On May 14, 2018 FY2017 performance reflects superior execution (Press release, Takeda, May 14, 2018, View Source [SID1234526592])
– Underlying results: Revenue +5.5%, Core Earnings +40.2%, Core EPS +44.8%
– Takeda will maintain its underlying growth momentum in FY2018

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Underlying Revenue growth +5.5% led by Takeda’s Growth Drivers
• Underlying Revenue grew +5.5%, with Takeda’s Growth Drivers (Gastroenterology, Oncology, Neuroscience and Emerging Markets) posting strong underlying revenue growth of +12.8%.
• Broad based revenue performance was led by double digit growth in the U.S. (U.S. +13.5%, Japan -0.2%, Europe & Canada +6.7%, Emerging Markets +2.0%; Japan growth was +7.0% excluding returned portfolio)
• Reported revenue grew +2.2%, with underlying growth (+5.5%) and positive currency impact (+2.5pp), partly offset by the impact of divestitures (-5.8pp).

Stellar EPS growth reflects strong revenue growth and progress of Global Opex Initiative
• Underlying Core Earnings grew +40.2%, with the Core Earnings margin increasing by 420bps due to product mix improvement and strong cost discipline (+280bps gross margin; +160bps from OPEX margin). Reported operating profit was up +55.1%, mainly driven by Core Earnings growth. In FY2017, Takeda booked a large one-time gain of 106.3 billion yen from the sale of Wako; however, higher one-time expenses resulted in total other income/expenses being less favorable than prior year by-27.8 billion yen.
• Underlying Core EPS was up +44.8%, in-line with underlying Core Earnings growth. Reported EPS was 239 yen, an increase of +62.7% from 147 yen in the prior year, benefitting also from a lower tax rate due to re-measurement of deferred tax liabilities as a result of the U.S. tax reform.

Significant pipeline progress leveraging therapeutic area expertise
• 17 New Molecular Entity clinical stage-ups in FY2017, compared with 5 in the same period of the previous year. Important events included European Commission approval of ALOFISEL (darvadstrocel) in the area of GI, a label update for TRINTELLIX in neuroscience, and the initiation of Phase 3 for pevonedistat in oncology.
• Further strengthened innovation network with 56 new collaborations with academia and bio-tech/bio-ventures.

Net leverage improved due to continued strong progress on cash flow
• Operating Free Cash Flow was up +52.9% to 242.9 billion yen, higher than the dividend payment for the third consecutive year. Non-core asset sales generated an additional 164.4 billion yen of cash.
• Strong cash generation allowed rapid de-leveraging with the net debt/EBITDA ratio improving from 2.7x in March 2017 to 1.8x in March 2018.

Christophe Weber, President and Chief Executive Officer of Takeda, commented:

"Takeda’s transformation is delivering superior results as we execute against our key mid-term priorities of growing the portfolio, strengthening the pipeline, and boosting profitability. In FY2017, our Growth Drivers maintained their strong momentum, which together with disciplined cost management under the Global Opex Initiative resulted in industry-leading revenue and earnings growth. We also made significant progress in R&D, with 17 New Molecular Entity clinical trial stage-ups, and 56 new collaborations to strengthen our innovation network.
The strength of the underlying business means we expect to maintain revenue and earnings growth momentum in FY2018, and I am confident that through strategic focus and superior execution, Takeda will continue to deliver long-term value to patients and shareholders."

Core Earnings is calculated by deducting SG&A expenses and R&D expenses from reported Gross Profit. In addition, certain other items that are non-core in nature and significant in value may also be adjusted.

2 Underlying growth compares two periods of financial results on a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures.
3 Attributable to the owners of the company.

FY2018 Management Guidance: Maintaining underlying growth momentum
• Underlying revenue continues to grow despite negative headwinds of -4.4pp that include Velcade decline due to competitor entry (-3.5pp) and portfolio changes (-0.9pp).
• Continued product mix improvement and execution of the Global Opex Initiative will underpin margin improvement. Underlying Core Earnings margin to expand at lower end of the +100-200bps range bringing the 2-year margin expansion to more than 500 basis points.
• Underlying Core Earnings will grow high single digit, despite Velcade decline which negatively impacts Core Earnings growth by over 18 percentage points.
• Annual dividend of 180 yen per share, in-line with Takeda’s well-established dividend policy of being strongly committed to shareholder returns with the dividend as a key component.

