GlycoMimetics to Report First Quarter 2018 Financial Results on May 3, 2018

On April 26, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that it will host a conference call and webcast to report its first quarter 2018 financial results on Thursday, May 3, 2018, at 8:30 a.m. ET (Press release, GlycoMimetics, APR 26, 2018, View Source [SID1234525741]).

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The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 1096657. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the cal

Baxter Reports First-Quarter 2018 Results and Increases Financial Outlook for Full-Year 2018

On April 26, 2018 Baxter International Inc. (NYSE: BAX) reported results for the first quarter of 2018 and increased its full-year 2018 guidance (Press release, Baxter International, APR 26, 2018, View Source [SID1234525763]).

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"Baxter is off to a strong start in 2018," said José (Joe) E. Almeida, chairman and chief executive officer. "Solid top-line performance coupled with a relentless focus on increasing operational efficiency were key drivers of earnings growth in the quarter. We look forward to building on this momentum and sharing the next chapter in Baxter’s ongoing transformation at our upcoming investor conference on May 21st. At the conference, we will highlight the strategic roadmaps for our six global businesses and provide investors an opportunity to learn more about Baxter’s promising innovation pipeline that will help fuel the company’s growth going forward."

First-Quarter Financial Results

In the first quarter, worldwide sales totaled approximately $2.7 billion, an increase of 8 percent on a reported basis, 4 percent on a constant currency basis and 3 percent on an operational basis compared to the prior-year period. Operational sales in the first quarter adjust for the impact of foreign exchange, generic competition for U.S. cyclophosphamide, and the Claris Injectables (Claris) acquisition.

Sales in the U.S. totaled $1.1 billion, increasing 4 percent on a reported basis and 2 percent on an operational basis. International sales of $1.5 billion increased 12 percent on a reported basis, 4 percent on a constant currency basis and 3 percent on an operational basis. Drivers of growth included strong demand for the company’s continuous renal replacement therapies due to an intense flu season, and increased sales of injectable pharmaceuticals and advanced surgery products as well as U.S. IV solutions and peritoneal dialysis therapies.

In line with the financial outlook shared on February 1, 2018, first quarter sales were negatively impacted by approximately $25 million due to the temporary manufacturing disruptions in Puerto Rico caused by Hurricane Maria. All manufacturing facilities in Puerto Rico are operating at pre-hurricane production levels, and the company does not expect any further revenue impact related to recovery efforts. In addition, the company continues to import select products from Baxter facilities under temporary special importation FDA grants, and is grateful to FDA for its continued support in the recovery efforts.

In March, Baxter completed the acquisition of two surgical products from Mallinckrodt plc: RECOTHROM Thrombin topical (Recombinant), the first and only stand-alone recombinant thrombin, and PREVELEAK Surgical Sealant, which is used in vascular reconstruction. Both products complement and broaden Baxter’s surgical portfolio of hemostats and sealants. Sales of these products in the quarter were immaterial and going forward will be reported in the company’s Advanced Surgery business.

As previously disclosed, Baxter now reports its operating results based on three reportable geographic segments: Americas (North and South America), EMEA (Europe, Middle East and Africa) and APAC (Asia Pacific). Net sales are reported based on these reportable segments, as well as by the company’s new Global Business Units (GBUs). Please see the schedules accompanying this press release for more details on sales performance in the quarter.

Baxter reported income from continuing operations of $389 million, or $0.71 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the first quarter. These results included special items totaling $16 million ($(1) million net after-tax), primarily related to business optimization, intangible amortization and a settlement agreement related to the Claris acquisition. On an adjusted basis, Baxter’s first quarter income from continuing operations totaled $388 million, or $0.70 per diluted share. Adjusted earnings per share growth of 21 percent in the quarter was driven by solid top-line performance and the ongoing benefit from the company’s business transformation initiatives as well as a favorable tax rate.

During the quarter, Baxter’s Board of Directors approved a $1.5 billion increase in authorization for the company’s existing share repurchase plan. After accounting for repurchases during the first quarter of $522 million or approximately 8 million shares, the company had approximately $2.1 billion remaining under the authorization as of March 31, 2018. Baxter anticipates that it will continue to repurchase shares in the open market or through private transactions at times and amounts determined by the company based on its evaluation of market conditions and other factors.

In the first quarter of 2018, Baxter generated $447 million in operating cash flow, an increase of $241 million driven by improved operational performance, the ongoing impact of programs focused on enhancing the company’s working capital and a benefit from the settlement of certain claims related to the acquisition of Claris. As a result, the company generated an increase of approximately $210 million in free cash flow to $292 million (operating cash flow less capital expenditures of $155 million) as compared to the prior-year period.

