On August 4, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported operating results for the second quarter 2017 and highlighted recent business and clinical progress (Press release, Epizyme, AUG 4, 2017, View Source [SID1234520030]).

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"Our focus throughout 2017 has been on executing important clinical and regulatory milestones across our tazemetostat program to enable us to bring this first-in-class agent to patients as quickly as we can," said Robert Bazemore, president and chief executive officer of Epizyme. "In addition, we have continued to pursue avenues to accelerate patient enrollment in our studies, including the recently established collaboration with US Oncology Research to support recruitment for our NHL study. We are also pleased to have reached key milestones in our solid tumor program, including completing enrollment in both our Phase 2 mesothelioma study and the epithelioid sarcoma cohort in our Phase 2 INI1-negative solid tumor study, and establishing the recommended dose in our Phase 1 study in children. We believe we have a significant opportunity with tazemetostat in hematological malignancies and solid tumors, and look forward to further evaluating its monotherapy and combination potential and engaging with FDA for our NHL program in the second half of the year."

Tazemetostat Clinical Program Updates

In July 2017, Epizyme completed enrollment in the epithelioid sarcoma (ES) cohort of its ongoing, multi-arm Phase 2 study in adult patients with INI1-negative solid tumors. Following the announcement of positive interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and discussion with the U.S. Food and Drug Administration, the company has identified a path to submission for accelerated approval for the treatment of patients with ES, and is targeting the first New Drug Application for tazemetostat in this indication in 2018.
In July 2017, Epizyme announced that the National Cancer Institute (NCI) initiated its Pediatric MATCH study, which will evaluate tazemetostat in one of the study arms as a monotherapy for pediatric patients with certain genetically defined solid tumors or non-Hodgkin lymphoma. This study is part of the company’s Cooperative Research and Development Agreement (CRADA) executed between Epizyme and the NCI.
In July 2017, the company established the recommended dose for tazemetostat in its study of pediatric patients with solid tumors, and initiated the dose-expansion portion of the study.
In June 2017, the company completed enrollment in its ongoing Phase 2 study designed to evaluate tazemetostat as a treatment for adults with mesothelioma characterized by BAP1 loss-of-function. The company expects to report data from this study in 2018.
In June 2017, Epizyme announced that tazemetostat will be evaluated in combination with atezolizumab (TECENTRIQ) in a Phase 1b/2 clinical study of metastatic non-small cell lung cancer as part of MORPHEUS, Genentech’s open-label, multi-center, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in solid tumors. This study is an expansion of the company’s clinical collaboration with Genentech, a member of the Roche Group, and is expected to begin enrolling patients by the end of the year.
In June 2017, positive interim efficacy data, grouped by EZH2 mutational status, were presented during a plenary session at the International Conference on Malignant Lymphoma (ICML) from the ongoing Phase 2 clinical trial of tazemetostat as a single-agent treatment for relapsed or refractory patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). Promising clinical activity and durability were observed across all study cohorts, with enhanced efficacy in the EZH2 mutation cohorts. Importantly, tazemetostat continues to demonstrate a favorable safety profile across the clinical development program.

Recent Business Highlights

In August 2017, Epizyme announced a collaboration with US Oncology Research to implement a separate screening protocol in 68 locations in the U.S. (including satellite locations affiliated with primary sites) to identify relapsed or refractory FL and DLBCL patients with tumors bearing EZH2 mutations who may be candidates for enrollment in Epizyme’s ongoing Phase 2 clinical trial. US Oncology Research will direct identified patients to the tazemetostat Phase 2 clinical trial for protocol screening and potential enrollment into the trial. Sites began screening patients in July 2017.
In June 2017, the U.S. FDA granted Orphan Drug designation to tazemetostat for the treatment of patients with soft tissue sarcoma (STS). Orphan Drug designation conveys eligibility for certain development incentives and market exclusivity for STS independent from Epizyme’s intellectual property protection.

