Distributor of misbranded supplements fined $60,000
SILVER SPRING, Md. — Nikki Haskell, the owner and CEO of Balanced Health Products, has been sentenced by a U.S. magistrate judge in a Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug, the Food and Drug Administration reported Monday.
From at least November 2006 through December 2008, BHP’s primary business was the distribution across the United States of “Nikki Haskell’s StarCaps." BHP advertised StarCaps as weight-loss pills containing only all-natural ingredients including, for example, papaya extract. The company failed to list on the product’s label that the pills also contained bumetanide, a powerful diuretic used clinically to treat heart failure, kidney failure, high blood pressure and swelling (edema). Bumetanide is available in the United States only by prescription from a licensed physician.
In March 2014, Haskell was convicted upon a guilty plea to distributing the misbranded StarCaps from BHP’s New York City-based location. Per Haskell, the company is now defunct and has filed for bankruptcy.
Agents from the FDA’s Office of Criminal Investigations, New York Field Office spearheaded this investigation, which led to the permanent removal of this tainted dietary supplement from the market.
“There is a strict regulatory process in the United States for the distribution and dispensing of prescription drugs, and dietary supplements cannot legally contain such drugs,” stated Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “Consumers rely on the labels of dietary supplements to inform them about any potential health risks. The FDA will continue its vigilance over the dietary supplement market.”
Use of bumetanide is banned by certain professional sports organizations, including the National Football League, in part because bumetanide can mask the presence in the human body of steroids and other banned doping agents.
Walgreens to open Wrigley Building flagship
Walgreens helps celebrate the storied history of the Wrigley Building with a mural of the famous Wrigley Building Clock on the floor and stretching onto the wall, according to the report.
“I think of flagships as being the amplification of a brand and what it stands for and its role in people’s lives,” Joe Jackman, CEO of Jackman Reinvention who has contributed to the design of 14 flagship stores, told the Chicago daily. “The first one we did in Chicago was State and Randolph. It was very, very exciting to see not only the customer community, but the internal community get excited. It’s tangible, I can see it. Flagships can be amazing laboratories for exploring where a brand might go.”
Walgreens posts 5.9% lift in Q3 sales; considering second step of Alliance Boots transaction
DEERFIELD, Ill. — As Walgreens carefully considers how to best execute the second step of its acquisition of Alliance Boots, Walgreens on Tuesday relayed its progress in improving its domestic business, including the company’s success in winning the prescription business of high-value seniors and the pending national launch of its Boots No7 beauty brand.
"To drive our [pharmacy] performance we’ve been making deliberate, strategic decisions to win with high-value seniors," Greg Wasson, Walgreens president and CEO, told analysts Tuesday morning. Walgreens targets baby boomers through preferred relationships with Medicare Part D plans, by growing 90-day at retail and by expanding vaccines and other preventative care services, Wasson said. "These decisions continue to drive growth in the quarter, contributing to strong top-line growth," he said. Walgreens recorded an 11.6% increase in Medicare Part D prescriptions in the third quarter as compared to the comparable year-ago period. "Part D marketshare increased 60 basis points this May, compared to the same month last year, and overall 90-day volume was up 15%," Wasson added.
Across the front-end, Walgreens is preparing to launch its Boots No7 brand nationwide after successful introductions in the Phoenix and New York markets. "To further engage our beauty customers, we extended the reach of Boots brands," Wasson said. "In New York, one of the country’s most important beauty markets, we currently have Boots brands in more than 125 Walgreens and Duane Reade stores, with a goal of 183," he said. "From New York we will begin our launch across the United States."
That iconic brand launch will augment the improved beauty experience Walgreens has realized. "As we prepare for that expansion, results are coming in from Phoenix, our most mature market for Boots No7, and it’s clear our new beauty experience is elevating our performance," Wasson said. "Boots No7 is the No. 1 skin care brand sold in all of our Phoenix stores. And baskets with Boots items are bigger than the average beauty basket. In addition, 80% of our beauty customers tell us their beauty experience is improving." Boots No7 is also the best-selling beauty brand on Walgreens.com.
Walgreens on Tuesday posted $19.4 billion in sales, up 5.9%, for the third quarter ended May 31. Sales for the first nine months increased 5.6% to $57.3 billion.
“We continued to see improving top-line growth in the third quarter driven by increased daily living sales and strong increases in both prescriptions filled and our pharmacy market share,” stated Wasson. “At the same time, we are experiencing increased pressure on pharmacy gross profit margins. We maintained solid expense control in the third quarter to offset some of this pressure while understanding that there is more to be done. We will be accelerating our optimization efforts, including taking additional steps to lower expenses companywide," he said. "In addition, our joint venture with Alliance Boots continues to generate significant benefits.”
