Executive Summary

Q4 2014 was a clean, pre-revenue quarter with net loss of $7.4M and loss per share of $0.40, improving sequentially versus Q3 ($27.2M; $1.53) and Q2 ($19.4M; $2.55), driven by the absence of prior one-time items (e.g., $22M MIN-202 license fee in Q3) .
R&D expense was $3.0M in Q4 vs the CFO’s Q3 commentary indicating $4–$5M expected, reflecting lower-than-anticipated spend; G&A was $4.5M (vs $2.4M in Q3) as public company costs scaled .
Pipeline progressed: regulatory/ethics approvals received for MIN-101 Phase 2b (Latvia/Estonia), with enrollment over the last three quarters of 2015 and top-line data targeted for mid-2016 (Q2) .
Balance sheet strengthened: $18.6M cash at year-end, plus $10M term loan in January and ~$28.8M private placement in March; management expects cash to fund operations through 2016, extending prior guidance (“through end of 2015”) .
S&P Global Wall Street consensus (EPS, revenue) for Q4 2014 was unavailable in our pull; treat the quarter as “no estimates” for beat/miss framing (consensus unavailable via S&P Global).

What Went Well and What Went Wrong

What Went Well

Regulatory momentum: “received regulatory approval in Latvia, and ethical committee approvals in Latvia and Estonia, for the Phase 2b study for MIN-101,” with clear trial design and endpoints .
Strengthened liquidity runway: cash $18.6M at 12/31/14; $10M term loan in January and ~$28.8M equity/warrants in March; “current cash will fund the Company’s operations through 2016” .
Portfolio breadth and milestones: CEO emphasized “we expect to initiate four clinical studies in 2015 with milestones in late 2015 through mid 2016,” including two MIN-202 studies and a MIN-117 Phase 2a start .

What Went Wrong

Timing slip on MIN-101 enrollment: prior plan to begin enrollment in 1H15 shifted to “enrollment… over the last three quarters of 2015,” implying schedule push .
Elevated G&A reflecting public company scale: Q4 G&A was $4.5M vs $2.4M in Q3 and $3.1M in Q2, driven by staffing and public company costs .
Prior quarters included large non-recurring charges that obscured underlying spend trajectory (e.g., Q3 $22.0M MIN-202 license fee; Q2 ~$14.5M non-cash stock comp), highlighting volatility in quarterly P&L and complicating trend analysis .

Financial Results

P&L summary by quarter

Metric	Q2 2014	Q3 2014	Q4 2014
Revenues ($USD Millions)	$0.0	$0.0	$0.0 (Company reported $0 revenue for FY2014)
R&D Expense ($USD Millions)	$14.6	$24.7	$3.0
G&A Expense ($USD Millions)	$3.1	$2.4	$4.5
Net Loss ($USD Millions)	$19.4	$27.2	$7.4
Loss per Share ($USD)	$2.55	$1.53	$0.40

Notes: Q3 R&D included a one-time $22.0M license fee for MIN-202; Q2 included ~$14.5M non-cash stock-based compensation .

Revenue and EPS vs estimates

Metric	Q2 2014	Q3 2014	Q4 2014
Revenue Actual ($USD Millions)	$0.0	$0.0	$0.0
Revenue S&P Global Consensus ($USD Millions)	N/A – unavailable	N/A – unavailable	N/A – unavailable
EPS Actual ($USD)	$(2.55)	$(1.53)	$(0.40)
EPS S&P Global Consensus ($USD)	N/A – unavailable	N/A – unavailable	N/A – unavailable

Margins: Not meaningful for a pre-revenue clinical-stage company (gross margin, EBITDA margin not applicable) .

Balance sheet and financing

Metric	Q2 2014	Q3 2014	Q4 2014
Cash & Cash Equivalents ($USD Millions)	$0.5	$23.6	$18.6
Subsequent Events (post-Q)	IPO/private placements completed in July; $29.9M net; $19.7M gross from Janssen; $22.0M license fee to Janssen	—	$10.0M term loan draw (Jan 2015); ~$28.8M private placement (Mar 2015); runway through 2016

