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Following Restructuring, New Sequencing-specific Products, WaferGen Eyes Top-Line Growth in 2014

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A week after announcing 2013 revenues of $1.3 million — more than double its 2012 revenues — WaferGen Biosystems this week set a lofty goal of more than $5 million for its top line in 2014 as it looks to continue its financial turnaround.

In the company's first earnings call since its 2012 restructuring and management change, CEO Ivan Trifunovich outlined the current state of WaferGen's business and future direction, noting that the company has made "a great deal of progress … with a series of tangible milestones and achievements" over the past two years.

The first of these goals included installing a new management team, including Trifunovich, in 2012, and launching the SmartChip MyDesign — an open format for high-throughput gene expression experiments on its SmartChip Real-Time PCR system — which Trifunovich said garnered the company multiple system placements in the second half of 2012.

"These were the first system sales after six quarters of struggle to find the right formula for success under the old strategy," Trifunovich said.

Next, in January 2013 WaferGen announced a prototype and preliminary positive results of SmartChip TE, a new modification enabling the SmartChip system to be used for target enrichment in front of next-generation sequencing experiments.

The company followed this up in May 2013 with the launch of a SmartChip TE early access program and, "based on the initial success, in September 2013 we were able to raise $13.4 million in net capital and drastically simplify our capital structure," Trifunovich noted.

"SmartChip TE performs a critical patient sample preparation step prior to sequencing," Trifunovich explained during the call. "The key step is copying the targeted genes millions of times so that enough material is present for the sequencing to work."

He added that undisclosed third-party labs have confirmed that SmartChip TE performs this step "more evenly than competing products" such as ThermoFisher Scientific's Ion Ampliseq, Illumina's TruSeq, and Agilent Technologies' HaloPlex, the upshot being that SmartChip TE "enables NGS machines to produce a more accurate diagnostic test result."

WaferGen has not disclosed many of the early access users of SmartChip TE, though China's BGI is one. In January, Xun Xu, deputy director of BGI Research told In Sequence that his lab has used the system in two projects, one to capture 36 amplicons in a total of 800 samples, another to capture 72 amplicons in 200 samples. Xu also noted that, compared to both hybridization- and PCR-based alternative approaches, the SmartChip TE achieves "better coverage and evenness for the regions of interest."

Further detailing WaferGen's relationship with BGI, Trifunovich noted during the call that BGI is applying SmartChip TE "in a wide variety of applications. One potentially exciting project is that they would use our TE system … in multiple hospitals in China where they would prepare the sample on site, and then the amplified and prepared sample would be shipped back to BGI to a central facility for sequencing."

Trifunovich also said that "two of the three largest reference labs in the US" are currently using WaferGen's platform, and that the company is in talks with a number of CLIA labs about adopting the system.

"Our strategic goal is to make SmartChip TE the solution of choice for clinical sequencing," Trifunovich said this week. Key to that goal, he noted, was the launch of a new version of the TE product called SeqReady at the Advances in Genome Biology and Technology meeting in February. This version, he said, "greatly reduces the number of sample prep steps prior to NGS and allows for a much higher throughput than the original TE system. Therefore, we can now address both low- and high-throughput lab needs."

The most recent milestone for WaferGen was the acquisition in January of IntegenX's Apollo 324 instrument and PrepX reagents for NGS library preparation. Terms of the deal included a $2 million upfront cash payment, a three-year $1.25 million promissory note, and certain earnout payments.

Trifunovich said that the integration process following this deal has been completed, and the company now has "an effective commercial team that is ready to drive sales growth. We are also looking into opportunities for technical platform integration that would further enhance customer experience."

Trifunovich further disclosed this week that as part of the IntegenX deal, WaferGen acquired approximately $500,000 worth of inventory and production equipment, and assumed about $50,000 in liabilities. The company also gained nine employees in sales and R&D. For 2013, the Apollo product line generated $2.9 million in revenues.

"With the allocation of direct costs and operating expenses, the 2013 loss from the operation was $775,000," he added. "Because of anticipated synergies, we expect the product line to contribute positively to our operating margins in 2014."

The IntegenX deal. Trifunovich noted, gives WaferGen another tool to tackle the growing NGS market.

"It has been on the market for three years and is a market leader in the low- to medium-throughput NGS market segment with an expanding installed base," he said. "The business has shown excellent utilization of the installed base with an average pull-through of reagents and consumables in the $30,000 to $35,000 range per year."

Trifunovich also noted that Apollo 324 "is highly synergistic" with SmartChip products, especially SmartChip TE, and gives WaferGen "instant credibility in the marketplace with a significant base of recurring revenue. Serving the same customer base, the three products together address a wide spectrum of customer needs in sample preparation and validation for NGS, which gives us immediate opportunities for cross-selling."

Looking ahead, Trifunovich said that WaferGen is now eyeing the single-cell genomics market which, while burgeoning, is currently dominated by Fluidigm. He said that WaferGen believes its platform has distinct competitive advantages over Fluidigm's BioMark systems — such as affording researchers greater flexibility at less cost — although Fluidigm has a significant leg up with its C1 Single-Cell Auto Prep system for sample preparation in front of these kinds of experiments.

Summarizing, Trifunovich said that "due to a rapid growth and integration we can only provide an approximate financial outlook for the top line, which we believe will be in excess of $5 million for 2014, thus putting us on a solid growth trajectory." He also noted that the company's expected cash burn rate is $750,000 to $800,000 per month.

As WaferGen disclosed earlier this month, its full-year 2013 revenues were $1.3 million, following 2012 full-year revenues of about $586,000. Meantime, net loss in 2013 was $16.3 million, or $5.82 per share, compared to a net loss of $8.2 million, or $21.42 per share, in 2012. The company used 3 million shares to calculate its per-share figure in 2013, compared to 419,165 shares in 2012.

WaferGen attributed the increased net loss to non-cash, non-operating expenses related to a capital restructuring it initiated in the third quarter.

"In the third quarter we simplified our capital structure, which resulted in one-time non-operating charges of approximately $7.5 million; and in the fourth quarter we restructured and liquidated our Malaysian subsidiary, which resulted in one-time non-operating gains of approximately $4.4 million," Trifunovich said during this week's call. "As a result of these actions, we expect our non-operating items to be less significant in future periods."

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