PRA Health Sciences, Inc. Reports First Quarter 2018 Results

On April 25, 2018 PRA Health Sciences, Inc. ("PRA" or the "Company") (NASDAQ:PRAH) reported financial results for the quarter ended March 31, 2018 (Press release, PRA Health Sciences, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344607 [SID1234525698]).

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For the three months ended March 31, 2018, revenue was $701.8 million, which represents growth of 43.9%, or $214.1 million, compared to the first quarter of 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $198.3 million, an increase of 40.7% compared to the first quarter of 2017. On January 1, 2018, the Company adopted Accounting Standards Codification Topic 606, "Revenue from Contracts with Customers," or ASC 606, using the modified retrospective method for all contracts that were not completed as of January 1, 2018. The prior periods were not restated under this guidance and remain as previously reported. The primary impact of applying this new guidance on our statement of operations is that (i) we now recognize reimbursements from our customers for payments to investigators as revenue, whereas these payments and costs were previously recorded on a net basis, and (ii) we include all reimbursed costs in the total project costs when measuring our progress under our research contracts instead of recording these amounts on a separate basis.


Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $132.8 million, which represents growth of 31.1% at actual foreign exchange rates and 28.5% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $56.8 million of revenue attributable to our Data Solutions segment, was 17.8% at actual foreign exchange rates and 15.2% on a constant currency basis.

Net new business for our Clinical Research segment for the quarter ended March 31, 2018 was $650.3 million, representing a net book-to-bill ratio of 1.29 for the period. Our calculation of the net book-to-bill ratio excludes the revenue impact of adopting ASC 606, excludes reimbursement revenue and excludes revenue from our Data Solutions segment. Net new business during the quarter contributed to an ending backlog of $3.8 billion at March 31, 2018.

"We are off to another solid start and our first quarter results were in line with our expectations" said Colin Shannon, PRA’s Chief Executive Officer. "We continue to execute across the business and I was really pleased with our double-digit revenue and earnings growth and our 1.29 book-to-bill ratio. We are focused on client deliverables and our key strategic objectives, and we look forward to delivering strong results for the rest of 2018."

Direct costs were $381.4 million during the three months ended March 31, 2018 compared to $287.5 million for the first quarter of 2017. The increase in direct costs was primarily due to an increase in labor-related costs of $50.9 million in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels for our current studies and our future growth. In addition, our Data Solutions segment resulted in $40.6 million of incremental direct costs when compared to the first quarter of 2017. We also had an unfavorable impact of $14.0 million from fluctuation in foreign currency exchange rates during the three months ended March 31, 2018. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, direct costs were 68.1% of revenue during the first quarter of 2018 compared to 67.3% of revenue during the first quarter of 2017. The increase in direct costs as a percentage of revenue was primarily due to the aforementioned increase in salaries and related benefits.

Selling, general and administrative expenses were $91.7 million during the three months ended March 31, 2018 compared to $74.3 million for the first quarter of 2017. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, selling, general and administrative costs were 16.4% of revenue during the first quarter of 2018 compared to 17.4% of revenue during the first quarter of 2017. The decrease in selling, general and administrative expenses as a percentage of revenue is primarily attributable to our ability to continue to effectively leverage our selling and administrative functions.

Transaction-related costs represent changes in the fair value of contingent consideration related to our recent acquisitions. During the three months ended March 31, 2018, we recorded an $11.6 million reduction in the fair value of the earn-out liability associated with the Symphony Health acquisition, which reflects updates to the current estimate.

GAAP net income was $39.0 million for the three months ended March 31, 2018, or $0.59 per share on a diluted basis, compared to GAAP net income of $25.2 million for the three months ended March 31, 2017, or $0.39 per share on a diluted basis.

EBITDA was $98.8 million for the three months ended March 31, 2018, representing an increase of 70.9% compared to the first quarter of 2017. The increase in EBITDA was driven by lower foreign currency losses and the revaluation of the acquisition-related earn-out liability discussed above. Adjusted EBITDA was $95.7 million for the three months ended March 31, 2018, representing growth of 38.2% compared to the first quarter of 2017.

