On May 10, 2016 Takeda reported results for Fiscal Year 2015 (April 2015 -March 2016) and Forecast for Fiscal Year 2016 (Press release, Takeda, MAY 10, 2016, View Source [SID:1234512192]).

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FY2015: A year of turnaround to sustained growth; achieved full year management guidance
Underlying revenue up +3.4% (reported revenue growing +1.7% to 1,807.4 billion yen), led by strong performances in Takeda’s growth drivers (GI, Oncology, CNS and Emerging Markets)
Underlying Core Earnings up +8.1% (reported operating profit recorded 130.8 billion yen), aided by cost discipline
Underlying Core EPS up +21.7% (reported EPS was 102 yen), growing 2.5x faster than underlying core earnings
Growth Drivers continued to be robust
Consolidated underlying revenue growth of Gastroenterology (GI), Oncology, Central Nervous System (CNS) and Emerging Markets – Takeda’s Growth Drivers – was +9.5% year-to-year
Underlying revenue of GI +23.6%, Oncology +1.0%* and CNS +37.3% year-to-year
Emerging Markets underlying revenue +4.8% year-to-year with continued growth in the key markets of China, Russia and Brazil
*Underlying growth of Oncology excluding VELCADE royalties was +4.4%

Broad portfolio of growing products offsets loss of exclusivity decline
ENTYVIO is on track to exceed $2 billion MAT* sales within FY2018
Encouraging uptake of NINLARO and TAKECAB
BRINTELLIX and ADCETRIS showed continued growth
AZILVA and LOTRIGA are contributing to the Japan business
*Moving Annual Total @ constant currency

Efficiency gains continue
Project Summit well exceeded full-year target resulting in 30 billion yen additional cost savings
Strong cash flow performance with Operating Free Cash Flow, excluding Actos settlement payment, reaching 230 billion JPY
FY2016 management guidance: A year of strategic focus to sustain growth
Underlying Revenue: Mid-single digit growth (%)
Underlying Core Earnings: Low- to mid-teen growth (%)
Underlying Core EPS: Low- to mid-teen growth (%)
Christophe Weber, President and Chief Executive Officer of Takeda, commented:
"FY2015 was a turnaround year. We achieved our management guidance for the second consecutive year, led by our growth drivers, and aided by the global launches of new products such as ENTYVIO and NINLARO. Takeda will continue to deliver innovative new medicines to patients, especially in our focused R&D therapeutic areas. Takeda aims to relentlessly execute our strategic roadmap to deliver our long-term aspiration, and will serve the needs of the patients, with the best in class agility and innovation."

Key figures for the full year of FY2015 (April 2015 –March 2016)

FY 2014
FY 2015
Growth
billion yen

Underlying2
Revenue
1,777.8
1,807.4
+1.7%
+3.4%
Operating Profit
-129.3
130.8
–
–
Core Earnings1
288.3
292.4
+1.4%
+8.1%
Net Profit3
-145.8
80.2
–
–
EPS
-185 yen
102 yen
–
–
Core EPS
225 yen
258 yen
+14.8%
+21.7%
1 Core Earnings is calculated from operating profit by excluding the impact of exceptional items, such as purchase accounting, amortization and impairment loss of intangible assets, restructuring costs and major litigation costs.
2 Underlying performance aims at understanding the real performance of the business. Underlying Revenue, Underlying Core Earnings, and Underlying Core EPS exclude the same as above and adjusted for acquisitions/divestments and foreign exchange.
3 Attributable to the owners of the company

Underlying revenue growth was mainly driven by Takeda’s Growth Drivers: Gastroenterology(GI), Oncology, and Central Nervous System (CNS) in addition to Emerging Markets. The Growth Drivers account for 52% of Takeda’s revenue. GI revenue grew by +23.6% year-to-year, driven by ENTYVIO. Oncology revenue increased by +1.0%, contributed by VELCADE, ADCETRIS and NINLARO, which has shown an encouraging start in the U.S. since it was launched in December,. Oncology revenue excluding VELCADE royalties grew +4.4%. CNS revenue, including BRINTELLIX, increased by +37.3%. Emerging Markets revenue grew by +4.8% year-to-year, led by Value Brands (branded generics and Over-The-Counter medicines), with steady growth in China (+11.1%), Russia (+6.2%) and Brazil (+5.7%). However, our future aspiration for growth in Emerging Markets remains strong, in high single digits. Performance in the U.S. (+12.4% year-to-year underlying revenue growth) also contributed to total revenue growth. In Japan, which remains under increasing generic pressure, underlying revenue declined -3.3% year-to-year, but AZILVA and LOTRIGA showed significant sales growth of +30.1% and +69.0%, respectively, year-to-year. In addition to these growing products, TAKECAB and ZAFATEK are expected to be key sales drivers in Japan after the lifting of the 2-week limit on the prescription period.

