PUMA BIOTECHNOLOGY, INC. This Annual Report on Form 10-K contains forward-looking statements within the meanings of the federal securities laws. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see the "Risk Factors" section in Item 1A of Part I of this Form 10-K. We caution the reader not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this Form 10-K. We undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Form 10-K.
Overview
We are a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. We in-license from Pfizer the global development and commercialization rights to PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, we are primarily focused on the development and commercialization of the oral version of neratinib, and our most advanced drug candidates are directed at the treatment of HER2-positive breast cancer and HER2 mutated cancers. We believe neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2, such as breast cancer, cervical cancer, lung cancer or other solid tumors.
Prior to 2017, our efforts and resources were focused primarily on acquiring and
developing our pharmaceutical technologies, raising capital and recruiting
personnel. In 2017, the FDA approved NERLYNX, formally known as PB272
(neratinib(oral)), for the extended adjuvant treatment of adult patients with
early stage HER2-overexpressed/amplified breast cancer following
trastuzumab-based therapy. In 2018, the EC granted marketing authorization for
NERLYNX in the
We have entered into exclusive sub-license agreements with various parties to
pursue regulatory approval, if necessary, and commercialize NERLYNX, if
approved, in various specified regions outside of
Our expenses to date have been related to hiring staff, commencing company-sponsored clinical trials and the build out of our corporate infrastructure and, since 2017, the commercial launch of NERLYNX. Accordingly, our success depends not only on the safety and efficacy of our product candidates, but also on our ability to finance product development. To date, our major sources of working capital have been proceeds from product and license revenue, public offerings of our common stock, proceeds from our credit facility and sales of our common stock in private placements.
Impact of COVID-19
Our priorities during the COVID-19 pandemic are protecting the health and safety
of our employees while continuing our mission to develop and commercialize
innovative products to enhance cancer care. Substantially all geographic regions
in which our
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Our ability to continue to operate without any significant negative impacts will
in part depend on the length and severity of the COVID-19 pandemic and our
ability to protect our employees and our supply chain. We continue to follow and
monitor recommended actions of government and health authorities to protect our
employees worldwide. For the year ended
We intend to satisfy our near-term liquidity requirements through a combination
of our existing cash and cash equivalents and marketable securities as of
Summary of Income and Expenses
Product revenue, net
Product revenue, net consists of revenue from sales of NERLYNX. We sell NERLYNX
to a limited number of specialty pharmacies and specialty distributors in
License revenue
License revenue consists of consideration earned for performance obligations satisfied pursuant to our sub-license agreements.
Royalty revenue
Royalty revenue consists of consideration earned related to product sales made by our sub-licensees in their respective territories pursuant to our license agreements.
Cost of sales
Cost of sales consists of third-party manufacturing costs, freight, and indirect overhead costs associated with sales of NERLYNX. Cost of product sales also includes period costs related to royalty charges payable to Pfizer, the amortization of milestone payments under our license agreement with Pfizer, certain inventory manufacturing services, inventory adjustment charges, unabsorbed manufacturing and overhead costs, and manufacturing variances.
Selling, general and administrative expenses
Selling, general and administrative, or SG&A, expenses, consist primarily of salaries and payroll-related costs, stock-based compensation expense, professional fees, business insurance, rent, general legal activities, credit loss expense and other corporate expenses. We expense SG&A expenses as they are incurred.
Research and development expenses
Research and development, or R&D, expenses include costs associated with
services provided by consultants who conduct clinical services on our behalf,
contract organizations for manufacturing of clinical materials and clinical
trials. During the years ended
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Results of Operations
The following summarizes our results of operations for the years ended
Total revenue
Total revenue was approximately
Product revenue, net
Product revenue, net was approximately
License revenue
License revenue was approximately
Royalty revenue
Royalty revenue was approximately
Cost of sales
Cost of sales was approximately
Selling, general and administrative expenses:
Selling, general, and
administrative expenses For the Year Ended Change
(in thousands) December 31, $ %
2020 2019 2020/2019 2020/2019
Payroll and related costs $ 41,313 $ 41,415 $ (102 ) -0.2 %
Professional fees and expenses 42,935 49,060 (6,125 ) -12.5 %
Travel and meetings 4,726 10,987 (6,261 ) -57.0 %
Facilities and equipment costs 5,673 5,803 (130 ) -2.2 %
Loss on impairment of asset - 1,183 (1,183 ) -100.0 %
Stock-based compensation 17,778 27,892 (10,114 ) -36.3 %
Credit loss expense 1,000 - 1,000 100.0 %
Other 5,063 5,299 (236 ) -4.5 %
$ 118,488 $ 141,639 $ (23,151 ) -16.3 %
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Total SG&A expenses decreased approximately 16.3% to
• a decrease in stock-based compensation expense of approximately $10.1
million , primarily due to a decrease of approximately $6.9 million for
stock options and restricted stock units that have fully vested, a decrease
of approximately $5.1 million from stock awards forfeited and a decrease of
approximately $2.7 million from stock award modifications partially offset
by an increase of approximately $4.8 million from new grants and other
immaterial fluctuations;
• a decrease in professional fees of approximately $6.1 million , consisting
primarily of decreases of approximately $6.6 million in legal fees in
connection with various lawsuits and approximately $0.9 million for
professional fees primarily related to decreased consultancy efforts
related to marketing and commercialization support, partially offset by an
increase of approximately $1.0 million in insurance premiums and $0.4
million in audit and board of directors fees;
• a decrease in travel and meeting related costs of approximately $6.3
million related to travel restrictions and cancellations of on-site events
due to the COVID-19 pandemic;
• a loss of approximately $1.2 million for the year ended December 31, 2019
in connection with our decision to sublease the right to use a portion of
our leased office space recorded as an operating asset in accordance with
ASC 842, with no impairment loss in 2020;
• a decrease in other, facilities and equipment costs for $0.4 million ;
• a decrease in payroll and related costs of $0.1 million ;
which were partially offset by:
• a credit loss expense of $1.0 million for the year ended December 31, 2020
for an amount owed from a sub-license partner relating to license revenue
recognized during the third quarter of 2019, compared to no credit loss
expense for the year ended December 31, 2019 .
Research and development expenses:
Research and development expenses For the Year Ended Change
(in thousands) December 31, $ %
2020 2019 2020/2019 2020/2019
Clinical trial expense $ 31,428 $ 51,545 $ (20,117 ) -39.0 %
Internal R&D 38,736 39,603 (867 ) -2.2 %
Consultant and contractors 8,689 12,268 (3,579 ) -29.2 %
Stock-based compensation 18,797 29,435 (10,638 ) -36.1 %
$ 97,650 $ 132,851 $ (35,201 ) -26.5 %
Total R&D expenses decreased approximately 26.5% to
• a decrease in stock-based compensation expense of approximately $10.6
million , primarily due to a decrease of approximately $8.3 million for
stock options and restricted stock units that have fully vested and a
decrease of approximately $4.5 million from stock awards forfeited,
partially offset by an increase of approximately $2.0 million from new
grants and other immaterial fluctuations;
• a decrease in internal R&D expense of approximately $0.9 million , primarily
due to a decrease in payroll and payroll-related expenses as a result of
reduction in headcount;
• a decrease in clinical trial expenses of approximately $20.1 million ,
primarily due to the close out of certain clinical trials and a reduction
in enrollments and patients for open studies; and
• a decrease in consultant and contractors of approximately $3.6 million ,
primarily due to the close out of certain clinical trials.
