Get All Access for FREEMarket News & Research,
Live Transcripts & Audio,
and a whole lot more…
Pharmaceutical company $AKRX said it has received a notice from the Nasdaq Listing Qualifications Staff stating that the company is not in compliance with Nasdaq's rule on timely filing of its 2015 Form 10-K with the SEC by Feb. 29, 2016. $AKRX expects to file the report with the SEC by the May 9 extension granted by the Nasdaq Stock Market.
Specialty generic pharmaceutical company $AKRX said that its shareholders have voted to approve the merger for the acquisition of Akorn by Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA. The companies expect the acquisition to close by early 2018.
$AKRX is in discussions with Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA, concerning a potential acquisition of $AKRX. A formal agreement with respect to a transaction remains subject to the approval of the board of directors of both companies. There can be no assurance any transaction will result from these discussions.
$AKRX received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil for Injection, USP, 500 mg/vial. This is the first new product approval received out of $AKRX's Decatur, Illinois manufacturing facility since the FDA re-inspection in December 2016.
$AKRX expects 2017 revenue of $1.01-1.06Bil, net income of $124-148MM, and EPS of $0.99-1.18. $AKRX sees adjusted net income of $191-215MM and adjusted EPS of $1.53-1.72. $AKRX sees adjusted EBITDA of $363-401MM, operating cash flow of $250-275MM, capital expenditures of $70-90MM and diluted shares outstanding of 125MM.
$AKRX reported a decline in 4Q16 earnings due to higher costs and expenses. Net income slid to $32.46MM or $0.26 per share from $32.79MM or $0.27 per share last year. Revenue grew to $283.67MM from $279.98MM. Adjusted EPS decreased to $0.58 from $0.60.
$AKRX said the US FDA conducted a re-inspection of its Decatur, Illinois manufacturing facility from December 5, 2016 to December 9, 2016, with no Form 483 observations. The re-inspection was conducted to verify the implementation and effectiveness of $AKRX’s responses to the observations from the June 2016 FDA inspection.
$AKRX launched prescription version of Ibuprofen 100mg/5mL oral suspension in 118mL and 473mL bottles as well as 5mL unit dose cups. For children, ibuprofen oral suspension is indicated for reduction of fever, mild to moderate pain and juvenile arthritis. For adults, it will treat primary dysmenorrhea, and rheumatoid arthritis and osteoarthritis.
$AKRX said it filed quarterly reports on Forms 10-Q with the Securities and Exchange Commission (SEC) for the quarters ended March 31, 2015, June 30, 2015 and Sept. 30, 2015. The results that are included in the individual Forms 10-Q were previously filed in its comprehensive Form 10-K for FY15 that was filed with the SEC on May 10.
Matt Hewitt of Craig-Hallum asks about target action and PDUFA dates over the course of the year. $AKRX CEO Raj Rai said the company has about 38 GDUFA/target action dates on its filings. All the recent filings that it has made in the six months, the company has received a GDUFA date.
David Steinberg of Jefferies asks whether there is any disruption in the market from the Valeant-Walgreens deal in the ophthalmic area. CEO Raj Rai said $AKRX has not seen any disruption in its ophthalmic products. He said his understanding is that Valeant is trying to sell their branded products as generics with the same kind of pricing.
Louise Chen of Guggenheim asks how much growth came from price versus volume in 1Q16. $AKRX CFO Duane Portwood replied from a price-volume perspective for the quarter, volume accounted for about 37.4% of the growth and price was a little over 60%.
$AKRX said it expects its net debt to adjusted EBITDA ratio to be close to 1.0 times at the end of 2016, absent a large acquisition or debt issuance. The company added that its 2016 guidance includes net revenue range from $1.60-1.80MM, diluted GAAP EPS of $1.56-1.66 and diluted non-GAAP EPS of $2.10-2.20.
Pharma company $AKRX said tax rate for 1Q16 was 37.1% and it expects the full year 2016 income tax rate to be approx. 37%. The company ended 1Q16 with $141MM in cash compared to $346MM at Dec. 31, 2015. $AKRX made a voluntary prepayment of $200MM against its term loan facility, leaving it approx. $832MM outstanding against its term loan facility.
$AKRX said it is focused on replenishing its ANDA pipeline and anticipates filing approx. 20 new filings in 2016. The company is in the process of expanding is R&D footprint by expanding its current facilities and adding a new R&D facility in the New Jersey pharma corridor.
Lake Forest, Illinois-based $AKRX said it expects to see sequential revenue growth in 2Q16 as a result of the recent contract awards, including large customer RFPs. Since Dec. 2015, the company has launched five new products, which are already factored into its guidance.
$AKRX said, at March 31, it had 86 ANDAs pending at the FDA, representing approx. $9.2Bil in annual branded and generic market value according to IMS Health. Akorn has over 72 additional ANDAs in various stages of development, representing approx. $12.8Bil in annual branded and generic market value.
$AKRX CEO Raj Rai commented on 1Q16 performance: "We are off to a good start to 2016. In the first quarter, we realized a solid organic growth from our portfolio and since December, we have launched five new products. With the restatement behind us, we are now focused on accomplishing our objectives set forth for 2016..."
Specialty generic pharmaceutical company $AKRX reported higher 1Q16 results, helped in part by portfolio growth, and maintained its 2016 outlook. The company reported 1Q16 earnings of $42MM, or $0.34 per share, compared to $38MM, or $0.31 per share a year ago. Revenue rose 18% to $268MM.