Adjusted net income was $56.2 million for the three months ended March 31, 2018, representing 39.1% growth compared to the first quarter of 2017. Adjusted net income per diluted share was $0.85 for the three months ended March 31, 2018, representing 37.1% growth compared to the first quarter of 2017.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2018 guidance, to the corresponding GAAP measures is included in this press release.

Guidance

The Company is reaffirming its full year 2018 service revenue guidance to between $2.84 billion and $2.95 billion, GAAP net income per diluted share to between $2.80 and $2.95 and Adjusted Net Income per diluted share to between $4.00 and $4.15. We anticipate an annual effective income tax rate estimate of approximately 24%, which includes the expected impact of the Tax Cuts and Jobs Act enacted in the fourth quarter of 2017. 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 interpretations, analysis, and additional guidance that may be issued by regulatory agencies as it relates to the Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.25 and a GBP rate of 1.37. All other foreign currency exchange rates are as of January 31, 2018.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on April 26, 2018, 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 2471729. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.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 2471729.

Additional Information

A financial supplement with first quarter 2018 results, which should be read in conjunction with this press release, may be found in Investor Relations section of our website at investors.prahs.com in a document titled "Q1 2018 Earnings Presentation."

Calithera Biosciences Announces CB-839 Abstracts Accepted for Presentation at ASCO 2018

On April 25, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that three abstracts describing CB-839, the Company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 1 to June 7, 2018 in Chicago, Illinois (Press release, Calithera Biosciences, APR 25, 2018, View Source [SID1234535240]).

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Calithera’s collaborators will present the following results:

Phase I clinical trial of the glutaminase inhibitor CB-839 plus capecitabine in patients with advanced solid tumors Abstract #2562 Presenter: Jennifer R. Eads, M.D., Case Comprehensive Cancer Center
Date: June 4, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall
A Developmental Therapeutics–Clinical Pharmacology and Experimental Therapeutics Funding for this study was provided in part by Stand Up To Cancer1. Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.

CANTATA: A randomized phase 2 study of CB-839 in combination with cabozantinib vs. placebo with cabozantinib in patients with advanced metastatic renal cell carcinoma.
Abstract #TPS4601 Presenter: Nizar M. Tannir, M.D., MD Anderson Cancer Center
Date: June 2, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Genitourinary (Non-Prostate) Cancer

Novel PET/CT imaging biomarkers of CB-839 in combination with panitumumab and irinotecan in patients with metastatic and refractory RAS wildtype colorectal cancer: A phase I/II study Abstract #TPS3616 Presenter: Satya Das, M.D., Vanderbilt University Cancer Center Date: June 3, 2018 Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Gastrointestinal (Colorectal) Cancer About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

Puma Biotechnology to Host Conference Call to Discuss First Quarter Financial Results

On April 25, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Wednesday, May 9, 2018 following release of its first quarter 2018 financial results (Press release, Puma Biotechnology, APR 25, 2018, http://investor.pumabiotechnology.com/press-release/puma-biotechnology-host-conference-call-discuss-first-quarter-financial-results [SID1234525699]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the Company’s website for 90 days.

Invitation to Roche Analyst Event at ASCO 2018

We are pleased to invite you to an analyst briefing to discuss data presented on the Roche Group’s oncology products and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) in Chicago (1 – 5 June 2018) (Press release, Hoffmann-La Roche, APR 25, 2018, View Source [SID1234525663]).

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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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Date/Time (CDT)
Monday, 4 June 2018

5:00pm Registration desk opens
5:30pm Start of meeting
7:00pm End of meeting followed by a buffet reception

Venue
Marriott Downtown Chicago
540 North Michigan Avenue
60611 Chicago
map

To register for the event, please follow the link (Password: Analyst2018).

A live video webcast can be accessed via View Source." target="_blank" title="View Source." rel="nofollow">View Source

The presentation slides will be available from the IR website at View Source following to the closure of the ASCO (Free ASCO Whitepaper) meeting.

