Company: SMNR
Filing Date: 2025-08-08
Form Type: S-4/A
Source: 0001193125-25-177097
Chunk: 358

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-08
Form: S-4/A
Chunk 358
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 internal market assessment (including physician input and current physician practices) of off-label use of epidural injections, Semnur management believes that physicians will use SP-102 “off-label” — without FDA approval — for the following Non-LR indications: cervical radiculopathy, knee arthritis, hip and knee replacements, complex regional pain syndromes, lumbar spinal stenosis, acute spinal injury, discogenic pain, and injections for knee, shoulders, wrists, ankles and joints. Semnur estimates that Non-LR gross sales will account for approximately 55% of estimated gross sales for each period on an aggregate basis, but has not otherwise estimated sales on a per Non-LR indication basis. Semnur is not currently targeting or otherwise seeking FDA approval for the use of SP-102 for any Non-LR indications. |

| (b) | In addition to Semnur management’s internal analysis of the results of the Research Report, Semnur’s management also considered primary market research with healthcare professional specialists as well as Semnur’s assessment of the competitive landscape and that there are currently no FDA-approved epidural steroid injection therapies for sciatica (which, if approved, would make SP-102 the first such product to be approved), and as a result Semnur’s management is conservatively projecting market share of 0.5% during the first year of launch with peak market share of 35.8% in the seventh year post launch, decreasing to 27.3% after the expiration of the SP-102 patent in 2036 and gradually declining each year thereafter to 11.6% in 2043. |

| (c) | Semnur’s management estimates that the price per injection will be $500 the first year after the commercial launch, with an inflation adjustment of 3% per year thereafter. Based on the above projected price per unit, market share and market growth rate information, Semnur projected annual sales of approximately $66.9 million in the first year after the commercial launch of SP-102, and annual sales of approximately $5.9 billion in the fifth year after the commercial launch, which will grow to the peak of approximately $7.1 billion in 2036 and will begin to decline gradually after the expiration of the SP-102 patent. Semnur’s management anticipates revenues will drop to approximately $5.6 billion during the first year after the expiration of the SP-102 patent and continue to decline to approximately $2.6 billion