Myriad buys predictive breast cancer Dx startup Sividon for up to €50M

Myriad Genetics ($MYGN) has acquired Siemens ($SIE) spinout Sividon Diagnostics for €35 million ($39.1 million) up front with the potential for €15 million ($16.8 million) in performance-based milestones. The pair were already partners under a 2014 European marketing deal; Myriad snapped up the startup as it started to gain traction on reimbursement for its prognostic EndoPredict breast cancer test.

It plans to launch Sividon's EndoPredict test, which determines which breast cancer patients can safely opt out of chemotherapy, in the U.S. during the second half of its next fiscal year via its 150-person U.S. oncology sales force.

Myriad anticipates about $8 million in revenue in fiscal 2017 from the Sividon purchase. Myriad is funding the deal with its existing cash; it had $286 million in cash at the end of its fiscal third quarter.

"This acquisition meets all of the strategic criteria we have established for attractive assets. First, this product is synergistic with our 4-in-6 strategy and allows us to leverage our substantial oncology sales channel on a global basis," said Myriad President and CEO Mark Capone on a conference call about the deal.

The 4-in-6 strategy entails addressing four clinical questions in 6 medical specialties: What's my risk of disease? Do I have a disease? How aggressive is my disease? And how should I treat my disease?

"Second, the breast cancer prognostic market is a significant market opportunity, and EndoPredict is well positioned to gain market share as global reimbursement expands over time. Third, we believe this is a best-in-class product with substantial clinical utility over the market-leading first generation test," Capone concluded. "Lastly, the addition of a leading breast prognostic to our portfolio moves Myriad further towards becoming a comprehensive service provider in the oncology space."

Myriad is aggressively anticipating a more than $600 million market opportunity for EndoPredict, which is said is based on penetration of less than 25% globally.

Myriad is in the midst of shifting to a kit-based strategy across multiple products, including EndoPredict. It obviates the need for a laboratory-based business model as the kits run in hospital-owned labs on Thermo Fisher's ($TMO) QuantStudio instrument. Myriad is developing kit-based versions of 5 RNA-based tests: EndoPredict, Prolaris, myPath Melanoma, my Plan Lung Cancer and my Plan Renal Cancer. It has already submitted to obtain a CE mark for EndoPredict on QuantStudio.

Myriad and Sividon had already made some progress on reimbursement for EndoPredict, but Myriad hopes to push that much further.

"We foresee a significant expansion in reimbursement coverage for EndoPredict over the next several years in large markets including major European countries, Canada, and the United States," Capone said. "Sividon, in combination with Myriad, has made substantial progress over the last few years in advancing reimbursement."

He added: "In the United States, Aetna, one of the largest commercial insurers, recently published a favorable coverage determination for EndoPredict based upon the recently-issued ASCO guidelines. In addition, in the last month, the MolDX Program under Palmetto and Meridian, our Medicare administrative contractor, proposed coverage for EndoPredict based upon these ASCO guidelines."

The deal has already closed and Myriad expects the deal to be neutral to revenue and earnings in fiscal 2017.

- here is the announcement