Full Press Release Details
Precigen Reports Fourth Quarter and Full Year 2020 Financial Results
Company successfully accomplished anticipated 2020 clinical milestones despite challenges due to the ongoing pandemic
Strengthened balance sheet with successful public offering while streamlining operations and reducing operating costs
Initial data readouts from PRGN-3005 and PRGN-3006 UltraCAR-T
clinical trials demonstrated encouraging expansion, persistence and clinical activity
A PRGN-3006 UltraCAR-T patient
achieved complete remission with incomplete hematologic recovery (CRi) per ELN criteria
Initiated first AdenoVerse immunotherapy clinical trial for PRGN-2009 in HPV-associated solid tumors
Interim data for AG019 ActoBiotics in T1D indicate encouraging trends in C-peptide levels and ability to induce antigen-specific immune modulation following only one treatment cycle of oral AG019 as monotherapy or combination
GERMANTOWN, MD, March 1, 2021 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the
development of innovative gene and cell therapies to improve the lives of patients, today announced fourth quarter and full year 2020 financial results.
2021 promises to be another transformative year for our company with important data readouts and trial initiations anticipated for our key
programs, said Helen Sabzevari, PhD, President and CEO of Precigen. Through a combination of fiscal discipline and our recent capital raise, we have sufficient cash on hand to support our capital needs into 2023. We will continue to work
diligently to advance our pipeline of innovative therapies and technology platforms as quickly as possible and our entire team remains committed to achieving this goal on behalf of the patients that motivate us every day. We look forward to
providing updates in the coming months.
Business Highlights:
Healthcare Transition
January 2020, Precigen announced the change of the parent company s name to Precigen, Inc. from Intrexon Corporation to reflect the Company s tighter healthcare focus. The Company is now trading on Nasdaq under the stock symbol PGEN.
January 2021, Precigen closed a public offering of 17,250,000 shares of common stock, which resulted in gross proceeds to Precigen of approximately $129.4 million before deducting the underwriting discount and other offering expenses payable by
PRGN-3005 UltraCAR-T
PRGN-3005 UltraCAR-T is a first-in-class investigational
therapy under evaluation in an ongoing Phase 1/1b clinical study for the treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer. Study subjects receive the PRGN-3005 infusion either via
intraperitoneal (IP) (Arm A) or intravenous (IV) (Arm B) infusion (clinical trial identifier: NCT03907527). The study is being conducted in collaboration with the University of Washington and Fred Hutchinson Cancer Research Center.
PRGN-3006 UltraCAR-T is a
first-in-class investigational therapy currently under clinical evaluation in an ongoing Phase 1/1b trial for the treatment of patients with relapsed or refractory (r/r)
acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS). Study subjects receive the PRGN-3006 infusion either without prior lymphodepletion (Cohort 1) or following lymphodepleting chemotherapy (Cohort 2) (clinical trial
identifier: NCT03927261). The study is being conducted in collaboration with H. Lee Moffitt Cancer Center & Research Institute.
In 2020, Precigen announced its proprietary electroporation device, UltraPorator, designed to be a viable
scale-up and commercialization solution for decentralized UltraCAR-T manufacturing. UltraPorator is a semi-closed, high-throughput system with a proprietary hardware and software solution and potentially
represents a major advancement over current electroporation devices by significantly reducing the processing time and contamination risk.
AG019 ActoBiotics is a novel investigational therapy designed to address the underlying cause of Type 1 diabetes (T1D) and is currently under
clinical evaluation in an ongoing Phase 1b/2a clinical study for the treatment of early-onset T1D (clinical trial identifier: NCT03751007; EudraCT 2017-002871-24).
PRGN-2009 AdenoVerse Immunotherapy
PRGN-2009 is a first-in-class,
off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform currently under clinical evaluation in an ongoing Phase 1/2 clinical study designed
to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597). The study is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer
PRGN-2012 AdenoVerse Immunotherapy
PRGN-2012 is a first-in-class, investigational OTS AdenoVerse
immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for treatment of recurrent respiratory papillomatosis (RRP).
multigenic investigational therapy for heart failure that uses a non-viral plasmid designed to constitutively express human SDF-1 , VEGF165, and S100A1 gene
products to target the underlying molecular mechanisms of pathological myocardial remodelling. INXN-4001 is delivered to the ventricle via retrograde coronary sinus infusion (RCSI).