Consolidated operating profit was 130.8 billion yen, an increase of 260.1 billion yen compared to the previous year, which exceeded the raised forecast of 120 billion yen announced in February at the FY2015 3rd quarter earnings announcement. Selling, general and administrative expenses increased by 38.2 billion yen (+6.2%) compared to the previous year, mainly due to the increase in sales expenses related to new products in the U.S., but R&D expenses decreased by 36.2 billion yen (-9.5%). Amortization and impairment losses on intangible assets associated with products decreased by 51.3 billion yen (-29.1%), mainly due to 30.5 billion yen of COLCRYS impairment loss being recognized in 2014 compared to an 8.6 billion yen impairment reversal in fiscal 2015. Other operating income decreased by 82.1 billion yen (-76.6%), mainly due to 53.8 billion yen of revaluation of COLCRYS contingent consideration liability and 32.8 billion yen of the gains on sales of real estate being recognized in the previous year. Other operating expenses decreased by 277.8 billion yen (-86.2%), mainly due to 274.1 billion yen of loss on Actos litigation in the U.S. being recognized in the previous year.

Project Summit – a company-wide strategic initiative to increase efficiency – continued to produce results, with 30 billion yen of additional savings in FY2015, exceeding the full year target as a result of higher Procurement savings.

As part of its ongoing effort to improve R&D productivity, Takeda is focusing on its core therapeutic areas of Oncology, GI and CNS. Takeda will further strengthen its initiatives and commitment to lead innovation in medicines and provide innovative new drugs to patients around the world including in emerging markets.

FY2015 was positioned for Takeda as a year of turnaround to sustained growth, and Takeda sets the following management guidance for FY2016 as a year of strategic focus to sustain growth.

Management Guidance for FY2016

Underlying Growth (%)
Underlying Revenue
Mid-single digit
Underlying Core Earnings
Low- to mid-teen
Underlying Core EPS
Low- to mid-teen
Dividend per Share
180 yen
Reported Forecast for FY2016 (change vs. FY2015 results)

billion yen
FY 2016 1
Change
Revenue
1,720.0
-4.8%
R&D expenses
325.0
-6.0%
Operating Profit
135.0
+3.2%
Net Profit 2
88.0
+9.8%
EPS
112 yen
+9.8%
1 The exchange rate assumptions for FY2016 are 1US$=110 yen and 1 euro=125 yen
2 Attributable to the owners of the company

For more details on Takeda’s FY2015 full year results and other financial information, please visit View Source

About Takeda Pharmaceutical Company Limited

On May 10, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, reported its financial and operational results for the first quarter of 2016 (Press release, ProNAi Therapeutics, MAY 10, 2016, View Source [SID:1234512182]).

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"During the first quarter, we continued to advance our lead cancer drug, PNT2258, in two Phase 2 trials, Wolverine and Brighton, and we remain on track to report interim data from the Wolverine trial in third-line diffuse large B-cell lymphoma (DLBCL) in June 2016," said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. "In addition, we continued to evaluate novel drug candidates for potential licensing or acquisition, with the vision of establishing a broad and diversified pipeline under our development. Supporting this vision, in the first quarter we further strengthened ProNAi’s core infrastructure by adding two industry veterans to our Board of Directors, Mr. Jeffrey H. Cooper and Mr. Tran Nguyen, and by opening an office in the San Francisco area where our world-class clinical development team resides led by Dr. Barbara Klencke."

First Quarter 2016 Financial Results (all amounts reported in U.S. currency)
Total operating expenses for the three months ended March 31, 2016 were $10.6 million compared to $6.7 million for the three months ended March 31, 2015. Total operating expenses included non-cash stock based compensation of $1.4 million and $0.2 million for the three months ended March 31, 2016 and 2015, respectively.

Research and development expenses increased to $6.6 million for the three months ended March 31, 2016 from $5.3 million for the three months ended March 31, 2015. These increases were primarily due to expenses related to the continuation of our PNT2258 clinical trials and an increase in personnel-related costs. These increased costs were partially offset by a decrease in third-party manufacturing costs for PNT2258.

