2020 Q4 Form 10-K Financial Statement

#000143922221000029 Filed on February 25, 2021

View on sec.gov

Income Statement

Concept 2020 Q4 2020 Q3 2020 Q2
Revenue $44.05M $34.71M $37.35M
YoY Change 24.28% 33.36% 42.43%
Cost Of Revenue $960.0K $638.0K $675.0K
YoY Change 231.03% 62.34% 122.77%
Gross Profit $43.09M $34.07M $36.67M
YoY Change 22.59% 32.92% 41.49%
Gross Profit Margin 97.83% 98.16% 98.19%
Selling, General & Admin $39.78M $34.84M $35.95M
YoY Change 14.21% 5.51% 10.99%
% of Gross Profit 92.32% 102.27% 98.03%
Research & Development $95.74M $51.94M $54.09M
YoY Change -9.89% -48.91% -49.64%
% of Gross Profit 222.19% 152.47% 147.49%
Depreciation & Amortization $2.700M $2.400M $2.400M
YoY Change 35.0% 14.29% 20.0%
% of Gross Profit 6.27% 7.04% 6.54%
Operating Expenses $135.5M $51.94M $54.09M
YoY Change -3.94% -61.55% -61.39%
Operating Profit -$92.43M -$80.29M -$83.26M
YoY Change -12.74% -26.38% -26.87%
Interest Expense $790.0K $1.120M $1.770M
YoY Change -77.93% -61.25% -55.64%
% of Operating Profit
Other Income/Expense, Net -$6.010M $0.00 $0.00
YoY Change
Pretax Income -$84.54M -$79.18M -$81.50M
YoY Change -17.4% -25.43% -25.83%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$97.66M -$98.98M -$90.48M
YoY Change -4.58% -6.78% -17.65%
Net Earnings / Revenue -221.73% -285.19% -242.26%
Basic Earnings Per Share -$1.41 -$1.43 -$1.31
Diluted Earnings Per Share -$1.41 -$1.43 -$1.31
COMMON SHARES
Basic Shares Outstanding 69.26M shares 69.14M shares 68.96M shares
Diluted Shares Outstanding 69.14M shares 68.96M shares

Balance Sheet

Concept 2020 Q4 2020 Q3 2020 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $572.9M $605.5M $790.1M
YoY Change 1.43% 34.0% 59.49%
Cash & Equivalents $127.4M $104.9M $295.9M
Short-Term Investments $445.5M $500.7M $494.3M
Other Short-Term Assets $23.70M $28.90M $27.00M
YoY Change -2.07% 44.5% 41.36%
Inventory $14.70M $11.37M $11.23M
Prepaid Expenses
Receivables $21.30M $19.00M $13.70M
Other Receivables $0.00 $4.300M $4.300M
Total Short-Term Assets $636.7M $669.1M $846.4M
YoY Change 4.08% 36.51% 58.58%
LONG-TERM ASSETS
Property, Plant & Equipment $30.82M $33.50M $33.93M
YoY Change -2.09% 39.21% 47.4%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $97.60M $116.9M $4.300M
YoY Change -36.17% 31.94% -96.66%
Other Assets $0.00 $1.350M $1.575M
YoY Change
Total Long-Term Assets $216.3M $239.4M $129.8M
YoY Change -22.49% 14.82% -48.12%
TOTAL ASSETS
Total Short-Term Assets $636.7M $669.1M $846.4M
Total Long-Term Assets $216.3M $239.4M $129.8M
Total Assets $853.0M $908.4M $976.1M
YoY Change -4.24% 30.04% 24.53%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $17.72M $12.85M $15.46M
YoY Change -19.05% -40.25% 0.17%
Accrued Expenses $30.80M $49.72M $41.91M
YoY Change -42.04% 6.36% -14.85%
Deferred Revenue $0.00 $0.00 $0.00
YoY Change -100.0% -100.0% -100.0%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $300.0K $300.0K $300.0K
YoY Change 0.0%
Total Short-Term Liabilities $94.39M $69.77M $64.35M
YoY Change 1.62% -24.52% -28.1%
LONG-TERM LIABILITIES
Long-Term Debt $300.0K $400.0K $500.0K
YoY Change -57.14%
Other Long-Term Liabilities $358.7M $357.8M $352.8M
YoY Change 128.91% 126.6% 118.18%
Total Long-Term Liabilities $359.0M $358.2M $353.3M
YoY Change 128.08% 126.85% 118.49%
TOTAL LIABILITIES
Total Short-Term Liabilities $94.39M $69.77M $64.35M
Total Long-Term Liabilities $359.0M $358.2M $353.3M
Total Liabilities $453.5M $428.0M $417.7M
YoY Change 81.23% 70.98% 66.28%
SHAREHOLDERS EQUITY
Retained Earnings -$1.843B -$1.746B -$1.647B
YoY Change 21.59% 23.49% 25.95%
Common Stock $2.243B $2.226B $2.204B
YoY Change 4.01% 19.55% 19.78%
Preferred Stock
YoY Change
Treasury Stock (at cost) $0.00
YoY Change
Treasury Stock Shares 0.000 shares
Shareholders Equity $399.5M $480.5M $558.5M
YoY Change
Total Liabilities & Shareholders Equity $853.0M $908.4M $976.1M
YoY Change -4.24% 30.04% 24.53%

