On May 13, 2019 BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the UBS Global Healthcare Conference in New York, NY on Monday, May 20, 2019 at 11:30 a.m. ET (Press release, Alexion, MAY 13, 2019, View Source [SID1234536219]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

On May 13, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502)(NYSE:TAK): FY2018 Full Year Results (Press release, Takeda, MAY 13, 2019, View Source [SID1234536236]).

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Legacy Takeda Underlying Revenue +5.3%; Consolidated reported revenue +18.5%

Underlying Revenue growth for Legacy Takeda was solid at +5.3%, with significant contributions from key growth products such as ENTYVIO (+34.8%) and NINLARO (+36.1%).
Consolidated reported revenue increased +18.5% to 2,097.2 billion yen. This was mainly due to the inclusion of Legacy Shire’s results from January 8, 2019, which was offset by the one-time negative impact from applying Takeda’s distribution channel policies to Legacy Shire products.
Legacy Takeda Underlying Core Earnings margin expanded +540 basis points

Legacy Takeda underlying Core Earnings grew +38.7%, with Opex discipline driving three fourths of the +540bps margin expansion. Legacy Takeda’s underlying Core Earnings margin has now expanded +960bps based on simple addition of gains in the last two years, driven by key growth products and execution of the Global Opex Initiative.
Legacy Takeda operating profit grew +70.3% mainly driven by business momentum. Large one-time gains in FY2017 from the divestiture of Wako Pure Chemical and the transfer of additional products to the Teva JV were matched by increased gains on sales of real estate and the divestitures of Multilab and Techpool in FY2018.
Consolidated reported operating profit decreased -15.2% to 205.0 billion yen, and consolidated reported EPS declined -52.6% to 113 yen per share, mainly impacted by significant non-cash purchase accounting expenses. The strong performance in Legacy Takeda reported operating profit entirely absorbed Shire acquisition-related costs incurred in FY2018.
Innovative R&D engine delivered important pipeline milestones

ENTYVIO demonstrated superior efficacy versus adalimumab in ulcerative colitis head-to-head VARSITY study4. Regulatory applications for a subcutaneous formulation filed in the U.S. for ulcerative colitis and Europe for ulcerative colitis and Crohn’s disease.5
Approvals in FY2018 for TAKHZYRO in the U.S. and Europe as well as ALUNBRIG in Europe. Important label expansions for ADCETRIS to include previously untreated Hodgkin lymphoma approved in Japan and Europe, as well as TRINTELLIX in the U.S. to include data on speed of processing and Treatment Emergent Sexual Dysfunction.
Innovative pipeline has delivered 15 New Molecular Entity clinical stage-ups since April 2018.
44 new collaborations with biotech and academia in FY2018, and announced 3 leading-edge cell-therapy partnerships.
Disposing non-core assets to generate cash and focus the business

Consolidated Free Cash Flow +4.6% to 378.1 billion yen, including 200.9 billion yen from the sale of real estate, marketable securities, and non-core businesses Techpool and Multilab.
On May 8, 2019, Takeda announced agreements to divest XIIDRA to Novartis for $3.4 billion upfront in cash and up to an additional $1.9 billion in potential milestones, and TACHOSIL to Ethicon for €358 million upfront with a long-term Manufacturing Services Agreement.6
Takeda intends to use proceeds from the disposal of non-core assets to reduce debt and accelerate deleveraging toward its target of 2.0x net debt/adjusted EBITDA in 3 to 5 years.
Christophe Weber, President and Chief Executive Officer of Takeda, commented:

"Fiscal 2018 was an important year in the history of Takeda as we completed the acquisition of Shire to create a competitive, values-based, R&D-driven global biopharmaceutical leader. I am delighted to say that throughout the year, while we have focused on planning and executing the integration, we have also maintained strong business momentum, as demonstrated by our excellent financial results.
The integration of Shire is progressing as planned, aligned with Takeda’s values and culture. We have also identified opportunities to realize greater cost synergies, and already have made progress on our divestment strategy for non-core assets.
Looking ahead, I believe we have a strong and resilient foundation for the future growth of the business. We are focused on our five key business areas of GI, Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience, and our revenue over the medium term will be driven by a balanced portfolio including 14 global brands. Our innovative pipeline is also delivering, as shown by the 15 clinical stage-ups over the past year, and we are committed to executing towards our margin expansion and deleveraging targets.
With our business area focus, R&D engine, and financial strength, Takeda is well positioned to deliver long-term value to patients and our shareholders."

