Arcadia Biosciences Announces Date of Third-Quarter 2019 Financial Results and Business Highlights Conference Call

On October 30, 2019 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a leader in science-based approaches to enhancing the quality and nutritional value of crops, reported that it will release its third-quarter 2019 financial and business results after market close on November 6, 2019 (Press release, Arcadia Biosciences, OCT 30, 2019, View Source [SID1234550078]).

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The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss third-quarter results and the quarter’s key strategic achievements. Interested participants can join the conference call using the following numbers:

U.S. Toll-Free Dial-In:

+1-844-243-4690

International Dial-In:

+1-225-283-0138

Passcode:

3489473

A live webcast of the conference call will be available on the Investors section of Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.

WuXi AppTec Reports Third-Quarter 2019 Results

On October 30, 2019 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 2359.HK), a company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients, reported its financial results for the third quarter and nine months ended September 30, 2019 ("Reporting Period") (Press release, WuXi AppTec, OCT 30, 2019, View Source [SID1234550077]).

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This document serves purely as a summary and is not intended to provide a complete representation of the relevant matters. For further information, please refer to the 2019 third quarterly report and relevant announcements published on the websites of the Shanghai Stock Exchange (www.sse.com.cn) and the Stock Exchange of Hong Kong (www.hkexnews.hk), and the designated media for dissemination of the relevant information. Investors are advised to exercise caution and be aware of the investment risks in dealing in the shares of the Company.

All financials disclosed in this press release are prepared based on International Financial Reporting Standards (or "IFRSs").

The 2019 Third-Quarter Report of the Company has not been audited.

Third-Quarter 2019 Financial Highlights

Accelerated revenue growth of 34.7% year-over-year to RMB 3,384 million, which was broad-based across all our business segments.
Gross profit grew 31.5% year-over-year to RMB 1,377 million. Gross profit margin was 40.7%.[3]
EBITDA grew 22.0% Year-Over-Year to RMB 1,155 million.
Adjusted EBITDA grew 51.6% Year-Over-Year to RMB 1,107 million.
Adjusted non-IFRS net profit attributable to owners of the Company grew 50.2% year-over-year to RMB 664 million.
Net profit attributable to owners of the Company grew 7.9% year-over-year to RMB 708 million. Net profit growth rate was slower than revenue growth rate due to RMB 227 million decrease in fair value gain of our investment portfolio from RMB 237 million in the third quarter of 2018 to RMB 10 million in the same period this year.
Adjusted diluted non-IFRS EPS increased by 36.7% versus the same period last year while diluted EPS was down 4.4%.[4]
Year-to-Date 2019 Financial Highlights

Accelerated revenue growth of 34.1% year-over-year to RMB 9,279 million.
Gross profit grew 30.6% year-over-year to RMB 3,660 million. Gross profit margin was 39.5%.[5]
EBITDA grew 7.3% Year-Over-Year to RMB 2,914 million.
Adjusted EBITDA grew 41.0% Year-Over-Year to RMB 3,006 million.
Adjusted non-IFRS net profit attributable to owners of the Company grew 38.0% year-over-year to RMB 1,842 million.
Net profit attributable to owners of the Company was lower 8.5% year-over-year to RMB 1,765 million, due to a RMB 45 million loss from changes in fair value of our investment portfolio for the first nine months of 2019, versus a RMB 669 million gain in the same period last year.
Adjusted diluted non-IFRS EPS increased by 17.7% versus the same period last year while diluted EPS was down 22.5%.[6]
Management Comment

Mr. Edward Hu, Co-CEO of WuXi AppTec, said, "Our growth continued to accelerate for the third quarter of 2019. In addition, we continue to focus on customer development and business conversion with a strategy of following the projects and following the molecules, leveraging synergies across all our business segments. For the nine months ended September 30, we have gained over 900 new customers and our number of active customers now exceed 3,700."

Mr. Edward Hu further commented, "During the Reporting Period, our success-based drug discovery unit filed INDs for 16 new-chemical-entities for domestic customers with the China National Medical Products Administration and obtained 20 CTAs. As of September 30, 2019, we have cumulatively submitted 71 new-chemical-entity IND filings with the NMPA for our customers and obtained 54 CTAs. As of September 30, 2019, our small molecule CDMO/CMO pipeline has grown to more than 900 active projects, including 40 projects in Phase III clinical trials and 17 in commercial manufacturing, and our cell and gene therapies CDMO business provided services for 33 clinical stage projects, including 24 projects in Phase I and 9 projects in Phase II/III. In September 2019, we also completed the issuance of USD 300 million zero-coupon convertible bonds, providing the Company with a strong balance sheet for investments, business expansion and potential M&A."

Dr. Ge Li, Chairman and CEO of WuXi AppTec, stated, "Our business model and the platform we have built continue to perform well. We continue to invest in new capabilities and capacities and believe these investments will allow the company to sustain our long term growth. We will continue to focus on enabling global partners and assisting them to bring the best medicines to patients in need, and to realize our vision that ‘every drug can be made and every disease can be treated’."

Third-Quarter 2019 IFRS Results

Revenue increased 34.7% year-over-year to RMB 3,384 million.
Gross profit increased 31.5% year-over-year to RMB 1,377 million. Gross profit margin was 40.7%, slightly lower than 41.7% in the three months ended September 30, 2018.[7]
EBITDA increased 22.0% Year-Over-Year to RMB 1,155 million.
Net profit attributable to owners of the Company increased 7.9% year-over-year to RMB 708 million. Net profit growth rate was slower than revenue growth rate, mainly due to a RMB 10 million gain in fair value of our investment portfolio for the third quarter of 2019, compared with a RMB 237 million gain in the same period last year which was primarily due to Hua Medicine and Unity Biotechnology stock price change after the IPO. Excluding the impact of changes in fair value of our investment portfolio, the net profit attributable to owners of the Company in the current period increased by 66.4% compared with the same period last year.
Third-Quarter 2019 Non-IFRS Results

Third-Quarter 2019 non-IFRS net profit attributable to owners of the Company increased 9.9% year-over-year to RMB 739 million. This adjusts for share-based compensation expenses, listing expenses and convertible bonds issuance expenses, distribution expenses for convertible bonds, foreign exchange-related effects and amortization of intangible assets acquired in business combinations.
Third-Quarter 2019 Adjusted Non-IFRS Results

Excluding realized/unrealized gains or losses from our venture investments and realized/unrealized gains or losses from our joint ventures, Third-Quarter 2019 adjusted non-IFRS net profit attributable to owners of the Company increased 50.2% year-over-year to RMB 664 million.
Year-to-Date 2019 IFRS Results

Revenue increased 34.1% year-over-year to RMB 9,279 million.
Gross profit increased 30.6% year-over-year to RMB 3,660 million. Gross profit margin was 39.5%, slightly lower than 40.5% in the nine months ended September 30, 2018.[8]
EBITDA increased 7.3% Year-Over-Year to RMB 2,914 million.
Net profit attributable to owners of the Company decreased 8.5% year-over-year to RMB 1,765 million, mainly due to a RMB 45 million loss in fair value of our investment portfolio for the first nine months of 2019, compared with a RMB 669 million gain in the same period last year which was primarily due to Hua Medicine and Unity Biotechnology stock price change after the IPO. Excluding the impact of changes in fair value of our investment portfolio, the net profit attributable to owners of the Company in the current period increased by 43.7% compared with the same period last year.
Year-to-Date 2019 Non-IFRS Results

Year-to-Date 2019 non-IFRS net profit attributable to owners of the Company decreased 3.9% year-over-year to RMB 1,952 million. This adjusts for share-based compensation expenses, listing expenses and convertible bonds issuance expenses, distribution expenses for convertible bonds, foreign exchange-related effects and amortization of intangible assets acquired in business combinations.
Year-to-Date 2019 Adjusted Non-IFRS Results

Excluding realized/unrealized gains or losses from our venture investments and realized/unrealized gains or losses from our joint ventures, Year-to-Date 2019 adjusted non-IFRS net profit attributable to owners of the Company increased 38.0% year-over-year to RMB 1,842 million.

ANI Pharmaceuticals Schedules Conference Call to Discuss Third Quarter and Year-to-Date 2019 Financial Results

On October 30, 2019 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its third quarter and year-to-date 2019 financial results on Wednesday, November 6, 2019, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, OCT 30, 2019, View Source [SID1234550076]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

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Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Wednesday, November 6, 2019. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 2599456.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 2599456.

