2024 Q1 Form 10-K Financial Statement

#000143922224000035 Filed on February 15, 2024

View on sec.gov

Income Statement

Concept 2024 Q1 2023 Q4 2023
Revenue $8.189M $7.103M $26.82M
YoY Change 46.0% 64.8% 88.36%
Cost Of Revenue $627.0K $586.0K $2.881M
YoY Change 13.18% 41.89% 69.07%
Gross Profit $7.562M $6.517M $23.94M
YoY Change 49.59% 67.23% 90.99%
Gross Profit Margin 92.34% 91.75% 89.26%
Selling, General & Admin $31.01M $35.31M $119.9M
YoY Change 9.33% 7.73% -1.45%
% of Gross Profit 410.13% 541.74% 500.81%
Research & Development $68.62M $77.49M $295.5M
YoY Change 1.96% 10.23% 5.58%
% of Gross Profit 907.43% 1189.03% 1234.34%
Depreciation & Amortization $1.348M $1.423M $6.600M
YoY Change -24.69% -21.55% -21.43%
% of Gross Profit 17.83% 21.84% 27.57%
Operating Expenses $99.63M $112.8M $415.4M
YoY Change 4.15% 9.44% 3.45%
Operating Profit -$92.07M -$106.3M -$391.5M
YoY Change 1.61% 7.16% 0.63%
Interest Expense $8.889M $8.624M $33.34M
YoY Change 9.86% 32.92% 160.64%
% of Operating Profit
Other Income/Expense, Net $1.634M $1.713M $6.055M
YoY Change 8.64% 26.23% -10.28%
Pretax Income -$81.55M -$95.94M -$352.1M
YoY Change 0.66% -362.66% 51.89%
Income Tax
% Of Pretax Income
Net Earnings -$81.55M -$95.94M -$352.1M
YoY Change 0.66% -362.66% 51.89%
Net Earnings / Revenue -995.84% -1350.7% -1312.63%
Basic Earnings Per Share -$1.45 -$6.33
Diluted Earnings Per Share -$1.45 -$1.72 -$6.33
COMMON SHARES
Basic Shares Outstanding 56.19M shares 55.89M shares 55.65M shares
Diluted Shares Outstanding 56.38M shares 55.65M shares

Balance Sheet

Concept 2024 Q1 2023 Q4 2023
SHORT-TERM ASSETS
Cash & Short-Term Investments $598.0M $776.9M $776.9M
YoY Change -19.1% -0.79% -0.79%
Cash & Equivalents $118.8M $88.21M $88.21M
Short-Term Investments $479.2M $688.7M $688.7M
Other Short-Term Assets $39.11M $35.02M $35.02M
YoY Change -0.48% -10.1% -10.1%
Inventory $23.07M $19.08M $19.08M
Prepaid Expenses
Receivables $3.453M $2.810M $2.810M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $663.6M $833.8M $833.8M
YoY Change -16.17% 0.13% 0.13%
LONG-TERM ASSETS
Property, Plant & Equipment $65.72M $15.38M $69.79M
YoY Change 206.58% -33.08% -20.8%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $116.3M $29.44M $29.44M
YoY Change -57.2% -90.62% -90.62%
Other Assets $4.056M $4.057M $4.057M
YoY Change 2.53% 2.55% 2.55%
Total Long-Term Assets $186.1M $103.3M $103.3M
YoY Change -48.26% -74.56% -74.56%
TOTAL ASSETS
Total Short-Term Assets $663.6M $833.8M $833.8M
Total Long-Term Assets $186.1M $103.3M $103.3M
Total Assets $849.7M $937.1M $937.1M
YoY Change -26.2% -24.35% -24.35%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $11.16M $9.780M $9.780M
YoY Change 28.78% -47.46% -47.46%
Accrued Expenses $40.54M $43.17M $58.18M
YoY Change 80.49% 42.23% 32.18%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $51.69M $67.96M $67.96M
YoY Change 14.58% 8.5% 8.5%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $54.10M $1.156M $58.14M
YoY Change 4020.03% -64.75% -22.76%
Total Long-Term Liabilities $54.10M $1.156M $58.14M
YoY Change 4020.03% -64.75% -22.76%
TOTAL LIABILITIES
Total Short-Term Liabilities $51.69M $67.96M $67.96M
Total Long-Term Liabilities $54.10M $1.156M $58.14M
Total Liabilities $105.8M $126.1M $126.1M
YoY Change -7.83% -8.56% -8.56%
SHAREHOLDERS EQUITY
Retained Earnings -$904.2M -$822.6M
YoY Change 63.93% 74.82%
Common Stock $2.452B $2.437B
YoY Change 2.2% 2.1%
Preferred Stock
YoY Change
Treasury Stock (at cost) $802.5M $802.5M
YoY Change 0.0% 0.0%
Treasury Stock Shares
Shareholders Equity $743.9M $811.0M $811.0M
YoY Change
Total Liabilities & Shareholders Equity $849.7M $937.1M $937.1M
YoY Change -26.2% -24.35% -24.35%

