On January 6, 2019 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported an update on its business performance, including preliminary net product sales results for 2018, and key clinical development programs for 2019 (Press release, Neurocrine Biosciences, JAN 6, 2019, View Source [SID1234532491]). Kevin Gorman, Chief Executive Officer of Neurocrine, will discuss these updates as part of a webcast presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, Jan. 7 at 2:30 p.m. PT (5:30 p.m. ET).

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"Our fourth quarter and 2018 results reflect the dedication of our team in educating healthcare providers about tardive dyskinesia and the benefit INGREZZA can bring to patients. We still have a lot of work to do as many people suffering from tardive dyskinesia remain undiagnosed and untreated, and we remain committed to helping the lives of patients through our recently expanded field sales team and disease awareness education," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2019, we will remain focused on reaching more patients with INGREZZA and making progress in our clinical development programs, including the planned submission of AbbVie’s new drug application for uterine fibroids and our planned submission for Parkinson’s disease, as well as advancing our congenital adrenal hyperplasia program."

Preliminary Fourth Quarter and Full-Year 2018 Net Product Sales Results (Unaudited)

Based on preliminary unaudited financial information, the Company expects net product sales for the three months and full-year ended December 31, 2018 to be approximately $130 million and $409 million, respectively, compared to $64.5 million and $116.6 million for the same periods in 2017.

2019 Expected Milestones

INGREZZA (valbenazine) for Tardive Dyskinesia

"Talk About TD" disease state awareness campaign
Execution of post-marketing clinical studies, including RE-KINECT, the largest real-world study in patients with possible tardive dyskinesia
Presentations at key scientific annual meetings, including American Academy of Neurology (AAN), American Psychiatric Association (APA), International Parkinson and Movement Disorder Society (MDS)
Elagolix in Collaboration with AbbVie

Continued launch of ORILISSA (elagolix) to treat endometriosis by AbbVie
Elagolix for uterine fibroids: planned 2019 New Drug Application (NDA) submission
Opicapone for Parkinson’s Disease

NDA submission in Q2 2019
Preparation for 2020 opicapone commercial launch
Presentations at key scientific annual meetings, including AAN, MDS
Congenital Adrenal Hyperplasia (CAH)/NBI-74788 (In Development)

Phase IIa data for CAH (adults) in Q1 2019
Phase IIa initiation for CAH (pediatric) in Q2/Q3 2019
Pivotal study initiation for CAH (adults) in 2H 2019, pending U.S. Food and Drug Administration (FDA) discussion in Q2
Early Stage Programs

Investigational New Drug submission and initiation of a Phase I trial for a new, internally discovered program
About INGREZZA (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso, and/or other body parts.

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine’s laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.

Important Safety Information

Contraindications
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

Warnings & Precautions
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

On January 5, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that Giovanni Caforio, M.D., chairman and chief executive officer, will join Mark Alles, chairman and chief executive officer of Celgene, for a fireside chat at the 37th Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET) on Monday, January 7, 2019 at the Westin St. Francis in San Francisco (Press release, Bristol-Myers Squibb, JAN 5, 2019, View Source [SID1234532483]).

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Investors and the general public are invited to listen to a live webcast of the presentation at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the presentation will be available later that day.

On January 5, 2019 NantKwest (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of the human immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases reported that the company will be hosting an Investor/Analyst Day on Tuesday, January 8, 2019 in San Francisco, California (Press release, NantKwest, JAN 5, 2019, View Source [SID1234532486]).

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NantKwest will be sharing with analysts and investors a review of the company’s activities in 2018 and provide an overview for 2019.

At this event, senior management of NantKwest will provide a review of its ongoing R&D program, as well as provide a roadmap for the company’s clinical programs for 2019.

The event will begin at 7:00 PM PT on Tuesday, January 8, 2019 and is expected to conclude at 9:00 PM PT. A replay of the presentation will be posted on the NantKwest website and will be available for 30 days following the event

On January 4, 2019 Alder BioPharmaceuticals, Inc. reported that it has entered into a Distribution Agreement (the "Distribution Agreement") with J.P. Morgan Securities LLC, as our sales agent (the "Sales Agent"), pursuant to which we may offer and sell from time to time through the Sales Agent up to $100,000,000 maximum aggregate offering price of our common stock, par value $0.0001 per share ("Common Stock"), in such amounts as we may specify by notice to the Sales Agent, in accordance with the terms and conditions set forth in the Distribution Agreement (Filing, 8-K, Alder Biopharmaceuticals, JAN 4, 2019, View Source [SID1234532445]).

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Sales, if any, of the Common Stock pursuant to the Distribution Agreement may be made in negotiated transactions or transactions that are deemed to be "at-the-market" offerings as defined in Rule 415 under the Securities Act, including sales made directly on the Nasdaq Stock Market, or sales made to or through a market maker other than on an exchange. Under the Distribution Agreement, we will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. We are not obligated to sell any Common Stock under the Distribution Agreement. The Common Stock will be offered and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-216199) which was automatically effective upon filing with the Securities and Exchange Commission on February 23, 2017. We may terminate the Distribution Agreement upon written notice to the Sales Agent for any reason or by the Sales Agent upon written notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in our company.

