Insmed to Host First Quarter 2018 Financial Results Conference Call on Wednesday, May 2, 2018

On April 25, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that it will release its first quarter 2018 financial results on Wednesday, May 2, 2018 (Press release, Insmed, APR 25, 2018, View Source [SID1234525672]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Wednesday, May 2, 2018 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (844) 707-0669 (domestic) or (703) 639-1223 (international) and referencing conference ID number 4567628. The call will also be webcast live on the internet on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through May 9, 2018 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and referencing conference ID number 4567628. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

Incyte Highlights Abstracts Accepted for Presentation at the 2018 ASCO Annual Meeting

On April 25, 2018 Incyte Corporation (Nasdaq:INCY) reported that multiple abstracts from its research and development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois from June 1-5, 2018 (Press release, Incyte, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344710 [SID1234525693]).

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Data at ASCO (Free ASCO Whitepaper) 2018 include oral presentations from a Phase 1 study of ruxolitinib (Jakafi), lenalidomide and methylprednisolone in patients with relapsed and refractory multiple myeloma, the DeCidE1 trial assessing the combination of DPX-Survivac, cyclophosphamide and epacadostat in patients with recurrent epithelial ovarian cancer, and the Phase 3 ECHO-301/KEYNOTE-252 study evaluating the safety and efficacy of epacadostat in combination with pembrolizumab in patients with unresectable or metastatic melanoma.

"Data featured in the abstracts presented at ASCO (Free ASCO Whitepaper) will contribute to the broader scientific understanding of our targeted and immuno-oncology therapies and their potential role in the treatment of cancer," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to sharing data from our portfolio at the 2018 ASCO (Free ASCO Whitepaper) annual meeting as we continue to work toward our goal of improving the lives of patients with cancer and other serious diseases."

Select key abstracts and presentations include:

Targeted therapy abstracts

A Phase 1 Trial of Ruxolitinib, Lenalidomide, and Methylprednisolone for Relapsed/Refractory Multiple Myeloma Patients. (Abstract #8005, oral abstract session)

Friday, June 1, 2018, 2:45 – 5:45 p.m. CT, E450

Immuno-oncology abstracts

Clinical Data from the DeCidE1 trial: Assessing the First Combination of DPX-Survivac, Low Dose Cyclophosphamide (CPA), and Epacadostat (INCB024360) in Subjects with Stage IIc-IV Recurrent Epithelial Ovarian Cancer. (Abstract #5510, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, S406

Epacadostat (E) Plus Pembrolizumab (P) Versus Pembrolizumab Alone in Patients (pts) with Unresectable or Metastatic Melanoma: Results of the Phase 3 ECHO-301/KEYNOTE-252 Study. (Abstract #108, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, Hall D1

Pilot Trial of an Indoleamine 2,3-dioxygenase-1 (IDO1) Inhibitor Plus a Multipeptide Melanoma Vaccine in Patients with Advanced Melanoma. (Abstract #3033, poster session)

Monday, June 4, 2018, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #247

Epacadostat Plus Nivolumab for Advanced Melanoma: Updated Phase 2 Results of the ECHO-204 Study. (Abstract #9511, poster discussion session)

Monday, June 4, 2018, 1:15 – 4:45 p.m. CT, Hall A, Poster Board #338; Discussion at 4:45 – 6:00 p.m. CT, E451

Full session details and data presentations at the ASCO (Free ASCO Whitepaper) 2018 annual meeting can be found here.

Calithera Biosciences Announces CB-839 Abstracts Accepted for Presentation at ASCO 2018

On April 25, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that three abstracts describing CB-839, the Company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 1 to June 7, 2018 in Chicago, Illinois (Press release, Calithera Biosciences, APR 25, 2018, View Source [SID1234535240]).

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Calithera’s collaborators will present the following results:

Phase I clinical trial of the glutaminase inhibitor CB-839 plus capecitabine in patients with advanced solid tumors Abstract #2562 Presenter: Jennifer R. Eads, M.D., Case Comprehensive Cancer Center
Date: June 4, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall
A Developmental Therapeutics–Clinical Pharmacology and Experimental Therapeutics Funding for this study was provided in part by Stand Up To Cancer1. Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.

CANTATA: A randomized phase 2 study of CB-839 in combination with cabozantinib vs. placebo with cabozantinib in patients with advanced metastatic renal cell carcinoma.
Abstract #TPS4601 Presenter: Nizar M. Tannir, M.D., MD Anderson Cancer Center
Date: June 2, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Genitourinary (Non-Prostate) Cancer

Novel PET/CT imaging biomarkers of CB-839 in combination with panitumumab and irinotecan in patients with metastatic and refractory RAS wildtype colorectal cancer: A phase I/II study Abstract #TPS3616 Presenter: Satya Das, M.D., Vanderbilt University Cancer Center Date: June 3, 2018 Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Gastrointestinal (Colorectal) Cancer About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

MorphoSys to Host Q1 2018 Conference Call on May 3, 2018

On April 25, 2018 MorphoSys AG (FSE: MOR) (XETRA: MOR) (OTC PINK: MPSYY) reported that it will publish its first three months’ 2018 results on May 2nd, 2018 at 10:00 p.m. CEST (4 p.m. EDT; 9 p.m. BST) (Press release, MorphoSys, APR 25, 2018, View Source [SID1234525673]).