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Other income and expenses:
Other income (expenses) For the Year Ended Change
(in thousands) December 31, $ %
2020 2019 2020/2019 2020/2019
Interest income $ 489 $ 2,847 $ (2,358 ) -82.8 %
Interest expense (14,046 ) (15,019 ) 973 -6.5 %
Legal verdict expense (16,196 ) (16,350 ) 154 -0.9 %
Loss on debt extinguishment - (8,103 ) 8,103 100.0 %
Other income 367 128 239 186.7 %
$ (29,386 ) $ (36,497 ) $ 7,111 -19.5 %
Interest income
For the year ended
Interest expense
For the year ended
Legal verdict expense
For the year ended
For the year ended
Loss on debt extinguishment
For the year ended
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Non-GAAP Financial Measures:
In addition to our operating results, as calculated in accordance with
Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss and GAAP Net Loss
Per Share to Non-GAAP Adjusted Net Loss Per Share
(in thousands except share and per share data)
For the Year Ended December 31,
2020 2019
GAAP net loss $ (59,995 ) $ (75,595 )
Adjustments:
Stock-based compensation -
Selling, general and administrative 17,778 27,892 (1)
Research and development 18,797 29,435 (2)
Non-GAAP adjusted net loss $ (23,420 ) $ (18,268 )
GAAP net loss per share-basic $ (1.52 ) $ (1.95 )
Adjustment to net loss (as detailed
above) 0.93 1.48
Non-GAAP adjusted basic net loss per
share $ (0.59 ) $ (0.47 ) (3)
(1) To reflect a non-cash charge to operating expense for selling, general, and
administrative stock-based compensation.
(2) To reflect a non-cash charge to operating expense for research and development
stock-based compensation.
(3) Non-GAAP adjusted basic net loss per share was calculated based 39,576,107 and
38,768,653 weighted-average shares of common stock outstanding for the years ended
December 31, 2020 and 2019, respectively.
Liquidity and Capital Resources
The following table summarizes our liquidity and capital resources as of and for
the years ended
As of As of
Liquidity and capital resources (in thousands)
$ 85,293 $ 60,037
Marketable securities $ 8,096 $ 51,607
Working capital $ 31,884 $ 75,459
Stockholders' (deficit) equity $ (5,951 ) $ 17,463
Year Ended Year Ended
December 31, 2020 December 31, 2019
Cash provided by (used in):
Operating activities $ 773 $ 22,376
Investing activities 23,403 5,163
Financing activities 68 (67,067 )
Net increase (decrease) in cash, cash equivalents $ 24,244 $ (39,528 )
and restricted cash
Operating Activities
We recorded net losses of approximately
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Net cash provided by operating activities for the year ended
Net cash used in operating activities for the year ended
Investing Activities
During the year ended
During the year ended
Financing Activities
During the year ended
During the year ended
Loan and Security Agreement
In
On
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promissory notes of
The New Credit Facility is secured by substantially all of our personal property
other than our intellectual property. We also pledged 65% of the issued and
outstanding capital stock of our subsidiaries,
The term loans under the New Credit Facility bear interest at an annual rate
equal to the greater of (i) 9.0% and (ii) the sum of (a) the "prime rate," as
reported in The Wall Street Journal on the last business day of the month that
immediately precedes the month in which the interest will accrue, plus (b) 3.5%.
We are required to make monthly interest-only payments on each term loan under
the New Credit Facility commencing on the first calendar day of the calendar
month following the funding date of such term loan, and continuing on the first
calendar day of each calendar month thereafter through
At our option, we may prepay the outstanding principal balance of any term loan in whole but not in part, subject to a prepayment fee of 3.0% of the amount prepaid if the prepayment occurs through and including the first anniversary of the funding date of such term loan, 2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the funding date of such term loan through and including the second anniversary of the funding date of such term loan, and 1.0% of the amount prepaid if the prepayment occurs after the second anniversary of the funding date of such term loan and prior to the Maturity Date.
The New Credit Facility includes affirmative and negative covenants applicable to us, our current subsidiaries and any subsidiaries we create in the future. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding deposit accounts. We must also achieve certain product revenue targets, measured as of the last day of each fiscal quarter on a trailing year to date basis. New minimum revenue levels will be established for each fiscal year by mutual agreement of us, Oxford, as collateral agent, and the lenders under the New Credit Facility. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions.