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Corporate	“Sufficient… through end of 2015” (post-IPO and private placements)	“Fund operations through 2016” (post loan and private placement)	Raised/extended
MIN-101 Phase 2b enrollment start/pace	2015	Submit in 4Q14; enrollment to begin in 1H15	Enrollment over the last three quarters of 2015; complete by YE15	Delayed/paced later in year
MIN-101 top-line timing	2016	First half of 2016	Mid-2016, specifically Q2 2016	Narrowed/specified
MIN-202 trials	2014–2015	Phase 1 bioavailability 4Q14; Phase 1b and MAD results 1Q15	Two additional studies (Phase 2a primary insomnia; Phase 1b in MDD with insomnia) to initiate mid-2015	Expanded program scope
MIN-117 Phase 2a	2015	Program referenced earlier-stage; no quarter-specific start	Ethics approval in Latvia; enrollment expected in Q2 2015	New/initiated
MIN-301 IND/IMPD	2016	Preclinical updates underway; no IND date	IND/IMPD expected in 2016; Phase 1 thereafter	New timing disclosed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2, Q3)	Current Period (Q4 2014)	Trend
MIN-101 formulation and Phase 2b design	Once-daily formulation study with topline expected 4Q14; Phase 2b submission planned 4Q14; enrollment 1H15	Regulatory/ethics approvals secured; enrollment over last 3 quarters of 2015; topline mid-2016; trial design and endpoints reiterated	Progress with modest schedule push; higher clarity on timelines
MIN-202 insomnia program (Janssen co-dev)	IND accepted; bioavailability study 4Q14; Phase 1b and MAD results 1Q15	Preliminary Phase 1 data showed significant improvements in sleep onset/duration in MDD-related insomnia; two studies to initiate mid-2015	Evidence building; program expanding into Phase 2a
MIN-117 (MDD)	Added via prior transactions; dose-finding rationale emphasized	Ethics approval for Phase 2a (60 pts); starting Q2 2015; 0.5 mg dose rationale (safety, cognition/sexual function) elaborated	Advancing to Phase 2a with clear low-dose strategy
MIN-301 (Parkinson’s)	Pipeline candidate; preclinical work noted	Positive non-human primate data; IND/IMPD targeted in 2016; Phase 1 thereafter	De-risking preclinical; pathway to first-in-human
Financing/cash runway	IPO/private placements funded operations through end-2015	Term loan ($10M) and private placement (~$28.8M) extend runway through 2016	Strengthened liquidity; longer runway

Management Commentary

CEO: “We are very pleased to report continued progress for each of our clinical development programs… following our recent private placement… we now have… resources to progress toward our goal of building a company with innovative therapeutics…” .
CEO: “We expect to initiate four clinical studies in 2015 with milestones in late 2015 through mid 2016.” .
CFO: “Cash and cash equivalents as of December 31, 2014 were $18.6 million… term loan… $10 million… raised net proceeds of approximately $28.8 million… Our current cash is anticipated to fund our operations through 2016…” .
CEO (MIN-101 trial specifics): “Two doses… 32 mg and 64 mg… 234 stable schizophrenic patients… primary endpoint: negative symptoms via PANSS; BNSS also applied” .

Q&A Highlights

MIN-101 enrollment timeline and data timing: Management expects enrollment to occur over the final three quarters of 2015, complete by YE15; last patients’ 3-month treatment pushes top-line into mid-2016 (Q2) .
MIN-101 powering assumptions: Based on Phase 2a, expected difference vs placebo on negative symptoms is 3.5 points with 90% power on the primary endpoint (PANSS negative symptoms) .
MIN-117 dose selection: 0.5 mg chosen based on preclinical/clinical pharmacology indicating efficacy at very low doses and prioritizing safety, cognition, and sexual function; chronic treatment safety emphasized .

Estimates Context

We attempted to retrieve S&P Global consensus for Q2–Q4 2014 (EPS and revenue), but data were unavailable in our pull; treat Q4 2014 as “no published consensus” for beat/miss framing. As a clinical-stage, pre-revenue micro-cap in 2014, formal coverage may have been limited.
Implication: No beat/miss determination versus Street; focus should remain on OpEx trajectory, cash runway, and clinical milestones .

Key Takeaways for Investors

Sequential P&L improvement: Q4 net loss per share of $0.40 reflects normalization after Q3 one-time license fee and Q2 non-cash comp; watch OpEx cadence as programs ramp in 2015 .
R&D spend came in below the CFO’s Q3 indication ($3.0M vs $4–$5M), suggesting disciplined spending or timing shifts; monitor Q1/Q2 2015 as trials initiate .
Liquidity extended through 2016 via debt and equity; this de-risks near-term funding around four planned studies and late-2015/2016 readouts .
MIN-101 is the primary value driver: regulatory/ethics approvals in Europe, clear design/endpoints, and powering assumptions; any enrollment/operational execution updates are trading catalysts .
MIN-202 shows objective sleep benefits and expands into Phase 2a/1b; Janssen partnership reduces development risk and supports broader insomnia opportunity .
Additional optionality from MIN-117 (Phase 2a start Q2 2015) and MIN-301 (IND/IMPD in 2016) diversifies pipeline risk .
Near-term focus: trial initiations/enrollment progress, clarity on site activation pace, and any incremental financing signals; medium-term thesis hinges on MIN-101 negative symptom efficacy and clean safety, with potential for broader neuropsychiatric applications .

Minerva Neurosciences, Inc. (NERV)·Q4 2014 Earnings Summary