The Distribution Agreement contains customary representations, warranties and agreements by us, and indemnification rights and obligations of the parties. The Distribution Agreement provides that the Sales Agent will be entitled to compensation for its services equal up to 3.0% of the gross sales price per share of all shares sold through the Sales Agent under the Distribution Agreement. Under the terms of the Distribution Agreement, we have agreed to indemnify the Sales Agent against certain specified types of liabilities, including liabilities under the Securities Act of 1933, as amended, to contribute to payments the Sales Agent may be required to make in respect of these liabilities, and to reimburse the Sales Agent for certain expenses. In the ordinary course of business, the Sales Agent or their respective affiliates from time to time have provided and may in the future provide various investment banking, commercial banking and financial advisory services to the company and/or its affiliates, for which they have received or may receive customary compensation.

We intend to use the net proceeds from the sale, if any, of the securities offered in the offering for the commercialization of eptinezumab up to and through launch and the manufacture of commercial supply for eptinezumab, and may also use net proceeds for future eptinezumab clinical trials, the development of ALD1910 and for working capital and general corporate purposes.

The above summary of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, a copy which is attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference. The legal opinion of Cooley LLP relating to the shares of Common Stock being offered pursuant to the Distribution Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

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

On January 4, 2019 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 2019, which ended November 30, 2018 (Press release, AngioDynamics, JAN 4, 2019, View Source [SID1234532464]).

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"We are very pleased with our second quarter financial results, which are marked by growth across all of our business segments, expanding gross margins, and improved profitability. Our quarterly performance was positively impacted by our recent acquisitions, validating our portfolio optimization strategy and enhancing our value proposition within oncology. In addition, we continue to make progress toward obtaining a pancreatic cancer indication for NanoKnife and recently received notification from the FDA that NanoKnife will be considered a Category B IDE once we receive approval to begin our DIRECTtm NanoKnife study for Stage III pancreatic cancer," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We are encouraged by these accomplishments and are well positioned to achieve our financial targets for the full year."

Second Quarter 2019 Financial Results

Net sales for the second quarter of fiscal 2019 were $91.5 million, an increase of 5.5%, compared to $86.7 million a year ago. During the quarter, each of the Company’s three businesses posted growth, led by the Oncology business.

Currency did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $15.3 million, an increase of 19.8% from $12.8 million a year ago, as strong NanoKnife sales in both capital and disposables and positive contributions from the two recent acquisitions more than offset decreased sales of the Company’s Thermal Ablation products. The comparison of year-over-year results within the Company’s Oncology business was negatively impacted by the timing of the prior-year Acculis Microwave ablation system market withdrawal. Excluding the impact of this transition from the Company’s Acculis Microwave product to its Solero Microwave product, the Oncology business grew 28.7% year over year.
Vascular Interventions and Therapies net sales in the second quarter of fiscal 2019 were $52.5 million, an increase of 2.2%, compared to $51.4 million a year ago, as strong growth in Fluid Management and AngioVac were partially offset by a decelerating decline in the Venous Insufficiency business.
Vascular Access net sales were $23.7 million, an increase of 5.1% from $22.6 million a year ago, as strong sales of Ports and Dialysis products were slightly offset by a decline in sales of PICCs.
U.S. net sales in the second quarter of fiscal 2019 were $71.9 million, an increase of 5.2% from $68.3 million a year ago, and International net sales were $19.6 million, an increase of 6.6% from $18.4 million a year ago.

Gross margin for the second quarter of fiscal 2019 expanded 440 basis points to 53.7% from 49.3% a year ago, consistent with the trending improvements related to the Company’s core operational enhancements, as well as higher gross margins associated with our portfolio optimization strategy.

The Company recorded net income of $2.1 million, or $0.06 per share, in the second quarter of fiscal 2019. This compares to net income of approximately $0.2 million, or $0.01 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 2019 was $8.4 million, or $0.22 per share, compared to adjusted net income of $6.3 million, or $0.17 per share, in the second quarter of fiscal 2018.

Adjusted EBITDAS in the second quarter of fiscal 2019, excluding the items shown in the reconciliation table below, was $16.3 million, compared to $13.3 million in the second quarter of fiscal 2018.

In the second quarter of fiscal 2019, the Company generated $13.0 million in operating cash flow and had capital expenditures of $0.7 million. As of November 30, 2018, the Company had $42.8 million in cash and cash equivalents and $145.0 million in debt, excluding the impact of deferred financing costs.

Six Months Financial Results

For the six months ended November 30, 2018:

Net sales were $176.8 million, an increase of 2.7%, compared to $172.1 million for the same period a year ago.
The Company’s net income was $1.7 million, or $0.04 per share, compared to net income of $0.2 million, or $0.01 per share, a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $14.6 million, or $0.38 per share, compared to adjusted net income of $11.3 million, or $0.30 per share, a year ago.
Adjusted EBITDAS, excluding the items shown in the reconciliation table below, was $28.9 million, compared to $24.6 million for the same period a year ago.
Fiscal Year 2019 Financial Guidance

The Company reiterates its previously announced financial guidance, continuing to expect fiscal year 2019 net sales in the range of $354 to $359 million and free cash flow in the range of $26 to $31 million. Additionally, the Company continues to expect adjusted earnings per share in the range of $0.82 to $0.86.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its second quarter 2019 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13685683.

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 Friday, January 4, 2019, until 11:59 p.m. ET on Friday, January 11, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13685683.

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 EBITDAS, adjusted net income, adjusted earnings per share and free cash flow. 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.