• UBI says sales orders in December will exceed $1m
  • Botanix submits NDA application for Sofdra to the FDA
  • Pacific Smiles rejects takeover bid


UBI says sales will exceed $1m in December

Universal Biosensors (ASX:UBI) says sales orders in December are forecast to exceed $1,000,000 (unaudited estimate).

This follows UBI’s largest order ever for Xprecia Prime devices from India. The order was for 520 devices, which are to be delivered in December.

Separately, UBI said it has submitted a full response to the FDA’s “Request for Additional Information” on 23 November.

Assuming there are no further queries, an FDA decision regarding the approval of Xprecia Prime for sale in the USA is expected during Q1 2024.

“December is forecast to be UBI’s biggest revenue month ever and is the first time we expect to record $1,000,000 from selling our products directly to customers, excluding Siemens,” said UBI CEO, John Sharman.

“Six of UBI’s new products have been in the market for approximately six months, and sales growth during H2 2023 has been strong compared with H1 2023.

“We now have 11 revenue generating products in market and we are starting to build sales momentum.”

The Xprecia Prime device is a second generation coagulation monitoring device that fits in the palm of your hand.

The device is designed for fast and reliable prothrombin time (PT) results displayed in seconds and International Normalised Ratio (INR). It is used to monitor the dosage of vitamin K antagonists in patients to ensure its safety and efficacy.


Botanix resubmits NDA application to FDA

Dermatology biotech, Botanix Pharma (ASX:BOT), has just completed resubmission of its New Drug Application (NDA) for Sofdra to the FDA.

The resubmission was originally planned for Q1 2024, but the Botanix team accelerated the process and filed earlier than expected.

The NDA resubmission follows successful completion of the human factors validation study, assessing revised Instructions for Use (IFU) for Sofdra.

The resubmission of the Sofdra NDA is in response to an FDA complete response letter announced on 26 September.

The only deficiency identified in the FDA Letter was focused on the IFU for Sofdra, which is the paper insert in the product carton that instructs the patient how to use the product safely and effectively.

No efficacy, safety, pharmacology, non-clinical or chemistry, or other manufacturing and controls (CMC) issues were identified.

Commercial preparations for the launch of Sofdra are now underway as the target for FDA approval has now been moved forward to late Q2 2024.

Sofdra, or Sofpironium Bromide gel, 15%, is Botanix’s lead product.

The drug treats primary axillary hyperhidrosis, where excessive sweating occurs beyond what is needed to maintain normal body temperature.


Pacific Smiles provides guidance, rejects takeover bid

Dental clinics network, Pacific Smiles Group (ASX:PSQ), provided an update on its trading performance as of the close of business on 20 December.

Patient fees came in $141.1m, a 10.5% increase YoY, and same centre patient fees also increased 9.7% YoY.

PSQ has also provided guidance for FY24.

Patient fees for the full year are expected to come in the range of $293m to $297m, and Underlying EBITDA in the range of $26m to $28m.

Additionally, PSQ said the board has assessed the $1.40 in cash per share takeover offer from Genesis Capital submitted earlier this week.

Despite acknowledging that the share price performance of Pacific Smiles has been disappointing, the board considers that the offer is “opportunistic and materially undervalues Pacific Smiles”, and has therefore rejected the proposal.


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