Fourth Quarter 2020 Financial Highlights:
Full Year 2020 Financial Highlights:
Fourth Quarter 2020 Financial Results Compared to Prior Year
Total revenues increased $2.3 million, or 14%, over the quarter ended December 31, 2019. Service revenues increased $2.2 million
due to increased customer demand at Trans Ova and Exemplar as well as the expansion of Trans Ova s commercial dairy business. Gross margin on services improved as a result of operational efficiencies gained through reductions in workforce
earlier in the year and a reduction in third-party royalty rate obligations for certain licensed technologies.
Research and development expenses
decreased $2.8 million, or 21% from the quarter ended December 31, 2019. Salaries, benefits, and other personnel costs decreased $1.8 million due to reductions in headcount at Precigen and its ActoBio subsidiary as Precigen
deprioritized certain internal programs at its ActoBio subsidiary in 2019. Selling, general, and administrative ( SG&A ) expenses increased $3.4 million, or 13%, and include a noncash $11.4 million loss on the settlement
agreement with Harvest Intrexon Enterprise Funds in the current year as well as increased noncash share-based compensation expenses attributable to equity grants made in the first quarter of 2020. These increased costs were partially offset by
decreases in fees payable to certain third-party vendors and a reduction in salaries, benefits, and other personnel costs following a 31% reduction in corporate headcount between the fourth quarter of 2019 and the fourth quarter of 2020 to support a
more streamlined organization. There were also reductions in other corporate expenses as part of the streamlined organization and include the impact of the COVID-19 pandemic on travel.
Full Year 2020 Financial Results Compared to Prior Year Period
Total revenues increased $12.5 million, or 14%, over the year ended December 31, 2019 primarily due to an increase in collaboration and licensing
revenues as the Company accelerated the recognition of previously deferred revenue upon the mutual termination of two of its collaboration agreements in 2020. Product and service revenues generated by Trans Ova and Exemplar increased
$5.7 million due to an increase in services performed for new and existing customers and the expansion of Trans Ova s commercial dairy business. Gross margin on products and services improved as a result of operational efficiencies gained
through reductions in workforce, improved inventory management, a reduction in third-party royalty rate obligations for certain licensed technologies, and a decrease in the cost of cows used in production.
Research and development expenses decreased $25.0 million, or 38%, from the year ended December 31, 2019. Salaries, benefits, and other personnel
costs decreased $7.3 million and contract research organization costs and lab supplies decreased $13.9 million as Precigen deprioritized certain internal programs at its ActoBio subsidiary and closed two of its operating divisions in 2019.
SG&A expenses decreased $6.9 million, or 7%, and include a net decrease in fees payable to certain third-party vendors and a reduction of 36% in corporate headcount to support a more streamlined organization. Other corporate expenses
decreased $2.6 million as part of the streamlined organization and include the impact of the COVID-19 pandemic on travel. These decreases were partially offset by increased share-based compensation
expense attributable to equity grants made in in the first quarter of 2020, one-time severance costs for terminated employees, and increased legal fees associated with litigation matters.
Conference Call and Webcast
Precigen will host a conference call today Monday, March 1st at 4:30 PM ET to discuss the financial results and provide a general business update. The
conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada) or 1-412-317-6061
(International) and providing the number 9387943 to join the Precigen Conference Call. Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to
the call. Participants may access the live webcast through Precigen s website in the Events & Presentations section at investors.precigen.com/events-presentations.
Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using
precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable
biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical
Precigen, UltraPorator, UltraCAR-T,
ActoBiotics, AdenoVerse and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.
Cautionary Statement Regarding Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based
upon Precigen s current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of Precigen s business, including the timing, pace and progress of
preclinical studies, clinical trials, discovery programs and related milestones, and the promise of the Company s portfolio of therapies, and in particular its CAR-T therapies. Although management
believes that the plans, objectives and results reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, and actual future results may be materially different from
the plans, objectives and expectations expressed. These risks and uncertainties include, but are not limited to, (i) the impact of the COVID-19 pandemic on our clinical trials, businesses, operating
results, cash flows and/or financial condition, (ii) Precigen s strategy and overall approach to its health-focused business model; (iii) the ability to successfully enter new markets or develop additional products, including the
expected timing and results of investigational studies and preclinical and clinical trials, including any delays or potential delays as a result of the COVID-19 pandemic, whether with its collaborators or
independently; (iv) the ability to successfully enter into optimal strategic relationships with its subsidiaries and operating companies that it may form in the future; (v) the ability to hold or generate significant operating capital,
including through partnering, asset sales and operating cost reductions; (vi) actual or anticipated variations in operating results; (vii) actual or anticipated fluctuations in competitors or collaborators operating results or
changes in their respective growth rates; (viii) cash position; (ix) market conditions in Precigen s industry; (x) the volatility of Precigen s stock price; (xi) the ability, and the ability of
collaborators, to protect Precigen s intellectual property and other proprietary rights and technologies; (xii) the ability, and the ability of collaborators, to adapt to changes in laws or regulations and policies, including
federal, state, and local government responses to the COVID-19 pandemic; (xiii) outcomes of pending and future litigation; (xiv) the rate and degree of market acceptance of any products developed
by Precigen, its subsidiaries, collaborations or joint ventures; (xv) the ability to retain and recruit key personnel; (xvi) expectations related to the use of proceeds from public offerings and other financing efforts; and
(xvii) estimates regarding expenses, future revenue, capital requirements and needs for additional financing. For further information on potential risks and uncertainties, and other important factors, any of which could
cause Precigen s actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Precigen s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.
