Category: Health Care & Insurance

Array BioPharma shares spike following 2Q earnings report

BOULDER — Shares of Array BioPharma Inc. (Nasdaq: ARRY) had surged nearly 12 percent by mid-afternoon trading Thursday after the release of the company’s fiscal year-end earnings report.

The gains came despite a net loss for the year ending June 30 of $92.8 million as the Boulder-based firm continues with Phase 3 trials for multiple cancer drugs and prepares for commercialization.

Array’s net loss equated to 65 cents per share and compared with a net income of $9.4 million, or 7 cents per share, for the previous fiscal year, which was bolstered by a one-time $80 million payment from Novartis related to Array’s binimetinib and encorafenib programs.

Revenue for the 2016 fiscal year climbed to $137.9 million, up from $51.9 million the previous year, also due largely to reimbursement revenue from Novartis.

Array in June submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the use of binimetinib in the treatment of NRAS-mutant melanoma. The drug is also being examined in a pair of other Phase 3 trials in combination with other drugs to treat BRAF melanoma and colorectal cancer.

Array’s share price has climbed steadily since February, and was at $4.58 by mid-afternoon Thursday, up 48 cents from Wednesday’s close.

CSU researchers to study Swiss firm’s attempt to fight Zika virus

FORT COLLINS — Researchers at Colorado State University will conduct federally sponsored tests of a Swiss company’s citrus-based insecticide to see if it’s effective against mosquitoes carrying the Zika virus.

The research is being sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. CSU researchers, working under NIAID’s preclinical services program, will test the repellency and insecticidal properties of nootkatone, an insecticide produced by Evolva (SIX: EVE), a company based in Reinach, Switzerland. Data from the studies will supplement Evolva’s research to fulfill Environmental Protection Agency requirements for the commercial launch of nootkatone in the United States.

Zika is one of a number of mosquito-borne viruses, which include both dengue and chikungunya, that are transmitted by two species of mosquito. The World Health Organization and the federal Centers for Disease Control and Prevention have declared the virus a public health emergency because it is associated with potentially severe neuropathogenic and neurodevelopmental conditions in humans.

CDC research already has shown that nootkatone repels and kills a mosquito that can transmit Zika and yellow fever, as well as the black-legged tick that transmits Lyme disease.

Evolva also produces the sweetener known as stevia. Nootkatone can be extracted in minute quantities from the skin of grapefruit or the bark of the Alaska yellow cedar, or produced on an industrial scale from brewing via yeast fermentation.

Investment firm buys majority stake in Firefly Medical

FORT COLLINS — Carlton-Harvey Group, a Georgia-based private-equity firm, has acquired a majority stake in Fort Collins medical-device startup Firefly Medical Inc., as the latter aims to significantly scale up sales.

Carlton-Harvey invested $2.5 million in Firefly, according to a recent regulatory filing, and Firefly co-founder Patrick Bols said Wednesday that there is also an undisclosed loan commitment aside from the equity portion.

Bols, who has served as chief executive for the past year, becomes chairman of the Firefly board with the new transaction. CHG principal Trevor Carlton, meanwhile, will take over as CEO of Firefly, and CHG principal Stuart Harvey becomes president.

Firefly, 320 E. Vine Dr., will keep its branding, and all eight employees who were with the company prior to the CHG investment will remain.

“Everybody still has a very important job to do here,” Bols said.

The addition of Carlton and Harvey, as well as a new sales manager, boosts the company’s employee count to 11, and Bols said the intent is to add two more employees this year and three to five more in 2017. The new cash infusion will be used largely to beef up sales and marketing, including internationally.

“The most important part of this transaction is we’ll now have seasoned executives managing the company,” Bols said.

Founded in 2013 by Bols, Steve Schmutzer and Keith Burge, Firefly makes a device called the IVEA that aims to replace the standard pole from which IV bags are hung in order to improve patient mobility, nursing staff efficiency and safety for both patients and caregivers.

Firefly officially launched the device in May of last year. Bols declined to disclose revenue.

“Almost immediately we recognized that the IVEA is a solution that could transform the industry,” Carlton said in a news release. “It’s a great story and a great product, and we look forward to working with Firefly to make the IVEA the new standard of care in hospitals around the world.”