General and administrative expenses increased to $4.0 million for the three months ended March 31, 2016 from $1.4 million for the three months ended March 31, 2015. These increases were primarily due to increased personnel-related costs and professional fees incurred in support of activities as a public company and corporate growth, and costs pertaining to business development activities.

For the three months ended March 31, 2016, ProNAi incurred a net loss of $10.5 million compared to a net loss of $8.0 million for the three months ended March 31, 2015. The net loss included a non-cash charge related to the change in fair value of preferred stock warrants of $1.3 million for the three months ended March 31, 2015.

At March 31, 2016, ProNAi had $140.9 million in cash and cash equivalents compared to $150.2 million in cash and cash equivalents at December 31, 2015.

At March 31, 2016, there were 30,174,778 shares of common stock issued and outstanding and stock options to purchase 4,153,460 shares of common stock issued and outstanding.

On May 10, 2016 Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, reported recent highlights and developments as well as financial results for the first quarter of 2016 (Press release, Omeros, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2166828 [SID:1234512179]). These include:

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1Q 2016 revenues were $7.4 million, an 11% increase over 4Q 2015.
Net loss in 1Q was $20.5 million, or $0.54 per share, which included $4.7 million ($0.12 per share) of non-cash expenses.
OMIDRIA units shipped by wholesalers ("sell-through") increased 20% over 4Q 2015.
OMIDRIA sales accelerated substantially in the second half of 1Q, with March accounting for nearly 50% of quarterly sales.
OMIDRIA sales growth trajectory has continued into 2Q with sales to date approximately 65% higher than the corresponding period in 1Q.
Based on recent sales activity, net sales of OMIDRIA, without any additional growth, annualize to an approximate run rate of $45 million to $50 million.
Entered into sales agreement for OMIDRIA in the Middle East in May 2016.
Initiated Phase 3 program of OMS721 for treatment of atypical hemolytic uremic syndrome (aHUS), with patient enrollment expected later this year, and commenced patient dosing in OMS721 Phase 2 program in complement-related, corticosteroid-dependent renal diseases.
"OMIDRIA sales continued to grow substantially in Q1," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Growth in the first part of the quarter was relatively restrained due to both internal and external factors, with sales markedly ramping in March. The acceleration in sales growth has continued into the second quarter, with the run rate for OMIDRIA net sales in recent weeks annualizing to approximately $45 million to $50 million. We continue to expect that we will reach cash-flow positive status later this year, fully funding our pipeline. That pipeline continues to advance, with OMS721 entering a Phase 3 program for aHUS and two OMS721 Phase 2 trials ongoing in TMAs and renal disease. The remainder of the pipeline is progressing nicely, and 2016 is shaping up to hold a number of value-driving milestones."

First Quarter and Recent Highlights and Developments

Highlights and developments regarding OMS721, the company’s lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS), include:
Omeros initiated a Phase 3 OMS721 program that will consist of one clinical trial – a single-arm (i.e., no control arm), open-label trial in patients with newly diagnosed or ongoing aHUS. Phase 3 enrollment is expected to begin later this year and patients currently being treated in the Phase 2 trial are likely to be included in the Phase 3 program. Omeros also plans to pursue accelerated approval for OMS721 in aHUS.
In the company’s Phase 2 clinical program evaluating OMS721 in patients with complement-related renal disorders, Omeros initiated dosing in a new Phase 2 clinical trial that includes patients with corticosteroid-dependent IgA nephropathy, membranous nephropathy, C3 glomerulopathy and lupus nephritis.
Physicians in Finland, based on review of OMS721 data, requested access to OMS721 under a Special License, granted by the Finnish regulatory authorities, for compassionate use in a patient with aHUS. The patient was previously treated with Soliris (eculizumab) but did not have an adequate response according to the requesting physicians and was continuing to display signs of active aHUS.
Omeros and ITROM Trading Drug Store (ITROM) entered into an exclusive supply and distribution agreement for the sale of OMIDRIA in the Kingdom of Saudi Arabia, the United Arab Emirates and certain other countries in the Middle East. Based in Dubai and internationally recognized, ITROM markets, sells and distributes ophthalmic pharmaceutical products in the Middle East. Under the agreement, ITROM will be responsible for obtaining marketing authorizations for OMIDRIA within the licensed territory in addition to marketing and distributing OMIDRIA supplied by Omeros. Omeros expects ITROM to begin selling OMIDRIA later this year.
In March 2016, Omeros was granted by the U.S. Patent and Trademark Office a fourth OMIDRIA patent directed to methods of use. Omeros amended its patent infringement lawsuit against Par Pharmaceutical to assert this additional patent.
A U.S. Patent was granted to Omeros that is directed to the use of any phosphodiesterase-7, or PDE7, inhibitor to treat any substance addiction or any addictive or compulsive behavior. Omeros expects to advance its OMS527 PDE7 inhibitor program into the clinic in 2017.
As previously reported, Omeros converted 26 of its previously contracted OMIDRIA field sales representatives to Omeros employees effective January 1, 2016. In connection with the conversion, the company also hired 11 additional sales representatives during the first quarter. In January 2016, Omeros also entered into a commission-only contract sales agent agreement with Precision Lens to cover "square" states in the Midwest that were not previously covered by the company’s sales force. Both the additional representatives and Precision Lens began making sales calls in February.
Financial Results

