Chimerix(CMRX) - 2018 Q4 - Annual Report

PART I Business Overview Chimerix develops and commercializes medicines for immunocompromised patients, focusing on brincidofovir for DNA viruses with proprietary lipid conjugate technology - Chimerix is a biopharmaceutical company focused on discovering, developing, and commercializing medicines for immunocompromised patients, utilizing its proprietary lipid conjugate technology13 39 40 - The lead compound, brincidofovir (BCV), is in development as oral and intravenous (IV) formulations for the prevention and treatment of DNA viruses, including smallpox, adenovirus (AdV), and human herpesviruses13 15 - Brincidofovir has received orphan designations from the European Commission for AdV infection, CMV disease prevention, and smallpox treatment, and from the U.S. FDA for smallpox treatment, offering potential market exclusivity18 - The AdAPT study for oral BCV in pediatric HCT recipients with AdV infection is experiencing significant enrollment delays beyond 2019 due to regulatory hurdles, site initiation delays, and lower-than-anticipated incidence23 Oral Brincidofovir for Smallpox Treatment: Rabbitpox Efficacy Study Results (January 2019) | Treatment Group | Overall Survival | P-value vs. No treatment (placebo) | |:-------------------------------|:-----------------|:-----------------------------------| | BCV treatment 3 days postinfection | 29/29 (100%) | <0.0001 | | BCV treatment 4 days postinfection | 26/29 (90%) | <0.0001 | | BCV treatment 5 days postinfection | 20/29 (69%) | 0.0014 | | BCV treatment 6 days postinfection | 20/29 (69%) | 0.0014 | | No treatment (placebo) | 8/28 (29%) | 0 | - The norovirus research and development program for CMX521 has been paused indefinitely due to the need for improved intracellular delivery before efficacy studies37 - The company relies on third-party manufacturers for drug substance and product supply for clinical trials and commercial purposes, with a single qualified firm for drug substance currently85 87 - The company's worldwide patent portfolio includes 123 patents/applications related to brincidofovir and CMX157, with composition of matter coverage for brincidofovir in the U.S. expected to extend to October 203480 82 Chimerix Overview Brincidofovir CMX521 for Norovirus CMX157 Lipid Conjugate Technology and Our Chemical Library Evaluation of External Opportunities to Strengthen our Pipeline Significant Agreements Commercial Operations Competition Our Intellectual Property Manufacturing Government Regulation and Product Approval Environmental, Health and Safety Regulations Employees Corporate Information Risk Factors The company faces significant risks including substantial historical losses, the need for additional capital, and uncertain regulatory approval for its lead candidate brincidofovir - Chimerix has incurred significant net losses since inception, totaling approximately $556.3 million as of December 31, 2018, and anticipates continued losses for the foreseeable future166 Net Losses (2016-2018) | Year Ended December 31 | Net Loss (in millions) | |:-----------------------|:-----------------------| | 2018 | $69.5 | | 2017 | $71.0 | | 2016 | $76.4 | - The company's ability to generate future revenues is uncertain and depends on successfully developing, obtaining regulatory approval for, and commercializing product candidates, particularly brincidofovir173 174 - Clinical trials for brincidofovir, including the AdAPT study and Phase 2 IV BCV studies, have experienced regulatory and site initiation delays, leading to slower-than-expected enrollment176 216 - The company relies on third-party manufacturers for drug supplies and CROs for clinical studies, which introduces risks related to quality, capacity, compliance, and potential delays254 256 269 - Commercial success depends on market acceptance by physicians, patients, and payers, which is influenced by clinical safety/efficacy, convenience, price, and competition from existing and developing therapies275 276 - The company's intellectual property protection, relying on patents and trade secrets, is subject to challenges, potential infringement claims, and varying protection levels in foreign countries312 313 314 - Future revenues for smallpox treatment development are highly dependent on the BARDA contract, which is subject to government discretion, budget changes, and potential termination331 334 - The resignation of the former CEO and the creation of the Office of the Chief Executive Officer may cause operational disruptions, employee turnover, and changes in business strategy374 375 Unresolved Staff Comments There are no unresolved staff comments from the SEC - No unresolved staff comments were reported406 Properties Chimerix's corporate headquarters and laboratory spaces are leased in Durham, North Carolina, with leases expiring in 2021 - Corporate headquarters: 2505 Meridian Parkway, Suite 100, Durham, North Carolina, 24,862 sq ft, lease expires February 2021407 - Laboratory space: Durham and Research Triangle Park, North Carolina, 