Upcoming 2017 Milestones

Epizyme anticipates engaging with the U.S. FDA in the second half of 2017 to review data from its ongoing Phase 2 study in relapsed or refractory patients with NHL and discussing potential registration paths for tazemetostat.
The company plans to begin a clinical study evaluating tazemetostat as a combination agent for the treatment of patients with FL by the end of 2017.
Epizyme plans to announce the next development candidate from its novel, internally discovered pipeline of epigenetic programs by the end of 2017.
Second Quarter 2017 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $193.0 million as of June 30, 2017, as compared to $211.2 million as of March 31, 2017.
Revenue: $10.0 million was recognized in the second quarter of 2017, compared to $0.5 million for the second quarter of 2016. Revenue in the second quarter of 2017 represents a $10.0 million milestone payment from GlaxoSmithKline (GSK) following their initiation of GLP toxicology studies for a first-in-class methyltransferase inhibitor discovered by Epizyme and licensed to GSK.
R&D Expenses: Research and development (R&D) expenses were $27.3 million for the second quarter of 2017, compared to $21.5 million for the second quarter of 2016. The increase is primarily due to the expansion of the tazemetostat clinical development program, as well as increased research activities related to Epizyme’s next potential development candidate and new target families.
G&A Expenses: General and administrative (G&A) expenses were $11.2 million for the second quarter of 2017, compared to $7.4 million for the second quarter of 2016. The increase is primarily due to an increase in commercial-related activities and legal spending to support the company’s growing intellectual property portfolio.
Net Loss: Net loss was $28.0 million for each of the quarters ended June 30, 2017 and June 30, 2016.
2017 Financial Guidance
Epizyme believes, based on its current operating plan, that its cash, cash equivalents and marketable securities of $193.0 million as of June 30, 2017 will be sufficient to fund the Company’s planned operations into at least the third quarter of 2018.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL); certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma and combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for FL regardless of EZH2 mutation status and for DLBCL with EZH2-activating mutations, as well as Orphan Drug designation for soft tissue sarcoma and malignant rhabdoid tumors.

On August 3, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) and Molecular Templates, Inc. reported a collaboration agreement for oncology drug discovery programs (Press release, Takeda, AUG 3, 2017, View Source [SID1234520052]). The collaboration will apply Molecular Templates’ engineered toxin bodies (ETB) technology platform to potential therapeutic targets provided by Takeda through a joint scientific committee of both companies.

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"Over the past year, Takeda has expanded its collaborations in the Oncology space with the aim of accessing highly-innovative platforms to target specific tumor antigens using novel payloads and modality approaches," said Christopher Arendt, Ph.D., Head, Oncology DDU & Immunology Unit, Takeda. "In fact, we had already been working with the Molecular Templates team on a program that we have the option to in-license. The announcement of today’s collaboration with Molecular Templates allows us to extend this partnership and leverage their potentially groundbreaking approach to address additional tumors types, including solid tumors. The Molecular Templates team is outstanding, and we look forward to expanding our partnership."

Under the terms of the agreement, Takeda will make an equity investment and Molecular Templates is eligible to receive upfront payments, development and commercial milestone payments, Takeda has agreed to royalties on the sales of commercial products developed through the collaboration. Under the agreement, Takeda will also appoint a Director to Molecular Templates’ board of directors.

"This collaboration is an exciting opportunity to develop a new class of oncology therapeutics by applying our modified Shiga-like toxin fusion proteins to Takeda’s world-class oncology target portfolio," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Takeda’s oncology expertise and drug development capabilities represent unique assets for combination with our approach to targeting and destroying cancer cells, and we look forward to developing products via this new avenue of oncology research."

Takeda will have the right to exercise exclusive options to obtain license rights to products resulting from the collaboration. Molecular Templates would be responsible for manufacturing and supply of products licensed for development by Takeda through Phase I clinical development. Additional terms of the agreement are not being disclosed.

Takeda signed this agreement through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc.

About Molecular Templates
Molecular Templates is focused on the discovery, development and commercialization of next-generation immunotoxins called Engineered Toxin Bodies (ETBs) for the treatment of cancers and other serious diseases. For additional information, please visit the Company’s website at View Source;.

On August 3, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2017 and provided a business update (Press release, Regeneron, AUG 3, 2017, View Source [SID1234520050]).

