Le Lézard
Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Alnylam Pharmaceuticals Reports Second Quarter 2020 Financial Results and Highlights Recent Period Activity


Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the second quarter 2020 and reviewed recent business highlights.

"In the second quarter of 2020, the world experienced unprecedented challenges as it continued to confront the COVID-19 pandemic. While the pandemic continues in some countries and states, our global commercialization strategy is now enabling some customer-facing activities to resume in most markets as we enter the third quarter. We are very pleased with our ONPATTRO and GIVLAARI commercial performance in the second quarter, in the face of the ongoing pandemic, and believe it reflects strong demand for our products as well as our team's unwavering commitment to assure access to these RNAi therapeutics for patients around the world," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "In the quarter, we also continued advancing our robust late-stage pipeline of investigational RNAi therapeutics, where, notably, we presented full results from the ILLUMINATE-A Phase 3 study and completed regulatory filings for lumasiran, and continued enrollment in our APOLLO-B and HELIOS-B Phase 3 studies of patisiran and vutrisiran, respectively. Further, a key business highlight in the second quarter was our completion of a landmark strategic financing collaboration with Blackstone, which we believe will secure our ability to achieve a self-sustainable financial profile without the need for future equity financing. These and other achievements position us to realize our Alnylam 2020 vision of building a multi-product, global biopharma company with a deep clinical pipeline to fuel continued growth and a robust, organic product engine to drive sustainable innovation and further value creation."

Second Quarter 2020 and Recent Significant Corporate Highlights

Commercial Performance

ONPATTRO®

GIVLAARI®

R&D Highlights

Additional Business Updates

Upcoming Events

In mid- and late 2020, Alnylam intends to:

Financial Results for the Quarter Ended June 30, 2020

"We are extremely pleased with our financial results for the second quarter, particularly in the face of these challenging circumstances. Our team's ability to swiftly adapt to virtual engagement with stakeholders and to support the transition of patients, where needed, to alternate sites of care, in addition to strong international results, led to commercial performance for both ONPATTRO and GIVLAARI that exceeded the initial expectations we communicated in May 2020. As a result, we are further revising our full-year revenue guidance for ONPATTRO, with an increase in the midpoint of our guidance as we narrow the range from $270-$300 million to $280-$300 million," said Jeff Poulton, Chief Financial Officer of Alnylam. "Outside of our commercial performance, a key business highlight in the second quarter was our achievement of year-over-year improvement in our non-GAAP operating loss versus 2019. Driven by strong top-line year-over-year growth and disciplined investment in our operations, we continue to believe 2019 represents our peak operating loss year as we begin our journey towards a self-sustainable financial profile. In summary, we believe that we're well positioned to effectively navigate through the pandemic and continue to deliver on the promise of RNAi therapeutics, bringing transformative therapies to patients with serious diseases around the world."

Financial Highlights

(in thousands, except per share amounts)

 

Three Months Ended June 30,

 

2020

 

2019

 

 

 

 

Net product revenues

$

77,533

 

 

$

38,231

 

ONPATTRO net product revenues

$

66,535

 

 

$

38,231

 

GIVLAARI net product revenues

$

10,998

 

 

$

?

 

 

 

 

 

Net revenue from collaborations

$

26,429

 

 

$

6,483

 

 

 

 

 

Cost of goods sold

$

19,929

 

 

$

4,326

 

 

 

 

 

GAAP research and development expenses

$

154,996

 

 

$

163,890

 

Non-GAAP research and development expenses

$

139,206

 

 

$

148,608

 

 

 

 

 

GAAP selling, general and administrative expenses

$

127,896

 

 

$

112,769

 

Non-GAAP selling, general and administrative expenses

$

109,611

 

 

$

97,448

 

 

 

 

 

GAAP operating loss

$

(198,859)

 

 

$

(236,271)

 

Non-GAAP operating loss

$

(164,784)

 

 

$

(205,668)

 

 

 

 

 

GAAP net loss

$

(179,229)

 

 

$

(219,481)

 

Non-GAAP net loss

$

(191,328)

 

 

$

(198,300)

 

 

 

 

 

GAAP net loss per common share - basic and diluted

$

(1.56)

 

 

$

(2.02)

 

Non-GAAP net loss per common share - basic and diluted

$

(1.67)

 

 

$

(1.83)

 

 

 

 

 

 

 

 

 

 

June 30, 2020

 

December 31, 2019

Cash, cash equivalents, marketable debt and equity
securities and restricted investments

$

1,950,289

 

 

$

1,550,987

 

Net Product Revenues

Net Revenues from Collaborations

Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses

Cash and Investments

A reconciliation of our GAAP to non-GAAP results for the current quarter is included in the tables of this press release.