FY2018 Reported Forecast: Underlying strength lessens impact of significant decline in one-time items
• Underlying revenue growth momentum offset by Forex and divestitures.
• Excluding the negative impact of Forex and divestitures, Core Earnings growth is forecast to be high single digit.
• Reported operating profit is impacted by lower other income (-40.9pp, especially the 106.3 billion yen gain on the sale of Wako in FY2017) and the impact of divestitures (-9.6pp).

Takeda is currently in an offer period (as defined in the City Code on Takeovers and Mergers (the "Code")) with respect to Shire plc. Pursuant to Rule 28 of the Code, statements made regarding Takeda’s guidance for FY2018 (including statements regarding forecasts for FY2018 revenue, Core Earnings, Operating profit, Profit before income taxes, Net profit attributable to owners of the Company, Basic earnings per share, R&D expenses, Amortisation and impairment and other income/expense, Underlying Revenue, Underlying Core Earnings and Underlying Core EPS) constitute a profit forecast for the year ending March 31, 2019 (the "Takeda Profit Forecast"). For additional information regarding the Takeda Profit Forecast and the required statement by its Directors that such profit forecast is valid and has been properly compiled on the basis of the assumptions stated and that the basis of accounting used in consistent with Takeda’s accounting policies, please see page 21 of Takeda’s Financial Results (Tanshin) for the Fiscal Year Ended March 31, 2018, dated May 14, 2018.

Raising our objectives for non-core asset disposals by the end of FY2018
• Revised objective is to unlock 190 billion yen of cash by the end of FY2018 from real estate disposals and the sale of securities, increased from 130 billion yen guidance given in May 2017.

On May 14, 2018 Eli Lilly and Company (NYSE: LLY) reported an agreement to acquire AurKa Pharma, Inc., a company established by TVM Capital Life Science to develop oncology compound AK-01, an Aurora kinase A inhibitor that was originally discovered at Lilly (Press release, Eli Lilly, MAY 14, 2018, View Source [SID1234526591]). The compound is a potential first-in-class asset that AurKa Pharma is studying in Phase 1 clinical trials in multiple types of solid tumors.

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Aurora kinases are believed to play a crucial role in cellular division by controlling chromosomal segregation. Defects in segregation can cause genetic instability, a condition highly associated with the formation of tumors. Aurora kinases, consisting of Aurora A, Aurora B and Aurora C, are key mitotic regulators required for genome stability and are frequently overexpressed in cancerous tumors. AurKa Pharma’s asset, AK-01, has been shown to be highly selective for Aurora A, with potential clinical benefit observed in Phase 1 studies. Future studies will seek to determine if the selectivity profile of AK-01 can improve efficacy while limiting toxicity risks to a manageable level.

After a review of its clinical pipeline priorities in 2016, Lilly sold the compound to TVM Capital Life Science, which then established AurKa as part of the TVM Life Science Ventures VII fund. The fund is a novel investment model that seeks to develop early-stage pharmaceutical assets in a capital-efficient manner. As part of its innovation strategy, Lilly actively participates with venture capital firms to source early stage opportunities.

"The acquisition of AurKa Pharma supports Lilly’s external innovation strategy, in which we seek to partner with leading life science venture capital firms in order to identify, support and access promising innovation in areas of unmet medical need," said Darren Carroll, senior vice president of corporate business development at Lilly. "We are excited with the value TVM created for this compound through its early-Phase studies, and we look forward to more opportunities in the future."

"Lilly Oncology is focused on the development of innovative cancer therapies that can make a meaningful difference for patients," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "The acquisition of AurKa Pharma expands our pipeline with a promising oncology compound targeting a distinct cell cycle pathway. The work done by AurKa will allow Lilly to leverage emerging data about cancers in which this molecule might be effective, and determine if it can be beneficial to people living with various forms of cancer."