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Financial Highlights

($ in millions, except per share data)

Three Months Ended
June 30,


2017

2016

% Change
EYLEA U.S. net product sales

$
919


$
831


11%
Total revenues

$
1,470


$
1,213


21%
GAAP net income

$
388


$
196


98%
GAAP net income per share – diluted

$
3.34


$
1.69


98%
Non-GAAP net income(2)

$
487


$
329


48%
Non-GAAP net income per share – diluted(2)

$
4.17


$
2.82


48%
"In the first half of 2017, we continued to bring our market-leading therapy EYLEA to more patients with retinal diseases, resulting in strong global sales. We also markedly expanded our positive impact on patient lives with two important new product launches for serious diseases, Dupixent for moderate-to-severe atopic dermatitis and Kevzara for moderately to severely active rheumatoid arthritis," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "The Dupixent U.S. launch in moderate-to-severe atopic dermatitis is proceeding well, with a very positive reception in the physician and patient community and strong commercial execution. In the second half of the year, we anticipate EU approval for Dupixent in atopic dermatitis, as well as Phase 3 study results and a potential U.S. regulatory submission for Dupixent in uncontrolled asthma."

Business Highlights

Marketed Product Update

EYLEA (aflibercept) Injection for Intravitreal Injection

In the second quarter of 2017, net sales of EYLEA in the United States increased 11% to $919 million from $831 million in the second quarter of 2016. Overall distributor inventory levels remained within the Company’s one- to two-week targeted range.
Bayer commercializes EYLEA outside the United States. In the second quarter of 2017, net sales of EYLEA outside of the United States(1) were $542 million, compared to $486 million in the second quarter of 2016. In the second quarter of 2017, Regeneron recognized $191 million from its share of net profit from EYLEA sales outside the United States, compared to $167 million in the second quarter of 2016.
Dupixent (dupilumab) Injection

Dupilumab, an antibody that blocks signaling of IL-4 and IL-13, is currently being studied in asthma, children with atopic dermatitis, nasal polyps, and eosinophilic esophagitis.
In the second quarter of 2017, global net sales of Dupixent were $29 million. Product sales for Dupixent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Dupixent. Sales of Dupixent in the second quarter largely reflect end-user demand and negligible contribution from inventory build.
In July 2017, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of Dupixent, recommending its approval for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
In the second quarter of 2017, a Phase 3 study of dupilumab in pediatric patients (6-11 years of age) with uncontrolled persistent asthma was initiated.
Praluent (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol

In the second quarter of 2017, global net sales of Praluent were $46 million, compared to $24 million in the second quarter of 2016. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent.
In April 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for a once-monthly (every four weeks), 300 mg dose of Praluent.
In the second quarter of 2017, the FDA granted orphan drug designation for the treatment of homozygous familial hypercholesterolemia (HoFH).
In June 2017, the Company and Sanofi announced that two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes met their primary endpoints.
The ODYSSEY OUTCOMES trial, which is assessing the potential of Praluent to demonstrate cardiovascular benefit, remains ongoing.
Kevzara (sarilumab) Injection

In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response or intolerance to one or more disease modifying anti-rheumatic drugs (DMARDs).
In June 2017, the European Commission granted marketing authorization for Kevzara in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; Kevzara may be used as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
Pipeline Progress

Regeneron has seventeen product candidates in clinical development, which consist of EYLEA and fully human monoclonal antibodies generated using the Company’s VelocImmune technology, including six in collaboration with Sanofi. In addition to EYLEA, Dupixent (dupilumab), Praluent, and Kevzara (sarilumab) discussed above, updates from the clinical pipeline include:

REGN2810, an antibody to programmed cell death protein 1 (PD-1), is being studied in patients with cancer.

In June 2017, the Company and Sanofi presented, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, positive preliminary results from data in patients with advanced cutaneous squamous cell carcinoma (CSCC) pooled from two expansion cohorts of the REGN2810 Phase 1 trial. A pivotal Phase 2 study in CSCC is ongoing.
A Phase 3 study in first-line treatment for non-small cell lung cancer was initiated in the second quarter of 2017.
A potentially pivotal Phase 2 study in basal cell carcinoma was initiated in the second quarter of 2017.
Fasinumab is an antibody targeting Nerve Growth Factor (NGF). A Phase 3 efficacy study in patients with pain due to osteoarthritis of the knee or hip was initiated in the second quarter of 2017.

Evinacumab, an antibody to Angptl-3, is in clinical development for the treatment of HoFH and severe forms of hyperlipidemia.

