Among the regulatory decisions expected in 2023 are those for its RSV vaccine candidate – for which there is no currently authorized vaccine – as well as its Prevnar 20 pediatric vaccine.
Reporting its FY2022 results on Tuesday, Pfizer noted revenues of $100.3bn – an all time high for the company. But these revenues are set to plummet to the region of $67bn - $71bn as the COVID-19 products market hits a 'low point' in 2023.
Against this backdrop, the company highlights the variety of programs and anticipated launches for 2023 outside of its COVID-19 portfolio of Comirnaty and Paxlovid.
And fueling this innovation is a boost in R&D spending, increasing 'at least' 8.7% in 2023 to $12.4 - $13.4bn.
A changing market for COVID-19 products
If the COVID-19 products market is removed from calculations, Pfizer expects to see 7% to 9% operational revenue growth in 2023 across its portfolio.
"We expect our potential new launches, newly acquired products and in-line products will all contribute to this growth," said Pfizer CEO Albert Bourla. "These projections include our forecast for several important potential product launches, including our RSV vaccine for older adults, potential Prevnar 20 pediatric indication, and products and candidates that came to us through recent business development activities: including etrasimod for ulcerative colitis, Nurtec and zavegepant for migraine and Oxbryta for sickle cell disease.
"We are in the midst of an 18-month period during which we expect to have up to an unprecedented 19 new products or indications in the market. 15 of these 19 are from our internal pipeline, with the remaining four coming to Pfizer via these recent business development deals."
The company also has many more launches expected past 2024, providing they prove successful in clinical trials and are approved by regulators. That includes an oral GLP-1 candidate for diabetes and obesity; combo vaccines for flu, COVID-19 and RSV; the company's vaccines for Lyme disease and shingles; multiple new oncology product candidates (including ARV-471 and our CDK4 inhibitor for endocrine receptor-positive breast cancer); gene therapy candidates for hemophilia A, hemophilia B and Duchenne muscular dystrophy; a pan-hemophilia A&B antibody treatment; and more.
Programs to watch
Pfizer currently has 16 programs in the registration phase and 23 in Phase 3. Adding in its wider pipeline (37 in Phase 2 and 34 in Phase 1), it has a total of 72 new molecular entities and 38 additional indications.
- Of note in 2023 is its race against GSK to bring the first RSV vaccine to market: with a decision for both candidates for ages 60+ expected from the FDA in May. Following this, Pfizer hopes to hear a decision on its maternal RSV vaccine in the second half of the year.
- Last month, the FDA accepted for review a supplemental Biologics License Application (sBLA) for Pfizer’s 20-valent pneumococcal conjugate vaccine candidate Prevnar 20 in infants and children 6 weeks through 17 years of age: with a decision anticipated in April 2023.
The flip side: discontinued programs
Pfizer has discontinued eight programs recently. These include additional indications for Paxlovid; PF-07284890, a BRAF BP kinase inhibitor for melanoma; and PF-06873600, a CDK 2,4,6 inhibitor for metastatic breast cancer.
- The FDA has also accepted a BLA for Pfizer’s investigational pentavalent meningococcal vaccine candidate, MenABCWY, in individuals 10 through 25 years of age. If approved and recommended, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine, according to the company. The PDUFA goal date for a decision by the FDA is in October.
- And although the review period for Paxlovid’s NDA has been extended so the FDA can consider additional data, the PDUFA goal date is still fast approaching in June (back from May).
- The FDA is also assessing a NDA for etrasimod (a selective S1P receptor modulator that Pfizer gained via its acquisition of Arena Pharmaceuticals in 2021) for individuals living with moderately-to-severely active ulcerative colitis (UC), with a decision expected in the second half of this year (In the EU, a decision is expected to follow in the first half of 2024).
- With FDA breakthrough therapy designation granted last year, elranatamab - a drug with 'blockbuster potential' - could potentially be approved this year, notes Pfizer (the company recently presented updated phase 2 data on the investigational B-cell maturation antigen, or BCMA, CD3-targeted bispecific antibody, for relapsed or refractory multiple myeloma in heavily pre-treated patients who had received at least three classes of prior therapies).
- At the end of December, Pfizer announced positive top line results for the Phase 3 study of hemophilia B gene therapy Fidanacogene elaparvovec: with the company pledging at the time to discuss these data with regulatory authorities in the early part of this year.
- A Phase 3 read-out for Marstacimab for patients with hemophilia a and b is expected in Q2, 2023; with a potential launch coming in or after 2024.
- Pfizer's mRNA flu vaccine, currently in Phase 3 trials, is also looking towards a potential launch as early as 2024.
- DMD GTx, a Duchenne Muscular Dystrophy gene therapy, could also see a launch from 2024.
- Meanwhile, Pfizer’s Lyme Disease vaccine candidate – developed with Valneva and the only one against the disease in clinical development – started a Phase 3 trial last year, with the hope of filing a BLA to the FDA and EMA in 2025.
“2022 was a record-breaking year for Pfizer, not only in terms of revenue and earnings per share, which were the highest in our long history,” said Dr. Albert Bourla, Chairman and CEO.
“As we turn to 2023, we expect to once again set records, with potentially the largest number of new product and indication launches that we’ve ever had in such a short period of time. We believe that the combination of these expected near-term launches, additional pipeline products that could potentially come to market in the medium-term, and anticipated contributions from business development, has the potential to set the company up for continued robust growth through the rest of this decade and beyond.”