Teva Pharmaceutical Industries Ltd (TEVA) SEC Filing 10-Q Quarterly report for the period ending Tuesday, June 30, 2020

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Teva Pharmaceutical Industries Ltd
Ticker: TEVA CIK: 818686

Exhibit 99.1

Teva Reports Second Quarter 2020 Financial Results

Revenues of $3.9 billion

GAAP diluted EPS of $0.13

Non-GAAP diluted EPS of $0.55

Free cash flow of $582 million

Full year 2020 business outlook reaffirmed:

Net revenues of $16.6 - $17 billion

EBITDA of $4.5 - $4.9 billion

EPS of $2.30 - $2.55

Free cash flow of $1.8 - $2.2 billion

TEL AVIV, Israel--(BUSINESS WIRE)--August 5, 2020--Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) today reported results for the quarter ended June 30, 2020.

Mr. Kåre Schultz, Teva's President and CEO, said, “As the COVID-19 pandemic continues to impact the globe, Teva remains focused on our patients and communities while continuing to take robust measures to safeguard the health and well-being of our employees. During the quarter, we experienced lower sales of our generic and OTC products in all regions. The lower generics and OTC sales in Europe and International Markets were in line with our expectations, after the unusually high demand seen in the prior quarter due to the initial response to the pandemic. Our performance in the first half of the year, however, matched or exceeded that of the similar period last year. Our profitability – and in particular our free cash flow – were strong, allowing us to continue to reduce our net debt to $23.9 billion and to reaffirm our 2020 outlook."

Mr. Schultz continued, "During the quarter we made progress with many of our growth drivers, including the launch of the AJOVY^® auto-injector in the U.S., the continued launch of AJOVY in the EU, the launch of the biosimilar TRUXIMA^® for rheumatoid arthritis in the U.S. and approval of AUSTEDO^® in China. Additionally, we recently announced the launch of ProAir^® DigiHaler^® in the U.S. and the submission of an application for manufacturing and marketing approval of AJOVY in Japan. As we look forward to the second half of 2020, we remain fully committed to serving society and our stakeholders with critical and accessible medicines and to ensuring Teva meet its targets."

Phase 3 fasinumab results announced with Regeneron

In September 2016, Teva and Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into a collaborative agreement to develop and commercialize Regeneron’s pain medication product, fasinumab. Results for two phase 3 clinical trials, FACT OA1 and FACT OA2, were released on August 5, 2020, indicating that the co-primary endpoints for fasinumab were achieved. Fasinumab 1 mg monthly demonstrated significant improvements in pain and physical function over placebo at week 16 and week 24, respectively. Fasinumab 1 mg monthly also showed nominally significant benefits in physical function in two trials and pain in one trial, when compared to the maximum FDA-approved prescription doses of non-steroidal anti-inflammatory drugs for osteoarthritis. The FACT OA1 trial included an additional treatment arm, fasinumab 1 mg every two months, which showed numerical benefit over placebo, but did not reach statistical significance. In initial safety analyses from the phase 3 trials, there was an increase in arthropathies reported with fasinumab. In a sub-group of patients from one phase 3 long-term safety trial, there was an increase in joint replacement with fasinumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date. Additional longer-term safety data from the ongoing trials are being collected, and are expected to be reported early next year.

The following information was filed by Teva Pharmaceutical Industries Ltd (TEVA) on Wednesday, August 5, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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