On April 25, 2018 Varian (NYSE: VAR) reported its second quarter fiscal year 2018 results (Press release, Varian Medical Systems, APR 25, 2018, View Source [SID1234525702]).

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We are proud of the team’s progress in the second quarter toward executing on our long-term value creation strategy," said Dow Wilson, Chief Executive Officer of Varian. "We continued to strengthen our leadership in radiation therapy and extend our global footprint with the Mobius and Evinance acquisitions. In addition, we are expanding our addressable markets into interventional oncology with the acquisition of Sirtex, expected to close by the end of May."

The company ended the quarter with $740 million in cash and cash equivalents and $255 million of debt. Net cash provided by operating activities was $66 million. During the quarter, the company invested $36 million to repurchase 325,000 shares of common stock.

Oncology Systems Segment
In the fiscal second quarter, Oncology revenues totaled $698 million, up 10 percent in dollars and 6 percent in constant currency. Gross orders were $664 million, up 5 percent in dollars and 1 percent in constant currency. Gross orders in the Americas increased 2 percent in dollars and in constant currency. In EMEA, gross orders rose 11 percent in dollars and were flat in constant currency; in APAC, gross orders increased 3 percent in dollars and 1 percent in constant currency. Operating earnings for the segment increased 16 percent.

Particle Therapy Segment
In the fiscal second quarter, Particle Therapy revenues totaled $32 million, up 2 percent. The company did not book any new ProBeam orders in the quarter.

Acquisition-Related Expenses and Impairment Charges in Q2
Varian’s GAAP net earnings include acquisition-related expenses totaling $20 million for the quarter, primarily driven by $16 million related to hedging the Australian dollar purchase price of the Sirtex acquisition, as well as an impairment charge of $11 million related to the expected refinancing of the Maryland Proton Treatment Center in Baltimore. These costs and the associated tax effects reduced Varian earnings in the second quarter of fiscal 2018 by $0.26 per diluted share on a GAAP basis, and were excluded from non-GAAP results.

FY18 Annual Guidance Updated
Considering the financial and operational performance in the first half and the impact of currency, fiscal year 2018 guidance is updated to the following:

Revenue growth range of 6 percent to 9 percent, which now includes the impact from currency for the remainder of the year
Non-GAAP Operating earnings as a percentage of revenues range of 18 percent to 19 percent
Non-GAAP effective tax rate of 20 percent
Weighted average diluted shares of 93 million
Non-GAAP Earnings per diluted share range of $4.43 to $4.53
Cash flow from operations range of $475 million to $550 million
This updated guidance does not reflect the impact of the Sirtex acquisition, which is expected to close at the end of May.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its second quarter fiscal year 2018 conference call at 2 p.m. PT today. To hear a live webcast or replay of the call, visit the investor relations page on our web site at www.varian.com/investors where it will be archived for a year. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering confirmation code 13677574. The telephone replay will be available through 5 p.m. PT, Friday, April 27, 2018.

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.

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."

On April 25, 2018 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that new interim results from the Company’s ongoing Phase 2a study of cerdulatinib in patients with Non-Hodgkin Lymphoma (NHL), including B-cell NHL and relapsed/refractory peripheral T-cell lymphoma (PTCL), will be presented during a Poster Discussion Session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 1-5, in Chicago (Press release, Portola Pharmaceuticals, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344587 [SID1234525697]).

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Cerdulatinib is an investigational oral, dual SYK/JAK kinase inhibitor that uniquely inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies. It is being developed for the treatment of resistant or relapsed hematologic cancer.

Poster Presentation Details:

Presentation Title: The Dual SYK/JAK Inhibitor Cerdulatinib Demonstrates Rapid Tumor Responses in a Phase 2 Study in Patients with Relapsed/Refractory B- and T-Cell Non-Hodgkin Lymphoma (NHL)

Presenter: Paul A. Hamlin, M.D., Memorial Sloan Kettering Cancer Center

Abstract Number: 7511

Poster Board: 148

Session Title: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 2018 from 1:15 p.m. – 2:30 p.m. CT

Location: E450, McCormick Place

On April 25, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported that two abstracts pertaining to the company’s indoximod program will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Press release, NewLink Genetics, APR 25, 2018, View Source [SID1234525696]).

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Poster Discussion Session: Poster Board #204 – Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT

Poster Discussion Session: Poster Board #339 – Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT

The complete text of abstracts selected for presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting will be posted to the ASCO (Free ASCO Whitepaper) website on Wednesday, May 16th at 5pm ET.

"We are pleased to have the opportunity to present the results at ASCO (Free ASCO Whitepaper) from both of these Phase 2 trials of indoximod in combination therapies for patients with pancreatic cancer and advanced melanoma. We continue to gather data supporting the potential for our differentiated IDO pathway inhibitor, indoximod, in multiple combinations to improve the lives of patients with cancer," said Nicholas N. Vahanian, MD, President.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, chemotherapy, radiation and cancer vaccines across multiple indications such as melanoma, pancreatic cancer and other malignancies.