Wednesday, November 1, 2017

Citius Pharmaceuticals, Inc. Receives "Fast Track" Designation By FDA For Mino-Lok™ Investigational Trial





Source:  Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received official notice from the U. S. Food and Drug Administration ("FDA") that the investigational program for Mino-Lok™ is designated "Fast Track".  Mino-Lok is a catheter lock solution that has entered phase 3 trials for an adjunctive treatment for catheter related blood stream infection ("CRBSI"). Fast Track is a designation by the FDA of an investigational drug to expedite review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.


A drug that receives Fast Track designation is eligible for the following:
  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
  • More frequent written correspondence from FDA about the design of the clinical trials;
  • Priority review to shorten the FDA review process for a new drug from ten months to six months; and,
  • Rolling Review, which means Citius can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
There are currently no approved therapies to salvage infected central venous catheters ("CVCs"), a potential $750 million sector in the US alone.  CRBSIs are responsible for mortality rates up to 25% in some patients, and contribute to significant morbidities. Citius is currently starting up sites for a phase 3 trial of Mino-Lok in the United States.
Mr. Myron Holubiak, Chief Executive Officer of Citius, commented "We are extremely pleased to receive Fast Track designation from the FDA. The agency has been very supportive and helpful in developing the trial design for Mino-Lok as salvage therapy for infected CVCs in CRBSI.  We look forward to our continuing collaboration in developing Mino-Lok."

About Citius Pharmaceuticals, Inc.
Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.

Citius Pharmaceuticals Issues Shareholder Letter





Source:  Citius Pharmaceuticals, Inc.

Company Highlights Recent Nasdaq Uplisting and Additional Operational Milestones

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that the Company mailed a letter to its shareholders updating them on recent developments, financial results, and new business opportunities. Highlights include:

  • Successfully uplisted to Nasdaq stock exchange where the company will gain access to broader investor audience.
  • Received positive response from the U.S. Food and Drug Administration (FDA) for phase 3 trial amendments of Mino-Lok™, our proprietary product that address a potential $750 million sector.
  • Secured funding of more than $26.8 million, including a recent raise of $6.8 million, with significant insider participation.
  • Finalized the addition of South America to The Company's worldwide license for Mino-Lok™.
  • Completed Phase 2a studies for Hydro-Lido, which could become the first FDA-approved product to address the estimated $500 million U.S. hemorrhoid marketplace.
"We are extremely pleased with the significant advancements that we have made and the foundation for long-term growth that we have established," stated Mr. Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.  "Having transitioned to a more senior exchange and completed key initiatives in advancing our unique technologies, we felt it necessary to provide a thorough update on the overall health and trajectory of the Company.  We are confident, now that we now well-funded, to ideally be positioned as potential market leaders in two greatly underserved therapeutic areas. Management is committed to advancing the commercialization efforts of our products, Mino-Lok™ and Hydro-Lido, while remaining focused on our goal of improving shareholder value."

About Citius Pharmaceuticals, Inc.Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.


Citius Pharmaceuticals, Inc. Provides Phase 3 Update On Mino-Lok™ Clinical Trial Following FDA Meeting






Source:  Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received feedback from the U. S. Food and Drug Administration regarding amendments to the phase 3 study plan for Mino-Lok™, an adjunctive treatment for catheter related blood stream infection. There are currently no approved therapies to salvage infected central venous catheters ("CVCs").  Citius is currently recruiting sites for a phase 3 trial of Mino-Lok in the United States.

The FDA stated that they recognized that there is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority design would address the Company's concerns and would be acceptable. They also reinforced their commitment to work with the Company to revise the trial design to meet the requirements of a new drug application.

Following the discussion with the FDA, Citius amended the phase 3 study design to remove the saline and heparin placebo control arm and to use an active control arm that conforms with today's current standard of care. The Company also noted that the dwell times and dosing schedules of the antibiotic lock therapy ("ALT") active control arm would be changed because there is an extreme level of variability and heterogeneity in how ALTs are dosed and used today.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, "We are extremely pleased to work closely with the FDA to design a trial that meets today's need for better information and evidence as it relates to the treatment of infected CVCs and dosing schedules for ALTs.  Experts agree that there is a great deal of variability allowed in the Infectious Disease Society of America (IDSA) guidelines with respect to the antibiotic chosen and the dwell times used for ALT's.  We are confident that we will be able to demonstrate the superiority of our ready-to-use Mino-Lok over hospital compounded antibiotic solutions for which there have not been any largescale controlled studies or data driven evidence."  

