2023 Q1 Form 10-K Financial Statement

#000143922223000039 Filed on February 23, 2023

View on sec.gov

Income Statement

Concept 2023 Q1 2022 Q4 2022
Revenue $5.609M $4.310M $14.24M
YoY Change 574.16%
Cost Of Revenue $554.0K $413.0K $1.704M
YoY Change 63.42%
Gross Profit $5.055M $3.897M $12.54M
YoY Change 925.35%
Gross Profit Margin 90.12% 90.42% 88.03%
Selling, General & Admin $28.37M $32.77M $121.7M
YoY Change -9.99% 3.94% 0.19%
% of Gross Profit 561.17% 840.93% 970.59%
Research & Development $67.30M $70.30M $279.9M
YoY Change -4.02% -4.09% 8.93%
% of Gross Profit 1331.37% 1803.9% 2232.85%
Depreciation & Amortization $1.790M $1.814M $8.400M
YoY Change -27.76% -17.62% -4.55%
% of Gross Profit 35.41% 46.55% 67.01%
Operating Expenses $95.67M $103.1M $401.6M
YoY Change 36.43% -1.68% 6.12%
Operating Profit -$90.61M -$99.17M -$389.0M
YoY Change -10.41% 2.81%
Interest Expense $8.091M $6.488M $12.79M
YoY Change 1065.85% 1854.22% 1430.26%
% of Operating Profit
Other Income/Expense, Net $1.504M $1.357M $6.749M
YoY Change -49.41% -58.48% -53.24%
Pretax Income -$81.02M $36.53M -$231.8M
YoY Change -14.51% -137.05% -34.98%
Income Tax
% Of Pretax Income
Net Earnings -$81.02M $36.53M -$231.8M
YoY Change -14.51% -138.6% -114.44%
Net Earnings / Revenue -1444.43% 847.47% -1627.82%
Basic Earnings Per Share -$1.47 -$4.23
Diluted Earnings Per Share -$1.47 $0.66 -$4.23
COMMON SHARES
Basic Shares Outstanding 55.29M shares 54.94M shares 54.79M shares
Diluted Shares Outstanding 55.27M shares 54.79M shares

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $739.2M $783.1M $783.1M
YoY Change -19.96% -23.22% -23.22%
Cash & Equivalents $104.1M $139.3M $139.3M
Short-Term Investments $635.1M $643.9M $643.9M
Other Short-Term Assets $39.30M $38.96M $38.96M
YoY Change -9.08% -2.21% -2.21%
Inventory $11.37M $8.492M $8.492M
Prepaid Expenses
Receivables $1.778M $2.206M $2.206M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $791.7M $832.8M $832.8M
YoY Change -18.82% -21.75% -21.75%
LONG-TERM ASSETS
Property, Plant & Equipment $21.44M $22.99M $88.12M
YoY Change -26.57% -20.52% -15.46%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $271.7M $313.9M $313.9M
YoY Change 6.21% 17.83% 17.83%
Other Assets $3.956M $3.956M $3.956M
YoY Change 36.41% 36.41% 36.41%
Total Long-Term Assets $359.6M $405.9M $405.9M
YoY Change -0.3% 8.69% 8.69%
TOTAL ASSETS
Total Short-Term Assets $791.7M $832.8M $832.8M
Total Long-Term Assets $359.6M $405.9M $405.9M
Total Assets $1.151B $1.239B $1.239B
YoY Change -13.82% -13.84% -13.84%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $8.662M $18.62M $18.62M
YoY Change -25.01% 11.47% 11.47%
Accrued Expenses $22.46M $30.35M $44.01M
YoY Change 13.73% -5.06% 2.85%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00 $0.00
YoY Change -100.0% -100.0%
Total Short-Term Liabilities $45.11M $62.63M $62.63M
YoY Change -1.48% 4.69% 4.69%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change -100.0% -100.0% -100.0%
Other Long-Term Liabilities $1.313M $3.279M $75.28M
YoY Change -98.41% 1088.04% -12.12%
Total Long-Term Liabilities $1.313M $3.279M $75.28M
YoY Change -98.41% 1088.04% -12.4%
TOTAL LIABILITIES
Total Short-Term Liabilities $45.11M $62.63M $62.63M
Total Long-Term Liabilities $1.313M $3.279M $75.28M
Total Liabilities $114.8M $137.9M $137.9M
YoY Change -10.62% -5.39% -5.39%
SHAREHOLDERS EQUITY
Retained Earnings -$551.6M -$470.6M
YoY Change 65.37% 97.09%
Common Stock $2.399B $2.386B
YoY Change 2.03% 2.22%
Preferred Stock
YoY Change
Treasury Stock (at cost) $802.5M $802.5M
YoY Change 0.0% 0.0%
Treasury Stock Shares 16.22M shares 16.22M shares
Shareholders Equity $1.037B $1.101B $1.101B
YoY Change
Total Liabilities & Shareholders Equity $1.151B $1.239B $1.239B
YoY Change -13.82% -13.84% -13.84%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$81.02M $36.53M -$231.8M
YoY Change -14.51% -138.6% -114.44%
Depreciation, Depletion And Amortization $1.790M $1.814M $8.400M
YoY Change -27.76% -17.62% -4.55%
Cash From Operating Activities -$95.18M -$66.16M -$309.5M
YoY Change -2.61% -21.32% -24.02%
INVESTING ACTIVITIES
Capital Expenditures $399.0K $113.0K $4.881M
YoY Change -85.77% -102.51% -14.98%
Acquisitions
YoY Change
Other Investing Activities $58.00M $83.06M $248.1M
YoY Change -343.99% -192.38% -80.22%
Cash From Investing Activities $57.60M $82.95M $243.3M
YoY Change -316.75% -187.85% -80.52%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $2.467M 22.00K $2.350M
YoY Change 104.22% -100.12% -100.31%
NET CHANGE
Cash From Operating Activities -$95.18M -66.16M -$309.5M
Cash From Investing Activities $57.60M 82.95M $243.3M
Cash From Financing Activities $2.467M 22.00K $2.350M
Net Change In Cash -$35.12M 16.81M -$63.87M
YoY Change -71.47% -108.53% -184.38%
FREE CASH FLOW
Cash From Operating Activities -$95.18M -$66.16M -$309.5M
Capital Expenditures $399.0K $113.0K $4.881M
Free Cash Flow -$95.58M -$66.28M -$314.4M
YoY Change -4.93% -16.73% -23.9%