Front-end comparable store sales increased 2.2% in the third quarter, customer traffic in comparable stores decreased 0.7% and basket size increased 2.9%, while total sales in comparable stores increased 4.8%.
Prescription sales, which accounted for 64.4% of sales in the quarter, increased 8.4%, while prescription sales in comparable stores increased 6.3%. The company filled 218 million prescriptions in the quarter, an increase of 4.5% over last year’s third quarter. Prescriptions filled in comparable stores increased 4.1% in the quarter. As of May 31, Walgreens increased its retail prescription market share 20 basis points from a year ago to 19% as reported by IMS Health on a 30-day adjusted basis.
Walgreens also saw strong growth in prescriptions filled for Medicare Part D patients, which increased 11.6% in the third quarter compared with last year’s quarter, while the company’s Part D market share increased 60 basis points in May compared with the same month a year ago.
Walgreens Balance Rewards loyalty program reached 81 million active members at the end of this year’s third quarter.
The combined synergies for Walgreens and its strategic partner, Alliance Boots, in the first nine months of fiscal 2014 were approximately $367 million. The joint synergy program is now estimated to deliver second-year combined synergies of $400-$450 million, an increase from the previous second-year estimate of $375-$425 million. Alliance Boots contributed 15 cents per diluted share to Walgreens third quarter 2014 adjusted results. The company estimates that the accretion from Alliance Boots in the fourth quarter of fiscal 2014 will be an adjusted 6 to 7 cents per diluted share. This estimate does not include amortization expense, the impact of AmerisourceBergen warrants or one-time transaction costs, and reflects the company’s current estimates of IFRS to GAAP conversion and foreign exchange rates.
Walgreens board of directors is moving forward toward consideration of the second step in the Walgreens-Alliance Boots strategic transaction, including determination of timing and structure, combined management teams, cost reduction initiatives and potential changes in the company’s future capital structure.
“[Executive chairman of Alliance Boots] Stefano Pessina and I are working hard to realize our joint vision for exercising step two of the Walgreens-Alliance Boots strategic transaction for consideration by the Walgreens board of directors,” Wasson said. “We are working through complex issues in planning for step two, and we are taking the appropriate time to come to the right resolution for the combined enterprise.”
As a result of the many step two considerations and current business performance, the company is withdrawing its fiscal year 2016 goals that were previously announced in 2012. Specifically, once key decisions have been made on the above matters, Walgreens anticipates being in a position to hold an investor call, which is expected to occur by late July or early August. At that time, the company expects to provide a new set of goals and metrics for the proposed combined enterprise for fiscal year 2016.
Net earnings totaled $722 million, representing a 15.7% increase from the same quarter a year ago. This year’s third quarter earnings benefited from a lower GAAP effective income tax rate. Adjusted fiscal 2014 third quarter net earnings were $883 million, an 8.7% increase from $812 million in the same quarter a year ago. This year’s adjusted third quarter earnings also benefited from a lower effective income tax rate. Adjusted net earnings per diluted share for the quarter increased 7.1% to 91 cents, compared with 85 cents per diluted share in the year-ago quarter.
GAAP total gross profit dollars increased $218 million, or 4.2%, compared with the year-ago third quarter, with gross profit margins decreasing 40 basis points versus the year-ago quarter to 28.1 as a percentage of sales. Adjusted gross profit dollars increased $139 million, or 2.6%, compared with the year-ago third quarter.
Pharmacy gross profit dollars were negatively impacted by lower third-party reimbursement, fewer brand-to-generic drug conversions compared with the year-ago quarter, and generic drug price inflation. Both pharmacy and front-end margins benefitted from purchasing synergies from the company’s joint venture with Alliance Boots. The LIFO provision was $41 million in this year’s third quarter versus $120 million last year.
Walgreens delivered free cash flow of $1 billion in the third quarter and operating cash flow of $1.3 billion in the quarter, as lower inventories drove improvements in working capital. Inventories benefited from the company’s distribution agreement with AmerisourceBergen.
The company opened or acquired 39 new drug stores in the fiscal 2014 third quarter, the same number opened or acquired in the year-ago quarter.
As of May 31, Walgreens operated 8,683 locations. The company has 8,217 drug stores nationwide, 120 more than a year ago. Walgreens also operates worksite health and wellness centers, infusion and respiratory services facilities, specialty pharmacies and mail service facilities. Its Take Care Health Systems subsidiary manages more than 700 in-store convenient care clinics and worksite health and wellness centers. Walgreens e-commerce business includes Walgreens.com, drugstore.com, Beauty.com, SkinStore.com and VisionDirect.com.