About Citius Pharmaceuticals, Inc.
Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.



Citius Pharmaceuticals, Inc. Prices $6,800,000 Public Offering And Listing On The Nasdaq Capital Market


Source:  Citius Pharmaceuticals, Inc.

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the pricing of an underwritten public offering of 1,648,484 shares of its common stock and warrants to purchase up to an aggregate of 1,648,484 shares of its common stock at a combined offering price of $4.125 per share. The warrants will have a per share exercise price of $4.125, are exercisable immediately and will expire five years from the date of issuance. The gross proceeds to Citius from this offering are expected to be approximately $6,800,000, before deducting underwriting discounts and commissions and other estimated offering expenses. Citius has granted the underwriters a 45-day option to purchase up to an additional 247,272 shares of common stock and/or 247,272 additional warrants to cover over-allotments, if any. The offering is expected to close on August 8, 2017, subject to customary closing conditions. Shares of our Common Stock and Warrants will begin trading on August 3, 2017 under the symbols "CTXR" and "CTXRW," respectively on the Nasdaq Capital Market.

Aegis Capital Corp. is acting as the sole book-running manager for the offering and Dawson James Securities, Inc. is acting as co-Manager for the offering.

A registration statement on Form S-1 relating to these securities has been filed with the Securities and Exchange Commission and became effective on August 2, 2017.

The offering will be made only by means of a prospectus. A copy of the prospectus relating to the offering may be obtained, when available, by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@aegiscap.com. Investors may also obtain these documents at no cost by visiting the SEC's website at http://www.sec.gov. Before you invest, you should read the prospectus and other documents the Company has filed or will file with the Securities and Exchange Commission for more complete information about the Company and the offering.

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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Citius Pharmaceuticals, Inc.Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infectives, cancer care and unique prescription products using innovative, patented or proprietary formulations of previously approved active pharmaceutical ingredients.  We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs.  By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com

Citius Pharmaceuticals Announces US Patent Office Publication Of Enhanced Stability Patent Application Covering Mino-Lok™

Source:  Citius Pharmaceuticals, Inc.

US Patent Office Has Published Patent Application for Enhanced Stability Of Antimicrobial Solutions for Locking Central Venous Catheters (CVCs)

Citius Pharmaceuticals, Inc. ("Citius") (OTC BB: CTXRD), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received notification from MD Anderson Cancer Center that US Patent Application (US 2017/0151373 A1) has been published by the US Patent Office, date of publication June 1, 2017: the application was originally filed on November 4, 2016.

The patent invention overcomes limitations in mixing antimicrobial solutions in which components may precipitate because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions. Citius holds the exclusive worldwide license  which provides access to this patented technology for development and commercialization of Mino-Lok.

"The stability of the Mino-Lok solution post mixing was limited to a time period of about 24 hours prior to use," said Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We recognized that it would be beneficial for product acceptance and utility if improvement in the post-mix stability could be achieved; this would enable standard pharmacy process to be employed in the delivery of Mino-Lok to the patient, and  would allow for several days storage of ready-to-use Mino-Lok. Aside from also offering greater intellectual property protection if the patent is granted, the post-mix stability of Mino-Lok is important to the potential world market for the product. Citius is committed to developing Mino-Lok as a cost saving therapy in all countries, as we believe Mino-Lok should find receptive markets worldwide." 

Citius is currently recruiting sites for phase 3 trials of Mino-Lok in the United States. There are currently no approved therapies to salvage infected CVCs. 

Mino-LokTM is under investigation and not approved for commercial use.

About Citius Pharmaceuticals, Inc.Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.

About MD Anderson Cancer CenterThe University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected facilities for cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI) and is ranked No.1 for cancer care in U.S. News & World Report's most recent "Best Hospital's" survey. The center has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).


Monday, May 1, 2017

Barchart.com's Chart of the Day - Aflac (From 4/29/17)


Source:  Barchart.com



Barchart.com's Chart of the Day - Aflac

For Apr 29, 2017
The Chart of the Day belongs to Aflac (AFL).  I found the health & life insurance stock by using Barchart to sort today's All Time High list first for the most frequent number of new highs in the last month, then again for technical buy signals of 80% or more.  Since the Trend Spotter signaled a buy on 2/14 the stock gained 5.41%.
AFLAC Inc. is a general business holding company and acts as a management company, overseeing the operations of its subsidiaries by providing management services and making capital available. Its primary business is supplemental health and life insurance, which is marketed and administered primarily through its subsidiary, American Family Life Assurance Company of Columbus.

