Cancer diagnostics firm aiming for turnover of $123 million within five years

Key to Pacific Edge's performance this year has been its forays into the lucrative United States health market, where it is now concentrating on spending millions of dollars on marketing its non-invasive bladder cancer diagnostic tool - Cx-bladder.

During the past year the company has notched up massive share price gains, signed up numerous large US health organisations and most recently completed a successful, oversubscribed almost $29 million capital raising, its second for a similar amount in the past two years.

For Pacific Edge's deep pocketed shareholders, 2014 could be the year of redemption, as research and development spending to the year-ended March 2014 is estimated to be $46 million.

Dunedin businessman and accountant Chris Swann has been with Pacific Edge since its inception, initially as a financial adviser from the early-2000s, then as a director from 2005 before becoming its chairman in 2007.


He credits Pacific Edge's success back to its inception days, led by Parry Guilford, the large skill-base within the University of Otago and in its commercialising of "raw" intellectual property rights.

Professor Guilford is principal investigator at the university's Cancer Genetics Laboratory in Dunedin and Pacific Edge's chief scientific officer.

"We've used New Zealand, as the home market, to develop and prove the research and the standard operating procedures for lab work. It is the knowledge base," Swann said.

Pacific Edge's Cx-bladder uses a non-invasive urine sample for testing. Its certified labs in Pennsylvania and Dunedin can respectively process up to 260,000 and 35,000 tests annually.

He estimated that while Pacific Edge spent $46 million on research and development, it would have cost ten times that to achieve similar results in the US.

"We've [also] been fortunate to have a very loyal and large shareholder base, which has helped immensely in the longer term," Swann said, in light of the company not yet having posted a profit.

He reiterated earlier estimates, of achieving an annual US$100 million ($123 million) turnover within five years, noting the US$100 million was mid-range of estimates.

While holding numerous patents in the US, Asia, China, Singapore, Europe and Japan, "the United States is the sole focus for 2014, with all our energies going into that," Swann said.

"Trying to commercialise in a lot of countries, all at once, would be a recipe for disaster."

The new Cx-bladder diagnostic test costs around around $320, while the conventional full, invasive clinical test in New Zealand can cost between $1750 and $2200.

Cx-bladder is being trialled and looked at by health boards around New Zealand, and in Europe and Asia, but it's the large US market which holds the most short- to medium-term promise.

Pacific Edge employs about 18 staff in Dunedin, including management, administration and lab technicians, a further 10 in Pennsylvania, plus an expanding US marketing team of six, which is expected to grow to 25.

The Pennsylvania lab has the capacity to process 260,000 tests a year and Swann is confident the company will be processing "several tens of thousands of tests" during 2014.

While the molecular science developed in Dunedin is closely guarded, and a large number of patents are held and regularly updated in countries around the world, pricing is a key selling point for healthcare providers.

Swann estimated that intellectual property rights, or patents applications and constant updating, has cost Pacific Edge $5 million to $6 million, but patents are crucial for maintaining its competitive edge.

He was less concerned about the molecular science being copied by competitors in the future - because Pacific Edge is always developing and updating it which acted as a buffer - than by the potential for a breakthrough elsewhere in technology.

"This is why we are developing and want to have a broader range of tests [eventually]," Swann said, of expanding Cx-bladder uses, but also applying more research into cancers, such as melanoma, bowel and colorectal.

Having gained regulatory approvals to open its $4.5 million Pennsylvania lab, which allowed its growing marketing team to go out and sell the product, its shares began to spike, followed by more news of landing US contracts with health network suppliers.

From a trading range within 40c-70c during most of the year, in early-October its shares skyrocketed about 250 per cent to hit $1.50, and have since eased to trade about $1.30.

As at December 24, Pacific Edge had a market capitalisation of $413 million. A recent agreement with the FedMed network encompasses 4000 hospitals, 550,000 physicians and 60,000 ancillary care providers - which is accessible to approximately 40 million Americans.

The politically divisive Obama-care health plan in the US also offers Pacific Edge the tantalising potential for more health customers, numbered again in the tens of millions.

However, the next crucial step is Pacific Edge gaining clearance from the Centre for Medicaid and Medicare Services (CMS), which oversees and reimburses payments for the US public health system.

Swann welcomed Obama-care, but the legislative changes mean Pacific Edge has to wait longer and make changes to gain CMS accreditation, though he is hopeful it will be through early next year.

Pacific Edge's shareholders have poured more than $40 million into product development since its listing in 2003, including a $20 million capital raising in 2012 and most recently a $29 million renounceable rights issue, while yet to book a profit.

The latest capital raising leaves Pacific Edge about $30 million in the black, to underpin marketing, distribution and testing costs of its mainstay Cx-bladder product.

At its annual shareholder meeting in Dunedin in August, chief executive David Darling had initially batted away suggestions of a company sale to the large pharmaceuticals, but conceded that, given time, an offer could be expected.

Craigs Investment Partners broker Peter McIntyre said Pacific Edge became the "share market darling of the year", with a series of positive announcements which eventually saw its market capitalisation rise from $100 million to more than $400 million.

"Pacific Edge really created a buzz in the sector ... it showed a global business really can be run from Dunedin," he said.

Investors had been impressed the company had come through with results from being focused with a "regimented approach" to planning, targeting markets, opening its laboratory and setting goals in marketing Cx-bladder to organisations and urologists, he said.

McIntyre said while the company operated in a fast-growing sector with a lot of competition, it had protected its intellectual property well and was several years ahead of competitors.

"A buy-out from a big pharmaceutical company could be an option; there's every chance of that happening in the future," he said.

McIntyre said development of new products, some linked to Cx-bladder research and other cancer types, would likely be a focus for Pacific Edge.

Forsyth Barr broker Haley Van Leeuwen noted Pacific Edge's success during the year may see it included in the New Zealand stock exchange's top 50 companies index early next year, which could displace fashion retailer Hallenstein Glasson.

"Pacific Edge is lucky to have many supportive investors who love the story behind their product and the 'feel-good' factor behind what they do, especially those that have in some way been affected by bladder cancer," she said.

Setting up in the US was done in a period of low interest rates and the market was now looking for revenue from the new contracts and more urology practices being signed up, she said.