Market Dynamics and Financial Trajectory for the Biologic Drug: Andexxa
Introduction
Andexxa, developed by Portola Pharmaceuticals, is a groundbreaking biologic drug designed to reverse the anticoagulant effects of factor Xa inhibitors, such as rivaroxaban and apixaban. This article delves into the market dynamics and financial trajectory of Andexxa, highlighting its impact, growth drivers, and financial performance.
Approval and Regulatory Milestones
Andexxa was approved by the U.S. FDA in May 2018, marking a significant milestone in the treatment of bleeding caused by factor Xa inhibitors. This approval was followed by a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, leading to the European Commission's approval of Ondexxya (the European brand name for Andexxa) in early 2019[5].
Market Growth Drivers
Several factors are driving the growth of the Andexxa market:
Increasing Hospital Admissions
The number of hospital admissions due to bleeding caused by factor Xa inhibitors has been increasing significantly. Between 2014 and 2015, over 50,000 patients treated with Xarelto and Eliquis were admitted to hospitals for excessive bleeding in the U.S. alone. This high demand for an antidote is a key driver for Andexxa's market growth[1][4].
High Target Population
The annual rate of bleeding due to factor Xa inhibitors ranges between 1% and 4% in the U.S., indicating a substantial target population for Andexxa. This high incidence of bleeding events necessitates the use of reversal agents, making Andexxa a highly sought-after treatment[1][4].
Strong Sales Performance
Andexxa has shown strong sales performance, particularly in the U.S. market. In the fourth quarter of 2019, Andexxa's global net revenues were approximately $28 million, with $24 million of that coming from the U.S. market. This represents a significant increase from the $14 million in net revenues in the same period a year ago[2].
Expansion into New Markets
The anticipated approval and ongoing clinical trials in Europe and Japan are expected to further drive the growth of Andexxa. The drug's approval in Europe in mid-2019 and its ongoing trials in Japan are crucial for expanding its global reach[1][4].
Distribution Channels
Hospital Pharmacies
The hospital pharmacies segment has dominated the distribution of anticoagulant reversal drugs, including Andexxa. This is due to the increased focus of manufacturing companies on supplying these drugs directly to hospital pharmacies, ensuring timely and efficient access to patients in need[1][4].
Financial Performance
Revenue Growth
Andexxa has demonstrated robust revenue growth since its approval. For the full year 2019, Andexxa's global net revenues were approximately $111 million, a significant increase from the $40.1 million in total revenues for the full year 2018[2][5].
Quarterly Performance
In the fourth quarter of 2019, Andexxa's global net revenues were approximately $28 million, with a notable contribution from the U.S. market. This quarter also saw $4 million in sales from Ondexxya in Europe, indicating a strong start in the European market[2].
Cash Position and Investments
Portola Pharmaceuticals has maintained a strong cash position, which is crucial for continuing to invest in the launch and marketing of Andexxa. As of December 31, 2019, the company’s cash position totaled $464 million, up from $317 million at the end of 2018[2].
Market Size and Projections
The global anticoagulant reversal drugs market, driven significantly by Andexxa, was valued at US$ 607.3 million in 2017 and is projected to expand at a high CAGR during the forecast period. The market is expected to be fueled by the increasing need for antidotes for factor Xa inhibitors, with over 500,000 hospital admissions globally requiring such treatments by 2020[4].
Regional Dominance
North America
North America, particularly the U.S., has been the dominant region for Andexxa's sales. The approval of Andexxa in May 2018 and the high target population for the drug have contributed to the market's growth in this region. The U.S. market is expected to expand at a high CAGR during the forecast period[1][4].
Impact of COVID-19
While the COVID-19 pandemic has had various impacts on pharmaceutical markets, the demand for anticoagulant reversal drugs like Andexxa has remained robust. The pandemic has not significantly altered the growth trajectory of Andexxa, as the need for effective reversal agents continues to rise[1][4].
Key Takeaways
- Approval and Expansion: Andexxa's approval in the U.S. and Europe, along with ongoing trials in Japan, has set the stage for its global expansion.
- Strong Sales Performance: Andexxa has shown significant revenue growth, particularly in the U.S. market.
- High Demand: The increasing number of hospital admissions due to bleeding caused by factor Xa inhibitors drives the demand for Andexxa.
- Dominant Distribution Channel: Hospital pharmacies remain the primary distribution channel for Andexxa.
- Financial Strength: Portola Pharmaceuticals' strong cash position supports continued investment in Andexxa's launch and marketing.
FAQs
What is Andexxa used for?
Andexxa is used to reverse the anticoagulant effects of factor Xa inhibitors, such as rivaroxaban and apixaban, in patients experiencing life-threatening or uncontrolled bleeding.
When was Andexxa approved by the FDA?
Andexxa was approved by the U.S. FDA in May 2018.
What is the global market size for anticoagulant reversal drugs?
The global anticoagulant reversal drugs market was valued at US$ 607.3 million in 2017 and is projected to expand at a high CAGR during the forecast period.
Which region dominates the sales of Andexxa?
North America, particularly the U.S., dominates the sales of Andexxa due to its high target population and strong sales performance.
How has the COVID-19 pandemic affected the market for Andexxa?
The COVID-19 pandemic has not significantly altered the growth trajectory of Andexxa, as the demand for effective reversal agents continues to rise.
Sources
- Biospace: Anticoagulant Reversal Drugs Market is predicted to Accelerate the Growth by 2018-2026
- Biospace: Portola Announces Preliminary Full Year 2019 Andexxa Global Net Revenues of Approximately $111 Million
- AstraZeneca: Full year and Q4 2022 results
- Biospace: Anticoagulant Reversal Drugs Market: AndeXXa to be Highly Lucrative Segment
- GlobeNewswire: Portola Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
