As “promised”. Basically all figures are Q2 vs Q1 and in kUSD, unless noted differently. (Price for "120 casules" is in $)
Revenue: 97,554 “120 capsules” were delivered to wholesalers and the net price (after allowance, discount, etc.) was $129.22 (lower than in Q1). – Method: (Revenue + allowance, discount, etc from 10-Q) / $195.04 (wholesale price)
COGS: was $51.51 per “120 capsules” (lower than in Q1).
Gross Profit: 60,14% vs 61,28% as a result of higher allowance, discount, etc. 51% vs 39% based on Gross Revenue (GR: $19,027 vs. $15,266).
Research and development:
R-IT: Contract research organization cost was $7,8M vs. $5,1M and the clinical trial material was $1,4M vs $2,4M. (Note costs for CTM expensed upon receipt.). “We currently estimate that costs incurred for this study in 2014 will continue at approximately the same levels as we have incurred in 2013 but may vary from quarter to quarter.” (2013: Q3 – $9,126, Q4 – $15,896)
Internal staffing, overhead and other: decreased by 44% ($1,474 vs $2,614).
Selling General and Administrative: little bit higher due to KOWA co-promotion fee for 1,5 months. Additional increase expected in the second half due to “full” KOWA involvement and higher gross margin (as a base of KOWA’s fee)
Other income: Includes $3,0M settlement from BASF and from “one of our encapsulators that provided for the reimbursement of certain amounts previously paid by us.”
Cash-Flow: better by $13,486 ( -13,750 vs. -27,236) mainly as a result of:
- Other income: $4,209 (from BASF and Patheon)
- Accounts payable and other current liabilities: $8,989 (5,884 vs -3,105)
Additional info:
BioPharma: “The payment of $1.3 million for the second quarter of 2014 is due in August 2014.”
Purchase obligations (API): same as at the end of Q1, (no purchase in Q2).
If ANCHOR approved: stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $8.5 million at June 30, 2014) milestone payment to Laxdale.
class action lawsuits: „We believe that we have valid defenses and we will vigorously defend against this class action suit, but cannot predict the outcome. We are unable to reasonably estimate the loss exposure, if any, associated with the claims. We have insurance coverage that is anticipated to cover any significant loss exposure that may arise from this action after payment by us of the associated deducible obligation under such insurance coverage”
“We currently rely on Patheon (formerly Banner Pharmacaps) for the encapsulation of Vascepa. We have encapsulation agreements with two other commercial API encapsulators. These companies are working to qualify their processes and to prove that the Vascepa capsules they produce meet the same quality standards as the capsules produced by Patheon. There can be no guarantee that additional other suppliers with which we have contracted to encapsulate API will be qualified to manufacture the product to our specifications…”
