On February 6, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its third quarter fiscal year 2020, ended December 31, 2019, at 4:15pm Eastern time on Monday, February 10, 2020 (Press release, Aethlon Medical, FEB 6, 2020, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-third-quarter-financial-results-and-host-conference-call-on-february-10-2020-301000019.html [SID1234553967]).

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Management will host a conference call on Monday, February 10, 2020 at 4:30pm eastern time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through February 17, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10139278.

On February 6, 2020 Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 13, 2020, to discuss the company’s fourth quarter and year-end 2019 financial results (Press release, Alkermes, FEB 6, 2020, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-fourth-quarter-and-year-end-2019-financial-results-301000560.html [SID1234553966]). Management will also discuss financial expectations for 2020 and provide an update on the company.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 13, 2020, through Thursday, Feb. 20, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13698323.

On February 6, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its second quarter ended December 31, 2019 (Press release, MEI Pharma, FEB 6, 2020, View Source [SID1234553965]).

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"We’re off to a good start in calendar year 2020. Our pipeline of clinical oncology candidates continues to advance, and the successful equity offering this past December gives us added resources to execute on our clinical strategy through key value-creating inflection points," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We have several important milestones across our pipeline in 2020 including completing enrollment in the ME-401 TIDAL study, data updates from the Phase 1b study of ME-401 administered as a monotherapy and in combination with other agents to treat patients with B-cell malignancies, one year survival data from the Phase 2 pracinostat study in patients with MDS, and voruciclib updates in patients with AML and B-cell malignancies."

Dr. Gold added, "We remain very encouraged by the ME-401 clinical program; the maturing data on the intermittent dosing schedule in the Phase 1b study continue to demonstrate high overall response rates and durable responses, and the intermittent schedule also continues to be well tolerated. Based on the strength of the data set from these intermittent schedule patients, the TIDAL study was amended to consolidate the remaining study enrollment into the intermittent dosing arm. We expect to complete enrollment in the TIDAL study this summer and plan a submission for accelerated approval with the FDA based on the results of this study."

Recent Highlights

In December 2019, the Company completed a public offering of common stock resulting in net proceeds to the Company of approximately $48.5 million.
In December 2019, the Company amended the study protocol for TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), the Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.
The amendment consolidates the remaining enrollment into the dosing arm in which patients receive ME-401 administered on the intermittent schedule ("IS").
The amendment was prompted by maturing data from the Phase 1b trial of ME-401 demonstrating that the IS regimen is as active as the continuous daily dosing regimen, is associated with durable responses to date, and is also associated with improved tolerability.
Approximately 120 patients will be enrolled in the IS arm and completion of enrollment is expected to complete in the summer of 2020.
In October 2019, the Company reported updated data from the ongoing Phase 1b study of ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta. The data demonstrate:
Overall response rates of 78% in relapsed or refractory FL and 89% in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma ("CLL/SLL").
Rates of Grade 3 adverse events of special interest related to ME-401 exposure were observed in <10% of patients dosed on an IS.
Median duration of response was not reached in patients with FL or CLL/SLL on the IS regimen. Median follow-up for FL and CLL/SLL patients was 9.2 months (range 3.4-20.7 months) and 7.4 months (range 2.6-14.7 months), respectively.
Fiscal Second-Quarter Fiscal Year 2020 Financial Results

As of December 31, 2019, MEI had $103.9 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the quarter ended December 31, 2019, cash used in operations was $10.5 million, compared to $7.2 million for 2018.
Research and development expenses were $8.3 million for the quarter ended December 31, 2019, compared to $9.1 million for 2018. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401.
General and administrative expenses were $4.2 million for the quarter ended December 31, 2019, compared to $3.8 million for 2018. The increase primarily relates to increased headcount and increased professional services expenses to support our activities.
Revenue was $1.0 million for the quarter ended December 31, 2019, compared to revenue of $2.0 million for the quarter ended December 31, 2018. Revenue resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin License Agreements. During the quarter ended December 31, 2018, revenue also included $0.9 million from transfer of the license to Kyowa Kirin.
Net loss was $20.2 million, or $0.26 per share, for the quarter ended December 31, 2019, compared to net income of $12.0 million, or $0.17 per share for 2018. Net loss increased primarily as a result of a non-cash expense in the current quarter and a non-cash gain in the prior quarter related to changes in the fair value of the warrant liability associated with the May 2018 financing. The Company had 105,998,677 shares of common stock outstanding as of December 31, 2019, compared with 71,131,486 shares as of December 31, 2018.
The adjusted net loss for the quarter ended December 31, 2019, excluding a non-cash expense related to changes in the fair value of the warrants (a non-GAAP measure), was $11.8 million, compared to an adjusted net loss of $11.4 million for 2018.

On February 6, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, February 13, 2020 to report its fourth quarter and full year 2019 financial results and provide a corporate update (Press release, Blueprint Medicines, FEB 6, 2020, View Source [SID1234553964]).