1References to "Legacy Takeda" exclude Legacy Shire financials (which have been consolidated into Takeda’s results from January 8, 2019 to March 31, 2019), costs incurred by Legacy Takeda and Legacy Shire related to the acquisition, and financial impact from purchase accounting. References to "Legacy Shire" are to the businesses acquired in Takeda’s acquisition of Shire, which was completed on January 8, 2019, and to the results of those businesses before or after the completion of the acquisition, as the context requires
2Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology, and Neuroscience
3Entyvio, Gattex/Revestive, Alofisel, Vpriv, Elaprase, Natpara/Natpar, Adynovate, Takhzyro, HyQvia, Cuvitru, Gammagard Liquid/Kiovig, Albumin/Flexbumin, Ninlaro, Alunbrig
4Schreiber S, et al. J Crohns Colitis 2019;13(Supplement_1):S612–3 (abst OP34). [Oral presentation]
5Biologics Licensing Application in the U.S.; Marketing Authorization Line Extension Application in the EU
6Divestments of XIIDRA and TACHOSIL expected to close the second half of calendar year 2019, subject to customary closing conditions, including the satisfaction of legal, regulatory and, where applicable, local works council requirements.

FY2018 Consolidated Reported Results (April – March)

iAttributable to the owners of the company.
iiCore Earnings, which is not a measure presented in accordance with IFRS, represents net profit adjusted to exclude income tax expenses, our share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on intangible assets associated with products and other items that management believes are unrelated to our core operations, such as purchase accounting effects and transaction related costs.

iiiExcludes Legacy Shire financials (from January 8, 2019 to March 31, 2019), costs incurred by Legacy Takeda and Legacy Shire related to the acquisition, and financial impact from purchase accounting.
ivAttributable to the owners of the company.
vNumber of shares used for FY2018 EPS calculation: 784,477,109 shares (as of January 7, 2019, the day before the completion of the Shire acquisition)
viCore Earnings is not a measure presented in accordance with IFRS and represents net profit adjusted to exclude income tax expenses, our share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on intangible assets associated with products and other items that management believes are unrelated to our core operations, such as purchase accounting effects and transaction related costs.

FY2019 Full Year Guidance

FY2019 Management Guidance: Business momentum expected to largely offset significant Loss of Exclusivity headwinds

Momentum of key growth products in our 5 Key Business Areas is expected to largely offset the significant Loss of Exclusivity of VELCADE, FIRAZYR, ULORIC & other products.
Full year consolidation of Legacy Shire results, cost synergies and OPEX discipline is expected to contribute to underlying Core EPS of 350-370 yen.

Guidance
Underlying Revenue Growthvii Flat to slightly declining
Underlying Core Earnings Margin Mid-twenties %
Underlying Core EPS 350-370 yen
Annual dividend per share 180 yen
Financial assumption for VELCADE in the U.S. is for one additional non-therapeutically equivalent competitor with intravenous and subcutaneous administration launching in July 2019. If no additional competitor launches, pro-forma underlying revenue growth would be "flat to slightly increasing".
vii Constant Exchange Rate growth (applying FY2018 full year average foreign exchange rate) compared to baseline of JPY 3,300 billion (pro-forma April 2018-March 2019 combined revenue of Legacy Takeda and Legacy Shire, converted at April 2018-March 2019 average exchange rate of 111 JPY/USD)

