Macular degeneration biotech Kodiak Sciences files for a $100 million IPO

Kodiak Sciences, a Phase 1 biotech developing antibody therapies to treat age-related macular degeneration, filed on Friday with the SEC to raise up to $100 million in an initial public offering.

The Palo Alto, CA-based company was founded in 2009 and plans to list on the Nasdaq under the symbol KOD. Kodiak Sciences filed confidentially on February 14, 2018. Morgan Stanley and BofA Merrill Lynch are the joint bookrunners on the deal. No pricing terms were disclosed.

The article Macular degeneration biotech Kodiak Sciences files for a $100 million IPO originally appeared on IPO investment manager Renaissance Capital’s web site renaissancecapital.com.

Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital’s research analysts and do not constitute an offer to buy or sell any security. Renaissance Capital’s Renaissance IPO ETF (symbol: IPO) , Renaissance International ETF (symbol: IPOS) , or separately managed institutional accounts may have investments in securities of companies mentioned.

https://www.nasdaq.com/article/macular-degeneration-biotech-kodiak-sciences-files-for-a-100-million-ipo-cm1019720

Pediatric cancer biotech Y-mAbs Therapeutics sets terms for $80M IPO

Y-mAbs Therapeutics, a phase 2 biotech developing monoclonal antibody therapies for pediatric cancers, announced terms for its IPO on Friday.

The New York, NY-based company plans to raise $80 million by offering 5.33 million shares at a price range of $14 to $16. Insiders intend to purchase $30 million worth of shares in the offering (40% of the deal). At the midpoint of the proposed range, Y-mAbs Therapeutics would command a fully diluted market value of $518 million.

Y-mAbs Therapeutics was founded in 2015 and plans to list on the Nasdaq under the symbol YMAB. BofA Merrill Lynch and Cowen are the joint bookrunners on the deal. It is expected to price during the week of September 17, 2018.

Relevant Profile: YMAB

https://www.renaissancecapital.com/IPO-Center/News/59640/Pediatric-cancer-biotech-Y-mAbs-Therapeutics-sets-terms-for-$80-million-IPO

Government work has been going out of style

While overall U.S. nonfarm payroll employment went up by 201,000 in August, according to today’s jobs report from the Bureau of Labor Statistics, government employment fell by 3,000, to 22.3 million. That put government’s share of employment at 14.97 percent, the lowest it’s been since 1957.

This does not include uniformed military. If it did, the drop since the mid-1970s would be even more pronounced, given that there were 2.1 million military personnel on active duty in 1975 and just 1.3 million as of this June.

Federal government employment, it turns out, has been shrinking as a share of total employment since 1952. State and local governments kept adding workers at a faster pace than the economy as a whole through the mid-1970s, and their shares of total employment held relatively steady for decades after that, but they have dropped over the past couple of years to levels last seen in the mid- to late 1960s (this chart starts in 1955 because that’s how far back the state and local data series go).

What is the significance of all this? I wrote a column two years ago on declining government employment that was headlined “Big Government Keeps Getting Smaller,” and I heard from a lot of readers who thought that interpretation was nonsense because (1) there are other ways in which government can be big (spending, regulatory reach) than just head count, and (2) that head count doesn’t include government contractors. It still doesn’t, because the BLS doesn’t sort employment that way. New York University public service professor Paul Light did make some estimates of government contract and grant employment in a report published last September, and they showed it going from 4.9 million (2.4 times the official civilian federal workforce) in 1984 to 7.2 million (3.4 times) in 2010 before dropping back to 5.3 million (2.6 times) in 2015. So that doesn’t change the picture that government’s share of total employment has dropped since the 1980s, and it indicates an even sharper overall drop over the course of the current economic expansion than the BLS numbers show.

Early in this expansion, the contraction of government employment was not exactly great for economic growth, as state and local governments shed 255,000 jobs in 2010 and 278,000 in 2011 (federal employment held relatively steady). More recently, though, the decline in government’s share of total employment has been mostly a sign of the health of the private sector.

As for the longer-run decline in government employment, I can think of a couple of things to say about that. One is that it might also be mainly a sign of the health of the private sector and the U.S. economy as a whole. But having just written about how government investment in infrastructure, research and development, and other things is now lower as a share of gross domestic product than at any time since the 1940s, I do wonder at least a little whether we’re reaching a point where key tasks that the private sector isn’t great at performing are being neglected. Here, for example, is the breakdown of state and local government employment between education and all other functions:

Employment at public schools and colleges peaked in 2010, long after the rest of government employment did. Which makes sense, given that public school and college enrollment had kept rising from 32.1 million in 1955 to 52.9 million in 1975 to an all-time high of 68.2 million in 2011, according to the Census Bureau. Since then, enrollment has dropped as the biggest age cohorts of the giant millennial generation have entered their late 20s (a similar demographic falloff occurred in the late 1970s). It’s down 2.1 percent since 2011, while state and local government education employment is down 0.8 percent from its peak in 2008. So … no clear evidence of undue neglect there.

