Genmab Announces Financial Results for the First Nine Months of 2017

On November 8, 2017 Genmab reported Financial Results for the First Nine Months of 2017 (Press release, Genmab, NOV 8, 2017, View Source [SID1234521793]).

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Interim Report for the First Nine Months Ended September 30, 2017

Highlights

USD 871 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 707 million

DARZALEX approved for relapsed or refractory multiple myeloma in Japan

Announced positive topline results in Phase III ALCYONE study of daratumumab in front line multiple myeloma

Seattle Genetics exercised its option to co-develop tisotumab vedotin with Genmab

"This past quarter we continued to focus on progressing our innovative antibody pipeline. DARZALEX received its first approval in Japan, for the treatment of relapsed or refractory multiple myeloma. We also reported exciting data from the Phase III ALCYONE study of daratumumab in front line multiple myeloma. Finally, we were pleased to announce that Seattle Genetics exercised its option to co-develop tisotumab vedotin and we very much look forward to our collaboration to rapidly bring this product into the next stages of clinical evaluation," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2017
Revenue was DKK 1,348 million in the first nine months of 2017 compared to DKK 889 million in the first nine months of 2016. The increase of DKK 459 million, or 52%, was mainly driven by higher DARZALEX royalties and milestones.
Operating expenses were DKK 707 million in the first nine months of 2017 compared to DKK 544 million in the first nine months of 2016. The increase of DKK 163 million, or 30%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and other products in our pipeline.
Operating income was DKK 641 million in the first nine months of 2017 compared to DKK 345 million in the first nine months of 2016. The increase of DKK 296 million, or 86%, was driven by higher revenue, which was partly offset by increased operating expenses in 2017.

On September 30, 2017, Genmab had a cash position of DKK 5,184 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 1,262 million, which was mainly driven by positive working capital adjustments of DKK 575 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, our operating income of DKK 641 million, and proceeds from the exercise of warrants of DKK 208 million.

Outlook
Genmab is maintaining its 2017 financial guidance published on February 22, 2017 and reiterated on September 27, 2017.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2017 today, Wednesday, November 8, at 6.00 pm CET, 5.00 pm GMT or 12.00 pm EDT. The dial in numbers are:
+1 646 254 3360 (US participants) and ask for the Genmab conference call
+44 20 3427 1910 (international participants) and ask for the Genmab conference call

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Alkermes’ Corporate Presentation to be Webcast at the Jefferies 2017 London Healthcare Conference

On November 8, 2017 Alkermes plc (NASDAQ: ALKS) reported that its corporate presentation will be webcast live at the Jefferies 2017 London Healthcare Conference on Wednesday, Nov. 15, 2017 at 2:40 p.m. GMT (9:40 a.m. ET) (Press release, Alkermes, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315498 [SID1234521786]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

10-Q – Quarterly report [Sections 13 or 15(d)]

Athersys has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Athersys, 2017, NOV 8, 2017, View Source [SID1234521784]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Supernus has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Supernus, 2017, NOV 8, 2017, View Source [SID1234521829]).

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KY1044 strongly inhibits tumour growth in models

On November 8, 2017 Kymab reported that its team will present data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 32nd Annual Meeting on its novel anti-ICOS antibody KY1044, the lead candidate in its immuno-oncology pipeline, which shows strong potential for inhibiting tumour growth (Press release, Kymab, NOV 8, 2017, View Source [SID1234537008]). The poster is available online.

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Kymab’s data, which is based on non-human tumour models, suggests that KY1044 strongly inhibits tumour growth, including complete remissions, in a number of cancer models, both as a monotherapy and acting synergistically in combination with checkpoint inhibitors such as anti-PD-L1.

"We are excited to unveil KY1044, the lead development product in our growing immuno-oncology franchise, where we are focusing on enabling the patient’s own immune system to boost its intrinsic ability to eradicate tumours," says Dr David Chiswell, CEO of Kymab.

"We believe that KY1044 has considerable potential and will provide patient benefits in a significant number of cancer indications."

KY1044 is a fully human antibody that allows the immune system to better recognise and kill tumours.

KY1044 has a dual mode of action: stimulating immune cells which are fighting the tumour, while also killing a type of cell known as T regulatory cells (Tregs). Tregs are often found in tumours and inhibit the immune response and prevent or slow the activity of anti-tumour T-cells.

Intratumoural Tregs express a high level of ICOS on their surface. Removing these cells using KY1044 allows the immune system to work more effectively at killing cancer cells.

Kymab plans to file an investigational new drug application for KY1044 in late 2018 and commence clinical trials in 2019. KY1044 will be evaluated in cancer patients both as a monotherapy and in combination with other immunotherapies.

The SITC (Free SITC Whitepaper) meeting is being held on 8-12 November 2017 at the Gaylord National Hotel & Convention Center, in Maryland, USA. The Kymab poster will be presented on Saturday, 11 November, 2017 at 12.30 to 14.00 and 18.00 to 20.00. Please see below for more information.

Notes to Editors
Issued Cambridge, UK, 8 November 2017
Read the PDF version of the issued Press Release

About Kymab’s SITC (Free SITC Whitepaper) Poster
Title: KY1044, a novel anti-ICOS antibody, elicits long term in vivo anti-tumour efficacy as monotherapy or in combination with immune checkpoint inhibitors.
Poster Number: 288
Date: Saturday, November 11, 2017
Session Time: 12.30 to 14.00 and 18.00 to 20.00
Location: Prince George’s Exhibition Hall DE, Gaylord National Hotel & Convention Center, in Maryland, USA
The Kymab poster is available at: View Source