IPO Report: SteadyMed (STDY)

Francis Gaskins |

SteadyMed IPO, SteadyMed IPO price, SteadyMed IPO date, stocks to buy now, IPOs this week, small-cap stocksSteadyMed (STDY)  is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates.

VLRX is one of four new IPOs scheduled to IPO this week. The full IPO calendar is available at IPOpremium.

The company is based in Rehovot, Israel,and scheduled a $56 million IPO with a market capitalization of $160 million at a price range midpoint of $13, on Nasdaq, for Friday, March 20, 2015.

SEC filings

Manager, Joint-managers: Wells Fargo; RBC

Co-managers: JMP Securities

SteadyMed IPO Overview

STDY is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products in certain orphan and other well-defined, high-margin specialty markets.

The primary focus is to obtain approval for the sale of Trevyent® for the treatment of pulmonary arterial hypertension, or PAH.

SteadyMed IPO Valuation

Glossary

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

             

SteadyMed (STDY)

$160

no rev

-8.4

2.4

2.5

35%

             

SteadyMed IPO Conclusion

Neutral minus

No revenue

P/E of -8.4 indicating moderately heavy cash outflow, relative to market cap

Price-to-book of 2.4

No clinical trials

SteadyMed Business

STDY is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products in certain orphan and other well-defined, high-margin specialty markets.

Primary focus

The primary focus is to obtain approval for the sale of Trevyent® for the treatment of pulmonary arterial hypertension, or PAH.

STDY is also developing two product candidates for the treatment of post-surgical and acute pain in the home setting.

No clinical trials

STDY does not have clinical evidence that removal of meta-cresol from the formulation of treprostinil will reduce or eliminate the experience of injection site reaction seen with Remodulin when administered subcutaneously.

The convenience advantages of Trevyent may not be sufficient to either move market share to STDY or expand the population of PAH patients being prescribed treprostinil

PatchPump

Product candidates are enabled by STDY's proprietary PatchPump, which is a discreet, water-resistant and disposable drug administration technology that is aseptically pre-filled with liquid drug at the site of manufacture and pre-programmed to deliver an accurate, steady flow of drug to a patient, either subcutaneously or intravenously.

SteadyMed Regulatory Approvals

STDY has not received regulatory approvals to sell Trevyent or any of our other product candidates, and STDY has not generated any sales or licensing revenue.

STDY expects to continue to incur significant expenses and increasing operating losses for the foreseeable future as the company continues to develop and seek regulatory approval for product candidates.

SteadyMed Financing

STDY has primarily financed operations, including the development of Trevyent and the scaling up of manufacturing, through the sale of Preferred Shares.

SteadyMed Intellectual Property

As of December 31, 2014, STDY's intellectual property portfolio included three issued U.S. patents and 13 issued foreign patents, as well as seven U.S. pending applications and 10 foreign pending applications relating to PatchPump technology.

SteadyMed Competition

For Trevyent, STDY expects to compete with certain existing infusion treatments for PAH patients with Class II-IV symptoms as well as known products under development:

• Infused Prostacyclins.  This includes the market leader, Remodulin (treprostinil) sold by United Therapeutics Corporation, and other prostacyclins, such as Veletri (epoprostenol) sold by Actelion Ltd., Flolan (epoprostenol) sold by GlaxoSmithKline PLC, and generic epoprostenol sold by Teva Pharmaceutical Industries Ltd.

• Generic Treprostinil.  Sandoz and Teva have filed an abbreviated NDA, or ANDA, for a generic form of treprostinil. We expect the launch of the generic treprostinil to be in late 2017, if not before.

• Semi-Disposable Remodulin Pump.  United Therapeutics recently entered into an early stage research and development collaboration agreement to develop a pre-filled semi-disposable pump system for the subcutaneous delivery of Remodulin.

• Implantable Pump.  Medtronic, Inc. currently sells the Synchromed II implantable pump to deliver baclofen to treat severe spasticity. Under a collaboration between United Therapeutics and Medtronic, Inc., a specially designed delivery catheter is being developed to enable use of the Synchromed II Pump for the delivery of treprostinil, which is subject to regulatory approval.

For AHPA product candidates, STDY expects to compete with certain existing postsurgical pain treatments:

• Elastomeric Pumps.  The On-Q PainBuster, sold by I-Flow LLC, is used to deliver bupivacaine into the surgical wound post-surgery.

• Exparel.  Exparel is sold by Pacira Pharmaceuticals. This is a sustained-release injectable bupivacaine product that provides analgesia local to the wound post-surgery for up to 24 hours.

Opioids and NSAIDs.  The mainstay of pain therapy is opioids, drugs commonly used are morphine, fentanyl, hydrocodone and hydromorphone. In addition, NSAIDs such as ketorolac, diclofenac and ibuprofen are used to treat post-surgical pain.

SteadyMed 5% Shareholders pre-IPO

Brian J. Stark 31%

Brown Bear Holdings LP 9%

Samson Venture Partners I, LLC 13%

SteadyMed Investors, LLC  28%

Entities associated with Deerfield Management Company L.P.  7%

Entities associated with Federated Investors Inc. 7%

SteadyMed Dividends

No dividends planned

SteadyMed IPO Use of Proceeds

STDY expects to net $49mm from its IPO, allocated as follows:

$16.5 million to $19.5 million on pre-commercialization and, if approved, initial commercialization activities for Trevyent, including the manufacturing and validation of registration stability lots and of commercial inventory. STDY expects such proceeds to fund the development and, if approved, commercialization of Trevyent through mid 2016, including the submission of an NDA in the first quarter of 2016.

$8.0 million to $12.0 million on further development of AHPA product candidates, including clinical trials to evaluate performance and safety and to establish a pharmacokinetic relationship between AHPA product candidates and the applicable approved reference listed product. STDY expects such proceeds to commence pre-NDA development of AHPA product candidates through mid 2016.

$3.5 million to $5.0 million on enhancements to the PatchPump delivery system, to broaden its applicability to future product candidates.

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Companies

Symbol Name Price Change % Volume
STDY SteadyMed Ltd. 3.10 -0.10 -3.13 15,094

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