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The Management team of MorphoSys AG will host a conference call and webcast on May 3rd, 2018 at 2:00 p.m. CEST to present MorphoSys’s first quarter interim statement 2018 and provide an outlook for 2018.

Date of the conference call: Thursday, May 3, 2018

Time: 2:00 p.m. CEST (1:00 p.m. BST, 9:00 a.m. EDT)

Dial-in numbers (listen only):

Germany: +49 (0) 69 201 744 210
United Kingdom: +44 (0) 203 009 2470
USA: +1 (0) 877 423 0830

Participant PIN: 61629746#

Company participants in the call will be:

Dr. Simon Moroney, Chief Executive Officer

Jens Holstein, Chief Financial Officer

Participants are kindly requested to dial in up to 10 minutes before the call to ensure a secure line and a prompt start. If you need assistance during the conference call, please press * and 0 on the phone to get connected with an operator.

The presentation slides and webcast link will be available at the Company’s website at View Source

A slide-synchronized audio replay of the conference will also be available at the corporate website following the live event.

Integra LifeSciences Reports First Quarter 2018 Financial Results

On April 25, 2018 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the first quarter ending March 31, 2018 (Press release, Integra LifeSciences, APR 25, 2018, View Source [SID1234525694]).

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First Quarter 2018 Consolidated Results

Reported revenue was $357.1 million, an increase of 38.1% compared to the first quarter of 2017; acquisitions contributed $91.6 million of revenue to the first quarter, and organic revenues increased 3.0%;

GAAP earnings per share was $0.14, reflecting an increase of 75.0% compared to the first quarter of 2017;

Adjusted earnings per share was $0.58, reflecting an increase of 48.7% compared to the first quarter of 2017;

Cash flow from operations was $41.5 million, reflecting an increase of 43.8% from the first quarter of 2017;

The company is raising its full-year 2018 guidance based on strong first quarter results to

Revenue of $1.47 billion to $1.49 billion (previously $1.46 billion to $1.48 billion);

GAAP EPS of $0.69 to $0.77 (previously $0.60 to $0.70); and

Adjusted EPS of $2.34 to $2.42 (previously $2.25 to $2.35).

The company is reiterating its full-year 2018 guidance for organic sales growth to be approximately 5.0%.

Total revenues for the first quarter 2018 were $357.1 million, reflecting an increase of 38.1%, over the first quarter of 2017. Sales in the Codman Specialty Surgical segment increased 51.1% compared to the first quarter of 2017, driven by the acquired revenues from Codman Neurosurgery, as well as strong capital sales of CUSA Clarity. Sales in the Orthopedics and Tissue Technologies segment increased 18.2%, reflecting a full quarter of sales from Derma Sciences and strength in both our regenerative technologies, as well as our ankle and shoulder portfolios.
Total organic revenues increased 3.0% over the first quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates, slightly ahead of our expectations.
"We are off to a strong start in 2018, which gives us the confidence to increase our full-year 2018 financial guidance," said Peter Arduini, Integra’s president and chief executive officer. "We are pleased with the progress of the Codman integration and continued progress in the OTT channel expansion. We expect to see organic growth accelerate in the remainder of the year."
The company reported GAAP net income of $11.0 million, or $0.14 per diluted share, for the first quarter of 2018, compared to GAAP net income of $6.4 million, or $0.08 per diluted share, in first quarter of 2017. The increase in GAAP net income results from higher revenues, better operating expense leverage, and a lower tax rate.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.
Adjusted EBITDA for the first quarter of 2018 was $83.2 million, or 23.3% of revenue, compared to $55.2 million, or 21.3% of revenue, in the first quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from general and administrative costs.
Adjusted net income for the first quarter of 2018 was $46.1 million, an increase of 49.4% from the prior year’s quarter. Adjusted earnings per share for the first quarter of 2018 were $0.58, an increase of 48.7% over the prior year’s quarter.
2018 Full-Year Outlook
The company is raising its full-year 2018 revenue guidance by $10 million to a new range of $1.47 billion to $1.49 billion, based on the strong performance of the Codman Specialty Surgical segment in the first quarter of 2018, as well as a higher benefit expected from foreign currency translation. The company is raising its full-year 2018 GAAP and adjusted earnings per share guidance range by $0.08 to a new range of $0.69 to $0.77 and $2.34 to $2.42, respectively.
The company is reiterating its full-year 2018 guidance for organic sales to be approximately 5.0%.
"In addition to the strong revenue performance in the quarter, we were pleased with the significant improvement in EBITDA margin and strong operating cash flow," said Glenn Coleman, Integra’s chief financial officer. "This puts us on track to achieve the high-end of our full-year guidance for these metrics for the remainder of this year."

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 25, 2018, 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 (323) 794-2093 and using the passcode 5958152. 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 30, 2018 by dialing (719) 457-0820 and using the passcode 5958152. The webcast will also be archived on the website.