On February 20, 2020 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its fourth quarter and year end 2019 financial results after market close on Thursday, February 27, 2020 (Press release, Rigel, FEB 20, 2020, View Source [SID1234554584]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results.

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Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

On February 20, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, President and Chief Executive Officer, will present at the upcoming investor conferences (Press release, Arena Pharmaceuticals, FEB 20, 2020, View Source [SID1234554583]):

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SVB Leerink 9th Annual Global Healthcare Conference – Presenting on Tuesday, February 25, at 3:00 PM ET, in New York City
Cowen and Company 40th Annual Healthcare Conference – Presenting on Wednesday, March 4, at 10:40AM ET, in Boston
A live audio webcast of the presentations will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

On February 20, 2020 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its fourth quarter and year-to-date 2019 financial results on Thursday, February 27, 2020, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, FEB 20, 2020, View Source [SID1234554582]). 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 Thursday, February 27, 2020. 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 4783883.

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 4783883.

On February 20, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter and full year ended Dec. 31, 2019 (Press release, NuVasive, FEB 20, 2020, View Source [SID1234554581]).

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Fourth Quarter 2019

Revenue increased 7.6% to $310.4 million, or 7.8% on a constant currency basis;
GAAP operating margin of 13.6%; Non-GAAP operating margin of 16.4%; and
GAAP diluted earnings per share of $0.55; Non-GAAP diluted earnings per share of $0.73.
Full Year 2019

Revenue increased 6.0% to $1.168 billion, or 6.6% on a constant currency basis;
GAAP operating margin of 10.5%; Non-GAAP operating margin of 15.8%; and
GAAP diluted earnings per share of $1.23; Non-GAAP diluted earnings per share of $2.47.
"NuVasive delivered strong financial results in 2019 with consistent, above-market growth of 6.0% over prior year," said J. Christopher Barry, chief executive officer of NuVasive. "In 2020, our primary growth drivers include continuing to lead in lateral spine surgery, further innovation in targeted spine segments and achieving scale in key global markets to drive value and deliver on our long-term commitments."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Fourth Quarter 2019 Results
NuVasive reported fourth quarter 2019 total revenue of $310.4 million, a 7.6% increase compared to $288.3 million for the fourth quarter 2018. On a constant currency basis, fourth quarter 2019 total revenue increased 7.8% compared to the same period last year.

For the fourth quarter 2019, both GAAP and non-GAAP gross profit was $227.1 million and GAAP and non-GAAP gross margin was 73.2%. These results compared to GAAP and non-GAAP gross profit of $202.2 million and GAAP and non-GAAP gross margin of 70.1%, for the fourth quarter 2018.

The Company reported GAAP net income of $29.9 million, or diluted earnings per share of $0.55, for the fourth quarter 2019 compared to GAAP net income of $12.2 million, or diluted earnings per share of $0.23, for the fourth quarter 2018. On a non-GAAP basis, the Company reported net income of $38.5 million, or diluted earnings per share of $0.73, for the fourth quarter 2019 compared to non-GAAP net income of $36.1 million, or diluted earnings per share of $0.69, for the fourth quarter 2018.

Full Year 2019 Results
NuVasive reported full year 2019 total revenue of $1.168 billion, a 6.0% increase compared to $1.102 billion for the full year 2018. On a constant currency basis, full year 2019 total revenue increased 6.6% compared to the full year 2018.

For the full year 2019, both GAAP and non-GAAP gross profit was $855.7 million and GAAP and non-GAAP gross margin was 73.3%. These results compared to GAAP and non-GAAP gross profit of $790.6 million and $791.6 million, respectively, and GAAP and non-GAAP gross margin of 71.8% and 71.9%, respectively, for the full year 2018. For the full year 2019, GAAP and non-GAAP operating expenses were $732.7 million and $670.7 million, respectively. These results compared to GAAP and non-GAAP operating expenses of $736.4 million and $624.8 million, respectively, for the full year 2018.

The Company reported GAAP net income of $65.2 million, or diluted earnings per share of $1.23, for the full year 2019 compared to GAAP net income of $12.5 million, or diluted earnings per share of $0.24, for the full year 2018. On a non-GAAP basis, the Company reported net income of $129.8 million, or diluted earnings per share of $2.47, for the full year 2019 compared to non-GAAP net income of $116.6 million, or diluted earnings per share of $2.23, for the full year 2018.

Annual Financial Guidance for 2020
The company estimates full year 2020 revenue growth to be in the range of 4.0% to 6.0%, GAAP diluted earnings per share in the range of $1.15 to $1.25 and non-GAAP diluted earnings per share in the range of $2.55 to $2.65.

On February 20, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the full fiscal year ended December 31, 2019 (Press release, VolitionRX, FEB 20, 2020, View Source [SID1234554580]). Volition management will host a conference call tomorrow, February 21, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During 2019, we, together with our collaborators, have made very strong progress, particularly in assay and platform development, with our Nu.Q(TM) Capture program and epigenetic toolkit, Nu.Q(TM) Vet in collaboration with Texas A&M University and, most recently, with the acquisition of the epigenetics reagents company, Octamer GmbH. It is very encouraging that our field of epigenetics is now getting what we believe is long overdue recognition."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer.

