IPO Report: Voyager Therapeutics (VYGR)

Francis Gaskins |

Voyager Therapeutics (VYGR) is a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe diseases of the central nervous system, or CNS. The company is based in Cambridge, MA.

Five other companies are scheduled for the week of Nov 9. The full IPO calendar is available at IPO Premium.

SEC Documents

Manager, Joint-managers: Cowen and Company, Piper Jaffray, Wedbush PacGrow, Nomura
Co-managers: None

End of lockup (180 days): Monday, May 9, 2016
End of 25-day quiet period: Sunday, December 6, 2015

VYGR scheduled a $75 million IPO with a market capitalization of $412 million at a price range midpoint of $16 for Wednesday, Nov. 11 2015 on Nasdaq.

Summary

VYGR is a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe diseases of the central nervous system, or CNS.

VYGR focuses on CNS diseases where it believes that an adeno-associated virus, or AAV, gene therapy approach that either increases or decreases the production of a specific protein can slow or reduce the symptoms experienced by patients, and therefore have a clinically meaningful impact.

Valuation

Glossary

Accumulated deficit (mm)

.

.

-$39

     

Per share dilution

.

.

-$8.68

     
             

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

Voyager Therapeutics (VYGR)

$411

27.4

-11.1

2.4

2.2

18%

             

 

 

 

 

 

 

 

Conclusion

Neutral

Shareholders not buying

P/E of -11.1, indicating fairly heavy cah burn rate relative to market cap

Price to book of 2.4

Genzyme Collaboration

Business

VYGR is a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe diseases of the central nervous system, or CNS.

VYGR focuses on CNS diseases where it believes that an adeno-associated virus, or AAV, gene therapy approach that either increases or decreases the production of a specific protein can slow or reduce the symptoms experienced by patients, and therefore have a clinically meaningful impact.

VYGR has created a product engine that enables it to engineer, optimize, manufacture and deliver its AAV-based therapies that have the potential to provide durable efficacy following a single administration directly to the CNS.

VYGR’s product engine has rapidly generated programs for five CNS indications, including advanced Parkinson's disease; a monogenic form of amyotrophic lateral sclerosis, or a form of the disease caused by a single gene mutation; Friedreich's ataxia; Huntington's disease; and spinal muscular atrophy.

Genzyme Collaboration

For the six months ended June 30, 2015, VYGR recognized $7.5 million of collaboration revenue from the Genzyme Collaboration

Under the collaboration agreement with Genzyme, VYGR granted Genzyme an exclusive option to license, develop and commercialize ex-U.S. rights to the advanced Parkinson's disease program, the Friedreich's ataxia program, a future program to be designated by Genzyme and our Huntington's disease program.

Additionally, VYGR granted Genzyme an incremental option to co-commercialize our Huntington's disease program in the United States and to worldwide rights to VYGR's spinal muscular atrophy program.

If Genzyme exercises any of these options, except for VYGR's advanced Parkinson's disease program, VYGR would be eligible to receive specified option fees.

Proof of Concept

VYGR’s most advanced clinical candidate, VY-AADC01, is being evaluated for the treatment of advanced Parkinson's disease in an open-label, Phase 1b clinical trial with the goal of generating human proof-of-concept data in the second half of 2016.

VYGR’s founders and members of its management team have extensive experience in drug discovery and development and have pioneered significant advances within the fields of AAV gene therapy and neuroscience.

AAV Gene Therapy

VYGR believes that AAV gene therapy is a particularly attractive treatment approach for CNS diseases that are caused by well-defined genetic mutations.

CNS diseases are a leading driver of global disease burden and represent the single largest biopharmaceutical market with estimated worldwide annual sales of over $125 billion in 2013, with the five CNS indications that VYGR is currently targeting representing only a portion of this market.

Due to the limited treatment options available for many CNS diseases, there remains a significant unmet medical need and an opportunity for AAV gene therapy to transform the lives of many patients with severe CNS diseases. Based upon clinical data generated to date,

VYGR believes that durable gene expression is achievable following a single administration of AAV gene therapy.

