On March 2, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported financial results for the year ending December 31, 2015, as well as a financial and operational outlook on 2016.

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Financial Year 2015 results and key operational achievements 2015:

FY2015 revenues of EUR 106.2 million (2014: EUR 64.0 million) and EBIT of EUR 17.2 million (2014: EUR -5.9 million) exceed latest financial guidance.

2015 revenues and EBIT have been significantly impacted by a non-recurring effect attributable to the ending of the collaboration with Celgene.

Strong cash position of EUR 298.4 million at end of 2015 (EUR 352.8 million end of 2014).

Product pipeline further expanded in 2015 to 103 programs (89 partnered, 14 proprietary) up from 94 programs (84 partnered, 10 proprietary) at year-end 2014.

Main cancer programs MOR208 and MOR202 with encouraging phase 2 clinical data in hematological indications non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (MOR208) and multiple myeloma (MOR202).

In EUR million* FY 2015 FY 2014 Q4 2015 Q4 2014

Group Revenues 106.2 64.0 12.3 17.0
Total Operating Expenses 93.7 70.1 30.1 19.0
Earnings Before Interest and Taxes (EBIT) 17.2 (5.9) (17.5) (2.2)
Consolidated Net Profit/(Loss) 14.9 (3.0) (13.3) (1.0)
Diluted Net Profit/(Loss) per Share 0.57 (0.12) (0.51) (0.04)
* Differences due to rounding

Operational and financial outlook 2016:

Partnered discovery: Phase 3 readouts and potential filings for approval for antibodies bimagrumab in sporadic inclusion body myositis (sIBM, Novartis) and guselkumab in psoriasis (Janssen) expected.

Proprietary development: Increase in R&D activities planned to advance existing clinical programs and to begin clinical development of MOR106 and MOR107 in 2016.

R&D budget for proprietary drug development expected to increase to EUR 76 to 83 million in 2016 (2015: EUR 56.6 million). The bulk of these expenses will flow into the clinical development of MorphoSys’s most advanced proprietary drug candidates.

Revenues 2016 expected in the amount of EUR 47 to 52 million. EBIT 2016 expected in a range from EUR -58 to -68 million.

Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, stated: "The progress made in 2015 has contributed to MorphoSys now having a product pipeline that is broader and more mature than ever before. The first therapeutic antibodies are nearing market approval, bringing us closer to a product-based revenue stream that we expect will grow significantly in the years ahead. Meanwhile, our proprietary development portfolio is expanding and the two most advanced programs are approaching the decisive stage of clinical development. Across our entire pipeline, we see many programs which have the potential to transform the treatment of the diseases they address, to the benefit of all of our stakeholders, not least, the patients who they will help."

"MorphoSys’s portfolio is one of the broadest in the industry. This is supported by financial resources of close to EUR 300 million at the end of 2015 that allows us to operate from a position of strength. Our solid financial position enables us to increase R&D expenses to grow the Company’s value without losing sight of our prudent and efficient use of resources," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.

Update on MorphoSys’s Proprietary Antibody Portfolio

At the end of 2015, MorphoSys’s proprietary portfolio comprised 14 (2014: 10) innovative development programs, of which 4 (2014: 3) are in clinical development.

MOR208 – An anti-CD19 antibody for the treatment of B cell malignancies.

At the 2015 ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper) meetings, positive data from a phase 2a study with MOR208 in 92 patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) were presented.

At the 2015 ASH (Free ASH Whitepaper) meeting, investigators at The Ohio State University reported on an investigator-initiated trial (IIT) of a combination of MOR208 with lenalidomide in relapsed/refractory or treatment-naive CLL patients. This study has recently been amended to add MOR208 on top of ongoing therapy with ibrutinib in patients suffering a relapse.

In 2016, MorphoSys will start two clinical combination trials for MOR208 in DLBCL and one in CLL. One of the DLBCL trials is intended to transition into a pivotal study in 2017.

MOR202 – A HuCAL antibody against CD38 for treatment of multiple myeloma (MM).

Encouraging clinical data from the ongoing dose-escalation trial of MOR202 alone and/or in combination with lenalidomide or pomalidomide (IMiDs – immunomodulatory drugs) were presented at ASCO (Free ASCO Whitepaper) and ASH (Free ASH Whitepaper) 2015.

The 16 mg/kg MOR202 confirmation cohort is enrolling and the 16 mg/kg IMiDs combination cohorts will be initiated soon.
Patients receiving MOR202 plus pomalidomide have shown very encouraging responses, which have deepened considerably since first data was reported at ASH (Free ASH Whitepaper) in December 2015.

