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RainDance to Use $35M Financing to Support Burgeoning Digital PCR Business as it Mulls IPO Option

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RainDance Technologies said this week that it has closed a structured debt financing with Capital Royalty Partners, providing it with up to $35 million to support the commercial expansion of its digital PCR and targeted DNA sequencing products.

RainDance will specifically use the financing to fuel additional growth of its digital PCR business, revenues from which the company anticipates will match or even surpass that of its targeted sequencing business by the end of 2014 — even though the targeted sequencing business is a year and a half older, CEO Roopom Banerjee told PCR Insider this week.

In addition, considering its growth trajectory and given some recent successes in the space, RainDance is for the first time "seriously entertaining" the idea of an IPO or grooming itself as an acquisition target for a larger biotech tools provider, Banerjee said.

RainDance has parlayed its core picoliter droplet reagent packaging technology into two primary businesses, targeted sequencing and digital PCR. Within targeted sequencing, RainDance offers the RDT 1000 for low- to medium-throughput applications, and the newer ThunderStorm for higher-throughput applications. Both systems are compatible with all the major next-generation sequencing platforms currently on the market.

Meantime, the company's flagship digital PCR system is the RainDrop, which RainDance began placing with early-access users in early 2012 (PCR Insider 3/29/2012), and which it officially began selling in March of this year (PCR Insider 1/17/2013).

Both the targeted sequencing and digital PCR applications rely on the picodroplet technology for their high level of sensitivity and speed, and low cost per sample compared to competing products, and RainDance has relatively quickly carved out significant market share for itself in both arenas.

Targeted sequencing currently accounts for the majority of RainDance's revenues, but digital PCR is quickly closing the gap, Banerjee said.

"Digital PCR just launched about six months ago, while targeted sequencing has been in the market with Thunderstorm for about a year and a half," he said. "Within the next two years we'll continue to see strong growth within both those businesses … but we anticipate that by the end of next year, digital PCR will have caught up with and possibly outpaced the growth within targeted sequencing."

Underscoring this point, Banerjee said that RainDance will have sold twice as many RainDrop systems this year than originally forecast, in only nine months. This rapid uptake, he added, is a major reason the company decided to pursue the debt financing with Capital Royalty Partners.

"We are growing the digital PCR franchise at breakneck speed right now," Banerjee said. "With a very small sales force we've already started taking quite important market share. We have benefitted dramatically from the level of market education awareness that players like Bio-Rad and Life [Technologies] are creating."

Bio-Rad is RainDance's main competitor in the digital PCR space, primarily because its QX100 Droplet Digital system also uses a droplet-based technology to enable many of the same applications — namely, rare allele detection and copy number variation analysis — as the RainDrop.

"We are selling head-to-head particularly against Bio-Rad," Banerjee said. "We haven't seen Life Tech as a competitor yet in the market in a meaningful way. That may be a function of the fact that its system is limited in its capabilities … [and] the workflow is very limited."

Banerjee conceded that Bio-Rad's "very large sales force and infrastructure continues to make it the largest player in the digital PCR market. They also had a lead to market, having launched almost two years prior to us. That said, we are gaining share actively from all the players in the market right now. We are winning accounts at an extremely high rate … and importantly we've had no competitive losses in head-to-head bakeoffs against the other players."

RainDance's "only barrier to growth" in digital PCR, Banerjee said, is the size of its sales force and limited infrastructure available to support growth and manufacturing. To help rectify that situation, the company recently moved its headquarters from Lexington, Mass., a few miles down the road to new digs in Billerica, Mass., doubling its space and tripling its manufacturing capabilities.

Further, RainDance plans to double the size of its sales team over the next six months and expand its service and support capabilities, Banerjee said.

RainDance will also invest heavily in developing new digital PCR applications. "Customers will continue to see a broad range of applications across cancer, viral load quantitation, as well as pathogen detection, in addition to a whole host of research capabilities in areas like immune monitoring, cardiology, stem cell research, and even outside of human health care in [agricultural biology] and production genomics, which includes the industrial food testing and pharmaceutical market," Banerjee said.

Several independent research groups are already pushing these and other new applications to the fore, taking advantage of RainDrop's ability to generate an unprecedented number of droplets, or individual PCR reaction volumes, which is essential to achieving a high degree of sensitivity and precision in digital PCR. Additional advantages of the RainDrop system, Banerjee said, are its multiplexing ability, closed architecture (thus reducing contamination concerns), and turnkey operation.