The New Credit Facility also includes events of default, the occurrence and
continuation of which could cause interest to be charged at the rate that is
otherwise applicable plus 5.0% and would provide Oxford, as collateral agent,
with the right to exercise remedies against us and the collateral securing the
New Credit Facility, including foreclosure against the property securing the New
Credit Facility, including our cash. These events of default include, among
other things, our failure to pay principal or interest due under the New Credit
Facility, a breach of certain covenants under the New Credit Facility, our
insolvency, a material adverse change, the occurrence of any default under
certain other indebtedness in an amount greater than
On
As of
Current and Future Financing Needs
We did not receive or record any product revenues until the third quarter of 2017. We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials, our R&D efforts and our commercialization efforts.
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We may choose to begin new R&D efforts or we may choose to launch additional
marketing efforts. These efforts may require funding in addition to the cash and
cash equivalents totaling approximately
In addition, we have based our estimate of capital needs on assumptions that may prove to be wrong. Changes may occur that would consume our available capital faster than anticipated, including changes in and progress of our development activities, the impact of commercialization efforts, acquisitions of additional drug candidates and changes in regulation. Potential sources of financing include strategic relationships, public or private sales of equity or debt and other sources of funds. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interests of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations, and our business, financial condition and results of operations would be materially harmed. In such an event, we will be required to undertake a thorough review of our programs, and the opportunities presented by such programs, and allocate our resources in the manner most prudent.
Off-Balance Sheet Arrangements
We do not have any "off-balance sheet arrangements," as defined by the
Contractual Obligations
Contractual obligations represent future cash commitments and liabilities under
agreements with third parties and exclude contingent liabilities for which we
cannot reasonably predict future payment. Our contractual obligations result
from leases for office space and office equipment and the principal and interest
owed under our credit facility. We also have unrecognized tax benefits that, if
recognized, would affect the effective tax rate at
The following table represents our contractual obligations as of
Less More
than 1 - 3 3 - 5 than
Contractual Obligations Total 1 year years years 5 years
Operating lease obligations
-
Debt obligations
(principal and interest) 126,509 23,194 78,214 25,101 - Total$ 156,285 $ 28,559 $ 89,328 $ 38,398 - 71
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Although we do have obligations for CRO services, the table above excludes
potential payments we may be required to make under our agreements with CROs
because timing of payments and actual amounts paid under those agreements may be
different depending on the timing of receipt of goods or services or changes to
agreed-upon terms or amounts for some obligations, and those agreements are
cancelable upon written notice by us and therefore, not long-term liabilities.
The contracts also contain variable costs and milestones that are hard to
predict as they are based on such things as patients enrolled and clinical trial
sites, which can vary and therefore, are also not included in the table above.
The contracts held by us as of
Estimated
Contractual
Obligation
as of Months
December 31, Remaining
Indication 2020 on Contract
HER2 Overexpressed/Amplified Breast Cancer (Extension) $ 5,242 12
HER2 Overexpressed/Amplified Breast Cancer (Licensor Legacy Clinical Trials)
371 3
HER2 Mutated Breast Cancer and HER2 Mutated Breast Cancer with Brain Metastases
456 24
Metastatic & Adjuvant Breast Cancer 10,399 5
Pre-Clinical Research 22,003 14
Post-Clinical Research 1,256 11
HER2 Mutated Solid Tumors 2,645 10
Other 24,849 15
Total $ 67,221 In regard to our contractual obligations in relation to the Pfizer in-license
agreement, as consideration for the license, we are required to make substantial
payments upon the achievement of certain milestones totaling approximately
See Note 13-Income Taxes and Note 14-Commitments and Contingencies in the
accompanying notes to the financial statements for a summary of our uncertain
tax positions and contracts held by us as of
Critical Accounting Policies
The discussion and analysis of our consolidated financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in conformity with GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, and expenses, and related disclosure of contingent assets and liabilities reported in our consolidated financial statements. The estimation process requires assumptions to be made about future events and conditions and, as a result, is inherently subjective and uncertain. Actual results could differ materially from our estimates.
