On February 21, 2019 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the fourth quarter and full year of 2018 before the market opens on Thursday, March 7, 2019 (Press release, ArQule, FEB 21, 2019, View Source [SID1234533535]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

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The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

On February 21, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CEO, Dr. David Giljohann, will present a corporate update at the 12th Annual European Life Sciences CEO Forum being held February 25-26, 2019 at the Hilton Zurich Airport Hotel in Zurich, Switzerland (Press release, Exicure, FEB 21, 2019, View Source [SID1234533552]). The presentation will occur on Monday, February 25, 2019 at 12:00 pm GMT+1.

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A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

On February 21, 2019 Integra LifeSciences Holdings Corporation (NASDAQ: IART) reported financial results for the fourth quarter and full year ended December 31, 2018, and issued its financial guidance for 2019 (Press release, Integra LifeSciences, FEB 21, 2019, View Source [SID1234533571]).

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Highlights:

Fourth Quarter 2018 Highlights

Reported revenue was $383.3 million, an increase of 4.0% over the prior year, while organic sales were higher by 4.4% over the prior year;

GAAP earnings per diluted share amounted to $0.29, compared to $0.56 in the prior year; fourth quarter adjusted earnings per diluted share amounted to $0.65, compared to $0.64 in the prior year;

Full-year 2018 Highlights

Reported revenue was $1,472.4 million, an increase of 23.9% over the prior year, which represents the fifth consecutive year of double-digit growth in reported revenue; organic sales were higher by 4.3% over the prior year;

GAAP earnings per diluted share amounted to $0.72, a 12.2% decrease over the prior year; full-year adjusted earnings per diluted share amounted to $2.42, a 24.7% increase over the prior year, which represents the fifth consecutive year of double-digit growth in adjusted earnings per share;

2019 Company Guidance

The Company expects full-year 2019 reported revenue in the range of $1.515 billion to $1.525 billion, representing 3.5% growth at the midpoint; organic revenue growth, which excludes the effect of foreign currency, acquisitions, divestitures and discontinued products, is expected to be approximately 5%; and

The Company expects full-year GAAP earnings per diluted share to be in the range of $1.36 to $1.43, and full-year adjusted earnings per diluted share to be in the range of $2.65 to $2.72.

Total revenues for the full-year 2018 were $1,472.4 million, an increase of $284.2 million, or 23.9%, over the prior year. Total revenues for the fourth quarter were $383.3 million, an increase of $14.7 million, or 4.0%, over the fourth quarter of 2017.
Organic revenues for the full-year 2018 increased 4.3% over the prior year, while fourth quarter organic revenues were higher by 4.4% over the fourth quarter of 2017.
"We are pleased to report fourth quarter sales and adjusted earnings per share at the high end of our guidance range," said Peter Arduini, Integra’s President and Chief Executive Officer. "In 2018, we completed much of the work associated with the integration of Codman and the expansion of our commercial organizations. We look forward to launching over ten new products in 2019 and leveraging our more focused sales channels to accelerate organic growth."
The Company reported GAAP net income of $60.8 million, or $0.72 per diluted share, for the full-year 2018, compared to GAAP net income of $64.7 million, or $0.82 per diluted share, in 2017.
The Company reported GAAP net income of $25.1 million, or $0.29 per diluted share, in the fourth quarter of 2018, compared to GAAP net income of $44.4 million, or $0.56 per diluted share, in the fourth quarter of 2017. The decline is due to a 2017 benefit relating to deferred tax rate changes associated with the U.S. Tax Cut and Jobs Act.
Adjusted EBITDA for the full year 2018 was $342.1 million, an increase of $72.6 million over the prior year. For the full-year 2018, adjusted EBITDA as a percentage of revenue increased to 23.2% from 22.7% in 2017, largely attributable to the accretion from the acquired Codman business and better G&A leverage.
Adjusted EBITDA for the fourth quarter of 2018 was $88.8 million, roughly flat compared to the fourth quarter of the prior year. For the fourth quarter of 2018, adjusted EBITDA as a percentage of revenue was 23.2%, compared to 24.1% in the prior year period. The decline was largely due to commercial investments made in 2018 to expand our commercial channels in both segments.
Adjusted net income for the full-year 2018 was $203.5 million, or $2.42 per diluted share, compared to $153.4 million, or $1.94 per diluted share, in 2017. Adjusted net income for the fourth quarter of 2018 was $56.2 million, or $0.65 per diluted share, compared to adjusted net income of $51.0 million, or $0.64 per diluted share, in the fourth quarter of 2017.
For the year ended December 31, 2018, cash flows from operations totaled $199.7 million. Capital expenditures were $77.7 million. Adjusted free cash flow conversion for the trailing twelve months ended December 31, 2018 was 59.9% versus 46.3% for the twelve months ended December 31, 2017, mostly as a result of accretion from the acquired Codman business and lower integration costs in 2018. In the fourth quarter of 2018, the Company generated $42.7 million of cash flows from operations and incurred capital expenditures of $25.7 million.