2018 Financial Outlook

For full-year 2018: Based on the company’s strong first quarter, Baxter is raising its financial outlook for the year. The company now expects sales growth of approximately 7 to 8 percent on a reported basis, approximately 5 percent on a constant currency basis and 4 to 5 percent on an operational basis*. Baxter expects adjusted earnings from continuing operations, before special items, of $2.85 to $2.93 per diluted share for the full year.
For the second quarter: The company expects sales growth of approximately 9 percent on a reported basis, approximately 5 percent on a constant currency basis and 3 to 4 percent on an operational basis*. The company expects adjusted earnings from continuing operations, before special items, of $0.69 to $0.71 per diluted share.
*Full-year and second quarter operational sales have been adjusted for the impact of foreign exchange, generic competition for U.S. cyclophosphamide and the benefit from the acquisitions of Claris and the two Mallinckrodt assets.

Please see the schedules accompanying this press release for a reconciliation between the projected 2018 adjusted earnings per diluted share and projected GAAP earnings per diluted share.

A webcast of Baxter’s first quarter 2018 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 26, 2018. Baxter will be hosting an investor conference on Monday, May 21, 2018, in New York City. The investor conference will feature an innovation hall displaying product and therapy advancements from Baxter’s pipeline beginning at 7:00 a.m. EDT and presentations by members of the Baxter management team will begin at 8:00 a.m. EDT. To register for the conference and for more information, click here. Please see www.baxter.com for more information regarding this and future investor events and webcasts.

ONO Submits an Application for Manufacturing and Marketing Approval for Metyrosine (ONO-5371), a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma in Japan

On April 26, 2018 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") reported that it submitted an application for manufacturing and marketing approval of metyrosine (ONO-5371), a tyrosine hydroxylase inhibitor, for the improvement of status of catecholamine excess secretion and its accompanying symptoms in patients with pheochromocytoma in Japan (Press release, Ono, APR 26, 2018, View Source [SID1234584588]).

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This application is based on a multi-center, open-label, non-comparative study and its
accompanying continuous administration study, Phase I/II study (ONO-5371-02), in patients with the symptoms associated with catecholamine excess secretion of pheochromocytoma, conducted in Japan.

Pheochromocytoma (PC) is a neuroendocrine tumor deriving from the adrenal medulla or the extraadrenal gland ganglion with 2,920 patients estimated in Japan. Catecholamine excessively produced from PC causes various symptoms, such as tachycardia, headache, palpitation, sweating, constipation,including hypertension. Sympatholytic drugs, α-blocker and β-blocker, for control of blood pressure and heart rate have been usually used to improve these symptoms. As there aremany cases where surgical removal of tumors is not applicable in patients with locally invasive or metastatic malignant PC, a long-term therapy, such as radiotherapy and chemotherapy is required. The chronic continuation of catecholamine excess secretion may increase a risk of causing cardiovascular-related adverse events such as heart failure or fatal arrhythmia.

Metyrosine is a product for which development companies were recruited in Japan at the "Review Committee on Unapproved or Off-label Drugs with High Medical Needs", established by the Ministry of Health, Labour and Welfare (MHLW). Further, in May 2015, the product was designated for the orphan drug by the MHLW for the indication of "Improvement of status of catecholamine excess secretion and its accompanying symptoms in patients with PC".

ONO obtained exclusive rights to develop and commercialize metyrosine in Japan for the
prevention, treatment and diagnosis of PC (and conditions and symptoms related thereto), in accordance with the license agreement concluded in October 2013 with Valeant Pharmaceuticals North America LLC (Valeant), an affiliate of Valeant Pharmaceuticals International, Inc. In the US, Valeant markets metyrosine under the tradename of "Demser" in the indication of PC.

Methyrosine
Metyrosine inhibits tyrosine hydroxylase related to the production of catecholamine, reduces catecholamine extremely produced from PC, and alleviates symptoms due to catecholamine excess secretion. Therefore, metyrosine is a promising drug with an efficacy in the improvement of the symptoms in patients who are not able to sufficiently control the symptoms with sympatholytic drugs.

Incyte to Present at Upcoming Investor Conference

On April 26, 2018 Incyte Corporation (Nasdaq:INCY) reported that it will present at the Bank of America Merrill Lynch 2018 Health Care Conference on Wednesday, May 16, 2018 at 8:40 am PDT in Las Vegas (Press release, Incyte, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344880 [SID1234525721]).

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The presentation and Q&A session will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

Histogenics Corporation to Report First Quarter 2018 Financial Results on May 10, 2018

On April 26, 2018 Histogenics Corporation (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, reported it will report its first quarter 2018 financial results on May 10, 2018, before the U.S. financial markets open (Press release, Histogenics, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344950 [SID1234525742]).

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The Company will host a conference call on Thursday, May 10, 2018 at 8:30 a.m. EDT. To access the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID "8376199" five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the "Investor Relations" page of the Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the call.