UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

April 30, 2015

 

 

Pacific Biosciences of California, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

1380 Willow Road

Menlo Park, California 94025

(Address of principal executive offices, including zip code)

(650) 521-8000

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):

 

 

 

 

 

 

 

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As previously disclosed, on September 23, 2013, Pacific Biosciences of California, Inc. (the “Company”) entered into a Development, Commercialization and License Agreement (the “Agreement”) with F. Hoffman-La Roche Ltd (“Roche”), pursuant to which the Company: (i) agreed to develop diagnostic products for clinical use including sequencing systems and consumables based on the Company’s proprietary Single Molecule, Real-Time (SMRT®) technology; (ii) granted Roche an exclusive right to commercialize, and an exclusive license to sell, the developed diagnostic products for clinical use, the exclusivity of which is contingent on achieving sales minimums to be established in the future and contingent on Roche not selling for clinical use any new sequencing instrument that competes with any diagnostic instrument system developed under the Agreement; and (iii) agreed to manufacture and supply certain products intended for clinical use as the exclusive supplier to Roche.   Pursuant to the Agreement, the Company received from Roche a non-refundable up-front payment of $35 million and is eligible to receive up to an additional $40 million based upon the achievement of development milestones. The Agreement has an initial term of 13 years and provisions allowing Roche 5-year renewals.

On April 30, 2015, the Company achieved the second development milestone under the Agreement, entitling the Company to receive an additional payment of $10 million from Roche. A copy of the press release containing the announcement is included as Exhibit 99.1 and is incorporated herein by reference.

 

 

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Date: May 5, 2015

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EXHIBIT INDEX

 

 

 

 

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Exhibit 99.1

 

Pacific Biosciences Achieves Second Development Milestone in Clinical Diagnostics Agreement with Roche

$10 Million Milestone Payment Brings Total Funding to Date from Roche up to $55 Million

 

MENLO PARK, Calif., – May 5, 2015 – Pacific Biosciences of California, Inc. (Nasdaq:PACB), provider of the PacBio® RS II Sequencing System, today announced that it has achieved a second development milestone under its development, commercialization and license agreement with F. Hoffman-La Roche Ltd (Roche), earning an additional $10 million.

 

The development, commercialization and license agreement with Roche covers diagnostic products for clinical use, including sequencing systems and consumables based on Pacific Biosciences’ Single Molecule, Real-Time (SMRT®) technology. Under the agreement, Roche has the exclusive right to commercialize and sell the developed diagnostic products for clinical use, subject to certain terms and conditions.

 

Pacific Biosciences received from Roche a non-refundable up-front payment of $35 million in September 2013, and was eligible to receive up to an additional $40 million based upon the achievement of development milestones. Pacific Biosciences has now earned $20 million of the $40 million potential milestone payments pursuant to the agreement.

 

“We are on track to deliver a system to Roche by the second half of next year, consistent with our original target,” said Michael Hunkapiller, President and CEO of Pacific Biosciences. “I have been very pleased to see the productive spirit of collaboration under which our companies have been working for the last 18 months, and I’m confident that we will continue our record of milestone achievement for the duration of the development project.”

 

Dan Zabrowski, Head of Sequencing and Tissue Diagnostics at Roche commented: “We are very pleased with the progress on this collaboration, and look forward to transitioning from product development to product sales in the future.  Our goal has been to accelerate the integration of DNA sequencing into routine diagnostics, and we believe we are well on our way to achieving this with PacBio.”

 

The proceeds from the development milestone will be recognized as contractual revenue in the Pacific Biosciences financial statements for the quarter ending June 30, 2015.   

 

About Pacific Biosciences
Pacific Biosciences of California, Inc. (NASDAQ: PACB) offers the PacBio®  RS II Sequencing System to help scientists resolve genetically complex problems. Based on its novel Single Molecule, Real-Time (SMRT®) technology, Pacific Biosciences’ products enable: de novo genome assembly to finish genomes in order to more fully identify, annotate and decipher genomic structures; full-length transcript analysis to improve annotations in reference genomes, characterize alternatively spliced isoforms in important gene families, and find novel genes; targeted sequencing to more comprehensively characterize genetic variations; and DNA base modification identification to help characterize epigenetic regulation and DNA damage. Pacific Biosciences’ technology provides the industry’s highest consensus accuracy over the longest read lengths in combination with the ability to detect real-time kinetic information. The PacBio RS II System, including consumables and software, provides a simple, fast, end-to-end workflow for SMRT Sequencing.  More information is available at www.pacb.com.

 

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the timeline for Pacific Biosciences’ potential development and delivery of products for Roche, the potential future commercialization of such products, future milestone achievement, the expected benefits of the agreement with Roche and other future events. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, changes in circumstances and other factors that are, in some cases, beyond Pacific Biosciences’ control and could cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Factors that could materially affect actual results can be found in Pacific Biosciences’ most recent filings with the Securities and Exchange Commission, including Pacific Biosciences’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption “Risk Factors.” Pacific Biosciences

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undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.

 

Contact:

For Pacific Biosciences:

Media:Investors:
Nicole LitchfieldTrevin Rard
415.793.6468650.521.8450
nicole@bioscribe.comir@pacificbiosciences.com

 

 

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