Note: FY2019 Management Guidance does not take into consideration the recently announced divestitures of XIIDRA and TACHOSIL. However, Takeda does not expect these divestitures to have a meaningful impact on its management guidance.
Costa Saroukos, Chief Financial Officer of Takeda, stated:

"Our guidance for fiscal year 2019 reflects a significant impact from Loss of Exclusivity, without which the top-line would be growing by ~6-7 percentage points, driven by continued volume expansion of key products such as ENTYVIO, TAKHZYRO, NINLARO, and our Immunoglobulin franchise. We expect our Underlying Core Earnings margin to reach the mid-twenties in fiscal 2019, and we are targeting Underlying Core Earnings margin in the mid-thirties in the medium term, driven by continued Opex efficiencies and relentless execution against our cost synergy targets. After closing the Shire acquisition we conducted a deep-dive, bottoms-up review of the synergy opportunities, and I am pleased to say we are raising our cost synergy target from $1.4 billion to approximately $2 billion in annual recurring savings by the end of fiscal 2021.
In addition to margin improvement, we also are committed to rapid deleveraging towards our target net debt / adjusted EBITDA ratio of 2.0x in 3 to 5 years. This will be driven by strong cash flow, and accelerated deleverage from our divestitures such as the recently announced agreements to sell XIIDRA and TACHOSIL. In addition, we will continue to make focused investments in the business to support our growth drivers, and intend to maintain our well-established dividend policy of 180 yen per share annually.
Takeda has delivered against its commitments in FY2018, as exemplified in our superb margin improvement and cash generation, and we are committed to delivering against our future targets to drive significant returns for our shareholders."

FY2019 Forecast: Expecting strong increase in core earnings of +92.2%, with Net Profit excluding deal-related costs and the impact of purchase accounting growing at +17.7%

Anticipate Revenue up +57.4% vs. prior year due to inclusion of Legacy Shire’s full year results for the full year.
Expect Operating Profit and EPS to be significantly impacted by Shire acquisition-related integration costs and costs related to purchase accounting. Excluding the impact of Shire acquisition-related costs and purchase accounting, Net Profit for the year would increase +17.7% (refer to the attached appendix for details).
Anticipate Core Earnings strongly increasing +92.2% from full year Legacy Shire contribution, cost synergies and continued OPEX discipline.

For more details on Takeda’s FY2018 results and other financial information, please visit View Source

On May 13, 2019, PureTech Health plc (LSE:PRTC) ("PureTech Health"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to announce that its affiliate Vedanta Biosciences reported an $18.5 million extension of its Series C financing round, bringing the total for the round to $45.5 million. (Press release, , MAY 13, 2019, View Source [SID1234574083]). The new investment comes from JSR Corporation, Shumway Capital, SymBiosis LLC, and Partners Investment Co., Ltd. These new investors join previously announced participants of the round which included the Bill & Melinda Gates Foundation, Bristol-Myers Squibb, Rock Springs Capital, Invesco Asset Management, Health for Life (Seventure Partners), and founder PureTech Health. As previously announced, the proceeds from the financing will be used to advance Vedanta’s broad clinical portfolio in indications including food allergy, advanced or metastatic cancers, and infection. A clinical study is also being advanced with Janssen as part of an ongoing collaboration in inflammatory bowel disease.

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Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech Health, said: "Expanding an already impressive syndicate with these additional investors is a tribute to Vedanta’s differentiated clinical pipeline and platform which represent a new frontier for immune-mediated diseases."

On May 13, 2019 Diamedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, reported its financial results for the three months ended March 31, 2019 (Press release, DiaMedica, MAY 13, 2019, View Source [SID1234536220]).