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Nature of Business<div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">References to Agios</span></div><div style="margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Throughout this Annual Report on Form 10-K, “the Company,” “we,” “us,” and “our,” and similar expressions, except where the context requires otherwise, refer to Agios Pharmaceuticals, Inc. and its consolidated subsidiaries, and “our board of directors” refers to the board of directors of Agios Pharmaceuticals, Inc. </span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Overview</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">We are a biopharmaceutical company committed to transforming patients’ lives through leadership in the field of cellular metabolism, with the goal of creating differentiated, small molecule medicines for rare diseases. With a history of focused study on cellular metabolism, we have a deep and mature understanding of this biology, which is involved in the healthy functioning of nearly every system in the body. We accelerate the impact of our portfolio by cultivating connections with patient communities, healthcare professionals, partners and colleagues to discover, develop and deliver potential therapies for rare diseases. We are located in Cambridge, Massachusetts.</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The lead product candidate in our portfolio, PYRUKYND® (mitapivat), is an activator of both wild-type and mutant pyruvate kinase, or PK, enzymes for the potential treatment of hemolytic anemias. In February 2022, the Food and Drug Administration, or FDA, approved PYRUKYND® for the treatment of hemolytic anemia in adults with PK deficiency in the United States. In November 2022, we received marketing authorization from the European Commission for PYRUKYND® for the treatment of PK deficiency in adult patients in the European Union, or EU. In December 2022, we received marketing authorization in Great Britain for PYRUKYND® for the treatment of PK deficiency in adult patients under the European Commission Decision Reliance Procedure. In addition, we are currently evaluating PYRUKYND® in clinical trials for the treatment of thalassemia, sickle cell disease, or SCD, and in pediatric patients with PK deficiency. We are also developing AG-946, a novel PK activator, for the potential treatment of lower-risk myelodysplastic syndrome, or LR MDS, and hemolytic anemias.</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In addition to the aforementioned clinical development programs, we continue to invest in our late-stage research program focused on advancing a phenylalanine hydroxylase, or PAH, stabilizer for the treatment of phenylketonuria, or PKU.</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">We are subject to risks common to companies in our industry including, but not limited to, uncertainties relating to conducting clinical research and development, the manufacture and supply of products for clinical and commercial use, obtaining and maintaining regulatory approvals and pricing and reimbursement for our products, market acceptance, managing global growth and operating expenses, availability of additional capital, competition, obtaining and enforcing patents, stock price volatility, dependence on collaborative relationships and third-party service providers, dependence on key personnel, potential litigation, product liability claims and government investigations.</span></div><div style="margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Sale of our Oncology Business to Servier</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On March 31, 2021, we completed the sale of our oncology business to Servier Pharmaceuticals, LLC, or Servier, which represented a discontinued operation. The transaction included the sale of our oncology business, including TIBSOVO®, our clinical-stage product candidates vorasidenib, AG-270 and AG-636, and our oncology research programs for a payment of approximately $1.8 billion in cash at the closing, subject to certain adjustments, and a payment of $200.0 million in cash, if, prior to January 1, 2027, vorasidenib is granted new drug application, or NDA, approval from the FDA with an approved label that permits vorasidenib’s use as a single agent for the adjuvant treatment of patients with Grade 2 glioma that have an isocitrate dehydrogenase 1 or 2 mutation (and, to the extent required by such approval, the vorasidenib companion diagnostic test is granted an FDA premarket approval), as well as a royalty of 5% of U.S. net sales of TIBSOVO® from the close of the transaction through loss of exclusivity, and a royalty of 15% of U.S. net sales of vorasidenib from the first commercial sale of vorasidenib through loss of exclusivity. Servier also acquired our co-commercialization rights for Bristol Myers Squibb’s IDHIFA® and the right to receive a $25.0 million potential milestone payment under our prior collaboration agreement with Celgene Corporation, or Celgene, and following the sale Servier will conduct certain clinical development activities within the IDHIFA® development program.</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">We recorded income from royalties of approximately $9.9 million and $6.6 million on U.S. net sales of TIBSOVO® by Servier in the royalty income from gain on sale of oncology business line item within the consolidated statements of operation</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">s</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, for the years ended December 31, 2022 and December 31, 2021, respectively. </span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:112%">Sale of Contingent Payments</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The consideration for the sale of our oncology business to Servier includes a royalty of 5% of U.S. net sales of TIBSOVO® from the close of the transaction through loss of exclusivity, referred to as contingent payments. We recognize the contingent payments in the royalty income from gain on sale of oncology business line item in our consolidated statement of operations in the period when realizable. On October 27, 2022, we sold our rights to future contingent payments to entities affiliated with Sagard Healthcare Partners, or Sagard, and recognized income of $127.9 million within the gain on sale of contingent payments line item in our consolidated statements of operations for the year ended December 31, 2022. We retained our rights to the potential milestone payment and royalties from Servier if vorasidenib is approved by the FDA. </span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:112%">Reclassifications</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Certain amounts in prior periods have been reclassified to reflect the impact of the discontinued operations treatment of the oncology business in order to conform to the current period presentation.