Updated clinical data will be presented at an upcoming medical conference.
MOR209/ES414 – An anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer. The compound is part of a co-development and co-commercialization agreement between MorphoSys and Emergent BioSolutions.

After examination of the initial clinical data, it was decided to adjust the dosing regimen and administration of MOR209/ES414. Clinical development will continue in 2016 using an amended clinical development plan, with recruitment to start around mid-2016.
Under the terms of the updated collaboration agreement, MorphoSys’s cost sharing in the years 2016 to 2018 and future milestone payments payable to Emergent BioSolutions by MorphoSys were reduced.
MOR103 – A HuCAL antibody directed against GM-CSF, out-licensed to GlaxoSmithKline (GSK) in 2013, is being developed by GSK in inflammatory diseases.

In the third quarter of 2015, GSK announced the commencement of a phase 2b study with MOR103 (re-named GSK3196165) in rheumatoid arthritis.
GSK plans to initiate a phase 1b/2a study in osteoarthritis of the hand in 2016.
Progress within MorphoSys’s Partnered Pipeline

During 2015, the number of therapeutic antibodies in MorphoSys’s partner pipeline grew to a total of 89 (December 31, 2014: 84). Of those, 21 antibodies were in clinical development, 25 in preclinical development and 43 in the discovery phase at year-end.
Two new antibodies entered phase 1 clinical development in 2015.
Financial Review for the Fiscal Year 2015 (IFRS)

Group revenues for the full year 2015 increased by 66 % to EUR 106.2 million (2014: EUR 64.0 million). This increase is mainly due to a contribution of approximately EUR 59 million from the recognition of deferred revenues and a one-time payment attributable to the early termination of a collaboration with Celgene. The Proprietary Development segment achieved revenues of EUR 59.9 million (2014: EUR 15.0 million), resulting from the non-recurring effect attributable to the above event. Revenues in the Partnered Discovery segment of EUR 46.3 million included EUR 42.3 million in funded research and licensing fees (2014: EUR 43.6 million) and EUR 4.0 million in success-based payments (2014: EUR 5.4 million).

Total operating expenses for the full year 2015 increased by 34 % to EUR 93.7 million (2014: EUR 70.1 million). Total research and development expenses (R&D) increased by EUR 22.7 million to EUR 78.7 million in 2015 (2014: EUR 56.0 million) mainly due to higher costs for external laboratory services and personnel. R&D expenses for proprietary research and development amounted to EUR 56.6 million (2014: EUR 36.4 million). General and administrative expenses (G&A) amounted to EUR 15.1 million (2014: EUR 14.1 million). Personnel expenses from share-based payments are included in G&A expenses and R&D expenses. These expenses amounted to EUR 3.6 million in 2015 (2014: EUR 4.0 million). Other income and expenses amounted to EUR 4.7 million (2014: income of EUR 0.2 million).

Earnings before interest and taxes (EBIT) amounted to EUR 17.2 million (2014: EUR -5.9 million). The increase is driven by one-off effects in the context of the ending of the MOR202 collaboration with Celgene in the first quarter of 2015. Proprietary Development showed a segment EBIT of EUR 10.7 million (2014: EUR -18.4 million), while the Partnered Discovery segment reported an EBIT of EUR 20.4 million (2014: EUR 25.9 million).

Finance income for 2015 amounted to EUR 3.4 million (2014: EUR 1.6 million). The Group reported income tax expenses of EUR 5.7 million (2014: tax benefit of EUR 1.3 million). Due to the positive one-off effects realized in 2015, MorphoSys generated a consolidated net profit of EUR 14.9 million compared to a net loss of EUR -3.0 million in 2014. The diluted net result per share amounted to EUR 0.57 (2014: EUR -0.12).

On 31 December 2015, the Company had a cash position of EUR 298.4 million, compared to EUR 352.8 million on December 31, 2014. In the balance sheet this cash position is reported under the positions: cash and cash equivalents; available-for-sale financial assets; bonds, available-for-sale; financial assets classified as loans & receivables; and financial assets classified as loans & receivables, net of current portion.

Net cash outflow from operating activities in 2015 totaled EUR 23.5 million (2014: cash outflow EUR 14.2 million). Resulting from the exercise of 80,848 convertible bonds in 2015, the number of shares issued rose to 26,537,682 by December 31, 2015 (December 31, 2014: 26,456,834).

