Maintaining Our FVE For BioNTech After Q3 Results

Following no-moat BioNTech’s BNTX third-quarter results, we are maintaining our fair value estimate of $65 per share, which already factors in our 90% probability of approval for its COVID-19 vaccine, BNT162b2, partnered with Pfizer (ex-China) and Fosun Pharma (China). Details around its vaccine program were the highlight of the quarter, but other drugs in the pipeline also demonstrated decent progress.

As we discussed in our note from Nov. 9, the vaccine’s efficacy in the first interim analysis from its phase 3 COVID study was over 90%, which evaluated 94 disease cases (44,000 patients enrolled) based on a 2-dose schedule. We expect its final analysis at 164 confirmed cases by the end of this month, and we strongly believe that regulatory agencies are likely to authorize the vaccine for emergency use in late 2020. In preparation for its commercial launch with its partners, the company acquired a manufacturing facility in Germany to boost its production capacity, and Pfizer and BioNTech have a goal of producing 1.3 billion doses in 2021. Pfizer and BioNTech continue to add supply agreements with governments and have already secured contracts for 570 million doses in 2021, with options for 600 million more.

In oncology, the pandemic continued to adversely affect enrollment of studies and clinical site initiations overall. Trial plans for both BNT111 for advanced melanoma and BNT113 for HPV16+ head and neck cancer are currently under review by the U.S. Food and Drug Administration, and both phase 2 trials have been pushed back to start in the first half of 2021. In addition, the company provided positive early phase 1 data for BNT311, its next generation immunotherapy for solid tumors, partnered with Genmab. Recently published data showed that BNT311 was generally well tolerated, with no patients showing great transaminase elevations, and achieved disease control in about 66% of these heavily pretreated patients with solid tumors.

Morningstar Premium Members gain exclusive access to our full analyst reports, including fair value estimates, bull and bear breakdowns, and risk analyses. Not a Premium Member? Get this and other reports immediately when you try Morningstar Premium free for 14 days.