The status of Barchart's Opinion trading systems are listed below. Please note that the Barchart Opinion indicators are updated live during the session every 10 minutes and can therefore change during the day as the market fluctuates. The indicator numbers shown below therefore may not match what you see live on the Barchart.com web site when you read this report.

Barchart technical indicators:
·        88% technical buy signals
·        Trend Spotter buy signal
·        Above its 20, 50 and 100 day moving averages
·        15 new highs and up 3.55% in the last month
·        Relative Strength Index 65.55%
·        Technical support level at 74.14%
·        Recently traded at 74.88 with a 50 day moving average of 72.64
Fundamental factors:
·        Market Cap $30.04 billion
·        P/E 11.14
·        Dividend yield 2.29%
·        Revenue expected to decrease slightly for the this year and the next
·        Earnings estimated to increase 4.80% next year and compound at an annual rate of 6.70% for the next 5 years
·        Wall Street analysts issued 3 strong buy, 11 hold and 1 sell recommendation on the stock
View more information for today's symbol:
Barchart's Chart of the Day is a free email newsletter providing commentary and analysis on one ticker symbol or commodities contract each trading day. In order to assure consistent delivery of the newsletter into your inbox, add newsletters@barchart.com to your Address Book For troubleshooting help on email delivery, please visit http://www.barchart.com/newsletters/whitelist.php.


Sunday, April 30, 2017

Aflac Incorporated Announces First Quarter Results, Affirms 2017 Outlook, Declares Second Quarter Cash Dividend

Source:  Aflac Incorporated

Aflac Incorporated today reported its first quarter results.

Total revenues decreased 2.6% to $5.3 billion during the first quarter of 2017, compared with $5.5 billion in the first quarter of 2016. Net earnings were $592 million, or $1.47 per diluted share, compared with $731 million, or $1.74 per share, a year ago. The decrease in revenue and net earnings reflects realized gains and losses in the comparable quarters and lower premium and investment income in the Japan segment attributable to the low-interest-rate environment.   

Net earnings in the first quarter of 2017 included pretax net losses of $129 million, or $.31 per diluted share on a pretax basis, compared with pretax net gains of $40 million, or $.09 per diluted share on a pretax basis, a year ago. Beginning in the first quarter of 2017, the company began reporting amortized hedge costs associated with certain U.S. dollar investments in the Japan portfolio as part of operating earnings. Pretax net realized losses from securities transactions and impairments for the first quarter amounted to $17 million and were composed of pretax net realized investment losses from securities transactions of $7 million, and pretax realized investment losses from impairments of $10 million. Pretax net realized investment losses from certain derivative and foreign currency activities in the quarter were $92 million. Net earnings also included a pretax loss of $20 million, reflecting guaranty fund assessments of $14 million and Japan branch conversion costs of $6 million. The income tax benefit on non-operating items in the quarter was $45 million. See the "Reconciliation of Net Earnings to Operating Earnings" schedule.

The following discussion includes references to Aflac's non-U.S. GAAP performance measures, operating earnings, operating earnings per diluted share and operating return on equity. These measures are not calculated in accordance with U.S. GAAP. The measures exclude items that the company believes may obscure the underlying fundamentals and trends in insurance operations because they tend to be driven by general economic conditions and events or related to infrequent activities not directly associated with insurance operations. Management uses operating earnings and operating earnings per diluted share to evaluate the financial performance of Aflac's insurance operations on a consolidated basis and believes that a presentation of these measures is vitally important to an understanding of the underlying profitability drivers and trends of Aflac's insurance business.

Aflac defines operating earnings (a non-U.S. GAAP financial measure) as the profits derived from operations. Operating earnings includes interest cash flows associated with notes payable and hedge costs related to foreign currency denominated investments, but excludes certain items that cannot be predicted or that are outside of management's control, such as realized investment gains and losses from securities transactions, impairments, and certain derivative and foreign currency activities; nonrecurring items; and other non-operating income (loss) from net earnings. Nonrecurring and other non-operating items consist of infrequent events and activity not associated with the normal course of the Company's insurance operations and do not reflect Aflac's underlying business performance. Operating earnings per share (basic or dilutive) are the operating earnings for the period divided by the average outstanding shares (basic or dilutive) for the period presented. Operating return on equity excluding foreign currency effect is calculated using operating earnings excluding yen, as reconciled with total U.S. GAAP net earnings, divided by average shareholders' equity, excluding accumulated other comprehensive income (AOCI). The comparable U.S. GAAP measure is return on average equity (ROE) as determined using net earnings and average total shareholders' equity. Reconciliations of the foregoing non-GAAP measures to the most comparable U.S. GAAP measures are provided in the schedules accompanying this release.

Due to the size of Aflac Japan, where the functional currency is the Japanese yen, fluctuations in the yen/dollar exchange rate can have a significant effect on reported results. In periods when the yen weakens, translating yen into dollars results in fewer dollars being reported. When the yen strengthens, translating yen into dollars results in more dollars being reported. Consequently, yen weakening has the effect of suppressing current period results in relation to the comparable prior period, while yen strengthening has the effect of magnifying current period results in relation to the comparable prior period. As a result, the company views foreign currency translation as a financial reporting issue for Aflac rather than an economic event to the company or shareholders. Because a significant portion of the company's business is conducted in Japan and foreign exchange rates are outside of management's control, Aflac believes it is important to understand the impact of translating Japanese yen into U.S. dollars. Operating earnings, operating earnings per diluted share "excluding current period foreign currency impact" and operating return on average shareholders' equity excluding foreign exchange are computed using the average yen/dollar exchange rate for the comparable prior year period, which eliminates dollar based fluctuations driven solely from currency rate changes.

The average yen/dollar exchange rate in the first quarter of 2017 was 113.56, or 1.6% stronger than the average rate of 115.35 in the first quarter of 2016. Operating earnings in the first quarter were $676 million, compared with $705 million in the first quarter of 2016. Operating earnings per diluted share decreased .6% to $1.67 in the quarter, compared with $1.68 a year ago. The stronger yen/dollar exchange rate increased operating earnings per diluted share by $.01 for the first quarter. Excluding the impact of the stronger yen, operating earnings per diluted share decreased 1.2%.
Total investments and cash at the end of March 2017 were $120.5 billion, compared with $116.4 billion at December 31, 2016.

In the first quarter, Aflac repurchased $600 million, or 8.5 million of its common shares. At the end of March, the company had 18.3 million shares available for purchase under its share repurchase authorizations.

Shareholders' equity was $20.3 billion, or $51.11 per share, at March 31, 2017, compared with $20.0 billion, or $48.22 per share, at March 31, 2016. Shareholders' equity at the end of the first quarter included a net unrealized gain on investment securities and derivatives of $4.5 billion, compared with a net unrealized gain of $4.7 billion at the end of March 2016. The annualized return on average shareholders' equity in the first quarter was 11.6%.

Shareholders' equity was $17.7 billion, or $44.49 per share (excluding AOCI) at March 31, 2017, compared with $17.1 billion, or $41.15 per share, at March 31, 2016. On an operating basis (excluding AOCI), the annualized return on average shareholders' equity for the first quarter was 15.1%, excluding the impact of foreign currency.

AFLAC JAPAN
In yen terms, Aflac Japan's premium income, net of reinsurance agreements, decreased 1.1% in the first quarter to ¥362.9 billion, with growth in third sector premium offset by reduced first sector premium. Net investment income declined 6.3%, reflecting the stronger yen/dollar exchange rate on dollar-denominated investment income, increased amortized hedge costs on the U.S. dollar investment portfolio and the persistent low-interest-rate environment. Amortized hedge costs on the U.S. dollar investment portfolio totaled $52 million in the quarter, as compared to $32 million in the previous year. Total revenues were down 1.9% to ¥427.7 billion in the first quarter. Pretax operating earnings in yen decreased 5.6% on a reported basis and 5.1% on a currency-neutral basis. The pretax operating profit margin for the Japan segment was 20.5%, compared with 21.3% in the prior year.
Aflac Japan's growth rates in dollar terms for the first quarter were magnified as a result of the stronger yen/dollar exchange rate. Premium income, net of reinsurance agreements, increased .5% to $3.2 billion in the first quarter. Net investment income, which includes amortized hedge costs on foreign investments, decreased 5.4% to $557 million.

Total revenues declined slightly by .4% to $3.8 billion. Pretax operating earnings declined 4.7% to $769 million.

In the first quarter, total new annualized premium sales decreased 29.2% to ¥22.1 billion, or $194 million. Third sector sales, which include cancer, medical and income support products increased 7.6% to ¥19.6 billion in the quarter. Total first sector sales, which include products such as WAYS and child endowment, were down 81.3% in the quarter, reflecting the company's actions to reduce the sale of first sector savings products that are more interest-sensitive.

