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Thursday, December 13, 2018

‘Insanity’ May Be the Muni-Bond Market’s Next Big Thing


It’s a “considerable risk,” a “bad idea,” or, as one expert put it, “insanity.” And it may be the next big pitch Wall Street bond underwriters make to states and cities desperate to cover ballooning health-care costs.
Dearborn, Michigan, the 94,000-resident city that’s home to Ford Motor Co., tested the waters this week by selling $35 million of bonds to chip away at the $161 million it needs to cover the medical bills of workers who will retire in the years ahead. The city is betting that by investing the proceeds it will earn more than it will pay in interest, with the profits helping to cover health-care expenses.
Many states and cities have used the same strategy for their pensions, and Chicago Mayor Rahm Emanuel Wednesday proposed a $10 billion debt sale for the city’s ailing retirement system. Some have came out ahead. Others were burned by stock market losses or because the temporary boost allowed governments to cut their annual pension payments. Illinois, New Jersey and Puerto Rico borrowed billions only to see the large shortfalls reappear.
The tactic has been used far less for health-care costs, but it isn’t unprecedented. Over a decade ago, five Wisconsin school districts plowed borrowed funds into collateralized debt obligations, the toxic investments that blew up after the housing market crash, with the intent of spending the earnings on health care. They lost the money instead.
“These are expenses that should be paid for out of the budget — not bonded out,” said Thad Calabrese, an associate professor at New York University who studies public financial management and called such deals “insanity.” “It’s surprising it hasn’t been done more and I’m thankful it hasn’t.”
Governments are eager for ways to cover the health benefits that they’ve promised retirees, which, unlike pensions, are usually funded out of their annual budgets on a pay-as-you-go basis. S&P Global Ratings said the costs are a “growing” concern, with states alone facing $678 billion of unfunded liabilities. New York City’s $98 billion unfunded liability for retiree health care is bigger than its bond debt and its pension-fund shortfall.
The Government Finance Officers Association recommends against selling bonds to finance those medical costs, citing the “considerable risk.” That’s because there’s a chance they will earn less than it cost to borrow, leaving them deeper in the hole, which has been the case with governments that sold pension bonds just before stock market routs.
Wixom, Michigan, also turned to the bond market this year to address legacy costs with retiree health care. Such a step has been allowed by Michigan lawmakers, who are considering a bill that would extend this year’s deadline for localities to sell bonds to pay off health and pension liabilities until 2023.
Dearborn paid yields of 4.6 percent or less on the bonds it issued this week, well below the 7 percent or more that pension funds typically expect to earn each year on their investments. The injection of cash will bolster a health-care plan that was already about 29 percent funded as of fiscal 2016, bond documents say. That’s higher than the statewide average for localities that offer such benefits, James O’Connor, director of finance and treasurer for the city, said in an email.
“Unlike most municipalities in the state, the city of Dearborn has been prefunding its OPEB Trust Fund for some time,” he said. The bond sale is part of an effort to reduce the liability that includes closing the plan to new hires, he said.
Municipal Market Analytics said in a report this month that it’s possible that more cities could follow Dearborn, in part because Wall Street underwriters will be looking for ways to drum up business given the lackluster pace of bond sales.
But the company said that — like pension bonds — they’re “a bad idea, maybe worse.”

Guardant Health, AstraZeneca partner to develop companion diagnostics tests


Guardant Health (GH) announced a multi-year agreement with AstraZeneca (AZN) to develop blood-based companion diagnostic tests supporting the commercialization of AstraZeneca’s oncology portfolio based on Guardant’s industry-leading comprehensive liquid biopsy platform.Under the terms of the agreement, Guardant Health will develop and pursue FDA approval for a Guardant360 CDx test for Tagrisso, AstraZeneca’s best-in-class, third-generation EGFR inhibitor in advanced non small cell lung cancer. Use of this assay will help identify patients that may respond to Tagrisso via a minimally-invasive blood test.Guardant Health will also develop a plasma-based tumor mutational burden score CDx test using GuardantOMNI to predict response to AstraZeneca immunotherapy and targeted therapies within its oncology portfolio. AstraZeneca presented TMB data using this device from the Phase III MYSTIC trial at the European Society for Medical Oncology Immuno-Oncology 2018 Congress. The US Food and Drug Administration has granted breakthrough designation to the GuardantOMNI diagnostic device for its proprietary plasma-based TMB score. The Guardant TMB scoring methodology is optimized for plasma-based testing by accounting for several factors, including tumor shedding, to maximize sensitivity and specificity. The agreement allows for development of further liquid biopsy CDx tests for AstraZeneca’s other clinical development programs.
https://thefly.com/landingPageNews.php?id=2836857

Pacira: Less Postsurgical Pain, Opioid Requirements with EXPAREL


Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the publication of new data from a retrospective investigator-initiated study analyzing the use of EXPAREL (bupivacaine liposome injectable suspension) administered as a transversus abdominis plane (TAP) block to manage postsurgical pain following cesarean section (C-section) procedures.
Findings show that patients receiving EXPAREL had a significant reduction in opioid consumption and pain intensity, as well as significantly improved discharge- and postanesthesia care unit (PACU)-ready times, functional recovery and reduced length of stay (LOS). The study results were published this week in The Journal of Pain Research.
Study researchers reviewed the charts of 201 consecutive women who underwent C-section procedures and received a multimodal pain management protocol with or without a TAP block utilizing 266 mg of EXPAREL. The study population included patients who underwent elective, unscheduled waiting list, or emergency cesarean delivery with anesthesia and post-cesarean pain management by one anesthesiologist at Texas Children’s Hospital Pavilion for Women between 2012 and 2015.
Compared to patients who received multimodal pain control without the use of EXPAREL, patients who received a TAP block demonstrated a statistically significant: Decrease in postsurgical opioid consumption by 47%.