Cashflow Statement

Concept 2020 Q4 2020 Q3 2020 Q2
OPERATING ACTIVITIES
Net Income -$97.66M -$98.98M -$90.48M
YoY Change -4.58% -6.78% -17.65%
Depreciation, Depletion And Amortization $2.700M $2.400M $2.400M
YoY Change 35.0% 14.29% 20.0%
Cash From Operating Activities -$49.40M -$68.20M -$67.80M
YoY Change -47.22% -20.33% -23.04%
INVESTING ACTIVITIES
Capital Expenditures -$1.000M -$5.200M -$4.200M
YoY Change -85.51% 160.0% 223.08%
Acquisitions
YoY Change
Other Investing Activities $72.50M -$121.1M $26.70M
YoY Change -140.73% -246.79% -59.36%
Cash From Investing Activities $71.30M -$126.2M $22.50M
YoY Change -138.58% -256.97% -65.06%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 600.0K 3.400M 252.1M
YoY Change -99.78% 3.03% 6534.21%
NET CHANGE
Cash From Operating Activities -49.40M -68.20M -67.80M
Cash From Investing Activities 71.30M -126.2M 22.50M
Cash From Financing Activities 600.0K 3.400M 252.1M
Net Change In Cash 22.50M -191.0M 206.8M
YoY Change -2912.5% 9952.63% -1139.2%
FREE CASH FLOW
Cash From Operating Activities -$49.40M -$68.20M -$67.80M
Capital Expenditures -$1.000M -$5.200M -$4.200M
Free Cash Flow -$48.40M -$63.00M -$63.60M
YoY Change -44.18% -24.64% -26.73%