For the quarter ended March 31, 2016, total revenues were $7.4 million with OMIDRIA revenue of $7.2 million and grant revenue of $173,000. This compares to OMIDRIA revenues of $238,000 and grant revenue of $150,000 for the same period in 2015. OMIDRIA units sold by the company’s wholesalers to ambulatory surgery centers (ASCs) and hospitals increased 20% from the fourth quarter of 2015.

Sales were restrained in the first half of 1Q, likely due to a number of factors including: low cataract surgery procedural volumes in the first quarter of each year; a series of large ophthalmology annual meetings attracting high-volume cataract surgeons; and Omeros’ conversion of two-thirds of its contract to an in-house sales force and filling out the remaining one-third of the sales force with additional direct hires who began making sales calls in February. Also in February, our commission-only sales agents from Precision Lens, covering states in the Midwest, began making sales calls.

OMIDRIA sales accelerated substantially in the second half of 1Q, with March accounting for nearly 50% of quarterly sales. OMIDRIA sales growth trajectory has continued into 2Q with sales to date approximately 65% higher than the corresponding portion of 1Q. Based on recent sales activity, net sales of OMIDRIA, without any additional growth, annualize to an approximate run rate of $45 million to $50 million.

Total costs and expenses for the three months ended March 31, 2016 were $26.9 million ($4.7 million of noncash expenses) compared to $18.3 million ($2.8 million of noncash expenses) for the same period in 2015. The increase in the current year quarter was primarily due to increased OMS721 research and development activities and non-cash stock-based compensation costs associated with the annual company-wide option grants approval and pricing in February 2016 with retroactive vesting commencement dates of April 2015.

For the three months ended March 31, 2016, Omeros reported a net loss of $20.5 million, or $0.54 per share, which included noncash expenses of $4.7 million ($0.12 per share). This compares to a net loss of $18.7 million, or $0.51 per share, for the same period in 2015, which included noncash expenses of $2.8 million ($0.08 per share).

At March 31, 2016, the company had cash, cash equivalents and short-term investments of $13.2 million. In addition, the company had $10.7 million of restricted cash on hand to satisfy covenants under its loan agreement with Oxford Finance and East West Bank and its lease for the Omeros Building.

On May 10, 2016 GTx, Inc. (Nasdaq: GTXI) reported financial results for the first quarter ended March 31, 2016, and highlighted recent accomplishments and upcoming milestones (Press release, GTx, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2166792 [SID:1234512174]). The Company is currently enrolling patients in three clinical trials: two trials evaluating enobosarm as a potential treatment for women with advanced breast cancer and another assessing enobosarm as a potential treatment for stress urinary incontinence in postmenopausal women.

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"During the first quarter, we executed on several ongoing initiatives that we expect will make 2016 a year of considerable progress," said Dr. Robert J. Wills, Executive Chairman of GTx. "We have continued to make progress in the enrollment of our two advanced breast cancer clinical trials of enobosarm, with preliminary data from the first stage of each study expected by the end of 2016. Also, we are excited to be collaborating with doctors on a clinical trial that is the first clinical study to use a SARM to treat stress urinary incontinence in postmenopausal women and expect data from this study late in 2016."

