Danaher Reports Second Quarter 2019 Results

On July 18, 2019 Danaher Corporation (NYSE: DHR) reported results for the second quarter 2019. For the quarter ended June 28, 2019, net earnings were $731.3 million, or $0.97 per diluted share which represents a 2.0% year-over-year increase from the comparable 2018 period (Press release, Danaher, JUL 18, 2019, View Source [SID1234537612]).

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Non-GAAP adjusted diluted net earnings per share were $1.19 which represents a 3.5% increase over the comparable 2018 period. For the second quarter 2019, revenues increased 3.5% year-over-year to $5.2 billion, with non-GAAP core revenue growth of 5.5%.

Operating cash flow for the second quarter 2019 was $1.2 billion and non-GAAP free cash flow was $1.0 billion.

For the third quarter 2019, the Company anticipates that diluted net earnings per share will be in the range of $0.86 to $0.89 and non-GAAP adjusted diluted net earnings per share will be in the range of $1.12 to $1.15.

For the full year 2019, the Company now anticipates that diluted net earnings per share will be in the range of $3.38 to $3.43 versus previous guidance of $3.34 to $3.42. The Company is raising its 2019 non-GAAP adjusted diluted net earnings per share guidance to $4.75 to $4.80 versus previous guidance of $4.72 to $4.80.

Thomas P. Joyce, Jr., President and Chief Executive Officer, stated, "We are very pleased by our strong start to 2019, with our team’s execution driving another quarter of 5.5% core revenue growth. We believe that recent investments in innovation and commercial initiatives contributed to share gains in many of our businesses. Combined with solid operating margin expansion and cash flow generation, the strength of our results is a testament to our team and the power of the Danaher Business System."

Joyce added, "We continue to make progress on our anticipated acquisition of GE Biopharma and the planned initial public offering of our Dental business, which will be called Envista. Both transactions remain on track relative to our previously indicated expectations. We are excited about the opportunities ahead, and we believe the combination of our differentiated portfolio and our team’s DBS-driven execution positions us well to continue our strong performance through 2019 and beyond."

Danaher will discuss its results during its quarterly investor conference call today starting at 8:00 a.m. ET. The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available in the same section of Danaher’s website shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

The conference call can be accessed by dialing 866-503-8675 within the U.S. or by dialing +1 786-815-8792 outside the U.S. a few minutes before the 8:00 a.m. ET start and telling the operator that you are dialing in for Danaher’s investor conference call (access code 8699843). A replay of the conference call will be available shortly after the conclusion of the call and until July 25, 2019. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations." In addition, presentation materials relating to Danaher’s results have been posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings."

ABOUT DANAHER

Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life around the world. Its family of world class brands has leadership positions in the demanding and attractive health care, environmental and applied end-markets. With more than 20 operating companies, Danaher’s globally diverse team of approximately 71,000 associates is united by a common culture and operating system, the Danaher Business System, and our Shared Purpose, Helping Realize Life’s Potential. For more information, please visit www.danaher.com.

NON-GAAP MEASURES

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings release also contains non-GAAP financial measures. Calculations of these measures, the reasons why we believe these measures provide useful information to investors, a reconciliation of these measures to the most directly comparable GAAP measures and other information relating to these non-GAAP measures are included in the supplemental reconciliation schedule attached.

ViewRay Announces Conference Call and Webcast of Second Quarter 2019 Financial Results to be Held After Market on August 8, 2019

On July 18, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported that details relating to the release of its second quarter 2019 financial results (Press release, ViewRay, JUL 18, 2019, View Source [SID1234537611]).

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ViewRay will hold a conference call to discuss results on Thursday, August 8, 2019 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 1695303. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until August 15, 2019. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 1695303.

VolitionRx Limited Commences Lung Cancer Clinical Study with Fosun Long March in China

On July 18, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported that has executed a contract under the previously announced Memorandum of Understanding, with Shanghai Fosun Long March Medical Science Co., Ltd. ("Fosun Long March") to help introduce the Nu.Q(TM) platform to China (Press release, VolitionRX, JUL 18, 2019, View Source [SID1234537610]). Based on recent promising proof-of-concept data using Volition’s product-grade Nu.Q assays, the parties have commenced a clinical study in China in lung cancer.

