10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

PRA Health Sciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, PRA Health Sciences, 2018, FEB 22, 2018, View Source [SID1234524982]).

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OncoMed Pharmaceuticals to Report Fourth Quarter and Full Year 2017 Financial Results and Operational Highlights on March 8th, 2018

On February 22, 2018 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that the Company will report fourth quarter and full year 2017 financial results and operational highlights on Thursday, March 8th, 2018 (Press release, OncoMed, FEB 22, 2018, View Source [SID1234524142]). OncoMed management will host a conference call and webcast at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT).

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Analysts and investors can participate in the conference call by dialing (855) 420-0692 (domestic) and (484) 756-4194 (international) using the conference ID# 4997704. The webcast of the conference call can be accessed live on the Investor Relations section of the OncoMed website, View Source, and will be available for replay through June 30th, 2018.

An audio replay of the conference call can be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) utilizing the conference ID number listed above.

Xencor Doses First Patient in Phase 1 Study of XmAb®18087 Bispecific Tumor Targeting Antibody for the Treatment of Neuroendocrine Tumors and Gastrointestinal Stromal Tumors

On February 22, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that the first patient has been dosed in a Phase 1 clinical trial of XmAb18087, a bispecific antibody for the treatment of neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST) (Press release, Xencor, FEB 22, 2018, View Source [SID1234524359]).

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"XmAb18087 engages the immune system against tumors by binding to somatostatin receptor 2 (SSTR2) and CD3," said Paul Foster, M.D., chief medical officer at Xencor. "In preclinical studies, XmAb18087 has shown potent killing of human tumor cell lines in vitro and in vivo and the stimulation of target-dependent T-cell activation. This is our first bispecific antibody targeting solid tumors to enter into clinical trials, and we expect to file INDs for three more bispecific antibodies for solid tumors this year."

The trial is a multiple ascending dose study to determine the safety and tolerability, pharmacokinetics and immunogenicity, and preliminary anti-tumor activity of weekly intravenous administration of XmAb18087 and to determine the maximally tolerated dose and regimen in patients with advanced NET or GIST.

For more information about the XmAb18087 clinical trial please visit to View Source (identifier: NCT03411915).

About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are abnormal growths that begin in neuroendocrine cells, which are distributed widely throughout the body. Most neuroendocrine tumors occur in the lungs, appendix, small intestine, rectum and pancreas. It is estimated that more than 12,000 people in the United States are diagnosed with a neuroendocrine tumor each year. For more information visit www.cancer.net.

About Gastrointestinal Stromal Tumors
Gastrointestinal stromal tumors (GISTs) are soft-tissue sarcomas, cancers that grow from cells of the body’s connective or supportive tissues, that can be located in any part of the digestive system. The most common sites of GISTs are the stomach and small intestine. Each year, as many as 3,500 to 4,000 adults in the United States will be diagnosed with a GIST. For more information visit www.cancer.net.

About Xencor’s XmAb Bispecific Technology
As opposed to traditional monoclonal antibodies that target and bind to a single antigen, bispecific antibodies are designed to elicit multiple biological effects that require simultaneous binding to two different antigen targets. Xencor’s XmAb bispecific Fc domain technology is designed to maintain full-length antibody properties in a bispecific antibody, potentially enabling favorable in vivo half-life and simplified manufacturing.

Pacira Pharmaceuticals Announces Timing for 2017 Financial Results Webcast and Conference Call

On February 22, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that it will report its fourth quarter and year ended December 31, 2017 financial results before the open of the U.S. markets on Wednesday February 28, 2018 (Press release, Pacira Pharmaceuticals, FEB 22, 2018, View Source;p=RssLanding&cat=news&id=2334116 [SID1234524143]). The announcement will be followed by a conference call at 8:30 a.m. ET. Participating in the call from Pacira will be Dave Stack, chairman and chief executive officer, and other members of the company’s senior management team.

