Prior Fiscal: $5.72 Billion
Percentage Change: +4.0%
No. of Employees: 35,125 (total)
Global Headquarters: Shinjuku-ku, Tokyo, Japan
Yasuo Takeuchi, Director, President, and CEO, Olympus Corp.
Chikashi Takeda, CFO, Olympus Corp.
Nacho Abia, COO, Olympus Corp.
Ken Yoshimasu, Olympus Medical Technologies Asia Head, Olympus Corp.; President, Olympus Medical Systems Corp.
Tomohisa Sakurai, Therapeutic Solutions Division Head, Olympus Corp.; President, Olympus Surgical Technologies America; Corp. Exec. VP, Olympus Corp. of the Americas
Frank Drewalewski, Endoscopic Solutions Division Head and Regional Representative Officer, Europe, the Middle East and Africa, Olympus Corp.
Julien Sauvagnargues, President and Regional Representative Officer, Olympus Corp. of the Americas
Randy Clark, President, Medical Systems Group, Olympus Corp. of the Americas
Olympus, which celebrated its 100th anniversary last October, has had its name dragged through the mud over the past few years due to a widely-publicized outbreak of infection from contaminated endoscopes. In December 2018, the company admitted it failed to file the necessary information with the FDA in 2012 and 2013 related to TJF-Q180V duodenoscope adverse event reports involving infections. Olympus also neglected MDR filings for infections in Europe.
Then-Olympus exec Hisao Yabe entered a guilty plea with the U.S. District Court in Newark, N.J., resulting in an $85 million fine to the company, a sum over 2.5 times Olympus’ total profit from sales of the misbranded endoscopes. Yabe also faced a maximum penalty of a year in prison and a $100,000 fine at the time.
However, Olympus’ former top regulatory official evaded the prison term, according to a report from Law360. Judge Stanley Chesler reportedly rejected the government’s request to sentence Yabe to prison for six months. His “personal and professional disgrace” also worked in his favor to dodge prison, Chesler said during sentencing, according to Law360. “You deserve to be professionally disgraced.”
Instead of prison, he was lightly slapped with one year of probation and a $5,000 fine.
ANALYST INSIGHTS: While hit short-term by the slowing of elective procedures, Olympus has the financial fortitude to stick to its market positions and to use the crisis as an opportunity to gain market share as surgeries begin to rebound again globally. With new products in its portfolio and the ability to execute opportunistic M&A, expect Olympus to enter 2021 in a stronger position than it started 2020.
—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
Yasuo Takeuchi began leading the Japanese conglomerate last April, and ushered it into a reasonably successful fiscal year (ended March 31, 2020). The medical device business—composed of endoscopic and therapeutic products—grew its revenue 4 percent over the previous year. The business was also simplified into global divisions Endoscopic Solutions (based in Japan) and Therapeutic Solutions (based in U.S.).
Olympus’ Endoscopic Solutions business rose a slight 1.6 percent, accruing 425.7 billion yen. Despite the company’s mainstay endoscopy systems reaching the second half of their lifecycles in developed countries, strong sales in China were maintained. Strong sales of Visera Elite II surgical endoscopy systems also boosted the business. Operating profit also grew due to improved cost-effectiveness and reduced expenses.
Topping off the year was January’s release of the Spiration Valve System (SVS) for severe emphysema. The umbrella-shaped endobronchial valve implant improves breathing by redirecting air from diseased lung sections to healthier areas. According to the valve’s Summary of Safety and Effectiveness, SVS therapy can reduce volume in the treated portion, promoting more effective function in the healthy lung areas.
The purported “world’s first endoscope with motorized rotation system” entered Europe and parts of the Asia-Pacific region in March. PowerSpiral’s mounted, foot-switch-operated, motorized, and rotating attachment gently grips the mucosa and pleats (folds) the small intestine for deeper advancement. High-definition images and a 3.2mm working channel also support diagnostic and therapeutic procedures.
CAD Open Platform AI-powered medical image analysis software became available for download in March as well. Users can switch between multiple CAD applications through connection to an Olympus GI endoscope to view computer-aided lesion detection and diagnosis in real time.
The ENF-VH2/V4 video rhino-laryngoscopes launched in September. An ergonomic grip and control allows more linear insertion to reduce friction between the scope and mucosa. The scope’s narrow band imaging provides useful luminosity to highlight tiny vascular and mucosal patterns using wavelengths absorbed by hemoglobin.
Therapeutic Solutions business proceeds remained flat at 216.1 billion yen. Sales of new flexible rhinology/otology and urology endoscopy products, as well as single-use endotherapy devices to diagnose and treat biliary and pancreatic ducts were solid. Earnings from single-use products of the Thunderbeat integrated energy device, and therapeutic devices for EBUS procedures continued to rise.
The ESG-150 Electrosurgery Generator, which supplies high frequency current to power endoscopes, hit the market last May. Its variety of waveforms accommodate monopolar and bipolar devices, delivering the lowest effective adjusted power output for standard gastrointestinal and pulmonary endoscopic procedures.
May also saw the release of Harostent self-expanding colonic (22, 25mm) and duodenal (22mm) metal stents (SEMS). Placed under fluoroscopic and endoscopic guidance, the SEMS’ design minimizes migration risk. An alternative to invasive surgery for colonic and duodenal obstructions, SEMS placement rapidly reverses symptoms like nausea, vomiting, abdominal discomfort, and weight loss. It can also be a bridge to surgery for acute colon obstruction until elective 1-stage surgery can occur.
The SnareMaster Plus hybrid hot/cold snare for polypectomy was added to the EndoTherapy line last September. A hexagonal shape and thin wire allow accurate tissue placement and precise cutting. Its two-in-one hot and cold feature eliminates the need for separate snares. According to data presented at 2015 Digestive Disease Week, cold snaring may also prevent post-polypectomy complications.
Olympus also began a few commercial and distribution deals last year:
- May—became exclusive distributor of Meditech Endoscopy’s Scope Pro-tech endoscopic tip protector
- October—assumed commercial activities for Ethicon’s Versapoint Electrosurgery system to treat intrauterine pathologies
- October—became exclusive distributor of EndoTherapeutics’ eSuction distal cap for retrieval of food bolus impactions, foreign bodies, and excised tissue
- November—became exclusive distributor of Rocamed’s RocaFlow Double Chamber Pump System and Tubing Sets for kidney stone ureteroscopy and trans-urethral resection of the prostate