, 2021, revenue was $933.8 million, which represents an increase of 19.1%, or $150.1 million, compared to the three months ended March 31, 2020 at actual foreign exchange rates. On a constant currency basis, revenue increased $137.6 million, an increase of 17.6% compared to the first quarter of 2020. By segment, the Clinical Research segment generated revenues of $866.6 million, representing an increase of 19.3%, while the Data Solutions segment generated revenues of $67.1 million, representing an increase of 16.6%. Our customer concentration continues to be well-diversified, with our top five clients representing approximately 35% of revenue, with no client representing more than 10% of our revenue during the quarter.

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Direct costs, exclusive of depreciation and amortization, were $472.0 million during the three months ended March 31, 2021 compared to $403.9 million for the three months ended March 31, 2020 at actual foreign exchange rates. On a constant currency basis, direct costs increased $57.5 million compared to the first quarter of 2020. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment as we continue to hire to support our growth and increased data costs in our Data Solutions segment as we renew existing contracts and add new data assets. Direct costs were 50.5% of revenue during the first quarter of 2021 compared to 51.5% of revenue during the first quarter of 2020.

Selling, general and administrative expenses were $122.8 million during the three months ended March 31, 2021 compared to $107.0 million for the three months ended March 31, 2020. Selling, general and administrative costs were 13.1% of revenue during the first quarter of 2021 compared to 13.6% of revenue during the first quarter of 2020.

GAAP net income was $56.9 million for the three months ended March 31, 2021, or $0.86 per share on a diluted basis, compared to GAAP net income of $40.7 million for the three months ended March 31, 2020, or $0.63 per share on a diluted basis.

EBITDA was $114.4 million for the three months ended March 31, 2021, representing an increase of 10.8% compared to the three months ended March 31, 2020. Adjusted EBITDA was $135.8 million for the three months ended March 31, 2021, representing an increase of 21.1% compared to the three months ended March 31, 2020.

Adjusted net income was $89.6 million for the three months ended March 31, 2021, representing an increase of 33.0% compared to the three months ended March 31, 2020. Adjusted net income per diluted share was $1.35 for the three months ended March 31, 2021, representing an increase of 28.6% compared to the three months ended March 31, 2020.
Acquisition by ICON plc

On February 24, 2021, we entered into the a definitive merger agreement with ICON plc (ICON), ICON US Holdings Inc. (US Holdco) and Indigo Merger Sub, Inc. (Merger Sub). Under the terms of the merger agreement, Merger Sub will merge with and into PRA, with PRA surviving as a wholly owned subsidiary of ICON and US HoldCo. Upon successful completion of the merger, our stockholders will receive $80.00 per share in cash and 0.4125 ICON ordinary shares for each share of our common stock.

Conference Call Details

PRA will not hold a first quarter 2021 conference call.

Additional Information

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per share, to the corresponding GAAP measures is included in this press release.

A financial supplement with first quarter 2021 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q1 2021 Earnings Presentation."

Corporate Slide Presentation of Galera Therapeutics, Inc. dated April 28, 2021

On April 28, 2021 Galera Therapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, Galera Therapeutics, APR 28, 2021, View Source [SID1234578638]).

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ORIC Pharmaceuticals to Present Initial Data from Ongoing Phase 1b Study of ORIC-101 in Combination with Nab-paclitaxel at the 2021 ASCO Annual Meeting

On April 28, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021 (Press release, ORIC Pharmaceuticals, APR 28, 2021, View Source [SID1234578637]).

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"We are pleased to participate in the 2021 ASCO (Free ASCO Whitepaper) program and report initial data from the ongoing Phase 1b study of ORIC-101, our glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors," said Jacob Chacko, M.D., president and chief executive officer. "This represents the first of two data readouts from our two ongoing Phase 1b trials of ORIC-101. We expect to report initial data from the second trial, ORIC-101 in combination with enzalutamide in prostate cancer, in the second half of this year."

Poster Presentations:

Presentation Title: Initial results from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 2553

Presentation Title: Biomarker results supporting selection of RP2D from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 3110

The posters will be available at www.oricpharma.com/publications following presentation at the meeting.

BERGENBIO TO PRESENT AT THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING

On April 28, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that its abstract has been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place online from 4-8 June 2021 (Press release, BerGenBio, APR 28, 2021, View Source [SID1234578636]).

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Abstract titles have been announced online at View Source and details of the presentation are below. Full abstracts will be published on the ASCO (Free ASCO Whitepaper) website on 19 May 2021.

Title: Ph I/II study of oral selective AXL inhibitor bemcentinib (BGB324) in combination with erlotinib in patients with advanced EGFRm NSCLC: End of trial update

Session Title: Lung Cancer – Non-Small Cell Metastatic

Abstract ID: 9110

Date/Time: Friday, June 4, 2021 at 9:00 AM (EDT)

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the Sars-Cov-2 virus attaches and enters the host cell, and AXL expression is upregulated that leads to suppression of the Type 1 Interferon immune response by host cells and in their environment. Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and promotes the anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

Alpine Immune Sciences to Present ALPN-202 Clinical Data at the 2021 ASCO Virtual Annual Meeting

On April 28, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported an upcoming presentation on NEON-1, the company’s Phase 1 clinical trial of ALPN-202 monotherapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, scheduled to take place June 4-8, 2021 (Press release, Alpine Immune Sciences, APR 28, 2021, View Source [SID1234578635]).

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Details of the poster presentation are as follows:

Presentation Title:

First-in-human dose escalation of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies

Session Title:

Developmental Therapeutics—Immunotherapy

Date Poster Available:

Friday, June 4th

Abstract Number:

2547

The meeting presentation will update the data shown in the abstract.

Full abstracts will be available on the ASCO (Free ASCO Whitepaper) meeting website on May 19th, 2021 and a copy of the presentation will be available on June 4th on the Scientific Publications page of Alpine’s website.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling. Alpine also plans the initiation of NEON-2, a combination study of ALPN-202 and a PD-1 inhibitor, later this year.