In May 2017, the Company announced that the Phase 2 study in patients with HoFH met its primary endpoint.
In May 2017, an analysis published in the New England Journal of Medicine showed that people with inactivating mutations of the ANGPTL3 gene have significantly reduced risk of coronary artery disease and significantly lower levels of key blood lipids including triglycerides and low-density lipoprotein cholesterol (LDL-C, or "bad cholesterol").
REGN1979, a bispecific antibody to CD20 and CD3, received orphan drug designation from the FDA in diffuse large B-cell lymphoma.

REGN2477, an antibody to Activin A, received Fast Track designation from the FDA for the prevention and treatment of heterotopic ossification in patients with Fibrodysplasia Ossificans Progressiva (FOP) in the second quarter of 2017.

REGN3918, an antibody to complement 5 (C5), is being developed for paroxysmal nocturnal hemoglobinuria (PNH). A Phase 1 clinical study in healthy volunteers was initiated in the second quarter of 2017.

Select Upcoming 2017 Milestones

Programs

Milestones
EYLEA
•
Submit sBLA to FDA for every 12-week dosing interval in neovascular age-related macular degeneration (wet AMD)
Dupixent
•
Submission for additional regulatory approvals in atopic dermatitis outside of the United States
•
Regulatory agency decision on atopic dermatitis in the European Union
•
Report results from Phase 3 asthma program in adults and adolescents
•
Submit sBLA for asthma in adult/adolescent patients
•
Initiate Phase 3 studies in pediatric patients in atopic dermatitis
Praluent
•
Complete ODYSSEY OUTCOMES study (with data expected in early 2018)
Kevzara
•
Submission for additional regulatory approvals and regulatory agency decisions on applications outside of the United States
Suptavumab (REGN2222; RSV-F Antibody)
•
Report results from Phase 3 study
REGN2810 (PD-1 Antibody)
•
Initiate Phase 3 study in cervical cancer
Fasinumab (NGF Antibody)
•
Initiate Phase 3 study in chronic low back pain
Nesvacumab/aflibercept (Ang2 Antibody co-formulated with aflibercept)
•
Report data from Phase 2 studies in DME (RUBY) and wet AMD (ONYX)
REGN2477 (Activin A Antibody)
•
Initiate Phase 2 study in patients with FOP
Business Development Update

In the second quarter of 2017, the Company entered into clinical study agreements with Inovio Pharmaceuticals, Inc. and SillaJen, Inc. to evaluate REGN2810 in combination with their respective product candidates.
The Company’s Antibody Discovery Agreement with Sanofi will end on December 31, 2017 without any extension. Praluent (anti-PCSK9), Dupixent (anti-IL-4R), Kevzara (anti-IL-6R), REGN2810 (anti-PD-1), REGN3500 (anti-IL-33), and REGN3767 (anti-LAG-3) were discovered and initially developed under the Antibody Discovery Agreement. Praluent, Dupixent, Kevzara, and REGN3500 will continue to be developed, and commercialized as applicable, with Sanofi under the Antibody License and Collaboration Agreement. REGN2810 and REGN3767 will continue to be developed with Sanofi under the immuno-oncology collaboration. Upon expiration of the Antibody Discovery Agreement, Regeneron has the right to develop or continue to develop other product candidates discovered under this agreement independently or with other collaborators. The $130 million of 2017 annual funding from Sanofi under the Antibody Discovery Agreement is expected to be fully utilized by the end of the third quarter of 2017.
Second Quarter 2017 Financial Results

Product Revenues: Net product sales were $924 million in the second quarter of 2017, compared to $834 million in the second quarter of 2016. EYLEA net product sales in the United States were $919 million in the second quarter of 2017, compared to $831 million in the second quarter of 2016.

Total Revenues: Total revenues, which include product revenues described above, increased by 21% to $1.470 billion in the second quarter of 2017, compared to $1.213 billion in the second quarter of 2016. Total revenues include Sanofi and Bayer collaboration revenues of $432 million in the second quarter of 2017, compared to $355 million in the second quarter of 2016. Sanofi collaboration revenue in the second quarter of 2017 increased primarily due to Sanofi’s reimbursement of immuno-oncology research and development costs in connection with the advancement of REGN2810 and other product candidates. Total revenues in the second quarter of 2017 also include (i) reimbursement of the Company’s research and development expenses in connection with its collaboration agreement with Teva that was entered into in September 2016, and (ii) the recognition of two development milestones in connection with fasinumab of $25.0 million and $30.0 million from Teva and Mitsubishi Tanabe Pharma, respectively.