Recent advances in delivery techniques allow for targeted delivery of AAV vectors, which are modified, non-replicating versions of AAV, to discrete regions of the CNS.

In addition, AAV is believed to be safe, as no vector-related serious adverse events, or SAEs, have been reported in the more than 1,300 patients that VYGR estimates have been treated with AAV gene therapy to date, including 200 patients treated for CNS indications.

Product engine
VYGR has built a product engine that it believes positions it to be the leading company at the intersection of AAV gene therapy and severe CNS diseases.

VYGR’s team of experts in the fields of AAV gene therapy and neuroscience first identifies and selects severe CNS diseases that are well-suited for treatment using AAV gene therapy.

VYGR then engineers and optimizes AAV vectors for delivery to the targeted tissue or cells. VYGR’s manufacturing process employs an established system to enable production of high quality AAV vectors at commercial-scale.

Finally, VYGR leverages established routes of administration and advances in dosing techniques to optimize delivery of its AAV gene therapies directly to discrete regions of the brain or more broadly to the spinal cord region.

Intellectual Property

VYGR has 21 patent applications pending in the United States and foreign jurisdictions.

At least 18 patent applications have been filed and are pending in the United States and foreign jurisdictions by or on behalf of universities which have granted VYGR exclusive license rights to the technology.

To date, 24 patents have issued to VYGR’s licensors which have granted VYGR exclusive license rights to the technology.

To date, 26 patents have issued to VYGR’s licensors which have granted VYGR non-exclusive license rights to the technology with 12 applications pending.

Competition

VYGR ise aware of several companies focused on developing gene therapies in various indications, including bluebird bio, Inc., Applied Genetic Technologies Corporation, Asklepios BioPharmaceutical, Inc., Audentes Therapeutics, Inc., Avalanche Biotechnologies, Inc., Dimension Therapeutics, Inc., GenSight Biologies SA, NightstaRx Ltd, REGENX, uniQure and Spark Therapeutics, Inc. as well as several companies addressing other methods for modifying genes and regulating gene expression.

Any advances in gene therapy technology made by a competitor may be used to develop therapies that could compete against any of VYGR’s product candidates.

VYGR expects that VY-AADC01 will compete with a variety of therapies currently marketed and in development for advanced Parkinson's disease, including DBS marked by Medtronic plc, St. Jude Medical, Inc. and other medical device companies, DUOPA/Duodopa marketed by AbbVie Inc., as well as potentially AMT-090 or AAV-GDNF in development at uniQure NV, or uniQure, OXB-102/Prosavin in development at Oxford Biomedica plc, and ND0612H in development at NeuroDerm Ltd.

5% Shareholders Pre-IPO

Third Rock Ventures, L.P.          52.6%

Aventis, Inc.           11.2%         

Funds affiliated with Fidelity Management Research Company    7.5%    

Brookside Capital Partners Fund, LP      5.6%    

Funds affiliated with Partners Investments          5.2%    

Dividends

No dividends are planned.

Use of Proceeds

VYGR expects to receive $68 million from its IPO and use it for the following:

$25.0 million to fund the costs of future clinical development, including later-stage clinical trials, and manufacturing of VY-AADC01 for its program for advanced Parkinson's disease;

$30.0 million to fund the costs of additional preclinical development, manufacturing, clinical development, including Phase 1 and later-stage clinical trials, and internal personnel costs for its preclinical programs, including VY-SOD101 for the treatment of a monogenic form of ALS, VY-FXN01 for the treatment of Friedreich's ataxia, VY-HTT01 for the treatment of Huntington's disease and VY-SMN101 for the treatment of SMA; and

the remainder to fund working capital and other general corporate purposes, which may include funding for new research and development activities, the hiring of additional personnel, capital expenditures and the costs of operating as a public company.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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