Thoratec Corp. THOR reported second-quarter 2015 adjusted earnings of 25 cents per share (including share-based compensation), which outpaced the Zacks Consensus Estimate of 14 cents but declined 13.8% on a year-over-year basis, primarily due to higher operating expenses.
The Quarter in Details
Product sales increased 9% on a year-over-year basis to $128.7 million, which steered past the Zacks Consensus Estimate of $115 million. The upside may be attributed to better performance from the HeartMate product line.
Geographically, revenues from the U.S. increased 10.7% to $104.3 million while the same from international business increased 2.1% to $24.4 million. In Europe, Thoratec reported revenue growth of 20% on a constant currency basis.
Revenues from the flagship HeartMate product line grew 11.5% year over year to $113.7 million. During the quarter, the company sold 1035 HeartMate pumps worldwide, highlighting an impressive 20% increase from the year-ago quarter. This is inclusive of 31 HeartMate III units, which were implanted during the course of the MOMENTUM 3 U.S. clinical trial.
Thoratec witnessed increased worldwide market growth rate for chronic MCS pumps of about 18%. Implant rates began to mount in Japan in the second quarter, as the company sold 15 units in the region.
Revenues from the CentriMag business rose 2.3% year over year to $13.4 million. Robust worldwide volume growth of CentriMag was partially offset by lower revenues generated by non-pump products in this segment.
Revenues from PVAD and IVAD tumbled 68% to $0.8 million in the quarter, while revenues from Other business surged 60% to $0.8 million.
Adjusted gross margin (including share-based compensation) contracted 240 basis points (bps) on a year-over-year basis to 69.4%. The contraction was primarily led by manufacturing variances and an unfavorable foreign exchange rate.
Adjusted operating expenses spiked 22.2% year over year to $70 million owing to higher clinical trial expenses, and increased personnel costs. As a result, adjusted operating margin contracted to 15% in the reported quarter from 32.4% in the year-ago quarter.
Financial Details
Thoratec had cash and investments of $278.2 million as of Jul 4, 2015, up from $244.6 million as of Apr 4, 2015. Thoratec bought back stock worth $4.8 million during the reported quarter. However, the company has discontinued share repurchase activity in the wake of its potential acquisition by St. Jude Medical.
Product/Trial Update
Thoratec passed the six-month follow-up period for every patient enrolled in the CE Mark trial for HeartMate III and subsequently, the company submitted data to the authorized body for CE Mark in early July.
Additionally, the company announced the start of its HeartMate III less invasive surgical study in Europe. The much-awaited CE Mark approval and subsequent European launch (expected in the fourth quarter of 2015) is deemed a key growth driver for the company. Thoratec is also making significant progress with HeartMate III in the U.S. The IDE trial known as MOMENTUM 3 has enrolled a sum of 138 patients so far in the year.
Thoratec also received a conditional approval from the Food and Drug Administration (FDA) for a U.S. IDE clinical trial associated with its HeartMate PHP product. A final approval is expected in the coming months after the completion of routine formalities.
The clinical trial – SHIELD II – will be aimed at exploring use of the HeartMate PHP acute catheter-based heart pump in patients undergoing high risk percutaneous coronary intervention (PCI). It will randomize up to 425 patients at about 60 sites across the country.
HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The expandable catheter technology of HeartMate PHP can generate average blood flow of four to five liters in a minute.
Although the conditional approval has paved way for immediate start of the trial, enrollment is likely to commence in the third quarter of 2015, after site selection and training. Outside the U.S., Thoratec expects CE Mark approval for HeartMate PHP, also during the third quarter.
Our Take
2015 is anticipated to be a transition year for Thoratec as it seeks to reaccelerate growth. Positive clinical data from the HeartMate III study and the eventual European launch are likely to work wonders for the company’s overall results. However, unfavorable foreign exchange remains a headwind.
Zacks Rank
Currently, Thoratec has a Zacks Rank #3 (Hold). Better ranked stocks in the medical sector are Agios Pharmaceuticals AGIO, NuVasive NUVA and Abaxis ABAX. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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