"From a translational perspective, there is some really exciting data coming out of some of the cancer centers," Banerjee said. For instance, in July researchers from Massachusetts General Hospital published a paper demonstrated how RainDrop could be used to detect mutations associated with glioblastoma brain tumors in RNA extracted from extracellular vesicles released from the tumors into patients' cerebrospinal fluid (PCR Insider 8/1/2013).

And in August researchers from RainDance, Université Paris Sorbonne Cité, University of Strasbourg, and other French institutions published a paper in Clinical Chemistry demonstrating that using RainDrop to detect KRAS mutations in circulating tumor DNA directly from blood samples yielded equivalent or better specificity and sensitivity than qPCR or sequencing directly from biopsy tissue.

Another win for RainDance was the recent disclosure by Trovagene that it had started using the RainDrop system to develop and eventually run a cell-free transrenal BRAF mutation assay out of ita CLIA lab, after having previously worked with Bio-Rad's digital PCR platform (PCR Insider 8/1/2013).

"We're in the early innings of a very big opportunity in digital PCR, and we have a unique position in terms of performance, capability, and applications versus the rest of the market," Banerjee said.

Other investments

RainDance's growth in the digital PCR space is not making the company forget about the business that got it to this point — targeted sequencing.

The competitive landscape here, Banerjee said, hasn't changed much in the past few years. "It continues to be Illumina's TruSeq product, IonTorrent with its AmpliSeq product, and Agilent, which has a portfolio of products between SureSelect and HaloPlex," he said. "In terms of our direct competitors, we tend to see Illumina most often, primarily because they tend to have a greater focus on CLIA labs and clinical customers, in terms of their market focus. Agilent and Roche Nimblegen, and Fluidigm, have done a nice job with the research market, but have not really turned towards the CLIA lab market yet."

To wit, RainDance closed a $20 million Series E equity financing in April that included Myriad Genetics as a strategic investor. RainDance and Myriad also in April signed an agreement under which RainDrop is providing Myriad with its ThunderStorm target enrichment platform and related consumables for use in Myriad's myRisk sequencing-based hereditary cancer panel.

"We have the best analytical performance, workflow, and cost, and importantly we make sequencing cheaper for all our customers," Banerjee said. "When you look at the entire workflow, we help customers achieve some of the lowest cost per sample in the industry. You can certainly see that validated through our relationships with customers like Myriad, Ambry, and GeneDx, among others. Further, academic customers such as Memorial Sloan-Kettering Cancer Center are developing next-generation sequencing-based cancer panels using RainDance's system in combination with a variety of sequencing platforms.

RainDance will use some of the Capital Royalty Partners financing, then, to also build out its sales and marketing infrastructure, scale up manufacturing capabilities, and develop new applications in targeted sequencing.

"What's most compelling, and part of the reason [Capital Royalty Partners] made the investment here, is that we've demonstrated a substantially higher level of [consumables] pull-through per instrument in the customer base that we're targeting within the targeted sequencing franchise — orders that are many multiples of what Fluidigm and Nanostring are getting in terms of pull-through from their customers … and also significantly higher than what Illumina is pulling through on its HiSeq instrument. So we've got a very rare and unique business model that is driven by high-margin consumables off a small instrument base in the targeted sequencing community."

Banerjee declined to quantify that pull-through, but said that the numbers are "pretty remarkable and frankly unprecedented in this industry," and that the company plans to provide more granularity on these figures at upcoming investor conferences.

Overall, growth in RainDance's two main businesses has caused the company to "rapidly outgrow our own growth expectations," Banerjee said. By the end of this year the company will have approximately doubled its revenues from the prior year to just shy of $20 million. "And we have very good visibility into 2014 where we expect anywhere between a 50 to 100 percent increase in revenues," he added.

As such, for the first time the company is "more seriously entertaining" the notion of an IPO or positioning itself as an acquisition target for a larger company.

"We've been very fortunate … to have had a number of strategic partnering and acquisition opportunities over the years," Banerjee said. "We've decided for a variety of reasons – mostly due to confidence in our own execution capabilities – to go it on our own."

He added that RainDance is "intrigued and encouraged" by recent IPO successes in the biotech tools space, and is also "intently watching the IPO backlog."

"We certainly see RainDance as a company that either could be a public company or would fit great in a larger portfolio or channel in one of the larger companies," Banerjee said.

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