Alere Continues Executing And Building Credibility
Alpha Gen Capital
Alpha Gen Capital
Alere Executing On Its Transition To A Focused Portfolio Of Assets
Alpha Gen Capital
Alpha Gen Capital
Yesterday, 11:47 AM
- Abbott's (ABT +0.4%) wobbly deal to acquire point-of-care diagnostics outfit Alere (ALR -1.9%) just got nastier. Yesterday, the Waltham, MA-based firm filed a complaint in Delaware Chancery Court aiming to force Abbott to go through with its $56/share offer ($5.8B) announced earlier this year. Abbott is trying to back out of the transaction because it has lost confidence in the robustness of Alere's internal controls. In April, Abbott reportedly offered Alere $50M to call it off, an offer it rejected.
- Five months after Abbott announced the intended takeover, Alere disclosed that it would need to restate its annual financial statements for the years 2013, 2014 and 2015, in addition to two interim reports for 2015, due to revenue recognition issues in certain ex-U.S. markets. It also stated that it expected to report one or more material weaknesses in its disclosure controls and procedures and its internal control over financial reporting.
- A short time later, the news broke that Alere was being investigated by the U.S. Department of Justice over its government billing practices in its toxicology unit, specifically the offering of inducements to doctors to order its tests. The Feds regard these activities as illegal kickbacks.
- Previously: Alere almost there with 2015 10-K filing; analysts say Abbott deal on track; ALR shares up 8% (July 15)
- Previously: Alere in Feds' crosshairs over billing practices as woes mount; Abbott deal on the rocks; shares slump 30% at close (July 27)
Fri, Aug. 19, 7:53 AM
- Alere (NYSE:ALR) receives 501(k) clearance for its Alere i RSV test, a rapid point-of-care molecular diagnostic assay that can detect RSV in no more than 13 minutes. The product is the third approved test in its i platform (Strep A and Influenza A&B).
- The company intends to apply for a CLIA waiver shortly which will allow non-laboratory technology-trained personnel to perform the test. The FDA extends the designations to labs that perform simple assays that present little risk of error.
Wed, Aug. 17, 6:49 AM
Wed, Aug. 17, 6:26 AM
Fri, Aug. 12, 8:04 AM
- TeamHealth Holdings (NYSE:TMH) upgraded to Buy from Hold with a $52 (41% upside) price target by Jefferies.
- Editas Medicine (NASDAQ:EDIT) upgraded to Buy from Hold with a $35 (69% upside) price target by Jefferies.
- ZIOPHARM Oncology (NASDAQ:ZIOP) upgraded to Market Perform from Underperform by Wells Fargo. Target price range: $5 - 8 (25% upside from midpoint).
- Bellicum Pharmaceuticals (NASDAQ:BLCM) upgraded to Buy from Neutral with a $24 (22% upside) price target by Citigroup.
- Alere (NYSE:ALR) upgraded to Buy from Neutral with a $48 (20% upside) price target by BTIG Research.
- Merck (NYSE:MRK) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $73 (15% upside) from $62. Upgraded to Outperform from Market Perform by BMO Capital. Price target raised to $72 (13% upside) from $62.
- Celgene (NASDAQ:CELG) upgraded to Buy from Neutral with a $138 (21% upside) price target by BTIG Research.
- Bristol-Myers Squibb (NYSE:BMY) downgraded to Hold from Buy by Berenberg. Price target lowered to $70 (15% upside) from $80. Downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $63 (3% upside) from $86.
- Zosano Pharma (NASDAQ:ZSAN) downgraded to Neutral from Buy by Ladenburg Thalmann.
- Myriad Genetics (NASDAQ:MYGN) downgraded to Hold from Buy by Gabelli & Co. Price target lowered to $32 (54% upside) from $46.
- Ohr Pharmaceutical (NASDAQ:OHRP) downgraded to Hold from Buy by Brean Capital.
- Inovio Pharmaceuticals (NASDAQ:INO) downgraded to Hold from Buy by Maxim Group. $14 price target removed.
- Raptor Pharmaceutical (NASDAQ:RPTP) downgraded to Neutral from Buy by Citigroup. Price target raised to $8 (19% upside) from $6.
- Regeneron Pharmaceuticals (NASDAQ:REGN) downgraded to Neutral from Outperform by Baird. Price target lowered to $488 (16% upside) from $505.
Mon, Aug. 8, 10:32 AM| Mon, Aug. 8, 10:32 AM | 14 Comments
Mon, Aug. 8, 9:24 AM
Mon, Aug. 8, 6:29 AM
Thu, Jul. 28, 12:59 PM
Thu, Jul. 28, 11:00 AM
Thu, Jul. 28, 9:16 AM
- Gainers: EVOK +31%. GRPN +29%. OCN +25%. ALR +20%. N +18%. ESI +15%. TPX +15%. GRUB +13%. LOGI +13%. VSTM +12%. CRUS +11%. ASPS +11%. CHCI +11%. EBIO +11%. AXTI +11%. VNR +9%. SPHS +9%. VGZ +8%. KONA +7%. CLF +6%. ARIA 6%. SPU 5%. YNDX 5%.
- Losers: INFN -32%. ARGS -18%. AVXL -10%. IVTY -10%. F -8%. CIEN -8%. CBD -8%. XCOM -7%. EXAS -6%. WFM -5%.