2019 Financial Guidance

The Company is issuing full-year 2019 total revenue guidance in the range of $1.515 billion to $1.525 billion, representing organic growth of approximately 5%.
The Company expects GAAP earnings per diluted share for the full year to be between $1.36 and $1.43 and adjusted earnings per diluted share to be in the range of $2.65 to $2.72.
"We expect faster organic growth in the second half of 2019, averaging about 5% for the full year," said Glenn Coleman, Chief Financial Officer. "By mid-year we will move past the anticipated disruption associated with the transition of the Codman business outside the U.S. Moreover, in the second half of the year, we should benefit from new product introductions and improved sales force effectiveness."

In the future, the Company may record, or expects to record, certain additional revenues, gains, expenses or charges as described in the Discussion of Adjusted Financial Measures below that it will exclude in the calculation of organic revenue growth, adjusted EBITDA and adjusted EPS for historical periods and in providing adjusted EPS guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET today, Thursday, February 21, 2019 to discuss fourth quarter and full-year 2018 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.
Access to the live call is available by dialing 334-323-0522 and using the passcode 2673263. The call can also be accessed through a webcast via a link provided on the Investor Relations homepage of Integra’s website at investor.integralife.com. Access to the replay is available through February 26, 2019 by dialing 719-457-0820 and using the passcode 2673263. The webcast will also be archived on the website.

On February 21, 2019 Gamida Cell Ltd. (Nasdaq:GMDA), a leading cellular and immune therapeutics company, reported that new data from its NAM-NK and NiCord programs was presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant Research taking place in Houston, Texas (Press release, Gamida Cell, FEB 21, 2019, View Source [SID1234533623]). Data reported from the first 14 patients in the ongoing Phase 1 study of NAM-NK, an investigational, cell-based cancer immunotherapy, in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) demonstrated that NAM-NK was highly active, with three complete responses observed in patients with NHL and one complete response in a patient with MM. These data, along with additional safety data showing that NAM-NK was generally well tolerated, support continued clinical development. Gamida Cell is planning to initiate a multi-center, Phase 1/2 clinical study of NAM-NK in 2020. NAM-NK cells are natural killer cells that have been expanded using Gamida Cell’s proprietary nicotinamide-based, or NAM, technology.

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"I am encouraged by the emerging clinical profile of NAM-NK, and it is particularly exciting to witness complete responses in this heavily-pretreated patient population. Following treatment, two of the patients who were in complete remission received a bone marrow transplant, which has curative potential," stated M Health Hematologist/Oncologist Veronika Bachanova, M.D., Ph.D., Associate Professor of Medicine, Section Head for Malignant Hematology in the Division of Hematology, Oncology and Transplantation, University of Minnesota Medical School and Masonic Cancer Center member. "I look forward to continuing to evaluate the potential of NAM-NK as the study progresses."

Additionally, data were reported from the ongoing Phase 1/2 study of NiCord, an investigational advanced cell therapy designed to enhance and expand the life-saving benefits of hematopoietic stem cell (bone marrow) transplant, in patients with severe aplastic anemia. In the initial cohort of three patients, all three successfully underwent a stem cell transplant consisting of NiCord plus a haploidentical stem cell graft. The rapid engraftment, sustained hematopoiesis and accelerated immune recovery observed in these patients enable the initiation of a second cohort of patients to be treated with NiCord as a stand-alone graft.