2020 Updated Financial Guidance

Full year 2020 financial guidance consists of the following:

Item

 

Provided 5/6/2020
($ millions)

 

Updated 8/6/2020
($ millions)

ONPATTRO net product revenues

 

$270 - $300

 

$280 - $300

GIVLAARI net product revenues

 

No guidance provided

 

Unchanged

Net revenues from collaborations

 

$100 - $150

 

Unchanged

GAAP R&D and SG&A expenses

 

$1,155 - $1,250

 

$1,130 - $1,225

Non-GAAP R&D and SG&A expenses*

 

$1,000 - $1,075

 

Unchanged

 

 

 

 

 

*Excludes $130-$150 million (previously $155-175 million) of stock-based compensation and costs associated with the strategic financing collaboration from estimated GAAP R&D and SG&A expenses.

The strategic financing collaboration with Blackstone under which Alnylam will receive up to $2 billion is expected to enable Alnylam's achievement of a self-sustainable financial profile without need for future equity financings.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses and non-recurring gains outside the ordinary course of the Company's business. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in the press release are stock-based compensation expenses, unrealized gain on marketable equity securities, costs associated with our strategic financing collaboration, a gain on contractual settlement, and a gain on the change in fair value of a liability obligation. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company's stock price, which impacts the fair value of these awards. The Company has excluded the impact of the unrealized gain on marketable equity securities, costs associated with our strategic financing collaboration, the gain on contractual settlement, and a gain on the change in fair value of a liability obligation because the Company believes these items are non-recurring transactions outside the ordinary course of the Company's business.

The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company's financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company's ongoing operating performance and are better able to compare the Company's performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between GAAP and non-GAAP measures is provided later in this press release.

Conference Call Information

Management will provide an update on the Company and discuss second quarter 2020 results as well as expectations for the future via conference call on Thursday, August 6, 2020 at 8:30 am ET. To access the call, please dial 800-239-9838 (domestic) or +1-323-794-2551 (international) five minutes prior to the start time and refer to conference ID 6976021. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or +1-719-457-0820 (international) and refer to conference ID 6976021.

A live audio webcast of the call will be available on the Investors section of the Company's website at www.alnylam.com/events. An archived webcast will be available on the Alnylam website approximately two hours after the event.

About ONPATTRO® (patisiran)

ONPATTRO is an RNAi therapeutic that was approved in the United States and Canada for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved in the European Union, Switzerland and Brazil for the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and in Japan for the treatment of hATTR amyloidosis with polyneuropathy. ONPATTRO is an intravenously administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby blocking the production of TTR protein before it is made. ONPATTRO blocks the production of TTR in the liver, reducing its accumulation in the body's tissues in order to halt or slow down the progression of the polyneuropathy associated with the disease. For more information about ONPATTRO, visit ONPATTRO.com.

ONPATTRO Important Safety Information

Infusion-Related Reactions

Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO® (patisiran). In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache.

To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. Monitor patients during the infusion for signs and symptoms of IRRs. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.

Reduced Serum Vitamin A Levels and Recommended Supplementation

ONPATTRO treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking ONPATTRO. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with ONPATTRO, as serum levels do not reflect the total vitamin A in the body.

Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g. night blindness).

Adverse Reactions

The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion-related reactions (19%).

For additional information about ONPATTRO, please see the full Prescribing Information.

About GIVLAARI® (givosiran)

GIVLAARI is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) approved in the United States and Brazil for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is also approved in the European Union for the treatment of AHP in adults and adolescents aged 12 years and older. In the pivotal study, givosiran was shown to significantly reduce the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or intravenous hemin administration at home compared to placebo. GIVLAARI is Alnylam's first commercially available therapeutic based on its Enhanced Stabilization Chemistry ESC-GalNAc conjugate technology to increase potency and durability. GIVLAARI is administered via subcutaneous injection once monthly at a dose based on actual body weight and should be administered by a healthcare professional. GIVLAARI works by specifically reducing elevated levels of aminolevulinic acid synthase 1 (ALAS1) messenger RNA (mRNA), leading to reduction of toxins associated with attacks and other disease manifestations of AHP. For more information about GIVLAARI, visit GIVLAARI.com.

