$AVTX
Avalo Therapeutics, Inc.

2020 Q3 Form 10-Q Financial Statement

#000162828020011892 Filed on August 06, 2020

View on sec.gov

Income Statement

Concept 2020 Q3 2020 Q2 2019 Q2
Revenue $1.111M $1.338M $1.400M
YoY Change -49.53% -4.43% -70.74%
Cost Of Revenue $77.00K $78.00K -$1.497M
YoY Change -41.83% -105.21% -205.18%
Gross Profit $1.034M $1.260M $2.897M
YoY Change -50.02% -56.5% -13.85%
Gross Profit Margin 93.07% 94.17% 206.91%
Selling, General & Admin $5.035M $6.754M $2.666M
YoY Change 76.53% 153.29% -47.55%
% of Gross Profit 486.94% 536.03% 92.05%
Research & Development $8.872M $5.917M $3.713M
YoY Change 408.88% 59.38% 242.9%
% of Gross Profit 858.03% 469.6% 128.17%
Depreciation & Amortization $425.9K $879.0K $1.100M
YoY Change -60.19% -20.1% -11.29%
% of Gross Profit 41.19% 69.76% 37.97%
Operating Expenses $13.91M $12.67M $10.43M
YoY Change 49.08% 21.54% -1.07%
Operating Profit -$13.28M -$11.82M -$2.548M
YoY Change 363.98% 363.68% -55.71%
Interest Expense $0.00 $9.000K $38.41K
YoY Change -100.0% -76.57% -115.85%
% of Operating Profit
Other Income/Expense, Net $19.00K -$1.465M $57.32K
YoY Change -63.95% -2655.74% -124.04%
Pretax Income -$13.26M -$13.28M -$2.491M
YoY Change 372.01% 433.17% -58.42%
Income Tax $3.000K -$500.0K $100.0K
% Of Pretax Income
Net Earnings -$13.46M -$13.28M -$6.223M
YoY Change 235.1% 113.41% 3.59%
Net Earnings / Revenue -1211.43% -992.6% -444.51%
Basic Earnings Per Share
Diluted Earnings Per Share -$179.7K -$211.5K -$1.74
COMMON SHARES
Basic Shares Outstanding 74.90M shares 59.61M shares 42.75M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q3 2020 Q2 2019 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $33.39M $45.39M $9.390M
YoY Change 536.03% 383.39% 330.73%
Cash & Equivalents $33.39M $45.39M $9.387M
Short-Term Investments $0.00 $0.00
Other Short-Term Assets $1.676M $857.4K $900.0K
YoY Change -5.31% -4.74% -6.25%
Inventory $9.060K $12.20K $617.6K
Prepaid Expenses
Receivables $1.671M $2.032M $2.860M
Other Receivables $4.285M $1.953M $140.0K
Total Short-Term Assets $41.03M $50.24M $13.90M
YoY Change 225.94% 261.5% 17.41%
LONG-TERM ASSETS
Property, Plant & Equipment $1.708M $1.741M $1.526M
YoY Change 14.13% 14.08% 2511.99%
Goodwill $14.41M $14.41M $16.41M
YoY Change -12.2% -12.2% -9.18%
Intangibles $1.889M $2.292M $27.63M
YoY Change -92.9% -91.7% -13.66%
Long-Term Investments
YoY Change
Other Assets $148.6K $518.1K $150.0K
YoY Change 48.64% 245.42% -16.67%
Total Long-Term Assets $18.15M $18.96M $45.72M
YoY Change -59.3% -58.53% -9.11%
TOTAL ASSETS
Total Short-Term Assets $41.03M $50.24M $13.90M
Total Long-Term Assets $18.15M $18.96M $45.72M
Total Assets $59.19M $69.20M $59.62M
YoY Change 3.49% 16.07% -4.06%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.927M $2.558M $1.445M
YoY Change 133.16% 76.95% -50.83%
Accrued Expenses $8.811M $6.488M $11.19M
YoY Change -27.66% -42.02% 17.91%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $1.050M
YoY Change 0.0%
Total Short-Term Liabilities $16.57M $14.60M $18.77M
YoY Change -4.0% -22.22% -1.47%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $14.28M
YoY Change -100.0% -100.0% -0.68%
Other Long-Term Liabilities $1.934M $2.032M $1.212M
YoY Change 72.44% 67.58%
Total Long-Term Liabilities $1.934M $2.032M $15.49M
YoY Change -87.42% -86.89% 7.75%
TOTAL LIABILITIES
Total Short-Term Liabilities $16.57M $14.60M $18.77M
Total Long-Term Liabilities $1.934M $2.032M $15.49M
Total Liabilities $20.62M $18.63M $41.92M
YoY Change -47.09% -55.57% -2.33%
SHAREHOLDERS EQUITY
Retained Earnings -$162.1M -$148.7M -$111.9M
YoY Change 39.86% 32.89% 64.42%
Common Stock $74.90K $74.90K $42.90K
YoY Change 69.81% 74.6% 26.95%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $38.57M $50.58M $17.70M
YoY Change
Total Liabilities & Shareholders Equity $59.19M $69.20M $59.62M
YoY Change 3.49% 16.07% -4.06%