</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="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="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On March 31, 2021, we completed the sale of our oncology business to Servier, and received approximately $1.8 billion in cash at closing. In connection with the sale, on March 25, 2021, we announced that our Board of Directors authorized the repurchase of up to $1.2 billion of our outstanding shares of common stock, or the Repurchase Program, using the proceeds from the sale of our oncology business to Servier. On March 31, 2021, in connection with the Repurchase Program, we entered into a definitive share repurchase agreement with Bristol-Myers Squibb Company, or BMS, to repurchase 7.1 million shares of our common stock held by certain subsidiaries of BMS for an aggregate purchase price of $344.5 million, or $48.38 per share. This repurchase was completed on April 5, 2021. Further, on April 2, 2021, in connection with the Repurchase Program, we entered into a Rule 10b5-1 repurchase plan pursuant to which we could repurchase up to $600.0 million of shares of our common stock. On October 5, 2021, we terminated our Rule 10b5-1 share repurchase program and on October 13, 2021 we entered into a Rule 10b-18 repurchase plan that allows us to conduct open market repurchases over time up to our remaining authorization under the Repurchase Program. We have not repurchased any shares of common stock in fiscal year 2022 and as of December 31, 2022 we have repurchased approximately 9.1 million shares of common stock for $458.0 million, or $50.35 per share, under the Rule 10b5-1 repurchase plan. As of December 31, 2022, we have not repurchased any shares under the Rule 10b-18 repurchase plan. In total, as of December 31, 2022, we repurchased 16.2 million shares of common stock for $802.5 million, or $49.49 per share, under the Repurchase Program. We have paused our share repurchases for the foreseeable future.</span></div><div style="margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">On April 30, 2020, we entered into an at-the-market sales agreement, or the 2020 sales agreement, with Cowen &amp; Company LLC, or Cowen, pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $250.0 million through Cowen pursuant to a universal shelf registration statement on Form S-3 filed with the SEC on April 30, 2020. As of December 31, 2022, $250.0 million in common stock remained available for future issuance under the 2020 sales agreement. On February 15, 2023, we delivered written notice to Cowen that we were terminating the 2020 sales agreement, effective on February 22, 2023. As of the termination of the 2020 sales agreement, we had not sold any shares of our common stock under the 2020 sales agreement.</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">As of December 31, 2022, we had cash, cash equivalents and marketable securities of $1.1 billion. Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and marketable securities to be sufficient to fund current operations for at least the next twelve months from the issuance of the financial statements. If we are unable to raise additional funds through equity or debt financings, we may be required to delay, limit, reduce or terminate product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.</span></div>
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<div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of estimates</span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of our consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making </span></div>judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including expenses, reserves and allowances, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and any variant strains of the virus and the actions taken to contain the pandemic or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates.
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<div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Concentrations of credit risk </span></div><div style="margin-bottom:6pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Financial instruments which potentially subject us to credit risk consist primarily of cash, cash equivalents, and marketable securities. We hold these investments in highly rated financial institutions, and, by policy, limit the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. We have not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements.</span></div>
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CY2022 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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CY2022 us-gaap Effective Income Tax Rate Reconciliation At Federal Statutory Income Tax Rate
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CY2022Q4 us-gaap Deferred Tax Assets Tax Deferred Expense Reserves And Accruals Reserves
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CY2022Q4 us-gaap Deferred Tax Assets Gross
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3767000 usd
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CY2022Q4 us-gaap Deferred Tax Assets Valuation Allowance
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CY2022Q4 us-gaap Deferred Tax Assets Liabilities Net
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1970000 usd
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3089000 usd
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24220000 usd
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0 usd
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CY2022 agio Number Of States Federal Or Foreign In Auditing Process
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CY2022 us-gaap Defined Contribution Plan Employer Matching Contribution Percent Of Match
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1
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0.04

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