GIVLAARI Important Safety Information

Contraindications

GIVLAARI is contraindicated in patients with known severe hypersensitivity to givosiran. Reactions have included anaphylaxis.

Anaphylactic Reaction

Anaphylaxis has occurred with GIVLAARI treatment (<1% of patients in clinical trials). Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI. Monitor for signs and symptoms of anaphylaxis. If anaphylaxis occurs, immediately discontinue administration of GIVLAARI and institute appropriate medical treatment.

Hepatic Toxicity

Transaminase elevations (ALT) of at least 3 times the upper limit of normal (ULN) were observed in 15% of patients receiving GIVLAARI in the placebo-controlled trial. Transaminase elevations primarily occurred between 3 to 5 months following initiation of treatment.

Measure liver function tests prior to initiating treatment with GIVLAARI, repeat every month during the first 6 months of treatment, and as clinically indicated thereafter. Interrupt or discontinue treatment with GIVLAARI for severe or clinically significant transaminase elevations. In patients who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly. The dose may be increased to the recommended dose of 2.5 mg/kg once monthly if there is no recurrence of severe or clinically significant transaminase elevations at the 1.25 mg/kg dose.

Renal Toxicity

Increases in serum creatinine levels and decreases in estimated glomerular filtration rate (eGFR) have been reported during treatment with GIVLAARI. In the placebo-controlled study, 15% of patients receiving GIVLAARI experienced a renally-related adverse reaction. The median increase in creatinine at Month 3 was 0.07 mg/dL. Monitor renal function during treatment with GIVLAARI as clinically indicated.

Injection Site Reactions

Injection site reactions were reported in 25% of patients receiving GIVLAARI in the placebo-controlled trial. Symptoms included erythema, pain, pruritus, rash, discoloration, or swelling around the injection site. One (2%) patient experienced a single, transient, recall reaction of erythema at a prior injection site with a subsequent dose administration.

Drug Interactions

Concomitant use of GIVLAARI increases the concentration of CYP1A2 or CYP2D6 substrates, which may increase adverse reactions of these substrates. Avoid concomitant use of GIVLAARI with CYP1A2 or CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP1A2 or CYP2D6 substrate dosage in accordance with approved product labeling.

Adverse Reactions

The most common adverse reactions that occurred in patients receiving GIVLAARI were nausea (27%) and injection site reactions (25%).

For additional information about GIVLAARI, please see full Prescribing Information.

About LNP Technology

Alnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of today's medicines by potently silencing messenger RNA (mRNA) ? the genetic precursors ? that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam's commercial RNAi therapeutic products are ONPATTRO® (patisiran), approved in the U.S., EU, Canada, Japan, Switzerland and Brazil, and GIVLAARI® (givosiran), approved in the U.S., EU and Brazil. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its "Alnylam 2020" strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

