Pablo Legorreta, Royalty Pharma CEO (Paul Morris/Bloomberg via Getty Images)

BioCryst gets mas­sive cash in­fu­sion to the tune of $350M, thanks to old and new in­vestors

BioCryst is fill­ing its cof­fers again — this time in $350 mil­lion cash with the help of both old and new in­vestors.

The Durham, NC biotech re­port­ed this morn­ing that it inked yet an­oth­er deal along­side a fa­mil­iar name — Roy­al­ty Phar­ma for $200 mil­lion. Roy­al­ty was the same com­pa­ny that paid $125 mil­lion to BioCryst $BCRX last year in ex­change for prof­its from the then-re­cent­ly ap­proved oral HAE drug Or­ladeyo.

And Cana­di­an in­sti­tu­tion­al in­vestor OMERS — the one in charge of all lo­cal gov­ern­ment pen­sions in On­tario, CA — al­so signed up for $150 mil­lion up­front.

The cash flow will help ad­vance an­oth­er drug in BioCryst’s pipeline — oral Fac­tor D in­hibitor BCX9930 — to­ward fil­ing for reg­is­tra­tion and ex­pand de­vel­op­ment to mul­ti­ple undis­closed in­di­ca­tions.

And of course, it will help in­vest some more in­to Or­ladeyo’s glob­al launch af­ter it got ap­proved by the FDA last De­cem­ber.

Jon Stone­house

“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 BioCryst CEO Jon Stone­house in a pre­pared state­ment.

Here’s how the $350 mil­lion is bro­ken down:

Roy­al­ty Phar­ma signed up for $200 mil­lion — $150 mil­lion up­front as cash in ex­change for roy­al­ties on three of BioCryst’s drugs: BCX9930, an un­named, ear­li­er stage Fac­tor D in­hibitor and Or­ladeyo.

The roy­al­ties on the Fac­tor D in­hibitors are 3.0% on sales up to $1.5 bil­lion and 2.0% on sales be­tween $1.5 bil­lion and the cap of $3.0 bil­lion.

Roy­al­ty Phar­ma al­so now owns roy­al­ties of 0.75% on di­rect an­nu­al net sales of Or­ladeyo up to $350 mil­lion, and ex­pand­ed to 1.75% on sales be­tween $350 mil­lion and the max of $550 mil­lion. The deal al­so adds a tiered, de­clin­ing per­cent­age on Or­ladeyo sub­li­cense rev­enue in cer­tain ter­ri­to­ries.

These roy­al­ties are ad­di­tion­al to the roy­al­ties pur­chased by Roy­al­ty Phar­ma last De­cem­ber.

Roy­al­ty Phar­ma al­so ex­tend­ed the deal with BioCryst with a $50 mil­lion eq­ui­ty in­vest­ment at a price of $13.00 per share, the av­er­age price of BioCryst’s com­mon stock over the last 20 days.

“We are ex­cit­ed to ex­pand our part­ner­ship with BioCryst to con­tin­ue to sup­port their growth jour­ney,” said Roy­al­ty Phar­ma founder and CEO Pablo Legor­re­ta.

Now it’s OMERS’ turn. In ex­change for $150 mil­lion in cash, OMERS bought capped and tiered roy­al­ties for an­nu­al net sales of Or­ladeyo. BioCryst won’t owe OMERS any roy­al­ties for the first two years — leav­ing the first roy­al­ty pay­ment to OMERS for Q4 2023.

And since the roy­al­ties are capped, no more roy­al­ties will be paid out to OMERS once it gets its max­i­mum to­tal re­turn, ac­cord­ing to a BioCryst state­ment.

OMERS will re­ceive a roy­al­ty of at least 7.5% on an­nu­al net sales up to $350 mil­lion, and 6.0% on sales be­tween $350 mil­lion and the max of $550 mil­lion.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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