PDL BioPharma to Announce Third Quarter 2019 Financial Results on November 6, 2019

On October 30, 2019 PDL BioPharma, Inc. ("PDL" or "the Company") (NASDAQ: PDLI) reported that it will release its third quarter 2019 financial results for the period ended September 30, 2019, on Wednesday, November 6, 2019, after market close (Press release, PDL BioPharma, OCT 30, 2019, View Source [SID1234550075]). PDL’s management will host a conference call and webcast that day at 4:30 p.m. Eastern time to discuss the operating and financial results and recent developments. A slide presentation relating to the call will be available via the webcast link on the PDL website at View Source

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Conference Call Details
To access the live conference call via phone, please dial (844) 535-4071 from the United States and Canada or (706) 679-2458 internationally. The conference ID is 3195828. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3195828.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website and go to "Events & Presentations." Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

European Commission Approves Astellas’ XOSPATA ™ for Patients with Relapsed or Refractory Acute Myelogenous Leukemia, Identifying Mutations Using Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay

On October 30, 2019 Invivoscribe Inc. reported that the European Commission (EC) has granted regulatory approval for the Astellas drug XOSPATA (gilteritinib) (Press release, Invivoscribe Technologies, OCT 30, 2019, View Source;825237203.html [SID1234550074]). This is a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations ( FLT3 mut +), which discovers from the Invivo leukostrat CDx FLT3 mutation assay can be.

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The LeukoStrat test is available as a test menu service through the subsidiaries of Invivoscribe LabPMM LLC ( San Diego , California, USA ), LabPMM GmbH (Martinsried, Germany), and LabPMM GK ( Kawasaki, Japan ). Test kits of the LeukoStrat CDx FLT3 mutation assay are currently distributed in Europe, Japan , Switzerland and Australia and are expected to be available in the United States and China in the future .

Invivoscribe has developed the LeukoStrat CDx FLT3 Mutation Assay in collaboration with Astellas as a companion diagnostic to predict patient response to Astellas Pharma’s AOS drug XOSPATA (gilteritinib fumarate). The current approval is based on the results of the Phase 3 ADMIRAL study in which gilteritinib is compared to second-line chemotherapy in patients with relapsed or refractory FLT3mut + -AML was investigated. There was a significantly higher Overall Survival (OS) in patients treated with gilteritinib than those who received second-line chemotherapy. The mean OS for patients receiving gilteritinib was 9.3 months, compared to 5.6 months for patients treated with second-line chemotherapy alone.

With this milestone, the LeukoStrat CDx FLT3 Mutation Assay can continue to establish itself as an international gold standard for comprehensive FLT3 assessment of critically ill AML patients. This is especially true because this CDx can identify both ITD and TKD FLT3 mutations (including large internal tandem duplications) and is globally available.

This approval completes the series of regulatory approvals previously received by Invivoscribe for the LeukoStrat CDx FLT3 mutation assay as an adjunctive diagnostic for Astellas XOSPATA (gilteritinib fumarate), Novartis RYDAPT (midostaurine) and Daichi Sankyo quizartineib hydrochloride.

"The approval by the European Commission is a significant forest step for patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia. Invivoscribe looks forward to additional treatment options that can extend the lives of patients, and the company looks forward to partnering with other pharmaceutical companies interested in using our Streamlined CDx program, whether its therapies for hematologic disease or cancer targeting solid tumors to accelerate drug approvals worldwide, "said Jeffrey Miller , CSO and CEO of Invivoscribe .

About the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test that incorporates internal tandem duplication (ITD) mutations and the D835 and I836 mutations in the Tyrosine kinase domain (TKD) can be detected in the FLT3 gene. The gene is derived from genomic DNA extracted from mononuclear cells derived from peripheral blood or bone marrow aspirate from patients diagnosed with acute myeloid leukemia.

The LeukoStrat CDx FLT3 Mutation Assay is used as a tool to evaluate patients with AML who are considering treatment with Midostaurin (United States, Europe, Switzerland and Australia).

The LeukoStrat CDx FLT3 Mutation Assay is used as a tool to evaluate patients with AML who are considering treatment with gilteritinib fumarate (United States, Europe and Japan ).

The LeukoStrat CDx FLT3 mutation assay is used as a tool to evaluate patients with AML who are considering treatment with quizartineib hydrochloride ( Japan ).

The globally standardized test includes software that interprets data and determines the respective mutant / wild-type signal quotient for ITD and TKD mutations. This extensively tested assay helps standardize the discovery of genetic mutations in the FLT3 gene, which is one of the major causes of mutations in acute myeloid leukemia (AML).