The government jobs numbers may, however, help explain a political landscape in which government workers have been losing clout. President Donald Trump’s announcement last week that he was canceling a planned 2019 pay hike for federal civilian employees may matter in a few congressional districts, but nationwide, there just aren’t enough federal workers to have much election impact. And state and local government workers’ shrinking share of overall employment has probably been a factor in such defeats as Wisconsin’s 2011 legislation limiting collective bargaining for most public employees.

https://www.bloomberg.com/view/articles/2018-09-07/jobs-report-government-work-has-been-going-out-of-style

Facial plastic surgeons call for reduction of opioid prescriptions after rhinoplasty

A team of surgeons at Massachusetts Eye and Ear found that, of 173 patients undergoing rhinoplasty, a common procedure performed in the facial plastic and reconstructive surgery field, only two refilled their opioid prescriptions after the procedure — with some patients not filling their initial opioid prescription at all. Published online today in JAMA Facial Plastic Surgery, these results suggest that patients experienced less pain than expected, and that the optimal number of opioid tablets to manage postoperative rhinoplasty pain may be lower than expected.

“When we looked at the number of patients who needed refills, we found this near-negligible number,” said corresponding author David A. Shaye, MD, MPH, a facial plastic and reconstructive surgeon at Mass. Eye and Ear and an instructor in otolaryngology at Harvard Medical School. “This tells us that, as a field, we’re probably overprescribing in rhinoplasty.”

The team reviewed 173 rhinoplasty cases performed at Mass. Eye and Ear over a one-year period. Of the 173 patients, 168 were prescribed opioids in addition to acetaminophen, at an average of 28 pills per patient. Refills were found to be extremely rare, with only two patients refilling, and with some patients (11.3 percent) not filling their initial opioid prescription at all. The team confirmed the refill rate by querying the Massachusetts State Registry.

“After analyzing our data, we were pleasantly surprised by the lack of opioids patients actually required after rhinoplasty, which is especially significant given the current opioid epidemic, said co-author Linda N. Lee, MD, a facial plastic and reconstructive surgeon at Mass. Eye and Ear and an instructor in otolaryngology at Harvard Medical School. “Understanding this data, we as surgeons have a duty to responsibly prescribe opioids and limit the potential for abuse, particularly for cosmetic or elective surgeries.”

A reduction in narcotic prescriptions after rhinoplasty may limit the opportunity for opioid abuse — an epidemic in the United States, where less than five percent of the world’s population consumes two-thirds of the world’s opioid supply. Opioid-related deaths have increased by 200 percent since 2000. Studies show that nearly 60 percent of adults in the United States have leftover opioids in their homes.

As a result of their findings, the authors have reduced the number of opioid tablets they prescribe to patients by at least 50 percent.

In addition to Drs. Shaye and Lee, authors on the JAMA Facial Plastic Surgery letter include Rosh K. V. Sethi, MD, Olivia E. Quatela and Kayla G. Richburg, of Massachusetts Eye and Ear/Harvard Medical School.

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Story Source:

Materials provided by Massachusetts Eye and Ear Infirmary. Note: Content may be edited for style and length.

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Journal Reference:

1. Sethi RKV, Lee LN, Quatela OE, Richburg KG, Shaye DA. Opioid Prescription Patterns After Rhinoplasty. JAMA Facial Plastic Surgery, 2018; DOI: 10.1001/jamafacial.2018.0999

https://www.sciencedaily.com/releases/2018/09/180906141608.htm

Philips: Validation of instant wave-free ratio (iFR) technology continues to grow

Philips is a leading innovator in image-guided therapies for cardiovascular diseases, as well as other diseases. The company has invested significantly in this important area in healthcare, as it offers strong benefits for both patients and health systems.

Last week, the European Society of Cardiology announced that it had incorporated iFR into its updated revascularization guidelines. This is a very important step in the validation of instant wave-free ratio (iFR) technology.

Unique to Philips, iFR is an innovative pressure-derived index a technology that’s used to assess coronary blockages in patients with ischemic heart disease (IHD), helping to identify the appropriate therapy for each patient. The technology offers a procedure that provides functional measurement while reducing patient discomfort by 90 percent, reducing costs by approximately 10 percent per patient over a one-year average and reducing time spent in the lab by 10 percent.

Diagnostic and Interventional Cardiology recently published an interesting feature giving an overview of the latest developments in this field, including the validation of iFR. You can read the full article here.

https://www.marketscreener.com/ROYAL-PHILIPS-6289/news/Royal-Philips-Validation-of-iFR-technology-continues-to-grow-27227724/

A.M. Best Affirms Credit Ratings of Anthem, Inc. and Its Subsidiaries

A.M. Best has affirmed the Financial Strength Rating (FSR) of A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a+” of the core Blue Cross Blue Shield-branded insurance subsidiaries of Anthem, Inc. (Anthem) (Indianapolis, IN) [NYSE:ANTM]. The outlook of these Credit Ratings (ratings) is stable.

Concurrently, A.M. Best has affirmed the Long-Term ICR of “bbb+”, the Long- and Short-Term Issue Credit Ratings (Long-Term IR; Short-Term IR) of Anthem and the Long-Term IR on the existing surplus notes of Anthem Insurance Companies, Inc. (Indianapolis, IN). The outlook of these ratings is stable.

