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Can BELBUCA repeat its record performance?

04 Mar Can BELBUCA repeat its record performance?

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical that seeks to address the unmet needs of patients suffering from Chronic and debilitating conditions. BELBUCA® (buprenorphine) is a buccal film that provides long-acting pain relief, by leveraging its BioErodible MucoAdhesive (BEMA®) technology, and is intended to be used in cases where around-the-clock, long-term treatment with an opioid or non-opioid treatment have proven to be ineffective or intolerable.

The Company’s BioErodible MucoAdhesive (BEMA®) technology improves the delivery of medication addressing the issue of poor oral absorption. It uses a small polymer film that is applied to the inner cheek, facilitating rapid absorption of the drug across the mucous membranes, especially optimizing time-sensitive treatments.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI)

Market Cap: $410.51M; Current Share Price: 4.06 USDChart
Data by YCharts

We take a look at 3 reasons why BioDelivery Services could be a good fit for your portfolio

Opioids – Growing Demand for Chronic Pain Relief Options
Chronic Pain is the leading cause for seeking medical aid in the U.S. A study undertaken by the Centres for disease control and prevention (CDC) in conjunction with NIH and other entities titled “Morbidity and Mortality Weekly Report (MMWR)” in the year 2016, estimates that 20.4% percent of the adults population in the U.S suffered from chronic pain, while 8 percent had high-impact chronic pain limiting at least one important activity in their daily life. Untreated or undertreated chronic pain contributes to $560 billion each year in direct medical costs, lost productivity, and disability programs in the U.S alone.

The global analgesic market is poised to amass $26.4 billion by 2022, growing at a CAGR of 7.1% during 2015 – 2022 , according to a report titled “Analgesics Market by Type (Non-opioids, Opioids) and Route of Administration (Oral, Intravenous, Rectal, Transdermal, Topical) – Global Opportunity Analysis and Industry Forecast, 2015 – 2022” published by Allied Market Research.

The Analgesic market is broadly divided into Opioid and Non-Opioid therapeutics. Opioid based medicine has given rise to an addiction endemic with prescription drug overdose becoming one of the leading causes of preventable deaths in the U.S in turn prompting the government to declare a public health emergency in 2017.

An increase in the geriatric population along with a rise in life-style related ailments and chronic diseases will drive the growth in the pain management therapeutic markets, along with a favourable government and regulatory environment, increased spending on research and development and fast track approvals for breakthroughs.

BELBUCA – Strong Performance and Continuing Growth
BELBUCA Film, a medicated Buprenorphine, has shown tremendous growth in prescriptions and market share. The drug is an opioid analgesic that is used to relieve chronic pain. The Company reacquired the worldwide rights to the drugs from Endo Pharmaceuticals, Inc. (NASDAQ: ENDP) in December 2016.

As per its Q3, 2020 financial results BELBUCA was the driving factor behind the Company’s 30 percent increase in net revenue which reached record levels of $39.4 Million compared to $30.3 million in the third quarter of 2019, with BELBUCA contributing $34.8 million of the net sales, a 31 percent increase compared to $26.5 million in the third quarter of 2019. In Q3,2020, the drug reached the highest prescription volume and market share with more than 114,500 BELBUCA prescriptions, denoting a volume growth of 25 percent.

Image Source: Company

Despite the Pandemic, the Company managed to achieve growth in the new-to-brand scripts in the third quarter with the help of its “First Start”, an innovative program that enables healthcare providers to prescribe the drug to eligible patients for the first time, without a financial outlay and through prior authorization approval, adding to patient convenience. This has helped boost NBRx scripts for BELBUCA.

BELBUCA also enjoys a strong commercial coverage with close to 94% of lives covered, with nearly 60% covered at a preferred level. The Company has entered into several agreements with Medicare insurers such as Cigna Corp (NYSE: CI), Medicare and EnvisionRx. The Company is upbeat about the prospects of BELBUCA and expects another record-breaking performance in Q4,2020.

SYMPROIC – A Synergistic Fit
In April 2019, the Company acquired the U.S commercial rights to Symproic® (naldemedine), an OIC medication that eases opioid constipation. The drug was acquired from Shionogi, Inc for an initial payment of $20 million and an additional $10 million in six months, along with tiered royalty payments based on Net Sales of Symproic.

Image Source: Company

Symproic registered an all-time high for TRx volume and market share, with Q3 prescriptions reaching a new high of over 18,100, a 12.1% increase year-over-year compared to Q3 2019 and a 3.1% increase over Q2 2020 as per the Company. Net sales for Symproic Q3 2020 was $3.5 million, which reflects 59% growth year-over-year and an increase of 1% compared to $3.4 million in Q2,2020.

The drug also had two significant market access wins with Prime Therapeutics and CVS in 2020. Prime Therapeutics moved the drug to a preferred exclusive position and CVS has accorded it a co-preferred position with Movantik.

Positive Estimates
According to analyst estimates, the Company is expected to post $38.75 million in sales for Q4,2020, with the highest sales estimate being $41.50 million, while the lowest being $36.60 million. Full-year sales are likely to be in the range of $150.90 million to $155.00 million.

Analysts expect that for the next financial year, the Company will post sales in the range of $177.70 million to $205.60 million.

Image Source: Company

Key Takeaways

  • The Company believes that the long-term net sales potential of its product portfolio to be in the range of $325 – $400 million. BDSI announced the discontinuation of marketing of BUNAVAIL in March 2020 as the drug was facing competition from generics such as Suboxone and operated in a highly competitive market with players like Pfizer’s Embeda battling for a share of the same pie.
  • To meet the challenges posed by the COVID-19 pandemic, the Company has launched a wide array of customer and patient support programs enabling the transition of customer engagement to virtual channels. A cross-functional Covid-19 committee has been constituted to prioritize investments and mount a prepared response.
  • BDSI intends to increase its digital presence to cater to both Health care professionals as well as patients, owing to the changing landscape. The Company has already built a virtual customer engagement platform, a dedicated email portal and has infrastructure in place to ship samples and resources directly to the physician’s office. This is to ensure that lower in person visits due to the pandemic restrictions do not have an impact on its prescriptions or new customer acquisition.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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    References

    https://www.belbuca.com/

    https://ir.bdsi.com/news-releases/news-release-details/biodelivery-sciences-reports-strong-q3-2020-results

    https://ir.bdsi.com/news-releases/news-release-details/biodelivery-sciences-reacquires-license-belbucatm-endo

    https://www.globenewswire.com/news-release/2019/04/10/1802297/0/en/BioDelivery-Sciences-Acquires-U-S-Commercial-Rights-to-Symproic.html

    https://www.nasdaq.com/articles/heres-why-you-should-add-biodelivery-stock-to-your-portfolio-2020-01-27

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