Varian Reports Results for Second Quarter of Fiscal Year 2019

On April 24, 2019 Varian (NYSE: VAR) reported its second quarter fiscal year 2019 results (Press release, Varian Medical Systems, APR 24, 2019, View Source [SID1234535373]). All comparisons in this announcement are year-over-year, all quarter and year references are fiscal unless noted otherwise, and any references to orders are gross orders

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(1) Non-GAAP net earnings and Non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, impairment charges, significant litigation charges or benefits and legal costs, gains or losses on equity investments, and significant non-recurring tax expense or benefit.

"In the second quarter, we maintained strong momentum," said Dow Wilson, chief executive officer of Varian. "Each of our geographies delivered exceptional orders growth, including strong double-digit performance in APAC and the seventh consecutive quarter of double-digit growth in EMEA. Based on the company’s results year-to-date and our outlook for the rest of the year, we are raising our fiscal year revenue guidance to 6 to 9 percent while increasing investments in growth priorities such as groundbreaking preclinical research with our FlashForward Consortium."

The company ended the quarter with $546 million in cash and cash equivalents and no debt. Net cash used in operating activities was $13 million, down $79 million due to the tax payments and net working capital impacts from revenue growth. During the quarter, the company invested $51 million to repurchase 420,000 shares of common stock.

Oncology Systems Segment

In the second quarter, Oncology revenues totaled $747 million, up 7%. Operating earnings for the segment decreased 8%, primarily driven by the impact of tariffs, currency fluctuations and costs related to the ramp of our software deployment capabilities.

In the second quarter, Oncology orders were $766 million, up 15%. Orders in the Americas increased 7% driven by strong U.S. growth. In EMEA, orders rose 17%, the seventh consecutive quarter of double-digit growth for the region. In APAC, orders increased 35%, with accelerating growth in China.

Proton Solutions Segment

In the second quarter, Proton Solutions revenues totaled $33 million, up 2%. Operating earnings were negatively impacted by $7 million in increased project costs and site delays.

Guidance for Full Fiscal Year 2019

The company is raising revenue guidance and are otherwise reaffirming the following guidance for fiscal year 2019:

This updated guidance reflects increased project costs and site delays in our Proton Solutions business of $7 million, incremental investments in our preclinical research with the FlashForwardTM Consortium of $5 million, and costs related to the ramp of our software deployment capabilities of $2 million, partially offset by an estimated reduction in gross tariff impact of $5 million.

The guidance assumes a Non-GAAP effective tax rate of 21% to 22% and a weighted average diluted share count of 92 million, unchanged from our original assumptions. The guidance also assumes currency rates as of the beginning of the fiscal third quarter of 2019, includes the expected net impact of all tariffs effective as of the beginning of the fiscal year, and excludes any future acquisitions.

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 2019 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. 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 conference ID 13688640. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, April 26, 2019.

Supernus to Host First Quarter 2019 Earnings Conference Call

On April 24, 2019 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the first quarter of 2019 after 5:00 p.m. ET on Tuesday, May 7, 2019 (Press release, Supernus, APR 24, 2019, View Source [SID1234535372]).

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Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Chief Financial Officer, will host a conference call to present the first quarter 2019 business results on Wednesday, May 8, 2019 at 9:00 a.m. ET. Following management’s prepared analysis and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 8139879
Conference Call Name: Supernus Pharmaceuticals First Quarter 2019 Earnings Conference Call
Following the live call, a replay will be available on the Company’s website under the ‘Investor Relations’ section. The webcast will be available on the Company’s website for 60 days following the live call.

Medicure to Announce Fiscal Year End 2018 Financial Results on April 29, 2019

On April 24, 2019 Medicure Inc. ("Medicure") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported that it will release financial results for the year ended December 31, 2018 after markets close on Monday, April 29, 2019 (Press release, Medicure, APR 24, 2019, View Source [SID1234535368]). The financial statements will be made available on the Company’s website at www.medicure.com. Medicure will hold a conference call and webcast regarding the results on Tuesday, April 30, 2019 at 7:30 AM Central Time (8:30 AM Eastern Time).

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Conference Call Info:

Topic: Medicure’s Fiscal Year End 2018 Results

Call date: Tuesday, April 30, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 8925377#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

Clovis Oncology to Announce First Quarter 2019 Financial Results and Host Webcast Conference Call on May 7

On April 24, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its first quarter 2019 financial results on Tuesday, May 7, 2019, before the open of the U.S. financial markets (Press release, Clovis Oncology, APR 24, 2019, View Source [SID1234535367]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss first quarter 2019 results on Tuesday, May 7, at 8:30 a.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 877.698.7048, International participants 647.689.5448, conference ID: 8567356.