Fourth Quarter of 2015 (IFRS)

In the fourth quarter of 2015, the Company generated revenues in the amount of EUR 12.3 million, compared to EUR 17.0 million in the same quarter of 2014. Total operating expenses amounted to EUR 30.1 million in Q4, compared to EUR 19.0 million in the same quarter of 2014. The increase in operating expenses was mainly due to higher expenses for third party services. The EBIT amounted to EUR -17.5 million (Q4 2014: EUR -2.2 million). Group net loss for the fourth quarter 2015 was EUR -13.3 million, compared to a net loss of EUR -1.0 million in the fourth quarter of 2014.

Outlook for 2016

In line with its intention to advance and broaden its proprietary pipeline, MorphoSys will increase its spending on proprietary drug development in comparison to the previous year. The majority of the expenses will flow into the clinical development of MorphoSys’s most advanced drug candidates.

MOR208: MorphoSys plans to initiate two phase 2 trials, the first of which will combine MOR208 and lenalidomide in DLBCL, the second of which will combine MOR208 and idelalisib in ibrutinib-refractory CLL. In the second half of 2016, the Company will start a further study in DLBCL, combining MOR208 and bendamustine. This trial is intended to lead into a pivotal study in 2017.

MOR202: MorphoSys plans to generate additional clinical data from an ongoing phase 1/2a trial in multiple myeloma (MM) evaluating the confirmation cohort of 16 mg/kg MOR202 alone as well as the cohorts and confirmation cohorts of 16 mg/kg MOR202 in combination with lenalidomide or pomalidomide.

With MOR209, MorphoSys expects to continue the phase 1 trial in metastatic castration-resistant prostate cancer (mCRPC) using an amended dosing scheme.

MorphoSys expects to start clinical development of MOR106 (jointly developed with Galapagos) and of MOR107, the first drug candidate from the Company’s acquisition of Lanthio Pharma.

In the Partnered Discovery segment, MorphoSys expects two phase 3 readouts and potential filings for approval for the antibodies bimagrumab in sIBM (Novartis) and guselkumab in psoriasis (Janssen). This would mark the first approvals of HuCAL antibodies.
MorphoSys expects Group revenues for the 2016 financial year in the range of EUR 47 to 52 million. R&D expenses for proprietary drug development are expected to rise to EUR 76 to 83 million. The Company expects earnings before interest and taxes (EBIT) in a range of between EUR -58 to -68 million. This guidance does not include any potential in-licensing or co-development of further development candidates.

MorphoSys will hold its conference call and webcast today to present the Annual Financial Results 2015 and the Outlook 2016.

On March 2, 2016 OPKO Health, Inc. reported that its GeneDx subsidiary and business unit has been selected to give 11 platform talks and 18 poster presentations on a range of genetics-related topics at the 2016 American College of Medical Genetics and Genomics (ACMG) Annual Meeting (Press release, Opko Health, MAR 2, 2016, View Source [SID:1234509330]). These presentations support GeneDx’s position as an industry leader in the wider genomics industry.

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Marc Grodman MD, CEO of BioReference/GeneDX states, "We are honored to have such a large number of presentations accepted at this year’s ACMG meeting and believe the depth and scope of our contributions demonstrate not only our commitment in expanding the scope of our genomic testing but also a meaningful contribution to enrich the scientific community at large."

This year’s presentations cover a range of topics ranging from inherited cancer testing to whole exome sequencing. Some of GeneDx’s featured presentations at the meeting include:

GeneDx’s experience from the first 100 XomeDxXpress cases performed for patients in critical care including diagnostic yield and how the results impacted medical management;
The potential use of Whole Exome Sequencing for fetal anomalies and fetal demise;
The detection of mosaic variants in genes causing germline neurodevelopmental disorders, such as epilepsy;
Multiple talks describing genes that have recently been associated with neurodevelopmental delay, either as a new gene-disease association or as an expansion of a previously described clinical phenotype.

For a complete list of GeneDx’s platform presentations and posters, please visit the GeneDx website View Source or stop by and visit booth #413 at the 2016 ACMG conference to learn more.

Over the last several years, GeneDx has been striving to better understand the genetic causes of autism and intellectual disability through research and its robust Whole Exome Sequencing program, perhaps best demonstrated by several of the company’s presentations at this year’s ACMG annual meeting. Based on this increased understanding and knowledge, GeneDx is proud to announce the launch of its Autism/Intellectual Disability (ID) Xpanded Panel. This is a dynamic testing panel analyzing approximately 2,000 genes that have been associated with autism, intellectual disability and/or developmental delay.

