On February 21, 2019 West Pharmaceutical Services, Inc. (NYSE: WST) reported that the Company’s Board of Directors has approved a second-quarter 2019 dividend of $0.15 per share (Press release, West Pharmaceutical Services, FEB 21, 2019, View Source [SID1234533570]). The dividend will be paid on May 1, 2019, to shareholders of record as of April 17, 2019.

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The Company also announced a share repurchase program authorizing the repurchase of up to 800,000 shares of the Company’s common stock from time to time on the open market or in privately-negotiated transactions as permitted under Securities Exchange Act of 1934 Rule 10b-18. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions. The share repurchase program is expected to be completed by December 31, 2019. The Company’s previously-authorized share repurchase program expired on December 31, 2018.

On February 21, 2019 Spectrum Pharmaceuticals (NasdaqGS: SPPI), reported it will host a conference call with management to discuss the fourth quarter and full year 2018 financial results, provide an update on the company’s business, and discuss expectations for the future on Thursday, February 28, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, FEB 21, 2019, View Source [SID1234533547]).

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Conference Call

Thursday, February 28, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 2797623
International: (973) 796-5077, Conference ID# 2797623

For interested individuals unable to join the call, a replay will be available from February 28, 2019 @ 7:30 p.m. ET/4:30 p.m. PT through March 7, 2019 until 11:59 p.m. ET/8:59 p.m. PT.

Domestic Replay Dial-In #: (855) 859-2056, Conference ID# 2797623
International Replay Dial-In #: (404) 537-3406, Conference ID# 2797623

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on February 28, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

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 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM), that it reported data from its Iomab-ACT program in a poster presentation at the 2019 Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR (TCT Meetings) (Press release, Actinium Pharmaceuticals, FEB 21, 2019, View Source [SID1234533531]). A series of preclinical studies demonstrated that targeting CD45 with an ARC or Antibody Radiation-Conjugate can achieve potent yet transient lymphodepletion in a safe and effective manner. These results support advancement of the Iomab-ACT program into human clinical trials to study it as a single-dose, outpatient lymphodepletion regimen, which is also referred to as conditioning, prior to administration of CAR-T and other adoptive cell therapies. This program has the potential of providing a superior means of conditioning that could displace or replace chemotherapy based conditioning regimens such as Flu/Cy or Fludarabine and Cyclophosphamide that are used as the standard of practice today. The ARC underpinning the Iomab-ACT program is a lower dose version of Actinium’s Iomab-B, which is in a pivotal Phase 3 trial for conditioning prior to a bone marrow transplant.

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Actinium’s preclinical studies showed that a single infusion of an anti-CD45 antibody labelled with Iodine-131 can effectively deplete greater than 90% of lymphocytes, including CD4 and CD8 T cells, CD19 B cells and NK cells, which is necessary for adoptive cell therapies like CAR-T to expand and persist. Tregs or regulatory T cells, including CD4+, CD25+ and FoxP3+ Tregs, which can exert negative pressure on cell therapy expansion and persistence, were suppressed for at least 21 days post lymphodepletion with Iomab-ACT. The multi-modal mechanism of action directed at CD45 expressing cells also depleted macrophages, which are implicated in the development of CRS or Cytokine Release Syndrome, and splenocytes while red blood cells, platelets, neutrophils and bone marrow stem cells were preserved. Additionally, MicroSPECT/CT imaging showed that Iomab-ACT homed to immune privileged sites including lymph nodes, spleen, liver and bone marrow. Finally, an in vivo animal model showed that adoptively transferred cytotoxic T cells persisted in mice following administration of CD45 targeted lymphodepletion and were able to control tumor cells compared to untreated mice.

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer said, "This data provides strong support for advancing the Iomab-ACT program into human clinical trials as a targeted conditioning regimen for lymphodepletion prior to CAR-T or adoptive cell therapy. Targeted lymphodepletion with Iomab-ACT has the potential to create an optimal immune homeostatic environment for cell therapies to expand and persist leading to stronger and more durable responses. It is validating of our initial premise that lymphodepletion was achieved with non-myeloablative doses that spared neutrophils, platelets, red blood cells and bone marrow stem cells, as this could lead to a stronger patient that is able to better withstand treatment with cell therapies, which could also improve patient outcomes and also expand the number of patients eligible for these therapies. To achieve this with a single-infusion, outpatient administration would be an exciting advancement for the field of CAR-T and adoptive cell therapies and for patients that could benefit from them. We look forward to the next phase of development of this program."

Actinium’s Iomab-ACT program is an ARC that targets CD45. CD45 is an antigen expressed on many cells that are relevant to CAR-T including lymphocytes, regulatory T cells and macrophages that have been associated with CAR-T challenges such as durability of response, CRS and neurotoxicity. Iomab-ACT is derived from, and is a lower dose of, Actinium’s lead program Iomab-B, which has been studied in over 300 patients and is currently being investigated in a pivotal Phase 3 trial for targeted conditioning prior to a BMT or Bone Marrow Transplant. Actinium’s Iomab-ACT program is highly differentiated when compared to Flu/Cy or other chemo-based lymphodepletion regimens. Unlike chemotherapy, its targeted nature is expected to improve CAR-T cell expansion more efficiently, potentially resulting in responses that are more durable and reduced CAR-T related toxicities. Also, the Iomab-ACT program enables lymphodepletion through a single-dose, outpatient administration versus Flu/Cy or other chemo-based lymphodepletion regimens that require multiple infusions in an inpatient setting over several days. Because of this potentially superior profile, the Iomab-ACT technology could result in improved access to CAR-T therapy and also better outcomes. A webinar highlighting the Iomab-ACT program can be accessed here.

Sandesh Seth, Actinium’s Chairman and CEO said, "The TCT meetings are the ideal venue to showcase this exciting new data and we are excited to have had the opportunity to present it to thought leading physicians and industry leaders that are advancing the field of cellular therapy. These data are the catalyst enabling advancement into the clinic with the first single-dose, outpatient targeted conditioning program for lymphodepletion and also support our collaborative efforts. With recently filed IP and now this new data, we are excited to see Iomab-ACT advancing in tandem with other programs in our targeted conditioning portfolio including our pivotal programs Iomab-B and Actimab-MDS. Clearly, at the TCT Conference, this poster and our other activity is gaining recognition that we are building a highly differentiated, industry leading portfolio in targeted conditioning that has value in serving major unmet or underserved medical needs."