Tiziana Reports Encouraging Interim Clinical Data from an Ongoing Phase 2a Clinical Trial with Milciclib in Patients With Advanced Liver Cancer

On April 24, 2019 Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, reported results from the interim safety review conducted by the Independent Data Monitoring Committee ("IDMC") on 21 March 2019 (Press release, Tiziana Life Sciences, APR 24, 2019, View Source [SID1234535366]). The IDMC reviewed safety data from patients as of 26 February 2019, and concluded that the administration of milciclib to patients with advanced hepatocellular carcinoma ("HCC") was not associated with unexpected signs or signals of toxicity. Additionally, a number of patients are continuing with treatment under compassionate use. Topline data from this multi-center trial is expected to be available by the end of Q3 2019.

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Tiziana’s Milciclib Phase 2a clinical trial is a single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off every 4 weeks defining each cycle), 6-month duration study to evaluate the safety, tolerability and anti-tumor activity of Milciclib in Sorafenib-refractory or intolerant patients with unresectable or metastatic advanced HCC, the most common form of liver cancer. Enrollment of 31 patients in Italy, Greece, and Israel was completed on 30 November 2018.

The IDMC evaluated data from 28 out of the 31 patients who were evaluable. As of 16 April 2019, a total of 10 out of 27 patients have completed the study per protocol (6 cycles, 6 months). Four patients are still under treatment, while 3 are in cycle 6 and 1 is in cycle 5. Eight out of the 10 patients who completed treatment initially expressed interest to continue with treatment. Seven of these 8 patients were approved to continue with treatment under compassionate use by their respective ethical committees. Three of the patients under compassionate use have completed 9, 13, and 16 months of treatment with Milciclib. The other 4 patients are continuing with treatment.

To date, no drug-related deaths have been recorded. Overall, the treatment with Milciclib is well-tolerated with manageable drug-related toxicities. These safety and clinical activity are consistent with the earlier reported long-term safety and clinical activity of Milciclib in thymic carcinoma, thymoma and other solid cancers.

"Demonstration of safety and clinical activity is an important milestone to move forward with strategic options for further clinical development of Milciclib either as a single agent or in combination with one of the FDA approved drugs for treatment of HCC patients," said Dr Kunwar Shailubhai, CEO & CSO of Tiziana. "We previously reported data from preclinical studies demonstrating that Milciclib produced pronounced synergistic anti-HCC activity in combination with any one of the U.S. Food and Drug Administration approved drugs such as sorafenib (Nexavar), regorafenib (Stivarga), and lenvatinib (Lenvima)."

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO of Tiziana.

Cited References

Besse, B,, Garassino, M,, Rajan, A., Novello, S.,Mazieres, J., Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G. Giaccone. Efficacy of Milcicilib (PHA-848125AC), a pan-cyclin D -dependent kinase inhibitor in tow phase II studies with Thymic carcinoma and B3 thymoma patients. (2018) J. Clin. Onc 36 (15 suppl): 8519

Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017). Phase I dose-escalation study of milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265.

Jindal, A., Palejwala, V. and Shailubhai, K. (2018). Oral treatment with milciclib either alone or in combination with sorafenib inhibited tumor growth in an orthotopic model of hepatocellular carcinoma. Hepatology 68 Number 1 (Suppl): 879A (Abstract 1543)

About HCC

HCC is the fifth most common cancer and the third highest cause of cancer mortality worldwide. In 2007, the approval by the European Medical Agency and U.S. Food and Drug Administration of Sorafenib (Nexavar), an inhibitor of several receptor tyrosine kinases, in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of Sorafenib are modest, with a response rate less than 3%, an improvement in median survival of 2-3 months and drug-related symptoms that are not ordinary. More recently, lenvatinib (Lenvima ), another multi-tyrosine kinase inhibitor was also approved for first line treatment of HCC. The complex multi-factorial etiology of HCC warrants a need for systemic therapies that target different signaling cascades to provide improved efficacy and safety for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently associated with development of resistance towards chemotherapies. In a Phase 1 study, oral treatment with Milciclib was well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma. Additionally, milciclib met its primary endpoint in two separate Phase 2 multi-center clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in thymic carcinoma and thymoma patients.