Cashflow Statement

Concept 2020 Q3 2020 Q2 2019 Q2
OPERATING ACTIVITIES
Net Income -$13.46M -$13.28M -$6.223M
YoY Change 235.1% 113.41% 3.59%
Depreciation, Depletion And Amortization $425.9K $879.0K $1.100M
YoY Change -60.19% -20.1% -11.29%
Cash From Operating Activities -$11.87M -$14.29M -$6.720M
YoY Change 55.98% 112.71% 1936.36%
INVESTING ACTIVITIES
Capital Expenditures -$62.66K $0.00 $90.00K
YoY Change -100.0% 800.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $11.59M $0.00
YoY Change
Cash From Investing Activities -$62.66K $11.59M -$90.00K
YoY Change -12973.43% 800.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 0.000 44.58M 90.00K
YoY Change -100.0% 49437.24% 125.0%
NET CHANGE
Cash From Operating Activities -11.87M -14.29M -6.720M
Cash From Investing Activities -62.66K 11.59M -90.00K
Cash From Financing Activities 0.000 44.58M 90.00K
Net Change In Cash -11.93M 41.88M -6.720M
YoY Change 191.03% -723.15% 2140.0%
FREE CASH FLOW
Cash From Operating Activities -$11.87M -$14.29M -$6.720M
Capital Expenditures -$62.66K $0.00 $90.00K
Free Cash Flow -$11.81M -$14.29M -$6.810M
YoY Change 55.15% 109.9% 1902.94%