Danaher Initiates 2019 Outlook


Ahead of its annual investor and analyst meeting to be held in New York CityDanaher Corporation (NYSE: DHR) (the “Company”) initiated its 2019 outlook. The Company anticipates that 2019 diluted net earnings per share will be in the range of $4.02 to $4.12.
2019 non-GAAP adjusted diluted net earnings per share is anticipated to be in the range of $4.75 to $4.85, which assumes non-GAAP core revenue growth of approximately 4%.
Thomas P. Joyce, Jr., President and Chief Executive Officer, stated, “We are very pleased with our 2018 performance year-to-date. We delivered strong revenue growth and operating margin expansion, double-digit earnings per share growth and closed over $2B in acquisitions including IDT, a leading player in the genomics consumables market. We believe this year’s solid cash flow performance — in addition to our exceptional balance sheet capacity — positions us very well for future strategic capital deployment.”
Joyce continued, “We have transformed Danaher meaningfully over the past several years, evolving into a higher growth, higher margin, and higher recurring revenue company. We have done this through a combination of organic and inorganic growth initiatives, which have helped drive market share gains in many of our businesses. Looking ahead, with the power of the Danaher Business System as our foundation we will continue to focus on building a better, stronger Danaher and creating shareholder value for years to come.”
Danaher will host a live video webcast of its investor and analyst meeting today, December 13, 2018, beginning at 9:30 a.m. ET and concluding at approximately 12:00 p.m. ET. The video webcast will be available on the Investors section of Danaher’s website, www.danaher.com, under the heading “Events & Presentations.” A replay of the webcast will be available shortly after the conclusion of the presentation.

AMAG Pharmaceuticals Strikes Deal to Acquire Perosphere and Its Anticoagulant


Waltham, Mass.-based AMAG Pharmaceuticals, Inc. will acquire privately-held Perosphere Inc.to leverage its expertise in hematology. The deal will provide the company the rights to ciraparantag, a next-generation anticoagulant reversal agent in mid-stage development.
Perosphere’s ciraparantag is currently being investigated for helping patients who have been treated with novel oral anticoagulants (NOACs) or low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. Ciraparantag, which received Fast Track Designation from the U.S. Food and Drug Administration in 2015, is currently in Phase IIb development. Earlier this month, at the American Society of Hematology meeting in San Diego, Persophere, presented data that showed ciraparantag demonstrated a complete and sustained reversal of coagulants apixaban and rivaroxaban. In previous studies, ciraparantag had shown complete and sustained reversal of the NOAC, edoxaban, and the LMWH, enoxaparin, following a single intravenous bolus dose.

AMAG President and Chief Executive Officer William Heiden said his company has been searching for a “novel hematology asset” that will complement the company’s existing portfolio, as well as leverage the expertise of the company’s “high performing Feraheme hematology team.”
“This acquisition represents a great strategic fit and a unique opportunity to add an innovative, durable and differentiated mid-phase clinical asset to our portfolio,” Heiden added.
In AMAG’s announcement this morning about the acquisition, the company noted that ciraparantag has patent protection through 2034. The company said that NOAC therapy represents the fastest-growing segment of the anticoagulant market in the United States. AMAG noted that in the U.S., there are about 6 million patients on NOAC and LMWH therapy and about 9 million additional patients across the globe. AMAG pointed to a recent study that showed a small portion of NOAC patients, between 1.5 and 2 percent, are at risk for serious bleeding complications each year.
AMAG aims to take ciraparantag into Phase III development. Julie Krop, AMAG’s chief medical officer, said the company is excited about adding ciraparantag to its portfolio. Krop said the company believes ciraparantag has the potential to “positively impact patient care in this rapidly growing patient population.” The Phase III program will be partially funded by an unnamed pharmaceutical company that does not have commercialization rights for ciraparantag due to an existing agreement, AMAG said.
Under terms of the deal for Perosphere, AMAG will pay $50 million upfront and will also assume 12 million under a term loan and up to $6.2 million of Perosphere’s other liabilities. Perosphere shareholders could see an additional $140 million in regulatory milestone payments, although that could lessen if ciraparantag is approved with a boxed warning. That $140 million is inclusive of a $40 million milestone payment upon approval by the European Medicines Agency, AMAG noted. If ciraparantag is approved, AMAG said that Perosphere shareholders are eligible to receive up to an aggregate of $225 million in commercial sales milestones. The first commercial milestone payment of $20 million would be payable upon achieving annual net sales of $100 million
The deal is expected to be finalized in the first quarter of 2019.

Kezar presents at BMO conference

Kezar Life Sciences, Inc. (KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, today announced that John Fowler, Chief Executive Officer, will present at The BMO Prescriptions for Success Healthcare Conference on December 12, 2018, at 10:00 am EST.
The presentation will be webcast and may be accessed at the “Events & Presentations” section of the Company’s website at http://investors.kezarlifesciences.com/events. Kezar Life Sciences will maintain an archived replay of the webcast on its website for 30 days after the conference.
https://finance.yahoo.com/news/kezar-life-sciences-present-bmo-130000372.html

Esperion initiated at Goldman Sachs


Esperion initiated with a Sell at Goldman Sachs. Goldman Sachs analyst Paul Choi started Esperion Therapeutics with a Sell rating and $45 price target.