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Clinical Developments

DM199 for the Treatment of Chronic Kidney Disease

Phase Ib Clinical Study in Patients with CKD Nearing Full Enrollment

As previously announced, DiaMedica initiated a Phase Ib clinical trial of DM199 in patients with moderate or severe Chronic Kidney Disease ("CKD") caused by Type I or Type II diabetes mellitus. Enrollment of patients in this Phase Ib study began in February 2019 at three U.S. sites and the Company anticipates dosing the last patients in the coming weeks. Enrollment to-date has progressed slightly ahead of the original plan and the Company expects to report top-line clinical results in June 2019. "We are pleased with the safety and tolerability of DM199 observed thus far in this trial, which included three dosage levels up to 8 µg/kg," commented Harry Alcorn, DiaMedica’s Chief Medical Officer. "The lack of any significant adverse events is consistent with prior studies and gives us confidence as we prepare for our upcoming Phase II CKD studies."

The Phase Ib CKD study is an open label clinical trial evaluating three dose levels of DM199, administered in a single subcutaneous ("SC") dose, in 32 patients with moderate or severe CKD. Endpoints include safety, tolerability, pharmacokinetics, change in KLK1 levels, pharmacodynamics and biomarkers of kidney function measured over a 12-day period. This study is intended to evaluate the safety and tolerability of DM199 in CKD patients and assist in identifying dose levels for use in subsequent Phase II trials.

The Company continues to plan its Phase II study in patients with CKD caused by rare underlying diseases. This study is anticipated to start in the second half of 2019. The Company expects to provide updates on the targeted rare form diseases that will be studied in Phase II and other details in May or June 2019.

DM199 for the Treatment of Acute Ischemic Stroke

DM199 Acute Ischemic Stroke Phase II "REMEDY" Trial Update.

As previously disclosed, targeted enrollment for the REMEDY trial was increased from 60 to approximately 100 patients in order to provide additional data to support the design of a robust and efficient Phase III study. Enrollment is continuing at 12 sites and the Company expects to complete this trial in the fourth quarter of 2019 or first quarter of 2020.

In the REMEDY trial, study drug (DM199 or placebo) is administered as an intravenous ("IV") infusion within 24 hours of stroke symptom onset, followed by SC injections later that day and once every 3 days for 21 days (8 SC doses). Multiple plasma-based biomarkers (e.g. C-reactive protein), the Modified Rankin Scale, National Institutes of Health Stroke Scale and the Barthel Index are assessed at multiple points throughout the study, including 90 days post-stroke. This study also includes additional tests to further investigate DM199’s therapeutic potential.

"We are very pleased with the enrollment in our REMEDY Phase II study and our Phase Ib study in CKD patients and building upon the results of the CKD study, we plan to provide an update shortly on the targeted rare form diseases that we will study in Phase II." stated Rick Pauls, DiaMedica’s President and CEO. "We also wish to thank the study sites, physician investigators and patients for their support in advancing the study of DM199 for patients suffering from chronic kidney disease and acute ischemic stroke."

Completion of New cGMP Manufacturing Run for DM199

DiaMedica has completed a new 250 liter cGMP manufacturing run of DM199 active pharmaceutical ingredient, or drug substance. This manufacturing run follows previous manufacturing runs of 100 and 200 liters. The successful completion of this run further demonstrates DiaMedica’s technical abilities to consistently generate large quantities of high quality DM199 drug substance rapidly and efficiently to meet the needs of the development program and eventually the marketplace.

Financial Results

Research and development expenses were $2.6 million for the three months ended March 31, 2019, an increase of $1.8 million, or 230%, from $791,000 for the three months ended March 31, 2018. This increase was due to costs incurred of approximately $1.0 million related to the initiation of a new production run of the DM199 drug substance, as well as costs incurred in conjunction with the Phase Ib clinical study in CKD patients and increased year over year costs for the REMEDY Phase II stroke study. Increased personnel costs also contributed slightly to the increase.

General and administrative expenses were $814,000 for the three months ended March 31, 2019, an increase of $299,000, or 63.3%, from $515,000 for the three months ended March 31, 2018. This increase was primarily due to increased costs associated with the Company’s status as a Nasdaq-listed U.S. public reporting company, which commenced in December 2018. Increased personnel costs also contributed to the increase.