Correction: The original version of this story mis-labeled Carlton-Harvey Group as a Fort Collins-based firm. We regret the error.

German firm Sartorius acquires Broomfield-based ViroCyt

BROOMFIELD — Life-science startup ViroCyt LLC announced on Friday that the company has been acquired by Germany-based Sartorius, an international provider of pharmaceutical and laboratory tools.

Sartorius paid $16 million for Broomfield-based ViroCyt in the cash deal.

ViroCyt president and CEO Robert Kline said in an interview Friday that the company will maintain its branding and continue to operate as a standalone company for the foreseeable future. He said all 12 employees, including him, will be retained.

Formed in late 2012 as a spinoff of Boulder-based InDevR, ViroCyt develops instrumentation and reagents that allow for the quantification of virus particles in a given sample in just minutes. The company is projected to achieve more than $3 million in sales this year.

“We’ve really been able to fine-tune and improve our technology to the point that I think it’s a really good solution for a number of opportunities and applications in the biotech world,” Kline said. “But as a small company we don’t have the reach to get to all of the opportunities. … (The acquisition) is a great opportunity to accelerate the scaling of our business.”

ViroCyt, which initially was based in Denver, launched with $3 million in venture capital, led by High Country Venture in Boulder. The company last year added another $3.5 million round. The company moved to Boulder in late 2013 before moving again to Broomfield last November to accommodate growth.

Eight of ViroCyt’s employees are based at the company’s headquarters at 100 Technology Drive in Broomfield, with the rest spread throughout the country. Kline said the acquisition by Sartorius should mean more hiring locally.

“The whole idea behind the partnership is to grow the business, so over time we will be adding resources,” Kline said.

Troubled Louisville biopharma GlobeImmune to delist its stock from Nasdaq exchange

LOUISVILLE — Having failed in a yearlong quest to find a buyer or other “strategic transaction” for the company, officials for GlobeImmune Inc. disclosed in a regulatory filing on Tuesday that they plan to delist the firm’s common stock from the Nasdaq Capital Market exchange.

The move continues the downward spiral for the Louisville biopharmaceutical company, which suffered a crippling blow last year when clinical trial results for its hepatitis B drug candidate revealed that the drug did not show a reduction of the disease at the end of a 24-week study.

Down to 2.5 full-time employees, GlobeImmune (Nasdaq: GBIM) in May of this year received a delisting warning from Nasdaq for falling out of compliance with a rule requiring minimum stockholders equity of $2.5 million, as well as alternative benchmarks for market cap and net income from continuing operations. At that time, GlobeImmune had a 45-day grace period to submit a plan for regaining compliance but has instead opted to voluntarily delist.

GlobeImmune’s share price plunged 36 percent Wednesday on the news of the delisting plans. Shares were trading at $1.15 apiece by late afternoon.

The company will making a formal filing with the U.S. Securities and Exchange Commission on July 15 officially notifying the regulatory body of its plans to delist and deregister its common stock. GlobeImmune expects the filing to become effective July 25, at which time the company will request the suspension of its financial reporting obligations as well.

Following the effectiveness of the delisting, GlobeImmune officials expect the company’s stock to begin trading on the OTC Market’s Pink market tier under the company’s current ticker symbol of GBIM.

“The Board made the decision to allow the Common Stock to be delisted from NASDAQ and to seek deregistration under the Exchange Act following the Company’s review and careful consideration of several factors including the inability to find a suitable strategic transaction despite a comprehensive year-long process, the ongoing listing, legal, administrative and additional accounting costs associated with being a publicly listed company, the non-compliance letter received from NASDAQ for the continued listing requirements, the inordinate amount of executive time and Company resources consumed in regulatory compliance obligations and the lack of investor interest as shown in the low daily trading volumes of the Common Stock on NASDAQ,” company officials wrote in the Form 8-K filed Tuesday. “The Board determined that delisting and deregistration are in the overall best interests of the Company and its stockholders.”

In the company’s first-quarter earnings report in May, GlobeImmune officials disclosed that they could be forced to shut down the company if a strategic alternative, such as a buyer, is not found “in the near future.” They added that the company has enough cash to operate as a going concern through the middle of next year, but that a decision to wind down the company would burn through its cash more quickly.