Wed, Jul. 27, 5:58 PM
- The problems continue to mount for point-of-care diagnostics firm Alere (NYSE:ALR). The latest stumble is the news that U.S. Department of Justice investigators have requested information from the company about its government billing practices, specifically its toxicology unit, which provides drug testing for employers and government bodies. The business accounts for about a quarter of Alere's revenues.
- The company received a subpoena last month seeking patient billing records. Its specific area of interest is Alere's efforts to collect co-payments from patients and alleged submission of forms to government programs like Medicare on patients' behalf. Federal law prohibits healthcare firms from covering payments for patients insured under programs like Medicare and Medicaid. The feds are also looking into whether Alere made payments or provided other inducements to doctors in order to influence their ordering of its tests. The government regards these activities as illegal kickbacks. The situation has the earmarks of a whistleblower suit.
- In February, Alere agreed to be acquired by Abbott Laboratories (NYSE:ABT) for almost $6B. Since then, however, the company has faced one embarrassing snafu after another, including having to restate its financial reports due to inappropriate revenue recognition (including "bill-and-hold" activities in China) and recalling products due to safety concerns related to the potential misreporting of results.
- In April, Abbott purportedly offered to pay as much as $50M to back out of the deal, a proposal Alere's board rejected. It is a virtual certainty that Abbott will wash its hands of Alere, though. It's just a matter of price at this point.
- Shares were down 29% today, but have rebounded 7% after hours on robust volume.
- Read now A Deal Worth A Leer
- Update: In a statement, the company says the billing records of interest, dating back to 2010, are related to its Austin, TX pain management laboratory. It is fully cooperating with the inquiry. It also says the billings in question accounted for less than 1% of its revenues and the matter is "not material."
Wed, Jul. 27, 5:39 PM
Thu, Jul. 21, 9:13 AM
- The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meets today and tomorrow to review two applications for diabetes-related devices.
- Today, it will discuss Dexcom's (NASDAQ:DXCM) premarket approval application (PMA) panel-track supplement for a proposed change in the intended use of its Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM) that will allow patients to use the device as a replacement for their blood glucose meters and make treatment decisions based on the glucose concentration in the interstitial fluid reported by the CGM.
- Tomorrow, the panel will discuss Alere's (NYSE:ALR) 510(k) submission seeking clearance of its Afinion HbA1c Dx point-of-care (POC) test system, an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c) in human whole blood. Current clinical guidelines do not support POC hemoglobin tests to diagnose diabetes.
- FDA briefing doc - Dexcom
- Dexcom briefing doc
- FDA briefing doc - Alere
- FDA briefing doc appendices - Alere
- Alere briefing doc
- Panel questions - Alere
Fri, Jul. 15, 12:25 PM
- In a statement, point-of-care diagnostics firm Alere (ALR +7.6%) confirms that will restate its annual financial statements for 2013, 2014 and 2015 and interim statements for the periods ended March 31, 2015 and September 30, 2015 after identifying the specific revenue recognition issues that have delayed the filing of its 2015 reports.
- The specific areas pertaining to the timing of revenue recognition were mainly confined to Africa, where revenue was recorded when product was shipped to the distributor but the title did not transfer until the distributor paid for the products in full or the distributor was not obligated to pay the bill until the products were sold to end users.
- Another problem was "bill and hold" transactions (an invoice is generated but the product remains in inventory), principally in China (any legitimate accounting firm will consider this a significant "no-no").
- There were other unspecified transactions where Alere recognized revenue prior to satisfying all the contractual criteria for the transfer of title and risk to the customer.
- The company says the revisions will not be material since they do not impact the total amount of recorded revenue other than the change brought about by establishing a returns allowance for its Indian subsidiary. It plans to file its 2015 financials as soon as feasible, followed by its Q1 2016 10-Q. It admits that it expects to report one or more material weaknesses in its disclosure controls and procedures and internal control over financial reporting.
- On a preliminary basis, revenue ($M) for 2015 and Q1 2016 will be $2,447 - 2477 and $573 - 593, respectively. Net income will be $10 - 25 and $(8) - 2, respectively, and non-GAAP EBITDA $505 - 520 and $106 - 116.
- Analysts expect the $5.8B takeover by Abbott Laboratories (ABT -0.4%) to proceed.
Tue, Jul. 12, 8:01 AM
- Following a collaborative process with the FDA, point-of-care diagnostic firm Alere (NYSE:ALR) will be initiating a voluntary withdrawal of its Alere INRatio and INRatio2 PT/INR Monitoring System.
- In December 2014, the company initiated a voluntary correction to inform users of the device that patients with certain medical conditions should not be tested with the product due to the potential misreporting of results. Over the past two years, Alere updated the software to address the issue. At the end of 2015, the FDA notified the company that it did not agree that the problem was fixed and advised the company to submit a plan for the voluntary removal of INRatio from the market.
- Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.
- Related ticker: (NYSE:ABT)
Alere, Inc. develops, manufactures and markets consumer and professional medical diagnostic products. The company's products and services focus on cardiology, infectious disease, women's health, oncology, and toxicology. Its portfolio also includes a broad array of health information solutions... More
Industry: Medical Laboratories & Research
Country: United States