On July 26, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter ended June 30, 2019 (Press release, Zimmer Holdings, JUL 26, 2019, View Source [SID1234537794]). The Company reported second quarter net sales of $1.989 billion, a decrease of 0.9% from the prior year period, and an increase of 1.2% on a constant currency basis. Diluted earnings per share for the second quarter were $0.65, a decrease of 28% from the prior year period. Second quarter adjusted diluted earnings per share were $1.93, an increase of 0.5% over the prior year period. Net earnings for the second quarter were $134 million and $398 million on an adjusted basis.

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"My level of confidence in our turnaround increases with every quarter," said Bryan Hanson, President and CEO of Zimmer Biomet. "Our team is focused, engaged and has positioned the company for offense in the second half of 2019. I’m truly excited by the momentum we are seeing and we have updated our guidance to reflect the progress we made in the first half of the year."

Geographic and Product Category Sales

The following sales tables provide results by geography and product category for the three and six month periods ended June 30, 2019, as well as the percentage change compared to the prior year periods, on both a reported basis and a constant currency basis.

Cash Flow and Balance Sheet

Operating cash flow for the second quarter was $301 million and free cash flow was $161 million. The Company paid down $115 million of debt, paid $49 million in dividends in the quarter and declared a second quarter dividend of $0.24 per share.

Guidance

The Company had previously stated that it expected to achieve constant currency revenue in line with its weighted average market growth rate starting in 2020. Given the progress made in the turnaround, the Company now believes it will achieve this goal beginning in the third quarter of 2019, six months earlier than previously expected. The Company provided updated 2019 financial guidance for the following metrics. All other previous guidance items remain unchanged:

Projected Year Ending December 31, 2019

2019 sales growth vs prior year is provided on an as reported basis and includes 125 to 175 basis points of negative foreign exchange impact (vs. 100 to 150 basis points previously).

These measures are non-GAAP financial measures for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts. See "Forward-Looking Non-GAAP Financial Measures."

Conference Call

The Company will conduct its second quarter 2019 investor conference call today, July 26, 2019, at 8:30 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

On July 26, 2019 Universal Health Realty Income Trust (NYSE: UHT) reported that for the three-month period ended June 30, 2019, reported net income was $4.3 million, or $.31 per diluted share, as compared to $5.8 million, or $.42 per diluted share, during the second quarter of 2018 (Press release, Universal Health Services, JUL 26, 2019, View Source [SID1234537793]).

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As calculated on the attached Schedule of Non-GAAP Supplemental Information ("Supplemental Schedule"), our funds from operations ("FFO"), were $11.0 million, or $.80 per diluted share, during the second quarter of 2019, as compared to $12.0 million, or $.88 per diluted share during the second quarter of 2018.

Our net income, adjusted net income and FFO for the three-month period ended June 30, 2018 included a net favorable impact of approximately $1.3 million, or $.10 per diluted share, consisting of the following: (i) a favorable impact of approximately $1.7 million, or $.12 per diluted share, received in connection with a lease termination agreement entered into during the second quarter of 2018 on a single-tenant medical office building located in Texas (the building has approximately 20,500 rentable square feet and this agreement terminated a lease that was scheduled to expire in July, 2020), partially offset by; (ii) an unfavorable impact of approximately $400,000, or $.02 per diluted share, consisting of non-recurring repairs and remediation expenses incurred at one of our medical office buildings. Also included in our net income and adjusted net income during the second quarter of 2018 was a favorable impact of $194,000, or $.01 per diluted share, of business interruption insurance recoveries recorded in connection with damage sustained from Hurricane Harvey which occurred in late August, 2017.

Consolidated Results of Operations – Six-Month Periods Ended June 30, 2019 and 2018:

For the six-month period ended June 30, 2019, our reported net income was $8.5 million, or $.62 per diluted share, as compared to $15.4 million, or $1.12 per diluted share during the first six months of 2018.

As reflected on the attached Supplemental Schedule, our financial results for the six-month period ended June 30, 2019 included a gain of $250,000, or $.02 per diluted share, related to the sale of a parcel of land located at one of our buildings. Our financial results for the six-month period ended June 30, 2018 included $4.5 million, or $.33 per diluted share, of hurricane insurance recoveries in excess of damaged property write-downs received in connection with damage sustained from Hurricane Harvey which occurred in August, 2017. Excluding the impact of these items from each respective six-month period, and as calculated on the Supplemental Schedule, our adjusted net income was $8.2 million, or $.60 per diluted share during the six-month period ended June 30, 2019, as compared to $10.9 million, or $.79 per diluted share during the six-month period ended June 30, 2018.

As also calculated on the Supplemental Schedule, our FFO were $21.9 million, or $1.60 per diluted share, during the first six months of 2019, as compared to $23.5 million, or $1.71 per diluted share, during the first six months of 2018.