On March 1, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that it has received a patent from the U.S. Patent and Trademark Office, U.S. Patent No. 9,273,022 (Filing, 8-K, Provectus Pharmaceuticals, MAR 1, 2016, View Source [SID:1234509318]). The patent extends the scope of protection of the manufacturing process conferred initially by U.S. Patent No. 8,530,675, issued in 2013, to include coverage of the use of an alternative raw material in manufacturing the active ingredient (API) in PV-10.

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Provectus believes that this patent, wholly owned by Provectus and conferring coverage to at least 2031, will provide further protection around the proposed commercial process for manufacturing PV-10. Investigational drug product generated using this proprietary technology is being used in all ongoing clinical trials of PV-10, including the pivotal phase 3 trial in melanoma (NCT02288897).

Provectus’ efforts to bring this process development to fruition were supported by Cambrex Charles City, Inc., a subsidiary of Cambrex Corporation (NYSE:CBM, www.cambrex.com), a life sciences company that provides products and services that accelerate and improve the development and commercialization of new and generic therapeutics.

Dr. Eric Wachter, CTO of Provectus, noted, "It is a pleasure to have Cambrex team members as co-inventors on this process patent. Although the scientists and engineers working behind the scenes aren’t always visible to patients or shareholders, these professionals work tirelessly to enable manufacturing the active ingredient in PV-10 on a commercial scale. Chemistry, Manufacturing and Controls (CMC) is a critical part of any investigational new drug (IND) application and subsequent new drug application (NDA), and this aspect of our PV-10 submission is built on a firm foundation, due in no small part to the efforts of the Cambrex team."

Dr. Kurt Kiewel, Director of R&D at Cambrex Charles City, said, "We feel fortunate to bring the depth of our experience in custom development and API manufacturing to support promising investigational products like PV-10. It has been our pleasure to work with the innovative scientists at Provectus to help advance this potential new cancer treatment toward the market."

On March 1, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of February it has enrolled 27 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, MAR 1, 2016, View Source [SID:1234509319]). Total patient enrollment for the trial is now 724 as of February 29, 2016 in the world’s largest Phase 3 study in head and neck cancer.

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"Through clinical centers in 24 countries, we continue to enroll patients at an average rate of about one per day. With enrollment numbers now over 700, we are nearing our full enrollment goal," stated CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that is given BEFORE surgery, radiation and chemotherapy because that is when the immune system is thought to be the strongest, one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On March 1, 2016 Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo Pharma or the Company), formerly known as Nuvo Research Inc. and Crescita Therapeutics Inc. (TSX:CTX) (Crescita), reported the completion of the reorganization of Nuvo Research Inc. into two separate publicly traded companies (the Reorganization) (Press release, Nuvo Research, MAR 1, 2016, View Source [SID:1234512698]). As a result of the Reorganization, the shareholders of what was formerly Nuvo Research Inc., now own 100% of Nuvo Pharma, a revenue and EBITDA generating commercial healthcare company, and 100% of Crescita, a drug development company. The Reorganization was approved by the shareholders of Nuvo Research Inc. at a special shareholders meeting on February 18, 2016 and by the Ontario Superior Court of Justice on February 24, 2016.

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"This transaction gives both businesses greater flexibility to focus on, and pursue, their respective growth strategies," said John London, President and CEO of Nuvo Pharma. "Nuvo Pharma is a profitable business with significant revenue and EBITDA growth potential." "We are very excited about the launch of Crescita," added Dan Chicoine, Chairman and CEO of Crescita. "We have exciting technologies, a proven management team that has obtained FDA approval for four topical pharmaceutical products and a strong balance sheet to support our growth."

Under the Reorganization, existing Nuvo Research Inc. share certificates now represent common shares of Nuvo Pharma and the right to receive a share certificate representing an equal number of Crescita common shares. The distribution record date (the Record Date) for certificates representing Crescita common shares is Thursday March 3, 2016. However, the TSX has implemented due bill trading for the Nuvo Pharma common shares (TSX: NRI) until the close of trading on Friday March 4, 2016. Accordingly, shareholders who purchase Nuvo Pharma common shares through the facilities of the TSX prior to the close of trading on Friday March 4, 2016 will automatically receive one Crescita common share for each Nuvo Pharma common share purchased. Crescita common shares (TSX:CTX) are expected to commence trading on the TSX on Monday March 7, 2016. Nuvo Pharma and Crescita shareholders are encouraged to contact their brokers for additional information.

As part of the Reorganization, Nuvo has changed its name from "Nuvo Research Inc." to "Nuvo Pharmaceuticals Inc."