GlobeImmune laid off all but six of its 22 employees last summer following the negative trial results. As of the company’s most recent quarterly report, only vice president Jeffrey Dekker and a scientist remained onboard full-time, while chief executive Timothy Rodell is a half-time employee at this point.

GlobeImmune is focused on developing products for the treatment of cancer and infectious diseases. The company has three ongoing clinical trials being conducted by Gilead Sciences Inc. and Celgene Corp.

GlobeImmune was founded in 1995 as a spinoff of University of Colorado technology. The company raised a Series A funding round in 2003 and pulled in a total of $119 million in private equity before going public in 2014 with a $17.25 million initial public offering.

Array BioPharma submits melanoma drug for FDA approval

BOULDER — Array BioPharma (Nasdaq: ARRY) this week submitted a New Drug Application with the U.S. Food and Drug Administration for the use of drug candidate binimetinib in the treatment of NRAS-mutant melanoma.

The submission is the first for Boulder-based Array, which has several drugs in the development stage. It comes on the heels of positive Phase 3 trial results for binimetinib that were released earlier this month.

Array shares spiked as high as $3.82 Friday morning from Thursday’s close of $3.56 before gradually settling back to $3.62 by mid-afternoon trading.

If granted, FDA approval of the first NDA could mark just the beginning for binimetinib. The drug is being examined in a pair of other Phase 3 trials. One is looking at the use of binimetinib in combination with Array drug encorafenib in the treatment of BRAF-mutant melanoma. Another is looking at the combination of both of those drugs, along with Merck drug Erbitux, in the treatment of colorectal cancer.

Another Array drug, selumetinib, is licensed by AstraZeneca, which is conducting Phase 3 trials looking at the drug in the treatment of lung cancer and thyroid cancer.

JustRight Surgical gains additional FDA approval

LOUISVILLE — JustRight Surgical LLC in Louisville said Tuesday it has received additional clearance from the FDA for one of its electrosurgical devices, making it the first instrument cleared for use specifically for surgeries involving pediatric patients.

The JustRight Surgical Vessel Sealing System already had FDA approval and is being used in surgeries on adults and children. But questions have been posed on the safety of bulkier tools using high power to create the heat to cauterize tissue in children.

Company spokeswoman Patti Hoag explained that doctors have the choice to use whatever device they want to seal vessels in adults and children, and the FDA approved electrosurgical devices 15 years ago.

This clearance, she said, says Just Right’s vessel-sealing device is safe to use in extremely tight or small spaces found in teens, children, infants and neonates.  The new, low-power vessel-sealing technology was found to permanently fuse vessels while using significantly less energy.

“This additional clearance will allow us to market the device as being safe for pediatric surgery,” Hoag said.

Russ Lindemann, president and chief executive of JustRight Surgical, said pediatric surgeons have been requesting “right-sized” surgical instruments and technologies for years.

“This validates the truly unique technical advancements made by our development team. … We are the only surgical-device manufacturer to focus solely on pediatrics. Now, surgeons and hospitals are recognizing the value we bring to caring for the smallest of patients.”

JustRight Surgical’s instruments are being used for general and thoracic procedures in more than 100 children’s hospitals in the United States and Europe. JustRight Surgical has the only 5-millimeter stapler using the classic titanium wire staple in a clinically accepted “B” shape along with the 3- millimeter vessel sealer.

Louisville-based GHX acquires Omaha software firm

LOUISVILLE — Health-care supply chain company Global Health Exchange LLC in Louisville said Tuesday it has acquired Omaha, Neb.-based H-Card LLC that provides automated payment-management software and services to health-care providers and suppliers in the United States.

Financial terms of the deal were not disclosed.

The acquisition, GHX’s second in 19 months, expands the company’s financial-products portfolio.

H-Card LLC, which uses the brand Hap-X, will operate as a wholly owned subsidiary.

The combined product offering gives GHX the ability to provide customers both software and services within the health-care supply chain.

The Hap-X payment exchange enables providers and suppliers to align payment, remittance and reconciliation information together to create operational efficiencies for both providers and suppliers.

