Aegerion Pharma (AEGR) Updates on JUXTAPID, Outlook for FY13
Tweet
Share
E-mailGet Alerts AEGR Hot Sheet
Join SI Premium – FREE
Aegerion Pharmaceuticals, Inc. (Nasdaq: AEGR) announced its business objectives for 2013 in conjunction with the 31st Annual J.P. Morgan Healthcare Conference in San Francisco. Marc Beer, President and Chief Executive Officer, will discuss these objectives as part of a live presentation which will be available on Aegerion's website, www.aegerion.com, on Tuesday, January 8 at 2:00 p.m. PST (5:00 p.m. EST).
"2012 was a year of significant accomplishments for Aegerion culminating with the FDA approval of JUXTAPID in December," said Marc Beer, Chief Executive Officer of Aegerion. "We expect 2013 to be a transformational year for us as a commercial organization as we work to execute on our launch plan and to deliver medicine to patients with homozygous familial hypercholesterolemia (HoFH) in need of treatment."
Mr. Beer continued, "Through our outreach efforts, we continue to identify patients who are potential candidates for therapy and we are well prepared to educate providers about JUXTAPID, and to support patient access. We also plan to make JUXTAPID available on a named patient sale basis in certain of the countries where such sales are permitted based on the U.S. approval. Based on these activities we expect to end 2013 with approximately 250-300 patients on therapy on a global basis, providing a solid base of revenue upon which we expect to build in 2014."
JUXTAPID was approved by the U.S. Food and Drug Administration in December 2012 as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with HoFH.
The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of JUXTAPID have not been established in pediatric patients.
Expanding the Clinical Development Program of JUXTAPID
During the fourth quarter of 2012, Aegerion initiated enrollment of Japanese subjects into a Phase I bridging study of the pharmacokinetic and pharmacodynamic properties of JUXTAPID. Following the outcome of this study, Aegerion plans to conduct a small therapeutic study of JUXTAPID in Japanese HoFH patients in support of a planned filing for marketing authorization in Japan.
As previously disclosed, the FDA has established a post-marketing requirement for Aegerion to conduct a juvenile toxicology study in rodents. The study will seek to ascertain the impact, if any, of JUXTAPID on growth and development prior to initiating a clinical study of JUXTAPID in pediatric patients. Following the completion of the nonclinical study, the company expects to begin a clinical trial in pediatric patients in 2014.
Advancing Regulatory Activities for JUXTAPID
During 2012, Aegerion submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), requesting approval to market lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies, with or without apheresis, to reduce LDL-C, total cholesterol, apolipoprotein B, and triglycerides in adults with HoFH. Aegerion continues to anticipate a European Medicines Agency (EMA) decision in mid-2013. If the application is approved, the company will pursue reimbursement on a country by country basis and anticipates commencing commercial activity in Europe by the end of 2013.
Financial Guidance
Aegerion ended FY 2012 with approximately $78 million to $83 million in cash and cash equivalents. In addition, the Company also announced the following financial guidance:
* Aegerion expects global net revenues of $15 million to $25 million for FY 2013 with 250 to 300 patients on JUXTAPID therapy by year-end 2013.
* 18 months post approval of JUXTAPID in the EU, if approved, the Company expects to:
* generate global net revenue at a $100 million annualized run rate; and
* achieve cash flow breakeven from operations.
*** The Street is looking for FY13 Revs of $23.7 million and a loss of $2.01 per share.
"2012 was a year of significant accomplishments for Aegerion culminating with the FDA approval of JUXTAPID in December," said Marc Beer, Chief Executive Officer of Aegerion. "We expect 2013 to be a transformational year for us as a commercial organization as we work to execute on our launch plan and to deliver medicine to patients with homozygous familial hypercholesterolemia (HoFH) in need of treatment."
Mr. Beer continued, "Through our outreach efforts, we continue to identify patients who are potential candidates for therapy and we are well prepared to educate providers about JUXTAPID, and to support patient access. We also plan to make JUXTAPID available on a named patient sale basis in certain of the countries where such sales are permitted based on the U.S. approval. Based on these activities we expect to end 2013 with approximately 250-300 patients on therapy on a global basis, providing a solid base of revenue upon which we expect to build in 2014."
JUXTAPID was approved by the U.S. Food and Drug Administration in December 2012 as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with HoFH.
The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of JUXTAPID have not been established in pediatric patients.
Expanding the Clinical Development Program of JUXTAPID
During the fourth quarter of 2012, Aegerion initiated enrollment of Japanese subjects into a Phase I bridging study of the pharmacokinetic and pharmacodynamic properties of JUXTAPID. Following the outcome of this study, Aegerion plans to conduct a small therapeutic study of JUXTAPID in Japanese HoFH patients in support of a planned filing for marketing authorization in Japan.
As previously disclosed, the FDA has established a post-marketing requirement for Aegerion to conduct a juvenile toxicology study in rodents. The study will seek to ascertain the impact, if any, of JUXTAPID on growth and development prior to initiating a clinical study of JUXTAPID in pediatric patients. Following the completion of the nonclinical study, the company expects to begin a clinical trial in pediatric patients in 2014.
Advancing Regulatory Activities for JUXTAPID
During 2012, Aegerion submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), requesting approval to market lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies, with or without apheresis, to reduce LDL-C, total cholesterol, apolipoprotein B, and triglycerides in adults with HoFH. Aegerion continues to anticipate a European Medicines Agency (EMA) decision in mid-2013. If the application is approved, the company will pursue reimbursement on a country by country basis and anticipates commencing commercial activity in Europe by the end of 2013.
Financial Guidance
Aegerion ended FY 2012 with approximately $78 million to $83 million in cash and cash equivalents. In addition, the Company also announced the following financial guidance:
* Aegerion expects global net revenues of $15 million to $25 million for FY 2013 with 250 to 300 patients on JUXTAPID therapy by year-end 2013.
* 18 months post approval of JUXTAPID in the EU, if approved, the Company expects to:
* generate global net revenue at a $100 million annualized run rate; and
* achieve cash flow breakeven from operations.
*** The Street is looking for FY13 Revs of $23.7 million and a loss of $2.01 per share.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Atlassian (TEAM) comes ahead of Street estimates in Q1 but shares tumble
- L3Harris Technologies (LHX) Tops Q1 EPS by 15c; raises guidance
- VinFast Auto (VFS) Appoints Tham Chee Soon to its Board, Ngan Wan Sing Winston Resigns
Create E-mail Alert Related Categories
Corporate News, FDA, GuidanceRelated Entities
JPMorganSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
