SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Madrigal Pharmaceuticals
MDGL 412.28-1.6%Nov 3 3:59 PM EST

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: Miljenko Zuanic11/15/2018 4:40:52 PM
  Read Replies (1) of 138
 
2017, DEF 14A (goals for year):
By presented, they should have P3 drug quantity and quality in 2017, with final commercial process (3 validation batches) completed. DMF also completed/filled. This is not an easy task for 4 person in R&D, or should be completely paid, by contracts work! 2017 R$D expenditure, however, does not signal to me big bucks, $$$$$?
<Comparison of Years Ended December 31, 2017 and 2016
Our research and development expenses were $24.4 million for the year ended December 31, 2017 compared to $15.9 million for the year ended December 31, 2016. Research and development expenses increased by $8.5 million in the 2017 period due primarily to the expenses incurred to conduct and support the two Phase 2 studies for MGL-3196, which commenced in the fourth quarter of 2016 and the first quarter of 2017, respectively. Our increased research and development expenses include an $8.5 million increase in contract research organization costs directly associated with the two Phase 2 studies. These increases were partially offset by lower stock based compensation expense in 2017, due to the expense incurred in 2016 from the Change in Control Bonus Plan resulting from the Merger.>

I do not know what are objectives for 2018, in regards CMC, but......

The performance objectives, total points possible and total points achieved for 2017 may be summarized as follows:


2017 Corporate Performance Objectives

Total Base
and Bonus
Points

Total Base and Bonus Points Achieved

Research and Development Objectives






Clinical Objectives








Delivery of top-line results for primary endpoint in Phase 2 clinical trial of MGL-3916 in NASH

30

45 (150% achievement of target)



Delivery of top-line results for key secondary endpoints in Phase 2 clinical trial of MGL-3916 in NASH

20

20 (100% achievement of target)



Delivery of top-line results for primary endpoint in Phase 2 clinical trial of MGL-3916 in HeFH

20

20 (100% achievement of target)



Delivery of top-line results for key secondary endpoints in Phase 2 clinical trial of MGL-3916 in HeFH

7.5

0 (less than 75% achievement of target)

Other Research and Development Objectives








Manufacture of drug product for Phase 3 clinical trials

7

10.5 (150% achievement of target)



Development and selection of Phase 3 drug product formulation

5

5 (100% achievement of target)



Achievement of ancillary animal and human studies of MGL-3196 and Metabolite

8

12 (150% achievement of target)



Development of commercial quality drug product

5

5 (100% achievement of target)



Ancillary FDA submissions

5

0 (less than 75% achievement of target)

Finance Objectives








Achievement of financing objectives

15

22.5 (150% achievement of target)



Achievement of financing objectives with blended discount to market price less than specified percentage

5

5 (100% achievement of target)



Manage operating expenditures in accordance with Board approved operating plan

7.5

11.25 (150% achievement of target)

Corporate Development Objectives







Milestones relating to investor/analyst meetings

2.5

3.75 (150% achievement of target)



Milestones relating to analyst coverage

5

7.5 (150% achievement of target)

Total

142.5

167.5
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext