Integra LifeSciences Reports First Quarter 2019 Financial Results

On April 24, 2019 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the first quarter ending March 31, 2019 (Press release, Integra LifeSciences, APR 24, 2019, View Source [SID1234535374]).
First Quarter 2019 Highlights

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Reported revenues were $359.7 million, an increase of 0.7% compared to the first quarter of 2018, and organic revenues increased 3.1% over the first quarter of 2018;

Reported revenues in the Codman Specialty Surgical segment decreased (0.7)% compared to the first quarter of 2018;

Reported revenues in the Orthopedics and Tissue Technologies segment increased 3.4% compared to the first quarter of 2018;

Foreign currency exchange rate changes negatively impacted reported revenues by $5.3 million in the first quarter of 2019;

GAAP gross margin was 64.2% and adjusted gross margin was 68.4%, an increase of 460 basis points and 180 basis points, respectively, compared to the first quarter of 2018;

GAAP earnings per diluted share were $0.38, compared to $0.14 in the first quarter of 2018;

Adjusted earnings per diluted share were $0.65, reflecting an increase of 12.1% over the first quarter of 2018;

The Company is reaffirming its revenue guidance for the full-year 2019, which includes total reported revenues of $1.515 billion to $1.525 billion and organic revenue growth of approximately 5%;

The Company is raising its GAAP earnings per diluted share to a new range of $1.46 to $1.53, from its prior range of $1.36 to $1.43, due to a one-time foreign tax benefit. The Company is reaffirming its adjusted earnings per diluted share of $2.65 to $2.72.

"We met our total revenue target and delivered better than expected profitability in the first quarter, while also achieving several significant milestones related to the Codman integration," said Peter Arduini, Integra’s president and chief executive officer. "We expect sequential improvements in our top line growth as we move past the disruption associated with the integration and ERP conversion and begin to benefit from multiple new product introductions."
The company reported GAAP net income of $32.8 million, or $0.38 per diluted share, in the first quarter of 2019, compared to GAAP net income of $11.0 million, or $0.14 per diluted share, in the first quarter of 2018. The increase in GAAP net income is a result of improved gross margins, lower acquisition and integration costs, lower interest expense and a one-time tax benefit in Switzerland.
Adjusted net income for the first quarter of 2019 was $56.4 million, an increase of 22.2% from the prior year’s first quarter. Adjusted earnings per diluted share for the first quarter of 2019 was $0.65, an increase of 12.1% over the prior year’s quarter.
Adjusted EBITDA for the first quarter of 2019 was $87.4 million, or 24.3% of revenue, compared to $83.2 million, or 23.3% of revenue, in the first quarter of 2018. This improvement was driven by higher gross margins, largely due to favorable product mix and manufacturing efficiencies.
2019 Full-Year Outlook
The Company is reaffirming its revenue guidance for the full-year 2019, which includes total reported revenues of $1.515 billion to $1.525 billion and organic revenue growth of approximately 5%. The Company is raising its GAAP earnings per diluted share to a new range of $1.46 to $1.53, from its prior range of $1.36 to $1.43, due to a one-time tax benefit. The Company is reaffirming its adjusted earnings per diluted share of $2.65 to $2.72.
"The strength of our gross margins contributed to adjusted earnings per share exceeding the high-end of our first quarter guidance range, and gives us increased confidence in our full-year 2019 targets," said Glenn Coleman, Chief Financial Officer.
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, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, April 24, 2019, to discuss financial results for the first quarter 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. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (855) 719-5012 and using the passcode 1392893. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through April 29, 2019 by dialing (888) 203-1112 and using the passcode 1392893. The webcast will also be archived on the website.

Fate Therapeutics Announces Five Presentations at the American Society of Gene & Cell Therapy 22nd Annual Meeting

On April 24, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Fate scientists and collaborators will present data highlighting the Company’s induced pluripotent stem cell (iPSC) product platform and its iPSC-derived cell product candidates at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 22nd Annual Meeting being held from April 28 – May 2, 2019 in Washington, D.C (Press release, Fate Therapeutics, APR 24, 2019, View Source [SID1234535357]).

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"Our strong scientific presence at ASGCT (Free ASGCT Whitepaper) demonstrates the unique value of our proprietary iPSC product platform for gene editing and the development of universal, off-the-shelf, engineered cell therapies," said Bob Valamehr, Ph.D., Chief Development Officer of Fate Therapeutics. "We look forward to showcasing the critical importance of characterizing and selecting a single clone from a heterogeneous population of engineered cells, our unmatched expertise in creating large numbers of clinical-grade NK cells and T cells from clonal master engineered iPSC lines, and the breadth of our highly-differentiated off-the-shelf cancer immunotherapy pipeline."