Cashflow Statement

Concept 2024 Q1 2023 Q4 2023
OPERATING ACTIVITIES
Net Income -$81.55M -$95.94M -$352.1M
YoY Change 0.66% -362.66% 51.89%
Depreciation, Depletion And Amortization $1.348M $1.423M $6.600M
YoY Change -24.69% -21.55% -21.43%
Cash From Operating Activities -$99.87M -$72.46M -$296.1M
YoY Change 4.92% 9.52% -4.34%
INVESTING ACTIVITIES
Capital Expenditures $141.0K $199.0K $999.0K
YoY Change -64.66% 76.11% -79.53%
Acquisitions
YoY Change
Other Investing Activities $124.7M $95.77M $240.6M
YoY Change 115.02% 15.3% -3.05%
Cash From Investing Activities $124.6M $95.48M $239.6M
YoY Change 116.27% 15.1% -1.52%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 5.864M 833.0K $5.433M
YoY Change 137.7% 3686.36% 131.19%
NET CHANGE
Cash From Operating Activities -99.87M -72.46M -$296.1M
Cash From Investing Activities 124.6M 95.48M $239.6M
Cash From Financing Activities 5.864M 833.0K $5.433M
Net Change In Cash 30.56M 23.85M -$51.05M
YoY Change -187.01% 41.86% -20.06%
FREE CASH FLOW
Cash From Operating Activities -$99.87M -$72.46M -$296.1M
Capital Expenditures $141.0K $199.0K $999.0K
Free Cash Flow -$100.0M -$72.66M -$297.1M
YoY Change 4.63% 9.63% -5.5%

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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,” “Agios,” “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 medicines for rare diseases, with a focus on classical hematology. 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. Building on this expertise, these learnings can be rapidly applied to our clinical trials with the goal of developing medicines that can have a significant impact for patients. 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="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 U.S. 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 (i) AG-946, a novel PK activator, for the potential treatment of lower-risk myelodysplastic syndrome, or LR MDS, and hemolytic anemias, and (ii) AG-181, our phenylalanine hydroxylase, or PAH, stabilizer for the potential treatment of phenylketonuria, or PKU.</span></div><div><span><br/></span></div><div style="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 development programs, in July 2023 we entered into a license agreement with Alnylam Pharmaceuticals, Inc., or Alnylam for the development and commercialization of products containing or comprised of an siRNA preclinical development candidate discovered by Alnylam and targeting the transmembrane serine protease 6, or TMPRSS6, gene and we intend to pursue development of a licensed product for the potential disease-modifying treatment of patients with polycythemia vera, or PV, a rare blood disorder. </span></div><div><span><br/></span></div><div style="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 preclinical and 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, potential product liability claims and potential government investigations. </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%">Alnylam License 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%">On July 28, 2023, we entered into a license agreement with Alnylam under which we acquired the rights to develop and commercialize Alnylam’s novel preclinical siRNA targeting the TMPRSS6 gene, as a potential disease-modifying treatment for patients with PV. Because the acquired assets do not meet the definition of a business in accordance with ASC 805, Business Combinations, we will account for the agreement as an asset acquisition. </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%">In accordance with the license agreement, in the twelve months ended December 31, 2023, we made an up-front payment to Alnylam and recognized in-process research and development of $17.5 million which was recorded in research and development expense within our Consolidated Statements of Operations and classified as investing activities within our Consolidated Statements of Cash Flows. We will also pay Alnylam for certain expenses associated with the development of TMPRSS6 and these will be recorded in our Consolidated Statements of Operations as incurred. Additionally, we are responsible to pay up to $130.0 million in potential development and regulatory milestones, in addition to sales milestones as well as tiered royalties on annual net sales, if any, of licensed products, which may be subject to specified reductions and offsets.</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 Oncology Business to Servier and 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%">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%">In October 2022, we sold our rights to future contingent payments associated with the royalty of 5% of U.S. net sales of TIBSOVO® from the close of the transaction through the loss of exclusivity 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 retain our rights to the potential milestone payment and royalties from Servier if a new drug application for 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-weight:400;line-height:120%">We recorded income from royalties of $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%">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:115%">As of December 31, 2023, we had cash, cash equivalents and marketable securities of $806.4 million. 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><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: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>
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CY2023 us-gaap Use Of 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%">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 judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. The full extent to </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%">which the recent COVID-19 pandemic, or other pandemics or public health emergencies, may in the future 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.</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%">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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CY2023Q4 agio Contract With Customer Total Allowances And Reserves
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CY2022Q4 agio Contract With Customer Contractual Adjustment Reserve
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CY2023Q4 agio Contract With Customer Allowance And Reserves Liability
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