Corporate Highlights and Anticipated Milestones

Enobosarm in Breast Cancer: The Company’s lead product candidate, a selective androgen receptor modulator (SARM), is being developed as a targeted treatment for two advanced breast cancer indications: (i) estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer (TNBC). For both clinical trials, the primary efficacy endpoint will be clinical benefit, which is defined as a complete response, partial response or stable disease.

ER+/AR+ breast cancer: We currently expect to complete enrollment in the first stage of the open-label, Phase 2 clinical trial of enobosarm in women with metastatic or locally advanced ER+/AR+ breast cancer in the second quarter of 2016, to allow us to determine during the fourth quarter of this year whether there is sufficient safety and efficacy data to warrant proceeding with the second stage of the clinical study. While the first stage of the trial will evaluate 18 patients for each of the two dosing arms, 9 mg and 18 mg of enobosarm, the trial is designed to enroll up to 118 patients to obtain data from 44 evaluable patients in each study arm (a total of 88 evaluable patients) to assess the primary efficacy objective of clinical benefit response following 24 weeks of treatment.
AR+ TNBC: We currently expect to complete enrollment in the first stage of the open-label, proof-of-concept Phase 2 clinical trial of 18 mg of enobosarm in women with advanced AR+ TNBC in the third quarter of 2016, to allow us to determine by the end of 2016 whether there is sufficient safety and efficacy data to warrant proceeding with the second stage of the clinical study. While the first stage will include 21 evaluable patients, the trial is designed to enroll up to 55 patients in total in order to obtain data from 41 evaluable patients to assess the primary efficacy objective of clinical benefit response following 16 weeks of treatment.
SARMs in Non-Oncologic Indications: The Company is exploring SARMs as potential treatments for both stress urinary incontinence (SUI) and Duchenne muscular dystrophy (DMD), a rare disease characterized by progressive muscle degeneration and weakness.

SUI: We are currently enrolling patients in a Phase 2 proof-of-concept clinical trial of 3 mg of enobosarm to treat up to 35 postmenopausal women with SUI, the first clinical trial to evaluate a SARM for SUI. Top-line data from the Phase 2 clinical trial is anticipated by the end of 2016.
DMD: The Company’s preclinical studies have continued to confirm beneficial effects from SARMs in mice genetically altered to simulate DMD, compared to control groups. The Company continues to advance its preclinical initiatives while pursuing a strategic collaboration with potential biopharma partners experienced in orphan drug development.
SARDs in Prostate Cancer: Our Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies. The Company believes that its SARD compounds will degrade multiple forms of the androgen receptor, including AR splice variants, such as AR-V7.

CRPC: Several lead SARD compounds are currently being evaluated in preclinical studies to select the best SARD compounds for continued development, as well as to develop data necessary to initiate first in human clinical trials in 2017.
First Quarter 2016 Financial Results

As of March 31, 2016, cash and short-term investments were $24.3 million compared to $29.3 million at December 31, 2015.
Research and development expenses for the quarter ended March 31, 2016 were $4.0 million compared to $2.9 million for the same period of 2015.
General and administrative expenses were $2.1 million for both the quarter ended March 31, 2016 and March 31, 2015.
The Company recognized a non-cash gain of $8.2 million and $2.6 million for the quarter ended March 31, 2016 and 2015, respectively, due to the change in fair value of the Company’s warrant liability. During the first quarter of 2016, the Company recorded a non-cash reclassification of this warrant liability to stockholders’ equity due to the modification of these warrants. No adjustments to the fair value of these warrants will be made in the future.
Net income for the quarter ended March 31, 2016 was $2.1 million compared to a net loss of $2.4 million for the same period in 2015. Net income for the quarter ended March 31, 2016 included the non-cash gain of $8.2 million related the revaluation of our warrant liability. The net loss for the quarter ended March 31, 2015 included a non-cash gain of $2.6 million related to the change in the fair value of the Company’s warrant liability.
GTx had approximately 141.7 million shares of common stock outstanding as of March 31, 2016. Additionally, there remain warrants outstanding to purchase approximately 64.3 million shares of GTx common stock at an exercise price of $0.85 per share.

On May 10, 2016 Genmab reported its Interim Report for the First Quarter of 2016 (Press release, Genmab, MAY 10, 2016, View Source [SID:1234512173]).