Three oral and two poster presentations will highlight several product candidates from the Company’s universal, off-the-shelf, iPSC-derived cancer immunotherapy pipeline, including NK cell product candidates FT500 for the treatment of advanced solid tumors and FT516 for the treatment of advanced hematologic malignancies. FT500 is the first-ever iPSC-derived cell therapy to be administered to patients in the U.S., and FT516 is the first-ever engineered iPSC-derived cell therapy allowed for clinical investigation in the world. The Company’s iPSC-derived, dual-targeted CD16-CAR19 NK cell product candidate FT596 and its iPSC-derived, TCR-less, TRAC-targeted, 1XX CAR19 T-cell product candidate FT819, which is being developed under a collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., will also be featured.

2019 ASGCT (Free ASGCT Whitepaper) Oral Presentations

Workshop – CAR T and Related Immune Effector Cell Therapies
Title: iPSC-Derived Immune Effector Cells
Presenter: Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center
Date and Time: Sunday, April 28, 2019, 3:30 PM – 6:00 PM
Location: Jefferson East
Session 132 – Induced Pluripotent Stem Cells
Title: Pluripotent Cell-Derived T and NK Cells as a Cornerstone Approach for Off-the-Shelf Cancer Immunotherapy
Presenter: Bob Valamehr, Ph.D., Chief Development Officer, Fate Therapeutics
Date and Time: Monday, April 29, 2019, 1:30 PM – 3:00 PM
Location: Monroe Room
Session 134 – NK Cells versus NKT Cells
Title: Clinical Development of NK Cell Cancer Therapy
Presenter: Sarah Cooley, M.D., Senior V.P., Clinical Translation, Fate Therapeutics
Date and Time: Monday, April 29, 2019, 1:30 PM – 3:00 PM
Location: Georgetown Room
2019 ASGCT (Free ASGCT Whitepaper) Poster Presentations

Poster 877 – iPSC Product Platform
Title: A Versatile Platform for Generation of Single-Cell Derived, Genetically Engineered, Fully Characterized Pluripotent Master Cell Lines as a Renewable Source for Off-the-Shelf Cell Therapy
First Author: Mochtar Pribadi, Ph.D., Scientist, Molecular Biology, Fate Therapeutics
Date and Time: Wednesday, May 1, 2019, 5:00 PM – 6:00 PM
Location: Columbia Hall
Poster 882 – CRISPR-based iPSC Generation
Title: A Novel Platform Combining Chemical and CRISPRa Approaches for the Generation of Human iPSCs
First Author: Jason Dinella, Ph.D., Scientist, Reprogramming Biology, Fate Therapeutics
Date and Time: Wednesday, May 1, 2019, 5:00 PM – 6:00 PM
Location: Columbia Hall
About FT500
FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. FT500 is being investigated in an open-label, repeat-dose Phase 1 clinical trial for the treatment of advanced solid tumors in up to 64 patients, both as a monotherapy and in combination with FDA-approved checkpoint inhibitor therapy. Despite the favorable response rates observed with checkpoint inhibitor therapy, the majority of patients do not respond and many responders relapse. One common mechanism of resistance to checkpoint inhibitor therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity (158V), non-cleavable CD16 (hnCD16) Fc receptor. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. CD16 occurs in two variants, either with high (158V) or low (158F) affinity for the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the CD16 high-affinity variant (approximately 15% of patients) have improved clinical outcomes. In addition, the expression of CD16 can undergo considerable down-regulation in cancer patients, which significantly inhibits the immune system’s anti-tumor response. FT516 incorporates a novel CD16 Fc receptor, which has been modified to prevent its down-regulation and augment its binding to tumor-targeting antibodies for enhanced ADCC. The Company announced in February 2019 that the FDA allowed its FT516 IND application for the treatment of relapsed / refractory hematologic malignancies including in combination with certain FDA-approved monoclonal antibody therapies.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

Surface Oncology Management to Present at the Solebury Trout Class of 2018 Biotech IPOs Investor Day

On April 24, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Jeff Goater, chief executive officer, will be participating and presenting a corporate update at the Solebury Trout Class of 2018 Biotech IPOs Investor Day, hosted together with Davis Polk and BMO Capital Markets (Press release, Surface Oncology, APR 24, 2019, View Source [SID1234535375]). The company will be closing the NASDAQ market as part of the conference on Thursday, April 25th.