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CY2020 us-gaap Nature Of Operations
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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 scientific leadership in the field of cellular metabolism and adjacent areas of biology, with the goal of creating differentiated, small molecule medicines in the areas of genetically defined diseases, or GDDs, and, until the completion of the sale of our oncology business to Servier as described below, hematologic malignancies and solid tumors. To address our focus areas, we take a systems biology approach to deeply understand disease states, drive the discovery and validation of novel therapeutic targets, and define patient selection strategies, thereby increasing the probability that our experimental medicines will have the desired therapeutic effect. 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%">Our wholly-owned product, TIBSOVO® (ivosidenib) is an oral targeted inhibitor of the mutated isocitrate dehydrogenase 1, or IDH1 enzyme. TIBSOVO® is the first and only U.S. Food and Drug Administration, or FDA-approved therapy for the treatment of adult patients with (i) relapsed or refractory acute myeloid leukemia, or R/R AML, with a susceptible IDH1 mutation as detected by an FDA-approved test (approved by the FDA in July 2018) and (ii) newly diagnosed AML with a susceptible IDH1 mutation as detected by an FDA-approved test who are at least 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy (approved by the FDA in May 2019). In December 2018, we submitted a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, for TIBSOVO® for the treatment of adult patients with R/R AML with an IDH1 mutation. In October 2020, we announced the withdrawal of the MAA based on feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) that the available clinical data from our single arm, uncontrolled Phase 1 trial did not sufficiently support a positive benefit-risk balance for the proposed indication. </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%">Our other marketed product is IDHIFA® (enasidenib), an oral targeted inhibitor of the mutated isocitrate dehydrogenase 2, or IDH2 enzyme and the first and only FDA-approved therapy for patients with R/R AML and an IDH2 mutation. In August 2017, the FDA granted our collaboration partner Celgene approval of IDHIFA® for the treatment of adult patients with R/R AML and an IDH2, mutation as detected by an FDA-approved test. We were eligible to receive royalties at tiered low-double digit to mid-teen percentage rates on any net sales of IDHIFA® and have exercised our rights to provide up to one-third of the field-based commercialization efforts in the United States. In June 2018, Celgene submitted an MAA to the EMA for IDHIFA® for IDH2 mutant-positive AML which it subsequently withdrew in December 2019. On June 11, 2020 we sold our tiered, sales-based royalty rights on worldwide net sales of IDHIFA®, as well as our rights to receive up to $55.0 million in outstanding regulatory milestone payments from Bristol Myers Squibb, or BMS, to Royalty Pharma, or RPI, for $255.0 million.</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%">Our pre-commercial clinical cancer product candidates are vorasidenib and AG-270.</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%">Vorasidenib is an orally available, selective brain-penetrant pan-IDH mutant inhibitor. We are developing vorasidenib for the treatment of IDH mutant-positive low grade glioma and are currently evaluating vorasidenib in clinical trials. </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%">AG-270 is an orally available selective potent inhibitor of methionine adenosyltransferase 2a, or MAT2A. We are currently evaluating AG-270 in a phase 1 dose-escalation and expansion trial in multiple tumor types carrying a methylthioadenosine phosphorylase, or MTAP, deletion.</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%">AG-636 is an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase, or DHODH. In the first quarter of 2020, we made the decision to halt internal development of AG-636, due to limited enrollment in this trial, and will continue to wind down the trial during 2021.We are currently evaluating AG-636 in the phase 1 dose-escalation trial in lymphoma.</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 GDD portfolio, mitapivat, is an activator of both wild-type and mutant pyruvate kinase-R for the potential treatment of hemolytic anemias. We are currently evaluating mitapivat for the treatment of pyruvate kinase, or PK, deficiency, thalassemia and sickle cell disease, or SCD, in clinical trials. We are also developing AG-946, a next-generation PKR activator, for the potential treatment of hemolytic anemias and other indications.</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 development programs, we are seeking to advance a number of early-stage discovery programs in our focus areas of GDDs, malignant hematology and solid tumors based on our scientific leadership in the field of cellular metabolism and adjacent areas of biology.</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-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 June 11, 2020, we sold our tiered, sales-based royalty rights on worldwide net sales of IDHIFA® (enasidenib), as well as our rights to receive up to $55.0 million in outstanding regulatory milestone payments from BMS, to RPI for $255.0 million. Under the 2010 Agreement, we remain eligible to receive a $25.0 million potential milestone payment for the enasidenib program. The potential payment is a $25.0 million milestone payment upon achievement of a specified ex-U.S. commercial milestone event, as well as reimbursement for costs incurred for our co-commercialization efforts and development activities.</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%">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, 2020, $250.0 million in common stock remained available for future issuance 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%">In November 2019, we completed a public offering of 8,250,000 shares of common at an offering price of $31.00 per share. We received net proceeds from this offering of $241.0 million, after deducting underwriting discounts and commissions paid by us. In addition, we granted the underwriters the right to purchase up to an additional 1,237,500 shares of common stock, which was exercised in November 2019, resulting in additional net proceeds to us of $36.2 million, after underwriting discounts and commissions. After giving effect to the full exercise of the over-allotment option, the number of shares sold by us in the public offering totaled 9,487,500 shares, and net proceeds to us totaled $277.2 million, after underwriting discounts and commissions. </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, 2020, we had cash, cash equivalents and marketable securities of $670.5 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 the Company is unable to raise additional funds through equity or debt financings, the Company 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 the Company would otherwise prefer to develop and market itself.</span></div>
CY2019Q4 us-gaap Stock Issued During Period Shares New Issues
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9487500 shares
CY2019Q4 us-gaap Proceeds From Issuance Of Common Stock
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277200000 USD
CY2020Q4 us-gaap Cash Cash Equivalents And Short Term Investments
CashCashEquivalentsAndShortTermInvestments
670500000 USD
CY2020 us-gaap Use Of Estimates
UseOfEstimates
<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 financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. 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 which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including sales, 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 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.</span></div>
CY2020 agio Available For Sale Securities Non Current Minimum Liquidating Period
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CY2020 us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<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><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 also subject to credit risk on our receivables, including trade receivables from our customers and collaboration and royalty receivables from Celgene and CStone Pharmaceuticals, or CStone. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the number of customers using our products. Our trade receivables arise from product sales and have standard payment terms that generally require payment within 30 to 60 days. We have evaluated the creditworthiness of our customers, including Celgene, and determined them to be creditworthy. To date we have not experienced any losses with respect to our receivables.</span></div>
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