Alnylam Forward Looking Statements

Various statements in this release concerning Alnylam's expectations, plans and prospects, including, without limitation, expectations regarding the direct or indirect effects on Alnylam's business, activities and prospects as a result of the COVID-19 pandemic, or delays or interruptions resulting therefrom and the success of Alnylam's mitigation efforts, Alnylam's views and plans with respect to the potential for RNAi therapeutics, including ONPATTRO, GIVLAARI, lumasiran, patisiran, vutrisiran, inclisiran, fitusiran, cemdisiran, ALN-HBV02, ALN-AGT, ALN-HSD, ALN-COV and ALN-APP, its plans for additional global regulatory filings and the continuing product launches of ONPATTRO and GIVLAARI, expectations regarding reimbursement for ONPATTRO and GIVLAARI in various territories and the status of VBA negotiations and executed agreements, its expectations regarding continued progress supporting pre-approval access to GIVLAARI in its EAP program, the advancement of lumasiran and inclisiran through regulatory review and toward the market, the expected timing for the presentation of topline ILLUMINATE-B Phase 3 results for lumasiran, the achievement of additional pipeline milestones, including relating to ongoing clinical studies of vutrisiran, the expected timing for filing INDs or CTAs for ALN-COV and ALN-APP, the initiation of Phase 1 clinical studies of ALN-HSD by Alnylam and cemdisiran and pozelimab by Regeneron, its expectations relating to continued ONPATTRO and GIVLAARI revenue growth and the further revised expected range of ONPATTRO net product revenues for 2020, the expected range for net revenues from collaborations for 2020, the revised expected range of 2020 aggregate annual non-GAAP and GAAP R&D and SG&A expenses, Alnylam's belief that the funding provided by Blackstone should enable Alnylam to achieve a self-sustainable profile without the need for future equity financing, and expectations regarding the achievement of its "Alnylam 2020" strategic plan announced in 2015 for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation: the direct or indirect impact of the COVID-19 global pandemic or any future pandemic, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses of rare diseases, initiation or continuation of treatment for diseases addressed by Alnylam products, or in patient enrollment in clinical trials, potential supply chain disruptions, and other potential impacts to Alnylam's business, the effectiveness or timeliness of steps taken by Alnylam to mitigate the impact of the pandemic, and Alnylam's ability to execute business continuity plans to address disruptions caused by the COVID-19 or any future pandemic; Alnylam's ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates, including vutrisiran, ALN-AGT, ALN-HSD, ALN-APP and ALN-COV; the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all; actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing; delays, interruptions or failures in the manufacture and supply of its product candidates or its marketed products, including ONPATTRO, GIVLAARI, inclisiran, lumasiran and vutrisiran; obtaining, maintaining and protecting intellectual property; intellectual property matters including potential patent litigation relating to its platform, products or product candidates; obtaining regulatory approval for its product candidates, including lumasiran and inclisiran, and maintaining regulatory approval and obtaining pricing and reimbursement for its products, including ONPATTRO and GIVLAARI; progress in continuing to establish a commercial and ex-United States infrastructure; successfully launching, marketing and selling its approved products globally, including ONPATTRO and GIVLAARI and achieving net product revenues for ONPATTRO within its further revised expected range during 2020; Alnylam's ability to successfully expand the indication for ONPATTRO in the future; competition from others using technology similar to Alnylam's and others developing products for similar uses; Alnylam's ability to manage its growth and operating expenses within the reduced ranges of guidance provided by Alnylam through the implementation of further discipline in operations to moderate spend and its ability to achieve a self-sustainable financial profile in the future without the need for future equity financing; Alnylam's ability to establish and maintain strategic business alliances and new business initiatives, including completing an agreement for funding by Blackstone of certain R&D activities for vutrisiran and ALN-AGT; Alnylam's dependence on third parties, including Regeneron, for development, manufacture and distribution of certain products, including eye and CNS products and ALN-APP, Ironwood, for assistance with the education about and promotion of GIVLAARI, and Vir for the development of ALN-COV and other potential RNAi therapeutics targeting SARS-CoV-2 and host factors for SARS-CoV-2; the outcome of litigation; the risk of government investigations; and unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

ALNYLAM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)

 

Three Months Ended

 

Six Months Ended

 

June 30,
2020

 

June 30,
2019

 

June 30,
2020

 

June 30,
2019

 

Statements of Operations

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

Net product revenues

$

77,533

 

 

$

38,231

 

 

$

149,471

 

 

$

64,522

 

 

Net revenues from collaborations

26,429

 

 

6,483

 

 

53,967

 

 

13,486

 

 

Total revenues

103,962

 

 

44,714

 

 

203,438

 

 

78,008

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

Cost of goods sold

$

19,929

 

 

$

4,326

 

 

$

33,231

 

 

$

7,673

 

 

Research and development

154,996

 

 

163,890

 

 

324,567

 

 

293,017

 

 

Selling, general and administrative

127,896

 

 

112,769

 

 

254,657

 

 

202,377

 

 

Total operating costs and expenses

302,821

 

 

280,985

 

 

612,455

 

 

503,067

 

 

Loss from operations

(198,859)

 

 

(236,271)

 

 

(409,017)

 

 

(425,059)

 

 

Other income:

 

 

 

 

 

 

 

 

Interest expense

(27,248)

 

 

?

 

 

(27,248)

 

 

?

 

 

Interest income

3,165

 

 

8,781

 

 

8,645

 

 

16,306

 

 

Other income (expense)

45,039

 

 

(453)

 

 

68,071

 

 

(410)

 

 

Change in fair value of liability obligation

?

 

 

9,422

 

 

?