"Through the unique healthcare venture capital model pioneered by TVM Capital Life Science, companies such as AurKa have been established to more quickly and efficiently bring promising compounds to clinical proof-of-concept," said Luc Marengere, Ph.D., Managing Partner at TVM Capital Life Science. "We are pleased that the scientific advances made by AurKa could contribute to the development of AK-01 and hopefully help deliver a potential new medicine for cancer patients."

Under the terms of the agreement, Lilly will acquire all shares of AurKa Pharma. In return, AurKa Pharma shareholders will receive an upfront payment of $110 million. AurKa Pharma shareholders are also eligible to receive up to $465 million in regulatory and sales milestones should AK-01 gain approval in the U.S. and other markets, and achieve certain sales levels.

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP), and is subject to customary closing conditions. There will be no change to Lilly’s 2018 non-GAAP earnings per share guidance as a result of this transaction.

Baird is acting as financial advisor to AurKa in this transaction.

On May 14, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, and Daiichi Sankyo Company, Limited (Daiichi Sankyo) reported that they entered into a new license agreement, building upon their 2016 cross-licensing and collaboration agreement (Press release, Zymeworks, MAY 14, 2018, View Source [SID1234526590]).

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"With a successful track record and our first bispecific antibody incorporating the Azymetric and EFECT technology having achieved a key research milestone in 2017, we look forward to adding two more bispecific compounds to our pipeline," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We are exceptionally impressed with the robust impact that Zymeworks’ technology brings to antibody development."

Under the terms of the second agreement, Daiichi Sankyo will acquire licenses to Zymeworks’ Azymetric and EFECT technology platforms to develop two additional bispecific antibody therapeutics. In exchange, Zymeworks will receive an upfront technology access fee of US$18 million and may receive up to US$466.7 million in potential clinical, regulatory and commercial milestone payments. In addition, Zymeworks will receive up to double-digit tiered royalties on global product sales.

"Expanding our relationship with a leading global pharmaceutical partner like Daiichi Sankyo is extremely satisfying as it underscores the power, versatility, and attractiveness of our technology platforms," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "Having already used our platforms to discover one bispecific antibody, Daiichi Sankyo now has increased access to our technology to create additional therapeutic candidates. We are pleased to be working with a healthcare pioneer with a proven track record of over 100 years of innovation leading to major breakthroughs in patient care."

Zymeworks and Daiichi Sankyo began working together in September 2016 through an agreement to develop one bispecific antibody therapeutic for which Zymeworks is eligible to receive preclinical, clinical, and commercial milestones payments, as well as up to double-digit tiered royalties on global product sales. Additionally, Zymeworks obtained a license to certain immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop, and commercialize multiple bispecific products globally in exchange for royalties on global product sales

On May 14, 2018 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late stage clinical trials for the treatment of patients with urological diseases, reported first quarter 2018 financial results (Press release, Sophiris Bio, MAY 14, 2018, View Source [SID1234526589]).

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"It has been an exciting quarter at Sophiris as we continue to make progress in advancing topsalysin," said Randall E. Woods, president and CEO of Sophiris. "We are looking ahead to two key events in 2018. By the end of the second quarter, we expect to announce the biopsy results from all patients receiving the first administration of topsalysin in our Phase 2b study, and by the end of the year, we expect complete data from all patients including those patients who received a second administration of topsalysin. In advance of these milestones, we have been actively preparing for a Phase 3 registration study, including engaging in initial discussions with European regulatory agencies. In addition, we are actively moving forward with our manufacturing plans to provide sufficient drug substance for a potential Phase 3 registration study in localized prostate cancer and also a potential second Phase 3 in BPH."

Upcoming Milestones:

Advancement of Phase 2b Localized Prostate Cancer Study. The Company announced in December 2017 that it had completed enrollment in its Phase 2b localized prostate cancer study to evaluate the safety and tolerability of topsalysin in treating men with clinically significant localized prostate cancer. A total of 38 patients have been treated with topsalysin in the study. The Company expects biopsy data from all patients receiving the first dose of topsalysin to be available by the end of the second quarter for 2018.

