BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Continues Higher

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has had two days of substantial gains and seems to have triggered a sell program as shares met significant resistance at $2.85. Last Thursday, Friday, and Monday BDSI shares had a tough time breaking above $2.30 then yesterday shares moved up steadily only to meet some mild resistance at $2.60. Today shares gapped up to open at $2.75 and quickly climbed to $2.85 by mid-day but, apparently, strong selling kicked in and BDSI was unable to sustain any moves above $2.85 and closed today at $2.75. Volumes were heavy. Over 2.2 million shares of BDSI traded today or about three times their 30-day, daily average trading volume of 613,500.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)’s development strategy focuses on the utilization of the FDA’s 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.

Today, upward movement was likely helped along by the company’s announcement that it has signed an agreement with CVS/Caremark extending access to both BELBUCA® (buprenorphine) buccal film (CIII) and BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) through 2020. The agreement is important as CVS/Caremark represents a significant portion of the covered lives in the United States. BioDelivery Sciences International, Inc. (NASDAQ:BDSI) reacquired BELBUCA from Endo Pharmaceuticals in January 2017 and subsequently relaunched the product. Prescription sales for BELBUCA reached their highest point in May 2017 since the product was launched by Endo in early 2016 and continues to grow in June. Weekly sales for BELBUCA for the week ending June 9, 2017 (1,657 prescriptions) exceeded the previous peak from December 2016 for the first time according to data from Symphony Health.

Shares of BioDelivery Sciences International, Inc. (NASDAQ:BDSI) have performed well over every timeframe. In the past week, BDSI shares gained over 14%, they are up over 6% for the month, up over 48% YTD, and up over 10% for the year. Seven investment firms follow BDSI shares. Six rate them as a “Strong Buy” and one rates them as “Hold” Their consensus price target is $4.00.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $BDSI and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Re-acquires Belbuca

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has been on an upward trend after reporting Q1 2017 earnings that beat estimates. Reacquisition of license rights to pain the management product, Belbuca, continues to fuel investor’s sentiments on the stock.

Stellar Q1 Earnings

The pain management product remains a key driver of the company’s earnings. During the first quarter, the drug generated sales that propelled BioDelivery Sciences International, Inc. (NASDAQ:BDSI) to profitability. First quarter net income came in at $48.3 million or $0.58 cents a share, blowing away analysts’ earnings expectations of $0.09 cents a share.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Chief Executive Officer, Mark Sirgo, expects revenue and earnings growth to continue into the second half of the year.

“We completed a swift and effective transition of BELBUCA following the early January close of the transaction with Endo Pharmaceuticals (Endo), and by the end of the quarter, we were generating sufficient product revenue to offset the expense of our commercial business unit. In fact, we recorded the highest net sales revenue for BELBUCA since the product was launched over a year ago…,” said Mr. Sirgo.

BioDelivery Sciences reported net revenues of $29.5 million for the first quarter, compared to net revenue of $3 million reported last year. Belbuca accounted for $4.6 million of total revenues. The company would have earned $640,000 in royalty payments from the drug had it not reacquired it. Cash and cash equivalent as of the end of the first quarter totaled $35.2 million compared to $32 million as of December 31, 2016.

Growth Drivers

The specialty pharmaceutical company is currently pursuing licensing agreements for Belbuca as it continues to pursue new sales avenues. The company is also eyeing approval in Canada to supplement sales in the U.S. Early this year the company secured $75 million in financing that it plans to use for the commercialization of the drug.

Belbuca is not the only product that BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is relying on for revenues. Bunavail is the company’s other lead product and it generated revenues of $3.2 million in the quarter, up from $2.1 million as of last year.

“As for BUNAVAIL®, we will continue to focus our efforts on our current prescribers while working to secure new managed contracts where BUNAVAIL is in a favorable position. BUNAVAIL generated $3.2 million in revenue for the quarter,” said Mr. Sirgo.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) plans to make a regulatory submission later in the year for the manufacture of ONSOLIs, a drug it licensed to Collegium Pharmaceuticals in 2016

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) closed a $2.30 on volume of 213,882.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $BDSI and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Tweaks Sales Structure Ahead Of Q1 2017 Earnings

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is set to announce financial results for the first three months of the year on May 15, 2017. The company is fresh from filing Form 12b-25 with the U.S Securities and Exchange Commission in which it asked for five extra days for the completion of an audit report with regards to termination of its license report with Endo.