Our net income and adjusted net income for the six months ended June 30, 2019 was unfavorably impacted by $355,000, or $.03 per diluted share, resulting from net asset write offs recorded in connection with early lease terminations or relocations that occurred during the first quarter of 2019 at three of our multi-tenant medical office buildings. As discussed above, our net income, adjusted net income and FFO for the six months ended June 30, 2018 included a net favorable impact of approximately $1.3 million, or $.10 per diluted share, related to the favorable impact from a lease termination agreement entered into during the second quarter of 2018 ($1.7 million, or $.12 per diluted share) partially offset by the unfavorable impact of the non-recurring repairs and remediation expenses incurred at one of our medical office buildings ($400,000, or $.02 per diluted share). In addition, our net income, adjusted net income and FFO during the six months ended June 30, 2018 included the favorable impact of approximately $1.2 million, or $.08 per diluted share, resulting from business interruption insurance recovery proceeds recorded during the six-month period ended June 30, 2018. Included in this amount, which covered the period of late August, 2017 through June 30, 2018 (after satisfaction of the applicable deductibles), was approximately $500,000, or $.04 per diluted share, related to the period of August, 2017 through December 31, 2017.

Dividend Information:

The second quarter dividend of $.68 per share, or $9.4 million in the aggregate, was declared on June 12, 2019 and paid on July 2, 2019.

Capital Resources Information:

At June 30, 2019, we had $191.6 million of borrowings outstanding pursuant to the terms of our $300 million credit agreement and $108.4 million of available borrowing capacity. The credit agreement has a scheduled maturity date of March, 2022, however, we have the option to extend the maturity date for up to two additional six-month periods.

Adoption of ASU 2016-02, "Leases (Topic 842): Amendments to the FASB Accounting Standards Codification":

Effective January 1, 2019, we adopted ASU 2016-02 which requires lessees to, among other things, recognize right-of-use assets and lease liabilities on the balance sheet. As a result of our adoption of ASU 2016-02, in connection with ground leases where we are the lessee, our consolidated balance sheet as of June 30, 2019 includes right-of-use land assets ($8.9 million) and ground lease liabilities ($8.9 million). Prior period financial statement amounts were not adjusted for the effects of this new standard.

On July 26, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported that the Company plans to release its second quarter 2019 financial results on Monday, August 5, 2019 after the market closes (Press release, China Biologic Products, JUL 26, 2019, View Source [SID1234537792]).

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The Company’s management will hold a conference call at 7:30 a.m. ET on Tuesday, August 6, 2019, which is 7:30 p.m. Beijing Time on August 6, 2019, to discuss second quarter 2019 results. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905945

China:

4001 201203

A telephone replay will be available one hour after the conclusion of the conference call through August 13, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10133955

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

On July 26, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that company management will be presenting at the Canaccord Genuity 39th Annual Growth Conference on Thursday, August 8, 2019 at 3:30 p.m. ET in Boston, MA (Press release, IMV, JUL 26, 2019, View Source [SID1234537791]).

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A live webcast of the presentation will be available under "Events, Webcasts and Presentations" in the Investors section of IMV’s website. The webcast will be available for replay approximately one hour after the presentation and will be archived for 90 days.

On July 26, 2019 Servier and its partner Taiho Pharmaceutical Co., Ltd reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for LONSURF (trifluridine/tipiracil) as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (Press release, Servier, JUL 26, 2019, View Source [SID1234537790]). The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.

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Gastric cancer in Europe affects approximately 130,000 people a year,1 and it is estimated that 40% of those patients will have metastatic disease.2 For those with advanced or metastatic disease the treatment options are limited and are often palliative.

"The positive opinion from the CHMP for LONSURF is very welcomed; patients with metastatic gastric cancer have few therapeutic options remaining, so it is of the upmost importance new therapies are made available. The Phase III trial TAGS demonstrated that LONSURF was effective and tolerable for these patients and gave patients valuable months of life," said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).

The marketing authorization application was supported by data from the global Phase III trial TAGS (TAS-102 Gastric Study) which was a randomized, double-blind study evaluating LONSURF, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. LONSURF demonstrated significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with LONSURF and BSC was 5.7 months compared to 3.6 months when treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of LONSURF in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.

"Today’s announcement is one step closer to ensuring patients with metastatic gastric cancer have another treatment option, bringing an incremental survival benefit over the standard of care," said Patrick Therasse, Head of Servier Research and Development Oncology. "Gastric cancer is difficult to treat and each step forward is a major event."

Currently in the EU, LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.3

#ENDS#

About Metastatic Gastric Cancer

Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and colorectal cancer), with an estimated 780,000 deaths annually.4　

When cancer spreads it is called advanced cancer. Locally advanced cancer is when the cancer has grown outside the organ it started in but hasn’t spread to other parts of the body. When the cancer spreads to other parts of the body, this is called metastatic cancer. In the last two decades, the proportion of patients with gastric cancer who present with metastases has risen to over 40%.2

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2/neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, there are neither approved nor standard third-line treatments in the EU.

About LONSURF3

LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In the EU, LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

As of July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 countries and regions. In February 2019, LONSURF has been approved as a treatment for mGC/mGEJC in the United States.

LONSURF was discovered and developed by Taiho Pharmaceutical. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia.