On October 30, 2019 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended September 30, 2019 (Press release, PRA Health Sciences, OCT 30, 2019, View Source [SID1234550044]).

"Our third quarter financial results produced solid revenue growth and double digit earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the quarter we finalized a $500.0 million stock repurchase plan and repurchased and retired $300.0 million of common stock in connection with KKR’s clean-up trade. We are excited for our next chapter and I would like to thank KKR for their partnership. Our focus will remain on delivering shareholder returns and also delivering broad and flexible services to our clients. We look forward to continuing to position PRA for success in the future."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Net new business for our Clinical Research segment for the three months ended September 30, 2019 was $669.4 million, representing a net book-to-bill ratio of 1.22 for the period. This net new business contributed to an ending backlog of $4.6 billion at September 30, 2019.

For the three months ended September 30, 2019, revenue was $780.7 million, which represents growth of 8.8%, or $63.1 million, compared to the three months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $69.3 million, an increase of 9.7% compared to the third quarter of 2018. By segment, the Clinical Research segment generated revenues of $719.0 million, while the Data Solutions segment generated revenues of $61.7 million.

Direct costs, exclusive of depreciation and amortization, were $389.3 million during the three months ended September 30, 2019 compared to $371.4 million for the three months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased $24.6 million compared to the third quarter of 2018. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 49.9% of revenue during the third quarter of 2019 compared to 51.8% of revenue during the third quarter of 2018.

Selling, general and administrative expenses were $95.5 million during the three months ended September 30, 2019 compared to $92.6 million for the three months ended September 30, 2018. Selling,

general and administrative costs were 12.2% of revenue during the third quarter of 2019 compared to 12.9% of revenue during the third quarter of 2018.

GAAP net income was $83.0 million for the three months ended September 30, 2019, or $1.25 per share on a diluted basis, compared to GAAP net income of $1.5 million for the three months ended September 30, 2018, or $0.02 per share on a diluted basis.

Adjusted net income was $87.2 million for the three months ended September 30, 2019, representing growth of 16.6% compared to the three months ended September 30, 2018. Adjusted net income per diluted share was $1.32 for the three months ended September 30, 2019, representing growth of 16.8% compared to the three months ended September 30, 2018.

EBITDA was $128.6 million for the three months ended September 30, 2019, representing an increase of 99.6% compared to the three months ended September 30, 2018. Adjusted EBITDA was $137.8 million for the three months ended September 30, 2019, representing growth of 14.0% compared to the three months ended September 30, 2018.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2019 guidance, to the corresponding GAAP measures is included in this press release.

Nine Months Ended September 30, 2019 Financial Highlights

For the nine months ended September 30, 2019, revenue was $2,266.0 million, which represents growth of 5.8%, or $123.7 million, compared to the nine months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $150.7 million, representing growth of 7.0% compared to the nine months ended September 30, 2018.

Reported GAAP income from operations was $262.5 million, reported GAAP net income was $168.2 million and reported GAAP net income per diluted share was $2.53 for the nine months ended September 30, 2019.

Adjusted Net Income was $242.3 million for the nine months ended September 30, 2019, an improvement of 22.9% compared to the same period in 2018. Adjusted Net Income per diluted share was $3.64 for the nine months ended September 30, 2019, up 22.1% compared to the same period in 2018.

Guidance

The Company is maintaining its 2019 revenue guidance between $3.02 billion and $3.10 billion, representing as reported growth of 5% to 8% and constant currency growth of 6% to 8%. We are updating our GAAP net income per diluted share to between $3.58 and $3.64 and Adjusted Net Income per diluted share to between $5.07 and $5.12, representing growth of 18% to 20%.

We continue to estimate our annual effective income tax rate at approximately 24%. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of September 30, 2019.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on October 31, 2019, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 6427745. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 6427745.

Additional Information

A financial supplement with third quarter 2019 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 "Q3 2019 Earnings Presentation."

On October 30, 2019 The Mary Kay FoundationSM, a decades-long leader in the mission to eliminate cancers affecting women, reported that donated $100,000 to Baylor Scott & White Dallas Foundation to help fund research conducted by Dr. Joyce O’Shaughnessy, breast oncologist with TEXAS Oncology and the Celebrating Women Chair in breast cancer research at Baylor University Medical Center (Press release, The Mary Kay Foundation, OCT 30, 2019, View Source [SID1234550060]). Dr. O’Shaughnessy’s deep portfolio of research includes the study of triggers that may cause heightened sensitivity of triple negative breast cancer (TNBC) cells and the effectiveness of therapies based on this sensitivity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

TNBC is a high-risk breast cancer with few effective options for patients. It usually affects younger women, African American women, and women with a BRCA1 genetic mutation. Compared with other breast cancer subtypes, TNBC is associated with a worse prognosis, including shorter time to recurrence in early-stage diseases (within 3 years) and a shorter time between recurrence and death in the metastatic setting (between 9-12 months).

"At The Mary Kay Foundation, our mission is to eradicate cancers that affect women around the world, and each year we invest millions in groundbreaking research and support for organizations like Baylor Scott & White," said Dr. Lucy Gildea, Chief Scientific Officer of Mary Kay Inc. "We’re honored to help fund Dr. O’Shaughnessy’s potentially lifesaving research, and we look forward to following along and learning how these results might impact the prognosis of metastatic TNBC patients in the future."

Dr. O’Shaughnessy has focused her research on the metastatic TNBC population due to the very high, unmet medical need. Dr. O’Shaughnessy has worked with Baylor Scott & White Research Institute, which oversees research efforts and provides staffing and other clinical support for the healthcare system, to also design and develop Investigator Initiated Studies examining TNBC.

"The goal of this work is to understand more about the pathways that might allow patients to achieve highly durable complete responses to their treatment and to determine the molecular characteristics of TNBCs that predict the benefit from different treatment strategies," said Dr. O’Shaughnessy. "This type of work could expand the options available to patients with metastatic diseases and bring greater hope to those in need."

"As the largest not-for-profit healthcare system in Texas, Baylor Scott & White relies upon generous donations from organizations like The Mary Kay FoundationSM to continue our innovative research on behalf of patients," said Rowland K. Robinson, president of Baylor Scott & White Dallas Foundation. "We’ve seen promising results from Dr. O’Shaughnessy’s trials so far. And, with The Mary Kay Foundation’s support, we’re hopeful her important work will continue to help us gain additional insight to better serve those with metastatic triple negative breast cancer."

Over the course of more than two decades, The Mary Kay FoundationSM has awarded more than $80 million to women’s shelters and domestic violence service providers, as well as cancer research programs and related causes throughout the United States.

On October 30, 2019 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its third quarter and year-to-date 2019 financial results on Wednesday, November 6, 2019, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, OCT 30, 2019, View Source [SID1234550076]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Wednesday, November 6, 2019. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 2599456.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 2599456.

On October 30, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Designations from the European Commission (EC) for paclitaxel and encequidar ("Oral Paclitaxel") for the treatment of soft tissue sarcoma, following a positive opinion from the European Medicines Agency (EMA) (Press release, Athenex, OCT 30, 2019, View Source [SID1234573893]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "We are very pleased to receive Orphan Designations from the European Commission, as this further recognizes the potential benefits of Oral Paclitaxel. Earlier this year, we shared encouraging early results from a clinical study in angiosarcoma, a form of soft tissue sarcoma, that showed rapid responses in a difficult to treat patient population. We will soon be extending this study to include sites in Europe."

The EC grants Orphan Designation status to support development of medicines for the treatment of diseases that affect fewer than 5 in 10,000 people in the European Union and provide a significant benefit to those affected by the condition. Orphan Designation may provide certain benefits, including protocol assistance, fee reductions, and a ten-year period of market exclusivity if the drug is approved.

The U.S. FDA has granted oral paclitaxel and encequidar an Orphan Drug Designation in the treatment of angiosarcoma.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On October 30, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that its third quarter 2019 operational progress and financial results will be released before the market opens on Thursday, November 7, 2019 (Press release, Atara Biotherapeutics, OCT 30, 2019, View Source [SID1234550029]). Following the release, the Company will host a live conference call and webcast at 8:00 a.m. EST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.