Refer to Table 4 for a summary of collaboration and other revenue.

Research and Development (R&D) Expenses: GAAP R&D expenses were $510 million in the second quarter of 2017, compared to $560 million in the second quarter of 2016. The lower R&D expenses in the second quarter of 2017 were principally due to a $75 million up-front payment made in connection with the license and collaboration agreement with Intellia in the second quarter of 2016, partly offset by an increase in REGN2810 clinical trial costs. In addition, in the second quarter of 2017, R&D-related non-cash share-based compensation expense was $70 million, compared to $79 million in the second quarter of 2016.

Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $307 million in the second quarter of 2017, compared to $292 million in the second quarter of 2016. In the second quarter of 2017, SG&A-related non-cash share-based compensation expense was $45 million, compared to $48 million in the second quarter of 2016.

Cost of Collaboration and Contract Manufacturing (COCM): GAAP COCM was $61 million in the second quarter of 2017, compared to $28 million in the second quarter of 2016. COCM includes costs incurred in connection with producing commercial drug supplies and validating the Company’s commercial facilities in connection with its Sanofi and Bayer collaborations. COCM also included inventory write-offs and reserves totaling $31 million in the second quarter of 2017.

Other (Expense) Income, Net: Other expense in the second quarter of 2017 included an out-of-period adjustment which resulted in the recognition of a non-cash, loss on debt extinguishment charge of $30.1 million in connection with the Company’s March 2017 Tarrytown lease transaction.

Income Tax Expense: In the second quarter of 2017, GAAP income tax expense was $138 million and the effective tax rate was 26.3%, compared to $96 million and 32.9% in the second quarter of 2016. The effective tax rate for the second quarter of 2017 was positively impacted, compared to the U.S. federal statutory rate, by the tax benefit associated with stock-based compensation, the domestic manufacturing deduction, and the federal tax credit for research activities, partly offset by losses incurred in foreign jurisdictions with rates lower than the federal statutory rate and the non-tax deductible Branded Prescription Drug Fee.

GAAP and Non-GAAP Net Income(2): The Company reported GAAP net income of $388 million, or $3.66 per basic share and $3.34 per diluted share, in the second quarter of 2017, compared to GAAP net income of $196 million, or $1.88 per basic share and $1.69 per diluted share, in the second quarter of 2016.

The Company reported non-GAAP net income of $487 million, or $4.59 per basic share and $4.17 per diluted share, in the second quarter of 2017, compared to non-GAAP net income of $329 million, or $3.15 per basic share and $2.82 per diluted share, in the second quarter of 2016.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

2017 Financial Guidance(3)

The Company’s updated full year 2017 financial guidance consists of the following components:

EYLEA U.S. net product sales
Approximately 10% growth over 2016
(previously single digit percentage growth over 2016)
Sanofi reimbursement of Regeneron commercialization-related expenses
$370 million – $400 million
(previously $385 million – $425 million)
Non-GAAP unreimbursed R&D(2)(4)
$925 million – $965 million
(previously $950 million – $1.025 billion)
Non-GAAP SG&A(2)(4)
$1.12 billion – $1.16 billion
(previously $1.14 billion – $1.20 billion)
Effective tax rate
27% – 31%
(previously 32% – 38%)
Capital expenditures
$250 million – $285 million
(previously $300 million – $350 million)


(1)
Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer collaboration revenue" in its Statements of Operations.


(2)
This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the income tax effect of reconciling items.



The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control, such as the Company’s stock price on the dates share-based grants are issued. Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company’s historical GAAP to non-GAAP results is included in Table 3 of this press release.


(3)
The Company’s 2017 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release and assumes that Praluent will remain on the market throughout 2017.


(4)
A reconciliation of full year 2017 non-GAAP to GAAP financial guidance is included below:






Projected Range


(In millions)

Low

High


GAAP unreimbursed R&D (5)

$
1,205


$
1,265



R&D: Non-cash share-based compensation expense

(280)


(300)



Non-GAAP unreimbursed R&D

$
925


$
965










GAAP SG&A

$
1,325


$
1,395



SG&A: Non-cash share-based compensation expense

(205)


(235)



Non-GAAP SG&A

$
1,120


$
1,160



(5)
Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company’s collaborators and/or customers.