During the first quarter of 2018, the independent data monitoring committee (IDMC) for the Phase 2b trial met to review the reported adverse events from all patients after the first administration of topsalysin. The IDMC unanimously recommended the clinical trial continue without changes to the protocol. The Company believes that topsalysin continues to demonstrate a favorable safety profile.

The Phase 2b study was designed to include an option to re-treat patients who did not have any clinically significant adverse events and who responded to the first administration of topsalysin but still had a clinically significant lesion. These patients will have the option to receive a second administration of topsalysin followed by an additional, targeted biopsy six months following the second administration. The Company expects to have final biopsy data in the fourth quarter of 2018 from all patients who receive a second administration. This will be the first data potentially supporting repeat administration of topsalysin.

Financial Results:

At March 31, 2018, the Company had cash, cash equivalents and securities available-for-sale of $22.1 million and working capital of $19.2 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations to the middle of 2019, assuming no new clinical trials are initiated. The Company reported a net loss of $3.3 million or $(0.11) per share for the three months ended March 31, 2018, compared to a net loss of $2.6 million or $(0.09) per share for the three months ended March 31, 2017.

Research and development expenses

Research and development expenses were $3.3 million for the three months ended March 31, 2018, compared to $1.2 million for the three months ended March 31, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, an increase in clinical costs associated with our Phase 2b clinical trial of topsalysin for the focal treatment of localized prostate cancer.

General and administrative expenses

General and administrative expenses were $1.2 million for the three months ended March 31, 2018, compared to $1.4 million for the three months ended March 31, 2017. The decrease in general and administrative expense is primarily due to a decrease in non-cash stock-based compensation expense which was partially offset by an increase in professional services.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $1.4 million for the three months ended March 31, 2018, compared to a loss of $86,000 for the three months ended March 31, 2017. As these warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for these warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. The non-cash gain reported for the three months ended March 31, 2018, is associated with a decrease in the fair value of the Company’s warrant liability from December 31, 2017, to March 31, 2018, which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

On May 14, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ:MBIO), a Fortress Biotech (NASDAQ:FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR-T) technology, reported financial results for the first quarter ended March 31, 2018 (Press release, Mustang Bio, MAY 14, 2018, View Source [SID1234526588]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In the first quarter of 2018, Mustang continued to execute on our strategy of developing a portfolio of differentiated CAR-T therapies for patients with aggressive forms of cancer. We are pleased to report significant progress on the build-out of our proprietary CAR-T cell processing facility at UMass Medicine Science Park in Worcester, Mass., which is on track to be fully operational and ready to process cells by the end of the year. We are also transitioning two preclinical CAR-T programs at City of Hope into the clinic in 2018, and plan to file our first Investigational New Drug Application during the fourth quarter. In March, we were delighted to announce the promotion of Sadik Kassim, Ph.D., to Chief Scientific Officer, and Knut Niss, Ph.D., to Chief Technology Officer, and look forward to continuing to work together to innovate in cell processing and to explore opportunities to leverage best-in-class science to strengthen our CAR-T pipeline. To this end, we will expand our internal research capabilities and plan to hire a team of scientists that will be fully dedicated to preclinical and translational research efforts."

Financial Results:

As of March 31, 2018, Mustang’s consolidated cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $55.3 million, compared to $61.5 million as of December 31, 2017, a decrease of $6.2 million for the quarter.
Research and development expenses were $4.3 million for the first quarter of 2018, compared to $0.7 million for the first quarter of 2017. Non-cash, stock-based compensation expenses included in research and development were $1.5 million for first quarter of 2018, compared to $0 million for the first quarter of 2017.
Research and development expenses from license acquisitions totaled $0.1 million for the first quarter of 2018, compared to $0.6 million for the first quarter of 2017.
General and administrative expenses were $2.1 million for the first quarter of 2018, compared to $2.0 million for the first quarter of 2017. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.5 million for the first quarter of 2018, compared to $1.2 million for the first quarter of 2017.
Net loss attributable to common stockholders was $6.3 million, or $0.24 per share, for the first quarter of 2018, compared to $3.2 million, or $0.14 per share, for the first quarter of 2017.