Facts In Submission

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<div style="text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%;">1. Business </span></div><div style="text-align:justify;"><span><br/></span></div><div><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%;">        Cerecor Inc. (the "Company" or "Cerecor") is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies that address unmet patient needs within rare pediatric and orphan diseases. The Company's pediatric rare disease pipeline includes CERC-801, CERC-802 and CERC-803 ("CERC-800 compounds"), which are therapies for inherited metabolic disorders known as Congenital Disorders of Glycosylation ("CDGs"). The U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease Designation ("RPDD") and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of each new drug application ("NDA"). The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-002 is an anti-LIGHT (</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:107%;">L</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%;">ymphotoxin-like, exhibits </span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:107%;">I</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%;">nducible expression, and competes with HSV </span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:107%;">G</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%;">lycoprotein D for </span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:107%;">H</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%;">VEM, a receptor expressed by </span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:107%;">T</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%;"> lymphocytes) monoclonal antibody being developed for the treatment of COVID-19 acute respiratory distress syndrome ("ARDS") and Pediatric-onset Crohn's Disease. CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations and has been granted ODD and RPDD by the FDA, thus potentially qualifying the Company to receive a PRV upon approval of an NDA. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease ("AOSD") and Multiple Myeloma. </span></div><div style="text-align:justify;"><span><br/></span></div><div style="text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        The Company continues to explore strategic alternatives for its commercialized product, Millipred</span><sup style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;vertical-align:top;">®</sup><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">, an oral prednisolone indicated across a wide variety of inflammatory conditions. The Company has been in discussions with Simon Pedder, a former member of its Board of Directors, about potentially transferring its non-core neurology pipeline assets, CERC-301 and CERC-406, to a new company formed by Dr. Pedder, although it has not agreed to binding terms, and any such transaction might not happen until the second half of 2020, if at all. </span></div><div style="text-align:justify;"><span><br/></span></div><div style="text-indent:36pt;text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">On June 11, 2020, the Company closed on an underwritten public offering of 15,180,000 shares of its common stock (inclusive of 1,980,000 shares that were sold pursuant to the underwriter’s full exercise of its option to purchase additional shares of Cerecor’s common stock) for net proceeds of approximately $35.4 million. </span></div><div style="text-indent:36pt;text-align:justify;"><span><br/></span></div><div style="text-indent:36pt;text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">On February 3, 2020, the Company consummated its two-step merger (the "Merger") with Aevi Genomic Medicine, Inc. ("Aevi") in accordance with the terms of the Agreement and Plan of Merger and Reorganization (the "Merger Agreement") dated December 5, 2019. The Merger consideration included stock valued at approximately $15.5 million, resulting in the issuance of approximately 3.9 million shares of Cerecor common stock to Aevi stockholders, forgiveness of a $4.1 million loan that Cerecor loaned Aevi in December 2019 (the "Aevi Loan"), and contingent value rights ("CVRs") for up to an additional $6.5 million in subsequent payments based on development milestones. As part of the Merger, Cerecor acquired the rights to CERC-002, CERC-006 and CERC-007, expanding Cerecor's pipeline to six clinical stage assets being developed for rare pediatric and orphan diseases. Effective upon the consummation of the Merger, Cerecor entered into an employment agreement with Aevi Chief Executive Officer Mike Cola for him to serve as Cerecor's Chief Executive Officer and an employment agreement with Aevi Chief Scientific Officer Dr. Garry Neil for him to serve as Cerecor's Chief Medical Officer, and appointed Mike Cola and Dr. Sol Barer to the Company's Board of Directors. Dr. Neil was promoted to Cerecor's Chief Scientific Officer in March 2020. See Note 6 for more information. </span></div><div style="text-align:justify;"><span><br/></span></div><div style="text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        During the fourth quarter of 2019, the Company entered into, and closed, an asset purchase agreement (the "Aytu Purchase Agreement") with Aytu BioScience, Inc. (“Aytu”) to sell the Company’s rights, title and interest in, assets relating to its pediatric portfolio, namely Aciphex</span><sup style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;vertical-align:top;">® </sup><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">Sprinkle™, Cefaclor for Oral Suspension, Karbinal™ ER, Flexichamber™, Poly-Vi-Flor</span><sup style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;vertical-align:top;">®</sup><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;"> and Tri-Vi-Flor™ (the "Pediatric Portfolio"), as well as the corresponding commercial infrastructure consisting of the right to offer employment to Cerecor’s sales force and the assignment of supporting commercial contracts (the "Aytu Divestiture"). Aytu paid consideration of $4.5 million in cash and approximately 9.8 million shares of Aytu convertible preferred stock (the "Investment"), and assumed certain of the Company’s liabilities, including the Company’s payment obligations payable to Deerfield CSF, LLC of $15.1 million and other liabilities of $11.0 million. The Company recognized a gain of $8.0 million upon the closing of the Aytu Divestiture for the year ended December 31, 2019. As a result of the sale of the Pediatric Portfolio, the Pediatric Portfolio met all conditions required in order to be classified as discontinued operations. Therefore, operating results from the Pediatric Portfolio are reported within income (loss) from discontinued operations, net of tax for all periods presented. In addition, assets and liabilities related to the Pediatric Portfolio are reported as assets and liabilities of discontinued operations in the accompanying condensed consolidated balance sheets as of June 30, 2020 and December 31, 2019. See Note 3 for more information regarding the Aytu Divestiture and its accounting treatment, including the nature of the Company's involvement subsequent to the divestiture. </span></div><div style="text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        Cerecor was incorporated and commenced operation in 2011 and completed its initial public offering in October 2015.</span></div><div style="text-align:justify;"><span><br/></span></div><div style="text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%;">Liquidity</span></div><div style="text-align:justify;"><span><br/></span></div><div style="text-align:justify;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        In June 2020, the Company closed an underwritten public offering of 15,180,000 shares of its common stock (inclusive of 1,980,000 shares that were sold pursuant to the underwriter’s full exercise of its option to purchase additional shares of Cerecor’s common stock) for net proceeds of approximately $35.4 million. In March 2020, the Company entered into a securities purchase agreement with its largest stockholder, Armistice Capital, LLC ("Armistice"), pursuant to which the Company sold 1,951,219 shares of the Company’s common stock for net proceeds of approximately $3.9 million. In February 2020, the Company closed a registered direct offering with institutional investors of 1,306,282 shares of the Company's common stock for net proceeds of approximately $5.1 million. See Note 9 for more information regarding these financings. Additionally, in April 2020, the Company converted its shares of Aytu preferred stock that were acquired in the fourth quarter of 2019 and subsequently sold that common stock, which generated net proceeds of approximately $12.8 million. As of June 30, 2020, Cerecor had $45.4 million in cash and cash equivalents. </span></div><div style="text-align:justify;"><span><br/></span></div><div><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        In order to meet its cash flow needs, the Company applies a disciplined decision-making methodology as it evaluates the optimal allocation of the Company's resources between investing in the Company's existing pipeline assets and acquisitions or in-licensing of new assets. For the six months ended June 30, 2020, Cerecor generated a net loss of $34.4 million and negative cash flow from operations of $14.3 million. As of June 30, 2020, Cerecor had an accumulated deficit of $148.7 million. </span></div><div><span><br/></span></div><div><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern; however, the Company expects to incur additional losses in the future in connection with its research and development activities and will require additional financing to fund its operations and to continue to execute its business strategy. The Company plans to use its current cash on hand, the anticipated cash flows from the Company's profits from Millipred product sales and/or the potential proceeds from a possible out-license or sale of Millipred to a third party to offset costs related to its pipeline assets, business development, and costs associated with its organizational infrastructure; however, Cerecor expects to continue to incur significant expenses and operating losses for the immediate future as it continues to invest in the Company's pipeline assets. The Company’s ability to continue as a going concern is dependent upon the Company’s ability to raise additional equity and/or debt capital, sell assets and/or obtain government funding; however, there can be no assurance that it will be able to do so nor that such activities will generate sufficient amounts, if any, on terms acceptable to the Company.</span></div><div><span><br/></span></div><div><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">        Over the long term, the Company's ultimate ability to achieve and maintain profitability will be dependent on, among other things, the development, regulatory approval, and commercialization of its pipeline assets, and the potential sale of any PRVs it receives, in order to support its cost structure and pipeline asset development.</span></div>        These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements included in this Quarterly Report were issued. To alleviate these conditions, the Company is evaluating the potential out-licensing or sale of Millipred, its non-core neurology pipeline assets and/or some combination of rights to future PRV sales, equity or debt financings, collaborations, other out-licensing arrangements, strategic alliances, federal and private grants, marketing, other distribution or licensing arrangements, or the sale of current or future assets. If the Company raises additional funds through collaborations, strategic alliances or licensing arrangements with third parties, the Company might have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible or suspend or curtail planned programs. Due to the uncertainty regarding future financings and/or other potential options to raise additional funds, management has concluded that substantial doubt exists with respect to the Company’s ability to continue as a going concern within one year after the date that the financial statements in this Quarterly Report were issued.
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