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Presentation details:
Event: Solebury Trout Class of 2018 Biotech IPOs Investor Day
Date:Friday, April 26th
Time:9:30 AM ET
Location: Davis Polk Offices, New York, NY

A live and archived webcast of the presentation can be accessed by visiting the Investors page of the website at View Source

Thermo Fisher Scientific Reports First Quarter 2019 Results

On April 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 30, 2019 (Press release, Thermo Fisher Scientific, APR 24, 2019, View Source [SID1234535358]).

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First Quarter 2019 Highlights

First quarter revenue increased to $6.12 billion.
First quarter GAAP diluted earnings per share (EPS) increased 41% to $2.02.
First quarter adjusted EPS increased 12% to $2.81.
Launched a range of new products, including two Thermo Scientific instruments for materials analysis – the Nicolet Summit FTIR spectrometer and the Helios 5 DualBeam scanning electron microscope – and in specialty diagnostics, received FDA clearance for a new ImmunoCAP test for peanut allergy.
Recently opened new Customer Solution Centers in Beijing and Delhi to help scientists in the food and beverage industry develop advanced analytical workflows that improve food quality and safety.
Announced $150 million expansion of our pharma services sites in Italy and North Carolina to increase capacity and capabilities of our global sterile manufacturing network and meet growing customer demand for biologics development and manufacturing services.
Announced agreement to acquire Brammer Bio, a leader in viral vector manufacturing, for $1.7 billion, significantly expanding our capabilities in the fast-growing gene and cell therapy market.
Repurchased $750 million of stock and increased our dividend by 12 percent.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We’re pleased to deliver another quarter of excellent growth on the top and bottom line," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our teams are strengthening our competitive position by successfully executing our growth strategy – a combination of launching great new products, leveraging our scale in high-growth and emerging markets, and enhancing our unique value proposition to be the strongest partner possible for our customers.

"I’m especially excited about our pending acquisition of Brammer Bio, which we announced in March. As a leader in viral vector manufacturing, Brammer Bio helps pharma and biotech customers deliver breakthrough gene and cell therapies to patients with rare diseases. We also continue to deploy capex to expand our pharma services capacity and capabilities in the U.S. and Europe to meet increasing customer demand and ultimately make a difference for countless patients and their families."

Casper added, "We’re off to a strong start, and we’re on track to deliver another outstanding year."

First Quarter 2019

Revenue for the quarter grew 5% to $6.12 billion in 2019, versus $5.85 billion in 2018. Organic revenue growth was 7%; acquisitions increased revenue by 1% and currency translation decreased revenue by 3%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2019 increased 41% to $2.02, versus $1.43 in the same quarter last year. GAAP operating income for the first quarter of 2019 grew to $0.92 billion, compared with $0.79 billion in the year-ago quarter. GAAP operating margin increased to 15.0%, compared with 13.4% in the first quarter of 2018.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2019 increased 12% to $2.81, versus $2.50 in the first quarter of 2018. Adjusted operating income for the first quarter of 2019 grew 7% compared with the year-ago quarter. Adjusted operating margin was 22.4%, compared with 22.0% in the first quarter of 2018.

2019 Guidance Update

Thermo Fisher is raising its 2019 revenue and earnings guidance to reflect strong operational performance and the acquisition of Brammer Bio, partially offset by a more adverse foreign exchange environment. The company is raising its revenue guidance to a new range of $25.17 to $25.47 billion versus its previous guidance of $24.88 to $25.28 billion. This would result in 3 to 5% revenue growth over 2018. The company is raising its adjusted EPS guidance to a new range of $12.08 to $12.22, versus its previous guidance of $12.00 to $12.20, for 9 to 10% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the first quarter of 2019, Life Sciences Solutions Segment revenue grew 7% to $1.61 billion, compared with revenue of $1.50 billion in the first quarter of 2018. Segment adjusted operating margin increased to 34.9%, versus 34.5% in the 2018 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 5% to $1.32 billion in the first quarter of 2019, compared with revenue of $1.26 billion in the first quarter of 2018. Segment adjusted operating margin increased to 21.3%, versus 19.6% in the 2018 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue increased 1% to $0.96 billion in the first quarter of 2019, compared with revenue of $0.95 billion in the first quarter of 2018. Segment adjusted operating margin was 25.3%, versus 25.6% in the 2018 quarter.

Laboratory Products and Services Segment

In the first quarter of 2019, Laboratory Products and Services Segment revenue grew 4% to $2.51 billion, compared with revenue of $2.41 billion in the first quarter of 2018. Segment adjusted operating margin was 11.3%, versus 11.6% in the 2018 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. Based on acquisitions closed through the end of the first quarter of 2019, adjusted EPS will exclude approximately $3.23 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 24, 2019, at 8:30 a.m. Eastern time. To listen, dial (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, May 10, 2019.