| Investor Contact: | Media Contact: | |
| Steven Harasym | Glenn Silver | |
| Vice President, Investor Relations | Lazar-FINN Partners | |
| Tel: +1 (301) 556-9850 | glenn.silver@finnpartners.com | |
| investors@precigen.com |
Precigen, Inc. and Subsidiaries
Consolidated Balance Sheets
| (Amounts in thousands) | December 31, 2020 | December 31, 2019 | ||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 51,792 | $ | 65,793 | ||||
| Short-term investments | 48,325 | 9,260 | ||||||
| Receivables | ||||||||
| Trade, net | 16,487 | 20,650 | ||||||
| Related parties, net | 19 | 600 | ||||||
| Notes | 3,689 | 2,942 | ||||||
| Other | 232 | 2,030 | ||||||
| Inventory | 11,359 | 16,097 | ||||||
| Prepaid expenses and other | 7,192 | 5,827 | ||||||
| Current assets held for sale or abandonment | 9,853 | 111,444 | ||||||
| Total current assets | 148,948 | 234,643 | ||||||
| Property, plant and equipment, net | 34,924 | 43,952 | ||||||
| Intangible assets, net | 65,396 | 68,346 | ||||||
| Goodwill | 54,363 | 54,119 | ||||||
| Investments in affiliates | 1,461 | |||||||
| Right-of-use assets | 9,353 | 11,803 | ||||||
| Other assets | 1,603 | 1,349 | ||||||
| Noncurrent assets held for sale or abandonment | 40,090 | |||||||
| Total assets | $ | 314,587 | $ | 455,763 | ||||
| Liabilities and Shareholders Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,598 | $ | 5,528 | ||||
| Accrued compensation and benefits | 8,097 | 13,198 | ||||||
| Other accrued liabilities | 9,549 | 11,674 | ||||||
| Deferred revenue | 2,800 | 5,697 | ||||||
| Lines of credit | 1,922 | |||||||
| Current portion of long-term debt | 360 | 31,670 | ||||||
| Current portion of lease liabilities | 2,657 | 2,634 | ||||||
| Related party payables | 19 | 51 | ||||||
| Current liabilities held for sale or abandonment | 14,047 | 50,538 | ||||||
| Total current liabilities | 42,127 | 122,912 | ||||||
| Long-term debt, net of current portion | 171,522 | 186,321 | ||||||
| Deferred revenue, net of current portion | 23,023 | 48,136 | ||||||
| Lease liabilities, net of current portion | 7,744 | 10,119 | ||||||
| Deferred tax liabilities | 2,897 | 2,834 | ||||||
| Other long-term liabilities | 100 | |||||||
| Long-term liabilities held for sale or abandonment | 13,730 | |||||||
| Total liabilities | 247,413 | 384,052 | ||||||
| Commitments and contingencies | ||||||||
| Shareholders equity | ||||||||
| Common stock | ||||||||
| Additional paid-in capital | 1,886,567 | 1,752,048 | ||||||
| Accumulated deficit | (1,823,390 | ) | (1,652,869 | ) | ||||
| Accumulated other comprehensive income (loss) | 3,997 | (27,468 | ) | |||||
| Total shareholders equity | 67,174 | 71,711 | ||||||
| Total liabilities and shareholders equity | $ | 314,587 | $ | 455,763 |
Precigen, Inc. and Subsidiaries
Consolidated Statements of Operations
| (Amounts in thousands, except share and per share data) | 2020 | Three months ended December 31, 2019 | 2020 | Year ended December 31, 2019 | ||||||||||||
| Revenues | ||||||||||||||||
| Collaboration and licensing revenues | $ | 949 | $ | (658 | ) | $ | 21,208 | $ | 14,059 | |||||||
| Product revenues | 3,952 | 5,297 | 24,349 | 23,780 | ||||||||||||