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Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition, commented: "We are happy to have executed this agreement with Fosun Long March and are delighted that the clinical study is already underway and expected to be completed by the end of this year."

Dr. Yuejian Zhang, Chairman of Fosun Long March, remarked: "We were impressed with Volition’s preliminary data, particularly in lung cancer, and are happy to have started work on these initial clinical studies. Whilst China represents a little under 20% of the world’s population, it accounted for almost 24% of cancer diagnoses and 30% of cancer-related deaths worldwide in 2018, almost a third of which were due to lung cancer and colorectal cancer. We look forward to completing this important study and working together with Volition to launch Nu.Q in China."

"The need for a simple, easy to use, cost effective test for cancer is truly universal and we hope very much that our Nu.Q tests can help revolutionize the way cancer is diagnosed worldwide," commented Cameron Reynolds, Chief Executive Officer of Volition. "We see Asia, and particularly lung cancer in China, as a key market for Volition. We are excited about the commencement of our work in China and look forward to a successful collaboration with Fosun Long March."

About Fosun Long March

Established in 1989, Fosun Long March is the investment platform of in-vitro diagnostics division of Fosun Pharma Group and has since accelerated merger and acquisition of new products introduction into China. With its wide range of in-vitro diagnostics products, strength in manufacturing and strong nation-wide sales network, Fosun Long March is one of the most influential brands in in-vitro diagnostics in China.

Fosun Long March’s network and expertise will assist Volition with the facilitation and coordination of the collection, provision and testing of blood samples using Volition’s proprietary Nu.Q(TM) assays for the clinical studies, with Fosun’s hospitals, research institutions and clinics, as well as other third-party hospitals, universities, research institutions and clinics in China.

Alkermes to Host Conference Call to Discuss Second Quarter 2019 Financial Results

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Blueprint Medicines Announces European Medicines Agency Validation of Marketing Authorization Application for Avapritinib for the Treatment of PDGFRα D842V Mutant GIST and Fourth-Line GIST

On July 18, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that the European Medicines Agency (EMA) has validated the company’s Marketing Authorization Application (MAA) for avapritinib for the treatment of adult patients with PDGFRα D842V mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST (Press release, Blueprint Medicines, JUL 18, 2019, View Source [SID1234537608]). Validation of the MAA confirms that the application is sufficiently complete to begin the formal review process. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST. The European Commission has granted orphan medicinal product designation to avapritinib for the treatment of GIST.

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"Prognoses are traditionally poor for patients with PDGFRα D842V mutant GIST and fourth-line GIST, and currently no effective therapy exists for either population," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "Avapritinib is specifically designed to inhibit the disease drivers of GIST, including mutant kinases associated with treatment resistance, representing a promising therapeutic approach. We look forward to working expeditiously with the EMA to bring this potential new treatment option to patients."

In June 2019, Blueprint Medicines announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and fourth-line GIST.

About GIST

GIST is a sarcoma, or tumor of bone or connective tissue, of the gastrointestinal (GI) tract. Tumors arise from cells in the wall of the GI tract and occur most often in the stomach or small intestine. Most patients are diagnosed between the ages of 50 to 80, and diagnosis is typically triggered by GI bleeding, incidental findings during surgery or imaging and, in rare cases, tumor rupture or GI obstruction.

Most GIST cases are caused by a spectrum of clinically relevant mutations that force the KIT or PDGFRA protein kinases into an increasingly active state. Because currently available therapies primarily bind to the inactive protein conformations, certain primary and secondary mutations typically lead to treatment resistance and disease progression.

In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. Mutational testing is critical to tailor therapy to the underlying disease driver and is recommended in expert guidelines. Currently, there are no approved therapies for patients with KIT-driven GIST whose disease progresses beyond imatinib, sunitinib and regorafenib. In patients with metastatic PDGFRα D842V-driven GIST, progression occurs in a median of approximately three to four months with available therapy.

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRα D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia. The European Commission has granted orphan medicinal product designation to avapritinib for the treatment of GIST and mastocytosis.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.