"Data from our NiCord and NAM-NK programs continue to demonstrate the transformative potential of our proprietary nicotinamide-, or NAM-based, cell expansion technology. We are pleased to be at the forefront of exploring NK-therapy, which we believe has potential to advance treatment paradigms for patients just as CAR T therapy provided ground-breaking treatment options for patients," stated Julian Adams, Ph.D., chief executive officer at Gamida Cell. "We are also encouraged by the initial NiCord data in severe aplastic anemia, which supports further exploring a reduced intensity regimen and highlights the potential of NiCord as a bone marrow transplant solution not only for patients with hematologic malignancies but also for patients with severe bone marrow failure disorders. We look forward to continued progress with both programs throughout 2019."

NAM-NK Data in Patients with NHL and MM

The safety and activity of NAM-NK is currently being evaluated in a Phase 1 dose-escalation study. Patients received rituximab (NHL patients) or elotuzumab (MM patients) prior to and after NAM-NK infusion. The presentation, "First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer Cells for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma" (Poster #242), included six patients with NHL and eight patients with MM. All 14 patients were evaluable for safety, and 12 of 14 patients were evaluable for activity (all six NHL patients and six of eight MM patients). The majority of patients were heavily pre-treated and had advanced disease.

Among the six NHL patients, three patients achieved a complete response, one patient achieved a partial response, and two patients experienced progressive disease. Two of the patients who achieved a complete response subsequently received a bone marrow transplant. Among the six MM patients evaluable for activity, one patient achieved a complete response, two patients experienced stable disease, and three patients experienced progressive disease. Activity was observed at all three dose levels evaluated.

NAM-NK was generally well tolerated, with no graft vs. host disease (GvHD), no tumor lysis syndrome and no neurotoxicity syndrome observed. Grade 3 (n = 3) and Grade 4 (n = 1) hematologic adverse events were observed. Non-hematologic adverse events were mostly Grade 1 and Grade 2. There was one case of Grade 3 cytokine release syndrome and one death due to sepsis.

NiCord Data in Patients with Severe Aplastic Anemia

The safety and activity of NiCord in patients with severe aplastic anemia is being evaluated in an ongoing Phase 1/2 study. The presentation, "Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood Transplantation (UCB) for Refractory Severe Aplastic Anemia Results in Rapid Engraftment and Expedites Immune Recovery" (Poster #295), included data from three severe aplastic anemia patients with severe neutropenia who failed immunosuppressive therapy.

All three patients enrolled in the first cohort were successfully treated with reduced intensity conditioning regimens and underwent a bone marrow transplant consisting of NiCord plus a haploidentical stem cell graft. Engraftment occurred rapidly, with a median neutrophil recovery of 6 days (range: 6-7 days), which was sustained at day 100, and was superior to that observed in a retrospective cohort of 16 patients who received a single unexpanded umbilical cord blood transplant and haploidentical cells using the same conditioning regimen (P = 0.006). At median follow-up of 11 months (range 4-18 months), all three patients who received NiCord were alive and GvHD-free.

Conference Call Information

Gamida Cell will host a conference call and webcast today, Thursday, February 21, 2019, at 8:00 a.m. ET to review the data from its NAM-NK and NiCord programs that are being presented at the 2019 TCT Annual Meeting. A live webcast of the conference call can be accessed in the Investors section of Gamida Cell’s website at View Source To participate in the conference call, please dial 1-866-930-5560 (domestic) or 1-409-216-0605 (international) five minutes prior to start time. The conference ID number is 9462948. An archived version of the webcast will be available on Gamida Cell’s website for 30 days.

On February 21, 2019 Array BioPharma Inc. (Nasdaq: ARRY) reported that its Chief Executive Officer, Ron Squarer, will speak at the SVB Leerink Partners 8th Annual Global Healthcare Conference in New York (Press release, Array BioPharma, FEB 21, 2019, View Source [SID1234533536]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event: SVB Leerink Partners 8th Annual Global Healthcare Conference
Presenter: Ron Squarer, Chief Executive Officer, Array BioPharma
Date: Thursday, February 28, 2019
Time: 10:00 a.m. Eastern Time
Webcast: View Source

A replay of the presentation will also be accessible under the "Investors/Investor Calendar" section of the website at www.arraybiopharma.com.