The
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Revenue Recognition
Under Accounting Standards Codification, or ASC, Topic 606 - Revenue from
Contracts with Customers, or ASC 606, we recognize revenue when a customer
obtains control of the promised goods or services, in an amount that reflects
the consideration which we expect to be entitled in exchange for those goods or
services. We had no contracts with customers until the FDA approved NERLYNX on
Product Revenue, Net:
We sell NERLYNX to a limited number of specialty pharmacies and specialty
distributors in
We recognize revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of our product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration.
Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales.
Reserves for Variable Consideration:
Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between us and our customers, payors, and other indirect customers relating to the sale of our products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable or a current liability. These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.
The amount of variable consideration which is included in the transaction price
may be constrained, and is included in the net sales price only to the extent
that it is probable that a significant reversal in the amount of the cumulative
revenue recognized under the contract will not occur in a future period. Our
analyses also contemplated application of the constraint in accordance with the
guidance, under which it determined a significant reversal of revenue would not
occur in a future period for the estimates detailed below as of
Trade Discounts and Allowances:
We generally provide customers with discounts which include incentive fees that are explicitly stated in our contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we compensate (through trade discounts and allowances) our customers for sales order management, data, and distribution services. However, we have determined such services received to date are not distinct from our sale of products to the customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations.
Product Returns:
Consistent with industry practice, we offer the specialty pharmacies and specialty distributors limited product return rights for damaged and expiring products, provided it is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as a reduction to accounts receivables, net on the consolidated balance sheets. We currently estimate product returns using our sales information,
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including our visibility into the inventory remaining in the distribution channel. We have an insignificant amount of returns to date and believe that returns of our products will continue to be minimal.
Provider Chargebacks and Discounts:
Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and a reduction to accounts receivable, net on the consolidated balance sheets. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and we generally issue credits for such amounts within a few weeks of the customer's notification to us of the resale. Chargebacks consist of credits that we expect to issue for units that remain in the distribution channel at each reporting period end that we expect will be sold to qualified healthcare providers, and chargebacks that customers have claimed, but for which we have not yet issued a payment.
Government Rebates:
We are subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheets. Our liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period.
Payor Rebates:
We contract with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. We estimate these rebates and record such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.
Other Incentives:
Other incentives which we offer include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses on the consolidated balance sheets.
License Revenue:
We recognize license revenue under certain of our sub-license agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. We evaluate these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, up-front fees that are not contingent on any future performance and require no consequential continuing involvement by us, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. We defer recognition of non-refundable upfront license fees if the performance obligations are not satisfied.
Prior to recognizing revenue, we make estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration.
If there are multiple distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to
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customers or using expected cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure.
Royalty Revenue:
For sub-license agreements that are within the scope of ASC 606, we recognize revenue when the related sales occur in accordance with the sales-based royalty exception under ASC 606-10-55-65. Royalty revenue consists of consideration earned related to international sales of NERLYNX made by our sub-licensees in their respective territories. We recognize royalty revenue when the performance obligations have been satisfied.
Legal Contingencies and Expense
For legal contingencies, we accrue a liability for an estimated loss if the potential loss from any claim or legal proceeding is considered probable and the amount can be reasonably estimated. Legal fees and expenses are expensed as incurred based on invoices or estimates provided by legal counsel. We periodically evaluate available information, both internal and external, relative to such contingencies and adjust the accrual as necessary. We determine whether a contingency should be disclosed by assessing whether a material loss is deemed reasonably possible. In determining whether a loss should be accrued, we evaluate, among other factors, the degree of probability of an unfavorable outcome and the ability to make a reasonable estimate of the amount of the loss (see Note 14-Commitments and Contingencies in the accompanying notes to the financial statements).
Recently Issued Accounting Standards
In
In
In
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