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Net Sales of DARZALEX (daratumumab) by Janssen for the first quarter of 2016 were USD 101.9 million, resulting in royalty income of DKK 83 million
Announced positive interim result in Phase III Castor study of daratumumab in relapsed or refractory multiple myeloma
Announced studies of daratumumab in combination with atezolizumab in a solid tumor and multiple myeloma
Achieved USD 5 million milestone for progress in the Phase II study of daratumumab in non-Hodgkin’s lymphoma (NHL) under collaboration with Janssen

Announced updated development plans for ofatumumab in autoimmune indications
U.S. Food and Drug Administration (FDA) Approval of Arzerra (ofatumumab) as extended treatment for recurrent or progressive chronic lymphocytic leukemia (CLL)
U.S. and EU regulatory submissions for ofatumumab in combination with fludarabine and cyclophosphamide for relapsed CLL
"The first quarter of 2016 saw continued rapid progress in the development of daratumumab with Janssen: We reported positive interim data in the Phase III Castor study of daratumumab in combination with bortezomib and dexamethasone, achieved the second milestone in the Phase II NHL study, and announced the first study to combine daratumumab with Roche’s anti-PDL1 antibody atezolizumab, in a solid tumor and multiple myeloma. We also started off the year with a number of achievements under our Arzerra collaboration with Novartis. Arzerra was approved in the U.S. as extended treatment for recurrent or progressive CLL and regulatory submissions for ofatumumab in combination with fludarabine and cyclophosamide in relapsed CLL were submitted in the U.S. and Europe. Furthermore, we announced that development of the subcutaneous formulation of ofatumumab in autoimmune indications will be focused on relapsing multiple sclerosis, with large Phase III studies run by Novartis expected to start later this year," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter
Revenue was DKK 170 million in the first quarter of 2016 compared to DKK 107 million in the first quarter of 2015. The increase of DKK 63 million, or 59%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.

Operating expenses were DKK 154 million in the first quarter of 2016 compared to DKK 110 million in the first quarter of 2015. The increase of DKK 44 million, or 40%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.

Operating income was DKK 16 million in the first quarter of 2016 compared to DKK 173 million in the first quarter of 2015. The decrease of DKK 157 million was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015 combined with increased operating expenses, which were partly offset by higher revenue.

On March 31, 2016, Genmab had a cash position of DKK 3,491 million, similar to the cash position of DKK 3,493 million at December 31, 2015.

Business Progress First Quarter to Present
Daratumumab
March: Announced that the Phase III Castor study (MMY3004) of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint of improving progression free survival (PFS) in a planned interim analysis (p<0.0001). Janssen will engage in a dialogue with the health authorities about the potential for these data to serve as the basis for a regulatory submission.

March: Announced that daratumumab will be investigated in Phase Ib clinical studies in combination with atezolizumab, an anti-PD-L1 antibody, in a solid tumor and multiple myeloma. The studies will be conducted under a collaboration agreement between Janssen Biotech, Inc. (Janssen) and Genentech, a member of the Roche Group.

March: Achieved the second milestone in the ongoing Phase II study of daratumumab in NHL, triggering a USD 5 million payment from Janssen.

Ofatumumab
March: Announced that supplemental regulatory applications for the use of Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL were submitted in the U.S. and EU by Novartis.

March: Announced an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple sclerosis following the transfer of the rights to ofatumumab in this disease area from GlaxoSmithKline (GSK) to Novartis at the end of 2015. Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis are expected to be initiated by Novartis during the second half of 2016. The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK, will be discontinued.

January: The U.S. FDA approved a supplemental Biologics License Application (sBLA) for the use of Arzerra for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.

Subsequent Events
April: Reported additional data from the Phase III Castor study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The study met the primary endpoint of improving PFS; Hazard Ratio (HR) = 0.39, p<0.0001. The median PFS for patients treated with daratumumab has not been reached, compared to median PFS of 7.2 months for patients who did not receive daratumumab. Data from this study was accepted for oral presentation in a Plenary Session at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

April: Announced that MorphoSys filed a complaint at the U.S. District Court of Delaware against Genmab and Genmab’s collaboration partner Janssen, for patent infringement under U.S. patent no. 8,263,746 based on activities relating to the manufacture, use and sale of DARZALEX in the United States. Genmab and Janssen disagree with the allegations made by MorphoSys in its complaint for patent infringement related to CD38 antibodies and intend to vigorously contest those allegations.
April: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorization for DARZALEX intended for the treatment of relapsed and refractory multiple myeloma. The recommendation is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

Outlook
Genmab is maintaining its 2016 revised financial guidance published on April 20, 2016.