Total other income decreased 72.9% to $178,000 for the three months ended March 31, 2019 down from $657,000 for three months ended March 31, 2018. The decrease is primarily related to the initial recognition of R&D incentives from the Australian Government, paid for qualifying research work performed by DiaMedica Australia, during the three months ended March 31, 2018. This decrease was partially offset by increased interest income earned on marketable securities during the three months ended March 31, 2019.

Balance Sheet and Cash Flow

The Company had cash and cash equivalents of $2.8 million, marketable securities of $11.0 million, current liabilities of $1.4 million and working capital of $13.5 million as of March 31, 2019, compared to $16.8 million in cash and cash equivalents, $1.3 million in current liabilities and $16.7 million in working capital as of December 31, 2018. The decreases in combined cash and cash equivalents and marketable securities and in working capital are due primarily to the Company’s operating loss incurred for the three months ended March 31, 2019.

Net cash used in operating activities was $3.1 million for the three months ended March 31, 2019, compared to $935,000 for the three months ended March 31, 2018. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by non-cash charges for stock-based compensation and the net effects of changes in operating assets and liabilities.

Conference Call Information

DiaMedica management will host a conference call to discuss these results on Tuesday, May 14, 2019, at 7:00 a.m. Central Time:

Date:

Tuesday, May 14, 2019

Time:

7:00 AM CT

Web access:

View Source

Dial In:

(866) 962-3583 (domestic)

(630) 652-5857 (international)

Conference ID:

8177137

Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica’s website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until May 21, 2019, by dialing 1(855) 859-2056 (US Toll Free Dial In), (404) 537-3406 (international), replay passcode 8177137.

About DM199

DM199 is a recombinant (synthetic) form of the human serine protease, KLK1. The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostacyclin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease.

On May 13, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company, using a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, reported that it has entered into a second definitive purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park") an existing institutional investor, in which Lincoln Park has agreed to purchase in a registered direct offering 196,104 shares of common stock for $3.275 per share and pre-funded warrants at a purchase price of $3.275 per pre-funded warrant, a premium to the closing sale price on May 10, 2019 on the Nasdaq Capital Market (Press release, Trovagene, MAY 13, 2019, View Source [SID1234536237]). In a concurrent private placement, Lincoln Park has agreed to purchase warrants to purchase 458,015 shares of common stock. The pre-funded warrants sold in the registered direct offering will be exercisable immediately following the date of issuance, will expire on the fifth anniversary of the initial exercise date and have an exercise price of $0.01 per share. The warrants sold in the concurrent private placement will be exercisable six months following the date of issuance, will expire on the five and a half anniversary of the initial exercise date and have an exercise price of $3.15 per share.

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Trovagene intends to use the net proceeds from the registered direct offering and concurrent private placement as working capital to continue advancing its onvansertib clinical development programs.

Trovagene believes that the net proceeds from this investment, along with the $1.5 million investment by Lincoln Park Capital in April, will contribute to funding of the Company’s operations and costs associated with its three active open-label trials – Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC) and metastatic Colorectal Cancer (mCRC).

"We are pleased to receive this additional investment from Lincoln Park," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "Lincoln Park is a long-standing investor in the company and we appreciate their financial commitment, which is helping us to continue advancing the clinical development of our drug, onvansertib, and achieve our goal of bringing much-needed new treatment options to patients with various types of cancers."

Lincoln Park Capital, a long-only investor, has represented and warranted that with respect to securities of Trovagene they have not, and will not engage in any shorting or hedging activity prior to, or at any time after, the date hereof.

The common stock and pre-funded warrants described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-211705), previously filed with the Securities and Exchange Commission ("SEC") on May 27, 2016 and declared effective on June 13, 2016. Such shares of common stock and pre-funded warrants are being offered only by means of a prospectus supplement. A prospectus supplement and the accompanying prospectus relating to the registered direct offerings may be obtained, when available, on the SEC’s website at View Source or by contacting Trovagene, Inc.

The private placement warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the private placement warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.