Alere (ALR) Reader Attains CE Mark, Submits Delayed 10K

BAX QDEL

Alere Inc. recently announced the receipt of In-Vitro Diagnostic (IVD) CE marking for its new Alere Reader. The device is a diagnostic analyzer that can be used in both point-of-care and laboratory settings.

Alere reader ensures the accuracy of the rapid test results. The device helps healthcare providers to obtain the most accurate results almost on a real-time basis, which will facilitate in administering the right treatment quickly.

The CE marking will allow Alere to market the Reader in Europe. Initially, Alere BinaxNOW Legionella and Streptococcus pneumoniae antigen cards will be available with the device. The company plans to launch additional assays for the detection of respiratory and healthcare associated infections over the next 6-12 months.

Meanwhile, Alere recently reported its fourth quarter and fiscal 2015 results and filed 10K with the SEC. The late filing included revisions of revenue figures dating back to 2013, which the company stated as “immaterial”.

Among the notables, Alere acknowledged additional income tax expense of $8 million in 2015 (nine months) and a reduction in income tax expense of $7 million in 2014 related to the timing of recognition of certain tax-specific items.

These tax-related revisions resulted in a decrease of 9 cents in basic & diluted earnings in 2015 (nine months results) and an increase of 7 cents in 2014.  However, none of these revisions affected Alere’s cash flow or cash balances.

In full-year 2015, Alere reported loss of 40 cents per share much narrower than $2.33 reported in full-year 2014. Revenues declined 4.3% to $2.46 billion.

Quarter Details

Revenues declined 6.6% year over year to $623 million. Unfavorable foreign exchange rate impacted revenues by $26 million. Organic growth was flat in the reported quarter.

 

Loss was 28 cents per share as compared with 43 cents per share in the year-ago quarter.  The company recorded $43 million in pre-tax expenses ($30 million after tax) related to its previously announced voluntary INRatio product withdrawal.

Adjusted EBITDA was $95 million as compared with $127 million reported in the year-ago quarter.

Key Picks

Well-placed stocks in the medical sector are NuVasive , Quidel (QDEL - Free Report) and Baxter International (BAX - Free Report) . While NuVasive and Quidel sport a Zacks Rank #1 (Strong Buy), Baxter has a Zacks Rank #2 (Buy).

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