In order to receive your personal dial-in details and expedite your access to the conference call, please pre-register under this link.

If you have not pre-registered, please find the dial-in numbers below, we recommend you to dial in to the conference 10-15 min prior to the scheduled start.

+41 (0) 58 310 5000 (Europe and ROW)
+44 (0) 207 107 0613 (UK)
+1 (1) 631 570 5613 (USA Toll Free)

Boston Biomedical Inc. Initiates Two Studies Evaluating WT1 Cancer Peptide Vaccine DSP-7888 (ombipepimut-S*)

On April 25, 2018 Boston Biomedical, Inc., an industry leader in the development of next-generation cancer therapeutics, reported that it has initiated dosing of the first patient in each of two clinical studies evaluating DSP-7888, an investigational cancer peptide vaccine (Press release, Boston Biomedical, APR 25, 2018, View Source [SID1234525682]). One study is in combination with checkpoint inhibitors for multiple tumor types, and the other is in combination with bevacizumab in glioblastoma. DSP-7888 is hypothesized to induce Wilms’ tumor gene 1 (WT1)-specific cytotoxic T lymphocytes (CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic cancers and solid tumors. WT1 has been a focus of cancer vaccine researchers since the National Cancer Institute ranked it as the number one priority target for cancer immunotherapy.[i]

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"Despite significant advances in cancer treatment, there remains a need for new, effective treatment options for many patients," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. "We are exploring the potential of DSP-7888 to elicit an anti-tumor response in a number of high unmet need tumor types."

The multicenter, open-label, phase 1b study of DSP-7888 in combination with checkpoint inhibitors, known as WIZARD101CI, is targeted to enroll approximately 84 patients who will receive either DSP-7888 in combination with nivolumab or in combination with atezolizumab. The primary endpoints of the study are determination of safety, tolerability, and recommended phase 2 dose. Secondary endpoints include duration of response, disease control rate, progression-free survival (PFS) at six months, median PFS, survival at 12 months and overall survival (OS). This study will be conducted in patients with advanced solid tumors including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, and urothelial cancer. Further information about this study is available at www.ClinicalTrials.gov (NCT03311334).

The multicenter, global phase 2 study of DSP-7888 in combination with bevacizumab in glioblastoma, known as WIZARD201G, is targeted to enroll approximately 200 patients with recurrent or progressive glioblastoma following treatment with first-line therapy consisting of surgery and radiation with or without chemotherapy. Patients will receive either DSP-7888 in combination with bevacizumab or bevacizumab alone. The primary endpoint of the study is OS, with secondary endpoints including survival at 12 months, PFS at six months, median PFS, response rate (complete response + partial response), duration of response, and adverse event profile. Further information about this study is available at www.ClinicalTrials.gov (NCT03149003).

DSP-7888 is also being investigated in early phase studies in patients with pediatric high grade gliomas, myelodysplastic syndrome, and other malignant tumors. In 2017, the U.S. Food and Drug Administration granted DSP-7888 Orphan Drug Designation in myelodysplastic syndrome and brain cancer.

*Adegramotide/nelatimotide is also assigned as its international nonproprietary name (INN).

About DSP-7888

DSP-7888 is an investigational cancer peptide vaccine containing peptides that induce WT1-specific CTL and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.[ii]

DSP-7888 is currently being investigated in three monotherapy studies: a phase 1/2 study in myelodysplastic syndrome (MDS) (NCT02436252), a phase 1/2 study in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891), and a phase 1 study in advanced malignancies (NCT02498665). DSP-7888 is currently being investigated in combination with bevacizumab in a phase 2 study in patients with recurrent or progressive glioblastoma (NCT03149003), and in a phase 1 study in combination with nivolumab or atezolizumab in patients with advanced solid tumors (NCT03311334). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer. More information on DSP-7888 and ongoing clinical studies can be found at www.BostonBiomedical.com.