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To access the live conference call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international), and refer to conference ID 1240499. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On February 6, 2020 Mettler-Toledo International Inc. (NYSE: MTD) reported fourth quarter results for 2019 (Press release, Mettler-Toledo, FEB 6, 2020, View Source [SID1234553963]). Provided below are the highlights:

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Reported sales increased 3% compared with the prior year. In local currency, sales increased 4% in the quarter as currency reduced sales growth by 1%.
Net earnings per diluted share as reported (EPS) were $7.84, compared with $7.11 in the prior-year period. Adjusted EPS was $7.78, an increase of 14% over the prior-year amount of $6.85. Adjusted EPS is a non-GAAP measure, and we have included a reconciliation to EPS on the last page of the attached schedules.
Quarterly Results

Olivier Filliol, President and Chief Executive Officer, stated, "We had good sales growth in the quarter, particularly in light of the excellent growth in the prior year. Sales growth was strong in the Americas and China. With the benefit of our margin and productivity initiatives, we overcame meaningful currency and tariff headwinds to generate strong margin improvement and earnings growth in the quarter. Finally, we had excellent cash flow generation in the quarter and for the full year."

GAAP Results
EPS in the quarter was $7.84, compared with the prior-year amount of $7.11. EPS included a one-time, non-cash, deferred tax gain of $0.64, while prior year EPS included a one-time, non-cash, acquisition-related gain of $0.75.

Compared with the prior year, total reported sales increased 3% to $844.0 million. By region, reported sales increased 6% in the Americas and 4% in Asia/Rest of World. Reported sales in Europe declined by 1%. Earnings before taxes amounted to $231.1 million, compared with $230.5 million in the prior year. Earnings before taxes in the prior year included a one-time, non-cash, acquisition-related gain of $18.7 million.

Non-GAAP Results
Adjusted EPS was $7.78, an increase of 14% over the prior-year amount of $6.85.

Compared with the prior year, total sales in local currency increased 4% as currency reduced reported sales growth by 1%. By region, local currency sales increased 6% in the Americas, 1% in Europe and 5% in Asia/Rest of World. Adjusted Operating Profit amounted to $256.3 million, a 7% increase from the prior-year amount of $239.7 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Full Year Results

GAAP Results
EPS in 2019 was $22.47, compared with the prior-year amount of $19.88. EPS included a one-time, non-cash, deferred tax gain of $0.63, while prior year EPS included a one-time, non-cash, acquisition-related gain of $0.74.

Compared with the prior year, total reported sales increased 2% in 2019 to $3.009 billion. By region, reported sales increased 5% in the Americas and 3% in Asia/Rest of World. Reported sales in Europe declined 2%. Earnings before taxes amounted to $681.4 million, compared with $651.9 million in the prior year. Earnings before taxes in the prior year included a one-time, non-cash, acquisition-related gain of $18.7 million.

Non-GAAP Results
Adjusted EPS in 2019 was $22.77, an increase of 12% over the prior-year amount of $20.32.

Compared with the prior year, total sales in local currency increased 5% as currency reduced reported sales growth by 3%. By region, local currency sales increased 6% in the Americas, 3% in Europe and 6% in Asia/Rest of World. Adjusted Operating Profit amounted to $778.1 million, a 7% increase from the prior-year amount of $730.5 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Outlook

The Company said that based on its assessment of market conditions today, management anticipates local currency sales growth in 2020 will be approximately 4%. This sales growth is expected to result in Adjusted EPS in the range of $24.85 to $25.10, a growth rate of 9% to 10%. Management noted that local currency sales growth and Adjusted EPS guidance remains unchanged from previous guidance.

Management noted that they will face tough comparisons in the first quarter 2020 due to strong sales in the prior-year quarter and will face strong headwinds to Adjusted EPS due to adverse currency and the impact of tariff costs in the first quarter. In addition, based on today’s assessment, the Company expects a significant impact on its China sales in the first quarter due to the Wuhan Coronavirus.

Based on market conditions today, the Company anticipates that local currency sales growth in the first quarter 2020 will be approximately 0% to 1%, and Adjusted EPS is forecasted to be in the range of $4.20 to $4.30, an increase of 2% to 5%.

While the Company has provided an outlook for local currency sales growth and Adjusted EPS, it has not provided an outlook for reported sales growth or EPS as it would require an estimate of currency exchange fluctuations and non-recurring items, which are not yet known. The Company noted in making its outlook that uncertainty remains in the macroeconomic environment and market conditions are subject to change.

Conclusion

Filliol concluded, "Demand in our markets remains solid with the exception of Food Retail and the potential short-term impact of the Wuhan Coronavirus. We continue to invest for growth via our investments in our field force, Spinnaker sales and marketing programs and new product development. We remain confident in executing on our growth, productivity and margin initiatives. We will monitor the macroeconomic environment as uncertainty exists in certain regions of the world, and remain agile and adapt if market conditions change. Based on market conditions today, we believe we can continue to gain share and deliver strong results in 2020."

Other Matters

The Company will host a conference call to discuss its quarterly results today (Thursday, February 6) at 5:00 p.m. Eastern Time. To hear a live webcast or replay of the call, visit the investor relations page on the Company’s website at www.mt.com/investors. The presentation referenced in the conference call will be located on the website prior to the call.