“Hap-X is a great addition to the GHX family,” said Bruce Johnson, GHX’s president and chief executive. “This is an acquisition our customers have been asking us to complete in order to help them solve the payment-management challenges that are adding costs to health care.”

GHX offers cloud-based supply-chain management technology and services. GHX has an electronic trading exchange that delivers procurement and accounts payable automation, contract and inventory management, vendor credentialing and management, business intelligence, and other supply chain-related tools and services. About 4,000 hospitals and 18,000 provider facilities are clients of GHX.

Manufacturing CEOs: Finding skilled talent presents challenges

FORT COLLINS — Leaders of manufacturing firms in Northern Colorado face challenges in maintaining a skilled workforce, providing quality health care for their workers and figuring out how to best handle employees who might partake in the use of recreational marijuana.

They also say costs associated with new and changing regulations issued by the Occupational Safety and Health Administration through the Department of Labor erode the bottom line, often affecting their ability to hire needed workers.

“We are growing quickly,” said Todd Whitbeck, chief financial officer of Water Pik Inc. in Fort Collins, who said he has about 15 to 20 job openings.

“Electrical and hydraulic engineers are hard to find here,” he said. “We’ve had to hire engineers in China.”

Entry-level employees with basic skills are also hard to find, said most of the executives who participated in BizWest’s CEO Roundtable on manufacturing Tuesday morning in Fort Collins.

Steve Anderson, president and chief executive of Forney Industries Inc. in Fort Collins, said there is a gap between baby boomers and millennials for welders and the trades in general.

Anderson is trying to fill that gap by offering scholarships to students to attend Front Range Community College’s trade classes.

“We’ve had some success working with Front Range as well as Colorado State University’s supply-chain management forum,” Anderson said. The forum provides partner companies with the opportunity to interact with CSU supply-chain faculty, supply-chain students and other company partners.

Dean Herl, general manager of Greeley-based Noffsinger Manufacturing Co. Inc., a maker of equipment for the agriculture industry, said it is difficult to find young qualified workers.
“The average age of our tech workers is 56. We will see turnover there. Instead of hiring someone with 10 years of experience, we have dropped that to five years of experience,” he said.

With a shallow talent pool, Anderson said an emerging trend is that blue-collar workers will demand higher wages. Tim Reeser, president and co-founder of Lightning Hybrids in Loveland, said he’s having to pay machinists more than engineers.

Terry Precht, CEO and president of Vergent Products in Loveland that designs and manufactures products for its clients, said he sees a shortage of electrical engineers.

“We want a candidate that has a two-year degree in electronics that has received a hands-on education,” Precht said. “For skilled assembly, a two-year degree is worth its weight in gold.”

Fort Collins-based trailer manufacturer Maxey Cos. merged with Pennsylvania-based MGS Inc. in 2014. Carl Maxey said as his company has ramped up assembly lines to two shifts during the past 18 months in Fort Collins, finding workers with the needed skills is a problem.

“We’ve tried to transfer employees from Pennsylvania to Colorado, but housing becomes a problem with the higher cost of homes here,” Maxey said. “We’ve had to take on the responsibility to train people.”

Garth Rummery, owner of Tharp Cabinet Co. in Loveland, also is training his own people.

“We look for good people who have a good personality, work hard and are team players. We have enough core knowledge to be able to train them ourselves.”

Marcia Coulson, president of Denver-based Eldon James Corp. that is planning a facility in Fort Collins, said her company looks for people with a strong work ethic and are able to pass a drug test.

Recreational marijuana

“Our employees need to be thinking,” Coulson said. “One employee could be responsible for a million-dollars-worth of equipment. “They need all their senses,” referring to people who may come to work with a THC hangover or take a “smoke” break.

Maxey said the problem is that the state has not issued guidelines on what constitutes too much THC, the mind-altering ingredient in marijuana.

“It’s not defined. … And as employers, we cannot afford the risk of injury.” He said when an employer sends someone home because of alcohol use, “it is never challenged.”

Lisa Clay, CEO of her family business, Advance Tank & Construction Co. in Wellington, hires welders from across the country for projects her firm has across the United States. But she has more difficulty hiring in Colorado, where recreational use of marijuana is legal.

“I don’t have a choice. I say right up front, ‘don’t waste my time, can you pass a drug test?’ I’m waiting for someone to quantify the level of THC that is safe.”