| Service revenues | 14,284 | 12,096 | 56,899 | 51,803 | ||||||||||||
| Other revenues | 148 | 267 | 722 | 1,080 | ||||||||||||
| Total revenues | 19,333 | 17,002 | 103,178 | 90,722 | ||||||||||||
| Operating Expenses | ||||||||||||||||
| Cost of products | 7,024 | 7,800 | 28,550 | 31,930 | ||||||||||||
| Cost of services | 6,766 | 7,611 | 26,963 | 29,471 | ||||||||||||
| Research and development | 10,671 | 13,485 | 41,644 | 66,666 | ||||||||||||
| Selling, general and administrative | 30,039 | 26,646 | 91,704 | 98,634 | ||||||||||||
| Impairment of goodwill | 29,642 | 29,820 | ||||||||||||||
| Impairment of other noncurrent assets | 542 | 920 | 990 | |||||||||||||
| Total operating expenses | 54,500 | 85,726 | 189,781 | 257,511 | ||||||||||||
| Operating loss | (35,167 | ) | (68,724 | ) | (86,603 | ) | (166,789 | ) | ||||||||
| Other Income (Expense), Net | ||||||||||||||||
| Unrealized and realized appreciation in fair value of equity securities and preferred stock, net | 5,221 | 8,291 | ||||||||||||||
| Interest expense | (4,570 | ) | (4,542 | ) | (18,400 | ) | (17,666 | ) | ||||||||
| Interest and dividend income | 426 | 603 | 2,451 | 3,871 | ||||||||||||
| Other income (expense), net | (310 | ) | 2,774 | (165 | ) | 3,445 | ||||||||||
| Total other income (expense), net | (4,454 | ) | 4,056 | (16,114 | ) | (2,059 | ) | |||||||||
| Equity in net loss of affiliates | (13 | ) | (473 | ) | (1,138 | ) | (2,416 | ) | ||||||||
| Loss from continuing operations before income taxes | (39,634 | ) | (65,141 | ) | (103,855 | ) | (171,264 | ) | ||||||||
| Income tax benefit | (48 | ) | 905 | 82 | 930 | |||||||||||
| Loss from continuing operations | $ | (39,682 | ) | $ | (64,236 | ) | $ | (103,773 | ) | $ | (170,334 | ) | ||||
| Loss from discontinued operations, net of income tax benefit | (1,979 | ) | (104,979 | ) | (66,748 | ) | (153,582 | ) | ||||||||
| Net loss | $ | (41,661 | ) | $ | (169,215 | ) | $ | (170,521 | ) | $ | (323,916 | ) | ||||
| Net loss attributable to the noncontrolling interests | 1,592 | |||||||||||||||
| Net loss attributable to Precigen | $ | (41,661 | ) | $ | (169,215 | ) | $ | (170,521 | ) | $ | (322,324 | ) | ||||
| Amounts Attributable to Precigen | ||||||||||||||||
| Net loss from continuing operations attributable to Precigen | $ | (39,682 | ) | $ | (64,236 | ) | $ | (103,773 | ) | $ | (168,742 | ) | ||||
| Net loss from discontinued operations attributable to Precigen | (1,979 | ) | (104,979 | ) | (66,748 | ) | (153,582 | ) | ||||||||
| Net loss attributable to Precigen | $ | (41,661 | ) | $ | (169,215 | ) | $ | (170,521 | ) | $ | (322,324 | ) | ||||
| Net Loss per Share | ||||||||||||||||
| Net loss from continuing operations attributable to Precigen per share, basic and diluted | $ | (0.22 | ) | $ | (0.41 | ) | $ | (0.62 | ) | $ | (1.09 | ) | ||||
| Net loss from discontinued operations attributable to Precigen per share, basic and diluted | (0.01 | ) | (0.68 | ) | (0.40 | ) | (1.00 | ) | ||||||||
| Net loss attributable to Precigen per share, basic and diluted | $ | (0.23 | ) | $ | (1.09 | ) | $ | (1.02 | ) | $ | (2.09 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 178,225,571 | 155,230,741 | 167,065,539 | 154,138,774 |