 

 

9,422

 

 

Total other income

20,956

 

 

17,750

 

 

49,468

 

 

25,318

 

 

Loss before income taxes

(177,903)

 

 

(218,521)

 

 

(359,549)

 

 

(399,741)

 

 

Provision for income taxes

(1,326)

 

 

(960)

 

 

(1,901)

 

 

(1,655)

 

 

Net loss

$

(179,229)

 

 

$

(219,481)

 

 

$

(361,450)

 

 

$

(401,396)

 

 

Net loss per common share - basic and diluted

$

(1.56)

 

 

$

(2.02)

 

 

$

(3.18)

 

 

$

(3.75)

 

 

Weighted-average common shares used to compute
basic and diluted net loss per common share

114,911

 

 

108,576

 

 

113,830

 

 

106,997

 

 

 

 

 

 

 

 

 

 

 

ALNYLAM PHARMACEUTICALS, INC.
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES
(In thousands, except per share amounts)

 

Three Months Ended

 

June 30, 2020

 

June 30, 2019

Reconciliation of GAAP to Non-GAAP research and development:

 

 

 

GAAP Research and development

154,996

 

 

163,890

 

Less: Stock-based compensation expenses

(15,790)

 

 

(15,282)

 

Non-GAAP Research and development

139,206

 

 

148,608

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP selling, general and
administrative:

 

 

 

GAAP Selling, general and administrative

127,896

 

 

112,769

 

Less: Stock-based compensation expenses

(17,965)

 

 

(15,321)

 

Less: Costs associated with the strategic financing collaboration

(320)

 

 

?

 

Non-GAAP Selling, general and administrative

109,611

 

 

97,448

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP operating loss:

 

 

 

GAAP operating loss

(198,859)

 

 

(236,271)

 

Add: Stock-based compensation expenses

33,755

 

 

30,603

 

Add: Costs associated with the strategic financing collaboration

320

 

 

?

 

Non-GAAP operating loss

(164,784)

 

 

(205,668)

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP net loss:

 

 

 

GAAP net loss

(179,229)

 

 

(219,481)

 

Add: Stock-based compensation expenses

33,755

 

 

30,603

 

Add: Costs associated with the strategic financing collaboration

320

 

 

?

 

Less: Unrealized gain on marketable equity securities

(45,532)

 

 

?

 

Less: Gain on contractual settlement

(642)

 

 

?

 

Less: Change in Fair value of liability contribution

?

 

 

(9,422)

 

Non-GAAP net loss

(191,328)

 

 

(198,300)

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP net loss per common share-
basic and diluted:

 

 

 

GAAP net loss per common share - basic and diluted

(1.56)

 

 

(2.02)

 

Add: Stock-based compensation expenses

0.29

 

 

0.28

 

Add: Costs associated with the strategic financing collaboration

?

 

 

?

 

Less: Unrealized gain on marketable equity securities

(0.39)

 

 

?

 

Less: Gain on contractual settlement

(0.01)

 

 

?

 

Less: Change in Fair value of liability contribution

?

 

 

(0.09)

 

Non-GAAP net loss per common share - basic and diluted

(1.67)

 

 

(1.83)

 

 

 

 

 

Please note that the figures presented above may not sum exactly due to rounding

ALNYLAM PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
(Unaudited)

 

 

 

 

June 30, 2020

December 31, 2019

Cash, cash equivalents and marketable debt and equity securities

$

1,925,564

 

$

1,536,162

 

Restricted investments

24,725

 

14,825

 

Accounts receivable, net

69,115

 

43,011

 

Inventory

77,418

 

56,348

 

Prepaid expenses and other assets

108,745

 

98,412

 

Property, plant and equipment, net

439,126

 

425,179

 

Operating lease right-of-use lease assets

229,674

 

221,197

 

Receivable related to the sale of future royalties

500,000

 

?

 

Total assets

$

3,374,367

 

$

2,395,134

 

Accounts payable, accrued expenses and other liabilities

$

256,166

 

$

256,415

 

Total deferred revenue

389,117

 

396,204

 

Operating lease liability

315,065

 

303,823

 

Liability related to the sale of future royalties

1,014,293

 

?

 

Total stockholders' equity (115.6 million shares issued and
outstanding at June 30, 2020; 112.2 million shares issued and
outstanding at December 31, 2019)

1,399,726

 

1,438,692

 

Total liabilities and stockholders' equity

$

3,374,367

 

$

2,395,134

 

This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alnylam's Annual Report on Form 10-K which includes the audited financial statements for the year ended December 31, 2019.


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