On January 7, 2020 Avidity Biosciences (Avidity) announced today that it will present at the 38th Annual J.P. Morgan Healthcare Conference being held January 13-16, 2020 in San Francisco, CA (Press release, Avidity Biosciences, JAN 7, 2020, View Source [SID1234552817]).

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Sarah Boyce, President and CEO of Avidity, will present an overview of the company’s novel approach to treating rare muscle disorders and other serious diseases using Avidity’s proprietary Antibody-Oligonucleotide Conjugates (AOCs). Avidity’s AOCs combine the tissue selectivity of monoclonal antibodies with the specificity of oligonucleotide-based therapeutics to modulate disease-related RNAs in many cell types and tissues. This presentation follows the close of a successful $100 million Series C in 2019 that will fund development activities and expansion of the Avidity platform to other tissues and organs.

Presentation details are below:

Date: Wednesday, January 15th, 2020
Time: 10:30 am PT
Location: The Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA

On January 7, 2020 Pfizer Inc. (NYSE: PFE) reported investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 3:30 p.m. Pacific Standard Time (Press release, Pfizer, JAN 7, 2020, View Source [SID1234552784]).

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To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today.

On January 7, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the second quarter of fiscal year 2020, which ended November 30, 2019 (Press release, AngioDynamics, JAN 7, 2020, View Source [SID1234552800]).

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"Sales growth of 2.5%, ex-Asclera, exhibited continued momentum during the quarter, and I am pleased with the resulting gross margin expansion and profitability," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We are making excellent progress on the integration of Eximo Medical and are currently building out a dedicated commercial organization to support a product launch in the second half of our fiscal year 2020. I’m also excited to announce the acquisition of the C3 Wave tip location product, which will fill a technology gap in our portfolio and enable broader market adoption of our innovative BioFlo PICCs. Looking ahead, strong growth in sales of our AngioVac and NanoKnife products during the quarter should position us well to achieve our full-year guidance and drive growth across our portfolio."

Second Quarter 2020 Financial Results

Net sales for the second quarter of fiscal 2020, which now include the fiscal year 2019 acquisitions of BioSentry and RadiaDyne as organic revenue, were $70.0 million, flat compared to the prior-year quarter. Excluding the impact of Asclera sales, which were discontinued during fiscal year 2019, net sales grew 2.5% year over year. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $16.1 million, an increase of 5.1% from $15.3 million a year ago, led by higher sales of NanoKnife and the Alatus and IsoLoc balloon products.
Vascular Interventions and Therapies ("VIT") net sales were $31.2 million, an increase of 0.6%, compared to $31.0 million a year ago. Excluding last year’s Asclera sales of $1.7 million in the second quarter, VIT grew 6.5%, driven by growth in sales of the Company’s AngioVac and core VIT products.
Vascular Access net sales were $22.8 million, a decrease of 4.0% from $23.7 million a year ago, due primarily to lower sales of Ports and PICCs.
Excluding Asclera, U.S. net sales in the second quarter of fiscal 2020 were $55.6 million, an increase of 1.8% from $54.6 million a year ago, and International net sales were $14.4 million, an increase of 5.6% from $13.7 million a year ago.

Gross margin for the second quarter of fiscal 2020 was 59.3%, an increase of 140 basis points compared to the second quarter of fiscal 2019, driven primarily by productivity and supply chain improvements as well as positive product mix.

The Company recorded a net loss from continuing operations of $2.7 million, or a loss of $0.07 per share, in the second quarter of fiscal 2020. This compares to a net loss from continuing operations of approximately $3.6 million, or a loss of $0.10 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2020 was $2.2 million, or $0.06 per share, compared to adjusted net income of $2.9 million, or $0.07 per share, in the second quarter of fiscal 2019.

Adjusted EBITDA in the second quarter of fiscal 2020, excluding the items shown in the reconciliation table below, was $6.4 million, compared to $9.0 million in the second quarter of fiscal 2019.

In the second quarter of fiscal 2020, the Company used $5.9 million in operating cash and had capital expenditures of $2.6 million. As of November 30, 2019, the Company had $41.2 million in cash and cash equivalents and no debt outstanding.

