Analyst Conference Summary

biotechnology

conference date: March 12, 2018 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2017 (Q4, fourth quarter 2017)

Forward-looking statements

Overview: Looking forward to two Phase 2 and one Phase 1 clinical clinical trial results in 2018.

Basic data (GAAP):

Revenue was $0.0 million, down sequentially from $0.0 million and down from $0.0 million year-earlier.

Net income from continuing operations was negative $11.8 million, up sequentially from $3.1 million, and up from negative $ million year-earlier.

EPS was negative $0.89, up sequentially from $0.24 and up from negative $ year-earlier.

Guidance:

Cash and anticipated milestones from Shire should be sufficient into the second half of 2019.

[WPM: if Phase 2 results are positive and Phase 3 trials begin, they will need to raise more cash or partner to get to regulatory approval]

Conference Highlights:

Richard Peters, CEO, said "2017 was a transformative year for Merrimack, in which we reset the company's foundation to focus on our ten wholly owned clinical and preclinical programs, all targeting biomarker-defined cancers. We are very pleased with the advancements we have made across our pipeline, including today's announcement to expand enrollment in the SHERLOC study, a randomized Phase 2 trial evaluating MM-121 in non-small cell lung cancer, and our recent dosing of the first patient in the SHERBOC study, a randomized Phase 2 trial evaluating MM-121 in post-menopausal metastatic breast cancer."

A Phase 2 clinical trial of Onivyde for front-line metastatic pancreatic cancer continued enrollment. This could address 46,000 patients annually in the U.S. It could also generate milestone payments from Ipsen if results are positive.

MM-121 (seribantumab) Phase 2 trial (SHERLOC) in non-small cell lung cancer who are heregulin positive continued, with data due in 2H 2018. Retooled the trial into a proof of concept study with a top-line readout in 2H 2018. Received orphan drug designation from the FDA. On March 12, 2018 announced would expand trial from 80 to 100 patients. This was driven by faster-than-expected enrollment, so top line data is still due in 2H 2018.

Phase 2 trial (SHERBOC) of MM-121 plus standard of care (sylvestran) for heregulin positive, hormone receptor positive, HER2 negative breast cancer enrolled its first patient in Q1.

An MM-141 Phase 2 clinical trial completed enrollment in June for frontline pancreatic cancer who have high serum IGF-1 levels, in combination with existing therapies. It is a bispecific antibody. Blocks two upstream redundant pathways. Expects topline results in first half of 2018 with progression free survival as the primary endpoint. About 50% of pancreatic cancers display high IGF-1.

MM-310 is an antibody directed nanoliposome targeting the EphA2 receptor, which is present in many major tumor types. Delivers docetaxel as a prodrug. Initiated the Phase 1 trial in a variety of solid tumors with a dosing schedule result expected in 2H 2018. Believes will reduce toxicity.

Merrimack has other compounds in preclinical development. It is a biomarker-driven approach.

Formed a Scientific Advisory Board in the quarter.

Merrimack plans to seek partners for the development of its therapies once proof-of-concept has been established. Merrimack has a total of 10 drugs with clinical or preclinical status.

See also the Merrimack Pipeline.

In October settled the Ipsen litigation (triggered by the Ipsen purchase of Onivyde, but not vs. Ipsen), agreeing to pay $0.90 per $1.00 of 4.5% convertible notes plus interest and legal fees. Also is tendering for all remaining notes at the $0.90 rate. Total cost $60 million. Could eliminate all remaining debt.

Cash and equivalents ended at $93.4 million, down sequentially from $107.2 million. No debt, as convertible debt was extinguished in Q4.

Costs and expenses were $17.1 million, consisting of: $0.0 million cost of goods sold, $12.4 million for R&D; and $4.7 million for selling, general and administrative expense. Operating profit was negative $ million. Other expenses (mainly interest) were $ million. Income tax . Net loss from continuing operations was $11.8 million.

For the full year 2017 the net loss from continuing operations was $74.8 million or $5.66 per share. Including $547 million income from discontinued operations, net income was $472 million or $35.67 per share.

Q&A:

121 Sherloc study, 4Q now? Cannot predict where within 2H because it is an event-driven trial. There is great interest from investigators and shows the incredible medical need.

Mature PFS in topline Sherloc study? 0.05 at 80% power assuming 6 months vs. 3 months control arm. [seemed to say not all 100 patients enrolled yet, but soon]

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