10,274 sq ft total, leases expire July 2021 and August 2021407 Legal Proceedings The company has no material legal proceedings to report - No legal proceedings were reported409 Mine Safety Disclosures Mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable410 PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Chimerix's common stock trades on The Nasdaq Global Market, has experienced volatility, and the company has never paid cash dividends - Chimerix common stock began trading on The Nasdaq Global Market on April 11, 2013, under the symbol 'CMRX'413 Common Stock High and Low Sales Prices (2017-2018) | Period | 2018 High ($) | 2018 Low ($) | 2017 High ($) | 2017 Low ($) | |:-----------------|:--------------|:-------------|:--------------|:-------------| | First Quarter | 5.94 | 4.58 | 6.64 | 4.33 | | Second Quarter | 5.22 | 4.35 | 6.57 | 4.28 | | Third Quarter | 5.04 | 3.57 | 5.60 | 4.30 | | Fourth Quarter | 4.00 | 2.08 | 5.54 | 4.17 | - As of February 26, 2019, there were 33 stockholders of record for the common stock419 - The company has never declared or paid cash dividends and intends to retain all available funds and future earnings for business operations and growth420 - No unregistered securities were sold, and no equity securities were purchased by the issuer during the period covered by this report421 423 Selected Financial Data This section presents selected consolidated financial data for Chimerix, Inc., highlighting consistent net losses and fluctuations in financial position from 2014 to 2018 Consolidated Statement of Operations and Comprehensive Loss Data (2014-2018, in thousands) | Metric | 2018 | 2017 | 2016 | 2015 | 2014 | |:-----------------------------------------|:------------|:------------|:------------|:--------------|:------------| | Contract revenue | $7,216 | $4,494 | $5,702 | $9,214 | $4,040 | | Collaboration and licensing revenue | — | — | — | $1,548 | — | | Total revenues | $7,216 | $4,494 | $5,702 | $10,762 | $4,040 | | Research and development expenses | $55,239 | $49,448 | $58,647 | $97,717 | $45,379 | | General and administrative expenses | $23,582 | $27,148 | $25,007 | $31,296 | $17,527 | | Total operating expenses | $78,821 | $76,596 | $83,654 | $129,013 | $62,906 | | Loss from operations | $(71,605) | $(72,102) | $(77,952) | $(118,251) | $(58,866) | | Unrealized loss on equity investment | $(348) | $(1,160) | — | — | — | | Interest income (expense) and other, net | $2,479 | $2,278 | $1,562 | $879 | $(446) | | Net loss | $(69,474) | $(70,984) | $(76,390) | $(117,372) | $(59,312) | | Net loss per share, basic and diluted | $(1.43) | $(1.51) | $(1.65) | $(2.67) | $(1.80) | | Weighted-average shares outstanding | 48,593,435 | 46,963,430 | 46,267,064 | 43,878,326 | 33,003,714 | Consolidated Balance Sheet Data (2014-2018, in thousands) | Metric | 2018 | 2017 | 2016 | 2015 | 2014 | |:-------------------------------------|:--------------|:--------------|:--------------|:--------------|:--------------| | Cash and cash equivalents | $81,106 | $18,548 | $51,463 | $20,605 | $128,462 | | Short-term investments | $105,424 | $132,972 | $180,558 | $199,729 | $106,114 | | Working capital | $176,492 | $143,337 | $226,360 | $208,658 | $220,390 | | Long-term investments | — | $76,731 | $47,407 | $124,040 | $52,973 | | Total assets | $190,714 | $235,230 | $286,770 | $355,992 | $291,878 | | Accumulated deficit | $(556,262) | $(486,788) | $(415,804) | $(339,414) | $(222,042) | | Total stockholders' equity (deficit) | $177,604 | $221,810 | $276,224 | $335,459 | $274,636 | Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes Chimerix's financial condition and operations, detailing brincidofovir development delays, the CMX521 program pause, ongoing net losses, and funding reliance on government contracts and equity offerings - The AdAPT study for oral brincidofovir in pediatric HCT recipients with AdV infection is experiencing substantial enrollment delays beyond 2019 due to regulatory and site initiation issues, and lower-than-anticipated incidence433 Oral Brincidofovir for Smallpox Treatment: Rabbitpox Efficacy Study Results (January 2019) | Treatment Group | Overall Survival | P-value vs. No treatment (placebo) | |:-------------------------------|:-----------------|:-----------------------------------| | BCV treatment 3 days postinfection | 29/29 (100%) | <0.0001 | | BCV treatment 4 days postinfection | 26/29 (90%) | <0.0001 | | BCV treatment 5 days postinfection | 20/29 (69%) | 0.0014 | | BCV treatment 6 days postinfection | 20/29 (69%) | 0.0014 | | No treatment (placebo) | 8/28 (29%) | 0 | - IV brincidofovir has progressed to Phase 2 studies in adult allogeneic HCT recipients with AdV, with data expected to inform future Phase 2/3 studies, but these studies also face regulatory and enrollment delays439 - The CMX521 norovirus research and development program has been paused indefinitely due to the need for improved intracellular delivery442 Revenue Comparison (2017 vs. 2018, in thousands) | Metric | 2018 | 2017 | Change | % Change | |:---------------|:-------|:-------|:-------|:---------| | Contract revenue | $7,216 | $4,494 | $2,722 | 60.6% | Research and Development Expenses Comparison (2017 vs. 2018, in thousands) | Metric | 2018 | 2017 | Change | % Change | |:--------------------------------------------------------------------|:--------|:--------|:-------|:---------| | Research and development | $55,239 | $49,448 | $5,791 | 11.7% | | Increase in oral brincidofovir clinical expenses | | | $3,200 | | | Increase in oral brincidofovir smallpox program expenses | | | $2,700 | | | Increase in supporting R&D expenses | | | $1,700 | | | Increase related to IV brincidofovir development | | | $800 | | | Decrease related to compensation expense | | | $(1,500)| | | Decrease of development costs related to CMX521 | | | $(1,300)| | General and Administrative Expenses Comparison (2017 vs. 2018, in thousands) | Metric | 2018 | 2017 | Change | % Change | |:-------------------------------------|:--------|:--------|:--------|:---------| | General and administrative | $23,582 | $27,148 | $(3,566)| (13.1)% | | Decrease related to compensation expense | | | $(2,300)| | | Decrease in costs related to indemnification claim | | | $(1,000)| | | Decrease in global commercial readiness costs | | | $(300) | | Net Cash Flows (2016-2018, in thousands) | Cash Flow Activity | 2018 | 2017 | 2016 | |:-----------------------------------|:------------|:------------|:------------| | Net cash used in operating activities | $(53,725) | $(50,125) | $(63,815) | | Net cash provided by investing activities | $105,095 | $16,431 | $94,065 | | Net cash provided by financing activities | $11,188 | $779 | $608 | | Net increase (decrease) in cash and cash equivalents | $62,558 | $(32,915) | $30,858 | - The company believes existing cash, cash equivalents, and short-term investments will fund operations for at least the next 12 months, but substantial additional funding will be required for continued development and commercialization507 517 Overview Recent Developments Financial Overview Critical Accounting Policies and Significant Judgments and Estimates RESULTS OF OPERATIONS LIQUIDITY AND CAPITAL RESOURCES CONTRACTUAL OBLIGATIONS AND COMMITMENTS Off-Balance Sheet Arrangements Quantitative and Qualitative Disclosures About Market Risk Chimerix's market risk exposure is primarily interest income sensitivity, which is not expected to materially impact financial results, and inflation has not had a material effect - Primary market risk is interest income sensitivity, but an immediate 10.0% change in interest rates is not expected to materially affect the fair market value of the investment portfolio, operating results, or cash flows525 - The company does not believe its cash, cash equivalents, and available-for-sale investments have significant risk of default or illiquidity, despite holding amounts exceeding federally insured limits526 - Inflation has not had a material effect on the company's results of operations for the years ended December 31, 2018 or 2017527 Financial Statements and Supplementary Data This section includes Chimerix's audited consolidated financial statements, comprising balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes and unaudited quarterly data - The section includes the Reports of Independent Registered Public Accounting Firm, affirming the fair presentation of financial statements and effective internal control over financial reporting532 533 540 Consolidated Balance Sheets (December 31, 2018 and 2017, in thousands) | Asset/Liability/Equity | 2018 ($) | 2017 ($) | |:-----------------------------------|:------------|:------------| | ASSETS | | | | Cash and cash equivalents | 81,106 | 18,548 | | Short-term investments | 105,424 | 132,972 | | Accounts receivable | 330 | 1,682 | | Prepaid expenses and other current assets | 2,598 | 3,331 | | Total current assets | 189,458 | 156,533 | | Long-term investments | — | 76,731 | | Property and equipment, net | 1,210 | 1,894 | | Other long-term assets | 46 | 72 | | Total assets | 190,714 | 235,230 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Accounts payable | 4,691 | 3,812 | | Accrued liabilities | 8,275 | 9,384 | | Total current liabilities | 12,966 | 13,196 | | Lease-related obligations | 144 | 224 | | Total liabilities | 13,110 | 13,420 | | Common stock | 51 | 47 | | Additional paid-in capital | 733,907 | 709,514 | | Accumulated other comprehensive loss, net | (92) | (963) | | Accumulated deficit | (556,262) | (486,788) | | Total stockholders' equity | 177,604 | 221,810 | | Total liabilities and stockholders' equity | 190,714 | 235,230 | Consolidated Statements of Operations and Comprehensive Loss (2016-2018, in thousands) | Metric | 2018 ($) | 2017 ($) | 2016 ($) | |:-----------------------------------------|:------------|:------------|:------------| | Contract revenue | 7,216 | 4,494 | 5,702 | | Research and development | 55,239 | 49,448 | 58,647 | | General and administrative | 23,582 | 27,148 | 25,007 | | Total operating expenses | 78,821 | 76,596 | 83,654 | | Loss from operations | (71,605) | (72,102) | (77,952) | | Unrealized loss on equity investment | (348) | (1,160) | — | | Interest income and other, net | 2,479 | 2,278 | 1,562 | | Net loss | (69,474) | (70,984) | (76,390) | | Unrealized gain (loss) on investments, net | 871 | (523) | 324 | | Comprehensive loss | (68,603) | (71,507) | (76,066) | | Net loss, basic and diluted per share | (1.43) | (1.51) | (1.65) | | Weighted-average shares outstanding | 48,593,435 | 46,963,430 | 46,267,064 | Consolidated Statements of Cash Flows (2016-2018, in thousands) | Cash Flow Activity | 2018 ($) | 2017 ($) | 2016 ($) | |:-----------------------------------|:------------|:------------|:------------| | Net cash used in operating activities | (53,725) | (50,125) | (63,815) | | Net cash provided by investing activities | 105,095 | 16,431 | 94,065 | | Net cash provided by financing activities | 11,188 | 779 | 608 | | Net increase (decrease) in cash and cash equivalents | 62,558 | (32,915) | 30,858 | | Cash and cash equivalents, beginning of period | 18,548 | 51,463 | 20,605 | | Cash and cash equivalents, end of period | 81,106 | 18,548 | 51,463 | - The company has an accumulated deficit of $556.3 million as of December 31, 2018, and has recorded a full valuation allowance against its net deferred tax assets due to a history of losses504 645 Reports of Independent Registered Public Accounting Firm Consolidated Balance Sheets as of December 31, 2018 and 2017 Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2018, 2017 and 2016 Consolidated Statements of Stockholders' Equity (Deficit) for the Years Ended December 31, 2018, 2017 and 2016 Consolidated Statements of Cash Flows for the Years Ended December 31, 2018, 2017 and 2016 Notes to Consolidated Financial Statements Changes in and Disagreements With Accountants on Accounting and Financial Disclosure There have been no changes in or disagreements with accountants on accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure were reported678 Controls and Procedures Chimerix's disclosure controls and internal control over financial reporting were deemed effective as of December 31, 2018, with an unqualified opinion from Ernst & Young LLP - As of December 31, 2018, disclosure controls and procedures were deemed effective679 - Management concluded that internal control over financial reporting was effective as of December 31, 2018, based on the COSO 2013 framework683 - Ernst & Young LLP issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting684 - No material changes in internal control over financial reporting occurred during the last fiscal quarter685 Other Information There is no other information to report in this section - No other information was reported686 PART III Directors, Executive Officers and Corporate Governance Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's 2019 Annual Meeting of Stockholders Proxy Statement - Information on directors, executive officers, and corporate governance is incorporated by reference from the 2019 Proxy Statement689 - The company has adopted a Code of Business Conduct and Ethics, available on its website, and will disclose any amendments or waivers for specified officers690 Executive Compensation Details on executive compensation are incorporated by reference from the company's 2019 Annual Meeting of Stockholders Proxy Statement - Executive compensation information is incorporated by reference from the 2019 Proxy Statement691 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information concerning security ownership of certain beneficial owners and management, as well as related stockholder matters, is incorporated by reference from the company's 2019 Annual Meeting of Stockholders Proxy Statement - Information on security ownership of certain beneficial owners and management is incorporated by reference from the 2019 Proxy Statement692 Certain Relationships and Related Transactions, and Director Independence Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's 2019 Annual Meeting of Stockholders Proxy Statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2019 Proxy Statement693 Principal Accounting Fees and Services Information on principal accounting fees and services is incorporated by reference from the company's 2019 Annual Meeting of Stockholders Proxy Statement - Information on principal accounting fees and services is incorporated by reference from the 2019 Proxy Statement694 PART IV Exhibits, Financial Statement Schedules This section lists all exhibits and financial statement schedules filed as part of the Annual Report on Form 10-K, confirming the inclusion of financial statements and an exhibit index - Financial statements and reports of independent registered public accounting firm are filed as part of this Annual Report697 - No financial statement schedules are included as the information is either provided in the consolidated financial statements, not required, or immaterial698 - A comprehensive exhibit index is provided, detailing various corporate documents, agreements, and certifications699