Sales Channel Restructuring

When the biopharmaceutical reports its financial results, at stake will be the performance of its key product Belbuca for the treatment of back pain. Sales for the opioid dependence treatment Bunavail have been lackluster in the recent past and it will interesting to see if they improved in Q1 2017.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has been working behind the scenes as it looks to improve sales for its key products. Reduction of sales force has already come into focus, the company has reduced the number of sales territories in which it operates.

However, the company has sought to focus on growth-oriented territories even with the restructuring push. BioDelivery has also sought to secure new managed care contacts on either an exclusive or preferred status. The company has started running a direct-to-patient digital advertising campaign in four cities as it looks to accelerate sales growth.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) expects Bunavail to generate a substantial amount of profit going forward given the reduced cost structure in place as well as growth opportunities at stake. The Food and Drug’s Administration recently approved the drug’s usage as a buprenorphine treatment for opioid dependence.

Pipeline Update

“The approval broadens the indication for BUNAVAIL to include induction, or the initial process undertaken when a patient is transitioned from the abused opioid responsible for their addiction to the dose of BUNAVAIL which is intended to provide relief from cravings and withdrawal. Induction is the first step to assist a patient in discontinuing or markedly reducing their use of other opioids,” said the company in a press release.

The expansion should go a long way in making Bunavail highly competitive in the market giving sales representatives the much-needed leverage for communicating its benefits in the treatment of Opioid dependence.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has underperformed the market over the past 12 months having risen by 2.8% compared to the industry average of 3.9%. Missing earnings estimates in two of the last four quarters have not helped the stock’s sentiments among investors. However, the company beating consensus estimates with the upcoming earnings report could help bolster investor sentiment.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) stock was unchanged in Friday trading session ending the week at $1.90 a share.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Surges On Q1 Net Profit

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) edged higher in the market after reporting Q1 2017 earnings that beat Wall Street expectations. The North Carolina-based company says it generated a net income of $48.3 million in the quarter compared to a net loss of -$18.7 million the same period last year.

Q1 Financial Results

BioDelivery Sciences International, Inc. (NASDAQ:BDSI)’s net profit in the quarter was mostly driven by an increase in sales of the company’s key products BELBUCA and BUNAVAIL. The company has also attributed the increase to a licensing and distribution agreement for Belbuca.

Net revenue in the quarter totaled $29.5 million. Product related revenue came in at $9.5 million compared to $3.3 million as of Q4 2016. BELBUCA net sales came in at $4.6 million as Bunavail sales nearly doubled to highs of $3.2 million from $2.1 million as of the first quarter last year.

Operating expenses in the quarter dropped to $15.9 million from $18.4 million mainly as a result of a reduction in operating expenses in relation to research and development spending. Cash and cash equivalents as of the end of the quarter totaled $35.2 million.

“We completed a swift and effective transition of BELBUCA following the early January close of the transaction with Endo Pharmaceuticals (Endo), and by the end of the quarter, we were generating sufficient product revenue to offset the expense of our commercial business unit,” said Chief executive officer Dr. Mark A Sirgo.

Corporate Highlights

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) has since confirmed it is pursuing licensing agreements as it seeks to secure two partnerships in the U.S for BELBUCA. Focusing on current prescribers for BUNAVAIL is a core objective as the company looks to secure new managed contracts where the drug is in a favorable position.

Some of the milestones achieved in the quarter included the closing of an agreement with Endo Pharmaceuticals that resulted in the termination of licensing rights for BELBUCA. The company also achieved the highest net sales level for BELBUCA that led to the profitability of the commercial business unit.

Shares of BioDelivery Sciences International, Inc. (NASDAQ:BDSI) were up by 5.26% on the earnings report – ending Monday’s trading session at $2 a share.

During the quarter BioDelivery Sciences International, Inc. (NASDAQ:BDSI) also received the U.S. Food and Drug Administration’s (FDA) approval for a supplemental New Drug Application (NDA). The approval expanded the indication of BUNAVAIL to include treatment for opioid dependence.

Looking ahead the company is planning to execute two commercial transactions for BELBUCA in the U.S as it also eyes regulatory approval in Canada.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.