TexasMarvL
5 days ago
10-Q said Q2 revenue fell off a cliff.
How long has it been since Verséa Ophthalmics LinkedIn page shared a post about a new #TPOCTITAN customer?
These results are a total disaster.
Only 1000 tests were sold in Q2.
On Page 28 of Q2 10-Q go to the bottom and read the last paragraph.
Cut/paste:
NOTE 13: COMMITMENT AND CONTINGENCIES (CONTINUED)
On September 15, 2022, the company entered into a license and distribution agreement for its Lactoferrin dry eye test, Ige allergy test for allergic conjunctivitis and quantitative MMp-9 test to identify ocular surface inflammation. The licensee is Versea Ophthalmics, LLC, A Delaware Limited Liability Company.
The agreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. The three AXIM’s key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 0.5 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.
Verséa plans to launch IgE and Lactoferrin tests at the upcoming 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in the next 18-24 months.
In recent months, AXIM has been preparing for the scaling of production of its tests in anticipation of an agreement such as the one reached with Verséa and is now prepared to support new orders associated with the agreement and subsequent launch.
In order to accommodate Versea we have arranged to have IUL a supplier of test readers to supply readers directly to Versea. Axim has no control over readers and receives no income as a result. This is reflected on a net basis on the financials with no profit or loss effect.
Due to the Agreement, the positions of: (i) National Sales Director; and (ii) Chief Medical Officer held by Jeff Busby and Dr. Joseph Tauber, respectively, were no longer necessary for Company operations and, therefore, eliminated.
The Company received an initial license fee of $150,000 and has the right to cancel the agreement if minimum sales targets are not reached. This amount was recorded as deferred revenue and amortized over 5 years beginning September 15, 2022. During the three and six months ended June 30, 2024 and 2023, the Company amortized $7,479, $14,958 and $7,397, $14,876 The carrying balance as of June 30, 2024 and December 31, 2023 was $96,189 and $111,209, respectively.
The Company also received $192,000 towards sale of its IgE and Lactoferrin tests. The tests were not shipped as of December 31, 2023 so the amount was disclosed as deferred revenue as of December 31, 2023. The initial agreement was made between the parties was $12 per test, but subsequently verbally it was agreed for $10 per test by both the parties.
During the quarter ending March 31, 2024 4,550 in tests were shipped at $10 per test resulting in revenue recognition of $45,500 and during the quarter ended June 30, 2024 1,000 tests were shipped resulting in 10,000 revenue recognition; leaving a carrying value of $136,500. There was a verbal agreement to reduce the selling price of the tests from $12- to $10-
mc73
2 weeks ago
I'm in the same position on a pharma company, new cancer treatment. Science works but they can't seem to get approval for human clinical trials.
The FDA is, in my opinion, an inept agency full of corruption, so their CEO may just not have the weight of a Pfizer for approval. Could also be that it is our CEO who just can't get the job done. Either way, I could be holding a big bag here soon if I don't monitor constantly.
Good luck to us all
TexasMarvL
1 month ago
K934473 - May 1st 2024. Title updated to "Evaluation of Dry Eyes"
https://www.myhealthtoolkit.com/web/public/brands/medicalpolicy/external-policies/evaluation-of-dry-eyes/
History From 2016 Forward
05/01/2024 Annual review, no change to policy intent. Updating rationale and references. Title updated to Evaluation of Dry Eyes.
01/09/2024 Updating review to April. No other changes.
10/31/2023 Moving Review to January. No other changes made.
04/10/2023 Corrected review date from 04/01/2023 to 12/01/2023 to coincide with Avalon review.
04/07/2022
Annual review, no change to policy intent. Updating rationale and references and adding table of terminology.
04/05/2021
Annual review, no change to policy intent. Updating rationale and references.
10/01/2020
Interim review, updating policy with medical necessity criteria: Testing of tear osmolarity in patients suspected of having dry eye IS MEDICALLY NECESSARY to aid in determining the severity of dry eye disease as well as to monitor effectiveness of therapy. Also updating description, rationale and references.
04/14/2020
Annual review, no change to policy intent.
04/03/2019
Annual review, no change to policy intent, but, expanding specificity of tests that are not medically necessary. Also updating coding.
04/17/2017
Interim review, month of review changed, no other changes.
12/04/2017
Interim Review. Updated policy section. No other changes made.
10/19/2017
Annual review, no change to policy.
04/26/2017
Updated category to Laboratory. No other changes.
12/05/2016
New Policy