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The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 5198726. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 5198726. The replay of the call will be available for one week from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Genmab 2017 Annual Report

On February 21, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported its Annual Report for 2017 (Press release, Genmab, FEB 21, 2018, View Source [SID1234524098]). Below is a summary of business progress and financial performance for the year, and financial outlook for 2018 from the report. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source

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2017 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress

EMA decision & launch in 2nd line + multiple myeloma (MM) relapsed / refractory setting – Achieved
FDA decision 3rd line MM setting (daratumumab + pomalidomide) – Achieved
Phase III MM interim efficacy analysis in frontline (ALCYONE trial) – Achieved
Start Phase III subcutaneous trial – Achieved
Start trials in solid tumors and non-MM blood cancers – Achieved
Report non-MM clinical data — Expected in 2018
Optimize ofatumumab value

Phase III refractory FL headline results — Expected in 2018
Strengthen differentiated product pipeline

Phase I/II tisotumab vedotin data – Achieved
Progress HuMax-AXL-ADC Phase I/II clinical trial – Achieved
IND/CTA submission HexaBody-DR5/DR5 – Achieved
IND/CTA submission DuoBody-CD3xCD20 – Achieved
Progress pre-clinical pipeline — Achieved
Strengthen partnership portfolio with next generation technologies

Enter new technology collaborations — Not achieved
Progress partnered programs — Achieved
Disciplined financial management

Execute controlled company growth with selective investments in product pipeline — Achieved
Financial Performance

Revenue was DKK 2,365 million in 2017 compared to DKK 1,816 million in 2016. The increase of DKK 549 million, or 30%, was mainly driven by higher DARZALEX royalties under our daratumumab collaboration with Janssen.
Operating expenses increased by DKK 258 million, or 34%, from DKK 763 million in 2016 to DKK 1,021 million in 2017 driven by the advancement of tisotumab vedotin, the addi­tional investment in our product pipeline, and the increase in employees to support the expansion of our pipeline.
Operating income was DKK 1,344 million in 2017 compared to DKK 1,053 million in 2016. The improvement of DKK 291 million, or 28%, was driven by higher revenue, which was partly offset by increased operating expenses.
2017 year end cash position of DKK 5,423 million, an increase of DKK 1,501 million, or 38%, from DKK 3,922 million as of December 31, 2016.
2018 OUTLOOK

MDKK 2018 Guidance 2017 Actual Result
Revenue 2,700 — 3,100 2,365
Operating expenses (1,400) — (1,600) (1,021)
Operating income 1,300 — 1,500 1,344

Revenue
We expect our 2018 revenue to be in the range of DKK 2,700 — 3,100 million, compared to DKK 2,365 million in 2017. Our projected revenue for 2018 consists primarily of DARZALEX royalties of approximately DKK 1,750 million that are based on an estimated USD 2.0 — 2.3 billion of DARZALEX net sales in 2018. We project DARZALEX milestones of approximately DKK 550 million in 2018, consisting primarily of a commercial net sales-based milestone, compared to DKK 1,109 million in 2017. In addition, the 2018 guidance includes the one-time payment from Novartis of approximately DKK 300 million related to the transition of Arzerra from commercial availability to compassionate use programs in non-US markets. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.

The overall increase in revenue compared to 2017 is primarily due to a one-time payment from Novartis combined with higher DARZALEX royalties which were partly offset by a decrease in DARZALEX milestones.

Operating Result
We anticipate that our 2018 operating expenses will be in the range of DKK 1,400 — 1,600 million, compared to 2017 operating expenses of DKK 1,021 million. The increase is driven by the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and an increase in employees to support the expansion of our product pipeline.

We expect the operating income for 2018 to be approximately DKK 1,300 — 1,500 million compared to DKK 1,344 million reported for 2017.

More information on the Risks and Assumptions for the 2018 Financial Guidance can be found in the 2017 Annual Report available on our website www.genmab.com.

Conference Call
Genmab will hold a conference call in English to discuss the results for the full year 2017 today, February 21, 2018 at 6.00 pm CET, 5.00 pm GMT or noon EST. To join the call by phone, dial one of the following numbers and ask for the Genmab conference call:

US: + 1 646 828 8156
UK: + 44 330 336 9411
DK: + 45 35 15 81 21

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