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 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2016 (Press release, Calithera Biosciences, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2167159 [SID:1234512234]). As of March 31, 2016, cash, cash equivalents and investments totaled $68.3 million.

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"During the first quarter, we continued to advance our development pipeline by recruiting patients into clinical studies of CB-839, and preparing for an Investigational New Drug (IND) application for CB-1158, as well as expanding our clinical leadership team," said Susan Molineaux, Ph.D., President and Chief Executive Officer of Calithera. "More recently, at the 2016 American Association of Cancer Research annual meeting, we and our collaborators presented four abstracts highlighting synergy studies of CB-839 and CB-1158. CB-839 is currently enrolling multiple combination cohorts in our Phase Ib clinical trials, for which updates are planned in June."

First Quarter 2016 and Recent Highlights

Enrollment continues across CB-839 Phase Ib combination cohorts. Data from the Phase I solid tumor trial has been accepted for presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Initial results of CB-839 in combination with paclitaxel in patients with triple negative breast cancer will be presented in a poster and discussion on June 5, 2016. Initial results of CB-839 alone and in combination with everolimus in patients will renal cell carcinoma will be presented in a poster on June 6, 2016.
CB-839 preclinical findings, including combinations with immuno-oncology therapies, presented at the American Association of Cancer Research. In April 2016, Calithera presented preclinical data for CB-839 in combination with immuno oncology-agents. The combination of CB-839 and anti-PD-L1 or anti-PD-1 substantially increased the number of tumor regressions seen in the CT26 syngeneic colon carcinoma model. Synergistic effects with CB-839 and anti-PD-L1 were also observed in a B16 melanoma model. Both of these agents are known to affect metabolism in the tumor microenvironment. Treatment with anti-PD-1 or PD-L1 increases glucose metabolism in T cells and CB-839 increases the amount of glutamine available for T cells because it inhibits the avid metabolism of glutamine by the tumor itself. T cells require adequate levels of these two key nutrients to expand and mount a strong anti-tumor response.
CB-1158 preclinical findings presented at the American Association of Cancer Research. CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, demonstrated single agent efficacy in animal models. Inhibition of tumor growth was accompanied by an increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment. CB-1158 increased CD8+ T-cell infiltrates in a lung tumor model. The addition of CB-1158 to anti-CTLA-4 and anti-PD-1 significantly inhibited tumor growth and reduced metastases in a mouse model that was resistant to dual checkpoint inhibitor therapy. CB-1158 was well tolerated as a single agent and in combination with checkpoint inhibitors in animal studies.
Key hire and promotion in clinical group. Calithera announced today the expansion of its clinical group with the hiring of Sam Whiting, M.D., Ph.D. as Vice President of Clinical Development. Most recently, Dr. Whiting served as Vice President of Research and Clinical Development at Gradalis, Inc. Previously Dr. Whiting was an assistant member at the Fred Hutchinson Cancer Research Center (FHCRC), and assistant professor at the University of Washington where he was clinical director of gastrointestinal oncology. Dr. Whiting received his M.D. and Ph.D. degrees and completed his internal medicine residency at the University of Washington, and medical oncology fellowship at the FHCRC. Keith Orford, M.D., Ph.D., who joined Calithera in January 2015, has been promoted to Senior Vice President of Clinical Development.
Selected First Quarter 2016 Financial Results

Research and development expenses were $7.1 million for the three months ended March 31, 2016, compared with $5.6 million for the same period in the prior year. The increase of $1.4 million was primarily attributed to increased development activities in Calithera’s arginase inhibitors program as it plans to file an IND in mid-2016, partially offset by a decrease of $0.4 million related to Calithera’s licensing arrangements.

General and administrative expenses were $2.6 million for the three months ended March 31, 2016, compared with $2.2 million for the same period in the prior year. The increase of $0.4 million was primarily due to higher employment related expenses, including stock-based compensation expense.

Net loss from operations for the three months ended March 31, 2016 was $9.6 million.

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.

CAR-T cell(Chimeric Antigen Receptor modified T cells) therapy is a newly emerging cellular immunotherapy technology (Company Web Page, Sinobioway Bioeconomy Group , MAY 10, 2016, View Source;second_id=3002 [SID:1234512236]). With molecular biological methods, it combines together the antibody fragment that identifies tumor-associated antigen(scFv), components of T cell receptor(CD3 ζ), costimulatory signal molecules for T cell activation(CD28, CD137 etc.) and junction fragments, to construct the chimeric antigen receptor(CAR). Then it introduces CAR into T cells by gene engineering techniques, thus acquiring the target killing capacity independent of MHC pathway.

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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