Supernus reports preliminary Q2 revenue $124M, consensus $89.34M » 16:3608/1108/11/20
Preliminary Q2 net…
Preliminary Q2 net product sales of $124M increased 21% compared to the same period in 2019 due to higher net product sales of Trokendi XR and Oxtellar XR and the addition of $10.6M of net product sales from the acquisition of the CNS portfolio of U.S. WorldMeds, which closed on June 9.
|Over a month ago|
Supernus sues Apotex for infringement of Oxtellar XR patents » 18:3106/2606/26/20
Supernus Pharmaceuticals announced that it sued generic drug maker Apotex Inc. and Apotex Corp. for infringement of nine patents covering its antiepileptic drug Oxtellar XR. Supernus's United States Patent Nos. 7,722,898, 7,910,131, 8,617,600, 8,821,930, 9,119,791, 9,351,975, 9,370,525, 9,855,278, and 10,220,042 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. These nine patents do not expire until April 13, 2027. The Complaint - filed in the U.S. District Court for the District of New Jersey - alleges that Apotex infringed Supernus's Oxtellar XR patents by submitting to the U.S. FDA an Abbreviated New Drug Application seeking to market a generic version of Oxtellar XR prior to the expiration of Supernus's patents. Filing its Complaint within 45 days of receiving Apotex's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Apotex's ANDA for 30 months. Supernus has previously defended the Oxtellar XR intellectual property rights separately against two earlier generic filers; namely, Actavis and TWi Pharmaceuticals and related entities. In both cases, Supernus prevailed before the District Court as well as on appeal. Oxtellar XR is currently protected by nine patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations that expire on April 13, 2027.
Supernus upgraded to Overweight from Neutral at Piper Sandler » 06:0606/1606/16/20
Piper Sandler analyst…
Piper Sandler analyst David Amsellem upgraded Supernus Pharmaceuticals to Overweight from Neutral with a price target of $31, up from $25. The analyst's "new bullish thesis" is driven by favorable feedback from a survey of 25 movement disorder specialists focused on the company's recently acquired apomorphine products for patients with advanced Parkinson's disease. The feedback on the whole surrounding the apomorphine subcutaneous continuous infusion pump points to a relatively wide footprint for the product, Amsellem tells investors in a research note. The analyst sees an attractive risk/reward at current share levels.
Supernus granted orphan designation for Lennox-Gastaut Syndrome treatment » 16:0406/1506/15/20
Supernus Pharmaceuticals was granted FDA orphan designation for its potential treatment of Lennox-Gastaut Syndrome, according to a post to the agency's website. Reference Link
Supernus resumed with a Hold at Jefferies » 06:2306/1506/15/20
Jefferies analyst David…
Jefferies analyst David Steinberg resumed coverage of Supernus with a Hold rating and $24 price target. He is constructive on the US WorldMeds acquisition, which he said diversifies the company's revenue from Trokendi and Oxtellar, but also said the launch of unscheduled ADHD drug SPN-812 next year will be "critical."
Supernus intends to enforce Oxtellar XR intellectual property rights » 16:1905/1505/15/20
Supernus announced that…
Supernus announced that the company received a Paragraph IV Notice Letter from Apotex and Apotex Corp advising Supernus of the submission by Apotex of an abbreviated new drug application to the FDA seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this notice letter and intends to enforce its intellectual property rights relating to Oxtellar XR. Supernus has previously defended the Oxtellar XR IPR against two earlier generic filers; namely, Actavis and Twi Pharmaceuticals and related entities. In both cases, Supernus prevailed before the district court as well as on appeal. Oxtellar XR is currently protected by nine patents listed in the FDA's Orange Book that expire no earlier than 2027.
|Over a quarter ago|
Supernus delays filing of quarterly report » 14:1805/1205/12/20
In a regulatory filing,…
In a regulatory filing, Supernus Pharmaceuticals reported that it is unable to file, without unreasonable effort and expense, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. The company requires additional time to complete additional documentation regarding the change in estimate on product returns and therefore for the company's independent registered public accounting firm to complete their review procedures on the Form 10-Q. The company does not anticipate any changes to the financial results attached to the Form 8-K filed with the Securities and Exchange Commission on May 7, Supernus noted. It is anticipated that the Form 10-Q will be filed on or before the 5th calendar day following the prescribed due date of the Form 10-Q, the company said.
Supernus suspends FY20 guidance » 18:4805/0505/05/20
Given the uncertainty…
Given the uncertainty caused by the COVID-19 pandemic, the anticipated second quarter acquisition of the CNS portfolio from US WorldMeds and the impact of the partnership with Navitor Pharmaceuticals, the company is suspending its previously issued full year 2020 financial guidance. The company expects to update and reinstate full year 2020 guidance no later than the announcement of second quarter 2020 financial results in August.
Supernus reports Q1 EPS 40c, consensus 28c » 18:4805/0505/05/20
Reports Q1 revenue…
Reports Q1 revenue $95.0M, consensus $83.48M. As of March 31, 2020, the company had $935.6 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. This decrease was primarily attributable to unrealized losses on long term marketable securities resultant from market volatility in the first quarter of 2020.
Supernus price target raised to $25 from $17 at Piper Sandler » 06:1204/3004/30/20
Piper Sandler analyst…
Piper Sandler analyst David Amsellem raised the firm's price target on Supernus Pharmaceuticals to $25 from $17 and keeps a Neutral rating on the shares after publishing pro forma estimates in the wake of the acquisition of WorldMeds' central nervous system assets. The analyst believes "some multiple recovery" is appropriate, but the uncertainty over the longer-term trajectory of EBITDA does keep him cautious.