AFLAC U.S.
Aflac U.S. premium income increased 1.7% to $1.4 billion in the first quarter. Net investment income was up 2.0% to $178 million. Total revenues increased 1.7% to $1.6 billion. The pretax operating profit margin for the U.S. segment was 19.7%, compared with 21.5% a year ago. Pretax operating earnings were $310 million, a decrease of 6.7% for the quarter. Results reflect first quarter 2017 investments in the U.S. platform as well as favorable benefit ratios in the first quarter 2016.
Aflac U.S. total new annualized premium sales increased 1.7% in the quarter to $333 million. Additionally, persistency in the quarter was 77.5%, compared with 76.6% a year ago.

DIVIDEND
The board of directors declared the second quarter cash dividend. The second quarter dividend of $.43 per share is payable on June 1, 2017, to shareholders of record at the close of business on May 24, 2017.

OUTLOOK
Commenting on the company's results, Chairman and Chief Executive Officer Daniel P. Amos stated: "We are pleased with the company's overall performance for the quarter. Our results for the first quarter are consistent with what we communicated on our December outlook call. Despite the persistent low-interest-rate environment, Aflac Japan, our largest earnings contributor, generated solid financial results. In yen terms, results on an operating basis were in line with our expectations for the quarter. Additionally, our operation in Japan produced better-than-expected third sector sales results. As we've communicated, we continue to believe the long-term compound annual growth rate for third sector product sales will be in the range of 4% to 6%.

"Turning to our U.S. operations, we are pleased with the financial performance and continued strength in profitability. Our results on an operating basis reflect ongoing investment in our platform and are in line with our expectations. As we've communicated, we anticipate a long-term compound annual growth rate of 3% to 5% in new annualized premium sales. I want to reiterate that as we look ahead, we believe the strategy for growth we implemented in both our career and broker channels is the right one, and we will continue to make tactical adjustments to meet our long-term growth objectives.

"We remain committed to maintaining strong capital ratios on behalf of our policyholders. We believe our financial strength in Japan positions us to repatriate in the range of ¥120 to ¥140 billion to the U.S. for the calendar year 2017, assuming capital conditions remain stable. We continue to anticipate that we'll repurchase in the range of $1.3 to $1.5 billion of our shares in 2017, front-end loaded in the first half of the year. As is always the case, this assumes stable capital conditions and the absence of compelling alternatives. Our objective is to grow the dividend at a rate generally in line with the increase in operating earnings per diluted share before the impact of foreign currency translation.
"I want to reiterate our 2017 earnings guidance. Our first quarter results put us squarely on track to produce stable operating earnings per diluted share of $6.40 to $6.65, assuming the average exchange rate in 2016 of 108.70 yen to the dollar. If the yen averages 105 to 115 to the dollar for the second quarter, we would expect operating earnings, a non-U.S. GAAP measure, to be approximately $1.55 to $1.70 per diluted share in the second quarter. As always, we are working very hard to achieve our earnings-per-share objective while also ensuring we deliver on our promise to policyholders."

ABOUT AFLAC
When a policyholder gets sick or hurt, Aflac pays cash benefits fast. For six decades, Aflac insurance policies have given policyholders the opportunity to focus on recovery, not financial stress. In the United States, Aflac is the leading provider of voluntary insurance at the worksite. Through its trailblazing One Day PaySM initiative, Aflac U.S. can receive, process, approve and disburse payment for eligible claims in one business day. In Japan, Aflac is the leading provider of medical and cancer insurance and insures one in four households. Aflac individual and group insurance products help provide protection to more than 50 million people worldwide. For 10 consecutive years, Aflac has been recognized by Ethisphere as one of the World's Most Ethical Companies. In 2016, Fortune magazine recognized Aflac as one of the 100 Best Companies to Work For in America for the 18th consecutive year and in 2017 included Aflac on its list of Most Admired Companies for the 16th time. In 2015, Aflac's contact centers were recognized by J.D. Power by providing "An Outstanding Customer Service Experience" for the Live Phone Channel. Aflac Incorporated is a Fortune 500 company listed on the New York Stock Exchange under the symbol AFL. To find out more about Aflac and One Day PaySM, visit aflac.com or espanol.aflac.com.
A copy of Aflac's Financial Analysts Briefing (FAB) supplement for the quarter can be found on the "Investors" page at aflac.com.