Furthermore, A.M. Best has affirmed the FSR of A- (Excellent) and the Long-Term ICRs of “a-” of the UNICARE, AMERIGROUP and the CareMore companies. The outlook of these ratings is stable. (See link below for a detailed listing of the companies and ratings.)

The Blue Cross Blue Shield-branded entities, also referred to as Anthem Health Group (Anthem Health), are part of the core subsidiaries of Anthem.

The ratings reflect Anthem Health’s balance sheet strength, which A.M. Best categorizes as very strong, as well as its strong operating performance, favorable business profile and appropriate enterprise risk management (ERM).

Anthem Health’s risk-adjusted capitalization is viewed as strongest, as measured by Best’s Capital Adequacy Ratio (BCAR). Anthem Health is the main source of earnings for its parent organization, with dividends exceeding $2 billion in four of the past five years, and just under $2 billion in 2017. Anthem Health has consistently reported strong underwriting and net income over the past five years, and produced very favorable results across its diverse set of business lines and in its various core markets. The group has good geographic diversity, as Anthem operates Blue Cross Blue Shield plans in 14 states with strong brand name recognition and leading market share in the majority of these states. Additionally, the Anthem companies have a strong presence in the national account/BlueCard market segment. Nevertheless, there is geographic limitation to its business based on the Blue Cross/Blue Shield licenses.

Anthem Health’s ERM is managed at the ultimate parent, Anthem, level, but it has local functionality as well. Anthem has a well-established ERM program that is coordinated at the corporate level. Anthem’s ERM is considered appropriate for its risk profile, and the company has a mature developed ERM program. Risk identification and reporting are completed on a regular basis, and ERM is incorporated into the corporate strategic planning. There is established oversight and monitoring of the ERM program.

Anthem has strong diversified earnings and revenues through its Blue Cross Blue Shield-branded entities in 14 states, as well as its non-Blue branded with CareMore, AMERIGROUP and UNICARE entities. Financial leverage at Anthem rose to just above 40% due to a combination of its November 2017 and early 2018 issuances; however, financial leverage is expected to moderate throughout 2018. This is expected to occur through a combination of the elimination of existing debt and increases in equity driven by retained earnings. Earnings before interest and taxes interest coverage was adequate at 6.2 times for 2017 but is lower than its peers. Additionally, the holding company maintains good liquidity with access to a $3.5 billion revolving-credit facility, a $2.5 billion commercial paper program, and certain of its insurance subsidiaries are members of the Federal Home Loan Bank of Indianapolis with the ability to borrow funds if needed. While Anthem’s goodwill plus intangibles to equity is considered high at over 100%, it is similar to some of its peers. Furthermore, A.M. Best acknowledges that a portion of the intangibles is the Blue Cross/Blue Shield trademarks, which are required to operate as a Blue Cross Blue Shield-branded entity.

https://www.marketscreener.com/ANTHEM-INC-18740543/news/A-M-Best-Affirms-Credit-Ratings-of-Anthem-Inc-and-Its-Subsidiaries-27227994/

Spectrum-Hanmi partnership to offer new treatment paradigm for lung cancer

South Koreas Hanmi Pharmaceutical said Thursday that its global partner Spectrum Pharmaceuticals will be announcing the results of phase 2 clinical trials for poziotinib, a lung cancer treatment currently under development, at the IASLC 19th World Conference on Lung Cancer.

Spectrum Pharmaceuticals plans to present the results of phase 2 non-small cell lung cancer study using poziotinib, which includes, for the first time, data on the drugs efficacy for patients with EGFR and HER2 exon 20 mutations.

Among the 40 out of 50 patients in the EGFR cohort with analysis-ready data, poziotinib showed a robust efficacy with an objective response rate of 58 percent. The median progression-free survival period was 5.6 months, while the disease control rate was 90 percent.

In the HER2 cohort, the objective response rate was 50 percent, while the disease control rate was 83 percent, according to Spectrum Pharmaceuticals.

The most common side effects were skin rash (27.5 percent), diarrhea (12.5 percent) and paronychia (7.5 percent). Around 45 percent of the patients involved in the study required a dose reduction to 12 milligrams, while 17.5 percent required a dose reduction to 8 mg.

Spectrum Pharmaceuticals said it plans to share updated data on the study during an oral presentation at the lung cancer academic conference in Toronto, Canada, on Sept. 24.

We expect poziotinib to present a new treatment paradigm to patients which havent been responding to existing treatments. We will work hard to commercialize the drug to bring hope to patients suffering from cancer, said Hanmi Pharmaceutical CEO Kwon Se-chang in a statement.

Looking ahead, Spectrum Pharmaceuticals said it is working to expand the poziotinib clinical program to explore the drugs efficacy in a number of new areas, including first-line treatment of NSCLC, treatment of other solid tumors with EGFR or HER2 mutations, as well as other combination therapies.

https://www.marketscreener.com/SPECTRUM-PHARMACEUTICALS-10921/news/Spectrum-Pharmaceuticals-Hanmi-says-poziotinib-to-offer-new-treatment-paradigm-for-lung-cancer-27227551/