Original Source: FD (FAIR DISCLOSURE) WIRE
. Erika Luib, Ligand Pharmaceuticals Incorporated, IR . John Higgins, Ligand Pharmaceuticals Incorporated, President . John Sharp, Ligand Pharmaceuticals Incorporated, CFO . Martin Meglasson, Ligand Pharmaceuticals Incorporated, Head of Discovery Research . Derek Jellinek, Roth Capital Partners, Analyst
LGND reported 2Q08 revenue from continuing operations of $4.8m, total net loss of $6.4m or $0.07 per share.
A. Key Data From Call 1. 2Q08 revenue from continuing operations = $4.8m. 2. 2Q08 total net loss = $6.4m. 3. 2Q08 loss per share = $0.07. 4. 2Q08 total OpEx = $10.9m. 5. Cash, cash equivalents, short-term investments and restricted investments at 2Q08-end= $86.4m.
S1. 2Q08 Business Review (J.H.) 1. Highlights: 1. LGND has had a number of recent positive developments with partnered programs.
1. Is making real progress with Co.'s three main internal programs.
2. Is running the business efficiently from an operational and
cost perspective. 2. Partnered Programs: 1. Has valuable license agreements with GSK, Wyeth and Pfizer for drugs that Co. collaborated on for drug discovery. 1. All three companies have drug applications that are pending to FDA action. 2. Co. is awaiting the FDA outcomes. 2. GSK: 1. LGND has a license agreement with GlaxoSmithKline for PROMACTA. 2. Believes given the potential size of TPO market, the status of drugs in development and competitive positioning of the various players, that the opportunities for LGND and GSK are
promising for this program. 3. FDA extended priority review of the NDA for PROMACTA for the short-term treatment of ITP, PDUFA action date is now scheduled for 09/19/08. 4. GSK mentioned in its recent quarterly conference call that they should expect to see positive agency action before the PDUFA date in Sept. 5. In May, FDA's ODAC panel unanimously voted 16 to zero that PROMACTA demonstrated a favorable risk benefit profile for the short-term treatment, patients with chronic ITP. 6. GSK filed the first NDA for this drug for the short-term treatment of ITP at the end of last year. 7. GSK expects to make MAA for Europe and NDA submissions for the long-term treatment of ITP later on this year. 8. In addition to ITP, GSK also has several other important clinical trials underway with PROMACTA, including: 1. Two Phase III studies for hepatitis C. 2. Multiple Phase II trials for CIT. 3. Phase I trial in sarcoma.
3. Wyeth: 1. Received a third approvable letter for VIVIANT
(bazedoxifene). 2. States that they are on track to file a complete response with the FDA by year-end and expects that following the FDA's review of the response, VIVIANT, will move forward to an FDA advisory committee meeting. 3. For APRELA, which is bazedoxifene in combination with PREMARIN for the treatment of vasomotor symptoms and prevention of osteoporosis, Wyeth has completed the bio-equivalent studies. 1. Co. anticipates they will submit an NDA for that drug in 2H09. 4. Pfizer: 1. In Jan. 2008, Pfizer submitted an application in the EU for osteoporosis treatment for FABLYN, which was formerly branded Oporia. 2. NDA for …