NEW YORK, RESEARCH TRIANGLE PARK, N.C. and TORONTO, Nov. 22, 2021 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX), Royalty Pharma plc (Nasdaq: RPRX) and OMERS Capital Markets (OMERS), today announced transactions totaling $350 million in new funding for BioCryst, with all funds immediately available at closing.
The funds from these transactions will enable further advancement of BCX9930, BioCryst’s oral Factor D inhibitor, toward filing for registration, expand the development of BCX9930 across multiple indications and support additional investment in the global launch of ORLADEYO® (berotralstat), which is on a trajectory to become the market-leading prophylactic hereditary angioedema (HAE) therapy.
For a $150 million upfront cash payment, Royalty Pharma, the largest buyer of pharmaceutical royalties globally, has purchased royalties on combined annual net sales of BCX9930 and another earlier stage Factor D inhibitor of 3.0% on sales up to $1.5 billion, 2.0% on sales between $1.5 billion and $3.0 billion, and no royalty on sales over $3.0 billion. Royalty Pharma also purchased royalties of 0.75% on direct annual net sales of ORLADEYO up to $350 million, 1.75% on sales between $350 million and $550 million, no royalty on sales over $550 million, and a tiered, declining percentage on ORLADEYO sublicense revenue in certain territories. These royalties are additional to the royalties purchased by Royalty Pharma in December 2020.
For a $150 million upfront cash payment, OMERS, one of Canada’s largest defined benefit pension plans, has purchased a capped, tiered, declining royalty on direct annual net sales of ORLADEYO. Under the agreement, BioCryst does not owe any royalties for the first two years. The first royalty payment from BioCryst to OMERS will occur based on royalties from direct annual net sales of ORLADEYO in the fourth quarter of 2023. Once OMERS has achieved its maximum allowed total return under the agreement, no further royalty payments will be owed. OMERS will receive a royalty of at least 7.5% on annual net sales up to $350 million, 6.0% on sales between $350 million and $550 million and no royalty on sales over $550 million. The maximum total return OMERS may earn under the agreement is capped at 1.425x or 1.550x, based on the level of 2023 global net sales of ORLADEYO relative to a prespecified sales threshold.
Royalty Pharma also has extended its relationship with BioCryst through a $50 million equity investment at a price of $13.00 per share, the volume-weighted average price of BioCryst common stock over the past 20 days.
“We are excited to expand our partnership with BioCryst to continue to support their growth journey,” said Pablo Legorreta, founder and chief executive officer of Royalty Pharma.
“Following our initial investment nearly one year ago, ORLADEYO has proven to be a transformative therapy for HAE patients. We are also thrilled to make an additional investment in BCX9930 following strong proof of concept data, which will support and expand the rapid development of BCX9930 in paroxysmal nocturnal hemoglobinuria (PNH) and multiple other complement-mediated diseases. Our equity investment underpins our conviction in the BioCryst team and the substantial patient need for innovative oral therapies in rare disease,” Legorreta added.
“Almost a year into its launch, BioCryst has established ORLADEYO as a leading HAE prophylactic therapy. This investment provides direct exposure to a high-quality pharmaceutical asset and aligns well with our mandate to deliver steady long-term returns to our 525,000 members,” said Rob Missere, managing director and head of life sciences, OMERS Capital Markets.
“The focused execution of our plan this year, with the successful launch of ORLADEYO and the rapid advancement of BCX9930, has led to further investment from exceptional and committed partners like Royalty Pharma and Athyrium, and new investment from OMERS. The infusion of $350 million on top of our growing revenue base from ORLADEYO, and our existing cash, enables us to invest now to maximize the value of our oral Factor D program and ORLADEYO. We appreciate the confidence our partners are demonstrating in BioCryst with this financing as we continue to bring oral medicines to patients with rare diseases,” said Jon Stonehouse, chief executive officer of BioCryst.
BioCryst also is pleased to continue its strong partnership with Athyrium Capital Management. Having now achieved the defined ORLADEYO revenue milestones in its prior agreement with Athyrium, BioCryst has committed to access the additional $75 million available under the agreement and will draw this $75 million in mid-2022.
The new financing enables BioCryst to further advance and expand its Factor D program over the next two years by achieving the following:
- Complete and report data from the ongoing REDEEM-1 and REDEEM-2 pivotal trials in PNH
- Complete the renal proof-of-concept (PoC) basket trial in three nephritis indications and advance to pivotal trials in each
- Commence PoC trials in other complement-mediated diseases
- Prepare to submit regulatory approval filings in PNH
Cowen acted as financial advisor to BioCryst on the transaction. Gibson Dunn acted as legal advisor to BioCryst. Goodwin Procter, Wolf Greenfield and Maiwald acted as legal advisors to Royalty Pharma. Sidley Austin LLP acted as legal advisor to OMERS.
About ORLADEYO® (berotralstat)
ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
U.S. Indication and Important Safety Information
INDICATION
ORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
IMPORTANT SAFETY INFORMATION
An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.
The most common adverse reactions (≥10 percent and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.
A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).
Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.
ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.
The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.
There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO® (berotralstat) is approved in the United States, the European Union, Japan, the United Arab Emirates and the United Kingdom. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection) has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com.
About OMERS
Founded in 1962, OMERS is a jointly sponsored, defined benefit pension plan, with 1,000 participating employers ranging from large cities to local agencies, and over half a million active, deferred and retired members. Our members include union and non-union employees of municipalities, school boards, local boards, transit systems, electrical utilities, emergency services and children’s aid societies across Ontario. OMERS teams work in Toronto, London, New York, Amsterdam, Luxembourg, Singapore, Sydney and other major cities across North America and Europe – serving members and employers and originating and managing a diversified portfolio of high-quality investments in public markets, private equity, infrastructure and real estate. OMERS had net assets of $114 billion as at June 30, 2021.
About Royalty Pharma
Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and not-for-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on around 40 commercial products, including AbbVie and Johnson & Johnson’s Imbruvica, Astellas’ and Pfizer’s Xtandi, Biogen’s Tysabri, Johnson & Johnson’s Tremfya, Gilead’s Trodelvy, Merck’s Januvia, Novartis’ Promacta, Vertex’s Kalydeco, Orkambi, Symdeko and Trikafta, and nine development-stage product candidates.