Blue Earth Diagnostics Announces Presentations on Axumin® (Fluciclovine F 18), 18F-Fluciclovine and 18F-rhPSMA at Upcoming American Urological Association’s 2019 Annual Meeting

On April 24, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported upcoming presentations at the American Urological Association’s 2019 Annual Meeting, AUA2019, being held May 3 – 6, 2019, in Chicago, Ill (Press release, Blue Earth Diagnostics, APR 24, 2019, View Source [SID1234535376]). Presentations on Axumin (fluciclovine F 18) Injection include additional analyses from the LOCATE clinical trial (NCT02680041), a prospective, U.S., multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging.

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Additional presentations include an investigational use of 18F-fluciclovine and initial clinical experience by the Technical University of Munich with 18F-rhPSMA-7, a Prostate Specific Membrane Antigen-targeted radiohybrid PET imaging agent representative of the family of rhPSMA agents that the company licensed in 2018. Details of the presentations to be made by Blue Earth Diagnostics collaborators are listed below.

AXUMIN (FLUCICLOVINE F 18) PRESENTATIONS
Date: Friday, May 3, 2019
Presentation: PET/CT with 18F-fluciclovine to predict recurrence in post-treatment prostate cancer and its role in altering treatment plans
Abstract Number: MP13-01
Presenter: Julio Chong, MD, Icahn School of Medicine at Mt Sinai, New York, NY
Session Title & Times: Prostate Cancer: Detection and Screening I – 1:00 – 3:00 p.m. CT
Location: MCP: W180

Date: Saturday, May 4, 2019
Presentation: Localization of recurrence of prostate cancer with 18F-fluciclovine positron emission tomography in patients with and without prior prostatectomy: Results from LOCATE
Abstract Number: MP36-18
Presenter: Gerald Andriole, Jr., MD, Washington University, St. Louis, Mo. on behalf of the LOCATE study group
Session Title & Times: MP36: Prostate Cancer: Detection and Screening V – 1:00 – 3:00 p.m. CT
Location: MCP: W180

Date: Monday, May 6, 2019
Presentation: Sites of prostate cancer recurrence delineated with 18F-fluciclovine positron emission tomography in patients with negative or equivocal conventional imaging
Abstract Number: PD60-12
Presenter: Gerald Andriole, Jr., MD, Washington University, St. Louis, Mo. on behalf of the LOCATE study group
Session Title & Times: PD60: Prostate Cancer: Detection and Screening VII, 7:00 – 9:00 a.m. CT
Presentation Time: 8:50 – 9:00 a.m. CT
Location: MCP: W185d

INVESTIGATIONAL 18F-FLUCICLOVINE PRESENTATION
Date: Saturday, May 4, 2019
Presentation: Evaluation of fluciclovine (FACBC) PET scan for staging high-risk prostate cancer before primary treatment*
Abstract Number: PD23-08
Presenter: Mehrdad Alemozaffar, MD, Emory University, Atlanta, Ga.
Session Title & Times: PD23: Imaging/Radiology: Uroradiology I, 7:00 – 9:00 a.m. CT
Presentation Time: 8:10 – 8:20 a.m. CT
Location: MCP: W184d

PRESENTATIONS BY THE TECHNICAL UNIVERSITY OF MUNICH ON INITIAL CLINICAL EXPERIENCE WITH 18F-RHPSMA
Date: Friday, May 3, 2019
Presentation: 18F-rhPSMA-7 positron emission tomography for the detection of biochemical recurrence of prostate cancer following radical prostatectomy*
Abstract Number: MP09-16
Presenter: Tobias Maurer, MD, University of Hamburg-Eppendorf (previously Technical University of Munich), Germany
Session Title & Times: MP09: Prostate Cancer: Staging I – 9:30 – 11:30 a.m. CT
Location: MCP: 180

Date: Friday, May 3, 2019
Presentation: Diagnostic efficacy of 18F-rhPSMA-7 positron emission tomography for N-staging of patients with high risk primary prostate cancer*
Abstract Number: PD17-04
Presenter: Tobias Maurer, MD, University of Hamburg-Eppendorf (previously Technical University of Munich), Germany
Session Title & Times: PD17: Prostate Cancer: Staging II, 3:30 – 5:30 p.m. CT
Presentation Time: 4:00 – 4:10 p.m. CT
Location: MCP: 185d

Blue Earth Diagnostics invites participants at AUA2019 to attend the above presentations and to learn more about the company at Booth 3040.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations noted by "*" discuss results of investigational studies or experiences with an investigational agent for which the safety and efficacy have not been established by the FDA.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

ABOUT AXUMIN (FLUCICLOVINE F 18)
Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.