BioNTech’s ambitions for 2021 and beyond: ‘We will apply the capabilities we have developed with COVID-19 to rapidly advance other innovative medicines to the market’
The German biotech was founded in 2008 in Mainz by husband and wife team Dr. Ugur Sahin and Dr. Özlem Türeci, with the aim of developing pioneering therapeutics for cancer and beyond.
An early decision in January 2020 to tackle the SARS-CoV-2 virus 'head on’ pivoted the direction of the company: and the resulting COVID-19 vaccine BNT162b2 became the company's first commercial product to market.
But while the company is of course now well-known for this COVID-19 vaccine, its technology covers mRNA therapeutics, cell therapies, antibodies and small molecule immunomodulators.
And the company promises that 2021 will see innovation in these areas expand and accelerate, as well as continuing work on its COVID-19 vaccine for new variants and long-term protection.
The biggest highlight for 2020 was BioNTech’s first product launch – nothing less than the COVID-19 vaccine BNT162b2 – which is now authorized for use in more than 65 countries with more than 200 million doses delivered to date.
This has been accompanied by manufacturing and geographical expansion. BioNTech acquired its own commercial-scale production facility from Novartis last year to produce the vaccine (this facility is one of the largest in the world for mRNA vaccine production) which is now gearing up to supply its first doses next month. It also grew its global footprint to more than 1,900 employees: with around 600 of these in R&D positions.
It also expanded sites in Germany and established a US headquarters in Cambridge with the $67m acquisition of Neon Therapeutics (announced in January to create a US hub for research and clinical development, as well as focusing on expanding BioNTech's CAR-T and TCR therapy pipeline through addition of neoantigen specific cell therapies).
And while COVID-19 has been dominating the headlines, the company has also made progress in potential oncology treatments and champions their potential for the future.
“Despite COVID-19 being the spotlight last year, we made progress in advancing our oncology pipelines," highlighted CEO Dr. Ugur Sahin in this week's FY2020 earnings call. "We now have 13 oncology candidates in 14 ongoing trials across four different drug classes. Many of these products demonstrated promising activity in phase 1 clinical trials and we plan to initiate multiple phase 2 trials this year.”
Goals for 2021: 'We learned from COVID-19 that drug development can be faster'
There will be plenty going on with BNT162b2 to keep the company busy in 2021: with ongoing trials assessing booster shots for long-term protection; the vaccine in pregnant women, children and adolescents; its efficacy against virus variants, and more.
BioNTech and Pfizer have now upped their production expectations for 2021 to 2.5 billion doses, thanks to increased manufacturing capabilities boosted by the Marburg facility and optimized operational efficiencies.
And BioNTech says COVID-19 is likely to become endemic: with re-vaccination required or new vaccines required against new variants.
But beyond COVID-19, company is now pledging to accelerate and expand its wider innovation pipeline, launching multiple products over the next five years and learning lessons from COVID-19 vaccine development to propel this forward.
Having established mRNA vaccines as a new drug class in 2020, it now wants to use that technology to displace traditional modalities across other infectious disease vaccines; as well as exploring mRNA cancer vaccines, a CAR-T cell amplifying mRNA vaccine, and systemic mRNA encoded immunotherapies.
And beyond that, it sees the potential of mRNA to open up new opportunities: in autoimmune diseases, allergies, inflammation, regenerative medicines and other therapeutic areas.
“We learned from our COVID-19 experience that product development can be faster," noted Sahin. "While COVID-19 was an extraordinary case, we intend to apply the capabilities we have developed during ‘Project Lightspeed’ to rapidly advance other innovative medicines to the market.
“The success of ‘first-generation’ mRNA vaccines against COVID-19 highlights their future promise – we expect rapid iterations to further improve this new class of productions. We have established a broad toolbox of mRNA technologies that underpin a diverse range of mRNA platforms.
“BioNTech is well-placed to lead at the intersection of mRNA and immunology: we own a vast IP portfolio and have more than a decade of accumulated know-how in the field. We plan to increase investment in our technology platforms to accelerate our platform and pipeline and stay at the forefront of the field.”
Expected pipeline milestones for 2021
- Multiple BNT162b2 COVID-19 vaccine updates (such as trials on a third booster shot, the vaccine in pregnant women and children, etc).
- BNT311: Bi-specific CPI: PD-L1 x 4-1bb in solid tumors
- BNT312: Bi-specific checkpoint Immunomodulator CD40 x 4-1bb in solid tumors
- BNT211: CLDN-6 CAR-T + CARVac in solid tumors
- BNT411: TLR-7 Agonist +/- CPI in solid tumors
Randomized Phase 2 trial starts:
- BNT111: FixVac melanoma +CPI in refractory melanoma
- BNT133: FixVac HPV16+ + CPI in 1L HNSCC and cervical cancers
- BNT122: iNeST (autogene cevumeran) + CPI in adjuvant mCRC
Entering clinical trials:
- BNT211: CLDN-6 CAR-T + CARVac in solid tumors
- BNT151: Ribocytokine (modified IL-2)
- BNT152+153: RiboCytokine IL-2 / IL-7 combo in solid tumors
- BNT141: RiboMab (undisclosed)
- BNT142: RiboMab bi-specific CPI in solid tumors (CD3xCLDN6)
- BNT221: NEOSTIM individualized neoantigen-T cell therapy in melanoma
BioNTech’s COVID-19 vaccine revenues expected to reach $11.51bn
BioNTech has swung from a net loss of €179.2m ($210m) net loss in 2019 to a net profit of €15.2m ($17.8m) in 2020.
Unsurprisingly, it was COVID-19 vaccine deliveries that drove revenue growth (total COVID-19 vaccine revenues reached €270.5m / $317m for FY2020). Total revenues for 2020 quadrupled from €109m ($127m) in 2019 to €482m ($565m) in 2020.
But the headline figure is that BioNTech has now put an estimate on its COVID-19 vaccine revenues for 2021: indicating this will come in at €9.8bn ($11.51bn) on the basis of existing signed supply contracts for 1.4 billion doses (in reality, this is expected to rise as more deals are signed).
Announced in March 2020, the Pfizer & BioNTech partnership was formed to accelerate development of BioNTech’s mRNA COVID-19 vaccine program: with Pfizer paying BioNTech $185m upfront (across a cash payment and equity investment) with BioNTech eligible to receive milestone payments of up to $563m. The two companies have been working jointly to develop and commercialize the vaccine worldwide (excluding China, which is covered by BioNTech’s collaboration with Fosun Pharma).
This estimate is based on expected revenues from direct COVID-19 vaccine sales to customers in its territories; expected revenues from sales to collaboration partners; sales milestone payments from collaboration partners; and revenues related to its share of gross profit from vaccine sales in Pfizer’s territory.
In February, Pfizer was forecasting $15bn in sales from the vaccine in 2021 on the basis of existing contracts signed at that time (it did not specify how many doses this covered).
Ramping up R&D
BioNTech's R&D expenses increased from €226.5m in 2019 to €645m in 2020, mainly due to the BNT162 COVID-19 vaccine program. Development costs for the vaccine are split equally between BioNTech and Pfizer.
“The increase [in R&D expenses] was further driven by an increase in expenses for purchased laboratory supplies as well as an increase in headcount leading to higher wages, benefits and social security expenses,” notes BioNTech. “In addition, from May 6, 2020, the date of acquisition of our new US-based subsidiary, BioNTech US Inc., contributed to our research and development expenses. “
In 2021, the company plans to continue ramping up R&D with expenses set to rise from 2020's €645m to up to €850m: with the company putting its money where its mouth is when it comes to big plans for its broader pipeline.