Six Months Financial Results

For the six months ended November 30, 2019:

Net sales were $136.0 million, an increase of 1.6%, compared to $133.9 million for the same period a year ago. Excluding the impact of Asclera, sales of which were discontinued during fiscal year 2019, net sales grew 4.0% year over year.
The Company’s net loss from continuing operations was $4.0 million, or a loss of $0.11 per share, compared to a net loss from continuing operations of $9.3 million, or a loss of $0.25 per share, a year ago.
Gross margin improved 150 basis points to 58.6% from 57.1% a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $5.3 million, or $0.14 per share, compared to adjusted net income of $3.6 million, or $0.09 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $13.7 million, compared to $14.4 million for the same period a year ago.
C3 Wave PICC Tip Location Acquisition

Today, the Company announces the acquisition of the C3 Wave PICC tip location system from Medical Components Inc. This innovative, wireless, app-based ECG system eliminates the need for a confirmatory chest x-ray of PICC tip placement, allowing greater patient access to the Company’s proprietary BioFlo PICCs. The C3 Wave PICC tip location system has received FDA 510k, CE, Health Canada, and other international approvals.

Fiscal Year 2020 Financial Guidance

The Company reiterates its fiscal year 2020 guidance, which includes investments related to the full-market launch of the products acquired from Eximo anticipated in the second half of the fiscal year.

Specifically, the Company continues to expect net sales in the range of $280 to $286 million and gross margin in the range of 58% to 59%. Adjusted earnings per share is expected in the range of $0.10 to $0.15.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2020 second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13697417.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, January 7, 2020, until 11:59 p.m. ET on Tuesday, January 14, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13697417.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, free cash flow and net sales excluding Asclera. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On January 7, 2020 Amgen (NASDAQ:AMGN) reported that it will present via video conference at the Goldman Sachs 12th Annual Healthcare CEOs Unscripted Conference at 1 p.m. PT on Thursday, Jan. 9, 2020. Robert A. Bradway, chairman and chief executive officer at Amgen, and Peter H. Griffith, executive vice president and chief financial officer at Amgen, will presentv (Press release, Amgen, JAN 7, 2020, View Source [SID1234552818]). Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On January 7, 2020 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of its previously announced equity financing to issue 1,421,801 shares of newly designated Series A mandatorily convertible preferred stock to a lead institutional investor, at a price of $10.54 per share, and an aggregate of 1,137,442 shares of newly designated Series B mandatorily convertible preferred stock to BeiGene and Perceptive Advisors, at a price of $10.55 per share (Press release, Leap Therapeutics, JAN 7, 2020, View Source [SID1234553263]). The preferred stock price reflects a common stock equivalent price of $1.055 per share, the closing price for Leap’s common stock on the Nasdaq Global Market on the day of pricing, January 2, 2020 and, in the case of the Series A mandatorily convertible preferred stock, reflects a per share reduction equal to the exercise price of the pre-funded warrant issued upon conversion of the Series A mandatorily convertible preferred stock. The holder of Series A mandatorily convertible preferred stock also received a share of a newly designated special voting preferred stock that will entitle it to elect one member of Leap’s Board of Directors.

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Upon approval by the stockholders of Leap, the Series A mandatorily convertible preferred stock will automatically convert into pre-funded warrants to purchase 14,218,010 shares of common stock and the Series B mandatorily convertible preferred stock will automatically convert into 11,374,420 shares of common stock, plus that number of additional shares of common stock representing payment of an 8% per annum accruing dividend on each share of preferred stock as of the conversion date. Upon stockholder approval and conversion of the preferred stock, the investors will also receive warrants to purchase up to an equal number of shares of common stock at an exercise price of $2.11 per share. The aggregate gross proceeds to Leap from this offering are approximately $27 million, before deducting placement agent fees and estimated offering expenses payable by Leap, and excluding proceeds from the exercise of any warrants.

Raymond James & Associates, Inc. was the placement agent for the equity financing.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Leap has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.