Reeser said the state has done a poor job on educating about the effects of marijuana. “It is not as harmless as we are led to believe,” he said.

Health care

Most manufacturers in the room Tuesday lamented the direction health-care is taking but are even more wary of Amendment 69 that will be voted on in November.

The amendment to the state constitution would create ColoradoCare, a payment system designed to finance health care for Colorado residents partly through an approximately $25 billion increase in state taxes that would be paid by businesses and employees.

“This will have bad consequences,” Clay said. “It wasn’t good for Vermont or Massachusetts; so why would it be good for Colorado? We (as a company) might have to cut jobs or move out of state.”

Reeser conjectured that in the system will have a lot of waste and offer poor service.

Participants in Tuesday’s CEO Roundtable included: Steve Anderson, president/CEO, Forney Industries; Lisa Clay, CEO, Advance Tank & Construction Co.; Marcia Coulson, president, Eldon James Corp.; Dean Herl, general manager, Noffsinger Manufacturing Co. Inc.; Carl Maxey, president, Maxey Cos.; Terry Precht, CEO/president, Vergent Products; Tim Reeser, president/co-founder, Lightning Hybrids Inc.; Garth Rummery, owner, Tharp Cabinet Co.; Todd Whitbeck, chief financial officer, Water Pik Inc. Moderator: Christopher Wood, co-publisher/editor, BizWest Media.  Sponsors: Luis Ramirez, David Fritzler and Luis Gutierrez, BBVA Compass; Jim Sampson and Russ Henniger, Hub International Insurance Services; Brian Rooney, Kreg Brown and Mike Grell, EKS&H LLLP. 

Treehouse Health launches in Boulder, offering new way to treat myopia

BOULDER — Matt Oerding and Dr. Gary Gerber have launched their startup Treehouse Health LLC in Boulder to take advantage of the area’s startup scene.

The company, formed in 2015, plans to open Treehouse Eyes eye-care centers that will offer a patent-pending method of treating myopia, or nearsightedness, which causes blurry distance vision.

“Boulder has an amazing startup scene with best-in-breed professional services for entrepreneurs,” said Oerding, the company’s chief executive and co-founder. “Our legal counsel, CFO, accountant, business banker and CPA are all here and specialize in working with startups. We’re excited to play a role in the growing health-care arena happening in Boulder.”

Right now, Oerding is running the company out of the Impact Hub Boulder at 1877 Broadway. The company has six employees, including Oerding and Gerber, who works from New Jersey.

The company raised $2 million in seed funding in less than six months. The company’s advisory board includes experts in myopia control and Lenscrafters’ founder Dean Butler.

Oerding said the Treehouse treatments can slow or stop the progression of near-sightedness, but does not reverse it.

“There are more than 10 million children with myopia in the United States, and that number is expected to increase to 30 million by 2025,” Oerding said.

Myopia generally is caused by genetics, but among the reasons for the increased number of children with myopia is that they are spending more time looking at a screen on a digital device and less time outdoors where they would use their distance vision, he said.

Erin Stahl, pediatric ophthalmologist and investor in Treehouse Eyes, said the types of treatments Treehouse Eyes offers are noninvasive and supported by strong evidence of their effectiveness and safety.

“Most eye doctors have busy practices, which makes it difficult to recommend and provide the types of customized treatments Treehouse Eyes will offer,” Stahl said. “I’m excited there is finally a place dedicated to providing this type of needed service for children with myopia.”

The first two Treehouse Eyes centers will open in the Washington, D.C. suburbs — Bethesda, Md., at the end of July, and Tysons Corner, Va., in August, areas that have a high prevalence of myopia, Oerding said.

Current plans include expansion in major markets across the United States with a goal of opening more than 20 centers in the next two years. Oerding couldn’t say when a center would be opened in the Boulder Valley.

The centers are designed to be engaging and inviting and will offer appointments designed to accommodate the schedules of parents and children, including before and after school and on the weekends.

“We want our centers to be a uniquely nurturing and positive space offering families diagnosed with myopia a new pathway to better vision for life,” said Oerding. “We’re challenging the status quo around vision care and have the opportunity to help kids see a brighter, and clearer, future.”