Mr. Reynolds added "We strengthened our balance sheet throughout 2019 with existing investors exercising over $16 million in outstanding warrants to purchase shares of our common stock, receipt of additional non-dilutive funding and maintaining a low cash burn rate and therefore start the new year in a strong position to achieve our key 2020 milestones."

Company Highlights

Financial

Cash and cash equivalents as of December 31, 2019 totalled $17 million compared to $13.4 million as of the end of 2018.
Existing investors exercised $16.5 million in aggregate amount of outstanding warrants to purchase shares of our common stock.
Received additional $3.3 million in non-dilutive funding taking our total non-dilutive funding (grants and loans) to date to over $7.5 million.
Continue to manage cash carefully with a monthly burn (or cash used in operating activities) of approximately $1.2 million during 2019.
Assay Development

Volition has completely re-engineered its Nu.Q(TM) assays to now use a magnetic particle-based assay format leading to a step-change improvement in analytical performance. Volition expects this enhanced analytical performance to translate into improved clinical performance in the studies to be carried out and reported in the coming months.

Relative to Volition’s ELISA plate Nu.Q(TM) assay format, the magnetic particle-based assay format demonstrates:

A 10 to 20-fold improvement in analytical sensitivity of the assays.
Typical within-day reproducibility of quantitative test results below 3% (previously <10%).
Decrease in test result turnaround time from 6 hours to approximately 1 hour and 20 minutes, allowing much higher throughput.
The ability to be developed and processed on fully-automated Random-Access platforms (enabling the use of a wide range of commercial automated platforms).
In terms of clinical accuracy, over the past twelve months as we have been working on the aforementioned assay development, we have completed some proof of concept studies to assess clinical performance. While this work is yet to be completed for the finalized assays, preliminary results were extremely encouraging that for even the development assays we saw our highest ever Area Under the Curve performance in Blood Cancer at 91% and in Lung Cancer at 85% in addition to reporting positive data in colorectal cancer.

Epigenetic Toolbox

Volition has developed and is seeking patents on its novel Nu.Q(TM) Capture based epigenetic tools, in addition to its ongoing efforts regarding its bead-based Nu.Q(TM) assay format, to decipher the epigenetic and environmental profiles of cancer nucleosomes with the aim of using:

Nu.Q(TM) Capture methods to enrich cancer nucleosomes and simplify sequencing based "liquid biopsies".
Nu.Q(TM) Capture methods to isolate intact nucleosomes from plasma for mass spectrometry analysis in the framework of both biomarker discovery and clinical diagnostics.
Nu.Q(TM) Capture to measure global methylation patterns in a simple platform.
Nu.Q(TM) Capture to concentrate nucleosomal markers prior to our Nu.Q(TM) assays to increase accuracy.
Nu.Q(TM) platform to detect and measure circulating nucleosomes and transcription factors with potential to be tissue specific, and therefore cancer specific. This, if successful could result in a simple blood test for multiple cancers.
Volition is using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, to a broader and potentially more powerful investigation of the epigenetic status of a patient’s circulating chromosome fragments, in addition to its ongoing work with its assay-based format in a range of cancers.

Organization

Our laboratory team expanded appreciably to include, among others, the appointment of an Assay Validation Expert who has been instrumental in taking our assays forward.
We added two new operating subsidiaries with the formation of Volition Veterinary Diagnostics in June 2019 and the acquisition of our epigenetics reagents subsidiary, Octamer Gmbh, in the early part of 2020.
In connection with the formation of Volition Veterinary Diagnostics, we welcomed Nathan Dewsbury as its Chief Executive Officer and, Dr. Heather Wilson-Robles DVM, as its Chief Medical Officer.
In connection with the acquisition of Octamer we expanded our Scientific Advisory Board to include Dr. Adrian Schomburg, one of the world’s leading experts on Nucleosomes and founder and CEO of Octamer.
We also welcomed Dr. Phillip Barnes to our Board of Directors.
Upcoming Milestones

We expect to achieve the following milestones during 2020 :

Release a range of clinical data with our new optimised bead-based assays in colorectal, lung and other cancers.
Advance our previously announced large-scale colorectal and lung cancer trials in Europe, Asia and the U.S.
Advance the development of Nu.Q(TM) Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and/or sequencing.
Announce patient data demonstrating the wide utility of Volition’s epigenetic toolbox.
Complete pre-analytical and clinical studies for Nu.Q(TM) Vet with the aim of launching our first product in 2020.
Publish several abstracts and peer reviewed articles with clinical results as well as showing the robustness and utility of our Nu.Q(TM) platform.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected]

VolitionRx Limited Fourth Quarter & Full Year 2019 Earnings and Business Update Conference Call

Date: Friday, February 21, 2020
Time: 8:30 a.m. Eastern time
U.S. & Canada Dial-in: 1-877-407-9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201-493-6779
Conference ID: 13699351

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until March 6, 2020. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13699351.